,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32339169,Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study.,"OBJECTIVE


To evaluate the reduction of perineal pain after vaginal deliveries by capacitive resistive radiofrequency therapy (RF).
METHODS


We conducted a double-blind randomized study in University Hospital Centre in France. We included women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not). The participants were randomly assigned to RF or not at day 1 and day 2 postpartum. The primary outcome was pain evaluated as visual analog scale (VAS) score >4 at rest on day 2 after the treatment. Secondary outcomes included discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse were also assessed by phone call 30 days after delivery. We performed univariate analysis and multivariable regressions adjusting on the value of the outcome at baseline to improve precision of the estimated intervention effect.
RESULTS


Between June 1, 2017 and October 8, 2017, the RF group included 29 women compared with 31 women in the group without RF. There was no significant difference on VAS >4 between the two groups (13.8% vs. 9.7% p = 0.69; difference = 4.1%, 95%CI -12.2%- 20.4%); consumption of paracetamol was lower in the RF group (978.3 mg (sd = 804.5) vs 1703.7 mg (sd = 1381.6), p = 0.035; difference = -725.3 mg, 95%CI -1359.6 - -91.3). Multivariate analysis showed no association between RF and pain. Nevertheless, we found an association between RF and discomfort while walking (adjusted OR 0.24, 95% CI 0.07-0.90; p = 0.03).
CONCLUSION


VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery.
CLINICAL TRIAL REGISTRATIONS


The study was registered in the Clinical Government trial (https://clinicaltrials.gov/ct2/show/NCT03172286?term=bretelle&rank=2) under the number NCT03172286.",2020,"VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery.
","['University Hospital Centre in France', 'Between June 1, 2017 and October 8, 2017', 'women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not', 'postpartum perineal pain']","['capacitive resistive radiofrequency therapy (RF', 'Capacitive-resistive radiofrequency therapy']","['perineal discomfort while walking and lower consumption of paracetamol', 'VAS', 'VAS>4', 'discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse', 'RF and pain', 'pain evaluated as visual analog scale (VAS) score', 'consumption of paracetamol', 'perineal pain']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}]","[{'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}]",,0.29121,"VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery.
","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Bretelle', 'Affiliation': 'Department of Gynecology and Obstetrics, AP-HM, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Midwife school, Faculty of medical and paramedical sciences, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Golka', 'Affiliation': 'Midwife school, Faculty of medical and paramedical sciences, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pauly', 'Affiliation': 'Medical Evaluation, Department of Public Health, Assistance Publique-Hôpitaux de Marseille, AMU, Aix- Marseille Université, Marseille, France.'}, {'ForeName': 'Brimbelle', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Medical Evaluation, Department of Public Health, Assistance Publique-Hôpitaux de Marseille, AMU, Aix- Marseille Université, Marseille, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bechadergue', 'Affiliation': 'Department of Gynecology and Obstetrics, AP-HM, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Blanc', 'Affiliation': 'Department of Gynecology and Obstetrics, AP-HM, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}]",PloS one,['10.1371/journal.pone.0231869']
1,32276820,"Corrigendum to ""Fulfilling the psychological and information need of the family members of critically ill patients using interactive mobile technology: A randomized controlled trial"" [Intensive Crit. Care Nurs. 41 (2017) 77-83].",,2020,,['41'],[],[],[],[],[],,0.108797,,"[{'ForeName': 'Vico Chung Lim', 'Initials': 'VCL', 'LastName': 'Chiang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: vico.chiang@polyu.edu.hk.'}, {'ForeName': 'Rainbow Lai Ping', 'Initials': 'RLP', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: rainbow.l.p.lee@polyu.edu.hk.'}, {'ForeName': 'Mei Fung', 'Initials': 'MF', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hmf430@ha.org.hk.'}, {'ForeName': 'Chi Kwong', 'Initials': 'CK', 'LastName': 'Leung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: lck504@ha.org.hk.'}, {'ForeName': 'Pui Yi', 'Initials': 'PY', 'LastName': 'Tang', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: tpy336@ha.org.hk.'}, {'ForeName': 'Sze Wing', 'Initials': 'SW', 'LastName': 'Wong', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: wsw449@ha.org.hk.'}, {'ForeName': 'Sin Yee', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hsy446@ha.org.hk.'}, {'ForeName': 'Wai Yan', 'Initials': 'WY', 'LastName': 'Tung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: twy688a@ha.org.hk.'}, {'ForeName': 'Lai Hang', 'Initials': 'LH', 'LastName': 'Louie', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: LLH389@ha.org.hk.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102833']
2,32340738,"The Effect of Soft Tissue Injury Cold Application Duration on Symptoms, Edema, Joint Mobility, and Patient Satisfaction: A Randomized Controlled Trial.","INTRODUCTION


The aim of this study was to determine the effect of cold application time on symptoms, edema, and patient satisfaction in soft tissue injuries.
METHODS


A randomized controlled trial was conducted with 105 patients who were treated with cold applications of different durations (10, 20, and 30 minutes). Interview-assisted data were collected on symptoms and patient satisfaction. Edema and range of motion were objectively measured in patients with an ankle injury. Data were analyzed using repeated-measures analysis of variance.
RESULTS


Pain reduction was greatest in the 20 minutes of cold application group (F = 46.35, P < 0.05). Symptoms of discomfort such as tingling (F = 65.93, P < 0.05), redness (F = 61.95, P < 0.05), itching (F = 36.49, P < 0.05), numbness (F = 57.94, P < 0.05), and burning (F = 55.40, P < 0.05) were more frequent in the group with 30 minutes of cold application. Both joint mobility (F = 45.28, P < 0.05) and patient satisfaction (F = 130.99, P < 0.05) were the highest in the group with 20 minutes of cold application.
DISCUSSION


Our findings suggest that a duration of 20 minutes for cold application for a soft tissue ankle injury is recommended to maximize pain control, joint mobility, and patient satisfaction while decreasing other symptoms of discomfort.",2020,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","['105 patients who were treated with cold applications of\xa0different durations (10, 20, and 30\xa0minutes', 'patients with an ankle injury']",['Soft Tissue Injury Cold Application Duration'],"['Edema and range of motion', 'joint mobility', 'Symptoms, Edema, Joint Mobility, and Patient Satisfaction', 'numbness', 'patient satisfaction', 'Symptoms of discomfort such as tingling', 'itching', 'symptoms, edema, and patient satisfaction', 'Pain reduction', 'redness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}]","[{'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",,0.111752,"Both joint mobility (F = 45,283, P < 0.05) and patient satisfaction (F = 130,987, P < 0.05) were the highest in the group with 20 minutes of cold application.
","[{'ForeName': 'Senan', 'Initials': 'S', 'LastName': 'Mutlu', 'Affiliation': ''}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.02.017']
3,32340878,Pre-operative Patient Specific Flow Predictions to Improve Haemodialysis Arteriovenous Fistula Maturation (Shunt Simulation Study): A Randomised Controlled Trial.,"OBJECTIVE


An arteriovenous fistula (AVF) needs to mature before it becomes suitable to cannulate for haemodialysis treatment. Maturation importantly depends on the post-operative flow increase. Unfortunately, 20-40% of AVFs fail to mature (FTM). A patient specific computational model that predicts immediate post-operative flow was developed, and it was hypothesised that providing information from this model for planning of fistula creation might reduce FTM rates.
METHODS


A multicentre, randomised controlled trial in nine Dutch hospitals was conducted in which patients with renal failure who were referred for AVF creation, were recruited. Patients were randomly assigned (1:1) to the control or computer simulation group. Both groups underwent a work up, with physical and duplex ultrasonography (DUS) examination. In the simulation group the data from the DUS examination were used for model simulations, and based on the immediate post-operative flow prediction, the ideal AVF configuration was recommended. The primary endpoint was AVF maturation defined as an AVF flow ≥500 mL/min and a vein inner diameter of ≥4 mm six weeks post-operatively. The secondary endpoint was model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve [AUC]).
RESULTS


A total of 236 patients were randomly assigned (116 in the control and 120 in the simulation group), of whom 205 (100 and 105 respectively) were analysed for the primary endpoint. There was no difference in FTM rates between the groups (29% and 32% respectively). Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75).
CONCLUSION


Providing pre-operative patient specific flow simulations during surgical planning does not result in improved maturation rates. Further study is needed to improve the predictive power of these simulations in order to render the computational model an adjunct to surgical planning.",2020,"Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75).
","['236 patients', 'Haemodialysis Arteriovenous Fistula Maturation (Shunt Simulation Study', 'nine Dutch hospitals was conducted in which patients with renal failure who were referred for AVF creation, were recruited']","['Pre-operative Patient Specific Flow Predictions', 'physical and duplex ultrasonography (DUS) examination', 'control or computer simulation group']","['AVF maturation defined as an AVF flow ≥500\xa0mL/min and a vein inner diameter', 'maturation rates', 'FTM rates', 'model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve [AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0398221', 'cui_str': 'Arteriovenous fistulization'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009609', 'cui_str': 'Models, Computer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034980', 'cui_str': 'Analysis, Regression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",236.0,0.142999,"Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75).
","[{'ForeName': 'Niek', 'Initials': 'N', 'LastName': 'Zonnebeld', 'Affiliation': 'Department of Biomedical Engineering, CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: niek.zonnebeld@mumc.nl.'}, {'ForeName': 'Jan H M', 'Initials': 'JHM', 'LastName': 'Tordoir', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'van Loon', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'André A E A', 'Initials': 'AAEA', 'LastName': 'de Smet', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Laurens C', 'Initials': 'LC', 'LastName': 'Huisman', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Almere, the Netherlands.'}, {'ForeName': 'Philippe W M', 'Initials': 'PWM', 'LastName': 'Cuypers', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Felix J V', 'Initials': 'FJV', 'LastName': 'Schlösser', 'Affiliation': 'Department of Surgery, Laurentius Hospital, Roermond, the Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lemson', 'Affiliation': 'Department of Surgery, Slingeland Hospital, Doetinchem, the Netherlands.'}, {'ForeName': 'Stefan G H', 'Initials': 'SGH', 'LastName': 'Heinen', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Bouwman', 'Affiliation': 'Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Raechel J', 'Initials': 'RJ', 'LastName': 'Toorop', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Huberts', 'Affiliation': 'Department of Biomedical Engineering, CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Tammo', 'Initials': 'T', 'LastName': 'Delhaas', 'Affiliation': 'Department of Biomedical Engineering, CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.03.005']
4,32342642,Resting metabolic rate and skeletal muscle SERCA and Na +  /K +  ATPase activities are not affected by fish oil supplementation in healthy older adults.,"Omega-3 polyunsaturated fatty acids (PUFAs) have unique properties purported to influence several aspects of metabolism, including energy expenditure and protein function. Supplementing with n-3 PUFAs may increase whole-body resting metabolic rate (RMR), by enhancing Na +  /K +  ATPase (NKA) activity and reducing the efficiency of sarcoplasmic reticulum (SR) Ca 2+  ATPase (SERCA) activity by inducing a Ca 2+  leak-pump cycle. The purpose of this study was to examine the effects of fish oil (FO) on RMR, substrate oxidation, and skeletal muscle SERCA and NKA pump function in healthy older individuals. Subjects (n = 16 females; n = 8 males; 65 ± 1 years) were randomly assigned into groups supplemented with either olive oil (OO) (5 g/day) or FO (5 g/day) containing 2 g/day eicosapentaenoic acid and 1 g/day docosahexaenoic acid for 12 weeks. Participants visited the laboratory for RMR and substrate oxidation measurements after an overnight fast at weeks 0 and 12. Skeletal muscle biopsies were taken during weeks 0 and 12 for analysis of NKA and SERCA function and protein content. There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups. The kinetic parameters of SERCA and NKA maximal activity, as well as the expression of SR and NKA proteins, were not affected after OO and FO supplementation. In conclusion, these results suggest that FO supplementation is not effective in altering RMR, substrate oxidation, and skeletal muscle SERCA and NKA protein levels and activities, in healthy older men and women.",2020,There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups.,"['healthy older men and women', 'healthy older individuals', 'healthy older adults', 'Subjects (n\xa0=\xa016 females; n\xa0=\xa08 males; 65\xa0±\xa01\xa0years']","['Omega-3 polyunsaturated fatty acids (PUFAs', 'olive oil (OO', 'n-3 PUFAs', 'fish oil (FO', 'FO (5\xa0g/day) containing 2\xa0g/day eicosapentaenoic acid and 1\xa0g/day docosahexaenoic acid', 'FO supplementation']","['RMR', 'RMR, substrate oxidation, and skeletal muscle SERCA and NKA protein levels and activities', 'body resting metabolic rate (RMR), by enhancing Na +  /K +  ATPase (NKA) activity', 'RMR and substrate oxidation measurements', 'fat oxidation', 'RMR, substrate oxidation, and skeletal muscle SERCA and NKA pump function', 'efficiency of sarcoplasmic reticulum (SR) Ca 2+  ATPase (SERCA) activity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036226', 'cui_str': 'Sarcoplasmic reticulum'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0348786,There was a main effect of time with decrease in RMR (5%) and fat oxidation (18%) in both the supplementation groups.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Jannas-Vela', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Klingel', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Cervone', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Wickham', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'George J F', 'Initials': 'GJF', 'LastName': 'Heigenhauser', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Mutch', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Holloway', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14408']
5,32346890,Precision dosing-based optimisation of paroxetine during pregnancy for poor and ultrarapid CYP2D6 metabolisers: a virtual clinical trial pharmacokinetics study.,"OBJECTIVE


Paroxetine has been demonstrated to undergo gestation-related reductions in plasma concentrations, to an extent which is dictated by the polymorphic state of CYP 2D6. However, knowledge of appropriate dose titrations is lacking.
METHODS


A pharmacokinetic modelling approach was applied to examine gestational changes in trough plasma concentrations for CYP 2D6 phenotypes, followed by necessary dose adjustment strategies to maintain paroxetine levels within a therapeutic range of 20-60 ng/ml.
KEY FINDINGS


A decrease in trough plasma concentrations was simulated throughout gestation for all phenotypes. A significant number of ultrarapid (UM) phenotype subjects possessed trough levels below 20 ng/ml (73-76%) compared to extensive metabolisers (EM) (51-53%).
CONCLUSIONS


For all phenotypes studied, there was a requirement for daily doses in excess of the standard 20 mg dose throughout gestation. For EM, a dose of 30 mg daily in trimester 1 followed by 40 mg daily in trimesters 2 and 3 is suggested to be optimal. For poor metabolisers (PM), a 20 mg daily dose in trimester 1 followed by 30 mg daily in trimesters 2 and 3 is suggested to be optimal. For UM, a 40 mg daily dose throughout gestation is suggested to be optimal.",2020,A decrease in trough plasma concentrations was simulated throughout gestation for all phenotypes.,[],"['Paroxetine', 'paroxetine']",['trough plasma concentrations'],[],"[{'cui': 'C0070122', 'cui_str': 'Paroxetine'}]","[{'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0738364,A decrease in trough plasma concentrations was simulated throughout gestation for all phenotypes.,"[{'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Almurjan', 'Affiliation': 'Medicines Optimisation Research Group, Aston Pharmacy School, Aston University, Birmingham, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Macfarlane', 'Affiliation': 'Medicines Optimisation Research Group, Aston Pharmacy School, Aston University, Birmingham, UK.'}, {'ForeName': 'Raj K S', 'Initials': 'RKS', 'LastName': 'Badhan', 'Affiliation': 'Medicines Optimisation Research Group, Aston Pharmacy School, Aston University, Birmingham, UK.'}]",The Journal of pharmacy and pharmacology,['10.1111/jphp.13281']
6,32342648,Do the anatomical and physiological properties of a muscle determine its adaptive response to different loading protocols?,"It has been proposed that superior muscle hypertrophy may be obtained by training muscles predominant in type I fibers with lighter loads and those predominant in type II fibers with heavier loads.
PURPOSE


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


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


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


The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition. Moreover, the study provides further evidence that low-load training is a viable strategy to increase hypertrophy in different human muscles, with hypertrophic increases similar to that observed using heavy loads.",2020,The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition.,['26 untrained young men had their lower limbs randomized to'],"['HEAVY and LIGHT training', 'perform plantarflexion with a low-load (LIGHT) and a high-load (HEAVY']","['isometric strength increases', 'hypertrophic increases in the triceps surae', 'Muscle thickness', 'muscle thickness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",26.0,0.0208311,The triceps surae muscles respond robustly to regimented exercise and measures of muscle hypertrophy and isometric strength appear independent of muscle fiber type composition.,"[{'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vigotsky', 'Affiliation': 'Departments of Biomedical Engineering and Statistics, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Jozo', 'Initials': 'J', 'LastName': 'Grgic', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Haun', 'Affiliation': 'Department of Exercise Science, LaGrange College, LaGrange, GA, USA.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Contreras', 'Affiliation': 'Sport Performance Research Institute, AUT University, Auckland, New Zealand.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Delcastillo', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Aston', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cote', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Alto', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, Bronx, NY, USA.'}]",Physiological reports,['10.14814/phy2.14427']
7,32346816,Agreement Among Paper and Electronic Modes of the EQ-5D-5L.,"INTRODUCTION


While the EQ-5D-5L has been migrated to several electronic modes, evidence supporting the measurement equivalence of the original paper-based instrument to the electronic modes is limited.
OBJECTIVES


This study was designed to comprehensively examine the equivalence of the paper and electronic modes (i.e., handheld, tablet, interactive voice response [IVR], and web).
METHODS


As part of the foundational work for this study, the test-retest reliability of the paper-based, UK English format of the EQ-5D-5L was assessed using a single-group, single-visit, two-period, repeated-measures design. To compare paper and electronic modes, three independent samples were recruited into a three-period crossover study. Each participant was assigned to one of six groups to account for order effects. Descriptive statistics, mean differences (i.e., split-plot analysis of variance [ANOVA]), and intraclass correlation coefficients (ICCs) were calculated.
RESULTS


The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores. For the electronic comparisons, mean difference confidence intervals (CIs) for the EQ-5D index scores and EQ VAS scores reflected equivalence of the means across all modes, as the CIs were wholly contained inside the equivalence interval. Further, the ICC 95% lower CIs for the index and EQ VAS scores showed values above the thresholds for denoting equivalence across all comparisons in each sample. No significant mode-by-order interactions were present in any ANOVA model.
CONCLUSIONS


Overall, our comparisons of the paper, screen-based, and phone-based formats of the EQ-5D-5L provided substantial evidence to support the measurement equivalence of these modes of data collection.",2020,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,[],['EQ-5D-5L'],"['intraclass correlation coefficients (ICCs', 'EQ VAS scores', 'EQ-5D index scores and EQ VAS scores']",[],[],"[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.036839,The test-retest results showed mean differences near zero and ICC values > 0.90 for both the index and the EQ VAS scores.,"[{'ForeName': 'J Jason', 'Initials': 'JJ', 'LastName': 'Lundy', 'Affiliation': 'Outcometrix, 433 Central Avenue, Suite 300, St. Petersburg, FL, 33701, USA. jlundy@outcometrix.com.'}, {'ForeName': 'Stephen Joel', 'Initials': 'SJ', 'LastName': 'Coons', 'Affiliation': 'Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA.'}, {'ForeName': 'Emuella', 'Initials': 'E', 'LastName': 'Flood', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mira J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, White Oak, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The patient,['10.1007/s40271-020-00419-6']
8,32347763,Dupilumab provides rapid and sustained improvement in SCORAD outcomes in adults with moderate-to-severe atopic dermatitis: combined results of four randomized phase 3 trials.,"Background:  Dupilumab, a first-in-class therapy targeting the two key cytokines involved in the persistent underlying inflammatory pathway in atopic dermatitis (AD), is approved for treatment of moderate-to-severe AD in Europe, USA, Japan and several other countries.  Objective:  To assess dupilumab effects on SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD) over time in adults with moderate-to-severe AD.  Methods:  This  post hoc  analysis included 2,444 patients in four placebo-controlled, double-blind, randomized, phase 3 trials. SOLO 1 and 2 (NCT02277743; NCT02277769) evaluated 16 weeks of dupilumab monotherapy against placebo. CAFÉ (NCT02755649) and CHRONOS (NCT02260986) evaluated dupilumab with concomitant topical corticosteroids (TCS) against TCS alone for 16 and 52 weeks, respectively.  Results:  2,444 patients randomized to treatment in SOLO 1 and 2 ( N  = 1,379), CAFÉ ( N  = 325) and CHRONOS ( N  = 740) were analyzed. Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < .0001). These results occurred irrespective of dupilumab regimen, 300 mg subcutaneously weekly or every 2 weeks.  Conclusions:  In four large phase 3 trials in adults with moderate-to-severe AD, dupilumab treatment with or without concomitant TCS resulted in rapid and sustained improvements in all SCORAD outcomes vs. placebo or TCS alone.",2020,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","['2,444 patients randomized to treatment in SOLO 1&2', '2,444 patients in four', 'atopic dermatitis (AD', 'adults with moderate-to-severe atopic dermatitis', 'adults with moderate-to-severe AD']","['dupilumab monotherapy against placebo', 'TCS', 'dupilumab with concomitant topical corticosteroids (TCS) against TCS', 'placebo']","['SCORAD outcomes', 'SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD', 'overall SCORAD and individual components']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",2444.0,0.352091,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Service de Dermatologie, Centre Hospitalier Universitaire de Nantes , Nantes , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University , Munich , Germany.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences , Washington , DC , USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deleuran', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pellacani', 'Affiliation': 'Department of Dermatology, University of Modena and Reggio Emilia , Modena , Italy.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Armario-Hita', 'Affiliation': 'Service of Dermatology, University Hospital of Puerto Real, University of Cádiz , Cádiz , Spain.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi , Chilly-Mazarin , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme , Cambridge , MA , USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1750550']
9,32347139,Leukocyte nadir as a predictive factor for efficacy of adjuvant chemotherapy in breast cancer. Results from the prospective trial SBG 2000-1.,"Background:  Retrospective studies have suggested that chemotherapy-induced leukopenia is associated with improved recurrence-free or overall survival. The SBG 2000-1 trial was designed to verify the favorable prognosis associated with chemotherapy-induced leukopenia in early breast cancer. Patients not experiencing chemotherapy-induced leukopenia were randomized into standard dosed or individually escalated chemotherapy doses based on the grade of leukopenia after a first standard dose. Patients and methods:  1452 women in Sweden and Denmark with operable node-positive or high-risk node-negative breast cancer aged 18-60 years were recruited to participate in this trial. Participants received a first FEC cycle at standard doses (600/60/600 mg/m 2 ). Patients ( n  = 1052) with nadir leukopenia grade 0-2 after the first cycle were randomized between either 6 standard FEC or 6 tailored FEC courses with doses of epirubicin and cyclophosphamide escalated during courses 2 and 3 and thereafter aimed at achieving grade 3 leukopenia. Patients with nadir leukopenia grade 3-4 after the first course continued treatment with standard FEC. Results of the randomized comparison has been published previously. The present study focuses on chemotherapy-induced leukopenia as a covariable with outcome in randomized and non-randomized patients. The prognostic value of leukopenia after course 3, was studied in a Cox model adjusted for cumulative doses of epirubicin and cyclophosphamide. The association of chemotherapy-induced leukopenia with prognosis was a preplanned secondary endpoint for this trial. Results:  The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3-4, respectively. Higher degree of leukopenia was highly significantly associated to improved distant disease-free survival (HR 0.84, 95% CI 0.74-0.96,  p  = .008) and overall survival (HR 0.87 (0.76-0.99,  p  = .032). Conclusion:  This prospective study confirms that chemotherapy-induced leukopenia is a covariable with outcome in primary breast cancer, even after adjustment for chemotherapy doses.",2020,"The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3-4, respectively.","['breast cancer', 'Patients ( n \u2009=\u20091052) with nadir leukopenia grade 0-2 after the first cycle', 'Patients not experiencing chemotherapy-induced leukopenia', 'early breast cancer', '1452 women in Sweden and Denmark with operable node-positive or high-risk node-negative breast cancer aged 18-60\u2009years']","['standard FEC', 'adjuvant chemotherapy', '6 standard FEC or 6 tailored FEC courses with doses of epirubicin and cyclophosphamide', 'epirubicin and cyclophosphamide']","['recurrence-free or overall survival', 'eight-year distant disease-free survival', 'overall survival', 'distant disease-free survival', 'leukopenia']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",,0.119829,"The eight-year distant disease-free survival was 73%, 77%, 78% and 83% for patients with leucocyte nadir grade 0, 1, 2 and 3-4, respectively.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Poikonen-Saksela', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Lindman', 'Affiliation': 'Department of Immunology, Genetics and Pathology University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Asgerdur', 'Initials': 'A', 'LastName': 'Sverrisdottir', 'Affiliation': 'Department of Oncology, Södersjukhuset, Stocholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Edlund', 'Affiliation': 'Department of Oncology, Gävle Hospital, Sweden.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Villman', 'Affiliation': 'Department of Oncology, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Tennvall Nittby', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Cold', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Bechmann', 'Affiliation': 'Department of Oncology, Hospital of South West Jutland, Esbjerg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Stenbygaard', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Blomqvist', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Breast, Endocrine and Sarcoma Section, Cancer Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ahlgren', 'Affiliation': 'Department of Oncology, Gävle Hospital, Sweden.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1757149']
10,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
11,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
12,32348038,Comparative biomechanical testing of customized three-dimensional printing acetabular-wing plates for complex acetabular fractures.,"BACKGROUND


Three-dimensional (3D) printing of an acetabular wing-plate is a new minimally invasive surgical technique for complex acetabular fractures.
OBJECTIVES


To investigate the biomechanical stability of 3D printing acetabular wing-plates. The results were compared with 2 conventional fixation systems.
MATERIAL AND METHODS


Eighteen fresh frozen cadaveric pelvises with both column fractures were randomly divided to 3 groups: A - iliosciatic plates fixation system; B - 3D printing plates; C - 2 parallel reconstruction plates fixation system. These constructions were loaded onto a biomechanical testing machine. Longitudinal displacement and stiffness values of the constructs were measured to estimate their stability.
RESULTS


When the load force reached 700 N, Group A was superior to Group B in the longitudinal displacement of point 1 (p > 0.05). The longitudinal displacement of point 2 showed no significant differences among Groups A, B and C, and the displacement of the fracture line over point 3 showed no significant differences between Groups A and B (p > 0.05). The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively. Group B was significantly stiffer than A and C (p < 0.05). Loads at failure of internal fixation were 1378.83 ±34.383 N, 1516.83 ±30.896 N and 1351.00 ±26.046 N for Groups A, B and C, respectively. Group B was significantly superior to Groups A and C (p > 0.05).
CONCLUSIONS


Customized 3D printing acetabular-wing plates provide stability for acetabular fractures compared to intraspecific buttressing fixation.",2020,"The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively.",['Eighteen fresh frozen cadaveric pelvises with both column fractures'],"[' iliosciatic plates fixation system; B - 3D printing plates; C - 2 parallel reconstruction plates fixation system', 'customized three-dimensional printing acetabular-wing plates']",['displacement of the fracture line'],"[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0559867', 'cui_str': 'Fracture of both columns'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0050322', 'cui_str': 'A(2)C'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",18.0,0.0174596,"The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively.","[{'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Canbin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'UniSA Clinical & Health Sciences, UniSA Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Fuming', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'UniSA Clinical & Health Sciences, UniSA Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}]",Advances in clinical and experimental medicine : official organ Wroclaw Medical University,['10.17219/acem/116749']
13,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0']
14,32345170,Quantitative measurement properties and score interpretation of the Cough Severity Diary in patients with chronic cough.,"AIMS


The Cough Severity Diary (CSD) was developed in accordance with the FDA guidance for patient-reported outcome measures and is focused on capturing the patient's perception of cough in terms of frequency, intensity, and disruption due to their cough. The measure includes a series of seven items asking patients to rate the frequency (three items), intensity (two items), and disruptiveness (two items) of their cough. The instrument was designed to be completed daily before bedtime, has a recall period of 'today,' and responses to items are entered on an 11-point numeric rating scale ranging from 0 to 10 with anchors on each end. The objective of this analysis was to confirm the domain structure of the CSD and assess its reliability, validity, and responsiveness in adult patients with refractory or unexplained chronic cough (RCC/UCC). Criteria for defining meaningful changes in mean weekly CSD total and domain scores in the context of a clinical trial were also developed.
METHODS


Pooled data from a phase II randomized controlled trial of an investigational treatment for RCC/UCC were analyzed. Participants were non-smokers, had RCC/UCC for ⩾1 year, and a baseline cough severity visual analogue scale (VAS) ⩾40 mm. CSD scores (baseline, week 4), were analyzed; the Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts were used for validation. CSD domain structure (Total, Frequency, Intensity, Disruption) was assessed for scoring.
RESULTS


A total of 253 participants were included (mean age 60.2; 76% female). Global fit of the three-factor CSD was acceptable. For the CSD total score, internal consistency (α = 0.89) and test-retest reliability (intraclass correlation coefficient = 0.68) were high. CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84). Participants with a PGIC score of 1 or 2 (most improved groups) had the greatest mean score improvement on the CSD Total (Day 0 to Day 28), supporting responsiveness (similar findings for subscales). A change threshold of ⩾1.3-point reduction on the total and subscale scores is appropriate to define clinically meaningful improvement.
CONCLUSION


The CSD is a reliable, valid, and responsive measure of cough symptom severity in patients with refractory or unexplained chronic cough and fit-for-purpose for assessing changes in cough severity in clinical trials.  The reviews of this paper are available via the supplemental material section.",2020,CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84).,"['adult patients with refractory or unexplained chronic cough (RCC/UCC', 'patients with refractory or unexplained chronic cough', 'Participants were non-smokers, had RCC/UCC for ⩾1\u2009year, and a baseline cough severity visual analogue scale (VAS) ⩾40\u2009mm', 'patients with chronic cough', 'A total of 253 participants were included (mean age 60.2; 76% female']",[],"['CSD total scores', 'cough severity VAS', 'CSD scores', 'Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts', 'CSD total score, internal consistency', 'Cough Severity Diary (CSD', 'CSD domain structure (Total, Frequency, Intensity, Disruption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",253.0,0.032168,CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84).,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Martin Nguyen', 'Affiliation': 'Merck Sharp & Dohme Corp., 770 Sumneytown Pike, West Point, PA 19486 USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bacci', 'Affiliation': 'Evidera Inc, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dicpinigaitis', 'Affiliation': 'Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Vernon', 'Affiliation': 'Evidera Inc, Bethesda, MD, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620915155']
15,32345747,Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD.,"BACKGROUND AND OBJECTIVES


Kidney functional magnetic resonance imaging (MRI) requires further investigation to enhance the noninvasive identification of patients at high risk of CKD progression.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


In this exploratory study, we obtained baseline diffusion-weighted and blood oxygen level-dependent MRI in 122 participants of the CKD Optimal Management with Binders and Nicotinamide trial, which was a multicenter, randomized, double-blinded, 12-month, four-group parallel trial of nicotinamide and lanthanum carbonate versus placebo conducted in individuals with eGFR 20-45 ml/min per 1.73 m 2 . Lower values of apparent diffusion coefficient (ADC) on diffusion-weighted MRI may indicate increased fibrosis, and higher values of relaxation rate (R2*) on blood oxygen level-dependent MRI may represent decreased oxygenation. Because there was no effect of active treatment on eGFR over 12 months, we tested whether baseline kidney functional MRI biomarkers were associated with eGFR decline in all 122 participants. In a subset of 87 participants with 12-month follow-up MRI data, we evaluated whether kidney functional MRI biomarkers change over time.
RESULTS


Mean baseline eGFR was 32±9 ml/min per 1.73 m 2 , and mean annual eGFR slope was -2.3 (95% confidence interval [95% CI], -3.4 to -1.1) ml/min per 1.73 m 2  per year. After adjustment for baseline covariates, baseline ADC was associated with change in eGFR over time (difference in annual eGFR slope per 1 SD increase in ADC: 1.3 [95% CI, 0.1 to 2.5] ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.04). This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.08). There was no significant association between baseline R2* and change in eGFR over time. In 87 participants with follow-up functional MRI, ADC and R2* values remained stable over 12 months (intraclass correlation: 0.71 and 0.68, respectively).
CONCLUSIONS


Baseline cortical ADC was associated with change in eGFR over time, but this association was not independent of albuminuria. Kidney functional MRI biomarkers remained stable over 1 year.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


CKD Optimal Management with Binders and Nicotinamide (COMBINE), NCT02258074.",2020,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.08).","['Individuals with CKD', '122 participants of the CKD Optimal Management with Binders and Nicotinamide trial', 'conducted in individuals with eGFR 20-45 ml/min per 1.73 m 2 ', '87 participants with 12-month follow-up MRI data', 'patients at high risk of CKD progression']",['nicotinamide and lanthanum carbonate versus placebo'],"['relaxation rate', 'kidney functional MRI biomarkers change over time', 'blood oxygen level', 'baseline kidney functional MRI biomarkers', 'mean annual eGFR slope', 'Kidney functional MRI biomarkers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",87.0,0.570967,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.08).","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois anand.srivastava@northwestern.edu.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kendrick', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Michel B', 'Initials': 'MB', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Division of Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Dallas, Texas.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, Renal Section, University of San Diego, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Pottumarthi V', 'Initials': 'PV', 'LastName': 'Prasad', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13201019']
16,32348306,Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial.,"INTRODUCTION


Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting. We aimed to evaluate the long-term (104 week) efficacy following a standard course of inpatient-initiated varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone.
METHODS


Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals, were randomised to receive either 12-weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling, (n = 196) or Quitline-counselling alone, (n = 196), with continuous abstinence from smoking assessed at 104 weeks.
RESULTS


A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011. The proportion of participants who remained continuously abstinent (intention-to-treat) at 104 weeks were significantly greater in the varenicline tartrate plus counselling arm (29.2% n = 56) compared to counselling alone (18.8% n = 36; p = 0.02; odds ratio 1.78; 95%CI 1.10 to 2.86, p = 0.02). Twenty-two deaths occurred during the 104 week study (n = 10 for varenicline tartrate plus counselling and n = 12 for Quitline-counselling alone). All of these participants had known or developed underlying co-morbidities.
CONCLUSIONS


This is the first study to examine the efficacy and safety of varenicline tartrate over 104 weeks within any setting. Varenicline tartrate plus Quitline-counselling was found to be an effective opportunistic treatment when initiated for inpatient smokers who had been admitted with tobacco-related disease.",2020,"INTRODUCTION


Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting.","['A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011', 'inpatient smoking cessation (STOP study', 'inpatient smokers who had been admitted with tobacco-related disease', 'Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals']","['varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone', 'varenicline tartrate', 'Varenicline tartrate plus Quitline-counselling', 'varenicline tartrate plus counselling', 'Quitline-counselling alone', 'varenicline tartrate and counselling', 'Varenicline tartrate', 'varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling']",['efficacy and safety'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1711887', 'cui_str': 'Varenicline tartrate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0708476,"INTRODUCTION


Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting.","[{'ForeName': 'Kristin V', 'Initials': 'KV', 'LastName': 'Carson-Chahhoud', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, The University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Smith', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Thoracic Medicine, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Malcolm P', 'Initials': 'MP', 'LastName': 'Brinn', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, The University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ameer', 'Affiliation': 'Respiratory Medicine, Ipswich Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Kuljit', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fitridge', 'Affiliation': 'Division of Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Koblar', 'Affiliation': 'Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Jannes', 'Affiliation': 'Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Antony J', 'Initials': 'AJ', 'LastName': 'Veale', 'Affiliation': 'Respiratory Medicine Department, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldsworthy', 'Affiliation': 'Pharmacy Department, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Hnin', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Esterman', 'Affiliation': 'School of Nursing and Midwifery, The University of South Australia, Adelaide, South Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0231095']
17,32289841,Effects of Body Weight vs. Lean Body Mass on Wingate Anaerobic Test Performance in Endurance Athletes.,"The aim of this study was to determine the influence of body weight or lean body mass-based load on Wingate Anaerobic Test performance in male and female endurance trained individuals. Thirty-one participants (22 male cyclists and triathletes and 9 female triathletes) completed two randomized Wingate Anaerobic Test (body weight and lean body mass loads) in stationary start. There were no significant differences in power outputs variables between loads in any group. However, when comparing specific groups within the sample (e. g. cyclists vs cyclists) medium to large effect sizes were observed for Relative Mean Power Output (ES=0.53), Relative Lowest Power (ES=0.99) and Relative Power Muscle Mass (ES=0.54). Regarding gender differences, male cyclists and triathletes displayed higher relative and absolute power outputs (p<0.001) compared to female triathletes regardless of the protocol used. FI was lower in female triathletes compared to male triathletes and cyclists in body weight (p<0.001) and lean body mass (p<0.01) protocols. Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders. These results suggest that using either body weight-based or lean body mass-based load can be used interchangeably. However, there may be some practically relevant differences when evaluating this on an individual level.",2020,"Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders.","['Thirty-one participants (22 male cyclists and triathletes and 9 female triathletes', 'male and female endurance trained individuals', 'Endurance Athletes']","['body weight or lean body mass-based load', 'Body Weight vs. Lean Body Mass']",['Body composition and anthropometric characteristics'],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}]",31.0,0.070604,"Body composition and anthropometric characteristics were similar in male cyclists and triathletes, but there were differences between genders.","[{'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Rioja', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'González-Mohíno', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'Dajo', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Human Movement Science, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Mellado', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'González-Ravé', 'Affiliation': 'Sport Training Lab., Faculty of Sport Sciences, University of Castilla-La Mancha, Campus of Toledo, Spain.'}]",International journal of sports medicine,['10.1055/a-1114-6206']
18,30232416,Ghrelin is impacted by the endogenous circadian system and by circadian misalignment in humans.,"The human circadian system regulates hunger independently of behavioral factors, resulting in a trough in the biological morning and a peak in the biological evening. However, the role of the only known orexigenic hormone, ghrelin, in this circadian rhythm is unknown. Furthermore, although shift work is an obesity risk factor, the separate effects of the endogenous circadian system, the behavioral cycle, and circadian misalignment on ghrelin has not been systematically studied. Here we show-by using two 8-day laboratory protocols-that circulating active (acylated) ghrelin levels are significantly impacted by endogenous circadian phase in healthy adults. Active ghrelin levels were higher in the biological evening than the biological morning (fasting +15.1%, P = 0.0001; postprandial +10.4%, P = 0.0002), consistent with the circadian variation in hunger (P = 0.028). Moreover, circadian misalignment itself (12-h behavioral cycle inversion) increased postprandial active ghrelin levels (+5.4%; P = 0.04). While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05). Our results provide possible mechanisms for the endogenous circadian rhythm in hunger, as well as for the increased risk of obesity among shift workers.",2019,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).",['healthy adults'],[],"['Active ghrelin levels', 'postprandial active ghrelin levels', 'circadian variation in hunger', 'hunger']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]",,0.0482443,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. jqian@bwh.harvard.edu.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Garaulet', 'Affiliation': 'Department of Physiology, Chronobiology Laboratory, University of Murcia and Research Biomedical Institute of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. fscheer@bwh.harvard.edu.""}]",International journal of obesity (2005),['10.1038/s41366-018-0208-9']
19,32343642,"Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group.","PURPOSE


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


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


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


I/T/DIN/GM-CSF has significant antitumor activity in patients with relapsed/refractory neuroblastoma. Study of chemoimmunotherapy in the frontline setting is indicated, as is further evaluation of predictive biomarkers.",2020,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","['Seventeen eligible patients', ""patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group"", 'Patients were eligible at first relapse or first designation of refractory disease', 'Children With Refractory or Relapsed Neuroblastoma', 'patients with relapsed/refractory neuroblastoma']","['Irinotecan, Temozolomide, and Dinutuximab With GM-CSF', 'chemoimmunotherapy', 'irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF', 'Oral T and intravenous (IV) irinotecan']","['Higher DIN trough levels', 'diarrhea', 'objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria', 'neutropenia', 'response rate and toxicity', 'Objective (complete or partial) responses', 'overall survival', 'toxicity', 'fever/infection', 'stable disease', 'pain', 'antitumor activity', 'Objective responses']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0278695', 'cui_str': 'Neuroblastoma recurrent'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0930635,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","[{'ForeName': 'Rajen', 'Initials': 'R', 'LastName': 'Mody', 'Affiliation': ""C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Yu', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""St Jude Children's Research Hospital and University of Tennessee Health Science Center, Memphis, TN.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Sabah-E-Noor', 'Initials': 'SE', 'LastName': 'Servaes', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Diccianni', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Felder', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Birstler', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Asgharzadeh', 'Affiliation': ""Children's Hospital of Los Angeles and University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Glade-Bender', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Katzenstein', 'Affiliation': ""Nemour's Children's Clinic, Jacksonville, FL.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00203']
20,32349005,A Randomized Controlled Comparison of Epidural Analgesia Onset Time and Adverse Reactions During Labor With Different Dose Combinations of Bupivacaine and Sufentanil.,"OBJECTIVES


The purpose was to compare the effects of 3 different dose combinations of bupivacaine and sufentanil on the onset of analgesia and the occurrence of side effects.
MATERIALS AND METHODS


One hundred sixty-nine pregnant women were randomly assigned to 3 groups: the B1S5 group received 0.1% bupivacaine+5 μg sufentanil in 15 mL; the B125S5 group received 0.125% bupivacaine+5 μg sufentanil in 15 mL; and the B1S10 group received 0.1% bupivacaine+10 μg sufentanil in 15 mL. The primary outcome was the analgesic onset time, and the secondary outcomes were mode of delivery, patient satisfaction, maternal and neonatal side effects (pruritus, hypotension, sedation, motor block, decreased fetal heart rate, fever, and interference with breastfeeding).
RESULTS


The median (inter-quartile range) time to achieve effective analgesia was significantly faster in the B125S5 group than in the B1S5 group (10 [11-14 {4-30}] min vs. 15 [17-20 {5-30}] min, P<0.001). There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 [11-14 {4-30}] min vs. 12 [13-15 {3-30}] min, P=0.202). Pruritus, hypotension, motor block, maternal satisfaction, delivery mode, decreased fetal heart rate, total bupivacaine dose and breastfeeding scores were not significantly different among the 3 groups except the sufentanil dosage and incidence of mild drowsiness and fever (the B1S10 group had significantly higher fever than the other groups).
DISCUSSION


The B125S5 combination may be superior to the B1S5 and B1S10 combinations as an initial dose for epidural analgesia to achieve rapid effective analgesia with minimal side effects.",2020,"There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 (11-14 [4-30]) min vs. 12 (13-15 [3-30]) min, P=0.202).",['One hundred sixty-nine pregnant women'],"['Bupivacaine and Sufentanil', 'B1S10 group received 0.1% bupivacaine + 10▒μg sufentanil', 'B1S5 group received 0.1% bupivacaine + 5▒μg sufentanil', 'B125S5 group received 0.125% bupivacaine + 5▒μg sufentanil', 'bupivacaine and sufentanil']","['mild drowsiness and fever', 'analgesic onset time, and the secondary outcomes were mode of delivery, patient satisfaction, maternal and neonatal side effects (pruritus, hypotension, sedation, motor block, decreased fetal heart rate, fever and breast feeding', 'Epidural Analgesia Onset Time and Adverse Reactions', 'Pruritus, hypotension, motor block, maternal satisfaction, delivery mode, decreased fetal heart rate, total bupivacaine dose and breastfeeding scores', 'median (IQR [range]) time to achieve effective analgesia', 'analgesia onset time']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517427', 'cui_str': '0.125'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",169.0,0.114634,"There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 (11-14 [4-30]) min vs. 12 (13-15 [3-30]) min, P=0.202).","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yaojun', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, TN.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000837']
21,32351412,Dissociable Effects of Theta-Burst Repeated Transcranial Magnetic Stimulation to the Inferior Frontal Gyrus on Inhibitory Control in Nicotine Addiction.,"Nicotine addiction, like other substance use disorders (SUD's), is associated with deficits in prefrontal mediated inhibitory control. The strength of inhibitory control task-based functional connectivity (tbFC) between the right inferior frontal gyrus (r.IFG) and thalamus (corticothalamic circuit) mediates the association between successful inhibition and smoking relapse vulnerability. However, the potential efficacy of theta burst stimulation (TBS) to the r.IFG, a treatment known to alter clinical symptoms among neuropsychiatric patients, has not been reported in a SUD population. This study utilized fMRI guided neuronavigation to examine the effects of TBS on inhibitory control among nicotine dependent individuals. Participants ( N =12) were scanned while performing an inhibitory control task known to elicit inhibition-related activity in the r.IFG. Using a randomized, counterbalanced cross-over design, participants then received TBS over two visits: excitatory (iTBS) on one visit and inhibitory (cTBS) TBS on the other visit. The effects of each TBS condition on subsequent inhibitory control task performance were examined. A significant condition x time interaction was identified on trials requiring inhibitory control (F (1,10) = 7.27,  p  = .022,  D  = 1.63). iTBS improved inhibitory control, whereas cTBS impaired inhibitory control. Brain stimulation did not influence performance in control conditions including novelty detection and response execution. This is the first study to demonstrate that non-invasive neural stimulation using iTBS to the r.IFG enhances baseline inhibitory control among individuals with a SUD. Further research is needed to directly examine the potential parametric effects of TBS on corticothalamic tbFC in individuals with a SUD.",2020,The strength of inhibitory control task-based functional connectivity (tbFC) between the right inferior frontal gyrus (r.IFG) and thalamus (corticothalamic circuit) mediates the association between successful inhibition and smoking relapse vulnerability.,"['Nicotine Addiction', 'nicotine dependent individuals', 'individuals with a SUD', 'neuropsychiatric patients']","['theta burst stimulation (TBS', 'Theta-Burst Repeated Transcranial Magnetic Stimulation', 'TBS over two visits: excitatory (iTBS', 'TBS', 'IFG']","['novelty detection and response execution', 'strength of inhibitory control task-based functional connectivity (tbFC', 'subsequent inhibitory control task performance']","[{'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",12.0,0.013428,The strength of inhibitory control task-based functional connectivity (tbFC) between the right inferior frontal gyrus (r.IFG) and thalamus (corticothalamic circuit) mediates the association between successful inhibition and smoking relapse vulnerability.,"[{'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Newman-Norlund', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Makayla', 'Initials': 'M', 'LastName': 'Gibson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'McConnell', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Froeliger', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, SC, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00260']
22,32353174,Physical activity and cognition in young-onset Parkinson's disease.,"BACKGROUND


A relationship has been observed between physical activity and cognition in older-onset Parkinson's disease, as well as improvements in cognition after a physical activity intervention. To date, this has not been investigated in young-onset Parkinson's disease (YOPD).
OBJECTIVES


To examine the baseline relationship between physical activity and cognition in YOPD; and to examine whether a physical activity intervention can improve cognition in YOPD.
METHODS


Two interrelated online studies were conducted. In the first study, 132 participants with YOPD completed self-reported measures of physical activity, and objective and subjective measures of cognition. A subset of 38 participants was then randomly allocated to either a six-week physical activity intervention or control condition. Following the intervention, participants repeated the objective and subjective cognitive measures.
RESULTS


No relationship was found between self-reported physical activity and objective cognition; however, there was a relationship between physical activity and subjective cognition. Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not for memory. Furthermore, medium effect sizes were evident for objective measures of processing speed and small-medium effect sizes for planning and cognitive flexibility, although statistical significance was not reached.
CONCLUSIONS


In this first study investigating physical activity and cognition in YOPD, the results suggest that increased physical activity relates to improved processing speed and attention. Replication is recommended with a larger sample size. A longer, more intense physical activity manipulation and utilizing the study's strengths of online recruitment and intervention delivery are also recommended.",2020,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","['38 participants', ""young onset Parkinson's disease (YOPD"", ""young onset Parkinson's disease"", '132 participants with YOPD completed']","['physical activity intervention', 'six-week physical activity intervention or control condition']","['physical activity and objective cognition', 'Physical activity and cognition', 'physical activity and subjective cognition', 'processing speed and small-medium effect sizes for planning and cognitive flexibility', 'objective and subjective cognitive measures', 'self-report measures of physical activity, and objective and subjective measures of cognition', 'concentration, attention, and processing speed, but not memory']","[{'cui': 'C4275179', 'cui_str': 'Young onset Parkinson disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",132.0,0.0152447,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Biddiscombe', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ong', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kalinowski', 'Affiliation': 'Cogstate, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerryn E', 'Initials': 'KE', 'LastName': 'Pike', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",Acta neurologica Scandinavica,['10.1111/ane.13256']
23,32353206,Effects of individual pelvic floor muscle training vs individual training progressing to group training vs group training alone in women with stress urinary incontinence: A randomized clinical trial.,"AIMS


To assess the effects of individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training in women with stress urinary incontinence (SUI).
METHODS


Randomized controlled and pragmatic clinical trials with 90 women with SUI. Participants were randomly allocated to one of three groups: IT, GT, or four individual sessions progressing to group training (IPGT). The intervention included 12 sessions, once a week, with direct supervision by a physical therapist.
PRIMARY OUTCOME


severity according to the King's Health Questionnaire.
SECONDARY OUTCOMES


PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy. Reassessments were conducted at the end of the intervention, 3 and 6 months after the intervention. Intra- and intergroup analysis for all outcomes was performed using a multivariate analysis of variance. In the mixed-effects model used, the evaluation groups and times and their interactions were considered. A significance level of 5% was adopted.
RESULTS


After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56). The benefits of the intervention were maintained 3 and 6 months after the end of the supervised training (P < .001). The IPGT group had a significant improvement in PFM function when compared to the other groups posttreatment (P < .001).
CONCLUSION


PFM training improved the severity of urinary incontinence in all groups after 12 sessions of training supervised by a physical therapist. IT progressing to GT improved the function of upper PFM when compared to the other groups.",2020,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","['women with stress urinary incontinence (SUI', 'women with stress urinary incontinence', '90 women with SUI']","['IT, GT, or four individual sessions progressing to group training (IPGT', 'individual pelvic floor muscle training vs individual training progressing to group training vs group training alone', 'individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training', 'PFM training', 'direct supervision by a physical therapist']","['PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy', 'severity of urinary incontinence', 'PFM function', 'severity measure', 'function of upper PFM', ""severity according to the King's Health Questionnaire""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.0228563,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","[{'ForeName': 'Vilena B', 'Initials': 'VB', 'LastName': 'Figueiredo', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Simony L', 'Initials': 'SL', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Renata F L', 'Initials': 'RFL', 'LastName': 'Martínez', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Clara T S', 'Initials': 'CTS', 'LastName': 'Lima', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of Ceará (UFC), Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Cristine H J', 'Initials': 'CHJ', 'LastName': 'Ferreira', 'Affiliation': 'Department of Health Sciences, Health Science Department, University of São Paulo (USP), Ribeirão Preto-SP, São Paulo, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24370']
24,32353342,"Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial.","BACKGROUND


Patients with HER2-positive breast cancer who have received two or more previous therapies for advanced disease have few effective treatment options. The monarcHER trial aimed to compare the efficacy of abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab in women with advanced breast cancer.
METHODS


This phase 2, three-group, open-label trial was done across 75 hospitals, clinics, and medical centres in 14 countries. Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease. Patients were randomly assigned 1:1:1 to the abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab (group C). Oral abemaciclib 150 mg 12 hourly was administered on days 1-21 of a 21-day cycle, intravenous trastuzumab 8 mg/kg on cycle 1 day 1, followed by 6 mg/kg on day 1 of each subsequent 21-day cycle, and intramuscular fulvestrant 500 mg on days 1, 15, and 29 and once every 4 weeks thereafter. Standard-of-care chemotherapy was administered as specified by the product label. Randomisation was by a computer-generated random sequence by means of an interactive web-response system and stratified by number of previous systemic therapies for advanced breast cancer and measurable versus non-measurable disease. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, first testing group A versus group C and, if this result was significant, then group B versus group C. Safety was assessed in all patients who had received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov (NCT02675231) and is ongoing for long-term survival follow-up.
FINDINGS


Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients were enrolled and randomly assigned to groups A (n=79), B (n=79), and C (n=79). Median follow-up was 19·0 months (IQR 14·7-25·1). The study met its primary endpoint, showing a significant difference at the prespecified two-sided α of 0·2 in median progression-free survival between group A (8·3 months, 95% CI 5·9-12·6) and group C (5·7 months, 5·4-7·0; HR 0·67 [95% CI 0·45-1·00]; p=0·051). No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77). The most common grade 3-4 treatment-emergent adverse event in groups A, B, and C was neutropenia (21 [27%] of 78 patients, 17 [22%] of 77, and 19 [26%] of 72). The most common serious adverse events were: in group A, pyrexia (three [4%]), diarrhoea (two [3%]), urinary tract infection (two [3%]), and acute kidney injury (two [3%]); in group B, diarrhoea (two [3%]) and pneumonitis (two [3%]); and in group C, neutropenia (four [6%]) and pleural effusion (two [3%]). Two deaths were attributed to treatment: one due to pulmonary fibrosis in group B and one due to febrile neutropenia in group C.
INTERPRETATION


The combination of abemaciclib, fulvestrant, and trastuzumab significantly improved progression-free survival versus standard-of-care chemotherapy plus trastuzumab while showing a tolerable safety profile. Our results suggest that a chemotherapy-free regimen might potentially be an alternative treatment option for patients with hormone receptor-positive, HER2-positive advanced breast cancer.
FUNDING


Eli Lilly and Company.",2020,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","['women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER', '75 hospitals, clinics, and medical centres in 14 countries', 'patients with hormone receptor-positive, HER2-positive advanced breast cancer', 'Patients with HER2-positive breast cancer', 'Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients', 'women with advanced breast cancer', 'Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease']","['Standard-of-care chemotherapy', ""abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab"", 'Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy', 'Oral abemaciclib', 'abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab']","['pneumonitis', 'febrile neutropenia', 'neutropenia', 'median progression-free survival', 'progression-free survival', 'acute kidney injury', 'diarrhoea', 'pyrexia', 'urinary tract infection', 'pleural effusion', 'investigator-assessed progression-free survival']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",325.0,0.211064,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: sara_tolaney@dfci.harvard.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wardley', 'Affiliation': 'The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Istituto Di Ricovero e Cura a Carattere Scientifico, Ospedale San Raffaele, IRCCS, Milano, Italy.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, PSL Research University, Department of Medical Oncology, Paris, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Stephen Rd', 'Initials': 'SR', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-WA, Nedlands, WA, Australia; Curtin University, Nedlands, WA, Australia.'}, {'ForeName': 'Shom', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Catron', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Gustave Roussy, Université Paris Saclay, INSERM, Villejuif, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30112-1']
25,32378340,Changes in strength and power performance and serum hormone concentrations during 12 weeks of task-specific or strength training in conscripts.,"The purpose of this study was to investigate the effects of two different training programs on strength and power performance and serum hormone concentrations. A total of 104 male soldiers volunteered and took part in the 12-week training period with baseline, mid-, and post-measurements of body composition, muscle strength, lower and upper body power, and blood samples to determine serum hormone concentrations. The mean (±SD) age of subjects was 20 ± 1 years, height 180 ± 6 cm and body mass 72.4 ± 8.8 kg. The subjects were divided into three different training groups: soldier task-specific training (TS), strength training (ST), and control (CON). Each group had a total of 18 training sessions during the 12-week study. In the muscle strength tests, most improvements could be observed in the TS and ST groups, especially, during the first weeks of the training period. Maximal isometric leg extension force increased significantly by 7.9 ± 12.2% (p < .05) in the TS and 7.1 ± 12.6% (p < .05) in the ST groups between the PRE and MID, as well as between the PRE and POST measurements by 8.1 ± 12.4% (p < .05) in TS and 12.3 ± 15.3% (p < .01) in ST. Serum TES concentration increased significantly in TS between the PRE and MID (16.8 ± 33.9%) and PRE and POST (11.2 ± 16.7%) measurements. Serum COR concentrations decreased in TS between the MID and POST (-7.8 ± 10.9%) and PRE and POST (-11.0 ± 14.3%) measurements. Although the differences observed were rather minor in magnitude, training in the TS and ST groups led to greater improvements in muscle strength and power performance compared to the training in the CON group. The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance. Therefore, it is important to have a structured resistance-training program during military training to optimize the strength, power, and military-specific performance.",2020,"The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance.","['The mean (±SD) age of subjects was 20\xa0±\xa01\xa0years, height 180\xa0±\xa06\xa0cm and body mass 72.4\xa0±\xa08.8\xa0kg', '104 male soldiers volunteered and took part']","['soldier task-specific training (TS), strength training (ST), and control (CON', 'POST']","['Serum TES concentration', 'Maximal isometric leg extension force', 'strength and power performance and serum hormone concentrations', 'strength and/or power of the lower and upper body', 'Serum COR concentrations', 'muscle strength and power performance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",104.0,0.0128887,"The development of strength and/or power of the lower and upper body was greater in the TS and ST groups, which is crucial for warfighter's performance.","[{'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Ojanen', 'Affiliation': 'Finnish Defence Research Agency, Finnish Defence Forces, Järvenpää, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kozharskaya', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Biology of Physical Activity, University of Jyväskylä, Jyväskylä, Finland.'}]",Physiological reports,['10.14814/phy2.14422']
26,32353536,Agreement of Spectral-Domain OCT with Fluorescein Leakage in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.,"PURPOSE


To evaluate the agreement between detection of activity of choroidal neovascularization (CNV) in neovascular age-related macular degeneration (AMD) by fundus fluorescein angiography (FFA) and spectral-domain (SD) OCT in the HARBOR study. Most retina specialists rely on OCT to guide treatment decisions in neovascular AMD. However, OCT may not always detect exudative activity. Traditionally, FFA was frequently performed in clinical practice, but its use has diminished due to reliance on OCT.
DESIGN


Retrospective post hoc analysis of prospective clinical trial (HARBOR; ClinicalTrials.gov identifier, NCT00891735).
PARTICIPANTS


Patients with neovascular AMD in the HARBOR Trial.
METHODS


Baseline to month 24 data from all randomized study eyes in HARBOR with both FFA and SD OCT data were analyzed for (1) evidence of CNV activity on SD OCT (presence of subretinal fluid, intraretinal fluid, and/or cystoid spaces); (2) evidence of CNV activity on FFA identified by the presence of leakage, and (3) cross-tabulation of CNV activity identified by FFA and SD OCT by office visit.
MAIN OUTCOME MEASURES


The percent agreement between FFA and SD OCT in detecting CNV activity and sensitivity and specificity of SD OCT to detect fluorescein leakage in neovascular AMD using FFA as the reference standard.
RESULTS


At baseline, 1094 patients (99.9%) had agreement between SD OCT and FFA in detecting CNV activity. By month 24, of the 779 total active cases, the agreement was only 36% (277 cases). By month 24, most cases (n = 452 [58%]) had evidence of CNV activity on SD OCT only, whereas 6% of cases (n = 50) had CNV activity identified by FFA only. At screening and months 3, 6, 12, and 24, 92% to 100% of cases identified by FFA only were occult CNV lesions. Using FFA as the reference standard, the sensitivity and specificity of SD OCT in detecting CNV activity was 91% (95% confidence interval [CI], 84%-99%) and 13% (95% CI, 4%-22%).
CONCLUSIONS


Spectral-domain OCT alone can be relied upon for detecting CNV activity while monitoring eyes with neovascular AMD. However, FFA may still be of value in those with occult lesions that appear quiescent on SD OCT, as this type of lesion may show leakage on FFA.",2020,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","['neovascular age-related macular degeneration (AMD) by fundus', 'Neovascular Age-related Macular Degeneration', ' Baseline to Month 24 data from all randomized study eyes in HARBOR with both FFA and SD-OCT data']","['Spectral Domain Optical Coherence Tomography with Fluorescein Leakage', 'FFA', 'fluorescein angiography (FFA) and spectral domain (SD)- optical coherence tomography (OCT', 'choroidal neovascularization (CNV', 'OCT']","['CNV activity', 'occult CNV lesions', 'CNV activity on SD-OCT', 'sensitivity and specificity of SD-OCT in detecting CNV activity']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}]","[{'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",,0.0420517,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.016']
27,32299310,Introduction to the special edition on the placebo effect in sport and exercise.,,2020,,[],[],[],[],[],[],,0.0453474,,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beedie', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'Florentina', 'Initials': 'F', 'LastName': 'Hettinga', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-Upon-Tyne, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1757682']
28,32358697,Moderators of School Intervention Outcomes for Children with Autism Spectrum Disorder.,"A prior cluster randomized controlled trial (RCT) compared outcomes for a comprehensive school intervention (schoolMAX) to typical educational programming (services-as-usual [SAU]) for 103 children with autism spectrum disorder (ASD) without intellectual disability. The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms). In the current study, a range of demographic, clinical, and school variables were tested as potential moderators of treatment outcomes from the prior RCT. Moderation effects were not evident in demographics, child IQ, language, or ASD diagnostic symptoms, or school SES. Baseline externalizing symptoms moderated the outcome of social-cognitive understanding and adaptive skills moderated the outcome of ASD-related symptoms (no other comorbid symptoms or adaptive skills ratings moderated outcomes on the three measures). Overall, findings suggest that the main effects of treatment were, with two exceptions, unaffected by third variables.",2020,"The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms).","['Children with Autism Spectrum Disorder', '103 children with autism spectrum disorder (ASD) without intellectual disability']",['comprehensive school intervention (schoolMAX) to typical educational programming (services-as-usual [SAU'],"['demographics, child IQ, language, or ASD diagnostic symptoms, or school SES', 'social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0557796', 'cui_str': 'Comprehensive school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",103.0,0.0390846,"The schoolMAX intervention was superior to SAU in improving social-cognitive understanding (emotion-recognition), social/social-communication skills, and ASD-related impairment (symptoms).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lopata', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA. lopatac@canisius.edu.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Thomeer', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Rodgers', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lodi-Smith', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Booth', 'Affiliation': 'Institute for Autism Research, Canisius College, Science Hall 1016C, 2001 Main Street, Buffalo, NY, 14208, USA.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Volker', 'Affiliation': 'Center for Research in Autism, Intellectual, and Other Neurodevelopmental Disabilities, Michigan State University, East Lansing, MI, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00652-5']
29,32358862,"Effect of a 12-week endurance training program on force transfer and membrane integrity proteins in lean, obese, and type 2 diabetic subjects.","The mechanisms accounting for the loss of muscle function with obesity and type 2 diabetes are likely the result of a combination of neural and muscular factors. One muscular factor that is important, yet has received little attention, is the protein machinery involved in longitudinal and lateral force transmission. The purpose of this study was to compare the levels of force transfer and membrane integrity proteins before and after a 12-week endurance training program in lean, obese, and obese type 2 diabetic adults. Nineteen sedentary subjects (male = 8 and female = 11) were divided into three groups: Lean (n = 7; 50.3 ± 4.1 y; 69.1 ± 7.2 kg); Obese (n = 6; 49.8 ± 4.1 y; 92.9 ± 19.5 kg); and Obese with type 2 diabetes (n = 6; 51.5 ± 7.9 years; 88.9 ± 15.1 kg). Participants trained 150 min/week between 55% and 75% of VO 2max  for 12 weeks. Skeletal muscle biopsies were taken before and after the training intervention. Baseline dystrophin and muscle LIM protein levels were higher (~50% p < .01) in lean compared to obese and type 2 diabetic adults, while the protein levels of the remaining force transfer and membrane integrity proteins were similar between groups. After training, obese individuals decreased (-53%; p < .01) the levels of the muscle ankyrin repeat protein and lean individuals decreased dystrophin levels (-45%; p = .01), while the levels of the remaining force transfer and membrane integrity proteins were not affected by training. These results suggest that there are modest changes to force transfer and membrane integrity proteins in middle-aged individuals as a result of 12 weeks of lifestyle and training interventions.",2020,"After training, obese individuals decreased (-53%; p < .01)","['lean, obese, and obese type 2 diabetic adults', 'lean, obese, and type 2 diabetic subjects', 'Nineteen sedentary subjects (male\xa0=\xa08 and female\xa0=\xa011) were divided into three groups: Lean (n\xa0=\xa07; 50.3\xa0±\xa04.1 y; 69.1\xa0±\xa07.2\xa0kg); Obese (n\xa0=\xa06; 49.8\xa0±\xa04.1 y; 92.9\xa0±\xa019.5\xa0kg); and Obese with type 2 diabetes (n\xa0=\xa06; 51.5\xa0±\xa07.9\xa0years; 88.9\xa0±\xa015.1\xa0kg', 'middle-aged individuals']",['endurance training program'],"['dystrophin levels', 'Baseline dystrophin and muscle LIM protein levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0290137', 'cui_str': 'cysteine and glycine-rich protein 3'}]",19.0,0.0197282,"After training, obese individuals decreased (-53%; p < .01)","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Jannas-Vela', 'Affiliation': 'Exercise Physiology Laboratory, School of Kinesiology, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Henning T', 'Initials': 'HT', 'LastName': 'Langer', 'Affiliation': 'Department of Neurobiology, Physiology and Behavior, University of California, Davis, CA, USA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Marambio', 'Affiliation': 'Centro de Salud Deportiva, Clinica Santa Maria, Santiago, Chile.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baar', 'Affiliation': 'Department of Neurobiology, Physiology and Behavior, University of California, Davis, CA, USA.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Zbinden-Foncea', 'Affiliation': 'Exercise Physiology Laboratory, School of Kinesiology, Universidad Finis Terrae, Santiago, Chile.'}]",Physiological reports,['10.14814/phy2.14429']
30,32359490,"Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


In ARIEL3, rucaparib maintenance treatment significantly improved progression-free survival versus placebo. Here, we report prespecified, investigator-assessed, exploratory post-progression endpoints and updated safety data.
METHODS


In this ongoing (enrolment complete) randomised, placebo-controlled, phase 3 trial, patients aged 18 years or older who had platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 who had received at least two previous platinum-based chemotherapy regimens and responded to their last platinum-based regimen were randomly assigned (2:1) to oral rucaparib (600 mg twice daily) or placebo in 28-day cycles using a computer-generated sequence (block size of six with stratification based on homologous recombination repair gene mutation status, progression-free interval following penultimate platinum-based regimen, and best response to most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary endpoint of investigator-assessed progression-free survival has been previously reported. Prespecified, exploratory outcomes of chemotherapy-free interval (CFI), time to start of first subsequent therapy (TFST), time to disease progression on subsequent therapy or death (PFS2), and time to start of second subsequent therapy (TSST) and updated safety were analysed (visit cutoff Dec 31, 2017). Efficacy analyses were done in all patients randomised to three nested cohorts: patients with BRCA mutations, patients with homologous recombination deficiencies, and the intention-to-treat population. Safety analyses included all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT01968213.
FINDINGS


Between April 7, 2014, and July 19, 2016, 564 patients were enrolled and randomly assigned to rucaparib (n=375) or placebo (n=189). Median follow-up was 28·1 months (IQR 22·0-33·6). In the intention-to-treat population, median CFI was 14·3 months (95% CI 13·0-17·4) in the rucaparib group versus 8·8 months (8·0-10·3) in the placebo group (hazard ratio [HR] 0·43 [95% CI 0·35-0·53]; p<0·0001), median TFST was 12·4 months (11·1-15·2) versus 7·2 months (6·4-8·6; HR 0·43 [0·35-0·52]; p<0·0001), median PFS2 was 21·0 months (18·9-23·6) versus 16·5 months (15·2-18·4; HR 0·66 [0·53-0·82]; p=0·0002), and median TSST was 22·4 months (19·1-24·5) versus 17·3 months (14·9-19·4; HR 0·68 [0·54-0·85]; p=0·0007). CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts. The most frequent treatment-emergent adverse event of grade 3 or higher was anaemia or decreased haemoglobin (80 [22%] patients in the rucaparib group vs one [1%] patient in the placebo group). Serious treatment-emergent adverse events were reported in 83 (22%) patients in the rucaparib group and 20 (11%) patients in the placebo group. Two treatment-related deaths have been previously reported in this trial; there were no new treatment-related deaths.
INTERPRETATION


In these exploratory analyses over a median follow-up of more than 2 years, rucaparib maintenance treatment led to a clinically meaningful delay in starting subsequent therapy and provided lasting clinical benefits versus placebo in all three analysis cohorts. Updated safety data were consistent with previous reports.
FUNDING


Clovis Oncology.",2020,"CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts.","['0·54-0·85', 'patients randomised to three nested cohorts: patients with BRCA mutations, patients with homologous recombination deficiencies, and the intention-to-treat population', 'Between April 7, 2014, and July 19, 2016, 564 patients', 'patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3', 'patients who received at least one dose of study treatment', 'patients aged 18 years or older who had platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 who had received at least two previous platinum-based chemotherapy regimens and responded to their last platinum-based regimen']","['rucaparib', 'oral rucaparib', 'Rucaparib', 'placebo in 28-day cycles using a computer-generated sequence (block size of six with stratification based on homologous recombination repair gene mutation status, progression-free interval following penultimate platinum-based regimen', 'placebo']","['median PFS2', 'progression-free survival', 'CFI, TFST, PFS2, and TSST', 'median CFI', 'investigator-assessed progression-free survival', 'Serious treatment-emergent adverse events', 'anaemia or decreased haemoglobin', 'chemotherapy-free interval (CFI), time to start of first subsequent therapy (TFST), time to disease progression on subsequent therapy or death (PFS2), and time to start of second subsequent therapy (TSST) and updated safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",564.0,0.619906,"CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts.","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Gynecologic Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology,St John of God Subiaco Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Division of Gynecologic Oncology, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Gynecologic Oncology Unit, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Faculty of Medicine, University of Queensland, St Lucia, QLD, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'Division of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clinical Science, Clovis Oncology UK, Cambridge, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clinical Development, Clovis Oncology, Boulder, CO, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Biostatistics, Clovis Oncology, Boulder, CO, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30061-9']
31,32358602,Comments on Aydin et al: The Effectiveness of Dry Needling and Exercise Therapy in Patients with Dizziness Caused by Cervical Myofascial Pain Syndrome; a Prospective Randomized Clinical Study.,,2020,,['Patients with Dizziness Caused by Cervical Myofascial Pain Syndrome'],['Dry Needling and Exercise Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0458110', 'cui_str': 'Myofascial pain syndrome of neck'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.0162506,,"[{'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Rehabilitation Sciences and Physiotherapy Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Vereeck', 'Affiliation': 'Rehabilitation Sciences and Physiotherapy Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'De Vestel', 'Affiliation': 'Rehabilitation Sciences and Physiotherapy Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Van Rompaey', 'Affiliation': 'Translational Neurosciences, Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Castien', 'Affiliation': 'General Practice & Elderly Care Medicine, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa119']
32,32358610,"Authors' Reply: Letter to the Editor Regarding ""The Effectiveness of Dry Needling and Exercise Therapy in Patients with Dizziness Caused by Cervical Myofascial Pain Syndrome; Prospective Randomized Clinical Study"".",,2020,,['Patients with Dizziness Caused by Cervical Myofascial Pain Syndrome'],['Dry Needling and Exercise Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0458110', 'cui_str': 'Myofascial pain syndrome of neck'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.0201219,,"[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Aydın', 'Affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Karacan', 'Affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa116']
33,32363775,Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis.,"BACKGROUND/OBJECTIVE


Oncology guidelines recommend earlier communication with patients about prognosis and goals-of-care in serious illness. However, current evidence leaves gaps in our understanding of the experience of these conversations. This analysis evaluates the patient and clinician experience of a conversation using a Serious Illness Conversation Guide (SICG).
DESIGN/SETTING


Secondary analysis from a cluster-randomized clinical trial in a northeastern cancer center.
PARTICIPANTS


Physicians, advanced practice clinicians, and patients with advanced cancer who received the intervention.
INTERVENTION


SICG, clinician training, systems-changes.
MAIN OUTCOMES AND MEASURES


The patient questionnaire assessed perceptions of the conversation and impact on anxiety, hopefulness, peacefulness, sense of control over medical decisions, closeness with their clinician, and behaviors. The clinician questionnaire assessed feasibility, acceptability, and impact on satisfaction in their role.
RESULTS


We enrolled 54 clinicians and 163 patients; 41 clinicians and 118 patients had a SICG discussion. Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician. Qualitative patient data described positive behavior changes, including enhanced planning for future care and increased focus on personal priorities. Nearly 90% of clinicians agreed that the SICG facilitated timely, effective conversations, and 70% reported increased satisfaction in their role.
CONCLUSION


Conversations using a SICG were feasible, acceptable, and were associated with positive experiences for both patients and clinicians in oncology in ways that align with national recommendations for serious illness communication. This trial is registered at ClinicalTrials.gov: NCT01786811 https://clinicaltrials.gov/ct2/show/NCT01786811.",2020,"Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician.","['Patient and clinician experience of a serious illness conversation guide in oncology', 'Secondary analysis from a cluster-randomized clinical trial in a northeastern cancer center', 'We enrolled 54 clinicians and 163 patients; 41 clinicians and 118 patients had a SICG discussion', 'Physicians, advanced practice clinicians, and patients with advanced cancer who received the intervention']",[],"['satisfaction', 'clinician questionnaire assessed feasibility, acceptability, and impact on satisfaction', 'sense of peacefulness, hopefulness, and anxiety', 'anxiety, hopefulness, peacefulness, sense of control over medical decisions, closeness with their clinician, and behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021783', 'cui_str': 'External-Internal Control'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",54.0,0.0775545,"Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Koritsanszky', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Nisotel', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Benjamin', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fromme', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Cancer medicine,['10.1002/cam4.3102']
34,32362168,Dietary advice and oral nutritional supplements do not increase survival in older malnourished adults: a multicentre randomised controlled trial.,"Objectives:  The study aimed to investigate the effect on survival after 6 months of treatment involving individual dietary advice and oral nutritional supplements in older malnourished adults after discharge from hospital. Methods:  This multicentre randomised controlled trial included 671 patients aged 65 years who were malnourished or at risk of malnutrition when admitted to hospital between 2010 and 2014, and followed up after 8.2 years (median 4.1 years). Patients were randomised to receive dietary advice or oral nutritional supplements, separate or in combination, or routine care. The intervention started at discharge from the hospital and continued for 6 months, with survival being the main outcome measure. Results:  During the follow-up period 398 (59.3%) participants died. At follow-up, the survival rates were 36.9% for dietary advice, 42.4% for oral nutritional supplements, 40.2% for dietary advice combined with oral nutritional supplements, and 43.3% for the control group (log-rank test  p  = 0.762). After stratifying the participants according to nutritional status, survival still did not differ significantly between the treatment arms (log-rank test  p  = 0.480 and  p  = 0.298 for the 506 participants at risk of malnutrition and the 165 malnourished participants, respectively). Conclusions:  Oral nutritional supplements with or without dietary advice, or dietary advice alone, do not improve the survival of malnourished older adults. These results do not support the routine use of supplements in older malnourished adults, provided that survival is the aim of the treatment. Trial registration:  ClinicalTrials.gov with ID: NCT01057914.",2020,"At follow-up, the survival rates were 36.9% for dietary advice, 42.4% for oral nutritional supplements, 40.2% for dietary advice combined with oral nutritional supplements, and 43.3% for the control group (log-rank test  p  = 0.762).","['671 patients aged 65\u2009years who were malnourished or at risk of malnutrition when admitted to hospital between 2010 and 2014, and followed up after 8.2\u2009years (median 4.1\u2009years', 'older malnourished adults', 'malnourished older adults', 'older malnourished adults after discharge from hospital']","['dietary advice or oral nutritional supplements, separate or in combination, or routine care', 'individual dietary advice and oral nutritional supplements', 'Oral nutritional supplements with or without dietary advice, or dietary advice alone', 'ID', 'Dietary advice and oral nutritional supplements']","['survival rates', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",671.0,0.165764,"At follow-up, the survival rates were 36.9% for dietary advice, 42.4% for oral nutritional supplements, 40.2% for dietary advice combined with oral nutritional supplements, and 43.3% for the control group (log-rank test  p  = 0.762).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Söderström', 'Affiliation': 'Centre for Clinical Research, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenblad', 'Affiliation': 'Department of Statistics, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bergkvist', 'Affiliation': 'Centre for Clinical Research, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Frid', 'Affiliation': 'Department of Child and Adolescence Psychiatry, Västmanland Hospital, Västerås, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Thors Adolfsson', 'Affiliation': 'Centre for Clinical Research, Region Västmanland, Uppsala University, Västerås, Sweden.'}]",Upsala journal of medical sciences,['10.1080/03009734.2020.1751752']
35,32361279,Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.,"BACKGROUND


Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI).
METHODS


We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications.
RESULTS


A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm.
CONCLUSIONS


In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.",2020,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","['A total of 17 studies with 11,992 patients were included in the current TSA', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction']","['TRA', 'transradial access (TRA) versus transfemoral access (TFA', 'percutaneous coronary intervention', 'Radial versus femoral access']","['MI and stroke', '30-day mortality, major bleeding, MACE and access site complication rates', '30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications', 'major bleeding', '30-day mortality', 'access site complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",11992.0,0.316525,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA. Electronic address: Mohammed.Osman@hsc.wvu.edu.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Khansa', 'Initials': 'K', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Babikir', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Regner', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Qais', 'Initials': 'Q', 'LastName': 'Radaideh', 'Affiliation': 'Division of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Moreland', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Department of Cardiovascular Medicine, Cleveland Clinic, OH, USA.'}]",American heart journal,['10.1016/j.ahj.2020.03.014']
36,32365242,"Non-invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator-initiated, phase IV, unicentric, open, randomized clinical trial.","BACKGROUND


Treatment response for psoriasis is typically evaluated using clinical scores. However, patients can relapse after clinical clearance, suggesting persistent inflammation. Dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) can non-invasively improve treatment response assessment.
OBJECTIVES


To compare the clinical and non-invasive microscopic features in a psoriatic target lesion treated with clobetasol cream or calcipotriol/betamethasone dipropionate foam (Cal/BD foam).
METHODS


Prospective, unicentric, open, randomized clinical trial comparing clinical data [total clinical score (TCS)] and microscopic data (dermoscopy, RCM and OCT) in psoriasis patients treated with clobetasol or Cal/BD foam.
RESULTS


We included 36 adult patients (22 men). At week 4, more patients treated with Cal/BD foam achieved TCS ≤1 than with clobetasol (63.2% vs. 18.8%, P = 0.016). Treatment satisfaction was higher with Cal/BD foam (P < 0.03). Microscopically, Cal/BD foam induced more reduction in epidermal thickness at week 4 (P < 0.049). Dilated horizontal blood vessels were more common with clobetasol than with Cal/BD foam at week 8 (69.2% vs. 31.2%, P = 0.159). If epidermal hyperplasia was noted at baseline, the response was poorer with clobetasol (P = 0.029).
LIMITATIONS


Small sample size, open study, imaging sampling bias.
CONCLUSION


Cal/BD foam is more effective than clobetasol, has better patient satisfaction and induces greater reduction in the hyperkeratosis/acanthosis, regardless of baseline epidermal hyperplasia.",2020,"Microscopically, Cal/BD-foam induced more reduction of epidermal thickness at week 4 (p<0.049).","['mild to moderate plaque psoriasis', '36 adult patients (22 men', 'psoriasis patients treated with clobetasol or Cal/BD-foam']","['clobetasol cream versus calcipotriol/betamethasone dipropionate foam', 'clobetasol cream or calcipotriol/betamethasone dipropionate foam']","['Dilated horizontal blood vessels', 'microscopic data (dermoscopy, RCM, OCT', 'Treatment satisfaction', 'Dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT', 'reduction of epidermal thickness', 'epidermal hyperplasia']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0263641', 'cui_str': 'Epithelial hyperplasia of skin'}]",36.0,0.0802139,"Microscopically, Cal/BD-foam induced more reduction of epidermal thickness at week 4 (p<0.049).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Yélamos', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Alejo', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seda Ertekin', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Villa-Crespo', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zamora-Barquero', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martinez', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Domínguez', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Iglesias', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Herrero', 'Affiliation': ""Dermatology Department, Hospital Clínic, Institut d'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Malvehy', 'Affiliation': 'CIBER de Enfermedades Raras, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'CIBER de Enfermedades Raras, Instituto de Salud Carlos III, Madrid, Spain.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16559']
37,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION


Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users.
METHODS


ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms.
RESULTS


We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups.
CONCLUSIONS


A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
38,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
39,32366071,[Peptide bioregulators: delivery and efficacy].,"PURPOSE


To compare the neuroprotective properties of retinalamin administered in different ways among open-angle glaucoma patients with compensated intraocular pressure.
MATERIAL AND METHODS


The study included 498 patients (eyes) with initial, moderate and advanced stages of glaucoma. Patients were divided into 3 groups: group I ( n =110) received 5 mg intramuscular and 5 mg retrobulbar injections of retinalamin; group II ( n =171) received 5 mg retrobulbar injection of retinalamin; group III received 5 mg intramuscular injection of retinalamin. The overall treatment dose contained 50 mg of retinalamin. All the patients underwent tonometry and static perimetry. Patients of group II with initial glaucoma and patients of group III with moderate glaucoma also underwent contrast sensitivity tests. The examinations were conducted before the treatment, and on months 3 and 6.
RESULTS


Visual acuity did not change significantly. In group I, after 3 months of treatment total threshold retinal sensitivity increased by 122 dB in patients with initial glaucoma, by 166 dB in moderate and by 124 dB in advanced glaucoma. Positive trend was observed in patients with initial and moderate stages of glaucoma by month 6. In group II, total threshold retinal sensitivity increased by 123 dB in initial glaucoma and by 110 dB in moderate; the result did not change by month 6. No significant changes were observed in patients with advanced glaucoma. In group III, total threshold retinal sensitivity increased by 142 dB in initial glaucoma, by 274 dB in moderate and by 148 dB in advanced glaucoma. Regression began on the sixth month. In group II, patients with initial glaucoma were observed to have decreased sensorimotor reaction times to achromatic stimuli within the studied areas of central visual field. In group III, patients with advanced glaucoma were also observed to have decreased sensorimotor reaction times to achromatic stimuli detected within 1° and 5° areas from the fixation point, but not in the 10° area.
CONCLUSION


Retinalamin is most effective in initial and moderate glaucoma stages. Intramuscular, retrobulbar and combined administration methods have comparable efficacy.",2020,"In group I, after 3 months of treatment total threshold retinal sensitivity increased by 122 dB in patients with initial glaucoma, by 166 dB in moderate and by 124 dB in advanced glaucoma.","['498 patients (eyes) with initial, moderate and advanced stages of glaucoma', 'open-angle glaucoma patients with compensated intraocular pressure', 'patients with advanced glaucoma', 'Patients of group II with initial glaucoma and patients of group III with moderate glaucoma also underwent contrast sensitivity tests']","['Retinalamin', '5 mg intramuscular and 5 mg retrobulbar injections of retinalamin', '5 mg retrobulbar injection of retinalamin; group III received 5 mg intramuscular injection of retinalamin', 'retinalamin']","['Visual acuity', 'retinal sensitivity', 'total threshold retinal sensitivity', 'sensorimotor reaction times to achromatic stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0846621', 'cui_str': 'Contrast sensitivity test'}]","[{'cui': 'C1610354', 'cui_str': 'retinalamin'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0196999', 'cui_str': 'Retrobulbar injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",498.0,0.0150106,"In group I, after 3 months of treatment total threshold retinal sensitivity increased by 122 dB in patients with initial glaucoma, by 166 dB in moderate and by 124 dB in advanced glaucoma.","[{'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Erichev', 'Affiliation': 'Research Institute of Eye Diseases, Moscow, Russia.'}, {'ForeName': 'Dzh N', 'Initials': 'DN', 'LastName': 'Lovpache', 'Affiliation': 'Ophthalmological Clinic 3Z, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Yaremenko', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}]",Vestnik oftalmologii,['10.17116/oftalma202013602156']
40,32374272,Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study.,"BACKGROUND


Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations.
OBJECTIVE


The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect.
METHODS


We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35).
RESULTS


The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups.
CONCLUSIONS


High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain.",2020,"For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001) with results strengthening after two weeks.","['participants who completed at least one of eight surveys administered during the intervention period: VR (n=39) and Audio (n=35', 'online convenience sample of adults (N=97) 18-65 years of age with self-reported chronic non-malignant chronic low back pain or fibromyalgia with an average pain intensity > 4 over the past month, and chronic pain duration > 6 months', 'acute pain', 'chronic pain', 'Chronic Pain', 'Patients with chronic pain', 'Methods']","['self-administered VR program', 'Self-Administered Skills-Based Virtual Reality Intervention', 'RCT', 'Virtual reality (VR', 'VR: a 21-day, skills-based VR program for chronic pain; and (2) Audio: an audio-only version of the 21-day VR program', 'VR program']","['average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy', 'pain-catastrophizing and pain self-efficacy', 'nausea or motion sickness', 'feasibility and acceptability', 'High satisfaction ratings', 'pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress', 'pain outcomes', 'average pain intensity', 'adverse effects']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0617575,"For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001) with results strengthening after two weeks.","[{'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'C.T. Bauer College of Business, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Tsuei', 'Affiliation': 'AppliedVR, Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Jorge D', 'Initials': 'JD', 'LastName': 'Minor', 'Affiliation': 'L.A. Pain & Wellness Institute, Los Angeles, CA, United States.'}]",JMIR formative research,['10.2196/17293']
41,32308903,Timing Considerations for Noninvasive Vagal Nerve Stimulation in Clinical Studies.,"Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders. n-VNS devices are known to affect physiological signals, and, recently, they have been employed in various protocols involving both acute and longitudinal applications. However, questions regarding response time, ""dosage,"" or optimal treatment paradigms remain open. Prior work evaluated noninvasively obtained biomarkers that quantify the stimulation efficacy based on the changes in autonomic tone in a randomized double-blind study. In this work, we extend the state-of-the-art by investigating the onset of action for n-VNS in these same physiological biomarkers through a three-day clinical trial, including 233 administrations on 24 human participants, with and without immediately preceding acute traumatic stress. Determining n-VNS latency serves as a substantial step toward optimizing stimulation delivery with higher temporal resolution for personalized neuromodulation.",2019,Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders.,"['patients with stress-related psychiatric disorders', '24 human participants, with and without immediately preceding acute traumatic stress']",['Noninvasive vagal nerve stimulation (n-VNS'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]",[],24.0,0.0486448,Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders.,"[{'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Scott', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}]",AMIA ... Annual Symposium proceedings. AMIA Symposium,[]
42,32360666,Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.,"OBJECTIVES


Evaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20-35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD) during the first postpartum year.
STUDY DESIGN


We conducted a one-year multicenter, non-randomized, non-inferiority, open-label, comparative trial at 20 centers in India and compared efficacy, safety, continuation and LA plus feeding patterns and growth/well-being of participants' infants. Women used four 3-month PVRs consecutively (lost PVRs were not replaced) and were to breastfeed at least four times/day. We used Pearl Index (PI) and Kaplan Meier (K-M) rates to analyze pregnancy and K-M for continuation.
RESULTS


We enrolled 789 women (459 PVR, 330 IUD). Neither PI nor K-M one-year pregnancy rates differed significantly between groups (PI: PVR-0.62; IUD-0.35); (K-M: PVR-0.7; IUD-0.4, p = 0.58). Continuation rates at 12 months were 78.5% (IUD) vs. 56.9% (PVR) (p < 0.001). Ring expulsions and menorrhagia were the most common discontinuation among PVR/IUD users respectively. The median duration of LA among PVR vs. IUD users was 405 vs. 120 days (p < 0.001). Both groups reported similar adverse events (PVR: 24.2%; IUD: 23.0%); there were no serious adverse events among PVR users. Infants from both groups fed 12-7 times/day and grew at expected rates.
CONCLUSIONS


Efficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups.
IMPLICATIONS


PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.",2020,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","['lactating women', 'lactating mothers', '789 women (459 PVR, 330 IUD', 'married lactating women (20-35 years) using the', ""participants' infants""]","['progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD', 'Progesterone vaginal ring']","['PI nor K-M one-year pregnancy rates', 'median duration of LA', 'Continuation rates', 'Pearl Index (PI) and Kaplan Meier (K-M) rates', 'Efficacy and safety outcomes', 'adverse events', 'contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0473315', 'cui_str': 'Lactational amenorrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",789.0,0.262346,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","[{'ForeName': 'Malabika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India. Electronic address: malaroy69@gmail.com.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Merkatz', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Plagianos', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Mohcine', 'Initials': 'M', 'LastName': 'Alami', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gaur', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Kumudha', 'Initials': 'K', 'LastName': 'Aruldas', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sussman', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Government Medical College, SMGS Hospital, Jammu, India; Postgraduate Institute of Medical Education and Research Chandigarh, India; Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India; K.G. Medical University, Lucknow, India; Motilal Nehru Medical College and Hospital, Prayagraj, India; GSVM Medical College and Hospital, Kanpur, India; SMS Medical College and Zanana Hospital, Jaipur, India; Institute of Obstetrics and Gynecology, Madras Medical College, Chennai, India; Government Medical College and SAT Hospital, Thiruvananthapuram, India; Jawaharlal Nehru Medical College and Hospital, Belagavi, India; Patna Medical College and Hospital, Patna, India; R.G. Kar Medical College and Hospital, Kolkata, India; Medical College and Eden Hospital, Kolkata, India; SCB Medical College and Hospital, Cuttack, India; Seth GS Medical College and KEM Hospital, Mumbai, India; KEM Hospital, Pune, India; Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India; Goa Medical College and Hospital, Goa, India; Indian Council of Medical Research - National Institute for Research in Reproductive Health, Mumbai, India.'}]",Contraception,['10.1016/j.contraception.2020.04.016']
43,32369401,Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.,"PURPOSE


Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions.
METHODS


We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed.
RESULTS


In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM  v  85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05];  P  = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4%  v  10.3%; HR, 1.16 [95% CI, 0.69 to 1.98];  P  = .57) and site-reported time to AF (21.9%  v  18.9%; HR, 1.31 [95% CI, 0.86 to 2.01];  P  = .21) also did not differ by arm.
CONCLUSION


To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.",2020,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM  v  85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05];  P  = .18).","['Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months', 'Women', '724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline']","['text messaging (TM) versus no text messaging (No-TM', 'Adjuvant Aromatase Inhibitor Therapy', 'Text Messaging']","['time to AF', 'time to adherence failure (AF', 'rates of AI AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",724.0,0.166451,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM  v  85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05];  P  = .18).","[{'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Grace Clarke', 'Initials': 'GC', 'LastName': 'Hillyer', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP/Cancer Center of Kansas - Wichita, Wichita, KS.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Esparaz', 'Affiliation': 'Heartland NCORP/Cancer Care Specialist of Central Illinois, Decatur, IL.'}, {'ForeName': 'Ming C', 'Initials': 'MC', 'LastName': 'Kuan', 'Affiliation': 'Kaiser Permanente NCORP/Kaiser Permanente NCAL, San Leandro, CA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Southeast COR NCORP/Waverly Hematology/Oncology, Cary, NC.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Lackowski', 'Affiliation': 'Northwest NCORP/Central Interstate Medical Office Department Hematology/Oncology, Portland, OR.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Edenfield', 'Affiliation': 'NCORP of the Carolinas (Greenville Health System), Greenville, SC.'}, {'ForeName': 'Zoneddy R', 'Initials': 'ZR', 'LastName': 'Dayao', 'Affiliation': 'New Mexico Minority Underserved NCORP/University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance/University of Washington, Seattle, WA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Ramsey', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alfred I', 'Initials': 'AI', 'LastName': 'Neugut', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02699']
44,32360827,Axillary vein puncture guided by ultrasound vs cephalic vein dissection in pacemaker and defibrillator implant: A multicenter randomized clinical trial.,"BACKGROUND


Axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator lead insertion.
OBJECTIVE


The purpose of this study was to evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant.
METHODS


This prospective, multicenter clinical trial included 88 adult patients randomized 1:1 to US-Ax (n = 44) or CV (n = 44). All procedures were performed by operators with no previous experience in axillary approach. Primary endpoint was defined as success rate. Secondary endpoints were venous access site change, time to obtain venous access, total procedural time, and early complication rate. Analyses were performed using the intention-to-treat principle.
RESULTS


Median age was 70.5 years (58.2-79.7), and 60.2% were male. For the primary outcome, a higher success rate was observed in the axillary group (97.7% vs 54.5%; P <.001), as well as a lower rate of venous access site change (2.3% vs 40.9%; P <.001) and shorter time to obtain venous access (5 vs 15 minutes; P <.001) and procedural time (40 vs 51 minutes; P = .010), with no difference in complication rate (2.3% vs 11.4%; P =.20). In multivariate analysis, US-Ax (P <.001), single-chamber device (P = .015), and body mass index (P = .015) were independent predictors of overall success.
CONCLUSION


This is the first randomized trial comparing self-learned US-Ax to CV in cardiac lead implantation. Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.",2020,"Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.","['Median age was 70.5 years (58.2-79.7), and 60.2% were males', '88 adult patients randomized 1:1 to US-Ax (n=44) or CV (n=44']","['Axillary vein puncture guided by ultrasound versus cephalic vein dissection', 'axillary vein puncture guided by ultrasound (US-Ax', 'cephalic vein dissection (CV']","['rate of venous access site change', 'success rate, time to obtain venous access and procedural time, with similar complication rate', 'body mass index', 'procedural time', 'venous access site change, time to obtain venous access, total procedural time, and early complication rate', 'higher success rate', 'complication rate', 'success rate', 'shorter time to obtain venous access']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",88.0,0.216018,"Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Tagliari', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil. Electronic address: anapaulatagliari@yahoo.com.br.'}, {'ForeName': 'Adriano Nunes', 'Initials': 'AN', 'LastName': 'Kochi', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Mastella', 'Affiliation': 'Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Rodrigo Petersen', 'Initials': 'RP', 'LastName': 'Saadi', 'Affiliation': 'Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'di Leoni Ferrari', 'Affiliation': 'Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Keller', 'Initials': 'EK', 'LastName': 'Saadi', 'Affiliation': 'Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil; Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Carisi Anne', 'Initials': 'CA', 'LastName': 'Polanczyk', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Cardiology Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}]",Heart rhythm,['10.1016/j.hrthm.2020.04.030']
45,32371430,"Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies.","BACKGROUND/OBJECTIVE


FKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (RA) inadequately controlled with methotrexate (MTX). A subsequent randomised open-label extension (OLE) study with treatment switching assessed long-term safety, efficacy, pharmacokinetics and immunogenicity of FKB327 compared with the RP.
METHODS


Patients with moderate-to-severe, active RA on a stable dose of MTX were randomised 1:1 to receive FKB327 or the RP (40 mg subcutaneously every other week) for 24 weeks. Patients who completed the DB study were enrolled in the OLE and rerandomised 2:1 to receive FKB327 or the RP; two-thirds continued on the same treatment and one-third switched for 30 weeks. All patients received FKB327 through Week 76. Long-term efficacy, safety and immunogenicity were assessed.
RESULTS


Of 728 patients in the DB study, 645 were enrolled in the FKB327-OLE study. The American College of Rheumatology (ACR)20 response rates for all treatment groups at Week 30 in the OLE ranged from 83.2% to 85.9%. ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76. The safety profile and incidence of antidrug antibodies were comparable across sequences.
CONCLUSION


Efficacy, safety and immunogenicity were similar among patients with RA treated with FKB327 or the RP for up to 2 years, and were not affected by single- or double-switching treatment.",2020,ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76.,"['patients with active rheumatoid arthritis (RA', 'patients with active rheumatoid arthritis', '728 patients in the DB study', 'Patients who completed the DB study were enrolled in the OLE and rerandomised 2:1 to receive', 'Patients with moderate-to-severe, active RA on a stable dose of']","['FKB327 or the RP', 'MTX', 'methotrexate (MTX', 'FKB327']","['Long-term efficacy, safety and immunogenicity', 'ACR20 response rates', 'Rheumatology (ACR)20 response rates', 'safety and immunogenicity', 'safety profile and incidence of antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",645.0,0.211765,ACR20 response rates remained stable for all patients regardless of single- or double-switching treatment and were similar for all treatment sequences through Week 76.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University Medical Center, Palo Alto, California, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kellner', 'Affiliation': 'Specialist Practice in Rheumatology and Gastroenterology, Munich, Germany.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Fujifilm Kyowa Kirin Biologics, Tokyo, Japan.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Muniz', 'Affiliation': 'Mylan Inc., Canonsburg, Pennsylvania, USA.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'University Medicine Berlin, Berlin, Germany.'}]",RMD open,['10.1136/rmdopen-2019-000987']
46,32371431,"Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naïve to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison.","OBJECTIVE


To compare improvement in pain and physical function for patients treated with baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy from randomised, methotrexate (MTX)-controlled trials in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/biologic (bDMARD)-naïve RA patients using matching-adjusted indirect comparisons (MAICs).
METHODS


Data were from Phase III trials on patients receiving monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX. Pain was assessed using a visual analogue scale (0-100 mm) and physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI). An MAIC based on treatment-arm matching, an MAIC with study-level matching and Bucher's method without matching compared change in outcomes between therapies. Matching variables included age, gender, baseline disease activity and baseline value of outcome measure.
RESULTS


With all methods, greater improvements were observed in pain and HAQ-DI at 6 months for baricitinib compared with adalimumab and tocilizumab ( p <0.05). Differences in treatment effects (TEs) favouring baricitinib for pain VAS for treatment-arm matching, study-level matching and Bucher's method, respectively, were -12, -12 and -12 for baricitinib versus adalimumab and -7, -7 and -9 for baricitinib versus tocilizumab; the difference in TEs for HAQ-DI was -0.28, -0.28 and -0.30 for adalimumab and -0.23, -0.23 and -0.26 for tocilizumab. For baricitinib versus tofacitinib, no statistically significant differences for pain improvement were observed except with one of the three methods (Bucher method) and none for HAQ-DI.
CONCLUSIONS


Results suggest greater pain reduction and improved physical function for baricitinib monotherapy compared with tocilizumab and adalimumab monotherapy. No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.",2020,No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.,"['patients treated with', 'Data were from Phase III trials on patients receiving', 'rheumatoid arthritis patients who are naïve to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs']","['monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX', 'methotrexate (MTX)-controlled', 'tocilizumab', 'baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy', 'adalimumab, tocilizumab and tofacitinib monotherapies', 'tocilizumab and adalimumab monotherapy']","['pain reduction and improved physical function', 'pain and physical function', 'physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI', 'visual analogue scale', 'Pain', 'pain and HAQ-DI', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.107884,No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fautrel', 'Affiliation': 'Sorbonne University, Pierre Louis Institute for Epidemiology and Public Health; Assistance Publique Hopitaux de Paris, Pitie-Salpetriere University Hospital, Rheumatology Dept, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Univ of Oxford, Headington, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van de Laar', 'Affiliation': 'University of Twente and Arthritis Center Twente, Enschede, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds MSK Biomed/Chapel Allerton Hosp, Leeds, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'De Leonardis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Kannowski', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nicolay', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Kadziola', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'De La Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Med Ctr, Dallas, Texas, USA.'}]",RMD open,['10.1136/rmdopen-2019-001131']
47,32310699,Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial.,,2020,,['Acute Myocardial Infarction'],"['Morphine', 'Metoclopramide']",[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]",[],,0.0699512,,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Saad', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stiermaier', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Graf', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Harald F', 'Initials': 'HF', 'LastName': 'Langer', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pöss', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Barkausen', 'Affiliation': 'Clinic for Radiology and Nuclear Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Germany (J.B.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., S.D., I.E.).'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Germany (M.S., R.M.-S., S.d.W.-T., T.S., T.G., G.F., H.F.L., T.K., J.P., I.E.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (S.D., H.T.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042816']
48,32372176,"A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102.","PURPOSE


To evaluate the efficacy of testosterone supplementation for improving aromatase inhibitor musculoskeletal symptoms (AIMSS).
METHODS


Postmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer were enrolled in this trial. Initially, patients were randomly allocated to receive either a subcutaneous testosterone pellet versus a placebo pellet. Due to slow accrual, the protocol was modified such that additional participants were randomized to receive either a topical testosterone gel or a placebo gel. Changes in patient-reported joint pain were compared between patients receiving testosterone and those receiving placebo using a two-sample t test. Changes in hot flashes and other vasomotor symptoms were also analyzed. Further analyses were conducted to evaluate whether 27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit.
RESULTS


While 64% of patients reported an improvement in joint pain at 3 months, there were no significant differences in average pain or joint stiffness at 3 or 6 months between testosterone and placebo arms. Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05). The subset of patients receiving subcutaneous testosterone also experienced improvements in hot flashes and mood swings. An inherited variant (rs7984870 CC genotype) in TNFSF11 was more likely to be associated with improvements in hot flashes in patients receiving testosterone.
CONCLUSION


The doses of testosterone supplementation used in this study did not significantly improve AIMSS.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01573442.",2020,"Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05).","['27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit', 'Postmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer', 'patients receiving testosterone', 'postmenopausal women with aromatase inhibitor-induced arthralgias']","['testosterone', 'subcutaneous testosterone pellet versus a placebo pellet', 'subcutaneous testosterone', 'topical testosterone gel or a placebo gel', 'testosterone supplementation', 'placebo']","['hot flashes', 'hot flashes and other vasomotor symptoms', 'hot flashes and mood swings', 'average pain or joint stiffness', 'joint pain', 'strength, lack of energy, urinary frequency, and stress incontinence', 'AIMSS']","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0231443', 'cui_str': 'Musculoskeletal symptom'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3219108', 'cui_str': 'Testosterone-containing product in transdermal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0231443', 'cui_str': 'Musculoskeletal symptom'}]",,0.674333,"Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cathcart-Rake', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Leon-Ferre', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Storrick', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Araba A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Terstriep', 'Affiliation': 'Sanford NCORP of the North Central Plains, Sioux Falls, SD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Glaser', 'Affiliation': 'Wright State University Boonshoft School of Medicine, Dayton, OH, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Giuliano', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mitchell', 'Affiliation': 'Southeast Clinical Oncology Research Consortium NCORP, Winston-Salem, NC, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Page', 'Affiliation': 'Wichita NCI Community Oncology Research Program, Wichita, KS, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Austin', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Deming', 'Affiliation': 'Mercy Medical Center, Des Moines, IA, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Ferreira', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lafky', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Birrell', 'Affiliation': 'The Breast and Endocrine Centre, Toorak Gardens, South Australia, Australia.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. cloprinzi@mayo.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05473-2']
49,32311001,Information feedback in relative grading: Evidence from a field experiment.,"Previous studies have revealed the role of relative performance information feedback on providing agent incentives under a relative rewarding scheme through laboratory experiments. This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment. Conducting a randomized controlled trial in a compulsory subject at a Japanese university, we show that the relative performance information feedback has a significantly positive impact on the students' examination score on average, but that the average positive impact is derived by the improvement of low-performing students.",2020,This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment.,['compulsory subject at a Japanese university'],[],[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],[],,0.0904988,This study examines the impact of relative performance information feedback of students' performance on their examination score under the relative grading scheme in an actual educational environment.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kajitani', 'Affiliation': 'Faculty of Economics, Kyoto Sangyo University, Kyoto-city, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Morimoto', 'Affiliation': 'School of Political Science and Economics, Meiji University, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Shiba', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Economics, Seikei University, Musashino-city, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0231548']
50,32379148,Comparison of the STORZ CMAC video laryngoscope to standard direct laryngoscopy in a Pierre Robin manikin. Randomised crossover trial.,,2020,,[],['STORZ CMAC video laryngoscope'],[],[],"[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]",[],,0.048548,,"[{'ForeName': 'Arnim', 'Initials': 'A', 'LastName': 'Vlatten', 'Affiliation': 'From the Department of Anesthesia, Pain Management and Perioperative Management, Dalhousie University, Halifax, Nova Scotia (AV, MC, SD) and Department of Anesthesiology and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada (AG).'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Grudzinski', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Drysdale', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001191']
51,32383985,"Correction: A comparative, single-blind, randomized study on quetiapine and aripiperazole augmentation in treatment of selective serotonin reuptake inhibitor refractory obsessive-compulsive disorder.",,2020,,[],['quetiapine and aripiperazole augmentation'],[],[],"[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.0158538,,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farhad Farid', 'Initials': 'FF', 'LastName': 'Hosseini', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghili', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Asadpour', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neema John', 'Initials': 'NJ', 'LastName': 'Mehramiz', 'Affiliation': 'The University of Arizona, College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Forouzanfar', 'Affiliation': 'Neuroscience Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Canadian journal of physiology and pharmacology,['10.1139/cjpp-2020-0207']
52,32383503,An mHealth intervention for the treatment of patients with an eating disorder: A multicenter randomized controlled trial.,"OBJECTIVE


The current multicentre randomized controlled trial assessed the clinical efficacy of a combined mHealth intervention for eating disorders (EDs) based on cognitive behavioral therapy (CBT).
METHOD


A total of 106 ED patients from eight different public and private mental health services in Spain were randomly assigned to two parallel groups. Patients of the experimental group (N = 53) received standard face-to-face CBT plus a mobile intervention through an application called ""TCApp,"" which provides self-monitoring and an online chat with the therapist. The control group (N = 53) received standard face-to-face CBT only. Patients completed self-report questionnaires on ED symptomatology, anxiety, depression, and quality of life, before and after treatment.
RESULTS


Significant reductions in primary and secondary outcomes were observed for participants of both groups, with no differences between groups. Results also suggested that the frequency with which patients attended their referral mental health institution after the intervention was lower for patients in the experimental group than for those in the control group.
DISCUSSION


The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment. Besides, the additional component offered by the TCApp does not appear to be promising from a purely therapeutic perspective but perhaps as a cost-effective tool, reducing thus the costs and time burden associated with weekly visits to health professionals.",2020,"The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment.","['patients with an eating disorder', '106 ED patients from eight different public and private mental health services in Spain']","['TCApp', 'CBT', 'combined mHealth intervention', 'standard face-to-face CBT only', 'mHealth intervention', 'standard face-to-face CBT plus a mobile intervention through an application called ""TCApp,"" which provides self-monitoring and an online chat with the therapist', 'cognitive behavioral therapy (CBT']","['referral mental health institution', 'self-report questionnaires on ED symptomatology, anxiety, depression, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}]","[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",106.0,0.0658407,"The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment.","[{'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Anastasiadou', 'Affiliation': 'Department of Information and Communication Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Brugnera', 'Affiliation': 'Department of Human and Social Sciences, University of Bergamo, Bergamo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cañas Vinader', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department, Sant Joan de Déu Hospital of Barcelona, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'SerranoTroncoso', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department, Sant Joan de Déu Hospital of Barcelona, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carretero Jardí', 'Affiliation': 'Eating Disorders Unit, ABB Center, Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Linares Bertolin', 'Affiliation': 'Eating Disorders Unit, ABB Center, Barcelona, Spain.'}, {'ForeName': 'Rudiger', 'Initials': 'R', 'LastName': 'Muñoz Rodríguez', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Martínez Nuñez', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Graell Berna', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Torralbas-Ortega', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torrent-Solà', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Puntí-Vidal', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Carrera Ferrer', 'Affiliation': 'Eating Disorders Programme IBSMIA, University Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Muñoz Domenjó', 'Affiliation': 'Department of Psychiatry, University Hospital Móstoles, Móstoles, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Diaz Marsa', 'Affiliation': 'Eating Disorders Unit, San Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Gunnard', 'Affiliation': 'Eating Disorders Unit, Quirón Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cusido', 'Affiliation': 'Board Member, HealthApp SL, Sabadell, Spain.'}, {'ForeName': 'Jordina', 'Initials': 'J', 'LastName': 'Arcal Cunillera', 'Affiliation': 'Board Member, HealthApp SL, Sabadell, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiañez-Villanueva', 'Affiliation': 'Department of Information and Communication Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",The International journal of eating disorders,['10.1002/eat.23286']
53,32381562,Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.,"BACKGROUND


The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.
METHODS


C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.
RESULTS


At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.
CONCLUSIONS


Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal.
TRIAL REGISTRATION NUMBER


NCT02505542, ClinicalTrials.gov.",2020,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","['ASDAS) <1.3 at Weeks 32/36 and 48', 'patients with early axSpA.\nMETHODS', 'patients with axial spondyloarthritis (axSpA', 'adults with early active axSpA (radiographic or non-radiographic']","['CZP 200\u2009mg every 2 weeks (Q2W', 'CZP 200\u2009mg every 4 weeks (Q4W; reduced maintenance dose) or placebo', 'CZP 200\u2009mg Q2W', 'placebo']","['remaining flare-free (flare: ASDAS', 'sustained remission (Ankylosing Spondylitis Disease Activity Score', 'sustained remission', 'flare-free']","[{'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.666024,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","[{'ForeName': 'Robert Bm', 'Initials': 'RB', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands landewe@rlandewe.nl.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Depertment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Herne, Germany.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Gaffney', 'Affiliation': 'Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Davies', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'de Peyrecave', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216839']
54,32379535,Proximal retroflexion versus second forward view of the right colon during screening colonoscopy: A multicentre randomized controlled trial.,"BACKGROUND


Colonoscopy is the gold standard investigation for the detection of colorectal cancer, but the right colon is more difficult to examine than the left colon. A second examination of the proximal colon has the potential to reduce rates of missed pathology.
OBJECTIVE


To determine whether proximal retroflexion improves the adenoma detection rate or other outcomes in the right colon compared with the forward view.
METHODS


We performed a multicentre randomized controlled trial of patients from the colorectal cancer screening programme with a positive faecal immunochemical test. Patients were randomized to a second right colon examination using proximal retroflexion or forward view.
RESULTS


A total of 692 patients were included. A second examination of the right colon, with an average additional procedure time of 1.62 min, increased the adenoma detection rate by 11%, regardless of the method used (9% proximal retroflexion  vs . 12% second forward view,  p  = 0.21). The adenoma miss rate was 19% (17% proximal retroflexion  vs . 20% forward view,  p  = 0.28) The success rate of retroflexion was 83%, without secondary complications. In the 15.6% of patients in whom lesions were detected during the second pass, endoscopic follow-up was modified by reducing the time of the next colonoscopy.
CONCLUSIONS


A second examination of the right colon, either from retroflexion or second forward view, can increase adenoma detection rate and shorten surveillance intervals in patients undergoing screening colonoscopy. This should be emphasized during colonoscopy training and integrated into diagnostic colonoscopy practice.",2020,"A second examination of the right colon, with an average additional procedure time of 1.62 min, increased the adenoma detection rate by 11%, regardless of the method used (9% proximal retroflexion  vs .","['patients from the colorectal cancer screening programme with a positive faecal immunochemical test', 'A total of 692 patients were included', 'patients undergoing screening colonoscopy']","['second right colon examination using proximal retroflexion or forward view', 'proximal retroflexion', 'Proximal retroflexion']","['adenoma miss rate', 'adenoma detection rate', 'success rate of retroflexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}]",692.0,0.0769257,"A second examination of the right colon, with an average additional procedure time of 1.62 min, increased the adenoma detection rate by 11%, regardless of the method used (9% proximal retroflexion  vs .","[{'ForeName': 'Ma Henar', 'Initials': 'MH', 'LastName': 'Núñez Rodríguez', 'Affiliation': 'Gastroenterology Department, Hospital Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Díez Redondo', 'Affiliation': 'Gastroenterology Department, Hospital Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Riu Pons', 'Affiliation': 'Department of Gastroenterology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cimavilla', 'Affiliation': 'Gastroenterology Department, Hospital Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Hernández', 'Affiliation': 'Gastroenterlogy Department, Hospital Santos Reyes, Aranda de Duero, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Loza', 'Affiliation': 'Gastroenterlogy Department, Hospital Santos Reyes, Aranda de Duero, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pérez-Miranda', 'Affiliation': 'Gastroenterology Department, Hospital Rio Hortega, Valladolid, Spain.'}]",United European gastroenterology journal,['10.1177/2050640620924210']
55,32384874,Serum level of IL-1ra was associated with the treatment of latent tuberculosis infection in a Chinese population.,"BACKGROUND


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


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


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


Our results suggested that declined serum level of IL-1ra was associated with LTBI treatment. Further studies are needed to verify whether it could be used to evaluate LTBI treatment and to predict active disease development.",2020,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","['participants who developed active TB during follow-up and age and gender matched controls stayed healthy', '21 patients diagnosed with active tuberculosis (TB) during the 2-year follow-up (12 from treated groups and 9 from untreated controls) and 42 age and gender matched healthy controls (24 from treated groups and 18 from untreated controls) were included in the study']",[],"['serum level of IL-1ra', 'levels of IL-1ra', 'Serum level of IL-1ra', 'serum IL-1ra']","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]",21.0,0.136814,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","[{'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Henan', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Zisen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Dakuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Jiaoxia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Boxuan', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Gastroenterology Department, PLA Rocket Force Characteristic Medical Center, Beijing, 100088, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China. gaolei@ipbcams.ac.cn.'}]",BMC infectious diseases,['10.1186/s12879-020-05047-x']
56,32375104,Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial.,"BACKGROUND


Adverse cardiac remodeling is a major risk factor for the development of post myocardial infarction (MI) heart failure (HF). This study investigates the effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute ST-segment-elevation myocardial infarction (STEMI).
METHODS


In this double-blind, randomized, placebo-controlled trial patients with first STEMI were eligible. To preferentially enrich patients at high risk of adverse remodeling, main inclusion criteria were a left-ventricular ejection fraction (LVEF) ≤45% and an infarct size >10% on day 5 to 9 post MI as measured by cardiac MRI. Patients were then randomized to 6 months treatment with either 25 mg fulacimstat (n = 54) or placebo (n = 53) twice daily on top of standard of care starting day 6 to 12 post MI. The changes in LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI) from baseline to 6 months were analyzed by a central blinded cardiac MRI core laboratory.
RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity. Comparable changes in LVEF (fulacimstat: 3.5% ± 5.4%, placebo: 4.0% ± 5.0%, P = .69), LVEDVI (fulacimstat: 7.3 ± 13.3 mL/m 2 , placebo: 5.1 ± 18.9 mL/m 2 , P = .54), and LVESVI (fulacimstat: 2.3 ± 11.2 mL/m 2 , placebo: 0.6 ± 14.8 mL/m 2 , P = .56) were observed in both treatment arms.
CONCLUSION


Fulacimstat was safe and well tolerated in patients with left-ventricular dysfunction (LVD) after first STEMI but had no effect on cardiac remodeling.",2020,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.",['controlled trial patients with first STEMI were eligible'],"['chymase inhibitor fulacimstat', '25 mg fulacimstat (n\u202f=\u202f54) or placebo', 'placebo']","['safe and well tolerated and achieved mean total trough concentrations', 'safe and well tolerated', 'cardiac remodeling', 'adverse cardiac remodeling', 'LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.55485,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.","[{'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine, Cardiology, Charité-Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, United States.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'Hadassah Hebrew University Hospital Ein Kerem, Heart Institute, Jerusalem, Israel.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Kettner', 'Affiliation': 'Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Shimony', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular, Bayer AG, Wuppertal, Germany. Electronic address: christiane.otto@bayer.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andres Iniguez', 'Initials': 'AI', 'LastName': 'Romo', 'Affiliation': 'Hospital Alvaro Cunqueiro, Servicio de la Cardiologia, Vigo, Spain.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Shaare Zedek Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Gonzalo Calvo', 'Initials': 'GC', 'LastName': 'Rojas', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Division of Cardiology, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.012']
57,32375239,"A Novel Exercise for Enhancing Visuospatial Ability in Older Adults with Frailty: Development, Feasibility, and Effectiveness.","We aimed to develop a novel exercise to improve visuospatial ability and evaluate its feasibility and effectiveness in older adults with frailty. A non-randomized preliminary trial was conducted between June 2014 and March 2015. We recruited 35 adults with frailty (24 women), aged 66-92 years. Participants were assigned to either locomotive- or visuospatial-exercise groups. All participants exercised under the supervision of physiotherapists for 90 min/week for 12 weeks. The visuospatial exercise participants used cubes with six colored patterns and were instructed to ""reproduce the same colored pattern as shown in the photo"", using the cubes. In the locomotive exercise group, lower extremity functional training was provided. Rates of retention and attendance measured feasibility. Most participants completed the intervention (77.3%, locomotive; 84.6%, visuospatial) and had good attendance (83.8%, locomotive; 90.7%, visuospatial). Mini-mental state examination (MMSE), clock drawing test (CDT), and seven physical performance tests were conducted before and after interventions. The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group. The cube exercise might be a feasible exercise program to potentially improve visuospatial ability and global cognition in older adults with frailty.",2020,"The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group.","['Older Adults with Frailty', 'older adults with frailty', '35 adults with frailty (24 women), aged 66-92 years', 'June 2014 and March 2015', 'participants used cubes with six colored patterns']","['novel exercise', 'locomotive exercise', 'visuospatial exercise', 'locomotive- or visuospatial-exercise groups', 'Novel Exercise', 'Mini-mental state examination (MMSE), clock drawing test (CDT']","['Rates of retention and attendance measured feasibility', 'visuospatial ability and global cognition', 'lower extremity functional training', 'visuospatial ability and evaluate its feasibility and effectiveness', 'MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments', 'good attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",35.0,0.0340268,"The improvement in the MMSE score, qualitative analysis of CDT, grip strength, and sit and reach assessments were significantly greater in the visuospatial exercise group than in the locomotive exercise group.","[{'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Nemoto', 'Affiliation': 'Dementia Medical Center, University of Tsukuba Hospital, Tsukuba 3058575, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 1730015, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Yabushita', 'Affiliation': 'Upten Health Support, Tsukuba 3050047, Japan.'}, {'ForeName': 'Keito', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'School of Health and Physical Education, University of Tsukuba, Tsukuba 3058577, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Occupational Therapy, Ibaraki Prefectural University of Health Sciences, Ami 3000394, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Occupational Therapy, Ibaraki Prefectural University of Health Sciences, Ami 3000394, Japan.'}, {'ForeName': 'Taeho', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba 3058577, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue 6900823, Japan.'}, {'ForeName': 'Tetsuaki', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba 3058575, Japan.'}, {'ForeName': 'Kiyoji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba 3058577, Japan.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5020029']
58,32383634,Effects of Kinesiotape vs Soft and Semirigid Ankle Orthoses on Balance in Patients With Chronic Ankle Instability: A Randomized Controlled Trial.,"BACKGROUND


Chronic ankle instability (CAI) is a frequent complication of ankle sprain that may be associated with long-term consequences. Although taping and bracing are common interventions that are widely used by clinicians and athletic trainers for patients with CAI, no studies have compared the effects of kinesiotaping and bracing on balance performance in these patients. The present study aimed to compare the effects of ankle kinesiotaping, a soft ankle orthosis, and a semirigid ankle orthosis on balance performance in patients with CAI.
METHODS


Sixty patients with CAI were randomly assigned to 4 groups that received kinesiotaping, a soft orthosis, a semirigid orthosis, or no treatment (control group). Dynamic and static balance were measured with the modified Star Excursion Balance Test, single leg hop test, and single leg stance test before and after a 4-week intervention period.
RESULTS


Significant between-group differences were seen in all evaluated outcomes ( P  ≤ .003). The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups. No significant differences were found among the 3 intervention groups.
CONCLUSION


Use of kinesiotaping and a soft or a semirigid ankle brace for 4 weeks were all beneficial in improving static and dynamic balance in individuals with CAI. None of the interventions was superior to the other 2.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2020,"The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups.","['individuals with CAI', 'patients with CAI', 'Patients With Chronic Ankle Instability', 'Sixty patients with CAI']","['kinesiotaping, a soft orthosis, a semirigid orthosis, or no treatment (control group', 'Kinesiotape vs Soft and Semirigid Ankle Orthoses']","['Dynamic and static balance', 'balance performance', 'static and dynamic balance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",60.0,0.0598824,"The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hadadi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Haghighat', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mohammadpour', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Sobhani', 'Affiliation': 'Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Foot & ankle international,['10.1177/1071100720917181']
59,32380894,Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD.,"BACKGROUND


Functional respiratory imaging (FRI) is a quantitative postprocessing imaging technique used to assess changes in the respiratory system. Using FRI, we characterized the effects of the long-acting muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β 2 -agonist (LABA), formoterol fumarate metered dose inhaler (FF MDI), on airway volume and resistance in patients with moderate-to-severe chronic obstructive pulmonary disease.
METHODS


Patients in this phase IIIb, randomized, double-blind crossover study received twice-daily GP MDI (18 μg) and FF MDI (9.6 μg). Primary endpoints were specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI. Secondary and other endpoints included additional FRI, spirometry, and body plethysmography parameters. Postdose efficacy assessments were performed within 60-150 min of dosing on day 15.
RESULTS


A total of 23 patients were randomized and 19 completed both treatment periods. GP MDI and FF MDI both achieved significant improvements from baseline to day 15 in siVaw [11% ( p  = 0.0187) and 23% ( p  < 0.0001) increases, respectively] and siRaw [25% ( p  = 0.0219) and 44% ( p  < 0.0001) reductions, respectively]. Although, on average, improvements were larger for FF MDI than GP MDI, some individuals displayed greater responses with each of the two treatments. These within-patient differences increased with airway generation number. Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
CONCLUSION


Both GP MDI and FF MDI significantly improved siRaw and siVaw at day 15  versus  baseline. FRI endpoints demonstrated increased sensitivity relative to spirometry and body plethysmography in detecting differences between treatments in a small number of patients. Intra-patient differences in treatment response between the LAMA and the LABA provide further support for the benefit of dual bronchodilator therapies.
CLINICALTRIALS.GOV REGISTRATION NUMBER


NCT02937584  The reviews of this paper are available via the supplemental material section.",2020,"Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
","['patients with moderate-to-severe chronic obstructive pulmonary disease', 'Patients in this phase IIIb', 'patients with COPD', '23 patients']","['muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β 2 -agonist (LABA), formoterol fumarate metered dose inhaler (FF MDI', 'Functional respiratory imaging (FRI', 'twice-daily GP MDI', 'glycopyrrolate and formoterol fumarate', 'GP MDI and FF MDI']","['specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI', 'siRaw', 'additional FRI, spirometry, and body plethysmography parameters', 'sensitivity relative to spirometry and body plethysmography', 'inspiratory capacity', 'siRaw and siVaw', 'GP MDI and FF MDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0032224', 'cui_str': 'Total body plethysmography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]",23.0,0.283185,"Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
","[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Backer', 'Affiliation': 'University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, Wilrijk, 2610 Antwerp, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Backer', 'Affiliation': 'FLUIDDA, Inc, Los Angeles, CA, USA.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verlinden', 'Affiliation': 'Formerly of FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leemans', 'Affiliation': 'Formerly of FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Van Holsbeke', 'Affiliation': 'FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mignot', 'Affiliation': 'FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Griffis', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ivanov', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fitzpatrick', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620916990']
60,32385848,"Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status Among Parents of American Indian Newborns.","OBJECTIVE


To examine the relationship between health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS) among parents of American Indian (AI) children.
METHODS


This analysis used baseline data from a randomized controlled trial that tested an oral health intervention with parents of AI newborns. Participants were recruited in parent-child dyads (N = 579). Parents completed items assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS. We examined the correlation of HL with each oral health construct, controlling for parent age and income.
RESULTS


On average, parents felt quite confident in their HL skills, performed well on questions assessing parental oral health knowledge, and endorsed beliefs likely to encourage positive parental oral health behaviors (e.g., confidence that one can successfully engage in such behaviors). Parents with more limited HL had significantly less knowledge, perceived cavities to be less severe, perceived more barriers and fewer benefits to recommended oral health behaviors, were less confident they could engage in these behaviors, and were more likely to believe their children's oral health was under the control of the dentist or a matter of chance (P values < 0.001). Limited HL was not associated with behavior (P > 0.05) but was linked to worse self-reported OHS (P = 0.040).
CONCLUSIONS


HL was associated with parental oral health knowledge, beliefs, and self-reported OHS. Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.",2020,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"['Participants were recruited in parent-child dyads (N\u2009=\u2009579', 'parents with more limited HL skills', 'with parents of AI newborns', 'Parents of American Indian Newborns', 'parents of American Indian (AI) children']",['oral health intervention'],"['sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS', 'health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS', 'Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0459279,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA. angela.brega@cuanschutz.edu.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, 205B Irvine Hall, Irvine, CA, 92697, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 East 16th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00688-4']
61,32390248,An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine.,"WHAT IS KNOWN AND OBJECTIVE


Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers.
METHODS


Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim), a validated driving simulator, on day 1 at time to maximum plasma concentration, on day 2 before the morning dose of study drug and on day 3 at steady state following the morning dose. Subjects were assessed on various driving parameters and on a computer-administered digit-symbol substitution test (CogScreen symbol digit coding test). The driving scenario is a monotonous 100 km highway route on which subjects are instructed to maintain speed and lane position.
RESULTS AND DISCUSSION


The performance of subjects who had received tolperisone was not significantly different from those who had received placebo in terms of the primary end point: standard deviation of lateral position, a measure of weaving. Subjects who had received tolperisone also performed comparably to those who had received placebo on a range of secondary measures assessing driving ability, cognition and psychomotor performance. In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability. Despite their markedly poorer driving performance after receiving cyclobenzaprine, few subjects reported feeling unsafe to drive on day 1 (10.3%) and day 2 (3.4%). The incidence of adverse events was similar for tolperisone (36.4%) and placebo (29.0%) and was greater for cyclobenzaprine (45.4%).
WHAT IS NEW AND CONCLUSION


Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).",2020,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","['Subjects who had received tolperisone also performed comparably to those who had received', 'healthy volunteers', 'Subjects']","['cyclobenzaprine', 'muscle relaxant cyclobenzaprine', 'relaxant cyclobenzaprine', 'tolperisone', 'placebo and cyclobenzaprine', 'placebo']","['safety and cognitive effects', 'driving ability and cognitive effects', 'driving ability, cognition and psychomotor performance', 'incidence of adverse events', 'standard deviation of lateral position, a measure of weaving']","[{'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0056732', 'cui_str': 'cyclobenzaprine'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0895344,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Caron', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Kaye', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wessel', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Halseth', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Drug Development, Cognitive Research Corporation, St. Petersburg, FL, USA.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13165']
62,32387408,"A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma.","INTRODUCTION


Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β 2 -agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®.
METHODS


This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. The study population was enriched for patients who were responsive to ICS therapy. The primary objective of the present study was to show non-inferiority of these doses, i.e. the low (80 μg) and high (320 μg) doses of MF delivered via Breezhaler® once daily, compared with the corresponding low (200 μg) and high (800 μg) doses of MF delivered via Twisthaler® once daily. The primary endpoint was 24 h post-dose trough forced expiratory volume in 1 s (FEV 1 ), after four weeks of treatment in patients with asthma. A secondary objective was to evaluate the efficacy of MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler® in terms of Asthma Control Questionnaire-5 (ACQ-5) after one, two, three and four weeks of treatment.
RESULTS


The LS mean difference in trough FEV 1  after four weeks of treatment between MF low dose 80 μg (Breezhaler®) and MF low dose 200 μg (Twisthaler®) was 27 mL (95% CI -34, 89); for MF high dose 320 μg (Breezhaler®) and MF high dose 800 μg (Twisthaler®) the difference was 0 mL (95% CI -60, 61). These differences were neither clinically nor statistically significant. All treatment arms provided similar clinically relevant improvements in ACQ-5 after four weeks of treatment compared with baseline. Both treatments showed a similar safety profile with a low incidence of adverse events.
CONCLUSION


The similarities in effects on lung function and ACQ after four weeks of treatment demonstrate the comparability of MF at low (80 μg) and high (320 μg) doses delivered with Breezhaler® with MF at low (200 μg) and high (800 μg) doses delivered with Twisthaler®, respectively. The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.",2020,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","['739 adolescents and adults with persistent asthma', 'patients with asthma', 'patients who were responsive to ICS therapy']","['ICS', 'MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler®', 'Mometasone furoate (MF', 'MF high dose 800 μg (Twisthaler®', 'mometasone furoate delivered via Breezhaler® or Twisthaler®']","['ACQ-5', 'efficacy and safety', '24h post-dose trough forced expiratory volume in one second (FEV 1 ', 'lung function and ACQ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",739.0,0.543909,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Demin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patalano', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hederer', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kanniess', 'Affiliation': 'Gemeinschaftspraxis Reinfeld, Reinfeld, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101919']
63,32376491,"Aeroallergen Sensitization, Serum IgE, and Eosinophilia as Predictors of Response to Omalizumab Therapy During the Fall Season Among Children with Persistent Asthma.","BACKGROUND


Perennial aeroallergen sensitization is associated with greater asthma morbidity and is required for treatment with omalizumab.
OBJECTIVE


To investigate the predictive relationship between the number of aeroallergen sensitizations, total serum IgE, and serum eosinophil count, and response to omalizumab in children and adolescents with asthma treated during the fall season.
METHODS


This analysis includes inner-city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the placebo- and omalizumab-treated groups in 2 completed randomized clinical trials, the Inner-City Anti-IgE Therapy for Asthma study and the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations study. Logistic regression modeled the relationship between greater degrees of markers of allergic inflammation and the primary outcome of fall season asthma exacerbations.
RESULTS


The analysis included 761 participants who were 62% male and 59% African American with a median age of 10 years. Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.11-1.60; P < .01), but not in the omalizumab-treated children (OR, 1.08; 95% CI, 0.91-1.28; P = .37), indicating a significant differential effect (P < .01). Likewise, there was a differential effect of omalizumab treatment in children with greater baseline total serum IgE levels (P < .01) or greater baseline serum eosinophil counts (P < .01). Multiple aeroallergen sensitization was the best predictor of response to omalizumab; treated participants sensitized to ≥4 different groups of aeroallergens had a 51% reduction in the odds of a fall exacerbation (OR, 0.49; 95% CI, 0.30-0.81; P < .01).
CONCLUSIONS


In preventing fall season asthma exacerbations, treatment with omalizumab was most beneficial in children with a greater degree of allergic inflammation.",2020,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","['city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the', '761 participants who were 62% male and 59% African American with a median age of 10 years', 'children and adolescents with asthma treated during the fall season', 'Children with Persistent Asthma']","['Inner-City Anti-IgE Therapy for Asthma (ICATA) study and the Preventative Omalizumab or Step-Up Therapy', 'omalizumab', 'placebo and omalizumab']","['baseline total serum IgE levels', 'fall season asthma exacerbations', 'Aeroallergen Sensitization, Serum IgE, and Eosinophilia', 'allergic inflammation', 'Fall asthma exacerbations', 'fall exacerbation', 'total serum IgE, and serum eosinophil count, and response to omalizumab']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]",761.0,0.144186,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: wsheehan@childrensnational.org.""}, {'ForeName': 'Rebecca Z', 'Initials': 'RZ', 'LastName': 'Krouse', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Rockville, Md.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Gill', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Gruchalla', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Gurjit K', 'Initials': 'GK', 'LastName': 'Khurana Hershey', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Kercsmar', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Carin I', 'Initials': 'CI', 'LastName': 'Lamm', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Frederic F', 'Initials': 'FF', 'LastName': 'Little', 'Affiliation': 'Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Makhija', 'Affiliation': ""Lurie Children's Hospital and Northwestern University School of Medicine, Chicago, Ill.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Searing', 'Affiliation': ""Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zoratti', 'Affiliation': 'Henry Ford Health System and Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.051']
64,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY


Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking.
METHODS


We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI.
RESULTS


From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was -2.3 CPM (95% CI -9.4, 4.8, p = 0.25, non-inferiority) and CC depth was -3.2 mm (95% CI -5.9, 0.1, p = 0.056).
CONCLUSION


In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention.
CLINICAL TRIAL REGISTRATION


URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026']
65,32388522,Photobiomodulation therapy for the management of recurrent aphthous stomatitis in children: clinical effectiveness and parental satisfaction.,"BACKGROUND


This study aims to evaluate the effectiveness of the photobiomodulation therapy (PBMT) in the treatment of minor recurrent aphthous stomatitis (MiRAS) in children, in terms of pain relief, lesion size reduction and the parental satisfaction of the therapy.
MATERIAL AND METHODS


This randomized controlled study was carried out on 60 children with clinical diagnosis of MiRAS. Patients were randomized into two groups: group A receiving laser therapy and group B receiving sham therapy (placebo). Laser therapy (diode laser, λ: 645 nm) was administered on day 1 (T0) for three consecutive days. Patients were evaluated also on day 4 (T1), on day 7 (T2) and on day 10 (T3). Oral aphthous lesions size was assessed through a periodontal probe to measure the diameter length (mm); pain was evaluated through the Visual Analogue Scale (VAS); parental satisfaction was assessed through a questionnaire.
RESULTS


The difference in the reduction of ulcers diameters between the two groups resulted statistically significant at T1 and at T2 (p<0.05). A statistically significant difference in pain reduction between two groups was found at T1 (p<0.05). No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
CONCLUSIONS


PBMT is to be considered effective in the treatment of MiRAS in children and well- accepted by the parents of the children themselves.",2020,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","['60 children with clinical diagnosis of MiRAS', 'minor recurrent aphthous stomatitis (MiRAS) in children', 'children']","['laser therapy and group B receiving sham therapy (placebo', 'Photobiomodulation therapy', 'Laser therapy (diode laser, λ: 645 nm', 'photobiomodulation therapy (PBMT']","['diameter length (mm); pain', 'pain reduction', 'reduction of ulcers diameters', 'Visual Analogue Scale (VAS); parental satisfaction', 'Oral aphthous lesions size']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",60.0,0.0304179,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': 'Dental Clinic, p.le Spedali Civili n.1 25133 Brescia elena.bardellini@unibs.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veneri', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23573']
66,32388527,"Influence of surgical ultrasound used in the detachment of flaps, osteotomy and odontosection in lower third molar surgeries. A prospective, randomized, and ""split-mouth"" clinical study.","BACKGROUND


As third molar surgery is the most commonly procedure performed in Dentistry and has been accompanied by serious postoperative disorders such as pain, edema and trismus, the study aimed to evaluate if ultrasound device would be able to reduce such postoperative features. The aim of this study was to assess the effects of soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique in mandibular third molar extractions.
MATERIAL AND METHODS


Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods. Ten patients were included in the Piezo Flap Group (PFG - the flap was elevated using piezosurgery) and ten patients were part of the Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips). The contralateral tooth was included in the Control Group (CG - conventional technique). The patients were evaluated at postoperative periods of 1, 3, 7 and 14-days. The measured parameters were duration of surgery, pain, trismus and swelling.
RESULTS


The mean duration of surgery for the PFG was 17.21 minutes (CG 10.07 minutes) and POG was 40.09 minutes (CG 15.97 minutes). There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05). There was a statistically significant difference in swelling between the PFG and POG, presenting less swelling at the 3-day postoperative period (p=0.038; p<0,05). However, for the remaining analyzed periods there was no difference (p>0.05).
CONCLUSIONS


Piezosurgery for tissue elevation of the surgical flap, osteotomy and dental sectioning in mandibular third molar extraction surgery promoted less edema in the early postoperative stages in mandibular third molar extractions despite the longer surgical duration.",2020,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"['Ten patients were included in the', 'Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods', 'mandibular third molar extractions']","['Piezo Flap Group (PFG - the flap was elevated using piezosurgery', 'surgical ultrasound', 'soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique', 'Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips']","['pain and trismus', 'duration of surgery, pain, trismus and swelling', 'mean duration of surgery for the PFG', 'swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0302269', 'cui_str': 'Excision of bone'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.0692077,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"[{'ForeName': 'L-D', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'Department of Surgery and Integrated Clinics Araçatuba School of Dentistry - UNESP Rua José Bonifácio, 1193 CEP 16015-050 São Paulo, Brazil daniela.ponzoni@unesp.br.'}, {'ForeName': 'E-N', 'Initials': 'EN', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Bonardi', 'Affiliation': ''}, {'ForeName': 'V-N', 'Initials': 'VN', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Aranega', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ponzoni', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23447']
67,31810064,High-Intensity Interval Versus Moderate-Intensity Continuous Training in Individuals With Parkinson's Disease: Hemodynamic and Functional Adaptation.,"PURPOSE


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


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


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


These results suggest that exercise intensity may influence training-induced adaptation on endothelial reactivity and aerobic capacity in individuals with Parkinson's disease.",2020,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","['Twenty participants (13 men', ""individuals with Parkinson's disease"", ""Individuals With Parkinson's Disease""]","['Moderate-Intensity Continuous Training', 'high-intensity interval training (HIIT) versus moderate-intensity continuous exercise training (MICE', 'MICE']","['Endothelial reactivity', 'Hemodynamic (resting heart rate and blood pressure, carotid femoral pulse wave velocity, endothelial reactivity, and heart rate variability) and functional variables (5-time sit-to-stand, timed up and go, and 6-min walking tests', 'hemodynamic and functional variables', 'endothelial reactivity and aerobic capacity', 'Hemodynamic and Functional Adaptation', 'High-Intensity Interval']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",20.0,0.0402688,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'Fernanda Zane', 'Initials': 'FZ', 'LastName': 'Arthuso', 'Affiliation': ''}, {'ForeName': 'Fabiana Araújo', 'Initials': 'FA', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Gabriel Felipe', 'Initials': 'GF', 'LastName': 'Moretto', 'Affiliation': ''}, {'ForeName': 'Luis Felipe Itikawa', 'Initials': 'LFI', 'LastName': 'Imaizumi', 'Affiliation': ''}, {'ForeName': 'Awassi Yophiwa', 'Initials': 'AY', 'LastName': 'Ngomane', 'Affiliation': ''}, {'ForeName': 'Guilherme Veiga', 'Initials': 'GV', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0588']
68,31810065,Acute Effects of Water-Based Concurrent Training Intrasession Exercise Sequences on Energy Expenditure in Young Women.,"BACKGROUND


To compare the acute effects of water-based aerobic-resistance and resistance-aerobic concurrent training (CT) sessions on energy expenditure (EE) during and postexercise in young women.
METHODS


Nine active women (24 [3] y; 60 [5] kg) completed 4 sessions: (1) familiarization, (2) aquatic maximal test to determine the heart rate corresponding to the anaerobic threshold, (3) CT protocol with aerobic-resistance sequence, and (4) CT protocol with resistance-aerobic sequence. Both protocols started and ended with the participants in the supine position for 30 minutes to perform resting and postexercise oxygen consumption measurements. The water-based resistance protocol comprised 4 sets of 15 seconds at maximal velocity, and the water-based aerobic protocol was performed at a continuous intensity (heart rate corresponding to the anaerobic threshold). EE measurements were calculated based on oxygen consumption and the corresponding caloric equivalent. Paired t test was used to compare the EE values between the water-based CT intrasession exercise sequences (α = .05).
RESULTS


There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
CONCLUSIONS


The intrasession exercise sequence during water-based CT had no influence on the EE in young women.",2020,"There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
","['Nine active women (24 [3', 'Young Women', 'young women']","['water-based aerobic-resistance and resistance-aerobic concurrent training (CT) sessions', '4 sessions: (1)\xa0familiarization, (2)\xa0aquatic maximal test to determine the heart rate corresponding to the anaerobic threshold, (3)\xa0CT protocol with aerobic-resistance sequence, and (4)\xa0CT protocol with resistance-aerobic sequence', 'Water-Based Concurrent Training Intrasession Exercise Sequences']","['energy expenditure (EE', 'postexercise EE', 'Energy Expenditure', 'EE values', 'water-based aerobic-resistance and resistance-aerobic in total EE']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",9.0,0.0264676,"There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
","[{'ForeName': 'Mariana R', 'Initials': 'MR', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Cristine L', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': ''}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Braga', 'Affiliation': ''}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0246']
69,31631761,Implementing a peer-support programme by group videoconferencing for isolated carers of people with dementia.,"INTRODUCTION


Carers support programmes are commonly delivered in person, limiting attendance opportunities for rural carers and others who have access barriers. Studies using technology typically use text-based forums rather than real-time technology such as videoconferencing (VC). Delivering home-based carers support programmes by VC may mitigate barriers for accessing support. We report implementation findings for delivering a telehealth peer-support programme for isolated carers of people with dementia.
METHODS


Participants were recruited through aged care providers, peak bodies and media activities. Inclusion criteria were primary dementia caregiver with Internet access and being socially or geographically isolated. The study design was a staggered randomised waitlist design. Measures included the UCLA Loneliness Scale (ULS-6) and selected scales from the e-Health Literacy Questionnaire. Recruitment activities utilised digital processes. Participants completed a six-week programme delivered by VC. Qualitative data comprised logs detailing administration and IT procedures and difficulties. Post programme, 28 participants undertook semi-structured interviews. Data were analysed using descriptive statistics and thematic analysis.
RESULTS


There were 16 groups comprising 69 participants located throughout Australia, with 87% using their own devices. Technical issues were few but included connection problems, which were compounded by low digital literacy skills. Qualitative data themes included changing perceptions in using technology, differences in communicating by VC and technical support required. Recruitment activities were time-consuming and would benefit from IT tailored for group-based work. Eight groups continued to meet on a self-organised basis.
DISCUSSION


Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.",2019,Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.,"['isolated carers of people with dementia', '28 participants undertook semi-structured interviews', 'There were 16 groups comprising 69 participants located throughout Australia, with 87% using their own devices', 'Participants were recruited through aged care providers, peak bodies and media activities', 'Inclusion criteria were primary dementia caregiver with Internet access and being socially or geographically isolated']",['telehealth peer-support programme'],['UCLA Loneliness Scale (ULS-6) and selected scales from the e-Health Literacy Questionnaire'],"[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",69.0,0.0677973,Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.,"[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Banbury', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Parkinson', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gordon', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'CQUniversity, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19873793']
70,32386000,[Effect of proprotein convertase subtilisin/kexin type 9 inhibitor on blood lipid profile in patients with extremely high risk atherosclerotic cardiovascular disease].,"OBJECTIVE


To investigate the lowering effect on lipid and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in patients with extremely high risk atherosclerotic cardiovascular disease (ASCVD).
METHODS


The outpatients and in-patients with extremely high risk ASCVD admitted to the Second Affiliated Hospital of Chongqing Medical University from April to October in 2019 were enrolled. The enrolled patients were divided into two groups by random number table method. The patients in the atorvastatin group were given only 20 mg atorvastatin orally every night for 4 weeks. In the combined group, oral atorvastatin was administered with subcutaneous injection of 140 mg evolocumab, a PCSK9 inhibitor, once every 2 weeks, and the course of treatment was 4 weeks. Serum lipid profile was measured before and 4 weeks after treatment, including triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and lipoprotein-a (Lp-a). Adverse events were recorded.
RESULTS


During the study period, a total of 40 patients were enrolled, with 20 patients in the atorvastatin group and 20 in the combined group. There was no significant difference in blood lipid profile before treatment between the two groups. After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant. Further analysis showed that the differences in TC, LDL-C and Lp-a between before and after treatment in the combined group were significantly higher than those in the atorvastatin group [TC difference (mmol/L): 2.78±1.98 vs. 0.54±0.83, LDL-C difference (mmol/L): 1.91±1.38 vs. 0.39±0.72, Lp-a difference (mg/L): 115.87±138.93 vs. -84.19±251.85, all P < 0.05]. Only 1 patient in the combined group developed allergic reaction, mainly manifested as skin rash, who alleviated after anti-allergic treatment. No other adverse reactions such as abnormal liver function and increased myozyme occurred in the two groups.
CONCLUSIONS


PCSK9 inhibitor could rapidly and effectively reduced the levels of TC, LDL-C and Lp-a in extremely high risk ASCVD patients, while had little effect on the levels of TG and HDL-C. It is safe to some extent.",2020,"After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant.","['patients with extremely high risk atherosclerotic cardiovascular disease', '40 patients were enrolled, with 20 patients in the atorvastatin group and 20 in the combined group', 'patients with extremely high risk atherosclerotic cardiovascular disease (ASCVD', 'outpatients and in-patients with extremely high risk ASCVD admitted to the Second Affiliated Hospital of Chongqing Medical University from April to October in 2019 were enrolled']","['atorvastatin', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor', 'oral atorvastatin', 'proprotein convertase subtilisin/kexin type 9 inhibitor']","['blood lipid profile', 'Adverse events', 'skin rash', 'triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and lipoprotein-a (Lp-a', 'Serum lipid profile', 'allergic reaction', 'TC, LDL-C and Lp-a', 'abnormal liver function and increased myozyme', 'levels of TC and LDL-C', 'levels of TG and HDL-C', 'levels of TC, LDL-C and Lp']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1703294', 'cui_str': 'Myozyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0184988,"After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China. Corresponding author: Du Jianlin, Email: jianlindunev@cqmu.edu.cn.'}, {'ForeName': 'Songbai', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'She', 'Affiliation': ''}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200129-00053']
71,32386001,[Clinical research of early goal directed sedation applying in acute brain injury].,"OBJECTIVE


To investigate the value and feasibility of early goal directed sedation (EGDS) in patients with acute brain injury.
METHODS


A total of 110 patients with acute brain injury who were admitted to intensive care unit (ICU) of the Third Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to March 2019 were included and randomly divided into EGDS group and standard sedation group (STD) using the random number table. Patients in the EGDS group were sedated by continuous intravenous infusion of dexmedetomidine (initial dose of 0.2 μg×kg -1 ×min -1 ) for 72 consecutive hours. Patients in the STD group received intravenous bolus of propofol as appropriate clinically. Richmond agitation-sedation score (RASS) and electroencephalogram bispectral index (BIS) were used to continuously monitor the level of sedation. All patients were given sufentanil for analgesia. Routine treatments such as dehydration and reduction of intracranial pressure with mannitol, hemostasis or antiplatelet therapy were given according to the patients' condition. Vital signs, acute physiology and chronic health evaluation II (APACHE II) score, Glasgow coma scale (GCS) score, BIS value, artery blood gas analysis, duration of mechanical ventilation, analgesic dosage and adverse events were recorded in two groups before and 24, 48, and 72 hours after sedation.
RESULTS


(1) Among the 110 patients, patients who received the second surgery due to cerebral hemorrhage, had worsening of cerebral hernia, withdrew during the course of the study, or whose family members abandoned treatment were excluded from the study. Finally, 105 patients were enrolled in the study, including 56 patients in the EGDS group and 49 in the STD group. There was no significant difference in gender, age, types of brain injury, baseline APACHE II or GCS score or rate of mechanical ventilation between the two groups. (2) Compared with before sedation, heart rate (HR) significantly decreased till 72 hours after sedation in both groups, and the decrease in the EGDS groups was more obvious as compared with the STD group (bpm: 70.49±7.53 vs. 79.83±9.48, P < 0.05). Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators. Compared with before sedation, arterial partial pressure of carbon dioxide (PaCO 2 ) was significantly increased from the 24th hour of sedation, mean artery pressure (MAP) was decreased significantly and GCS score, BIS value were increased significantly from the 48th hour of sedation, till 72 hours, which were all improved significantly as compared with the STD group [72-hour PaCO 2  (mmHg, 1 mmHg = 0.133 kPa): 40.30±5.98 vs. 31.57±8.20, 72-hour MAP (mmHg): 85.01±8.26 vs. 89.54±9.41, 72-hour GCS score: 8.62±3.34 vs. 7.89±2.74, 72-hour BIS: 60.87±24.79 vs. 56.68±33.43, all P < 0.05]. APACHE II score was significantly lower only at the 72nd hour of sedation as compared with before sedation in the EGDS group, and no significant difference was found as compared with the STD group (17.10±7.05 vs. 18.90±3.32, P > 0.05). Oxygenation index (PaO 2 /FiO 2 ) was significantly increased only at the 24th hour of sedation in the EGDS group as compared with the STD group (mmHg: 261.05±118.45 vs. 226.45±96.54, P < 0.05). (3) The duration of mechanical ventilation was significantly shorter in the EGDS group than that in the STD group (hours: 20.56±9.03 vs. 27.75±11.23, P < 0.05), and the total administered dose of sufentanil was significantly lower in the EGDS group than that in the STD group (μg: 79.16±26.76 vs. 102.46±35.48, P < 0.05). (4) Compared with the STD group, the incidence of bradycardia in the EGDS group was increased significantly [10.71% (6/56) vs. 6.12% (3/49), P < 0.05], while the incidence of tachycardia was decreased significantly [14.29% (8/56) vs. 38.78% (19/49), P < 0.05], but no significant difference was found in the incidence of hypotension [5.36% (3/56) vs. 4.08% (2/49), P > 0.05]. The incidence of unexpected extubation in the STD group was 4.08% (2/49), which did not occurre in the EGDS group.
CONCLUSIONS


EGDS can improve the GCS score and BIS value of patients with acute brain injury, suggesting that the EGDS is safe and feasible, which can help improve neurological function in patients with acute brain injury.",2020,"Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators.","['acute brain injury', '105 patients were enrolled in the study, including 56 patients in the EGDS group and 49 in the STD group', 'patients with acute brain injury', ""110 patients with acute brain injury who were admitted to intensive care unit (ICU) of the Third Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to March 2019"", '110 patients, patients who received the second surgery due to cerebral hemorrhage, had worsening of cerebral hernia, withdrew during the course of the study, or whose family members abandoned treatment were excluded from the study']","['mannitol, hemostasis or antiplatelet therapy', 'sufentanil', 'EGDS', 'early goal directed sedation (EGDS', 'EGDS group and standard sedation group (STD', 'propofol', 'dexmedetomidine']","['incidence of tachycardia', 'mean artery pressure (MAP', 'GCS score, BIS value', 'Vital signs, acute physiology and chronic health evaluation II (APACHE II) score, Glasgow coma scale (GCS) score, BIS value, artery blood gas analysis, duration of mechanical ventilation, analgesic dosage and adverse events', 'neurological function', 'heart rate (HR', 'Richmond agitation-sedation score (RASS) and electroencephalogram bispectral index (BIS', 'APACHE II and GCS scores', 'APACHE II score', 'Oxygenation index (PaO 2 /FiO 2 ', 'duration of mechanical ventilation', 'incidence of bradycardia', 'gender, age, types of brain injury, baseline APACHE II or GCS score or rate of mechanical ventilation', 'incidence of hypotension', 'GCS score and BIS value', 'arterial partial pressure of carbon dioxide (PaCO 2 ', 'incidence of unexpected extubation']","[{'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0014065', 'cui_str': 'Congenital cerebral hernia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1272694', 'cui_str': 'Abandoned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]",110.0,0.0369951,"Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators.","[{'ForeName': 'Guirong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Gengsheng', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': ""Department of Neurosurgery, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': ""Ya'nan"", 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Geriatrics, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China. Corresponding author: Yang Changchun, Email: yangchangchun99@sina.com.""}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200106-00092']
72,32389050,Necessity of Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation for Supination-External Rotation Lateral Malleolar Fractures.,"BACKGROUND


Interfragmentary lag screws, protected by a plate, have been applied for many years in the treatment of supination-external rotation (SER) ankle fractures. Recently, similar biomechanical stability was found between fixation completed with a plate and lag screw and a plate alone. The aim of this study was to determine whether interfragmentary lag screws are necessary during precontoured lateral locking plate fixation for SER lateral malleolar fractures.
METHODS


A prospective randomized controlled trial of 76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures was conducted. The patients were randomly treated either with or without the use of interfragmentary lag screws with precontoured lateral locking plate fixation. Clinical outcomes were assessed using the Olerud-Molander Ankle Score and a visual analog scale for pain. Radiologic outcomes were assessed based on the Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing. Sixty-nine patients completed 12 months of follow-up.
RESULTS


There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery. All patients in both groups achieved primary bone healing.
CONCLUSION


The results of this study suggest that with precontoured lateral locking plate fixation, the use of interfragmentary lag screw is not essential in the treatment SER lateral malleolar fractures.
LEVEL OF EVIDENCE


Level I, prospective randomized study.",2020,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"['76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures', 'Sixty-nine patients completed 12 months of follow-up', 'Supination-External Rotation Lateral Malleolar Fractures']","['precontoured lateral locking plate fixation', 'Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation', 'interfragmentary lag screws with precontoured lateral locking plate fixation']","['Radiologic outcomes', 'biomechanical stability', 'Olerud-Molander Ankle Score and a visual analog scale for pain', 'Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing', 'primary bone healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}]",76.0,0.0331161,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Gi Won', 'Initials': 'GW', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Ansan Hospital, Seoul, Korea.'}, {'ForeName': 'Hak Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}]",Foot & ankle international,['10.1177/1071100720917645']
73,32393099,Budesonide vs Saline Nasal Irrigation in Allergic Rhinitis: A Randomized Placebo-Controlled Trial.,"OBJECTIVES


Budesonide nasal irrigation is currently widely used in the treatment of chronic sinusitis typically following endoscopic sinus surgery to improve inflammatory control. Its application in treatment of allergic rhinitis has not been previously studied. This study assesses the subjective and clinical response to budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation in patients with allergic rhinitis.
STUDY DESIGN


This is a prospective, single-center, double-blind, randomized placebo-controlled trial.
SETTING


Tertiary care hospital.
SUBJECTS AND METHODS


Fifty-two patients diagnosed with allergic rhinitis were randomized into 2 groups to receive either buffered hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule. Patients were assessed at baseline and 4 weeks subjectively using the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS). Clinical assessment was done using the modified Lund-Kennedy score.
RESULTS


The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001). The budesonide irrigation group was found to have significantly better improvement than the saline nasal irrigation group with the SNOT-22 scores ( P  = .012) and VAS scores ( P  = .007). However, the difference in the clinical response between the 2 groups was not significant ( P  = .268).
CONCLUSION


This study adds evidence to the use of saline nasal irrigation in allergic rhinitis but also demonstrates efficacy of the addition of budesonide to irrigations. Budesonide nasal irrigation thus appears to be a viable treatment option for allergic rhinitis.",2020,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001).","['Allergic Rhinitis', 'Fifty-two patients diagnosed with allergic rhinitis', 'Tertiary care hospital', 'patients with allergic rhinitis']","['Placebo', 'budesonide irrigation', 'budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation', 'hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule', 'Budesonide', 'Saline Nasal Irrigation', 'saline nasal irrigation', 'Budesonide nasal irrigation', 'placebo']","['Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS', 'clinical response', 'average SNOT-22, VAS, and modified Lund-Kennedy scores', 'SNOT-22 scores', 'VAS scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.0682754,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001).","[{'ForeName': 'Nikitha', 'Initials': 'N', 'LastName': 'Periasamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Kailesh', 'Initials': 'K', 'LastName': 'Pujary', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ajay M', 'Initials': 'AM', 'LastName': 'Bhandarkar', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Naveen D', 'Initials': 'ND', 'LastName': 'Bhandarkar', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.'}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820919363']
74,32390563,"Liraglutide accelerates colonic transit in people with type 1 diabetes and polyneuropathy: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


Glucagon-like peptide-1 receptor agonists, such as liraglutide, reduce hyperglycaemia and induce weight loss and are used as a treatment in diabetes. However, common adverse effects include nausea, loss of appetite and prolonged gastric emptying. It is not known whether these changes are centrally generated or if liraglutide alters the enteric motility.
OBJECTIVE


To investigate the effects of liraglutide on gastrointestinal function and symptoms.
METHODS


A total of 48 adults with type 1 diabetes and confirmed distal symmetric polyneuropathy were randomised to receive liraglutide 1.8 mg/day or placebo for 26 weeks. Regional transit times and motility indexes were assessed with a wireless motility capsule, whereas symptoms were evaluated using the validated gastroparesis cardinal symptom index.
RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times. Liraglutide increased postprandial fullness with 29% ( p  = 0.01). Increased small bowel transit time was associated with decreased bloating ( p  = 0.008).
CONCLUSION


Liraglutide accelerates large bowel transit and decreases motility index, which may indicate better coordination of propulsive motility. This potentially improves the function of the enteric nervous system, leading to normalised colonic function and positive effects in type 1 diabetes.",2020,"RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times.","['people with type 1 diabetes and polyneuropathy', '48 adults with type 1 diabetes and confirmed distal symmetric polyneuropathy']","['placebo', 'liraglutide 1.8 mg/day or placebo', 'liraglutide', 'Liraglutide']","['gastroparesis cardinal symptom index', 'gastrointestinal function and symptoms', 'Regional transit times and motility indexes', 'motility index', 'large bowel transit time', 'nausea, loss of appetite and prolonged gastric emptying', 'colonic transit', 'gastric emptying or small-bowel transit times', 'bloating', 'postprandial fullness', 'small bowel transit time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0232688', 'cui_str': 'Large bowel transit time'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",48.0,0.196728,"RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times.","[{'ForeName': 'Anne-Marie Langmach', 'Initials': 'AL', 'LastName': 'Wegeberg', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian Stevns', 'Initials': 'CS', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Farmer', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jesper Scott', 'Initials': 'JS', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Asbjorn M', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Poul Erik', 'Initials': 'PE', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brock', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}]",United European gastroenterology journal,['10.1177/2050640620925968']
75,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES


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


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


This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010']
76,32392835,Myofunctional Trainer versus Twin Block in Developing Class II Division I Malocclusion: A Randomized Comparative Clinical Trial.,"This study aimed to evaluate and compare the dentoalveolar effects of the myofunctional trainer T4K TM  versus twin block in children with class II division I malocclusion. Two parallel arm randomized comparative clinical trial was conducted, including twenty healthy children, 9-12 years old, showing Angle's class II division I malocclusion due to mandibular retrusion. Children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow-up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were taken for measurements and comparison. T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01). The twin block showed a statistically significant reduction in the overjet (-3.75 ± 1.10 mm) ( p  < 0.0001), a significant reduction in the overbite (-16.22 ± 17.02 %) ( p  = 0.03), and a significant increase in the LAP (1.69 ± 0.70 mm) ( p  < 0.0001). The overjet showed a higher significant decrease in the twin block group than in T4K ( p  = 0.03). The mean values of the overbite were significantly decreased in twin block than in T4k ( p  < 0.0001). Both groups showed significant dentoalveolar improvements toward class I occlusion; however, the twin block showed significantly better results than T4K appliance.",2020,"T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01).","['children with class II division I malocclusion', ""twenty healthy children, 9-12 years old, showing Angle's class II division I malocclusion due to mandibular retrusion"", 'I Malocclusion']","['myofunctional trainer T4K TM  versus twin block', 'Myofunctional Trainer versus Twin Block in Developing Class II Division']","['lower arch perimeter (LAP', 'mean values of the overbite']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714535', 'cui_str': 'Malocclusion, Angle class II'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3494426', 'cui_str': 'Mandibular Retrusion'}]","[{'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C1293097', 'cui_str': 'Division'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}]",20.0,0.0771243,"T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01).","[{'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Elhamouly', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Azza A', 'Initials': 'AA', 'LastName': 'El-Housseiny', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Hanan A', 'Initials': 'HA', 'LastName': 'Ismail', 'Affiliation': 'Orthodontic Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Laila M El', 'Initials': 'LME', 'LastName': 'Habashy', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}]",Dentistry journal,['10.3390/dj8020044']
77,32394478,"Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome-A prospective, multicenter, randomized, double-blind, placebo-controlled study.","AIMS


Extracorporeal shock wave therapy (ESWT) inhibited bladder inflammation and pain in preclinical studies. We assessed ESWT for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS).
METHODS


This double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to ESWT (N = 24; 2000 shocks, frequency of 3 Hz, and maximum total energy flow density 0.25 mJ/mm 2  ) once a week for 4 weeks at suprapubic bladder area or placebo (N = 25; shock wave setting without energy transmission). The primary endpoint was the average changes in O'Leary-Sant symptom scores (OSS) between baseline and 4 weeks after treatment. Secondary endpoints included visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction.
RESULTS


At 4 weeks posttreatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. However, there were no difference in mean change between ESWT vs placebo groups. A significantly higher proportion of patients on ESWT responded as improved in the VAS ≥ 3 vs placebo (P = .035). At 12 weeks posttreatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (ESWT vs placebo; P = .011). The finding was associated with an improvement in frequency - 1.0 ± 2.3 vs 0.7 ± 3.2 (ESWT vs placebo; P = .065). No significant adverse events were found in either group.
CONCLUSIONS


A reduction in pain was discovered in this trial assessing ESWT in patients with IC/BPS but OSS, which was the primary outcome parameter, was not improved.",2020,"No significant adverse events were found in either group.
","['54 patients with IC/BPS', 'symptoms associated with interstitial cystitis/bladder pain syndrome', 'refractory interstitial cystitis/bladder pain syndrome (IC/BPS']","['extracorporeal shock wave therapy', 'Extracorporeal shock wave therapy (ESWT', 'ESWT', 'ESWT vs placebo', 'placebo']","[""average changes in O'Leary-Sant symptom scores (OSS"", 'VAS\u2009≥', 'adverse events', 'pain', 'visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction', 'OSS and VAS pain scale', 'Pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449206', 'cui_str': 'OSS'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",54.0,0.673396,"No significant adverse events were found in either group.
","[{'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Meng', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chancellor', 'Affiliation': 'Department of urology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.'}, {'ForeName': 'Hann-Chorng', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Urology, Hualien Tzu Chi General Hospital, Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualien, Taiwan.'}]",Neurourology and urodynamics,['10.1002/nau.24382']
78,32398441,"Dexmedetomidine 2 ppm Is Appropriate for the Enhancement Effect of Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Preliminary, Randomized Cross-over Study.","OBJECTIVE


Local anesthesia is essential for pain management in dentistry. The duration of anesthetic action of the addition of 5.0 and 7.5 ppm of dexmedetomidine (DEX) was significantly longer than the addition of adrenaline, and the mean duration of anesthetic action of the addition of 2.5 ppm DEX was also longer than the addition of adrenaline. We hypothesized that it is possible to safely achieve an equal local anesthesia effect as with 1:80,000 adrenaline, without using adrenaline or felypressin, by the addition of <2.5 ppm DEX to the local anesthetic solution.
MATERIALS AND METHODS


Nineteen healthy volunteers were randomly assigned by a computer to receive 1.8 mL of 1 of 3 drug combinations (1.8% lidocaine with 1.0 ppm [1.8 μg] DEX, lidocaine with 2.0 ppm [3.6 μg] DEX or lidocaine with 1:80,000 [22.5 μg] adrenaline), to produce inferior alveolar nerve block. Pulp latency and lower lip numbness (for assessing onset and duration of anesthesia) were tested, and sedation level, blood pressure, and heart rate were recorded every 2 minutes for 10 minutes, every 5 minutes from 10 to 20 minutes, and every 10 minutes from 20 to 60 minutes.
RESULTS


Pulp latency increased compared with the baseline, from 4 minutes until 60 minutes; there were no significant intergroup differences at any timepoint. Anesthesia onset did not differ between groups. Anesthesia duration did not differ between groups. Blood pressure and heart rate did not change in any group. Sedation score did not indicate deep sedation in any of the groups.
DISCUSSION


DEX at a concentration of 1.0 to 2.0 ppm enhances the local anesthetic action of lidocaine. DEX at 2.0 ppm produces similar enhancement of local anesthesia effect as the addition of 1:80,000 adrenaline.",2020,"RESULTS


Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","['Nineteen healthy volunteers', 'Inferior Alveolar Nerve Block', 'pain management in dentistry']","['DEX', 'Lidocaine', 'adrenaline or felypressin', 'Dexmedetomidine', 'lidocaine', 'DEX or lidocaine', 'DEX, lidocaine', 'adrenaline', 'lidocaine with 1.0▒ppm (1.8▒μg']","['Pulp latency', 'Anesthesia duration', 'local anesthesia effect', 'duration of anesthetic action', 'Blood pressure and heart rate', 'Sedation score', 'local anesthetic action', 'mean duration of anesthetic action', 'sedation level, blood pressure and heart rate', 'Pulp latency and lower lip numbness']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}]",19.0,0.121872,"RESULTS


Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': 'Department of Dental Anesthesiology, Field of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000839']
79,32398443,"Evaluation of the Efficacy of Prolonged Pregabalin Administration Before and After Surgery in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Randomized, Double-blind Study.","CONTEXT AND OBJECTIVE


Reconstruction of the knee ligament causes postoperative pain and delayed rehabilitation.
OBJECTIVE


The primary objective of this study was to evaluate the effect of a prolonged preoperative and postoperative pregabalin use for arthroscopic anterior cruciate ligament repair.
MATERIALS AND METHODS


Group 1 (N=25) patients received pregabalin 75 mg/d, and group 2 (N=25) received placebo, 7 days before and 7 days after surgery. Spinal anesthesia was performed using 0.5% hyperbaric bupivacaine (15 mg). The following were evaluated: pain intensity immediately after the surgery, and 12 hours, 24 hours, 1 week, 2 weeks, 1 month, and 2 months after the surgery using a Numerical Rating Scale; dose of postoperative supplementary analgesic for 2 months; time to first analgesic requirement; and side effects during 2 months. For supplementation, the participants received 1 g dipyrone; if there was no pain control, 100 mg ketoprofen was administered; if there was no effect, 100 mg tramadol was administered; and if there was no pain control, 5 mg intravenous morphine was administered until pain control.
RESULTS


There was no difference between the groups with regard to pain intensity (P=0.077). In the pregabalin group, morphine consumption was lower at 12 hours (P=0.039) and 24 hours (P=0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 hours after surgery. There was no significant difference in the incidence of nausea and vomiting. Dizziness was higher in the pregabalin group (group 1=12 patients; group 2=3 patients; P=0.005).
DISCUSSION


A prolonged preoperative and postoperative pregabalin prescription for anterior cruciate ligament repair decreased the need for supplementary analgesics during the first 24 postoperative hours but increased dizziness.",2020,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","['arthroscopic anterior cruciate ligament repair', 'Patients', 'Group 1', 'Undergoing Arthroscopic Anterior Cruciate Ligament Repair']","['morphine', 'tramadol', 'hyperbaric bupivacaine', 'pregabalin', 'Prolonged Pregabalin', 'ketoprofen', 'prolonged pre and postoperative pregabalin', 'dipyrone', 'placebo']","['dizziness', 'pain intensity', 'morphine consumption', 'nausea and vomiting, and dizziness', 'time to first analgesic requirement, and side effects']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",25.0,0.135105,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","[{'ForeName': 'Alexandro F', 'Initials': 'AF', 'LastName': 'Tobias', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP.'}, {'ForeName': 'Ed C R', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Claudio A D O', 'Initials': 'CADO', 'LastName': 'Honda', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Emanuel C', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Caio M B', 'Initials': 'CMB', 'LastName': 'de Oliveira', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Plinio D C', 'Initials': 'PDC', 'LastName': 'Leal', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Rioko K', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000841']
80,32396519,"Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.","OBJECTIVE


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


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


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


Tofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.",2020,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","['patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis', 'patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS', 'patients with inflammatory rheumatic musculoskeletal diseases', 'Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment', '3330 patients were included in this analysis']","['tofacitinib 5 or 10 mg twice daily or placebo', 'conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS', 'tofacitinib', 'placebo']","['multiple pain measures', 'pain improvements', ""Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3"", 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}]",3330.0,0.247993,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Glasgow Biomedical Research Centre, Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Rheumatology Research Group, Swedish Medical Center and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baer', 'Affiliation': 'Baer Weinberg MPC, Scarborough, Ontario, Canada.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Lukic', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA David.Gruben@pfizer.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Ming-Ann', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Maniccia', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}]",RMD open,['10.1136/rmdopen-2019-001042']
81,32333875,"Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial.","BACKGROUND


Given the unique phenotype of type 2 diabetes in Japanese patients, novel therapies such as oral semaglutide require evaluation in this population. PIONEER 9 aimed to assess the dose-response of oral semaglutide and to compare the efficacy and safety of oral semaglutide with placebo and a subcutaneous GLP-1 receptor agonist in a Japanese population.
METHODS


PIONEER 9 was a 52-week, phase 2/3a, randomised, controlled trial done at 16 sites (clinics and university hospitals) in Japan. Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out) were randomly assigned (1:1:1:1:1) to receive double-blind once-daily oral semaglutide (3 mg, 7 mg, or 14 mg) or placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg. The primary endpoint was change in HbA 1c  from baseline to week 26 with the trial product (primary) estimand (which assumes all patients remained on trial product without rescue medication use) in all randomly assigned patients. This trial is registered with ClinicalTrials.gov, NCT03018028.
FINDINGS


Between Jan 10, and July 11, 2017, 243 patients were randomly assigned to oral semaglutide 3 mg (n=49), 7 mg (n=49), or 14 mg (n=48), or placebo (n=49), or to liraglutide 0·9 mg (n=48). Changes in HbA 1c  from baseline (mean 8·2%) to week 26 were dose-dependent with oral semaglutide (mean change -1·1% [SE 0·1] for oral semaglutide 3 mg, -1·5% [0·1] for 7 mg, and -1·7% [0·1] for 14 mg), -0·1% (0·1) with placebo, and -1·4% (0·1) with liraglutide 0·9 mg. Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg. Estimated treatment differences for change in HbA 1c  compared with liraglutide 0·9 mg were 0·3 percentage points (95% CI -0·0 to 0·6; p=0·0799) for oral semaglutide 3 mg, -0·1 percentage points (-0·4 to 0·2; p=0·3942) for oral semaglutide 7 mg, and -0·3 percentage points (-0·6 to -0·0; p=0·0272) for oral semaglutide 14 mg. Gastrointestinal events, predominantly of mild or moderate severity, were the most frequently reported class of adverse event with oral semaglutide: constipation was most common, occurring in five to six (10-13%) patients with oral semaglutide, three (6%) with placebo, and nine (19%) with liraglutide 0·9 mg.
INTERPRETATION


This study showed that oral semaglutide provides significant reductions in HbA 1c  compared with placebo in a dose-dependent manner in Japanese patients with type 2 diabetes, and has a safety profile consistent with that of GLP-1 receptor agonists.
FUNDING


Novo Nordisk.",2020,"Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg.","['Japanese patients aged 20 years or older with uncontrolled type 2 diabetes managed by diet or exercise or with oral glucose-lowering drug monotherapy (washed out', 'Japanese patients with type 2 diabetes (PIONEER 9', 'Japanese patients with type 2 diabetes', 'Japanese patients', 'Between Jan 10, and July 11, 2017', '243 patients', '16 sites (clinics and university hospitals) in Japan', 'Japanese population']","['liraglutide', 'oral semaglutide monotherapy', 'placebo, or open-label subcutaneous once-daily liraglutide 0·9 mg', 'oral semaglutide with placebo', 'subcutaneous GLP-1 receptor agonist', 'liraglutide 0·9 mg', 'placebo', 'double-blind once-daily oral semaglutide', 'oral semaglutide']","['efficacy and safety', 'Gastrointestinal events', 'change in HbA 1c', 'Dose-response, efficacy, and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",243.0,0.144831,"Estimated treatment differences for change in HbA 1c  compared with placebo were -1·1 percentage points (95% CI -1·4 to -0·8; p<0·0001) for oral semaglutide 3 mg, -1·5 percentage points (-1·7 to -1·2; p<0·0001) for oral semaglutide 7 mg, and -1·7 percentage points (-2·0 to -1·4; p<0·0001) for oral semaglutide 14 mg.","[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Akita, Japan. Electronic address: yamada@gipc.akita-u.ac.jp.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Katagiri', 'Affiliation': 'Department of Metabolism and Diabetes, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nishijima', 'Affiliation': 'Novo Nordisk Pharma, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30075-9']
82,32333876,"Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.","BACKGROUND


New glucose-lowering medications need to be investigated in east Asian populations, as the clinical characteristics of type 2 diabetes differ between western and east Asian patients. The PIONEER 10 study aimed to evaluate the safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes.
METHODS


PIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan. Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication. The primary endpoint was the number of treatment-emergent adverse events over 57 weeks. Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA 1c  and bodyweight at 52 weeks. This trial is registered with ClinicalTrials.gov, NCT03015220.
FINDINGS


Between Jan 10, and May 30, 2017, 492 patients were screened and 458 were randomly assigned to oral semaglutide 3 mg (n=131), 7 mg (n=132), or 14 mg (n=130), or dulaglutide 0·75 mg (n=65). 448 (98%) patients completed the trial. Adverse events occurred in 101 (77%) of 131 patients with oral semaglutide 3 mg, 106 (80%) of 132 with oral semaglutide 7 mg, 111 (85%) of 130 with oral semaglutide 14 mg, and 53 (82%) of 65 with dulaglutide. The most common adverse events were infections and gastrointestinal events. Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide. Adverse events led to premature treatment discontinuation in four (3%) of 131 patients receiving oral semaglutide 3 mg, eight (6%) of 132 receiving oral semaglutide 7 mg, eight (6%) of 130 receiving oral semaglutide 14 mg, and two (3%) of 65 receiving dulaglutide. No deaths or severe hypoglycaemic events were reported. Based on the treatment policy estimand (ie, regardless of study drug discontinuation or rescue medication use), estimated mean reductions in HbA 1c  from baseline (8·3%) to week 52 were -0·9 percentage points (SE 0·1) with oral semaglutide 3 mg, -1·4 percentage points (0·1) with oral semaglutide 7 mg, -1·7 percentage points (0·1) with oral semaglutide 14 mg, and -1·4 percentage points (0·1) with dulaglutide (estimated treatment difference -0·3% [95% CI -0·6 to -0·1] for oral semaglutide 14 mg vs dulaglutide; p=0·0170). Estimated mean changes in bodyweight from baseline (72·1 kg) to week 52 were 0·0 kg (SE 0·3) with oral semaglutide 3 mg, -0·9 kg (0·3) with oral semaglutide 7 mg, -1·6 kg (0·3) with oral semaglutide 14 mg, and 1·0 kg (0·4) with dulaglutide (estimated treatment difference -2·6 kg [95% CI -3·5 to -1·6] for oral semaglutide 14 mg vs dulaglutide; p<0·0001).
INTERPRETATION


Oral semaglutide was well tolerated in Japanese patients with type 2 diabetes. Once-daily oral semaglutide significantly reduced HbA 1c  (14 mg dose) and bodyweight (7 mg and 14 mg doses) versus weekly subcutaneous dulaglutide 0·75 mg by week 52.
FUNDING


Novo Nordisk.",2020,Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide.,"['Japanese patients with type 2 diabetes (PIONEER 10', 'east Asian populations', 'PIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan', 'Patients aged 20 years and older with uncontrolled type 2 diabetes', 'Japanese patients with type 2 diabetes', 'western and east Asian patients', 'Between Jan 10, and May 30, 2017, 492 patients were screened and 458', '131 patients receiving', '448 (98%) patients completed the trial']","['dulaglutide 0·75 mg', 'oral semaglutide versus dulaglutide', 'subcutaneous dulaglutide', 'oral semaglutide']","['Gastrointestinal adverse events (mostly mild and transient constipation and nausea', 'number of treatment-emergent adverse events', 'Safety and efficacy', 'safety and efficacy', 'deaths or severe hypoglycaemic events', 'Adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",492.0,0.0983515,Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide.,"[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan. Electronic address: ydaisuke-kyoto@umin.ac.jp.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Gislum', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30074-7']
83,32333877,"Denosumab and cinacalcet for primary hyperparathyroidism (DENOCINA): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Medical treatment options for primary hyperparathyroidism are scarce. We aimed to assess the efficacy of denosumab and combined with cinacalcet in patients with primary hyperparathyroidism.
METHODS


In this randomised, single-centre, proof-of-concept, double-blind trial, patients aged at least 18 years with primary hyperparathyroidism were recruited from the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark. Key eligibility criteria were a T-score between -1·0 and -3·5 at the lumbar spine, femoral neck, or total hip. Patients were assigned (1:1:1) via permuted block randomisation to receive 30 mg cinacalcet per day plus 60 mg denosumab subcutaneously every 6 months (n=14; combination group) for 1 year, denosumab plus placebo (n=16; denosumab group) for 1 year, or placebo plus placebo injection (n=15; placebo group) for 1 year. Primary outcomes were changes in bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, femoral neck, and distal forearm after 1 year. Additionally, effects on bone-metabolic biochemistry were explored. Patients and investigators were masked. All enrolled patients were included in efficacy analyses. The trial was done in an outpatient setting and is registered at ClinicalTrials.gov, NCT03027557, and has been completed.
FINDINGS


Between March 14, 2017, and March 16, 2018 we recruited 285 participants. 16 patients were randomly allocated to the denosumab group, 15 to the combination group, and 15 to the placebo group. Dropout was limited to one patient in the combination group. Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]). Changes in BMD at the third distal forearm were borderline significant. Six non-fatal serious adverse events occurred (combination group [n=2], denosumab group [n=1], placebo group [n=3]). The overall prevalence of adverse events did not differ between treatment groups, and no fatal adverse events occurred.
INTERPRETATION


Evidence suggested denosumab was effective in improving BMD and lowering bone turnover in patients with primary hyperparathyroidism irrespective of cinacalcet treatment and might be a valid option for patients in which surgery is undesirable.
FUNDING


Aalborg University Hospital and Aalborg University, Denmark.",2020,"Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]).","['16 patients', 'Between March 14, 2017, and March 16, 2018', 'patients aged at least 18 years with primary hyperparathyroidism were recruited from the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark', 'patients with primary hyperparathyroidism', 'we recruited 285 participants']","['denosumab plus placebo', 'denosumab', 'denosumab and combined with cinacalcet', 'placebo', 'placebo plus placebo injection', 'Denosumab and cinacalcet']","['BMD', 'femoral neck', 'fatal adverse events', 'Changes in BMD', 'bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, femoral neck, and distal forearm after 1 year', 'overall prevalence of adverse events', 'bone-metabolic biochemistry', 'total hip', 'Six non-fatal serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",16.0,0.684571,"Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]).","[{'ForeName': 'Julius Simoni', 'Initials': 'JS', 'LastName': 'Leere', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: j.leere@rn.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Endocrinology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Robaczyk', 'Affiliation': 'Department of Endocrinology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lykkeboe', 'Affiliation': 'Department of Clinical Biochemistry, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Aase', 'Initials': 'A', 'LastName': 'Handberg', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Clinical Biochemistry, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Steinkohl', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Radiology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brøndum Frøkjær', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Radiology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Endocrinology, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Jutland, Aalborg, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30063-2']
84,32272256,"No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.","The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.",2020,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","['200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration', 'patients undergoing first isolated']","['saphenous vein grafts', 'coronary computed tomography angiography', 'nonemergent coronary artery bypass grafting (CABG', 'saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique', 'no-touch or conventional open skeletonized vein harvesting technique', 'coronary artery surgery (SWEDEGRAFT']","['patency of coronary artery bypass grafts', 'wound healing in the vein graft sites and the composite outcome of major adverse cardiac events', 'proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0398206', 'cui_str': 'Harvesting of vein'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",200.0,0.0320323,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","[{'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Ragnarsson', 'Affiliation': 'Skane University Hospital and Lund University, Lund, Sweden. Electronic address: sigurdur.ragnarsson@med.lu.se.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Janiec', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Dreifaldt', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ericsson', 'Affiliation': 'Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'University Hospital of Umea, Umea, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hultkvist', 'Affiliation': 'Linkoping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Sartipy', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ternström', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Per Vikholm', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Domingos', 'Initials': 'D', 'LastName': 'de Souza', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thelin', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.03.009']
85,32302788,Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): A cluster randomized trial of a computerized clinical decision support tool.,"BACKGROUND


Clinical decision support (CDS) tools designed to digest, filter, organize, and present health data are becoming essential in providing clinical and cost-effective care. Many are not rigorously evaluated for benefit before implementation. We assessed whether computerized CDS for primary care providers would improve atrial fibrillation (AF) management and outcomes as compared to usual care.
METHODS


Overall, 203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n = 99) or CDS (n = 104). Providers recruited 1,145 adult patients with AF to participate. The intervention was access to an evidenced-based, point-of-care computerized CDS designed to support guideline-based AF management. The primary efficacy outcome was a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year. Patients were the units of intention-to-treat analysis.
RESULTS


No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
CONCLUSIONS


IMPACT-AF rigorously assessed a CDS tool in a highly representative sample of primary care providers and their patients; however, no impact on outcomes was observed. Considering the proliferating use of CDS applications, this study highlights the need for efficacy assessments prior to adoption and clinical implementation.",2020,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","['1,145 adult patients with AF to participate', 'Atrial Fibrillation (IMPACT-AF', '203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n\u202f=\u202f99) or CDS (n\u202f=\u202f104']",['computerized CDS'],"['atrial fibrillation (AF) management and outcomes', 'composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year', 'primary efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1145.0,0.0610574,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","[{'ForeName': 'Jafna L', 'Initials': 'JL', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada; Heart and Stroke Foundation of Nova Scotia Endowed Chair in Cardiovascular Outcomes Research, Halifax, Nova Scotia, Canada. Electronic address: jafna.cox@dal.ca.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Foster', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'MacKillop', 'Affiliation': 'Sydney Primary Care Medical Clinic, Sydney, Nova Scotia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciaccia', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Shurjeel H', 'Initials': 'SH', 'LastName': 'Choudhri', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hamilton', 'Affiliation': 'QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Nemis-White', 'Affiliation': 'Strive Health Management Consulting Ltd, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Anesthesia/Pediatrics, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, Centre for Evaluation of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute (PHRI), Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.019']
86,32332564,"The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",['Transversus Abdominis Plane Block'],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.200618,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic Division of Plastic Surgery, MetroHealth Department of Plastic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
87,32289571,A picture is worth a thousand words: The effect of viewing celebrity Instagram images with disclaimer and body positive captions on women's body image.,"Research has shown that exposure to Instagram images is harmful for women's body image. Although Instagram consists of photos of both peers and celebrities, the top followed Instagram accounts are held by thin and attractive female celebrities. The present study aimed to experimentally investigate whether two forms of Instagram caption could mitigate the detrimental effect of celebrity images on women's body image. Participants were 256 female undergraduate students who were assigned to view a set of celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images. Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation. However, there was no significant effect of either form of caption. The effect of celebrity images was mediated by state appearance comparison and moderated by trait appearance comparison. It was concluded that the addition of disclaimer or body positive captions by attractive celebrities does not serve to improve women's body image.",2020,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","['Participants were 256 female undergraduate students', ""women's body image""]","['celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images']",['body dissatisfaction and decreased body appreciation'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",256.0,0.0238411,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia. Electronic address: zoe.brown@flinders.edu.au.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.03.003']
88,32395892,Resting-state and task-based centrality of dorsolateral prefrontal cortex predict resilience to 1 Hz repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is used to investigate normal brain function in healthy participants and as a treatment for brain disorders. Various subject factors can influence individual response to rTMS, including brain network properties. A previous study by our group showed that ""virtually lesioning"" the left dorsolateral prefrontal cortex (dlPFC; important for cognitive flexibility) using 1 Hz rTMS reduced performance on a set-shifting task. We aimed to determine whether this behavioural response was related to topological features of pre-TMS resting-state and task-based functional networks. 1 Hz (inhibitory) rTMS was applied to the left dlPFC in 16 healthy participants, and to the vertex in 17 participants as a control condition. Participants performed a set-shifting task during fMRI at baseline and directly after a single rTMS session 1-2 weeks later. Functional network topology measures were calculated from resting-state and task-based fMRI scans using graph theoretical analysis. The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024). Reduced repeat trial accuracy after rTMS was associated with higher baseline resting state node strength of the dlPFC (p = .017). Our results suggest that behavioural response to 1 Hz rTMS to the dlPFC is dependent on baseline functional network features. Individuals with more globally integrated stimulated regions show greater resilience to rTMS effects, while individuals with more locally well-connected regions show greater vulnerability.",2020,"The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024).","['healthy participants', '16 healthy participants, and to the vertex in 17 participants as a control condition']","['Hz (inhibitory) rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['setshifting performance', 'lower task-based betweenness centrality (BC) of the dlPFC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",16.0,0.018738,"The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024).","[{'ForeName': 'Sophie M D D', 'Initials': 'SMDD', 'LastName': 'Fitzsimmons', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Douw', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Ysbrand D', 'Initials': 'YD', 'LastName': 'van der Werf', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vriend', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}]",Human brain mapping,['10.1002/hbm.25005']
89,32398710,Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,"In the last forty years therapy outcomes for depression have remained the same with approximately 50% of patients responding to treatments. Advances are urgently required. We hypothesised that a recent treatment, metacognitive therapy (MCT), might be more effective, by targeting mental control processes that directly contribute to depression. We assessed the clinical efficacy of MCT compared to current best psychotherapy practice, CBT, in adults with major depressive disorder. A parallel randomized single-blind trial was conducted in a primary care outpatient setting. This trial is registered with the ISCRTN registry, number ISRCTN82799488. In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part. 85 were randomly allocated to MCT and 89 to CBT. Randomisation was performed independently following pre-treatment assessment and was stratified for severity of depression (low < 20 vs high > =20) on the Hamilton Depression Rating Scale (HDRS) and on sex (male/female). Assessors and trial statisticians were blind to treatment allocation. Each treatment arm consisted of up to 24 sessions of up to 60 minutes each, delivered by trained clinical psychologists. The co-primary outcome measures were assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II) at post treatment. Secondary outcomes were scores six months post treatment on these measures and a range of symptom and mechanism variables. A key trial design feature was that each treatment was implemented to maximize individual patient benefit; hence time under therapy and number of sessions delivered could vary. Treated groups in the trial were very similar on most baseline characteristics. Data were analyzed on the basis of intention to treat (ITT). No differences were found on the HDRS at post treatment or follow-up (-0.95 [-2.88 to 0.98], p = 0.336; and -1.61 [-3.65 to 0.43], p = 0.122), but floor effects on this outcome were high. However, a significant difference favouring MCT was found on the BDI-II at post treatment (-5.49 [95% CI -8.90 to -2.08], p = 0.002), which was maintained at six-month follow-up (-4.64 [-8.21 to -1.06], p = 0.011). Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-ratio=2.42 [1.20 to 4.92], p = 0.014). At follow-up the proportions were 74% compared to 56% recovery (odds-ratio=2.19 [1.05 to 4.54], p = 0.036). Significant differences favouring MCT, also maintained over time, were observed for most secondary outcomes. The results were robust against controlling for time under therapy and when outcomes were assessed at a common 90 day mid-term time-point. Limitations of the study include the use of only two therapists where one treated 69% of patients, possible allegiance effects as the study was conducted in an established CBT clinic and the chief investigator is the originator of MCT and group differences in time under therapy. Never the less evidence from this study suggests that MCT had considerable beneficial effects in treating depression that may exceed CBT.",2020,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"['In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part', 'primary care outpatient setting', 'Adults with Major Depression', 'adults with major depressive disorder']","['metacognitive therapy (MCT', 'Metacognitive Therapy versus Cognitive Behaviour Therapy', 'MCT']","['range of symptom and mechanism variables', 'MCT', 'Hamilton Depression Rating Scale (HDRS', 'assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II', 'HDRS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",174.0,0.0879843,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-64577-1']
90,32334146,Impact of viewing body image health promotion videos in adult men and women: Comparison of narrative and informational approaches.,"Body dissatisfaction is a serious public health issue, however, low awareness of its seriousness, and stigma, may inhibit treatment seeking. Social marketing videos using narrative-entertainment or documentary-informational style approaches may enhance awareness but little research has evaluated their impact, particularly potentially harmful effects. The current study addressed this gap. Men (n = 226) and women (n = 229), were randomly allocated to view one of four videos; (1) Narrative, (2) Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal. Outcome variables were assessed before and after viewing. A time-by-video interaction indicated an increase in perception of the importance of body dissatisfaction as a public health problem following informational, but not narrative videos. Time by gender interactions showed that women, but not men, experienced increased body weight satisfaction and reduced intentions to engage in body-talk after video viewing. Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison. Findings suggest that social marketing can increase awareness of body dissatisfaction without inadvertently causing harm. Results from this study provide preliminary support for dissemination through social marketing.",2020,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","['adult men and women', 'Men (n\u202f=\u202f226) and women (n\u202f=\u202f229']","['Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal', 'social marketing', 'viewing body image health promotion videos']","['body weight satisfaction and reduced intentions to engage in body-talk', 'perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison', 'awareness of body dissatisfaction', 'perception of the importance of body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0312284,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","[{'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Australia; Institute for Health and Sport, Victoria University, Melbourne, Australia. Electronic address: s.mclean@latrobe.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.04.001']
91,32335270,"The effect of acute intragastric vs. intravenous alcohol administration on inflammation markers, blood lipids and gallbladder motility in healthy men.","Ethanol intake increases plasma concentrations of triglycerides and chronic ethanol use impairs lipid metabolism and causes chronic inflammation. The gut plays an important role in metabolic handling of nutrients, including lipids, and a leaky gut associated with alcohol intake, allowing inflammatory signals to the portal vein, has been proposed to constitute a mechanism by which ethanol induces hepatic inflammation. We compared the effects of enteral and parenteral administration of ethanol on a range of circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19) as well as gallbladder volume. On two separate and randomized study days, we subjected healthy men (n = 12) to double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI). Blood was sampled and ultrasonographic evaluation of gallbladder volume was performed at frequent intervals for 4 h after initiation of ethanol administration on both days. Little or no effects were observed on plasma levels of inflammation markers during IGEI and IVEI, respectively. Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form. Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations increased more after IGEI compared to IVEI. IVEI had no effect on plasma CCK and caused an increased gallbladder volume whereas IGEI elicited a CCK response (P < 0.0001) without affecting gallbladder volume. Circulating FGF19 concentrations decreased equally in response to both ethanol administration forms. In conclusion, by evaluating a range of circulating inflammation markers during IGEI and IVEI we were not able to detect signs of systemic low-grade inflammation originating from the presence of ethanol in the gut. IVEI increased gallbladder volume whereas IGEI increased plasma CCK (with neutral effect on gallbladder volume), increased plasma VLDL cholesterol and triglyceride concentrations; indicating that the enteral route of administration may influence ethanol's effects on lipid metabolism.",2020,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","['healthy men', 'subjected healthy men (n=12) to']","['double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI', 'Ethanol intake', 'acute intragastric vs. intravenous alcohol', 'ethanol']","['Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations', 'plasma VLDL cholesterol and triglyceride concentrations', 'inflammation markers, blood lipids and gallbladder motility', 'Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol', 'lipid metabolism', 'plasma levels of inflammation markers', 'IVEI increased gallbladder volume whereas IGEI increased plasma CCK', 'gallbladder volume', 'Circulating FGF19 concentrations', 'plasma CCK', 'circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0022801', 'cui_str': 'Kupffer cell'}]",,0.130521,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","[{'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark. Electronic address: filipknop@dadlnet.dk.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2020.04.006']
92,32270483,Long-term survival and cognitive function according to blood pressure management during cardiac surgery. A follow-up.,"BACKGROUND


Cardiac surgery is associated with a risk of complications, including post-operative cognitive dysfunction (POCD). In the randomized Perfusion Pressure Cerebral Infarcts (PPCI) trial, we allocated cardiac surgery patients to either a low-target mean arterial pressure (40-50 mm Hg) or a high-target pressure (70-80 mm Hg). The study found no difference in the volume of new ischemic cerebral lesions nor POCD, but 30-day mortality tended to be higher in the high-target group. In the present study we did a long-term 3-year follow-up to assess survival and level of cognitive functioning. The primary hypothesis was that patients allocated to a high-target blood pressure had a higher long-term mortality at 3-year follow-up.
METHODS


We determined long-term mortality of patients included in the PPCI trial at 3-year follow-up using national registries and we assessed POCD using a cognitive test battery. Subjective level of functioning was assessed with questionnaires. POCD and subjective functioning at follow-up were evaluated in logistic regression models.
RESULTS


Among the 197 patients who participated in the original study, there was no significant difference in mortality over a median of 3.4 years according to blood pressure target during cardiopulmonary bypass (hazards ratio 1.23 [high vs low] 95% confidence interval: 0.50-3.02, P = .65). POCD was found in 18.9% and 14.0% in the high-target and low-target groups, respectively adjusted odds ratio 1.01 (CI 95% 0.33-3.12). No differences were found for subjective functioning between groups.
CONCLUSIONS


No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year follow-up.",2020,No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year-follow-up.,"['197 patients who participated in the original study', 'cardiac surgery patients to either a low-target mean arterial pressure (40-50 mmHg) or a high-targetpressure (70-80 mmHg']",[],"['survival and level of cognitive functioning', 'POCD', 'Blood Pressure Management', 'mortality', 'blood pressure target', 'subjective functioning', '30-day mortality', 'Subjective level of functioning', 'POCD and subjective functioning', 'volume of new ischemic cerebral lesions nor POCD', 'Long-term Survival and Cognitive Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",197.0,0.217265,No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year-follow-up.,"[{'ForeName': 'Mo H', 'Initials': 'MH', 'LastName': 'Larsen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Draegert', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Vedel', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Holmgaard', 'Affiliation': 'Department of Cardiothoracic Anaesthesia, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Anaesthesia, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13595']
93,32272255,COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.,"BACKGROUND


Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.
HYPOTHESIS


The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.
STUDY DESIGN


COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.
CONCLUSIONS


The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.",2020,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"['patients with ST elevation myocardial infarction (STEMI', 'patients with STEMI undergoing primary percutaneous coronary interventions', 'approximately 674 patients presenting with STEMI planned for primary PCI', 'patients presenting with STEMI planned for primary PCI', 'STEMI patients undergoing primary percutaneous coronary intervention (PCI']","['Prasugrel tablets', 'prasugrel crushed tablets']","['death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year', 'bleeding events', 'percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2710119', 'cui_str': 'prasugrel Oral Tablet'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]",674.0,0.146697,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"[{'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Maasstad Hospital, Rotterdam; University Medical Center Utrecht, Netherlands. Electronic address: g.vlachojannis@umcutrecht.nl.'}, {'ForeName': 'Rosanne F', 'Initials': 'RF', 'LastName': 'Vogel', 'Affiliation': 'University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Wilschut', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Miguel E', 'Initials': 'ME', 'LastName': 'Lemmert', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Academic Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'van Vliet', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'van der Waarden', 'Affiliation': 'Ambulance Zorg Rotterdam-Rijnmond, Rotterdam, Netherlands.'}, {'ForeName': 'Rutger-Jan', 'Initials': 'RJ', 'LastName': 'Nuis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paradies', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Group, Groupe Hospitalier Pitie-Salpetriere Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}]",American heart journal,['10.1016/j.ahj.2020.03.005']
94,32393496,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection.","For patients hospitalized with severe influenza A virus infection, morbidity and mortality remain high. MHAA4549A, a human monoclonal antibody targeting the influenza A virus hemagglutinin stalk, has demonstrated pharmacological activity in animal studies and in a human influenza A challenge study. We evaluated the safety and efficacy of MHAA4549A plus oseltamivir against influenza A virus infection in hospitalized patients. The CRANE trial was a phase 2b randomized, double-blind, placebo-controlled study of single intravenous (i.v.) doses of placebo, 3,600 mg MHAA4549A, or 8,400 mg MHAA4549A each combined with oral oseltamivir (+OTV) in patients hospitalized with severe influenza A virus infection. Patients, enrolled across 68 clinical sites in 18 countries, were randomized 1:1:1. The primary outcome was the median time to normalization of respiratory function, defined as the time to removal of supplemental oxygen support to maintain a stable oxygen saturation (SpO 2 ) of ≥95%. Safety, pharmacokinetics, and effects on influenza viral load were also assessed. One hundred sixty-six patients were randomized and analyzed during a preplanned interim analysis. Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV, 4.28 days; 3,600 mg MHAA4549A+OTV, 2.78 days; 8,400 mg MHAA4549A+OTV, 2.65 days), nor did it improve other secondary clinical outcomes. Adverse event frequency was balanced across cohorts. MHAA4549A+OTV did not further reduce viral load versus placebo+OTV. In hospitalized patients with influenza A virus infection, MHAA4549A did not improve clinical outcomes over OTV alone. Variability in patient removal from oxygen supplementation limited the utility of the primary endpoint. Validated endpoints are needed to assess novel treatments for severe influenza A virus infection. (This study has been registered at ClinicalTrials.gov under registration no. NCT02293863.).",2020,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","['patients hospitalized with severe influenza A. Patients, enrolled across 68 clinical sites in 18 countries', 'patients hospitalized with severe influenza A infection', 'hospitalized patients', '166 patients']","['MHAA4549A plus oseltamivir', 'placebo, 3600-mg, or 8400-mg MHAA4549A together with oral oseltamivir (+OTV', 'MHAA4549A', 'MHAA4549A+OTV', 'placebo+OTV, MHAA4549A+OTV', 'placebo']","['median time to normalization of respiratory function defined as the time to removal of supplemental oxygen support to maintain a stable SpO 2  ≥ 95', 'time to normalization of respiratory function', 'Safety, pharmacokinetics, and effects on influenza viral load', 'safety and efficacy', 'Adverse event frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C5191361', 'cui_str': '166'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",166.0,0.65193,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA lim.jeremy@gene.com.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Nimer', 'Initials': 'N', 'LastName': 'Assy', 'Affiliation': 'Galilee Medical Center, Department of Internal Med A, The Azrieli Faculty of Medicine, Nahariya, Israel.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00352-20']
95,32393551,Alterations in plasma triglycerides and ceramides: links with cardiac function in humans with type 2 diabetes.,"Cardiac dysfunction in T2D is associated with excessive FA uptake, oxidation, and generation of toxic lipid species by the heart. It is not known whether decreasing lipid delivery to the heart can effect improvement in cardiac function in humans with T2D. Thus, our objective was to test the hypothesis that lowering lipid delivery to the heart would result in evidence of decreased ""lipotoxicity,"" improved cardiac function, and salutary effects on plasma biomarkers of cardiovascular risk. Thus, we performed a double-blind randomized placebo-controlled parallel design study of the effects of 12 weeks of fenofibrate-induced lipid lowering on cardiac function, inflammation, and oxidation biomarkers, and on the ratio of two plasma ceramides, Cer d18:1 (4E) (1OH, 3OH)/24:0 and Cer d18:1 (4E) (1OH, 3OH)/16:0 (i.e., ""C24:0/C16:0""), which is associated with decreased risk of cardiac dysfunction and heart failure. Fenofibrate lowered plasma TG and cholesterol but did not improve heart systolic or diastolic function. Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation. Overall, plasma TG lowering correlated with improvement of cardiac relaxation (diastolic function) as measured by tissue Doppler-derived parameter e'. Moreover, lowering the plasma C24:0/C16:0 ceramide ratio was correlated with worse diastolic function. These findings indicate that fenofibrate treatment per se is not sufficient to effect changes in cardiac function; however, decreases in plasma TG may be linked to improved diastolic function. In contrast, decreases in plasma C24:0/C16:0 are linked with worsening cardiac function.",2020,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"['humans with type 2 diabetes', 'humans with T2D', 'type 2 diabetes (T2D']","['Fenofibrate', 'fenofibrate', 'fenofibrate-induced lipid-lowering', 'placebo']","['plasma C24:0/C16:0', 'risk of cardiac dysfunction and heart failure', 'cardiac function, inflammation and oxidation biomarkers, and on the ratio of two plasma ceramides - Cer d18:1 (4E) (1OH, 3OH)/24:0 \xa0and Cer d18:1 (4E) ', 'cardiac relaxation (diastolic function', 'plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers', 'plasma TG and cholesterol', 'Cardiac dysfunction', 'heart systolic or diastolic function', 'plasma C24:0/C16:0 ceramide ratio', 'diastolic function']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0237504', 'cui_str': 'CER'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.0435397,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110 lpeterso@wustl.edu.'}, {'ForeName': 'Xuntian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Farmer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ory', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Schaffer', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215.'}]",Journal of lipid research,['10.1194/jlr.RA120000669']
96,32335402,Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.,"BACKGROUND


Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest.
OBJECTIVES


Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up.
METHODS


In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL [""low T""] vs. ≥300 ng/dL [""normal T""]) on rates of pre-specified CV outcomes, using Cox proportional hazards models.
RESULTS


Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
CONCLUSIONS


In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke.
CONDENSED ABSTRACT


In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The ""low T"" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.",2020,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","['2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline', '2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean', 'androgen-deficient men with atherosclerotic cardiovascular disease', 'male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to']",['niacin or placebo plus simvastatin'],"['low baseline testosterone concentrations and increased risk of subsequent CV events', 'CHD death, MI, and stroke composite endpoint', 'Testosterone concentrations and risk of cardiovascular events', 'coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization', 'secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke', 'low baseline testosterone (T) concentrations and subsequent CV outcomes', 'rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007794', 'cui_str': 'Cerebral revascularisation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",2118.0,0.309705,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA. Electronic address: william.boden@va.gov.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Kashyap', 'Affiliation': 'Long Beach VA Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle, WA.'}]",American heart journal,['10.1016/j.ahj.2020.03.016']
97,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


The impact of high distraction, real-world environments on dual-task interference and flexibility of attentional prioritization during dual-task walking in people with stroke is unknown.
RESEARCH QUESTION


How does a real-world environment affect dual-task performance and flexible task prioritization during dual-task walking in adults with and without stroke?
METHODS


Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated. Single and dual-task walking were examined in two different environments (lab hallway, hospital lobby). Two different dual-task combinations were assessed (Stroop-gait, speech-gait). Each dual-task was performed first without explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction in randomized order.
RESULTS


People with stroke had significantly slower dual-task gait speed (Stroop only) in the lobby than the lab, but the effect was not clinically meaningful. Stroop reaction time for all participants was also slower in the lobby than the lab. All participants slowed their walking speed while generating spontaneous speech, but this effect was not influenced by environment. The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
SIGNIFICANCE


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
98,32397013,Comparison of Steroid Treatment with and without Hyperbaric Oxygen Therapy for Idiopathic Sudden Sensorineural Hearing Loss.,"BACKGROUND AND OBJECTIVES


In this study, we compared the outcomes of patients with idiopathic sudden sensorineural hearing loss who underwent steroid treatment with or without hyperbaric oxygen (HBO) therapy and were followed-up in our clinic.
SUBJECTS AND METHODS


Patients were divided into two groups according to their treatment regimen. Steroid group received intravenous 1 mg/kg methylprednisolone which was due to be completed in 2-3 weeks with decreasing doses, and five doses of 0.5 mL intratympanic dexamethasone. Steroid+HBO group received the same steroid treatment with the addition of HBO therapy. The audiologic results of both treatment groups were compared after considering the patients' risk factors.
RESULTS


There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss. Hearing gain was similar when evaluated by audiogram type and admission time in both treatment groups.
CONCLUSIONS


We found that the addition of HBO therapy to systemic plus intratympanic steroid treatment did not affect hearing gain at all degrees of hearing loss in this study. Furthermore, audiogram type and admission time did not affect hearing gain between the two groups.",2020,"There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss.","['Idiopathic Sudden Sensorineural Hearing Loss', 'Subjects and Methods\n\n\nPatients', 'patients with idiopathic sudden sensorineural hearing loss who underwent']","['steroid treatment with or without hyperbaric oxygen (HBO) therapy', 'dexamethasone', 'Steroid+HBO', 'Steroid Treatment with and without Hyperbaric Oxygen Therapy', 'intravenous 1 mg/kg methylprednisolone']","['audiogram type and admission time', 'Furthermore, audiogram type and admission time', 'hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss', 'Hearing gain', 'hearing gain', 'hearing loss']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0018786', 'cui_str': 'Hearing examination'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}]",,0.0292978,"There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss.","[{'ForeName': 'Abitter', 'Initials': 'A', 'LastName': 'Yücel', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Konya Health Application and Research Center, University of Health Sciences Turkey, Konya, Turkey.'}, {'ForeName': 'Yaşar', 'Initials': 'Y', 'LastName': 'Özbuğday', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Konya Training and Research Hospital, University of Health Sciences Turkey, Konya, Turkey.'}]",Journal of audiology & otology,['10.7874/jao.2019.00486']
99,32338063,"Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial.","Objective:  DBPR108, a novel dipeptidyl-peptidase-4 inhibitor, has shown great antihyperglycemic effect in animal models. This study was to evaluate the efficacy and safety of DBPR108 monotherapy in type 2 diabetes mellitus (T2DM). Methods:  This was a 12-week, double-blind, placebo-controlled phase II clinical trial. The newly diagnosed or inadequately controlled untreated T2DM patients were randomized to receive 50, 100, 200 mg DBPR108 or placebo in a ratio of 1:1:1:1. The primary efficacy outcome was HbA1c change from baseline to week 12. Relevant secondary efficacy parameters and safety were assessed. The clinical trial registration is NCT04124484. Results:  Overall, 271 of the 276 randomized patients, who received 50 mg ( n  = 68), 100 mg ( n  = 67), 200 mg ( n  = 69) DBPR108 or placebo ( n  = 67), were included in full analysis set. At week 12, HbA1c change from baseline was -0.04 ± 0.77 in placebo group, -0.51 ± 0.71, -0.75 ± 0.73, and -0.57 ± 0.78 (%,  p  < .001 vs. placebo) in 50, 100, and 200 mg DBPR108 groups, respectively. Since week 4, DBPR108 monotherapy resulted in significant improvements in secondary efficacy parameters. At end of 12-week treatment, the goal of HbA1c ≤7% was achieved in 29.85, 58.82, 55.22, and 47.83% of the patients in placebo, 50, 100, and 200 mg DBPR108 groups, respectively. The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group. Conclusions:  The study results support DBPR108 100 mg once daily as the primary dosing regimen for T2DM patients in phase III development program.",2020,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"['type 2 diabetes mellitus (T2DM', 'newly diagnosed or inadequately controlled untreated T2DM patients', 'patients with type 2 diabetes', 'T2DM patients in phase III development program']","['DBPR108 or placebo', 'placebo', 'DBPR108 monotherapy']","['secondary efficacy parameters', 'efficacy and safety', 'mild hypoglycemia', 'incidence of adverse events', 'Efficacy and safety']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0033333', 'cui_str': 'Program development'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",276.0,0.553928,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Affiliated Hospital of Beihua University, Jilin, China.'}, {'ForeName': 'Chaoli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia, China.'}, {'ForeName': 'Kuanzhi', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'The Third Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Third Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Yueyang, Hunan, China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Emergency General Hospital, Beijing, China.'}, {'ForeName': 'Zhongyuan', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Renmin Hospital of Wuhan University, Hubei, China.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Xinjiang Uiger Municipal People's Hospital, Xinjiang, China.""}, {'ForeName': 'Shuangqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Inner Mongolia Baogang Hospital, Inner Mongolia, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The second Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Anhui Provincial Hospital, Anhui, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Huashan Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Jining First People's Hospital, Shandong, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shiyan Taihe Hospital, Hubei, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Wuhan Puai Hospital, Hubei, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Support Force of Chinese PLA, Fujian, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mingbiao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}]",Current medical research and opinion,['10.1080/03007995.2020.1761311']
100,32399632,Ecological momentary assessment of temptations and lapses in non-daily smokers.,"RATIONALE


Little is known about relapse among non-daily, intermittent smokers (ITS), who have difficulty quitting, despite a lack of dependence.
OBJECTIVES


To analyze situations associated with temptations to smoke and smoking lapses among ITS trying to maintain abstinence.
METHODS


Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study. EMA data captured participants' situations and states in temptations (n = 976), including those that eventuated in lapses (n = 147), for up to 6 weeks. Randomly timed assessments assessed background states (n = 11,446). Participants also reported coping performed to prevent lapses. Multilevel analyses compared temptations to background situations, and lapse episodes to resolved temptations.
RESULTS


Temptations were marked by exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption, as well as more negative affect. Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods. Both behavioral and cognitive coping responses were associated with avoiding lapsing, but behavioral coping had much larger effects. The effects of affective distress on lapse risk were mediated by its effects on coping.
CONCLUSIONS


Smoking cues play a major role in ITS' temptations and lapses, perhaps indicating a degree of behavioral dependence. Affective distress also played a role in ITS lapses, undermining the idea that the affective distress seen in daily smokers' lapses is due to nicotine withdrawal. The data reinforce the important role of coping in preventing lapses.",2020,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","['non-daily smokers', 'Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study']",[],"['Affective distress', 'exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption', 'smoking cues and availability of cigarettes, alcohol consumption']","[{'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",130.0,0.0228674,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA. shiffman@pitt.edu.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05539-3']
101,32337491,A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients.,"Background


Previous cognitive behavioral therapies for informal caregivers (ICs) have produced negligible effects. The purpose of this study was to evaluate, in a randomized controlled trial, the efficacy of Emotion Regulation Therapy adapted for caregivers (ERT-C) on psychological and inflammatory outcomes in psychologically distressed ICs and the cancer patients cared for.
Methods


A total of 81 ICs with elevated psychological distress were randomly assigned to ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment. In 52 cases, the patient cared for by the IC was included. Patients did not receive ERT-C. Both the ERT-C and waitlist groups were followed 3 and 6 months post-treatment. Data were analyzed with multilevel models, and  P  values were two-sided.
Results


Compared with ICs in the waitlist condition, ICs in the ERT-C condition experienced medium to large statistically significant reductions in psychological distress (Hedge's  g  =   0.86, 95% confidence interval [CI] = 0.40 to 1.32,  P <  .001), worry ( g  =   0.96, 95% CI = 0.50 to 1.42,  P <  .001), and caregiver burden ( g  =   0.53, 95% CI = 0.10 to 1.99,  P  = .007) post-treatment. No statistically significant effects were found for rumination ( g  =   0.24, 95% CI = -0.20 to 0.68,  P  = .220). Results concerning caregiver burden were maintained through 6 months follow-up. Although the effects on psychological distress and worry diminished, their end-point effects remained medium to large. No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI = -0.27 to 0.61,  P  = .570; interleukin-6:  g  = .35, 95% CI = -0.09 to 0.79,  P  = .205; tumor necrosis factor-alpha:  g  = .11, 95% CI = -0.33 to 0.55,  P  = .686). Patients whose ICs attended ERT-C experienced a large increase in quality of life post-treatment ( g  =   0.88, 95% CI = 0.18 to 1.58,  P  = .017).
Conclusions


To our knowledge, this is the first randomized controlled trial evaluating the efficacy of ERT-C for ICs. Given the previous disappointing effects of other cognitive behavioral therapies for this population, the present findings are very encouraging. Identifying ICs with elevated psychological distress and providing them with relevant psychotherapy appears an important element of comprehensive cancer care.",2020,"No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI","['A total of 81 ICs with elevated psychological distress', 'informal caregivers (ICs', 'psychologically distressed ICs and the cancer patients cared for', 'Psychologically Distressed Caregivers of Cancer Patients']","['Emotion Regulation Therapy', 'ERT-C', 'ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment', 'Emotion Regulation Therapy adapted for caregivers (ERT-C']","['rumination', 'caregiver burden', 'systemic inflammation', 'quality of life post-treatment', 'psychological distress']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",81.0,0.194614,"No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI","[{'ForeName': 'Mia S', 'Initials': 'MS', 'LastName': ""O'Toole"", 'Affiliation': 'Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital, Denmark.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Mennin', 'Affiliation': 'Department of Psychology, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Applebaum', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Rose', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital, Denmark.'}]",JNCI cancer spectrum,['10.1093/jncics/pkz074']
102,32239659,Safety of dapagliflozin in a broad population of patients with type 2 diabetes: Analyses from the DECLARE-TIMI 58 study.,"AIMS


To evaluate comprehensively the safety of dapagliflozin in patients with type 2 diabetes (T2DM), with emphasis placed on potential safety concerns related to the sodium-glucose co-transporter-2 inhibitor class.
METHODS


In the Dapagliflozin Effect on Cardiovascular Events - Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) study, 17 160 patients with T2DM were randomized to dapagliflozin or placebo and followed for a median of 4.2 years. Safety was evaluated in 17 143 patients receiving at least one dose of study drug.
RESULTS


Acute kidney injury occurred less frequently with dapagliflozin, and adverse events suggestive of volume depletion were balanced between treatment groups, both irrespective of baseline estimated glomerular filtration rate, blood pressure, diuretic or loop diuretic use (interaction P values >0.05). Fractures and malignancies were balanced between the groups, irrespective of sex, diabetes duration or smoking (interaction P values >0.05) and fewer cases of bladder cancer occurred in the dapagliflozin versus the placebo group. Diabetic ketoacidosis was very rare, but more frequent with dapagliflozin versus placebo (27 vs. 12 patients with events; P = 0.02), yet signs, symptoms and contributing factors were similar in the two groups. Major hypoglycaemia occurred less frequently with dapagliflozin versus placebo, regardless of baseline use of either insulin or sulphonylureas (interaction P values >0.05). There were more adverse events of genital infections leading to discontinuation of study drug in the dapagliflozin versus the placebo group, but serious genital infections were few and balanced between treatment groups. Urinary tract infections, acute pyelonephritis and urosepsis were also balanced between treatment groups.
CONCLUSIONS


Dapagliflozin was well tolerated. The long duration and large number of patient-years in DECLARE-TIMI 58 comprehensively addressed previous safety questions, confirming the robust safety profile of dapagliflozin.",2020,"Fractures and malignancies were balanced irrespective of sex, diabetes duration or smoking (interaction p-values >0.05) and fewer cases of bladder cancer occurred in the dapagliflozin vs. placebo group.","['17,143 patients receiving at least one dose of study drug', 'patients with type 2 diabetes (T2DM', '17,160 patients with T2DM', 'patients with type 2 diabetes - analyses from the DECLARE - TIMI 58 study']","['dapagliflozin vs. placebo', 'Dapagliflozin', 'dapagliflozin or placebo', 'dapagliflozin']","['tolerated', 'blood pressure, diuretic or loop diuretic use', 'Safety', 'adverse events of genital infections', 'bladder cancer', 'Urinary tract infections, acute pyelonephritis and urosepsis', 'Major hypoglycemia', 'dapagliflozin, and adverse events suggestive of volume depletion', 'Diabetic ketoacidosis (DKA', 'serious genital infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",17160.0,0.0513308,"Fractures and malignancies were balanced irrespective of sex, diabetes duration or smoking (interaction p-values >0.05) and fewer cases of bladder cancer occurred in the dapagliflozin vs. placebo group.","[{'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, Faculty of Health and Life Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Centre, Dallas, Texas.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Gyorgy', 'Initials': 'G', 'LastName': 'Jermendy', 'Affiliation': '3rd Medical Department, Bajcsy-Zsilinszky Teaching Hospital, Budapest, Hungary.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Hadjadj', 'Affiliation': ""L'institut du thorax, INSERM, CNRS, UNIV Nantes, CHU Nantes, Department of Endocrinology, Diabetes and Nutrition, Nantes, France.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14041']
103,32332545,Computer-Aided Design and Manufacturing Cutting and Drilling Guides with Prebent Titanium Plates Improve Surgical Accuracy of Skeletal Class III Malocclusion.,"BACKGROUND


The aim of this study was to evaluate the effects of the use of computer-aided design and manufacturing cutting and drilling guides with prebent titanium plates for the correction of skeletal class III malocclusion.
METHODS


In this prospective, randomized, controlled clinical trial, 46 patients with skeletal class III malocclusion were randomly assigned into two groups. The patients underwent bimaxillary surgery with computer-aided design and manufacturing cutting and drilling guides with prebent titanium plates (experimental group) or computer-aided design and manufacturing splints (control group). Preoperative and postoperative imaging data were collected and then analyzed using Mimics Research 19.0, Geomagic Studio, and IBM SPSS Version 21.0.
RESULTS


Deformity evaluation and posttreatment assessment were performed for all patients. The experimental group had fewer postoperative complications. Comparison of the linear and angular differences to facial reference planes revealed more accurate repositioning of the mandible and condyles in the experimental group, although the position of several landmarks still requires small adjustments.
CONCLUSION


Computer-aided design and manufacturing cutting and drilling guides with prebent titanium plates effectively corrected skeletal class III malocclusion, providing positional control of segments with reasonable surgical accuracy.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,The experimental group had fewer postoperative complications.,['46 patients with skeletal class III malocclusion'],"['Computer-Aided Design and Manufacturing Cutting and Drilling Guides with Prebent Titanium Plates', 'computer-aided design and manufacturing cutting and drilling guides with prebent titanium plates', 'bimaxillary surgery with computer-aided design and manufacturing cutting and drilling guides with prebent titanium plates (experimental group) or computer-aided design and manufacturing splints (control group']",['postoperative complications'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0399526', 'cui_str': 'Malocclusion, Angle class III'}]","[{'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",46.0,0.0218564,The experimental group had fewer postoperative complications.,"[{'ForeName': 'Kehan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Chengdu and Shanghai, People's Republic of China From the Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University; and the Department of Oral and Maxillofacial Surgery, Shanghai Stomatological Hospital, Fudan University.""}, {'ForeName': 'Jiayang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Chunwei', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Luo', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006794']
104,32332565,"Reply: The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.187489,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery Department of Anesthesiology Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, Mo.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': ''}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
105,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.
METHODS


We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.
RESULTS


A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.
CONCLUSIONS


In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282']
106,32193169,Visual and cognitive processing of thin-ideal Instagram images containing idealized or disclaimer comments.,"Recent studies have demonstrated that exposure to thin-ideal social media content is associated with decreased body satisfaction, and disclaimer comments have been a proposed intervention. This experiment uses eye-tracking methods to explore the effect of disclaimer comments on participants' processing of thin-ideal Instagram images. Women ages 18-35 (N = 181) were randomly assigned to view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic. Participants' eye movements were tracked during viewing. Following exposure, participants reported their anxiety about specific body regions, as well as their perceptions of social pressure for thinness. Post-test body anxiety and perceived pressure for thinness did not differ based on experimental condition. Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition. Attention to the model's thighs was associated with increased body anxiety about the thighs in both conditions, whereas attention to the model's waist was associated with increased body anxiety about the waist only in the Idealized Comment condition. This indicates that the disclaimer comments were somewhat, but not entirely, effective.",2020,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","['Women ages 18-35 (N = 181', ""participants' processing of thin-ideal Instagram images""]","['view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic']","['Visual and cognitive processing', 'body anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0010341', 'cui_str': 'Critique'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",181.0,0.0172846,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","[{'ForeName': 'Amelia C', 'Initials': 'AC', 'LastName': 'Couture Bue', 'Affiliation': 'Communication Studies, University of Michigan, United States. Electronic address: ameliacc@umich.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Communication Studies, University of Michigan, United States.'}]",Body image,['10.1016/j.bodyim.2020.02.014']
107,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND


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


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


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


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


UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9  viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10  viral particles, and the high-dose group received 5\u2008×\u200810 10  viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay.
","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2']
108,31529159,How adverse events and permanent medication stoppages affect changes in patients' beliefs about oral antineoplastic agents.,"BACKGROUND


Patients with advanced cancer often experience adverse events related to oral antineoplastic agents (OAAs) and permanent OAA medication stoppages, yet it is unknown how these factors impact medication beliefs. Such beliefs about OAA therapy may lend insight into decisions about continued cancer treatment near the end of life.
PURPOSE


To explore relationships that adverse events and permanent OAA stoppages have on medication beliefs during the first 12 weeks following new OAA initiation.
DESIGN


A secondary data analysis from a National Cancer Institute-funded randomized controlled trial testing an intervention to promote symptom management and OAA adherence.
SETTING/SUBJECTS


Patients ≥ 21 years of age initiating a new course of OAA medication were recruited from six United States Comprehensive Cancer Centers. This analysis was based on a subset of patients with advanced disease (N = 60).
MEASUREMENTS


Beliefs about Medicine Questionnaire, Common Terminology Criteria for Adverse Events, and medical records of permanent OAA stoppages.
RESULTS


Significant decline in beliefs regarding the necessity of OAA medications existed between patients experiencing three or more adverse events and those experiencing a permanent OAA stoppage.
CONCLUSIONS


Beliefs about the necessity of OAA medication change when physicians stop OAA medication or the patient experiences three or more adverse events. Concern regarding OAA medication did not change in response to medication stoppage or adverse events for this sample. Perhaps, patients with advanced cancers may be more accepting of adverse events that occur along the treatment trajectory and are not concerned about OAA medication once it is stopped. Findings suggest the importance of physicians' discussions of adverse events and decisions to permanently stop OAA medication as a means of transitioning to a new phase of cancer care that may include palliative or hospice considerations, given that beliefs about medication necessity are changing during these threats to cancer treatment.",2020,Concern regarding OAA medication did not change in response to medication stoppage or adverse events for this sample.,"['patients with advanced disease (N\u2009=\u200960', '21\xa0years of age initiating a new course of OAA medication were recruited from six United States Comprehensive Cancer Centers', 'Patients ≥', 'Patients with advanced cancer', 'patients with advanced cancers']",[],"['Beliefs about Medicine Questionnaire, Common Terminology Criteria for Adverse Events, and medical records of permanent OAA stoppages', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1516728', 'cui_str': 'CTCAE (Common Terminology Criteria for Adverse Events)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.02405,Concern regarding OAA medication did not change in response to medication stoppage or adverse events for this sample.,"[{'ForeName': 'Victoria K', 'Initials': 'VK', 'LastName': 'Marshall', 'Affiliation': 'College of Nursing, University of South Florida, 12901 Bruce B. Downs Blvd., MDC 22, Tampa, FL, 33612, USA. vkmarshall@health.usf.edu.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'College of Medicine, Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Lehto', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05073-9']
109,31658051,Erythrocyte deformability and aggregability in patients undergoing colon cancer surgery and effects of two infusions with omega-3 fatty acids.,"BACKGROUND


An adequate erythrocyte function is vital for tissue oxygenation and wound healing. The erythrocyte membrane phospholipid composition plays an important role in erythrocyte function and administration of omega-3 fatty acids may provide a means to improve it.
OBJECTIVE


To investigate peri-operative erythrocyte function and effects of omega-3 fatty acidsMETHODS:Forty-four patients undergoing elective laparoscopic colon resection for non-metastasized cancer were randomized between intravenous omega-3 poly-unsaturated fatty acids (n-3 PUFAs) or placebo (saline). Peri-operative blood samples were analyzed with a Lorrca MaxSIS Ektacytometer and erythrocyte membrane phospholipids were determined with gas chromatography.
RESULTS


Patient and operation characteristics were equal between groups. There was a significant increase in erythrocyte membrane eicosapentaenoic acid (EPA) but not docosahexaenoic acid (DHA) in the n-PUFA group. There were no significant differences in erythrocyte deformability but the aggregation index (AI) was significantly lower and the aggregation half time (T½) was significantly higher in the n-3 PUFA group.
CONCLUSION


This study confirms rapid changes in erythrocyte membrane phospholipid composition after administration of intravenous n-3 PUFAs. Erythrocyte deformability parameters were not affected but erythrocyte aggregability was decreased in the n-3 PUFA group. Further investigation is necessary to gain more insights in the effects of n-3 PUFA and the postoperative inflammatory response on erythrocyte function.",2020,"There were no significant differences in erythrocyte deformability but the aggregation index (AI) was significantly lower and the aggregation half time (T½) was significantly higher in the n-3 PUFA group.
","['patients undergoing colon cancer surgery', 'four patients undergoing elective laparoscopic colon resection for non-metastasized cancer']","['n-3 PUFA', 'intravenous omega-3 poly-unsaturated fatty acids (n-3 PUFAs) or placebo (saline', 'intravenous n-3 PUFAs', 'omega-3 fatty acids', 'omega-3 fatty acidsMETHODS:Forty']","['erythrocyte aggregability', 'erythrocyte deformability but the aggregation index (AI', 'Erythrocyte deformability parameters', 'Erythrocyte deformability and aggregability', 'erythrocyte membrane eicosapentaenoic acid (EPA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte Filterability'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]",,0.0374405,"There were no significant differences in erythrocyte deformability but the aggregation index (AI) was significantly lower and the aggregation half time (T½) was significantly higher in the n-3 PUFA group.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bakker', 'Affiliation': 'Northwest Clinics Alkmaar, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Northwest Clinics Alkmaar, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Stoutjesdijk', 'Affiliation': 'University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Houdijk', 'Affiliation': 'Northwest Clinics Alkmaar, The Netherlands.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190687']
110,31810763,Improving physicians' surgical ward round competence through simulation-based training.,"OBJECTIVE


Ward rounds are an essential part of physicians' daily routine. Existing studies suggest that their practical implementation is inconsistent. Therefore, developing interventions to train ward round competence and assessing if they are effective educational tools are crucial goals for research.
METHODS


We analysed a simulation-based tutorial dedicated to fourth-year medical students, including casework and ward round simulation. We investigated the effectiveness of this intervention regarding ward round competence through a randomized controlled trial. Performance was assessed with the modified/validated surgical ward round assessment tool by two blinded and trained raters. Supplementary, motivation during the ward round tutorial was assessed for all students at different time points.
RESULTS


Analysis of the ratings show that, in contrast to the control group (pre: 66.1 vs. post: 64.8 points, p =  0.72), the ward round competence of the intervention group (pre: 62.6 vs. post: 69.6 points, p =  0.0169) improved significantly after participating in the ward round tutorial.
CONCLUSION


The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
PRACTICE IMPLICATIONS


Participation in ward round trainings is a valuable tool to prepare students for their future professional practise.",2020,"The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
",[],[],[],[],[],[],,0.0293577,"The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Grünewald', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: m.gruenewald@tum.de.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany; Department of Obstetrics and Gynecology, University Hospital rechts der Isar, Technical University of Munich, Ismaningerstrasse 22, 81675 Munich, Germany. Electronic address: evelyn.klein@tum.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, Institute of Medical Informatics, Statistics and Epidemiology, Ismaninger Str. 22, 81675 Munich, Germany. Electronic address: alexander.hapfelmeier@tum.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wuensch', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany; Clinic of Psychosomatic Medicine and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5a, 79104 Freiburg, Germany. Electronic address: alexander.wuensch@uniklinik-freiburg.de.'}, {'ForeName': 'Pascal O', 'Initials': 'PO', 'LastName': 'Berberat', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: berberat@tum.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartmeier', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: martin.gartmeier@tum.de.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.029']
111,32151992,#Loveyourbody: The effect of body positive Instagram captions on women's body image.,"One increasing trend on social media is the posting of body positive content that aims to challenge narrow beauty ideals and instead promote acceptance and appreciation of all bodies. The aim of the present study was to experimentally investigate the effect of body positive captions attached to Instagram images on young women's body image. Participants were 384 women aged 18-30 years randomly assigned to view Instagram images of thin or average-sized women containing either body positive captions or no captions. In contrast to prediction, the body positive captions had no effect on body dissatisfaction or body appreciation. There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images. A significant three-way interaction indicated that for women high on thin-ideal internalisation, body positive captions on average images led to greater body appreciation, but lower body appreciation when attached to thin images. The results suggest that the visual imagery of an Instagram post is a more potent contributor to body image than any accompanying text. Presenting a more diverse array of women's bodies on social media is likely a more effective way to foster body satisfaction and appreciation.",2020,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","['Participants were 384 women aged 18-30 years randomly assigned to', ""young women's body image"", ""women's body image""]","['body positive captions attached to Instagram images', 'Loveyourbody', 'view Instagram images of thin or average-sized women containing either body positive captions or no captions', 'body positive Instagram captions']","['body dissatisfaction and greater body appreciation', 'body dissatisfaction or body appreciation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",384.0,0.0408839,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Anderberg', 'Affiliation': 'Flinders University, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.015']
112,32086189,A cluster randomized controlled trial of the SoMe social media literacy body image and wellbeing program for adolescent boys and girls: Study protocol.,"Youth spend substantial time on social media, which can foster self-critical processes that increase risk of body dissatisfaction, disordered eating, and depressed mood. To date, there have been few investigations of interventions to decrease the negative impacts of social media engagement in adolescent boys and girls. This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles. The RCT will be conducted with grades 7-8 students from Australian secondary schools. Using block randomization, grade levels within schools will be assigned to either the SoMe program (intervention) or health lessons as usual (control). Primary outcomes will be body satisfaction, dietary restraint, and strategies to increase muscles. Secondary outcomes will be self-esteem and depressed mood. Participants will complete assessments on four occasions - baseline, five-weeks post-baseline, and six- and 12-month post-baseline. Analyses will compare outcomes in the intervention compared to the control group. This study will be the first to implement a RCT design to evaluate the impact of a school-based social media literacy program designed to mitigate negative impacts of social media.",2020,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","['grades 7-8 students from Australian secondary schools', 'adolescent boys and girls']","['SoMe program (intervention) or health lessons as usual (control', 'SoMe social media literacy body image and wellbeing program']","['body satisfaction, dietary restraint, and strategies to increase muscles', 'self-esteem and depressed mood']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",,0.0798022,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","[{'ForeName': 'Chloe S', 'Initials': 'CS', 'LastName': 'Gordon', 'Affiliation': 'La Trobe University, Victoria, Australia. Electronic address: c.gordon@latrobe.edu.au.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'Northeastern University, Boston, MA, USA; Department of Psychiatric Emergency & Acute Care, Lapeyronie Hospital, CHRU, Montpellier, France.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of West of England, Bristol, England, United Kingdom.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'La Trobe University, Victoria, Australia; Victoria University, Australia.'}, {'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Victoria, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Paxton', 'Affiliation': 'La Trobe University, Victoria, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.003']
113,31981516,"Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial.","BACKGROUND


Neurodegeneration is the pathological substrate that causes major disability in secondary progressive multiple sclerosis. A synthesis of preclinical and clinical research identified three neuroprotective drugs acting on different axonal pathobiologies. We aimed to test the efficacy of these drugs in an efficient manner with respect to time, cost, and patient resource.
METHODS


We did a phase 2b, multiarm, parallel group, double-blind, randomised placebo-controlled trial at 13 clinical neuroscience centres in the UK. We recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5. Participants were randomly assigned (1:1:1:1) at baseline, by a research nurse using a centralised web-based service, to receive twice-daily oral treatment of either amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo for 96 weeks. The randomisation procedure included minimisation based on sex, age, EDSS score at randomisation, and trial site. Capsules were identical in appearance to achieve masking. Patients, investigators, and MRI readers were unaware of treatment allocation. The primary outcome measure was volumetric MRI percentage brain volume change (PBVC) from baseline to 96 weeks, analysed using multiple regression, adjusting for baseline normalised brain volume and minimisation criteria. The primary analysis was a complete-case analysis based on the intention-to-treat population (all patients with data at week 96). This trial is registered with ClinicalTrials.gov, NCT01910259.
FINDINGS


Between Jan 29, 2015, and June 22, 2016, 445 patients were randomly allocated amiloride (n=111), fluoxetine (n=111), riluzole (n=111), or placebo (n=112). The primary analysis included 393 patients who were allocated amiloride (n=99), fluoxetine (n=96), riluzole (n=99), and placebo (n=99). No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]). No emergent safety issues were reported. The incidence of serious adverse events was low and similar across study groups (ten [9%] patients in the amiloride group, seven [6%] in the fluoxetine group, 12 [11%] in the riluzole group, and 13 [12%] in the placebo group). The most common serious adverse events were infections and infestations. Three patients died during the study, from causes judged unrelated to active treatment; one patient assigned amiloride died from metastatic lung cancer, one patient assigned riluzole died from ischaemic heart disease and coronary artery thrombosis, and one patient assigned fluoxetine had a sudden death (primary cause) with multiple sclerosis and obesity listed as secondary causes.
INTERPRETATION


The absence of evidence for neuroprotection in this adequately powered trial indicates that exclusively targeting these aspects of axonal pathobiology in patients with secondary progressive multiple sclerosis is insufficient to mitigate neuroaxonal loss. These findings argue for investigation of different mechanistic targets and future consideration of combination treatment trials. This trial provides a template for future simultaneous testing of multiple disease-modifying medicines in neurological medicine.
FUNDING


Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, UK Multiple Sclerosis Society, and US National Multiple Sclerosis Society.",2020,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","['recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5', '13 clinical neuroscience centres in the UK', '393 patients who were allocated', 'secondary progressive multiple sclerosis (MS-SMART', 'primary cause) with multiple sclerosis and obesity listed as secondary causes', 'Between Jan 29, 2015, and June 22, 2016, 445 patients', 'patients with secondary progressive multiple sclerosis']","['PBVC (amiloride vs placebo', 'amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo', 'fluoxetine', 'neuroprotective drugs', 'amiloride', 'placebo', 'riluzole']","['ischaemic heart disease and coronary artery thrombosis', 'sudden death', 'volumetric MRI percentage brain volume change (PBVC', 'incidence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C1597541', 'cui_str': 'Riluzole 50 MG [Rilutek]'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0242912', 'cui_str': 'Neuroprotective Drugs'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}]","[{'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0010072', 'cui_str': 'Coronary Thrombosis'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",445.0,0.577543,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK. Electronic address: j.chataway@ucl.ac.uk.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'De Angelis', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Connick', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'John', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Prados Carrasco', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Universitat Oberta de Catalunya, Barcelona, Spain; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, Netherlands; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Ourselin', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Braisher', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cranswick', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sue H', 'Initials': 'SH', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Claudia Angela', 'Initials': 'CA', 'LastName': 'Gandini Wheeler-Kingshott', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Brain MRI 3T Research Center, IRCCS Mondino Foundation, Pavia, Italy; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Hawkins', 'Affiliation': 'Keele Medical School and Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Department of Neuroscience, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bastow', 'Affiliation': 'Patient Representative, Multiple Sclerosis Society, London, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Statistics and Epidemiology, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Chandran', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30485-5']
114,32062021,"The effect of Instagram #fitspiration images on young women's mood, body image, and exercise behaviour.","The present study experimentally examined the effects of viewing Instagram images of fitspiration on body dissatisfaction, mood, and exercise behaviour among young women. Further, the study investigated if exercise engagement following exposure to fitspiration images could mitigate any negative effects from image exposure. Participants were 108 women, aged 17-25 years, who were randomly assigned to a 2 (image type: fitspiration, travel inspiration) × 2 (activity type: exercise, quiet rest) between groups design. State body dissatisfaction and mood were assessed at baseline, following image exposure, and following participation in 10 min of walking or quiet rest. Results demonstrated that exposure to fitspiration images led to significantly higher negative mood and body dissatisfaction relative to exposure to travel images. There was no difference in actual exercise behaviour according to image type. However, participants who exercised following exposure to fitspiration images were significantly more likely to report higher subjective exertion ratings. Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition. These findings provide further evidence highlighting fitspiration as a potentially harmful online trend.",2020,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[""young women's mood, body image, and exercise behaviour"", 'Participants were 108 women, aged 17-25 years', 'young women']","['2 (image type: fitspiration, travel inspiration']","['actual exercise behaviour', 'body dissatisfaction, mood, and exercise behaviour', 'Overall, negative mood and body dissatisfaction', 'subjective exertion ratings']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}]",108.0,0.0528909,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[{'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Prichard', 'Affiliation': 'Health & Exercise Sciences, College of Nursing & Health Sciences, Flinders University, Adelaide, South Australia, Australia; SHAPE Research Centre, Flinders University, Adelaide, South Australia, Australia. Electronic address: ivanka.prichard@flinders.edu.au.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Kavanagh', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Maroochydore, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, 85 Commercial Rd, Melbourne, Australia; School of Population Health and Preventive Medicine, Monash University, Melbourne, Australia; Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.002']
115,31993781,Low-dose ofatumumab for multidrug-resistant nephrotic syndrome in children: a randomized placebo-controlled trial.,"BACKGROUND


Children with multidrug-resistant nephrotic syndrome (MRNS) are exposed to drug toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF)) and have an increased risk of kidney disease progression. In small case series, the fully humanized anti-CD20 antibody ofatumumab (OFA) induced remission in children with MRNS when at high dose (10,300 mg/1.73 m 2 ) and partial remission at standard dose (1000 mg/1.73 m 2 ).
METHODS


This double-blind randomized placebo-controlled trial tested the efficacy of single infusion OFA in children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155 ml/min/1.73 m 2  in Placebo arm vs. 65/19-103 ml/min/1.73 m 2  Intervention). Children who had been resistant to a combination of CNI and steroids, with or without MMF or rituximab, were randomized to receive single infusion OFA (1500 mg/1.73 m 2 ) (Intervention arm) or normal saline (Placebo arm). We assessed complete or partial remission of proteinuria after 3 months (primary outcome), and after 6 and 12 months (secondary outcomes), as well as progression to end-stage kidney disease.
RESULTS


After 13 of the planned 50 children (25%) were randomized, the data safety and monitoring board recommended study termination for futility. All 13 children remained nephrotic. Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period. Circulating CD20 was reduced following OFA infusion and remained low for > 3 months.
CONCLUSIONS


OFA given in one single infusion of 1500 mg/1.73 m 2  doses does not induce remission in MRNS. Regimens based on higher OFA doses should be tested in clinical trials.
TRIAL REGISTRATION


https://clinicaltrials.gov: NCT02394106.",2020,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","['Children with multidrug-resistant nephrotic syndrome (MRNS', 'children', 'After 13 of the planned 50 children (25', 'children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155\xa0ml', 'Children who had been resistant to a combination of CNI and steroids, with or without MMF or']","['Placebo', 'rituximab', 'normal saline (Placebo', 'renal replacement therapy', 'placebo', 'single infusion OFA', 'toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF', 'OFA']","['Renal function', 'progression to end-stage kidney disease', 'Circulating CD20', 'complete or partial remission of proteinuria', 'nephrotic']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",5.0,0.799336,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pisani', 'Affiliation': 'Division of Nephrology, School of Nephrology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bodria', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Caridi', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Maria Ludovica', 'Initials': 'ML', 'LastName': ""Degl'Innocenti"", 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy. gmarcoghiggeri@gaslini.org.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04481-y']
116,32145825,"Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial.","BACKGROUND


Urothelial carcinomas of the upper urinary tract (UTUCs) are rare, with poorer stage-for-stage prognosis than urothelial carcinomas of the urinary bladder. No international consensus exists on the benefit of adjuvant chemotherapy for patients with UTUCs after nephroureterectomy with curative intent. The POUT (Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer) trial aimed to assess the efficacy of systemic platinum-based chemotherapy in patients with UTUCs.
METHODS


We did a phase 3, open-label, randomised controlled trial at 71 hospitals in the UK. We recruited patients with UTUC after nephroureterectomy staged as either pT2-T4 pN0-N3 M0 or pTany N1-3 M0. We randomly allocated participants centrally (1:1) to either surveillance or four 21-day cycles of chemotherapy, using a minimisation algorithm with a random element. Chemotherapy was either cisplatin (70 mg/m 2 ) or carboplatin (area under the curve [AUC]4·5/AUC5, for glomerular filtration rate <50 mL/min only) administered intravenously on day 1 and gemcitabine (1000 mg/m 2 ) administered intravenously on days 1 and 8; chemotherapy was initiated within 90 days of surgery. Follow-up included standard cystoscopic, radiological, and clinical assessments. The primary endpoint was disease-free survival analysed by intention to treat with a Peto-Haybittle stopping rule for (in)efficacy. The trial is registered with ClinicalTrials.gov, NCT01993979. A preplanned interim analysis met the efficacy criterion for early closure after recruitment of 261 participants.
FINDINGS


Between June 19, 2012, and Nov 8, 2017, we enrolled 261 participants from 57 of 71 open study sites. 132 patients were assigned chemotherapy and 129 surveillance. One participant allocated chemotherapy withdrew consent for data use after randomisation and was excluded from analyses. Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5). 3-year event-free estimates were 71% (95% CI 61-78) and 46% (36-56) for chemotherapy and surveillance, respectively. 55 (44%) of 126 participants who started chemotherapy had acute grade 3 or worse treatment-emergent adverse events, which accorded with frequently reported events for the chemotherapy regimen. Five (4%) of 129 patients managed by surveillance had acute grade 3 or worse emergent adverse events. No treatment-related deaths were reported.
INTERPRETATION


Gemcitabine-platinum combination chemotherapy initiated within 90 days after nephroureterectomy significantly improved disease-free survival in patients with locally advanced UTUC. Adjuvant platinum-based chemotherapy should be considered a new standard of care after nephroureterectomy for this patient population.
FUNDING


Cancer Research UK.",2020,"Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5).","['261 participants from 57 of 71 open study sites', 'patients with UTUCs after nephroureterectomy with curative intent', '132 patients were assigned chemotherapy and 129 surveillance', 'patients with locally advanced UTUC', 'Between June 19, 2012, and Nov 8, 2017', 'patients with UTUCs.\nMETHODS', 'upper tract urothelial carcinoma', 'patients with UTUC after nephroureterectomy staged as either', '261 participants', '71 hospitals in the UK']","['Chemotherapy', 'systemic platinum-based chemotherapy', 'surveillance or four 21-day cycles of chemotherapy', 'Adjuvant chemotherapy', 'AUC]4·5/AUC5', 'Adjuvant platinum-based chemotherapy', 'carboplatin (area under the curve', 'gemcitabine', 'POUT (Peri-Operative chemotherapy', 'Gemcitabine-platinum combination chemotherapy', 'cisplatin', 'pT2-T4 pN0-N3 M0 or pTany N1-3 M0']","['glomerular filtration rate', 'acute grade 3 or worse treatment-emergent adverse events', 'disease-free survival', '3-year event-free estimates', 'acute grade 3 or worse emergent adverse events', 'disease-free survival analysed by intention to treat with a Peto-Haybittle stopping rule for (in)efficacy']","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027732', 'cui_str': 'Ureteronephrectomy'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",261.0,0.473338,"Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5).","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK; University of Manchester, Manchester, UK. Electronic address: alison.birtle@lthtr.nhs.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolling', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Patient and Public Involvement Representative, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Winterbottom', 'Affiliation': 'Patient and Public Involvement Representative, Fight Bladder Cancer, Chinnor, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Blacker', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Prabir', 'Initials': 'P', 'LastName': 'Chakraborti', 'Affiliation': 'Derby Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul Anthony', 'Initials': 'PA', 'LastName': 'Elliott', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'French', 'Affiliation': 'Southend University Hospital NHS Foundation Trust, Southend, UK.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Jagdev', 'Affiliation': 'The Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jenkins', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Francis Xavier', 'Initials': 'FX', 'LastName': 'Keeley', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Singleton Hospital, Swansea, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30415-3']
117,32333159,The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study.,"INTRODUCTION


Music can have a positive effect on stress and general task performance. This randomized crossover study assessed the effects of preferred music on laparoscopic surgical performance in a simulated setting.
METHODS


Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018. A randomized, 4-period, 4-sequence, 2-treatment crossover study design was used, with each participant acting as its own control. Participants performed four periods, consisting of five peg transfer tasks each period, on a laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure. Participants were randomly allocated to a sequence determining the order of the four periods. The parameters time to task completion, path length and normalized jerk were assessed. Mental workload was assessed using the Surgical Task Load Index questionnaire. Also, heart rate and blood pressure were assessed.
RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music. Also, mental workload was significantly reduced during music [median difference, - 2.41 (interquartile range, - 7.17-1.83) p = 0.021)]. No statistically significant effect was observed on heart rate and blood pressure.
CONCLUSION


Listening to preferred music improves laparoscopic surgical performance and reduces mental workload in a simulated setting.
TRIAL REGISTRATION


Trial registration number: NCT04111679.",2020,"RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","['Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018']","['Preferred Music', 'Listening to preferred music', 'laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure']","['Surgical Task Load Index questionnaire', 'Laparoscopic Surgical Performance', 'Mental workload', 'parameters time to task completion, path length and normalized jerk', 'path length', 'mental workload', 'heart rate and blood pressure', 'laparoscopic surgical performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.444156,"RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","[{'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Oomens', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. pim.oomens@gmail.com.'}, {'ForeName': 'Victor X', 'Initials': 'VX', 'LastName': 'Fu', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent E E', 'Initials': 'VEE', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}]",World journal of surgery,['10.1007/s00268-020-05523-0']
118,32322692,Postal recruitment for genetic studies of preterm birth: A feasibility study.,"Background:  Preterm birth (PTB) represents the leading cause of neonatal death. Large-scale genetic studies are necessary to determine genetic influences on PTB risk, but prospective cohort studies are expensive and time-consuming. We investigated the feasibility of retrospective recruitment of post-partum women for efficient collection of genetic samples, with self-collected saliva for DNA extraction from themselves and their babies, alongside self-recollection of pregnancy and birth details to phenotype PTB.  Methods:  708 women who had participated in the OPPTIMUM trial (a randomised trial of progesterone pessaries to prevent PTB [ISRCTN14568373]) and consented to further contact were invited to provide self-collected saliva from themselves and their babies. DNA was extracted from Oragene OG-500 (adults) and OG-575 (babies) saliva kits and the yield measured by Qubit. Samples were analysed using a panel of Taqman single nucleotide polymorphism (SNP) assays. A questionnaire designed to meet the minimum data set required for phenotyping PTB was included. Questionnaire responses were transcribed and analysed for concordance with prospective trial data.  Results:  Recruitment rate was 162/708 (23%) for self-collected saliva samples and 157/708 (22%) for questionnaire responses. 161 samples from the mother provided DNA with median yield 59.0µg (0.4-148.9µg). 156 samples were successfully genotyped (96.9%). 136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction. 131 baby samples (96.3%) were successfully genotyped. Concordance between self-recalled birth details and prospective birth details ranged from 55 - 99%, median 86%. The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  Conclusion:  This feasibility study demonstrates that self-collected DNA samples from mothers and babies were sufficient for genetic analysis but yields were variable. Self-recollection of pregnancy and birth details was inadequate for accurately phenotyping PTB, highlighting the need for alternative strategies for investigating genetic links with PTB.",2020,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","['708 women who had participated in the OPPTIMUM trial', '136 baby samples had a median yield 11.5µg (0.1-102.7µg); two samples failed DNA extraction', 'preterm birth', '131 baby samples (96.3%) were successfully genotyped']",['progesterone pessaries'],"['Questionnaire responses', 'smoking status', 'Recruitment rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C3839098', 'cui_str': 'Deoxyribonucleic acid extraction technique'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",708.0,0.0435535,"The highest rates of concordance were found for mode of birth (154/156 [99%]), smoking status (151/157 [96%]) and ethnicity (149/156 [96%]).  ","[{'ForeName': 'Oonagh E', 'Initials': 'OE', 'LastName': 'Keag', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Edinburgh Clinical Research Facility, Western General Hospital, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Aoibheann', 'Initials': 'A', 'LastName': 'Bradley', 'Affiliation': 'Queen Margaret Hospital, Dunfermline, KY12 0SU, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Deakin', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Whyte', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Stock', 'Affiliation': 'Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15207.1']
119,32234739,Assessing efficacy of CytoSorb haemoadsorber for prevention of organ dysfunction in cardiac surgery patients with infective endocarditis: REMOVE-protocol for randomised controlled trial.,"INTRODUCTION


Infective endocarditis (IE) is associated with high mortality and morbidity. Multiple organ failure is the main cause of death after surgery for IE. Cardiopulmonary bypass (CPB) can cause a systemic inflammatory response. In a pilot study (REMOVE-pilot (Revealing mechanisms and investigating efficacy of hemoad-sorption for prevention of vasodilatory shock in cardiac surgery patients with infective endocarditis - a multicentric randomized controlled group sequential trial)), we found that plasma profiles of cytokines during and after CPB were higher in patients with IE compared with patients with non-infectious valvular heart disease. Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients. This protocol describes the design of the REMOVE trial on cytokine-adsorbing columns, for example, CytoSorb, for non-selective removal of cytokines. The aim of the REMOVE study is to demonstrate efficacy of CytoSorb on the prevention of multiorgan dysfunction in patients with IE undergoing cardiac surgery.
METHODS AND ANALYSIS


The REMOVE study is an interventional randomised controlled multicenter trial with a group sequential (Pocock) design for assessing efficacy of CytoSorb in patients undergoing cardiac surgery for IE. The change in mean total SOFA (∆ SOFA) score between preoperative and postoperative care will be used as primary endpoint. Data on 30-day mortality, changes in cytokines levels, duration of mechanical ventilation, length of intensive care unit and hospital stay, and postoperative stroke will be collected as secondary endpoints. An interim analysis will be conducted after including 25 participating patients per study arm (with a focus on feasibility of the recruitment as well as differences in cytokines and cell-free DNA levels).
ETHICS AND DISSEMINATION


The protocol was approved by the institutional review board and ethics committee of the University of Jena as well as by the corresponding ethics committee of each participating study centre. The results will be published in a renowned international medical journal, irrespective of the outcomes of the study.
TRIAL REGISTRATION NUMBER


The ClinicalTrials.gov registry (NCT03266302).",2020,Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients.,"['cardiac surgery patients with infective endocarditis ', 'patients with IE compared with patients with non-infectious valvular heart disease', 'patients undergoing cardiac surgery for IE', 'patients with IE undergoing cardiac surgery', 'cardiac surgery patients with infective endocarditis']","['Cardiopulmonary bypass (CPB', 'hemoad-sorption', 'CytoSorb', 'CytoSorb haemoadsorber']","['cytokines and cell-free DNA levels', 'hospital mortality', '30-day mortality, changes in cytokines levels, duration of mechanical ventilation, length of intensive care unit and hospital stay, and postoperative stroke', 'mean total SOFA (∆ SOFA) score', 'multiorgan dysfunction', 'Sequential Organ Failure Assessment (SOFA) scores']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",25.0,0.305827,Sequential Organ Failure Assessment (SOFA) scores on the first and second postoperative days and in-hospital mortality were also higher in IE patients.,"[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Diab', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Platzer', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Guenther', 'Affiliation': 'Department of Neurology, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sponholz', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Velichkov', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital - Friedrich Schiller University, Jena, Thuringia, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital - Friedrich Schiller University of Jena, Jena, Thuringia, Germany Doenst@med.uni-jena.de.'}]",BMJ open,['10.1136/bmjopen-2019-031912']
120,32213517,Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.,"INTRODUCTION


Persistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.
METHODS AND ANALYSIS


We conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.
ETHICS AND DISSEMINATION


The Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.
TRIAL REGISTRATION NUMBER


NCT02937142.",2020,99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual.,"['99 adolescents who met inclusion criteria and consented to participation', 'patients in Norway and elsewhere', 'adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication', 'adolescents with ADHD', 'adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway']","['12-week group cognitive-behavioural therapy (CBT) programme', 'CBT group therapy', 'CBT', 'Cognitive-behavioural group therapy', 'control group receiving treatment as usual']",['change in symptom scores on the ADHD Rating Scale-IV'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}]",99.0,0.131764,99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual.,"[{'ForeName': 'Torunn Stene', 'Initials': 'TS', 'LastName': 'Nøvik', 'Affiliation': 'Department of Child and Adolescent Psychiatry, St Olav University Hospital, Trondheim, Norway torunn.stene.novik@stolav.no.'}, {'ForeName': 'Anne-Lise Juul', 'Initials': 'AJ', 'LastName': 'Haugan', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Psychology Services Limited, London, UK.'}, {'ForeName': 'Anne Mari', 'Initials': 'AM', 'LastName': 'Sund', 'Affiliation': 'Department of Child and Adolescent Psychiatry, St Olav University Hospital, Trondheim, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-032839']
121,32217557,"Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial.","INTRODUCTION


Subarachnoid haemorrhage (SAH) from a ruptured cerebral aneurysm carries high morbidity and mortality. Despite huge advances in techniques to secure the aneurysm, there has been little progress in the treatment of the deleterious effects of the haemorrhage.Sulforaphane is an Nrf2 inducer with anti-oxidant and anti-inflammatory properties. It has been shown to improve clinical outcome in experimental models of SAH, but is unstable. SFX-01 (Evgen Pharma) is a novel composition comprised of synthetic sulforaphane stabilised within an α-cyclodextrin complex. On ingestion, the complex releases sulforaphane making SFX-01 an ideal vehicle for delivery of sulforaphane.
METHODS AND ANALYSIS


The objective of the study is to assess the safety, pharmacokinetics and efficacy of SFX-01. This is a prospective, multicentre, randomised, double-blind placebo-controlled trial in patients aged 18-80 years with aneurysmal subarachnoid haemorrhage in the previous 48 hours. 90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.Safety will be assessed using blood tests and adverse event reporting.Pharmacokinetics will be assessed based on paired blood and cerebrospinal fluid (CSF) sulforaphane levels on day 7. A subgroup will have hourly samples taken during 6 hours post-dosing on days 1 and 7. Pharmacodynamics will be assessed by haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery will be measured by transcranial Doppler ultrasound.Clinical outcomes will be assessed at days 28, 90 and 180 with modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke. MRI at 6 months including quantitative susceptibility mapping and volumetric T1 will measure iron deposition and cortical volume.Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity will be primary outcomes and all others secondary.
ETHICS AND DISSEMINATION


Ethical approval was obtained from South Central Hampshire A committee. Outcomes of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT02614742.",2020,90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.,"['after subarachnoid haemorrhage (SAS', '90 patients', 'patients aged 18-80 years with aneurysmal subarachnoid haemorrhage in the previous 48\u2009hours']","['SFX-01', 'placebo', 'Sulforaphane']","['paired blood and cerebrospinal fluid (CSF) sulforaphane levels', 'modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke', 'haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery', 'safety, pharmacokinetics and efficacy', 'Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity']","[{'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}]","[{'cui': 'C0005768'}, {'cui': 'C0007807'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0222045'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",90.0,0.684954,90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.,"[{'ForeName': 'Ardalan H', 'Initials': 'AH', 'LastName': 'Zolnourian', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK a.zolnourian@soton.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Franklin', 'Affiliation': 'Evgen Pharma, Liverpool, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Galea', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Diederik Oliver', 'Initials': 'DO', 'LastName': 'Bulters', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028514']
122,31537504,Prospective Comparison of 70-kVp Single-Energy CT versus Dual-Energy CT: Which is More Suitable for CT Angiography with Low Contrast Media Dosage?,"RATIONALE AND OBJECTIVES


To compare the objective and subjective image qualities between single-energy computed tomography (CT) at 70 kVp and virtual monoenergetic imaging (VMI) of dual-source dual-energy CT for CT angiography with 180 mgI/kg.
MATERIALS AND METHODS


Total 63 patients scanned with 180 mgI/kg were randomly divided into two groups: Group A (32 patients) underwent CT angiography at 70-kVp, and Group B (31 patients) underwent dual-energy CT. VMI sets were generated at 10-keV increments between 40 and 100 keV. We calculated aortic attenuation, contrast-to-noise-ratio (CNR), signal-to-noise-ratio, figure of merit of CNR, and effective dose for each protocol. Three radiologists scored overall image quality and various arteries' visibility using a four-point scale. Quantitative and qualitative comparisons between 70 kVp and VMI with the highest CNR were performed with the two-tailed t test or Kruskal-Wallis test.
RESULTS


The 40-keV images offered the highest CNR among VMIs. Aortic attenuation at 70 kVp was significantly lower than that at 40 keV (p < 0.001). However, the signal-to-noise-ratio, CNR, and figure of merit of CNR were significantly higher at 70 kVp than those at 40-keV (p < 0.001, p < 0.05, and p < 0.05, respectively). The effective dose of each group was almost equal. The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


Aortic attenuation at 70 kVp with 180 mg I/kg was lower than that of VMI at 40 keV, and the objective and subjective image qualities were higher at 70 kVp than those at 40 keV.",2020,"The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


",['Total 63 patients scanned with 180 mgI/kg'],"['70-kVp Single-Energy CT versus Dual-Energy CT', 'single-energy computed tomography (CT) at 70 kVp and virtual monoenergetic imaging (VMI) of dual-source dual-energy CT for CT angiography with 180 mgI/kg', 'CT angiography at 70-kVp, and Group B (31 patients) underwent dual-energy CT']","['signal-to-noise-ratio, CNR, and figure of merit of CNR', 'Aortic attenuation', 'calculated aortic attenuation, contrast-to-noise-ratio (CNR), signal-to-noise-ratio, figure of merit of CNR, and effective dose', 'qualitative visibility scores', 'objective and subjective image qualities']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441633'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",63.0,0.0199655,"The qualitative visibility scores for various arteries, except the ascending and upper-abdominal aorta, were also better at 70 kVp than those at 40 keV.
CONCLUSION


","[{'ForeName': 'Morikatsu', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan. Electronic address: y_morikatsu@hotmail.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakaura', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Takada', 'Initials': 'T', 'LastName': 'Sentaro', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Tanoue', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Hatsuki', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Department of Radiology, Amakusa Medical Center, 854-1 Jikiba, Kameba, Amakusa, Kumamoto 863-0046, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Radiology, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Naritsugu', 'Initials': 'N', 'LastName': 'Sakaino', 'Affiliation': 'Department of Cardiovascular Internal Medicine, Amakusa Medical Center, Amakusa, Kumamoto, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Surgery, Amakusa Medical Center, Amakusa, Kumamoto, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.'}]",Academic radiology,['10.1016/j.acra.2019.07.016']
123,31809359,Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me).,"BACKGROUND


HIV testing is critical to HIV prevention and care. Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen. Novel interventions to increase HIV testing rates among young Black men who have sex with men and transwomen are needed.
METHODS


A randomized controlled trial among 236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach. Participants completed a computerized baseline assessment and were randomized to electronically receive either a personalized recommendation or standard HIV testing information. Follow-up surveys were conducted online at 3 and 6 months.
RESULTS


Retention was 92% and 93% at 3-month and 6-month follow-up, respectively. At baseline, 41% of participants reported that they tested for HIV in the past 3 months and another 25% between 4 and 6 months ago. Intent-to-treat analyses found that participants randomized to the experimental arm (personalized recommendation) were not significantly more likely to test for HIV compared with participants in the standard HIV testing information control arm at 3 months (76% vs. 71%; P = 0.40) and 6 months (73% vs. 72%; P = 0.81), respectively.
CONCLUSIONS


This study evaluated an innovative intervention to increase HIV testing by matching individuals to optimal HIV testing approaches. Participants in both arms increased past 3-month HIV testing, suggesting that providing information on options and/or raising risk awareness is sufficient to significantly increase HIV testing.
TRIAL REGISTRATION


ClinicalTrial.gov NCT02834572 https://clinicaltrials.gov/ct2/show/NCT02834572.",2020,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"['young Black men who have sex with men and transwomen', 'Young Black Men and Transwomen', 'young Black men who have sex with men and transwomen are needed', '236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach', 'Who Have Sex With Men or Transwomen to HIV Testing Options in New York City ']","['personalized recommendation or standard HIV testing information', 'Novel interventions']",['HIV testing rates'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",236.0,0.115138,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Frye', 'Affiliation': 'Department of Community Health and Social Medicine,Department of Community Health and Social Medicine, Sophie Davis Biomedical Education Program, City University of New York School of Medicine, City University of New York, New York, NY.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Nandi', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Chiasson', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Wilton', 'Affiliation': 'Department of Human Development, Binghamton University, Binghamton, NY.'}, {'ForeName': 'DaShawn', 'Initials': 'D', 'LastName': 'Usher', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Biostatistics and Institute for Health, Health Care Policy and Aging Research, Rutgers, The State University of New Jersey, Piscataway, NJ.'}, {'ForeName': 'Beryl A', 'Initials': 'BA', 'LastName': 'Koblin', 'Affiliation': 'Independent Consultant, Metuchen, NJ.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002223']
124,30298422,Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial.,"BACKGROUND


Early mobilization is one essential item within the enhanced recovery after surgery (ERAS) concept, but lacks solid evidence and a standardized assessment. The aim was to monitor and increase the postoperative mobilization of patients after major visceral surgery by providing a continuous step count feedback using activity tracking wristbands.
METHODS


The study was designed as a randomized controlled single-center trial (NCT02834338) with two arms (open and laparoscopic surgery). Participants were randomized to either receive feedback of their step counts using an activity tracker wristband or not. The primary study endpoint was the mean step count during the first 5 postoperative days (PODs).
RESULTS


A total of 132 patients were randomized. After laparoscopic operations, the average step count during PODs 1-5 was significantly increased by the feedback compared with the control group (P < 0.001); the cumulative step count (9867 versus 6103, P = 0.037) and activity time were also significantly increased. These results could not be confirmed in the open surgery arm. Possible reasons were a higher age and significantly more comorbidities in the open intervention group. Patients who achieved more than the median cumulative step count had a significantly shorter hospital stay and lower morbidity in both arms. The average step count also correlated with the length of hospital stay (R = - 0.341, P < 0.001).
CONCLUSION


This study is the first randomized controlled trial investigating the use and feasibility of activity tracking to monitor and enhance postoperative mobilization in abdominal surgery. Our results demonstrate that activity tracking can enhance perioperative mobilization after laparoscopic surgery.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02834338.",2019,"After laparoscopic operations, the average step count during PODs 1-5 was significantly increased by the feedback compared with the control group (P < 0.001); the cumulative step count (9867 versus 6103, P = 0.037) and activity time were also significantly increased.","['132 patients were randomized', 'patients after major visceral surgery', 'abdominal surgery', 'Major Visceral Surgery']","['feedback of their step counts using an activity tracker wristband or not', 'laparoscopic surgery', 'Activity Tracking', 'activity tracking']","['activity time', 'perioperative mobilization', 'hospital stay and lower morbidity', 'length of hospital stay', 'postoperative mobilization', 'cumulative step count', 'mean step count during the first 5 postoperative days (PODs', 'average step count during PODs 1-5']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",132.0,0.165999,"After laparoscopic operations, the average step count during PODs 1-5 was significantly increased by the feedback compared with the control group (P < 0.001); the cumulative step count (9867 versus 6103, P = 0.037) and activity time were also significantly increased.","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wolk', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linke', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bogner', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Sturm', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Meißner', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Müssle', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Nuh N', 'Initials': 'NN', 'LastName': 'Rahbari', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Welsch', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany. thilo.welsch@uniklinikum-dresden.de.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-3998-0']
125,31274072,Skill Transference of a Probe-Tube Placement Training Simulator.,"BACKGROUND


Probe-tube placement is a necessary step in hearing aid verification which needs ample hands-on experience and confidence before performing in clinic. To improve the methods of training in probe-tube placement, a manikin-based training simulator was developed consisting of a 3D-printed head, a flexible silicone ear, and a mounted optical tracking system. The system is designed to provide feedback to the user on the depth and orientation of the probe tube, and the time required to finish the task. Although a previous validation study was performed to determine its realism and teachability with experts, further validation is required before implementation into educational settings.
PURPOSE


This study aimed to examine the skill transference of a newly updated probe-tube placement training simulator to determine if skills learned on this simulator successfully translate to clinical scenarios.
RESEARCH DESIGN


All participants underwent a pretest in which they were evaluated while performing a probe-tube placement and real-ear-to-coupler difference (RECD) measurement on a volunteer. Participants were randomized into one of two groups: the simulator group or the control group. During a two-week training period, all participants practiced their probe-tube placement according to their randomly assigned group. After two weeks, each participant completed a probe-tube placement on the same volunteer as a posttest scenario.
STUDY SAMPLE


Twenty-five novice graduate-level student clinicians.
DATA COLLECTION AND ANALYSIS


Participants completed a self-efficacy questionnaire and an expert observer completed a questionnaire evaluating each participant's performance during the pre- and posttest sessions. RECD measurements were taken after placing the probe tube and foam tip in the volunteer's ear. Questionnaire results were analyzed through nonparametric t-tests and analysis of variance, whereas RECD results were analyzed using a nonlinear mixed model method.
RESULTS


Results suggested students in the simulator group were less likely to contact the tympanic membrane when placing a probe tube, appeared more confident, and had better use of the occluding foam tip, resulting in more improved RECD measurements.
CONCLUSIONS


The improved outcomes for trainees in the simulator group suggest that supplementing traditional training with the simulator provides useful benefits for the trainees, thereby encouraging its usage and implementation in educational settings.",2020,"RESULTS


Results suggested students in the simulator group were less likely to contact the tympanic membrane when placing a probe tube, appeared more confident, and had better use of the occluding foam tip, resulting in more improved RECD measurements.
",['Twenty-five novice graduate-level student clinicians'],[],"['RECD measurements', 'tympanic membrane', 'self-efficacy questionnaire']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],"[{'cui': 'C0041445', 'cui_str': 'Eardrum'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0379215,"RESULTS


Results suggested students in the simulator group were less likely to contact the tympanic membrane when placing a probe tube, appeared more confident, and had better use of the occluding foam tip, resulting in more improved RECD measurements.
","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Koch', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Saleh', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Folkeard', 'Affiliation': 'National Centre for Audiology, Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Moodie', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Conner', 'Initials': 'C', 'LastName': 'Janeteas', 'Affiliation': 'Cimetrix Solutions Inc., Oshawa, ON, Canada.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Agrawal', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Hanif M', 'Initials': 'HM', 'LastName': 'Ladak', 'Affiliation': 'School of Biomedical Engineering, Western University, London, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Scollie', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18054']
126,31302489,Calf muscle stretching is ineffective in increasing ankle range of motion or reducing plantar pressures in people with diabetes and ankle equinus: A randomised controlled trial.,"BACKGROUND


Limited ankle dorsiflexion, or equinus, is associated with elevated plantar pressures, which have been implicated in the development and non-healing of foot ulcer. A stretching intervention may increase ankle dorsiflexion and reduce plantar pressures in people with diabetes.
METHODS


Two arm parallel randomised controlled trial from September 2016 to October 2017. Adults with diabetes and ankle equinus (≤5° dorsiflexion) were randomly allocated to receive an 8 week static calf stretching intervention or continue with their normal activities. Primary outcome measures were change in weight bearing and non-weight bearing ankle dorsiflexion and forefoot peak plantar pressure. Secondary outcome measures were forefoot pressure time integrals and adherence to the stretching intervention.
FINDINGS


68 adults (mean (standard deviation) age and diabetes duration 67.4 (10.9) years and 14.0 (10.8) years, 64.7% male) were randomised to stretch (n = 34) or usual activity (n = 34). At follow up, no significant differences were seen between groups (adjusted mean difference) for non-weight (+1.3°, 95% CI:-0.3 to 2.9, p = 0.101) and weight bearing ankle dorsiflexion (+0.5°, 95% CI:-2.6 to 3.6, p = 0.743) or forefoot in-shoe (+1.5 kPa, 95% CI:-10.0 to 12.9, p = 0.803) or barefoot peak pressures (-19.1 kPa, 95% CI:-96.4 to 58.1, p = 0.628). Seven of the intervention group and two of the control group were lost to follow up.
INTERPRETATION


Our data failed to show a statistically significant or clinically meaningful effect of static calf muscle stretching on ankle range of motion, or plantar pressures, in people with diabetes and ankle equinus.",2019,"Our data failed to show a statistically significant or clinically meaningful effect of static calf muscle stretching on ankle range of motion, or plantar pressures, in people with diabetes and ankle equinus.","['19.1\u202fkPa', 'people with diabetes and ankle equinus', 'Two arm parallel randomised controlled trial from September 2016 to October 2017', 'Adults with diabetes and ankle equinus (≤5° dorsiflexion', 'people with diabetes', '68 adults (mean (standard deviation) age and diabetes duration 67.4 (10.9) years and 14.0 (10.8) years, 64.7% male']","['usual activity', 'static calf stretching intervention or continue with their normal activities', 'Calf muscle stretching', 'stretching intervention']","['weight bearing ankle dorsiflexion', 'change in weight bearing and non-weight bearing ankle dorsiflexion and forefoot peak plantar pressure', 'ankle dorsiflexion and reduce plantar pressures', 'forefoot pressure time integrals and adherence to the stretching intervention', 'plantar pressures', 'non-weight', 'ankle range of motion, or plantar pressures', 'barefoot peak pressures ']","[{'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing (finding)'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}]",68.0,0.224455,"Our data failed to show a statistically significant or clinically meaningful effect of static calf muscle stretching on ankle range of motion, or plantar pressures, in people with diabetes and ankle equinus.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Searle', 'Affiliation': 'School of Health Sciences, Faculty of Health, University of Newcastle, Australia. Electronic address: Angela.Searle@newcastle.edu.au.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Spink', 'Affiliation': 'School of Health Sciences, Faculty of Health, University of Newcastle, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, Australia.'}, {'ForeName': 'Vivienne H', 'Initials': 'VH', 'LastName': 'Chuter', 'Affiliation': 'School of Health Sciences, Faculty of Health, University of Newcastle, Australia; School of Psychology, Faculty of Science and Information Technology, University of Newcastle, Australia.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.07.005']
127,32300129,Mindfulness Meditation Activates Altruism.,"Clinical evidence suggests that mindfulness meditation reduces anxiety, depression, and stress, and improves emotion regulation due to modulation of activity in neural substrates linked to the regulation of emotions and social preferences. However, less was known about whether mindfulness meditation might alter pro-social behavior. Here we examined whether mindfulness meditation activates human altruism, a component of social cooperation. Using a simple donation game, which is a real-world version of the Dictator's Game, we randomly assigned 326 subjects to a mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation. Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics. We also found a larger treatment effect of meditation among those who did not go to college (p < 0.001) and those who were under 25 years of age (p < 0.001), with both subject groups contributing virtually nothing in the control condition. Our results imply high context modularity of human altruism and the development of intervention approaches including mindfulness meditation to increase social cooperation, especially among subjects with low baseline willingness to contribute.",2020,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.",['326 subjects to a'],"['mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation', 'mindfulness meditation']","['anxiety, depression, and stress, and improves emotion regulation']","[{'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",326.0,0.0125002,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.","[{'ForeName': 'Sage K', 'Initials': 'SK', 'LastName': 'Iwamoto', 'Affiliation': 'College of Letters & Sciences, UC Berkeley, Berkeley, CA, 94720, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Mindful Awareness Research Center and Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience at UCLA, and Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishi', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, 90095, United States. akihironishi@ucla.edu.'}]",Scientific reports,['10.1038/s41598-020-62652-1']
128,32332265,Comparison of conventional and fibreoptic-guided advance of left-sided double-lumen tube during endobronchial intubation: A randomised controlled trial.,"BACKGROUND


Postoperative sore throat and airway injuries are relatively common after double-lumen tube (DLT) intubation.
OBJECTIVE


The current study aimed to evaluate the effects of fibreoptic-guided advance of DLT on postoperative sore throat and airway injuries associated with intubation.
DESIGN


A randomised controlled study.
SETTING


Tertiary hospital, Seongnam, Korea, from January 2018 to January 2019.
PATIENTS


One hundred twenty three patients undergoing one-lung ventilation with a left-side DLT were randomised into two groups: 62 in the conventional group and 61 in the fibreoptic-guided group.
INTERVENTION


After entering the glottis, the DLT was rotated left 90° and advanced blindly into the left main bronchus in the conventional group. In the fibreoptic-guided group, DLT was advanced into the main bronchus under the guide of fibreoptic bronchoscope, which had been passed through the bronchial lumen and inserted into the left main bronchus.
MAIN OUTCOME MEASURES


The primary outcome was postoperative sore throat at 24 h after operation. The airway injuries were also examined using a bronchoscope during extubation.
RESULTS


At postoperative 24 h, the fibreoptic-guided group showed lower pain score (P = 0.001) and lower incidence (risk ratio [95% CI]: 0.2 [0.1 to 0.5], P < 0.001) of sore throat, compared with the conventional group. Moreover, tracheal injury was more severe in the conventional group than in the fibreoptic group (P = 0.003). Vocal cord injuries also occurred less frequently in the fibreoptic-guided group (risk ratio [95% CI]: 0.4 [0.2 to 1.0], P = 0.036).
CONCLUSION


The fibreoptic-guided advancement seems to reduce irritation to the airway, leading less postoperative complications.
TRIAL REGISTRATION


ClinicalTrials.gov, registration number: NCT03368599.",2020,"At postoperative 24 h, the fibreoptic-guided group showed lower pain score (P = 0.001) and lower incidence (risk ratio [95% CI]: 0.2 [0.1 to 0.5], P < 0.001) of sore throat, compared with the conventional group.","['One hundred twenty three patients undergoing one-lung ventilation with a left-side DLT', 'Tertiary hospital, Seongnam, Korea, from January 2018 to January 2019']","['fibreoptic-guided group', 'conventional and fibreoptic-guided advance of left-sided double-lumen tube during endobronchial intubation', 'fibreoptic-guided advance of DLT']","['postoperative sore throat', 'tracheal injury', 'postoperative sore throat and airway injuries', 'pain score', 'Vocal cord injuries']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0396632', 'cui_str': 'Endobronchial intubation'}, {'cui': 'C0441299', 'cui_str': 'Double lumen tube'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0149992', 'cui_str': 'Injury of trachea'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}]",123.0,0.170488,"At postoperative 24 h, the fibreoptic-guided group showed lower pain score (P = 0.001) and lower incidence (risk ratio [95% CI]: 0.2 [0.1 to 0.5], P < 0.001) of sore throat, compared with the conventional group.","[{'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'From Department of Anaesthesiology and Pain Medicine (J-WP, JHJ, HP, YKB, S-JP, S-HH, J-HK), Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Bundang Hospital, Seongnam (S-WC) and Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, South Korea (S-HH, J-HK).'}, {'ForeName': 'Ji H', 'Initials': 'JH', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Yu K', 'Initials': 'YK', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Seong-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Sung-Woo', 'Initials': 'SW', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001216']
129,31974691,Refining the criteria for immediate total-body CT after severe trauma.,"OBJECTIVES


Initial trauma care could potentially be improved when conventional imaging and selective CT scanning is omitted and replaced by immediate total-body CT (iTBCT) scanning. Because of the potentially increased radiation exposure by this diagnostic approach, proper selection of the severely injured patients is mandatory.
METHODS


In the REACT-2 trial, severe trauma patients were randomized to iTBCT or conventional imaging and selective CT based on predefined criteria regarding compromised vital parameters, clinical suspicion of severe injuries, or high-risk trauma mechanisms in five trauma centers. By logistic regression analysis with backward selection on the 15 study inclusion criteria, a revised set of criteria was derived and subsequently tested for prediction of severe injury and shifts in radiation exposure.
RESULTS


In total, 1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15). Backward logistic regression resulted in a revised set consisting of nine original and one adjusted criteria. Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%). Sensitivity decreased by 9% (95% CI 7-11%). The area under the receiver operating characteristics curve remained equal and was 0.80 (95% CI 0.77-0.83), original set 0.80 (95% CI 0.77-0.83). The revised set retains 8.78 mSv (95% CI 6.01-11.56) for 36% of the non-severely injured patients.
CONCLUSIONS


Selection criteria for iTBCT can be reduced from 15 to 10 clinically criteria. This improves the positive predictive value for severe injury and reduces radiation exposure for less severely injured patients.
KEY POINTS


• Selection criteria for iTBCT can be reduced to 10 clinically useful criteria. • This reduces radiation exposure in 36% of less severely injured patients. • Overall discriminative capacity for selection of severely injured patients remained equal.",2020,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"['1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15', 'severe trauma patients']","['iTBCT or conventional imaging and selective CT', 'conventional imaging and selective CT scanning']","['Positive predictive value', 'Sensitivity', 'radiation exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",1083.0,0.196791,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"[{'ForeName': 'Kaij', 'Initials': 'K', 'LastName': 'Treskes', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. k.treskes@amsterdamumc.nl.'}, {'ForeName': 'Teun P', 'Initials': 'TP', 'LastName': 'Saltzherr', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, Den Haag, the Netherlands.'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edwards', 'Affiliation': 'Trauma Unit, Department of Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Benn J A', 'Initials': 'BJA', 'LastName': 'Beuker', 'Affiliation': 'Trauma Unit, Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': ""Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hohmann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Basel Hospital, Petersgraben, 4031, Basel, Switzerland.'}, {'ForeName': 'Jan S K', 'Initials': 'JSK', 'LastName': 'Luitse', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anaesthesiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit/Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06503-2']
130,32324065,Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.,"Objective:  To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods:  Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Results:  Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at week 52 was -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at week 26 was -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin. Conclusion:  Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM.  Clinicaltrials.gov identifiers:  NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.",2020,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"['1178 Hispanic/Latino patients', 'Hispanic/Latino patients with type 2 diabetes (T2DM', 'Hispanic/Latino patients with type 2 diabetes mellitus', 'Hispanic/Latino patients', 'Hispanic/Latino patients with T2DM', 'data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies']","['placebo', 'Ertugliflozin', 'glimepiride', 'ertugliflozin']","['Ertugliflozin efficacy', 'efficacy and safety', 'HbA1c, BW, and SBP', 'glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP', 'Reductions in BW and SBP', 'Efficacy and safety']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.084421,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1760227']
131,32324307,"Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial.","BACKGROUND


Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown.
METHODS


Smart Step is a pilot randomized trial of smartphone-enabled HBET vs walking advice in patients with symptomatic PAD in an inner-city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone-based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6-minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year.
RESULTS


A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants.
CONCLUSIONS


The potential significance of this trial will be to provide preliminary evidence of a home-based, ""mobile-first"" approach for delivering a structured exercise rehabilitation program. Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.",2020,"Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.","['patients with symptomatic peripheral arterial disease', 'patients with symptomatic PAD in an inner-city hospital', 'patients with symptomatic peripheral arterial disease (PAD', '15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years']","['Supervised exercise therapy (SET', 'Fitbit Charge HR', 'smartphone-enabled HBET vs walking advice', 'Home-based exercise therapy (HBET', 'Smartphone-enabled HBET', 'smartphone-enabled, home-based exercise program', 'smartphone app with daily exercise reminders and educational content']","['degree of engagement with the smartphone app and changes in health behaviors and quality of life scores', 'mean (SD) ABI and 6MWT', '6-minute walking test (6MWT) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.172339,"Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vakili', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alaaeddin', 'Initials': 'A', 'LastName': 'Alrohaibani', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Smah M', 'Initials': 'SM', 'LastName': 'Abdelhamid', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Gordon', 'Affiliation': 'INTERVENT International, Savannah, Georgia, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thiel', 'Affiliation': 'INTERVENT International, Savannah, Georgia, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Benarroch-Gampel', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Teodorescu', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Minton', 'Affiliation': 'Grady Memorial Hospital, Atlanta, Georgia, USA.'}, {'ForeName': 'Nanette K', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Clinical cardiology,['10.1002/clc.23362']
132,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I.
RESULTS


Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
CONCLUSIONS


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
133,32282034,"Effects of Telephone and Short Message Service Support on Infant Feeding Practices, ""Tummy Time,"" and Screen Time at 6 and 12 Months of Child Age: A 3-Group Randomized Clinical Trial.","Importance


There is limited information as to whether telephone or short message service (SMS) support is effective in improving infant feeding practices and tummy time and reducing screen time.
Objective


To determine the effectiveness of either nurse-led telephone or SMS support in improving infant feeding practices and tummy time and reducing screen time.
Design, Setting, and Participants


This study was part of a 2-year, 3-group parallel, randomized clinical trial conducted from February 23, 2017, to November 30, 2018, among 1155 women in the third trimester of pregnancy in New South Wales, Australia. It reports the main outcomes at 6 and 12 months of child age. All analyses were conducted on an intention-to-treat principle.
Interventions


The intervention consisted of staged information booklets mailed to the intervention groups, each followed by either a nurse-led telephone support session or SMS intervention, antenatally and at 1, 3, 5, 7, and 10 months after birth.
Main Outcomes and Measures


The primary outcomes were infant feeding practices at both 6 and 12 months and tummy time at 6 months. The secondary outcome was screen time at 12 months.
Results


Of 1155 mothers, 947 (82%; mean [SD] age, 32.5 [5.0] years) completed follow-up surveys at 6 months; 920 mothers (80%) completed follow-up surveys at 12 months. Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63 [95% CI, 1.18-2.25]) at 6 months and higher odds of having no screen time (AOR, 1.80 [95% CI, 1.28-2.53]) and no bottle at bedtime (AOR, 1.73 [95% CI, 1.23-2.42]) at 12 months. Use of SMS also led to higher odds than the control group of having no screen time (AOR, 1.28 [95% CI, 1.08-1.52]) and having no bottle at bedtime (AOR, 1.29 [95% CI, 1.10-1.51]) at 12 months. No significant differences were found in breastfeeding rates between the telephone support, SMS support, and control groups.
Conclusions and Relevance


Both the nurse-led telephone support and SMS interventions were effective in reducing screen time and bottle use at bedtime. Telephone support was also effective in promoting the appropriate timing of the introduction of solid foods, early-start tummy time, and cup use.
Trial Registration


http://anzctr.org.au Identifier: ACTRN12616001470482.",2020,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","['at 6 and 12 Months of Child Age', '1155 mothers, 947 (82%; mean [SD] age, 32.5 [5.0] years) completed follow-up surveys at 6 months; 920 mothers (80%) completed follow-up surveys at 12 months', 'February 23, 2017, to November 30, 2018, among 1155 women in the third trimester of pregnancy in New South Wales, Australia']","['Telephone and Short Message Service Support', 'nurse-led telephone or SMS support', 'http://anzctr.org.au Identifier', 'SMS', 'nurse-led telephone support session or SMS intervention']","['Infant Feeding Practices, ""Tummy Time,"" and Screen Time', 'breastfeeding rates', 'infant feeding practices at both 6 and 12 months and tummy time', 'screen time and bottle use', 'screen time at 12 months']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0996758,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","[{'ForeName': 'Li Ming', 'Initials': 'LM', 'LastName': 'Wen', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taki', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Buchanan', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bedford', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Philayrath', 'Initials': 'P', 'LastName': 'Phongsavan', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Baur', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0215']
134,31954696,Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial.,"OBJECTIVE


To determine the differences between clinical effects of electroacupuncture and biofeedback therapy in addition to conventional treatment in patients with cervical myofascial pain syndrome (MPS).
DESIGN


Randomized clinical trial.
SETTING


Physical medicine and rehabilitation clinic of a university hospital.
PARTICIPANTS


Fifty patients (N=50) aged 25-55 years of both sexes with chronic neck pain diagnosed with MPS (characterized by trigger points within taut bands) were randomly assigned to 2 equal groups of 25 individuals.
INTERVENTIONS


The patients in electroacupuncture group were treated with standard acupuncture and concomitant electrical stimulation; those in biofeedback group received visual electromyography biofeedback therapy for muscle activity and relaxation. Both groups received the intervention 2 times a week for a total of 6 sessions. Basic exercise training and medicines were administered for all the patients.
MAIN OUTCOME MEASURES


Pain severity based on the visual analog scale (VAS), functional status using Neck Disability Index (NDI), cervical range of motion (ROM) using and inclinometer, and pressure pain threshold (PPT) using an algometer were evaluated before and at 3 and 12 weeks after the treatment. Primary outcome was defined as 20% reduction in the 3-month neck pain and dysfunction compared to baseline, assessed through the NDI.
RESULTS


Fifty patients (39 women, 11 men) with a mean age (years) ± SD of 39.0±5.5 and neck pain duration (weeks) of 6.0±2.2 were analyzed. All parameters, except for PPT of the lower trapezius and paravertebral muscles were improved significantly in both groups, while baseline values were controlled. The primary outcome was achieved more significantly in the acupuncture group than in the biofeedback group: 20 (80.0%) vs 10 (40.0%); rate ratio=2 with 95% confidence interval (CI), 1.19-3.36; number needed to treat (NNT)=2.5 with 95% CI, 1.54-6.58. Advantages of acupuncture over biofeedback were observed according to values obtained from the NDI, VAS, extension and left lateral-bending ROM, and PPT on the left upper trapezius after the last session of intervention until 3 months (P<.05).
CONCLUSIONS


Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment. However, intergroup differences showed priority of acupuncture in some parameters vs biofeedback. Thus, electroacupuncture seems to be a better complementary modality for treatment of MPS in the neck and upper back area.",2020,Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment.,"['50 patients (39 women, 11 men) with an average age of 39.0 (5.5) years old and neck pain duration of 6.0(2.2) weeks were analyzed', '50 patients aged 25-55 years old of both genders with chronic neck pain diagnosed to have MPS (characterized by trigger points within taut bands', 'Physical medicine and rehabilitation clinic of a university hospital', 'patients with cervical Myofascial Pain Syndrome (MPS']","['standard acupuncture concomitant electrical stimulation and those in biofeedback group received visual EMG-biofeedback therapy', 'acupuncture', 'Electroacupuncture and Biofeedback', 'electroacupuncture', 'electro-acupuncture and biofeedback therapy']","['Pain severity based on Visual Analogue Scale (VAS), functional status using Neck Disability Index (NDI), cervical Range of Motion (ROM) using inclinometer and Pressure Pain Threshold (PPT', 'PPT of lower trapezius and paravertebral muscles', 'Myofascial Pain', 'Neck and Upper Back', '3-month neck pain and dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C4019022', 'cui_str': 'Taut (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0027073', 'cui_str': 'Myofascial Pain Syndromes'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",39.0,0.112742,Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment.,"[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Eslamian', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: fariba_eslamian@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jahanjoo', 'Affiliation': 'Road Traffic Injury Research Center, Department of Biostatistic and Epidemiology,Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Dolatkhah', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pishgahi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Pirani', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.009']
135,32299513,A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma.,"Rituximab in combination with chemotherapy has shown efficacy in patients with diffuse large B-cell lymphoma (DLBCL) for more than 15 years. HLX01 was developed as the rituximab biosimilar following a stepwise approach to demonstrate biosimilarity in analytical, pre-clinical, and clinical investigations to reference rituximab. With demonstrated pharmacokinetic similarity, a phase 3 multi-center, randomized, parallel, double-blind study (HLX01-NHL03) was subsequently conducted to compare efficacy and safety between HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) and reference rituximab plus CHOP (R-CHOP) in a total of 407 treatment-naïve, CD20-positive DLBCL patients aged 18-80 years. The primary efficacy endpoint was best overall response rate (ORR) within six cycles of treatment in the per-protocol set (PPS). Secondary endpoints included 1-year efficacy outcomes, safety, and immunogenicity profile. The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], - 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%. The safety profile was comparable between the treatment groups, with a similar overall incidence of treatment-emergent adverse events (H-CHOP 99.5%, R-CHOP 99.0%, p = 1.000) and serious adverse events (H-CHOP 34.0%, R-CHOP 32.5%, p = 0.752). This study established bioequivalence in efficacy and safety between HLX01 and reference rituximab. The trial was registered at http://www.chinadrugtrials.org.cn on 26 August 2015 [#CTR20150583].",2020,"The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], - 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%.","['patients with diffuse large B-cell lymphoma (DLBCL) for more than 15\u2009years', 'patients with diffuse large B-cell lymphoma', 'a total of 407 treatment-naïve, CD20-positive DLBCL patients aged 18-80\u2009years']","['HLX01 and reference rituximab', 'rituximab biosimilar HLX01', 'chemotherapy', 'HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) and reference rituximab plus CHOP (R-CHOP', 'HLX01', 'Rituximab']","['serious adverse events', '1-year efficacy outcomes, safety, and immunogenicity profile', 'efficacy and safety', 'safety profile', 'overall response rate (ORR', 'ORRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.152564,"The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], - 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%.","[{'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. syuankai@cicams.ac.cn.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Daping Hospital, Third Affiliated Hospital of the Army Medical University, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Second Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research, Nanjing, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Huilai', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Cancer Center of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Jianda', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhengming', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Soochow, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': ""The 307th Hospital of Chinese People's Liberation Army, Beijing, China.""}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Tianjin People's Hospital, Tianjin, China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Shanghai Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Jinan Central Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Tangdu Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': ""Guo'an"", 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Pingyong', 'Initials': 'P', 'LastName': 'Yi', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xielan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chaoming', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chai', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Luk', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00871-9']
136,32302308,Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial.,"BACKGROUND


Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia.
METHODS AND FINDINGS


This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (-4.5, 95% CI -6.9 to -2.2, p < 0.001, Cohen's d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes.
CONCLUSIONS


Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention.
TRIAL REGISTRATION


The trial was registered on ClinicalTrials.gov (NCT02790827).",2020,"Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49).","[""a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia"", 'majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age', '123 couples', 'Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use', 'intimate partner violence and hazardous alcohol use in Zambia (VATU']","['TAU', 'Common Elements Treatment Approach (CETA', 'CETA', 'TAU-Plus']","['IPV', 'Mean reduction in IPV (via SVAWS subscale score', 'mean reduction in AUDIT score', 'Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C2015861', 'cui_str': 'Multiple birth'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}]",123.0,0.188015,"Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49).","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Flor', 'Initials': 'F', 'LastName': 'Melendez', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Zambia, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Research and Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mayeya', 'Affiliation': 'Ministry of Health-Zambia, Chainama Hills College Hospital, Lusaka, Zambia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Simenda', 'Affiliation': 'Chainama Hills College Hospital, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003056']
137,32047155,First-in-human robotic supermicrosurgery using a dedicated microsurgical robot for treating breast cancer-related lymphedema: a randomized pilot trial.,"Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation. Supermicrosurgery is limited by the precision and dexterity of the surgeon's hands. Robot assistance can help overcome these human limitations, thereby enabling a breakthrough in supermicrosurgery. We report the first-in-human study of robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform. A prospective randomized pilot study is conducted comparing robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA) in treating breast cancer-related lymphedema. We evaluate patient outcome at 1 and 3 months post surgery, duration of the surgery, and quality of the anastomosis. At 3 months, patient outcome improves. Furthermore, a steep decline in duration of time required to complete the anastomosis is observed in the robot-assisted group (33-16 min). Here, we report the feasibility of robot-assisted supermicrosurgical anastomosis in LVA, indicating promising results for the future of reconstructive supermicrosurgery.",2020,Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation.,"['breast cancer-related lymphedema', 'treating breast cancer-related lymphedema']","['robot-assisted supermicrosurgical anastomosis', 'First-in-human robotic supermicrosurgery using a dedicated microsurgical robot', 'robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform', 'robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA']","['duration of the surgery, and quality of the anastomosis', 'duration of time required to complete the anastomosis']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0450432', 'cui_str': 'Venous anastomosis (attribute)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0245986,Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation.,"[{'ForeName': 'Tom J M', 'Initials': 'TJM', 'LastName': 'van Mulken', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Rutger M', 'Initials': 'RM', 'LastName': 'Schols', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. rutger.schols@mumc.nl.'}, {'ForeName': 'Andrea M J', 'Initials': 'AMJ', 'LastName': 'Scharmga', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Cau', 'Affiliation': 'Department of Medical Robotic Technologies, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Ferry B F', 'Initials': 'FBF', 'LastName': 'Schoenmakers', 'Affiliation': 'Department of Medical Robotic Technologies, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Shan S', 'Initials': 'SS', 'LastName': 'Qiu', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'René R W J', 'Initials': 'RRWJ', 'LastName': 'van der Hulst', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-019-14188-w']
138,32084347,Therapeutic Effects of Exercise Training on Elderly Patients With Dementia: A Randomized Controlled Trial.,"OBJECTIVE


To investigate whether strength or aerobic training can offer significantly more benefits with regarding the activities of daily living of elderly patients with dementia as well as to determine the effects of exercise on cognition, depression, and biochemical markers.
DESIGN


Single-blind randomized controlled trial.
SETTING


A nursing home for veterans.
PARTICIPANTS


A volunteer sample of participants (N=80) whose scores on the Mini-Mental State Examination were between 15 and 26 were included. Because of cardiopulmonary or orthopedic conditions that prohibit exercise training, along with any cognitive problems that may impede answering the contents of our questionnaires, 11 participants were excluded. During the exercise training period, 8 participants voluntarily dropped out of the study.
INTERVENTIONS


The participants were randomly assigned to perform either strength or aerobic training for a total of 4 weeks.
MAIN OUTCOME MEASURES


The main outcome measure was the Barthel Index. Other outcome measures included the Mini-Mental State Examination, Montreal Cognitive Assessment, Geriatric Depression Scale, plasma monocyte chemotactic protein-1 levels, insulin-like growth factor-1 levels, and serum brain-derived neurotrophic factor levels.
RESULTS


After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group. For the patients who had received aerobic training, their serum brain-derived neurotrophic factor also improved significantly. However, the degree of improvement regarding these outcome measures did not achieve significant statistical difference between the 2 groups.
CONCLUSIONS


Through our study, an intensive 4-week exercise program, whether it be strength or aerobic training, is evidenced to bring significant benefits to elderly patients with dementia, while the serum brain-derived neurotrophic factor was additionally improved through aerobic training.",2020,"After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group.","['Elderly Patients with Dementia', 'elderly patients with dementia', 'A volunteer sample of 80 participants whose scores on the Mini-Mental State Examination were between 15 and 26 were included']","['Exercise Training', 'aerobic training', 'prohibit exercise training', 'strength or aerobic training']","['Mini-Mental State Examination, Montreal Cognitive Assessment, Geriatric Depression Scale, plasma monocyte chemotactic protein-1 levels, insulin-like growth factor-1 levels, and serum brain-derived neurotrophic factor levels', 'serum brain-derived neurotrophic factor', ""patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels"", 'Barthel Index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3496286'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",11.0,0.146852,"After completion of the program, we discovered a significant improvement in the patients' Barthel Index, Mini-Mental State Examination, Montreal Cognitive Assessment, and plasma monocyte chemotactic protein-1 levels in the strength-training group.","[{'ForeName': 'I-Ting', 'Initials': 'IT', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shih-Yi', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shin-Tsu', 'Initials': 'ST', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan; Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taipei, Taiwan; School of Medicine, National Defense Medical Center, Taipei, Taiwan; School of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yuan-Yang', 'Initials': 'YY', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, Taichung, Taiwan; Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: rifampin@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.012']
139,32313854,"Application of Frequent, Spaced Multiple-choice Questions as an Educational Tool in the Pediatric Emergency Department.","Objectives


The objective was to assess the feasibility of using spaced multiple-choice questions (MCQs) to teach residents during their pediatric emergency department (PED) rotation and determine whether this teaching improves knowledge retention about pediatric rashes.
Methods


Residents rotating in the PED from four sites were randomized to four groups: pretest and intervention, pretest and no intervention, no pretest and intervention, and no pretest and no intervention. Residents in intervention groups were automatically e-mailed quizlets with two MCQs every other day over 4 weeks (20 questions total) via an automated e-mail service with answers e-mailed 2 days later. Retention of knowledge was assessed 70 days after enrollment with a posttest of 20 unique, content-matched questions.
Results


Between August 2015 and November 2016, a total 234 residents were enrolled. The completion rate of individual quizlets ranged from 93% on the first and 76% on the 10th quizlet. Sixty-six residents (55%) completed all 10 quizlets. One-hundred seventy-three residents (74%) completed the posttest. There was no difference in posttest scores between residents who received a pretest (61.0% ± 14.5%) and those who did not (64.6% ± 14.0%; mean difference = -3.7, 95% confidence interval [CI] = -8.0 to 0. 6) nor between residents who received the intervention (64.5% ± 13.3%) and those who did not receive the intervention (61.2% ± 15.2%; mean difference = 3.2, 95% CI = -1.1 to 7.5). For those who received a pretest, scores improved from the pretest to the posttest (46.4% vs. 60.1%, respectively; 95% CI = 9.7 to 19.5).
Conclusion


Providing spaced MCQs every other day to residents rotating through the PED is a feasible teaching tool with a high participation rate. There was no difference in posttest scores regardless of pretest or intervention. Repeated exposure to the same MCQs and an increase in the number of questions sent to residents may increase the impact of this educational strategy.",2020,There was no difference in posttest scores between residents who received a pretest (61.0% ± 14.5%) and those who did not (64.6% ± 14.0%; mean difference =,"['Methods\n\n\nResidents rotating in the PED from four sites were randomized to four groups', 'Sixty-six residents (55%) completed all 10 quizlets', 'teach residents during their pediatric emergency department (PED) rotation', 'One-hundred seventy-three residents (74%) completed the posttest', 'Results\n\n\nBetween August 2015 and November 2016, a total 234 residents were enrolled']","['pretest and intervention, pretest and no intervention, no pretest and intervention, and no pretest and no intervention', 'spaced multiple-choice questions (MCQs']","['posttest scores', 'Retention of knowledge', 'completion rate of individual quizlets']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",234.0,0.0465456,There was no difference in posttest scores between residents who received a pretest (61.0% ± 14.5%) and those who did not (64.6% ± 14.0%; mean difference =,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Rustici', 'Affiliation': 'Department of Pediatrics Denver Health Medical Center Denver CO.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine UT Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Dorney', 'Affiliation': ""Department of Emergency Medicine Boston Children's Hospital Boston MA.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Nagler', 'Affiliation': ""Department of Emergency Medicine Boston Children's Hospital Boston MA.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jamil Madati', 'Affiliation': ""Department of Emergency Medicine Children's National Medical Center Washington DC.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ziegler', 'Affiliation': 'Department of Pediatrics Denver Health Medical Center Denver CO.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Roosevelt', 'Affiliation': 'Department of Pediatrics Denver Health Medical Center Denver CO.'}]",AEM education and training,['10.1002/aet2.10366']
140,32243036,Uric acid predicts long-term cardiovascular risk in type 2 diabetes but does not mediate the benefits of fenofibrate: The FIELD study.,"AIM


To explore the relationship between baseline uric acid (UA) levels and long-term cardiovascular events in adults with type 2 diabetes (T2D) and to determine whether the cardioprotective effects of fenofibrate are partly mediated through its UA-lowering effects.
METHODS


Data from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial were utilized, comprising 9795 adults with T2D randomly allocated to treatment with fenofibrate or matching placebo. Plasma UA was measured before and after a 6-week, active fenofibrate run-in phase in all participants. Cox proportional hazards models were used to explore the relationships between baseline UA, pre-to-post run-in reductions in UA and long-term cardiovascular outcomes.
RESULTS


Mean baseline plasma UA was 0.33 mmol/L (SD 0.08). Baseline UA was a significant predictor of long-term cardiovascular events, with every 0.1 mmol/L higher UA conferring a 21% increase in event rate (HR 1.21, 95% CI 1.13-1.29, P < .001). This remained significant after adjustment for treatment allocation, cardiovascular risk factors and renal function. The extent of UA reduction during fenofibrate run-in was also a significant predictor of long-term cardiovascular events, with every 0.1 mmol/L greater reduction conferring a 14% lower long-term risk (HR 0.86, 95% CI 0.76-0.97, P = .015). This effect was not modified by treatment allocation (P interaction  = .77).
CONCLUSIONS


UA is a strong independent predictor of long-term cardiovascular risk in adults with T2D. Although greater reduction in UA on fenofibrate is predictive of lower cardiovascular risk, this does not appear to mediate the cardioprotective effects of fenofibrate.",2020,"The extent of UA reduction during fenofibrate run-in was also significant predictor of long-term cardiovascular events, with every 0.1 mmol/L greater reduction conferring a 14% lower long-term risk (HR 0.86, 95% CI 0.76-0.97, p = 0.015).","['9795 adults with type 2 diabetes (T2D) randomly allocated to treatment with', 'adults with T2D']","['Fenofibrate', 'fenofibrate', 'Fenofibrate Intervention', 'fenofibrate or matching placebo']","['cardiovascular risk factors, and renal function', 'Plasma UA', 'long-term cardiovascular events', 'event rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",9795.0,0.147303,"The extent of UA reduction during fenofibrate run-in was also significant predictor of long-term cardiovascular events, with every 0.1 mmol/L greater reduction conferring a 14% lower long-term risk (HR 0.86, 95% CI 0.76-0.97, p = 0.015).","[{'ForeName': 'Jacob Y', 'Initials': 'JY', 'LastName': 'Cao', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Waldman', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connell"", 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Sullivan', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Scott', 'Affiliation': 'Lipid & Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Aryal', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Marschner', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marja-Riitta', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': 'Heart and Lung Centre, Cardiovascular Research Unit, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Simes', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'McGill', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14046']
141,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND


The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults.
METHODS


This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10 7  plaque-forming unit (PFU; low-dose group) or 1 × 10 8  PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime-boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1-3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960-0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group.
INTERPRETATION


Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.
FUNDING


German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7  plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8  PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6']
142,32240186,"Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia.","BACKGROUND


Youth-led strategies remain untested in clinic-based programs to improve viral suppression (VS) and reduce stigma among HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa. In response, Project YES! placed paid HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children's Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings).
METHODS


A randomized controlled trial was conducted from December 2017 to February 2019. Consecutively recruited 15 to 24-year-olds were randomly assigned to an intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm. Survey data and blood samples were collected at baseline and at the six-month midline. Generalized estimating equation models evaluated the effect of study arm over time on VS, antiretroviral treatment (ART) adherence gap, and internalized stigma.
RESULTS


Out of 276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136). VS significantly improved in both arms (I:63.5% to 73.0%; C:63.7% to 71.3.0%) [OR:1.49, 95% CI:1.08, 2.07]. In a stratified analysis intervention (I:37.5% to 70.5%) versus the comparison (C:60.3% to 59.4%) participants from the pediatric clinic experienced a relative increase in the odds of VS by a factor of 4.7 [interaction term OR:4.66, 95% CI:1.84, 11.78]. There was no evidence of a study arm difference in VS among AYA in adult clinics, or in ART adherence gaps across clinics. Internalized stigma significantly reduced by a factor of 0.39 [interaction term OR:0.39, 95% CI:0.21,0.73] in the intervention (50.4% to 25.4%) relative to the comparison arm (45.2% to 39.7%).
CONCLUSIONS


Project YES! engaged AYA, improving VS in the pediatric clinic and internalized stigma in the pediatric and adult clinics. Further research is needed to understand the intersection of VS and internalized stigma among AYA attending adult HIV clinics.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04115813.",2020,Internalized stigma significantly reduced by a factor of 0.39,"['Youth Engaging for Success', 'HIV-positive youth (15-24 years) in Ndola, Zambia', 'December 2017 to February 2019', ""HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children's Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings"", '276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136', 'HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa', 'Consecutively recruited 15 to 24-year-olds']","['intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm', 'clinic-based peer mentoring program']","['viral suppression, adherence and internalized stigma', 'Internalized stigma']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",276.0,0.223527,Internalized stigma significantly reduced by a factor of 0.39,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Denison', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Burke', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Miti', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Frimpong', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Merrill', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Abrams', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Mwansa', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}]",PloS one,['10.1371/journal.pone.0230703']
143,31210635,Tinnitus Sound Therapy Trial Shows Effectiveness for Those with Tinnitus.,"BACKGROUND


It is well accepted among clinicians that maskers and hearing aids combined with counseling are generally helpful to tinnitus patients, but there are few controlled studies exploring the efficacy of maskers alone to decrease the prominence of tinnitus.
PURPOSE


We investigated the benefit of maskers for patients with chronic, bothersome tinnitus.
RESEARCH DESIGN


Crossover single-participant design, where each participant served as their own control.
STUDY SAMPLE


18 adults with subjective, nonpulsatile, sensorineural tinnitus.
INTERVENTION


Participants participated in two six-week trials: one with sound therapy and one without. No counseling was provided in either group. Masking devices were fit with sounds intended to reduce the tinnitus prominence.
DATA COLLECTION AND ANALYSIS


Participants rated tinnitus loudness, tinnitus annoyance, and acceptability of the background sounds using a numeric 0-100 interval scale and completed the Tinnitus Primary Functions Questionnaire (TPFQ).
RESULTS


Three participants dropped out. On the total score of the TPFQ, 5 of 15 remaining participants (33%) showed a benefit. Using a derived score based on functions showing a handicap before the study, maskers benefit was observed in the areas of sleep (five of nine), hearing (three of eight), thoughts and emotions (three of four), and concentration (four of eight). The TPFQ and annoyance data complemented each other well.
CONCLUSIONS


This study demonstrates the benefit of partial masking, encouraging patients to seek help from audiologists interested in providing support for tinnitus patients.",2020,"On the total score of the TPFQ, 5 of 15 remaining participants (33%) showed a benefit.","['tinnitus patients', '18 adults with subjective, nonpulsatile, sensorineural tinnitus', 'patients with chronic, bothersome tinnitus']",[],"['tinnitus loudness, tinnitus annoyance, and acceptability of the background sounds using a numeric 0-100 interval scale and completed the Tinnitus Primary Functions Questionnaire (TPFQ']","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",[],"[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0222045'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",18.0,0.0900412,"On the total score of the TPFQ, 5 of 15 remaining participants (33%) showed a benefit.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Tyler', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Perreau', 'Affiliation': 'Department of Communication Sciences and Disorders, Augustana College, Rock Island, IL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powers', 'Affiliation': 'Sivantos, Inc., Piscataway, NJ.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Watts', 'Affiliation': 'Department of Communication Sciences and Disorders, Augustana College, Rock Island, IL.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Ji', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Mancini', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18027']
144,32302347,"Clinical impact of melatonin on breast cancer patients undergoing chemotherapy; effects on cognition, sleep and depressive symptoms: A randomized, double-blind, placebo-controlled trial.","This randomized, double-blinded, placebo-controlled trial tested the hypothesis that 20mg of melatonin before and during the first cycle of adjuvant chemotherapy for breast cancer (ACBC) reduced the side effects associated with cognitive impairment. We evaluated the effects of melatonin on cognition, depressive symptoms and sleep quality, and whether these effects were related to serum levels of Brain Derived Neurotrophic Factor (BDNF) and its receptor, tropomyosin kinase B (TrkB). Thirty-six women were randomly assigned to receive melatonin or placebo for 10 days. To evaluate cognitive performance, we used the Trail-Making-Test Parts A and B (A-B), Rey Auditory-Verbal Learning Test (RAVLT), Controlled Oral Word Association Test (COWAT) and an inhibitory task type Go / No-Go. Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT. The TMT-A-B(A-B) were negatively correlated with baseline levels of TrkB and BDNF, respectively. At the end of treatment, changes in TrkB and BDNF were inversely associated with depressive symptoms and sleep quality, but not with the TMT scores. These results suggest a neuroprotective effect of melatonin to counteract the adverse effects of ACBC on cognitive function, sleep quality and depressive symptoms.",2020,"Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT.","['Thirty-six women', 'breast cancer (ACBC', 'breast cancer patients undergoing']","['melatonin or placebo', 'Trail-Making-Test Parts A and B (A-B), Rey Auditory-Verbal Learning Test (RAVLT), Controlled Oral Word Association Test (COWAT) and an inhibitory task type', 'placebo', 'chemotherapy', 'melatonin']","['cognitive function, sleep quality and depressive symptoms', 'executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency', 'cognition, depressive symptoms and sleep quality', 'depressive symptoms and sleep quality', 'changes in TrkB and BDNF', 'cognition, sleep and depressive symptoms', 'serum levels of Brain Derived Neurotrophic Factor (BDNF) and its receptor, tropomyosin kinase B (TrkB']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0077397', 'cui_str': 'Tropomyosin kinase'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",36.0,0.466551,"Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT.","[{'ForeName': 'Ana Claudia Souza', 'Initials': 'ACS', 'LastName': 'Palmer', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maxciel', 'Initials': 'M', 'LastName': 'Zortea', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Souza', 'Affiliation': 'La Salle University Center, Canoas, RS, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jorge Villanova', 'Initials': 'JV', 'LastName': 'Biazús', 'Affiliation': 'Division of Breast Surgery, Hospital de Clinicas de Porto Alegre (HCPA), Post-graduate Program in Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Iraci L S', 'Initials': 'ILS', 'LastName': 'Torres', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}]",PloS one,['10.1371/journal.pone.0231379']
145,32207694,Using Mobile Health Tools to Engage Rural Underserved Individuals in a Diabetes Education Program in South Texas: Feasibility Study.,"BACKGROUND


Access to diabetes education and resources for diabetes self-management is limited in rural communities, despite higher rates of diabetes in rural populations compared with urban populations. Technology and mobile health (mHealth) interventions can reduce barriers and improve access to diabetes education in rural communities. Screening, Brief Intervention, and Referral to Treatment (SBIRT) and financial incentives can be used with mHealth interventions to increase the uptake of diabetes education; however, studies have not examined their combined use for diabetes self-management in rural settings.
OBJECTIVE


This two-phase Stage 1 feasibility study aimed to use a mixed methods design to examine the feasibility and acceptability of an mHealth diabetes education program combining SBIRT and financial incentives to engage rural individuals.
METHODS


In Phase 1, we aimed to develop, adapt, and refine the intervention protocol. In Phase 2, a 3-month quasi-experimental study was conducted with individuals from 2 rural communities in South Texas. Study participants were individuals who attended free diabetes screening events in their community. Those with low or medium risk received health education material, whereas those with high risk or those with a previous diagnosis of diabetes participated in motivational interviewing and enrolled in the 6-week mHealth Diabetes Self-Management Education Program under either an unconditional or aversion incentive contract. The participants returned for a 3-month follow-up. Feasibility and acceptability of the intervention were determined by the rate of participant recruitment and retention, the fidelity of program delivery and compliance, and the participant's satisfaction with the intervention program.
RESULTS


Of the 98 screened rural community members in South Texas, 72 individuals met the study eligibility and 62 individuals agreed to enroll in the study. The sample was predominately female and Hispanic, with an average age of 52.6 years. The feedback from study participants indicated high levels of satisfaction with the mHealth diabetes education program. In the poststudy survey, the participants reported high levels of confidence to continue lifestyle modifications, that is, weight loss, physical activity, and diet. The retention rate was 50% at the 3-month follow-up. Participation in the intervention was high at the beginning and dissipated in the later weeks regardless of the incentive contract type. Positive changes were observed in weight (mean -2.64, SD 6.01; P<.05) and glycemic control index (-.30; P<.05) in all participants from baseline to follow-up.
CONCLUSIONS


The finding showed strong feasibility and acceptability of study recruitment and enrollment. The participants' participation and retention were reasonable given the unforeseen events that impacted the study communities during the study period. Combining mHealth with SBIRT has the potential to reach individuals with need to participate in diabetes education in rural communities.",2020,Technology and mobile health (mHealth) interventions can reduce barriers and improve access to diabetes education in rural communities.,"['Engage Rural Underserved Individuals in a Diabetes Education Program in South Texas', 'Study participants were individuals who attended free diabetes screening events in their community', '72 individuals met the study eligibility and 62 individuals agreed to enroll in the study', 'rural communities', '98 screened rural community members in South Texas', 'engage rural individuals', 'The sample was predominately female and Hispanic, with an average age of 52.6 years', 'individuals from 2 rural communities in South Texas']","['Technology and mobile health (mHealth) interventions', 'motivational interviewing and enrolled in the 6-week mHealth Diabetes Self-Management Education Program under either an unconditional or aversion incentive contract']","['Feasibility and acceptability', 'retention rate', 'glycemic control index', 'weight (mean', 'weight loss, physical activity, and diet']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",,0.0321933,Technology and mobile health (mHealth) interventions can reduce barriers and improve access to diabetes education in rural communities.,"[{'ForeName': 'Zenong', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Department of Public Health, College of Health, Community and Policy, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Lesser', 'Affiliation': 'School of Nursing, The University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Kristi A', 'Initials': 'KA', 'LastName': 'Paiva', 'Affiliation': 'School of Nursing, The University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Zapata', 'Affiliation': 'School of Nursing, The University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moreno-Vasquez', 'Affiliation': 'School of Nursing, The University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Grigsby', 'Affiliation': 'Department of Public Health, College of Health, Community and Policy, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Stacy R', 'Initials': 'SR', 'LastName': 'Ryan-Pettes', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, TX, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parra-Medina', 'Affiliation': 'Department of Mexican American and Latina/o Studies, The University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Estrada', 'Affiliation': 'Department of Public Health, College of Health, Community and Policy, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Shiyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Public Health, College of Health, Community and Policy, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/16683']
146,32004517,Chronic Pain Self-Management Support With Pain Science Education and Exercise (COMMENCE) for People With Chronic Pain and Multiple Comorbidities: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effectiveness of chronic pain self-management support with pain science education and exercise (COMMENCE) on improving function, pain interference, work status, pain intensity, fatigue, psychological factors associated with pain, health care visits, satisfaction, and perceived change compared with usual care.
DESIGN


Parallel group randomized controlled trial with 1- and 12-week follow-ups.
SETTING


Community health center.
PARTICIPANTS


Adults (N=102) with chronic noncancer pain referred for self-management support. Eighty of 102 participants completed 12-week follow-up assessments. No participants withdrew with adverse events.
INTERVENTIONS


Participants were randomized to COMMENCE or usual care.
MAIN OUTCOME MEASURES


Primary: Function measured using the Short Musculoskeletal Function Assessment-Dysfunction Index. Secondary: Short Musculoskeletal Function Assessment-Bother Index, Patient Reported Outcomes Measurement Information System pain interference, work status, numeric pain, and fatigue rating scales, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Scale, Neurophysiology of Pain Questionnaire, number of health care visits, satisfaction, and global rating of change.
RESULTS


COMMENCE resulted in greater improvements in function (mean difference [MD] at 12-wk follow-up=-8.0; 95% CI, -14.7 to -1.3), bother with functional difficulties (MD, -12.0; 95% CI, -20.8 to -3.2), pain intensity (MD, -1.0; 95% CI, -2.1 to -0.1), catastrophizing (MD , -8.2; 95% CI, -14.5 to -2.0), self-efficacy (MD, 7.0; 95% CI, 0.8-13.2), knowledge (MD, 2.8; 95% CI, 1.6-3.9), satisfaction (MD, 1.2; 95% CI, 0.7-1.8), and perceived change (MD, 1.4; 95% CI, 0.8-2.1). There were no significant between-group differences in pain interference, work, fatigue, depressive symptoms, or health care visits.
CONCLUSION


COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change but not pain interference, work status, fatigue, depressive symptoms, or health care visits.",2020,"CONCLUSION


COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits.","['Adults (n=102) with chronic non-cancer pain referred for self-management support', 'Community health centre', 'people with chronic pain and multiple comorbidities', 'Eighty of 102 participants completed 12-week follow-up assessments']","['pain science EducatioN and exerCisE (COMMENCE', 'pain science education and exercise']","['self-efficacy', 'pain intensity', 'Short Musculoskeletal Function Assessment (SMFA) - Dysfunction Index', 'bother with functional difficulties', 'pain interference, work, fatigue, depressive symptoms, or healthcare visits', 'improving function, pain interference, work status, pain intensity, fatigue, psychological factors associated with pain, health care visits, satisfaction, and perceived change compared to usual care', 'function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits', 'SMFA bother index, PROMIS pain interference, work status, numeric pain and fatigue rating scales, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Scale, Neurophysiology of Pain Questionnaire, number of healthcare visits, satisfaction, and global rating of change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal Physiological Concepts'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",102.0,0.193187,"CONCLUSION


COMMENCE is more effective than usual care at improving function, pain, catastrophic thinking, self-efficacy, pain knowledge, satisfaction, and perceived change, but not pain interference, work status, fatigue, depressive symptoms, or health care visits.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada. Electronic address: jordan.miller@queensu.ca.'}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Walton', 'Affiliation': 'School of Physical Therapy, Western University, London, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.016']
147,32320401,"Febuxostat does not delay progression of carotid atherosclerosis in patients with asymptomatic hyperuricemia: A randomized, controlled trial.","BACKGROUND


An elevated level of serum uric acid (SUA) is associated with an increased risk of cardiovascular disease. Pharmacological intervention with urate-lowering agents, such as the conventional purine analogue xanthine oxidase (XO) inhibitor, allopurinol, has been used widely for a long period of time in clinical practice to reduce SUA levels. Febuxostat, a novel non-purine selective inhibitor of XO, has higher potency for inhibition of XO activity and greater urate-lowering efficacy than conventional allopurinol. However, clinical evidence regarding the effects of febuxostat on atherosclerosis is lacking. The purpose of the study was to test whether treatment with febuxostat delays carotid intima-media thickness (IMT) progression in patients with asymptomatic hyperuricemia.
METHODS AND FINDINGS


The study was a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial undertaken at 48 sites throughout Japan between May 2014 and August 2018. Adults with both asymptomatic hyperuricemia (SUA >7.0 mg/dL) and maximum IMT of the common carotid artery (CCA) ≥1.1 mm at screening were allocated equally using a central web system to receive either dose-titrated febuxostat (10-60 mg daily) or as a control-arm, non-pharmacological lifestyle modification for hyperuricemia, such as a healthy diet and exercise therapy. Of the 514 enrolled participants, 31 were excluded from the analysis, with the remaining 483 people (mean age 69.1 years [standard deviation 10.4 years], female 19.7%) included in the primary analysis (febuxostat group, 239; control group, 244), based on a modified intention-to-treat principal. The carotid IMT images were recorded by a single sonographer at each site and read in a treatment-blinded manner by a single analyzer at a central core laboratory. The primary endpoint was the percentage change from baseline to 24 months in mean IMT of the CCA, determined by analysis of covariance using the allocation adjustment factors (age, gender, history of type 2 diabetes, baseline SUA, and baseline maximum IMT of the CCA) as the covariates. Key secondary endpoints included changes in other carotid ultrasonographic parameters and SUA and the incidence of clinical events. The mean values (± standard deviation) of CCA-IMT were 0.825 mm ± 0.173 mm in the febuxostat group and 0.832 mm ± 0.175 mm in the control group (mean between-group difference [febuxostat - control], -0.007 mm [95% confidence interval (CI) -0.039 mm to 0.024 mm; P = 0.65]) at baseline; 0.832 mm ± 0.182 mm in the febuxostat group and 0.848 mm ± 0.176 mm in the control group (mean between-group difference, -0.016 mm [95% CI -0.051 mm to 0.019 mm; P = 0.37]) at 24 months. Compared with the control group, febuxostat had no significant effect on the primary endpoint (mean percentage change 1.2% [95% CI -0.6% to 3.0%] in the febuxostat group (n = 207) versus 1.4% [95% CI -0.5% to 3.3%] in the control group (n = 193); mean between-group difference, -0.2% [95% CI -2.3% to 1.9%; P = 0.83]). Febuxostat also had no effect on the other carotid ultrasonographic parameters. The mean baseline values of SUA were comparable between the two groups (febuxostat, 7.76 mg/dL ± 0.98 mg/dL versus control, 7.73 mg/dL ± 1.04 mg/dL; mean between-group difference, 0.03 mg/dL [95% CI -0.15 mg/dL to 0.21 mg/dL; P = 0.75]). The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/dL [95% CI -2.86 mg/dL to -2.38 mg/dL; P < 0.001]). Episodes of gout arthritis occurred only in the control group (4 patients [1.6%]). There were three deaths in the febuxostat group and seven in the control group during follow-up. A limitation of the study was the study design, as it was not a placebo-controlled trial, had a relatively small sample size and a short intervention period, and only enrolled Japanese patients with asymptomatic hyperuricemia.
CONCLUSIONS


In Japanese patients with asymptomatic hyperuricemia, 24 months of febuxostat treatment did not delay carotid atherosclerosis progression, compared with non-pharmacological care. These findings do not support the use of febuxostat for delaying carotid atherosclerosis in this population.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trial Registry UMIN000012911.",2020,"The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/","['Adults with both asymptomatic hyperuricemia (SUA >7.0 mg/dL) and maximum IMT of the common carotid artery (CCA) ≥1.1 mm at screening', 'enrolled Japanese patients with asymptomatic hyperuricemia', 'Japanese patients with asymptomatic hyperuricemia, 24 months of', '48 sites throughout Japan between May 2014 and August 2018', '514 enrolled participants, 31 were excluded from the analysis, with the remaining 483 people (mean age 69.1 years [standard deviation 10.4 years], female 19.7%) included in the primary analysis (febuxostat group, 239; control group, 244), based on a modified intention-to-treat principal', 'patients with asymptomatic hyperuricemia']","['febuxostat delays carotid intima-media thickness (IMT) progression', 'Febuxostat', 'febuxostat', 'Pharmacological intervention with urate-lowering agents, such as the conventional purine analogue xanthine oxidase (XO) inhibitor, allopurinol', 'placebo', 'febuxostat (10-60 mg daily) or as a control-arm, non-pharmacological lifestyle modification for hyperuricemia, such as a healthy diet and exercise therapy', 'dL', 'conventional allopurinol']","['carotid ultrasonographic parameters', 'delay carotid atherosclerosis progression', 'changes in other carotid ultrasonographic parameters and SUA and the incidence of clinical events', 'carotid IMT images', 'mean values (± standard deviation) of CCA-IMT', 'mean value of SUA', 'Episodes of gout arthritis', 'percentage change from baseline to 24 months in mean IMT of the CCA, determined by analysis of covariance using the allocation adjustment factors (age, gender, history of type 2 diabetes, baseline SUA, and baseline maximum IMT of the CCA', 'mean baseline values of SUA', 'carotid atherosclerosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348944', 'cui_str': 'Hyperuricemia without signs of inflammatory arthritis and tophaceous disease'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1268902', 'cui_str': 'Purine analog'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0003868', 'cui_str': 'Gouty arthropathy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",514.0,0.180376,"The mean value of SUA at 24 months was significantly lower in the febuxostat group than in the control group (febuxostat, 4.66 mg/dL ± 1.27 mg/dL versus control, 7.28 mg/dL ± 1.27 mg/dL; mean between-group difference, -2.62 mg/","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Ishizaka', 'Affiliation': 'Department of Cardiology, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Cardiology, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sezai', 'Affiliation': 'The Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Eguchi', 'Affiliation': 'Department of Internal Medicine, Hanyu General Hospital, Hanyu, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Clinical Research, National Hospital Organization, Tochigi Medical Center, Utsunomiya, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University, Mibu, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Kimitsu Chuo Hospital, Kisarazu, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishizu', 'Affiliation': 'Department of Clinical Laboratory Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Ohishi', 'Affiliation': 'Department of Cardiovascular Medical and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Oyama', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003095']
148,32320457,Sexual network distribution of HIV self-testing kits: Findings from the process evaluation of an intervention for men who have sex with men in China.,"BACKGROUND


The World Health Organization has recommended HIV self-testing (HIVST) as an alternative testing strategy given the limitations of facility-based testing. While the benefits of HIV self-testing have been demonstrated at the individual level among men who have sex with men (MSM), limited data exist on if this testing approach can be effectively diffused through individuals' social or sexual networks. The objectives of this study were to examine patterns and correlates of HIVST distribution within Chinese MSM's sexual networks.
METHODS


Data used for this analysis was a part of the process evaluation of an HIVST intervention trial among MSM in Nanjing, China. Between May and October 2017, we enrolled 400 men into the trial. Participants assigned to the intervention group (N = 200) were given three HIVST kits at baseline and could request more during the follow-up periods. We incorporated measures for process evaluation in the self-administered online follow-up surveys. This analysis reported findings from the three-month follow-up survey in the intervention group. Frequencies and percentages were used to describe characteristics of participants who distributed kits to their sexual partners as well as patterns of distribution. Multivariable logistic regression was conducted to identify independent correlates of participants who distributed the kits.
RESULTS


Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners. About half of distributors (51.4%) gave one HIVST kit to their sexual partners while 15.3% distributed 3 or more. Over half gave these kits (58.3%) to primary sexual partners while 27.8% reported giving the kits to both primary and casual partners. About half (54.2%) of distributors used the kits together with their partners. Compared to participants who had an HIV test in the past six months, those who tested over six months ago or never tested had significantly lower odds of distributing the kits (AOR = 0.484, 95% CI: 0.250-0.983, p = 0.032). Compared to those who had not used the kits themselves, participants who did had significantly higher odds of distributing the kits (AOR = 3.345, 95% CI: 1.488-7.517, p = 0.003). Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
CONCLUSION


Our study demonstrated that a sexual network-based approach to distributing HIVST among Chinese MSM is feasible and can be a promising strategy to improve the effectiveness of HIVST programs including its reach to untested men. Such approach should be complimented by intervention components that enhance HIV testing efficacy and improve experiences of HIVST.",2020,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","['men who have sex with men (MSM', 'men who have sex with men in China', '400 men into the trial', 'Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners']",['HIV self-testing kits'],['HIV testing efficacy'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",400.0,0.0417201,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Gengfeng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Institute of Parasitic Diseases, Wuxi, Jiangsu, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, New Jersey, United States of America.'}]",PloS one,['10.1371/journal.pone.0232094']
149,29562851,Are ADHD Screeners Safe to Use?,"Objective:  To investigate whether administration of a common ADHD screener followed by generic feedback would affect college students' subsequent symptom reports and cognitive performance.  Method:  Participants were 157 college students randomly assigned to an experimental group-which completed the World Health Organization Adult ADHD Self-Report Scale screener and received standard generic feedback-or a control group. All participants then completed a battery of cognitive tasks and a long-form symptom rating scale.  Results:  The experimental and control groups did not differ significantly in terms of their subsequent symptom reports or their performance on any cognitive tasks. These null results remained after considering possibilities such as unequal group variances and interactions between screening effects and gender.  Conclusion:  When administered judiciously alongside generic feedback in a group setting, this common ADHD screener does not appear to affect college students' self-perceptions or cognitive abilities.",2019,The experimental and control groups did not differ significantly in terms of their subsequent symptom reports or their performance on any cognitive tasks.,['Participants were 157 college students'],['experimental group-which completed the World Health Organization Adult ADHD Self-Report Scale screener and received standard generic feedback-or a control group'],['cognitive tasks'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],157.0,0.0212246,The experimental and control groups did not differ significantly in terms of their subsequent symptom reports or their performance on any cognitive tasks.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Lovett', 'Affiliation': '1 State University of New York at Cortland, USA.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Jordan', 'Affiliation': '2 McLean Hospital, Belmont, MA, USA.'}]",Journal of attention disorders,['10.1177/1087054718763736']
150,32238091,"The efficacy and safety of low-frequency rotating static magnetic field therapy combined with chemotherapy on advanced lung cancer patients: a randomized, double-blinded, controlled clinical trial.","Purpose:  To evaluate the efficacy and safety of magnetic field (MF) therapy by a randomized, double-blinded, controlled clinical trial. Materials and methods:  From February 2016 to August 2019, patients with advanced lung cancer who conformed to inclusion criteria were enrolled in this study. Patients were assigned into MF therapy group (MF group, receiving both MF therapy and chemotherapy) and control group (CON group, receiving sham MF therapy and chemotherapy) randomly. The treatment course was 21 days and 2 hours per day. Changes of life quality assessment scales, objective response rate (ORR) and disease control rate (DCR) were analyzed as primary end points. The secondary end points were progression-free survival (PFS), change of blood cytokine concentrations and safety. This study has been registered on Clinicaltrials.gov (ID: NCT02701231). Results:  77 patients were enrolled and 60 finished the study. Comparing to CON group, more patients in MF group (66.7% vs 25.9%) were experiencing life quality improvement on day 21. Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma. However, the two groups were having similar ORR, DCR and PFS after treatment. Moreover, MF treatment did not increase adverse events in MF group. Conclusions:  MF therapy could improve life quality and modulate blood cytokine concentration in advanced lung cancer patients. Hence, it might be applied as an adjuvant therapy along with chemotherapy.",2020,"Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma.","['advanced lung cancer patients', '77 patients were enrolled and 60 finished the study', 'Advanced Lung Cancer Patients', 'February 2016 to August 2019, patients with advanced lung cancer who conformed to inclusion criteria were enrolled in this study']","['MF therapy', 'MF', 'MF therapy group (MF group, receiving both MF therapy and chemotherapy) and control group (CON group, receiving sham MF therapy and chemotherapy', 'Low-frequency', 'CON', 'magnetic field (MF) therapy', 'Rotating Static Magnetic Field Therapy Combined with Chemotherapy']","['efficacy and safety', 'experiencing life quality improvement', 'life quality and modulate blood cytokine concentration', 'Changes of life quality assessment scales, objective response rate (ORR) and disease control rate (DCR', 'progression-free survival (PFS), change of blood cytokine concentrations and safety', 'concentrations of IP-10 and GM-CSF', 'adverse events']","[{'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",77.0,0.151738,"Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma.","[{'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yanran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Liangan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}]",International journal of radiation biology,['10.1080/09553002.2020.1748737']
151,32266412,Multiple component analysis of attention early after complicated mild traumatic brain injury: a prospective cohort study.,"OBJECTIVE


To analyse disorders and components of attention in patients with complicated mild traumatic brain injury. This information is needed to enable clinical workers to evaluate and provide training for attention deficits in patients with mild traumatic brain injury.
DESIGN


Randomized controlled trial.
SETTING


In-patient and community recruitment.
PARTICIPANTS


In-patients with mild traumatic brain injury (n = 44) and community-recruited healthy subjects (n = 45).
OUTCOME MEASURES


All participants used a battery of attention tests including the Digit Span Test (DST), Digit Cancellation Test (D-CAT1 and D-CAT2), Symbol Digit Modalities Test (SDMT), and the Paced Auditory Serial Addition Test (PASAT).
RESULTS


There were no differences in the results of the D-CAT between the patient and control groups (p > 0.05); however, there were significant differences in the DST, SDMT and PASAT (p < 0.01).
CONCLUSION


Patients with mild traumatic brain injury were found to have normal sustained attention and selective attention, but impaired attention span, divided attention, shifting attention and information processing speed, requiring clinical workers to focus more on these deficits.",2020,"There were no differences in the results of the D-CAT between the patient and control groups (p > 0.05); however, there were significant differences in the DST, SDMT and PASAT (p < 0.01).
","['In-patients with mild traumatic brain injury (n\u2009=\u200944) and community-recruited healthy subjects (n\u2009=\u200945', 'patients with mild traumatic brain injury', 'mild traumatic brain injury', 'Patients with mild traumatic brain injury', 'In-patient and community recruitment', 'patients with complicated [AQ16] mild traumatic brain injury']",[],"['DST, SDMT and PASAT', 'Digit Span Test (DST), Digit Cancellation Test (D-CAT1 and D-CAT2), Symbol Digit Modalities Test (SDMT), and the Paced Auditory Serial Addition Test (PASAT', 'D-CAT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]",[],"[{'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0047949', 'cui_str': '4-(N,N,N-trimethylamino)-2,2,6,6-tetramethylpiperidine-1-oxyl'}, {'cui': 'C1333737', 'cui_str': 'GIT2 protein, human'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}]",,0.108652,"There were no differences in the results of the D-CAT between the patient and control groups (p > 0.05); however, there were significant differences in the DST, SDMT and PASAT (p < 0.01).
","[{'ForeName': 'Yehuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Rehabilitation Medicine, The First People's Hospital of Changzhou and Third Affiliated Hospital of Soochow University, , 213003 changzhou, China. yehuan0331@foxmail.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2673']
152,32125937,Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance).,"PURPOSE


Primary endocrine therapy for ductal carcinoma in situ (DCIS) as a potential alternative to surgery has been understudied. This trial explored the feasibility of a short-term course of letrozole and sought to determine whether treatment results in measurable radiographic and biologic changes in estrogen receptor (ER)-positive DCIS.
PATIENTS AND METHODS


A phase II single-arm multicenter cooperative-group trial was conducted in postmenopausal patients diagnosed with ER-positive DCIS without invasion. Patients were treated with letrozole 2.5 mg per day for 6 months before surgery. Breast magnetic resonance imaging (MRI) was obtained at baseline, 3 months, and 6 months. The primary end point was change in 6-month MRI enhancement volume compared with baseline.
RESULTS


Overall, 79 patients were enrolled and 70 completed 6 months of letrozole. Of these, 67 patients had MRI data available for each timepoint. Baseline MRI volumes ranged from 0.004 to 26.3 cm 3 . Median reductions from baseline MRI volume (1.4 cm 3 ) were 0.6 cm 3  (61.0%) at 3 months ( P  < .001) and 0.8 cm 3  (71.7%) at 6 months ( P  < .001). Consistent reductions were seen in median baseline ER H-score (228; median reduction, 15.0;  P  = .005), progesterone receptor H-score (15; median reduction, 85.0;  P  < .001), and Ki67 score (12%; median reduction, 6.3%;  P  = .007). Of the 59 patients who underwent surgery per study protocol, persistent DCIS remained in 50 patients (85%), invasive cancer was detected in six patients (10%), and no residual DCIS or invasive cancer was seen in nine patients (15%).
CONCLUSIONS


In a cohort of postmenopausal women with ER-positive DCIS, preoperative letrozole resulted in significant imaging and biomarker changes. These findings support future trials of extended endocrine therapy as primary nonoperative treatment of some DCIS.",2020,"Consistent reductions were seen in median baseline ER H-score (228; median reduction, 15.0;  P  = .005), progesterone receptor H-score (15; median reduction, 85.0;  P  < .001), and Ki67 score (12%; median reduction, 6.3%;  P  = .007).","['Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma', 'postmenopausal women with ER-positive DCIS, preoperative', '67 patients had MRI data available for each timepoint', 'postmenopausal patients diagnosed with ER-positive DCIS without invasion', 'ductal carcinoma in situ (DCIS', '79 patients were enrolled and 70 completed 6 months of']","['letrozole', 'Preoperative Letrozole', 'Breast magnetic resonance imaging (MRI', 'endocrine therapy']","['6-month MRI enhancement volume', 'Baseline MRI volumes', 'progesterone receptor H-score', 'median baseline ER H-score', 'invasive cancer', 'Median reductions from baseline MRI volume', 'residual DCIS or invasive cancer', 'Ki67 score', 'persistent DCIS']","[{'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}]",79.0,0.230636,"Consistent reductions were seen in median baseline ER H-score (228; median reduction, 15.0;  P  = .005), progesterone receptor H-score (15; median reduction, 85.0;  P  < .001), and Ki67 score (12%; median reduction, 6.3%;  P  = .007).","[{'ForeName': 'E Shelley', 'Initials': 'ES', 'LastName': 'Hwang', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Hyslop', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Hendrix', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Duong', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bedrosian', 'Affiliation': 'MD Anderson, Houston, TX.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Price', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Caudle', 'Affiliation': 'MD Anderson, Houston, TX.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hieken', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Guenther', 'Affiliation': 'St Elizabeth Medical Center South, Edgewood, KY.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'ASCO, Alexandria, VA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Boston, MA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Lyss', 'Affiliation': 'Missouri Baptist Medical Center, St Louis, MO.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Dickson-Witmer', 'Affiliation': 'Christiana Care Health System, Newark, DE.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Healthcare, Norfolk, VA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ollila', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hardman', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Yunn-Yi', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Krings', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Esserman', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Hylton', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00510']
153,32319175,Evaluation of the efficacy of topical sucralfate on healing haemorrhoidectomy incision wounds and reducing pain severity: A randomised clinical trial.,"The healing of haemorrhoidectomy wounds is a main concern of surgeons and patients. Various modalities can improve the quality of wound care after surgery. Antibiotics and topical agents, such as solutions and ointments, have been evaluated. The current research investigates the effects of sucralfate ointment on wound healing (epithelialisation) and postoperative pain after open haemorrhoidectomy. This trial involves two groups of randomly collected patients (n = 40) who underwent open haemorrhoidectomy surgery by the Milligan-Morgan method. A 10% topical sucralfate ointment was applied to the investigated group's wounds, while the control group patients used Vaseline as a placebo. The present work measured the two outcomes as follows: pain severity by a Visual Analogues Scale (VAS) score and epithelialisation by a surgeon's visual inspection. During the postoperative phase, the mean VAS was 3.70 for the investigated group and 6.90 for the control group. On the average, the completion of epithelialisation for the investigated group was on day 13 as opposed to day 20 for the control group. The topical application of sucralfate ointment on post-haemorrhoidectomy wound is an effective method for the promotion of healing, also lessens the severity of pain, and reduces the need for analgesics.",2020,"During the postoperative phase, the mean VAS was 3.70 for the investigated group and 6.90 for the control group.",['randomly collected patients (n = 40) who underwent'],"['topical sucralfate', 'haemorrhoidectomy', 'sucralfate ointment', 'open haemorrhoidectomy surgery by the Milligan-Morgan method', 'Vaseline as a placebo']","['wound healing (epithelialisation) and postoperative pain', ""pain severity by a Visual Analogues Scale (VAS) score and epithelialisation by a surgeon's visual inspection"", 'mean VAS', 'pain severity', 'quality of wound care', 'completion of epithelialisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038633', 'cui_str': 'Sucralfate'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",40.0,0.0200132,"During the postoperative phase, the mean VAS was 3.70 for the investigated group and 6.90 for the control group.","[{'ForeName': 'Amir K', 'Initials': 'AK', 'LastName': 'Vejdan', 'Affiliation': 'General Surgery Unit, Imam Reza Hospital, Birjand, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Khosravi', 'Affiliation': 'Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Amirian', 'Affiliation': 'Imam Reza Hospital, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daneshmand', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Babak', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Khorashdi', 'Initials': 'K', 'LastName': 'Samira', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Seifi', 'Initials': 'S', 'LastName': 'Azin', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Salehitorabi', 'Initials': 'S', 'LastName': 'Kosar', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Khodadadzadeh', 'Initials': 'K', 'LastName': 'Razie', 'Affiliation': 'Department of general surgery, Birjand University of Medical Sciences, Birjand, Iran.'}]",International wound journal,['10.1111/iwj.13369']
154,32213475,Importance of Photography Education to Improve Image Quality for Accurate Remote Diagnoses in Dental Trauma Patients: Observational Study.,"BACKGROUND


High-quality photos are critical for the remote diagnosis of dental trauma and thus are beneficial to the prognosis. The quality of the images obtained using a cell phone depends on the level of dental and photography knowledge of the person who is taking the photos.
OBJECTIVE


This study aimed to determine the efficacy of photography education in improving images used for the remote diagnosis of dental trauma.
METHODS


The subjects comprised 30 laypeople and 30 dentists who were randomly assigned to 15 subgroups with 2 subjects in each. Each subject was asked to take photos of their own anterior teeth and those of their partner on the assumption that an accident occurred using both an iPhone 4s and iPhone 6. Education about how to take an appropriate photo of the anterior teeth for teleconsultation purposes was then provided, after which photos were taken again. Photos were assessed by a dentist for their usefulness in diagnosis.
RESULTS


This study analyzed 965 photos: 441 taken by laypeople and 524 taken by dentists. Photos taken after providing education had significantly higher scores for all assessment items than those taken before education (P<.05). The scores were also significantly higher for photos taken using the rear camera than those taken using the front camera (P<.02). The iPhone 6 did not have overwhelming advantages. The photos taken by dentists had significantly higher scores than those taken by laypeople for most of the evaluated items.
CONCLUSIONS


Both laypeople and dentists might find photography education useful for when they are taking photos to be used in teleconsultations. The type of cell phone does not significantly affect the usefulness of such photos.",2020,"The photos taken by dentists had significantly higher scores than those taken by laypeople for most of the evaluated items.
","['965 photos: 441 taken by laypeople and 524 taken by dentists', 'Dental Trauma Patients', 'subjects comprised 30 laypeople and 30 dentists who were randomly assigned to 15 subgroups with 2 subjects in each']","['Photography Education', 'photography education']",[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C1301685', 'cui_str': 'Dental trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0196894,"The photos taken by dentists had significantly higher scores than those taken by laypeople for most of the evaluated items.
","[{'ForeName': 'Jin-Sun', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'School and Hospital of Stomatology, Shandong University, Jinan, China.'}, {'ForeName': 'Nan-Sim', 'Initials': 'NS', 'LastName': 'Pang', 'Affiliation': 'Department of Advanced General Dentistry, College of Dentistry, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Yiseul', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Advanced General Dentistry, College of Dentistry, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyeong-Mee', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'Department of Advanced General Dentistry, College of Dentistry, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Taekbin', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Advanced General Dentistry, College of Dentistry, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'School and Hospital of Stomatology, Shandong University, Jinan, China.'}, {'ForeName': 'Wonse', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Advanced General Dentistry, College of Dentistry, Yonsei University, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/15152']
155,31806653,"Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).","OBJECTIVE


To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS


Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs.
RESULTS


Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91;  P  = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo ( P  = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914;  P  ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914;  P  < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204;  P  < 0.01). There were no significant differences in EQ-5D health utilities between arms over time.
CONCLUSIONS


Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.",2020,"There were no significant differences in EQ-5D health utilities between arms over time.
","['14,752 patients with type 2 diabetes', 'Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL']","['placebo', 'EQW', 'exenatide (EQW) or placebo']","['Rates of outpatient medical visits', 'English costs', 'estimated cost of EQW, total mean costs', 'total costs', 'Mean costs for nonstudy diabetes medications', 'Costs, and Quality of Life', 'EQ-5D health utilities', 'mean total costs, including exenatide costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]",1670.0,0.094758,"There were no significant differences in EQ-5D health utilities between arms over time.
","[{'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC shelby.reed@duke.edu.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gustavson', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Kartman', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wittbrodt', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Oxford Health Economic Research Centre, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0950']
156,31995223,Describing Return to Work after Stroke: A Feasibility Trial of 12-month Outcomes.,"OBJECTIVE


Stroke is the greatest cause of disability in adults. A quarter of strokes affect people of working age, yet under half return to work after stroke. There has been little investigation into what constitutes ""return to work"" following stroke. The aim of this study is to describe the work metrics of stroke survivor participants in a feasibility randomized controlled trial of an early stroke-specific vocational rehabilitation intervention.
METHODS


Retrospective analysis of trial data. Metrics on work status, working hours, workplace accommodations and costs were extracted from trial outcomes gathered by postal questionnaire at 3, 6, and 12 months' post-randomization for 46 stroke participants in a feasibility randomized controlled trial. Participants were randomized to receive vocational rehabilitation (intervention) or usual care (control).
RESULTS


Two-thirds (n = 29; 63%) of participants returned to work at some point in the 12 months following stroke. Participants took a mean of 90 days to return to work. Most returned to the same role with an existing employer. Only one-third of participants who were employed full-time at stroke onset were working full-time at 12 months post-stroke. Most participants experienced a reduction in pre-stroke earnings. Workplace accommodations were more common among intervention group participants. More intervention participants than control participants reported satisfaction with work at both 6 and 12 months post-randomization.  Conclusion: This study illustrates the heterogeneous nature of return to work and the dramatic impact of stroke on work status, working hours and income. Longitudinal research should explore the socioeconomic legacy of stroke and include clear definitions of work and accurate measures of working hours and income from all sources.",2020,Workplace accommodations were more common among intervention group participants.,"['adults', 'stroke survivor participants', '46 stroke participants']","['vocational rehabilitation (intervention) or usual care (control', 'early stroke-specific vocational rehabilitation intervention']","['Workplace accommodations', 'work status, working hours, workplace accommodations and costs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.133747,Workplace accommodations were more common among intervention group participants.,"[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Radford', 'Affiliation': 'The University of Nottingham, Queens Medical Centre, , NG7 2UH Nottingham, United Kingdom. kate.radford@nottingham.ac.uk.'}, {'ForeName': 'Mary I', 'Initials': 'MI', 'LastName': 'Grant', 'Affiliation': ''}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Sinclair', 'Affiliation': ''}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Kettlewell', 'Affiliation': ''}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Watkin', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2647']
157,32217500,Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial.,"BACKGROUND


As people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission.
OBJECTIVE


This study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore.
METHODS


We conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device-Medication Event Monitoring System (MEMS)-and a mobile app-MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention.
RESULTS


All participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results.
CONCLUSIONS


Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app-assisted intervention RCTs in the future.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648.",2020,"The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention.","['HIV-infected adults in Singapore', '40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the', 'people living with HIV infection', 'People Living With HIV']","['mobile app, Mobile Interactive Supervised Therapy (MIST', 'Mobile Interactive Supervised Therapy Intervention', 'intervention (receiving MIST and routine care) or control (receiving routine care only) groups', 'MIST']","['7-day recall self-report (SR), pill count (PC), an electronic medical device-Medication Event Monitoring System (MEMS)-and a mobile app-MIST', 'antiretroviral therapy (ART) adherence', 'ART adherence', 'acceptability of MIST', 'excellent medication adherence']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0025080', 'cui_str': 'Medical Devices'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",20.0,0.237976,"The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'James Steven', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'University Medicine Cluster, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Wei Tsang', 'Initials': 'WT', 'LastName': 'Ooi', 'Affiliation': 'School of Computing, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Nicholas Iain', 'Initials': 'NI', 'LastName': 'Paton', 'Affiliation': 'University Medicine Cluster, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Hong-Gu', 'Initials': 'HG', 'LastName': 'He', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/15702']
158,32042166,An electroencephalographic signature predicts antidepressant response in major depression.,"Antidepressants are widely prescribed, but their efficacy relative to placebo is modest, in part because the clinical diagnosis of major depression encompasses biologically heterogeneous conditions. Here, we sought to identify a neurobiological signature of response to antidepressant treatment as compared to placebo. We designed a latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG) and applied it to data from the largest imaging-coupled, placebo-controlled antidepressant study (n = 309). Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment. This sertraline-predictive EEG signature generalized to two depression samples, wherein it reflected general antidepressant medication responsivity and related differentially to a repetitive transcranial magnetic stimulation treatment outcome. Furthermore, we found that the sertraline resting-state EEG signature indexed prefrontal neural responsivity, as measured by concurrent transcranial magnetic stimulation and EEG. Our findings advance the neurobiological understanding of antidepressant treatment through an EEG-tailored computational model and provide a clinical avenue for personalized treatment of depression.",2020,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,['major depression'],"['placebo', 'latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG']","['sertraline resting-state EEG signature indexed prefrontal neural responsivity', 'Symptom improvement']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.035978,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'School of Automation Science and Engineering, South China University of Technology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Molly V', 'Initials': 'MV', 'LastName': 'Lucas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Carena A', 'Initials': 'CA', 'LastName': 'Cornelssen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hersh M', 'Initials': 'HM', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Monuszko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Caudle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kamron', 'Initials': 'K', 'LastName': 'Sarhadi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}]",Nature biotechnology,['10.1038/s41587-019-0397-3']
159,32298270,Sensory focused exercise improves anxiety in Parkinson's disease: A randomized controlled trial.,"Anxiety has been implicated as one of the greatest influences on quality of life in Parkinson's disease (PD). The etiology of anxiety is unclear, although previous work suggests that anxiety may be linked to sensory deficits that cause uncertainty in movement. Thus, the current study examined whether focusing attention on sensory feedback during goal-based exercise has the potential to provide benefits to anxiety in PD. Thirty-five participants with PD were randomized to either a Sensory Attention Focused Exercise (SAFEx) (i.e. internal focus of attention, n = 18) or Sham Exercise control (i.e. external focus of attention, n = 17) and completed 33 one-hour attention-based exercise sessions over 11-weeks. Before and after the program (pre and post), participants completed the Parkinson Anxiety Scale (PAS) questionnaire. The PAS includes three anxiety sections: persistent, episodic, and avoidance. Changes in the total PAS score and within each section of the PAS were subjected to two-factor mixed repeated measures ANCOVA. Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) = 5.41, p = 0.028, ηp2 = 0.17; ΔEpisodic Score = -1.8, F(1,27) = 6.89, p = 0.014, ηp2 = 0.20). In conclusion, focusing attention on sensory feedback while completing goal-based exercises may provide significant benefits to improving anxiety in PD. As such, sensory attention focused exercise may be a critical adjunct therapy for improving anxiety, and ultimately quality of life in people with PD.",2020,"Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) =","[""Parkinson's disease"", 'people with PD', 'Thirty-five participants with PD']","['Sensory focused exercise', 'Sensory Attention Focused Exercise (SAFEx) (i.e. internal focus of attention, n = 18) or Sham Exercise control (i.e. external focus of attention, n = 17) and completed 33 one-hour attention-based exercise sessions']","['Parkinson Anxiety Scale (PAS) questionnaire', 'total PAS scores', 'episodic anxiety scores', 'total PAS score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",35.0,0.065919,"Significant group by time interactions demonstrated that from pre to post, total PAS scores (p = 0.007) and episodic anxiety scores (p = 0.010) significantly decreased in the SAFEx group only (ΔTotal PAS = -5.2, F(1,27) =","[{'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Beck', 'Affiliation': 'School of Medicine, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Mary T Y', 'Initials': 'MTY', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Intzandt', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Quincy J', 'Initials': 'QJ', 'LastName': 'Almeida', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Kaylena A', 'Initials': 'KA', 'LastName': 'Ehgoetz Martens', 'Affiliation': 'Department of Kinesiology and Physical Education, Movement Disorders Research & Rehabilitation Centre, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0230803']
160,32298326,Socio-ecological correlates of physical activity in breast and colon cancer survivors 4 years after participation in a randomized controlled exercise trial (PACT study).,"BACKGROUND


Having a physically active lifestyle after cancer diagnosis is beneficial for health, and this needs to be continued into survivorship to optimize long-term benefits. We found that patients, who participated in an 18-week exercise intervention, reported significant higher physical activity (PA) levels 4 years after participation in a randomized controlled trial of supervised exercise delivered during chemotherapy (PACT study). This study aimed to identify social-ecological correlates of PA levels in breast and colon cancer survivors 4 years after participation in the PACT study.
METHODS


Self-reported PA levels and potential correlates (e.g. physical fitness, fatigue, exercise history, and built environment) were assessed in 127 breast and colon cancer survivors shortly after diagnosis (baseline), post-intervention and 4 years later. Multivariable linear regression analyses were performed to identify social-ecological correlates of PA 4 years post-baseline.
RESULTS


The final model revealed that lower baseline physical fatigue (β = -0.25, 95% CI -0.26; -0.24) and higher baseline total PA (0.06, 95% CI, 0.03; 0.10) were correlated with higher total PA levels 4 years post-baseline. Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (-8.07, 95% CI -14.00; -2.13), and having a positive change in physical fatigue during the intervention period (0.04, 95% CI 0.001; 0.07) were correlates of sport and leisure PA levels 4 years post-baseline.
CONCLUSIONS


This study suggests that baseline and 4-year post-baseline physical fatigue, and past exercise behaviour, were significant correlates of PA 4 years after participation in an exercise trial. Additionally, this study suggests that the built environment should be taken into account when promoting PA. Understanding of socio-ecological correlates of PA can provide insights into how future exercise interventions should be designed to promote long-term exercise behaviour.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on 9 December 2009, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2138.",2020,"Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (","['breast and colon cancer survivors 4 years after participation in the PACT study', 'breast and colon cancer survivors 4 years after participation', '127 breast and colon cancer survivors shortly after diagnosis (baseline), post-intervention and 4 years later']","['supervised exercise delivered during chemotherapy', '18-week exercise intervention']","['physical activity (PA) levels', 'lower physical fatigue', 'recreational facilities', 'total PA levels', 'baseline total PA', 'baseline physical fatigue', 'PA levels and potential correlates (e.g. physical fitness, fatigue, exercise history, and built environment', 'physical fatigue']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442550', 'cui_str': 'Recreational facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0457992', 'cui_str': 'Exercise history'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}]",,0.137861,"Higher baseline leisure and sport PA (0.02, 95% CI 0.01; 0.03), more recreational facilities within a buffer of 1 km (4.05, 95% CI = 1.28; 6.83), lower physical fatigue at 4-year follow-up (","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Jansen', 'Affiliation': 'Department of Human Geography and Spatial Planning, Faculty of Geosciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Frank J G', 'Initials': 'FJG', 'LastName': 'Backx', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sport, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Miranda J', 'Initials': 'MJ', 'LastName': 'Velthuis', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0231663']
161,32298381,The implementation of a nutrition protocol in a surgical intensive care unit; a randomized controlled trial at a tertiary care hospital.,"BACKGROUND


Malnutrition in critically ill patients is linked with significant mortality and morbidity. However, it remains controversial whether nutrition therapy protocols are effective in improving clinical outcomes. The present study aimed to evaluate the effectiveness of a surgical ICU nutrition protocol, and to compare the hospital mortality, hospital LOS, and ICU LOS of protocol and non-protocol groups.
METHODS


A randomized controlled trial was conducted at the Surgical ICU, Siriraj Hospital. The nutrition administration of the control group was at the discretion of the attending physicians, whereas that of the intervention group followed the ""Siriraj Surgical ICU Nutrition Protocol"". Details of the demographic data, nutritional data, and clinical outcomes were collected.
RESULTS


In all, 170 patients underwent randomization, with 85 individuals each in the protocol and non-protocol groups. More than 90% of the patients in both groups were at risk of malnutrition, indicated by a score of ≥ 3 on the Nutritional Risk Screening 2002 tool. The average daily calories of the 2 groups were very similar (protocol group, 775.4±342.2 kcal vs. control group, 773.0±391.9 kcal; p = 0.972). However, the median time to commence enteral nutrition was shorter for the protocol group (1.94 days) than the control group (2.25 days; p = 0.503). Enteral nutrition was provided within the first 48 hours to 53.7% of the protocol patients vs. 47.4% of the control patients (p = 0.589). In addition, a higher proportion of the protocol patients (36.5%) reached the 60% calorie-target on Day 4 after admission than that for the non-protocol group (25.9%; p = 0.136). All other clinical outcomes and nutrition-related complications were not significantly different.
CONCLUSIONS


The implementation of the nutrition protocol did not improve the feeding effectiveness or clinical outcomes as compared to usual nutrition management practices of the Surgical ICU.",2020,The implementation of the nutrition protocol did not improve the feeding effectiveness or clinical outcomes as compared to usual nutrition management practices of the Surgical ICU.,"['critically ill patients', '170 patients underwent randomization, with 85 individuals each in the protocol and non-protocol groups']",['surgical ICU nutrition protocol'],"['average daily calories', 'Enteral nutrition', 'median time to commence enteral nutrition', 'hospital mortality, hospital LOS, and ICU LOS']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",170.0,0.0673065,The implementation of the nutrition protocol did not improve the feeding effectiveness or clinical outcomes as compared to usual nutrition management practices of the Surgical ICU.,"[{'ForeName': 'Pornrat', 'Initials': 'P', 'LastName': 'Chinda', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pulyamon', 'Initials': 'P', 'LastName': 'Poomthong', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Puriwat', 'Initials': 'P', 'LastName': 'Toadithep', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chayanan', 'Initials': 'C', 'LastName': 'Thanakiattiwibun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Onuma', 'Initials': 'O', 'LastName': 'Chaiwat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0231777']
162,32315362,Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.,"INTRODUCTION


The RAINBOW randomized clinical trial validated the efficacy of an integrated collaborative care intervention for obesity and depression in primary care, although the effect was modest. To inform intervention optimization, this study investigated within-treatment variability in participant engagement and progress.
METHODS


Data were collected in 2014-2017 and analyzed post hoc in 2018. Cluster analysis evaluated patterns of change in weekly self-monitored weight from week 6 up to week 52 and depression scores on the Patient Health Questionnaire-9 (PHQ-9) from up to 15 individual sessions during the 12-month intervention. Chi-square tests and ANOVA compared weight loss and depression outcomes objectively measured by blinded assessors to validate differences among categories of treatment engagement and progress defined based on cluster analysis results.
RESULTS


Among 204 intervention participants (50.9 [SD, 12.2] years, 71% female, 72% non-Hispanic White, BMI 36.7 [6.9], PHQ-9 14.1 [3.2]), 31% (n = 63) had poor engagement, on average completing self-monitored weight in <3 of 46 weeks and <5 of 15 sessions. Among them, 50 (79%) discontinued the intervention by session 6 (week 8). Engaged participants (n = 141; 69%) self-monitored weight for 11-22 weeks, attended almost all 15 sessions, but showed variable treatment progress based on patterns of change in self-monitored weight and PHQ-9 scores over 12 months. Three patterns of weight change (%) represented minimal weight loss (n = 50, linear β1 = -0.06, quadratic β2 = 0.001), moderate weight loss (n = 61, β1 = -0.28, β2 = 0.002), and substantial weight loss (n = 12, β1 = -0.53, β2 = 0.005). Three patterns of change in PHQ-9 scores represented moderate depression without treatment progress (n = 40, intercept β0 = 11.05, β1 = -0.11, β2 = 0.002), moderate depression with treatment progress (n = 20, β0 = 12.90, β1 = -0.42, β2 = 0.006), and milder depression with treatment progress (n = 81, β0 = 7.41, β1 = -0.23, β2 = 0.003). The patterns diverged within 6-8 weeks and persisted throughout the intervention. Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.
CONCLUSIONS


Participants demonstrating poor engagement or poor progress could be identified early during the intervention and were more likely to fail treatment at the end of the intervention. This insight could inform individualized and timely optimization to enhance treatment efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov# NCT02246413.",2020,"Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.
","['primary care patients with obesity and depression', '204 intervention participants (50.9 [SD, 12.2] years, 71% female, 72% non-Hispanic White, BMI 36.7 [6.9], PHQ-9 14.1 [3.2]), 31% (n = 63) had poor engagement, on average completing self-monitored weight in <3 of 46 weeks and <5 of 15 sessions', 'Engaged participants (n = 141; 69', 'Data were collected in 2014-2017 and analyzed post hoc in 2018']",['integrated collaborative care intervention'],"['milder depression', 'weight loss and depression outcomes', 'weight change', 'moderate weight loss', 'self-monitored weight', 'substantial weight loss', 'moderate depression', 'self-monitored weight and PHQ-9 scores', 'minimal weight loss']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",,0.0287906,"Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, University Park, Pennsylvania, United States of America.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, University Park, Pennsylvania, United States of America.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Health Research and Policy and Medicine, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': 'Pacific Coast Psychiatric Associates, San Francisco, California, United States of America.'}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Lesser', 'Affiliation': 'One Medical, San Francisco, California, United States of America.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': 'Sutter Health Research Enterprise, Center for Health Systems Research, Walnut Creek, California, United States of America.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0231743']
163,32320100,Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty.,"AIMS AND OBJECTIVES


To evaluate the efficacy and safety of a comprehensive protocol for constipation prevention.
BACKGROUND


Constipation is a common problem for patients undergoing total hip arthroplasty (THA), yet sparse evidence is available to guide constipation prevention after THA.
DESIGN


Randomised controlled superiority clinical trial.
METHODS


This randomised controlled study was carried out according to the Consolidated Standards of Reporting Trials (CONSORT). A total of 80 THA patients were randomised to receive only preoperative education about lifestyle or the combination of education with postoperative abdominal massage and polyethylene glycol 4,000 (Forlax®). Efficacy outcomes included rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days. Safety outcomes were number and type of adverse events.
RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalisation than patients who received only preoperative education (25% versus 55%), and they showed a significantly lower rate of enema rescue (12.5% versus 40%). Many more patients receiving combination treatment experienced their first defecation within two postoperative days than patients who received only preoperative education (62.5% versus 35.9%). In contrast, the two groups were similar in terms of constipation rate on postoperative days 15 and 30, rate of readmission within 30 days and rate of postoperative adverse events.
CONCLUSIONS


These results suggest that our comprehensive protocol can relieve constipation after THA, reduce the need for enema rescue and shorten time to first defecation without sacrificing safety. More work is needed to optimise and develop this protocol further.
RELEVANCE TO CLINICAL PRACTICE


Constipation is a distressing problem that frequently occurs after THA. This study confirmed that a comprehensive protocol including preoperative education, postoperative abdominal massage and polyethylene glycol 4,000 can effectively relieve constipation after THA without sacrificing safety.",2020,"RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","['80 THA patients', 'constipation following total hip arthroplasty', 'patients undergoing total hip arthroplasty (THA']","['preoperative education, postoperative abdominal massage and polyethylene glycol', 'preoperative education about lifestyle, or the combination of education with postoperative abdominal massage and polyethylene glycol 4000 (Forlax®', 'comprehensive protocol']","['rate of readmission within 30 days, and rate of postoperative adverse events', 'rate of postoperative constipation during hospitalization', 'efficacy and safety', 'rate of enema rescue', 'rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days', 'constipation rate', 'number and type of adverse events']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0948179', 'cui_str': 'Postoperative constipation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",80.0,0.108095,"RESULTS


Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15299']
164,32315330,Effects of hyperoxia on dynamic muscular endurance are associated with individual whole-body endurance capacity.,"Low-intensity training involving high repetitions is recommended to enhance muscular endurance. Hyperoxic conditions could increase the number of repetitions until exhaustion and thereby improve the results of muscular endurance training. This study aimed to investigate the acute effects of hyperoxia on dynamic muscular endurance, and determine individual factors that may be related to these effects. A single-blinded, counterbalanced crossover design was used. Twenty-five young men performed repetitions of the one-arm preacher curl at 30% of their 1-repetition maximum until exhaustion under hyperoxic and normoxic conditions. The maximum number of repetitions was recorded as an index of muscular endurance. Electromyogram (EMG) and near-infrared spectroscopy parameters were measured in the biceps brachii. The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions). The root mean square amplitude of EMG and oxygenated hemoglobin concentration for the last five repetitions under normoxic conditions were greater than those under hyperoxic conditions (P = 0.015 and P = 0.003, respectively). The percent change in the maximum number of repetitions between hyperoxic and normoxic conditions had significant positive correlations with individual maximal oxygen uptake measured using an incremental cycle ergometer test (r = 0.562, 95% confidence intervals [CI] = 0.213-0.783, P = 0.003), but not with muscle strength (τ = -0.124, 95% CI = -0.424-0.170, P = 0.387). The 95% CI for the correlation coefficient between the percent change in the maximum number of repetitions and muscular endurance included 0 (τ = 0.284, 95% CI = -0.003-0.565, P = 0.047); this indicated no significant correlation between the two parameters. The results suggest that hyperoxia can acutely enhance dynamic muscular endurance, with delayed elevation of EMG amplitude due to fatigue, and the effects are associated with individual whole-body endurance capacity.",2020,The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions).,['Twenty-five young men performed repetitions of the one-arm preacher curl at 30% of their 1-repetition maximum until exhaustion under hyperoxic and normoxic conditions'],['hyperoxia'],"['number of repetitions until exhaustion and thereby improve the results of muscular endurance training', 'muscle strength', 'maximum number of repetitions', 'Electromyogram (EMG) and near-infrared spectroscopy parameters', 'maximum number of repetitions and muscular endurance', 'individual maximal oxygen uptake', 'root mean square amplitude of EMG and oxygenated hemoglobin concentration', 'dynamic muscular endurance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",25.0,0.110831,The maximum number of repetitions was greater (P < 0.001) under hyperoxic conditions (132 ± 59 repetitions) than under normoxic conditions (114 ± 40 repetitions).,"[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Human and Engineered Environmental Studies, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Fukusaki', 'Affiliation': 'Research Center for Total Life Health and Sports Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Naokata', 'Initials': 'N', 'LastName': 'Ishii', 'Affiliation': 'Research Center for Total Life Health and Sports Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0231643']
165,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P  = 0.001) and -1.2% for placebo ( P  = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%;  P  = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P  = 0.028), and a difference between arms ( P  = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050']
166,31618539,Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.,"BACKGROUND


Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine).
METHODS


Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year.
RESULTS


A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17).
CONCLUSIONS


Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).",2019,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","['If patients were found to have reflux-related heartburn', '288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality', '366 patients (mean age, 48.5 years; 280 men) were enrolled', 'patients referred to VA gastroenterology clinics for PPI-refractory heartburn', 'Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of', 'twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring']","['desipramine', 'omeprazole', 'proton-pump inhibitor (PPI', 'surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo']","['Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score', 'incidence of treatment success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0014852', 'cui_str': 'Esophageal Diseases'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4302237', 'cui_str': 'Functional heartburn (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0192269', 'cui_str': 'Biopsy of esophagus (procedure)'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry (procedure)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",288.0,0.117934,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Spechler', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Hunter', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mashimo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Vivian M', 'Initials': 'VM', 'LastName': 'Sanchez', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Dunbar', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Thai H', 'Initials': 'TH', 'LastName': 'Pham', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Uma K', 'Initials': 'UK', 'LastName': 'Murthy', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Taewan', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Jackson', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wallen', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Erik C', 'Initials': 'EC', 'LastName': 'von Rosenvinge', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Pearl', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Laine', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaz', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Roger P', 'Initials': 'RP', 'LastName': 'Tatum', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ziad F', 'Initials': 'ZF', 'LastName': 'Gellad', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Lagoo-Deenadayalan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Rubenstein', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Ghaferi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Wai-Kit', 'Initials': 'WK', 'LastName': 'Lo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Fernando', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Bobby S', 'Initials': 'BS', 'LastName': 'Chan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shirley C', 'Initials': 'SC', 'LastName': 'Paski', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Provenzale', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Castell', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lieberman', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Rhonda F', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Warren', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davis-Karim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Melton', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Serpi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa1811424']
167,30891886,Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2.,"AIM


This study aimed to investigate the safety of insulin degludec (degludec) in relation to age and risk of hypoglycaemia post hoc in individuals with type 2 diabetes (T2D) (SWITCH 2 trial).
METHODS


In this crossover study, individuals with T2D who were at risk of hypoglycaemia were randomized to double-blind treatment with degludec or insulin glargine 100 units/mL (glargine U100) ± oral antidiabetic drugs. After 32 weeks, patients crossed over to the other treatment. Primary endpoint was number of overall severe (positively adjudicated) or glucose-confirmed (plasma glucose <56 mg/dL; 3.1 mmol/L) symptomatic hypoglycaemia events during the two 16-week maintenance periods.
RESULTS


For individuals ≤65 (n = 450) and >65 (n = 270) years, baseline median (range) duration of diabetes was 12 (1-40) vs 15 (1-54) years, mean HbA1c was 7.7% vs 7.4% and mean estimated glomerular filtration rate was 87.0 vs 63.7 mL/min/1.73 m 2  , respectively. No significant differences in HbA1c reduction were seen in individuals ≤65 or >65 years. During both maintenance periods, treatment with degludec lowered rates of hypoglycaemia (overall/nocturnal symptomatic) vs those with glargine U100 in individuals ≤65 (31% vs 43%) and >65 (30% vs 41%) years. With degludec and glargine U100, respectively, six vs nine severe hypoglycaemic events occurred in individuals ≤65 years and four vs eight events occurred in those >65 years. Adverse event rates were 3.2 and 3.3 events/patient-year for individuals ≤65 years and were 3.5 and 4.1 events/patient-year for individuals >65 years with degludec and glargine U100, respectively.
CONCLUSION


Treatment with degludec was safe and effective, with a frequency of hypoglycaemia lower than that with glargine U100 in both younger and older individuals (>65 years) with T2D.",2019,"Adverse event rates were 3.2 and 3.3 events/patient-year for individuals ≤65 years and were 3.5 and 4.1 events/patient-year for individuals >65 years with degludec and glargine U100, respectively.
","['younger and older individuals (>65\u2009years) with T2D', 'individuals with T2D who were at risk of hypoglycaemia', 'individuals with type 2 diabetes (T2D) (SWITCH 2 trial', 'older individuals with type 2 diabetes using']","['insulin degludec (degludec', 'degludec or insulin glargine 100\u2009units/mL (glargine U100) ± oral antidiabetic drugs', 'insulin degludec versus insulin glargine U100']","['number of overall severe (positively adjudicated) or glucose-confirmed (plasma glucose', 'HbA1c reduction', 'baseline median (range) duration of diabetes', 'symptomatic hypoglycaemia events', 'hypoglycaemia', 'rates of hypoglycaemia', 'severe hypoglycaemic events', 'Adverse event rates', 'glomerular filtration rate']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",,0.146007,"Adverse event rates were 3.2 and 3.3 events/patient-year for individuals ≤65 years and were 3.5 and 4.1 events/patient-year for individuals >65 years with degludec and glargine U100, respectively.
","[{'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wysham', 'Affiliation': 'School of Medicine, University of Washington/Multicare Rockwood Clinic, Spokane, Washington.'}, {'ForeName': 'Charlotte T', 'Initials': 'CT', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Centre, University of Edinburgh, Edinburgh, UK.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13708']
168,32199184,A randomized controlled trial of social skills training for patients with treatment-resistant schizophrenia with predominantly negative symptoms.,"We conducted a randomized controlled trial to assess the effectiveness of social skills training (SST) in improving negative symptoms in patients with treatment-resistant schizophrenia with predominantly negative symptoms. Patients were randomized to receive SST (n = 29) or to a control group (n = 33), in a 20-week program with weekly group sessions. Patients were assessed at baseline, post-treatment (20 weeks) and 6-month follow-up with the Positive and Negative Syndrome Scale. There was no significant improvement in the negative symptoms in either group, at any timepoint. Caution is warranted to interpret the results due to small sample size.",2020,"There was no significant improvement in the negative symptoms in either group, at any timepoint.",['patients with treatment-resistant schizophrenia with predominantly negative symptoms'],"['social skills training', 'social skills training (SST', 'SST']",['negative symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0532207,"There was no significant improvement in the negative symptoms in either group, at any timepoint.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kayo', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil. Electronic address: monica.kayo@gmail.com.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Scemes', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Mariangela Gentil', 'Initials': 'MG', 'LastName': 'Savoia', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bichuette', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Ana Claudia', 'Initials': 'AC', 'LastName': 'Abreu', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Emily Pereira', 'Initials': 'EP', 'LastName': 'da Silva', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Baria', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Piovaccari', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Petreche', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Rodrigo Affonseca', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Gadelha', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Elkis', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Hospital das Clínicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, Rua Dr. Ovidio Pires de Campos 785, 3rd floor, São Paulo, SP 05403-010, Brazil. Electronic address: helkis@usp.br.'}]",Psychiatry research,['10.1016/j.psychres.2020.112914']
169,32073177,Posttraumatic Growth After MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder.,"3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder (PTSD) has been shown to significantly reduce clinical symptomatology, but posttraumatic growth (PTG), which consists of positive changes in self-perception, interpersonal relationships, or philosophy of life, has not been studied with this treatment. Participant data (n = 60) were pooled from three Phase 2 clinical studies employing triple-blind crossover designs. Participants were required to meet DSM-IV-R criteria for PTSD with a score higher than 50 on the Clinician-Administered PTSD Scale (CAPS-IV) as well as previous inadequate response to pharmacological and/or psychotherapeutic treatment. Data were aggregated into two groups: an active MDMA dose group (75-125 mg of MDMA; n = 45) or placebo/active control (0-40 mg of MDMA; n = 15). Measures included the Posttraumatic Growth Inventory (PTGI) and the CAPS-IV, which were administered at baseline, primary endpoint, treatment exit, and 12-month follow-up. At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group. Relative to baseline, at the 12-month follow-up, within-subject PTG was higher, p < .001; PTSD symptom severity scores were lower, p < .001; and two-thirds of participants (67.2%) no longer met criteria for PTSD. MDMA-assisted psychotherapy for PTSD resulted in PTG and clinical symptom reductions of large-magnitude effect sizes. Results suggest that PTG may provide a new mechanism of action warranting further study.",2020,"At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group.",['posttraumatic stress disorder (PTSD'],"['3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy', 'MDMA-Assisted Psychotherapy', 'MDMA', 'PTG', 'MDMA-assisted psychotherapy', 'placebo/active control (0-40 mg of MDMA']","['Posttraumatic Growth', 'PTSD symptom severity scores', 'Posttraumatic Growth Inventory (PTGI) and the CAPS-IV', 'PTSD symptom severity']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",60.0,0.0371367,"At primary endpoint, the MDMA group demonstrated more PTG, Hedges' g = 1.14, 95% CI [0.49, 1.78], p < .001; and a larger reduction in PTSD symptom severity, Hedges' g = 0.88, 95% CI [-0.28, 1.50], p < .001, relative to the control group.","[{'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Gorman', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Belser', 'Affiliation': 'School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hennigan', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Shechet', 'Affiliation': 'Scottsdale Research Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford University School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, California, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Emerson', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Feduccia', 'Affiliation': 'MAPS Public Benefit Corporation, Santa Cruz, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22479']
170,32203751,Improving social functioning in community-dwelling patients with schizophrenia: a randomized controlled computer cognitive remediation therapy trial with six months follow-up.,"Computerized cognitive remediation therapy (CCRT) has been found to generally improve cognition among patients with schizophrenia, but its effect on functioning has not been extensively studied. This study addressed this gap in the literature by investigating the effect of CCRT and its long-term efficacy among community-dwelling patients with schizophrenia. 157 Chinese patients with schizophrenia were recruited from communities and randomized to CCRT (n = 78) or treatment as usual (TAU; n = 79) groups for 12 weeks with 4-5 sessions per week. Neurocognition, functioning, and symptoms of participants were assessed at baseline, after treatment, and at the 6 month follow-up. The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score. Significant cognitive benefits for functioning were observed (Personal and Social Performance scale, PSP). Moreover, improvement of the MCCB total score mediated a positive effect on functional capacity (UCSD Performance-based Skills Assessment, UPSA), and mediated decreases in negative symptoms across both groups. CCRT improved social functioning and general cognitive functioning among community-dwelling patients with schizophrenia. These improvements persisted for 6 months after treatment. CCRT also led to improvements in functioning and symptom severity by modulating cognitive functioning.",2020,The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score.,"['community-dwelling patients with schizophrenia', '157 Chinese patients with schizophrenia', 'patients with schizophrenia']","['TAU', 'Computerized cognitive remediation therapy (CCRT', 'CCRT']","['functional capacity (UCSD Performance-based Skills Assessment, UPSA', 'Consensus Cognitive Battery (MCCB) total score and social cognition score', 'social functioning', 'MCCB total score', 'Significant cognitive benefits for functioning were observed (Personal and Social Performance scale, PSP', 'social functioning and general cognitive functioning', 'Neurocognition, functioning, and symptoms', 'negative symptoms']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",157.0,0.0232688,The CCRT group showed significantly greater improvements than the TAU group regarding the MATRICS Consensus Cognitive Battery (MCCB) total score and social cognition score.,"[{'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Zhiren', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Beijing Dongcheng District Institute of Mental Health Care, Beijing 100027, PR. China.'}, {'ForeName': 'Cunli', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Pingan Hospital of Xicheng District, Beijing 100023, PR. China.'}, {'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Beijing Haidian District Institute of Mental Health Prevention, Beijing 100193, PR. China.'}, {'ForeName': 'Zhiwu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Nanyuan Hospital of Fengtai District, Beijing 10076, PR. China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'The third Hospital of Chaoyang District, Beijing 100121, PR. China.'}, {'ForeName': 'Yizhuang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China. Electronic address: yzouy@263.net.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing 100096, PR. China. Electronic address: shupingtan@126.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.112913']
171,32311349,Pneumonia and Exposure to Household Air Pollution in Children Under the Age of 5 Years in Rural Malawi: Findings From the Cooking and Pneumonia Study.,"BACKGROUND


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


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


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


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


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


ISRCTN59448623.",2020,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","['children under the age of 5 years in rural Malawi', 'children under the age of 5 years in rural Malawi - the Cooking And Pneumonia Study (CAPS', 'children participating in a cluster-randomised controlled trial of a', 'young children instead', 'We recruited 1805 (928 intervention; 877 control) children (mean age 25.6 months, 50.6% female', 'children under the age of 5 in rural Malawi']","['COHb ', 'CAPS intervention', 'personal exposure to carbon monoxide (CO', 'transcutaneous carboxyhemoglobin (COHb', 'cleaner-burning biomass-fueled cookstove intervention']",['Median exposure to CO'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}]",,0.0927706,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mortimer', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: Kevin.mortimer@lstmed.ac.uk.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Lesosky', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Stirling University, Stirling, UK.'}, {'ForeName': 'Jullita', 'Initials': 'J', 'LastName': 'Malava', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Katundu', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Crampin', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Weston', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Havens', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK; Malawi Liverpool Wellcome Trust Programme, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'University of California, Berkeley, CA; University of California, San Francisco, San Francisco, CA.'}]",Chest,['10.1016/j.chest.2020.03.064']
172,32179212,"Omega-3 fatty-acids modulate symptoms of depressive disorder, serum levels of omega-3 fatty acids and omega-6/omega-3 ratio in children. A randomized, double-blind and controlled trial.","Omega-3 fatty acids (FA) are a promising adjuvant therapy for depressive disorder (DD) in adults. The objective of this single-centre, randomized, double-blind and controlled study was to compare the efficacy of an omega-3 FA fish oil emulsion with a control oil emulsion alongside the standard treatment for depression in children and adolescents suffering from DD or mixed anxiety depressive disorder (MADD) and to analyse serum fatty acid levels and omega-6/omega-3 FA ratio before and after the intervention. 60 children were randomised 1:1 to the intervention (Om3) or active comparator (Om6) groups. Children's Depression Inventory (CDI) ratings were performed at the baseline, every 2 weeks for a 12-week intervention period. Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup. Ratio of omega-6/omega-3 decreased in Om3 but not in Om6 from 24.2/1 to 7.6/1 after 6 weeks, EPA, omega-6/omega-3 ratio, but not DHA, correlated with severity symptoms at the baseline. An omega-3 fatty acid rich fish oil emulsion may be an effective adjuvant supplement during the treatment of depressive disorders in children. Trial registration: ISRCTN 81655012.",2020,Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup.,"['depressive disorder (DD) in adults', 'children and adolescents suffering from DD or mixed anxiety depressive disorder (MADD', 'children', 'depressive disorders in children', '60 children']","['omega-3 fatty acid rich fish oil emulsion', 'Omega-3 fatty-acids', 'intervention (Om3) or active comparator (Om6', 'omega-3 FA fish oil emulsion', 'Omega-3 fatty acids (FA']","[""Children's Depression Inventory (CDI) ratings"", 'serum fatty acid levels and omega-6/omega-3 FA ratio', 'Ratio of omega-6/omega-3 decreased in Om3', 'CDI scores']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1281901', 'cui_str': 'Fatty acid measurement'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.207963,Significant reductions in CDI scores were observed after 6 and 12 weeks of intervention in the Om3 group and in the DD subgroup compared to the Om6 and MADD subgroup.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Trebatická', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia. Electronic address: jana.trebaticka@fmed.uniba.sk.""}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Hradečná', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Surovcová', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Katrenčíková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Sasinkova 2, Bratislava 813 72, Slovakia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gushina', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff CF10 3AX, United Kingdom.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Waczulíková', 'Affiliation': 'Comenius University, Faculty of Mathematics, Physics and Informatics, Department of Nuclear Physics and Biophysics, Mlynská dolina F1, Bratislava 842 48, Slovakia.'}, {'ForeName': 'Katarína', 'Initials': 'K', 'LastName': 'Sušienková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Biology, Genetics and Clinical Genetics, Sasinkova 4, Bratislava 813 72, Slovakia.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Garaiova', 'Affiliation': 'Research and Development Department, Cultech Ltd., Unit 2 Christchurch Road, Port Talbot, Aberavon SA12 7BZ, United Kingdom.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Šuba', 'Affiliation': ""Comenius University, Faculty of Medicine and The National Institute of Children's Diseases, Department of Child and Adolescent Psychiatry, Limbová 1, Bratislava 833 40, Slovakia.""}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Ďuračková', 'Affiliation': 'Comenius University, Faculty of Medicine, Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Sasinkova 2, Bratislava 813 72, Slovakia.'}]",Psychiatry research,['10.1016/j.psychres.2020.112911']
173,30924578,Baseline nocturnal glucose change: A predictor of the treatment effect of bolus intensification in insulin-treated type 2 diabetes.,"This post hoc analysis of an 18-week randomized trial explored the utility of calculating baseline glycated haemoglobin (HbA1c), postprandial glucose (PPG) increments and nocturnal glucose change in predicting efficacy and safety outcomes in response to bolus insulin intensification in people with type 2 diabetes (T2D). Analyses were conducted on 236 participants with T2D receiving metformin: 116 received fast-acting insulin aspart (faster aspart) basal-bolus therapy and 120 received basal-only insulin. Participants were grouped according to baseline HbA1c, PPG increments and nocturnal glucose change variables; analyses were performed on the end-of-trial treatment differences between ""high"" and ""low"" baseline values. The change from baseline in end-of-trial mean HbA1c and mean PPG increments was in favour of faster aspart across all subgroups. Significantly greater treatment differences were observed in participants with high (vs. low) baseline nocturnal glucose change and PPG increments. For baseline HbA1c, significantly greater treatment differences were observed for change in end-of-trial PPG increments, but not end-of-trial HbA1c. In conclusion, both nocturnal glucose change and PPG increments may be more useful than HbA1c for identifying subgroups of people with T2D who would most benefit from bolus intensification.",2019,Significantly greater treatment differences were observed in participants with high (vs. low) baseline nocturnal glucose change and PPG increments.,"['people with type 2 diabetes (T2D', '236 participants with T2D receiving', 'insulin-treated type 2 diabetes']","['fast-acting insulin aspart (faster aspart) basal-bolus therapy and 120 received basal-only insulin', 'metformin']","['baseline glycated haemoglobin (HbA1c), postprandial glucose (PPG) increments and nocturnal glucose change']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",236.0,0.151023,Significantly greater treatment differences were observed in participants with high (vs. low) baseline nocturnal glucose change and PPG increments.,"[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Clinical Diabetes Program, Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Milivoj', 'Initials': 'M', 'LastName': 'Piletič', 'Affiliation': 'General Hospital, Novo Mesto, Slovenia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ejstrud', 'Affiliation': 'Novo Nordisk A/S, Aalborg, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salvesen-Sykes', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bowering', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13729']
174,32108355,Recombinant human insulin-like growth factor-1 therapy for 6 months improves growth but not motor function in boys with Duchenne muscular dystrophy.,"INTRODUCTION


Recombinant human insulin-like growth factor-1 (rhIGF-1) is a growth factor and has anabolic effects on muscle. We investigated whether rhIGF-1 therapy: 1) improves or preserves muscle function; and 2) improves growth in boys with Duchenne muscular dystrophy (DMD).
METHODS


In this study we compared prepubescent, ambulatory, glucocorticoid-treated boys with DMD (n = 17) vs controls (glucocorticoid therapy only, n = 21) in a 6-month-long, prospective, randomized, controlled trial of subcutaneous rhIGF-1 therapy. The primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included height velocity (HV), change in height standard deviation score (ΔHtSDS), motor function, cardiopulmonary function, body composition, insulin sensitivity, quality of life, and safety.
RESULTS


Change in 6MWD was similar between groups (rhIGF-1 vs controls [mean ± SD]: 3.4 ± 32.4 vs -5.1 ± 50.2 meters, P = .53). Treated subjects grew more than controls (HV: 6.5 ± 1.7 vs 3.3 ± 1.3 cm/year, P < .0001; 6-month ΔHtSDS: 0.25, P < .0001). Lean mass and insulin sensitivity increased in treated subjects.
DISCUSSION


In boys with DMD, 6 months of rhIGF-1 therapy did not change motor function, but it improved linear growth.",2020,"Treated subjects grew more than controls (HV: 6.5±1.7 vs. 3.3±1.3cm/year, p<0.0001; 6-month ∆HtSDS 0.25 SD, p<0.0001).","['prepubescent, ambulatory, glucocorticoid-treated boys with DMD (n=17) compared to controls (glucocorticoid therapy only, n=21', 'boys with Duchenne muscular dystrophy (DMD', 'boys with Duchenne Muscular Dystrophy']","['subcutaneous rhIGF-1 therapy', 'rhIGF-1 therapy', 'Recombinant human insulin-like growth factor-1 (rhIGF-1) therapy']","['6-minute walk distance (6MWD', 'linear growth', 'height velocity (HV), change in height SD (∆HtSDS), motor function, cardiopulmonary function, body composition, insulin sensitivity, quality of life, and safety', 'Lean mass and insulin sensitivity', '6MWD']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0904505', 'cui_str': 'mecasermin'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.150267,"Treated subjects grew more than controls (HV: 6.5±1.7 vs. 3.3±1.3cm/year, p<0.0001; 6-month ∆HtSDS 0.25 SD, p<0.0001).","[{'ForeName': 'Meilan M', 'Initials': 'MM', 'LastName': 'Rutter', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics and Neurology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Collins', 'Affiliation': 'Mercy Clinic Pediatric Neurology, Springfield, Missouri, USA.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Sawnani', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Taylor', 'Affiliation': ""The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ""Division of Pediatric Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Philippe F', 'Initials': 'PF', 'LastName': 'Backeljauw', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",Muscle & nerve,['10.1002/mus.26846']
175,32314132,"Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas.","BACKGROUND


Persons with severe, persistent mental illness (SPMI) are at high risk for poor health and premature mortality. Integrating primary care in a mental health center may improve health outcomes in a population with SPMI in a socioeconomically distressed region of the USA.
OBJECTIVE


To examine the effects of reverse colocated integrated care on persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border.
DESIGN


Randomized trial evaluating the effect of a reverse colocated integrated care intervention among chronically ill adults.
PARTICIPANTS


Participants were recruited at a clinic between November 24, 2015, and June 30, 2016.
INTERVENTIONS


Receipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only).
MAIN MEASURES


The primary outcome was blood pressure. Secondary outcomes included HbA1c, BMI, total cholesterol, and depressive symptoms. Sociodemographic data were collected at baseline, and outcomes were measured at baseline and 6- and 12-month follow-ups.
KEY RESULTS


A total of 416 participants were randomized to the intervention (n = 249) or usual care (n = 167). Groups were well balanced on almost all baseline characteristics. At 12 months, intent-to-treat analysis showed intervention participants improved their systolic blood pressure (β = - 3.86, p = 0.04) and HbA1c (β = - 0.36, p = 0.001) compared with usual care participants when controlling for age, sex, and other baseline characteristics. No participants withdrew from the study due to adverse effects. Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure. Older and diabetic populations differentially benefited from this intervention.
CONCLUSIONS


Colocation and integration of behavioral health and primary care improved blood pressure and HbA1c after 1-year follow-up for persons with SPMI and co-morbid chronic disease in a US-Mexico border community.
TRIAL REGISTRATION


clinicaltrials.gov , Identifier: NCT03881657.",2020,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"['Participants were recruited at a clinic between November 24, 2015, and June 30, 2016', 'chronically ill adults', 'persons with SPMI and co-morbid chronic disease in a US-Mexico border community', '416 participants', 'persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border', 'Persons with severe, persistent mental illness (SPMI', 'population with SPMI in a socioeconomically distressed region of the USA', 'Persons with Severe, Persistent Mental Illness in Southern Texas']","['reverse colocated integrated care', 'Receipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only', 'Reverse Colocated Integrated Care', 'reverse colocated integrated care intervention', 'usual care']","['adverse effects', 'blood pressure', 'health outcomes', 'HbA1c, BMI, total cholesterol, and depressive symptoms', 'blood pressure and HbA1c', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",416.0,0.130521,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"[{'ForeName': 'Karen Sautter', 'Initials': 'KS', 'LastName': 'Errichetti', 'Affiliation': 'Department of Movement Arts, Health Promotion and Leisure Studies, Bridgewater State University, 325 Plymouth Street, Bridgewater, MA, 02325, USA. ksautter@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Gaitan', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'M Marlen', 'Initials': 'MM', 'LastName': 'Ramirez', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05778-2']
176,32314290,The effect of Zataria multiflora on inflammatory cytokine and respiratory symptoms in veterans exposed to sulfur mustard.,"The effect of Zataria multiflora (Z. multiflora) on serum cytokine, chemokines, and respiratory symptoms in the veterans exposed to sulfur mustard (SM) more than two decades (27-30 years) ago was conducted in 2018. Thirty-four patients were randomly assigned to the placebo group (P, mean age (54.40 ± 5.51)) and two treated groups with Z. multiflora extract 5 and 10 mg/kg/day (Z5 and 10; mean age, 58.50 ± 3.60 and 55.18 ± 4.11, respectively). Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively). The value of FEV 1  was significantly increased in Z10 in phase I and II compared with that in phase 0 (p < 0.01 for both) and in Z5 in phase II compared with phase I and 0 (p < 0.001for both). All respiratory symptoms significantly decreased in Z5 and 10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). Serum levels of TNF-α and VEGF were decreased in Z5 and 10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). Serum levels of MCP-1 and EGF were decreased in Z10 in phase I and II compared with those in phase 0 (p < 0.05 to p < 0.001). The percent change of respiratory symptoms, serum levels of cytokines during the treatment period, was significantly improved in the treated groups compared with that in the placebo group. Two months' of treatment with Z. multiflora improved cytokine levels, respiratory symptom, and FEV 1  values in SM-exposed patients.",2020,"Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively).","['veterans exposed to sulfur mustard (SM) more than two decades (27-30\xa0years) ago was conducted in 2018', 'Thirty-four patients', 'veterans exposed to sulfur mustard']","['Zataria multiflora', 'Zataria multiflora (Z. multiflora', 'placebo']","['value of FEV 1', 'cytokine levels, respiratory symptom, and FEV 1  values', 'respiratory symptoms, serum levels of cytokines', 'inflammatory cytokine and respiratory symptoms', 'serum cytokine, chemokines, and respiratory symptoms', 'All respiratory symptoms', 'Serum levels of TNF-α and VEGF', 'Serum levels of MCP-1 and EGF', 'Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026874', 'cui_str': 'Mustard gas'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",34.0,0.0320334,"Serum levels of tumor necrosis factor (TNF-α), monocyte chemotactic protein 1 (MCP-1), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), forced expiratory volume-one second (FEV 1 ), and respiratory symptoms including chest wheeze (CW), night wheeze (NW), night cough (NC), and cough and wheeze during exercise (ECW) were assessed at the baseline (phase 0), 1 and 2 months after starting treatment (phase I and II, respectively).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khazdair', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Rezaeetalab', 'Affiliation': 'COPD Research Center, Department of Internal Medicine, Imam-Reza Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Rafatpanah', 'Affiliation': 'Department of Immunology, Immunology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, 9177948564, Iran. boskabadymh@mums.ac.ir.'}]",Environmental science and pollution research international,['10.1007/s11356-020-08855-5']
177,31796986,"GLP-1 secretion is regulated by IL-6 signalling: a randomised, placebo-controlled study.","AIMS/HYPOTHESIS


IL-6 is a cytokine with various effects on metabolism. In mice, IL-6 improved beta cell function and glucose homeostasis via upregulation of glucagon-like peptide 1 (GLP-1), and IL-6 release from muscle during exercise potentiated this beneficial increase in GLP-1. This study aimed to identify whether exercise-induced IL-6 has a similar effect in humans.
METHODS


In a multicentre, double-blind clinical trial, we randomly assigned patients with type 2 diabetes or obesity to intravenous tocilizumab (an IL-6 receptor antagonist) 8 mg/kg every 4 weeks, oral sitagliptin (a dipeptidyl peptidase-4 inhibitor) 100 mg daily or double placebos (a placebo saline infusion every 4 weeks and a placebo pill once daily) during a 12 week training intervention. The primary endpoints were the difference in change of active GLP-1 response to an acute exercise bout and change in the AUC for the concentration-time curve of active GLP-1 during mixed meal tolerance tests at baseline and after the training intervention.
RESULTS


Nineteen patients were allocated to tocilizumab, 17 to sitagliptin and 16 to placebos. During the acute exercise bout active GLP-1 levels were 26% lower with tocilizumab (multiplicative effect: 0.74 [95% CI 0.56, 0.98], p = 0.034) and 53% higher with sitagliptin (1.53 [1.15, 2.03], p = 0.004) compared with placebo. After the 12 week training intervention, the active GLP-1 AUC with sitagliptin was about twofold that with placebo (2.03 [1.56, 2.62]; p < 0.001), while GLP-1 AUC values showed a small non-significant decrease of 13% at 4 weeks after the last tocilizumab infusion (0.87 [0.67, 1.12]; p = 0.261).
CONCLUSIONS/INTERPRETATION


IL-6 is implicated in the regulation of GLP-1 in humans. IL-6 receptor blockade lowered active GLP-1 levels in response to a meal and an acute exercise bout in a reversible manner, without lasting effects beyond IL-6 receptor blockade.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01073826.
FUNDING


Danish National Research Foundation. Danish Council for Independent Research. Novo Nordisk Foundation. Danish Centre for Strategic Research in Type 2 Diabetes. European Foundation for the Study of Diabetes. Swiss National Research Foundation.",2020,IL-6,"['Nineteen patients', 'patients with type 2 diabetes or obesity to intravenous']","['exercise-induced IL-6', 'IL-6', 'double placebos (a placebo saline', 'tocilizumab (an IL-6 receptor antagonist) 8\xa0mg/kg every 4\xa0weeks, oral sitagliptin (a dipeptidyl peptidase-4 inhibitor', 'placebo', 'tocilizumab', 'placebos']","['active GLP-1 AUC with sitagliptin', 'GLP-1 AUC values', 'beta cell function and glucose homeostasis via upregulation of glucagon-like peptide 1 (GLP-1), and IL-6 release', 'GLP-1 secretion', 'acute exercise bout active GLP-1 levels', 'change of active GLP-1 response to an acute exercise bout and change in the AUC for the concentration-time curve of active GLP-1 during mixed meal tolerance tests']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}]",,0.710886,IL-6,"[{'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark. Helga.Ellingsgaard@regionh.dk.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Seelig', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Timper', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Department of Clinical Research, CTU, University of Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Soederlund', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbaek', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Schmidt-Trucksäss', 'Affiliation': 'Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Walter O', 'Initials': 'WO', 'LastName': 'Frey', 'Affiliation': 'Balgrist MoveMed, Swiss Olympic Medical Center, University Hospital Balgrist, Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism (CIM)/ Centre for Physical Activity Research (CFAS), Rigshospitalet 7641, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Böni-Schnetzler', 'Affiliation': 'Department Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marc Y', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolism University Hospital Basel, Basel, Switzerland.'}]",Diabetologia,['10.1007/s00125-019-05045-y']
178,30666700,Effects of the nitric oxide synthase inhibitor ronopterin (VAS203) on renal function in healthy volunteers.,"AIMS


Reduced nitric oxide (NO) availability may adversely affect renal perfusion and glomerular filtration. The aim of the present study was to characterize in detail the pharmacological effects of VAS203, an inhibitor of NO synthase, on renal haemodynamics in humans.
METHODS


This double-blind, randomized, placebo-controlled, cross-over phase-I-study comprised 18 healthy men. Renal haemodynamics were assessed with constant-infusion input-clearance technique with p-aminohippurate and inulin for renal plasma flow (RPF) and glomerular filtration rate (GFR), respectively. After baseline measurement, a constant infusion of the tetrahydrobiopterin analogue ronopterin (VAS203, total 10 mg/kg body weight) or placebo was administered at random order for 6 hours additionally. After a wash-out phase of 28 days, the second course was applied. In parallel, markers of early kidney injury and renal function were assessed repeatedly up to 48 hours after starting VAS203/placebo-infusion.
RESULTS


VAS203-infusion resulted in a significant decrease of RPF (P < .0001) and GFR (P < .001) compared to placebo, but magnitude was within the physiological range. RPF and GFR recovered partly 2 hours after end of VAS203-infusion and was normal at beginning of the second infusion period. Compared to placebo, preglomerular resistance (P < .0001), and to lesser extent postglomerular resistance (P < .0001) increased, resulting in a decrease of intraglomerular pressure (P < .01). No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
CONCLUSIONS


Our phase-I-study in healthy humans indicates that VAS203 (10 mg/kg body weight) reduces renal perfusion and glomerular function within the physiological range mainly due to vasoconstriction at the preglomerular site.",2019,"No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
","['healthy humans', 'humans', '18 healthy men', 'healthy volunteers']","['VAS203', 'nitric oxide synthase inhibitor ronopterin (VAS203', 'placebo']","['renal plasma flow (RPF) and glomerular filtration rate (GFR', 'intraglomerular pressure', 'Renal haemodynamics', 'markers of early kidney injury, and on renal function', 'renal perfusion and glomerular function', 'renal perfusion and glomerular filtration', 'GFR', 'renal function', 'RPF and GFR', 'early kidney injury and renal function', 'RPF']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4045572', 'cui_str': 'VAS203'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0206087', 'cui_str': 'Renal Plasma Flow'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}]",18.0,0.370135,"No treatment related effect on markers of early kidney injury, and on renal function (P for all >.20) have been observed.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Winzer', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Schinzel', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tegtmeier', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.13870']
179,32103542,Randomized Controlled Trial of a Web-Based Intervention to Disseminate Clinical Practice Guidelines for Posttraumatic Stress Disorder: The PTSD Clinicians Exchange.,"Delivery of best-practice care for posttraumatic stress disorder (PTSD) is a priority for clinicians working with active duty military personnel and veterans. The PTSD Clinicians Exchange, an Internet-based intervention, was designed to assist in disseminating clinically relevant information and resources that support delivery of key practices endorsed in the Veterans Administration (VA)-Department of Defense (DoD) Clinical Practice Guidelines (CPG) for the Management of Posttraumatic Stress. We conducted a randomized controlled trial to examine the effectiveness of the Clinicians Exchange intervention in increasing familiarity and perceived benefits of 26 CPG-related and emerging practices. The intervention consisted of ongoing access to an Internet resource featuring best-in-class resources for practices, self-management of burnout, and biweekly e-mail reminders highlighting selected practices. Mental health clinicians (N = 605) were recruited from three service sectors (VA, DoD, community); 32.7% of participants assigned to the Internet intervention accessed the site to view resources. Individuals who were offered the intervention increased their practice familiarity ratings significantly more than those assigned to a newsletter-only control condition, d = 0.27, p = .005. From baseline to 12-months, mean familiarity ratings of clinicians in the intervention group increased from 3.0 to 3.4 on scale of 1 (not at all) to 5 (extremely); mean ratings for the control group were 3.2 at both assessments. Clinicians generally viewed the CPG practices favorably, rating them as likely to benefit their clients. The results suggest that Internet-based resources may aid more comprehensive efforts to disseminate CPGs, but increasing clinician engagement will be important.",2020,"Individuals who were offered the intervention increased their practice familiarity ratings significantly more than those assigned to a newsletter-only control condition, d = 0.27, p = .005.","['posttraumatic stress disorder (PTSD', 'Mental health clinicians (N = 605', 'Posttraumatic Stress Disorder', 'clinicians working with active duty military personnel and veterans']","['ongoing access to an Internet resource featuring best-in-class resources for practices, self-management of burnout, and biweekly e-mail reminders highlighting selected practices', 'Web-Based Intervention', 'Clinicians Exchange intervention']","['mean familiarity ratings of clinicians', 'practice familiarity ratings']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}]",605.0,0.0677328,"Individuals who were offered the intervention increased their practice familiarity ratings significantly more than those assigned to a newsletter-only control condition, d = 0.27, p = .005.","[{'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, Menlo Park, California, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Wilk', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, Menlo Park, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, Menlo Park, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ambrosoli', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Zincavage', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Clarke-Walper', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Penix', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., Watertown, Massachusetts, USA.'}]",Journal of traumatic stress,['10.1002/jts.22483']
180,31788783,Third-trimester prediction of successful vaginal birth after one cesarean delivery-A Swedish model.,"INTRODUCTION


The objective was to create a clinically useful prediction model for vaginal birth in trial of labor after one cesarean section, appropriate for a third trimester consultation.
MATERIAL AND METHODS


Women with one cesarean section and at least one following delivery (N = 38 686) in the Swedish Medical Birth Register, 1998-2013, were studied. The women were randomly divided into one development and one validation data set. From the development data set, variables associated with vaginal birth after cesarean (VBAC) were identified by univariable logistic regression. Stepwise backward selection was performed until all variables were statistically significant. From the final fitted multivariable logistic model, likelihood ratios were calculated, in order to transpose odds ratios into clinically useful measurements. A constant, based on the delivery ward VBAC in trial of labor rate, was used. By applying the likelihood ratios on the validation data set, the VBAC chance for each woman was estimated with the Bayesian theorem, and the ability of the model to predict VBAC was explored using receiver operating characteristics (ROC) curves.
RESULTS


A previous VBAC, and a previous cesarean section for non-cephalic presentation, were the strongest VBAC predictors. The lowest chances were found for a previous cesarean section due to dystocia, and among women with <18 months since the last cesarean section. The area under the ROC curve was 0.67.
CONCLUSIONS


The new model was satisfactory in predicting VBAC in trial of labor. Developed as a software application, it would become a clinically useful decision-aid.",2020,"The lowest chances were found for a previous cesarean section due to dystocia, and among women with <18 months since last cesarean section.","['Women with one cesarean section and at least one following delivery (N=38 686) in the Swedish Medical Birth Register, 1998-2013, were studied']",[],"['vaginal birth after cesarean (VBAC', 'successful vaginal birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0080301', 'cui_str': 'Vaginal Birth after Cesarean'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",,0.0244142,"The lowest chances were found for a previous cesarean section due to dystocia, and among women with <18 months since last cesarean section.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Carlsson Fagerberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Ystad Hospital, Ystad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Källén', 'Affiliation': 'Clinical Sciences, Department of Obstetrics and Gynecology, University of Lund, Lund, Sweden.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13783']
181,30869183,"Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial.","AIMS


To assess the efficacy and safety of twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both ± metformin, in Chinese adults (N = 543) with type 2 diabetes (T2D) inadequately controlled on premixed/self-mixed or basal insulin ± metformin.
MATERIALS AND METHODS


We conducted a 26-week, phase III, open-label, treat-to-target, 2:1 randomized trial. Hierarchical testing was used with non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 26 as the primary endpoint and superiority for the confirmatory secondary endpoints which were as follows: change from baseline in fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes (12:01-5:59 am, inclusive); total confirmed hypoglycaemic episodes (severe or plasma glucose <3.1 mmol/L with/without symptoms); body weight; and percentage of responders (HbA1c <53 mmol/mol [<7.0%]) without confirmed hypoglycaemic episodes.
RESULTS


Non-inferiority for change from baseline to week 26 in HbA1c and superiority of IDegAsp twice daily versus BIAsp 30 twice daily for change in FPG, nocturnal confirmed and total confirmed hypoglycaemic episodes, was demonstrated. Estimated rates of nocturnal confirmed and total confirmed hypoglycaemic episodes were 47% and 43% lower, respectively, with IDegAsp twice daily versus BIAsp 30 twice daily. Superiority for change in body weight was not confirmed. Participants were more likely to reach the HbA1c goal of <53 mmol/mol (<7.0%) without confirmed hypoglycaemia with IDegAsp twice daily versus BIAsp 30 twice daily by trial end. No new safety signals were identified.
CONCLUSIONS


The efficacy and safety of IDegAsp in Chinese patients with T2D was demonstrated, confirming results from international trials.",2019,Hierarchical testing was used with non-inferiority of glycated haemoglobin,"['Chinese adults with type 2 diabetes', 'Chinese patients with T2D', 'Chinese adults (N\u2009=\u2009543) with type 2 diabetes (T2D) inadequately controlled on']","['twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both ± metformin', 'premixed/self-mixed or basal insulin ± metformin', 'insulin degludec/insulin aspart versus biphasic insulin aspart 30']","['efficacy and safety of IDegAsp', 'Estimated rates of nocturnal confirmed and total confirmed hypoglycaemic episodes', 'glycated haemoglobin', 'hypoglycaemic episodes (severe or plasma glucose', 'fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes', 'Efficacy and safety', 'efficacy and safety', 'body weight']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C2003521', 'cui_str': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",543.0,0.117463,Hierarchical testing was used with non-inferiority of glycated haemoglobin,"[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Tianpei', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Shanghai First People's Hospital, Shanghai, China.""}, {'ForeName': 'Changjiang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Province Hospital, Jiangsu, China.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Nielsen', 'Affiliation': 'Medical & Science Degludec Portfolio, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Novo Nordisk (China) Pharmaceuticals Co. Ltd, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Novo Nordisk (China) Pharmaceuticals Co. Ltd, Beijing, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13703']
182,32012251,"A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects.","OBJECTIVE


The pharmacokinetics (PK) and safety of single oral 750-mg doses of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the USA and Epidyolex in Europe; 100-mg/mL oral solution) were assessed in healthy adults following a high-fat/calorie meal (n = 15), a low-fat/calorie meal (n = 14), whole milk (n = 15), or alcohol (n = 14), relative to the fasted state (n = 29).
METHODS


Blood samples were collected until 96 hours postdose in each period and evaluated by liquid chromatography and tandem mass spectrometry. PK parameters (maximum observed plasma concentration [C max  ], area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration, area under the concentration-time curve from time zero to infinity [AUC 0-∞  ], and time to maximum plasma concentration [t max  ]) of CBD and its major metabolites were derived using noncompartmental analysis.
RESULTS


CBD exposure increased by 3.8-fold for AUC 0-∞  and 5.2-fold for C max  when CBD was administered with a high-fat/calorie meal versus fasted. To a lesser extent, a low-fat/calorie meal enhanced CBD exposure versus fasted with a 2.7-fold increase in AUC 0-∞  and a 3.8-fold increase in C max  . Similarly, when dosed with whole milk, CBD exposure increased versus fasted by 2.4-fold for AUC 0-∞  and 3.1-fold for C max  . Modest elevations in CBD exposure occurred when it was dosed with alcohol: 1.6-fold for AUC 0-∞  and 1.9-fold for C max  . No clinically relevant effect of any test condition on CBD t max  or t ½  versus the fasted state was apparent. The same trend was seen for the CBD metabolites, except that 7-carboxy-cannabidiol t max  was considerably longer when CBD was administered with alcohol (14 vs 4 hours fasted). Inter- and intrasubject variability in PK parameters was moderate to high during the trial.
SIGNIFICANCE


CBD and metabolite exposures were most affected by a high-fat/calorie meal. CBD exposures also increased with a low-fat/calorie meal, whole milk, or alcohol, but to a lesser extent. CBD was tolerated, and there were no severe or serious adverse events during the trial.",2020,No clinically relevant effect of any test condition on CBD t max  or t ½  versus the fasted state was apparent.,"['healthy subjects', 'healthy adults following a high-fat/calorie meal (n\xa0=\xa015), a low-fat/calorie meal (n\xa0=\xa014), whole milk (n\xa0=\xa015), or alcohol (n\xa0=\xa014), relative to the fasted state (n\xa0=\xa029']","['alcohol', 'CBD', 'meal compositions, whole milk, and alcohol']","['severe or serious adverse events', 'CBD exposures', 'CBD exposure', 'PK parameters (maximum observed plasma concentration [C max  ], area under the plasma concentration-time curve', 'time to maximum plasma concentration [t max  ]) of CBD and its major metabolites', 'CBD metabolites']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0452717', 'cui_str': 'Whole milk (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0452717', 'cui_str': 'Whole milk (substance)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0351745,No clinically relevant effect of any test condition on CBD t max  or t ½  versus the fasted state was apparent.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Berwaerts', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}]",Epilepsia,['10.1111/epi.16419']
183,31692016,Sex-based differences in the response to dexamethasone in bacterial meningitis: Analysis of the European dexamethasone in adulthood bacterial meningitis study.,"Inflammatory markers have been found at higher concentrations in women than men with bacterial meningitis. To investigate sex-based differences in the response to dexamethasone, we performed a post hoc analysis of a double-blind, randomised multicentre trial of dexamethasone (10 mg, 4 times daily for 4 days) vs placebo in adults with bacterial meningitis. The primary outcome measure was the Glasgow outcome scale score at 8 weeks and interaction tests were used to examine subgroup differences. Between June 1993 and December 2001, 301 patients (56% male) were randomly assigned to a treatment group: 157 received dexamethasone and 144 placebo. Although dexamethasone reduced the risk of unfavourable outcome to a greater extent in women (relative risk [RR] 0.42, 95% confidence interval [CI] 0.21-0.86, P = .02) than men (RR 0.79, 95% CI 0.41-1.51, P = .55), on interaction testing (ratio of RR women:men 0.53, 95% CI 0.20-1.39, P = .19) patient sex was not a significant modifier of the effect of dexamethasone.",2020,"Although dexamethasone reduced the risk of unfavourable outcome to a greater extent in women (relative risk [RR] 0.42, 95% confidence interval [CI] 0.21-0.86, p=0.02) than men (RR 0.79, 95% CI 0.41-1.51, p=0.55), on interaction testing (ratio of RR women:men 0.53, 95% CI 0.20-1.39, p=0.19) patient sex was not a significant modifier of the effect of dexamethasone.","['Between June 1993-December 2001, 301 patients (56% male', 'women than men with bacterial meningitis', 'adults with bacterial meningitis']","['placebo', 'dexamethasone', 'dexamethasone and 144 placebo', 'European dexamethasone']",['Glasgow Outcome Scale score'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085437', 'cui_str': 'Meningitis, Bacterial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}]","[{'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",301.0,0.700504,"Although dexamethasone reduced the risk of unfavourable outcome to a greater extent in women (relative risk [RR] 0.42, 95% confidence interval [CI] 0.21-0.86, p=0.02) than men (RR 0.79, 95% CI 0.41-1.51, p=0.55), on interaction testing (ratio of RR women:men 0.53, 95% CI 0.20-1.39, p=0.19) patient sex was not a significant modifier of the effect of dexamethasone.","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Dias', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthijs C', 'Initials': 'MC', 'LastName': 'Brouwer', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'van de Beek', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14163']
184,32305099,"Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial.","BACKGROUND


State-of-the art therapy for recurrent ovarian cancer suitable for platinum-based re-treatment includes bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine) or the most active non-bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin. The aim of this head-to-head trial was to compare a standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab.
METHODS


This multicentre, open-label, randomised, phase 3 trial, was done in 159 academic centres in Germany, France, Australia, Austria, and the UK. Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2. Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language, and were centrally randomly assigned 1:1 using randomly permuted blocks of size two, four, or six to receive six intravenous cycles of bevacizumab (15 mg/kg, day 1) plus carboplatin (area under the concentration curve [AUC] 4, day 1) plus gemcitabine (1000 mg/m 2 , days 1 and 8) every 3 weeks or six cycles of bevacizumab (10 mg/kg, days 1 and 15) plus carboplatin (AUC 5, day 1) plus pegylated liposomal doxorubicin (30 mg/m 2 , day 1) every 4 weeks, both followed by maintenance bevacizumab (15 mg/kg every 3 weeks in both groups) until disease progression or unacceptable toxicity. There was no masking in this open-label trial. The primary endpoint was investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1. Efficacy data were analysed in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug. This completed study is registered with ClinicalTrials.gov, NCT01837251.
FINDINGS


Between Aug 1, 2013, and July 31, 2015, 682 eligible patients were enrolled, of whom 345 were randomly assigned to receive carboplatin-pegylated liposomal doxorubicin-bevacizumab (experimental group) and 337 were randomly assigned to receive carboplatin-gemcitabine-bevacizumab (standard group). Median follow-up for progression-free survival at data cutoff (July 10, 2018) was 12·4 months (IQR 8·3-21·7) in the experimental group and 11·3 months (8·0-18·4) in the standard group. Median progression-free survival was 13·3 months (95% CI 11·7-14·2) in the experimental group versus 11·6 months (11·0-12·7) in the standard group (hazard ratio 0·81, 95% CI 0·68-0·96; p=0·012). The most common grade 3 or 4 adverse events were hypertension (88 [27%] of 332 patients in the experimental group vs 67 [20%] of 329 patients in the standard group) and neutropenia (40 [12%] vs 73 [22%]). Serious adverse events occurred in 33 (10%) of 332 patients in the experimental group and 28 (9%) of 329 in the standard group. Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
INTERPRETATION


Carboplatin-pegylated liposomal doxorubicin-bevacizumab is a new standard treatment option for platinum-eligible recurrent ovarian cancer.
FUNDING


F Hoffmann-La Roche.",2020,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
","['Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language', '159 academic centres in Germany, France, Australia, Austria, and the UK', 'Between Aug 1, 2013, and July 31, 2015', '682 eligible patients were enrolled, of whom 345', 'recurrent ovarian cancer', 'platinum-eligible recurrent ovarian cancer', 'Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2']","['doxorubicin ', 'Carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'gemcitabine', 'carboplatin', 'bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin', 'bevacizumab', 'Bevacizumab and platinum-based combinations', 'carboplatin-gemcitabine-bevacizumab', 'bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine', 'standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab', 'carboplatin (AUC 5, day 1) plus pegylated liposomal']","['large intestine perforation', 'osmotic demyelination syndrome and intracranial haemorrhage', 'Safety', 'neutropenia', 'Serious adverse events', 'deaths', 'Median progression-free survival', 'investigator-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C0151738', 'cui_str': 'Perforation of large intestine'}, {'cui': 'C2721559', 'cui_str': 'Osmotic demyelination syndrome'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",682.0,0.197238,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
","[{'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': 'Gynaecologic Oncology Center, Kiel, Germany. Electronic address: jacobus.pfisterer@googlemail.com.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Shannon', 'Affiliation': 'Oncology Department, Mater Cancer Care Centre, Brisbane, QLD, Australia.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Baumann', 'Affiliation': 'Gynaecology Department, Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Gynaecology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynaecology, and European Competence Center for Ovarian Cancer, Charité - Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'Department of Gynaecology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Technical University of Munich-Klinikum Rechts der Isar, Germany; Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Dean', 'Affiliation': 'Gynaecological Oncology Department, St John of God Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hein', 'Affiliation': 'Gynaecology Department, Erlangen University Hospital, Erlangen, Germany.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Zeimet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Gynaecology Department, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Paul Strauss Cancer Center and Gynaecology Department, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Gynaecology Department, National Center for Tumor Disease, University of Heidelberg, Heidelberg, Germany; Department of Gynaecology and Obstetrics, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Balat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Frankfurt/Main, Frankfurt, Germany.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Glasspool', 'Affiliation': 'National Cancer Research Institute, Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Obstetrics and Gynaecology, University Hospital, Ludwig-Maximilian-University, Munich, Germany.'}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Meniawy', 'Affiliation': 'Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, Hannover, Germany.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Costan', 'Affiliation': 'Department of Oncology, Hôpital Michallon, Grenoble, France.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Gynaecology and Obstetrics, Evangelisches Krankenhaus Düsseldorf, Germany; Department of Gynaecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Comprehensive Cancer Centre, University Hospital for Gynaecology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Tifenn', 'Initials': 'T', 'LastName': ""L'Haridon"", 'Affiliation': 'Centre Hospitalier Départemental les Oudairies, La Roche-Sur-Yon, France.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Baron Hay', 'Affiliation': ""Women's Health, Royal North Shore Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': ""Department of Women's Health, Tübingen University Hospital, Tübingen, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kurtz', 'Affiliation': 'Haematology-Oncology Department, Centre Hospitalier Régional et Universitaire de Strasbourg Hôpital Civil, Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30142-X']
185,31811650,Randomized controlled trial of a clinical decision support system for painful polyneuropathy.,"INTRODUCTION


Despite the existence of guidelines, painful neuropathy is often inappropriately treated. We sought to determine the effectiveness of a clinical decision support system on guideline-recommended medication use.
METHODS


We randomized neurology providers, stratified by subspecialty, to a best practice alert (BPA) linked to a Smartset or a BPA alone when seeing patients with neuropathy. The primary outcome was the proportion of patients with uncontrolled nerve pain prescribed a guideline-recommended medication. Generalized estimating equations were used to assess effectiveness.
RESULTS


Seventy-five neurology providers (intervention 38, control 37) treated 2697 patients with neuropathy (intervention 1026, control 671). Providers did not acknowledge the BPA in 1928 (71.5%) visits. Only four of eight intervention arm neurologists who treated patients with uncontrolled nerve pain opened the Smartset. The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
DISCUSSION


Our intervention did not improve prescribing practices for painful neuropathy. Physicians typically ignored the BPAs/Smartset; therefore, future studies should mandate their use or employ alternate strategies.",2020,"The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
","['painful polyneuropathy', 'Seventy-five neurology providers (intervention 38, control 37) treated 2697 patients with neuropathy (intervention 1026, control 671']",[],['proportion of patients with uncontrolled nerve pain prescribed a guideline-recommended medication'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751372', 'cui_str': 'Nerve Pain'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",2697.0,0.0495132,"The intervention was not associated with guideline-recommended medication use (odds ratio 0.52, 0.18-1.48; intervention 52%, control 54.8%).
","[{'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Reynolds', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Burke', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mousumi', 'Initials': 'M', 'LastName': 'Banerjee', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Callaghan', 'Affiliation': 'Health Services Research Program, Department of Neurology, University of Michigan, Ann Arbor, Michigan.'}]",Muscle & nerve,['10.1002/mus.26774']
186,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
187,32306076,"Tumor infiltrating lymphocytes as adjuvant treatment in stage III melanoma patients with only one invaded lymph node after complete resection: results from a multicentre, randomized clinical phase III trial.","BACKGROUND


Adoptive tumor-infiltrating lymphocytes (TIL) therapy and interleukin-2 (IL-2) have been investigated in melanoma.
AIM


To confirm previously observed preventive effects of TIL + IL2 in a subgroup of patients with relapsing metastatic stage III melanoma.
METHODOLOGY


Open-label, randomized two-group, multicenter five-year trial in adult stage III melanoma patients with only one invaded lymph node after complete resection. Patients received TIL + IL2 or abstention. TIL + IL2 was administered within 8 weeks after lymph node resection and 4 weeks after. Disease-free survival was assessed every 2 months up to month 18, every 3 months up to month 36 and every 4 months up to 5 years. A once-a-year follow-up was scheduled beyond the five-year follow-up. Safety was assessed throughout the trial.
RESULTS


Overall, 49 patients accounted for the modified intent-to-treat and 47 for the PP. Slightly more male than female patients participated; mean age was 57.7 ± 11.4 years in the TIL + IL2 group and 53.5 ± 13.0 years in the abstention group. After 5 years of follow-up, 11/26 patients in the TIL + IL2 group and 13/23 in the abstention group had relapsed. There was no statistical difference between the groups (HR: 0.63 CI 95% [0.28-1.41], p = 0.258), nine patients in the TIL + IL2 and 11 in the abstention group died with no significant difference between the two groups (HR: 0.65 CI95% [0.27 - 1.59], p = 0.34). Safety was good.
CONCLUSION


We did not confirm results of a previous trial. However, ulceration of the primary melanoma may be considered predictive of the efficacy of TIL in melanoma in adjuvant setting, in a manner similar to interferon α.",2020,"There was no statistical difference between the groups (HR: 0.63 CI 95% [0.28-1.41], p = 0.258), nine patients in the TIL + IL2 and 11 in the abstention group died with no significant difference between the two groups (HR: 0.65 CI95% [0.27 - 1.59], p = 0.34).","['stage III melanoma patients with only one invaded lymph node after complete resection', 'patients with relapsing metastatic stage III melanoma', 'Slightly more male than female patients participated; mean age was 57.7\u2009±\u200911.4\xa0years in the TIL\u2009+\u2009IL2 group and 53.5\u2009±', 'adult stage III melanoma patients with only one invaded lymph node after complete resection']","['Adoptive tumor-infiltrating lymphocytes (TIL) therapy and interleukin-2 (IL-2', 'TIL\u2009+\u2009IL2', 'TIL\u2009', 'TIL\u2009+\u2009IL2 or abstention']","['Disease-free survival', 'Safety']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.119467,"There was no statistical difference between the groups (HR: 0.63 CI 95% [0.28-1.41], p = 0.258), nine patients in the TIL + IL2 and 11 in the abstention group died with no significant difference between the two groups (HR: 0.65 CI95% [0.27 - 1.59], p = 0.34).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khammari', 'Affiliation': 'Dermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Nguyen', 'Affiliation': 'SEME, PHU11, Saint-Jacques Hospital, CRCINA, INSERM, University of Nantes, Nantes, France.'}, {'ForeName': 'Marie-Thérèse', 'Initials': 'MT', 'LastName': 'Leccia', 'Affiliation': 'Department of Dermatology, Allergology and Photobiology, CHU A Michallon, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guillot', 'Affiliation': 'Département of Dermatology, University of Montpellier, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Saiagh', 'Affiliation': 'UTCG, CHU Nantes, Nantes, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Pandolfino', 'Affiliation': 'UTCG, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne-Chantal', 'Initials': 'AC', 'LastName': 'Knol', 'Affiliation': 'CRCINA, INSERM, University of Angers, University of Nantes, Nantes, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Quéreux', 'Affiliation': 'Dermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffolettau', 'Affiliation': 'Pharmacovigilance Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Labarrière', 'Affiliation': 'CRCINA, INSERM, University of Angers, University of Nantes, Nantes, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Dermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France. brigitte.dreno@atlanmed.fr.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02572-1']
188,31922613,Rituximab in refractory chronic inflammatory demyelinating polyneuropathy.,"INTRODUCTION


Chronic inflammatory demyelinating polyneuropathy (CIDP) is a disorder in which early effective treatment is important to minimize disability from axonal degeneration. It has been suggested that some patients with CIDP may benefit from rituximab therapy, but there is no definitive evidence for this.
METHODS


Baseline and post-rituximab-therapy neuromuscular Medical Research Council (MRC) sum scores, Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, and functional status were assessed in 11 patients with refactory CIDP.
RESULTS


The MRC sum score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
DISCUSSION


Our study provides evidence of the efficacy of rituximab therapy in at least some patients with CIDP. A placebo-controlled study to assess the effectiveness of rituximab therapy in CIDP with and without nodal antibodies is required to identify disease markers that predict responsiveness.",2020,"The MRC score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
","['11 patients with intractable CIDP', 'Chronic inflammatory demyelinating polyneuropathy (CIDP', 'refractory chronic inflammatory demyelinating polyneuropathy', 'patients with CIDP']","['rituximab therapy', 'placebo', 'Rituximab']","['scores (MRC), Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores, and functional status', 'MRC score, INCAT disability score, and functional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}]","[{'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0270933', 'cui_str': 'Inflammatory neuropathy (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.101734,"The MRC score, INCAT disability score, and functional status improved in all patients after rituximab therapy.
","[{'ForeName': 'Suraj A', 'Initials': 'SA', 'LastName': 'Muley', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Parry', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Usman', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Ortega', 'Affiliation': ""Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Varon', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}]",Muscle & nerve,['10.1002/mus.26804']
189,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
190,31734103,"Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial.","BACKGROUND


More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobamate in patients with uncontrolled focal (partial)-onset epilepsy.
METHODS


We did a multicentre, double-blind, randomised, placebo-controlled, dose-response study at 107 epilepsy and neurology centres in 16 countries. Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs were randomly assigned (1:1:1:1) via an interactive web response system, by block sizes of 4 within each country, to adjuvant once daily oral cenobamate at dose groups of 100 mg, 200 mg, or 400 mg, or placebo following an 8-week baseline assessment. Patients, investigators, and study personnel were masked to treatment assignment. The study included a 6-week titration phase and 12-week maintenance phase. The primary efficacy outcomes were percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures) from baseline analysed in the modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates (≥50% reduction) analysed in the maintenance phase population (≥1 dose in the maintenance phase and any maintenance phase seizure data). The primary efficacy outcomes were analysed using a hierarchal step-down procedure comparing 200 mg versus placebo, 400 mg versus placebo, then 100 mg versus placebo. Safety and tolerability were compared descriptively across treatment groups for all randomised patients. This study is registered with ClinicalTrials.gov, number NCT01866111.
FINDINGS


Between July 31, 2013, and June 22, 2015, 437 patients were randomly assigned to either placebo (n=108) or cenobamate 100 mg (n=108), 200 mg (n=110), or 400 mg (n=111). Of these patients, 434 (106 [98%] in placebo group, 108 [100%] in 100 mg group, 109 [99%] in 200 mg group, and 111 [100%] in 400 mg group) were included in the modified intention-to-treat population, and 397 (102 [94%] in placebo group, 102 [94%] in 100 mg group, 98 [89%] in 200 mg group, and 95 [86%] in 400 mg group) were included in the modified intention-to-treat maintenance phase population. Median percentage changes in seizure frequency were -24·0% (IQR -45·0 to -7·0%) for the placebo group compared with -35·5% (-62·5 to -15·0%; p=0·0071) for the 100 mg dose group, -55·0% (-73·0 to -23·0%; p<0·0001) for the 200 mg dose group, and -55·0% (-85·0 to -28·0%; p<0·0001) for the 400 mg dose group. Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group. Treatment-emergent adverse events occurred in 76 (70%) of 108 patients in the placebo group, 70 (65%) of 108 in the 100 mg group, 84 (76%) of 110 in the 200 mg group, and 100 (90%) of 111 in the 400 mg group. Treatment-emergent adverse events led to discontinuation in five (5%) patients in the placebo group, 11 (10%) in the 100 mg dose group, 15 (14%) in the 200 mg dose group, and 22 (20%) in the 400 mg dose group. One serious case of drug reaction with eosinophilia and systemic symptoms occurred in the 200 mg cenobamate group. No deaths were reported.
INTERPRETATION


Adjunctive cenobamate reduced focal (partial)-onset seizure frequency, in a dose-related fashion. Treatment-emergent adverse events were most frequent in the highest dose group. Cenobamate appears to be an effective treatment option in patients with uncontrolled focal seizures.
FUNDING


SK Life Science.",2020,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","['107 epilepsy and neurology centres in 16 countries', 'Between July 31, 2013, and June 22, 2015, 437 patients', 'patients with uncontrolled focal (partial)-onset epilepsy', 'Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs', 'patients with uncontrolled focal seizures']","['placebo', 'Cenobamate (YKP3089', 'adjunctive cenobamate', 'adjunctive cenobamate (YKP3089', 'cenobamate']","['seizure frequency', 'adverse events', 'safety, efficacy, and tolerability', 'eosinophilia and systemic symptoms', 'Safety and efficacy', 'modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates', 'percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures', 'Safety and tolerability', 'Responder rates']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}]",437.0,0.775707,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: gkrauss@jhmi.edu.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Adult Comprehensive Epilepsy Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Milanov', 'Affiliation': 'Neurology Clinic, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'Department for Epilepsies and Clinical Neurophysiology, Institute of Mental Health, Faculty for Special Education and Rehabilitation, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Department for Adults, Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'Medical Affairs, SK Life Science, Paramus, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30399-0']
191,31944276,"Efficacy and safety of adjunctive perampanel 4 mg/d for the treatment of focal seizures: A pooled post hoc analysis of four randomized, double-blind, phase III studies.","OBJECTIVE


This post hoc analysis evaluated the efficacy and safety of adjunctive perampanel 4 mg/d received as modal dose, which may have differed from randomized dose, for treatment of focal seizures.
METHODS


Data were pooled from four randomized, double-blind, placebo-controlled, phase III studies of adjunctive perampanel in patients (aged ≥12 years) with focal seizures, with/without focal to bilateral tonic-clonic (FBTC) seizures: studies 304 (NCT00699972), 305 (NCT00699582), 306 (NCT00700310), and 335 (NCT01618695). Efficacy assessments included median percentage reductions in seizure frequency per 28 days and seizure-freedom rates for patients receiving placebo and perampanel 4 mg/d (modal dose). Treatment-emergent adverse events (TEAEs) were assessed in patients receiving perampanel 4 mg/d at their TEAE onset. Outcomes were also assessed with/without enzyme-inducing antiseizure medications (EIASMs).
RESULTS


The full analysis set included 979 patients with focal seizures (placebo: n = 616 [235 with FBTC seizures]; perampanel 4 mg/d: n = 363 [134 with FBTC seizures]). Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424). Seizure improvements with perampanel 4 mg/d were greater without EIASMs than with EIASMs. For assessment of TEAEs, overall 1376 patients with focal seizures received perampanel 4 mg/d at any time (FBTC seizures, n = 499). TEAEs with perampanel 4 mg/d occurred in 419 of 1376 (30.5%) and 148 of 499 (29.7%) patients with focal and FBTC seizures, respectively; most common was dizziness. The proportion of TEAEs was similar with or without EIASMs.
SIGNIFICANCE


This post hoc analysis showed adjunctive perampanel 4 mg/d was efficacious and well tolerated in patients with focal seizures, with or without FBTC seizures. This dose may be a valuable treatment option in patients unable to tolerate higher perampanel doses up to 12 mg/d.",2020,"Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424).","['patients with focal seizures, with or without FBTC seizures', '979 patients with focal seizures (placebo: n\xa0=\xa0616 [235 with FBTC seizures', '1376 patients with focal seizures', 'focal seizures', 'in patients (aged\xa0≥12\xa0years) with focal seizures, with/without focal to bilateral tonic-clonic (FBTC) seizures', 'd: n\xa0=\xa0363']","['placebo', 'perampanel 4\xa0mg', 'perampanel', 'placebo, perampanel', 'adjunctive perampanel']","['efficacious and well tolerated', 'FBTC seizures', 'efficacy and safety', 'Efficacy and safety', 'seizure frequency per 28\xa0days and seizure-freedom rates', 'dizziness', 'antiseizure medications (EIASMs', 'seizure frequency', 'seizure-freedom rates for focal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3504770', 'cui_str': 'perampanel 4 MG [FYCOMPA]'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}]",979.0,0.632538,"Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424).","[{'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Formerly with Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",Epilepsia,['10.1111/epi.16428']
192,31740272,Mechanical circulatory support with the Impella® LP5.0 pump and an intra-aortic balloon pump for cardiogenic shock in acute myocardial infarction: The IMPELLA-STIC randomized study.,"BACKGROUND


Percutaneous assist devices may be used as a bridge to recovery in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI).
AIM


To test the hypothesis that the Impella® LP5.0 pump (Abiomed Europe GmbH, Aachen, Germany) provides haemodynamic benefits and improves left ventricular ejection fraction (LVEF) in patients with CS-AMI already managed with an intra-aortic balloon pump (IABP).
METHODS


This was a prospective randomized study. The primary endpoint was change in cardiac power index (CPI) from baseline to 12hours after implantation, measured with a Swan-Ganz catheter. Secondary endpoints included LVEF at 30 days.
RESULTS


Fifteen patients with CS-AMI were randomized; 12 were available for primary endpoint analysis (IABP group, n=6; Impella LP5.0+IABP group, n=6). Baseline characteristics were similar in both groups. Change in CPI after 12hours was not significantly different between the two groups (IABP group: ΔCPI=0.08±0.08W/m 2 ; Impella LP5.0+IABP group: ΔCPI=-0.02±0.25W/m 2 ; P=0.4). There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint. In the Impella LP5.0+IABP group, the part of the CPI provided by the native heart decreased from 0.37±0.10 to 0.10±0.20 (P=0.01). LVEF was similar at baseline (29.7%±8.4% and 29.3%±6.7%) and 1 month (40.6%±12.5% and 38.6%±14.4%) in the IABP and Impella LP5.0+IABP groups, respectively. Adverse events, especially major bleeding, were common, and occurred mainly in the Impella LP5.0+IABP group.
CONCLUSIONS


In patients with CS-AMI stabilized by initial treatment with inotropes and an IABP, the Impella LP5.0 did not provide additional haemodynamic support or improvement in LVEF at 1 month; its use in this setting might be futile and possibly harmful.",2020,"There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint.","['Fifteen patients with CS-AMI', 'patients with CS-AMI already managed with an intra-aortic balloon pump (IABP', 'patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI', 'acute myocardial infarction']",['Mechanical circulatory support with the Impella® LP5.0 pump and an intra-aortic balloon pump'],"['baseline CPI', 'LVEF at 30\xa0days', 'LVEF', 'change in cardiac power index (CPI', 'Change in CPI', 'native heart', 'Adverse events, especially major bleeding', 'CPI', 'left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump, device (physical object)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump, device (physical object)'}]","[{'cui': 'C0130753', 'cui_str': 'calpain inhibitor 2'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",,0.160674,"There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bochaton', 'Affiliation': 'Department of Intensive Cardiac Care, Hôpital Louis Pradel, Hospices Civils de Lyon, 59, boulevard Pinel, 69677 Bron, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Huot', 'Affiliation': 'Cellule Innovation, Hospices Civils de Lyon, 69677 Bron, France.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Department of Cardiology, Hôpital Rangueil, CHU de Toulouse, 31400 Toulouse, France.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Delmas', 'Affiliation': 'Department of Cardiology, Hôpital Rangueil, CHU de Toulouse, 31400 Toulouse, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Aissaoui', 'Affiliation': 'Department of Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, 75015 Paris, France.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Farhat', 'Affiliation': 'Department of Cardiac Surgery, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677 Bron, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677 Bron, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bonnefoy', 'Affiliation': 'Department of Intensive Cardiac Care, Hôpital Louis Pradel, Hospices Civils de Lyon, 59, boulevard Pinel, 69677 Bron, France. Electronic address: eric.bonnefoy-cudraz@univ-lyon1.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of cardiovascular diseases,['10.1016/j.acvd.2019.10.005']
193,32306296,Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.,"INTRODUCTION


The safety and efficacy of exenatide once weekly (EQW) is overall well established. EQW is primarily renally eliminated. In this study, the efficacy and renal and gastrointestinal tolerability of EQW were summarised in participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73 m 2 ) or CKD stage 2 (CKD2; mild renal impairment; eGFR ≥ 60 to < 90 mL/min/1.73 m 2 ).
METHODS


Data on participants with type 2 diabetes and baseline CKD3 or CKD2 from eight phase 3, double-blind or open-label studies with 26- or 28-week controlled treatment periods were pooled. Participants received EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin).
RESULTS


Participants with baseline CKD3 (N = 182) or CKD2 (N = 772) receiving EQW differed in a number of baseline characteristics, such as age < 65 years, race, mean body mass index and mean type 2 diabetes duration, whereas mean blood pressure and glycated haemoglobin (HbA 1c ) were similar. Mean reductions in HbA 1c , body weight and systolic blood pressure from baseline to week 26/28 in participants receiving EQW were similar between the CKD subgroups. The proportions of participants (CKD3 and CKD2) with any adverse event (AE) were 81% and 72%, respectively, for EQW and 74% and 68%, respectively, for all comparators; those for serious AEs were 2.7% and 3.4%, respectively, for EQW and 6% and 5%, respectively, for all comparators. Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar. There were no dehydration events; one participant in each treatment group had a serious AE of acute kidney injury (EQW with CKD3, n = 1; pioglitazone with CKD2, n = 1).
CONCLUSION


Exenatide once weekly was well tolerated and demonstrated similar efficacy in participants with type 2 diabetes with mild and moderate renal impairment.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT00637273, NCT00676338, NCT02229383, NCT02229396, NCT00641056, NCT01652729, NCT00935532, NCT01003184.",2020,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","['Participants with baseline', 'participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR]\u2009≥\u200930 to\u2009<\u200960\xa0mL', 'participants with type 2 diabetes and', 'participants with type 2 diabetes with mild and moderate renal impairment', 'Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease']","['EQW', 'exenatide', 'pioglitazone', 'Exenatide', 'CKD3', 'EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin']","['Safety and Efficacy', 'mean blood pressure and glycated haemoglobin (HbA 1c ', 'safety and efficacy', 'nausea and vomiting', 'Gastrointestinal AE rates', 'efficacy and renal and gastrointestinal tolerability', 'adverse event (AE', 'serious AE of acute kidney injury', 'Mean reductions in HbA 1c , body weight and systolic blood pressure']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.191815,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. cristian.guja@b.astral.ro.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marr', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00815-z']
194,32255473,"Øberg GK, Girolami GL, Campbell SK, et al. Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial. [Published online ahead of print January 16, 2020]. Phys Ther. 2020. DOI: 10.1093/ptj/pzaa014.",,2020,,['Neonatal Intensive Care Unit'],"['Parent-Administered Exercise Program', 'DOI']",[],"[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.085487,,"[{'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, PB 6050 Langnes, Tromsø, 9037 Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Suzann K', 'Initials': 'SK', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ivar', 'Initials': 'I', 'LastName': 'Heuch', 'Affiliation': 'Department of Mathematics, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjarne K', 'Initials': 'BK', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Centre for Sami Health Research, Department of Community Medicine, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Per Ivar', 'Initials': 'PI', 'LastName': 'Kaaresen', 'Affiliation': 'Pediatric and Adolescent Department, University Hospital North Norway; and Department of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Vibeke Smith', 'Initials': 'VS', 'LastName': 'Aulie', 'Affiliation': 'Section of Physiotherapy, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway.'}]",Physical therapy,['10.1093/ptj/pzaa026']
195,32020400,"Microwave ablation plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer: a multicenter, randomized, controlled, phase III clinical trial.","OBJECTIVES


This prospective trial was performed to verify whether microwave ablation (MWA) in combination with chemotherapy could provide superior survival benefit compared with chemotherapy alone.
MATERIALS AND METHODS


From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC) were randomly assigned to MWA plus chemotherapy group or chemotherapy group. The primary endpoint was progression-free survival (PFS), while the secondary endpoints included overall survival (OS), time to local progression (TTLP), and objective response rate (ORR). The complications and adverse events were also reported.
RESULTS


A total of 293 patients were randomly assigned into the two groups. One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group. One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group. The median follow-up period was 13.1 months and 12.4 months, respectively. Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001). Median OS was not reached in the MWA plus chemotherapy group and 12.6 months (95% CI 10.6-14.6) in the chemotherapy group (HR = 0.38, 95% CI 0.27-0.53; p < 0.0001) using Kaplan-Meier analyses with log-rank test. The median TTLP was 24.5 months, and the ORR was 32% in both groups. The adverse event rate was not significantly different in the two groups.
CONCLUSIONS


In patients with advanced NSCLC, longer PFS and OS can be achieved with the treatment of combined MWA and chemotherapy than chemotherapy alone.
KEY POINTS


• Patients treated with MWA plus chemotherapy had superior PFS and OS over those treated with chemotherapy alone. • The ORR of patients treated with MWA plus chemotherapy was similar to that of those treated with chemotherapy alone. • Complications associated with MWA were common but tolerable and manageable.",2020,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","['From March 1, 2015, to June 20, 2017, treatment-naïve patients with pathologically verified advanced or recurrent non-small cell lung cancer (NSCLC', 'One hundred forty-eight patients with 117 stage IV tumors were included in the MWA plus chemotherapy group', 'advanced non-small cell lung cancer', 'A total of 293 patients', 'One hundred forty-five patients with 113 stage IV tumors were included in the chemotherapy group']","['chemotherapy', 'MWA plus chemotherapy group or chemotherapy', 'microwave ablation (MWA', 'Microwave ablation plus chemotherapy versus chemotherapy', 'MWA plus chemotherapy']","['overall survival (OS), time to local progression (TTLP), and objective response rate (ORR', 'progression-free survival (PFS', 'median TTLP', 'Median PFS', 'complications and adverse events', 'superior PFS and OS', 'Median OS', 'adverse event rate', 'ORR']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",293.0,0.295302,"Median PFS was 10.3 months (95% CI 8.0-13.0) in the MWA plus chemotherapy group and 4.9 months (95% CI 4.2-5.7) in the chemotherapy group (HR = 0.44, 95% CI 0.28-0.53; p < 0.0001).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China. yexintaian2014@163.com.'}, {'ForeName': 'Qingliang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Licheng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Wenqiao', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The People's Liberation Army 88 Hospital, Tai'an, Shandong, China.""}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Dezhou People's Hospital, Dezhou, Shandong, China.""}, {'ForeName': 'Chuntang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Guangxu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, The Second People's Hospital of Dezhou, Dezhou, Shandong, China.""}, {'ForeName': 'Kaixian', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Peishun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Tengzhou Central People's Hospital, Zaozhuang, Shandong, China.""}, {'ForeName': 'Jingwang', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xue', 'Affiliation': 'Department of Oncology, Jinan Military General Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Oncology, Liaocheng Cancer Hospital, Liaocheng, Shandong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of Oncology, Weifang People's Hospital, Weifang, Shandong, China.""}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China.'}, {'ForeName': 'Shaoshui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Dianzhong', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, China.'}, {'ForeName': 'Benhua', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Liangming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Dengjun', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Xinglu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Cunqi', 'Initials': 'C', 'LastName': 'Diao', 'Affiliation': ""Department of Oncology, The People's Hospital of Pingyi Country, Linyi, Shandong, China.""}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Meng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ""Public Health School, Taishan Medical University, Tai'an, Shandong, China.""}, {'ForeName': 'Zhigeng', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, Shandong Province, China.'}]",European radiology,['10.1007/s00330-019-06613-x']
196,32312759,Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials.,"BACKGROUND


Vitamin E is an essential micronutrient and critical human antioxidant previously tested for cancer preventative effects with conflicting clinical trial results that have yet to be explained biologically.
METHODS


We examined baseline and on-trial serum samples for 154 men randomly assigned to receive 400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo daily in the Vitamin E Atherosclerosis Prevention Study (VEAPS), and for 100 men administered 50 IU ATA or placebo daily in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC). Over 970 metabolites were identified using ultrahigh-performance LC/MS-MS. Linear regression models estimated the change in serum metabolites of men supplemented with vitamin E versus those receiving placebo in VEAPS as compared with ATBC.
RESULTS


Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta/gamma-tocopherol were significantly altered by ATA supplementation in both trials (all  P  values ≤5.1 × 10 -5 , the Bonferroni multiple comparisons corrected statistical threshold). Serum C 22  lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β = -0.70,  P  = 8.1 × 10 -6 ), but not altered by the low dose in ATBC (β = -0.17,  P  = 0.4). In addition, changes in androgenic steroid metabolites were strongly correlated with the vitamin E supplement-associated change in C 22  lactone sulfate only in the VEAPS trial.
CONCLUSIONS


We found evidence of a dose-dependent vitamin E supplementation effect on a novel C 22  lactone sulfate compound that was correlated with several androgenic steroids.
IMPACT


Our data add information on a differential hormonal response based on vitamin E dose that could have direct relevance to opposing prostate cancer incidence results from previous large controlled trials.",2020,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","['100 men administered', '154 men randomly assigned to receive']","['placebo', '50 IU ATA or placebo', '400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo', 'Low- and High-Dose Vitamin E Supplementation', 'vitamin E']","['Serum Metabolomic Response', 'Serum C22 lactone sulfate', 'Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta-/gamma-tocopherol', 'androgenic steroid metabolites', 'C22 lactone sulfate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002602', 'cui_str': 'Aminotriazole'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1999896', 'cui_str': 'Alpha tocopherol acetate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0754985', 'cui_str': ""N,N'-ethylenebis(benzohydroxamamide)""}, {'cui': 'C0022947', 'cui_str': 'Lactone'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0969677', 'cui_str': 'alpha Tocopherol'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",970.0,0.292577,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Weinstein', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mondul', 'Affiliation': 'Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Demetrius', 'Initials': 'D', 'LastName': 'Albanes', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0187']
197,30828917,Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting.,"AIMS


Using a pragmatic approach, the LIRA-PRIME trial aims to address a knowledge gap by comparing efficacy in controlling glycaemia with glucagon-like peptide-1 analog liraglutide vs oral antidiabetic drugs (OADs) in patients with type 2 diabetes (T2D) uncontrolled with metformin monotherapy in primary care practice. We report the study design and patient baseline characteristics.
MATERIALS AND METHODS


This 104-week, two-arm, open-label, active-controlled trial is active in 219 primary care practices across nine countries. At screening, eligible patients with T2D were at least 18 years of age, had been using a stable daily dose of metformin ≥1500 mg or the maximum tolerated dose for ≥60 days, and had a glycated haemoglobin (HbA1c) of 7.5% to 9.0%, measured ≤90 days before screening. Patients were randomized (1:1) to liraglutide or OAD, both in addition to pre-trial metformin. Individual OADs were chosen by the treating physician based on local guidelines. The primary endpoint is time to inadequate glycaemic control, defined as HbA1c above 7.0% at two scheduled consecutive visits after the first 26 weeks of treatment.
RESULTS


The trial randomized 1997 patients with a mean (standard deviation) age of 56.9 (10.8) years, T2D duration of 7.2 (5.9) years (range, <1-47 years), and HbA1c of 8.2%. One-fifth of patients had a history of diabetes complications, and most were overweight (24.8%) or had obesity (65.3%).
CONCLUSIONS


This pragmatically designed, large-scale, multinational, randomized clinical trial will help guide treatment decisions for patients with T2D who are inadequately controlled with metformin monotherapy and treated in primary care.",2019,"The primary endpoint is time to inadequate glycaemic control, defined as HbA1c above 7.0% at two scheduled consecutive visits after the first 26 weeks of treatment.
","['eligible patients with T2D were at least 18 years of age', '1997 patients with a mean (standard deviation) age of 56.9 (10.8) years, T2D duration of 7.2 (5.9) years (range, <1-47\u2009years), and HbA1c of 8.2', '219 primary care practices across nine countries', 'LIRA-PRIME', 'patients with type 2 diabetes (T2D) uncontrolled with metformin monotherapy in primary care practice', 'patients with T2D who are inadequately controlled with metformin monotherapy and treated in primary care', 'type 2 diabetes in a primary care setting']","['liraglutide or OAD, both in addition to pre-trial metformin', 'glucagon-like peptide-1 analog liraglutide vs oral antidiabetic drugs (OADs', 'metformin', 'liraglutide']","['time to inadequate glycaemic control', 'history of diabetes complications', 'glycated haemoglobin (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0342257', 'cui_str': 'Diabetes Complications'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",1997.0,0.118445,"The primary endpoint is time to inadequate glycaemic control, defined as HbA1c above 7.0% at two scheduled consecutive visits after the first 26 weeks of treatment.
","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Unger', 'Affiliation': 'Unger Concierge Primary Care Medical Group, Ranch Cucamonga, California.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Allison', 'Affiliation': 'Hillcrest Family Health Center, Waco, Texas.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Carlton', 'Affiliation': 'Physician Practice Research, Sentara Medical Group, Norfolk, Virginia.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Lakkole', 'Affiliation': 'M. S. Ramaiah Medical College and Hospital, Bengaluru, India.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Ocean West Research, Surrey, British Columbia, Canada.'}, {'ForeName': 'Gerri', 'Initials': 'G', 'LastName': 'Murphy', 'Affiliation': 'Commonwealth Medical Clinic, Mount Pearl, Newfoundland, Canada.'}, {'ForeName': 'Jayant K', 'Initials': 'JK', 'LastName': 'Panda', 'Affiliation': 'Department of Medicine, SCB Medical College, Cuttack, India.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sargin', 'Affiliation': 'Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Kaltoft', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne B', 'Initials': 'MB', 'LastName': 'Treppendahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marouan', 'Initials': 'M', 'LastName': 'Zoghbi', 'Affiliation': 'Middle East Institute of Health University Hospital, Bsalim, Lebanon.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13682']
198,30414453,Outcomes after Pancreatectomy with Routine Pasireotide Use.,"BACKGROUND


Morbidity after pancreatectomy is commonly due to leakage of exocrine secretions resulting in abscess or pancreatic fistula (PF). Previously, we authored a double-blind randomized controlled trial demonstrating that perioperative pasireotide administration lowers abscess or PF formation by >50%. Accordingly, we adopted pasireotide use as standard practice after pancreatectomy in October 2014 and hypothesized a similar PF/abscess rate reduction would be observed.
STUDY DESIGN


A prospectively maintained database was queried for all patients who underwent pancreatectomy between October 2014 and July 2017. Pasireotide was administered preoperatively and twice daily for 7 days postoperatively or until discharge. The primary end point was clinically relevant PF/abscess requiring procedural intervention, identical to the earlier trial outcomes. Logistic regression was used to compare outcomes with the placebo arm of the earlier randomized trial and to control known PF risk factors.
RESULTS


During the 34-month study period, 652 patients underwent pancreatectomy (211 distal pancreatectomy, 441 pancreaticoduodenectomy). Compared with the historical placebo group (n = 148), the observational group had an increased prevalence of higher American Society of Anesthesiologists scores (69% vs 54%; p < 0.001) and high-risk cases (small duct and soft gland, 47% vs 36%; p = 0.030). The primary end point occurred in 13.3% of patients receiving pasireotide vs 20.9% in the placebo arm of the earlier trial trial (odds ratio 0.58; 95% CI 0.37 to 0.92; p = 0.020). Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged. No subpopulation was identified more likely to benefit from pasireotide.
CONCLUSIONS


At our center, adoption of pasireotide has allowed us to achieve a clinically significant abscess or pancreatic leak rate of 13.3%, approximating the effect observed in the randomized trial of pasireotide during routine surgical practice.",2019,"Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged.","['A prospectively maintained database was queried for all patients who underwent pancreatectomy between October 2014 and July 2017', '652 patients underwent pancreatectomy (211 distal pancreatectomy, 441 pancreaticoduodenectomy']","['historical placebo', 'perioperative pasireotide', 'placebo', 'Pasireotide']","['prevalence of higher American Society of Anesthesiologists scores', 'abscess or PF formation', 'Biliary leakage', 'clinically relevant PF/abscess requiring procedural intervention', 'morbidity']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",652.0,0.323377,"Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kunstman', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Goldman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gönen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Vinod P', 'Initials': 'VP', 'LastName': 'Balachandran', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': ""D'Angelica"", 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'T Peter', 'Initials': 'TP', 'LastName': 'Kingham', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Jarnagin', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Allen', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: allenp@mskcc.org.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2018.10.018']
199,31299343,Effect of concentrated growth factor (CGF) on short-term clinical outcomes after partially impacted mandibular third molar surgery: A split-mouth randomized clinical study.,"PURPOSE


The aim of this study was to evaluate the effectiveness of concentrated growth factor(CGF) on soft tissue healing and postoperative side effects following third molar surgery.
METHODS


This study was designed on 60 patients as a randomized single-blind clinical trial. The predictor variable was the implementation of CGF fibrin matrix, which was categorized as CGF and non-CGF. The primary outcome variable of the study was the healing of soft tissue around the extraction socket. The secondary outcome variables were pain, swelling and trismus. Data were analyzed using the non-parametric Brunner and Langer model. Statistical significance was set at P<.001.
RESULTS


Sixty patients (39 female, 21 male; mean age 25.82) with impacted mandibular third molars participated in the study. Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
CONCLUSION


The application of CGF accelerates soft tissue healing and is beneficial in minimising postoperative side effects, particularly pain, swelling and trismus, after extraction of mandibular third molars.
CLINICAL TRIALS NUMBER


NCT03913884.",2020,"Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
","['Sixty patients (39 female, 21 male; mean age 25.82) with impacted mandibular third molars participated in the study', '60 patients', 'partially impacted mandibular third molar surgery']","['CGF', 'concentrated growth factor(CGF', 'concentrated growth factor (CGF']","['healing of soft tissue around the extraction socket', 'pain, swelling and trismus', 'soft tissue healing and postoperative side effects', 'soft tissue healing, postoperative pain, swelling, and trismus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",60.0,0.163549,"Statistical analysis revealed that there were significant differences between the control and test groups with regard to soft tissue healing, postoperative pain, swelling, and trismus (P<0.001).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Özveri Koyuncu', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: banuozverikoyuncu@yahoo.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Işık', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: gozdech@hotmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özden Yüce', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: meltemozdn@hotmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Günbay', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: sevtapgunbay@gmail.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Günbay', 'Affiliation': 'Ege University, School of Dentistry, Department of Oral Surgery, Erzene AVE, 35040 Bornova, İzmir, Turkey. Electronic address: tgunbay@gmail.com.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.002']
200,31771797,"Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received.","BACKGROUND


The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy.
OBJECTIVE


To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts.
DESIGN, SETTING, AND PARTICIPANTS


This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy.
INTERVENTION


Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores.
RESULTS AND LIMITATIONS


According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa.
CONCLUSIONS


Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group.
PATIENT SUMMARY


More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.",2020,"According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003).","['men with localised prostate cancer', '100 men with low or intermediate risk localised prostate cancer', 'Men with Localised Prostate Cancer', 'Two cohorts included 1643 men who agreed to be randomised and 997 who declined randomisation and chose treatment', 'Men with clinically localised prostate cancer at one of nine UK centres']","['active monitoring (AM), radical prostatectomy, and external beam radiotherapy', 'AM, radical prostatectomy, and radiotherapy']","['disease progression', 'urinary incontinence', 'PCa mortality', 'sexual dysfunction', 'mortality, metastasis and progression and health-related quality of life impacts on urinary, bowel, and sexual function', 'bowel dysfunction', 'rates of disease-related events', 'higher risks of sexual dysfunction', 'sexual and bladder function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C2004461', 'cui_str': 'Bowel dysfunction (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0232840', 'cui_str': 'Bladder function (observable entity)'}]",1643.0,0.143431,"According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003).","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.10.030']
201,32266044,A Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention on Cardiovascular Reactivity to Social-Evaluative Threat Among Adults with Obesity.,"Objective


Mindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the ""challenge and threat"" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors.
Methods


Adults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity.
Results


Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index.
Conclusions


Mindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.",2019,"Results


Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP.","['persons with obesity', 'Adults with Obesity', 'Methods\n\n\nAdults (N=194) with obesity']","['5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines', 'mindfulness training', 'Mindfulness-Based Weight Loss Intervention']","['Electrocardiogram, impedance cardiography, and blood pressure', 'speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity', 'challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR', 'maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C1098484', 'cui_str': 'TPR protein, human'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",194.0,0.0190553,"Results


Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'Institute of Holistic Health Studies, San Francisco State University.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'BayView Hunters Point Clinic.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kristeller', 'Affiliation': 'Department of Psychology, Indiana State University.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Mendes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}]",Mindfulness,['10.1007/s12671-019-01232-5']
202,30850995,Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7).,"AIMS


The aim of this study was to describe the risks of cardiovascular (CV) events and severe hypoglycaemia with insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) aged 65 years or older.
MATERIALS AND METHODS


A total of 7637 patients in the DEVOTE trial, a treat-to-target, randomized, double-blind trial evaluating the CV safety of degludec vs glargine U100, were divided into three age groups (50-64 years, n = 3682; 65-74 years, n = 3136; ≥75 years, n = 819). Outcomes by overall age group and randomized treatment differences were analysed for major adverse cardiovascular events (MACE), all-cause mortality, severe hypoglycaemia and serious adverse events (SAEs).
RESULTS


Patients with increasing age had higher risks of CV death, all-cause mortality and SAEs, and there were non-significant trends towards higher risks of MACE and severe hypoglycaemia. Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes.
CONCLUSIONS


There were higher risks of CV death, all-cause mortality and SAEs, and trends towards higher risks of MACE and severe hypoglycaemia with increasing age after adjusting for baseline differences. The effects across age groups of degludec vs glargine U100 on MACE, all-cause mortality and severe hypoglycaemia were comparable, suggesting that the risk of MACE, as well as all-cause mortality, is similar and the risk of severe hypoglycaemia is lower with degludec regardless of age. Evidence is conclusive only until 74 years of age.",2019,"Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes.
","['patients with type 2 diabetes (T2D) aged 65\u2009years or older', 'patients with type 2 diabetes aged 65 years or older', '7637 patients in the DEVOTE trial, a treat-to-target, randomized, double-blind trial evaluating the CV safety of degludec vs glargine U100, were divided into three age groups (50-64\u2009years, n =\u20093682; 65-74\u2009years, n =\u20093136; ≥75\u2009years, n =\u2009819']","['insulin degludec (degludec) vs insulin glargine 100\u2009units/mL (glargine U100', 'insulin degludec versus insulin glargine U100']","['risks of MACE and severe hypoglycaemia', 'Cardiovascular safety', 'mortality and severe hypoglycaemia', 'risks of CV death', 'risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs', 'higher risks of CV death', 'risks of cardiovascular (CV) events and severe hypoglycaemia', 'major adverse cardiovascular events (MACE), all-cause mortality, severe hypoglycaemia and serious adverse events (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",7637.0,0.117242,"Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes.
","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, Florida.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Emerson', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gilbert', 'Affiliation': 'Larner College of Medicine at The University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Health Heart and Vascular Institute, Kansas City, Missouri.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Charlotte T', 'Initials': 'CT', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Moses', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13699']
203,32304832,"Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial.","BACKGROUND


Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.
OBJECTIVE


This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.
METHODS


Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1  ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.
RESULTS


Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.
CONCLUSIONS


Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.",2020,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"['Children with Allergic Rhinoconjunctivitis', 'children with AR/C.\nMETHODS\n\n\nChildren (N=1025; 77.7% polysensitized) aged 5-17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1  ≥80% predicted', 'adults with allergic rhinitis with or without conjunctivitis (AR/C']","['Ragweed SLIT-Tablet', 'ragweed SLIT-tablet', 'placebo', 'SLIT-tablet versus placebo', 'Ragweed SLIT-tablet', 'Placebo', 'daily ragweed SLIT-tablet (12 Amb a 1-Unit ) or placebo']","['Efficacy and Safety', 'average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS', 'DSS and DMS during peak RPS', 'anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions', 'tolerated', 'TCS during the entire RPS, and DSS and DMS during peak RPS', 'Asthma DSS, short-acting beta-agonist use, and nocturnal awakenings during peak RPS', 'efficacy and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0331432', 'cui_str': 'Ambrosia'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0012384', 'cui_str': 'Succimer'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C4055482', 'cui_str': 'Airway compromise'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1736167', 'cui_str': 'Systemic allergic reaction'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]",,0.42318,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Nolte', 'Affiliation': 'ALK, Bedminster, NJ. Electronic address: Hendrik.nolte@alk.net.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Allergy/Immunology Service, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kleine-Tebbe', 'Affiliation': 'Allergy & Asthma Center Westend, Berlin, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.041']
204,31326593,Ropivacaine versus placebo on postoperative analgesia and chronic pain following third molar extraction: A Prospective Randomized Controlled Study.,"PURPOSE


The present study aimed at assessing the efficiency of ropivacaine on post-operative pain for extraction of third molars.
METHODS


In a single centre, prospective, parallel, double blind randomised trial, patients scheduled for removal of all four third molars, ASA I-III patients<65 year-old patients were included. After intubation under general anesthesia (using intravenous remifentanil and propofol), for each of the third molars, 2mL of ropivacaine (7.5mg/mL) or placebo (0.9% saline solution) was injected into the vestibular capsule (total: 8mL) before extraction. At the end of surgery, similar analgesia was injected for both groups (intravenous paracetamol 1g and ketoprofene 100mg). The primary outcome was postoperative pain assessed by Visual Analog Scale (VAS). Postoperative consumption of analgesics (morphine titration in post-operative care unit when VAS>3/10, followed by oral tramadol 50mg after discharge), patient satisfaction, chronic pain (1-3 month), time in PACU and total hospitalization time were also recorded.
RESULTS


A total of 50 patients were analysed in each group with similar characteristics (ropivacaine vs. control, for age (years) 18 [17-21] vs. 18 [17-21], for sex (female) 33 (66%) vs. 25 (50%), and BMI (kg/m 2 ): 20 [19-23] vs. 21 [19-23]). Area Under the Curve for VAS pain (0 to 4h) was lower for Ropivacaine group: 0.43 [0.19-0.66] vs. 0.63 [0.43-0.87], P=0.005. Use of morphine in PACU (8 vs. 18, P=0.02) and median length of stay in ambulatory setting (5 vs. 6h, P=0.03) were reduced in Ropivacaine vs. Placebo group. At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05). At month 1 and 3, pain and DN4 score were similar between groups, with a median VAS pain score at 0 for both groups (P=0.42). No difference was observed for patient satisfaction and adverse events.
CONCLUSIONS


Ropivacaine provides an immediate efficient pain relief after extraction of third molars without benefit after discharge.
CLINICALTRIAL REGISTRATION


NCT01541059.",2020,"At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05).","['patients scheduled for removal of all four third molars, ASA I-III', 'patients<65 year-old patients were included', 'A total of 50 patients were analysed in each group with similar characteristics (ropivacaine vs. control, for age (years) 18 [17-21] vs. 18 [17-21], for sex (female) 33 (66%) vs. 25 (50%), and BMI (kg/m 2 ): 20 [19-23] vs. 21 [19-23', 'following third molar extraction']","['Ropivacaine', 'remifentanil and propofol', 'Ropivacaine vs. Placebo', 'placebo', 'ropivacaine', 'morphine', 'analgesics (morphine titration']","['median VAS pain score', 'postoperative pain assessed by Visual Analog Scale (VAS', 'patient satisfaction and adverse events', 'time in PACU and total hospitalization time', 'patient satisfaction, chronic pain', 'postoperative analgesia and chronic pain', 'VAS of pain', 'pain and DN4 score', 'VAS pain', 'median length of stay in ambulatory setting']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]",,0.691117,"At days 1 and 4, VAS of pain was higher in Ropivacaine group (respectively 4 vs. 2, P=0.006 and 3 vs. 2, P=0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ghezal', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bouvet', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Univ. Montpellier, CHU de Nîmes, Nîmes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kabani', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Univ. Montpellier, CHU de Nîmes, Nîmes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ripart', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': 'Department of Anaesthesia, Pain and Intensive Care Medicine, Univ. Montpellier 1, CHU de Nîmes, place du Professeur Debré, 30029 Nîmes cedex 09, France. Electronic address: philippe.cuvillon@chu-nimes.fr.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.005']
205,30768393,"Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder.","OBJECTIVE


Trigeminal nerve stimulation (TNS), a minimal-risk noninvasive neuromodulation method, showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. The present blinded sham-controlled trial was conducted to assess the efficacy and safety of TNS for ADHD and potential changes in brain spectral power using resting-state quantitative electroencephalography.
METHOD


Sixty-two children 8 to 12 years old, with full-scale IQ of at least 85 and Schedule for Affective Disorders and Schizophrenia-diagnosed ADHD, were randomized to 4 weeks of nightly treatment with active or sham TNS, followed by 1 week without intervention. Assessments included weekly clinician-administered ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales and quantitative electroencephalography at baseline and week 4.
RESULTS


ADHD-RS total scores showed significant group-by-time interactions (F 1,228  = 8.12, p = .005; week 4 Cohen d = 0.5). CGI-Improvement scores also favored active treatment (χ 2 1,168  = 8.75, p = .003; number needed to treat = 3). Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS. Neither group had clinically meaningful adverse events.
CONCLUSION


This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants. TNS is well tolerated and has minimal risk. Additional research should examine treatment response durability and potential impact on brain development with sustained use.
CLINICAL TRIAL REGISTRATION INFORMATION


Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov/; NCT02155608.",2019,Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS.,"['Sixty-two children 8 to 12 years old, with full-scale IQ of at least 85 and Schedule for Affective Disorders and Schizophrenia-diagnosed ADHD']","['Trigeminal Nerve Stimulation', 'Trigeminal nerve stimulation (TNS', 'nightly treatment with active or sham TNS', 'TNS']","['clinically meaningful adverse events', 'weekly clinician-administered ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales and quantitative electroencephalography at baseline and week\xa04', 'ADHD-RS total scores', 'CGI-Improvement scores', 'efficacy and safety']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0040996', 'cui_str': 'Cranial Nerve V'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0045733', 'cui_str': 'mansic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.212805,Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS.,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McGough', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA. Electronic address: jmcgough@mednet.ucla.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sturm', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cowen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Tung', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}, {'ForeName': 'Giulia C', 'Initials': 'GC', 'LastName': 'Salgari', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Leuchter', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Cook', 'Affiliation': 'David Geffen School of Medicine at UCLA, the Henry Samueli School of Engineering and Applied Science at UCLA, and NeuroSigma, Inc., Los Angeles, CA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'David Geffen School of Medicine and the Fielding School of Public Health at UCLA, Los Angeles, CA.'}, {'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Loo', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, CA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.11.013']
206,30768404,"Shortened Sleep Duration Causes Sleepiness, Inattention, and Oppositionality in Adolescents With Attention-Deficit/Hyperactivity Disorder: Findings From a Crossover Sleep Restriction/Extension Study.","OBJECTIVE


Although poor sleep is often reported in adolescents with attention-deficit/hyperactivity disorder (ADHD), prior studies have been correlational. This study investigated whether sleep duration is causally linked to sleepiness, inattention, and behavioral functioning in adolescents with ADHD.
METHOD


A total of 72 adolescents (aged 14-17 years) entered a 3-week sleep protocol using an experimental crossover design. The protocol included a phase stabilization week, followed in randomized counterbalanced order by 1 week of sleep restriction (6.5 hours) and 1 week of sleep extension (9.5 hours). Sleep was monitored with actigraphy and daily sleep diaries, with laboratory visits at the end of each week. Analyses included 48 adolescents who had complete actigraphy data and successfully completed the sleep protocol (defined a priori as obtaining ≥1 hour actigraphy-measured sleep duration during extension compared to restriction). Parent and adolescent ratings of daytime sleepiness, ADHD symptoms, sluggish cognitive tempo (SCT), and oppositional behaviors were the primary measures. The A-X Continuous Performance Test (CPT) was a secondary measure.
RESULTS


Compared to the extended sleep week, parents reported more inattentive and oppositional symptoms during the restricted sleep week. Both parents and adolescents reported more SCT symptoms and greater daytime sleepiness during restriction compared to extension. Adolescents reported less hyperactivity-impulsivity during sleep restriction than extension. No effects were found for parent-reported hyperactivity-impulsivity, adolescent-reported ADHD inattention, or CPT performance.
CONCLUSION


This study provides the first evidence that sleep duration is a causal contributor to daytime behaviors in adolescents with ADHD. Sleep may be an important target for intervention in adolescents with ADHD.
CLINICAL TRIAL REGISTRATION INFORMATION


Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD; https://clinicaltrials.gov/; NCT02732756.",2019,"Compared to the extended sleep week, parents reported more inattentive and oppositional symptoms during the restricted sleep week.","['48 adolescents who had complete actigraphy data and successfully completed the sleep protocol (defined a priori as obtaining\xa0≥1 hour actigraphy-measured sleep duration during extension compared to restriction', 'Adolescents With ADHD', 'adolescents with ADHD', 'adolescents with attention-deficit/hyperactivity disorder (ADHD', '72 adolescents (aged 14-17 years', 'Adolescents With Attention-Deficit/Hyperactivity Disorder']",['sleep protocol'],"['SCT symptoms and greater daytime sleepiness', 'Sleep', 'hyperactivity-impulsivity', 'inattentive and oppositional symptoms', 'Parent and adolescent ratings of daytime sleepiness, ADHD symptoms, sluggish cognitive tempo (SCT), and oppositional behaviors', 'hyperactivity-impulsivity, adolescent-reported ADHD inattention, or CPT performance', 'Shortened Sleep Duration Causes Sleepiness, Inattention, and Oppositionality']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",72.0,0.0581357,"Compared to the extended sleep week, parents reported more inattentive and oppositional symptoms during the restricted sleep week.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Becker', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH, and the University of Cincinnati College of Medicine, Cincinnati, OH. Electronic address: stephen.becker@cchmc.org.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH, and the University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH, and the University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Alina A', 'Initials': 'AA', 'LastName': 'Tilford', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH.""}, {'ForeName': 'Clair M', 'Initials': 'CM', 'LastName': 'Tischner', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Isaacson', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH.""}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Simon', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH, and the University of Cincinnati College of Medicine, Cincinnati, OH.""}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.09.439']
207,30830727,Efficacy and safety of pemafibrate in people with type 2 diabetes and elevated triglyceride levels: 52-week data from the PROVIDE study.,"The aim of this study was to evaluate the efficacy and safety of pemafibrate in people with type 2 diabetes and hypertriglyceridaemia over a 52-week period. Participants were randomly assigned to receive treatment with placebo or pemafibrate at a dose of 0.2 or 0.4 mg/d for 24 weeks (treatment period 1). The main results from treatment period 1 have been reported previously. The assigned treatment was continued up to week 52, except that the placebo was changed to pemafibrate 0.2 mg/d after week 24 (treatment period 2). The percentage changes in fasting serum triglyceride (TG) levels at week 52 (last observation carried forward) were -48.2%, -42.3%, and -46.4% in the placebo/pemafibrate 0.2 mg/d (n = 57), pemafibrate 0.2 mg/d (n = 54), and pemafibrate 0.4 mg/d (n = 55) groups, respectively. Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks. Pemafibrate was well tolerated throughout the study period. The present study is the first to show that pemafibrate treatment substantially ameliorated lipid abnormalities and was well tolerated for 52 weeks in people with type 2 diabetes and hypertriglyceridaemia.",2019,"Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks.","['people with type 2 diabetes and elevated triglyceride levels', 'people with type 2 diabetes and hypertriglyceridaemia', 'people with type 2 diabetes and hypertriglyceridaemia over a 52-week period']","['placebo', 'pemafibrate', 'placebo or pemafibrate']","['Levels of TG, non-HDL cholesterol and total cholesterol stably', 'HDL cholesterol', 'lipid abnormalities', 'fasting serum triglyceride (TG) levels', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4547051', 'cui_str': 'pemafibrate'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.06673,"Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shizuya', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'National Centre for Geriatrics and Gerontology, Aichi, Japan.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Satoh', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Miyagi, Japan.'}, {'ForeName': 'Toyoshi', 'Initials': 'T', 'LastName': 'Inoguchi', 'Affiliation': 'Fukuoka Health Promotion Support Centre, Fukuoka, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Maegawa', 'Affiliation': 'Department of Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Narihito', 'Initials': 'N', 'LastName': 'Yoshioka', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Hokkaido, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Tanizawa', 'Affiliation': 'Division of Endocrinology, Metabolism, Haematological Science and Therapeutics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Department, Kowa Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Ishibashi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13686']
208,32301501,Response to Inhibition of Receptor-Interacting Protein Kinase 1 (RIPK1) in Active Plaque Psoriasis: A Randomized Placebo-Controlled Study.,"Receptor-interacting protein kinase 1 (RIPK1), a regulator of inflammation and cell death, is a potential therapeutic target in immune-mediated inflammatory diseases (IMIDs). The objective of this phase IIa multicenter, randomized, double-blind, placebo-controlled study was to evaluate safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy of GSK2982772, a RIPK1 inhibitor, in plaque-type psoriasis. Psoriasis patients (N = 65) were randomized to 60 mg twice daily (b.i.d.) or three times daily (t.i.d.), or placebo for 84 days. Most adverse events (AEs) were mild with no severe drug-related AEs reported. Plaque Lesion Severity Sum improved with b.i.d. treatment compared with placebo; interpretation of t.i.d. treatment results was complicated by a high placebo response. Reductions in epidermal thickness and infiltration by CD3+ T cells in the epidermis and dermis were observed compared with placebo. Results support the rationale for additional studies on RIPK1 inhibition in IMIDs.",2020,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"['plaque-type psoriasis', 'Psoriasis patients (N=65', 'active plaque psoriasis']","['receptor-interacting protein kinase 1 (RIPK1', 'placebo']","['safety, tolerability pharmacokinetics, pharmacodynamics', 'epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis', 'Plaque Lesion Severity Sum', 'adverse events (AEs']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0241148', 'cui_str': 'Cutaneous plaque'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.614395,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'InnovaDerm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Scott', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Tompson', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bertin', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Peter Tak', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1852']
209,32299254,Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study.,"Objective:  This study aimed to compare efficacy and safety of lidocaine versus tramadol versus placebo in reducing the pain of diagnostic outpatient hysteroscopy (OH) in postmenopausal women. Materials and methods:  This randomized double-blinded study included 156 menopausal women who received intrauterine lidocaine infusion or oral tramadol (50 mg) or placebo before diagnostic OH (52 women/group). Primary outcome was pain severity during the procedure using a 10-cm visual analog scale. Secondary outcomes were pain scores 10 and 30 min post procedure, satisfaction level, and ease of cervical entry. Results:  Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001). Tramadol had lower pain scores than placebo during the procedure ( p  = 0.04), 10 min after the procedure ( p  = 0.03), and 30 min after the procedure ( p  = 0.04). Both lidocaine and tramadol resulted in an easier procedure than placebo ( p  < 0.001 and  p  = 0.04, respectively). Lidocaine had an easier cervical entry compared to tramadol ( p  = 0.004). Satisfaction scores in the lidocaine and tramadol groups were significantly higher than in the placebo group ( p  < 0.001). Conclusions:  Lidocaine and tramadol were effective in reducing postmenopausal women-reported pain during and after diagnostic OH. However, lidocaine was better than tramadol in facilitating hysteroscope passage through the cervical canal and the reduction in pain levels with lidocaine was clinically relevant. Trial registration number:  NCT03701984.",2020,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"['before diagnostic OH (52 women/group', '156 menopausal women who received', 'postmenopausal women']","['Lidocaine', 'lidocaine', 'placebo', 'tramadol', 'intrauterine lidocaine infusion or oral tramadol (50\u2009mg) or placebo', 'diagnostic office hysteroscopy', 'Lidocaine and tramadol', 'Tramadol']","['pain levels', 'postmenopausal women-reported pain', 'lower pain scores', 'pain of diagnostic outpatient hysteroscopy (OH', 'Satisfaction scores', 'easier cervical entry', 'pain scores 10 and 30\u2009min post procedure, satisfaction level, and ease of cervical entry', 'efficacy and safety', 'pain severity during the procedure using a 10-cm visual analog scale', 'Pain management']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",156.0,0.686822,Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( p  < 0.001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Kasr Alainy, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Mahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Abdel-Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1742685']
210,32287316,Ototopical drops containing a novel antibacterial synthetic peptide: Safety and efficacy in adults with chronic suppurative otitis media.,"OBJECTIVE


Chronic suppurative otitis media (CSOM) is a chronic infectious disease with worldwide prevalence that causes hearing loss and decreased quality of life. As current (antibiotic) treatments often unsuccessful and antibiotic resistance is emerging, alternative agents and/or strategies are urgently needed. We considered the synthetic antimicrobial and anti-biofilm peptide P60.4Ac to be an interesting candidate because it also displays anti-inflammatory activities including lipopolysaccharide-neutralizing activity. The aim of the present study was to investigate the safety and efficacy of ototopical drops containing P60.4Ac in adults with CSOM without cholesteatoma.
METHODS


We conducted a range-finding study in 16 subjects followed by a randomized, double blinded, placebo-controlled, multicentre phase IIa study in 34 subjects. P60.4Ac-containing ototopical drops or placebo drops were applied twice a day for 2 weeks and adverse events (AEs) and medication use were recorded. Laboratory tests, swabs from the middle ear and throat for bacterial cultures, and audiometry were performed at intervals up to 10 weeks after therapy. Response to treatment was assessed by blinded symptom scoring on otoscopy.
RESULTS


Application of P60.4Ac-containing ototopical drops (0.25-2.0 mg of peptide/ml) in the ear canal of patients suffering from CSOM was found to be safe and well-tolerated. The optimal dose (0.5 mg of peptide/ml) was selected for the subsequent phase IIa study. Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity. In addition to this excellent safety profile, P60.4Ac ototopical drops resulted in a treatment success in 47% of cases versus 6% in the placebo group.
CONCLUSION


The efficacy/safety balance assessed in the present study provides a compelling justification for continued clinical development of P60.4Ac in therapy-resistant CSOM.",2020,"Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity.","['Chronic suppurative otitis media (CSOM', '16 subjects', 'controlled, multicentre phase IIa study in 34 subjects', 'adults with CSOM without cholesteatoma', 'adults with chronic suppurative otitis media']","['ototopical drops containing P60.4Ac', 'P60.4Ac-containing ototopical drops or placebo', 'placebo', 'Ototopical drops containing a novel antibacterial synthetic peptide']","['safety and efficacy', 'safe and well-tolerated', 'efficacy/safety balance']","[{'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",16.0,0.265936,"Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity.","[{'ForeName': 'Nanno F A W', 'Initials': 'NFAW', 'LastName': 'Peek', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Marja J', 'Initials': 'MJ', 'LastName': 'Nell', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Brand', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'Jansen-Werkhoven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Ewoud J', 'Initials': 'EJ', 'LastName': 'van Hoogdalem', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Verrijk', 'Affiliation': ""Octoplus Technologies BV/Dr Reddy's research and development BV, Leiden, The Netherlands.""}, {'ForeName': 'Marcel J', 'Initials': 'MJ', 'LastName': 'Vonk', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Amon R', 'Initials': 'AR', 'LastName': 'Wafelman', 'Affiliation': 'Clinical Pharmacology and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'A Rob P M', 'Initials': 'ARPM', 'LastName': 'Valentijn', 'Affiliation': 'Clinical Pharmacology and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Johan H M', 'Initials': 'JHM', 'LastName': 'Frijns', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Hiemstra', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Drijfhout', 'Affiliation': 'Immunohematology and Blood Transfusion, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Nibbering', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Grote', 'Affiliation': 'Department of Ear Nose and Throat, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0231573']
211,32299845,"Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.","OBJECTIVES


Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression.
METHODS


In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52.
RESULTS


At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths.
CONCLUSIONS


Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.",2020,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[""adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received"", 'n=57) with riociguat and -0.77±8.24', 'patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression', 'patients with early diffuse cutaneous systemic sclerosis (RISE-SSc']","['riociguat', 'riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo', 'placebo']","['forced vital capacity', ""average Raynaud's condition score"", 'tolerated', 'efficacy and safety', 'change in mRSS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C3667592', 'cui_str': 'riociguat 0.5 MG'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0034734', 'cui_str': ""Raynaud's disease""}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}]",,0.511816,"At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo.","[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu oliver.distler@usz.ch.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology A department, Cochin Hospital, APHP, Paris Descartes University, Paris, France.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Division of Medicine, Centre for Rheumatology, University College London, London, UK.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Schulich School of Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Bečvář', 'Affiliation': 'Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Czirják', 'Affiliation': 'Department of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Claude Huriez Hospital, Lille University School of Medicine, Lille, France.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Dermatology, Gunma University Postgraduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University Health Network, Mount Sinai Hospital, University of Toronto, Toronto Scleroderma Research Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'De Langhe', 'Affiliation': 'Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stagnaro', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Riccieri', 'Affiliation': 'Department of Clinical Medicine and Therapy, University of Rome La Sapienza, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Schiopu', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Michigan Medicine University Hospitals, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': ""Department of Rheumatology, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Szücs', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marie-Elise', 'Initials': 'ME', 'LastName': 'Truchetet', 'Affiliation': 'Department of Rheumatology, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wosnitza', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Laapas', 'Affiliation': 'StatFinn Oy, Espoo, Finland.'}, {'ForeName': 'Janethe', 'Initials': 'J', 'LastName': 'de Oliveira Pena', 'Affiliation': 'Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Bayer Healthcare, Beijing, China.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kramer', 'Affiliation': 'Research & Development, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital, Zurich, Switzerland khannad@med.umich.edu oliver.distler@usz.ch.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216823']
212,32303737,"Within-Patient, Single-Blinded, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Triamcinolone Acetonide Injections for the Treatment of Hypertrophic Scar in Adult Burn Survivors.","Intralesional corticosteroid (triamcinolone acetonide [TAC]) injections have become one of the cornerstone treatments of hypertrophic scar (HSc). However, the evidence is of limited-quality, and published investigations have almost exclusively been performed in linear scars rather than hypertrophic burn scars. Thus, the aim of this study was to perform an appropriately powered, single-blinded, randomized controlled trial to evaluate the impact of TAC injections on burn HSc compared with patient-matched usual care control scars. Fifty burn survivors with two scars (separated by nonscarred skin preferably on the contralateral side or an anatomically similar site) were selected based on high-frequency ultrasound thickness (>2.034 mm to ensure that the site was outside of the range of normal scar). Pretreatment thickness measurements of the two sites were within 0.5 mm of each other, to ensure homogeneity and an erythema index >300 to establish they were immature HSc. The sites were randomly assigned to treatment or control. The treatment HSc received a 10 mg/ml TAC. When necessary, the injection was repeated after 6 weeks and a third final injection 6 weeks later. Objective evaluation of thickness, elasticity, erythema, and melanin was obtained at the treatment and control sites at pretreatment, posttreatment, and follow-up 6 weeks after the last injection. Thirty participants completed the study, reaching the required number for an adequately powered sample based on pilot study data analyses. Ten participants received only one injection, 27 received only two injections, and 13 received three injections of TAC. Analysis of covariance comparing the treatment vs control HSc posttreatment, controlling for pretreatment values and Fitzpatrick skin type, revealed a significant decrease in thickness and increase in elasticity of the treated compared with control HSc (P = .0003), but no significant difference in erythema or melanin. Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc. A regression model for repeated measures, controlling for pretreatment values and skin type, revealed no significant change in thickness, elasticity, erythema, or melanin during the 6-week follow-up. Although thickness decreased at both the treated and control HSc across time, there was a significantly greater reduction at the TAC injected HSc and a significantly greater increase in elasticity. Melanin significantly increased at both the treatment and control site. There was no significant change during the follow-up period of any of the HSc characteristics.",2020,"Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc.","['Fifty burn survivors with two scars (separated by nonscarred skin preferably on the contralateral side or an anatomically similar site) were selected based on high-frequency ultrasound thickness (>2.034 mm to ensure that the site was outside of the range of normal scar', 'Thirty participants completed the study, reaching the required number for an adequately powered sample based on pilot study data analyses', 'patient-matched usual care control scars', 'Adult Burn Survivors']","['Intralesional corticosteroid (triamcinolone acetonide [TAC]) injections', 'TAC', 'ml TAC', 'TAC injections', 'Triamcinolone Acetonide Injections']","['thickness of both the treated and control HSc', 'elasticity', 'erythema or melanin', 'thickness, elasticity, erythema, or melanin', 'thickness, elasticity, erythema, and melanin', 'Melanin', 'melanin', 'elasticity of the treated HSc', 'control HSc elasticity or erythema']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}]",,0.0315162,"Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc.","[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Nedelec', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, Montreal, Canada.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'LaSalle', 'Affiliation': 'Hôpital de réadaptation Villa Medica, Montreal, Canada.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Oliveira', 'Affiliation': 'Hôpital de réadaptation Villa Medica, Montreal, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, Canada.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa057']
213,32253184,"Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.","OBJECTIVES


Bimekizumab selectively neutralises both interleukin (IL)-17A and IL-17F. We report efficacy and safety in a phase IIb dose-ranging study in patients with active ankylosing spondylitis (AS).
METHODS


Adults with AS (fulfilling modified New York criteria) were randomised 1:1:1:1:1 to bimekizumab 16 mg, 64 mg, 160 mg, 320 mg or placebo every 4 weeks for 12 weeks (double-blind period). At week 12, patients receiving bimekizumab 16 mg, 64 mg or placebo were re-randomised 1:1 to bimekizumab 160 mg or 320 mg every 4 weeks to week 48; other patients continued on their initial dose (dose-blind period). The primary end point was Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 12 (non-responder imputation (NRI) for missing data).
RESULTS


303 patients were randomised: bimekizumab 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), 320 mg (n=61) or placebo (n=60). At week 12, significantly more bimekizumab-treated patients achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%; p<0.05 all comparisons; OR vs placebo 2.6-5.5 (95% CI 1.0 to 12.9)). A significant dose-response was observed (p<0.001). The primary end point was supported by all secondary efficacy outcomes. At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients. During the double-blind period, treatment-emergent adverse events occurred in 26/60 (43.3%) patients receiving placebo and 92/243 (37.9%) receiving bimekizumab.
CONCLUSIONS


Bimekizumab provided rapid and sustained improvements in key outcome measures in patients with active AS, with no unexpected safety findings versus previous studies.
TRIAL REGISTRATION NUMBER


NCT02963506.",2020,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","['Adults with AS (fulfilling modified New York criteria', 'patients with active AS', '303 patients', 'patients with active ankylosing spondylitis', 'patients with active ankylosing spondylitis (AS']","['bimekizumab', 'placebo', 'interleukin-17A and interleukin-17F with bimekizumab', 'ASAS40 vs placebo', 'bimekizumab 16 mg, 64 mg or placebo', 'Bimekizumab']","['interleukin (IL)-17A and IL-17F', 'adverse events', 'SpondyloArthritis international Society (ASAS) 40 response', 'efficacy and safety', 'ASAS40 response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.70834,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Department of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Farmer', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Baeten', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, UCB Pharma, Slough, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Goldammer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Coarse', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'Oortgiesen', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980']
214,32292492,"Extracorporeal Hemadsorption  versus  Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial.","Extracorporeal hemadsorption may reduce inflammatory reaction in cardiopulmonary bypass (CPB) surgery. Glucocorticoids have been used during open-heart surgery for alleviation of systemic inflammation after CPB. We compared intraoperative hemadsorption and methylprednisolone, with usual care, during complex cardiac surgery on CPB, for inflammatory responses, hemodynamics, and perioperative course. Seventy-six patients with prolonged CPB were recruited and randomized, with 60 included in final analysis. Allocation was into three groups: Methylprednisolone ( n  = 20), Cytosorb ( n  = 20), and Control group (usual care,  n  = 20). Proinflammatory (TNF- α , IL-1 β , IL-6, and IL-8) and anti-inflammatory (IL-10) cytokines which complement C5a, CD64, and CD163 expression by immune cells were analyzed within the first five postoperative days, in addition to hemodynamic and clinical outcome parameters. Methylprednisolone group, compared to Cytosorb and Control had significantly lower levels of TNF- α  (until the end of surgery,  p  < 0.001), IL-6 (until 48 h after surgery,  p  < 0.001), and IL-8 (until 24 h after surgery,  p  < 0.016). CD64 expression on monocytes was the highest in the Cytosorb group and lasted until the 5 th  postoperative day ( p  < 0.016). IL-10 concentration (until the end of surgery) and CD163 expression on monocytes (until 48 h after surgery) were the highest in the Methylprednisolone group ( p  < 0.016, for all measurements between three groups). No differences between groups in the cardiac index or clinical outcome parameters were found. Methylprednisolone more effectively ameliorates inflammatory responses after CPB surgery compared to hemadsorption and usual care. Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes. Hemadsorption with CytoSorb® was safe and well tolerated. This trial is registered with clinicaltrials.gov (NCT02666703).",2020,Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes.,"['cardiopulmonary bypass (CPB) surgery', 'Seventy-six patients with prolonged CPB']","['Glucocorticoids', 'Extracorporeal Hemadsorption  versus  Glucocorticoids', 'Methylprednisolone', 'intraoperative hemadsorption and methylprednisolone', 'Extracorporeal hemadsorption']","['levels of TNF- α', 'CD163 expression on monocytes', 'inflammatory responses', 'IL-8', 'safe and well tolerated', 'CD64 expression on monocytes', 'Proinflammatory (TNF- α , IL-1 β , IL-6, and IL-8) and anti-inflammatory (IL-10) cytokines which complement C5a, CD64, and CD163 expression by immune cells', 'IL-6', 'IL-10 concentration', 'inflammatory reaction']","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0018899', 'cui_str': 'Hemadsorption'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0108796', 'cui_str': 'Lymphocyte antigen CD64'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0009521', 'cui_str': 'C5a Complement'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",76.0,0.116329,Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes.,"[{'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Taleska Stupica', 'Affiliation': 'Clinical Department of Anaesthesiology and Perioperative Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Sostaric', 'Affiliation': 'Clinical Department of Anaesthesiology and Perioperative Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bozhinovska', 'Affiliation': 'Clinical Department of Anaesthesiology and Perioperative Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Rupert', 'Affiliation': 'Clinical Department of Anaesthesiology and Perioperative Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Bosnic', 'Affiliation': 'University of Ljubljana, Faculty of Computer and Information Science, Ljubljana, Slovenia.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Jerin', 'Affiliation': 'Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Alojz', 'Initials': 'A', 'LastName': 'Ihan', 'Affiliation': 'University of Ljubljana, Faculty of Medicine, Institute of Microbiology and Immunology, Ljubljana, Slovenia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Klokocovnik', 'Affiliation': 'Clinical Department of Cardio-Vascular Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Podbregar', 'Affiliation': 'Clinical Department of Anaesthesiology and Perioperative Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Cardiovascular therapeutics,['10.1155/2020/7834173']
215,32304001,Evaluation of adjunctive efficacy of diode laser in the treatment of peri-implant mucositis: a randomized clinical trial.,"Peri-implant disease may affect survival of dental implants. The aim of the study is to analyze the effectiveness of diode laser as a supportive modality to the non-surgical conventional treatment of peri-implant mucositis (PiM) and initial peri-implantitis (PI). Twenty-three patients with single implants suffering from PiM or initial PI were selected and randomly divided into two groups; control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980 nm. Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1). The average of PPD value for TG was 4.04 ± 0.54 mm at T0 and it was 2.98 ± 0.70 mm at T1. In the CG, PPD average was 3.8 ± 1.24 mm at T0 and was 3.54 ± 0.35 mm at T1. In TG, the BOP was positive in 44 sites at T0 and in 6 sites at T1. In CG, the BOP was positively observed in 52 sites at T0 and in 28 sites at T1. The 980-nm diode laser may be considered an adjunct to the conventional non-surgical treatments of PiM and initial PI.",2020,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"['peri-implant mucositis (PiM) and initial peri-implantitis (PI', 'peri-implant mucositis', 'Twenty-three patients with single implants suffering from PiM or initial PI']","['diode laser', 'control group (CG) received non-surgical conventional treatment, and test group (TG) received non-surgical conventional treatment and diode laser application with wavelength of 980\xa0nm']","['average of PPD value for TG', 'BOP', 'Probing pocket depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",23.0,0.0224006,Probing pocket depth (PPD) and bleeding on probing (BOP) were recorded at baseline (T0) and at 3 months follow-up (T1).,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tenore', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Montori', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mohsen', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy. ahmed.mohsen@uniroma1.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mattarelli', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome, Via Caserta 6, 00161, Rome, Italy.'}]",Lasers in medical science,['10.1007/s10103-020-03009-y']
216,31002426,Closed-loop insulin delivery in end-of-life care: a case report.,"BACKGROUND


Glucose management for people with diabetes approaching the end of life can be very challenging. The aim is to balance a minimally invasive approach with avoidance of symptomatic hypo- and hyperglycaemia.
CASE REPORT


We present a case of a hospitalized individual whose glucose was managed with closed-loop insulin delivery within a randomized controlled trial setting during a period of terminal illness. During the time in which closed-loop insulin delivery was used, glucose control was safe, with no glucose-related harm. The mean ± sd sensor glucose for this individual was 11.3 ± 4.3 mmol/l, percentage of time spent in target glucose range between 6 and 15 mmol/l was 70.5%, time spent in hypoglycaemia was 2.0% and time spent in significant hyperglycaemia >20 mmol/l was 2.6%.
CONCLUSION


Closed-loop systems can accommodate personalized glucose targets and highly variable insulin requirements. Factory-calibrated continuous glucose sensors and insulin pump therapy are less intrusive than finger-stick glucose measurements and insulin injections, respectively. Closed-loop systems may provide a safer and less burdensome approach to glucose management towards the end of life.",2019,"During the time in which closed-loop insulin delivery was used, glucose control was safe, with no glucose-related harm.",['people with diabetes'],"['glucose was managed with closed-loop insulin delivery', 'Factory-calibrated continuous glucose sensors and insulin pump therapy']","['time spent in hypoglycaemia', 'mean ± sd sensor glucose', 'time spent in target glucose range']",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0442614', 'cui_str': 'Factory (environment)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.0516168,"During the time in which closed-loop insulin delivery was used, glucose control was safe, with no glucose-related harm.","[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Bern University Hospital, Department of Diabetes Endocrinology, Clinical Nutrition and Metabolism, Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Wolfson Diabetes and Endocrine Clinic, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Bern University Hospital, Department of Diabetes Endocrinology, Clinical Nutrition and Metabolism, Bern, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13974']
217,31663156,Effectiveness of medication review on the number of drug-related problems in patients visiting the outpatient cardiology clinic: A randomized controlled trial.,"AIMS


To assess the effectiveness of medication review on the number of drug-related problems (DRPs) in outpatient cardiology patients.
METHODS


In this randomized controlled trial, a computer-assisted and pharmacist-led medication review with patient involvement (questionnaire and telephone call with pharmacist) was conducted in intervention patients prior to their visit to the cardiologist. The control group received usual care. Adult outpatient cardiology patients without support concerning the administration of medication, without a medication review in the past 6 months and who gave permission to access their electronic medication record were included. The primary outcome measure was the number of DRPs 1 month after the visit. Secondary outcome measures concerned the type of DRP and the type of medication involved in the DRPs.
RESULTS


In total, 75 patients (mean [standard deviation, SD] age 66.0 [12.5] years, 41% female) were included. Intervention (n = 90) and control group (n = 85) were comparable at baseline. The mean (SD) number of drugs used per patient was 7.9 (3.9). After 1 month, the mean (SD) number of DRPs was 0.3 (0.7) and 0.8 (1.0) and the median (range) number of DRPs was 0 (0-4) and 0 (0-4) in the intervention group and control group, respectively (P < .001). In the intervention group, 74% of the DRPs identified at T0 were solved at T1 vs 14% in the control group.
CONCLUSION


This randomized controlled trial suggests that a pharmacist-led medication review in patients with a scheduled visit to the outpatient cardiology clinic decreases the number of DRPs.",2020,"To assess the effectiveness of medication review on the number of drug-related problems (DRPs) in outpatient cardiology patients.
","['patients visiting the outpatient cardiology clinic', 'outpatient cardiology patients', '175 patients (mean (SD) age 66.0 (12.5) years, 41% female) were included', 'patients with a scheduled visit to the outpatient cardiology clinic decreases the number of DRPs', 'Adult outpatient cardiology patients without support concerning the administration of medication, without a medication review in the past six months and who gave permission to access their electronic medication record were included']","['computer-assisted and pharmacist-led medication review with patient involvement (questionnaire and telephone call with pharmacist', 'usual care']","['mean (SD) number of drugs used per patient', 'type of DRPs and the type of medication involved in the DRPs', 'mean (SD) number of DRPs', 'number of DRPs one month after the visit', 'median (range) number of DRPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0030699', 'cui_str': 'Patient Involvement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",175.0,0.116339,"To assess the effectiveness of medication review on the number of drug-related problems (DRPs) in outpatient cardiology patients.
","[{'ForeName': 'Victor Johan Bernard', 'Initials': 'VJB', 'LastName': 'Huiskes', 'Affiliation': 'Department of Pharmacy, Sint Maartenskliniek, The Netherlands.'}, {'ForeName': 'Cornelia Helena Maria', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Kruijtbosch', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, The Netherlands.'}, {'ForeName': 'Hendrik Tinus', 'Initials': 'HT', 'LastName': 'Ensing', 'Affiliation': 'Outpatient Pharmacy, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Meijs', 'Affiliation': 'Outpatient Pharmacy, St. Antonius ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Veronique Maria Mathea', 'Initials': 'VMM', 'LastName': 'Meijs', 'Affiliation': 'Outpatient Pharmacy, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'David Marinus', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bartholomeus Johannes Fredericus', 'Initials': 'BJF', 'LastName': 'van den Bemt', 'Affiliation': 'Department of Pharmacy, Sint Maartenskliniek, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14125']
218,31971403,Psychosocial screening and mental health in pediatric cancer: A randomized controlled trial.,"OBJECTIVE


Diagnosis and treatment of childhood cancer can impact the mental health of the family. Early psychosocial risk screening may help guide interventions. The primary aim of this study was to evaluate if an intervention (providing psychosocial risk information to the patient's treating team) would result in decreased depression symptoms in caregivers, in general, and relative to initial psychosocial risk. A secondary aim was to examine intervention effects in a small sample of patient and sibling self-reported outcomes.
METHODS


We randomly allocated families to the intervention group (IG, treating team received PAT summary) or control group (CG, no summary). One hundred and twenty-two caregivers of children newly diagnosed with cancer completed measures of depression and anxiety and psychosocial risk 2-4 weeks from diagnosis (T1) and 6 months later (T2). Patients and siblings completed self-report measures of depression and anxiety.
RESULTS


There was no significant difference in caregiver depression symptoms between the IG and CG at T2. However, in the context of psychosocial risk, caregivers in the IG showed improvement in depression scores compared to CG when risk was high near diagnosis ( M s = 6.68 vs. 9.76, respectively,  d  = .60). Similar results were found in anxiety scores. Intervention effects with patients and siblings were inconclusive.
CONCLUSIONS


Sharing psychosocial risk information with the treating team had measurable impact on mental health outcomes only if caregivers had initial high psychosocial risk. This study contributes to our understanding of mapping psychosocial screening and resources to improve outcomes in families managing childhood cancer. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,There was no significant difference in caregiver depression symptoms between the IG and CG at T2.,"['families managing childhood cancer', 'One hundred and twenty-two caregivers of children newly diagnosed with cancer completed measures of depression and anxiety and psychosocial risk 2-4 weeks from diagnosis (T1) and 6 months later (T2', 'pediatric cancer']","['Psychosocial screening and mental health', 'intervention group (IG, treating team received PAT summary) or control group (CG, no summary']","['mental health outcomes', 'caregiver depression symptoms', 'anxiety scores', 'depression scores', 'depression and anxiety']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0717152,There was no significant difference in caregiver depression symptoms between the IG and CG at T2.,"[{'ForeName': 'Maru', 'Initials': 'M', 'LastName': 'Barrera', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Hematology/Oncology.'}, {'ForeName': 'Eshetu G', 'Initials': 'EG', 'LastName': 'Atenafu', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hancock', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Aden', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Desjardins', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shama', 'Affiliation': 'Department of Social Work.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Division of Hematology/Oncology.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000825']
219,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


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


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


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


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
220,30851006,Take Control: A randomized trial evaluating the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes.,"AIM


To compare the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL (Gla-300) in people with inadequately controlled type 2 diabetes.
METHODS


Take Control (EudraCT number: 2015-001626-42) was a 24-week, multi-national, open-label, controlled, two-arm, parallel-group study in insulin-naïve and pre-treated participants, randomized 1:1 to a self- or physician-managed titration of Gla-300. The fasting self-monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant-reported outcomes (PROs).
RESULTS


At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self- and physician-managed groups, respectively, with an LS mean difference of -0.13% [95% confidence interval -0.2619 to -0.0004] (-1.4 mmol/mol [-2.863 to -0.004]), demonstrating non-inferiority (P < 0.0001) and superiority (P = 0.0247) of self- versus physician-managed titration. Significantly more of the self- than physician-managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self-management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self-managed group.
CONCLUSIONS


Self-managed titration of Gla-300 was superior to physician-managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.",2019,"In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self-management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self-managed group.
","['Take Control (EudraCT number: 2015-001626-42', 'people with inadequately controlled type 2 diabetes', 'patients with uncontrolled type 2 diabetes']","['self- or physician-managed titration of Gla-300', 'self- versus physician-managed titration of insulin glargine 300\u2009U/mL', 'self- versus physician-managed titration of insulin glargine 300\u2009U/mL (Gla-300']","['emotional burden, and similar hypoglycaemia frequency', 'SMPG target without hypoglycaemia', 'SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant-reported outcomes (PROs', 'total PRO scores', 'least squares (LS) mean HbA1c reduction', 'non-inferiority of glycated haemoglobin (HbA1c) change', 'Overall, hypoglycaemia incidence', 'efficacy and safety', 'fasting self-monitored plasma glucose (SMPG']","[{'cui': 'C3834230', 'cui_str': 'Take Control'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.0753101,"In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self-management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self-managed group.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell-Jones', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dauchy', 'Affiliation': 'Global Diabetes Division, Sanofi, Paris, France.'}, {'ForeName': 'Elías', 'Initials': 'E', 'LastName': 'Delgado', 'Affiliation': 'Department of Medicine, University of Oviedo, Spain.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dimitriadis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Frandsen', 'Affiliation': 'Department of Internal Medicine, Amager Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Luiza', 'Initials': 'L', 'LastName': 'Popescu', 'Affiliation': 'Global R&D Operations, Sanofi, Bucharest, Romania.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schultes', 'Affiliation': 'eSwiss Medical and Surgical Center, Department of Internal Medicine, Endocrinology, Diabetes and Metabolism, St Gallen, Switzerland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Strojek', 'Affiliation': 'Department of Internal Diseases, Diabetology and Cardiometabolic Diseases SMDZ, Zabrze, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Global Diabetes Division, Sanofi, Paris, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Roborel de Climens', 'Affiliation': 'Clinical Outcome Generation, Sanofi, Lyon, France.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, University Hospitals of Leicester, Leicester, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13697']
221,32241795,Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial.,"OBJECTIVES


To evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients.
METHODS


The incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices.
RESULTS


In the high-risk group, Classic (∆k€1.464, 95% CI -0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI -0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆-0.002, 95% CI -0.086 to 0.082) and Avant-Garde (∆-0.009, 95% CI -0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars.
CONCLUSIONS


The combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment.
TRIAL REGISTRATION NUMBER


NCT01172639.",2020,"In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated.","['low-risk patients', 'diagnosed patients with rheumatoid arthritis (RA', 'healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial', 'early rheumatoid arthritis']","['MTX without GCs (Tight-Step-Up, TSU', 'sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde', 'MTX', 'methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim', 'COBRA-like intensive remission induction schemes']","['cost-effectiveness', 'Healthcare costs', 'price of biosimilars', 'Quality-adjusted life years (QALYs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0206326', 'cui_str': 'Cobra'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.259848,"In the low-risk group, Slim was cheaper (∆k€-0.617, 95% CI -2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pazmino', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium sofia.pazmino@kuleuven.be.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Stouten', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'De Cock', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Joly', 'Affiliation': 'Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Van der Elst', 'Affiliation': 'Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Westhovens', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Verschueren', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Flanders, Belgium.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216874']
222,31096259,Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial.,"AIM


The aim of this double-blinded parallel randomised controlled trial was to compare the effect of different liners on 12-month pulp health outcomes after partial caries removal (PCR) with composite restorations in permanent molars.
METHODS


The study was registered at clinicaltrials.gov with registration No. NCT0328695 and conducted in the Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support. One hundred and ninety-eight participants (116 males, 82 females and age 14-54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin were randomised to calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC) groups after PCR. After a follow-up time of 12 months, success was defined as positive response to pulp sensibility and absence of periapical alterations.
RESULTS


Categorical variables were compared using chi-square test. Two analytical approaches were used, such as intention-to-treat and per-protocol approach. Success rates in per-protocol approach were 96.8, 96.5, and 94.6% for CH, RMGIC and DC groups, respectively with no significant difference between 3 groups (p = 0.811). None of the baseline variables had any significant influence on the treatment success.
CONCLUSION


Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival. Also, the success of the treatment is independent of the lining material used over the demineralized dentin.",2019,"CONCLUSION


Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival.","['One hundred and ninety-eight participants (116 males, 82 females and age 14-54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin', 'after Partial Caries Removal', 'Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support', 'partial caries removal (PCR) with composite restorations in permanent molars']","['calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC', 'Different Liners']","['positive response to pulp sensibility and absence of periapical alterations', 'Success rates', 'Pulpal Outcome', 'pulp vitality or restoration survival']","[{'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333523', 'cui_str': 'Deep caries (morphologic abnormality)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0016118', 'cui_str': 'Financial Support'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",198.0,0.383811,"CONCLUSION


Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival.","[{'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India, shwetagoelendo@gmail.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India.'}]",Caries research,['10.1159/000499131']
223,31691408,Preventing sleep deficit in adolescents: Long-term effects of a quasi-experimental school-based intervention study.,"Adolescents are at risk of sleep deficit, which has serious consequences for their daytime functioning. However, school-based interventions to improve sleep have shown limited success. This might be due to the content of the programmes (e.g., not targeting central factors such as daytime stress and technology use) or because changes have not been captured due to a lack of long-term follow-ups. Hence, the aim of this study was to evaluate the long-term effects of a school-based sleep education curriculum including time-management training. The study used a quasi-experimental design. Participants were 3,622 adolescents (mean age 13.7, 48% girls); 286 were in the intervention group and 3,336 were followed as a natural control group. Data were collected before the intervention and at a 1-year follow-up. We divided participants into three groups according to baseline sleep duration (calculated from self-reported bed- and wake times, minus sleep onset latency): insufficient (<7 hr), borderline (7-8 hr) and adequate (>8 hr). Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls. Sleep knowledge improved significantly in the intervention group but there were no changes in emotional sleep hygiene (e.g., bedtime worry) and perceived stress. Surprisingly, technology use increased and behavioural sleep hygiene worsened in the intervention group. Although the mechanisms of change need further investigation, the results of this study point to potential long-term benefits of school-based sleep programmes.",2020,Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls.,"['Participants were 3,622 adolescents (mean age 13.7, 48% girls); 286 were in the intervention group and 3,336 were followed as a natural control group', 'adolescents', 'divided participants into three groups according to baseline sleep duration (calculated from self-reported bed- and wake times, minus sleep onset latency): insufficient (<7\xa0hr), borderline (7-8\xa0hr) and adequate (>8\xa0hr']",['school-based sleep education curriculum'],"['emotional sleep hygiene (e.g., bedtime worry) and perceived stress', 'sleep deficit', 'behavioural sleep hygiene', 'Sleep knowledge', 'times less likely to report insufficient sleep']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]",286.0,0.0168591,Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls.,"[{'ForeName': 'Serena Valeria', 'Initials': 'SV', 'LastName': 'Bauducco', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Flink', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Boersma', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Linton', 'Affiliation': 'Örebro University, Örebro, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12940']
224,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


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


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


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


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


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
225,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


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


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


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
226,32295718,High dose trivalent influenza vaccine compared to standard dose vaccine in patients with rheumatoid arthritis receiving TNF-alpha inhibitor therapy and healthy controls: Results of the DMID 10-0076 randomized clinical trial.,"INTRODUCTION


Subjects with rheumatoid arthritis (RA) receiving tumor necrosis factor-inhibiting (TNFi) therapies are at risk for severe influenza, and may respond less well to influenza vaccine. We examined the safety and immunogenicity of high dose influenza vaccine (HD) compared to standard dose vaccine (SD) in participants with RA receiving stable TNFi.
METHODS


A randomized, double-blinded, Phase II study was conducted in adults with RA receiving TNFi, and healthy, gender and age-matched control subjects. Participants were immunized with HD (Sanofi Pasteur Fluzone High Dose [60 mcg × 3 strains]) or SD (Sanofi Pasteur Fluzone® [15 mcg × 3 strains]) intramuscularly (IM). A self-administered memory aid recorded temperature and systemic and local adverse events (AEs) for 8 days, and safety was evaluated and serum obtained to measure HAI activity on days 7, 21 and 180 days following vaccination.
RESULTS


A greater proportion of RA subjects who received HD seroconverted at day 21 compared to SD, although this was not statistically significant. GMT antibody responses in RA subjects who received HD compared to SD were greater for all strains on day 21, and this was significant for H1N1. Seroconversion rates and GMT values were not different between RA subjects and control subjects. There were no safety concerns for HD or SD in RA subjects, and RA-related symptoms did not differ between SD and HD recipients by a RA-symptom questionnaire (RAPID 3).
CONCLUSIONS


TNF-inhibitor therapy in people with RA did not appear to influence the immunogenicity of either SD or HD. Influenza seroconversion and GMT values were higher among RA subjects receiving HD compared to SD; however, differences were small and a larger study is needed to validate these findings. Given the apparent risk of increased influenza-related morbidity and mortality among immune compromised subjects, the higher GMT values generated by HD may be beneficial.",2020,"GMT antibody responses in RA subjects who received HD compared to SD were greater for all strains on day 21, and this was significant for H1N1.","['adults with RA receiving TNFi, and healthy, gender and age-matched control subjects', 'participants with RA receiving stable TNFi', 'patients with rheumatoid arthritis receiving TNF-alpha inhibitor therapy and healthy controls', 'Subjects with rheumatoid arthritis (RA) receiving', '×\xa03 strains']","['High dose trivalent influenza vaccine', 'vaccine', 'HD (Sanofi Pasteur Fluzone High Dose [60 mcg\xa0×\xa03 strains]) or SD (Sanofi Pasteur Fluzone® [15 mcg', 'influenza vaccine (HD', 'TNF-inhibitor therapy', 'tumor necrosis factor-inhibiting (TNFi) therapies', 'vaccine (SD']","['Influenza seroconversion and GMT values', 'Seroconversion rates and GMT values', 'GMT antibody responses', 'safety and immunogenicity', 'safety concerns for HD or SD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C4505396', 'cui_str': 'High-Dose Trivalent Influenza Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C2740348', 'cui_str': 'Fluzone High-Dose'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0797746,"GMT antibody responses in RA subjects who received HD compared to SD were greater for all strains on day 21, and this was significant for H1N1.","[{'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Stapleton', 'Affiliation': 'Department of Internal Medicine and Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States; Microbiology and Immunology, The University of Iowa, Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States; Research and Medical Services, Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States. Electronic address: jack-stapleton@uiowa.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine and Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tuetken', 'Affiliation': 'Department of Internal Medicine and Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States.'}, {'ForeName': 'Abbie R', 'Initials': 'AR', 'LastName': 'Bellamy', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States.'}, {'ForeName': 'Sonnie', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, United States.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Winokur', 'Affiliation': 'Department of Internal Medicine and Iowa City Veterans Affairs Medical Center, Iowa City, IA 52242, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.04.002']
227,30733088,"Parent report of provider HPV vaccine communication strategies used during a randomized, controlled trial of a provider communication intervention.","OBJECTIVE


To assess secondary, parent-reported outcomes from a randomized controlled trial (RCT) of a provider communication intervention aimed at improving adolescent HPV vaccination.
METHODS


A paper survey was provided to a random sample of 777 parents of adolescents from 8 control and 8 intervention clinics participating in the larger trial. Chi-square or Fisher's exact tests assessed associations between study arm and providers' HPV vaccine communication strategies, parents' vaccination attitudes and parent's HPV vaccine acceptance. Exploratory analyses assessed the association between receipt of 'very strong' or presumptive HPV vaccine recommendation (regardless of study arm) and parent's perceptions about their providers' vaccine communication, and parents' attitudes and acceptance of the HPV vaccine.
RESULTS


The response rate was 47%. There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine. Receipt of a 'very strong' recommendation was associated with greater perceived urgency for getting vaccinated, greater trust in the information received from the provider, decreased vaccine hesitancy, and increased vaccine receipt. Receipt of a presumptive recommendation was associated with a lower likelihood of having concerns about the vaccine's safety, lower vaccine hesitancy, and an increased likelihood of vaccination. Neither recommendation strategy appeared to negatively impact parents' visit experience or trust in the information being provided. Similar results were found in sub-analyses of vaccine hesitant parents.
CONCLUSIONS


Providing very strong, presumptive HPV vaccine recommendations is associated with improved parent vaccination attitudes and acceptance, and does not seem to have significant negative impacts, even among parents who are vaccine hesitant. Response bias in our sample could explain why there were no reported differences between study arms in parents' reports of how their adolescent's providers communicated about the HPV vaccine.",2019,"There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine.",['777 parents of adolescents from 8 control and 8 intervention clinics participating in the larger trial'],"['provider HPV vaccine communication strategies', 'provider communication intervention']","['HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine', 'response rate']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",777.0,0.10398,"There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine.","[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States. Electronic address: Amanda.dempsey@ucdenver.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Campagna', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.01.051']
228,30738645,Effectiveness of an intervention campaign on influenza vaccination of professionals in nursing homes: A cluster-randomized controlled trial.,"BACKGROUND


Seasonal influenza has a major individual and collective impact, especially among the elderly living in nursing homes. To prevent infection by influenza viruses, vaccination of residents and professionals is an essential measure. However, while the vaccination rates of residents are generally high (>85%), rates among professionals are generally approximately 20%. To evaluate the effectiveness of an intervention campaign on the improvement of the influenza vaccination rate of professionals, a regional intervention study was proposed for nursing homes during the 2014-15 season.
METHODS


Cluster-randomized controlled trial (with a nursing home representing a cluster). In the intervention group, a campaign on influenza vaccination was offered to staff, combining different teaching aids in a multimodal approach. In the control group, no intervention was proposed. The primary endpoint was the rate of influenza vaccination among staff. Before and after the study, professionals were asked to complete short questionnaires on their perceptions of influenza vaccination. A multilevel analysis was carried out to compare the vaccination rates between the 2 groups and their evolution before/after the winter period.
RESULTS


A total of 32 nursing homes were randomized, and 6 were excluded. Initial vaccination rates were 27.6% in the intervention group and 24.2% in the control group (p = 0.16). After the study, these rates increased to 33.7% and 22.9%, respectively, which was a relative difference of +22.1% in the intervention group compared to -5.4% in the control group, p = 0.0025.
CONCLUSIONS


Despite professionals' reluctance to be vaccinate, participation in a promotional campaign with a pragmatic approach has increased the rate of influenza vaccination. The approach will be offered to all nursing homes in the region after revision of the tools to enhance their ease of use and pedagogical messages focused on the direct benefits to professionals.",2019,Initial vaccination rates were 27.6% in the intervention group and 24.2% in the control group (p = 0.16).,"['nursing homes', '32 nursing homes', 'nursing homes during the 2014-15 season', 'elderly living in nursing homes']",['intervention campaign'],"['rate of influenza vaccination', 'rate of influenza vaccination among staff', 'vaccination rates', 'Initial vaccination rates']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0591469,Initial vaccination rates were 27.6% in the intervention group and 24.2% in the control group (p = 0.16).,"[{'ForeName': 'France', 'Initials': 'F', 'LastName': 'Borgey', 'Affiliation': 'CHU de Caen, CPias Normandie, Caen F-14000, France. Electronic address: borgey-f@chu-caen.fr.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Henry', 'Affiliation': 'CHU de Caen, CPias Normandie, Caen F-14000, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Lebeltel', 'Affiliation': 'CHU de Caen, CPias Normandie, Caen F-14000, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Lescure', 'Affiliation': 'CHU de Caen, Département filière gériatrique-Médecine, Caen F-14000, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Le Coutour', 'Affiliation': ""CHU de Caen, Service d'Hygiène Hospitalière, Caen F-14000, France; Université de Caen Normandie, Medical School, Caen F-14000, France.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Vabret', 'Affiliation': 'Université de Caen Normandie, Medical School, Caen F-14000, France; CHU de Caen, Laboratoire de Virologie, Caen F-14000, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Verdon', 'Affiliation': 'Université de Caen Normandie, Medical School, Caen F-14000, France; CHU de Caen, Service de Maladies Infectieuses, Caen F-14000, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Thibon', 'Affiliation': 'CHU de Caen, CPias Normandie, Caen F-14000, France.'}]",Vaccine,['10.1016/j.vaccine.2019.01.066']
229,31658396,"Safety, tolerability and pharmacokinetics and pharmacodynamics of HL2351, a novel hybrid fc-fused interleukin-1 receptor antagonist, in healthy subjects: A first-in-human study.","AIMS


We performed a first-in-human study with HL2351, a novel hybrid Fc-fused interleukin (IL)-1 receptor antagonist, to evaluate its tolerability, pharmacokinetics and pharmacodynamics (PD) after a single subcutaneous (SC) administration in healthy subjects.
METHODS


A randomized, double-blind, placebo- and active-controlled, dose-escalation study was conducted. Eligible subjects randomly received a single SC administration of HL2351 (1, 2, 4, 8 and 12 mg/kg) or placebo in a ratio of 8:2. Subjects in the active-controlled group received a single SC administration of anakinra at 100 mg. Serial blood samples were collected for pharmacokinetics and PD analyses. An ex-vivo activation test was performed to evaluate the PD using peripheral blood mononuclear cells treated with IL-1β. Anti-HL2351 antibodies were determined at baseline and 29 days postdose. Tolerability was assessed throughout the study.
RESULTS


HL2351 was eliminated more slowly than anakinra (terminal half-life: 27.21-45.28 vs 3.97 h). Serum concentrations of HL2351 were increased dose-proportionally. The mean apparent clearance of HL2351 were 0.6, 0.66, 0.75, 0.51, 0.65 L/h at 1, 2, 4, 8 and 12 mg/kg, respectively. The percent inhibition of IL-6 expression varied widely (range: 0-92.1%), showing no clear trend or discernible difference between HL2351, anakinra and placebo. HL2351 was well tolerated after a single SC administration.
CONCLUSION


HL2351 was well tolerated and showed linear pharmacokinetic characteristics after a single SC administration at doses up to 12 mg/kg in healthy subjects. HL2351 remained in the body 7-11 times longer than anakinra. HL2351 can be developed as a potential therapeutic alternative to anakinra.",2020,"The percent inhibition of IL-6 expression varied widely (range: 0-92.1%), showing no clear trend or discernible difference between HL2351, anakinra, and placebo.",['healthy subjects'],"['placebo', 'single SC administration of HL2351', 'HL2351']","['Safety, tolerability and pharmacokinetics and pharmacodynamics', 'tolerated', 'Tolerability', 'tolerability, pharmacokinetics (PK), and pharmacodynamics (PD', 'mean apparent clearance of HL2351', 'Serum concentrations of HL2351', 'percent inhibition of IL-6 expression', 'Anti-HL2351 antibodies', 'tolerated and showed linear pharmacokinetic characteristics', 'HL2351']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1628982', 'cui_str': 'Percent inhibition'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",,0.213589,"The percent inhibition of IL-6 expression varied widely (range: 0-92.1%), showing no clear trend or discernible difference between HL2351, anakinra, and placebo.","[{'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki Young', 'Initials': 'KY', 'LastName': 'Huh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Cho', 'Affiliation': 'Y Biologics, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji-Eun', 'Initials': 'JE', 'LastName': 'Cha', 'Affiliation': 'HANDOK Inc., Seoul, Republic of Korea.'}, {'ForeName': 'Se-Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'HANDOK Inc., Seoul, Republic of Korea.'}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Sup', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': 'Department of Laboratory Medicine, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunyee', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Protein Immunology Core Facility, Biomedical Research Institutes, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jieon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",British journal of clinical pharmacology,['10.1111/bcp.14161']
230,31658494,Pharmacokinetics of intravenous and inhaled salbutamol and tobramycin: An exploratory study to investigate the potential of exhaled breath condensate as a matrix for pharmacokinetic analysis.,"Concentrations of drugs acting in the lungs are difficult to measure, resulting in relatively unknown local pharmacokinetics. The aim of this study is to assess the potential of exhaled breath condensate (EBC) as a matrix for pharmacokinetic analysis of inhaled and intravenous medication. A 4-way crossover study was conducted in 12 volunteers with tobramycin and salbutamol intravenously and via inhalation. EBC and plasma samples were collected postdose and analysed for drug concentrations. Sample dilution, calculated using urea concentrations, was used to estimate the epithelial lining fluid concentration. Salbutamol and tobramycin were largely undetectable in EBC after intravenous administration and were detectable after inhaled administration in all subjects in 50.8 and 51.5% of EBC samples, respectively. Correction of EBC concentrations for sample dilution did not explain the high variability. This high variability of EBC drug concentrations seems to preclude EBC as a matrix for pharmacokinetic analysis of tobramycin and salbutamol.",2020,"Salbutamol and tobramycin were largely undetectable in EBC after intravenous administration and were detectable after inhaled administration in all subjects in 50.8% and 51.5% of EBC samples, respectively.",['12 volunteers with'],"['Salbutamol and tobramycin', 'tobramycin and salbutamol intravenously and via inhalation', 'exhaled breath condensate (EBC', 'intravenous and inhaled salbutamol and tobramycin']","['EBC and plasma samples', 'exhaled breath']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1629517', 'cui_str': 'Exhaled breath condensate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}]",12.0,0.0254204,"Salbutamol and tobramycin were largely undetectable in EBC after intravenous administration and were detectable after inhaled administration in all subjects in 50.8% and 51.5% of EBC samples, respectively.","[{'ForeName': 'Matthijs D', 'Initials': 'MD', 'LastName': 'Kruizinga', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Willem A J', 'Initials': 'WAJ', 'LastName': 'Birkhoff', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'van Esdonk', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Klarenbeek', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Cholewinski', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Nelemans', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Melloney J', 'Initials': 'MJ', 'LastName': 'Dröge', 'Affiliation': 'Ardena Bioanalytical Laboratory BV, Assen, the Netherlands.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Cohen', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Rob G J A', 'Initials': 'RGJA', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14156']
231,31659776,Impact of pharmaceutical care on the quality of life of patients with heart failure due to chronic Chagas disease: Randomized clinical trial.,"AIMS


Chronic Chagas disease (ChD) has high morbimortality and loss in quality of life due to heart failure (HF). Pharmaceutical care (PC) optimizes clinical treatment and can improve quality of life in HF. We evaluated if PC improves quality of life of patients with ChD and HF.
METHODS


Single-blinded, randomized, controlled trial that assigned adult patients with ChD and HF (81 patients; 61 ± 11 years; 48% male) to PC (n = 40) or standard care (n = 41). Quality of life according to SF-36 and Minnesota living with HF questionnaires, incidence of drug-related problems (DRPs), and adherence to medical treatment were determined at baseline and at every 3 months for 1 year. Intention-to-treat analyses were performed by mixed linear model to verify the treatment effect on the changes of these variables throughout the intervention period.
RESULTS


Relative changes from baseline to 1 year of follow-up of the domains physical functioning (+16.6 vs -8.5; P < .001), role-physical (+34.0 vs +5.2; P = .01), general health (+19.4 vs -6.1; P < .001), vitality (+11.5 vs. -5.8; P = .003), social functioning (+7.5 vs -13.3; P = .002), and mental health (+9.0 vs -3.7; P = .006) of the SF-36 questionnaire and the Minnesota living with HF questionnaire score (-12.7 vs +4.8; P < .001) were superior in the PC group than in the standard care group. Adherence to medical treatment increased as early as after 3 months of follow-up and DRPs incidence decreased after 6 months of follow-up only in the PC group.
CONCLUSIONS


Patients with ChD and HF who received PC presented improved quality of life, decrease in DRP frequency, and increase in medication adherence.",2020,"Adherence to medical treatment increased as early as after 3 months of follow-up and DRPs incidence decreased after 6 months of follow-up only in the PC group.
","['adult patients with ChD and HF (81 patients; 61±11 years; 48% male) to PC (n=40) or standard care (n=41', 'patients with heart failure due to chronic Chagas disease']","['pharmaceutical care', 'PC']","['DRPs incidence', 'general health', 'medication adherence', 'quality of life', 'social functioning', 'DRPs frequency', 'Adherence to medical treatment', 'vitality', 'mental health', 'Quality of life according to SF-36 and Minnesota Living with HF (MLHFQ) questionnaires, incidence of drug-related problems (DRPs), and adherence to medical treatment', 'role-physical', 'SF-36 questionnaire and the MLHFQ score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0041234', 'cui_str': 'Trypanosoma cruzi Infection'}]","[{'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0034380'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",81.0,0.0793131,"Adherence to medical treatment increased as early as after 3 months of follow-up and DRPs incidence decreased after 6 months of follow-up only in the PC group.
","[{'ForeName': 'Mayara da Costa', 'Initials': 'MDC', 'LastName': 'Chambela', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauro Felippe Felix', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernanda Martins', 'Initials': 'FM', 'LastName': 'Carneiro', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberto Rodrigues', 'Initials': 'RR', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Functional Genomics and Bioinformatics, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mariana Caldas', 'Initials': 'MC', 'LastName': 'Waghabi', 'Affiliation': 'Laboratory of Functional Genomics and Bioinformatics, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Verônica Gonçalves', 'Initials': 'VG', 'LastName': 'Mendes', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luciano de Souza', 'Initials': 'LS', 'LastName': 'Oliveira', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo Teixeira', 'Initials': 'MT', 'LastName': 'de Holanda', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andréa Silvestre', 'Initials': 'AS', 'LastName': 'de Sousa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andréa Rodrigues', 'Initials': 'AR', 'LastName': 'da Costa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sérgio Salles', 'Initials': 'SS', 'LastName': 'Xavier', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gilberto Marcelo Sperandio', 'Initials': 'GMS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberto Magalhães', 'Initials': 'RM', 'LastName': 'Saraiva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}]",British journal of clinical pharmacology,['10.1111/bcp.14152']
232,31206358,Association of Elevated Plasma Interleukin-18 Level With Increased Mortality in a Clinical Trial of Statin Treatment for Acute Respiratory Distress Syndrome.,"OBJECTIVE


A high plasma level of inflammasome mediator interleukin-18 was associated with mortality in observational acute respiratory distress syndrome cohorts. Statin exposure increases both inflammasome activation and lung injury in mouse models. We tested whether randomization to statin therapy correlated with increased interleukin-18 in the ARDS Network Statins for Acutely Injured Lungs from Sepsis trial.
DESIGN


Retrospective analysis of randomized controlled clinical trial.
SETTING


Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis.
PATIENTS


Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population.
INTERVENTIONS


Random assignment of rosuvastatin or placebo for up to 28 days or 3 days after ICU discharge.
MEASUREMENTS AND MAIN RESULTS


We measured plasma interleukin-18 levels in all Statins for Acutely Injured Lungs from Sepsis patients with sample available at day 0 (baseline, n = 683) and day 3 (after randomization, n = 588). We tested the association among interleukin-18 level at baseline, rising interleukin-18, and the impact of statin therapy on 60-day mortality, adjusting for severity of illness. Baseline plasma interleukin-18 level greater than or equal to 800 pg/mL was highly associated with 60-day mortality, with a hazard of death of 2.3 (95% CI, 1.7-3.1). Rising plasma interleukin-18 was also associated with increased mortality. For each unit increase in log2 (interleukin-18) at day 3 compared with baseline, the hazard of death increased by 2.3 (95% CI, 1.5-3.5). Subjects randomized to statin were significantly more likely to experience a rise in plasma interleukin-18 levels. Subjects with acute kidney injury, shock, low baseline interleukin-18, and those not receiving systemic corticosteroids were more likely to experience rising interleukin-18. Randomization to statin therapy was associated with rising in interleukin-18 in all of those subsets, however.
CONCLUSIONS


Elevated baseline plasma interleukin-18 was associated with higher mortality in sepsis-induced acute respiratory distress syndrome. A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.",2019,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"['Acute Respiratory Distress Syndrome', 'Acutely Injured Lungs from Sepsis trial', 'Subjects with acute kidney injury', 'Multicenter North American clinical trial, the ARDS Network Statins for Acutely Injured Lungs from Sepsis', 'Six hundred eighty-three subjects with infection-related acute respiratory distress syndrome, representing 92% of the original trial population']","['rosuvastatin or placebo', 'statin therapy']","['hazard of death', '60-day mortality', 'Baseline plasma interleukin-18 level', 'plasma interleukin-18 levels', 'mortality']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",683.0,0.63108,A rise in plasma interleukin-18 was also associated with increased mortality and was more common in subjects randomized to statin therapy in this clinical trial.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trtchounian', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Hunninghake', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Kaimal', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Kozikowski', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mogan', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Cardiovascular Research Institute, University of California, San Francisco, CA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Steingrub', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Joo Heon', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiichi', 'Initials': 'K', 'LastName': 'Nakahira', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Augustine M', 'Initials': 'AM', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Baron', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA.""}]",Critical care medicine,['10.1097/CCM.0000000000003816']
233,31667835,Babies in occiput posterior position are significantly more likely to require an emergency cesarean birth compared with babies in occiput transverse position in the second stage of labor: A prospective observational study.,"INTRODUCTION


Malposition complicates 2-13% of births at delivery, leading to increased obstetric interventions (cesarean section and instrumental delivery) and higher rates of adverse fetal and maternal outcomes. Limited data are available regarding the likely rates of obstetric intervention and subsequent neonatal and maternal outcomes of births with babies in persistent occiput posterior position vs those in persistent occiput transverse position. The UK Audit and Research trainee Collaborative in Obstetrics and Gynecology (UK-ARCOG) network set out to collect data prospectively at delivery on final mode of delivery and immediate outcomes.
MATERIAL AND METHODS


The UK-ARCOG network collected data on all births with malposition of the fetal head complicating the second stage of labor (n = 838) (occiput posterior/occiput transverse) requiring rotational vaginal operative birth or emergency cesarean to expedite delivery across 66 participating UK National Health Service maternity units over a 1-month period. The outcomes considered were the need for emergency cesarean section without a trial of instrumental delivery, success of the first method of delivery employed in achieving a vaginal delivery and neonatal/maternal outcomes.
RESULTS


Obstetricians regarded assistance with an operative vaginal delivery method to be unsafe in 15% of babies in occiput posterior position and 6.1% of babies in occiput transverse position, and they were delivered by primary emergency cesarean section. When vaginal delivery was deemed safe (defined as attempted assisted vaginal rotational delivery), the first instrument attempted was successful in 74.4% of occiput posterior babies and 79.3% of occiput transverse babies.
CONCLUSIONS


Our data facilitates decision making by obstetricians to increase safety of assisted rotational operative delivery of a malpositioned baby at initial assessment and in counseling women. Until data from a well-designed randomized controlled trial of instrumental delivery vs emergency cesarean section are available, this manuscript provides contemporaneous national data from a high resource setting within a structured training program, to assist the selection of an appropriate instrument/method for the delivery of a malpositioned baby.",2020,"RESULTS


Obstetricians regarded assistance with an operative vaginal delivery method to be unsafe in 15% of babies in occiput posterior position and 6.1% of babies in occiput transverse position, and they were delivered by primary emergency cesarean section.",['births with malposition of the fetal head complicating the second stage of labor (838) (occiput posterior / occiput transverse ) requiring rotational vaginal operative birth or emergency cesarean to expedite delivery across 66 participating UK National Health Service maternity units over a one-month period'],[],"['emergency cesarean birth', 'instrumental delivery, success of the first method of delivery employed in achieving a vaginal delivery and neonatal/maternal outcomes']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0333042', 'cui_str': 'Malposition (morphologic abnormality)'}, {'cui': 'C0231117', 'cui_str': 'Fetal head structure'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}]",[],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.0357568,"RESULTS


Obstetricians regarded assistance with an operative vaginal delivery method to be unsafe in 15% of babies in occiput posterior position and 6.1% of babies in occiput transverse position, and they were delivered by primary emergency cesarean section.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Tempest', 'Affiliation': ""Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': ""Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Dharani', 'Initials': 'D', 'LastName': 'Hapangama', 'Affiliation': ""Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13765']
234,32291291,Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services.,"OBJECTIVES


Common mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.
METHODS


Randomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee's manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.
RESULTS


A statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
CONCLUSION


PSI was effective in reducing sickness absence which was the primary outcome in this study.",2020,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","['100 employees with stress symptoms or CMDs', 'Randomisation was conducted at the OHS consultant level and each consultant was allocated into either', 'employees with common mental disorders or stress-related symptoms at work', 'employees with CMDs or stress-related symptoms', 'Common mental disorders (CMDs']","['CAU', 'giving a brief problem-solving intervention (PSI) or care as usual (CAU']","['earlier partial RTW and the mental health', 'sickness absence', 'self-registered sickness absence, return to work (RTW) and mental health', 'registered sickness absence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",100.0,0.155075,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.
","[{'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Keus van de Poll', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden marijke.keus.van.de.poll@ki.se.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nybergh', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bodin', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Lohela-Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Torgén', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106353']
235,32271833,A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.,"INTRODUCTION


An Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (group relaxation).
METHODS


Single-blind phase II randomized controlled trial (RCT) and nested qualitative study (ISRCTN registration number: 38971970). Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors were measured at baseline, after seven, 12 and 24 weeks. READY participants completed the purpose-built satisfaction questionnaire after 12 weeks. After trial completion, the control group also received READY. One-to-one participant interviews were conducted within three months of finishing the READY groups.
RESULTS


Four intervention groups were conducted with 39 participants (20 READY, 19 relaxation). Two patients (READY) withdrew before beginning the intervention due to unexpected work commitments. Feasibility and acceptability of READY were good, with high participant engagement and satisfaction. No statistical effects of READY were detected vs relaxation. Thirty participants were interviewed (18 READY; 12 relaxation + READY). Content data analysis revealed seven overarching themes: ""Attitudes towards participation""; ""Perceptions of program composition""; ""Program impacts on life domains""; ""Program active elements""; ""Program improvement trajectories""; ""Program differences and similarities""; ""Suggested READY improvements"".
CONCLUSION


READY was well accepted by MS patients with varied socio-demographic and clinical characteristics. Qualitative (but not quantitative) data provided evidence in favour of READY. Our findings will inform methodological and intervention refinements for the multi-centre RCT that will follow.",2020,No statistical effects of READY were detected vs relaxation.,"['people with multiple sclerosis', 'people with MS', 'Thirty participants', 'people with multiple sclerosis (READY for MS']",['active control intervention'],"['Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors', 'feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0652054,No statistical effects of READY were detected vs relaxation.,"[{'ForeName': 'Ambra Mara', 'Initials': 'AM', 'LastName': 'Giovannetti', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Quintas', 'Affiliation': 'Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tramacere', 'Affiliation': 'Department of Research and Clinical Development, Scientific Directorate, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Confalonieri', 'Affiliation': 'Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Messmer Uccelli', 'Affiliation': 'Italian Multiple Sclerosis Society and Research Foundation (FISM), Genoa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Solari', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Kenneth Ian', 'Initials': 'KI', 'LastName': 'Pakenham', 'Affiliation': 'School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.'}]",PloS one,['10.1371/journal.pone.0231380']
236,30952216,Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study.,"STUDY OBJECTIVES


We previously presented results from a randomized controlled trial that examined the effects of antidepressant medication plus cognitive behavioral therapy for insomnia (CBT-I) among patients with major depressive disorder (MDD) and insomnia. The current secondary analysis aims to examine whether circadian preference moderated the reduction in depression and insomnia symptom severity during this trial.
METHODS


A total of 139 adult participants with MDD and insomnia disorder were treated with antidepressant medication and randomized to receive 7 sessions of CBT-I or a control therapy (CTRL). Circadian preference (eveningness) was measured using the Composite Scale of Morningness (CSM). Depression symptom severity was assessed using the Hamilton Depression Rating Scale (HDRS); insomnia symptom severity was assessed using the Insomnia Severity Inventory (ISI). The moderating role of circadian preference on changes in HRSD and ISI was assessed via latent growth models within the framework of structural equation modeling.
RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups. The interaction between CSM and treatment group was also significant ( P  = .02), indicating that participants with greater evening preference in the CTRL group had significantly smaller HDRS reduction than those with greater evening preference in the CBT-I group. Circadian preference did not share significant associations with ISI (all  P  > .30).
CONCLUSIONS


Individuals with MDD and insomnia who have an evening preference are at increased risk for poor response to pharmacological depression treatment augmented with either CBT-I or CTRL behavioral insomnia treatment. However, evening types have better depression outcomes when treated with CBT-I than with CTRL for insomnia.",2019,"RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups.","['Insomnia Plus Antidepressant Medications', '139 adult participants with MDD and insomnia disorder', 'patients with major depressive disorder (MDD) and insomnia']","['CBT-I or a control therapy (CTRL', 'Cognitive Behavioral Therapy', 'antidepressant medication', 'antidepressant medication plus cognitive behavioral therapy']","['Circadian preference (eveningness', 'Hamilton Depression Rating Scale (HDRS); insomnia symptom severity', 'Circadian preference', 'Composite Scale of Morningness (CSM', 'depression and insomnia symptom severity', 'HDRS', 'HDRS reduction', 'Insomnia Severity Inventory (ISI', 'Depression symptom severity', 'depression outcomes']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",139.0,0.0391897,"RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups.","[{'ForeName': 'Lauren D', 'Initials': 'LD', 'LastName': 'Asarnow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Bei', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Krystal', 'Affiliation': 'School of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manber', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7716']
237,32161055,Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis.,"OBJECTIVES


To evaluate initial combination therapy with ambrisentan plus tadalafil (COMB) compared with monotherapy of either agent (MONO), and the utility of baseline characteristics and risk stratification in predicting outcomes, in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation.
METHODS


This post hoc analysis of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population. Time to clinical failure (TtCF) was assessed by baseline characteristics, treatment assignment and risk group (low, intermediate and high) at baseline and week 16. TtCF was compared between groups using Kaplan-Meier curves and Cox proportional hazards regression modelling.
RESULTS


The analysis included 216 patients (COMB, n=117; MONO, n=99). The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline. The risk of clinical failure was lower with COMB versus MONO in the baseline low-risk group (HR not calculated due to no events in COMB), baseline intermediate-risk group (HR 0.519, 95% CI 0.297 to 0.905) and in the week 16 low-risk group (HR 0.069, 95% CI 0.009 to 0.548).
CONCLUSIONS


The benefit of COMB over MONO was demonstrated in patients with CTD-PAH, particularly in those with typical PAH haemodynamic characteristics at baseline. COMB is appropriate for patients categorised as low risk and intermediate risk at baseline and low risk at follow-up.
TRIAL REGISTRATION NUMBER


NCT01178073.",2020,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","['Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population', 'connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH', '216 patients (COMB, n=117; MONO, n=99', 'patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation']","['ambrisentan plus tadalafil (COMB', 'monotherapy of either agent (MONO', 'ambrisentan and tadalafil', 'TtCF', 'Ambrisentan and Tadalafil']","['risk of clinical failure', 'Time to clinical failure (TtCF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009782', 'cui_str': 'Connective Tissue Diseases'}, {'cui': 'C1701938', 'cui_str': 'Associated pulmonary arterial hypertension (disorder)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0854255', 'cui_str': 'Systemic sclerosis pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",216.0,0.134752,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan kuwanam@nms.ac.jp.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Research and Development, Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Tokyo, Japan.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Brentford, London, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Services, Royal Free Hospital, London, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216274']
238,31162787,Cornea nerve fibre state determines analgesic response to tapentadol in fibromyalgia patients without effective endogenous pain modulation.,"BACKGROUND


Tapentadol is a centrally acting analgesic with μ-agonistic activity combined with noradrenaline reuptake inhibition. Its mechanism of action relies on improvement of descending pain inhibition. In the current study, tapentadol's ability to enhance conditioned pain modulation (CPM, an experimental measure of descending pain inhibition) was evaluated in fibromyalgia patients with absent or reduced CPM responses.
METHODS


A total of 34 fibromyalgia patients completed this double-blind trial. Patients were randomized to receive treatment with tapentadol sustained-release or placebo for a 3-month period with 1-month follow-up. At baseline, the cornea nerve fibre state (CNFS) was quantified to determine the presence of nerve fibre pathology and assess its value in the prediction of the analgesic response.
RESULTS


Tapentadol significantly increased CPM responses during treatment with an average increase from baseline of 20.5 ± 12.5% (tapentadol) versus 3.0 ± 11.2% (placebo; p = 0.042). No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol. Pain relief (a reduction in pain score ≥ 30%) was predicted by the presence of a normal CNFS (p = 0.035). Patients with an abnormal CNFS had no analgesic effect from tapentadol despite an increase in CPM.
CONCLUSIONS


In chronic pain patients with fibromyalgia, the increase in endogenous pain inhibition by tapentadol was translated into analgesia in patients with a normal CNFS. In those with abnormal CNFS, tapentadol treatment was without analgesic effect.
SIGNIFICANCE


In this double-blind randomized placebo-controlled trial, we showed that tapentadol significantly enhanced the descending pain inhibition in fibromyalgia patients. Tapentadol-induced pain relief was only present in patients with a normal CNFS.",2019,"No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol.","['fibromyalgia patients with absent or reduced CPM responses', 'chronic pain patients with fibromyalgia', 'patients with a normal CNFS', 'fibromyalgia patients', 'fibromyalgia patients without effective endogenous pain modulation', '34 fibromyalgia patients']","['Tapentadol', 'tapentadol sustained-release or placebo', 'tapentadol', 'placebo']","['Pain relief', 'pain inhibition', 'CPM', 'analgesic effect', 'CPM responses', 'absolute pain scores', 'cornea nerve fibre state (CNFS', 'endogenous pain inhibition', 'pain relief']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0027749', 'cui_str': 'Nerve Fibers'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}]",34.0,0.586201,"No treatment effect was observed for the absolute pain scores, however, analgesia responder rate analyses demonstrated a treatment effect in favour of tapentadol.","[{'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'van de Donk', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, the Netherlands.'}]","European journal of pain (London, England)",['10.1002/ejp.1435']
239,31657863,Clinical trial simulations of the interaction between cannabidiol and clobazam and effect on drop-seizure frequency.,"With this study, we aim to test the hypothesis that the effect of cannabidiol on drop-seizure frequency in patients with Lennox-Gastaut syndrome and Dravet syndrome could be attributed to a drug-drug interaction with clobazam. We performed clinical trial simulations for the effect of 20 mg/kg/day cannabidiol on drop-seizure frequency in patients with Lennox-Gastaut syndrome. We assumed that patients taking 10 or 20 mg clobazam would have a 2- to 7-fold increase in N-desmethylclobazam exposure, whereas patients not taking clobazam would have a median reduction in drop-seizure frequency and a variability in the percent reduction similar to the placebo group. The results show that the effect of cannabidiol on the median reduction in drop-seizure frequency in patients with Lennox-Gastaut syndrome may be explained by a drug-drug interaction with clobazam. This may have important implications for the use of cannabidiol and its Food and Drug Administration registration.",2020,We performed clinical trial simulations for the effect of 20 mg/kg/day cannabidiol on drop-seizure frequency in patients with Lennox-Gastaut syndrome.,"['patients with Lennox-Gastaut syndrome and Dravet syndrome', 'patients with Lennox-Gastaut syndrome']","['cannabidiol', 'clobazam']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome (disorder)'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}]",[],,0.0967351,We performed clinical trial simulations for the effect of 20 mg/kg/day cannabidiol on drop-seizure frequency in patients with Lennox-Gastaut syndrome.,"[{'ForeName': 'Kirsten Riber', 'Initials': 'KR', 'LastName': 'Bergmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Broekhuizen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14158']
240,31718297,Baseline Predictors of Low-Density Lipoprotein Cholesterol and Systolic Blood Pressure Goal Attainment After 1 Year in the ISCHEMIA Trial.,"BACKGROUND


Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described.
METHODS AND RESULTS


The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]).
CONCLUSIONS


In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.",2019,"Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]).",['individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy'],"['LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL']","['1-year SBP goal attainment', 'Low-Density Lipoprotein Cholesterol and Systolic Blood Pressure Goal Attainment', '1-year LDL-C goal', '1-year LDL-C goal attainment', 'systolic blood pressure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",5179.0,0.447978,"Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]).","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': 'New York University School of Medicine (J.D.N., J.S.H.).'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'Xiangqiong', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System, Boston, MA (W.E.B.).'}, {'ForeName': 'Sajeev C', 'Initials': 'SC', 'LastName': 'Govindan', 'Affiliation': 'Government Medical College, Kerala, India (S.C.G.).'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom (R.S.).'}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India (N.M.).'}, {'ForeName': 'Paulo C', 'Initials': 'PC', 'LastName': 'Rezende', 'Affiliation': 'Heart Instituto do Coracao, University of Sao Paulo, Brazil (P.C.R.).'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland (M.D.).'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, Idipaz, Madrid, Spain (J.L.L.-S.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': 'National Research Center for Cardiovascular Surgery, Moscow, Russia (O.B.).'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Pandit', 'Affiliation': 'Ram Manohar Lohia Hospital, Delhi, India (N.P.).'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': 'Montreal Heart Institute, QC, Canada (G.G.).'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Stone', 'Affiliation': ""Brigham and Women's Hospital, MA (P.H.S.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/UMKC, MO (J.A.S.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center and the Cardiovascular Research Foundation, NY (J.W.S.).'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Institute of Health, NHLBI, MD (J.L.F.).'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'New York University School of Medicine (J.D.N., J.S.H.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Stanford University School of Medicine, CA (D.J.M.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006002']
241,32297162,"Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study.","BACKGROUND


Introducing the principles of multimodal analgesic therapy is necessary to provide appropriate comfort for the patient after surgery. The main objective of the study was evaluating the influence of perioperative intravenous (i.v.) lidocaine infusion on postoperative morphine requirements during the first 48 h postoperatively in children undergoing major spine surgery.
MATERIALS AND METHODS


Prospective, randomized, double-blind study: 41 children, qualified to multilevel spine surgery, were randomly divided into two treatment groups: lidocaine and placebo (control). The lidocaine group received lidocaine as a bolus of 1.5 mg/kg over 30 minutes, followed by a continuous infusion at 1 mg/kg/h to 6 hours after surgery. The protocol of perioperative management was identical for all patients.
MEASUREMENTS


morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey).
RESULTS


Patient data did not differ demographically. Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization [95% CI 0.58 (0.19-0.78) mg/kg, p = 0.04]; postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet (p = 0.024) and solid diet (p = 0.012)], and accelerated the adoption of an upright position [sitting (p = 0.048); walking (p = 0.049)]. The SF-12 generic health survey did not differ between groups before operation, 2 months and 4 years after surgery.
CONCLUSIONS


Perioperative lidocaine administration, as a part of the applied analgesic therapy regimen, may decrease postoperative opioid demand and accelerates convalescence of children undergoing major surgery.",2020,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","['children undergoing major surgery', '41 children, qualified to multilevel spine surgery', 'major spine surgical procedures in children', 'children undergoing major spine surgery']","['Lidocaine', 'lidocaine', 'lidocaine and placebo (control']","['demand for morphine', 'postoperative morphine requirements', 'entire hospitalization', 'postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet', 'SF-12 generic health survey', 'morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey', 'adoption of an upright position [sitting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]",41.0,0.143157,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","[{'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Batko', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland. ilona.batko@poczta.onet.pl.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kościelniak-Merak', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Przemysław J', 'Initials': 'PJ', 'LastName': 'Tomasik', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kobylarz', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland.""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Wordliczek', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Jagiellonian University Medical College, Cracow, Poland.'}]",Pharmacological reports : PR,['10.1007/s43440-020-00100-7']
242,31188728,Prostate Transition Zone Fibrosis is Associated with Clinical Progression in the MTOPS Study.,"PURPOSE


Medications targeting androgen receptor activity (eg finasteride) or smooth muscle contractility (eg doxazosin) do not resolve lower urinary tract symptoms indicative of lower urinary tract dysfunction in an important subgroup of men. Recently fibrosis has been implicated as another pathobiology contributing to male lower urinary tract symptoms but to our knowledge no systematic studies have been done to assess fibrosis in the context of medical treatment. We determine whether fibrotic changes in the prostate transition zone are associated with an increased risk of clinical progression in participants treated with doxazosin, finasteride or finasteride plus doxazosin in the MTOPS (Medical Therapy of Prostatic Symptoms) study.
MATERIALS AND METHODS


Transition zone biopsy tissues from men who did or did not experience clinical progression on placebo, doxazosin, finasteride or combination therapy were assessed for collagen content and architectural changes using picrosirius red birefringence and CT-FIRE (Curvelet Transform-Fiber Extraction) analysis. Correlations were made with annotated demographic and clinical data. Statistical analyses were done with the Pearson correlation coefficient, ANOVA and the t-test.
RESULTS


High levels of wavy, aligned prostate transition zone collagen significantly correlated with an increased risk of clinical progression among MTOPS trial participants treated with doxazosin plus finasteride, particularly those with a high body mass index.
CONCLUSIONS


Fibrotic changes in the prostate transition zone are associated with an increased risk of clinical progression in men treated with doxazosin plus finasteride. Antifibrotic therapeutics might provide a new treatment approach in men with lower urinary tract dysfunction who do not respond to current medical treatment approaches.",2019,"RESULTS


High levels of wavy, aligned prostate transition zone collagen significantly correlated with an increased risk of clinical progression among MTOPS trial participants treated with doxazosin plus finasteride, particularly those with a high body mass index.
","['participants treated with', 'Transition zone biopsy tissues from men who did or did not experience clinical progression on', 'men with lower urinary tract dysfunction who do not respond to current medical treatment approaches']","['doxazosin', 'placebo, doxazosin, finasteride or combination therapy', 'doxazosin plus finasteride', 'doxazosin, finasteride or finasteride plus doxazosin']",['risk of clinical progression'],"[{'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0205825,"RESULTS


High levels of wavy, aligned prostate transition zone collagen significantly correlated with an increased risk of clinical progression among MTOPS trial participants treated with doxazosin plus finasteride, particularly those with a high body mass index.
","[{'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Macoska', 'Affiliation': 'Center for Personalized Cancer Therapy, University of Massachusetts, Boston, Massachusetts.'}, {'ForeName': 'Kristen S', 'Initials': 'KS', 'LastName': 'Uchtmann', 'Affiliation': ""George M. O'Brien Center for Benign Urologic Research, University of Wisconsin, Madison, Wisconsin.""}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Leverson', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Ricke', 'Affiliation': ""George M. O'Brien Center for Benign Urologic Research, University of Wisconsin, Madison, Wisconsin.""}]",The Journal of urology,['10.1097/JU.0000000000000385']
243,32294561,"Efficacy of incobotulinumtoxinA for the treatment of adult lower-limb post-stroke spasticity, including pes equinovarus.","BACKGROUND


Lower-limb spasticity can impair ambulation and gait, impacting quality of life.
OBJECTIVES


This ancillary analysis of the TOWER study (NCT01603459) assessed the efficacy of incobotulinumtoxinA for lower-limb post-stroke spasticity including pes equinovarus.
METHODS


Participants received escalating incobotulinumtoxinA doses (400-800U) across 3 injection cycles. Changes were compared for those treated in the lower limb (with/without upper-limb treatment) or the upper limb only or for participants treated or untreated for pes equinovarus. Outcome measures were those used in the seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment.
RESULTS


Among 132/155 (85%) participants with post-stroke spasticity, in cycles 1, 2 and 3, 99, 119 and 121 participants received lower-limb treatment with mean (SD) total limb incobotulinumtoxinA doses of 189.2 (99.2), 257.1 (115.0) and 321.3 (129.2) U, respectively. Of these, 80, 105 and 107, respectively, were treated for pes equinovarus. The mean (SD) improvement in REPAS lower-limb score was greater with treatment in the lower limb versus the upper limb only: -1.6 (2.1) versus-0.4 (1.4); -1.9 (1.9) versus -0.6 (1.6); -2.2 (2.2) versus -1.0 (0.0) (P=0.0005, P=0.0133 and P=0.3581; analysis of covariance [ANCOVA], between-group differences) in cycles 1, 2 and 3, respectively. For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P=0.0099; ANCOVA). At the end of cycle 3, 42% of participants walked independently and 63% achieved 2 of 2 lower-limb treatment goals (baseline 23% and 34%, respectively).
CONCLUSIONS


This study supports the efficacy of incobotulinumtoxinA for treatment of pes equinovarus and other patterns of lower-limb post-stroke spasticity.",2020,"For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P = 0.0099; ANCOVA).","['adult lower-limb post-stroke spasticity, including pes equinovarus']","['escalating incobotulinumtoxinA', 'incobotulinumtoxinA']","['ankle joint AS score', 'mean (SD) improvement in REPAS lower-limb score', 'seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment', '2 of 2 lower-limb treatment goals']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.121136,"For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P = 0.0099; ANCOVA).","[{'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'Raymond-Poincaré Hospital, AP-HP, University of Versailles Saint Quentin, Boulevard Raymond Poincaré, 92380 Garches, France. Electronic address: djamel.bensmail@aphp.fr.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wissel', 'Affiliation': 'Department of Neurology, Vivantes Hospital Spandau, Neue Bergstaße, 13585 Berlin, Germany. Electronic address: joerg.wissel@vivantes.de.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'Lapeyronie University Hospital, Avenue du Doyen Gaston Giraud, 34295 Montpellier, France; Euromov, Montpellier University, IFRH, Avenue du Pic Saint Loup, 34090 Montpellier, France. Electronic address: i-laffont@chu-montpellier.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Simon', 'Affiliation': 'Formerly of Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: simonolivier77@gmail.com.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Scheschonka', 'Affiliation': 'Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: Astrid.Scheschonka@merz.de.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Flatau-Baqué', 'Affiliation': 'Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: Birgit.Flatau-Baque@merz.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dressler', 'Affiliation': 'Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Street, 30625 Hannover, Germany. Electronic address: Dressler.Dirk@mh-hannover.de.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Simpson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, One Gustave Levy Place, New York 10029, USA. Electronic address: david.simpson@mssm.edu.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.005']
244,30686636,Effect of atorvastatin on humoral immune response to 23-valent pneumococcal polysaccharide vaccination in healthy volunteers: The StatVax randomized clinical trial.,"BACKGROUND


The immunomodulatory effects of statins on vaccine response remain uncertain. Therefore, the objective of this study was to determine if atorvastatin enhances pneumococcal-specific antibody titer following 23-valent pneumococcal polysaccharide vaccination.
METHODS


Double-blind, placebo-controlled, single-center randomized clinical trial entitled StatVax. Subjects were enrolled between June and July 2014 and followed up through September 2014. 33 healthy volunteers signed informed consent after volunteer sampling. 11 participants were excluded; 22 healthy volunteers without prior pneumococcal vaccination were enrolled and completed the study. Participants were randomized to receive a 28-day course of 40 mg atorvastatin (n = 12) or matching lactose placebo (n = 10). On day 7 of treatment, Pneumovax 23 was administered intramuscularly. The primary outcome was fold change in total pneumococcal-specific antibody titer determined by a ratio of post-vaccination titer over baseline titer. Secondary outcomes included serotype-specific pneumococcal antibody titer, seroconversion, complete blood counts (CBC), erythrocyte sedimentation rate (ESR), and serum cytokine analysis.
RESULTS


Of the 22 randomized patients (mean age, 23.86; SD, 4.121; 11 women [50%]), 22 completed the trial. Total anti-pneumococcal antibody titer in the atorvastatin group went from a baseline mean of 32.58 (SD, 15.96) to 147.7 (SD, 71.52) μg/mL at 21 days post-vaccination while titer in the placebo group went from a mean of 30.81 (SD, 13.04) to 104.4 (SD, 45) μg/mL. When comparing fold change between treatment groups, there was a significant increase in fold change of total anti-pneumococcal antibody titer in the atorvastatin group compared to the placebo group (2-way ANOVA, p = .0177).
CONCLUSIONS


Atorvastatin enhances antigen-specific primary humoral immune response to a T cell-independent pneumonia vaccination. Pending confirmation by larger cohort studies of target populations, peri-vaccination conventional doses of statins can become a novel adjuvant for poorly-immunogenic polysaccharide-based vaccines.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02097589.",2019,"When comparing fold change between treatment groups, there was a significant increase in fold change of total anti-pneumococcal antibody titer in the atorvastatin group compared to the placebo group (2-way ANOVA, p = .0177).
","['33 healthy volunteers signed informed consent after volunteer sampling', 'Subjects were enrolled between June and July 2014 and followed up through September 2014', 'healthy volunteers', '11 participants were excluded; 22 healthy volunteers without prior pneumococcal vaccination were enrolled and completed the study', 'Of the 22 randomized patients (mean age, 23.86; SD, 4.121; 11 women [50']","['placebo', 'atorvastatin (n\u202f=\u202f12) or matching lactose placebo', '23-valent pneumococcal polysaccharide vaccination', 'atorvastatin', 'Atorvastatin']","['fold change of total anti-pneumococcal antibody titer', 'fold change in total pneumococcal-specific antibody titer determined by a ratio of post-vaccination titer over baseline titer', 'serotype-specific pneumococcal antibody titer, seroconversion, complete blood counts (CBC), erythrocyte sedimentation rate (ESR), and serum cytokine analysis', 'Total anti-pneumococcal antibody titer', 'humoral immune response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1155229'}]",33.0,0.6363,"When comparing fold change between treatment groups, there was a significant increase in fold change of total anti-pneumococcal antibody titer in the atorvastatin group compared to the placebo group (2-way ANOVA, p = .0177).
","[{'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Wildes', 'Affiliation': 'University of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA. Electronic address: twildes@ufl.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Grippin', 'Affiliation': 'University of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Fasanya', 'Affiliation': 'University of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Health Cancer Center, Department of Radiation Oncology, Gainesville, FL, USA.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Dyson', 'Affiliation': 'University of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Brain Tumor Immunotherapy Program, Preston A. Wells, Jr. Center for Brain Tumor Therapy, Lillian S. Wells Department of Neurosurgery, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brantly', 'Affiliation': 'University of Florida MD-PhD Program, College of Medicine, Gainesville, FL, USA; University of Florida Division of Pulmonary and Critical Care Medicine, Gainesville, FL, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.01.023']
245,32293706,Exploring occupancy of the histamine H 3  receptor by pitolisant in humans using PET.,"BACKGROUND AND PURPOSE


BF2.649 (pitolisant, Wakix®) is a novel histamine H 3  receptor inverse agonist/antagonist recently approved for the treatment of narcolepsy disorder. The objective of the study was to investigate in vivo occupancy of H 3  receptors by BF2.649 using PET brain imaging with the H 3  receptor antagonist radioligand [ 11  C]GSK189254.
EXPERIMENTAL APPROACH


Six healthy adult participants were scanned with [ 11  C]GSK189254. Participants underwent a total of two PET scans on separate days, 3 h after oral administration of placebo or after pitolisant hydrochloride (40 mg). [ 11  C]GSK189254 regional total distribution volumes were estimated in nine brain regions of interest with the two tissue-compartment model with arterial input function using a common V ND  across the regions. Brain receptor occupancies were calculated with the Lassen plot.
KEY RESULTS


Pitolisant, at the dose administered, provided high (84 ± 7%; mean ± SD) occupancy of H 3  receptors. The drug was well-tolerated, and participants experienced few adverse events.
CONCLUSION AND IMPLICATIONS


The administration of pitolisant (40 mg) produces a high occupancy of H 3  receptors and may be a new tool for the treatment of a variety of CNS disorders that are associated with mechanisms involving H 3  receptors.",2020,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"['Humans Using Positron Emission Tomography', 'Six healthy adult participants']",['placebo or after pitolisant hydrochloride'],"['vivo H3R occupancy', 'Brain receptor occupancies']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}]","[{'cui': 'C0062739', 'cui_str': 'Histamine H3 Receptor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",6.0,0.0585618,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rusjan', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Sabioni', 'Affiliation': 'Translational Addiction Research Laboratory, CAMH, Toronto, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Ciano', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Mansouri', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boileau', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Laveillé', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Capet', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Duvauchelle', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}]",British journal of pharmacology,['10.1111/bph.15067']
246,32286894,Effects of Cacao By-Products and a Modest Weight Loss Intervention on the Concentration of Serum Triglycerides in Overweight Subjects: Proof of Concept.,"Therapeutic approaches to decrease serum triglyceride (TG) concentrations are not successful mainly due to poor adherence or adverse effects of therapies. In consequence, the search for new low-cost and safer therapeutic alternatives is mandatory. Dark chocolate and cacao have shown promising results improving lipid profiles. Recently, using cacao by-products to reduce elevated cardiometabolic risk markers in an animal model of obesity induced by a high-fat diet and fructose, we showed that TGs, low-density lipoprotein cholesterol, and the TG/high-density lipoprotein (HDL) ratio decreased, suggesting that cacao by-products improved the metabolic function of obese animals. Based on these results, as a proof of concept, a blinded placebo-controlled study was implemented to explore the effects of cacao by-products on anthropometric and biochemical variables in a group of overweight subjects participating in a program composed of reduced-calorie-diet counseling plus a simple aerobic exercise plan. The results showed that counseling induced weight and abdominal circumference reductions in both groups. TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group. The TG/HDL cholesterol ratio changed markedly (1.5) in the experimental group. The results reported suggest the use of cacao by-products as an alternative for the treatment of hypertriglyceridemia.",2020,"TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group.","['Overweight Subjects', 'overweight subjects participating in a program composed of']","['Cacao By-Products and a Modest Weight Loss Intervention', 'reduced-calorie-diet counseling plus a simple aerobic exercise plan']","['elevated cardiometabolic risk markers', 'weight and abdominal circumference reductions', 'Concentration of Serum Triglycerides', 'serum triglyceride (TG) concentrations', 'TGs, low-density lipoprotein cholesterol, and the TG/high-density lipoprotein (HDL) ratio', 'TG', 'TG/HDL cholesterol ratio', 'lipid profiles']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.0224022,"TGs did not change in the control group; however, TG decreased significantly by 54.9 mg/dL (27.9%) in the experimental group.","[{'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'León-Flores', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Nayelli', 'Initials': 'N', 'LastName': 'Nájera', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pérez', 'Affiliation': 'Unit of Metabolism and Nutritional Support, Hospital Juarez, Mexico City, Mexico.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Pardo', 'Affiliation': 'Unit of Metabolism and Nutritional Support, Hospital Juarez, Mexico City, Mexico.'}, {'ForeName': 'Fiacro', 'Initials': 'F', 'LastName': 'Jimenez', 'Affiliation': 'Health Norms Direction, ISSSTE, Mexico City, Mexico.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Diaz-Chiguer', 'Affiliation': 'Health Norms Direction, ISSSTE, Mexico City, Mexico.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'School of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hidalgo', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Meaney', 'Affiliation': 'Integral Caardiometabolic Research Laboratory, Research and Posgraduate Studies Section, School of Medicine, National Polytechnique Institute, Mexico City, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2019.0201']
247,32119192,Early inhaled budesonide in extremely preterm infants decreases long-term respiratory morbidity.,"BACKGROUND


There is no strict correlation between early bronchopulmonary dysplasia and long-term respiratory disease. Early inhaled corticosteroids seem to reduce the incidence of bronchopulmonary dysplasia, but the long-term outcome remains unknown.
RESEARCH QUESTION


The aim of this study was to evaluate the effect of early inhaled corticosteroids on chronic respiratory morbidity.
METHODS


Fifty-nine survivors from the Prague cohort included in Neonatal European Study of Inhaled Steroids underwent further follow-up comprising of respiratory morbidity monitoring during the first 2 years of life followed by objective lung function testing performed at the age of 5.9 years (range 5-7 years). Both outcomes were pursued and finalized before the unblinding of budesonide subgroups.
RESULTS


Fifty randomized (budesonide vs placebo group, 56% vs 44%) survivors were included in the study. Spirometry was successfully performed in 48 children. No statistically significant differences were found in the lung function test (forced expiratory flow [FEF] - FEF 75  , FEF 50,  FEF 25  , and FEF 25-75;  FEV 1  , forced vital capacity [FVC], FEV 1  /FVC) although mild trend to the improvement of expiratory flow pattern was observed in the budesonide group (median z-score of FEV 1  /FVC -0.376 vs -0.983, P = .13; median z-score of FEF 25-75  -1.004 vs -1.458, P = .13; median z-score of FEF 75  -0.527 vs -0.996, P = .17). Children assigned to budesonide had a significantly lower rate of symptoms of chronic lung disease (34.6% vs 68.2%; P = .04) than children assigned to placebo.
INTERPRETATION


Our study suggests that early inhaled budesonide was associated with the trend to the improvement of functional lung parameters and with a lower rate of symptoms of chronic lung disease within the first 2 years of life.",2020,"No statistically significant differences were found in the lung function test (forced expiratory flow [FEF] - FEF 75  , FEF 50,  FEF 25  , and FEF 25-75;  FEV 1  , forced vital capacity [FVC], FEV 1  /FVC) although mild trend to the improvement of expiratory flow pattern was observed in the budesonide group (median z-score of FEV 1  /FVC","['48 children', 'Fifty-nine survivors from the Prague cohort included in Neonatal European Study of Inhaled Steroids underwent further follow-up comprising of respiratory morbidity monitoring during the first 2 years of life followed by objective lung function testing performed at the age of 5.9 years (range 5-7 years', 'extremely preterm infants']","['budesonide', 'budesonide vs placebo', 'FVC', 'corticosteroids']","['lung function test (forced expiratory flow [FEF] - FEF 75  , FEF 50,  FEF 25  , and FEF 25-75;  FEV 1  , forced vital capacity [FVC], FEV 1  /FVC', 'expiratory flow pattern', 'decreases long-term respiratory morbidity', 'chronic respiratory morbidity', 'rate of symptoms of chronic lung disease', 'functional lung parameters', 'incidence of bronchopulmonary dysplasia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}]",48.0,0.217697,"No statistically significant differences were found in the lung function test (forced expiratory flow [FEF] - FEF 75  , FEF 50,  FEF 25  , and FEF 25-75;  FEV 1  , forced vital capacity [FVC], FEV 1  /FVC) although mild trend to the improvement of expiratory flow pattern was observed in the budesonide group (median z-score of FEV 1  /FVC","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Tukova', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Centre for Follow-Up Care of Ex-Preterm Babies, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Smisek', 'Affiliation': 'Division of Neonatology, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Zlatohlavkova', 'Affiliation': 'Division of Neonatology, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Plavka', 'Affiliation': 'Division of Neonatology, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Markova', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Centre for Follow-Up Care of Ex-Preterm Babies, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}]",Pediatric pulmonology,['10.1002/ppul.24704']
248,32283692,Oral Hygiene in a Sample of Children/Adolescents Living in Family-Homes from the Province of Milan (Italy): A Pilot Study.,"OBJECTIVE


This pilot study is a prospective controlled clinical trial, designed to evaluate the short-term clinical results (the plaque index) of an educational/motivational program for home oral hygiene, directed to children and adolescents who live in family-homes.
METHODS


The setting of the project was the province of Milan (Italy), where two family-homes were selected. The study group included 26 children (16 females and 10 males) aged between 7 and 15 years, of Italian nationality, from the family-home communities. The control group included 26 children (15 females and 11 males, aged between 7 and 15 years) of Italian nationality, matched for age and gender distribution with the study group, that were not in a socially disadvantaged condition. Collection of the plaque index (PI) was performed at t0. Then, all basic oral hygiene instructions were given to all children/adolescents and their educators. Education and motivation were repeated in the same way after 4-7 weeks (T1), and after 10-12 weeks (T2). The PI was taken also at T1 and T2.
RESULTS


An improvement in the PI was generally found in both groups, but there was no statistically significant difference between the two groups over time. Multivariate analysis of variance (MANOVA) revealed a statistically significant effect of time [F (1, 52) = 90.73,  p  < 0.001], regardless of the assignment group, in consequence of which the plaque index presented a moderate and significant improvement.
CONCLUSION


The present data confirm the validity of the educational/motivational program to improve oral hygiene in children/adolescents, regardless of the assignment group.",2020,"An improvement in the PI was generally found in both groups, but there was no statistically significant difference between the two groups over time.","['26 children (16 females and 10 males) aged between 7 and 15 years, of Italian nationality, from the family-home communities', 'children and adolescents who live in family-homes', '26 children (15 females and 11 males, aged between 7 and 15 years) of Italian nationality, matched for age and gender distribution with the study group, that were not in a socially disadvantaged condition', 'children/adolescents', 'Children/Adolescents Living in Family-Homes from the Province of Milan (Italy']","['Oral Hygiene', 'educational/motivational program']","['PI', 'plaque index (PI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",26.0,0.039399,"An improvement in the PI was generally found in both groups, but there was no statistically significant difference between the two groups over time.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nota', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, via Olgettina 48, 20132 Milan, Italy.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Bosco', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, via Olgettina 48, 20132 Milan, Italy.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Ehsani', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, via Olgettina 48, 20132 Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Giugliano', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, via Olgettina 48, 20132 Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Moreo', 'Affiliation': 'Dental School, Milano-Bicocca University, 20132 Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Tecco', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, via Olgettina 48, 20132 Milan, Italy.'}]",Dentistry journal,['10.3390/dj8020033']
249,30638797,"Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up.","BACKGROUND


A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90 months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20-45 years of age.
METHODS


Participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo (Day1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events (AEs) were collected using vaccination report cards (VRCs) for 15 days following each vaccination. Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study.
RESULTS


Of 3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study. Four participants (two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15 days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients (37.6% vs 27.8%), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups (46.8% vs 45.1%). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups, and within normal ranges.
CONCLUSION


The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45 years of age, consistent with findings from global trials and safety surveillance studies.
TRIAL REGISTRATION


clinicaltrials.gov; NCT00834106.",2019,"The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45 years of age, consistent with findings from global trials and safety surveillance studies.
","['Chinese women 20-45\u202fyears of age', '3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study', 'Chinese women during 90\u202fmonths of follow-up', 'Participants']","['qHPV vaccine', 'qHPV vaccine or placebo', 'quadrivalent human papillomavirus vaccine', 'placebo']","['Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs', 'Pregnancy outcomes, fetal/infant SAEs, and new medical conditions']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4517894', 'cui_str': '856 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",3006.0,0.734598,"The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45 years of age, consistent with findings from global trials and safety surveillance studies.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: chenwen@cicams.ac.cn.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, 1 Xueshi Road, Hangzhou 310006, China. Electronic address: xiex@zju.edu.cn.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Cancer Center, Sun Yat-sen University, 651 Dongfeng Road East, Guangzhou 510060, China. Electronic address: liujh@sysucc.org.cn.'}, {'ForeName': 'Jingran', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China.""}, {'ForeName': 'Shaoming', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: wangshaoming@cicams.ac.cn.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: Xue.yan.liao@merck.com.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Shou', 'Affiliation': 'MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: qiong.shou@merck.com.'}, {'ForeName': 'Minghuan', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: Ming.huan.zheng@merck.com.'}, {'ForeName': 'Alfred J', 'Initials': 'AJ', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China. Electronic address: weilhpku@163.com.""}, {'ForeName': 'Youlin', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: qiaoy@cicams.ac.cn.'}]",Vaccine,['10.1016/j.vaccine.2018.12.030']
250,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
251,32101663,Pembrolizumab for Early Triple-Negative Breast Cancer.,"BACKGROUND


Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear.
METHODS


In this phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 patients; the pembrolizumab-chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 patients; the placebo-chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. The primary end points were a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population.
RESULTS


At the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab-chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo-chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab-chemotherapy group and 46 of 390 patients (11.8%) in the placebo-chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively.
CONCLUSIONS


Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. (Funded by Merck Sharp & Dohme [a subsidiary of Merck]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).",2020,"Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively.
","['patients with early triple-negative breast cancer', 'Early Triple-Negative Breast Cancer', '2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive']","['neoadjuvant therapy with four cycles of pembrolizumab', 'placebo plus neoadjuvant chemotherapy', 'adjuvant pembrolizumab or placebo', 'doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide', 'pembrolizumab', 'placebo-chemotherapy', 'pembrolizumab or placebo', 'pembrolizumab plus neoadjuvant chemotherapy', 'Pembrolizumab', 'pembrolizumab to neoadjuvant chemotherapy', 'paclitaxel and carboplatin', 'pembrolizumab-chemotherapy group) or placebo', 'pembrolizumab-chemotherapy']","['incidence of treatment-related adverse events', 'pathological complete response at the time of definitive surgery and event-free survival', 'death', 'local or distant recurrence', 'pathological complete response', 'disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.636498,"Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McArthur', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Liyi', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Karantza', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Gursel', 'Initials': 'G', 'LastName': 'Aktan', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dent', 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': ""From Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1910549']
252,32271843,Adaptive responses of histone modifications to resistance exercise in human skeletal muscle.,"Exercise training causes epigenetic changes in skeletal muscle, although it is unclear how resistance exercise (RE) affects histone modifications. The present study was carried out to investigate the effects of acute RE and RE training on gene expression profiles and histone modifications in human skeletal muscle. Healthy male adults were assigned to acute RE (n = 9, age = 20.5±4.3yr, BMI = 28.0±6.8kg/m2) or RE training (n = 21, age = 23.7±2.5yr, BMI = 24.2±2.7kg/m2) groups. Biopsy samples were obtained from the vastus lateralis muscle before and three hours after a single bout of acute RE, or 3-days after 10 weeks of RE training. RNA sequencing analysis revealed that 153 genes with GO terms including muscle development, stress response, metabolism, cell death, and transcription factor were significantly up-regulated (+291% vs. pre-acute RE) upon acute RE. Expressions of these genes were also greater (+9.6% vs. pre-RE training, p<0.05) in RE trained subjects. Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels. Interestingly, the distribution of acetylated H3 was found to be up-regulated as compared to the level of total H3 after RE training (+40%, p<0.05). These results indicate that a single bout of RE drastically alters both gene expressions and histone modifications in human skeletal muscle. It is also suggested that enhanced histone acetylation is closely related to up-regulation of gene expressions after RE training.",2020,"Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels.","['human skeletal muscle', 'Healthy male adults were assigned to acute RE (n = 9, age ']","['Exercise training', 'RE training', 'resistance exercise']","['muscle development, stress response, metabolism, cell death, and transcription factor']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0949649', 'cui_str': 'Muscular Development'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",,0.0231295,"Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels.","[{'ForeName': 'Changhyun', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Department of Kinesiology, McMaster University, Ontario, Canada.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Shimizu', 'Affiliation': 'Department of Sports and Health Science, Matsumoto University, Nagano, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Kawano', 'Affiliation': 'Department of Sports and Health Science, Matsumoto University, Nagano, Japan.'}, {'ForeName': 'Hyo Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Healthy Ageing, Korea National Sport University, Seoul, Korea.'}, {'ForeName': 'Chang Keun', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'Exercise and Metabolism Research Center, Zhejiang Normal University, Jinhua, China.'}]",PloS one,['10.1371/journal.pone.0231321']
253,31296908,Caffeine intake modulates the functioning of the attentional networks depending on consumption habits and acute exercise demands.,"Consume of stimulants (as caffeine) is very usual in different contexts where the performers have to take quick and accurate decisions during physical effort. Decision-making processes are mediated by the attentional networks. An experiment was carried out to examine the effect of caffeine intake on attention (alerting, orienting, and executive control) as a function of consumption habit under two physical exertion conditions (rest vs. aerobic exercise). Two groups of participants with different caffeine consumption profiles (moderate consumers vs. low consumers) performed the Attention Network Test-Interactions under four different conditions regarding activity (rest vs. exercise) and intake (caffeine vs. placebo). Results showed that whereas exercise led to faster reaction times (RT) in all cases, caffeine intake accelerated RT but only at rest and in moderate caffeine consumers. More importantly, caffeine intake reduced the alertness effect in moderate consumers only at the rest condition. No interactions between Intake and Activity were observed in the other attentional networks, with exercise reducing orienting independently of caffeine intake, which suggests that physical exercise and caffeine are different modulators of attention but can interact. Caffeine intake had differential effects on reaction speed at rest and during physical exercise depending on the individual consumption habit. On the basis of these finding it seems that mainly alertness is modulated differently by internal and external ""arousing"" conditions.",2019,"No interactions between Intake and Activity were observed in the other attentional networks, with exercise reducing orienting independently of caffeine intake, which suggests that physical exercise and caffeine are different modulators of attention but can interact.",['Two groups of participants with different caffeine consumption profiles (moderate consumers vs. low consumers'],"['Attention Network Test-Interactions under four different conditions regarding activity (rest vs. exercise) and intake (caffeine vs. placebo', 'caffeine', 'stimulants (as caffeine', 'Caffeine']","['attention (alerting, orienting, and executive control', 'alertness effect', 'faster reaction times (RT']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0229675,"No interactions between Intake and Activity were observed in the other attentional networks, with exercise reducing orienting independently of caffeine intake, which suggests that physical exercise and caffeine are different modulators of attention but can interact.","[{'ForeName': 'Florentino', 'Initials': 'F', 'LastName': 'Huertas', 'Affiliation': 'Department of Physical Education & Sport Sciences, Catholic University of Valencia ""San Vicente Mártir"", Valencia, Spain. florentino.huertas@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Department of Physical Education & Sport Sciences, Catholic University of Valencia ""San Vicente Mártir"", Valencia, Spain.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Moratal', 'Affiliation': 'Department of Physical Education & Sport Sciences, Catholic University of Valencia ""San Vicente Mártir"", Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiañez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}]",Scientific reports,['10.1038/s41598-019-46524-x']
254,31300656,Reduction of physiological stress by urban green space in a multisensory virtual experiment.,"Although stress is an increasing global health problem in cities, urban green spaces can provide health benefits. There is, however, a lack of understanding of the link between physiological mechanisms and qualities of urban green spaces. Here, we compare the effects of visual stimuli (360 degree virtual photos of an urban environment, forest, and park) to the effects of congruent olfactory stimuli (nature and city odours) and auditory stimuli (bird songs and noise) on physiological stress recovery. Participants (N = 154) were pseudo-randomised into participating in one of the three environments and subsequently exposed to stress (operationalised by skin conductance levels). The park and forest, but not the urban area, provided significant stress reduction. High pleasantness ratings of the environment were linked to low physiological stress responses for olfactory and to some extent for auditory, but not for visual stimuli. This result indicates that olfactory stimuli may be better at facilitating stress reduction than visual stimuli. Currently, urban planners prioritise visual stimuli when planning open green spaces, but urban planners should also consider multisensory qualities.",2019,"High pleasantness ratings of the environment were linked to low physiological stress responses for olfactory and to some extent for auditory, but not for visual stimuli.",['Participants (N\u2009=\u2009154) were pseudo-randomised into participating in one of the three environments and subsequently exposed to stress (operationalised by skin conductance levels'],"['visual stimuli', 'congruent olfactory stimuli (nature and city odours) and auditory stimuli (bird songs and noise']",[],"[{'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]",[],360.0,0.0228538,"High pleasantness ratings of the environment were linked to low physiological stress responses for olfactory and to some extent for auditory, but not for visual stimuli.","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hedblom', 'Affiliation': 'Department of Forest Resource Management, Swedish University of Agricultural Sciences, Umeå, Sweden. marcus.hedblom@slu.se.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Gunnarsson', 'Affiliation': 'Department of Biological and Environmental Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Iravani', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Knez', 'Affiliation': 'Department of Occupational Health Sciences and Psychology, University of Gävle, Gävle, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Thorsson', 'Affiliation': 'Division of Applied Acoustics, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}]",Scientific reports,['10.1038/s41598-019-46099-7']
255,31300667,Human gut microbiome changes during a 10 week Randomised Control Trial for micronutrient supplementation in children with attention deficit hyperactivity disorder.,"It has been widely hypothesized that both diet and the microbiome play a role in the regulation of attention-deficit/hyperactivity disorder (ADHD) behaviour. However, there has been very limited scientific investigation into the potential biological connection. We performed a 10-week pilot study investigating the effects of a broad spectrum micronutrient administration on faecal microbiome content, using 16S rRNA gene sequencing. The study consisted of 17 children (seven in the placebo and ten in the treatment group) between the ages of seven and 12 years, who were diagnosed with ADHD. We found that micronutrient treatment did not drive large-scale changes in composition or structure of the microbiome. However, observed OTUs significantly increased in the treatment group, and showed no mean change in the placebo group. The differential abundance and relative frequency of Actinobacteria significantly decreased post- micronutrient treatment, and this was largely attributed to species from the genus Bifidobacterium. This was compensated by an increase in the relative frequency of species from the genus Collinsella. Further research is required to establish the role that Bifidobacterium contribute towards neuropsychiatric disorders; however, these findings suggest that micronutrient administration could be used as a safe, therapeutic method to modulate Bifidobacterium abundance, which could have potential implications for modulating and regulating ADHD behaviour. Our pilot study provides an initial observation into this area of research, and highlights an interesting avenue for further investigation in a larger cohort. Furthermore, these novel results provide a basis for future research on the biological connection between ADHD, diet and the microbiome.",2019,"The differential abundance and relative frequency of Actinobacteria significantly decreased post- micronutrient treatment, and this was largely attributed to species from the genus Bifidobacterium.","['17 children (seven in the placebo and ten in the treatment group) between the ages of seven and 12 years, who were diagnosed with ADHD', 'children with attention deficit hyperactivity disorder']","['placebo', 'micronutrient supplementation', 'broad spectrum micronutrient administration']",['faecal microbiome content'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",17.0,0.0413144,"The differential abundance and relative frequency of Actinobacteria significantly decreased post- micronutrient treatment, and this was largely attributed to species from the genus Bifidobacterium.","[{'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Stevens', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago Christchurch, P.O. Box 4345, Christchurch, New Zealand. aaron.stevens@otago.ac.nz.'}, {'ForeName': 'Rachel V', 'Initials': 'RV', 'LastName': 'Purcell', 'Affiliation': 'Department of Surgery, University of Otago Christchurch, P.O. Box 4345, Christchurch, New Zealand.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Darling', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Matthew J F', 'Initials': 'MJF', 'LastName': 'Eggleston', 'Affiliation': 'Mental Health Division, Canterbury District Health Board, Private Bag 4733, Christchurch, New Zealand.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago Christchurch, P.O. Box 4345, Christchurch, New Zealand.'}, {'ForeName': 'Julia J', 'Initials': 'JJ', 'LastName': 'Rucklidge', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}]",Scientific reports,['10.1038/s41598-019-46146-3']
256,31285526,Static magnetic stimulation of the primary motor cortex impairs online but not offline motor sequence learning.,"Static magnetic fields (SMFs) are known to alter neural activity, but evidence of their ability to modify learning-related neuroplasticity is lacking. The present study tested the hypothesis that application of static magnetic stimulation (SMS), an SMF applied transcranially via a neodymium magnet, over the primary motor cortex (M1) would alter learning of a serial reaction time task (SRTT). Thirty-nine participants took part in two experimental sessions separated by 24 h where they had to learn the SRTT with their right hand. During the first session, two groups received SMS either over contralateral (i.e., left) or ipsilateral (i.e., right) M1 while a third group received sham stimulation. SMS was not applied during the second session. Results of the first session showed that application of SMS over contralateral M1 impaired online learning as compared to both ipsilateral and sham groups, which did not differ. Results further revealed that application of SMS did not impair offline learning or relearning. Overall, these results are in line with those obtained using other neuromodulatory techniques believed to reduce cortical excitability in the context of motor learning and suggest that the ability of SMS to alter learning-related neuroplasticity is temporally circumscribed to the duration of its application.",2019,"Results of the first session showed that application of SMS over contralateral M1 impaired online learning as compared to both ipsilateral and sham groups, which did not differ.",['Thirty-nine participants took part in two experimental sessions separated by 24\u2009h where they had to learn the SRTT with their right hand'],"['static magnetic stimulation (SMS', 'Static magnetic fields (SMFs', 'Static magnetic stimulation', 'SMS either over contralateral (i.e., left) or ipsilateral (i.e., right) M1 while a third group received sham stimulation']","['cortical excitability', 'application of SMS over contralateral M1 impaired online learning']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C4505477', 'cui_str': 'Online Learning'}]",39.0,0.0203264,"Results of the first session showed that application of SMS over contralateral M1 impaired online learning as compared to both ipsilateral and sham groups, which did not differ.","[{'ForeName': 'Angélina', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': 'Department of Pediatrics, Sherbrooke University, 3001-12th Ave. North, Sherbrooke, Canada.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Proulx-Bégin', 'Affiliation': ""Department of Psychology, Montreal University, 90 Ave. Vincent d'Indy, Montréal, Canada.""}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Hamel', 'Affiliation': 'Department of Pediatrics, Sherbrooke University, 3001-12th Ave. North, Sherbrooke, Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'De Beaumont', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Pavillon Roger-Gaudry C.P, 6128, Montréal, Canada.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Bernier', 'Affiliation': ""Faculty of Physical Activity Sciences, Sherbrooke University, 2500 de l'Université Blvd., Sherbrooke, Canada.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Lepage', 'Affiliation': 'Department of Pediatrics, Sherbrooke University, 3001-12th Ave. North, Sherbrooke, Canada. jean-francois.lepage@usherbrooke.ca.'}]",Scientific reports,['10.1038/s41598-019-46379-2']
257,31592997,Effect of Community-Based Group Exercise Interventions on Standing Balance and Strength in Independent Living Older Adults.,"BACKGROUND AND PURPOSE


Many interventions to improve mobility in older adults often include exercises to address underlying impairments such as strength deficits. Task-oriented exercise interventions that focus more on walking and stepping tasks that may be encountered in the community have been considered for improving mobility in older adults. The main purpose was to examine the effect of task-oriented and impairment-based group exercise interventions on standing balance and lower extremity muscle strength.
METHODS


This is an ancillary study to a cluster-randomized clinical trial. Participants included 107 older adults. Participants were randomized by facility to 1 of 2 different interventions, or a waitlist control group. The On the Move (OTM) task-oriented intervention consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and stretching exercises. The standard of care impairment-based exercise intervention (STD) consisted of warm-up, strength, endurance, and stretching exercises. Postural sway and balance measures were recorded before and after the 12-week interventions. An accelerometer was used to collect postural sway for 6 different standing balance conditions. A portable load cell was used to assess lower extremity muscle strength for 3 muscle groups.
RESULTS AND DISCUSSION


The OTM group had a significant reduction in sway acceleration during most of the balance conditions over the 12-week period, whereas the STD had smaller, nonsignificant reductions. Both exercise interventions had a significant reduction in sway compared with the waitlist control group in at least 1 balance condition. The OTM and STD groups had significant increases in hip abduction strength during the intervention and the STD group also had an increase in knee extension strength. The waitlist group had a significant reduction in strength in all muscle groups during the 12-week period. Strength changes in both exercise groups were significantly different from the waitlist group but not from each other.
CONCLUSION


Both exercise intervention groups had an improvement in standing balance and lower extremity strength when compared with a waitlist group that did not receive exercise. Although the exercise groups did not significantly differ from each other, the OTM exercise group showed a trend toward improvement in static standing balance conditions.",2019,The OTM and STD groups had significant increases in hip abduction strength during the intervention and the STD group also had an increase in knee extension strength.,"['Participants included 107 older adults', 'older adults', 'Living Older Adults']","['exercise intervention', 'task-oriented and impairment-based group exercise interventions', 'OTM exercise', 'Task-oriented exercise interventions', 'Community-Based Group Exercise Interventions', 'Move (OTM) task-oriented intervention consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and stretching exercises', 'care impairment-based exercise intervention (STD) consisted of warm-up, strength, endurance, and stretching exercises', 'waitlist control group']","['static standing balance conditions', 'knee extension strength', 'Postural sway and balance measures', 'hip abduction strength', 'sway acceleration', 'Standing Balance and Strength', 'strength', 'extremity muscle strength', 'standing balance and lower extremity strength', 'standing balance and lower extremity muscle strength']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",107.0,0.020761,The OTM and STD groups had significant increases in hip abduction strength during the intervention and the STD group also had an increase in knee extension strength.,"[{'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Sparto', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Whitney', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000221']
258,30709725,Needle-free delivery of influenza vaccine using the Med-Jet® H4 is efficient and elicits the same humoral and cellular responses as standard IM injection: A randomized trial.,"BACKGROUND


Needle-free vaccine delivery systems have many potential advantages including increased vaccine compliance and decreased risk of needlestick injuries and syringe reuse. The Med-Jet® H4 is a gas-powered, auto-disabling disposable syringe jet injector. The Med-Jet family of products are currently being used in dermatology, podiatry, pain management and veterinary practices. The objectives of this study were to assess patient attitudes, time-efficiency, safety and immunogenicity of the seasonal influenza vaccine delivered by Med-Jet compared to the traditional needle-and-syringe.
METHODS


A total of 80 patients were randomized 2:1:1 to receive a commercial trivalent vaccine by Med-Jet or needle injection from a single-dose or multi-dose vial. Patient attitudes were assessed pre-randomization and post-immunization. Safety data were collected for 21 days post-immunization. Efficiency of vaccine administration was measured through a time-and-motion study. Humoral and cellular responses were assessed on Days 0 and 21.
RESULTS


Overall, the participants readily accepted Med-Jet vaccination despite greater frequency of transient local reactions (eg: redness, swelling) immediately following immunization. Vaccine administration took slightly longer with the Med-Jet, but this difference decreased over time. Geometric mean hemagglutination inhibition titers, seroconversion and seroprotection rates in the Med-Jet and needle groups were equivalent for all influenza strains in the vaccine. Microneutralization responses were also essentially identical. There were no significant differences between the groups in the frequency of functional CD4 + T cells, memory subset distribution or poly-functionality.
CONCLUSIONS


These data suggest that the Med-Jet is an acceptable means of delivering seasonal influenza vaccine. The system was attractive to subjects, rapidly learned by skilled vaccine nurses and elicited both humoral and cellular responses that were indistinguishable from those elicited with needle injection. While other studies have assessed the humoral response to jet injection of influenza vaccine, to our knowledge, this study is the first to assess the cellular aspect of this response. (ClinTrials.gov-NCT03150537).",2019,"There were no significant differences between the groups in the frequency of functional CD4 + T cells, memory subset distribution or poly-functionality.
",['80 patients'],"['commercial trivalent vaccine by Med-Jet or needle injection from a single-dose or multi-dose vial', 'seasonal influenza vaccine delivered by Med-Jet compared to the traditional needle-and-syringe', 'Vaccine']","['Geometric mean hemagglutination inhibition titers, seroconversion and seroprotection rates', 'Humoral and cellular responses', 'frequency of functional CD4\u202f+\u202fT cells, memory subset distribution or poly-functionality', 'patient attitudes, time-efficiency, safety and immunogenicity', 'Microneutralization responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.0332557,"There were no significant differences between the groups in the frequency of functional CD4 + T cells, memory subset distribution or poly-functionality.
","[{'ForeName': 'Janna R', 'Initials': 'JR', 'LastName': 'Shapiro', 'Affiliation': 'Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC H4A 3J1, Canada; Department of Microbiology & Immunology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Hodgins', 'Affiliation': 'Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC H4A 3J1, Canada; Department of Experimental Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Hendin', 'Affiliation': 'Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC H4A 3J1, Canada; Department of Microbiology & Immunology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC H4A 3J1, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Menassa', 'Affiliation': 'Medical International Technologies Canada (MIT Canada), 1872 Beaulac Street, Saint-Laurent, QC H4R 2E7, Canada.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Menassa', 'Affiliation': 'Medical International Technologies Canada (MIT Canada), 1872 Beaulac Street, Saint-Laurent, QC H4R 2E7, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Menassa', 'Affiliation': 'Medical International Technologies Canada (MIT Canada), 1872 Beaulac Street, Saint-Laurent, QC H4R 2E7, Canada.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Pereira', 'Affiliation': 'JRL Research & Consulting Inc., Toronto, ON, Canada.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ward', 'Affiliation': 'Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC H4A 3J1, Canada; Department of Microbiology & Immunology, McGill University, Montreal, QC, Canada; Vaccine Study Centre, Research Institute of the McGill University Health Centre, Montreal, QC, Canada. Electronic address: brian.ward@mcgill.ca.'}]",Vaccine,['10.1016/j.vaccine.2019.01.039']
259,32290880,Using fundraising incentives and point-of-purchase nutrition promotion to improve food choices among school families in restaurants: a pilot and feasibility study.,"OBJECTIVE


To assess the feasibility and efficacy of in-restaurant interventions aiming to promote healthy choices via fundraising incentives benefiting school wellness programmes and point-of-purchase nutrition promotion.
DESIGN


Twelve schools were randomly assigned to one of the two intervention periods: Fundraising Incentive (FI) donated funds for visiting the study restaurant and Fundraising-Healthy Eating Incentive (F-HEI) included FI with additional funds given when selecting a healthier item. Both conditions included point-of-purchase nutrition promotions. Families were recruited to attend their designated intervention and complete a survey. Feasibility was assessed based on recruitment and participation, implementation fidelity and intervention acceptability. Efficacy was assessed by comparing participant receipts between intervention periods and by comparing overall restaurant sales during intervention v. two no-intervention time frames.
SETTING


Fast-casual restaurant in Southern California.
PARTICIPANTS


Parents with children attending participating schools.
RESULTS


Eighty-one families visited the restaurant during the intervention, with sixty-six completing surveys. All study activities were implemented successfully, but school family participation in the intervention was low (0·95 %). Among participants completing surveys, all indicated satisfaction with the programme. The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2. Results were similar but did not reach statistical significance when comparing the interventions to Comparison 1.
CONCLUSIONS


Results support potential efficacy of this programme, but more research is needed to inform feasibility. Fidelity and acceptability data supported feasibility, but participation rates were low in this initial study. Methods evaluating this intervention with a greater proportion of parents should be considered.",2020,"The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2.","['Eighty-one families visited the restaurant during the intervention, with sixty-six completing surveys', 'Fast-casual restaurant in Southern California', 'Parents with children attending participating schools', 'school families in restaurants', 'Twelve schools']","['restaurant interventions', 'fundraising incentives and point-of-purchase nutrition promotion', 'Fundraising Incentive (FI) donated funds for visiting the study restaurant and Fundraising-Healthy Eating Incentive (F-HEI) included FI with additional funds given when selecting a healthier item']","['percentage of healthier items ordered', 'Efficacy', 'recruitment and participation, implementation fidelity and intervention acceptability']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016816', 'cui_str': 'Fund Raising'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",81.0,0.0238933,"The percentage of healthier items ordered was significantly greater during both FI (χ2 = 5·97, P = 0·01) and F-HEI (χ2 = 8·84, P = 0·003) v. Comparison 2.","[{'ForeName': 'Shawna L', 'Initials': 'SL', 'LastName': 'McNally', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, University at Buffalo, Buffalo, NY14214, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bowman', 'Affiliation': 'Virginia Department of Education, James Monroe Building, Richmond, VA23219, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Beleche', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA02111, USA.'}, {'ForeName': 'Anjali A', 'Initials': 'AA', 'LastName': 'Patel', 'Affiliation': 'Department of Research, Accents on Health, Inc. (dba Healthy Dining), San Diego, CA92123, USA.'}]",Public health nutrition,['10.1017/S1368980019004609']
260,32275730,Effects of peer tutoring on middle school students' mathematics self-concepts.,"The effects of peer tutoring on students' mathematics self-concepts were examined. The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program. A pretest posttest control group design was employed. Study participants included 376 students from grades 7 to 9 (12 to 15 years old). No statistically significant differences were reported between the pretest and the posttest for any of the control groups. Statistically significant improvements were reported for all grades for the experimental groups. An average increment of 13.4% was reported for students in the experimental group, and the overall effect size was reported to be medium (Hedges' g = 0.48). No statistically significant differences were reported across grades for the experimental group. The main conclusion of this study is that same-age and reciprocal peer tutoring may be very beneficial for middle school students' mathematics self-concepts. Several recommendations for field practitioners emanated from the study: use same-age and reciprocal tutoring over cross-age and fixed peer tutoring; schedule tutoring programs for four weeks or less with two to four sessions of 25 minutes or less per week for each tutoring session; and, include a control group in research studies.",2020,The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program.,"[""middle school students' mathematics self-concepts"", 'Study participants included 376 students from grades 7 to 9 (12 to 15 years old']",['peer tutoring'],['overall effect size'],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",376.0,0.0160382,The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program.,"[{'ForeName': 'Lidon', 'Initials': 'L', 'LastName': 'Moliner', 'Affiliation': 'Department of Education, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alegre', 'Affiliation': 'Department of Education, Valladolid University, Valladolid, Spain.'}]",PloS one,['10.1371/journal.pone.0231410']
261,32150670,Effect of pressure rise time on ventilator parameters and gas exchange during neonatal ventilation.,"BACKGROUND


Pressure rise time (PRT), also known as slope time to the peak inflating pressure can be set on some modern neonatal ventilators. On other ventilators, PRT is determined by the set circuit flow. Changing slope time can affect mean airway pressure (MAP), oxygenation, and carbon dioxide elimination. Our aim was to investigate the effect of PRT on ventilator parameters and gas exchange during volume-guaranteed ventilation.
METHODS


In a crossover study, 12 infants weighing greater than 2 kg were ventilated using a Dräger Babylog VN500 ventilator with synchronized intermittent positive pressure ventilation with volume guarantee (SIPPV-VG) and pressure support ventilation with volume guarantee (PSV-VG). During both modes PRTs between 0.08 and 0.40 seconds were used in 15-minute epochs. Data from the ventilator and patient monitors were downloaded with 1- and 100-Hz sampling rate and analyzed using the Python computer language.
RESULTS


During PSV-VG, longer PRTs were associated with longer inspiratory time (P < .0001) and with lower peak inflating pressure (PIP; P = .003), but the MAP was similar. During SIPPV-VG the PIP was not significantly different; however, MAP was lower with longer PRT (P = .001). With a short PRT (0.08 seconds), the PIP was higher during PSV-VG than during SIPPV-VG (19.8 vs 16.5 mbar; P = .042). There were no significant differences in tidal volume delivery, respiratory rate, minute volume, oxygen saturations, or end-tidal CO 2  with different PRTs in either mode.
CONCLUSIONS


During SIPPV-VG or PSV-VG, using short or long PRTs affects some ventilation parameters but does not significantly change oxygenation or carbon dioxide elimination.",2020,"During PSV-VG, longer PRTs were associated with longer inspiratory time (P < .0001) and with lower peak inflating pressure (PIP; P = .003), but the MAP was similar.",['12 infants weighing greater than 2\u2009kg were ventilated using a'],"['PRT', 'Dräger Babylog VN500 ventilator with synchronized intermittent positive pressure ventilation with volume guarantee (SIPPV-VG) and pressure support ventilation with volume guarantee (PSV-VG']","['mean airway pressure (MAP), oxygenation, and carbon dioxide elimination', 'tidal volume delivery, respiratory rate, minute volume, oxygen saturations, or end-tidal CO 2  with different PRTs', 'longer inspiratory time', 'PIP', 'peak inflating pressure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0428679', 'cui_str': 'Minute volume (observable entity)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",12.0,0.058097,"During PSV-VG, longer PRTs were associated with longer inspiratory time (P < .0001) and with lower peak inflating pressure (PIP; P = .003), but the MAP was similar.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chong', 'Affiliation': 'Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kayser', 'Affiliation': 'Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': 'Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Morley', 'Affiliation': 'Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, The Rosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}]",Pediatric pulmonology,['10.1002/ppul.24724']
262,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
263,31292457,Hepatic triglyceride content does not affect circulating CETP: lessons from a liraglutide intervention trial and a population-based cohort.,"Cholesteryl ester transfer protein (CETP) is mainly expressed by Kupffer cells in the liver. A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP. Since GLP-1 analogues also reduce HTGC, we assessed whether liraglutide decreases CETP. Furthermore, we investigated the association between HTGC and CETP in a population-based cohort. In a placebo-controlled trial, 50 patients with type 2 diabetes were randomly assigned to treatment with liraglutide or placebo added to standard care. In this trial and in 1,611 participants of the Netherlands Epidemiology of Obesity (NEO) study, we measured HTGC and circulating CETP by proton magnetic resonance spectroscopy and ELISA, respectively. The HTGC was decreased in the liraglutide group (-6.3%; 95%CI of difference [-9.5, -3.0]) but also in the placebo group (-4.0%; 95%CI[-6.0, -2.0]), without between-group differences. CETP was not decreased by liraglutide (-0.05 µg/mL; 95%CI[-0.13, 0.04]) or placebo (-0.04 µg/mL; 95%CI[-0.12, 0.04]). No association was present between HTGC and CETP at baseline (β: 0.002 µg/mL per %TG, 95%CI[-0.005, 0.009]) and between the changes after treatment with liraglutide (β: 0.003 µg/mL per %TG, 95%CI[-0.010, 0.017]) or placebo (β: 0.006 µg/mL per %TG, 95%CI[-0.012,0.024]). Also, in the cohort n o association between HTGC and CETP was present (β: -0.001 µg/mL per SD TG, 95%CI[-0.005, 0.003]). A reduction of HTGC after treatment with liraglutide or placebo does not decrease circulating CETP. Also, no association between HTGC and CETP was present in a large cohort. These findings indicate that circulating CETP is not determined by HTGC.Clinical Trial Registration: Clinicaltrials.gov (NCT01761318).",2019,A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP.,"['1,611 participants of the Netherlands Epidemiology of Obesity (NEO', '50 patients with type 2 diabetes']","['Cholesteryl ester transfer protein (CETP', 'liraglutide or placebo', 'HTGC and CETP', 'liraglutide', 'placebo', 'pioglitazone', 'HTGC', 'liraglutide or placebo added to standard care']","['hepatic triglyceride content (HTGC', 'circulating CETP', 'HTGC', 'Hepatic triglyceride content', 'CETP']","[{'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",1611.0,0.455577,A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP.,"[{'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands. H.J.van_Eyk@lumc.nl.'}, {'ForeName': 'Lisanne L', 'Initials': 'LL', 'LastName': 'Blauw', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'de Mutsert', 'Affiliation': 'Department Epidemiology, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department Radiology, LUMC, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-45593-2']
264,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
265,31296884,Quantification of the flux of tyrosine pathway metabolites during nitisinone treatment of Alkaptonuria.,"Nitisinone decreases homogentisic acid (HGA) in Alkaptonuria (AKU) by inhibiting the tyrosine metabolic pathway in humans. The effect of different daily doses of nitisinone on circulating and 24 h urinary excretion of phenylalanine (PA), tyrosine (TYR), hydroxyphenylpyruvate (HPPA), hydroxyphenyllactate (HPLA) and HGA in patients with AKU was studied over a four week period. Forty AKU patients, randomised into five groups of eight patients, received doses of 1, 2, 4 or 8 mg of nitisinone daily, or no drug (control). Metabolites were analysed by tandem mass spectrometry in 24 h urine and serum samples collected before and after nitisinone. Serum metabolites were corrected for total body water and the sum of 24 hr urine plus total body water metabolites of PA, TYR, HPPA, HPLA and HGA were determined. Body weight and urine urea were used to check on stability of diet and metabolism over the 4 weeks of study. The sum of quantities of urine metabolites (PA, TYR, HPPA, HPLA and HGA) were similar pre- and post-nitisinone. The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses. Similarly, combined 24 hr urine:total body water ratios for all analytes were significantly higher post-nitisinone, compared with pre-nitisinone baseline for all doses (p = 0.0002 - p < 0.0001). Significantly higher concentrations of metabolites from the tyrosine metabolic pathway were observed in a dose dependant manner following treatment with nitisinone and we speculate that, for the first time, experimental evidence of the metabolite pool that would otherwise be directed towards pigment formation, has been unmasked.",2019,The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses.,"['patients with AKU', 'Forty AKU patients']","['nitisinone daily, or no drug (control', 'nitisinone']","['total body water metabolites', 'urine:total body water ratios', 'quantities of urine metabolites (PA, TYR, HPPA, HPLA and HGA', 'Serum metabolites', 'Body weight and urine urea', 'circulating and 24\u2009h urinary excretion of phenylalanine (PA), tyrosine (TYR), hydroxyphenylpyruvate (HPPA), hydroxyphenyllactate (HPLA) and HGA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0173083', 'cui_str': 'nitisinone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0042037'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0147288', 'cui_str': 'Tyr(TMA)'}, {'cui': 'C0048391', 'cui_str': 'para-hydroxyphenyllactic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]",,0.0305042,The sum of total body water metabolites were significantly higher post-nitisinone (p < 0.0001) at all doses.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK. anna.milan@rlbuht.nhs.uk.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Hughes', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Davison', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rovensky', 'Affiliation': 'National Institute of Rheumatic Diseases, Piestany, Slovakia.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Block C, Waterhouse Building, Liverpool, L69 3GL, UK.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Cox', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Block C, Waterhouse Building, Liverpool, L69 3GL, UK.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Rhodes', 'Affiliation': 'Department of Musculoskeletal Biology, University of Liverpool, L7 8TX, Liverpool, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Gallagher', 'Affiliation': 'Department of Musculoskeletal Biology, University of Liverpool, L7 8TX, Liverpool, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Ranganath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool Clinical Laboratories, Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XP, UK.'}]",Scientific reports,['10.1038/s41598-019-46033-x']
266,32179153,"Preemptive analgesia with a single low dose of intrathecal morphine in multilevel posterior lumbar interbody fusion surgery: a double-blind, randomized, controlled trial.","BACKGROUND CONTEXT


Patients undergoing lumbar spinal surgery may experience considerable pain in the early postoperative period, and poor pain control after multilevel lumbar spinal fusion surgery is frequently associated with multiple complications and delayed discharge from hospital.
PURPOSE


The current study evaluated the efficacy and safety of preemptive analgesia with intrathecal morphine (ITM) in patients undergoing multilevel posterior lumbar spinal fusion surgery.
STUDY DESIGN


Double-blinded, randomized, controlled trial.
PATIENT SAMPLE


Ninety-two patients aged between 18 and 80 years who were scheduled to undergo elective lumbar laminectomy (L3-S1) and dual-level fusions.
OUTCOME MEASURES


The primary endpoint was the degree of postoperative pain at rest and during movement evaluated using a 10-point visual analogue scale. The secondary outcomes included the consumption of analgesics, the patient-assessed postoperative and satisfaction scores, adverse effects, time to first ambulation, and length of hospital stay.
METHODS


Patients were randomly allocated to either the ITM group that received 0.2 mg of ITM or the control (CON) group that received 2 ml of 0.9% saline as a skin infiltration 30 minutes prior to anesthesia induction.
RESULTS


The ITM group had a significantly lower visual analogue scale score than the CON group during the first 3 days postoperatively (at rest, P=0.000, during movement, P=0.000). The ITM group used significantly less sufentanil than the CON group in the first 3 days postoperatively (p=.000) in patient-controlled intravenous analgesia, as well as in supplemental analgesic demands. The ITM group reported a greater degree of satisfaction with the whole hospitalization experience than the CON group (2.4±0.6 vs. 1.9±0.6, p=.000). The two groups did not significantly differ regarding adverse effects, length of hospital stay, and time taken to regain the ability to walk without support.
CONCLUSIONS


Preemptive analgesia with ITM results in significantly improved early postoperative pain control and decreased postoperative patient-controlled intravenous analgesia consumption, with no increase in adverse effects.",2020,"The two groups did not significantly differ regarding adverse effects, length of hospital stay, and time taken to regain the ability to walk without support.
","['Patients undergoing lumbar spinal surgery', 'Multilevel Posterior Lumbar Interbody Fusion Surgery', 'Ninety-two patients aged between 18 and 80 years who were scheduled to undergo elective lumbar laminectomy (L3-S1) and dual-level fusions', 'Patients', 'patients undergoing multilevel posterior lumbar spinal fusion surgery']","['ITM or the control (CON) group that received 2 ml of 0.9% saline as a skin infiltration 30 minutes prior to anesthesia induction', 'CON', 'Intrathecal Morphine', 'ITM', 'sufentanil', 'preemptive analgesia with intrathecal morphine (ITM']","['visual analogue scale score', 'adverse effects, length of hospital stay, and time taken to regain the ability to walk without support', 'degree of postoperative pain at rest and during movement evaluated using a 10-point visual analogue scale', 'efficacy and safety', 'early postoperative pain control', 'adverse effects', 'consumption of analgesics, the patient-assessed postoperative and satisfaction scores, adverse effects, time to first ambulation, and length of hospital stay', 'degree of satisfaction with the whole hospitalization experience', 'postoperative patient-controlled intravenous analgesia consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion (procedure)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0241076', 'cui_str': 'Skin infiltration (procedure)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",92.0,0.150372,"The two groups did not significantly differ regarding adverse effects, length of hospital stay, and time taken to regain the ability to walk without support.
","[{'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China. Electronic address: gzq6698@sina.com.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China. Electronic address: anae@163.com.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.03.001']
267,32282691,Infraorbital Foramen Decompression Surgery for the Infraorbital Nerve Hypoesthesia in Patients With Isolated Fracture of Maxillary Sinus Anterior Wall.,"Isolated fracture of maxillary sinus anterior wall is relatively uncommon. If the extent of fracture is minimal, only conservative care is amenable, however, there is no agreement on whether infraorbital nerve dysfunction can be used as an indication for surgical intervention. This study was conducted to verify the effect of decompression surgery of infraorbital foramen for recovery of hypoesthesia. A total of 26 patients with unilateral fracture of maxillary sinus anterior wall were enrolled. Ten who received only conservative therapy were allocated in the control group, while sixteen patients were assigned to the decompression group. Pre- and post-treatment sensory assessment using visual analogue scale (VAS) was recorded. Overall treatment satisfaction was also evaluated by means of global assessment scale (GAS). Both absolute VAS value and score increment showed statistical difference only at 4 weeks (P = 0.010 and P = 0.021, respectively), but no significant difference at 1, 12, and 24 weeks. GAS score also showed no statistical significance (P = 0.386). Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall. Therefore, it is not recommended to perform the operation when the infraorbital nerve hypoesthesia is the only indication for the open reduction.",2020,Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall.,"['Patients With Isolated Fracture of Maxillary Sinus Anterior Wall', '26 patients with unilateral fracture of maxillary sinus anterior wall were enrolled']","['conservative therapy', 'Infraorbital Foramen Decompression Surgery', 'decompression surgery of infraorbital foramen']","['global assessment scale (GAS', 'hypoesthesia recovery', 'GAS score', 'Overall treatment satisfaction', 'visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0929085', 'cui_str': 'Infraorbital foramen'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",26.0,0.014145,Decompression surgery of infraorbital foramen does not have a significant effect on hypoesthesia recovery in isolated fracture of maxillary sinus anterior wall.,"[{'ForeName': 'Jongweon', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.""}, {'ForeName': 'Ee Room', 'Initials': 'ER', 'LastName': 'Jung', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu.""}, {'ForeName': 'Jin Tae', 'Initials': 'JT', 'LastName': 'Cho', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu.""}, {'ForeName': 'Gyeol', 'Initials': 'G', 'LastName': 'Yoo', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006455']
268,32250707,Improving Notifiable Disease Case Reporting Through Electronic Information Exchange-Facilitated Decision Support: A Controlled Before-and-After Trial.,"OBJECTIVE


Outbreak detection and disease control may be improved by simplified, semi-automated reporting of notifiable diseases to public health authorities. The objective of this study was to determine the effect of an electronic, prepopulated notifiable disease report form on case reporting rates by ambulatory care clinics to public health authorities.
METHODS


We conducted a 2-year (2012-2014) controlled before-and-after trial of a health information exchange (HIE) intervention in Indiana designed to prepopulate notifiable disease reporting forms to providers. We analyzed data collected from electronic prepopulated reports and ""usual care"" (paper, fax) reports submitted to a local health department for 7 conditions by using a difference-in-differences model. Primary outcomes were changes in reporting rates, completeness, and timeliness between intervention and control clinics.
RESULTS


Provider reporting rates for chlamydia and gonorrhea in intervention clinics increased significantly from 56.9% and 55.6%, respectively, during the baseline period (2012) to 66.4% and 58.3%, respectively, during the intervention period (2013-2014); they decreased from 28.8% and 27.5%, respectively, to 21.7% and 20.6%, respectively, in control clinics ( P  < .001). Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P  < .001), although mean completeness improved for 11 fields in both intervention and control clinics. Timeliness improved for both intervention and control clinics; however, reports from control clinics were timelier (mean, 7.9 days) than reports from intervention clinics (mean, 9.7 days).
CONCLUSIONS


Electronic, prepopulated case reporting forms integrated into providers' workflow, enabled by an HIE network, can be effective in increasing notifiable disease reporting rates and completeness of information. However, it was difficult to assess the effect of using the forms for diseases with low prevalence (eg, salmonellosis, histoplasmosis).",2020,"Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P  < .001), although mean completeness improved for 11 fields in both intervention and control clinics.",['Indiana designed to prepopulate notifiable disease reporting forms to providers'],"['health information exchange (HIE) intervention', 'Electronic Information Exchange-Facilitated Decision Support']","['mean completeness', 'changes in reporting rates, completeness, and timeliness between intervention and control clinics', 'chlamydia and gonorrhea in intervention clinics']","[{'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C3849995', 'cui_str': 'Medical Information Exchange'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}]",,0.0402737,"Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P  < .001), although mean completeness improved for 11 fields in both intervention and control clinics.","[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': '10668 Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Zuoyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '50826 Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, USA.'}, {'ForeName': 'Janet N', 'Initials': 'JN', 'LastName': 'Arno', 'Affiliation': '12250 School of Medicine, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Revere', 'Affiliation': '7284 School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joseph Gibson', 'Affiliation': '4059 Marion County Public Health Department, Indianapolis, IN, USA.'}, {'ForeName': 'Shaun J', 'Initials': 'SJ', 'LastName': 'Grannis', 'Affiliation': '50826 Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920914318']
269,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6']
270,31825192,Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer.,"BACKGROUND


Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. In a phase 1 dose-finding study, a majority of the patients with advanced HER2-positive breast cancer had a response to trastuzumab deruxtecan (median response duration, 20.7 months). The efficacy of trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab emtansine requires confirmation.
METHODS


In this two-part, open-label, single-group, multicenter, phase 2 study, we evaluated trastuzumab deruxtecan in adults with pathologically documented HER2-positive metastatic breast cancer who had received previous treatment with trastuzumab emtansine. In the first part of the study, we evaluated three different doses of trastuzumab deruxtecan to establish a recommended dose; in the second part, we evaluated the efficacy and safety of the recommended dose. The primary end point was the objective response, according to independent central review. Key secondary end points were the disease-control rate, clinical-benefit rate, duration of response and progression-free survival, and safety.
RESULTS


Overall, 184 patients who had undergone a median of six previous treatments received the recommended dose of trastuzumab deruxtecan (5.4 mg per kilogram of body weight). In the intention-to-treat analysis, a response to therapy was reported in 112 patients (60.9%; 95% confidence interval [CI], 53.4 to 68.0). The median duration of follow-up was 11.1 months (range, 0.7 to 19.9). The median response duration was 14.8 months (95% CI, 13.8 to 16.9), and the median duration of progression-free survival was 16.4 months (95% CI, 12.7 to not reached). During the study, the most common adverse events of grade 3 or higher were a decreased neutrophil count (in 20.7% of the patients), anemia (in 8.7%), and nausea (in 7.6%). On independent adjudication, the trial drug was associated with interstitial lung disease in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%).
CONCLUSIONS


Trastuzumab deruxtecan showed durable antitumor activity in a pretreated patient population with HER2-positive metastatic breast cancer. In addition to nausea and myelosuppression, interstitial lung disease was observed in a subgroup of patients and requires attention to pulmonary symptoms and careful monitoring. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.).",2020,"On independent adjudication, the trial drug was associated with interstitial lung disease in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%).
","['Previously Treated HER2-Positive Breast Cancer', 'patients with HER2-positive metastatic breast cancer previously treated with trastuzumab emtansine requires confirmation', 'patients with advanced HER2-positive breast cancer', '184 patients who had undergone a median of six previous treatments', 'adults with pathologically documented HER2-positive metastatic breast cancer who had received previous treatment with trastuzumab emtansine', 'pretreated patient population with HER2-positive metastatic breast cancer']","['Trastuzumab deruxtecan', 'trastuzumab deruxtecan', 'Trastuzumab Deruxtecan']","['objective response', 'efficacy and safety', 'median response duration', 'neutrophil count', 'interstitial lung disease', 'disease-control rate, clinical-benefit rate, duration of response and progression-free survival, and safety', 'durable antitumor activity', 'anemia', 'nausea', 'median duration of progression-free survival', 'nausea and myelosuppression, interstitial lung disease', 'median duration of follow']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",184.0,0.0414983,"On independent adjudication, the trial drug was associated with interstitial lung disease in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%).
","[{'ForeName': 'Shanu', 'Initials': 'S', 'LastName': 'Modi', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Denduluri', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Perrin', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Aogi', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Tokunaga', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Shuquan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shahidi', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Yver', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': ""From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center Hospital, Nagoya (H.I.), Kindai University Faculty of Medicine, Osaka (J.T.), Shikoku Cancer Center, Matsuyama (K.A.), and the National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - all in Japan; Samsung Medical Center (Y.H.P.), Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Yonsei Cancer Center, Yonsei University Health System (J. Sohn), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), Seoul, and the National Cancer Center, Gyeonggi (K.S.L.) - all in South Korea; Institut Gustave Roussy, Université Paris-Sud, Villejuif (F.A.), and Centre Eugène Marquis, Rennes (C.P.) - both in France; the US Oncology Network, Virginia Cancer Specialists, Arlington (N.D.); the University of California, Los Angeles-Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); Daiichi Sankyo, Basking Ridge, NJ (C.L., S.C., L.Z., J. Shahidi, A.Y.); and the Dana-Farber Cancer Institute, Boston (I.K.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1914510']
271,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
272,31385047,No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"OBJECTIVE


To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.
METHODS


Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.
RESULTS


A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3).
CONCLUSION


In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.
KEY POINTS


• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.",2020,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"['A total of 120 patients were included', 'Exclusion criteria were as follows: primary tumors existing more than 3\xa0months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50', 'percutaneous palliation of malignant hilar biliary obstruction', 'Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed']","['adjuvant chemotherapy', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents', 'endoscopic intervention']","['Median survival', 'Safety, clinical success, and adjuvant chemotherapy', 'Occlusion rate', 'occlusion rate, patency, and survival', 'clinical success', 'Serious adverse events', 'Median patency', '30-day mortality', 'safety, clinical success, adjuvant chemotherapy, patency, or survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",120.0,0.277257,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-019-06374-7']
273,32284380,"Safety, Pharmacokinetics, and Drug-Drug Interaction Potential of Intravenous Durlobactam, a β-Lactamase Inhibitor, in Healthy Subjects.","Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases. Addition of DUR to sulbactam (SUL)  in vitro  restores SUL activity against clinical isolates of  Acinetobacter baumannii  The safety and pharmacokinetics (PK) of DUR alone and with SUL and/or imipenem-cilastatin (IMI-CIL) were evaluated in healthy subjects. This was a randomized, placebo-controlled study. In part A, subjects, including a cohort of elderly subjects (which received DUR at 1 g), received single ascending doses of DUR ranging from 0.25 to 8 g. In part B, multiple ascending doses of DUR ranging from 0.25 to 2 g were administered every 6 h (q6h) for 29 doses. In parts C and D, the drug-drug interaction (DDI) potential, including the safety, of DUR (1 g) with SUL (1 g) and/or IMI-CIL (0.5/0.5 g) was investigated after single and multiple doses. Plasma and urine concentrations of DUR, SUL, and IMI-CIL were determined. Among 124 subjects, DUR was generally safe and well tolerated when it was administered either alone or in combination with SUL and/or IMI-CIL. After single and multiple doses, DUR demonstrated linear dose-proportional exposure across the studied dose ranges. Renal excretion was a predominant clearance mechanism. No drug-drug interaction potential between DUR and SUL and/or IMI-CIL was identified. SUL-DUR at 1 g (of each component) administered q6h with a 3-h intravenous (i.v.) infusion is under development for the treatment of serious infections due to  A. baumannii  (This study has been registered at ClinicalTrials.gov under identifier NCT02971423.).",2020,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","['124 subjects', 'Healthy Subjects', 'healthy subjects']","['SUL and/or imipenem/cilastatin (IMI/CIL', 'placebo', 'single ascending doses of DUR 0.25-8 g']","['safe and well tolerated', 'Renal excretion', 'Plasma and urine concentrations of DUR, SUL, and IMI/CIL']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1318217', 'cui_str': '8G'}]","[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0164683', 'cui_str': 'Cilest'}]",124.0,0.0285004,"Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': 'Tetraphase Pharmaceuticals, Watertown, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA John.odonnell@entasistx.com.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'Entasis Therapeutics, Inc., Waltham, Massachusetts, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00071-20']
274,32284384,"Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis).","Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants ( n  = 22) were confined to the clinic at baseline, received oral gepotidacin at 1,500 mg twice daily for 5 days (on-therapy period; days 1 to 5), and returned to the clinic for test-of-cure (days 10 to 13) and follow-up (day 28 ± 3) visits. Pharmacokinetic, safety, clinical, and microbiological assessments were performed. Maximum plasma concentrations were observed approximately 1.5 to 2 h postdose. Steady state was attained by day 3. Urinary exposure over the dosing interval increased from 3,742 μg·h/ml (day 1) to 5,973 μg·h/ml (day 4), with trough concentrations of 322 to 352 μg/ml from day 3 onward. Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends. Clinical success was achieved in 19 (86%) and 18 (82%) of 22 participants at test-of-cure and follow-up visits, respectively. Eight participants had a qualifying baseline uropathogen (growth; ≥10 5  CFU/ml). A therapeutic (combined clinical and microbiological [no growth; <10 3  CFU/ml]) successful response was achieved in 6 (75%) and 5 (63%) of 8 participants at test-of-cure and follow-up visits, respectively. Plasma area under the free-drug concentration-time curve over 24 h at steady state divided by the MIC ( f AUC 0-24 /MIC) and urine AUC 0-24 /MIC ranged from 6.99 to 90.5 and 1,292 to 121,698, respectively. Further evaluation of gepotidacin in uUTI is warranted. (This study has been registered in ClinicalTrials.gov under identifier NCT03568942.).",2020,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"['Eight participants had a qualifying baseline uropathogen (growth; ≥10 5  CFU/ml', 'Eligible participants (N = 22', 'female participants with uUTI', 'Female Participants With Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis']","['oral gepotidacin', 'Oral Gepotidacin (GSK2140944', 'urine AUC 0-24 /MIC']","['successful response', 'Pharmacokinetic, safety, clinical, and microbiological assessments', 'Maximum plasma concentrations', 'Plasma area under the free-drug concentration-time curve', 'Clinical success']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4309999', 'cui_str': 'gepotidacin'}, {'cui': 'C4310555', 'cui_str': 'GSK2140944'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",22.0,0.0764344,Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends.,"[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite, La Mesa, California, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Tiffany', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Scangarella-Oman', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Perry', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Barth', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Etienne F', 'Initials': 'EF', 'LastName': 'Dumont', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA Caroline.R.Perry@gsk.com Etienne.F.Dumont@gsk.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00199-20']
275,31285490,Association between Copy Number Variation and Response to Social Skills Training in Autism Spectrum Disorder.,"Challenges in social communication and interaction are core features of autism spectrum disorder (ASD) for which social skills group training (SSGT) is a commonly used intervention. SSGT has shown modest and heterogeneous effects. One of the major genetic risk factors in ASD is rare copy number variation (CNV). However, limited information exists whether CNV profiles could be used to aid intervention decisions. Here, we analyzed the rare genic CNV carrier status for 207 children, of which 105 received SSGT and 102 standard care as part of a randomized clinical trial for SSGT. We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS). However, when stratifying by pathogenicity and size of the CNVs, we identified that carriers of clinically significant and large genic CNVs (>500 kb) showed inferior SRS outcomes at post-intervention (P = 0.047 and P = 0.036, respectively) and follow-up (P = 0.008 and P = 0.072, respectively) when adjusting for standard care effects. Our study provides preliminary evidence that carriers of clinically significant and large genic CNVs might not benefit as much from SSGT as non-carriers. Our results indicate that genetic information might help guide the modifications of interventions in ASD.",2019,We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS).,"['207 children, of which 105 received SSGT and 102 standard care as part of a randomized clinical trial for SSGT', 'Autism Spectrum Disorder']","['SSGT', 'Social Skills Training']","['Social Responsiveness Scale (SRS', 'inferior SRS outcomes', 'large genic CNVs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4521834', 'cui_str': 'United States Military enlisted E6'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C4521834', 'cui_str': 'United States Military enlisted E6'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",207.0,0.041929,We found that being a carrier of rare genic CNV did not have an impact on the SSGT outcome measured by the parent-report Social Responsiveness Scale (SRS).,"[{'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tammimies', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden. kristiina.tammimies@ki.se.""}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Ielyzaveta', 'Initials': 'I', 'LastName': 'Rabkina', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Stamouli', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Becker', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Nicolaou', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Berggren', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Coco', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Falkmer', 'Affiliation': 'Curtin Autism Research Group, School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Bentley, Australia.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jonsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Choque-Olsson', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bölte', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Division of Neuropsychiatry, Centre for Psychiatry Research, Department of Women's and Children's Health, Karolinska Institutet, Solna, Sweden. sven.bolte@ki.se.""}]",Scientific reports,['10.1038/s41598-019-46396-1']
276,32278637,Editor's Choice - Role of Compression After Radiofrequency Ablation of Varicose Veins: A Randomised Controlled Trial ☆ .,"OBJECTIVE


Post-procedure limb compression, hitherto routine following open varicose vein surgery, has been extended to endovenous procedures. However, no robust evidence exists to support this practice. Most of the previous studies have focused on the ideal duration of compression. This study evaluates the clinical and patient reported outcomes with and without post-procedure leg compression following radiofrequency ablation (RFA).
METHODS


This single centre, prospective, non-inferiority randomised controlled trial recruited adult patients, into two groups (A: RFA with compression stocking for two weeks, B: RFA alone). The primary outcome was ultrasound determined target vein obliteration at 12 weeks. Secondary outcome measures included a Quality of Life (QoL) score [Aberdeen Varicose Vein Severity Score (AVSS) and Revised Venous Clinical Severity Score (RVCSS)], patient satisfaction, pain score, and complications.
RESULTS


In total, 100 consecutive patients were recruited (A: 51; B: 49) classified as clinical class C2-C6 of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification. At 12 weeks the occlusion rate of the target vein was similar in both groups at 98% (n = 47) and 98% (n = 45), respectively (p = 1.0). There was no statistically significant difference in mean AVSS 6 vs. 5.0 (mean difference -1, 95% CI -2 - 3, p = .57) and mean RVCSS 3 vs. 4 (mean difference 1, 95% CI -1 - 2, p = .46) scores at 12 weeks. Comparable patient satisfaction scores were observed (p = .72) and pain score 2.0 vs. 2.0 (p = .92) were achieved in both groups. Two patients in each group developed deep vein thrombosis at two weeks follow up (p = 1.0 for above the knee and p = 1.0 for below the knee).
CONCLUSION


The clinical and patient reported outcomes following RFA without compression are no worse than with compression. This trial supports the conclusion that the widely practised use of compression after RFA adds no clinical benefit for the patients. However, a much larger study, preferably a multicentre trial, may be required to confirm this conclusion.",2020,"At 12 weeks the occlusion rate of the target vein was similar in both groups at 98% (n = 47) and 98% (n = 45), respectively (p = 1.0).","['Varicose Veins', '100 consecutive patients were recruited (A: 51; B: 49) classified as clinical class C2-C6 of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification']","['Radiofrequency Ablation', 'Compression', 'radiofrequency ablation (RFA']","['deep vein thrombosis', 'ultrasound determined target vein obliteration', 'occlusion rate of the target vein', 'mean AVSS', 'Quality of Life (QoL) score [Aberdeen Varicose Vein Severity Score (AVSS) and Revised Venous Clinical Severity Score (RVCSS)], patient satisfaction, pain score, and complications', 'pain score', 'patient satisfaction scores']","[{'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",100.0,0.282396,"At 12 weeks the occlusion rate of the target vein was similar in both groups at 98% (n = 47) and 98% (n = 45), respectively (p = 1.0).","[{'ForeName': 'Madu', 'Initials': 'M', 'LastName': 'Onwudike', 'Affiliation': 'Vascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK; Vascular Surgery, Bolton Hospitals NHS Foundation Trust, Bolton, UK. Electronic address: madu@doctors.org.uk.'}, {'ForeName': 'Kazim', 'Initials': 'K', 'LastName': 'Abbas', 'Affiliation': 'Vascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'Vascular Surgery, Bolton Hospitals NHS Foundation Trust, Bolton, UK.'}, {'ForeName': 'Damien M', 'Initials': 'DM', 'LastName': 'McElvenny', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, University of Manchester, UK.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.03.014']
277,32181747,"Pilot Study of a Multilevel Mobile Health App for Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV Among Youth: Randomized Controlled Trial.","BACKGROUND


Preventing and reducing substance use disorders, sexually transmitted infections (STIs)/HIV, and teen pregnancy, and the associated risk behaviors (ie, substance use and sexual risk behaviors) among youth remain public health priorities in the United States. Equally important is improving the uptake of STI/HIV testing among the youth. Mobile health (mHealth) apps may be a solution to ameliorate these public health concerns; however, few mHealth preventive interventions have demonstrated efficacy in reducing substance use or sexual risk behaviors or improving the uptake of STI/HIV testing among the youth, particularly in clinic settings.
OBJECTIVE


This small-scale study aimed to examine the feasibility of conducting a pilot randomized controlled trial (RCT). We evaluated the effects of Storytelling 4 Empowerment (S4E), relative to enhanced usual practice, on the potential mechanisms by which behavior change occurs, namely clinician-youth risk communication, prevention knowledge, and substance use and sexual risk refusal self-efficacy. We also assessed the ability to measure targeted outcomes of past 30-day substance use (ie, alcohol, tobacco, and other drug use), condomless sex, and alcohol or drug use before sex, as well as the uptake of STI/HIV testing.
METHODS


Employing community-based participatory research principles, 50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan, randomized sequentially to either S4E or enhanced usual practice, and assessed at baseline, immediately postintervention, and 30 days postintervention. S4E consists of 3 modules, including alcohol and drug use, tobacco, and STI/HIV.
RESULTS


Relative to youth in the enhanced usual practice group, S4E participants demonstrated higher youth-clinician risk communication (mean 3.22, SD 1.67) and increases in prevention knowledge (∆ score mean 0.36, SD 0.51) and self-efficacy (∆ score mean 0.16, SD 0.47). In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84). The results also suggest a reduction in the proportion of youths who reported past 30-day condomless sex (Cohen h=0.18, 95% CI -0.38 to 0.74) and alcohol use before sex (Cohen h=0.44, 95% CI -0.12 to 1.00). Finally, the findings also demonstrated an increase in the proportion of youths who reported STI/HIV testing over time (Cohen h=0.16, 95% CI -0.39 to 0.72).
CONCLUSIONS


The findings suggest the feasibility of a small-scale pilot RCT. S4E demonstrated shifts in the hypothesized direction, reducing substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing among youth in a clinic setting. The findings suggest that a larger RCT may be warranted.
TRIAL REGISTRATION


ClinicalTrails.gov NCT03855410, https://clinicaltrials.gov/ct2/show/NCT03855410.",2020,"In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84).",['50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan'],"['Storytelling 4 Empowerment (S4E', 'S4E']","['proportions of past 30-day overall substance use', 'youth-clinician risk communication', 'self-efficacy', 'substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing', 'proportion of youths who reported STI/HIV testing over time', 'Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV', 'prevention knowledge', 'past 30-day alcohol']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562982', 'cui_str': 'Youth club (environment)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",50.0,0.112227,"In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cordova', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Munoz-Velazquez', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frania', 'Initials': 'F', 'LastName': 'Mendoza Lua', 'Affiliation': 'School of Social Service Administration, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fessler', 'Affiliation': 'Corner Health Center, Ypsilanti, MI, United States.'}, {'ForeName': 'Sydni', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Delva', 'Affiliation': 'School of Social Work, Boston University, Boston, MA, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Adelman', 'Affiliation': 'Corner Health Center, Ypsilanti, MI, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bauermeister', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16251']
278,31350585,Recovery and prognostic value of myocardial strain in ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion.,"OBJECTIVES


Global left ventricular (LV) function is routinely used to assess cardiac function; however, myocardial strain is able to identify more subtle dysfunction. We aimed to determine the recovery and prognostic value of featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain in ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO).
METHODS


In the randomized EXPLORE trial, there was no significant difference in global LV function after percutaneous coronary intervention (PCI) of the CTO, compared with no-CTO PCI, post-STEMI. In the current study, we included 200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR. Global longitudinal strain (GLS) was calculated from 3 long-axis views. Global circumferential strain (GCS) and segmental strain were calculated from 3 short-axis views (basal, mid, and apical).
RESULTS


Global strain significantly improved at 4 months (GLS ∆ - 1.8 ± 4.3%, p < 0.001; GCS ∆ - 1.7 ± 4.7%, p < 0.001); however, there was no treatment effect of CTO-PCI on strain recovery. GLS was a significant predictor for 4 months of LV ejection fraction (p = 0.006), incremental to other CMR parameters including infarct size. For mortality, infarct size remained the strongest predictor. On regional level, segmental strain independently predicted recovery in the dysfunctional segments (p < 0.001).
CONCLUSIONS


Global and segmental myocardial strains significantly improved over time, with no effect of CTO-PCI. Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory. Further research is needed to determine the additional prognostic value of strain beyond routine CMR parameters.
KEY POINTS


• In STEMI patients with a concurrent CTO, strain significantly improves over time, regardless of CTO-PCI. • Global strain is an independent predictor for functional recovery, incremental to infarct size, LVEF, and clinical parameters. • Segmental strain was able to predict the recovery of wall thickening, incremental to transmural extent of infarction.",2020,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"['ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion', '200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR', 'ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO']",['featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain'],"['Global strain', 'Global circumferential strain (GCS) and segmental strain', 'global LV function', 'Global longitudinal strain (GLS', 'LV ejection fraction']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",302.0,0.0840994,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"[{'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.elias@amsterdamumc.nl.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Loes P', 'Initials': 'LP', 'LastName': 'Hoebers', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Dagmar M', 'Initials': 'DM', 'LastName': 'Ouweneel', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': 'North Estonia Medical Center, Tallinn, Estonia.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ioanes', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'University Medical Center St Radboud, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06338-x']
279,32285617,Autologous platelet-rich plasma injection enhances healing of chronic venous leg ulcer: A prospective randomised study.,"Our aim was to compare the efficacy and safety of platelet-rich plasma (PRP) application versus PRP injection for chronic venous leg ulcer (VLU) healing compared with compression therapy as a control. From July 2018 to December 2019, 90 chronic VLU patients were randomly assigned to PRP dressings (n = 30), local PRP injections (n = 30), and compression therapy alone (n = 30). Standard compression accompanied both PRP groups. The main endpoints were ulcer healing and area reduction within 3, 6, and 12 months. Complications and ulcer recurrence were also recorded. The study included 72 (80.0%) males and 18 (20.0%) females aged 22 to 66 years, having VLUs for 1 to 11 years. PRP injection promoted healing (24/30, 80%) more than PRP application (20/30, 66.7%) and compression (14/30, 46.7%), P = .007. Healing time was significantly shorter after PRP injection compared with the other two groups. A greater area reduction was observed after PRP injection compared with compression at all follow-up visits, P = .013, .002, and < .001, and compared with PRP application only at 3 months post-treatment, P = .016. Recurrence and complications were comparable among the groups. PRP injection enhances the healing of chronic venous ulcers more than each of PRP application and compression therapy. All had comparable recurrence and safety.",2020,"A greater area reduction was observed after PRP injection compared with compression at all follow-up visits, P = .013, .002, and < .001, and compared with PRP application only at 3 months post-treatment, P = .016.","['chronic venous leg ulcer', 'The study included 72 (80.0%) males and 18 (20.0%) females aged 22 to 66\u2009years, having VLUs for 1 to 11\u2009years', 'From July 2018 to December 2019, 90 chronic VLU patients']","['platelet-rich plasma (PRP) application versus PRP injection', 'compression therapy', 'compression therapy alone', 'local PRP injections', 'Autologous platelet-rich plasma injection', 'PRP injection', 'PRP dressings']","['Healing time', 'area reduction', 'compression', 'recurrence and safety', 'ulcer healing and area reduction', 'PRP injection promoted healing', 'Complications and ulcer recurrence', 'Recurrence and complications', 'healing of chronic venous ulcers']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]",,0.0140036,"A greater area reduction was observed after PRP injection compared with compression at all follow-up visits, P = .013, .002, and < .001, and compared with PRP application only at 3 months post-treatment, P = .016.","[{'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Elbarbary', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Tanta University Hospitals, Tanta, Egypt.'}, {'ForeName': 'Hassan A', 'Initials': 'HA', 'LastName': 'Hassan', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Tanta University Hospitals, Tanta, Egypt.'}, {'ForeName': 'Elsayed A', 'Initials': 'EA', 'LastName': 'Elbendak', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Tanta University Hospitals, Tanta, Egypt.'}]",International wound journal,['10.1111/iwj.13361']
280,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
281,32044802,Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial.,"BACKGROUND


Interscalene brachial plexus block, the pain relief standard for shoulder surgery, is an invasive technique associated with important complications. The subomohyoid anterior suprascapular block is a potential alternative, but evidence of its comparative analgesic effect is sparse. The authors tested the hypothesis that anterior suprascapular block is noninferior to interscalene block for improving pain control after shoulder surgery. As a secondary objective, the authors evaluated the success of superior trunk (C5-C6 dermatomes) block with suprascapular block.
METHODS


In this multicenter double-blind noninferiority randomized trial, 140 patients undergoing shoulder surgery were randomized to either interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine. The primary outcome was area under the curve of postoperative visual analog scale pain scores during the first 24 h postoperatively. The 90% CI for the difference (interscalene-suprascapular) was compared against a -4.4-U noninferiority margin. Secondary outcomes included presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery.
RESULTS


A total of 136 patients were included in the analysis. The mean difference (90% CI) in area under the curve of pain scores for the (interscalene-suprascapular) comparison was -0.3 U (-0.8 to 0.12), exceeding the noninferiority margin of -4.4 U and demonstrating noninferiority of suprascapular block. The risk ratio (95% CI) of combined superior trunk (C5-C6 dermatomes) blockade was 0.98 (0.92 to 1.01), excluding any meaningful difference in superior trunk block success rates between the two groups. When differences in other analgesic outcomes existed, they were not clinically important.
CONCLUSIONS


The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk. These findings suggest that the suprascapular block consistently blocks the superior trunk and qualify it as an effective interscalene block alternative.",2020,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","['Arthroscopic Shoulder Surgery', '140 patients undergoing shoulder surgery', 'A total of 136 patients were included in the analysis']","['Subomohyoid Anterior Suprascapular Block versus Interscalene Block', 'interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine']","['superior trunk block success rates', 'presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery', 'area under the curve of postoperative visual analog scale pain scores', 'pain scores', 'risk ratio']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",140.0,0.219577,"The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk.","[{'ForeName': 'Faraj W', 'Initials': 'FW', 'LastName': 'Abdallah', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada (F.W.A.) the Department of Anesthesia (F.W.A., D.N.W., R.B., A.M., V.W.S.C.) the Institute of Health Policy, Management, and Evaluation (D.N.W., A.L.) the Department of Medicine (A.L.) the Dalla Lana School of Public Health (K.E.T.), University of Toronto, Toronto, Canada the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Canada (F.W.A., D.N.W., A.L.) the Department of Anesthesia (D.N.W.) the Department of Medicine (A.L.), St. Michael's Hospital, Toronto, Canada the Department of Anesthesia and Pain Management, University Health Network, Toronto, Canada (D.N.W., V.W.S.C.) the Department of Anesthesia, Women's College Hospital, Toronto, Canada (R.B.) the Department of Anesthesia, North York General Hospital, Toronto, Canada (A.M.) the Department of Anesthesia, Wexner Medical Center, Ohio State University, Columbus, Ohio (N.H.) the Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada (K.E.T.).""}, {'ForeName': 'Duminda N', 'Initials': 'DN', 'LastName': 'Wijeysundera', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brull', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Mocon', 'Affiliation': ''}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Hussain', 'Affiliation': ''}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ''}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Chan', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003132']
282,32084505,Screening and identification of salivary biomarkers for assessing the effects of exogenous testosterone administration on HPG and HPA axes and ECS.,"The contents of steroids and endocannabinoids along with the ratios between them would be candidate biomarkers for sensitively and comprehensively assessing the role of testosterone in regulating the activities of the hypothalamus-pituitary-gonadal (HPG) axis, the hypothalamus-pituitaryadrenal (HPA) axis and endogenous cannabinoid system (ECS). However, previous studies mostly used the contents rather than the ratios as biomarkers. This study aimed to systematically screen and identify sensitive biomarkers from 21 candidates including both the contents of nine steroids and one endocannabinoid and their ratios in saliva. Three screening criteria were whether there were intergroup differences, time-dependent changes and considerable relative stability during a 4-h period after exogenous testosterone administration. This study used LC-APCI + -MS/MS to determine the salivary levels of the candidate biomarkers on 62 male healthy undergraduates who were divided into testosterone administration and placebo control groups. The results revealed that salivary testosterone, androstenedione, DHEA and the ratios of testosterone to estradiol and AEA, and of cortisol to testosterone and DHEA were sensitive biomarkers for assessing the effects of testosterone administration on the three neuroendocrine systems because they all showed significant intergroup differences and time-dependent changes and good relative stability. Salivary cortisol, cortisone and the ratios of testosterone to androstenedione and DHEA and of androstenedione to estrone, and of cortisol to cortisone, androstenedione and AEA might be suitable biomarkers because they met only two of the three criteria, but needed to be validated in the future. The rest biomarkers were unsuitable because they mostly showed no significant intergroup differences, blunt time-dependent changes and poor relative stability.",2020,"Salivary cortisol, cortisone and the ratios of testosterone to androstenedione and DHEA and of androstenedione to estrone, and of cortisol to cortisone, androstenedione and AEA might be suitable biomarkers because they met only two of the three criteria, but needed to be validated in the future.","['62 male healthy undergraduates who were divided into', 'control groups', '21 candidates including both the contents of nine steroids and one endocannabinoid and their ratios in saliva']","['exogenous testosterone', 'testosterone administration and placebo', 'LC-APCI + -MS/MS']","['salivary testosterone, androstenedione, DHEA and the ratios of testosterone to estradiol and AEA, and of cortisol to testosterone and DHEA', 'HPG and HPA axes and ECS', 'blunt time-dependent changes and poor relative stability', 'Salivary cortisol, cortisone and the ratios of testosterone to androstenedione and DHEA and of androstenedione to estrone, and of cortisol to cortisone, androstenedione and AEA']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",62.0,0.0299193,"Salivary cortisol, cortisone and the ratios of testosterone to androstenedione and DHEA and of androstenedione to estrone, and of cortisol to cortisone, androstenedione and AEA might be suitable biomarkers because they met only two of the three criteria, but needed to be validated in the future.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Brain and Learning Science, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, China; Key Laboratory of Child Development and Learning Science (Southeast University), Ministry of Education, Nanjing 210096, China; Institute of Child Development and Education, Research Center for Learning Science, Southeast University, Nanjing 210096, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen 518061, China; School of Psychology, Shenzhen University, Shenzhen 518061, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'College of Food Science and Technology, Nanjing Agricultural University, Nanjing 210095, China.'}, {'ForeName': 'Liuxi', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Brain and Learning Science, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, China; Key Laboratory of Child Development and Learning Science (Southeast University), Ministry of Education, Nanjing 210096, China; Institute of Child Development and Education, Research Center for Learning Science, Southeast University, Nanjing 210096, China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Brain and Learning Science, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, China; Key Laboratory of Child Development and Learning Science (Southeast University), Ministry of Education, Nanjing 210096, China; Institute of Child Development and Education, Research Center for Learning Science, Southeast University, Nanjing 210096, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Brain and Learning Science, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, China; Key Laboratory of Child Development and Learning Science (Southeast University), Ministry of Education, Nanjing 210096, China; Institute of Child Development and Education, Research Center for Learning Science, Southeast University, Nanjing 210096, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen 518061, China; School of Psychology, Shenzhen University, Shenzhen 518061, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen 518061, China; School of Psychology, Shenzhen University, Shenzhen 518061, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Brain and Learning Science, School of Biological Science & Medical Engineering, Southeast University, Nanjing 210096, China; Key Laboratory of Child Development and Learning Science (Southeast University), Ministry of Education, Nanjing 210096, China; Institute of Child Development and Education, Research Center for Learning Science, Southeast University, Nanjing 210096, China. Electronic address: dengrcls@seu.edu.cn.'}]",Steroids,['10.1016/j.steroids.2020.108604']
283,28906348,Effect of Anodal Transcranial Direct Current Stimulation of the Motor Cortex on Elbow Flexor Muscle Strength in the Very Old.,"BACKGROUND AND PURPOSE


Muscle weakness predisposes older adults to a fourfold increase in functional limitations and has previously been associated with reduced motor cortex excitability in aging adults. The purpose of this study was to determine whether a single session of anodal transcranial direct current stimulation (tDCS) of the motor cortex would increase elbow flexion muscle strength and electromyographic (EMG) amplitude in very old individuals.
METHODS


Eleven very old individuals-85.8 (4.3) years-performed 3 maximal isometric elbow flexion contractions before and after 20 minutes of sham or anodal tDCS on different days. Order of stimulation was randomized, and the study participants and investigators were blinded to condition. In addition, voluntary activation capacity of the elbow flexors was determined by comparing voluntary and electrically evoked forces.
RESULTS


Anodal tDCS did not alter muscle strength or EMG activity in comparison to sham stimulation. Elbow flexion voluntary activation capacity was very high among the study participants: 99.3% (1.8%).
CONCLUSION


Contrary to our hypothesis, we observed no effect of anodal tDCS and no impairment in elbow flexor voluntary activation capacity in the very old. Whether anodal tDCS would exert a positive effect and support our initial hypothesis in another muscle group that does exhibit impairments in voluntary activation in older adults is a question that is still to be addressed.",2019,"Contrary to our hypothesis, we observed no effect of anodal tDCS and no impairment in elbow flexor voluntary activation capacity in the very old.","['the Very Old', 'Eleven very old individuals-85.8', 'very old individuals', 'older adults', 'Muscle weakness predisposes older adults']","['anodal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'Anodal Transcranial Direct Current Stimulation', 'sham or anodal tDCS']","['elbow flexion muscle strength and electromyographic (EMG) amplitude', 'elbow flexor voluntary activation capacity', 'voluntary activation capacity of the elbow flexors', 'Elbow flexion voluntary activation capacity', 'Elbow Flexor Muscle Strength', 'muscle strength or EMG activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0281205,"Contrary to our hypothesis, we observed no effect of anodal tDCS and no impairment in elbow flexor voluntary activation capacity in the very old.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Oki', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}, {'ForeName': 'Leatha A', 'Initials': 'LA', 'LastName': 'Clark', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Amano', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Clark', 'Affiliation': 'Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000145']
284,32277008,Effects of Weight Loss and Weight Regain on Circulating Biomarkers in Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest.,"BACKGROUND


Obesity is associated with worse breast cancer prognosis, however little is known about the level of weight loss required to improve pathway biomarkers. The effects of weight regain on biomarkers are also largely unknown.
METHODS


Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided weight and serum biomarkers [leptin, adiponectin, insulin, plasminogen activator inhibitor-1 (PAI-1), IL-6, TNFα, and hepatocyte growth factor HGF] at baseline, 6, and 18 months ( n  = 138). Change in biomarkers over time and by weight loss thresholds were examined.
RESULTS


Mean weight loss at 6 months was 13.3 ± 5.0 kg; from 6 to 18 months, mean regain was 4.0 ± 5.2 kg. Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF ( P  < 0.006 to  P  < 0.0001). These changes remained significant overall at 18 months despite attenuation in some. Women who lost <10% of baseline weight showed significantly smaller modulation effects for leptin ( P  < 0.0001), adiponectin:leptin (A/L) ratio ( P  < 0.0001), PAI-1 ( P  < 0.001), and insulin ( P  = 0.003) compared with women who lost >10%. Women who lost >10% observed a significant increase in adiponectin ( P  < 0.0001), and these women continued to show improved adiponectin from 6 to 18 months despite weight regain. Physical activity contributed additional effects on biomarker change for leptin, A/L ratio, and PAI-1.
CONCLUSIONS


These findings are consistent with a clinical target of 10% weight.
IMPACT


Sustained increases in adiponectin likely confer benefits for breast cancer prognosis even with weight regain.",2020,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","['Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest', 'Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided']",['Weight Loss and Weight Regain'],"['Favorable biomarker modulations', 'smaller modulation effects for leptin (p<0.0001), adiponectin:leptin (A/L) ratio (p<0.0001), PAI-1', 'biomarker change for leptin, A/L ratio, and PAI-1', 'leptin, adiponectin, insulin, PAI-1, IL-6, and HGF', 'PAI-1], interleukin-6 [IL-6], tumor necrosis factor alpha [TNFα], and hepatocyte growth factor [HGF', 'Mean weight loss', 'adiponectin', 'weight and serum biomarkers (leptin, adiponectin, insulin, plasminogen activator inhibitor-1']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",138.0,0.0228327,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","[{'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas. cbefort@kumc.edu.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Leonidas E', 'Initials': 'LE', 'LastName': 'Bantis', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1572']
285,32073956,Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial.,"PURPOSE


A phase II study (ClinicalTrials.gov identifier: NCT00628251) showed activity of olaparib capsules versus pegylated liposomal doxorubicin in patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer. We conducted a phase III trial (SOLO3) of olaparib tablets versus nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.
PATIENTS AND METHODS


In this randomized, open-label trial, patients were randomly assigned 2:1 to olaparib 300 mg twice a day or physician's choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan). The primary end point was objective response rate (ORR) in the measurable disease analysis set assessed by blinded independent central review (BICR). The key secondary end point was progression-free survival (PFS) assessed by BICR in the intent-to-treat population.
RESULTS


Of 266 randomly assigned patients, 178 were assigned to olaparib and 88 to chemotherapy. In patients with measurable disease (olaparib, n = 151; chemotherapy, n = 72), the BICR-assessed ORR was significantly higher with olaparib than with chemotherapy (72.2%  v  51.4%; odds ratio [OR], 2.53 [95% CI, 1.40 to 4.58];  P  = .002). In the subgroup who had received 2 prior lines of treatment, the ORR was 84.6% with olaparib and 61.5% with chemotherapy (OR, 3.44 [95% CI, 1.42 to 8.54]). BICR-assessed PFS also significantly favored olaparib versus chemotherapy (hazard ratio, 0.62 [95% CI, 0.43 to 0.91];  P  = .013; median, 13.4  v  9.2 months). Adverse events were consistent with the established safety profiles of olaparib and chemotherapy.
CONCLUSION


Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.",2020,Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.,"['266 randomly assigned patients', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of', 'patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer', 'Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3']","['platinum-based chemotherapy', 'Olaparib Versus Nonplatinum Chemotherapy', 'olaparib tablets versus nonplatinum chemotherapy', 'olaparib capsules versus pegylated liposomal doxorubicin', 'nonplatinum chemotherapy', ""olaparib 300 mg twice a day or physician's choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan""]","['BICR-assessed ORR', 'ORR', 'progression-free survival (PFS) assessed by BICR', 'central review (BICR', 'BICR-assessed PFS', 'ORR and PFS', 'Adverse events', 'objective response rate (ORR']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.196593,Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.,"[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ricardo Villalobos', 'Initials': 'RV', 'LastName': 'Valencia', 'Affiliation': 'Centro Medico Dalinde, Mexico City, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'First Faculty of Medicine, Charles University and General University, Prague, Czech Republic.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'University of Milan-Bicocca and IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Leath', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Bidziński', 'Affiliation': 'Faculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, Poland.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Nam', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Madry', 'Affiliation': 'Medical University K. Marcinkowski and Clinical Hospital of the Transfiguration, Poznań, Poland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernández', 'Affiliation': 'Oaxaca Site Management Organization, Oaxaca de Juarez, Mexico.'}, {'ForeName': 'Paulo A R', 'Initials': 'PAR', 'LastName': 'Mora', 'Affiliation': 'Instituto COI de Educação e Pesquisa, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sang Young', 'Initials': 'SY', 'LastName': 'Ryu', 'Affiliation': 'Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.'}, {'ForeName': 'Tsveta', 'Initials': 'T', 'LastName': 'Milenkova', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Lowe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Università Cattolica del Sacro Cuore-Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02745']
286,31851799,Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.,"BACKGROUND


Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a  BRCA  mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of  BRCA  mutation status is unknown.
METHODS


We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or  BRCA  mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death.
RESULTS


Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had  BRCA  mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have  BRCA  mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.
CONCLUSIONS


In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a  BRCA  mutation. (Funded by ARCAGY Research and others; PAOLA-1 ClinicalTrials.gov number, NCT02477644.).",2019,"The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had  BRCA  mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have  BRCA  mutations (median progression-free survival, 28.1 vs. 16.6 months).","['women with newly diagnosed advanced ovarian cancer with a  BRCA  mutation', 'Ovarian Cancer', 'patients with advanced ovarian cancer receiving first-line standard therapy including', 'patients regardless of  BRCA  mutation status', 'Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum', 'Patients were eligible regardless of surgical outcome or  BRCA  mutation status', '806 patients who underwent randomization']","['taxane chemotherapy plus bevacizumab', 'bevacizumab', 'maintenance olaparib and bevacizumab', 'Olaparib plus Bevacizumab', 'olaparib', 'placebo', 'placebo plus bevacizumab', 'olaparib tablets']","['Adverse events', 'median progression-free survival', 'time from randomization until investigator-assessed disease progression or death', 'disease progression or death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",537.0,0.661422,"The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had  BRCA  mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have  BRCA  mutations (median progression-free survival, 28.1 vs. 16.6 months).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mäenpää', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Guerra Alía', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Nagao', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Combe', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Buderath', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Dubot', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Burges', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': ""From Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) - all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan-Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) - all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universitario Ramón y Cajal (E.M.G.A.) - all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)-Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) - all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) - all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) - both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) - all in Germany.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911361']
287,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
288,32282472,Endoscopic Endonasal Dacryocystorhinostomy With a Novel Lacrimal Ostium Stent in Chronic Dacryocystitis Cases With Small Lacrimal Sac.,"PURPOSE


To investigate feasibility of endoscopic endonasal dacryocystorhinostomy (EE-DCR) with an novel lacrimal ostium stent (LOS) intubation for patients with chronic dacryocystitis with small lacrimal sac.
METHODS


Patients diagnosed as chronic dacryocystitis with small lacrimal sac who preferred to surgery treatment between March 1st, 2012 and May 1st, 2015. All included subjects were randomly divided into 2 groups (Group A and Group B). Cases in group A were performed EE-DCR with LOS intubation while cases in group B were underwent EE-DCR without LOS intubation. Demographic data of each cases were collected. The success rate and the surgical outcomes of 2 groups were compared.
RESULTS


The success rate was much higher in group A than group B. At 3 months follow up, 61.6% of patients in group A exhibited scarring and/or granulation tissues around the ostium, which was significantly higher than the 36.4% of patients in group B. Of these patients with scars and/or granulation tissues, no statistical difference was found between 2 groups. Granuloma alone and scars with granuloma were observed in 10 patients and 2 patients, in group A and group B, respectively, resulting in a statistical significant difference for this outcome between the groups. At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
CONCLUSIONS


EE-DCR with novel LOS may be an effective procedure to manage chronic dacryocystitis with small lacrimal sac.",2020,"At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
","['Patients diagnosed as chronic dacryocystitis with small lacrimal sac who preferred to surgery treatment between March 1st, 2012 and May 1st, 2015', 'Chronic Dacryocystitis Cases With Small Lacrimal Sac', 'patients with chronic dacryocystitis with small lacrimal sac']","['EE-DCR without LOS intubation', 'Endoscopic Endonasal Dacryocystorhinostomy With a Novel Lacrimal Ostium Stent', 'novel lacrimal ostium stent (LOS) intubation', 'endoscopic endonasal dacryocystorhinostomy (EE-DCR']","['Granuloma alone and scars with granuloma', 'scarring and/or granulation tissues', 'success rate', 'rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma', 'success rate and the surgical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149506', 'cui_str': 'Chronic dacryocystitis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0229289', 'cui_str': 'Lacrimal sac structure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0018188', 'cui_str': 'Granuloma'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.023086,"At 9 months follow up and 12 months follow up, no significant statistical difference were found in the rate of scarring and/or granulation tissues, scars alone, granuloma alone and scars with granuloma between 2 groups.
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Zhenbin', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Eye Hospital at Hangzhou, Wenzhou Medical University, Hangzhou, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Orbital & Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006359']
289,28438476,Fulfilling the psychological and information need of the family members of critically ill patients using interactive mobile technology: A randomised controlled trial.,"BACKGROUND


Intensive care nurses may have an important role in empowering families by providing psychological support and fulfilling the family's pivotal need for information.
AIM


To determine whether 'education of families by tab' about the patient's condition was more associated with improved anxiety, stress, and depression levels than the 'education of families by routine'.
RESEARCH DESIGN


A randomized control trial of 74 main family caregivers (intervention: 39; control: 35).
SETTING


An adult intensive care unit.
MAIN OUTCOME MEASURES


Depression Anxiety Stress Scale, and Communication and Physical Comfort Scale.
RESULTS


Although information need satisfaction was not significantly different between intervention and control groups, the former reported significantly better depression score on Depression Anxiety Stress Scale comparing to the control group (p<0.01; η 2 =0.09) with a medium effect size. Reduction of anxiety in the intervention group were clinically significant.
CONCLUSION


The results suggest that use of 'education of family by tab' is promising for intensive care nurses to provide psychological support for family members. More studies are needed to investigate this aspect of family care for better psychological support and information need satisfaction that contributes to the evidence-based practice of intensive care nursing.",2017,"Although information need satisfaction was not significantly different between intervention and control groups, the former reported significantly better depression score on Depression Anxiety Stress Scale comparing to the control group (p<0.01; η 2 =0.09) with a medium effect size.","['An adult intensive care unit', '74 main family caregivers (intervention: 39; control: 35']",['interactive mobile technology'],"['depression score on Depression Anxiety Stress Scale', 'Reduction of anxiety', 'Depression Anxiety Stress Scale, and Communication and Physical Comfort Scale', 'anxiety, stress, and depression levels']","[{'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",74.0,0.0616218,"Although information need satisfaction was not significantly different between intervention and control groups, the former reported significantly better depression score on Depression Anxiety Stress Scale comparing to the control group (p<0.01; η 2 =0.09) with a medium effect size.","[{'ForeName': 'Vico Chung Lim', 'Initials': 'VCL', 'LastName': 'Chiang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: vico.chiang@polyu.edu.hk.'}, {'ForeName': 'Rainbow Lai Ping', 'Initials': 'RLP', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: rainbow.l.p.lee@polyu.edu.hk.'}, {'ForeName': 'Mei Fung', 'Initials': 'MF', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hmf430@ha.org.hk.'}, {'ForeName': 'Chi Kwong', 'Initials': 'CK', 'LastName': 'Leung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: lck504@ha.org.hk.'}, {'ForeName': 'Pui Yi', 'Initials': 'PY', 'LastName': 'Tang', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: tpy336@ha.org.hk.'}, {'ForeName': 'Sze Wing', 'Initials': 'SW', 'LastName': 'Wong', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: wsw449@ha.org.hk.'}, {'ForeName': 'Sin Yee', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hsy446@ha.org.hk.'}, {'ForeName': 'Wai Yan', 'Initials': 'WY', 'LastName': 'Tung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: twy688a@ha.org.hk.'}, {'ForeName': 'Lai Hang', 'Initials': 'LH', 'LastName': 'Louie', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: LLH389@ha.org.hk.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2017.03.006']
290,31484629,"Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial.","BACKGROUND


Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor.
METHODS


The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population).
FINDINGS


Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8-3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74-0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction =0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78-1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75-1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48-2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36-3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74-1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75-0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction =0·012. Benefit was present irrespective of time from most recent PCI.
INTERPRETATION


In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk.
FUNDING


AstraZeneca.",2019,"The same effect was not observed in patients without PCI (p=0·76, p interaction =0·16).","['diabEtes Mellitus patients Intervention Study (THEMIS', 'Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery', 'patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk', '5536 patients with', 'controlled trial, done in 1315 sites in 42 countries', 'patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI', 'patients with diabetes, stable coronary artery disease', 'Patients with stable coronary artery disease and diabetes with previous', '5536 patients receiving', 'Between Feb 17, 2014, and May 24, 2016, 11\u2008154 patients (58% of the overall THEMIS trial) with a history of previous PCI', 'Eligible patients']","['percutaneous coronary intervention (PCI', 'Ticagrelor', 'aspirin plus ticagrelor', 'ticagrelor or placebo, by use of an interactive voice-response or web-response system', 'placebo', 'aspirin', 'ticagrelor']","['cardiovascular death, myocardial infarction, and stroke', 'fatal bleeding', 'Intracranial haemorrhage', 'proportion of patients with cardiovascular death', 'TIMI major bleeding', 'Health Outcomes', 'composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population']","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5536.0,0.373806,"The same effect was not observed in patients without PCI (p=0·76, p interaction =0·16).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA, USA. Electronic address: dlbhattmd@post.harvard.edu.""}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale U-1148, Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada; McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, Sorbonne-Université, Paris, France.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Mölndal, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Mölndal, Sweden.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Ridderstråle', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Mölndal, Sweden.'}, {'ForeName': 'Jersey', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, MD, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Baim Institute for Clinical Research, Boston, MA, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Department of Medicine, Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Department of Medicine (Cardiology), Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Parkhomenko', 'Affiliation': 'Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA; The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31887-2']
291,32268161,Conventional Follow-up Versus Mobile Application Home Monitoring for Postoperative Anterior Cruciate Ligament Reconstruction Patients: A Randomized Controlled Trial.,"PURPOSE


To determine whether a mobile app can reduce the need for in-person visits and examine the resulting societal cost differences between mobile and conventional follow-up for postoperative anterior cruciate ligament (ACL) reconstruction patients.
METHODS


Study design was a single-center, 2-arm parallel group randomized controlled trial. All patients undergoing ACL reconstruction aged 16 to 70 years were screened for inclusion in the study. Competent use of a mobile device and ability to communicate in English was required. Patients were randomly assigned to receive follow-up via a mobile app or conventional appointments. Analysis was intention-to-treat. The primary outcome was the number of in-person visits to any health care professional during the first 6 postoperative weeks. Secondary outcomes included analysis of costs incurred by the health care system and personal patient costs related to both methods of follow-up. Patient-reported satisfaction and convenience scores, rates of complications, and clinical outcomes were also analyzed.
RESULTS


Sixty patients were analyzed. Participants in the app group attended a mean of 0.36 in-person visits versus 2.44 in-person visits in the conventional group (95% confidence interval 0.08-0.28; P < .0001). On average, patients in the app group spent $211 (Canadian dollars) less than the conventional group over 6 weeks (P < .0001) on personal costs related to follow-up. Health care system costs were also significantly less in the app group ($157.5 vs CAD $202.2; P < .0001). There was no difference between groups in patient satisfaction, convenience, complication rates, or clinical outcome measures.
CONCLUSIONS


Mobile follow-up can eliminate a significant number of in-person visits during the first 6 postoperative weeks in patients undergoing ACL reconstruction with cost savings to both the patient and health care system. This method should be considered for dissemination among similar orthopaedic procedures during early postoperative care.
LEVEL OF EVIDENCE


I: Prospective randomized controlled trial.",2020,Healthcare system costs were also significantly less in the app group (CAD $157.5 versus CAD $202.2; p<0.0001).,"['Sixty patients were analyzed', 'All patients undergoing ACL reconstruction aged 16-70 were screened for inclusion in the study', 'for Post-Operative ACL Reconstruction Patients']","['Conventional Follow-up Versus Mobile App Home Monitoring', 'follow-up via a mobile app or through conventional appointments']","['patient satisfaction, convenience, complication rates, or clinical outcome measures', 'analysis of costs incurred by the healthcare system and personal patient costs related to both methods of follow-up', 'Healthcare system costs', 'number of in-person visits to any healthcare professional', 'satisfaction and convenience scores, rates of complications, and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.258303,Healthcare system costs were also significantly less in the app group (CAD $157.5 versus CAD $202.2; p<0.0001).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada. Electronic address: james.higgins@one-mail.on.ca.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoit', 'Affiliation': 'Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jas', 'Initials': 'J', 'LastName': 'Chahal', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dwyer', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Mount Sinai Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Theodoropoulos', 'Affiliation': ""University of Toronto Orthopaedic Sports Medicine, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Women's College Hospital, Toronto, Ontario, Canada; Division of Orthopaedic Surgery, Mount Sinai Hospital, Toronto, Ontario, Canada.""}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.045']
292,32286683,Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1).,"BACKGROUND


Brodalumab is efficacious for the treatment of moderate-to-severe plaque psoriasis through 52 weeks.
OBJECTIVES


To evaluate the efficacy and safety of brodalumab through 120 weeks, including following withdrawal and retreatment.
METHODS


At baseline, patients were randomized to brodalumab (n = 222) or placebo (n = 220). At week 12, patients achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 (sPGA 0/1) with brodalumab were rerandomized to brodalumab (n = 83) or placebo (n = 84; later re-treated with brodalumab if sPGA ≥ 3 occurred), and patients receiving placebo switched to brodalumab (n = 208). Safety was assessed by exposure-adjusted rates of treatment-emergent adverse events.
RESULTS


Among those who achieved sPGA 0/1 at week 12 and were rerandomized to brodalumab, 96% and 80% using observed data, respectively, and 74% and 61% using nonresponder imputation, respectively, achieved 75% improvement in Psoriasis Area and Severity Index (PASI 75) and PASI 100 at week 120. Following withdrawal from brodalumab, return of disease occurred after a mean ± SD duration of 74·7 ± 50·5 days. Among those who switched from brodalumab to placebo at week 12, PASI 75 rates using observed data and nonresponder imputation were 55% and 51% at week 20, respectively and 94% and 75% at week 120, respectively; PASI 100 rates at week 120 were 75% and 60%, respectively. Efficacy was maintained through week 120 in those receiving brodalumab after placebo. No new safety signals were observed.
CONCLUSIONS


These findings indicate that brodalumab is efficacious and safe for continuous long-term treatment of psoriasis, and support the potential for response after discontinuation and retreatment.",2020,"No new safety signals were observed.
","['psoriasis through 120 weeks and after withdrawal and retreatment', ""patients achieving static physician's global assessment score of 0 or 1 (sPGA 0/1) with brodalumab""]","['brodalumab', 'placebo switched to brodalumab', 'placebo']","['PASI 75 rates using observed data and nonresponder imputation', 'PASI 100 rates', 'Safety', 'Efficacy', 'efficacy and safety', 'psoriasis area and severity index']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.179797,"No new safety signals were observed.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Baylor Scott & White, Dallas, TX, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St. Louis, MO, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Soung', 'Affiliation': 'Southern California Dermatology, Santa Ana, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'Direct Dermatology, Palo Alto, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Bausch Health US, LLC, Petaluma, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ, USA.'}]",The British journal of dermatology,['10.1111/bjd.19132']
293,32209728,Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing  in vitro  fertilization-embryo transfer.,"To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F ®  Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the Follitrope TM  Prefilled Syringe group, and 12.8 in the Gonal-F ®  Pen group. The 95% confidence interval in the oocyte number difference between the groups was [-0.1, 4.2], demonstrating that Follitrope TM  Prefilled Syringe was not inferior to Gonal-F ®  Pen. The clinical pregnancy rates (Follitrope TM  Prefilled Syringe vs. Gonal-F ®  Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope TM  Prefilled Syringe is safe and efficacious for ovarian stimulation.",2020,No clinically significant adverse events were observed in either group.,"['451 patients with infertility', 'patients undergoing  in vitro  fertilization-embryo transfer']","['Follitrope™ Prefilled Syringe or Gonal-F ®  Pen for ovarian stimulation', 'recombinant human follicle-stimulating hormone', 'recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation']","['clinical pregnancy rates', 'number of oocytes retrieved', 'adverse events', 'Efficacy and safety', 'ovarian responses', 'ongoing pregnancy rates', 'mean number of oocytes', 'total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C1609474', 'cui_str': 'Prefilled Syringe'}, {'cui': 'C0383405', 'cui_str': 'Gonal F'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues, endocrine therapy drugs'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0860848', 'cui_str': 'Blood oestradiol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",451.0,0.34722,No clinically significant adverse events were observed in either group.,"[{'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Reproductive Medicine, Zhengzhou, China.'}, {'ForeName': 'Songying', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Sir Run Run Shaw Hospital of Zhejiang University, Reproductive Medicine, Hangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Quan', 'Affiliation': 'Southern Medical University, Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Jieqiang', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Second Affiliated Hospital of Wenzhou Medical University, Reproductive Medicine, Wenzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Peking University Shenzhen Hospital, Reproductive Medicine, Shenzhen, China.'}, {'ForeName': 'Yuanhua', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan Medical College, Reproductive Medicine, Haikou, China.'}, {'ForeName': 'Weiying', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Hainan Medical College, Reproductive Medicine, Haikou, China.'}, {'ForeName': 'Yingpu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Reproductive Medicine, Zhengzhou, China.'}]",Aging,['10.18632/aging.102919']
294,31556633,Mixed results of a pilot RCT of time-limited schema mindfulness-based cognitive therapy and competitive memory therapy plus treatment as usual for personality disorders.,"Waiting lists for psychotherapy for patients with personality disorders are increasing; there is an imbalance between the number of patients seeking help and the amount of therapy available. Thus, there is a need for time-limited treatments that are effective for specific patients and their specific problems. This pilot randomized controlled trial aimed to investigate the effectiveness of two 8-week group modules + treatment as usual (TAU): schema mindfulness-based cognitive therapy (SMBCT) and competitive memory therapy (COMET) with special attention to predictors and mediators of change. Patients ( N  = 58) were randomized to either SMBCT + TAU or COMET + TAU. The dropout rate was 34%. Time effects were found for both treatments, but neither was more effective than the other, and around 23% showed deterioration after treatment. Explorative analyses suggested that predictors for change were severity of psychological distress and a demanding and/or punitive attitude toward oneself at baseline. Global severity index change in the beginning of the treatment mediated schema changes later on in treatment. SMBCT + TAU and COMET + TAU might be mostly suitable for patients with high levels of symptom severity followed by high scores on parent modes. More research is needed to tailor these time-limited therapies to specific personality problems. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Time effects were found for both treatments, but neither was more effective than the other, and around 23% showed deterioration after treatment.","['patients with personality disorders', 'Patients ( N  = 58']","['SMBCT + TAU and COMET + TAU', 'usual (TAU): schema mindfulness-based cognitive therapy (SMBCT) and competitive memory therapy (COMET', 'pilot RCT of time-limited schema mindfulness-based cognitive therapy and competitive memory therapy plus treatment', 'SMBCT + TAU or COMET + TAU']","['Global severity index change', 'dropout rate', 'Time effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",2019.0,0.0345343,"Time effects were found for both treatments, but neither was more effective than the other, and around 23% showed deterioration after treatment.","[{'ForeName': 'Michiel Floris', 'Initials': 'MF', 'LastName': 'van Vreeswijk', 'Affiliation': 'G-Kracht Mental Health Care Institute.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology.'}, {'ForeName': 'Aglaia Maria Emma', 'Initials': 'AME', 'LastName': 'Zedlitz', 'Affiliation': 'G-Kracht Mental Health Care Institute.'}, {'ForeName': 'Elisabeth Hyacintha Marie', 'Initials': 'EHM', 'LastName': 'Eurelings-Bontekoe', 'Affiliation': 'Institute of Psychology.'}]",Personality disorders,['10.1037/per0000361']
295,31647267,The independent roles of mindfulness and distress tolerance in treatment outcomes in dialectical behavior therapy skills training.,"Despite research supporting the effectiveness of dialectical behavior therapy (DBT) for borderline personality disorder (BPD), few studies have examined how DBT leads to clinical change. DBT is theorized to lead to improved clinical outcomes by enhancing the capacity for emotion regulation, including improvement in skills (e.g., mindfulness and distress tolerance) for managing emotional distress and impulsive behaviors. Therefore, the aim of this study was to test whether improvements in mindfulness and distress tolerance indirectly affect the relationship between DBT skills training and clinical outcomes. The sample consists of 84 patients diagnosed with BPD who were enrolled in a randomized controlled trial comparing 20 weeks of DBT-skills group (DBT-S) to an active waitlist control. Mindfulness and distress tolerance were assessed at baseline and at the end of the 20 weeks. BPD symptoms, general psychiatric symptoms, and social adjustment were assessed at the end of 20 weeks and combined into a latent variable representing a broad assessment of general psychopathology. Relative to the waitlist control group, improvements in mindfulness and distress tolerance each independently indirectly affected the relationship between DBT-S and posttreatment general psychopathology. Findings suggest that DBT-S exerts its effects on outcomes through improvements in mindfulness and distress tolerance. These findings support the significance of mindfulness and distress tolerance in DBT-S for BPD. Limitations, future directions, and clinical implications are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Relative to the waitlist control group, improvements in mindfulness and distress tolerance","['84 patients diagnosed with BPD', 'borderline personality disorder (BPD']","['DBT', 'DBT-skills group (DBT-S) to an active waitlist control', 'dialectical behavior therapy skills training', 'dialectical behavior therapy (DBT']","['BPD symptoms, general psychiatric symptoms, and social adjustment', 'mindfulness and distress tolerance', 'Mindfulness and distress tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",2019.0,0.0405944,"Relative to the waitlist control group, improvements in mindfulness and distress tolerance","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Zeifman', 'Affiliation': 'Department of Psychology, Ryerson University.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Boritz', 'Affiliation': 'Centre for Addiction and Mental Health.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Barnhart', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Labrish', 'Affiliation': 'Centre for Addiction and Mental Health.'}, {'ForeName': 'Shelley F', 'Initials': 'SF', 'LastName': 'McMain', 'Affiliation': 'Centre for Addiction and Mental Health.'}]",Personality disorders,['10.1037/per0000368']
296,32087126,Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial.,"BACKGROUND


Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.
METHODS


We did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.
FINDINGS


1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).
INTERPRETATION


We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.
FUNDING


National Institute for Health Research Health Technology Assessment.",2020,"Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data.","[""Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor"", '1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group', 'eczema', '12 hospitals and four primary care sites across the UK', '598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95', 'families with eczema, asthma, or allergic rhinitis', 'high-risk children', 'Term newborns with a family history of atopic disease']",['application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group'],"['eczema', 'risk of skin infections', 'Adherence', 'Mean number of skin infections', 'eczema at age 2 years']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0730870', 'cui_str': 'Diprobase'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1138077', 'cui_str': 'Doublebase'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0037278', 'cui_str': 'Skin Diseases, Infectious'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1394.0,0.255502,"Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data.","[{'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Brown', 'Affiliation': 'Skin Research Group, School of Medicine, University of Dundee, Dundee, UK; Department of Dermatology, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ridd', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'Rotherham NHS Foundation Trust, UK.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection and Immunity, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Tracey H', 'Initials': 'TH', 'LastName': 'Sach', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK.""}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Mitchell', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Swinden', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Tarr', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Davies-Jones', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jay', 'Affiliation': ""Sheffield Children's Hospital, Sheffield, UK.""}, {'ForeName': 'Maeve M', 'Initials': 'MM', 'LastName': 'Kelleher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK; National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK. Electronic address: hywel.williams@nottingham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32984-8']
297,32246899,Analysis of 4-fluoroamphetamine in cerumen after controlled oral application.,"Cerumen was found to be a promising alternative specimen for the detection of drugs. In a pilot study, drugs of abuse were identified at a higher detection rate and a longer detection window in cerumen than in urine. In this study, cerumen from subjects was analyzed after they ingested the designer stimulant 4-fluoroamphetamine (4-FA) in a controlled manner.
METHODS


Twelve subjects ingested placebo and 100 mg of 4-FA. Five of them were also given 150 mg of 4-FA in 150 mL Royal Club bitter lemon drink at least after 7 days. Cerumen was sampled using cotton swabs at baseline, 1 h after the ingestion of the drug and at the end of the study day (12 h). After extraction with ethyl acetate followed by solid-phase extraction, the extracts were analyzed using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
RESULTS AND DISCUSSION


In the cerumen of all 12 subjects, 4-FA was detected 12 h after its ingestion; in most subjects, cerumen was detected after 1 h of ingestion, ranging from 0.06 to 13.90 (median 1.52) ng per swab. The detection of 4-FA in cerumen sampled 7 days or more after the first dose suggested a long detection window of cerumen.
CONCLUSIONS


Cerumen can be successfully used to detect a single drug ingestion even immediately after the ingestion when a sufficient amount of cerumen is used.",2020,Cerumen can be successfully applied to detect a single drug ingestion even shortly after ingestion provided a sufficient amount of cerumen can be sampled.,['Twelve subjects ingested'],"['ethyl acetate', '4-FA', 'placebo, 100 mg of 4-FA', 'designer stimulant 4-fluoroamphetamine (4-FA', '4-fluoroamphetamine']",[],"[{'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0059747', 'cui_str': 'ethyl acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0048271', 'cui_str': '4-fluoroamphetamine'}]",[],12.0,0.0489059,Cerumen can be successfully applied to detect a single drug ingestion even shortly after ingestion provided a sufficient amount of cerumen can be sampled.,"[{'ForeName': 'Sylvia I', 'Initials': 'SI', 'LastName': 'Meier', 'Affiliation': 'Institute of Legal Medicine, Goethe University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Petzel-Witt', 'Affiliation': 'Institute of Legal Medicine, Goethe University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schubert-Zsilavecz', 'Affiliation': 'Institute for Pharmaceutical Chemistry, Goethe University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'de Sousa Fernandes Perna', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, Goethe University Frankfurt, Frankfurt/Main, Germany.'}]",Drug testing and analysis,['10.1002/dta.2796']
298,30948254,Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial.,"OBJECTIVES


Peripheral intravenous (IV) cannulation is the most common procedure performed in the emergency department (ED). Elastic tourniquets (ETs) and blood pressure cuffs (BPCs) are frequently used for venodilation. Although BPCs lead to increased venodilation and decreased compressibility, it is unclear whether this translates into a meaningful patient-centered outcome. This study aimed to determine whether one method is superior for success on the first attempt.
METHODS


This was a prospective, single-blinded, randomized controlled trial in the ED of a tertiary care center. A convenience sample of adult patients was randomly assigned to an ET or BPC with a cover concealing the type of tourniquet. The primary outcome was success rate on the first attempt. Secondary outcomes were number of attempts, number of providers, and rate of rescue techniques.
RESULTS


Of the 121 patients enrolled, 119 qualified for analysis. In the ET group, 42 of 59 patients (71%) had successful IV cannulation on first attempt compared with 43 of 60 (72%) in the BPC group (P = .95). The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly. A history of difficult IV access and site other than the antecubital vein were associated with decreased success.
CONCLUSIONS


ETs and BPCs performed similarly in providing venodilation for successful peripheral IV cannulation. History of difficult IV access and IV site are important factors in determining the likelihood of success.",2019,"The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly.","['121 patients enrolled, 119 qualified for analysis', 'A convenience sample of adult patients']","['ET or BPC', 'tourniquet techniques', 'Peripheral intravenous (IV) cannulation']","['successful IV cannulation', 'number of nurses', 'peripheral intravenous cannulation success', 'number of attempts, number of providers, and rate of rescue techniques', 'Elastic tourniquets (ETs) and blood pressure cuffs (BPCs', 'success rate on the first attempt']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff, device (physical object)'}]",121.0,0.196793,"The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Lund', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Micah D', 'Initials': 'MD', 'LastName': 'Nichols', 'Affiliation': 'Bethel University, St Paul, MN, United States of America.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kummer', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN, United States of America. Electronic address: kummer.tobias@mayo.edu.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.03.034']
299,29851748,The Applicability of a High-Intensity Functional Exercise Program Among Older People With Dementia Living in Nursing Homes.,"BACKGROUND AND PURPOSE


Exercise programs for people with dementia need to be optimized. We therefore evaluated the applicability of a high-intensity functional exercise program among people with dementia in nursing homes with regard to attendance, achieved exercise intensity, adverse events, a focus on dementia type, and whether symptoms of dementia or other medical conditions common in this population were associated with program applicability.
METHODS


The Umeå Dementia and Exercise study, a cluster-randomized controlled trial set in 16 nursing homes in Umeå, Sweden. Ninety-three people with dementia (mean [SD] Mini-Mental State Examination score of 15.4 [3.4]) were randomized to the exercise intervention. Thirty-four participants had Alzheimer's disease (AD) and 59 non-Alzheimer's dementia (non-AD). High-Intensity Functional Exercise (HIFE) program was conducted in groups of 3 to 8 participants. Two physiotherapists led 5 sessions (45 minutes each) per fortnight for 4 months (total 40 sessions).
RESULTS


Median attendance rate was 82.5%. Lower limb strength exercises were performed at high or medium intensity at a median interquartile range of 94.7% (77.8%-100%) of attended sessions. Participants with non-AD performed more sessions with high intensity in strength exercises than participants with AD (median interquartile range, 53.8% [25.7%-80%] vs 34.9% [2.02%-62.9%]; P = .035). Balance exercises were performed at high intensity at a median interquartile range of 75% (33.3%-88.6%). Adverse events (all minor and temporary, mostly musculoskeletal) occurred during the exercise sessions in 16% of attended sessions. Low motivation was the most common barrier for attendance. Buildup period, low motivation, and pain were common barriers for achieving high intensity in balance and strength exercises, and fear was a barrier in balance exercises. Of medical conditions, only behavioral and psychological symptoms of dementia, including apathy, were negatively associated with applicability.
CONCLUSION


A group-based, supervised, and individualized high-intensity functional exercise program seems to be applicable with regard to attendance, achieved intensity, and adverse events during the exercise sessions, in people with mild to moderate dementia in nursing homes. Effective strategies to enhance motivation to participate in exercise, as well as prevention and treatment of pain and behavioral and psychological symptoms of dementia, are important when promoting exercise participation in this population.",2019,"Participants with non-AD performed more sessions with high intensity in strength exercises than participants with AD (median interquartile range, 53.8% [25.7%-80%] vs 34.9% [2.02%-62.9%]; P = .035).","['Ninety-three people with dementia (mean [SD] Mini-Mental State Examination score of 15.4 [3.4', 'groups of 3 to 8 participants', 'people with mild to moderate dementia in nursing homes', 'people with dementia in nursing homes with regard to attendance', 'people with dementia', '16 nursing homes in Umeå, Sweden', 'Older People With Dementia Living in Nursing Homes', ""Thirty-four participants had Alzheimer's disease (AD) and 59 non-Alzheimer's dementia (non-AD""]","['High-Intensity Functional Exercise Program', 'high-intensity functional exercise program', 'exercise intervention', 'High-Intensity Functional Exercise (HIFE) program']","['Adverse events (all minor and temporary, mostly musculoskeletal', 'Lower limb strength exercises', 'Median attendance rate', 'Buildup period, low motivation, and pain']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",93.0,0.129044,"Participants with non-AD performed more sessions with high intensity in strength exercises than participants with AD (median interquartile range, 53.8% [25.7%-80%] vs 34.9% [2.02%-62.9%]; P = .035).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sondell', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Littbrand', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000199']
300,31838029,Diuretic Strategies for Loop Diuretic Resistance in Acute Heart Failure: The 3T Trial.,"OBJECTIVES


This study compared combination diuretic strategies in acute heart failure (AHF) complicated by diuretic resistance (DR).
BACKGROUND


Combination diuretic regimens to overcome loop DR are commonly used but with limited evidence.
METHODS


This study was a randomized, double-blinded trial in 60 patients hospitalized with AHF and intravenous (IV) loop DR. Patients were randomized to oral metolazone, IV chlorothiazide, or tolvaptan therapy. All patients received concomitant high-dose IV infusions of furosemide. The primary outcome was 48-h weight loss.
RESULTS


The cohort exhibited DR prior to enrollment, producing 1,188 ± 476 ml of urine in 12 h during high-dose loop diuretic therapy (IV furosemide: 612 ± 439 mg/day). All 3 interventions significantly improved diuretic efficacy (p < 0.001). Compared to metolazone (4.6 ± 2.7 kg), neither IV chlorothiazide (5.8 ± 2.7 kg; 1.2 kg [95% confidence interval (CI)]: -2.9 to 0.6; p = 0.292) nor tolvaptan (4.1 ± 3.3 kg; 0.5 kg [95% CI: -1.5 to 2.4; p = 0.456) resulted in more weight loss at 48 h. Median (interquartile range [IQR]) cumulative urine output increased significantly and did not differ among those receiving metolazone (7.78 [IQR: 6.59 to 10.10] l) and chlorothiazide (8.77 [IQR: 7.37 to 10.86] l; p = 0.245) or tolvaptan (9.70 [IQR: 6.36 to 13.81] l; p = 0.160). Serum sodium decreased less with tolvaptan than with metolazone (+4 ± 5 vs. -1 ± 3 mEq/l; p = 0.001), but 48-h spot urine sodium was lower with tolvaptan (58 ± 25 mmol/l) than with metolazone (104 ± 16 mmol/l; p = 0.002) and with chlorothiazide (117 ± 14 mmol/l; p < 0.001).
CONCLUSIONS


In this moderately sized DR trial, weight loss was excellent with the addition of metolazone, IV chlorothiazide, or tolvaptan to loop diuretics, without a detectable between-group difference. (Comparison of Oral or Intravenous Thiazides vs. tolvaptan in Diuretic Resistant Decompensated Heart Failure [3T]; NCT02606253).",2020,All 3 interventions significantly improved diuretic efficacy (p < 0.001).,"['acute heart failure (AHF) complicated by diuretic resistance (DR', 'Diuretic Resistant Decompensated Heart', '60 patients hospitalized with AHF and intravenous (IV) loop DR', 'Acute Heart', 'Failure']","['oral metolazone, IV chlorothiazide, or tolvaptan therapy', 'metolazone', 'metolazone, IV chlorothiazide', 'Oral or Intravenous Thiazides vs. tolvaptan', 'chlorothiazide', 'furosemide']","['weight loss', 'Serum sodium', '48-h spot urine sodium', 'Cumulative urine output', 'diuretic efficacy', '48-h weight loss', 'Failure']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025854', 'cui_str': 'Metolazone'}, {'cui': 'C0008273', 'cui_str': 'Chlorothiazide'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0457208', 'cui_str': 'Spot urine sample (specimen)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",1188.0,0.382007,All 3 interventions significantly improved diuretic efficacy (p < 0.001).,"[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville Tennessee; Department of Pharmacy, Vanderbilt University Medical Center, Nashville Tennessee. Electronic address: Zachary.l.cox@vumc.org.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hung', 'Affiliation': 'Division of Cardiology, Vanderbilt University Medical Center, Nashville Tennessee.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lenihan', 'Affiliation': 'Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Division of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.09.012']
301,32267878,Remote ischemic preconditioning does not influence lectin pathway protein levels in head and neck cancer patients undergoing surgery.,"BACKGROUND


Cancer patients who undergo tumor removal, and reconstructive surgery by transfer of a free tissue flap, are at high risk of surgical site infection and ischemia-reperfusion injury. Complement activation through the lectin pathway (LP) may contribute to ischemia-reperfusion injury. Remote ischemic preconditioning (RIPC) is a recent experimental treatment targeting ischemia-reperfusion injury. The study aims were to investigate LP protein plasma levels in head and neck cancer patients compared with healthy individuals, to explore whether RIPC affects LP protein levels in head and neck cancer surgery, and finally to examine the association between postoperative LP protein levels and the risk of surgical site infection.
METHODS


Head and neck cancer patients (n = 60) undergoing tumor resection and reconstructive surgery were randomized 1:1 to RIPC or sham intervention administered intraoperatively. Blood samples were obtained preoperatively, 6 hours after RIPC/sham, and on the first postoperative day. LP protein plasma levels were measured utilizing time-resolved immunofluorometric assays.
RESULTS


H-ficolin and M-ficolin levels were significantly increased in cancer patients compared with healthy individuals (both P ≤ 0.02). Conversely, mannan-binding lectin (MBL)-associated serine protease (MASP)-1, MASP-3, collectin liver-1 (CL-L1), and MBL-associated protein of 44 kilodalton (MAp44) levels were decreased in cancer patients compared with healthy individuals (all P ≤ 0.04). A significant reduction in all LP protein levels was observed after surgery (all P < 0.001); however, RIPC did not affect LP protein levels. No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13).
CONCLUSIONS


The LP was altered in head and neck cancer patients. LP protein levels were reduced after surgery, but intraoperative RIPC did not influence the LP. Postoperative LP protein levels were not associated with surgical site infection.",2020,"No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13).
","['head and neck cancer patients undergoing surgery', 'head and neck cancer patients', 'Cancer patients who undergo tumor removal, and reconstructive surgery by transfer of a free tissue flap', 'Head and neck cancer patients (n = 60) undergoing tumor resection and reconstructive surgery', 'head and neck cancer patients compared with healthy individuals']","['Remote ischemic preconditioning (RIPC', 'RIPC or sham intervention administered intraoperatively', 'Remote ischemic preconditioning']","['LP protein levels', 'H-ficolin and M-ficolin levels', 'mannan-binding lectin (MBL)-associated serine protease (MASP)-1, MASP-3, collectin liver-1 (CL-L1), and MBL-associated protein of 44 kilodalton (MAp44) levels', 'postoperative LP protein levels', 'Postoperative LP protein levels', 'LP protein plasma levels']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0441031', 'cui_str': 'Free flap'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}]","[{'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0217532', 'cui_str': 'ficolin'}, {'cui': 'C0673667', 'cui_str': 'M-ficolin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0960371', 'cui_str': 'PRSS1 protein, human'}, {'cui': 'C0377274', 'cui_str': 'Collectin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",60.0,0.045339,"No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13).
","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Andreas Engel', 'Initials': 'AE', 'LastName': 'Krag', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie Brogaard', 'Initials': 'JB', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Birgitte Jul', 'Initials': 'BJ', 'LastName': 'Kiil', 'Affiliation': 'Department of Plastic and Breast Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0230411']
302,32272253,The clinical utility of fluoroscopic versus CT guided percutaneous transpedicular core needle biopsy for spinal infections and tumours: a randomized trial.,"BACKGROUND CONTEXT


Biopsy is important to obtain microbiological and histopathological diagnosis in spine infections and tumors. To date, there have been no prospective randomized trials comparing fluoroscopic guided and computed tomography (CT) transpedicular biopsy techniques. The goal of this study was to evaluate the accuracy, safety, and diagnostic outcome of these two diagnostic techniques.
PURPOSE


To evaluate the accuracy, safety, and diagnostic outcome of fluoroscopic guided and CT transpedicular biopsy techniques.
STUDY DESIGN


Prospective randomized trial.
PATIENT SAMPLE


Sixty consecutive patients with clinical symptoms and radiological features suggestive of spinal infection or malignancy were recruited and randomized into fluoroscopic or CT guided spinal biopsy groups. Both groups were similar in terms of patient demographics, distribution of spinal infections and malignancy cases, and the level of biopsies.
OUTCOME MEASURES


The primary outcome measure was diagnostic accuracy of both methods, determined based on true positive, true negative, false positive, and false negative biopsy findings. Secondary outcome measures included radiation exposure to patients and doctors, complications, and postbiopsy pain score.
METHODS


A transpedicular approach was performed with an 8G core biopsy needle. Specimens were sent for histopathological and microbiological examinations. Diagnosis was made based on biopsy results, clinical criteria and monitoring of disease progression during a 6-month follow up duration. Clinical criteria included presence of risk factors, level of inflammatory markers and magnetic resonance imaging findings. Radiation exposure to patients and doctors was measured with dosimeters.
RESULTS


There was no significant difference between the diagnostic accuracy of fluoroscopic and CT guided spinal biopsy (p=0.67) or between the diagnostic accuracy of spinal infection and spinal tumor in both groups (p=0.402 for fluoroscopy group and p=0.223 for CT group). Radiation exposure to patients was approximately 26 times higher in the CT group. Radiation exposure to doctors in the CT group was approximately 2 times higher compared to the fluoroscopic group if a lead shield was not used. Lead shields significantly reduced radiation exposure to doctors anywhere from 2 to 8 times. No complications were observed for either group and the differences in postbiopsy pain scores were not significant.
CONCLUSIONS


The accuracy, procedure time, complication rate and pain score for both groups were similar. However, radiation exposure to patients and doctors were significantly higher in the CT group without lead protection. With lead protection, radiation to doctors reduced significantly.",2020,Radiation exposure to doctors in the CT group was approximately two times higher compared to the fluoroscopic group if a lead shield was not used.,"['SAMPLE: Sixty consecutive patients with clinical symptoms and radiological features suggestive of spinal infection or malignancy', 'Spinal Infections and Tumours']","['Fluoroscopic vs. CT Guided Percutaneous Transpedicular Core Needle Biopsy', 'fluoroscopic and CT guided spinal biopsy groups', 'fluoroscopic guided and CT transpedicular biopsy techniques', 'fluoroscopic guided and computed tomography (CT) transpedicular biopsy techniques', 'CT']","['diagnostic accuracy of both methods, determined based on true positive, true negative, false positive and false negative biopsy findings', 'diagnostic accuracy of fluoroscopic and CT guided spinal biopsy', 'accuracy, safety and diagnostic outcome', 'post biopsy pain scores', 'radiation exposure to patients and doctors, complications and post-biopsy pain score', 'patient demographics, distribution of spinal infections and malignancy cases and the level of biopsies', 'accuracy, procedure time, complication rate and pain score', 'diagnostic accuracy of spinal infection and spinal tumor']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0442371', 'cui_str': 'Transpedicular approach'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205560', 'cui_str': 'True negative'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C1287401', 'cui_str': 'Biopsy finding'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0949092', 'cui_str': 'Pain post biopsy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037930', 'cui_str': 'Neoplasm of spinal cord'}]",60.0,0.0484989,Radiation exposure to doctors in the CT group was approximately two times higher compared to the fluoroscopic group if a lead shield was not used.,"[{'ForeName': 'She Ann', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, 50603, Malaysia.'}, {'ForeName': 'Chee Kidd', 'Initials': 'CK', 'LastName': 'Chiu', 'Affiliation': 'Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, 50603, Malaysia.'}, {'ForeName': 'Chris Yin Wei', 'Initials': 'CYW', 'LastName': 'Chan', 'Affiliation': 'Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, 50603, Malaysia. Electronic address: chrnat01@yahoo.com.'}, {'ForeName': 'Nur Adura', 'Initials': 'NA', 'LastName': 'Yaakup', 'Affiliation': 'Department of Biomedical Imaging, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jeannie Hsiu Ding', 'Initials': 'JHD', 'LastName': 'Wong', 'Affiliation': 'Department of Biomedical Imaging, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khairul Azmi Abd', 'Initials': 'KAA', 'LastName': 'Kadir', 'Affiliation': 'Department of Biomedical Imaging, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mun Keong', 'Initials': 'MK', 'LastName': 'Kwan', 'Affiliation': 'Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, 50603, Malaysia.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.03.015']
303,30908853,Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint.,"OBJECTIVE


The present study was undertaken to assess the comparative responsiveness of outcome measures used for the assessment of pain and function in individuals with osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint.
METHODS


Eighty-eight patients (mean ± SD age 57.2 ± 10.2 years) with OA of the first MTP joint who participated in a randomized trial completed the Foot Health Status Questionnaire (FHSQ), the Foot Function Index Revised Short Form (FFI-RS), and 100-mm visual analog scales (VAS) of pain and stiffness at baseline and 12 weeks. Responsiveness of the subscales for each outcome measure was determined using paired t-tests, Cohen's d coefficient, the standardized response mean (SRM), and the Guyatt index (GI). Sample size estimations were calculated based on minimal important differences (MIDs).
RESULTS


All outcome measures were sensitive to change and demonstrated at least medium effect sizes. Three outcome measures exhibited large or very large effect sizes for Cohen's d coefficient, the SRM, and the GI: the FHSQ pain subscale (d = 1.03; SRM 1.10, GI score 1.30), the FFI-RS pain subscale (d = 1.09; SRM 1.05, GI score 1.73), and the 100-mm VAS of pain severity while walking (d = 1.22; SRM 1.07, GI score 1.78). Sample size calculations indicated that between 20 and 33 participants per group would be required to detect MIDs using these measures.
CONCLUSION


The FHSQ pain subscale, FFI-RS pain subscale, and the 100-mm VAS of pain severity while walking are the most responsive outcome measures for the assessment of pain and function in individuals with OA of the first MTP joint. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.",2020,"Three outcome measures exhibited large or very large effect sizes for Cohen's d, SRM, and GI: the FHSQ pain subscale (d=1.03; SRM=1.10, GI=1.30), the FFI-R pain subscale (d=1.09; SRM=1.05, GI=1.73), and the 100 mm VAS of pain severity while walking (d=1.22; SRM=1.07, GI=1.78).","['individuals with first metatarsophalangeal joint osteoarthritis (1 st  MTPJ OA', 'mean age [SD] 57.2 [10.2] years) with 1 st  MTPJ OA who participated', 'First Metatarsophalangeal Joint Osteoarthritis', 'Eighty-eight people ']",[],"['FFI-R pain subscale', 'standardised response mean (SRM), and the Guyatt index (GI', ""large or very large effect sizes for Cohen's d, SRM, and GI: the FHSQ pain subscale"", 'FHSQ pain subscale, FFI-RS pain subscale', 'Foot Health Status Questionnaire (FHSQ), the Foot Function Index Revised Short Form (FFI-RS), and 100 mm visual analog scales (VAS) of pain and stiffness', 'Pain and Function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal Joint'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0452557,"Three outcome measures exhibited large or very large effect sizes for Cohen's d, SRM, and GI: the FHSQ pain subscale (d=1.03; SRM=1.10, GI=1.30), the FFI-R pain subscale (d=1.09; SRM=1.05, GI=1.73), and the 100 mm VAS of pain severity while walking (d=1.22; SRM=1.07, GI=1.78).","[{'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia, and Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Auhl', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pazit', 'Initials': 'P', 'LastName': 'Levinger', 'Affiliation': 'La Trobe University and National Ageing Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, UK, and Academic Rheumatology Centre, Midlands Partnership NHS Trust, Stoke-on-Trent, UK.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia.'}]",Arthritis care & research,['10.1002/acr.23883']
304,30908867,Feasibility and Preliminary Outcomes of a Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement.,"OBJECTIVE


To explore the feasibility, fidelity, safety, and preliminary outcomes of a physical therapist-administered physical activity (PA) intervention after total knee replacement (TKR).
METHODS


People who had undergone a unilateral TKR and were receiving outpatient physical therapy (PT) were randomized to a control or intervention group. Both groups received standard PT for TKR. The intervention included being provided with a Fitbit Zip, step goals, and 1 phone call a month for 6 months after discharge from PT. Feasibility was measured by rates of recruitment and retention, safety was measured by the frequency of adverse events, and fidelity was measured by adherence to the weekly steps/day goal created by the physical therapist and participant monitoring of steps/day. An Actigraph GT3X measured PA, which was quantified as steps/day and minutes/week of engaging in moderate-to-vigorous PA. Our preliminary outcome was the difference in PA 6 months after discharge from PT between the control and intervention groups.
RESULTS


Of the 43 individuals who were enrolled, 53.4% were women, the mean ± SD age was 67.0 ± 7.0 years, and the mean ± SD body mass index was 31.5 ± 5.9 kg/m 2  . For both the control and intervention groups, the recruitment and retention rates were 64% and 83.7%, respectively, and adherence to the intervention ranged from 45% to 60%. No study-related adverse events occurred. The patients in the intervention group accumulated a mean 1,798 more steps/day (95% confidence interval [95% CI] 240, 3,355) and spent 73.4 more minutes/week (95% CI -14.1, 160.9) engaging in moderate-to-vigorous PA at 6 months than those in the control group.
CONCLUSION


A physical therapist-administered PA intervention is feasible and safe, demonstrates treatment fidelity, and may increase PA after TKR. Future research is needed to establish the effectiveness of the intervention.",2020,"the recruitment and retention rates were 64% and 83.7%, respectively, no study-related adverse events occurred, and adherence to the intervention ranged from 45-60%.","['total knee replacement', '43 people enrolled (mean(SD) age = 67.0 (7.0), BMI = 31.5 (5.9), 53.4% women', 'People with a unilateral TKR in outpatient PT']","['physical therapist-administered PA intervention', 'standard PT for TKR', 'physical therapist-administered physical activity intervention', 'physical therapist-administered physical activity (PA) intervention after total knee replacement (TKR']","['rates of recruitment and retention, safety by the frequency of adverse events, and fidelity of the intervention by adherence', 'adverse events', 'retention rates']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0423838,"the recruitment and retention rates were 64% and 83.7%, respectively, no study-related adverse events occurred, and adherence to the intervention ranged from 45-60%.","[{'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Christiansen', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Thoma', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Hiral', 'Initials': 'H', 'LastName': 'Master', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Voinier', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Schmitt', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Ziegler', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaValley', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'University of Delaware, Newark.'}]",Arthritis care & research,['10.1002/acr.23882']
305,32165032,"Efficacy of Parent-Delivered, Home-Based Therapy for Tics.","BACKGROUND


Although behavioral therapy is an effective approach to reduce tics in children and adults, there is an insufficient availability and accessibility of behavioral therapy in the community.
OBJECTIVE


The goal of the study was to test the clinical efficacy of home-based, parent-provided behavioral therapy in children with Tourette syndrome aged seven to 13 years.
METHOD


An instructional habit reversal training-based video and guide was developed for use by parents. Eligible families, in this 10-week study, were enrolled in either a home-based therapy (DVD) group (received disk and written instructions) or an in-person therapist group (had scheduled visits with the therapist). Outcome scales included the Yale Global Tic Severity Scale, both the total Tic Severity Score and total Global Severity Score, and the parent report of Clinical Global Impressions of Improvement.
RESULTS


Forty-four children (mean age = 10.21 ± 1.69 years) were enrolled into either the DVD (n = 33) or in-person therapist (n = 11) groups. Eighteen completed the study-eight in the DVD and 10 in the in-person therapist group. Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P < 0.001) and in-person therapist 26.7% (P < 0.001).
CONCLUSIONS


Home-based, parent-administered habit reversal training behavioral therapy is efficacious for reducing tics in children. Telephone contacts early in the DVD treatment course might reduce the number of dropouts.",2020,"Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P ","['children and adults', 'children', 'Tics', 'Forty-four children (mean age\xa0=\xa010.21\xa0±\xa01.69\xa0years) were enrolled into either the DVD (n\xa0=\xa033) or in-person therapist (n\xa0=\xa011) groups', 'Eighteen completed the study-eight in the DVD and 10 in the in-person therapist group', 'children with Tourette syndrome aged seven to 13\xa0years']","['home-based therapy (DVD) group (received disk and written instructions) or an in-person therapist group (had scheduled visits with the therapist', 'home-based, parent-provided behavioral therapy', 'Parent-Delivered, Home-Based Therapy']","['Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score', 'Yale Global Tic Severity Scale, both the total Tic Severity Score and total Global Severity Score, and the parent report of Clinical Global Impressions of Improvement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",44.0,0.0842714,"Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P ","[{'ForeName': 'Harvey S', 'Initials': 'HS', 'LastName': 'Singer', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland; Kennedy Krieger Institute, Baltimore, Maryland. Electronic address: hsinger@jhmi.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McDermott', 'Affiliation': 'Kennedy Krieger Institute, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ferenc', 'Affiliation': 'Kennedy Krieger Institute, Baltimore, Maryland.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Specht', 'Affiliation': 'Weill-Cornell Medical School, New York, New York.'}, {'ForeName': 'E Mark', 'Initials': 'EM', 'LastName': 'Mahone', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland; Kennedy Krieger Institute, Baltimore, Maryland.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2019.12.015']
306,32278669,Effects of medicated enema and nasal drops using Triphaladi oil in the management of obesity - A pilot study.,"An open label, randomized, comparative, interventional pilot study was done to assess the effect of Lekhana Basti (medicated enema) and Rechana Nasya Karma (Errhine therapy) in the management of Sthoulya with special reference to obesity. In the study 30 clinically diagnosed patient of either sex were randomly divided into two groups. In Basti group, Lekhana Basti in Karma Basti manner was given for 30 days. Anuvasana Basti (enema with Triphaladi Taila) in the dose of 120 mL and Asthapana Basti (enema with Triphaladi decoction etc.) in the dose of approximately 960 mL was given. In Nasya group, Rechananasya on alternate days was given with Triphaladi (oil) in the dose of 0.5 mL per nostril for total 28 days. The patients were assessed on objective criteria such as such as weight, chest circumference, mid-arm circumference, mid-thigh circumference, triceps skin fold thickness, sub-scapular skin fold thickness, abdominal skin fold thickness, waist-hip ratio and lipid profile. It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile. The results suggest that the Nasya Karma may be developed as a better practical approach in obesity management.",2020,"It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile.","['Sthoulya with special reference to obesity', '30 clinically diagnosed patient of either sex']","['Asthapana Basti (enema with Triphaladi decoction etc', 'medicated enema and nasal drops using Triphaladi oil', 'Lekhana Basti (medicated enema) and Rechana Nasya Karma (Errhine therapy', 'Anuvasana Basti (enema with Triphaladi Taila', 'Triphaladi (oil']","['objective criteria such as such as weight, chest circumference, mid-arm circumference, mid-thigh circumference, triceps skin fold thickness, sub-scapular skin fold thickness, abdominal skin fold thickness, waist-hip ratio and lipid profile']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0424680', 'cui_str': 'Skin-fold thickness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0578529', 'cui_str': 'Scapular skin fold thickness'}, {'cui': 'C0578530', 'cui_str': 'Abdominal skin fold thickness'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",30.0,0.0370078,"It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile.","[{'ForeName': 'Sarvesh Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan, India. Electronic address: sarveshksingh21@gmail.com.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Swami', 'Affiliation': 'Department of Panchakarma, Dr.S.S.R.A.U, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kshipra', 'Initials': 'K', 'LastName': 'Rajoria', 'Affiliation': 'Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.02.001']
307,32276098,Phase 3 Study of Palonosetron IV Infusion Vs. IV Bolus for Chemotherapy-Induced Nausea and Vomiting Prophylaxis After Highly Emetogenic Chemotherapy.,"CONTEXT


Palonosetron (PALO) is one of the two active components of NEPA, the fixed-combination antiemetic comprising netupitant (oral)/fosnetupitant (IV) and PALO. To increase the convenience of NEPA administration, especially for patients with swallowing difficulties, an IV NEPA formulation has been developed, where PALO is administered as a 30-minute infusion instead of the approved 30-second bolus.
OBJECTIVES


To determine the efficacy and safety of the PALO component used in IV NEPA.
METHODS


Noninferiority, double-blind, and randomized Phase 3 trial in chemotherapy-naive adult patients with cancer requiring highly emetogenic chemotherapy. Patients were randomized to receive a single dose of PALO 0.25 mg administered IV either as a 30-minute infusion or as a 30-second bolus before highly emetogenic chemotherapy. The primary objective was to demonstrate noninferiority of the 30-minute infusion vs. 30-second bolus in terms of complete response (CR; no emesis and no rescue medication) in the acute phase. Secondary efficacy endpoints were CR in the delayed and overall phases and no emesis and no rescue medication in all phases. Safety was a secondary endpoint.
RESULTS


Overall, 440 patients received study treatment. In the infusion group, 186 (82.7%) patients reported CR in the acute phase vs. 186 (86.5%) patients in the bolus group, demonstrating the noninferiority of PALO infusion vs. bolus (P < 0.001). Secondary endpoints showed similar results between the two treatment groups.
CONCLUSION


PALO 0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase. These results support the use of PALO 0.25 mg as a component of IV NEPA.",2020,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"['naive adult cancer patients requiring highly emetogenic chemotherapy (HEC', '440 patients received study treatment', 'patients with swallowing difficulties']","['chemotherapy', 'palonosetron intravenous (IV) infusion versus IV bolus for chemotherapy', 'PALO']","['CR in the delayed and overall phases, and no emesis and no rescue medication', 'complete response (CR; no emesis, no rescue medication', 'nausea and vomiting prophylaxis', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.119251,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"[{'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Neuperlach/Klinikum Harlaching, Munich, Germany. Electronic address: meinolf.karthaus@klinikum-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland; Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institute of Oncology Prof. Dr. Ion Chiricuţã and UMF Iuliu Haţieganu, Cluj-Napoca, Romania.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.03.034']
308,31926854,"Mineralocorticoid Receptor Antagonists, Blood Pressure, and Outcomes in Heart Failure With Reduced Ejection Fraction.","OBJECTIVES


The purpose of this study was to investigate the effects of mineralocorticoid receptor antagonists (MRAs) on systolic blood pressure (SBP) and outcomes according to baseline SBP in patients with heart failure with reduced ejection fraction (HFrEF).
BACKGROUND


MRAs are greatly underused in patients with HFrEF, often because of fear of adverse events. Concern about hypotension has been raised by the demonstration that MRAs are particularly effective treatment for resistant hypertension.
METHODS


The effect of MRA therapy was studied in 4,396 patients with HFrEF randomized in the RALES (Randomized Aldactone Evaluation Study) and EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) trials.
RESULTS


Mean SBP change from baseline to 6 months was +1.4 ± 18.1 mm Hg in the placebo group and -1.2 ± 17.9 mm Hg in the MRA group. The between-treatment difference was 2.6 mm Hg (95% confidence interval [CI]: 1.5 to 3.6; p < 0.001). All outcomes were reduced by MRA therapy overall, with consistent effects across SBP categories (e.g., all-cause mortality, overall hazard ratio [HR] of 0.72; 95% CI: 0.64 to 0.82; p < 0.001; SBP ≤105 mm Hg; HR: 0.72; 95% CI: 0.56 to 0.94; SBP >105 to ≤115 mm Hg; HR: 0.78; 95% CI: 0.60 to 1.02; SBP >115 to ≤125 mm Hg; HR: 0.71; 95% CI: 0.53 to 0.94; SBP >125 to ≤135 mm Hg; HR: 0.79; 95% CI: 0.57 to 1.10; and SBP > 135 mm Hg; HR: 0.67; 95% CI: 0.50 to 0.90; p for interaction = 0.95). Hypotension was infrequent and not more common with MRA therapy than with placebo, overall (4.6% vs. 3.9%; p = 0.25) or in any SBP category.
CONCLUSIONS


MRA treatment had little effect on SBP in patients with HFrEF, and the clinical benefits were not modified by baseline SBP. MRA treatment infrequently caused hypotension, even when the baseline SBP was low. The treatment discontinuation rates between MRA and placebo therapy were similar. Low SBP is not a reason to withhold MRA therapy in patients with HFrEF.",2020,The between-treatment difference was 2.6 (95% confidence interval [CI]: 1.5 to 3.6; p < 0.001) mm Hg.,"['patients with heart failure with reduced ejection fraction (HFrEF', 'patients with HFrEF', '4,396 patients with HFrEF randomized in the RALES (Randomized Aldactone Evaluation Study) and EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart\xa0Failure) trials']","['mineralocorticoid receptor antagonists (MRAs', 'MRA therapy', 'placebo', 'MRA', 'MRA and placebo']","['systolic blood pressure (SBP', 'Mean SBP change', 'Mineralocorticoid Receptor Antagonists, Blood Pressure, and Outcomes in Heart', 'SBP', 'Hypotension', 'hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0591054', 'cui_str': 'Aldactone'}, {'cui': 'C0015196', 'cui_str': 'Evaluation Studies'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",4396.0,0.219127,The between-treatment difference was 2.6 (95% confidence interval [CI]: 1.5 to 3.6; p < 0.001) mm Hg.,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; Cardiovascular Centre of Ferrara University, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine INSERM, CHRU de Nancy, F-CRIN INI-CRCT, Nancy France.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Centre of Ferrara University, Ferrara University, Ferrara, Italy; Gruppo Villa Maria Care & Research, Maria Cecilia Hospital, Cotignola (RA), Italy.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Internal Medicine-Cardiology, University of Michigan School of Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine INSERM, CHRU de Nancy, F-CRIN INI-CRCT, Nancy France.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine INSERM, CHRU de Nancy, F-CRIN INI-CRCT, Nancy France.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.09.011']
309,31926856,"Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone.","OBJECTIVES


This study sought to assess if clinical phenogroups differ in comprehensive biomarker profiles, cardiac and arterial structure/function, and responses to spironolactone therapy.
BACKGROUND


Previous studies identified distinct subgroups (phenogroups) of patients with heart failure with preserved ejection fraction (HFpEF).
METHODS


Among TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial) participants, we performed latent-class analysis to identify HFpEF phenogroups based on standard clinical features and assessed differences in multiple biomarkers measured from frozen plasma; cardiac and arterial structure/function measured with echocardiography and arterial tonometry; prognosis; and response to spironolactone.
RESULTS


Three HFpEF phenogroups were identified. Phenogroup 1 (n = 1,214) exhibited younger age, higher prevalence of smoking, preserved functional class, and the least evidence of left ventricular (LV) hypertrophy and arterial stiffness. Phenogroup 2 (n = 1,329) was older, with normotrophic concentric LV remodeling, atrial fibrillation, left atrial enlargement, large-artery stiffening, and biomarkers of innate immunity and vascular calcification. Phenogroup 3 (n = 899) demonstrated more functional impairment, obesity, diabetes, chronic kidney disease, concentric LV hypertrophy, high renin, and biomarkers of tumor necrosis factor-alpha-mediated inflammation, liver fibrosis, and tissue remodeling. Compared with phenogroup 1, phenogroup 3 exhibited the highest risk of the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest (hazard ratio [HR]: 3.44; 95% confidence interval [CI]: 2.79 to 4.24); phenogroups 2 and 3 demonstrated similar all-cause mortality (phenotype 2 HR: 2.36; 95% CI: 1.89 to 2.95; phenotype 3 HR: 2.26, 95% CI: 1.77 to 2.87). Spironolactone randomized therapy was associated with a more pronounced reduction in the risk of the primary endpoint in phenogroup 3 (HR: 0.75; 95% CI: 0.59 to 0.95; p for interaction = 0.016). Results were similar after excluding participants from Eastern Europe.
CONCLUSIONS


We identified important differences in circulating biomarkers, cardiac/arterial characteristics, prognosis, and response to spironolactone across clinical HFpEF phenogroups. These findings suggest distinct underlying mechanisms across clinically identifiable phenogroups of HFpEF that may benefit from different targeted interventions.",2020,"Compared with phenogroup 1, phenogroup 3 exhibited the highest risk of the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest (hazard ratio [HR]: 3.44; 95% confidence interval [CI]: 2.79 to 4.24); phenogroups 2 and 3 demonstrated similar all-cause mortality (phenotype 2 HR: 2.36; 95% CI: 1.89 to 2.95; phenotype 3 HR: 2.26, 95% CI: 1.77 to 2.87).","['1,329) was older, with normotrophic concentric LV remodeling, atrial fibrillation, left atrial enlargement, large-artery stiffening, and biomarkers of innate immunity and vascular calcification', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Heart\xa0Failure With Preserved Ejection Fraction']","['Aldosterone Antagonist Trial ', 'spironolactone therapy', 'spironolactone', 'Spironolactone']","['cardiovascular death, heart failure hospitalization, or aborted cardiac arrest', 'functional impairment, obesity, diabetes, chronic kidney disease, concentric LV hypertrophy, high renin, and biomarkers of tumor necrosis factor-alpha-mediated inflammation, liver fibrosis, and tissue remodeling', 'multiple biomarkers measured from frozen plasma; cardiac and arterial structure/function measured with echocardiography and arterial tonometry; prognosis; and response to spironolactone']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0238705', 'cui_str': 'Left atrial enlargement'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020969', 'cui_str': 'Innate Immune Response'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4318470', 'cui_str': 'Aborted'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]",1329.0,0.155881,"Compared with phenogroup 1, phenogroup 3 exhibited the highest risk of the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest (hazard ratio [HR]: 3.44; 95% confidence interval [CI]: 2.79 to 4.24); phenogroups 2 and 3 demonstrated similar all-cause mortality (phenotype 2 HR: 2.36; 95% CI: 1.89 to 2.95; phenotype 3 HR: 2.26, 95% CI: 1.77 to 2.87).","[{'ForeName': 'Jordana B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schrauben', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Basso', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Cvijic', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Yarde', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Priyanka T', 'Initials': 'PT', 'LastName': 'Bhattacharya', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Hospital Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Chirinos', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Prenner', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Zamani', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Dietmar A', 'Initials': 'DA', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Car', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gordon', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrenceville, New Jersey.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Margulies', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cappola', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.09.009']
310,31641887,Effects of sitagliptin on exercise capacity and hemodynamics in patients with type 2 diabetes mellitus and coronary artery disease.,"Sitagliptin attenuates left ventricular (LV) dysfunction and may improve oxygen uptake in animals. The effects of sitagliptin on oxygen uptake (VO 2 ) and exercise hemodynamics have been unclear in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). Thirty patients with T2DM and CAD were randomized into a sitagliptin (50 mg/day) or voglibose (0.6 mg/day) group. Patients underwent maximal cardiopulmonary exercise testing. VO 2  and hemodynamics were evaluated at rest, anaerobic threshold and peak exercise. Resting LV diastolic function (E', peak early diastolic mitral annular velocity) and geometry were evaluated by echocardiography, and endothelial function by reactive hyperemia peripheral arterial tonometry. A total of 24 patients (69 ± 9 years) completed 6 months of intervention. Peak VO 2  in the sitagliptin and voglibose groups (25.3 ± 7.3 vs. 24.0 ± 7.4, 22.7 ± 4.8 vs. 22.1 ± 5.2 ml/kg/min) was slightly decreased after 6 months (time effect p = 0.051; group × time effect p = 0.49). No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group. Heart rate during exercise was unaffected in both groups. Systolic blood pressure was unchanged by sitagliptin at rest and during exercise, but slightly lowered by voglibose at anaerobic threshold and peak exercise. In patients with T2DM and CAD, sitagliptin had little effect on resting LV and arterial function, exercise capacity, or exercise hemodynamics. Further studies need to be conducted with more patients as the number of the patients in this study was limited.",2020,"No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group.","['24 patients (69\u2009±\u20099 years) completed 6 months of intervention', 'animals', 'Thirty patients with T2DM and CAD', 'patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD', 'patients with type 2 diabetes mellitus and coronary artery disease']","['voglibose', 'sitagliptin', 'maximal cardiopulmonary exercise testing']","['Heart rate during exercise', 'Sitagliptin attenuates left ventricular (LV) dysfunction', 'resting LV and arterial function, exercise capacity, or exercise hemodynamics', 'exercise capacity and hemodynamics', 'Systolic blood pressure', 'oxygen uptake', 'VO 2  and hemodynamics', ""Resting LV diastolic function (E', peak early diastolic mitral annular velocity) and geometry were evaluated by echocardiography, and endothelial function by reactive hyperemia peripheral arterial tonometry"", 'Peak VO 2', ""LV ejection fraction, E', or reactive hyperemia index""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0532578', 'cui_str': '3,4-dideoxy-4-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-2-C-(hydroxymethyl)-D-epi-inositol'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.026279,"No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan. naokifujimo@clin.medic.mie-u.ac.jp.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Moriwaki', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Tetsushiro', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Sawai', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kumagai', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Masuda', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Nakamori', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}]",Heart and vessels,['10.1007/s00380-019-01526-7']
311,32178765,"Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Many patients with psoriatic arthritis have an inadequate response to tumor necrosis factor (TNF) inhibitors. Guselkumab, a specific inhibitor of interleukin-23 (IL-23) via IL-23 p19 subunit binding, significantly improved psoriatic arthritis signs and symptoms with an acceptable safety profile in a phase 2 trial.
METHODS


This multicentre, double-blind, randomised, placebo-controlled, phase 3 trial was done at 86 sites in 13 countries across Asia, Australasia, Europe, and North America and enrolled adults with active psoriatic arthritis (at least three swollen and three tender joints; and C-reactive protein ≥0·3 mg/dL) despite standard therapies. Eligibility criteria included inadequate response to or intolerance of standard treatment, including at least 4 months of apremilast, at least 3 months of non-biologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of non-steroidal anti-inflammatory drugs for psoriatic arthritis. About 30% of study participants could have previously received one or two TNF inhibitors. Patients were randomly assigned (1:1:1, computer-generated permuted blocks; stratified by baseline DMARD and previous TNF inhibitor use) to subcutaneous guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0, 4, then every 8 weeks; or matching placebo. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) at week 24 in all patients per assigned treatment group using non-responder imputation. Safety was assessed in all patients per treatment received. This trial is registered at ClinicalTrials.gov, NCT03162796 (active, not recruiting).
FINDINGS


From Aug 28, 2017, to Aug 17, 2018, we screened 624 patients, of whom 381 were randomly assigned and treated with guselkumab every 4 weeks (n=128), guselkumab every 8 weeks (n=127), or placebo (n=126). 362 patients continued study treatment up to week 24. The primary endpoint was met: ACR20 at week 24 was achieved by significantly greater proportions of patients in the guselkumab every 4 weeks group (76 [59%] of 128 [95% CI 50-68]) and every 8 weeks group (66 [52%] of 127 [43-61]) than in the placebo group (28 [22%] of 126 [15-30]), with percentage differences versus placebo of 37% (95% CI 26-48) for the every 4 weeks group and 30% (19-41) for the every 8 weeks group (both p<0·0001). Serious adverse events up to week 24 occurred in no patients receiving guselkumab every 4 weeks, four (3%) patients receiving guselkumab every 8 weeks, and five (4%) patients receiving placebo. Up to week 24, one patient in the placebo group died from cardiac failure and two had serious infections; no guselkumab-treated patient died or had serious infections.
INTERPRETATION


Guselkumab demonstrated a favourable benefit-risk profile and might be an effective treatment option for patients with active psoriatic arthritis.
FUNDING


Janssen Research and Development.",2020,"ACR20 at week 24 was achieved by significantly greater proportions of patients in the guselkumab every 4 weeks group (76 [59%] of 128 [95% CI 50-68]) and every 8 weeks group (66 [52%] of 127 [43-61]) than in the placebo group (28 [22%] of 126 [15-30]), with percentage differences versus placebo of 37% (95% CI 26-48) for the every 4 weeks group and 30% (19-41) for the every 8 weeks group (both p<0·0001).","['86 sites in 13 countries across Asia, Australasia, Europe, and North America and enrolled adults with active psoriatic arthritis (at least three swollen and three tender joints; and C-reactive protein ≥0·3 mg/dL) despite standard therapies', '362 patients continued study treatment up to week 24', 'patients with active psoriatic arthritis', 'patients with psoriatic arthritis', 'From Aug 28, 2017, to Aug 17, 2018, we screened 624 patients', 'Eligibility criteria included inadequate response to or intolerance of standard treatment, including at least 4 months of apremilast, at least 3 months of non-biologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of non-steroidal anti-inflammatory drugs for psoriatic arthritis', 'patients with active psoriatic arthritis who were biologic-naive or had previously received']","['computer-generated permuted blocks; stratified by baseline DMARD and previous TNF inhibitor use) to subcutaneous guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0, 4, then every 8 weeks; or matching placebo', 'guselkumab', 'TNFα inhibitor treatment', 'Guselkumab', 'placebo']","['serious infections; no guselkumab-treated patient died or had serious infections', 'Serious adverse events', 'ACR20', 'Safety', 'cardiac failure', 'American College of Rheumatology 20% improvement (ACR20']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0282279', 'cui_str': 'Oceania'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",362.0,0.71094,"ACR20 at week 24 was achieved by significantly greater proportions of patients in the guselkumab every 4 weeks group (76 [59%] of 128 [95% CI 50-68]) and every 8 weeks group (66 [52%] of 127 [43-61]) than in the placebo group (28 [22%] of 126 [15-30]), with percentage differences versus placebo of 37% (95% CI 26-48) for the every 4 weeks group and 30% (19-41) for the every 8 weeks group (both p<0·0001).","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA. Electronic address: deodhara@ohsu.edu.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; National Institute for Health Research Leeds Musculoskeletal Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venerology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Immunology, Janssen Research and Development, Spring House, PA, USA; University of Pennsylvania Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Ramanand A', 'Initials': 'RA', 'LastName': 'Subramanian', 'Affiliation': 'Immunology, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': 'Allergy, Immunology, and Rheumatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30265-8']
312,32178766,"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


The interleukin-23 (IL-23)/T-helper 17 cell pathway is implicated in psoriatic arthritis pathogenesis. Guselkumab, an IL-23 inhibitor that specifically binds the IL-23 p19 subunit, significantly and safely improved psoriatic arthritis in a phase 2 study. DISCOVER-2 was a phase 3 trial to assess guselkumab in biologic-naive patients with psoriatic arthritis.
METHODS


This phase 3, double-blind, placebo-controlled study was done at 118 sites in 13 countries across Asia, Europe, and North America. We enrolled biologic-naive patients with active psoriatic arthritis (at least five swollen joints, at least five tender joints, and C-reactive protein ≥0·6 mg/dL) despite standard therapies. Patients were randomly assigned (1:1:1, computer-generated permuted blocks; stratified by baseline disease-modifying antirheumatic drug use and C-reactive protein concentration) to subcutaneous injections of guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0, 4, then every 8 weeks; or placebo. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) response at week 24 in all patients per assigned treatment group. Safety was assessed in all patients per treatment received. This trial is registered at ClinicalTrials.gov, NCT03158285 (active, not recruiting).
FINDINGS


From July 13, 2017, to Aug 3, 2018, 1153 patients were screened, of whom 741 were randomly assigned to receive guselkumab every 4 weeks (n=246), every 8 weeks (n=248), or placebo (n=247). One patient in the every 4 weeks group and one in the placebo group did not start treatment, and the remaining 739 patients started treatment; 716 patients continued treatment up to week 24. Significantly greater proportions of patients in the guselkumab every 4 weeks group (156 [64%] of 245 [95% CI 57-70]) and every 8 weeks group (159 [64%] of 248 [58-70]) than in the placebo group (81 [33%] of 246 [27-39]) achieved an ACR20 response at week 24 (percentage differences vs placebo 31% [95% CI 22-39] for the every 4 weeks group and 31% [23-40] for the every 8 weeks group; both p<0·0001). Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection). No deaths occurred.
INTERPRETATION


Guselkumab, a human monoclonal antibody that specifically inhibits IL-23 by binding the cytokine's p19 subunit, was efficacious and demonstrated an acceptable benefit-risk profile in patients with active psoriatic arthritis who were naive to treatment with biologics. These data support the use of selective inhibition of IL-23 to treat psoriatic arthritis.
FUNDING


Janssen Research and Development.",2020,"Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection).","['118 sites in 13 countries across Asia, Europe, and North America', 'biologic-naive patients with psoriatic arthritis', 'biologic-naive patients with active psoriatic arthritis (DISCOVER-2', 'From July 13, 2017, to Aug 3, 2018, 1153 patients were screened, of whom 741', 'patients with active psoriatic arthritis who were naive to treatment with biologics', 'enrolled biologic-naive patients with active psoriatic arthritis (at least five swollen joints, at least five tender joints, and C-reactive protein ≥0·6 mg/dL) despite standard therapies']","['guselkumab 100 mg every 4 weeks; guselkumab', 'Guselkumab', 'guselkumab', 'placebo']","['psoriatic arthritis', 'ACR20 response', 'serious adverse events', 'American College of Rheumatology 20% improvement (ACR20) response', 'Safety']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1153.0,0.608705,"Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection).","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Department of Rheumatology, Swedish Medical Center, Providence St Joseph Health and University of Washington, Seattle, WA, USA. Electronic address: pmease@philipmease.com.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Department of Rheumatology, Memorial University of Newfoundland, St Johns, NL, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Immunology, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Division of Immunology, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30263-4']
313,30578651,Manipulation of mechanical ventilatory constraint during moderate intensity exercise does not influence dyspnoea in healthy older men and women.,"KEY POINTS


The perceived intensity of exertional breathlessness (i.e. dyspnoea) is higher in older women than in older men, possibly as a result of sex-differences in respiratory system morphology. During exercise at a given absolute intensity or minute ventilation, older women have a greater degree of mechanical ventilatory constraint (i.e. work of breathing and expiratory flow limitation) than their male counterparts, which may lead to a greater perceived intensity of dyspnoea. Using a single-blind randomized study design, we experimentally manipulated the magnitude of mechanical ventilatory constraint during moderate-intensity exercise at ventilatory threshold in healthy older men and women. We found that changes in the magnitude of mechanical ventilatory constraint within the physiological range had no effect on dyspnoea in healthy older adults. When older men and women perform moderate intensity exercise, mechanical ventilatory constraint does not contribute significantly to the sensation of dyspnoea.
ABSTRACT


We aimed to determine the effect of manipulating mechanical ventilatory constraint during submaximal exercise on dyspnoea in older men and women. Eighteen healthy subjects (aged 60-80 years; nine men and nine women) completed two days of testing. On day 1, subjects were assessed for pulmonary function and performed a maximal incremental cycle exercise test. On day 2, subjects performed three 6-min bouts of cycling at ventilatory threshold, in a single-blind randomized manner, while breathing: (i) normoxic helium-oxygen (HEL) to reduce the work of breathing (W b  ) and alleviate expiratory flow limitation (EFL); (ii) through an inspiratory resistance (RES) of ∼5 cmH 2  O L -1   s -1  to increase W b  ; and (iii) ambient air as a control (CON). Oesophageal pressure, diaphragm electromyography, and sensory responses (category-ratio 10 Borg scale) were monitored throughout exercise. During the HEL condition, there was a significant decrease in W b  (men: -21 ± 6%, women: -17 ± 10%) relative to CON (both P < 0.01). Moreover, if EFL was present during CON (four men and five women), it was alleviated during HEL. Conversely, during the RES condition, W b  (men: 42 ± 19%, women: 50 ± 16%) significantly increased relative to CON (both P < 0.01). There was no main effect of sex on W b  (P = 0.59). Across conditions, women reported significantly higher dyspnoea intensity than men (2.9 ± 0.9 vs. 1.9 ± 0.8 Borg scale units, P < 0.05). Despite significant differences in the degree of mechanical ventilatory constraint between conditions, the intensity of dyspnoea was unaffected, independent of sex (P = 0.46). When older men and women perform moderate intensity exercise, mechanical ventilatory constraint does not contribute significantly to the sensation of dyspnoea.",2019,"Despite significant differences in the degree of mechanical ventilatory constraint between conditions, the intensity of dyspnoea was unaffected, independent of sex (P = 0.46).","['healthy older men and women', 'Eighteen healthy subjects (aged 60-80\xa0years; nine men and nine women', 'healthy older adults', 'older men and women', '±\xa06%, women', 'men']","['mechanical ventilatory constraint during moderate intensity exercise', 'mechanical ventilatory constraint during moderate-intensity exercise', 'EFL', 'mechanical ventilatory constraint during submaximal exercise', 'O\xa0L -1', '6-min bouts of cycling at ventilatory threshold, in a single-blind randomized manner, while breathing: (i) normoxic helium-oxygen (HEL) to reduce the work of breathing (W b  ) and alleviate expiratory flow limitation (EFL); (ii) through an inspiratory resistance (RES) of ∼5 cmH 2']","['W b', 'dyspnoea intensity', 'sensation of dyspnoea', 'relative to CON', 'intensity of dyspnoea', 'Oesophageal pressure, diaphragm electromyography, and sensory responses (category-ratio 10 Borg scale', 'exertional breathlessness (i.e. dyspnoea', 'dyspnoea']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}]",18.0,0.0273277,"Despite significant differences in the degree of mechanical ventilatory constraint between conditions, the intensity of dyspnoea was unaffected, independent of sex (P = 0.46).","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Molgat-Seon', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': ""Centre for Heart Lung Innovation, St Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Carli M', 'Initials': 'CM', 'LastName': 'Peters', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Schaeffer', 'Affiliation': ""Centre for Heart Lung Innovation, St Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Dominelli', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Romer', 'Affiliation': 'Centre for Human Performance, Exercise and Rehabilitation, College of Health and Life Sciences, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Road', 'Affiliation': 'Division of Respiratory Medicine, Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}]",The Journal of physiology,['10.1113/JP277476']
314,31169651,Bilateral subcostal transversus abdominis plane block does not improve the postoperative analgesia provided by multimodal analgesia after laparoscopic cholecystectomy: A randomised placebo-controlled trial.,"BACKGROUND


Laparoscopic cholecystectomy might be considered minor surgery, but it may result in severe postoperative pain. Subcostal transversus abdominis plane (TAP) block, which produces long-lasting supra-umbilical parietal analgesia, might improve analgesia after laparoscopic cholecystectomy.
OBJECTIVE


We investigated whether subcostal TAP block would reduce opioid consumption and pain after laparoscopic cholecystectomy in patients provided with multimodal analgesia.
DESIGN


A randomised, placebo-controlled, double-blind study.
SETTING


The study was conducted at a university teaching hospital from December 2017 to June 2018.
PATIENTS


Sixty patients scheduled for laparoscopic cholecystectomy were included. Anaesthesia and postoperative analgesia (etoricoxib, paracetamol, ketamine and dexamethasone) were standardised.
INTERVENTION


After induction of anaesthesia, patients were allocated into two groups: ultrasound-guided bilateral subcostal TAP block with 20 ml of levobupivacaine 0.375% and epinephrine 5 μg ml or 0.9% saline with epinephrine 5 μg ml.
MAIN OUTCOME MEASURES


Opioid consumption in the recovery room and during the first 24 h after surgery were recorded. Postoperative somatic and visceral pain scores, fatigue and nausea were measured. Intra-operative end-tidal concentrations of sevoflurane (FETSEVO) were also recorded.
RESULTS


Twenty-four hour postoperative opioid consumption were similar in both groups: 21.2 mg (95% CI 15.3 to 27.1) vs. 25.2 (95% CI 15.1 to 35.5) oral morphine equivalent in the levobupivacaine and 0.9% saline groups, respectively; P = 0.48. No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea. FETSEVO was slightly lower in the levobupivacaine group (P < 0.01).
CONCLUSION


Subcostal TAP block does not improve the analgesia provided by multimodal analgesia after laparoscopic cholecystectomy. It allows for a small reduction in intra-operative sevoflurane requirements.
TRIAL REGISTRATION


NCT0339153.",2019,"No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea.","['Sixty patients scheduled for', 'The study was conducted at a university teaching hospital from December 2017 to June 2018', 'patients provided with multimodal analgesia']","['Bilateral subcostal transversus abdominis plane block', 'placebo', 'sevoflurane (FETSEVO', 'levobupivacaine', 'subcostal TAP block', 'laparoscopic cholecystectomy', 'Subcostal transversus abdominis plane (TAP) block', 'Laparoscopic cholecystectomy', 'Anaesthesia and postoperative analgesia (etoricoxib, paracetamol, ketamine and dexamethasone', 'ultrasound-guided bilateral subcostal TAP block with 20\u200aml of levobupivacaine 0.375% and epinephrine 5\u200aμg\u200aml or 0.9% saline with epinephrine 5\u200aμg\u200aml', 'Subcostal TAP block']","['postoperative opioid consumption', 'Opioid consumption in the recovery room and during the first 24\u200ah after surgery', 'pain scores, fatigue and nausea', 'opioid consumption and pain', 'Postoperative somatic and visceral pain scores, fatigue and nausea']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234245', 'cui_str': 'Visceral Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.590609,"No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea.","[{'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Houben', 'Affiliation': 'From the Department of Anaesthesiology (AMH, A-SJM, AK, JLJ), Service of Abdominal Surgery, CHU Liège, University of Liège, Domaine du Sart Tilman, Liège, Belgium (OMD).'}, {'ForeName': 'Anne-Sophie J', 'Initials': 'AJ', 'LastName': 'Moreau', 'Affiliation': ''}, {'ForeName': 'Olivier M', 'Initials': 'OM', 'LastName': 'Detry', 'Affiliation': ''}, {'ForeName': 'Abdourahamane', 'Initials': 'A', 'LastName': 'Kaba', 'Affiliation': ''}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Joris', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001028']
315,31361631,Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study.,"BACKGROUND


Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative.
OBJECTIVES


The aim of this study was to compare the efficacy of SCB vs. ISB in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR), with the hypothesis of noninferiority of SCB analgesia compared with ISB.
DESIGN


A randomised, single-blind, noninferiority study.
SETTING


Hôpital Privé Jean Mermoz, Centre Paul Santy, Lyon, France.
PATIENTS


Ambulatory ARCR patients.
INTERVENTION


Patients were randomly allocated (1 : 1) to receive a single injection SCB or ISB, as well as general anaesthesia. All patients received a postoperative analgesic prescription for home use before leaving hospital (including fast-acting oral morphine sulphate). Patients completed a telephone questionnaire on days 1 and 2 postsurgery.
MAIN OUTCOME MEASURES


Primary endpoint was oral morphine consumption (mg) during the first 2 days postsurgery. If the difference between mean morphine consumption in the SCB vs. ISB group was less than 30 mg, noninferiority of SCB compared with ISB would be demonstrated. Secondary evaluation criteria included pain scores (numerical rating scale), duration of motor and sensory blockade, and satisfaction with treatment.
RESULTS


The per-protocol cohort included 103 patients (SCB = 52, ISB = 51) (57% men, median age 58 years). Mean morphine consumption in the 48 h postsurgery was 9.4 vs. 14.7 mg in the SCB and ISB groups, respectively (difference -5.3, P < 0.001). The upper limit of the 95% CI was less than 30 mg, demonstrating noninferiority of SCB compared with ISB. No difference was observed between the two groups in terms of pain scores or the duration of motor or sensory blockade. Overall, 98% of patients in the SCB group vs. 90% in the ISB group were satisfied with their treatment.
CONCLUSION


SCB is as effective as ISB in terms of postoperative analgesia based on oral morphine consumption in patients undergoing ambulatory ARCR.
TRIAL REGISTRATION


EudraCT number: 2016-A00747-47.",2019,"Mean morphine consumption in the 48 h postsurgery was 9.4 vs. 14.7 mg in the SCB and ISB groups, respectively (difference -5.3, P < 0.001).","['ambulatory arthroscopic rotator cuff repair', 'patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR', 'patients undergoing ambulatory ARCR', 'Hôpital Privé Jean Mermoz, Centre Paul Santy, Lyon, France', '103 patients (SCB\u200a=\u200a52, ISB\u200a=\u200a51) (57% men, median age 58 years', 'Ambulatory ARCR patients']","['ultrasound-guided interscalene block vs. supraclavicular block', 'ISB', 'telephone questionnaire', 'Ultrasound-guided interscalene block (ISB', 'single injection SCB or ISB', 'postoperative analgesic prescription for home use before leaving hospital (including fast-acting oral morphine sulphate', 'SCB', 'SCB vs. ISB']","['mean morphine consumption', 'pain scores or the duration of motor or sensory blockade', 'Mean morphine consumption', 'pain scores (numerical rating scale), duration of motor and sensory blockade, and satisfaction with treatment', 'Analgesic efficacy', 'oral morphine consumption']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0453932', 'cui_str': 'Jeans (physical object)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",103.0,0.139869,"Mean morphine consumption in the 48 h postsurgery was 9.4 vs. 14.7 mg in the SCB and ISB groups, respectively (difference -5.3, P < 0.001).","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Cabaton', 'Affiliation': 'From the Department of Anaesthesiology (JC, TV), Department of Shoulder Surgery, Ramsay Générale de Santé - Hôpital Privé Jean Mermoz, Centre Paul Santy (LN-J), and Department of Anaesthesiology, Ramsay Générale de Santé - Hôpital Privé Claude Galien, Quincy-Sous-Sénard, France (LM).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Nové-Josserand', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mercadal', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Vaudelin', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001065']
316,31742932,Comparison of steroid-releasing stents vs nonabsorbable packing as middle meatal spacers.,"BACKGROUND


A randomized controlled trial was held to compare nonabsorbable packs to steroid-eluting absorbable stents as middle meatal spacers after endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS).
METHODS


CRS patients were randomly assigned to receive either nonabsorbable Merocel packs wrapped in non-latex glove material (packing type A) or Propel steroid eluting stents (packing type B). Twenty-two-item Sino-Nasal Outcome Test (SNOT-22) scores were collected preoperatively and postoperatively during the initial 4 debridements up to 3 months. Recording of the nasal endoscopy was also collected during all postoperative visits. In addition, Lund-Kennedy scores and middle turbinate lateralization scores, using a new visual analogue scale, were compared between the 2 types of packing.
RESULTS


Forty CRS patients were prospectively enrolled in this institutional review board (IRB)-approved study. Patients with packing type A had significantly lower middle turbinate lateralization scores at their first (∼10 days) postoperative visit (p = 0.02 and p = 0.04, for left and right sides, respectively). This difference disappeared by later postoperative visits (from 20 days to 3 months). Overall, patients receiving packing type A had significant lower SNOT-22 scores at 20 days postsurgery (p = 0.05). This difference also disappeared at 1 and 3 months postoperation. There were no statistically significant differences in Lund-Kennedy scores.
CONCLUSION


In this study, nonabsorbable packing materials showed significant superior middle meatal spacing capacities as evidenced by greater middle turbinate medialization capability at the first postoperative visit. Additionally, patients with this type of packing saw improvements in their SNOT-22 scores at the 20-day postoperative visit. This study showed that there was no significant improvement in postoperative outcomes with drug-eluting stents when compared to nonabsorbable packing.",2020,Patients with packing type A had significantly lower middle turbinate lateralization scores at their first (∼10 days) postoperative visit,"['patients with chronic rhinosinusitis (CRS', 'CRS patients', 'Forty CRS patients']","['nonabsorbable Merocel packs wrapped in non-latex glove material (packing type A) or Propel steroid eluting stents (packing type B', 'nonabsorbable packs to steroid-eluting absorbable stents', 'steroid-releasing stents vs nonabsorbable packing']","['middle turbinate lateralization scores', 'Lund-Kennedy scores', 'postoperative outcomes', 'new visual analogue scale', 'SNOT-22 scores', 'superior middle meatal spacing capacities', 'Lund-Kennedy scores and middle turbinate lateralization scores', 'postoperative visit', 'middle turbinate medialization capability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}]","[{'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3204590', 'cui_str': 'Propel'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}]",40.0,0.0413188,Patients with packing type A had significantly lower middle turbinate lateralization scores at their first (∼10 days) postoperative visit,"[{'ForeName': 'Jordan W', 'Initials': 'JW', 'LastName': 'Rawl', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'McQuitty', 'Affiliation': 'University of Texas Medical Branch School of Medicine, Galveston, TX.'}, {'ForeName': 'Mashfee H', 'Initials': 'MH', 'LastName': 'Khan', 'Affiliation': 'University of Texas Medical Branch School of Medicine, Galveston, TX.'}, {'ForeName': 'Lara K', 'Initials': 'LK', 'LastName': 'Reichert', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Yong-Fang', 'Initials': 'YF', 'LastName': 'Kuo', 'Affiliation': 'Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Mohamad R', 'Initials': 'MR', 'LastName': 'Chaaban', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Texas Medical Branch, Galveston, TX.'}]",International forum of allergy & rhinology,['10.1002/alr.22492']
317,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2020,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
318,32266572,Near Infrared (NIR) Fluorescence is Not a Substitute for Lymphoscintigraphy and Gamma Probe for Melanoma Sentinel Node Detection: Results from a Prospective Trial.,"BACKGROUND


Sentinel lymph node (SLN) biopsy is the standard care for early detection and staging of lymph node metastasis in melanomas. Radiocolloids (RC) and blue dyes are used for SLN detection. Recently, near infrared (NIR) fluorescence tracing using indocyanine green has been developed as an alternative method for SLN detection. The relatively high tissue penetration depth of several millimeters and the ability to detect low concentrations of tracer both suggest that NIR may have significant advantages over RC and the blue dye methods. The objective of this study was to prospectively compare the performance of all three SLN detection techniques using them sequentially to evaluate the same group of patients.
METHODS


One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy were assigned to the procedure following NIR, blue dye, and RC detection techniques.
RESULTS


No adverse event was reported. SLN was not detected in only 4.1% of cases. In 90.9%, an SLN was identified with NIR, but without any auxiliary technique in only 70.2% of cases. RC detected the SLN in 92.6% of cases. Patent blue was found in the sentinel node in 76.9%. The combination of all three techniques detected an SLN in 95.9% of cases. Metastases were present in 26.7%. The false-negative rate was 8.8%, with a negative predictive value of 91.2%.
CONCLUSIONS


RC was the only technique with high SLN detection. Both the blue dye and NIR methods added sensitivity to the detection rate but should not be a substitute for RC.",2020,No adverse event was reported.,"['One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy', 'Melanoma Sentinel Node Detection']","['procedure following NIR, blue dye, and RC detection techniques']","['SLN', 'false-negative rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",121.0,0.0539327,No adverse event was reported.,"[{'ForeName': 'Carlos Eduardo Barbosa', 'Initials': 'CEB', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Capuzzo', 'Affiliation': 'Department of Head and Neck, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Crovador', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renan J', 'Initials': 'RJ', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Laus', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Andre Lopes', 'Initials': 'AL', 'LastName': 'Carvalho', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Vinicius L', 'Initials': 'VL', 'LastName': 'Vazquez', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil. viniciusvazquez@gmail.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-08409-6']
319,32279106,A comparison of endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty for repairing medium- to large-sized tympanic membrane perforation: a randomized clinical trial.,"INTRODUCTION


Endoscopic type I tympanoplasty (ETT) is currently accepted as an effective, minimally traumatic procedure for repairing tympanic membrane perforation. However, ETT requires tympanomeatal flap elevation which chorda tympani nerve injury, bleeding and wound healing are the drawbacks of this technique. Thus endoscopic transtympanic myringoplasty (ETM) without elevation of the tympanomeatal flap is commonly used as an alternative technique. This study aimed to compare the efficacy of ETM versus ETT for repairing medium- to large-sized perforation of the tympanic membrane.
METHODS


The study cohort comprised patients undergoing surgery for medium- to large-sized perforation of the tympanic membrane between February 2018 and February 2019. The patients were randomized into the ETM group and the ETT group. The main outcomes were the graft take rates and hearing results. Secondary outcomes were the operative time, visual analog scale (VAS) pain scores, and postoperative complications.
RESULTS


Forty patients who completed 6 months of follow-up were included, comprising 21 patients in the ETM group and 19 in the ETT group. The overall graft take rates for the ETM and ETT groups were 95.2% and 89.5%, respectively (P = 0.59). The graft take rates for patients in the ETM group with large-sized tympanic membrane perforation was 88.9%. There was a significantly higher rate of good hearing result in the ETM group (95.2% versus 68.4%) (P = 0.04). The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
CONCLUSION


Our results demonstrated that the surgical outcome of ETM is comparable to that of ETT. However, ETM is less invasive and has a shorter operative time than ETT, and is suitable for simple perforation repair, regardless of the perforation size.",2020,"The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
","['Forty patients who completed 6\xa0months of follow-up were included, comprising 21 patients in the ETM group and 19 in the ETT group', 'patients undergoing surgery for medium- to large-sized perforation of the tympanic membrane between February 2018 and February 2019', 'repairing medium- to large-sized tympanic membrane perforation']","['Endoscopic type I tympanoplasty (ETT', 'ETM versus ETT', 'ETM', 'endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty']","['rate of good hearing result', 'shorter operative times', 'graft take rates and hearing results', 'operative time, visual analog scale (VAS) pain scores, and postoperative complications', 'graft take rates', 'overall graft take rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",21.0,0.0648849,"The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
","[{'ForeName': 'Viraporn', 'Initials': 'V', 'LastName': 'Atchariyasathian', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand. viraporn.a@psu.ac.th.'}, {'ForeName': 'Rata', 'Initials': 'R', 'LastName': 'Suwannajak', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}, {'ForeName': 'Yuvatiya', 'Initials': 'Y', 'LastName': 'Plodpai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}, {'ForeName': 'Pittayapon', 'Initials': 'P', 'LastName': 'Pitathawatchai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05955-3']
320,32279123,The immediate effect of stroboscopic visual training on information-processing time in people with multiple sclerosis: an exploratory study.,"Stroboscopic visual training (SVT) is a form of training aimed at improving visual and perceptual performance by having individuals perform activities under conditions of intermittent vision. The efficacy of SVT has never been examined in people with multiple sclerosis (PwMS), therefore, our aim was to examine the immediate effect of SVT on cognitive function, gait and static balance performance in PwMS. This assessor-blinded, randomized crossover study included 26 PwMS, 16 females, mean age 47.9 and median EDSS score 4.5. Participants attended two sessions: SVT and control training. Exercises for both the SVT and control sessions were based on ball-catching tasks. Training sessions were identical in length (40-50 min) and type of exercise drills. The difference between the two practice regimes was that the SVT session was performed wearing stroboscopic glasses and the control training was performed with similar glasses without lenses. Cognition was evaluated by a computerized software (Mindstreams ® , NeuroTrax Corp., NY). Gait and balance were evaluated via wearable accelerometers (APDM, Oregon, USA). Outcome measures were collected twice during a single session, prior to training and immediately afterward. Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session. No differences between pre-post evaluations were observed for other cognitive scores following the SVT session. No differences between pre-post measurements were noted for gait and balance following the SVT session. The present study's results justify performing future RCT studies to examine the effects of a longer SVT program on cognition in PwMS.",2020,"Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session.","['people with multiple sclerosis', '26 PwMS, 16 females, mean age 47.9 and median EDSS score 4.5', 'people with multiple sclerosis (PwMS']","['SVT and control training', 'stroboscopic visual training', 'SVT program', 'SVT', 'Stroboscopic visual training (SVT']","['Information processing speed', 'cognitive scores', 'gait and balance', 'Gait and balance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0355267,"Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session.","[{'ForeName': 'Nov', 'Initials': 'N', 'LastName': 'Shalmoni', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kalron', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. alonkalr@post.tau.ac.il.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02190-2']
321,31652094,Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.,"PURPOSE


Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.
METHODS


We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.
RESULTS


One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  P  = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide.
CONCLUSION


Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.",2020,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  ","['Smoldering Multiple Myeloma', 'patients with intermediate- or high-risk smoldering multiple myeloma', 'One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm']","['single-agent lenalidomide', 'lenalidomide', 'Lenalidomide']","['progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression', '3-year progression-free survival', 'Progression-free survival', 'Grade 3 or 4 nonhematologic adverse events']","[{'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",182.0,0.116764,"Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;  ","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jacobus', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare Cancer Center, Appleton, WI.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Abdulraheem M', 'Initials': 'AM', 'LastName': 'Yacoub', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Francis K', 'Initials': 'FK', 'LastName': 'Buadi', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Matous', 'Affiliation': 'Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Park Nicollet Clinic, Saint Louis Park, MN.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Emmons', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Mahindra', 'Affiliation': 'Scripps Clinic Torrey Pines, La Jolla, CA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC.'}, {'ForeName': 'Madhav V', 'Initials': 'MV', 'LastName': 'Dhodapkar', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01740']
322,32196462,A Mobile Health Intervention for Mental Health Promotion Among University Students: Randomized Controlled Trial.,"BACKGROUND


High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one's community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population.
OBJECTIVE


The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design.
METHODS


A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants' mobile phones.
RESULTS


A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables.
CONCLUSIONS


The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632.",2020,"For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002).","['University Students', 'Mental Health Promotion', '654 participants (median age 25 years), including 510 (78.0%) identifying as female', 'Participants were recruited using digital advertising through student health care centers in Sweden', 'Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone', 'Swedish university students', 'university students']","['Mobile health (mHealth) interventions', 'mHealth positive psychology program intervention', 'fully automated mHealth intervention']","['positive mental health (MHC-SF', 'positive mental health', 'depression and anxiety symptomatology', 'depressive and anxiety symptoms', 'positive mental health, and anxiety and depression symptomology', 'Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology', 'subscales of MHC-SF', 'depression and anxiety symptomatology (HADS', 'Hospital Anxiety Depression Scale (HADS']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0586740', 'cui_str': 'Able to read (finding)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0222045'}]",654.0,0.231904,"For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002).","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Müssener', 'Affiliation': 'Linköping University, Linköping, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Linderoth', 'Affiliation': 'Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Linköping University, Linköping, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/17208']
323,30628073,Carotid chemoreflex activity restrains post-exercise cardiac autonomic control in healthy humans and in patients with pulmonary arterial hypertension.,"KEY POINTS


Dysfunction of post-exercise cardiac autonomic control is associated with increased mortality risk in healthy adults and in patients with cardiorespiratory diseases. The afferent mechanisms that regulate the post-exercise cardiac autonomic control remain unclear. We found that afferent signals from carotid chemoreceptors restrain the post-exercise cardiac autonomic control in healthy adults and patients with pulmonary arterial hypertension (PAH). Patients with PAH had higher carotid chemoreflex sensitivity, and the magnitude of carotid chemoreceptor restraint of autonomic control was greater in patients with PAH as compared to healthy adults. The results demonstrate that the carotid chemoreceptors contribute to the regulation of post-exercise cardiac autonomic control, and suggest that the carotid chemoreceptors may be a potential target to treat post-exercise cardiac autonomic dysfunction in patients with PAH.
ABSTRACT


Dysfunction of post-exercise cardiac autonomic control predicts mortality, but its underlying mechanisms remain unclear. We tested whether carotid chemoreflex activity restrains post-exercise cardiac autonomic control in healthy adults (HA), and whether such restraint is greater in patients with pulmonary arterial hypertension (PAH) who may have both altered carotid chemoreflex and altered post-exercise cardiac autonomic control. Twenty non-hypoxaemic patients with PAH and 13 age- and sex-matched HA pedalled until 90% of peak work rate observed in a symptom-limited ramp-incremental exercise test. Recovery consisted of unloaded pedalling for 5 min followed by seated rest for 6 min. During recovery, subjects randomly inhaled either 100% O 2  (hyperoxia) to inhibit the carotid chemoreceptor activity, or 21% O 2  (normoxia) as control. Post-exercise cardiac autonomic control was examined via heart rate (HR) recovery (HRR; HR change after 30, 60, 120 and 300 s of recovery, using linear and non-linear regressions of HR decay) and HR variability (HRV; time and spectral domain analyses). As expected, the PAH group had higher carotid chemosensitivity and worse post-exercise HRR and HRV than HA. Hyperoxia increased HRR at 30, 60 and 120 s and absolute spectral power HRV in both groups. Additionally, hyperoxia resulted in an accelerated linear HR decay and increased time domain HRV during active recovery only in the PAH group. In conclusion, the carotid chemoreceptors restrained recovery of cardiac autonomic control from exercise in HA and in patients with PAH, with the restraint greater for some autonomic indexes in patients with PAH.",2019,"Patients with PAH had higher carotid chemoreflex sensitivity, and the magnitude of carotid chemoreceptor restraint of autonomic control was greater in patients with PAH as compared to healthy adults.","['healthy humans and in patients with pulmonary arterial hypertension', 'Twenty non-hypoxaemic patients with PAH and 13 age- and sex-matched HA pedalled until 90% of peak work rate observed in a symptom-limited ramp-incremental exercise test', 'patients with PAH', 'healthy adults (HA', 'healthy adults and in patients with cardiorespiratory diseases', 'healthy adults and patients with pulmonary arterial hypertension (PAH', 'patients with pulmonary arterial hypertension (PAH) who may have both altered carotid chemoreflex and altered post-exercise cardiac autonomic control']","['Carotid chemoreflex activity restrains post-exercise cardiac autonomic control', 'carotid chemoreflex activity restrains post-exercise cardiac autonomic control', 'unloaded pedalling for 5\xa0min followed by seated rest for 6\xa0min']","['carotid chemoreceptor restraint of autonomic control', 'heart rate (HR) recovery (HRR; HR change', 'mortality risk', 'HR variability (HRV; time and spectral domain analyses', 'carotid chemoreflex sensitivity', 'carotid chemosensitivity', 'time domain HRV', 'Hyperoxia increased HRR', 'accelerated linear HR decay']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}]",,0.0468172,"Patients with PAH had higher carotid chemoreflex sensitivity, and the magnitude of carotid chemoreceptor restraint of autonomic control was greater in patients with PAH as compared to healthy adults.","[{'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Paula-Ribeiro', 'Affiliation': 'Post-graduate Program in Translational Medicine, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Indyanara C', 'Initials': 'IC', 'LastName': 'Ribeiro', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Liliane C', 'Initials': 'LC', 'LastName': 'Aranda', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Talita M', 'Initials': 'TM', 'LastName': 'Silva', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila M', 'Initials': 'CM', 'LastName': 'Costa', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Roberta P', 'Initials': 'RP', 'LastName': 'Ramos', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Jaquelina S', 'Initials': 'JS', 'LastName': 'Ota-Arakaki', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Cravo', 'Affiliation': 'Department of Physiology, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Luiz E', 'Initials': 'LE', 'LastName': 'Nery', 'Affiliation': 'Pulmonary Vascular Group and Pulmonary Function and Clinical Exercise Physiology Unit, Division of Respiratory Diseases, Department of Medicine, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Silva', 'Affiliation': 'Post-graduate Program in Translational Medicine, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]",The Journal of physiology,['10.1113/JP277190']
324,31415305,The distance between the glottis and the cuff of a tracheal tube placed through three supraglottic airway devices in children: A randomised controlled trial.,"BACKGROUND


After tracheal tube insertion via various types of supraglottic airway devices, the distance from the tube cuff to the vocal cords has not been evaluated in children.
OBJECTIVES


The aim of this study was to evaluate the position of a tracheal tube cuff relative to the glottis in children when one of three supraglottic airway devices (I-gel, AuraGain and air-Q laryngeal airway) are used as intubation conduits.
DESIGN


A randomised controlled trial.
SETTING


Tertiary children's hospital.
PATIENTS


Children aged less than 7 years.
INTERVENTION


In vivo fibre-optic assessment and in vitro measurement.
MAIN OUTCOME MEASURES


The main outcome was the safety margin: the distance between the ventilation outlet of the supraglottic airway device and the beginning of the proximal cuff minus that from the ventilation outlet to the glottis. The maximum inner diameter of the cuffed tracheal tube that could be inserted, the fibre-optic view score and the oropharyngeal leak pressure were also evaluated.
RESULTS


The three devices exhibited significant differences in the distance from the ventilation outlet to the glottis (mean ± SD): I-gel 3.6 ± 0.6 cm, AuraGain 3.8 ± 0.7 cm, air-Q 2.8 ± 1.0 cm (P < 0.001). The safety margin was greatest with the air-Q and narrowest with the I-gel: I gel 1.9 ± 1.1 cm, AuraGain 4.4 ± 0.7 cm and air-Q 7.9 ± 1.1 cm. Using the AuraGain and air-Q, the cuffs of the tracheal tubes were predicted to be located below the glottis with one-size and two-size smaller tracheal tubes in all patients. However, using I-gel, the cuffs would be below the glottis in 69% (95% CI 49.6 to 84.5) and 29% (95% CI 14.0 to 48.4) of the patients with a one-size and two-size smaller tube, respectively.
CONCLUSION


The AuraGain and air-Q are well tolerated intubating conduits. The possibility of vocal cord damage is higher when the I-gel is used.
TRIAL REGISTRATION


www.clinicaltrials.gov (number: NCT03156166).",2019,The three devices exhibited significant differences in the distance from the ventilation outlet to the glottis (mean ± SD),"['children', ""Tertiary children's hospital"", 'Children aged less than 7 years', 'children when one of three supraglottic airway devices (I-gel, AuraGain and air-Q laryngeal airway']","['AuraGain and air-Q', 'tracheal tube placed through three supraglottic airway devices']","['distance from the ventilation outlet to the glottis (mean\u200a±\u200aSD', 'safety margin', 'fibre-optic view score and the oropharyngeal leak pressure', 'safety margin: the distance between the ventilation outlet of the supraglottic airway device and the beginning of the proximal cuff minus that from the ventilation outlet to the glottis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C3873831', 'cui_str': 'Laryngeal airway'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}]",,0.0713464,The three devices exhibited significant differences in the distance from the ventilation outlet to the glottis (mean ± SD),"[{'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (JHL, SP, YEJ, EHK, HSK, JTK).'}, {'ForeName': 'Seoyeong', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001070']
325,31567574,The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study.,"BACKGROUND


Orthotopic liver transplantation is associated with a risk of bleeding. Coagulation in cirrhotic patients is difficult to assess with standard coagulation tests because of rebalanced coagulation. This can be better assessed by thromboelastometry which can detect coagulation impairments more specifically in such patients.
OBJECTIVES


Our first objective was to compare the number of units of blood products transfused during liver transplantation when using an algorithm based on standard coagulation tests or a thromboelastometry-guided transfusion algorithm.
DESIGN


Randomised controlled trial.
SETTING


Single-centre tertiary care hospital in France, from December 2014 to August 2016.
PARTICIPANTS


A total of 81 adult patients undergoing orthotopic liver transplantation were studied. Patients were excluded if they had congenital coagulopathies.
INTERVENTION


Transfusion management during liver transplantation was guided either by a standard coagulation test algorithm or by a thromboelastometry-guided algorithm. Transfusion, treatments and postoperative outcomes were compared between groups.
MAIN OUTCOME MEASURES


Total number of transfused blood product units during the operative period (1 U is one pack of red blood cells (RBCs), fresh frozen plasma (FFP) or platelets).
RESULTS


Median [interquartile range] intra-operative transfusion requirement was reduced in the thromboelastometry group (3 [2 to 4] vs. 7 [4 to 10] U, P = 0.005). FFP and tranexamic acid were administered less frequently in the thromboelastometry group (respectively 15 vs. 46.3%, P = 0.002 and 27.5 vs. 58.5%, P = 0.005), whereas fibrinogen was more often infused in the thromboelastometry group (72.5 vs. 29.3%, P < 0.001). Median transfusions of FFP (3 [2 to 6] vs. 4 [2 to 7] U, P = 0.448), RBCs (3 [2 to 5] vs. 4 [2 to 6] U, P = 0.330) and platelets (1 [1 to 2] vs. 1 [1 to 2] U, P = 0.910) were not different between groups. In the postoperative period, RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage were not different between groups.
CONCLUSION


A transfusion algorithm based on thromboelastometry assessment of coagulation reduced the total number of blood product units transfused during liver transplantation, particularly FFP administration.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02352181.",2019,"In the postoperative period, RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage were not different between groups.
","['A total of 81 adult patients undergoing orthotopic liver transplantation were studied', 'Single-centre tertiary care hospital in France, from December 2014 to August 2016', 'orthotopic liver transplantation', 'Patients were excluded if they had congenital coagulopathies', 'cirrhotic patients']","['thromboelastometry-based algorithm', 'Transfusion management during liver transplantation was guided either by a standard coagulation test algorithm or by a thromboelastometry-guided algorithm', 'FFP and tranexamic acid']","['Median [interquartile range] intra-operative transfusion requirement', 'RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage', 'fibrinogen', 'Median transfusions of FFP', 'RBCs', 'Total number of transfused blood product units during the operative period (1\u200aU is one pack of red blood cells (RBCs), fresh frozen plasma (FFP) or platelets']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}]","[{'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1100331', 'cui_str': '1-(tBuS)-(DHMRP)U'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]",81.0,0.167165,"In the postoperative period, RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage were not different between groups.
","[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bonnet', 'Affiliation': ""From the Département d'Anesthésie et Réanimation (AB, NG, NS, MG, DQ, FA), Département de Chirurgie Hépatobiliaire et de Transplantation hépatique (J-YM) and Centre de Recherche Clinique, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France (PP, MM).""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gilquin', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Steer', 'Affiliation': ''}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gazon', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Quattrone', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Pradat', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Maynard', 'Affiliation': ''}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mabrut', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Aubrun', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001084']
326,31567576,Preventing hypothermia in outpatient plastic surgery by self-warming or forced-air-warming blanket: A randomised controlled trial.,"BACKGROUND


In our outpatient post anaesthesia unit patients reported that they were feeling cold with or without shivering. Anaesthetic agents cause reduced thermoregulation, initially by redistribution of blood flow from core to periphery, later by negative balance between thermogenesis and heat loss. Even mild peri-operative hypothermia increases the risk of surgical wound infections, bleeding, impaired cardiac function, shivering, and decreases comfort.
OBJECTIVE(S)


We aimed to evaluate which of our current active warming measures, self-warming blanket or forced-air-warming blanket, were most effective in preventing inadvertent intraoperative heat loss. Secondarily, we assessed whether they prevented inadvertent peri-operative hypothermia when defined as core body temperature below 36 °C.
DESIGN


Randomised controlled trial, parallel group design.
SETTING


Aleris Solsiden hospital for outpatient surgery, Trondheim, Norway, from March to June 2016.
PATIENTS


A total of 112 consecutive patients planned for outpatient plastic surgery. Reasons for noninclusion: failing to meet the criteria for outpatient surgery according to the standard of the national society of anaesthesiology.
INTERVENTION(S)


Patients were randomised to active warming by a self-warming blanket or a forced-air-warming blanket. All patients received routine measures to prevent hypothermia with a high temperature in the operation theatres, prewarmed fluids, cotton blankets and surgical draping outside the surgical field.
MAIN OUTCOMES


Temperature, measured pre-operatively, every 10 min during general anaesthesia and postoperatively with a zero-heat-flux temperature sensor.
RESULTS


Core temperature was significantly lower in the self-warming blanket compared with the forced-air-warming blanket group during anaesthesia, P less than 0.0001. Hypothermia (<36 °C) was recorded in 47%, n = 22, patients in the self-warming blanket group and 25%, n = 16, in the forced-air-warming blanket group during the registration period, P = 0.02.
CONCLUSION


An underbody forced-air-warming blanket reduced heat loss to a greater extent than a self-warming blanket. But none of the interventions were sufficient to prevent inadvertent peri-operative hypothermia.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03163563.",2019,"RESULTS


Core temperature was significantly lower in the self-warming blanket compared with the forced-air-warming blanket group during anaesthesia, P less than 0.0001.","['112 consecutive patients planned for outpatient plastic surgery', 'Aleris Solsiden hospital for outpatient surgery, Trondheim, Norway, from March to June 2016']","['self-warming or forced-air-warming blanket', 'active warming by a self-warming blanket or a forced-air-warming blanket']","['risk of surgical wound infections, bleeding, impaired cardiac function, shivering, and decreases comfort', 'Hypothermia']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1719899', 'cui_str': 'Forced air warming blanket'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0179330', 'cui_str': 'Blanket, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]",112.0,0.0646213,"RESULTS


Core temperature was significantly lower in the self-warming blanket compared with the forced-air-warming blanket group during anaesthesia, P less than 0.0001.","[{'ForeName': 'Stig S', 'Initials': 'SS', 'LastName': 'Tyvold', 'Affiliation': 'From Aleris Hospital and Radiology Solsiden Trondheim, Norway.'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001087']
327,32255565,Risk factors and the potential of nomogram for predicting hospital-acquired pressure injuries.,"This 1:5 case-control study aimed to identify the risk factors of hospital-acquired pressure injuries (HAPIs) and to develop a mathematical model of nomogram for the risk prediction of HAPIs. Data for 370 patients with HAPIs and 1971 patients without HAPIs were extracted from the adverse events and the electronic medical systems. They were randomly divided into two sets: training (n = 1951) and validation (n = 390). Significant risk factors were identified by univariate and multivariate analyses in the training set, followed by a nomogram constructed. Age, independent movement, sensory perception and response, moisture, perfusion, use of medical devices, compulsive position, hypoalbuminaemia, an existing pressure injury or scarring from a previous pressure injury, and surgery sufferings were considered significant risk factors and were included to construct a nomogram. In both of the training and validation sets, the areas of 0.90 under the receiver operating characteristic curves showed excellent discrimination of the nomogram; calibration plots demonstrated a good consistency between the observed probability and the nomogram's prediction; decision curve analyses exhibited preferable net benefit along with the threshold probability in the nomogram. The excellent performance of the nomogram makes it a convenient and reliable tool for the risk prediction of HAPIs.",2020,"In both of the training and validation sets, the areas of 0.90 under the receiver operating characteristic curves showed excellent discrimination of the nomogram; calibration plots demonstrated a good consistency between the observed probability and the nomogram's prediction; decision curve analyses exhibited preferable net benefit along with the threshold probability in the nomogram.",['370 patients with HAPIs and 1971 patients without HAPIs'],[],"['movement, sensory perception and response, moisture, perfusion, use of medical devices, compulsive position, hypoalbuminaemia, an existing pressure injury or scarring']","[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0239981', 'cui_str': 'Hypoalbuminemia'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",370.0,0.0151185,"In both of the training and validation sets, the areas of 0.90 under the receiver operating characteristic curves showed excellent discrimination of the nomogram; calibration plots demonstrated a good consistency between the observed probability and the nomogram's prediction; decision curve analyses exhibited preferable net benefit along with the threshold probability in the nomogram.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Epidemiology and Health Statistics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiuming', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Pain Management, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Tianjun', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Precision Medicine Center of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Epidemiology and Health Statistics, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",International wound journal,['10.1111/iwj.13362']
328,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
329,32276881,Eat Like a Chef: A Mindful Eating Intervention for Health Care Providers.,"OBJECTIVE


To compare changes in mindful eating habits between students receiving a mindful eating intervention (MEI) vs those who were engaged in usual course work.
METHODS


From 2017 to 2019, 109 nutrition and medical students completed a quasi-experimental study, including usual course work either with or without the addition of a 5-week MEI. The Mindful Eating Questionnaire (MEQ) was completed before and after the MEI. Repeated measures MANOVA was used to detect differences in changes in the overall MEQ score and its 5 subscales between groups.
RESULTS


Within the MEI group (n = 64), overall MEQ, disinhibition, and eating with awareness scores increased significantly (P < .001, P < .001, and P = .004, respectively). No significant changes were noted within the comparison group (n = 45). Significant between-group differences were noted for the changes in the overall MEQ (P = .03) and disinhibition scores (P = .01).
CONCLUSIONS AND IMPLICATIONS


MEI participation may improve students' overall mindful eating scores. Future research could assess a larger cohort of participants, including health care professionals from other disciplines, assess additional mindfulness measures, and follow students for a longer period to determine the long-term effects on participants' mindful eating.",2020,"Significant between-group differences were noted for the changes in the overall MEQ (P = .03) and disinhibition scores (P = .01).
","['mindful eating habits between students receiving a mindful eating intervention (MEI) vs those who were engaged in usual course work', 'From 2017 to 2019']",[],"['overall MEQ', 'overall MEQ, disinhibition, and eating with awareness scores', 'overall MEQ score', 'Mindful Eating Questionnaire (MEQ', 'disinhibition scores']","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0290886,"Significant between-group differences were noted for the changes in the overall MEQ (P = .03) and disinhibition scores (P = .01).
","[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Knol', 'Affiliation': 'Department of Human Nutrition and Hospitality Management, University of Alabama, Tuscaloosa, AL. Electronic address: lknol@ches.ua.edu.'}, {'ForeName': 'Jeannine C', 'Initials': 'JC', 'LastName': 'Lawrence', 'Affiliation': 'College of Human Environmental Sciences, University of Alabama, Tuscaloosa, AL.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'de la O', 'Affiliation': 'Department of Human Nutrition and Hospitality Management, University of Alabama, Tuscaloosa, AL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.02.024']
330,32240156,HIV testing and treatment coverage achieved after 4 years across 14 urban and peri-urban communities in Zambia and South Africa: An analysis of findings from the HPTN 071 (PopART) trial.,"BACKGROUND


In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set the 90-90-90 targets: that 90% of people living with HIV know their HIV status, that 90% of those who know their HIV-positive status are on antiretroviral therapy (ART), and that 90% of those on treatment are virally suppressed. The aim was to reach these targets by 2020. We assessed the feasibility of achieving the first two targets, and the corresponding 81% ART coverage target, as part of the HIV Prevention Trials Network (HPTN) 071 Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART) community-randomized trial.
METHODS AND FINDINGS


The study population was individuals aged ≥15 years living in 14 urban and peri-urban ""PopART intervention"" communities in Zambia and South Africa (SA), with a total population of approximately 600,000 and approximately 15% adult HIV prevalence. Community HIV care providers (CHiPs) delivered the PopART intervention during 2014-2017. This was a combination HIV prevention package including universal home-based HIV testing, referral of HIV-positive individuals to government HIV clinic services that offered universal ART (Arm A) or ART according to national guidelines (Arm B), and revisits to HIV-positive individuals to support linkage to HIV care and retention on ART. The intervention was delivered in 3 ""rounds,"" each about 15 months long, during which CHiPs visited all households and aimed to contact all individuals aged ≥15 years at least once. In Arm A in Round 3 (R3), 67% (41,332/61,402) of men and 86% (56,345/65,896) of women in Zambia and 56% (17,813/32,095) of men and 71% (24,461/34,514) of women in SA participated in the intervention, among 193,907 residents aged ≥15 years. Following participation, HIV status was known by 90% of men and women in Zambia and by 78% of men and 85% of women in SA. The median time from CHiP referral of HIV-positive individuals to ART initiation was approximately 3 months. By the end of R3, an estimated 95% of HIV-positive women and 85% of HIV-positive men knew their HIV status, and among these individuals, approximately 90% of women and approximately 85% of men were on ART. ART coverage among all HIV-positive individuals was approximately 85% in women and approximately 75% in men, up from about 45% at the start of the study. ART coverage was lowest among men aged 18 to 34 and women aged 15 to 24 years, and among mobile individuals/in-migrants. Findings from Arm B were similar. The main limitations to our study were that estimates of testing and treatment coverage among men relied on considerable extrapolation because, in each round, approximately one-third of men did not participate in the PopART intervention; that our findings are for a service delivery model that was relatively intensive; and that we did not have comparable data from the 7 ""standard-of-care"" (Arm C) communities.
CONCLUSIONS


Our study showed that very high HIV testing and treatment coverage can be achieved through persistent delivery of universal testing, facilitated linkage to HIV care, and universal treatment services. The ART coverage target of 81% was achieved overall, after 4 years of delivery of the PopART intervention, though important gaps remained among men and young people. Our findings are consistent with previously reported findings from southern and east Africa, extending their generalisability to urban settings with high rates of in-migration and mobility and to Zambia and SA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01900977.",2020,"ART coverage was lowest among men aged 18 to 34 and women aged 15 to 24 years, and among mobile individuals/in-migrants.","['men aged 18 to 34 and women aged 15 to 24 years, and among mobile individuals/in-migrants', '193,907 residents aged ≥15 years', 'universal home-based HIV testing, referral of HIV-positive individuals to government HIV clinic services', 'study population was individuals aged ≥15 years living in 14 urban and peri-urban ""PopART intervention"" communities in Zambia and South Africa (SA), with a total population of approximately 600,000 and approximately 15% adult HIV prevalence', '14 urban and peri-urban communities in Zambia and South Africa']",['PopART intervention'],['ART coverage'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}]",,0.221617,"ART coverage was lowest among men aged 18 to 34 and women aged 15 to 24 years, and among mobile individuals/in-migrants.","[{'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Blia', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'FHI 360, HIV Prevention Trials Network, Durham, North Carolina, United States of America.'}, {'ForeName': 'Mwelwa', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Sloot', 'Affiliation': 'Department of Global Health and Policy, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Sabapathy', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Department of Global Health and Policy, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'HIV Clinical Trials Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003067']
331,32240228,Randomized pilot trial for the efficacy of the MMF07 foot massager and heat therapy for restless legs syndrome.,"BACKGROUND


Restless Legs Syndrome (RLS) is a sensorimotor condition with a wide range of severity. Symptoms negatively affect sleep and quality of life. Pharmacologic options are not universally effective and side effects are common. Objective data regarding non-pharmacologic treatment is limited. The study objective was to evaluate the efficacy of the MMF07 foot massager and heat therapy on the severity of RLS symptoms.
METHODS


In this pilot randomized controlled trial, twenty-eight patients with diagnosed, bothersome RLS were randomized to four treatment arms: no active intervention (n = 7), foot massager (n = 8), heat therapy (n = 6), and foot massager plus heat therapy (n = 7). Participants completed the RLS Severity Scale, RLS Quality of Life questionnaire, and the Medical Outcomes Study Sleep scale at the baseline visit and at the 4-week follow up visit.
RESULTS


Four weeks post randomization, participants in the massager group had significant improvement in the RLS severity score (average difference: -9.0, 95% CI: -16.3, -1.7, p = 0.017) and sleep scale (average difference: -22.0, 95% CI: -36.5, -7.5, p = 0.005) compared to the no intervention group. The heat alone group had a significant improvement in the sleep scale compared to the no-intervention group (average difference: -17.4, 95% CI: -32.5, -2.3, p = 0.026). Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072).
CONCLUSIONS


Results suggest that the MMF07 foot massage device and heat therapy may be feasible and effective treatment options to improve RSL symptoms.",2020,"Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072).
","['restless legs syndrome', 'twenty-eight patients with diagnosed, bothersome RLS']","['MMF07 foot massager and heat therapy', 'foot massager (n = 8), heat therapy (n = 6), and foot massager plus heat therapy', 'no active intervention']","['sleep scale', 'RSL symptoms', 'sleep and quality of life', 'RLS Severity Scale, RLS Quality of Life questionnaire, and the Medical Outcomes Study Sleep scale', 'Quality of life', 'RLS severity score']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",28.0,0.104081,"Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072).
","[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': ""Department of Neurology, Madden Center for Parkinson's Disease and Related Disorders, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ambrogi', 'Affiliation': ""Department of Neurology, Madden Center for Parkinson's Disease and Related Disorders, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.""}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.'}]",PloS one,['10.1371/journal.pone.0230951']
332,31188153,Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial.,"BACKGROUND


Neuraxial ultrasound might improve the efficacy of spinal anaesthesia but this has not been tested for the paramedian approach in the elderly.
OBJECTIVE


The current study aims to assess whether the ultrasound-assisted paramedian technique can decrease the number of needle passes required for success compared with the landmark-guided paramedian technique in the elderly.
DESIGN


Randomised controlled study.
SETTING


Single-institution, tertiary-level hospital in Seoul, Republic of Korea from October 2017 to January 2018.
PATIENTS


Eighty patients aged at least 60 years undergoing orthopaedic surgery.
INTERVENTION


All received paramedian spinal anaesthesia by either the landmark-guided or preprocedural ultrasound-assisted technique.
MAIN OUTCOME MEASURES


The number of needle passes required for successful dural puncture.
RESULTS


The number of needle passes (median [interquartile range]) was significantly lower (1.0 [1.0 to 2.0] vs. 4.5 [2.0 to 7.0]) and the success rate at first pass significantly higher at 65.0 vs. 17.5% in the ultrasound compared with the landmark group (both P < 0.001). The ultrasound-assisted technique required a longer time for establishing landmarks (117.5 s [85.5 to 150.7 s] vs. 17.5 s [14.0 to 23.0 s]) and for total procedure (181.5 s [133.5 to 212.5 s] vs. 92.5 s [62.5 to 176.5 s]) but a shorter time for administering spinal anaesthesia (39.5 s [31.5 to 71.3 s] vs. 77.0 s [45.8 to 136.5 s]; all, P < 0.001) than the palpation-guided technique. The ultrasound group showed lower periprocedural pain scores (3 [2 to 4] vs. 4 [4 to 6]; P = 0.009) and discomfort scores (2 [0 to 3] vs. 5 [2 to 6]; P = 0.003) than the landmark group.
CONCLUSION


Compared with the landmark-guided paramedian technique, the ultrasound-assisted paramedian technique decreases the number of needle manipulations and periprocedural pain and discomfort scores in the elderly. Our results suggest that neuraxial ultrasonography facilitates the performance of spinal anaesthesia in the elderly.
TRIAL REGISTRATION


NCT03316352.",2019,"The ultrasound-assisted technique required a longer time for establishing landmarks 117.5 [85.5 to 150.7] vs. 17.5 [14.0 to 23.0] s, and for total procedure 181.5 [133.5 to 212.5] vs. 92.5 [62.5 to 176.5] s, but a shorter time for administering spinal anaesthesia 39.5 [31.5 to 71.3] vs. 77.0 [45.8 to 136.5] s (","['elderly', 'Single-institution, tertiary-level hospital in Seoul, Republic of Korea from October 2017 to January 2018', 'Eighty patients aged at least 60 years undergoing orthopaedic surgery']","['ultrasound-assisted paramedian technique', 'Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia', 'neuraxial ultrasonography', 'paramedian spinal anaesthesia by either the landmark-guided or preprocedural ultrasound-assisted technique', 'landmark-guided paramedian technique, the ultrasound-assisted paramedian technique']","['success rate', 'number of needle passes', 'number of needle manipulations and periprocedural pain and discomfort scores', 'shorter time for administering spinal anaesthesia', 'periprocedural pain scores', 'discomfort scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",80.0,0.0816481,"The ultrasound-assisted technique required a longer time for establishing landmarks 117.5 [85.5 to 150.7] vs. 17.5 [14.0 to 23.0] s, and for total procedure 181.5 [133.5 to 212.5] vs. 92.5 [62.5 to 176.5] s, but a shorter time for administering spinal anaesthesia 39.5 [31.5 to 71.3] vs. 77.0 [45.8 to 136.5] s (","[{'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea (S-KP, SY, WHK, Y-JL, J-HB, J-TK).'}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001029']
333,32267102,Impact of simultaneous subthalamic and nigral stimulation on dysphagia in Parkinson's disease.,"OBJECTIVES


Dysphagia is a frequent and highly relevant symptom in Parkinson's disease (PD) due to high associated morbidity and mortality. To compare the effect of simultaneous stimulation of the subthalamic nucleus (STN) and substantia nigra (SNr) with conventional STN-stimulation on swallowing function in Parkinson's disease.
METHODS


In this controlled, randomized, double-blind, cross-over clinical trial, 15 PD patients were assessed with DBS switched off (STIM OFF), STN-DBS, STN + SNr-DBS. Patients and 32 age-matched healthy controls were examined clinically and by flexible-endoscopic evaluation of swallowing (FEES) to evaluate the swallowing function. The primary endpoint was the assessment of residues, secondary endpoints were penetration/aspiration, leakage, retained pharyngeal secretions, drooling, and assessments of the patient's self-perception of swallowing on a visual analog scale.
RESULTS


Compared with healthy controls PD patients showed significantly more pharyngeal residues in STIM OFF and both DBS modes. Residues or aspiration events were found in 80% of the patients under STN-stimulation. Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
INTERPRETATION


Simultaneous STN + SNr-stimulation seems to have no additional beneficial effects on dysphagia when compared with conventional STN-stimulation, but did not deteriorate the swallowing function. If STN + SNr-stimulation is planned to be applied for the improvement of axial symptoms and gait disorders in PD patients, it can be considered safe in terms of dysphagia.",2020,"Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
","['PD patients', ""dysphagia in Parkinson's disease"", '15 PD patients', 'Patients and 32 age-matched healthy controls', ""Parkinson's disease""]","['simultaneous subthalamic and nigral stimulation', 'flexible-endoscopic evaluation of swallowing (FEES', 'simultaneous stimulation of the subthalamic nucleus (STN) and substantia nigra (SNr) with conventional STN-stimulation']","['objective dysphagia and self-reported swallowing function', 'swallowing function', ""assessment of residues, secondary endpoints were penetration/aspiration, leakage, retained pharyngeal secretions, drooling, and assessments of the patient's self-perception of swallowing on a visual analog scale"", 'Residues or aspiration events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0038590', 'cui_str': 'Substantia nigra structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0227143', 'cui_str': 'Pharyngeal mucus'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",15.0,0.0491266,"Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pflug', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Nienstedt', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gulberti', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Jana-Christiane', 'Initials': 'JC', 'LastName': 'Koseki', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Niessen', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Flügel', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Hidding', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Buhmann', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Centre of Neurology, Department for Neurodegenerative Diseases and Hertie-Institute for Clinical Brain Research, Tübingen, 72076, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hamel', 'Affiliation': 'Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Christian K E', 'Initials': 'CKE', 'LastName': 'Moll', 'Affiliation': 'Department of Neurophysiology and Pathophysiology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51027']
334,32253543,Energy replacement diminishes the postprandial triglyceride-lowering effect from accumulated walking in older women.,"PURPOSE


Dietary replacement of an acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise in young boys and middle-aged men. It is unclear whether these findings are observed when exercise is accumulated in older adults. This study examined the effect of accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit, on postprandial TG in older women.
METHODS


Seventeen older women (≥ 65 years) underwent three, 8-h trials: (1) control, (2) accumulated walking and (3) accumulated walking with energy replacement. During the control trial, participants rested for 8 h. The accumulated walking trials comprised twenty 1.5 min brisk walking bouts performed at a pre-determined self-selected pace separated by 15 min seated rest. In each trial, participants consumed a standardised breakfast and lunch. The breakfast in the accumulated walking with energy replacement trial included replacement of the energy deficit (0.62 MJ, 149 kcal) induced by exercise. Venous blood samples were collected fasted and at 2, 4, 6 and 8 h after breakfast.
RESULTS


Time-averaged postprandial serum TG concentrations over 8 h were lower after accumulated walking than control and accumulated walking with energy replacement (mean ± SD: 1.46 ± 0.93 vs 1.71 ± 1.01 vs 1.60 ± 0.98 mmol/L, respectively: main effect of trial p = 0.017). There was little difference between control and accumulated walking with energy replacement.
CONCLUSIONS


Replacing the energy expenditure induced by accumulating 30 min of brisk walking in short (1.5 min) bouts diminishes the postprandial TG-lowering effect in older women.",2020,"There was little difference between control and accumulated walking with energy replacement.
","['young boys and middle-aged men', 'older women', 'Seventeen older women (≥', 'older adults']","['control, (2) accumulated walking and (3) accumulated walking with energy replacement', 'acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise', 'accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit', 'min brisk walking bouts performed at a pre-determined self-selected pace separated by 15\xa0min seated rest']","['Venous blood samples', 'postprandial TG-lowering effect', 'postprandial triglyceride-lowering effect', 'Time-averaged postprandial serum TG concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.0628431,"There was little difference between control and accumulated walking with energy replacement.
","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan. m.miyashita@waseda.jp.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Fujihira', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Nagayama', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Organization for University Research Initiatives, Waseda University, Singapore, 139651, Singapore.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Burns', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, 637616, Singapore.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02234-z']
335,32253548,Additional benefits of multiple-dose tranexamic acid to anti-fibrinolysis and anti-inflammation in total knee arthroplasty: a randomized controlled trial.,"BACKGROUND


Consensus is lacking regarding the dose and timing of tranexamic acid (TXA). The aim of this study was to determine whether multiple-dose intravenous TXA further reduced blood loss and attenuated inflammation after total knee arthroplasty (TKA).
MATERIALS AND METHODS


We prospectively studied four regimens on TXA: no TXA (A), before incision, 3, 6, and 12 h later (B), before incision, 3, 6, 12, and 18 h later (C) and before incision, 3, 6, 12, 18, and 24 h later (D). The primary outcome was hidden blood loss (HBL). Other outcome measurements such as total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications were also compared.
RESULTS


The mean HBL and TBL were significantly lower in Group D than in Groups C, B and A. The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively. The VAS score on postoperative days 1 and 3 (POD1 and POD3) was significantly lower in Group D than in Groups C, B and A. There was no significant difference in LOS among groups. No patient underwent blood transfusion. No episodes of deep venous thrombosis or pulmonary embolism occurred in all the groups.
CONCLUSION


The repeated doses of TXA up to 24 h can further diminish HBL, provide additional fibrinolysis and inflammation control and ameliorate postoperative pain following TKA.
LEVEL OF EVIDENCE


I.",2020,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","['total knee arthroplasty (TKA', 'total knee arthroplasty']","['tranexamic acid (TXA', 'TXA: no TXA', 'tranexamic acid', 'TXA']","['mean HBL and TBL', 'VAS score on postoperative days 1 and 3 (POD1 and POD3', 'level of inflammatory factors and fibrinolysis parameters', 'blood loss', 'deep venous thrombosis or pulmonary embolism', 'LOS', 'total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications', 'hidden blood loss (HBL']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0722236', 'cui_str': 'Ogen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205262', 'cui_str': 'Occult'}]",,0.0903729,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China. huangw511@163.com.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China. peifux@126.com.""}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03442-2']
336,32166907,Combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in people with type 1 diabetes: A randomized crossover trial.,"AIM


To investigate the efficacy of a combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) versus an optimized degludec-based multiple daily injections (MDI) regimen + self-monitoring of blood glucose (SMBG) in people with type 1 diabetes with regard to optimizing glucose control.
MATERIAL AND METHODS


The trial included 28 individuals who underwent a 4-week run-in phase, and were then randomized 1:1 to: (a) CSII + CGM followed by MDI + SMBG or (b) an MDI basal-bolus regimen followed by CSII + CGM.
RESULTS


In patients randomized to the CSII + CGM → MDI + SMBG arm, a significant reduction in glycated haemoglobin (HbA1c) versus baseline was found at the end of the first phase (CSII + CGM) without significant variation in the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG → CSII + CGM sequence, a significant improvement in HbA1c was observed in the first phase (MDI + SMBG), together with a further decrease in the following CSII + CGM phase. In the comparison of the two treatments using a mixed linear model, CSII + CGM was superior to MDI + SMBG with respect to change in HbA1c (P = 0.001).
CONCLUSIONS


This study suggests that CSII + CGM improves glycaemic control without relevant safety issues in type 1 diabetes, in comparison with MDI + SMBG.",2020,"In the comparison of the two treatments with a mixed linear model, CSII+CGM was superior to MDI + SMBG with respect to change in HbA1c (p = 0.001).
","['28 individuals who underwent a 4-week run-in phase', 'type 1 diabetes', 'T1DM subjects in optimizing glucose control']","['CGM and CSII versus an optimized degludec-based MDI regimen + SMBG', 'Multiple Daily Injections (MDI) with traditional self-monitoring of blood glucose (SMBG', 'Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM', 'combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections', 'CSII+CGM', 'CSII+CGM followed by MDI\u2009+\u2009SMBG or 2) an MDI basal-bolus regimen followed by CSII+CGM']","['HbA1c', 'nocturnal hypoglycemia']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}]",28.0,0.0232444,"In the comparison of the two treatments with a mixed linear model, CSII+CGM was superior to MDI + SMBG with respect to change in HbA1c (p = 0.001).
","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Dicembrini', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pala', 'Affiliation': 'Diabetes Unit, Careggi Teaching Hospital, Florence, Italy.'}, {'ForeName': 'Mariasmeralda', 'Initials': 'M', 'LastName': 'Caliri', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Minardi', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cosentino', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Monami', 'Affiliation': 'Diabetes Unit, Careggi Teaching Hospital, Florence, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Mannucci', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14028']
337,32243432,"Investigating the impact of early-life adversity on physiological, immune, and gene expression responses to acute stress: A pilot feasibility study.","OBJECTIVE


Exposure to early-life adversity (ELA) can result in long-term changes to physiological systems, which predispose individuals to negative health outcomes. This biological embedding of stress-responsive systems may operate via dysregulation of physiological resources in response to common stressors. The present pilot study outlines a novel experimental design to test how young adults' exposure to ELA influences neuroendocrine and inflammatory responses to acute stress.
MATERIALS AND METHODS


Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls'). Using a randomized within-subjects, between-groups experimental design, we induced acute psychosocial stress (Trier Social Stress Test, TSST), and included a no-stress control condition one week apart. During these sessions, we obtained repeated measurements of physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα) over a 4-hour window post-test.
RESULTS


In this pilot study, the ELA group evinced higher cortisol response and blunted NR3C1 gene expression in response to the TSST compared with controls, while no differences were observed in the no-stress condition. For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups.
CONCLUSION


Overall, this pilot feasibility study provides a framework to investigate the biological embedding of early-adversity via dysregulation across physiological and genomic systems in response to acute psychosocial stress. ELA may program such systems in a maladaptive manner more likely to manifest during times of duress, predisposing individuals to the negative health consequences of everyday stressors. Future studies with larger sample size including both males and females are needed to replicate and expand upon these preliminary findings.",2020,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups.
","['young adults', 'acute stress', ""Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls""]","['TSST', 'ELA']","['physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα', 'cortisol response and blunted NR3C1 gene expression', 'acute psychosocial stress (Trier Social Stress Test, TSST']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",12.0,0.0355585,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups.
","[{'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Shalev', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Waylon J', 'Initials': 'WJ', 'LastName': 'Hastings', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Etzel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Russell', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Kelsie A', 'Initials': 'KA', 'LastName': 'Hendrick', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zinobile', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Sue Rutherford', 'Initials': 'SR', 'LastName': 'Siegel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}]",PloS one,['10.1371/journal.pone.0221310']
338,32266180,"Efficacy of Cereal-based Oral Nutrition Supplement on Nutritional Status, Inflammatory Cytokine Secretion and Quality of Life in Cancer Patients Under Cancer Therapy.","A rapid increase in cancer incidence accompanied by aging population requires evidence-based supportive cancer care practices. Cancer therapies often accompany adverse events which induce malnutrition and declined quality of life. We conducted an 8-week non-randomized clinical trial to evaluate efficacy of cereal-based oral nutritional supplement (ONS) intervention on nutritional status, quality of life and inflammatory responses in cancer patients undergoing cancer therapy with 5% < weight loss. The study included 34 pateints (24 in control group, 10 in intervention group) with 15 drop-outs. ONS used in this intervention contained 0.5% arabinoxylan-rich fermented rice bran powder and 5.5% black rice powder as active ingredients in a regular cereal-based formula. Results showed that ONS intervention for 8 weeks did not show significant improvement in blood biomarkers of nutritional status or patient-generated subjective global assessment scores. However, 8-week of intervention showed reduced interleukin (IL)-6 and IL-1β secretion in lipopolysaccharide-stimulated peripheral blood mononuclear cells while IL-12p70 level was increased. For health-related quality of life (HRQoL) indices, emotional functioning and fatigue symptoms were improved after 4 weeks only in the intervention group although no difference was found at week 8. These results suggest that ONS intervention may improve chronic inflammatory status and HRQoL indices (at week 4) in cancer patients receiving treatments.",2020,"For health-related quality of life (HRQoL) indices, emotional functioning and fatigue symptoms were improved after 4 weeks only in the intervention group although no difference was found at week 8.","['cancer patients receiving treatments', 'cancer patients undergoing cancer therapy with 5% < weight loss', '34 pateints (24 in control group, 10 in intervention group) with 15 drop-outs', 'Cancer Patients Under Cancer Therapy']","['arabinoxylan-rich fermented rice bran powder and 5.5% black rice powder', 'cereal-based oral nutritional supplement (ONS) intervention', 'Cereal-based Oral Nutrition Supplement', 'ONS intervention']","['nutritional status, quality of life and inflammatory responses', 'blood biomarkers of nutritional status or patient-generated subjective global assessment scores', 'chronic inflammatory status and HRQoL indices', 'reduced interleukin (IL)-6 and IL-1β secretion in lipopolysaccharide-stimulated peripheral blood mononuclear cells while IL-12p70 level', 'Nutritional Status, Inflammatory Cytokine Secretion and Quality of Life', 'For health-related quality of life (HRQoL) indices, emotional functioning and fatigue symptoms']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439787', 'cui_str': 'Out'}]","[{'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0982374', 'cui_str': 'RICE BRAN'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",34.0,0.0271127,"For health-related quality of life (HRQoL) indices, emotional functioning and fatigue symptoms were improved after 4 weeks only in the intervention group although no difference was found at week 8.","[{'ForeName': 'Jin-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': ""Department of Food and Nutrition, College of Human Ecology, Sookmyung Women's University, Seoul, Korea.""}, {'ForeName': 'Sung-Gil', 'Initials': 'SG', 'LastName': 'Hong', 'Affiliation': 'Department of Biotechnology, Advanced Radiation Technology Institute, Korea Atomic Energy Institute, Jeongeup, Korea.'}, {'ForeName': 'Bum-Seok', 'Initials': 'BS', 'LastName': 'Song', 'Affiliation': 'Erom Institute of Life Sciences, Chuncheon, Korea.'}, {'ForeName': 'Hee-Jung', 'Initials': 'HJ', 'LastName': 'Sohn', 'Affiliation': 'Departments of Hemato-Oncology, Bundang Jesaeng Hospital, Seongnam, Korea.'}, {'ForeName': 'Hyunwook', 'Initials': 'H', 'LastName': 'Baik', 'Affiliation': 'Departments of Clinical Nutrition Medicine, Bundang Jesaeng Hospital, Seongnam, Korea.'}, {'ForeName': 'Mi-Kyung', 'Initials': 'MK', 'LastName': 'Sung', 'Affiliation': ""Department of Food and Nutrition, College of Human Ecology, Sookmyung Women's University, Seoul, Korea.""}]",Journal of cancer prevention,['10.15430/JCP.2020.25.1.55']
339,32272284,Omalizumab Re-Treatment and Step-Up in Patients with Chronic Spontaneous Urticaria: OPTIMA Trial.,"BACKGROUND


Omalizumab shows greater clinical benefit with 300 mg dose than with the 150 mg dose.
OBJECTIVE


To determine outcomes postwithdrawal, relapse, and re-treatment in omalizumab responders, and from stepping up to 300 mg after insufficient symptom control with 150 mg.
METHODS


This was a prospective, randomized (3:4), open-label, noncomparator study (clinicaltrials.gov: NCT02161562). A total of 314 adult patients with chronic spontaneous urticaria and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014, and November 6, 2015. Patients received 150 mg/300 mg omalizumab, every 4 weeks for 24 weeks. Omalizumab 150 mg dose could be stepped up to 300 mg between week 8 and week 24, if the 7-day sum of the daily Urticaria Activity Score (UAS7) was more than 6. If patients relapsed after treatment withdrawal at week 24, they could be re-treated with the same dose on which omalizumab was started. Patients on 300 mg could extend treatment by 12 weeks if they did not achieve symptom control on 300 mg in the initial dosing phase. The primary end point was the proportion of well-controlled patients who relapsed postwithdrawal, and achieved symptom control at the end of re-treatment. Symptom control was assessed using UAS7 (UAS7 ≤ 6 = well controlled).
RESULTS


Overall, 115 of 314 patients had adequate symptom control at week 24 (end of the initial dosing period) and 56 were re-treated after relapse postwithdrawal; 87.8% (95% CI, 78.6%-96.9%) regained symptomatic control (UAS7 ≤ 6). Most (141 of 178) patients initially treated with 150 mg required step-up to 300 mg, which resulted in a 9.5-point (95% CI, 7.6-11.3) improvement in UAS7 over the mean change observed initially on 150 mg.
CONCLUSIONS


Step-up to 300 mg helps a greater proportion of patients achieve symptom control, and re-treatment with omalizumab is as effective as initial therapy.",2020,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled).
","['314 adult patients with chronic spontaneous/idiopathic urticaria (CSU) and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014 and November 6, 2015', 'Patients with Chronic Spontaneous Urticaria']","['omalizumab', 'Omalizumab', 'Omalizumab Retreatment and Step-Up']","['7-day sum of daily Urticaria Activity Score', 'adequate symptom control', 'UAS7 scores', 'proportion of well-controlled patients who relapsed post-withdrawal, and achieved symptom control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0157741', 'cui_str': 'Idiopathic urticaria'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",314.0,0.0925635,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled).
","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: gsussman@rogers.com.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Hébert', 'Affiliation': ""Department of Medicine, Centre Hospitalier de l'Université Laval, Québec, QC, Canada.""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Gulliver', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St John's, NL, Canada.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Institute for Dermatology, Markham, ON, Canada.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa Medical School, Ottawa, ON, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Center for Dermatology, Queen's University and Probity Medical Research, Peterborough, ON, Canada.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Khalil', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frederica', 'Initials': 'F', 'LastName': 'DeTakacsy', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vieira', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rihakova', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.022']
340,32236104,"Effectiveness of peer counseling, social engagement, and combination interventions in improving depressive symptoms of community-dwelling Filipino senior citizens.","INTRODUCTION


Little is known about community-based interventions for geriatric depression in low-resource settings. This study assessed the effectiveness of 3-month-duration interventions with peer counseling, social engagement, and combination vs. control in improving depressive symptoms of community-dwelling Filipino senior citizens.
METHODS


We conducted an open (non-blinded), non-randomized trial of senior citizens at risk for depression. Three different 3-month interventions included peer counseling (n = 65), social engagement (n = 66), and combination (n = 65) were compared with the control group (n = 68). We assessed geriatric depression, psychological resilience, perceived social support, loneliness, and working alliance scores at baseline and three months after the intervention. This trial was registered with ClinicalTrials.gov, identifier: NCT03989284.
RESULTS


Geriatric depression score over three months significantly improved in all intervention groups (control as reference). Significant improvements were also seen in psychological resilience and social support. Not all interventions, however, significantly improved the loneliness score. The combination group showed the largest effect of improving depressive symptoms (d = -1.33) whereas the social engagement group showed the largest effect of improving psychological resilience (d = 1.40), perceived social support (d = 1.07), and loneliness (d = -0.36) among senior citizens.
CONCLUSION


At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens. This study shows that it is feasible to identify senior citizens at risk for depression in the community and intervene effectively to improve their mental health. Further studies are required to target loneliness and investigate the long-term benefits of the interventions.
CLINICAL TRIAL


ClinicalTrials.gov: NCT03989284.",2020,"At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens.","['community-dwelling Filipino senior citizens', 'senior citizens at risk for depression']","['peer counseling, social engagement, and combination vs. control', 'peer counseling (n = 65), social engagement', 'peer counseling, social engagement, and combination interventions']","['depressive symptoms', 'psychological resilience', 'geriatric depression, psychological resilience, perceived social support, loneliness, and working alliance scores', 'depressive symptoms, psychological resilience, and social support', 'loneliness score', 'Geriatric depression score', 'psychological resilience and social support', 'perceived social support']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",65.0,0.0461006,"At the community level, peer counseling, social engagement, and combination interventions were effective in improving depressive symptoms, psychological resilience, and social support among Filipino senior citizens.","[{'ForeName': 'Rogie Royce', 'Initials': 'RR', 'LastName': 'Carandang', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shibanuma', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kiriya', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Karen Rose', 'Initials': 'KR', 'LastName': 'Vardeleon', 'Affiliation': 'Childfam-Possibilities Psychosocial Services Co., Quezon City, Philippines.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Asis', 'Affiliation': 'Department of Global Studies, Faculty of Liberal Arts, Sophia University, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murayama', 'Affiliation': 'Institute of Gerontology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masamine', 'Initials': 'M', 'LastName': 'Jimba', 'Affiliation': 'Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0230770']
341,31356373,Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial.,"BACKGROUND


Pre-operative anxiety in children is very common and is associated with adverse outcomes.
OBJECTIVE


The aim of this study was to investigate if virtual reality exposure (VRE) as a preparation tool for elective day care surgery in children is associated with lower levels of anxiety, pain and emergence delirium compared with a control group receiving care as usual (CAU).
DESIGN


A randomised controlled single-blind trial.
SETTING


A single university children's hospital in the Netherlands from March 2017 to October 2018.
PATIENTS


Two-hundred children, 4 to 12 years old, undergoing elective day care surgery under general anaesthesia.
INTERVENTION


On the day of surgery, children receiving VRE were exposed to a realistic child-friendly immersive virtual version of the operating theatre, so that they could get accustomed to the environment and general anaesthesia procedures.
MAIN OUTCOME MEASURES


The primary outcome was anxiety during induction of anaesthesia (modified Yale Preoperative Anxiety Scale, mYPAS). Secondary outcomes were self-reported anxiety, self-reported and observed pain, emergence delirium, need for rescue analgesia (morphine) and parental anxiety.
RESULTS


A total of 191 children were included in the analysis. During induction of anaesthesia, mYPAS levels (median [IQR] were similar in VRE, 40.0 [28.3 to 58.3] and CAU, 38.3 [28.3 to 53.3]; P = 0.862). No differences between groups were found in self-reported anxiety, pain, emergence delirium or parental anxiety. However, after adenoidectomy/tonsillectomy, children in the VRE condition needed rescue analgesia significantly less often (55.0%) than in the CAU condition (95.7%) (P = 0.002).
CONCLUSION


In children undergoing elective day care surgery, VRE did not have a beneficial effect on anxiety, pain, emergence delirium or parental anxiety. However, after more painful surgery, children in the VRE group needed rescue analgesia significantly less often, a clinically important finding because of the side effects associated with analgesic drugs. Options for future research are to include children with higher levels of anxiety and pain and to examine the timing and duration of VRE.
TRIAL REGISTRATION


Netherlands Trial Registry: NTR6116.",2019,"In children undergoing elective day care surgery, VRE did not have a beneficial effect on anxiety, pain, emergence delirium or parental anxiety.","['children', 'Two-hundred children, 4 to 12 years old, undergoing elective day care surgery under general anaesthesia', 'elective day care surgery in children', 'children undergoing elective day care surgery', ""A single university children's hospital in the Netherlands from March 2017 to October 2018"", '191 children']","['VRE', 'control group receiving care as usual (CAU', 'Virtual reality exposure before elective day care surgery', 'virtual reality exposure (VRE']","['anxiety during induction of anaesthesia (modified Yale Preoperative Anxiety Scale, mYPAS', 'self-reported anxiety, self-reported and observed pain, emergence delirium, need for rescue analgesia (morphine) and parental anxiety', 'self-reported anxiety, pain, emergence delirium or parental anxiety', 'anxiety, pain, emergence delirium or parental anxiety', 'rescue analgesia', 'anxiety and pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}]",200.0,0.218249,"In children undergoing elective day care surgery, VRE did not have a beneficial effect on anxiety, pain, emergence delirium or parental anxiety.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Eijlers', 'Affiliation': ""From the Department of Child and Adolescent Psychiatry/Psychology (RE, BD, JMB, MHJH, JSL, EMWJU), Department of Anaesthesiology, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, The Netherlands (LMS), Department of Anaesthesia, ZNA Middelheim, Queen Paola Children's Hospital, Antwerp, Belgium (JMB), Dutch Craniofacial Centre (MPvdS), Department of Otorhinolaryngology and Head and Neck Surgery (MPvdS), Department of Oral and Maxillofacial Surgery (EMS), Intensive Care and Department of Paediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam (RMHW), Research Institute of Child Development and Education, University of Amsterdam (EMWJU), Academic Centre for Child Psychiatry De Bascule/Department of Child and Adolescent Psychiatry, Academic Medical Centre, Amsterdam, The Netherlands (EMWJU).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Dierckx', 'Affiliation': ''}, {'ForeName': 'Lonneke M', 'Initials': 'LM', 'LastName': 'Staals', 'Affiliation': ''}, {'ForeName': 'Johan M', 'Initials': 'JM', 'LastName': 'Berghmans', 'Affiliation': ''}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'van der Schroeff', 'Affiliation': ''}, {'ForeName': 'Elske M', 'Initials': 'EM', 'LastName': 'Strabbing', 'Affiliation': ''}, {'ForeName': 'René M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ''}, {'ForeName': 'Manon H J', 'Initials': 'MHJ', 'LastName': 'Hillegers', 'Affiliation': ''}, {'ForeName': 'Jeroen S', 'Initials': 'JS', 'LastName': 'Legerstee', 'Affiliation': ''}, {'ForeName': 'Elisabeth M W J', 'Initials': 'EMWJ', 'LastName': 'Utens', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001059']
342,31356376,Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial.,"BACKGROUND


Cannulation of the radial artery is challenging to perform in neonates and infants because of the small vessel size.
OBJECTIVE


To compare guidewire-assisted with direct radial artery cannulation in neonates and infants.
DESIGN


A randomised controlled study.
SETTING


A tertiary university hospital from 7 August 2017 to 4 July 2018.
PATIENTS


Ninety neonates and infants who required radial artery cannulation during general anaesthesia.
INTERVENTIONS


All patients were allocated randomly into the guidewire group (guidewire-assisted cannulation, n=45) or control group (direct cannulation, n=45). Radial artery cannulation was performed under general anaesthesia. The contralateral radial artery was used if the arterial cannulation was not successful within two attempts. After the second failure in the contralateral radial artery, the case was considered a failure.
MAIN OUTCOME MEASURES


The primary outcome was the first-attempt success rate of radial artery cannulation. The secondary outcomes included the overall success rate, overall procedure time, number of attempts and use of the contralateral radial artery for radial artery cannulation.
RESULTS


The guidewire group showed a higher first-attempt success rate [76 vs. 56%; P = 0.046; odds ratio (OR) 2.47, 95% confidence interval (CI) of odds 1.01 to 6.08] and overall success rate (96 vs. 76%; P = 0.007; OR 6.96; 95% CI 1.44 to 33.52) than the control group. The overall procedure time was not significantly different between the guidewire group (median [IQR] 36 [28.0 to 70.5] s) and control group (98 [23.5 to 465.0] s; P = 0.400). There was no difference in the median number of attempts between the two groups (P = 0.454). However, use of the contralateral radial artery was significantly lower in the guidewire group (17.8%) than in the control group (40%; P = 0.020; OR 0.324, 95% CI 0.12 to 0.86). Kaplan-Meier analysis of the overall procedure time to successful radial artery cannulation showed that the overall success rate was significantly higher in the guidewire group than in the control group (P = 0.019).
CONCLUSION


For radial artery cannulation in neonates and infants, guidewire-assisted radial artery cannulation showed superiority over the direct technique in terms of first-attempt success rate and overall success rate without delaying the procedure time.
TRIAL REGISTRATION


Clinicaltrials.gov (identifier: NCT03217019).",2019,"The guidewire group showed a higher first-attempt success rate [76 vs. 56%; P = 0.046; odds ratio (OR) 2.47, 95% confidence interval (CI) of odds 1.01 to 6.08] and overall success rate (96 vs. 76%; P = 0.007; OR 6.96; 95% CI 1.44 to 33.52) than the control group.","['Ninety neonates and infants who required radial artery cannulation during general anaesthesia', 'neonates and infants', 'A tertiary university hospital from 7 August 2017 to 4 July 2018']","['Guidewire-assisted vs. direct radial arterial cannulation', 'For radial artery cannulation', 'guidewire-assisted with direct radial artery cannulation', 'guidewire group (guidewire-assisted cannulation, n=45) or control group (direct cannulation', 'Radial artery cannulation']","['first-attempt success rate of radial artery cannulation', 'contralateral radial artery', 'higher first-attempt success rate', 'overall success rate, overall procedure time, number of attempts and use of the contralateral radial artery for radial artery cannulation', 'median number of attempts', 'overall success rate', 'overall procedure time']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0007431', 'cui_str': 'Arterial cannula insertion (procedure)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",90.0,0.35114,"The guidewire group showed a higher first-attempt success rate [76 vs. 56%; P = 0.046; odds ratio (OR) 2.47, 95% confidence interval (CI) of odds 1.01 to 6.08] and overall success rate (96 vs. 76%; P = 0.007; OR 6.96; 95% CI 1.44 to 33.52) than the control group.","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital (Y-EJ, E-HK, J-HL) and Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (H-SK, J-TK).'}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001064']
343,31582360,"Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial.","BACKGROUND


Infection with influenza virus causes substantial morbidity and mortality globally, although antiviral treatments are available. Previous studies have suggested that anti-influenza immune plasma could be beneficial as treatment, but they were not designed as randomised, blinded, placebo-controlled trials. Therefore, we aimed to prospectively evaluate the clinical efficacy of high-titre immune plasma compared with standard low-titre plasma to improve outcomes in patients with severe influenza A infection.
METHODS


We did this randomised, double-blind, phase 3 trial at 41 US medical centres to assess the efficacy of high-titre anti-influenza plasma (haemagglutination inhibition antibody titre ≥1:80) compared with low-titre plasma (≤1:10). Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible. Patients were randomly assigned (2:1) using an interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group), and were followed up for 28 days from randomisation. High-titre and low-titre plasma had the same appearance. Randomisation was stratified by severity (in intensive care unit, not in intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen) and age (<18 years and ≥18 years). All participants, site staff, and the study team were masked to treatment allocation until after the final database lock. The primary endpoint was clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities) analysed in a proportional odds model (an odds ratio [OR] >1 indicates improvement in clinical status across all categories for the high-titre vs the low-titre group). The primary analysis was done in the intention-to-treat population, excluding two participants who did not receive plasma. This trial is registered with ClinicalTrials.gov, NCT02572817.
FINDINGS


Participants were recruited between Jan 26, 2016, and April 19, 2018. Of 200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48). One participant from each group did not receive plasma. At baseline, 60 (43%) of 138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen. 93% of planned plasma infusions were completed. The study was terminated in July, 2018, when independent efficacy analysis showed low conditional power to detect an effect of high-titre plasma even if full accrual (150 participants) was achieved. The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54). 47 (34%) of 138 participants experienced 88 serious adverse events: 32 (35%) with 60 events in the high-titre group and 15 (32%) with 28 events in the low-titre group. The most common serious adverse events were acute respiratory distress syndrome (ARDS; four [4%] vs two [4%]), allergic transfusion reactions (two [2%] vs two [4%]), and respiratory distress (three [3%] vs none). 65 (47%) participants experienced 183 adverse events: 42 (46%) with 126 events in the high-titre group and 23 (49%) with 57 events in the low-titre group. The most common adverse events were anaemia (four [3%] vs two [4%]) and ARDS (four [3%] vs three [5%]). Ten patients died during the study (six [7%] in the high-titre group vs four [9%] in the low-titre group, p=0·73). The most common cause of death was worsening of acute respiratory distress syndrome (two [2%] vs two [4%] patients).
INTERPRETATION


High-titre anti-influenza plasma conferred no significant benefit over non-immune plasma. Although our study did not have the precision to rule out a small, clinically relevant effect, the benefit is insufficient to justify the use of immune plasma for treating patients with severe influenza A.
FUNDING


National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Bethesda, MD, USA).",2019,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","['patients with severe influenza A', '200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48', 'patients with severe influenza A infection', '138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen', 'Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible', 'Participants were recruited between Jan 26, 2016, and April 19, 2018']","['interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group', 'intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen', 'Anti-influenza immune plasma', 'standard low-titre plasma']","['anaemia', 'respiratory distress', 'ARDS', 'acute respiratory distress syndrome', 'clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities', 'allergic transfusion reactions', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1283787', 'cui_str': 'Allergic transfusion reaction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.445549,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: jbeigel@niaid.nih.gov.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Aga', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie-Turenne', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josalyn', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tebas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Clark', 'Affiliation': 'Beaumont Hospital-Royal Oak, Royal Oak, MI, USA.'}, {'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Metcalf', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ozment', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kanakatte', 'Initials': 'K', 'LastName': 'Raviprakash', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chorley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30199-7']
344,31829095,"Transplantation efficacy of autologous bone marrow mesenchymal stem cells combined with atorvastatin for acute myocardial infarction (TEAM-AMI): rationale and design of a randomized, double-blind, placebo-controlled, multi-center, Phase II TEAM-AMI trial.","Aim:  To determine the efficacy and safety of intracoronary infusion of autologous bone marrow mesenchymal stem cells (MSC INJ ) in combination with intensive atorvastatin (ATV) treatment for patients with anterior ST-segment elevation myocardial infarction-elevation myocardial infarction.  Patients & methods:  The trial enrolls a total of 100 patients with anterior ST-elevation myocardial infarction. The subjects are randomly assigned (1:1:1:1) to receive routine ATV (20 mg/d) with placebo or MSCs INJ  and intensive ATV (80 mg/d) with placebo or MSCs INJ . The primary end point is the absolute change of left ventricular ejection fraction within 12 months. The secondary end points include parameters in cardiac function, remodeling and regeneration, quality of life, biomarkers and clinical outcomes.  Results & conclusion:  The trial will implicate the essential of cardiac micro-environment improvement ('fertilizing') for cell-based therapy.  Clinical Trial Registration:  NCT03047772.",2019,The trial will implicate the essential of cardiac micro-environment improvement ('fertilizing') for cell-based therapy.  ,"['acute myocardial infarction (TEAM-AMI', 'patients with anterior ST-segment elevation myocardial infarction-elevation myocardial infarction', '100 patients with anterior ST-elevation myocardial infarction']","['autologous bone marrow mesenchymal stem cells combined with atorvastatin', 'placebo or MSCs INJ ', 'intensive atorvastatin (ATV', 'placebo', 'placebo or MSCs INJ  and intensive ATV', 'routine ATV', 'intracoronary infusion of autologous bone marrow mesenchymal stem cells (MSC INJ ']","['Transplantation efficacy', 'absolute change of left ventricular ejection fraction', 'cardiac function, remodeling and regeneration, quality of life, biomarkers and clinical outcomes', 'efficacy and safety']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3874460', 'cui_str': 'Anterior ST segment elevation'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.378072,The trial will implicate the essential of cardiac micro-environment improvement ('fertilizing') for cell-based therapy.  ,"[{'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Pei-Sen', 'Initials': 'PS', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wen-Yang', 'Initials': 'WY', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wen-Xiu', 'Initials': 'WX', 'LastName': 'Leng', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Gui-Hao', 'Initials': 'GH', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Rui-Jie', 'Initials': 'RJ', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Cun-Rong', 'Initials': 'CR', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Meng-Jin', 'Initials': 'MJ', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Nuclear Medicine, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Echocardiography, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of Laboratory Medicine, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research & Biometrics Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Medical Research & Biometrics Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xiang-Feng', 'Initials': 'XF', 'LastName': 'Lu', 'Affiliation': 'Department of Epidemiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Xi-Feng', 'Initials': 'XF', 'LastName': 'Jiang', 'Affiliation': 'Hebei Better Cell Biological Technology Co., Ltd, Hebei 050000, China.'}, {'ForeName': 'Chun-Cheng', 'Initials': 'CC', 'LastName': 'Ma', 'Affiliation': 'Hebei Better Cell Biological Technology Co., Ltd, Hebei 050000, China.'}, {'ForeName': 'Jian-Wen', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'Hebei Better Cell Biological Technology Co., Ltd, Hebei 050000, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Geng', 'Affiliation': 'The Center for Cardiovascular Biology & Atherosclerosis Research, Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, TX 77030, USA.'}, {'ForeName': 'Shu-Bin', 'Initials': 'SB', 'LastName': 'Qiao', 'Affiliation': 'Hebei Better Cell Biological Technology Co., Ltd, Hebei 050000, China.'}, {'ForeName': 'Run-Lin', 'Initials': 'RL', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}, {'ForeName': 'Yue-Jin', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.'}]",Regenerative medicine,['10.2217/rme-2019-0024']
345,31126825,One-year follow-up of a remotely delivered epilepsy self-management program in high-risk people with epilepsy.,"OBJECTIVE


""Self-management for people with epilepsy and a history of negative health events"" (SMART) is a novel group-format epilepsy self-management intervention demonstrated to reduce negative health events (NHEs) such as accidents, emergency department visits, and seizures in adults with epilepsy in a 6-month prospective randomized controlled trial (RCT); SMART also reduced depressive symptoms and improved health functioning and quality of life. This report describes the longer-term (12-month) post-efficacy RCT outcomes in adults with epilepsy who received SMART.
METHODS


After completing a 6-month, prospective RCT that demonstrated efficacy of SMART vs 6-month waitlist control (WL), adults ≥18 years of age with epilepsy were followed for an additional 12 months. Individuals originally randomized to WL received the 8-week SMART intervention immediately following the conclusion of the RCT. For this long-term extension analysis, assessments were conducted at 24 weeks (the 6-month primary outcome time-point of the efficacy RCT), at 32 weeks for individuals originally randomized to WL, and at 48 weeks and 72 weeks for all individuals. Outcomes assessed included past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10).
RESULTS


At the beginning of this long-term observational period (24-week follow-up time point for the original RCT), there were 50 individuals in the group originally randomized to SMART and 52 originally randomized to WL. Mean age was 41.4 years, 70% women (N = 71), 64% (N = 65) African-American, and 8% Hispanic (N = 8). Study attrition from week 24 to week 72 was 8% in the arm originally randomized to SMART and 17% in the arm originally randomized to WL. During the 12-month observation period (24 weeks to 72 weeks), there were a total of 44 serious adverse events and 4 deaths, none related to study participation. There was no significant change in total past 6-month NHE counts in the group originally randomized to SMART, although the group had significantly reduced 6-month seizure counts. The group originally randomized to WL, who received SMART during this observational period, had a reduction in total NHE counts. The group originally randomized to SMART had relatively stable levels on other outcome variables except for a trend for improved MADRS (p = 0.08). In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
CONCLUSIONS


This post-RCT extension study suggests that adults with epilepsy who participate in the SMART intervention sustain clinical effects at 1-year follow-up and may have incremental improvements in seizure frequency and mood. Future research needs to identify opportunities for scale-up and outreach to other high-risk groups with epilepsy.",2019,"In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
","['adults ≥18\u202fyears of age with epilepsy', 'high-risk people with epilepsy', 'Mean age was 41.4\u202fyears, 70% women (N\u202f=\u202f71), 64% (N\u202f=\u202f65) African-American, and 8% Hispanic (N\u202f=\u202f8', 'people with epilepsy and a history of negative health events"" (SMART', 'adults with epilepsy who participate in the', 'adults with epilepsy']","['SMART intervention', 'epilepsy self-management program']","['health functioning and quality of life', 'PHQ-9', 'QOLIE-10', 'total NHE counts', 'past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10', '6-month seizure counts', 'MADRS', 'total past 6-month NHE counts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",,0.104302,"In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: martha.sajatovic@uhhospitals.org.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Colon-Zimmermann', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kahriman', 'Affiliation': 'Department of Neurology, Louis Stokes Cleveland VAMC, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Fuentes-Casiano', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University School of Nursing, Louis Stokes Cleveland VAMC, Cleveland, OH, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Cassidy', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Samden', 'Initials': 'S', 'LastName': 'Lhatoo', 'Affiliation': 'Department of Neurology, University of Texas Houston, Houston, TX, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Einstadter', 'Affiliation': 'Case Western Reserve University and Center for Health Care Research and Policy, MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Louis Stokes Cleveland VAMC, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.04.034']
346,32267058,"Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.","Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are recommended for glycaemic management in patients with type 2 diabetes (T2D). Oral semaglutide, the first oral GLP-1RA, has recently been approved for clinical use, based on the results of the randomized, Phase 3a Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) clinical trials. The PIONEER programme tested oral semaglutide in patients with T2D of duration ranging from 3.5 to 15 years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients. Outcomes (glycated haemoglobin [HbA1c] and body weight reduction, plus other relevant efficacy and safety endpoints) were tested against both placebo and active standard-of-care medications. A separate trial evaluated the cardiovascular safety of oral semaglutide in patients with T2D at high cardiovascular risk. Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose. Oral semaglutide provided significantly better efficacy than placebo and commonly used glucose-lowering medications from the dipeptidyl peptidase-4 inhibitor (sitagliptin) and sodium-glucose co-transporter-2 inhibitor (empagliflozin) classes, as well as the subcutaneous GLP-1RAs liraglutide and dulaglutide. Oral semaglutide was well tolerated in line with the known safety profile of GLP-1RAs, with transient gastrointestinal events being the most common side effects reported. Cardiovascular safety was demonstrated for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk. The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D. The availability of oral semaglutide may help to broaden treatment choice and facilitate adoption of earlier GLP-1RA treatment in the paradigm of T2D management.",2020,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c  and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","['patients with type 2 diabetes (T2D', 'patients with type 2 diabetes', 'patients with cardiovascular disease or high cardiovascular risk', 'patients with T2D at high cardiovascular risk', 'patients with T2D of duration ranging from 3.5 to 15\u2009years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients']","['Glucagon-like peptide-1 receptor agonists (GLP-1RAs', 'once-daily oral semaglutide', 'placebo', 'oral semaglutide']","['Efficacy, safety and cardiovascular outcomes', 'Outcomes (glycated haemoglobin', 'Cardiovascular safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}]",,0.0294568,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c  and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","[{'ForeName': 'Tina K', 'Initials': 'TK', 'LastName': 'Thethi', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Centre Bochum-Hattingen, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14054']
347,32267071,A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience.,"BACKGROUND


Chinese guidelines for the treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycaemic medication (OAM). This pragmatic study compared effectiveness and safety of add-on basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50:50 premixed insulin) as starter insulin regimens in Chinese patients with T2D in a real-world setting.
MATERIALS AND METHODS


This was a multicentre, open-label, randomized, parallel, pragmatic trial. Patients receiving OAMs were randomized 1:1 to BI (n = 410) or MMI (n = 404) for 24 weeks. Insulin titration and OAM adjustment were determined by investigators following usual standard-of-care. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline.
RESULTS


Least-squares mean changes in HbA1c from baseline to week 24 were -2.00% and -2.15% for BI and MMI groups, respectively (P = .13). The MMI group demonstrated a greater reduction in concomitant OAM therapies used than BI group (53.8% vs. 35.3%, respectively; P < .001). Very limited daily insulin dose increments were observed from baseline to week 24 in both BI and MMI groups (2.5 U/day and 1.8 U/day, respectively). Although both insulin analogs were well-tolerated without severe hypoglycaemia, small weight gains were seen with both treatments. Higher total hypoglycaemia rates were noticed with the MMI group, while nocturnal hypoglycaemia events were comparable.
CONCLUSIONS


In real-world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycaemia. The BI group received a greater number of OAMs in real-world settings. Limited insulin dose titration was observed, while more adjustments occurred with OAM usage.",2020,"The MMI group demonstrated greater reduction in concomitant OAM therapies used than BI group (53.8% vs 35.3%, respectively; P < 0.001).","['Patients receiving OAMs', 'Chinese patients with T2D in a real-world setting', 'patients with type 2 diabetes uncontrolled with oral antihyperglycemic medications']","['basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50/50 premixed insulin', 'mid-mixture insulin and basal insulin treatment', 'MMI']","['tolerated without severe hypoglycemia, small weight gains', 'Insulin titration and OAM adjustment', 'glycated hemoglobin (HbA1c', 'concomitant OAM therapies', 'nocturnal hypoglycemia events', 'total hypoglycemia rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0741634,"The MMI group demonstrated greater reduction in concomitant OAM therapies used than BI group (53.8% vs 35.3%, respectively; P < 0.001).","[{'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, First Hospital, affiliate with Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Hubei Provincial, Clinical Research Center for Diabetes and Metabolic Disorders, Tongji Medical College, Union Hospital, Huazhong University of Science and Technology, Wuhan, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14052']
348,31230462,Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated with disruption in social and occupational function. Transcranial magnetic stimulation (TMS) represents a novel approach to PTSD, and intermittent theta-burst stimulation (iTBS) is a new, more rapid administration protocol with data supporting efficacy in depression. The authors conducted a sham-controlled study of iTBS for PTSD.
METHODS


Fifty veterans with PTSD received 10 days of sham-controlled iTBS (1,800 pulses/day), followed by 10 unblinded sessions. Primary outcome measures included acceptability (retention rates), changes in PTSD symptoms (clinician- and self-rated), quality of life, social and occupational function, and depression, obtained at the end of 2 weeks; analysis of variance was used to compare active with sham stimulation. Secondary outcomes were evaluated 1 month after treatment, using mixed-model analyses. Resting-state functional MRI was acquired at pretreatment baseline on an eligible subset of participants (N=26) to identify response predictors.
RESULTS


Retention was high, side effects were consistent with standard TMS, and blinding was successful. At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34). One-month outcomes, which incorporated data from the unblinded phase of the study, indicated superiority of active iTBS on clinician- and self-rated PTSD symptoms (d=-0.74 and -0.63, respectively), depression (d=-0.47), and social and occupational function (d=0.93) (all significant). Neuroimaging indicated that clinical improvement was significantly predicted by stronger (greater positive) connectivity within the default mode network and by anticorrelated (greater negative) cross-network connectivity.
CONCLUSIONS


iTBS appears to be a promising new treatment for PTSD. Most clinical improvements from stimulation occurred early, which suggests a need for further investigation of optimal iTBS time course and duration. Consistent with previous neuroimaging studies of TMS, default mode network connectivity played an important role in response prediction.",2019,"At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34).","['Posttraumatic Stress Disorder', 'Fifty veterans with PTSD received 10 days of', 'Posttraumatic stress disorder (PTSD']","['iTBS', 'Transcranial magnetic stimulation (TMS', 'sham-controlled iTBS', 'Theta-Burst Transcranial Magnetic Stimulation']","['superiority of active iTBS on clinician- and self-rated PTSD symptoms', 'depression (d=-0.47), and social and occupational function', 'improved social and occupational function', 'acceptability (retention rates), changes in PTSD symptoms (clinician- and self-rated), quality of life, social and occupational function, and depression, obtained at the end of 2 weeks; analysis of variance', 'self-reported PTSD symptoms']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0002780', 'cui_str': 'ANOVA'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.0716431,"At 2 weeks, active iTBS was significantly associated with improved social and occupational function (Cohen's d=0.39); depression was improved with iTBS compared with the sham treatment (d=-0.45), but the difference fell short of significance, and moderate nonsignificant effect sizes were observed on self-reported PTSD symptoms (d=-0.34).","[{'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Larson', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'M Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': ""van 't Wout-Frank"", 'Affiliation': 'The Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and the Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, R.I.'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.18101160']
349,32135337,Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects.,"BACKGROUND


Studies assessing the impact of sleep restriction (SR) on blood pressure (BP) are limited by short study length, extreme SR (<4 hours a night), and lack of attention to psychological distress as a possible mediator.
METHODS


A community-based cohort was assembled with 237 women (age 34.1 ± 13.5 years; body mass index 25.4 ± 5.4 kg/m 2 ), and a randomized, crossover, intervention study was conducted in 41 women (24 completed: age 30.2 ± 6.5 years; body mass index 24.3 ± 2.8 kg/m 2 ) to determine the causal effect of SR on BP. Sleep was maintained as usual (HS) or reduced by 1.5 hours a night (SR) for 6 weeks. In the cohort, associations between sleep and psychosocial factors were evaluated using multivariable models adjusted for demographic and clinical confounders. In the intervention study, in-office BP was measured weekly; ambulatory BP was measured at end point. Psychological factors were assessed at baseline and end point. Mixed-model analyses with total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect) were performed.
RESULTS


Among the community cohort, higher perceived stress, stressful events and distress, and lower resilience were associated with shorter sleep, worse sleep quality, and greater insomnia symptoms (P < .05). In the intervention, systolic BP increased as TST decreased (TST × week interaction, [coefficient ± standard error] -0.0097 ± 0.0046, P = .036). Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS. Psychological distress variables were not affected by TST and did not mediate the effects of SR on BP.
CONCLUSIONS


These results suggest that SR influences CVD risk in women via mechanisms independent of psychological stressors.",2020,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","['41 women (24 completed: age 30.2\u202f±\u202f6.5 years; body mass index 24.3\u202f±\u202f2.8 kg/m 2 ', 'premenopausal women with no indication of mediation by psychological effects', 'A community-based cohort was assembled with 237 women (age 34.1\u202f±\u202f13.5 years; body mass index 25.4\u202f±\u202f5.4 kg/m 2 ']","['Mild sleep restriction', 'sleep restriction (SR']","['mean arterial pressure', 'total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect', '24-hour ambulatory blood pressure', 'shorter sleep, worse sleep quality, and greater insomnia symptoms', 'Psychological factors', 'blood pressure (BP', 'Wake ambulatory diastolic blood pressure', 'stress, stressful events and distress', 'ambulatory BP', 'Sleep', 'Psychological distress variables', 'systolic BP increased as TST']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",237.0,0.0291203,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY; Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY. Electronic address: ms2554@cumc.columbia.edu.'}, {'ForeName': 'Ayanna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Aggarwal', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Jasmine L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY; Tulane Medical Center, New Orleans, LA.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Spruill', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.02.006']
350,32246743,Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.,"BACKGROUND


Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling.
METHODS


Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Based on sparse blood sampling, the daily area under the plasma concentration-time curve [AUC (0-24)ss  ] and trough [C trough,ss  ] and maximum [C max,ss  ] steady-state plasma concentrations were derived using population PK modeling. Exposure-response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste-and-texture questionnaire was collected for suspension-recipients.
RESULTS


Of the 335 children (aged 0-17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable.
DISCUSSION


Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.",2020,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","['pediatric venous thromboembolism', 'children with VTE', 'pediatric venous thromboembolism (VTE', '335 children (aged 0-17 years) allocated to']","['Rivaroxaban', 'rivaroxaban']","['Acceptability and palatability', 'individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events', 'plasma concentration-time curve [AUC (0-24)ss  ] and trough [C trough,ss  ] and maximum [C max,ss  ] steady-state plasma concentrations', 'PK parameters with efficacy, bleeding, or adverse event outcomes']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",335.0,0.0324861,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': ""Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.""}, {'ForeName': 'Anthonie W A', 'Initials': 'AWA', 'LastName': 'Lensing', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monagle', 'Affiliation': ""Department of Clinical Haematology, Royal Children's Hospital, Haematology Research Murdoch Children's Research Institute, Parkville, Vic., Australia.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Male', 'Affiliation': 'Department of Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Thelen', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Palumbo', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Riten', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Ildar', 'Initials': 'I', 'LastName': 'Nurmeev', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hege', 'Affiliation': 'Riley Hospital For Children at IU Health, Indianapolis, IN, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Bajolle', 'Affiliation': 'M3C-Necker Enfants malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Connor', 'Affiliation': ""The Noah's Ark Children's Hospital for Wales, Cardiff, UK.""}, {'ForeName': 'Hélène L', 'Initials': 'HL', 'LastName': 'Hooimeijer', 'Affiliation': ""Department of Hematology and Oncology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ""Department of Hematology and Oncology, Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Anthony K C', 'Initials': 'AKC', 'LastName': 'Chan', 'Affiliation': ""McMaster Children's Hospital, Hamilton, ON, Canada.""}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Holzhauer', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Santamaría', 'Affiliation': ""Hemostasis and Thrombosis Unit, Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Amedro', 'Affiliation': 'Paediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Montpellier University Hospital, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Division of Haematology and Haemostaseology, Department of Medicine I, Department of Haematology, University Hospital ""Carl Gustav Carus"" Dresden, King\'s Thrombosis Service, King\'s College London, London, UK.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'M Patricia', 'Initials': 'MP', 'LastName': 'Massicotte', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Smith', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, OR, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Dalhousie University, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14813']
351,30965344,Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome.,"BACKGROUND


In adults with primary focal segmental glomerulosclerosis (FSGS), daily prednisone may induce complete remissions (CR) and partial remissions (PR), but relapses are frequent and adverse events are common.
METHODS


We carried out 2 open-label, uncontrolled trials to explore the efficacy and tolerability of pulse oral dexamethasone as an alternative to daily prednisone. We enrolled adult patients with proteinuria > 3.5 g/day despite the use of renin-angiotensin-aldosterone blockade. In the first trial, we enrolled 14 subjects with FSGS and administered 4 dexamethasone doses (25 mg/m2) daily for 4 days, repeated every 28 days over 32 weeks. The second trial involved a more intensive regimen. Eight subjects received 4 dexamethasone doses of 50 mg/m2 every 4 weeks for 12 weeks, followed by 4 doses of 25 mg/m2 every 4 weeks for 36 weeks; subjects were randomized to 2 doses every 2 weeks or 4 doses every 4 weeks.
RESULTS


In the first trial, we enrolled 13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36%. In the second trial, we enrolled 8 subjects. The combined CR and PR rate was 29%. Analysis combining both trials showed a combined CR and PR rate of 33%. Adverse events were observed in 32% of subjects, with mood symptoms being most common. There were no serious adverse events related to the study.
CONCLUSION


We conclude that high dose oral dexamethasone is well tolerated by adults with idiopathic nephrotic syndrome and may have some efficacy.",2019,"There were no serious adverse events related to the study.
","['enrolled adult patients with proteinuria > 3.5 g/day despite the use of renin-angiotensin-aldosterone blockade', '14 subjects with FSGS and administered 4', 'Adults with Idiopathic Nephrotic Syndrome', 'adults with idiopathic nephrotic syndrome', 'adults with primary focal segmental glomerulosclerosis (FSGS', '13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36']","['Oral Pulse Dexamethasone', 'prednisone', 'dexamethasone']","['combined CR and PR rate', 'Adverse events', 'efficacy and tolerability', 'serious adverse events', 'complete remissions (CR) and partial remissions (PR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3496337', 'cui_str': 'Nephrotic Syndrome, Type 2'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0017668', 'cui_str': 'Glomerulonephritis, Focal Sclerosing'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",14.0,0.0931148,"There were no serious adverse events related to the study.
","[{'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Branton', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Smith', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bartlett', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Reynolds', 'Affiliation': 'Radiology and Imaging Services, Mark O. Hatfield Clinical Research Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Pathology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'M Berenice', 'Initials': 'MB', 'LastName': 'Nava', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barisoni', 'Affiliation': 'Department of Pathology, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Kopp', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA, jbkopp@NIH.gov.'}]",American journal of nephrology,['10.1159/000497064']
352,31860597,Simulated patient-based teaching of medical students improves pre-anaesthetic assessment: A rater-blinded randomised controlled trial.,"BACKGROUND


Pre-anaesthetic assessment of patients is a complex competency that needs to be taught during anaesthesia clerkships.
OBJECTIVES


We aimed to improve student teaching and investigated the effectiveness of trained 'simulated patients' (lay persons or actors trained to portray specific roles or symptoms) in the teaching of medical students to perform routine pre-anaesthetic assessments. We hypothesised that the intervention of one 30-min teaching sequence with a simulated patient will improve the performance of year 4 medical students in pre-anaesthesia assessment of elective surgical patients, compared with the control of standard apprentice-based teaching.
DESIGN


Randomised controlled trial.
SETTING/PARTICIPANTS


One hundred and forty-four year 4 medical students at the University of Bern.
INTERVENTION


These students were randomised to either the standard clinician-supervised learning in the operating theatre (n=71; control group) or a single teaching session with a simulated patient (nonhealthcare provider, as a trained layperson) (n=73; intervention group). Both groups of students then performed pre-anaesthetic patient visits. The student performances during these visits were assessed according to the mini-Clinical Evaluation Exercise tool by trained anaesthesiologists blinded to randomisation. The 71 students in the standard clinical supervision group also underwent the simulated patient teaching session on the day following the assessments.
RESULTS


The students in the intervention group of simulated patient teaching scored significantly higher in both their mini-Clinical Evaluation Exercise overall impression scores (8.8 ± 0.8 vs. 8.3 ± 0.9; P = 0.004) and mean domain scores (8.7 ± 0.8 vs. 8.3 ± 0.9; P = 0.01), compared with those of the control group with the standard clinical supervision.
CONCLUSION


The current single teaching encounter with a trained layperson acting as a simulated patient improved medical student performances in their pre-anaesthetic clinical assessment of surgical patients. This might be a suitable alternative to reduce the teaching burden for busy and costly clinicians.",2020,"The students in the intervention group of simulated patient teaching scored significantly higher in both their mini-Clinical Evaluation Exercise overall impression scores (8.8 ± 0.8 vs. 8.3 ± 0.9; P = 0.004) and mean domain scores (8.7 ± 0.8 vs. 8.3 ± 0.9; P = 0.01), compared with those of the control group with the standard clinical supervision.
","['surgical patients', 'One hundred and forty-four year 4 medical students at the University of Bern', '71 students in the standard clinical supervision group also underwent the']","['simulated patient teaching session', ""trained 'simulated patients' (lay persons or actors trained to portray specific roles or symptoms"", 'Simulated patient-based teaching', 'control of standard apprentice-based teaching', 'standard clinician-supervised learning in the operating theatre (n=71; control group) or a single teaching session with a simulated patient (nonhealthcare provider, as a trained layperson']","['mini-Clinical Evaluation Exercise overall impression scores', 'medical student performances', 'mean domain scores']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0335083', 'cui_str': 'Actor (occupation)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.0650957,"The students in the intervention group of simulated patient teaching scored significantly higher in both their mini-Clinical Evaluation Exercise overall impression scores (8.8 ± 0.8 vs. 8.3 ± 0.9; P = 0.004) and mean domain scores (8.7 ± 0.8 vs. 8.3 ± 0.9; P = 0.01), compared with those of the control group with the standard clinical supervision.
","[{'ForeName': 'Joana M', 'Initials': 'JM', 'LastName': 'Berger-Estilita', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Inselspital Bern University Hospital (JMB-E, RG) and Institute of Medical Education (CB, DS, KPS), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Berendonk', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stricker', 'Affiliation': ''}, {'ForeName': 'Kai P', 'Initials': 'KP', 'LastName': 'Schnabel', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001139']
353,31860599,The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial.,"BACKGROUND


Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most complex gastrointestinal endoscopic procedures. Currently, it is still unclear which sedation regimen best facilitates an ERCP. The N-methyl-D-aspartate receptor antagonist esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less cardiorespiratory depression than other sedatives. It could therefore be an ideal adjunct to propofol for deep sedation.
OBJECTIVE


To assess the effectiveness of esketamine versus alfentanil as an adjunct to propofol target-controlled infusion (TCI) for deep sedation during ambulant ERCP.
DESIGN


A randomised controlled multicentre study.
SETTING


Endoscopic intervention suite at an academic and general hospital in the Netherlands.
PARTICIPANTS


Adult, American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo ERCP.
INTERVENTION


Consecutive patients were randomly assigned to receive sedation for an ERCP with propofol TCI and alfentanil (group A) or with propofol TCI and esketamine (group E).
MAIN OUTCOME MEASURES


The primary outcome was effectiveness of the sedation regimen expressed as the total dose of propofol - as a surrogate parameter - necessary to perform ERCP in a satisfactory manner for endoscopist and patients. Secondary outcomes were recovery time, patients' and endoscopists' satisfaction with sedation, side effects (e.g. psychotomimetic effects, nausea and vomiting) and the number of respiratory and cardiovascular adverse events.
RESULTS


Data from 162 patients were analysed. The total dose of propofol required was significantly lower in group E (n=83) (8.3 mg kg h) than in group A (n=79) (10.5 mg kg h) (P < 0.001). There were no significant differences in recovery time, patients' and endoscopists' satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events.
CONCLUSION


Low-dose esketamine reduces the total amount of propofol necessary for sedation during ERCP in American Society of Anesthesiologists I and II patients without affecting recovery time, satisfaction of patients and endoscopists, side effects and respiratory or cardiovascular adverse events, when compared with alfentanil.
TRIAL REGISTRATION


The Netherlands Trial Register (NTR5486).",2020,"There were no significant differences in recovery time, patients' and endoscopists' satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events.
","['Consecutive patients', 'endoscopic retrograde cholangiopancreatography', 'Adult, American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo ERCP', 'Endoscopic intervention suite at an academic and general hospital in the Netherlands', 'Data from 162 patients were analysed']","['Endoscopic retrograde cholangiopancreatography (ERCP', 'low-dose esketamine', 'propofol target-controlled infusion (TCI', 'propofol', 'ERCP with propofol TCI and alfentanil (group A) or with propofol TCI and esketamine (group E', 'alfentanil adjunct to propofol sedation', 'esketamine versus alfentanil']","[""recovery time, patients' and endoscopists' satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events"", 'total dose of propofol - as a surrogate parameter - necessary to perform ERCP', ""recovery time, patients' and endoscopists' satisfaction with sedation, side effects (e.g. psychotomimetic effects, nausea and vomiting) and the number of respiratory and cardiovascular adverse events""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C2825616'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",162.0,0.11232,"There were no significant differences in recovery time, patients' and endoscopists' satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events.
","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'From the Department of Anesthesiology (SE, LK, JH, MWH, BP), Department of Gastroenterology & Hepatology, Amsterdam University Medical Centers, Location AMC, University of Amsterdam, Amsterdam (JvH) and Department of Anesthesiology, Tjongerschans Ziekenhuis, Heerenveen, The Netherlands (EdJ).'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Koers', 'Affiliation': ''}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'van Hooft', 'Affiliation': ''}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'de Jong', 'Affiliation': ''}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hermanides', 'Affiliation': ''}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': ''}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001134']
354,31503037,Effects of depth of neuromuscular block on postoperative pain during laparoscopic gastrectomy: A randomised controlled trial.,"BACKGROUND


Evidence on whether the use of deep neuromuscular block (NMB) influences postoperative pain after laparoscopic surgery is limited, and existing studies have shown conflicting results. We studied the effect of the depth of NMB during laparoscopic gastrectomy on postoperative pain.
OBJECTIVE


The aim of this study was to evaluate the effect of depth of NMB during laparoscopic gastrectomy on postoperative pain by allocating patients randomly to either deep or moderate NMB with a standard-pressure pneumoperitoneum.
DESIGN


A randomised, controlled, double-blind study.
SETTING


A university-affiliated hospital.
PARTICIPANTS


One hundred patients.
INTERVENTIONS


Patients were allocated randomly to receive either deep (posttetanic count 1 to 2) or moderate (train-of-four count 1 to 2) levels of NMB. Following surgery, the patients were asked to rate their pain every 10 min using a visual analogue scale (VAS) (0 = no pain, 10 = most severe pain) in the postanaesthesia care unit (PACU). Patients received intravenous oxycodone, 2 mg every 10 min, until the pain intensity (VAS) had decreased to less than 3 at rest and less than 5 on wound compression, at which point the minimum effective analgesia dose (MEAD) of oxycodone was determined.
MAIN OUTCOME MEASURES


The primary endpoint was the MEAD of oxycodone. Secondary endpoints included area under the curve of VAS for wound pain, VAS scores for wound and shoulder pain at 6 and 24 h after the end of surgery, rescue analgesics, a five-point surgical rating scale, Rhodes index of nausea vomiting retching at 6 and 24 h after the end of surgery and duration of pneumoperitoneum.
RESULTS


The median value for the MEAD of oxycodone was 8 mg in both groups. Area under the curves of VAS over time were similar in both groups. Variables associated with postoperative pain including mean VAS at PACU and frequency of rescue analgesics in the ward did not differ significantly between the two groups. The duration of pneumoperitoneum was a significant variable in determining the MEAD of oxycodone (linear regression, R = 0.07, P = 0.008). The number of patients who reached the acceptable surgical score was not significantly different between the two groups. However, the moderate NMB group did have a significantly higher proportion of cases that required additional muscle relaxants (P < 0.001).
CONCLUSION


Deep, compared with moderate, NMB did not significantly reduce the MEAD of oxycodone administered in the PACU. The duration of pneumoperitoneum was positively correlated with the MEAD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03266419.",2019,Variables associated with postoperative pain including mean VAS at PACU and frequency of rescue analgesics in the ward did not differ significantly between the two groups.,"['postoperative pain by allocating patients randomly to either deep or moderate NMB with a standard-pressure pneumoperitoneum', 'A university-affiliated hospital', 'One hundred patients']","['laparoscopic gastrectomy', 'deep neuromuscular block (NMB', 'intravenous oxycodone', 'neuromuscular block', 'NMB', 'oxycodone']","['postoperative pain', 'acceptable surgical score', 'visual analogue scale (VAS', 'area under the curve of VAS for wound pain, VAS scores for wound and shoulder pain at 6 and 24\u200ah after the end of surgery, rescue analgesics, a five-point surgical rating scale, Rhodes index of nausea vomiting retching', 'postoperative pain including mean VAS at PACU and frequency of rescue analgesics', 'duration of pneumoperitoneum', 'MEAD of oxycodone']","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0241745', 'cui_str': 'Wound pain (finding)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0222045'}, {'cui': 'C0454812', 'cui_str': 'Rhodes (geographic location)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]",100.0,0.283028,Variables associated with postoperative pain including mean VAS at PACU and frequency of rescue analgesics in the ward did not differ significantly between the two groups.,"[{'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul (C-BM, L-YH, N-GJ), Department of Anesthesiology and Pain Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan (K-SH), Department of Surgery (G-CS, K-HS, L-IS, K-BuS, K-ByS) and Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea (N-GJ).'}, {'ForeName': 'Seung-Hee', 'Initials': 'SH', 'LastName': 'Ki', 'Affiliation': ''}, {'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Hee-Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'In-Seob', 'Initials': 'IS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Beom-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Byung-Sik', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Gyu-Jeong', 'Initials': 'GJ', 'LastName': 'Noh', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001082']
355,31195326,"A randomized, open-label, multicenter comparative trial of levetiracetam and topiramate as adjunctive treatment for patients with focal epilepsy in Korea.","OBJECTIVE


The objective of this trial was to compare the effectiveness of levetiracetam (LEV) and topiramate (TPM) as adjunctive treatment for patients with focal seizures in Korea.
METHODS


In this Phase IV, open-label, multicenter trial (NCT01229735), adults were randomized to treatment with LEV (1000-3000 mg/day) or TPM (200-400 mg/day). Only patients achieving LEV ≥1000 mg/day or TPM ≥100 mg/day after a 4-week up-titration entered the 20-week dose-finding and subsequent 28-week maintenance periods. The primary outcome was the 52-week retention rate; others included safety and exploratory efficacy outcomes.
RESULTS


Of 343 randomized patients (LEV 177; TPM 166), 211 (61.5%) completed the trial. In the full analysis set (FAS), retention rate was 59.1% with LEV vs 56.6% with TPM (p = 0.7007), while in the prespecified sensitivity analysis, based on data from patients who received drug doses in the recommended range (LEV 176; TPM 113), it was 59.1% with LEV vs 42.5% with TPM (p = 0.0086). In the FAS, median percent reduction in seizure frequency from baseline was 74.47% with LEV and 67.86% with TPM (p = 0.0665); ≥50% responder rate was 69.0% vs 64.8% (p = 0.4205), and the 6-month seizure-freedom rate was 35.8% vs 22.3% (p = 0.0061). In the sensitivity analysis, differences between groups were greater, favoring LEV. Incidences of treatment-emergent adverse events (TEAEs) were 70.6% with LEV vs 77.1% with TPM; most frequently somnolence (20.3%), dizziness (18.1%), and nasopharyngitis (13.6%) with LEV; and decreased appetite (15.7%), dizziness (14.5%), and headache (14.5%) with TPM. Discontinuations due to TEAEs were 7.9% with LEV and 12.7% with TPM.
CONCLUSIONS


In this open-label trial, the 52-week retention rate was not significantly different between LEV and TPM. However, LEV was associated with a substantially higher seizure freedom rate and a more favorable safety profile than TPM in this population of Korean patients with focal seizures.",2019,"In the FAS, median percent reduction in seizure frequency from baseline was 74.47% with LEV and 67.86% with TPM (p = 0.0665); ≥50% responder rate was 69.0% vs 64.8% (p = 0.4205), and the 6-month seizure-freedom rate was 35.8% vs 22.3% (p = 0.0061).","['343 randomized patients', 'patients with focal epilepsy in Korea', 'Korean patients with focal seizures', 'patients with focal seizures in Korea']","['levetiracetam (LEV) and topiramate (TPM', 'LEV', 'levetiracetam and topiramate', 'TPM']","['responder rate', '6-month seizure-freedom rate', 'dizziness', 'nasopharyngitis', 'headache', 'retention rate', 'appetite', 'seizure frequency', '52-week retention rate; others included safety and exploratory efficacy outcomes', 'somnolence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014547', 'cui_str': 'Focal Seizure Disorder'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",343.0,0.0677753,"In the FAS, median percent reduction in seizure frequency from baseline was 74.47% with LEV and 67.86% with TPM (p = 0.0665); ≥50% responder rate was 69.0% vs 64.8% (p = 0.4205), and the 6-month seizure-freedom rate was 35.8% vs 22.3% (p = 0.0061).","[{'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Ahm', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loesch', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pelgrims', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Osakabe', 'Affiliation': 'UCB Pharma, Tokyo, Japan.'}, {'ForeName': 'Byungin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Injie University Haeundae Paik Hospital, Busan, Republic of Korea. Electronic address: bilee@paik.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.05.014']
356,31753745,Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial.,"OBJECTIVE


To compare post-operative compression with no compression, after radiofrequency endothermal ablation (RFA) of a truncal varicose vein and concomitant foam sclerotherapy of the tributaries.
METHODS


This prospective randomised controlled, non-inferiority trial recruited patients from two centres in Northern Ostrobothnia, Finland. Patients with clinical class C2-C4 chronic venous disease were randomised to receive no compression after the operation, or to receive compression stockings continuously for two days, and then, during the daytime for five days. In follow up visits, additional foam sclerotherapy was performed for symptoms of distal incompetence. Patients were followed up for six months. The primary outcome was occlusion of the RFA treated truncal vein at six months. Secondary outcomes were return to full activity within 14 days, Aberdeen Varicose Vein Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications.
RESULTS


Of 177 included patients, 90 were allocated to post-operative compression and 87 to no compression. At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042). Within 14 days of treatment, full physical activity was achieved by 87% of the compression group and 81% of the no compression group, (p = .29). At six months, the AVVQ scores were comparable and significantly improved in both groups, compared with baseline. Pain scores were comparable between groups, in day to day analyses, and they were significantly lower in both groups on day 10, compared with pre-operative pain caused by varicose veins. On average, post-operative pain medication was used for 2.3 days and for 2.8 days in the compression and no compression groups, respectively (p = .28). Complications throughout the six month follow up were comparable between groups, although skin rash/blisters occurred more often in the compression group (p = .01).
CONCLUSION


After treating C2-C4 varicose veins with RFA and concomitant foam sclerotherapy, no post-operative compression was non-inferior to post-operative compression, in terms of safety and efficacy. ClinicalTrials.gov Identifier: NCT02890563.",2020,"At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042).","['Of 177 included patients', 'non-inferiority trial recruited patients from two centres in Northern Ostrobothnia, Finland', 'Patients with clinical class C2-C4 chronic venous disease', 'Varicose Veins']","['RFA and concomitant foam sclerotherapy', 'Post-procedural Compression vs. No Compression', 'radiofrequency endothermal ablation (RFA', 'Radiofrequency Ablation and Concomitant Foam Sclerotherapy', 'compression stockings']","['occlusion of the RFA treated truncal vein', 'occlusion rates', 'full physical activity', 'AVVQ scores', 'return to full activity within 14 days, Aberdeen Varicose Vein Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications', 'Pain scores', 'skin rash/blisters', 'Complications', 'safety and efficacy']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042345', 'cui_str': 'Varices'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0038348', 'cui_str': 'Compression Stockings'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.120285,"At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042).","[{'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Pihlaja', 'Affiliation': 'Department of Vascular Surgery, Oulu University Hospital, Finland; Medical Research Centre Oulu, University of Oulu, Oulu, Finland. Electronic address: toni.pihlaja@ppshp.fi.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Romsi', 'Affiliation': 'Department of Vascular Surgery, Oulu University Hospital, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Centre Oulu, University of Oulu, Oulu, Finland; Division of Operative Care, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Jounila', 'Affiliation': 'Department of Surgery, Raahe Regional Hospital, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Pokela', 'Affiliation': 'Department of Vascular Surgery, Oulu University Hospital, Finland.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2019.08.020']
357,32216032,Low doses of recombinant human erythropoietin does not affect C-terminal FGF23 in healthy men.,"Recombinant human erythropoietin (rhEpo) can improve human performance, but misuse remains difficult to detect. C-terminal fibroblast growth factor 23 (cFGF23) was recently demonstrated to increase following injection of a single high dose rhEpo, but the effect of more frequent low doses is unknown. Using a randomized double-blind placebo-controlled design, we investigated whether 2 weeks of subcutaneous injections three times a week of 50 IU/kg Eprex (low-dose) or 20 IU/kg Eprex (micro-dose) increase cFGF23 levels compared with saline (placebo) injections in 24 healthy males. Venous blood was sampled at day -3, 0, 1, 3, 11, 14, 18, and 25 of the treatment and analyzed for cFGF23 and erythropoietin concentration ([EPO]). The level of cFGF23 was similar at days -3, 0, 1, 3, 11, 14, 18, and 25 with the low-dose (23 ± 4, 26 ± 5, 23 ± 7, 27 ± 6, 25 ± 8, 24 ± 10, 22 ± 5, and 24 ± 7 RU/mL, respectively), micro-dose (23 ± 6, 25 ± 5, 23 ± 8, 28 ± 9, 27 ± 7, 25 ± 9, 25 ± 5, and 23 ± 6 RU/mL, respectively) and placebo (23 ± 6, 24 ± 6, 26 ± 7, 26 ± 6, 31 ± 6, 31 ± 7, 24 ± 4, and 27 ± 8 RU/mL, respectively) treatment. The correlation coefficient between plasma [EPO] and plasma cFGF23 levels was R 2  = 0.01 and insignificant. The results demonstrate that cFGF23 is not sensitive to low doses of subcutaneous rhEpo injections in healthy males.",2020,Eprex (micro-dose) increase cFGF23 levels compared with saline (placebo) injections in 24 healthy males.,"['24 healthy males', 'healthy males', 'healthy men']","['Recombinant human erythropoietin (rhEpo', 'saline (placebo) injections', 'cFGF23', 'placebo', 'recombinant human erythropoietin']","['cFGF23 and erythropoietin concentration ([EPO', 'cFGF23 levels', 'level of cFGF23', 'plasma [EPO] and plasma cFGF23 levels', 'Venous blood']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}]",,0.297377,Eprex (micro-dose) increase cFGF23 levels compared with saline (placebo) injections in 24 healthy males.,"[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Robach', 'Affiliation': 'National School of Mountain Sports, Chamonix, France.'}, {'ForeName': 'Anne-Kristine', 'Initials': 'AK', 'LastName': 'Lundby', 'Affiliation': 'Center for Physical Activity Research, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cornu', 'Affiliation': 'Hospices Civils de Lyon INSERM CIC1407/UMR5558, Hôspital Louis Pradel, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sallet', 'Affiliation': 'Association Athletes For Transparency, Lyon, France.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Cairo', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Italy.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lundby', 'Affiliation': 'Center for Physical Activity Research, University Hospital of Copenhagen, Copenhagen, Denmark.'}]",Drug testing and analysis,['10.1002/dta.2795']
358,32217365,PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure: Results of the PRIME-HF Trial.,"BACKGROUND


Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HF patients.
METHODS


PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension).
RESULTS


Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05).
CONCLUSIONS


Ivabradine initiation prior to discharge among stabilized HF patients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.",2020,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","['Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min', '104 patients (36% women, 64% African American', 'patients with stable chronic HF with reduced ejection fraction (EF', 'stabilized acute HF patients', 'Heart Failure']","['ivabradine versus usual care', 'Ivabradine', 'ivabradine']","['safety events', 'heart failure (HF) hospitalization', 'proportion of patients on ivabradine', 'heart rate', 'heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.204552,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gudaye', 'Initials': 'G', 'LastName': 'Tasissa', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Cole', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Mahazarin', 'Initials': 'M', 'LastName': 'Ginwalla', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Old', 'Affiliation': 'Sentara Cardiovascular Research Institute, Norfolk, VA.'}, {'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Salacata', 'Affiliation': 'Great Lakes Heart Center of Alpena, Alpena, MI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bigelow', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2019.12.024']
359,32203696,"Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial.","BACKGROUND


BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years.
METHODS


The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236.
FINDINGS


Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy.
INTERPRETATION


Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending.
FUNDING


National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.",2020,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"['Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ', 'non-low-risk ductal carcinoma', '396 of 1208 women were assigned to category A', '118 hospitals in 11 countries', 'patients with non-low-risk ductal carcinoma', '1098 (91%) of 1208 patients', 'Between June 1, 2007, and Aug 14, 2013, 1208 women']","['minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost', 'conventional whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost', 'category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost', 'Conventional whole breast radiotherapy', 'tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy', 'no tumour bed boost (n=605) or tumour bed boost', 'breast-conserving surgery and whole breast radiotherapy', 'conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy', 'breast-conserving therapy and adjuvant radiotherapy']","['physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question', 'Cosmetic status', 'HRQOL', 'health-related quality of life (HRQOL', 'shoulder function', 'time to local recurrence', 'Quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002045'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0085415'}, {'cui': 'C0222045'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",1208.0,0.212892,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"[{'ForeName': 'Madeleine T', 'Initials': 'MT', 'LastName': 'King', 'Affiliation': 'Faculty of Science, School of Psychology, The University of Sydney, Sydney, NSW, Australia. Electronic address: madeleine.king@sydney.edu.au.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Link', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ivo A', 'Initials': 'IA', 'LastName': 'Olivotto', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kunkler', 'Affiliation': 'Edinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Antonia Helen', 'Initials': 'AH', 'LastName': 'Westenberg', 'Affiliation': 'Radiotherapiegroep Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Behavioural Sciences Unit, Department of Cancer Experiences Research, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia; Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, VIC, Australia.'}, {'ForeName': 'Boon H', 'Initials': 'BH', 'LastName': 'Chua', 'Affiliation': 'University of New South Wales, UNSW Medicine, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30085-1']
360,31335447,"Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study.","BACKGROUND


Epidural analgesia may change the mechanics of childbirth. These changes are related to the concentration of the local anaesthetic used epidurally but probably also to its mode of delivery into the epidural space.
OBJECTIVE


To determine whether the administration of programmed intermittent epidural boluses (PIEB) improves the mechanics of second-stage labour compared with patient-controlled epidural analgesia (PCEA) with a background infusion.
DESIGN


A randomised, controlled, triple-blind study.
SETTING


Multicentre study including four level III maternity units, January 2014 until June 2016.
PATIENTS


A total of 298 nulliparous patients in spontaneous labour were randomised to a PIEB or PCEA group.
INTERVENTION


After epidural initiation with 15 ml of 0.1% levobupivacaine containing 10 μg of sufentanil, patients received either an hourly bolus of 8 ml (PIEB) or a continuous rate infusion of 8 ml h (PCEA): the drug mixture used was levobupivacaine 0.1% and sufentanil 0.36 μg ml.
MAIN OUTCOME MEASURES


The primary outcome was a composite endpoint of objective labour events: a posterior occiput position in the second stage, an occiput position at birth, waiting time at full cervical dilatation before active maternal pushing more than 3 h, maternal active pushing duration more than 40 min, and foetal heart rate alterations. Vaginal instrumental delivery rates, analgesia and motor blockade scores were also recorded.
RESULTS


From the 298 patients randomised, data from 249 (124 PIEB, 125 PCEA) were analysed. No difference was found in the primary outcome: 48.0% (PIEB) and 45.5% (PCEA) of patients, P = 0.70. In addition, no difference was observed between the groups for each of the individual events of the composite endpoint, nor in the instrumental vaginal delivery rate, nor in the degree of motor blockade. Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04.
CONCLUSION


The mechanics of the second stage did not differ whether PIEB or PCEA was used. Analgesic conditions appeared to be superior with PIEB, especially at full dilation.
TRIAL REGISTRATION


NCT01856166.",2019,"Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04.
","['298 nulliparous patients in spontaneous labour', 'Multicentre study including four level III maternity units, January 2014 until June 2016', '298 patients randomised, data from 249 (124 PIEB, 125 PCEA) were analysed', 'nulliparous women']","['levobupivacaine', 'patient-controlled epidural analgesia (PCEA', 'PIEB or PCEA', 'levobupivacaine 0.1% and sufentanil 0.36\u200aμg\u200aml', 'programmed intermittent epidural boluses (PIEB', 'sufentanil']","['Vaginal instrumental delivery rates, analgesia and motor blockade scores', 'childbirth conditions', 'analgesia score at full dilatation', 'instrumental vaginal delivery rate', 'degree of motor blockade', 'composite endpoint of objective labour events: a posterior occiput position in the second stage, an occiput position at birth, waiting time at full cervical dilatation before active maternal pushing more than 3\u200ah, maternal active pushing duration more than 40\u200amin, and foetal heart rate alterations']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079103', 'cui_str': 'Cervical Dilatation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}]",298.0,0.439739,"Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04.
","[{'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Morau', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Hopital Universitaire Arnaud de Villeneuve, Montpellier (EM, MJ, CD), Department of Anesthesiology and Critical Care Medicine Pôle Anesthesie-Reanimation-Estaing, Clermont-Ferrand (BS, MB), Clinical Research and Epidemiology Unit, Medical Information Department, Hopital Universitaire Montpellier, Montpellier (EN, NN), Department of Anesthesiology and Intensive Care, Hopital Universitaire Femme Me[Combining Grave Accent]re Enfant, Hospices Civils de Lyon, Lyon (DC) and Department of Anesthesiology and Critical Care Medicine, Hopitaux Universitaires Paris-Sud, AP-HP, Paris, France (DB).'}, {'ForeName': 'Malaury', 'Initials': 'M', 'LastName': 'Jaillet', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Storme', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nogue', 'Affiliation': ''}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bonnin', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dadure', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001053']
361,31397702,Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study.,"BACKGROUND


The costoclavicular brachial plexus block (BPB) produces faster onset of sensory motor blockade than the lateral sagittal approach. However, the incidence of phrenic nerve palsy (PNP) after a costoclavicular BPB is not known.
OBJECTIVES


The current study compared the incidence of ipsilateral hemidiaphragmatic paresis, and thus PNP, between a supraclavicular and costoclavicular BPB.
DESIGN


Randomised observer blinded study.
SETTING


Operating room.
PATIENTS


Forty patients undergoing right-sided upper extremity surgery.
INTERVENTION


All patients received either a supraclavicular group or costoclavicular group BPB using 20 ml of an equal mixture of 0.5% bupivacaine and 2% lidocaine with 1 : 200 000 epinephrine.
MAIN OUTCOME MEASURES


Measurements included ipsilateral hemidiaphragmatic excursion and peak expiratory flow rate (PEFR) taken before and at 30 min after the BPB. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. Ipsilateral PNP was defined as a reduction in hemidiaphragmatic excursion by at least 50% during deep breathing at 30 min after the BPB.
RESULTS


The incidence of ipsilateral PNP was lower (P = 0.008) in the costoclavicular group (5%) than in the supraclavicular group (45%). Fewer (P = 0.04) patients in the costoclavicular group [1(5%)] exhibited a positive sniff test, with paradoxical movement of the diaphragm, than in the supraclavicular group [7(35%)]. PEFRs were similar (P = 0.09) between the groups. When ipsilateral hemidiaphragmatic paresis was present, the median reduction in PEFR was 32% (interquartile range 23.6 to 45.5%).
CONCLUSION


Costoclavicular BPB produces a lower incidence of ipsilateral PNP than a supraclavicular BPB.
NAME OF REGISTRY


Clinical Trial Registry of India.
IDENTIFIER


CTRI/2017/09/009763.",2019,The incidence of ipsilateral PNP was lower (P = 0.008) in the costoclavicular group (5%) than in the supraclavicular group (45%).,['Forty patients undergoing right-sided upper extremity surgery'],"['supraclavicular group or costoclavicular group BPB using 20\u200aml of an equal mixture of 0.5% bupivacaine and 2% lidocaine with 1\u200a:\u200a200\u200a000 epinephrine', 'costoclavicular brachial plexus block (BPB']","['ipsilateral hemidiaphragmatic excursion and peak expiratory flow rate (PEFR', 'Ipsilateral hemidiaphragmatic paresis', 'PEFRs', 'median reduction in PEFR', 'positive sniff test, with paradoxical movement of the diaphragm', 'hemidiaphragmatic excursion', 'Diaphragmatic excursion', 'incidence of ipsilateral PNP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0030552', 'cui_str': 'Muscular Paresis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0430738', 'cui_str': 'Amine test (procedure)'}, {'cui': 'C0205310', 'cui_str': 'Paradoxical (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",40.0,0.0958922,The incidence of ipsilateral PNP was lower (P = 0.008) in the costoclavicular group (5%) than in the supraclavicular group (45%).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sivashanmugam', 'Affiliation': 'From the Department of Anesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Pillayarkuppam, Pondicherry, India (TS, IM, NK) and Department of Anaesthesia & Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China (MKK).'}, {'ForeName': 'Indubala', 'Initials': 'I', 'LastName': 'Maurya', 'Affiliation': ''}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Karmakar', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001069']
362,32266380,A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia.,"Essential thrombocythemia (ET) is characterized by abnormal megakaryopoiesis and enhanced thrombotic risk. Once-daily low-dose aspirin is the recommended antithrombotic regimen, but accelerated platelet generation may reduce the duration of platelet cyclooxygenase-1 (COX-1) inhibition. We performed a multicenter double-blind trial to investigate the efficacy of 3 aspirin regimens in optimizing platelet COX-1 inhibition while preserving COX-2-dependent vascular thromboresistance. Patients on chronic once-daily low-dose aspirin (n = 245) were randomized (1:1:1) to receive 100 mg of aspirin 1, 2, or 3 times daily for 2 weeks. Serum thromboxane B2 (sTXB2), a validated biomarker of platelet COX-1 activity, and urinary prostacyclin metabolite (PGIM) excretion were measured at randomization and after 2 weeks, as primary surrogate end points of efficacy and safety, respectively. Urinary TX metabolite (TXM) excretion, gastrointestinal tolerance, and ET-related symptoms were also investigated. Evaluable patients assigned to the twice-daily and thrice-daily regimens showed substantially reduced interindividual variability and lower median (interquartile range) values for sTXB2 (ng/mL) compared with the once-daily arm: 4 (2.1-6.7; n = 79), 2.5 (1.4-5.65, n = 79), and 19.3 (9.7-40; n = 85), respectively. Urinary PGIM was comparable in the 3 arms. Urinary TXM was reduced by 35% in both experimental arms. Patients in the thrice-daily arm reported a higher abdominal discomfort score. In conclusion, the currently recommended aspirin regimen of 75 to 100 once daily for cardiovascular prophylaxis appears to be largely inadequate in reducing platelet activation in the vast majority of patients with ET. The antiplatelet response to low-dose aspirin can be markedly improved by shortening the dosing interval to 12 hours, with no improvement with further reductions (EudraCT 2016-002885-30).",2020,"Evaluable patients assigned to the bid and tid regimens showed substantially reduced inter-individual variability and lower median values of sTXB2: 19.3[9.7-40], 4 [2.1-6.7], and 2.5[1.4-5.65] ng/ml in the od (n=85), bid (n=79) and tid (n=79) arms, respectively.","['Two-hundred-forty-five patients on chronic od low-dose', 'essential thrombocythemia']",['aspirin'],"['Urinary TXM', 'platelet activation', 'Serum thromboxane B2 (sTXB2', 'reduced inter-individual variability and lower median values of sTXB2', 'abdominal discomfort score', 'platelet COX-1 activity, and urinary prostacyclin metabolite (PGIM) excretion', 'Urinary PGIM', 'Urinary TX metabolite (TXM) excretion, gastrointestinal tolerance, and ET-related symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040028', 'cui_str': 'Essential thrombocythemia'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C1565830', 'cui_str': 'PTGS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.167227,"Evaluable patients assigned to the bid and tid regimens showed substantially reduced inter-individual variability and lower median values of sTXB2: 19.3[9.7-40], 4 [2.1-6.7], and 2.5[1.4-5.65] ng/ml in the od (n=85), bid (n=79) and tid (n=79) arms, respectively.","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Rocca', 'Affiliation': 'Section of Pharmacology, Catholic University School of Medicine, Rome, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Hematology Department, Ospedale San Bortolo, Vicenza, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Betti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Soldati', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrucci', 'Affiliation': 'Section of Pharmacology, Catholic University School of Medicine, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Timillero', 'Affiliation': 'Hematology Project Foundation, Vicenza, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Cavalca', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Porro', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Iurlo', 'Affiliation': ""Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Cattaneo', 'Affiliation': ""Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bucelli', 'Affiliation': ""Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Dragani', 'Affiliation': 'Hematology Department, S. Spirito Hospital, Pescara, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Di Ianni', 'Affiliation': 'Hematology Department, S. Spirito Hospital, Pescara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ranalli', 'Affiliation': 'Hematology Department, S. Spirito Hospital, Pescara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Palandri', 'Affiliation': 'Institute of Hematology ""L. and A. Seràgnoli,"" S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vianelli', 'Affiliation': 'Institute of Hematology ""L. and A. Seràgnoli,"" S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Beggiato', 'Affiliation': 'Unit of Hematology, Department of Oncology, University of Torino, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lanzarone', 'Affiliation': 'Unit of Hematology, Department of Oncology, University of Torino, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruggeri', 'Affiliation': 'Hematology Department, Ospedale San Bortolo, Vicenza, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Carli', 'Affiliation': 'Hematology Department, Ospedale San Bortolo, Vicenza, Italy.'}, {'ForeName': 'Elena Maria', 'Initials': 'EM', 'LastName': 'Elli', 'Affiliation': 'Division of Haematology and Bone Marrow Transplantation Unit, Ospedale San Gerardo, Azienda Socio Sanitaria Territoriale (ASST), Monza, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Carpenedo', 'Affiliation': 'Division of Haematology and Bone Marrow Transplantation Unit, Ospedale San Gerardo, Azienda Socio Sanitaria Territoriale (ASST), Monza, Italy.'}, {'ForeName': 'Maria Luigia', 'Initials': 'ML', 'LastName': 'Randi', 'Affiliation': 'Department of Medicine (DIMED), University of Padova, Padua, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bertozzi', 'Affiliation': 'Department of Medicine (DIMED), University of Padova, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Paoli', 'Affiliation': 'Center of Research and Innovation of Myeloproliferative Neoplasms (CRIMM), Azienda Ospedaliera Universitaria Careggi, and.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Department of Emergency and Organ Transplantation, Hematology Section, University of Bari, Bari, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ricco', 'Affiliation': 'Department of Emergency and Organ Transplantation, Hematology Section, University of Bari, Bari, Italy.'}, {'ForeName': 'Alessandro Maria', 'Initials': 'AM', 'LastName': 'Vannucchi', 'Affiliation': 'Center of Research and Innovation of Myeloproliferative Neoplasms (CRIMM), Azienda Ospedaliera Universitaria Careggi, and.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rodeghiero', 'Affiliation': 'Hematology Project Foundation, Vicenza, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Patrono', 'Affiliation': 'Section of Pharmacology, Catholic University School of Medicine, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'De Stefano', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy.'}]",Blood,['10.1182/blood.2019004596']
363,32185856,Horizontal ridge augmentation using native collagen membrane vs titanium mesh in atrophic maxillary ridges: Randomized clinical trial.,"BACKGROUND


Several techniques have been proposed to reconstruct deficient alveolar ridges including bone blocks, ridge splitting and guided bone regeneration (GBR). GBR has been successfully established in restoring horizontal bone deficiency. However, yet still there is a debate regarding the ideal barrier for GBR.
PURPOSE


To evaluate the quantity and the quality of the bone gained using collagen membrane with 1:1 mixture of autogenous and anoraganic bovine bone mineral compared to titanium mesh with the same mixture of bone for GBR of horizontally deficient maxillary ridges.
MATERIALS AND METHODS


Two different grafting techniques were evaluated, 10 patients receiving GBR using native collagen membrane using 1:1 autogenous and anorganic bovine bone mineral (ABBM) bone mixture, and 10 patients receiving GBR using titanium mesh with same mixture of bone.
RESULTS


Statistical analysis showed a significant increase in alveolar bone width in both techniques with a mean bone gain of 4.0 mm for Collagen group and 3.7 mm for titanium mesh group. Bone area percent was almost 28% for both groups. For Ti-mesh group, six sites soft tissue healing was uneventfully with no signs of wound dehiscence. However, four cases showed mesh exposure first 3 patients showed this exposure 3 weeks postoperatively while the fourth patient showed exposure 4 months postoperatively. The mean graft resorption in the Collagen and mesh group 6 months postoperative was considered nonsignificant.
CONCLUSIONS


GBR with both collagen membrane and titanium mesh using a 1:1 mixture of autogenous and ABBM is a viable technique for horizontal augmentation of deficient maxillary alveolar ridges. Titanium mesh is a more technique sensitive compared to collagen membrane. Soft tissue dehiscence and difficulty during second stage removal should limit its use in augmentation of horizontally deficient maxillary ridges.",2020,"RESULTS


Statistical analysis showed a significant increase in alveolar bone width in both techniques with a mean bone gain of 4.0 mm for Collagen group and 3.7 mm for titanium mesh group.","['atrophic maxillary ridges', '10 patients receiving']","['GBR using native collagen membrane using 1:1 autogenous and anorganic bovine bone mineral (ABBM) bone mixture, and 10 patients receiving GBR using titanium mesh with same mixture of bone', 'GBR', 'collagen membrane with 1:1 mixture of autogenous and anoraganic bovine bone mineral compared to titanium mesh', 'Titanium mesh', 'Horizontal ridge augmentation using native collagen membrane vs titanium mesh']","['mean bone gain', 'mean graft resorption', 'alveolar bone width']","[{'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",10.0,0.0506893,"RESULTS


Statistical analysis showed a significant increase in alveolar bone width in both techniques with a mean bone gain of 4.0 mm for Collagen group and 3.7 mm for titanium mesh group.","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Atef', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Tarek', 'Affiliation': 'Department of Oral Implantology, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Shaheen', 'Affiliation': 'Department of Oral Implantology, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Reem M', 'Initials': 'RM', 'LastName': 'Alarawi', 'Affiliation': 'Department of Oral Implantology, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Niveen', 'Initials': 'N', 'LastName': 'Askar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",Clinical implant dentistry and related research,['10.1111/cid.12892']
364,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
365,31368793,Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: a qualitative study.,"Background:  Recruitment of participants into research studies, especially individuals from minority groups, is challenging; lack of diversity may lead to biased findings.  Aim:  To explore beliefs about research participation among individuals who were approached and eligible for the GRADE study.  Methods:  In-depth qualitative telephone interviews with randomized participants (n = 25) and eligible individuals who declined to enroll (n = 26).  Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation. Few participants understood how comparative effectiveness research differed from other types of trials; however, some features of comparative effectiveness research were perceived as lower risk.  Conclusion:  We identified facilitators and addressable barriers to participation in research studies.",2019,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","['randomized participants (n\xa0=\xa025) and eligible individuals who declined to enroll (n\xa0=\xa026', 'participants into research studies, especially individuals from minority groups', 'individuals who were approached and eligible for the GRADE study']",[],"['trust and perceptions of risk, benefits and burden of participation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.150427,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Behringer-Massera', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Bone Diseases, Icahn School of Medicine, 1 Gustave L Levy Place, NY 10029, USA.'}, {'ForeName': 'Terysia', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Geny', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Duran', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of comparative effectiveness research,['10.2217/cer-2019-0010']
366,32240035,Transanal Versus Laparoscopic Total Mesorectal Excision: A Comparative Prospective Clinical Trial from Two Centers.,"Purpose:  Laparoscopic total mesorectal excision (LapTME) faced many obstacles in obese male with narrow pelvis and bulky mesorectum with increased risk of incomplete mesorectal excision and positive circumferential resection margin (CRM) and distal resection margin (DRM). Transanal total mesorectal excision (TaTME) is reported to result in a better quality total mesorectal excision (TME) specimen, lower incidence of CRM and DRM involvement, and higher rates of sphincter preservation. To date, there is still a debate about the feasibility and efficacy of transanal versus the laparoscopic approach for TME in middle and low rectal cancer.  Materials and Methods:  This is a prospective controlled clinical trial where 38 patients of middle or low rectal cancer from two tertiary centers were nonrandomly assigned to either TaTME or LapTME.  Results:  Eighteen patients were operated by TaTME versus 20 patients by LapTME. Mean body mass index was significantly higher in the TaTME group (30.74 ± 7.79) than in the LapTME group (25.99 ± 4.68) ( P  = .03). TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06). No significant differences were detected in CRM, DRM, peri- or postoperative complications, or conversion rates with more reported Clavien-Dindo grade III complications in the TaTME group ( P  = .29).  Conclusions:  TaTME facilitated rectal cancer surgery in obese patients and increased the chance of transanal specimen extraction with equivalent oncological outcomes to conventional LapTME. Further studies are recommended to build better evidence.",2020,"TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06).","['Eighteen patients were operated by TaTME versus 20 patients by LapTME', 'obese male with narrow pelvis and bulky mesorectum with increased risk of incomplete mesorectal excision and positive circumferential resection margin (CRM) and distal resection margin (DRM', 'obese patients', '38 patients of middle or low rectal cancer from two tertiary centers']","['TaTME or LapTME', 'TaTME', 'Laparoscopic total mesorectal excision (LapTME', 'Transanal Versus Laparoscopic Total Mesorectal Excision', 'Transanal total mesorectal excision (TaTME']","['Mean body mass index', 'transanal specimen extraction', 'CRM, DRM, peri- or postoperative complications, or conversion rates with more reported Clavien-Dindo grade III complications']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0447562', 'cui_str': 'Mesorectum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.0646891,"TaTME was associated with more transanal specimen extraction (55.5% versus 20%,  P  = .06).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zuhdy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Elmore', 'Affiliation': 'Department of Gastrointestinal Surgery, IRCCS San Raffaele, University Vita e Salute, Milan, Italy.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Shams', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Mohamed A F', 'Initials': 'MAF', 'LastName': 'Hegazy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Roshdy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Eldamshety', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Islam H', 'Initials': 'IH', 'LastName': 'Metwally', 'Affiliation': 'Surgical Oncology Unit, Oncology Center Mansoura University (OCMU), Mansoura, Egypt.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Rosati', 'Affiliation': 'Department of Gastrointestinal Surgery, IRCCS San Raffaele, University Vita e Salute, Milan, Italy.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0828']
367,32035020,"Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial.","BACKGROUND


Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. The FAKTION trial investigated whether the addition of capivasertib to fulvestrant improved progression-free survival in patients with aromatase inhibitor-resistant advanced breast cancer.
METHODS


In this randomised, double-blind, placebo-controlled, phase 2 trial, postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK. Enrolled participants were randomly assigned (1:1) to receive intramuscular fulvestrant 500 mg (day 1) every 28 days (plus a loading dose on day 15 of cycle 1) with either capivasertib 400 mg or matching placebo, orally twice daily on an intermittent weekly schedule of 4 days on and 3 days off (starting on cycle 1 day 15) until disease progression, unacceptable toxicity, loss to follow-up, or withdrawal of consent. Treatment allocation was done using an interactive web-response system using a minimisation method (with a 20% random element) and the following minimisation factors: measurable or non-measurable disease, primary or secondary aromatase inhibitor resistance, PIK3CA status, and PTEN status. The primary endpoint was progression-free survival with a one-sided alpha of 0·20. Analyses were done by intention to treat. Recruitment is complete, and the trial is in follow-up. This trial is registered with ClinicalTrials.gov, number NCT01992952.
FINDINGS


Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible and were randomly assigned to receive fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo (n=71). Median follow-up for progression-free survival was 4·9 months (IQR 1·6-11·6). At the time of primary analysis for progression-free survival (Jan 30, 2019), 112 progression-free survival events had occurred, 49 (71%) in 69 patients in the capivasertib group compared with 63 (89%) of 71 in the placebo group. Median progression-free survival was 10·3 months (95% CI 5·0-13·2) in the capivasertib group versus 4·8 months (3·1-7·7) in the placebo group, giving an unadjusted hazard ratio (HR) of 0·58 (95% CI 0·39-0·84) in favour of the capivasertib group (two-sided p=0·0044; one-sided log rank test p=0·0018). The most common grade 3-4 adverse events were hypertension (22 [32%] of 69 patients in the capivasertib group vs 17 [24%] of 71 in the placebo group), diarrhoea (ten [14%] vs three [4%]), rash (14 [20%] vs 0), infection (four [6%] vs two [3%]), and fatigue (one [1%] vs three [4%]). Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one). One death, due to atypical pulmonary infection, was assessed as possibly related to capivasertib treatment. One further death in the capivasertib group had an unknown cause; all remaining deaths in both groups (19 in the capivasertib group and 31 in the placebo group) were disease related.
INTERPRETATION


Progression-free survival was significantly longer in participants who received capivasertib than in those who received placebo. The combination of capivasertib and fulvestrant warrants further investigation in phase 3 trials.
FUNDING


AstraZeneca and Cancer Research UK.",2020,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","['Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible', 'postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK', 'patients with aromatase inhibitor-resistant advanced breast cancer']","['Fulvestrant plus capivasertib versus placebo', 'capivasertib to fulvestrant', 'capivasertib 400 mg or matching placebo', 'capivasertib and fulvestrant', 'fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo', 'Capivasertib (AZD5363', 'placebo', 'intramuscular fulvestrant']","['diarrhoea', '112 progression-free survival events', 'Median progression-free survival', 'acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting', 'Progression-free survival', 'rash', 'Serious adverse reactions', 'fatigue', 'infection', 'progression-free survival', 'Median follow-up for progression-free survival']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0041657', 'cui_str': 'Unconscious State'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",183.0,0.690338,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Jones', 'Affiliation': 'Department of Cancer and Genetics, Cardiff University, Cardiff, UK; Velindre Cancer Centre, Cardiff, UK. Electronic address: robert.hugh.jones@wales.nhs.uk.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Carucci', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'All Wales Laboratory Genetics Service, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Alchami', 'Affiliation': 'Department of Cellular Pathology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bale', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bezecny', 'Affiliation': 'Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Joffe', 'Affiliation': 'Calderdale & Huddersfield NHS Foundation Trust, Huddersfield, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Venkitaraman', 'Affiliation': 'The Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Waters', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sacha J', 'Initials': 'SJ', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30817-4']
368,31685489,Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.,"OBJECTIVE


To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D.
RESEARCH DESIGN AND METHODS


A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE (≥30 mg/g) were assessed annually.
RESULTS


Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA 1c , TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up.
CONCLUSIONS


Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.",2020,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","['Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ', 'Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes', 'severely obese adolescents with type 2 diabetes ', 'T2D) undergoing medical or surgical treatment for T2D', 'obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies']","['Surgical Versus Medical Therapy', 'metabolic bariatric surgery (MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['Elevated UAE', 'Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE', 'diabetic kidney disease (DKD) rates']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]",,0.0493397,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","[{'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO petter.bjornstad@childrenscolorado.org.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hughan', 'Affiliation': ""University of Pittsburgh and UPMC Children's Hospital Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nehus', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mitsnefes', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}]",Diabetes care,['10.2337/dc19-0708']
369,32253227,Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: the ELF cluster randomised controlled trial.,"OBJECTIVES


The aim of this clustered, randomised controlled trial was to assess the effectiveness of a lumbopelvic postural feedback device for changing postural behaviour in a group of healthcare workers. We hypothesised that workers exposed to auditory postural feedback would reduce the number of times forward bending posture is adopted at work.
METHODS


This was a participant and assessor blinded, randomised, sham-controlled trial with blocked cluster random allocation. We recruited healthcare workers from aged care institutions. Healthcare sites were randomly allocated to the feedback or sham group (SG). A postural monitoring and feedback device was used to monitor and record lumbopelvic forward bending posture, and provided audio feedback whenever the user sustained lumbopelvic forward bending posture that exceeded predefined thresholds. The primary outcome measure was postural behaviour (exceeding thresholds). We used a robust variant of repeated measures mixed-effect model for assessing within-group and between-group differences in postural behaviour.
RESULTS


We recruited 19 sites, and 130 healthcare workers participated. There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
CONCLUSIONS


Findings from this trial indicate that audio feedback provided by a postural monitor device did not reduce the number of times healthcare workers exceeded the postural threshold.
TRIAL REGISTRATION NUMBER


ACTRN12616000449437.",2020,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","['We recruited 19 sites, and 130 healthcare workers participated', 'healthcare workers from aged care institutions', 'Healthcare sites', 'a group of healthcare workers']","['feedback or sham group (SG', 'lumbopelvic monitor and feedback device', 'lumbopelvic postural feedback device']","['number of times postural threshold', 'postural behaviour (exceeding thresholds', 'number of times healthcare workers']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.253141,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group.
","[{'ForeName': 'Daniel Cury', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Milosavljevic', 'Affiliation': 'School of Physiotherapy, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Terry', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106293']
370,32100917,"Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study: Rationale, methodology and participant baseline characteristics.","IMPORTANCE


Atropine eyedrops are a promising treatment for slowing myopia progression in East Asian children. However, its effects on children in Australia, including those of non-Asian background, have not been well-studied.
BACKGROUND


The Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study aims to determine the efficacy and long-term effects of low-dose atropine eyedrops in myopia control. This paper describes the study rationale, methodology and participant baseline characteristics.
DESIGN


Single-centre, double-masked, randomized controlled trial.
PARTICIPANTS


Children (6-16 years) with spherical equivalent ≤-1.50 D in each eye, astigmatism ≤1.50 D and myopia progression by ≥0.50 D/year.
METHODS


Enrolled children were randomly assigned 2:1 to receive 0.01% atropine or placebo eyedrops. Participants are examined every 6 months during first 3 years of the study (2-year treatment phase followed by a 1-year washout phase), and then at a 5-year follow-up (2 years after the end of the washout phase).
MAIN OUTCOME MEASURES


Annual progression rate of myopia and axial length, tolerability to eyedrops and incidence and severity of unwanted effects.
RESULTS


Out of 311 children who were referred, 242 were suitable for study participation, and 153 were subsequently enrolled. The baseline characteristics of enrolled participants are presented.
CONCLUSIONS AND RELEVANCE


Outcomes of the WA-ATOM study will inform on the efficacy, tolerability, safety and long-term effects of low-dose atropine eyedrops in myopia control in Australian children. The impact of ocular sun exposure, iris colour and parental myopia on the efficacy of low-dose atropine will also be assessed.",2020,The Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study aims to determine the efficacy and long-term effects of low-dose atropine eyedrops in myopia control.,"['Children (6-16\u2009years) with spherical equivalent ≤\u2009-\u20091.50D in each eye, astigmatism ≤1.50D, and myopia progression by ≥0.50D/year', '311 children who were referred, 242 were suitable for study participation, and 153 were subsequently enrolled', 'Enrolled children', 'East Asian children', 'myopia control in Australian children', 'myopia control']","['atropine eyedrops', 'atropine', 'Atropine eyedrops', 'atropine or placebo eyedrops', 'Western Australia Atropine']","['efficacy, tolerability, safety', 'Annual progression rate of myopia and axial length, tolerability to eyedrops, and incidence and severity of unwanted effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",311.0,0.507785,The Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study aims to determine the efficacy and long-term effects of low-dose atropine eyedrops in myopia control.,"[{'ForeName': 'Samantha S Y', 'Initials': 'SSY', 'LastName': 'Lee', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mackey', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Lingham', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Crewe', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Richards', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Fred K', 'Initials': 'FK', 'LastName': 'Chen', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Charng', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Fletcher', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Flitcroft', 'Affiliation': 'Department of Ophthalmology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Loughman', 'Affiliation': 'Centre for Eye Research Ireland, School of Physics, Clinical and Optometric Sciences, Technological University Dublin, Dublin, Ireland.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""School of Medicine Dentistry, and Biomedical Science, Queen's University Belfast, Ireland.""}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Logan', 'Affiliation': 'School of Life & Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammond', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, St. Thomas' Hospital, London, UK.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Chia', 'Affiliation': 'Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Tan Tai', 'Initials': 'TT', 'LastName': 'Truong', 'Affiliation': 'Oxford Compounding, North Perth, Western Australia, Australia.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), University of Western Australia, Perth, Western Australia, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13736']
371,30285533,Safety and effectiveness of high-dose methotrexate (over 8 mg/week) in 2838 Japanese patients with rheumatoid arthritis: a postmarketing surveillance report.,"Objectives : To confirm the safety and effectiveness of high-dose (>8 mg/week) methotrexate (MTX) for the treatment of rheumatoid arthritis in Japan. Methods : A postmarketing surveillance program enrolled Japanese patients with rheumatoid arthritis starting on high-dose MTX followed up for 24 or 52 weeks. Analyses for safety, risk factors affecting safety, and effectiveness were conducted. Results : The safety/effectiveness analysis sets included 2838/2779 and 335/326 patients in the 24 and 52-week follow-up groups, respectively. Incidence of adverse drug reactions (ADRs) and serious ADRs was 21.42 and 1.66% in the 24-week and 35.52 and 2.69% in the 52-week groups, respectively. The Disease Activity Score in 28 Joints (DAS28) was significantly decreased as early as four weeks from the start of high-dose MTX; after 24-week (4.09-3.21) and 52-week treatment (3.91-2.80; both  p  < .001). In a majority of patients at baseline who had high-to-moderate disease activity, the remission rate (defined as DAS28-4ESR <2.6) increased three-fold from 10.6% (baseline) to 33.0% (24-week) compared to patients with low disease activity whose remission rate increased two-fold from 24.0% (baseline) to 53.6% (24 weeks). Conclusion : High-dose MTX was well tolerated in Japanese patients, resulted in improved disease control, and can be considered a step forward in achieving treat-to-target goals.",2020,"Incidence of adverse drug reactions (ADRs) and serious ADRs was 21.42% and 1.66% in the 24-week and 35.52% and 2.69% in the 52-week groups, respectively.","['A postmarketing surveillance program enrolled Japanese patients with rheumatoid arthritis starting on high-dose MTX followed up for 24 or 52 weeks', 'rheumatoid arthritis in Japan', 'Japanese patients', '2838 Japanese patients with rheumatoid arthritis']","['MTX', 'high-dose methotrexate', 'methotrexate (MTX']","['remission rate', 'Disease Activity Score', 'Safety and effectiveness', 'Incidence of adverse drug reactions (ADRs) and serious ADRs', 'safety, risk factors affecting safety, and effectiveness']","[{'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",,0.0236614,"Incidence of adverse drug reactions (ADRs) and serious ADRs was 21.42% and 1.66% in the 24-week and 35.52% and 2.69% in the 52-week groups, respectively.","[{'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Naonobu', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Fukuma', 'Affiliation': 'Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Development Japan, Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kokubo', 'Affiliation': 'Development Japan, Pfizer Japan Inc., Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2018.1532483']
372,32247531,An Experimental Series Investigating the Effects of Hyperinsulinemic Euglycemia on Myocardial Blood Flow Reserve in Healthy Individuals and on Myocardial Perfusion Defect Size following ST-Segment Elevation Myocardial Infarction.,"BACKGROUND


Incomplete restoration of myocardial blood flow (MBF) is reported in up to 30% of ST-segment elevation myocardial infarction (STEMI) despite prompt mechanical revascularization. Experimental hyperinsulinemic euglycemia (HE) increases MBF reserve (MBFR). If fully exploited, this effect may also improve MBF to ischemic myocardium. Using insulin-dextrose infusions to induce HE, we conducted four experiments to determine (1) how insulin infusion duration, dose, and presence of insulin resistance affect MBFR response; and (2) the effect of an insulin-dextrose infusion given immediately following revascularization of STEMI on myocardial perfusion.
METHODS


The MBFR was determined using myocardial contrast echocardiography. Experiment 1 (insulin duration): 12 participants received an insulin-dextrose or saline infusion for 120 minutes. MBFR was measured at four time intervals during infusion. Experiment 2 (insulin dose): 22 participants received one of three insulin doses (0.5, 1.5, 3.0 mU/kg/minute) for 60 minutes. Baseline and 60-minute MBFRs were determined. Experiment 3 (insulin resistance): five metabolic syndrome and six type 2 diabetes (T2DM) participants received 1.5 mU/kg/minute of insulin-dextrose for 60 minutes. Baseline and 60-minute MBFRs were determined. Experiment 4 (STEMI): following revascularization for STEMI, 20 patients were randomized to receive either 1.5 mU/kg/minute insulin-dextrose infusion for 120 minutes or standard care. Myocardial contrast echocardiography was performed at four time intervals to quantify percentage contrast defect length.
RESULTS


Experiment 1: MBFR increased with time through to 120 minutes in the insulin-dextrose group and did not change in controls. Experiment 2: compared with baseline, MBFR increased in the 1.5 (2.42 ± 0.39 to 3.25 ± 0.77, P = .002), did not change in the 0.5, and decreased in the 3.0 (2.64 ± 0.25 to 2.16 ± 0.33, P = .02) mU/kg/minute groups. Experiment 3: compared with baseline, MBFR increase was only borderline significant in metabolic syndrome and T2DM participants (1.98 ± 0.33 to 2.59 ± 0.45, P = .04, and 1.67 ± 0.35 to 2.14 ± 0.21, P = .05). Experiment 4: baseline percentage contrast defect length was similar in both groups but with insulin decreased with time and was significantly lower than in controls at 60 minutes (2.8 ± 5.7 vs 13.7 ± 10.6, P = .02).
CONCLUSIONS


Presence of T2DM, insulin infusion duration, and dose are important determinants of the MBFR response to HE. When given immediately following revascularization for STEMI, insulin-dextrose reduces perfusion defect size at one hour. Hyperinsulinemic euglycemia may improve MBF following ischemia, but further studies are needed to clarify this.",2020,"Experiment 4: baseline percentage contrast defect length was similar in both groups but with insulin decreased with time and was significantly lower than in controls at 60 minutes (2.8 ± 5.7 vs 13.7 ± 10.6, P = .02).
","['Experiment 3 (insulin resistance): five metabolic syndrome and six type 2 diabetes (T2DM) participants received', 'Healthy Individuals and on Myocardial Perfusion Defect Size following ST-Segment Elevation Myocardial Infarction']","['Hyperinsulinemic euglycemia', '1.5 mU/kg/minute of insulin-dextrose', 'insulin-dextrose infusion', 'Hyperinsulinemic Euglycemia', '1.5 mU/kg/minute insulin-dextrose infusion for 120\xa0minutes or standard care', 'STEMI, insulin-dextrose', 'insulin-dextrose or saline infusion']","['baseline percentage contrast defect length', 'Experimental hyperinsulinemic euglycemia (HE) increases MBF reserve (MBFR', 'MBFR', 'Myocardial Blood Flow', 'myocardial blood flow (MBF', 'metabolic syndrome']","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0428858', 'cui_str': 'Myocardial perfusion defect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1960958', 'cui_str': 'Milliunit/kilogram'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",20.0,0.0765545,"Experiment 4: baseline percentage contrast defect length was similar in both groups but with insulin decreased with time and was significantly lower than in controls at 60 minutes (2.8 ± 5.7 vs 13.7 ± 10.6, P = .02).
","[{'ForeName': 'Michael C Y', 'Initials': 'MCY', 'LastName': 'Nam', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Annelise L', 'Initials': 'AL', 'LastName': 'Meneses', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, Queensland, Australia.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Byrne', 'Affiliation': 'Nutrition and Metabolism, Institute for Developmental Sciences, University of Southampton, Southampton, United Kingdom; Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Tuppence', 'Initials': 'T', 'LastName': 'Richman', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Jing Xian', 'Initials': 'JX', 'LastName': 'Quah', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, Queensland, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hickman', 'Affiliation': 'Diamantina Institute for Cancer, Immunology and Metabolic Medicine, Princess Alexandra Hospital, University of Queensland, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Anstey', 'Affiliation': 'Department of Intensive Care, Sunshine Coast Hospital and Health Services and University of Queensland, Birtinya, Queensland, Australia.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Askew', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia; VasoActive Research Group, School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, Queensland, Australia.'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Biomedical Research Unit, National Heart and Lung Institute, Imperial College London, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stanton', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia; VasoActive Research Group, School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Russell', 'Affiliation': 'Department of Diabetes and Endocrinology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; PA Southside Clinical Unit, Faculty of Medicine, University of Queensland, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Greaves', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia; VasoActive Research Group, School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: kim.greaves@health.qld.gov.au.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.01.010']
373,32250250,Fractional flow reserve-guided multivessel angioplasty in myocardial infarction: three-year follow-up with cost benefit analysis of the Compare-Acute trial.,"AIMS


The Compare-Acute trial showed superiority of fractional flow reserve (FFR)-guided acute complete revascularisation compared to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at one year. The aim of this study was to investigate the outcome at three years, together with cost analysis of this strategy.
METHODS AND RESULTS


After primary percutaneous coronary intervention (PCI), 885 patients with STEMI and MVD were randomised (1:2 ratio) to FFR-guided complete revascularisation (295 patients) or infarct-related artery (IRA)-only treatment (590 patients). After 36 months, the primary endpoint (composite of death, myocardial infarction, revascularisation, stroke) occurred significantly less frequently in the FFR-guided complete revascularisation group: 46/295 patients (15.6%) versus 178/590 patients (30.2%) (HR 0.46, 95% CI: 0.33-0.64; p<0.001). This benefit was driven mainly by the reduction of revascularisations in the follow-up (12.5% vs 25.2%; HR 0.45, 95% CI: 0.31-0.64; p<0.001). Cost analysis shows benefit of the FFR-guided complete revascularisation strategy, which can reduce the cost per patient by up to 21% at one year (8,150€ vs 10,319€) and by 22% at three years (8,653€ vs 11,100€).
CONCLUSIONS


In patients with STEMI and MVD, FFR-guided complete revascularisation is more beneficial in terms of outcome and healthcare costs compared to IRA-only revascularisation at 36 months.",2020,"In patients with STEMI and MVD, FFR-guided complete revascularization is more beneficial in terms of outcome and health-care costs compared to IRA-only revascularization at 36 months.","['Myocardial Infarction', 'patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at 1 year', '885 patients with STEMI and MVD']","['FFR-guided complete revascularization (295 patients) or infarct-related artery (IRA)-only treatment', 'Fractional Flow Reserve-Guided Multivessel Angioplasty', 'percutaneous coronary intervention (PCI', 'fractional flow reserve (FFR)-guided acute complete revascularization']","['point (composite of death, myocardial infarction, revascularization, stroke']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",885.0,0.074449,"In patients with STEMI and MVD, FFR-guided complete revascularization is more beneficial in terms of outcome and health-care costs compared to IRA-only revascularization at 36 months.","[{'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maastad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Pietro L', 'Initials': 'PL', 'LastName': 'Laforgia', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Boxma-de Klerk', 'Affiliation': ''}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Lunde', 'Affiliation': ''}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': ''}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Piroth', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Horak', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': ''}, {'ForeName': 'Geert W', 'Initials': 'GW', 'LastName': 'Frederix', 'Affiliation': ''}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00012']
374,32175655,Pharmacokinetic and dose-finding studies on efpeglenatide in patients with type 2 diabetes.,"AIM


To assess the efficacy, safety and pharmacokinetic/pharmacodynamic properties of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist, in patients with type 2 diabetes (T2D).
RESEARCH DESIGN AND METHODS


Two randomized, double-blind, placebo-controlled phase 2 trials were conducted. The single-dose study (n = 48) was a first-in-patient, sequential dose-escalation study. Patients received a single subcutaneous injection of efpeglenatide (2-100 μg/kg) or placebo. The repeated-dose study (n = 71) was a multiple-ascending-dose trial. Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
RESULTS


Both studies demonstrated dose-proportional increases in efpeglenatide serum concentrations. The median time to attain maximum serum concentration (t max  ) for efpeglenatide ranged from 72 to 144 hours in the single-dose study and from 48 to 120 hours in the repeated-dose study (following final dose). Geometric mean t 1/2  ranged from 135 to 180 hours across studies. Peak-to-trough ratios in the repeated-dose study ranged from 1.3 to 1.4 with once-weekly dosing and from 5.9 to 12.9 with once-monthly dosing. Following a single dose of efpeglenatide 14-100 μg/kg, fasting plasma glucose and postprandial plasma glucose levels were decreased at week 1 and remained below baseline levels for ≥3 weeks post-dosing. Repeated doses of efpeglenatide led to significant reductions in glycated haemoglobin vs placebo. In both studies, efpeglenatide was generally well tolerated. Gastrointestinal disorders were the most frequently reported treatment-emergent adverse events in efpeglenatide-treated patients.
CONCLUSIONS


The delayed t max,  long half-life, and low peak-to-trough ratios observed demonstrate potential for improved efficacy and dosing flexibility, with good tolerability of efpeglenatide in patients with T2D.",2020,Repeated doses of efpeglenatide led to significant reductions in HbA 1c  versus placebo.,"['patients with type 2 diabetes (T2D', 'patients with type 2 diabetes', 'patients with T2D']","['efpeglenatide or placebo (without titration', 'placebo', 'single subcutaneous injection of efpeglenatide']","['Gastrointestinal disorders', 'tolerated', 'Peak-to-trough ratios', 'delayed t max,  long half-life, and low peak-to-trough ratios', 'efpeglenatide serum concentrations', 'efficacy, safety, and pharmacokinetic/pharmacodynamic properties of efpeglenatide', 'FPG and PPG levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.226372,Repeated doses of efpeglenatide led to significant reductions in HbA 1c  versus placebo.,"[{'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jahoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Se Chang', 'Initials': 'SC', 'LastName': 'Kwon', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'ProSciento, Chula Vista, California, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Chula Vista, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi Canada, Laval, Quebec, Canada.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Sorli', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14032']
375,32238534,Mindfulness-Based Stress Reduction for Parents Implementing Early Intervention for Autism: An RCT.,"BACKGROUND AND OBJECTIVES


Systems of care emphasize parent-delivered intervention for children with autism spectrum disorder (ASD). Meanwhile, multiple studies document psychological distress within these parents. This pilot longitudinal randomized controlled trial compared the parent-implemented Early Start Denver Model (P-ESDM) to P-ESDM plus mindfulness-based stress reduction (MBSR) for parents. We evaluated changes in parent functioning during active treatment and at follow-up.
METHODS


Participants included children (<36 months old) with autism spectrum disorder and caregivers. Participants were randomly assigned to P-ESDM only ( n  = 31) or P-ESDM plus MBSR ( n  = 30). Data were collected at baseline, midtreatment, the end of treatment, and 1, 3, and 6 months posttreatment. Multilevel models with discontinuous slopes were used to test for group differences in outcome changes over time.
RESULTS


Both groups improved during active treatment in all subdomains of parent stress (β = -1.42, -1.25, -0.92;  P  < 0.001), depressive symptoms, and anxiety symptoms (β = -0.62 and -0.78, respectively;  P  < 0.05). Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01). Groups differed in change in mindfulness during treatment (β = 3.15;  P  < .05), with P-ESDM plus MBSR increasing and P-ESDM declining. Treatment group did not significantly predict change in depressive symptoms, anxiety symptoms, or life satisfaction. Differences emerged on the basis of parent sex, child age, and child behavior problems.
CONCLUSIONS


Results suggest that manualized, low-intensity stress-reduction strategies may have long-term impacts on parent stress. Limitations and future directions are described.",2020,"Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01).","['Participants included children (<36 months old) with autism spectrum disorder and caregivers', 'parents', 'Parents Implementing Early Intervention for Autism', 'children with autism spectrum disorder (ASD']","['parent-implemented Early Start Denver Model (P-ESDM) to P-ESDM plus mindfulness-based stress reduction (MBSR', 'MBSR', 'Mindfulness-Based Stress Reduction', 'P-ESDM', 'P-ESDM plus MBSR']","['parental distress and parent-child dysfunctional interactions', 'depressive symptoms, anxiety symptoms, or life satisfaction', 'depressive symptoms, and anxiety symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.070461,"Parents who received MBSR had greater improvements than those receiving P-ESDM only in parental distress and parent-child dysfunctional interactions (β = -1.91 and -1.38, respectively;  P  < 0.01).","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Weitlauf', 'Affiliation': 'Departments of Pediatrics and amy.s.weitlauf@vumc.org.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Broderick', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'J Alacia', 'Initials': 'JA', 'LastName': 'Stainbrook', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Julie Lounds', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Herrington', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Nicholson', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Santulli', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Dykens', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'A Pablo', 'Initials': 'AP', 'LastName': 'Juárez', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Zachary E', 'Initials': 'ZE', 'LastName': 'Warren', 'Affiliation': 'Departments of Pediatrics and.'}]",Pediatrics,['10.1542/peds.2019-1895K']
376,31261168,Complex effects of continuous vasopressor infusion on fluid responsiveness during liver resection: A randomised controlled trial.,"BACKGROUND


Fluid responsiveness is an important factor to consider for fluid volume loading during major surgery. The effect of continuous vasopressor infusion on fluid responsiveness during prolonged major surgery is a concern.
OBJECTIVE


We hypothesised that continuous vasopressor infusion during major surgery might not exert significant effects on changes in stroke volume variation (SVV) following fluid bolus infusion, and thereby on fluid responsiveness.
DESIGN


Randomised controlled trial.
SETTING


University hospital from April 2014 to August 2016.
PATIENTS


Patients undergoing liver resection who were randomised to receive continuous intravenous infusion of phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group). Exclusion criteria were cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction.
INTERVENTION


Patients received 4 ml kg fluid boluses of 6% hydroxyethyl starch solution when SVV was at least 12%. Vasopressors were administered continuously to maintain the systemic vascular resistance index at more than 1900 dyn s cm m.
MAIN OUTCOME MEASURES


Cardiac index and SVV were measured using the FloTrac/Vigileo system (Version 4.00). The number of fluid boluses with fluid responsiveness (i.e. >15% increase in cardiac index) was compared between groups using multilevel logistic regression analysis.
RESULTS


Numbers of fluid responsive boluses in the C, P and N groups were 12 (14%), 22 (34%) and 19 (27%), respectively. Odds ratios on fluid responsiveness for phenylephrine and norepinephrine compared with the control were 3.65 (97.5% confidence interval, 1.15 to 11.6; P = 0.012) and 2.56 (97.5% confidence interval, 0.82 to 8.00; P = 0.064), respectively. Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
CONCLUSION


Continuous administration of phenylephrine increased fluid responsiveness during liver resection, suggesting complex effects of continuous vasopressor infusion involving changes in cardiac preload and afterload.
TRIAL REGISTRATION


UMIN000011024.",2019,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","['University hospital from April 2014 to August 2016', 'Patients undergoing liver resection', 'liver resection']","['continuous vasopressor infusion', 'phenylephrine', 'phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group', '4\u200aml\u200akg fluid boluses of 6% hydroxyethyl starch solution', 'phenylephrine and norepinephrine']","['stroke volume variation (SVV', 'number of fluid boluses with fluid responsiveness', 'cardiac index', 'SVV', 'systemic vascular resistance index', 'Odds ratios on fluid responsiveness', 'Cardiac index and SVV', 'cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction', 'fluid responsiveness']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",,0.56142,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","[{'ForeName': 'Shiroh', 'Initials': 'S', 'LastName': 'Nakamoto', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan (SN, TT, TO, MH).'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Tatara', 'Affiliation': ''}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': ''}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001046']
377,32014119,"Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis (New EPOC): long-term results of a multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


The interim analysis of the multicentre New EPOC trial in patients with resectable colorectal liver metastasis showed a significant reduction in progression-free survival in patients allocated to cetuximab plus chemotherapy compared with those given chemotherapy alone. The focus of the present analysis was to assess the effect on overall survival.
METHODS


New EPOC was a multicentre, open-label, randomised, controlled, phase 3 trial. Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2 were randomly assigned (1:1) to receive chemotherapy with or without cetuximab before and after liver resection. Randomisation was done centrally with minimisation factors of surgical centre, poor prognosis cancer, and previous adjuvant treatment with oxaliplatin. Chemotherapy consisted of oxaliplatin 85 mg/m 2  administered intravenously over 2 h, l-folinic acid (175 mg flat dose administered intravenously over 2 h) or d,l-folinic acid (350 mg flat dose administered intravenously over 2 h), and fluorouracil bolus 400 mg/m 2  administered intravenously over 5 min, followed by a 46 h infusion of fluorouracil 2400 mg/m 2  repeated every 2 weeks (regimen one), or oxaliplatin 130 mg/m 2  administered intravenously over 2 h and oral capecitabine 1000 mg/m 2  twice daily on days 1-14 repeated every 3 weeks (regimen two). Patients who had received adjuvant oxaliplatin could receive irinotecan 180 mg/m 2  intravenously over 30 min with fluorouracil instead of oxaliplatin (regimen three). Cetuximab was given intravenously, 500 mg/m 2  every 2 weeks with regimen one and three or a loading dose of 400 mg/m 2  followed by a weekly infusion of 250 mg/m 2  with regimen two. The primary endpoint of progression-free survival was published previously. Secondary endpoints were overall survival, preoperative response, pathological resection status, and safety. Trial recruitment was halted prematurely on the advice of the Trial Steering Committee on Nov 1, 2012. All analyses (except safety) were done on the intention-to-treat population. Safety analyses included all randomly assigned patients. This trial is registered with ISRCTN, number 22944367.
FINDINGS


Between Feb 26, 2007, and Oct 12, 2012, 257 eligible patients were randomly assigned to chemotherapy with cetuximab (n=129) or without cetuximab (n=128). This analysis was carried out 5 years after the last patient was recruited, as defined in the protocol, at a median follow-up of 66·7 months (IQR 58·0-77·5). Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304). Median overall survival was 81·0 months (59·6 to not reached) in the chemotherapy alone group and 55·4 months (43·5-71·5) in the chemotherapy plus cetuximab group (HR 1·45, 1·02-2·05; p=0·036). There was no significant difference in the secondary outcomes of preoperative response or pathological resection status between groups. Five deaths might have been treatment-related (one in the chemotherapy alone group and four in the chemotherapy plus cetuximab group). The most common grade 3-4 adverse events reported were: neutrophil count decreased (26 [19%] of 134 in the chemotherapy alone group vs 21 [15%] of 137 in the chemotherapy plus cetuximab group), diarrhoea (13 [10%] vs 14 [10%]), skin rash (one [1%] vs 22 [16%]), thromboembolic events (ten [7%] vs 11 [8%]), lethargy (ten [7%] vs nine [7%]), oral mucositis (three [2%] vs 14 [10%]), vomiting (seven [5%] vs seven [5%]), peripheral neuropathy (eight [6%] vs five [4%]), and pain (six [4%] vs six [4%]).
INTERPRETATION


Although the addition of cetuximab to chemotherapy improves the overall survival in some studies in patients with advanced, inoperable metastatic disease, its use in the perioperative setting in patients with operable disease confers a significant disadvantage in terms of overall survival. Cetuximab should not be used in this setting.
FUNDING


Cancer Research UK.",2020,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","['Between Feb 26, 2007, and Oct 12, 2012', 'Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2', 'patients with resectable colorectal liver metastasis (New EPOC', 'patients with advanced, inoperable metastatic disease', 'patients with resectable colorectal liver metastasis', '257 eligible patients']","['adjuvant oxaliplatin', 'Cetuximab', 'l-folinic acid', 'irinotecan 180 mg/m 2  intravenously over 30 min with fluorouracil instead of oxaliplatin', 'cetuximab to chemotherapy', 'oxaliplatin 130 mg/m 2  administered intravenously over 2 h and oral capecitabine', 'cetuximab plus chemotherapy', 'Systemic chemotherapy with or without cetuximab', 'fluorouracil', 'oxaliplatin 85 mg/m 2  administered intravenously over 2 h, l-folinic acid', 'chemotherapy with or without cetuximab', 'chemotherapy with cetuximab (n=129) or without cetuximab', 'oxaliplatin']","['diarrhoea', 'thromboembolic events', 'Median progression-free survival', 'peripheral neuropathy', 'lethargy', 'Median overall survival', 'vomiting', 'pain', 'neutrophil count', 'preoperative response or pathological resection status', 'progression-free survival', 'skin rash', 'overall survival', 'overall survival, preoperative response, pathological resection status, and safety', 'oral mucositis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009221', 'cui_str': 'Codon'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",257.0,0.335991,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK. Electronic address: j.bridgewater@ucl.ac.uk.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'Pugh', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Eminton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Mellor', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Whitehead', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Gareth O', 'Initials': 'GO', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences/The Christie NHS Foundation Trust, University of Manchester, Manchester, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Ajith K', 'Initials': 'AK', 'LastName': 'Siriwardena', 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hornbuckle', 'Affiliation': 'Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Myrddin', 'Initials': 'M', 'LastName': 'Rees', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Iveson', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Dorset Cancer Centre/Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'Clinical Surgery, University of Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'Department of Surgery, University of Southampton, Southampton, UK. Electronic address: j.n.primrose@soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30798-3']
378,32248405,Concentration of NK cells after β-glucan and vitamin D supplementation in patients with diabetic retinopathy.,"In our study, we focused on possible effects of supplementation with glucan and vitamin D on total numbers of NK cells in patients with diabetic retinopathy. We evaluated possible relations among nutritional state (BMI), leptin levels, and total numbers of NK cells in patients supplemented with (1) glucan and vitamin D, (2) vitamin D and placebo, and (3) vitamin D alone. Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers. In addition, we found statistically significant correlation between NK cell numbers and leptin levels. Based on these results, we propose that the molecule responsible for these changes is glucan, as vitamin D alone or together with placebo caused no effects.",2020,Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers.,"['patients supplemented with (1', 'patients with diabetic retinopathy']","['placebo', 'glucan and vitamin D, (2) vitamin D and placebo, and (3) vitamin D alone', 'vitamin D', 'β-glucan and vitamin D supplementation', 'supplementation with glucan and vitamin D']","['nutritional state (BMI), leptin levels, and total numbers of NK cells', 'NK cell numbers and leptin levels', 'NK cell numbers', 'Concentration of NK cells', 'total numbers of NK cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.113824,Our results show that 3 months of supplementation with both glucan and vitamin D resulted in significant improvements of NK cell numbers.,"[{'ForeName': 'Richter', 'Initials': 'R', 'LastName': 'Josef', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Pohorska', 'Initials': 'P', 'LastName': 'Jitka', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Závorková', 'Initials': 'Z', 'LastName': 'Martina', 'Affiliation': 'Oční klinika UJEP Masarykova nemocnice, Krajská zdravotní, a.s., Usti nad Labem, Czech Republic.'}, {'ForeName': 'Král', 'Initials': 'K', 'LastName': 'Vlastimil', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Stiborova', 'Initials': 'S', 'LastName': 'Ivana', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Dobiasova Rajnohova', 'Initials': 'DR', 'LastName': 'Lucie', 'Affiliation': 'Zdravotní ústav se sídlem v Ústí nad Labem, Usti nad Labem, Czech Republic.'}, {'ForeName': 'Vetvicka', 'Initials': 'V', 'LastName': 'Vaclav', 'Affiliation': 'Department of Pathology, University of Louisville, 511 S. Floyd St., Louisville, KY, 40202, USA. Vaclav.vetvicka@louisville.edu.'}]",Folia microbiologica,['10.1007/s12223-020-00789-2']
379,30891960,The Use of Eye Tracking as a Biomarker of Treatment Outcome in a Pilot Randomized Clinical Trial for Young Children with Autism.,"There is a pressing need for objective, quantifiable outcome measures in intervention trials for children with autism spectrum disorder (ASD). The current study investigated the use of eye tracking as a biomarker of treatment response in the context of a pilot randomized clinical trial of treatment for young children with ASD. Participants included 28 children with ASD, aged 18-48 months, who were randomized to one of two conditions: Pivotal Response Intervention for Social Motivation (PRISM) or community treatment as usual (TAU). Eye-tracking and behavioral assessment of developmental functioning were administered at Time 1 (prior to randomization) and at Time 2 (after 6 months of intervention). Two well-established eye-tracking paradigms were used to measure social attention: social preference and face scanning. As a context for understanding relationships between social attention and developmental ability, we first examined how scanning patterns at Time 1 were associated with concurrent developmental functioning and compared to those of 23 age-matched typically developing (TD) children. Changes in scanning patterns from Time 1 to Time 2 were then compared between PRISM and TAU groups and associated with behavioral change over time. Results showed that the social preference paradigm differentiated children with ASD from TD children. In addition, attention during face scanning was associated with language and adaptive communication skills at Time 1 and change in language skills from Time 1 to Time 2. These findings highlight the importance of examining targeted biomarkers that measure unique aspects of child functioning and that are well-matched to proposed mechanisms of change. Autism Research 2019, 12: 779-793. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Biomarkers have the potential to provide important information about how and why early interventions effect positive change for young children with ASD. The current study suggests that eye-tracking measures of social attention can be used to track change in specific areas of development, such as language, and points to the need for targeted eye-tracking paradigms designed to measure specific behavioral changes. Such biomarkers could inform the development of optimal, individualized, and adaptive interventions for young children with ASD.",2019,"In addition, attention during face scanning was associated with language and adaptive communication skills at Time 1 and change in language skills from Time 1 to Time 2.","['children with ASD from TD children', 'Autism Research 2019, 12: 779-793', 'Participants included 28 children with ASD, aged 18-48\u2009months', 'children with autism spectrum disorder (ASD', 'Young Children with Autism', 'young children with ASD']",['Pivotal Response Intervention for Social Motivation (PRISM) or community treatment as usual (TAU'],['social attention: social preference and face scanning'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0035168'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",28.0,0.0367847,"In addition, attention during face scanning was associated with language and adaptive communication skills at Time 1 and change in language skills from Time 1 to Time 2.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bradshaw', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Shic', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Anahita N', 'Initials': 'AN', 'LastName': 'Holden', 'Affiliation': 'Department of Counseling, Clinical, and School Psychology, University of California Santa Barbara, Santa Barbara, California.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Horowitz', 'Affiliation': 'Department of Psychological and Brain Sciences, University of California Santa Barbara, Santa Barbara, California.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Barrett', 'Affiliation': 'Department of Counseling, Clinical, and School Psychology, University of California Santa Barbara, Santa Barbara, California.'}, {'ForeName': 'Tamsin C', 'Initials': 'TC', 'LastName': 'German', 'Affiliation': 'Department of Psychological and Brain Sciences, University of California Santa Barbara, Santa Barbara, California.'}, {'ForeName': 'Ty W', 'Initials': 'TW', 'LastName': 'Vernon', 'Affiliation': 'Department of Counseling, Clinical, and School Psychology, University of California Santa Barbara, Santa Barbara, California.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2093']
380,32222015,"Effects of caffeine consumption on intraocular pressure during low-intensity endurance exercise: A placebo-controlled, double-blind, balanced crossover study.","IMPORTANCE


Intraocular pressure (IOP) is sensitive to caffeine intake and physical exercise. However, the combined effect of caffeine intake and physical exercise on IOP levels remains unknown.
BACKGROUND


We aimed to assess the effects of caffeine consumption before exercise on the IOP behaviour during low-intensity endurance exercise.
DESIGN


A placebo-controlled, double-blind, balanced crossover study at the University of Granada.
PARTICIPANTS


Eighteen physically active young adults (age = 23.3 ± 2.4 years) participated in this study.
METHODS


Participants performed 30 minutes of cycling at 10% of maximal power production after 30 minutes of ingesting a capsule of caffeine (~4 mg/kg) and placebo in two different days and following a double-blind procedure.
MAIN OUTCOME MEASURE


IOP was measured at baseline (before caffeine/placebo ingestion), after 5 minutes of warm-up, during cycling (6, 12, 18, 24 and 30 minutes) and recovery (5 and 10 minutes) by rebound tonometry.
RESULTS


There was a significant effect of caffeine consumption (P < .001, η 2  = 0.50), showing that the ingestion of caffeine before exercise counteracted the IOP-lowering response to low-intensity endurance exercise. Greater IOP values at 12, 18, 24 and 30 minutes (corrected P-values<.05, ds = 0.90-1.08) of cycling were observed for the caffeine in comparison to the placebo condition.
CONCLUSIONS AND RELEVANCE


The ingestion of caffeine (~4 mg/kg) 30 minutes before performing low-intensity endurance exercise counteracts the IOP-lowering effect of low-intensity exercise. These results highlight that the ingestion of a considerable amount of caffeine before exercise should be discouraged for individuals who would benefit from the IOP reduction associated with low-intensity exercise (ie, glaucoma patients or those at risk).",2020,"There was a significant effect of caffeine consumption (P < 0.001, η 2   = 0.50), showing that the ingestion of caffeine before exercise counteracted the IOP-lowering response to low-intensity endurance exercise.","['18 physically active young adults (age\xa0=\xa023.3\u2009±\u20092.4\u2009years', 'low-intensity endurance exercise', 'Participants performed 30\u2009minutes of cycling at 10% of']","['placebo', 'caffeine consumption', 'caffeine intake and physical exercise', 'caffeine', 'caffeine consumption before exercise', 'maximal power production after 30\u2009minutes of ingesting a capsule of caffeine']","['Greater IOP values', 'caffeine consumption', 'IOP', 'intraocular pressure', 'IOP behavior', 'IOP levels']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0585043', 'cui_str': 'Before exercise (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",18.0,0.32821,"There was a significant effect of caffeine consumption (P < 0.001, η 2   = 0.50), showing that the ingestion of caffeine before exercise counteracted the IOP-lowering response to low-intensity endurance exercise.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Bardón', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada, Granada, Spain.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13755']
381,31306184,Comparison of low and high positive end-expiratory pressure during low tidal volume ventilation in robotic gynaecological surgical patients using electrical impedance tomography: A randomised controlled trial.,"BACKGROUND


The appropriate level of positive end-expiratory pressure (PEEP) during intra-operative mechanical ventilation remains unclear.
OBJECTIVE


The aim of this study was to investigate the effects of different levels of PEEP with low tidal volume (low-VT) ventilation in a steep Trendelenburg position (30°) and pneumoperitoneum on oxygenation, respiratory mechanics and ventilation distribution using electrical impedance tomography.
DESIGN


A randomised controlled trial.
SETTING


Single university secondary care centre, conducted from January 2017 to December 2017.
PATIENTS


Forty female patients, aged 20 to 60 years, and of American Society of Anesthesiologists' (ASA) physical status 1 or 2, undergoing elective robotic gynaecological surgery were included.
INTERVENTION


Forty patients were allocated randomly to a PEEP4 (PEEP 4 cmH2O) group or a PEEP8 (PEEP 8 cmH2O) group.
MAIN OUTCOME MEASURES


The primary outcomes were respiratory mechanics. The secondary outcomes included changes in ventilation distribution across the ventral and dorsal regions of interest and postoperative pulmonary complications (PPCs) using a modified clinical pulmonary infection score.
RESULTS


There was no difference in PaO2 at any time point. The peak inspiratory pressure (PIP) and mean airway pressure (MPAW) of the PEEP4 group were lower than those of the PEEP8 group (P < 0.001). The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times. There was no difference in the fractional distribution of end-expiratory ventilation according to region of interest between the two groups.
CONCLUSION


Both 4 and 8 cmH2O of PEEP with low-VT ventilation can be used for robotic gynaecological surgery that requires a steep Trendelenburg position and pneumoperitoneum. However, 8 cmH2O of PEEP had no benefit over 4 cmH2O of PEEP with respect to oxygenation and improvement of dorsal regional ventilation.
TRIAL REGISTRATION


The trial was registered at the Clinical Trial Registry of Korea (KCT0002255). https://cris.nih.go.kr.",2019,The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times.,"[""Forty female patients, aged 20 to 60 years, and of American Society of Anesthesiologists' (ASA) physical status 1 or 2, undergoing elective robotic gynaecological surgery were included"", 'Single university secondary care centre, conducted from January 2017 to December 2017', 'robotic gynaecological surgical patients using electrical impedance tomography', 'Forty patients']","['PEEP with low tidal volume (low-VT) ventilation', 'low and high positive end-expiratory pressure during low tidal volume ventilation', 'PEEP with low-VT ventilation', 'PEEP4 (PEEP 4\u200acmH2O) group or a PEEP8 (PEEP 8\u200acmH2O) group', 'PEEP8']","['respiratory mechanics', 'peak inspiratory pressure (PIP) and mean airway pressure (MPAW', 'fractional distribution of end-expiratory ventilation', 'oxygenation factor', 'PaO2', 'dorsal regional ventilation', 'changes in ventilation distribution across the ventral and dorsal regions of interest and postoperative pulmonary complications (PPCs) using a modified clinical pulmonary infection score']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C1456859', 'cui_str': 'Thoracic region (surface region of back)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.164233,The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times.,"[{'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Chun', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, College of Medicine, Ewha Womans University (HJB), Department of Anaesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine (EHC), and Department of Obstetrics and Gynecology, College of Medicine, Ewha Womans University, Seoul, Republic of Korea (HM, KJ).'}, {'ForeName': 'Hee Jung', 'Initials': 'HJ', 'LastName': 'Baik', 'Affiliation': ''}, {'ForeName': 'Hye-Sung', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Jeong', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001047']
382,31934793,Thalamic Gamma Aminobutyric Acid Level Changes in Major Depressive Disorder After a 12-Week Iyengar Yoga and Coherent Breathing Intervention.,"Objective:  To determine if a 12-week yoga intervention (YI) was associated with increased gamma aminobutyric acid (GABA) levels and decreased depressive symptoms in participants with major depressive disorder (MDD).  Methods : Subjects were randomized to a high-dose group (HDG) of three YIs a week and a low-dose group (LDG) of two YIs a week. Thalamic GABA levels were obtained using magnetic resonance spectroscopy at Scan-1 before randomization. After the assigned 12-week intervention, Scan-2 was obtained, immediately followed by a YI and Scan-3. Beck Depression Inventory II (BDI-II) scores were obtained before Scan-1 and Scan-3.  Settings/Location:  Screenings and interventions occurred at the Boston University Medical Center. Imaging occurred at McLean Hospital.  Subjects:  Subjects met criteria for MDD.  Intervention:  Ninety minutes of Iyengar yoga and coherent breathing at five breaths per minute plus homework.  Outcome measures:  GABA levels and the BDI-II.  Results:  BDI-II scores improved significantly in both groups. GABA levels from Scan-1 to Scan-3 and from Scan-2 to Scan-3 were significantly increased in the LDG ( n  = 15) and showed a trend in the total cohort.  Post hoc , participants were divided into two groups based on having an increase in GABA levels at Scan-2. Increases in Scan-2 GABA levels were observed in participants whose mean time between their last YI and Scan-2 was 3.93 ± 2.92 standard deviation (SD) days, but not in those whose mean time between their last YI and Scan-2 was 7.83 ± 6.88 SD.  Conclusions:  This study tentatively supports the hypothesis that one of the mechanisms through which yoga improves mood is by increasing the activity of the GABA system. The observed increase in GABA levels following a YI that was no longer observed 8 days after a YI suggests that the associated increase in GABA after a YI is time limited such that at least one YI a week may be necessary to maintain the elevated GABA levels.",2020,GABA levels from Scan-1 to Scan-3 and from Scan-2 to Scan-3 were significantly increased in the LDG ( n  = 15) and showed a trend in the total cohort.  ,"['Subjects met criteria for MDD', 'Subjects', 'participants with major depressive disorder (MDD', 'Major Depressive Disorder']","['Iyengar yoga and coherent breathing at five breaths per minute plus homework', '12-Week Iyengar Yoga and Coherent Breathing Intervention']","['gamma aminobutyric acid (GABA) levels', 'Thalamic GABA levels', 'GABA levels', 'Scan-2 GABA levels', 'GABA', 'depressive symptoms', 'BDI-II scores', 'Beck Depression Inventory II (BDI-II) scores', 'GABA levels and the BDI-II']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441633'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",,0.0233978,GABA levels from Scan-1 to Scan-3 and from Scan-2 to Scan-3 were significantly increased in the LDG ( n  = 15) and showed a trend in the total cohort.  ,"[{'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Streeter', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Gerbarg', 'Affiliation': 'Department of Psychiatry, New York Medical College, Valhalla, NY.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Tammy M', 'Initials': 'TM', 'LastName': 'Scott', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Greylin H', 'Initials': 'GH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Sakai', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Sneider', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Maren B', 'Initials': 'MB', 'LastName': 'Nyer', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Silveri', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0234']
383,32243660,Game therapy a new approach to treat women facing mixed urinary incontinence: A study protocol.,"AIMS


To describe a pelvic floor muscle training (PFMT) isolated and associated with game therapy (PFMT + GT) for women facing mixed urinary incontinence (MUI) during climacteric period.
METHODS


To standardize a randomized controlled clinical trial intervention, a protocol was created, in an attempt to decrease women's symptomatology generated by MUI, through pelvic floor and abdomino-loin-pelvic muscles strength, and endurance. This study protocol will be composed of 32 volunteers, divided into two groups of 16. They will perform PFMT isolated or PFMT + GT, twice a week during 8 weeks. Interventions will last 40 minutes and will be divided into warming (5 minutes), training (30 minutes), and 5 minutes will be composed of resting time between exercises (1 minute each). Isolated PFMT sessions will be performed through four modalities of exercises: diaphragmatic, bridge, abdominal (plank), and pelvic mobility. PFMT + GT training will be carried out by using Wii Fit Plus games, such as Lotus Focus, Penguin Slide, Basic Step, and Hula Hoop from Wii equipment. Assessments will occur before, after, and 1 month after interventions. Vaginal manometry, 1-hour Pad Test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Patient Global Intervention (PGI) will be used to evaluate the sample.
CONCLUSIONS


It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG. Moreover, it is supposed that PFMT + GT volunteers present better treatment adherence due to games motivational inclusion.",2020,"It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG.","['32 volunteers, divided into two groups of 16', 'women facing mixed urinary incontinence', 'women facing mixed urinary incontinence (MUI) during climacteric period']","['Game therapy', 'Vaginal manometry, 1-hour Pad Test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Patient Global Intervention (PGI', 'pelvic floor muscle training (PFMT) isolated and associated with game therapy (PFMT\u2009+\u2009GT', 'PFMT\u2009+\u2009GT training']","['pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT\u2009+\u2009GG']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}]","[{'cui': 'C0454421', 'cui_str': 'Games for therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",32.0,0.0395415,"It is expected greater increase on pelvic floor muscle (PFM) strength, endurance, vaginal pressure for PFMT + GG.","[{'ForeName': 'Maria Clara Eugênia', 'Initials': 'MCE', 'LastName': 'Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Livia Oliveira', 'Initials': 'LO', 'LastName': 'Bezerra', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Priscylla Hellouyse', 'Initials': 'PH', 'LastName': 'Melo Ângelo', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maiara Costa', 'Initials': 'MC', 'LastName': 'de Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Silva-Filho', 'Affiliation': 'Graduate\xa0Program in\xa0Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Tatiana Souza', 'Initials': 'TS', 'LastName': 'Ribeiro', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate\xa0Program in\xa0Rehabilitation Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria Thereza Albuquerque Barbosa Cabral', 'Initials': 'MTABC', 'LastName': 'Micussi', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24350']
384,32248637,Investigation of optimal dose of early intervention to prevent posttraumatic stress disorder: A multiarm randomized trial of one and three sessions of modified prolonged exposure.,"BACKGROUND


Posttraumatic stress disorder (PTSD) is linked to a specific event, providing the opportunity to intervene in the immediate aftermath of trauma to prevent the development of this disorder. A previous trial demonstrated that trauma survivors who received three sessions of modified prolonged exposure therapy demonstrated decreased PTSD and depression prospectively compared to assessment only. The present study investigated the optimal dosing of this early intervention to test one versus three sessions of exposure therapy in the immediate aftermath of trauma.
METHODS


Participants (n = 95) recruited from a Level 1 Trauma Center were randomly assigned in a 1.5:1.5:1 ratio in a parallel-group design to the three conditions: one-session exposure therapy, three-session exposure therapy, and assessment only. Follow-up assessments were conducted by study assessors blind to study condition.
RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment. Results indicate that the intervention did not interfere with natural recovery. Receiver operating characteristic curve analyses on the screening measure used for study inclusion (Predicting PTSD Questionnaire; PPQ) in the larger sample from which the treatment sample was drawn (n = 481) found that the PPQ was a poor predictor of likely PTSD at all follow-up time points (Area under the curve's = 0.55-0.62).
CONCLUSIONS


This likely impacted study results as many participants demonstrated natural recovery. Recommendations for future early intervention research are reviewed, including strategies to identify more accurately those at risk for PTSD and oversampling more severe trauma types.",2020,"RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","['trauma survivors', 'Participants (n\u2009=\u200995) recruited from a Level 1 Trauma Center', 'posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD']","['early intervention', 'session exposure therapy, three-session exposure therapy, and assessment only']","['PTSD or depression symptoms', 'PTSD and depression']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.012171,"RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Maples-Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Loren M', 'Initials': 'LM', 'LastName': 'Post', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Goodnight', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Burton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carly W', 'Initials': 'CW', 'LastName': 'Yasinski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hinrichs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Alex O', 'Initials': 'AO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hudak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Houry', 'Affiliation': 'Division of Injury Prevention, National Center for Injury Control and Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Ressler', 'Affiliation': 'Department of Psychiatry, Mclean Hospital, Harvard Medical School, Belmont, Massachusetts.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}]",Depression and anxiety,['10.1002/da.23015']
385,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND


Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown.
METHODS


In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS).
RESULTS


From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96).
CONCLUSIONS


Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8']
386,32250530,"Safety, efficacy and pharmacokinetics of repeat subcutaneous dosing of avexitide (exendin 9-39) for treatment of post-bariatric hypoglycaemia.","AIM


To evaluate the safety, efficacy and pharmacokinetics of repeat dosing of two formulations of subcutaneous (SC) avexitide (exendin 9-39) in patients with post-bariatric hypoglycaemia (PBH).
METHODS


In this phase 2, multiple-ascending-dose study conducted at Stanford University, 19 women with PBH underwent a baseline oral glucose tolerance test (OGTT), with metabolic and symptomatic assessments. Fourteen were then sequentially assigned to receive one of four ascending-dose levels of twice-daily lyophilized (Lyo) avexitide by SC injection for 3 days. On the basis of safety, efficacy and tolerability, five additional participants then received a novel liquid formulation (Liq) of avexitide by SC injection at a fixed dose of 30 mg twice daily for 3 days. All 19 participants underwent a repeat OGTT on day 3 of dosing to quantify metabolic, symptomatic and pharmacokinetic responses.
RESULTS


Treatment with Lyo avexitide reduced the magnitude of symptomatic hyperinsulinaemic hypoglycaemia at all dose levels, with dose-dependent improvements in glucose nadir, insulin peak and symptom score; doses ≥20 mg twice daily did not require glycaemic rescue (administered at glucose <2.8 mmol/L). Participants receiving Liq avexitide 30 mg twice daily did not require any glycaemic rescue, and on average achieved a 47% increase in glucose nadir, a 67% reduction in peak insulin, and a 47% reduction in overall symptom score. Equivalent doses of Liq versus Lyo avexitide yielded higher and more sustained plasma concentrations. Both formulations were well tolerated.
CONCLUSIONS


In patients with PBH, twice-daily administration of SC avexitide effectively raised the glucose nadir and prevented severe hypoglycaemia requiring rescue intervention. Avexitide may represent a viable therapy for PBH.",2020,"RESULTS


Treatment with Lyo avexitide reduced the magnitude of symptomatic hyperinsulinemic hypoglycemia at all dose levels, with dose-dependent improvements in glucose nadir, insulin peak and symptom score; doses ≥20 mg BID did not require glycemic rescue (administered at glucose <50 mg/dL).","['patients with post-bariatric hypoglycemia (PBH', '19 women with PBH underwent a baseline oral glucose tolerance test (OGTT) with metabolic and symptomatic assessments', 'Fourteen participants']","['Lyo avexitide', 'subcutaneous (SC) avexitide (exendin 9-39', 'Liq avexitide', 'novel liquid formulation (Liq) of avexitide by SC injection', 'Liq vs Lyo avexitide', 'twice daily (BID) lyophilized (Lyo) avexitide by SC injection', 'Avexitide']","['tolerated', 'glycemic rescue', 'safety, efficacy, and pharmacokinetics', 'glucose nadir, insulin peak and symptom score', 'peak insulin', 'sustained plasma concentrations', 'overall symptom score', 'glucose nadir and prevented severe hypoglycemia', 'glucose nadir', 'safety, efficacy and tolerability', 'symptomatic hyperinsulinemic hypoglycemia', 'Safety, Efficacy and Pharmacokinetics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0247947', 'cui_str': 'exendin (9-39)'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1697794', 'cui_str': 'Liquid dose form'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1864903', 'cui_str': 'Hyperinsulinaemic hypoglycaemia'}]",19.0,0.0578502,"RESULTS


Treatment with Lyo avexitide reduced the magnitude of symptomatic hyperinsulinemic hypoglycemia at all dose levels, with dose-dependent improvements in glucose nadir, insulin peak and symptom score; doses ≥20 mg BID did not require glycemic rescue (administered at glucose <50 mg/dL).","[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lamendola', 'Affiliation': 'Department of Medicine, Division of Cardiology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, Division of Cardiology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'McLaughlin', 'Affiliation': 'Eiger BioPharmaceuticals, Consultant, Palo Alto, California, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Craig', 'Affiliation': 'Eiger BioPharmaceuticals, Consultant, Palo Alto, California, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14048']
387,32250534,"Effect of liraglutide on food consumption, appetite sensations and eating behaviours in overweight people with type 1 diabetes.","AIMS


To investigate the effects of 24 weeks of treatment with liraglutide added to basal/bolus insulin on energy intake, appetite sensations and eating behaviours in overweight/obese participants with type 1 diabetes (T1D).
METHODS


In a double-blinded crossover fashion, 15 participants were randomly assigned (1:1) to receive placebo or liraglutide for 24 weeks including a 1-month titration period from 0.6 to 1.2 to 1.8 mg, in addition to their insulin. The treatment was followed by a 1-month wash-out period. Participants were then assigned to the other treatment for another 24 weeks. Food intake was measured, visual analogue scales and Three-Factor Eating Questionnaires were completed. Paired rank tests were used to compare the variables.
RESULTS


When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates. Their appetite sensations were modified: fasting desire to eat, hunger and prospective food consumption were significantly reduced. The sensation of fullness was prolonged for a few hours after a standardized breakfast. Restraint and disinhibition were significantly reduced by liraglutide.
CONCLUSIONS


In this randomized clinical trial, the addition of liraglutide to basal/bolus insulin therapy for 24 weeks in overweight/obese individuals with T1D significantly improved their food consumption, appetite sensations and eating behaviours.",2020,"When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates.","['overweight/obese participants with type 1 diabetes', '24\u2009weeks in overweight/obese individuals with type 1 diabetes', 'overweight subjects with type 1 diabetes']","['placebo or liraglutide', 'liraglutide added to basal/bolus insulin', 'liraglutide to basal/bolus insulin therapy', 'liraglutide']","['fasting desire to eat, hunger and prospective food consumption', 'food consumption, appetite sensations and eating behaviours', 'visual analogue scales and Three Factor Eating Questionnaires', 'Restraint and disinhibition', 'energy intake, appetite sensations and eating behaviours', 'sensation of fullness', 'Food intake', 'total intake and % fat and increased carbohydrates']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",15.0,0.14227,"When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates.","[{'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Dubé', 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""D'Amours"", 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}, {'ForeName': 'S John', 'Initials': 'SJ', 'LastName': 'Weisnagel', 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14050']
388,32151822,A 4-item PRECISE-DAPT score for dual antiplatelet therapy duration decision-making.,"The originally-proposed PRECISE-DAPT score is a 5-item risk score supporting decision-making for dual antiplatelet therapy 1  duration after PCI. It is unknown if a simplified version of the score based on 4 factors (age, hemoglobin, creatinine clearance, prior bleeding), and lacking white-blood cell count, retains potential to guide DAPT duration. The 4-item PRECISE-DAPT was used to categorize 10,081 patients who were randomized to short (3-6 months) or long (12-24 months) DAPT regimen according to high (HBR defined by PRECISE-DAPT ≥25 points) or non-high bleeding risk (PRECISE-DAPT<25) status. Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11). Only non-HBR patients experienced lower net clinical adverse events (NACE) with longer DAPT (p int  = 0.043). A 4-item simplified version of the PRECISE-DAPT score retains the potential to categorize patients who benefit from prolonged DAPT without concomitant bleeding liability from those who do not.",2020,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","['10,081 patients who were randomized to short (3-6 months) or long (12-24 months']",['DAPT'],"['ischemic risks', 'net clinical adverse events (NACE', 'bleeding rates in HBR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0200107,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Clinical and Experimental Medicine, Policlinic ""G. Martino"", University of Messina, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Feres', 'Affiliation': 'Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital. Electronic address: marco.valgimigli@insel.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.014']
389,32179258,Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial.,"BACKGROUND


Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
METHODS


Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
CONCLUSIONS


The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.",2020,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","['Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter', 'Approximately 3,830 patients', 'coronary artery disease patients', 'patients with coronary artery disease']","['Quantitative flow ratio-guided strategy versus angiography-guided strategy', 'angiography-guided strategy will undergo PCI based on angiography', 'QFR-guided versus an angiography-guided PCI strategy', 'QFR-guided or an angiography-guided strategy', 'Quantitative flow ratio (QFR', 'percutaneous coronary intervention (PCI', 'QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy']","['efficacy and cost-effectiveness', 'individual components of MACE and cost-effectiveness end points', '1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization', '1-year MACE excluding periprocedural myocardial infarction']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}]",3830.0,0.0747895,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Daixin', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: qsbfw@sina.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.015']
390,31157652,Effects of goal-directed crystalloid vs. colloid fluid therapy on microcirculation during free flap surgery: A randomised clinical trial.,"BACKGROUND


Macro, and microcirculatory effects of crystalloids and colloids are difficult to compare, because interventions to achieve haemodynamic stability seldom follow similar criteria.
OBJECTIVES


Our aim was to compare the effects of crystalloids and colloids on the microcirculation during free flap surgery when management was guided by detailed haemodynamic assessment.
DESIGN


A randomised, controlled clinical trial.
SETTINGS


The investigation was performed at the University of Szeged, Hungary.
PATIENTS


Patients undergoing maxillofacial tumour resection and free flap reconstruction were randomised into groups treated with either intra-operative crystalloid (Ringerfundin, n = 15) or colloid (6% hydroxyethyl starch, HES, n = 15) solutions.
INTERVENTIONS


Macrohaemodynamics were monitored by a noncalibrated device (PulsioFlex-PULSION). Central venous oxygen saturation, venous-to-arterial PCO2-gap, lactate levels and urine output were measured hourly. Maintenance fluid was Ringerfundin (1 ml kg h), and a multimodal, individualised, approach-based algorithm was applied to guide haemodynamic support. Hypovolaemia was treated with Ringerfundin or HES fluid boluses, respectively. The microcirculatory effects were assessed by laser-Doppler flowmetry (PeriFlux 5000 LDPM), with the probe placed on the flap and on a control area. Measurements were performed after the flap was prepared, then 1 and 12 h later.
MAIN OUTCOME MEASURES


The primary end-point was microcirculatory perfusion as determined by laser-Doppler flowmetry.
RESULTS


There was no difference between the groups regarding patient characteristics. Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497) ml, respectively, (P = 0.011). There was no significant difference in the microcirculatory blood flow between the groups.
CONCLUSION


Our results showed that when fluid management was guided by detailed haemodynamic assessment, more crystalloid than colloid was needed to maintain haemodynamic stability, but there was no difference between the effects of crystalloids and colloids on the microcirculation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03288051.",2019,Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497),"['Patients undergoing maxillofacial tumour resection and free flap reconstruction', 'microcirculation during free flap surgery']","['Ringerfundin', 'intra-operative crystalloid (Ringerfundin, n\u200a=\u200a15) or colloid (6% hydroxyethyl starch, HES, n\u200a=\u200a15) solutions', 'goal-directed crystalloid vs. colloid fluid therapy', 'crystalloids and colloids']","['Central venous oxygen saturation, venous-to-arterial PCO2-gap, lactate levels and urine output', 'microcirculatory effects', 'microcirculatory perfusion as determined by laser-Doppler flowmetry', 'total fluid volume', 'microcirculatory blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441031', 'cui_str': 'Microsurgical Free Flaps'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C2975881', 'cui_str': 'Ringerfundin'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.165452,Both groups remained haemodynamically stable throughout due to the use of approximately a 1.5 times higher total fluid volume in the Ringerfundin group than in the HES group: mean ± SD: 2581 ± 986 and 1803 ± 497),"[{'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'László', 'Affiliation': ''}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Janovszky', 'Affiliation': ''}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Lovas', 'Affiliation': ''}, {'ForeName': 'Viktória', 'Initials': 'V', 'LastName': 'Vargán', 'Affiliation': ''}, {'ForeName': 'Nándor', 'Initials': 'N', 'LastName': 'Öveges', 'Affiliation': ''}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Tánczos', 'Affiliation': ''}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Mikor', 'Affiliation': ''}, {'ForeName': 'Domonkos', 'Initials': 'D', 'LastName': 'Trásy', 'Affiliation': ''}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Lóderer', 'Affiliation': ''}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Piffkó', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Szabó', 'Affiliation': ''}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001024']
391,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
392,32243043,Differential glycaemic control with basal insulin glargine 300 U/mL versus degludec 100 U/mL according to kidney function in type 2 diabetes: A subanalysis from the BRIGHT trial.,"AIMS


Chronic kidney disease (CKD) challenges diabetes management and is associated with increased cardiovascular morbidity and mortality. We examined whether clinical outcomes with insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) are affected by renal function in a prespecified subgroup analysis from the BRIGHT trial.
MATERIALS AND METHODS


BRIGHT (NCT02738151) was a multicentre, open-label, randomized, active-controlled, two-arm, parallel-group, 24-week study in insulin-naïve uncontrolled type 2 diabetes (T2D). Participants were randomized 1:1 to evening Gla-300 (n = 466) or IDeg-100 (n = 463) and stratified based on baseline estimated glomerular filtration rate (eGFR) for this analysis.
RESULTS


Heterogeneity of treatment effect across renal function subgroups was observed (P = .02), reflecting a greater mean glycated haemoglobin (HbA1c) reduction from baseline to week 24 with Gla-300 versus IDeg-100 in the eGFR <60 mL/min/1.73 m 2  subgroup (least squares mean difference: -0.43% [95% confidence interval: -0.74% to -0.12%]), while there were no differences in hypoglycaemia incidence or rates over 24 weeks in that subgroup. HbA1c reductions were similar between treatments in the other eGFR subgroups. However, heterogeneity was observed for annualized rates of anytime (24 hours) or nocturnal (00:00-05:59 hours) confirmed hypoglycaemia (≤70 mg/dL [≤3.9 mmol/L]) over 24 weeks showing less hypoglycaemia with Gla-300 versus IDeg-100 in the ≥90 mL/min/1.73 m 2  .
CONCLUSIONS


Kidney function seems to affect the glucose-lowering effects of Gla-300 versus IDeg-100 in insulin-naïve T2D. Greater HbA1c reductions with Gla-300 without increase in hypoglycaemia risk, were observed in patients with eGFR <60 mL/min/1.73 m 2  .",2020,over 24 weeks showing less hypoglycaemia with Gla-300 versus IDeg-100 in the ≥90,[],"['basal insulin glargine 300 U/mL versus degludec 100 U/mL', 'L', 'evening Gla-300 (n=466) or IDeg-100', 'insulin-naïve uncontrolled type 2 diabetes (T2D', 'insulin glargine 300 U/mL']","['annualised rates of anytime (24 h) or nocturnal', 'hypoglycaemia risk', 'hypoglycaemia', 'renal function subgroups', 'hypoglycaemia incidence or rates', 'cardiovascular morbidity and mortality']",[],"[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0970807,over 24 weeks showing less hypoglycaemia with Gla-300 versus IDeg-100 in the ≥90,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Cardiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Westerbacka', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Melas-Melt', 'Affiliation': 'Ividata, Levallois-Perret, France.'}, {'ForeName': 'Janaka', 'Initials': 'J', 'LastName': 'Karalliedde', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14043']
393,32238297,Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits.,"OBJECTIVE


To test the acceptability and effectiveness of a lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention for improving social connectedness among homebound older adults.
METHODS


We employed a two-site, participant-randomized controlled trial with 89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs. All participants reported loneliness; many reported being socially isolated and/or dissatisfaction with social support. Participants received five weekly videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control). Three primary outcomes were social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale. Depression severity (PHQ-9) and disability (WHODAS 2.0) were secondary outcomes. Mixed-effects regression models were fit to evaluate outcomes at 6- and 12-weeks follow-up.
RESULTS


Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
CONCLUSION


A short-term, lay-coach-facilitated Tele-BA is a promising intervention for the growing numbers of homebound older adults lacking social connectedness. The intervention holds promise for scalability in programs that already serve homebound older adults. More research is needed to solidify the clinical evidence base, cost-effectiveness and sustainability of Tele-BA delivered by lay coaches for homebound and other older adults.",2020,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
","['89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs', 'homebound older adults', 'Homebound Older Adults']","['lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention', 'videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control', 'Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits', 'lay-coach-facilitated Tele-BA']","['Depression severity (PHQ-9) and disability', 'depression', 'social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale', 'disability', 'loneliness', 'satisfaction with social support', 'social interaction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",89.0,0.0496621,"Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025).
","[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX. Electronic address: nchoi@austin.utexas.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pepin', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'The University of Texas at Austin, Steve Hicks School of Social Work (NGC, CNM), Austin, TX.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Health (RP, CJS, MLB), Hanover, NH.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.008']
394,32238795,Longitudinal effects of a nurse-managed comprehensive cardiovascular disease prevention program for hospitalized coronary heart disease patients and primary care high-risk patients.,"BACKGROUND


The EUROACTION study (nurse‑coordinated multidisciplinary, family‑based cardiovascular disease prevention program) documented the efficacy of a nurse‑managed, comprehensive prevention program in reducing risk factors for cardiovascular disease (CVD). No information was available on survival.
AIMS


The aim of the study was to assess the effects of EUROACTION intervention on CVD risk factors and 12‑year survival in the Polish component of the study.
METHODS


Two district hospitals and 2 primary care practices were allocated randomly to intervention (INT) or usual care (UC). The primary endpoints were lifestyle and risk factors changes at 1‑year follow‑up. Differences in survival were analyzed using the multivariable Cox proportional hazards regression models.
RESULTS


The study involved 628 patients with coronary heart disease (CHD) and 711 high‑risk patients. Compared to UC, INT patients achieved healthier lifestyles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after the intervention. Less deaths occurred in patients from the INT hospital and from INT primary practice (hazard ratio [HR], 0.58; 95% CI, 0.42-0.82 and HR, 0.53; 95% CI, 0.3-0.95, respectively). Adjustment for the covariates slightly attenuated the estimates and removed significance (HR, 0.74; 95% CI, 0.52-1.04 and HR, 0.66; 95% CI, 0.36-1.24, respectively). For combined CHD and high‑risk patient groups, compared with UC, INT patients had a 36% lower risk of death after adjustment for age, sex, and history of CHD (HR, 0.64; 95% CI, 0.48-0.86).
CONCLUSIONS


The impact of the EUROACTION intervention on lifestyle and CVD risk factors could have contributed to lower mortality in INT coronary and high‑risk patients. These results emphasize the need for sustaining the interventions to help patients maintain a healthy lifestyle.",2020,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","['Two district hospitals and two primary practices', '628 CHD patients and 601 high-risk patients', 'hospitalized coronary heart disease patients and primary care high-risk patients']","['nurse managed, comprehensive prevention programme', 'nurse-managed comprehensive cardiovascular disease prevention programme', 'intervention (INT) or usual care (UC']","['survival', 'healthier life styles', 'Less deaths', 'CVD risk factors', 'risk factors', 'lifestyle and risk factors changes at 1 year observation', 'risk of death']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",628.0,0.0552067,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pająk', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland. andrzej.pajak@uj.edu.pl'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolfshaut-Wolak', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Doryńska', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Jankowski', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fornal', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Kalina', 'Initials': 'K', 'LastName': 'Kawecka-Jaszcz', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Kotseva', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Pająk', 'Affiliation': 'Centre of Preventive Medicine, Kraków, Poland'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}]",Kardiologia polska,['10.33963/KP.15273']
395,31132765,Improving Toothbrushing with a Smartphone App: Results of a Randomized Controlled Trial.,"OBJECTIVES


Performing proper toothbrushing is a complicated process for children. Therefore, the aim of this study was to investigate the effect of a smartphone app for improving manual toothbrushing via a gravitation sensor.
METHODS


In this prospective, controlled, single-blinded, randomized clinical trial, 49 children (mean age 5.1 ± 0.6 years, 27 female) were randomly assigned to test (n = 26) and control (n = 23) groups. All children were provided with manual toothbrushes with an integrated gravitation sensor and they received oral health instructions. Only the children of the test group got an additional smartphone app to visualize and reward proper brushing in form and time. At baseline and recalls after 6 and 12 weeks, plaque and gingival indices (QHI, PBI) were recorded for analysis between the two groups.
RESULTS


At baseline, there were no significant differences between the test and control group regarding plaque and gingival indices (QHI: 2.36 ± 0.7 and 2.42 ± 0.8; p = 0.94; PBI: 0.42 ± 0.2 and 0.47 ± 0.3; p = 0.59). At the 6- and 12-week recalls, the test group showed statistically -significantly better oral health indices than the controls (6-week recall, QHI: 0.8 ±0.5 and 1.88 ± 0.9; p < 0.001; PBI: 0.08 ± 0.1 and 0.26 ± 0.2; p < 0.001; 12-week recall, QHI: 0.44 ± 0.5 and 1.49 ± 0.7; p < 0.001; PBI: 0.05 ± 0.18 and 0.21 ± 0.1; p < 0.001).
CONCLUSION


The results highlight the enormous possibilities of a toothbrushing application via the smartphone, at least for medium-term oral hygiene improvement in preschool children and even after excluding the app. The long-term effect should also be investigated to exclude the expected novelty effect.",2019,"At baseline, there were no significant differences between the test and control group regarding plaque and gingival indices (QHI: 2.36 ± 0.7 and 2.42 ± 0.8; p = 0.94; PBI: 0.42 ± 0.2 and 0.47 ± 0.3; p = 0.59).","['children', '49 children (mean age 5.1 ± 0.6 years, 27 female', 'preschool children']","['manual toothbrushes with an integrated gravitation sensor and they received oral health instructions', 'smartphone app']","['plaque and gingival indices (QHI, PBI', 'oral health indices', 'plaque and gingival indices']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0490733', 'cui_str': 'Manual toothbrush (physical object)'}, {'cui': 'C0018216', 'cui_str': 'Gravitation'}, {'cui': 'C0029162'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0029162'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",49.0,0.136442,"At baseline, there were no significant differences between the test and control group regarding plaque and gingival indices (QHI: 2.36 ± 0.7 and 2.42 ± 0.8; p = 0.94; PBI: 0.42 ± 0.2 and 0.47 ± 0.3; p = 0.59).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alkilzy', 'Affiliation': 'Department of Preventive and Pediatric Dentistry, University of Greifswald, Greifswald, Germany, alkilzym@uni-greifswald.de.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Midani', 'Affiliation': 'Department of Preventive and Pediatric Dentistry, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Höfer', 'Affiliation': 'Department of Preventive and Pediatric Dentistry, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Splieth', 'Affiliation': 'Department of Preventive and Pediatric Dentistry, University of Greifswald, Greifswald, Germany.'}]",Caries research,['10.1159/000499868']
396,30939472,Urinary Biomarkers of Tubular Damage Are Associated with Mortality but Not Cardiovascular Risk among Systolic Blood Pressure Intervention Trial Participants with Chronic Kidney Disease.,"BACKGROUND


Kidney tubulointerstitial fibrosis on biopsy is a strong predictor of chronic kidney disease (CKD) progression, and CKD is associated with elevated risk of cardiovascular disease (CVD). Tubular health is poorly quantified by traditional kidney function measures, including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of tubular injury, inflammation, and repair would be associated with higher risk of CVD and mortality in persons with CKD.
METHODS


We measured urinary concentrations of interleukin-18 (IL-18), kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and chitinase-3-like protein-1 (YKL-40) at baseline among 2,377 participants of the Systolic Blood Pressure Intervention Trial who had an eGFR < 60 mL/min/1.73 m2. We used Cox proportional hazards models to evaluate biomarker associations with CVD events and all-cause mortality.
RESULTS


At baseline, the mean age of participants was 72 ± 9 years, and eGFR was 48 ± 11 mL/min/1.73 m2. Over a median follow-up of 3.8 years, 305 CVD events (3.6% per year) and 233 all-cause deaths (2.6% per year) occurred. After multivariable adjustment including eGFR, albuminuria, and urinary creatinine, none of the biomarkers showed statistically significant associations with CVD risk. Urinary IL-18 (hazard ratio [HR] per 2-fold higher value, 1.14; 95% CI 1.01-1.29) and YKL-40 (HR per 2-fold higher value, 1.08; 95% CI 1.02-1.14) concentrations were each incrementally associated with higher mortality risk. Associations were similar when stratified by randomized blood pressure arm.
CONCLUSIONS


Among hypertensive trial participants with CKD, higher urinary IL-18 and YKL-40 were associated with higher risk of mortality, but not CVD.",2019,"We measured urinary concentrations of interleukin-18 (IL-18), kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and chitinase-3-like protein-1 (YKL-40) at baseline among 2,377 participants of the Systolic Blood Pressure Intervention Trial who had an eGFR < 60 mL/min/1.73 m2.","['hypertensive trial participants with CKD', 'mean age of participants was 72 ± 9\xa0years, and eGFR was 48\xa0± 11', 'persons with CKD', '2,377 participants of the Systolic Blood Pressure Intervention Trial who had an eGFR < 60 mL/min/1.73 m2', 'Trial Participants with Chronic Kidney Disease']",['Systolic Blood Pressure Intervention'],"['urinary IL-18 and YKL-40', 'urinary concentrations of interleukin-18 (IL-18), kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and chitinase-3-like protein-1 (YKL-40', 'mortality risk', 'YKL-40', 'Urinary IL-18 (hazard ratio [HR', 'eGFR, albuminuria, and urinary creatinine', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration, function (observable entity)'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",2377.0,0.218513,"We measured urinary concentrations of interleukin-18 (IL-18), kidney injury molecule-1, neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and chitinase-3-like protein-1 (YKL-40) at baseline among 2,377 participants of the Systolic Blood Pressure Intervention Trial who had an eGFR < 60 mL/min/1.73 m2.","[{'ForeName': 'Vasantha K', 'Initials': 'VK', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco VA Medical Center and University of California, San Francisco, California, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Estrella', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': 'Department of Medicine, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000499531']
397,30985537,Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial.,"BACKGROUND


Acupressure therapy is associated with favourable efficacies on postoperative nausea, pain and sleep disturbance, although the quality of the evidence is generally low. No randomised clinical trial has yet assessed the effect of acupressure on postoperative quality of recovery (QoR).
OBJECTIVE


The objective was to study acupressure efficacy on patient-reported postoperative recovery.
DESIGN


We conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints.
PATIENTS


Postoperative patients expected to stay in hospital at least 2 days after surgery.
INTERVENTIONS


In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay. In the sham group, extremely light touch was applied to the acupoints. The third group did not receive any touch.
MAIN OUTCOME MEASURES


The primary outcome was the change in the QoR, using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation.
RESULTS


Overall, 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups.
CONCLUSION


Two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier: NCT02762435.",2019,"Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively.","['163 patients', 'Postoperative patients expected to stay in hospital at least 2 days after surgery']","['acupressure therapy', 'Acupressure', 'acupressure', 'Acupressure therapy', 'postoperative acupressure therapy']","['quality of recovery', 'postoperative nausea, pain and sleep disturbance', 'Patient satisfaction', 'mean (SD) postoperative change in QoR-15', 'postoperative quality of recovery (QoR', 'change in the QoR, using the QoR-15 questionnaire', 'pain score and morphine equivalent consumption', ""patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption"", 'patient QoR, postoperative nausea and vomiting, pain score or opioid consumption', 'patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",163.0,0.540177,"Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Noll', 'Affiliation': ""From the Department of Anesthesiology, Stony Brook Medicine, Brookhaven, New York, USA (EN, SS, JLR, MCM, CP, DS, XG, TJG, EB-G), Department of Anesthesiology and Intensive Care, Hôpitaux Universitaires de Strasbourg (EN), Institut de Chirurgie guidée par l'image, IHU Hôpitaux Universitaires de Strasbourg, Strasbourg, France (EN) and Department of Surgery, Stony Brook Medicine, Brookhaven, New York, USA (ADP).""}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Shodhan', 'Affiliation': ''}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Romeiser', 'Affiliation': ''}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Madariaga', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Page', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Santangelo', 'Affiliation': ''}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Aurora D', 'Initials': 'AD', 'LastName': 'Pryor', 'Affiliation': ''}, {'ForeName': 'Tong J', 'Initials': 'TJ', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Bennett-Guerrero', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001001']
398,32228710,Haploidentical donor is preferred over matched sibling donor for pre-transplantation MRD positive ALL: a phase 3 genetically randomized study.,"BACKGROUND


Previous reports suggest a benefit associated with haploidentical donor transplantation (HIDT) compared to matched sibling donor transplantation (MSDT) in certain contexts, and the choice of optimal candidates warrants further investigation.
METHODS


We designed a prospective genetically randomized study to evaluate donor options between acute lymphoblastic leukemia (ALL) patients positive for measurable residual disease (MRD) pre-transplantation who underwent HIDT (n = 169) or MSDT (n = 39).
RESULTS


The cumulative incidence of positive MRD post-transplantation was 26% (95% CI, 19-33%) and 44% (95% CI, 28-60%) for HIDT and MSDT, respectively (P = 0.043). Compared to the HIDT cohort, the MSDT cohort had a higher 3-year cumulative incidence of relapse (CIR; 47%, 95% CI, 31-63% vs. 23%, 95% CI, 17-29%; P = 0.006) and lower 3-year probability of leukemia-free survival (LFS; 43%, 95% CI, 27-59% vs. 65%, 95% CI, 58-72%; P = 0.023) and overall survival (OS; 46%, 95% CI, 30-62% vs. 68%, 95% CI, 61-75%; P = 0.039), without a difference in non-relapse-mortality (10%, 95% CI, 1-19% vs. 11%, 95% CI, 6-16%; P = 0.845). Multivariate analysis showed that HIDT is associated with a low CIR (HR = 0.364; 95% CI, 0.202-0.655; P = 0.001) and better LFS (HR = 0.414; 95% CI, 0.246-0.695; P = 0.001) and OS (HR = 0.380; 95% CI, 0.220-0.656; P = 0.001).
CONCLUSIONS


HIDT is better than MSDT in view of favorable anti-leukemia activity for patients with pre-transplantation MRD positive ALL. The current study paves the way to determine that haploidentical donors are the preferred choice regardless of available matched sibling donors in a subgroup population.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02185261. Registered July 9, 2014. https://clinicaltrials.gov/ct2/show/NCT02185261?term=NCT02185261&draw=2&rank=1.",2020,"The cumulative incidence of positive MRD post-transplantation was 26% (95% CI, 19-33%) and 44% (95% CI, 28-60%) for HIDT and MSDT, respectively (P = 0.043).",['acute lymphoblastic leukemia (ALL) patients positive for measurable residual disease (MRD) pre-transplantation who underwent HIDT (n = 169) or MSDT (n = 39'],['haploidentical donor transplantation (HIDT'],"['3-year probability of leukemia-free survival', 'non-relapse-mortality', '3-year cumulative incidence of relapse', 'overall survival', 'cumulative incidence of positive MRD post-transplantation']","[{'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",,0.454273,"The cumulative incidence of positive MRD post-transplantation was 26% (95% CI, 19-33%) and 44% (95% CI, 28-60%) for HIDT and MSDT, respectively (P = 0.043).","[{'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Lan-Ping', 'Initials': 'LP', 'LastName': 'Xu', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Feng-Rong', 'Initials': 'FR', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Wei-Han', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Yu-Qian', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Chen-Hua', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Fei-Fei', 'Initials': 'FF', 'LastName': 'Tang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Mo', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Yan-Rong', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Kai-Yan', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, People's Republic of China. xjhrm@medmail.com.cn.""}]",Journal of hematology & oncology,['10.1186/s13045-020-00860-y']
399,30707210,Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial.,"OBJECTIVE


s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients.
DESIGN


Randomized controlled trial.
SETTING


Three tertiary care PICUs in the United States.
PATIENTS


Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours.
INTERVENTIONS


Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32).
MEASUREMENTS AND MAIN RESULTS


Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes.
CONCLUSIONS


A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.",2019,More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001).,"['children', 'Pediatric Neurocritical Care Patients', 'Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours', 'Three tertiary care PICUs in the United States', 'pediatric neurocritical care patients']","['Early Protocolized Versus Usual Care Rehabilitation', 'physical therapy, occupational therapy, and speech and language therapy', 'Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72\u2009hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32', 'ICU-based rehabilitative services']","['functional or quality of life outcomes', 'consultation timing, treatment type, and frequency of deferrals and safety events', 'patient and family functional and quality of life outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",58.0,0.0556068,More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001).,"[{'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Houtrow', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Richichi', 'Affiliation': 'Statistical Analysis and Measurement Consultants Inc., Lanexa, VA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Burns', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Doughty', 'Affiliation': ""Division of Critical Care Medicine, Department of Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ortiz-Aguayo', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Madurski', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Valenta', 'Affiliation': 'Professional Practice and Education, Jefferson Hospital, Jefferson Hills, PA.'}, {'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Chrisman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Golightly', 'Affiliation': ""Audiology Communications Disorders, Department of Audiology and Speech-Language Pathology, UPMC Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kiger', 'Affiliation': ""Division of Occupational Therapy and Physical Therapy, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Patrick', 'Affiliation': ""Departments of Occupational and Physical Therapy, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Amery', 'Initials': 'A', 'LastName': 'Treble-Barna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pollon', 'Affiliation': 'Special Needs Child Advocate and Study Stakeholder, Pittsburgh, PA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Smith', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kochanek', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001881']
400,32164906,"Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


The triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab showed improved outcomes for patients with metastatic colorectal cancer, compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. However, the actual benefit of the upfront exposure to the three cytotoxic drugs compared with a preplanned sequential strategy of doublets was not clear, and neither was the feasibility or efficacy of therapies after disease progression. We aimed to compare a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI doublets, in combination with bevacizumab.
METHODS


TRIBE2 was an open-label, phase 3, randomised study of patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units. Patients were stratified according to centre, ECOG performance status, primary tumour location, and previous adjuvant chemotherapy. A randomisation system incorporating a minimisation algorithm was used to randomly assign patients (1:1) via a masked web-based allocation procedure to two different treatment strategies. In the control group, patients received first-line mFOLFOX6 (85 mg/m 2  of intravenous oxaliplatin concurrently with 200 mg/m 2  of leucovorin over 120 min; 400 mg/m 2  intravenous bolus of fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab (5 mg/kg intravenously over 30 min) followed by FOLFIRI (180 mg/m 2  of intravenous irinotecan over 120 min concurrently with 200 mg/m 2  of leucovorin; 400 mg/m 2  intravenous bolus of fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab after disease progression. In the experimental group, patients received FOLFOXIRI (165 mg/m 2  of intravenous irinotecan over 60 min; 85 mg/m 2  intravenous oxaliplatin concurrently with 200 mg/m 2  of leucovorin over 120 min; 3200 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab followed by the reintroduction of the same regimen after disease progression. Combination treatments were repeated every 14 days for up to eight cycles followed by fluorouracil and leucovorin (at the same dose administered at the last induction cycle) plus bevacizumab maintenance until disease progression, unacceptable adverse events, or consent withdrawal. Patients and investigators were not masked. The primary endpoint was progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat. Safety was assessed in patients who received at least one dose of their assigned treatment. Study recruitment is complete and follow-up is ongoing. This trial is registered with Clinicaltrials.gov, NCT02339116.
FINDINGS


Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group). At data cut-off (July 30, 2019) median follow-up was 35·9 months (IQR 30·1-41·4). Median progression-free survival 2 was 19·2 months (95% CI 17·3-21·4) in the experimental group and 16·4 months (15·1-17·5) in the control group (hazard ratio [HR] 0·74, 95% CI 0·63-0·88; p=0·0005). During the first-line treatment, the most frequent of all-cause grade 3-4 events were diarrhoea (57 [17%] vs 18 [5%]), neutropenia (168 [50%] vs 71 [21%]), and arterial hypertension (25 [7%] vs 35 [10%]) in the experimental group compared with the control group. Serious adverse events occurred in 84 (25%) patients in the experimental group and in 56 (17%) patients in the control group. Eight treatment-related deaths were reported in the experimental group (two intestinal occlusions, two intestinal perforations, two sepsis, one myocardial infarction, and one bleeding) and four in the control group (two occlusions, one perforation, and one pulmonary embolism). After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients). Serious adverse events after disease progression occurred in 20 (15%) patients in the experimental group and 25 (12%) in the control group. Three treatment-related deaths after first disease progression were reported in the experimental group (two intestinal occlusions and one sepsis) and four in the control group (one intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis).
INTERPRETATION


Upfront FOLFOXIRI plus bevacizumab followed by the reintroduction of the same regimen after disease progression seems to be a preferable therapeutic strategy to sequential administration of chemotherapy doublets, in combination with bevacizumab, for patients with metastatic colorectal cancer selected according to the study criteria.
FUNDING


The GONO Cooperative Group, the ARCO Foundation, and F Hoffmann-La Roche.",2020,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","['patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units', 'Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group', 'patients with metastatic colorectal cancer selected according to the study criteria', 'patients with metastatic colorectal cancer (TRIBE2', 'patients with metastatic colorectal cancer']","['first-line mFOLFOX6', 'FOLFOXIRI', 'intravenous irinotecan', 'fluorouracil and leucovorin', 'Upfront FOLFOXIRI plus bevacizumab', 'FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab', 'leucovorin', 'fluorouracil', 'FOLFIRI (180 mg/m 2  of intravenous irinotecan', 'mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin', 'fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil', 'bevacizumab', 'FOLFIRI plus bevacizumab', 'mFOLFOX6 plus bevacizumab', 'triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab', 'oxaliplatin']","['Median progression-free survival', 'intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis', 'intestinal perforations, two sepsis, one myocardial infarction, and one bleeding', 'diarrhoea', 'progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat', 'Serious adverse events', 'incidence of grade 3 or 4 adverse events', 'neutropenia', 'neurotoxicity', 'Safety', 'Serious adverse events after disease progression', 'arterial hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4553808', 'cui_str': 'Intestinal occlusion'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0580351', 'cui_str': 'Treatment given'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",679.0,0.0771876,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy; Oncology and Hemato-oncology Department, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Oncology Unit, Foundation IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi, Rimini, Italy; Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital, Tricase, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grande', 'Affiliation': 'Department of Medical Oncology, F Spaziani Hospital, Lazio, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Aprile', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy; Department of Oncology, San Bortolo General Hospital, Vicenza, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Murgioni', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Department of Oncology, S Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Department of Medical Oncology, IRCCS, Centro di Riferimento Oncologico National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moretto', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Antonuzzo', 'Affiliation': 'Medical Oncology Unit, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Medical Oncology Unit, Azienda Socio-Sanitaria Territoriale of Cremona, Cremona Hospital, Cremona, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Department of Oncology, Hospital San Raffaele, IRCCS, Milan, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Department of Medical Oncology, General Hospital, Prato, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carlomagno', 'Affiliation': 'Department of Clinical Medicine and Surgery, University Federico II, Napoli, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Medical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Ritorto', 'Affiliation': 'Struttura Semplice Dipartimentale, ColoRectal Cancer Unit, Department of Oncology, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mambrini', 'Affiliation': 'Oncological Department, Azienda UnitàSanitaria Locale, Toscana Nord Ovest, Oncological Unit of Massa Carrara, Carrara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Roselli', 'Affiliation': 'Department of Systems Medicine, Medical Oncology Unit, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Cupini', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Azienda Toscana Nord Ovest, Livorno, Italy.'}, {'ForeName': 'Serafina', 'Initials': 'S', 'LastName': 'Mammoliti', 'Affiliation': 'Medical Oncology, IRCCS, Ospedale San Martino Istituto Scientifico Tumori, Genoa, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Fenocchio', 'Affiliation': ""Department of Medical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Italy.""}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Corgna', 'Affiliation': 'Unit of Medical Oncology, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ugolini', 'Affiliation': 'Department of Laboratory, Pathology section, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Toscano Cancer Institute, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy. Electronic address: alfredo.falcone@med.unipi.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30862-9']
401,32166831,Pharmacokinetics of an intravenous bolus dose of clonidine in children undergoing surgery.,"BACKGROUND


Clonidine is used off-label in children but only limited pediatric pharmacokinetic data are available for intravenously administered clonidine.
OBJECTIVES


To determine pharmacokinetic parameter estimates of clonidine in healthy children undergoing surgery and to investigate age-related differences. Furthermore, to investigate possible pharmacokinetic differences of clonidine between this group of children and a cohort with cardiac diseases.
METHODS


In a randomized placebo-controlled trial (The PREVENT AGITATION trial), blood samples for clonidine pharmacokinetic analysis were collected in a proportion of the enrolled patients. Healthy children with ASA score 1-2 in the age-groups 1 to <2 years and 2-5 years were randomized for blood sampling. Clonidine was administered as a single intravenous bolus of 3 µg/kg intraoperatively. Blood samples were drawn at baseline, 5, 10, 15, 30, 60 minutes after dosing and additionally every hour until discharge from the PACU. Clonidine analysis was performed on liquid chromatography-mass spectrometry.
RESULTS


Data form eighteen children were available for pharmacokinetic analysis (ASA I; male/female: 17/1; age: 1-5 years; weight 8.7-24 kg). Population parameter estimates for the 2-compartment model were similar to previous published data for children who underwent cardiac surgery. A pooled analysis including data from 59 children indicated clearance of 14.4 L h -1   70 kg -1  and volume of distribution of 192.6 L 70 kg -1  . No age-related pharmacokinetic differences and no difference in time from administration of study medication to awakening were found. Children 1 to <2 years had a shorter PACU stay than children 2-5 years (mean difference 17% 95% CI:3%-34%, P = .02).
CONCLUSION


Pharmacokinetic parameter estimates were similar for children undergoing general surgery and cardiac surgery given a single dose of intravenous clonidine. These results indicated that no dose reduction is needed in children aged 1 to <2 years compared with those 2-5 years, which was supported by pharmacodynamic observations.",2020,"Children 1 to <2 years had a shorter PACU stay than children 2 to 5 years (mean difference 17% 95% CI:3-34%, p=0.02).
","['children who underwent cardiac surgery', 'children and a cohort with cardiac diseases', 'proportion of the enrolled patients', 'children undergoing general surgery and cardiac surgery', 'eighteen children were available for pharmacokinetic analysis (ASA I; male/female: 17/1; age: 1 to 5 years; weight 8.7-24 kg', 'children undergoing surgery', '59 children indicated clearance of 14.4 L.h -1  .70kg -1  and volume of distribution of 192.6 L.70 kg -1  ', 'healthy children undergoing surgery and to investigate age-related differences', 'Healthy children with ASA score 1-2 in the age-groups 1 to <2 years and 2 to 5 years']","['Clonidine', 'placebo', 'clonidine']",['shorter PACU stay'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}]",18.0,0.418842,"Children 1 to <2 years had a shorter PACU stay than children 2 to 5 years (mean difference 17% 95% CI:3-34%, p=0.02).
","[{'ForeName': 'Bettina N', 'Initials': 'BN', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Falcon', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steen W', 'Initials': 'SW', 'LastName': 'Henneberg', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritsen', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lomstein', 'Affiliation': 'Center for Laboratory, Food and Environmental Technology, The Business Academy Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Ydemann', 'Affiliation': 'Department of Neuroanaethestesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Paediatric anaesthesia,['10.1111/pan.13856']
402,32232790,Detection of emergent large vessel occlusion stroke with CT angiography is high across all levels of radiology training and grayscale viewing methods.,"OBJECTIVES


CT angiography (CTA) is essential in acute stroke to detect emergent large vessel occlusions (ELVO) and must be interpreted by radiologists with and without subspecialized training. Additionally, grayscale inversion has been suggested to improve diagnostic accuracy in other radiology applications. This study examines diagnostic performance in ELVO detection between neuroradiologists, non-neuroradiologists, and radiology residents using standard and grayscale inversion viewing methods.
METHODS


A random, counterbalanced experimental design was used, where 18 radiologists with varying experiences interpreted the same patient images with and without grayscale inversion. Confirmed positive and negative ELVO cases were randomly ordered using a balanced design. Sensitivity, specificity, positive and negative predictive values as well as confidence, subjective assessment of image quality, time to ELVO detection, and overall interpretation time were examined between grayscale inversion (on/off) by experience level using generalized mixed modeling assuming a binary, negative binomial, and binomial distributions, respectively.
RESULTS


All groups of radiologists had high sensitivity and specificity for ELVO detection (all > .94). Neuroradiologists were faster than non-neuroradiologists and residents in interpretation time, with a mean of 47 s to detect ELVO, as compared with 59 and 74 s, respectively. Residents were subjectively less confident than attending physicians. With respect to grayscale inversion, no differences were observed between groups with grayscale inversion vs. standard viewing for diagnostic performance (p = 0.30), detection time (p = .45), overall interpretation time (p = .97), and confidence (p = .20).
CONCLUSIONS


Diagnostic performance in ELVO detection with CTA was high across all levels of radiologist training level. Grayscale inversion offered no significant detection advantage.
KEY POINTS


• Stroke is an acute vascular syndrome that requires acute vascular imaging. • Proximal large vessel occlusions can be identified quickly and accurately by radiologists across all training levels. • Grayscale inversion demonstrated minimal detectable benefit in the detection of proximal large vessel occlusions.",2020,"Neuroradiologists were faster than non-neuroradiologists and residents in interpretation time, with a mean of 47 s to detect ELVO, as compared with 59 and 74 s, respectively.","['positive and negative ELVO cases', '18 radiologists with varying experiences interpreted the same patient images with and without grayscale inversion']","['CT angiography (CTA', 'CT angiography']","['diagnostic accuracy', 'Neuroradiologists', 'diagnostic performance', 'Sensitivity, specificity, positive and negative predictive values as well as confidence, subjective assessment of image quality, time to ELVO detection, and overall interpretation time', 'detection time', 'overall interpretation time', 'sensitivity and specificity for ELVO detection']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0260194', 'cui_str': 'Radiologist (occupation)'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0675377,"Neuroradiologists were faster than non-neuroradiologists and residents in interpretation time, with a mean of 47 s to detect ELVO, as compared with 59 and 74 s, respectively.","[{'ForeName': 'Chelsea A', 'Initials': 'CA', 'LastName': 'Boyd', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Grayson L', 'Initials': 'GL', 'LastName': 'Baird', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA. GBaird@Lifespan.org.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Einhorn', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stib', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Atalay', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Boxerman', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Lourenco', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Jindal', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Hidlay', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Eleanor L', 'Initials': 'EL', 'LastName': 'DiBiasio', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'Department of Diagnostic Imaging, Warren Alpert School of Medicine at Brown University, 593 Eddy Street, Room 302, Providence, RI, 02903, USA.'}]",European radiology,['10.1007/s00330-020-06814-9']
403,32112738,"Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial.","BACKGROUND


Blocking the interaction between PD-1 and its ligands is a promising treatment strategy for advanced hepatocellular carcinoma. This study aimed to assess the antitumour activity and safety of the anti-PD-1 inhibitor camrelizumab in pretreated patients with advanced hepatocellular carcinoma.
METHODS


This is a multicentre, open-label, parallel-group, randomised, phase 2 trial done at 13 study sites in China. Eligible patients were aged 18 years and older with a histological or cytological diagnosis of advanced hepatocellular carcinoma, had progressed on or were intolerant to previous systemic treatment, and had an Eastern Cooperative Oncology Group performance score of 0-1. Patients were randomly assigned (1:1) to receive camrelizumab 3 mg/kg intravenously every 2 or 3 weeks, via a centralised interactive web-response system using block randomisation (block size of four). The primary endpoints were objective response (per blinded independent central review) and 6-month overall survival, in all randomly assigned patients who had at least one dose of study treatment. Safety was analysed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02989922, and follow-up is ongoing, but enrolment is closed.
FINDINGS


Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for eligibility, of whom 220 eligible patients were randomly assigned and among whom 217 received camrelizumab (109 patients were given treatment every 2 weeks and 108 every 3 weeks). Median follow-up was 12·5 months (IQR 5·7-15·5). Objective response was reported in 32 (14·7%; 95% CI 10·3-20·2) of 217 patients. The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)]. Grade 3 or 4 treatment-related adverse events occurred in 47 (22%) of 217 patients; the most common were increased aspartate aminotransferase (ten [5%]) and decreased neutrophil count (seven [3%]). Two deaths were judged by the investigators to be potentially treatment-related (one due to liver dysfunction and one due to multiple organ failure).
INTERPRETATION


Camrelizumab showed antitumour activity in pretreated Chinese patients with advanced hepatocellular carcinoma, with manageable toxicities, and might represent a new treatment option for these patients.
FUNDING


Jiangsu Hengrui Medicine.",2020,The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)].,"['pretreated Chinese patients with advanced hepatocellular carcinoma', 'Eligible patients were aged 18 years and older with a histological or cytological diagnosis of advanced hepatocellular carcinoma, had progressed on or were intolerant to previous systemic treatment, and had an Eastern Cooperative Oncology Group performance score of 0-1', 'Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for eligibility, of whom 220 eligible patients', 'pretreated patients with advanced hepatocellular carcinoma', '13 study sites in China', 'patients with previously treated advanced hepatocellular carcinoma', 'advanced hepatocellular carcinoma']","['camrelizumab', 'camrelizumab 3 mg/kg intravenously every 2 or 3 weeks, via a centralised interactive web-response system using block randomisation (block size of four', 'Camrelizumab', 'anti-PD-1 inhibitor camrelizumab']","['Objective response', 'neutrophil count', 'objective response (per blinded independent central review) and 6-month overall survival', 'antitumour activity', 'overall survival probability', 'adverse events', 'aspartate aminotransferase', 'antitumour activity and safety', 'Safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.351536,The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)].,"[{'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Centre of Jinling Hospital, Nanjing, China. Electronic address: qinsk@csco.org.cn.'}, {'ForeName': 'Zhenggang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Minimally Invasive Therapy Center, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Intervention, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Third Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Medical Oncology, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Interventional Radiology, Cancer Center, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, First Affiliated Hospital of Xi'an Jiaotong University (School of Medicine), Xi'an, China.""}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30011-5']
404,31822848,Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial.,"PURPOSE


To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.
METHODS


A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.
RESULTS


Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (-2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) CONCLUSIONS: The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.",2020,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","['Participants (n\u2009=\u2009133) were predominantly White/European (74%), female (90%), and ≥50 years old (60']","['Genomics ADvISER (www.genomicsadviser.com) decision aid (DA', 'DA followed by discussion with a genetic counselor, or to genetic counseling alone', 'genetic counseling alone']","['knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session', 'counseling time and improved knowledge', 'knowledge of sequencing limitations', 'knowledge of SF', 'shorter counseling time', 'anxiety', 'Decisional conflict', 'decisional conflict']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",133.0,0.134204,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Theresa H M', 'Initials': 'THM', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Muir', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0702-z']
405,32236818,The effects of nigella sativa on anthropometric and biochemical indices in postmenopausal women with metabolic syndrome.,"PURPOSE


This study aimed to compare the nigella sativa vs. placebo effect on anthropometric and biochemical indices in postmenopausal women with metabolic syndrome.
METHODS


This randomized, double-blinded, placebo-controlled trial was conducted as a third-phase trial among 140 menopausal women within the age of 45-60 years old, who were suffering from metabolic syndrome and were assigned to receive 500 mg nigella sativa or placebo pill once daily. Anthropometric and biochemical parameters including body weight, waist circumference, serum lipid profile, fasting blood sugar, and HbA1C were measured at baseline and 8 weeks after administration the ingredient or placebo.
RESULTS


In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
CONCLUSION


Administration of nigella sativa might be recommended for improving lipid profile and blood sugar in postmenopausal women with the metabolic syndrome.",2020,"In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
","['140 menopausal women within the age of 45-60 years old, who were suffering from metabolic syndrome', 'postmenopausal women with the metabolic syndrome', 'postmenopausal women with metabolic syndrome']","['500\u2009mg nigella sativa or placebo pill once daily', 'nigella sativa', 'placebo']","['fasting blood sugar', 'triglyceride', 'total cholesterol', 'lipid profile and blood sugar', 'serum markers such as low-density lipoprotein', 'body weight, waist circumference, serum lipid profile, fasting blood sugar, and HbA1C']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",140.0,0.54455,"In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Khodakarami', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Feizabad', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Ghaemi', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran. marjan_ghaemi@yahoo.com.'}]",Endocrine,['10.1007/s12020-020-02265-w']
406,31821220,"Psychological Function, Iyengar Yoga, and Coherent Breathing: A Randomized Controlled Dosing Study.","BACKGROUND


Evidence suggests that yoga may be an effective treatment for major depressive disorder (MDD). Studies evaluating the ""dosing"" of yoga treatment and efficacy for MDD are needed. The goal of this study was to assess the effects of an intervention combining Iyengar yoga and coherent breathing in participants with MDD and determine the optimal intervention dose.
METHODS


Thirty-two participants (18 to 65 y of age) diagnosed with MDD were randomized to a high-dose group (HDG) or a low-dose group (LDG) of yoga and coherent breathing for 12 weeks. The HDG (n=15) involved three 90-minute yoga classes and four 30-minute homework sessions per week. The LDG (n=15) involved two 90-minute yoga classes and three 30-minute homework sessions per week. Participants were evaluated at baseline, week 4, week 8, and week 12 with the following instruments: Positivity Self-Test, Spielberger State Anxiety Inventory, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index, and Exercise-induced Feeling Inventory. Data were analyzed using intent-to-treat methods.
RESULTS


Significant improvements in all outcome measures were found for both groups, with acute and cumulative benefits. Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size. Cumulative yoga minutes were correlated with improvement in outcome measures.
LIMITATION


This dosing study did not include a non-yoga control.
CONCLUSIONS


Improvement in psychological symptoms correlated with cumulative yoga practice. Both interventions reduced symptoms of depression and anxiety and increased feelings of positivity. The time commitment for yoga practice needs to be weighed against benefits when designing yoga interventions.",2019,"Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size.","['Thirty-two participants (18 to 65\u2009y of age) diagnosed with MDD', 'participants with MDD and determine the optimal intervention dose', 'major depressive disorder (MDD']","['LDG', 'intervention combining Iyengar yoga and coherent breathing', 'HDG', 'high-dose group (HDG) or a low-dose group (LDG) of yoga and coherent breathing', 'Psychological Function, Iyengar Yoga, and Coherent Breathing']","['symptoms of depression and anxiety and increased feelings of positivity', 'Positivity Self-Test, Spielberger State Anxiety Inventory, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index, and Exercise-induced Feeling Inventory']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",32.0,0.0762643,"Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size.","[{'ForeName': 'Tammy M', 'Initials': 'TM', 'LastName': 'Scott', 'Affiliation': 'SCOTT: Department of Psychiatry, Boston University School of Medicine, and Department of Psychiatry, Boston Medical Center, Friedman School of Nutrition Science and Policy, Tufts University, and Tufts University School of Medicine, Boston, MA GERBARG: Department of Psychiatry, New York Medical College, Valhalla, NY SILVERI: Department of Psychiatry, Harvard School of Medicine, Boston, MA, and Department of Psychiatry, McLean Hospital, Belmont, MA NIELSEN and OWEN: Departments of Psychiatry and Neurology, Boston University School of Medicine, Boston, MA NYER: Department of Psychiatry, Harvard School of Medicine, and Department of Psychiatry, Massachusetts General Hospital, Boston, MA BROWN: Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY STREETER: Departments of Psychiatry and Neurology, Boston University School of Medicine, Department of Psychiatry, Harvard School of Medicine, and Department of Psychiatry, Boston Medical Center, Boston, MA, Department of Psychiatry, McLean Hospital, Belmont, MA, and Department of Psychiatry, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Gerbarg', 'Affiliation': ''}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Silveri', 'Affiliation': ''}, {'ForeName': 'Greylin H', 'Initials': 'GH', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Nyer', 'Affiliation': ''}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Streeter', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000435']
407,32232481,Prognostic value of interim FDG-PET in diffuse large cell lymphoma: results from the CALGB 50303 Clinical Trial.,"As part of a randomized, prospective clinical trial in large cell lymphoma, we conducted serial fluorodeoxyglucose positron emission tomography (FDG-PET) at baseline, after 2 cycles of chemotherapy (interim PET [i-PET]), and at end of treatment (EoT) to identify biomarkers of response that are predictive of remission and survival. Scans were interpreted in a core laboratory by 2 imaging experts, using the visual Deauville 5-point scale (5-PS), and by calculating percent change in FDG uptake (change in standardized uptake value [ΔSUV]). Visual scores of 1 through 3 and ΔSUV ≥66% were prospectively defined as negative. Of 524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis. In this selected population, all had FDG-avid disease at baseline; by 5-PS, 55 (35%) remained positive on i-PET and 28 (18%) on EoT PET. Median ΔSUV on i-PET was 86.2%. With a median follow-up of 5 years, ΔSUV, as continuous variable, was associated with progression-free survival (PFS) (hazard ratio [HR] = 0.99; 95% confidence interval [CI], 0.97-1.00; P = .02) and overall survival (OS) (HR, 0.98; 95% CI, 0.97-0.99; P = .03). ΔSUV ≥66% was predictive of OS (HR, 0.31; 95% CI, 0.11-0.85; P = .02) but not PFS (HR, 0.47; 95% CI, 0.19-1.13; P = .09). Visual 5-PS on i-PET did not predict outcome. ΔSUV, but not visual analysis, on i-PET predicted OS in DLBCL, although the low number of events limited the statistical analysis. These data may help guide future clinical trials using PET response-adapted therapy. This trial was registered at www.clinicaltrials.gov as #NCT00118209.",2020,Visual 5-PS on i-PET did not predict outcome.,"['Large Cell Lymphoma', '524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis']",[],"['predictive of OS', 'overall survival (OS', 'FDG uptake (ΔSUV', 'Median ΔSUV', 'Visual scores', 'visual 5-point scale (5-PS', 'progression-free survival (PFS']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",524.0,0.472593,Visual 5-PS on i-PET did not predict outcome.,"[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': 'Department Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Knopp', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Department Radiology, Philadelphia VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Kostakoglu', 'Affiliation': 'Department Radiology, Mt. Sinai Medical Center, New York, NY.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Howard R', 'Initials': 'HR', 'LastName': 'Higley', 'Affiliation': 'CCS Associates, Inc., San Jose, CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kelloff', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Department Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Department Medicine, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'Department Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department Laboratory Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department Radiology, Columbia University Medical Center, New York, NY; and.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': 'Lymphoid Malignancies Branch, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Blood,['10.1182/blood.2019003277']
408,32171426,"Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study.","BACKGROUND


CLEOPATRA was a phase 3 study comparing the efficacy and safety of pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer. In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group. Here, we report the end-of-study analysis of CLEOPATRA.
METHODS


This was a double-blind, randomised, placebo-controlled, phase 3 trial that was done at 204 centres in 25 countries. Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All study drugs were given intravenously, every 3 weeks. Patients were assigned to receive either pertuzumab or placebo at a loading dose of 840 mg, and 420 mg thereafter; plus trastuzumab at 8 mg/kg loading dose and 6 mg/kg thereafter; and docetaxel at 75 mg/m 2 , escalating to 100 mg/m 2  if tolerated. Pertuzumab or placebo and trastuzumab were given until disease progression; docetaxel was given for six cycles, or longer at the investigators' discretion. Randomisation (1:1) was done by use of an interactive voice-response system and was stratified by geographical region (Asia, Europe, North America, or South America) and previous treatment (previous adjuvant or neoadjuvant chemotherapy vs none). The primary endpoint was independent review facility-assessed progression-free survival, which has been reported previously. Since the confirmatory overall survival analysis had also occurred before this prespecified end-of-study analysis, analyses presented here are descriptive. Overall survival analyses were based on the intention-to-treat population with crossover patients analysed in the placebo group; analyses were not adjusted for crossover to the pertuzumab group and are likely to be conservative. Safety analyses were based on treatment received; crossover patients were counted in the placebo group up to the day before first pertuzumab dose. This trial is registered with ClinicalTrials.gov, number NCT00567190.
FINDINGS


Between Feb 12, 2008, and July 7, 2010, 1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned. 402 patients were assigned to receive docetaxel plus trastuzumab plus pertuzumab, and 406 patients were assigned to receive docetaxel plus trastuzumab plus placebo. Clinical cutoff for this analysis was Nov 23, 2018. Between July 2012 and clinical cutoff, 50 patients crossed from the placebo to the pertuzumab group. Median follow-up was 99·9 months in the pertuzumab group (IQR 92·9-106·4) and 98·7 months (90·9-105·7) in the placebo group. Median overall survival was 57·1 months (95% CI 50-72) in the pertuzumab group and 40·8 months (36-48) in the placebo group (hazard ratio 0·69, 95% CI 0·58-0·82); 8-year landmark overall survival rates were 37% (95% CI 31-42) in the pertuzumab group and 23% (19-28) in the placebo group. The most common grade 3-4 adverse event was neutropenia (200 [49%] of 408 patients in the pertuzumab group, 183 [46%] of 396 patients in the placebo group). Five (1%) of 408 patients in the pertuzumab group and six (2%) of 396 patients in the placebo group had treatment-related deaths. One new serious adverse event suggestive of congestive heart failure (pertuzumab group) and one new symptomatic left ventricular systolic dysfunction (post-crossover) occurred since the previous analysis.
INTERPRETATION


Our analysis shows that the previously observed improvements in overall survival with pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel were maintained after a median of more than 8 years of follow-up. The long-term safety and cardiac safety profiles of pertuzumab, trastuzumab, and docetaxel were maintained in the overall safety population and within crossover patients. HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","['1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned', 'patients with HER2-positive metastatic breast cancer', 'HER2-positive metastatic breast cancer (CLEOPATRA', ' and 406 patients', 'Between Feb 12, 2008, and July 7, 2010', '204 centres in 25 countries', 'Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1', '402 patients']","['pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel', 'trastuzumab', 'docetaxel plus trastuzumab\u2008plus\u2008placebo', 'docetaxel plus trastuzumab\u2008plus\u2008pertuzumab', 'HER2-targeted therapy', 'placebo', 'pertuzumab or placebo', 'docetaxel', 'pertuzumab, trastuzumab, and docetaxel', 'Pertuzumab or placebo and trastuzumab', 'pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel', 'Pertuzumab, trastuzumab, and docetaxel']","['overall survival', 'treatment-related deaths', '8-year landmark overall survival rates', 'Overall survival analyses', 'Median overall survival', 'neutropenia', 'progression-free and overall survival', 'review facility-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0323987', 'cui_str': 'Cleopatra'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1531518', 'cui_str': 'Biological treatment'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1196.0,0.69218,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Georgetown University Medical Center, Washington DC, USA; Lombardi Comprehensive Cancer Center, Washington, DC, USA; MedStar Health, Washington, DC, USA. Electronic address: sandra.swain@georgetown.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Semiglazov', 'Affiliation': 'N N Petrov Research Institute of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': '12 de Octubre University Hospital, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Monturus', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Knott', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Benyunes', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quirónsalud Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30863-0']
409,32171429,"Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial.","BACKGROUND


With increasingly precise radiotherapy and advanced medical imaging, the concept of radiotherapy target volume planning might be redefined with the aim of improving outcomes. We aimed to investigate whether target volume reduction is feasible and effective compared with conventional planning in the context of radical chemoradiotherapy for patients with locally advanced non-small-cell lung cancer.
METHODS


We did a multicentre, open-label, randomised, controlled trial (PET-Plan; ARO-2009-09) in 24 centres in Austria, Germany, and Switzerland. Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included. Undergoing  18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT for treatment planning, patients were randomly assigned (1:1) using a random number generator and block sizes between four and six to target volume delineation informed by  18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group). Randomisation was stratified by centre and Union for International Cancer Control stage. In both groups, dose-escalated radiotherapy (60-74 Gy, 2 Gy per fraction) was planned to the respective target volumes and applied with concurrent platinum-based chemotherapy. The primary endpoint was time to locoregional progression from randomisation with the objective to test non-inferiority of  18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25. The per-protocol set was included in the primary analysis. The safety set included all patients receiving any study-specific treatment. Patients and study staff were not masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT00697333.
FINDINGS


From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients were randomly assigned to the conventional target group (n=99) or the  18 F-FDG PET-based target group (n=106; the intention-to-treat set), and 172 patients were treated per protocol (84 patients in the conventional target group and 88 in the  18 F-FDG PET-based target group). At a median follow-up of 29 months (IQR 9-54), the risk of locoregional progression in the  18 F-FDG PET-based target group was non-inferior to, and in fact lower than, that in the conventional target group in the per-protocol set (14% [95% CI 5-21] vs 29% [17-38] at 1 year; HR 0·57 [95% CI 0·30-1·06]). The risk of locoregional progression in the  18 F-FDG PET-based target group was also non-inferior to that in the conventional target group in the intention-to-treat set (17% [95% CI 9-24] vs 30% [20-39] at 1 year; HR 0·64 [95% CI 0·37-1·10]). The most common acute grade 3 or worse toxicity was oesophagitis or dysphagia (16 [16%] of 99 patients in the conventional target group vs 17 [16%] of 105 patients in the  18 F-FDG PET-based target group); the most common late toxicities were lung-related (12 [12%] vs 11 [10%]). 20 deaths potentially related to study treatment were reported (seven vs 13).
INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer. Imaging-based target volume reduction in this setting is, therefore, feasible, and could potentially be considered standard of care. The procedures established might also support imaging-based target volume reduction concepts for other tumours.
FUNDING


German Cancer Aid (Deutsche Krebshilfe).",2020,"INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","['locally advanced non-small-cell lung cancer (PET-Plan', 'patients with locally advanced non-small-cell lung cancer', '24 centres in Austria, Germany, and Switzerland', 'From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients', 'Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included', 'patients receiving any study-specific treatment', 'patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer']","['conventional planning', 'Imaging-based target volume reduction in chemoradiotherapy', 'concurrent platinum-based chemotherapy', 'conventional target group (n=99) or the  18 F-FDG PET-based target group', 'radiotherapy', 'radical chemoradiotherapy', 'random number generator and block sizes between four and six to target volume delineation informed by  18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group', 'Undergoing  18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT']","['toxicity was oesophagitis or dysphagia', 'time to locoregional progression from randomisation with the objective to test non-inferiority of  18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25', 'risk of locoregional progression', 'toxicity', 'late toxicities']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",311.0,0.27767,"INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany; Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany. Electronic address: ursula.nestle@mariahilf.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, Wuppertal, Germany; Department of Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thieme', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Department of Radiation Oncology, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Medical University of Vienna, Vienna General Hospital, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'H Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30013-9']
410,32045662,"The experiences of EMS providers taking part in a large randomised trial of airway management during out of hospital cardiac arrest, and the impact on their views and practice. Results of a survey and telephone interviews.","AIMS


To explore EMS experiences of participating in a large trial of airway management during out-of-hospital cardiac arrest (AIRWAYS-2), specifically to explore: 1. Any changes in views and practice as a result of trial participation. 2. Experiences of trial training. 3. Experiences of enrolling critically unwell patients without consent. 4. Barriers and facilitators for out-of-hospital trial participation.
METHODS


An online questionnaire was distributed to 1523 EMS providers who participated in the trial. In-depth telephone interviews explored the responses to the online questionnaire. Quantitative data were collated and presented using simple descriptive statistics. Qualitative data collected during the online survey were analysed using content analysis. Interpretive Phenomenological Analysis was used for qualitative interview data.
RESULTS


Responses to the online questionnaire were received from 33% of the EMS providers who participated in AIRWAYS-2, and 19 providers were interviewed. EMS providers described barriers and facilitators to trial participation and changes in their views and practice. The results are presented in five distinct themes: research process; changes in airway management views and practice; engagement with research; professional identity; professional competence.
CONCLUSIONS


Participation in the AIRWAYS-2 trial was enjoyable and EMS providers valued the study training and support. There was enhanced confidence in airway management as a result of taking part in the trial. EMS providers indicated existing variability in training, experience and confidence in tracheal intubation, and expressed a preference for the method of airway management to which they had been randomised. There was support for the stepwise approach to airway management, but also concern regarding the potential loss of tracheal intubation from 'standard' EMS practice. The views and practices of the EMS providers expressed in this research will usefully inform the design of future similar trials.",2020,"RESULTS


Responses to the online questionnaire were received from 33% of the EMS providers who participated in AIRWAYS-2, and 19 providers were interviewed.","['Experiences of enrolling critically unwell patients without consent', '1523 EMS providers who participated in the trial']",[],[],"[{'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",[],[],,0.0579971,"RESULTS


Responses to the online questionnaire were received from 33% of the EMS providers who participated in AIRWAYS-2, and 19 providers were interviewed.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kirby', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, BS16 1DD, United Kingdom; South Western Ambulance Service NHS Foundation Trust, Abbey Court, Eagle Way, Exeter, EX2 7HY, United Kingdom. Electronic address: Kim.Kirby@uwe.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brandling', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, BS16 1DD, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Abbey Court, Eagle Way, Exeter, EX2 7HY, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Marlborough Street, Bristol, BS1 3NU, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Voss', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, BS16 1DD, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benger', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, BS16 1DD, United Kingdom; University Hospitals Bristol NHS Foundation Trust, Marlborough Street, Bristol, BS1 3NU, United Kingdom.'}]",Resuscitation,['10.1016/j.resuscitation.2020.01.034']
411,32239442,Are Videos or Text Better for Describing Attributes in Stated-Preference Surveys?,"OBJECTIVE


In stated-preference research, the conventional approach to describing study attributes is through text, often with easy-to-understand graphics. More recently, researchers have begun to present attribute descriptions and content in videos. Some experts have expressed concern regarding internalization and retention of information conveyed via video.
OBJECTIVE


Our study aimed to compare respondents' understanding of attribute information provided via text versus video.
METHODS


Potential respondents were randomized to receive a text or video version of the survey. In the text version, all content was provided in text format along with still graphics. In the video version, text content was interspersed with four video clips, providing the same information as the text version. In both versions, 10 questions were embedded to assess respondents' understanding of the information presented relating to ovarian cancer treatments. Half of the questions were on treatment benefits and the other half were on treatment-related risks. Some questions asked about the decision context and definitions of treatment features, and others asked about the graphic presentation of treatment features. Preferences for ovarian cancer treatments were also compared between respondents receiving text versus video versions.
RESULTS


Overall, 150 respondents were recruited. Of the 95 who were eligible and completed the survey, 54 respondents received the text version and 41 received the video version. Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01). Both groups spent an average of 35 min completing the survey. On the first comprehension question, 43% in the text arm and 61% in the video arm provided the correct response (p = 0.08). Although the mean number of correct responses was significantly higher in the video versus text arms (9.1 vs. 8.6, p = 0.02), there were no systematic differences in preferences between arms.
CONCLUSIONS


The quality of stated-preference data relies on respondents' understanding of study content. Information provided via video may better engage survey participants and improve their retention of content.",2020,"Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01).","['150 respondents were recruited', 'Of the 95 who were eligible and completed the survey, 54 respondents received the', 'Potential respondents']",['text version and 41 received the video version'],"['mean number of correct responses', 'Median times to completion', 'correct response']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",150.0,0.0611263,"Median times to completion were 24 and 30 min in the video and text arms, respectively (p < 0.01).","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jui-Chen', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Ehrisman', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Havrilesky', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA. shelby.reed@duke.edu.'}]",The patient,['10.1007/s40271-020-00416-9']
412,32228133,Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center.,"OBJECTIVES


Despite the safety and efficacy of the human papillomavirus (HPV) vaccine, many persons are still not receiving it. The purpose of this pilot project was to evaluate the number of first doses of the 9-valent HPV (9vHPV) vaccination administered after a pharmacist-led intervention in the Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia.
METHODS


The pilot project had 3 phases: pre-intervention (November 15, 2016, through March 31, 2017), active intervention (November 15, 2017, through December 29, 2017), and post-intervention (December 30, 2017, through March 31, 2018). The pre-intervention phase was used as a historical control. The active intervention phase consisted of pharmacist interventions in the clinic and patient and health care provider education. The post-intervention phase evaluated the durability of pharmacist-led interventions performed and education provided during the active phase.
RESULTS


Eighty-nine first-dose 9vHPV vaccines (of the 3-dose series) were administered to young adults aged 18-26 during the project period (November 15, 2017, through March 31, 2018); none were administered during the pre-intervention phase. Of 89 patients who received a first 9vHPV vaccine dose, 20 patients also received a second 9vHPV vaccine dose. During the project period, 166 doses of 9vHPV vaccine (first, second, or third doses) were administered.
CONCLUSION


This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series. With the support of other health care providers, pharmacist-led initiatives can expand vaccine-related health literacy and facilitate access to immunization services.",2020,This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series.,"['Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia', 'Eighty-nine first-dose 9vHPV vaccines (of the 3-dose series) were administered to young adults aged 18-26 during the project period (November 15, 2017, through March 31, 2018); none were administered during the pre-intervention phase', '89 patients who received a first', 'Human Papillomavirus', 'Ambulatory Clinic at a Large Academic Urban Medical Center']","['9-valent HPV (9vHPV) vaccination', '9vHPV vaccine dose', 'pharmacist interventions', 'human papillomavirus (HPV) vaccine', 'Pharmacist-Led Intervention', '9vHPV vaccine']",['Vaccination'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0352415,This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series.,"[{'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Cebollero', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Walton', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Cavendish', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Quairoli', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cwiak', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Kottke', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920914340']
413,32068436,"Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial.","Background:  SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog ® /NovoRapid ®  (NN-Asp). This study investigated whether the efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 months in people with type 1 ( n  = 497) or type 2 diabetes ( n  = 100) treated with multiple daily injections in combination with insulin glargine (Lantus ® ), are maintained after 12 months.  Materials and Methods:  GEMELLI 1 was a multicenter, randomized, open-label, phase 3 study. Participants completing the initial 6-month treatment period continued on SAR-Asp or NN-Asp, as randomized, for a 6-month safety extension.  Results:  Of the 597 participants randomized, 264 out of 301 (87.7%) and 263 out of 296 (88.9%) assigned to SAR-Asp and NN-Asp, respectively, completed 12 months of treatment. Improved glycemic control was sustained at 12 months in both treatment groups, with similar least-squares mean reductions in glycated hemoglobin (HbA1c) from baseline (SAR-Asp: -0.25%; NN-Asp: -0.26%). Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages were similar between groups. Safety and tolerability, including anti-insulin aspart antibodies (AIAs; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, and treatment-emergent adverse events (including hypersensitivity events and injection site reactions), were similar between groups. No relationship was observed between maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions or between efficacy/safety measures and subgroups by presence or absence of treatment-emergent AIA.  Conclusions:  SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months of treatment.",2020,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"['people with type 1 (T1D, n=497) or type 2 diabetes (T2D, n=100) treated with', 'people with diabetes over 12 months treatment', 'People with Diabetes also Using Insulin Glargine']","['Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart', 'multiple daily injections in combination with insulin glargine (Lantus®']","['maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions', 'glycemic control', 'Safety and tolerability, including anti-insulin aspart antibodies (AIA; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, treatment-emergent adverse events (including hypersensitivity events and injection site reactions', 'efficacy and safety (including immunogenicity', 'Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",597.0,0.0510182,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"[{'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wernicke-Panten', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warszawa, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kramer', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Delalande', 'Affiliation': 'Ividata, Paris, France.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warszawa, Poland.'}, {'ForeName': 'Karita', 'Initials': 'K', 'LastName': 'Sadeharju', 'Affiliation': 'Terveystalo Seinäjoki, Seinäjoki, Finland.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Monchamp', 'Affiliation': 'Endocrinology Services Northwest, Bend, Oregon.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Miossec', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0008']
414,32223601,One-Year Evaluation of a Targeted Medication Therapy Management Intervention for Older Adults.,"BACKGROUND


Older adults are especially susceptible to adverse effects of inappropriate medication therapy, and anticholinergic medications are common culprits for cognitive dysfunction due to their action on the central nervous system. Medication therapy management (MTM) interventions can aid in deprescribing and reducing inappropriate medication use in older adults. However, there is sparse literature on the long-term sustainability of these interventions.
OBJECTIVES


To (a) investigate whether the deprescribing of anticholinergic medications during an 8-week randomized controlled trial (RCT) of a targeted MTM intervention is sustained at 1-year postintervention follow-up and (b) compare anticholinergic utilization trends in the study population with a large sample of similar individuals not exposed to the intervention.
METHODS


Participants in the targeted MTM (tMTM) RCT had normal cognition or mild cognitive impairment and were recruited from enrollees in a longitudinal study at the University of Kentucky Alzheimer's Disease Center (ADC) and thus have pertinent medical information gathered approximately annually. In this posttrial observational follow-up, sustainability of the anticholinergic deprescribing intervention was assessed in participants in the RCT, and anticholinergic medication use trends were described from the RCT baseline (which occurred immediately following an ADC visit) to the next annual visit in all participants. Mean change in anticholinergic burden from RCT baseline to the next annual visit was estimated using analysis of covariance, and participants were compared with 2 external samples. Anticholinergic burden was measured using the Anticholinergic Drug Scale (ADS). The odds of decreasing baseline anticholinergic burden and number of total and strong anticholinergic medications at the follow-up study time point was assessed using logistic regression.
RESULTS


Of the deprescribing changes made during the initial RCT, 50% were sustained after 1 year. Participants in the tMTM trial reported decreases in the use of anticholinergic antihistamines and bladder agents (-6.5 and -4.4%, respectively), but there was no change in the use of anticholinergic agents targeted at the central nervous system. While the anticholinergic burden of RCT participants decreased over 1 year (adjusted mean ADS change [95% CI] = -0.33 [-0.72, 0.07]), it was not different than the change observed in 2 external samples at the trial center (-0.20 [-0.42, 0.02]) and nationally (-0.33 [-0.39, -0.26]). There were no statistically significant differences between trial participants and external samples in the odds of decreasing anticholinergic burden nor in decreasing the number of total, or strongly anticholinergic, medications at the 1-year follow-up.
CONCLUSIONS


This study demonstrates that the sustainability of deprescribing is limited to the period of intervention, rather than affording lasting effects even over periods as short as 1 year, which was demonstrated not only in the small group of RCT participants but also by comparison with external groups. Future work should extend the duration of intervention and follow-up periods for MTM interventions to allow further insights regarding the sustainability of deprescribing efforts in older adults.
DISCLOSURES


The original trial was supported by a pilot study award from the University of Kentucky Center for Clinical and Translational Sciences (UL1TR000117). Additional support for this study was provided by the National Institutes of Health/National Institute on Aging (R01 AG054130). Jicha reports contract research for Esai, Biohaven, Alltech, Suven, Novartis, and Lilly. The other authors have nothing to disclose.",2020,Medication therapy management (MTM) interventions can aid in deprescribing and reducing inappropriate medication use in older adults.,"['Older adults', ""Participants in the targeted MTM (tMTM) RCT had normal cognition or mild cognitive impairment and were recruited from enrollees in a longitudinal study at the University of Kentucky Alzheimer's Disease Center (ADC) and thus have pertinent medical information gathered approximately annually"", 'older adults', 'Older Adults', 'study population with a large sample of similar individuals not exposed to the intervention']","['Targeted Medication Therapy Management Intervention', 'Medication therapy management (MTM) interventions', 'anticholinergic medications', 'MTM intervention']","['number of total, or strongly anticholinergic, medications', 'baseline anticholinergic burden and number of total and strong anticholinergic medications', 'Anticholinergic Drug Scale (ADS', 'anticholinergic antihistamines and bladder agents', 'Anticholinergic burden']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition (finding)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0222045'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",,0.0365253,Medication therapy management (MTM) interventions can aid in deprescribing and reducing inappropriate medication use in older adults.,"[{'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Martinez', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Abner', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Kentucky, and Sanders-Brown Center on Aging, Lexington, Kentucky.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Jicha', 'Affiliation': 'Sanders-Brown Center on Aging, Lexington, Kentucky, and Department of Neurology, College of Medicine, University of Kentucky, Lexington.'}, {'ForeName': 'Dorinda N', 'Initials': 'DN', 'LastName': 'Rigsby', 'Affiliation': 'Medical Center, Lexington, Kentucky.'}, {'ForeName': 'Lynne C', 'Initials': 'LC', 'LastName': 'Eckmann', 'Affiliation': 'Pharmacy Consulting Services, Lexington, Kentucky.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Huffmyer', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, and PRO2RX LLC Pharmacy Consulting Services, Lexington, Kentucky.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Moga', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, and Department of Epidemiology, College of Public Health, University of Kentucky, and Sanders-Brown Center on Aging, Lexington, Kentucky.'}]",Journal of managed care & specialty pharmacy,['10.18553/jmcp.2020.26.4.520']
415,32234715,Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.,"OBJECTIVE


Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up.
METHODS


This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study.
RESULTS


From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE -0.62±0.18, p=0.0006), WOMAC Physical Function (-0.71±0.17, p<0.0001) and PGA-OA (-0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo.
CONCLUSION


Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups.
TRIAL REGISTRATION NUMBER


NCT02709486.",2020,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","['osteoarthritis of the hip or knee', 'From March 2016 to December 2017, 849 patients were randomised and evaluated ', 'phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics']","['placebo n=282, tanezumab 2.5\u2009mg n=283, tanezumab', 'placebo', 'tanezumab', 'Tanezumab', 'tanezumab 2.5 mg or 5\u2009mg subcutaneously or matching placebo', 'Subcutaneous tanezumab']","['RPOA', 'paraesthesia', 'pain, physical function and PGA-OA', 'WOMAC Physical Function', 'Rapidly progressive osteoarthritis (RPOA', 'Total joint replacements (TJRs', 'WOMAC Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index', 'Joint safety and neurological assessments', 'WOMAC Pain and Physical Function', ""WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA""]","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",849.0,0.0446766,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France francis.berenbaum@aphp.fr.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Faculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Junor', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Carey', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216296']
416,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
417,32032087,Can an Integrative Care Approach Improve Physical Function Trajectories after Orthopaedic Trauma? A Randomized Controlled Trial.,"BACKGROUND


Orthopaedic trauma patients frequently experience mobility impairment, fear-related issues, self-care difficulties, and work-related disability []. Recovery from trauma-related injuries is dependent upon injury severity as well as psychosocial factors []. However, traditional treatments do not integrate psychosocial and early mobilization to promote improved function, and they fail to provide a satisfying patient experience.
QUESTIONS/PURPOSES


We sought to determine (1) whether an early psychosocial intervention (integrative care with movement) among patients with orthopaedic trauma improved objective physical function outcomes during recovery compared with usual care, and (2) whether an integrative care approach with orthopaedic trauma patients improved patient-reported physical function outcomes during recovery compared with usual care.
METHODS


Between November 2015 and February 2017, 1133 patients were admitted to one hospital as orthopaedic trauma alerts to the care of the three orthopaedic trauma surgeons involved in the study. Patients with severe or multiple orthopaedic trauma requiring one or more surgical procedures were identified by our orthopaedic trauma surgeons and approached by study staff for enrollment in the study. Patients were between 18 years and 85 years of age. We excluded individuals outside of the age range; those with diagnosis of a traumatic brain injury []; those who were unable to communicate effectively (for example, at a level where self-report measures could not be answered completely); patients currently using psychotropic medications; or those who had psychotic, suicidal, or homicidal ideations at time of study enrollment. A total of 112 orthopaedic trauma patients were randomized to treatment groups (integrative and usual care), with 13 withdrawn (n = 99; 58% men; mean age 44 years ± 17 years). Data was collected at the following time points: baseline (acute hospitalization), 6 weeks, 3 months, 6 months, and at 1 year. By 1-year follow-up, we had a 75% loss to follow-up. Because our data showed no difference in the trajectories of these outcomes during the first few months of recovery, it is highly unlikely that any differences would appear months after 6 months. Therefore, analyses are presented for the 6-month follow-up time window. Integrative care consisted of usual trauma care plus additional resources, connections to services, as well as psychosocial and movement strategies to help patients recover. Physical function was measured objectively (handgrip strength, active joint ROM, and Lower Extremity Gain Scale) and subjectively (Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS®-PF] and Tampa Scale of Kinesiophobia). Higher values for hand grip, Lower Extremity Gain Scale (score range 0-27), and PROMIS®-PF (population norm = 50) are indicative of higher functional ability. Lower Tampa Scale of Kinesiophobia (score range 11-44) scores indicate less fear of movement. Trajectories of these measures were determined across time points.
RESULTS


We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β = -0.0792 [95% confidence interval -0.292 to 0.133]; p = 0.46; left handgrip strength β = -0.133 [95% CI -0.384 to 0.119]; p = 0.30), or Lower Extremity Gain Scale score (β = -0.0303 [95% CI -0.191 to 0.131]; p = 0.71). The only differences between usual care and integrative care in active ROM achieved by final follow-up within the involved extremity was noted in elbow flexion, with usual care group 20° ± 10° less than integrative care (t [27] = -2.06; p = 0.05). Patients treated with usual care and integrative care showed the same Tampa Scale of Kinesiophobia score trajectories (β = 0.0155 [95% CI -0.123 to 0.154]; p = 0.83).
CONCLUSION


Our early psychosocial intervention did not change the trajectory of physical function recovery compared with usual care. Although this specific intervention did not alter recovery trajectories, these interventions should not be abandoned because the greatest gains in function occur early in recovery after trauma, which is the key time in transition to home. More work is needed to identify ways to capitalize on improvements earlier within the recovery process to facilitate functional gains and combat psychosocial barriers to recovery.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β,"['112 orthopaedic trauma patients were randomized to treatment groups (integrative and usual care), with 13 withdrawn (n = 99; 58% men; mean age 44 years ± 17 years', 'patients with orthopaedic trauma', 'Patients were between 18 years and 85 years of age', '1133 patients were admitted to one hospital as orthopaedic trauma alerts to the care of the three orthopaedic trauma surgeons involved in the study', 'individuals outside of the age range; those with diagnosis of a traumatic brain injury [28]; those who were unable to communicate effectively (for example, at a level where self-report measures could not be answered completely); patients currently using psychotropic medications; or those who had psychotic, suicidal, or homicidal ideations at time of study enrollment', 'Between November 2015 and February 2017', 'Patients with severe or multiple orthopaedic trauma requiring one or more surgical procedures were identified by our orthopaedic trauma surgeons and approached by study staff for enrollment in the study']",['early psychosocial intervention (integrative care with movement'],"['Physical Function Trajectories', 'objective physical function outcomes', 'Higher values for hand grip, Lower Extremity Gain Scale', 'same Tampa Scale of Kinesiophobia score trajectories', 'handgrip strength (right handgrip strength β', 'objectively (handgrip strength, active joint ROM, and Lower Extremity Gain Scale) and subjectively (Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS®-PF] and Tampa Scale of Kinesiophobia', 'Lower Extremity Gain Scale score', 'Lower Tampa Scale of Kinesiophobia (score range 11-44) scores indicate less fear of movement', 'Physical function', 'active ROM', 'PROMIS®-PF']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0586908', 'cui_str': 'Trauma surgeon (occupation)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0566000', 'cui_str': 'Unable to communicate (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0455204', 'cui_str': 'Homicidal thoughts (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",1133.0,0.0714295,We found no differences at 6 months follow-up between usual care and integrative care in terms of handgrip strength (right handgrip strength β,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zdziarski-Horodyski', 'Affiliation': 'L. Zdziarski-Horodyski, T. Vasilopoulos, MB. Horodyski, J. E. Hagen, K. H. Sadasivan, S. Sharififar, M. Patrick, H. K. Vincent, Department of Orthopaedics and Rehabilitation, University of Florida, Gainesville, FL, USA L. Zdziarski-Horodyski, Department of Orthopaedics and Sports Medicine, University of Utah, Salt Lake City, UT, USA T. Vasilopoulos, Department of Anesthesia, University of Florida, Gainesville, FL, USA R. Guenther, Department of Clinical Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Vasilopoulos', 'Affiliation': ''}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Horodyski', 'Affiliation': ''}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Hagen', 'Affiliation': ''}, {'ForeName': 'Kalia S', 'Initials': 'KS', 'LastName': 'Sadasivan', 'Affiliation': ''}, {'ForeName': 'Sharareh', 'Initials': 'S', 'LastName': 'Sharififar', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Patrick', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guenther', 'Affiliation': ''}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001140']
418,32039956,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001164']
419,31898198,Sitting or Walking? Analyzing the Neural Emotional Indicators of Urban Green Space Behavior with Mobile EEG.,"There is a close relationship between urban green space and the physical and mental health of individuals. Most previous studies have discussed the impact of the structure of green space and its elements. This study focused on the emotional changes caused by common behaviors in urban green space (walking and sitting). We recruited 40 college students and randomly assigned them to walking and sitting groups (20 students per group). The two groups performed the same 8-min high-pressure learning task indoors and then performed 8-min recovery activities in a simulated urban green space (a bamboo-lawn space). We used the Emotiv EPOC+ EEG headset to dynamically measure six neural emotional parameters: ""engagement,"" ""valence,"" ""meditation,"" ""frustration,"" ""focus,"" and ""excitement."" We conducted a pretest and posttest and used analysis of covariance (ANCOVA) to analyze the posttest data (with the pretest data as covariates). The results of the comparison of the two behaviors showed that the ""valence"" and ""meditation"" values of the walking group were higher than those of the sitting group, which suggests that walking in urban green space is more favorable for stress reduction. The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration. The results of this study can provide guidance for urban green space planning and design as well as health guidance for urban residents.",2020,"The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration.","['urban residents', '40 college students', 'urban green space (walking and sitting']",['Emotiv EPOC+ EEG headset'],"['valence"" and ""meditation"" values']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0150277'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.0202801,"The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China. cqb@sicau.edu.cn.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Zongfang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Linjia', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Qiuyuan', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-019-00407-8']
420,32058423,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'S. Das, Assistant Professor, Orthopaedics, Rajendra Institute of Medical Sciences (RIMS), Ranchi, India.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001163']
421,31891860,Acute alcohol intake alters resting state functional connectivity of nucleus accumbens with pain-related corticolimbic structures.,"BACKGROUND


The nucleus accumbens (NAc) is a ventral striatal structure underlying reward, reinforcement, and motivation, with extensive anatomic and functional connections to a wide range of affective processing structures (medial prefrontal cortex (mPFC), amygdala, and insula). Characterizing how acute alcohol intake affects resting state functional connectivity (rsFC) between the nucleus accumbens (NAc) and these regions will improve mechanistic understanding of alcohol's neurobehavioral effects, including the neural overlap between acute alcohol effects and pain processing.
METHODS


Fifteen healthy social drinkers (10 women; age: 25-45 years) were included in the study. Participants completed one session in which they consumed an alcohol dose targeting a breath alcohol concentration of 0.08 g/dL, and in a second a placebo beverage. Nine-minute resting state fMRI scans were acquired 30-35 min after beverage administration during each session. rsFC between NAc and a priori corticolimbic regions of interest (mPFC, amgydala, and insula), were compared between beverage conditions. We also conducted an exploratory whole-brain seed-to-voxel analysis of NAc FC.
RESULTS


Alcohol intake reduced rsFC between NAc and mPFC, as well as NAc and amygdala. Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex.
CONCLUSIONS


Findings suggest that acute alcohol intake reduces rsFC between NAc and several structures, including mPFC, amygdala, and rostral ACC in healthy social drinkers. These structures underlie reward, motivated behavior, and emotion regulation, and may provide mechanistic insight to how alcohol affects related processes, including pain.",2020,"Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex.
","['healthy social drinkers', 'Fifteen healthy social drinkers (10 women; age: 25-45 years']","['Acute alcohol intake', 'placebo beverage']",[],"[{'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]",[],15.0,0.0751021,"Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex.
","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA. Electronic address: jboissoneault@phhp.ufl.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stennett', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107811']
422,32167483,Effectiveness of a Mobile eHealth App in Guiding Patients in Pain Control and Opiate Use After Total Knee Replacement: Randomized Controlled Trial.,"BACKGROUND


Little is known about pain and opiate use at home directly after total knee replacement (TKR). Due to adverse effects, low opiate use is desired. An electronic health app (PainCoach) was developed to guide patients in pain control and opiate use.
OBJECTIVE


The aim of this paper was to investigate the effects of the PainCoach app on pain control and opiate use in patients who underwent TKR during the first 2 weeks at home after surgery.
METHODS


In an unblinded randomized controlled trial, patients scheduled for TKR were offline recruited and randomized to a PainCoach group or control group. In the PainCoach group, the PainCoach app was downloaded on each patient's smartphone or tablet. In response to the patient's input of the pain experienced, the PainCoach app gave advice on pain medication use, exercises/rest, and when to call the clinic. This advice was the same as that received during usual care. The control group received usual care. The primary outcomes were opiate use and visual analog scale (VAS) pain scores at rest, during activity, and at night during the first 2 weeks at home after surgery, which were collected daily from day 1 until 14 postoperatively by online questionnaires. The actual amount of app use was recorded, and active use was defined as ≥12 total app uses.
RESULTS


The pain scores did not differ between the groups. The PainCoach group (n=38) used 23.2% less opiates (95% CI -38.3 to -4.4; P=.02) and 14.6% more acetaminophen (95% CI 8.2-21.3; P<.001) when compared with the findings in the control group (n=33). The PainCoach app was used 12 (IQR 4.5-22.0) times per patient. In the active PainCoach subgroup (n=19), the following were noted when compared with the findings in the control group: 4.1 times faster reduction of the VAS pain score during activity (95% CI -7.5 to -0.8; P=.02), 6.3 times faster reduction of the VAS pain score at night (95% CI -10.1 to -2.6; P=.001), 44.3% less opiate use (95% CI -59.4 to -23.5; P<.001), 76.3% less gabapentin use (95% CI -86.0 to -59.8; P<.001), and 21.0% more acetaminophen use (95% CI 12.6-30.0; P<.001).
CONCLUSIONS


The use of the PainCoach app contributes to reduced opiate use in the initial period at home after TKR. Active use of this app leads to a further reduction in opiate use and improved pain control.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03961152; https://clinicaltrials.gov/ct2/show/NCT03961152.",2020,The use of the PainCoach app contributes to reduced opiate use in the initial period at home after TKR.,"['patients who underwent TKR during the first 2 weeks at home after surgery', 'patients scheduled for TKR']","['Mobile eHealth App', 'PainCoach group or control group', 'electronic health app (PainCoach', 'usual care', 'PainCoach', 'acetaminophen', 'gabapentin']","['VAS pain score', 'pain scores', 'Pain Control and Opiate Use', 'pain control and opiate use', 'opiate use and visual analog scale (VAS) pain scores at rest, during activity, and at night during the first 2 weeks at home after surgery', 'VAS pain score during activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.118537,The use of the PainCoach app contributes to reduced opiate use in the initial period at home after TKR.,"[{'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Pronk', 'Affiliation': 'Research Department, Kliniek ViaSana, Mill, Netherlands.'}, {'ForeName': 'Maud Cornelia Wilhelmina Maria', 'Initials': 'MCWM', 'LastName': 'Peters', 'Affiliation': 'Research Department, Kliniek ViaSana, Mill, Netherlands.'}, {'ForeName': 'Amarsing', 'Initials': 'A', 'LastName': 'Sheombar', 'Affiliation': 'Department of Anaesthesiology, Kliniek ViaSana, Mill, Netherlands.'}, {'ForeName': 'Justus-Martijn', 'Initials': 'JM', 'LastName': 'Brinkman', 'Affiliation': 'Department of Orthopaedic Surgery, Kliniek ViaSana, Mill, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/16415']
423,32175908,Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes.,"BACKGROUND


Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking.
OBJECTIVE


The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes.
METHODS


The pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample t test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants' classified usage of capABILITY.
RESULTS


Pre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: P=.03; exercise: P=.005; and blood glucose: P=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (P=.008) and exercise (P=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message.
CONCLUSIONS


Our theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089.",2020,"Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message.
","['20 patients with type 2 diabetes', 'individuals with diabetes', 'two cohorts recruited as employees from within a health care system']","['text) messages integrate components from social cognitive theory (SCT), FBM']",['self-efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",20.0,0.0855742,"Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message.
","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sittig', 'Affiliation': 'School of Computing, University of South Alabama, Mobile, AL, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Iyengar', 'Affiliation': 'College of Medicine Phoenix, The University of Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Sahiti', 'Initials': 'S', 'LastName': 'Myneni', 'Affiliation': 'School of Biomedical Informatics, University of Texas Health Science Center Houston, Houston, TX, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Franklin', 'Affiliation': 'School of Biomedical Informatics, University of Texas Health Science Center Houston, Houston, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/15927']
424,32227613,Semaglutide improves health-related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6).,"AIM


To assess what drives change in health-related quality of life (HRQoL) in type 2 diabetes in the SUSTAIN 6 trial and identify potential mediators of the treatment effect of semaglutide on HRQoL scores.
MATERIALS AND METHODS


The Short Form (SF)-36v2® questionnaire [comprising physical component summary (PCS) and mental component summary (MCS)] was used to assess changes in HRQoL from baseline to week 104, by treatment, in a prespecified analysis. This post-hoc analysis assessed change in PCS and MCS using the following factors as parameter/covariate, using descriptive statistics and linear regressions: major adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in glycated haemoglobin (HbA1c), body weight, blood pressure, heart rate and estimated glomerular filtration rate.
RESULTS


Mean change in overall PCS score was +1.0 with semaglutide versus +0.4 with placebo, and +0.5 versus -0.2 for MCS. The treatment effect of semaglutide versus placebo (unadjusted estimate) was 0.7 [(95% confidence interval 0.1, 1.2); P = 0.018] on PCS and this was reduced when adjusted for change in HbA1c [0.4 (-0.2, 1.0), P = .167] and body weight [0.3 (-0.3, 0.9), P = .314]. The unadjusted treatment effect on MCS [0.7 (-0.0, 1.5), P = .054] was only reduced when adjusted for change in HbA1c [0.3 (-0.4, 1.1), P = .397]. When adjusting for all other parameters separately, the estimated effect of semaglutide on PCS and MCS qualitatively did not change.
CONCLUSIONS


Semaglutide improved HRQoL versus placebo; greater improvements with semaglutide versus placebo were possibly mediated, in part, by change in HbA1c and body weight. Clinicaltrials.gov: NCT01720446 (SUSTAIN 6).",2020,"Mean change in overall PCS score was +1.0 with semaglutide vs +0.4 with placebo, and +0.5 vs -0.2 for MCS.",['patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6'],"['SF-36v2® questionnaire (comprising physical component summary [PCS] and mental component summary [MCS', 'placebo', 'semaglutide vs placebo']","['overall PCS score', 'MCS', 'health-related quality of life (HRQoL', 'body weight', 'health-related quality of life', 'adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in HbA 1c  , body weight, blood pressure, heart rate and estimated glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3811844'}]",,0.165028,"Mean change in overall PCS score was +1.0 with semaglutide vs +0.4 with placebo, and +0.5 vs -0.2 for MCS.","[{'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Jódar', 'Affiliation': 'Faculty of Medicine, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Michelsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, San Diego, California.'}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Réa', 'Affiliation': 'Department of Clinical Medicine, SEMPR, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sandberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Warren', 'Affiliation': 'Department of Endocrinology, Physicians East, Greenville, North Carolina.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Harring', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Ziegler', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14039']
425,30698839,Alcohol Abstainer Status and Prazosin Treatment in Association with Changes in Posttraumatic Stress Disorder Symptoms in Veterans with Comorbid Alcohol Use Disorder and Posttraumatic Stress Disorder.,"BACKGROUND


The noradrenergic system has been implicated in alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD), with adrenergic agents reducing drinking in individuals with AUD and improving sleep disturbances in individuals with PTSD. In a recent clinical trial, prazosin, an α1-adrenergic antagonist, was not superior to placebo in reducing PTSD symptoms, sleep problems, or alcohol consumption in a comorbid population; however, patients in both treatment conditions improved in all symptom domains over the course of treatment. It remains unknown whether alcohol abstinence is related to changes in PTSD symptoms and medication effects in individuals with this comorbidity.
METHODS


Veterans with comorbid alcohol dependence and PTSD (n = 96) were randomized to prazosin (16 mg) or placebo in a 12-week outpatient, double-blind clinical trial. In this secondary data analysis, we examined main effects of alcohol abstainer status (abstainer vs. nonabstainer), treatment, and their interaction on changes in PTSD symptoms over time using linear mixed models.
RESULTS


There was a main effect of alcohol abstainer status on symptoms of PTSD (p = 0.03), such that nonabstainers had lower total Clinician-Administered PTSD Scale (CAPS) scores than abstainers. There was a significant treatment by alcohol abstainer status interaction (p = 0.01); specifically, among placebo-treated individuals, those who did not abstain from alcohol had lower total CAPS scores compared to alcohol abstainers. Within the prazosin-treated group, abstainers and nonabstainers did not differ on total CAPS scores. Results were similar for the avoidance (p = 0.02), reexperiencing (p = 0.01), and hyperarousal (p = 0.04) subscales, such that placebo-treated nonabstainers had lower CAPS scores overall.
CONCLUSIONS


Overall, prazosin treatment was not significantly related to changes in PTSD symptoms over the course of the 12-week clinical trial in a comorbid population. Interestingly, placebo-treated alcohol nonabstainers had a significant reduction in PTSD symptoms. Whether placebo-treated individuals continued to use alcohol because of ongoing symptoms of PTSD is not known.",2019,"Overall, prazosin treatment was not significantly related to changes in PTSD symptoms over the course of the 12-week clinical trial in a comorbid population.","['Veterans with Comorbid Alcohol Use Disorder and Posttraumatic Stress Disorder', 'Veterans with comorbid alcohol dependence and PTSD', 'individuals with AUD and improving sleep disturbances in individuals with PTSD', 'individuals with this comorbidity']","['Alcohol Abstainer Status and Prazosin', 'placebo', 'prazosin']","['alcohol abstainer status interaction', 'total CAPS scores', 'CAPS scores overall', 'alcohol abstainer status on symptoms of PTSD', 'hyperarousal', 'PTSD symptoms, sleep problems, or alcohol consumption', 'PTSD symptoms', 'total Clinician-Administered PTSD Scale (CAPS) scores']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}]",96.0,0.0197771,"Overall, prazosin treatment was not significantly related to changes in PTSD symptoms over the course of the 12-week clinical trial in a comorbid population.","[{'ForeName': 'Terril L', 'Initials': 'TL', 'LastName': 'Verplaetse', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ralevski', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'McKee', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ismene L', 'Initials': 'IL', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13969']
426,32087380,No Faculty Required: Use of a Health Literacy Low Inference Self-Assessment Measure to Promote Behavior Change.,"OBJECTIVE


To determine if use of a health literacy low-inference, self-assessment measure (LISAM), promoted behavior change as measured by increased use of health literacy communication skills (HLCS).
METHODS


The LISAM is a tool used by educators to self-assess their performances after giving a lecture. The tool is low inference because it self-assesses behaviors that are specific, with little room for subjectivity. Forty-four third-year medical students self-assessed HLCS using a LISAM modified to include health literacy communication skills (LISAM-HLCS).  Self-assessment followed participation in an audio recorded, standardized patient encounter and again after listening to the recording.  Students also created 3 written goals for improvement.  This session was repeated 1 week later.
RESULTS


At Session 2, 71.4% of students met at least 2 of their 3 self-created objectives. The 3 most commonly created objectives were using teach-back, asking more open ended questions, and obtaining patient input into the management plan. Use of the LISAM increased HLCS use at Session 2 versus Session 1 as assessed by both students and study investigators (P < .05).
CONCLUSIONS


Without faculty present, students met and adjusted objectives, catalyzing changes in HLCS. The LISAM-HLCS has the potential to empower students to improve communication skills and to reduce dependence on faculty observations.",2020,"Use of the LISAM increased HLCS use at Session two vs. Session one as assessed by both students and study investigators (p<0.05).
",['Forty-four third-year medical students self-assessed HLCS using a LISAM modified to include health literacy communication skills (LISAM-HLCS'],"['health literacy low-inference, self-assessment measure (LISAM']",['health literacy communication skills (HLCS'],"[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.0128153,"Use of the LISAM increased HLCS use at Session two vs. Session one as assessed by both students and study investigators (p<0.05).
","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex. Electronic address: Aditi.gupta@bcm.edu.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wood', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex; Center for Research, Innovation and Scholarship in Medical Education, Texas Children's Hospital (S Kumar and T Turner), Houston, Tex.""}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex.""}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Turner', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital (A Gupta, M Wood, S Kumar, S Misra, and T Turner), Houston, Tex; Center for Research, Innovation and Scholarship in Medical Education, Texas Children's Hospital (S Kumar and T Turner), Houston, Tex.""}]",Academic pediatrics,['10.1016/j.acap.2020.02.019']
427,31250168,Comparison of analgesic techniques in MRI-guided in-bore prostate biopsy.,"OBJECTIVES


To evaluate different analgesic techniques in MRI-guided in-bore prostate biopsy (IB-GB) regarding the influence on patient procedural experience of pain.
METHODS


Two hundred fifty-two consecutive patients who had received an IB-GB either with intrarectal instillation of 2% lidocaine gel (n = 126, group A) or with periprostatic nerve block (PPNB) with 2% mepivacaine (n = 126, group B) were retrospectively included in this study. Pain scores were measured on a visual analog scale, the operating room time (ORT) was recorded for each biopsy and correlations between the parameters were analysed.
RESULTS


Pain scores for IB-GB were slightly lower in group B compared with group A (2.0 ± 1.9; 2.4 ± 1.7; p = 0.02). In group A, significantly more targeted biopsy cores were acquired (group B: 5.2 ± 1.1; group A: 5.6 ± 0.8; p < 0.01). ORT was comparable and not significantly different in both groups. There was only a weak correlation between pain scores and ORT in group B (r S  = 0.22; p = 0.01), but no correlation between pain scores and the number of biopsy cores or the prostate volume.
CONCLUSIONS


Pain levels are generally low for MRI-guided in-bore biopsy using either PPNB or intrarectal instillation of lidocaine gel. A statistically significant, slightly lower pain score was documented for PPNB and might be preferred when the focus is analgesia. On the other hand, due to the minor difference and easier administration, intrarectal gel instillation seems to be a reasonable practice for standard analgesia for MRI-guided in-bore biopsy.
KEY POINTS


• Pain levels were low for MRI-guided in-bore biopsy using either PPNB or intrarectal instillation of lidocaine gel as analgesic method. • PPNB prior to IB-GB resulted in a slightly lower pain score but required a higher effort. • Intrarectal gel anaesthesia seems to be a reasonable practice for standard analgesia for IB-GB in an outpatient setting.",2019,Pain levels were low for MRI-guided in-bore biopsy using either PPNB or intrarectal instillation of lidocaine gel as analgesic method.,"['patient procedural experience of pain', 'n\u2009=\u2009126, group B', 'MRI-guided in-bore prostate biopsy', 'Two hundred fifty-two consecutive patients who had received an IB-GB either with intrarectal instillation of 2']","['MRI-guided in-bore prostate biopsy (IB-GB', 'periprostatic nerve block (PPNB) with 2% mepivacaine', 'lidocaine gel']","['pain scores and ORT', 'Pain levels', 'pain score', 'pain scores and the number of biopsy cores or the prostate volume', 'Pain scores for IB-GB', 'visual analog scale, the operating room time (ORT', 'Pain scores', 'ORT', 'targeted biopsy cores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",252.0,0.0325948,Pain levels were low for MRI-guided in-bore biopsy using either PPNB or intrarectal instillation of lidocaine gel as analgesic method.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Quentin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arsov', 'Affiliation': 'Department of Urology, University Dusseldorf, Medical Faculty, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ullrich', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Valentin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hiester', 'Affiliation': 'Department of Urology, University Dusseldorf, Medical Faculty, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blondin', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, University Dusseldorf, Medical Faculty, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Antoch', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schimmöller', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Dusseldorf, Medical Faculty, Moorenstr. 5, D-40225, Dusseldorf, Germany. Lars.Schimmoeller@med.uni-duesseldorf.de.'}]",European radiology,['10.1007/s00330-019-06301-w']
428,31119418,Integrated versus separate reading of F-18 FDG-PET/CT and MRI for abdominal malignancies - effect on staging outcomes and diagnostic confidence.,"OBJECTIVE


Abdominal cancer patients increasingly undergo multimodality imaging. This study evaluates effects of integrated reading of PET/CT and abdominal MRI on staging outcomes and diagnostic confidence compared to ""routine"" separate reading.
METHODS


In total, N = 201 patients who underwent abdominal MRI and whole-body F-18 FDG-PET/CT within 14 days were retrospectively analyzed. Original MRI and PET/CT reports were retrieved and reported findings translated into a 5-point confidence score (1 = definitely benign to 5 = definitely malignant) for 7 standardized regions (primary tumor/regional lymph nodes/distant lymph nodes/liver/lung/bone/peritoneum) per patient. Two-reader teams (radiologist + nuclear medicine physician) then performed integrated reading of the images using the same scoring system.
RESULTS


Integrated reading led to discrepant findings in 59 of 201 (29%) of patients, with potential clinical impact in 25 of 201 (12%). Equivocal scores decreased from 5.7% (PET/CT) and 5.4% (MRI) to 3.2% (p = 0.05 and p = 0.14). Compared to the original PET/CT reports, integrated reading led to increased diagnostic confidence in 8.9% versus decreased confidence in 6.6% (p = 0.26). Compared with the original MRI reports, an increase in confidence occurred in 9.6% versus a decrease in 6.9% (p = 0.18). The effect on diagnostic confidence was most pronounced in lymph nodes (p = 0.08 vs. MRI), cervical cancer (p = 0.03 vs. MRI), and recurrent disease staging (p = 0.06 vs. PET/CT).
CONCLUSIONS


Integrated PET/CT+MRI reading alters staging outcomes in a substantial proportion of cases with potential clinical impact in ± 1 out of 9 patients. It can also have a small positive effect on diagnostic confidence, particularly in lymph nodes and cervical cancer, and in post-treatment settings. These findings support further collaboration between radiology and nuclear medicine disciplines.
KEY POINTS


• Increasing numbers of patients undergo multimodality imaging consisting of both MRI and PET/CT for staging of abdominal malignancies. • Integrated reading of FDG-PET/CT and abdominal MR images by a team, consisting of a radiologist and a nuclear medicine physician, can alter staging outcomes compared to separate reporting of the exams in a substantial proportion of cases and with potential clinical impact in ± 1 out of 9 patients. • Integrated PET/CT+MRI reading can have a small positive effect on diagnostic confidence.",2019,"The effect on diagnostic confidence was most pronounced in lymph nodes (p = 0.08 vs. MRI), cervical cancer (p = 0.03 vs. MRI), and recurrent disease staging (p = 0.06 vs. PET/CT).
",['Abdominal cancer patients'],"['MRI and PET/CT', 'integrated reading of PET/CT and abdominal MRI']","['diagnostic confidence', 'Equivocal scores', 'cervical cancer', 'recurrent disease staging', 'confidence']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0332241', 'cui_str': 'Equivocal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}]",201.0,0.0647335,"The effect on diagnostic confidence was most pronounced in lymph nodes (p = 0.08 vs. MRI), cervical cancer (p = 0.03 vs. MRI), and recurrent disease staging (p = 0.06 vs. PET/CT).
","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, The Netherlands Cancer Institute, POB 90203, 1006 BE, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter V', 'Initials': 'WV', 'LastName': 'Vogel', 'Affiliation': 'Department of Nuclear Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Lahaye', 'Affiliation': 'Department of Radiology, The Netherlands Cancer Institute, POB 90203, 1006 BE, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Department of Radiology, The Netherlands Cancer Institute, POB 90203, 1006 BE, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten L', 'Initials': 'ML', 'LastName': 'Donswijk', 'Affiliation': 'Department of Nuclear Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vegt', 'Affiliation': 'Department of Nuclear Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Kusters', 'Affiliation': 'Department of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Zijlmans', 'Affiliation': 'Department of Gynecologic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jóźwiak', 'Affiliation': 'Department of Epidemiology and Biostatistics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Roberti', 'Affiliation': 'Department of Epidemiology and Biostatistics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Regina G H', 'Initials': 'RGH', 'LastName': 'Beets-Tan', 'Affiliation': 'Department of Radiology, The Netherlands Cancer Institute, POB 90203, 1006 BE, Amsterdam, The Netherlands.'}, {'ForeName': 'Doenja M J', 'Initials': 'DMJ', 'LastName': 'Lambregts', 'Affiliation': 'Department of Radiology, The Netherlands Cancer Institute, POB 90203, 1006 BE, Amsterdam, The Netherlands. d.lambregts@nki.nl.'}]",European radiology,['10.1007/s00330-019-06253-1']
429,30895579,Utilizing Video versus Direct Laryngoscopy to Intubate Simulated Newborns while Contained within the Incubator: A Randomized Crossover Study.,"OBJECTIVE


The use of video laryngoscopy for intubating neonates in ergonomically challenging settings has not been studied well. We aimed to assess the usefulness of video laryngoscopy for experienced neonatologists to intubate neonatal manikins in incubators via side hand ports or head window.
STUDY DESIGN


In this randomized crossover trial at three neonatal intensive care units in Japan, 27 neonatologists were randomized into two groups, namely, those intubating neonatal simulators using video laryngoscopy and then using direct laryngoscopy, or vice versa. The intubations were performed via hand ports or head window without opening top and side walls in incubators in two manikin positions (rotated 90° or unrotated). Glottis visualization (0-100%), success rate, intubation time, and ease of laryngoscopy (from 1 [very difficult] to 10 [very easy]) were compared between video laryngoscopy and direct laryngoscopy. Generalized linear models were used for the analyses.
RESULTS


This study assessed 108 intubations performed by 27 neonatologists. The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
CONCLUSION


Video laryngoscopy is useful for experienced neonatologists for intubating neonatal manikins in incubators without opening the top or side walls.",2020,"The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
","['108 intubations performed by 27 neonatologists', 'three neonatal intensive care units in Japan, 27 neonatologists']","['intubating neonatal simulators using video laryngoscopy and then using direct laryngoscopy, or vice versa', 'video laryngoscopy', 'intubations were performed via hand ports or head window without opening top and side walls in incubators in two manikin positions (rotated 90° or unrotated', 'Utilizing Video versus Direct Laryngoscopy', 'Video laryngoscopy']","['Glottis visualization', 'intubation time', 'success rate, intubation time, and ease of laryngoscopy', 'easiness scores of laryngoscopy', 'glottis visualization']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0334898', 'cui_str': 'Neonatologists'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}]","[{'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",108.0,0.0560904,"The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Humiko', 'Initials': 'H', 'LastName': 'Miyahara', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Hosoi', 'Affiliation': 'Department of Pediatrics, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mazumi', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Division of Pediatrics and Perinatology, Tottori University Faculty of Medicine, Yonago, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Morisaki', 'Affiliation': 'Department of Social Medicine, Research Institute, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Isayama', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}]",American journal of perinatology,['10.1055/s-0039-1683957']
430,32223318,Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial.,"BACKGROUND


Patients with established coronary artery disease or peripheral artery disease often have diabetes mellitus. These patients are at high risk of future vascular events.
METHODS


In a prespecified analysis of the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies), we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes mellitus versus without diabetes mellitus in preventing major vascular events. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included all-cause mortality and all major vascular events (cardiovascular death, myocardial infarction, stroke, or major adverse limb events, including amputation). The primary safety end point was a modification of the International Society on Thrombosis and Haemostasis criteria for major bleeding.
RESULTS


There were 10 341 patients with diabetes mellitus and 17 054 without diabetes mellitus in the overall trial. A consistent and similar relative risk reduction was seen for benefit of rivaroxaban plus aspirin (n=9152) versus placebo plus aspirin (n=9126) in patients both with (n=6922) and without (n=11 356) diabetes mellitus for the primary efficacy end point (hazard ratio, 0.74,  P =0.002; and hazard ratio, 0.77,  P =0.005, respectively,  P interaction =0.77) and all-cause mortality (hazard ratio, 0.81,  P =0.05; and hazard ratio, 0.84,  P =0.09, respectively;  P interaction =0.82). However, although the absolute risk reductions appeared numerically larger in patients with versus without diabetes mellitus, both subgroups derived similar benefit (2.3% versus 1.4% for the primary efficacy end point at 3 years, Gail-Simon qualitative  P interaction <0.0001; 1.9% versus 0.6% for all-cause mortality,  P interaction =0.02; 2.7% versus 1.7% for major vascular events,  P interaction <0.0001). Because the bleeding hazards were similar among patients with and without diabetes mellitus, the prespecified net benefit for rivaroxaban appeared particularly favorable in the patients with diabetes mellitus (2.7% versus 1.0%; Gail-Simon qualitative  P interaction =0.001).
CONCLUSIONS


In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral end points in patients with and without diabetes mellitus. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes mellitus, including a 3-fold greater reduction in all-cause mortality. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.",2020,"There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p interaction =0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p interaction =0.82).","['Diabetes and Cardiovascular Disease', '10,341 patients with diabetes and 17,054 without diabetes in the overall trial', 'patients with diabetes versus without diabetes in preventing major vascular events', 'Patients with established coronary artery disease (CAD) or peripheral artery disease (PAD) often have diabetes mellitus', 'patients with and without diabetes']","['aspirin', 'rivaroxaban plus aspirin', 'aspirin plus rivaroxaban', 'placebo plus aspirin', 'rivaroxaban']","['absolute risk reductions', 'coronary, cerebrovascular, and peripheral endpoints', 'composite of cardiovascular death, myocardial infarction (MI), or stroke', 'cause mortality', 'bleeding hazards', 'cause mortality and all major vascular events (cardiovascular death, MI, stroke, or major adverse limb events including amputation', 'modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding']","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",10341.0,0.29241,"There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p interaction =0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p interaction =0.82).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA (D.L.B.).""}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Ontario, Canada (S.V.).""}, {'ForeName': 'Kelley R H', 'Initials': 'KRH', 'LastName': 'Branch', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B., J.P.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B., J.P.).'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shestakovska', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimský', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (P.W.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil (A.A.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina (R.D.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa (B.S.L.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ryden', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (L.R.).'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046448']
431,30919396,Parental Perceptions and Behaviors Regarding Child Weight Status among Toddlers Born Preterm.,"OBJECTIVE


Childhood obesity is a significant determinant of adult obesity. Among children born preterm, rapid ""catch-up growth"" in infancy increases the risk of later obesity. Parental perceptions of their child's weight status may compound the child's biologically heightened risk of obesity.
STUDY DESIGN


We performed a secondary analysis of data on parental perceptions of child weight status from a randomized controlled trial (2012-2017,  n  = 331 toddlers born preterm). We used the Child Feeding Questionnaire (CFQ) to measure parental child feeding behaviors and beliefs. We calculated the prevalence of incorrect weight estimation, and used  t -tests and chi-square tests to compare sample characteristics by correct versus incorrect weight estimation. We calculated odds ratios (ORs) for factors associated with parental underestimation of child weight status.
RESULTS


Most (90%) children were of normal weight, whereas 3% were underweight and 7% were overweight. A majority (75%) of parents correctly estimated their child's weight status. Incorrect weight estimation was only associated with child's actual weight. Parents of overweight children were more likely to underestimate their child's weight status than parents of normal weight children (OR: 2.23, 95% confidence interval: 2.00-2.49). Mean CFQ scores differed by the child's actual weight status but not by the child's estimated weight status.
CONCLUSION


Among these toddlers born preterm, significantly higher proportions of parents with underweight and overweight children incorrectly estimated their child's weight status relative to parents of normal weight children. Our findings suggest that weight underestimation could be a problem in this population, although it was not associated with changes in feeding practices.",2020,"Mean CFQ scores differed by the child's actual weight status but not by the child's estimated weight status.
","['toddlers', 'Toddlers Born Preterm', 'Most (90%) children were of normal weight, whereas 3% were underweight and 7% were overweight', 'children born preterm', 'parental perceptions of child weight status from a randomized controlled trial (2012-2017,  n \u2009=\u2009331 toddlers born preterm', 'Parents of overweight children']",['Child Feeding Questionnaire (CFQ'],"['Parental Perceptions and Behaviors Regarding Child Weight Status', 'Mean CFQ scores', 'Incorrect weight estimation']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0228212,"Mean CFQ scores differed by the child's actual weight status but not by the child's estimated weight status.
","[{'ForeName': 'Jessica Londeree', 'Initials': 'JL', 'LastName': 'Saleska', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Sheppard', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}]",American journal of perinatology,['10.1055/s-0039-1683959']
432,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background


Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective


To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design


Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting


57 Parkinson Study Group sites in North America.
Participants


Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention


5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements


The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results


336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation


The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source


National Institute of Neurological Disorders and Stroke.",2020,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
433,32222796,Control of postpartum hemorrhage in women with placenta accreta spectrum using prophylactic balloon occlusion combined with Pituitrin intra-arterial infusion.,"OBJECTIVES


The aim of this study is to evaluate the efficacy of prophylactic internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion in the control of postpartum hemorrhage in women with placenta accreta spectrum (PAS).
METHODS


This is a prospective and non-randomized controlled study. The participants were assigned into three groups: without balloon catheterization (non-BC) group, balloon catheterization (BC) group, and Pituitrin combined with balloon catheterization (PBC) group. The primary outcomes were estimated blood loss (EBL) and the units of transfused packed red blood cells (PRBC). The secondary outcome was the incidence of hysterectomy.
RESULTS


A total of 100 participants were recruited between August 2013 and November 2018 and assigned into the respective groups as follows: 27 in the non-BC group, 22 in the BC group, and 51 in the PBC group. No statistical differences were found in demographic characteristics among the three groups. There was a trend of lower EBL, PRBC, and hysterectomy rate in the BC group than those in the non-BC group, while all values showed no significant differences (all p > 0.05). Patients in the PBC group had significantly lower EBL, PRBC, and hysterectomy rate compared with those in the non-BC group (all p < 0.05). Linear regression analysis revealed that the PBC (vs. others) was negatively correlated with EBL and the non-BC (vs. others) independently predicted more EBL.
CONCLUSIONS


Balloon occlusion combined with Pituitrin infusion is an effective treatment method which significantly reduced EBL, PRBC, and hysterectomy rate in patients with PAS.
KEY POINTS


• Internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion can significantly decrease EBL, PRBC, and hysterectomy rate during cesarean section in patients with PAS. • Cesarean section without balloon occlusion and placenta accreta depth are two independent risk factors for EBL in patients with PAS.",2020,"Internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion can significantly decrease EBL, PRBC, and hysterectomy rate during cesarean section in patients with PAS.","['women with placenta accreta spectrum (PAS', 'patients with PAS', 'women with placenta accreta spectrum using', 'A total of 100 participants were recruited between August 2013 and November 2018 and assigned into the respective groups as follows: 27 in the non-BC group, 22 in the BC group, and 51 in the PBC group']","['prophylactic internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion', 'without balloon catheterization (non-BC) group, balloon catheterization (BC) group, and Pituitrin combined with balloon catheterization (PBC', 'Pituitrin infusion', 'Cesarean section without balloon occlusion and placenta accreta depth', 'Internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion', 'prophylactic balloon occlusion combined with Pituitrin intra-arterial infusion']","['lower EBL, PRBC, and hysterectomy rate', 'demographic characteristics', 'incidence of hysterectomy', 'EBL, PRBC, and hysterectomy rate', 'estimated blood loss (EBL) and the units of transfused packed red blood cells (PRBC', 'postpartum hemorrhage']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032044', 'cui_str': 'Placenta Accreta'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032023', 'cui_str': 'Pituitrin'}, {'cui': 'C0021439', 'cui_str': 'Infusions, Intraarterial'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0032044', 'cui_str': 'Placenta Accreta'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}]",100.0,0.0858371,"Internal iliac artery balloon occlusion combined with Pituitrin intra-arterial infusion can significantly decrease EBL, PRBC, and hysterectomy rate during cesarean section in patients with PAS.","[{'ForeName': 'Mengjun', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Department of Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, No. 160, Pujian Road, Pudong New District, Shanghai, 200127, China.'}, {'ForeName': 'Guangxin', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': 'Department of Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, No. 160, Pujian Road, Pudong New District, Shanghai, 200127, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics & Gynecology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics & Gynecology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127, China.'}, {'ForeName': 'Yunyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics & Gynecology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics & Gynecology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127, China.'}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, No. 160, Pujian Road, Pudong New District, Shanghai, 200127, China. zhangxuebinwqy@163.com.'}]",European radiology,['10.1007/s00330-020-06813-w']
434,32224306,"Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial.","BACKGROUND


Few options exist for treatment of patients with small-cell lung cancer (SCLC) after failure of first-line therapy. Lurbinectedin is a selective inhibitor of oncogenic transcription. In this phase 2 study, we evaluated the acti and safety of lurbinectedin in patients with SCLC after failure of platinum-based chemotherapy.
METHODS


In this single-arm, open-label, phase 2 basket trial, we recruited patients from 26 hospitals in six European countries and the USA. Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors (RECIST) version 1.1, absence of brain metastasis, adequate organ function, and pre-treated with only one previous chemotherapy-containing line of treatment (minimum 3 weeks before study initiation) were eligible. Treatment consisted of 3·2 mg/m 2  lurbinectedin administered as a 1-h intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. The primary outcome was the proportion of patients with an overall response (complete or partial response) as assessed by the investigators according to RECIST 1.1. All treated patients were analysed for activity and safety. This study is ongoing and is registered with ClinicalTrials.gov, NCT02454972.
FINDINGS


Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with lurbinectedin. Median follow-up was 17·1 months (IQR 6·5-25·3). Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2). The most common grade 3-4 adverse events (irrespective of causality) were haematological abnormalities-namely, anaemia (in nine [9%] patients), leucopenia (30 [29%]), neutropenia (48 [46%]), and thrombocytopenia (seven [7%]). Serious treatment-related adverse events occurred in 11 (10%) patients, of which neutropenia and febrile neutropenia were the most common (five [5%] patients for each). No treatment-related deaths were reported.
INTERPRETATION


Lurbinectedin was active as second-line therapy for SCLC in terms of overall response and had an acceptable and manageable safety profile. Lurbinectedin could represent a potential new treatment for patients with SCLC, who have few options especially in the event of a relapse, and is being investigated in combination with doxorubicin as second-line therapy in a randomised phase 3 trial.
FUNDING


Pharma Mar.",2020,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"['Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with', 'recruited patients from 26 hospitals in six European countries and the USA', 'patients with SCLC', 'Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors', 'patients with SCLC after failure of platinum-based chemotherapy', 'patients with small-cell lung cancer (SCLC) after failure of first-line therapy', 'patients with small-cell lung cancer']","['doxorubicin', 'Lurbinectedin', '3·2 mg/m 2  lurbinectedin', 'lurbinectedin']","['leucopenia', 'Overall response', 'proportion of patients with an overall response (complete or partial response', 'activity and safety', 'adverse events', 'neutropenia', 'haematological abnormalities-namely, anaemia', 'neutropenia and febrile neutropenia', 'thrombocytopenia']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3898565'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",105.0,0.123332,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Trigo', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain. Electronic address: jmtrigo@seom.org.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Gustave Roussy Cancer Campus, Villejuif, France; Paris Sud University, Orsay, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'START Madrid-Fundación Jiménez Díaz, Hospital Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María Angeles', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': 'Organización Sanitaria Integrada Bilbao Basurto, Bilbao, Spain.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Kahatt', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zeaiter', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Boni', 'Affiliation': 'START Madrid-Centro Integral Oncológico Clara Campal, Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arrondeau', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Olmedo', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Wannesson', 'Affiliation': 'Ospedale San Giovanni, Bellinzona, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valdivia', 'Affiliation': 'Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Reina Sofía, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': 'Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sarantopoulos', 'Affiliation': 'Institute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio, MD Anderson Cancer Center, San Antonio, TX, USA.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, CA, USA.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Mosquera-Martinez', 'Affiliation': 'Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': ""D'Arcangelo"", 'Affiliation': 'Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Istituto Clinico Humanitas, Rossano, Italy.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Villalobos', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30068-1']
435,31282921,Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia: A Stepped-Wedge Randomized Clinical Trial.,"Importance


Community-acquired pneumonia remains a leading cause of hospitalization, mortality, and health care costs worldwide. Randomized clinical trials support the use of adjunctive corticosteroids, early progressive mobilization, antibiotic switching rules, and dietary interventions in improving outcomes. However, it is uncertain whether implementing these interventions will translate into effectiveness under routine health care conditions.
Objective


To evaluate the effectiveness of a bundle of evidence-supported treatments under conditions of routine care in a representative population hospitalized for community-acquired pneumonia.
Design, Setting, and Participants


A double-blind, stepped-wedge, cluster-randomized clinical trial with 90-day follow-up was conducted between August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia. The primary analysis and preparation of results took place between May 14 and November 25, 2018.
Interventions


Treating clinical teams were advised to prescribe prednisolone acetate, 50 mg/d, for 7 days (in the absence of any contraindication) and de-escalate from parenteral to oral antibiotics according to standardized criteria. Algorithm-guided early mobilization and malnutrition screening and treatment were also implemented.
Main Outcomes and Measures


Hospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia).
Results


A total of 917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group. An unadjusted geometric mean ratio of 0.95 (95% CI, 0.78-1.16) was observed for the difference in length of stay (days) between the intervention and control groups. Similarly, no significant differences were observed for the secondary outcomes of mortality and readmission, and the results remained unchanged after further adjustment for sex and age. The study reported higher proportions of gastrointestinal bleeding in the intervention group (9 [2.2%]) compared with the controls (3 [0.7%]), with an unadjusted estimated difference in mean proportions of 0.008 (95% CI, 0.005-0.010).
Conclusions and Relevance


This bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding. Efficacy of individual interventions demonstrated in clinical trials may not necessarily translate into effectiveness when implemented in combination and may even result in net harm.
Trial Registration


ClinicalTrials.gov identifier: NCT02835040.",2019,This bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding.,"['917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group', 'representative population hospitalized for community-acquired pneumonia', 'Hospitalized Patients With Community-Acquired Pneumonia', 'August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia']","['Bundled Intervention Including Adjunctive Corticosteroids', 'individual interventions', 'prednisolone acetate']","['length of stay', 'gastrointestinal bleeding', 'mortality and readmission', 'Measures\n\n\nHospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",917.0,0.130453,This bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding.,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lloyd', 'Affiliation': 'Department of Physiotherapy, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Karahalios', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Janus', 'Affiliation': 'Department of Medicine, Western Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Skinner', 'Affiliation': 'Department of Physiotherapy, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anurika', 'Initials': 'A', 'LastName': 'De Silva', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lowe', 'Affiliation': 'Department of Physiotherapy, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Shackell', 'Affiliation': 'Department of Physiotherapy, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Soe', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'General Internal Medicine Unit, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Desmond', 'Affiliation': 'General Internal Medicine Unit, Western Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Harin', 'Initials': 'H', 'LastName': 'Karunajeewa', 'Affiliation': 'Department of Medicine, Western Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.1438']
436,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
437,31812510,"Effects of Belapectin, an Inhibitor of Galectin-3, in Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension.","BACKGROUND & AIMS


Increased levels of galectin 3 have been associated with nonalcoholic steatohepatitis (NASH) and contribute to toxin-induced liver fibrosis in mice. GR-MD-02 (belapectin) is an inhibitor of galectin 3 that reduces liver fibrosis and portal hypertension in rats and was safe and well tolerated in phase 1 studies. We performed a phase 2b, randomized trial of the safety and efficacy of GR-MD-02 in patients with NASH, cirrhosis, and portal hypertension.
METHODS


Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient [HVPG] ≥ 6 mm Hg) from 36 centers were randomly assigned, in a double-blind manner, to groups that received biweekly infusions of belapectin 2 mg/kg (n = 54), 8 mg/kg (n = 54), or placebo (n = 54) for 52 weeks. The primary endpoint was change in HVPG (Δ HVPG) at the end of the 52-week period compared with baseline. Secondary endpoints included changes in liver histology and development of liver-related outcomes.
RESULTS


We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0). Belapectin had no significant effect on fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes did not differ significantly among groups. In an analysis of a subgroup of patients without esophageal varices at baseline (n = 81), 2 mg/kg belapectin was associated with a reduction in HVPG at 52 weeks compared with baseline (P = .02) and reduced development of new varices (P = .03). Belapectin (2 mg/kg) was well tolerated and produced no safety signals.
CONCLUSIONS


In a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, 1 year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis compared with placebo. However, in a subgroup analysis of patients without esophageal varices, 2 mg/kg belapectin did reduce HVPG and development of varices. ClinicalTrials.gov number: NCT02462967.",2020,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","['Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension', '6 mm Hg) from 36 centers', 'Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient', '162 patients with NASH, cirrhosis, and portal hypertension', 'patients with NASH, cirrhosis, and portal hypertension']","['HVPG', 'placebo', 'belapectin', 'Belapectin', 'GR-MD-02 (belapectin', 'GR-MD-02']","['liver fibrosis and portal hypertension', 'HVPG or fibrosis', 'ΔHVPG', 'esophageal varices', 'HVPG and development of varices', 'HVPG', 'fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes', 'changes in liver histology and development of liver-related outcomes', 'change in HVPG (-28', 'reduced development of new varices', 'tolerated and produced no safety signals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",162.0,0.533553,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","[{'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: nchalasa@iu.edu.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Garcia-Tsao', 'Affiliation': 'Yale University, New Haven, Colorado.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, San Antonio, Texas.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedar Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Maxmillan', 'Initials': 'M', 'LastName': 'Pyko', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Richmond and Newport News, Virginia.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Allgood', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Shlevin', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Horton', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Zomer', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Irish', 'Affiliation': 'East Carolina University, Greenville, South Carolina.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Research Institute, San Antonio, Texas.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Traber', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2019.11.296']
438,30866027,Effect of Treatment of Mild Gestational Diabetes on Long-Term Maternal Outcomes.,"OBJECTIVE


The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes.
STUDY DESIGN


This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit.
RESULTS


Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
CONCLUSION


Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.",2020,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","['women with mild gestational diabetes mellitus (GDM', 'Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy', 'Women were enrolled between 5 and 10 years after their index pregnancy', 'women who participated in a randomized controlled treatment trial for mild GDM']",['nutritional counseling and medical therapy (treated'],"['metabolic syndrome', 'homeostasis model assessment for insulin resistance', 'BMI', 'Frequency of diabetes', 'Subsequent diabetes, metabolic syndrome, obesity, and adiposity', 'maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes', 'fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}]",457.0,0.0436331,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Van Dorsten', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1681058']
439,32160019,"Effects of intraduodenal coadministration of lauric acid and leucine on gut motility, plasma cholecystokinin, and energy intake in healthy men.","The fatty acid, lauric acid (C12), and the amino acid, leucine (Leu) stimulate gut hormones, including CCK, associated with suppression of energy intake. In our recent study, intraduodenal infusion of a combination of C12 and l-tryptophan, at loads that individually did not affect energy intake, reduced energy intake substantially, associated with much greater stimulation of CCK. We have now investigated whether combined administration of C12 and Leu would enhance the intake-suppressant effects of each nutrient, when given at loads that each suppress energy intake individually. Sixteen healthy, lean males (age: 23 ± 2 yr) received, in randomized, double-blind fashion, 90-min intraduodenal infusions of control (saline), C12 (0.4 kcal/min), Leu (0.45 kcal/min), or C12+Leu (0.85 kcal/min). Antropyloroduodenal pressures were measured continuously and plasma CCK at 15-min intervals, and energy intake from a standardized buffet-meal, consumed immediately postinfusion, was quantified. All nutrient infusions stimulated plasma CCK compared with control ( P  < 0.05). Moreover, C12 and C12+Leu stimulated CCK compared with Leu ( P  < 0.05) (mean concentration, pmol/L; control: 2.3 ± 0.3, C12: 3.8 ± 0.3, Leu: 2.7 ± 0.3, and C12+Leu: 4.0 ± 0.4). C12+Leu, but not C12 or Leu, stimulated pyloric pressures ( P  < 0.05). C12+Leu and C12 reduced energy intake ( P  < 0.05), and there was a trend for Leu to reduce ( P  = 0.06) energy intake compared with control, with no differences between the three nutrient treatments (kcal; control: 1398 ± 84, C12: 1226 ± 80, Leu: 1260 ± 92, and C12+Leu: 1208 ± 83). In conclusion, combination of C12 and Leu, at the loads given, did not reduce energy intake beyond their individual effects, possibly because maximal effects had been evoked.",2020,"C12+Leu, but not C12 or Leu, stimulated pyloric pressures (P<0.05).","['16 healthy, lean males (age: 23±2 years', 'healthy men']","['intraduodenal co-administration of lauric acid and leucine', '90-min intraduodenal infusions of control (saline), C12 (0.4 kcal/min), Leu (0.45 kcal/min) or C12+Leu', 'C12 and Leu', 'C12 and L-tryptophan']","['energy intake', 'gut motility, plasma cholecystokinin and energy intake', 'Antropyloroduodenal pressures']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023139', 'cui_str': 'lauric acid'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008328', 'cui_str': 'pancreozymin (cholecystokinin)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",16.0,0.136199,"C12+Leu, but not C12 or Leu, stimulated pyloric pressures (P<0.05).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'McVeay', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Steinert', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sina S', 'Initials': 'SS', 'LastName': 'Ullrich', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00352.2019']
440,32167484,Surgical blood loss during holmium laser enucleation of the prostate (HoLEP) is not affected by short-term pretreatment with dutasteride: a double-blind placebo-controlled trial on prostate vascularity.,Five α-reductase inhibitors (5ARIs) are able to reduce prostate volume and are a useful treatment for reducing perioperative bleeding during prostate surgery. Holmium laser enucleation of the prostate (HoLEP) is an effective surgical technique for the definitive cure of benign prostate enlargement.We investigated whether pretreatment with dutasteride before HoLEP could reduce intraoperative bleeding. A total of 402 patients were included in this double-blind placebo-controlled trial to receive daily 0.5 mg of dutasteride or placebo over 8 weeks before HoLEP. Vascular endothelial growth factor (VEGF) and microvascular density (MVD) were evaluated. Analysis was also stratified according to prostate volume (<70 mL vs ≥70 mL).Hemoglobin and hematocrit values before and after surgery were not statistically different between the two groups. MVD and VEGF index in smaller prostates were 23.35±1.96 and 4.06±0.76 in the treatment group and 19.04±0.96 and 2.55±0.55 in placebo (p<0.05); in patients with larger prostates MVD and VEGF were 26.83±2.812 and 8.54±1.18 in the treatment group and 20.76±0.79 and 3.21±0.54 in placebo (p<0.05).Vascularization of the prostate was affected by 5ARIs therapy. HoLEP is less burdened in perioperative bleeding and for this reason we did not find any difference in hemoglobin/hematocrit values pre- and post- surgery.,2020,HoLEP is less burdened in perioperative bleeding and for this reason we did not find any difference in hemoglobin/hematocrit values pre- and post- surgery.,['A total of 402 patients'],"['HoLEP', 'placebo', 'dutasteride before HoLEP', 'dutasteride or placebo', 'dutasteride', 'Holmium laser enucleation of the prostate (HoLEP', 'holmium laser enucleation of the prostate (HoLEP', 'Five α-reductase inhibitors (5ARIs']","['Vascular endothelial growth factor (VEGF) and microvascular density (MVD', 'Surgical blood loss', 'MVD and VEGF index', 'intraoperative bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",402.0,0.531532,HoLEP is less burdened in perioperative bleeding and for this reason we did not find any difference in hemoglobin/hematocrit values pre- and post- surgery.,"[{'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Busetto', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Del Giudice', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Romagnoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Del Rosso', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Giampaoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corsi', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Palmer', 'Affiliation': 'Department of Internal Medicine and Geriatrics, University Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'Department of Urology, Istituto Europeo di Oncologia (IEO), Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lucarelli', 'Affiliation': 'Department of Emergency and Organ Transplantation, Urology, Andrology and Kidney Transplantation Unit, University of Bari, Bari, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Terracciano', 'Affiliation': 'Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Ottavio', 'Initials': 'O', 'LastName': 'De Cobelli', 'Affiliation': 'Department of Urology, Istituto Europeo di Oncologia (IEO), Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sciarra', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'De Berardinis', 'Affiliation': 'Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Porreca', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.'}]",Aging,['10.18632/aging.102883']
441,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
442,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
443,32209721,"Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials.","BACKGROUND


The interleukin-12/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&2. We further evaluated ustekinumab's effect on spondylitis-related endpoints in PSUMMIT-1&2 tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS.
METHODS


Patients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0 mg/L) despite conventional (PSUMMIT-1&2) and/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45 mg, 90 mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24.
RESULTS


The pooled PSUMMIT-1&2, TNFi-naïve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen ( HLA)-B27  results) presented with moderate-to-severe spondylitis-related symptoms (mean BASDAI-neck/back/hip pain-6.51, mBASDAI-6.54, BASDAI-6.51, ASDAS-3.81). Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59). Improvements in neck/back/hip pain and fatigue appeared numerically greater in  HLA-B27 +  than  HLA-B27  -    patients; those for other domains were generally consistent. Greater proportions of ustekinumab versus placebo-treated patients achieved ASDAS clinically important improvement at Week 24 (decrease ≥ 1.1; 49.6% vs 12.7%; nominal p<0.05).
CONCLUSIONS


Improvements in BASDAI neck/back/hip pain and mBASDAI among ustekinumab-treated, TNFi-naïve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck/back/hip pain in  HLA-B27 +  than  HLA-B27  -    patients, noted in the context of similar overall mBASDAI improvements between the subgroups, suggest ustekinumab may improve disease activity in TNFi-naïve PsA patients likely to exhibit axial disease.
CLINICAL TRIAL REGISTRATION NUMBERS


PSUMMIT 1, NCT01009086; PSUMMIT 2, NCT01077362.",2020,Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59).,"['Patients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0\u2009mg/L) despite conventional (PSUMMIT-1&2) and/or prior', 'tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS', 'TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis']","['ustekinumab', 'interleukin-12/23p40-subunit-inhibitor ustekinumab', 'placebo', 'TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45\u2009mg, 90\u2009mg or placebo']","['Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses', 'neck/back/hip pain and fatigue', 'neck/back/hip pain', 'hip pain', 'disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0150141'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0989843,Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (-1.99 vs -0.18) and mBASDAI (-2.09 vs -0.59).,"[{'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK p.helliwell@leeds.ac.uk.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Chetan S', 'Initials': 'CS', 'LastName': 'Karyekar', 'Affiliation': 'Janssen Global Services LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': 'Janssen Research & Development LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco School of Medicine, San Francisco, California, USA.'}]",RMD open,['10.1136/rmdopen-2019-001149']
444,32219761,Randomized Study Design to Test Effects of Vitamin D and Omega-3 Fatty Acid Supplementation as Adjuvant Therapy in Colorectal Cancer Patients.,"This study examines the effects of vitamin D and omega-3 fatty acid co-supplementation on inflammation and nutritional status in colorectal cancer patients. Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks. As outcomes, we measure height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin, before and after the intervention. The presented results show that vitamin D 3  plus omega-3 fatty acid co-supplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.",2020,"Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks.","['Colorectal Cancer Patients', 'colorectal cancer patients']","['vitamin D and omega-3 fatty acid co-supplementation', 'Vitamin D and Omega-3 Fatty Acid Supplementation', 'omega-3 fatty acids capsules daily for 8\xa0weeks', 'vitamin D 3  plus omega-3 fatty acid co-supplementation', 'placebos; (2) omega-3 fatty acid arm, receiving two 330\xa0mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000\xa0IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation']","['height; weight; fat-free mass (FFM); serum levels of 25(OH)D, TNF-α, and IL-6; C-CRP; and albumin', 'inflammation and nutritional status']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",,0.0537116,"Patients were randomly assigned into four groups: (1) controls, receiving placebos; (2) omega-3 fatty acid arm, receiving two 330 mg omega-3 fatty acid capsules daily and placebo (for vitamin D 3 ) weekly; (3) vitamin D arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two placebos (for omega-3 fatty acids) daily; and (4) co-supplementation arm, receiving a 50,000 IU vitamin D 3  soft gel weekly and two 330 mg omega-3 fatty acids capsules daily for 8 weeks.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. vafa.m@iums.ac.ir.'}]","Methods in molecular biology (Clifton, N.J.)",['10.1007/978-1-0716-0471-7_24']
445,32219762,"Effect of Vitamin D Supplementation on Muscle Strength, Muscle Function, and Body Composition in Vitamin D-Deficient Middle-Aged Women.","Sarcopenia is the loss of muscle strength and muscle mass with aging and is one of the major risk factors for metabolic diseases. Cross-sectional studies have shown that vitamin D is associated with sarcopenia in both men and women. We investigated the effect of vitamin D supplementation over 12 weeks on muscle strength, muscle function, and body composition in middle-aged women in randomized double-blind placebo-controlled trial format. This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups. In addition, handgrip strength was improved, and the timed get up and go (TGUG) test and body fat content were decreased. This chapter presents a protocol for trial setup involving measurement of vitamin D levels, handgrip strength, the TGUT test, and body composition as readouts.",2020,This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups.,"['middle-aged women', 'Vitamin D-Deficient Middle-Aged Women', 'men and women']","['vitamin D supplementation', 'vitamin D', 'Vitamin D Supplementation', 'placebo']","['vitamin D levels, handgrip strength, the TGUT test, and body composition', 'Muscle Strength, Muscle Function, and Body Composition', 'muscle strength, muscle function, and body composition', 'handgrip strength', 'timed get up and go (TGUG) test and body fat content', 'serum 25-hydroxyvitamin D levels']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1303170', 'cui_str': 'Get up and go test'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.293758,This revealed a significant difference in serum 25-hydroxyvitamin D levels between the intervention and placebo groups.,"[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. vafa.m@iums.ac.ir.'}]","Methods in molecular biology (Clifton, N.J.)",['10.1007/978-1-0716-0471-7_25']
446,32219502,Correction to: Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer patients.,The original version of this article unfortunately contained a mistake.,2020,The original version of this article unfortunately contained a mistake.,['ovarian cancer patients'],['carboplatin/paclitaxel plus oregovomab'],[],"[{'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0664207', 'cui_str': 'oregovomab'}]",[],,0.0174148,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Battaglia', 'Affiliation': 'Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, L.go F.Vito 1, 00168, Rome, Italy. alessandra.battaglia@unicatt.it.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Buzzonetti', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fossati', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Istituto di Clinica Ostetrica e Ginecologica, Università Cattolica del Sacro Cuore, L.go F.Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fattorossi', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Madi R', 'Initials': 'MR', 'LastName': 'Madiyalakan', 'Affiliation': 'OncoQuest inc., Edmonton, AB, Canada.'}, {'ForeName': 'Yolanda D', 'Initials': 'YD', 'LastName': 'Mahnke', 'Affiliation': 'FlowKnowHow LLC, New York, NY, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nicodemus', 'Affiliation': 'AIT Strategies, Franconia, NH, USA.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02537-4']
447,32219557,"Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).","BACKGROUND


Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan.
METHODS


In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed.
RESULTS


Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events.
CONCLUSION


IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.",2020,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","['Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40\xa0weeks', 'Japanese subjects with post-stroke upper-limb spasticity', 'Japanese subjects', 'Japan', 'Japanese subjects with upper-limb spasticity']","['incobotulinumtoxinA', 'single incobotulinumtoxinA injection', 'placebo', 'IncobotulinumtoxinA 400 U was superior versus placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA 400 U, 250 U, or matching placebo']","['Efficacy and safety', 'efficacy and safety', 'Modified Ashworth Scale (MAS) wrist score', 'muscle tone, improved functionality and was well tolerated', 'MAS wrist score', ""Disability Assessment Scale and Investigator's Clinical Global Impression scores""]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.358522,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Masakado', 'Affiliation': 'Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunitsugu', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Hospital, Tokushima City, Tokushima, Japan. rkaji@tokushima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09777-5']
448,32214297,Whole-Course Application of Dexmedetomidine Combined with Ketorolac in Nonnarcotic Postoperative Analgesia for Patients with Lung Cancer Undergoing Thoracoscopic Surgery: A Randomized Control Trial.,"BACKGROUND


Opioid-based postoperative analgesia provides adequate analgesia with much adverse effects and immunosuppression. Dexmedetomidine and ketorolac have properties of opioid-sparing, antiinflammation, and immune protection.
OBJECTIVES


To investigate the efficacy and safety of whole-course application of dexmedetomidine combined with ketorolac in nonnarcotic postoperative analgesia and its effect on inflammatory response and immune function in thoracoscopic surgery of lung cancer.
STUDY DESIGN


Double-blind, randomized control trial.
SETTING


The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
METHODS


Sixty patients scheduled for thoracoscopic surgery were enrolled and randomly divided into 2 groups to receive a combination of intraoperative usage of dexmedetomidine and postoperative patient-controlled intravenous analgesia of dexmedetomidine 0.1 µg/kg/h and ketorolac 3 mg/kg (DEX group) or only postoperative patient-controlled intravenous analgesia of sufentanil 1.5 µg/kg and ketorolac 3 mg/kg (SUF group) for 48 hours. Vital signs, postoperative Visual Analog Scale (VAS) score, Ramsay sedation score, patient-controlled analgesia pressing times, consumption of sufentanil and rescue drug, and complications were compared between the 2 groups. The levels of inflammatory factors and immune function were also compared.
RESULTS


A significant reduction in median blood pressures and heart rates within 48 hours after surgery and perioperative consumption of sufentanil were observed in the DEX group compared with the SUF group (P < 0.05). No statistically significant difference was found in VAS scores, patient-controlled analgesia pressing times, and rescue drug consumption between the 2 groups (P > 0.05). The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05). A significant decrease of interleukin (IL)-1 beta, IL-6, tumor necrosis factor (TNF)-alpha, and increased CD4+ and CD4+/CD8+ were observed in the DEX group compared with the SUF group at 24 and 48 hours after surgery (P < 0.05). There was no difference in the levels of CD8+ and natural killer cells between the 2 groups (P > 0.05).
LIMITATIONS


This study was limited by its sample size.
CONCLUSIONS


Whole-course application of dexmedetomidine combined with ketorolac in nonnarcotic postoperative analgesia provided adequate and safe postoperative analgesia, reduced sufentanil consumption, analgesia-related complications, alleviated inflammatory response, and immunosuppression compared with sufentanil-based analgesia in thoracoscopic surgery.
KEY WORDS


Dexmedetomidine, ketorolac, sufentanil, thoracoscopic surgery, postoperative analgesic, patient-controlled analgesia, inflammatory response, immune function.",2020,The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05).,"['Sixty patients scheduled for thoracoscopic surgery', 'Patients with Lung Cancer Undergoing Thoracoscopic Surgery', 'The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China', 'thoracoscopic surgery of lung cancer']","['DEX', 'Dexmedetomidine and ketorolac', 'SUF', 'dexmedetomidine', 'dexmedetomidine and postoperative patient-controlled intravenous analgesia of dexmedetomidine 0.1 µg/kg/h and ketorolac 3 mg/kg (DEX group) or only postoperative patient-controlled intravenous analgesia of sufentanil 1.5 µg/kg and ketorolac 3 mg/kg (SUF', 'Dexmedetomidine Combined with Ketorolac', 'dexmedetomidine combined with ketorolac', 'ketorolac', 'sufentanil-based analgesia', 'Dexmedetomidine, ketorolac, sufentanil']","['levels of CD8+ and natural killer cells', 'median blood pressures and heart rates', 'VAS scores, patient-controlled analgesia pressing times, and rescue drug consumption', 'nonnarcotic postoperative analgesia provided adequate and safe postoperative analgesia, reduced sufentanil consumption, analgesia-related complications, alleviated inflammatory response, and immunosuppression', 'efficacy and safety', 'perioperative consumption of sufentanil', 'interleukin (IL)-1 beta, IL-6, tumor necrosis factor (TNF)-alpha, and increased CD4+ and CD4+/CD8', ' thoracoscopic surgery, postoperative analgesic, patient-controlled analgesia, inflammatory response, immune function', 'inflammatory response and immune function', 'incidence of nausea', 'levels of inflammatory factors and immune function', 'Vital signs, postoperative Visual Analog Scale (VAS) score, Ramsay sedation score, patient-controlled analgesia pressing times, consumption of sufentanil and rescue drug, and complications']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0518766'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",60.0,0.188087,The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05).,"[{'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Fa-Chen', 'Initials': 'FC', 'LastName': 'Zhou', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Xin-Yu', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Lv', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Qian-Hao', 'Initials': 'QH', 'LastName': 'Hou', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Qing-Ping', 'Initials': 'QP', 'LastName': 'Wen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}]",Pain physician,[]
449,32130198,A Culturally Relevant Smartphone-Delivered Physical Activity Intervention for African American Women: Development and Initial Usability Tests of Smart Walk.,"BACKGROUND


Smart Walk is a culturally relevant, social cognitive theory-based, smartphone-delivered intervention designed to increase physical activity (PA) and reduce cardiometabolic disease risk among African American (AA) women.
OBJECTIVE


This study aimed to describe the development and initial usability testing results of Smart Walk.
METHODS


Smart Walk was developed in 5 phases. Phases 1 to 3 focused on initial intervention development, phase 4 involved usability testing, and phase 5 included intervention refinement based on usability testing results. In phase 1, a series of 9 focus groups with 25 AA women (mean age 38.5 years, SD 7.8; mean BMI 39.4 kg/m2, SD 7.3) was used to identify cultural factors associated with PA and ascertain how constructs of social cognitive theory can be leveraged in the design of a PA intervention. Phase 2 included the analysis of phase 1 qualitative data and development of the structured PA intervention. Phase 3 focused on the technical development of the smartphone app used to deliver the intervention. Phase 4 consisted of a 1-month usability trial of Smart Walk (n=12 women; mean age 35.0 years, SD 8.5; mean BMI 40 kg/m2, SD 5.0). Phase 5 included refinement of the intervention based on the usability trial results.
RESULTS


The 5-phase process resulted in the development of the Smart Walk smartphone-delivered PA intervention. This PA intervention was designed to target social cognitive theory constructs of behavioral capability, outcome expectations, social support, self-efficacy, and self-regulation and address deep structure sociocultural characteristics of collectivism, racial pride, and body appearance preferences of AA women. Key features of the smartphone app included (1) personal profile pages, (2) multimedia PA promotion modules (ie, electronic text and videos), (3) discussion boards, and (4) a PA self-monitoring tool. Participants also received 3 PA promotion text messages each week.
CONCLUSIONS


The development process of Smart Walk was designed to maximize the usability, cultural relevance, and impact of the smartphone-delivered PA intervention.",2020,"The development process of Smart Walk was designed to maximize the usability, cultural relevance, and impact of the smartphone-delivered PA intervention.","['AA women', '25 AA women (mean age 38.5 years, SD 7.8; mean BMI 39.4 kg/m2, SD 7.3', 'n=12 women; mean age 35.0 years, SD 8.5; mean BMI 40 kg/m2, SD 5.0', 'African American (AA) women', 'African American Women']","['Culturally Relevant Smartphone-Delivered Physical Activity Intervention', 'Smart Walk']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",[],,0.018132,"The development process of Smart Walk was designed to maximize the usability, cultural relevance, and impact of the smartphone-delivered PA intervention.","[{'ForeName': 'Rodney P', 'Initials': 'RP', 'LastName': 'Joseph', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Keller', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'English', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hollingshead', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Hooker', 'Affiliation': 'College of Health and Human Services, San Diego State University, San Diego, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Gaesser', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Ainsworth', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}]",JMIR mHealth and uHealth,['10.2196/15346']
450,32157678,Opioid tapering after spine surgery: Protocol for a randomized controlled trial.,"BACKGROUND


Patients are often prescribed opioids at discharge from hospital following surgery. Several studies have shown that a large number of patients do not taper off but continue to use opioids after surgery. Tapering plans and follow-up after discharge may reduce opioid consumption.
METHODS


This is a single-centre, investigator-initiated, randomized, controlled trial. One hundred and ten preoperative opioid users, scheduled to undergo spine surgery at Aarhus University Hospital, Denmark, are randomized into two groups: 1) an intervention group receiving an individually customized tapering plan at discharge combined with telephone counselling one week after discharge; 2) a control group receiving no tapering plan or telephone counselling. The primary outcome is number of patients exceeding their preoperative intake one month after discharge. Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.
CONCLUSION


Our study is expected to provide valuable information on opioid tapering after surgery in patients with preoperative opioid use.",2020,"Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.","['One hundred and ten preoperative opioid users, scheduled to undergo spine surgery at Aarhus University Hospital, Denmark', 'patients with preoperative opioid use', 'Opioid tapering after spine surgery']",['intervention group receiving an individually customized tapering plan at discharge combined with telephone counselling one week after discharge 2) a control group receiving no tapering plan or telephone counselling'],"['number of patients exceeding their preoperative intake one month after discharge', 'withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]",110.0,0.20544,"Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Uhrbrand', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Phillipsen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mikkel M', 'Initials': 'MM', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13576']
451,32212856,Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial.,"OBJECTIVE


Age-related cognitive decline, the deterioration in functions such as memory and executive function, is faced by most older adults and affects function and quality of life. No approved treatments exist for age-related cognitive decline. Computerized cognitive training has been shown to provide consistent albeit modest improvements in cognitive function as measured by neuropsychological testing. Vortioxetine, an antidepressant medication, has putative procognitive and proneuroplastic properties and therefore may be able to augment cognitive training. In this placebo-controlled study, the authors tested the cognitive benefits of vortioxetine added to cognitive training for adults age 65 or older with age-related cognitive decline.
METHODS


After a 2-week lead-in period of cognitive training, 100 participants were randomly assigned to receive either vortioxetine or placebo in addition to cognitive training for 26 weeks. The primary outcome measure was global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite. The secondary outcome measure was functional cognition, assessed by the UCSD Performance-Based Skills Assessment. All participants received motivational messaging and support from study staff to maximize adherence to the training.
RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. This separation was significant at week 12 but not at other assessment time points. Both groups showed improvement in the secondary outcome measure of functional cognition, with no significant difference between groups.
CONCLUSIONS


Vortioxetine may be beneficial for age-related cognitive decline when combined with cognitive training. These findings provide new treatment directions for combating cognitive decline in older adults.",2020,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","['adults age 65 or older with age-related cognitive decline', '100 participants', 'Age-Related Cognitive Decline', 'older adults']","['vortioxetine added to cognitive training', 'Computerized cognitive training', 'Computerized Cognitive Training With Vortioxetine', 'placebo', 'motivational messaging', 'vortioxetine or placebo', 'vortioxetine with cognitive training', 'Vortioxetine']","['cognitive function', 'global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite', 'global cognitive performance', 'functional cognition', 'functional cognition, assessed by the UCSD Performance-Based Skills Assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0729447', 'cui_str': 'Battery fluid (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",100.0,0.154771,"RESULTS


Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Jill D', 'Initials': 'JD', 'LastName': 'Waring', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Vy T', 'Initials': 'VT', 'LastName': 'Pham', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Shimony', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19050561']
452,31977517,Saline versus Lactated Ringer's Solution: The Saline or Lactated Ringer's (SOLAR) Trial.,"BACKGROUND


Both saline and lactated Ringer's solutions are commonly given to surgical patients. However, hyperchloremic acidosis consequent to saline administration may provoke complications. The authors therefore tested the primary hypothesis that a composite of in-hospital mortality and major postoperative complications is less common in patients given lactated Ringer's solution than normal saline.
METHODS


The authors conducted an alternating cohort controlled trial in which adults having colorectal and orthopedic surgery were given either lactated Ringer's solution or normal saline in 2-week blocks between September 2015 and August 2018. The primary outcome was a composite of in-hospital mortality and major postoperative renal, respiratory, infectious, and hemorrhagic complications. The secondary outcome was postoperative acute kidney injury.
RESULTS


Among 8,616 qualifying patients, 4,187 (49%) were assigned to lactated Ringer's solution, and 4,429 (51%) were assigned to saline. Each group received a median 1.9 l of fluid. The primary composite of major complications was observed in 5.8% of lactated Ringer's versus 6.1% of normal saline patients, with estimated average relative risk across the components of the composite of 1.16 (95% CI, 0.89 to 1.52; P = 0.261). The secondary outcome, postoperative acute kidney injury, Acute Kidney Injury Network stage I-III versus 0, occurred in 6.6% of lactated Ringer's patients versus 6.2% of normal saline patients, with an estimated relative risk of 1.18 (99.3% CI, 0.99 to 1.41; P = 0.009, significance criterion of 0.007). Absolute differences between the treatment groups for each outcome were less than 0.5%, an amount that is not clinically meaningful.
CONCLUSIONS


In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement. Clinicians can reasonably use either solution intraoperatively.",2020,"In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement.","['adults having colorectal and orthopedic surgery', '8,616 qualifying patients, 4,187 (49', 'elective orthopedic and colorectal surgery patients']","[""lactated Ringer's solution"", ""lactated Ringer's solution or normal saline"", ""Saline versus Lactated Ringer's Solution"", ""Saline or Lactated Ringer's"", ""saline and lactated Ringer's solutions""]","['postoperative complications', 'composite of in-hospital mortality and major postoperative renal, respiratory, infectious, and hemorrhagic complications', 'postoperative acute kidney injury', 'postoperative acute kidney injury, Acute Kidney Injury Network stage I-III versus 0', 'major complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",8616.0,0.722242,"In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': ""From the Department of General Anesthesiology (K.M., A.T., W.A.S.E., K.R., S.B., A.G.K., M.R.R., T.K., G.R.B., A.K.) Department of Outcomes Research (K.M., A.T., N.M., C.M., K.R., H.E., B.C., I.S., G.R.B., D.C., E.J.M., A.K., D.I.S.) Department of Quantitative Health Sciences (N.M., C.M., E.J.M.) Department of Orthopedic Surgery (C.H.-R.), Cleveland Clinic, Cleveland, Ohio the Division of Colon and Rectal Surgery, Mayo Clinic, Jacksonville, Florida (L.S.) the Division of Anesthesia, Critical Care, and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel (B.C.) the Department of Anesthesia, St. Elizabeth's Medical Center, Boston, Massachusetts (I.S.).""}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': ''}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'Barsoum', 'Affiliation': ''}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Kuhel', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Ritchey', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Higuera-Rueda', 'Affiliation': ''}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Kopyeva', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Stocchi', 'Affiliation': ''}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Essber', 'Affiliation': ''}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Suleiman', 'Affiliation': ''}, {'ForeName': 'Gausan R', 'Initials': 'GR', 'LastName': 'Bajracharya', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chelnick', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003130']
453,31468473,Limited correlation between systemic biomarkers and neurocognitive performance before and during HIV treatment.,"The AIDS Clinical Trials Group (ACTG) study A5303 investigated the associations between neuropsychological performance (NP) and inflammatory biomarkers in HIV-infected participants. Fifteen NP tests were administered at baseline and week 48 to 233 ART naïve participants randomized to maraviroc- or tenofovir-containing ART. Neurocognition correlated modestly with markers of lymphocyte activation and inflammation pre-ART (percent CD38+/HLA-DR+(CD4+) (r = - 0.22, p = 0.02) and percent CD38+/HLA-DR+(CD8+) (r = - 0.25, p = 0.02)), and with some monocyte subsets during ART (r = 0.25, p = 0.02). Higher interleukin-6 and percent CD38+/HLA-DR+(CD8+) were independently associated with worse severity of HIV-associated neurocognitive disorders (HAND) (p = 0.04 and 0.01, respectively). More studies to identify HAND biomarkers are needed.",2020,"Higher interleukin-6 and percent CD38+/HLA-DR+(CD8+) were independently associated with worse severity of HIV-associated neurocognitive disorders (HAND) (p = 0.04 and 0.01, respectively).",['HIV-infected participants'],['maraviroc- or tenofovir-containing ART'],"['neuropsychological performance (NP) and inflammatory biomarkers', 'severity of HIV-associated neurocognitive disorders (HAND', 'lymphocyte activation and inflammation pre-ART']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive Disorders'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024262', 'cui_str': 'Lymphoblast Transformation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]",233.0,0.143431,"Higher interleukin-6 and percent CD38+/HLA-DR+(CD8+) were independently associated with worse severity of HIV-associated neurocognitive disorders (HAND) (p = 0.04 and 0.01, respectively).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'Department of Neurology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Department of Microbial Pathogens and Immunity, Rush Medical College, Chicago, IL, USA.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Vecchio', 'Affiliation': 'Department of Neurology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Mary Clare', 'Initials': 'MC', 'LastName': 'Masters', 'Affiliation': 'Division of Infectious Diseases, Northwestern Univeristy, 645 N. Michigan Avenue, Suite 900, Chicago, IL, 60611, USA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Departmet of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Babafemi O', 'Initials': 'BO', 'LastName': 'Taiwo', 'Affiliation': 'Division of Infectious Diseases, Northwestern Univeristy, 645 N. Michigan Avenue, Suite 900, Chicago, IL, 60611, USA. b-taiwo@northwestern.edu.'}]",Journal of neurovirology,['10.1007/s13365-019-00795-2']
454,31498030,Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.,"PURPOSE


Outcome measures that comprehensively capture attributes of immuno-oncology agents, including prolonged treatment-free time and persistent treatment-related adverse events (TRAEs), are needed to complement conventional survival end points.
METHODS


We pooled data from the CheckMate 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for patients with advanced melanoma. Treatment-free survival (TFS) was defined as the area between Kaplan-Meier curves for two conventional time-to-event end points, each defined from random assignment: time to immune checkpoint inhibitor (ICI) protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was partitioned as time with and without toxicity by a third end point, time to cessation of both ICI therapy and toxicity. Toxicity included persistent and late-onset grade 3 or higher TRAEs. The area under each Kaplan-Meier curve was estimated by the 36-month restricted mean time.
RESULTS


At 36 months, many of the 1,077 patients who initiated ICI therapy were surviving free of subsequent therapy initiation (47% nivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab). The restricted mean TFS was longer for nivolumab plus ipilimumab (11.1 months) compared with nivolumab (4.6 months; difference, 6.5 months; 95% CI, 5.0 to 8.0 months) or ipilimumab (8.7 months; difference, 2.4 months; 95% CI, 0.8 to 4.1 months); restricted mean TFS represented 31% (3% with and 28% without toxicity), 13% (1% and 11%), and 24% (less than 1% and 23%) of the 36-month period, respectively, in the three treatment groups. TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
CONCLUSION


The analysis of TFS between ICI cessation and subsequent therapy initiation revealed longer TFS without toxicity for patients with advanced melanoma who received nivolumab plus ipilimumab compared with nivolumab or ipilimumab. Regardless of treatment, a small proportion of the TFS involved grade 3 or higher TRAEs.",2019,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","['Patients With Advanced Melanoma', 'patients with advanced melanoma']","['nivolumab plus ipilimumab', 'Immune Checkpoint Inhibition', 'ipilimumab', 'nivolumab or ipilimumab', 'nivolumab and ipilimumab', 'TFS']","['Treatment-free survival (TFS', 'TFS without toxicity', 'surviving free of subsequent therapy initiation', 'mean TFS', 'Treatment-Free Survival', 'Toxicity included persistent and late-onset grade 3 or higher TRAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1077.0,0.196501,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","[{'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gupte-Singh', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, PA.'}, {'ForeName': 'Harriet M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ritchings', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Emory University and Winship Comprehensive Cancer Center, Atlanta, GA.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00345']
455,32090192,"Randomized Phase II Trial of Exercise, Metformin, or Both on Metabolic Biomarkers in Colorectal and Breast Cancer Survivors.","Background


Observational data support inverse relationships between exercise or metformin use and disease outcomes in colorectal and breast cancer survivors, although the mechanisms underlying these associations are not well understood.
Methods


In a phase II trial, stage I-III colorectal and breast cancer survivors who completed standard therapy were randomly assigned to structured exercise or metformin or both or neither for 12 weeks. The primary outcome was change in fasting insulin levels; secondary outcomes included changes in other blood-based energetic biomarkers and anthropometric measurements. Analyses used linear mixed models.
Results


In total, 139 patients were randomly assigned; 91 (65%) completed follow-up assessments. Fasting insulin levels statistically significantly decreased in all three intervention arms (-2.47 μU/mL combination arm, -0.08 μU/mL exercise only, -1.16 μU/mL metformin only, + 2.79 μU/mL control arm). Compared with the control arm, all groups experienced statistically significant weight loss between baseline and 12 weeks (-1.8% combination arm, -0.22% exercise only, -1.0% metformin only, +1.55% control). The combination arm also experienced statistically significant improvements in the homeostatic model assessment for insulin resistance (-30.6% combination arm, +61.2% control) and leptin (-42.2% combination arm, -0.8% control), compared with the control arm. The interventions did not change insulin-like growth factor-1 or insulin-like growth factor binding protein-3 measurements as compared with the control arm. Tolerance to metformin limited compliance (approximately 50% of the participants took at least 75% of the planned dosages in both treatment arms).
Conclusions


The combination of exercise and metformin statistically significantly improved insulin and associated metabolic markers, as compared to the control arm, with potential greater effect than either exercise or metformin alone though power limited formal synergy testing. Larger efforts are warranted to determine if such a combined modality intervention can improve outcomes in colorectal and breast cancer survivors.",2020,The interventions did not change insulin-like growth factor-1 or insulin-like growth factor binding protein-3 measurements as compared with the control arm.,"['139 patients were randomly assigned; 91 (65%) completed follow-up assessments', 'stage I-III colorectal and breast cancer survivors who completed standard therapy', 'Colorectal and Breast Cancer Survivors', 'colorectal and breast cancer survivors']","['metformin', 'μU', 'Exercise, Metformin', 'exercise or metformin', 'exercise and metformin', 'structured exercise or metformin']","['homeostatic model assessment for insulin resistance', 'weight loss', 'change in fasting insulin levels; secondary outcomes included changes in other blood-based energetic biomarkers and anthropometric measurements', 'insulin and associated metabolic markers', 'leptin', 'Fasting insulin levels', 'change insulin-like growth factor-1 or insulin-like growth factor binding protein-3 measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0523722', 'cui_str': 'Insulin-like growth factor binding protein 3 level'}]",139.0,0.0836082,The interventions did not change insulin-like growth factor-1 or insulin-like growth factor binding protein-3 measurements as compared with the control arm.,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollak', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sorrentino', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Abrams', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}]",JNCI cancer spectrum,['10.1093/jncics/pkz096']
456,32217654,The natural history of progressive fibrosing interstitial lung diseases.,"We used data from the INBUILD and INPULSIS trials to investigate the natural history of progressive fibrosing interstitial lung diseases (ILDs).Subjects in the two INPULSIS trials had a clinical diagnosis of idiopathic pulmonary fibrosis (IPF) while subjects in the INBUILD trial had a progressive fibrosing ILD other than IPF and met protocol-defined criteria for ILD progression despite management. Using data from the placebo groups, we compared the rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality over 52 weeks in the INBUILD trial with pooled data from the INPULSIS trials.The adjusted mean annual rate of decline in FVC in the INBUILD trial (n=331) was similar to that observed in the INPULSIS trials (n=423) (-192.9 mL·year -1  and -221.0 mL·year -1 , respectively; nominal p-value=0.19). The proportion of subjects who had a relative decline in FVC >10% predicted at Week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials. A relative decline in FVC >10% predicted was associated with an increased risk of death in the INBUILD trial (hazard ratio 3.64) and the INPULSIS trials (hazard ratio 3.95).These findings indicate that patients with fibrosing ILDs other than IPF, who are progressing despite management, have a subsequent clinical course similar to patients with untreated IPF, with a high risk of further ILD progression and early mortality.",2020,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.",[],['placebo'],"['rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality', 'risk of death']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.169527,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.","[{'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Dept of Medicine, National Jewish Health, Denver, CO, USA brownk@njhealth.org.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Dept of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Simon L F', 'Initials': 'SLF', 'LastName': 'Walsh', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Thannickal', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Prasse', 'Affiliation': 'Dept of Respiratory Medicine, MHH Hannover Medical School and Biomedical Research in Endstage and Obstructive Lung Disease (BREATH), Deutsches Zentrum für Lungenforschung (DZL), Hannover, Germany.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Rainer-Georg', 'Initials': 'RG', 'LastName': 'Goeldner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Clerisme-Beaty', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, UMR 754, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}]",The European respiratory journal,['10.1183/13993003.00085-2020']
457,31529452,Association Between Features of Spontaneous Late Preterm Labor and Late Preterm Birth.,"OBJECTIVE


This study aimed to evaluate the association between clinical and examination features at admission and late preterm birth.
STUDY DESIGN


The present study is a secondary analysis of a randomized trial of singleton pregnancies at 34 0/7  to 36 5/7  weeks' gestation. We included women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term). We calculated a statistical cut-point optimizing the sensitivity and specificity of initial cervical dilation and effacement at predicting preterm birth and used multivariable regression to identify factors associated with late preterm delivery.
RESULTS


A total of 431 out of 732 (59%) women delivered preterm. Cervical dilation ≥ 4 cm was 60% sensitive and 68% specific for late preterm birth. Cervical effacement ≥ 75% was 59% sensitive and 65% specific for late preterm birth. Earlier gestational age at randomization, nulliparity, and fetal malpresentation were associated with late preterm birth. The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
CONCLUSION


Four in 10 women in late-preterm labor subsequently delivered at term. Combination of examination and clinical features (including parity and gestational age) improved late-preterm birth prediction.",2020,"The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
","['A total of 431 out of 732 (59%) women delivered preterm', ""singleton pregnancies at 34 0/7  to 36 5/7  weeks' gestation"", 'women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term']",[],"['late-preterm birth prediction', 'late preterm birth prediction']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",431.0,0.248677,"The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
","[{'ForeName': 'Angelica V', 'Initials': 'AV', 'LastName': 'Glover', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lucky', 'Initials': 'L', 'LastName': 'Jain', 'Affiliation': 'Department of Obstetrics and Gynecology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Erin A S', 'Initials': 'EAS', 'LastName': 'Clark', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Norton', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, California.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburg, Pittsburg, Pennsylvania.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Manuck', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1696641']
458,31553639,Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study.,"PURPOSE


The treatment of childhood nasopharyngeal carcinoma has been adapted from adult regimens; pediatric-specific studies are limited. The ARAR0331 study sought to evaluate the impact of induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR).
PATIENTS AND METHODS


Patients with American Joint Committee on Cancer stages IIb to IV were scheduled to receive three cycles of IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin. Patients with complete or partial response to IC received 61.2 Gy to the nasopharynx and neck, and patients with stable disease received 71.2 Gy.
RESULTS


Between February 2006 and January 2012, 111 patients (75 male) were enrolled. Median age was 15 years, and 46.8% of the patients were African American. After a feasibility analysis, the study was amended to reduce cisplatin to two cycles during CCR. The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively. The 5-year EFS for stages IIb, III, and IV were 100%, 82.8%, and 82.7%, respectively. The 5-year cumulative incidence estimates of local, distant, and combined relapse were 3.7%, 8.7%, and 1.8%, respectively. Patients treated with three versus two CCR cycles of cisplatin had improved 5-year postinduction EFS (90.7%  v  81.2%,  P  = .14).
CONCLUSION


Patients in ARAR0331 were characterized by advanced disease and by a high proportion of black children and adolescents. Treatment with IC and CRT resulted in excellent outcomes. A radiation dose reduction is possible for patients responding to IC. Although the outcomes are comparable, we observed a trend toward decreased EFS for patients assigned to receive fewer doses of cisplatin during CCR.",2019,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","['Childhood Nasopharyngeal Carcinoma', 'Between February 2006 and January 2012, 111 patients (75 male) were enrolled', 'Median age was 15 years, and 46.8% of the patients were African American', 'Patients with American Joint Committee on Cancer stages IIb to IV']","['IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin', 'induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR', 'Induction Chemotherapy and Concurrent Chemoradiotherapy', 'cisplatin', 'IC and CRT']","['5-year cumulative incidence estimates of local, distant, and combined relapse', '5-year event-free survival (EFS) and overall survival estimates', '5-year EFS', '5-year postinduction EFS']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",111.0,0.110512,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Galindo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Krasin', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'M Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Pashankar', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Pappo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01276']
459,31112475,Positron Emission Tomography Score Has Greater Prognostic Significance Than Pretreatment Risk Stratification in Early-Stage Hodgkin Lymphoma in the UK RAPID Study.,"PURPOSE


Accurate stratification of patients is an important goal in Hodgkin lymphoma (HL), but the role of pretreatment clinical risk stratification in the context of positron emission tomography (PET) -adapted treatment is unclear. We performed a subsidiary analysis of the RAPID trial to assess the prognostic value of pretreatment risk factors and PET score in determining outcomes.
PATIENTS AND METHODS


Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine; 143 PET-positive patients (PET score, 3 to 5) received a fourth doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy, and 419 patients in complete metabolic remission were randomly assigned to receive involved-field radiotherapy (n = 208) or no additional treatment (n = 211). Cox regression was used to investigate the association between PET score and pretreatment risk factors with HL-specific event-free survival (EFS).
RESULTS


High PET score was associated with inferior EFS, before ( P  < .001) and after adjustment ( P  = .01) for baseline risk stratification. Only patients with a postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake) had an increased risk of progression or HL-related death (hazard ratio, 9.4  v  score of 3; 95% CI, 2.8 to 31.3 and hazard ratio, 6.7  v  score of 4; 95% CI, 1.4 to 31.7). Patients with a PET score of 5 also had inferior progression-free and overall survival. There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
CONCLUSION


In RAPID, a positive PET scan did not carry uniform prognostic weight; only a PET score of 5 was associated with inferior outcomes. This suggests that in future trials involving patients without B symptoms or mediastinal bulk, a score of 5 rather than a positive PET result should be used to guide treatment escalation in early-stage HL.",2019,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
","['Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of', '143 PET-positive patients (PET score, 3 to 5) received a fourth', '419 patients in complete metabolic remission']","['doxorubicin, bleomycin, vinblastine, and dacarbazine', 'receive involved-field radiotherapy (n = 208) or no additional treatment', 'doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy']","['postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake', 'inferior progression-free and overall survival', 'Positron Emission Tomography Score', 'risk of progression or HL-related death (hazard ratio', 'PET score and pretreatment risk factors with HL-specific event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457150', 'cui_str': 'Stage Ia'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.216386,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
","[{'ForeName': 'Sally F', 'Initials': 'SF', 'LastName': 'Barrington', 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Phillips', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': '3 University of Sheffield and Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""4 St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': '5 Cancer Research UK Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Townsend', 'Affiliation': '6 University College Hospital London, London, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Culligan', 'Affiliation': '7 Aberdeen Royal Infirmary, Aberdeen, United Kingdom.'}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Popova', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': '8 Nottingham City Hospitals National Health Service (NHS) Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': '9 Mount Vernon Hospital, Middlesex, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': ""O'Doherty"", 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01799']
460,32215897,Strength Training Induces Greater Increase in Handgrip Strength than Wrestling Training per se.,"This study investigated the effectiveness of a specialized strength training program on maximal handgrip strength in young wrestlers. 72 young wrestlers (36 children: 8-10 years-old and 36 adolescents:13-15 years-old) participated in the present study. Both age-categories were assigned into a training group (18 children and 18 adolescents) and a control group (18 children and 18 adolescents). The training groups, in conjunction with the wrestling training performed a 4-month (2 sessions/week) specialized handgrip training program. Maximal handgrip strength was evaluated pre, at the intermediate (2 months) and at the completion of the program (4 months). Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001). No significant differences were observed on pre-training and intermediate measurements between groups, while significant differences were observed during the post-training measurement. Training group exhibited significantly (p<0.01) greater maximal handgrip strength values than the control group irrespective of age-category and hand-preference. A 4-month handgrip strength training program, incorporated into the conventional wrestling training, provokes greater adaptations in maximal handgrip strength than the wrestling training per se. For greater handgrip training adaptations are required more than 14 specialized handgrip training-sessions.",2020,Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001).,"['72 young wrestlers (36 children: 8-10 years-old and 36 adolescents:13-15 years-old) participated in the present study', 'Both age-categories were assigned into a training group (18 children and 18 adolescents) and a control group (18 children and 18 adolescents', 'young wrestlers']","['Strength Training', 'handgrip strength training program', 'specialized strength training program', 'specialized handgrip training program']","['maximal handgrip strength', 'pre-training and intermediate measurements', 'Maximal handgrip strength', 'Maximal handgrip strength values', 'maximal handgrip strength values', 'Handgrip Strength']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.00858051,Maximal handgrip strength values increased during the intermediate and post-training measurements compared to pre-training measurement in training and control groups (p<0.001).,"[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Karatrantou', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Katsoula', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Tsiakaras', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Ioakimidis', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Gerodimos', 'Affiliation': 'Department of Physical Education and Sports Science, University of Thessaly, Trikala, Greece.'}]",International journal of sports medicine,['10.1055/a-1128-7166']
461,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE


Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS


Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS


Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27;  P  = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59;  P  = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P  < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9%  v  10.7%, respectively), febrile neutropenia (35.0%  v  17.7%, respectively), mucositis (8.4%  v  2.1%, respectively), and neuropathy (18.6%  v  3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION


In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
462,30995174,Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer.,"PURPOSE


The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.
PATIENTS AND METHODS


A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.
RESULTS


The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9%  v  4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.
CONCLUSION


Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.",2019,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","['High-Intermediate and High-Risk Early Stage Endometrial Cancer', 'The median age of the 601 patients was 63 years, and 74% had stage I disease', 'high-intermediate and high-risk early-stage endometrial carcinoma', 'eligible patients with endometrial cancer', 'Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage']","['Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin', 'vaginal cuff brachytherapy and chemotherapy (VCB/C', 'pelvic radiation therapy (RT', 'Pelvic RT alone', 'VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin']","['recurrence-free survival (RFS', 'Pelvic or para-aortic nodal recurrences', 'RFS or overall survival', '60-month overall survival', '60-month RFS', 'Vaginal and distant recurrence rates', 'Acute toxicity']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.213594,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","[{'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Randall', 'Affiliation': '1 University of Kentucky, Lexington, KY.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'McMeekin', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'von Gruenigen', 'Affiliation': '4 Summa Health System, Akron, OH.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'Catheryn M', 'Initials': 'CM', 'LastName': 'Yashar', 'Affiliation': '5 University of California San Diego, San Diego, CA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': '6 Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': '7 Ohio State University, Columbus, OH.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '8 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': '9 Mercer University, Savannah, GA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutherford', 'Affiliation': '10 Yale University, New Haven, CT.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""11 Women's Cancer Center of Nevada, Las Vegas, NV.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': '12 University of Hawaii, Honolulu, HI.'}, {'ForeName': 'Penny R', 'Initials': 'PR', 'LastName': 'Anderson', 'Affiliation': '13 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Brewster', 'Affiliation': '14 University of North Carolina Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': '15 Loyola University, Chicago, IL.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': '16 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': '17 University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01575']
463,31910279,Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial.,"Importance


Dietary supplements marketed for male fertility commonly contain folic acid and zinc based on limited prior evidence for improving semen quality. However, no large-scale trial has examined the efficacy of this therapy for improving semen quality or live birth.
Objective


To determine the effect of daily folic acid and zinc supplementation on semen quality and live birth.
Design, Setting, and Participants


The Folic Acid and Zinc Supplementation Trial was a multicenter randomized clinical trial. Couples (n = 2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017. The last 6-month study visit for semen collection occurred during August 2018, with chart abstraction of live birth and pregnancy information completed during April 2019.
Interventions


Men were block randomized by study center and planned infertility treatment (in vitro fertilization, other treatment at a study site, and other treatment at an outside clinic) to receive either 5 mg of folic acid and 30 mg of elemental zinc (n = 1185) or placebo (n = 1185) daily for 6 months.
Main Outcomes and Measures


The co-primary outcomes were live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count) at 6 months after randomization.
Results


Among 2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit. Live birth outcomes were available for all couples, and 1629 men (69%) had semen available for analysis at 6 months after randomization. Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]). Most of the semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count) were not significantly different between treatment groups at 6 months after randomization. A statistically significant increase in DNA fragmentation was observed with folic acid and zinc supplementation (mean of 29.7% for percentage of DNA fragmentation in the folic acid and zinc group and 27.2% in the placebo group; mean difference, 2.4% [95% CI, 0.5% to 4.4%]). Gastrointestinal symptoms were more common with folic acid and zinc supplementation compared with placebo (abdominal discomfort or pain: 66 [6%] vs 40 [3%], respectively; nausea: 50 [4%] vs 24 [2%]; and vomiting: 32 [3%] vs 17 [1%]).
Conclusions and Relevance


Among a general population of couples seeking infertility treatment, the use of folic acid and zinc supplementation by male partners, compared with placebo, did not significantly improve semen quality or couples' live birth rates. These findings do not support the use of folic acid and zinc supplementation by male partners in the treatment of infertility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01857310.",2020,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","['Couples (n\u2009', 'Couples Undergoing Infertility Treatment', '2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit', '2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017']","['planned infertility treatment (in vitro fertilization', 'placebo', 'folic acid and zinc', 'daily folic acid and zinc supplementation', 'folic acid and zinc supplementation', 'folic acid and 30 mg of elemental zinc (n\u2009=\u20091185) or placebo', 'Folic Acid and Zinc Supplementation']","['Live birth', 'Live birth outcomes', 'vomiting', 'semen quality and live birth', 'DNA fragmentation', 'nausea', 'Gastrointestinal symptoms', 'live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count', 'Semen Quality and Live Birth', 'semen quality or live birth', 'semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count', ""semen quality or couples' live birth rates""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",2370.0,0.613709,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","[{'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Departments of Surgery (Urology) and Human Genetics, School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Van Voorhis', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hotaling', 'Affiliation': ""Center for Reconstructive Urology and Men's Health, Departments of Surgery (Urology) and Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",JAMA,['10.1001/jama.2019.18714']
464,32162448,Ultrasonographic evaluation of gastric emptying after ingesting carbohydrate-rich drink in young children: A randomized crossover study.,"BACKGROUND


A recent consensus statement in Europe has suggested that the fasting time for clear liquid in children can be shortened to 1 hour before a surgery. However, the study to show that 1-hour fasting time for clear fluids is safe in young children is still lacking. This study aimed to investigate the gastric emptying time for carbohydrate-rich drink and regular 5% glucose solution in children aged 3-7 years.
METHODS


After overnight fasting, individuals were randomly assigned to ingest 5 mL kg -1  of either carbohydrate-rich drink or 5% glucose solution. One week later, the same subjects were asked to ingest the other one. Ultrasonography was performed to examine the gastric contents. Gastric antral cross-sectional area was measured, and the gastric fluid volume was calculated before and after fluid ingestion within 120 minutes. The primary outcome was the gastric emptying time for both the clear fluids calculated using the antral cross-sectional area and logarithms of gastric fluid volume. The degrees of thirst and hunger of two drinks were evaluated using a visual analogue scale as the secondary outcomes.
RESULTS


Data from 16 individuals were analyzed. In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion. However, in the carbohydrate-rich drink group, the median [interquartile range; range] antral cross-sectional area (3.69 [2.64-5.15; 1.83-8.93] cm 2  vs 2.41 [2.10-2.96; 1.81-4.37] cm 2  , P < .001) and mean (95% confidence interval) logarithms of gastric fluid volume (2.54 [2.30-2.79] mL vs 2.12 [1.94-2.30] mL, P = .048) were still higher than at 60 minutes and returned to the baseline values at 90 minutes after ingestion, respectively. The degree of thirst was lower in the glucose solution group than that in the carbohydrate-rich drink group.
CONCLUSIONS


Gastric emptying of carbohydrate-rich drink is slower than that of 5% glucose solution but the residual gastric fluid volume is low one hour after ingestion of 5 mL kg -1  of either fluid.",2020,"In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion.","['children aged 3-7\xa0years', 'young children']","['carbohydrate-rich drink', 'ingest 5\xa0mL\xa0kg -1  of either carbohydrate-rich drink or 5% glucose solution', 'Ultrasonography', 'carbohydrate-rich drink and regular 5% glucose solution']","['gastric emptying time for both the clear fluids calculated using the antral cross-sectional area and logarithms of gastric fluid volume', 'Gastric antral cross-sectional area', 'gastric fluid volume', 'gastric emptying time', 'antral cross-sectional area and logarithms of gastric fluid volume', 'residual gastric fluid volume', 'degree of thirst']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453847', 'cui_str': 'Clear fluid (substance)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}]",16.0,0.106341,"In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion.","[{'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Qiu', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ru-Ping', 'Initials': 'RP', 'LastName': 'Dai', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Paediatric anaesthesia,['10.1111/pan.13853']
465,30552157,Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab for Metastatic Colorectal Cancer (STEAM).,"BACKGROUND


First-line treatment for metastatic colorectal cancer (mCRC) typically entails a biologic such as bevacizumab (BEV) with 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) or 5-fluorouracil/leucovorin/irinotecan (FOLFIRI). STEAM (NCT01765582) assessed the efficacy of BEV plus FOLFOX/FOLFIRI (FOLFOXIRI), administered concurrently (cFOLFOXIRI-BEV) or sequentially (sFOLFOXIRI-BEV, FOLFOX-BEV alternating with FOLFIRI-BEV), versus FOLFOX-BEV for mCRC.
PATIENTS AND METHODS


Patients with previously untreated mCRC ( n  = 280) were randomized 1:1:1 to cFOLFOXIRI-BEV, sFOLFOXIRI-BEV, or FOLFOX-BEV and treated with 4-6-month induction followed by maintenance. Coprimary objectives were overall response rate (ORR; first-line cFOLFOXIRI-BEV vs. FOLFOX-BEV) and progression-free survival (PFS; pooled first-line cFOLFOXIRI-BEV and sFOLFOXIRI-BEV vs. FOLFOX-BEV). Secondary/exploratory objectives included overall survival (OS), liver resection rates, biomarker analyses, and safety.
RESULTS


ORR was 72.0%, 72.8%, and 62.1% and median PFS was 11.9, 11.4, and 9.5 months with cFOLFOXIRI-BEV, sFOLFOXIRI-BEV, and FOLFOX-BEV, respectively. OS was similar between arms. ORR between cFOLFOXIRI-BEV and FOLFOX-BEV did not significantly differ ( p  = .132); thus, the primary ORR endpoint was not met. cFOLFOXIRI-BEV and sFOLFOXIRI-BEV numerically improved ORR and PFS, regardless of  RAS  status. Median PFS was higher with pooled concurrent and sequential FOLFOXIRI-BEV versus FOLFOX-BEV (11.7 vs. 9.5 months; hazard ratio, 0.7; 90% confidence interval, 0.5-0.9;  p  < .01). Liver resection rates were 17.2% (cFOLFOXIRI-BEV), 9.8% (sFOLFOXIRI-BEV), and 8.4% (FOLFOX-BEV). Grade ≥ 3 treatment-emergent adverse events (TEAEs) were observed in 91.2% (cFOLFOXIRI-BEV), 86.7% (sFOLFOXIRI-BEV), and 85.6% (FOLFOX-BEV) of patients, with no increase in serious chemotherapy-associated TEAEs.
CONCLUSION


cFOLFOXIRI-BEV and sFOLFOXIRI-BEV were well tolerated with numerically improved ORR, PFS, and liver resection rates versus FOLFOX-BEV, supporting triplet chemotherapy plus BEV as a first-line treatment option for mCRC .  IMPLICATIONS FOR PRACTICE: The combination of first-line FOLFIRI with FOLFOX and bevacizumab (concurrent FOLFOXIRI-BEV) improves clinical outcomes in patients with metastatic colorectal cancer (mCRC) relative to FOLFIRI-BEV or FOLFOX-BEV, but it is thought to be associated with increased toxicity. Alternating treatment of FOLFOX and FOLFIRI (sequential FOLFOXIRI-BEV) could improve tolerability. In the phase II STEAM trial, which is the largest study of FOLFOXIRI-BEV in patients in the U.S., it was found that both concurrent and sequential FOLFOXIRI-BEV are active and well tolerated in patients with previously untreated mCRC, supporting the use of these regimens as potential first-line treatment options for this population.",2019,"cFOLFOXIRI-BEV and sFOLFOXIRI-BEV were well tolerated with numerically improved ORR, PFS, and liver resection rates versus FOLFOX-BEV, supporting triplet chemotherapy plus BEV as a first-line treatment option for mCRC .  ","['Metastatic Colorectal Cancer (STEAM', 'patients with metastatic colorectal cancer (mCRC', 'Patients with previously untreated mCRC ( n  = 280', 'metastatic colorectal cancer (mCRC']","['bevacizumab (BEV) with 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) or 5-fluorouracil/leucovorin/irinotecan (FOLFIRI', 'FOLFOX and FOLFIRI (sequential FOLFOXIRI-BEV', 'cFOLFOXIRI-BEV, sFOLFOXIRI-BEV, or FOLFOX-BEV and treated with 4-6-month induction followed by maintenance', 'Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab', 'FOLFOX and bevacizumab (concurrent FOLFOXIRI-BEV']","['tolerability', 'ORR, PFS, and liver resection rates', 'ORR between cFOLFOXIRI-BEV and FOLFOX-BEV', 'Liver resection rates', 'toxicity', 'efficacy of BEV plus FOLFOX/FOLFIRI (FOLFOXIRI), administered concurrently (cFOLFOXIRI-BEV) or sequentially (sFOLFOXIRI-BEV, FOLFOX-BEV alternating with FOLFIRI-BEV), versus FOLFOX-BEV for mCRC', 'Grade ≥', 'ORR', 'overall response rate (ORR; first-line cFOLFOXIRI-BEV vs. FOLFOX-BEV) and progression-free survival (PFS; pooled first-line cFOLFOXIRI-BEV and sFOLFOXIRI-BEV vs. FOLFOX-BEV', 'median PFS', 'overall survival (OS), liver resection rates, biomarker analyses, and safety', 'Median PFS']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",280.0,0.0227949,"cFOLFOXIRI-BEV and sFOLFOXIRI-BEV were well tolerated with numerically improved ORR, PFS, and liver resection rates versus FOLFOX-BEV, supporting triplet chemotherapy plus BEV as a first-line treatment option for mCRC .  ","[{'ForeName': 'Herbert I', 'Initials': 'HI', 'LastName': 'Hurwitz', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA hurwitz.herbert@gene.com.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Tan', 'Affiliation': 'Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Reeves', 'Affiliation': 'Florida Cancer Specialists - South Region, Ft. Myers, Florida, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'The Center for Cancer and Blood Disorders, Fort Worth, Texas, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Somer', 'Affiliation': 'West Clinic, Memphis, Tennessee, USA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, California, USA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scappaticci', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Palma', 'Affiliation': 'Roche Sequencing Solutions, Pleasanton California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Roche Sequencing Solutions, Pleasanton California, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Nicholas', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sommer', 'Affiliation': 'Genentech, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, USA.'}]",The oncologist,['10.1634/theoncologist.2018-0344']
466,32402702,Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.,"BACKGROUND


Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients.
METHODS


The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
RESULTS


More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea.
CONCLUSION


This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",2020,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","['high-risk PCI patients', 'high-risk patients who underwent percutaneous coronary intervention', 'patients with high-risk anatomic or clinical characteristics who underwent PCI', '1700 high-risk PCI patients']","['routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing', 'routine versus no routine functional testing', 'percutaneous coronary intervention (PCI) with drug-eluting stents (DES']","['composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0562340', 'cui_str': 'Poor daily routine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0929061,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","[{'ForeName': 'Yong-Hoon', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': ""Cardiovascular Center and Cardiology Division, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Su Nam', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.03.019']
467,32130181,Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial.,"BACKGROUND


There are over 2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year. During 2017-2018, the National Yang-Ming University, the Taiwan University of Science and Technology, and the Taiwan Breast Cancer Prevention Foundation collaborated to develop a breast cancer self-management support (BCSMS) mHealth app for Taiwanese women with breast cancer.
OBJECTIVE


The aim of this study was to investigate the quality of life (QoL) of women with breast cancer in Taiwan after using the BCSMS app.
METHODS


After receiving a first diagnosis of breast cancer, women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers, were randomized 1:1 into intervention and control groups. Intervention group subjects used the BCSMS app and the control group subjects received usual care. Two questionnaires-the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)-were distributed to subjects in both arms. Paper-based questionnaires were used at baseline; paper-based or Web-based questionnaires were used at 1.5-month and 3-month follow-up evaluations. All evaluations were self-assessed and anonymous, and participants were blinded to their allocation groups. Descriptive analysis, the Pearson chi-square test, analysis of variance, and the generalized estimating equation were used to analyze the data. Missing values, with and without multi-imputation techniques, were used for sensitivity analysis.
RESULTS


A total of 112 women were enrolled and randomly allocated to either the experimental group (n=53) or control group (n=59). The follow-up completion rate was 89.3% (100/112). The demographic data showed homogeneity between the two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments). The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months.
CONCLUSIONS


This research provides support for using a mobile health care app to promote the QoL among women in Taiwan after a first diagnosis of breast cancer. The BCSMS app could be used to support disease self-management, and further evaluation of whether QoL is sustained is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov NCT004174248; https://clinicaltrials.gov/ct2/show/NCT04174248.",2020,"The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months.
","['2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year', 'Taiwanese women with breast cancer', 'women with breast cancer in Taiwan after using the BCSMS app', 'of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan', 'A total of 112 women', 'women in Taiwan after a first diagnosis of breast cancer', 'women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers', 'two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments']",['BCSMS app and the control group subjects received usual care'],"['mean total QoL summary scores', 'Cancer (EORTC', 'QLQ-BR23', 'Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)-were', 'Quality of Life', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",112.0,0.062019,"The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months.
","[{'ForeName': 'I-Ching', 'Initials': 'IC', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Shan-Hsiang', 'Initials': 'SH', 'LastName': 'Shen', 'Affiliation': 'Department of Computer Science and Information Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.'}, {'ForeName': 'King-Jen', 'Initials': 'KJ', 'LastName': 'Chang', 'Affiliation': 'Taiwan Breast Cancer Foundation, Taipei, Taiwan.'}, {'ForeName': 'Hao-Chih', 'Initials': 'HC', 'LastName': 'Tai', 'Affiliation': 'Department of Surgery, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ay-Jen', 'Initials': 'AJ', 'LastName': 'Tsai', 'Affiliation': 'Taiwan Breast Cancer Foundation, Taipei, Taiwan.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""Center for Patient Safety Research and Practice, Brigham and Women's Hospital, Boston, MA, United States.""}]",JMIR mHealth and uHealth,['10.2196/17084']
468,31278414,Validity of bladder volume measurement by ultrasound in women postpartum.,"INTRODUCTION


Vaginal birth increases the risk of urinary retention and overdistention of the bladder. To avoid unnecessary discomfort by catheterization, it is preferable to use ultrasound for diagnosis of these conditions. The aim of this study was to determine the validity of transabdominal ultrasound and a portable ultrasound system, Biocon-700, to measure bladder volume in women postpartum.
METHODS


Fifty women were included in this method comparison study. Within 48 h of giving birth, their bladder volume was measured in randomized order with both transabdominal ultrasound and Biocon-700. After urination, participants were scanned with Biocon-700 to measure residual bladder volume, and finally the bladder was emptied by catheterization. The total bladder volume was calculated as the voided volume plus the catheterized volume.
RESULTS


Biocon-700 measured 43.4 ml ± 117.4 ml (mean ± SD) lower than the total bladder volume, while volumes measured by transabdominal ultrasound were 117.8 ml ± 110.0 ml (mean ± SD) lower. Linear regression showed significant proportional bias in both methods. The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
CONCLUSIONS


Neither transabdominal ultrasound nor the portable ultrasound system, Biocon-700, can be used to measure bladder volume precisely after vaginal delivery. However, both ultrasound methods can be used as screening tools to prevent overdistention of the bladder, and Biocon-700 can furthermore be used to screen women for a residual bladder volume > 150 ml.",2020,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","['Fifty women', 'women postpartum']","['transabdominal ultrasound and a portable ultrasound system, Biocon-700', 'transabdominal ultrasound and Biocon-700']",['total bladder volume'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume (observable entity)'}]",50.0,0.0404696,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","[{'ForeName': 'Josefine Tangen', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark. j.tangenjensen@gmail.com.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Klarskov', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jeannet', 'Initials': 'J', 'LastName': 'Lauenborg', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}]",International urogynecology journal,['10.1007/s00192-019-04037-1']
469,31743406,Instillation of 5% Povidone-Iodine Ophthalmic Drops Decreases the Respiratory Rate in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.,"PURPOSE


To investigate the effects of topical application of ophthalmic 5% povidone-iodine eye drops, which has been reported to cause apnea in spontaneously breathing children during general anesthesia.
METHODS


The authors conducted a randomized, controlled, single-blinded study comparing the effect of balanced salt solution eye drops and povidone-iodine eye drops on respiration in spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway. Fifty patients received balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops.
RESULTS


None of the control patients had a significant change in respiration. Thirty of the 50 (60%) povidone-iodine patients had a slowing of respiration within the first 6 breaths after eye drop instillation (P < .001). The median time of respiratory pause in those 30 patients was 18.5 seconds (range: 4.36 to 96.2 seconds). Among the povidone-iodine patients, children with a history of a prior tonsillectomy and adenoidectomy and/or bilateral myringotomy had a 7.2 times greater chance of experiencing a change in respiration after instillation of the povidone-iodine eye drops.
CONCLUSIONS


Topical application of 5% povidone-iodine eye drops causes a slowing and pause in spontaneous ventilation in a majority of children prior to strabismus surgery. This may represent activation of the diving reflex. [J Pediatr Ophthalmol Strabismus. 2019;56(6):378-382.].",2019,None of the control patients had a significant change in respiration.,"['Children Undergoing Strabismus Surgery', 'children prior to strabismus surgery', 'Fifty patients received', 'spontaneously breathing children during general anesthesia', 'patients, children with a history of a prior tonsillectomy and', 'spontaneously breathing children during general anesthesia with sevoflurane via a laryngeal mask airway']","['povidone-iodine eye drops', 'povidone-iodine', 'adenoidectomy and/or bilateral myringotomy', 'Povidone-Iodine Ophthalmic Drops', 'ophthalmic 5% povidone-iodine eye drops', 'balanced salt solution eye drops and povidone-iodine eye drops', 'balanced salt solution eye drops and 50 patients received 5% povidone-iodine eye drops']","['chance of experiencing a change in respiration', 'slowing of respiration', 'median time of respiratory pause', 'respiration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0087123', 'cui_str': 'Myringostomy'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",50.0,0.174816,None of the control patients had a significant change in respiration.,"[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rovner', 'Affiliation': ''}, {'ForeName': 'Bethany Jacobs', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Heine', 'Affiliation': ''}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Wester', 'Affiliation': ''}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Furse', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20190923-01']
470,32206987,"Effects of Xuezhitong in Patients with Hypertriglyceridemia: a Multicentre, Randomized, Double-Blind, Double Simulation, Positive Drug and Placebo Parallel Control Study.","BACKGROUD


Xuezhitong (XZT) is an extract of Allium macrostemon Bunge that has lipid-lowering properties.
OBJECTIVE


To evaluate the effects of XZT on lipids in subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia.
METHODS


A total of 358 subjects with HTG were enrolled and randomly assigned to receive XZT (2700 mg daily), xuezhikang (XZK) (1200 mg daily) or placebo. The primary endpoint was the reduction or percent reduction in the TG level over 12 weeks of treatment.
RESULTS


At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167). Treatment with XZT capsules also demonstrated superior performance compared with the placebo with respect to the control of lipids (17.97% vs 5.00%), total cholesterol (TC) (14.18% vs 3.89%), low-density lipoprotein cholesterol (LDL-C) (17.98% vs 2.95%), and high-density lipoprotein cholesterol (HDL-C) (21.47% vs 2.16%). Daily use of XZT for 12 weeks resulted in statistically significant (65.22% vs 38.30%, 25.00%; P < 0.0167) and clinically meaningful increases in HDL-C levels by ≥4 mg/dl compared with XZK and placebo. XZT was safe and well tolerated; the safety and tolerability profiles were similar across treatment groups. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase.
CONCLUSIONS


XZT significantly reduced TG levels and was well tolerated. Longer-term studies in more diverse patient populations are needed to corroborate these findings.
CLINICAL TRIAL REGISTRATION


www.chictr.org.cn Identifier: ChiCTR1900025854.",2020,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","['subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia', '358 subjects with HTG', 'Patients with Hypertriglyceridemia']","['Xuezhitong (XZT', 'placebo', 'XZK', 'Xuezhitong', 'XZT', 'xuezhikang (XZK', 'XZK and placebo']","['reduction or percent reduction in the TG level', 'tolerated', 'high-density lipoprotein cholesterol (HDL-C', 'safe and well tolerated; the safety and tolerability profiles', 'total cholesterol (TC', 'HDL-C levels', 'TG levels', 'TG level', 'superior performance', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",358.0,0.475119,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","[{'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Technology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': 'Beijing Compete Pharmaceutical Technology Development Co. LTD, Beijing, China.'}, {'ForeName': 'Junpin', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Harbin kansaisi Pharmaceutical Technology Development co. LTD, Harbin, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. linqian62@126.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06965-3']
471,32402609,Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.,"Cranial electrical stimulation (CES) is a noninvasive brain stimulation technique that has been shown to improve pain. However, few studies have investigated the potential benefits associated with remotely supervised CES in older adults with knee osteoarthritis (OA). The aim of this study was to examine the feasibility and preliminary efficacy of remotely supervised CES via secure videoconferencing software on clinical pain severity, experimental pain sensitivity, and pain-related cortical response in older adults with knee OA. Thirty participants with symptomatic knee OA pain were randomly assigned to receive 10 daily sessions (60 min each) of remotely supervised CES (n = 15) or sham CES (n = 15) over two weeks. We measured clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging. We also measured participant satisfaction with treatment using the Client Satisfaction Questionnaire. Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation. We also found significant changes in pain-related cortical hemodynamic activity after CES. Participants tolerated CES well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of remotely supervised CES for older adults with knee OA.",2020,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","['older adults with knee osteoarthritis (OA', 'older adults with knee OA', 'older adults with knee osteoarthritis', 'Thirty participants with symptomatic knee OA pain']","['Cranial electrical stimulation (CES', 'Active CES', 'remotely supervised CES (n\xa0=\xa015) or sham CES', 'remotely supervised CES via secure videoconferencing software', 'remotely supervised CES', 'remotely supervised cranial electrical stimulation']","['clinical pain severity, experimental pain sensitivity, and pain-related cortical response', 'pain-related cortical hemodynamic activity', 'Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation', 'clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging', 'Participants tolerated CES well without serious adverse effects', 'Feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.10685,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","[{'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Hyochol.Ahn@uth.tmc.edu.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Galle', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hsiao-Hui', 'Initials': 'HH', 'LastName': 'Ju', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCrackin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hargraves', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Jain', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dinh', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abdul-Mooti', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.05.003']
472,32405975,A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength.,"BACKGROUND


Residual neuromuscular blockade after surgery is associated with airway obstruction, hypoxia, and respiratory complications. Compared with neostigmine, sugammadex reverses neuromuscular blockade to a train-of-four ratio > 0.9 more rapidly. It is unknown, however, whether the superior reversal profile of sugammadex improves clinically relevant measures of strength in the early postoperative period.
METHODS


Patients undergoing general, gynecological, or urologic surgery were randomized to receive either neostigmine (70 µg·kg -1 , maximum 5 mg) or sugammadex (2 or 4 mg·kg -1 ) to reverse neuromuscular blockade. The primary outcome was the ability to breathe deeply measured by incentive spirometry at 30, 60, and 120 min after reversal.
RESULTS


We randomized 62 patients to either a neostigmine (n = 31) or sugammadex (n = 31) group. The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35). Median spirometry volumes at baseline, 30, 60, and 120 min postoperatively were 2650 vs 2500 mL, 1775 vs 1750 mL, 1375 vs 2000 mL, and 1800 vs 1950 mL for the sugammadex and neostigmine groups, respectively. Postoperative incentive spirometry decrease from baseline was not different between the two groups. Hand grip strength, the ability to sit unaided, train-of-four ratio on postanesthesia care unit (PACU) admission, time to extubation, time to PACU discharge readiness, and Quality of Recovery-15 scores were also not different between the groups.
CONCLUSIONS


Measures of postoperative strength, such as incentive spirometry, hand group strength, and the ability to sit up in the early postoperative period were not different in patients who received neostigmine or sugammadex for the reversal of neuromuscular blockade.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02909439); registered: 21 September, 2016.",2020,The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35).,"['Patients undergoing general, gynecological, or urologic surgery']","['sugammadex', 'neostigmine, sugammadex', 'neostigmine or sugammadex', 'neostigmine', 'neostigmine (70 µg·kg -1 , maximum 5 mg) or sugammadex (2 or 4 mg·kg -1 ) to reverse neuromuscular blockade']","['Median spirometry volumes', 'Hand grip strength, the ability to sit unaided, train-of-four ratio on postanesthesia care unit (PACU) admission, time to extubation, time to PACU discharge readiness, and Quality of Recovery-15 scores', 'early postoperative strength', 'Postoperative incentive spirometry decrease', 'incentive spirometry volume recovery trajectory', 'ability to breathe deeply measured by incentive spirometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0038913', 'cui_str': 'Procedure, Urologic Surgical'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0560879', 'cui_str': 'Ability to sit'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0566501', 'cui_str': 'Ability to breathe'}, {'cui': 'C4554317', 'cui_str': 'Deeply'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",62.0,0.373182,The incentive spirometry volume recovery trajectory was not different between the two groups (P = 0.35).,"[{'ForeName': 'Ramon E', 'Initials': 'RE', 'LastName': 'Abola', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA. Ramon.abola@stonybrookmedicine.edu.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Romeiser', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Rizwan', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lung', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Bennett-Guerrero', 'Affiliation': 'Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY, 11794, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01695-4']
473,30192907,Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps.,"BACKGROUND


HeartSteps is an mHealth intervention that encourages regular walking via activity suggestions tailored to the individuals' current context.
PURPOSE


We conducted a micro-randomized trial (MRT) to evaluate the efficacy of HeartSteps' activity suggestions to optimize the intervention.
METHODS


We conducted a 6-week MRT with 44 adults. Contextually tailored suggestions could be delivered up to five times per day at user-selected times. At each of these five times, for each participant on each day of the study, HeartSteps randomized whether to provide an activity suggestion, and, if so, whether to provide a walking or an antisedentary suggestion. We used a centered and weighted least squares method to analyze the effect of suggestions on the 30-min step count following suggestion randomization.
RESULTS


Averaging over study days and types of activity suggestions, delivering a suggestion versus no suggestion increased the 30-min step count by 14% (p = .06), 35 additional steps over the 253-step average. The effect was not evenly distributed in time. Providing any type of suggestion versus no suggestion initially increased the step count by 66% (167 steps; p < .01), but this effect diminished over time. Averaging over study days, delivering a walking suggestion versus no suggestion increased the average step count by 24% (59 steps; p = .02). This increase was greater at the start of study (107% or 271 additional steps; p < .01), but decreased over time. Antisedentary suggestions had no detectable effect on the 30-min step count.
CONCLUSION


Contextually tailored walking suggestions are a promising way of initiating bouts of walking throughout the day.
CLINICAL TRIAL INFORMATION


This study was registered on ClinicalTrials.gov number NCT03225521.",2019,"This increase was greater at the start of study (107% or 271 additional steps; p < .01), but decreased over time.","['44 adults', 'Physical Activity']",[],['average step count'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],"[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0488282,"This increase was greater at the start of study (107% or 271 additional steps; p < .01), but decreased over time.","[{'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Minor Ave, Suite, Seattle, WA, USA.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Insitute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Seewald', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'School of Information, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Brook', 'Initials': 'B', 'LastName': 'Luers', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Hekler', 'Affiliation': 'School of Medicine, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay067']
474,31679747,A Walking Intervention to Increase Weekly Steps in Dialysis Patients: A Pilot Randomized Controlled Trial.,"RATIONALE & OBJECTIVE


Patients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk.
STUDY DESIGN


Pilot randomized controlled trial.
SETTING & PARTICIPANTS


60 dialysis patients from San Francisco dialysis clinics.
INTERVENTION


Participants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months.
OUTCOMES


The primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%.
RESULTS


49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n=30) increased their average daily steps by 2,256 (95% CI, 978-3,537) more than the 30 controls (P<0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up.
LIMITATIONS


The Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity.
CONCLUSIONS


A short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms.
FUNDING


Supported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study identifier NCT02623348.",2020,"Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05).","['Patients receiving dialysis report very low physical activity', 'Dialysis Patients', '60 dialysis patients from San Francisco dialysis clinics']","['receiving pedometers with weekly step goals or usual care for 3 months', 'Walking Intervention', 'pedometer-based intervention']","['physical activity, symptoms, and surrogates of cardiovascular risk', 'physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk', 'symptoms, physical performance, or endothelial function', 'Heart rate variability (standard deviation of N-N intervals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.118622,"Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05).","[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Sheshadri', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA. Electronic address: anoop.sheshadri@ucsf.edu.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Division of Internal Medicine-Nephrology, Chulalongkorn University, Bangkok, Thailand; Special Task Force for Activating Research in Renal Nutrition, (Renal Nutrition Research Group), Office of Research Affairs, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.07.026']
475,32205572,Acute pain after serratus anterior plane or thoracic paravertebral blocks for video-assisted thoracoscopic surgery: A randomised trial.,"BACKGROUND


Serratus anterior and paravertebral blocks can both be used for video-assisted thoracic surgery. However, serratus anterior blocks are easier to perform, and possibly safer. We therefore tested the primary hypothesis that serratus anterior plane blocks and thoracic paravertebral blocks provide comparable analgesia for video-assisted thoracic surgery. Secondarily, we tested the hypothesis that both blocks lengthen the time to onset of surgical pain and reduce the need for rescue tramadol.
METHODS


Patients having video-assisted thoracic lobectomy or segmentectomy were randomly allocated to ultrasound-guided thoracic paravertebral blocks, n = 30; ultrasound-guided serratus anterior plane blocks, n = 30; or, general anaesthesia alone, n = 30. Visual analogue pain scores analogue pain scores at rest, during coughing and Prince-Henry pain scores were used to assess postoperative analgesia. Our primary analysis was noninferiority of serratus anterior blocks compared with paravertebral blocks.
RESULTS


Baseline characteristics were comparable among the three groups. Two hours after surgery, the mean difference in visual analogue pain scores between the serratus anterior and paravertebral blocks was 0.0 (96.8% CI -0.4 to 0.3) cm at rest, -0.2 (-0.8 to 0.4) cm during coughing and -0.1(-0.5 to 0.3) for Prince-Henry pain scores. After 24 h, the mean difference was 0.0 (-0.7 to 0.8) cm at rest, 0.1 (-0.8 to 0.9) cm during coughing and 0.1(-0.4 to 0.6) for Prince-Henry pain scores. All differences were significantly noninferior. Time to onset of pain after surgery was 19 ± 5 (SD) hours with serratus anterior blocks, 16 ± 5 h with paravertebral blocks and 12 ± 5 h with general anaesthesia. Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone. Patients with serratus anterior block had a significantly lower incidence of intra-operative hypotension and requirement for intra-operative vasopressor (3.4%), compared with general anaesthesia alone. Serratus anterior block took less time to perform than paravertebral block (5.1 ± 1.1 min versus 10.1 ± 2.9 min).
CONCLUSION


Serratus anterior plane blocks, which are easier and quicker than paravertebral blocks, provide comparable analgesia in patients having video-assisted thoracic surgery.
CLINICAL TRIAL NUMBER AND REGISTRY URL


ChiCTR1800017671; http://www.chictr.org.cn/hvshowproject.aspx?id=13510.",2020,"Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone.","['patients having video-assisted thoracic surgery', 'Patients having video-assisted thoracic lobectomy or segmentectomy']","['video-assisted thoracic surgery', 'serratus anterior plane or thoracic paravertebral blocks', 'ultrasound-guided thoracic paravertebral blocks, n\u200a=\u200a30; ultrasound-guided serratus anterior plane blocks, n\u200a=\u200a30; or, general anaesthesia alone, n\u200a=\u200a30', 'video-assisted thoracoscopic surgery', 'sufentanil']","['postoperative rescue analgesia (tramadol', 'visual analogue pain scores', 'Acute pain', 'Visual analogue visual analogue pain scores at rest, during coughing and Prince-Henry pain scores', 'postoperative nausea and vomiting', 'incidence of intra-operative hypotension and requirement for intra-operative vasopressor']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}]","[{'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0582517', 'cui_str': 'henry (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.144153,"Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone.","[{'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China (YQ, JW, QH, YL, MX); Department of Outcomes Research, Anesthesiology Institute (YQ, DY, II, DIS); Outcomes Research Consortium (JW); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA (DY); Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey (II).'}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yungang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001196']
476,32068975,"A program of exercise, brain training, and lecture to prevent cognitive decline.","OBJECTIVE


We examined the benefits of a community-based program combining physical exercise, cognitive training, and education on dementia and lifestyle habits.
METHODS


This crossover open-label trial included 141 community-dwelling elderly people with suspected mild cognitive decline (MCD). Subjects were assigned to a 6-month intervention-first/6-month observation-second (INT-OBS) group or an OBS-INT group. The 6-month intervention consisted of 2 h of physical exercise, cognitive training, and classroom study or rest once weekly. Primary outcome was change in Touch Panel-type Dementia Assessment Scale (TDAS) score.
RESULTS


TDAS score improved significantly during the intervention period compared with the observation period for all subjects (P < 0.05). Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05).
INTERPRETATION


This community-based program improved both cognitive and physical function in elderly people with suspected MCD.",2020,"Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05).
","['141 community-dwelling elderly people with suspected mild cognitive decline (MCD', 'elderly people with suspected MCD']","['exercise, brain training, and lecture', '6-month intervention-first/6-month observation-second (INT-OBS) group or an OBS-INT group', 'community-based program combining physical exercise, cognitive training, and education', '2\xa0h of physical exercise, cognitive training, and classroom study or rest once weekly']","['TDAS score', 'change in Touch Panel-type Dementia Assessment Scale (TDAS) score']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",141.0,0.0220147,"Some physical functions also improved significantly during the intervention period compared with the observation period in the OBS-INT group (P < 0.05).
","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kouzuki', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86, Nishi-cho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Division of Medical Science in Sports and Exercise, Department of Social Medicine, Faculty of Medicine, Tottori University, 4-101 Koyama-cho Minami, Tottori, 680-8550, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Wada-Isoe', 'Affiliation': 'Division of Neurology, Department of Brain and Neurological Sciences, Faculty of Medicine, Tottori University, 36-1, Nichi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Department of Clinical Psychology, Tottori University Graduate School of Medical Sciences, 86, Nishi-cho, Yonago, 683-8503, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Tamura', 'Affiliation': 'The Nanbu Town National Health Insurance Saihaku Hospital, 397, Yamato, Nanbu-cho, Saihaku, 683-0323, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takanashi', 'Affiliation': 'Department of Occupational Therapist, YMCA College of Medical & Human Services in Yonago, 3-3-2, Kinkai-cho, Yonago, Tottori, 683-0825, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Azumi', 'Affiliation': 'Department of Rehabilitation, Satoni Den-en Clinic, 54-2, Satoni, Tottori-shi, Tottori, 680-0935, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Social Welfare Corporation Kohen, Nursing home Sakaikohen, 2083, Seido-cho, Sakaiminato, 684-0063, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Maruyama', 'Affiliation': 'Kotoura Town Hall, 591-2, Tokuman, Kotoura-cho, Touhakugunn, 689-2392, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Kotoura Town Hall, 591-2, Tokuman, Kotoura-cho, Touhakugunn, 689-2392, Japan.'}, {'ForeName': 'Michimi', 'Initials': 'M', 'LastName': 'Itou', 'Affiliation': 'Yonago Public Comprehensive Support Center for Shoutoku-Community, 1238 Ishii, Yonago, Tottori, 683-0021, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Urakami', 'Affiliation': 'Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University, 86, Nishi-cho, Yonago, 683-8503, Japan.'}]",Annals of clinical and translational neurology,['10.1002/acn3.50993']
477,32199559,Teaching older drivers to navigate GPS technology.,"BACKGROUND AND OBJECTIVES


New technologies are being implemented in motor vehicles. One key technology is the electronic navigation system (ENS) that assists the driver in wayfinding, or actually guides the vehicle in higher level automation vehicles. It is unclear how older adults interact with ENSs and the best approach to train older adults to use the devices. The objectives of this study were to explore how older drivers interacted with an ENS while driving on live roadways and how various training approaches impacted older drivers' ability to accurately enter destinations into the ENS.
RESEARCH DESIGN AND METHODS


In Experiment 1, 80 older drivers navigated unfamiliar routes using an ENS or paper directions and completed a series of ENS destination entry tasks. In Experiment 2, 60 older drivers completed one of three training conditions (ENS video only, ENS video with hands-on training, placebo) to examine the impacts of training on destination entry performance.
RESULTS AND DISCUSSION


Driving performance was aided by the use of the ENS, but many older drivers had difficulty entering destinations into the device (Experiment 1). The combined video with hands-on ENS training resulted in the best overall destination entry performance (Experiment 2). Practical applications: The results suggest older drivers may experience problems entering destinations into ENSs, but training can improve performance. These performance issues may be especially important as more vehicle features require interaction with computer systems to select destinations or other automation related features. Further research is needed to determine how to prepare the next generation of older drivers who will interact with technologies aimed at increasing mobility.",2020,"RESULTS AND DISCUSSION


Driving performance was aided by the use of the ENS, but many older drivers had difficulty entering destinations into the device (Experiment 1).","['80 older drivers navigated unfamiliar routes using an ENS or paper directions and completed a series of ENS destination entry tasks', '60 older drivers', 'Teaching older drivers to navigate GPS technology']","['training conditions (ENS video only, ENS video with hands-on training, placebo', 'combined video with hands-on ENS training']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],,0.0185249,"RESULTS AND DISCUSSION


Driving performance was aided by the use of the ENS, but many older drivers had difficulty entering destinations into the device (Experiment 1).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dennis Thomas', 'Affiliation': 'Dunlap and Associates, Inc., Stamford, CT, USA. Electronic address: FDennisThomas@aol.com.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Dickerson', 'Affiliation': 'East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Graham', 'Affiliation': 'Dunlap and Associates, Inc., Stamford, CT, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chandler Coleman', 'Affiliation': 'East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Kraig A', 'Initials': 'KA', 'LastName': 'Finstad', 'Affiliation': 'Independent Consultant, Saint Augustine, FL, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Blomberg', 'Affiliation': 'Dunlap and Associates, Inc., Stamford, CT, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wright', 'Affiliation': 'Dunlap and Associates, Inc., Stamford, CT, USA.'}]",Journal of safety research,['10.1016/j.jsr.2019.12.001']
478,32209619,Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.,"OBJECTIVES


The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.
DESIGN


In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.
SETTING


This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.
PARTICIPANTS


368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.
INTERVENTIONS


NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.
RESULTS


In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.
CONCLUSIONS


NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.
TRIAL REGISTRATION NUMBERS


NCT01480362 and DRKS00003347.",2020,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","['191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes', 'Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included', '40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care', '96 participants in the NPWT arm and 72 participants in the', 'patients with diabetic foot wounds in clinical practice', '368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population']","['standard moist wound care', 'Negative pressure wound therapy', 'NPWT', 'SMWC', 'negative pressure wound therapy (NPWT', 'NPWT was compared with standard moist wound care (SMWC']","['wound closure rate', 'wound closure within 16 weeks', 'Overall, wound closure rate', 'wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months', 'diabetic foot ulcers', 'time to wound closure']","[{'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]",368.0,0.180456,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","[{'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Seidel', 'Affiliation': 'Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Köln, Germany Doerthe.Seidel@uni-wh.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Storck', 'Affiliation': 'Klinik für Gefäß- und Thoraxchirurgie, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Praxis für Herzkreislauferkrankungen, Ettlingen, Germany.'}, {'ForeName': 'Gernold', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Gefäßchirurgische Klinik, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mauckner', 'Affiliation': 'Innere Medizin, St. Remigius Krankenhaus Opladen, Leverkusen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hochlenert', 'Affiliation': 'Gemeinschaftspraxis Schlotmann-Hochlenert-Zavaleta-Haberstock, Köln, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wetzel-Roth', 'Affiliation': 'Chirurgische Praxis Wetzel-Roth, Buchloe, Germany.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Sondern', 'Affiliation': 'Klinik für Innere Medizin/Diabetologie, Marien Hospital Dortmund-Hombruch, Dortmund, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Allgemein- und Viszeralchirurgie, Helfenstein Klinik, Geisslingen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Rothenaicher', 'Affiliation': 'Chirurgische Praxis Rothenaicher, München, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krönert', 'Affiliation': 'Klinik für Gefäßchirurgie, Thüringen-Kliniken ""Georgius Agricola"" GmbH, Saalfeld, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zink', 'Affiliation': 'Diabetes Klinik, Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Neugebauer', 'Affiliation': 'Department fur Humanmedizin, Universität Witten/Herdecke, Witten, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-026345']
479,32209621,Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial.,"BACKGROUND


Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.
METHODS AND ANALYSES


In this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention 'StudiCare Mindfulness' will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


All study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


DRKS00014701.",2020,"The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia.","['120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm', 'university students experience higher', 'university students']","['guided online mindfulness-focused intervention', ""guided version of the online mindfulness-focused intervention 'StudiCare Mindfulness""]","['depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia', 'Sociodemographic variables, treatment expectations, side and adverse side effects', 'psychological stress']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",120.0,0.13543,"The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Schultchen', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany dana.schultchen@uni-ulm.de.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Küchler', 'Affiliation': 'Department of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schillings', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Weineck', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karabatsiakis', 'Affiliation': 'Clinical Psychology, University of Innsbruck, Innsbruck, Tyrol, Austria.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pollatos', 'Affiliation': 'Department of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032775']
480,32406312,High Salt Intake Augments Blood Pressure Responses During Submaximal Aerobic Exercise.,"Background High sodium (Na + ) intake is a widespread cardiovascular disease risk factor. High Na +  intake impairs endothelial function and exaggerates sympathetic reflexes, which may augment exercising blood pressure (BP) responses. Therefore, this study examined the influence of high dietary Na +  on BP responses during submaximal aerobic exercise. Methods and Results Twenty adults (8F/12M, age=24±4 years; body mass index 23.0±0.6 kg·m -2 ; VO 2 peak=39.7±9.8 mL·min -1 ·kg -1 ; systolic BP=111±10 mm Hg; diastolic BP=64±8 mm Hg) participated in this randomized, double-blind, placebo-controlled crossover study. Total Na +  intake was manipulated via ingestion of capsules containing either a placebo (dextrose) or table salt (3900 mg Na + /day) for 10 days each, separated by ≥2 weeks. On day 10 of each intervention, endothelial function was assessed via flow-mediated dilation followed by BP measurement at rest and during 50 minutes of cycling at 60% VO 2peak . Throughout exercise, BP was assessed continuously via finger photoplethysmography and every 5 minutes via auscultation. Venous blood samples were collected at rest and during the final 10 minutes of exercise for assessment of norepinephrine. High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001). Average exercising systolic BP was augmented following high Na +  (placebo=Δ30.0±16.3 versus Na + =Δ38.3±16.2 mm Hg;  P =0.03) and correlated to the reduction in flow-mediated dilation ( R =-0.71,  P =0.002). Resting norepinephrine concentration was not different between conditions ( P =0.82). Norepinephrine increased during exercise ( P =0.002), but there was no Na +  effect ( P =0.26). Conclusions High dietary Na +  augments BP responses during submaximal aerobic exercise, which may be mediated, in part, by impaired endothelial function.",2020,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"['Hg; diastolic BP=64±8\xa0mm\xa0Hg', 'Twenty adults (8F/12M']","[' High sodium (Na + ) intake', 'Norepinephrine', 'High Na +  intake', 'placebo (dextrose) or table salt (3900', 'High Salt Intake', 'high dietary Na ', 'placebo']","['BP responses', 'endothelial function', 'endothelial function and exaggerates sympathetic reflexes', 'Venous blood samples', 'reduction in flow-mediated dilation', 'exercising blood pressure (BP) responses', 'urinary Na +  excretion', 'Resting norepinephrine concentration', 'Average exercising systolic BP', 'reduced flow-mediated dilation']","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206136', 'cui_str': 'Dietary Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.259216,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology University of Connecticut Storrs CT.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015633']
481,32401589,Re: Randomised Clinical Trial of Prostate Artery Embolisation versus a Sham Procedure for Benign Prostatic Hyperplasia.,,2020,,['Benign Prostatic Hyperplasia'],['Prostate Artery Embolisation'],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",[],,0.264533,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100']
482,32401590,Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate: Subgroup Analysis from a Blinded Randomized Trial.,,2020,,[],['Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate'],[],[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0278106', 'cui_str': 'Anejaculation'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]",[],,0.247962,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100.01']
483,32199866,Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials.,"PURPOSE


To assess visual function outcomes to 48 weeks in patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration included in 2 interventional clinical trials: relationship to baseline lesion size, outcomes by baseline lesion characteristic subgroups, and correlation of visual function outcomes with GA area.
DESIGN


The Chroma and Spectri studies (ClinicalTrials.gov identifiers, NCT02247479 and NCT02247531, respectively) were identically designed phase 3, double-masked, multicenter, randomized, sham injection-controlled clinical trials that evaluated intravitreal lampalizumab in GA.
PARTICIPANTS


Eligible patients were 50 years of age or older with well-demarcated bilateral GA (lesion size, 1-7 disc areas) without evidence of or previous treatment for choroidal neovascularization in either eye and best-corrected visual acuity (BCVA) letter score of 49 letters or more (≥1 GA lesion within 250 μm of foveal center if BCVA ≥79 letters).
METHODS


Patients (pooled n = 1881) were randomized 2:1:2:1 to lampalizumab every 4 weeks, sham every 4 weeks, lampalizumab every 6 weeks, or sham every 6 weeks. Sham arms were pooled for analysis.
MAIN OUTCOME MEASURES


Functional end points included change in BCVA from baseline to week 48, low-luminance visual acuity, mesopic microperimetry (number of absolute scotomatous points, mean macular sensitivity), binocular and monocular maximum reading speed, and 2 validated patient-reported outcome measures: Functional Reading Independence Index and 25-item National Eye Institute Visual Function Questionnaire.
RESULTS


Enlargement of GA area, approximately 2 mm 2 /year on average across all treatment groups in each study, was accompanied by overall deterioration in all functional end points. No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores. Of visual function tests, only microperimetry outcomes were correlated moderately with GA lesion area when assessed cross-sectionally at baseline and week 48.
CONCLUSIONS


Chroma and Spectri provide a unique data set of functional end points in GA that are relevant for future clinical trials. Patients with bilateral GA experienced a consistent decline in visual function over 48 weeks, but measures of visual function were not correlated strongly with GA lesion area. It is not possible to predict visual function outcomes from GA lesion size.",2020,No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores.,"['Eligible patients were 50 years of age or older with well-demarcated bilateral GA (lesion size, 1-7 disc areas) without evidence of or previous treatment for choroidal neovascularization in either eye and best-corrected visual acuity (BCVA) letter score of 49 letters or more (≥1 GA lesion within 250 μm of foveal center if BCVA ≥79 letters', 'patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration included in 2 interventional clinical trials', 'Patients (pooled n\xa0= 1881', 'Geographic Atrophy']",['lampalizumab'],"['visual function outcomes', 'visual function', 'functional assessment scores', 'Visual Function Decline', 'low-luminance visual acuity, mesopic microperimetry (number of absolute scotomatous points, mean macular sensitivity), binocular and monocular maximum reading speed, and 2 validated patient-reported outcome measures: Functional Reading Independence Index and 25-item National Eye Institute Visual Function Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}]","[{'cui': 'C4054668', 'cui_str': 'lampalizumab'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1881.0,0.636261,No statistically significant differences were found between lampalizumab or sham arms for changes from baseline in functional assessment scores.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara, California.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Centre for Public Health, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'Ophthalmology Specialists of Texas, PLLC, and Integrated Clinical Research, LLC, Abilene, Texas.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Retina Specialty Institute, Pensacola, Florida.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lotery', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Eleonora M', 'Initials': 'EM', 'LastName': 'Lad', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Silverman', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Henry', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Anderesi', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tschosik', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ferrara', 'Affiliation': 'Genentech, Inc., South San Francisco, California. Electronic address: ferrara.daniela@gene.com.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Department of Surgery, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.01.019']
484,31391203,Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).,"OBJECTIVE


GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort.
RESEARCH DESIGN AND METHODS


Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine.
RESULTS


At baseline, GRADE's 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA 1c  of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m 2 , and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease).
CONCLUSIONS


The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.",2019,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","['Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed', 'requiring a second diabetes medication', '5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino', 'people with type 2 diabetes (T2DM', 'GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort', 'Diabetes', 'NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease']","['metformin monotherapy', 'metformin', 'glimepiride, sitagliptin, liraglutide, or insulin glargine']","['history of hypertension', 'history of heart attack or stroke']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",69.0,0.0711735,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA grademail@bsc.gwu.edu.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, MD.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Hermes J', 'Initials': 'HJ', 'LastName': 'Florez', 'Affiliation': 'University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hox', 'Affiliation': 'Pacific Health Research & Education Institute, Honolulu, HI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Underkofler', 'Affiliation': 'University of Colorado, Denver, Denver, CO.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0901']
485,32403062,"The effect of viewing challenging ""reality check"" Instagram comments on women's body image.","One increasing trend on social media is the posting of challenging or ""reality check"" comments about idealized photos of thin and attractive women. The aim of the present study was to experimentally investigate the effect of viewing such reality check comments after a positive appearance comment on young women's body image. Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment. In contrast to prediction, viewing positive appearance comments did not elicit more body dissatisfaction than viewing images with no comments. As predicted, however, adding a reality check comment did reduce body dissatisfaction relative to the positive appearance comment alone. It was concluded that making and viewing reality check comments provides a potential way for women to mitigate some of the negative effect of Instagram imagery.",2020,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[""young women's body image"", 'Participants were 192 women aged 17-25 years', ""women's body image""]","['view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment', 'viewing challenging ""reality check"" Instagram comments']",['body dissatisfaction'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",192.0,0.0251286,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Vasiliki Georgia', 'Initials': 'VG', 'LastName': 'Velissaris', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}]",Body image,['10.1016/j.bodyim.2020.04.004']
486,32403066,A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors.,"OBJECTIVE


To assess the efficacy of aerobic exercise training to improve controlled attention, information processing speed and neural communication during increasing task load and rest in pediatric brain tumor survivors (PBTS) treated with cranial radiation.
METHODS


Participants completed visual-motor Go and Go/No-Go tasks during magnetoencephalography recording prior to and following the completion of 12-weeks of exercise training. Exercise-related changes in response accuracy and visual-motor latency were evaluated with Linear Mixed models. The Phase Lag Index (PLI) was used to estimate functional connectivity during task performance and rest. Changes in PLI values after exercise training were assessed using Partial Least Squares analysis.
RESULTS


Exercise training predicted sustained (12-weeks) improvement in response accuracy (p<0.05) during No-Go trials. Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials. Significant changes in response latency and resting state connectivity were not detected.
CONCLUSION


These findings support the efficacy of aerobic exercise to improve controlled attention and enhance functional mechanisms under increasing task load in participants.
SIGNIFICANCE


It may be possible to harness the beneficial effects of exercise as therapy to promote cognitive recovery and enhance brain function in PBTS.",2020,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"['pediatric brain tumor survivors (PBTS) treated with cranial radiation', 'Participants completed visual-motor Go and Go', 'pediatric brain tumor survivors']","['exercise training', 'aerobic exercise', 'Exercise training', 'aerobic exercise training']","['PLI values', 'Phase Lag Index (PLI', 'cognition and neural communication', 'response accuracy and visual-motor latency', 'response accuracy', 'Altered functional connectivity', 'response latency and resting state connectivity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0354978,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: harasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.027']
487,32118508,Phonophoretic application of a glucosamine and chondroitin nanoemulsion for treatment of knee chondropathies.,"Aim:  This study was performed to assess the effect of the phonophoretic application of a nanoemulsion incorporating glucosamine and chondroitin sulfate (NANO-CG) associated with kinesiotherapy on the reduction of pain and stiffness in knee chondropathy.  Materials & methods:  NANO-CG was tested  in vitro  and  in vivo  prior to being applied in a randomized and controlled clinical trial.  Results:  Cell viability and hen's egg test-chorionallantonic membrane tests indicated the NANO-CG is safe for topical application. Permeation tests showed NANO-CG enhances drug permeation through the skin. There was no statistical significance between treated groups in this preliminary study, however, pain reduction and complete recovery of articular cartilage were observed in some patients treated with NANO-CG.  Conclusion:  We demonstrate that NANO-CG may be a promising candidate for the therapy of knee chondropathy.",2020,"There was no statistical significance between treated groups in this preliminary study, however, pain reduction and complete recovery of articular cartilage were observed in some patients treated with NANO-CG.  ",['knee chondropathies'],"['glucosamine and chondroitin sulfate (NANO-CG', 'glucosamine and chondroitin nanoemulsion', 'NANO-CG', 'kinesiotherapy']","['pain and stiffness', 'pain reduction and complete recovery of articular cartilage']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0007302', 'cui_str': 'Cartilage Diseases'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0008454', 'cui_str': 'Chondroitin'}, {'cui': 'C1096702', 'cui_str': 'Kinesiotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}]",,0.0177916,"There was no statistical significance between treated groups in this preliminary study, however, pain reduction and complete recovery of articular cartilage were observed in some patients treated with NANO-CG.  ","[{'ForeName': 'Cláudia Bs', 'Initials': 'CB', 'LastName': 'Leite', 'Affiliation': 'Green Nanotechnology Group, Faculty of Ceilandia, University of Brasilia, Brasilia, DF 72220-900, Brazil.'}, {'ForeName': 'Janaina M', 'Initials': 'JM', 'LastName': 'Coelho', 'Affiliation': 'Laboratory of Nanoscience & Immunology, Faculty of Ceilandia, University of Brasilia, Brasilia, DF 72220-900, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ferreira-Nunes', 'Affiliation': 'Laboratory of Food, Drugs & Cosmetics (LTMAC), University of Brasilia, Brasilia, DF, 70910-900, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Gelfuso', 'Affiliation': 'Laboratory of Food, Drugs & Cosmetics (LTMAC), University of Brasilia, Brasilia, DF, 70910-900, Brazil.'}, {'ForeName': 'João Lq', 'Initials': 'JL', 'LastName': 'Durigan', 'Affiliation': 'Rehabilitation Sciences Graduation Program, University of Brasilia, Brasilia, DF 72220-900, Brazil.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Azevedo', 'Affiliation': 'Department of Genetics & Morphology, Institute of Biological Sciences, University of Brasilia, Brasilia, DF 70910-900, Brazil.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Muehlmann', 'Affiliation': 'Laboratory of Nanoscience & Immunology, Faculty of Ceilandia, University of Brasilia, Brasilia, DF 72220-900, Brazil.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Sousa', 'Affiliation': 'Green Nanotechnology Group, Faculty of Ceilandia, University of Brasilia, Brasilia, DF 72220-900, Brazil.'}]","Nanomedicine (London, England)",['10.2217/nnm-2019-0317']
488,32406111,Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal.,"CRADLE was a 36-month multicenter study in pediatric (≥1 to <18 years) kidney transplant recipients randomized at 4 to 6 weeks posttransplant to receive everolimus + reduced-exposure tacrolimus (EVR + rTAC; n = 52) with corticosteroid withdrawal at 6-month posttransplant or continue mycophenolate mofetil + standard-exposure TAC (MMF + sTAC; n = 54) with corticosteroids. The incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death) at month 36 was 9.8% vs 9.6% (difference: 0.2%; 80% confidence interval: -7.3 to 7.7) for EVR + rTAC and MMF + sTAC, respectively, which was driven by BPARs. Graft loss was low (2.1% vs 3.8%) with no deaths. Mean estimated glomerular filtration rate at month 36 was comparable between groups (68.1 vs 67.3 mL/min/1.73 m 2  ). Mean changes (z-score) in height (0.72 vs 0.39; P = .158) and weight (0.61 vs 0.82; P = .453) from randomization to month 36 were comparable, whereas growth in prepubertal patients on EVR + rTAC was better (P = .050) vs MMF + sTAC. The overall incidence of adverse events (AEs) and serious AEs was comparable between groups. Rejection was the leading AE for study drug discontinuation in the EVR + rTAC group. In conclusion, though AE-related study drug discontinuation was higher, an EVR + rTAC regimen represents an alternative treatment option that enables withdrawal of steroids as well as reduction of CNIs for pediatric kidney transplant recipients. ClinicalTrials.gov: NCT01544491.",2020,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","['pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal', 'pediatric (≥1 to <18 years) kidney transplant recipients randomized at']",['4-6 weeks post-transplantation to receive everolimus+reduced-exposure tacrolimus (EVR+rTAC; N=52) with corticosteriod withdrawal at 6-month post-transplantation or continue mycophenolate mofetil+standard-exposure TAC (MMF+sTAC; N=54) with corticosteroids'],"['incidence of composite efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, or death', 'weight', 'Mean estimated glomerular filtration rate', 'overall incidence of adverse events (AEs) and serious AEs', 'Graft loss']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0550015,"Mean changes (z-score) in height (0.72 vs 0.39; P=0.158) and weight (0.61 vs 0.82; P=0.453) from randomization to Month 36 were comparable, while growth in pre-pubertal patients on EVR+rTAC was better (P=0.050) versus MMF+sTAC.","[{'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Nephrology Division, Hospital do Rim, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ettenger', 'Affiliation': ""Division of Pediatric Nephrology, UCLA Mattel Children's Hospital, Los Angeles, California, USA.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': ""Department of Pediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjerre', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Department of Pediatrics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dello Strologo', 'Affiliation': ""Nephrology Unit, Department of Pediatrics, Institute for Scientific Research, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Marks', 'Affiliation': 'Department of Pediatric Nephrology, Great Ormond Street Hospital for Children, NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Nephrology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Udaykiran', 'Initials': 'U', 'LastName': 'Veldandi', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cousin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16005']
489,32163509,Trauma-affected refugees treated with basic body awareness therapy or mixed physical activity as augmentation to treatment as usual-A pragmatic randomised controlled trial.,"BACKGROUND


The prevalence of post-traumatic stress disorder (PTSD) is estimated to be as high as 30% among refugees. The coexistence of prevalent chronic pain is believed to maintain symptoms of PTSD and add complexity to the condition. Despite this, little evidence exists on how to treat PTSD and comorbid conditions best in trauma-affected refugees.
AIM


The aim of the present study was to investigate if adding either BBAT or mixed physical activity to the treatment as usual (TAU) for trauma-affected refugees with PTSD would increase the treatment effect compared to TAU alone.
METHOD


Randomised controlled trial, 3-armed parallel group superiority study, conducted at Competence Centre for Transcultural Psychiatry, Denmark. Participants were adult trauma-affected refugees with PTSD. Allocation ratio was 1:1:1, stratified for PTSD severity and gender. An open-label design was applied due to the nature of the intervention. Participants were randomised to receive either individual basic body awareness therapy (group B) or individual mixed physical activity (group M) one hour/week for 20 weeks plus TAU, or TAU only (group C). The primary outcome was PTSD severity measured by Harvard Trauma Questionnaire (HTQ). Trial registration: ClinicalTrials.gov, NCT01955538.
RESULTS


Of the 338 patients included (C/B/M = 110/114/114), 318 patients were eligible for intention-to-treat analysis (C/B/M = 104/105/109). On the primary outcome, intention-to-treat as well as per-protocol analyses showed small but significant improvement on scores from pre- to post-treatment in all three groups but with no significant difference in improvement between groups.
CONCLUSIONS


The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees. There is a need for studies on potential subpopulations of trauma-affected refugees who could benefit from physical activity as a part of their treatment.",2020,"The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees.","['Participants were adult trauma-affected refugees with PTSD', 'conducted at Competence Centre for Transcultural Psychiatry, Denmark', '338 patients included (C/B/M = 110/114/114', '318 patients were eligible for intention-to-treat analysis (C/B/M = 104/105/109']","['individual basic body awareness therapy (group B) or individual mixed physical activity (group M) one hour/week for 20 weeks plus TAU, or TAU', 'basic body awareness therapy or mixed physical activity', 'BBAT']","['intention-to-treat', 'PTSD severity measured by Harvard Trauma Questionnaire (HTQ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0871538', 'cui_str': 'Ethnopsychiatry'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",318.0,0.116662,"The findings do not provide evidence that either BBAT or mixed physical activity as add-on treatment bring significantly larger improvement on symptoms of PTSD compared to TAU alone for adult, trauma-affected refugees.","[{'ForeName': 'Maja Sticker', 'Initials': 'MS', 'LastName': 'Nordbrandt', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sonne', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carlsson', 'Affiliation': 'Competence Centre for Transcultural Psychiatry, Mental Health Centre Ballerup, Mental Health Services of the Capital Region, Ballerup, Denmark.'}]",PloS one,['10.1371/journal.pone.0230300']
490,32202124,Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial.,"OBJECTIVE


Chronic mechanical neck pain is associated with musculoskeletal tissue alterations. Active trigger points in the trapezius and levator scapulae muscles are common in patients with chronic mechanical neck pain. In this study, we compared the effect of dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT on pain, pain pressure threshold, cervical range of motion and neck disability in patients with chronic mechanical neck pain.
METHODS


A randomised, single-blind clinical trial was carried out involving 101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54). Participants received two treatment sessions. The intervention group received MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP). The control group received MT plus SDN. Outcomes measures were: pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI).
RESULTS


This study found that between-group differences in pain intensity were statistically significant (P<0.01). Pain decreased after the first intervention in the DN+MT group (3.47±0.25 points on the NPRS) and even more so after the second intervention (4.76±0.24 points on the NPRS). After 4 weeks, pain intensity differed from baseline by 4.89±0.27 points on the NPRS. Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group. After the first intervention, a significant increase in PPT within the DN+MT group (3.09±0.8 kg/cm 2 ) was observed. Cervical ROM also showed highly statistically significant differences. After 4 weeks, a statistically significant reduction (P<0.001) in NDI was observed between the two groups.
CONCLUSION


Our results show that DN+MT is efficacious and significantly better than SDN+MT at reducing pain intensity, PPT, neck disability and cervical ROM in patients with chronic mechanical neck pain.
LEVEL OF EVIDENCE


1b.",2020,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"['patients with chronic mechanical neck pain', '101 participants with chronic mechanical neck pain, divided into an intervention group (DN+MT, n=47) and a control group (SDN+MT, n=54']","['SDN+MT', 'MT in conjunction with DN of the most mechano-sensitive myofascial trigger point (MTrP', 'dry needling', 'DN+MT', 'manual therapy', 'MT plus SDN', 'dry needling (DN) combined with manual therapy (MT) to sham dry needling (SDN) combined with MT']","['pain, pain pressure threshold, cervical range of motion and neck disability', 'pain intensity (numeric pain rating scale, NPRS), pressure pain threshold (PPT), cervical range of motion (ROM) and neck disability (neck disability index, NDI', 'Pain', 'pain intensity, PPT, neck disability and cervical ROM', 'Cervical ROM', 'pain intensity', 'NDI', 'PPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",101.0,0.15229,Statistically significant differences (P<0.001) in PPT were also found between the intervention group and the control group.,"[{'ForeName': 'Gracia M', 'Initials': 'GM', 'LastName': 'Gallego-Sendarrubias', 'Affiliation': 'Physiotherapy Department, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Martín', 'Affiliation': 'Simplifying Research Institute, Toledo, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2018-011682']
491,32169923,Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.,"OBJECTIVE


To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
DESIGN


Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
SETTING


11 diabetes clinics in England and Wales.
PARTICIPANTS


Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention.
INTERVENTION


We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.
RESULTS


Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.
CONCLUSIONS


Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.
TRIAL REGISTRATION NUMBER


ISRCTN17551624.",2020,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"['Of the five Diabetes PedsQL dimensions', 'children with type 1 diabetes', '11 diabetes clinics in England and Wales', 'Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention']","['standardised self-management kits', 'Standardised self-management kits']","['serious adverse reactions', 'total score', 'change in HbA1c', 'Diabetes Pediatric Quality of Life Inventory (PedsQL', 'blood glucose readings']","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",308.0,0.115808,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Noyes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK jane.noyes@bangor.ac.uk.'}, {'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Allen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'School of Journalism, Media and Culture, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Sylvestre', 'Affiliation': 'Manchester Academic Health Science (MAHSC) Clinical Trials Unit, Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Whitaker', 'Affiliation': 'Whitaker Research Limited, Rhos on Sea, North Wales, UK.'}, {'ForeName': 'Seow Tien', 'Initials': 'ST', 'LastName': 'Yeo', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032163']
492,32404599,Effect of blood insulin level on postprandial hypotension in elderly people.,"OBJECTIVES


The aim of the study is to discuss the effect of postprandial insulin level on blood pressure in elderly patients by comparing the blood pressure, blood glucose, and insulin levels between patients with postprandial hypotension (PPH) and non-PPH over 80 years old during fasting and within 2 h after meal, and observing the changes of parameters in patients with PPH before and after treatment with acarbose.
METHODS AND MATERIALS


Twenty-five PPH patients and 27 non-PPH patients were selected. The blood pressure, blood glucose, and insulin levels during fasting and within 2 h after meal were monitored. Patients with PPH were treated with acarbose. All parameters were checked one week later.
RESULTS


(1) Preprandial blood pressure in PPH group was significantly higher than that in non-PPH group (152.00 ± 15.62 mmHg vs. 136.40 ± 14.12 mmHg, P < 0.05). (2) The maximum decrease of postprandial systolic blood pressure (SBP) in PPH group was significantly increased compared with that of the control group (32.20 ± 13.19 mmHg vs. 9.67 ± 8.38 mmHg, P < 0.05). The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05). (3) After acarbose treatment, the decrease of postprandial SBP in PPH group was significantly reduced compared with that before treatment (22.67 ± 6.98 mmHg vs. 32.60 ± 9.55 mmHg, P < 0.05); the increase of postprandial blood glucose was also significantly reduced in PPH group (2.37 ± 1.63 mmol/L vs. 3.39 ± 1.62 mmol/L, P < 0.05); the increase of postprandial insulin level was reduced significantly in PPH group (12.09 ± 3.96 mU/L vs. 22.33 ± 1.78 mU/L, P < 0.05). (4) There was no correlation between the maximum decrease of postprandial SBP and the maximum increase of blood glucose (r = -0.008, P = 0.961), but the maximum decrease of postprandial SBP was positively correlated with the maximum increase of insulin (r = 0.381, P = 0.032).
CONCLUSION


PPH tends to occur in elderly people with elevated basal blood pressure before meal. PPH is associated with an abnormal increase of postprandial insulin secretion. Reducing the increase of postprandial insulin is one of the mechanisms of acarbose in the treatment of PPH.",2020,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"['elderly people with elevated basal blood pressure before meal', 'patients with postprandial hypotension (PPH) and non-PPH over 80\u2009years old during fasting and within 2\u2009h after meal, and observing the changes of parameters in patients with PPH before and after treatment with', 'Twenty-five PPH patients and 27 non-PPH patients were selected', 'Patients with PPH', 'elderly people', 'elderly patients']","['blood insulin level', 'PPH', 'postprandial insulin level', 'acarbose']","['postprandial insulin', 'postprandial hypotension', 'blood pressure', 'postprandial insulin level', 'blood glucose', 'Preprandial blood pressure', 'postprandial systolic blood pressure (SBP', 'postprandial blood glucose', 'postprandial blood glucose and insulin levels', 'postprandial SBP', 'blood pressure, blood glucose, and insulin levels', 'postprandial insulin secretion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",25.0,0.0150893,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Six Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Kejing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000450']
493,32160205,Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial.,"Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.",2020,No adverse events related to the trial procedures were reported.,"['stroke', 'Sixty participants', 'acute ischemic stroke patients']","['intensive mobile BP management strategy versus usual care', 'intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups', 'intensive management']","['Measuring blood pressure (BP', 'median of half-day blocks fulfilling the BP measurement criteria per patient', 'Remote BP measurement, data transmission, storage, and centralized monitoring system', '1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",57.0,0.095621,No adverse events related to the trial procedures were reported.,"[{'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jong-Moo', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Nowon Eulji Medical Center, Department of Neurology, Eulji University, Seoul, Republic of Korea.'}, {'ForeName': 'Tai Hwan', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Joungsim', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'JongShill', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Keon-Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'JiSung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Chae', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Joon', 'Initials': 'HJ', 'LastName': 'Bae', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0229483']
494,32152156,Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial.,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.
METHODS AND ANALYSIS


A single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.
ETHICS AND DISSEMINATION


Ethics approval was obtained from NHS Health Research Authority - London - Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17 th  March 2016.  WHO trial registration data set  available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.
TRIAL PROTOCOL VERSION


12, 19 th  July 2018.",2020,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","['Young people aged 16 to 24', '12, 19 th  July 2018', 'young people in the UK', '6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK']","['safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing', 'safetxt intervention', 'safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system', 'mobile phone messaging']","['partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners', 'cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests', 'chlamydia and gonorrhoea infection']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0041976', 'cui_str': 'Urethritis'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C0079990', 'cui_str': 'Notification, Partner'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]",6250.0,0.307453,"INTRODUCTION


Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK caroline.free@lshtm.ac.uk.'}, {'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Palmer', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Clinical Trials Unit, MSD, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'French', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Centre for Global Health, King's College London, London, London, UK.""}, {'ForeName': 'Ford Colin Ian', 'Initials': 'FCI', 'LastName': 'Hickson', 'Affiliation': 'Sigma Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Wellings', 'Affiliation': 'Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Julia V', 'Initials': 'JV', 'LastName': 'Bailey', 'Affiliation': 'Primary Care and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hart', 'Affiliation': 'Department of Infection and Population Health, University College London, London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Outcomes Research and Effectivenes, University College London, London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Clayton', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Ploubidis', 'Affiliation': 'Department of Social Science, University College London Institute of Education, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Katy M E', 'Initials': 'KME', 'LastName': 'Turner', 'Affiliation': 'Bristol Vetinary School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Devries', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031635']
495,32193820,Effect of diode laser application as an adjunct to nonsurgical periodontal therapy on the reduction of red complex microorganisms in type 2 diabetics with chronic periodontitis.,"Bactericidal and detoxification effects of diode laser (DL) have been reported in periodontal treatment. The objective of this study was investigating the additional effect of DL with nonsurgical periodontal treatment on the red complex bacteria in type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP). Sixty type 2 DM patients with chronic periodontitis (CP) were randomly assigned in two parallel groups to receive scaling root planning (SRP, n = 30) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n = 30). Recording of clinical parameters and subgingival plaque sampling were performed at baseline, and post therapy (1 and 3 months after treatment). Amounts of Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia were evaluated with quantitative RT-PCR. Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points. No additional benefit of DL as an adjunct to nonsurgical periodontal therapy was recognized in the reduction of P. gingivalis, T. denticola, and T. forsythia for type 2 DM patients with CP. Further studies are required to clarify the effects of diode laser on the other periodontopathogens.",2020,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","['Sixty type 2 DM patients with chronic periodontitis (CP', 'type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP', 'type 2 diabetics with chronic periodontitis']","['diode laser application', 'diode laser (DL', 'DL', 'scaling root planning (SRP, n\u2009=\u200930) or SRP followed by DL periodontal pocket irradiation (SRP + DL, n\u2009=\u200930', 'diode laser']","['bacterial reductions', 'Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia', 'red complex microorganisms']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0031094', 'cui_str': 'Periodontal Pocket'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Bacteroides forsythus'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}]",60.0,0.0363979,"Significant reductions for numbers of all three bacterial species were observed at 1 and 3 months compared with baseline for both treatments (p < 0.001), but no significant differences were found between two groups regarding bacterial reductions at these follow-up time points.","[{'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Kocak', 'Affiliation': 'Izzet Baysal Mouth and Dental Health Center, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sağlam', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. dtmehmetsaglam@gmail.com.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Department of Microbiology, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Seyit Ali', 'Initials': 'SA', 'LastName': 'Kayis', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Karabük University, Karabuk, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kebapcilar', 'Affiliation': 'Department of Endocrinology and Metabolism Disease, School of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sema S', 'Initials': 'SS', 'LastName': 'Hakki', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Selcuk University, Konya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-02997-1']
496,32205449,"Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial.","BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.
PRIMARY OBJECTIVE


The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.
STUDY HYPOTHESIS


We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.
TRIAL DESIGN


This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.
MAJOR ELIGIBILITY CRITERIA


Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.
PRIMARY ENDPOINT


The primary endpoint is overall survival.
SAMPLE SIZE


To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.
TRIAL REGISTRATION


ClinicalTrials.gov:NCT03772028.",2020,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","['patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5\u2009mm in maximum dimension', 'Patients with resectable umbilical, spleen, or local bowel lesions', 'FIGO stage III epithelial ovarian cancer', '538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer', 'Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery', 'patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery', '538 patients need to be randomized', 'patients who are candidates for primary cytoreductive surgery', 'patients with primary FIGO stage III epithelial ovarian cancer']","['Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC', 'platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'HIPEC', 'HIPEC or no HIPEC']","['recurrence-free and overall survival', 'overall survival', 'overall survival events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",538.0,0.335434,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Koole', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'van Stein', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Barton', 'Affiliation': 'Department of Gynaecological Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': 'Queensland Centre for Gynaecological Cancer, Herston, Queensland, Australia.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Gynaecology Oncology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Department of Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Gynaecology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Colombo', 'Affiliation': 'Department of Surgical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'W J van', 'Initials': 'WJV', 'LastName': 'Driel', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands w.v.driel@nki.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001231']
497,32165549,MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.,"OBJECTIVES


To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain.
DESIGN


Three arm randomised feasibility trial.
SETTING


Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing.
PARTICIPANTS


Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised.
INTERVENTIONS


Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days.
PRIMARY AND SECONDARY OUTCOME MEASURES


Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months.
RESULTS


The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1).
CONCLUSIONS


Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement.
TRIAL REGISTRATION NUMBERS


NCT02721108; ISRCTN10925965; Results.",2020,"Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control).","['women with chronic pelvic pain', 'Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up', '90 women were randomised', 'women with chronic pelvic pain presenting to gynaecology clinics', 'Women were recruited at two gynaecology clinics in the UK', 'Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6\u2009months or more, and had access to a computer or smartphone']","['smartphone app using psychological approaches', 'Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app', 'modified, pre-existing, mindfulness meditation smartphone app']","['pain acceptance scores', 'length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",90.0,0.260056,"Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control).","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Forbes', 'Affiliation': ""IoPPN, King's College London, London, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Newton', 'Affiliation': 'Centre for Primary Care and Population Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cantalapiedra Calvete', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': 'Pelvic Pain Support Network, Poole, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Women's Health Research Unit, Barts and The London School of Medicine and Dentistry, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Centre for Primary Care and Population Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Department of Public Health, University of Granada, Granada, Spain.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Röhricht', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Centre for Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ball', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK elizabeth.ball9@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-030164']
498,31653133,"The Effect of Relaxation Techniques on Anxiety, Fatigue and Sleep Quality of Parents of Children with Leukemia under Chemotherapy in South East Iran.","INTRODUCTION


Cancer can cause emotional stress in parents, which has a negative impact on the quality of their life. Also, anxiety and psychological stress have a negative effect on the health of parents, and fatigue causes a sense of weakness and reduces the capacity for mental and physical activity, and insomnia, as well as stress and inability to perform their occupational and social functions. This study aimed to determine the effect of relaxation techniques on anxiety, fatigue, and sleep quality of parents of children with leukemia under chemotherapy in South East Iran in 2015.
METHODS


This is a randomized controlled trial study. The study population included parents of children with leukemia undergoing chemotherapy who were admitted to a teaching hospital in South East Iran. One hundred twenty parents were randomly assigned to control and intervention groups, and the experimental group was provided with Benson relaxation technique. Data collection tool included a demographic questionnaire, state-trait anxiety inventory, Brief Fatigue Inventory, and sleep quality inventory. Data analysis was done by SPSS 16 and paired t-test, Wilcoxon, Mann- Whitney, regression, One - Way ANOVA and Pearson tests were performed, and p ≤ 0.05 was statistically significant.
RESULTS


The mean score of state anxiety in the intervention group was 60.86 ± 8.95 and 35.95 ± 4.61 before and after the intervention, respectively. The mean score of trait anxiety was 56.56 ± 4.75 and 34.45 ± 4.95. The mean score of the fatigue was 73.83 ± 14.63 and 43.71 ± 11. 06, and the mean score of the quality of sleep was 13.5 ± 6.05 and 5.7 ± 3.43 before and after the intervention respectively. There was a statistically significant difference among state-trait anxiety, fatigue, and sleep quality in intervention and control groups after the intervention. There was a statistically significant negative correlation between fatigue and age, but there was no statistically significant relationship among the mean fatigue, weight, the number of sons and daughters, education, occupation, gender, place of residence and income (p> 0.05). There was no statistically significant relationship among the quality of sleep of parents, education, gender, and place of residence, but there was a statistically significant relationship between state anxiety and education (p≤0.05).
CONCLUSION


The results can predispose family-centered nursing care to support more the parents of children with cancer in the face of the stress of illness. Developing programs for training muscle relaxation techniques will improve family functioning and mental health.",2019,"There was a statistically significant difference among state-trait anxiety, fatigue, and sleep quality in intervention and control groups after the intervention.","['parents of children with leukemia under chemotherapy in South East Iran in 2015', 'parents of children with leukemia undergoing chemotherapy who were admitted to a teaching hospital in South East Iran', 'Parents of Children with Leukemia under Chemotherapy in South East Iran', 'One hundred twenty parents']","['experimental group was provided with Benson relaxation technique', 'relaxation techniques', 'Relaxation Techniques']","['anxiety, fatigue, and sleep quality', 'demographic questionnaire, state-trait anxiety inventory, Brief Fatigue Inventory, and sleep quality inventory', 'Anxiety, Fatigue and Sleep Quality', 'mean score of the quality of sleep', 'state-trait anxiety, fatigue, and sleep quality', 'mean score of state anxiety', 'mean fatigue, weight, the number of sons and daughters, education, occupation, gender, place of residence and income', 'quality of sleep of parents, education, gender, and place of residence', 'mean score of trait anxiety']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035029', 'cui_str': 'Relaxation Technics'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",120.0,0.029784,"There was a statistically significant difference among state-trait anxiety, fatigue, and sleep quality in intervention and control groups after the intervention.","[{'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Pouraboli', 'Affiliation': 'School of Nursing and Midwifery, Department of Pediatric and Neonatal Nursing, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Poodineh', 'Affiliation': 'Department of Community Health, Nursing and Midwifery School of Razi, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Jahani', 'Affiliation': 'Department of Biostatistic, Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2019.20.10.2903']
499,32109422,"Metformin to reduce metabolic complications and inflammation in patients on systemic glucocorticoid therapy: a randomised, double-blind, placebo-controlled, proof-of-concept, phase 2 trial.","BACKGROUND


An urgent need to reduce the metabolic side-effects of glucocorticoid overexposure has been recognised, as glucocorticoid excess can lead to Cushing's syndrome, which is associated with high morbidity. We aimed to evaluate the potential of metformin to reverse such effects while sparing the anti-inflammatory benefits of glucocorticoids.
METHODS


We did a randomised, double-blind, placebo-controlled, proof-of-concept, phase 2 trial involving four hospitals in the UK. Patients without diabetes were eligible if they were between the ages of 18 and 75 years with an inflammatory disease treated with continuous prednisolone (≥20 mg/day for ≥4 weeks and remaining on ≥10 mg/day for the subsequent 12 weeks, or its cumulative dose-equivalent). Eligible patients were randomly allocated (1:1) to either the metformin or placebo groups, using a computer-generated randomisation table stratified according to age and BMI. Metformin and placebo were administered orally for 12 weeks in escalating doses: 850 mg/day for the first 5 days, 850 mg twice a day for the next 5 days, and 850 mg three times a day subsequently. The primary outcome was the between-group difference in visceral-to-subcutaneous fat area ratio over 12 weeks, assessed by CT. Secondary outcomes included changes in metabolic, bone, cardiovascular, and inflammatory parameters over 12 weeks. Our analysis followed a modified intention-to-treat principle for the primary outcome. This study is registered with ClinicalTrials.gov, NCT01319994.
FINDINGS


Between July 17, 2012, and Jan 14, 2014, 849 patients were assessed for study eligibility, of which 53 were randomly assigned to receive either metformin (n=26) or placebo (n=27) for 12 weeks. 19 patients in the metformin group and 21 in the placebo group were eligible for the primary outcome analysis. Both groups received an equivalent cumulative dose of glucocorticoids (1860 mg prednisolone-equivalent [IQR 1060-2810] in the metformin group vs 1770 mg [1020-2356] in the placebo group); p=0·76). No change in the visceral-to-subcutaneous fat area ratio between the treatment groups was observed (0·11, 95% CI -0·02 to 0·24; p=0·09), but patients in the metformin group lost truncal subcutaneous fat compared with the placebo group (-3835 mm 2 , 95% CI -6781 to -888; p=0·01). Improvements in markers of carbohydrate, lipid, liver, and bone metabolism were observed in the metformin group compared with the placebo group. Additionally, those in the metformin group had improved fibrinolysis, carotid intima-media thickness, inflammatory parameters, and clinical markers of disease activity. The frequency of pneumonia (one event in the metformin group vs seven in the placebo group; p=0·01), overall rate of moderate-to-severe infections (two vs 11; p=0·001), and all-cause hospital admissions due to adverse events (one vs nine; p=0·001) were lower in the metformin group than in the placebo group. Patients in the metformin group had more events of diarrhoea than the placebo group (18 events vs eight; p=0·01).
INTERPRETATION


No significant changes in the visceral-to-subcutaneous fat area ratio between the treatment groups were observed; however, metformin administration did improve some of the metabolic profile and clinical outcomes for glucocorticoid-treated patients with inflammatory disease, which warrants further investigation.
FUNDING


Barts Charity and Merck Serono.",2020,"Improvements in markers of carbohydrate, lipid, liver, and bone metabolism were observed in the metformin group compared with the placebo group.","['four hospitals in the UK', 'Patients without diabetes were eligible if they were between the ages of 18 and 75 years with an inflammatory disease treated with', 'patients on systemic glucocorticoid therapy', 'Eligible patients', 'Between July 17, 2012, and Jan 14, 2014, 849 patients were assessed for study eligibility, of which 53', '19 patients in the']","['metformin', 'placebo', 'Metformin', 'glucocorticoids', 'Metformin and placebo', 'prednisolone-equivalent [IQR 1060-2810] in the metformin', 'metformin or placebo', 'continuous prednisolone']","['metabolic profile and clinical outcomes', 'overall rate of moderate-to-severe infections', 'events of diarrhoea', 'fibrinolysis, carotid intima-media thickness, inflammatory parameters, and clinical markers of disease activity', 'visceral-to-subcutaneous fat area ratio', 'metabolic complications and inflammation', 'markers of carbohydrate, lipid, liver, and bone metabolism', 'changes in metabolic, bone, cardiovascular, and inflammatory parameters', 'frequency of pneumonia', 'truncal subcutaneous fat']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3540777', 'cui_str': 'Glucocorticoids, Systemic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",849.0,0.523472,"Improvements in markers of carbohydrate, lipid, liver, and bone metabolism were observed in the metformin group compared with the placebo group.","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Pernicova', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Endocrinology and Metabolic Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Centre for Experimental Medicine & Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Ajodha', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Sahdev', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Bestwick', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Plamena', 'Initials': 'P', 'LastName': 'Gabrovska', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Olufunso', 'Initials': 'O', 'LastName': 'Akanle', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ramzi', 'Initials': 'R', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Blerina', 'Initials': 'B', 'LastName': 'Kola', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Stadler', 'Affiliation': ""Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Faculty of Life Sciences and Medicine, Department of Diabetes, King's College London, London, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fraser', 'Affiliation': 'Department of Medicine, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Division of Endocrinology, Diabetes & Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Grossman', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Pitzalis', 'Affiliation': 'Centre for Experimental Medicine & Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Márta', 'Initials': 'M', 'LastName': 'Korbonits', 'Affiliation': 'Centre for Endocrinology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: m.korbonits@qmul.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30021-8']
500,32058976,"International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.","BACKGROUND


Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain.
OBJECTIVE


This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement.
METHODS


On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement.
RESULTS


The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise.
CONCLUSIONS


Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).",2020,A total of 98.27% (5157/5248) of the app-based baseline questions were answered.,"['18- to 34-year-old women with primary dysmenorrhea in a self-care setting', 'Women with Menstrual Pain', 'women of reproductive age']",['specific smartphone app'],"['Behavior change techniques (BCTs', 'menstrual pain']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",,0.176992,A total of 98.27% (5157/5248) of the app-based baseline questions were answered.,"[{'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Alizé A', 'Initials': 'AA', 'LastName': 'Rogge', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Armour', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': ""D'Adamo"", 'Affiliation': 'Center for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': 'Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hung-Rong', 'Initials': 'HR', 'LastName': 'Yen', 'Affiliation': 'School of Chinese Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Mei-Yao', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ari Ojeda Ocampo', 'Initials': 'AOO', 'LastName': 'Moré', 'Affiliation': 'Integrative Medicine and Acupuncture Division, University Hospital, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Witt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pach', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}]",JMIR mHealth and uHealth,['10.2196/14661']
501,32157099,Acute increases in brain-derived neurotrophic factor in plasma following physical exercise relates to subsequent learning in older adults.,"Multidomain lifestyle interventions represents a promising strategy to counteract cognitive decline in older age. Brain-derived neurotrophic factor (BDNF) is essential for experience-dependent plasticity and increases following physical exercise, suggesting that physical exercise may facilitate subsequent learning. In a randomized-controlled trial, healthy older adults (65-75 years) completed a 12-week behavioral intervention that involved either physical exercise immediately before cognitive training (n = 25; 13 females), physical exercise immediately after cognitive training (n = 24; 11 females), physical exercise only (n = 27; 15 females), or cognitive training only (n = 21; 12 females). We hypothesized that cognition would benefit more from cognitive training when preceded as opposed to followed by physical exercise and that the relationship between exercise-induced increases in peripheral BDNF and cognitive training outcome would be greater when cognitive training is preceded by physical exercise. Greater increases of plasma BDNF were associated with greater cognitive training gains on trained task paradigms, but only when such increases preceded cognitive training (ß = 0.14, 95% CI [0.04, 0.25]). Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]). The study provides the first empirical support for a time-critical but advantageous role for post-exercise increases in peripheral BDNF for learning at an interindividual level in older adults, with implications for future multidomain lifestyle interventions.",2020,"Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]).","['older adults', 'healthy older adults (65-75 years', 'older age']","['behavioral intervention that involved either physical exercise immediately before cognitive training', 'physical exercise immediately after cognitive training', 'Multidomain lifestyle interventions', 'Brain-derived neurotrophic factor (BDNF', 'physical exercise only (n\u2009=\u200927; 15 females), or cognitive training']","['plasma BDNF', 'Average cognitive training outcome', 'cognitive training gains', 'cognitive training', 'peripheral BDNF and cognitive training outcome']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.022719,"Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]).","[{'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden. jonna.nilsson@ki.se.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden.'}]",Scientific reports,['10.1038/s41598-020-60124-0']
502,32102708,"Associations between enteric pathogen carriage and height-for-age, weight-for-age and weight-for-height in children under 5 years old in urban Dhaka, Bangladesh.","Nutritional factors and infectious agents may contribute to paediatric growth deficits in low- and middle-income countries; however, the contribution of enteric pathogens is only beginning to be understood. We analysed the stool from children <5 years old from an open cohort, cluster-randomised controlled trial of a point-of-collection water chlorinator in urban Bangladesh. We compared the presence/absence of 15 enteric pathogens detected via multiplex, molecular methods in the stool with concurrent Z-scores/Z-score cut-offs (-2 standard deviations (s.d.)) for height-for-age (HAZ/stunting), weight-for-age (WAZ/underweight) and weight-for-height (WHZ/wasting), adjusted for sociodemographic and trial-related factors, and measured caregiver-reported diarrhoea. Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp. (40%), Salmonella enterica (33%), enterotoxigenic E. coli (28%) and Shigella spp. (27%)) while reported 7-day diarrhoea prevalence was 6%, suggesting high subclinical infection rates. Many children were stunted (26%) or underweight (24%). Adjusted models suggested Giardia spp. detection was associated with lower HAZ (-0.22 s.d., 95% CI -0.44 to 0.00; prevalence ratio for stunting: 1.39, 95% CI 0.94-2.06) and potentially lower WAZ. No pathogens were associated with reported diarrhoea in adjusted models. Giardia spp. carriage may be associated with growth faltering, but not diarrhoea, in this and similar low-income settings. Stool-based enteric pathogen detection provides a direct indication of previous exposure that may be useful as a broader endpoint of trials of environmental interventions.",2020,"Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp.","['children under 5 years old in urban Dhaka, Bangladesh', 'children <5 years old from an open cohort, cluster-randomised controlled trial of a point-of-collection water chlorinator in urban Bangladesh']",[],"['Salmonella enterica', 'Enteric pathogen prevalence', 'diarrhoea', '7-day diarrhoea prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",[],"[{'cui': 'C0445750', 'cui_str': 'Salmonella enterica'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.160984,"Enteric pathogen prevalence in the stool was high (88% had ≥1 enteric pathogen, most commonly Giardia spp.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berendes', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Capone', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Knee', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holcomb', 'Affiliation': 'Department of Environmental Sciences and Engineering, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sultana', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'School of Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'School of Civil and Environmental Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}]",Epidemiology and infection,['10.1017/S0950268820000369']
503,31784988,Use of the Dyskinesia Impairment Scale in non-ambulatory dyskinetic cerebral palsy.,"AIM


To assess the responsiveness, concurrent validity, and feasibility of the Dyskinesia Impairment Scale (DIS) in non-ambulatory patients with dyskinetic cerebral palsy (CP).
METHOD


The study is a secondary analysis of data collected in the IDYS trial, a randomized controlled trial on the effects of intrathecal baclofen (ITB). The DIS and Barry-Albright Dystonia Scale (BADS) were conducted at baseline and after 3 months of ITB or placebo treatment. Responsiveness was assessed by comparing the effect sizes and correlation of change after treatment between the DIS and BADS. Concurrent validity was evaluated by assessing the correlations between scales. Feasibility was evaluated for each DIS item by the number of participants who successfully accomplished the item.
RESULTS


Thirty-three non-ambulatory patients (9 females, 24 males) with dyskinetic CP (ITB-treated: n=17, mean [SD] age: 14y 1mo [4y 1mo]; placebo-treated: n=16, mean [SD] age: 14y 7mo [4y]) were included in the study. The effect sizes for BADS and DIS were similar in The ITB-treated group (-0.29 and -0.22 respectively). Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001). The DIS dystonia subscale and BADS correlated at baseline and follow-up (r=0.78; p<0.001 and r=0.79; p<0.001). Not all DIS activity items could be performed in this sample of patients.
INTERPRETATION


For non-ambulatory patients with dyskinetic CP, the responsiveness of the DIS equalled the responsiveness of BADS. Concurrent validity was adequate. Feasibility for activity items was restricted in patients with severe dyskinetic CP.
WHAT THIS PAPER ADDS


The Dyskinesia Impairment Scale (DIS) and Barry-Albright Dystonia Scale showed similar responsiveness in non-ambulatory patients with dyskinetic cerebral palsy (CP). No floor or ceiling effect was observed for DIS in non-ambulatory participants. The concurrent validity of DIS was adequate in non-ambulatory participants. Patients with dyskinetic CP in Gross Motor Function Classification System levels IV and V could not perform all DIS activity items.",2020,Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001).,"['non-ambulatory dyskinetic cerebral palsy', 'ambulatory patients with dyskinetic CP', 'patients with severe dyskinetic CP', 'Thirty-three non-ambulatory patients (9 females, 24 males) with dyskinetic CP (ITB-treated: n=17, mean [SD] age: 14y 1mo [4y 1mo]; placebo-treated: n=16, mean [SD] age: 14y 7mo [4y]) were included in the study', 'non-ambulatory patients with dyskinetic cerebral palsy (CP']","['intrathecal baclofen (ITB', 'placebo', 'Dyskinesia Impairment Scale (DIS']","['DIS and Barry-Albright Dystonia Scale (BADS', 'DIS dystonia subscale', 'Dyskinesia Impairment Scale', 'BADS and DIS', 'DIS dystonia subscale and BADS']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0270742', 'cui_str': 'Cerebral Palsy, Dyskinetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439842', 'cui_str': 'Dyskinetic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}]","[{'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",33.0,0.0242173,Changes after treatment on the DIS dystonia subscale correlated with changes on the BADS (r=0.64; p<0.001).,"[{'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Haberfehlner', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Bonouvrié', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Boeschoten', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Fleuren', 'Affiliation': 'Department of Neurology, Section of Pediatric Neurology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Elegast', 'Initials': 'E', 'LastName': 'Monbaliu', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven Campus Brugge, Brugge, Belgium.'}, {'ForeName': 'Jules G', 'Initials': 'JG', 'LastName': 'Becher', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'R Jeroen', 'Initials': 'RJ', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Neurology, Section of Pediatric Neurology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Annemieke I', 'Initials': 'AI', 'LastName': 'Buizer', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14415']
504,32193258,Independent medical evaluation of general practitioners' follow-up of sick-listed patients: a cross-sectional study in Norway.,"OBJECTIVES


The study was designed to examine the sufficiency of general practitioners' (GPs) follow-up of patients on sick leave, assessed by independent medical evaluators.
DESIGN


Cross-sectional study SETTING: Primary health care in the Western part of Norway. The study reuses data from a randomised controlled trial-the Norwegian independent medical evaluation trial (NIME trial).
PARTICIPANTS


The intervention group in the NIME trial: Sick-listed workers having undergone an independent medical evaluation by an experienced GP at 6 months of unremitting sick leave (n=937; 57% women). In the current study, the participants were distributed into six exposure groups defined by gender and main sick leave diagnoses (women/musculoskeletal, men/musculoskeletal, women/mental, men/mental, women/all other diagnoses and men/all other diagnoses).
OUTCOME MEASURE


The independent medical evaluators assessment (yes/no) of the sufficiency of the regular GPs follow-up of their sick-listed patients.
RESULTS


Estimates from generalised linear models demonstrate a robust association between men with mental sick leave diagnoses and insufficient follow-up by their regular GP first 6 months of sick leave (adjusted relative risk (RR)=1.8, 95% CI=1.15-1.68). Compared with the reference group, women with musculoskeletal sick leave diagnoses, this was the only significant finding. Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
CONCLUSIONS


Assessment by an independent medical evaluator showed that men with mental sick leave diagnoses may be at risk of insufficient follow-up by their GP. Efforts should be made to clarify unmet needs to initiate relevant actions in healthcare and work life. Avoiding marginalisation in work life is of the utmost importance.
TRIAL REGISTRATION NUMBER


NCT02524392; Post-results.",2020,"Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
","['Primary health care in the Western part of Norway', 'participants were distributed into six exposure groups defined by gender and main sick leave diagnoses (women/musculoskeletal, men/musculoskeletal, women/mental, men/mental, women/all other diagnoses and men/all other diagnoses', 'Sick-listed workers having undergone an independent medical evaluation by an experienced GP at 6\u2009months of unremitting sick leave (n=937; 57% women']",[],['musculoskeletal diagnoses'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277662', 'cui_str': 'Independent Medical Examinations'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],[],,0.248772,"Men with musculoskeletal diagnoses (adjusted RR=1.4, 95% CI=0.92-2.09); men with other diagnoses (adjusted RR=1.0, 95% CI=0.58-1.73); women with mental diagnoses (adjusted RR=1.2, 95% CI=0.75-1.77) and women with other diagnoses (adjusted RR=1.3, 95% CI=0.58-1.73).
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Øyeflaten', 'Affiliation': 'Norwegian National Advisory Unit on Occupational Rehabilitation, Rauland, Norway irene.oyeflaten@arbeidoghelse.no.'}, {'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Maeland', 'Affiliation': 'NORCE Norwegian Research Centre AS, Bergen, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Haukenes', 'Affiliation': 'NORCE Norwegian Research Centre AS, Bergen, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-032776']
505,32189108,'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.,"BACKGROUND


The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension.
METHODS


Attainment of 'minimal symptom expression' was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. 'Minimal symptom expression' was defined as MG-ADL total score of 0-1 or MG-QOL15 total score of 0-3.
RESULTS


At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved 'minimal symptom expression' increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved 'minimal symptom expression' (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports.
CONCLUSIONS


Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained 'minimal symptom expression' based on patient-reported outcomes. 'Minimal symptom expression' may be a useful tool in measuring therapy effectiveness in gMG.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01997229, NCT02301624.",2020,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","['patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with', 'Patients with AChR+ refractory gMG']","['placebo/eculizumab', 'acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG', 'placebo', 'eculizumab/eculizumab and placebo/eculizumab', 'placebo [MG-ADL', 'open-label eculizumab (MG-ADL', 'eculizumab']","['minimal symptom expression', 'Minimal symptom expression', 'gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0765796', 'cui_str': 'GMG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0905574,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Department of Neurology, Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. john.vissing@regionh.dk.'}, {'ForeName': 'Saiju', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Alnylam Pharmaceuticals, 675 West Kendall Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA, 02210, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'Department of Neurology, University of North Carolina, 170 Manning Drive, Chapel Hill, NC, 27599-7025, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09770-y']
506,32188988,"Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


LATITUDE was a randomized, double-blind, international and phase 3 study of abiraterone acetate plus prednisone in patients with high-risk metastatic hormone-naïve prostate cancer. In the first interim analysis of LATITUDE (clinical cutoff date: 31 October 2016), significant prolongation in overall survival and radiographic progression-free survival (co-primary endpoints) was observed when compared with placebo. The results of the Japanese subgroup analysis of LATITUDE first interim analysis were consistent with those of the overall population. In this study, overall survival and safety results from the final analysis of the Japanese subgroup of the LATITUDE study are presented (clinical cutoff date: 15 August 2018).
METHODS


Abiraterone acetate (1000 mg/day) and prednisone (5 mg/day) were administered orally in the abiraterone acetate plus prednisone group, and matching placebos in the placebo group.
RESULTS


Of the 1199 patients included in LATITUDE, 70 constituted the Japanese subgroup (abiraterone acetate plus prednisone: n = 35, placebo: n = 35). Following a median (range) follow-up of 56.6 (2.5, 64.2) months, the median overall survival was not reached in both the treatment arms of the Japanese subgroup (hazard ratio: 0.61; 95% confidence interval: 0.27-1.42; nominal P = 0.2502). A total of 23 deaths (abiraterone acetate plus prednisone: 9 [25.7%], placebo group: 14 [40.0%]) were reported in Japanese subgroup. Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
CONCLUSIONS


In this Japanese subgroup analysis, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable efficacy and safety outcomes in patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer. Survival benefits observed in the Japanese subgroup first interim analysis were sustained long-term and were consistent with the overall population.",2020,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","['Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer', 'patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer', 'group: 14 [40.0%]) were reported in Japanese subgroup', 'patients with high-risk metastatic hormone-naïve prostate cancer', '1199 patients included in LATITUDE']","['placebo', 'Abiraterone acetate', 'abiraterone acetate plus prednisone', 'prednisone', 'Japanese subgroup (abiraterone acetate plus prednisone']","['Survival benefits', 'Efficacy and safety', 'overall survival and radiographic progression-free survival', 'overall survival and safety', 'median overall survival', 'Grade 3/4 adverse events', 'efficacy and safety outcomes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.702251,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Sumiko', 'Initials': 'S', 'LastName': 'Kitani', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Ohtake', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Shibayama', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Namphuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa030']
507,32171064,"Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Whether blood eosinophil counts and exhaled nitric oxide (FeNO) are associated with important outcomes in mild asthma is unclear. In this prespecified subgroup analysis of a previously published open-label clinical trial, we aimed to assess associations between blood eosinophil counts and FeNO with outcomes and response to asthma treatment.
METHODS


In the previously reported 52-week, open-label, randomised controlled trial, people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia. Eligible participants were randomly assigned (1:1:1, stratified by country), to receive inhalers to take as-needed salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler). The primary outcome was the annual rates of asthma exacerbations per patient, and in this prespecified subgroup analysis, we assessed whether annual exacerbation rates in each treatment group were significantly different depending on levels of blood eosinophil count, FeNO, or a composite score of both. Analyses were done for patients with available biomarker measurements The study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000999538.
FINDINGS


675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO. Of the patients who received as-needed salbutamol, the proportion of patients having a severe exacerbation increased progressively with increasing blood eosinophil count (two [4%] of 49 participants with <0·15 × 10 9 /L, six [6%] of 93 with 0·15 to <0·3 × 10 9 /L, and 15 [19%] of 77 with ≥0·3 × 10 9 /L; p=0·014). There were no significant interactions between blood eosinophil count or FeNO level and the effect of as-needed budesonide-formoterol compared with as-needed salbutamol for either exacerbations or severe exacerbations. However, there were significant interactions between blood eosinophil count subgroups and the effect of maintenance budesonide plus as-needed salbutamol compared with as-needed salbutamol, both for exacerbations (p=0·0006) and severe exacerbations (p=0·0007). Maintenance budesonide plus as-needed salbutamol was more effective than as-needed salbutamol in patients with blood eosinophil counts of 0·3 × 10 9 /L or more, both for exacerbations (rate ratio 0·13 [95% CI 0·05-0·33]) and severe exacerbations (risk odds ratio 0·11 [0·03-0·45]). This difference was not seen for blood eosinophil counts of less than 0·15 × 10 9 /L (1·15 [0·51-1·28] for exacerbations and 5·72 [0·97-33·60] for severe exacerbations). There was no consistent interaction between treatment response and FeNO or the composite score.
INTERPRETATION


In patients with mild asthma, the effects of as-needed budesonide-formoterol on exacerbations are independent of biomarker profile, whereas the benefits of maintenance inhaled budesonide are greater in patients with high blood eosinophil counts than in patients with low counts.
FUNDING


AstraZeneca, Health Research Council of New Zealand.",2020,This difference was not seen for blood eosinophil counts of less than 0·15 ,"['10', 'patients with blood eosinophil counts of 0·3', '675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO', 'people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia', '0·13', 'patients with available biomarker measurements', '10 9', '49 participants with <0·15', 'patients with mild asthma', 'adults with mild asthma', 'Eligible participants']","['budesonide-formoterol', 'blood eosinophils and exhaled nitric oxide', 'salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler']","['blood eosinophil count', 'annual exacerbation rates', 'blood eosinophil counts', 'severe exacerbations', 'annual rates of asthma exacerbations', 'exacerbations (rate ratio', 'blood eosinophil count or FeNO level', 'levels of blood eosinophil count, FeNO, or a composite score of both']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",675.0,0.625881,This difference was not seen for blood eosinophil counts of less than 0·15 ,"[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory National Institute for Health Research Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeier', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand; Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Houghton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Oldfield', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30053-9']
508,32178568,Influence of Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia on Intraoperative Neuromonitoring during Thyroidectomy.,"OBJECTIVE


To examine the influence of sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA) on intraoperative neuromonitoring (IONM) during thyroidectomy.
STUDY DESIGN


A randomized controlled trial.
SETTING


The present study was conducted in a tertiary hospital.
SUBJECTS AND METHODS


Forty patients were randomly assigned to a sevoflurane-based combined intravenous and inhalation group (group S) or a propofol-based total intravenous group (group P). Anesthesia was induced with midazolam, sufentanil, propofol, and cisatracurium in both groups and was maintained with sevoflurane and remifentanil in group S and with TIVA with propofol and remifentanil in group P. IONM was performed intermittently according to the IONM formula standard.
RESULTS


The time until detection of the first positive electromyographic (EMG) signal was significantly longer in group S (median, 41.0 minutes [interquartile range, 37.5-49.3]) than in group P (37.0 minutes [33.3-41.5],  P  = .028). All patients in group P had a positive EMG signal at initial monitoring, whereas 8 patients (40.0%) in group S did not. The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P  = .006). The amplitude of the evoked potentials at V1, R1, R2, and V2 were similar between the groups.
CONCLUSION


Combined intravenous and inhaled anesthesia based on sevoflurane-remifentanil prolonged the time until detection of a positive EMG signal during IONM as compared with TIVA with propofol-remifentanil in patients undergoing thyroidectomy.",2020,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P  = .006).,"['The present study was conducted in a tertiary hospital', 'patients undergoing thyroidectomy', 'Forty patients']","['Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia', 'propofol-remifentanil', 'TIVA with propofol and remifentanil', 'sevoflurane-remifentanil', 'sevoflurane and remifentanil', 'sevoflurane-based combined intravenous and inhalation group', 'propofol-based total intravenous group', 'sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA', 'midazolam, sufentanil, propofol, and cisatracurium']","['time until detection of the first positive electromyographic (EMG) signal', 'intraoperative neuromonitoring (IONM', 'rate of positive EMG signal at initial monitoring', 'time until detection of a positive EMG signal', 'positive EMG signal']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",40.0,0.03895,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P  = .006).,"[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Head and Neck Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jiaonan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820912030']
509,31780142,Assessing the value of coronary artery computed tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected coronary artery disease. Initial cost analysis in the CAT-CAD randomized trial.,"BACKGROUND


Clinical and safety outcomes of the strategy employing coronary computed tomography angiography (CCTA) as the first-choice imaging test have recently been demonstrated in the recently published CAT-CAD randomized, prospective, single-center study. Based on prospectively collected data in this patient population, we aimed to perform an initial cost analysis of this approach.
METHODS


120 participants of the CAT-CAD trial (age:60.6 ± 7.9 years, 35% female) were included in the analysis. We analyzed medical resource use during the diagnostic and therapeutic episode of care. We prospectively estimated the cumulative cost for each strategy by multiplying the number of resources by standardized costs in accordance to medical databases and the 2015 Procedural Reimbursement Payment Guide.
RESULTS


The total cost of coronary artery disease (CAD) diagnosis was significantly lower in the CCTA group as compared to the direct invasive coronary angiography (ICA) group ($50,176 vs $137,032) with corresponding per-patient cost of $836 vs $2,284, respectively. Similarly, the entire diagnostic and therapeutic episode of care was significantly less expensive in the CCTA group ($227,622 vs $502,827) with corresponding per-patient cost of $4630 vs $8,380, respectively. Overall, the application of CCTA as a first-line diagnostic test in stable patients with indications to ICA resulted in a 63% reduction of CAD diagnosis costs and a 55% reduction composite of diagnosis and treatment costs during 90-days follow-up.
CONCLUSIONS


Application of CCTA as the first-line anatomic test in patients with suspected significant CAD decreased the total costs of diagnosis. This is likely attributable to reduced numbers of invasive tests and hospitalisations. Initial cost analysis of the CAT-CAD randomized trial suggests that this approach may provide significant cost savings for the entire health system.",2020,"The total cost of coronary artery disease (CAD) diagnosis was significantly lower in the CCTA group as compared to the direct invasive coronary angiography (ICA) group ($50,176 vs $137,032) with corresponding per-patient cost of $836 vs $2,284, respectively.","['120 participants of the CAT-CAD trial (age:60.6\u202f±\u202f7.9 years, 35% female', 'stable patients with indications for invasive angiography due to suspected coronary artery disease']","['strategy employing coronary computed tomography angiography (CCTA', 'CCTA', 'direct invasive coronary angiography (ICA']","['total cost of coronary artery disease (CAD) diagnosis', 'total costs of diagnosis', 'CAD diagnosis costs', 'entire diagnostic and therapeutic episode of care']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085554', 'cui_str': 'Patient Care Episodes'}]",120.0,0.0749229,"The total cost of coronary artery disease (CAD) diagnosis was significantly lower in the CCTA group as compared to the direct invasive coronary angiography (ICA) group ($50,176 vs $137,032) with corresponding per-patient cost of $836 vs $2,284, respectively.","[{'ForeName': 'Piotr Nikodem', 'Initials': 'PN', 'LastName': 'Rudziński', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland. Electronic address: piotr.rudzinski@ikard.pl.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kępka', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA; Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Otani', 'Affiliation': 'Siemens Healthcare K.K., Tokyo, Japan.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Leonard', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Dębski', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Dzielińska', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Pręgowski', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Witkowski', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Rużyłło', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Institute of Cardiology in Warsaw, Poland.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.07.008']
510,31391133,Feasibility of conducting an early pregnancy diet and lifestyle e-health intervention: the Pregnancy Lifestyle Activity Nutrition (PLAN) project.,"BACKGROUND


Childhood obesity is a global issue. Excessive weight gain in early pregnancy is independently associated with obesity in the next generation. Given the uptake of e-health, our primary aim was to pilot the feasibility of an e-health intervention, starting in the first trimester, to promote healthy lifestyle and prevent excess weight gain in early pregnancy. Methods: Women were recruited between 8 and 11 weeks gestation and randomised to the intervention or routine antenatal care. The intervention involved an e-health program providing diet, physical activity and well-being advice over 12 weeks.
RESULTS


Women (n = 57, 43.9% overweight/obese) were recruited at 9.38 ± 1.12 (control) and 9.06 ± 1.29 (intervention) weeks' gestation, mainly from obstetric private practices (81.2%). Retention was 73.7% for the 12-week intervention, 64.9% at birth and 55.8% at 3 months after birth.No difference in gestational weight gain or birth size was detected. Overall treatment effect showed a mean increase in score ranking the perceived confidence of dietary change (1.2 ± 0.46, p = 0.009) and score ranking readiness to exercise (1.21 ± 0.51, p = 0.016) over the intervention. At 3 months, infants weighed less in the intervention group (5405 versus 6193 g, p = 0.008) and had a lower ponderal index (25.5 ± 3.0 versus 28.8 ± 4.0 kg/m3) compared with the control group.
CONCLUSION AND DISCUSSION


A lifestyle intervention starting in the first-trimester pregnancy utilising e-health mode of delivery is feasible. Future studies need strategies to target recruitment of participants of lower socio-economic status and ensure maximal blinding. Larger trials (using technology and focused on early pregnancy) are needed to confirm if decreased infant adiposity is maintained.",2020,No difference in gestational weight gain or birth size was detected.,"[""Women (n = 57, 43.9% overweight/obese) were recruited at 9.38 ± 1.12 (control) and 9.06 ± 1.29 (intervention) weeks' gestation, mainly from obstetric private practices (81.2"", 'Women were recruited between 8 and 11 weeks gestation and randomised to the']","['intervention or routine antenatal care', 'Pregnancy Lifestyle Activity Nutrition (PLAN', 'early pregnancy diet and lifestyle e-health intervention']","['score ranking the perceived confidence of dietary change', 'lower ponderal index', 'Excessive weight gain', 'gestational weight gain or birth size', 'Retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}, {'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.11977,No difference in gestational weight gain or birth size was detected.,"[{'ForeName': 'Rae-Chi', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Lawrie', 'Initials': 'L', 'LastName': 'Beilin', 'Affiliation': 'Medical School, The University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Neppe', 'Affiliation': 'Joondalup Health Campus, Shenton Ave, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Mackie', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Roffey', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Lisa Y', 'Initials': 'LY', 'LastName': 'Gibson', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""D'Vaz"", 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Christian', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, Hospital Avenue, Nedlands, Western Australia, Australia.'}]",Journal of developmental origins of health and disease,['10.1017/S2040174419000400']
511,31420647,Effect of Monthly High-Dose Vitamin D Supplementation on Acute Respiratory Infections in Older Adults: A Randomized Controlled Trial.,"BACKGROUND


Although adults with low vitamin D status are at increased risk of acute respiratory infection (ARI), randomized controlled trials of vitamin D supplementation have provided inconsistent results.
METHODS


We performed a randomized, double-blinded, placebo-controlled trial of 5110 adults aged 50-84 years. In 2011-2012, participants were randomized to an initial oral dose of 200 000 IU vitamin D3 followed by 100 000 IU monthly (n = 2558) or placebo (n = 2552) until late 2013 (median follow-up, 1.6 years). Participants reported upper and lower ARIs on monthly questionnaires. Cox models analyzed time to first ARI (upper or lower) by treatment group.
RESULTS


Participants' mean age was 66 years and 58% were male; 83% were of European/other ethnicity, with the rest Maori, Polynesian, or South Asian. Mean (SD) baseline blood 25-hydroxyvitamin D [25(OH)D] level was 63 (24) nmol/L; 25% were <50 nmol/L. In a random sample (n = 441), vitamin D supplementation increased mean 25(OH)D to 135 nmol/L at 3 years, while those on placebo remained at 63 nmol/L. During follow-up, 3737 participants reported ≥1 ARI: 74.1% in the vitamin D group versus 73.7% in the placebo group. The hazard ratio for vitamin D compared with placebo was 1.01 (95% CI, 0.94, 1.07). Similar results were seen in most subgroups, including those with baseline 25(OH)D <50 nmol/L and in analyses of the upper/lower components of the ARI outcome.
CONCLUSIONS


Monthly high-dose vitamin D supplementation does not prevent ARI in older adults with a low prevalence of profound vitamin D deficiency at baseline. Whether effects of daily or weekly dosing differ requires further study.
CLINICAL TRIALS REGISTRATION


Australian New Zealand Clinical Trials Registry, identifier ACTRN12611000402943.",2020,"The hazard ratio for vitamin D compared to placebo was 1.01 (95%CI, 0.94, 1.07).","['adults with low vitamin D status', 'older adults', ""Participants' mean age was 66 years and 58% were male; 83% were of European/Other ethnicity, with the rest Maori, Polynesian or South Asian"", '5,110 adults, aged 50-84 years', 'older adults with a low prevalence of profound vitamin D deficiency at baseline']","['vitamin D supplementation', 'vitamin D', 'placebo', 'vitamin D3 followed by 100,000 IU monthly (n=2,558) or placebo']","['hazard ratio for vitamin D', 'acute respiratory infections', 'Mean (SD) baseline blood', '25-hydroxyvitamin D (25OHD) level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0024770', 'cui_str': 'Maori (ethnic group)'}, {'cui': 'C0240790', 'cui_str': 'Polynesians (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3737.0,0.800118,"The hazard ratio for vitamin D compared to placebo was 1.01 (95%CI, 0.94, 1.07).","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Alistair W', 'Initials': 'AW', 'LastName': 'Stewart', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, United Kingdom.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of General Practice, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz801']
512,31451025,Sonographic visualization and cannulation of the axillary vein in two arm positions during mechanical ventilation: A randomized trial.,"BACKGROUND


Abduction of the arm has been used for ultrasound-guided infraclavicular axillary vein cannulation. We evaluated the influence of arm position on sonographic visualization and cannulation of the axillary vein in patients receiving mechanical ventilation.
METHODS


Sixty patients scheduled to undergo surgery under general anaesthesia with controlled mechanical ventilation were included in this prospective randomized study. The depth, size and distance of axillary vein to the pleura were recorded at three points: Point A, the most proximal part of the axillary vein visualized with adduction; Point A', Point A in abduction; and Point B, the most proximal part of axillary vein visualized in abduction. Cephalic movement of the clavicle at Point A' and the distance between Point A and Point B were noted. In Group A, cannulation was performed at Point A in the adducted arm and at Point B with the abducted arm in Group B after randomization.
RESULTS


Abduction moved the clavicle cephalad by 2.2 ± 0.6 cm and increased sonographic visualization of the axillary vein by 2.2 ± 0.5 cm in length, when compared with adduction. The distance from the vein to pleura was higher in Point A' (p < 0.001). No differences were found during cannulation in terms of first-pass success rate or number of attempts.
CONCLUSION


Abducted position moved the clavicle cephalad and allowed sonographic visualization of infraclavicular axillary vein approximately 2 cm more proximally than with the adducted arm, with a comparable rate of cannulation success.",2020,The distance from the vein to pleura was higher in Point A' (p < 0.001).,"['Sixty patients scheduled to undergo surgery under general anaesthesia with controlled mechanical ventilation', 'patients receiving mechanical ventilation']","['ultrasound-guided infraclavicular axillary vein cannulation', 'Sonographic visualization and cannulation of the axillary vein']","['sonographic visualization', 'depth, size and distance of axillary vein to the pleura']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0419012', 'cui_str': 'Controlled mandatory ventilation (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}, {'cui': 'C0032225', 'cui_str': 'Pleura'}]",60.0,0.0566213,The distance from the vein to pleura was higher in Point A' (p < 0.001).,"[{'ForeName': 'Sivashanmugam', 'Initials': 'S', 'LastName': 'T', 'Affiliation': 'Department of Anesthesiology & Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed-to-be University), Puducherry, India.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Kulandyan', 'Affiliation': 'Department of Anesthesiology & Critical Care, Meenakshi Mission Hospital and Research Centre, Madurai, India.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Velraj', 'Affiliation': 'Department of Anesthesiology & Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed-to-be University), Puducherry, India.'}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Murugesan', 'Affiliation': 'Department of Anesthesiology & Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed-to-be University), Puducherry, India.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology & Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed-to-be University), Puducherry, India.'}]",The journal of vascular access,['10.1177/1129729819869504']
513,31171589,Use of a Medical-Alert Accessory in CKD: A Pilot Study.,"BACKGROUND AND OBJECTIVES


Poor disease recognition may jeopardize the safety of CKD care. We examined safety events and outcomes in patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We recruited 350 patients with stage 2-5 predialysis CKD. The first (pilot) 108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices. The subsequent (observation) subcohort ( n =242) received usual care. All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2). Secondary outcomes included 50% GFR reduction, ESKD, and death. Cox proportional hazards assessed the association of the medical-alert accessory with outcomes.
RESULTS


Median follow-up of pilot and observation subcohorts were 52 (interquartile range, 44-63) and 37 (interquartile range, 27-47) months, respectively. The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively. The medical-alert accessory was associated with lower crude and adjusted rate of ESKD versus the observation group (hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.89; and hazard ratio, 0.38; 95% confidence interval, 0.16 to 0.94, respectively). The association of the medical-alert accessory with the composite endpoint of ESKD or 50% reduction GFR was variable over time but appeared to have an early benefit (up to 23 months) with its use. There was no significant difference in incidence of hospitalization, death, or a composite of all outcomes between medical-alert accessory users and the observational group.
CONCLUSIONS


The medical-alert accessory was not associated with incidence of safety events but was associated with a lower rate of ESKD relative to usual care.",2019,"The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively.","['All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2', '108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices', 'patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population', '350 patients with stage 2-5 predialysis CKD']",['usual care'],"['50% GFR reduction, ESKD, and death', 'incidence of hospitalization, death, or a composite of all outcomes', 'frequency of class 1 and class 2 safety events']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0581560', 'cui_str': 'Safety finding'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]",[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",350.0,0.03423,"The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively.","[{'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Farhy', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Clarissa Jonas', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Divisions of General Internal Medicine and.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Doerfler', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Wanda J', 'Initials': 'WJ', 'LastName': 'Fink', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhan', 'Affiliation': 'Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland; and.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Fink', 'Affiliation': 'Departments of Medicine and jfink@som.umaryland.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13531118']
514,32170453,Arthroscopic repair of partial-thickness articular surface rotator cuff tears: single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation: results from a prospective randomized study.,"BACKGROUND


The purpose of this prospective study was to compare the clinical and structural findings following the arthroscopic repair of partial-thickness (exceeding 50%) articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation.
MATERIALS AND METHODS


Fifty patients were included in this study. The patients were randomly placed into two groups: 25 underwent the single-row (Group I) and 25 a double-row suture bridge fixation (Group II). The clinical outcomes were assessed using ASES and Constant shoulder scores, both preoperatively and at the end of follow-up. The pain level was evaluated using the visual analogue scale (VAS), preoperatively, at 6 months and at the end of follow-up. All patients underwent preoperative MRI to identify the rotator cuff tear, and postoperatively at 12 months to evaluate tendon integrity.
RESULTS


The average follow-up was 32.5 months. The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II. There were no significant differences between the two groups. The average preoperative pain level decreased from 7.4 to 3 at 6 months and to 0.4 at the end of the Group I; and from 7.6 to 3 at 6 months and 0.8 in Group II. There was no significant difference between the two groups. At 12 months, the MRI assessments showed two retears in Group I (8%) and one retear in Group II (4%).
CONCLUSION


Arthroscopic repair of partial-thickness articular rotator cuff tears that exceed 50% of tendon thickness with a single-row transtendon repair or double-row suture bridge provides functional improvement and pain relief regardless of the repair technique used. There were no differences in clinical results between both techniques.
LEVEL OF EVIDENCE


Level II; prospective comparative study.",2020,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"['arthroscopic repair of partial-thickness (exceeding 50', 'Fifty patients were included in this study']","['double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular rotator cuff tears', 'single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation', 'articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular surface rotator cuff tears']","['average preoperative pain level', 'MRI assessments', 'mean Constant shoulder scores', 'pain level', 'ASES and Constant shoulder scores', 'mean ASES scores', 'visual analogue scale (VAS']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",50.0,0.0221552,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zafra', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Uceda', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain. ucedasan@gmail.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Muñoz-Luna', 'Affiliation': 'Reina Sofía University Hospital, Avda. Menéndez Pidal, 14004, Córdoba, Spain.'}, {'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Muñoz-López', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Font', 'Affiliation': 'IMIBIC, Universidad de Córdoba, Córdoba, Spain.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03387-6']
515,32185660,Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial.,"PURPOSE


Middle-aged men are at high risk of suicide. While about half of those who kill themselves visit a primary care clinician (PCC) shortly before death, in current practice, few spontaneously disclose their thoughts of suicide during the visits, and PCCs seldom inquire about such thoughts. In a randomized controlled trial, we examined the effect of a tailored interactive computer program designed to encourage middle-aged men's discussion of suicide with PCCs.
METHODS


We recruited men 35-74 years old reporting recent (within 4 weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system. In the office before a visit, men viewed the intervention corresponding to their PCC's random group assignment: Men and Providers Preventing Suicide (MAPS) (20 PCCs), providing tailored multimedia promoting discussion of suicide thoughts, or control (22 PCCs), composed of a sleep hygiene video plus brief non-tailored text encouraging discussion of suicide thoughts. Logistic regressions, adjusting for patient nesting within physicians, examined MAPS' effect on patient-reported suicide discussion in the subsequent office visit.
RESULTS


Sixteen of the randomized PCCs had no patients enroll in the trial. From the panels of the remaining 26 PCCs (12 MAPS, 14 control), 48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9 years (SD 11.4). Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]). Logistic regression showed men viewing MAPS were more likely than controls to discuss suicide with their PCC (OR 5.91, 95% CI 1.59-21.94; P = 0.008; nesting-adjusted predicted effect 71% vs. 30%).
CONCLUSIONS


In addressing barriers to discussing suicide, the tailored MAPS program activated middle-aged men with active suicide thoughts to engage with PCCs around this customarily taboo topic.",2020,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"['Middle-Aged Men', 'Men and Providers Preventing Suicide (MAPS) (20 PCCs', ""middle-aged men's discussion of suicide with PCCs"", '48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9\xa0years (SD 11.4', 'Middle-aged men', 'Sixteen of the randomized PCCs', 'We recruited men 35-74\xa0years old reporting recent (within 4\xa0weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system']",['tailored interactive computer program'],['Suicide discussion'],"[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]",,0.0509858,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jerant', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. afjerant@ucdavis.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, 683 Hoes Lane West, Piscataway, NJ, 08854, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, UCD School of Medicine, 4150 V Street, Suite 2400, PSSB, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Cipri', 'Affiliation': 'Center for Healthcare Policy and Research, UCD, 2103 Stockton Blvd, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Franks', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05769-3']
516,31883847,Allergen-specific IgG +  memory B cells are temporally linked to IgE memory responses.,"BACKGROUND


IgE is the least abundant immunoglobulin and tightly regulated, and IgE-producing B cells are rare. The cellular origin and evolution of IgE responses are poorly understood.
OBJECTIVE


The cellular and clonal origin of IgE memory responses following mucosal allergen exposure by sublingual immunotherapy (SLIT) were investigated.
METHODS


In a randomized double-blind, placebo-controlled, time course SLIT study, PBMCs and nasal biopsy samples were collected from 40 adults with seasonal allergic rhinitis at baseline and at 4, 8, 16, 28, and 52 weeks. RNA was extracted from PBMCs, sorted B cells, and nasal biopsy samples for heavy chain variable gene repertoire sequencing. Moreover, mAbs were derived from single B-cell transcriptomes.
RESULTS


Combining heavy chain variable gene repertoire sequencing and single-cell transcriptomics yielded direct evidence of a parallel boost of 2 clonally and functionally related B-cell subsets of short-lived IgE +  plasmablasts and IgG +  memory B cells. Mucosal grass pollen allergen exposure by SLIT resulted in highly diverse IgE and IgG E  repertoires. These were extensively mutated and appeared relatively stable as per heavy chain isotype, somatic hypermutations, and clonal composition. Single IgG E +  memory B-cell and IgE +  preplasmablast transcriptomes encoded antibodies that were specific for major grass pollen allergens and able to elicit basophil activation at very low allergen concentrations.
CONCLUSION


For the first time, we have shown that on mucosal allergen exposure, human IgE memory resides in allergen-specific IgG +  memory B cells. These cells rapidly switch isotype, expand into short-lived IgE +  plasmablasts, and serve as a potential target for therapeutic intervention.",2020,"Single IgG E  + memory B cell and IgE+ pre-plasmablast transcriptomes encoded antibodies that were specific for major grass pollen allergens and were able to elicit basophil activation at very low allergen concentrations.
","['forty adults with seasonal allergic rhinitis at baseline, 4, 8, 16, 28 and 52 weeks']","['placebo', 'SLIT', 'sublingual immunotherapy (SLIT']",['peripheral blood mononuclear cells (PBMCs) and nasal biopsies'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0176358', 'cui_str': 'Biopsy of nose (procedure)'}]",40.0,0.206508,"Single IgG E  + memory B cell and IgE+ pre-plasmablast transcriptomes encoded antibodies that were specific for major grass pollen allergens and were able to elicit basophil activation at very low allergen concentrations.
","[{'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Hoof', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Schulten', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Layhadi', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stranzl', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Christensen', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Herrera de la Mata', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Seumois', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Pandurangan', 'Initials': 'P', 'LastName': 'Vijayanand', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lundegaard', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Niss', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Ahrenfeldt', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Holm', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Steveling', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Hanisah', 'Initials': 'H', 'LastName': 'Sharif', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Peters', 'Affiliation': 'La Jolla Institute for Immunology, La Jolla, Calif.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Andersen', 'Affiliation': 'ALK-Abelló A/S, Hørsholm, Denmark. Electronic address: PeterSejer.Andersen@alk.net.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.11.046']
517,31915189,Effects of acute sleep loss on diurnal plasma dynamics of CNS health biomarkers in young men.,"OBJECTIVE


Disrupted sleep increases CSF levels of tau and β-amyloid (Aβ) and is associated with an increased risk of Alzheimer disease (AD). Our aim was to determine whether acute sleep loss alters diurnal profiles of plasma-based AD-associated biomarkers.
METHODS


In a 2-condition crossover study, 15 healthy young men participated in 2 standardized sedentary in-laboratory conditions in randomized order: normal sleep vs overnight sleep loss. Plasma levels of total tau (t-tau), Aβ40, Aβ42, neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP) were assessed using ultrasensitive single molecule array assays or ELISAs, in the fasted state in the evening prior to, and in the morning after, each intervention.
RESULTS


In response to sleep loss (+17.2%), compared with normal sleep (+1.8%), the evening to morning ratio was increased for t-tau ( p  = 0.035). No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10). The AD risk genotype rs4420638 did not significantly interact with sleep loss-related diurnal changes in plasma levels of Aβ40 or Aβ42 ( p  > 0.10). Plasma levels of Aβ42 (-17.1%) and GFAP (-12.1%) exhibited an evening to morning decrease across conditions ( p  < 0.05).
CONCLUSIONS


Our exploratory study suggests that acute sleep loss results in increased blood levels of t-tau. These changes provide further evidence that sleep loss may have detrimental effects on brain health even in younger individuals. Larger cohorts are warranted to delineate sleep vs circadian mechanisms, implications for long-term recurrent conditions (e.g., in shift workers), as well as interactions with other lifestyle and genetic factors.",2020,"No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10).","['15 healthy young men participated in 2 standardized sedentary in-laboratory conditions in randomized order', 'young men']",['normal sleep vs overnight sleep loss'],"['levels of Aβ40, Aβ42, NfL, or GFAP', 'evening to morning ratio', 'blood levels', 'normal sleep', 'sleep loss', 'Plasma levels of Aβ42', 'CSF levels of tau and β-amyloid ', 'risk of Alzheimer disease (AD', 'diurnal plasma dynamics of CNS health biomarkers', 'Plasma levels of total tau (t-tau), Aβ40, Aβ42, neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP', 'GFAP']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017626', 'cui_str': 'Glial Intermediate Filament Protein'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]",15.0,0.110715,"No changes between the sleep conditions were seen for levels of Aβ40, Aβ42, NfL, or GFAP (all  p  > 0.10).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'From the Departments of Neuroscience (C.B., J.C.) and Medical Sciences (J.C.), Uppsala University; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; and UK Dementia Research Institute at UCL (H.Z.), London, UK. jonathan.cedernaes@medsci.uu.se.'}]",Neurology,['10.1212/WNL.0000000000008866']
518,31932513,Interaction of serum vitamin B 12  and folate with  MTHFR  genotypes on risk of ischemic stroke.,"OBJECTIVE


We evaluated the interaction of serum folate and vitamin B 12  with methylenetetrahydrofolate reductase ( MTHFR ) C677T genotypes on the risk of first ischemic stroke and on the efficacy of folic acid treatment in prevention of first ischemic stroke.
METHODS


A total of 20,702 hypertensive adults were randomized to a double-blind treatment of daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone. Participants were followed up every 3 months.
RESULTS


Median values of folate and B 12  concentrations at baseline were 8.1 ng/mL and 280.2 pmol/L, respectively. Over a median of 4.5 years, among those not receiving folic acid, participants with baseline serum B 12  or serum folate above the median had a significantly lower risk of first ischemic stroke (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.57-0.96), especially in those with  MTHFR  677 CC genotype (wild-type) (HR, 0.49; 95% CI, 0.31-0.78). Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55). However, TT homozygotes responded better with both folate and B 12  levels above the median (HR, 0.28; 95% CI, 0.10-0.75).
CONCLUSIONS


The risk of first ischemic stroke was significantly higher in hypertensive patients with low levels of both folate and B 12 . Effect of folic acid treatment was greatest in patients with low folate and B 12  with the CC genotype, and with high folate and B 12  with the TT genotype.",2020,"Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55).","['20,702 hypertensive adults', 'hypertensive patients', 'patients with low folate and B 12  with the CC genotype, and with high folate and B 12  with the TT genotype']","['serum folate and vitamin B 12  with methylenetetrahydrofolate reductase ( MTHFR ) C677T genotypes', 'Folic acid', 'folic acid', 'daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone', 'enalapril', 'enalapril-folic acid', 'folic acid treatment', 'serum vitamin B 12  and folate with  MTHFR  genotypes']","['Median values of folate and B 12  concentrations', 'risk of first ischemic stroke']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate Reductase (NADPH2)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0986173', 'cui_str': 'Folic Acid 0.8 MG'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",677.0,0.0550573,"Folic acid treatment significantly reduced the risk of first ischemic stroke in participants with both folate and B 12  below the median (2.3% in enalapril-folic acid group vs 3.6% in enalapril-only group; HR, 0.62; 95% CI, 0.46-0.86), particularly in  MTHFR  677 CC carriers (1.6% vs 4.9%; HR, 0.24; 95% CI, 0.11-0.55).","[{'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Lianyou', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.""}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD. huoyong@263.net.cn xipingxu126@126.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': ""From Renal Division (X.Q., Y.L., M.L., Y.Z., X.X.), Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease (X.Q., Y.L., M.L., Y.Z., X.X.); State Key Laboratory for Organ Failure Research (X.Q., Y.L., M.L., Y.Z., X.X.), Guangzhou, China; Stroke Prevention and Atherosclerosis Research Centre (J.D.S.), Robarts Research Institute, University of Western Ontario, London, Canada; Department of Cardiology (J.L., Y.Z., Y.H.), Peking University First Hospital; Department of Cardiology (N.S.), Peking University People's Hospital; Beijing Advanced Innovation Center for Food Nutrition and Human Health (Y.S.), Key Laboratory of Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing; Institute for Biomedicine (B.W.), Anhui Medical University, Hefei; Department of Cardiology (X.C.), Second Affiliated Hospital, Nanchang University; Department of Cardiology (L.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, China; and Department of Population, Family and Reproductive Health (X.W.), Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD. huoyong@263.net.cn xipingxu126@126.com.""}]",Neurology,['10.1212/WNL.0000000000008932']
519,32176191,"Personalized eHealth Program for Life-style Change: Results From the ""Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)"" Randomized Controlled Trial.","OBJECTIVE


Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time.
METHODS


Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the ""Do CHANGE 2"" or ""care as usual"" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis.
RESULTS


Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible.
CONCLUSIONS


The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT03178305.",2020,"For quality of life, no significant main effect (F(1,138.18)=.58, p=.447) or interaction effect (F(2,133.1)=0.41, p=.67) were found.","['cardiac patients', 'Cardiac patients and health care providers', 'Cardiac patients (N=150; mean age=61.97±11.61 years; 28.7% women; heart failure N=33, coronary artery disease N=50, hypertension N=67) recruited from Spain and The Netherlands']","['ambulatory health-behaviour assessment technologies', 'Personalized eHealth Program']","['lifestyle', 'quality of life', '1) lifestyle, and 2) quality of life over time', 'lifestyle behaviour']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0034380'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.111944,"For quality of life, no significant main effect (F(1,138.18)=.58, p=.447) or interaction effect (F(2,133.1)=0.41, p=.67) were found.","[{'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Broers', 'Affiliation': 'From the Department of Medical and Clinical Psychology, Tilburg University, and Center of Research on Psychology in Somatic diseases (CoRPS) (Broers, Widdershoven, Denollet, Lodder, Kop, Habibović); Department of Cardiology (Broers, Widdershoven, Habibović), Elisabeth-TweeSteden Hospital, Tilburg; Department of Industrial Design (Wetzels, Ayoola), Eindhoven University of Technology, Eindhoven; Onmi (Ayoola), Eindhoven, the Netherlands; and Badalona Serveis Assistencials (Piera-Jimenez), Badalona, Spain.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Widdershoven', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lodder', 'Affiliation': ''}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': ''}, {'ForeName': 'Mart', 'Initials': 'M', 'LastName': 'Wetzels', 'Affiliation': ''}, {'ForeName': 'Idowu', 'Initials': 'I', 'LastName': 'Ayoola', 'Affiliation': ''}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jimenez', 'Affiliation': ''}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibović', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000802']
520,32176193,Hyperventilation as a Predictor of Blood Donation-Related Vasovagal Symptoms.,"OBJECTIVE


Most of the research on vasovagal reactions has focused on the contributions of cardiovascular activity to the development of symptoms. However, other research suggests that additional mechanisms like hyperventilation may contribute to the process. The goal of the present investigation was to examine the influences of cardiovascular and respiratory variables on vasovagal symptoms.
METHODS


This study was part of a randomized controlled trial investigating the effects of behavioral techniques on the prevention of vasovagal reactions in blood donors. Data from the no-treatment control group were analyzed. The final sample was composed of 160 college and university students. Observational and self-report measures of symptoms were obtained. Physiological variables were measured mainly using respiratory capnometry.
RESULTS


Although respiration rate remained stable throughout donation, change in end-tidal carbon dioxide was associated with requiring treatment for a reaction during donation (odds ratio = 0.57, 95% confidence interval [CI] = 0.41 to 0.79, p = .001) and self-reported symptoms measured in the postdonation period using the Blood Donation Reactions Inventory (β = -0.152, 95% CI = -0.28 to -0.02, t = -2.32, p = .022). Individuals with higher levels of predonation anxiety displayed larger decreases in end-tidal carbon dioxide throughout the procedure (F(2,236) = 3.64, p = .043, ηp = 0.030). Blood Donation Reactions Inventory scores were related to changes in systolic (β = -0.022, 95% CI = -0.04 to -0.004, t = -2.39, p = .019) and diastolic blood pressure (β = -0.038, 95% CI = -0.06 to -0.02, t = -4.03, p < .001).
CONCLUSIONS


Although the vasovagal reaction has traditionally been viewed as a primarily cardiovascular event, the present results suggest that hyperventilation also plays a role in the development of vasovagal symptoms.",2020,"BDRI scores were related to changes in systolic (β=-.022, 95% CI= -.04- -.004, t=-2.39, p=.019) and diastolic blood pressure (β=-.038, 95% CI= -.06- -.02, t=-4.03, p <.001).
","['160 college and university students', 'blood donors']",['behavioral techniques'],"['vasovagal reactions', 'Blood Donation-Related Vasovagal Symptoms', 'Blood Donation Reactions Inventory', 'BDRI scores', 'respiration rate', 'diastolic blood pressure', 'end-tidal CO2']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C4316802', 'cui_str': 'Blood donation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424535', 'cui_str': 'Vasovagal symptom (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}]",,0.0753601,"BDRI scores were related to changes in systolic (β=-.022, 95% CI= -.04- -.004, t=-2.39, p=.019) and diastolic blood pressure (β=-.038, 95% CI= -.06- -.02, t=-4.03, p <.001).
","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Mennitto', 'Affiliation': 'From the Department of Psychology (Mennitto, Ditto), McGill University, Montreal, Quebec, Canada; the Department of Psychology (Ritz), Southern Methodist University, Dallas, Texas; Héma-Québec (Robillard), Montreal, Quebec, Canada; and the Department of Psychology (France), Ohio University, Athens, Ohio.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ritz', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Robillard', 'Affiliation': ''}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': ''}, {'ForeName': 'Blaine', 'Initials': 'B', 'LastName': 'Ditto', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000800']
521,32185573,Topical tranexamic acid in cemented primary total knee arthroplasty without tourniquet: a prospective randomized study.,"PURPOSE


Tranexamic acid (TXA) has been shown to be effective in reducing blood loss after total knee replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use, to reduce blood loss after primary total knee replacement without tourniquet, and to compare these outcomes with a control group that did not receive tranexamic acid.
METHODS


This is a prospective, randomized study to assess the effect of a 2-g topical tranexamic acid in 50 mL physiological saline solution in total knee replacement without tourniquet and drain. Primary outcomes were total blood loss. Secondary outcomes were hemoglobin and hematocrit level, hemoglobin and hematocrit drop, transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events.
RESULTS


Preoperative and intraoperative data were similar between the two groups. The mean total blood loss was 620 mL in the topical tranexamic acid group and 1094 mL in the control group with significant differences (p = 0.001), which meant 43% reduction in total blood loss. The hemoglobin and hematocrit postoperative value was significantly higher in the topical tranexamic acid group than in the control group (p = 0.002). Transfusion rates were 0% in the topical tranexamic group and 4.3% in the control group. The length of stay was significantly lower in the topical tranexamic acid group (p = 0.01). There were no DVT or PE in any group.
CONCLUSION


A single dose of 2-g TXA in 50 mL topical administration significantly reduces blood loss and improves postoperative blood chemistries in patients undergoing unilateral primary cemented TKA without tourniquet and drain compared to a control group, without increasing the risk of thromboembolic complications.",2020,The hemoglobin and hematocrit postoperative value was significantly higher in the topical tranexamic acid group than in the control group (p = 0.002).,"['total knee replacement without tourniquet and drain', 'group and 1094', 'patients undergoing unilateral primary cemented', 'cemented primary total knee arthroplasty without tourniquet']","['topical tranexamic acid', '2-g topical tranexamic acid', 'Topical tranexamic acid', 'Tranexamic acid (TXA', 'TXA', 'topical tranexamic', 'TKA', 'tranexamic acid', 'topical TXA']","['mean total blood loss', 'risk of thromboembolic complications', 'hemoglobin and hematocrit postoperative value', 'total blood loss', 'postoperative blood chemistries', 'length of stay', 'Transfusion rates', 'DVT or PE', 'hemoglobin and hematocrit level, hemoglobin and hematocrit drop, transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events', 'blood loss']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.135684,The hemoglobin and hematocrit postoperative value was significantly higher in the topical tranexamic acid group than in the control group (p = 0.002).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Morales Santias', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Mas Martinez', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanz-Reig', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain. jsanz@traumavist.com.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Martínez Gimenez', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Verdu Román', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bustamante Suarez de Puga', 'Affiliation': 'Knee Unit, Department of Orthopedic Surgery, HLA Clinica Vistahermosa, Av de Denia 76, 03016, Alicante, Spain.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02656-9']
522,30842540,Ultrafine particles and ozone perturb norepinephrine clearance rather than centrally generated sympathetic activity in humans.,"Cardiovascular risk rapidly increased following exposure to air pollution. Changes in human autonomic regulation have been implicated based on epidemiological associations between exposure estimates and indirect autonomic nervous system measurements. We conducted a mechanistic study to test the hypothesis that, in healthy older individuals, well-defined experimental exposure to ultrafine carbon particles (UFP) increases sympathetic nervous system activity and more so with added ozone (O 3 ). Eighteen participants (age >50 years, 6 women) were exposed to filtered air (Air), UFP, and UFP + O 3  combination for 3 hours during intermittent bicycle ergometer training in a randomized, crossover, double-blind fashion. Two hours following exposure, respiration, electrocardiogram, blood pressure, and muscle sympathetic nerve activity (MSNA) were recorded at supine rest, during deep breathing, and during a Valsalva manoeuvre. Catechols and inflammatory marker levels were measured in venous blood samples. Induced sputum was obtained 3.5 h after exposure. Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes. Norepinephrine was modestly increased while the ratio between plasma dihydroxyphenylglycol (DHPG) and norepinephrine levels, a marker for norepinephrine clearance, was reduced with UFP + O 3 . Resting MSNA was not different (47 ± 12 with Air, 47 ± 14 with UFP, and 45 ± 14 bursts/min with UFP + O 3 ). Indices of parasympathetic heart rate control were unaffected by experimental air pollution. Our study suggests that combined exposure to modest UFP and O 3  levels increases peripheral norepinephrine availability through decreased clearance rather than changes in central autonomic activity. Pulmonary inflammatory response may have perturbed pulmonary endothelial norepinephrine clearance.",2019,"Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes.","['healthy older individuals', 'humans', 'Eighteen participants (age >50 years, 6 women']","['filtered air (Air), UFP, and UFP\u2009+\u2009O 3  combination for 3\u2009hours during intermittent bicycle ergometer training', 'Norepinephrine', 'ultrafine carbon particles (UFP']","['Induced sputum', 'respiration, electrocardiogram, blood pressure, and muscle sympathetic nerve activity (MSNA', 'plasma dihydroxyphenylglycol (DHPG) and norepinephrine levels, a marker for norepinephrine clearance', 'sputum neutrophils and circulating leucocytes', 'Catechols and inflammatory marker levels', 'Cardiovascular risk']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0077801', 'cui_str': 'Ultrafine'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}]","[{'cui': 'C3179346', 'cui_str': 'Sputum, Induced'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0007413', 'cui_str': 'o-Dihydroxybenzenes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.026781,"Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes.","[{'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Heusser', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Holz', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'May', 'Affiliation': 'MHH CRC Core Facility & Centre for Pharmacology and Toxicology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Institute for Clinical Pharmacology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Engeli', 'Affiliation': 'Institute for Clinical Pharmacology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Autonomic Dysfunction Center, Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Framke', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Jan Danser', 'Affiliation': 'Division of Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, 3015 GE, Rotterdam, The Netherlands.'}, {'ForeName': 'Fred C G J', 'Initials': 'FCGJ', 'LastName': 'Sweep', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Centre, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'MHH CRC Core Facility & Centre for Pharmacology and Toxicology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schwarz', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Krug', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany. jens.jordan@dlr.de.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}]",Scientific reports,['10.1038/s41598-019-40343-w']
523,31996555,Suture-method versus Through-the-needle Catheters for Continuous Popliteal-sciatic Nerve Blocks: A Randomized Clinical Trial.,"BACKGROUND


The basic perineural catheter design has changed minimally since inception, with the catheter introduced through or over a straight needle. The U.S. Food and Drug Administration recently cleared a novel perineural catheter design comprising a catheter attached to the back of a suture-shaped needle that is inserted, advanced along the arc of its curvature pulling the catheter past the target nerve, and then exited through the skin in a second location. The authors hypothesized that analgesia would be noninferior using the new versus traditional catheter design in the first two days after painful foot/ankle surgery with a primary outcome of average pain measured with the Numeric Rating Scale.
METHODS


Subjects undergoing painful foot or ankle surgery with a continuous supraparaneural popliteal-sciatic nerve block 5 cm proximal to the bifurcation were randomized to either a suture-type or through-the-needle catheter and subsequent 3-day 0.2% ropivacaine infusion (basal 6 ml/h, bolus 4 ml, lockout 30 min). Subjects received daily follow-up for the first four days after surgery, including assessment for evidence of malfunction or dislodgement of the catheters.
RESULTS


During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001). No suture-style catheter was completely dislodged (0%), whereas the tips of three (9%) traditional catheters were found outside of the skin before purposeful removal on postoperative day 3 (P = 0.239).
CONCLUSIONS


Suture-type perineural catheters provided noninferior analgesia compared with traditional catheters for continuous popliteal-sciatic blocks after painful foot and ankle surgery. The new catheter design appears to be a viable alternative to traditional designs used for the past seven decades.",2020,"During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001).","['Continuous Popliteal-sciatic Nerve Blocks', 'Subjects undergoing painful foot or ankle surgery with a continuous supraparaneural popliteal-sciatic nerve block 5 cm proximal to the bifurcation']","['Suture-type perineural catheters provided noninferior analgesia', 'traditional catheters', 'Suture-method versus Through-the-needle Catheters', 'suture-type or through-the-needle catheter and subsequent 3-day 0.2% ropivacaine infusion']","['suture-style catheter', 'average pain', 'mean ± SD average pain scores']","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal (qualifier value)'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve (procedure)'}, {'cui': 'C0857248', 'cui_str': 'Painful feet'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0491233', 'cui_str': 'Needle catheter (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0657825,"During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001).","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran', 'Affiliation': 'From the Departments of Anesthesiology (J.J.F., M.W.S., R.A.G., E.T.S., M.U.A., W.B.A., B.M.I.) Orthopedic Surgery (D.J.D., A.K.S., W.T.K.), University of California San Diego, San Diego, California Outcomes Research Consortium, Cleveland, Ohio (J.J.F., M.W.S., R.A.G., D.Y., E.J.M., B.M.I.) Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.Y., E.J.M.).'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Swisher', 'Affiliation': ''}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Gabriel', 'Affiliation': ''}, {'ForeName': 'Engy T', 'Initials': 'ET', 'LastName': 'Said', 'Affiliation': ''}, {'ForeName': 'Maryann U', 'Initials': 'MU', 'LastName': 'Abanobi', 'Affiliation': ''}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Abramson', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dalstrom', 'Affiliation': ''}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Kent', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003145']
524,32173650,T-Cell Infiltration and Adaptive Treg Resistance in Response to Androgen Deprivation With or Without Vaccination in Localized Prostate Cancer.,"PURPOSE


Previous studies suggest that androgen deprivation therapy (ADT) promotes antitumor immunity in prostate cancer. Whether a vaccine-based approach can augment this effect remains unknown.
PATIENTS AND METHODS


We conducted a neoadjuvant, randomized study to quantify the immunologic effects of a GM-CSF-secreting allogeneic cellular vaccine in combination with low-dose cyclophosphamide (Cy/GVAX) followed by degarelix versus degarelix alone in patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy.
RESULTS


Both Cy/GVAX plus degarelix and degarelix alone led to significant increases in intratumoral CD8 +  T-cell infiltration and PD-L1 expression as compared with a cohort of untreated, matched controls. However, the CD8 +  T-cell infiltrate was accompanied by a proportional increase in regulatory T cells (Treg), suggesting that adaptive Treg resistance may dampen the immunogenicity of ADT. Although Cy/GVAX followed by degarelix was associated with a modest improvement in time-to-PSA progression and time-to-next treatment, as well as an increase in PD-L1, there was no difference in the CD8 +  T-cell infiltrate as compared with degarelix alone. Gene expression profiling demonstrated that  CHIT1 , a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared with degarelix alone.
CONCLUSIONS


Our results highlight that ADT with or without Cy/GVAX induces a complex immune response within the prostate tumor microenvironment. These data have important implications for combining ADT with immunotherapy. In particular, our finding that ADT increases both CD8 +  T cells and Tregs supports the development of regimens combining ADT with Treg-depleting agents in the treatment of prostate cancer.",2020,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone.
","['prostate cancer', 'patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy', 'Localized Prostate Cancer']","['Androgen Deprivation', 'granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting allogeneic cellular vaccine', 'degarelix versus degarelix alone', 'cyclophosphamide (Cy/GVAX', 'ADT with or without Cy/GVAX', 'androgen deprivation therapy (ADT']","['PD-L1', 'CD8 T-cell infiltrate', 'time-to-PSA progression and time-to-next treatment', 'intratumoral CD8+ T cell infiltration and PD-L1 expression']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.02347,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone.
","[{'ForeName': 'Aleksandar Z', 'Initials': 'AZ', 'LastName': 'Obradovic', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Dallos', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Marianna L', 'Initials': 'ML', 'LastName': 'Zahurak', 'Affiliation': 'Department of Oncology and Biostatistics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Texas Urology Specialists, Dallas, Texas.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Nirschl', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Maryland.'}, {'ForeName': 'Carolyn G', 'Initials': 'CG', 'LastName': 'Chapman', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': ""O'Neal"", 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Guner', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Baena-Del Valle', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ertunc', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York. cgd2139@cumc.columbia.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3372']
525,31977520,"Dexamethasone Dose and Early Postoperative Recovery after Mastectomy: A Double-blind, Randomized Trial.","BACKGROUND


Pain and nausea are the most common challenges in postoperative recovery after mastectomy. Preventive measures include multimodal analgesia with preoperative glucocorticoid. The aim of this study was to investigate whether 24 mg of preoperative dexamethasone was superior to 8 mg on early recovery after mastectomy in addition to a simple analgesic protocol.
METHODS


In a randomized, double-blind trial, patients 18 yr of age or older having mastectomy were randomized 1:1 to 24 mg or 8 mg dexamethasone, and all received a standardized anesthetic and surgical protocol with preoperative acetaminophen, total intravenous anesthesia, and local anesthetic wound infiltration. The primary endpoint was number of patients transferred to the postanesthesia care unit according to standardized discharge criteria (modified Aldrete score). Secondary endpoints included pain and nausea at extubation, transfer from the operating room and upon arrival at the ward, length of stay, seroma occurrence, and wound infections.
RESULTS


One hundred thirty patients (65 in each group) were included and analyzed for the primary outcome. Twenty-three (35%) in each group met the primary outcome, without significant differences in standardized discharge scores (odds ratio, 1.00 [95% CI, 0.49 to 2.05], P > 0.999). More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030). Median pain scores were low at all measured time points, numeric rating scale less than or equal to 2 versus less than or equal to 1 in the 24 mg versus 8 mg group, respectively. Six patients in each group (9%) experienced nausea at any time during hospital stay (P > 0.999). Length of stay was median 11 and 9.2 h in the 24 and 8 mg group, respectively (P = 0.217).
CONCLUSIONS


The authors found no evidence of 24 mg versus 8 mg of dexamethasone affecting the primary outcome regarding immediate recovery after mastectomy. The authors observed a short length of stay and low pain scores despite a simple analgesic protocol.",2020,"More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030).","['Mastectomy', 'patients 18 yr of age or older having mastectomy', 'One hundred thirty patients (65 in each group']","['dexamethasone', 'preoperative glucocorticoid', 'groupsDexamethasone', 'Dexamethasone', 'standardized anesthetic and surgical protocol with preoperative acetaminophen, total intravenous anesthesia, and local anesthetic wound infiltration', 'preoperative dexamethasone']","['short length of stay and low pain scores', 'number of patients transferred to the postanesthesia care unit according to standardized discharge criteria (modified Aldrete score', 'pain and nausea at extubation, transfer from the operating room and upon arrival at the ward, length of stay, seroma occurrence, and wound infections', 'standardized discharge scores', 'Pain and nausea', 'nausea at any time during hospital stay', 'Median pain scores', 'Length of stay', 'immediate recovery', 'seroma requiring drainage']","[{'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030704', 'cui_str': 'Patient Transfer'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]",130.0,0.497911,"More patients had seroma requiring drainage in the 24 mg versus 8 mg group, 94% versus 81%, respectively (odds ratio, 3.53 [95% CI, 1.07 to 11.6], P = 0.030).","[{'ForeName': 'Kristin Julia', 'Initials': 'KJ', 'LastName': 'Steinthorsdottir', 'Affiliation': 'From the Department of Anesthesiology, Centre for Cancer and Organ Diseases (K.J.S., H.N.A., E.K.A.) Surgical Pathophysiology Unit (K.J.S., H.K.) Department of Anesthesiology, Centre of Head and Orthopaedics (H.A.), Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark Department of Breast Surgery, Herlev/Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (N.K.).'}, {'ForeName': 'Hussein Nasser', 'Initials': 'HN', 'LastName': 'Awada', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Abildstrøm', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Kroman', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': ''}, {'ForeName': 'Eske', 'Initials': 'E', 'LastName': 'Kvanner Aasvang', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003112']
526,32175988,Internal carotid artery blood flow is enhanced by elevating blood pressure during combined propofol-remifentanil and thoracic epidural anaesthesia: A randomised cross-over trial.,"BACKGROUND


Anaesthesia reduces mean arterial pressure (MAP), and to preserve organ perfusion, vasopressors are often used to maintain MAP above 60 mmHg. Cognitive dysfunction is common following major surgery and may relate to intra-operative cerebral hypoperfusion.
OBJECTIVE


The aim of this study was to evaluate whether internal carotid artery (ICA) blood flow increases when MAP is kept higher than 60 mmHg using noradrenaline.
DESIGN


A randomised, cross-over trial.
SETTING


Department of Anaesthesia, Rigshospitalet, Copenhagen, Denmark, from December 2017 to April 2018.
PATIENTS


Patients with median [IQR] age 71 [63 to 75] years underwent pancreaticoduodenectomy (n = 19), total pancreatic resection (n = 1) or gastro-entero anastomosis (n = 2) during combined propofol-remifentanil and thoracic epidural anaesthesia.
INTERVENTION


MAP was maintained between 60 to 65, 70 to 75 and 80 to 85 mmHg, in a random order, by noradrenaline infusion at a stable level of anaesthesia.
MAIN OUTCOME MEASURES


Primary outcome was change in ICA flow at MAP 60 to 65 vs. 80 to 85 mmHg. Secondary outcomes were change in ICA flow at MAP 60 to 65 vs. 70 to 75 and 70 to 75 vs. 80 to 85 mmHg. Duplex ultrasound evaluated ICA flow.
RESULTS


A (mean ± SD) increase in MAP from 62 ± 1 to 82 ± 1 mmHg elevated ICA flow from 196 ± 53 to 226 ± 61 ml min (mean difference 31 ml min; 95% CI 19 to 42; P < 0.0001). An increase in MAP from 62 ± 1 to 72 ± 1 mmHg elevated ICA flow to 210 ± 52 ml min (P = 0.0271) and ICA flow increased further (P = 0.0165) when MAP was elevated to 82 ± 1 mmHg.
CONCLUSION


During combined propofol-remifentanil and thoracic epidural anaesthesia, ICA flow increased by approximately 15% when the MAP was elevated from about 60 to 80 mmHg. Treatment of a reduction in MAP brought about by anaesthesia seems to enhance ICA flow.
TRIAL REGISTRATION


Clinicaltrials.gov ID: NCT03309917.",2020,"min (P = 0.0271) and ICA flow increased further (P = 0.0165) when MAP was elevated to 82 ± 1 mmHg.
","['53 to 226\u200a±', 'Department of Anaesthesia, Rigshospitalet, Copenhagen, Denmark, from December 2017 to April 2018', 'Patients with median [IQR] age 71 [63 to 75] years underwent']","['total pancreatic resection (n\u200a=\u200a1) or gastro-entero anastomosis', 'noradrenaline infusion', 'propofol-remifentanil and thoracic epidural anaesthesia', 'propofol-remifentanil', 'pancreaticoduodenectomy']","['mean arterial pressure (MAP', 'ICA flow', 'blood pressure', 'change in ICA flow', 'internal carotid artery (ICA) blood flow']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.0837332,"min (P = 0.0271) and ICA flow increased further (P = 0.0165) when MAP was elevated to 82 ± 1 mmHg.
","[{'ForeName': 'Niels D', 'Initials': 'ND', 'LastName': 'Olesen', 'Affiliation': 'From the Department of Anaesthesia, Rigshospitalet (NDO, HJF, NVO, NHS), Department of Biomedical Sciences (NDO, NVO), Department of Surgical Gastroenterology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (JHS, CPH, LBS).'}, {'ForeName': 'Hans-Jørgen', 'Initials': 'HJ', 'LastName': 'Frederiksen', 'Affiliation': ''}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Storkholm', 'Affiliation': ''}, {'ForeName': 'Carsten P', 'Initials': 'CP', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Lars B', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': ''}, {'ForeName': 'Niels V', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001189']
527,31889358,"Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study.","AIM AND OBJECTIVES


Virtual reality (VR) can be used during painful procedures in children. The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety of children aged 5-12 years old during blood draw.
METHODS


This randomised controlled study used parallel trial design guided by the CONSORT checklist, see Supporting Information. The sample of children (n = 136) was allocated to the VR-Rollercoaster (n = 45), VR-Ocean Rift (n = 45) and control group (n = 46) using blocked randomisation. The primary outcome was pain scores after the blood draw and fear and anxiety scores before and after the blood draw. Before the blood draw, fear and anxiety scores were assessed using self-report and reports from the parents and the researcher using the Child Fear Scale and Children's Anxiety Meter. After the blood draw, level of pain experienced was assessed using the Wong-Baker Faces Pain Rating Scale and the fear and anxiety levels experienced by the children during the blood draw were re-evaluated.
RESULTS


Pain scores were found to be lower in the VR-Rollercoaster group and the VR-Ocean Rift group. A statistical difference was found between groups according to self-, parent- and researcher-reported fear and anxiety scores after blood draw. While being in VR-Rollercoaster and VR-Ocean Rift group reduced children's fear and anxiety, being in the control group increased fear levels by 20% and anxiety levels by 34.1%.
CONCLUSIONS


VR is an effective method in reducing procedure-related pain, fear and anxiety in children aged 5-12 years old during blood draw.
RELEVANCE TO CLINICAL PRACTICE


Evidence-based guidelines and protocols should be created for nonpharmacological methods such as VR for procedural pain and anxiety in children.",2020,"CONCLUSIONS


VR is an effective method in reducing procedure-related pain, fear and anxiety in children aged 5-12 years old during blood draw.
","['painful procedures in children', 'sample of children (n\xa0=\xa0136', 'children', 'children aged 5-12\xa0years old during blood draw', 'children aged 5-12 years old']","['virtual reality', 'VR-Ocean rift', 'VR-Rollercoaster']","['pain scores after the blood draw and fear and anxiety scores', ""children's fear and anxiety"", 'pain, fear and anxiety', 'fear and anxiety scores', 'Baker Faces Pain Rating Scale and the fear and anxiety levels', ""Child Fear Scale and Children's Anxiety Meter"", 'procedure-related pain, fear and anxiety', 'blood draw, fear and anxiety scores', 'fear levels', 'anxiety levels', 'Pain scores']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0028814', 'cui_str': 'Oceans'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}]",,0.0289906,"CONCLUSIONS


VR is an effective method in reducing procedure-related pain, fear and anxiety in children aged 5-12 years old during blood draw.
","[{'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Özalp Gerçeker', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, Turkey.'}, {'ForeName': 'Dijle', 'Initials': 'D', 'LastName': 'Ayar', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, Turkey.'}, {'ForeName': 'Emine Zahide', 'Initials': 'EZ', 'LastName': 'Özdemir', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bektaş', 'Affiliation': 'Pediatric Nursing Department, Dokuz Eylul University Faculty of Nursing, Izmir, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.15173']
528,32171183,Efficacy of kinesio taping in early stage breast cancer associated lymphedema: A randomized single blinded study.,"This study was designed to evaluate the effectiveness of kinesio taping compared to compression garment in treatment of early stage breast cancer-associated lymphedema (BCAL). Patients between 18-70-years old who had unilateral stage 1 BCAL were randomized into group I kinesio taping (KT) and group II compression garment (CG) for this single blinded study. KT was applied with a lymphatic correction technique in three-four day intervals for four weeks. At the end of the fourth week, patients were suggested to wear CGs. Patients in group II were treated daily for 23-hours in CGs. Education, preventive measures, and exercises were given to both groups. All patients were evaluated before the treatment (T0), immediate post treatment (T1), and three months after treatment (T2). Circumference differences were measured between the extremities with a nonelastic tape at five levels. Additionally, shoulder range of motion (ROM) was measured, and pain, heaviness, and sensation of tightness were evaluated with a visual analog scale (VAS). Thirty-five patients with stage 1 BCAL were included and randomized to the KT (n= 16) and CG (n= 19) groups. Demographic data and baseline clinical characteristics were similar. Both groups had reductions in all levels of arm circumference differences at immediate post-treatment and three months after treatment. Pain, tightness, and heaviness scores significantly decreased for both groups at immediate post-treatment and third month. Patients in the KT group had significantly lower pain sores than patients in the CG group. Results demonstrated that both modalities had similar effects in the treatment of early stage BCAL. For patients with early stage BCAL, KT can be an alternative treatment to CG for patients who have difficulties in obtaining and wearing CGs.",2019,Patients in the KT group had significantly lower pain sores than patients in the CG group.,"['Thirty-five patients with stage 1 BCAL', 'early stage breast cancer associated lymphedema', 'early stage breast cancer-associated lymphedema (BCAL', 'Patients between 18-70-years old who had unilateral stage 1 BCAL']","['kinesio taping (KT) and group II compression garment (CG', 'compression garment', 'kinesio taping']","['Pain, tightness, and heaviness scores', 'pain sores', 'pain, heaviness, and sensation of tightness', 'shoulder range of motion (ROM', 'Circumference differences', 'visual analog scale (VAS']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1455785', 'cui_str': 'Sore sensation quality'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",35.0,0.0504707,Patients in the KT group had significantly lower pain sores than patients in the CG group.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ozsoy-Unubol', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanal-Toprak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}]",Lymphology,[]
529,32171186,Inclusion of targeted skin products in the pre-surgical treatment regimen of peripheral lymphedema & lipedema.,"Advanced lymphedema is associated with a number of adverse skin changes including color, thickening of the epidermis, dryness, and hyperkeratosis. These changes are related to prolonged lymph stasis and contribute to an increased risk of infection. Similarly, lipedema is associated with skin thickening and appearance of nodular adipose deposition. Skin care is essential in both conditions. We examined whether inclusion of targeted skin products for 2 weeks to an established pre-surgical conservative treatment program was associated with beneficial effects on the skin condition in 150 patients with lymphedema and lipedema. Patients were randomly assigned to control or one of two treatment groups. All three groups (and for both lymphedema and lipedema) demonstrated a significant reduction in softness. Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema. Only patients with lipedema demonstrated a significant reduction in dryness/ hyperkeratosis following targeted skin product treatment. This study demonstrates that short-term use of targeted skin products in both patients with lymphedema and lipedema can be of benefit and further studies are needed to replicate these results and explore possible mechanisms.",2019,Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema.,"['patients with lymphedema and lipedema', 'peripheral lymphedema & lipedema', '150 patients with lymphedema and lipedema']",[],"['Dimpling/ redness', 'skin thickening and appearance of nodular adipose deposition', 'dryness/ hyperkeratosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0398370', 'cui_str': 'Lipoedemas'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]",[],"[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0241165', 'cui_str': 'Thick skin (finding)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}]",150.0,0.0155258,Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema.,"[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Campisi', 'Affiliation': 'Department of Plastic Surgery, University School of Catania, Sicily, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Harvey Medicine and Surgery Course, University of Pavia, Pavia, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'di Summa', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, University Hospital of Lausanne, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scarabosio', 'Affiliation': 'Medical Student, Campus BioMedico, Rome, Italy.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Campisi', 'Affiliation': 'Dermatology Section of Chirurgia Laser Genova Medical Center, Genoa, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Campisi', 'Affiliation': 'Lymphatic Surgery & Microsurgery, University of Genoa, School of Medical Sciences & Pharmaceutics, Department of Surgery, Genoa, Italy.'}]",Lymphology,[]
530,32199095,"Safety and efficacy of rituximab in neuromyelitis optica spectrum disorders (RIN-1 study): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND


Pharmacological prevention against relapses in patients with neuromyelitis optica spectrum disorder (NMOSD) is developing rapidly. We aimed to investigate the safety and efficacy of rituximab, an anti-CD20 monoclonal antibody, against relapses in patients with NMOSD.
METHODS


We did a multicentre, randomised, double-blind, placebo-controlled clinical trial at eight hospitals in Japan. Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study. Individuals taking any other immunosuppressants were excluded. Participants were randomly allocated (1:1) either rituximab or placebo by a computer-aided dynamic random allocation system. The doses of concomitant steroid (converted to equivalent doses of prednisolone) and relapses in previous 2 years were set as stratification factors. Participants and those assessing outcomes were unaware of group assignments. Rituximab (375 mg/m 2 ) was administered intravenously every week for 4 weeks, then 6-month interval dosing was done (1000 mg every 2 weeks, at 24 weeks and 48 weeks after randomisation). A matching placebo was administered intravenously. Concomitant oral prednisolone was gradually reduced to 2-5 mg/day, according to the protocol. The primary outcome was time to first relapse within 72 weeks. Relapses were defined as patient-reported symptoms or any new signs consistent with CNS lesions and attributable objective changes in MRI or visual evoked potential. The primary analysis was done in the full analysis set (all randomly assigned patients) and safety analyses were done in the safety analysis set (all patients who received at least one infusion of assigned treatment). The primary analysis was by intention-to-treat principles. This trial is registered with the UMIN clinical trial registry, UMIN000013453.
FINDINGS


Between May 10, 2014, and Aug 15, 2017, 38 participants were recruited and randomly allocated either rituximab (n=19) or placebo (n=19). Three (16%) patients assigned rituximab discontinued the study and were analysed as censored cases. Seven (37%) relapses occurred in patients allocated placebo and none were recorded in patients assigned rituximab (group difference 36·8%, 95% CI 12·3-65·5; log-rank p=0·0058). Eight serious adverse events were recorded, four events in three (16%) patients assigned rituximab (lumbar compression fracture and infection around nail of right foot [n=1], diplopia [n=1], and uterine cancer [n=1]) and four events in two (11%) people allocated to placebo (exacerbation of glaucoma and bleeding in the right eye chamber after surgery [n=1], and visual impairment and asymptomatic white matter brain lesion on MRI [n=1]); all patients recovered. No deaths were reported.
INTERPRETATION


Rituximab prevented relapses for 72 weeks in patients with NMOSD who were AQP4 antibody-positive. This study is limited by its small sample size and inclusion of participants with mild disease activity. However, our results suggest that rituximab could be useful maintenance therapy for individuals with NMOSD who are AQP4 antibody-positive.
FUNDING


Japanese Ministry of Health, Labour and Welfare, Japan Agency for Medical Research and Development, and Zenyaku Kogyo.",2020,"No deaths were reported.
","['neuromyelitis optica spectrum disorders (RIN-1 study', 'Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'individuals with NMOSD who are AQP4 antibody-positive', 'eight hospitals in Japan', 'Between May 10, 2014, and Aug 15, 2017, 38 participants', 'participants with mild disease activity', 'patients with NMOSD']","['concomitant steroid', 'Rituximab', 'rituximab or placebo', 'placebo', 'rituximab', 'prednisolone', 'Concomitant oral prednisolone']","['Safety and efficacy', 'Relapses', 'safety and efficacy', 'time to first relapse']","[{'cui': 'C0027873', 'cui_str': ""Devic's Neuromyelitis Optica""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C2919772', 'cui_str': 'Aquaporin-4 antibody'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",38.0,0.757995,"No deaths were reported.
","[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan. Electronic address: tahara.masayuki.ne@mail.hosp.go.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Oeda', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kiriyama', 'Affiliation': 'Department of Neurology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Ochi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hikoaki', 'Initials': 'H', 'LastName': 'Fukaura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Misu', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Umemura', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sawada', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30066-1']
531,32165550,mHealth: providing a mindfulness app for women with chronic pelvic pain in gynaecology outpatient clinics: qualitative data analysis of user experience and lessons learnt.,"OBJECTIVES


To determine whether a pre-existing smartphone app to teach mindfulness meditation is acceptable to women with chronic pelvic pain (CPP) and can be integrated into clinical practice within the National Health Service (NHS) CPP pathways, and to inform the design of a potential randomised clinical trial.
DESIGN


A prestudy patient and public involvement (PPI) group to collect feedback on the acceptability of the existing app and study design was followed by a three-arm randomised feasibility trial. In addition, we undertook interviews and focus groups with patients and staff to explore app usability and acceptability. We also obtained participant comments on the research process, such as acceptability of the study questionnaires.
SETTING


Two gynaecology clinics within Barts Health NHS, London, UK.
PARTICIPANTS


Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English.
INTERVENTION


The intervention was mindfulness meditation content plus additional pain module delivered by a smartphone app. Active controls received muscle relaxation content from the same app. Passive (waiting list) controls received usual care.
MAIN OUTCOME MEASURES


Themes on user feedback, app usability and integration, and reasons for using/not using the app.
RESULTS


The use of the app was low in both active groups. Patients in the prestudy PPI group, all volunteers, were enthusiastic about the app (convenience, content, portability, flexibility, ease of use). Women contributing to the interview or focus group data (n=14), from a 'real world' clinic (some not regular app users), were less positive, citing as barriers lack of opportunities/motivation to use the app and lack of familiarity and capabilities with technology. Staff (n=7) were concerned about the potential need for extra support for them and for the patients, and considered the app needed organisational backing and peer acceptance.
CONCLUSION


The opinions of prestudy PPI volunteers meeting in their private time may not represent those of patients recruited at a routine clinic appointment. It may be more successful to codesign/codevelop an app with typical users than to adapt existing apps for use in real-world clinical populations.
TRIAL REGISTRATION NUMBER


ISRCTN10925965.",2020,The use of the app was low in both active groups.,"['Two gynaecology clinics within Barts Health NHS, London, UK', 'Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English', 'women with chronic pelvic pain (CPP', 'women with chronic pelvic pain in gynaecology outpatient clinics']","['Passive (waiting list) controls received usual care', 'public involvement (PPI) group to collect feedback', 'mindfulness meditation content plus additional pain module delivered by a smartphone app', 'pre-existing smartphone app to teach mindfulness meditation']","['user feedback, app usability and integration, and reasons for using/not using the app', 'muscle relaxation content']","[{'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.0476217,The use of the app was low in both active groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ball', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Newton', 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rohricht', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute for Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': 'Pelvic Pain Support Network, Poole, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cantalapiedra Calvete', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'UCL Social Research Institute, University College London, London, UK c.rivas@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-030711']
532,32167131,Prospective clinical trial examining the impact of genetic variation in FADS1 on the metabolism of linoleic acid- and ɣ-linolenic acid-containing botanical oils.,"BACKGROUND


Unexplained heterogeneity in clinical trials has resulted in questions regarding the effectiveness of ɣ-linolenic acid (GLA)-containing botanical oil supplements. This heterogeneity may be explained by genetic variation within the fatty acid desaturase (FADS) gene cluster that is associated with circulating and tissue concentrations of arachidonic acid (ARA) and dihomo-ɣ-linolenic acid (DGLA), both of which may be synthesized from GLA and result in proinflammatory and anti-inflammatory metabolites, respectively.
OBJECTIVES


The objective of this study was to prospectively compare the capacity of a non-Hispanic white cohort, stratified by FADS genotype at the key single-nucleotide polymorphism (SNP) rs174537, to metabolize 18-carbon omega-6 (n-6) PUFAs in borage oil (BO) and soybean oil (SO) to GLA, DGLA, and ARA.
METHODS


Healthy adults (n = 64) participated in a randomized, double-blind, crossover intervention. Individuals received encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L.) Merr.; 50% LA and 0% GLA] for 4 wk, followed by an 8-wk washout period, before consuming the opposite oil for 4 wk. Serum lipids and markers of inflammation (C-reactive protein) were assessed for both oil types at baseline and during weeks 2 and 4 of the intervention.
RESULTS


SO supplementation failed to alter circulating concentrations of any n-6 long-chain PUFAs. In contrast, a modest daily dose of BO elevated serum concentrations of GLA and DGLA in an rs174537 genotype-dependent manner. In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals. For ARA, baseline concentrations varied substantially by genotype and increased modestly with BO supplementation, suggesting a key role for FADS variation in the balance of DGLA and ARA.
CONCLUSIONS


The results of this study clearly suggest that personalized and population-based approaches considering FADS genetic variation may be necessary to optimize the design of future clinical studies with GLA-containing oils. This trial was registered at clinicaltrials.gov as NCT02337231.",2020,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.",['Healthy adults (n\xa0=\xa064'],"['metabolize 18-carbon omega-6', 'n-6) PUFAs in borage oil (BO) and soybean oil (SO', 'acid- and ɣ-linolenic acid-containing botanical oils', 'linoleic', 'linolenic acid (GLA)-containing botanical oil supplements', 'encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L']","['DGLA', 'Serum lipids and markers of inflammation (C-reactive protein']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0212750', 'cui_str': 'starflower oil'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0522464', 'cui_str': 'Borage'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",64.0,0.454568,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sergeant', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hallmark', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rasika A', 'Initials': 'RA', 'LastName': 'Mathias', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Tammy L', 'Initials': 'TL', 'LastName': 'Mustin', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ivester', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Bohannon', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Ruczinski', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Johnstone', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Seeds', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Floyd H', 'Initials': 'FH', 'LastName': 'Chilton', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa023']
533,31905607,"Pre-Sleep Casein Protein Ingestion Does Not Impact Next-Day Appetite, Energy Intake and Metabolism in Older Individuals.","Maintaining adequate daily protein intake is important to maintain muscle mass throughout the lifespan. In this regard, the overnight period has been identified as a window of opportunity to increase protein intake in the elderly. However, it is unknown whether pre-sleep protein intake affects next-morning appetite and, consequently, protein intake. Therefore, the purpose of the current study was to investigate the effects of a pre-sleep protein drink on next-morning appetite, energy intake and metabolism. Twelve older individuals (eight males, four females; age: 71.3 ± 4.2 years) took part in a single-blind randomised cross-over study. After a standardised dinner, participants consumed either a 40-g protein drink, isocaloric maltodextrin drink, or placebo water control before bedtime. Next-morning appetite, energy intake, resting metabolic rate (RMR), respiratory exchange rate (RER), and plasma acylated ghrelin, leptin, glucose, and insulin concentrations were assessed. No between-group differences were observed for appetite and energy intake at breakfast. Furthermore, RMR, RER, and assessed blood markers were not significantly different between any of the treatment groups. Pre-sleep protein intake does not affect next-morning appetite and energy intake and is therefore a viable strategy to increase daily protein intake in an older population.",2019,sleep protein intake does not affect next-morning appetite and energy intake and is therefore a viable strategy to increase daily protein intake in an older population.,"['Older Individuals', 'Twelve older individuals (eight males, four females; age: 71.3 ± 4.2 years) took part in a single-blind randomised cross-over study']","['Casein Protein Ingestion', 'pre-sleep protein drink', '40-g protein drink, isocaloric maltodextrin drink, or placebo water control before bedtime']","['next-morning appetite, energy intake and metabolism', 'Next-morning appetite, energy intake, resting metabolic rate (RMR), respiratory exchange rate (RER), and plasma acylated ghrelin, leptin, glucose, and insulin concentrations', 'appetite and energy intake', 'Furthermore, RMR, RER, and assessed blood markers', 'Pre-Sleep']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005768'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",12.0,0.0324442,sleep protein intake does not affect next-morning appetite and energy intake and is therefore a viable strategy to increase daily protein intake in an older population.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morehen', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Smeuninx', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Perkins', 'Affiliation': 'Department of Sport and health Sciences, University of Exeter, Exeter EX1 2LU, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Breen', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham B15 2TT, UK.'}]",Nutrients,['10.3390/nu12010090']
534,31726485,Effects of continuous positive airway pressure on blood pressure in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES).,"Obstructive sleep apnea is associated with hypertension, and short-term studies have demonstrated a modest reduction in blood pressure with continuous positive airway pressure therapy. We evaluated the effects of continuous positive airway pressure versus sham continuous positive airway pressure on blood pressure in 1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study, a randomized, sham-controlled double-blinded study designed to assess the impact of continuous positive airway pressure on neurocognition. Participants with apnea-hypopnea index ≥ 10 were randomly assigned to continuous positive airway pressure or sham continuous positive airway pressure. Blood pressures measured in the morning and evening at baseline, 2 months and 6 months were analysed post hoc using a mixed-model repeated-measures analysis of variance. The largest magnitude reduction was approximately 2.4 mmHg in morning systolic pressure that occurred at 2 months in the continuous positive airway pressure arm as compared with an approximate 0.5 mmHg reduction in the sham group (continuous positive airway pressure effect -1.9 mmHg, p = .008). At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 mmHg, p = .12). Sensitivity analysis with use of multiple imputation approaches to account for missing data did not change the results. Treatment with continuous positive airway pressure for obstructive sleep apnea reduces morning but not evening blood pressure in a population with well-controlled blood pressure. The effect was greater after 2 than after 6 months of treatment.",2020,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","['1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study', 'obstructive sleep apnea patients', 'Participants with apnea-hypopnea index\u2005≥\xa010']","['continuous positive airway pressure or sham continuous positive airway pressure', 'continuous positive airway pressure', 'continuous positive airway pressure versus sham continuous positive airway pressure']","['Blood pressures', 'morning systolic pressure', 'blood pressure', 'Obstructive sleep apnea']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",1101.0,0.0328835,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Gottlieb', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Journal of sleep research,['10.1111/jsr.12943']
535,32160766,Neural Insensitivity to the Effects of Hunger in Women Remitted From Anorexia Nervosa.,"OBJECTIVE


Anorexia nervosa has the highest mortality rate of any psychiatric condition, yet the pathophysiology of this disorder and its primary symptom, extreme dietary restriction, remains poorly understood. In states of hunger relative to satiety, the rewarding value of food stimuli normally increases to promote eating, yet individuals with anorexia nervosa avoid food despite emaciation. This study's aim was to examine potential neural insensitivity to these effects of hunger in anorexia nervosa.
METHODS


At two scanning sessions scheduled 24 hours apart, one after a 16-hour fast and one after a standardized meal, 26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received tastes of sucrose solution or ionic water while functional MRI data were acquired. Within a network of interest responsible for food valuation and transforming taste signals into motivation to eat, the authors compared groups across conditions on blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity.
RESULTS


Participants in the two groups had similar BOLD responses to sucrose and water tastants. A group-by-condition interaction in the ventral caudal putamen indicated that hunger had opposite effects on tastant response in the control group and the remitted anorexia nervosa group, with an increase and a decrease, respectively, in BOLD response when hungry. Hunger had a similar opposite effect on insula-to-ventral caudal putamen functional connectivity in the remitted anorexia nervosa group compared with the control group. Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
CONCLUSIONS


Reduced recruitment of neural circuitry that translates taste stimulation to motivated eating behavior when hungry may facilitate food avoidance and prolonged periods of extremely restricted food intake in anorexia nervosa.",2020,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
","['26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received', 'anorexia nervosa', 'Anorexia nervosa', 'Women Remitted From Anorexia Nervosa']",['tastes of sucrose solution or ionic water while functional MRI data'],"['insula-to-ventral caudal putamen functional connectivity', 'BOLD responses to sucrose and water tastants', 'tastant response', 'blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity', 'BOLD response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",26.0,0.0655501,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
","[{'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Kaye', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Wierenga', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bischoff-Grethe', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Berner', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Alice V', 'Initials': 'AV', 'LastName': 'Ely', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Ursula F', 'Initials': 'UF', 'LastName': 'Bailer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Fudge', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19030261']
536,31869514,Insomnia does not affect heart rate changes when young adults watch humorous films: An exploratory study.,"Emotional reactivity in insomnia is affected both subjectively and on a physiological level for negative emotional material, but little is known about reactions to positive stimuli. We here investigated whether in younger adult insomnia patients, presentation of short humorous films would lead to heart rate decreases during and after film viewing, as compared to heart rate changes when falling asleep. Investigating 20 participants with DSM-5-diagnosed insomnia and 18 participants without insomnia, we found that heart rate decreased when falling asleep, increased when watching humorous films and returned to normal values afterwards for all participants. Film-related heart rate increases were strongly related to humour ratings of the films. No differences were found between those with and without insomnia on subjective ratings of the films, film-related heart rate changes or when falling asleep. We conclude that the experience of positive daily life stimuli in younger adults is not affected by insomnia in our study, despite insomnia having a known more profound effect on negative stimuli. Future studies exploring insomnia-related autonomous nervous system responses combining different neurophysiological modalities should confirm our findings.",2020,"No differences were found between those with and without insomnia on subjective ratings of the films, film-related heart rate changes or when falling asleep.","['younger adult insomnia patients', 'younger adults', '20 participants with DSM-5-diagnosed insomnia and 18 participants without insomnia']",[],"['heart rate changes', 'Emotional reactivity', 'subjective ratings of the films, film-related heart rate changes', 'heart rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",20.0,0.0405758,"No differences were found between those with and without insomnia on subjective ratings of the films, film-related heart rate changes or when falling asleep.","[{'ForeName': 'Ellemarije', 'Initials': 'E', 'LastName': 'Altena', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Célyne H', 'Initials': 'CH', 'LastName': 'Bastien', 'Affiliation': 'Ecole de Psychologie, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Ernesto J', 'Initials': 'EJ', 'LastName': 'Sanz-Arigita', 'Affiliation': 'UMR 5287-CNRS, INCIA - Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Daviaux', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Bioulac', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jean-Arthur', 'Initials': 'JA', 'LastName': 'Micoulaud-Franchi', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Taillard', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philip', 'Affiliation': 'USR 3413, Sommeil, Addiction et Neuropsychiatrie, Université de Bordeaux, Bordeaux, France.'}]",Journal of sleep research,['10.1111/jsr.12970']
537,31180173,Microsleep as a marker of sleepiness in obstructive sleep apnea patients.,"We hypothesized that: (a) the presence of microsleep (MS) during a Maintenance Wakefulness Test (MWT) trial may represent a reliable marker of sleepiness in obstructive sleep apnea (OSA) patients; (b) the number of MSs will be higher in sleepy versus non-sleepy patients with a borderline MWT mean sleep latency; and (c) scoring MS during MWT analysis may help physicians to recognize patients with a higher degree of sleepiness. We analysed the MWT data of 112 treatment-naïve OSA patients: 20 with short sleep latency (SL, sleep latency <12.8 min), 43 with borderline latency (BL, sleep latency between 12.8 and 32.6 min) and 49 with normal latency (NL, sleep latency >32.6 min). Microsleep was identified in all SL, in 42 BL and in 18 NL patients, with a median latency of 5.6 min. Accordingly, patients were classified into two subgroups: group A (n = 43) with microsleep latency <5.6 min and group B (n = 69) with microsleep latency >5.6 min when present. The mean sleep latency in the MWT was 14.5 ± 7.5 min in group A and 34.6 ± 7.4 min in group B (p < 0.0001). The number of microsleep episodes during each MWT trial was higher in group A than in group B. Sleep latency survival curves demonstrated different patterns of sleep latency in these groups (log-rank test <0.0001). This finding was confirmed in a Cox proportional hazard analysis: the presence of a mean MS latency <5.6 min is associated with an increasing risk of falling asleep during the MWT (RR, 1.93; 95 CI 1.04-3.6; p = 0.03). We conclude that the detection of microsleep may help in discriminating OSA patients with and without daytime vigilance impairment.",2020,The number of microsleep episodes during each MWT trial was higher in group A than in group B. Sleep latency survival curves demonstrated different patterns of sleep latency in these groups (log-rank test <0.0001).,"['discriminating OSA patients with and without daytime vigilance impairment', 'obstructive sleep apnea (OSA) patients', 'patients were classified into two subgroups: group A (n\xa0=\xa043) with microsleep latency <5.6\xa0min and group B (n\xa0=\xa069) with microsleep latency >5.6\xa0min when present', '112 treatment-naïve OSA patients: 20 with short sleep latency (SL, sleep latency <12.8\xa0min), 43 with borderline latency (BL, sleep latency between 12.8 and 32.6\xa0min) and 49 with normal latency (NL, sleep latency >32.6\xa0min', 'obstructive sleep apnea patients']",[],"['Sleep latency survival', 'mean sleep latency', 'number of microsleep episodes', 'sleep latency', 'risk of falling asleep']","[{'cui': 'C0205235', 'cui_str': 'Discriminate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4049266', 'cui_str': 'Microsleep'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]",[],"[{'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4049266', 'cui_str': 'Microsleep'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.0189184,The number of microsleep episodes during each MWT trial was higher in group A than in group B. Sleep latency survival curves demonstrated different patterns of sleep latency in these groups (log-rank test <0.0001).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Morrone', 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': ""D'Artavilla Lupo"", 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Trentin', 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Risi', 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Arcovio', 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfulla', 'Affiliation': 'Sleep and Respiratory Function Unit, Clinical and Scientific Institute of Pavia IRCCS, Pavia, Italy.'}]",Journal of sleep research,['10.1111/jsr.12882']
538,32160096,Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer.,"PURPOSE


Whether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer.
METHODS


This phase IIB trial randomly assigned patients to PBT or IMRT (50.4 Gy), stratified for histology, resectability, induction chemotherapy, and stage. The prespecified coprimary end points were TTB and PFS. TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs) in operated patients, quantified the extent of AE severity experienced over the duration of 1 year following treatment. The trial was conducted using Bayesian group sequential design with three planned interim analyses at 33%, 50%, and 67% of expected accrual (adjusted for follow-up).
RESULTS


This trial (commenced April 2012) was approved for closure and analysis upon activation of NRG-GI006 in March 2019, which occurred immediately prior to the planned 67% interim analysis. Altogether, 145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable. Median follow-up was 44.1 months. Fifty-one patients (30 IMRT, 21 PBT) underwent esophagectomy; 80% of PBT was passive scattering. The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0). The mean POC score was 7.6 times higher for IMRT (19.1; 7.3-32.3) versus PBT (2.5; 0.3-5.2). The posterior probability that mean TTB was lower for PBT compared with IMRT was 0.9989, which exceeded the trial's stopping boundary of 0.9942 at the 67% interim analysis. The 3-year PFS rate (50.8%  v  51.2%) and 3-year overall survival rates (44.5%  v  44.5%) were similar.
CONCLUSION


For locally advanced esophageal cancer, PBT reduced the risk and severity of AEs compared with IMRT while maintaining similar PFS.",2020,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","['145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable', 'Locally Advanced Esophageal Cancer']","['esophagectomy', 'PBT or IMRT', 'Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy', 'PBT', 'IMRT', 'proton beam therapy (PBT', 'intensity-modulated radiation therapy (IMRT']","['posterior mean TTB', 'TTB and PFS', 'total toxicity burden (TTB) and progression-free survival (PFS', '3-year PFS rate', '3-year overall survival rates', 'posterior probability that mean TTB', 'mean POC score', 'TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",145.0,0.283472,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","[{'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Quantitative Health Sciences, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Tidwell', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiudong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Corsini', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mok', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ritsuko U', 'Initials': 'RU', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Melenda D', 'Initials': 'MD', 'LastName': 'Jeter', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jaffer A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ara A', 'Initials': 'AA', 'LastName': 'Vaporciyan', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Reza J', 'Initials': 'RJ', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Koong', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Gandhi', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Hofstetter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Delaney', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02503']
539,32094219,Brief interventions for obesity when patients are asked to pay for weight loss treatment: an observational study in primary care with an embedded randomised trial.,"BACKGROUND


A brief intervention whereby GPs opportunistically facilitate an NHS-funded referral to a weight loss programme is clinically and cost-effective.
AIM


To test the acceptability of a brief intervention and attendance at a weight loss programme when GPs facilitate a referral that requires patients to pay for the service.
DESIGN AND SETTING


An observational study of the effect of a GP encouraging attendance at a weight loss programme requiring self-payment in the West Midlands from 16 October 2018 to 30 November 2018, to compare with a previous trial in England in which the service was NHS-funded.
METHOD


Sixty patients with obesity who consecutively attended primary care appointments received an opportunistic brief intervention by a GP to endorse and offer a referral to a weight loss programme at the patient's own expense. Participants were randomised to GPs who either stated the weekly monetary cost of the programme (basic cost) or who compared the weekly cost to an everyday discretionary item (cost comparison). Participants were subsequently asked to report whether they had attended a weight loss programme.
RESULTS


Overall, 47% of participants ( n  = 28) accepted the referral; 50% ( n  = 15) in the basic cost group and 43% ( n  = 13) in the cost comparison group. This was significantly less than in a previous study when the programme was NHS-funded (77%,  n  = 722/940;  P <0.0001). Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004). One person (2%) attended the weight loss programme, which is significantly lower than the 40% of participants who attended when the programme was NHS-funded ( P <0.0001).
CONCLUSION


GP referral to a weight loss programme that requires patients to pay rather than offering an NHS-funded programme is acceptable; however, it results in almost no attendance.",2020,"Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004).","['encouraging attendance at a weight loss programme requiring self-payment in the West Midlands from 16 October 2018 to 30 November 2018, to compare with a previous trial in England in which the service was NHS-funded', 'Sixty patients with obesity who consecutively attended primary care appointments received an', 'Participants were subsequently asked to report whether they had attended a weight loss programme']","['opportunistic brief intervention by a GP to endorse and offer a referral to a weight loss programme', 'GP', 'GPs who either stated the weekly monetary cost of the programme (basic cost) or who compared the weekly cost to an everyday discretionary item (cost comparison']",['weight loss programme'],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1278502', 'cui_str': 'Appointment received'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",60.0,0.0622502,"Most participants reported the intervention to be helpful/very helpful and appropriate/very appropriate (78%,  n  = 46/59 and 85%,  n  = 50/59, respectively) but scores were significantly lower than when the programme was NHS-funded (92%  n  = 851/922 and 88%  n  = 813/922, respectively;  P  = 0.004).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tudor', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Manoharan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford; National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X708797']
540,32071281,Treat-to-target in PsA: methods and necessity.,"With increasing recognition of the high burden and impact of psoriatic arthritis (PsA) and the growing number of therapeutic options, there has been an intensifying focus on treatment strategy in recent years. In 2015, the Tight Control of Psoriatic Arthritis study confirmed the clinical benefit of using a treat-to-target approach in PsA. This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events. European and international recommendations support the use of a treat-to-target approach in PsA and have offered specific advice on how to do this using outcomes such as the minimal disease activity criteria. However, implementation of this approach in routine practice is low, with real-world data highlighting undertreatment as a result. Recent qualitative work with physicians in the UK has helped researchers to understand the barriers to implementation of treat-to-target in PsA. We now need to address these barriers, provide education and support to non-specialist clinicians in routine practice, and aid the translation of optimal care to the clinic.",2020,"This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events.",[],[],[],[],[],[],,0.0579559,"This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dures', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Shepperd', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Rheumatology, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Health and Applied Sciences, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, Coventry, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Centre for Health and Clinical Research, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK laura.coates@ndorms.ox.ac.uk.'}]",RMD open,['10.1136/rmdopen-2019-001083']
541,31663925,A Novel Patient-Specific Model for Predicting Severe Oliguria; Development and Comparison With Kidney Disease: Improving Global Outcomes Acute Kidney Injury Classification.,"OBJECTIVES


The Kidney Disease: Improving Global Outcomes urine output criteria for acute kidney injury lack specificity for identifying patients at risk of adverse renal outcomes. The objective was to develop a model that analyses hourly urine output values in real time to identify those at risk of developing severe oliguria.
DESIGN


This was a retrospective cohort study utilizing prospectively collected data.
SETTING


A cardiac ICU in the United Kingdom.
PATIENTS


Patients undergoing cardiac surgery between January 2013 and November 2017.
INTERVENTIONS


None.
MEASUREMENT AND MAIN RESULTS


Patients were randomly assigned to development (n = 981) and validation (n = 2,389) datasets. A patient-specific, dynamic Bayesian model was developed to predict future urine output on an hourly basis. Model discrimination and calibration for predicting severe oliguria (< 0.3 mL/kg/hr for 6 hr) occurring within the next 12 hours were tested in the validation dataset at multiple time points. Patients with a high risk of severe oliguria (p > 0.8) were identified and their outcomes were compared with those for low-risk patients and for patients who met the Kidney Disease: Improving Global Outcomes urine output criterion for acute kidney injury. Model discrimination was excellent at all time points (area under the curve > 0.9 for all). Calibration of the model's predictions was also excellent. After adjustment using multivariable logistic regression, patients in the high-risk group were more likely to require renal replacement therapy (odds ratio, 10.4; 95% CI, 5.9-18.1), suffer prolonged hospital stay (odds ratio, 4.4; 95% CI, 3.0-6.4), and die in hospital (odds ratio, 6.4; 95% CI, 2.8-14.0) (p < 0.001 for all). Outcomes for those identified as high risk by the model were significantly worse than for patients who met the Kidney Disease: Improving Global Outcomes urine output criterion.
CONCLUSIONS


This novel, patient-specific model identifies patients at increased risk of severe oliguria. Classification according to model predictions outperformed the Kidney Disease: Improving Global Outcomes urine output criterion. As the new model identifies patients at risk before severe oliguria develops it could potentially facilitate intervention to improve patient outcomes.",2020,Classification according to model predictions outperformed the Kidney Disease:,"['Kidney Disease', 'A cardiac ICU in the United Kingdom', 'Patients with a high risk of severe oliguria (p > 0.8', 'Patients undergoing cardiac surgery between January 2013 and November 2017']",[],"['suffer prolonged hospital stay', 'severe oliguria', 'die in hospital', 'renal replacement therapy']","[{'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028961', 'cui_str': 'Oligurias'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028961', 'cui_str': 'Oligurias'}, {'cui': 'C0420302', 'cui_str': 'Died in hospital (finding)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",,0.0530416,Classification according to model predictions outperformed the Kidney Disease:,"[{'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Howitt', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oakley', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Caiado', 'Affiliation': 'Department of Mathematical Sciences, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Mathematical Sciences, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Malagon', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCollum', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Stuart W', 'Initials': 'SW', 'LastName': 'Grant', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, ERC, Manchester University Hospitals Foundation Trust, Manchester, United Kingdom.'}]",Critical care medicine,['10.1097/CCM.0000000000004074']
542,31225667,A web-based tailored nursing intervention (TAVIE en m@rche) aimed at increasing walking after an acute coronary syndrome: Multicentre randomized trial.,"AIM


Evaluate a web-based tailored nursing intervention, TAVIE en m@rche, on increasing daily steps after an acute coronary syndrome.
DESIGN


Parallel two-group multicentre randomized trial.
METHODS


An experimental group receiving TAVIE en m@rche, was compared to  a control group receiving hyperlinks to public websites. Acute coronary syndrome patients who were insufficiently active were recruited from three coronary care units. Daily steps at 12 weeks were the primary outcome. Secondary outcomes included self-reported walking and moderate to vigorous physical activity (MVPA). Exploratory outcomes were angina frequency, emergency department visits, hospitalizations and secondary prevention programme attendance.
RESULTS


Primary data were analysed for 39 participants. No significant effects were found. At 12 weeks 275.9 more daily steps and 1,464.3 more energy expenditure in MVPA were found in the experimental group relative to the control. No effects were found for angina frequency, emergency department visits, hospitalizations and secondary prevention programme attendance.
CONCLUSION


The lack of effect on our primary result may be explained by the intervention goal that was mismatched to the needs of our mostly sufficiently active sample at randomization, resulting in no meaningful change in daily steps. Although the non-significantly greater increase in self-reported MVPA may represent gains in health among the participants that accessed TAVIE en m@rche, this result should be interpreted with caution.
IMPACT


From 40%-60% of acute coronary syndrome patients self-report insufficient levels of physical activity. No effect was found on the primary outcome of daily steps. Although not significant, a greater increase in MVPA was found at 12 weeks. The primary outcome can be explained by most of the sample having attained the physical activity recommendation at randomization. Caution in interpreting the non-significant increase in MVPA is warranted due to attrition bias and statistical uncertainty. Future directions may consider the timing of randomization in relation to meeting the needs of insufficiently active acute coronary syndrome patients.",2019,"No effects were found for angina frequency, emergency department visits, hospitalizations and secondary prevention program attendance.
","['active Acute coronary syndrome patients', 'Acute coronary syndrome patients who were insufficiently active were recruited from three coronary care units', 'acute coronary syndrome']","['TAVIE', 'control group receiving hyperlinks to public websites', 'web-based tailored nursing intervention, TAVIE en']","['energy expenditure in moderate to vigorous physical activity', 'angina frequency, emergency department visits, hospitalizations and secondary prevention program attendance', 'self-reported walking and moderate to vigorous physical activity', 'moderate to vigorous physical activity']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0817032,"No effects were found for angina frequency, emergency department visits, hospitalizations and secondary prevention program attendance.
","[{'ForeName': 'John William', 'Initials': 'JW', 'LastName': 'Kayser', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cossette', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute Research Center, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tremblay', 'Affiliation': ""Integrated Health and Social Services Centres, l'Est de l'Île de Montréal, Montréal, Quebec, Canada.""}, {'ForeName': 'Jean Gino', 'Initials': 'JG', 'LastName': 'Diodati', 'Affiliation': 'Hôpital du Sacré-Cœur de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bourbonnais', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Purden', 'Affiliation': 'Ingram School of Nursing, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Montreal Heart Institute Research Center, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Terrier', 'Affiliation': 'Montreal Heart Institute Research Center, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Dupuis', 'Affiliation': 'Montreal Heart Institute Research Center, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Maheu-Cadotte', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Fontaine', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cournoyer', 'Affiliation': 'Montreal Health Innovations Coordinating Center, Montréal, Quebec, Canada.'}]",Journal of advanced nursing,['10.1111/jan.14119']
543,32106777,Efficacy and safety of revefenacin for nebulization in patients with chronic obstructive pulmonary disease taking concomitant ICS/LABA or LABA: subgroup analysis from phase III trials.,"BACKGROUND


Combinations of a long-acting muscarinic receptor antagonist (LAMA), long-acting β-agonist (LABA), and inhaled corticosteroid (ICS) are used for patients with persistent chronic obstructive pulmonary disease (COPD) exacerbations on bronchodilator monotherapy. In this prespecified subgroup analysis, we assessed the efficacy and safety of the LAMA revefenacin in patients with COPD taking concomitant LABA, including ICS/LABA (LABA subgroup).
METHODS


Efficacy data were obtained from two 12-week, replicate, placebo-controlled trials and safety data were pooled from the 12-week and a 52-week tiotropium-controlled trial. Patients received revefenacin 175 µg or placebo in the 12-week or tiotropium 18 µg in the 52-week studies. The efficacy endpoint was least squares (LS) mean change from baseline in trough forced expiratory volume in 1 second (FEV 1 ). Clinical health outcomes were assessed using the St. George's Respiratory Questionnaire (SGRQ).
RESULTS


Revefenacin produced similar improvements from baseline in trough FEV 1  in the non-LABA and LABA subgroups [placebo-adjusted LS mean change (95% confidence interval) in day 85 trough FEV 1 , 150.9 (110.3-191.6) ml and 139.2 (82.9-195.5) ml;  p  < 0.0001  versus  placebo]. Similar improvements were observed in SGRQ scores in the non-LABA and LABA subgroups [-3.3 (-5.4 to -1.2) and -3.4 (-6.3 to -0.6)]. Improvements in lung function and health outcomes were observed regardless of airflow obstruction severity. Revefenacin was well tolerated with more adverse events reported in the LABA than the non-LABA subgroup.
CONCLUSIONS


Once daily revefenacin for nebulization can be an effective and well-tolerated treatment for patients who require concomitant use of LABA with or without ICS.
CLINICALTRIALS.GOV IDENTIFIERS


NCT02512510, NCT02459080, NCT02518139  The reviews of this paper are available via the supplemental material section.",2020,"RESULTS


Revefenacin produced similar improvements from baseline in trough FEV 1  in the non-LABA and LABA subgroups [placebo-adjusted LS mean change (95% confidence interval) in day 85 trough","['patients with chronic obstructive pulmonary disease taking concomitant ICS/LABA or LABA: subgroup analysis from phase III trials', 'patients who require concomitant use of LABA with or without ICS', 'patients with COPD taking concomitant LABA, including ICS/LABA (LABA subgroup', 'patients with persistent chronic obstructive pulmonary disease (COPD) exacerbations on bronchodilator monotherapy']","['revefenacin', 'revefenacin 175\u2009µg or placebo', 'placebo', 'muscarinic receptor antagonist (LAMA), long-acting β-agonist (LABA), and inhaled corticosteroid (ICS', 'LAMA revefenacin', 'tiotropium', 'Revefenacin']","['efficacy and safety', 'Efficacy and safety', 'trough FEV', ""St. George's Respiratory Questionnaire (SGRQ"", 'lung function and health outcomes', 'Clinical health outcomes', 'SGRQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}]","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.466766,"RESULTS


Revefenacin produced similar improvements from baseline in trough FEV 1  in the non-LABA and LABA subgroups [placebo-adjusted LS mean change (95% confidence interval) in day 85 trough","[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'University at Buffalo, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Donohue', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA 94080, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620905278']
544,30679318,Everolimus plus Exemestane for Hormone Receptor-Positive Advanced Breast Cancer: A PAM50 Intrinsic Subtype Analysis of BOLERO-2.,"BACKGROUND


The prognostic and predictive value of the two nonluminal (human epidermal growth factor receptor 2 [HER2]-enriched and basal-like) subtypes within advanced hormone receptor-positive (HR+) breast cancer is currently unknown.
MATERIALS AND METHODS


This study retrospectively analyzed 261 tumors (80.7% primary; 19.3% metastatic) from the BOLERO-2 study; BOLERO-2 randomized 724 patients with advanced HR+/HER2-negative breast cancer to everolimus plus exemestane or placebo plus exemestane. Tumors were classified using a PAM50 subtype predictor. Multivariable Cox regression analyses tested the independent prognostic significance of PAM50, and associations between PAM50 subtypes and treatment upon progression-free survival (PFS) were evaluated.
RESULTS


Subtype distribution was 46.7% luminal A ( n  = 122), 21.5% HER2-enriched ( n  = 56), 15.7% luminal B ( n  = 41), 14.2% normal-like ( n  = 37), and 1.9% basal-like ( n  = 5); HER2-enriched subtypes were more common in metastatic versus primary tumors (32.0% vs. 18.7%;  p  = .038). Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant. Everolimus plus exemestane significantly improved median PFS versus placebo plus exemestane among patients with HER2-enriched tumors (5.8 vs. 4.1 months; adjusted hazard ratio, 0.49; 95% CI, 0.26-0.90;  p  = .034); however, the association between HER2-enriched tumors and everolimus benefit was nonsignificant ( p  = .433).
CONCLUSION


The HER2-enriched subtype was identified in a substantial proportion of advanced HR+/HER2-negative breast tumors, and was a consistent biomarker of poor prognosis. Tailored therapies are therefore needed for HER2-enriched tumors in the advanced HR+/HER2-negative breast cancer setting.
IMPLICATIONS FOR PRACTICE


Using 261 tumor samples from the BOLERO-2 phase III clinical trial, this study shows that a substantial proportion (20%-30%) of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancers do not have a luminal A or B gene expression profile. This group of patients with nonluminal disease has a poor survival outcome regardless of the addition of everolimus to exemestane. This is the second study that confirms the prognostic value of this biomarker. Overall, these findings indicate a necessity to design novel clinical trials targeting nonluminal disease within HR+/HER2-negative breast cancer.",2019,"Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant.","['261 tumors (80.7% primary; 19.3% metastatic) from the BOLERO-2 study; BOLERO-2 randomized 724 patients with advanced HR+/HER2-negative breast cancer to', 'patients with HER2-enriched tumors', 'Hormone Receptor-Positive Advanced Breast Cancer']","['placebo plus exemestane', 'everolimus plus exemestane or placebo plus exemestane', 'Everolimus plus exemestane', 'Everolimus plus Exemestane', 'exemestane']","['Median PFS differences', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0244436', 'cui_str': 'Bolero'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",724.0,0.154725,"Median PFS differences between luminal and nonluminal (6.7 vs. 5.2 months; adjusted hazard ratio, 0.66; 95% confidence interval [CI], 0.47-0.94;  p  = .020) and HER2-enriched and non-HER2-enriched subtypes (5.2 vs. 6.2 months; adjusted hazard ratio, 1.53; 95% CI, 1.07-2.19;  p  = .019) were significant.","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain alprat@clinic.ub.es.'}, {'ForeName': 'Jan Christoph', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'University Hospital 12 de Octubre, Madrid, Spain.'}]",The oncologist,['10.1634/theoncologist.2018-0407']
545,31633865,The effect of acute exposure to morphine on breathing variability and cardiopulmonary coupling in men with obstructive sleep apnea: A randomized controlled trial.,"Opioid-related deaths from respiratory depression are increasing but there is only limited information on the effect of morphine on breathing during sleep. This study aimed to detect and quantify opioid-induced cardiorespiratory pattern changes during sleep in obstructive sleep apnea (OSA) patients using novel automated methods and correlate these with conventional polysomnography (PSG) measures. Under a randomized double-blind placebo-controlled crossover design, 60 male OSA patients attended two one-night visits to the sleep laboratory, at least a week apart. Either a 40-mg controlled-release oral morphine dose or placebo was administered. Breathing during sleep was measured by standard in-laboratory PSG. We analysed the inter-breath interval (IBI) from the PSG flow channel to quantify breathing irregularity. Cardiopulmonary coupling (CPC) was analysed using the PSG electrocardiogram (ECG) channel. Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night. A higher CPC sleep quality index was found with morphine use. The change of key IBI and CPC parameters was significantly correlated with the change of key PSG sleep-disordered breathing parameters. In conclusion, 40 mg controlled-release morphine resulted in a longer breathing cycle and increased breathing irregularity but generally more stable sleep in OSA patients. The significant links between the IBI and CPC techniques and a range of PSG sleep-disordered breathing parameters may suggest a practical value as surrogate overnight cardiorespiratory measurements, because both respiratory flow and ECG can be detected by small portable devices.",2020,"Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night.","['obstructive sleep apnea (OSA) patients', '60 male OSA patients attended two one-night visits to the sleep laboratory, at least a week apart', 'men with obstructive sleep apnea']","['morphine', 'Cardiopulmonary coupling (CPC', 'placebo', 'conventional polysomnography (PSG', 'morphine dose or placebo']","['change of key IBI and CPC parameters', 'longer breathing cycle and increased breathing irregularity', 'irregular breathing with increased IBI coefficient of variation (CV', 'Breathing during sleep', 'longer inter-breath interval', 'inter-breath interval (IBI', 'breathing variability and cardiopulmonary coupling', 'CPC sleep quality index']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0425492', 'cui_str': 'Irregular breathing (finding)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0561392,"Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night.","[{'ForeName': 'Justin G-A', 'Initials': 'JG', 'LastName': 'Wu', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Rowsell', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Chinh D', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': ""Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hugi', 'Initials': 'H', 'LastName': 'Hilmisson', 'Affiliation': 'MyCardio-LLC, SleepImage®, Denver, CO, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Thomas', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}]",Journal of sleep research,['10.1111/jsr.12930']
546,31958280,Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial.,"OBJECTIVES


Anti-drug antibodies (ADA) are responsible for decreased adalimumab efficacy in axial spondyloarthritis (SpA). We aimed to evaluate the ability of methotrexate (MTX) to decrease adalimumab immunisation.
METHODS


A total of 110 patients eligible to receive adalimumab 40 mg subcutaneously (s.c.) every other week were randomised (1:1 ratio) to receive, 2 weeks before adalimumab (W-2) and weekly, MTX 10 mg s.c. (MTX+) or not (MTX-). ADA detection and adalimumab serum concentration were assessed at weeks 4 (W4), 8 (W8), 12 (W12) and 26 (W26) after starting adalimumab (W0). The primary outcome was the proportion of patients with ADA at W26. Four years after the study completion, we retrospectively analysed adalimumab maintenance in relation with MTX co-treatment duration.
RESULTS


We analysed data for 107 patients (MTX+; n=52; MTX-; n=55). ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX- group (p=0.03). Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26. The two groups did not differ in adverse events or efficacy. In the follow-up study, MTX co-treatment >W26 versus no MTX or ≤W26 was significantly associated with adalimumab long-term maintenance (p=0.04).
CONCLUSION


MTX reduces the immunogenicity and ameliorate the pharmacokinetics of adalimumab in axial SpA. A prolonged co-treatment of MTX>W26 seems to increase adalimumab long-term maintenance.",2020,"Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26.","['axial spondyloarthritis', 'axial SpA', '110 patients eligible to receive', '107 patients (MTX+; n=52; MTX-; n=55']","['adalimumab 40\u2009mg subcutaneously (s.c', 'adalimumab (W-2) and weekly, MTX', 'Methotrexate', 'adalimumab', 'methotrexate (MTX', 'MTX', 'MTX co-treatment duration', 'MTX+) or not (MTX']","['adverse events or efficacy', 'ADA detection and adalimumab serum concentration', 'proportion of patients with ADA', 'Adalimumab concentration', 'ADA']","[{'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",110.0,0.111152,"Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26.","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Ducourau', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Rispens', 'Affiliation': 'Landsteiner Laboratory, Sanquin Research, Amsterdam, Netherlands.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Samain', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Department of Rheumatology, CH du Mans, Le Mans, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Le Guilchard', 'Affiliation': 'Department of Rheumatology, CH de Blois, Blois, France.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Andras', 'Affiliation': 'Department of Rheumatology, CH de Blois, Blois, France.'}, {'ForeName': 'Aleth', 'Initials': 'A', 'LastName': 'Perdriger', 'Affiliation': 'Department of Rheumatology, CHRU de Rennes, Rennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': ""Department of Rheumatology, CHR d'Orléans, Orléans, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Department of Rheumatology, CH de Saint-Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Cormier', 'Affiliation': 'Department of Rheumatology, CHD Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Armingeat', 'Affiliation': 'Department of Rheumatology, CH de Saint-Nazaire, Saint-Nazaire, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Devauchelle-Pensec', 'Affiliation': 'Department of Rheumatology, Université de Brest, Inserm UMR1227 LBAI, CHRU de Brest, Brest, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gervais', 'Affiliation': 'Department of Rheumatology, CHRU de Poitiers, Poitiers, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Le Goff', 'Affiliation': 'Department of Rheumatology, CHRU de Nantes, Nantes, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'de Vries', 'Affiliation': 'Biologicals Lab, Sanquin Diagnostic Services, Amsterdam, Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Piver', 'Affiliation': 'Department of Biochemistry, University of Tours, Inserm U 1259, CHRU de Tours, Tours, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Paintaud', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Desvignes', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ternant', 'Affiliation': 'Department of Pharmacology-Toxicology, University of Tours, EA GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Watier', 'Affiliation': 'Department of Immunology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mulleman', 'Affiliation': 'Department of Rheumatology, University of Tours, EA 7501 GICC, CHRU de Tours, Tours, France denis.mulleman@univ-tours.fr.'}]",RMD open,['10.1136/rmdopen-2019-001047']
547,30508316,One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study.,"Romosozumab, a humanized monoclonal antibody that binds and inhibits sclerostin, has the dual effect of increasing bone formation and decreasing bone resorption. As previously reported in the pivotal FRActure study in postmenopausal woMen with ostEoporosis (FRAME), women with a T-score of ≤ -2.5 at the total hip or femoral neck received subcutaneous placebo or romosozumab once monthly for 12 months, followed by open-label subcutaneous denosumab every 6 months for an additional 12 months. Upon completion of the 24-month primary analysis period, eligible women entered the extension phase and received denosumab for an additional 12 months. Here, we report the final analysis results through 36 months, including efficacy assessments of new vertebral, clinical, and nonvertebral fracture; bone mineral density (BMD); and safety assessments. Of 7180 women enrolled, 5743 (80%) completed the 36-month study (2851 romosozumab-to-denosumab; 2892 placebo-to-denosumab). Through 36 months, fracture risk was reduced in subjects receiving romosozumab versus placebo for 12 months followed by 24 months of denosumab for both groups: new vertebral fracture (relative risk reduction [RRR], 66%; incidence, 1.0% versus 2.8%; p < 0.001), clinical fracture (RRR, 27%; incidence, 4.0% versus 5.5%; p = 0.004), and nonvertebral fracture (RRR, 21%; incidence, 3.9% versus 4.9%; p = 0.039). BMD continued to increase for the 2 years with denosumab treatment in both arms. The substantial difference in BMD achieved through 12 months of romosozumab treatment versus placebo was maintained through the follow-up period when both treatment arms received denosumab. Subject incidence of adverse events, including positively adjudicated serious cardiovascular adverse events, were overall balanced between groups. In conclusion, in postmenopausal women with osteoporosis, 12 months of romosozumab led to persistent fracture reduction benefit and ongoing BMD gains when followed by 24 months of denosumab. The sequence of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis. © 2018 American Society for Bone and Mineral Research.",2019,"Through 36 months, fracture risk was reduced in subjects receiving romosozumab versus placebo for 12 months followed by 24 months of denosumab for both groups: new vertebral fracture (relative risk reduction [RRR], 66%; incidence, 1.0% versus 2.8%; p < 0.001), clinical fracture (RRR, 27%; incidence, 4.0% versus 5.5%; p = 0.004), and nonvertebral fracture (RRR, 21%; incidence, 3.9% versus 4.9%; p = 0.039).","['© 2018 American Society for Bone and Mineral Research', '7180 women enrolled, 5743 (80%) completed the 36-month study (2851', 'postmenopausal woMen with ostEoporosis (FRAME), women with a T-score of ≤ -2.5 at the total hip or femoral neck received', 'postmenopausal women with osteoporosis']","['placebo', 'romosozumab', 'Denosumab Maintains', 'subcutaneous placebo or romosozumab', 'romosozumab-to-denosumab; 2892 placebo-to-denosumab', 'Romosozumab', 'denosumab', 'romosozumab versus placebo']","['persistent fracture reduction benefit and ongoing BMD gains', 'BMD', 'Fracture Risk Reductions', 'nonvertebral fracture', 'fracture risk', 'clinical fracture', 'efficacy assessments of new vertebral, clinical, and nonvertebral fracture; bone mineral density (BMD); and safety assessments']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",7180.0,0.0593219,"Through 36 months, fracture risk was reduced in subjects receiving romosozumab versus placebo for 12 months followed by 24 months of denosumab for both groups: new vertebral fracture (relative risk reduction [RRR], 66%; incidence, 1.0% versus 2.8%; p < 0.001), clinical fracture (RRR, 27%; incidence, 4.0% versus 5.5%; p = 0.004), and nonvertebral fracture (RRR, 21%; incidence, 3.9% versus 4.9%; p = 0.039).","[{'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.'}, {'ForeName': 'Rajani V', 'Initials': 'RV', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Marise', 'Initials': 'M', 'LastName': 'Lazaretti-Castro', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Gielen', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Cassandra E', 'Initials': 'CE', 'LastName': 'Milmont', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3622']
548,31278091,Protocol for the evaluation of a pilot implementation of essential interventions for the prevention of cardiovascular diseases in primary healthcare in the Republic of Moldova.,"INTRODUCTION


Nearly 90% of all deaths in the Republic of Moldova are caused by non-communicable diseases, the majority of which (55%) are caused by cardiovascular diseases (CVD). In addition to reducing premature mortality from CVD, it is estimated that strengthening primary healthcare could cut the number of hypertension-related hospital admissions and diabetes-related hospitalisations in half. The aim of this evaluation is to determine the feasibility of implementing and evaluating essential interventions for the prevention of CVD in primary healthcare in the Republic of Moldova, with a view towards national scale-up.
METHODS AND ANALYSIS


A national steering group including international experts will be convened to adapt WHO Package of Essential NCD Intervention from Primary Healthcare in Low Resource Settings protocols 1 and 2 to the health system of the Republic of Moldova, develop and conduct training of primary healthcare workers and test a core set of indicators to monitor the quality of care and change in clinical practice. To evaluate the impact of this pilot implementation, a pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands of equal weight, will be used. Twenty primary healthcare centres will be selected and randomised to the training and implementation arm (n=10) and the usual care arm (n=10). At baseline and 12 months follow-up, a standardised data collection form will be piloted to extract data directly from patient paper records in order to estimate the change in clinical practice. Semi-structured interviews and interclinic peer workshops will be conducted at 12 months follow-up, and qualitative data collected from these formats will be analysed thematically for explanatory themes that relate to the quantitative findings.
ETHICS AND DISSEMINATION


Ethical review and approval has been obtained. Findings of the evaluation will be shared in a project report to key stakeholders, presented back to participants and written into a manuscript for an open access peer-reviewed scientific journal.",2019,"Nearly 90% of all deaths in the Republic of Moldova are caused by non-communicable diseases, the majority of which (55%) are caused by cardiovascular diseases (CVD).","['primary healthcare in the Republic of Moldova', 'Twenty primary healthcare centres']",[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0026374', 'cui_str': 'Moldavian S.S.R.'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],[],20.0,0.0653431,"Nearly 90% of all deaths in the Republic of Moldova are caused by non-communicable diseases, the majority of which (55%) are caused by cardiovascular diseases (CVD).","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'World Health Organization, Chisinau, The Republic of Moldova.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Epidemiology and Health Promotion, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Ghenadie', 'Initials': 'G', 'LastName': 'Curocichin', 'Affiliation': 'World Health Organization, Chisinau, The Republic of Moldova.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Salaru', 'Affiliation': 'World Health Organization, Chisinau, The Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zatic', 'Affiliation': 'World Health Organization, Chisinau, The Republic of Moldova.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Anisei', 'Affiliation': 'World Health Organization, Chisinau, The Republic of Moldova.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2018-025705']
549,31286656,Feasibility and effectiveness of two built environmental interventions on physical activity among 3-5-year-old preschoolers.,"PURPOSE


The purpose was to examine the feasibility and preliminary effectiveness of two built environmental interventions with Head Start preschool children to increase minutes and intensity and total physical activity (PA).
DESIGN AND METHODS


A prospective, quasi-experimental, repeated measures design was conducted in two Head Start centers. Centers were randomly assigned to one of two intervention arms. Intervention Arm I added portable play equipment to the school environment; Arm II introduced portable play equipment plus PA education for staff and children. PA was measured during school using accelerometers and by observation using SOPLAY. The data were analyzed using repeated measures ANOVA.
RESULTS


Ninety-seven children and eight staff were enrolled; valid PA data were available for 56 children (58%). Minutes of PA were highest at baseline in both groups and declined over the intervention. PA in Arm I decreased 22 min from weeks one to three and 12 min (p < .001) from weeks 3 to 6. In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6.
PRACTICE IMPLICATIONS


Nurses work to maintain and improve health at multiple levels of influence and are in strategic positions to educate and support PA to maintain and improve the health of all ages. School-based PA interventions have been reported with varying success. The feasibility of this study provides insight into the challenges in planning and conducting school-based interventions including enrollment, attrition, and accelerometer wear-time compliance. Despite our interventions, there was no positive response to either intervention, with PA declining at each time period in both groups. However, baseline PA was significantly higher than in previous studies. Schools can provide children with opportunities to accumulate PA.",2019,"In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6.
","['3-5-year-old\xa0preschoolers', 'Head Start preschool children', 'Ninety-seven children and eight staff']","['built environmental interventions', 'School-based PA interventions']","['physical activity', 'baseline PA', 'PA', 'intensity and total physical activity (PA']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C0026118', 'cui_str': 'Situational Therapy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",97.0,0.0223241,"In Arm II, PA declined 33 min from weeks one to three and 20 min (p < .001) from weeks 3 to 6.
","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Robinson', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Temple', 'Affiliation': 'Division of Associate Degree Nursing, Southwest Mississippi Community College, Summit, Mississippi.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Duck', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Klamm', 'Affiliation': 'School of Nursing, University of Mississippi Medical Center, Jackson, Mississippi.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12262']
550,31278095,Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial.,"INTRODUCTION


Active surveillance (AS) is the preferred primary treatment strategy for men with low-risk clinically localised prostate cancer (PCa); however, the majority of these men still receive radical treatment within 10 years due to disease progression and/or fear of cancer progression. Interventions designed to suppress tumour growth, mitigate fear of cancer progression and precondition men for impending radical treatments are an unmet clinical need. Exercise has been shown to delay the progression of prostate tumours in animal models, improve physical and functional health and manage psychological outcomes in cancer patients; however, these outcomes have not been demonstrated in PCa patients undergoing AS.
METHODS AND ANALYSIS


This phase II randomised controlled trial will randomise 66 men undergoing AS to either an exercise group or a usual care group. The exercise group will perform a 12-week, supervised, high-intensity interval training programme, consisting of 3 sessions/week for 28-40 min/session. The primary outcome will be cardiorespiratory fitness. Secondary outcomes will include immunosurveillance and cancer-related biomarkers, psychosocial outcomes including fear of cancer progression and quality of life and physical function. Exploratory outcomes will include clinical indicators of disease progression. The trial has 80% power to detect a significant between-group difference in VO 2peak  of 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.
ETHICS AND DISSEMINATION


The study has received full ethical approval from the Health Research Ethics Board of Alberta - Cancer Committee (Protocol Number: HREBA.CC-17-0248). The findings of the study will be disseminated through public and scientific channels.
TRIAL REGISTRATION NUMBER


NCT03203460; Pre-results.",2019,"The trial has 80% power to detect a significant between-group difference in VO 2peak  of 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.
","['66 men undergoing AS to either an exercise group or a usual care group', 'cancer patients', 'PCa patients undergoing AS', 'men with low-risk clinically localised prostate cancer (PCa']",['Exercise'],"['cardiorespiratory fitness', 'immunosurveillance and cancer-related biomarkers, psychosocial outcomes including fear of cancer progression and quality of life and physical function', 'VO 2peak']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026428', 'cui_str': 'Monitoring, Immunological'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",66.0,0.0981315,"The trial has 80% power to detect a significant between-group difference in VO 2peak  of 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.
","[{'ForeName': 'Dong-Woo', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian S', 'Initials': 'AS', 'LastName': 'Fairey', 'Affiliation': 'Division of Urology, Department of Surgery, Facultyof Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'Boulé', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Field', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-026438']
551,31278097,Protocol of a randomised controlled trial in cardiac surgical patients with endothelial dysfunction aimed to prevent postoperative acute kidney injury by administering nitric oxide gas.,"INTRODUCTION


Postoperative acute kidney injury (AKI) is a common complication in cardiac surgery. Levels of intravascular haemolysis are strongly associated with postoperative AKI and with prolonged (>90 min) use of cardiopulmonary bypass (CPB). Ferrous plasma haemoglobin released into the circulation acts as a scavenger of nitric oxide (NO) produced by endothelial cells. Consequently, the vascular bioavailability of NO is reduced, leading to vasoconstriction and impaired renal function. In patients with cardiovascular risk factors, the endothelium is dysfunctional and cannot replenish the NO deficit. A previous clinical study in young cardiac surgical patients with rheumatic fever, without evidence of endothelial dysfunction, showed that supplementation of NO gas decreases AKI by converting ferrous plasma haemoglobin to ferric methaemoglobin, thus preserving vascular NO. In this current trial, we hypothesised that 24 hours administration of NO gas will reduce AKI following CPB in patients with endothelial dysfunction.
METHODS


This is a single-centre, randomised (1:1) controlled, parallel-arm superiority trial that includes patients with endothelial dysfunction, stable kidney function and who are undergoing cardiac surgery procedures with an expected CPB duration >90 min. After randomisation, 80 parts per million (ppm) NO (intervention group) or 80 ppm nitrogen (N 2 , control group) are added to the gas mixture. Test gases (N 2  or NO) are delivered during CPB and for 24 hours after surgery. The primary study outcome is the occurrence of AKI among study groups. Key secondary outcomes include AKI severity, occurrence of renal replacement therapy, major adverse kidney events at 6 weeks after surgery and mortality. We are recruiting 250 patients, allowing detection of a 35% AKI relative risk reduction, assuming a two-sided error of 0.05.
ETHICS AND DISSEMINATION


The Partners Human Research Committee approved this trial. Recruitment began in February 2017. Dissemination plans include presentations at scientific conferences, scientific publications and advertising flyers and posters at Massachusetts General Hospital.
TRIAL REGISTRATION NUMBER


NCT02836899.",2019,Levels of intravascular haemolysis are strongly associated with postoperative AKI and with prolonged (>90 min) use of cardiopulmonary bypass (CPB).,"['patients with endothelial dysfunction', 'patients with endothelial dysfunction, stable kidney function and who are undergoing cardiac surgery procedures with an expected CPB duration', 'patients with cardiovascular risk factors', 'young cardiac surgical patients with rheumatic fever', 'cardiac surgical patients with endothelial dysfunction']","['NO (intervention group) or 80 ppm', 'Test gases (N 2  or NO', 'nitric oxide gas']","['occurrence of AKI', 'AKI severity, occurrence of renal replacement therapy, major adverse kidney events at 6 weeks after surgery and mortality', 'Levels of intravascular haemolysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018821', 'cui_str': 'Surgical Procedures, Heart'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035436', 'cui_str': 'Rheumatic Arthritis'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0235574', 'cui_str': 'Intravascular hemolysis (finding)'}]",,0.1807,Levels of intravascular haemolysis are strongly associated with postoperative AKI and with prolonged (>90 min) use of cardiopulmonary bypass (CPB).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Marrazzo', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Spina', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zadek', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Tenzing', 'Initials': 'T', 'LastName': 'Lama', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Changhan', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Larson', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rezoagli', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Bittner', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Shelton', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Serguei', 'Initials': 'S', 'LastName': 'Melnitchouk', 'Affiliation': 'Department of Cardiac surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Roy', 'Affiliation': 'Department of Cardiac surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Thoralf M', 'Initials': 'TM', 'LastName': 'Sundt', 'Affiliation': 'Department of Cardiac surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Riley', 'Affiliation': 'Department of Surgery, Cardiac Surgery, Perfusion Services, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Purris', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Respiratory Care Services, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Respiratory Care Services, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Respiratory Care, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Taylor B', 'Initials': 'TB', 'LastName': 'Thompson', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bonventre', 'Affiliation': ""Department of Medicine, Division of Renal Medicine, Brigham and Women's Hospital Department of Medicine, Boston, Massachusetts, USA.""}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Zapol', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Ichinose', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berra', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2018-026848']
552,31278094,The effect of resveratrol supplementation on the expression levels of factors associated with cellular senescence and sCD163/sTWEAK ratio in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomised clinical trial.,"INTRODUCTION


Over the past decades, the number of people with type 2 diabetes (T2D) has increased globally. One of the major complications in these patients is cardiovascular disease; it seems that the cell proliferation inhibition can improve vascular function in these patients. It is proposed that peroxisome proliferator-activated receptor alpha (PPARα) can induce cell cycle arrest via cyclin-dependent kinase inhibitor 2A (p16) activation. Also, it has been shown that phosphorylated tumour suppressor protein p53 is involved in cell senescence by cyclin-dependent kinase inhibitor 1 (p21) upregulation. Resveratrol is a natural polyphenol and appears to improve the vascular function through the mentioned pathways. We will aim to evaluate the effects of resveratrol supplementation on mRNA expression of PPARα, p53, p21 and p16 in patients with T2D. We will also measure serum levels of cluster of differentiation 163 (CD163) and tumour necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) as the indicators of cardiovascular status.
METHODS AND ANALYSIS


Seventy-two subjects suffering from T2D will participate in this double-blind randomised parallel placebo-controlled clinical trial. Participants will be randomly assigned to receive 1000 mg/day trans-resveratrol or placebo (methyl cellulose) for 8 weeks. The mRNA expression levels of PPARα, p53, p21 and p16 genes will be assessed using real-time PCR and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits at baseline and the end of the study. Clinical outcome parameters (glycaemic and lipid profiles and body composition) will also be measured before and after study duration.
ETHICS AND DISSEMINATION


The study is performed in agreement with the Declaration of Helsinki and is approved by the Ethics Committee of the Shahid Sadoughi University of Medical Sciences (no: ir.ssu.sph.rec.1396.120). The results will be published in scientific journals.
TRIAL REGISTRATION NUMBER


IRCT20171118037528N1; Pre-results.",2019,"The mRNA expression levels of PPARα, p53, p21 and p16 genes will be assessed using real-time PCR and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits at baseline and the end of the study.","['Seventy-two subjects suffering from T2D will participate', 'patients with T2D', 'patients with type 2 diabetes mellitus']","['1000\u2009mg/day trans-resveratrol or placebo (methyl cellulose', 'placebo', 'resveratrol supplementation']","['serum levels of cluster of differentiation 163 (CD163) and tumour necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK', 'vascular function', 'Clinical outcome parameters (glycaemic and lipid profiles and body composition', 'real-time PCR and serum CD163 and TWEAK levels']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1101322', 'cui_str': 'trans-Resveratrol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025729', 'cui_str': 'Methylcellulose'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}]",72.0,0.332521,"The mRNA expression levels of PPARα, p53, p21 and p16 genes will be assessed using real-time PCR and serum CD163 and TWEAK levels will be measured using commercially available ELISA kits at baseline and the end of the study.","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Tabatabaie', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Sheikhha', 'Affiliation': 'Department of Genetics, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': 'Yazd Diabetic Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Toupchian', 'Affiliation': 'Department of Nutrition and Public Health, School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi-Nazari', 'Affiliation': 'Biological Sciences and Technology Institute, Malek Ashtar University of Technology, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",BMJ open,['10.1136/bmjopen-2018-026337']
553,31340957,The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle.,"INTRODUCTION


At present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce.
METHODS AND ANALYSIS


We perform a randomised controlled non-inferiority trial among five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium. Women eligible for artificial insemination with donor sperm are included. We perform six cycles of artificial insemination with donor sperm within a time horizon of 8 months comparing intrauterine insemination in the natural cycle with intracervical insemination in the natural cycle. The primary outcome is ongoing pregnancy leading to live birth conceived within eight months after randomisation. Secondary outcomes are clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500 g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs. To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.
ETHICS AND DISSEMINATION


The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on research involving human subjects (47330-018-13). The boards of the participating hospitals approved the study. Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER


NTR4462.",2019,"To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.
","['women undergoing artificial insemination with donor sperm are scarce', 'Women eligible for artificial insemination with donor sperm are included', '208 women per arm', 'five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium']","['artificial insemination with donor sperm within a time horizon of 8\u2009months comparing intrauterine insemination', 'intrauterine insemination']","['ongoing pregnancy leading to live birth conceived within eight\u2009months after randomisation', 'clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500\u2009g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021589', 'cui_str': 'AIH'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0021589', 'cui_str': 'AIH'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",208.0,0.145434,"To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.
","[{'ForeName': 'Petronella', 'Initials': 'P', 'LastName': 'Kop', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands p.a.kop@amc.uva.nl.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Gynaecology and Obstetrics, Rijnstate, Arnhem, Gelderland, Netherlands.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and gynaecology, Monash University Central Clinical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Bernardus', 'Affiliation': 'Fertility clinic, Nij Barrahus, Wolvega, Netherlands.'}, {'ForeName': 'Michael De', 'Initials': 'M', 'LastName': 'Brucker', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussel, Belgium.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Janssens', 'Affiliation': 'Clinical Chemistry and Haematology, Hospital Rijnstate, Arnhem, Gelderland, Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Cohlen', 'Affiliation': 'Obstetrics and Gynaecology, Isala Hospitals, Zwolle, Overijssel, Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Pieters', 'Affiliation': 'Fertility clinic, Vivaneo Medisch Centrum Kinderwens, Leiderdorp, Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Repping', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Fulco', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Monique H', 'Initials': 'MH', 'LastName': 'Mochtar', 'Affiliation': 'Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-026065']
554,31345964,"Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study.","INTRODUCTION


Older persons with functional limitations often need assistance from home care staff to thrive and continue to live in their home environments. Reablement, a proactive, preventative approach administered by home care staff, stimulating active engagement of the older person, is often recommended. Even though reablement has a potential to become a new rehabilitation model and has been implemented in different countries in various degrees, there is a lack of knowledge regarding the process of establishing reablement, the theoretical underpinnings and the conditionality and outcomes in different contexts. This knowledge is needed before full-scale recommendations can be made for implementation in specific contexts.
AIM


This study protocol aims to present a feasibility study of the intervention, ASSIST 1.0, a theory-based reablement programme, which includes coaching of home care staff and digitally based smart products, in a Swedish context.
METHODS AND ANALYSIS


This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention programme regarding fidelity, reach and dose, and potential outcomes by using a pretest and post-test design involving an intervention group and a control group (n=30) of older persons living at home, needing home care services. Qualitative interviews with home care staff delivering ASSIST and the older adults receiving the intervention as well as their significant others will be conducted to explore aspects affecting the intervention.
ETHICS AND DISSEMINATION


This study has been approved by the regional ethics board. The results of the feasibility study will form the base for refinement of the ASSIST programme and for the subsequent planning of a full-scale randomised controlled trial investigating the effect of the programme on a larger scale. Dissemination will include peer-reviewed publications and presentations at national and international conferences as well as information to involved stakeholders.
TRIAL REGISTRATION NUMBER


NCT03505619.",2019,"This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention programme regarding fidelity, reach and dose, and potential outcomes by using a pretest and post-test design involving an intervention group and a control group (n=30) of older persons living at home, needing home care services.","['n=30) of older persons living at home, needing home care services', 'Older persons with functional limitations', 'older, community-dwelling persons in Sweden (ASSIST 1.0']","['intervention addressing a reablement programme', 'control group']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.054499,"This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention programme regarding fidelity, reach and dose, and potential outcomes by using a pretest and post-test design involving an intervention group and a control group (n=30) of older persons living at home, needing home care services.","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Bergström', 'Affiliation': 'Division of Occupational Therapy, Department of Neurobiology Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Borell', 'Affiliation': 'Division of Occupational Therapy, Department of Neurobiology Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Meijer', 'Affiliation': 'School of Engineering Sciences in Chemistry, Biotechnology and Health (CBH), Biomedical Engineering and Health Systems, Health Informatics and Logistics, Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Guidetti', 'Affiliation': 'Division of Occupational Therapy, Department of Neurobiology Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden susanne.guidetti@ki.se.'}]",BMJ open,['10.1136/bmjopen-2018-025870']
555,31289068,"RAIN study: a protocol for a randomised controlled trial evaluating efficacy, safety and cost-effectiveness of intravenous-to-oral antibiotic switch therapy in neonates with a probable bacterial infection.","INTRODUCTION


High morbidity and mortality rates of proven bacterial infection are the main reason for substantial use of intravenous antibiotics in neonates during the first week of life. In older children, intravenous-to-oral switch after 48 hours of intravenous therapy has been shown to have many advantages and is nowadays commonly practised. We, therefore, aim to evaluate the effectiveness, safety and cost-effectiveness of an early intravenous-to-oral switch in neonates with a probable bacterial infection.
METHODS AND ANALYSIS


We present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0-28 days of age) with a probable bacterial infection. Five hundred and fifty patients will be recruited in 17 hospitals in the Netherlands. After 48 hours of intravenous treatment, they will be assigned to either continue with intravenous therapy for another 5 days (control) or switch to amoxicillin/clavulanic acid suspension (intervention). Both groups will be treated for a total of 7 days. The primary outcome will be bacterial (re)infection within 28 days after treatment completion. Secondary outcomes are the pharmacokinetic profile of oral amoxicillin/clavulanic acid, the impact on quality of life, cost-effectiveness, impact on microbiome development and additional yield of molecular techniques in diagnosis of probable bacterial infection.
ETHICS AND DISSEMINATION


This study has been approved by the Medical Ethics Committee of the Erasmus Medical Centre. Results will be presented in peer-reviewed journals and at international conferences.
TRIAL REGISTRATION NUMBER


NCT03247920.",2019,We present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0-28 days of age) with a probable bacterial infection.,"['older children', 'Five hundred and fifty patients will be recruited in 17 hospitals in the Netherlands', 'neonates with a probable bacterial infection', 'neonates (0-28 days of age) with a probable bacterial infection']","['amoxicillin/clavulanic acid suspension (intervention', 'intravenous antibiotics', 'early intravenous-to-oral antibiotic switch', 'intravenous-to-oral antibiotic switch therapy']","['effectiveness, safety and cost-effectiveness', 'bacterial (re)infection', 'pharmacokinetic profile of oral amoxicillin/clavulanic acid, the impact on quality of life, cost-effectiveness, impact on microbiome development and additional yield of molecular techniques in diagnosis of probable bacterial infection', 'efficacy, safety and cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",550.0,0.208481,We present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0-28 days of age) with a probable bacterial infection.,"[{'ForeName': 'Fleur M', 'Initials': 'FM', 'LastName': 'Keij', 'Affiliation': ""Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'René F', 'Initials': 'RF', 'LastName': 'Kornelisse', 'Affiliation': ""Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Nico G', 'Initials': 'NG', 'LastName': 'Hartwig', 'Affiliation': 'Pediatrics, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Mauff', 'Affiliation': 'Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': ""Pediatric Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Allegaert', 'Affiliation': ""Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Gerdien A', 'Initials': 'GA', 'LastName': 'Tramper-Stranders', 'Affiliation': ""Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",BMJ open,['10.1136/bmjopen-2018-026688']
556,31353231,Impact of lipoprotein apheresis on thrombotic parameters in patients with refractory angina and raised lipoprotein(a): Findings from a randomized controlled cross-over trial.,"BACKGROUND


Raised lipoprotein(a) [Lp(a)] is a cardiovascular risk factor common in patients with refractory angina. The apolipoprotein(a) component of Lp(a) exhibits structural homology with plasminogen and can enhance thrombosis and impair fibrinolysis.
OBJECTIVES


The objective of the study was to assess the effect of lipoprotein apheresis on markers of thrombosis and fibrinolysis in patients with high Lp(a).
METHODS


In a prospective, single-blind, crossover trial, 20 patients with refractory angina and raised Lp(a) > 50 mg/dL were randomized to three months of weekly lipoprotein apheresis or sham. Blood taken before and after apheresis/sham was assessed using the Global Thrombosis Test, to assess time taken for in vitro thrombus formation (occlusion time) and endogenous fibrinolysis (lysis time), as well as von Willebrand Factor, fibrinogen, D-dimer, thrombin/anti-thrombin III complex, prothrombin fragments 1 + 2, and thrombin generation assays.
RESULTS


Lp(a) was significantly reduced by apheresis (100.2 [interquartile range {IQR}, 69.6143.0] vs 24.8 [17.2,34.0] mg/dL, P = .0001) but not by sham (P = .0001 between treatment arms). Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847 [685,1302] s, P = .0006) reflecting enhanced fibrinolysis, without corresponding changes with sham. Apheresis, but not sham, reduced von Willebrand Factor (149 [89.0, 164] vs 64.2 [48.5, 89.8] IU/dL, P = .0001), and fibrinogen (3.12 ± 0.68 vs 2.20 ± 0.53 g/L, P < .0001), and increased prothrombin fragments 1 + 2 (158.16 [128.77, 232.09] vs 795.12 [272.55, 1201.00] pmol/L, P = .0006). There was no change in D-dimer, thrombin/anti-thrombin III complex, or thrombin generation assay with apheresis or sham.
CONCLUSION


Lipoprotein apheresis reduces Lp(a) and improves some thrombotic and fibrinolytic parameters in patients with refractory angina.",2019,"Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847","['patients with refractory angina and raised lipoprotein(a', '20 patients with refractory angina and raised Lp(a)\xa0', 'patients with refractory angina', 'patients with high Lp(a']","['Raised lipoprotein(a) [Lp(a', 'lipoprotein apheresis or sham', 'lipoprotein apheresis', 'Lipoprotein apheresis']","['thrombotic parameters', 'prothrombin fragments', 'reduced von Willebrand Factor', 'platelet reactivity and reduced lysis time', 'thrombotic and fibrinolytic parameters', 'time taken for in\xa0vitro thrombus formation (occlusion time) and endogenous fibrinolysis (lysis time), as well as von Willebrand Factor, fibrinogen, D-dimer, thrombin/anti-thrombin III complex, prothrombin fragments 1\xa0+\xa02, and thrombin generation assays', 'Apheresis prolonged occlusion time', 'Lp(a', 'D-dimer, thrombin/anti-thrombin III complex, or thrombin generation assay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",,0.436947,"Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847","[{'ForeName': 'Tina Z', 'Initials': 'TZ', 'LastName': 'Khan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Deepa J', 'Initials': 'DJ', 'LastName': 'Arachchillage', 'Affiliation': 'Department of Haematology, Royal Brompton and Imperial College Healthcare NHS Trust and Imperial College London, London, UK.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Ahnström', 'Affiliation': 'Department of Haematology, Royal Brompton and Imperial College Healthcare NHS Trust and Imperial College London, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pottle', 'Affiliation': 'Cardiology Department, Harefield Hospital, Harefield, UK.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Barbir', 'Affiliation': 'Cardiology Department, Harefield Hospital, Harefield, UK. Electronic address: M.Barbir@rbht.nhs.uk.'}, {'ForeName': 'Dudley J', 'Initials': 'DJ', 'LastName': 'Pennell', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.06.009']
557,31340956,"Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)-integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial.","INTRODUCTION


Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England's annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.
METHODS AND ANALYSIS


A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to 'integrated GP care plus treatment as usual' or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks' postrandomisation, using a mixed-methods approach.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.
TRIAL REGISTRATION NUMBER


NCT02444520; Pre-results.",2019,"A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice.",['Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London'],"['system change and evaluation (PRINCE)-integrated GP care', 'GP training']",[],"[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],240.0,0.138004,"A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice.","[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Persistent Physical Symptoms Research and Treatment Unit, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': ""Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ferreira', 'Affiliation': ""Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Mosweu', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': ""Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-025513']
558,31422134,Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque.,"OBJECTIVES


The goal of this study was to determine whether ticagrelor reduces high-sensitivity troponin I concentrations in patients with established coronary artery disease and high-risk coronary plaque.
BACKGROUND


High-risk coronary atherosclerotic plaque is associated with higher plasma troponin concentrations suggesting ongoing myocardial injury that may be a target for dual antiplatelet therapy.
METHODS


In a randomized, double-blind, placebo-controlled trial, patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients were randomized (1:1) to receive ticagrelor 90 mg twice daily or matched placebo. The primary endpoint was troponin I concentration at 30 days in patients with increased coronary  18 F-fluoride uptake.
RESULTS


In total, 202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis. In patients with increased coronary  18 F-fluoride uptake (120 of 191), there was no evidence that ticagrelor had an effect on plasma troponin concentrations at 30 days (ratio of geometric means for ticagrelor vs. placebo: 1.11; 95% confidence interval: 0.90 to 1.36; p = 0.32). Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
CONCLUSIONS


Dual antiplatelet therapy with ticagrelor did not reduce plasma troponin concentrations in patients with high-risk coronary plaque, suggesting that subclinical plaque thrombosis does not contribute to ongoing myocardial injury in this setting. (Dual Antiplatelet Therapy to Reduce Myocardial Injury [DIAMOND]; NCT02110303).",2020,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","['Patients', 'patients with high-risk coronary plaque', '202 patients were randomized to treatment, and 191 met the pre-specified criteria for inclusion in the primary analysis', 'patients with established coronary artery disease and high-risk coronary plaque', 'patients with multivessel coronary artery disease underwent coronary  18 F-fluoride positron emission tomography/coronary computed tomography scanning and measurement of high-sensitivity cardiac troponin I. Patients']","['ticagrelor', 'placebo', 'Ticagrelor', 'ticagrelor 90\xa0mg twice daily or matched placebo']","['troponin concentrations', 'Myocardial Injury', 'plasma troponin concentrations', 'troponin I concentration', 'sensitivity troponin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",202.0,0.613089,"Over 1 year, ticagrelor had no effect on troponin concentrations in patients with increased coronary  18 F-fluoride uptake (ratio of geometric means: 0.86; 95% confidence interval: 0.63 to 1.17; p = 0.33).
","[{'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: alastairmoss@gmail.com.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mhairi K', 'Initials': 'MK', 'LastName': 'Doris', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jack P M', 'Initials': 'JPM', 'LastName': 'Andrews', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rachael O', 'Initials': 'RO', 'LastName': 'Forsythe', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cartlidge', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Tania A', 'Initials': 'TA', 'LastName': 'Pawade', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Daghem', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Raftis', 'Affiliation': 'Medical Research Council Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forsyth', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steff C', 'Initials': 'SC', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.05.023']
559,31542245,"Genetic susceptibility, lifestyle intervention and glycemic changes among women with prior gestational diabetes.","AIMS


Women with prior gestational diabetes mellitus (GDM) or high genetic susceptibility are prone to development of type 2 diabetes. We examined whether a lifestyle intervention modified the genetic effect on changes in glycemic markers among women with prior GDM.
RESEARCH DESIGN AND METHODS


This study included 560 women with prior GDM from a randomized controlled trial, the Tianjin Gestational Diabetes Mellitus Prevention Program, who were assigned into an intervention arm (improved physical activity and healthy dietary intakes) or a control arm. We assessed associations of GDM related genetic variants in/near the CDKAL1 (rs7754840) and MTNR1B (rs10830962) genes with changes in fasting levels of glucose and insulin, β-cell function (HOMA-B) and insulin resistance (HOMA-IR) at 1 year and 2 years after the baseline.
RESULTS


We found significant interactions between CDKAL1 variant rs7754840 and lifestyle intervention on changes in fasting insulin and HOMA-IR at 1 year (P for interactions = 0.008 and 0.006, respectively). The GDM-increasing C allele was associated with a 0.07-unit greater increase in fasting insulin (P = 0.048) and HOMA-IR (P = 0.045) in the control group, while opposite-directional associations were observed in the intervention group; women with the C allele seemed to decrease more in these glycemic markers than the non-C-carriers (both P ≤ 0.06). The interactions between the CDKAL1 genetic variant and lifestyle intervention on changes in fasting insulin (P = 0.035) and HOMA-IR (P = 0.024) remained significant over the 2-year period, even though the effects of lifestyle intervention were attenuated at 2-year. The MTNR1B variant rs10830962 did not show interaction with lifestyle intervention on changes in the glycemic markers.
CONCLUSIONS


Healthy lifestyle intervention may be beneficial for women with the GDM predisposing CDKAL1 genetic variant in improvement of insulin resistance.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT01554358. URL OF REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01554358.",2020,"The MTNR1B variant rs10830962 did not show interaction with lifestyle intervention on changes in the glycemic markers.
","['560 women with prior GDM from a randomized controlled trial, the Tianjin Gestational Diabetes Mellitus Prevention Program', 'women with prior gestational diabetes', 'women with prior GDM', 'Women with prior gestational diabetes mellitus (GDM']","['intervention arm (improved physical activity and healthy dietary intakes) or a control arm', 'lifestyle intervention']","['fasting levels of glucose and insulin, β-cell function (HOMA-B) and insulin resistance (HOMA-IR', 'glycemic markers', 'fasting insulin', 'fasting insulin and HOMA-IR', 'HOMA-IR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",560.0,0.0338199,"The MTNR1B variant rs10830962 did not show interaction with lifestyle intervention on changes in the glycemic markers.
","[{'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA; Department of Obstetrical, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Leishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Tianjin Women's and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Huikun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Tianjin Women's and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA; Department of Public Health Laboratory Sciences, West China School of Public Health, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women's and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women's and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Pennington Biomedical Research Center, Baton Rouge, LA, USA; Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital South Campus, Shanghai, China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: lqi1@tulane.edu.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.08.032']
560,31366643,Acupuncture for chronic neck pain with sensitive points: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Chronic neck pain is a challenging condition to treat in clinical practice and has a considerable impact on quality of life and disability. According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state. Stimulation of such sensitive points may lead to disease improvement and improved clinical efficacy. This study aims to evaluate the efficacy and safety of needling at sensitive acupoints in providing pain relief, improvement of cervical vertebral function and quality of life in patients with chronic neck pain.
METHODS AND ANALYSIS


This multicentre, randomised controlled, explanatory and parallel clinical trial will include 716 patients with chronic neck pain. Study participants will be randomly assigned in a 1:1:1:1 ratio to four treatment groups: the highly sensitive acupoints group, low/non-sensitive acupoints group, sham acupuncture group and waiting-list control group. The primary outcome will be the change in the visual analogue scale score for neck pain from baseline to 4 weeks. Secondary outcomes will be the Northwick Park Neck Pain Questionnaire and McGill pain questionnaire, 12-item Short-Form health survey, Neck Disability Index, changes in the pressure pain threshold, range of cervical motion, Self-Rating Anxiety Scale, Self-Rating Depression Scale and adverse events before treatment, post-treatment, and at 4, 8, 12, 16 and 20 weeks post-treatment. The intention-to-treat approach will be used in the statistical analysis. Group comparisons will be undertaken using χ 2  tests for categorical characteristics, and analysis of variance for continuous variables to analyse whether acupuncture in the highly sensitive acupoints group achieves better treatment outcomes than in each of the other three groups.
ETHICS AND DISSEMINATION


Ethical approval of this study has been granted by the local Institutional Review Board (ID: 2017 KL-038). The outcomes of the trial will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


ChiCTR1800016371; Pre-results.",2019,"According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state.","['chronic neck pain with sensitive points', 'patients with chronic neck pain', '716 patients with chronic neck pain']","['highly sensitive acupoints group, low/non-sensitive acupoints group, sham acupuncture group and waiting-list control group', 'needling at sensitive acupoints', 'Acupuncture']","['clinical efficacy', 'visual analogue scale score for neck pain', 'quality of life and disability', 'efficacy and safety', 'Northwick Park Neck Pain Questionnaire and McGill pain questionnaire, 12-item Short-Form health survey, Neck Disability Index, changes in the pressure pain threshold, range of cervical motion, Self-Rating Anxiety Scale, Self-Rating Depression Scale and adverse events', 'cervical vertebral function and quality of life']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439822', 'cui_str': 'Highly sensitive (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031843', 'cui_str': 'function'}]",716.0,0.212657,"According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state.","[{'ForeName': 'Mingsheng', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Guoyan', 'Initials': 'G', 'LastName': 'Geng', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xingsha', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Mingxi', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jiarong', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Dingjun', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Fan-Rong', 'Initials': 'FR', 'LastName': 'Liang', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",BMJ open,['10.1136/bmjopen-2018-026904']
561,31377034,Standardized reporting systems for computed tomography coronary angiography and calcium scoring: A real-world validation of CAD-RADS and CAC-DRS in patients with stable chest pain.,"OBJECTIVES


To assess the prognostic implications of standardized reporting systems for coronary computed tomography angiography (CCTA) and coronary artery calcium scores (CACS) in patients with stable chest pain.
BACKGROUND


The Coronary Artery Disease Reporting And Data System (CAD-RADS) and Coronary Artery Calcium - Data and Reporting System (CAC-DRS) aim to improve communication of CACS and CCTA results, but its influence on prognostication is unknown.
METHODS


Images from 1769 patients who underwent CCTA as part of the Scottish Computed Tomography of the HEART (SCOT-HEART) multi-center randomized controlled trial were assessed. CACS were classified as CAC-DRS 0 to 3 based on Agatston scores. CCTA were classified as CAD-RADS 0 to 5 based on the most clinically relevant finding per patient. The primary outcome was the five-year events of fatal and non-fatal myocardial infarction.
RESULTS


Patients had a mean age of 58 ± 10 years and 56% were male. CAC-DRS 0, 1, 2 and 3 occurred in 642 (36%), 510 (29%), 239 (14%) and 379 (21%) patients respectively. CAD-RADS 0, 1, 2, 3, 4A, 4B and 5 occurred in 622 (35%), 327 (18%), 211 (12%), 165 (9%), 221 (12%), 42 (2%) and 181 (10%) patients respectively. Patients classified as CAC-DRS 3 were at an increased risk of fatal or non-fatal myocardial infarction compared to CAC-DRS 0 patients (hazard ratio (HR) 9.41; 95% confidence interval (CI) 3.24, 27.31; p < 0.001). Patients with higher CAD-RADS categories were at an increased risk of fatal or non-fatal myocardial infarction, with patients classified as CAD-RADS 4B at the highest risk compared to CAD-RADS 0 patients (HR 19.14; 95% CI 4.28, 85.53; p < 0.001).
CONCLUSION


Patients with higher CAC-DRS and CAD-RADS scores were at increased risk of subsequent fatal and non-fatal myocardial infarction. This confirms that the classification provides additional prognostic discrimination for future coronary heart disease events.",2020,"Patients classified as CAC-DRS 3 were at an increased risk of fatal or non-fatal myocardial infarction compared to CAC-DRS 0 patients (hazard ratio (HR) 9.41; 95% confidence interval (CI) 3.24, 27.31; p < 0.001).","['patients with stable chest pain', 'Images from 1769 patients who underwent CCTA as part of the Scottish Computed Tomography of the HEART (SCOT-HEART) multi-center randomized controlled trial were assessed', 'Patients had a mean age of 58\u202f±\u202f10 years and 56% were male']","['CAC-DRS', 'coronary computed tomography angiography (CCTA) and coronary artery calcium scores (CACS']","['CAC-DRS and CAD-RADS scores', 'risk of fatal or non-fatal myocardial infarction', 'five-year events of fatal and non-fatal myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}]","[{'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1769.0,0.0834301,"Patients classified as CAC-DRS 3 were at an increased risk of fatal or non-fatal myocardial infarction compared to CAC-DRS 0 patients (hazard ratio (HR) 9.41; 95% confidence interval (CI) 3.24, 27.31; p < 0.001).","[{'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK; Edinburgh Imaging Facility QMRI, University of Edinburgh, Edinburgh, UK. Electronic address: https://twitter.com/imagingmedsci.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Moss', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dweck', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Pawade', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Shirjel', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Maroules', 'Affiliation': 'Department of Radiology, Naval Medical Center, Portsmouth, VA, USA\u2028.'}, {'ForeName': 'Edwin Jr', 'Initials': 'EJ', 'LastName': 'van Beek', 'Affiliation': 'Edinburgh Imaging Facility QMRI, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Cury', 'Affiliation': 'Miami Cardiac and Vascular Institute, Baptist Health of South Florida, Miami, FL, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Nicol', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust Departments of Cardiology and Radiology, London, UK; National Heart and Lung Institute, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of Edinburgh/British Heart Foundation Centre for Cardiovascular Science, Edinburgh, UK; Edinburgh Imaging Facility QMRI, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Glasgow Clinical Research Imaging Facility, Queen Elizabeth University Hospital, Glasgow, Scotland, UK; Glasgow University, Glasgow, Scotland, UK.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.07.010']
562,31025748,"A double-blind, randomized, placebo-controlled, phase II trial of baricitinib for systemic lupus erythematosus: how to optimize lupus trials to examine effects on cutaneous lupus erythematosus.",,2019,,"['systemic lupus erythematosus', 'cutaneous lupus erythematosus']","['baricitinib', 'placebo']",[],"[{'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0024137', 'cui_str': 'Lupus Erythematosus, Cutaneous'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.522571,,"[{'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Werth', 'Affiliation': 'Corporal Michael J. Crescenz VAMC, Philadelphia, PA, U.S.A.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Merrill', 'Affiliation': 'Oklahoma Medical Research Foundation, Oklahoma City, OK, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17344']
563,31215440,Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders.,"BACKGROUND


The study design and protocol that underpin a randomised controlled trial (RCT) are critical for the ultimate success of the trial. Although RCTs are considered the gold standard for research, there are multiple threats to their validity such as participant recruitment and retention, identifying a meaningful change, and non-adherence to the protocol. For clinical RCTs, involving patients and clinicians in protocol design provides the opportunity to develop research protocols that are meaningful to their target audience and may help overcome some of the inherent threats in conducting RCTs. However, the majority of protocols do not describe the methodology underpinning their development, limiting the amount of learned experience shared between research groups.
METHOD


With the purpose of reporting a collaborative approach towards developing a protocol, we present the findings from three sequential workshops that were conducted with the aim of developing a protocol to investigate the feasibility of adding a computerised test of attention, impulsivity and activity (QbTest) to medication management of children and young people with Attention deficit hyperactivity disorder (ADHD). Based on previous qualitative interviews with clinicians and families, each workshop prioritised topics for focused discussion. Information from the workshops was fed back to the participants for reflection in advance of the next workshop.
RESULTS


The workshops involved 21 multi-disciplinary ADHD experts, including clinicians, patient and public involvement (PPI) members, parents of young people with ADHD and researchers. The consensus workshops addressed key research issues such as: the most relevant outcome measures/ resource drivers; methods and time points for data collection; and the clinical protocol for utilising the QbTest, including when best to use this within the medication management process. The resulting protocol details a feasibility RCT design describing these factors.
CONCLUSION


Protocols which are co-developed may help overcome some of the risks associated with RCT completion (e.g. recruitment, retention, protocol adherence) and help prioritise outcomes of greater relevance to the populations under study. The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03368573, 11th December 2017 (retrospectively registered).",2019,"The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.
","['11th December 2017 (retrospectively registered', 'children and young people with Attention deficit hyperactivity disorder (ADHD', 'young people with ADHD and researchers']",[],[],"[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",[],[],,0.0747261,"The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.
","[{'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK. charlotte.hall@nottingham.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Selby', 'Affiliation': 'Department of Community Paediatrics, Medway NHS Foundation Trust, Kent, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Acting Consultant Community Paediatrics, Grantham and District Hospital, United Lincolnshire Hospitals NHS Trust, Grantham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'Child and Adolescent, Developmental Psychiatry, School of Medicine, University of Nottingham and CANDAL (Centre for ADHD and Neuro-developmental Disorders across the Lifespan), Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'Devlopmental Psychiatry Queens Medical Centre, School of Medicine, and MindTech, Institute of Mental, University of Nottingham, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Groom', 'Affiliation': 'Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.'}]",BMC medical research methodology,['10.1186/s12874-019-0772-2']
564,31217008,How different online recruitment methods impact on recruitment rates for the web-based coortesnaweb project: a randomised trial.,"BACKGROUND


The number of web-based E-epidemiologic studies using online recruitment methods is increasing. However, the optimal online recruitment method in terms of maximizing recruitment rates is still unknown. Our aim was to compare the recruitment rates of three online recruitment methods and to describe how these rates differ according to individual's socioeconomic and demographic factors.
METHODS


A total of 2394 members of the 1993 Pelotas birth cohort that provided an e-mail address, a Facebook name, and a WhatsApp number during a face-to-face follow-up were randomly allocated to be recruited by e-mail, Facebook or WhatsApp (798 individuals per method). This was a parallel randomised trial applying a block randomisation (block size = 3). Between January and February 2018, we sent messages inviting them to register into the web-based coortesnaweb platform. Recruitment rates were calculated for each method, and stratified according to the individual's socioeconomic and demographic characteristics. We also analysed absolute and relative inequalities on recruitment according to schooling and socioeconomic position.
RESULTS


Out of the 2394 individuals analysed, 642 registered into the platform. The overall recruitment rate was 26.8%. Recruitment rates for women were almost 10 percentage points higher compared to men. Facebook was the most effective recruitment method, as 30.6% of those invited through the social network were recruited. Recruitment rates of e-mail and WhatsApp were similar (recruitment rate = 24.9%). E-mail and Facebook were the most effective recruitment methods to invite highly educated and wealthier individuals. However, sending e-mails to recruit individuals also reflected in the highest inequalities according to schooling and socioeconomic position. In contrast, the lowest inequalities according to socioeconomic position were observed using Facebook.
CONCLUSIONS


Facebook was the most effective online recruitment method, also achieving the most equitable sample in terms of schooling and socioeconomic position. The effectiveness of online recruitment methods depends on the characteristics of the sample. It is important to know the profile of the target sample in order to decide which online recruitment method to use.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials, identifier: RBR-3dv7gc , retrospectively registered in 10 April 2018.",2019,Recruitment rates of e-mail and WhatsApp were similar (recruitment rate = 24.9%).,"['2394 individuals analysed, 642 registered into the platform', 'A total of 2394 members of the 1993 Pelotas birth cohort that provided an e-mail address, a Facebook name, and a WhatsApp number during a face-to-face follow-up']","['Facebook or WhatsApp', 'Facebook']","['Recruitment rates', 'Recruitment rates of e-mail and WhatsApp', 'overall recruitment rate']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2394.0,0.222009,Recruitment rates of e-mail and WhatsApp were similar (recruitment rate = 24.9%).,"[{'ForeName': 'Cauane', 'Initials': 'C', 'LastName': 'Blumenberg', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil. cauane.epi@gmail.com.'}, {'ForeName': 'Ana Maria Baptista', 'Initials': 'AMB', 'LastName': 'Menezes', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gonçalves', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil.'}, {'ForeName': 'Maria Cecília Formoso', 'Initials': 'MCF', 'LastName': 'Assunção', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil.'}, {'ForeName': 'Fernando César', 'Initials': 'FC', 'LastName': 'Wehrmeister', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil.'}, {'ForeName': 'Aluísio J D', 'Initials': 'AJD', 'LastName': 'Barros', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, 1160 Marechal Deodoro St. - 3rd floor - 96020-220, Pelotas, Brazil.'}]",BMC medical research methodology,['10.1186/s12874-019-0767-z']
565,30869182,Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial.,"AIM


To evaluate the efficacy and safety of colchicine for improving metabolic and inflammatory outcomes in people with obesity and metabolic syndrome (MetS).
MATERIALS AND METHODS


Adults with obesity and MetS, but who did not have diabetes, were randomized to colchicine 0.6 mg or placebo capsules twice daily for 3 months. The primary outcome was change in insulin sensitivity (S I  ) as estimated by insulin-modified frequently sampled intravenous glucose tolerance tests. Secondary outcomes included changes in other metabolic variables and inflammatory markers.
RESULTS


Of 40 participants randomized (21 colchicine, 19 placebo), 37 completed the trial. Compared with placebo, colchicine significantly reduced C-reactive protein (P <0.005), erythrocyte sedimentation rate (P <0.01), white blood cell count (P <0.005), and absolute neutrophil count (P <0.001). Change in S I  was not significantly different between colchicine and placebo arms (difference: +0.21 × 10 -5  ; CI -1.70 to +2.13 × 10 -5  min -1  mU -1  mL; P = 0.82). However, changes in some secondary outcomes, including homeostatic model assessment of insulin resistance (P = 0.0499), fasting insulin (P = 0.07) and glucose effectiveness (P = 0.08), suggested metabolic improvements in the colchicine versus placebo group. Adverse events were generally mild and similar in both groups.
CONCLUSIONS


This pilot study found colchicine significantly improved obesity-associated inflammatory variables and showed a good safety profile among adults with obesity and MetS who did not have diabetes. These results suggest a larger, adequately powered study should be conducted to determine whether colchicine improves insulin resistance and other measures of metabolic health in at-risk individuals.",2019,"Compared with placebo, colchicine significantly reduced C-reactive protein (P <0.005), erythrocyte sedimentation rate (P <0.01), white blood cell count (P <0.005), and absolute neutrophil count (P <0.001).","['40 participants randomized (21', 'Adults with obesity and MetS, but who did not have diabetes', 'adults with obesity and MetS who did not have diabetes', 'adults with metabolic syndrome', 'people with obesity and metabolic syndrome (MetS']","['placebo', 'colchicine 0.6 mg or placebo', 'placebo, colchicine', 'colchicine and placebo', 'colchicine', 'colchicine, 19 placebo']","['Change in S', 'Adverse events', 'metabolic improvements', 'C-reactive protein', 'metabolic health', 'homeostatic model assessment of insulin resistance', 'absolute neutrophil count', 'fasting insulin', 'obesity-associated inflammatory variables', 'changes in other metabolic variables and inflammatory markers', 'white blood cell count', 'efficacy and safety', 'glucose effectiveness', 'erythrocyte sedimentation rate', 'change in insulin sensitivity (S I  ) as estimated by insulin-modified frequently sampled intravenous glucose tolerance tests']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718493', 'cui_str': 'Colchicine 0.6 MG [Colcrys]'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance Test'}]",40.0,0.686271,"Compared with placebo, colchicine significantly reduced C-reactive protein (P <0.005), erythrocyte sedimentation rate (P <0.01), white blood cell count (P <0.005), and absolute neutrophil count (P <0.001).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Ginikanwa I', 'Initials': 'GI', 'LastName': 'Onyekaba', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Shahzaib M', 'Initials': 'SM', 'LastName': 'Khan', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Energy Metabolism Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes, Digestive and Kidney Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Broadney', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13702']
566,31007049,Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience.,"AIMS


To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods.
METHODS


Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods.
RESULTS


In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
CONCLUSION


Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.",2019,"Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505).","['and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes', 'Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements', '2423 participants were randomized: 1920 from electronic health record (mean age of 60\u2009years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9\u2009years, 58% women, 61% White']",['vitamin D'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",[],2423.0,0.631977,"Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505).","[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': '1 MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Sheehan', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Vickery', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Myrlene A', 'Initials': 'MA', 'LastName': 'Staten', 'Affiliation': '4 KGS for The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': '5 Kaiser Permanente Center for Health Research NW, Portland, OR, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Phillips', 'Affiliation': '6 Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Irwin G', 'Initials': 'IG', 'LastName': 'Brodsky', 'Affiliation': '8 Maine Medical Center, Scarborough, ME, USA.'}, {'ForeName': 'Chhavi', 'Initials': 'C', 'LastName': 'Chadha', 'Affiliation': '9 HealthPartners, Minneapolis, MN, USA.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': '10 Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Miranda G', 'Initials': 'MG', 'LastName': 'Ouellette', 'Affiliation': '11 University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Desouza', 'Affiliation': '13 University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774519839062']
567,31089818,Randomized controlled trial on immunomodulatory effects of azithromycin in children with steroid-dependent nephrotic syndrome.,"BACKGROUND


Azithromycin (AZM) is a macrolide antibiotic with anti-inflammatory and immunomodulatory effects. Our aim was to compare the immunomodulatory effects of AZM combined with steroid therapy with that of steroid therapy alone in children with steroid-dependent nephrotic syndrome (SDNS).
METHODS


We enrolled 57 patients with SDNS in a multicenter randomized control trial. Patients were classified into two groups: group A (intervention group, N = 29) and group B (control group, N = 28). After achievement of remission with full-dose daily prednisone, patients in group A received AZM in conjunction with steroids which was tapered gradually, while patients in group B received steroids alone. Urine protein creatinine ratio (uPCR) and TNF-α were measured at different points of follow-up throughout the study period (5 months after achieving remission).
RESULTS


After achievement of remission by full-dose steroids, there were significant differences of TNF-α between the two groups after 1-, 3- and 5-month follow-up (p < 0.001, 0.003, and 0.001, respectively). Also, there was significant difference of TNF-α in both intervention and control groups after exclusion of the relapsed cases at 3- and 5-month follow-up (, p = 0.031 and p = 0.003, respectively). There was significant difference between both groups after 5-month follow-up as regards the number of relapsed patients (group A = 4, group B = 11, p = 0.015).
CONCLUSION


AZM was capable of reducing serum TNF-α which is one of the inflammatory cytokines implicated in the pathogenesis of NS.",2019,AZM was capable of reducing serum TNF-α which is one of the inflammatory cytokines implicated in the pathogenesis of NS.,"['children with steroid-dependent nephrotic syndrome', 'children with steroid-dependent nephrotic syndrome (SDNS', '57 patients with SDNS']","['azithromycin', 'AZM combined with steroid therapy', 'Azithromycin (AZM', 'steroid therapy alone', 'prednisone', 'steroids alone', 'AZM']","['TNF-α', 'Urine protein creatinine ratio (uPCR) and TNF-α']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",57.0,0.100157,AZM was capable of reducing serum TNF-α which is one of the inflammatory cytokines implicated in the pathogenesis of NS.,"[{'ForeName': 'Happy', 'Initials': 'H', 'LastName': 'Sawires', 'Affiliation': 'Pediatric Nephrology Center, Cairo University, Cairo, Egypt. happy7_kd@yahoo.com.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Abdelaziz', 'Affiliation': 'Pediatric Nephrology Center, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba Mostafa', 'Initials': 'HM', 'LastName': 'Ahmed', 'Affiliation': 'Pediatric Nephrology Department, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Botrous', 'Affiliation': 'Pediatric Nephrology Department, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Agban', 'Affiliation': 'Microbiology Department, Assiut University, Assiut, Egypt.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-019-04251-5']
568,30837195,A randomized study of botulinum toxin versus botulinum toxin plus physical therapy for treatment of cervical dystonia.,"BACKGROUND


Physical therapy (PT) for cervical dystonia is not well studied, and the underlying physiological effects are not known.
METHODS


We enrolled 26 subjects comprising of 16 cervical dystonia and 10 healthy controls for normative physiological data. We randomized cervical dystonia patients who reported suboptimal benefits on botulinum toxin (BoNT) injections to BoNT alone (BoNT arm) or BoNT plus PT (PT-BoNT arm). PT-BoNT arm received manual PT on the injection day followed by six weeks of home-exercise program. Home-exercise program comprised of stretching, range-of-motion and isometric exercises. The primary outcome was change from baseline in Toronto Western spasmodic torticollis rating scale (TWSTRS) that was recorded six weeks after exercise program. TWSTRS was video evaluated by blinded raters. We probed sensorimotor plasticity with transcranial magnetic stimulation (TMS) using a paired associative stimulation (PAS) paradigm.
RESULTS


TWSTRS score improved (severity 31%, p = 0.002; pain 28%, p = 0.01) and PAS plasticity decreased (p = 0.01) in PT-BoNT arm compared to BoNT arm. PAS values for PT-BoNT arm were found to approach values of healthy control values. Change in PAS measure correlated significantly with TWSTRS change (severity, r = 0.56, p = 0.04; pain, r = 0.61, p = 0.03. TWSTRS disability score only approached significance (p = 0.14) when comparing the two treatment arms.
CONCLUSION


PT is a potential adjunct in patients with cervical dystonia who report suboptimal benefits with BoNT therapy. PT related benefits in cervical dystonia are likely mediated through modulation of sensorimotor plasticity.",2019,"RESULTS


TWSTRS score improved (severity 31%, p = 0.002; pain 28%, p = 0.01) and PAS plasticity decreased (p = 0.01) in PT-BoNT arm compared to BoNT arm.","['26 subjects comprising of 16 cervical dystonia and 10 healthy controls for normative physiological data', 'patients with cervical dystonia', 'cervical dystonia', 'cervical dystonia patients who reported suboptimal benefits on']","['manual PT', 'botulinum toxin', 'Physical therapy (PT', 'transcranial magnetic stimulation (TMS) using a paired associative stimulation (PAS) paradigm', 'botulinum toxin plus physical therapy', 'Home-exercise program comprised of stretching, range-of-motion and isometric exercises', 'botulinum toxin (BoNT) injections to BoNT alone (BoNT arm) or BoNT plus PT']","['TWSTRS disability score', 'change from baseline in Toronto Western spasmodic torticollis rating scale (TWSTRS', 'PAS plasticity', 'PAS values', 'Change in PAS']","[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",26.0,0.129308,"RESULTS


TWSTRS score improved (severity 31%, p = 0.002; pain 28%, p = 0.01) and PAS plasticity decreased (p = 0.01) in PT-BoNT arm compared to BoNT arm.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rundle-Gonzalez', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Shankar J', 'Initials': 'SJ', 'LastName': 'Kulkarni', 'Affiliation': 'Shands Rehabilitation Service, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martinez-Ramirez', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Almeida', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Wagle Shukla', 'Affiliation': 'Center for Movement Disorders and Neurorestoration, Department of Neurology, University of Florida, Gainesville, FL, USA. Electronic address: Aparna.shukla@neurology.ufl.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.02.035']
569,31405867,"Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Omadacycline on QT/QTc Intervals in Healthy Subjects.","Omadacycline, an aminomethylcycline, is an antibiotic that is approved in the United States for once-daily intravenous (i.v.) and oral use for treatment of adults with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. In this thorough QT study, the effects of a therapeutic (100 mg i.v.) dose and a supratherapeutic (300 mg i.v.) dose of omadacycline on the electrocardiogram were studied, with placebo and moxifloxacin as negative and positive controls. Omadacycline at these doses had no effect on the QTc interval. The largest mean placebo-corrected change-from-baseline QTcS (ΔQTcS) were 1.7 ms (90% confidence interval [CI], 0.06 to 3.30) and 2.6 ms (90% CI, 0.55 to 4.67), observed at 20 min and 2 h after the start of the infusion of 100 mg and 300 mg, respectively. Assay sensitivity was demonstrated with moxifloxacin, which caused clear prolongation of QTcS, with the largest mean placebo-corrected ΔQTcS of 9.8 ms at 1.5 and 2 h. With a linear exposure-response model, the estimated slope of the concentration-change-from-baseline QTcF (ΔQTcF) relationship was very shallow: 0.0007 ms per ng/ml (90% CI, 0.0000 to 0.0014). The possibility of an effect on placebo-corrected ΔQTcS exceeding 10 ms can be excluded at omadacycline concentrations in plasma of up to ∼8 μg/ml. Omadacycline had no effect on cardiac conduction (PR and QRS intervals) but caused an increase in heart rate of 16.8 beats per min at 35 min after the 100-mg dose and 21.6 beats per min at 50 min after the 300-mg dose.",2019,"Omadacycline had no effect on cardiac conduction (PR and QRS intervals), but caused an increase in heart rate of 16.8 beats per minute at 35 min after the 100-mg dose and 21.6 beats per minute at 50 min after the 300-mg dose.","['adults with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia', 'Healthy Subjects']","['Omadacycline', 'placebo-corrected ΔQTcS', 'supratherapeutic', 'placebo and moxifloxacin', 'omadacycline', 'moxifloxacin', 'Omadacycline, an aminomethylcycline', 'Placebo']","['QTc interval', 'cardiac conduction (PR and QRS intervals', 'Assay sensitivity', 'heart rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0004626', 'cui_str': 'Pneumonia, Bacterial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.295641,"Omadacycline had no effect on cardiac conduction (PR and QRS intervals), but caused an increase in heart rate of 16.8 beats per minute at 35 min after the 100-mg dose and 21.6 beats per minute at 50 min after the 300-mg dose.","[{'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Rochester, New York, USA borje.darpo@ert.com.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, Rochester, New York, USA.'}, {'ForeName': 'S Ken', 'Initials': 'SK', 'LastName': 'Tanaka', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Tzanis', 'Affiliation': 'Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00922-19']
570,31648072,"Acute differences in pulse wave velocity, augmentation index, and central pulse pressure following controlled exposures to cookstove air pollution in the Subclinical Tests of Volunteers Exposed to Smoke (SToVES) study.","Household air pollution emitted from solid-fuel cookstoves used for domestic cooking is a leading risk factor for morbidity and premature mortality globally. There have been attempts to design and distribute lower emission cookstoves, yet it is unclear if they meaningfully improve health. Using a crossover design, we assessed differences in central aortic hemodynamics and arterial stiffness following controlled exposures to air pollution emitted from five different cookstove technologies compared to a filtered air control. Forty-eight young, healthy participants were assigned to six 2-h controlled treatments of pollution from five different cookstoves and a filtered air control. Each treatment had a target concentration for fine particulate matter: filtered air control = 0 μg/m 3 , liquefied petroleum gas = 10 μg/m 3 , gasifier = 35 μg/m 3 , fan rocket = 100 μg/m 3 , rocket elbow = 250 μg/m 3 , three stone fire = 500 μg/m 3 . Pulse wave velocity (PWV), central augmentation index (AIx), and central pulse pressure (CPP) were measured before and at three time points after each treatment (0, 3, and 24 h). Linear mixed models were used to assess differences in the outcomes for each cookstove treatment compared to control. PWV and CPP were marginally higher 24 h after all cookstove treatments compared to control. For example, PWV was 0.15 m/s higher (95% confidence interval: -0.02, 0.31) and CPP was 0.6 mmHg higher (95% confidence interval: -0.8, 2.1) 24 h after the three stone fire treatment compared to control. The magnitude of the differences compared to control was similar across all cookstove treatments. PWV and CPP had no consistent trends at the other post-treatment time points (0 and 3 h). No consistent trends were observed for AIx at any post-treatment time point. Our findings suggest higher levels of PWV and CPP within 24 h after 2-h controlled treatments of pollution from five different cookstove technologies. The similar magnitude of the differences following each cookstove treatment compared to control may indicate that acute exposures from even the cleanest cookstove technologies can adversely impact these subclinical markers of cardiovascular health, although differences were small and may not be clinically meaningful.",2020,"For example, PWV was 0.15 m/s higher (95% confidence interval: -0.02, 0.31) and CPP was 0.6 mmHg higher (95% confidence interval: -0.8, 2.1) 24 h after the three stone fire treatment compared to control.","['\u202f500\u202fμg', '\u202f100\u202fμg', 'Forty-eight young, healthy participants']","['liquefied petroleum gas\u202f=\u202f10\u202fμg/m 3 , gasifier\u202f=\u202f35\u202fμg/m 3 , fan rocket']","['CPP', 'PWV and CPP', 'central aortic hemodynamics and arterial stiffness', 'Pulse wave velocity (PWV), central augmentation index (AIx), and central pulse pressure (CPP', 'pulse wave velocity, augmentation index, and central pulse pressure']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}]","[{'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",48.0,0.0546158,"For example, PWV was 0.15 m/s higher (95% confidence interval: -0.02, 0.31) and CPP was 0.6 mmHg higher (95% confidence interval: -0.8, 2.1) 24 h after the three stone fire treatment compared to control.","[{'ForeName': 'Ethan S', 'Initials': 'ES', 'LastName': 'Walker', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: ethan.walker@colostate.edu.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Fedak', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: kristen.fedak@colostate.edu.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: n.good@colostate.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA. Electronic address: john.balmes@ucsf.edu.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. Electronic address: robdbrok@med.umich.edu.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: maggie.clark@colostate.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole-Hunter', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: t.cole-hunter@qut.edu.au.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Dinenno', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA. Electronic address: frank.dinenno@colostate.edu.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, United States Environmental Protection Agency, Research Triangle Park, NC, USA. Electronic address: devlin.robert@epa.gov.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': ""L'Orange"", 'Affiliation': 'Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA. Electronic address: christian.lorange@colostate.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Luckasen', 'Affiliation': 'Heart Center of the Rockies, Fort Collins, CO, USA. Electronic address: gary.luckasen@uchealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehaffy', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA. Electronic address: john.mehaffy@colostate.edu.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: rhiannon.shelton@ucdenver.edu.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, CO, USA. Electronic address: ander.wilson@colostate.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Volckens', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA. Electronic address: john.volckens@colostate.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA. Electronic address: jennifer.peel@colostate.edu.'}]",Environmental research,['10.1016/j.envres.2019.108831']
571,31864166,"Inhibitory-control training for cocaine use disorder and contingency management for clinic attendance: A randomized pilot study of feasibility, acceptability and initial efficacy.","BACKGROUND


Cocaine abusers have impaired inhibitory Cocaine use is associated with impaired inhibitory control. This study determined the feasibility, acceptability, and initial efficacy of inhibitory-control training to cocaine or neutral images in cocaine use disorder patients.
METHODS


Participants were randomly assigned to inhibitory-control training to cocaine (N = 20) or neutral (N = 20) images. Feasibility was assessed by percent of patients eligible for participation after a behavioral qualification session, time-to-target enrollment, percent of clinic visits attended, percent of participants who completed 80 % or more training sessions, and percent of follow-up visits attended. Acceptability was determined using a Treatment Acceptability Questionnaire. Initial efficacy was determined during training and a follow-up phase with urine samples tested qualitatively and quantitatively for cocaine. Participants in both conditions received monetary incentives delivered on an escalating schedule for clinic attendance.
RESULTS


The groups were well matched and no differences on demographic or substance use variables were observed. Attendance was stable during the treatment period with high overall attendance in both groups (average sessions attended: cocaine image group = 97 %; neutral image group = 90 %). No group differences were observed in the percentage of follow-up sessions attended (95 % for the cocaine-image group; 88 % of neutral-image group). Ratings on the Treatment Acceptability Questionnaire were high (i.e., mean scores ≥ 80 for all items rated on 101-unit visual analog scales). Participants in the cocaine- and neutral-image conditions did not differ significantly in terms of cocaine use during the training nor follow-up phase. Inhibitory-control training improved stop signal performance but not delay discounting.
CONCLUSION


The procedures were feasible and acceptable. Inhibitory-control training to cocaine images did not reduce cocaine use relative to the neutral image training condition. The inability to detect significant differences in cocaine use across the groups is not surprising given the small sample size. More research is needed to determine the utility of inhibitory-control training for cocaine use disorder. Future trials should determine whether inhibitory-control training to cocaine images augments the efficacy of other behavioral interventions.",2020,No group differences were observed in the percentage of follow-up sessions attended (95 % for the cocaine-image group; 88 % of neutral-image group).,"['clinic attendance', 'patients eligible for participation after a behavioral qualification session, time-to-target enrollment, percent of clinic visits attended, percent of participants who completed 80 % or more training sessions, and percent of follow-up visits attended', 'cocaine use disorder patients', 'Participants']","['inhibitory-control training to cocaine (N\u202f=\u202f20) or neutral (N\u202f=\u202f20) images', 'inhibitory-control training to cocaine', 'Inhibitory-control training']","['Treatment Acceptability Questionnaire', 'Initial efficacy', 'Acceptability', 'stop signal performance', 'Attendance']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",,0.0235554,No group differences were observed in the percentage of follow-up sessions attended (95 % for the cocaine-image group; 88 % of neutral-image group).,"[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536, USA; Department of Psychology, University of Kentucky, College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506, USA; Department of Psychiatry, University of Kentucky, College of Medicine, 3470 Blazer Parkway, Lexington, KY 40509, USA. Electronic address: crush2@email.uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychology, University of Kentucky, College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Pike', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536, USA.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Studts', 'Affiliation': 'Department of Health, Behavior & Society, College of Public Health, University of Kentucky, Lexington, KY USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536, USA; Department of Psychology, University of Kentucky, College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506, USA; Department of Psychiatry, University of Kentucky, College of Medicine, 3470 Blazer Parkway, Lexington, KY 40509, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107803']
572,30519803,Predictors of Mental Health Recovery in Homeless Adults with Mental Illness.,"For people with mental illness, experiences of homelessness can complicate mental health recovery processes. This study used longitudinal data from a randomized controlled trial of housing first (HF) to examine predictors of recovery among homeless people with mental illness. Findings showed that health and community predictors were most strongly associated with mental health recovery. Receipt of HF did not have any effect on changes in recovery scores at follow-up. Overall, the findings suggest that interventions aimed at preventing chronic homelessness, strengthening social networks and community involvement, and providing case management services will facilitate mental health recovery.",2019,Receipt of HF did not have any effect on changes in recovery scores at follow-up.,"['homeless people with mental illness', 'Homeless Adults with Mental Illness']",['housing first (HF'],"['recovery scores', 'mental health recovery']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}]",,0.210734,Receipt of HF did not have any effect on changes in recovery scores at follow-up.,"[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Kerman', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, K1N 6N5, Canada. nkerm094@uottawa.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sylvestre', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, K1N 6N5, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, K1N 6N5, Canada.'}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': 'Institute of Urban Studies, Univerity of Winnipeg, Winnipeg, MB, Canada.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Schütz', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}]",Community mental health journal,['10.1007/s10597-018-0356-3']
573,31332045,Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD.,"The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use. This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment. Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT). Other outcomes included quality of life (QoL) measures and safety. Sixty patients were randomized; ITT included 53 patients (SoC+ECP: 29; SoC: 24). Week 28 ORR was 74.1% (SoC+ECP) and 60.9% (SoC). Investigator-assessed ORR was 56.0% (SoC+ECP) and 66.7% (SoC). Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients. Most frequent treatment-emergent adverse events (TEAEs) in SoC+ECP patients were hypertension (31.0%), cough (20.7%), dyspnea (17.2%), and fatigue (17.2%). Seventeen patients (SoC+ECP: 8; SoC: 9) experienced 35 serious adverse events (SAEs). No TEAEs or SAEs were considered related to the ECP instrument or methoxsalen. The encouraging short-term results of this study could inform the design of subsequent studies. This trial was registered at www.clinicaltrials.gov as #NCT01380535.",2019,Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients.,"['Sixty patients were randomized; ITT included 53 patients (SoC+ECP: 29; SoC: 24', 'patients with moderate to severe cGVHD', 'Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD', '2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment']","['SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus', 'extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP', 'ECP', 'ECP with methoxsalen']","['overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT', 'Investigator-assessed ORR', 'quality of life (QoL) measures and safety', 'QoL', 'ORR', 'cough', 'dyspnea', '35 serious adverse events (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0206373', 'cui_str': 'Photochemotherapy, Extracorporeal'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0025684', 'cui_str': 'Methoxsalen'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",53.0,0.115585,Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients.,"[{'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Jagasia', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Stem Cell Transplantation Clinic I for Internal Medicine, University of Cologne, Köln, Germany.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': 'APHP Hospital St. Louis, University Paris 7, Paris, France.'}, {'ForeName': 'Francis Ayuketang', 'Initials': 'FA', 'LastName': 'Ayuk', 'Affiliation': 'Department of Stem Cell Transplantation, Universitäetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Tischer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Munich, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Donato', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Bátai', 'Affiliation': 'Unified St. Istvan and St. Laszio Hospital, Budapest, Hungary.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sheau-Chiann', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chin', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ; and.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Boodée', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ; and.'}, {'ForeName': 'Ghaith', 'Initials': 'G', 'LastName': 'Mitri', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ; and.'}, {'ForeName': 'Hildegard T', 'Initials': 'HT', 'LastName': 'Greinix', 'Affiliation': 'Division of Haematology, Medical University of Graz, Graz, Austria.'}]",Blood advances,['10.1182/bloodadvances.2019000145']
574,32150258,Pain and Psychological Outcomes Among Iraq and Afghanistan Veterans with Chronic Pain and PTSD: ESCAPE Trial Longitudinal Results.,"OBJECTIVE


To compare pain and psychological outcomes in veterans with chronic musculoskeletal pain and comorbid post-traumatic stress disorder (PTSD) or pain alone and to determine if veterans with comorbidity respond differently to a stepped-care intervention than those with pain alone.
DESIGN


Secondary analysis of data from the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial.
SETTING


Six Veterans Health Affairs clinics.
SUBJECTS


Iraq and Afghanistan veterans (N = 222) with chronic musculoskeletal pain.
METHODS


Longitudinal analysis of veterans with chronic musculoskeletal pain and PTSD or pain alone and available baseline and nine-month trial data. Participants randomized to either usual care or a stepped-care intervention were analyzed. The pain-PTSD comorbidity group screened positive for PTSD and had a PTSD Checklist-Civilian score ≥41 at baseline.
RESULTS


T tests demonstrated statistically significant differences and worse outcomes on pain severity, pain cognitions, and psychological outcomes in veterans with comorbid pain and PTSD compared with those with pain alone. Analysis of covariance (ANCOVA) modeling change scores from baseline to nine months indicated no statistically significant differences, controlling for PTSD, on pain severity, pain centrality, or pain self-efficacy. Significant differences emerged for pain catastrophizing (t = 3.10, P < 0.01), depression (t = 3.39, P < 0.001), and anxiety (t = 3.80, P < 0.001). The interaction between PTSD and the stepped-care intervention was not significant.
CONCLUSIONS


Veterans with the pain-PTSD comorbidity demonstrated worse pain and psychological outcomes than those with chronic pain alone. These findings indicate a more intense chronic pain experience for veterans when PTSD co-occurs with pain. PTSD did not lead to a differential response to a stepped-care intervention.",2020,"Significant differences emerged for pain catastrophizing (t = 3.10, P < 0.01), depression (t = 3.39, P < 0.001), and anxiety (t = 3.80, P < 0.001).","['Six Veterans Health Affairs clinics', 'veterans with chronic musculoskeletal pain and comorbid post-traumatic stress disorder (PTSD) or', 'Iraq and Afghanistan veterans (N\u2009=\u2009222) with chronic musculoskeletal pain', 'veterans with chronic musculoskeletal pain and PTSD or pain alone and available baseline and nine-month trial data', 'Iraq and Afghanistan Veterans with Chronic Pain and PTSD', 'veterans with comorbidity respond differently to a stepped-care intervention than those with pain alone', 'Veterans with the pain-PTSD comorbidity']","['usual care or a stepped-care intervention', 'pain alone']","['pain catastrophizing', 'anxiety', 'Pain and Psychological Outcomes', 'pain severity, pain cognitions, and psychological outcomes', 'pain severity, pain centrality, or pain self-efficacy', 'pain and psychological outcomes', 'depression']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",222.0,0.0623471,"Significant differences emerged for pain catastrophizing (t = 3.10, P < 0.01), depression (t = 3.39, P < 0.001), and anxiety (t = 3.80, P < 0.001).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service, Indianapolis, Indiana.'}, {'ForeName': 'Samantha D', 'Initials': 'SD', 'LastName': 'Outcalt', 'Affiliation': 'Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service, Indianapolis, Indiana.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ang', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Zhangsheng', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Center of Statistics Research, Research Department, School of Statistics, Shanghai Jiaotong University, Shanghai, China.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa007']
575,31689641,A community pharmacy-led intervention for opioid medication misuse: A small-scale randomized clinical trial.,"BACKGROUND


Stemming the opioid epidemic requires testing novel interventions. Toward this goal, feasibility and acceptability of a Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention was examined along with its impact on medication misuse and concomitant health conditions.
METHODS


We conducted a two-group randomized trial in 2 community pharmacies. We screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index. Participants were assigned to standard medication counseling (SMC) or SMC + BMI-MTM (referred to as BMI-MTM herein). BMI-MTM consists of a pharmacist-led medication counseling/brief motivational session and 8-weekly patient navigation sessions. Assessments were at baseline, 2-, and 3-months. Primary outcomes included feasibility, acceptability, and mitigation of opioid medication misuse. Secondary outcomes included pain and depression. Outcomes were analyzed with descriptive and multivariable statistics (intent-to-treat [ITT] and adjusted for number of sessions completed [NUMSESS]).
RESULTS


Thirty-two participants provided informed consent (74.4% consent rate; SMC n = 17, BMI-MTM n = 15; 3-month assessment retention ≥93%). Feasibility was demonstrated by all BMI-MTM recipients completing the pharmacist session and an average of 7 navigation sessions. BMI-MTM recipients indicated ≥4.2 (5 maximum) level of satisfaction with the pharmacist-led session, and 92.4% were satisfied with navigation sessions. Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS


AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = 14.0, 95% CI = 3.28, 24.8, p = 0.01), and depression (ITT: B= -0.44; 95% CI=-0.65, -0.22; p < 0.001.
NUMSESS


B= -0.64; 95% CI=-0.82, -0.46; p < 0.001).
CONCLUSIONS


BMI-MTM is a feasible misuse intervention associated with superior satisfaction and outcomes than SMC. Future research should test BMI-MTM in a large-scale, fully-powered trial.",2019,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS


AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","['screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index', '2 community pharmacies']","['standard medication counseling (SMC) or SMC\u202f+\u202fBMI-MTM', 'Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention']","['number of sessions completed [NUMSESS', 'pain and depression', 'feasibility, acceptability, and mitigation of opioid medication misuse', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",32.0,0.100783,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS


AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Cochran', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA; University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: jerry.cochran@hsc.utah.edu.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: QIC31@pitt.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Field', 'Affiliation': 'University of Texas, El Paso, Department of Psychology, Psychology Building, Room 112 500 W University, El Paso, Texas, 79902, USA. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Seybert', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmacy and Therapeutics, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: seyberta@pitt.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hruschak', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: VJH6@pitt.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Falk Pharmacy, UPMC 3601 Fifth Ave, Pittsburgh, PA 15213, USA. Electronic address: jabera@upmc.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA. Electronic address: Adam.Gordon@hsc.utah.edu.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tarter', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmaceutical Sciences, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: tarter@pitt.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107570']
576,31704382,Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.,"OBJECTIVES


To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory.
METHODS


Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254).
RESULTS


Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes.
CONCLUSIONS


Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.",2019,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","['535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of', 'patients with OUD']","['BUP-NX', 'XR-NTX', 'buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'naltrexone and buprenorphine-naloxone']","['BUP-NX', 'XR-NTX']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],535.0,0.0141898,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol and Substance Use Studies, Graduate School of Applied and Professional Psychology, Rutgers University, New Brunswick, United States. Electronic address: lesia.ruglass@rutgers.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Biostatistics Department, Mailman School of Public Health, Columbia University, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, United States.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School and McLean Hospital, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107649']
577,30788599,Rehabilitation following lumbar fusion surgery (REFS) a randomised controlled feasibility study.,"PURPOSE


Following lumbar fusion surgery (LFS), 40% of patients are unsure/dissatisfied with their outcome. A prospective, single-centre, randomised, controlled trial was conducted to evaluate the feasibility (including clinical and economic impact) of a theoretically informed rehabilitation programme following LFS (REFS).
METHODS


REFS was informed by an explicit theoretical framework and consisted of 10 consecutive weekly group rehabilitation sessions (education, low-tech cardiovascular, limb and spine strengthening exercises, and peer support). Participants were randomised to REFS or 'usual care.' Primary feasibility outcomes included recruitment and engagement. Secondary outcomes, collected preoperatively and 3, 6, and 12  months postoperatively, comprised the Oswestry disability index, European Quality of Life 5 dimensions score, pain self-efficacy questionnaire, hospital anxiety and depression scale and the aggregated functional performance time. Economic impact was evaluated with the Client Services Receipt Inventory.
RESULTS


Fifty-two of 58 eligible participants were recruited, and engagement with REFS was > 95%. REFS participants achieved a clinically meaningful reduction in unadjusted mean short-term disability (- 13.27 ± 13.46), which was not observed in the 'usual care' group (- 2.42 ± 12.33). This was maintained in the longer term (- 14.72% ± 13.34 vs - 7.57 ± 13.91). Multilevel regression analyses, adjusted for body mass index, baseline depression, and smoking status reported a statistically significant short-term improvement in disability (p = 0.014) and pain self-efficacy (p = 0.007). REFS costs £275 per participant.
CONCLUSIONS


Results suggest that REFS is feasible and potentially affordable for delivery in the National Health Service. It is associated with a clinically meaningful impact. A multicentre randomised controlled study to further elucidate these results is warranted. These slides can be retrieved under Electronic Supplementary Material.",2019,"REFS participants achieved a clinically meaningful reduction in unadjusted mean short-term disability (- 13.27 ± 13.46), which was not observed in the 'usual care' group (- 2.42 ± 12.33).",['Fifty-two of 58 eligible participants'],"['rehabilitation sessions (education, low-tech cardiovascular, limb and spine strengthening exercises, and peer support', ""REFS or 'usual care"", 'REFS', 'lumbar fusion surgery (REFS', 'lumbar fusion surgery (LFS']","['Oswestry disability index, European Quality of Life 5 dimensions score, pain self-efficacy questionnaire, hospital anxiety and depression scale and the aggregated functional performance time', 'pain self-efficacy', 'disability']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4075347', 'cui_str': 'PSEQ - Pain Self-efficacy Questionnaire'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C3853978'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.131735,"REFS participants achieved a clinically meaningful reduction in unadjusted mean short-term disability (- 13.27 ± 13.46), which was not observed in the 'usual care' group (- 2.42 ± 12.33).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Greenwood', 'Affiliation': 'Victor Horsley Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, Internal Box 8, Queen Square, London, WC1 3BG, UK. james.greenwood4@nhs.net.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McGregor', 'Affiliation': 'Biodynamics Lab, Charing Cross Hospital, Imperial College London, Charing Cross Campus, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Social Care Sciences, St Georges University of London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': 'Faculty of Health and Social Care Sciences, St Georges University of London, London, UK.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05913-6']
578,31866256,Pairing Feeding Content With a Nutrition Education Curriculum: A Comparison of Online and In-Class Delivery.,"OBJECTIVE


To develop a childhood obesity prevention program, Food, Feeding and Your Family (FFYF), which encourages eating self-regulation in young children. This article describes the research methods for FFYF. Activities that will be used to guide the development of the program are illustrated in a logic model.
DESIGN


A randomized control trial will be conducted with participant groups randomized into 1 of 3 conditions: (1) in-class delivery of feeding content and nutrition education, (2) online delivery of feeding content and in-class delivery of nutrition education, and (3) nutrition education only. Assessments will be collected at baseline, program completion, and 6 and 12 months after completion of the program.
SETTING


Study will be conducted through the Expanded Food and Nutrition Education Program in Colorado and Washington State.
PARTICIPANTS


Parents with 2- to 8-year-old children will be recruited from affiliated community agencies, 540 participants across both states.
INTERVENTIONS


FFYF derives content from an empirically validated parental feeding program, Strategies for Effective Eating Development, and will be administered with Eating Smart • Being Active, an evidence-based, nutrition education curriculum.
MAIN OUTCOME MEASURES


Parents will report on feeding practices, child eating behaviors, feeding styles, and acculturation.
ANALYSIS


Because of the nested nature of the data, multilevel analyses will be used: time points, within parents, and within groups.",2020,"OBJECTIVE


To develop a childhood obesity prevention program, Food, Feeding and Your Family (FFYF), which encourages eating self-regulation in young children.","['Parents with 2- to 8-year-old children will be recruited from affiliated community agencies, 540 participants across both states', 'young children']","['Pairing Feeding Content With a Nutrition Education Curriculum', 'class delivery of feeding content and nutrition education, (2) online delivery of feeding content and in-class delivery of nutrition education, and (3) nutrition education only']",[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",[],540.0,0.049158,"OBJECTIVE


To develop a childhood obesity prevention program, Food, Feeding and Your Family (FFYF), which encourages eating self-regulation in young children.","[{'ForeName': 'Sheryl O', 'Initials': 'SO', 'LastName': 'Hughes', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service, Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX. Electronic address: shughes@bcm.edu.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Power', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Baker', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO.'}, {'ForeName': 'Karen V', 'Initials': 'KV', 'LastName': 'Barale', 'Affiliation': 'Washington State University Extension, Pierce County, Tacoma, WA.'}, {'ForeName': 'Jane D', 'Initials': 'JD', 'LastName': 'Lanigan', 'Affiliation': 'Department of Human Development, Washington State University, Vancouver, WA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Washington State University Extension, Seattle, WA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Silva Garcia', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'M Catalina', 'Initials': 'MC', 'LastName': 'Aragon', 'Affiliation': 'Washington State University Extension, Pierce County, Tacoma, WA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Johnston', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, TX.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Micheli', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service, Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.11.004']
579,31345971,Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.,"INTRODUCTION


In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients' health behaviours and HBCPs' work satisfaction.
METHODS AND ANALYSIS


This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs' programme; (2) HBCPs' programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs' programme. Under each hospital, administrative areas implementing the HBCPs' programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs' programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03376607; Pre-results.",2019,"Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy.","['of diabetes in primary healthcare in Rwanda (D²Rwanda', 'Eligible patients from each area will receive the same intervention']","['Community- and mHealth-based integrated management', ""HBCPs' programme; (2) HBCPs' programme + mobile\u2009health application) and usual care (control""]","['diabetes mellitus prevalence', 'medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy', 'changes in glycated haemoglobin']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0035978', 'cui_str': 'Ruanda'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}]",,0.12939,"Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy.","[{'ForeName': 'Charilaos', 'Initials': 'C', 'LastName': 'Lygidakis', 'Affiliation': 'Institute for Health and Behaviour - Research Unit INSIDE, Universite du Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Uwizihiwe', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Butare, Rwanda.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'Centre for Global Health, Department of Public Health, Aarhus Universitet, Aarhus, Denmark.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Bia', 'Affiliation': 'Labor Market, Luxembourg Institute of Socio-Economic Research, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Condo', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Butare, Rwanda.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Institute for Health and Behaviour - Research Unit INSIDE, Universite du Luxembourg, Esch-sur-Alzette, Luxembourg.'}]",BMJ open,['10.1136/bmjopen-2018-028427']
580,31345973,'I'm here to save my life': a qualitative study of experiences navigating a cryotherapy referral system for human papillomavirus-positive women in western Kenya.,"BACKGROUND


We sought to understand the beliefs, social norms and logistical factors that affect human papillomavirus (HPV)-positive women's uptake of cryotherapy treatment as part of a two-part cervical cancer screening strategy in rural Kenya.
METHODS


In-depth interviews within a parent cluster-randomised trial.
SETTING


Government-run county hospital in western Kenya.
PARTICIPANTS


273 of 372 (73.4%) HPV-positive women who underwent cryotherapy RESULTS: Many women feared that an HPV infection meant they would develop cancer. Almost all women reported initial fear of the treatment procedure, followed by a more positive experience than anticipated. Lacking funds for transportation to the treatment site was the most common barrier. Women felt that decentralised treatment would be the most important facilitator of greater access. Spousal encouragement and financial support were key facilitators of treatment access, however many women felt that other husbands in the community would not be supportive. Women described successfully acquiring treatment as empowering, and almost all would recommend seeking cryotherapy to other women who test HPV-positive. Most felt eager to share their own experiences with others to encourage treatment.
CONCLUSIONS


The main facilitators of treatment access were understanding of the health risks and sense of empowerment. A decentralised treatment model or transportation support may facilitate access, along with improved health messaging about HPV infection, cancer and the treatment process. Focusing on women's personal feelings of empowerment may further improve uptake and satisfaction. These data will be used to design a strategy to improve linkage to treatment.
TRIAL REGISTRATION


NCT02124252.",2019,"A decentralised treatment model or transportation support may facilitate access, along with improved health messaging about HPV infection, cancer and the treatment process.","['Government-run county hospital in western Kenya', ""human papillomavirus (HPV)-positive women's uptake of cryotherapy treatment as part of a two-part cervical cancer screening strategy in rural Kenya"", 'In-depth interviews within a parent cluster-randomised trial', 'human papillomavirus-positive women in western Kenya', '273 of 372 (73.4%) HPV-positive women who underwent cryotherapy RESULTS']",['experiences navigating a cryotherapy referral system'],['health risks and sense of empowerment'],"[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",,0.0768895,"A decentralised treatment model or transportation support may facilitate access, along with improved health messaging about HPV infection, cancer and the treatment process.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Huchko', 'Affiliation': 'Center for Global Reproductive Health, Duke Global Health Institute, Durham, North Carolina, USA megan.huchko@duke.edu.'}, {'ForeName': 'Konyin', 'Initials': 'K', 'LastName': 'Adewumi', 'Affiliation': 'Center for Global Reproductive Health, Duke Global Health Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oketch', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Saduma', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}]",BMJ open,['10.1136/bmjopen-2018-028669']
581,31366649,Effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a protocol for a feasibility randomised controlled trial (the Otago MASTER trial).,"INTRODUCTION


Exercise therapy is the treatment of choice for the management of patients with shoulder subacromial pain. However, we do not know whether a tailored rehabilitation programme is more effective than a standardised strengthening programme. The aim of this feasibility trial is to assess: (1) participant recruitment rate, (2) the proportion of participants enrolled from the total number screened, (3) adherence to the rehabilitation programme, (4) drop-out rates, (5) obtain estimates of adverse reactions to treatment, (6) obtain estimates of intervention effects in order to inform the sample size of the fully-powered randomised controlled trial, (7) conduct a preliminary cost-effectiveness analysis of the standardised strengthening and the tailored rehabilitation interventions.
METHODS


The MAnagement of Subacromial disorders of The shouldER (MASTER) trial, is a two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. Participants will be randomly allocated into one of the interventions group: tailored or standardised rehabilitation. To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. To determine whether it is feasible to conduct the full trial, we will consider 75% CI as the probability threshold at 3-month follow-up.
ETHICS AND DISSEMINATION


This study was approved by the University of Otago Ethics Committee (Ref: H17/080). Findings from this study will be presented at national and international conferences, and will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ANZCTR: 12617001405303.",2019,"To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%.","['patients with shoulder pain', 'patients with shoulder subacromial pain']","['tailored rehabilitation versus standard strengthening programme', 'Exercise therapy', 'standardised strengthening and the tailored rehabilitation interventions', 'interventions group: tailored or standardised rehabilitation']",['pain and shoulder-related disability scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.196201,"To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%.","[{'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Jafarian Tangrood', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2018-028261']
582,31371167,A qualitative study of patients' experience of recovery after a distal femoral fracture.,"PURPOSE


This qualitative study was conducted as part of a feasibility study for TrAFFix, (ISRCTN92089567), a randomised controlled trial that will compare two surgical interventions used to fix distal femoral fractures. Our aim was to understand patients' experiences of treatment and the early phase of recovery after a distal femoral fracture. While, much is known about the experience of recovery from hip fracture, little is known about whether patients with other lower limb fragility fractures experience the same concerns and challenges.
MATERIALS AND METHODS


Semi-structured interviews were conducted with 11 patients participating in TrAFFix or their relative. Interviews were conducted face to face or by telephone. With agreement from participants, interviews were audio recorded and transcribed. Transcripts were analysed inductively using thematic analysis. As part of the user involvement for TrAFFix, we held a focus group with PPI representatives who had experience or knowledge of lower limb fractures, to learn about factors that might influence patients' recovery after a fragility facture. Data from the focus group relevant to themes from our thematic analysis are also presented.
RESULTS


Three themes were identified within patients' accounts of their experience. Our data revealed that: i) being informed about treatment and recovery was important to patients; ii) patients muddled through and found ways to manage at home, often needing the support of others; and iii) rehabilitation was arduous for patients who received limited rehabilitative support and at times lacked confidence to follow the instructions that they were given.
CONCLUSIONS


Our findings highlight the struggle patients endure while recovering after a distal femoral fracture and the limited rehabilitative support they receive after discharge from hospital. They reinforce the need to ensure a patient feels informed about their treatment and recovery and the need for greater support for patients to manage at home and move with confidence.",2019,"As part of the user involvement for TrAFFix, we held a focus group with PPI representatives who had experience or knowledge of lower limb fractures, to learn about factors that might influence patients' recovery after a fragility facture.","['Semi-structured interviews were conducted with 11 patients participating in TrAFFix or their relative', ""patients' experience of recovery after a distal femoral fracture""]",['TrAFFix'],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}]",[],[],,0.0267554,"As part of the user involvement for TrAFFix, we held a focus group with PPI representatives who had experience or knowledge of lower limb fractures, to learn about factors that might influence patients' recovery after a fragility facture.","[{'ForeName': 'Emma Elizabeth', 'Initials': 'EE', 'LastName': 'Phelps', 'Affiliation': 'Oxford Trauma, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK. Electronic address: emma.phelps@ndorms.ox.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tutton', 'Affiliation': 'Oxford Trauma, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK; Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Oxford Trauma, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Injury,['10.1016/j.injury.2019.07.021']
583,31200648,"Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use.","BACKGROUND


Two randomized controlled trials (RCTs) were conducted to explore the utility of the Mechanical Turk (MTurk) crowdsourcing platform to conduct rapid trials evaluating online interventions for unhealthy alcohol use.
METHODS


Both trials employed a staged recruitment procedure where participants who drank in an unhealthy fashion were identified using a baseline survey and then invited to take part in a 6-month follow-up. Participants in both trials were randomized to receive one of several different online interventions or to a no intervention control condition. In study 1, the online interventions were password protected and only those who accessed the study portal were randomized to condition. In study 2, participants were directed to free-of charge interventions and asked to send a screenshot of the intervention to demonstrate that they had complied.
RESULTS


Participants reporting unhealthy alcohol use were recruited fairly rapidly. Large numbers of screeners were completed (Study 1: n = 4910; Study 2: n = 5812), found eligible (Study 1: n = 3741; Study 2: n = 4095), and randomized to condition (Study 1: n = 511; Study 2: n = 878). Fair follow-up rates were observed at 6 months for each study (Study 1: 82%; Study 2: 66%). Neither trial was able to clearly demonstrate that providing access to the online interventions lead to increased reductions in alcohol use as compared to the control group.
CONCLUSIONS


While recruitment through a crowdsourcing platform is rapid and relatively low cost, it is possible that the lack of impact of the online websites employed in these trials could be due to the source of participants rather than the lack of efficacy of the interventions.
TRIAL REGISTRATION


ClinicalTrials.gov # NCT02977026 and NCT03060135 .",2019,"Neither trial was able to clearly demonstrate that providing access to the online interventions lead to increased reductions in alcohol use as compared to the control group.
","['Participants reporting unhealthy alcohol use were recruited fairly rapidly', 'participants who drank in an unhealthy fashion', 'participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use', 'Large numbers of screeners were completed (Study 1: n\u2009=\u20094910; Study 2: n\u2009=\u20095812), found eligible (Study 1: n\u2009=\u20093741; Study 2: n\u2009=\u20094095), and randomized to condition (Study 1: n\u2009=\u2009511; Study 2: n\u2009=\u2009878']",['several different online interventions or to a no intervention control condition'],[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],,0.14556,"Neither trial was able to clearly demonstrate that providing access to the online interventions lead to increased reductions in alcohol use as compared to the control group.
","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Centre for Addiction and Mental Health, 33 Russell St., Toronto, Ontario, M5S 2S1, Canada. john.cunningham@camh.ca.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Godinho', 'Affiliation': 'Centre for Addiction and Mental Health, 33 Russell St., Toronto, Ontario, M5S 2S1, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertholet', 'Affiliation': 'Alcohol Treatment Center, Department of Community Medicine and Health, Lausanne University Hospital, Lausanne, Vaud, Switzerland.'}]",BMC medical research methodology,['10.1186/s12874-019-0770-4']
584,31462178,System-integrated technology-enabled model of care (SINEMA) to improve the health of stroke patients in rural China: Statistical analysis plan for a cluster-randomized controlled trial.,"BACKGROUND


The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China.
OBJECTIVE


To present the detailed statistical analysis plan for the trial prior to database locking and data analysis.
METHODS


The detailed analysis plan outlines primary and secondary outcome measures, describes the over-arching data analysis principles to be adopted as well as more detailed descriptions of specific analytical approaches for effectiveness analyses, as well strategies to handle missing outcome data.
DISCUSSION


Publication of the statistical analysis plan increases the transparency of the data analysis procedure and reduces potential bias in trial reporting.
TRIAL REGISTRATION


The trial was registered with clinicaltrials.gov (NCT03185858).",2020,"BACKGROUND


The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China.
","['stroke in rural China', 'stroke patients in rural China']","['community-based multi-component intervention', 'System-integrated technology-enabled model of care (SINEMA']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],,0.245218,"BACKGROUND


The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China.
","[{'ForeName': 'Enying', 'Initials': 'E', 'LastName': 'Gong', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Jiangsu, China.'}, {'ForeName': 'Lijing L', 'Initials': 'LL', 'LastName': 'Yan', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Jiangsu, China.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'McCormack', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Janet Prvu', 'Initials': 'JP', 'LastName': 'Bettger', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019869707']
585,31339533,Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial.,"Importance


More than 500 000 laypeople in the United States have been trained in hemorrhage control, including tourniquet application, under the Stop the Bleed campaign. However, it is unclear whether after hemorrhage control training participants become proficient in a specific type of tourniquet or can also use other tourniquets effectively.
Objective


To assess whether participants completing the American College of Surgeons Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs) can effectively apply bleeding control principles using other tourniquet types (commercial and improvised).
Design, Setting, and Participants


This nonblinded, crossover, sequential randomized clinical trial with internal control assessed a volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018. The order of application varied for each participant using randomly generated permutated blocks.
Interventions


Full B-Con course, including cognitive and skill sessions, that taught bleeding care, wound pressure and packing, and CAT application.
Main Outcomes and Measures


Correct tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap) in a simulated scenario for 3 commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test.
Results


A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study. Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%; Rapid Application Tourniquet System, 11.8%) and the improvised tourniquet (32.4%) (P < .001 for each pairwise comparison). When comparing tourniquets applied correctly, all tourniquet types had higher estimated blood loss, had longer application time, and applied less pressure than the CAT.
Conclusions and Relevance


The B-Con principles for correct CAT application are not fully translatable to other commercial or improvised tourniquet types. This study demonstrates a disconnect between the B-Con course and tourniquet designs available for bystander first aid, potentially stemming from the lack of consensus guidelines. These results suggest that current B-Con trainees may not be prepared to care for bleeding patients as tourniquet design evolves.
Trial Registration


ClinicalTrials.gov identifier: NCT03538379.",2019,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","['participants completing the American College of Surgeons', 'A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study', 'volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018', 'American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types']",['Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs'],"['commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test', 'blood loss', 'Measures\n\n\nCorrect tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0442588', 'cui_str': 'Stadium (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",102.0,0.0461564,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'McCarty', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Zain G', 'Initials': 'ZG', 'LastName': 'Hashmi', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Herrera-Escobar', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elzerie', 'Initials': 'E', 'LastName': 'de Jager', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muhammad Ali', 'Initials': 'MA', 'LastName': 'Chaudhary', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Lipsitz', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Caterson', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goralnick', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA surgery,['10.1001/jamasurg.2019.2275']
586,31320345,Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial.,"INTRODUCTION


Peripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations. This study aims to explore whether wearing textured insoles for 4 weeks alters balance performance in adults with diabetic peripheral neuropathy.
METHODS AND ANALYSIS


A prospective, single-blinded randomised controlled trial with parallel groups will be conducted on 70 adults with diabetic peripheral neuropathy. Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20 m (with/without an assistive device), will be recruited. Participants will be randomised to receive a textured insole (n=35) or smooth insole (n=35), to be worn for 4 weeks. During baseline and post intervention assessments, standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured). The primary outcome measure will be centre of pressure (CoP) velocity, with higher values indicating poorer balance. Secondary outcome measures include walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion). Patient-reported outcomes will be completed evaluating foot health, frequency of falls and fear of falling. Data will be analysed using a repeated measures mixed models approach (including covariates) to establish any differences between-groups, for all outcome measures, over the intervention period.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the institutional Human Research Ethics Committee (#2017000098). Findings will be disseminated at national and international conferences, through peer-reviewed journals, workshops and social media.
TRIAL REGISTRATION NUMBER


ACTRN12617000543381; Pre-results.",2019,"Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations.","['adults with diabetes', 'adults with diabetic peripheral neuropathy', '70 adults with diabetic peripheral neuropathy', 'Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20\u2009m (with/without an assistive device), will be recruited']","['Textured shoe insoles', 'textured insole (n=35) or smooth insole', 'standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured']","['walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion', 'foot health, frequency of falls and fear of falling', 'centre of pressure (CoP) velocity', 'balance performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}]","[{'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0205233', 'cui_str': 'Firm (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",70.0,0.223842,"Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations.","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hatton', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Gane', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jayishni N', 'Initials': 'JN', 'LastName': 'Maharaj', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Paton', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Kerr', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology - Kelvin Grove Campus, Brisbane, Queensland, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rome', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2018-026240']
587,31320353,Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND.,"INTRODUCTION


Poor adherence to photoprotection for people with xeroderma pigmentosum (XP) can be life-threatening. A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
METHODS AND ANALYSIS


A two-armed parallel groups RCT, where we randomised 24 patients with suboptimal adherence to either an intervention group who received XPAND in 2018 or a delayed intervention group who will receive XPAND in 2019. XPAND involves seven sessions, one-to-one with a facilitator, using behaviour change techniques and specially designed materials to target barriers to photoprotection. Following baseline assessment in April 2018 (t0) and intervention, the primary outcome will be measured across 21 consecutive days in June and July 2018 (t1). The primary outcome is the average daily UVR dose to the face (D-to-F), calculated by combining objective UVR exposure at the wrist (measured by a dosimeter) with face photoprotection activities recorded on a daily UVR protection diary. Secondary outcomes include average daily UVR D-to-F across 21 days in August (t2); psychosocial process variables measured by daily questions (t0, t1, t2) and self-report questionnaires (t0, t1, t2, December 2018 (t3)). Intervention cost-utility is assessed by service use and personal cost questionnaires (t0, t3). The delayed intervention control arm participants will complete three further assessments in April 2019 (t4) and June-July 2019 (t5), and December 2019 (t6) with dosimetry and UVR protection diary completed for 21 days at t4 and t5. A process evaluation will be conducted using mixed methods.
ETHICS AND DISSEMINATION


Ethical approval has been received from West London & GTAC REC 17/LO/2110. Results will be disseminated in peer-reviewed journals and at conferences. This study tests a novel intervention, which, if successful, will be integrated into routine care.
TRIAL REGISTRATION NUMBER


NCT03445052; Pre-results.",2019,"A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
","['adults with XP', 'people with xeroderma pigmentosum (XP', 'adults with Xeroderma Pigmentosum (XP', '24 patients with suboptimal adherence to either an intervention group who received']","['XPAND in 2018 or a delayed intervention group who will receive XPAND', 'personalised adherence intervention (XPAND', 'personalised adherence intervention']","['average daily UVR dose to the face (D-to-F), calculated by combining objective UVR exposure at the wrist (measured by a dosimeter) with face photoprotection activities recorded on a daily UVR protection diary', 'average daily UVR D-to-F across 21 days in August (t2); psychosocial process variables measured by daily questions (t0, t1, t2) and self-report questionnaires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043346', 'cui_str': 'Kaposi Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4082307', 'cui_str': 'Dosimeters'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",21.0,0.0897841,"A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Walburn', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sarkany', 'Affiliation': ""National Xeroderma Pigmentosum Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Sainsbury', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Araújo-Soares', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Myfanwy', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Canfield', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Foster', 'Affiliation': ""National Xeroderma Pigmentosum Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Heydenreich', 'Affiliation': 'Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Service & Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mander', 'Affiliation': 'MRC Biostatistics Unit, School of Clinical Medicine, Cambridge Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Falko F', 'Initials': 'FF', 'LastName': 'Sniehotta', 'Affiliation': 'Faculty of Medical Sciences, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Wulf', 'Affiliation': 'Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-028577']
588,31270082,Transient and chronic childhood immune thrombocytopenia are distinctly affected by Fc-γ receptor polymorphisms.,"In childhood immune thrombocytopenia (ITP), anti-platelet autoantibodies mediate platelet clearance through Fc-γ receptor (FcγR)-bearing phagocytes. In 75% to 90% of patients, the disease has a transient, self-limiting character. Here we characterized how polymorphisms of FcγR genes affect disease susceptibility, response to intravenous immunoglobulin (IVIg) treatment, and long-term recovery from childhood ITP. Genotyping of the  FCGR2/3  locus was performed in 180 children with newly diagnosed ITP, 22 children with chronic ITP, and 180 healthy control children by multiplex ligation-dependent probe amplification. Children with newly diagnosed ITP were randomly assigned to a single administration of IVIg or observation, and followed for 1 year (Treatment With or Without IVIg for Kids With ITP [TIKI] trial). We defined transient ITP as a complete recovery (≥100 × 10 9 /L) 3 months after diagnosis, including both self-limiting disease/IVIg responders and chronic ITP as absence of a complete recovery at 12 months. ITP susceptibility, as well as spontaneous recovery and response to IVIg, was associated with the genetic variants  FCGR2C *ORF and  FCGR2A *27W and the  FCGR2B  promoter variant 2B.4. These variants were overrepresented in patients with transient (N = 131), but not chronic (N = 43), disease. The presence of  FCGR2C *ORF predisposed to transient ITP with an odds ratio of 4.7 (95% confidence interval, 1.9-14.3). Chronic ITP was associated with a deletion of  FCGR2C/FCGR3B  (copy number region 1) with an odds ratio of 6.2 (95% confidence interval, 1.8-24.7). Taken together, susceptibility to transient and chronic ITP is distinctly affected by polymorphic variants of  FCGR2/3  genes. Our data suggest that genotyping of the  FCGR2/3  locus may be useful for prognosis and guidance of treatment decisions in newly diagnosed childhood ITP.",2019,"Chronic ITP was associated with a deletion of  FCGR2C/FCGR3B  (copy number region 1) with an odds ratio of 6.2 (95% confidence interval, 1.8-24.7).","['Children with newly diagnosed ITP', 'patients with transient (N = 131), but not chronic (N = 43), disease', '180 children with newly diagnosed ITP, 22 children with chronic ITP, and 180 healthy control children by multiplex ligation-dependent probe amplification']","['FCGR2C', 'FCGR2A']","['Transient and chronic childhood immune thrombocytopenia', 'ITP susceptibility']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3494189', 'cui_str': 'Multiplex Ligation-Dependent Probe Amplification'}]",[],"[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",180.0,0.0990693,"Chronic ITP was associated with a deletion of  FCGR2C/FCGR3B  (copy number region 1) with an odds ratio of 6.2 (95% confidence interval, 1.8-24.7).","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Schmidt', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Katja M J', 'Initials': 'KMJ', 'LastName': 'Heitink-Pollé', 'Affiliation': 'Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Annemieke G', 'Initials': 'AG', 'LastName': 'Laarhoven', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Marrie C A', 'Initials': 'MCA', 'LastName': 'Bruin', 'Affiliation': 'Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Barbera', 'Initials': 'B', 'LastName': 'Veldhuisen', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Sietse Q', 'Initials': 'SQ', 'LastName': 'Nagelkerke', 'Affiliation': 'Landsteiner Laboratory, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Taco W', 'Initials': 'TW', 'LastName': 'Kuijpers', 'Affiliation': 'Landsteiner Laboratory, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Porcelijn', 'Affiliation': 'Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.'}, {'ForeName': 'C Ellen', 'Initials': 'CE', 'LastName': 'van der Schoot', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Gestur', 'Initials': 'G', 'LastName': 'Vidarsson', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Masja', 'Initials': 'M', 'LastName': 'de Haas', 'Affiliation': 'Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, The Netherlands.'}]",Blood advances,['10.1182/bloodadvances.2019000068']
589,30807545,Cardiac Arrest Outcomes in Children With Preexisting Neurobehavioral Impairment.,"OBJECTIVES


To describe survival and 3-month and 12-month neurobehavioral outcomes in children with preexisting neurobehavioral impairment enrolled in one of two parallel randomized clinical trials of targeted temperature management.
DESIGN


Secondary analysis of Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital and Out-of-Hospital trials data.
SETTING


Forty-one PICUs in the United States, Canada, and United Kingdom.
PATIENTS


Eighty-four participants (59 in-hospital cardiac arrest and 25 out-of-hospital cardiac arrest), 49 males, 35 females, mean age 4.6 years (SD, 5.36 yr), with precardiac arrest neurobehavioral impairment (Vineland Adaptive Behavior Scales, Second Edition composite score < 70). All required chest compressions for greater than or equal to 2 minutes, were comatose and required mechanical ventilation after return of circulation.
INTERVENTIONS


Neurobehavioral function was assessed using the Vineland Adaptive Behavior Scales, Second Edition at baseline (reflecting precardiac arrest status), and at 3 and 12 months postcardiac arrest, followed by on-site cognitive evaluation. Vineland Adaptive Behavior Scales, Second Edition norms are 100 (mean) ± 15 (SD); higher scores indicate better function. Analyses evaluated survival, changes in Vineland Adaptive Behavior Scales, Second Edition, and cognitive functioning.
MEASUREMENTS AND MAIN RESULTS


Twenty-eight of 84 (33%) survived to 12 months (in-hospital cardiac arrest, 19/59 (32%); out-of-hospital cardiac arrest, 9/25 [36%]). In-hospital cardiac arrest (but not out-of-hospital cardiac arrest) survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment. Twenty-five survived with decrease in Vineland Adaptive Behavior Scales, Second Edition less than or equal to 15 (in-hospital cardiac arrest, 18/59 (31%); out-of-hospital cardiac arrest, 7/25 [28%]). At 3-months postcardiac arrest, mean Vineland Adaptive Behavior Scales, Second Edition scores declined significantly (-5; SD, 14; p < 0.05). At 12 months, Vineland Adaptive Behavior Scales, Second Edition declined after out-of-hospital cardiac arrest (-10; SD, 12; p < 0.05), but not in-hospital cardiac arrest (0; SD, 15); 43% (12/28) had unchanged or improved scores.
CONCLUSIONS


This study demonstrates the feasibility, utility, and challenge of including this population in clinical neuroprotection trials. In children with preexisting neurobehavioral impairment, one-third survived to 12 months and their neurobehavioral outcomes varied broadly.",2019,survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment.,"['Forty-one PICUs in the United States, Canada, and United Kingdom', 'children with preexisting neurobehavioral impairment enrolled in one of two parallel randomized clinical trials of targeted temperature management', 'Eighty-four participants (59 in-hospital cardiac arrest and 25 out-of-hospital cardiac arrest), 49 males, 35 females, mean age 4.6 years (SD, 5.36 yr), with precardiac arrest neurobehavioral impairment', 'Children With Preexisting Neurobehavioral Impairment']",[],"['survival rate', 'mean Vineland Adaptive Behavior Scales, Second Edition scores', 'hospital cardiac arrest', 'Vineland Adaptive Behavior Scales', 'survival, changes in Vineland Adaptive Behavior Scales, Second Edition, and cognitive functioning', 'Vineland Adaptive Behavior Scales, Second Edition declined after out-of-hospital cardiac arrest']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]",,0.0285492,survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment.,"[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Department of Pediatric Rehabilitation Medicine, Kennedy Krieger Institute, Baltimore, MD.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Faye S', 'Initials': 'FS', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001897']
590,30607527,"Associations Among Job Role, Training Type, and Staff Turnover in a Large-Scale Implementation Initiative.","Staff turnover is problematic for behavioral health agencies implementing evidence-based practices (EBPs), which are costly and time-consuming. The current study examined the association between EBP training methods and turnover and explored predictors of turnover for different types of staff. Participants (100 clinicians, 50 supervisors, 50 administrators) were randomized to one of three training conditions for an EBP. Results indicated low annual rates of turnover for clinicians, supervisors, and administrators. However, contrary to hypothesis, no statistically significant differences were found in rates of turnover across training conditions. Partially consistent with prior research, organizational climate was a significant predictor of supervisor and administrator turnover at 24 months, but was not a significant predictor of clinician turnover. Implications and future directions for research are discussed.",2019,The current study examined the association between EBP training methods and turnover and explored predictors of turnover for different types of staff.,"['Participants (100 clinicians, 50 supervisors, 50 administrators']",[],"['low annual rates of turnover for clinicians, supervisors, and administrators']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}]",,0.0197243,The current study examined the association between EBP training methods and turnover and explored predictors of turnover for different types of staff.,"[{'ForeName': 'Laurel A', 'Initials': 'LA', 'LastName': 'Brabson', 'Affiliation': 'Department of Psychology, West Virginia University, 1124 Life Sciences Building, P.O. Box 6040, Morgantown, WV, 26506-6040, USA. labrabson@mix.wvu.edu.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Herschell', 'Affiliation': 'Department of Psychology, West Virginia University, 1124 Life Sciences Building, P.O. Box 6040, Morgantown, WV, 26506-6040, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Mrozowski', 'Affiliation': ''}]",The journal of behavioral health services & research,['10.1007/s11414-018-09645-1']
591,31333262,Exploring the Consequences on Memory of Students Who Know They Have Access to Recorded Lectures.,"Objective.  To elucidate how students' knowledge of future access to recorded lectures impacts their ability to immediately recall, to delay recall, and to restudy information.  Methods.  Seventy-eight participants were randomly divided into two groups: knowledge of future access to recorded lectures after class and knowledge of no future access to recorded lectures after class. Participants viewed two mini lectures (10-12 minutes each) in a simulated classroom. Participants were told whether they would or would not be able to restudy lectures through future access to the recorded lectures just prior to their test one week later. Participants were tested immediately following the lectures and after a one-week delay. Prior to the delayed test, participants restudied one of the two lectures. The primary outcome was the participants' performance on the lecture material following immediate testing. Secondary outcomes included performance on delayed tests, performance after restudying the lectures and note-taking behavior.  Results.  Having access to a recorded lecture did not influence immediate recall. One week after the simulated class, reviewing videos did improve performance (d∼.70). Participants with knowledge of no future access forgot less information (d=.42) over time compared to the group that knew they had future access (d=.53); even though this latter group wrote longer notes.  Conclusion.  These findings suggest that there is no mnemonic-benefit to having knowledge of access to recorded classes. Reviewing recorded lectures did improve scores on an immediate test. However, participants with knowledge they had access to the recorded lectures to restudy them had larger effect sizes for loss of material.",2019,Participants with knowledge of no future access forgot less information (d=.42) over time compared to the group that knew they had future access (d=.53); even though this latter group wrote longer notes.  ,"['Students', 'Seventy-eight participants']",['knowledge of future access to recorded lectures after class and knowledge of no future access to recorded lectures after class'],"[""participants' performance on the lecture material following immediate testing"", 'performance on delayed tests, performance after restudying the lectures and note-taking behavior']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",78.0,0.0248975,Participants with knowledge of no future access forgot less information (d=.42) over time compared to the group that knew they had future access (d=.53); even though this latter group wrote longer notes.  ,"[{'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, North Carolina.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Yook', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, North Carolina.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mislan', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, North Carolina.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Persky', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, North Carolina.'}]",American journal of pharmaceutical education,['10.5688/ajpe6958']
592,31315868,"Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol.","INTRODUCTION


Youth and young adults living with HIV (YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy. This study in the San Francisco Bay area aims to evaluate the feasibility, acceptability and preliminary clinical outcomes of a 12-session telehealth counselling series provided to 80 YLWH, including education, motivational enhancement and problem-solving around HIV care, mental health, substance use and other challenges. Findings will provide information about benefits and challenges of telehealth counselling for YLWH and will guide the development of new technology-based strategies for care.
METHODS AND ANALYSIS


The Youth to Telehealth and Text to Improve Engagement in Care study is a pilot randomised, crossover trial examining the feasibility and acceptability of a telehealth counselling intervention consisting of twelve 20-30 min weekly sessions focused on identifying and problem-solving around barriers to HIV care access and adherence and on addressing mental health, substance use and/or other issues. Participants also receive text messages for check-ins, appointment reminders and to improve engagement. Participants complete quantitative online surveys at baseline, 4 and 8 months and qualitative exit interviews. Clinical outcomes, including plasma HIV RNA and CD4+ cell count, are collected from medical records. Study staff will explore outcomes of the intervention using quantitative and qualitative methods.
ETHICS AND DISSEMINATION


This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the community, participants and the academic community.
TRIAL REGISTRATION


NCT03681145.",2019,(YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy.,"['Youth and young adults living with HIV', 'youth living with HIV']",['Telehealth and texting intervention'],['plasma HIV RNA and CD4+ cell\u2009count'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.084734,(YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy.,"[{'ForeName': 'Angie R', 'Initials': 'AR', 'LastName': 'Wootton', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Legnitto', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Dawson-Rose', 'Affiliation': 'School of Nursing, Department of Community Health Systems, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Saberi', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028522']
593,31785536,Patterns of alcohol use and associated characteristics and HIV-related outcomes among a sample of African-American women living with HIV.,"BACKGROUND


Alcohol use is common among people living with HIV and negatively impacts care and outcomes. African-American women living with HIV are subject to vulnerabilities that may increase risk for alcohol use and associated HIV-related outcomes.
METHODS


We used baseline data from a randomized controlled trial of an HIV-related stigma-reduction intervention among African-American women living with HIV in Chicago and Birmingham (2013-2015). Patterns of alcohol use [any use, unhealthy alcohol use (UAU), heavy episodic drinking (HED)] were measured using the AUDIT-C. We assessed demographic, social, and clinical characteristics which may influence alcohol use and HIV-related outcomes which may be influenced by patterns of alcohol use in bivariate and multivariable analyses.
RESULTS


Among 220 African-American women living with HIV, 54 % reported any alcohol use, 24 % reported UAU, and 27 % reported HED. In bivariate analysis, greater depressive symptoms, lower religiosity, lower social support, marijuana, and crack/cocaine use were associated with patterns of alcohol use (p < 0.05). Marijuana and cocaine/crack use were associated with patterns of alcohol use in adjusted analysis (p < 0.05). In adjusted analysis, any alcohol use and HED were associated with lower likelihood of ART adherence (ARR = 0.72, 95 % CI: 0.53-0.97 and ARR = 0.65, 95 % CI: 0.44-0.96, respectively), and UAU was associated with lack of viral suppression (ARR = 0.78, 95 % CI: 0.63-0.96).
CONCLUSIONS


Findings suggest any and unhealthy alcohol use is common and associated with poor HIV-related outcomes in this population. Regular alcohol screening and intervention should be offered, potentially targeted to subgroups (e.g., those with other substance use).",2020,"In adjusted analysis, any alcohol use and HED were associated with lower likelihood of ART adherence (ARR = 0.72, 95 % CI: 0.53-0.97 and ARR = 0.65, 95 % CI: 0.44-0.96, respectively), and UAU was associated with lack of viral suppression (ARR = 0.78, 95 % CI: 0.63-0.96).
","['people living with HIV', 'African-American women living with HIV', 'African-American women living with HIV in Chicago and Birmingham (2013-2015', '220 African-American women living with HIV, 54 % reported any alcohol use, 24 % reported UAU, and 27 % reported HED']","['Regular alcohol screening and intervention', 'HIV-related stigma-reduction intervention']","['viral suppression', 'ART adherence', 'alcohol use [any use, unhealthy alcohol use (UAU), heavy episodic drinking (HED', 'depressive symptoms, lower religiosity, lower social support, marijuana, and crack/cocaine use']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0681189', 'cui_str': 'Religiosity (observable entity)'}, {'cui': 'C0037438'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",220.0,0.0616453,"In adjusted analysis, any alcohol use and HED were associated with lower likelihood of ART adherence (ARR = 0.72, 95 % CI: 0.53-0.97 and ARR = 0.65, 95 % CI: 0.44-0.96, respectively), and UAU was associated with lack of viral suppression (ARR = 0.78, 95 % CI: 0.63-0.96).
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lipira', 'Affiliation': 'Department of Health Services, University of Washington, 1959 NE Pacific St, Magnuson Health Sciences Center, Room H-680, Seattle, WA, 98195-7660, United States; Department of Global Health, University of Washington, Harris Hydraulics Laboratory, Box 357965, Seattle, WA, 98195-7965, United States. Electronic address: lauren.e.lipira@dhsoha.state.or.us.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, Box 357965, Seattle, WA, 98195-7965, United States; Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific Street, Box 356560, Room BB1644, Seattle, WA, 98195-6560, United States. Electronic address: deeparao@uw.edu.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, Box 357965, Seattle, WA, 98195-7965, United States. Electronic address: penevin@uw.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, Box 357965, Seattle, WA, 98195-7965, United States. Electronic address: kempc@uw.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, 645 North Michigan Avenue, Suite 926, Chicago, IL, 60611, United States. Electronic address: susan-cohn@northwestern.edu.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Ryals Public Health Building (RPHB), 1665 University Boulevard, Birmingham, AL, 35294-0022, United States. Electronic address: jmturan@uab.edu.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Psychology, University of Washington, 119A Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, United States. Electronic address: jsimoni@uw.edu.'}, {'ForeName': 'Michele P', 'Initials': 'MP', 'LastName': 'Andrasik', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutch, 1100 Fairview Ave N., Mail Stop E5-110, Seattle, WA, 98109, United States. Electronic address: mandrasik@fredhutch.org.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'Stroger Hospital of Cook County, Ruth M. Rothstein CORE Center, 2020 W. Harrison St, Chicago, IL, 60612, United States. Electronic address: afrench@cookcountyhhs.org.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'Department of Health Services, University of Washington, 1959 NE Pacific St, Magnuson Health Sciences Center, Room H-680, Seattle, WA, 98195-7660, United States; Public Health Sciences Division, Fred Hutch. 1100 Fairview Ave N., Mail Stop M3-C102, Seattle, WA, 98109, United States. Electronic address: junger@fredhutch.org.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA, 98195-7232, United States. Electronic address: heagerty@uw.edu.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Department of Health Services, University of Washington, 1959 NE Pacific St, Magnuson Health Sciences Center, Room H-680, Seattle, WA, 98195-7660, United States; Seattle-Denver Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System Health Services Research & Development, 1660 S. Columbian Way (S-152), Seattle, WA, 98108, United States. Electronic address: Emily.Williams3@va.gov.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107753']
594,31790979,The development and validation of a human screening model of tobacco abstinence.,"INTRODUCTION


Given the low efficacy of smoking cessation methods, an experimental medicine model indicating smoking abstinence would be of great benefit to the development of new treatments. Hence the sensitivity of cognitive tasks and ambulatory craving measures to smoking abstinence were investigated.
METHODS


Cognitive tasks and ambulatory ratings of craving were assessed for sensitivity to acute abstinence (experiment 1), and nicotine replacement therapy administration (NRT) (experiment 2).
RESULTS


In experiment 1 go/no-go performance was improved (Mean Difference [MD] -0.99, 95% CI: -1.90 to -0.08) and craving was lower (Regression Coefficient [RC] -33.39, 95% CI: -39.96 to -26.82) in satiated compared with abstinent smokers. There was no clear evidence that N-back (MD 0.64, 95% CI: -0.42 to 2.51), delay discounting (MD 0.01, 95% CI: 0.001 to 0.005) or dot probe performance (MD 0.61, 95% CI: -0.87 to 1.54) were sensitive to acute abstinence. In experiment 2 go/no-go performance was improved (MD 1.12, 95% CI: 0.16-2.08) and craving was lower (RC -18.59, 95% CI: -24.63 to -12.55) smokers abstinent overnight receiving NRT compared with placebo. There was no clear evidence that N-back (MD -0.25, 95% CI: -1.45 to 0.94), delay discounting (MD 0.01, 95% CI: -0.002 to 0.004) or dot probe performance (MD -0.49, 95% CI: -1.61 to -0.64) were sensitive to NRT.
CONCLUSIONS


Findings from two experiments converge to suggest that abstinence in smokers reliably increases ambulatory craving assessments and, to a lesser extent, decreases go/no-go task performance. These findings can be utilized in the development of an experimental medicine model to test novel treatments for smoking cessation.",2020,"In experiment 2 go/no-go performance was improved (MD 1.12, 95% CI: 0.16-2.08) and craving was lower (RC -18.59, 95% CI: -24.63 to -12.55) smokers abstinent overnight receiving NRT compared with placebo.",[],"['placebo', 'nicotine replacement therapy administration (NRT) (experiment 2']","['delay discounting', 'craving', 'sensitivity of cognitive tasks and ambulatory craving measures to smoking abstinence', 'dot probe performance', 'ambulatory craving assessments']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0449768', 'cui_str': 'Measured to (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0999506,"In experiment 2 go/no-go performance was improved (MD 1.12, 95% CI: 0.16-2.08) and craving was lower (RC -18.59, 95% CI: -24.63 to -12.55) smokers abstinent overnight receiving NRT compared with placebo.","[{'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Grabski', 'Affiliation': 'School of Experimental Psychology, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU) at the University of Bristol, Bristol, UK; UK Centre for Tobacco and Alcohol Studies, University of Bristol, UK; Clinical Psychopharmacology Unit, University College London, London, UK. Electronic address: m.grabski@ucl.ac.uk.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Nutt', 'Affiliation': 'Neuropsychopharmacology Unit, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Husbands', 'Affiliation': 'Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Experimental Psychology, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU) at the University of Bristol, Bristol, UK; UK Centre for Tobacco and Alcohol Studies, University of Bristol, UK.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107720']
595,31404569,The effects of message framing and healthcare provider recommendation on adult hepatitis B vaccination: A randomized controlled trial.,"Many adults in the U.S. do not receive recommended vaccines, and the research literature remains inconclusive on the best communication strategies for increasing this behavior. This study examined the association of message framing (gained-framed vs. loss-framed vs. control), and healthcare provider (HCP) recommendation (offered vs. recommended) on uptake of adult hepatitis B virus (HBV) vaccination in a high risk population using a 3 × 2 block design randomized controlled trial. Fear of shots, fear of vaccines, and perceived message framing were examined in secondary analyses. Of the 1747 participants, 47.7% (n = 833) received 0 doses of HBV vaccine, 27.8% (n = 485) received 1 dose, 10.4% received 2 doses, and 14.1% received all 3 recommended doses. There was not a significant interaction between message framing and HCP recommendation (p = .59). Mean number of doses received by the gain-framed group (m = 0.96) was not significantly different from the loss-framed group (m = 0.97, RR = 0.99, 95% CI = 0.88-1.12). However, those receiving any framing message received significantly more doses (m = 0.96) than those in the control condition (m = 0.81, RR = 1.17, 95%CI = 1.06-1.31). Participants who received a HCP recommendation received significantly more vaccine doses (m = 0.95) than those in the vaccine-offered condition (mean = 0.82, RR = 1.16, 95%CI = 1.05-1.28). These results suggest there is no difference in vaccine uptake between gain-frame and loss-frame messages, but both are better than a control message. These results also support advising HCP to provide a strong recommendation for vaccinations beyond merely offering it to patients. This study has implications for vaccine uptake beyond HBV, and can inform future research on effective vaccine communication research. Clinicaltrials.gov Identifier: NCT00739752. Registration date: August 20, 2008.",2019,"Mean number of doses received by the gain-framed group (m = 0.96) was not significantly different from the loss-framed group (m = 0.97, RR = 0.99, 95% CI = 0.88-1.12).","['1747 participants, 47.7% (n\u202f=\u202f833) received', 'adult hepatitis B vaccination']","['message framing and healthcare provider recommendation', '0 doses of HBV vaccine']","['uptake of adult hepatitis B virus (HBV) vaccination', 'Mean number of doses', 'Fear of shots, fear of vaccines, and perceived message framing', 'vaccine uptake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0474232', 'cui_str': 'Hepatitis B vaccination (procedure)'}]","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",1747.0,0.16417,"Mean number of doses received by the gain-framed group (m = 0.96) was not significantly different from the loss-framed group (m = 0.97, RR = 0.99, 95% CI = 0.88-1.12).","[{'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Kasting', 'Affiliation': 'Purdue University, Department of Health and Kinesiology, 800 W. Stadium Ave., West Lafayette, IN 47907, United States. Electronic address: mlkastin@purdue.edu.'}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Head', 'Affiliation': 'Indiana University-Purdue University Indianapolis, Department of Communication Studies, 425 University Boulevard, Indianapolis, IN 46202, United States. Electronic address: headkj@iupui.edu.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Indiana University Kelley School of Business, 801 W. Michigan Street, Indianapolis, IN 46202, United States. Electronic address: dcox@iupui.edu.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Cox', 'Affiliation': 'Indiana University Kelley School of Business, 801 W. Michigan Street, Indianapolis, IN 46202, United States. Electronic address: acox@iupui.edu.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Zimet', 'Affiliation': 'Indiana University School of Medicine, Department of Pediatrics, 410 W. 10th Street, Indianapolis, IN 46202, United States. Electronic address: gzimet@iu.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105798']
596,30798451,Comparing Educational Music Therapy Interventions via Stages of Recovery with Adults in an Acute Care Mental Health Setting: A Cluster-Randomized Pilot Effectiveness Study.,"The purpose of this cluster-randomized pilot effectiveness study was to compare two different group-based educational music therapy interventions with a control condition as measured by the stage model of recovery in adults on an acute care mental health unit. Participants (N = 69) were cluster-randomized to one of three single-session conditions: educational lyric analysis (ELA), educational songwriting (ESW), or control. ELA and ESW conditions targeted motivations for and factors contributing to recovery. Results indicated no significant between-group difference. However, ELA and ESW conditions tended to have slightly more favorable stage of recovery mean scores than the control condition. Generally, educational music therapy may be clinically relevant for impacting stage of recovery within the temporal parameters of a single session. As ELA and ESW conditions had similar results, the specific educational music therapy intervention did not affect results. Implications for clinical practice, limitations, and suggestions for future research are provided.",2019,"However, ELA and ESW conditions tended to have slightly more favorable stage of recovery mean scores than the control condition.","['adults on an acute care mental health unit', 'Participants (N\u2009=\u200969) were cluster-randomized to one of three']","['single-session conditions: educational lyric analysis (ELA), educational songwriting (ESW), or control', 'Educational Music Therapy Interventions', 'educational music therapy interventions', 'educational music therapy']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]",[],69.0,0.0652526,"However, ELA and ESW conditions tended to have slightly more favorable stage of recovery mean scores than the control condition.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverman', 'Affiliation': 'Music Therapy Program, University of Minnesota School of Music, 2106 4th Street South, Minneapolis, MN, 55455, USA. silvermj@umn.edu.'}]",Community mental health journal,['10.1007/s10597-019-00380-1']
597,32057687,Effects of Dance and Music on Pain and Fear During Childbirth.,"OBJECTIVE


To test the effects of dance and music and music alone on pain and fear during the active phase of labor among nulliparous women.
DESIGN


Single-blind, randomized, controlled study.
SETTING


A maternity and children's hospital in Konya Province, Turkey.
PARTICIPANTS


A total of 93 nulliparous, pregnant women who were in the active phase of labor at term gestation with single fetuses in cephalic presentation.
METHODS


We randomly assigned participants to one of three groups: dance and music, music alone, and usual care (control). We collected data four times during labor using a personal information form, labor monitoring form, visual analog scale (VAS), and Version A of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQA) to measure fear.
RESULTS


Based on multivariate analysis of variance, the effect of time and study group interaction on VAS and W-DEQA scores was statistically significant (p < .05), and the effect of study groups and time on VAS scores was statistically significant (p < .05). The effect of the study groups on W-DEQA scores was statistically significant (p < .05), but there was no statistically significant effect of time on W-DEQA scores (p > .05).
CONCLUSION


Dance and music and music alone significantly reduced pain and fear in nulliparous women during the active phase of labor. These interventions are easy for nurses and midwives to use, affordable, and effective, and they enable a woman and her partner to be actively engaged in the woman's care.",2020,"The effect of the study groups on W-DEQA scores was statistically significant (p < .05), but there was no statistically significant effect of time on W-DEQA scores (p > .05).
","['nulliparous women', ""A maternity and children's hospital in Konya Province, Turkey"", 'A total of 93 nulliparous, pregnant women who were in the active phase of labor at term gestation with single fetuses in cephalic presentation']","['Dance and music and music alone', 'Dance and Music', 'dance and music, music alone, and usual care (control', 'dance and music and music alone']","['visual analog scale (VAS), and Version A of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQA) to measure fear', 'pain and fear', 'time on W-DEQA scores', 'VAS and W-DEQA scores', 'VAS scores', 'W-DEQA scores', 'Pain and Fear During Childbirth']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C2979973'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}]",93.0,0.0875062,"The effect of the study groups on W-DEQA scores was statistically significant (p < .05), but there was no statistically significant effect of time on W-DEQA scores (p > .05).
","[{'ForeName': 'İlknur Münevver', 'Initials': 'İM', 'LastName': 'Gönenç', 'Affiliation': ''}, {'ForeName': 'Hacer Alan', 'Initials': 'HA', 'LastName': 'Dikmen', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.12.005']
598,30474893,Efficacy of Chinese herb Cistanche Yishen granules in treatment of tinnitus for patients with chronic nephritis.,"OBJECTIVE


This study aimed to investigate the efficacy of Chinese herb Cistanche Yishen granules (CYG) in the treatment of tinnitus for patients with chronic nephritis.
METHODS


A total of 89 adult patients were diagnosed with chronic glomerulonephritis from January 2016 to December 2017. All the patients were randomly divided into two groups, such as the control group and the CYG group. The efficacy of tinnitus was determined using tinnitus handicap inventory (THI), Pittsburgh sleep quality index (PSQI), pure tone audiometry (PTA), speech reception threshold (SRT), and visual analog scale (VAS) for tinnitus loudness and annoyance.
RESULTS


In both these two groups of patients, values of THI, PSQI, PTA, SRT, and VAS for tinnitus loudness and annoyance were significantly decreased after the treatment compared with those before treatment. However, all values in CYG group after the treatment were significantly lower than those in the control group.
CONCLUSION


CYG could apparently release the tinnitus symptoms in the patients with chronic nephritis. This study might give more clinical evidence for Cistanche in the treatment of tinnitus and give a new treatment method for the patients with tinnitus.",2019,"In both these two groups of patients, values of THI, PSQI, PTA, SRT, and VAS for tinnitus loudness and annoyance were significantly decreased after the treatment compared with those before treatment.","['patients with tinnitus', 'patients with chronic nephritis', '89 adult patients were diagnosed with chronic glomerulonephritis from January 2016 to December 2017']","['Chinese herb Cistanche Yishen granules', 'Chinese herb Cistanche Yishen granules (CYG']","['tinnitus handicap inventory (THI), Pittsburgh sleep quality index (PSQI), pure tone audiometry (PTA), speech reception threshold (SRT), and visual analog scale (VAS) for tinnitus loudness and annoyance', 'values of THI, PSQI, PTA, SRT, and VAS for tinnitus loudness and annoyance', 'tinnitus symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C2364010', 'cui_str': 'Chronic nephritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152451', 'cui_str': 'Chronic glomerulonephritis (disorder)'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0019240', 'cui_str': 'Herb (substance)'}, {'cui': 'C1038769', 'cui_str': 'Cistanche'}, {'cui': 'C2003492', 'cui_str': 'yishen'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0004292', 'cui_str': 'Audiometry, Pure-Tone'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",89.0,0.0172623,"In both these two groups of patients, values of THI, PSQI, PTA, SRT, and VAS for tinnitus loudness and annoyance were significantly decreased after the treatment compared with those before treatment.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'The First School of Clinical Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of TÇM, Tongren Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Meixiao', 'Initials': 'M', 'LastName': 'Sheng', 'Affiliation': 'Department of Nephrology, Jiangsu Province Hospital of TCM, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}]",Journal of cellular biochemistry,['10.1002/jcb.27833']
599,31916007,Age and gender differences in financial distress among hematopoietic cell transplant survivors.,"PURPOSE


Cancer has long-term financial consequences. Adolescent and young adult (AYA) and middle-aged cancer survivors may experience more financial toxicity than older adults. This study examined age differences in financial distress in hematopoietic cell transplant survivors and whether these differences result from measurement bias, more financial barriers to care, or an overall higher level of distress.
METHODS


Hematologic malignancy survivors (n = 1135, 2-10 years post-transplant) completed the Cancer and Treatment Distress Scale (CTXD) and demographics as part of the baseline assessment for a randomized clinical trial. The CTXD has seven subscales, but for this study, we examined the financial distress subscale and the overall score. Item response theory analyses tested for bias by age and gender. Multivariate linear regression tested the association of age and gender with the CTXD scores while controlling for financial barriers to care.
RESULTS


No bias was found on the CTXD. AYA (p < 0.01) and middle-aged adults (p < 0.001) reported more financial and overall distress than older (age 65+) adults. The same association of age and financial distress was observed in women (p < 0.01). However, only middle-aged men (p < 0.01) reported more financial and overall distress than older men; AYA men did not (p > 0.18). Financial barriers to care were not associated with financial or overall distress.
CONCLUSIONS


Part of the increase in financial distress with younger age may be due to a higher risk of general distress. Policy initiatives to control cancer costs should consider life stage and the unique financial challenges at different ages for men and women.",2020,"However, only middle-aged men (p < 0.01) reported more financial and overall distress than older men; AYA men did not (p > 0.18).","['Hematologic malignancy survivors (n\u2009=\u20091135, 2-10\xa0years post-transplant) completed the Cancer and Treatment Distress Scale (CTXD) and demographics as part of the baseline assessment for a randomized clinical trial', 'Adolescent and young adult (AYA) and middle-aged cancer survivors', 'older adults', 'hematopoietic cell transplant survivors']",[],"['financial distress', 'age and financial distress', 'financial and overall distress', 'financial distress subscale']","[{'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]",[],"[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0320963,"However, only middle-aged men (p < 0.01) reported more financial and overall distress than older men; AYA men did not (p > 0.18).","[{'ForeName': 'Salene M W', 'Initials': 'SMW', 'LastName': 'Jones', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Loren', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Navneet S', 'Initials': 'NS', 'LastName': 'Majhail', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whalen', 'Affiliation': 'University of Nebraska, Omaha, NB, USA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Leisenring', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mary E D', 'Initials': 'MED', 'LastName': 'Flowers', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA. ksyrjala@fredhutch.org.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05291-1']
600,32146720,Adjunctive effects of laser therapy on somatosensory function and vasomotor regulation of periodontal tissues in patients with periodontitis-A randomized controlled clinical trial.,"BACKGROUND


The purpose of this prospective study was to compare the changes in periodontal somatosensory function and microcirculation in patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy.
METHODS


Twenty-four patients suffering from periodontitis were recruited and randomly allocated into a split-mouth design to either SRP combined laser therapy side (test side) or SRP only side (control side). All treatments were performed by the same investigator at a single visit. Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST) were performed at baseline (W0), 1 week (1W), 2 weeks (2W), and 4 weeks (4W) after treatment on both sides of the attached gingiva of the maxillary lateral incisor. Clinical examination including probing depth (PD) and bleeding on probing (BOP) was performed at W0, 2W, and 4W on both sides. Data were analyzed with two-way analysis of variance.
RESULTS


PD and BOP significantly improved after treatment (P <0.001). LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792). Significantly less sensitivity was observed for all QST parameters (P <0.030) except for warmth detection after treatment.
CONCLUSION


Adjunctive use of laser therapy did not provide any significant clinical advantage or additional effects on the recovery of periodontal somatosensory function or gingival microcirculation in the present study.",2020,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","['patients with periodontitis', 'patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy', 'Twenty-four patients suffering from periodontitis']","['laser therapy', 'SRP combined laser therapy side (test side) or SRP only side (control side']","['somatosensory function and vasomotor regulation of periodontal tissues', 'periodontal somatosensory function or gingival microcirculation', 'LDF values', 'Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST', 'PPD and BOP', 'sensitivity', 'pocket probing depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",24.0,0.0325481,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Gou', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ruyi', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kelun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Journal of periodontology,['10.1002/JPER.19-0562']
601,31220200,"Long-term effect of community-based continence promotion on urinary symptoms, falls and healthy active life expectancy among older women: cluster randomised trial.","BACKGROUND


The long-term effectiveness of group continence promotion delivered via community organisations on female urinary incontinence, falls and healthy life expectancy remains unknown.
METHODS


A pragmatic cluster randomised trial was conducted among 909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France. A total of 184 organisations were randomised to an in-person 60-min incontinence self-management workshop (461 participants), and 193 to a control healthy ageing workshop (448 participants). The primary outcome was self-reported incontinence improvement at 1-year. Falls and gains in health utility were secondary outcomes.
RESULTS


A total 751 women, mean age 78.0, age range 65-98 completed the trial (83%). At 1-year, 15% of the intervention group versus 6.9% of controls reported significant improvements in urinary symptoms, (difference 8.1%, 95% confidence intervals (CI) 4.0-12.1%, intracluster correlation 0.04, number-needed-to-treat 13) and 35% versus 19% reported any improvement (risk difference 16.0%, 95% CI 10.4-21.5, number-needed-to-treat 6). The proportion of fallers decreased from 42% to 36% in the intervention group (-8.0%, 95% CI -14.8 - -1.0) and from 44% to 34% in the control group (-10.3%, 95% CI -17.4 - -3.6), no difference between groups. Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
CONCLUSION


Community-based group continence promotion achieves long-term benefits on older women's urinary symptoms, without improvement in falls or healthy life expectancy compared with participation in a healthy ageing workshop.",2019,"Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
","['A total 751 women, mean age 78.0, age range 65-98 completed the trial (83', '909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France', ""older women's urinary symptoms"", 'A total of 184 organisations', 'older women', '461 participants), and 193 to a control healthy ageing workshop (448 participants']","['Community-based group continence promotion', 'group continence promotion delivered via community organisations', 'community-based continence promotion', 'person 60-min incontinence self-management workshop']","['urinary symptoms, falls and healthy active life expectancy', 'proportion of fallers', 'Falls and gains in health utility', 'self-reported incontinence improvement at 1-year', 'gain in health utility', 'urinary symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",909.0,0.343054,"Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups.
","[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Department of Geriatrics, Faculty of Medicine, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Fritel', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculté de Médecine et Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Halme', 'Affiliation': 'Department of Geriatrics, Internal Medicine Resident, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Clinical Sciences, Brunel Institute for Ageing Studies, Brunel University, Uxbridge, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jutai', 'Affiliation': 'Department of Health Sciences, Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Ontario Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Geriatrics, Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}]",Age and ageing,['10.1093/ageing/afz038']
602,31223148,Effectiveness of a Medication Reconciliation Simulation in an Introductory Pharmacy Practice Experience Course.,"Objective.  To evaluate the effectiveness of a simulated learning exercise on pharmacy students' ability and perception of their ability to perform medication reconciliation.  Methods.  Third-year pharmacy students were divided into three groups. Group A attended a 30-minute lecture; group B attended the lecture and participated in a 90-minute workshop; and group C received no training. After groups A and B completed their assigned learning activities, all students participated in a simulated medication reconciliation activity with a standardized patient (SP). Students also completed a pre- and post-intervention survey.  Results.  One hundred eighty-three students participated. Students in group B scored the highest (74.5%) on the SP activity compared to those in group A (68.9%) and group C (66.1%). Students in group B reported high levels of agreement with all statements describing the lecture, workshop, and SP activity, including that more of these activities should be integrated into the curriculum.  Conclusion.  A simulated learning exercise significantly improved students' ability to perform medication reconciliation, including obtaining an accurate medication list, correctly identifying medication discrepancies, and proposing appropriate resolutions. Simulated learning exercises should continue to be incorporated in pharmacy education, especially exercises for learning pharmacy practice skills such as medication reconciliation.",2019,Students in group B scored the highest (74.5%) on the SP activity compared to those in group A (68.9%) and group C (66.1%).,"['Third-year pharmacy students', 'One hundred eighty-three students participated']","['30-minute lecture; group B attended the lecture and participated in a 90-minute workshop; and group C received no training', 'simulated learning exercise', 'Medication Reconciliation Simulation', 'simulated medication reconciliation activity with a standardized patient (SP', 'Simulated learning exercises']",['SP activity'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",183.0,0.0125579,Students in group B scored the highest (74.5%) on the SP activity compared to those in group A (68.9%) and group C (66.1%).,"[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Komperda', 'Affiliation': 'Midwestern University Chicago College of Pharmacy, Downers Grove, Illinois.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lempicki', 'Affiliation': 'Midwestern University Chicago College of Pharmacy, Downers Grove, Illinois.'}]",American journal of pharmaceutical education,['10.5688/ajpe6628']
603,31262767,"Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with β-Lactam Antibiotics in Healthy Subjects.","SPR741 is a novel polymyxin B derivative, with minimal intrinsic antibacterial activity and reduced nonclinical nephrotoxicity compared to levels with polymyxin B, that interacts with the outer membrane of Gram-negative bacteria, enhancing penetration of coadministered antibiotics. The safety, tolerability, and pharmacokinetics (PK) of SPR741 were evaluated in two studies, after single and multiple intravenous (i.v.) doses in healthy adult subjects and after coadministration with partner antibiotics. In the single and multiple ascending-dose study, SPR741 or placebo was administered as a 1-h infusion at single doses of 5 to 800 mg and in multiple doses of 50 to 600 mg every 8 h (q8h) for 14 days. In the drug-drug interaction study, a single 400-mg i.v. dose of SPR741 was administered alone and in combination with piperacillin-tazobactam, ceftazidime, and aztreonam. PK parameters for SPR741 and partner antibiotics were determined using noncompartmental analysis. After single doses, a dose-linear and proportional increase in mean maximum concentration in plasma ( C   max ) and area under the concentration-time curve (AUC) was observed. At doses of 100 to 800 mg, >50% of the dose was excreted in the urine in the first 4 h postdose. After multiple doses, the mean half-life was 2.2 h on day 1 and up to 14.0 h on day 14, with no evidence of accumulation after 14 days of dosing up to 400 mg. The PK profile of SPR741 and partner antibiotics was unchanged with coadministration. SPR741 was generally well tolerated at doses up to 1,800 mg/day. These data support further clinical development of SPR741 for treating serious infections due to resistant bacteria. (These studies have been registered at ClinicalTrials.gov under identifiers NCT03022175 and NCT03376529.).",2019,The PK profile of SPR741 and partner antibiotics was unchanged with co-administration. SPR741 was generally well tolerated at doses up to 1800 mg/day.,"['Healthy Subjects', 'healthy adult subjects and after co-administration with partner antibiotics']","['SPR741', 'polymyxin', 'Beta-Lactam Antibiotics', 'piperacillin/tazobactam, ceftazidime, and aztreonam', 'SPR741 or placebo']","['PK parameters for SPR741 and partner antibiotics', 'PK profile of SPR741 and partner antibiotics', 'safety, tolerability, and pharmacokinetics (PK) of SPR741', 'Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741', 'mean C max  and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0032539', 'cui_str': 'Polymyxins'}, {'cui': 'C0026458', 'cui_str': 'Monocyclic beta-Lactams'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin / tazobactam'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0317922,The PK profile of SPR741 and partner antibiotics was unchanged with co-administration. SPR741 was generally well tolerated at doses up to 1800 mg/day.,"[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA peckburg@sperotherapeutics.com.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Lister', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Walpole', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Keutzer', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Utley', 'Affiliation': 'Spero Therapeutics, Cambridge, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tomayko', 'Affiliation': 'Pfizer, Inc., New York, New York, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kopp', 'Affiliation': 'E. Sullivan and Associates, LLC, Newburyport, Massachusetts, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Farinola', 'Affiliation': 'CMAX Clinical Research and Department of Clinical Pharmacology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00892-19']
604,31622684,Patient Portal Usage and Outcomes Among Adult Patients with Uncontrolled Asthma.,"BACKGROUND


Patient-clinician communication, essential for favorable asthma outcomes, increasingly relies on information technology including the electronic heath record-based patient portal. For patients with chronic disease living in low-income neighborhoods, the benefits of portal communication remain unclear.
OBJECTIVE


To describe portal activities and association with 12-month outcomes among low-income patients with asthma formally trained in portal use.
METHODS


In a longitudinal observational study within a randomized controlled trial, 301 adults with uncontrolled asthma were taught 7 portal tasks: reviewing upcoming appointments, scheduling appointments, reviewing medications, locating laboratory results, locating immunization records, requesting refills, and messaging. Half the patients were randomized to receive up to 4 home visits by community health workers. Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life were assessed over time and estimated as of 12 months from randomization.
RESULTS


Fewer than 60% of patients used the portal independently. Among users, more than half used less than 1 episode per calendar quarter. The most frequent activities were reading messages and viewing laboratory results and least sending messages and making appointments. Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12-month postintervention.
CONCLUSIONS


Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training. Usage was not associated with regular appointments or with clinical outcomes. Patient portals need modification to accommodate low-income patients with uncontrolled asthma.",2020,"Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12 months' post intervention.
","['low-income patients with uncontrolled asthma', 'patients with chronic disease living in low-income neighborhoods', 'low-income asthma patients formally trained in portal use', 'Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training', 'Adult Patients with Uncontrolled Asthma', '301 adults with uncontrolled asthma were taught 7 portal tasks']",[],"['quality of life', 'Patient Portal Usage and Outcomes', ""Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life""]","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",301.0,0.0512118,"Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12 months' post intervention.
","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Howell', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple University Health System, Philadelphia, Pa.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Maryori', 'Initials': 'M', 'LastName': 'Canales', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Localio', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.09.034']
605,31727580,"Algorithm-guided empirical tuberculosis treatment for people with advanced HIV (TB Fast Track): an open-label, cluster-randomised trial.","BACKGROUND


Tuberculosis, which is often undiagnosed, is the major cause of death among HIV-positive people. We aimed to test whether the use of a clinical algorithm enabling the initiation of empirical tuberculosis treatment by nurses in primary health-care clinics would reduce mortality compared with standard of care for adults with advanced HIV disease.
METHODS


In this open-label cluster-randomised controlled trial, we recruited individuals from 24 primary health-care clinics in South Africa. The clinics were randomly assigned (1:1) to either deliver an intervention or routine care (control) using computer-generated random numbers. Eligible participants were HIV-positive adults (aged ≥18 years) with CD4 counts of 150 cells per μL or less, who had not had antiretroviral therapy (ART) in the past 6 months or tuberculosis treatment in the past 3 months, and did not require urgent hospital referral. In intervention clinics, study nurses assessed participants on the basis of tuberculosis symptoms, body-mass index, point-of-care haemoglobin concentrations, and urine lipoarabinomannan assay results. Participants classified by a study algorithm as having high probability of tuberculosis (positive urine lipoarabinomannan assay, body-mass index <18·5 kg/m 2 , or haemoglobin concentration <100 g/L) were recommended to start tuberculosis treatment immediately followed by ART 2 weeks later; participants classified as medium probability (tuberculosis symptoms, no high probability criteria) were recommended to have symptom-guided investigation; and participants classified as low probability (no tuberculosis symptoms or high probability criteria) were recommended to start ART immediately. In standard-of-care clinics, participants received treatment in accordance with South African guidelines. Investigators and participants were aware of treatment allocation. The primary outcome was all-cause mortality at 6 months, assessed in the intention-to-treat population. Safety was also analysed in the intention-to treat population. This trial is registered with the ISRCTN registry, ISRCTN35344604, and the South African National Clinical Trials Register, DOH-27-0812-3902.
FINDINGS


Between Dec 19, 2012, and Dec 18, 2014, 3091 individuals were screened for eligibility, of whom 3053 were recruited, and 3022 (1507 participants in the intervention group and 1515 participants in the control group) were analysed for the primary outcome. 930 (61·7%) of 1507 participants in the intervention group versus 172 (11·4%) of 1515 participants in the control group had started tuberculosis treatment by 2 months. At 6 months, the mortality rate was 19·0 deaths per 100 person-years for the intervention group versus 21·6 deaths per 100 person-years in the control group (unadjusted hazard ratio [HR] 0·92, 95% CI 0·67-1·26, p=0·58; adjusted HR 0·87, 0·61-1·24, p=0·41). 28 (1·9%) of 1507 participants in the intervention group and ten (0·7%) of 1515 participants in the control group reported serious or severe adverse events. Grade 3 or 4 nausea and vomiting was the most common adverse event (ten participants in the intervention group and four participants in the control group). Among participants with adverse events, eight participants (six participants in the intervention group and two participants in the control group) died; none of the six deaths in the intervention group were attributed to the study intervention.
INTERPRETATION


Our intervention substantially increased coverage of tuberculosis treatment in this high-risk population, but did not reduce mortality.
FUNDING


Joint Global Health Trials (Medical Research Council, Department for International Development, Wellcome Trust).",2020,The clinics were randomly assigned (1:1) to either deliver an intervention or routine care (control) using computer-generated random numbers.,"['adults with advanced HIV disease', 'Between Dec 19, 2012, and Dec 18, 2014, 3091 individuals were screened for eligibility, of whom 3053 were recruited, and 3022 (1507 participants in the intervention group and 1515 participants in the control group', 'people with advanced HIV (TB Fast Track', '930 (61·7%) of 1507 participants in the intervention group versus 172 (11·4%) of 1515 participants in the control group had started tuberculosis treatment by 2 months', 'nurses in primary health-care clinics', 'Participants classified by a study algorithm as having high probability of tuberculosis (positive urine lipoarabinomannan assay, body-mass index', 'Eligible participants were HIV-positive adults (aged ≥18 years) with CD4 counts of 150 cells per μL or less, who had not had antiretroviral therapy (ART) in the past 6 months or tuberculosis treatment in the past 3 months, and did not require urgent hospital referral', 'recruited individuals from 24 primary health-care clinics in South Africa']","['Algorithm-guided empirical tuberculosis treatment', 'intervention or routine care (control) using computer-generated random numbers']","['serious or severe adverse events', 'mortality rate', 'Safety', 'cause mortality', 'Grade 3 or 4 nausea and vomiting']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0002045'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",1507.0,0.295803,The clinics were randomly assigned (1:1) to either deliver an intervention or routine care (control) using computer-generated random numbers.,"[{'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Grant', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK; Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: alison.grant@lshtm.ac.uk.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Charalambous', 'Affiliation': 'School of Public Health, University of the Witwatersrand, Johannesburg, South Africa; The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Tlali', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Karat', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Dorman', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hoffmann', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Foundation for Professional Development, Pretoria, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vassall', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Churchyard', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa; The Aurum Institute, Johannesburg, South Africa; Advancing Care and Treatment for TB/HIV, South African Medical Research Council, Johannesburg, South Africa.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Fielding', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30266-8']
606,31714954,Effect of Stopping Cotrimoxazole Preventive Therapy on Microbial Translocation and Inflammatory Markers Among Human Immunodeficiency Virus-Infected Ugandan Adults on Antiretroviral Therapy: The COSTOP Trial Immunology Substudy.,"BACKGROUND


Cotrimoxazole preventive therapy (CPT) in human immunodeficiency virus (HIV) infection is a World Health Organization-recommended standard of care in resource-limited settings, but the mechanism of CPT's beneficial effects is unclear. The COSTOP trial (ISRCTN44723643) evaluated the noninferiority of discontinuing CPT in stabilized patients on antiretroviral therapy. The COSTOP immunology substudy was conducted on a subset of COSTOP participants randomized to continue CPT (n = 86) or discontinue CPT (placebo, n = 86) as daily treatment for 1 year.
METHODS


We evaluated whether CPT reduces microbial translocation, indicated by the presence of bacterial lipopolysaccharide (LPS) and LPS control factors such as soluble CD14 (sCD14) and endotoxin core antibody (EndoCAb immunoglobulin M [IgM]) in plasma. Intestinal barrier damage as indicated by plasma intestinal fatty acid binding protein (IFABP), T-cell activation, and the inflammatory markers C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α) were also evaluated.
RESULTS


We found no significant change in markers of microbial translocation (LPS, IFABP, sCD14, and T-cell activation), with decreased EndoCAb IgM. There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
CONCLUSIONS


These results add to the evidence of immunological benefits of CPT among HIV-infected populations in resource-limited settings. However, no evidence of reducing microbial translocation was observed.",2020,"There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
","['stabilized patients on antiretroviral therapy', 'human immunodeficiency virus', 'Human Immunodeficiency Virus-Infected Ugandan Adults on Antiretroviral Therapy']","['discontinue CPT (placebo', 'Cotrimoxazole preventive therapy (CPT', 'Stopping Cotrimoxazole Preventive Therapy', 'CPT']","['Microbial Translocation and Inflammatory Markers', 'markers of microbial translocation (LPS, IFABP, sCD14, and T-cell activation', 'microbial translocation', 'inflammation markers (CRP and IL-6', 'plasma intestinal fatty acid binding protein (IFABP), T-cell activation, and the inflammatory markers C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α', 'EndoCAb IgM']","[{'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0163314', 'cui_str': 'Fatty Acid-Binding Proteins, Intestinal-Specific'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]",,0.1037,"There was significant increase in inflammation markers (CRP and IL-6) after stopping CPT compared to those who continued CPT.
","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kyosiimire-Lugemwa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Zacchaeus', 'Initials': 'Z', 'LastName': 'Anywaine', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Abaasa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gombe', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Musinguzi', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Munderi', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Pala', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz494']
607,31761958,"Topical rapamycin reduces markers of senescence and aging in human skin: an exploratory, prospective, randomized trial.","Aging is a major risk factor for the majority of human diseases, and the development of interventions to reduce the intrinsic rate of aging is expected to reduce the risk for age-related diseases including cardiovascular disease, cancer, and dementia. In the skin, aging manifests itself in photodamage and dermal atrophy, with underlying tissue reduction and impaired barrier function. To determine whether rapamycin, an FDA-approved drug targeting the mechanistic target of rapamycin (mTOR) complex, can reduce senescence and markers of aging in human skin, an exploratory, placebo-controlled, interventional trial was conducted in a clinical dermatology setting. Participants were greater than 40 years of age with evidence of age-related photoaging and dermal volume loss and no major morbidities. Thirty-six participants were enrolled in the study, and nineteen discontinued or were lost to follow-up. A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study. Clinical improvement in skin appearance was noted in multiple participants, and immunohistochemical analysis revealed improvement in histological appearance of skin tissue. Topical rapamycin reduced the expression of the p16 INK4A  protein consistent with a reduction in cellular senescence. This change was accompanied by relative improvement in clinical appearance of the skin and histological markers of aging and by an increase in collagen VII, which is critical to the integrity of the basement membrane. These results indicate that rapamycin treatment is a potential anti-aging therapy with efficacy in humans.Trial registration ClinicalTrials.gov Identifier: NCT03103893.",2019,A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study.,"['Participants were greater than 40 years of age with evidence of age-related photoaging and dermal volume loss and no major morbidities', 'human skin', 'Thirty-six participants were enrolled in the study, and nineteen discontinued or were lost to follow-up']","['rapamycin', 'Topical rapamycin']","['histological appearance of skin tissue', 'skin appearance', 'collagen VII protein levels']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0684084', 'cui_str': 'Skin tissue'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",36.0,0.0435227,A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study.,"[{'ForeName': 'Christina Lee', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ibiyonu', 'Initials': 'I', 'LastName': 'Lawrence', 'Affiliation': 'Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Dareen', 'Initials': 'D', 'LastName': 'Elgindi', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Nadhan', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Potnis', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Catlin', 'Initials': 'C', 'LastName': 'Sershon', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Binnebose', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Lorenzini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sell', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA. cs389@drexel.edu.'}]",GeroScience,['10.1007/s11357-019-00113-y']
608,31272393,Effect of prepaid and promised financial incentive on follow-up survey response in cigarette smokers: a randomized controlled trial.,"BACKGROUND


Monetary incentive is often used to increase response rate in smokers' survey, but such effect of prepaid and promised incentives in a follow-up survey is unknown. We compared the effect of different incentive schemes on the consent and retention rates in a follow-up survey of adult cigarette smokers.
METHODS


This was a randomized controlled trial (RCT) in Hong Kong, China. Smokers who completed a non-incentivized baseline telephone smoking survey were invited to a 3-month follow-up, with randomization into (1) the control group (no incentive), (2) a promised HK$100 (US$12.8) incentive upon completion, (3) a promised HK$200 (US$25.6) incentive upon completion, or (4) a prepaid HK$100 incentive plus another promised HK$100 incentive (""mixed incentive""). Crude risk ratios from log-binomial regression models were used to assess if the 3 incentive schemes predicted higher rates of consent at baseline or retention at 3-month than no incentive.
RESULTS


In total, 1246 smokers were enrolled. The overall consent and retention rates were 37.1 and 23.0%, respectively. Both rates generally increased with the incentive amount and offer of prepaid incentive. The mixed incentive scheme marginally increased the retention rate versus no incentive (26.8% vs 20.3%; risk ratio (RR) = 1.32; 95% CI: 1.00-1.76; P = 0.053), but not the consent rate (RR = 1.13; 95% CI: 0.93-1.38; P = 0.22). Among the consented participants, approximately 50% in the mixed incentive group received the mailed prepaid incentive, who achieved a higher retention rate than the group without incentives (82.8% vs 56.1%; RR = 1.48; 95% CI: 1.21-1.80; P < 0.01).
CONCLUSION


The mixed incentive scheme combining the prepaid and promised incentive was effective to increase the follow-up retention rate by 48%. We recommend this mixed incentive scheme to increase the follow-up retention rate. More efficient methods of delivering the incentive are needed to maximize its effects.
TRIAL REGISTRATION


U.S. Clinical Trials registry (clinicaltrials.gov, retrospectively registered, reference number: NCT03297866 ).",2019,The mixed incentive scheme combining the prepaid and promised incentive was effective to increase the follow-up retention rate by 48%.,"['adult cigarette smokers', 'cigarette smokers', 'Smokers who completed a non-incentivized baseline telephone smoking survey', '1246 smokers were enrolled']","['prepaid and promised financial incentive', 'control group (no incentive), (2) a promised HK$100 (US$12.8) incentive upon completion, (3) a promised HK$200 (US$25.6) incentive upon completion, or (4) a prepaid HK$100 incentive plus another promised HK$100 incentive (""mixed incentive']","['retention rate', 'consent rate', 'overall consent and retention rates', 'Crude risk ratios']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",1246.0,0.291575,The mixed incentive scheme combining the prepaid and promised incentive was effective to increase the follow-up retention rate by 48%.,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China. mpwang@hku.hk.'}, {'ForeName': 'Sai Yin', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Antonio Cho Shing', 'Initials': 'ACS', 'LastName': 'Kwong', 'Affiliation': 'The Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Vienna Wai Yin', 'Initials': 'VWY', 'LastName': 'Lai', 'Affiliation': 'The Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}]",BMC medical research methodology,['10.1186/s12874-019-0786-9']
609,31651545,Predictors of Viremia in Postpartum Women on Antiretroviral Therapy.,"BACKGROUND


HIV-infected, postpartum women on antiretroviral therapy (ART) have high rates of viremia. We examined predictors of postpartum viremia in the PROMISE study.
METHODS


Women with pre-ART CD4 T-cell counts ≥400 cells/mm who started ART during pregnancy were randomized postpartum to continue ART (CTART) or discontinue ART (DCART). Viral load and self-reported adherence were collected every 12 weeks, up to 144 weeks. Women in DCART reinitiated therapy when clinically indicated. Viremia was defined as 2 consecutive viral loads >1000 copies/mL after 24 weeks on ART. Adherence was dichotomized as missing versus not missing ART doses in the past 4 weeks. Predictors of viremia were examined using Cox proportional hazards regression with adherence as a time-varying covariate.
RESULTS


Among 802 women in the CTART arm, median age at entry was 27 years and median CD4 T-cell count 696 cells/mm. Of 175 women in CTART with viremia (22%), 141 had resistance data, and 12% had resistance to their current regimen. There was an estimated 0.12 probability of viremia by week 48 and 0.25 by week 144. Predictors of viremia included missed ART doses within the past 4 weeks, younger age, shorter duration of pre-entry ART, and being from the South American/Caribbean region. Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144).
CONCLUSIONS


Rates of postpartum viremia are high and viremia is more likely in younger postpartum women who start ART later in pregnancy. Interventions should target these higher-risk women.",2020,"Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144).
","['Postpartum Women on Antiretroviral Therapy', 'younger postpartum women who start ART later in pregnancy', 'Women with pre-ART CD4+ T-cell counts ≥400 cells/mm who started ART during pregnancy were randomized', '802 women in the CTART arm, median age at entry was 27 years and median CD4+ T-cell count 696 cells/mm ', '137 women in DCART who reinitiated therapy', 'HIV-infected, postpartum women on antiretroviral therapy (ART', '175 women in CTART with viremia (22']",['postpartum to continue (CTART) or discontinue treatment (DCART'],"['Viremia', 'probability of viremia', 'Adherence', 'Viral load and self-reported adherence']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",802.0,0.137621,"Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144).
","[{'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Meredith G', 'Initials': 'MG', 'LastName': 'Warshaw', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pilotto', 'Affiliation': 'JP, Fundação Oswaldo Cruz/IOC Laboratório de AIDS e Imunologia Molecular, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gaerolwe', 'Initials': 'G', 'LastName': 'Masheto', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Jullapong', 'Initials': 'J', 'LastName': 'Achalapong', 'Affiliation': 'Chiang Rai Prachanukroh Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Machado', 'Affiliation': 'Instituto de Puericultura e Pediatria Martagão Gesteira, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Duarte', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Esau', 'Initials': 'E', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Kathleen K', 'Initials': 'KK', 'LastName': 'Graham', 'Affiliation': ""Children's Diagnostic and Treatment Center, Fort Lauderdale, FL.""}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Knapp', 'Affiliation': ""Infectious Diseases Department, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Stek', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Southern CaliforniaLos Angeles, CA.'}, {'ForeName': 'Gwendolyn B', 'Initials': 'GB', 'LastName': 'Scott', 'Affiliation': 'School of Medicine, University of Miami Miller, Miami, FL.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Loftis', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH, Bethesda, MD.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002228']
610,31014399,Multiple antigen-engineered DC vaccines with or without IFNα to promote antitumor immunity in melanoma.,"BACKGROUND


Cancer vaccines are designed to promote systemic antitumor immunity and tumor eradication. Cancer vaccination may be more efficacious in combination with additional interventions that may build on or amplify their effects.
METHODS


Based on our previous clinical and in vitro studies, we designed an antigen-engineered DC vaccine trial to promote a polyclonal CD8 +  and CD4 +  T cell response against three shared melanoma antigens. The 35 vaccine recipients were then randomized to receive one month of high-dose IFNα or observation.
RESULTS


The resulting clinical outcomes were 2 partial responses, 8 stable disease and 14 progressive disease among patients with measurable disease using RECIST 1.1, and, of 11 surgically treated patients with no evidence of disease (NED), 4 remain NED at a median follow-up of 3 years. The majority of vaccinated patients showed an increase in vaccine antigen-specific CD8 +  and CD4 +  T cell responses. The addition of IFNα did not appear to improve immune or clinical responses in this trial. Examination of the DC vaccine profiles showed that IL-12p70 secretion did not correlate with immune or clinical responses. In depth immune biomarker studies support the importance of circulating Treg and MDSC for development of antigen-specific T cell responses, and of circulating CD8 +  and CD4 +  T cell subsets in clinical responses.
CONCLUSIONS


DC vaccines are a safe and reliable platform for promoting antitumor immunity. This combination with one month of high dose IFNα did not improve outcomes. Immune biomarker analysis in the blood identified several predictive and prognostic biomarkers for further analysis, including MDSC.
TRIAL REGISTRATION


NCT01622933 .",2019,The majority of vaccinated patients showed an increase in vaccine antigen-specific CD8 +  and CD4 +  T cell responses.,"['melanoma', '35 vaccine recipients']","['Multiple antigen-engineered DC vaccines with or without IFNα', 'IFNα or observation', 'DC vaccines', 'IFNα']","['vaccine antigen-specific CD8 +  and CD4 +  T cell responses', 'IL-12p70 secretion']","[{'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",,0.110489,The majority of vaccinated patients showed an increase in vaccine antigen-specific CD8 +  and CD4 +  T cell responses.,"[{'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Butterfield', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA. lbutterfield@parkerici.org.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Vujanovic', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Santos', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Maurer', 'Affiliation': 'Department of Immunology, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gambotto', 'Affiliation': 'Department of Surgery, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lohr', 'Affiliation': 'Department of Immunology, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'UPMC Hillman Cancer Center, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Waldman', 'Affiliation': 'Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Chandran', 'Affiliation': 'Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Tawbi', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Medicine, University of Pittsburgh, UPMC Hillman Cancer Center, 5117 Centre Avenue, Suite 1.27, Pittsburgh, PA, 15213, USA.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0552-x']
611,31126915,Tranexamic acid modulates the immune response and reduces postsurgical infection rates.,"Tranexamic acid (TXA) is an antifibrinolytic agent that blocks plasmin formation. Because plasmin is known to promote inflammatory and immunosuppressive responses, we explored the possibility that plasmin-mediated immunosuppression in patients undergoing cardiac surgery can be directly reversed by TXA and decrease postoperative infection rates. The modulatory effect of TXA on inflammatory cytokine levels and on innate immune cell activation were evaluated with multiplex enzyme-linked immunosorbent assay and flow cytometry, respectively. Postoperative infection rates were determined in patients undergoing cardiac surgery and randomized to TXA (ACTRN12605000557639; http://www.anzca.edu.au). We demonstrate that TXA-mediated plasmin blockade modulates the immune system and reduces surgery-induced immunosuppression in patients following cardiac surgery. TXA enhanced the expression of immune-activating markers while reducing the expression of immunosuppressive markers on multiple myeloid and lymphoid cell populations in peripheral blood. TXA administration significantly reduced postoperative infection rates, despite the fact that patients were being administered prophylactic antibiotics. This effect was independent of the effect of TXA at reducing blood loss. TXA was also shown to exert an immune-modulatory effect in healthy volunteers, further supporting the fibrin-independent effect of TXA on immune function and indicating that baseline plasmin levels contribute to the regulation of the immune system in the absence of any comorbidity or surgical trauma. Finally, the capacity of TXA to reduce infection rates, modulate the innate immune cell profile, and generate an antifibrinolytic effect overall was markedly reduced in patients with diabetes, demonstrating for the first time that the diabetic condition renders patients partially refractory to TXA.",2019,TXA enhanced the expression of immune-activating markers while reducing the expression of immunosuppressive markers on multiple myeloid and lymphoid cell populations in peripheral blood.,"['healthy volunteers', 'patients with diabetes', 'patients undergoing cardiac surgery', 'patients following cardiac surgery']","['TXA-mediated plasmin blockade', 'TXA', 'Tranexamic acid', 'Tranexamic acid (TXA']","['antifibrinolytic effect overall', 'blood loss', 'postsurgical infection rates', 'inflammatory cytokine levels', 'postoperative infection rates', 'Postoperative infection rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0003304', 'cui_str': 'Antifibrinolysins'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}]",,0.070241,TXA enhanced the expression of immune-activating markers while reducing the expression of immunosuppressive markers on multiple myeloid and lymphoid cell populations in peripheral blood.,"[{'ForeName': 'Dominik F', 'Initials': 'DF', 'LastName': 'Draxler', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kah', 'Initials': 'K', 'LastName': 'Yep', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Gryselda', 'Initials': 'G', 'LastName': 'Hanafi', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anoushka', 'Initials': 'A', 'LastName': 'Winton', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglas', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Ho', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maithili', 'Initials': 'M', 'LastName': 'Sashindranath', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wutzlhofer', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia; and.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Goncalves', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Huyen A', 'Initials': 'HA', 'LastName': 'Tran', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wallace', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Plebanski', 'Affiliation': 'School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Medcalf', 'Affiliation': 'Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia.'}]",Blood advances,['10.1182/bloodadvances.2019000092']
612,31274492,Post-thoracotomy ipsilateral shoulder pain: What should be preferred to optimize it - phrenic nerve infiltration or paracetamol infusion?,"Background


Post thoracotomy ipsilateral shoulder pain (PTISP) is a distressing and highly prevalent problem after thoracic surgery and has not received much attention despite the incidence as high as 85%.
Objectives


To study the effect of phrenic nerve infiltration with Ropivacaine compared to paracetamol infusion on PTISP in thoracotomy patients with epidural analgesia as standard mode of incisional analgesia in both the groups.
Study Design


Prospective Randomised and Double Blind Study.
Methods


126 adult patients were divided randomly into 2 groups, ""Group A (Phrenic Nerve Infiltration Group) received 10 mL of 0.2% Ropivacaine close to the diaphragm into the periphrenic fat pad"" and ""Group B (Paracetamol Infusion Group) received 20mg/kg paracetamol infusion"" 30 minutes prior to chest closure respectively. A blinded observer assessed the patients PTISP using the VAS score at 1, 4, 8, 12 and 24 hours (h) postoperatively. The time and number of any rescue analgesic medication were recorded.
Results


PTISP was relieved significantly in Group A (25.4℅) as compared to Group B (61.9℅), with significantly higher mean duration of analgesia in Group A. The mean time for first rescue analgesia was significantly higher in Group A (11.1 ± 7.47 hours) than in Group B (7.40 ± 5.30 hours). The number of rescue analgesic required was less in Group A 1.6 ± 1.16 as compared to Group B 2.9 ± 1.37 (P value <0.5).
Conclusions


Phrenic Nerve Infiltration significantly reduced the incidence and delayed the onset of PTISP as compared to paracetamol infusion and was not associated with any adverse effects.",2019,"The number of rescue analgesic required was less in Group A 1.6 ± 1.16 as compared to Group B 2.9 ± 1.37 (P value <0.5).
","['126 adult patients', 'Post-thoracotomy ipsilateral shoulder pain', 'thoracotomy patients with epidural analgesia as standard mode of incisional analgesia in both the groups']","['Group A (Phrenic Nerve Infiltration Group) received 10 mL of 0.2% Ropivacaine close to the diaphragm into the periphrenic fat pad"" and ""Group B (Paracetamol Infusion Group) received 20mg/kg paracetamol infusion"" 30 minutes prior to chest closure respectively', '\n\n\nPost thoracotomy ipsilateral shoulder pain (PTISP', 'Ropivacaine', 'paracetamol infusion']","['mean time for first rescue analgesia', 'mean duration of analgesia', 'time and number of any rescue analgesic medication', 'number of rescue analgesic required']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0031774', 'cui_str': 'Phrenic Nerve'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0935625', 'cui_str': 'Normal fat pad (body structure)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",126.0,0.0450682,"The number of rescue analgesic required was less in Group A 1.6 ± 1.16 as compared to Group B 2.9 ± 1.37 (P value <0.5).
","[{'ForeName': 'Sobia', 'Initials': 'S', 'LastName': 'Manzoor', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Talib', 'Initials': 'T', 'LastName': 'Khan', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care; Division of Cardiovascular and Thoracic Anaesthesia and Cardiac SICU, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Syed Amer', 'Initials': 'SA', 'LastName': 'Zahoor', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care; Division of Cardiovascular and Thoracic Anaesthesia and Cardiac SICU, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shaqul Qamar', 'Initials': 'SQ', 'LastName': 'Wani', 'Affiliation': 'Department of Radiation Oncology, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Jan Mohamad', 'Initials': 'JM', 'LastName': 'Rather', 'Affiliation': 'Department of General Surgery, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shaista', 'Initials': 'S', 'LastName': 'Yaqoob', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Zulfiqar', 'Initials': 'Z', 'LastName': 'Ali', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Zubair Ashraf', 'Initials': 'ZA', 'LastName': 'Hakeem', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Bashir Ahmad', 'Initials': 'BA', 'LastName': 'Dar', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher I Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_76_18']
613,31230933,"Incidence, determinants and impact of acute kidney injury in patients with diabetes mellitus and multivessel disease undergoing coronary revascularization: Results from the FREEDOM trial.","BACKGROUND


The incidence and prognostic significance of acute kidney injury (AKI) in patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization is not well known. The current analysis included patients randomized to PCI vs. CABG as part of the FREEDOM trial. We sought to examine the impact of AKI and its predictors in diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG.
METHODS


We conducted a pre-specified subgroup analysis of the FREEDOM trial to examine the incidence, correlates and impact of AKI according to revascularization strategy. AKI predictors were identified using multivariable logistic regression and associations between AKI and outcomes were examined using Cox regression. The primary endpoint was the composite occurrence of all-cause death, stroke or myocardial infarction at 5 years of follow-up.
RESULTS


KI occurred more frequently in patients following CABG (15.6%) compared with PCI (9.1%) (p < 0.001). AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001). There was a non-significant interaction (p-value = 0.89) between the revascularization method and AKI, supporting that AKI is a significant risk factor in both revascularization methods.
CONCLUSIONS


Although risk for AKI was higher in patients undergoing CABG, the impact of AKI on MACE was substantial irrespective of revascularization strategy. Preventive strategies to identify patients at risk for AKI are warranted to mitigate the long-term effects of this complication.",2019,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","['patients with diabetes mellitus and multivessel coronary artery disease undergoing coronary revascularization', 'diabetic patients with multivessel coronary artery disease undergoing PCI vs. CABG', 'patients with diabetes mellitus and multivessel disease undergoing coronary revascularization']",['PCI vs. CABG'],"['composite occurrence of all-cause death, stroke or myocardial infarction at 5\u202fyears of follow-up', 'higher risk for major cardiovascular events (MACE', 'KI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.272116,"AKI was associated with a higher risk for major cardiovascular events (MACE) at 5 years (34.6% vs. 20.5%, p < 0.001), an effect that remained large and significant irrespective of CABG (HR = 2.18 95% CI 1.44-3.31, p ≤0.001) or PCI (HR = 2.08 95% CI 1.35-3.21, p < 0.0001).","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Arbel', 'Affiliation': 'Department of Cardiology, Tel Aviv Medical Center, Affiliated with the University of Tel Aviv, Tel Aviv, Israel. Electronic address: yarona@tlvmc.gov.il.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, USA; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Taye H', 'Initials': 'TH', 'LastName': 'Hamza', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Siami', 'Affiliation': 'New England Research Institute (NERI), USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Canada.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.05.064']
614,30942898,Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials.,"OBJECTIVE


We examined the efficacy and safety of galcanezumab after treatment cessation in randomized double-blind, placebo-controlled, migraine prevention studies (EVOLVE-1; EVOLVE-2).
BACKGROUND


Galcanezumab is indicated for migraine prevention in adults.
METHODS


Adults with episodic migraine were enrolled into EVOLVE-1 and EVOLVE-2, which randomized 858 and 915 patients, respectively, to galcanezumab 120 mg (an initial 240-mg loading dose), galcanezumab 240 mg, or placebo, administered subcutaneously once monthly for 6 months. After treatment completion or discontinuation, patients entered a 4-month posttreatment period. Efficacy and safety from the posttreatment periods are reported.
RESULTS


Overall, 740 patients (EVOLVE-1) and 830 (EVOLVE-2) patients entered the posttreatment periods, about 95% and 96% of patients, respectively, completed. In EVOLVE-1, change from pre-randomization baseline in monthly migraine headache days decreased over the posttreatment period from (mean [SE]) 5.2 (0.4) days (Month 6) to 4.1 (0.4) days (Month 10) for 120 mg and from 5.3 (0.4) days (Month 6) to 3.8 (0.4) days (Month 10) for 240 mg, and was stable for placebo (3.4 [0.3] days [Month 6] to 3.3 [0.3] days [Month 10]); differences between each galcanezumab dose group and placebo were statistically significant at each month, except for galcanezumab 240 mg at Month 10 (120 mg vs placebo: P < .001 Months 1-6, P = .007 Month 7, P = .044 Month 8, P = .016 Month 9, and P = .042 Month 10; 240 mg vs placebo: P < .001 Months 1-7, P = .015 Month 8, P = .021 Month 9, and P = .238 Month 10). EVOLVE-2 showed similar results. In both trials, there were no statistically significant differences between treatment groups and placebo for time-to-first loss of 50% response. During the posttreatment periods, 1.6% (EVOLVE-1) and 2.3% (EVOLVE-2) of patients initiated migraine preventive treatments. At Month 10, quality of life among galcanezumab-treated patients was similar to those taking placebo. The most common posttreatment emergent adverse event was upper respiratory tract infections. There were no discontinuations due to adverse events during the posttreatment periods.
CONCLUSIONS


Galcanezumab treatment effects were reduced during the posttreatment periods, but did not return to baseline. There were no unexpected adverse events after galcanezumab cessation.",2019,"Months 1-7, P = .015","['Adults with episodic migraine were enrolled into EVOLVE-1 and EVOLVE-2, which randomized 858 and 915 patients', 'Patients With Migraine', 'migraine prevention in adults']","['galcanezumab 120\xa0mg (an initial 240-mg loading dose), galcanezumab 240\xa0mg, or placebo', 'Galcanezumab', 'placebo', 'galcanezumab']","['migraine headache days', 'adverse events', 'quality of life', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0332253', 'cui_str': 'Evolving (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",858.0,0.304465,"Months 1-7, P = .015","[{'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Menelaos', 'Initials': 'M', 'LastName': 'Voulgaropoulos', 'Affiliation': 'MedFirst Urgent Care & Family Practice, Statesville, NC, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kovacik', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13508']
615,30932360,Early Magnetic Resonance Imaging-Based Changes in Patients With Meniscal Tear and Osteoarthritis: Eighteen-Month Data From a Randomized Controlled Trial of Arthroscopic Partial Meniscectomy Versus Physical Therapy.,"OBJECTIVE


The present study was undertaken to evaluate changes in knee magnetic resonance imaging (MRI) findings over the course of 18 months in subjects with osteoarthritic change and meniscal tear treated with arthroscopic partial meniscectomy (APM) or nonoperatively with physical therapy (PT).
METHODS


We used 18-month follow-up data from the Meniscal Tear in Osteoarthritis Research Trial. MRI results were read with reference to the MRI Osteoarthritis Knee Score. We focused on 18-month change in bone marrow lesions (BMLs), cartilage thickness, cartilage surface area, osteophyte size, effusion-synovitis, and Hoffa-synovitis. We used multinomial logistic regression to assess associations between MRI-based changes in each feature and treatment type.
RESULTS


A total of 351 subjects were randomized, and 225 had both baseline and 18-month MRI results. In both treatment groups, patients experienced substantial changes in several MRI-based markers. In 60% of the APM group, versus 33% of the PT group, cartilage surface area damage advanced in ≥2 subregions (adjusted odds ratio 4.2 [95% confidence interval 2.0-9.0). Patients who underwent APM also had greater advancement in scores for osteophytes and effusion-synovitis. We did not find significant associations between treatment type and change in cartilage thickness, BMLs, or Hoffa-synovitis.
CONCLUSION


This cohort of patients with meniscal tear and osteoarthritis showed marked advancement in MRI-based features over 18 months. Patients treated with APM showed more advancement in some features compared to those treated nonoperatively. The clinical relevance of these early findings is unknown and requires further study.",2020,"We did not find significant associations between treatment type and change in cartilage thickness, BMLs, or Hoffa-synovitis.
","['Patients with Meniscal Tear and Osteoarthritis', '351 subjects were randomized and 225 had both baseline and 18-month MRI', 'subjects with osteoarthritic change (OA) and meniscal tear (MT) treated with']","['arthroscopic partial meniscectomy (APM) or non-operatively with physical therapy (PT', 'APM']","['cartilage thickness, BMLs, or Hoffa-synovitis', 'cartilage surface area damage advanced in ≥2 subregions', 'MRI OA Knee Score (MOAKS', 'bone marrow lesions (BMLs), cartilage thickness, cartilage surface area, osteophytes size, effusion-synovitis, and Hoffa-synovitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1956089', 'cui_str': 'Bone Spur'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}]",351.0,0.0360848,"We did not find significant associations between treatment type and change in cartilage thickness, BMLs, or Hoffa-synovitis.
","[{'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Collins', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Losina', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Marx', 'Affiliation': 'Weill Cornell Medicine, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, and Mercy Catholic Medical Center, Darby, Pennsylvania.'}, {'ForeName': 'Morgan H', 'Initials': 'MH', 'LastName': 'Jones', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Levy', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mandl', 'Affiliation': 'Weill Cornell Medicine, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Martin', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Rick W', 'Initials': 'RW', 'LastName': 'Wright', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Kurt P', 'Initials': 'KP', 'LastName': 'Spindler', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis care & research,['10.1002/acr.23891']
616,30690554,Different modulation effects of Tai Chi Chuan and Baduanjin on resting-state functional connectivity of the default mode network in older adults.,"The default mode network (DMN) plays an important role in age-related cognitive decline. This study aims to explore the modulation effect of two mind-body interventions (Tai Chi Chuan and Baduanjin) on DMN in elderly individuals. Participants between 50 and 70 years old were recruited and randomized into a Tai Chi Chuan, Baduanjin or control group. The Wechsler Memory Scale-Chinese Revision and resting-state fMRI scans were administered at baseline and following 12 weeks of exercise. Seed-based resting-state functional connectivity (rsFC) was calculated. We found that (i) compared to the Baduanjin group, Tai Chi Chuan was significantly associated with increased rsFC between the medial prefrontal cortex (mPFC) and right putamen/caudate and (ii) compared to the control group, Tai Chi Chuan increased posterior cingulate cortex rsFC with the right putamen/caudate, while Baduanjin decreased rsFC between the mPFC and orbital prefrontal gyrus/putamen. Baseline mPFC rsFC with orbital prefrontal gyrus was negatively correlated with visual reproduction subscore. These results suggest that both Tai Chi Chuan and Baduanjin can modulate the DMN, but through different pathways. Elucidating the mechanisms underlying different mind-body interventions may shed light on the development of new methods to prevent age-related diseases as well as other disorders associated with disrupted DMN.",2019,Baseline mPFC rsFC with orbital prefrontal gyrus was negatively correlated with visual reproduction subscore.,"['Participants between 50 and 70\xa0years old', 'elderly individuals', 'older adults']","['Tai Chi Chuan, Baduanjin or control group', 'two mind-body interventions (Tai Chi Chuan and Baduanjin', 'Tai Chi Chuan and Baduanjin']","['medial prefrontal cortex (mPFC) and right putamen/caudate and (ii', 'visual reproduction subscore', 'Seed-based resting-state functional connectivity (rsFC', 'posterior cingulate cortex rsFC', 'Wechsler Memory Scale-Chinese Revision and resting-state fMRI scans']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0222045'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}]",,0.0221111,Baseline mPFC rsFC with orbital prefrontal gyrus was negatively correlated with visual reproduction subscore.,"[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Fujian Rehabilitation Tech Co-innovation Center, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Fujian Key Laboratory of Rehabilitation Technology, Fuzhou, Fujian, China.'}, {'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Fujian Key Laboratory of Rehabilitation Technology, Fuzhou, Fujian, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Fujian Key Laboratory of Rehabilitation Technology, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiehua', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Affiliated Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Affiliated Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Mingge', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Jingfang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Fujian Key Laboratory of Rehabilitation Technology, Fuzhou, Fujian, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsz001']
617,30630380,Conservative Fluid Management After Sepsis Resuscitation: A Pilot Randomized Trial.,"RATIONALE:


The feasibility and clinical outcomes of conservative fluid management after sepsis resuscitation remain unknown.
OBJECTIVES:


To evaluate the effect of a conservative fluid management protocol on fluid balance and intensive care unit (ICU)-free days among patients with sepsis.
METHODS:


In a single-center phase II/III randomized trial, we enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3). Patients were randomized 1:1 to usual care or a conservative fluid management protocol. The protocol restricted intravenous fluid administration during shock to treatment of oliguria or increasing vasopressor requirement. In the absence of shock, loop diuretic infusion targeted equal fluid input and output each study day. The primary outcomes were mean daily fluid balance (phase II) and ICU-free days (phase III).
RESULTS:


At the completion of phase II (n = 30), the difference in mean daily fluid balance between groups (-398 mL) was less than the prespecified threshold (-500 mL) and the trial was stopped. Patients in the conservative fluid management (n = 15) and usual care (n = 15) groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90) of which only 14% was intravenous crystalloid or colloid. Loop diuretic infusion occurred more frequently in the conservative fluid management group (40% vs 0%; P = .02), and cumulative fluid output was 10 645 mL in the conservative fluid management group compared to 6286 mL in the usual care group ( P = .39). Hemodynamic, respiratory, and renal function did not differ between the groups.
CONCLUSIONS:


In this phase II trial, a conservative fluid management protocol did not decrease mean daily fluid balance by more than 500 mL among patients with sepsis.
REGISTRATION:


Clinicaltrials.gov ; NCT02159079.",2019,groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90),"['After Sepsis Resuscitation', 'patients with sepsis', 'Patients in the conservative fluid management (n = 15) and usual care (n = 15', 'enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3']","['intravenous crystalloid or colloid', 'Conservative Fluid Management', 'usual care or a conservative fluid management protocol', 'conservative fluid management protocol']","['cumulative fluid output', 'mean daily fluid balance (phase II) and ICU-free days (phase III', 'fluid balance and intensive care unit (ICU)-free days', 'Hemodynamic, respiratory, and renal function', 'mean daily fluid balance']","[{'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0035229', 'cui_str': 'Respiratory Insufficiency'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429635', 'cui_str': 'Fluid output (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.159543,groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90),"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': '1 Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': '2 Section of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': '1 Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': '3 Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': '1 Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of intensive care medicine,['10.1177/0885066618823183']
618,31127269,The effect of intravenous iron on erythropoiesis in older people with hip fracture.,"BACKGROUND


anaemia following hip fracture is common and associated with worse outcomes. Intravenous iron is a potential non-transfusion treatment for this anaemia and has been found to reduce transfusion rates in previous observational studies. There is good evidence for its use in elective surgical populations.
OBJECTIVE


to examine the impact of intravenous iron on erythropoiesis following hip fracture.
DESIGN


two-centre, assessor-blinded, randomised, controlled trial of patients with primary hip fracture and no contra-indications to intravenous iron.
METHOD


the intervention group received three doses of 200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK) on three separate days. Primary outcome was reticulocyte count at day 7 after randomisation. Secondary outcomes included haemoglobin concentration, complications and discharge destination. Eighty participants were randomised.
RESULTS


there was a statistically significantly greater absolute final reticulocyte count in the iron group (89.4 (78.9-101.3) × 109 cells l-1 (n = 39) vs. the control (72.2 (63.9-86.4)) × 109 cells l-1 (n = 41); P = 0.019; (mean (95% confidence intervals) of log-transformed data). There were no differences in final haemoglobin concentration (99.9 (95.7-104.2) vs. 102.0 (98.7-105.3) P = 0.454) or transfusion requirements in the first week (11 (28%) vs. 12 (29%); P = 0.899). Functional and safety outcomes were not different between the groups.
CONCLUSIONS


although intravenous iron does stimulate erythropoiesis following hip fracture in older people, the effect is too small and too late to affect transfusion rates. Trial Registry Numbers: ISRCTN:76424792; EuDRACT: 2011-003233-34.",2019,"CONCLUSIONS


although intravenous iron does stimulate erythropoiesis following hip fracture in older people","['patients with primary hip fracture and no contra-indications to intravenous iron', 'older people with hip fracture', 'older people', 'Eighty participants were randomised']","['200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK', 'intravenous iron']","['transfusion requirements', 'haemoglobin concentration, complications and discharge destination', 'absolute final reticulocyte count', 'final haemoglobin concentration', 'reticulocyte count', 'Functional and safety outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0529374', 'cui_str': 'Venofer'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.501554,"CONCLUSIONS


although intravenous iron does stimulate erythropoiesis following hip fracture in older people","[{'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Moppett', 'Affiliation': ""Anaesthesia and Critical Care Research Group, Division of Clinical Neuroscience, Queen's Medical Centre, University of Nottingham, Nottingham, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rowlands', 'Affiliation': 'Department of Anaesthesia, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Mannings', 'Affiliation': 'Department of Anaesthesia, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Marufu', 'Affiliation': 'Department of Healthcare of Older Life, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sahota', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, UK.'}]",Age and ageing,['10.1093/ageing/afz049']
619,31161726,Low pre-exercise muscle glycogen availability offsets the effect of post-exercise cold water immersion in augmenting PGC-1α gene expression.,"We assessed the effects of post-exercise cold-water immersion (CWI) in modulating PGC-1α mRNA expression in response to exercise commenced with low muscle glycogen availability. In a randomized repeated-measures design, nine recreationally active males completed an acute two-legged high-intensity cycling protocol (8 × 5 min at 82.5% peak power output) followed by 10 min of two-legged post-exercise CWI (8°C) or control conditions (CON). During each trial, one limb commenced exercise with low (LOW: <300 mmol·kg -1  dw) or very low (VLOW: <150 mmol·kg -1  dw) pre-exercise glycogen concentration, achieved via completion of a one-legged glycogen depletion protocol undertaken the evening prior. Exercise increased (P < 0.05) PGC-1α mRNA at 3 h post-exercise. Very low muscle glycogen attenuated the increase in PGC-1α mRNA expression compared with the LOW limbs in both the control (CON VLOW ~3.6-fold vs. CON LOW ~5.6-fold: P = 0.023, ES 1.22 Large) and CWI conditions (CWI VLOW ~2.4-fold vs. CWI LOW ~8.0 fold: P = 0.019, ES 1.43 Large). Furthermore, PGC-1α mRNA expression in the CWI-LOW trial was not significantly different to the CON LOW limb (P = 0.281, ES 0.67 Moderate). Data demonstrate that the previously reported effects of post-exercise CWI on PGC-1α mRNA expression (as regulated systemically via β-adrenergic mediated cell signaling) are offset in those conditions in which local stressors (i.e., high-intensity exercise and low muscle glycogen availability) have already sufficiently activated the AMPK-PGC-1α signaling axis. Additionally, data suggest that commencing exercise with very low muscle glycogen availability attenuates PGC-1α signaling.",2019,Exercise increased (P < 0.05),['nine recreationally active males completed an acute two-legged high'],"['intensity cycling protocol (8\xa0×\xa05\xa0min at 82.5% peak power output) followed by 10\xa0min of two-legged post-exercise CWI (8°C) or control conditions (CON', 'post-exercise cold-water immersion (CWI', 'limb commenced exercise with low (LOW: <300\xa0mmol·kg -1  dw) or very low (VLOW: <150\xa0mmol·kg -1  dw) pre-exercise glycogen concentration, achieved via completion of a one-legged glycogen depletion protocol undertaken the evening prior']","['Furthermore, PGC-1α mRNA expression', 'CON LOW limb', 'Exercise', 'PGC-1α mRNA expression']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0333670', 'cui_str': 'Glycogen depletion (morphologic abnormality)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}]","[{'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",1.0,0.0723902,Exercise increased (P < 0.05),"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Allan', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Sharples', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cocks', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Drust', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dutton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Hannah F', 'Initials': 'HF', 'LastName': 'Dugdale', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Mawhinney', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Clucas', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Hawkins', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Gregson', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}]",Physiological reports,['10.14814/phy2.14082']
620,31691397,Differences in nicotine intake and effects from electronic and combustible cigarettes among dual users.,"AIM


To describe systemic nicotine exposure and subjective effects of electronic cigarettes (e-cigarettes) in people who use both e-cigarettes and cigarettes (dual users), including within-subject comparisons of e-cigarette and cigarette use.
DESIGN


Two-arm, counterbalanced cross-over study. Participants used their usual brand of e-cigarette or cigarette during a standardized session in a 2-week study.
SETTING


Hospital research ward, San Francisco, CA, USA.
PARTICIPANTS


Thirty-six healthy (eight women, 28 men) participants.
MEASUREMENTS


Plasma nicotine was analyzed by gas chromatography-tandem mass spectrometry; nicotine withdrawal, urge to smoke and vape, affective states, craving, satisfaction and psychological reward were measured by standardized questionnaires.
FINDINGS


Compared with cigarettes, average maximum plasma nicotine concentration (C max  ) was lower with e-cigarettes [6.1 ± 5.5 ng/ml, mean ± standard deviation (SD) versus 20.2 ± 11.1 ng/ml, P < 0.001] and time of maximal concentration (T max  ) was longer (6.5 ± 5.4 versus 2.7 ± 2.4 minutes, P < 0.001). Use of both products resulted in a reduction in the severity of withdrawal symptoms, negative affect and urge to use either product. E-cigarettes were less rewarding and satisfying and reduced craving to a lesser degree than cigarettes. We were not able to detect any differences in withdrawal symptoms, affective states and urge to smoke cigarettes between e-cigarette and cigarette use.
CONCLUSION


Systemic nicotine exposure was, on average, lower with single use of e-cigarettes compared with cigarettes, and e-cigarettes were judged to be less satisfying and rewarding and reduced craving less than cigarettes.",2020,"Use of both products resulted in a reduction in the severity of withdrawal symptoms, negative affect, and urge to use either product.","['people who use both e-cigarettes and cigarettes (dual users), including within-subject comparisons of e-cigarette and cigarette use', 'Thirty-six healthy (8 women, 28 men) participants', 'Participants used their usual brand of e-cigarette or cigarette during a standardized session in a 2-week study']",['electronic cigarettes (e-cigarettes'],"['withdrawal symptoms, affective states, and urge to smoke cigarettes', 'time of maximal concentration (T max  ', 'average maximum plasma nicotine concentration (C max  ', 'gas chromatography-tandem mass spectrometry; nicotine withdrawal, urge to smoke and vape, affective states, craving, satisfaction, and psychological reward', 'severity of withdrawal symptoms, negative affect, and urge to use either product']","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0008555', 'cui_str': 'Gas Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",36.0,0.0326872,"Use of both products resulted in a reduction in the severity of withdrawal symptoms, negative affect, and urge to use either product.","[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Dempsey', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Havel', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14884']
621,32123242,Does resistance training have an effect on levels of ferritin and atherogenic lipids in postmenopausal women? - A pilot trial.,"The objective of this study was to determine if 15 weeks of resistance training (RT) can alter the levels of blood lipids, body iron status, and oxidative stress in postmenopausal women with vasomotor symptoms. Postmenopausal women enrolled in a randomised controlled trial were allocated to either a sedentary control group (n = 29) or a RT group (n = 26). Blood samples were taken at week-0 and week-15 for all participants. Blood lipids and iron status were measured via routine clinical analyses. Immunoassays were used to measure oxidative stress markers. The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol. Moreover, ferritin was positively correlated with atherogenic lipids while negatively correlated with high-density lipoprotein in RT women. This occurred without alterations in serum iron, transferrin, transferrin-saturation, C-reactive protein and oxidative stress markers. No differences were found in control women. This study suggests that RT in postmenopausal women both reduces levels of ferritin and counteracts atherogenic lipid profiles independent of an apparent oxidative mechanism. RT may be a beneficial intervention in postmenopausal women via an interaction between ferritin and lipids; however, further investigation in a larger cohort is essential.",2020,"The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol.","['postmenopausal women', 'postmenopausal women with vasomotor symptoms', 'Postmenopausal women']","['sedentary control group (n\u2009=\u200929) or a RT', 'resistance training (RT']","['levels of ferritin and atherogenic lipids', 'levels of blood lipids, body iron status, and oxidative stress', 'atherogenic lipids', 'oxidative stress markers', 'Blood lipids and iron status', 'serum iron, transferrin, transferrin-saturation, C-reactive protein and oxidative stress markers', 'ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein\xa0cholesterol']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]",,0.105155,"The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol.","[{'ForeName': 'Liam J', 'Initials': 'LJ', 'LastName': 'Ward', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. liam.ward@liu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hammar', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Lindh-Åstrand', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Berin', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lindblom', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. wei.li@liu.se.'}]",Scientific reports,['10.1038/s41598-020-60759-z']
622,32132842,Five Weeks of Aquatic-Calisthenic High Intensity Interval Training Improves Cardiorespiratory Fitness and Body Composition in Sedentary Young Adults.,"Aquatic exercise may be better tolerated by sedentary, overweight individuals than land-based exercise. The purpose of the present study was to determine the effects of five weeks of aquatic high-intensity interval training (AHIIT) using standard calisthenic pool exercises, on cardiorespiratory fitness and body composition in sedentary young adults. Eleven college-age participants (9 women, 2 men) completed 15 exercise sessions that included three sessions per week for five weeks. Each session consisted of a five-minute warm-up period, 25 minutes of exercise, and a five-minute cool down. A training progression based upon standard progression principals from a pilot study was implemented. The exercises consisted of 25 exercise intervals lasting 10-30 seconds in duration, utilizing combinations of 8-12 different exercises. Twenty-two standard aquatic upper body, lower body, and full body aerobic exercises, most of which utilized aquatic dumbbells or hand paddles, were performed in an AHIIT protocol during each exercise session. Reductions in body composition (32.6 to 30.6% fat), submaximal (169 to 165 b·min -1 ) and peak heart rate (199 to 192 b·min -1 ), submaximal VO 2  (21.7 to 19.3 ml·kg -1 ·min -1  and peak VO 2  (30.5 to 31.95 ml·kg -1 ·min -1 ) occurred from pre- to post-program. This is the first study to determine the effectiveness of standard aquatic calisthenic exercises used in an AHIIT protocol. Improvements in cardiorespiratory fitness and exercise economy as well as body composition were observed in these sedentary individuals.",2020,"Reductions in body composition (32.6 to 30.6% fat), submaximal (169 to 165 b·min -1 ) and peak heart rate (199 to 192 b·min -1 ), submaximal VO 2  (21.7 to 19.3 ml·kg -1 ·min -1  and peak VO 2  (30.5 to 31.95 ml·kg -1 ·min -1 ) occurred from pre- to post-program.","['Eleven college-age participants (9 women, 2 men) completed', 'Sedentary Young Adults', 'sedentary young adults']","['standard aquatic calisthenic exercises', 'Aquatic-Calisthenic High Intensity Interval Training', 'aquatic high-intensity interval training (AHIIT) using standard calisthenic pool exercises', '15 exercise sessions', 'Aquatic exercise', '25 exercise intervals lasting 10-30 seconds in duration, utilizing combinations of 8-12 different exercises']","['cardiorespiratory fitness and body composition', 'Cardiorespiratory Fitness and Body Composition', 'cardiorespiratory fitness and exercise economy', 'peak heart rate', 'body composition']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006759', 'cui_str': 'Calisthenics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0233458,"Reductions in body composition (32.6 to 30.6% fat), submaximal (169 to 165 b·min -1 ) and peak heart rate (199 to 192 b·min -1 ), submaximal VO 2  (21.7 to 19.3 ml·kg -1 ·min -1  and peak VO 2  (30.5 to 31.95 ml·kg -1 ·min -1 ) occurred from pre- to post-program.","[{'ForeName': 'Brittany B', 'Initials': 'BB', 'LastName': 'McDaniel', 'Affiliation': 'Department of Kinesiology and Health Studies, Southeastern Louisiana University, Hammond, LA, USA.'}, {'ForeName': 'Mildred R', 'Initials': 'MR', 'LastName': 'Naquin', 'Affiliation': 'Department of Kinesiology and Health Studies, Southeastern Louisiana University, Hammond, LA, USA.'}, {'ForeName': 'Bovorn', 'Initials': 'B', 'LastName': 'Sirikul', 'Affiliation': 'Department of Kinesiology and Health Studies, Southeastern Louisiana University, Hammond, LA, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Kraemer', 'Affiliation': 'Department of Kinesiology and Health Studies, Southeastern Louisiana University, Hammond, LA, USA.'}]",Journal of sports science & medicine,[]
623,32132832,Effects of Swimming with Added Respiratory Dead Space on Cardiorespiratory Fitness and Lipid Metabolism.,"The aim of this study was to investigate the circulatory, respiratory, and metabolic effects of induced hypercapnia via added respiratory dead space (ARDS) during moderate-intensity swimming in recreational swimmers. A mixed-sex sample of 22 individuals was divided into homogeneous experimental (E) and control (C) groups controlled for maximal oxygen uptake (VO 2 max). The intervention involved 50 min of front crawl swimming performed at 60% VO 2 max twice weekly for 6 consecutive weeks. ARDS was induced via tube breathing (1000 ml) in group E. An incremental exercise test was administered pre- and post-intervention to assess cardiorespiratory fitness (CRF) by measuring VO 2 max, carbon dioxide volume, respiratory minute ventilation, respiratory exchange ratio (RER), and heart rate at 50, 100, 150, 200 W and at maximal workload. Body mass index (BMI), fat mass (FM), and fat-free mass (FFM) were also measured. The mean difference in glycerol concentration (ΔGLY) was assessed after the first and last swimming session. No significant between-group differences were observed at post-intervention. No within-group differences were observed at post-intervention except for RER which increased in group E at maximal workload. A 6-week swimming intervention with ARDS did not enhance CRF. The RER increase in group E is not indicative of a substrate shift towards increased lipid utilization. No change in ΔGLY is evident of a lack of enhanced triglyceride hydrolyzation that was also confirmed by similar pre- and post-intervention BMI, FM, and FMM.",2020,No within-group differences were observed at post-intervention except for RER which increased in group E at maximal workload.,"['22 individuals', 'recreational swimmers']","['induced hypercapnia via added respiratory dead space (ARDS', 'Swimming with Added Respiratory Dead Space', 'ARDS was induced via tube breathing']","['Body mass index (BMI), fat mass (FM), and fat-free mass (FFM', 'glycerol concentration (ΔGLY', 'Cardiorespiratory Fitness and Lipid Metabolism', 'cardiorespiratory fitness (CRF) by measuring VO 2 max, carbon dioxide volume, respiratory minute ventilation, respiratory exchange ratio (RER), and heart rate', 'triglyceride hydrolyzation', 'RER', 'lipid utilization']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0035218', 'cui_str': 'Respiratory Dead Space'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.0561001,No within-group differences were observed at post-intervention except for RER which increased in group E at maximal workload.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Szczepan', 'Affiliation': 'Department of Swimming, University School of Physical Education in Wroclaw, Poland.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Michalik', 'Affiliation': 'Department of Physiology and Biochemistry, University School of Physical Education in Wroclaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Borkowski', 'Affiliation': 'Department of Physiology and Biochemistry, University School of Physical Education in Wroclaw, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Zatoń', 'Affiliation': 'Department of Swimming, University School of Physical Education in Wroclaw, Poland.'}]",Journal of sports science & medicine,[]
624,31974286,"Sodium Bicarbonate Supplementation and Urinary TGF- β 1 in Nonacidotic Diabetic Kidney Disease: A Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES


In early-phase studies of individuals with hypertensive CKD and normal serum total CO 2 , sodium bicarbonate reduced urinary TGF- β 1 levels and preserved kidney function. The effect of sodium bicarbonate on kidney fibrosis and injury markers in individuals with diabetic kidney disease and normal serum total CO 2  is unknown.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted a randomized, double-blinded, placebo-controlled study in 74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, and serum total CO 2  of 22-28 meq/L. Participants received oral sodium bicarbonate (0.5 meq/kg lean body wt per day;  n =35) or placebo ( n =39) for 6 months. The primary outcome was change in urinary TGF- β 1-to-creatinine from baseline to months 3 and 6. Secondary outcomes included changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR from baseline to months 3 and 6.
RESULTS


Key baseline characteristics were age 72±8 years, eGFR of 51±18 ml/min per 1.73 m 2 , and serum total CO 2  of 24±2 meq/L. Sodium bicarbonate treatment increased mean total CO 2  by 1.2 (95% confidence interval [95% CI], 0.3 to 2.1) meq/L, increased urinary pH by 0.6 (95% CI, 0.5 to 0.8), and decreased urinary ammonium excretion by 5 (95% CI, 0 to 11) meq/d and urinary titratable acid excretion by 11 (95% CI, 5 to 18) meq/d. Sodium bicarbonate did not significantly change urinary TGF- β 1/creatinine (difference in change, 13%, 95% CI, -10% to 40%; change within the sodium bicarbonate group, 8%, 95% CI, -10% to 28%; change within the placebo group, -4%, 95% CI, -19% to 13%). Similarly, no significant effect on KIM-1-to-creatinine (difference in change, -10%, 95% CI, -38% to 31%), fibronectin-to-creatinine (8%, 95% CI, -15% to 37%), NGAL-to-creatinine (-33%, 95% CI, -56% to 4%), or UACR (1%, 95% CI, -25% to 36%) was observed.
CONCLUSIONS


In nonacidotic diabetic kidney disease, sodium bicarbonate did not significantly reduce urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR over 6 months.",2020,Sodium bicarbonate did not significantly change urinary,"['74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30', 'individuals with hypertensive CKD and normal serum total CO 2 ', 'Nonacidotic Diabetic Kidney Disease', 'individuals with diabetic kidney disease and normal serum total CO 2']","['sodium bicarbonate', 'Sodium Bicarbonate Supplementation and Urinary TGF', 'oral sodium bicarbonate', 'placebo', 'Sodium bicarbonate', 'TGF']","['urinary pH', 'fibronectin-to-creatinine', 'urinary ammonium excretion', 'KIM-1-to-creatinine', 'NGAL-to-creatinine', 'change urinary', 'urinary titratable acid excretion', 'UACR', 'kidney fibrosis and injury markers', 'changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR', 'urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR', 'mean total CO 2', 'change in urinary TGF- β 1-to-creatinine']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0151650', 'cui_str': 'Renal fibrosis (disorder)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.452047,Sodium bicarbonate did not significantly change urinary,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Tristin', 'Initials': 'T', 'LastName': 'Bullshoe', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Kunani', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06600619']
625,30025502,"Microfinance and health interventions: Factors influencing loan repayment success with young men in Dar es Salaam, Tanzania.","Poverty is associated with numerous poor health outcomes. Youth unemployment in Tanzania is approximately 13.7%, and concentrates in urban areas. These youth lack relevant job skills and access to financial capital. Microfinance continues to be implemented globally to address poverty, and increasingly has been linked to health interventions. Men less frequently are recipients of microfinance loans. We offered microcredit to young men in an area of Dar es Salaam with high poverty as part of a randomised controlled-trial to assess the efficacy of a microfinance and health leadership intervention in preventing STI acquisition. We used mixed methods to understand predictors of successful loan repayment. Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment. Using a modified Poisson approach, our quantitative analysis showed that successful repayment was associated with business experience, education, increasing number of children, community of residence, percentage of network members trained in business, and repayment success of peer leaders. Our results suggest that enforcing group accountability and repayment rules, offering ongoing training, and using successful entrepreneurs as role models could increase repayment success in similar populations. These strategies could provide financial opportunity for men while minimising risk for microfinance institutions.",2019,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","['young men in an area of Dar es Salaam with high poverty', 'young men in Dar es Salaam, Tanzania']","['Microfinance and health interventions', 'microfinance and health leadership intervention']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",[],,0.0426746,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'School of International Service, American University, Washington DC, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Mwikoko', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deusdith', 'Initials': 'D', 'LastName': 'Kajuna', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leatherman', 'Affiliation': 'Department of Health Policy and Management, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}]",Global public health,['10.1080/17441692.2018.1501079']
626,32132845,"Isoinertial Eccentric-Overload Training in Young Soccer Players: Effects on Strength, Sprint, Change of Direction, Agility and Soccer Shooting Precision.","The isoinertial training method owes its efficacy to an accommodated resistance and optimal individualized eccentric overload. The aim of this study was to assess the effects of a 6-week isoinertial eccentric-overload training program - using a flywheel inertial device during the execution of specific soccer exercises - on explosive and reactive strength, sprint ability, change of direction (COD) performance and soccer shooting precision. Thirty-four junior soccer players were randomly assigned to a plyometric training group (PT) (n = 16, aged 13.36 ± 0.80), which underwent a six-week traditional soccer training program, and a flywheel eccentric overload group (FEO) (n = 18, aged 13.21 ± 1.21), which received additional training consisting of two inertial eccentric-overload training sessions per week. Pre and post intervention tests were carried out to assess explosive and reactive strength, sprint ability, COD ability, agility using the Y-agility test (YT) and soccer shooting precision. The FEO showed significantly higher values than the PT in squat jump height (SJh) (p = 0.01), drop jump height (DJh) (p = 0.003), 7 repeated hop test heights (p = 0.001), the Illinois test (ILL) (p = 0.001), and the Loughborough Soccer Shooting Test (SHOT) (p = 0.02). Finally, the FEO showed significant between-group differences in DJh (p = 0.007), ILL (p = 0.0002), YT (p = 0.002), a linear sprint test (SPRINT) (p = 0.001), and SHOT (p = 0.003). These results confirmed the positive effect of isoinertial training. The use of an isoinertial device to overload multidirectional movements in specific sport conditions leads to greater performance improvements than conventional soccer training. The absence of knowledge of the eccentric overload applied by the isoinertial device, which is different in any exercise repetition, may stimulate the athlete's neural adaptations, improving their soccer skills and in particular their soccer shooting precision.",2020,"The FEO showed significantly higher values than the PT in squat jump height (SJh) (p = 0.01), drop jump height (DJh) (p = 0.003), 7 repeated hop test heights (p = 0.001), the Illinois test (ILL) (p = 0.001), and the Loughborough Soccer Shooting Test (SHOT) (p = 0.02).","['Young Soccer Players', 'Thirty-four junior soccer players']","['Isoinertial Eccentric-Overload Training', 'six-week traditional soccer training program, and a flywheel eccentric overload group (FEO', 'plyometric training group (PT', 'isoinertial eccentric-overload training program', 'additional training consisting of two inertial eccentric-overload training sessions per week', 'conventional soccer training']","['explosive and reactive strength, sprint ability, change of direction (COD) performance and soccer shooting precision', 'linear sprint test (SPRINT', 'Strength, Sprint, Change of Direction, Agility and Soccer Shooting Precision', 'ILL', 'Illinois test (ILL', 'explosive and reactive strength, sprint ability, COD ability, agility using the Y-agility test (YT) and soccer shooting precision', 'Loughborough Soccer Shooting Test (SHOT']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0459207', 'cui_str': 'Cod'}]",34.0,0.0162557,"The FEO showed significantly higher values than the PT in squat jump height (SJh) (p = 0.01), drop jump height (DJh) (p = 0.003), 7 repeated hop test heights (p = 0.001), the Illinois test (ILL) (p = 0.001), and the Loughborough Soccer Shooting Test (SHOT) (p = 0.02).","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fiorilli', 'Affiliation': 'Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Intrieri', 'Initials': 'I', 'LastName': 'Mariano', 'Affiliation': 'Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Iuliano', 'Affiliation': 'Faculty of Psychology, eCampus University, Novedrate, Italy.'}, {'ForeName': 'Arrigo', 'Initials': 'A', 'LastName': 'Giombini', 'Affiliation': 'Department of Movement, Human and Health Sciences, Italian University of Sport and Movement of Rome ""Foro Italico"", Rome, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Movement, Human and Health Sciences, Italian University of Sport and Movement of Rome ""Foro Italico"", Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buonsenso', 'Affiliation': 'Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Calcagno', 'Affiliation': 'Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Cagno', 'Affiliation': 'Department of Movement, Human and Health Sciences, Italian University of Sport and Movement of Rome ""Foro Italico"", Rome, Italy.'}]",Journal of sports science & medicine,[]
627,29948573,Survey Response Rate and Quality in a Mental Health Clinic Population: Results from a Randomized Survey Comparison.,"Given the limited ability of informatics-based assessment technologies to reach individuals with serious mental health conditions, this study evaluated the feasibility and data quality of mail-out healthcare surveys in this population to assist in measure selection for a multi-site controlled implementation trial. Veterans were randomly selected from those who had received services at a mental health clinic in the Department of Veterans Affairs, and were randomly assigned to one of three questionnaire lengths. Survey length (48-127 items) was not associated with differences in response rate, percent of items missing, or data quality. However, internal consistency reliability was variable among scales and survey lengths. Additional analyses indicate the above measures of survey data quality may differ among respondents who are non-white and younger and have psychotic disorders. These results can inform survey protocols to ensure maximal representation of this vulnerable population in health planning and policy assessment.",2019,"Survey length (48-127 items) was not associated with differences in response rate, percent of items missing, or data quality.","['Veterans were randomly selected from those who had received services at a mental health clinic in the Department of Veterans Affairs', 'Mental Health Clinic Population', 'respondents who are non-white and younger and have psychotic disorders', 'individuals with serious mental health conditions']",[],"['Survey Response Rate and Quality', 'response rate, percent of items missing, or data quality']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",,0.0201136,"Survey length (48-127 items) was not associated with differences in response rate, percent of items missing, or data quality.","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Stolzmann', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 South Huntington Avenue, (152M), Boston, MA, 02130, USA. kelly.stolzmann@va.gov.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Meterko', 'Affiliation': 'Performance Measurement, VHA Office of Analytics and Business Intelligence (OABI), ENRM Veterans Affairs Medical Center, 200 Springs Road, Bedford, MA, 01730, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 South Huntington Avenue, (152M), Boston, MA, 02130, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Belanger', 'Affiliation': 'Oregon Health and Sciences University, 3181 S.W. Sam Jackson Park Rd., Portland, OR, 97239-3098, USA.'}, {'ForeName': 'Marjorie Nealon', 'Initials': 'MN', 'LastName': 'Seibert', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 South Huntington Avenue, (152M), Boston, MA, 02130, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, 150 South Huntington Avenue, (152M), Boston, MA, 02130, USA.'}]",The journal of behavioral health services & research,['10.1007/s11414-018-9617-8']
628,29183752,One-Year Comparison of a Community-Based Exercise Program Versus a Day Hospital-Based Exercise Program on Quality of Life and Mental Health in Severely Burned Children.,"OBJECTIVE


To compare the effects of long-term psychosocial functioning and mental health of a ""day hospital""-based exercise program (DAYEX) versus a community-based exercise program (COMBEX).
DESIGN


A prospective design that consisted of 2 groups (DAYEX and COMBEX).
SETTING


A children's hospital specialized in burn care.
PARTICIPANTS


Patients (N=18; DAYEX [n=9], COMBEX [n=9]) were assessed at intensive care unit discharge and up to 1 year postburn.
INTERVENTIONS


The Child Health Questionnaires (CHQ-Child Form [CHQ-CF87] and CHQ-Parent Form [CHQ-PF28]) were used to assess changes in quality of life from discharge to 1 year postburn.
MAIN OUTCOME MEASURES


CHQ-PF28 and CHQ-CF87.
RESULTS


Demographic characteristics and total body surface area burned were similar in both groups. Length of hospital stay was significant in the COMBEX group. CHQ-CF87 and CHQ-PF28 documented significant improvements in both groups between discharge and 1 year. Significance was evident in Physical Functioning, Bodily Pain, Self-Esteem, Change in Health, and Family Activities. CHQ-CF87 showed improvement in Family Cohesion in COMBEX more than DAYEX. CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX.
CONCLUSIONS


The proposed COMBEX program is feasible and beneficial physically, psychosocially, and mentally. The results show some improvements in the COMBEX group in optimizing function and health in severely burned children. The COMBEX group performed at least as well as the DAYEX group. Larger-scale studies are needed to validate current findings.",2020,"CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX.
","[""A children's hospital specialized in burn care"", 'Severely Burned Children', 'severely burned children', 'Patients (N=18; DAYEX [n=9], COMBEX [n=9]) were assessed at intensive care unit discharge and up to 1 year postburn']","['COMBEX', 'Community-Based Exercise Program', 'Day Hospital-Based Exercise Program', 'long-term psychosocial functioning and mental health of a ""day hospital""-based exercise program (DAYEX) versus a community-based exercise program (COMBEX']","['Child Health Questionnaires (CHQ-Child Form [CHQ-CF87', 'Physical Functioning, Bodily Pain, Self-Esteem, Change in Health, and Family Activities', 'Role/Social Limitations-Emotional, Bodily Pain, and Family Activities', 'CHQ-CF87 and CHQ-PF28', 'CHQ-PF28 and CHQ-CF87', 'Quality of Life and Mental Health', 'Length of hospital stay']","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0530492,"CHQ-PF28 showed improvement in Role/Social Limitations-Emotional, Bodily Pain, and Family Activities in COMBEX more than DAYEX.
","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Peña', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX. Electronic address: rapena@utmb.edu.'}, {'ForeName': 'Oscar E', 'Initials': 'OE', 'LastName': 'Suman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Andersen', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Herndon', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychology, University of Texas Medical Branch/Shriners Hospitals for Children, Galveston, TX.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2017.10.023']
629,29955866,Reasons for Opioid Discontinuation and Unintended Consequences Following Opioid Discontinuation Within the TOPCARE Trial.,"OBJECTIVE


To identify reasons for opioid discontinuation and post-discontinuation outcomes among patients in the Transforming Opioid Prescribing in Primary Care (TOPCARE) study.
DESIGN


In TOPCARE, an intervention to improve adherence to opioid prescribing guidelines, randomized intervention primary care providers (PCPs) received nurse care manager support, an electronic registry, academic detailing, and electronic tools, and control PCPs received electronic tools only.
SETTING


Four Boston safety net primary care practices.
SUBJECTS


Patients in both TOPCARE study arms who discontinued opioid therapy during the trial.
METHODS


Through chart review, we examined the reason for discontinuation and post-discontinuation outcomes: one or more PCP visits, one or more pain-related emergency department (ED) visits, evidence of opioid use disorder (OUD), and referral for OUD treatment.
RESULTS


Opioid discontinuations occurred in 83/586 (14.2%) intervention and 42/399 (10.5%) control patients (P = 0.09). Among patients who discontinued opioids, 81 (65%) discontinued for misuse, with no difference by group (P = 0.38). Aberrancy in monitoring (e.g., discordant urine drug test results) was the most common type of misuse prompting discontinuation (occurring in (51/83 [61%] of intervention patients vs 19/42 [45%, P = 0.08] of control patients). Intervention patients who discontinued opioids had less PCP follow-up (65% vs 88%, P < 0.01) compared with control patients. We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation.
CONCLUSIONS


The decreased follow-up among TOPCARE intervention patients who discontinued opioids highlights the need to understand unintended consequences of involuntary opioid discontinuations resulting from interventions to reduce opioid risk.",2019,"We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation.
","['patients in the Transforming Opioid', 'Subjects\n\n\nPatients in both TOPCARE study arms who discontinued opioid therapy during the trial']","['nurse care manager support, an electronic registry, academic detailing, and electronic tools, and control PCPs received electronic tools only']","['PCP visits, one or more pain-related emergency department (ED) visits, evidence of opioid use disorder (OUD), and referral for OUD treatment', 'PCP follow', 'pain-related ED visits, evidence of OUD, or OUD treatment referral', 'Opioid discontinuations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",,0.0552494,"We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation.
","[{'ForeName': 'Jawad M', 'Initials': 'JM', 'LastName': 'Husain', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'LaRochelle', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keosaian', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny124']
630,31974825,Testing individual baroreflex responses to hypoxia-induced peripheral chemoreflex stimulation.,"INTRODUCTION


Baroreflexes and peripheral chemoreflexes control efferent autonomic activity making these reflexes treatment targets for arterial hypertension. The literature on their interaction is controversial, with suggestions that their individual and collective influence on blood pressure and heart rate regulation is variable. Therefore, we applied a study design that allows the elucidation of individual baroreflex-chemoreflex interactions.
METHODS


We studied nine healthy young men who breathed either normal air (normoxia) or an air-nitrogen-carbon dioxide mixture with decreased oxygen content (hypoxia) for 90 min, with randomization to condition, followed by a 30-min recovery period and then exposure to the other condition for 90 min. Multiple intravenous phenylephrine bolus doses were applied per condition to determine phenylephrine pressor sensitivity as an estimate of baroreflex blood pressure buffering and cardiovagal baroreflex sensitivity (BRS).
RESULTS


Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182). Of the nine subjects, six had significantly lower BRS in hypoxia (p < 0.05), two showed a significantly decreased pressor response, and three showed a significantly increased pressor response to phenylephrine in hypoxia, likely through reduced baroreflex buffering (p < 0.05). On average, hypoxia decreased BRS by 6.4 ± 0.9 ms/mmHg (19.9 ± 2.0 vs. 14.12 ± 1.6 ms/mmHg; p < 0.001) but did not change the phenylephrine pressor response (p = 0.878).
CONCLUSION


We applied an approach to assess individual baroreflex-chemoreflex interactions in human subjects. A subgroup exhibited significant impairments in baroreflex blood pressure buffering and BRS with peripheral chemoreflex activation. The methodology may have utility in elucidating individual pathophysiology and in targeting treatments modulating baroreflex or chemoreflex function.",2020,"RESULTS


Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182).","['human subjects', 'arterial hypertension', 'nine healthy young men who breathed either normal air (normoxia) or an']","['air-nitrogen-carbon dioxide mixture with decreased oxygen content (hypoxia', 'phenylephrine']","['baroreflex blood pressure buffering and cardiovagal baroreflex sensitivity (BRS', 'baroreflex blood pressure buffering and BRS with peripheral chemoreflex activation', 'systolic blood pressure', 'baroreflex buffering', 'BRS in hypoxia', 'blood pressure and heart rate regulation', 'Hypoxia reduced arterial oxygen saturation', 'raised heart rate', 'pressor response', 'phenylephrine pressor response']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]",9.0,0.0254132,"RESULTS


Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182).","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Kronsbein', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Darius A', 'Initials': 'DA', 'LastName': 'Gerlach', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Heusser', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hoff', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Division of Medicine, Division of Clinical Pharmacology, Autonomic Dysfunction Service, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Ehmke', 'Affiliation': 'Institute of Cellular and Integrative Physiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR) and Chair of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany. jens.tank@dlr.de.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-019-00660-6']
631,29655496,"Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial.","BACKGROUND


Progress in malaria control is under threat by wide-scale insecticide resistance in malaria vectors. Two recent vector control products have been developed: a long-lasting insecticidal net that incorporates a synergist piperonyl butoxide (PBO) and a long-lasting indoor residual spraying formulation of the insecticide pirimiphos-methyl. We evaluated the effectiveness of PBO long-lasting insecticidal nets versus standard long-lasting insecticidal nets as single interventions and in combination with the indoor residual spraying of pirimiphos-methyl.
METHODS


We did a four-group cluster randomised controlled trial using a two-by-two factorial design of 48 clusters derived from 40 villages in Muleba (Kagera, Tanzania). We randomly assigned these clusters using restricted randomisation to four groups: standard long-lasting insecticidal nets, PBO long-lasting insecticidal nets, standard long-lasting insecticidal nets plus indoor residual spraying, or PBO long-lasting insecticidal nets plus indoor residual spraying. Both standard and PBO nets were distributed in 2015. Indoor residual spraying was applied only once in 2015. We masked the inhabitants of each cluster to the type of nets received, as well as field staff who took blood samples. Neither the investigators nor the participants were masked to indoor residual spraying. The primary outcome was the prevalence of malaria infection in children aged 6 months to 14 years assessed by cross-sectional surveys at 4, 9, 16, and 21 months after intervention. The endpoint for assessment of indoor residual spraying was 9 months and PBO long-lasting insecticidal nets was 21 months. This trial is registered with ClinicalTrials.gov, number NCT02288637.
FINDINGS


7184 (68·0%) of 10 560 households were selected for post-intervention survey, and 15 469 (89·0%) of 17 377 eligible children from the four surveys were included in the intention-to-treat analysis. Of the 878 households visited in the two indoor residual spraying groups, 827 (94%) had been sprayed. Reported use of long-lasting insecticidal nets, across all groups, was 15 341 (77·3%) of 19 852 residents after 1 year, decreasing to 12 503 (59·2%) of 21 105 in the second year. Malaria infection prevalence after 9 months was lower in the two groups that received PBO long-lasting insecticidal nets than in the two groups that received standard long-lasting insecticidal nets (531 [29%] of 1852 children vs 767 [42%] of 1809; odds ratio [OR] 0·37, 95% CI 0·21-0·65; p=0·0011). At the same timepoint, malaria prevalence in the two groups that received indoor residual spraying was lower than in groups that did not receive indoor residual spraying (508 [28%] of 1846 children vs 790 [44%] of 1815; OR 0·33, 95% CI 0·19-0·55; p<0·0001) and there was evidence of an interaction between PBO long-lasting insecticidal nets and indoor residual spraying (OR 2·43, 95% CI 1·19-4·97; p=0·0158), indicating redundancy when combined. The PBO long-lasting insecticidal net effect was sustained after 21 months with a lower malaria prevalence than the standard long-lasting insecticidal net (865 [45%] of 1930 children vs 1255 [62%] of 2034; OR 0·40, 0·20-0·81; p=0·0122).
INTERPRETATION


The PBO long-lasting insecticidal net and non-pyrethroid indoor residual spraying interventions showed improved control of malaria transmission compared with standard long-lasting insecticidal nets where pyrethroid resistance is prevalent and either intervention could be deployed to good effect. As a result, WHO has since recommended to increase coverage of PBO long-lasting insecticidal nets. Combining indoor residual spraying with pirimiphos-methyl and PBO long-lasting insecticidal nets provided no additional benefit compared with PBO long-lasting insecticidal nets alone or standard long-lasting insecticidal nets plus indoor residual spraying.
FUNDING


UK Department for International Development, Medical Research Council, and Wellcome Trust.",2018,The PBO long-lasting insecticidal net effect was sustained after 21 months with a lower malaria prevalence than the standard long-lasting insecticidal net (865 [45%] of 1930 children vs 1255,"['878 households visited in the two indoor residual spraying groups, 827 (94%) had been sprayed', '7184 (68·0%) of 10\u2008560 households were selected for post-intervention survey, and 15\u2008469 (89·0%) of 17\u2008377 eligible children from the four surveys were included in the intention-to-treat analysis', '1930 children vs 1255', '48 clusters derived from 40 villages in Muleba (Kagera, Tanzania']","['PBO long-lasting insecticidal nets versus standard long-lasting insecticidal nets', 'long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes', 'standard long-lasting insecticidal nets, PBO long-lasting insecticidal nets, standard long-lasting insecticidal nets plus indoor residual spraying, or PBO long-lasting insecticidal nets plus indoor residual spraying']","['control of malaria transmission', 'indoor residual spraying', 'prevalence of malaria infection', 'Malaria infection prevalence', 'malaria prevalence']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0332289', 'cui_str': 'Transmitted by (attribute)'}, {'cui': 'C0597329', 'cui_str': 'Pyrethroids'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",17377.0,0.0550709,The PBO long-lasting insecticidal net effect was sustained after 21 months with a lower malaria prevalence than the standard long-lasting insecticidal net (865 [45%] of 1930 children vs 1255,"[{'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Protopopoff', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: natacha.protopopoff@lshtm.ac.uk.'}, {'ForeName': 'Jacklin F', 'Initials': 'JF', 'LastName': 'Mosha', 'Affiliation': 'National Institute for Medical Research, Mwanza Medical Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Eliud', 'Initials': 'E', 'LastName': 'Lukole', 'Affiliation': 'Pan-African Malaria Vector Research Consortium, Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Jacques D', 'Initials': 'JD', 'LastName': 'Charlwood', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Mwalimu', 'Affiliation': 'Ministry of Health Community Development Gender Elderly and Children, National Malaria Control Program, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alphaxard', 'Initials': 'A', 'LastName': 'Manjurano', 'Affiliation': 'National Institute for Medical Research, Mwanza Medical Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Franklin W', 'Initials': 'FW', 'LastName': 'Mosha', 'Affiliation': 'Pan-African Malaria Vector Research Consortium, Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kisinza', 'Affiliation': 'National Institute for Medical Research, Amani Medical Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Immo', 'Initials': 'I', 'LastName': 'Kleinschmidt', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK; School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rowland', 'Affiliation': 'Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)30427-6']
632,31972601,Goal-directed therapy with bolus albumin 5% is not superior to bolus ringer acetate in maintaining systemic and mesenteric oxygen delivery in major upper abdominal surgery: A randomised controlled trial.,"BACKGROUND


Goal-directed therapy (GDT) is increasingly used in abdominal surgery. Whether crystalloids can exert the same effect as colloid, and how this may affect perfusion, is still unclear. The effect of GDT on the systemic oxygen delivery index (sDO2I) and the mesenteric oxygen delivery index (mDO2I) can be quantified by measuring cardiac index and flow in the superior mesenteric artery, respectively.
OBJECTIVE


The aim of this study was to test the hypothesis that intra-operative GDT with bolus human albumin 5% is superior to GDT with bolus ringer acetate in maintaining sDO2I and mDO2I in elective major upper gastrointestinal cancer surgery.
DESIGN


Randomised controlled double blinded trial.
SETTING


Odense University Hospital, Denmark, from May 2014 to June 2015.
PATIENTS


A total of 89 adults scheduled for elective major upper gastrointestinal cancer surgery were randomised and data from 60 were analysed.
EXCLUSION CRITERIA


contraindications for using the LiDCOplus system, known allergy to albumin, pre-operative renal failure, pancreatic cancer and pre-operative down staging using chemotherapy and/or radiation therapy, pregnancy.
INTERVENTIONS


Patients were randomised to intra-operative GDT with either bolus human albumin or ringer acetate 250 ml, guided by pulse pressure variation and stroke volume.
MAIN OUTCOME MEASURES


Changes in sDO2I and mDO2I. Secondary outcomes were changes in other haemodynamic variables, fluid balance, blood transfusions, fluid-related complications and length of stay (LOS) in ICU and hospital.
RESULTS


Median [IQR] sDO2I was 522 [420 to 665] ml min m in the ringer acetate group and 490 [363 to 676] ml min m in the human albumin group, P = 0.36. Median [IQR] mDO2I was 12.1 [5.8 to 28.7] ml min m in the ringer acetate group and 17.0 [7.6 to 27.5] ml min m in the human albumin group, P = 0.17. Other haemodynamic comparisons did not differ significantly. More trial fluid was administered in the ringer acetate group. We found no significant difference in transfusions, complications or LOS.
CONCLUSION


Bolus human albumin 5% was not superior to bolus ringer acetate in maintaining systemic or mesenteric oxygen delivery in elective major upper gastrointestinal cancer surgery, despite the administration of larger volumes of trial fluid in the ringer acetate group. No significant difference was seen in fluid-related complications or LOS.
TRIAL REGISTRATION


https://eudract.ema.europa.eu/ Identifier: 2013-002217-36.",2020,"Bolus human albumin 5% was not superior to bolus ringer acetate in maintaining systemic or mesenteric oxygen delivery in elective major upper gastrointestinal cancer surgery, despite the administration of larger volumes of trial fluid in the ringer acetate group.","['major upper abdominal surgery', 'elective major upper gastrointestinal cancer surgery', 'A total of 89 adults scheduled for elective major upper gastrointestinal cancer surgery were randomised and data from 60 were analysed', 'Odense University Hospital, Denmark, from May 2014 to June 2015']","['Goal-directed therapy (GDT', 'ringer acetate', 'GDT', 'ml\u200amin', 'GDT with bolus ringer acetate', 'intra-operative GDT with either bolus human albumin or ringer acetate 250\u200aml, guided by pulse pressure variation and stroke volume']","['transfusions, complications or LOS', 'systemic oxygen delivery index (sDO2I) and the mesenteric oxygen delivery index (mDO2I', 'haemodynamic variables, fluid balance, blood transfusions, fluid-related complications and length of stay (LOS) in ICU and hospital', 'fluid-related complications or LOS', 'Median [IQR] mDO2I']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy (regime/therapy)'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025474', 'cui_str': 'Mesentery'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",89.0,0.321958,"Bolus human albumin 5% was not superior to bolus ringer acetate in maintaining systemic or mesenteric oxygen delivery in elective major upper gastrointestinal cancer surgery, despite the administration of larger volumes of trial fluid in the ringer acetate group.","[{'ForeName': 'Jannie', 'Initials': 'J', 'LastName': 'Bisgaard', 'Affiliation': 'From the Department of Anaesthesiology and Intensive Care, Aalborg University Hospital, Aalborg (JB), Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital (RM, LLD, AGJ), Open Patient Data Explorative Network (OPEN), Region of Southern Denmark (RM), The Centre of Health Economics Research (COHERE), University of Southern Denmark (JTL) and Department of Gastrointestinal Surgery A, Odense University Hospital, Odense, Denmark (MBM).'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Madsen', 'Affiliation': ''}, {'ForeName': 'Lene L', 'Initials': 'LL', 'LastName': 'Dybdal', 'Affiliation': ''}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': ''}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Mortensen', 'Affiliation': ''}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Jensen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001151']
633,31630816,Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial.,"AIMS


The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population.
METHODS AND RESULTS


BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE - death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p=0.48) and acute kidney injury (19.7% vs. 15.1%, p=0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p=0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p=0.03) and life-threatening bleeding both in-hospital (OR 1.50, p=0.046) and at 30-days (OR 1.50, p=0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients.
CONCLUSIONS


Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.",2019,"(OR 1.57, p = 0.03) and life-threatening bleeding both in-hospital (OR 1.50, p = 0.046) and at 30-days (OR 1.50, p = 0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients.
","['Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin', '802 patients undergoing trans-femoral TAVR to procedural anticoagulation with']","['transcatheter aortic valve replacement (TAVR', 'DM', 'TAVR', 'bivalirudin or unfractionated heparin']","['vascular and bleeding complications', 'acute kidney injury', 'Net adverse cardiovascular outcomes (NACE - death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above', 'life-threatening bleeding both in-hospital', 'DM and early mortality', 'vascular complications', 'cerebrovascular accidents', 'rates of net adverse cardiovascular events']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",802.0,0.485485,"(OR 1.57, p = 0.03) and life-threatening bleeding both in-hospital (OR 1.50, p = 0.046) and at 30-days (OR 1.50, p = 0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients.
","[{'ForeName': 'Ridhima', 'Initials': 'R', 'LastName': 'Goel', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, UMR_S, 1166, Institut de Cardiologie, Pitié Salpêtrière Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'Department of Cardiology, EA3920, University Hospital Jean Minjoz, 25000, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Division of Cardiology, CHU de Rouen, Rouen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Widder', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Helios Dr. Horst Schmidt Kliniken Wiesbaden, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Violini', 'Affiliation': 'Interventional Cardiology Unit, San Camillo Hospital, Via Circonvallazione Gianicolense, Rome, Italy.'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'Arena Pharmaceuticals Inc., Zug, Canton of Zug, Switzerland.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc., Sparta, NJ, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, United States. Electronic address: george.dangas@mountsinai.org.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.09.063']
634,32406553,Alcohol Cue-Induced Ventral Striatum Activity Predicts Subsequent Alcohol Self-Administration.,"BACKGROUND


Human laboratory paradigms are a pillar in medication development for alcohol use disorders (AUD). Neuroimaging paradigms, in which individuals are exposed to cues that elicit neural correlates of alcohol craving (e.g., mesocorticolimbic activation), are increasingly utilized to test the effects of AUD medications. Elucidation of the translational effects of these neuroimaging paradigms on human laboratory paradigms, such as self-administration, is warranted. The current study is a secondary analysis examining whether alcohol cue-induced activation in the ventral striatum is predictive of subsequent alcohol self-administration in the laboratory.
METHODS


Non-treatment-seeking heavy drinkers of East Asian descent (n = 41) completed a randomized, placebo-controlled, double-blind, crossover experiment on the effects of naltrexone on neuroimaging and human laboratory paradigms. Participants completed 5 days of study medication (or placebo); on day 4, they completed a neuroimaging alcohol taste cue-reactivity task. On the following day (day 5), participants completed a 60-minute alcohol self-administration paradigm.
RESULTS


Multilevel Cox regressions indicated a significant effect of taste cue-elicited ventral striatum activation on latency to first drink, Wald χ 2   = 2.88, p = 0.05, such that those with higher ventral striatum activation exhibited shorter latencies to consume their first drink. Similarly, ventral striatum activation was positively associated with total number of drinks consumed, F(1, 38) = 5.90, p = 0.02. These effects were significant after controlling for alcohol use severity, OPRM1 genotype, and medication. Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
CONCLUSIONS


Neuroimaging alcohol taste cue paradigms may be predictive of laboratory paradigms such as self-administration. Elucidation of the relationships among different paradigms will inform how these paradigms may be used synergistically in experimental medicine and medication development.",2020,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
",['Non-treatment-seeking heavy drinkers of East Asian descent (n\xa0=\xa041'],"['naltrexone', 'placebo']","['taste cue-elicited ventral striatum activation', 'ventral striatum activation']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",41.0,0.0517698,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes.
","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Meredith', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Donato', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burnette', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14342']
635,31976576,Low-dose-oral immunotherapy for children with wheat-induced anaphylaxis.,"BACKGROUND


Oral immunotherapy (OIT) use in patients with wheat anaphylaxis is not well studied. We assessed the efficacy of low-dose OIT for patients with wheat-induced anaphylaxis.
METHODS


Eligible subjects were aged 5-18 years with a history of wheat anaphylaxis and confirmed symptoms during oral food challenge (OFC) to 53 mg of wheat protein. After admission to the hospital for a 5-day buildup phase, patients in the OIT group gradually increased wheat ingestion to 53 mg/day and then ingested 53 mg daily at home. One year later, they underwent 53- and 400-mg OFCs after OIT cessation for 2 weeks. The historical control group was defined as patients who avoided wheat during the same period.
RESULTS


Median wheat- and ω-5 gliadin-specific immunoglobulin E (sIgE) levels were 293 and 7.5 kU A  /L, respectively, in the OIT group (16 children). No patients dropped out. Within 1 year, 88% of patients in the OIT group reached 53 mg. After 1 year, 69% and 9% patients passed the 53-mg OFC and 25% and 0% passed the 400-mg OFC in the OIT and control groups (11 children), respectively (P = .002 and 0.07, respectively). In the OIT group, wheat- and ω-5 gliadin-sIgE levels significantly decreased to 154 and 4.1 kU A  /L, respectively, at 1 year, and wheat- and ω-5 gliadin-specific IgG and IgG 4  levels significantly increased at 1 month. Anaphylaxis developed 7 times and promptly improved without adrenaline.
CONCLUSION


For patients with wheat anaphylaxis, low-dose OIT safely induces immunologic changes, achieves low-dose desensitization, and may allow for a 400 mg dose.",2020,"In the OIT group, wheat- and ω-5 gliadin-sIgE levels significantly decreased to 154 and 4.1 kU A  /L, respectively, at 1 year, and wheat- and ω-5 gliadin-specific IgG and IgG 4  levels significantly increased at 1 month.","['Eligible subjects were aged 5-18 years with a history of wheat anaphylaxis and confirmed symptoms during oral food challenge (OFC) to 53-mg of wheat protein', 'patients with wheat-induced anaphylaxis', 'children with wheat-induced anaphylaxis', 'patients with wheat anaphylaxis']",['Low-dose-oral immunotherapy'],"['Median wheat- and ω-5 gliadin-specific immunoglobulin E (sIgE) levels', 'wheat- and ω-5 gliadin-specific IgG and IgG 4  levels', 'wheat- and ω-5 gliadin-sIgE levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0017622', 'cui_str': 'Gliadin'}, {'cui': 'C0443736', 'cui_str': 'Allergen specific immunoglobulin E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1275909', 'cui_str': 'Gliadin specific immunoglobulin G'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.0572819,"In the OIT group, wheat- and ω-5 gliadin-sIgE levels significantly decreased to 154 and 4.1 kU A  /L, respectively, at 1 year, and wheat- and ω-5 gliadin-specific IgG and IgG 4  levels significantly increased at 1 month.","[{'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Nagakura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Yanagida', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Asaumi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kiyotake', 'Initials': 'K', 'LastName': 'Ogura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13220']
636,31976633,Sedentary Behaviour and Diabetes Information as a Source of Motivation to Reduce Daily Sitting Time in Office Workers: A Pilot Randomised Controlled Trial.,"BACKGROUND


Using the motivational phase of the Health Action Process Approach (HAPA), this study examined whether sedentary behaviour and diabetes information is a meaningful source of motivation to reduce daily sitting time among preintending office workers.
METHODS


Participants (N = 218) were randomised into HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions. Following treatment, purpose-built sedentary-related HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions were assessed. Only participants who had given little thought to how much time they spent sitting (preintenders) were used in subsequent analyses (n = 96).
RESULTS


Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p   2  values ≥.08). Only self-efficacy (β range = 0.39-0.50) made significant and unique contributions to work and leisure-time-related goal intentions, explaining 11-21 per cent of the response variance.
CONCLUSIONS


A brief, HAPA-based online intervention providing information regarding sedentary behaviour and diabetes risk may be an effective source of motivation.",2020,"RESULTS


Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p   2  values ≥.08).","['Office Workers', 'Participants (N\xa0=\xa0218']","['HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions', 'HAPA-based online intervention']","['HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions', 'number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies', 'goal intentions']","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",218.0,0.0560881,"RESULTS


Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p   2  values ≥.08).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12190']
637,31977104,Reaching out to big losers leads to sustained reductions in gambling over 1 year: a randomized controlled trial of brief motivational contact.,"BACKGROUND AND AIMS


A previous randomized controlled trial demonstrated that telephone- and letter-based motivational interventions with high-expenditure gamblers had significant short-term positive effects on gambling and use of responsible gambling tools. This post-trial follow-up examined outcomes in gambling expenditure over 12 months.
DESIGN


Observational study following a three-arm randomized controlled trial.
SETTING


Customers of Norsk Tipping (NT) gambling platforms, Norway.
PARTICIPANTS


A total of 1003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age and net losses. Mean age was 53.4 years; 19% were women, mean yearly loss for 2016 was 88 197 NoK. Interventions and comparator Feedback intervention by telephone, letter or a no-contact control condition.
MEASUREMENTS


Primary outcome measure was gambling theoretical loss, derived from the NT customer database. Secondary outcomes were responsible gambling customer actions and whether or not the participant was retained as an NT customer.
FINDINGS


Per-protocol analyses of triplets who received the telephone call or letter as randomly assigned (n = 596) showed a positive and sustained effect over 12 months: the telephone group showed a 30% reduction in theoretical loss (d = 0.44) and the letter group 13% (d = 0.18), both outperforming the control group with a 7% reduction (d = 0.11). The telephone condition was superior to both the letter and control conditions in per-protocol (P < 0.001) and to control condition in intention-to-treat analyses (ITT) (P < 0.001). Individuals in the telephone condition took more responsible gambling actions. The letter condition had better outcomes than the control in the ITT-only analysis (P < 0.001). More than 93% were still customers a year after the intervention.
CONCLUSIONS


Personal contact with high-expenditure gambling customers in Norway that provided individualized feedback on expenditures was associated with reduced theoretical losses and greater use of responsible gambling tools over a 12-month period, compared with no contact. Telephone intervention with customers had a larger impact than a mailed letter.",2020,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"['Customers of Norsk Tipping (NT) gambling platforms, Norway', 'Mean age 53.4 years, 19% were women, mean yearly loss for 2016 was 88,197 NoK. Interventions and comparator Feedback intervention by telephone, letter, or a no-contact control condition', '1,003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age, and net losses']","['phone and letter-based motivational interventions', 'Telephone intervention', 'motivational contact']","['responsible gambling actions', 'gambling theoretical loss, derived from the Norsk Tipping customer database', 'theoretic loss', 'responsible gambling customer actions and whether the participant was retained as a NT customer']","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}]",,0.231814,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Munck', 'Affiliation': 'Department of Education and Special Education, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14982']
638,30345658,text4peds: a randomised text-messaging trial.,"BACKGROUND


The use of cell phone text messaging in the medical field is of growing interest, but there are few data examining its value in medical education. The text4peds educational text-messaging program was created for third-year medical students preparing for the National Board of Medical Examiners (NBME) paediatric subject examination.
METHODS


A randomised, controlled trial was conducted with third-year medical students on their paediatric clerkship. Students in the intervention group received daily messages consisting of multiple-choice questions with links to online material. The control group received no text messages. The impact of the intervention was assessed by examining the participants' NBME examination scores and by participant surveys.
RESULTS


A total of 162 students participated in the study. There was no statistical difference between the two groups, with the texting group having a mean score of 77.7 and with the non-texting group having a mean score of 77.8 on the NBME. Subgroup analysis examining the effect of anticipated specialty and online material interaction also failed to find any statistically significant difference. Students reported satisfaction with the program, with 84% rating the text messages as helpful. The students rated their participation as high, with 92% saying that they looked at the messages more than 60% of the time. Among those who received text messages, 90% would recommend the program to others. There was no statistical difference between the two group CONCLUSION: A text-messaging-based educational tool had a perceived positive educational value for medical students. This study failed to show any statistically significant impact on NBME examination scores from the text-messaging intervention.",2019,"There was no statistical difference between the two groups, with the texting group having a mean score of 77.7 and with the non-texting group having a mean score of 77.8 on the NBME.","['162 students participated in the study', 'third-year medical students on their paediatric clerkship', 'medical students']","['daily messages consisting of multiple-choice questions with links to online material', 'no text messages']",['NBME examination scores'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",162.0,0.066855,"There was no statistical difference between the two groups, with the texting group having a mean score of 77.7 and with the non-texting group having a mean score of 77.8 on the NBME.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brownsworth', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kaniecki', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Broom', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri, USA.'}]",The clinical teacher,['10.1111/tct.12958']
639,31868776,Preventing Postpartum Depression With Mindful Self-Compassion Intervention: A Randomized Control Study.,"Mindfulness and self-compassion are reported to have a preventive effects on depression and anxiety disorders. In the present study, we aimed to assess the effect of mindful self-compassion intervention on preventing postpartum depression in a group of symptomatic pregnant women. Participants were screened and assigned to the intervention and control groups randomly. A 6-week Internet-based Mindful Self-Compassion Program was used to train the participants. Multiple scales were used to assess depressive and anxiety symptoms, mindfulness, self-compassion, and mother and infant well-being. All assessments were performed at three time points: baseline, 3 months, and 1 year postpartum. Compared with the control group, the intervention group showed significant improvement in depressive and anxiety behaviors. In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum. More importantly, both mothers and infants experienced substantial improvement in well-being. Our findings indicate that mindful self-compassion intervention is effective in preventing postpartum depression and promoting mother and infant well-being.",2020,"In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum.",['symptomatic pregnant women'],"['Internet-based Mindful Self-Compassion Program', 'Mindful Self-Compassion Intervention', 'mindful self-compassion intervention']","['postpartum depression', 'depressive and anxiety symptoms, mindfulness, self-compassion, and mother and infant well-being', 'mindful and self-compassionate', 'depressive and anxiety behaviors']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021287', 'cui_str': 'Infant Well-Being'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0275551,"In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics and Gynecology, Tianjin First Center Hospital, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001096']
640,31973838,"Re: Hutnik et al.: Selective laser trabeculoplasty versus argon laser trabeculoplasty in glaucoma patients treated previously with 360° selective laser trabeculoplasty: a randomized, single-blind, equivalence clinical trial (Ophthalmology. 2019;126:223-232).",,2020,,['glaucoma patients treated previously with 360°'],"['laser trabeculoplasty versus argon laser trabeculoplasty', 'selective laser trabeculoplasty']",[],"[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0395482', 'cui_str': 'LTP - laser trabeculoplasty'}, {'cui': 'C1319234', 'cui_str': 'Argon laser trabeculoplasty'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]",[],,0.0409616,,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Realini', 'Affiliation': 'West Virginia University, Morgantown, West Virginia. Electronic address: realinia@wvuhealthcare.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.10.012']
641,29752632,Care Management Intervention to Decrease Psychiatric and Substance Use Disorder Readmissions in Medicaid-Enrolled Adults.,"This study examines the generalizability of a successful care management bridging strategy implemented by a behavioral health managed care organization to reduce readmission in psychiatric and substance use disorder (SUD) populations. The sample included 1724 individuals with a psychiatric or SUD hospitalization or detoxification service within 30-days of a prior SUD or inpatient event; 1243 Medicaid-enrolled adults received the intervention plus usual care, and 481 individuals received only usual care. Results included lower readmission to SUD facilities (p = .0012) and reduced odds of readmission among individuals with a SUD event (OR = 0.49, p = .0006) for the intervention versus the comparison group. Likelihood of readmission was higher for those with dual diagnoses (OR = 1.72, p = .0002) or in urban settings (OR = 1.47, p = .0010), with some evidence of the intervention's success in these populations. Care management bridging strategies may be more effective for individuals who utilize SUD services and others who need help navigating complex systems of care.",2019,"Likelihood of readmission was higher for those with dual diagnoses (OR = 1.72, p = .0002) or in urban settings (OR = 1.47, p = ","['psychiatric and substance use disorder (SUD) populations', 'Medicaid-Enrolled Adults', 'individuals who utilize SUD services and others who need help navigating complex systems of care', '1724 individuals with a psychiatric or SUD hospitalization or detoxification service within 30-days of a prior SUD or inpatient event; 1243 Medicaid-enrolled adults received the']","['intervention plus usual care, and 481 individuals received only usual care', 'Care Management Intervention']","['Likelihood of readmission', 'lower readmission to SUD facilities', 'reduced odds of readmission']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",1724.0,0.0307332,"Likelihood of readmission was higher for those with dual diagnoses (OR = 1.72, p = .0002) or in urban settings (OR = 1.47, p = ","[{'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Hutchison', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA. hutchisons@ccbh.com.'}, {'ForeName': 'Jenny V', 'Initials': 'JV', 'LastName': 'Flanagan', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Karpov', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Elliott', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Holsinger', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loveland', 'Affiliation': 'Community Care Behavioral Health Organization, 339 Sixth Avenue, Suite 1300, Pittsburgh, PA, 15222, USA.'}]",The journal of behavioral health services & research,['10.1007/s11414-018-9614-y']
642,29366724,Effects of Community-Based Exercise in Adults With Severe Burns: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the efficacy of community-based exercise programs in the rehabilitation of adult patients with burns compared with standard of care (SOC).
DESIGN


Randomized controlled trial, with 2:1 randomization.
SETTING


Assessments were performed in a hospital setting. The intervention was performed in a community setting.
PARTICIPANTS


Adult patients (N=45) with ≥30% total body surface area burns were randomized to participate in a community-based exercise program (n=31) or SOC (n=14). Patient sampling was consecutive and referred.
INTERVENTIONS


The community-based exercise program consisted of 12 weeks of exercise with a community-based trainer after hospital discharge. The SOC group did not receive exercise training.
MAIN OUTCOME MEASURES


Change in lean body mass index, peak torque, and peak oxygen consumption from discharge to 12 weeks postdischarge, presented as mean ± SE.
RESULTS


The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236). The community-based exercise program group exhibited a significant within group increase in lean body mass index (Δ=1.107±0.431kg/m 2 , P=.0003; SOC: Δ=1.323±0.873kg/m 2 , P=.2808). Both groups showed significant within-group increases in peak torque (community-based exercise program: Δ=35.645±7.566Nm, P=.0003; SOC: Δ=34.717±11.029Nm, P=.0082). No significant differences were noted between the 2 groups for lean body mass index or peak torque.
CONCLUSIONS


Patients who participate in a community-based exercise program show significant improvements in cardiopulmonary fitness compared with SOC, supporting the use of a community-based exercise program as an alternative therapy to SOC in adults with severe burns.",2020,"The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236).","['Adult patients (N=45) with ≥30% total body surface area burns', 'adults with severe burns', 'adult patients with burns compared with standard of care (SOC', 'Adults With Severe Burns']","['exercise training', 'community-based exercise program (n=31) or SOC', 'community-based exercise program', 'exercise with a community-based trainer', 'community-based exercise programs', 'Community-Based Exercise']","['lean body mass index, peak torque, and peak oxygen consumption from discharge to 12 weeks postdischarge, presented as mean ± SE', 'peak torque', 'lean body mass index or peak torque', 'peak oxygen consumption', 'cardiopulmonary fitness', 'lean body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",45.0,0.0480262,"The community-based exercise program group showed a significant increase in peak oxygen consumption compared with SOC (community-based exercise program: Δ=7.723±1.522mL/kg/min, P=.0006; SOC: Δ=2.200±1.150mL/kg/min, P=.0765; community-based exercise program vs SOC, P=.0236).","[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Voigt', 'Affiliation': 'Department of Surgery, Creighton University, Omaha, NE.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Foncerrada', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Peña', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Guillory', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Andersen', 'Affiliation': 'Department of Preventative Medicine and Community Health, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Wolf', 'Affiliation': 'Division of Burns, Trauma, and Critical Care, Department of Surgery, University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Herndon', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX.'}, {'ForeName': 'Oscar E', 'Initials': 'OE', 'LastName': 'Suman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX; Shriners Hospitals for Children, Galveston, TX. Electronic address: oesuman@utmb.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2017.12.022']
643,31983368,Telehealth Delivery of Memory Rehabilitation Following Stroke.,"OBJECTIVE


Rehabilitation of memory after stroke remains an unmet need. Telehealth delivery may overcome barriers to accessing rehabilitation services.
METHOD


We conducted a non-randomized intervention trial to investigate feasibility and effectiveness of individual telehealth (internet videoconferencing) and face-to-face delivery methods for a six-week compensatory memory rehabilitation program. Supplementary analyses investigated non-inferiority to an existing group-based intervention, and the role of booster sessions in maintaining functional gains. The primary outcome measure was functional attainment of participants' goals. Secondary measures included subjective reports of lapses in everyday memory and prospective memory, reported use of internal and external memory strategies, and objective measures of memory functioning.
RESULTS


Forty-six stroke survivors were allocated to telehealth and face-to-face intervention delivery conditions. Feasibility of delivery methods was supported, and participants in both conditions demonstrated treatment-related improvements in goal attainment, and key subjective outcomes of everyday memory, and prospective memory. Gains on these measures were maintained at six-week follow-up. Short-term gains in use of internal strategies were also seen. Non-inferiority to group-based delivery was established only on the primary measure for the telehealth delivery condition. Booster sessions were associated with greater maintenance of gains on subjective measures of everyday memory and prospective memory.
CONCLUSIONS


This exploratory study supports the feasibility and potential effectiveness of telehealth options for remote delivery of compensatory memory skills training after a stroke. These results are also encouraging of a role for booster sessions in prolonging functional gains over time.",2020,"Feasibility of delivery methods was supported, and participants in both conditions demonstrated treatment-related improvements in goal attainment, and key subjective outcomes of everyday memory, and prospective memory.",['Forty-six stroke survivors'],"['individual telehealth (internet videoconferencing', 'Memory Rehabilitation']","['subjective measures of everyday memory and prospective memory', 'subjective reports of lapses in everyday memory and prospective memory, reported use of internal and external memory strategies, and objective measures of memory functioning', ""functional attainment of participants' goals"", 'goal attainment, and key subjective outcomes of everyday memory, and prospective memory']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0589154', 'cui_str': 'Memory, Prospective'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0184422,"Feasibility of delivery methods was supported, and participants in both conditions demonstrated treatment-related improvements in goal attainment, and key subjective outcomes of everyday memory, and prospective memory.","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lawson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Renerus J', 'Initials': 'RJ', 'LastName': 'Stolwyk', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Ponsford', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Dean P', 'Initials': 'DP', 'LastName': 'McKenzie', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Epworth HealthCare, Melbourne, Australia.'}, {'ForeName': 'Marina G', 'Initials': 'MG', 'LastName': 'Downing', 'Affiliation': 'Monash-Epworth Rehabilitation Research Centre, Epworth HealthCare, Melbourne, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000651']
644,31983575,"Effect of 5-lipoxygenase inhibitor, VIA-2291 (Atreleuton), on epicardial fat volume in patients with recent acute coronary syndrome.","BACKGROUND AND AIMS


The association between inflammation and atherosclerosis has been well described in the literature. There is now mounting evidence in support of adipose tissue as a reservoir for inflammatory markers. Epicardial adipose tissue (EAT) has been shown to associate with coronary atherosclerosis and found to be a predictor of future adverse cardiovascular events. This study, VIA-EAT, assesses the change in epicardial fat volume (EFV) after treatment with an investigational anti-inflammatory agent (VIA-2291) in a cohort of post-acute coronary syndrome (ACS) patients.
METHODS


This study is derived from a post-hoc analysis of a previously conducted randomized clinical trial (NCT00358826). Patients were recruited for a prospective, double-blind, multi-center randomized trial of a 5-lipooxygenase inhibitor or placebo in a 3:1 randomization, including doses of placebo, and 25 mg, 50 mg and 100 mg of active treatment. Cardiac computed tomography was performed at baseline and at 24 weeks after treatment with VIA-2291. EAT and pericardial adipose tissue (PAT) were measured using previously published methodology. A Pearson correlation test was used to determine the relationship between change in epicardial fat and change in plaque composition.
RESULTS


We analyzed 54 pre- and post-treatment scans. There were no major differences between traditional cardiovascular risk factors among the 4 randomized study arms. There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± 7.5mm3 and 1.4 ± 10.7mm3 (p = 0.001), respectively. The changes in EAT and PAT were more pronounced in patients taking 100 mg of the drug vs. placebo: 4.2 ± 9.6mm3, -7.6 ± 8.5mm3, p = 0.0001, respectively. In a subgroup analysis, reduction in epicardial fat volume correlated with reduction in total atherosclerotic plaque volume across all VIA treatment groups, r = 0.52 (p = 0.004).
CONCLUSIONS


After adjustment for traditional cardiovascular risk factors including age, gender, body mass index, dyslipidemia and smoking, VIA-2291 decreases EAT and PAT in individuals with recent ACS. Treatment with the drug also appears to alter plaque volume and composition.",2020,"There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± ","['patients with recent acute coronary syndrome', 'cohort of post-acute coronary syndrome (ACS) patients']","['placebo, and 25\xa0mg, 50\xa0mg and 100\xa0mg of active treatment', 'investigational anti-inflammatory agent (VIA-2291', '5-lipooxygenase inhibitor or placebo', '5-lipoxygenase inhibitor, VIA-2291 (Atreleuton', 'placebo', 'Epicardial adipose tissue (EAT']","['epicardial fat volume', 'EAT and pericardial adipose tissue (PAT', 'epicardial fat and change in plaque composition', 'plaque volume and composition', 'EAT and PAT', 'epicardial fat volume (EFV', 'reduction in epicardial fat volume', 'total atherosclerotic plaque volume', 'traditional cardiovascular risk factors', 'changes in EAT and PAT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}, {'cui': 'C2930557', 'cui_str': 'VIA 2291'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1289971', 'cui_str': 'Arachidonate 5-Lipoxygenase Inhibitors'}, {'cui': 'C0384233', 'cui_str': 'atreleuton'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2936350', 'cui_str': 'Plaque, Atherosclerotic'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.430691,"There was a significant decrease in EAT and PAT in patients in the treatment arms vs. placebo, -3.0 ± 8.2mm3 and -3.9 ± 10.9mm3 vs. 1.7 ± ","[{'ForeName': 'Shone O', 'Initials': 'SO', 'LastName': 'Almeida', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA. Electronic address: Shonealmeida@gmail.com.'}, {'ForeName': 'Reuben J', 'Initials': 'RJ', 'LastName': 'Ram', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St, Torrance, CA, 90502, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.12.033']
645,31973934,Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial.,"INTRODUCTION


Coolant spray application in musculoskeletal injuries is an effective and harmless method to treat pain and reduce functional limitation. This study assessed the clinical value of coolant spray application on patient comfort before and during the radiographic imaging process along with its early analgesic and anti-edema effects.
METHODS


A total of 155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study. The patients were randomly assigned to either a coolant spray or a saline spray (placebo) group. To the coolant spray group patients, Cryos ®Spray (Phyto Performance, Italy) was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 °C was sprayed. Radiographic images of the patients were scored for appropriateness of the standard imaging characteristics.
RESULTS


The mean scores were 8.13 ± 1.8 and 6.58 ± 2.2 for the coolant spray and normal saline spray groups, respectively; the differences were statistically significant between the two groups (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000). Patients with fractures on their radiographs and treated with coolant spray received higher scores than similar patients treated with normal saline spray (mean difference:-1.92, 95% CI:-3.28 to -0.55; p = .009). The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
CONCLUSIONS


The radiographic images taken after coolant spray intervention in patients with acute ankle trauma were more successful in showing the target structures.",2020,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","['155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study', 'patients with acute ankle trauma']","['coolant spray or a saline spray (placebo', 'placebo', 'normal saline solution', 'normal saline spray', 'coolant spray']","['proportion of patients requesting analgesic treatment before discharge', 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.112359,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).
","[{'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: sultantuna@hotmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Kutsi', 'Initials': 'K', 'LastName': 'Tuncer', 'Affiliation': 'Orthopedics and Traumatology, Department of Orthopedics and Traumatology, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Karabulut', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.12.054']
646,31625483,Computer-based tailored dietary counselling improves the nutrient adequacy of the diet of French pregnant women: a randomised controlled trial.,"During pregnancy, mothers-to-be should adapt their diet to meet increases in nutrient requirements. Pregnant women appear to be keener to adopt healthier diets, but are not always successful. The objective of the present study was to determine whether a guided, stepwise and tailored dietary counselling programme, designed using an optimisation algorithm, could improve the nutrient adequacy of the diet of pregnant women, beyond generic guidelines. Pregnant women (n 80) who attended Notre-Dame-de-Bon-Secours Maternity Clinic were randomly allocated to the control or intervention arm. Dietary data were obtained twice from an online 3-d dietary record. The nutrient adequacy of the diet was calculated using the PANDiet score, a 100-point diet quality index adapted to the specific nutrient requirements for pregnancy. Women were supplied with generic dietary guidelines in a reference booklet. In the intervention arm, they also received nine sets of tailored dietary advice identified by an optimisation algorithm as best improving their PANDiet score. Pregnant women (n 78) completed the 12-week dietary follow-up. Initial PANDiet scores were similar in the control and intervention arms (60·4 (sd 7·3) v. 60·3 (sd 7·3), P = 0·92). The PANDiet score increased in the intervention arm (+3·6 (sd 9·3), P = 0·02) but not in the control arm (-0·3 (sd 7·3), P = 0·77), and these changes differed between arms (P = 0·04). In the intervention arm, there were improvements in the probabilities of adequacy for α-linolenic acid, thiamin, folate and cholesterol intakes (P < 0·05). Tailored dietary counselling using a computer-based algorithm is more effective than generic dietary counselling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.",2020,"In the intervention arm, there were improvements in the probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes (P<0.05).Tailored dietary counseling using a computer-based algorithm is more effective than generic dietary counseling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.","['French pregnant women', 'Pregnant women', 'pregnant women, beyond generic guidelines.80 pregnant women who attended Notre-Dame-de-Bon-Secours Maternity Clinic']","['nine sets of tailored dietary advice identified by an optimization algorithm', 'Computer-based tailored dietary counseling', 'guided, stepwise and tailored dietary counseling program']","['PANDiet score', 'probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes', 'Initial PANDiet scores']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0112088', 'cui_str': 'DAME'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}]","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0574956,"In the intervention arm, there were improvements in the probabilities of adequacy for ALA, thiamin, folate and cholesterol intakes (P<0.05).Tailored dietary counseling using a computer-based algorithm is more effective than generic dietary counseling alone in improving the nutrient adequacy of the diet of French women in mid-pregnancy.","[{'ForeName': 'Clélia M', 'Initials': 'CM', 'LastName': 'Bianchi', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mariotti', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Global Nutrition Department, Danone Nutricia Research, Centre Daniel Carasso, RD 128, 91737 Palaiseau Cedex, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Journet', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Yaëlle', 'Initials': 'Y', 'LastName': 'Stehr', 'Affiliation': 'Notre Dame de Bon Secours Maternity Unit, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Beaussier', 'Affiliation': 'Clinical Research Center, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Fournier', 'Affiliation': 'Clinical Research Center, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dervaux', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Cohen-Tanuggi', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Reulet', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Verger', 'Affiliation': 'NUTRIPASS, IRD, Université de Montpellier, SupAgro, 34000 Montpellier, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Azria', 'Affiliation': 'Notre Dame de Bon Secours Maternity Unit, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Huneau', 'Affiliation': 'UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005 Paris, France.'}]",The British journal of nutrition,['10.1017/S0007114519002617']
647,31969687,Co-development of a physiotherapist-delivered physical activity intervention for adults with spinal cord injury.,"STUDY DESIGNS


Cross-sectional survey, semi-structured interview, and randomized-controlled trial.
OBJECTIVES


Optimal spinal cord injury (SCI)-specific PA intervention strategies appropriate for the physiotherapist setting are unknown. The purpose of this paper is to describe the rigorous co-development process of a theory-based, physiotherapist-led PA intervention for people with SCI and assess its feasibility for implementation in the rehabilitation setting.
SETTING


Community.
METHODS


Co-development of the intervention included (1) a review of the literature; (2) key informant interviews with people with SCI (n = 26); (3) a national online survey of physiotherapists' barriers, needs, and preferences (n = 239); (4) a review of the evidence and recommendations for the intervention from a stakeholder expert panel (n = 13); and (5) a randomized controlled trial of intervention training and its effects on implementation determinants amongst physiotherapists (n = 20).
RESULTS


Almost 300 people with SCI and physiotherapists were engaged in the intervention development process. Optimal intervention delivery should be tailored and include (1) education on safety, PA guidelines, and behaviour change techniques, (2) referral to other peers, local programmes, and health professionals, and (3) adapted exercise prescriptions. Following intervention implementation training, physiotherapists demonstrated stronger tested and perceived knowledge, skills, resources, and confidence for promoting PA to people with SCI, ps < 0.05.
CONCLUSIONS


This development process serves as an example methodology for using theory to co-create a leisure-time physical activity behaviour change intervention tailored for people with SCI.",2020,"Following intervention implementation training, physiotherapists demonstrated stronger tested and perceived knowledge, skills, resources, and confidence for promoting PA to people with SCI, ps < 0.05.
","[""Co-development of the intervention included (1) a review of the literature; (2) key informant interviews with people with SCI (n\u2009=\u200926); (3) a national online survey of physiotherapists' barriers, needs, and preferences (n\u2009=\u2009239); (4"", '300 people with SCI and physiotherapists', 'people with SCI', 'adults with spinal cord injury', 'Community']","['physiotherapist-led PA intervention', 'physiotherapist-delivered physical activity intervention', 'intervention training']",[],"[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.107125,"Following intervention implementation training, physiotherapists demonstrated stronger tested and perceived knowledge, skills, resources, and confidence for promoting PA to people with SCI, ps < 0.05.
","[{'ForeName': 'Jasmin K', 'Initials': 'JK', 'LastName': 'Ma', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada. Jasmin.ma@ubc.ca.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Cheifetz', 'Affiliation': 'Hematology/Oncology Program, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Chebaro', 'Affiliation': 'Neurocore Physiotherapy & Pilates Centre, Richmond Hill, ON, Canada.'}, {'ForeName': 'Sen Hoong', 'Initials': 'SH', 'LastName': 'Phang', 'Affiliation': 'Propel Physiotherapy, Toronto, ON, Canada.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Shaw', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Whaley', 'Affiliation': 'Propel Physiotherapy, Toronto, ON, Canada.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0422-x']
648,31983371,Impact of Combined Transcranial Direct Current Stimulation and Speech-language Therapy on Spontaneous Speech in Aphasia: A Randomized Controlled Double-blind Study.,"OBJECTIVE


Aphasia recovery depends on neural reorganization, which can be enhanced by speech-language therapy and noninvasive brain stimulation. Several studies suggested that transcranial direct current stimulation (tDCS) associated with speech-language therapy may improve verbal performance evaluated by analytic tests, but none focused on spontaneous speech. We explored the effect of bihemispheric tDCS on spontaneous speech in patients with poststroke aphasia.
METHODS


In this multicentric controlled randomized cross-over double-blind study, we included 10 patients with poststroke aphasia (4 had aphasia >6 months and 6 with aphasia <6 months). We combined the sessions of speech-language therapy and bihemispheric tDCS (2 mA, 20 min). After three baseline speech evaluations (1/week), two different conditions were randomly consecutively proposed: active and sham tDCS over 3 weeks with 1 week of washout in between. The main outcome measure was the number of different nouns used in 2 min to answer the question ""what is your job.""
RESULTS


There was no significant difference between conditions concerning the main outcome measure (p = .47) nor in the number of verbs, adjectives, adverbs, pronouns, repetitions, blank ideas, ideas, utterances with grammatical errors or paraphasias used. Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group. No adverse events occurred.
CONCLUSION


Our results differed from previous studies using tDCS to improve naming in patients with poststroke aphasia possibly due to bihemispheric stimulation, rarely used previously. The duration of the rehabilitation period was short given the linguistic complexity of the measure. This negative result should be confirmed by larger studies with ecological measures.",2020,"Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group.","['10 patients with poststroke aphasia (4 had aphasia >6\xa0months and 6 with aphasia', 'Spontaneous Speech in Aphasia', 'patients with poststroke aphasia']","['speech-language therapy and bihemispheric tDCS', 'tDCS', 'bihemispheric tDCS', 'transcranial direct current stimulation (tDCS', 'active and sham tDCS', 'Combined Transcranial Direct Current Stimulation and Speech-language Therapy']","['number of verbs, adjectives, adverbs, pronouns, repetitions, blank ideas, ideas, utterances with grammatical errors or paraphasias used', 'spontaneous speech', 'cognitive functions (verbal working memory, neglect, or verbal fluency', 'adverse events', 'verbal performance', 'number of different nouns used in 2\xa0min to answer the question ""what is your job']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0234488', 'cui_str': 'Paraphasia (finding)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]",10.0,0.137263,"Other cognitive functions (verbal working memory, neglect, or verbal fluency) were not significantly improved in the tDCS group.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Guillouët', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Cogné', 'Affiliation': 'Rehabilitation Unit, University Hospital, Rennes 35000, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Saverot', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pradat-Diehl', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Weill-Chounlamountry', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ramel', 'Affiliation': 'Rehabilitation Unit, hôpital Pitié-Salpêtrière, AP-HP, Paris 75013, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Taratte', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Anne-Gaëlle', 'Initials': 'AG', 'LastName': 'Lachasse', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Jean-Arthur', 'Initials': 'JA', 'LastName': 'Haulot', 'Affiliation': 'Rehabilitation Unit, MGEN, Maisons-Laffitte 78600, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vaugier', 'Affiliation': ""Inserm, Centre d'Investigation Clinique 1429, AP-HP, Raymond Poincaré hospital, Garches 92380, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Barbot', 'Affiliation': ""Inserm, Centre d'Investigation Clinique 1429, AP-HP, Raymond Poincaré hospital, Garches 92380, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Azouvi', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Charveriat', 'Affiliation': 'Rehabilitation Unit, Raymond Poincaré Hospital, Garches 92380, France.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719001036']
649,31951305,A pilot study of the effects of a high-intensity aerobic exercise session on heart rate variability and arterial compliance in adolescents with or without type 1 diabetes.,"Arterial compliance and autonomic regulation are predictors of cardiovascular disease. In adults, both are altered chronically by type 1 diabetes (T1D) and acutely by exercise; however, the effects of T1D and exercise are less clear in adolescents. We measured short-term effects of a high-intensity aerobic interval exercise session on cardiovascular and metabolic variables in normal weight adolescents with T1D or without T1D (Control). Energy expenditure (EE), heart rate variability (HRV), arterial compliance, and blood pressure (BP) were measured before exercise (baseline) and three times over 105 minutes postexercise. The T1D and control groups had similar cardiorespiratory fitness and accelerometer-measured physical activity. The T1D group had higher EE and fat oxidation throughout the trial, but postexercise changes were similar between groups. HRV transiently declined following exercise in both groups, but the T1D group had lower HRV at baseline. Among the measures of arterial compliance, the augmentation index declined postexercise while carotid-femoral pulse wave velocity and large artery elastic index remained unchanged. Central and brachial BP were unchanged following exercise until the final measurement, when a small increase occurred. However, arterial compliance and BP did not differ between groups. These results demonstrate that normal weight adolescents with T1D have impaired autonomic function and increased EE and fat oxidation compared to peers without diabetes who have similar levels of fitness and physical activity. However, acute cardiometabolic responses to exercise are normal in T1D with adequate glycemic control. Changes in arterial compliance and BP may take longer to emerge in relatively healthy adolescents with T1D.",2020,"The T1D group had higher EE and fat oxidation throughout the trial, but postexercise changes were similar between groups.","['adolescents with or without type 1 diabetes', 'normal weight adolescents with T1D or without T1D (Control', 'healthy adolescents with T1D']","['high-intensity aerobic interval exercise session', 'high-intensity aerobic exercise session']","['HRV', 'arterial compliance and BP', 'Energy expenditure (EE), heart rate variability (HRV), arterial compliance, and blood pressure (BP', 'autonomic function and increased EE and fat oxidation', 'higher EE and fat oxidation', 'heart rate variability and arterial compliance', 'Central and brachial BP', 'arterial compliance, the augmentation index declined postexercise while carotid-femoral pulse wave velocity and large artery elastic index', 'cardiovascular and metabolic variables', 'cardiorespiratory fitness and accelerometer-measured physical activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0675464,"The T1D group had higher EE and fat oxidation throughout the trial, but postexercise changes were similar between groups.","[{'ForeName': 'Shai Konnar D', 'Initials': 'SKD', 'LastName': 'Ansell', 'Affiliation': 'Section of Diabetes & Endocrinology, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jester', 'Affiliation': 'College of Nursing, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'Section of Diabetes & Endocrinology, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Short', 'Affiliation': 'Section of Diabetes & Endocrinology, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",Pediatric diabetes,['10.1111/pedi.12983']
650,31337325,Behavioral Activation as a Treatment for Posttraumatic Stress Disorder Among Returning Veterans: A Randomized Trial.,"OBJECTIVE


Although evidence-based, trauma-processing treatments exist for posttraumatic stress disorder (PTSD), many individuals do not seek out, complete, or fully respond to these treatments, pointing to the need for alternative treatments. In this study, the authors evaluated the effectiveness of behavioral activation therapy modified to address PTSD among veterans.
METHODS


In a randomized trial, behavioral activation was compared with treatment as usual (referral to PTSD ""standard care"") among a sample of 80 veterans of the wars in Iraq and Afghanistan who were enrolled at the U.S. Department of Veterans Affairs (VA) Portland Health Care System and the VA Puget Sound Health Care System.
RESULTS


Levels of PTSD symptoms decreased for both groups across posttreatment and at 3-month follow-up as measured by clinical interview and self-report measures. The behavioral activation group had greater improvement on PTSD as evidenced by the self-report measure of symptom severity. Both groups also showed improvement on self-report measures of depression and overall functioning across time, with greater improvement on depression evidenced by the behavioral activation group. Ratings of treatment satisfaction were high for both groups.
CONCLUSIONS


Behavioral activation is a promising alternative treatment for PTSD.",2019,"Both groups also showed improvement on self-report measures of depression and overall functioning across time, with greater improvement on depression evidenced by the behavioral activation group.","['veterans', 'Posttraumatic Stress Disorder Among Returning Veterans', '80 veterans of the wars in Iraq and Afghanistan who were enrolled at the U.S. Department of Veterans Affairs (VA) Portland Health Care System and the VA Puget Sound Health Care System']","['behavioral activation therapy', 'Behavioral Activation']","['Ratings of treatment satisfaction', 'PTSD', 'PTSD symptoms', 'depression', 'self-report measures of depression and overall functioning across time']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy (regime/therapy)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",80.0,0.0116226,"Both groups also showed improvement on self-report measures of depression and overall functioning across time, with greater improvement on depression evidenced by the behavioral activation group.","[{'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Wagner', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Portland Health Care System, Portland, Oregon (Wagner, Kowalski); Department of Psychiatry, Oregon Health and Science University, Portland (Wagner); VA National Telemental Health Hub, Continental Region, Salt Lake City (Jakupcak); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Jakupcak); Department of Psychiatry, University of California, San Diego, La Jolla (Golshan). Dr. Bittinger, who was with the VA Puget Sound Health Care System, is now deceased.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jakupcak', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Portland Health Care System, Portland, Oregon (Wagner, Kowalski); Department of Psychiatry, Oregon Health and Science University, Portland (Wagner); VA National Telemental Health Hub, Continental Region, Salt Lake City (Jakupcak); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Jakupcak); Department of Psychiatry, University of California, San Diego, La Jolla (Golshan). Dr. Bittinger, who was with the VA Puget Sound Health Care System, is now deceased.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Kowalski', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Portland Health Care System, Portland, Oregon (Wagner, Kowalski); Department of Psychiatry, Oregon Health and Science University, Portland (Wagner); VA National Telemental Health Hub, Continental Region, Salt Lake City (Jakupcak); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Jakupcak); Department of Psychiatry, University of California, San Diego, La Jolla (Golshan). Dr. Bittinger, who was with the VA Puget Sound Health Care System, is now deceased.'}, {'ForeName': 'Joyce N', 'Initials': 'JN', 'LastName': 'Bittinger', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Portland Health Care System, Portland, Oregon (Wagner, Kowalski); Department of Psychiatry, Oregon Health and Science University, Portland (Wagner); VA National Telemental Health Hub, Continental Region, Salt Lake City (Jakupcak); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Jakupcak); Department of Psychiatry, University of California, San Diego, La Jolla (Golshan). Dr. Bittinger, who was with the VA Puget Sound Health Care System, is now deceased.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Golshan', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) Portland Health Care System, Portland, Oregon (Wagner, Kowalski); Department of Psychiatry, Oregon Health and Science University, Portland (Wagner); VA National Telemental Health Hub, Continental Region, Salt Lake City (Jakupcak); Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Jakupcak); Department of Psychiatry, University of California, San Diego, La Jolla (Golshan). Dr. Bittinger, who was with the VA Puget Sound Health Care System, is now deceased.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800572']
651,31658923,Psychological Symptoms and Rates of Performance Validity Improve Following Trauma-Focused Treatment in Veterans with PTSD and History of Mild-to-Moderate TBI.,"OBJECTIVE


Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) history have high rates of performance validity test (PVT) failure. The study aimed to determine whether those with scores in the invalid versus valid range on PVTs show similar benefit from psychotherapy and if psychotherapy improves PVT performance.
METHOD


Veterans (N = 100) with PTSD, mild-to-moderate TBI history, and cognitive complaints underwent neuropsychological testing at baseline, post-treatment, and 3-month post-treatment. Veterans were randomly assigned to cognitive processing therapy (CPT) or a novel hybrid intervention integrating CPT with TBI psychoeducation and cognitive rehabilitation strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART). Performance below standard cutoffs on any PVT trial across three different PVT measures was considered invalid (PVT-Fail), whereas performance above cutoffs on all measures was considered valid (PVT-Pass).
RESULTS


Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group. Measures of post-concussive and depressive symptoms improved to a similar degree across groups. Treatment condition did not moderate these results. Rate of valid test performance increased from baseline to follow-up across conditions, with a stronger effect in the SMART-CPT compared to CPT condition.
CONCLUSION


Both PVT groups experienced improved psychological symptoms following treatment. Veterans who failed PVTs at baseline demonstrated better test engagement following treatment, resulting in higher rates of valid PVTs at follow-up. Veterans with invalid PVTs should be enrolled in trauma-focused treatment and may benefit from neuropsychological assessment after, rather than before, treatment.",2020,"Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group.","['Veterans with PTSD and History of Mild-to-Moderate TBI', 'Veterans with invalid PVTs', 'Veterans (N = 100) with PTSD, mild-to-moderate TBI history, and cognitive complaints underwent neuropsychological testing at baseline, post-treatment, and 3-month post-treatment', 'Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) and traumatic brain injury']","['PVT', 'cognitive processing therapy (CPT) or a novel hybrid intervention integrating CPT with TBI psychoeducation and cognitive rehabilitation strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART']","['Measures of post-concussive and depressive symptoms', 'PVT performance', 'symptom reduction', 'performance validity test (PVT) failure', 'PTSD symptoms', 'Rate of valid test performance', 'psychological symptoms', 'Psychological Symptoms and Rates of Performance Validity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231173', 'cui_str': 'Invalidism (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",,0.0222698,"Although both PVT groups exhibited clinically significant improvement in PTSD symptoms, the PVT-Pass group demonstrated greater symptom reduction than the PVT-Fail group.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jurick', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Crocker', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Merritt', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hoffman', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Amber V', 'Initials': 'AV', 'LastName': 'Keller', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Graham M L', 'Initials': 'GML', 'LastName': 'Eglit', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Kelsey R', 'Initials': 'KR', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Schiehser', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Carie S', 'Initials': 'CS', 'LastName': 'Rodgers', 'Affiliation': 'PsychArmor Institute, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Twamley', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Jak', 'Affiliation': 'VA San Diego Healthcare System (VASDHS), San Diego, CA, USA.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000997']
652,31554528,Randomised trial of chronic supplementation with a nutraceutical mixture in subjects with non-alcoholic fatty liver disease.,"A mixture of natural ingredients, namely, DHA, phosphatidylcholine, silymarin, choline, curcumin and d-α-tocopherol, was studied in subjects with non-alcoholic fatty liver disease (NAFLD). Primary endpoints were serum levels of hepatic enzymes, and other parameters of liver function, the metabolic syndrome and inflammation were the secondary endpoints. The coagulation-fibrinolysis balance was also thoroughly investigated, as NAFLD is associated with haemostatic alterations, which might contribute to increased cardiovascular risk of this condition. The present study involved a double-blind, randomised, multicentre controlled trial of two parallel groups. Subjects with NAFLD (18-80 years, either sex) received the active or control treatment for 3 months. All assays were performed on a total of 113 subjects before and at the end of supplementation. The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased from 23·2 to 3·7 % after treatment, only the AST levels reaching statistical significance. However, no differences were found between control and active groups. Metabolic and inflammatory variables were unchanged, except for a slight (less than 10 %) increase in cholesterol and glucose levels after the active treatment. Coagulation-fibrinolytic parameters were unaffected by either treatment. In conclusion, chronic supplementation with the mixture of dietary compounds was well tolerated and apparently safe in NAFLD subjects. The trial failed to demonstrate any efficacy on relevant physiopathological markers, but its protocol and results may be useful to design future studies with natural compounds.",2020,"The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels.","['Subjects with NAFLD (18-80 years, either sex', 'subjects with non alcoholic fatty liver disease (NAFLD', '113 total subjects', 'subjects with Non Alcoholic Fatty Liver Disease (NAFLD']","['docosahexaenoic acid (DHA), phosphatidylcholine, silymarin, choline, curcumin and D-α-tocopherol', 'nutraceutical mixture', 'chronic supplementation']","['Metabolic and inflammatory variables', 'coagulation-fibrinolysis balance', 'serum levels of hepatic enzymes; other parameters of liver function, metabolic syndrome and inflammation', 'cholesterol and glucose levels', 'Coagulation-fibrinolytic parameters', 'hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",,0.119658,"The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cerletti', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Colucci', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Storto', 'Affiliation': 'Clinical Pathology Unit, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Concetta T', 'Initials': 'CT', 'LastName': 'Ammollo', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Incampo', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Costanzo', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Bartolomeo', 'Affiliation': 'U.O. Internal Medicine, Ospedale ""F. Veneziale"", Isernia, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Portincasa', 'Affiliation': 'Clinica Medica ""A. Murri"", Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Semeraro', 'Affiliation': 'Laboratory for Haemostasis and Thrombosis, Department of Biomedical Sciences and Human Oncology, University ""Aldo Moro"", Bari, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Iacoviello', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Gaetano', 'Affiliation': 'Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy.'}]",The British journal of nutrition,['10.1017/S0007114519002484']
653,31479563,Statin use and longitudinal changes in prostate volume; results from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial.,"OBJECTIVE


To test the association between statin use and prostate volume (PV) change over time using data from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, a 4-year randomised controlled trial testing dutasteride for prostate cancer chemoprevention.
SUBJECTS/PATIENTS AND METHODS


We identified men with a baseline negative prostate biopsy from REDUCE who did not undergo prostate surgery or develop prostate cancer over the trial period. Men reported statin use at baseline. PV was determined from transrectal ultrasonography performed to guide prostate biopsy at baseline, and 2- and 4-years after randomisation. Multivariable generalised estimating equations tested differences in PV change over time by statin use, overall and stratified by treatment arm. We tested for interactions between statins and time in association with PV using the Wald test.
RESULTS


Of 4106 men, 17% used statins at baseline. Baseline PV did not differ by statin use. Relative to non-users, statin users had decreasing PVs over the trial period (P = 0.027). Similar patterns were seen in the dutasteride and placebo arms, although neither reached statistical significance. The mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, P = 0.032) and 4-years (4.0%, P = 0.033), with similar (3-3.3%) but non-significant effects in the placebo arm.
CONCLUSION


If confirmed, our present findings support a role for statins in modestly attenuating PV growth, with a magnitude of effect in line with previously reported prostate-specific antigen-lowering effects of statins (~4%). Future studies are needed to assess whether this putative role for statins in PV growth could impact lower urinary tract symptom development or progression.",2020,"Mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, p=0.032) and 4-years (4.0%, p=0.033), with similar (3-3.3%) but non-significant effects in the placebo arm.
","['men with a baseline negative prostate biopsy from REDUCE who did not undergo prostate surgery or develop prostate cancer over the trial period', 'Of 4,106 men, 17% used statins at baseline']","['dutasteride', 'dutasteride and placebo']","['Baseline PV', 'Mean estimated PV']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",4106.0,0.2211,"Mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, p=0.032) and 4-years (4.0%, p=0.033), with similar (3-3.3%) but non-significant effects in the placebo arm.
","[{'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Allott', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Csizmadi', 'Affiliation': 'Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Howard', 'Affiliation': 'Duke Cancer Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Muller', 'Affiliation': 'Division of Urology, Center of Oncologic Research (CEPON), Florianopolis, Santa Catarina, Brazil.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Moreira', 'Affiliation': 'Department of Urology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Claus G', 'Initials': 'CG', 'LastName': 'Roehrborn', 'Affiliation': 'Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",BJU international,['10.1111/bju.14905']
654,31753736,Extended release mixed amphetamine salts and topiramate for cocaine dependence: A randomized clinical replication trial with frequent users.,"BACKGROUND


Cocaine use disorder (CUD) remains a substantial public health problem with no clearly effective pharmacotherapy available. In a prior trial, combined amphetamine and topiramate treatment significantly reduced cocaine use among individuals demonstrating the most frequent use at baseline. This trial targeted such frequent users.
METHODS


A double-blind, randomized placebo-controlled trial, testing the combination of mixed amphetamine salts extended-release (MAS-ER) and topiramate or placebo over a 12-week medication phase was conducted. The two-site outpatient trial included 127 adults (96 males) with CUD using at least 9 days in the prior month. MAS-ER was titrated to a maximum dose of 60 mg/day and topiramate to a maximum dose of 100 mg twice/day. The primary outcome was the proportion of individuals who achieved three consecutive abstinent weeks at the end of the study (EOS) as measured by urine toxicology and self-report.
RESULTS


The proportion of participants achieving three abstinent weeks at the EOS was significantly (P = .03) larger in the treatment (14.1%) compared to the placebo group (0.0%), while controlling for baseline cocaine use, sex, current alcohol use disorder, and site. Of note, due to conservative cardiac safety-parameters a considerable number of individuals in the treatment group were discontinued from study medication (20.3%).
CONCLUSIONS


While these findings provide further evidence that the combination of MAS-ER and topiramate is efficacious in promoting abstinence in CUD adults with frequent use it remains possible that the combination treatment is no more effective than either treatment alone. Despite this, the study provides a valuable ""proof of concept.""",2020,"The proportion of participants achieving three abstinent weeks at the EOS was significantly (P = .03) larger in the treatment (14.1%) compared to the placebo group (0.0%), while controlling for baseline cocaine use, sex, current alcohol use disorder, and site.","['cocaine dependence', 'CUD adults with frequent use', '127 adults (96 males) with CUD using at least 9 days in the prior month']","['MAS-ER and topiramate', 'amphetamine and topiramate', 'mixed amphetamine salts extended-release (MAS-ER) and topiramate or placebo', 'placebo', 'amphetamine salts and topiramate']",['proportion of individuals who achieved three consecutive abstinent weeks at the end of the study (EOS) as measured by urine toxicology and self-report'],"[{'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042037'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",127.0,0.398107,"The proportion of participants achieving three abstinent weeks at the EOS was significantly (P = .03) larger in the treatment (14.1%) compared to the placebo group (0.0%), while controlling for baseline cocaine use, sex, current alcohol use disorder, and site.","[{'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA. Electronic address: frl2@columbia.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University, 722 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'New York State Psychiatric Institute, Division of Biostatistics, 1051 Riverside Drive, New York, NY 10032 USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Mahony', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Brooks', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Dakwar', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Carpenter', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Naqvi', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104 USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107700']
655,31753737,Methadone treatment of arrestees: A randomized clinical trial.,"BACKGROUND


Opioid use disorder is common among detainees in US jails, yet methadone treatment is rarely initiated.
METHODS


This is a three-group randomized controlled trial in which 225 detainees in Baltimore treated for opioid withdrawal were assigned to: (1) interim methadone (IM) with patient navigation (IM + PN); (2) IM; or (3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to enter standard methadone treatment upon release, while ETAU participants received an assessment/referral number. Follow-up assessments at 1, 3, 6, and 12 months post-release determined treatment enrollment, urine drug testing results, self-reported days of drug use, criminal activity, and overdose events. Generalized linear mixed modelling examined two planned contrasts: (1) IM groups combined vs. ETAU; and (2) IM + PN vs. IM.
RESULTS


On an intention-to-treat basis, compared to ETAU, significantly more participants in the combined IM groups were in treatment 30 days post-release, while the IM + PN vs. IM groups did not significantly differ. By month 12, there were no significant differences in the estimated marginal means of enrollment in any kind of drug treatment (0.40 and 0.27 for IM + PN and IM groups, respectively, compared to 0.29 for ETAU). There were no significant differences for either contrast in opioid-positive tests, although all groups reported a sharp decrease in heroin use from baseline to follow-up. There were five fatal overdoses, but none occurred during methadone treatment.
CONCLUSION


Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.",2020,Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.,['225 detainees in Baltimore treated for opioid withdrawal'],"['methadone', 'methadone (IM) with patient navigation (IM\u202f+\u202fPN); (2) IM; or (3) enhanced treatment-as-usual (ETAU', 'Methadone']","['urine drug testing results, self-reported days of drug use, criminal activity, and overdose events', 'heroin use']","[{'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0042037'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0851832', 'cui_str': 'Criminal activity'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.114502,Initiating methadone treatment in jail was effective in promoting entry into community-based drug abuse treatment but subsequent treatment discontinuation attenuated any potential impact of such treatment.,"[{'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: Rschwartz@friendsresearch.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: skelly@friendsresearch.org.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: smitchell@friendsresearch.org.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA. Electronic address: ogrady@umd.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: asharma@friendsresearch.org.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Jaffe', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: jhjaffe@aol.com.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107680']
656,31736328,Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age: Insights From DAPA-HF.,"BACKGROUND


The DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure) showed that dapagliflozin added to other guideline-recommended therapies reduced the risk of mortality and heart failure hospitalization and improved symptoms in patients with heart failure and reduced ejection fraction. We examined the effects of dapagliflozin according to age, given potential concerns about the efficacy and safety of therapies in the elderly.
METHODS


Patients in New York Heart Association functional class II or greater with a left ventricular ejection fraction ≤40% and a modest elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide) were eligible. Key exclusion criteria included systolic blood pressure <95 mm Hg and estimated glomerular filtration rate <30 mL·min -1 ·1.73 m -2 . The primary outcome was the composite of an episode of worsening heart failure (heart failure hospitalization or urgent heart failure visit) or cardiovascular death, whichever occurred first.
RESULTS


A total of 4744 patients 22 to 94 years of age (mean age, 66.3 [SD 10.9] years) were randomized: 636 patients (13.4%) were <55 years of age, 1242 (26.2%) were 55 to 64 years of age, 1717 (36.2%) were 65 to 74 years of age, and 1149 (24.2%) were ≥75 years of age. The rate of the primary outcome (per 100 person-years, placebo arm) in each age group was 13.6 (95% CI, 10.4-17.9), 15.7 (95% CI, 13.2-18.7), 15.1 (95% CI, 13.1-17.5), and 18.0 (95% CI, 15.2-21.4) with corresponding dapagliflozin/placebo hazard ratios of 0.87 (95% CI, 0.60-1.28), 0.71 (95% CI, 0.55-0.93), 0.76 (95% CI, 0.61-0.95), and 0.68 (95% CI, 0.53-0.88;  P  for interaction=0.76). Consistent benefits were observed for the components of the primary outcome, all-cause mortality, and symptoms. Although adverse events and study drug discontinuation increased with age, neither was significantly more common with dapagliflozin in any age group.
CONCLUSIONS


Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of age studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03036124.",2020,"There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.
","['Heart Failure', '95 mm Hg and estimated glomerular filtration rate <30 mL·min -1 ·1.73 m -2 ', '4744 patients 22 to 94 years of age (mean age, 66.3 [SD 10.9] years) were randomized: 636 patients (13.4%) were <55 years of age, 1242 (26.2%) were 55 to 64 years of age, 1717 (36.2%) were 65 to 74 years of age, and 1149 (24.2%) were ≥75 years of age', 'Patients in New York Heart Association functional class II or greater with a left ventricular ejection fraction ≤40% and a modest elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide) were eligible', 'patients with heart failure and reduced ejection fraction']","['placebo', 'Dapagliflozin', 'dapagliflozin']","['systolic blood pressure', 'tolerability or safety events', 'Efficacy and Safety', 'risk of death and worsening heart failure', 'composite of an episode of worsening heart failure (heart failure hospitalization or urgent heart failure visit) or cardiovascular death, whichever occurred first', 'Ejection Fraction']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3811844'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",636.0,0.305807,"There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.
","[{'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Argentina (F.M.).'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil (J.C.N.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taiwan (C.E.-C.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology of Russia, Moscow (S.T.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine (S.D.S.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group (M.S.S.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Dutkiewicz-Piasecka', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland (M.D.-P.).'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., M. Söjstrand, A.M.L.).'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (M. Serenelli, M.C.P., P.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044133']
657,31733182,Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement.,"BACKGROUND


Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known.
METHODS


In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed.
RESULTS


A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively).
CONCLUSIONS


In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).",2020,"Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5).","['patients without an indication for long-term anticoagulation who had undergone successful TAVR, a', '231 patients were enrolled', 'patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a']","['transcatheter aortic-valve replacement (TAVR', 'rivaroxaban', 'rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin', 'rivaroxaban-based antithrombotic strategy', 'Transcatheter Aortic-Valve Replacement']","['Thickening of at least one leaflet', 'percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction', 'Leaflet Motion', 'risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding', 'motion reduction', 'higher risk of death or thromboembolic complications', 'Leaflet thickening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",231.0,0.454038,"Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5).","[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Jilaihawi', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Leipsic', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Annapoorna S', 'Initials': 'AS', 'LastName': 'Kini', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Karsten T', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Won-Keun', 'Initials': 'WK', 'LastName': 'Kim', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Balan', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Van Mieghem', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Ole N', 'Initials': 'ON', 'LastName': 'Mathiassen', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Arnold', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Ana H C', 'Initials': 'AHC', 'LastName': 'Guimarães', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Bjarne L', 'Initials': 'BL', 'LastName': 'Nørgaard', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': ""From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911426']
658,31835186,Alcohol and disgust: An intimate relationship.,"BACKGROUND


Alcohol intoxication has been associated with increases in risk taking behavior and more ambiguously, alterations in emotional perception. In the first study of its kind, we examine how theories of disgust can be used to help explain these effects.
METHODS


Using a single-blind procedure, participants (n = 73) were randomly allocated to an alcohol (Males: 0.68 g/kg; Females: 0.60 g/kg) or placebo condition and then completed a psychometric measure of disgust (TDDS).
RESULTS


Results revealed a non-significant trend toward lower disgust sensitivity in the alcohol versus placebo condition. We did however find a significant negative correlation, whereby increases in breath alcohol level were associated with decreased pathogen disgust.
CONCLUSIONS


These findings demonstrate a relationship between breath alcohol level and disgust sensitivity which could help explain differences in risk associated behavior.",2020,"We did however find a significant negative correlation, whereby increases in breath alcohol level were associated with decreased pathogen disgust.
",['participants (n\u202f=\u202f73'],"['placebo condition and then completed a psychometric measure of disgust (TDDS', 'Alcohol and disgust']","['breath alcohol level', 'disgust sensitivity', 'risk taking behavior']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0433327,"We did however find a significant negative correlation, whereby increases in breath alcohol level were associated with decreased pathogen disgust.
","[{'ForeName': 'Lorenzo D', 'Initials': 'LD', 'LastName': 'Stafford', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, Department of Psychology, University of Portsmouth, UK. Electronic address: lorenzo.Stafford@port.ac.uk.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Sekulla', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, Department of Psychology, University of Portsmouth, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Morrison', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, Department of Psychology, University of Portsmouth, UK.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Fleischman', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, Department of Psychology, University of Portsmouth, UK.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Harvey', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, Department of Psychology, University of Portsmouth, UK.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107780']
659,31467033,Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIG MS .,"BACKGROUND


In PARADIG MS , a double-blind phase III trial in 215 paediatric patients with multiple sclerosis (MS) (10 to <18 years), fingolimod administered for up to 2 years significantly reduced the annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions compared with interferon (IFN) β-1a.
OBJECTIVES


To investigate (1) differences between treatment groups across subpopulations (treatment-naïve, younger/prepubertal patients); (2) disability progression.
METHODS


ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations. Changes in Expanded Disability Status Scale (EDSS), and in 3 month (3M) and 6 month (6M) confirmed disability progression (CDP) were evaluated post hoc.
RESULTS


In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population. Model-based ARR reductions in younger patients (≤12 years) were 91.9%-94.6%. Twice as many IFN β-1a-treated than fingolimod-treated patients had worse EDSS scores at study end (20.6% vs 10.5%, p=0.043). Risk reductions in 3M-CDP and 6M-CDP were 77.2% (p=0.007) and 80.2% (p=0.040), respectively.
CONCLUSIONS


Fingolimod in paediatric MS was associated with consistent control of disease activity versus IFN β-1a (including treatment-naïve and younger patients) and resulted in less disability progression for up to 2 years.
TRIAL REGISTRATION NUMBER


NCT01892722.",2020,"In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population.","['215 paediatric patients with multiple sclerosis (MS) (10 to <18 years', 'paediatric-onset multiple sclerosis', 'younger patients (≤12 years', 'ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations']","['interferon (IFN) β-1a', 'fingolimod versus IFN β-1a']","['Risk reductions in 3M-CDP and 6M-CDP', 'Expanded Disability Status Scale (EDSS), and in 3\u2009month (3M) and 6\u2009month (6M) confirmed disability progression (CDP', 'annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions', 'disability progression', 'EDSS scores', 'ARR and n/neT2 lesions']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",215.0,0.0515039,"In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population.","[{'ForeName': 'Kumaran', 'Initials': 'K', 'LastName': 'Deiva', 'Affiliation': 'Department of Pediatric Neurology, National Referral Center for Rare Inflammatory Brain and Spinal Diseases, Hopitaux Universitaires Paris-Sud, Le Kremlin-Bicetre, France kumaran.deiva@bct.aphp.fr.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Huppke', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence, University Medical Center Göttingen, Gottingen, Germany.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Banwell', 'Affiliation': ""Perelman School of Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gärtner', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, German Center for Multiple Sclerosis in Childhood and Adolescence, University Medical Center Göttingen, Gottingen, Germany.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Pediatric MS Center, NYU Langone Health, New York City, New York, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Stites', 'Affiliation': 'Neuroscience Department, Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gregory Lewis', 'Initials': 'GL', 'LastName': 'Pearce', 'Affiliation': 'Statistics Department, GCE Solutions, Bloomington, Illinois, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Neuroscience Development Unit, Novartis Pharma AG, Basel, Switzerland.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-321124']
660,31884492,Multimodal Balance Training Supported by Rhythmical Auditory Stimuli in Parkinson's Disease: A Randomized Clinical Trial.,"BACKGROUND


Balance impairment in Parkinson's disease (PD) improves only partially with dopaminergic medication. Therefore, non-pharmacological interventions such as physiotherapy are important elements in clinical management. External cues are often applied to improve gait, but their effects on balance control are unclear.
OBJECTIVE/METHODS


We performed a prospective, single-blind, randomized clinical trial to study the effectiveness of balance training with and without rhythmical auditory cues. We screened 201 volunteers by telephone; 154 were assigned randomly into three groups: (1) multimodal balance training supported by rhythmical auditory stimuli (n = 56) (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmical auditory stimuli (n = 50); and (3) control intervention involving a general education program (n = 48). Training was performed for 5 weeks, two times/week. Linear mixed models were used for all outcomes. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by a single, blinded assessor at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post intervention, RAS-supported multimodal balance training was more effective than regular multimodal balance training on MBEST (difference 3.5 (95% Confidence Interval (CI) 2.2; 4.8)), p < 0.001). Patients allocated to both active interventions improved compared to controls (MBEST estimated mean difference versus controls 6.6 (CI 5.2; 8.0), p < 0.001 for RAS-supported multimodal balance training; and 3.0 (CI 2.7; 5.3), p < 0.001 for regular multimodal balance training). Improvements were retained at one-month follow-up for both active interventions, but only the RAS-supported multimodal balance training group maintained its improvement at 6 months.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance, but RAS-supported multimodal balance training-adding rhythmical auditory cues to regular multimodal balance training-has greater and more sustained effects.",2020,"Improvements were retained at one-month follow-up for both active interventions, but only the RAS-supported multimodal balance training group maintained its improvement at 6 months.
","[""Parkinson's disease (PD"", ""Parkinson's Disease"", '201 volunteers by telephone; 154']","['Multimodal Balance Training', 'multimodal balance training supported by rhythmical auditory stimuli (n\u200a=\u200a56) (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmical auditory stimuli (n\u200a=\u200a50); and (3) control intervention involving a general education program', 'balance training with and without rhythmical auditory cues']",['Mini-BESTest (MBEST) score'],"[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",201.0,0.0385253,"Improvements were retained at one-month follow-up for both active interventions, but only the RAS-supported multimodal balance training group maintained its improvement at 6 months.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medial Centre, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Department of Neurology, University of São Paulo, Movement Disorder Center, São Paulo, Brazil.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Department of Rehabilitation, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.'}]",Journal of Parkinson's disease,['10.3233/JPD-191752']
661,31958337,Anti-Müllerian hormone and letrozole levels in boys with constitutional delay of growth and puberty treated with letrozole or testosterone.,"STUDY QUESTION


Does treatment of constitutional delay of growth and puberty (CDGP) in boys with aromatase inhibitor letrozole (Lz) or conventional low-dose testosterone (T) have differing effects on developing seminiferous epithelium?
SUMMARY ANSWER


Anti-Müllerian hormone (AMH) declined similarly in both treatment groups, and the two Sertoli cell-derived markers (AMH and inhibin B (iB)) exhibited differing responses to changes in gonadotrophin milieu.
WHAT IS KNOWN ALREADY


Boys with CDGP may benefit from puberty-inducing medication. Peroral Lz activates gonadotrophin secretion, whereas intramuscular low-dose T may transiently suppress gonadotrophins and iB.
STUDY DESIGN, SIZE, DURATION


Sera of 28 boys with CDGP who participated in a randomised, controlled, open-label trial at four paediatric centres in Finland between August 2013 and January 2017 were analysed. The patients were randomly assigned to receive either Lz (2.5 mg/day) (n = 15) or T (1 mg/kg/month) (n = 13) for 6 months.
PARTICIPANTS/MATERIALS, SETTING, METHODS


The 28 patients were at least 14 years of age, showed first signs of puberty, wanted medical attention for CDGP and were evaluated at 0, 3, 6 and 12 months of visits. AMH levels were measured with an electrochemiluminescence immunoassay and Lz levels with liquid chromatography coupled with tandem mass spectrometry.
MAIN RESULTS AND THE ROLE OF CHANCE


AMH levels decreased in both treatment groups during the 12-month follow-up (P < 0.0001). Between 0 and 3 months, the changes in gonadotrophin levels (increase in the Lz group, decrease in the T group) correlated strongly with the changes in levels of iB (FSH vs iB, r = 0.55, P = 0.002; LH vs iB, r = 0.72, P < 0.0001), but not with the changes in AMH (P = NS). At 12 months, AMH levels did not differ between the groups (P = NS). Serum Lz levels (range, 124-1262 nmol/L) were largely explained by the Lz dose per weight (at 3 months r = 0.62, P = 0.01; at 6 months r = 0.52, P = 0.05). Lz levels did not associate with changes in indices of hypothalamic-pituitary-gonadal axis activity or Sertoli cell markers (in all, P = NS).
LIMITATIONS, REASONS FOR CAUTION


The original trial was not blinded for practical reasons and included a limited number of participants.
WIDER IMPLICATIONS OF THE FINDINGS


In early puberty, treatment-induced gonadotrophin stimulus was unable to counteract the androgen-mediated decrease in AMH, while changes in iB levels were associated with changes in gonadotrophin levels. AMH decreased similarly in both groups during the treatment, reassuring safety of developing seminiferous epithelium in both treatment approaches. Since a fixed dose of Lz induced variable serum Lz levels with a desired puberty-promoting effect in all boys, more research is needed to aim at a minimal efficient dose per weight.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by the Academy of Finland, the Foundation for Pediatric Research, the Emil Aaltonen Foundation, Sigrid Juselius Foundation and Helsinki University Hospital Research Funds. The authors have nothing to disclose.
TRIAL REGISTRATION NUMBER


NCT01797718.",2020,"Lz levels did not associate with changes in indices of hypothalamic-pituitary-gonadal axis activity or Sertoli cell markers (in all, P = NS).
","['The 28 patients were at least 14\xa0years of age, showed first signs of puberty, wanted medical attention for CDGP and were evaluated at 0, 3, 6 and 12\xa0months of visits', 'constitutional delay of growth and puberty (CDGP) in boys with', 'Sera of 28 boys with CDGP who participated in a randomised, controlled, open-label trial at four paediatric centres in Finland between August 2013 and January 2017 were analysed', 'boys with constitutional delay of growth and puberty treated with']","['CDGP', 'aromatase inhibitor letrozole (Lz) or conventional low-dose testosterone (T', 'Lz', 'Peroral Lz activates gonadotrophin secretion', 'letrozole or testosterone']","['reassuring safety of developing seminiferous epithelium', 'AMH', 'hypothalamic-pituitary-gonadal axis activity or Sertoli cell markers', 'gonadotrophin levels', 'Serum Lz levels', 'iB levels', 'Lz levels', 'levels of iB', 'AMH levels', 'changes in gonadotrophin levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449990', 'cui_str': 'First sign (attribute)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0342538', 'cui_str': 'Constitutional delay of growth and puberty (disorder)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0546642', 'cui_str': 'Gonadotrophins'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]","[{'cui': 'C0557055', 'cui_str': 'Reassuring (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036629', 'cui_str': 'Seminiferous Epithelium'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036770', 'cui_str': 'Sertoli Cells'}, {'cui': 'C0542494', 'cui_str': 'Finding of gonadotrophin level (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",28.0,0.0763733,"Lz levels did not associate with changes in indices of hypothalamic-pituitary-gonadal axis activity or Sertoli cell markers (in all, P = NS).
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kohva', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Varimo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Huopio', 'Affiliation': 'Department of Pediatrics, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tenhola', 'Affiliation': 'Department of Pediatrics, Kymenlaakso Central Hospital, Kotka, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Voutilainen', 'Affiliation': 'Department of Pediatrics, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Toppari', 'Affiliation': 'Department of Pediatrics, Turku University Hospital and Institute of Biomedicine, Research Centre for Integrated Physiology and Pharmacology, University of Turku, Turku, Finland.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Miettinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vaaralahti', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Viinamäki', 'Affiliation': 'Department of Clinical Pharmacology, and Individualized Drug Therapy Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Backman', 'Affiliation': 'Department of Clinical Pharmacology, and Individualized Drug Therapy Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raivio', 'Affiliation': ""Children's Hospital, Pediatric Research Center, Helsinki University Hospital, Helsinki, Finland.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez231']
662,31958991,"A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women.","Korean American women have substantially greater incidence rates of cervical cancer and the lowest rates of cervical cancer screening in the United States. However, there has been minimal research to promote human papillomavirus (HPV) vaccination among this population. A pilot randomized controlled trial was conducted to evaluate preliminary effectiveness of a storytelling video intervention using mobile, Web-based technology. One hundred and four Korean American college women were randomized to the experimental group (storytelling video) or the comparison group (information-based written material). The effects of the intervention were assessed immediately postintervention and at the 2-month follow-up. Both groups improved in knowledge of and attitude toward the HPV vaccine at the postintervention. At the 2-month follow-up, the experimental group was twice as likely to receive the HPV vaccine compared to the comparison group. This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.",2020,This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.,"['Korean American women', 'One hundred and four Korean American college women', 'Korean American College Women']","['experimental group (storytelling video) or the comparison group (information-based written material', 'Promote Human Papillomavirus Vaccination', 'storytelling video intervention', 'storytelling video intervention using mobile, Web-based technology', 'HPV vaccine']",['knowledge of and attitude'],"[{'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",104.0,0.0631653,This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.,"[{'ForeName': 'Minjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Haeok', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kiang', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Aronowitz', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Lisa Kennedy', 'Initials': 'LK', 'LastName': 'Sheldon', 'Affiliation': 'Oncology Nursing Society, Pittsburgh, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119894589']
663,31953482,"Effect of probiotics on multi-resistant organism colonisation in persons with spinal cord injury: secondary outcome of ProSCIUTTU, a randomised placebo-controlled trial.","STUDY DESIGN


Randomised double-blind placebo-controlled trial.
OBJECTIVES


Multi-resistant organism (MRO) colonisation is common in people with SCI. We aimed to determine whether Lactobacillus reuteri RC-14 + Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 (LGG-BB12) are effective in preventing or clearing MRO colonisation.
SETTING


New South Wales, Australia.
METHODS


The 207 SCI participants were randomised to one of four arms: (i) RC14-GR1 + LGG-BB12, (ii) RC14-GR1 + placebo, (iii) LGG-BB12 + placebo or (iv) double placebos for 6 months. Microbiological samples of nose, groin, urine and bowel were taken at baseline, 3 and 6 months. Analysis was conducted for the presence of methicillin-resistant Staphylococcus aureus (MRSA), multi-resistant gram-negative organisms (MRGNs) and vancomycin-resistant enterococcus (VRE). The outcomes were clearance of, or new colonisation with MRSA, MRGN, VRE or MROs and whether participants remained free of MRSA, MRGN, VRE or MROs throughout the study. Risk factors associated with an outcome were adjusted for using nominal or binary logistic regression.
RESULTS


There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001). Participants who intermittent self-catheterised (IMC) were more likely to remain MRO-free than those utilising SPC or IDCs (OR 2.80, 95% CI, 1.41-5.54, P = 0.009).
CONCLUSIONS


Probiotics are ineffective at clearing MROs in people with SCI. However, RC14-GR1 is effective at preventing new colonisation with MRGNs. The use of IMC significantly improves the chance of remaining MRO-free.",2020,"There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001).","['persons with spinal cord injury', '207 SCI participants', 'New South Wales, Australia', 'people with SCI']","['placebo', 'probiotics', 'IMC', 'RC14-GR1\u2009+\u2009LGG-BB12, (ii) RC14-GR1\u2009+\u2009placebo, (iii) LGG-BB12\u2009+\u2009placebo or (iv) double placebos', 'vancomycin-resistant enterococcus (VRE', 'Lactobacillus reuteri RC-14\u2009+\u2009Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG\u2009+\u2009Bifidobacterium BB-12 (LGG-BB12', 'RC14-GR1']","['new MRGN colonisation', 'clearance of, or new colonisation with MRSA, MRGN, VRE or MROs and whether participants remained free of MRSA, MRGN, VRE or MROs', 'Microbiological samples of nose, groin, urine and bowel']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C4280067', 'cui_str': 'Bifidobacterium BB-12'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0042037'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}]",207.0,0.653716,"There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001).","[{'ForeName': 'Swee-Ling', 'Initials': 'SL', 'LastName': 'Toh', 'Affiliation': 'Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, NSW, Australia. SweeLing.Toh@health.nsw.gov.au.'}, {'ForeName': 'Bonsan Bonne', 'Initials': 'BB', 'LastName': 'Lee', 'Affiliation': 'Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Simpson', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Rice', 'Affiliation': 'Singapore Centre for Environmental Life Sciences Engineering and the School of Biological Sciences, Nanyang Technological University, Nanyang, Singapore.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kotsiou', 'Affiliation': 'Department of Infectious Diseases and Microbiology, NSW Health Pathology, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Obaydullah', 'Initials': 'O', 'LastName': 'Marial', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and UNSW Sydney, Sydney, NSW, Australia.'}]",Spinal cord,['10.1038/s41393-020-0420-z']
664,29699717,[Effectiveness of a new model of telephone derivation shared between primary care and hospital care].,"AIM


The purpose of this study is to find out whether telephone referral from Primary Health Care to Internal Medicine Consult manages to reduce waiting days as compared to traditional referral. This study also aims to know how acceptable is the telephone referral to general practitioners and their patients.
DESIGN


No blind randomized controlled clinical trial.
SETTING


Northern Huelva Health District.
PARTICIPANTS


154 patients.
INTERVENTIONS


Patients referrals from intervention clinicians were sent via telephone consultation, whereas patients referrals from control clinicians were sent by traditional via.
MEASUREMENTS


Number of days from referral request to Internal Medicine Consult. Number of telephone and traditional referrals. Number of doctors and patients denied. Denial reasons.
RESULTS


A statistically significant difference was found between groups, with an average of 27 (21-34) days. Among General Practitioners, 8 of the first 58 total doctors after randomization and, subsequently, 6 of the 20 doctors of the test group refused to engage in the trial because they considered ""excessive time and effort consuming"". 50% of patients referred by the 14 General Practitioners finally randomized to the intervention group were denied referral by telephone due to patient's complexity.
CONCLUSIONS


Telephone referral significantly reduces waiting days for Internal Medicine consult. This type of referral did not mean an ""excessive time and effort consuming"" to General Practitioners and was not all that beneficial to complex patients.",2019,"A statistically significant difference was found between groups, with an average of 27 (21-34) days.","['general practitioners and their patients', 'General Practitioners, 8 of the first 58 total doctors after randomization and, subsequently, 6 of the 20 doctors of the test group refused to engage in the trial because they considered ""excessive time and effort consuming', 'Northern Huelva Health District', '50% of patients referred by the 14 General Practitioners', '154 patients']",['Patients referrals from intervention clinicians were sent via telephone consultation'],[],"[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]",[],154.0,0.0351936,"A statistically significant difference was found between groups, with an average of 27 (21-34) days.","[{'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Azogil-López', 'Affiliation': 'Consultorios de Los Marines y Cortelazor, Huelva, España.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Pérez-Lázaro', 'Affiliation': 'Escuela Andaluza de Salud Pública, Granada, España.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ávila-Pecci', 'Affiliation': 'Centro de Salud de Almonte, Huelva, España.'}, {'ForeName': 'Esther María', 'Initials': 'EM', 'LastName': 'Medrano-Sánchez', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y podología, Universidad de Sevilla, Sevilla, España. Electronic address: emedrano@us.es.'}, {'ForeName': 'María Valle', 'Initials': 'MV', 'LastName': 'Coronado-Vázquez', 'Affiliation': 'Dirección General de Asistencia Sanitaria, Zaragoza, España.'}]",Atencion primaria,['10.1016/j.aprim.2018.02.006']
665,31761477,Decision-making skills as a mediator of the #Tamojunto school-based prevention program: Indirect effects for drug use and school violence of a cluster-randomized trial.,"BACKGROUND


The aim of the present study was to evaluate a formal mediation analysis effect of the #Tamojunto program on adolescents' drug use and violent behavior in schools through decision-making skills using a potential outcomes approach.
METHODS


An in-cluster randomized controlled trial was conducted in 2014-2015 with 6691 7th- and 8th-grade students in 72 public schools in 6 Brazilian cities to evaluate the effects of the European drug prevention program Unplugged, called #Tamojunto in Brazil. Baseline data were collected prior to program implementation, and follow-up data were collected 9 and 21 months later. Mediation analysis using a potential outcomes approach, in which counterfactuals are modeled if positivity is met, was used to evaluate the indirect effects of the program #Tamojunto on the third-wave of drug use (alcohol, tobacco, marijuana, inhalants, and binge drinking) and school violence (bullying or physical, verbal and sexual aggression) assessment through decision-making skills.
RESULTS


When controlling for all covariates, the Total Natural Indirect Effect (TNIE) was significant only for past-year drug use (TNIE = 0.003, 95%CI = 0.001; 0.007). In the adjusted models, 37.5% of the effect of the intervention on drug use was mediated by decision-making skills.
CONCLUSIONS


The #Tamojunto program increased drug use through decreasing decision-making skills. The findings demonstrate that this program changes decision-making skills but in the opposite direction proposed by the theoretical model of the program, suggesting that modifications are needed to produce the intended effect of the program.",2020,"When controlling for all covariates, the Total Natural Indirect Effect (TNIE) was significant only for past-year drug use (TNIE = 0.003, 95%CI = 0.001; 0.007).","['2014-2015 with 6691 7th- and 8th-grade students in 72 public schools in 6 Brazilian cities to evaluate the effects of the European drug prevention program Unplugged, called #Tamojunto in Brazil']",['Tamojunto program'],['Total Natural Indirect Effect (TNIE'],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",72.0,0.0633202,"When controlling for all covariates, the Total Natural Indirect Effect (TNIE) was significant only for past-year drug use (TNIE = 0.003, 95%CI = 0.001; 0.007).","[{'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil; Department of Psychology and Education, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, São Paulo, Brazil. Electronic address: zila.sanchez@unifesp.br.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107718']
666,31788828,"Fractional 1,927 nm Thulium Laser Plus Photodynamic Therapy Compared and Combined for Photodamaged Décolleté Skin: A Side-by-Side Randomized Controlled Trial.","BACKGROUND AND OBJECTIVES


Décolleté photodamage is a common condition typically treated with light and energy-based devices. This study investigated the efficacy and safety of a fractional 1,927 nm thulium laser (TL) alone and combined with photodynamic therapy (PDT).
STUDY DESIGN/MATERIALS AND METHODS


In a 12-week follow-up study, participant décolletés were divided into four treatment areas and randomized to receive a single treatment with field-directed TL, PDT, combination TL-PDT, or lesion-directed curettage control. All actinic keratoses (AKs) underwent lesion-directed curettage before randomization. TL was delivered at 20 mJ/mb, 500 mJ/cm 2  fluence, 5 W, and 8 (n = 6 pts.) or 16 (n = 6 pts.) passes. PDT was performed with 16% methyl aminolevulinate (MAL) creme incubated for 3 h, followed by red light-emitting diode light at 37 J/cm 2  . Outcome measures included clinical assessment of overall photodamage and specific subcomponents, assisted by optical coherence tomography (OCT) imaging.
RESULTS


Twelve women with moderate to severe photodamage on the décolleté and a cumulative total of 184 thin grade I AKs were included. Field-directed treatments TL and combination TL-PDT equally improved the overall photodamage, mottled pigmentation, and rhytides compared with lesion-directed control (P < 0.05). The skin texture improved by TL alone and was further improved by combining TL and PDT (P < 0.05). Median AK complete responses were similar for field-directed interventions TL-PDT (100%), TL (90%), PDT (82%), and lesion-directed curettage control (52%) (P = 0.464). Patients presented with mild local skin responses, slightly more pronounced when combining TL with PDT versus individual treatments (P < 0.05). No scarring or adverse events were observed.
CONCLUSIONS


The 1,927 nm fractional thulium laser is an effective, tolerable, and safe field-directed treatment for décolleté photodamage. Provided alone, TL proved to be as effective as combined TL-PDT for overall photodamage, while a greater improvement in skin texture was achieved using TL and PDT in combination. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"Field-directed treatments TL and combination TL-PDT equally improved the overall photodamage, mottled pigmentation, and rhytides compared with lesion-directed control (P < 0.05).","['Twelve women with moderate to severe photodamage on the décolleté and a cumulative total of 184 thin grade I AKs were included', '2019']","['Fractional 1,927\u2009nm Thulium Laser Plus Photodynamic Therapy', 'TL', 'single treatment with field-directed TL, PDT, combination TL-PDT, or lesion-directed curettage control', 'fractional 1,927\u2009nm thulium laser (TL) alone and combined with photodynamic therapy (PDT']","['skin texture', 'Median AK complete responses', 'overall photodamage, mottled pigmentation, and rhytides', 'efficacy and safety', 'clinical assessment of overall photodamage and specific subcomponents, assisted by optical coherence tomography (OCT) imaging', 'scarring or adverse events', 'mild local skin responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0423752', 'cui_str': 'Skin texture (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302133', 'cui_str': 'Mottling of skin'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C2729169', 'cui_str': 'Wrinkled structure (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1286259', 'cui_str': 'Skin response (observable entity)'}]",184.0,0.0767358,"Field-directed treatments TL and combination TL-PDT equally improved the overall photodamage, mottled pigmentation, and rhytides compared with lesion-directed control (P < 0.05).","[{'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Hendel', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nielsine Nielsens Vej 17, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Mogensen', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nielsine Nielsens Vej 17, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wenande', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nielsine Nielsens Vej 17, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dierickx', 'Affiliation': 'Skinperium, 52 Rue Charles Martel, L-2134, Luxembourg, Luxembourg.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Haedersdal', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nielsine Nielsens Vej 17, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Togsverd-Bo', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nielsine Nielsens Vej 17, 2400, Copenhagen, Denmark.'}]",Lasers in surgery and medicine,['10.1002/lsm.23194']
667,31176137,Evidence for subjective emotional numbing following induced acute dissociation.,"The aim of the study was to examine the effects of acute dissociation on emotional responsivity in healthy individuals. We used a previously validated technique (mirror-gazing, Caputo, 2010) to experimentally induce acute dissociation in non-clinical participants and assessed post-induction subjective responsivity (ratings of valence and arousal) to standardized emotional images. Fifty non-clinical participants were randomised to either the dissociation induction (n = 25) or control conditions (n = 25). The dissociation manipulation effect was corroborated by a significant post-induction elevation in state dissociation in the dissociation-induction group relative to controls (p = .004). The dissociation-induction group rated negative (p = .028) and neutral (p = .025) stimuli as significantly less unpleasant than controls. There was also a non-significant trend for positive stimuli to be rated as less pleasant by the dissociation-induction group compared to controls (p = .060). These findings provide experimental evidence for the short-term alleviation (i.e., emotional numbing) of negative affect during dissociative states, which may serve as a coping mechanism for some individuals. However, this tendency of emotional numbing also reduced positive affective responses to pleasant stimuli to some extent. Further investigation of dissociative phenomena and their impact on emotional processing appears warranted.",2019,The dissociation-induction group rated negative (p = .028) and neutral (p = .025) stimuli as significantly less unpleasant than controls.,"['Fifty non-clinical participants', 'healthy individuals']",['dissociation induction (n\u202f=\u202f25) or control conditions'],"['emotional responsivity', 'positive stimuli']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0462152,The dissociation-induction group rated negative (p = .028) and neutral (p = .025) stimuli as significantly less unpleasant than controls.,"[{'ForeName': 'Ga In', 'Initials': 'GI', 'LastName': 'Shin', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology, & Neuroscience, King's College London, UK.""}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology, & Neuroscience, King's College London, UK; Neuropsychiatry Department, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, UK.""}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Pick', 'Affiliation': ""Section of Cognitive Neuropsychiatry, Institute of Psychiatry, Psychology, & Neuroscience, King's College London, UK. Electronic address: susannah.pick@kcl.ac.uk.""}]",Behaviour research and therapy,['10.1016/j.brat.2019.05.004']
668,31959649,Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.,,2020,,"['Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Placebo', 'Liraglutide']",['Acute Gallbladder or Biliary Disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0538329,,"[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Skelin', 'Affiliation': 'Department of Pharmacy, General Hospital Šibenik, Šibenik, Croatia marko.skelin@bolnica-sibenik.hr.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Rahelić', 'Affiliation': 'University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Skelin', 'Affiliation': 'Faculty of Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Lucijanic', 'Affiliation': 'Department of Hematology, Dubrava University Hospital, Zagreb, Croatia.'}]",Diabetes care,['10.2337/dc19-2039']
669,31959650,Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.,,2020,,"['Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Placebo', 'Liraglutide']",['Acute Gallbladder or Biliary Disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.051179,,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, St. Josef-Hospital (Ruhr University), Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dci19-0067']
670,30897454,"Effect of calf muscle electrical stimulation on rostral fluid shift, snoring and obstructive sleep apnea.","STUDY OBJECTIVES


Overnight fluid shift from the legs into the neck may contribute to the pathogenesis of snoring and obstructive sleep apnea (OSA). The present study investigates the effects of calf muscle electrical stimulation (ES) on reducing leg fluid accumulation while seated, subsequent rostral fluid shift on lying down, and the impact on snoring and OSA.
METHODS


Sixteen non-obese, normotensive men with OSA participated in the study. On the first study day, participants sat for 150 min receiving either active or sham ES through random allocation, then lied supine for 60 min. While seated and supine, leg and neck fluid volumes were measured using bioelectrical impedance to determine the magnitude of fluid shift. On the night of the study day, participants wore a portable sleep apnea diagnostic device overnight to measure snoring and sleep apnea severity. One week later, participants crossed over to the other study condition.
RESULTS


Active calf muscle ES reduced leg fluid accumulation by 46% while seated. Upon lying supine, active ES reduced fluid shift out of the legs by 17% and reduced neck fluid accumulation by 31%. This led to a 15% reduction in snoring index, but did not alleviate OSA.
CONCLUSIONS


One session of calf muscle ES was effective at reducing leg fluid accumulation and rostral fluid shift, which led to a modest reduction in the snoring index, but not OSA. Despite this lack of effect of calf muscle ES in attenuating OSA severity, the reduction in the snoring index suggests that it did have an effect, albeit mild, on upper-airway mechanics.",2019,"Upon lying supine, active ES reduced fluid shift out of the legs by 17% and reduced neck fluid accumulation by 31%.","['Sixteen non-obese, normotensive men with OSA participated in the study']","['calf muscle electrical stimulation', 'active or sham ES', 'portable sleep apnea diagnostic device overnight', 'calf muscle electrical stimulation (ES']","['snoring and sleep apnea severity', 'rostral fluid shift, snoring and obstructive sleep apnea', 'neck fluid accumulation', 'snoring index', 'leg fluid accumulation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C1273532', 'cui_str': 'Diagnostic device'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0242705', 'cui_str': 'Fluid Shifts'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.0327511,"Upon lying supine, active ES reduced fluid shift out of the legs by 17% and reduced neck fluid accumulation by 31%.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': 'KITE, Toronto Rehab - University Health Network, Toronto, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Lyons', 'Affiliation': ""KITE, Toronto Rehab - University Health Network, Toronto, Canada; Women's College Research Institute, Women's College Hospital, Toronto, Canada.""}, {'ForeName': 'Geoff R', 'Initials': 'GR', 'LastName': 'Fernie', 'Affiliation': 'KITE, Toronto Rehab - University Health Network, Toronto, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Popovic', 'Affiliation': 'KITE, Toronto Rehab - University Health Network, Toronto, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Malta', 'Affiliation': 'Department of Nutritional Science, University of Toronto, Toronto, Canada; Division of Cardiology, Department of Medicine, Sinai Health System, Toronto, Canada.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Alshaer', 'Affiliation': 'KITE, Toronto Rehab - University Health Network, Toronto, Canada.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Yadollahi', 'Affiliation': 'KITE, Toronto Rehab - University Health Network, Toronto, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada. Electronic address: Azadeh.Yadollahi@uhn.ca.'}]",Sleep medicine,['10.1016/j.sleep.2019.01.035']
671,30909715,The Impact of a Childcare Food Service Intervention on Child Dietary Intake in Care: An Exploratory Cluster Randomized Controlled Trial.,"PURPOSE


To assess the efficacy of a food service implementation intervention designed to increase provision of foods consistent with nutrition guidelines on child consumption of fruit, vegetables, breads/cereals, meat/alternatives, dairy, and diet quality in care.
DESIGN


Exploratory cluster randomized controlled trial.
SETTING


Twenty-five childcare centers in New South Wales, Australia.
SAMPLE


Three hundred ninety-five children aged 2 to 5 years.
INTERVENTION


Centers were randomized to the intervention or control group. Intervention development was guided by the Theoretical Domains Framework and included securing executive support, provision of group training, resources, audit and feedback, and one-on-one support. The intervention was delivered across six months and the study was conducted between March and December 2016.
MEASURES


Child diet was assessed by educators using a validated questionnaire modified for completion in childcare center.
ANALYSIS


Data were analyzed in SAS using generalized linear mixed models adjusted for clustering.
RESULTS


Children in the intervention group consumed significantly higher number of serves of vegetables (0.4 serves;  P  < .001), wholegrain cereals (0.7 serves;  P  = .02), and meat/alternatives (0.5 serves;  P  < .001), and had higher diet quality scores (10.3;  P  < .001).
CONCLUSIONS


A food service intervention targeting the provision of food significantly improved child dietary intake in care. Such findings are relevant to health promotion practitioners responsible for supporting improvements in child diet.",2019,"Children in the intervention group consumed significantly higher number of serves of vegetables (0.4 serves; P < .001), wholegrain cereals (0.7 serves; P = .02), and meat/alternatives (0.5 serves; P < .001), and had higher diet quality scores (10.3; P < .001).
","['Twenty-five childcare centers in New South Wales, Australia', 'Child Dietary Intake in Care', 'SAMPLE:\n\n\nThree hundred ninety-five children aged 2 to 5 years', 'care']","['Childcare Food Service Intervention', 'food service implementation intervention']","['wholegrain cereals', 'child consumption of fruit, vegetables, breads/cereals, meat/alternatives, dairy, and diet quality', 'diet quality scores', 'number of serves of vegetables', 'child dietary intake']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0016490', 'cui_str': 'Food Services'}]","[{'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",395.0,0.0767807,"Children in the intervention group consumed significantly higher number of serves of vegetables (0.4 serves; P < .001), wholegrain cereals (0.7 serves; P = .02), and meat/alternatives (0.5 serves; P < .001), and had higher diet quality scores (10.3; P < .001).
","[{'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Seward', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Taya', 'Initials': 'T', 'LastName': 'Wedesweiler', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': '1 Hunter New England Population Health, Wallsend, New South Wales, Australia.'}]",American journal of health promotion : AJHP,['10.1177/0890117119837461']
672,31918232,The relationship between perceived stress and depression in substance use disorder treatment.,"BACKGROUND


Depression is highly prevalent among individuals with substance use disorders (SUDs), especially women, and has been noted to improve during SUD treatment. Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment. The aim of this study was to investigate among adults enrolled in SUD treatment whether levels of perceived stress and substance use over the course of treatment were related to reduction in depression.
METHODS


This is a secondary analysis of data from the Women's Recovery Group Study. Women (n = 100) were randomized to either single- or mixed-gender group therapy and men (n = 58) received mixed-gender group therapy. Measures of substance use, perceived stress and depressive symptoms were collected for 6 months following treatment completion. In this study, we used lagged mixed models to investigate whether levels of substance use and perceived stress at each time point were associated with changes in depression at the subsequent time point.
RESULTS


Results indicated that depressive symptoms significantly improved over time. Both substance use and perceived stress were associated with subsequent depressive symptoms. Importantly, stress was associated with symptoms when controlling for substance use, suggesting that changes in depressive symptoms were not solely attributable to levels of substance use.
CONCLUSIONS


These results suggest that both stress and substance use are associated with improvements in depressive symptoms in substance use disorder treatment. Although preliminary, these results provide further support for the importance of targeting stress reduction in people with substance use disorders.",2020,Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment.,"['people with substance use disorders', 'individuals with substance use disorders (SUDs), especially women', 'adults enrolled in SUD', 'Women (n\u2009=\u2009100']",['single- or mixed-gender group therapy and men (n\u2009=\u200958) received mixed-gender group therapy'],"['substance use, perceived stress and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.04352,Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment.,"[{'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: kmchugh@mclean.harvard.edu.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Sugarman', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107819']
673,31843975,"Three-Year Outcomes of a Randomized, Double-Blind, Placebo-Controlled Study Assessing Safety and Efficacy of C1 Esterase Inhibitor for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplant Recipients.","BACKGROUND AND OBJECTIVES


Delayed graft function is related to ischemia-reperfusion injury and may be complement dependent. We previously reported from a randomized, placebo-controlled trial that treatment with C1 esterase inhibitor was associated with a shorter duration of delayed graft function and higher eGFR at 1 year. Here, we report longer-term outcomes from this trial.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This is a  post hoc  analysis of a phase 1/2, randomized, controlled trial enrolling 70 recipients of deceased donor kidney transplants at risk for delayed graft function (NCT02134314). Subjects were randomized to receive C1 esterase inhibitor 50 U/kg ( n =35) or placebo ( n =35) intraoperatively and at 24 hours. The cumulative incidence functions method was used to compare graft failure and death over 3.5 years. eGFR slopes were compared using a linear mixed effects model.
RESULTS


Three deaths occurred among C1 esterase inhibitor-treated patients compared with none receiving placebo. Seven graft failures developed in the placebo group compared with one among C1 esterase inhibitor-treated recipients; the cumulative incidence of graft failure was lower over 3.5 years among C1 esterase inhibitor-treated recipients compared with placebo ( P =0.03). Although no difference in eGFR slopes was observed between groups ( P  for group-time interaction =0.12), eGFR declined in placebo-treated recipients (-4 ml/min per 1.73 m 2  per year; 95% confidence interval, -8 to -0.1) but was stable in C1 esterase inhibitor-treated patients (eGFR slope: 0.5 ml/min per 1.73 m 2  per year; 95% confidence interval, -4 to 5). At 3.5 years, eGFR was 56 ml/min per 1.73 m 2  (95% confidence interval, 42 to 70) in the C1 esterase inhibitor group versus 35 ml/min per 1.73 m 2  (95% confidence interval, 21 to 48) in the placebo group, with an estimated mean eGFR difference of 21 ml/min per 1.73 m 2  (95% confidence interval, 2 to 41 ml/min per 1.73 m 2 ).
CONCLUSIONS


Treatment of patients at risk for ischemia-reperfusion injury and delayed graft function with C1 esterase inhibitor was associated with a lower incidence of graft failure.",2020,"At 3.5 years, eGFR was 56 ml/min per 1.73 m 2  (95% confidence interval, 42 to 70) in the C1 esterase inhibitor group versus 35 ml/min per 1.73 m 2  (95% confidence interval, 21 to 48) in the placebo group, with an estimated mean eGFR difference of 21 ml/min per 1.73 m 2  (95% confidence interval, 2 to 41 ml/min per 1.73 m 2 ).
","['70 recipients of deceased donor kidney transplants at risk for delayed graft function (NCT02134314', 'Deceased Donor Kidney Transplant Recipients', ' n =35']","['C1 Esterase Inhibitor', 'Placebo', 'C1 esterase inhibitor', 'placebo']","['Seven graft failures', 'eGFR', 'graft failure and death', 'cumulative incidence of graft failure', 'graft failure', 'eGFR slopes']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}]","[{'cui': 'C2366367', 'cui_str': 'C1 esterase inhibitor (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",70.0,0.764825,"At 3.5 years, eGFR was 56 ml/min per 1.73 m 2  (95% confidence interval, 42 to 70) in the C1 esterase inhibitor group versus 35 ml/min per 1.73 m 2  (95% confidence interval, 21 to 48) in the placebo group, with an estimated mean eGFR difference of 21 ml/min per 1.73 m 2  (95% confidence interval, 2 to 41 ml/min per 1.73 m 2 ).
","[{'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Huang', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vo', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Jua', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Ammerman', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Kathlyn', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Supreet', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Reiad', 'Initials': 'R', 'LastName': 'Najjar', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Peng', 'Affiliation': 'Division of Nephrology, Department of Medicine and.'}, {'ForeName': 'Stanley C', 'Initials': 'SC', 'LastName': 'Jordan', 'Affiliation': 'Division of Nephrology, Department of Medicine and stan.jordan@cshs.org.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.04840419']
674,31831473,Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA 1c  in Andalusia (Spain): PLATEDIAN Study.,"OBJECTIVE


To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes.
RESEARCH DESIGN AND METHODS


PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA 1c  <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) ( n  = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) ( n  = 163). The primary efficacy end point was the mean change of HbA 1c  levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction.
RESULTS


At month 6, the mean change in HbA 1c  levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC ( P  = 0.4941). The number of patients who achieved HbA 1c  <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months ( P  < 0.05).
CONCLUSIONS


The use of telemedicine in patients with type 1 diabetes with HbA 1c  <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.",2020,Significant differences were not found regarding safety end points at 6 months.,"['Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA 1c  in Andalusia (Spain', 'Type 1 Diabetes Mellitus Andalusian Patients', 'A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three', 'patients with type 1 diabetes', 'patients with type 1 diabetes with HbA 1c  <8% (<64 mmol/mol', 'patients with type 1 diabetes with suboptimal metabolic control (HbA 1c  <8% [<64 mmol/mol]), treated with multiple daily injections']","['Telemedicine Care', 'face-to-face visits (control cohort [CC]) ( n  = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC', 'telemedicine visit', 'telemedicine']","['mean change in HbA 1c  levels', 'fear of hypoglycemia', 'mean change of HbA 1c  levels', 'Changes in HRQoL', ""mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",388.0,0.0339528,Significant differences were not found regarding safety end points at 6 months.,"[{'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Ruiz de Adana', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Alhambra-Expósito', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Muñoz-Garach', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Gonzalez-Molero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Colomo', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain nataliacolomo@gmail.com.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Torres-Barea', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario de Jerez, Jerez, Cádiz, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Aguilar-Diosdado', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Florentino', 'Initials': 'F', 'LastName': 'Carral', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Puerto Real, Puerto Real, Cádiz, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Serrano', 'Affiliation': 'Endocrinology and Nutrition Department, Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Martínez-Brocca', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Medical Department, Sanofi Spain, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Palomares', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0739']
675,31181221,Home visits for uncontrolled asthma among low-income adults with patient portal access.,"BACKGROUND


Asthma disproportionately affects low-income and minority adults. In an era of electronic records and Internet-based digital devices, it is unknown whether portals for patient-provider communication can improve asthma outcomes.
OBJECTIVE


We sought to estimate the effect on asthma outcomes of an intervention using home visits (HVs) by community health workers (CHWs) plus training in patient portals compared with usual care and portal training only.
METHODS


Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training. Half were randomized to HVs over 6 months by CHWs to facilitate competency in portal use and promote care coordination.
RESULTS


One hundred seventy (56%) patients used the portal independently. Rates of portal activity did not differ between randomized groups. Asthma control and asthma-related quality of life improved in both groups over 1 year. Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024). Poor neighborhoods and living conditions plus limited Internet access were barriers for patients to complete the protocol and for CHWs to make HVs.
CONCLUSION


For low-income adults with uncontrolled asthma, portal access and CHWs produced small incremental benefits. HVs with emphasis on self-management education might be necessary to facilitate patient-clinician communication and to improve asthma outcomes.",2019,"Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024).","['uncontrolled asthma among low-income adults with patient portal access', 'Asthma disproportionately affects low-income and minority adults', 'Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training', 'One hundred seventy (56%) patients used the portal independently']","['intervention using home visits (HVs) by community health workers (CHWs) plus training', 'usual care and portal training only']","['yearly hospitalization rate', 'Rates of portal activity', 'Asthma control and asthma-related quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",301.0,0.0640998,"Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024).","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; University of Pennsylvania Health System, Philadelphia, Pa. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple Physicians, Temple University Health System, Philadelphia, Pa.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; University of Pennsylvania Health System, Philadelphia, Pa.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pa; Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Howell', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pa.'}, {'ForeName': 'Maryori N', 'Initials': 'MN', 'LastName': 'Canales', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.05.030']
676,31955921,A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial.,"RATIONALE & OBJECTIVE


Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD.
STUDY DESIGN


Randomized controlled trial.
SETTING & PARTICIPANTS


Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol/d.
INTERVENTION


Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period.
OUTCOMES


Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation.
RESULTS


Baseline estimated glomerular filtration rate was 55.0±22.0mL/min/1.73m 2 . During the intervention period, sodium excretion decreased in the intervention group from 188±8 (SE) to 148±8mmol/d (P<0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140±3 to 132±3mm Hg (P<0.001), but was unchanged in the control group. Mean difference in SBP across groups was-4.7 (95% CI, -10.7 to 1.3) mm Hg (P=0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160±8mmol/d (P=0.01), while it decreased in the control group from 174±9 at the end of the intervention period to 154±9mmol/d (P=0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase.
LIMITATIONS


Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up.
CONCLUSIONS


A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group.
FUNDING


Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov with study number NCT02132013.",2020,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","['Nephrology outpatient clinics in 4 Dutch hospitals', 'patients with CKD', '99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol', 'Patients With CKD', 'Patients with chronic kidney disease (CKD']","['Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching']","['blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation', 'sodium intake', 'systolic blood pressure (SBP', 'glomerular filtration rate', 'mean sodium excretion', 'SBP', 'sodium excretion', 'Efficacy', 'Mean difference in SBP']","[{'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2316401', 'cui_str': 'CKD stage 1'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",99.0,0.0474961,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Klaassen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: g.klaassen@umcg.nl.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Meuleman', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Verschuur', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Elisabeth J M', 'Initials': 'EJM', 'LastName': 'Straathof', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Willem Jan W', 'Initials': 'WJW', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paul J M', 'Initials': 'PJM', 'LastName': 'van der Boog', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Olivier A', 'Initials': 'OA', 'LastName': 'Blanson Henkemans', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Otten', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dijk', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Gerjan J', 'Initials': 'GJ', 'LastName': 'Navis', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.10.012']
677,30924570,Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study.,"AIMS


To compare the effects of a low carbohydrate diet (LCD < 100 g carbohydrate/d) and a high carbohydrate diet (HCD > 250 g carbohydrate/d) on glycaemic control and cardiovascular risk factors in adults with type 1 diabetes.
MATERIALS AND METHODS


In a randomized crossover study with two 12-week intervention arms separated by a 12-week washout, 14 participants using sensor-augmented insulin pumps were included. Individual meal plans meeting the carbohydrate criteria were made for each study participant. Actual carbohydrate intake was entered into the insulin pumps throughout the study.
RESULTS


Ten participants completed the study. Daily carbohydrate intake during the two intervention periods was (mean ± standard deviation) 98 ± 11 g and 246 ± 34 g, respectively. Time spent in the range 3.9-10.0 mmol/L (primary outcome) did not differ between groups (LCD 68.6 ± 8.9% vs. HCD 65.3 ± 6.5%, P = 0.316). However, time spent <3.9 mmol/L was less (1.9 vs. 3.6%, P < 0.001) and glycaemic variability (assessed by coefficient of variation) was lower (32.7 vs. 37.5%, P = 0.013) during LCD. No events of severe hypoglycaemia were reported. Participants lost 2.0 ± 2.1 kg during LCD and gained 2.6 ± 1.8 kg during HCD (P = 0.001). No other cardiovascular risk factors, including fasting levels of lipids and inflammatory markers, were significantly affected.
CONCLUSIONS


Compared with an intake of 250 g of carbohydrate per day, restriction of carbohydrate intake to 100 g per day in adults with type 1 diabetes reduced time spent in hypoglycaemia, glycaemic variability and weight with no effect on cardiovascular risk factors.",2019,No events of severe hypoglycaemia were reported.,"['adults with type', 'adults with type 1 diabetes', '14 participants using sensor-augmented insulin pumps were included', 'type 1 diabetes']","['low carbohydrate diet (LCD\u2009<\u2009100\u2009g carbohydrate/d) and a high carbohydrate diet (HCD\u2009>\u2009250\u2009g carbohydrate/d', 'Low versus high carbohydrate diet']","['fasting levels of lipids and inflammatory markers', 'time spent in hypoglycaemia, glycaemic variability and weight with no effect on cardiovascular risk factors', 'glycaemic control and cardiovascular risk factors', 'Daily carbohydrate intake', 'cardiovascular risk factors', 'Time spent', 'glycaemic variability', 'severe hypoglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1301751', 'cui_str': 'No effect'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",14.0,0.0424814,No events of severe hypoglycaemia were reported.,"[{'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Merete B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Nermin', 'Initials': 'N', 'LastName': 'Serifovski', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Damm-Frydenberg', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jens-Erik B', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Fløyel', 'Affiliation': 'Department of Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Størling', 'Affiliation': 'Department of Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ajenthen', 'Initials': 'A', 'LastName': 'Ranjan', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13725']
678,30962409,"HL301 in the treatment of acute bronchitis: a phase 2b, randomized, double-blind, placebocontrolled, multicenter study.","BACKGROUND/AIMS


There is insufficient quality data to recommend the use of herbs for the treatment of acute bronchitis. Small number of randomized trials of plant extracts for this purpose were determined to be low quality and there are concerns for the safety. HL301 is a combined product of seven medicinal plants. In the present study, we tried to evaluate the efficacy and safety of HL301 for the treatment of acute bronchitis with a randomized, double-blind, placebo-controlled, multicenter trial design.
METHODS


A total of 166 patients with acute bronchitis were randomized to receive placebo or HL301 (600 mg/day) for 7 days. The primary endpoint was change in bronchitis severity score (BSS) from baseline visit (visit 2) to the end of treatment (visit 3). Other efficacy variables were the change of each component of the BSS (cough, sputum, dyspnea, chest pain, and crackle) with treatment, response rate, improvement rate, satisfaction rate and number of rescue medications taken.
RESULTS


Changes in the BSS from visit 2 to visit 3 were higher in the HL301 group than in the placebo group both in the full analysis set (4.57 ± 1.82 vs. 3.15 ± 3.08, p < 0.01) and in the per protocol set (4.62 ± 1.81 vs. 3.30 ± 3.03, p < 0.01). Four BSS components (cough, sputum, dyspnea, and chest pain) improved more with HL301 treatment than with placebo treatment. Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group.
CONCLUSION


HL301 (600 mg/day) was effective and safe for symptomatic treatment of acute bronchitis.",2020,"Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group.
","['acute bronchitis', '166 patients with acute bronchitis']","['HL301', 'placebo', 'placebo or HL301', 'plant extracts', 'placebocontrolled']","['BSS (cough, sputum, dyspnea, chest pain, and crackle) with treatment, response rate, improvement rate, satisfaction rate and number of rescue medications taken', 'satisfaction rates and less use of rescue medication', 'change in bronchitis severity score (BSS', 'efficacy and safety', 'Four BSS components (cough, sputum, dyspnea, and chest pain']","[{'cui': 'C0149514', 'cui_str': 'Acute tracheobronchitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032081', 'cui_str': 'Plant Extracts'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",166.0,0.642088,"Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group.
","[{'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Park', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Chin Kook', 'Initials': 'CK', 'LastName': 'Rhee', 'Affiliation': ""Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Joo Hun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sang Yeub', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Do Jin', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Dong Gyu', 'Initials': 'DG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.'}, {'ForeName': 'Jae Yeol', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.181']
679,31758578,"Hanging donor lungs give good short-, mid- and long-term results in lung transplantation.","BACKGROUND


Hanging donors are considered as marginal donors and frequently unsuitable for lung transplantation. However, there is no evidence of higher lung transplantation (LTx) morbidity-mortality with lungs providing by hanging donor.
METHODS


Between January 2010 and July 2015, we performed a retrospective study at Foch hospital. We aimed to assess whether hanging donor grafts are suitable for lung transplantation.
RESULTS


A total of 299 LTx were performed. Subjects were allocated to a hanging group (HG) (n = 20) and a control group (CG) (n = 279). Donor and recipient characteristics did not differ. Primary graft dysfunction (PGD) at 72 hours was comparable in both groups (P = .75). The median duration of postoperative mechanical ventilation (1 [range, 0-84] vs 1 [range, 0-410] day, P = .35), the hospital length of stay (31 days [20-84] vs 32 days [12-435], P = .36) did not differ between the two groups. No statistically significant difference was found in 1-year and 5-year survival between the HG (83% and 78%) and the CG (86% and 75%), P = .85.
CONCLUSION


We believe that hanging donors should be considered as conventional donors with particular caution in the final evaluation of the graft and in perioperative management.",2020,"No statistically significant difference was found in 1-year and 5-year survival between the HG (83% and 78%) and the CG (86% and 75%), p = 0.85.
CONCLUSION


",['Between January 2010 and July 2015'],"['hanging group (HG', 'control group (CG', 'hanging donor grafts']","['hospital length of stay', 'Primary graft dysfunction (PGD', 'median duration of post-operative mechanical ventilation', '1-year and 5-year survival', 'higher lung transplantation (LTx) morbidity-mortality']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0730393', 'cui_str': 'Donor graft (substance)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0033558', 'cui_str': 'PGD'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0363373,"No statistically significant difference was found in 1-year and 5-year survival between the HG (83% and 78%) and the CG (86% and 75%), p = 0.85.
CONCLUSION


","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'De Wolf', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Renard', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehouerou', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Glorion', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Ciprian', 'Initials': 'C', 'LastName': 'Pricopi', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bonnette', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Parquin', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roux', 'Affiliation': 'Department of Pneumology, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Leguen', 'Affiliation': 'Department of Anaesthesiology, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Chapelier', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Sage', 'Affiliation': 'Thoracic Surgery and Lung Transplantation Department, Foch Hospital, Suresnes, France.'}]",Clinical transplantation,['10.1111/ctr.13758']
680,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
681,31928846,Clinical and MRI Predictors of Conversion From Mild Behavioural Impairment to Dementia.,"OBJECTIVE


As an analogy with mild cognitive impairment (MCI), the mild behavioral impairment (MBI) construct has been proposed as a diagnostic label for those presenting late-onset behavioral symptoms. To date, however, the clinical, cognitive, and structural imaging features associated with an increased risk of conversion from MBI to dementia are poorly understood.
METHODS


We retrospectively analyzed the cognitive performance and structural brain MRI of 113 subjects, with a clinical follow-up of at least 4 years available. Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4). In the Group A, cognitive and structural variables were compared between converters (at 4 years) and nonconverters and then verified in the Group B group.
RESULTS


In the Group A, 14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD). Converters presented at baseline lower executive function scores and total Theory of Mind (ToM scores), as well as more severe focal frontal atrophy. In the Group B, 13 subjects converted to bv-FTD and none to AD. The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
CONCLUSION


The combined presence of executive deficit, impaired ToM, and presence of isolated frontal atrophy was associated with risk of progression from MBI to a clinically evident neurodegenerative condition, mainly bv-FTD, over a 4-year period.",2020,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
","['113 subjects, with a clinical follow-up of at least 4 years available', 'Subjects were randomly assigned to a Group A (56 subjects; age: 65.4 ± 7.9 years, 15 females, MMSE score: 28.4 ± 2.3)) or to a Group B (57 subjects, age: 66.6 ± 6.4, 17 females, MMSE score: 28.0 ± 1.4', ""14 patients converted to behavioral-variant of frontotemporal dementia (bv-FTD) and 4 to Alzheimer's Disease (AD""]",[],"['severe focal frontal atrophy', 'executive function scores and total Theory of Mind (ToM scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",113.0,0.0375881,"The combination of the variables identified in the Group A significantly (p <0.001) discriminated between converters and nonconverters in the Group B with a sensitivity of 0.615 and a specificity of 1 (total accuracy 91.22%).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Orso', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mattei', 'Affiliation': 'Bozen Civic Hospital (Chiara Mattei), Bozen, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arnaldi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Massa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Serafini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Neurology Unit, Di Venere Hospital (Domenico Plantone), Bari, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Doglione', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Cognitive Neuroscience Laboratory, Shirley Ryan Ability Lab (Jordan Grafman), Chicago, IL.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pardini', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa (Beatrice Orso, Dario Arnaldi, Federico Massa, Gianluca Serafini, Elisa Doglione, Flavio Nobili, Matteo Pardini), Italy; Policlinico S. Martino IRCCS (Dario Arnaldi, Gianluca Serafini, Flavio Nobili, Matteo Pardini), Genova, Italy. Electronic address: matteo.pardini@unige.it.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.12.007']
682,31927162,"A randomized clinical trial of motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth: Effects on alcohol, marijuana and crimes of aggression.","BACKGROUND


Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT) has been used to reduce adolescent substance use, but has rarely been applied in youth correctional settings. This trial compared MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET) to reduce substance use and crime among incarcerated youth.
METHODS


Participants (N = 199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years). Two individual sessions of MI (or RT) were followed by 10 group sessions of CBT (or SET). Youth were randomized to condition with follow-ups at 3- and 6-months after release. Major outcomes included alcohol, marijuana and crimes involving aggression.
RESULTS


A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months. A significant treatment by time interaction was found for alcohol-related predatory aggression, with follow-up tests indicating fewer youth engaged in this behavior from 3 to 6 months within RT/SET, and weak evidence favoring MI/CBT over RT/SET at 3 months. General predatory aggression decreased from 3 to 6-months for both treatments.
CONCLUSIONS


Although weak evidence was found favoring MI/CBT with respect to alcohol-related predatory aggression, results generally support RT/SET in reducing percent heavy drinking days.",2020,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","['Participants (N\u202f=\u202f199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years']","['MI (or RT', 'Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT', 'motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth', 'MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET']","['alcohol, marijuana and crimes involving aggression', 'General predatory aggression']","[{'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C3146221', 'cui_str': 'Juvenile (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0213278,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","[{'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Department of Psychology, The University of Rhode Island, 130 Flagg Road, Kingston, RI 02881, United States; Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States; Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States. Electronic address: larstein@uri.edu.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Clair-Michaud', 'Affiliation': 'Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lebeau', 'Affiliation': 'Rhode Island Executive Office of Health & Human Services, 3 West Road, Cranston, RI 02920, United States.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Hurlbut', 'Affiliation': 'Administration of Justice, Salve Regina University, 100 Ochre Street, Newport, RI 02840, United States.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Damaris', 'Initials': 'D', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107774']
683,31927647,"""Comparative study between the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and both types in treatment of keratosis pilaris"".","The aim of this study was to assess and compare the efficacy of fractional CO2 laser, Q-switched Nd:YAG laser (1064 nm), and their combined use in treatment of keratosis pilaris. The study included twenty female patients. For each patient, three areas were randomly assigned to treatment by either fractional CO2 laser (area A) or Q-switched laser (1064 nm) (area C), or both types of laser (area B). All patients were assessed by digital photography at baseline and 1 month after the last session. Assessment was done by two non-blinded and two blinded investigators (blinded investigators do not know which area is treated with which machine and non-blinded knows). Patients reported the degree of satisfaction or any adverse effects also after 1 month from the last session. The three treatment modalities led to overall improvement in the KP lesions. According to patients' score and investigator two, area B showed statistically significant improvement compared to areas A and C (p=0.001 and p=0.039, respectively). The first blinded investigators' assessment revealed that there was statistically significant improvement in area C compared to A and B (p = 0.023). The assessment of both investigator one and the second blinded investigator revealed that there was improvement in the three areas with no statistically significant difference between them. Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.",2020,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"['twenty female patients', 'keratosis pilaris']","['fractional CO2 and Q-switched Nd:YAG laser', 'fractional CO2 laser (area A) or Q-switched laser', 'fractional CO2 laser, Q-switched Nd:YAG laser']",['degree of satisfaction or any adverse effects'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}]","[{'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",20.0,0.0294406,Both fractional CO2 and Q-switched Nd:YAG laser (1064 nm) proved to be safe and effective in the treatment of keratosis pilaris regarding not only pigmentation but also follicular prominence; their combination may have an additive effect.,"[{'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Sobhi', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt. sobhirehab@yahoo.com.'}, {'ForeName': 'Nada Adel Hassan', 'Initials': 'NAH', 'LastName': 'Adawy', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}, {'ForeName': 'Iman Sany', 'Initials': 'IS', 'LastName': 'Zaky', 'Affiliation': 'Kasr El Aini Cairo University Hospital, Cairo, Egypt.'}]",Lasers in medical science,['10.1007/s10103-020-02956-w']
684,30848033,Gastrin analogue administration adds no significant glycaemic benefit to a glucagon-like peptide-1 receptor agonist acutely or after washout of both analogues.,"AIM


To determine if a 4-week course of 14 mg weekly GLP-1 agonist LY2428757 combined with 3 mg or 2 mg daily gastrin analogue TT223 (LY+TT223) results in long-term glycaemic changes.
MATERIALS AND METHODS


Patients with in adequately-controlled type 2 diabetes mellitus ±metformin (N=151) were randomized to a 4-week course of LY+TT223 (3 mg), LY+TT223 (2 mg), LY+TT223 placebo (LY-only) or LY placebo+TT223 placebo (placebo). The primary objective was change in HbA1c from baseline to 5 month safter completion of therapy (i.e. at 6 months) and safety and tolerability with LY+TT223 versus LY-only.
RESULTS


LY groups showed HbA1c reductions during the active treatment phase. These did not persist during follow-up phase. Combining TT223 with LY did not result in additional glycaemic effects during treatment or follow-up. At 6 months, LSM ± SE for change in HbA1c from baseline was: LY+TT223 (3 mg): -0.1 ± 0.2%; LY+TT223 (2 mg): 0.1 ± 0.2%; LY-only: -0.2 ± 0.2%; placebo: 0.04 ± 0.2%. Secondary analyses were consistent with primary results. LY+TT223 was not superior to LY for other time points or end points, including insulin secretory response to mixed meal tolerance tests. The most common adverse events (nausea and vomiting) were more frequent with LY+TT223 versus LY-only. The safety profile was consistent with previous findings.
CONCLUSION


GLP-1+gastrin combination therapy did not improve glycaemic control versus GLP-1 alone.",2019,"LY+TT223 was not superior to LY for other time points or end points, including insulin secretory response to mixed meal tolerance tests.",['Patients with in adequately-controlled type 2 diabetes mellitus ±metformin (N=151'],"['placebo', 'Gastrin analogue administration', 'LY+TT223 placebo (LY-only) or LY placebo+TT223 placebo (placebo', 'GLP-1 agonist LY2428757 combined with 3 mg or 2 mg daily gastrin analogue TT223 (LY+TT223', 'GLP-1+gastrin combination therapy']","['safety and tolerability', 'insulin secretory response to mixed meal tolerance tests', 'HbA1c reductions', 'additional glycaemic effects', 'adverse events (nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376180', 'cui_str': 'Gastrin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",151.0,0.151217,"LY+TT223 was not superior to LY for other time points or end points, including insulin secretory response to mixed meal tolerance tests.","[{'ForeName': 'Krister', 'Initials': 'K', 'LastName': 'Bokvist', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Landschulz', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Sinha', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pastrak', 'Affiliation': 'Clinical Development, Transition Therapeutics ULC - OPKO Subsidiary, Toronto, Canada.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Belin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13695']
685,31504694,High-Dose Neonatal Vitamin A Supplementation Transiently Decreases Thymic Function in Early Infancy.,"BACKGROUND


Vitamin A deficiency (VAD) impairs T-cell-mediated immunity. In regions where VAD is prevalent, vitamin A supplementation (VAS) reduces child mortality, perhaps by improving immune function.
OBJECTIVE


Our objective was to determine if neonatal VAS would improve thymic function in Bangladeshi infants, and to determine if such effects differed by sex or nutritional status (i.e., birth weight above/below the median).
METHODS


Three hundred and six infants were randomly assigned to 50,000 IU vitamin A (VA) or placebo (PL) within 48 h of birth. Primary outcomes were measured at multiple ages and included 1) thymic index (TI) at 1, 6, 10, and 15 wk; 2) T-cell receptor excision circles (TREC), an index of thymic output of naïve T cells; and 3) total/naïve T cells in peripheral blood at 6 wk, 15 wk, and 2 y. A mixed linear model for repeated measures was used to assess group differences at each age and identify interactions with sex and birth weight.
RESULTS


VAS did not significantly (P = 0.21) affect TI overall (i.e., at all ages) but decreased TI by 7.8% (P = 0.029) at 6 wk: adjusted TI means for the PL and VA groups at 1, 6, 10, and 15 wk were 4.09 compared with 3.80 cm2, 7.78 compared with 7.18 cm2, 8.11 compared with 7.84 cm2, and 7.91 compared with 7.97 cm2, respectively. VAS did not significantly (P = 0.25) affect TREC overall but decreased TREC by 19% (P = 0.029) at 15 wk: adjusted TREC means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 13.6 compared with 16.1 copies/pg DNA, 19.4 compared with 15.7 copies/pg DNA, and 11.8 compared with 10.0 copies/pg DNA, respectively. VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092) T cells: adjusted naïve T-cell means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 3259 compared with 3109 cells/µL, 3771 compared with 3487 cells/µL, and 1976 compared with 1898 cells/µL, respectively.
CONCLUSION


In contrast to our hypothesis, VAS decreased thymic function early in infancy but health effects are presumably negligible owing to the transience and small magnitude of this effect. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.",2020,VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092),"['Three hundred and six infants', 'Bangladeshi infants']","['High-Dose Neonatal Vitamin A Supplementation', '50,000 IU vitamin A (VA) or placebo (PL', 'VAS', 'vitamin A supplementation (VAS']","['TREC overall but decreased TREC', 'VAS', 'TI overall', 'multiple ages and included 1) thymic index (TI) at 1, 6, 10, and 15 wk; 2) T-cell receptor excision circles (TREC), an index of thymic output of naïve T cells; and 3) total/naïve T cells in peripheral blood']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}]",306.0,0.421347,VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092),"[{'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'M Nazmul', 'Initials': 'MN', 'LastName': 'Huda', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md J', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Monirujjaman', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Taslima', 'Initials': 'T', 'LastName': 'Akhter', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Wagatsuma', 'Affiliation': 'Department of Clinical Trials and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Immunobiology, Nutrition, and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Zerofsky', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz193']
686,31951260,Effectiveness of an Evidence-Based Amputee Rehabilitation Program: A Pilot Randomized Controlled Trial.,"BACKGROUND


Despite the prevalence of lower limb amputation (LLA), only a small percentage of people with LLA actually receive physical therapy post amputation and are rehabilitated to their full potential level of function. There is a need for the development of a rehabilitation program that targets impairments and limitations specific to people with LLA.
OBJECTIVE


The objective of this study was to determine whether the Evidence-Based Amputee Rehabilitation program would improve functional mobility of people with unilateral transtibial amputation (TTA) who have already completed physical therapy and prosthetic training.
DESIGN


This study was a randomized, wait-list control, single-blinded pilot clinical trial.
SETTING


This study researched participants who had received postamputation rehabilitation to varying degrees, either in an inpatient and/or outpatient settings.
PARTICIPANTS


The participants in this study included veterans and nonveterans with unilateral TTA due to dysvascular disease and trauma.
INTERVENTION


This study included a prescription-based rehabilitation program for people with amputations.
MEASUREMENTS


Results were measured with The Amputee Mobility Predictor with (AMPPro) and without a prosthesis (AMPnoPro) and 6-Minute Walk Test (6MWT) at baseline and at the end of the 8-week intervention.
RESULTS


The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m). The effect size for the intervention was very large (1.32). In contrast, the wait-list control group demonstrated no change in AMPPro scores (35.3 to 35.6), AMPnoPro scores (24.7 to 25.0), and 6MWT distance (262.6 m to 268.8 m).
LIMITATIONS


The sample size was small. A total 326 potential candidates were screened with 306 unable to meet inclusion criteria or unwilling to participate.
CONCLUSION


People with unilateral TTA who received Evidence-Based Amputee Rehabilitation program demonstrated significant improvement in functional mobility, with most participants (66.7%) improved at least 1 K-level (58.3%) and greater than the minimal detectable change (66.7%).",2020,"The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m).The effect size for the intervention was very large (1.32).","['participants who had received post amputation rehabilitation to varying degrees, either in an inpatient and/or outpatient settings', 'people with unilateral transtibial amputation (TTA) who have already completed physical therapy and prosthetic training', 'Three-hundred twenty-six potential candidates were screened with 306 unable to meet inclusion criteria or unwilling to participate', 'The participants in this study included veterans and non-veterans with unilateral TTA due to dysvascular disease and trauma', 'people with amputations']","['prescription-based rehabilitation program', 'Evidence-Based Amputee Rehabilitation (EBAR) program', 'EBAR program', 'Evidence-Based Amputee Rehabilitation (EBAR) Program']","['6MWT distance', 'functional mobility', 'AMPnoPro scores', 'Amputee Mobility Predictor with (AMPPro) and without a prosthesis (AMPnoPro) and 6-minute Walk Test (6MWT', 'AMPnoro scores', 'AMPPro scores']","[{'cui': 'C0204095', 'cui_str': 'Post-amputation rehabilitation (regime/therapy)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",306.0,0.112927,"The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m).The effect size for the intervention was very large (1.32).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gailey', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Gaunaurd', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Raya', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'Kirk-Sanchez', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Prieto-Sanchez', 'Affiliation': 'North Florida Regional Thyroid Center, Tallahassee, Florida.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Roach', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}]",Physical therapy,['10.1093/ptj/pzaa008']
687,31483187,Increased Likelihood of Pregnancy Using an App-Connected Ovulation Test System: A Randomized Controlled Trial.,"Background:  Women trying to conceive are increasingly using fertility-tracking software applications to time intercourse. This study evaluated the difference in conception rates between women trying to conceive using an application-connected ovulation test system, which measures urinary luteinizing hormone and an estrogen metabolite, versus those trying without using ovulation testing.  Materials and Methods:  This home-based study involved 844 volunteers aged 18-40 years seeking to conceive. Volunteers randomized to the test arm were required to use the test system for the duration of the study while those randomized to the control arm were instructed not to use ovulation testing. Pregnancy rate differences across one and two cycles between the two groups were examined.  Results:  Volunteers in the test ( n  = 382) and control arms ( n  = 403) had similar baseline demographics. The proportion of women pregnant after one cycle was significantly greater in the test arm (25.4%) compared with the control arm (14.7%;  p  < 0.001). After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%;  p  = 0.026). In the test arm, volunteers had intercourse less frequently per cycle compared with those not using ovulation testing (9 [range: 1-60] vs. 10 [range: 1-50];  p  = 0.027), but were more likely to target intercourse to a particular part of their cycle compared with those not using ovulation testing (88.5% vs. 57.8%;  p  < 0.001).  Conclusion:  Using the test system to time intercourse within the fertile window increases the likelihood of conceiving within two menstrual cycles.",2020,"After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%;  p  = 0.026).","['Results:  Volunteers in the test ( n \u2009=\u2009382) and control arms ( n \u2009=\u2009403) had similar baseline demographics', '844 volunteers aged 18-40 years seeking to conceive']",[],"['conception rates', 'Pregnancy rate differences']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",844.0,0.0908595,"After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%;  p  = 0.026).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Stanford', 'Affiliation': 'Division of Public Health, Department of Family and Preventive Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Warren', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bench-Capon', 'Affiliation': 'Clinical Research Department, SPD Development Company Ltd., Bedford, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zinaman', 'Affiliation': 'Department of Obstetrics and Gynecology, Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7850']
688,31755431,To compare intralesional and oral propranolol for treating periorbital and eyelid capillary hemangiomas.,"Purpose


A pilot randomized control trial to compare the efficacy and side effects of intralesional and oral propranolol in periorbital and eyelid capillary hemangiomas.
Methods


Twenty patients were prospectively randomized to two groups of ten each. Group 1 was initiated on oral propranolol 1 mg/kg/day titrated to final dose of 3 mg/kg/day over 1 week which was continued for 6 months and then tapered over 1 week; Group 2 received 3 doses of direct intralesional propranolol hydrochloride 1 mg/ml; 0.2 ml/cm 4-6 weeks apart. Hemangioma area and corneal astigmatism were measured.
Results


Within each group at 6 months there was a significant reduction in area (group 1: 83.48 ± 11.67%,P= 0.0019; group 2: 67.78 ± 21.71%,P= 0.0019) and improvement in astigmatism (pre, post: group 1: 2.98D @ 179.8°, 1.13D @ 179.8°,P= 0.0045; group 2: 1.62D @ 90.16°, 0.75D @ 179.9°,P= 0.0001). There was no difference in area reduction (P = 0.056), change in appearance (P = 0.085), ptosis (P = 0.23) and side effects (lethargy, poor feeding;P= 0.171) between the two groups.
Conclusion


Efficacy and side effects with intralesional propranolol are comparable to oral propranolol for periorbital and eyelid lesions.",2019,"There was no difference in area reduction (P = 0.056), change in appearance (P = 0.085), ptosis (P = 0.23) and side effects (lethargy, poor feeding;P= 0.171) between the two groups.
","['periorbital and eyelid lesions', 'Methods\n\n\nTwenty patients']","['intralesional and oral propranolol', 'oral propranolol', 'propranolol', 'intralesional propranolol', 'direct intralesional propranolol hydrochloride']","['ptosis', 'area reduction', 'change in appearance', 'Hemangioma area and corneal astigmatism']","[{'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0282321', 'cui_str': 'Propranolol Hydrochloride'}]","[{'cui': 'C0005745', 'cui_str': 'Ptosis, Eyelid'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}]",20.0,0.0386051,"There was no difference in area reduction (P = 0.056), change in appearance (P = 0.085), ptosis (P = 0.23) and side effects (lethargy, poor feeding;P= 0.171) between the two groups.
","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi; Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Bajaj', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Pushker', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Bhavna', 'Initials': 'B', 'LastName': 'Chawla', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Pujari', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sartaj S', 'Initials': 'SS', 'LastName': 'Grewal', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi; Department of Ophthalmology, Grewal Eye Institute, Chandigarh, India.'}, {'ForeName': 'Satinder Pal Singh', 'Initials': 'SPS', 'LastName': 'Grewal', 'Affiliation': 'Department of Ophthalmology, Grewal Eye Institute, Chandigarh, India.'}, {'ForeName': 'Simar Rajan', 'Initials': 'SR', 'LastName': 'Singh', 'Affiliation': 'Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Kishore', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neha Singh', 'Initials': 'NS', 'LastName': 'Yadav', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_59_19']
689,31744812,Wholegrain Particle Size Influences Postprandial Glycemia in Type 2 Diabetes: A Randomized Crossover Study Comparing Four Wholegrain Breads.,"OBJECTIVE


Wholegrain foods vary in the extent of processing. We investigated whether wholegrain particle size in bread influences postprandial glycemia in type 2 diabetes.
RESEARCH DESIGN AND METHODS


Postprandial glycemia (incremental area under the blood glucose curve [iAUC]) was measured after consumption of three breads made with roller-milled wholegrain flour and added grains and a fourth made with stone-ground flour. All flours and grains were 100% wholegrain wheat. Breads were nutrient matched.
RESULTS


Fifteen adults (64 ± 10 years, HbA 1c  58 ± 13 mmol/mol) completed the study. iAUC for the three breads made with roller-milled flour ranged from 376 to 641 mmol -1 min -1 , inverse linear trend for grain particle size  P  = 0.039. The iAUC for stone-ground wholegrain bread (503) was smaller than predicted from mean particle size.
CONCLUSIONS


Wholegrain structural integrity in bread is a determinant of glycemic response. These findings have implications for dietary advice and the definition of the term ""'wholegrain.""",2020,"The iAUC for stoneground wholegrain bread (503) was smaller than predicted from mean particle size.
","['type 2 diabetes', 'Type 2 Diabetes', 'Fifteen adults (64 ± 10 years, HbA 1c  58 ± 13 mmol/mol) completed the study']","['Wholegrain Particle Size', 'three breads made with roller-milled wholegrain flour and added grains and a fourth made with stoneground flour', 'wholegrain particle size in bread']",['Postprandial glycemia (incremental area under the blood glucose curve [iAUC'],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C1211818', 'cui_str': 'Rollers'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",15.0,0.0261251,"The iAUC for stoneground wholegrain bread (503) was smaller than predicted from mean particle size.
","[{'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand andrew.reynolds@otago.ac.nz.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Elbalshy', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Mete', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Indrawati', 'Initials': 'I', 'LastName': 'Oey', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Silcock', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Nerida', 'Initials': 'N', 'LastName': 'Downes', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Perry', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Te Morenga', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}]",Diabetes care,['10.2337/dc19-1466']
690,31920295,Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD: A Subgroup Analysis of the KRONOS Study.,"Background


KRONOS, a Phase III, multicenter, randomized, double-blind study (NCT02497001) conducted in Canada, China, Japan, and the USA, assessed the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI), a triple fixed-dose combination therapy, relative to dual therapies in patients with moderate-to-very severe COPD. Here we present findings from the Japanese subgroup of KRONOS.
Methods


Patients received BGF MDI 320/18/9.6μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12μg twice-daily for 24 weeks. The primary endpoint was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) over Weeks 12-24. Symptoms, quality of life, exacerbations, and safety were also assessed.
Results


In total, 416 Japanese patients (21.9% of the global KRONOS population) were randomized and treated with BGF MDI (n=139), GFF MDI (n=138), BFF MDI (n=70), or BUD/FORM DPI (n=69). Nominally significant improvements in the change from baseline in morning pre-dose trough FEV 1  over Weeks 12-24 were observed for BGF MDI vs GFF MDI (least squares mean [LSM] difference 37 mL, 95% confidence interval [CI] 3, 72;  P =0.0337) and BFF MDI (67 mL; 95% CI 25, 109;  P =0.0020). Treatment with BGF MDI led to a nominally significant reduction in the rate of moderate/severe exacerbations vs GFF MDI (rate ratio 0.40, 95% CI 0.19, 0.83;  P =0.0142). Compared with dual therapies, numerical improvements were observed with BGF MDI for Transition Dyspnea Index focal score and the change from baseline in Evaluating Respiratory Symptoms in COPD total score ( P ≤0.3899). All treatments were generally well tolerated.
Conclusion


BGF MDI nominally significantly improved lung function and numerically improved symptoms vs GFF MDI and BFF MDI. BGF MDI nominally significantly reduced exacerbations vs GFF MDI in Japanese patients with COPD. Efficacy and safety findings were generally comparable to those in the global KRONOS population.",2019,"Conclusion


BGF MDI nominally significantly improved lung function and numerically improved symptoms vs GFF MDI and BFF MDI.","['416 Japanese patients (21.9% of the global KRONOS population', 'Japanese Patients with COPD', 'patients with moderate-to-very severe COPD', 'Japanese subgroup of KRONOS', 'Japanese patients with COPD']","['BGF MDI 320/18/9.6μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI', 'BFF MDI (n=70), or BUD/FORM DPI', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'BGF MDI', 'GFF MDI', 'budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI']","['BGF MDI for Transition Dyspnea Index focal score', 'BFF MDI', 'efficacy and safety', 'rate of moderate/severe exacerbations vs GFF MDI', 'tolerated', 'lung function', 'Efficacy and safety findings', 'COPD total score', 'Efficacy and Safety', 'change from baseline in morning pre-dose trough forced expiratory volume', 'Symptoms, quality of life, exacerbations, and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}]","[{'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C3853847', 'cui_str': 'Dry Powder Inhaler'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0581560', 'cui_str': 'Safety finding'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",416.0,0.449295,"Conclusion


BGF MDI nominally significantly improved lung function and numerically improved symptoms vs GFF MDI and BFF MDI.","[{'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Ichinose', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fukushima', 'Affiliation': 'Department of Internal Medicine, Fukuwa Clinic, Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hataji', 'Affiliation': 'Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Takikawa', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bourne', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S220850']
691,31920296,Long-Term Safety and Efficacy of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD.,"Background


Budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) is a triple fixed-dose combination for COPD. The long-term safety of triple therapy for COPD has not been investigated in Japanese patients. In this 28-week extension study (NCT03262012), we investigated the long-term safety and tolerability of BGF MDI in Japanese patients with moderate-to-very severe COPD who completed the 24-week Phase III randomized, double-blind, multicenter KRONOS study (NCT02497001).
Materials and methods


Patients randomized to BGF MDI 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice-daily in KRONOS continued treatment for up to 28 additional weeks. Safety was evaluated over 52 weeks via adverse event (AE) monitoring, electrocardiograms, clinical laboratory testing, and vital sign measurements.
Results


The safety population included 416 patients who received BGF MDI (n=139), GFF MDI (n=138), BFF MDI (n=70), or BUD/FORM DPI (n=69). Treatment-emergent AE (TEAE) rates were similar across treatment groups (range: 82.6-82.9%). The most frequent TEAEs overall were nasopharyngitis (32.2%) and bronchitis (9.9%). The incidence of major adverse cardiovascular events was low across groups (range: 0.0-2.9%). Over 52 weeks, the incidence of confirmed pneumonia was 9.4% (BGF MDI), 3.6% (GFF MDI), 5.7% (BFF MDI), and 2.9% (BUD/FORM DPI); in the 28-week extension period, rates were comparable across groups (range: 2.9-5.7%). Six deaths were reported (0.7-2.2% per group); none were considered treatment-related. No clinically meaningful trends were observed in electrocardiograms, laboratory parameters, or vital signs over time in any of the treatment groups.
Conclusion


All treatments were well tolerated over 52 weeks, and the safety profile of BGF MDI was generally comparable to dual long-acting muscarinic antagonist (LAMA)/long-acting β 2 -agonist (LABA) and inhaled corticosteroid (ICS)/LABA therapies. These findings support the long-term tolerability of BGF MDI in Japanese patients with COPD.",2019,"No clinically meaningful trends were observed in electrocardiograms, laboratory parameters, or vital signs over time in any of the treatment groups.
","['Japanese Patients with COPD', 'Japanese patients with moderate-to-very severe COPD', 'Japanese patients', 'n=138), BFF MDI (n=70), or BUD/FORM DPI (n=69', '416 patients who received', 'Japanese patients with COPD']","['budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'BGF MDI', 'GFF MDI', 'Budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI', 'glycopyrrolate/formoterol fumarate (GFF']","['incidence of confirmed pneumonia', 'adverse event (AE) monitoring, electrocardiograms, clinical laboratory testing, and vital sign measurements', 'Treatment-emergent AE (TEAE) rates', 'nasopharyngitis', 'safety profile of BGF MDI', 'Safety', 'electrocardiograms, laboratory parameters, or vital signs over time', 'incidence of major adverse cardiovascular events', 'bronchitis', 'Six deaths']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505475', 'cui_str': 'Clinical Laboratory Testings'}, {'cui': 'C2963216'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518766'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",416.0,0.173214,"No clinically meaningful trends were observed in electrocardiograms, laboratory parameters, or vital signs over time in any of the treatment groups.
","[{'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Ichinose', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fukushima', 'Affiliation': 'Department of Internal Medicine, Fukuwa Clinic, Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hataji', 'Affiliation': 'Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Großhansdorf, Germany.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Takikawa', 'Affiliation': 'AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bourne', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'Formerly of AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S220861']
692,31943761,The effect of a combined intervention on exclusive breastfeeding in primiparas: A randomised controlled trial.,"An antenatal/postnatal intervention involving proactive telephone support and written materials was conducted among primiparas. Four hundred women, from the Split-Dalmatia County, Croatia, were randomized between November 2013 and December 2016 into three groups: intervention (IG), active control (ACG) and standard care (SCG). Primary outcome was exclusive breastfeeding (EBF) at 3 months. Secondary outcomes included breastfeeding difficulties, attitudes towards infant feeding, breastfeeding self-efficacy and social support. Practice staff were blinded to group allocation. Of 400 women, 45 (11%) were lost to follow-up, and final analyses were conducted on 129 (IG), 103 (ACG) and 123 (SCG) participants. EBF rates at 3 months were significantly higher for the IG (odds ratio [OR] 4.6, 95% confidence interval [CI], 2.7 to 8.1; EBF 81%) as well as at 6 months (OR 15.7, 95% CI, 9.1 to 27.1; EBF 64%) compared with SCG (EBF 47% at 3 months and 3% at 6 months). Higher rates were also observed for the ACG at 3 months (OR 2.2, 95% CI, 1.3 to 3.8, EBF 68%) and 6 months (OR 2.3, 95% CI, 1.4 to 3.9, EBF 16%). Participants in the IG had the highest increase in positive attitudes towards infant feeding, in comparison to baseline, and significantly higher breastfeeding self-efficacy. Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs. Written breastfeeding materials and proactive telephone support among primiparas are an effective means of increasing breastfeeding rates, decreasing breastfeeding difficulties and improving self-efficacy and attitudes towards infant feeding.",2020,"Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs.","['primiparas', 'Four hundred women, from the Split-Dalmatia County, Croatia, were randomized between November 2013 and December 2016 into three groups', 'Of 400 women, 45 (11%) were lost to follow-up, and final analyses were conducted on 129 (IG), 103 (ACG) and 123 (SCG) participants']","['proactive telephone support and written materials', 'intervention (IG), active control (ACG) and standard care (SCG', 'combined intervention']","['exclusive breastfeeding (EBF', 'positive attitudes towards infant feeding', 'breastfeeding difficulties', 'breastfeeding difficulties, attitudes towards infant feeding, breastfeeding self-efficacy and social support', 'breastfeeding self-efficacy', 'EBF rates', 'breastfeeding difficulties and improving self-efficacy and attitudes towards infant feeding']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn Sodium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding (finding)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",400.0,0.0732465,"Participants in SCG experienced significantly more breastfeeding difficulties, both at 3 and 6 months, in comparison to AC and IGs.","[{'ForeName': 'Drita', 'Initials': 'D', 'LastName': 'Puharić', 'Affiliation': 'Postgraduate Doctoral Program ""TRIBE,"" School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Malički', 'Affiliation': 'Department of Research in Biomedicine and Health, Department of Medical Humanities, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Josip Anđelo', 'Initials': 'JA', 'LastName': 'Borovac', 'Affiliation': 'Department of Pathophysiology, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Šparac', 'Affiliation': 'Medical Centre ""Šparac"", Split, Croatia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Poljak', 'Affiliation': '""Cito"" Medical Centre, Split, Croatia.'}, {'ForeName': 'Nađa', 'Initials': 'N', 'LastName': 'Aračić', 'Affiliation': '""Cito"" Medical Centre, Split, Croatia.'}, {'ForeName': 'Nero', 'Initials': 'N', 'LastName': 'Marinović', 'Affiliation': 'Split-Dalmatiani County Health Department, Omiš, Croatia.'}, {'ForeName': 'Nives', 'Initials': 'N', 'LastName': 'Luetić', 'Affiliation': 'Split-Dalmatian County Health Department, Split, Croatia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'Departments of Clinical Skills and Family Medicine, School of Medicine, University of Split, Split, Croatia.'}]",Maternal & child nutrition,['10.1111/mcn.12948']
693,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
694,31926883,Long-term Results of Trimethoprim-Sulfamethoxazole Versus Placebo to Reduce the Risk of Recurrent Toxoplasma gondii Retinochoroiditis.,"PURPOSE


To compare the effects of 1 year of treatment with trimethoprim-sulfamethoxazole (TMP-SMZ) vs placebo in reducing the risk of recurrence of toxoplasmic retinochoroiditis during a 6-year follow-up period.
DESIGN


Randomized, double-masked clinical trial.
METHODS


This cohort included 141 subjects recruited in Campinas, Brazil. The inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All subjects were treated with 1 dose of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, subjects were randomly assigned to group 1 (1 TMP-SMZ dose every other day for 311 days) or group 2 (1 identical placebo tablet containing starch with no active ingredients every other day for 311 days). Between the second and sixth years of follow-up appointments, none of the subjects received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis in the 6 years of follow-up.
RESULTS


The cumulative probability of recurrence 1, 2, 3, 4, 5, and 6 years after the initial infection was, respectively, 13.0% (9/69), 17.4% (12/69), 20.3% (14/69), 23.2% (16/69), 26.1% (18/69), and 27.5% (19/69) in the placebo group and 0%, 0%, 0%, 0%, 0%, and 1.4% (1/72) in the TMP-SMZ group (P < .001; log-rank test). There were 3 cases (3/69; 4.3%) of multiple recurrences in the same individual in the placebo group. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female subjects.
CONCLUSIONS


TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.",2020,No treatment-limiting toxicity or side effects were observed in either group.,"['female subjects', '141 subjects recruited in Campinas, Brazil']","['trimethoprim-sulfamethoxazole (TMP-SMZ', 'placebo tablet containing starch with no active ingredients', 'trimethoprim-sulfamethoxazole', 'placebo', 'TMP-SMZ']","['cumulative probability of recurrence', 'risk of recurrent Toxoplasma gondii retinochoroiditis', 'toxicity or side effects', 'unilateral active recurrent toxoplasmic retinochoroiditis', 'risk of recurrence of toxoplasmic retinochoroiditis', 'recurrent toxoplasmic retinochoroiditis within the first year of follow up and recurrent toxoplasmic retinochoroiditis']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040557', 'cui_str': 'Toxoplasma gondii'}, {'cui': 'C0008513', 'cui_str': 'Chorioretinitis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",141.0,0.225952,No treatment-limiting toxicity or side effects were observed in either group.,"[{'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Fernandes Felix', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil. Electronic address: joaopaulofelix@hotmail.com.'}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil; Federal University of Pernambuco (UFPE), Recife, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Hermano Lucio Gomes de', 'Initials': 'HLG', 'LastName': 'Assis Filho', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alexandre Brito', 'Initials': 'AB', 'LastName': 'Cosimo', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mauricio Abujamra', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.025']
695,31621175,A randomized trial comparing bipolar transurethral vaporization of the prostate with GreenLight laser (xps-180watt) photoselective vaporization of the prostate for treatment of small to moderate benign prostatic obstruction: outcomes after 2 years.,"OBJECTIVE


To test the non-inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia-related lower urinary tract symptoms in a randomized trial.
METHODS


Eligible patients with prostate volumes of 30-80 mL were randomly allocated to GL-PVP (n = 58) or bipolar TUVP (n = 61). Non-inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri-operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post-void residual urine volume) and sexual (International Index of Erectile Function-15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources-related costs of both procedures were recorded and compared.
RESULTS


Baseline and peri-operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL-PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval -0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25-99)% and 65.9 (50-99)% (P = 0.006) after GL-PVP, and 32.1 (28.6-89.7)% and 39.3 (68.8-90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL-PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL-PVP procedure after 24 months (P = 0.01).
CONCLUSIONS


In terms of symptom control, bipolar TUVP was not inferior to GL-PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL-PVP compared with bipolar TUVP is an important concern.",2020,The mean estimated cost per B.TUVP procedure was significantly lower than per GL.PVP procedure after 24 months (P=0.01),"['Eligible patients with 30-80ml prostate', 'small to moderate Benign Prostatic Obstruction']","['Greenlight laser (GL.PVP) vaporization', 'GL.PVP', 'GL.PVP/XPS TM  (58) and B.TUVP', 'Bipolar (B.TUVP', 'Bipolar Transurethral Vaporization of the Prostate versus GreenLight Laser (XPS-180Watt) Photoselective Vaporization']","['recurrent BOO', 'Urinary (IPSS, Q.max and PVR) and sexual (IIEF-15) outcome measures', 'mean estimated cost per B.TUVP procedure', 'Mean IPSS', 'IPSS', 'Median postoperative PSA reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction (disorder)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0846611,The mean estimated cost per B.TUVP procedure was significantly lower than per GL.PVP procedure after 24 months (P=0.01),"[{'ForeName': 'Fady K', 'Initials': 'FK', 'LastName': 'Ghobrial', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shoma', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nasr', 'Initials': 'N', 'LastName': 'El-Tabey', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Nabeeh', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.14926']
696,30193564,Impact of telemedicine on the clinical outcomes and healthcare costs of patients with chronic heart failure and mid-range or preserved ejection fraction managed in a multidisciplinary chronic heart failure programme: A sub-analysis of the iCOR randomized trial.,"Background


The efficacy of telemedicine in the management of patients with chronic heart failure and left ventricular ejection fraction ≥40% is poorly understood. The aim of our analysis was to evaluate the efficacy of a telemedicine-based intervention specifically in these patients, as compared to standard of care alone.
Methods


The Insuficiència Cardiaca Optimització Remota (iCOR) study was a single centre, randomised, controlled trial, designed to evaluate a telemedicine intervention added to an existing hospital/primary care multidisciplinary, integrated programme for chronic heart failure patients. 178 participants were randomised to telemedicine or usual care, and were followed for six months. For the present sub-analysis, only iCOR participants (n = 116) with left ventricular ejection fraction ≥40% were included. The primary study endpoint was the incidence of an acute non-fatal heart failure event, defined as a new episode of worsening of symptoms and signs consistent with acute heart failure requiring intravenous diuretic therapy. The healthcare-related costs in each study group were also evaluated.
Results


The incidence of the first occurrence of the primary endpoint was significantly lower in the telemedicine arm (22% vs 56%, p<0.001), with a hazard ratio of 0.33 comparing to the usual care arm (95% confidence interval 0.17–0.64). Telemedicine was also associated with lower mean overall chronic heart failure care-related costs compared to usual care (8163€ vs 4993€, p=0.001). The results were consistent in both left ventricular ejection fraction of 40–49% and left ventricular ejection fraction ≥50% patients.
Conclusions


Our results suggest that telemedicine is a promising strategy for the management of chronic heart failure patients with left ventricular ejection fraction ≥40%. These findings should be replicated in larger cohorts.",2020,The results were consistent in both left ventricular ejection fraction of 40-49% and left ventricular ejection fraction ≥50% patients.,"['178 participants', 'iCOR participants (n\u2009=\u2009116) with left ventricular ejection fraction ≥40% were included', 'chronic heart failure patients with left ventricular ejection fraction ≥40', 'patients with chronic heart failure and mid-range or preserved ejection fraction managed in a multidisciplinary chronic heart failure programme', 'patients with chronic heart failure and left ventricular ejection fraction ≥40', 'chronic heart failure patients']","['Telemedicine', 'telemedicine or usual care', 'telemedicine', 'telemedicine intervention', 'telemedicine-based intervention']","['left ventricular ejection fraction', 'incidence of an acute non-fatal heart failure event, defined as a new episode of worsening of symptoms and signs consistent with acute heart failure requiring intravenous diuretic therapy']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]",178.0,0.0566359,The results were consistent in both left ventricular ejection fraction of 40-49% and left ventricular ejection fraction ≥50% patients.,"[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Jiménez-Marrero', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cainzos-Achirica', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Garay', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Farre', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Verdú', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Linas', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Ruiz', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Hidalgo', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calero', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18796439']
697,31578781,Does Listening to Music Regulate Negative Affect in a Stressful Situation? Examining the Effects of Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls.,"BACKGROUND


Stress and anxiety are increasingly common among young people. The current research describes two studies comparing the effects of self-selected and researcher-selected music on induced negative affect (state anxiety and physiological arousal), and state mindfulness.
METHOD


In Study 1, 70 undergraduates were randomly assigned to one of three conditions: researcher-selected music, self-selected music, or a silent control condition. In Study 2, with 75 undergraduates, effects of music were compared to an active control (listening to a radio show). Negative affect was induced using a speech preparation and arithmetic task, followed by music listening or control. Self-reported anxiety and blood pressure were measured at baseline, post-induction, and post-intervention. Study 2 included state mindfulness as a dependent measure.
RESULTS


Study 1 indicated that participants who listened to music (self-selected and researcher-selected) reported significantly greater anxiety reduction than participants in the silent control condition. Music did not reduce anxiety compared to an active control in Study 2. However, music listening significantly increased levels of state mindfulness, which predicted lower anxiety after self-selected music listening.
CONCLUSIONS


Music may provide regulation in preparation for stressful events. Yet, the results of Study 2 indicate that other activities have similar benefits, and shows, for the first time, that music listening increases mindfulness following a stressor.",2020,Music did not reduce anxiety compared to an active control in Study 2.,"['70 undergraduates', 'young people']","['Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls', 'active control (listening to a radio show', 'music listening', 'researcher-selected music, self-selected music, or a silent control condition', 'self-selected and researcher-selected music']","['Self-reported anxiety and blood pressure', 'anxiety reduction', 'anxiety', 'levels of state mindfulness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",2.0,0.0636066,Music did not reduce anxiety compared to an active control in Study 2.,"[{'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'Groarke', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'AnnMarie', 'Initials': 'A', 'LastName': 'Groarke', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hogan', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Costello', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lynch', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12185']
698,31504693,Lipolysis and Fat Oxidation Are Not Altered with Presleep Compared with Daytime Casein Protein Intake in Resistance-Trained Women.,"BACKGROUND


To date, no studies have directly compared the differences between presleep and daytime protein (PRO) consumption on localized and systemic fat metabolism in active women.
OBJECTIVE


The purpose of this study was to assess the effects of presleep compared with daytime PRO supplementation on subcutaneous abdominal adipose tissue (SCAAT) lipolysis and whole-body substrate utilization in women.
METHODS


Thirteen young (mean ± SE age: 22 ± 1 y; BMI: 24.3 ± 0.8 kg/m2), resistance-trained [1 repetition maximum (1RM) squat percentage of body weight: 135% ± 6%; 1RM bench press percentage of body weight: 82% ± 4%] women volunteered. On overnight experimental visits, participants performed full-body resistance exercise (RE; 65% 1RM) and were randomly assigned to consume either daytime PRO (PRO, 30 g casein) 30 min post-RE and presleep (30 min before bed) noncaloric, sensory-matched placebo (PLA, 0 g casein) (PRO-PLA), or the opposite (PLA-PRO), switching the order of the supplements on the following visit. SCAAT lipolysis, resting metabolism (indirect calorimetry), and plasma biomarkers (glucose, insulin, nonesterified fatty acids, glycerol) were measured at baseline, overnight, and the next morning.
RESULTS


There were no differences in overnight SCAAT lipolysis between conditions indicated by interstitial glycerol concentrations (PRO-PLA: baseline, 669 ± 137; next morning, 321 ± 77.1; PLA-PRO: baseline, 524 ± 109; next morning, 333 ± 68.0 μM), fat oxidation (PRO-PLA: baseline, 5.70 ± 0.35; next morning, 5.00 ± 0.28; PLA-PRO: baseline, 6.59 ± 0.32; next morning, 5.44 ± 0.27 g/min), or any other measure.
CONCLUSIONS


There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women. Presleep PRO is a viable option for increasing PRO consumption in resistance-trained women because it does not blunt overnight lipolysis, and will therefore likely not lead to increases in subcutaneous abdominal fat.This trial was registered at clinicaltrials.gov as NCT03573687.",2020,There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women.,"['women volunteered', 'Thirteen', 'women', 'Resistance-Trained Women', 'young (mean\xa0±\xa0SE age: 22\xa0±\xa01 y; BMI: 24.3\xa0±\xa00.8 kg/m2), resistance-trained [1 repetition maximum (1RM) squat percentage of body weight: 135%\xa0±\xa06%; 1RM bench press percentage of body weight: 82%\xa0±\xa04', 'active women']","['daytime PRO supplementation', 'noncaloric, sensory-matched placebo (PLA, 0 g casein) (PRO-PLA', 'daytime PRO (PRO, 30 g casein', 'Daytime Casein Protein Intake']","['subcutaneous abdominal adipose tissue (SCAAT) lipolysis and whole-body substrate utilization', 'SCAAT lipolysis, resting metabolism (indirect calorimetry), and plasma biomarkers (glucose, insulin, nonesterified fatty acids, glycerol', 'fat oxidation ', 'overnight SCAAT lipolysis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]",13.0,0.188794,There was no difference between the effects of daytime and presleep PRO supplementation on SCAAT lipolysis or whole-body substrate utilization in resistance-trained women.,"[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'Allman', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Jeong-Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Lynn B', 'Initials': 'LB', 'LastName': 'Panton', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Contreras', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hickner', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Institute of Sports Sciences and Medicine, Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz186']
699,31812437,An experimental study to test the efficacy of Mesenchymal Stem Cells in reducing corneal scarring in an ex-vivo organ culture model.,"In this study, we evaluated the effect of placenta-derived Mesenchymal Stem Cells (MSCs) versus placebo in improving corneal transparency following experimental injury in an ex-vivo organ culture model of post-mortem human corneas. We also compared the influence of MSCs on the basic histopathology of the cornea and the immunohistochemistry markers of fibrotic corneal scarring. Mesenchymal Stem Cells extracted from the placenta were isolated and expanded in-vitro. Five pairs of post-mortem human corneas harvested for the corneal transplant of equal grade were included in the study. Corneas of the same pair were randomly assigned to either the case arm or the control arm. All corneas underwent a standardized superficial keratectomy, 4 mm in diameter. The case and control arm corneas received an intrastromal injection of MSCs and placebo respectively. The corneal button was maintained in an organ culture system for 28 days under the standard protocol. Laser light was passed through the corneas mounted on a self-styled modified artificial anterior chamber. Image analysis was used to quantify corneal transparency. Haematoxylin & Eosin staining and Immunohistochemistry was done for Alpha SMA (Smooth Muscle Actin). Laser scatter measurements were measured using Image Analysis (Image J Software). The difference in the mean of Full-Width Half Maximum (FWHM), Max intensity and Red pixel intensity between the cases and the controls was 101.5, 16.3 and 11.4 respectively which was found to be statistically significant (P < 0.05). Histopathology showed a disorganized Bowman's layer in the controls as compared to the cases. Alpha Smooth Muscle Actin at the injury site stained 3 + in all controls as compared to 1 + in the cases, showing a statistically significant difference (p = 0.005). Based on our findings, we consider that placenta-derived Mesenchymal Stem Cells can alter evolving corneal scarring into a more favourable outcome with better corneal transparency and lesser fibrotic corneal scarring.",2020,"Alpha Smooth Muscle Actin at the injury site stained 3 + in all controls as compared to 1 + in the cases, showing a statistically significant difference (p = 0.005).",['experimental injury in an ex-vivo organ culture model of post-mortem human corneas'],"['Mesenchymal Stem Cells', 'MSCs', 'placenta-derived Mesenchymal Stem Cells (MSCs) versus placebo', 'intrastromal injection of MSCs and placebo', 'Haematoxylin & Eosin staining and Immunohistochemistry', 'Laser light']","['corneal transparency', 'mean of Full-Width Half Maximum (FWHM), Max intensity and Red pixel intensity', 'Laser scatter measurements', 'Alpha Smooth Muscle Actin', 'corneal scarring']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture Techniques'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}]","[{'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0018964', 'cui_str': 'Hydroxybrasilin'}, {'cui': 'C0014448', 'cui_str': 'eosin'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1289893', 'cui_str': 'Visible laser light (physical force)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439742', 'cui_str': 'Scattered (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1267092', 'cui_str': 'Muscle, Involuntary'}, {'cui': 'C0001271', 'cui_str': 'Actins'}]",,0.0319337,"Alpha Smooth Muscle Actin at the injury site stained 3 + in all controls as compared to 1 + in the cases, showing a statistically significant difference (p = 0.005).","[{'ForeName': 'Jeyanth Suresh', 'Initials': 'JS', 'LastName': 'Rose', 'Affiliation': 'Department of Ophthalmology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Sharmili', 'Initials': 'S', 'LastName': 'Lalgudi', 'Affiliation': 'Department of Ophthalmology, Christian Medical College, Vellore, India. Electronic address: shammi_8188@yahoo.com.'}, {'ForeName': 'Aarwin', 'Initials': 'A', 'LastName': 'Joshua', 'Affiliation': 'Centre for Stem Cell Research, Christian Medical College, Vellore, India.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Centre for Stem Cell Research, Christian Medical College, Vellore, India.'}, {'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Thambaiah', 'Affiliation': 'Centre for Stem Cell Research, Christian Medical College, Vellore, India.'}, {'ForeName': 'Syrpailyne', 'Initials': 'S', 'LastName': 'Wankhar', 'Affiliation': 'Department of Bioengineering, Christian Medical College, Vellore, India.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Chacko', 'Affiliation': 'Department of General Pathology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuriakose', 'Affiliation': 'Department of Ophthalmology, Christian Medical College, Vellore, India.'}, {'ForeName': 'Sanita', 'Initials': 'S', 'LastName': 'Korah', 'Affiliation': 'Department of Ophthalmology, Christian Medical College, Vellore, India.'}]",Experimental eye research,['10.1016/j.exer.2019.107891']
700,31410968,Clinical relevance of ticagrelor monotherapy following 1-month dual antiplatelet therapy after bifurcation percutaneous coronary intervention: Insight from GLOBAL LEADERS trial.,"BACKGROUND


The aim of this study was to investigate the impact of ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for bifurcation lesions.
METHODS


GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing 1-month DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years.
RESULTS


Among the 15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion. The incidence of the primary endpoint was similar between the bifurcation and nonbifurcation groups (4.7 vs. 4.0%, p = .083). The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
CONCLUSIONS


After PCI for bifurcation lesions using 1-month of DAPT followed by ticagrelor monotherapy for 23 months did not demonstrate explicit benefit regarding all-cause death or new Q-wave MI as in the overall trial.",2020,"The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
","['patients treated with a biolimus A9-eluting stent', '15,845 patients included in this subgroup analysis, 2,498 patients (15.8%) underwent PCI for at least one bifurcation lesion', 'bifurcation percutaneous coronary intervention']","['ticagrelor monotherapy', 'DAPT with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy']","['composite of all-cause death or new Q-wave myocardial infarction (MI) at 2\u2009years', 'definite or probable stent thrombosis', 'stroke', 'presence/absence of a bifurcation lesion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",2498.0,0.142694,"The experimental treatment had no significant effect on the primary endpoint according to the presence/absence of a bifurcation lesion (bifurcation: hazard ratio [HR]: 0.74, 95% confidence interval [CI]: 0.51-1.07; nonbifurcation: HR: 0.90, 95% CI: 0.76-1.07, p for interaction = .343), but was associated with significant reduction in definite or probable stent thrombosis (p for interaction = .022) and significant excess of stroke (p for interaction = .018) when compared with the reference treatment.
","[{'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'De Wilder', 'Affiliation': 'Heart Centre, Imelda Hospital Bonheiden, Bonheiden, Belgium.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, Villa Maria Cecila Hospital GVM, Cotignola (RA), Italy.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Louvard', 'Affiliation': 'Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'G Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials (FACT), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart and Thorax Center, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Heart Centre, Imelda Hospital Bonheiden, Bonheiden, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, London, UK.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28428']
701,31910050,"A Population-Level, Randomized Effectiveness Trial of Recruitment Strategies for Parenting Programs in Elementary Schools.","Objective : A population-level, randomized controlled trial was conducted to test the effectiveness of a parent recruitment package for increasing initial engagement into a school-based parenting program and to identify strategies responsible for effects. Method : Participants were caregivers of kindergarten- to third-grade students ( N  = 1,276) attending one of five schools serving ethnically diverse families living in mostly low-income, urban conditions. First, families were randomly assigned to be recruited for research surveys or not, and then to a parenting program recruitment condition: 1) Engagement-as-usual (EAU) informational flyer; 2) EAU + testimonial booklet; 3) EAU + teacher endorsement; 4) EAU + recruitment call; or 5) all strategies (full package). Caregivers were offered a free parenting program at their child's school. Primary dependent variables were parenting program enrollment and attending at least one session (initiation). Exploratory analyses were conducted on program completion, attendance across sessions, homework completion, and in-session participation. Results : In the population-level sample, enrollment and initiation were higher for the full package compared to all other conditions except the recruitment call condition. Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition. In the subsample of initiators, parents in the full package condition attended fewer parenting sessions than in the EAU condition. Controlling for attendance across sessions, there were no condition effects on homework completion or in-session participation. Conclusions : The recruitment call can increase the public health impact of evidence-based parenting programs by improving enrollment, initiation, and program completion.",2020,"Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition.","['Participants were caregivers of kindergarten- to third-grade students ( N  =\xa01,276) attending one of five schools serving ethnically diverse families living in mostly low-income, urban conditions', 'Parenting Programs in Elementary Schools']","['parenting program recruitment condition: 1) Engagement-as-usual (EAU) informational flyer; 2) EAU + testimonial booklet; 3) EAU + teacher endorsement; 4) EAU + recruitment call; or 5) all strategies (full package', 'parent recruitment package']",['parenting program enrollment and attending at least one session (initiation'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",1276.0,0.10721,"Enrollment, initiation, and program completion were higher for the recruitment call and full package conditions compared to the EAU condition.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Abraczinskas', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Winslow', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Oswalt', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Wolchik', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1703711']
702,31919695,Impact of Race and Ethnicity on Weight-Loss Outcomes in Pediatric Family-Based Obesity Treatment.,"INTRODUCTION


Minority children are disproportionately affected by obesity and little is known about how race/ethnicity impacts outcomes in pediatric weight-loss treatment. This study aimed to evaluate whether race/ethnicity affected weight-loss outcomes in a pediatric obesity intervention. Secondary aims included evaluating whether race/ethnicity was associated with energy intake, exercise, program adherence, acceptability, and attendance.
METHODS


One hundred fifty parent/child dyads (age 8-12 years, BMI% 85-99.9; 32% Hispanic, 24% Non-Hispanic, Non-White, 44% Non-Hispanic White) participated in a randomized control trial evaluating weight loss in family-based behavioral treatment with (FBT) or without child participation (i.e., Parent-Based Treatment, PBT). Assessments occurred at baseline, mid-treatment (month 3), post-treatment (month 6), and follow-up (months 12 and 24). Analyses included linear mixed effect models, linear models, and a negative binomial model.
RESULTS


Weight loss in Hispanic, Non-Hispanic White, and Non-Hispanic, Non-White children was not significantly different by race/ethnicity at months 6, 12, and 24 (p = 0.259) and was similar across both treatments (FBT = - 0.16 BMIz; PBT = - 0.21 BMIz; p = 0.61). There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123). However, Hispanic families attended fewer treatment visits than Non-Hispanic White families (p = 0.017).
CONCLUSION


On average, children lost weight participating in our pediatric obesity treatment and there was no statistical difference in weight loss between groups. Future research evaluating whether culturally adapted treatments would be more effective for racial/ethnic minorities or whether the personalization inherent in family-based behavioral treatment may be sufficient is needed.",2020,"There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123).","['pediatric obesity intervention', 'Weight loss in Hispanic, Non-Hispanic White, and Non-Hispanic, Non', 'One hundred fifty parent/child dyads (age 8-12\xa0years, BMI% 85-99.9; 32% Hispanic, 24% Non-Hispanic, Non-White, 44% Non-Hispanic White', 'Pediatric Family-Based Obesity Treatment']","['weight loss in family-based behavioral treatment with (FBT) or without child participation (i.e., Parent-Based Treatment, PBT']","['weight loss', 'energy intake, exercise, program adherence, acceptability, and attendance', 'energy intake, physical activity, acceptability ratings, or adherence to treatment']","[{'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517914', 'cui_str': '99.9 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0408724,"There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123).","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA. deichen@ucsd.edu.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00694-6']
703,30632140,Risankizumab vs. ustekinumab for plaque psoriasis: a critical appraisal.,"AIM


Gordon et al. investigated the efficacy and safety of risankizumab [an anti-interleukin (IL)-23p19 biologic] compared with ustekinumab (anti-IL-12/23p40) and placebo in patients with moderate-to-severe chronic plaque psoriasis. This was a parallel-group controlled study up to 16 weeks with a planned switch of the placebo group to risankizumab at 16 weeks.
SETTING AND DESIGN


This study consisted of two replicate phase III, double-blinded randomized controlled trials (UltIMMa-1 and UltIMMa-2) conducted across 139 centres in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain and the U.S.A.
STUDY EXPOSURE


Patients with a minimum 6-month history of chronic plaque psoriasis were randomly assigned to receive either 150 mg risankizumab, 45 mg or 90 mg ustekinumab or placebo. Prior to this, each group was also stratified by weight (either more than or less than 100 kg) and previous exposure to tumour necrosis factor inhibitors. Those assigned to receive placebo were transitioned onto risankizumab at week 16. The study drugs were given at weeks 0, 4, 16, 28 and 40.
OUTCOMES


The severity of psoriasis was measured using the Psoriasis Area and Severity Index (PASI) and a static Physician's Global Assessment (sPGA). The authors additionally recorded the number of adverse events in each treatment arm, and a measure of quality of life.
PRIMARY OUTCOME MEASURES


The coprimary outcomes were the proportions of patients achieving ≥ 90% reduction in their baseline PASI (PASI 90) and an sPGA score of 0 or 1 (clear or almost clear) at week 16.
RESULTS


In total 506 patients were included in UltIMMa-1 and 491 patients in UltIMMa-2. In UltIMMa-1, PASI 90 by week 16 was achieved by 75·3% of patients receiving risankizumab, compared with 42·0% receiving ustekinumab and 4·9% receiving placebo (P < 0·001 vs. placebo and ustekinumab). sPGA of 0 or 1 by week 16 was achieved by 87·6% of patients receiving risankizumab, compared with 63·0% receiving ustekinumab and 7·8% receiving placebo (P < 0·001 vs. placebo and ustekinumab). The results for UltIMMa-2 are similar. The frequencies of adverse events in the risankizumab, ustekinumab and placebo groups were similar in both studies.
CONCLUSIONS


Gordon et al. conclude that risankizumab has a higher efficacy than placebo and ustekinumab in the treatment of moderate-to-severe chronic plaque psoriasis, and that the adverse-event profiles were similar across all treatment groups.",2019,"The frequencies of adverse events in the risankizumab, ustekinumab and placebo groups were similar in both studies.
","['139 centres in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain and the U.S.A.\nSTUDY EXPOSURE\n\n\nPatients with a minimum 6-month history of chronic plaque psoriasis', 'plaque psoriasis', 'In total 506 patients were included in UltIMMa-1 and 491 patients in UltIMMa-2', 'patients with moderate-to-severe chronic plaque psoriasis']","['risankizumab [an anti-interleukin (IL)-23p19 biologic', 'ustekinumab (anti-IL-12/23p40) and placebo', 'risankizumab', 'placebo', '150 mg risankizumab, 45 mg or 90 mg ustekinumab or placebo', 'Risankizumab vs. ustekinumab']","['proportions of patients achieving ≥ 90% reduction in their baseline PASI (PASI 90) and an sPGA score of 0 or 1 (clear or almost clear', ""Psoriasis Area and Severity Index (PASI) and a static Physician's Global Assessment (sPGA"", 'quality of life', 'number of adverse events', 'efficacy and safety', 'frequencies of adverse events', 'severity of psoriasis']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",506.0,0.482329,"The frequencies of adverse events in the risankizumab, ustekinumab and placebo groups were similar in both studies.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Janabi', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'Z K', 'Initials': 'ZK', 'LastName': 'Jabbar-Lopez', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London & Guy's and St Thomas' NHS Foundation Trust, London, U.K.""}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'Z Z N', 'Initials': 'ZZN', 'LastName': 'Yiu', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}]",The British journal of dermatology,['10.1111/bjd.17624']
704,31184796,An open-ended primary-care group intervention for insomnia based on a self-help book - A randomized controlled trial and 4-year follow-up.,"Chronic insomnia is a common and burdensome problem for patients seeking primary care. Cognitive behavioural therapy has been shown to be effective for insomnia, also when presented with co-morbidities, but access to sleep therapists is limited. Group-treatment and self-administered treatment via self-help books have both been shown to be efficacious treatment options, and the present study aimed to evaluate the effect of an open-ended group intervention based on a self-help book for insomnia, adapted to fit a primary-care setting. Forty primary-care patients with insomnia (mean age 55 years, 80% women) were randomized to the open-ended group intervention based on a cognitive behavioural therapy for insomnia self-help book or to a care as usual/wait-list control condition. Results show high attendance to group sessions and high treatment satisfaction. Participants in the control group later received the self-help book, but without the group intervention. The book-based group treatment resulted in significantly improved insomnia severity, as well as shorter sleep-onset latency, less wake time after sleep onset, and less use of sleep medication compared with treatment as usual. The improvements were sustained at a 4-year follow-up assessment. A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book. An open-ended treatment group based on a self-help book for insomnia thus seems to be an effective and feasible intervention for chronic insomnia in primary-care settings.",2020,A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book.,"['patients seeking primary care', 'Forty primary-care patients with insomnia (mean age 55\u2009years, 80% women']","['open-ended primary-care group intervention for insomnia based on a self-help book ', 'Cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia self-help book or to a care as usual/wait-list control condition']","['shorter sleep-onset latency, less wake time after sleep onset, and less use of sleep medication', 'insomnia severity', 'Chronic insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}]",,0.0295454,A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book.,"[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Bothelius', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Blom', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindhe', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Karimi', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Melder', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Bondestam', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ulfsparre', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Sternbrink', 'Affiliation': 'Gustavsbergs Primary Care Centre, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jernelöv', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12881']
705,31892758,The comparative efficacy of disinfectant wipes on common-use computer keyboards in a veterinary teaching hospital.,"The efficacies of 3 disinfectant wipes at reducing bacterial contamination on keyboards in a veterinary teaching hospital were studied. Thirty common-use keyboards were randomized into ""dirty"" and ""clean"" halves. Cultures were obtained from the ""dirty"" halves. The ""clean"" halves were disinfected with a randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured. Colony-forming units (CFU) were enumerated after 48 hours. Mean reduction in CFU was 91.5%, 65.3%, 94.9%, and 78.8% for the AHP, alcohol, QAC, and NT groups, respectively. There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups. The reduction in CFUs in the NT group was attributed to the mechanical action of wiping the keyboard surface for culture. The use of disinfectant wipes reduced CFUs on keyboards and may be a useful component of veterinary infection control programs.",2020,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,['Thirty common-use keyboards'],"['randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured', 'disinfectant wipes']","['Mean reduction in CFU', 'CFUs', 'reduction in CFUs']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",30.0,0.016321,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,"[{'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Wong', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Brandy A', 'Initials': 'BA', 'LastName': 'Burgess', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Ben M', 'Initials': 'BM', 'LastName': 'Brainard', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Greene', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hurley', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Koenig', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}]",The Canadian veterinary journal = La revue veterinaire canadienne,[]
706,31278996,Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up.,"OBJECTIVE


To report on the 32-week outcome of the Brief Behavioral Therapy (BBT) for Pediatric Anxiety and Depression in Primary Care clinical trial.
METHOD


A total of 185 youths aged 8 to 17 years with anxiety and/or depression identified through 9 pediatric primary care (PPC) settings in San Diego and Pittsburgh were randomized to receive Assisted Referral to Care (ARC) or up to 12 sessions of BBT over 16 weeks. The primary outcome was clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score of ≤2. Secondary outcomes included interview-rated functioning, depression, and anxiety. Here, we report on outcomes at 32 weeks after randomization. All analyses with primary outcomes are corrected for multiple comparisons using the false discovery rate procedure.
RESULTS


At 32 weeks, BBT was superior to ARC with respect to response (67.5% versus 43.1%, q = 0.03, number needed to treat [NNT] = 5) and functioning (d = 0.49, q = 0.04). BBT was superior to ARC with respect to its impact on anxiety (f = 0.21) but not depressive symptoms (f = 0.05). These findings persisted after controlling for the number of sessions received. Ethnicity moderated the impact of BBT on outcome (NNT for Hispanic youths = 2), because of a much lower response rate to ARC in Hispanic than in non-Hispanic youths (16.7% versus 49.2%, p = 0.04).
CONCLUSION


BBT is a promising intervention that can be effectively delivered in PPC and may be particularly effective for Hispanic patients. Further work is indicated to improve its impact on depressive symptoms and to test BBT against other treatments delivered in pediatric primary care.
CLINICAL TRIAL REGISTRATION INFORMATION


Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care; http://clinicaltrials.gov; NCT01147614.",2020,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"['PPC) settings in San Diego and Pittsburgh', 'Hispanic patients', 'Pediatric Anxiety and Depression in Primary Care', '185 youth aged 8-17 with anxiety and/or depression identified through 9 pediatric primary care']","['Brief Behavioral Therapy (BBT', 'Brief Behavioral Therapy', 'Assisted Referral to Care (ARC', 'BBT']","['interview-rated functioning, depression, and anxiety', 'False Discovery Rate technique', 'clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score ≤ 2', 'anxiety']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",185.0,0.0469208,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Brent', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, Pennsylvania; University of Pittsburgh School of Medicine, Pennsylvania. Electronic address: brentda@upmc.edu.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Porta', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, Colorado.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'California State University, Long Beach.'}, {'ForeName': 'Karen T G', 'Initials': 'KTG', 'LastName': 'Schwartz', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego.'}, {'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Lynch', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Iyengar', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'V Robin', 'Initials': 'VR', 'LastName': 'Weersing', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.06.009']
707,31899739,"Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized, Controlled Trial.","BACKGROUND


In patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of bone marrow aspirate concentrate (BMAC) could delay the progression of osteonecrosis and improve symptoms in pre-fracture ONFH. However, the BMAC content, especially in osteoblastic stem cells, could have an important individual variability. An autologous osteoblastic cell product could improve the effect of such cell-based therapy.
QUESTIONS/PURPOSES


(1) Does autologous osteoblastic cell therapy decrease the likelihood of progression to subchondral fracture with or without early collapse corresponding to Association Research Circulation Osseous (ARCO) classification Stage III or higher, and provide a clinically important pain improvement compared with BMAC treatment alone? (2) Were patients treated with osteoblastic cell therapy less likely to undergo subsequent THA? (3) What proportion of patients in the treatment and control groups experienced adverse events after surgery?
METHODS


Between 2004 and 2011, we treated 279 patients for Stage I to II hip osteonecrosis (ON) with surgery. During that time, our general indications for surgery in this setting included non-fracture ON lesions. To be eligible for this randomized, single-blind trial, patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV. Of those treated surgically for this diagnosis during the study period, 24% (67) agreed to participate in this randomized trial. Hips with pre-fracture ONFH were randomly treated with a core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell group; n = 30). The groups were not different in terms of clinical and imaging characteristics. The primary study outcome was treatment response, defined as the absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS. The secondary endpoint of interest was the frequency in each group of subsequent THA and the frequency of adverse events. The follow-up duration was 36 months. We used an as-treated analysis (rather than intention-to-treat) for our efficacy endpoint, and an intention-to-treat analysis for adverse events. Overall, 26 of 26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial.
RESULTS


At 36 months, no clinically important differences were found in any study endpoint. There was no difference in the proportion of patients who had progressed to fracture (ARCO stage III or higher; 46% of the BMAC hips [12 of 26] versus 22% in the hips with osteoblastic cells [six of 27], hazard ratio, 0.47 [95% CI 0.17 to 1.31]; p = 0.15). There was no clinically important difference in VAS pain scores. No differences were found for either the WOMAC or the Lequesne indexes. With the numbers available, there was no difference in the proportion of patients in the groups who underwent THA at 36 months 15% (four of 27) with osteoblastic cells versus 35% (nine of 26) with BMAC; p = 0.09 With the numbers available, we found no differences between the treatment and control groups in terms of the frequencies of major adverse events.
CONCLUSIONS


We found no benefit to osteoblastic cells over BMAC in patients with pre-collapse ONFH; side effects were uncommon and generally mild in both groups. This study could be used as pilot data to help determine sample sizes for larger (presumably multicenter) randomized controlled trials. However, this novel treatment cannot be recommended in routine practice until future, larger studies demonstrate efficacy.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,No differences were found for either the WOMAC or the Lequesne indexes.,"['patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV', '26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial', 'Hips with pre-fracture ONFH', 'patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of', 'Between 2004 and 2011', '279 patients for Stage I to II hip osteonecrosis (ON) with surgery']","['autologous osteoblastic cell therapy', 'bone marrow aspirate concentrate (BMAC', 'core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell', 'Osteoblastic Cell Therapy', 'osteoblastic cell therapy']","['absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS', 'subsequent THA and the frequency of adverse events', 'adverse events', 'VAS pain scores']","[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}, {'cui': 'C0857285', 'cui_str': 'Marrow aspirate'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.116832,No differences were found for either the WOMAC or the Lequesne indexes.,"[{'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Hauzeur', 'Affiliation': 'J.-P. Hauzeur, Rheumatology and Physical Medicine Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium C. Lechanteur, Y. Beguin, E. Baudoux, Haematology & Laboratory of Cell Therapy, CHU de Liège, Université de Liège, Liège, Belgium V. De Maertelaer, SBIM & IRIBHM, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium S. Pather, R. Katz, Radiology Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium. M. Malaise, J.-P. Hauzeur, Department of Rheumatology, CHU de Liège, Université de Liège, Liège, Belgium J. Ino, Bone Therapeutics S.A., Gosselies, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Lechanteur', 'Affiliation': ''}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Baudoux', 'Affiliation': ''}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'De Maertelaer', 'Affiliation': ''}, {'ForeName': 'Sanjiva', 'Initials': 'S', 'LastName': 'Pather', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malaise', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ino', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Beguin', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001107']
708,31899803,Promising results from an implemented treatment model for paediatric obesity.,"AIM


To investigate the implementation of a plan of action for treatment of childhood obesity, and the effect after 2 years of treatment.
METHODS


Children aged 6-12.9 years who started obesity treatment between 2008 and 2015 in a paediatric clinic in Stockholm County were included. The treatment model included staff education and support and group activities for parents and children separately followed by individual sessions to a multidisciplinary team. The main outcome was change in body mass index standard deviation score (BMI SDS), in comparison to a matched control group.
RESULTS


In the intervention group, 1334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3012 children in the control group were included. The intervention group decreased their BMI SDS more after two years compared with the control group, (-0.31 vs -0.23, P < .001). Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all P < .001) had greater decreases in BMI SDS after 2 years. Sex did not affect the outcome.
CONCLUSION


Even though the treatment in the control group was effective, the implementation of the action plan yielded a better treatment response compared with the control group.",2020,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"['paediatric obesity', '1,334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3,012 children in the control group were included', 'Children aged 6-12.9 years who started obesity treatment between 2008-2015 in a paediatric clinic in Stockholm County were included']",[],"['BMI SDS', 'body mass index standard deviation score (BMI SDS']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1334.0,0.0355141,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bohlin', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Klaesson', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ejderhamn', 'Affiliation': ""Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15158']
709,31648401,Comparative study of autoimplantation therapy and intralesional injection of MMR vaccine in warts treatment.,"Autoimplantation is a simple technique and considered as a novel method of immunotherapy in treating warts. Intralesional immunotherapy by mumps, measles, and rubella (MMR) vaccine is also a promising treatment modality for multiple warts. To compare the efficacy and safety of both the methods in treating multiple warts, the study included 80 patients divided into two groups (Group A and Group B), each containing 40 patients. Informed consent was taken from each patient before enrollment into the study. Group A patients were treated by autoimplantation technique every 2 weeks for a maximum of four treatments. Similarly, Group B patients received MMR intralesional injection at a dose of 0.5 ml every 2 weeks for a maximum of four treatments. Complete clearance of the donor wart was observed in 60% patients in Group A, whereas complete clearance in the Group B injected by MMR was 72.5%. On the other hand, a significant difference (p < .05) was found in the therapeutic response among nonmanipulated warts in both groups, where complete clearance was observed in 47.5% of Group A patients versus 20% of Group B patients. Autoimplantation is a suitable approach for patients with multiple warts associated with distant lesions, while MMR injection is ideal for a single or fewer number of warts.",2019,"On the other hand, a significant difference (p<0.05) was found in the therapeutic response among non-manipulated warts in both groups, where complete clearance was observed in 47.5% of group A patients versus 20% of group B patients.
","['patients with multiple warts associated with distant lesions', 'warts treatment', '80 patients divided into two groups (group A and group B), each containing 40 patients']","['Autoimplantation therapy and Intralesional injection of MMR vaccine', 'Intralesional immunotherapy by Mumps, Measles, and Rubella (MMR) vaccine', 'MMR intralesional injection']","['complete clearance', 'therapeutic response', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0555965', 'cui_str': 'Wart treatment (regime/therapy)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021490', 'cui_str': 'Injections, Intralesional'}, {'cui': 'C0065828', 'cui_str': 'MMR Vaccine'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.0205024,"On the other hand, a significant difference (p<0.05) was found in the therapeutic response among non-manipulated warts in both groups, where complete clearance was observed in 47.5% of group A patients versus 20% of group B patients.
","[{'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'ElGhareeb', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13135']
710,31562875,Effectiveness of Paraffin and Sustained Stretch in Treatment of Shoulder Contractures Following a Burn Injury.,"OBJECTIVE


To examine if range of motion of the shoulder treated with paraffin will be better than that of the shoulder treated with sustained stretch alone.
DESIGN


Pilot randomized controlled trial.
SETTING


Regional burn center.
PARTICIPANTS


Patients (N=23) who sustained a burn injury, with a shoulder active abduction and/or flexion in the +70° to +150° degree range, who were 14 years or older, were receiving follow-up physical therapy after discharge from hospital, and provided a signed consent to participate.
INTERVENTIONS


Group A received sustained stretch and paraffin, and group B received sustained stretch only. Both groups had 6 sessions of treatment over 2 weeks.
MAIN OUTCOME MEASURES


Active range of motion (AROM) and active-assisted range of motion (AAROM) for shoulder flexion (SF) and shoulder abduction (SA) were measured before and after each treatment session.
RESULTS


For pretreatment measurements, only the results for SF AAROM had significant time effects. For posttreatment measurements, SF AROM and SF AAROM had significant effects for time. Session 1 was significantly lower than sessions 2, 3, 4, and 6 for both measures, and additionally, session 1 was significantly lower than session 5 for SF AAROM. For SA AROM, a group-by-time interaction effect was significant, with scores for the paraffin group relatively stable across sessions, and the nonparaffin group had peaks at sessions 3 and 6. There were no significant effects for (1) within-session changes to examine improvement during a session or (2) presession scores across the 6 sessions showing maintenance of motion. Total change from the first session presession measurement to the sixth session postsession measurement for the 2 treatment groups were nonsignificantly different.
CONCLUSIONS


As shown in this study, sustained stretching with paraffin may be a valuable adjunct to range of motion intervention for the shoulder after burn injury.",2020,"Session 1 was found to be significantly lower than sessions 2, 3, 4, and 6 for both measures and additionally session 1 was significantly lower than session 5 for SF-AAROM.","[' Patients (N=23) who sustained a burn injury, with an shoulder active abduction and/or flexion in the +70°- +150° degree, who were ≥ 14 years of age, receiving follow-up physical therapy after discharge from hospital, and provided a signed consent to participate', 'Shoulder Contractures following a Burn Injury']","['paraffin', 'sustained stretch and paraffin and Group B received sustained stretch only', 'Paraffin and Sustained Stretch']","['Active Range of Motion (AROM) and Active-Assisted Range of Motion (AAROM) for Shoulder Flexion ', 'SF-AROM and SF-AAROM)) and Shoulder Abduction (SA-AROM and SA-AAROM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}]",,0.0436857,"Session 1 was found to be significantly lower than sessions 2, 3, 4, and 6 for both measures and additionally session 1 was significantly lower than session 5 for SF-AAROM.","[{'ForeName': 'Radha K', 'Initials': 'RK', 'LastName': 'Holavanahalli', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: Radha.holavanahalli@utsouthwestern.edu.'}, {'ForeName': 'Phala A', 'Initials': 'PA', 'LastName': 'Helm', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Kowalske', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'Department of Clinical Sciences, Division of Biostatistics, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.08.482']
711,30222437,Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study.,"BACKGROUND


Previous research demonstrated that providing qualitative and quantitative information in a ""drug facts box"" may help individuals understand prescription drug information in print-based direct-to-consumer advertisements. The authors sought to determine whether qualitative, quantitative, or a combination thereof best communicates benefit and risk information.
METHODS


To replicate and extend previous research, the authors used simple quantitative drug information. A randomized controlled study was conducted with 5067 Internet panelists with heartburn. Participants viewed a drug facts box with benefit and risk information that varied the presence or absence of qualitative summaries and absolute frequencies, percentages, and absolute differences. Measures included knowledge of drug benefits and risks, perceptions, and intentions.
RESULTS


Providing absolute frequencies and percentages most improved participants' drug knowledge and affected perceptions and intentions.
CONCLUSIONS


The study findings suggest that, for simple drug information, adding absolute frequencies and percentages to direct-to-consumer advertisements may benefit consumers. Absolute differences and qualitative labels may not be needed.",2015,"BACKGROUND


Previous research demonstrated that providing qualitative and quantitative information in a ""drug facts box"" may help individuals understand prescription drug information in print-based direct-to-consumer advertisements.","['5067 Internet panelists with heartburn', 'Direct-to-Consumer Print Advertisements']",[],"['knowledge of drug benefits and risks, perceptions, and intentions']","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0456991,"BACKGROUND


Previous research demonstrated that providing qualitative and quantitative information in a ""drug facts box"" may help individuals understand prescription drug information in print-based direct-to-consumer advertisements.","[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': '1 US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': '1 US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': '1 US Food and Drug Administration, Silver Spring, MD, USA.'}]",Therapeutic innovation & regulatory science,['10.1177/2168479015572370']
712,31834936,Effect of a smartphone intervention on self-managed medication abortion experiences among safe-abortion hotline clients in Indonesia: A randomized controlled trial.,"OBJECTIVE


To investigate the impact of a smartphone application (app) providing information and support for medication abortion (MA) on the primary outcomes of 'feelings of support' and 'preparedness' among clients of Samsara, a safe-abortion hotline in Indonesia.
METHODS


In a parallel-arm, non-clinical, randomized controlled trial, women (ages ≥15) who contacted Samsara between February 2017- July 2018 seeking information on MA for pregnancies ≤13 weeks gestation were randomized to receive either an app with abortion information, or standard of care (high-quality comprehensive and empathic counseling on pregnancy options). Participants completed a questionnaire 24 days after enrollment; Fisher exact tests and risk differences were used to assess differences in self-reported feelings of preparedness and support throughout the process of self-managed MA.
RESULTS


No differences in feelings of support or preparedness were detected between participants in the app arm versus the standard of care arm.
CONCLUSION


This study represents the first-ever randomized control trial (and prospective study) among those who contacted a safe-abortion hotline for information about and support for self-managed abortion. Levels of preparedness, confidence, and feelings of support were all extremely high among both control and intervention arms-indicative of the high-quality, evidence-based information, comprehensive, and supportive abortion counseling that safe-abortion hotline clients receive.",2020,"No differences in feelings of support or preparedness were detected between participants in the app arm versus the standard of care arm.
","['those who contacted a safe-abortion hotline for information about and support for self-managed abortion', ""feelings of support' and 'preparedness' among clients of Samsara, a safe-abortion hotline in Indonesia"", 'women (ages ≥15) who contacted Samsara between February 2017- July 2018 seeking information on MA for pregnancies ≤13\xa0weeks gestation', 'self-managed medication abortion experiences among safe-abortion hotline clients in Indonesia']","['smartphone intervention', 'app with abortion information, or standard of care (high-quality comprehensive and empathic counseling on pregnancy options', 'smartphone application (app) providing information and support for medication abortion (MA']","['Levels of preparedness, confidence, and feelings of support', 'feelings of support or preparedness']","[{'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0518532', 'cui_str': 'Does manage medication (finding)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.110659,"No differences in feelings of support or preparedness were detected between participants in the app arm versus the standard of care arm.
","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gerdts', 'Affiliation': 'Ibis Reproductive Health, Oakland, CA, USA.'}, {'ForeName': 'Ruvani T', 'Initials': 'RT', 'LastName': 'Jayaweera', 'Affiliation': 'Ibis Reproductive Health, Oakland, CA, USA.'}, {'ForeName': 'Ika A', 'Initials': 'IA', 'LastName': 'Kristianingrum', 'Affiliation': 'Samsara Hotline, Indonesia.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Ibis Reproductive Health, Oakland, CA, USA.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Hudaya', 'Affiliation': 'Samsara Hotline, Indonesia.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13086']
713,31621181,Effects of a Symptom Management Program for Patients With Type 2 Diabetes: Implications for Evidence-Based Practice.,"BACKGROUND


Findings from previous studies examining the effectiveness of symptom management on patients with diabetes that were implemented in home settings were inconclusive. Exploring the effects of a diabetes symptom management program on patients with type 2 diabetes mellitus (T2DM) in clinical settings is useful for healthcare providers to improve their diabetes care.
AIMS


To examine the effects of a diabetes symptom management program (DSMP) on HbA1c levels, self-care behaviors, quality of life (QoL), and symptom severity in clinics in patients with T2DM.
METHODS


This study was a single-blind randomized controlled trial. The control group (n = 30) received usual care. The experimental group (n = 30) received DSMP and usual care. The primary outcome variable was HbA1c levels; the secondary outcome variables were self-care behaviors, QoL, and diabetes symptom severity. Outcome variables were measured at baseline (T0), 3 months (T1) and 6 months after the intervention (T2), and HbA1c levels were further collected at 9 months after the intervention (T3).
RESULTS


The decreasing levels of HbA1c from T0 to T2 and from T0 to T3 and for severity of diabetes symptoms from T0 to T2 in the experimental group were significantly better than those in the control group. The increasing levels of self-care behavior and QoL from T0 to T1 and from T0 to T2 in the experimental group were significantly higher than those in the control group.
LINKING EVIDENCE TO ACTION


DSMP implemented in the clinic setting has effects on improving HbA1c, self-care behaviors, QoL, and preventing worsening severity of diabetes symptoms for outpatients with T2DM. Healthcare providers could assess diabetes symptoms of patients with high HbA1c levels and provide symptom management care rather than merely providing education on improvement of self-care behaviors.",2019,"The increasing levels of self-care behavior and QoL from T0 to T1 and from T0 to T2 in the experimental group were significantly higher than those in the control group.
","['outpatients with T2DM', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'patients with diabetes', 'clinics in patients with T2DM']","['diabetes symptom management program (DSMP', 'diabetes symptom management program', 'DSMP and usual care', 'Symptom Management Program', 'usual care']","['self-care behaviors, QoL, and diabetes symptom severity', 'HbA1c levels', 'severity of diabetes symptoms', 'HbA1c levels, self-care behaviors, quality of life (QoL), and symptom severity', 'levels of HbA1c', 'levels of self-care behavior and QoL']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0259238,"The increasing levels of self-care behavior and QoL from T0 to T1 and from T0 to T2 in the experimental group were significantly higher than those in the control group.
","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.'}, {'ForeName': 'Bih-O', 'Initials': 'BO', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ruey-Hsia', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12400']
714,30207587,"Granulocyte-macrophage colony-stimulating factor (GM-CSF) as a therapeutic target in psoriasis: randomized, controlled investigation using namilumab, a specific human anti-GM-CSF monoclonal antibody.","BACKGROUND


The relevance of granulocyte-macrophage colony-stimulating factor (GM-CSF) in the management of psoriasis has not been studied previously. GM-CSF is important in the initiation and maintenance of chronic inflammatory processes.
OBJECTIVES


To investigate the clinical use of GM-CSF neutralization by evaluating the efficacy and safety of namilumab (AMG203), a monoclonal antibody GM-CSF inhibitor, in patients with moderate-to-severe plaque psoriasis.
METHODS


A phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group, dose-finding, proof-of-concept study (NEPTUNE) was conducted. Four doses of namilumab (20, 50, 80 and 150 mg, via subcutaneous injection) were compared with placebo. Assessment of the primary end point - the proportion of patients achieving ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75 treatment response) - was performed at week 12. Exploratory investigation at the tissue level was conducted in a subset of the overall study population. The trial was registered with the number NCT02129777.
RESULTS


In total, 122 patients were enrolled and 106 (86·9%) completed the double-blind treatment; 16 (13·1%) prematurely discontinued study medication. Serum concentration-time profiles were as expected for subcutaneous delivery of an IgG1 monoclonal antibody, and exposure increased proportionally with dose elevation. The number of patients showing PASI 75 treatment response at week 12 was low in all groups; no significant difference was recorded in this end point between placebo and any namilumab group. Similar outcomes were recorded for other clinical study end points. Moreover, no significant treatment-related changes from baseline were observed in laboratory investigations of cell types or subpopulations, or cytokines relevant to inflammatory pathways in psoriasis.
CONCLUSIONS


GM-CSF blockade is not critical for suppression of key inflammatory pathways underlying psoriasis.",2019,The number of patients showing PASI 75 treatment response at week 12 was low in all groups; no significant difference was recorded in this end point between placebo and any namilumab group.,"['122 patients were enrolled and 106 (86·9%) completed the double-blind treatment', 'patients with moderate-to-severe plaque psoriasis', 'psoriasis']","['placebo', 'Granulocyte-macrophage colony-stimulating factor (GM-CSF', 'monoclonal antibody GM-CSF inhibitor', 'granulocyte-macrophage colony-stimulating factor (GM-CSF', 'namilumab (AMG203', 'namilumab']","['number of patients showing PASI 75 treatment response', 'Serum concentration-time profiles', 'Psoriasis Area and Severity Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3273714', 'cui_str': 'namilumab'}, {'cui': 'C4548249', 'cui_str': 'AMG203'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",122.0,0.203441,The number of patients showing PASI 75 treatment response at week 12 was low in all groups; no significant difference was recorded in this end point between placebo and any namilumab group.,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, 135 Union St E, Waterloo, ON, N2J1C4, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, ON, Canada.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jenkins', 'Affiliation': 'Clinical Science, Takeda International - U.K. Branch, London, U.K.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vender', 'Affiliation': 'Dermatrials Research Inc, Hamilton, ON, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Modelling and Simulation, Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': 'Statistics, Takeda International, Deerfield, IL, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Souberbielle', 'Affiliation': 'Clinical Science, Takeda International - U.K. Branch, London, U.K.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.17195']
715,31762179,Integration of Different Sensory Interventions From Mother's Breast Milk for Preterm Infant Pain During Peripheral Venipuncture Procedures: A Prospective Randomized Controlled Trial.,"PURPOSE


To compare the effects of integrating mother's breast milk (BM) with three different combinations of sensory stimuli on preterm infant pain during peripheral venipuncture procedures.
DESIGN


A prospective, repeated-measures randomized controlled trial.
METHODS


Preterm infants (gestational age between 28 and 37 weeks, and in stable condition) needing venipuncture were recruited by convenience sampling (N = 140) and randomly assigned to four treatment conditions: (a) routine care (condition 1); (b) BM odor or taste (condition 2); (c) BM odor or taste + heartbeat sounds (HBs; condition 3), and (d) BM odor or taste + HBs + non-nutritive sucking (NNS; condition 4). Pain scores were assessed based on the Premature Infant Pain Profile-Revised (PIPP-R) over nine phases: baseline (phase 0, 5 min without stimuli before venipuncture), disinfecting (phase 1), during venipuncture (phase 2), and a 10-min recovery (phases 3-8).
FINDINGS


Infants who received BM odor or taste + HBs + NNS had significantly lower increases in pain scores from baseline compared with controls across phases 1 through 8. Infants treated with either condition 2 or 3 demonstrated significant reductions in mild pain during disinfecting and recovery phases, as compared with the controls. When condition 2 was used as the reference, there were no significant differences in pain scores between the infants receiving condition 3 across the nine phases, suggesting mothers' HBs have only mild analgesic effects on venipuncture pain.
CONCLUSIONS


Integration of mother's BM odor or taste, HBs, and tactile NNS should be considered as an intervention for alleviation of procedural pain for preterm infants.
CLINICAL RELEVANCE


Clinicians should incorporate the integrated sensory intervention into caregiving support for preterm infants undergoing short painful procedures.",2020,"When condition 2 was used as the reference, there were no significant differences in pain scores between the infants receiving condition 3 across the nine phases, suggesting mothers' HBs have only mild analgesic effects on venipuncture pain.
","['preterm infant pain during peripheral venipuncture procedures', 'Preterm infants (gestational age between 28 and 37 weeks, and in stable condition) needing venipuncture were recruited by convenience sampling (N = 140', 'preterm infants', 'preterm infants undergoing short painful procedures']","['Sensory Interventions', 'routine care (condition 1); (b) BM odor or taste (condition 2); (c) BM odor or taste + heartbeat sounds (HBs; condition 3), and (d) BM odor or taste + HBs + non-nutritive sucking (NNS; condition 4', ""integrating mother's breast milk (BM) with three different combinations of sensory stimuli""]","['pain scores', 'Preterm Infant Pain', 'Pain scores', 'Premature Infant Pain Profile-Revised (PIPP-R', 'mild pain']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0019043', 'cui_str': 'Hemoglobin S'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking (regime/therapy)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}]",,0.212376,"When condition 2 was used as the reference, there were no significant differences in pain scores between the infants receiving condition 3 across the nine phases, suggesting mothers' HBs have only mild analgesic effects on venipuncture pain.
","[{'ForeName': 'Hsiang-Ping', 'Initials': 'HP', 'LastName': 'Wu', 'Affiliation': 'Lambda Beta-At-Large, Doctoral Student, Graduate Institute of Medical Sciences, National Defense Medical Center, Taipei City, Taiwan, R.O.C. and Lecturer, Department of Nursing, Chung-Jen Junior College of Nursing, Health Sciences and Management, Chia-Yi City, Taiwan, R.O.C.'}, {'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Yin', 'Affiliation': 'Lambda Beta-At-Large, Assistant Professor, Nursing Department, Song-Shan Branch, Tri-Service General Hospital, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Kao-Hsian', 'Initials': 'KH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pediatrics, Tri-Service General Hospital, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Hsiang-Yun', 'Initials': 'HY', 'LastName': 'Lan', 'Affiliation': 'Lambda Beta-At-Large, Assistant Professor, School of Nursing, National Defense Medical Center, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Rung-Chuang', 'Initials': 'RC', 'LastName': 'Feng', 'Affiliation': 'Assistant Professor, National Defense Medical Center & Department of Nursing, Taipei City Hospital, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Yue-Cune', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Professor, Department of Mathematics, Tamkang University, Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Jen-Jiuan', 'Initials': 'JJ', 'LastName': 'Liaw', 'Affiliation': 'Lambda Beta-At-Large, Professor, School of Nursing, National Defense Medical Center, Taipei City, Taiwan, R.O.C.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12530']
716,31842026,The effects of doxapram on time to tracheal extubation and early recovery in young morbidly obese patients scheduled for bariatric surgery: A randomised controlled trial.,"BACKGROUND


Bariatric surgery is a well established treatment of the obese. Postoperative respiratory failure and airway obstruction after bariatric surgery can often be attributed to the residual depressant effects of anaesthetics, sedatives and opioids. Peri-operative management of morbidly obese patients is still a concern for operating room professionals.
OBJECTIVE


The evaluation of the effects of doxapram on the outcomes of general anaesthesia following bariatric surgical procedures in the morbidly obese.
DESIGN


A single-blind randomised controlled trial with two parallel arms.
SETTING


A tertiary care teaching hospital, Tehran, Iran, from 2017 to 2018.
PARTICIPANTS


In total, 100 patients (69 women) with at least class two obesity were included in two groups of equal sizes and underwent bariatric surgery.
MAIN OUTCOME MEASURES


The primary outcome was the time from the administration of doxapram to tracheal extubation. Secondary outcomes included vital signs and variables including peak expiratory flow rate, time to return to spontaneous breathing, time to eye-opening and hand-squeezing on the commands, and time to recovery.
INTERVENTIONS


Both groups underwent general anaesthesia. The intervention group received a single dose of doxapram 1 mg kg ideal body weight, immediately after reversal of neuromuscular blockade and after discontinuation of all anaesthetics.
RESULTS


Doxapram decreased time to extubation, time to eye-opening and hand-squeezing, shortened recovery time and lowered end-tidal CO2 significantly (all P < 0.001). Moreover, it increased peak expiratory flow rate, oxygen saturation, temperature, heart rate and blood pressure (all P < 0.001). The two groups were similar in the bispectral index and mean arterial pressure (both P > 0.05). None of our participants had complications attributable to doxapram.
CONCLUSION


The postoperative use of doxapram improves peak expiratory flow rate, and decreases respiratory complications of anaesthesia during recovery in the morbidly obese undergoing bariatric surgery. Doxapram is well tolerated in young ASA physical status classes 1 to 2 morbidly obese patients; however, the anaesthesiologist should cautiously evaluate the vital signs for at least half an hour following the administration of doxapram.
REGISTRATION


Iranian Registry of Clinical Trials (IRCT) http://www.irct.ir/ number IRCT2017060712203N9.",2020,"RESULTS


Doxapram decreased time to extubation, time to eye-opening and hand-squeezing, shortened recovery time and lowered end-tidal CO2 significantly (all P < 0.001).","['morbidly obese', 'young ASA physical status classes 1 to 2 morbidly obese patients', 'morbidly obese undergoing bariatric surgery', 'A tertiary care teaching hospital, Tehran, Iran, from 2017 to 2018', 'morbidly obese patients', 'young morbidly obese patients scheduled for bariatric surgery', '100 patients (69 women) with at least class two obesity were included in two groups of equal sizes and underwent bariatric surgery']","['general anaesthesia', 'doxapram', 'Doxapram', 'doxapram 1\u200amg\u200akg ideal body weight']","['Postoperative respiratory failure and airway obstruction', 'vital signs and variables including peak expiratory flow rate, time to return to spontaneous breathing, time to eye-opening and hand-squeezing on the commands, and time to recovery', 'bispectral index and mean arterial pressure', 'peak expiratory flow rate', 'peak expiratory flow rate, oxygen saturation, temperature, heart rate and blood pressure', 'time from the administration of doxapram to tracheal extubation', 'time to extubation, time to eye-opening and hand-squeezing, shortened recovery time and lowered end-tidal CO2']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1531504', 'cui_str': 'ASA physical status class 1'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0013084', 'cui_str': 'Doxapram'}, {'cui': 'C0421272', 'cui_str': 'Normal Body Weight'}]","[{'cui': 'C3495821', 'cui_str': 'Postoperative respiratory failure'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0518766'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013084', 'cui_str': 'Doxapram'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}]",69.0,0.229746,"RESULTS


Doxapram decreased time to extubation, time to eye-opening and hand-squeezing, shortened recovery time and lowered end-tidal CO2 significantly (all P < 0.001).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'From the Department of Anaesthesiology, Faculty of Medicine, Critical Care Quality Improvement Research Centre at Shahid Modarres Hospital (MF, NN), Department of Anaesthesiology, Faculty of Medicine, Clinical Research and Development Unit at Shahid Modarres Hospital (NM) and Faculty of Medicine, Anaesthesiology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran (RBM).'}, {'ForeName': 'Nilofar', 'Initials': 'N', 'LastName': 'Massoudi', 'Affiliation': ''}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Nooraee', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Beheshti Monfared', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001144']
717,31884945,Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial.,"BACKGROUND


Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home.
METHODS


This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state.
DISCUSSION


The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.",2019,Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF.,"['advanced heart failure patients and their family caregivers in rural appalachia', 'Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers', 'patients and family members managing home supportive EOLPC for advanced HF']","['intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions', 'coaching end-of-life palliative care', 'routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses', 'FamPALcare nursing care intervention', 'FamPALcare intervention']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]",[],,0.100585,Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF.,"[{'ForeName': 'Ubolrat', 'Initials': 'U', 'LastName': 'Piamjariyakul', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA. ubolrat.piamjariyakul@hsc.wvu.edu.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Petitte', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Smothers', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics School of Public Health, West Virginia University, Morgantown, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sokos', 'Affiliation': 'Advanced Heart Failure, West Virginia University Heart and Vascular Institute, J.W. Ruby Memorial Hospital, Morgantown, USA.'}, {'ForeName': 'Alvin H', 'Initials': 'AH', 'LastName': 'Moss', 'Affiliation': 'Sections of Nephrology and Supportive Care, West Virginia University Center for Health Ethics and Law, Morgantown, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Smith', 'Affiliation': 'University of Kansas Medical Center, School of Nursing and School of Preventive Medicine, Morgantown, USA.'}]",BMC palliative care,['10.1186/s12904-019-0500-z']
718,31527167,Biomarker Analyses of Response to Cyclin-Dependent Kinase 4/6 Inhibition and Endocrine Therapy in Women with Treatment-Naïve Metastatic Breast Cancer.,"PURPOSE


Preclinical data identified the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib as synergistic with antiestrogens in inhibiting growth of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) human breast cancer models. This observation was validated clinically in the randomized, placebo-controlled, phase III PALOMA-2 study.
EXPERIMENTAL DESIGN


To determine markers of sensitivity and resistance to palbociclib plus letrozole, we performed comprehensive biomarker analyses, investigating the correlation with progression-free survival (PFS), on baseline tumor tissues from PALOMA-2.
RESULTS


Despite a broad biomarker search, palbociclib plus letrozole demonstrated consistent PFS gains versus placebo plus letrozole, with no single biomarker or cassette of markers associated with lack of benefit from combination treatment. Palbociclib plus letrozole confers efficacy on both luminal A and B patients. Higher  CDK4  levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, whereas lower PD-1 levels were associated with greater palbociclib plus letrozole benefit. Tumors with more active growth factor signaling, as exemplified by increased expression of  FGFR2  and  ERBB3  mRNA, appeared to be associated with greater PFS gain from the addition of palbociclib.
CONCLUSIONS


These data underscore the importance of CDK4/6 signaling in HR+/HER2- breast cancer and suggest that the interplay between steroid hormone and peptide growth factor signaling could drive dependence on CDK4/6 signaling. See related commentary by Anurag et al., p. 3 .",2020,"Higher CDK4 levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, while lower PD1 levels were associated with greater palbociclib plus letrozole benefit.",['Women'],"['letrozole', 'palbociclib plus letrozole', 'placebo', 'placebo plus letrozole', 'Palbociclib plus letrozole']","['PD1 levels', 'Higher CDK4 levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0617671,"Higher CDK4 levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, while lower PD1 levels were associated with greater palbociclib plus letrozole benefit.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, California. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, Global Product Development Oncology, La Jolla, California.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc, Oncology Translational Research/Computational Biology, La Jolla, California.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Breast Oncology, Institut Curie, and Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of OB&GYN, Brustzentrum der Universität München (LMU), München, Germany.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, Clinical Statistics, La Jolla, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, Department of Clinical Research, San Francisco, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer Inc, Global Medical Affairs, Collegeville, Pennsylvania.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0751']
719,31525829,The efficacy of intermittent pneumatic compression as a substitute for manual lymphatic drainage in complete decongestive therapy in the treatment of breast cancer related lymphedema.,"The aim of this study is to evaluate the efficacy of intermittent pneumatic compression (IPC) as a substitute for manual lymphatic drainage (MLD) in complete decongestive therapy (CDT) for treatment of advanced stages of breast cancer-related lymphedema. In this randomized, single-blind, controlled study, 46 patients with breast cancer-related lymphedema were divided into 2 groups. Both MLD with compression bandage (CB) group (n=24) and IPC with CB group (n=22) received treatment 3 days a week for 5 weeks. Home exercise program was also given to all patients. At the end of the 5th week, patients were treated with a daily 23-hour compression garment and home exercise routines. Assessments were taken at baseline, the fifth week, and the third month. Arm circumference was measured at 5 different areas, shoulder range of motion (ROM) was evaluated with a goniometer, pain, and tightness, and heaviness sensations were assessed with visual analog scale. Both groups had similar demographic and clinical characteristics (p<0.05). There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month. Similarly, shoulder ROM, pain, tightness, and heaviness sensations improved in both groups (p<0.05). Both MLD and IPC as a component of CDT were found successful at 5 weeks and 3 months without superiority to each other.",2019,There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month.,"['breast cancer related lymphedema', '46 patients with breast cancer-related lymphedema', 'advanced stages of breast cancer-related lymphedema']","['intermittent pneumatic compression (IPC', 'intermittent pneumatic compression', 'Home exercise program', 'MLD with compression bandage (CB', 'decongestive therapy (CDT', 'daily 23-hour compression garment and home exercise routines']","['goniometer, pain, and tightness, and heaviness sensations', 'shoulder ROM, pain, tightness, and heaviness sensations']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic Leukoencephalopathy'}, {'cui': 'C0677875', 'cui_str': 'Compression Wraps'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0581912', 'cui_str': 'Heaviness sensation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",46.0,0.0196682,There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanal-Toprak', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ozsoy-Unubol', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}]",Lymphology,[]
720,31890655,Effect of mobile learning (application) on self-care behaviors and blood glucose of type 2 diabetic patients.,"Purpose


More than 70% of the health expenditure is related to chronic diseases. Therefore, an efficient managerial program can markedly reduce medical and administrative costs and benefit both patients and service providers. The use of mobile technologies can be very helpful in this regard. This study was conducted to determine the effect of mobile learning (application) on self-care behaviors and blood glucose control of type 2 diabetic patients attending the Diabetes Clinic of Imam Khomeini Hospital Complex.
Methods


This interventional, quasi-experimental study was conducted on 51 diabetic patients. The patients were randomly assigned to case and control groups, and a specifically designed application was used in the case group for three months. Self-care behavior, FBS, and HbA 1 C were assessed in both groups before and three months after the intervention, and the results were analyzed after the intervention. The Summary of Diabetes Self-Care Activities (SDSCA) measure and medical records was used for data collection. Descriptive and inferential statics (paired t test, ANCOVA analysis) were used for data analysis.
Results


The Mean ± SD of the self-care posttest score, FBS, and HbA 1 C was 76.95 ± 7.94 vs. 43.4 ± 9.74 ( P  = 0.001), 143.58 ± 23.39 vs. 171.81 ± 36.98 (P = 0.001), and 6.84 ± 0.63 vs. 8.10 ± 0.10 (P = 0,001), in the case and control group respectively, indicating a difference in all cases.
Conclusions


The results indicated the positive effect of the mobile application on self-care behavior, FBS, and HbA 1 C.",2019,"Self-care behavior, FBS, and HbA 1 C were assessed in both groups before and three months after the intervention, and the results were analyzed after the intervention.","['51 diabetic patients', 'type 2 diabetic patients', 'type 2 diabetic patients attending the Diabetes Clinic of Imam Khomeini Hospital Complex']",['mobile learning (application'],"['Mean\u2009±\u2009SD of the self-care posttest score, FBS, and HbA 1 C', 'Diabetes Self-Care Activities (SDSCA', 'Self-care behavior, FBS, and HbA 1 C', 'self-care behaviors and blood glucose', 'self-care behavior, FBS, and HbA 1 C']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",51.0,0.024119,"Self-care behavior, FBS, and HbA 1 C were assessed in both groups before and three months after the intervention, and the results were analyzed after the intervention.","[{'ForeName': 'Manizhe', 'Initials': 'M', 'LastName': 'Hooshmandja', 'Affiliation': '1Virtual University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Aeen', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': '2Department of E-Learning in Medical Education, Virtual School, Tehran University of Medical Sciences, Dolatshahi, Naderi St, Keshavarz Blvd, Tehran, 14166-14741 Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Esteghamti', 'Affiliation': '3Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Aliabadi', 'Affiliation': ""4Department of Instructional Technology, Faculty of Psychology and Educational Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Nili', 'Affiliation': ""4Department of Instructional Technology, Faculty of Psychology and Educational Sciences, Allameh Tabataba'i University, Tehran, Iran.""}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00414-1']
721,31694861,Efficacy and Safety of the Glucagon Receptor Antagonist RVT-1502 in Type 2 Diabetes Uncontrolled on Metformin Monotherapy: A 12-Week Dose-Ranging Study.,"OBJECTIVE


Evaluate the safety and efficacy of RVT-1502, a novel oral glucagon receptor antagonist, in subjects with type 2 diabetes inadequately controlled on metformin.
RESEARCH DESIGN AND METHODS


In a phase 2, double-blind, randomized, placebo-controlled study, subjects with type 2 diabetes ( n  = 166) on a stable dose of metformin were randomized (1:1:1:1) to placebo or RVT-1502 5, 10, or 15 mg once daily for 12 weeks. The primary end point was change from baseline in HbA 1c  for each dose of RVT-1502 compared with placebo. Secondary end points included change from baseline in fasting plasma glucose (FPG) and safety assessments.
RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001). The proportions of subjects achieving an HbA 1c  <7.0% were 19.5%, 39.5%, 39.5%, and 45.0% with placebo and RVT-1502 5, 10, and 15 mg ( P  ≤ 0.02 vs. placebo). The frequency of hypoglycemia was low, and no episodes were severe. Mild increases in mean aminotransferase levels remaining below the upper limit of normal were observed with RVT-1502 but were reversible and did not appear to be dose related, with no other liver parameter changes. Weight and lipid changes were similar between RVT-1502 and placebo. RVT-1502-associated mild increases in blood pressure were not dose related or consistent across time.
CONCLUSIONS


Glucagon receptor antagonism with RVT-1502 significantly lowers HbA 1c  and FPG, with a safety profile that supports further clinical development with longer-duration studies (NCT02851849).",2020,"RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001).","['subjects with type 2 diabetes inadequately controlled on metformin', 'subjects with type 2 diabetes ( n  = 166) on a stable dose of']","['RVT-1502 and placebo', 'placebo or RVT-1502', 'metformin', 'RVT-1502', 'placebo', 'Glucagon Receptor Antagonist RVT-1502']","['Weight and lipid changes', 'blood pressure', 'FPG', 'fasting plasma glucose (FPG) and safety assessments', 'Efficacy and Safety', 'frequency of hypoglycemia', 'mean aminotransferase levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.206254,"RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001).","[{'ForeName': 'Jeremy H', 'Initials': 'JH', 'LastName': 'Pettus', 'Affiliation': 'University of California San Diego, San Diego, CA jpettus@ucsd.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Alessio"", 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Vajda', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Pipkin', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Williamson', 'Affiliation': 'Medpace, Cincinnati, OH.'}, {'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Zangmeister', 'Affiliation': 'Medpace, Cincinnati, OH.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhi', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'Keith B', 'Initials': 'KB', 'LastName': 'Marschke', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}]",Diabetes care,['10.2337/dc19-1328']
722,31891790,Standardising communication to improve in-hospital cardiopulmonary resuscitation.,"AIM


Recommendations for standardised communication to reduce chest compression (CC) pauses are lacking. We aimed to achieve consensus and evaluate feasibility and efficacy using standardised communication during cardiopulmonary resuscitation (CPR) events.
METHODS


Modified Delphi consensus process to design standardised communication elements. Feasibility was pilot tested in 16 simulated CPR scenarios (8 scenarios with physician team leaders and 8 with chest compressors) randomized (1:1) to standardised [INTERVENTION] vs. closed-loop communication [CONTROL]. Adherence and efficacy (duration of CC pauses for defibrillation, intubation, rhythm check) was assessed by audiovisual recording. Mental demand and frustration were assessed by NASA task load index subscales.
RESULTS


Consensus elements for standardised communication included: 1) team preparation 15-30 s before CC interruption, 2) pre-interruption countdown synchronized with last 5 CCs, 3) specific action words for defibrillation, intubation, and interrupting/resuming CCs. Median (Q1,Q3) adherence to standardised phrases was 98% (80%,100%). Efficacy analysis showed a median [Q1,Q3] peri-shock pause of 5.1 s. [4.4; 5.8] vs. 7.5 s. [6.3; 8.8] seconds, p < 0.001, intubation pause of 3.8 s. [3.6; 5.0] vs. 6.9 s. [4.8; 10.1] seconds, p = 0.03, rhythm check pause of 4.2 [3.2,5.7] vs. 8.6 [5.0,10.5] seconds, p < 0.001, median frustration index of 10/100 [5,20] vs. 35/100 [25,50], p < 0.001, and median mental demand load of 55/100 [30,70] vs. 65/100 [50,85], p = 0.41 for standardised vs. closed loop communication.
CONCLUSION


This pilot study demonstrated feasibility of using consensus-based standardised communication that was associated with shorter CC pauses for defibrillation, intubation, and rhythm checks without increasing frustration index or mental demand compared to current best practice, closed loop communication.",2020,"This pilot study demonstrated feasibility of using consensus-based standardised communication that was associated with shorter CC pauses for defibrillation, intubation, and rhythm checks without increasing frustration index or mental demand compared to current best practice, closed loop communication.",['16 simulated CPR scenarios (8 scenarios with physician team leaders and 8 with chest compressors'],[],"['Mental demand and frustration', 'median [Q1,Q3] peri-shock pause', 'Adherence and efficacy (duration of CC pauses for defibrillation, intubation, rhythm check', 'median frustration index', 'Median (Q1,Q3) adherence to standardised phrases', 'NASA task load index subscales']","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0817096', 'cui_str': 'Chest'}]",[],"[{'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}, {'cui': 'C0242776', 'cui_str': 'NASA'}]",,0.0678658,"This pilot study demonstrated feasibility of using consensus-based standardised communication that was associated with shorter CC pauses for defibrillation, intubation, and rhythm checks without increasing frustration index or mental demand compared to current best practice, closed loop communication.","[{'ForeName': 'Kasper Glerup', 'Initials': 'KG', 'LastName': 'Lauridsen', 'Affiliation': ""Research Center for Emergency Medicine, Aarhus University Hospital, Denmark; Department of Internal Medicine, Randers Regional Hospital, Denmark; Center for Simulation, Advanced Education and Innovation, Children's Hospital of Philadelphia, USA; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, USA. Electronic address: lauridsekg@email.chop.edu.""}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Watanabe', 'Affiliation': ""Center for Simulation, Advanced Education and Innovation, Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Løfgren', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Denmark; Department of Internal Medicine, Randers Regional Hospital, Denmark; Department of Cardiology, Aarhus University Hospital, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Duval-Arnould', 'Affiliation': 'Simulation Center, Johns Hopkins Medicine, Johns Hopkins University Hospital, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hunt', 'Affiliation': 'Simulation Center, Johns Hopkins Medicine, Johns Hopkins University Hospital, USA; Division of Health Informatics, Johns Hopkins University Hospital, Johns Hopkins Pediatric Hospital, USA; Department of Pediatrics, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Good', 'Affiliation': ""Center for Simulation, Advanced Education and Innovation, Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Niles', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishisaki', 'Affiliation': ""Center for Simulation, Advanced Education and Innovation, Children's Hospital of Philadelphia, USA; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Center for Simulation, Advanced Education and Innovation, Children's Hospital of Philadelphia, USA; Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, USA.""}]",Resuscitation,['10.1016/j.resuscitation.2019.12.013']
723,30978536,Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infection in More than 90% of Patients.,"BACKGROUND & AIMS


Due to the poor eradication rates of standard triple therapy, the addition of bismuth salts has been proposed for first-line eradication of Helicobacter pylori. We assessed the effectiveness and safety of the combination of bismuth and the standard, clarithromycin-containing triple therapy in eradication of H pylori infection, using data from a large multi-center registry.
METHODS


We performed an interim analysis of data from the European Registry on H pylori Management, a prospective trial registering clinical data and outcomes from infected patients from 27 countries in Europe since 2013. We extracted data on 1141 treatment-naïve patients who received first-line treatment with bismuth salts (240 mg) and a proton pump inhibitor (57% received esomeprazole, 18% received omeprazole, 11% received pantoprazole, and 14% received rabeprazole), amoxicillin (1 g), and clarithromycin (500 mg), all taken twice daily.
RESULTS


Intention to treat and per-protocol rates of eradication were 88% and 94%, respectively. Intention to treat eradication increased to 93% in patients who received 14-day treatments. Adverse events occurred in 36% of patients; 76% of these events were mild, with a mean duration of 6 days. In multivariate analysis, eradication was associated with treatment compliance (odds ratio [OR], 13.0), a double dose (equivalent to 40 mg omeprazole) of proton pump inhibitor (OR, 4.7), and 14-day duration of treatment (OR, 2.0).
CONCLUSIONS


In an analysis of data from a large multi-center registry, we found the addition of bismuth to 14-day standard triple therapy with clarithromycin and amoxicillin to eradicate H pylori infection in more than 90% of patients, based on intention to treat analysis, with an acceptable safety profile and level of adherence. ClinicalTrials.gov no: NCT02328131.",2020,"In multivariate analysis, eradication was associated with treatment compliance (odds ratio [OR], 13.0), a double dose (equivalent to 40 mg omeprazole) of proton pump inhibitor (OR, 4.7), and 14-day duration of treatment (OR, 2.0).
","['More than 90% of Patients', '1141 treatment-naïve patients who received first-line treatment with', 'infected patients from 27 countries in Europe since 2013']","['esomeprazole', 'pantoprazole, and 14% received rabeprazole), amoxicillin (1 g), and clarithromycin', 'proton pump inhibitor', 'bismuth salts', 'clarithromycin and amoxicillin', 'bismuth and the standard, clarithromycin-containing triple therapy', 'Bismuth and Standard Triple Therapy', 'omeprazole']","['Adverse events', 'Eradicates Helicobacter pylori Infection', 'Intention to treat eradication', 'effectiveness and safety', 'Intention to treat and per-protocol rates of eradication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",,0.104376,"In multivariate analysis, eradication was associated with treatment compliance (odds ratio [OR], 13.0), a double dose (equivalent to 40 mg omeprazole) of proton pump inhibitor (OR, 4.7), and 14-day duration of treatment (OR, 2.0).
","[{'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'McNicholl', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Dmitry S', 'Initials': 'DS', 'LastName': 'Bordin', 'Affiliation': 'Department of Pancreatobiliary and Upper GI Diseases, Moscow Clinical Scientific Center, Moscow, Russia.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lucendo', 'Affiliation': 'Department of Gastroenterology, Hospital General de Tomelloso and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Tomelloso, Spain.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Fadeenko', 'Affiliation': 'Digestive Ukrainian Academy of Medical Sciences, Kyiv, Ukraine.'}, {'ForeName': 'Manuel Castro', 'Initials': 'MC', 'LastName': 'Fernandez', 'Affiliation': 'Digestive Unit, Hospital de Valme, Sevilla, Spain.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Voynovan', 'Affiliation': 'Digestive Unit, Moscow Clinical Scientific Center Named After A.S. Loginov, Moscow, Russia.'}, {'ForeName': 'Natalia Valerievna', 'Initials': 'NV', 'LastName': 'Zakharova', 'Affiliation': 'North-western State Medical University St Petersburg, Russia.'}, {'ForeName': 'Aiman Silkanovna', 'Initials': 'AS', 'LastName': 'Sarsenbaeva', 'Affiliation': 'Gastroenterologist Department of Regional Clinical Hospital №3, Chelyabinsk, Russia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bujanda', 'Affiliation': 'Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Universidad del País Vasco, San Sebastián, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Perez-Aisa', 'Affiliation': 'Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Liudmila', 'Initials': 'L', 'LastName': 'Vologzhanina', 'Affiliation': 'Gastroenterology Unit Gastrocentr, Perm, Russia.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Zaytsev', 'Affiliation': 'First Clinical Medical Centre, Kovrov, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Ilchishina', 'Affiliation': 'SM-Clinic, Saint-Petersburg, Russia.'}, {'ForeName': 'Cristobal de la', 'Initials': 'C', 'LastName': 'Coba', 'Affiliation': 'Hospital de Cabueñes, Asturias, Spain.'}, {'ForeName': 'Jorge Perez', 'Initials': 'JP', 'LastName': 'Lasala', 'Affiliation': 'Digestive Service, HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Alekseenko', 'Affiliation': 'Far Eastern State Medical University, Khabarovsk, Khabarovsk Krai, Russia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Modolell', 'Affiliation': 'Consorci Sanitari de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Molina-Infante', 'Affiliation': 'Hospital San Pedro de Alcántara and CIBEREHD, Cáceres, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ruiz-Zorrilla Lopez', 'Affiliation': 'Hospital de Sierrallana, Torrelavega, Spain.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Alonso-Galan', 'Affiliation': 'Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Universidad del País Vasco, San Sebastián, Spain.'}, {'ForeName': 'Nuria Fernandez', 'Initials': 'NF', 'LastName': 'Moreno', 'Affiliation': 'Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Hinojosa', 'Affiliation': 'Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Santaella', 'Affiliation': 'Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Varela', 'Affiliation': 'Hospital de Cabueñes, Asturias, Spain.'}, {'ForeName': 'Pedro Luis', 'Initials': 'PL', 'LastName': 'Gonzalez-Cordero', 'Affiliation': 'Hospital San Pedro de Alcántara and CIBEREHD, Cáceres, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Barrio', 'Affiliation': 'Gastroenterology Unit, Rio Hortega University Hospital, Valladolid, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Dominguez-Jimenez', 'Affiliation': 'Gastroenterology Unit, Hospital Alto Guadalquivir, Jaen, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nuñez', 'Affiliation': 'Gastroenterology Unit, Clinica Nuestra Señora del Rosario, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alcedo', 'Affiliation': 'Gastroenterology Unit, Hospital de Barbastro, Huesca, Spain.'}, {'ForeName': 'Olga P', 'Initials': 'OP', 'LastName': 'Nyssen', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caldas', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Donday', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Shvetz', 'Affiliation': 'Medical University, Kyiv, Ukraine.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Megraud', 'Affiliation': 'Laboratoire de Bactériologie, Hôpital Pellegrin, Bordeaux, France.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': ""O'Morain"", 'Affiliation': 'Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Javier P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain. Electronic address: javier.p.gisbert@gmail.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.03.048']
724,31311427,"Regular changes in foot strike pattern during prolonged downhill running do not influence neuromuscular, energetics, or biomechanical parameters.","Research has suggested that a high variability in foot strike pattern during downhill running is associated with lower neuromuscular fatigue of the plantar flexors (PF). Given the popularity of trail running, we designed an intervention study to investigate whether a strategy with regular changes in foot strike pattern during downhill running could reduce the extent of fatigue on neuromuscular, energetics and biomechanical parameters as well as increase an uphill time-to-exhaustion trial (TTE) performance. Fourteen experienced trail runners completed two interventional conditions (separated by 15 days) in a pseudo-randomised and counter-balanced order that consisted of 2.5-h of treadmill graded running with (switch condition) or without (control condition) a change between fore- and rear-foot strike pattern every 30 s during the downhill sections. Pre and Post, neuromuscular tests were performed to assess PF central and peripheral fatigue. Energy cost of running was assessed using an indirect calorimetry system and biomechanical gait parameters were acquired with an instrumented treadmill. TTE was performed after both the graded running conditions. There were not significant condition × time interactions ( p  ≥ .085) for any of the variables considered, and TTE was not different between the two conditions ( p  = .755). A deliberate strategy to alternate between foot strike patterns did not reduce the extent of fatigue during prolonged graded running. We suggest that it is not the ability to switch between foot strike patterns that minimises fatigue; rather the ability to adapt foot strike pattern to the terrain and therefore a better running technique.",2020,"There were not significant condition × time interactions ( p  ≥ .085) for any of the variables considered, and TTE was not different between the two conditions ( p  = .755).",['Fourteen experienced trail runners'],"['TTE', 'counter-balanced order that consisted of 2.5-h of treadmill graded running with (switch condition) or without (control condition) a change between fore- and rear-foot strike pattern every 30 s during the downhill sections']","['PF central and peripheral fatigue', 'uphill time-to-exhaustion trial (TTE) performance']","[{'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0038452', 'cui_str': 'Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]",14.0,0.036663,"There were not significant condition × time interactions ( p  ≥ .085) for any of the variables considered, and TTE was not different between the two conditions ( p  = .755).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Vernillo', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Aguiar', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Savoldelli', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Giandolini', 'Affiliation': 'Salomon SAS, Innovation and Sport Science Lab, Annecy, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Horvais', 'Affiliation': 'Salomon SAS, Innovation and Sport Science Lab, Annecy, France.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Edwards', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}]",European journal of sport science,['10.1080/17461391.2019.1645212']
725,31230119,Prevention of post-traumatic osteoarthritis after intra-articular knee fractures using hyaluronic acid: a randomized prospective pilot study.,"PURPOSE


Based on the irreversible destruction of hyaline cartilage, post-traumatic osteoarthritis (PTOA) is a notorious sequelae after intra-articular knee fractures. This study evaluates the clinical efficacy and applicability of immediate post-operative intra-articular injection of hyaluronic acid (IA HA) into the knee joint with an intra-articular fracture.
METHODS


Prospective randomized case-control study involving 40 patients (20 in each group) with intra-articular knee fracture with an average follow-up of 23 months (range 18-24 months). Twenty patients with intra-articular distal femoral or intra-articular proximal tibial fractures who met our inclusion criteria received three intra-articular hyaluronic acid injections weekly starting immediately after ORIF. Another 20 patients serving as a control group received no injection after ORIF. Patients were assessed functionally with Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) score. Plain X-rays and when indicated CT scans were used to assess radiological union.
RESULTS


The results showed patients treated with intra-articular hyaluronic acid injection after fixation had significantly less pain (KOOS) (p = 0.01). No significant difference was found between both groups in other KOOS-related outcome measures, complications, functional outcome, or quality of life.
CONCLUSIONS


These preliminary results support a direct role for hyaluronic acid in the acute phase of the inflammatory process that follows articular injury and provides initial evidence for the efficacy of IA HA.",2019,"No significant difference was found between both groups in other KOOS-related outcome measures, complications, functional outcome, or quality of life.
","['Twenty patients with intra-articular distal femoral or intra-articular proximal tibial fractures who met our inclusion criteria received three', '40 patients (20 in each group) with intra-articular knee fracture with an average follow-up of 23\xa0months (range 18-24\xa0months']","['intra-articular hyaluronic acid injections weekly starting immediately after ORIF', 'immediate post-operative intra-articular injection of hyaluronic acid (IA HA', 'Plain X-rays and when indicated CT scans', 'hyaluronic acid', 'control group received no injection after ORIF']","['complications, functional outcome, or quality of life', 'pain (KOOS', 'Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205449', 'cui_str': 'Three'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0745541', 'cui_str': 'Knee fracture'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",40.0,0.0277595,"No significant difference was found between both groups in other KOOS-related outcome measures, complications, functional outcome, or quality of life.
","[{'ForeName': 'Ahmed Samir', 'Initials': 'AS', 'LastName': 'Barakat', 'Affiliation': 'Orthopedics and Trauma Department, Cairo University, Cairo, Egypt. ahmedsamir222222@live.com.'}, {'ForeName': 'Nour Muhamad', 'Initials': 'NM', 'LastName': 'Ibrahim', 'Affiliation': 'Orthopedics and Trauma Department, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Elghobashy', 'Affiliation': 'Orthopedics Department, Sligo University Hospital, Sligo, Ireland.'}, {'ForeName': 'Ahmed Maher', 'Initials': 'AM', 'LastName': 'Sultan', 'Affiliation': 'Orthopedics and Trauma Department, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled F M', 'Initials': 'KFM', 'LastName': 'Abdel-Kader', 'Affiliation': 'Orthopedics and Trauma Department, Cairo University, Cairo, Egypt.'}]",International orthopaedics,['10.1007/s00264-019-04360-8']
726,31324544,Preparing pregnancy through Preconception Education Training.,"OBJECTIVE


This study aimed to identify the effectiveness of preconception education on unmarried women in preparing for pregnancy.
METHOD


A quasi-experimental pre and posttest with control group study included 92 unmarried women in West Java, Indonesia, which were selected by consecutive sampling. Each respondent in the intervention group was provided a preconception education consisting of preconception physical health, nutrition, and lifestyle topic with a booklet.
RESULTS


This study indicated a significant difference in post-intervention scores, with the intervention group scoring higher than the control group in overall preconception health knowledge such as physical health (p<0.001), nutrition (p<0.001), and lifestyle (p<0.001). In terms of intra-group score analysis between pre and post intervention, there were significant changes within the intervention group in the knowledge of physical health (p<0.001), nutrition (p<0.001), and lifestyle (p<0.001). The most significant changes in knowledge occur in preconception nutrition (53.5%) followed by preconception lifestyle (20.1%) and preconception physical health (11.8%). Within the control group, there was no significant change from pre and post intervention in scores for overall preconception health knowledge.
CONCLUSION


This study recommended to use this preconception education to increase the knowledge related to preconception health of the unmarried women whether they plan to have a child soon or postpone the pregnancy after marriage.",2019,"Within the control group, there was no significant change from pre and post intervention in scores for overall preconception health knowledge.
","['unmarried women in preparing for pregnancy', 'A quasi-experimental pre and posttest with control group study included 92 unmarried women in West Java, Indonesia, which were selected by consecutive sampling']","['preconception education', 'preconception education consisting of preconception physical health, nutrition, and lifestyle topic with a booklet']","['preconception physical health', 'overall preconception health knowledge such as physical health', 'knowledge of physical health (p<0.001), nutrition (p<0.001), and lifestyle', 'knowledge occur in preconception nutrition']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",,0.0201432,"Within the control group, there was no significant change from pre and post intervention in scores for overall preconception health knowledge.
","[{'ForeName': 'Ika Fauziah', 'Initials': 'IF', 'LastName': 'Priani', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Yati', 'Initials': 'Y', 'LastName': 'Afiyanti', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: yatikris@ui.ac.id.'}, {'ForeName': 'Wiwit', 'Initials': 'W', 'LastName': 'Kurniawati', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.140']
727,31849155,Effects of nicorandil infusion on ECG parameters in patients with unstable angina pectoris and percutaneous coronary intervention.,"BACKGROUND


Percutaneous coronary intervention (PCI) is effective in treating patients with acute coronary syndrome (ACS) but is associated with some serious complications. Nicorandil is an anti-anginal agent acting to improve microvascular circulation and to increase coronary blood flow. The objective of this article is to evaluate the effects of intracoronary injection followed with continuous intravenous injection of nicorandil on ECG parameters in patients with unstable angina pectoris (UA) undergoing PCI.
METHODS


A single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019. Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled. ECG was recorded and analyzed before and 24 hr after nicorandil infusion.
RESULTS


Patients were divided into three groups: control group (n = 23, aged 63.43 ± 12.55 years), short-term, and prolonged use with nicorandil group (n = 20 and 20, aged 66.45 ± 8.06 years and 65.80 ± 9.49 years, respectively). Clinical characteristics and ECG parameters were similar before PCI among three groups (p > .05). In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
CONCLUSIONS


Nicorandil infusion reduces QTd and Tp-e interval in patients with UA. Further studies will be needed to determine whether these electrophysiological changes are associated with a reduction of ventricular arrhythmias and improved outcomes.",2020,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","['patients with unstable angina pectoris and percutaneous coronary intervention', 'patients with unstable angina pectoris (UA) undergoing PCI.\nMETHODS\n\n\nA single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019', 'patients with acute coronary syndrome (ACS', 'Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled', 'Patients were divided into three groups: control group (n\xa0=\xa023, aged 63.43\xa0±\xa012.55\xa0years), short-term, and prolonged use with nicorandil group (n\xa0=\xa020 and 20, aged 66.45\xa0±\xa08.06\xa0years and 65.80\xa0±\xa09.49\xa0years, respectively', 'patients with UA']","['Percutaneous coronary intervention (PCI', 'nicorandil', 'nicorandil infusion', 'Nicorandil', 'intracoronary injection']","['coronary blood flow', 'intervals of QTd and Tp-e', 'QTd and Tp-e interval', 'Clinical characteristics and ECG parameters', 'ECG parameters', 'ECG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",63.0,0.0131258,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05).
","[{'ForeName': 'Weiding', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kangyin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tse', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12736']
728,31268466,Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction.,"Importance


Percutaneous coronary intervention (PCI) of nonculprit vessels among patients with ST-segment elevation myocardial infarction (STEMI) is associated with improved clinical outcome compared with culprit vessel-only PCI. Fractional flow reserve (FFR) and coronary flow reserve are hyperemic indices used to guide revascularization. Recently, instantaneous wave-free ratio was introduced as a nonhyperemic alternative to FFR. Whether these indices can be used in the acute setting of STEMI continues to be investigated.
Objective


To assess the value of hemodynamic indices in nonculprit vessels of patients with STEMI from the index event to 1-month follow-up.
Design, Setting, and Participants


This substudy of the Reducing Micro Vascular Dysfunction in Revascularized STEMI Patients by Off-target Properties of Ticagrelor (REDUCE-MVI) randomized clinical trial enrolled 98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel. Patient enrollment was between May 1, 2015, and September 19, 2017. After successful primary PCI, nonculprit intracoronary hemodynamic measurements were performed and repeated at 1-month follow-up. Cardiac magnetic resonance imaging was performed from 2 to 7 days and 1 month after primary PCI.
Main Outcomes and Measures


The value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance from the index event to 1-month follow-up.
Results


Of 73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years. Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06]; P = .12) and there was no change in resting distal pressure/aortic pressure (mean [SD], 0.94 [0.06] vs 0.95 [0.06]; P = .25) from the acute moment to 1-month follow-up. The FFR decreased (mean [SD], 0.88 [0.07] vs 0.86 [0.09]; P = .001) whereas coronary flow reserve increased (mean [SD], 2.9 [1.4] vs 4.1 [2.2]; P < .001). Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance increased from the acute moment to follow-up. The decrease in distal pressure from rest to hyperemia was smaller at the acute moment vs follow-up (mean [SD], 10.6 [11.2] mm Hg vs 14.1 [14.2] mm Hg; P = .05). This blunted acute hyperemic response correlated with final infarct size (ρ, -0.29; P = .02). The resistive reserve ratio was lower at the acute moment vs follow-up (mean [SD], 3.4 [1.7] vs 5.0 [2.7]; P < .001).
Conclusions and Relevance


In the acute setting of STEMI, nonculprit coronary flow reserve was reduced and FFR was augmented, whereas instantaneous wave-free ratio was not altered. These results may be explained by an increased hyperemic microvascular resistance and a blunted adenosine responsiveness at the acute moment that was associated with infarct size.",2019,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"['73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years', 'Patients With ST-Segment Elevation Myocardial Infarction', 'patients with ST-segment elevation myocardial infarction (STEMI', '98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel', 'nonculprit vessels of patients with STEMI from the index event to 1-month follow-up']","['Percutaneous coronary intervention (PCI', 'Ticagrelor', 'Cardiac magnetic resonance imaging']","['resistive reserve ratio', 'Fractional flow reserve (FFR) and coronary flow reserve', 'Coronary Hyperemic and Resting Hemodynamic Indices', 'distal pressure', 'resting distal pressure/aortic pressure', 'blunted acute hyperemic response', 'coronary flow reserve', 'value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance', 'Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance', 'Instantaneous wave-free ratio (SD', 'FFR', 'hyperemic microvascular resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",98.0,0.0728239,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"[{'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Guus A', 'Initials': 'GA', 'LastName': 'de Waard', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Broyd', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Casper W H', 'Initials': 'CWH', 'LastName': 'Beijnink', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ten Cate', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Department of Cardiology, Hospital Clínico San Carlos El Instituto de Investigación Sanitaria del Hospital Clinic San Carlos and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2138']
729,31302043,Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial.,"OBJECTIVES


This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date.
BACKGROUND


There are limited data characterizing HRQL in patients with HFpEF using validated metrics.
METHODS


The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45%) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison.
RESULTS


In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly.
CONCLUSIONS


HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255).",2019,Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001).,"['HF trial patients', 'Heart Failure', 'patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart\xa0Failure) trial', '≥50 years of age to either', '50\xa0years of age were excluded to enable comparison', '4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization', 'symptomatic patients with HFpEF (≥45']","['Kansas City Cardiomyopathy Questionnaire (KCCQ', 'HFpEF', 'Fraction', 'sacubitril/valsartan or valsartan']","['KCCQ scores', 'KCCQ-OS score', 'Health-Related Quality of Life in Heart', 'baseline health-related quality of life (HRQL', 'mean KCCQ-OS score', 'Global Mortality and Morbidity', 'Mean KCCQ-OS score', 'adverse HRQL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",4822.0,0.186732,Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001).,"[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore Medical School, Singapore; George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas; Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine, Cardiology Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; German Heart Center, Berlin, Germany.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm CIC 1433, French Clinical Research Infrastructure Network, Investigation Network Initiative Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régionale Universitaire de Nancy, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.05.015']
730,31324546,Assertiveness training and family psychoeducational therapies on adolescents mental resilience in the prevention of drug use in boarding schools.,"OBJECTIVE


This study aims to determine the effect of assertiveness training and family psychoeducational therapies on adolescent mental resilience in the prevention of drug use in boarding schools.
METHOD


The research design was quasi-experimental pre-posttest with a control group. Sixty-four adolescent students at the Boarding school were selected using purposive sampling technique and cluster random sampling. The intervention group 1 only received general nursing intervention, and the intervention group 2 received general nursing intervention, assertiveness training, and family psychoeducational therapies.
RESULTS


The results showed that the mental resilience of adolescent students increased significantly after receiving nursing intervention and in the high mental resilience category (p=0.017), after assertiveness training and family psychoeducational therapies, adolescent mental resilience in the intervention group 2 increased greater than only general nursing intervention (p=0.000) with the change of high mental resilience category becomes very high mental resilience.
CONCLUSIONS


There is an influence of assertiveness training and family psychoeducational therapies on adolescent mental resilience in the prevention of drugs used in Boarding school.",2019,There is an influence of assertiveness training and family psychoeducational therapies on adolescent mental resilience in the prevention of drugs used in Boarding school.,"['Sixty-four adolescent students at the Boarding school', 'adolescents mental resilience in the prevention of drug use in boarding schools']","['nursing intervention', 'Assertiveness training and family psychoeducational therapies', 'assertiveness training and family psychoeducational therapies', 'general nursing intervention, and the intervention group 2 received general nursing intervention, assertiveness training, and family psychoeducational therapies', 'general nursing intervention']","['adolescent mental resilience', 'mental resilience of adolescent students']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0424935', 'cui_str': 'Boarding school (environment)'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0150139', 'cui_str': 'Assertiveness training (procedure)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",64.0,0.0262234,There is an influence of assertiveness training and family psychoeducational therapies on adolescent mental resilience in the prevention of drugs used in Boarding school.,"[{'ForeName': 'Indah', 'Initials': 'I', 'LastName': 'Ramadhan', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Budi Anna', 'Initials': 'BA', 'LastName': 'Keliat', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: ba_keliat@ui.ac.id.'}, {'ForeName': 'Ice Yulia', 'Initials': 'IY', 'LastName': 'Wardani', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.040']
731,31327687,"Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial.","BACKGROUND


Pomalidomide and dexamethasone is a standard of care for patients with multiple myeloma in whom bortezomib and lenalidomide treatment has failed. KEYNOTE-183 assessed efficacy and safety of pomalidomide and dexamethasone with or without pembrolizumab in patients with relapsed or refractory multiple myeloma. Here, we present the findings of an unplanned, ad-hoc interim analysis at the request of the US Food and Drug Administration (FDA).
METHODS


KEYNOTE-183 was a randomised, open-label, phase 3 trial done at 97 medical centres across 11 countries (Australia, Canada, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Spain, and USA). Patients aged at least 18 years with multiple myeloma, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, previously treated with at least two lines of therapy (excluding pomalidomide) and refractory to the last line were randomly assigned 1:1 to the pembrolizumab plus pomalidomide and dexamethasone group or the pomalidomide and dexamethasone group via an interactive voice response or integrated web response system. Patients received oral pomalidomide 4 mg daily on days 1-21 and oral low-dose dexamethasone 40 mg on days 1, 8, 15, and 22 in 28-day cycles, with or without intravenous pembrolizumab 200 mg every 3 weeks. The dual primary endpoints were progression-free survival and overall survival. Efficacy was assessed in all randomly assigned patients and safety was assessed in patients who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, number NCT02576977, and it is closed for accrual.
FINDINGS


Between Jan 18, 2016, and June 7, 2017, 249 patients were randomly assigned to either the pembrolizumab plus pomalidomide and dexamethasone group (n=125) or the pomalidomide and dexamethasone group (n=124). On July 3, 2017, the FDA established that risks associated with the triple combination outweighed benefits and halted the study. Median follow-up was 8·1 months (IQR 4·5-10·9). Median progression-free survival was 5·6 months (95% CI 3·7-7·5) in the pembrolizumab plus pomalidomide and dexamethasone group versus 8·4 months (5·9-not reached) in the pomalidomide and dexamethasone group; progression-free survival estimates at 6 months were 48% (95% CI 37-58) versus 60% (49-69) at 6 months (hazard ratio [HR] 1·53; 95% CI 1·05-2·22; p=0·98). Median overall survival was not reached (95% CI 12·9-not reached) versus 15·2 months (12·7-not reached; HR 1·61; 95% CI 0·91-2·85; p=0·95); overall survival estimates at 6 months were 82% (95% CI 74-88) versus 90% (82-95). Serious adverse events occurred in 75 (63%) of 120 patients in the pembrolizumab plus pomalidomide and dexamethasone group versus 56 (46%) of 121 patients in the pomalidomide and dexamethasone group. Four (3%) treatment-related deaths occurred in the pembrolizumab plus pomalidomide and dexamethasone group (one each of unknown cause, neutropenic sepsis, myocarditis, and Stevens-Johnson syndrome); myocarditis and Stevens-Johnson syndrome were considered related to pembrolizumab. No treatment-related deaths were reported in the pomalidomide and dexamethasone group.
INTERPRETATION


The results from this unplanned, FDA-requested, interim analysis showed that the benefit-risk profile of pembrolizumab plus pomalidomide and dexamethasone is unfavourable for patients with relapsed or refractory multiple myeloma.
FUNDING


Merck Sharp & Dohme, a subsidiary of Merck & Co (Kenilworth, NJ, USA).",2019,Median progression-free survival was 5·6 months (95% CI 3·7-7·5) in the pembrolizumab plus pomalidomide and dexamethasone group versus 8·4 months (5·9-not reached) in the pomalidomide and dexamethasone group; progression-free survival estimates at 6 months were 48% (95% CI 37-58) versus 60% (49-69) at 6 months,"['patients with relapsed or refractory multiple myeloma (KEYNOTE-183', '249 patients', 'Patients aged at least 18 years with multiple myeloma, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, previously treated with at least two lines of therapy (excluding pomalidomide) and refractory to the last line', 'patients with relapsed or refractory multiple myeloma', '97 medical centres across 11 countries (Australia, Canada, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Spain, and USA', 'patients with multiple myeloma in whom', 'Between Jan 18, 2016, and June 7, 2017']","['bortezomib and lenalidomide', 'oral pomalidomide 4 mg daily on days 1-21 and oral low-dose dexamethasone', 'pembrolizumab plus pomalidomide and dexamethasone group or the pomalidomide and dexamethasone group via an interactive voice response or integrated web response system', 'dexamethasone', 'Pembrolizumab plus pomalidomide and dexamethasone', 'pembrolizumab plus pomalidomide and dexamethasone', 'pomalidomide and dexamethasone', 'pomalidomide and dexamethasone with or without pembrolizumab']","['deaths', 'neutropenic sepsis, myocarditis, and Stevens-Johnson syndrome); myocarditis and Stevens-Johnson syndrome', 'progression-free survival estimates', 'progression-free survival and overall survival', 'Median overall survival', 'efficacy and safety', 'Serious adverse events', 'Median progression-free survival', 'Efficacy', 'overall survival estimates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3536424', 'cui_str': 'pomalidomide 4 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C4304406', 'cui_str': 'X-linked intellectual disability, macrocephaly, macroorchidism syndrome (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",249.0,0.242049,Median progression-free survival was 5·6 months (95% CI 3·7-7·5) in the pembrolizumab plus pomalidomide and dexamethasone group versus 8·4 months (5·9-not reached) in the pomalidomide and dexamethasone group; progression-free survival estimates at 6 months were 48% (95% CI 37-58) versus 60% (49-69) at 6 months,"[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Complejo Asistencial Universitario de Salamanca/IBSAL, Salamanca, Spain. Electronic address: mvmateos@usal.es.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Blacklock', 'Affiliation': 'Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital and KG Jebsen Center for B-Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Triasi Pujol, Barcelona, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Anupkumar', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Wellington Blood and Cancer Center, Wellington, New Zealand.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases in Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Chanan-Khan', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sherbenou', 'Affiliation': 'University of Colorado Cancer Center, Denver, CO, USA.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Avivi', 'Affiliation': 'Sourasky Medical Center, Haifa, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Benyamini', 'Affiliation': 'Rambam Health Care Campus, HaAliya HaShniya, Israel.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization, Shibukawa Medical Center, Shibukawa, Gunma, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross, Tokyo, Japan.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Jagannath', 'Affiliation': 'The Mount Sinai Medical Hospital, New York, NY, USA.'}, {'ForeName': 'Enrique M', 'Initials': 'EM', 'LastName': 'Ocio', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodriguez-Otero', 'Affiliation': 'Clinica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San Miguel', 'Affiliation': 'Clinica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kher', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Farooqui', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Haematology,['10.1016/S2352-3026(19)30110-3']
732,31788849,Low-dose rectal diclofenac does not prevent post-ERCP pancreatitis in low- or high-risk patients.,"BACKGROUND AND AIM


The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post-ERCP pancreatitis (PEP). Rectal nonsteroidal anti-inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high-risk patients. However, in contrast to high-risk patients, the role of NSAID administration in patients with low risk remains controversial.
METHODS


We performed a prospective, single-center, single-blinded, two-arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at-risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP.
RESULTS


A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk.
CONCLUSIONS


Prophylactic low-dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.",2020,The baseline and procedural characteristics were similar in both groups.,"['147 patients', 'at-risk patients', 'high-risk patients', 'Patients scheduled to undergo ERCP']","['diclofenac', 'Low-dose rectal diclofenac', 'endoscopic retrograde cholangiopancreatography (ERCP) procedure', 'rectal diclofenac', 'rectal NSAID administration', 'Rectal nonsteroidal anti-inflammatory drug (NSAID']","['PEP occurrence', 'incidence of PEP', 'rate of PEP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",303.0,0.0552853,The baseline and procedural characteristics were similar in both groups.,"[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Katoh', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Kousaku', 'Initials': 'K', 'LastName': 'Kawashima', 'Affiliation': 'Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Fukuba', 'Affiliation': 'Department of Internal Medicine, Izumo City General Medical Center, Izumo, Shimane, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Masuda', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kobatake', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Kousaku', 'Initials': 'K', 'LastName': 'Masaki', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Araki', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kawano', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Nishi', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Awaji Medical Center, 137-1 Shioya, Sumoto, Hyogo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Takenaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Internal Medicine II, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14948']
733,31327047,Is Bacillus coagulans supplementation plus low FODMAP diet superior to low FODMAP diet in irritable bowel syndrome management?,"PURPOSE


The aim of this study was to assess the superiority of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone in the reduction of irritable bowel syndrome (IBS) symptoms.
METHODS


In this randomized clinical trial, fifty IBS patients who met Rome IV criteria for IBS were randomly assigned to receive a low FODMAP diet plus either a probiotic or a placebo capsule for 8 weeks. Probiotic capsules contained 10 9 B. coagulans spores and 400 mg inulin, while placebo capsules consisted of 500 mg rice starch.
RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001). Moreover, the frequency of patients with clinical improvement in IBS-symptom severity scale (IBS-SSS) was significantly more in probiotic group compared to placebo group (P = 0.038).
CONCLUSION


Our results indicate that the addition of probiotic supplement containing B. coagulans to the low FODMAP diet might be superior to low FODMAP diet in alleviating IBS symptoms.",2020,"RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001).",['fifty IBS patients who met Rome IV criteria for IBS'],"['FODMAP diet superior to low FODMAP diet', 'placebo', 'low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet plus Bacillus coagulans supplementation to low FODMAP diet alone', 'low FODMAP diet plus either a probiotic or a placebo capsule', 'placebo capsules consisted of 500\xa0mg rice starch']","['severity score', 'IBS-symptom severity scale (IBS-SSS', 'irritable bowel syndrome (IBS) symptoms', 'abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0012611', 'cui_str': 'Disaccharides'}, {'cui': 'C0026492', 'cui_str': 'Simple Sugars'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0947613', 'cui_str': 'STARCH, RICE'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0034380'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",50.0,0.135522,"RESULTS


Significant improvements were observed in abdominal pain intensity and frequency, abdominal distension, satisfaction with bowel habits, quality of life, defecation consistency, and patient-reported severity score in both groups; however, only improvement in severity score was significantly higher in probiotic group compared with placebo group (P = 0.001).","[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Abhari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseini-Oskouiee', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Department of Food Technology, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Hejazi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. a_hekmat2000@yahoo.com.'}]",European journal of nutrition,['10.1007/s00394-019-02060-y']
734,31338545,A carbohydrate-reduced high-protein diet improves HbA 1c  and liver fat content in weight stable participants with type 2 diabetes: a randomised controlled trial.,"AIMS/HYPOTHESIS


Dietary recommendations for treating type 2 diabetes are unclear but a trend towards recommending a diet reduced in carbohydrate content is acknowledged. We compared a carbohydrate-reduced high-protein (CRHP) diet with an iso-energetic conventional diabetes (CD) diet to elucidate the effects on glycaemic control and selected cardiovascular risk markers during 6 weeks of full food provision of each diet.
METHODS


The primary outcome of the study was change in HbA 1c . Secondary outcomes reported in the present paper include glycaemic variables, ectopic fat content and 24 h blood pressure. Eligibility criteria were: men and women with type 2 diabetes, HbA 1c  48-97 mmol/mol (6.5-11%), age >18 years, haemoglobin >6/>7 mmol/l (women/men) and eGFR >30 ml min -1  (1.73 m) -2 . Participants were randomised by drawing blinded ballots to 6 + 6 weeks of an iso-energetic CRHP vs CD diet in an open label, crossover design aiming at body weight stability. The CRHP/CD diets contained carbohydrate 30/50 energy per cent (E%), protein 30/17E% and fat 40/33E%, respectively. Participants underwent a meal test at the end of each diet period and glycaemic variables, lipid profiles, 24 h blood pressure and ectopic fat including liver and pancreatic fat content were assessed at baseline and at the end of each diet period. Data were collected at Copenhagen University Hospital, Bispebjerg and Copenhagen University Hospital, Herlev.
RESULTS


Twenty-eight participants completed the study. Fourteen participants carried out 6 weeks of the CRHP intervention followed by 6 weeks of the CD intervention, and 14 participants received the dietary interventions in the reverse order. Compared with a CD diet, a CRHP diet reduced the primary outcome of HbA 1c  (mean ± SEM: -6.2 ± 0.8 mmol/mol (-0.6 ± 0.1%) vs -0.75 ± 1.0 mmol/mol (-0.1 ± 0.1%); p < 0.001). Nine (out of 37) pre-specified secondary outcomes are reported in the present paper, of which five were significantly different between the diets, (p < 0.05); compared with a CD diet, a CRHP diet reduced the secondary outcomes (mean ± SEM or medians [interquartile range]) of fasting plasma glucose (-0.71 ± 0.20 mmol/l vs 0.03 ± 0.23 mmol/l; p < 0.05), postprandial plasma glucose AUC (9.58 ± 0.29 mmol/l × 240 min vs 11.89 ± 0.43 mmol/l × 240 min; p < 0.001) and net AUC (1.25 ± 0.20 mmol/l × 240 min vs 3.10 ± 0.25 mmol/l × 240 min; p < 0.001), hepatic fat content (-2.4% [-7.8% to -1.0%] vs 0.2% [-2.3% to 0.9%]; p < 0.01) and pancreatic fat content (-1.7% [-3.5% to 0.6%] vs 0.5% [-1.0% to 2.0%]; p < 0.05). Changes in other secondary outcomes, i.e. 24 h blood pressure and muscle-, visceral- or subcutaneous adipose tissue, did not differ between diets.
CONCLUSIONS/INTERPRETATION


A moderate macronutrient shift by substituting carbohydrates with protein and fat for 6 weeks reduced HbA 1c  and hepatic fat content in weight stable individuals with type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02764021.
FUNDING


The study was funded by grants from Arla Food for Health; the Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen; the Department of Clinical Medicine, Aarhus University; the Department of Nutrition, Exercise and Sports, University of Copenhagen; and Copenhagen University Hospital, Bispebjerg.",2019,"240 min; p < 0.001), hepatic fat content (-2.4% [-7.8% to -1.0%]","['Eligibility criteria were: men and women with type 2 diabetes, HbA 1c  48-97\xa0mmol/mol (6.5-11%), age >18\xa0years, haemoglobin >6/>7\xa0mmol/l (women/men) and eGFR ', 'Twenty-eight participants completed the study', 'weight stable individuals with type 2 diabetes', 'Data were collected at Copenhagen University Hospital, Bispebjerg and Copenhagen University Hospital, Herlev', '30', 'weight stable participants with type 2 diabetes']","['CRHP intervention followed by 6\xa0weeks of the CD intervention', 'dietary interventions', 'carbohydrate-reduced high-protein diet', 'iso-energetic CRHP vs CD diet', 'carbohydrate-reduced high-protein (CRHP) diet with an iso-energetic conventional diabetes (CD) diet']","['blood pressure and ectopic fat including liver and pancreatic fat content', '24\xa0h blood pressure and muscle-, visceral- or subcutaneous adipose tissue', 'change in HbA 1c ', 'pancreatic fat content', 'glycaemic variables, ectopic fat content and 24\xa0h blood pressure', 'HbA 1c  and liver fat content', 'postprandial plasma glucose AUC', 'fasting plasma glucose', 'hepatic fat content']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",28.0,0.0310372,"240 min; p < 0.001), hepatic fat content (-2.4% [-7.8% to -1.0%]","[{'ForeName': 'Mads J', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark. mads.gustav.juul.skytte@regionh.dk.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Petersen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Mads N', 'Initials': 'MN', 'LastName': 'Thomsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Chabanova', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}]",Diabetologia,['10.1007/s00125-019-4956-4']
735,31310423,Roommate effects in health outcomes.,"We use randomized roommate assignment in dormitories in a college in Kolkata in India to examine peer effects in weight gains among roommates. We use administrative data on weight, height, and test scores of students at the time of college admission and then survey these students at the end of their first and second years in college. We do not find any significant roommate specific peer effect in weight gain. Our results rather suggest that an obese roommate reduces the probability that the other roommates become obese in subsequent years. We examine potential mechanism using survey data on students' eating habits, smoking, exercise, and sleeping patterns. We find that obese roommates sleep longer, which in turn improves the sleep pattern of others, which might explain the weak negative effect of obese roommates on the weight of others in the same room.",2019,We do not find any significant roommate specific peer effect in weight gain.,"['students at the time of college admission and then survey these students at the end of their first and second years in college', ""students' eating habits, smoking, exercise, and sleeping patterns""]",[],"['weight gains', 'weight gain']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1266864', 'cui_str': 'Eating habit'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0251565,We do not find any significant roommate specific peer effect in weight gain.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frijters', 'Affiliation': 'Centre for Economic Performance, London School of Economics, London, UK.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Islam', 'Affiliation': 'Department of Economics, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chitwan', 'Initials': 'C', 'LastName': 'Lalji', 'Affiliation': 'Department of Economic Sciences, Indian Institute of Technology Kanpur, Kanpur, India.'}, {'ForeName': 'Debayan', 'Initials': 'D', 'LastName': 'Pakrashi', 'Affiliation': 'Department of Economic Sciences, Indian Institute of Technology Kanpur, Kanpur, India.'}]",Health economics,['10.1002/hec.3901']
736,31319398,A Group Dynamics-Based Exercise Intervention to Improve Physical Activity Maintenance in Breast Cancer Survivors.,"BACKGROUND


To maintain increases in physical activity (PA), interventions that implement group dynamics principles and strategies with the intent of enhancing group cohesion may be advantageous. This study examined group cohesion and PA following a group dynamics-based PA intervention among breast cancer survivors.
METHODS


The study was designed as a pilot randomized controlled trial comparing an 8-week group dynamics-based intervention with an individually supervised intervention. Group cohesion was measured by the Physical Activity Group Environment Questionnaire, and PA was measured at baseline, post-intervention, and 3-month follow-up using a self-report questionnaire and pedometer.
RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555). At 3-month follow-up, 91.7% of participants in the group-dynamics-based intervention (n = 12) were classified as moderately active or greater, compared with 54.5% in the individually supervised intervention (n = 11).
CONCLUSIONS


These results suggest that, for breast cancer survivors, peer support and fostering group cohesion as part of an exercise program may help to support PA following the completion of a structured intervention. A larger trial with longer follow-up is needed to establish comparative efficacy for a group-dynamics-based exercise intervention to enhance long-term PA adherence in breast cancer survivors.",2019,"RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","['breast cancer survivors', 'Breast Cancer Survivors']","['Exercise Intervention', 'exercise intervention', 'PA following a group dynamics-based PA intervention']","['Physical Activity Group Environment Questionnaire, and PA', 'Physical Activity Maintenance']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.0254624,"RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leach', 'Affiliation': ''}, {'ForeName': 'Katie B', 'Initials': 'KB', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Hidde', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0667']
737,32208125,Melatonin a Promising Candidate for DNA Double-Stranded Breaks Reduction in Patients Undergoing Abdomen-Pelvis Computed Tomography Examinations.,"BACKGROUND AND OBJECTIVE


Cancer incidence is 24% higher in children and young adults exposed to Computed Tomography (CT) scans than those unexposed. Non-repairing of ionizing radiation-induced DNA Double-Strand Breaks (DSBs) can initiate carcinogenesis. In the present study, we aimed to investigate the radioprotective potential of melatonin against DSBs in peripheral blood lymphocytes of patients undergoing abdomen-pelvis CT examinations.
METHODS


This double-blind, placebo-controlled clinical trial was conducted on thirty patients. These patients were divided into two groups; group one (control) patients who have undergone the CT examination received a single oral dose of placebo, while in group two, patients received a single oral dose of 100mg melatonin. In both the groups, blood samples were collected 5-10min before and 30 minutes after the CT examination. The lymphocytes from these samples were isolated and DSBs were analyzed using γH2AX immunofluorescence microscopy.
RESULTS


Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs. In addition, no side effect was observed in patients following 100mg melatonin administration.
CONCLUSION


For the first time, this study has shown that melatonin has protective effects against radiationinduced genotoxicity in peripheral blood lymphocytes of patients undergoing abdomen-pelvis CT examinations. Therefore, melatonin can be considered as a promising candidate for reducing DSBs in patients undergoing abdomen-pelvis CT examinations.",2020,"Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs.","['Patients Undergoing Abdomen-Pelvis Computed Tomography Examinations', 'patients undergoing the abdomen-pelvis CT examinations', 'thirty patients', 'children and young adults', 'patients undergoing abdomen-pelvis CT examinations']","['placebo', 'single oral dose of 100mg melatonin', 'Computed Tomography (CT) scans', 'Melatonin', 'ionizing radiation-induced DNA double-Strand Breaks (DSBs', 'melatonin', 'melatonin against DSBs']","['DSBs', 'γH2AX-foci', 'blood samples', 'peripheral blood lymphocytes', 'side effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0034538', 'cui_str': 'Ionizing radiation (physical force)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks (finding)'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",30.0,0.146628,"Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eskandari', 'Affiliation': 'Department of Medical Radiation Engineering, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Mahmoudzadeh', 'Affiliation': 'Department of Biosciences and Biotechnology, Malek-Ashtar University of Technology, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shirazi', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, Faculty of Medicine, Tehran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Esmaely', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, Faculty of Medicine, Tehran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Carnovale', 'Affiliation': 'Department of Biomedical and Clinical Sciences L. Sacco, Unit of Clinical Pharmacology, ASST Fatebenefratelli-Sacco University Hospital, Università di Milano, Milan, Italy.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Cheki', 'Affiliation': 'Department of Radiologic Technology, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Anti-cancer agents in medicinal chemistry,['10.2174/1871521409666200324101701']
738,31310993,Feasibility of a Home-Based Balance Intervention in Middle-Aged Women Using Wii Fit Plus®.,"BACKGROUND


This study evaluated the feasibility and effectiveness of a home-based exercise intervention using the Wii Fit Plus®.
METHODS


A randomized, controlled trial of 24 women (age 53.6 [5.4] y) was used to assess compliance and changes in balance over 12 weeks. Balance was measured via the Berg Balance Scale and Frailty and Injuries: Cooperative Studies of Intervention Techniques-4 Scale at baseline and week 6 and week 12. Participant compliance to the intervention was captured via paper logs and the electronic record collected by the Wii Fit Plus®.
RESULTS


Participants in the intervention group were 95% compliant based on electronic records. There were no significant differences between groups for total score on either balance scale. There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
CONCLUSIONS


The results suggest that the Wii Fit Plus® is appropriate for home-based interventions in middle-aged women. Modest improvements in balance indicate that this may be an effective means to improve or maintain balance in older women. More research is needed to determine compliance and benefits to reducing fall risk in durations exceeding 12 weeks.",2019,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
","['middle-aged women', 'Participants in the intervention group were 95% compliant based on electronic records', 'older women', '24 women (age 53.6 [5.4]\xa0y', 'Middle-Aged Women Using Wii Fit Plus®']","['Home-Based Balance Intervention', 'home-based exercise intervention']","['average velocity', 'total score on either balance scale', 'maximum velocity y']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}]",,0.043176,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Wherry', 'Affiliation': ''}, {'ForeName': 'Cheryl Der', 'Initials': 'C', 'LastName': 'Ananian', 'Affiliation': ''}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Swan', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0265']
739,31310990,Effect of Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise on Markers of Metabolic Syndrome in Adults With Excess Body Fat: A Crossover Trial.,"BACKGROUND


This study analyzed the effect of walking breaks or low-volume high-intensity interval exercise (LV-HIIE) on markers of metabolic syndrome relative to a day of prolonged sitting.
METHODS


Twenty-five adults with excess body fat participated in this crossover trial: (1) 10-hour sitting day (SIT), (2) LV-HIIE followed by a sitting day (EX+SIT), and (3) sitting day with 5-minute walking breaks for every 20 minutes (SIT+WB). Glucose and blood pressure (BP) were measured before and 1 hour after 4 meals and 2 hours after lunch. Triglycerides were measured at baseline, 2, and 3.5 hours after lunch. Generalized mixed models were used to identify differences in the area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides among the sessions.
RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2). AUC-diastolic BP was lower in SIT+WB than SIT (β = -14.1 mm Hg·10 h; 95% confidence interval, -26.5 to -1.6) and EX+SIT (β = -14.5 mm Hg·10 h; 95% confidence interval, -26.9 to -2.1). There were no differences in triglycerides and systolic BP levels among the sessions.
CONCLUSION


Adults with excess body fat present lower glucose and diastolic BP during a day with breaks in sitting time compared with a prolonged sitting day with or without an LV-HIIE session.",2019,"RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","['Twenty-five adults with excess body fat participated in this crossover trial', 'Adults With Excess Body Fat']","['Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise', 'walking breaks or low-volume high-intensity interval exercise (LV-HIIE']","['Glucose and blood pressure (BP', 'area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides', 'AUC-diastolic BP', 'Triglycerides', 'glucose and diastolic BP', 'iAUC-glucose', 'triglycerides and systolic BP levels']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",25.0,0.111075,"RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","[{'ForeName': 'Yuri Alberto', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': ''}, {'ForeName': 'Geovani de Araújo Dantas de', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': ''}, {'ForeName': 'Rodrigo Alberto Vieira', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Luiz Fernando', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': ''}, {'ForeName': 'Ágnes Denise de Lima', 'Initials': 'ÁDL', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': ''}, {'ForeName': 'José Cazuza de', 'Initials': 'JC', 'LastName': 'Farias Júnior', 'Affiliation': ''}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Boreskie', 'Affiliation': ''}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Duhamel', 'Affiliation': ''}, {'ForeName': 'Eduardo Caldas', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0492']
740,31310991,Randomized Controlled Trial of Primary Health Care Strategies for the Promotion of Leisure-Time Physical Activity Among Older Brazilians.,"BACKGROUND


Physical activity promotion within primary health care is in the spotlight. However, few studies have evaluated the long-term effectiveness of possible interventions. This study aimed to compare the effectiveness of 3 primary health care interventions in increasing leisure-time physical activity among older Brazilians.
METHODS


Experimental study with 142 older residents of an ongoing urban cohort in São Paulo (Brazil). Participants were randomized into 3 groups: minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG). We used the long version of the International Physical Activity Questionnaire to assess leisure-time physical activity at baseline, 4 years after baseline without any intervention, 3 months after intervention, and 6 months after intervention. Statistical analysis included repeated analysis of variance.
RESULTS


At baseline, 31% of the individuals were active, and this figure remained stable for a period of 4 years. Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
CONCLUSION


Results indicate that interventions with CRG are effective in producing sustained changes in physical activity among older Brazilians.",2019,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
","['142 older residents of an ongoing urban cohort in São Paulo (Brazil', 'Older Brazilians', 'older Brazilians']","['minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG', '3 primary health care interventions']",['leisure-time physical activity for CRG'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0270923,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
","[{'ForeName': 'Francini Vilela', 'Initials': 'FV', 'LastName': 'Novais', 'Affiliation': ''}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Simoes', 'Affiliation': ''}, {'ForeName': 'Chester', 'Initials': 'C', 'LastName': 'Schmaltz', 'Affiliation': ''}, {'ForeName': 'Luiz R', 'Initials': 'LR', 'LastName': 'Ramos', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2017-0502']
741,31315940,Effects of high-intensity interval training on platelet function in cardiac rehabilitation: a randomised controlled trial.,"OBJECTIVE


To compare effects of moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) on platelet function in patients undergoing cardiac rehabilitation, as hyper-reactive platelets are involved in atherogenesis and atherothrombosis.
METHODS


In this single-centre parallel group randomised controlled trial, male patients after an acute coronary syndrome under dual antiplatelet therapy performed MICT or HIIT+MICT for 12 weeks. Main outcome was platelet reactivity measured by the half-maximal concentration (EC 50 ) of platelet agonist thrombin receptor-activating peptide-6 (TRAP-6) in terms of P-selectin expression. EC 50  was determined at baseline, after 6 and 12 weeks, each time at physical rest and on exertion.
RESULTS


82 patients were randomised to MICT or HIIT+MICT. Mean (95% CI) baseline EC 50 values at physical rest were 6.7 µM (6.3 µM to 7.0 µM) TRAP-6. After 6/12 weeks, 36/33 MICT and 34/28 HIIT+MICT patients were examined. HIIT+MICT patients had 0.9 µM (0.4 µM to 1.4 µM)/0.5 µM (-0.1 µM to 1.0 µM) higher EC 50 values than MICT ones, and the propensity of their platelets to form aggregates with monocytes was significantly lower after 12 weeks. Short-term strenuous physical exertion was generally associated with platelet activation and an EC 50 reduction of 0.7 µM (0.6 µM to 0.8 µM). HIIT+MICT patients tended to be fitter after 12 weeks. No serious harms were observed.
CONCLUSIONS


Including HIIT in cardiac rehabilitation seems to confer additional benefits compared with MICT alone, which should be confirmed in clinical trials with hard endpoints. Exertion-induced platelet activation and hyper-reactivity occur despite dual antiplatelet therapy.
TRIAL REGISTRATION NUMBER


NCT02930330; Results.",2020,Short-term strenuous physical exertion was generally associated with platelet activation and an EC 50 reduction of 0.7 µM (0.6 µM to 0.8 µM).,"['82 patients', 'patients undergoing cardiac rehabilitation, as hyper-reactive platelets', 'cardiac rehabilitation', 'male patients after an acute coronary syndrome under dual antiplatelet therapy performed MICT or HIIT+MICT for 12 weeks']","['MICT or HIIT+MICT', 'moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT', 'MICT', 'HIIT+MICT', 'high-intensity interval training']","['Exertion-induced platelet activation and hyper-reactivity', 'propensity of their platelets to form aggregates with monocytes', 'platelet reactivity measured by the half-maximal concentration (EC 50 ) of platelet agonist thrombin receptor-activating peptide-6 (TRAP-6', 'platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0219419', 'cui_str': 'thrombin receptor activating peptide-6'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}]",50.0,0.11419,Short-term strenuous physical exertion was generally associated with platelet activation and an EC 50 reduction of 0.7 µM (0.6 µM to 0.8 µM).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Heber', 'Affiliation': 'Institute of Physiology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Fischer', 'Affiliation': 'Institute of Physiology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Sallaberger-Lehner', 'Affiliation': 'CARDIOMED Centre for Outpatient Cardiac Rehabilitation, Linz, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hausharter', 'Affiliation': 'Institute of Sport Science, University of Vienna, Centre of Sports Science and University Sports, Wien, Austria.'}, {'ForeName': 'Helmuth', 'Initials': 'H', 'LastName': 'Ocenasek', 'Affiliation': 'CARDIOMED Centre for Outpatient Cardiac Rehabilitation, Linz, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gleiss', 'Affiliation': 'Section for Clinical Biometrics, Medical University of Vienna, Centre for Medical Statistics Informatics and Intelligent Systems, Wien, Austria.'}, {'ForeName': 'Michael J M', 'Initials': 'MJM', 'LastName': 'Fischer', 'Affiliation': 'Institute of Physiology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Rochus', 'Initials': 'R', 'LastName': 'Pokan', 'Affiliation': 'Institute of Sport Science, University of Vienna, Centre of Sports Science and University Sports, Wien, Austria.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Assinger', 'Affiliation': 'Institute of Vascular Biology and Thrombosis Research, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Volf', 'Affiliation': 'Institute of Physiology, Medical University of Vienna, Wien, Austria.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315130']
742,31304694,Effect of transportation method on preoperative anxiety in children: a randomized controlled trial.,"BACKGROUND


This study was performed to evaluate the effect of a wagon as a transport vehicle instead of the standard stretcher car to reduce children's anxiety of separation from parents. The secondary goal was to evaluate whether this anxiolytic effect was related to age.
METHODS


We divided 80 children (age 2-7 years) into two groups. The stretcher group was transferred to the operating room on a conventional stretcher car, whereas the wagon group was transferred using a wagon. The level of anxiety was evaluated three times using the Modified Yale Preoperative Anxiety Scale (mYPAS): in the waiting area (T0), in the hallway to the operating room (T1), and before induction of anesthesia (T2).
RESULTS


The mYPAS score was significantly lower in the wagon group (36.7 [31.7, 51.7]) than in the stretcher group (51.7 [36.7, 83.3]) at T1 (P = 0.007). However, there was no difference in the mYPAS score between the two groups at T2 (46.7 [32.5, 54.2] vs. 51.7 [36.7, 75.0], respectively, P = 0.057). The baseline anxiety tended to be lower with increasing age (r = -0.248, P = 0.031). During transportation to the operating room, the increase in the mYPAS score (T1-T0) was greater as the age of children decreased in the stretcher group (r = -0.340, P = 0.034). However, no correlation was observed in the wagon group (r = -0.053, P = 0.756).
CONCLUSION


The wagon method decreased preoperative anxiety, suggesting that it may be a good alternative for reducing preoperative anxiety in children.",2020,"The baseline anxiety tended to be lower with increasing age (r = -0.248, P = 0.031).","['children', ""children's anxiety of separation from patients"", '80 children (age 2 - 7 years) into two groups']","['standard stretcher car', 'transportation method']","['preoperative anxiety', 'anxiolytic effect', 'mYPAS score', 'level of anxiety', 'Modified Yale Preoperative Anxiety Scale (mYPAS', 'baseline anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150789', 'cui_str': 'Patient Holding Stretchers'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}]",80.0,0.0253064,"The baseline anxiety tended to be lower with increasing age (r = -0.248, P = 0.031).","[{'ForeName': 'Sun-Hong', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Hong-Beom', 'Initials': 'HB', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Youngwook', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}, {'ForeName': 'Seongtae', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19191']
743,31305234,Effects of exercise intensity on anticipation timing performance during a cycling task at moderate and vigorous intensities in children aged 7-11 years.,"This study examined coincidence anticipation timing performance at moderate and fast stimulus speeds before, during, and after a 15 minute cycling task. In a within-subject design, 24 children (18 males and 6 females) exercised on a cycle ergometer under two experimental conditions: exercise intensities of 50% (moderate) and 75% (vigorous) heart rate reserve. Coincidence anticipation timing was measured using the Bassin Anticipation Timer at stimulus speeds of 5 and 8 mph. A 2 (intensity) × 3 (time) repeated measures ANOVA was conducted to evaluate the effect of exercise intensity on coincidence anticipation performance before, during, and immediately after the cycling task. Results indicated that for absolute error there was no significant main effect for time ( p  = .633) or experimental condition ( p  = .782) at the 5 mph stimulus speed. However, there was a significant interaction effect between experimental condition and time ( p  = 0.026) at the 5 mph stimulus speed. At the 8 mph stimulus speed, there was no significant main effect for time ( p  = .910) or condition ( p  = .938), or interaction effect between experimental condition and time ( p  = .591). Cycling exercise at moderate intensity appears to influence anticipation timing performance during and immediately after exercise in children, but only when stimulus speeds are moderate in nature.",2020,Results indicated that for absolute error there was no significant main effect for time ( p  = .633) or experimental condition ( p  = .782) at the 5 mph stimulus speed.,"['24 children (18 males and 6 females', 'children aged 7-11 years']","['exercised on a cycle ergometer under two experimental conditions: exercise intensities of 50% (moderate) and 75% (vigorous) heart rate reserve', 'exercise intensity', 'Cycling exercise']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],24.0,0.0252478,Results indicated that for absolute error there was no significant main effect for time ( p  = .633) or experimental condition ( p  = .782) at the 5 mph stimulus speed.,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Boat', 'Affiliation': 'Department of Sport Science, Sport, Health, and Performance Enhancement Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Morris', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}]",European journal of sport science,['10.1080/17461391.2019.1642387']
744,31294749,Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial.,"Importance


Many patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy show primary resistance. High-dose radiotherapy can lead to increased tumor antigen release, improved antigen presentation, and T-cell infiltration. This radiotherapy may enhance the effects of checkpoint inhibition.
Objective


To assess whether stereotactic body radiotherapy on a single tumor site preceding pembrolizumab treatment enhances tumor response in patients with metastatic NSCLC.
Design, Setting, and Participants


Multicenter, randomized phase 2 study (PEMBRO-RT) of 92 patients with advanced NSCLC enrolled between July 1, 2015, and March 31, 2018, regardless of programmed death-ligand 1 (PD-L1) status. Data analysis was of the intention-to-treat population.
Interventions


Pembrolizumab (200 mg/kg every 3 weeks) either alone (control arm) or after radiotherapy (3 doses of 8 Gy) (experimental arm) to a single tumor site until confirmed radiographic progression, unacceptable toxic effects, investigator decision, patient withdrawal of consent, or a maximum of 24 months.
Main Outcomes and Measures


Improvement in overall response rate (ORR) at 12 weeks from 20% in the control arm to 50% in the experimental arm with P < .10.
Results


Of the 92 patients enrolled, 76 were randomized to the control arm (n = 40) or the experimental arm (n = 36). Of those, the median age was 62 years (range, 35-78 years), and 44 (58%) were men. The ORR at 12 weeks was 18% in the control arm vs 36% in the experimental arm (P = .07). Median progression-free survival was 1.9 months (95% CI, 1.7-6.9 months) vs 6.6 months (95% CI, 4.0-14.6 months) (hazard ratio, 0.71; 95% CI, 0.42-1.18; P = .19), and median overall survival was 7.6 months (95% CI, 6.0-13.9 months) vs 15.9 months (95% CI, 7.1 months to not reached) (hazard ratio, 0.66; 95% CI, 0.37-1.18; P = .16). Subgroup analyses showed the largest benefit from the addition of radiotherapy in patients with PD-L1-negative tumors. No increase in treatment-related toxic effects was observed in the experimental arm.
Conclusions and Relevance


Stereotactic body radiotherapy prior to pembrolizumab was well tolerated. Although a doubling of ORR was observed, the results did not meet the study's prespecified end point criteria for meaningful clinical benefit. Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival. These results suggest that a larger trial is necessary to determine whether radiotherapy may activate noninflamed NSCLC toward a more inflamed tumor microenvironment.
Trial Registration


ClinicalTrials.gov identifier: NCT02492568.",2019,"Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival.","['92 patients enrolled', 'patients with metastatic NSCLC', 'Of those, the median age was 62 years (range, 35-78 years), and 44 (58%) were men', 'patients with PD-L1-negative tumors', 'Patients With Advanced Non-Small Cell Lung Cancer', 'patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy show primary resistance', '92 patients with advanced NSCLC enrolled between July 1, 2015, and March 31, 2018, regardless of programmed death-ligand 1 (PD-L1) status']","['Pembrolizumab (200 mg/kg every 3 weeks) either alone (control arm) or after radiotherapy', 'Stereotactic Body Radiotherapy vs Pembrolizumab Alone', 'Pembrolizumab', 'pembrolizumab', 'radiotherapy', 'stereotactic body radiotherapy', 'High-dose radiotherapy']","['ORR', 'Tumor Response', 'tolerated', 'tumor antigen release, improved antigen presentation, and T-cell infiltration', 'treatment-related toxic effects', 'overall response rate (ORR', 'Median progression-free survival', 'progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0041361', 'cui_str': 'Tumor Antigens'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0206431', 'cui_str': 'Antigen Presentation'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",76.0,0.351183,"Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival.","[{'ForeName': 'Willemijn S M E', 'Initials': 'WSME', 'LastName': 'Theelen', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Heike M U', 'Initials': 'HMU', 'LastName': 'Peulen', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Ferry', 'Initials': 'F', 'LastName': 'Lalezari', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van der Noort', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Jeltje F', 'Initials': 'JF', 'LastName': 'de Vries', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonology, Erasmus Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Daphne W', 'Initials': 'DW', 'LastName': 'Dumoulin', 'Affiliation': 'Department of Pulmonology, Erasmus Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Bahce', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna-Larissa N', 'Initials': 'AN', 'LastName': 'Niemeijer', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Adrianus J', 'Initials': 'AJ', 'LastName': 'de Langen', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Monkhorst', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}]",JAMA oncology,['10.1001/jamaoncol.2019.1478']
745,31302037,"Remember Me? Exposure to Unfamiliar Food Brands in Television Advertising and Online Advergames Drives Children's Brand Recognition, Attitudes, and Desire to Eat Foods: A Secondary Analysis from a Crossover Experimental-Control Study with Randomization at the Group Level.","BACKGROUND


Limitations in current Australian regulatory provisions may be identified by demonstrating the effect of different marketing methods on children's recognition and attitudes toward unhealthy food brands.
OBJECTIVE


To investigate how exposure to different marketing techniques from television (TV) and online food advertising affects children's brand recall, recognition, and attitudinal responses toward brands and brand consumers and children's desire to eat the advertised products.
DESIGN


Secondary analysis of data from a crossover experimental-control study.
PARTICIPANTS/SETTING


In all, 154 children (7 to 12 years) completed the study, conducted at four 6-day holiday camps from April 2016 to January 2017 in New South Wales, Australia. Children were assigned to a single-media (n=76) or multiple-media (n=78) condition.
INTERVENTION


All children viewed 10 TV food advertisements in a cartoon on three occasions. For one of the brands, one set of children additionally played online ""advergames"" featuring the brand.
MAIN OUTCOME MEASURES


Children's recognition and attitudes toward brands and brand consumers and children's desire to eat the product were reported via a brand recognition and attitude survey pre- and postintervention. Marketing techniques were categorized.
STATISTICAL ANALYSIS


Pre- and postintervention brand recognition and relationships between brand recognition and attitudes by media condition and desire to eat the product were examined using generalized linear mixed models and linear mixed models.
RESULTS


There was a significant increase in the number of brands recognized postexposure by children in both media groups (mean difference=3.8, P<0.0001). The majority of brands appealed to children. Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products. A larger proportion of children who played the advergames (36%) rated brand consumers as ""cool"" than children who viewed the TV advertisements only (19%) (P<0.001). Anti-adult themes, fun and humor, and parent pleasing were techniques unique to some of the most recognized and favored advertisements.
CONCLUSIONS


The marketing communications increased children's brand recognition and elicited positive attitudinal responses. These findings indicate a need for policy makers to consider additional regulations to protect children from the persuasive influence of unhealthy food advertising.",2020,Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products.,"['154 children (7 to 12 years) completed the study, conducted at four 6-day holiday camps from April 2016 to January 2017 in New South Wales, Australia']","['single-media (n=76) or multiple-media (n=78) condition', 'Unfamiliar Food Brands in Television Advertising and Online Advergames', 'marketing techniques from television (TV) and online food advertising']","[""recognition and attitudes toward brands and brand consumers and children's desire to eat the product were reported via a brand recognition and attitude survey pre- and postintervention"", ""children's brand recognition and elicited positive attitudinal responses"", 'number of brands recognized postexposure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442552', 'cui_str': 'Vacation camp'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",154.0,0.0291987,Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Norman', 'Affiliation': ''}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Anne-T', 'Initials': 'AT', 'LastName': 'McMahon', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Boyland', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'King', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.006']
746,31292752,Influence of a 3-month low-calorie Mediterranean diet compared to the vegetarian diet on human gut microbiota and SCFA: the CARDIVEG Study.,"PURPOSE


We evaluated the effect of low-calorie mediterranean (MD) and vegetarian (VD) diets on gut microbiome (GM) composition and short-chain-fatty acids (SCFA) production.
METHODS


We performed next generation sequencing (NGS) of 16S rRNA and SCFA analysis on fecal samples of 23 overweight omnivores (16 F; 7 M) with low-to-moderate cardiovascular risk. They were randomly assigned to a VD or MD, each lasting 3 months, with a crossover study design.
RESULTS


Dietary interventions did not produce significant diversity in the GM composition at higher ranks (family and above), neither between nor within MD and VD, but they did it at genus level. MD significantly changed the abundance of Enterorhabdus, Lachnoclostridium and Parabacteroides, while VD significantly affected the abundance of Anaerostipes, Streptococcus, Clostridium sensu stricto, and Odoribacter. Comparison of the mean variation of each SCFA between MD and VD showed an opposite and statistically significant trend for propionic acid (+ 10% vs - 28%, respectively, p = 0.034). In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD. Finally, correlation analyses showed a potential relationship-modulated by the two diets-between changes of genera and changes of clinical and biochemical parameters.
CONCLUSIONS


A short-term dietary intervention with MD or VD does not induce major change in the GM, suggesting that a diet should last longer than 3 months for scratching the microbial resilience. Changes in SCFA production support their role in modulating the inflammatory response, thus mediating the anti-inflammatory and protective properties of MD.",2020,"In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD.","['23 overweight omnivores (16 F; 7 M) with low-to-moderate cardiovascular risk', 'human gut microbiota and SCFA']","['low-calorie mediterranean (MD) and vegetarian (VD) diets', 'next generation sequencing (NGS) of 16S rRNA and SCFA analysis', 'vegetarian diet', 'low-calorie Mediterranean diet']","['propionic acid', 'inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12', 'abundance of Enterorhabdus, Lachnoclostridium and Parabacteroides', 'abundance of Anaerostipes, Streptococcus, Clostridium sensu stricto, and Odoribacter', 'gut microbiome (GM) composition and short-chain-fatty acids (SCFA) production', 'GM composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0562693', 'cui_str': 'Omnivore (organism)'}, {'cui': 'C1173706', 'cui_str': ""7-methoxy-6-(2'-methoxy-3'-hydroxy-3'-methyl butyl)""}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0072186', 'cui_str': 'Propionic acid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides species'}, {'cui': 'C1224225', 'cui_str': 'Anaerostipes'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C1629861', 'cui_str': 'Genus Odoribacter'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C0033268'}]",,0.0239323,"In addition, variations of SCFA were negatively correlated with changes of some inflammatory cytokines such as VEGF, MCP-1, IL-17, IP-10 and IL-12, only after MD.","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Niccolai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Pilato', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Magrini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Bartolucci', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health Section of Pharmaceutical and Nutraceutical Sciences, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Baldi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Menicatti', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health Section of Pharmaceutical and Nutraceutical Sciences, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy.'}, {'ForeName': 'Betti', 'Initials': 'B', 'LastName': 'Giusti', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Marcucci', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Rossolini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Casini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Amedei', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. amedeo.amedei@unifi.it.'}]",European journal of nutrition,['10.1007/s00394-019-02050-0']
747,31289012,An Open Fetal Myelomeningocele Repair With Incorporation of a Skin Allograft.,"BACKGROUND


Myelomeningocele (MMC) is the most frequent congenital abnormality of the central nervous system that leads to significant physical disabilities. Historically, treatment involved postnatal repair with management of the hydrocephalus with ventricular shunting. Animal and early human studies demonstrated the feasibility of fetal closure. The benefit of in-utero closure was debated until the results of the prospective randomized multicenter Management of Myelomeningocele Study (MOMS trial) were published, demonstrating a decreased need for shunting, reversal of hindbrain herniation, and better neurologic function in the prenatal repair group compared to postnatal repair. Fetal MMC closure has become a standard of care option for prenatally diagnosed spina bifida. The size of the spinal defect may require modification of the classic surgical technique requiring patching.
CASE


This report describes a case of open fetal myelomeningocele repair, which required incorporation of a skin allograft.
CONCLUSION


Large myelomeningocele defects may be successfully repaired with utilization of a skin allograft.",2020,"The benefit of in-utero closure was debated until the results of the prospective randomized multicenter Management of Myelomeningocele Study (MOMS trial) were published, demonstrating a decreased need for shunting, reversal of hindbrain herniation, and better neurologic function in the prenatal repair group compared to postnatal repair.",['prenatally diagnosed spina bifida'],['Fetal MMC closure'],['neurologic function'],"[{'cui': 'C0080178', 'cui_str': 'Schistorrhachis'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0346756,"The benefit of in-utero closure was debated until the results of the prospective randomized multicenter Management of Myelomeningocele Study (MOMS trial) were published, demonstrating a decreased need for shunting, reversal of hindbrain herniation, and better neurologic function in the prenatal repair group compared to postnatal repair.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Snegovskikh', 'Affiliation': 'Department of Anesthesiology, The Fetal Treatment Program of New England, Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: denis_snegovskikh@brown.edu.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Svokos', 'Affiliation': ""Department of Neurosurgery, The Fetal Treatment Program of New England, Rhode Island Hospital and Hasbro Children's Hospital, Warren Alpert Medical School of Brown University, Providence, RI.""}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Souza', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Western Reserve Hospital, Ohio University, Cuyahoga Falls, OH.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Renaud', 'Affiliation': ""Division of Pediatric Surgery, Department of Surgery, The Fetal Treatment Program of New England, Hasbro Children's Hospital, Warren Alpert Medical School of Brown University, Providence, RI.""}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Klinge', 'Affiliation': ""Department of Neurosurgery, The Fetal Treatment Program of New England, Rhode Island Hospital and Hasbro Children's Hospital, Warren Alpert Medical School of Brown University, Providence, RI.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Carr', 'Affiliation': 'Department of Obstetrics and Gynecology, The Fetal Treatment Program of New England, Women and Infants Hospital of Rhode Island, Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Francois I', 'Initials': 'FI', 'LastName': 'Luks', 'Affiliation': ""Division of Pediatric Surgery, Department of Surgery, The Fetal Treatment Program of New England, Hasbro Children's Hospital, Warren Alpert Medical School of Brown University, Providence, RI.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.04.015']
748,30196883,Pilot-Testing an Intervention to Enhance Wellness Policy Implementation in Schools: Wellness Champions for Change.,"OBJECTIVE


To develop and pilot-test Wellness Champions for Change (WCC) to enhance local wellness policy (LWP) implementation by forming wellness teams.
DESIGN


Randomized, controlled school-level pilot study.
SETTING


Five Maryland school districts.
PARTICIPANTS


A total of 63 elementary, middle, or high schools.
INTERVENTION(S)


Developed from stakeholder interviews, focus groups, and existing programs. Schools were randomized within district to (1) WCC training (6-hour, single-day teacher training), (2) WCC training plus technical assistance (TA), or (3) delayed training (control).
MAIN OUTCOME MEASURE(S)


Online teacher/administrator survey pre-post (spring, 1 year apart) that examined the direct effect of the intervention on active wellness team formation (postintervention, 8-item sum score) and LWP implementation (29 items, not implemented to fully implemented)/indirect effect of intervention on LWP implementation via active wellness team formation.
ANALYSIS


Adjusted linear or logistic regression and mediation modeling.
RESULTS


Postintervention, WCC plus TA and WCC had more active wellness teams (vs control, β = 1.49, P = .02 and β = 1.42, P = .03, respectively). No direct effect of intervention on LWP implementation was found. Formation of active wellness teams mediated the association between both WCC plus TA and WCC and LWP implementation (WCC plus TA confidence interval [CI], 1.22-16.25; WCC CI, 10.98-15.61 [CI was significant without 0]).
CONCLUSIONS AND IMPLICATIONS


The WCC intervention approaches indirectly affected LWP implementation through the formation of active wellness teams. These results support building and school-level wellness teams.",2018,"RESULTS


Postintervention, WCC plus TA and WCC had more active wellness teams (vs control, β = 1.49, P = .02 and β = 1.42, P = .03, respectively).","['Five Maryland school districts', 'Schools', 'A total of 63 elementary, middle, or high schools']","['WCC training (6-hour, single-day teacher training), (2) WCC training plus technical assistance (TA), or (3) delayed training (control']","['LWP implementation', 'active wellness teams']","[{'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",63.0,0.0592316,"RESULTS


Postintervention, WCC plus TA and WCC had more active wellness teams (vs control, β = 1.49, P = .02 and β = 1.42, P = .03, respectively).","[{'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD. Electronic address: ehager@peds.umaryland.edu.'}, {'ForeName': 'Hee-Jung', 'Initials': 'HJ', 'LastName': 'Song', 'Affiliation': 'Department of Nutrition and Food Science, University of Maryland, College Park, MD.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hallene H', 'Initials': 'HH', 'LastName': 'Guo', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Lea H', 'Initials': 'LH', 'LastName': 'Jaspers', 'Affiliation': 'Maryland State Department of Education, Baltimore, MD.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lopes', 'Affiliation': 'Maryland State Department of Education, Baltimore, MD.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.05.018']
749,31299247,"A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy.","BACKGROUND


The optimal mode of delivering topical anesthesia during flexible bronchoscopy remains unknown. This article compares the efficacy and safety of nebulized lignocaine, lignocaine oropharyngeal spray, or their combination.
METHODS


Consecutive subjects were randomized 1:1:1 to receive nebulized lignocaine (2.5 mL of 4% solution, group A), oropharyngeal spray (10 actuations of 10% lignocaine, group B), or nebulization (2.5 mL, 4% lignocaine) and two actuations of 10% lignocaine spray (group C). The primary outcome was the subject-rated severity of cough according to a visual analog scale. The secondary outcomes included bronchoscopist-rated severity of cough and overall procedural satisfaction on a visual analog scale, total lignocaine dose, subject's willingness to undergo a repeat procedure, adverse reactions to lignocaine, and others.
RESULTS


A total of 1,050 subjects (median age, 51 years; 64.8% men) were included. The median (interquartile range) score for subject-rated cough severity was significantly lower in group B compared to group C or group A (4 [1-10] vs 11 [4-24] vs 13 [5-30], respectively; P < .001). The bronchoscopist-rated severity of cough was also the least (P < .001), and the overall satisfaction was highest in group B (P < .001). The cumulative lignocaine dose administered was the least in group B (P < .001). A significantly higher proportion of subjects (P < .001) were willing to undergo a repeat bronchoscopy in group B (73.7%) than in groups A (49.1%) and C (59.4%). No lignocaine-related adverse events were observed.
CONCLUSIONS


Ten actuations of 10% lignocaine oropharyngeal spray were superior to nebulized lignocaine or their combination for topical anesthesia during diagnostic flexible bronchoscopy.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03109392; URL: www.clinicaltrials.gov.",2020,A significantly higher proportion of subjects (P < .001) were willing to undergo a repeat bronchoscopy in group B (73.7%) than in groups A (49.1%) and C (59.4%).,"['1,050 subjects (median age, 51 years; 64.8%\xa0men', 'Consecutive subjects']","['Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia', 'nebulized lignocaine', 'lignocaine spray', 'lignocaine', 'nebulized lignocaine, lignocaine oropharyngeal spray, or their combination', 'oropharyngeal spray (10 actuations of 10%\xa0lignocaine, group B), or nebulization (2.5\xa0mL, 4%\xa0lignocaine']","['bronchoscopist-rated severity of cough', 'adverse events', ""bronchoscopist-rated severity of cough and overall procedural satisfaction on a visual analog scale, total lignocaine dose, subject's willingness to undergo a repeat procedure, adverse reactions to lignocaine, and others"", 'subject-rated severity of cough according to a visual analog scale', 'efficacy and safety', 'overall satisfaction', 'median (interquartile range) score for subject-rated cough severity']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C4319628', 'cui_str': 'Actuation (unit of presentation)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1050.0,0.072135,A significantly higher proportion of subjects (P < .001) were willing to undergo a repeat bronchoscopy in group B (73.7%) than in groups A (49.1%) and C (59.4%).,"[{'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Babu', 'Initials': 'B', 'LastName': 'Ram', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Inderpaul Singh', 'Initials': 'IS', 'LastName': 'Sehgal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Valliappan', 'Initials': 'V', 'LastName': 'Muthu', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kuruswamy Thurai', 'Initials': 'KT', 'LastName': 'Prasad', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashutosh N', 'Initials': 'AN', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: agarwal.ritesh@outlook.in.'}]",Chest,['10.1016/j.chest.2019.06.018']
750,31802534,Target-controlled propofol infusion with or without bispectral index monitoring of sedation during advanced gastrointestinal endoscopy.,"BACKGROUND AND AIM


Target-controlled infusion (TCI) uses averaged pharmacokinetic datasets derived from population samples to automatically control the infusion rate. Bispectral index (BIS) technology non-invasively measures levels of consciousness during surgical procedures. We compared the efficacy and safety of propofol TCI with or without BIS monitoring for sedation during advanced gastrointestinal endoscopy.
METHODS


This prospective study enrolled 200 patients who were premedicated with midazolam 2 mg and alfentanil 0.4 mg before undergoing advanced gastrointestinal endoscopy. The initial target blood concentration of propofol was set at 1.0 μg/mL, and adjustments of 0.2 μg/mL were made as necessary to maintain moderate-to-deep sedation. Patients were randomized to either the BIS-blind group and evaluated for depth of anesthesia by monitoring scores of 1-2 on the Modified Observer's Assessment of Alertness/Sedation scale (n = 100) or to the BIS-open group and monitored by BIS scores of 60-80 (n = 100). The primary outcome was the total amount of propofol required to maintain anesthesia. Secondary outcomes were sedation-induced adverse events, recovery, and quality of sedation (endoscopist and patient satisfaction).
RESULTS


The mean propofol infusion rate was significantly higher in patients not monitored by BIS scores than in those who were (5.44 ± 2.12 vs 4.76 ± 1.84 mg/kg/h; P = 0.016). Levels of satisfaction were higher for endoscopists who used BIS monitoring than in those who did not.
CONCLUSIONS


Mean infusion rates were higher in propofol TCI without BIS monitoring compared with propofol TCI with BIS during advanced gastrointestinal endoscopy. Endoscopists expressed satisfaction with BIS monitoring.",2020,Mean infusion rates were higher in propofol TCI without BIS monitoring compared with propofol TCI with BIS during advanced gastrointestinal endoscopy.,"['during advanced gastrointestinal endoscopy', 'consciousness during surgical procedures', '200 patients who were premedicated with']","[""BIS-blind group and evaluated for depth of anesthesia by monitoring scores of 1-2 on the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale (n=100) or to the BIS-open group and monitored by BIS scores of 60-80"", 'midazolam 2 mg and alfentanil 0.4 mg before undergoing advanced gastrointestinal endoscopy', 'propofol TCI with BIS', 'propofol infusion with or without Bispectral Index monitoring of sedation', 'propofol TCI with or without BIS monitoring']","['Levels of satisfaction', 'sedation-induced adverse events, recovery, and quality of sedation (endoscopist and patient satisfaction', 'Bispectral Index (BIS) technology', 'efficacy and safety', 'total amount of propofol required to maintain anesthesia', 'Mean infusion rates', 'mean propofol infusion rate']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0079278', 'cui_str': 'Endoscopy, Gastrointestinal'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0079278', 'cui_str': 'Endoscopy, Gastrointestinal'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]",200.0,0.0324978,Mean infusion rates were higher in propofol TCI without BIS monitoring compared with propofol TCI with BIS during advanced gastrointestinal endoscopy.,"[{'ForeName': 'Yueh-Juh', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, En Chu Kong Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Hsun', 'Initials': 'HH', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Hsiang', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Min-Xiu', 'Initials': 'MX', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pei-Lin', 'Initials': 'PL', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, Taipei, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14943']
751,31274187,The impact of laparoscopic adrenalectomy on renal function. Results of a prospective randomised clinical trial.,"INTRODUCTION


Laparoscopic adrenalectomy is the gold standard management of benign adrenal masses and isolated metastases to adrenal glands. Two techniques of endoscopic adrenalectomy: lateral transperitoneal approach (LTA) and posterior retroperitoneal approach (PRA) seem to be equally safe and effective. Recent studies suggest advantages of PRA over LTA in terms of lower intensity of postoperative pain, shorter hospital stay, faster recovery, and lower early morbidity. However, PRA involves high insufflation pressure of CO₂ within a limited retroperitoneal space. The aim of our study was to prospectively assess the effect of LTA versus PRA laparoscopic adrenalectomies on renal function.
MATERIAL AND METHODS


We randomly assigned patients referred for unilateral adrenalectomy to either LTA (n = 33) or PRA (n = 44). The inclusion criteria were: hormonal activity and/or tumour diameter > 4 cm and/or suspicion of metastasis to adrenal gland. The exclusion criteria comprised: tumours > 8 cm, results of imaging studies suggesting primary invasive malignancy, and refusal to undergo randomisation. The patients were prospectively followed for a minimum of six months. Serum creatinine, cystatin C, and urinary neutrophil gelatinase-associated lipocalin (NGAL) were measured preoperatively and at postoperative days: 1, 7, and 30.
RESULTS


We found increased concentrations of urinary NGAL at day 1 following laparoscopic adrenalectomy using PRA, as compared to LTA. Patients undergoing right-sided PRA had increased creatinine concentrations, as compared to left-sided PRA. Patients with aldosterone-producing adenoma had decreased preoperative eGFR as compared to subjects with non-functioning incidentaloma. NGAL increased significantly in this group postoperatively. All the disturbances normalised within one month postoperatively.
CONCLUSIONS


Renal function impairment after PRA may result from compression of inferior vena cava by high retroperitoneal pressure during right-sided adrenalectomy. Despite the transient character of the observed abnormalities, we suggest that patients with high risk of acute kidney injury may benefit from an alternative technique of adrenalectomy using LTA.",2019,"We found increased concentrations of urinary NGAL at day 1 following laparoscopic adrenalectomy using PRA, as compared to LTA.","['We randomly assigned patients referred for', 'Patients with aldosterone-producing adenoma', 'n=33) or PRA (n=44', 'patients with high risk of acute kidney injury']","['laparoscopic adrenalectomy', 'Laparoscopic adrenalectomy', 'unilateral adrenalectomy to either LTA', 'LTA versus PRA laparoscopic adrenalectomies', 'PRA', 'endoscopic adrenalectomy: lateral transperitoneal approach (LTA) and posterior retroperitonel approach (PRA']","['concentrations of urinary NGAL', 'postoperative pain, shorter hospital stay, faster recovery and lower early morbidity', 'hormonal activity and/or tumor diameter > 4 cm and/or suspicion of metastasis to adrenal gland', 'preoperative eGFR', 'NGAL', 'renal function', 'creatinine concentrations', 'Serum creatinine, cystatin C and urinary neutrophil gelatinase-associated lipocalin (NGAL']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0009777', 'cui_str': ""Conn's Disease""}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]","[{'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1149475', 'cui_str': 'Hormonal activity'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0153691', 'cui_str': 'Secondary malignant neoplasm of adrenal gland (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}]",,0.0960687,"We found increased concentrations of urinary NGAL at day 1 following laparoscopic adrenalectomy using PRA, as compared to LTA.","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kozłowski', 'Affiliation': '1st Department of General and Endocrinological Surgery, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Rydzewska-Rosolowska', 'Affiliation': '2nd Department of Nephrology and Hypertension, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Myśliwiec', 'Affiliation': 'Department of Nuclear Medicine, Medical University of Bialystok, Bialystok, Poland, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Choromańska', 'Affiliation': '1st Department of General and Endocrinological Surgery, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wojskowicz', 'Affiliation': '1st Department of General and Endocrinological Surgery, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Dadan', 'Affiliation': '1st Department of General and Endocrinological Surgery, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Łukaszewicz-Zając', 'Affiliation': 'Department of Biochemical Diagnostics, Medical University of Bialystok, Bialystok, Poland, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mroczko', 'Affiliation': 'Department of Biochemical Diagnostics, Medical University of Bialystok, Bialystok, Poland, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Myśliwiec', 'Affiliation': '1st Department of General and Endocrinological Surgery, Medical University of Bialystok, Bialystok, Poland. piotr.a.mysliwiec@gmail.com.'}]",Endokrynologia Polska,['10.5603/EP.a2019.0029']
752,31837906,"Does intramuscular ondansetron have an effect on intramuscular ketamine-associated vomiting in children? A prospective, randomized, double blind, controlled study.","OBJECTIVE


This study was conducted to determine the effect of intramuscular ondansetron on ketamine-associated vomiting in children undergoing procedural sedation.
METHODS


This randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted at the emergency departments of two university-affiliated tertiary care hospitals. Eligible participants included all 6-month to 16-year-old children who received IM ketamine for PSA in the ED. A convenience sampling approach was used and a block randomization method was applied (blocks of four) using a computer-generated random sequence. Patients received ketamine 4 mg/kg or ketamine 4 mg/kg plus ondansetron 0.1 mg/kg intramuscularly. All findings including the occurrence of vomiting and its frequency were then recorded in the data collection sheets.
RESULTS


Of 56 patients who received ondansetron plus ketamin, 7 (12.5%) and 1 (1.8%) experienced vomiting during recovery and before discharge and Of 65 patients in the control group, 14 (21.5%) and 6 (9.2%) experienced vomiting during recovery and before discharge, respectively. The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
CONCLUSION


Intramuscular ondansetron is effective in controlling ketamine-associated vomiting.",2020,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","['children undergoing procedural sedation', 'emergency departments of two university-affiliated tertiary care hospitals', 'Eligible participants included all 6-month to 16-year-old children who received']","['placebo', 'ketamine', 'IM ketamine', 'Intramuscular ondansetron', 'ketamine 4\u202fmg/kg or ketamine 4\u202fmg/kg plus ondansetron 0.1\u202fmg/kg intramuscularly', 'ondansetron', 'ondansetron plus ketamin']","['vomiting', 'occurrence of vomiting and its frequency', 'rates of vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",65.0,0.545507,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively).
","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: anejati@tumsac.ir.'}, {'ForeName': 'Seyyedhossein Seyyedhoseini', 'Initials': 'SS', 'LastName': 'Davarani', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Talebian', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mtalebian@tums.ac.ir.'}, {'ForeName': 'Firouzi', 'Initials': 'F', 'LastName': 'Hossein', 'Affiliation': 'Department of Paediatrics, Ramsar Campus, Mazandaran University of Medical Science, Mazandaran, Iran. Electronic address: firoozihosein@mazums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: H-akbari@sina.tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158445']
753,31280343,Pre-meal protein intake alters postprandial plasma metabolome in subjects with metabolic syndrome.,"PURPOSE


We examined the effect on the postprandial plasma metabolome of protein pre-meals before a fat-rich main meal.
METHODS


Two randomized, cross-over meal studies were conducted to test the dose-response effect (0 g, 10 g, 20 g) of a pre-meal with whey protein (WP) (PREMEAL I), and the effect of protein quality (10 g WP, casein, or gluten) and timing (- 15 min vs - 30 min) of the pre-meal (PREMEAL II). Participants with metabolic syndrome received one of the test meals on each test day, - 15 min (or - 30 min) prior to a standardized fat-rich breakfast. Plasma samples were collected at - 15 min (or - 30 min), 0, 120, 240 a nd 360 min and analyzed using liquid chromatography-mass spectrometry with an untargeted method.
RESULTS


Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal. Early (- 15 to 0 min) aromatic amino acids and BCAA in response to pre-meal WP partially predict the glucose and insulin response after the main meal. A pre-meal with WP altered the postprandial plasma metabolic pattern of acyl-carnitines, specific PCs, LPCs and LPEs, betaine, citric acid, linoleic acid, and β-hydroxypalmitic acid compared to no pre-meal. The casein and WP pre-meals exhibited similar postprandial amino acid responses whereas a pre-meal with gluten resulted in lower levels of plasma amino acids and its metabolites.
CONCLUSION


A pre-meal with protein affects the postprandial metabolic pattern indicating facilitated glucose and lipid disposal from plasma in participants with metabolic syndrome.",2020,"Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal.","['subjects with metabolic syndrome', 'participants with metabolic syndrome', 'Participants with metabolic syndrome']","['Pre-meal protein intake', 'pre-meal with whey protein (WP']","['postprandial amino acid responses', 'plasma amino acids and its metabolites', 'Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels', 'glucose and insulin response', 'postprandial plasma metabolic pattern of acyl-carnitines, specific PCs, LPCs and LPEs, betaine, citric acid, linoleic acid, and β-hydroxypalmitic acid', 'postprandial metabolic pattern indicating facilitated glucose and lipid disposal from plasma']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0301713', 'cui_str': 'Aromatic Amino Acids'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",,0.0271201,"Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal.","[{'ForeName': 'Ceyda Tugba', 'Initials': 'CT', 'LastName': 'Pekmez', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark. ctp@nexs.ku.dk.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bjørnshave', 'Affiliation': 'Department Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pratico', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958, Frederiksberg C, Denmark.'}]",European journal of nutrition,['10.1007/s00394-019-02039-9']
754,31272334,Use of an Educational Video to Reduce Barriers to Military Mental Health Care.,"OBJECTIVE


Although there is significant need for mental health care among service members, stigma surrounding these services, along with myths associated with behavioral health treatment, discourages care seeking. This study evaluated the effect of a video designed to demystify mental health treatment on barriers to seeking care among military personnel.
METHODS


Participants were 294 active duty U.S. Marine Corps personnel who were randomly assigned to the intervention video only, the intervention video with discussion, or an attentional control video. Participants completed questionnaires that assessed social stigma regarding mental health treatment and willingness to seek help at pretest, posttest, and 6-week follow-up; personal desire for mental health care was assessed at pretest and 6-week follow-up.
RESULTS


Participants who viewed the intervention video in either condition showed significant and similar decreases in social stigma and increases in willingness to seek help at posttest (p<.001), whereas participants in the control group showed no change at posttest in either variable. Although social stigma did not differ by intervention group at the 6-week follow-up, participants in either intervention were 2.56 times more likely than participants in the control group to report a personal desire for mental health care at the 6-week follow-up (p=.05). There were no significant differences between the two interventions on the main outcomes.
CONCLUSIONS


A video in which mental health care providers explain the treatment process may be effective as an initial stand-alone social stigma reduction intervention. Additional efforts are likely needed to sustain effects and to realize increases in help-seeking behavior.",2019,"Although social stigma did not differ by intervention group at the 6-week follow-up, participants in either intervention were 2.56 times more likely than participants in the control group to report a personal desire for mental health care at the 6-week follow-up (p=.05).",['Participants were 294 active duty U.S. Marine Corps personnel who were randomly assigned to the'],"['Educational Video', 'intervention video only, the intervention video with discussion, or an attentional control video', 'video designed to demystify mental health treatment']","['personal desire for mental health care', 'social stigma', 'willingness to seek help']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",294.0,0.0329545,"Although social stigma did not differ by intervention group at the 6-week follow-up, participants in either intervention were 2.56 times more likely than participants in the control group to report a personal desire for mental health care at the 6-week follow-up (p=.05).","[{'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Hurtado', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Simon-Arndt', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Schmied', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Belding', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}, {'ForeName': 'Rosemarie S', 'Initials': 'RS', 'LastName': 'Subala', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Richardson', 'Affiliation': 'Department of Health and Behavioral Sciences, Naval Health Research Center, San Diego (Hurtado, Simon-Arndt, Schmied, Belding, Subala); Leidos, San Diego (Simon-Arndt, Schmied, Belding, Subala); Veterans Administration Medical Center-Dallas, Dallas (Richardson).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800547']
755,31838011,"Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy.
METHODS


This was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m 2 ) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2. Eligible patients were randomly assigned (1:1) to receive either oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). Patients were randomly assigned to interventions by use of a web entry system and the minimisation method with a random component, with sex, dose of cisplatin, and age as factors of allocation adjustment. Patients, medical staff, investigators, and individuals handling data were all masked to treatment assignment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the delayed phase (24-120 h). All randomly assigned patients who satisfied eligibility criteria received a dose of cisplatin 50 mg/m 2  or more, and at least one study treatment, were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at UMIN Clinical Trials Registry, number UMIN000024676.
FINDINGS


Between Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75-83] of 354 patients in the olanzapine group and 231 (66% [61-71] of 351 patients in the placebo group (p<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group.
INTERPRETATION


Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy.
FUNDING


Japan Agency for Medical Research and Development.",2020,One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses.,"['patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with', '≥50 mg/m 2 ) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2', 'Between Feb 9, 2017, and July 13, 2018', '26 hospitals in Japan', '710 patients were enrolled; 356', 'patients undergoing cisplatin-based chemotherapy', 'Eligible patients']","['placebo', 'Olanzapine', 'cisplatin', 'olanzapine', 'oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy', 'Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone', 'cisplatin-based chemotherapy', 'web entry system and the minimisation method with a random component, with sex, dose of cisplatin', 'dexamethasone', 'Olanzapine 5 mg plus standard antiemetic therapy']","['nausea and vomiting', 'grade 3 somnolence', 'complete response', 'grade 3 constipation', 'nausea and vomiting (J-FORCE', 'proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1597589', 'cui_str': 'olanzapine 5 MG [Zyprexa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",710.0,0.286863,One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses.,"[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Gynaecologic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan. Electronic address: ma.abe@scchr.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Gynaecology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Mizutani', 'Affiliation': 'Department of Respiratory Medicine, Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan; Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Hoshina', 'Affiliation': 'Data Management Section, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Takako Yanai', 'Initials': 'TY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Nakashima', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nakao', 'Affiliation': 'Department of Pharmacy, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takei', 'Affiliation': 'Department of Pharmacy, Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Sadamoto', 'Initials': 'S', 'LastName': 'Zenda', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Mizukami', 'Affiliation': 'Department of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Michiru', 'Initials': 'M', 'LastName': 'Sakurai', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30678-3']
756,31838035,Comparative Effectiveness of Sacubitril-Valsartan Versus ACE/ARB Therapy in Heart Failure With Reduced Ejection Fraction.,"OBJECTIVES


This paper aims to compare the effectiveness of sacubitril-valsartan and angiotensin-converting enzyme inhibitor (ACE)/angiotensin receptor blocker (ARB) in systolic heart failure (HF).
BACKGROUND


Sacubitril-valsartan reduced risks of death and hospitalization for HF versus enalapril in ambulatory patients with HF and reduced ejection fraction in the PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor with Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in HF) trial. However, the comparative effectiveness of sacubitril-valsartan and ACE/ARB in patients treated in routine clinical practice is unclear.
METHODS


We identified patients with systolic HF in a U.S. administrative claims database treated with sacubitril-valsartan or ACE/ARB from July 1, 2015, to February 2, 2018. One-to-one propensity score matching was used to balance patients on 29 clinical variables. Cox models were used to compare outcomes between treatment groups.
RESULTS


A total of 7,893 matched pairs were included; mean (SD) follow-up was 6.3 (5.4) months. Sacubitril-valsartan was associated with lower risks of all-cause mortality or all-cause hospitalization (hazard ratio [HR]: 0.86, 95% confidence interval (CI): 0.81 to 0.91; p < 0.001), all-cause mortality (HR: 0.80, 95% CI: 0.66 to 0.97; p = 0.027), and all-cause hospitalization (HR: 0.86, 95% CI: 0.80 to 0.91; p < 0.001), but not HF hospitalization (HR: 1.07, 95% CI: 0.96 to 1.19; p = 0.26). A lower risk of the primary outcome with sacubitril-valsartan was observed in white patients (HR: 0.83, 95% CI: 0.76 to 0.90) but not black patients (21% of population, HR: 1.00, 95% CI: 0.88 to 1.15; interaction p = 0.032). No statistically significant differences in treatment response by sex or age were observed.
CONCLUSIONS


Sacubitril-valsartan was associated with lower risks of death and hospitalization compared with ACE/ARB in a heterogeneous cohort of patients with systolic HF. However, our finding that outcomes with sacubitril-valsartan and ACE/ARBs were similar in black patients warrants further evaluation.",2020,"Sacubitril-valsartan was associated with lower risks of all-cause mortality or all-cause hospitalization (hazard ratio [HR]: 0.86, 95% confidence interval (CI): 0.81 to 0.91; p < 0.001), all-cause mortality (HR: 0.80, 95% CI: 0.66 to 0.97; p = 0.027), and all-cause hospitalization (HR: 0.86, 95% CI: 0.80 to 0.91; p < 0.001), but not HF hospitalization (HR: 1.07, 95% CI: 0.96 to 1.19; p = 0.26).","['A total of 7,893 matched pairs were included; mean (SD) follow-up was 6.3 (5.4) months', 'Heart Failure', 'ambulatory patients with HF and reduced ejection fraction', 'patients with systolic HF in a U.S. administrative claims database treated with']","['sacubitril-valsartan and ACE/ARB', 'sacubitril-valsartan', 'HF versus enalapril', 'ACE/ARB Therapy', 'ACE/ARB', 'sacubitril-valsartan or ACE/ARB', 'sacubitril-valsartan and angiotensin-converting enzyme inhibitor (ACE)/angiotensin receptor blocker (ARB', 'Sacubitril-Valsartan', 'Sacubitril-valsartan']",['lower risks of death and hospitalization'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0371023,"Sacubitril-valsartan was associated with lower risks of all-cause mortality or all-cause hospitalization (hazard ratio [HR]: 0.86, 95% confidence interval (CI): 0.81 to 0.91; p < 0.001), all-cause mortality (HR: 0.80, 95% CI: 0.66 to 0.97; p = 0.027), and all-cause hospitalization (HR: 0.86, 95% CI: 0.80 to 0.91; p < 0.001), but not HF hospitalization (HR: 1.07, 95% CI: 0.96 to 1.19; p = 0.26).","[{'ForeName': 'Nicholas Y', 'Initials': 'NY', 'LastName': 'Tan', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Sangaralingham', 'Affiliation': 'The Robert and Patricia E. Kern Center for the Sciences of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Jeson', 'Initials': 'SJ', 'LastName': 'Sangaralingham', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'The Robert and Patricia E. Kern Center for the Sciences of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota; Division of Health Care Policy and Research in the Department of Health Services Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nilay D', 'Initials': 'ND', 'LastName': 'Shah', 'Affiliation': 'The Robert and Patricia E. Kern Center for the Sciences of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota; Division of Health Care Policy and Research in the Department of Health Services Research, Mayo Clinic, Rochester, Minnesota; OptumLabs, Cambridge, Massachusetts.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; The Robert and Patricia E. Kern Center for the Sciences of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota. Electronic address: dunlay.shannon@mayo.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.003']
757,31369771,Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts.,"BACKGROUND


Despite the availability of different therapeutic modalities, treatment of recalcitrant common warts is still challenging. Cervarix (GlaxoSmithKline, Brentford, UK), a recombinant bivalent human papillomavirus (HPV) vaccine, has shown promising efficacy in the treatment of warts.
OBJECTIVES


To evaluate the beneficial effects and tolerability of intramuscular versus intralesional bivalent HPV vaccine in the treatment of recalcitrant common warts.
METHODS


The study included 44 adult patients with multiple recalcitrant common warts; 22 patients received intramuscular injection of bivalent HPV vaccine at 0, 1, and 6 months or until complete clearance of warts, and the other 22 patients received intralesional injection of 0.1 to 0.3 mL of bivalent HPV vaccine into the largest wart at 2-week intervals until complete clearance or for a maximum of 6 sessions.
RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant. Adverse effects were transient and insignificant, and no recurrence was reported in either group.
LIMITATIONS


Small study sample and different dosing schedules.
CONCLUSIONS


Bivalent HPV vaccine, particularly by intralesional injection, seems to be a potential therapeutic option for the treatment of multiple recalcitrant common warts.",2020,"RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and in 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant.","['44 adult patients with multiple recalcitrant common warts; 22 patients', 'recalcitrant common warts']","['Intralesional versus intramuscular bivalent human papillomavirus vaccine', 'recombinant bivalent human papillomavirus (HPV) vaccine', 'intralesional bivalent HPV vaccine', 'intramuscular bivalent HPV vaccine at 0, 1, and 6 months or until complete clearance of warts and the other 22 patients were intralesionally injected with 0.1 to 0.3 ml of bivalent HPV vaccine']","['Complete clearance of warts', 'Adverse effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.0738268,"RESULTS


Complete clearance of warts was observed in 18 patients (81.8%) of the intralesional group and in 14 patients (63.3%) of the intramuscular group; however, the difference was not statistically significant.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nofal', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt. Electronic address: ahmadnofal5@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Marei', 'Affiliation': 'Microbiology and Immunology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Al-Shimaa M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Nofal', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Nabil', 'Affiliation': 'Dermatology Department, Zagazig University, Zagazig, Egypt.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.070']
758,32409778,A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial.,"STUDY DESIGN


Protocol for a pragmatic randomized controlled trial (the Exercise guideline Promotion and Implementation in Chronic SCI [EPIC-SCI] Trial).
PRIMARY OBJECTIVES


To test if home-/community-based exercise, prescribed according to the international SCI exercise guidelines, significantly reduces chronic bodily pain in adults with SCI.
SECONDARY OBJECTIVES


To investigate: (1) the effects of exercise on musculoskeletal and neuropathic chronic pain; (2) if reduced inflammation and increased descending inhibitory control are viable pathways by which exercise reduces pain; (3) the effects of chronic pain reductions on subjective well-being; and (4) efficiency of a home-/community-based exercise intervention.
SETTING


Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada.
METHOD


Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines, will be recruited and randomized to a 6-month Exercise or Wait-List Control condition. Exercise will occur in home/community settings and will be supported through behavioral counseling. All measures will be taken at baseline, 3-months and 6-months. Analyses will consist of linear mixed effect models, multiple regression analyses and a cost-utility analysis. The economic evaluation will examine the incremental costs and health benefits generated by the intervention compared with usual care.
ETHICS AND DISSEMINATION


The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19-01650). Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.",2020,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","['adults with SCI', 'Exercise in home-/community-based settings; assessments in university-based laboratories in British Columbia, Canada', 'Eighty-four adults with chronic SCI, reporting chronic musculoskeletal or neuropathic pain, and not meeting the current SCI exercise guidelines']","['home-/community-based exercise intervention', 'international scientific SCI exercise guidelines', '6-month Exercise or Wait-List Control condition', 'exercise']","['chronic bodily pain', 'musculoskeletal and neuropathic chronic pain', 'SCI chronic pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",84.0,0.155033,"Using an integrated knowledge translation approach, stakeholders will be engaged throughout the trial and will co-create and disseminate evidence-based recommendations and messages regarding the use of exercise to manage SCI chronic pain.","[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada. kathleen_martin.ginis@ubc.ca.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'van der Scheer', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Centre for Chronic Disease Prevention and Management, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gaudet', 'Affiliation': 'Spinal Cord Injury British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoekstra', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health and Centre for Health Evaluation and Outcome Sciences, Providence Health Care, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John L K', 'Initials': 'JLK', 'LastName': 'Kramer', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, UBC; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Townson', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0478-7']
759,31174172,Variability in triage practices for critically ill cancer patients: A randomized controlled trial.,"PURPOSE


Intensive care triage practices and end-user interpretation of triage guidelines have rarely been assessed. We evaluated agreement between providers on the prioritization of patients for ICU admission using different triage guidelines.
MATERIALS AND METHODS


A multi-centered randomized study on providers from 18 different countries was conducted using clinical vignettes of oncological patients. The level of agreement between providers was measured using two different guidelines, with one being cancer specific.
RESULTS


Amongst 257 providers, 52.5% randomly received the Society of Critical Care Prioritization Model, and 47.5% received a cancer specific flowchart as a guide. In the Prioritization Model arm the average entropy was 1.193, versus 1.153 in the flowchart arm (P = .095) indicating similarly poor agreement. The Fleiss' kappa coefficients were estimated to be 0.2136 for the SCCMPM arm and 0.2457 for the flowchart arm, also similarly implying poor agreement.
CONCLUSIONS


The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients. The lack of consensus on intensive care unit triage practices in the oncological population exposes a potential barrier to appropriate resource allocation that needs to be addressed.",2019,The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients.,"['critically ill cancer patients', 'providers from 18 different countries was conducted using clinical vignettes of oncological patients']",[],"[""Fleiss' kappa coefficients"", 'average entropy']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],"[{'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}]",,0.0951624,The low agreement amongst practitioners on the prioritization of cancer patient cases for ICU admission existed using both general triage guidelines and guidelines tailored only to cancer patients.,"[{'ForeName': 'Nisha K', 'Initials': 'NK', 'LastName': 'Rathi', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: nrathi@mdanderson.org.'}, {'ForeName': 'Sajid A', 'Initials': 'SA', 'LastName': 'Haque', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: shaque@mdanderson.org.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Morales', 'Affiliation': 'Hospital Oncológico ""Dr. Julio Villacreses Colmont"" SOLCA Manabí, Núcleo de Portoviejo, Autopista del Valle Manabí Guillen en Portoviejo, Manibi, Ecuador.'}, {'ForeName': 'Bhavika', 'Initials': 'B', 'LastName': 'Kaul', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: Bhavika.kaul@ucsf.edu.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ramirez', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: rramirezfernand@augusta.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ovu', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: Sto9021@nyp.org.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: leifeng@mdanderson.org.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: wdong@mdanderson.org.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Price', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: kjprice@mdanderson.org.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ugarte', 'Affiliation': ""INDISA Clinic, Salvador's Hospital, Avenida Santa Maria 1810, Providencia Region Metropolitana, Santiago, Chile.""}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Raimondi', 'Affiliation': 'Juan A. Fernandez Hospital, Cervino 3356, C1425AGP CABA, Buenos Aires, Argentina.'}, {'ForeName': 'Agamenon', 'Initials': 'A', 'LastName': 'Quintero', 'Affiliation': 'Imatoncomedica S.A., Carrera 6A #72-34, Monteria, Cordoba, Colombia.'}, {'ForeName': 'Yenny R', 'Initials': 'YR', 'LastName': 'Cardenas', 'Affiliation': 'Critical Care Department, Universidad del Rosario, Hospital Universitario Fundacion Santa Fe de Bogota, Carrera 7 No. 117 - 15, Bogota DC, Colombia.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Nates', 'Affiliation': 'Department of Critical Care, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 112, Houston, TX 77030, United States of America. Electronic address: jlnates@mdanderson.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2019.05.012']
760,31256911,Mobility after intertrochanteric hip fracture fixation with either a sliding hip screw or a cephalomedullary nail: Sub group analysis of a randomised trial of 1000 patients.,"AIMS


The aim of this study was to determine if different patient groups have superior mobility regain following intertrochanteric hip fracture fixation with a cephomedullary nail compared to a sliding hip screw (SHS).
PATIENTS AND METHODS


The present study is a subgroup analysis of patients which were enrolled into a randomized controlled trial which randomized 1000 patients with an intertrochanteric hip fracture to fixation with either a short cephomedullary nail (Targon® PF or PFT) or a SHS. In the present study the two treatment groups were dicotomised on the basis of six variables determined at the time of admission; age (<80; ≥80 years), sex, residence (admitted from own home; institutional care), mobility (mobility score ≥7 [good]; <7 [poor]), mental status (AMTS < 7 [cognitively impaired]; ≥7) and health status (ASA < 3; ≥3). The primary outcome measure was the difference between mobility score pre-fracture and mobility score during the year after hip fracture fixation.
RESULTS


Patients less than 80 years of age, those admitted from their own home, cognitively intact patients and patients who mobilised without assistance pre-fracture, recovered superior mobility when fracture fixation was performed with a nail compared to a SHS. Those patients admitted from institutional care, those with significant cognitive or mobility impairment at the time of the injury did not have any significantly improved benefit in mobility regain with a nail compared to a SHS.
CONCLUSION


Fixation of an intertrochanteric hip fracture with a cephomedullary nail results in superior recovery of mobility for younger patients who prior to the injury were more mobile, cognitively intact and living at home.",2019,"CONCLUSION


Fixation of an intertrochanteric hip fracture with a cephomedullary nail results in superior recovery of mobility for younger patients who prior to the injury were more mobile, cognitively intact and living at home.","['1000 patients with an', 'younger patients who prior to the injury were more mobile, cognitively intact and living at home', 'Patients less than 80 years of age, those admitted from their own home, cognitively intact patients and patients who mobilised without assistance pre-fracture', 'admission; age (<80; ≥80 years), sex, residence (admitted from own home; institutional care), mobility (mobility score ≥7 [good]; <7 [poor]), mental status (AMTS\u202f<\u202f7 [cognitively impaired]; ≥7) and health status (ASA\u202f<\u202f3; ≥3', '1000 patients']","['sliding hip screw', 'intertrochanteric hip fracture to fixation with either a short cephomedullary nail (Targon® PF or PFT) or a SHS', 'intertrochanteric hip fracture fixation with a cephomedullary nail compared to a sliding hip screw (SHS', 'Fixation']","['Mobility', 'mobility regain', 'mobility score pre-fracture and mobility score']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]","[{'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",1000.0,0.0661403,"CONCLUSION


Fixation of an intertrochanteric hip fracture with a cephomedullary nail results in superior recovery of mobility for younger patients who prior to the injury were more mobile, cognitively intact and living at home.","[{'ForeName': 'Joshua C Y', 'Initials': 'JCY', 'LastName': 'Ong', 'Affiliation': 'Department of Orthopaedics, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, Bretton Gate, Peterborough, Cambridgeshire, PE3 9GZ, England, United Kingdom. Electronic address: joshua.ong@nhs.net.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Gill', 'Affiliation': 'Department of Orthopaedics, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, Bretton Gate, Peterborough, Cambridgeshire, PE3 9GZ, England, United Kingdom.'}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Parker', 'Affiliation': 'Department of Orthopaedics, Peterborough and Stamford Hospital NHS Foundation Trust, Peterborough City Hospital, Bretton Gate, Peterborough, Cambridgeshire, PE3 9GZ, England, United Kingdom.'}]",Injury,['10.1016/j.injury.2019.06.015']
761,31249394,Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.,"BACKGROUND


Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection.
METHODS


To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed.
RESULTS


Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R 2 : 0.75; P < 2 × 10 -16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients.
CONCLUSION


Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience.
CLINICAL TRIAL REGISTRATION


NCT01761266.",2019,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.",['hepatocellular carcinoma'],['lenvatinib vs sorafenib'],['UPCR and 24-hour urine protein'],"[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}]",,0.0399609,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.","[{'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Severance Hospital, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Silvija', 'Initials': 'S', 'LastName': 'Kraljevic', 'Affiliation': 'Former employee of Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Unit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Max W', 'Initials': 'MW', 'LastName': 'Sung', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-019-0506-6']
762,31268194,Individualized Human Milk Fortification to Improve the Growth of Hospitalized Preterm Infants.,"BACKGROUND


Human milk (HM) is the first choice for preterm infants, but exclusive HM feeding is inadequate for the growth of very preterm infants. The hypothesis of this trial is that infants fed according to an individualized fortification regimen will have higher protein intake and improved weight gain velocity (WGV).
METHODS


A prospective, randomized, controlled study was conducted. Infants <34 weeks of gestational age were enrolled when enteral feeding volume reached 60 mL/kg/d and were randomly allocated to the individualized fortification (IF) group or the standard fortification group. The IF group was fed using a regimen that featured modifying HM fortifier and supplemental protein powder based on the protein concentration in HM, current body weight of infants, and blood urea nitrogen (fortification level was set as L-1, L0, L1, L2, L3; the amount of HM fortifier and protein powder were determined accordingly).
RESULTS


Between September 2012 and August 2016, 51 preterm infants completed the study. In the IF group, 62.5% (15/24) of preterm infants were fed with HM fortified to level 1, 29.2% (7/24) to level 2, and 12.5% (3/24) to level 3. The WGV of the third week in the IF group was greater than the standard group (20.8 ± 7.9 vs 14.9 ± 4.5 g/kg/d, P = 0.022).
CONCLUSION


About two-thirds of preterm infants needed to adjust the HM fortification to a higher level. The WGV of infants in the IF group was better than that of the standard group in the third week of this study.",2020,The WGV of infants in the IF group was better than that of the standard group in the third week of this study.,"['Between September 2012 and August 2016', 'Infants <34 weeks of gestational age', 'Hospitalized Preterm Infants', 'preterm infants', '51 preterm infants completed the study']","['individualized fortification (IF) group or the standard fortification group', 'Individualized Human Milk Fortification', 'enteral feeding volume']",['weight gain velocity (WGV'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",51.0,0.0432777,The WGV of infants in the IF group was better than that of the standard group in the third week of this study.,"[{'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Quan', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Gou', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingran', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lejia', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schibler', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10366']
763,31258054,"Acute effects of kinesio taping on muscular strength and endurance parameters of the finger flexors in sport climbing: A randomised, controlled crossover trial.","Kinesio taping (KT) is a commonly used intervention in sports and, recently, KT has become popular among athletes competing in sport climbing and bouldering events. However, evidence on the effect of KT on grip strength and endurance is still controversial. Therefore, the purpose of this study was to evaluate immediate effects of KT on muscular strength and endurance of the finger flexor muscles in sport climbers. Twenty recreationally-trained active sport climbers (10 men, 10 women) aged 28.5 ± 10.6 years performed one familiarisation trial and subsequently, in a randomised crossover design, two test trials either with (TAPE) or without (CONTROL) KT over the finger flexor muscles. Test trials consisted of three performance measurements (hand grip strength and endurance, finger hang, and lap climbing) at intervals of 48 h in a randomised order. We observed no significant differences in the parameters of hand grip peak force, fatigue index, finger hang time, lap climbing distance and time, or maximum blood lactate values after lap climbing between the TAPE and CONTROL trials ( p  > 0.05). The participants' climbing ability was significantly correlated with the intra-individual performance changes between the TAPE and CONTROL conditions for the fatigue index ( r  = -0.598,  p  = 0.005), but not in any of the other performance-related parameters. Therefore, KT over the finger flexor muscles neither enhanced hand grip strength and endurance nor the sport climbing performance parameters of finger hang, lap climbing distance and time, and maximum blood lactate values after lap climbing.",2020,"We observed no significant differences in the parameters of hand grip peak force, fatigue index, finger hang time, lap climbing distance and time, or maximum blood lactate values after lap climbing between the TAPE and CONTROL trials ( p  > 0.05).","['sport climbers', 'Twenty recreationally-trained active sport climbers (10 men, 10 women) aged 28.5\u2009±\u200910.6 years performed one familiarisation trial and subsequently', 'sport climbing']","['kinesio taping', 'three performance measurements (hand grip strength and endurance, finger hang, and lap climbing', 'KT', 'Kinesio taping (KT', 'TAPE) or without (CONTROL) KT']","['muscular strength and endurance parameters', 'grip strength and endurance nor the sport climbing performance parameters of finger hang, lap climbing distance and time, and maximum blood lactate values', 'parameters of hand grip peak force, fatigue index, finger hang time, lap climbing distance and time, or maximum blood lactate values', 'muscular strength and endurance of the finger flexor muscles', 'climbing ability']","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0297138,"We observed no significant differences in the parameters of hand grip peak force, fatigue index, finger hang time, lap climbing distance and time, or maximum blood lactate values after lap climbing between the TAPE and CONTROL trials ( p  > 0.05).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Limmer', 'Affiliation': 'Institute of Outdoor Sports and Environmental Science, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Buck', 'Affiliation': 'Institute of Outdoor Sports and Environmental Science, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'de Marées', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Institute of Outdoor Sports and Environmental Science, German Sport University Cologne, Cologne, Germany.'}]",European journal of sport science,['10.1080/17461391.2019.1633415']
764,31801787,Sex Difference in Effects of Low-Dose Aspirin on Prevention of Dementia in Patients With Type 2 Diabetes: A Long-term Follow-up Study of a Randomized Clinical Trial.,"OBJECTIVE


To evaluate and compare the efficacy of long-term use of low-dose aspirin for the prevention of dementia in men and women.
RESEARCH DESIGN AND METHODS


This study is a follow-up cohort study of the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) trial, which was a randomized, open-label, standard care-controlled trial examining the effects of low-dose aspirin on cardiovascular events. We followed up 2,536 Japanese patients with type 2 diabetes (T2D) enrolled in the JPAD trial from 2002 to 2017. The primary outcome of this post hoc analysis was the incidence of dementia, which was defined by the prescription of antidementia drugs or admission due to dementia.
RESULTS


Among the originally enrolled patients, 2,121 (84%) retained their original allocation. During a median follow-up of 11.4 years, 128 patients developed dementia. The overall effect of low-dose aspirin on the prevention of dementia adjusted for age, sex, and other established risk factors was not significant (hazard ratio [HR] 0.82, 95% CI 0.58-1.16). However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
CONCLUSIONS


Long-term use of low-dose aspirin may reduce the risk for dementia in women with T2D.",2020,"However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
","['128 patients developed dementia', '2,536 Japanese patients with type 2 diabetes (T2D) enrolled in the JPAD trial from 2002 to 2017', 'Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD', 'dementia in men and women', 'Patients With Type 2 Diabetes', 'women with T2D']","['Low-Dose Aspirin', 'aspirin', 'low-dose aspirin']","['incidence of dementia, which was defined by the prescription of antidementia drugs or admission due to dementia', 'risk of dementia', 'cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C1276997', 'cui_str': 'Antidementia drug'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",128.0,0.195719,"However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) ( P   interaction  = 0.03).
","[{'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Kumamoto, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Diabetes Care Center, Jinnouchi Hospital, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Department of Internal Medicine, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan morimoto@kuhp.kyoto-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1188']
765,31801872,"Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.","OBJECTIVE


This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.
DESIGN


Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.
RESULTS


Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.
CONCLUSION


TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials.
TRIAL REGISTRATION NUMBER


NCT01217034.",2020,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","['patients with unresectable HCC', 'patients with hepatocellular carcinoma', 'Patients with unresectable hepatocellular carcinoma (HCC']","['transarterial chemoembolisation (TACE) plus sorafenib', 'sorafenib 400\u2009mg once daily for 2-3 weeks before TACE, followed by 800\u2009mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP', 'transarterial chemoembolisation (TACE) plus sorafenib with TACE', 'TACE', 'Median TTUP', 'TACE alone', 'TACE plus sorafenib']","['toxicities', 'TTUP, or time to any cause of death plus overall survival (OS', 'progression-free survival (PFS', 'efficacy and safety', 'Adverse events', 'PFS', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0496813,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan m-kudo@med.kindai.ac.jp.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Gastroenterology, National Hospital Organisation Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aikata', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube-Yamaguchi, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hino', 'Affiliation': 'Department of Hepatology and Pancreatology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Tsumura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Teiji', 'Initials': 'T', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Isoda', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kohichiroh', 'Initials': 'K', 'LastName': 'Yasui', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Aino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Social Insurance Tagawa Hospital, Tagawa, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ido', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kawabe', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokosuka', 'Affiliation': 'Department of Gastroenterology, School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': 'Department of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Okita', 'Affiliation': 'Deapartment of Medicine, Shunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.'}, {'ForeName': 'Philip James', 'Initials': 'PJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2019-318934']
766,31246894,Efficacy of a new single-pill combination of a thiazide-like diuretic and a calcium channel blocker (indapamide sustained release/amlodipine) in essential hypertension.,"OBJECTIVES


The current international, 12-week, double-blind, randomized, controlled trial assessed the efficacy and safety of indapamide sustained release/amlodipine single-pill combination (SPC) in mild-to-moderate hypertensive patients.
METHODS


Following a 4-week run-in period on amlodipine 5 mg, patients (SBP 150-180 mmHg and/or DBP < 110 mmHg) were randomized to indapamide 1.5 mg sustained release/amlodipine 5 mg SPC or amlodipine 5 mg/valsartan 80 mg SPC with conditional uptitration at week 6. Office blood pressure (BP) was assessed at baseline, weeks 6 and 12; ambulatory and home blood pressure monitoring (ABPM/HBPM) at baseline and week 12.
RESULTS


Baseline characteristics were similar in both groups (57 years, 51% men, BP 160/92 mmHg). 233 patients were randomized to IndSR/Aml and 232 to amlodipine/valsartan, of whom 48 and 57% were uptitrated, respectively. After 12 weeks, office SBP/DBP decreased similarly with both treatments (-21/-8 vs. -20/-8 mmHg) leading to BP control in 50% and BP response in 70% of patients. Uptitration was effective (P < 0.001) with both regimens, in favour of IndSR/Aml (SBP/DBP -12/-6 vs. -7/-3 mmHg, respectively). ABPM (n = 273) and HBPM (n = 194) confirmed 24-h efficacy of both regimens. In the subgroup of patients with sustained uncontrolled hypertension assessed by ABPM (n = 216), office SBP/DBP decreased by -23/-13 vs. -18/-10 mmHg, respectively (P = 0.016/P = 0.135, post-hoc analysis). Both treatments were generally well tolerated.
CONCLUSION


Both regimens produced effective BP reductions confirmed by ABPM/HBPM. Both treatments were well tolerated, in accordance with the individual agents' safety profile.
TRIAL REGISTRATION NUMBER


EUDRA CT no. 2012-001690-84.",2019,"Uptitration was effective (P < 0.001) with both regimens, in favour of IndSR/Aml (SBP/DBP -12/-6 vs. -7/-3 mmHg, respectively).","['essential hypertension', '5\u200amg, patients (SBP 150-180\u200ammHg and/or DBP\u200a<\u200a110\u200ammHg', '233 patients', 'mild-to-moderate hypertensive patients']","['ABPM', 'thiazide-like diuretic and a calcium channel blocker (indapamide sustained release/amlodipine', 'amlodipine single-pill combination (SPC', 'amlodipine/valsartan', 'indapamide 1.5\u200amg sustained release/amlodipine 5\u200amg SPC or amlodipine 5', 'HBPM', 'indapamide', 'valsartan', 'amlodipine']","['Office blood pressure (BP', 'tolerated', 'blood pressure monitoring (ABPM/HBPM', 'office SBP/DBP', 'efficacy and safety', 'BP response', 'effective BP reductions']","[{'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C1962523', 'cui_str': 'Amlodipine / valsartan'}, {'cui': 'C1131881', 'cui_str': 'Indapamide 1.5 MG'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1606917', 'cui_str': 'Amlodipine 5 MG [Norvasc]'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",233.0,0.125734,"Uptitration was effective (P < 0.001) with both regimens, in favour of IndSR/Aml (SBP/DBP -12/-6 vs. -7/-3 mmHg, respectively).","[{'ForeName': 'Anna F', 'Initials': 'AF', 'LastName': 'Dominiczak', 'Affiliation': 'Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'de Champvallins', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Romualda', 'Initials': 'R', 'LastName': 'Brzozowska-Villatte', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Asmar', 'Affiliation': 'Foundation-Medical Research Institutes, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002177']
767,31120381,"Awareness of ocular diagnosis, transportation means, and barriers to ophthalmology follow-up in the Philadelphia Telemedicine Glaucoma Detection and Follow-up Study.","Purpose : The purpose of this study was to assess factors affecting follow-up eye care in participants enrolled in the  Philadelphia Telemedicine Glaucoma Detection and Follow-up Study , such as awareness of ocular diagnosis, availability of transportation methods, and reasons for missing eye care appointments.  Methods : The sample included 172 participants who were randomized to the intervention group and contacted by the social worker.  Results : A total of 155 participants completed the assessment form, which was used as an instrument to assess factors affecting adherence to follow-up eye care. The main reasons for missing eye exam appointments were feeling ill (38.1%, n = 59) and forgetting the appointment (34.2%, n = 53). In addition, 45 (29.2%) participants were unaware of or did not comprehend the severity of their ocular diagnosis. Common methods of transportation included public transportation (31.6%, n = 49), driving (29.7%, n = 46), and being driven (27.7%, n = 43) to their appointment.  Conclusion : These results suggest that individuals in need of eye care may benefit from additional assistance of a social worker regarding ongoing eye exam appointment reminders and in-depth explanation of their ocular diagnosis.",2019,"A total of 155 participants completed the assessment form, which was used as an instrument to assess factors affecting adherence to follow-up eye care.","['172 participants who were randomized to the intervention group and contacted by the social worker', 'participants enrolled in the  Philadelphia Telemedicine Glaucoma Detection and Follow-up Study , such as awareness of ocular diagnosis, availability of transportation methods, and reasons for missing eye care appointments', '155 participants']",[],[],"[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],[],172.0,0.0775417,"A total of 155 participants completed the assessment form, which was used as an instrument to assess factors affecting adherence to follow-up eye care.","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Hark', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Anjithaa', 'Initials': 'A', 'LastName': 'Radakrishnan', 'Affiliation': 'c Sidney Kimmel Medical College, Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Malika', 'Initials': 'M', 'LastName': 'Madhava', 'Affiliation': 'c Sidney Kimmel Medical College, Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Anderson-Quiñones', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Fudemberg', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Myers', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhan', 'Affiliation': 'd Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics , Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Adeghate', 'Affiliation': 'e Department of Ophthalmology , Weill Cornell Medical College , New York , NY , USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hegarty', 'Affiliation': 'd Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics , Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Stela', 'Initials': 'S', 'LastName': 'Leite', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Leiby', 'Affiliation': 'd Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics , Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Stempel', 'Affiliation': 'b Department of Ophthalmology , Columbia University Irving Medical Center , New York , NY , USA.'}, {'ForeName': 'L Jay', 'Initials': 'LJ', 'LastName': 'Katz', 'Affiliation': 'a Wills Eye Hospital, Glaucoma Research Center , Philadelphia , PA , USA.'}]",Social work in health care,['10.1080/00981389.2019.1614711']
768,31238312,"Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients.","BACKGROUND


Pancreatic stones are pathognomonic of chronic pancreatitis (CP). This study aimed to determine the incidence, identify risk factors, and develop a nomogram for pancreatic stones in CP patients.
METHODS


Patients with CP admitted to our center from January 2000 to December 2013 were enrolled. Cumulative rates of pancreatic stones after the onset of CP and after the diagnosis of CP were calculated. Patients were randomly assigned, in a 2:1 ratio, to the training and validation cohort. Based on the training cohort, risk factors were identified through Cox proportional hazards regression model, and nomogram was developed. Internal and external validations were performed based on the training and validation cohort, respectively.
RESULTS


With a total of 2,153 CP patients, pancreatic stones were detected in 1,626 (75.5%) patients, with a median follow-up of 7.8 years. Age at the onset of CP, body mass index, smoking, diabetes mellitus, pancreatic pseudocyst, biliary stricture, severe acute pancreatitis, and type of pain were identified risk factors for pancreatic stones development. The nomogram with these 8 factors achieved good accuracy.
CONCLUSIONS


The nomogram achieved an individualized prediction of pancreatic stones development in CP. It may help the management of pancreatic stones.",2020,The nomogram achieved an individualized prediction of pancreatic stones development in CP.,"['CP patients', 'Patients with CP admitted to our center from January 2000 to December 2013 were enrolled', '2,153 Patients']",[],"['pancreatic stones', 'Cumulative rates of pancreatic stones']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0440736', 'cui_str': 'Pancreatic stone (substance)'}]",2153.0,0.0190087,The nomogram achieved an individualized prediction of pancreatic stones development in CP.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hong-Lei', 'Initials': 'HL', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Bi', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun-Tao', 'Initials': 'JT', 'LastName': 'Ji', 'Affiliation': 'Endoscopy Center, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Du', 'Affiliation': 'Endoscopy Center, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jin-Huan', 'Initials': 'JH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiang-Peng', 'Initials': 'XP', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zou', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bai-Rong', 'Initials': 'BR', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Air Force General Hospital, Beijing, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Cong', 'Affiliation': 'Department of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China, lianghao-hu@hotmail.com.'}]",Digestion,['10.1159/000500941']
769,31799940,Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial.,"BACKGROUND


Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making.
OBJECTIVE


The objective of this study was to develop a literacy-sensitive Web-based patient decision aid based on the Ottawa decision support framework, and through a randomized clinical trial estimate the effectiveness of the patient decision aid in improving patient knowledge and their involvement in decision making.
METHODS


We conducted population decisional needs assessments in a nationwide sample of patients, caregivers, community advocates, policy makers, and health care providers using qualitative interviews to identify decisional conflict, knowledge and expectations, values, support and resources, decision types, timing, stages and learning, and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Alpha testing of the patient decision aid prototype was done to establish usability and the accuracy of the information it conveyed, and then was followed by iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the patient decision aid.
RESULTS


In a decisional needs assessment, 223 stakeholders described their preferences, helping to guide the development of the patient decision aid, which then underwent alpha testing by 30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders. In a randomized clinical trial, 120 participants were assigned to either the patient decision aid or standard care (SC) arm. Qualitative interviews revealed high levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making. On the acceptability survey, 72% (86/120) of participants rated the patient decision aid as good or excellent. Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months. However, there was no improvement in terms of the change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies at 6 months. The large amount of missing data from survey completion limited our ability to draw conclusions about the effectiveness of the patient decision aid. The patient decision aid met 61 of 62 benchmarks of the international patient decision aid collaboration standards for content, development process, and efficacy.
CONCLUSIONS


We have developed a patient decision aid for sickle cell disease with extensive input from stakeholders and in a randomized clinical trial demonstrated its acceptability and utility in education and decision making. We were unable to demonstrate its effectiveness in improving patient knowledge and involvement in decision making.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597.",2019,"Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months.","['120 participants', 'Sickle Cell Disease', '30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders', 'adults and of caregivers of pediatric patients']","['Web-Based Patient Decision Aid', 'patient decision aid or standard care (SC']","['levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making', 'informed sub-score of decisional conflict', 'decisional self-efficacy', 'change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",223.0,0.202862,"Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months.","[{'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Leong', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Nonita', 'Initials': 'N', 'LastName': 'Mittal', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Veludhandi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Anh-Phuong', 'Initials': 'AP', 'LastName': 'Pham', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Alankrita', 'Initials': 'A', 'LastName': 'Taneja', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Kamesh', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Julum', 'Initials': 'J', 'LastName': 'Nwanze', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Andrea Marie', 'Initials': 'AM', 'LastName': 'Matthews', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Vazquez Olivieri', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Santhi', 'Initials': 'S', 'LastName': 'Arjunan', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Ifechi', 'Initials': 'I', 'LastName': 'Okonkwo', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Lukombo', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lane', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States.""}]",Journal of medical Internet research,['10.2196/14462']
770,31796571,Glucose and Counterregulatory Responses to Exercise in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia Using Closed-Loop Insulin Delivery: A Randomized Crossover Study.,"OBJECTIVE


To evaluate exercise-related glucose and counterregulatory responses (CRR) in adults with type 1 diabetes with impaired awareness of hypoglycemia (IAH) using hybrid closed-loop (HCL) insulin delivery to maintain glucose homeostasis.
RESEARCH DESIGN AND METHODS


Twelve participants undertook 45-min high-intensity intermittent exercise (HIIE) and moderate-intensity exercise (MIE) in random order. The primary outcome was continuous glucose monitoring (CGM) time in range (70-180 mg/dL) for 24-h post-exercise commencement.
RESULTS


CGM time in range was similar for HIIE and MIE (median 79.5% [interquartile range 73.2, 87.6] vs. 76.1% [70.3, 83.9],  P  = 0.37), and time with levels <54mg/dL post-exercise commencement was 0%. HIIE induced greater increases in cortisol ( P  = 0.002), noradrenaline ( P  = 0.005), and lactate ( P  = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
CONCLUSIONS


IAH adults using HCL undertaking HIIE and MIE exhibit heterogeneity in CRR. Novel findings were a preserved cortisol response and variable catecholamine responses to HIIE.",2020,"HIIE induced greater increases in cortisol ( P  = 0.002), noradrenaline ( P  = 0.005), and lactate ( P  = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
","['Twelve participants undertook 45-min high', 'Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia', 'adults with type 1 diabetes with impaired awareness of hypoglycemia (IAH']","['hybrid closed-loop (HCL) insulin delivery', 'intensity intermittent exercise (HIIE) and moderate-intensity exercise (MIE', 'exercise-related glucose and counterregulatory responses (CRR', 'Closed-Loop Insulin Delivery']","['Glucose and Counterregulatory Responses', 'adrenaline, dopamine, growth hormone, or glucagon responses', 'cortisol', 'continuous glucose monitoring (CGM) time', 'noradrenaline']","[{'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]",12.0,0.0828513,"HIIE induced greater increases in cortisol ( P  = 0.002), noradrenaline ( P  = 0.005), and lactate ( P  = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
","[{'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vogrin', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Paldus', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Dilshani', 'Initials': 'D', 'LastName': 'Jayawardene', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Jones', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Sybil A', 'Initials': 'SA', 'LastName': 'McAuley', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Varuni', 'Initials': 'V', 'LastName': 'Obeyesekere', 'Affiliation': ""Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gooley', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': ""Department of Cardiology, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Sundararajan', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Ward', 'Affiliation': ""Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': ""O'Neal"", 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia dno@unimelb.edu.au.'}]",Diabetes care,['10.2337/dc19-1433']
771,31551368,Potent reduction of plasma lipoprotein (a) with an antisense oligonucleotide in human subjects does not affect ex vivo fibrinolysis.,"It is postulated that lipoprotein (a) [Lp(a)] inhibits fibrinolysis, but this hypothesis has not been tested in humans due to the lack of specific Lp(a) lowering agents. Patients with elevated Lp(a) were randomized to antisense oligonucleotide [IONIS-APO(a) Rx ] directed to apo(a) ( n  = 7) or placebo ( n  = 10). Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, plasminogen activator inhibitor 1, thrombin activatable fibrinolysis inhibitor, and fibrinogen at baseline, day 85/92/99 (peak drug effect), and day 190 (3 months off drug) were measured. The mean ± SD baseline Lp(a) levels were 477.3 ± 55.9 nmol/l in IONIS-APO(a) Rx  and 362.1 ± 89.9 nmol/l in placebo. The mean± SD percentage change in Lp(a) for IONIS-APO(a) Rx  was -69.3 ± 12.2% versus -5.4 ± 6.9% placebo ( P  < 0.0010) at day 85/92/99 and -15.6 ± 8.9% versus 3.2 ± 12.2% ( P  = 0.003) at day 190. Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a) Rx  and placebo at all time points. Clot lysis times were not affected by exogenously added Lp(a) at concentrations up to 200 nmol/l to plasma with very low (12.5 nmol/l) Lp(a) levels, whereas recombinant apo(a) had a potent antifibrinolytic effect. In conclusion, potent reductions of Lp(a) in patients with highly elevated Lp(a) levels do not affect ex vivo measures of fibrinolysis; the relevance of any putative antifibrinolytic effects of Lp(a) in vivo needs further study.",2019,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"['patients with highly elevated Lp(a) levels', 'lipoprotein(a) [Lp(a', 'Patients with elevated Lp(a', 'human subjects']","['placebo', 'Lp(a', 'antisense oligonucleotide (IONIS-APO(a)Rx) directed to apolipoprotein(a']","['Clot lysis times and coagulation/fibrinolysis-related biomarkers', 'Lp(a', 'mean (SD) percent change in Lp(a', 'Clot lysis times', 'plasma lipoprotein(a', 'Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, PAI-1, TAFI, and fibrinogen', 'mean (SD) baseline Lp(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079925', 'cui_str': 'Anti-Sense Oligonucleotides'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0200464', 'cui_str': 'Clot Lysis Time'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.129998,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Boffa', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Tanya T', 'Initials': 'TT', 'LastName': 'Marar', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Yeang', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Marlys L', 'Initials': 'ML', 'LastName': 'Koschinsky', 'Affiliation': 'Robarts Research Institute, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA stsimikas@ucsd.edu.'}]",Journal of lipid research,['10.1194/jlr.P094763']
772,31227585,Effects of Exercise in Addition to a Family-Based Lifestyle Intervention Program on Hepatic Fat in Children With Overweight.,"OBJECTIVE


Pediatric hepatic steatosis is highly prevalent and closely related to type 2 diabetes. This study aimed to determine whether the addition of supervised exercise to a family-based lifestyle and psycho-educational intervention results in greater reduction of percentage of hepatic fat (HF), adiposity, and cardiometabolic risk factors in children with overweight/obesity.
RESEARCH DESIGN AND METHODS


The study subjects of this nonrandomized, two-arm, parallel design clinical trial were 116 overweight/obese children (10.6 ± 1.1 years of age, 53.4% girls) living in Vitoria-Gasteiz (Spain). For 22 weeks, they followed either a lifestyle and psycho-education program (control intervention [CInt],  N  = 57), consisting of two family-based education sessions/month, or the same plus supervised exercise (intensive intervention [II],  N  = 59) focused mainly on high-intensity aerobic workouts (3 sessions/week, 90 min/session). The primary outcome was the change in percentage of HF (as measured by MRI) between baseline and the end of the intervention period. Secondary outcomes included changes in BMI, fat mass index (FMI), abdominal fat (measured by DEXA), blood pressure, triglycerides, HDL, LDL, γ-glutamyl transferase, glucose, and insulin concentrations.
RESULTS


A total of 102 children completed the trial ( N  = 53 and  N  = 49 in the CInt and II groups, respectively). Percentage of HF decreased only in the II group (-1.20 ± 0.31% vs. 0.04 ± 0.30%, II and CInt groups, respectively), regardless of baseline value and any change in adiposity ( P  < 0.01). BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
CONCLUSIONS


Multicomponent intervention programs that include exercise training may help to reduce adiposity, insulin resistance, and hepatic steatosis in overweight/obese children.",2020,"BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
","['Children With Overweight', 'overweight/obese children', '116 overweight/obese children (10.6 ± 1.1 years of age, 53.4% girls) living in Vitoria-Gasteiz (Spain', '102 children completed the trial ( N  = 53 and  N  = 49 in the CInt and II groups, respectively', 'children with overweight/obesity']","['exercise training', 'Family-Based Lifestyle Intervention Program', 'supervised exercise to a family-based lifestyle and psycho-educational intervention', 'Exercise', 'lifestyle- and psycho-education program (control intervention [CInt],  N  = 57), consisting of two family-based education sessions/month, or the same plus supervised exercise (intensive intervention [II],  N  = 59) focused mainly on high-intensity aerobic workouts']","['adiposity, insulin resistance, and hepatic steatosis', 'Percentage of HF', 'adiposity', 'changes in BMI, fat mass index (FMI), abdominal fat (measured by DEXA), blood pressure, triglycerides, HDL, LDL, γ-glutamyl-transferase, glucose, and insulin concentrations', 'percentage of hepatic fat (HF), adiposity, and cardiometabolic risk factors', 'BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin', 'change in percentage of HF (as measured by MRI', 'Hepatic Fat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",116.0,0.0728099,"BMI, FMI, abdominal fat ( P  ≤ 0.001), and insulin ( P  < 0.05) were reduced in both groups.
","[{'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain idoia.labayen@unavarra.es.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Medrano', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Lide', 'Initials': 'L', 'LastName': 'Arenaza', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Maíz', 'Affiliation': 'University of the Basque Country, Donostia, Spain.'}, {'ForeName': 'Maddi', 'Initials': 'M', 'LastName': 'Osés', 'Affiliation': 'Institute for Innovation & Sustainable Development in the Food Chain (IS-FOOD), Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martínez-Vizcaíno', 'Affiliation': 'Health and Social Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Department of Physical and Sports Education, Faculty of Sports Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Department of Physical and Sports Education, Faculty of Sports Sciences, University of Granada, Granada, Spain.'}]",Diabetes care,['10.2337/dc19-0351']
773,31215805,Urine citrate excretion identifies changes in acid retention as eGFR declines in patients with chronic kidney disease.,"Previous studies have shown that acid (H + ) retention in patients with chronic kidney disease (CKD) but without metabolic acidosis increases as the estimated glomerular filtration rate (eGFR) decreases over time. The present study examined whether changes in urine excretion of the pH-sensitive metabolite citrate predicted changes in H +  retention over time in similar patients with CKD that were followed for 10 yr. We randomized 120 CKD2 nondiabetic, hypertension-associated nephropathy patients with plasma total CO 2  of >24 mM to receive 0.5 meq·kg body wt -1 ·day -1  NaHCO 3  ([Formula: see text];  n  = 40), 0.5 meq·kg body wt -1 ·day -1  NaCl (NaCl;  n  = 40), or usual care (UC;  n  = 40). We assessed eGFR (CKD-EPI) and H +  retention by comparing the observed with expected plasma total CO 2  increase 2 h after an oral NaHCO 3  bolus (0.5 meq/kg body wt). Although 10 yr versus baseline eGFR was lower for each group, 10-yr eGFR was higher ( P  < 0.01) in [Formula: see text] (59.6 ± 4.8 ml·min -1 ·1.73 m -2 ) than NaCl and UC (52.1 ± 5.9 and 52.3 ± 4.1 ml·min -1 ·1.73 m -2 , respectively) groups. Less eGFR preservation was associated with higher 10-yr versus baseline H +  retention in the NaCl group (26.5 ± 13.1 vs. 18.2 ± 15.3 mmol,  P  < 0.01) and UC group (24.8 ± 11.3 vs. 17.7 ± 10.9 mmol,  P  < 0.01) and with lower 10-yr versus baseline 8-h urine citrate excretion (U citrate V) for the NaCl group (162 ± 47 vs. 196 ± 52 mg, respectively,  P  < 0.01) and UC group (153 ± 41 vs. 186 ± 42 mg, respectively,  P  < 0.01). Conversely, better eGFR preservation in the [Formula: see text] group was associated with no differences in 10-yr versus baseline H +  retention (14.2 ±13.5 vs. 16.1 ± 15.1 mmol,  P  = 1.00) or U citrate V (212 ± 45 vs. 203 ± 49 mg, respectively,  P  = 0.74). An overall generalized linear model for repeated measures showed that U citrate V predicted H +  retention ( P  < 0.01). Less eGFR preservation in patients with CKD2 without metabolic acidosis was associated with increased H +  retention that was predicted by decreased U citrate V.",2019,An overall generalized linear model for repeated measures showed that U citrate V predicted H +  retention (p<0.01).,"['patients with chronic kidney disease (CKD) stage 2 eGFR (60-89 ml ', '120 CKD 2 non-diabetic, hypertension-associated nephropathy patients with plasma total CO 2  (PTCO 2 ) > 24 mM to receive 0.5 mEq/kg bw/day NaHCO 3  (HCO 3 - , n=40), 0.5 mEq/kg bw/day NaCl (NaCl, n=40), or Usual Care (UC, n=40', 'patients with chronic kidney disease']",['min-1.73m-2'],"['acid (H + ) retention', 'eGFR preservation', '10-year eGFR', 'eGFR (CKD-EPI) and H +  retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316786', 'cui_str': 'CKD stage 2'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}]",120.0,0.0296586,An overall generalized linear model for repeated measures showed that U citrate V predicted H +  retention (p<0.01).,"[{'ForeName': 'Nimrit', 'Initials': 'N', 'LastName': 'Goraya', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Temple, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Sager', 'Affiliation': 'Baylor Scott and White Health Department of Biostatistics, Temple, Texas.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, Texas.'}, {'ForeName': 'Nicolaos E', 'Initials': 'NE', 'LastName': 'Madias', 'Affiliation': ""School of Medicine, Department of Medicine, St. Elizabeth's Medical Center and Tufts University, Boston, Massachusetts.""}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Dallas, Texas.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00044.2019']
774,31215985,Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial.,"Importance


Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative.
Objective


To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery.
Design, Setting, and Participants


In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017.
Interventions


A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR.
Main Outcomes and Measures


The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year.
Results


Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04).
Conclusions and Relevance


Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
Trial Registration


ClinicalTrials.gov identifier: NCT01586910.",2019,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
","['1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR', 'Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery', 'patients at intermediate operative risk with prior CABG surgery', 'A total of 1746 patients', '136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years', 'patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery', 'patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017']","['Transcatheter vs Surgical Aortic Valve Replacement', 'Transcatheter aortic valve replacement (TAVR', 'Surgical Replacement and Transcatheter Aortic Valve Implantation', 'Surgical aortic valve replacement (SAVR', 'self-expanding TAVR or SAVR', 'TAVR and SAVR']","['quality of life and better exercise capacity', 'mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score', 'mean (SD) improvement in distance walked', 'cause mortality or disabling stroke', 'mean (SD) Kansas City Cardiomyopathy Questionnaire summary score', 'quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year', 'mortality or disabling stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon (occupation)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",1746.0,0.172768,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Heijmen', 'Affiliation': 'St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Watson', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hockmuth', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Petrossian', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'Newell', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1856']
775,31112652,The Link Between Verbal Short-Term Memory and Anomia Treatment Gains.,"Purpose A significant relationship between verbal short-term memory (STM) and language performance in people with aphasia has been found across studies. However, very few studies have examined the predictive value of verbal STM in treatment outcomes. This study aims to determine if verbal STM can be used as a predictor of treatment success. Method Retrospective data from 25 people with aphasia in a larger randomized controlled trial of phonomotor treatment were analyzed. Digit and word spans from immediately pretreatment were run in multiple linear regression models to determine whether they predict magnitude of change from pre- to posttreatment and follow-up naming accuracy. Pretreatment, immediately posttreatment, and 3 months posttreatment digit and word span scores were compared to determine if they changed following a novel treatment approach. Results Verbal STM, as measured by digit and word spans, did not predict magnitude of change in naming accuracy from pre- to posttreatment nor from pretreatment to 3 months posttreatment. Furthermore, digit and word spans did not change from pre- to posttreatment or from pretreatment to 3 months posttreatment in the overall analysis. A post hoc analysis revealed that only the less impaired group showed significant changes in word span scores from pretreatment to 3 months posttreatment. Discussion The results suggest that digit and word spans do not predict treatment gains. In a less severe subsample of participants, digit and word span scores can change following phonomotor treatment; however, the overall results suggest that span scores may not change significantly. The implications of these findings are discussed within the broader purview of theoretical and empirical associations between aphasic language and verbal STM processing.",2019,"Furthermore, digit and word spans did not change from pre- to posttreatment or from pretreatment to 3 months posttreatment in the overall analysis.","['people with aphasia', '25 people with aphasia']",['verbal short-term memory (STM'],"['Furthermore, digit and word spans', 'word span scores']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]","[{'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",25.0,0.0561258,"Furthermore, digit and word spans did not change from pre- to posttreatment or from pretreatment to 3 months posttreatment in the overall analysis.","[{'ForeName': 'Reva M', 'Initials': 'RM', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle.'}, {'ForeName': 'JoAnn P', 'Initials': 'JP', 'LastName': 'Silkes', 'Affiliation': 'San Diego State University, CA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kendall', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Minkina', 'Affiliation': 'Communication Sciences and Disorders, Temple University, Philadelphia, PA.'}]",American journal of speech-language pathology,['10.1044/2019_AJSLP-18-0176']
776,31128953,Novel Smartphone Game Improves Physical Activity Behavior in Type 2 Diabetes.,"INTRODUCTION


Many type 2 diabetes patients show insufficient levels of physical activity and are often unmotivated to change physical activity behaviors. This study investigated whether a newly developed smartphone game delivering individualized exercise and physical activity promotion through an elaborate storyline can generate sustained improvements in daily physical activity (steps/day).
STUDY DESIGN


Thirty-six participants were enrolled in this 24-week RCT between August 2016 and April 2018. After baseline assessment, participants were randomized in equal numbers to the intervention or control condition. Data analysis was performed in May-June 2018.
SETTING/PARTICIPANTS


Inactive, overweight type 2 diabetes patients, aged 45-70 years, were recruited through advertising and from hospitals and diabetes care centers in the Basel, Switzerland, metropolitan area.
INTERVENTION


Participants were instructed to play the innovative smartphone game (intervention group) or to implement the recommendations from the baseline lifestyle counseling (control group) autonomously during the 24-week intervention period.
MAIN OUTCOME MEASURES


Primary outcomes were changes in daily physical activity (steps/day); changes in aerobic capacity, measured as oxygen uptake at the first ventilatory threshold; and changes in glycemic control, measured as HbA1c.
RESULTS


Daily physical activity increased by an average of 3,998 (SD=1,293) steps/day in the intervention group and by an average of 939 (SD=1,156) steps/day in the control group. The adjusted difference between the two groups was 3,128 steps/day (95% CI=2,313, 3,943, p<0.001). The increase in daily physical activity was accompanied by an improved aerobic capacity (adjusted difference of oxygen uptake at the first ventilatory threshold of 1.9 mL/(kg·min), 95% CI=0.9, 2.9, p<0.001). Glycemic control (HbA1c) did not change over the course of the intervention.
CONCLUSIONS


A novel, self-developed smartphone game, delivering multidimensional home-based exercise and physical activity promotion, significantly increases daily physical activity (steps/day) and aerobic capacity in inactive type 2 diabetes patients after 24 weeks. The ability of the game to elicit a sustained physical activity motivation may be relevant for other inactive target groups with chronic diseases.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02657018.",2019,"RESULTS


Daily physical activity increased by an average of 3,998 (SD=1,293) steps/day in the intervention group and by an average of 939 (SD=1,156) steps/day in the control group.","['Inactive, overweight type 2 diabetes patients, aged 45-70 years, were recruited through advertising and from hospitals and diabetes care centers in the Basel, Switzerland, metropolitan area', 'Thirty-six participants were enrolled in this 24-week RCT between August 2016 and April 2018', 'inactive type 2 diabetes patients after 24 weeks', 'Type 2 Diabetes']","['Novel Smartphone Game', 'innovative smartphone game (intervention group) or to implement the recommendations from the baseline lifestyle counseling (control group) autonomously during the 24-week intervention period']","['changes in daily physical activity (steps/day); changes in aerobic capacity, measured as oxygen uptake at the first ventilatory threshold; and changes in glycemic control, measured as HbA1c', 'daily physical activity', 'Glycemic control (HbA1c', 'aerobic capacity', 'daily physical activity (steps/day) and aerobic capacity', 'Physical Activity Behavior', 'Daily physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",36.0,0.0864145,"RESULTS


Daily physical activity increased by an average of 3,998 (SD=1,293) steps/day in the intervention group and by an average of 939 (SD=1,156) steps/day in the control group.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland; Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Müller', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Ambühl', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Klenk', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Königstein', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Infanger', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Steffen P', 'Initials': 'SP', 'LastName': 'Walz', 'Affiliation': 'Centre for Design Innovation, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Schmidt-Trucksäss', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland. Electronic address: arno.schmidt-trucksaess@unibas.ch.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.02.017']
777,31194584,Evaluation of interventions to make top tether hardware more visible during child restraint system (CRS) installations.,"Objectives:  The objective of the study is to determine whether specific child restraint system (CRS) or vehicle conditions improve top tether attachment rates during volunteer installations.  Methods:  A factorial randomized controlled trial was designed to evaluate 4 different experimental categories: (1) Color of tether adjuster casing (black or red), (2) labeling on tether adjuster casing (labeled with ""Tether: Use for forward-facing"" or unlabeled), (3) storage location of tether (bundled in a rubber band on the back of CRS or Velcroed over the forward-facing belt path), and (4) labeling in vehicle (labeled under head restraint and below anchor or unlabeled). Ninety-six volunteers were randomly assigned to one combination of conditions. One installation per volunteer was completed. The primary outcome measure was acceptable attachment of the top tether to the tether anchor. The secondary outcome measure was overall secureness of the installation. Pearson's chi-square tests were used to identify significant predictors of acceptable outcomes and logistic regression was used to investigate interaction effects.  Results:  A total of 66/96 subjects (68.8%) attached the top tether in an acceptable manner, with either zero errors ( n  = 50) or minor errors ( n  = 16). A total of 30/96 subjects (31.2%) had unacceptable tether outcomes, with either major errors ( n  = 10) or nonuse the tether at all ( n  = 20). None of the 4 experimental categories significantly affected tether outcomes. Subjects who opted to install the CRS with the lower anchors (LAs) had higher rates of acceptable tether attachment compared to subjects who installed using the seat belt or those who used both LA and seat belt together (χ 2  = 6.792,  P  = .034). Tether outcomes were not correlated with previous CRS experience, use of instruction manual(s), age, or sex. Only 15.6% of subjects produced overall correct and tight installations. Of those who used the seat belt in some manner, 70.2% neglected to switch the retractor into locking mode.  Conclusions:  Conditions in this study including tether color, tether labeling, storage location, and vehicle labeling did not significantly affect tether attachment rates. High rates of tether misuse and nonuse warrant further exploration to find effective solutions to this usability problem.",2019,"Subjects who opted to install the CRS with the lower anchors (LAs) had higher rates of acceptable tether attachment compared to subjects who installed using the seat belt or those who used both LA and seat belt together (χ 2  = 6.792,  P  = .034).","['A total of 66/96 subjects (68.8%) attached the top tether in an acceptable manner, with either zero errors ( n \u2009=\u200950) or minor errors ( n \u2009=\u200916', 'volunteer installations', 'A total of 30/96 subjects (31.2%) had unacceptable tether outcomes, with either major errors ( n \u2009=\u200910) or nonuse the tether at all ( n \u2009=\u200920', 'Ninety-six volunteers']","['specific child restraint system (CRS) or vehicle conditions', 'Color of tether adjuster casing (black or red), (2) labeling on tether adjuster casing (labeled with ""Tether: Use for forward-facing"" or unlabeled), (3) storage location of tether (bundled in a rubber band on the back of CRS or Velcroed over the forward-facing belt path), and (4) labeling in vehicle (labeled under head restraint and below anchor or unlabeled']","['previous CRS experience, use of instruction manual(s), age, or sex', 'overall secureness of the installation', 'overall correct and tight installations', 'acceptable attachment of the top tether to the tether anchor']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0577538', 'cui_str': 'Tethered (qualifier value)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0577538', 'cui_str': 'Tethered (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0453982', 'cui_str': 'Velcro (physical object)'}, {'cui': 'C0452227', 'cui_str': 'Belt, device (physical object)'}, {'cui': 'C0441464', 'cui_str': 'Head restraint (physical object)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}]","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0577538', 'cui_str': 'Tethered (qualifier value)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}]",96.0,0.0330843,"Subjects who opted to install the CRS with the lower anchors (LAs) had higher rates of acceptable tether attachment compared to subjects who installed using the seat belt or those who used both LA and seat belt together (χ 2  = 6.792,  P  = .034).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mansfield', 'Affiliation': 'a Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences , The Ohio State University , Columbus , Ohio.'}, {'ForeName': 'Yadetsie N', 'Initials': 'YN', 'LastName': 'Zaragoza-Rivera', 'Affiliation': 'a Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences , The Ohio State University , Columbus , Ohio.'}, {'ForeName': 'Gretchen H', 'Initials': 'GH', 'LastName': 'Baker', 'Affiliation': 'a Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences , The Ohio State University , Columbus , Ohio.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Bolte', 'Affiliation': 'a Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences , The Ohio State University , Columbus , Ohio.'}]",Traffic injury prevention,['10.1080/15389588.2019.1618849']
778,31217148,Coronary vasomotor function and myocardial flow with bioresorbable vascular scaffolds or everolimus-eluting metallic stents: a randomised trial.,"AIMS


The aim of this study was to compare the hyperaemic flow and vasomotor response to endothelium-dependent stimuli between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) at 13 months.
METHODS AND RESULTS


Seventy non-diabetic patients aiming to achieve complete revascularisation were randomised 1:1 to BVS or EES implantation. At 13 months, invasive coronary angiography was performed using intracoronary pressure and Doppler ultrasound measurements at rest and maximal hyperaemia. A vasomotor test to endothelium-dependent (acetylcholine) and independent (nitroglycerine) stimuli and optical coherence tomography (OCT) were also performed. Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination. Doppler ultrasound average peak velocity (49.0±17.5 vs 49.3±18.3 cm/sec; p=0.95), coronary blood flow (97.4±53.5 vs 88.3±46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs 0.94±0.04; p=0.17) were similar between the groups. The vasomotor test showed vasoconstriction response to acetylcholine in 75.6% proximal and 72.2% distal peri-scaffold segments without differences between study devices. BVS had larger in-scaffold vasoconstriction than EES (60.0% vs 27.6%; p=0.01) despite similar neointima response as assessed by OCT.
CONCLUSIONS


BVS and EES had similar microcirculatory response to hyperaemia and predominant vasoconstrictive response in the peri-scaffold segments to endothelium-dependent stimuli. However, BVS exhibited larger vasoconstriction to endothelium-dependent stimuli in the scaffold segment.",2020,"Doppler-ultrasound average peak velocity (49.0±17.5 vs. 49.3±18.3 cm/sc.; p=0.95), coronary blood flow (97.4±53.5 vs. 88.3 ± 46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs. 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs. 0.94±0.04; p=0.17) were similar between groups.","['Seventy non-diabetic patients aimed to achieve complete revascularization', 'patients treated with everolimus-eluting bioresorbable scaffolds and everolimus-eluting metallic stents', 'Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination']","['Vasomotor test to endothelial-dependent (acetylcholine) and independent (nitroglycerine) stimuli and Optical Coherence Tomography (OCT', 'BVS or EES implantation', 'Bioresorbable Vascular Scaffolds (BVS) and metallic Everolimus-Eluting Stents (EES', 'acetylcholine']","['fractional flow reserve', 'vasoconstriction response', 'coronary blood flow', 'Doppler-ultrasound average peak velocity', 'coronary flow reserve', 'hyperemic flow and vasomotor response', 'neointima response']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2936380', 'cui_str': 'Neointima'}]",70.0,0.0565155,"Doppler-ultrasound average peak velocity (49.0±17.5 vs. 49.3±18.3 cm/sc.; p=0.95), coronary blood flow (97.4±53.5 vs. 88.3 ± 46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs. 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs. 0.94±0.04; p=0.17) were similar between groups.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': 'Grup de Recerca en Malalties del Cor, Hospital Universitari de Bellvitge; Institut d´Investigacio Biomedica de Bellvitge (IDIBELL), Universitat de Barcelona, L´Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Salvatella', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ''}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ñato', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Roura', 'Affiliation': ''}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Ferreiro', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Teruel', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Gracida', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Vaquerizo', 'Affiliation': ''}, {'ForeName': 'Àngel', 'Initials': 'À', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Joan-Antoni', 'Initials': 'JA', 'LastName': 'Gomez-Hospital', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-01203']
779,31230371,"Mepolizumab failed to affect bullous pemphigoid: A randomized, placebo-controlled, double-blind phase 2 pilot study.",,2020,,[],"['Mepolizumab', 'placebo']",[],[],"[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.499789,,"[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Simon', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Shida', 'Initials': 'S', 'LastName': 'Yousefi', 'Affiliation': 'Institute of Pharmacology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cazzaniga', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bürgler', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Radonjic', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Houriet', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Heidemeyer', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hans-Wilhelm', 'Initials': 'HW', 'LastName': 'Klötgen', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Kozlowski', 'Affiliation': 'Institute of Pharmacology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Borradori', 'Affiliation': 'Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hans-Uwe', 'Initials': 'HU', 'LastName': 'Simon', 'Affiliation': 'Institute of Pharmacology, University of Bern, Bern, Switzerland.'}]",Allergy,['10.1111/all.13950']
780,31176889,The online treatment of suicidal ideation: A randomised controlled trial of an unguided web-based intervention.,"Suicide is a major public health issue, and treatment of suicidal thoughts may contribute to its prevention. Provision of online treatment of suicidal ideation may reduce barriers that suicidal individuals experience in face-to-face treatment. We therefore aimed at evaluating the effectiveness of a web-based intervention targeting a reduction of suicidal ideation. We carried out a two-arm, parallel-design, randomised controlled trial in the general population in Flanders (Belgium) (registered as NCT03209544). Participants who were 18 years or older and experienced suicidal ideation were included. The intervention group (n = 365) received access to the unguided web-based intervention, and the control group (n = 359) was placed on a waitlist. Assessments were carried out at baseline and at 6 and 12 weeks. Participants reported high levels of suicidal ideation, depression, hopelessness, worrying, and anxiety at baseline. Compared to the control group, participants in the intervention group experienced a significant decline in suicidal ideation, depression, hopelessness, worrying, and anxiety both at post-test and at follow-up. An important limitation of the study was a high dropout rate, in particular in the intervention group. Our findings suggest that the online self-help intervention was more effective in reducing suicidal ideation and suicide-related symptoms than a waitlist control in a severely affected population. It can help in filling the gap between crisis help and face-to-face treatment.",2019,Our findings suggest that the online self-help intervention was more effective in reducing suicidal ideation and suicide-related symptoms than a waitlist control in a severely affected population.,"['Participants who were 18 years or older and experienced suicidal ideation were included', 'general population in Flanders (Belgium) (registered as NCT03209544']","['access to the unguided web-based intervention, and the control group (n\u202f=\u202f359) was placed on a waitlist', 'unguided web-based intervention']","['suicidal ideation and suicide-related symptoms', 'high levels of suicidal ideation, depression, hopelessness, worrying, and anxiety', 'suicidal ideation', 'suicidal ideation, depression, hopelessness, worrying, and anxiety']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0563727,Our findings suggest that the online self-help intervention was more effective in reducing suicidal ideation and suicide-related symptoms than a waitlist control in a severely affected population.,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'De Jaegere', 'Affiliation': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University, Corneel Heymanslaan 10, entr. 17, 9000, Ghent, Belgium. Electronic address: eva.dejaegere@ugent.be.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'van Landschoot', 'Affiliation': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University, Corneel Heymanslaan 10, entr. 17, 9000, Ghent, Belgium.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'van Heeringen', 'Affiliation': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University, Corneel Heymanslaan 10, entr. 17, 9000, Ghent, Belgium.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, College of Health and Medicine, Australian National University, 63 Eggleston Road, Acton, ACT, 2601, Australia.'}, {'ForeName': 'Ad J F M', 'Initials': 'AJFM', 'LastName': 'Kerkhof', 'Affiliation': 'Department of Clinical Neuro and Developmental Psychology, VU University Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Mokkenstorm', 'Affiliation': '113 Suicide Prevention, Paasheuvelweg 25, 1105BP, Amsterdam, Netherlands; Amsterdam Public Health, Department of Psychiatry, Amsterdam UMC, De Boelelaan 1117, 1081 HV, Amsterdam, Netherlands.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Portzky', 'Affiliation': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University, Corneel Heymanslaan 10, entr. 17, 9000, Ghent, Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.05.003']
781,31597084,Functional connectivity underpinning changes in life-space mobility in older adults with mild cognitive impairment: A 12-month prospective study.,"Subtle changes in mobility exist among older adults with mild cognitive impairment (MCI). Life-space mobility defines the frequency and extent of movements in the environment, and lower life-space mobility is associated with adverse health outcomes and MCI. Currently, the underlying mechanism of this association is not well understood. This study examined the functional neural correlates of life-space mobility in community-dwelling older adults with MCI. We first conducted a cross-sectional investigation of the association between resting-state default mode network (DMN) and sensori-motor network (SMN) connectivity and life-space mobility (assessed by the Life-Space Assessment (LSA)) among 60 community-dwelling older adults with MCI using aggregated data from two studies - baseline data from a randomized controlled trial (n = 20) and baseline data from a 12-month prospective study (n = 40). Using data from the 12-month prospective study (n = 35), we then examined whether baseline internetwork connectivity predicts reduced life-space mobility over 12 months. The cross-sectional analysis showed higher DMN-SMN connectivity was associated with lower LSA scores after adjusting for baseline global cognitive function and baseline age (p < 0.01). A significant reduction in LSA scores was observed in the 35 participants of the 12-month prospective study (paired sample t-test mean change = -6.53, p = 0.01). Greater baseline DMN-SMN connectivity was associated with greater reduction in life-space mobility at 12 months (p = 0.04) after adjusting for baseline age, global cognitive function, and LSA score. Our findings suggest that lower and reduced life-space mobility in older adults with MCI may be due to altered functional architecture of the brain such that normal neuro-cognitive motor behaviours may be disrupted.",2020,"Greater baseline DMN-SMN connectivity was associated with greater reduction in life-space mobility at 12 months (p = 0.04) after adjusting for baseline age, global cognitive function, and LSA score.","['60 community-dwelling older adults with MCI using aggregated data from two studies - baseline data from a randomized controlled trial (n\u2009=\u200920) and baseline data from a 12-month prospective study (n\u2009=\u200940', '35 participants of the 12-month prospective study (paired sample t-test mean', 'older adults with mild cognitive impairment', 'community-dwelling older adults with MCI', 'older adults with MCI', 'older adults with mild cognitive impairment (MCI']",['resting-state default mode network (DMN) and sensori-motor network (SMN) connectivity and life-space mobility (assessed by the Life-Space Assessment (LSA'],"['LSA scores', 'life-space mobility', 'Greater baseline DMN-SMN connectivity', 'DMN-SMN connectivity', 'global cognitive function, and LSA score']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",60.0,0.0346397,"Greater baseline DMN-SMN connectivity was associated with greater reduction in life-space mobility at 12 months (p = 0.04) after adjusting for baseline age, global cognitive function, and LSA score.","[{'ForeName': 'Chun Liang', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Crockett', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lisanne Ten', 'Initials': 'LT', 'LastName': 'Brinke', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Doherty', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, University of British Columbia, Vancouver, British Columbia, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada; Djavad Mowafaghian Center for Brain Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada; Center for Hip Health and Mobility, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: teresa.ambrose@ubc.ca.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112216']
782,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES


Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO).
SUBJECTS/METHODS


Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant.
RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03).
CONCLUSION


In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7']
783,31481504,A Phase I Study of the Combination of Rituximab and Ipilimumab in Patients with Relapsed/Refractory B-Cell Lymphoma.,"PURPOSE


Based on the potential for ipilimumab (I) to augment T-cell activation, we hypothesize that ipilimumab would augment the efficacy of rituximab (R) in patients with relapsed/refractory (R/R) CD20 + non-Hodgkin's lymphoma (NHL). This phase I study aimed to identify a recommended phase 2 dose, document toxicities, and preliminarily assess efficacy and potential predictive biomarkers.
PATIENTS AND METHODS


Thirty-three patients with R/R CD20 + B-cell lymphoma received R at 375 mg/m 2 weekly for 4 weeks and I at 3 mg/kg on day 1 and every 3 weeks for four doses. Responding patients went on to maintenance with each agent given every 12 weeks. To facilitate correlative analysis, the expansion phase randomized patients to simultaneous R+I versus R with I delayed 2 weeks.
RESULTS


Toxicity was manageable; no dose-limiting toxicity was observed at the doses studied. When considering the entire cohort, efficacy was modest, with an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 2.6 months. However, in follicular lymphoma patients, the ORR was 58% with a median PFS of 5.6 months. The randomized comparison of R with R+I demonstrated that R+I resulted in more effective B-cell depletion (BCD). Both B-cell depletion and the ratio of CD45RA - regulatory T cell (Treg) to Treg were associated with response at all time points.
CONCLUSIONS


The combination of R+I has manageable toxicity and encouraging efficacy in R/R follicular lymphoma. The ratio of CD45RA - Tregs to total Tregs, and peripheral BCD should be studied further as potential predictors of response.",2019,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","['Thirty-three patients with R/R CD20+ B-cell lymphoma received R at 375mg/m 2  weekly for 4 weeks and', 'patients with relapsed/refractory (R/R) CD20+ NHL', 'Patients with Relapsed/Refractory B-Cell Lymphoma']",['Rituximab and Ipilimumab'],"['median progression-free survival (PFS', 'objective response rate (ORR', 'ORR', 'effective B cell depletion (BCD', 'limiting toxicity']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",33.0,0.0214727,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Tuscano', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, California. jtuscano@ucdavis.edu.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Denice', 'Initials': 'D', 'LastName': 'Tsao-Wei', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Luxardi', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Merleev', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Beaven', 'Affiliation': 'University of North Carolina Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Popplewell', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kirschbaum', 'Affiliation': 'Taiho Oncology, Princeton, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schroeder', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Newman', 'Affiliation': 'Division of Molecular Pharmacology, Department of Medical Oncology, City of Hope, Duarte, California, USA.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0438']
784,31203649,Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults.,"OBJECTIVE


Behavioral treatments for insomnia improve sleep in older adults, but research documenting their effects on cognitive performance is mixed. We explored whether a brief behavioral treatment for insomnia (BBTi) impacts daily associations between sleep parameters and next day cognition.
METHODS


Sixty-two older adults ( M age   = 69.45 years,  SD  = 7.71) with insomnia completed either 4 weeks of BBTi or self-monitoring control (SMC). At baseline, post-treatment, and 3 month follow-up, participants completed 14 days of diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series). At each time period, associations between sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd  Edition scores), were examined through multilevel modeling.
RESULTS


At post-treatment, we observed an interactive fixed effect of treatment condition (i.e., BBTi/SMC) and TST on daily SDMT and letter series performance. For BBTi, longer TST was associated with better letter series performance, and did not predict SDMT performance. For SMC, longer TST was associated with worse SDMT, and was not associated with letter series performance. Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment. Associations were not maintained at follow-up.
CONCLUSIONS


Sleep duration may play an important role in BBTi-related improvements in daily higher order cognition. Maintenance of these associations may be facilitated by booster sessions following post-treatment.
CLINICAL TRIAL IDENTIFIER


NCT02967185.",2020,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"['Sixty-two older adults ( M age \xa0 ', '69.45\xa0years,  SD\xa0 =\xa07.71) with insomnia completed either 4\xa0weeks of BBTi or self-monitoring control (SMC', 'Older Adults', 'older adults']",['Brief Behavioral Treatment'],"['diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series', 'Greater WASO', 'SDMT performance', 'sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd  Edition scores']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517861', 'cui_str': '7.71'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.0251172,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'TIRR Memorial Hermann , Houston, TX.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Dautovich', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Joseph P H', 'Initials': 'JPH', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida , Gainesville, FL.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Stripling', 'Affiliation': 'College of Psychology, Nova Southeastern University , Fort Lauderdale, Florida.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'College of Medicine, University of Florida , Gainesville, FL.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System , San Antonio, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida , Gainesville, FL.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1632201']
785,31202003,Efficacy of an internet and app-based gratitude intervention in reducing repetitive negative thinking and mechanisms of change in the intervention's effect on anxiety and depression: Results from a randomized controlled trial.,"Repetitive negative thinking (RNT) has been identified as a transdiagnostic process that is involved in various forms of psychopathology, including anxiety and depression. This randomized controlled trial compared a 5-week internet and app-based gratitude intervention (intervention group; IG) with adherence-focused guidance against a wait list control group (WLG) in reducing RNT in a sample with elevated RNT.
METHOD


A total of 260 individuals were randomized to either the IG or the WLG. Data were collected at baseline (T1), within one week post intervention (T2), and at three (3-MFU) and six-months of follow-up (6-MFU; for IG only). The primary outcome was RNT. Secondary outcomes included other mental health outcomes and resilience factors.
RESULTS


Participants of the IG reported significantly less RNT at T2 (d = 0.61) and 3-MFU (d = 0.75) as compared to WLG. Improvements were sustained until 6-MFU. Significant, small to moderate effect sizes were identified for most secondary outcomes at T2 and 3-MFU. Furthermore, results of mediation analyses revealed that the gratitude intervention exerts its effect on anxiety and depression by reducing the risk factor of RNT, while the mediating role of resilience was less clear.
CONCLUSIONS


The gratitude intervention investigated in this study was found to be effective in reducing RNT. Gratitude interventions might affect mental health by two parallel pathways: increasing resources and reducing risk factors.
REFERENCE NUMBER ETHICS COMMITTEE OF THE UNIVERSITY OF LUENEBURG


EB 201701-03-Lehr.
CLINICAL TRIAL REGISTRATION NUMBER


DRKS00011862. The trial protocol can be assessed at: https://www.drks.de/.",2019,Participants of the IG reported significantly less RNT at T2 (,['260 individuals'],"['WLG', 'Repetitive negative thinking (RNT', '3-MFU ', 'Gratitude interventions', 'internet and app-based gratitude intervention', '5-week internet and app-based gratitude intervention (intervention group; IG) with adherence-focused guidance against a wait list control group (WLG']","['anxiety and depression', 'mental health outcomes and resilience factors']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0424134', 'cui_str': 'Negative Thinking'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",260.0,0.115582,Participants of the IG reported significantly less RNT at T2 (,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Heckendorf', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lehr', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany. Electronic address: lehr@leuphana.de.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University of Erlangen-Nuremberg, Naegelsbachstr. 25a, 91052, Erlangen, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Freund', 'Affiliation': 'Department of Religion and Psychotherapy, Tabor Protestant University of Applied Sciences, Duererstraße 43, 35039, Marburg, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103415']
786,31728609,Carnoy solution versus GEWF solution for lymph node revealing in colorectal cancer: a randomized controlled trial.,"PURPOSE


This study aimed to compare the performance of two lymph node revealing solutions.
METHODS


This randomized clinical trial (NTC02704988) investigated patients with colon or rectal cancer who underwent surgical resection with D2 lymphadenectomy. Specimens submitted for conventional pathological examination were randomly assigned for additional fixation with Carnoy or GEWF solution, and dissection was performed to examine the missed lymph nodes. The number of lymph nodes retrieved, additional identified metastatic lymph nodes, lymph node upstaging, and complementary indication of adjuvant therapy were investigated.
RESULTS


The number of lymph nodes retrieved was significantly higher with the use of lymph node revealing solutions than with the conventional method in colon cancer (GEWF: 29.5 vs 27; p < 0.001; Carnoy: 27.7 vs 25.2; p < 0.001) and rectal cancer (GEWF: 25.8 vs 23.6; p < 0.001; Carnoy: 23.1 vs 20.8; p < 0.001). There were no differences between the solutions and conventional examination with respect to the median number of additional metastatic lymph nodes identified (0 in all arms), the number of patients with lymph node upstaging (colon cancer: 1 in the Carnoy arm, 0 in the GEWF arm; rectal cancer: 1 in the GEWF arm, 0 in the Carnoy arm), or the number of patients with complementary indication of adjuvant therapy (colon cancer: 1 in the Carnoy arm, 0 in the GEWF arm; rectal cancer: 0 in both arms).
CONCLUSION


Despite the higher number of lymph nodes retrieved, neither solution resulted in significant changes in patient staging or treatment. Both solutions exhibited equal performance with respect to all outcomes.
TRIAL REGISTRATION


NTC02704988.",2019,The number of lymph nodes retrieved was significantly higher with the use of lymph node revealing solutions than with the conventional method in colon cancer (GEWF: 29.5 vs 27; p < 0.001; Carnoy: 27.7 vs 25.2;,"['Specimens submitted for conventional pathological examination', 'colorectal cancer', 'patients with colon or rectal cancer who underwent']","['surgical resection with D2 lymphadenectomy', 'Carnoy solution versus GEWF solution', 'additional fixation with Carnoy or GEWF solution, and dissection']","['median number of additional metastatic lymph nodes', 'rectal cancer', 'number of lymph nodes']","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0054815', 'cui_str': ""Carnoy's solution""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]",,0.275669,The number of lymph nodes retrieved was significantly higher with the use of lymph node revealing solutions than with the conventional method in colon cancer (GEWF: 29.5 vs 27; p < 0.001; Carnoy: 27.7 vs 25.2;,"[{'ForeName': 'Tiago L', 'Initials': 'TL', 'LastName': 'Ghezzi', 'Affiliation': 'Division of Coloproctology, Hospital Moinhos de Vento, 2350 Ramiro Barcelos St, 600, Porto Alegre, RS, 90035-903, Brazil. tghezzi@hcpa.edu.br.'}, {'ForeName': 'Márcia P', 'Initials': 'MP', 'LastName': 'Pereira', 'Affiliation': 'Anatpat Surgical Pathology Lab, Porto Alegre, Brazil.'}, {'ForeName': 'Oly C', 'Initials': 'OC', 'LastName': 'Corleta', 'Affiliation': 'Division of General Surgery, Department of Surgery, Hospital de Clinicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Antonio N', 'Initials': 'AN', 'LastName': 'Kalil', 'Affiliation': 'Post-graduate Program in Health Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil.'}]",International journal of colorectal disease,['10.1007/s00384-019-03437-5']
787,31781802,Adductor canal block is similar to femoral nerve block for the quality of rehabilitation after arthroscopic partial meniscectomy.,"PURPOSE


Adductor canal block (ACB) provides postoperative pain relief as effectively as femoral nerve block (FNB) does, and it preserves the strength of the quadriceps femoris. However, its effect on rehabilitation after arthroscopic partial meniscectomy has not been reported. The purpose of this study was to determine the effect of pre-operative ACB and FNB on the quality of rehabilitation after arthroscopic partial meniscectomy.
METHODS


A total of 150 patients undergoing arthroscopic partial meniscectomy were randomly allocated to the FNB group (receiving 0.3% ropivacaine 30 ml at the thighroot-femoral nerve), the ACB group (receiving 0.3% ropivacaine 30 ml at mid-thigh adductor canal), or the control group. The primary outcome was the Hospital for Special Surgery (HSS) knee score on the 30th postoperative day.
RESULTS


The HSS knee score of the ACB group on the 30th day after the operation was significantly higher than those of the FNB and control groups (88.6 ± 5.3 vs. 85.3 ± 6.9 and 81.2 ± 5.9, respectively; P < 0.05). Both the ACB and FNB groups showed excellent rehabilitation, indicating similar rehabilitation quality for both treatments.
CONCLUSION


ACB is similar to FNB concerning the quality of rehabilitation and pain relief after arthroscopic partial meniscectomy, while ACB has little effect on the strength of the quadriceps femoris.
LEVEL OF EVIDENCE


I TRIAL REGISTRATAION: This trial was registered in the Chinese Clinical Trial Registry (ChiCTR-INC-16008346).",2020,"ACB is similar to FNB concerning the quality of rehabilitation and pain relief after arthroscopic partial meniscectomy, while ACB has little effect on the strength of the quadriceps femoris.
",['150 patients undergoing arthroscopic partial meniscectomy'],"['Adductor canal block (ACB', 'ACB', 'ACB group (receiving 0.3% ropivacaine', 'pre-operative ACB and FNB', 'FNB group (receiving 0.3% ropivacaine']","['rehabilitation quality', 'HSS knee score', 'Hospital for Special Surgery (HSS) knee score on the 30th postoperative day']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",150.0,0.110396,"ACB is similar to FNB concerning the quality of rehabilitation and pain relief after arthroscopic partial meniscectomy, while ACB has little effect on the strength of the quadriceps femoris.
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xin', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'YanJun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China. liubinhxyy@163.com.""}, {'ForeName': 'Leng', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, West China Hospital of Sichuan University, No.37 Wai Nan Guo Xue Xiang, Chengdu, 610041, Sichuan, People's Republic of China. zhoulenghx@foxmail.com.""}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05796-6']
788,31782023,"Acute effects of photobiomodulation therapy and magnetic field on functional mobility in stroke survivors: a randomized, sham-controlled, triple-blind, crossover, clinical trial.","Identify the optimal energy delivered with a single application of the combination of photobiomodulation therapy (PBMT) combining different light sources (low-level laser therapy-LLLT and light emitting diode therapy-LEDT) and static magnetic field (sMF) in order to determine the acute effects on functional mobility of stroke survivors. Was conducted a randomized, placebo-controlled, crossover, triple-blind, clinical trial (RCT). Twelve patients were recruited, however ten concluded the study, they were randomly treated with four PBMT/sMF energies (sham-0 J, 10 J, 30 J, and 50 J per site irradiated), with 1-week interval washout between treatments. PBMT/sMF were administered after the pre-intervention (baseline) evaluation and the total energy delivered per site at each treatment was determined based on the results of the randomization procedure. PBMT/sMF were administered in direct contact with the skin and applied with slight pressure to nine sites on the knee extensors, six sites on the knee flexors, and two sites on the plantar flexors' muscles in both lower limbs (bilaterally). The primary outcome measure was the 6-min walk test (6MWT) and the secondary outcome was the Timed Up and Go (TUG) test. Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01). And in the TUG test significant improvements were also found using a total energy per site of 30 J per site compared to sham (0 J) and baseline (p < 0.05). PBMT with different light sources (laser and LEDs) and wavelengths in combination with sMF with a total energy per site of 30 J has positive acute effects on functional mobility in stroke survivors.",2020,Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01).,"['Twelve patients were recruited, however ten concluded the study, they were randomly treated with four', 'stroke survivors']","['PBMT with different light sources (laser and LEDs', 'photobiomodulation therapy and magnetic field', 'placebo', 'PBMT/sMF', 'photobiomodulation therapy (PBMT) combining different light sources (low-level laser therapy-LLLT and light emitting diode therapy-LEDT) and static magnetic field (sMF']","['functional mobility', '6MWT test using a total energy', '6-min walk test (6MWT) and the secondary outcome was the Timed Up and Go (TUG) test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0563533', 'cui_str': 'Magnetic Fields'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}]",10.0,0.124809,Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01).,"[{'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Arislander Jonathan Lopes', 'Initials': 'AJL', 'LastName': 'Dumont', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil. arislanderlg@gmail.com.'}, {'ForeName': 'Luiz Alfredo Braun', 'Initials': 'LAB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physiotherapy of the Guairacá College and the Centro-Oeste State University (UNICENTRO), Guarapuava, Parana, Brazil.'}, {'ForeName': 'Paulo Roberto Vicente', 'Initials': 'PRV', 'LastName': 'de Paiva', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Caroline Dos Santos Monteiro', 'Initials': 'CDSM', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Paulo de Tarso Camillo', 'Initials': 'PTC', 'LastName': 'de Carvalho', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Santos', 'Initials': 'CS', 'LastName': 'Oliveira', 'Affiliation': 'Health Sciences Program, Santa Casa School of Medical Sciences of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University (UNINOVE), Sao Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02898-y']
789,31604069,Positive self-perception and corticospinal excitability: Recalling positive behavior expands peripersonal space boundaries.,"Converging evidence suggests that peripersonal space has dynamic properties, that can be influenced by motor and cognitive factors. Here, we investigated whether changes in self-perception may impact upon peripersonal representation. Specifically, employing non-invasive brain stimulation, we tested whether corticospinal excitability elicited by objects placed in the vertical peripersonal vs extrapersonal space can be influenced by changes in self-perception after recalling a personal experience inducing the feeling of high power (vs. positivity vs. low power). In a preliminary study (Study 1, N = 39) participants were presented with an object, whose position was manipulated in the horizontal vs vertical space. We assessed corticospinal excitability by measuring Motor Evoked Potentials (MEPs) using Transcranial Magnetic Stimulation with Electromyography co-registration (TMS-EMG). In the horizontal condition, we replicated the well-known motor facilitation induced by objects falling in the peri vs extrapersonal space, while in the vertical dimension MEPs were higher in the extrapersonal space. In the main experiment (Study 2), participants (N = 55) were randomly assigned to feel high power, low power, or a general positive emotion and were asked to observe the same object positioned either in the peripersonal or in the extrapersonal vertical space. Results showed that in the low power condition MEPs were higher in the extrapersonal vs peripersonal, as in Study 1, while in high power and positive conditions MEPs were not influenced by distance. Taken together, our findings suggest a dissociable pattern of motor facilitation underlying vertical vs horizontal space perception and, crucially, that changes in self-perception can influence such a representation.",2019,"Results showed that in the low power condition MEPs were higher in the extrapersonal vs peripersonal, as in Study 1, while in high power and positive conditions MEPs were not influenced by distance.","['N\u202f=\u202f39) participants', 'participants (N\u202f=\u202f55']","['feel high power, low power, or a general positive emotion and were asked to observe the same object positioned either in the peripersonal or in the extrapersonal vertical space', 'Transcranial Magnetic Stimulation with Electromyography co-registration (TMS-EMG']","['low power condition MEPs', 'Positive self-perception and corticospinal excitability']",[],"[{'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",,0.0459351,"Results showed that in the low power condition MEPs were higher in the extrapersonal vs peripersonal, as in Study 1, while in high power and positive conditions MEPs were not influenced by distance.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vergallito', 'Affiliation': 'University of Milano Bicocca, Department of Psychology, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lo Gerfo', 'Affiliation': 'Clinical Psychology Service of Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCSS IsMeTT) Palermo, Italy; NeuroMI - Milan Center for Neuroscience, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Varoli', 'Affiliation': 'Clinical Psychology Service of Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCSS IsMeTT) Palermo, Italy; University of Milano Bicocca, Department of Medicine and Surgery, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brambilla', 'Affiliation': 'University of Milano Bicocca, Department of Psychology, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sacchi', 'Affiliation': 'University of Milano Bicocca, Department of Psychology, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anzani', 'Affiliation': 'University of Chieti-Pescara ""G. D\'Annunzio"", Department of Neuroscience, Imaging and Clinical Sciences, Italy.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Romero Lauro', 'Affiliation': 'University of Milano Bicocca, Department of Psychology, Italy; NeuroMI - Milan Center for Neuroscience, Italy. Electronic address: Leonor.romero1@unimib.it.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.107224']
790,31777949,A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system.,"OBJECTIVE


To assess the efficacy of ulipristal acetate (UPA) for reducing abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system (LNG-IUS).
METHODS


A randomized, double-blind, placebo-controlled pilot study conducted from September 1, 2016 to September 30, 2018, at the University of Campinas, Brazil. LNG-IUS users reporting prolonged or frequent uterine bleeding for at least 1 year were randomized to receive 5 mg UPA per day for 5 days or placebo at an identical regimen. Bleeding was recorded for 90 days after treatment began and was compared between the groups.
RESULTS


Of 94 eligible women, 64 with abnormal bleeding associated with LNG-IUS use declined treatment or device removal after counselling regarding anticipated bleeding patterns. For the 25 study participants, differences were nonsignificant between the UPA and placebo groups for number of days before bleeding stopped and days free of bleeding; however, UPA users displayed a trend for shorter duration before bleeding stopped and longer time free of bleeding. A similar trend for mean number of bleeding days at 30-, 60-, and 90-day follow-up was observed.
CONCLUSION


A nonsignificant trend in reduction of abnormal bleeding was observed among LNG-IUS users taking 5 mg UPA per day for 5 days compared with placebo; however, further research is needed. CLINICALTRIALS.GOV: NCT03186586.",2020,"For the 25 study participants, differences were nonsignificant between the UPA and placebo groups for number of days before bleeding stopped and days free of bleeding; however, UPA users displayed a trend for shorter duration before bleeding stopped and longer time free of bleeding.","['from September 1, 2016 to September 30, 2018, at the University of Campinas, Brazil', 'LNG-IUS users reporting prolonged or frequent uterine bleeding for at least 1\xa0year', 'abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system', 'women using the 52-mg levonorgestrel intrauterine system (LNG-IUS', '94 eligible women, 64 with abnormal bleeding associated with LNG-IUS']","['placebo', 'ulipristal acetate', 'ulipristal acetate (UPA']","['abnormal bleeding', 'mean number of bleeding days', 'Bleeding', 'shorter duration before bleeding stopped and longer time free of bleeding', 'number of days before bleeding stopped and days free of bleeding']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0042134', 'cui_str': 'Uterine Bleeding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4293467', 'cui_str': 'Levonorgestrel Intrauterine System [Liletta]'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2723461', 'cui_str': 'ulipristal acetate'}, {'cui': 'C0296939', 'cui_str': 'UP(5)A'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}]",94.0,0.468912,"For the 25 study participants, differences were nonsignificant between the UPA and placebo groups for number of days before bleeding stopped and days free of bleeding; however, UPA users displayed a trend for shorter duration before bleeding stopped and longer time free of bleeding.","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peloggia', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Baccaro', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Castro', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Nelsilene', 'Initials': 'N', 'LastName': 'Carvalho', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bahamondes', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medical Sciences, Family Planning Clinic, University of Campinas, Campinas, SP, Brazil.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13068']
791,31775999,The Treatment of Proximal Humerus Fracture Using Internal Fixation with Fixed-angle Plates.,"BACKGROUND


Implants made of various types of material can be used for the internal fixation of fractures. Carbon fiber reinforced polyetheretherketone (CFR-PEEK) is a radiolucent material that may have advantageous handling properties compared with titanium implants.
METHODS


Seventy-six patients with proximal humerus fractures requiring surgery were randomized to receive a fixed-angle plate made out of either titanium or CFR- PEEK. To measure the functional outcome, the DASH score (Disabilities of Arm, Shoulder, and Hand; primary endpoint), the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS) were determined in 63 patients at 6 weeks, 12 weeks, and 6 months after surgery, accompanied at each time point by radiological evaluation.
RESULTS


Both groups displayed improvement in DASH scores 6 months after surgery (CFR-PEEK: 27.5 ± 20.5; titanium: 28.5 ± 17.9; p = 0.82). Sensitivity analysis with multiple imputations confirmed this result (27.4 ± 19.2 versus 28.5 ± 16.6). The OSS and SST scores were likewise improved in both groups. All patients displayed full bony consolidation 12 weeks after surgery. In no case was material failure, secondary dislocation, or screw perforation seen. No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group.
CONCLUSION


The internal fixation of proximal humerus fractures with either CFR-PEEK or titanium led to clinical improvement 6 months after surgery. No clinical or radiological difference in outcomes was seen between the two groups. Because of the study design, however, the equivalence of the two interventions was not con- clusively demonstrated; a non-inferiority study would have been needed for this purpose.",2019,"No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group.
",['Seventy-six patients with proximal humerus fractures requiring surgery'],"['Carbon fiber reinforced polyetheretherketone (CFR-PEEK', 'titanium or CFR- PEEK', 'CFR-PEEK or titanium', 'Proximal Humerus Fracture Using Internal Fixation with Fixed-angle Plates']","['OSS and SST scores', 'DASH scores', 'postoperative reposition', 'functional outcome, the DASH score (Disabilities of Arm, Shoulder, and Hand; primary endpoint), the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS', 'material failure, secondary dislocation, or screw perforation seen']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020162', 'cui_str': 'Humeral Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0108411', 'cui_str': 'Carbon Felt'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C1305363', 'cui_str': 'Catalytic fraction'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020162', 'cui_str': 'Humeral Fractures'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]","[{'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]",76.0,0.0553761,"No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ziegler', 'Affiliation': 'BG Hospital Tübingen, University Clinic for Trauma and Reconstructive Surgery, University of Tübingen, Germany; Center for Musculoskeletal Surgery, Charité University Medical Center Berlin, Germany; Center for Bone and Joint Surgery, Kronprinzenbau Hospital, Reutlingen, Germany; BG Hospital Murnau, Murnau, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Maier', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stöckle', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gühring', 'Affiliation': ''}, {'ForeName': 'Fabian M', 'Initials': 'FM', 'LastName': 'Stuby', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0757']
792,30939480,Association of Acute Kidney Injury with Cardiovascular Events and Death in Systolic Blood Pressure Intervention Trial.,"RATIONALE AND OBJECTIVE


In the Systolic Blood Pressure Intervention Trial, the possible relationships between acute kidney injury (AKI) and risk of major cardiovascular events and death are not known.
STUDY DESIGN


Post hoc analysis of a multicenter, randomized, controlled, open-label clinical trial.
SETTING AND PARTICIPANTS


Hypertensive adults without diabetes who were ≥50 years of age with prior cardiovascular disease, chronic kidney disease (CKD), 10-year Framingham risk score > 15%, or age > 75 years were assigned to a systolic blood pressure target of < 120 mm Hg (intensive) or < 140 mm Hg (standard).
PREDICTOR


AKI episodes.
OUTCOMES


The primary outcome was a composite of myocardial infarction, acute coronary syndrome, stroke, decompensated heart failure, or cardiovascular death. The secondary outcome was death from any cause. Analytical Approach: AKI was defined using the Kidney Disease: Improving Global Outcomes modified criteria based solely upon serum creatinine. AKI episodes were identified by serious adverse events or emergency room visits. Cox proportional hazards models assessed the risk for the primary and secondary outcomes by AKI status.
RESULTS


Participants were 68 ± 9 years of age, 36% women (3,332/9,361), and 30% Black race (2,802/9,361), and 17% (1,562/9,361) with cardiovascular disease. Systolic blood pressure was 140 ± 16 mm Hg at study entry. AKI occurred in 4.4% (204/4,678) and 2.6% (120/4,683) in the intensive and standard treatment groups respectively (p < 0.001). Those who experienced AKI had higher risk of cardiovascular events (hazard ratio [HR] 1.52, 95% CI 1.05-2.20, p = 0.026) and death from any cause (HR 2.33, 95% CI 1.56-3.48, p < 0.001) controlling for age, sex, race, baseline systolic blood pressure, body mass index, number of antihypertensive medications, cardiovascular disease and CKD status, hypotensive episodes, and treatment assignment.
LIMITATIONS


The study was not prospectively designed to determine relationships between AKI, cardiovascular events, and death.
CONCLUSIONS


Among older adults with hypertension at high cardiovascular risk, intensive treatment of blood pressure independently increased risk of AKI, which substantially raised risks of major cardiovascular events and death.",2019,"Among older adults with hypertension at high cardiovascular risk, intensive treatment of blood pressure independently increased risk of AKI, which substantially raised risks of major cardiovascular events and death.","['Hypertensive adults without diabetes who were ≥50 years of age with prior cardiovascular disease, chronic kidney disease (CKD', 'Participants were 68 ± 9 years of age, 36% women (3,332/9,361), and 30% Black race (2,802/9,361), and 17% (1,562/9,361) with cardiovascular disease', 'older adults with hypertension at high cardiovascular risk', ' 75 years were assigned to a systolic blood pressure target of < 120 mm Hg (intensive) or < 140 mm Hg (standard', 'Kidney Disease']",[],"['AKI', 'composite of myocardial infarction, acute coronary syndrome, stroke, decompensated heart failure, or cardiovascular death', 'risk of cardiovascular events (hazard ratio [HR', 'death', 'death from any cause', 'AKI, cardiovascular events, and death', 'baseline systolic blood pressure, body mass index, number of antihypertensive medications, cardiovascular disease and CKD status, hypotensive episodes', 'Systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode (disorder)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.199332,"Among older adults with hypertension at high cardiovascular risk, intensive treatment of blood pressure independently increased risk of AKI, which substantially raised risks of major cardiovascular events and death.","[{'ForeName': 'Brad P', 'Initials': 'BP', 'LastName': 'Dieter', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA, braddieter@gmail.com.'}, {'ForeName': 'Kenn B', 'Initials': 'KB', 'LastName': 'Daratha', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA.'}, {'ForeName': 'Sterling M', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Short', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA.'}, {'ForeName': 'Radica Z', 'Initials': 'RZ', 'LastName': 'Alicic', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA.'}]",American journal of nephrology,['10.1159/000499574']
793,31200893,Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial.,"BACKGROUND


Paediatric vaccination against influenza can result in indirect protection, by reducing transmission to their unvaccinated contacts. We investigated whether influenza vaccination of children would protect them and their household members in a resource-limited setting.
METHODS


We did a cluster-randomised, blinded, controlled study in three villages in India. Clusters were defined as households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study. Households were randomly assigned (1:1) by a computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV) in the beginning of the study; vaccination occurred once a year for 3 years. The primary efficacy outcome was laboratory-confirmed influenza in a vaccinated child with febrile acute respiratory illness, analysed in the modified intention-to-treat population (ie, children who received at least one dose of vaccine, were under surveillance, and had not an influenza infection within 15 days of last vaccine dose). The secondary outcome for indirect effectiveness (surveillance study) was febrile acute respiratory illness in an unvaccinated household member of a vaccine study participant. Data from each year (year 1: November, 2009, to October, 2010; year 2: October, 2010, to October, 2011; and year 3: October, 2011, to May, 2012) were analysed separately. Safety was analysed among all participants who were vaccinated with at least one dose of the vaccine. This trial is registered with ClinicalTrials.gov, number NCT00934245.
FINDINGS


Between Nov 1, 2009, to May 1, 2012, we enrolled 3208 households, of which 1959 had vaccine-eligible children. 1010 households were assigned to IIV3 and 949 households were assigned to IPV. In 3 years, we vaccinated 4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10 813 unvaccinated household contacts. In year 1, influenza virus was detected in 151 (10%) of 1572 IIV3 recipients and 206 (13%) of 1633 of IPV recipients (total IIV3 vaccine efficacy 25·6% [95% CI 6·8-40·6]; p=0·010). In year 2, 105 (6%) of 1705 IIV3 recipients and 182 (10%) of 1814 IPV recipients had influenza (vaccine efficacy 41·0% [24·1-54·1]; p<0·0001). In year 3, 20 (1%) of 1670 IIV3 recipients and 81 (5%) of 1786 IPV recipients had influenza (vaccine efficacy 74·2% [57·8-84·3]; p<0·0001). In year 1, total vaccine efficacy against influenza A(H1N1)pdm09 was 14·5% (-20·4 to 39·3). In year 2, total vaccine efficacy against influenza A(H3N2) was 64·5% (48·5-75·5). Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3. Indirect vaccine effectiveness was statistically significant only in year 3 (38·1% [7·4-58·6], p=0·0197) when influenza was detected in 39 (1%) of 4323 IIV3-allocated and 60 (1%) of 4121 IPV-allocated household unvaccinated individuals. In the IIV3 group, 225 (12%) of 1632 children in year 1, 375 (22%) of 1718 in year 2, and 209 (12%) of 1673 in year 3 had an adverse reaction (compared with 216 [13%] of 1730, 380 [21%] of 1825, and 235 [13%] of 1796, respectively, in the IPV group). The most common reactions in both groups were fever and tenderness at site. No vaccine-related deaths occurred in either group.
INTERPRETATION


IIV3 provided variable direct and indirect protection against influenza infection. Indirect protection was significant during the year of highest direct protection and should be considered when quantifying the effect of vaccination programmes.
FUNDING


US Centers for Disease Control and Prevention.",2019,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","['1010 households were assigned to IIV3 and 949 households were assigned to', '4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10\u2008813 unvaccinated household contacts', 'enrolled 3208 households, of which 1959 had vaccine-eligible children', 'households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study', 'children would protect them and their household members in a resource-limited setting', 'rural India', 'participants who were vaccinated with at least one dose of the vaccine', 'three villages in India']","['inactivated trivalent influenza vaccine', 'IPV', 'computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV']","['Efficacy', 'Indirect vaccine effectiveness', 'febrile acute respiratory illness', 'Total vaccine efficacy', 'total vaccine efficacy', 'deaths', 'Safety', 'adverse reaction']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C0770694'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",3208.0,0.452958,"Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3.","[{'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Sullender', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Center for Global Health, School of Public Health, University of Colorado Denver, Denver, CO, USA. Electronic address: wayne.sullender@ucdenver.edu.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Community Ophthalmology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Debjani', 'Initials': 'D', 'LastName': 'Ram Purakayastha', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Raghuram', 'Initials': 'R', 'LastName': 'Srungaram Vln', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Palomeque', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gargiullo', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Broor', 'Affiliation': 'Microbiology Department, All India Institute of Medical Sciences, Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30079-8']
794,31773444,"Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data.","In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with antiretroviral therapy adherence (≥ 95% adherent), viral suppression (HIV RNA < 75 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA ≥ 75 copies/mL plus condomless sex). The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA < 75 copies/mL) who completed baseline, 6-, and 12-month assessments. Decrease in days of unhealthy drinking was associated with increased likelihood of viral suppression (odds ratio [OR] 3.78; 95% confidence interval [CI] 1.06, 13.51, P = .04) versus no change. Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001). Neither increase nor decrease were associated with adherence or dual-risk outcome. On a continuous scale, for each increase by 1 day of unhealthy drinking in the prior month, the odds of being 95% adherent decreased by 6% (OR 0.94, 95% CI 0.88, 1.00, P = 0.04).",2020,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","['for women/men) with antiretroviral therapy adherence (≥\u200995% adherent), viral suppression (HIV RNA\u2009<\u200975 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA\u2009≥\u200975 copies/mL plus condomless sex', 'The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA\u2009<\u200975 copies/mL) who completed baseline, 6-, and 12-month assessments', 'people with HIV (PWH']",['unhealthy drinking (consuming\u2009≥\u20094/≥\u20095 drinks'],"['adherence or dual-risk outcome', 'likelihood of viral suppression', 'Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex', 'likelihood of condomless sex']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",566.0,0.042416,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Varada', 'Initials': 'V', 'LastName': 'Sarovar', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA.'}, {'ForeName': 'J Carlo', 'Initials': 'JC', 'LastName': 'Hojilla', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02742-y']
795,31543373,Addition of marine omega-3 fatty acids to statins in familial hypercholesterolemia does not affect in vivo or in vitro endothelial function.,"BACKGROUND


Prestatin trials reported positive effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) in cardiovascular disease, whereas recent studies and meta-analyses have not reproduced these results. The effect of n-3 PUFA in patients with familial hypercholesterolemia (FH), a group with particularly high risk of cardiovascular disease, is not well established.
OBJECTIVE


We investigated the effect of n-3 PUFA in the early stage of atherosclerosis in FH patients by evaluating in vivo (peripheral arterial tonometry [PAT]) and in vitro (plasma asymmetric dimethylarginine and E-selectin) endothelial function.
METHODS


This was a double-blind, placebo-controlled cross-over study with 34 FH patients on statin treatment (mean age 46.6 years). In random order, all individuals were treated for 3 months with high-dose n-3 PUFA (2 g, ×2) and 3 months placebo (olive oil, 2 g ×2), separated by a 3-month washout period. Anthropometric data, blood samples, and PAT were collected at 4 time points.
RESULTS


There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51). No significant changes were detected in the soluble endothelial marker asymmetric dimethylarginine (in 2 different assays) when comparing n-3 PUFA and placebo (P = .92 and .14, respectively). Finally, the level of E-selectin did not change significantly during the trial (P = .26).
CONCLUSION


Addition of n-3 PUFA to standard lipid-lowering treatment in genetically verified FH patients did not affect the in vivo endothelial function or soluble endothelial markers.",2019,"There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51).","['34 FH patients on statin treatment (mean age 46.6\xa0years', 'FH patients by evaluating in\xa0vivo', 'patients with familial hypercholesterolemia (FH), a group with particularly high risk of cardiovascular disease']","['peripheral arterial tonometry [PAT', 'n-3 PUFA and placebo', 'marine omega-3 fatty acids', 'placebo', 'n-3 PUFA', 'omega-3 polyunsaturated fatty acids (n-3 PUFA', 'placebo (olive oil']","['reactive hyperemia index', 'Anthropometric data, blood samples, and PAT', 'median reactive hyperemia index after n-3 PUFA', 'soluble endothelial marker asymmetric dimethylarginine', 'level of E-selectin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}]",,0.34091,"There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51).","[{'ForeName': 'Liv Nesse', 'Initials': 'LN', 'LastName': 'Hande', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Faculty of Health Sciences, University of Tromsø, Tromsø, Norway. Electronic address: livnessehande@gmail.com.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Thunhaug', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Enebakk', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Ludviksen', 'Affiliation': 'Research Laboratory, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pettersen', 'Affiliation': 'Research Laboratory, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hovland', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Knut Tore', 'Initials': 'KT', 'LastName': 'Lappegård', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.08.004']
796,31387097,"Iron Regulation by Molidustat, a Daily Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor, in Patients with Chronic Kidney Disease.","BACKGROUND/AIMS


The current treatment for anemia associated with chronic kidney disease (CKD) includes the administration of erythropoiesis stimulating agents (ESAs) combined with iron supplementation. Molidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, has potential to treat anemia associated with CKD through increased erythropoietin production and improved iron availability. Here, we report the effect of molidustat on iron metabolism.
METHOD


Parameters of iron metabolism were monitored in three 16-week, randomized, controlled, phase 2 studies assessing the safety and efficacy of molidustat in the treatment of anemia associated with CKD in different populations: treatment-naïve and previously ESA-treated patients not on dialysis, and previously ESA-treated patients on hemodialysis. Iron supplementation was left at the discretion of the investigator.
RESULTS


In treatment-naïve patients not on dialysis, transferrin saturation (TSAT), hepcidin, ferritin, and iron concentrations decreased with molidustat, whereas total iron binding capacity (TIBC) increased. Similar results were observed in previously ESA-treated patients not on dialysis, although changes in those parameters were larger in treatment-naïve than in previously ESA-treated patients. In previously ESA-treated patients receiving hemodialysis, hepcidin concentration and TIBC remained stable with molidustat, whereas TSAT and ferritin and iron concentrations increased. Generally, similar trends were observed in secondary analyses of subgroups of patients not receiving iron supplementation.
CONCLUSIONS


Molidustat is a potential alternative to standard treatment of anemia associated with CKD, with a different mechanism of action. In patients not receiving dialysis, molidustat increases iron availability. In patients receiving hemodialysis, further investigation is required to understand fully the mechanisms underlying iron mobilization associated with molidustat.",2019,"In treatment-naïve patients not on dialysis, transferrin saturation (TSAT), hepcidin, ferritin, and iron concentrations decreased with molidustat, whereas total iron binding capacity (TIBC) increased.","['anemia associated with chronic kidney disease (CKD', 'Patients with Chronic Kidney Disease']","['ESA-treated patients not on dialysis, and previously ESA-treated patients on hemodialysis', 'erythropoiesis stimulating agents (ESAs) combined with iron supplementation', 'Iron Regulation by Molidustat, a Daily Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor']","['TSAT and ferritin and iron concentrations', 'dialysis, transferrin saturation (TSAT), hepcidin, ferritin, and iron concentrations', 'iron availability', 'total iron binding capacity (TIBC', 'safety and efficacy']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C4078705', 'cui_str': 'molidustat'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3658210', 'cui_str': 'Proline Dioxygenase Inhibitors'}]","[{'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036835', 'cui_str': 'TIBC'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0144246,"In treatment-naïve patients not on dialysis, transferrin saturation (TSAT), hepcidin, ferritin, and iron concentrations decreased with molidustat, whereas total iron binding capacity (TIBC) increased.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan, akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berns', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Taguchi', 'Affiliation': 'Bayer Yakuhin Ltd., Osaka, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Iekushi', 'Affiliation': 'Bayer Yakuhin Ltd., Osaka, Japan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bernhardt', 'Affiliation': 'Bayer Pharma AG, Berlin, Germany.'}]",Nephron,['10.1159/000502012']
797,31770574,Effects of Shenfu injection on survival and neurological outcome after out-of-hospital cardiac arrest: A randomised controlled trial.,"AIM


We aimed to assess the effects of Shenfu injection (SFI) in combination with epinephrine during cardiac arrest on survival and neurological outcome after out-of-hospital cardiac arrest (OHCA).
METHODS


In this randomised, assessor-blind controlled trial, Utstein-style data were collected from 1233 OHCA patients treated at the Beijing Emergency Medical Center between January 2013 and June 2016. The patients were randomised into either a treatment group that received a combination of SFI and standard treatment with epinephrine or a control group that received standard treatment with epinephrine alone. The primary outcome was survival to hospital admission. The secondary outcomes were return of spontaneous circulation (ROSC), survival to hospital discharge, favourable neurological outcome at discharge, survival to one year, and favourable neurological outcome at one-year survival.
RESULTS


In both groups, the survival to hospital admission, ROSC, survival to hospital discharge, and one-year survival rate after discharge from the hospital did not differ significantly. However, SFI achieved favourable neurological outcome at discharge in comparison with the standard treatment with an odds ratio (OR) of 2.72 at a 95% confidence interval (CI; 1.00-8.53). Meanwhile, unlike with epinephrine alone, the combination of SFI and epinephrine achieved a better cerebral performance category (CPC) score (1-2) after one-year survival (OR: 5.08, 95% CI: 1.07-47.80).
CONCLUSION


The combination of SFI and epinephrine had favourable neurological outcomes after OHCA compared with those with epinephrine alone, whereas the survival to admission was not significantly altered.",2020,"In both groups, the survival to hospital admission, ROSC, survival to hospital discharge, and one-year survival rate after discharge from the hospital did not differ significantly.","['after Out-of-Hospital Cardiac Arrest', '1233 OHCA patients treated at the Beijing Emergency Medical Center between January 2013 and June 2016']","['Shenfu Injection', 'epinephrine alone', 'SFI and epinephrine', 'SFI and standard treatment with epinephrine', 'epinephrine', 'Shenfu injection (SFI']","['Survival and Neurological Outcome', 'survival to admission', 'survival to hospital admission', 'cerebral performance category (CPC) score', 'survival to hospital admission, ROSC, survival to hospital discharge, and one-year survival rate', 'favourable neurological outcomes', 'return of spontaneous circulation (ROSC), survival to hospital discharge, favourable neurological outcome at discharge, survival to one year, and favourable neurological outcome at one-year survival', 'survival and neurological outcome', 'favourable neurological outcome']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]",,0.353074,"In both groups, the survival to hospital admission, ROSC, survival to hospital discharge, and one-year survival rate after discharge from the hospital did not differ significantly.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Beijing Emergency Medical Center, Beijing, China.'}, {'ForeName': 'Chunsheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. Electronic address: lcscyyy@163.com.'}]",Resuscitation,['10.1016/j.resuscitation.2019.11.010']
798,31377052,"Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies.","BACKGROUND


Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease.
OBJECTIVE


We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status.
METHODS


Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24-104 weeks' duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non-familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75 mg every 2 weeks (Q2W) to 150 mg Q2W at Week 12 if predefined risk-based LDL-C goals were not achieved at Week 8 (≥70 mg/dL in very high cardiovascular risk; ≥100 mg/dL in moderate or high cardiovascular risk). Two trials compared alirocumab 150 mg Q2W vs placebo. The efficacy and safety of alirocumab were assessed post hoc in subgroups stratified by age (<65, ≥65 to <75, ≥75 years) and baseline hypertension or smoking status.
RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control. Subgroup analyses confirmed no significant interactions in response to alirocumab between age group, hypertension, or smoking status. Overall rates of treatment-emergent adverse events were similar between alirocumab and control groups.
CONCLUSIONS


In this pooled analysis from 10 trials, alirocumab led to substantial LDL-C reductions vs control in every age group and regardless of hypertension or smoking status. Alirocumab was well tolerated in all subgroups.",2019,"RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control.","[""Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24-104\xa0weeks' duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non-familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on"", 'subgroups stratified by age (<65, ≥65 to <75, ≥75\xa0years) and baseline hypertension or smoking status']","['alirocumab 150\xa0mg Q2W vs placebo', 'ezetimibe and 1175 on placebo', 'alirocumab', 'Alirocumab']","['LDL-C', 'hypertension, or smoking status', 'efficacy and safety of alirocumab', 'Overall rates of treatment-emergent adverse events', 'low-density lipoprotein cholesterol (LDL-C', 'substantial LDL-C reductions', 'tolerated']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.155133,"RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control.","[{'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. Electronic address: Frederick.raal@wits.ac.za.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Cardiology Division, State University of Campinas School of Medicine (FCM Unicamp), Campinas, Brazil.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Fonseca', 'Affiliation': 'Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Averna', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE), School of Medicine, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farnier', 'Affiliation': 'Department of Cardiology, Lipid Clinic, Point Médical, CHU Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Ferdinand', 'Affiliation': 'Department of Medicine, Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': 'Department of Cardiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Eliano Pio', 'Initials': 'EP', 'LastName': 'Navarese', 'Affiliation': 'Interventional Cardiology and Cardiovascular Medicine Research, Mater Dei Hospital, Bari, Italy; Cardiovascular Institute, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland; SIRIO MEDICINE Network, VA, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Lerch', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'L Veronica', 'Initials': 'LV', 'LastName': 'Lee', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Biostatistics and Programming, Chilly-Mazarin, France.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.06.006']
799,31768618,"The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects.","Suprahyoid muscle activation and tongue pressure force play a critical role for swallowing function. In addition, dysphagia limit is one of most important factors indicating swallowing efficiency. The purpose of this study was to compare the effects of 8-week training sessions of three different exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband on suprahyoid muscle activity, anterior tongue pressure and dysphagia limit in healthy subjects. Thirty-six healthy volunteers aged between 18 and 40 years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10) were included in the study, and all participants were divided into three groups randomly. Maximal suprahyoid muscle activations and dysphagia limit of participants were assessed by superficial electromyography. CTAR and chin tuck exercise with theraband increased the maximum suprahyoid muscle activation (p 1  = 0.004, p 2  = 0.018), whereas Shaker exercise did not increase maximal suprahyoid muscle activation (p = 0.507) after exercise training. CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248). There was no statistically significant difference in dysphagia limits in three groups between before and after exercise training (p > 0.05). As a result, although CTAR seems to be the most effective exercise in most parameters, chin tuck exercise with theraband can also be used as an alternative to CTAR to improve suprahyoid muscle activity and tongue pressure.",2020,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","['Healthy Subjects', 'healthy subjects', 'Thirty-six healthy volunteers aged between 18 and 40\xa0years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10']","['Different Exercise Trainings', 'exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband']","['Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit', 'maximal suprahyoid muscle activation', 'Maximal suprahyoid muscle activations and dysphagia limit', 'suprahyoid muscle activity, anterior tongue pressure and dysphagia limit', 'tongue pressure', 'anterior tongue pressure', 'dysphagia limits', 'maximum suprahyoid muscle activation', 'CTAR and chin tuck exercise']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0226945', 'cui_str': 'Structure of body of tongue'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",36.0,0.0123338,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","[{'ForeName': 'Hasan Erkan', 'Initials': 'HE', 'LastName': 'Kılınç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Sogutozu, Ankara, 06510, Turkey. erkankilinc86@hotmail.com.'}, {'ForeName': 'Selen Serel', 'Initials': 'SS', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Karaduman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",Dysphagia,['10.1007/s00455-019-10079-w']
800,31774402,User Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


The success of a mobile phone app in changing health behavior is thought to be contingent on engagement, commonly operationalized as frequency of use.
OBJECTIVE


This subgroup analysis of the 2 intervention arms from a 3-group randomized controlled trial aimed to examine user engagement with a 100-day physical activity intervention delivered via an app. Rates of engagement, associations between user characteristics and engagement, and whether engagement was related to intervention efficacy were examined.
METHODS


Engagement was captured in a real-time log of interactions by users randomized to either a gamified (n=141) or nongamified version of the same app (n=160). Physical activity was assessed via accelerometry and self-report at baseline and 3-month follow-up. Survival analysis was used to assess time to nonuse attrition. Mixed models examined associations between user characteristics and engagement (total app use). Characteristics of super users (top quartile of users) and regular users (lowest 3 quartiles) were compared using t tests and a chi-square analysis. Linear mixed models were used to assess whether being a super user was related to change in physical activity over time.
RESULTS


Engagement was high. Attrition (30 days of nonuse) occurred in 32% and 39% of the gamified and basic groups, respectively, with no significant between-group differences in time to attrition (P=.17). Users with a body mass index (BMI) in the healthy range had higher total app use (mean 230.5, 95% CI 190.6-270.5; F 2 =8.67; P<.001), compared with users whose BMI was overweight or obese (mean 170.6, 95% CI 139.5-201.6; mean 132.9, 95% CI 104.8-161.0). Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6). Super users were 4.6 years older (t 297 =3.6; P<.001) and less likely to have a BMI in the obese range (χ 2 2 =15.1; P<.001). At the 3-month follow-up, super users were completing 28.2 (95% CI 9.4-46.9) more minutes of objectively measured physical activity than regular users (F 1,272 =4.76; P=.03).
CONCLUSIONS


Total app use was high across the 100-day intervention period, and the inclusion of gamified features enhanced engagement. Participants who engaged the most saw significantly greater increases to their objectively measured physical activity over time, supporting the theory that intervention exposure is linked to efficacy. Further research is needed to determine whether these findings are replicated in other app-based interventions, including those experimentally evaluating engagement and those conducted in real-world settings.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000113358; https://www.anzctr.org.au/ACTRN12617000113358.aspx.",2019,"Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6).",[],['100-day physical activity intervention delivered via an app'],"['Physical activity', 'Attrition', 'time to attrition', 'physical activity']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.325785,"Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F 1 =6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Edney', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Ryan', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Adelaide, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Olds', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Monroe', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Fraysse', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, School of Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Curtis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, Australia.'}]",Journal of medical Internet research,['10.2196/14645']
801,31100620,Effects of dietary intervention and n-3 PUFA supplementation on markers of gut-related inflammation and their association with cardiovascular events in a high-risk population.,"BACKGROUND & AIMS


Dysbiosis of the gut microbiota is associated with increased levels of circulating lipopolysaccharide (LPS) and subsequent activation of systemic inflammation. Diet is an important modulator of the gut microbiome. We aimed to investigate whether circulating markers of gut-related inflammation, LPS binding protein (LBP) and soluble CD14 (sCD14) can be modulated by n-3 PUFA supplementation and/or diet counselling, and whether these markers are related to cardiovascular (CV) outcome.
METHODS


484 men aged 65-75 years, at high CV-risk, were included and randomized in a 2 × 2 factorial design to 36-month intervention with dietary counselling, n-3 PUFA supplementation, or both. N-3 PUFA supplementation was placebo-controlled. ELISAs were used for determination of the biomarkers measured at baseline and study-end. A composite endpoint was defined as new CV-events and CV-mortality after 36 months.
RESULTS


There were no significant differences in changes of either LBP or sCD14 in the intervention groups compared to their respective controls (n-3 PUFA vs. placebo: p = 0.58, p = 0.15, diet vs. no-diet: p = 0.53, p = 0.59, respectively). The group with LBP levels above median had about 2-fold unadjusted risk of suffering an endpoint compared to the group below (HR 2.22, 95% CI 1.25-3.96; p = 0.01). A similar tendency was seen for sCD14 (HR 1.72, 95% CI 0.97-3.03; p = 0.06). After adjusting for covariates, LBP remained significantly associated with a two-fold CV-risk, whereas sCD14 gained statistical significance, however, lost when hsCRP was added to the model.
CONCLUSIONS


In our population, markers of gut-related inflammation associated with 36-month CV outcome. However, neither n-3 PUFA nor diet intervention had an effect on these markers.",2019,"There were no significant differences in changes of either LBP or sCD14 in the intervention groups compared to their respective controls (n-3 PUFA vs. placebo: p = 0.58, p = 0.15, diet vs. no-diet: p = 0.53, p = 0.59, respectively).","['484 men aged 65-75 years, at high CV-risk']","['PUFA supplementation', 'placebo', 'dietary intervention and n-3 PUFA supplementation', 'n-3 PUFA nor diet intervention', 'dietary counselling, n-3 PUFA supplementation, or both. N-3']","['new CV-events and CV-mortality', 'LBP or sCD14']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",484.0,0.0886943,"There were no significant differences in changes of either LBP or sCD14 in the intervention groups compared to their respective controls (n-3 PUFA vs. placebo: p = 0.58, p = 0.15, diet vs. no-diet: p = 0.53, p = 0.59, respectively).","[{'ForeName': 'Ayodeji', 'Initials': 'A', 'LastName': 'Awoyemi', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Center for Heart Failure Research, Oslo University Hospital, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, P.O. Box 1171 Blindern, 0318, Oslo, Norway. Electronic address: a.o.awoyemi@medisin.uio.no.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, P.O. Box 4950 Nydalen, N-0424, Oslo, Norway; Section of Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, P.O. Box 4950 Nydalen, N-0424, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, P.O. Box 1171 Blindern, 0318, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Center for Heart Failure Research, Oslo University Hospital, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, P.O. Box 1171 Blindern, 0318, Oslo, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Center for Heart Failure Research, Oslo University Hospital, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Center for Heart Failure Research, Oslo University Hospital, P.O. Box 4956 Nydalen, N-0424, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, P.O. Box 1171 Blindern, 0318, Oslo, Norway.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.05.004']
802,31192515,Masseter corticomotor excitability is decreased after intramuscular administration of nerve growth factor.,"BACKGROUND


Quantification of motor-evoked potentials (MEPs) can contribute to better elucidate the central modulation of motor pathways in response to nociceptive inputs. The primary aim of this study was to assess the modulatory effects of nerve growth factor (NGF) injection on masseter corticomotor excitability.
METHODS


The healthy participants of this randomized, double blind placebo-controlled experiment were assigned to have injected into the right masseter muscle either NGF (n = 25) or isotonic saline (IS, n = 17). The following variables were assessed at baseline and 48 hr after the injection: right masseter MEP amplitude and corticomotor mapping and clinical assessment of jaw pain intensity and function. Repeated Measures ANOVA was applied to the data.
RESULTS


NGF caused jaw pain and increased jaw functional disability after the injection (p < 0.050). Also, the participants in the NGF group decreased the MEP amplitude (p < 0.001) but the IS group did not present any significant modulation after the injection (p > 0.050). Likewise, the participants in the NGF group reduced corticomotor map area and volume (p < 0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p > 0.050). Finally, there was a significant correlation between the magnitude of decreased corticomotor excitability and jaw pain intensity on chewing 48 hr after the NGF injection (r = -0.51, p = 0.009).
CONCLUSION


NGF-induced masseter muscle soreness can significantly reduce jaw muscle corticomotor excitability, which in turn is associated with lower jaw pain intensity and substantiates the occurrence of central changes that most likely aim to protect the musculoskeletal orofacial structures.
SIGNIFICANCE


Intramuscular administration of nerve growth factor into masseter muscle causes inhibitory corticomotor plasticity, which likely occurs to prevent further damage and seems associated with lower pain intensity on function.",2019,"Likewise, the participants in the NGF group reduced corticomotor map area and volume (p<0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p>0.050).",['healthy participants'],"['NGF-induced masseter muscle soreness', 'placebo', 'isotonic saline', 'NGF', 'motor-evoked potentials (MEPs', 'nerve growth factor (NGF) injection']","['jaw pain and increased jaw functional disability', 'MEP amplitude', 'right masseter MEP amplitude and corticomotor mapping and clinical assessment of jaw pain intensity and function', 'Masseter corticomotor excitability', 'corticomotor excitability and jaw pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0024876', 'cui_str': 'Masseter Muscle'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0236000', 'cui_str': 'Jaw pain (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",,0.209691,"Likewise, the participants in the NGF group reduced corticomotor map area and volume (p<0.001), but the IS group did not show any significant corticomotor mapping changes after the injection (p>0.050).","[{'ForeName': 'Yuri M', 'Initials': 'YM', 'LastName': 'Costa', 'Affiliation': 'Department of Physiological Sciences, Piracicaba Dental School, University of Campinas, Piracicaba, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Scandinavian Center for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Castrillon', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Paulo César R', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1438']
803,31099799,CVAD Homecare Management: Investigating the Use of a Digital Education Tool During Nurse-Delivered Instruction to Parents for New Central Lines in Children With Cancer.,"BACKGROUND


Research on parent understanding of homecare management of external central venous access devices (CVADs) for children with cancer is limited.
OBJECTIVES


The goal was to investigate whether the use of a DVD education intervention reduced adverse complications and improved parent education for homecare management of CVADs for pediatric patients with cancer.
METHODS


Participants were randomized to an experimental group (DVD and nurse teaching) or a control group (nurse teaching). Postintervention evaluation included parent satisfaction and CVAD knowledge proficiency, blood infection rates, use of alteplase, and CVAD replacement.
FINDINGS


Fifty-four enrolled caregiver-patient dyads completed the study measures, with 21 dyads assigned to the control group and 33 assigned to the experimental group. Alteplase was ordered significantly less often in the experimental group. No other findings were significant.",2019,Alteplase was ordered significantly less often in the experimental group.,"['Children With Cancer', 'Fifty-four enrolled caregiver-patient dyads', 'children with cancer', 'pediatric patients with cancer', 'Participants']","['Digital Education Tool', 'DVD education intervention', 'external central venous access devices (CVADs', 'experimental group (DVD and nurse teaching) or a control group (nurse teaching']","['adverse complications', 'parent satisfaction and CVAD knowledge proficiency, blood infection rates, use of alteplase, and CVAD replacement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015538', 'cui_str': 'Faculty, Nursing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0005768'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",54.0,0.0361461,Alteplase was ordered significantly less often in the experimental group.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Raybin', 'Affiliation': ""Children's Hospital Colorado.""}, {'ForeName': 'Suhong', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'King', 'Affiliation': ""Children's Hospital Colorado.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Simms', 'Affiliation': ""Children's Hospital Colorado.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Giller', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Montgomery', 'Affiliation': ""American Family Children's Hospital.""}, {'ForeName': 'Verna L', 'Initials': 'VL', 'LastName': 'Hendricks-Ferguson', 'Affiliation': 'Saint Louis University.'}]",Clinical journal of oncology nursing,['10.1188/19.CJON.295-300']
804,31176888,Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder.,"BACKGROUND


Evidence-based treatments for posttraumatic stress disorder (PTSD) are associated with reduction in suicidal ideation (SI), yet the mechanisms underlying this reduction are unclear. The current study investigated improvements in PTSD, depression, and social support as potential mediators of the change in SI over time.
METHOD


Participants (N = 200) were active duty military personnel with PTSD randomized to prolonged exposure therapy (PE) or present-centered therapy (PCT). Using parallel mediation and serial mediation models, we examined the relative influence of the mediators on suicidal ideation over time.
RESULTS


Consistent with our hypotheses, lagged mediation analyses revealed that depression was the strongest mediator of improvements in SI over time in PE and PCT. Reductions in PTSD were associated with subsequent reductions in depression, which was associated with reductions in SI. Treatment condition did not moderate this relationship, and social support was not a significant mediator.
CONCLUSIONS


In active duty military personnel, reduction in depression was the strongest mediator of reduction in suicidal ideation in PE and PCT for PTSD. These results were not altered by treatment condition.
TRIAL REGISTRATION


Clinicaltrials. gov identifier: NCT01049516. http://www.clinicaltrials.gov/show/NCT01049516.",2019,"In active duty military personnel, reduction in depression was the strongest mediator of reduction in suicidal ideation in PE and PCT for PTSD.","['Participants (N\u202f=\u202f200) were active duty military personnel with PTSD randomized to', 'posttraumatic stress disorder (PTSD', 'posttraumatic stress disorder']",['prolonged exposure therapy (PE) or present-centered therapy (PCT'],"['SI', 'suicidal ideation over time']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",200.0,0.0591225,"In active duty military personnel, reduction in depression was the strongest mediator of reduction in suicidal ideation in PE and PCT for PTSD.","[{'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: lilybr@upenn.edu.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: yinyinz@upenn.edu.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Benhamou', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: ksb91@case.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX, United States. Electronic address: Daniel.Taylor@unt.edu.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, University of Utah, Salt Lake City, UT, United States; Department of Psychology, University of Utah, Salt Lake City, UT, United States. Electronic address: craig.bryan@utah.edu.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Department of Behavioral Medicine, Carl R. Darnall Army Medical Center, Fort Hood, TX, United States. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, Boston, MA, United States; Department of Psychiatry, Boston University School of Medicine, Boston, MA, United States; Department of Psychological and Brain Sciences, Boston University, Boston, MA, United States. Electronic address: Brett.Litz@va.gov.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: mintz@uthscsa.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: roache@uthscsa.edu.'}, {'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: Pruiksma@uthscsa.edu.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: Fina@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States; Research and Development Service, South Texas Veterans Health Care System, San Antonio, TX, United States; Department of Psychology, University of Texas at San Antonio, San Antonio, TX, United States. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: foa@pennmedicine.upenn.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Behaviour research and therapy,['10.1016/j.brat.2019.103409']
805,31178009,Efficacy of a Home-Based Parent Training-Focused Weight Management Intervention for Preschool Children: The DRIVE Randomized Controlled Pilot Trial.,"OBJECTIVES


To pilot-test a home-based parent training intervention aimed at maintaining body weight among children at risk for obesity (> the 75th body mass index percentile).
METHODS


Sixteen parent-child dyads were randomized to a health education or Developing Relationships that Include Values of Eating and Exercise (DRIVE) intervention arm. The DRIVE curriculum was a structured parenting program to promote healthy weight in children by relying on behavioral principles to promote skill acquisition in the family's natural setting. Body weight and waist circumference were measured at baseline and weeks 9 and 19.
RESULTS


Body mass index z-score, body weight, and percent body weight increased in children in the health education arm vs DRIVE at weeks 9 and 19. Body weight, percent body weight, and waist circumference decreased in parents in DRIVE vs the health education arm at week 19, whereas no differences were shown at week 9.
CONCLUSIONS AND IMPLICATIONS


The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents. Home-based interventions emphasizing parent-child interactions are indicated as a practical model to deliver weight management in children.",2019,The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents.,"['children', 'children at risk for obesity (> the 75th body mass index percentile', 'Sixteen parent-child dyads', 'Preschool Children']","['Home-Based Parent Training-Focused Weight Management Intervention', 'home-based parent training intervention', 'health education or Developing Relationships that Include Values of Eating and Exercise (DRIVE) intervention arm']","['Body mass index z-score, body weight, and percent body weight', 'weight gain', 'Body weight and waist circumference', 'Body weight, percent body weight, and waist circumference']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.0378361,The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents.,"[{'ForeName': 'Keely R', 'Initials': 'KR', 'LastName': 'Hawkins', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'Jenelle R', 'Initials': 'JR', 'LastName': 'Shanley', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA. Electronic address: Corby.martin@pbrc.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.002']
806,31763933,Pathways to Recovery among Homeless People with Mental Illness: Is Impulsiveness Getting in the Way?,"OBJECTIVE


This study investigates the association between impulsiveness and six dimensions of recovery among homeless people with mental illness.
METHOD


The sample was composed of 418 participants of a randomized controlled trial of Housing First, a recovery-oriented program that provides immediate access to permanent housing. The reliable change index method was used to provide an estimate of the statistical and clinical significance of the change from baseline to 24 months (i.e., clinically meaningful improvement), on outcomes that pertain to recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential). We tested for the effect of impulsiveness, assessed with the Barratt Impulsiveness Scale-11, on clinically meaningful improvement on each specific outcome, adjusting for age, gender and intervention assignment, as both intervention arms were included in the analysis.
RESULTS


For every increase in total impulsiveness score by one standard deviation, the odds of experiencing clinically meaningful improvement decreased by 29% ( OR  = 0.71, 95% CI, 0.55 to 0.91) on the clinical dimension and by 53% ( OR  = 0.47, 95% CI, 0.32 to 0.68) on the existential dimension. However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
CONCLUSIONS


Findings highlight the importance of addressing impulsiveness in the context of recovery-oriented interventions for homeless people with mental illness. Further research may be required to improve interventions that are responsive to unique needs of impulsive individuals to support clinical and existential recovery.",2020,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
","['418 participants', 'homeless people with mental illness', 'Homeless People with Mental Illness']",[],"['recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential', 'physical, functional, criminological, and social dimensions', 'total impulsiveness score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",418.0,0.0674948,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness.
","[{'ForeName': 'Marichelle C', 'Initials': 'MC', 'LastName': 'Leclair', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Lemieux', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roy', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719885477']
807,31763982,Influence of final kissing balloon inflation on long-term outcomes after PCI of distal left main bifurcation lesions in the EXCEL trial.,"AIMS


The impact of final kissing balloon inflation (FKBI) after percutaneous coronary intervention (PCI) of bifurcation lesions on long-term clinical outcomes remains controversial. We sought to determine the impact of FKBI on four-year outcomes after PCI of distal left main (LM) bifurcation lesions.
METHODS AND RESULTS


The EXCEL trial compared PCI with everolimus-eluting stents and coronary artery bypass graft surgery (CABG) in patients with left main (LM) disease. We examined four-year clinical outcomes after PCI of distal LM bifurcation lesions according to use of FKBI. The primary endpoint was the composite rate of death, myocardial infarction (MI), or stroke. The major secondary endpoint was the composite rate of death, MI, stroke, or ischaemia-driven revascularisation (IDR). Among 948 patients randomised to PCI, 759 had distal LM lesions treated, 430 of which were treated with one stent and 329 of which were treated with two or more stents. The four-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the one-stent and ≥2-stent groups in both unadjusted and adjusted analyses.
CONCLUSIONS


In the EXCEL trial, the performance of FKBI after PCI of distal LM bifurcation lesions was not associated with improved four-year clinical outcomes regardless of whether one stent or ≥2 stents were implanted.",2020,"The 4-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the 1-stent and ≥2-stent groups in both unadjusted and adjusted analyses.
","['948 patients randomized to PCI, 759 had distal LM lesions treated, 430 of which were treated with 1 stent and 329 of which were treated with 2 or more stents', 'patients with LM disease']","['FKBI', 'everolimus-eluting stents and coronary artery bypass graft surgery', 'Final Kissing Balloon Inflation']","['composite rate of death, myocardial infarction (MI), or stroke', 'composite rate of death, MI, stroke, or ischemia-driven revascularization (IDR', '4-year rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",948.0,0.165677,"The 4-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the 1-stent and ≥2-stent groups in both unadjusted and adjusted analyses.
","[{'ForeName': 'Annapoorna S', 'Initials': 'AS', 'LastName': 'Kini', 'Affiliation': 'Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': ''}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': ''}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Vengrenyuk', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': ''}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': ''}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': ''}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': ''}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ''}, {'ForeName': 'Samin K', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00851']
808,27148633,Personalized boosters for a computerized intervention targeting college drinking: The influence of protective behavioral strategies.,"OBJECTIVE


Computerized interventions are cost-effective and can quickly deliver individual feedback to many students. However, in-person interventions are more efficacious. The current study sought to improve the efficacy of a popular online intervention via e-mailed boosters with personalized feedback.
PARTICIPANTS


Participants were 213 student drinkers at a southeastern public university, ages 18-24.
METHODS


Students were randomized into (1) intervention only, or (2) intervention plus booster. Alcohol consumption and related problems were assessed at baseline, 2 weeks post, and 4 weeks post.
RESULTS


Boosters yielded reductions in drinking, but not alcohol-related problems. Boosters were associated with significant reductions for drinking frequency, heavy drinking days, peak drinks, and associated blood alcohol concentration (BAC). Protective behavioral strategies (PBS) moderated this effect, with significant reductions for students low in PBS, but not students already highly engaged in PBS use.
CONCLUSIONS


Easy dissemination and low cost make e-mailed boosters a very efficient way to promote student health.",2016,"Boosters were associated with significant reductions for drinking frequency, heavy drinking days, peak drinks, and associated blood alcohol concentration (BAC).","['Participants were 213 student drinkers at a southeastern public university, ages 18-24', 'Students', 'college drinking']","['Protective behavioral strategies (PBS', 'popular online intervention via e-mailed boosters with personalized feedback']","['drinking frequency, heavy drinking days, peak drinks, and associated blood alcohol concentration (BAC', 'Alcohol consumption and related problems']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4042862', 'cui_str': 'University Student Drinking'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",213.0,0.0339853,"Boosters were associated with significant reductions for drinking frequency, heavy drinking days, peak drinks, and associated blood alcohol concentration (BAC).","[{'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Braitman', 'Affiliation': 'a Department of Psychology , Old Dominion University , Norfolk , Virginia , USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Henson', 'Affiliation': 'a Department of Psychology , Old Dominion University , Norfolk , Virginia , USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2016.1185725']
809,30005555,Comparison of Mesenchymal Stem Cell Efficacy in Ischemic Versus Nonischemic Dilated Cardiomyopathy.,"BACKGROUND


Ischemic cardiomyopathy (ICM) and dilated cardiomyopathy (DCM) differ in histopathology and prognosis. Although transendocardial delivery of mesenchymal stem cells is safe and provides cardiovascular benefits in both, a comparison of mesenchymal stem cell efficacy in ICM versus DCM has not been done.
METHODS AND RESULTS


We conducted a subanalysis of 3 single-center, randomized, and blinded clinical trials: (1) TAC-HFT (Transendocardial Autologous Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells in Ischemic Heart Failure Trial); (2) POSEIDON (A Phase I/II, Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction); and (3) POSEIDON-DCM (Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy). Baseline and 1-year cardiac structure and function and quality-of-life data were compared in a post hoc pooled analysis including ICM (n=46) and DCM (n=33) patients who received autologous or allogeneic mesenchymal stem cells. Ejection fraction improved in DCM by 7% (within-group,  P =0.002) compared to ICM (1.5%; within-group,  P =0.14; between-group,  P =0.003). Similarly, stroke volume increased in DCM by 10.59 mL ( P =0.046) versus ICM (-0.2 mL;  P =0.73; between-group,  P =0.02). End-diastolic volume improved only in ICM (10.6 mL;  P =0.04) and end-systolic volume improved only in DCM (17.8 mL;  P =0.049). The sphericity index decreased only in ICM (-0.04;  P =0.0002). End-diastolic mass increased in ICM (23.1 g;  P <0.0001) versus DCM (-4.1 g;  P =0.34; between-group,  P =0.007). The 6-minute walk test improved in DCM (31.1 m;  P =0.009) and ICM (36.3 m;  P =0.006) with no between-group difference ( P =0.79). The New York Heart Association class improved in DCM ( P =0.005) and ICM ( P =0.02; between-group  P =0.20). The Minnesota Living with Heart Failure Questionnaire improved in DCM (-19.5;  P =0.002) and ICM (-6.4;  P =0.03; δ between-group difference  P =0.042) patients.
CONCLUSIONS


Mesenchymal stem cell therapy is beneficial in DCM and ICM patients, despite variable effects on cardiac phenotypic outcomes. Whereas cardiac function improved preferentially in DCM patients, ICM patients experienced reverse remodeling. Mesenchymal stem cell therapy enhanced quality of life and functional capacity in both etiologies.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifiers: TAC-HFT: NCT00768066, POSEIDON: NCT01087996, POSEIDON-DCM: NCT01392625.",2018,"The Minnesota Living with Heart Failure Questionnaire improved in DCM (-19.5;  P =0.002) and ICM (-6.4;  P =0.03; δ between-group difference  P =0.042) patients.
","['Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction', 'Ischemic Versus Nonischemic Dilated Cardiomyopathy']","['HFT', 'Mesenchymal stem cell therapy', 'TAC-HFT (Transendocardial Autologous Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells', 'DCM', 'Mesenchymal Stem Cell Efficacy', 'Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells', 'autologous or allogeneic mesenchymal stem cells', 'DCM (Percutaneous Stem Cell Injection Delivery']","['6-minute walk test improved in DCM', 'stroke volume increased in DCM', 'sphericity index', 'quality of life and functional capacity', 'Ejection fraction improved in DCM', 'systolic volume', 'cardiac function', 'ICM', 'reverse remodeling', 'End-diastolic mass increased in ICM', 'Baseline and 1-year cardiac structure and function and quality-of-life data', 'Minnesota Living with Heart Failure Questionnaire improved in DCM', 'End-diastolic volume improved only in ICM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0007193', 'cui_str': 'Cardiomyopathy, Dilated'}]","[{'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005955', 'cui_str': 'Bone Marrow Cells'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0520872', 'cui_str': 'Increased cardiac stroke volume (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0819819,"The Minnesota Living with Heart Failure Questionnaire improved in DCM (-19.5;  P =0.002) and ICM (-6.4;  P =0.03; δ between-group difference  P =0.042) patients.
","[{'ForeName': 'Bryon A', 'Initials': 'BA', 'LastName': 'Tompkins', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Rieger', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Florea', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Monisha N', 'Initials': 'MN', 'LastName': 'Banerjee', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Natsumeda', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Nigh', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ana Marie', 'Initials': 'AM', 'LastName': 'Landin', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Gianna M', 'Initials': 'GM', 'LastName': 'Rodriguez', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Konstantinos E', 'Initials': 'KE', 'LastName': 'Hatzistergos', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ivonne Hernandez', 'Initials': 'IH', 'LastName': 'Schulman', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL jhare@med.miami.edu.'}]",Journal of the American Heart Association,['10.1161/JAHA.117.008460']
810,31154414,Magnetic Resonance Imaging (MRI) Results Following Discontinuation of Methotrexate in Rheumatoid Arthritis Treated with Subcutaneous Tocilizumab: The COMP-ACT MRI Substudy.,"OBJECTIVE


To assess differences in joint damage and inflammation using magnetic resonance imaging (MRI) between patients with rheumatoid arthritis (RA) who achieved low disease activity with tocilizumab (TCZ) + methotrexate (MTX) and subsequently continued or discontinued MTX.
METHODS


In the COMP-ACT trial, US patients with RA received subcutaneous TCZ 162 mg + MTX. Those who achieved 28-joint count Disease Activity Score calculated with erythrocyte sedimentation rate (DAS28-ESR) ≤ 3.2 at Week 24 were randomized 1:1 (double-blind) to discontinue MTX (TCZ monotherapy; mono) or continue TCZ + MTX until Week 52. In a subset of patients, 1.5-Tesla MRI was used to obtain images of bilateral hands and wrists at weeks 24 and 40. Outcomes included changes in MRI-assessed synovitis, osteitis, erosion, and cartilage loss from Week 24 to Week 40, and in the proportion of patients with progression of each score.
RESULTS


Of 296 patients who achieved DAS28-ESR ≤ 3.2 at Week 24, 79 were enrolled in the pilot MRI substudy and randomized to TCZ mono (n = 38) or TCZ + MTX (n = 41). Treatment with either TCZ mono or TCZ + MTX suppressed erosion progression, synovitis, osteitis, and cartilage loss. The proportion of patients with no progression in each outcome measure was similar between groups (range, TCZ mono: 84.8-97.0%; TCZ + MTX: 92.3-100%).
CONCLUSION


In a subset of patients who achieved low disease activity with TCZ + MTX, MRI changes were minimal in intraarticular inflammation and damage measures in patients who discontinued MTX versus those who continued TCZ + MTX.",2020,Those who achieved Disease Activity Score 28 calculated with erythrocyte sedimentation rate (DAS28-ESR) ≤ 3.2 at week 24 were randomized 1:1 (double-blind) to discontinue MTX (TCZ mono) or continue TCZ + MTX until week 52.,"['296 patients who achieved DAS28-ESR ≤ 3.2 at week 24', 'Those who achieved Disease Activity Score 28 calculated with erythrocyte sedimentation rate (DAS28-ESR) ≤ 3.2 at week 24', 'patients with rheumatoid arthritis (RA) who achieved low disease activity with', 'Patients', 'With Rheumatoid Arthritis']","['Methotrexate', 'subcutaneous TCZ 162 mg + MTX', 'TCZ mono', 'TCZ mono or TCZ + MTX', 'tocilizumab (TCZ) + methotrexate (MTX', 'magnetic resonance imaging (MRI', 'Subcutaneous Tocilizumab', 'TCZ + MTX', 'discontinue MTX (TCZ mono) or continue TCZ + MTX']","['erosion progression, synovitis, osteitis, and cartilage loss', 'changes in MRI-assessed synovitis, osteitis, erosion, and cartilage loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}]","[{'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0029400', 'cui_str': 'Bone Inflammation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",296.0,0.084509,Those who achieved Disease Activity Score 28 calculated with erythrocyte sedimentation rate (DAS28-ESR) ≤ 3.2 at week 24 were randomized 1:1 (double-blind) to discontinue MTX (TCZ mono) or continue TCZ + MTX until week 52.,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peterfy', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA. Charles.peterfy@spiresciences.com.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kremer', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rigby', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Singer', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Birchwood', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Reiss', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Michalska', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Albany Medical College and The Center for Rheumatology, Albany, New York; Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire; Case Western Reserve University and MetroHealth System, Cleveland, Ohio; Genentech Inc., South San Francisco, California, USA.'}]",The Journal of rheumatology,['10.3899/jrheum.180953']
811,31116908,Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.,"BACKGROUND/OBJECTIVE


Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.
METHODS


The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke).
RESULTS


A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death.
CONCLUSIONS


Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.",2019,"Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.",['802 patients undergoing transfemoral TAVR'],"['TAVR', 'percutaneous closure device type', 'Prostar XL (PS) and ProGlide (PG', 'VCD']","['incidence of major or minor vascular complications', 'Rates of acute kidney injury', 'successful deployment rate', '30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke', 'bleeding, MACCE, and death', 'vascular and bleeding complications', 'rate of major or minor vascular complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",802.0,0.534714,"Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schäfer', 'Affiliation': 'Division of Cardiology, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Sabato', 'Initials': 'S', 'LastName': 'Sorrentino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Department of Cardiology, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kupatt', 'Affiliation': 'Department of Cardiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Department of Cardiology, Clinique Pasteur Toulouse, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Department of Cardiology, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology Bern University Hosp, Bern, Switzerland.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': 'Department of Interventional Cardiology, Sussex Cardiac Center, Brighton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Helios Heart Center Siegburg, Siegburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Herzzentrum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Department of Cardiology and INSERM UMR 1011, CHU Lille, Lille, France.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Asgar', 'Affiliation': 'Institute de Cardiologie de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Division of Cardiology, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hink', 'Affiliation': 'Department of Cardiology, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Husser', 'Affiliation': 'Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Grube', 'Affiliation': 'Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Lechthaler', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'Science and Strategy Consulting Group, Basking Ridge, New Jersey.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Science and Strategy Consulting Group, Basking Ridge, New Jersey.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai New York City, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28295']
812,31116913,Impact of intravascular ultrasound-guided drug-eluting stent implantation on patients with chronic kidney disease: Results from ULTIMATE trial.,"OBJECTIVES


This study aimed to investigate the impacts of intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation on patients with chronic kidney disease (CKD) based on the ULTIMATE trial.
BACKGROUND


IVUS-guided DES implantation improves clinical outcomes in complex lesions. However, routine IVUS guidance in patients with CKD remains controversial.
METHODS


CKD was defined as an estimated glomerular filtration rate (eGFR) <60 mL min -1  1.73 m -2  . The primary end point was target vessel failure (TVF) at 12 months, including cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization.
RESULTS


eGFR was available in 1,443 patients, of whom 723 were in the IVUS guidance group, and 720 were in the angiography guidance group. Finally, CKD was present in 349 (24.2%) patients. At 12 months, TVF in the CKD group was 7.2%, which was significantly higher than 3.2% in the non-CKD group (p = .001). Moreover, there were 25 TVFs in the CKD patients, with 7 (3.9%) TVFs in the IVUS group and 18 (10.7%) TVFs in the angiography group (hazard ratio [HR]: 0.35; 95% confidence interval [CI]: 0.15-0.84; p = .01), whereas 35 TVFs occurred in patients without CKD, with 14 (2.6%) TVFs in the IVUS group and 21 (3.8%) TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
CONCLUSIONS


This study demonstrated that CKD patients undergoing DES implantations were associated with a higher risk of TVF at 12 months. More importantly, the risk of TVF in the CKD patients could be significantly decreased through IVUS guidance.
CLINICAL TRIAL


NCT02215915.",2019,"TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
","['1,443 patients, of whom 723 were in the IVUS guidance group, and 720 were in the angiography guidance group', 'patients with chronic kidney disease', 'patients with chronic kidney disease (CKD', 'CKD patients undergoing DES implantations', 'patients with CKD']","['IVUS-guided DES implantation', 'intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation', 'intravascular ultrasound-guided drug-eluting stent implantation']","['TVFs', 'target vessel failure (TVF) at 12\u2009months, including cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization', 'risk of TVF', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517866', 'cui_str': 'Seven hundred and twenty-three'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",,0.0580723,"TVFs in the angiography group (HR: 0.67; 95% CI: 0.34-1.32; p = .25; p for interaction = .24).
","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Leng', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Cardiology, Changshu No. 1 People's Hospital, Changshu, China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Taicang, Taicang, China.""}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Zhangjiagang, Zhangjiagang, China.""}, {'ForeName': 'Qihua', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chonghao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Wuxi Third People's Hospital, Wuxi, China.""}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28308']
813,31757517,Non-fatal drug overdose after release from prison: A prospective data linkage study.,"BACKGROUND


Adults released from prison are at increased risk of poor health outcomes and preventable mortality, including from overdose. Non-fatal overdose (NFOD) is a strong predictor of future overdose and associated with considerable morbidity. This study aims to the determine the incidence, predictors and clinical characteristics of NFOD following release from prison.
METHODS


We used pre-release interview data collected for a randomised controlled trial in 2008-2010, and linked person-level, state-wide ambulance, emergency department, and hospital records, from a representative sample of 1307 adults incarcerated in Queensland, Australia. The incidence of NFOD following release from prison was calculated. A multivariate Andersen-Gill model was used to identify demographic, health, social, and criminal justice predictors of NFOD.
RESULTS


The crude incidence rate (IR) of NFOD was 47.6 (95%CI 41.1-55.0) per 1000 person-years and was highest in the first 14 days after release from prison (IR = 296 per 1000 person-years, 95%CI 206-426). In multivariate analyses, NFOD after release from prison was positively associated with a recent history of substance use disorder (SUD), dual diagnosis of mental illness and SUD, lifetime history of injecting drug use, lifetime history of NFOD, being dispensed benzodiazepines after release, a shorter index incarceration, and low perceived social support. The risk of NFOD was lower for people with high-risk alcohol use and while incarcerated.
CONCLUSIONS


Adults released from prison are at high risk of non-fatal overdose, particularly in the first 14 days after release. Providing coordinated transitional care between prison and the community is likely critical to reduce the risk of overdose.",2020,"The crude incidence rate (IR) of NFOD was 47.6 (95%CI 41.1-55.0) per 1000 person-years and was highest in the first 14 days after release from prison (IR = 296 per 1000 person-years, 95%CI 206-426).","['Non-fatal drug overdose after release from prison', '2008-2010, and linked person-level, state-wide ambulance, emergency department, and hospital records, from a representative sample of 1307 adults incarcerated in Queensland, Australia']",[],"['crude incidence rate (IR) of NFOD', 'risk of NFOD']","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0425147', 'cui_str': 'Released from prison (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019980', 'cui_str': 'Hospital Records'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1307.0,0.0682688,"The crude incidence rate (IR) of NFOD was 47.6 (95%CI 41.1-55.0) per 1000 person-years and was highest in the first 14 days after release from prison (IR = 296 per 1000 person-years, 95%CI 206-426).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Keen', 'Affiliation': 'Justice Health Unit, Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia. Electronic address: Claire.keen@unimelb.edu.au.'}, {'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Young', 'Affiliation': ""Justice Health Unit, Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia; School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia; National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.""}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Borschmann', 'Affiliation': ""Justice Health Unit, Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Kinner', 'Affiliation': ""Justice Health Unit, Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Mater Research Institute-UQ, University of Queensland, Brisbane, Queensland, Australia; Griffith Criminology Institute, Griffith University, Brisbane, Queensland, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107707']
814,31757519,Effect of nicotine lozenge use prior to smoking cue presentation on craving and withdrawal symptom severity.,"BACKGROUND


Smokers are often advised to use nicotine lozenge after cravings or withdrawal symptoms are present, which may be too late to prevent lapses. This study assesses if lozenge use prior to smoking cue exposure attenuates cue-induced increases in symptom severity.
METHODS


In this randomized, cross-over study, participants completed three laboratory sessions at which they proceeded through 4 ""rooms"" in a virtual reality environment. The first and last ""rooms"" contained neutral cues and the others contained smoking cues. At one session, a 4 mg nicotine lozenge was not given until after cue exposure (to approximate current use: i.e., after craving and withdrawal symptoms occur). At the other two sessions either a nicotine or placebo lozenge was used 15 min before cue exposure procedures. Craving and withdrawal symptoms were measured throughout each laboratory session.
RESULTS


Of 58 participants randomized; 40 completed all 3 labs. Absolute levels of craving and withdrawal symptom severity during cue exposure were lower when placebo or active lozenge was used prior to cue presentation procedures vs. no treatment until after cue presentation procedures (all p-values <0.05). There were no differences among conditions in the magnitude of symptom severity increase occurring between the first neutral room and the cue rooms.
CONCLUSIONS


Lozenge use prior to cue exposure may minimize cue induced symptom severity but when taken 15 min prior to cues the decrease is not different than placebo. Research is needed to determine if another time-frame relative to cue exposure would be more effective.",2020,"There were no differences among conditions in the magnitude of symptom severity increase occurring between the first neutral room and the cue rooms.
",['Of 58 participants randomized; 40 completed all 3 labs'],"['placebo', 'nicotine or placebo lozenge', 'nicotine lozenge']","['Craving and withdrawal symptoms', 'Absolute levels of craving and withdrawal symptom severity', 'craving and withdrawal symptom severity']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C1253423', 'cui_str': 'Nicotine Oral Lozenge'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",58.0,0.0186569,"There were no differences among conditions in the magnitude of symptom severity increase occurring between the first neutral room and the cue rooms.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kotlyar', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street SE, Minneapolis, MN 55455, United States; Department of Psychiatry, University of Minnesota, United States. Electronic address: kotly001@umn.edu.'}, {'ForeName': 'Rachel I', 'Initials': 'RI', 'LastName': 'Vogel', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health, University of Minnesota, United States.""}, {'ForeName': 'Sheena R', 'Initials': 'SR', 'LastName': 'Dufresne', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street SE, Minneapolis, MN 55455, United States.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mills', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street SE, Minneapolis, MN 55455, United States.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Vuchetich', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107706']
815,31078482,Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF.,"OBJECTIVES


The purpose of this study was to compare outcomes (and the effect of sacubitril/valsartan) according to etiology in the PARADIGM-HF (Prospective comparison of angiotensin-receptor-neprilysin inhibitor [ARNI] with angiotensin-converting-enzyme inhibitor [ACEI] to Determine Impact on Global Mortality and morbidity in Heart Failure) trial.
BACKGROUND


Etiology of heart failure (HF) has changed over time in more developed countries and is also evolving in non-Western societies. Outcomes may vary according to etiology, as may the effects of therapy.
METHODS


We examined outcomes and the effect of sacubtril/valsartan according to investigator-reported etiology in PARADIGM-HF. The outcomes analyzed were the primary composite of cardiovascular death or HF hospitalization, and components, and death from any cause. Outcomes were adjusted for known prognostic variables including N terminal pro-B type natriuretic peptide.
RESULTS


Among the 8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology. Among the 3,363 patients (40.0%) with a nonischemic etiology, 1,595 (19.0% of all patients; 47% of nonischemic patients) had idiopathic dilated cardiomyopathy, 968 (11.5% of all patients; 28.8% of nonischemic patients) had a hypertensive cause, and 800 (9.5% of all patients, 23.8% of nonischemic patients) another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other). Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87 (95% confidence interval [CI]: 0.75 to 1.02), idiopathic 0.92 (95% CI: 0.82 to 1.04) and other 1.00 (95% CI: 0.85 to 1.17). The benefit of sacubitril/valsartan over enalapril was consistent across etiologic categories (interaction for primary outcome; p = 0.11).
CONCLUSIONS


Just under one-half of patients in this global trial had nonischemic HF with reduced ejection fraction, with idiopathic and hypertensive the most commonly ascribed etiologies. Adjusted outcomes were similar across etiologic categories, as was the benefit of sacubitril/valsartan over enalapril. (Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure; NCT01035255).",2019,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","['Patients With Chronic Heart\xa0Failure', 'another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other', '8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology']","['enalapril', 'angiotensin-receptor-neprilysin inhibitor [ARNI', 'Enalapril', 'angiotensin-converting-enzyme inhibitor [ACEI', 'sacubitril/valsartan', 'LCZ696', 'sacubtril/valsartan']","['idiopathic dilated cardiomyopathy', 'hypertensive cause', 'cardiovascular death or HF hospitalization, and components, and death from any cause', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C1449563', 'cui_str': 'Cardiomyopathy, Dilated, LMNA'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",8399.0,0.177835,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Balmforth', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute and University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.02.015']
816,31081694,A phase III trial of  tirasemtiv  as a potential treatment for amyotrophic lateral sclerosis.,"Objective


To assess the efficacy of tirasemtiv, a fast skeletal muscle troponin activator, vs. placebo in patients with amyotrophic lateral sclerosis. Methods: VITALITY-ALS (NCT02496767) was a multinational, double-blind, randomized, placebo-controlled clinical trial. Participants tolerating 2 weeks of open-label tirasemtiv (125 mg twice daily) were randomized 3:2:2:2 to placebo or one of three target tirasemtiv dose levels, using an escalating dosage protocol lasting 28 days. The primary outcome measure was changed in slow vital capacity (SVC) at 24 weeks. Secondary endpoints included a change in muscle strength and time to respiratory milestones of disease progression.
Results


Of 744 participants, 565 tolerated open-label tirasemtiv and received randomized treatment. By 24 weeks, 23 (12.2%) placebo-treated participants discontinued study treatment vs. 129 (34.2%) randomized to tirasemtiv. SVC declined by 14.4% (95% CI: −16.8, −11.9) in the placebo group and 13.4% (95% CI: −15.3, −11.6) in the tirasemtiv group (p = 0.56). Secondary endpoints did not show significant differences. However, participants who tolerated tirasemtiv at their randomized dose showed a numeric trend toward a dose-related slowing of decline in SVC (p = 0.11). Dizziness, fatigue, nausea, weight loss, and insomnia occurred more frequently on tirasemtiv. Serious adverse events were similar across groups.
Conclusions


Tirasemtiv did not alter the decline of SVC or significantly impact secondary outcome measures. Poor tolerability of tirasemtiv may have contributed to this result. However, participants tolerating their intended dose exhibited a trend toward treatment benefit on SVC, suggesting the underlying mechanism of action may still hold promise, as is being tested with a different fast skeletal muscle troponin activator (NCT03160898).",2019,"SVC declined by 14.4% (95% CI: -16.8, -11.9) in the placebo group and 13.4% (95% CI: -15.3, -11.6) in the  tirasemtiv  group ( p  = 0.56).","['patients with amyotrophic lateral sclerosis', '744 participants, 565 tolerated open-label  tirasemtiv  and received randomized treatment', 'amyotrophic lateral sclerosis']","['tirasemtiv , a fast skeletal muscle troponin activator, vs. placebo', 'placebo']","['SVC', 'slow vital capacity (SVC', 'Dizziness, fatigue, nausea, weight loss, and insomnia', 'change in muscle strength and time to respiratory milestones of disease progression', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3713987'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3713987'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231957', 'cui_str': 'Slow vital capacity (observable entity)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",744.0,0.542692,"SVC declined by 14.4% (95% CI: -16.8, -11.9) in the placebo group and 13.4% (95% CI: -15.3, -11.6) in the  tirasemtiv  group ( p  = 0.56).","[{'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'Department of Neurology, Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hardiman', 'Affiliation': 'Academic Unit of Neurology, Trinity Biomedical Sciences Institute, Trinity College, Dublin, Ireland.'}, {'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Cockcroft', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Rudnicki', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wolff', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jinsy A', 'Initials': 'JA', 'LastName': 'Andrews', 'Affiliation': 'The Neurological Institute, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2019.1612922']
817,31757838,Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial.,"OBJECTIVE


To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS


Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria).
RESULTS


EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m 2  [95% CI -0.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA 1c -lowering or prior retinopathy subgroups. CV outcomes in those with eGFR <60 mL/min/1.73 m 2  did not differ by group. Those with eGFR ≥60 mL/min/1.73 m 2  had nominal risk reductions for MACE, all-cause mortality, and CV death, but interactions by renal function group were significant for only stroke (HR 0.74 [95% CI 0.58-0.93];  P  for interaction = 0.035) and CV death (HR 1.08 [95% CI 0.85-1.38];  P  for interaction = 0.031).
CONCLUSIONS


EQW had no impact on unadjusted retinopathy or renal outcomes. CV risk was modestly reduced only in those with eGFR ≥60 mL/min/1.73 m 2  in analyses unadjusted for multiplicity.",2020,CV risk was modestly reduced only in those with eGFR ≥60,"['groups was calculated for 13,844 participants']","['placebo', 'EQW', 'exenatide (EQW']","['renal composite 2', 'CV risk', 'unadjusted retinopathy or renal outcomes', 'Microvascular and Cardiovascular Outcomes', 'renal replacement, or renal death', 'renal composite', 'Retinopathy rates', 'CV outcomes', 'CV death', 'Macroalbuminuria', 'nominal risk reductions for MACE, all-cause mortality, and CV death', 'glomerular filtration rate (eGFR', 'microvascular and cardiovascular (CV) outcomes', 'incident macroalbuminuria, retinopathy, and major adverse CV events (MACE']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.309193,CV risk was modestly reduced only in those with eGFR ≥60,"[{'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Neli', 'Initials': 'N', 'LastName': 'Jakuboniene', 'Affiliation': 'Department of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ohman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K. rury.holman@dtu.ox.ac.uk.'}]",Diabetes care,['10.2337/dc19-1065']
818,31912649,Pre-pregnancy iodized salt improved children's cognitive development in randomized trial in Ethiopia.,"The overarching Ethiopia project examined the effects of early market introduction of iodized salt on the growth and mental development of young children. Sixty districts were randomly assigned to intervention (early market access to iodized salt) or control (later access through market forces), and one community per district was randomly chosen as the sampling unit. For this project, 22 of the districts were included. The participants were 1,220 pregnant women who conceived after the intervention began. When their children were 2 to 13 months old, field staff collected information on household sociodemographic status and iodized salt intake, child stimulation, maternal depression symptoms, children's diet, anthropometry, urinary iodine concentration (UIC), hemoglobin, and mental development scores (Bayley III scales). Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05) were iodine deficient (UIC <50 μg/L) in the intervention compared with the control group. The intervention children had higher cognitive scores (33.3 ± 0.3 vs. 32.6 ± 0.3; Δ = 0.6; 95% CI [0.0, 1.3]; d = 0.17; p = .01; 4 IQ points) than their controls. The other Bayley subscale scores did not differ from control children. The intervention group had a higher child stimulation (22.7 ± 0.2 vs. 22.1 ± 0.2; Δ = 0.5; 95% CI [0.02, 0.89]; d = 0.17; p = .01) but not growth indicators (weight-for-age z score, length-for-age z score, and weight-for-length z score: -1.1 ± 0.1 vs. -1.1 ± 0.1, -1.7 ± 0.1 vs. -1.7 ± 0.1; -0.2 ± 0.1 vs. -0.1 ± 0.1, respectively, all p > .05) compared with their controls. Iodized salt intake improved iodine status of both pregnant women and their children and also child cognitive development.",2020,"Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05)","['Sixty districts', '1,220 pregnant women who conceived after the intervention began', 'young children', ""children's cognitive development in randomized trial in Ethiopia""]","['Pre-pregnancy iodized salt', 'intervention (early market access to iodized salt) or control (later access through market forces', 'Iodized salt intake', 'iodized salt']","['higher cognitive scores', 'iodine status', ""household sociodemographic status and iodized salt intake, child stimulation, maternal depression symptoms, children's diet, anthropometry, urinary iodine concentration (UIC), hemoglobin, and mental development scores (Bayley III scales"", 'Bayley subscale scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0063758', 'cui_str': 'iodinated salt'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0063758', 'cui_str': 'iodinated salt'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0222045'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",1220.0,0.0256268,"Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05)","[{'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Mohammed', 'Affiliation': 'Nutrition and Food Science Department, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Marquis', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Quebec, Canada.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Aboud', 'Affiliation': 'Department of Psychology, McGill University, Quebec, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bougma', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Quebec, Canada.'}, {'ForeName': 'Aregash', 'Initials': 'A', 'LastName': 'Samuel', 'Affiliation': 'Food Sciences and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.'}]",Maternal & child nutrition,['10.1111/mcn.12943']
819,30659416,Exploring the feasibility of a mild and short 4-week combined upper limb and breathing exercise program as a possible home base program to decrease fatigue and improve quality of life in ambulatory and non-ambulatory multiple sclerosis individuals.,"PURPOSE


To evaluate the feasibility of a combined upper limb and breathing exercise for a home-based program and to explore its effect on primary fatigue and quality of life in ambulatory and non-ambulatory individuals with multiple sclerosis (MS) in a short time.
METHOD


Nineteen individuals with MS were assigned into semi-controlled pre-post feasibility study based on Expanded Disability Status Scale (EDSS) status and divided into two groups: exercise (five ambulatory, five non-ambulatory; EDSS 1.0-8.0) and related control with no exercise (four ambulatory, five non-ambulatory; EDSS 1.0-7.5). Exercise group performed combined upper limb and breathing exercise in a controlled group (2 days/week, 60 min/session) accompanied by independent home exercise (3 days/week, ≥ 20 min/session). Participants underwent measures of fatigue impact (Modified Fatigue Impact Scale (MFIS) and quality of life (RAND Medical outcomes study 36-item short-form health survey (SF-36)) before and after a 4-week period.
RESULTS


The MFIS (physical, psychosocial, total) showed statistically significant group-by-time interaction in ambulatory (p = 0.033, d = 1.60; p = 0.039, d = 1.59; p = 0.033, d = 1.62) and non-ambulatory individuals (p = 0.009, d = 2.42; p = 0.018, d = 1.96; p = 0.0008, d = 3.92). Physical functioning (SF-36) showed statistically significant group-by-time interaction in ambulatory (p = 0.014, d = 2.14) but no significance in non-ambulatory (p = 0.368, d = 0.68) individuals. Despite the absent statistical significance, there were large intervention effects on MFIS cognitive scores for ambulatory (d = 1.28) and non-ambulatory (d = 1.47), and on other SF-36 scores for ambulatory (general health: d = 1.76 and pain: d = 1.02) and non-ambulatory (physical limitation: d = 1.03 and emotional well-being: d = 0.94) individuals.
CONCLUSION


Our 4-week program reduced some aspects of fatigue and improved some aspects of quality of life in a small group of ambulatory and non-ambulatory individuals with MS. Good feasibility and significant positive changes from baseline warrant further exploratory work.
TRIAL REGISTRATION


Name of the registry: The Impact of Exercise Training on Living Quality in Multiple Sclerosis. Registration: The study was registered at www.clinicaltrial.gov on July 14, 2017. First participant enrollment: August 28, 2017. URL: 602-01/17-01-147; Trial registration ID: NTC03222596.",2019,"Physical functioning (SF-36) showed statistically significant group-by-time interaction in ambulatory (p = 0.014, d = 2.14) but no significance in non-ambulatory (p = 0.368, d = 0.68) individuals.","['Nineteen individuals with MS', 'Registration', 'Multiple Sclerosis', 'ambulatory and non-ambulatory multiple sclerosis individuals', 'ambulatory and non-ambulatory individuals with multiple sclerosis (MS']","['Exercise Training', 'combined upper limb and breathing exercise', 'semi-controlled pre-post feasibility study based on Expanded Disability Status Scale (EDSS) status and divided into two groups: exercise (five ambulatory, five non-ambulatory; EDSS 1.0-8.0) and related control with no exercise (four ambulatory, five non-ambulatory; EDSS 1.0-7.5', 'mild and short 4-week combined upper limb and breathing exercise program', 'Exercise group performed combined upper limb and breathing exercise']","['fatigue and improve quality of life', 'MFIS cognitive scores', 'quality of life', 'Physical functioning (SF-36', 'MFIS (physical, psychosocial, total', 'primary fatigue and quality of life', 'fatigue impact (Modified Fatigue Impact Scale (MFIS) and quality of life (RAND Medical outcomes study 36-item short-form health survey (SF-36']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale (assessment scale)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",19.0,0.0113876,"Physical functioning (SF-36) showed statistically significant group-by-time interaction in ambulatory (p = 0.014, d = 2.14) but no significance in non-ambulatory (p = 0.368, d = 0.68) individuals.","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Grubić Kezele', 'Affiliation': 'Department of Physiology and Immunology, University of Rijeka Faculty of Medicine, B. Branchetta 20, 51000, Rijeka, Croatia. tanja.grubic@medri.uniri.hr.'}, {'ForeName': 'Matea', 'Initials': 'M', 'LastName': 'Babić', 'Affiliation': 'Department of Physiotherapy, University of Rijeka Faculty of Health Studies, Rijeka, Croatia.'}, {'ForeName': 'Dinko', 'Initials': 'D', 'LastName': 'Štimac', 'Affiliation': 'Department of Neurosurgery, Clinical Hospital Center, Rijeka, Croatia.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-3707-0']
820,31752042,Efficacy and Safety of Glycoprotein IIb/IIIa Inhibitors on Top of Ticagrelor in STEMI: A Subanalysis of the ATLANTIC Trial.,"BACKGROUND


Glycoprotein IIb/IIIa inhibitors (GPIs) in combination with clopidogrel improve clinical outcome in ST-elevation myocardial infarction (STEMI); however, finding a balance that minimizes both thrombotic and bleeding risk remains fundamental. The efficacy and safety of GPI in addition to ticagrelor, a more potent P2Y12-inhibitor, have not been fully investigated.
METHODS


1,630 STEMI patients who underwent primary percutaneous coronary intervention (PCI) were analyzed in this subanalysis of the ATLANTIC trial. Patients were divided in three groups: no GPI, GPI administration routinely before primary PCI, and GPI administration in bailout situations. The primary efficacy outcome was a composite of death, myocardial infarction, urgent target revascularization, and definite stent thrombosis at 30 days. The safety outcome was non-coronary artery bypass graft (CABG)-related PLATO major bleeding at 30 days.
RESULTS


Compared with no GPI ( n  = 930), routine GPI ( n  = 525) or bailout GPI ( n  = 175) was not associated with an improved primary efficacy outcome (4.2% no GPI vs. 4.0% routine GPI vs. 6.9% bailout GPI;  p  = 0.58). After multivariate analysis, the use of GPI in bailout situations was associated with a higher incidence of non-CABG-related bleeding compared with no GPI (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.32-6.64;  p  = 0.03). However, routine GPI use compared with no GPI was not associated with a significant increase in bleeding (OR 1.78, 95% CI 0.88-3.61;  p  = 0.92).
CONCLUSION


Use of GPIs in addition to ticagrelor in STEMI patients was not associated with an improvement in 30-day ischemic outcome. A significant increase in 30-day non-CABG-related PLATO major bleeding was seen in patients who received GPIs in a bailout situation.",2020,"After multivariate analysis, the use of GPI in bailout situations was associated with a higher incidence of non-CABG-related bleeding compared with no GPI (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.32-6.64;  p  = 0.03).","['1,630 STEMI patients who underwent primary percutaneous coronary intervention (PCI', 'STEMI']","['clopidogrel', 'no GPI', 'Glycoprotein IIb/IIIa Inhibitors', 'ticagrelor', 'Glycoprotein IIb/IIIa inhibitors (GPIs']","['primary efficacy outcome', '30-day ischemic outcome', 'composite of death, myocardial infarction, urgent target revascularization, and definite stent thrombosis at 30 days', 'bleeding', '30-day non-CABG-related PLATO major bleeding']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0043566', 'cui_str': 'PLATO'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",1630.0,0.0896868,"After multivariate analysis, the use of GPI in bailout situations was associated with a higher incidence of non-CABG-related bleeding compared with no GPI (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.32-6.64;  p  = 0.03).","[{'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Tavenier', 'Affiliation': 'Department of Cardiology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Cardiovascular Department, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'SAMU 93, Hôspital Avícenne, Bobigny, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'ACTION Study Group, Pitié-Salpêtrière Hospital (AP-HP), Sorbonne University, Paris, France.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, Azienda Ospedaliera, Toscana Sudest, Arezzo, Italy.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Division of Cardiology, Southlake Regional Health Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Cequier', 'Affiliation': 'Heart Disease Institute, Bellvitge University Hospital, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Chettibi', 'Affiliation': 'Centre Hospitalo Universitaire Frantz Fanon, Blida, Algeria.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammett', 'Affiliation': ""Department of Cardiology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenspital , Medical School, Sigmund Freud University, Vienna, Austria.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Janzon', 'Affiliation': 'Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen und Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ecollan', 'Affiliation': 'ACTION Study Group, Pitié-Salpêtrière Hospital (AP-HP), Sorbonne University, Paris, France.'}, {'ForeName': 'Jean-Phillipe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'ACTION Study Group, Pitié-Salpêtrière Hospital (AP-HP), Sorbonne University, Paris, France.'}, {'ForeName': 'Frank F', 'Initials': 'FF', 'LastName': 'Willems', 'Affiliation': 'Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Abdourahmane', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'ACTION Study Group, Statistical Unit, Lariboisière Hospital (AP-HP), Paris VII University, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'ACTION Study Group, Statistical Unit, Lariboisière Hospital (AP-HP), Paris VII University, Paris, France.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Campus, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, Pitié-Salpêtrière Hospital (AP-HP), Sorbonne University, Paris, France.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Cardiology, Isala, Zwolle, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thrombosis and haemostasis,['10.1055/s-0039-1700546']
821,30174281,"Assessing statin effects on cardiovascular pathways in HIV using a novel proteomics approach: Analysis of data from INTREPID, a randomized controlled trial.","BACKGROUND


People with HIV (PWH) demonstrate increased cardiovascular disease (CVD), due in part to increased immune activation, inflammation, and endothelial dysfunction.
METHODS


In a randomized trial (INTREPID), 252 HIV-infected participants with dyslipidemia and no history of coronary artery disease were randomized (1:1) to pitavastatin 4 mg vs. pravastatin 40 mg for 52 weeks. Using a proteomic discovery approach, 92 proteins biomarkers were assessed using Proximity Extension Assay technology to determine the effects of statins on key atherosclerosis and CVD pathways among PWH. 225 participants had specimens available for biomarker analysis pre- and post-baseline.
FINDINGS


The mean age was 49.5 ± 8.0 (mean ± SD), LDL-C 155 ± 25 mg/dl and CD4 count 620 ± 243 cell/mm 3 . Among all participants, three proteins significantly decreased: tissue factor pathway inhibitor [TFPI; t-statistic = -6.38, FDR p-value<0.0001], paraoxonase 3 [PON3; t-statistic = -4.64, FDR p-value = 0.0003], and LDL-receptor [LDLR; t-statistic = -4.45, FDR p-value = 0.0004]; and two proteins significantly increased galectin-4 [Gal-4; t-statistic = 3.50, FDR p-value = 0.01] and insulin-like growth factor binding protein 2 [IGFBP-2; t-statistic = 3.21, FDR p-value = 0.03]. The change in TFPI was significantly different between the pitavastatin and pravastatin groups. Among all participants, change in TFPI related to the change in LDL-C (r = 0.43, P < 0.0001) and change in Lp-PLA2 (r = 0.29, P < 0.0001).
INTERPRETATION


Using a proteomics approach, we demonstrated that statins led to a significant reduction in the levels of TFPI, PON3, and LDLR and an increase in Gal-4 and IGFBP-2, key proteins involved in coagulation, redox signaling, oxidative stress, and glucose metabolism. Pitavastatin led to a greater reduction in TFPI than pravastatin. These data highlight potential novel mechanisms of statin effects among PWH. FUND: This work was supported by an investigator-initiated grant to S.K.G. from KOWA Pharmaceuticals America, Inc. and the National Institutes of Health [P30 DK040561; Nutrition Obesity Research Center at Harvard]. M.T. was support by National Institutes of Health [5KL2TR001100-05; Harvard Catalyst KL2 grant].",2018,"Among all participants, change in TFPI related to the change in LDL-C (r = 0.43, P < 0.0001) and change in Lp-PLA2 (r = 0.29, P < 0.0001).
","['252 HIV-infected participants with dyslipidemia and no history of coronary artery disease', 'The mean age was 49.5\u202f±\u202f8.0 (mean\u202f±\u202fSD), LDL-C 155\u202f±\u202f25\u202fmg/dl and CD4 count 620\u202f±\u202f243 cell/mm 3 ', 'FUND', 'People with HIV (PWH', '225 participants had specimens available for biomarker analysis pre- and post-baseline']","['pitavastatin and pravastatin', 'pitavastatin 4\u202fmg vs. pravastatin', 'pravastatin', 'Pitavastatin', 'tissue factor pathway inhibitor']","['TFPI', 'levels of TFPI, PON3, and LDLR and an increase in Gal-4 and IGFBP-2, key proteins involved in coagulation, redox signaling, oxidative stress, and glucose metabolism', 'change in Lp-PLA2', 'cardiovascular disease (CVD', 'change in TFPI']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0164707', 'cui_str': 'TFPI'}]","[{'cui': 'C0164707', 'cui_str': 'TFPI'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1705853', 'cui_str': 'Imperial gallon'}, {'cui': 'C0123257', 'cui_str': 'Insulin-Like Growth Factor Binding Protein 2'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0914069', 'cui_str': '1-Alkyl-2-acetylglycerophosphocholine Esterase'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",,0.119683,"Among all participants, change in TFPI related to the change in LDL-C (r = 0.43, P < 0.0001) and change in Lp-PLA2 (r = 0.29, P < 0.0001).
","[{'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'de Filippi', 'Affiliation': 'Inova Heart and Vascular Institute (CD), Falls Church, VA, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'KOWA Pharmaceuticals America Inc. (CAS), Montgomery, AL, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital, Biostatistics Center, and Harvard Medical School (HL), Boston, MA, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Grundberg', 'Affiliation': 'Olink Proteomics (IG), Watertown, MA, USA.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta (MAT), Atlanta, GA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Mount Sinai Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai (JAA), New York, NY, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Massachusetts General Hospital, Program in Nutritional Metabolism and Harvard Medical School (MT, KVF, LS, MVZ, JL, SKG), Boston, MA, USA. Electronic address: sgrinspoon@partners.org.'}]",EBioMedicine,['10.1016/j.ebiom.2018.08.039']
822,31751758,Optimizing Value in the Evaluation of Chronic Spontaneous Urticaria: A Cost-Effectiveness Analysis.,"BACKGROUND


Chronic spontaneous urticaria (CSU) affects approximately 1% of the general population. The cost-effectiveness of routine laboratory testing for secondary causes of CSU has not been formally evaluated.
OBJECTIVE


To characterize the cost-effectiveness of routine laboratory screening in adults with CSU.
METHODS


A Markov model using cohort analysis and microsimulations was created for adult patients aged 20 years, over a 10-year time horizon, randomized to receive screening laboratory testing or a no-testing approach. Laboratory results were derived from a previously published retrospective analysis of adult patients with CSU. Cost-effectiveness was evaluated at a willingness to pay threshold of $100,000/quality-adjusted life-year using the incremental cost-effectiveness ratio (ICER) in patients with untreated CSU, and patients treated with antihistamines, cyclosporine, or omalizumab.
RESULTS


Average laboratory costs per simulated patient with CSU were $573 (standard deviation [SD], $41), with only 0.16% (SD, 3.99%) of tests resulting in improved clinical outcomes. Testing costs per laboratory-associated positive outcome were $358,052 (no therapy), $357,576 (antihistamine therapy), $354,115 (cyclosporine), and $262,121 (omalizumab). Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (antihistamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab). In the omalizumab-treated subgroup, testing could be cost-effective below $220 or if it resulted in a 0.73% rate of CSU resolution. From a simulated US population perspective, nation-wide screening costs could reach $941,750,741 to $1,833,501,483.
CONCLUSIONS


In CSU, the likelihood of clinical improvement from laboratory testing is very low, and testing is not cost-effective. These data support recommendations to not routinely perform laboratory testing in patients with CSU with otherwise normal histories and physical evaluations.",2020,"Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (anti-histamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab).","['adult patients aged 20 years', 'Chronic Spontaneous Urticaria', 'adults with CSU', 'CSU patients with otherwise normal histories and physical evaluations']","['routine laboratory screening', 'screening laboratory testing or a no-testing approach', 'cyclosporine, or omalizumab']","['incremental cost-effectiveness ratio (ICER', 'Cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0998448,"Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (anti-histamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab).","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Shaker', 'Affiliation': 'Section of Allergy and Immunology, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Department of Pediatrics, Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Community and Family Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH. Electronic address: Marcus.S.Shaker@hitchcock.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oppenheimer', 'Affiliation': 'Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Department of Medicine, Nova Southeastern Allopathic Medical School, Fort Lauderdale, Fla.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lang', 'Affiliation': 'Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rambasek', 'Affiliation': 'Division of Allergy and Immunology, Ohio University Heritage College of Osteopathic Medicine, Sandusky, Ohio.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dykewicz', 'Affiliation': 'Department of Internal Medicine, Section of Allergy and Immunology, Saint Louis University School of Medicine, St. Louis, Mo.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Section of Allergy and Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.11.004']
823,29145950,A Combination of Allogeneic Stem Cells Promotes Cardiac Regeneration.,"BACKGROUND


The combination of autologous mesenchymal stem cells (MSCs) and cardiac stem cells (CSCs) synergistically reduces scar size and improves cardiac function in ischemic cardiomyopathy. Whereas allogeneic (allo-)MSCs are immunoevasive, the capacity of CSCs to similarly elude the immune system remains controversial, potentially limiting the success of allogeneic cell combination therapy (ACCT).
OBJECTIVES


This study sought to test the hypothesis that ACCT synergistically promotes cardiac regeneration without provoking immunologic reactions.
METHODS


Göttingen swine with experimental ischemic cardiomyopathy were randomized to receive transendocardial injections of allo-MSCs + allo-CSCs (ACCT: 200 million MSCs/1 million CSCs, n = 7), 200 million allo-MSCs (n = 8), 1 million allo-CSCs (n = 4), or placebo (Plasma-Lyte A, n = 6). Swine were assessed by cardiac magnetic resonance imaging and pressure volume catheterization. Immune response was tested by histologic analyses.
RESULTS


Both ACCT and allo-MSCs reduced scar size by -11.1 ± 4.8% (p = 0.012) and -9.5 ± 4.8% (p = 0.047), respectively. Only ACCT, but not MSCs or CSCs, prevented ongoing negative remodeling by offsetting increases in chamber volumes. Importantly, ACCT exerted the greatest effect on systolic function, improving the end-systolic pressure-volume relation (+0.98 ± 0.41 mm Hg/ml; p = 0.016). The ACCT group had more phospho-histone H3+ (a marker of mitosis) cardiomyocytes (p = 0.04), and noncardiomyocytes (p = 0.0002) than did the placebo group in some regions of the heart. Inflammatory sites in ACCT and MSC-treated swine contained immunotolerant CD3 + /CD25 + /FoxP3 +  regulatory T cells (p < 0.0001). Histologic analysis showed absent to low-grade inflammatory infiltrates without cardiomyocyte necrosis.
CONCLUSIONS


ACCT demonstrates synergistic effects to enhance cardiac regeneration and left ventricular functional recovery in a swine model of chronic ischemic cardiomyopathy without adverse immunologic reaction. Clinical translation to humans is warranted.",2017,Inflammatory sites in ACCT and MSC-treated swine contained immunotolerant CD3 + /CD25 + /FoxP3 +  regulatory T cells (p < 0.0001).,['Göttingen swine with experimental ischemic cardiomyopathy'],"['autologous mesenchymal stem cells (MSCs) and cardiac stem cells (CSCs', 'placebo', 'ACCT', 'transendocardial injections of allo-MSCs\xa0+ allo-CSCs (ACCT: 200 million MSCs/1 million CSCs, n\xa0=\xa07), 200 million allo-MSCs (n\xa0=\xa08), 1\xa0million allo-CSCs (n\xa0=\xa04), or placebo (Plasma-Lyte A, n\xa0=\xa06', 'Allogeneic Stem Cells']","['Immune response', 'scar size', 'phospho-histone H3', 'cardiac magnetic resonance imaging and pressure volume catheterization', 'systolic function, improving the end-systolic pressure-volume relation']","[{'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0019647', 'cui_str': 'Histone H3'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.145162,Inflammatory sites in ACCT and MSC-treated swine contained immunotolerant CD3 + /CD25 + /FoxP3 +  regulatory T cells (p < 0.0001).,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Natsumeda', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Florea', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Rieger', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Bryon A', 'Initials': 'BA', 'LastName': 'Tompkins', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Monisha N', 'Initials': 'MN', 'LastName': 'Banerjee', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Golpanian', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritsch', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ana Marie', 'Initials': 'AM', 'LastName': 'Landin', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Nilesh D', 'Initials': 'ND', 'LastName': 'Kashikar', 'Affiliation': 'Department of Pathology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Karantalis', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Viky Y', 'Initials': 'VY', 'LastName': 'Loescher', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kostas E', 'Initials': 'KE', 'LastName': 'Hatzistergos', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Luiza', 'Initials': 'L', 'LastName': 'Bagno', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sanina', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Muzammil', 'Initials': 'M', 'LastName': 'Mushtaq', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodriguez', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rosado', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Collon', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Vincent', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Kanelidis', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ivonne H', 'Initials': 'IH', 'LastName': 'Schulman', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Mitrani', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Heldman', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Balkan', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: jhare@med.miami.edu.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2017.09.036']
824,31758471,Relevant Weight Reduction and Reversed Metabolic Co-morbidities Can Be Achieved by Duodenojejunal Bypass Liner in Adolescents with Morbid Obesity.,"BACKGROUND


Duodenojejunal bypass liner (DJBL) is an endoscopic, reversible bariatric procedure resulting in weight loss and metabolic co-morbidities improvements in the adults.
OBJECTIVES


To determine safety and effectiveness of 12-month treatment with DJBL in adolescents with severe obesity (BMI > 35 kg/m 2 ) and co-morbidities.
METHODS


Post-pubertal subjects were treated with DJBL in an open-label, prospective clinical trial (NTC0218393). They were examined at 3 monthly intervals during the 12 months of DJBL treatment and 12 months of follow-up.
RESULTS


DJBL was successfully placed in 19/22 adolescents (13 females, mean age (95%CI); 17.3 (16.7-17.9) years, BMI-SDS 3.7 (3.6-3.9)). There were no serious device-related adverse effects. Clinically relevant percent total weight loss (%TWL) (mean (95%CI)) 11.4 (7.4-15.3) % and BMI decrease - 4.9 (- 2.4 to - 7.4) kg/m 2  was observed at DJBL removal (n = 19). At 12 months after device removal, %TWL was 4.1 (- 2.6-10.8) % and BMI decrease - 2.6 (0.2 to - 5.4) kg/m 2  when compared with values at baseline (n = 13). HOMA-IR (- 2.1 (- 3 to - 1.3), WBISI 1.15 (0.23 to 2.07), total cholesterol, LDL-c, and triglycerides levels also improved during DJBL treatment and relapsed similarly to weight at 12-month follow-up. A decrease in iron stores, Zn, and Se levels was determined during DJBL treatment and spontaneously improved at follow-up.
CONCLUSIONS


Twelve months of DJBL treatment was safe and effective in adolescents with morbid obesity. Weight regain following device removal and relapse of metabolic complications should be expected.",2020,There were no serious device-related adverse effects.,"['adolescents with morbid obesity', '19/22 adolescents (13 females, mean age (95%CI', 'adolescents with severe obesity (BMI > 35 kg/m 2 ) and co-morbidities.\nMETHODS\n\n\nPost-pubertal subjects', 'Adolescents with Morbid Obesity']","['Duodenojejunal bypass liner (DJBL', 'Duodenojejunal Bypass Liner', 'DJBL']","['Relevant Weight Reduction and Reversed Metabolic', 'Weight regain', 'iron stores, Zn, and Se levels', 'total cholesterol, LDL-c, and triglycerides levels', 'Co-morbidities', 'mean (95%CI', 'serious device-related adverse effects', 'total weight loss (%TWL', 'HOMA-IR']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1626404', 'cui_str': 'Post-pubertal'}]","[{'cui': 'C0450198', 'cui_str': 'Duodenojejunal (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0273943,There were no serious device-related adverse effects.,"[{'ForeName': 'Matjaž', 'Initials': 'M', 'LastName': 'Homan', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia. matjaz.homan@guest.arnes.si.""}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Kovač', 'Affiliation': ""Unit of Special Laboratory Diagnostics, University Children's Hospital, University Medical Center Ljubljana, Vrazov trg 1, SI-1000, Ljubljana, Slovenia.""}, {'ForeName': 'Rok', 'Initials': 'R', 'LastName': 'Orel', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.'}, {'ForeName': 'Primož', 'Initials': 'P', 'LastName': 'Kotnik', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.'}]",Obesity surgery,['10.1007/s11695-019-04279-4']
825,30465137,Control of metabolic predisposition to cardiovascular complications of chronic kidney disease by effervescent calcium magnesium citrate: a feasibility study.,"AIMS


Cardiovascular (CV) complications are common in chronic kidney disease (CKD). Numerous metabolic disturbances including hyperphosphatemia, high circulating calciprotein particles (CPP), hyperparathyroidism, metabolic acidosis, and magnesium deficiency are associated with, and likely pathogenic for CV complications in CKD. The goal of this feasibility study was to determine whether effervescent calcium magnesium citrate (EffCaMgCit) ameliorates the aforementioned pathogenic intermediates.
METHODS


Nine patients with Stage 3 and nine patients with Stage 5D CKD underwent a randomized crossover study, where they took EffCaMgCit three times daily for 7 days in one phase, and a conventional phosphorus binder calcium acetate (CaAc) three times daily for 7 days in the other phase. Two-hour postprandial blood samples were obtained on the day before and on the 7th day of treatment.
RESULTS


In Stage 5D CKD, EffCaMgCit significantly increased T50 (half time for conversion of primary to secondary CPP) from baseline by 63% (P = 0.013), coincident with statistically non-significant declines in serum phosphorus by 25% and in saturation of octacalcium phosphate by 35%; CaAc did not change T50. In Stage 3 CKD, neither EffCaMgCit nor CaAc altered T50. With EffCaMgCit, a significant increase in plasma citrate was accompanied by statistically non-significant increase in serum Mg and phosphate. CaAc was without effect in any of these parameters in Stage 3 CKD. In both Stages 3 and 5D, both drugs significantly reduced serum parathyroid hormone. Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


In Stage 5D, EffCaMgCit inhibited formation of CPP, suppressed PTH, and conferred magnesium and alkali loads. These effects were unique, since they were not observed with CaAc. In Stage 3 CKD, neither of the regimens have any effect. These metabolic changes suggest that EffCaMgCit might be useful in protecting against cardiovascular complications of CKD by ameliorating pathobiologic intermediates.",2019,"Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


","['Nine patients with Stage 3 and nine patients with Stage 5D CKD', 'chronic kidney disease (CKD']","['effervescent calcium magnesium citrate', 'conventional phosphorus binder calcium acetate (CaAc', 'effervescent calcium magnesium citrate (EffCaMgCit']","['serum parathyroid hormone', 'plasma citrate', 'serum Mg and phosphate', 'serum phosphorus', 'serum bicarbonate', 'EffCaMgCit nor CaAc altered T50']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0717537', 'cui_str': 'calcium acetate'}, {'cui': 'C0642815', 'cui_str': 'CAAC'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0642815', 'cui_str': 'CAAC'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",9.0,0.040943,"Only EffCaMgCit significantly increased serum bicarbonate by 3 mM (P = 0.015) in Stage 5D.
CONCLUSIONS


","[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Quiñones', 'Affiliation': 'Divisions of Nephrology, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. henry.quinones@utsouthwestern.edu.'}, {'ForeName': 'Tamim', 'Initials': 'T', 'LastName': 'Hamdi', 'Affiliation': 'Divisions of Nephrology, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Sakhaee', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pasch', 'Affiliation': 'Calciscon, Nidau-Biel, Switzerland.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Charles Y C', 'Initials': 'CYC', 'LastName': 'Pak', 'Affiliation': 'Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Journal of nephrology,['10.1007/s40620-018-0559-2']
826,31397184,"Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD.","Objectives:  The bronchodilator efficacy of a once-daily fixed-dose combination of tiotropium/formoterol (18/12 µg administered via a dry-powder inhaler, Discair) [TIO/FORM fixed  group] vs a single-dose of tiotropium (18 µg) by Handihaler 1  alone [TIO mono  group], or combined with formoterol 12 µg twice-daily by Aerolizer 2  [TIO/FORM bid  group] was compared in patients with moderate-to-severe stable COPD. Methods:  COPD patients were randomized (28 patients/group) to receive TIO/FORM fixed , TIO mono ,  or TIO/FORM bid . AUC for the changes in FEV 1  and FVC over a 24-h period; bronchodilator response (100 ml improvement in FEV 1 ) in the first 30 min; maximum changes in FEV 1  and FVC; and safety data were recorded. The primary endpoint was to confirm the non-inferiority of TIO/FORM fixed  vs TIO/FORM bid  in terms of the AUC for the changes in FEV 1  over a 24-h period. Results:  Changes in AUC 0-24h  for FEV 1  and FVC were similar for TIO/FORM fixed  and TIO/FORM bid , and were superior to TIO mono  ( p  < 0.001). A positive bronchodilator response at 30 min was demonstrated in 50%, 64%, and 71% of patients in the TIO mono , TIO/FORM bid , and TIO/FORM fixed  groups, respectively (NS). Maximum FEV 1  and FVC changes were measured as 0.25/0.41 L, 0.32/0.49 L, and 0.37/0.53 L, for TIO mono , TIO/FORM bid , and TIO/FORM fixed , respectively (FEV 1 : TIO/FORM fixed  vs TIO mono ,  p  = 0.0017 and TIO/FORM fixed  vs TIO/FORM bid ,  p  = 0.4846); no differences were recorded between the combination groups. Conclusions:  The 24-h bronchodilator efficacy of TIO/FORM fixed  18/12 µg once-daily by Discair 3  was non-inferior to a combination of tiotropium 18 µg by Handihaler plus formoterol 12 µg twice-daily by Aerolizer, and superior to tiotropium 18 µg monotherapy by Handihaler.",2019,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid  and TIO/FORM fixed  groups, respectively (NS).","['adults with moderate-to-severe stable COPD', 'COPD patients']","['tiotropium/formoterol', 'tiotropium', 'TIO/FORM fixed , TIO mono  or TIO/FORM bid ', 'tiotropium alone (18 µg by Handihaler®) or combined with formoterol', 'FVC', 'Discair®', 'Handihaler® alone [TIO mono  group], or combined with formoterol 12 µg twice-daily by Aerolizer']","['Bronchodilator efficacy', '24-h bronchodilator efficacy', 'bronchodilator efficacy', 'Maximum FEV 1  and FVC changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C2355432', 'cui_str': 'TiO(tpyp)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.180891,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid  and TIO/FORM fixed  groups, respectively (NS).","[{'ForeName': 'Birsen Pinar', 'Initials': 'BP', 'LastName': 'Yildiz', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Bayraktaroglu', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gunen', 'Affiliation': 'Department of Chest Diseases and Thoracic Surgery, Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Istanbul, Turkey.'}]",Current medical research and opinion,['10.1080/03007995.2019.1654722']
827,31418585,Abaloparatide in patients with mild or moderate renal impairment: results from the ACTIVE phase 3 trial.,"Objective:  To evaluate, post hoc, the efficacy and safety of abaloparatide by degree of renal impairment. Methods:  ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily. Patients with serum creatinine >2.0 mg/dL or 1.5-2.0 mg/dL with an estimated glomerular filtration rate (eGFR) <37 mL/min, calculated by Cockcroft-Gault formula, were excluded. Results:  At baseline, 660 patients had eGFR ≥90 mL/min, 1276 had 60 to ˂90 mL/min, and 527 had <60 mL/min. Older age and lower T-scores were associated with greater renal impairment. Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms. Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment. Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR <60 mL/min (3.6% versus 10.9%;  p  = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%;  p  = .006). Computed tomography scans in 376 patients revealed no evidence of increased renal calcification. Conclusion:  Increased exposure to abaloparatide and teriparatide in patients with renal impairment led to no meaningful differences in efficacy or safety. These results support the use of abaloparatide without dosage adjustment in patients with renal impairment, provided those with severe renal impairments are monitored for adverse events.",2019,"Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.","['patients with renal impairment', '376 patients', 'Patients with serum creatinine >2.0\u2009mg/dL or 1.5-2.0\u2009mg/dL with an estimated glomerular filtration rate (eGFR) <37\u2009mL/min, calculated by Cockcroft-Gault formula, were excluded', 'patients with mild or moderate renal impairment', 'postmenopausal women with osteoporosis who received']","['teriparatide', 'Abaloparatide', 'placebo', 'abaloparatide and teriparatide', 'subcutaneous abaloparatide 80\u2009µg, placebo, or open-label teriparatide 20\u2009µg daily', 'Computed tomography scans']","['efficacy or safety', 'Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection', 'bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events', 'renal calcification', 'renal impairment', 'Hypercalcemia measured by albumin-adjusted serum calcium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C2924627', 'cui_str': 'Cockcroft-Gault formula'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}]",660.0,0.224441,"Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bilezikian', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Mitlak', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dabrowski', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research at Panorama Orthopedics and Spine Center, Golden, CO, USA.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Leiden University Medical Center, Leiden, The Netherlands.'}]",Current medical research and opinion,['10.1080/03007995.2019.1656955']
828,30337697,"Preconditioning with fludarabine, busulfan and cytarabine versus standard BuCy2 for patients with acute myeloid leukemia: a prospective, randomized phase II study.","To compare the efficacy and toxicity of a novel regimen called FBA, consisting of fludarabine, busulfan, and cytarabine, with the standard BuCy2 regimen for younger adult patients with acute myeloid leukemia, we conducted a prospective randomized phase II study. Patients in complete remission were randomly assigned to receive either the FBA (n = 56) or the BuCy2 regimen (n = 55). The difference in 100-day transplant-related mortality (TRM) was not statistically significant between the two arms (1.79% for FBA versus 5.45% for BuCy2, P = 0.260), as were the cumulative incidences of relapse, TRM, overall survival (OS) and event-free survival (EFS) at 3 years. However, the 100-day cumulative incidences of grades II-IV and III-IV acute graft-versus-host disease (aGVHD) were lower in the FBA group [(8.93% versus 21.86%, P = 0.032) (1.79% versus 9.09%, P = 0.025)]. The 3-year GVHD and relapse-free survival (GRFS) was 31.20% for the FBA group and 14.96% for the BuCy2 group (P = 0.004). The incidences of diarrhea and severe oral mucositis within the first 30 days post-transplantation were lower in the FBA group [(28.57% versus 65.45%; P < 0.001) (51.79% versus 70.91%; P = 0.039)]. In conclusion, allogenic transplantation with the FBA regimen achieved similar TRM, relapse rate, OS and EFS, as that with the BuCy2 regimen but with less frequent and less severe complications in early stage after transplantation and a trend toward higher GRFS.",2019,The incidences of diarrhea and severe oral mucositis within the first 30 days post-transplantation were lower in the FBA group [(28.57% versus 65.45%; P < 0.001) (51.79% versus 70.91%; P = 0.039)].,"['younger adult patients with acute myeloid leukemia', 'patients with acute myeloid leukemia', 'Patients in complete remission']","['FBA', 'fludarabine, busulfan and cytarabine versus standard BuCy2', 'fludarabine, busulfan, and cytarabine, with the standard BuCy2 regimen', 'BuCy2 regimen']","['100-day transplant-related mortality (TRM', 'incidences of diarrhea and severe oral mucositis', 'cumulative incidences of relapse, TRM, overall survival (OS) and event-free survival (EFS', '3-year GVHD and relapse-free survival (GRFS', 'efficacy and toxicity', 'TRM, relapse rate, OS and EFS', 'severe complications', '100-day cumulative incidences of grades II-IV and III-IV acute graft-versus-host disease (aGVHD']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0677874', 'cui_str': 'In full remission (qualifier value)'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]",,0.0277045,The incidences of diarrhea and severe oral mucositis within the first 30 days post-transplantation were lower in the FBA group [(28.57% versus 65.45%; P < 0.001) (51.79% versus 70.91%; P = 0.039)].,"[{'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zi-Wei', 'Initials': 'ZW', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xian-Min', 'Initials': 'XM', 'LastName': 'Song', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Xia', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gu-Sheng', 'Initials': 'GS', 'LastName': 'Tang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yan-Rong', 'Initials': 'YR', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China. jmwangch@139.com.'}]",Bone marrow transplantation,['10.1038/s41409-018-0356-5']
829,31161241,"Femoral tunnel position in chronic anterior cruciate ligament rupture reconstruction: randomized controlled trial comparing anatomic, biomechanical and clinical outcomes.","PURPOSE


The aim of this study was to compare the outcomes between anteromedial (AM) and transtibial (TT) femoral tunnel positioning techniques for the reconstruction of chronic anterior cruciate ligament (ACL) rupture.
MATERIALS AND METHODS


It is a randomized prospective study of 106 patients who underwent ACL reconstruction because of a chronic ACL rupture (55 AMT, 51 TT). Minimum follow-up was 2 years. Demographic, clinical and radiological data, including MRI grafts' anatomy and biomechanics intraoperative navigation system evaluation, were analyzed. Also, International Knee Documentation Committee score, Tegner Knee score, Lysholm Knee Score, Short-Form Health Survey and 4-point Likert Scale were evaluated.
RESULTS


The AM technique achieves a more anatomic graft than TT technique in both sagittal and coronal plane (6° approximately). Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000). AMT showed superiority only in controlling internal rotation (p = 0.016). Both techniques reported significant improvement in all evaluated score scales, without differences between techniques. Independently of the femoral tunnel positioning technique, patients with cartilage lesion had worse clinical outcomes.
CONCLUSIONS


Our findings suggest that AMT achieves a more anatomical and biomechanically accurate graft allowing better control over internal rotation laxity; however, this does not lead to better clinical outcomes if we compare with TT in the reconstruction of chronic ACL rupture. Patients with chronic ACL rupture and cartilage lesion had worse clinical outcomes, independently the femoral tunnel positioning technique.",2019,Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000).,"['chronic anterior cruciate ligament (ACL) rupture', 'Patients with chronic ACL rupture and cartilage lesion', '106 patients who underwent ACL reconstruction because of a chronic ACL rupture (55 AMT, 51 TT', 'chronic anterior cruciate ligament rupture reconstruction']","['AMT', 'Femoral tunnel position', 'anteromedial (AM) and transtibial (TT) femoral tunnel positioning techniques']","['International Knee Documentation Committee score, Tegner Knee score, Lysholm Knee Score, Short-Form Health Survey and 4-point Likert Scale', 'translational and rotational laxity']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}]",106.0,0.0457269,Immediate postoperative biomechanical evaluation of the graft showed both techniques significantly improved translational and rotational laxity (p = 0.000).,"[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Minguell', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'Jorge H', 'Initials': 'JH', 'LastName': 'Nuñez', 'Affiliation': 'Knee and Spine Unit, Department of Traumatology and Orthopedic Surgery, University Hospital of Mutua Terrassa (DNR), Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain. hassan2803med@gmail.com.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Reverte-Vinaixa', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sallent', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gargallo-Margarit', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castellet', 'Affiliation': ""Knee Unit, Department of Traumatology and Orthopaedic Surgery, University Hospital of Vall d' Hebron, Universitat Autónoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain.""}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02455-x']
830,31757656,"Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial.","BACKGROUND


Laparoscopy-assisted distal gastrectomy (LADG) is increasingly being used as an alternative to open distal gastrectomy (ODG) for gastric cancer treatment. Retrospective studies have shown equivalent survival with the two procedures, but these studies are limited by selection bias because LADG is more technically difficult than ODG. We aimed to evaluate whether LADG was non-inferior to ODG in terms of long-term survival outcomes.
METHODS


We did an open-label, multicentre, non-inferiority, phase 3 randomised controlled trial at 33 institutions in Japan. Patients aged 20-80 years with histologically confirmed gastric adenocarcinoma (T1N0, T1N1, or T2[MP]N0), clinical stage I, in the middle or lower third of the stomach, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a body-mass index of less than 30 kg/m 2 , were randomly assigned (1:1) to receive ODG or LADG. Randomisation was done by telephone, fax, or with a web-based system in the Japan Clinical Oncology Group Data Center; a minimisation method with a random component was used to adjust for institution and clinical stage (IA or IB). Only study-accredited surgeons performed ODG and LADG. The primary endpoint was relapse-free survival and was analysed according to the intention-to-treat principle. The non-inferiority margin (LADG vs ODG) was set at a hazard ratio (HR) of 1·54. The trial was registered with the UMIN Clinical Trials Registry, UMIN000003319.
FINDINGS


Between March 15, 2010, and Nov 29, 2013, 921 patients were enrolled and randomly assigned to receive ODG (n=459) or LADG (n=462). 912 (99%) participants had the assigned surgery. 5-year relapse-free survival was 94·0% (95% CI 91·4-95·9) in the ODG group and 95·1% (92·7-96·8) in the LADG group. LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075). The most common grade 3 or 4 adverse event was bowel obstruction, occurring in 11 (2%) of 455 patients in the ODG group and five (1%) of 457 patients in the LADG group. There were no treatment-related deaths.
INTERPRETATION


This trial supports the non-inferiority of LADG compared with ODG for clinical stage I gastric cancer relapse-free survival, suggesting that LADG should be considered a standard treatment option when performed by experienced surgeons.
FUNDING


Japan National Cancer Center, Ministry of Health, Labour and Welfare of Japan, Japan Agency for Medical Research and Development.",2020,"LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075).","['Patients aged 20-80 years with histologically confirmed gastric adenocarcinoma (T1N0, T1N1, or T2[MP]N0), clinical stage I, in the middle or lower third of the stomach, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a body-mass index of less than 30 kg/m 2', '912 (99%) participants had the assigned surgery', '33 institutions in Japan', 'Between March 15, 2010, and Nov 29, 2013, 921 patients']","['ODG', 'laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection', 'LADG', 'Laparoscopy-assisted distal gastrectomy (LADG', 'ODG or LADG']","['Survival outcomes', '5-year relapse-free survival', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",921.0,0.318253,"LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075).","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Katai', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan. Electronic address: hkatai@ncc.go.jp.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Bando', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Teshima', 'Affiliation': 'Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Koeda', 'Affiliation': 'Department of Surgery, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Souya', 'Initials': 'S', 'LastName': 'Nunobe', 'Affiliation': 'Department of Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30332-2']
831,31128959,Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT.,"INTRODUCTION


Colorectal cancer screening (CRCS) remains underutilized. Decision aids (DAs) can increase patient knowledge, intent, and CRCS rates compared with ""usual care,"" but whether interactivity further increases CRCS rate remains unknown.
STUDY DESIGN


A two-armed RCT compared the effect of a web-based DA that interactively assessed patient CRC risk and clarified patient preference for specific CRCS test to a web-based DA with the same content but without the interactive tools.
SETTING/PARTICIPANTS


The study sites were 12 community- and three university-based primary care practices (56 physicians) in southeastern Michigan. Participants were men and women aged 50-75 years not current on CRCS.
INTERVENTION


Random allocation to interactive DA (interactive arm) or non-interactive DA (non-interactive arm).
MAIN OUTCOME MEASURES


Primary outcome was medical record documentation of CRCS 6 months after the intervention. Secondary outcome was patient decision quality (i.e., knowledge, preference clarification, and intent) measured immediately before and after DA use, and immediately after the office visit. To determine that either DA had a positive effect on CRCS adherence, usual care CRCS rates were determined from the three university-based practices among patients eligible for but not participating in the study.
RESULTS


Data were collected between 2012 and 2014; analysis began in 2015. At 6 months, CRCS rate was 36.1% (95% CI=30.5%, 42.2%) in the interactive arm (n=284) and 40.5% (95% CI=34.7%, 46.6%) in the non-interactive arm (n=286, p=0.29). Usual care CRCS rate (n=440) was 18.6% (95% CI=15.2%, 22.7%), significantly lower than both arms (p<0.001). Knowledge, attitude, self-efficacy, test preference, and intent increased significantly within each arm versus baseline, but the rate was not significantly different between the two arms.
CONCLUSIONS


The interactive DA did not improve the outcome compared to the non-interactive DA. This suggests that the resources needed to create and maintain the interactive components are not justifiable.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01514786.",2019,"Usual care CRCS rate (n=440) was 18.6% (95% CI=15.2%, 22.7%), significantly lower than both arms (p<0.001).","['Participants were men and women aged 50-75 years not current on CRCS', 'Data were collected between 2012 and 2014; analysis began in 2015', 'The study sites were 12 community- and three university-based primary care practices (56 physicians) in southeastern Michigan']","['Decision aids (DAs', 'DA', 'Random allocation to interactive DA (interactive arm) or non-interactive DA (non-interactive arm']","['medical record documentation of CRCS 6 months', 'patient decision quality (i.e., knowledge, preference clarification, and intent', 'CRCS adherence, usual care CRCS rates', 'Knowledge, attitude, self-efficacy, test preference', 'Usual care CRCS rate', 'CRCS rate']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.177609,"Usual care CRCS rate (n=440) was 18.6% (95% CI=15.2%, 22.7%), significantly lower than both arms (p<0.001).","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Jimbo', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan; Department of Biostatistics, University of Michigan, Ann Arbor, Michigan. Electronic address: anandas@umich.edu.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Plegue', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hawley', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly-Blake', 'Affiliation': 'Center for Ethics and Humanities in the Life Sciences and Department of Medicine, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rapai', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Minling', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Kidney Epidemiology and Cost Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': 'Department of Family and Community Medicine, Penn State Health Milton S. Hershey Medical Center, Penn State College of Medicine, Hershey, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.03.004']
832,31397597,"Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study.","Objectives:  Many women experience menstrual cramps, which adversely affects quality-of-life. Both naproxen and acetaminophen are indicated to relieve menstrual pain. This study assessed the analgesic efficacy of a single, maximum non-prescription dose of naproxen sodium compared with that of acetaminophen in the treatment of primary dysmenorrhea. Methods:  Healthy females with primary dysmenorrhea were included in our double-blind, randomized, crossover study (trial registration no. NCT03448536). When pain was moderate (≥5 on 0-10 numerical rating scale), subjects took a single dose of naproxen sodium (440 mg) and crossed over to acetaminophen (1000 mg) in the next cycle, or vice versa. Total pain relief over 12 h (TOTPAR0-12) was the primary outcome, while secondary outcomes included summed pain intensity differences (SPID) and TOTPAR scores throughout 12 h, and subject overall evaluation of treatment. Results:  The per protocol population ( n  = 189) used naproxen sodium ( n  = 170) and acetaminophen ( n  = 160). TOTPAR0-12 was significantly greater with naproxen sodium than acetaminophen (least-squares (LS) mean difference = 4.31;  p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001). Some measures of pain intensity favoring naproxen sodium became significant at earlier time points (e.g. SPID4-6 LS mean difference = 1.49;  p  = .02). After 6 h post-dose, naproxen sodium was significantly more effective than acetaminophen, maintained for 12 h (SPID6-12 LS mean difference = 8.27; TOTPAR6-12 LS mean difference = 3.75; both  p  < .001). Significantly more subjects rated naproxen sodium as good-to-excellent (70.6%) vs acetaminophen (63.1%) ( p  = .002). Conclusions:  A single, maximum non-prescription dose of naproxen sodium was more effective than acetaminophen over 12 h.",2019,"p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001).","['primary dysmenorrhea', 'Healthy females with primary dysmenorrhea']","['naproxen sodium', 'acetaminophen', 'naproxen and acetaminophen', 'acetaminophen (least-squares (LS']","['pain intensity', 'Total pain relief', 'menstrual pain', 'summed pain intensity differences (SPID) and TOTPAR scores throughout 12\u2009h, and subject overall evaluation of treatment', 'analgesic efficacy']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.49797,"p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Daniels', 'Affiliation': 'Independent Consultant.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paredes-Diaz', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'An', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Centofanti', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1654987']
833,31141115,Comparison of Cinematic Rendering and Computed Tomography for Speed and Comprehension of Surgical Anatomy.,"Importance


Three-dimensional (3-D) volume rendering has been shown to improve visualization in general surgery. Cinematic rendering (CR), a novel 3-D visualization technology for postprocessing of computed tomographaphy (CT) images, provides photorealistic images with the potential to improve visualization of anatomic details.
Objective


To determine the value of CR for the comprehension of the surgical anatomy.
Design, Setting, and Participants


This preclinical, randomized, 2-sequence crossover study was conducted from February to November 1, 2018, at University Hospital of Erlangen, Germany. The 40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images. The patient cases were randomized to 2 assessment sequences (CR-CT and CT-CR). During each assessment period, participants answered 1 question per case that addressed crucial issues of anatomic understanding, preoperative planning, and intraoperative strategies. After a washout period of 2 weeks, case evaluations were crossed over to the respective second image modality.
Main Outcomes and Measures


The primary outcome measure was the correctness of answers. Secondary outcome was the time needed to answer.
Results


The mean (SD) interperiod differences for the percentage of correct answers in the CR-CT sequence (8.5% [7.0%]) differed significantly from those in the CT-CR sequence (-13.1% [6.3%]) (P < .001). The mean (SD) interperiod differences for the time spent to answer the questions in the CR-CT sequence (-18.3 [76.9] seconds) also differed significantly from those in the CT-CR sequence (52.4 [88.5] seconds) (P < .001). Subgroup analysis revealed that residents as well as attending physicians benefitted from CR visualization. Analysis of the case assessment questionnaire showed that CR added significant value to the comprehension of the surgical anatomy (overall mean [SD] score, 4.53 [0.75]). No carryover or period effects were observed.
Conclusions and Relevance


The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience. Therefore, CR may assist general surgeons with preoperative preparation and intraoperative guidance.",2019,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","['February to November 1, 2018, at University Hospital of Erlangen, Germany', '40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images']","['Cinematic Rendering and Computed Tomography', 'Cinematic rendering (CR']","['CR-CT sequence', 'correctness of answers', 'time needed to answer']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.0666622,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","[{'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Elshafei', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Binder', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Baecker', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Institute of Radiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.1168']
834,31548244,Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial.,"OBJECTIVE


In type 2 diabetes, insulin resistance and progressive β-cell failure require treatment with high insulin doses, leading to weight gain. Our aim was to study whether a three-meal diet (3Mdiet) with a carbohydrate-rich breakfast may upregulate clock gene expression and, as a result, allow dose reduction of insulin, leading to weight loss and better glycemic control compared with an isocaloric six-meal diet (6Mdiet).
RESEARCH DESIGN AND METHODS


Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2  and HbA 1c  8.1 ± 1.1% [64.5 ± 11.9 mmol/mol]) were randomly assigned to 3Mdiet or 6Mdiet. Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression were assessed at baseline, after 2 weeks, and after 12 weeks.
RESULTS


3Mdiet, but not 6Mdiet, led to a significant weight loss (-5.4 ± 0.9 kg) ( P  < 0.01) and decreased HbA 1c  (-12 mmol/mol [-1.2%]) ( P  < 0.0001) after 12 weeks. Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet. CGM showed a significant decrease in the time spent in hyperglycemia only on the 3Mdiet. Total daily insulin dose was significantly reduced by 26 ± 7 units only on the 3Mdiet. There was a significant decrease in the hunger and cravings only in the 3Mdiet group. Clock genes exhibited oscillation, increased expression, and higher amplitude on the 3Mdiet compared with the 6Mdiet.
CONCLUSIONS


A 3Mdiet, in contrast to an isocaloric 6Mdiet, leads to weight loss and significant reduction in HbA 1c , appetite, and overall glycemia, with a decrease in daily insulin. Upregulation of clock genes seen in this diet intervention could contribute to the improved glucose metabolism.",2019,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"['Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2  and HbA 1c  8.1 ± 1.1% [64.5 ± 11.9 mmol/mol', 'Patients With Type']","['3Mdiet or 6Mdiet', 'isocaloric six-meal diet (6Mdiet', 'meal diet (3Mdiet) with a carbohydrate-rich breakfast', 'CGM']","['time spent in hyperglycemia', 'weight loss, significant reduction in HbA 1c , appetite, and overall glycemia', 'Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression', 'glucose metabolism', 'Fasting glucose and daily and nocturnal glucose levels', 'Total daily insulin dose', 'hunger and cravings', 'weight loss', 'daily insulin', 'Glycated Hemoglobin and Daily Insulin Dose']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",28.0,0.0205284,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Jakubowicz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel daniela.jak@gmail.com.'}, {'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Landau', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Tsameret', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ahren', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Chapnik', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Barnea', 'Affiliation': 'Department of Molecular Genetics, Faculty of Biochemistry, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Ganz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menaged', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Mor', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Yosefa', 'Initials': 'Y', 'LastName': 'Bar-Dayan', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel oren.froy@mail.huji.ac.il.'}]",Diabetes care,['10.2337/dc19-1142']
835,31115060,Validity of a questionnaire developed to measure the impact of a high-fidelity simulation intervention: A feasibility study.,"AIM


To evaluate the validity and responsiveness of a questionnaire developed to measure the impact of a high-fidelity simulation intervention.
DESIGN


A pre- and postintervention design.
METHODS


In August 2017, 107 participants completed a questionnaire measuring knowledge and perceived self-confidence pre- and postintervention. Validity of the questionnaire was determined by expert reviews, individual interviews and estimates of the changes in knowledge and perceived self-confidence. The changes were estimated by the differences between paired proportions of participants. The responsiveness of the ordered categorical item scores on self-confidence was evaluated by the measure of systematic group change and individual variations.
RESULTS


The analysis of the interviews resulted in three themes: item content, item style and the administration of the questionnaire. An intervention effect on knowledge assessments was shown by the changes in paired proportions of participants with increased or decreased correct assessments (ranging from -25.5 - 24.8 percentage units). The responsiveness of the self-confidence scale was confirmed by evidence of post-intervention systematic group changes towards higher levels.
CONCLUSION


This study provides useful experience for a forthcoming randomized controlled study to evaluate the effect of high-fidelity simulation on undergraduate nursing students' knowledge and self-confidence when assessing patient deterioration.
IMPACT


Cause-and-effect relationship between simulation and learning is required to improve nursing education. A statistically significant rise in students' knowledge and levels of self-confidence after simulation were identified in this study. The study provided important aspects of future research study designs.",2019,"The responsiveness of the self-confidence scale was confirmed by evidence of post-intervention systematic group changes toward higher levels.
","['undergraduate nursing students', 'In August 2017, 107 participants completed a questionnaire measuring knowledge and perceived self-confidence pre-and post-intervention']","['High-Fidelity Simulation Intervention', 'high-fidelity simulation']","['knowledge and self-confidence', ""students' knowledge and levels of self-confidence"", 'knowledge assessments', 'responsiveness of the self-confidence scale']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}]",,0.0777862,"The responsiveness of the self-confidence scale was confirmed by evidence of post-intervention systematic group changes toward higher levels.
","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Haddeland', 'Affiliation': 'Faculty of Health and Sports Sciences, Centre for Caring Research - Southern Norway, University of Agder, Agder, Norway.'}, {'ForeName': 'Åshild', 'Initials': 'Å', 'LastName': 'Slettebø', 'Affiliation': 'Faculty of Health and Sports Sciences, Centre for Caring Research - Southern Norway, University of Agder, Agder, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Svensson', 'Affiliation': 'Department of Statistics, Swedish Business School at Örebro University, Örebro, Sweden.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carstens', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Fossum', 'Affiliation': 'Faculty of Health and Sports Sciences, Centre for Caring Research - Southern Norway, University of Agder, Agder, Norway.'}]",Journal of advanced nursing,['10.1111/jan.14077']
836,30977520,Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials.,"OBJECTIVE


Presentation of pooled analysis of safety data for fremanezumab in patients with chronic (CM) or episodic migraine (EM) from 4 placebo-controlled phase 2b and phase 3 studies.
BACKGROUND


There is a need for an effective, safe, and well-tolerated preventive therapy that specifically targets the pathophysiology of migraine to reduce the frequency and severity of migraine attacks in patients with CM or EM who experience 4 or more migraine days per month. Fremanezumab is a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, a neuropeptide involved in the pathophysiology of migraine.
DESIGN/METHODS


The 4 placebo-controlled phases 2b and 3 studies included in this analysis were 16-week, multicenter, randomized, double-blind, placebo-controlled, and parallel-group studies consisting of a screening visit, a 28-day pretreatment baseline period, and a 12-week treatment period with a final evaluation 4 weeks after the final dose of the study drug. Safety endpoints included adverse events (AEs) and immunogenicity.
RESULTS


A total of 2566 patients were randomized across all studies (fremanezumab, n = 1704; placebo, n = 862), and 2563 patients were treated. Common reasons for study discontinuation were withdrawal by patient (n = 78), patient lost to follow-up (n = 60), and AE (n = 50). The mean (standard deviation) duration of exposure was 83.8 (13.6) days for the patients who received fremanezumab, with a total exposure of 390.4 patient years and maximum exposure of 181 days. AEs were mostly mild to moderate in severity and were reported among 48-69% of patients in all treatment groups, and most were injection site reactions (pain, induration, and erythema). Two deaths occurred (chronic obstructive pulmonary disease and intentional overdose of diphenhydramine), both of which were deemed unrelated to study drug by the investigators and sponsor. Cardiovascular adverse events, abnormal liver function tests, and hypersensitivity were uncommon and occurred at similar rates between the placebo and fremanezumab groups.
CONCLUSIONS


Fremanezumab is a generally safe and well-tolerated preventive therapy for migraine in adults.",2019,"Cardiovascular adverse events, abnormal liver function tests, and hypersensitivity were uncommon and occurred at similar rates between the placebo and fremanezumab groups.
","['Migraine', 'A total of 2566 patients were randomized across all studies (fremanezumab, n\xa0=\xa01704; placebo, n\xa0=\xa0862), and 2563 patients were treated', 'migraine in adults', 'patients with chronic (CM) or episodic migraine (EM) from 4 placebo-controlled phase 2b and phase 3 studies']","['fremanezumab', 'Fremanezumab', 'placebo', 'diphenhydramine']","['injection site reactions (pain, induration, and erythema', 'Safety and Tolerability', 'Cardiovascular adverse events, abnormal liver function tests, and hypersensitivity', 'mean (standard deviation) duration of exposure', 'adverse events (AEs) and immunogenicity']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332534', 'cui_str': 'Induration (morphologic abnormality)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151766', 'cui_str': 'Abnormal results of liver function studies'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",2566.0,0.326592,"Cardiovascular adverse events, abnormal liver function tests, and hypersensitivity were uncommon and occurred at similar rates between the placebo and fremanezumab groups.
","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, CT, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Faulhaber', 'Affiliation': 'Ratiopharm GmbH, Ulm, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lang', 'Affiliation': 'Ratiopharm GmbH, Ulm, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schiemann', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Aycardi', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Janka', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Pharmaceuticals, Frazer, PA, USA.'}]",Headache,['10.1111/head.13534']
837,31985471,"Baseline Variables Associated with Functional Decline in 2CARE, A Randomized Clinical Trial in Huntington's Disease.","BACKGROUND


Despite the clearly recognized progressive functional decline of Huntington's disease (HD), detailed investigations of factors associated with the rate of functional progression are limited.
OBJECTIVE


Understanding factors associated with functional decline through examination of existing HD clinical databases may improve efforts to mitigate it.
METHODS


We analyzed data from 2CARE, a randomized clinical trial with up to 5 years of follow-up, to assess potential risk factors for more rapid functional decline in HD.
RESULTS


Variables associated with faster functional decline included worse motor performance, worse cognitive test scores, female sex, lower weight and body mass index, and a higher CAG repeat length, especially in younger people.
CONCLUSION


While our data are limited to the structured environment and homogeneity of a clinical trial, attention to several of the identified risk factors may be useful towards managing functional decline over time. The observation that women progress faster than men, while potentially confounded by an association between sex and weight, deserves further study.",2020,"RESULTS


Variables associated with faster functional decline included worse motor performance, worse cognitive test scores, female sex, lower weight and body mass index, and a higher CAG repeat length, especially in younger people.
",['2CARE'],[],"['motor performance, worse cognitive test scores, female sex, lower weight and body mass index']",[],[],"[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.14675,"RESULTS


Variables associated with faster functional decline included worse motor performance, worse cognitive test scores, female sex, lower weight and body mass index, and a higher CAG repeat length, especially in younger people.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Cooper University Healthcare at Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McDermott', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kieburtz', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Huntington's disease,['10.3233/JHD-190391']
838,31618056,Effects of Transcranial Direct Current Stimulation on Apraxia of Speech and Cortical Activation in Patients With Stroke: A Randomized Sham-Controlled Study.,"Purpose The study aims to investigate, using anodal transcranial direct current stimulation (A-tDCS), over which site, the left lip region of primary motor cortex (M1) or the Broca's area, there would be better recovery from apraxia of speech (AoS) in patients with poststroke aphasia and to examine for altered activation in speech-related areas after tDCS with nonlinear electroencephalography (EEG). Method Fifty-two patients with AoS were randomized into A-tDCS over the left M1 (A-tDCS-M1), Broca's area, and sham tDCS groups who underwent 10 sessions of tDCS and speech treatment for 5 days. The EEG nonlinear index of approximate entropy was calculated for 6 subjects in each group before and after treatment. Results After treatment, the change in speech-language performance improved more significantly in the A-tDCS-M1 group than the other 2 groups ( p  < .05). EEG approximate entropy indicated that both A-tDCS groups could activate the stimulated sites; the improvement in the A-tDCS-M1 group was correlated with high activation in the dorsal lateral prefrontal cortex and Broca's areas of the left hemisphere in addition to the stimulated site. Conclusion A-tDCS over the left M1 can improve the speech function in patients with poststroke aphasia and severe AoS and excite and recruit more areas in the motor speech network.",2019,"After treatment, the change in speech-language performance improved more significantly in the A-tDCS-M1 group than the other 2 groups ( p  < .05).","['Patients With Stroke', 'patients with poststroke aphasia and to examine for altered activation in speech-related areas after tDCS with nonlinear electroencephalography (EEG', 'Method Fifty-two patients with AoS']","['Transcranial Direct Current Stimulation', 'anodal transcranial direct current stimulation (A-tDCS']","['EEG nonlinear index of approximate entropy', 'speech function', 'change in speech-language performance', 'Apraxia of Speech and Cortical Activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0332128', 'cui_str': 'Examined for (contextual qualifier) (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0264611', 'cui_str': 'Apraxia of Phonation'}]",,0.024152,"After treatment, the change in speech-language performance improved more significantly in the A-tDCS-M1 group than the other 2 groups ( p  < .05).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Wangjing Hospital of China Academy of Chinese Medical Science, Beijing, China.'}, {'ForeName': 'Dongyu', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Wangjing Hospital of China Academy of Chinese Medical Science, Beijing, China.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiqun', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Wangjing Hospital of China Academy of Chinese Medical Science, Beijing, China.'}, {'ForeName': 'Dahua', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine Oncology, Affiliated Tumor Hospital of Zhengzhou University, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Health Care, Zunyi Academician Center, China.'}]",American journal of speech-language pathology,['10.1044/2019_AJSLP-19-0069']
839,31086287,The role of recombinant human CC10 in the prevention of chronic pulmonary insufficiency of prematurity.,"BACKGROUND


Preterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP.
METHODS


The safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA.
RESULTS


With CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA.
CONCLUSIONS


A single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.",2019,no significant differences were observed between rhCC10 or placebo groups.,"['CPIP at 12 months corrected gestational age (CGA', 'high-risk premature neonates', 'Eighty-eight neonates', 'chronic pulmonary insufficiency of prematurity']","['rhCC10', 'placebo', 'Recombinant human CC10 protein (rhCC10', 'recombinant human CC10', 'placebo and 23 to 5\u2009mg/kg rhCC10']","['signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications', 'safety and efficacy']","[{'cui': 'C0072300', 'cui_str': 'cyclic PIP'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0456012', 'cui_str': 'Chronic pulmonary insufficiency of prematurity (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1505089', 'cui_str': 'secretoglobin, family 1A, member 1 (uteroglobin) protein, human'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.39498,no significant differences were observed between rhCC10 or placebo groups.,"[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA. jdavis@tuftsmedicalcenter.org.'}, {'ForeName': 'Aprile L', 'Initials': 'AL', 'LastName': 'Pilon', 'Affiliation': 'Therabron Therapeutics, Inc, Rockville, MD, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Shenberger', 'Affiliation': ""Baystate Children's Hospital, Springfield, MA, USA.""}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'Breeze', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Terrin', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mazela', 'Affiliation': 'Ginekologiczno-Położniczy Szpital Kliniczny UM, Poznan, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Gulczynska', 'Affiliation': 'Instytut Centrum Zdrowia Matki Polski, Lodz, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parad', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",Pediatric research,['10.1038/s41390-019-0419-3']
840,31454258,Language Comprehension After Mild Traumatic Brain Injury: The Role of Speed.,"Purpose The aim of this study was to characterize language comprehension in mild traumatic brain injury (mTBI) by testing a speed-based hypothesis. We hypothesized that adults with mTBI would perform worse than a group of adults with orthopedic injuries (OIs) on an experimental language comprehension task. Method The study employed a prospective experimental design. Participants were 19 adults with mTBI and 19 adults with OI ages 18-55 years. Participants completed the  Whatdunit  task, a sentence agent selection task in speeded and unspeeded conditions. Results In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group. In the speeded condition, the mTBI group performed with lower accuracy than the OI group; however, this difference did not reach statistical significance. There was a marginally significant interaction of Sentence Type × Group for reaction time in the speeded condition. Conclusions While our task might have been sensitive to cognitive processing abilities in both groups (as evidenced by the main effects of condition and sentence type), the task was not specific enough to capture mTBI-related deficits. The similarities in performance between both groups have clinical implications for the treatment of not just brain-related trauma but also trauma in general.",2019,"In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group.","['Participants were 19 adults with mTBI and 19 adults with OI ages 18-55 years', 'After Mild Traumatic Brain Injury', 'adults with mTBI', 'mild traumatic brain injury (mTBI']",[],['Language Comprehension'],"[{'cui': 'C0386744', 'cui_str': 'AM19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]",[],"[{'cui': 'C0233733', 'cui_str': 'Language comprehension, function (observable entity)'}]",19.0,0.0333262,"In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group.","[{'ForeName': 'Rocío S', 'Initials': 'RS', 'LastName': 'Norman', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'Berbee Walsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin-Madison.'}, {'ForeName': 'Lyn S', 'Initials': 'LS', 'LastName': 'Turkstra', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}]",American journal of speech-language pathology,['10.1044/2019_AJSLP-18-0203']
841,31099033,Possibility of a risk-adapted treatment strategy for untreated aggressive adult T-cell leukaemia-lymphoma (ATL) based on the ATL prognostic index: a supplementary analysis of the JCOG9801.,"JCOG9801, a randomized phase III trial, reported that vincristine, cyclophosphamide, doxorubicin and prednisone (VCAP); doxorubicin, ranimustine and prednisone (AMP); and vindesine, etoposide, carboplatin and prednisone (VECP) (VCAP-AMP-VECP; mLSG15) showed superior clinical outcomes when compared to cyclophosphamide, doxorubicin, vincristine and prednisone every 2 weeks (CHOP-14; mLSG19) in patients with untreated aggressive adult T-cell leukaemia-lymphoma (ATL). To identify patients who require VCAP-AMP-VECP, we conducted a supplementary analysis of JCOG9801. Overall, 105 patients were included and categorized into low- (n = 44), intermediate- (n = 54) and high-risk (n = 7) groups according to the age-adjusted ATL prognostic index (ATL-PI). We excluded the high-risk group due to small numbers of patients. VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04). Better OS was observed in the intermediate-risk group treated with VCAP-AMP-VECP (hazard ratio: 0·65; 95% confidence interval: 0·36-1·19). In the intermediate-risk group, the VCAP-AMP-VECP arm showed higher complete response rates than the CHOP-14 arm (44·0% vs. 13·8%). The VCAP-AMP-VECP arm in both risk groups exhibited grade 4 thrombocytopenia, while grade 4 neutropenia was only observed in the intermediate-risk group. VCAP-AMP-VECP remains suitable for the intermediate-risk group, whereas its benefits appear modest in the low-risk group.",2019,VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04).,"['untreated aggressive adult T-cell leukaemia-lymphoma (ATL', 'patients who require VCAP-AMP-VECP', 'patients with untreated aggressive adult T-cell leukaemia-lymphoma (ATL', '105 patients were included and categorized into low']","['VCAP-AMP-VECP', 'vincristine, cyclophosphamide, doxorubicin and prednisone (VCAP); doxorubicin, ranimustine and prednisone (AMP); and vindesine, etoposide, carboplatin and prednisone (VECP) (VCAP-AMP-VECP; mLSG15', 'JCOG9801', 'cyclophosphamide, doxorubicin, vincristine and prednisone every 2\xa0weeks (CHOP-14; mLSG19']","['Better OS', 'grade 4 thrombocytopenia, while grade 4 neutropenia', 'complete response rates', 'overall survival (OS']","[{'cui': 'C0023493', 'cui_str': 'ATLL'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0243666', 'cui_str': 'ranimustine'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",105.0,0.0402397,VCAP-AMP-VECP did not show any superior trend for overall survival (OS) in the low-risk group (hazard ratio: 1·04; 95% confidence interval: 0·54-2·04).,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Hematology, Rheumatology and Infectious Diseases, Faculty of Life Sciences, Kumamoto University of Medicine, Kumamoto, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, International Medical Centre, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kadota', 'Affiliation': 'Japan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Fukushima', 'Affiliation': 'Laboratory of Hematoimmunology, School of Health Sciences, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishitsuka', 'Affiliation': 'Department of Hematology and Immunology, Kagoshima University Hospital, Kagoshima, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Centre, Nagoya, Japan.'}]",British journal of haematology,['10.1111/bjh.15950']
842,31727361,Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy.,"PURPOSE


The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy.
METHODS


This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups.
FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074).
IMPLICATIONS


Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.",2019,"FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017).",['Patients who had hypercholesterolemia and required lipid-lowering treatment'],"['rosuvastatin 5\xa0mg (R5, n\xa0=\xa068), rosuvastatin 10\xa0mg (R10, n\xa0=\xa067), rosuvastatin 20\xa0mg (R20, n\xa0=\xa069), and ezetimibe 10\xa0mg combined with rosuvastatin 5\xa0mg (R5\xa0+\xa0E10, n\xa0=\xa067), rosuvastatin 10\xa0mg (R10\xa0+\xa0E10, n\xa0=\xa068), and rosuvastatin 20\xa0mg (R20\xa0+\xa0E10, n\xa0=\xa068) daily', 'ezetimibe and low- or intermediate-intensity statin therapy', 'Ezetimibe combined with low- or intermediate-intensity statin therapy', 'rosuvastatin', 'ezetimibe', 'Ezetimibe and Rosuvastatin']","['LDL levels', 'total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C', 'LDL-C levels', 'lipid parameters and the target achievement rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0368695', 'cui_str': 'Apolipoprotein B/A1 (substance)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.0273947,"FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017).","[{'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Kyung-Jin', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Medical Center, Ewha Womans University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Won', 'Initials': 'YW', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Department of Internal Medicine, Medical College, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Choong-Hwan', 'Initials': 'CH', 'LastName': 'Kwak', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Republic of Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Cardiology Division, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Taek-Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Namho', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Kyung', 'Initials': 'HK', 'LastName': 'Jeon', 'Affiliation': ""Department of Cardiovascular, Uijeongbu, Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Kyoo-Rok', 'Initials': 'KR', 'LastName': 'Han', 'Affiliation': 'Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Keon-Woong', 'Initials': 'KW', 'LastName': 'Moon', 'Affiliation': ""Cardiology Division, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Health Policy and Management, College of Health Science & Department of Public Health Science, Graduate School, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.010']
843,31085503,Procedural microvascular activation in long lesions treated with bioresorbable vascular scaffolds or everolimus-eluting stents: the PROACTIVE trial.,"AIMS


Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis.
METHODS AND RESULTS


Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups.
CONCLUSIONS


In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.",2020,"A significant difference was observed between the two groups in the primary endpoint of Δ cIMR (p= 0,04).",['Patients (n=66) undergoing'],"['everolimus-eluting bioresorbable vascular scaffold (BVS) or everolimus-eluting stent (EES', 'bioresorbable vascular scaffold versus everolimus-eluting stent implantation', 'BVS or EES', 'elective percutaneous coronary intervention (PCI']","['changes of pressure-derived corrected index of microvascular resistance (cIMR', 'high sensitivity-cardiac troponin T (hs-cTnT), platelet reactivity', 'microvascular ACTIVation', 'Hs-ADP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",66.0,0.10859,"A significant difference was observed between the two groups in the primary endpoint of Δ cIMR (p= 0,04).","[{'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Pellicano', 'Affiliation': 'Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Gioia', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ciccarelli', 'Affiliation': ''}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xaplanteris', 'Affiliation': ''}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Delrue', 'Affiliation': ''}, {'ForeName': 'Gabor G', 'Initials': 'GG', 'LastName': 'Toth', 'Affiliation': ''}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Van Durme', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Heyse', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wyffels', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vanderheyden', 'Affiliation': ''}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-01138']
844,31082829,"Cognitive Effects of Combined Amisulpride and Quetiapine Treatment in Patients With Refractory Schizophrenia: A Naturalistic, Prospective Study.","BACKGROUND


Regarding the treatment of patients with resistant schizophrenia, different options exit, although they are supported by limited evidence. In this study, antipsychotic polypharmacy, comprising 1200 mg of amisulpride and 600 mg of quetiapine, was used. Clinical change evaluation was performed using neurocognitive evaluations.
STUDY QUESTION


The use of amisulpride and quetiapine will imply a clinical improvement in patients affected by schizophrenia, which will be specially reflected in a cognitive improvement.
STUDY DESIGN


Naturalistic and prospective study. Twenty-six patients were applied and assessed by a battery of neurocognitive evaluations since the pretreatment baseline until 6-month treatment. The patients had no biological response to medication, high social maladjustment, and a long clinical history of the disease. Kane and Brenner criteria for treatment-resistant schizophrenia were applied to choose the subjects.
MEASURES AND OUTCOMES


The cognitive improvement will imply a significant betterment, from the pretreatment baseline until 6-month treatment, in the following cognitive tests: Stroop Test, WAIS Coding Subtest, and Comprehensive Trail Making Test (CTMT). An improvement in the Calgary Depression Scale, Simpson-Angus Scale, and Visual Analogue Scale (EVA) will also be observed. This scales were been used during the baseline, 3 months after, and then, 6 months.
RESULTS


Subjects, after 6-month treatment with amisulpride and quetiapine, did show statistically significant differences in the assessed areas: WAIS Coding Subtest (P < 0.001), CTMT A and B (CTMT A P < 0.034; CTMT B P < 0.000), and Stroop Tests: Word (P < 0.001), Word-Color (P < 0.007), and Interference (P < 0.039). Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001).
CONCLUSIONS


The results of this report show a cognitive and clinical improvement in refractory patients after the administration of amisulpride and quetiapine.",2020,"Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001).
","['Patients With Refractory Schizophrenia', 'patients with resistant schizophrenia']","['quetiapine', 'amisulpride and quetiapine', 'amisulpride', 'Combined Amisulpride and Quetiapine']","['Word-Color', 'Simpson-Angus Scale', 'Calgary Depression Scale', 'WAIS Coding Subtest, and Comprehensive Trail Making Test (CTMT', 'Calgary Depression Scale, Simpson-Angus Scale, and Visual Analogue Scale (EVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0242686', 'cui_str': 'EVA'}]",26.0,0.0198402,"Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001).
","[{'ForeName': 'Juan de Dios', 'Initials': 'JD', 'LastName': 'Molina', 'Affiliation': 'Head of Mental Health Center of Villaverde, Service of Psychiatry, Hospital 12 de Octubre ResearchInstitute (i+12), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Quintero', 'Affiliation': 'Head of Psychiatry Service, Hospital Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'García-Laredo', 'Affiliation': 'National Distance Education University, UNED, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'López-Muñoz', 'Affiliation': 'Faculty of Health Sciences and Criminology Degree, University Francisco de Vitoria (UFV), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Correas-Lauffer', 'Affiliation': 'Head of Psychiatry Service, Hospital del Henares, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Barbudo', 'Affiliation': 'Psychiatry Service, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceverino', 'Affiliation': 'Psychiatry Service, Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mur', 'Affiliation': 'Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Garcia-Resa', 'Affiliation': 'Mental Health Center of Villena, Hospital General Universitario de Elda, Alicante, Spain.'}]",American journal of therapeutics,['10.1097/MJT.0000000000000956']
845,31079057,Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study.,"BACKGROUND


To evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.
METHODS


In this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.
RESULTS


Of the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.
CONCLUSIONS


The low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.",2020,The low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.,"['patients with uni/bilateral neovascular age-related macular degeneration (nAMD', 'uni/bilateral neovascular age-related macular degeneration', '936 patients treated with', 'patients (N=941) aged ≥ 50 years']",['ranibizumab'],"['safety and tolerability', 'annual incidence rate (AIR', 'mean (SD) number of ranibizumab injections', 'good safety and tolerability', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853222', 'cui_str': 'Uni'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4060225', 'cui_str': 'ranibizumab Injection [Lucentis]'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",941.0,0.162823,The low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'Department of Ophthalmology, University Vita Salute Hospital San Raffaele, Milano, Italy bandello.francesco@hsr.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'UOSD Patologie Retiniche, Policlinico Tor Vergata, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Midena', 'Affiliation': 'Department of Ophthalmology, University of Padua, Padova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Viola', 'Affiliation': 'Department of Clinical Sciences and CommunityHealth, University of Milan, Ophthalmological Unit, IRCCS-Cà GrandaFoundation-Ospedale Maggiore Policlinico, Milano, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Lupieri Sinibaldi', 'Affiliation': 'Novartis Farma S.p.A, Largo Umberto Boccioni, Origgio, Origgio, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Colombo', 'Affiliation': 'Novartis Farma S.p.A, Largo Umberto Boccioni, Origgio, Origgio, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peruzzi', 'Affiliation': 'Novartis Farma S.p.A, Largo Umberto Boccioni, Origgio, Origgio, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Bassanini', 'Affiliation': 'Novartis Farma S.p.A, Largo Umberto Boccioni, Origgio, Origgio, Italy.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-313907']
846,31746775,Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial.,"BACKGROUND


Continuing medical education is important but time-consuming for general practitioners (GPs). Current learning approaches are limited and lack the ability to engage some practitioners. Serious games are new learning approaches that use video games as engaging teaching material. They have significant advantages in terms of efficiency and dissemination.
OBJECTIVE


The aim of this study was to create a serious game and to evaluate it in terms of effectiveness and satisfaction, comparing it with a traditional method of continuing education-article reading.
METHODS


We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent evidence-based medicine journals (reviews from Prescrire and Minerva). We created 51 clinical cases. We then conducted a double-blinded randomized trial comparing the learning provided by a week of access to the game versus source articles. Participants were GPs involved as resident supervisors in 14 French university departments of family practice, recruited by email. Primary outcomes were (1) mean final knowledge score completed 3 to 5 weeks after the end of the intervention and (2) mean difference between knowledge pretest (before intervention) and posttest (3 to 5 weeks after intervention) scores, both scaled on 10 points. Secondary outcomes were transfer of knowledge learned to practice, satisfaction, and time spent playing.
RESULTS


A total of 269 GPs agreed to participate in the study. Characteristics of participants were similar between learning groups. There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21). There was a mean difference score between knowledge pre- and posttests, with significantly superior performance for Hygie (mean gain of 1.6 in the Hygie group and 0.9 in the reading group; P=.02), demonstrating a more efficient and persistent learning with Hygie. The rate of participants that reported to have used the knowledge they learned through the teaching material was significantly superior in the Hygie group: 77% (47/61) in the Hygie group and 53% (25/47) in the reading group; odds ratio 2.9, 95% CI 1.2-7.4. Moreover, 87% of the opinions were favorable, indicating that Hygie is of interest for updating medical knowledge. Qualitative data showed that learners enjoyed Hygie especially for its playful, interactive, and stimulating aspects.
CONCLUSIONS


We conclude that Hygie can diversify the offering for continuing education for GPs in an effective, pleasant, and evidence-based way.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03486275; https://clinicaltrials.gov/ct2/show/NCT03486275.",2019,"There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21).","['Participants were GPs involved as resident supervisors in 14 French university departments of family practice, recruited by email', 'General Practitioners (Hygie']",[],"['transfer of knowledge learned to practice, satisfaction, and time spent playing', 'mean score of the final knowledge test', 'effectiveness and satisfaction', 'mean final knowledge score']","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",269.0,0.291733,"There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21).","[{'ForeName': 'Louis-Baptiste', 'Initials': 'LB', 'LastName': 'Jaunay', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Descartes, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Zerr', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Peguin', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Léandre', 'Initials': 'L', 'LastName': 'Renouard', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Ivanoff', 'Affiliation': 'Département de Médecine Générale, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Service de Recherche Clinique, Fondation Rothschild, Paris, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Griffith', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chassany', 'Affiliation': 'Patient-Reported Outcomes Research, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Duracinsky', 'Affiliation': 'Patient-Reported Outcomes Research, Sorbonne Paris Cité, Université Paris-Diderot, Paris, France.'}]",Journal of medical Internet research,['10.2196/12669']
847,31740348,"Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial.","BACKGROUND


Doravirine is a novel, non-nucleoside reverse transcriptase inhibitor that has shown non-inferior efficacy to ritonavir-boosted darunavir, with a superior lipid profile, in adults with HIV who were treatment naive at week 48 in the phase 3 DRIVE-FORWARD trial. Here we present the 96-week data for the study.
METHODS


This randomised, controlled, double-blind, multicentre, non-inferiority, phase 3 study was undertaken at 125 clinical centres in 15 countries. Eligible participants were adults (aged ≥18 years) infected with HIV-1 who were naive to antiretroviral therapy, with a plasma HIV-1 RNA concentration of 1000 copies per mL or higher at screening, and no known resistance to any of the study drugs. Participants were randomly assigned (1:1) using an interactive voice and web response system, stratified by baseline HIV-1 RNA concentration and background nucleoside reverse transcriptase inhibitor therapy, to doravirine (100 mg per day) or ritonavir-boosted darunavir (100 mg ritonavir and 800 mg darunavir per day), both with investigator-selected nucleoside reverse transcriptase inhibitors: emtricitabine and tenofovir disoproxil fumarate or abacavir and lamivudine. Participants and investigators were masked to treatment assignment until week 96. The primary efficacy endpoint was the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at week 48, which has been reported previously. Here we report the key secondary efficacy endpoint of the proportion of participants who achieved this concentration by week 96, assessed in all participants who received at least one dose of any study drug, regardless of whether it was their randomly assigned treatment. We used a US Food and Drug Administration snapshot approach and a margin of 10 percentage points to define the non-inferiority of doravirine to ritonavir-boosted darunavir at 96 weeks. Key safety endpoints were change in fasting serum lipid concentrations, the incidence of adverse events, and time to discontinuation due to an adverse event, assessed in all participants who received at least one dose of any study medication. This study is registered with ClinicalTrials.gov, NCT02275780, and is closed to accrual.
FINDINGS


Between Dec 1, 2014, and Oct 20, 2015, 1027 individuals were screened, of whom 769 participants were randomly assigned to doravirine (n=385) or ritonavir-boosted darunavir (n=384), and 383 in both groups were given at least one dose of their allocated treatment. Most participants were male (645 [84%] of 766) and white (560 [73%]), with a mean age of 35·2 years (SD 10·6). 292 participants in the doravirine group and 273 in the darunavir group completed 96 weeks of treatment. At week 96, a higher proportion of the doravirine group (277 [73%] of 383) achieved an HIV-1 RNA concentration of less than 50 copies per mL than did of the darunavir group (248 [66%] of 383; difference 7·1%, 95% CI 0·5-13·7). Responses were similar regardless of baseline characteristics. Treatment-emergent resistance to any study drug occurred in two (1%) of 383 participants in the doravirine group and one (<1%) of 383 in the ritonavir-boosted darunavir group. Significant differences were seen between treatment groups in mean changes from baseline in LDL cholesterol (-14·6 mg/dL, 95% CI -18·2 to -11·0) and non-HDL cholesterol (-18·4 mg/dL, -22·5 to -14·3). Frequencies of adverse events were similar between groups. No significant treatment difference (log-rank nominal p=0·063) through week 96 was observed in time to discontinuation due to an adverse event. The most common adverse events (week 0-96) were diarrhoea (65 [17%] in the doravirine group vs 91 [24%] in the ritonavir-boosted darunavir group), nausea (45 [12%] vs 52 [14%]), headache (57 [15%] vs 46 [12%]), and upper respiratory tract infection (51 [13%] vs 30 [8%]). Two participants, one in each group, died during treatment; neither death was considered to be related to study medication.
INTERPRETATION


These results through 96 weeks support the efficacy and safety results reported previously for doravirine at 48 weeks, supporting the use of doravirine for the long-term treatment of adults with previously untreated HIV-1 infection.
FUNDING


Merck.",2020,No significant treatment difference (log-rank nominal p=0·063) through week 96 was observed in time to discontinuation due to an adverse event.,"['participants who achieved this concentration by week 96, assessed in all participants who received at least one dose of any study drug, regardless of whether it was their randomly assigned treatment', 'Eligible participants were adults (aged ≥18 years) infected with HIV-1 who were naive to antiretroviral therapy, with a plasma HIV-1 RNA concentration of 1000 copies per mL or higher at screening, and no known resistance to any of the study drugs', 'antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD', 'adults with HIV who were treatment naive at week 48 in the phase 3 DRIVE-FORWARD trial', 'adults with previously untreated HIV-1 infection', '292 participants in the doravirine group and 273 in the darunavir group completed 96 weeks of treatment', 'Most participants were male (645 [84%] of 766) and white (560 [73%]), with a mean age of 35·2 years (SD 10·6', '383 participants in the doravirine group and one (<1%) of 383 in the ritonavir-boosted darunavir group', '125 clinical centres in 15 countries', '1027 individuals were screened, of whom 769 participants']","['doravirine to ritonavir-boosted darunavir', 'Doravirine versus ritonavir-boosted darunavir', 'interactive voice and web response system, stratified by baseline HIV-1 RNA concentration and background nucleoside reverse transcriptase inhibitor therapy, to doravirine (100 mg per day) or ritonavir-boosted darunavir (100 mg ritonavir and 800 mg darunavir per day), both with investigator-selected nucleoside reverse transcriptase inhibitors: emtricitabine and tenofovir disoproxil fumarate or abacavir and lamivudine', 'ritonavir-boosted darunavir', 'doravirine']","['death', 'diarrhoea', 'LDL cholesterol (-14·6', 'efficacy and safety', 'proportion of participants who had a plasma HIV-1 RNA concentration', 'headache', 'HIV-1 RNA concentration', 'upper respiratory tract infection', 'Frequencies of adverse events', 'non-HDL cholesterol (-18·4', 'fasting serum lipid concentrations, the incidence of adverse events, and time to discontinuation due to an adverse event', 'nausea']","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",769.0,0.490332,No significant treatment difference (log-rank nominal p=0·063) through week 96 was observed in time to discontinuation due to an adverse event.,"[{'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'University of Paris 7, Hôpital Saint Louis APHP, Paris, France.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Squires', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lombaard', 'Affiliation': 'Josha Research, Bloemfontein, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Ming-Tain', 'Initials': 'MT', 'LastName': 'Lai', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lupinacci', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sklar', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA.'}, {'ForeName': 'Elizabeth Anne', 'Initials': 'EA', 'LastName': 'Martin', 'Affiliation': 'Merck Sharpe & Dohme, Rahway, NJ, USA. Electronic address: elizabeth.martin1@merck.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30336-4']
848,29511047,Streptococcus pyogenes  Infection and the Human Proteome with a Special Focus on the Immunoglobulin G-cleaving Enzyme IdeS.,"Infectious diseases are characterized by a complex interplay between host and pathogen, but how these interactions impact the host proteome is unclear. Here we applied a combined mass spectrometry-based proteomics strategy to investigate how the human proteome is transiently modified by the pathogen  Streptococcus pyogenes , with a particular focus on bacterial cleavage of IgG  in vivo  In invasive diseases,  S. pyogenes  evokes a massive host response in blood, whereas superficial diseases are characterized by a local leakage of several blood plasma proteins at the site of infection including IgG.  S. pyogenes  produces IdeS, a protease cleaving IgG in the lower hinge region and we find highly effective IdeS-cleavage of IgG in samples from local IgG poor microenvironments. The results show that IdeS contributes to the adaptation of  S. pyogenes  to its normal ecological niches. Additionally, the work identifies novel clinical opportunities for  in vivo  pathogen detection.",2018,"Here we applied a combined mass spectrometry-based proteomics strategy to investigate how the human proteome is transiently modified by the pathogen  Streptococcus pyogenes , with a particular focus on bacterial cleavage of IgG  in vivo  In invasive diseases,  S. pyogenes  evokes a massive host response in blood, whereas superficial diseases are characterized by a local leakage of several blood plasma proteins at the site of infection including IgG.  S. pyogenes  produces IdeS, a protease cleaving IgG in the lower hinge region and we find highly effective IdeS-cleavage of IgG in samples from local IgG poor microenvironments.",[],[],[],[],[],[],,0.0168324,"Here we applied a combined mass spectrometry-based proteomics strategy to investigate how the human proteome is transiently modified by the pathogen  Streptococcus pyogenes , with a particular focus on bacterial cleavage of IgG  in vivo  In invasive diseases,  S. pyogenes  evokes a massive host response in blood, whereas superficial diseases are characterized by a local leakage of several blood plasma proteins at the site of infection including IgG.  S. pyogenes  produces IdeS, a protease cleaving IgG in the lower hinge region and we find highly effective IdeS-cleavage of IgG in samples from local IgG poor microenvironments.","[{'ForeName': 'Christofer A Q', 'Initials': 'CAQ', 'LastName': 'Karlsson', 'Affiliation': 'From the ‡Lund University, Division of Infection Medicine, Department of Clinical Sciences, Solvegatan 19, BMC, Lund, 221 84 Lund, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Järnum', 'Affiliation': '§Hansa Medical AB, Scheelevägen 22, 223 63 Lund, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Winstedt', 'Affiliation': '§Hansa Medical AB, Scheelevägen 22, 223 63 Lund, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kjellman', 'Affiliation': '§Hansa Medical AB, Scheelevägen 22, 223 63 Lund, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Björck', 'Affiliation': 'From the ‡Lund University, Division of Infection Medicine, Department of Clinical Sciences, Solvegatan 19, BMC, Lund, 221 84 Lund, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Linder', 'Affiliation': 'From the ‡Lund University, Division of Infection Medicine, Department of Clinical Sciences, Solvegatan 19, BMC, Lund, 221 84 Lund, Sweden.'}, {'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Malmström', 'Affiliation': 'From the ‡Lund University, Division of Infection Medicine, Department of Clinical Sciences, Solvegatan 19, BMC, Lund, 221 84 Lund, Sweden; johan.malmstrom@med.lu.se.'}]",Molecular & cellular proteomics : MCP,['10.1074/mcp.RA117.000525']
849,31721407,Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study.,"OBJECTIVES


To evaluate prospectively whether a tubeless (JJ stent-only) percutaneous nephrolithotomy (PCNL) might reduce the risk of hydrothorax, compared to an approach where a nephrostomy tube is left.
MATERIALS AND METHODS


We conducted a two-arm open-label prospective randomized study (NCT02036398) comparing tubeless supra-costal PCNL (with a JJ stent only) to standard PCNL (with nephrostomy tube and JJ stent) using intention-to-treat (ITT) and per-protocol (PP) analyses. All patients underwent a standard single-stage prone supra-costal procedure with single-tract access. Complication data were collected according to the Clavien-Dindo grading system. The primary endpoint was the rate of hydrothorax, and secondary endpoints included stone-free rate (SFR) and complication rate. Multivariable logistic regression analysis identified factors associated with hydrothorax formation.
RESULTS


Out of 101 patients approached, 75 were finally analysed. No differences were observed between the two arms with regard to baseline demographic and stone characteristics. The mean largest stone size ranged between 23 and 24.2 mm. No significant difference was seen in the mean operating time and length of hospital stay. The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs 15.8%, P = 0.031, and 38.4% vs 13.8%, P = 0.016, in the ITT and PP analyses, respectively). The SFR and complication rate were similar in both groups using the ITT and PP analyses. Multivariable logistic regression analysis showed that nephrostomy tube placement was the only covariate associated in a statistically significant manner to hydrothorax (odds ratio 3.628, 95% confidence interval 1.073-12.265; P = 0.038).
CONCLUSION


The rate of hydrothorax in supra-costal PCNL is associated with the type of postoperative drainage left. When possible, a tubeless approach should be applied as it may confer a lower risk of hydrothorax.",2020,"The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs. 15.8%, p=0.031, and 38.4% vs. 13.8%, p=0.016, in the ITT and PP analyses, respectively).","['101 patients approached, a total of 75 patients were finally analyzed']","['tubeless (double-J stent only) percutaneous nephrolithotomy (PN', 'tubeless supra-costal PN (with double-J stent only) to standard PN (with nephrostomy tube and double-J stent) using intention-to-treat (ITT) and per protocol (PP) analysis', 'Tubeless Supracostal Percutaneous Nephrolithotomy', 'standard single-stage prone supra-costal procedure with single tract access']","['incidence of hydrothorax', 'stone-free-rate and complication rate', 'mean largest stone size', 'rate of hydrothorax', 'mean operative time and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube (physical object)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020312', 'cui_str': 'Hydrothorax'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",101.0,0.0896166,"The incidence of hydrothorax was significantly higher in the nephrostomy group in comparison to the tubeless group (37.8% vs. 15.8%, p=0.031, and 38.4% vs. 13.8%, p=0.016, in the ITT and PP analyses, respectively).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Goldberg', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Amihay', 'Initials': 'A', 'LastName': 'Nevo', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Yariv', 'Initials': 'Y', 'LastName': 'Shtabholtz', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lubin', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Ehrlich', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lifshitz', 'Affiliation': 'Minimally Invasive Unit, Department of Urology, Golda Hospital, Rabin Medical Centre, Petach Tikva, Israel.'}]",BJU international,['10.1111/bju.14950']
850,31735057,Improvement in cognitive function in young people with bipolar disorder: Results from participants in an 18-month randomised controlled trial of adjunctive psychotherapy.,"OBJECTIVE


To examine the effects of 18 months of intensive stabilisation with medication management and Interpersonal and Social Rhythm Therapy or Non-specific Supportive Clinical Management on cognitive function in young people with bipolar disorder. Determinants of change in cognitive function over the 18 months of the trial were also examined.
METHOD


Patients aged 15-36 years with Bipolar I Disorder, Bipolar II Disorder and Bipolar Not Otherwise Specified were recruited. From a battery of cognitive tests, change scores for pre-defined domains of cognitive function were created based on performance at baseline and follow-up. Change was compared between the two therapy groups. Regression analysis was used to determine the impact of a range of clinical variables on change in cognitive performance between baseline and follow-up.
RESULTS


One hundred participants were randomised to Interpersonal and Social Rhythm Therapy ( n  = 49) or Non-specific Supportive Clinical Management ( n  = 51). Seventy-eight patients underwent cognitive testing at baseline and 18 months. Across both groups, there were significant improvements in a Global Cognitive Composite score, Executive Function and Psychomotor Speed domains from baseline to 18 months. Lower scores at baseline on all domains were associated with greater improvement over 18 months. Overall, there was no difference between therapies in change in cognitive function, either in a global composite score or change in domains.
CONCLUSION


While there was no difference between therapy groups, intensive stabilisation with psychological therapy was associated with improved cognitive function, particularly in those patients with poorer cognitive function at baseline. However, this was not compared with treatment as usual so cannot be attributed necessarily to the therapies.",2020,"Across both groups, there were significant improvements in a Global Cognitive Composite score, Executive Function and Psychomotor Speed domains from baseline to 18 months.","['Patients aged 15-36\u2009years with Bipolar I Disorder, Bipolar II Disorder and Bipolar', 'young people with bipolar disorder', 'One hundred participants']","['intensive stabilisation with medication management and Interpersonal and Social Rhythm Therapy or Non-specific Supportive Clinical Management', 'Interpersonal and Social Rhythm Therapy ( n \u2009=\u200949) or Non-specific Supportive Clinical Management', 'adjunctive psychotherapy']","['cognitive performance', 'cognitive function', 'Global Cognitive Composite score, Executive Function and Psychomotor Speed domains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0236788', 'cui_str': 'Bipolar II disorder (disorder)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",100.0,0.120988,"Across both groups, there were significant improvements in a Global Cognitive Composite score, Executive Function and Psychomotor Speed domains from baseline to 18 months.","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Porter', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Inder', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Moor', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Carter', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Christopher Ma', 'Initials': 'CM', 'LastName': 'Frampton', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Crowe', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, Christchurch, New Zealand.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867419887794']
851,31060545,Hypertension control in integrated HIV and chronic disease clinics in Uganda in the SEARCH study.,"BACKGROUND


There is an increasing burden of hypertension (HTN) across sub-Saharan Africa where HIV prevalence is the highest in the world, but current care models are inadequate to address the dual epidemics. HIV treatment infrastructure could be leveraged for the care of other chronic diseases, including HTN. However, little data exist on the effectiveness of integrated HIV and chronic disease care delivery systems on blood pressure control over time.
METHODS


Population screening for HIV and HTN, among other diseases, was conducted in ten communities in rural Uganda as part of the SEARCH study (NCT01864603). Individuals with either HIV, HTN, or both were referred to an integrated chronic disease clinic. Based on Uganda treatment guidelines, follow-up visits were scheduled every 4 weeks when blood pressure was uncontrolled, and either every 3 months, or in the case of drug stock-outs more frequently, when blood pressure was controlled. We describe demographic and clinical variables among all patients and used multilevel mixed-effects logistic regression to evaluate predictors of HTN control.
RESULTS


Following population screening (2013-2014) of 34,704 adults age ≥ 18 years, 4554 individuals with HTN alone or both HIV and HTN were referred to an integrated chronic disease clinic. Within 1 year 2038 participants with HTN linked to care and contributed 15,653 follow-up visits over 3 years. HTN was controlled at 15% of baseline visits and at 46% (95% CI: 44-48%) of post-baseline follow-up visits. Scheduled visit interval more frequent than clinical indication among patients with controlled HTN was associated with lower HTN control at the subsequent visit (aOR = 0.89; 95% CI 0.79-0.99). Hypertension control at follow-up visits was higher among HIV-infected patients than uninfected patients to have controlled blood pressure at follow-up visits (48% vs 46%; aOR 1.28; 95% CI 0.95-1.71).
CONCLUSIONS


Improved HTN control was achieved in an integrated HIV and chronic care model. Similar to HIV care, visit frequency determined by drug supply chain rather than clinical indication is associated with worse HTN control.
TRIAL REGISTRATION


The SEARCH Trial was prospectively registered with ClinicalTrials.gov : NCT01864603.",2019,HTN was controlled at 15% of baseline visits and at 46% (95% CI: 44-48%) of post-baseline follow-up visits.,"['Following population screening (2013-2014) of 34,704 adults age\u2009≥\u200918\u2009years, 4554 individuals with HTN alone or both HIV and HTN were referred to an integrated chronic disease clinic', 'Population screening for HIV and HTN, among other diseases, was conducted in ten communities in rural Uganda as part of the SEARCH study (NCT01864603', '2038 participants with HTN linked to care and contributed 15,653 follow-up visits over 3\u2009years', 'Individuals with either HIV, HTN, or both were referred to an integrated chronic disease clinic']",[],"['controlled blood pressure', 'Hypertension control', 'blood pressure control']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",2038.0,0.050454,HTN was controlled at 15% of baseline visits and at 46% (95% CI: 44-48%) of post-baseline follow-up visits.,"[{'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Asiphas', 'Initials': 'A', 'LastName': 'Owaraganise', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dathan', 'Initials': 'D', 'LastName': 'Byonanebye', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mwangwa', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Charlebois', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Petersen', 'Affiliation': 'University of California, Berkeley, CA, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lillian B', 'Initials': 'LB', 'LastName': 'Brown', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Lillian.Brown@ucsf.edu.'}]",BMC public health,['10.1186/s12889-019-6838-6']
852,31759193,In pursuit of a sensitive EEG functional connectivity outcome measure for clinical trials in Alzheimer's disease.,"OBJECTIVE


In clinical trials in Alzheimer's Disease (AD), an improvement of impaired functional connectivity (FC) could provide biological support for the potential efficacy of the drug. Electroencephalography (EEG) analysis of the SAPHIR-trial showed a treatment induced improvement of global relative theta power but not of FC measured by the phase lag index (PLI). We compared the PLI with the amplitude envelope correlation with leakage correction (AEC-c), a presumably more sensitive FC measure.
METHODS


Patients with early AD underwent 12 weeks of placebo or treatment with PQ912, a glutaminylcyclase inhibitor. Eyes-closed task free EEG was measured at baseline and follow-up (PQ912 n = 47, placebo n = 56). AEC-c and PLI were measured in multiple frequency bands. Change in FC was compared between treatment groups by using two models of covariates.
RESULTS


A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004, Cohen's d = 0.58). The effect remained significant when corrected for sex, country, ApoE ε4 carriage, age, baseline value (model 1; p = 0.006) and change in relative alpha power (model 2; p = 0.004).
CONCLUSIONS


Functional connectivity in early AD, measured with AEC-c in the alpha frequency band, improved after PQ912 treatment.
SIGNIFICANCE


AEC-c may be a robust and sensitive FC measure for detecting treatment effects.",2020,"A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004,","[""Alzheimer's Disease (AD"", ""Alzheimer's disease"", 'Patients with early AD underwent 12\u202fweeks of']","['placebo or treatment with PQ912, a glutaminylcyclase inhibitor', 'placebo']","['global AEC-c', 'Eyes-closed task free EEG', 'AEC-c and PLI', 'Change in FC']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0711372,"A significant increase in global AEC-c in the alpha frequency band was found with PQ912 treatment compared to placebo (p = 0.004,","[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Briels', 'Affiliation': 'Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands; Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands. Electronic address: c.briels@vumc.nl.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Stam', 'Affiliation': 'Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Scheltens', 'Affiliation': 'Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bruins', 'Affiliation': 'Probiodrug AG, Halle, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lues', 'Affiliation': 'Probiodrug AG, Halle, Germany.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gouw', 'Affiliation': 'Department of Clinical Neurophysiology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2019.09.014']
853,31732149,A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol.,"PURPOSE


The exhalation delivery system with fluticasone propionate (Xhance®) has been shown to deliver drug substantially more broadly in the nasal cavity (particularly into superior/posterior regions), with less off-target loss of drug to drip-out and swallowing, than conventional nasal sprays. This open-label study evaluated the systemic bioavailability of Xhance® by comparing the pharmacokinetic (PK) properties of a single dose of fluticasone from 3 products administering the drug using 3 different devices: Xhance®, Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol).
METHODS


This open-label study was conducted in 2 parts. Study part 1 compared systemic exposure with a single dose of Xhance® 186 or 372 μg versus Flonase® 400 μg (3-way, 3-treatment, 3-sequence, randomized crossover in healthy subjects; n = 90). A separate study, part 2, under the same umbrella protocol, compared systemic exposure with Xhance® 372 μg versus Flovent® HFA 440 μg (2-way, 2-treatment, 2-sequence, randomized crossover in patients with mild to moderate asthma; n = 30).
FINDINGS


With Xhance® 186 μg, the geometric least squares mean (LSM) C max  was higher than with Flonase® 400 μg (16.02 vs 11.66 pg/mL, respectively; geometric mean ratio [GMR], 137.42%) and the geometric LSM AUC 0-∞  values were similar (97.30 vs 99.61 pg · h/mL; GMR, 97.78%). With Xhance® 372 μg, the geometric LSM C max  and AUC 0-∞  were higher than with Flonase® 400 μg (C max , 23.50 vs 11.66 pg/mL [GMR, 201.53%]; AUC 0-∞ , 146.61 vs 99.61 pg · h/mL [GMR, 147.19%]). In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL [GMR, 63.18%]; AUC 0-∞ , 205.78 vs 415.16 pg · h/mL [GMR, 49.57%]).
IMPLICATIONS


Similar intranasal doses of Xhance® (372 μg) and Flonase® (400 μg) are clearly not bioequivalent. Systemic exposure is very low with all products. Systemic exposure is higher with Xhance® than with Flonase® and substantially lower than with Flovent® HFA 440 μg and, based on dose normalization, Flovent® HFA 220 μg. ClincalTrials.gov identifier: NCT02266927.",2019,"In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL","['healthy subjects; n\xa0=\xa090', 'ClincalTrials.gov identifier', 'patients with mild to moderate asthma; n\xa0=\xa030']","['Fluticasone Propionate', 'Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol', 'Xhance® 186 or 372\xa0μg versus Flonase® 400\xa0μg', 'fluticasone propionate (Xhance®', 'Xhance® 372\xa0μg versus Flovent®', 'fluticasone', 'Xhance®']","['geometric LSM AUC 0-∞  values', 'geometric least squares mean (LSM) C max', 'geometric LSM C max  and AUC 0-∞  values', 'geometric LSM C max  and AUC 0-∞']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0286677', 'cui_str': 'Flonase'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0720466', 'cui_str': 'Flovent'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C4529471', 'cui_str': 'Xhance'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.231023,"In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Messina', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States. Electronic address: john.messina@optinose.com.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Offman', 'Affiliation': 'Certara, Montreal, Quebec, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Carothers', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States.'}, {'ForeName': 'Ramy A', 'Initials': 'RA', 'LastName': 'Mahmoud', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.013']
854,31731879,SURE Test Accuracy for Decisional Conflict Screening among Parents Making Decisions for Their Child.,"Background . We aimed to validate the SURE test for use with parents in primary care.  Methods . A secondary analysis of cluster randomized trial data was used to compare the SURE test (index, higher score = less conflict) to the Decisional Conflict Scale (DCS; reference, higher score = greater conflict). Our a priori hypothesis was that the scales would correlate negatively. We evaluated the association between scores and estimated the proportion of variance in the DCS explained by the SURE test. Then, we dichotomized each measure using established cutoffs to calculate diagnostic accuracy and internal consistency with confidence intervals adjusted for clustering. We evaluated the presence of effect modification by sex, followed by sex-specific calculation of validation statistics.  Results . In total, 185 of 201 parents completed a DCS and SURE test. Total DCS (mean = 4.2/100, SD = 14.3) and SURE test (median 4/4; interquartile range, 4-4) scores were significantly correlated (ρ = -0.36,  P  < 0.0001). The SURE test explained 34% of the DCS score variance. Internal consistency (Kuder-Richardson 20) was 0.38 ( P  < 0.0001). SURE test sensitivity and specificity for identifying decisional conflict were 32% (95% confidence interval [CI], 20%-44%) and 96% (95% CI, 93%-100%), respectively. The SURE test's positive likelihood ratio was 8.4 (95% CI, 0.1-17) and its negative likelihood ratio was 0.7 (95% CI, 0.53-0.87). There were no significant differences between females and males in DCS ( P  = 0.5) or SURE test ( P  = 0.97) total scores; however, correlations between test total scores (-0.37 for females v. for -0.21 for males;  P  = 0.001 for the interaction) and sensitivity and specificity were higher for females than males.  Conclusions . SURE test demonstrated acceptable psychometric properties for screening decisional conflict among parents making a health decision about their child in primary care. However, clinicians cannot be confident that a negative SURE test rules out the presence of decisional conflict.",2019,SURE test demonstrated acceptable psychometric properties for screening decisional conflict among parents making a health decision about their child in primary care.,[],[],"[""SURE test's positive likelihood ratio"", 'Decisional Conflict Scale (DCS; reference, higher score = greater conflict', 'negative likelihood ratio', 'sensitivity and specificity', 'Total DCS']",[],[],"[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",201.0,0.122422,SURE test demonstrated acceptable psychometric properties for screening decisional conflict among parents making a health decision about their child in primary care.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Boland', 'Affiliation': 'School of Health Studies, Western University, London ON, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'CHU de Québec Research Centre-Université Laval site Hôpital, Quebec City, QC, Canada.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'McIsaac', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Graham', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dècary', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Laval University, Quebec, QC, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19884541']
855,31021419,Does maternal attachment to her infant mediate the link between perceptions of infant crying at 6 months and parenting stress at 24 months? A structural equation modelling approach.,"BACKGROUND


Parenting stress is influenced by many factors including maternal attachment and excessive infant crying, yet the nature of these relationships is not well understood. For example, excessive infant crying despite maternal soothing may impact maternal attachment to the child, leading to higher stress. This paper explored whether maternal perception of excessive infant crying at 6 months was associated with higher maternal parenting stress at 24 months, and whether maternal attachment mediated this relationship.
METHODS


All families, present at 24 months in a randomized controlled trial of a 5-year early intervention programme targeting school readiness skills in disadvantaged area of Ireland, were included. At 6 months, infant crying was assessed using a maternal reported measure of duration of infant crying, and maternal attachment to the infant was assessed using the Condon Maternal Attachment Scale. Parenting stress was assessed at 24 months using the childrearing stress subscale from the Parenting Stress Index. Structural equation modelling was used to explore the direct and indirect effects of maternal perceptions of excessive infant crying on parenting stress, controlling for infant, maternal, and environmental characteristics, and focusing on the mediating role of maternal attachment.
RESULTS


Reporting excessive infant crying at 6 months was associated with lower maternal attachment at 6 months, which led to higher parenting stress at 24 months. In addition, vulnerable adult attachment style, previous maternal mental health difficulties, low paternal education, paternal involvement with the child, and not being married were associated with higher parenting stress.
CONCLUSION


Findings suggest that the association between maternal perceptions of excessive crying at 6 months and later parenting stress may be mediated through maternal attachment to the infant. Interventions based on improving maternal attachment could be investigated to determine the effectiveness of supporting mothers with low attachment.",2019,"Structural equation modelling was used to explore the direct and indirect effects of maternal perceptions of excessive infant crying on parenting stress, controlling for infant, maternal, and environmental characteristics, and focusing on the mediating role of maternal attachment.
","['in disadvantaged area of Ireland, were included']",['5-year early intervention programme targeting school readiness skills'],"['parenting stress', 'maternal perception of excessive infant crying', 'infant crying', 'duration of infant crying, and maternal attachment to the infant was assessed using the Condon Maternal Attachment Scale', 'maternal parenting stress', 'Parenting stress']","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0222045'}]",,0.0402931,"Structural equation modelling was used to explore the direct and indirect effects of maternal perceptions of excessive infant crying on parenting stress, controlling for infant, maternal, and environmental characteristics, and focusing on the mediating role of maternal attachment.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Bailhache', 'Affiliation': 'Pole de pediatrie, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Doyle', 'Affiliation': 'UCD Geary Institute for Public Policy, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Louis-Rachid', 'Initials': 'LR', 'LastName': 'Salmi', 'Affiliation': 'ISPED, Centre INSERM U1219 Bordeaux Population Health, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'McDonnell', 'Affiliation': 'UCD School of Economics, University College Dublin, Dublin, Ireland.'}]","Child: care, health and development",['10.1111/cch.12676']
856,31053885,Comparison of morphological changes of gluteus medius and abductor strength for total hip arthroplasty via posterior and modified direct lateral approaches.,"BACKGROUND


It is a general belief among orthopedists that the muscle damage of the hip abductors after total hip arthroplasty (THA) is theoretically minimal via posterior approach. However, there is little data scientifically supporting the purported advantage. The purpose of this study was to quantifiably assess the injury to the gluteus medius (GMED) after THA via the minimally invasive (MIS) posterior and the modified direct lateral (mDL) approaches.
METHODS


Sixty-four consecutive patients enrolled prospectively were randomly assigned to the MIS posterior and the mDL approach groups. Three-dimensional MRI reconstruction of bilateral GMED, abductor strength measurement as well as post-operative pain assessment were included in the analysis. Data were collected pre-operatively, six, 12, and 52 weeks post-operatively.
RESULTS


Interestingly, in terms of the morphological changes of GMED, the MIS posterior approach showed a more significant degeneration caused by the surgical trauma compared with the mDL approach in both muscle volume atrophy and fatty infiltration from six to 52 weeks post-operatively. However, the improvement of abductor muscle strength on surgical side and VAS pain score were comparable between the two groups during the entire follow-up.
CONCLUSION


The injury of hip abductors after THA via posterior approach cannot be neglected. And, the planned detachment of partial GMED tendon combined with the reconstruction in situ could also achieve the satisfactory muscle recovery. Moreover, the post-operative rehabilitation of abductor strength was the aggregated results of a battery of factors, especially the pain, not just determined by the muscular morphological changes.",2019,"However, the improvement of abductor muscle strength on surgical side and VAS pain score were comparable between the two groups during the entire follow-up.
","['Sixty-four consecutive patients enrolled', 'total hip arthroplasty via posterior and modified direct lateral approaches']",['THA via the minimally invasive (MIS) posterior and the modified direct lateral (mDL) approaches'],['abductor muscle strength on surgical side and VAS pain score'],"[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}]","[{'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",64.0,0.0224901,"However, the improvement of abductor muscle strength on surgical side and VAS pain score were comparable between the two groups during the entire follow-up.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1, Yixueyuan Road, Yuanjiagang, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Shao', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1, Yixueyuan Road, Yuanjiagang, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1, Yixueyuan Road, Yuanjiagang, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1, Yixueyuan Road, Yuanjiagang, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1, Yixueyuan Road, Yuanjiagang, Yuzhong District, Chongqing, China. huangwei68@263.net.'}]",International orthopaedics,['10.1007/s00264-019-04331-z']
857,30954433,Human growth hormone for poor responders: a randomized placebo-controlled trial provides no evidence for improved live birth rate.,"RESEARCH QUESTION


Does the addition of human growth hormone (HGH) to an IVF cycle improve the live birth rate in previously documented poor responders to FSH?
DESIGN


Double-blind, placebo-controlled, randomized clinical trial comparing HGH to placebo in maximal stimulation in an IVF cycle. The study was stopped after 4 years. Women receiving ovarian stimulation in one IVF cycle, having failed to produce more than 5 eggs in a previous cycle with more than 250 IU/day of FSH were included. Basal FSH was ≤15 IU/l, body mass index <33 kg/m 2 , age <41 years. HGH or placebo were added from the start of the cycle in a double-blinded manner. The primary outcome was live birth rate.
MAIN RESULTS


The live birth rates following an IVF cycle were 9/62 (14.5%) for growth hormone and 7/51 (13.7%) for the placebo group (risk difference 0.8%, 95% confidence interval [CI] -12.1 to 13.7%; odds ratio [OR] 1.07, 95% CI 0.37-3.10). There was a greater odds of oocyte retrieval with growth hormone (OR 5.67, 95% CI 1.54-20.80) but no better chance of embryo transfer (OR 1.42, 95% CI 0.50-4.00). Birth weights were comparable.
CONCLUSIONS


Planned participant numbers were not reached. It was not possible to demonstrate an increase in live birth rate from the addition of growth hormone in women with a previous poor ovarian response to IVF.",2019,"The live birth rates following an IVF cycle were 9/62 (14.5%) for growth hormone and 7/51 (13.7%) for the placebo group (risk difference 0.8%, 95% confidence interval [CI] -12.1 to 13.7%; odds ratio [OR] 1.07, 95% CI 0.37-3.10).","['Women receiving ovarian stimulation in one IVF cycle, having failed to produce more than 5 eggs in a previous cycle with more than 250\xa0IU/day of FSH', '33', 'Human growth hormone for poor responders']","['HGH or placebo', 'Basal FSH', 'placebo', 'human growth hormone (HGH']","['live birth rates', 'Birth weights', 'live birth rate', 'oocyte retrieval with growth hormone (OR', 'chance of embryo transfer']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0404268', 'cui_str': 'Oocyte Collection'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",,0.756965,"The live birth rates following an IVF cycle were 9/62 (14.5%) for growth hormone and 7/51 (13.7%) for the placebo group (risk difference 0.8%, 95% confidence interval [CI] -12.1 to 13.7%; odds ratio [OR] 1.07, 95% CI 0.37-3.10).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia; , Fertility SA, 431 King William Road, Adelaide, SA 5000, Australia. Electronic address: robert.norman@adelaide.edu.au.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Alvino', 'Affiliation': 'University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Hull', 'Affiliation': 'University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia; South Australian Health and Medical Research Institute, Robinson Research Institute, North Adelaide, SA 5006; Monash University, Clayton, VIC 3800, Australia.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Hart', 'Affiliation': 'Fertility Specialists of Western Australia, Claremont, WA 6010; The University of Western Australia, Crawley, WA 6009, Australia.'}, {'ForeName': 'Thu-Lan', 'Initials': 'TL', 'LastName': 'Kelly', 'Affiliation': 'Adelaide Health Technology Assessment, School of Public Health, The University of Adelaide, Adelaide, SA 5006; Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Luk', 'Initials': 'L', 'LastName': 'Rombauts', 'Affiliation': 'Monash IVF, Monash Surgical Private Hospital, Clayton, VIC 3168, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.02.003']
858,31040253,Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial.,"LESSONS LEARNED


Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study. The efficacy could not be determined because of the small sample size.GCTB recurrences, even in the denosumab era, are still an issue; therefore, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid.
BACKGROUND


Bisphosphonates are assumed to inhibit giant cell tumor of bone (GCTB)-associated osteoclast activity and have an apoptotic effect on the neoplastic mononuclear cell population. The primary objective of this study was to determine the 2-year recurrence rate of high-risk GCTB after adjuvant zoledronic acid versus standard care.
METHODS


In this multicenter randomized open-label phase II trial, patients with high-risk GCTB were included (December 2008 to October 2013). Recruitment was stopped because of low accrual after the introduction of denosumab. In the intervention group, patients received adjuvant zoledronic acid (4 mg) intravenously at 1, 2, 3, 6, 9, and 12 months after surgery.
RESULTS


Fourteen patients were included (intervention  n  = 8, controls  n  = 6). Median follow-up was long: 93.5 months (range, 48-111). Overall 2-year recurrence rate was 38% (3/8) in the intervention versus 17% (1/6) in the control group ( p  = .58). All recurrences were seen within the first 15 months after surgery.
CONCLUSION


Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of GCTB in this study. The efficacy could not be determined because of the small sample size. Because recurrences, even in the denosumab era, are still an issue, a randomized study exploring the efficacy of zoledronic acid in the adjuvant setting in GCTB is still valid.",2019,Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study.,"['High-Risk Giant Cell Tumor of Bone', 'patients with high-risk GCTB were included (December 2008 to October 2013', 'Fourteen patients were included (intervention  n  = 8, controls  n  = 6']","['adjuvant zoledronic acid', 'Adjuvant Zoledronic Acid', 'zoledronic acid']","['2-year recurrence rate of high-risk GCTB', 'recurrence rate of GCTB', 'Overall 2-year recurrence rate', 'recurrence rate of giant cell tumor of bone (GCTB']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0206638', 'cui_str': 'Giant Cell Tumor of Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0206638', 'cui_str': 'Giant Cell Tumor of Bone'}]",14.0,0.0940716,Adjuvant treatment with zoledronic acid did not decrease the recurrence rate of giant cell tumor of bone (GCTB) in this study.,"[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lipplaa', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands a.lipplaa@lumc.nl.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Lizz', 'Initials': 'L', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Orthopedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Jutte', 'Affiliation': 'Department of Orthopedic Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pancras C W', 'Initials': 'PCW', 'LastName': 'Hogendoorn', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Orthopedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0280']
859,29864732,Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.,"BACKGROUND


Elevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women including rumination (i.e., repetitive negative thinking) and low social support. This article describes the rationale and design of a multicenter randomized controlled trial to test the effects of telephone-delivered MBCT (MBCT-T) in women with MI.
METHODS


We plan to randomize 144 women reporting elevated perceived stress at least two months after MI to MBCT-T or enhanced usual care (EUC), which each involve eight weekly telephone sessions. Perceived stress and a set of patient-centered health outcomes and potential mediators will be assessed before and after the 8-week telephone programs and at 6-month follow-up. We will test the hypothesis that MBCT-T will be associated with greater 6-month improvements in perceived stress (primary outcome), disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality (secondary outcomes) compared with EUC. Changes in mindfulness, rumination and perceived social support will be evaluated as potential mediators in exploratory analyses.
CONCLUSIONS


If found to be effective, this innovative, scalable intervention may be a promising secondary prevention strategy for women with MI experiencing elevated perceived stress.",2018,"Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches.","['women with MI experiencing elevated perceived stress', '144 women reporting elevated perceived stress at least two months after MI to', 'women with myocardial infarction', 'women with MI']","['Telephone-based mindfulness training', 'telephone-delivered MBCT (MBCT-T', 'Psychosocial interventions', 'MBCT-T or enhanced usual care (EUC', 'Mindfulness-based cognitive therapy (MBCT']","['disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",144.0,0.143601,"Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches.","[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Spruill', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY. Electronic address: Tanya.Spruill@nyumc.org.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Victoria Vaughan', 'Initials': 'VV', 'LastName': 'Dickson', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shallcross', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Pallavi D', 'Initials': 'PD', 'LastName': 'Visvanathan', 'Affiliation': 'Manhattan Center for Mindfulness-Based Cognitive Behavioral Therapy, New York, NY.'}, {'ForeName': 'Chorong', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Jolaade', 'Initials': 'J', 'LastName': 'Kalinowski', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Glenn I', 'Initials': 'GI', 'LastName': 'Fishman', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2018.03.028']
860,31574228,Effects of a Resuscitation Strategy Targeting Peripheral Perfusion Status versus Serum Lactate Levels among Patients with Septic Shock. A Bayesian Reanalysis of the ANDROMEDA-SHOCK Trial.,"Rationale:  A recent randomized controlled trial showed that a peripheral perfusion-guided resuscitation strategy was associated with lower mortality and less organ dysfunction when compared with lactate-guided resuscitation strategy in patients with septic shock, but the difference in the primary outcome, 28-day mortality, did not reach the proposed statistical significance threshold ( P  = 0.06). We tested different analytic methods to aid in the interpretation of these results. Objectives:  To reassess the results of the ANDROMEDA-SHOCK trial using both Bayesian and frequentist frameworks. Methods:  All patients recruited in ANDROMEDA-SHOCK were included. Both a  post hoc  Bayesian analysis and a mixed logistic regression analysis were performed. The Bayesian analysis included four different priors (optimistic, neutral, null, and pessimistic) for mortality endpoints. The probability of having a Sequential Organ Failure Assessment in the lowest quartile at 72 hours was assessed using Bayesian networks. Measurements and Main Results:  In the Bayesian analysis, the posterior probability that a peripheral perfusion-targeted resuscitation strategy is superior to lactate-targeted resuscitation at 28 days was above 90% for all priors; the probability of benefit at 90 days was above 90% for all but the pessimistic prior. Using an optimistic prior, posterior median odds ratios were 0.61 (95% credible interval, 0.41-0.90) and 0.68 (95% credible interval, 0.47-1.01) for 28-day and 90-day mortality, respectively. The comparable frequentist odds ratios for 28-day and 90-day mortality were 0.61 (95% confidence interval [CI], 0.38-0.92) and 0.70 (95% CI, 0.45-1.08), respectively. The odds that that patients in the peripheral perfusion-targeted resuscitation arm had Sequential Organ Failure Assessment scores in the lower quartile at 72 hours was 1.55 (95% CI, 1.02-2.37). Conclusions:  Peripheral perfusion-targeted resuscitation may result in lower mortality and faster resolution of organ dysfunction when compared with a lactate-targeted resuscitation strategy.",2020,"Using an optimistic prior, the Bayesian intervention odds ratio was 0.63 (95% credible interval 0.41-0.90) and 0.69 (95% credible interval 0.47-1.01) for 28-and 90-days mortality, respectively.","['patients with septic shock', 'Patients with Septic Shock', 'All patients recruited in the ANDROMEDA-Shock trial were included']","['peripheral perfusion-guided resuscitation strategy', 'Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels']","['frequentist odds ratios for 28-day and 90-day mortality', 'SOFA scores', 'probability of having a SOFA', 'lower mortality and faster resolution of organ dysfunction', 'lower mortality and less organ dysfunction', 'probability of benefit at 90-days', 'posterior probability that a peripheral perfusion-targeted resuscitation strategy is superior to lactate-targeted resuscitation at 28-days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0330433', 'cui_str': 'Andromeda (organism)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}]",,0.239825,"Using an optimistic prior, the Bayesian intervention odds ratio was 0.63 (95% credible interval 0.41-0.90) and 0.69 (95% credible interval 0.47-1.01) for 28-and 90-days mortality, respectively.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Ospina-Tascón', 'Affiliation': 'Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICESI, Cali, Colombia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0968OC']
861,31868987,"Effects of acupuncture on obstructive sleep apnea severity, blood pressure control and quality of life in patients with hypertension: A randomized controlled trial.","Obstructive sleep apnea (OSA) is a common condition among patients with hypertension and treatment with continuous positive airway pressure (CPAP) can decrease blood pressure (BP). However, CPAP is not well tolerated by a significant proportion of patients. The authors investigated the effects of acupuncture on OSA severity and BP control in patients with hypertension. Hypertensive patients with mild to moderate OSA (apnea-hypopnea index, 5-30 events/hr) were randomly assigned to receive acupuncture or sham-acupuncture treatment. Patients were assessed at baseline and after 10 acupuncture sessions using polysomnography, 24-hr ambulatory BP monitoring and a quality of life questionnaire. Forty-four patients (34% men; mean age, 57.0 ± 5.4 years; body mass index, 29.6 ± 3.2 kg/m 2  ; apnea-hypopnea index, 16.3 ± 6.7 events/hr) completed the study. There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05). Acupuncture therapy in hypertensive patients with OSA did not reduce OSA severity, daytime or nocturnal BP, or quality of life.",2020,"There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05).","['Forty-four patients (34% men; mean age, 57.0\xa0±\xa05.4\xa0years; body mass index, 29.6\xa0±\xa03.2\xa0kg/m 2  ; apnea-hypopnea index, 16.3\xa0±\xa06.7\xa0events/hr) completed the study', 'patients with hypertension', 'hypertensive patients with OSA', 'Hypertensive patients with mild to moderate OSA (apnea-hypopnea index, 5-30\xa0events/hr', 'patients with hypertension and treatment with continuous positive airway pressure (CPAP']","['acupuncture or sham-acupuncture treatment', 'Acupuncture therapy', 'CPAP', 'acupuncture']","['OSA severity, daytime or nocturnal BP, or quality of life', 'pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life', 'obstructive sleep apnea severity, blood pressure control and quality of life', 'blood pressure (BP', 'polysomnography, 24-hr ambulatory BP monitoring and a quality of life questionnaire', 'OSA severity and BP control', 'Obstructive sleep apnea (OSA']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",44.0,0.0248392,"There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05).","[{'ForeName': 'Marcus Vinícius F P', 'Initials': 'MVFP', 'LastName': 'Silva', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Thais C', 'Initials': 'TC', 'LastName': 'Lustosa', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Arai', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Tarcya L G', 'Initials': 'TLG', 'LastName': 'Couto Patriota', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Maria P F', 'Initials': 'MPF', 'LastName': 'Lira', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Ozeas L', 'Initials': 'OL', 'LastName': 'Lins-Filho', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Sintya T', 'Initials': 'ST', 'LastName': 'Chalegre', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'B B A S', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Isaac V', 'Initials': 'IV', 'LastName': 'Secundo', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Pedrosa', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}]",Journal of sleep research,['10.1111/jsr.12954']
862,31869005,Between-Individual Differences in Baseline Well-Being and Emotion Regulation Strategy Use Moderate the Effect of a Self-Help Cognitive-Behavioral Intervention for Typical Adults.,"BACKGROUND


Self-help interventions intended to help nonclinical individuals regulate their emotions can have important social benefits (i.e. mental disorder prevention, well-being promotion). However, their mean effect size on well-being is generally low, possibly because there are considerable between-individual differences in the response to these interventions. The present study examined whether individuals' baseline levels of emotional well-being and engagement in emotion regulation strategies moderate the effects on these same variables in a 4-week self-help cognitive-behavioral intervention intended for typical adults.
METHODS


Data were collected from 158 nonclinical French adults (n = 95 for the control group, n = 63 for the cognitive-behavioral group) using experience sampling. Emotional well-being was assessed, as well as the engagement in three emotion regulation strategies (i.e. cognitive reappraisal, problem solving, and appreciation).
RESULTS


As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables. In particular, it was the participants with the most negative baseline levels (i.e. low emotional well-being, low engagement in appreciation) who benefitted most from the intervention.
CONCLUSIONS


Results are discussed in the light of current knowledge on between-individual differences in how individuals respond to interventions.",2020,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","['Data were collected from 158 nonclinical French adults (n\xa0=\xa095 for the control group, n\xa0=\xa063 for the cognitive-behavioral group) using experience sampling', 'Typical Adults']",['Self-Help Cognitive-Behavioral Intervention'],[],"[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279973', 'cui_str': 'Experience Sampling'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.0158524,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Pavani', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Berna', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Guiller', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Pays de la Loire Psychology Laboratory (LPPL), University of Nantes, Nantes, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12189']
863,31050026,Parent-directed intervention in promoting knowledge of pediatric nutrition and healthy lifestyle among low-SES families with toddlers: A randomized controlled trial.,"OBJECTIVE


The objective of this study is to determine the efficacy of an interactive, home visiting curriculum tailored to low socio-economic status families in improving parental knowledge of paediatric nutrition and healthy lifestyle.
METHODS


Parents of toddlers aged 13-16 months living with a household income below 200% of the federal poverty line were randomized into healthy lifestyle intervention and control home visiting curriculum groups. Each curriculum consisted of 12 one-on-one educational sessions with parents facilitated by a trained home-visitor that were administered over a 6-month intervention period. Knowledge assessments were administered before and after the intervention period.
RESULTS


Results of a one-way analysis of covariance (ANCOVA) analysis showed that parents in the intervention group (M = 26.05, SD = 4.24) scored significantly higher than control parents (M = 23.84, SD = 4.26) post-intervention, controlling for parent education level, F(1, 102) = 7.494 (95% confidence interval [-3.68, -0.59]). One-way ANCOVA analysis showed no significant mean difference between the parents in the intervention group (M = 24.13, SD = 4.37) and the control group (M = 23.93, SD = 4.16) at baseline, controlling for parent education level, F(1, 163) = 0.002 (95% confidence interval [-1.28, 1.22]).
CONCLUSIONS


An interactive healthy lifestyle intervention focused on low-SES families significantly improved parental knowledge of paediatric healthy lifestyle. Changes in parental knowledge is a key preliminary step in behaviour change to ultimately affect behaviour. Informing and encouraging parents of toddlers to guide healthy lifestyle development early remains a promising point of intervention for prevention, rather than remediation, of childhood obesity.",2019,"One-way ANCOVA analysis showed no significant mean difference between the parents in the intervention group (M = 24.13, SD = 4.37) and the control group (M = 23.93, SD = 4.16) at baseline, controlling for parent education level, F(1, 163) = 0.002","['low-SES families with toddlers', 'Parents of toddlers aged 13-16\xa0months living with a household income below 200% of the federal poverty line']","['interactive healthy lifestyle intervention', 'healthy lifestyle intervention and control home visiting curriculum groups']",['parental knowledge of paediatric healthy lifestyle'],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]",,0.0566173,"One-way ANCOVA analysis showed no significant mean difference between the parents in the intervention group (M = 24.13, SD = 4.37) and the control group (M = 23.93, SD = 4.16) at baseline, controlling for parent education level, F(1, 163) = 0.002","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'LoRe', 'Affiliation': ""Department of Pediatrics, Morgan Stanley Children's Hospital of NewYork-Presbyterian, Columbia University Medical Center, New York, NY.""}, {'ForeName': 'Christy Y Y', 'Initials': 'CYY', 'LastName': 'Leung', 'Affiliation': 'TMW Center for Early Learning and Public Health, Department of Surgery, The University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Brenner', 'Affiliation': 'TMW Center for Early Learning and Public Health, Department of Surgery, The University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Suskind', 'Affiliation': 'TMW Center for Early Learning and Public Health, Department of Surgery, The University of Chicago Medicine, Chicago, Illinois.'}]","Child: care, health and development",['10.1111/cch.12682']
864,31204776,Effectiveness of sensor monitoring in a rehabilitation programme for older patients after hip fracture: a three-arm stepped wedge randomised trial.,"OBJECTIVES


to test the effects of an intervention involving sensor monitoring-informed occupational therapy on top of a cognitive behavioural treatment (CBT)-based coaching therapy on daily functioning in older patients after hip fracture.
DESIGN, SETTING AND PATIENTS


three-armed randomised stepped wedge trial in six skilled nursing facilities, with assessments at baseline (during admission) and after 1, 4 and 6 months (at home). Eligible participants were hip fracture patients ≥ 65 years old.
INTERVENTIONS


patients received care as usual, CBT-based occupational therapy or CBT-based occupational therapy with sensor monitoring. Interventions comprised a weekly session during institutionalisation, followed by four home visits and four telephone consultations over three months.
MAIN OUTCOMES AND MEASURES


the primary outcome was patient-reported daily functioning at 6 months, assessed with the Canadian Occupational Performance Measure.
RESULTS


a total of 240 patients (mean[SD] age, 83.8[6.9] years were enrolled. At baseline, the mean Canadian Occupational Performance Measure scores (range 1-10) were 2.92 (SE 0.20) and 3.09 (SE 0.21) for the care as usual and CBT-based occupational therapy with sensor monitoring groups, respectively. At six months, these values were 6.42 (SE 0.47) and 7.59 (SE 0.50). The mean patient-reported daily functioning in the CBT-based occupational therapy with sensor monitoring group was larger than that in the care as usual group (difference 1.17 [95% CI (0.47-1.87) P = 0.001]. We found no significant differences in daily functioning between CBT-based occupational therapy and care as usual.
CONCLUSIONS AND RELEVANCE


among older patients recovering from hip fracture, a rehabilitation programme of sensor monitoring-informed occupational therapy was more effective in improving patient-reported daily functioning at six months than to care as usual.
TRIAL REGISTRATION


Dutch National Trial Register, NTR 5716.",2019,"We found no significant differences in daily functioning between CBT-based occupational therapy and care as usual.
","['older patients after hip fracture', 'Eligible participants were hip fracture patients ≥ 65 years old', 'older patients recovering from hip fracture', 'three-armed randomised stepped wedge trial in six skilled nursing facilities, with assessments at baseline (during admission) and after 1, 4 and 6 months (at home', '240 patients ', 'mean[SD] age, 83.8[6.9] years were enrolled']","['intervention involving sensor monitoring-informed occupational therapy', 'care as usual, CBT-based occupational therapy or CBT-based occupational therapy with sensor monitoring', 'sensor monitoring', 'cognitive behavioural treatment (CBT)-based coaching therapy']","['mean patient-reported daily functioning', 'daily functioning', 'patient-reported daily functioning at 6 months, assessed with the Canadian Occupational Performance Measure', 'mean Canadian Occupational Performance Measure scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C0037265', 'cui_str': 'Extended Care Facilities'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0585045', 'cui_str': 'During admission (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}, {'cui': 'C2733180', 'cui_str': 'COPM (Canadian occupational performance measure) score'}]",6.0,0.0816301,"We found no significant differences in daily functioning between CBT-based occupational therapy and care as usual.
","[{'ForeName': 'Margriet C', 'Initials': 'MC', 'LastName': 'Pol', 'Affiliation': 'ACHIEVE, Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Ter Riet', 'Affiliation': 'Department General Practice, Amsterdam UMC, University of Amsterdam, The Netherlands.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'van Hartingsveldt', 'Affiliation': 'ACHIEVE, Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Kröse', 'Affiliation': 'Research Group Digital Life, Amsterdam University of Applied Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Buurman', 'Affiliation': 'ACHIEVE, Centre of Applied Research, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]",Age and ageing,['10.1093/ageing/afz074']
865,31733180,A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.,"BACKGROUND


Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.
METHODS


We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns.
RESULTS


After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
CONCLUSIONS


In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).",2020,"A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
",['1644 patients without an established indication for oral anticoagulation after successful TAVR to receive'],"['direct factor Xa inhibitor rivaroxaban', 'transcatheter aortic-valve replacement (TAVR', 'rivaroxaban', 'rivaroxaban group) or aspirin', 'aspirin', 'Rivaroxaban', 'Transcatheter Aortic-Valve Replacement']","['major, disabling, or life-threatening bleeding', 'death or a first thromboembolic event', 'Major, disabling, or life-threatening bleeding', 'risk of bleeding', 'thromboembolic events', 'risk of death or thromboembolic complications', 'composite of death or thromboembolic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C3653500', 'cui_str': 'Direct Factor Xa Inhibitors'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1644.0,0.430588,"A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).
","[{'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ana H C', 'Initials': 'AHC', 'LastName': 'Guimarães', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Annapoorna', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'von Lewinski', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schäfer', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Seeger', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomitzek', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Volkl', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zazula', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Ronald G M', 'Initials': 'RGM', 'LastName': 'van Amsterdam', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1911425']
866,31852287,Intravaginal administration of isosorbide mononitrate for cervical ripening in prolonged pregnancy: a randomised clinical trial.,"Prolonged pregnancies are associated with foetal and neonatal complications. This study was performed to evaluate the efficacy of intravaginal isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. 122 pregnant women were recruited. Women were assigned to 25 µg sublingual misoprostol plus 40 mg isosorbide mononitrate or placebo. Statistical analysis was done using SPSS software (version 23) and  T -test, Mann-Whitney and Chi-square test.  p  ≤ .05 was considered significant. The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02). The mean time from beginning of cervical ripening to the beginning of active phase of Labour was comparable between two groups ( p  = .274). The misoprostol plus IMN group had significantly shorter interval from the beginning of cervical ripening to the time of delivery. Isosorbide mononitrate in combination with misoprostol has a promising effect on cervical ripening and progress in labour.IMPACT STATEMENT What is already known on this subject?  Prolonged pregnancy is associated with foetal, neonatal, and maternal complications. Because of these complications, many obstetricians tend toward the induction of prolonged pregnancies to reduce perinatal morbidity and mortality. Isosorbide mononitrate is a nitric oxide donor agent which is used vaginally for cervical ripening in term pregnancies resulting in various outcomes. What do the results of this study add?  Isosorbide mononitrate in combination with misoprostol had a greater effect on cervical ripening and progress in labour than misoprostol alone in prolonged pregnancies. What are the implications of these findings for clinical practice and/or further research?  According to results of the current study; using isosorbide mononitrate in combination with misoprostol could enhance successful vaginal delivery in prolonged pregnancy. Evaluation of maternal satisfaction by using this protocol is recommended in future studies.",2020,The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02).,"['prolonged pregnancy', '122 pregnant women were recruited', 'prolonged pregnancies']","['misoprostol plus IMN', 'IMPACT', 'misoprostol', 'Isosorbide mononitrate', 'isosorbide mononitrate in combination with misoprostol', 'isosorbide mononitrate', 'IMN plus misoprostol', 'sublingual misoprostol plus 40\u2009mg isosorbide mononitrate or placebo', 'misoprostol plus placebo', 'intravaginal isosorbide mononitrate (IMN', 'Isosorbide']","['mean time', 'successful vaginal delivery', 'cervical ripening and progress in labour', 'mean time between beginning of cervical ripening to Bishop score >6', 'perinatal morbidity and mortality']","[{'cui': 'C0032993', 'cui_str': 'Pregnancy, Prolonged'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0064079', 'cui_str': 'Isosorbide Mononitrate'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0022251', 'cui_str': 'Isosorbide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",122.0,0.214301,The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group ( p  = .02).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirteimouri', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Pourali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Najaf Najafi', 'Affiliation': 'Department of Social Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghaffarian Omid', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1669546']
867,31829521,Sequential parallel comparison design with two coprimary endpoints.,"A placebo-controlled randomized clinical trial is required to demonstrate that an experimental treatment is superior to its corresponding placebo on multiple coprimary endpoints. This is particularly true in the field of neurology. In fact, clinical trials for neurological disorders need to show the superiority of an experimental treatment over a placebo in two coprimary endpoints. Unfortunately, these trials often fail to detect a true treatment effect for the experimental treatment versus the placebo owing to an unexpectedly high placebo response rate. Sequential parallel comparison design (SPCD) can be used to address this problem. However, the SPCD has not yet been discussed in relation to clinical trials with coprimary endpoints. In this article, our aim was to develop a hypothesis-testing method and a method for calculating the corresponding sample size for the SPCD with two coprimary endpoints. In a simulation, we show that the proposed hypothesis-testing method achieves the nominal type I error rate and power and that the proposed sample size calculation method has adequate power accuracy. In addition, the usefulness of our methods is confirmed by returning to an SPCD trial with a single primary endpoint of Alzheimer disease-related agitation.",2020,"In a simulation, we show that the proposed hypothesis-testing method achieves the nominal type I error rate and power and that the proposed sample size calculation method has adequate power accuracy.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.170886,"In a simulation, we show that the proposed hypothesis-testing method achieves the nominal type I error rate and power and that the proposed sample size calculation method has adequate power accuracy.","[{'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Homma', 'Affiliation': 'Graduate School of Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Daimon', 'Affiliation': 'Department of Biostatistics, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Pharmaceutical statistics,['10.1002/pst.1987']
868,31725441,Simulation-Based Team Leadership Training Improves Team Leadership During Actual Trauma Resuscitations: A Randomized Controlled Trial.,"OBJECTIVES


Trauma resuscitations are complex critical care events that present patient safety-related risk. Simulation-based leadership training is thought to improve trauma care; however, there is no robust evidence supporting the impact of leadership training on clinical performance. The objective of this study was to assess the clinical impact of simulation-based leadership training on team leadership and patient care during actual trauma resuscitations.
DESIGN


Randomized controlled trial.
SETTING


Harborview Medical Center (level 1 trauma center).
SUBJECTS


Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed.
INTERVENTIONS


Subjects were randomized to a 4-hour simulation-based leadership training (intervention) or standard orientation (control) condition.
MEASUREMENTS AND MAIN RESULTS


Participant-led actual trauma resuscitations were video recorded and coded for leadership behaviors and patient care. We used random coefficient modeling to account for the nesting effect of multiple observations within residents and to test for post-training group differences in leadership behaviors while controlling for pre-training behaviors, Injury Severity Score, postgraduate training year, and days since training occurred. Sixty participants completed the study. There was a significant difference in post-training leadership behaviors between the intervention and control conditions (b1 = 4.06, t (55) = 6.11, p < 0.001; intervention M = 11.29, SE = 0.66, 95% CI, 9.99-12.59 vs control M = 7.23, SE = 0.46, 95% CI, 6.33-8.13, d = 0.92). Although patient care was similar between conditions (b = 2.00, t (55) = 0.99, p = 0.325; predicted means intervention M = 62.38, SE = 2.01, 95% CI, 58.43-66.33 vs control M = 60.38, SE = 1.37, 95% CI, 57.69-63.07, d = 0.15), a test of the mediation effect between training and patient care suggests leadership behaviors mediate an effect of training on patient care with a significant indirect effect (b = 3.44, 95% CI, 1.43-5.80). Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001).
CONCLUSIONS


Leadership training resulted in the transfer of complex skills to the clinical environment and may have an indirect effect on patient care through better team leadership.",2020,"Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001).
","['Harborview Medical Center (level 1 trauma center', 'Sixty participants completed the study', 'Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed']","['4-hour simulation-based leadership training (intervention) or standard orientation (control) condition', 'Simulation-based leadership training', 'Simulation-Based Team Leadership Training Improves Team Leadership', 'leadership training', 'simulation-based leadership training', 'Leadership training']",['post-training leadership behaviors'],"[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",60.0,0.142068,"Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001).
","[{'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Fernandez', 'Affiliation': 'Center for Experiential Learning and Simulation, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, FL.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Rosenman', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Olenick', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Misisco', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Brolliar', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Chipman', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Vrablik', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Kalynych', 'Affiliation': 'Department of Emergency Medicine, Office of Educational Affairs, University of Florida College of Medicine - Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Arbabi', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, WA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD.'}, {'ForeName': 'Steve W J', 'Initials': 'SWJ', 'LastName': 'Kozlowski', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI.'}, {'ForeName': 'Georgia T', 'Initials': 'GT', 'LastName': 'Chao', 'Affiliation': 'Department of Management, Michigan State University, East Lansing, MI.'}]",Critical care medicine,['10.1097/CCM.0000000000004077']
869,31014947,Loss to follow-up after laparoscopic gastric bypass surgery - a post hoc analysis of a randomized clinical trial.,"BACKGROUND


Follow-up after bariatric surgery is important if we are to identify long-term complications at an early stage and thereby improve long-term outcome. Despite great efforts, many patients are lost to follow-up. Definition of characteristics of patients failing to attend follow-up could help in defining a specific group for whom extra resources may be applied to improve the situation.
OBJECTIVES


To identify characteristics of patients failing to attend follow-up 2 years after laparoscopic gastric bypass surgery.
SETTING


Multicenter study, Sweden.
METHODS


Post hoc analysis of a randomized clinical trial in which preoperative patient characteristics and postoperative outcome measures were compared between patients who attended or did not attend a 2-year follow-up visit after laparoscopic gastric bypass surgery.
RESULTS


Of the 2495 patients included, 260 did not attend a 2-year follow-up visit. Factors associated with higher risk for failure to attend were younger age (adjusted odds ratio [OR] .96, 95% confidence interval [CI] .94-.98/yr, P < .001); male sex (adjusted OR 2.34, 95% CI 1.51-3.63, P < .001); depression (adjusted OR 1.61, 95% CI 1.05-2.47, P = .029); history of smoking (adjusted OR 1.78, 95% CI 1.26-2.51, P = .001); being single (adjusted OR 1.47, 95% CI 1.03-2.11, P = .036); and being first-generation immigrant (adjusted OR 1.74, 95% CI 1.05-2.88; P = .032). Elementary occupation (adjusted OR .42, 95% CI .18-.99, P = .047) was associated with lower risk.
CONCLUSION


These findings indicate that there are preoperative characteristics that may help in identifying patients likely to fail to attend follow-up visits after laparoscopic gastric bypass surgery. Special effort should be made to inform these patients of the importance of follow-up and to encourage them to attend.",2019,"Elementary occupation (adjusted OR .42, 95% CI .18-.99, P = .047) was associated with lower risk.
","['2495 patients included, 260 did not attend a 2-year follow-up visit', 'patients who attended or did not attend a 2-year follow-up visit after laparoscopic gastric bypass surgery', 'Multicenter study, Sweden', 'patients failing to attend follow-up 2 years after laparoscopic gastric bypass surgery']",['laparoscopic gastric bypass surgery'],"['history of smoking', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",2495.0,0.22726,"Elementary occupation (adjusted OR .42, 95% CI .18-.99, P = .047) was associated with lower risk.
","[{'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Kedestig', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stenberg', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. Electronic address: erik.stenberg@regionorebrolan.se.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.03.010']
870,31014071,Smartphone-Based Interventions to Foster Simple Activity and Personal Satisfaction in People With Advanced Alzheimer's Disease.,"OBJECTIVES


This study assessed a smartphone-based program to promote practical and mildly demanding arm responses and personal satisfaction and increase physical exertion (heart rates) in people with advanced Alzheimer's disease.
METHODS


The program relied on a Samsung Galaxy A3 smartphone with Android 6.0 operating system. Two groups of 10 and 11 participants, respectively, were assigned different responses (ie, placing cards into an elevated box and moving bottles with water from a table into a container). Responses activated the smartphone, which produced brief periods of preferred stimulation. Lack of responding led the smartphone to produce a verbal prompt.
RESULTS


All participants had significant increases in independent response frequencies, level of personal satisfaction, and heart rates during program sessions as opposed to baseline or control sessions.
CONCLUSION


A smartphone-based program may help people with advanced Alzheimer's disease increase independent occupation with possible benefits in terms of satisfaction and physical condition.",2019,"All participants had significant increases in independent response frequencies, level of personal satisfaction, and heart rates during program sessions as opposed to baseline or control sessions.
","[""people with advanced Alzheimer's disease"", ""People With Advanced Alzheimer's Disease""]","['Smartphone-Based Interventions to Foster Simple Activity and Personal Satisfaction', 'smartphone-based program']","['response frequencies, level of personal satisfaction, and heart rates', 'physical exertion (heart rates']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0031206', 'cui_str': 'Personal Satisfaction'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031206', 'cui_str': 'Personal Satisfaction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}]",,0.0677506,"All participants had significant increases in independent response frequencies, level of personal satisfaction, and heart rates during program sessions as opposed to baseline or control sessions.
","[{'ForeName': 'Giulio E', 'Initials': 'GE', 'LastName': 'Lancioni', 'Affiliation': 'University of Bari, Bari, Italy.'}, {'ForeName': 'Nirbhay N', 'Initials': 'NN', 'LastName': 'Singh', 'Affiliation': 'Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': ""O'Reilly"", 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sigafoos', 'Affiliation': 'Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Fiora', 'Initials': 'F', 'LastName': ""D'Amico"", 'Affiliation': 'Silver House Health and Care Services, Bari, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Turnone', 'Affiliation': 'Silver House Health and Care Services, Bari, Italy.'}, {'ForeName': 'Dominga', 'Initials': 'D', 'LastName': 'Laporta', 'Affiliation': 'The Other House Center (Segesta), Bari, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Scordamaglia', 'Affiliation': 'The Other House Center (Segesta), Bari, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Pinto', 'Affiliation': 'Alzheimer Center, Bisceglie, Italy.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317519844144']
871,31402072,A patient- and assessor-blinded randomized controlled trial of axillary reverse mapping (ARM) in patients with early breast cancer.,"BACKGROUND


Axillary lymph node dissection (ALND) in breast cancer patients is infamous for its accompanying morbidity. Selective preservation of upper extremity lymphatic drainage and accompanying lymph nodes crossing the axillary basin - currently resected during a standard ALND - has been proposed as a valuable surgical refinement.
METHODS


Peroperative Axillary Reversed Mapping (ARM) was used for selective preservation of upper extremity lymphatic drainage. A multicentre patient- and assessor-blinded randomized study was performed in clinical node negative, sentinel node positive early breast cancer patients. Patients were randomized to undergo either standard-ALND or ARM-ALND. Primary outcome was the presence of surgery-related lymphedema at six, 12 and 24 months post-operatively. Secondary outcomes included patient reported and objective signs and symptoms of lymphedema, pain, paraesthesia, numbness, loss of shoulder mobility, quality of life and axillary recurrence risk.
RESULTS


No significant differences were found between both groups using the water displacement method with respect to measured lymphedema. ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p < 0.05). No axillary recurrence was found in both groups.
CONCLUSIONS


In contrast to results of volumetric measurement, patient reported outcomes support selective sparing of the upper extremity lymphatic drainage using ARM as valuable surgical refinement in case of ALND in clinically node negative, sentinel node positive early breast cancer. If completion ALND in clinically node negative, sentinel node positive early breast cancer is considered, selective sparing of upper extremity axillary lymphatics by implementing ARM should be carried out in order to reduce morbidity.",2020,"ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p < 0.05).","['sentinel node positive early breast cancer patients', 'breast cancer patients', 'patients with early breast cancer']","['standard-ALND or ARM-ALND', 'axillary reverse mapping (ARM', 'Peroperative Axillary Reversed Mapping (ARM']","['axillary recurrence', 'lymphedema', 'patient reported and objective signs and symptoms of lymphedema, pain, paraesthesia, numbness, loss of shoulder mobility, quality of life and axillary recurrence risk', 'presence of surgery-related lymphedema', 'complaints of lymphedema']","[{'cui': 'C0677944', 'cui_str': 'Signal node (disorder)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}]","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]",,0.0793643,"ARM-ALND resulted in less reported complaints of lymphedema at six, 12 and 24 months postoperatively (p < 0.05).","[{'ForeName': 'Martinus A', 'Initials': 'MA', 'LastName': 'Beek', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, the Netherlands. Electronic address: MBeek@amphia.nl.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Gobardhan', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Elisabeth G', 'Initials': 'EG', 'LastName': 'Klompenhouwer', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marian B', 'Initials': 'MB', 'LastName': 'Menke-Pluijmers', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Steenvoorde', 'Affiliation': 'Department of Surgery, Medisch Spectrum Twente Hospital, Twente, the Netherlands.'}, {'ForeName': 'Jos Ws', 'Initials': 'JW', 'LastName': 'Merkus', 'Affiliation': 'Department of Surgery, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Harm Jt', 'Initials': 'HJ', 'LastName': 'Rutten', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands; Department of Surgery, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Adri C', 'Initials': 'AC', 'LastName': 'Voogd', 'Affiliation': 'Department of Epidemiology, Faculty of Health Medicine and Life Sciences, Research Institute Growth and Development (GROW), Maastricht University, Maastricht, the Netherlands; Department of Research, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands.'}, {'ForeName': 'Ernest Jt', 'Initials': 'EJ', 'LastName': 'Luiten', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, the Netherlands.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.08.003']
872,30965355,Behavioural and cognitive outcomes following an early stress-reduction intervention for very preterm and extremely preterm infants.,"BACKGROUND


The landmark findings of the Mother-Infant Transaction Program (MITP) showing improved neurodevelopment of preterm infants following parent-sensitivity training delivered in the neonatal intensive care unit have not been consistently replicated. This study evaluated an MITP-type intervention in terms of neurobehavioural development to preschool age.
METHODS


A randomised controlled trial involved 123 very preterm and extremely preterm infants allocated to either a parent-sensitivity intervention (PremieStart, n = 60) or to standard care (n = 63). When children were 2 and 4.5 years corrected age, parents completed the Child Behavior Checklist (CBCL). General development was assessed at 2 years with the Bayley Scales of Infant Development (Bayley-III). At 4.5 years, cognitive functioning was assessed with the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) and executive functioning with the NEPSY-II.
RESULTS


There were no significant between-group differences in behaviour problems at 2 or 4.5 years, general development at 2 years, or cognitive and executive functioning at 4.5 years.
CONCLUSION


Advances in the quality of neonatal intensive care may mean that MITP-type interventions now have limited additional impact on preterm infants' long-term neurobehavioural outcomes. The gestational age of infants and the exact timing of intervention may also affect its efficacy.",2019,"There were no significant between-group differences in behaviour problems at 2 or 4.5 years, general development at 2 years, or cognitive and executive functioning at 4.5 years.
","['very preterm and extremely preterm infants', '123 very preterm and extremely preterm infants allocated to either a']","['parent-sensitivity intervention (PremieStart, n\u2009=\u200960) or to standard care', 'early stress-reduction intervention', 'Mother-Infant Transaction Program (MITP', 'MITP-type intervention']","['Child Behavior Checklist (CBCL', 'Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) and executive functioning with the NEPSY-II', 'Behavioural and cognitive outcomes', 'behaviour problems', 'general development at 2 years, or cognitive and executive functioning', 'cognitive functioning']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2828074', 'cui_str': 'Wechsler Preschool and Primary Scale of Intelligence'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0424601', 'cui_str': 'General development (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",123.0,0.129551,"There were no significant between-group differences in behaviour problems at 2 or 4.5 years, general development at 2 years, or cognitive and executive functioning at 4.5 years.
","[{'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Milgrom', 'Affiliation': 'Parent-Infant Research Institute, Department of Clinical & Health Psychology, Austin Health, Melbourne, VIC, 3081, Australia.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Martin', 'Affiliation': 'Research School of Psychology, The Australian National University, Canberra, ACT, 2000, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Newnham', 'Affiliation': 'Parent-Infant Research Institute, Department of Clinical & Health Psychology, Austin Health, Melbourne, VIC, 3081, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Holt', 'Affiliation': 'Parent-Infant Research Institute, Department of Clinical & Health Psychology, Austin Health, Melbourne, VIC, 3081, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Anderson', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, Melbourne, VIC, 3800, Australia.'}, {'ForeName': 'Rod W', 'Initials': 'RW', 'LastName': 'Hunt', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Melbourne, VIC, 3052, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reece', 'Affiliation': 'Discipline of Psychological Sciences, Australian College of Applied Psychology, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Ferretti', 'Affiliation': 'Parent-Infant Research Institute, Department of Clinical & Health Psychology, Austin Health, Melbourne, VIC, 3081, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Achenbach', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, 05405, USA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Gemmill', 'Affiliation': 'Parent-Infant Research Institute, Department of Clinical & Health Psychology, Austin Health, Melbourne, VIC, 3081, Australia. alan.gemmill@austin.org.au.'}]",Pediatric research,['10.1038/s41390-019-0385-9']
873,30801744,Anti-Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta.,"OBJECTIVE


The stability of anti-Müllerian hormone (AMH) across and between menstrual cycles has been the subject of debate. The objective of this analysis was to study the inter- and intracycle variability in repeated measurements and assess the impact on an individualized gonadotropin dosing algorithm and predicted oocyte yield.
DESIGN


Retrospective analysis of repeat AMH measures from a randomized controlled trial.
PATIENTS


A total of 1326 women aged 18-40 years.
MEASUREMENTS


Serum AMH levels at screening and at cycle day 2-3 in up to three ovarian stimulation cycles. AMH variability and its impact on gonadotropin dose and the predicted number of oocytes.
RESULTS


Repeat serum AMH measurements were strongly correlated within individual women (correlation coefficient 0.92). AMH exhibited limited within-subject variation (coefficient of variation 23%), a small time-related decline (mean 6% decrease/y), but no systematic variation across the menstrual cycle. Irrespective of whether the AMH screening value or the AMH at the initiation of ovarian stimulation was used, for women with an AMH level <15 pmol/L, 93% would receive the same gonadotropin dose and attain an identical number of oocytes in 97% of cases. For women with an AMH level ≥15 pmol/L, 80% would receive an individualized dose within ±1.5 μg and 90% would attain ±1 oocyte.
CONCLUSION


AMH variability had limited impact on individualized gonadotropin dosing, with 95% of women predicted to obtain an oocyte yield that does not vary beyond 1 oocyte count, irrespective of whether a random or early follicular AMH measurement was used to determine the individualized gonadotropin dose.",2019,"Irrespective of whether the AMH screening value or the AMH at the initiation of ovarian stimulation was used, for women with an AMH level <15 pmol/L, 93% would receive the same gonadotropin dose and attain an identical number of oocytes in 97% of cases.",['1326 women aged 18-40\xa0years'],[],"['Serum AMH levels', 'serum AMH measurements', 'AMH variability']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",1326.0,0.132623,"Irrespective of whether the AMH screening value or the AMH at the initiation of ovarian stimulation was used, for women with an AMH level <15 pmol/L, 93% would receive the same gonadotropin dose and attain an identical number of oocytes in 97% of cases.","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Larsson', 'Affiliation': 'Biometrics - Global Clinical R&D, Ferring Pharmaceuticals, Copenhagen, Denmark.'}, {'ForeName': 'Bernadette M J L', 'Initials': 'BMJL', 'LastName': 'Mannaerts', 'Affiliation': 'Reproductive Health - Global Clinical R&D, Ferring Pharmaceuticals, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Nyboe Andersen', 'Affiliation': 'Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bart C J M', 'Initials': 'BCJM', 'LastName': 'Fauser', 'Affiliation': 'Emeritus Professor University of Utrecht, Utrecht, The Netherlands.'}]",Clinical endocrinology,['10.1111/cen.13956']
874,31718211,Effects of a low-carbohydrate diet on performance and body composition in trained cyclists.,"Introduction


Previous evidence suggests that low-carbohydrate diets may improve body composition and performance relative to body weight in endurance athletes. This has been the first study that has attempted to evaluate the utility of low-carbohydrate diets in a sample of eleven trained and experienced road cyclists who consumed 10% of their caloric intake in the form of carbohydrates during four weeks while maintaining a neutral energy balance (50 kcal/kg/day). Body composition was evaluated through an electrical impedance assessment before and after the intervention while maximal power output (5 and 20 min) was measured on a bike trainer by following a standardized protocol and in the same room conditions for all the participants. The study was performed during the preseason, when the subjects could abstain from performing high-intensity workouts. The participants, eleven men aged 31 ± 5 years, performed four weekly 150 min training sessions at submaximal intensities and received nutritional support from a certified sport nutritionist. The intervention resulted in reduced total weight (-2.51 kg) and body fat percentage (2.42%), and improved relative power (+0.2 w/kg for 20 min and +0.25 w/kg for 5 min) values while absolute power remained unchanged. The results suggest that low-carbohydrate diets could be used in order to induce changes in body composition and improve relative power during the preseason. However, future research with larger sample sizes and a control group is needed in order to validate the results.",2019,"The intervention resulted in reduced total weight (-2.51 kg) and body fat percentage (2.42%), and improved relative power (+0.2 w/kg for 20 min and +0.25 w/kg for 5 min) values while absolute power remained unchanged.","['trained cyclists', 'participants, eleven men aged 31 ± 5 years', 'endurance athletes']","['low-carbohydrate diets', 'nutritional support from a certified sport nutritionist', 'low-carbohydrate diet']","['relative power', 'performance and body composition', 'body composition and improve relative power', 'Body composition', 'reduced total weight', 'body composition and performance relative to body weight', 'body fat percentage']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",150.0,0.0214168,"The intervention resulted in reduced total weight (-2.51 kg) and body fat percentage (2.42%), and improved relative power (+0.2 w/kg for 20 min and +0.25 w/kg for 5 min) values while absolute power remained unchanged.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sitko', 'Affiliation': 'Universidad de Zaragoza.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Cirer-Sastre', 'Affiliation': ""Institut Nacional d'Educació Física de Catalunya (INEFC). Universitat de Lleida (UdL).""}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'López Laval', 'Affiliation': 'Universidad de Zaragoza.'}]",Nutricion hospitalaria,['10.20960/nh.02762']
875,29796932,"Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study.","PURPOSE


To investigate the effects of eating wholegrain rye bread with high or low amounts of phytate on iron status in women under free-living conditions.
METHODS


In this 12-week, randomized, parallel-design intervention study, 102 females were allocated into two groups, a high-phytate-bread group or a low-phytate-bread group. These two groups were administered: 200 g of blanched wholegrain rye bread/day, or 200 g dephytinized wholegrain rye bread/day. The bread was administered in addition to their habitual daily diet. Iron status biomarkers and plasma alkylresorcinols were analyzed at baseline and post-intervention.
RESULTS


Fifty-five females completed the study. In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05). In the low-phytate bread group (n = 24) there were significant decreases in both ferritin (mean = 12%; from 32 ± 7 to 27 ± 6 µg/L, geometric mean ± SEM, p < 0.018) and total body iron (mean = 12%; from 6.9 ± 1.4 to 5.4 ± 1.1 mg/kg, p < 0.035). Plasma alkylresorcinols indicated that most subjects complied with the intervention.
CONCLUSIONS


In Swedish females of reproductive age, 12 weeks of high-phytate wholegrain bread consumption had no effect on iron status. However, consumption of low-phytate wholegrain bread for 12 weeks resulted in a reduction of markers of iron status. Although single-meal studies clearly show an increase in iron bioavailability from dephytinization of cereals, medium-term consumption of reduced phytate bread under free-living conditions suggests that this strategy does not work to improve iron status in healthy women of reproductive age.",2019,In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05).,"['women under free-living conditions', '102 females', 'healthy Swedish females', 'Fifty-five females completed the study', 'healthy women of reproductive age']","['wholegrain bread', 'high-phytate-bread group or a low-phytate-bread group', 'blanched wholegrain rye bread/day, or 200', 'eating wholegrain rye bread with high or low amounts of phytate']","['iron status biomarkers', 'ferritin', 'iron bioavailability', 'total body iron', 'Iron status biomarkers and plasma alkylresorcinols', 'Plasma alkylresorcinols', 'reduction of markers of iron status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086808', 'cui_str': 'Phytate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0948786', 'cui_str': 'Blanching'}, {'cui': 'C0452545', 'cui_str': 'Rye bread (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",102.0,0.039502,In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Gothenburg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-018-1722-1']
876,30693423,Methylphenidate modifies activity in the prefrontal and parietal cortex accelerating the time judgment.,"Methylphenidate produces its effects via actions on cortical areas involved with attention and working memory, which have a direct role in time estimation judgment tasks. In particular, the prefrontal and parietal cortex has been the target of several studies to understand the effect of methylphenidate on executive functions and time interval perception. However, it has not yet been studied whether acute administration of methylphenidate influences performance in time estimation task and the changes in alpha band absolute power in the prefrontal and parietal cortex. The current study investigates the influence of the acute use of methylphenidate in both performance and judgment in the time estimation interpretation through the alpha band absolute power activity in the prefrontal and parietal cortex. This is a double-blind, crossover study with a sample of 32 subjects under control (placebo) and experimental (methylphenidate) conditions with absolute alpha band power analysis during a time estimation task. We observed that methylphenidate does not influence task performance (p > 0.05), but it increases the time interval underestimation by over 7 s (p < 0.001) with a concomitant decrease in absolute alpha band power in the ventrolateral prefrontal cortex and dorsolateral prefrontal cortex and parietal cortex (p < 0.001). Acute use of methylphenidate increases the time interval underestimation, consistent with reduced accuracy of the internal clock mechanisms. Furthermore, acute use of methylphenidate influences the absolute alpha band power over the dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, and parietal cortex.",2019,"We observed that methylphenidate does not influence task performance (p > 0.05), but it increases the time interval underestimation by over 7 s (p < 0.001) with a concomitant decrease in absolute alpha band power in the ventrolateral prefrontal cortex and dorsolateral prefrontal cortex and parietal cortex (p < 0.001).",['32 subjects under'],"['methylphenidate', 'control (placebo) and experimental (methylphenidate', 'Methylphenidate']","['absolute alpha band power in the ventrolateral prefrontal cortex and dorsolateral prefrontal cortex and parietal cortex', 'absolute alpha band power over the dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, and parietal cortex', 'executive functions and time interval perception', 'time interval underestimation', 'task performance']",[],"[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",32.0,0.0320789,"We observed that methylphenidate does not influence task performance (p > 0.05), but it increases the time interval underestimation by over 7 s (p < 0.001) with a concomitant decrease in absolute alpha band power in the ventrolateral prefrontal cortex and dorsolateral prefrontal cortex and parietal cortex (p < 0.001).","[{'ForeName': 'Tiago Lopes', 'Initials': 'TL', 'LastName': 'Farias', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil. tiago_farias20@hotmail.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil. victormarinhophb@hotmail.com.'}, {'ForeName': 'Valécia', 'Initials': 'V', 'LastName': 'Carvalho', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Kaline', 'Initials': 'K', 'LastName': 'Rocha', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Paulo Ramiler Alves', 'Initials': 'PRA', 'LastName': 'da Silva', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Silva', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Ariel Soares', 'Initials': 'AS', 'LastName': 'Teles', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Daya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'Brain Mapping and Functionality Laboratory, Federal University of Piauí, Parnaíba, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Silva-Junior', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology and Brain Mapping Laboratory, Federal University of Piauí, Av. São Sebastião, 2819, Bairro São Benedito, Parnaíba, Piauí, CEP: 64202-020, Brazil.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-018-3699-1']
877,31000508,Combined subconjunctival injection of dexamethasone for the management of acute primary angle closure: a randomised controlled trial.,"PURPOSE


To investigate whether the combined subconjunctival injection of dexamethasone can accelerate the decrease in intraocular pressure (IOP) in acute primary angle closure (APAC)-affected eyes.
METHODS


42 patients with APAC were recruited for a randomised controlled trial. These patients were separated into two groups: the injection group (21 patients) and the control group (21 patients). The injection group was subjected to a subconjunctival injection with 2.5 mg dexamethasone. Other drug treatments were the same with the control group. The follow-up was at 0, 3, 6, 12 and 24 hours after injection. The outcome measures include IOP and intraocular inflammation variables.
RESULTS


The IOP was significantly decreased in both groups after treatment. However, 24 hours after the initial treatment, the IOP of the injection group was significantly lower compared with the control group (p = 0.017). Kaplan-Meier survival curve analysis showed that the total success rate of the injection group and the control group were 79.7% and 54.9% at 24 hours after treatment (p = 0.027), respectively. For the comparison of anterior chamber inflammation, the severity of conjunctival erythema, ciliary flush and pain in the injection group was also lower than that in the control group at 24 hours after treatment(p = 0.012, p = 0.048 and p = 0.013, respectively). No statistical significance was found between the two groups regarding the anterior chamber cells, anterior chamber flare and photophobia.
CONCLUSION


The combined subconjunctival injection of dexamethasone for the management of APAC eyes can significantly accelerate the relief of high IOP, and therefore, improve the success rate of treatment.",2020,"No statistical significance was found between the two groups regarding the anterior chamber cells, anterior chamber flare and photophobia.
","['acute primary angle closure (APAC)-affected eyes', '42 patients with APAC', 'acute primary angle closure']","['subconjunctival injection with 2.5\u2009mg dexamethasone', 'dexamethasone']","['total success rate', 'IOP', 'severity of conjunctival erythema, ciliary flush and pain', 'anterior chamber cells, anterior chamber flare and photophobia', 'intraocular pressure (IOP', 'IOP and intraocular inflammation variables']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells (finding)'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare (finding)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",42.0,0.0488493,"No statistical significance was found between the two groups regarding the anterior chamber cells, anterior chamber flare and photophobia.
","[{'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University Zhongshan Ophthalmic Center, Guangzhou, China.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University Zhongshan Ophthalmic Center, Guangzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University Zhongshan Ophthalmic Center, Guangzhou, China.'}, {'ForeName': 'Xiulan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University Zhongshan Ophthalmic Center, Guangzhou, China zhangxl2@mail.sysu.edu.cn.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313473']
878,30920880,"Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial.","PURPOSE


This trial aimed to assess the efficacy and safety of the paclitaxel plus fluorouracil regimen versus the cisplatin plus fluorouracil regimen in definitive concurrent chemoradiotherapy (dCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).
PATIENTS AND METHODS


Patients with locally advanced ESCC were enrolled and randomly assigned to either the paclitaxel plus fluorouracil group or the cisplatin plus fluorouracil group. The patients in the paclitaxel plus fluorouracil group were treated with paclitaxel and fluorouracil one cycle per week in dCRT for five cycles followed by paclitaxel and fluorouracil one cycle per month in consolidation chemotherapy for two cycles. The patients in the cisplatin/5-fluorouracil group were treated with cisplatin and fluorouracil one cycle per month in dCRT for two cycles followed by two cycles in consolidation chemotherapy. The radiotherapy dose was 61.2 Gy delivered in 34 fractions. The primary end point was 3-year overall survival (OS).
RESULTS


Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015. The median follow-up of the surviving patients was 48.7 months (interquartile range, 42.6-60.9). The 3-year OS was 55.4% in the paclitaxel plus fluorouracil group and 51.8% in the cisplatin plus fluorouracil group (hazard ratio, 0.905 [95% CI, 0.698 to 1.172];  P  = .448). The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973 [95% CI, 0.762 to 1.243];  P  = .828). Compared with the cisplatin plus fluorouracil group, the paclitaxel plus fluorouracil group had significantly lower incidences of acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue ( P  < .05), but higher incidences of acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis ( P  < .05).
CONCLUSION


The paclitaxel plus fluorouracil regimen did not significantly prolong the OS compared with the standard cisplatin plus fluorouracil regimen in dCRT in patients with locally advanced ESCC.",2019,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","['Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015', 'Locally Advanced Esophageal Squamous Cell Cancer', 'patients with locally advanced ESCC', 'patients with locally advanced esophageal squamous cell carcinoma (ESCC', 'Patients with locally advanced ESCC']","['paclitaxel plus fluorouracil', 'cisplatin/5-fluorouracil', 'chemoradiotherapy (dCRT', 'Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil', 'radiotherapy', 'standard cisplatin plus fluorouracil', 'cisplatin plus fluorouracil regimen', 'paclitaxel and fluorouracil', 'Chemoradiotherapy', 'cisplatin plus fluorouracil', 'cisplatin and fluorouracil']","['OS', '3-year OS', '3-year progression-free survival', '3-year overall survival (OS', 'efficacy and safety', 'acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue', 'acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}]",436.0,0.0572158,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': '2 Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': '3 Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chaoyang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Huarong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': '5 The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '7 Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Saiquan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kuaile', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02122']
879,30982680,"Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation.","BACKGROUND


Angiotensin receptor and neprilysin inhibition (ARNI) has been shown to reduce cardiovascular mortality by 20% as compared with enalapril in a randomized controlled trial. However, there is a paucity of real-world data on the effects of ARNI in heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension.
METHODS


Between 2016 and 2017, we recruited 466 HFrEF patients treated with sacubitril/valsartan (Group A) and 466 patients managed with standard HF treatment without ARNI (Group B) in a HF referral center. Baseline characteristics and clinical outcomes were collected between both groups.
RESULTS


Baseline characteristics were comparable between the two groups. During a follow-up period of 15 months, death from cardiovascular causes or first unplanned hospitalization for HF occurred in 100 patients in Group A (21.5%) and 144 in Group B (30.9%, hazard ratio 0.66; 95% CI 0.51-0.85; p=0.001). The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients. Among patients with different chronic kidney disease stages and normotensive patients, treatment with sacubitril/valsartan showed more favorable outcomes than treatment with standard HF care without ARNI. However, in patients with baseline systolic blood pressure lower than 100mmHg, there were no significant differences of outcomes in both groups. Among Group A patients, escalation of sacubitril/valsartan was associated with better outcomes.
CONCLUSIONS


Our study demonstrated the effectiveness of sacubitril/valsartan on HFrEF patients in real world practice, including those with advanced renal impairment.",2019,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","['heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension', 'Group A) and 466 patients managed with', 'heart failure with reduced ejection fraction patients', '466 HFrEF patients treated with', 'Between 2016 and 2017', 'HFrEF patients in real world practice, including those with advanced renal impairment', 'patients with different chronic kidney disease stages and normotensive patients']","['standard HF treatment without ARNI', 'enalapril', 'Sacubitril/valsartan', 'sacubitril/valsartan', 'Angiotensin receptor and neprilysin inhibition (ARNI']","['baseline systolic blood pressure', 'death from cardiovascular causes or first unplanned hospitalization for HF', 'cardiovascular mortality', 'incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}]",466.0,0.062689,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","[{'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'An-Ning', 'Initials': 'AN', 'LastName': 'Feng', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Man-Cai', 'Initials': 'MC', 'LastName': 'Fong', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chao-Wen', 'Initials': 'CW', 'LastName': 'Hsueh', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Tsung', 'Initials': 'WT', 'LastName': 'Lai', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chih', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Farrer Park Hospital, Singapore.'}, {'ForeName': 'Chi-Nan', 'Initials': 'CN', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hung-Chuan', 'Initials': 'HC', 'LastName': 'Chang', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: adr@chgh.org.tw.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.03.010']
880,30981620,Follicle stimulating hormone or clomiphene citrate in intrauterine insemination with ovarian stimulation for unexplained subfertility: a role for treatment selection markers?,"RESEARCH QUESTION


Can women be identified, on the basis of baseline patient characteristics, as having better chances of an ongoing pregnancy with FSH instead of clomiphene citrate as stimulation agent in intrauterine insemination for unexplained subfertility?
DESIGN


A secondary analysis of a multicentre randomized controlled superiority trial; the SUPER study. Between July 2013 and March 2016, couples with unexplained subfertility undergoing intrauterine inemination (IUI) were allocated to an FSH or clomiphene citrate group. Female age, body mass index, duration of subfertility, primary versus secondary subfertility, antral follicle count and total motile count were assessed. For each of these factors, a logistic regression model was developed to assess if different estimated effects of FSH versus clomiphene citrate on ongoing pregnancy occurred within strata of each factor.
RESULTS


A total of 684 couples received 2259 IUI cycles; 338 couples were allocated to FSH, of which 84 conceived leading to ongoing pregnancy and 346 couples were allocated to clomiphene citrate, of which 71 conceived leading to ongoing pregnancy. None of the treatment selection markers was associated with better ongoing pregnancy chances after IUI with FSH compared with clomiphene citrate.
CONCLUSION


In couples with unexplained subfertility undergoing IUI, no baseline treatment selection markers could be identified to determine whether ovaries should be stimulated with FSH or clomiphene citrate.",2019,"None of the treatment selection markers was associated with better ongoing pregnancy chances after IUI with FSH compared with clomiphene citrate.
","['Between July 2013 and March 2016, couples with unexplained subfertility undergoing intrauterine inemination (IUI', 'intrauterine insemination with ovarian stimulation for unexplained subfertility', '684 couples received 2259 IUI cycles; 338 couples were allocated to FSH, of which 84 conceived leading to ongoing pregnancy and 346 couples', 'couples with unexplained subfertility undergoing IUI']","['FSH versus clomiphene citrate', 'clomiphene citrate', 'Follicle stimulating hormone or clomiphene citrate', 'FSH or clomiphene citrate', 'FSH']",['pregnancy chances'],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}]",684.0,0.0672252,"None of the treatment selection markers was associated with better ongoing pregnancy chances after IUI with FSH compared with clomiphene citrate.
","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Danhof', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Eekelen', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Repping', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mochtar', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam. Electronic address: m.h.mochtar@amc.uva.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.01.014']
881,30981618,Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this randomized controlled trial was to evaluate the safety and efficacy of neodymium: yttrium aluminum garnet laser treatment of lichen sclerosus (LS) by comparing it with topical corticosteroid treatment.
METHODS


A total of 40 female patients with vulvar LS were randomized 1:1 into a study (laser) group and a control (topical corticosteroids) group. The laser group received three laser treatments. Blinded evaluators evaluated biopsies and graded improvement on clinical photographs at baseline and at 3 months. Patients graded the intensity of symptoms on a 0 to 10 visual analogue scale at baseline and 1-, 3-, and 6-month follow-up. Patients also rated the tolerability of laser treatments, and side effects were monitored. (Canadian Task Force classification I) RESULTS: Laser treatment discomfort was on average 1.5 of 10 on the visual analogue scale. At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group. At 6-month follow-up, the improvement of symptoms in the laser group was still significant. The correct order of photographs (before and after treatment) was assigned significantly more often in the laser-treated patients compared with the control group.
CONCLUSION


Laser therapy for LS caused minimal patient discomfort during the treatment, with no adverse effects, and demonstrated better efficacy than in the control group, with significant improvement lasting up to 6 months. Laser therapy is a promising option for patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use.",2019,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","['patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use', 'Lichen Sclerosus', '40 female patients with vulvar LS']","['Non-ablative Laser Therapy', 'control (topical corticosteroids', 'Laser therapy', 'neodymium: yttrium aluminum garnet laser treatment']","['Laser treatment discomfort', 'safety and efficacy', 'minimal patient discomfort', 'tolerability of laser treatments, and side effects', 'LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction', 'intensity of symptoms on a 0 to 10 visual analogue scale', 'improvement of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023652', 'cui_str': 'Lichen Sclerosus'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0832864,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","[{'ForeName': 'Urška', 'Initials': 'U', 'LastName': 'Bizjak Ogrinc', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia. Electronic address: urska.bizjak-ogrinc@juna.si.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Senčar', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia.'}, {'ForeName': 'Boštjan', 'Initials': 'B', 'LastName': 'Luzar', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Adolf', 'Initials': 'A', 'LastName': 'Lukanović', 'Affiliation': 'Department of Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.01.023']
882,30846465,Analysis of the MILES cohort reveals determinants of disease progression and treatment response in lymphangioleiomyomatosis.,"INTRODUCTION


The Multicenter International Lymphangioleiomyomatosis (LAM) Efficacy of Sirolimus (MILES) trial revealed that sirolimus stabilised lung function in patients with moderately severe LAM. The purpose of this study was to further examine the MILES cohort for the effects of racial, demographic, clinical and physiological patient characteristics on disease progression and treatment response in LAM.
METHODS


MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian), bronchodilator responsiveness (present/absent), initial forced expiratory volume in 1 s (FEV 1 ; 51-70%  versus  ≤50% predicted) and tuberous sclerosis complex (TSC) association (yes/no). A linear mixed effects model was used to compare slope differences, and nonparametric tests were used to compare medians and proportions between treatment groups in each stratum.
RESULTS


In the MILES placebo group, pre-menopausal patients declined 5-fold faster than post-menopausal patients (mean±se FEV 1  slope -17±3  versus  -3±3 mL·month -1 ; p=0.003). Upon treatment with sirolimus, both the pre-menopausal (-17±3  versus  -1±2 mL·month -1 ; p<0.0001) and post-menopausal patients (-3±3  versus  6±3 mL·month -1 ; p=0.04) exhibited a beneficial response in mean±se FEV 1  slope compared with the placebo group. Race, LAM subtype, bronchodilator responsiveness or baseline FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group. Menopausal status and race had differential effects on the adverse event profile of sirolimus. Baseline serum vascular endothelial growth factor (VEGF)-D >600 pg·mL -1  identified subgroups of patients who were more likely to decline on placebo and respond to treatment with sirolimus.
CONCLUSIONS


In LAM patients, treatment with sirolimus is beneficial regardless of menopausal status, race, bronchodilator responsiveness, baseline FEV 1  or TSC association. Serum VEGF-D and menopausal status can help inform therapeutic decisions.",2019,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"['patients with moderately severe LAM', 'MILES subjects were stratified on the basis of menopausal status (pre-menopausal/post-menopausal), race (Asian/Caucasian']","['sirolimus', 'MILES placebo', 'placebo', 'Sirolimus (MILES', 'Lymphangioleiomyomatosis (LAM']","['rate of disease progression', 'Baseline serum vascular endothelial growth factor (VEGF)-D ', 'Serum VEGF-D and menopausal status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0751674', 'cui_str': 'Lymphangioleiomyomatosis'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.156081,FEV 1  did not impact the rate of disease progression in the placebo group or treatment response in the sirolimus group.,"[{'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Hye-Seung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Young', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lianne G', 'Initials': 'LG', 'LastName': 'Singer', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Barker', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Chapman', 'Affiliation': 'Cleveland Clinic, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Brantly', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stocks', 'Affiliation': 'University of Texas Health Sciences Center, Tyler, TX, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Lynch', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Goldberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Downey', 'Affiliation': 'National Jewish Health and the University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'Taveira-DaSilva', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Setchell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'McCormack', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02066-2018']
883,30970172,An Integrative Cognitive Behavioral Therapy Program for Adults With Migraine: A Feasibility Study.,"OBJECTIVE


To present a novel cognitive behavioral therapy program that was developed exclusively for adults with migraine, and to assess the feasibility of this program.
BACKGROUND


Unlike previous efforts, we combined different approaches of behavioral therapy into one program: relaxation therapy, cognitive behavioral therapy, trigger management.
METHODS


The treatment program consists of 7 sessions (including psychoeducation, lifestyle counseling, coping with fear of attacks, trigger management, and stress management). The research was conducted in a single-group study with N = 9 completers (age: M = 41.6, SD = 17.6 years; N = 8 female, N = 1 male; N = 5 migraine without aura, N = 2 migraine with aura, N = 2 chronic migraine). After each of the group therapy sessions, evaluation questionnaires were filled out, and individual qualitative interviews were conducted after completion of the program.
RESULTS


The treatment program was very well accepted. Every session was rated as comprehensible, and overall satisfaction with the sessions was high. Participants greatly appreciated having access to a specific treatment, exclusively addressing migraine.
CONCLUSIONS


The idea of combining several approaches of behavioral therapy into a specific treatment program for migraine seems to be feasible and promising. A randomized controlled trial to determine the efficacy of our program is currently running.",2019,"Every session was rated as comprehensible, and overall satisfaction with the sessions was high.","['Adults With Migraine', '9 completers (age', 'adults with migraine', 'M\xa0=\xa041.6, SD\xa0=\xa017.6 years; N\xa0=\xa08 female, N\xa0=\xa01 male; N\xa0=\xa05 migraine without aura, N\xa0=\xa02 migraine with aura, N\xa0=\xa02 chronic migraine']","['Integrative Cognitive Behavioral Therapy Program', 'cognitive behavioral therapy program']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}, {'cui': 'C0154723', 'cui_str': 'Migraine with Aura'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0116267,"Every session was rated as comprehensible, and overall satisfaction with the sessions was high.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Klan', 'Affiliation': 'Department of Psychology, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Liesering-Latta', 'Affiliation': 'Migraine and Headache Clinic Königstein, Königstein, Germany.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic Königstein, Königstein, Germany.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Martin', 'Affiliation': 'Research School of Psychology, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Department of Psychology, University of Mainz, Mainz, Germany.'}]",Headache,['10.1111/head.13532']
884,30949704,Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.,"OBJECTIVES


To explore the pharmacokinetics (PK) of oral and intravenous (iv) lefamulin after single and multiple doses, and the effect of food on bioavailability.
METHODS


Lefamulin PK was examined in four studies. In Study 1, PK was assessed in patients with acute bacterial skin and skin structure infections who received repeated iv lefamulin q12h (150 mg). In Study 2, a four-period crossover study, healthy subjects received a single dose of oral lefamulin [immediate-release (IR) tablet, 1 × 600 mg] in a fasted and fed state, oral lefamulin (capsule, 3 × 200 mg) in a fasted state, and iv lefamulin in a fasted state. In Study 3, a three-period crossover study, healthy males received a single oral lefamulin dose (IR) in the following states: fasted, fasted followed by a high-calorie meal 1 h post-dose, and fed. Study 4 had two parts; in part A, healthy males received a single lefamulin dose (IR) in a fasted and fed state; in part B, subjects received repeated doses of lefamulin (IR, q12h) or placebo. Adverse events (AEs) were recorded in each study.
RESULTS


Single and repeated dosing of iv and oral lefamulin resulted in comparable exposure. Intravenous and oral lefamulin (given fasted or with a meal 1 h post-dose) resulted in bioequivalence. Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state. All AEs were mild or moderate in severity, no serious AEs were reported, and no participant discontinued because of an AE.
CONCLUSIONS


The PK of lefamulin supports successful switch from iv to oral therapy; lefamulin was generally well tolerated.",2019,Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state.,"['healthy males', 'Study 4 had two parts; in part A, healthy males', 'patients with acute bacterial skin and skin structure infections', 'healthy subjects']","['oral lefamulin [immediate-release (IR) tablet, 1\u205f×\u205f600\u2009mg] in a fasted and fed state, oral lefamulin (capsule, 3\u205f×\u205f200\u2009mg) in a fasted state, and iv lefamulin', 'oral and intravenous (iv) lefamulin', 'lefamulin (IR, q12h) or placebo', 'single lefamulin dose (IR) in a fasted and fed state', 'Intravenous and oral lefamulin', 'single oral lefamulin', 'lefamulin q12h']","['Adverse events (AEs', 'Pharmacokinetics and tolerability of lefamulin', 'tolerated']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0529393,Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state.,"[{'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Prince', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lell', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Heilmayer', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, PA, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz087']
885,30949708,Prediction of lefamulin epithelial lining fluid penetration after intravenous and oral administration using Phase 1 data and population pharmacokinetics methods.,"OBJECTIVES


Lefamulin is a semi-synthetic intravenous and oral pleuromutilin antibiotic with activity against pathogens commonly associated with community-acquired bacterial pneumonia. Using data from two Phase 1 studies, a population pharmacokinetics (PPK) model for lefamulin in plasma and epithelial lining fluid (ELF) was constructed.
METHODS


Plasma pharmacokinetic (PK) data from a crossover, bioavailability, food-effect study and plasma and ELF PK data from a tissue penetration study in normal healthy volunteers were used to construct a PPK model for lefamulin. Model development involved refinement of a previous PPK model for intravenous and oral administration, followed by application of the model to plasma and ELF data from the tissue penetration study. The ELF penetration ratio of lefamulin was determined using model-based simulations.
RESULTS


The PPK analysis data set contained 1103 plasma and 12 ELF lefamulin concentrations from 32 subjects. A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles. The absorption rate was slower and bioavailability was decreased after a high-fat/high-calorie meal. ELF data were well described using first-order rate constants into and out of the ELF compartment. The median predicted lefamulin total-drug ELF AUC0-24/free-drug plasma AUC0-24 ratio was ∼5:1 after intravenous or oral administration.
CONCLUSIONS


The final PPK model allowed precise characterization of plasma and ELF exposures after intravenous and oral administration. The high ELF penetration ratio suggests that the penetration of lefamulin into the effect site is rapid and extensive, irrespective of route of administration.",2019,A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles.,['normal healthy volunteers'],[],"['absorption rate', 'median predicted lefamulin total-drug ELF AUC0-24/free-drug plasma AUC0-24 ratio', 'bioavailability', 'ELF penetration ratio of lefamulin']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0408722,A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Sujata M', 'Initials': 'SM', 'LastName': 'Bhavnani', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz088']
886,30919809,Efficacy and safety of perioperative tranexamic acid in elderly patients undergoing trochanteric fracture surgery: a randomised controlled trial.,"INTRODUCTION


Trochanteric fractures result in a high frequency of considerable blood loss, a high incidence of blood transfusions, and a high risk of perioperative morbidity and mortality in elderly patients. This study aimed to evaluate the efficacy and safety of a three-dose regimen of tranexamic acid on blood loss and transfusion rate in elderly patients with trochanteric fractures.
METHODS


Eligible patients with trochanteric fractures surgically treated by dynamic hip screw and proximal anti-rotating intramedullary nail between March 2016 and October 2017 were enrolled in the study. Patients were randomly assigned to receive 15 mg/kg intravenous tranexamic acid dissolved in 100 mL of saline (TXA group) or 100 mL of saline solution (placebo group) over 10 minutes before, during, and after surgery. Perioperative blood loss, obvious blood loss, and hidden blood loss in the two groups were calculated separately. Vascular events and patient mortality over 6 months' follow-up were noted.
RESULTS


In total, 176 patients were included. Compared with the placebo group (n=88), patients in the TXA group (n=88) had less blood loss: perioperative blood loss was 205.5 mL (P<0.001), obvious blood loss was 125 mL (P<0.001), and hidden blood loss was 76.5 mL (P<0.001); reduced incidence of blood transfusion (17% vs 35%, P=0.007); and shorter hospital stays (median [interquartile range], 7 [6-8] vs 8.5 [7.5-9] days, P<0.001).
CONCLUSION


Tranexamic acid significantly lowered perioperative blood loss and blood transfusion rate without an increased risk of venous thromboembolism or mortality in elderly patients with trochanteric fractures treated with dynamic hip screw or proximal anti-rotating intramedullary nail.",2019,"CONCLUSION


Tranexamic acid significantly lowered perioperative blood loss and blood transfusion rate without an increased risk of venous thromboembolism or mortality in elderly patients with trochanteric fractures treated with dynamic hip screw or proximal anti-rotating intramedullary nail.","['elderly patients with trochanteric fractures', 'between March 2016 and October 2017 were enrolled in the study', 'elderly patients with trochanteric fractures treated with', '176 patients were included', 'Eligible patients with trochanteric fractures surgically treated by', 'elderly patients undergoing trochanteric fracture surgery', 'elderly patients']","['dynamic hip screw and proximal anti-rotating intramedullary nail', 'placebo', 'dynamic hip screw or proximal anti-rotating intramedullary nail', 'Tranexamic acid', 'tranexamic acid', 'TXA', 'perioperative tranexamic acid', 'tranexamic acid dissolved in 100 mL of saline (TXA group) or 100 mL of saline solution (placebo']","['hidden blood loss', 'obvious blood loss', 'Perioperative blood loss, obvious blood loss, and hidden blood loss', 'blood loss and transfusion rate', 'blood loss: perioperative blood loss', 'shorter hospital stays', 'Efficacy and safety', 'blood transfusion', 'efficacy and safety', 'perioperative blood loss and blood transfusion rate', 'Vascular events and patient mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C4521688', 'cui_str': 'Dissolve (transformation)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",176.0,0.172318,"CONCLUSION


Tranexamic acid significantly lowered perioperative blood loss and blood transfusion rate without an increased risk of venous thromboembolism or mortality in elderly patients with trochanteric fractures treated with dynamic hip screw or proximal anti-rotating intramedullary nail.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,['10.12809/hkmj187570']
887,31711874,A pilot study to examine the acceptability and health effects of electronic cigarettes in HIV-positive smokers.,"INTRODUCTION


Some HIV-positive smokers report ambivalence about quitting. Switching to electronic cigarettes (ECs) may be a viable option to reduce the negative health effects for smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs). This study examined the acceptability and health-related effects of ECs in HIV-positive smokers who were not seeking smoking cessation treatment.
METHODS


HIV-positive smokers (N = 19) were enrolled and followed for 12 weeks. Cartridge-based ECs were provided at baseline, and E-liquid was provided weekly for 8 weeks. At baseline, weeks 1-8, and week 12, EC and CC use, cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels were measured.
RESULTS


At week 8, cigarettes per day (CPD) were reduced by more than 80%, with reduction maintained at week 12 (p's < .001). Cigarette dependence scores were 40% lower at week 8 than at baseline (p <  .001). Seven (36.8%) participants reported transitioning completely from CCs to ECs. Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001). Intention to quit increased significantly over time.
CONCLUSIONS


Switching from CCs to ECs in HIV-positive smokers who are not ready to quit smoking in the next 30 days appears to be feasible. Beneficial effects were seen, such as reduced CPD, reduced CO and CC dependence, and increased motivation to quit. ECs may be promising as a harm reduction approach among HIV-positive smokers who are unable or unwilling to quit smoking.",2020,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001).,"['smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs', 'HIV-positive smokers who were not seeking smoking cessation treatment', 'HIV-positive smokers (N\u202f=\u202f19) were enrolled and followed for 12 weeks', 'HIV-positive smokers', 'HIV-positive smokers who are unable or unwilling to quit smoking']","['electronic cigarettes (ECs', 'electronic cigarettes', 'ECs']","['Cigarette dependence scores', 'Beneficial effects', 'reduced CPD, reduced CO and CC dependence, and increased motivation to quit', 'cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels', 'Mean CO', 'acceptability and health effects', 'Intention to quit increased significantly over time']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0650687,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA. Electronic address: Patricia_Cioe@brown.edu.'}, {'ForeName': 'Alana N', 'Initials': 'AN', 'LastName': 'Mercurio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Costantino', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology and Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107678']
888,31757518,"Anticipation of monetary reward in amygdala, insula, caudate are predictors of pleasure sensitivity to d-Amphetamine administration.","BACKGROUND


Drug addiction and dependence continue as an unresolved source of morbidity and mortality. Two approaches to identifying risk for abuse and addiction are psychopharmacological challenge studies and neuroimaging experiments. The present study combined these two approaches by examining associations between self-reported euphoria or liking after a dose of d-amphetamine and neural-based responses to anticipation of a monetary reward.
METHODS


Healthy young adults (N = 73) aged 19 and 26, without any history of alcohol/substance dependence completed four laboratory sessions in which they received oral d-amphetamine (20 mg) or placebo, and completed drug effect questionnaires. On a separate session they underwent a functional magnetic resonance imaging scan while they completed a monetary incentive delay task. During the task, we recorded neural signal related to anticipation of winning $5 or $1.50 compared to winning no money (WinMoney-WinZero), in reward related regions.
RESULTS


Liking of amphetamine during the drug sessions was related to differences in activation during the WinMoney-WinZero conditions - in the amygdala (positive), insula (negative) and caudate (negative). In posthoc analyses, liking of amphetamine was also positively correlated with activation of the amygdala during anticipation of large rewards and negatively related to activation of the left insula to both small and large anticipated rewards.
CONCLUSIONS


These findings suggest that individual differences in key regions of the reward network are related to rewarding subjective effects of a stimulant drug. To further clarify these relationships, future pharmacofMRI studies could probe the influence of amphetamine at the neural level during reward anticipation.",2020,"Liking of amphetamine during the drug sessions was related to differences in activation during the WinMoney-WinZero conditions - in the amygdala (positive), insula (negative) and caudate (negative).","['Healthy young adults (N\u202f=\u202f73) aged 19 and 26, without any history of alcohol/substance dependence completed four laboratory sessions in which they received']","['amphetamine', 'oral d-amphetamine (20\u202fmg) or placebo', 'functional magnetic resonance imaging scan']",['euphoria or liking'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0038580', 'cui_str': 'Substance Dependence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}]","[{'cui': 'C0235146', 'cui_str': 'Euphoria'}]",,0.0465593,"Liking of amphetamine during the drug sessions was related to differences in activation during the WinMoney-WinZero conditions - in the amygdala (positive), insula (negative) and caudate (negative).","[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 501 Chipeta Way, Salt Lake City, UT 84108, USA; Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor St, Chicago, IL 60612, USA. Electronic address: s.langenecker@hsc.utah.edu.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Kling', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor St, Chicago, IL 60612, USA.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor St, Chicago, IL 60612, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor St, Chicago, IL 60612, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nusslock', 'Affiliation': 'Department of Psychology, Northwestern University, Swift Hall 102, 2029 Sheridan Road, Evanston, IL 60208, USA.'}, {'ForeName': 'Katherine S F', 'Initials': 'KSF', 'LastName': 'Damme', 'Affiliation': 'Department of Psychology, Northwestern University, Swift Hall 102, 2029 Sheridan Road, Evanston, IL 60208, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Billings Hospital, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive Lexington, KY 40506-0044, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor St, Chicago, IL 60612, USA; Mental Health Service Line, Jesse Brown VA Medical Center, 820 S Damen Ave, Chicago, IL 60612, USA; Department of Psychiatry and Behavioral Health, The Ohio State University, OSU Harding Hospital, 1670 Upham Drive, Suite 130, Columbus, OH 43210, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107725']
889,30936290,Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment.,"OBJECTIVE


To investigate the distribution of whole-body magnetic resonance imaging (WB-MRI) inflammatory lesions of peripheral joints and entheses, and their response to adalimumab (ADA) treatment and agreement with clinical measures of disease activity in patients with axial spondyloarthritis (axSpA).
METHODS


Explorative analysis of an investigator-initiated randomized controlled trial of ADA. WB-MRI was performed at weeks 0, 6, 24, and 48. Detailed analyses of WB-MRI lesions in peripheral joints and entheses were performed, including agreement with clinical measures of disease activity.
RESULTS


WB-MRI inflammatory lesions were most frequently observed in the acromioclavicular, metatarsophalangeal, and wrist joints (> 10% of joints), and at the greater trochanter, calcaneal insertion of the Achilles tendon, and ischial tuberosity (> 15% of entheses). Inflammation resolved in ≥ 2/3 of involved sternoclavicular, metacarpophalangeal, first carpometacarpal, hip, and tarsometatarsal joints, and pubic symphyses and medial femoral condyles. In contrast, inflammation resolved in ≤ 1/6 of involved acromioclavicular joints, knee joints, and supraspinatus tendon insertions at humerus. Tenderness of joints and entheses agreed poorly with WB-MRI inflammation (κ < 0.40). Joint tenderness resolved more frequently in MRI-positive than MRI-negative joints (8/13, 62% vs 9/34, 26%) after 6 weeks of active treatment.
CONCLUSION


Inflammatory lesions of peripheral joints and entheses in patients with predominantly axSpA, and changes therein, can be mapped using WB-MRI, and it may contribute to differentiate between inflammatory and noninflammatory joint tenderness. (Trial registration: ClinicalTrials NCT01029847).",2020,Tenderness of joints and entheses agreed poorly with whole-body MRI inflammation (kappas <0.40).,"['patients with axial spondyloarthritis', 'patients with predominantly axial spondyloarthritis']",['adalimumab'],"['Joint tenderness', 'WBMRI inflammatory lesions', 'trochanter, calcaneal insertion of the Achilles tendon, and ischial tuberosity', 'WBMRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0240094', 'cui_str': 'Joint tender'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C0223656', 'cui_str': 'Ischial tuberosity structure'}]",,0.04136,Tenderness of joints and entheses agreed poorly with whole-body MRI inflammation (kappas <0.40).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Krabbe', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. simonkrabbe@gmail.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Eshed', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Inge Juul', 'Initials': 'IJ', 'LastName': 'Sørensen', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Jensen', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jakob M', 'Initials': 'JM', 'LastName': 'Møller', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Balding', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ole Rintek', 'Initials': 'OR', 'LastName': 'Madsen', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Susanne Juhl', 'Initials': 'SJ', 'LastName': 'Pedersen', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Herlev and Gentofte Hospital, Herlev; Center for Rheumatology and Spine Diseases, and Gentofte Hospital, Hellerup, Denmark; Department of Diagnostic Imaging, Sheba Medical Center, affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",The Journal of rheumatology,['10.3899/jrheum.181159']
890,31714253,Cost Per Participant Recruited From Rural and Remote Areas Into a Smoking Cessation Trial Via Online or Traditional Strategies: Observational Study.,"BACKGROUND


Rural and remote residents are more likely to smoke than those who live in major cities; however, recruitment of research participants from rural and remote areas can be challenging. The cost per participant recruited from rural and remote areas via online (eg, social media) and traditional strategies (eg, print) has implications for researchers on how to allocate resources to maximize the number of participants recruited. Participant characteristics such as demographics, financial stress, mental health, and smoking-related factors may be associated with recruitment method (ie, online vs traditional), and so it is important to understand whether certain subgroups are more likely to be recruited via a particular strategy.
OBJECTIVE


This study aimed to determine the cost per participant recruited and examine whether characteristics such as demographics, financial stress, mental health, and smoking-related factors may be associated with the recruitment method (ie, online vs traditional).
METHODS


Participants were recruited into a randomized trial that provided smoking cessation support. Eligible participants were aged 18 years or older; used tobacco daily; had access to video communication software, internet, and telephone; had an email address; and lived in a rural or remote area of New South Wales, Australia. This study describes the natural (observed) experience of recruiting participants via online and traditional methods into a smoking cessation trial.
RESULTS


Over 17 months, 655 participants were recruited into the smoking cessation trial. A total of 88.7% (581/655) of the participants were recruited via online methods. Moreover, 1.8% (12/655) of the participants were recruited from remote locations and none from very remote areas. The cost per participant recruited by the various online strategies ranged from Aus $7.29 (US $4.96, £4.09, and €4.43) for Gumtree, a local online classified website, to Aus $128.67 (US $87.63, £72.20, and €78.28) for email. The cost per participant recruited using traditional strategies ranged from Aus $0 (US $0, £0, and €0) for word of mouth to Aus $3990.84 (US $2757.67, £2227.85, and €2477.11) for telephone. Women had greater odds of being recruited via online methods than men (odds ratio 2.50, 95% CI 1.42-4.40). No other characteristics were associated with the recruitment method.
CONCLUSIONS


The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies. Women have greater odds of being recruited via online strategies into rural smoking cessation trials.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000514303; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372584&isReview=true.",2019,"The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies.","['Participants', 'Eligible participants were aged 18 years or older; used tobacco daily; had access to video communication software, internet, and telephone; had an email address; and lived in a rural or remote area of New South Wales, Australia', 'Rural and remote residents', '655 participants were recruited into the smoking cessation trial', 'Cost Per Participant Recruited From Rural and Remote Areas Into a Smoking Cessation Trial']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",[],[],655.0,0.119921,"The cost per participant recruited via online and traditional strategies varied, with the range being smaller for online than traditional recruitment strategies.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, Australia.'}]",Journal of medical Internet research,['10.2196/14911']
891,30941442,Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to evaluate the effectiveness of perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program in pregnant women above the age of 35 years to prevent perineal tear and episiotomy.
METHODS


A randomized parallel assignment study involved two groups of pregnant women at the obstetrics outpatient clinic 4 weeks prior to their due date. The first group (n = 200) was educated to do digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program. The second group (n = 200) received only the prevention education program. Occurrence of perineal laceration was reported at time of delivery as a primary outcome. Statistical analysis was done using the IBM SPSS computer program (Statistical Package for the Social Sciences; IBM Corp, Armonk, NY, USA), release 22 for Microsoft Windows.
RESULTS


Delivery was significantly less complicated by perineal tear, episiotomy and postnatal pain in the first than in the second group (p < 0.05). Grades of perineal tear were mostly of first and second degree in the first group compared with the second group. We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
CONCLUSIONS


Performing antenatal digital perineal massage and PFMT in addition to health education is recommended to reduce perineal complications.",2020,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","['pregnant women above the age of 35 years to prevent perineal tear and episiotomy', 'two groups of pregnant women at the obstetrics outpatient clinic 4\xa0weeks prior to their due date', 'pregnant women older than 35\xa0years']","['prevention education program', 'perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program', 'digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program', 'Perineal massage and training reduce perineal trauma']","['Grades of perineal tear', 'Occurrence of perineal laceration', 'perineal tear, episiotomy and postnatal pain', 'hospital stay']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0341226,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","[{'ForeName': 'Amira S', 'Initials': 'AS', 'LastName': 'Dieb', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt. amirasaied2026@gmail.com.'}, {'ForeName': 'Amira Y', 'Initials': 'AY', 'LastName': 'Shoab', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Gabr', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdallah', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Shaban', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Attia', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}]",International urogynecology journal,['10.1007/s00192-019-03937-6']
892,30927509,Therapeutic Alliance Between Physical Therapists and Patients With Knee Osteoarthritis Consulting Via Telephone: A Longitudinal Study.,"OBJECTIVE


To explore therapeutic alliance between physical therapists and patients with knee osteoarthritis during telephone consultations. Specifically, to describe and compare physical therapist and patient ratings, to determine whether alliance changes over time, and to evaluate whether individual characteristics are associated with alliance.
METHODS


We performed a secondary analysis of 84 patients in the intervention arm of a randomized controlled trial who completed 5-10 consultations with 1 of 8 physical therapists via telephone over 26 weeks, involving education, advice, and prescription of a strengthening and physical activity program. Therapeutic alliance was measured after the second (week 4) and final consultations (week 26), using the Working Alliance Inventory-Short Form.
RESULTS


Patient and physical therapist ratings of the alliance were high. At week 4, patients rated the overall alliance, and all 3 subscales, higher than therapists. At 26 weeks, patients rated the Task subscale higher than therapists. Patient ratings for the Goal subscale decreased over time, while physical therapist ratings for total alliance and the Bond subscale increased. For patients, the variables of living with others, consulting with a therapist with no previous experience delivering care remotely, having more telephone consultations, and having a higher self-efficacy were associated with greater alliance ratings. Therapists were more likely to perceive a stronger alliance if they had less clinical experience and when treating patients who were younger and had higher self-efficacy.
CONCLUSION


Physical therapist perceptions of the therapeutic alliance tended to be lower than those of patients early in treatment, but differences were small and of unclear clinical significance. Some subgroups of patients rated the alliance more strongly than others.",2020,"Therapeutic alliance was measured after the second (week 4) and final consultations (week 26) using the Working Alliance Inventory (Short Form).
","['physiotherapists and patients with knee osteoarthritis consulting via', 'Secondary analysis of 84 patients in the intervention arm of a randomised controlled trial who completed 5-10 consultations with one of 8', 'physiotherapists and patients with knee osteoarthritis during telephone consultations']","['physiotherapists via telephone over 26 weeks, involving education, advice, and prescription of a strengthening and physical activity program', 'telephone']","['physiotherapist ratings for total alliance and ""bond"" sub-scale', 'Therapeutic alliance']","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0222045'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}]",84.0,0.0517591,"Therapeutic alliance was measured after the second (week 4) and final consultations (week 26) using the Working Alliance Inventory (Short Form).
","[{'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Lawford', 'Affiliation': 'University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Penny K', 'Initials': 'PK', 'LastName': 'Campbell', 'Affiliation': 'University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'University of Melbourne, Parkville, Victoria, Australia.'}]",Arthritis care & research,['10.1002/acr.23890']
893,30957508,Changes in Self-Reported Health and Psychosocial Outcomes in Older Adults Enrolled in Sedentary Behavior Intervention Study.,"PURPOSE


To estimate changes in self-reported health and psychosocial factors associated with a 12-week sedentary behavior intervention for older adults.
DESIGN


Exploratory secondary analysis of pilot randomized controlled trial.
SETTING


Kaiser Permanente Washington.
SUBJECTS


Sixty adults aged 60 to 89 with body mass index ≥30 kg/m 2 .
INTERVENTION


Participants were randomized to the I-STAND intervention or control group. I-STAND involved 6 coaching sessions, a study workbook, Jawbone UP activity tracker to prompt breaks from sitting, and activPAL feedback on objective sitting time.
MEASURES


At baseline and 12-week follow-up, participants completed a survey with validated measures of self-reported health outcomes (depression, stress, memory/concentration, sleep, pain, ability to do daily activities, energy, and quality of life) and modified scales measuring psychosocial factors (perceived benefits/barriers, social support, self-efficacy, and sedentary habit strength) regarding sedentary behavior.
ANALYSIS


Generalized linear models assessed associations between group assignment and change in each self-reported health and psychosocial score, adjusting for baseline scores.
RESULTS


I-STAND participants demonstrated improvements in self-efficacy (β = 0.35, 95% confidence interval [CI]: 0.10 to 0.60) and reduced habit strength (β= -0.23, 95% CI: -0.42 to -0.04) compared to control participants. There were no significant differences in self-reported health outcomes, although power was limited in this exploratory analysis.
CONCLUSION


A sedentary behavior reduction intervention for older adults resulted in improvements for some psychosocial factors. Health outcomes may require longer than 12 weeks to observe improvements.",2019,"RESULTS


I-STAND participants demonstrated improvements in self-efficacy (β = 0.35, 95% confidence interval [CI]: 0.10 to 0.60) and reduced habit strength (β= -0.23, 95% CI: -0.42 to -0.04) compared to control participants.","['Kaiser Permanente Washington', 'older adults', 'Sixty adults aged 60 to 89 with body mass index ≥30 kg/m 2 ', 'Older Adults Enrolled in Sedentary Behavior Intervention Study']","['Jawbone UP activity tracker to prompt breaks from sitting, and activPAL feedback', 'sedentary behavior intervention', 'sedentary behavior reduction intervention']","['reduced habit strength', 'Changes in Self-Reported Health and Psychosocial Outcomes', 'self-reported health outcomes', 'health outcomes (depression, stress, memory/concentration, sleep, pain, ability to do daily activities, energy, and quality of life) and modified scales measuring psychosocial factors (perceived benefits/barriers, social support, self-efficacy, and sedentary habit strength) regarding sedentary behavior', 'self-efficacy', 'health and psychosocial score']","[{'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0322945,"RESULTS


I-STAND participants demonstrated improvements in self-efficacy (β = 0.35, 95% confidence interval [CI]: 0.10 to 0.60) and reduced habit strength (β= -0.23, 95% CI: -0.42 to -0.04) compared to control participants.","[{'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Matson', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Anne D', 'Initials': 'AD', 'LastName': 'Renz', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Mikael Anne', 'Initials': 'MA', 'LastName': 'Greenwood-Hickman', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': '1 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117119841405']
894,31713266,"Innovative 1064-nm Nd:YAG Laser Significantly Improves Keratosis Pilaris, A Randomized, Double-Blind, Sham-Irradiation-Controlled Trial.","BACKGROUND AND OBJECTIVE


Keratosis pilaris (KP) is a common follicular disorder for which various topical agents and energy-based devices have been used with some efficacy. To evaluate the efficacy of a novel 1064-nm Nd:YAG laser for the reduction of skin roughness, erythema, and hyperpigmentation in KP subjects.
STUDY DESIGN/MATERIALS AND METHODS


Twenty-three subjects with untreated KP on the upper outer arms participated in a randomized, single-blind fashion. One arm of each subject was divided into upper and lower parts. One part was randomized to be treated with an innovative 1064-nm Nd:YAG laser, while the other part received sham irradiation. Subjects received four consecutive treatments at 4-week intervals. Antera3D was used to measure skin roughness, erythema, and hyperpigmentation at baseline and 4 weeks after the last treatment. Moreover, clinical outcomes were also evaluated by subjects' Global Improvement Score (GIS) and subjects' satisfaction grading scores.
RESULTS


Twenty-three subjects completed the study. There was statistically significant reduction of skin roughness measured by Antera3D compared with control group (P < 0.001). There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all). Subjects' satisfaction scores were graded significantly better in treatment parts (P < 0.001). No adverse events including burning, bulla, erosion, post-inflammatory hyper/hypopigmentation, and scar formation developed in any subjects throughout the study period.
CONCLUSION


This innovative 1064-nm Nd:YAG laser has proved to significantly and safely reduce skin roughness in Thai KP subjects compared with control after four sessions. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all).","['Keratosis pilaris (KP', 'Twenty-three subjects with untreated KP on the upper outer arms participated', '2019', 'Thai KP subjects', 'Twenty-three subjects completed the study']","['innovative 1064-nm Nd:YAG laser, while the other part received sham irradiation', 'novel 1064-nm Nd:YAG laser', 'Innovative 1064-nm Nd:YAG Laser']","[""skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score"", 'skin roughness, erythema, and hyperpigmentation', 'adverse events including burning, bulla, erosion, post-inflammatory hyper/hypopigmentation, and scar formation', ""Subjects' satisfaction scores"", ""subjects' Global Improvement Score (GIS) and subjects' satisfaction grading scores"", 'skin roughness']","[{'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005758', 'cui_str': 'Vesication'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0162835', 'cui_str': 'Hypomelanosis'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0402668,"There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all).","[{'ForeName': 'Praewvanid', 'Initials': 'P', 'LastName': 'Maitriwong', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Natsinee', 'Initials': 'N', 'LastName': 'Tangkijngamvong', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23184']
895,31713310,Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial.,"OBJECTIVE


The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year.
BACKGROUND


SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
METHODS


The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates.
RESULTS


Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis.
CONCLUSIONS


Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).",2020,"Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
","['patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy', '312 patients enrolled and treated, 264 were eligible per protocol and evaluable for', 'patients at high risk for endarterectomy']","['novel mesh-covered stent', 'GORE® Carotid Stent (GCS']","['low rates of death/stroke/myocardial infarction', 'rate of DSMI', 'major adverse events', 'KM estimates of 1-year event probability', 'freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis', 'Kaplan-Meier (KM) estimates', 'proportion with ipsilateral stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C1322797', 'cui_str': 'Covered Stent'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}]",264.0,0.344714,"Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population.
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, SUNY University at Buffalo & Kaleida Health, Buffalo, New York.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Bacharach', 'Affiliation': 'North Central Heart Institute, Sioux Falls, South Dakota.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Wellmont CVA Heart and Vascular Institute, Kingsport, Tennessee.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Randall', 'Affiliation': 'W.L. Gore & Associates, Inc., Flagstaff, Arizona.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Siddiqui', 'Affiliation': 'Jacobs Institute, SUNY University at Buffalo & Kaleida Health, Buffalo, New York.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Schonholz', 'Affiliation': 'Division of Vascular & Interventional Radiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Alani', 'Affiliation': 'Covenant Healthcare System, Saginaw, Michigan.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': 'Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28586']
896,29546692,Vitamin D supplementation does not prevent the testosterone decline in males with advanced heart failure: the EVITA trial.,"PURPOSE


Observational studies indicate a positive association between circulating 25-hydroxyvitamin D (25OHD) and testosterone (T) concentrations. Because low 25OHD concentrations and T deficiency are considered to be a generalized phenomenon in patients with advanced heart failure (HF), we aimed to investigate whether vitamin D supplementation has beneficial effects on T indices in these patients.
METHODS


In a pre-specified secondary analysis of the EVITA (effect of vitamin D on mortality in heart failure) randomized controlled trial, we analyzed in male subjects with 25OHD concentrations < 75 nmol/L the effect of a daily vitamin D 3  supplement of 4000 IU for 3 years (n = 71) vs. placebo (n = 62) on total T (TT), sex hormone-binding globulin (SHBG), free T (fT), and bioactive T (BAT). We assessed changes from baseline until study termination and between-group differences at study termination.
RESULTS


25OHD increased in the placebo group from 36.6 nmol/L by 9.2 nmol/L (95% CI 3.2-15.1 nmol/L; P = 0.003) and in the vitamin D group from 36.5 nmol/L by 63.9 nmol/L (95% CI 52.6-75.3 nmol/L; P < 0.001), with a significant between-group difference at study termination (P < 0.001). TT and SHBG concentrations did not change significantly, neither in the placebo group nor in the vitamin D group (P = 0.845-0.082), but concentrations of fT and BAT declined significantly in both groups (P = 0.025-0.008). At study termination, there were no between-group differences in TT (P = 0.612), SHBG (P = 0.393), fT (P = 0.861), or BAT (P = 0.960).
CONCLUSIONS


In male patients with advanced HF and low 25OHD concentrations, a daily vitamin D 3  supplement of 4000 IU for 3 years did not prevent the decline in testosterone indices.",2019,"TT and SHBG concentrations did not change significantly, neither in the placebo group nor in the vitamin D group (P = 0.845-0.082), but concentrations of fT and BAT declined significantly in both groups (P = 0.025-0.008).","['males with advanced heart failure', 'patients with advanced heart failure (HF', 'male subjects with 25OHD concentrations\u2009<\u200975\xa0nmol/L the effect of a', 'male patients with advanced HF and low 25OHD concentrations']","['vitamin D', 'vitamin D supplementation', 'placebo', 'Vitamin D supplementation', 'daily vitamin D 3  supplement of 4000\xa0IU for 3\xa0years (n\u2009=\u200971) vs. placebo']","['SHBG', '25OHD', 'testosterone decline', 'concentrations of fT and BAT', 'testosterone indices', 'total T (TT), sex hormone-binding globulin (SHBG), free T (fT), and bioactive T (BAT', 'TT and SHBG concentrations', 'circulating 25-hydroxyvitamin D (25OHD) and testosterone (T) concentrations']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008139', 'cui_str': 'Bats'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.58248,"TT and SHBG concentrations did not change significantly, neither in the placebo group nor in the vitamin D group (P = 0.845-0.082), but concentrations of fT and BAT declined significantly in both groups (P = 0.025-0.008).","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zittermann', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany. azittermann@hdz-nrw.de.'}, {'ForeName': 'Jana B', 'Initials': 'JB', 'LastName': 'Ernst', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Sylvana', 'Initials': 'S', 'LastName': 'Prokop', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Fuchs', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreier', 'Affiliation': 'Institute for Laboratory and Transfusion Medicine, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Institute for Laboratory and Transfusion Medicine, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Knabbe', 'Affiliation': 'Institute for Laboratory and Transfusion Medicine, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Heiner K', 'Initials': 'HK', 'LastName': 'Berthold', 'Affiliation': 'Department of Internal Medicine and Geriatrics, Bethel Clinic (EvKB), Bielefeld, Germany.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'Polyclinic for Endocrinology, Diabetes and Preventive Medicine (PEDP), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Gummert', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Börgermann', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pilz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",European journal of nutrition,['10.1007/s00394-018-1666-5']
897,29589119,Dairy products intake and the risk of incident cataracts surgery in an elderly Mediterranean population: results from the PREDIMED study.,"PROPOSAL


The aim of this study was to examine the association between the consumption of total and specific types of dairy products and the risk of incident cataracts in an elderly Mediterranean population at high cardiovascular risk.
METHODS


We prospectively analyzed 5860 subjects from the PREvención con DIeta MEDiterránea (PREDIMED) Study. The time to cataract surgery was calculated as the time between recruitment and the date of the surgery, last visit of the follow-up, date of death, or until the end of the study. Dairy products intake was assessed using validated food frequency questionnaires. We used Cox proportional hazard regression to assess the risk of cataract surgery according to average dietary energy-adjusted total dairy products, milk, yogurt and cheese consumption.
RESULTS


We documented a total of 768 new cataract events after a median of 5.6 years of follow-up. Subjects in the second [hazard ratio (HR) 0.62; 95% CI 0.52, 0.74] and third tertile (HR: 0.71; 95% CI 0.60, 0.85) of skimmed yogurt intake had a significantly lower risk of cataracts after adjusting for potential confounders. No significant associations were observed for total dairy products, whole and skimmed milk, whole yogurt and cheese consumption.
CONCLUSION


The intake of skimmed yogurt was associated with a reduced risk of cataracts in an elderly Mediterranean population with high cardiovascular risk. No significant associations were observed for other type of dairy product.
CLINICAL TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005.",2019,The intake of skimmed yogurt was associated with a reduced risk of cataracts in an elderly Mediterranean population with high cardiovascular risk.,"['elderly Mediterranean population with high cardiovascular risk', '768 new cataract events after a median of 5.6\xa0years of follow-up', '5860 subjects from the PREvención con DIeta MEDiterránea (PREDIMED) Study', 'elderly Mediterranean population', 'elderly Mediterranean population at high cardiovascular risk']",[],"['total dairy products, whole and skimmed milk, whole yogurt and cheese consumption', 'risk of cataracts', 'time to cataract surgery']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]",,0.108776,The intake of skimmed yogurt was associated with a reduced risk of cataracts in an elderly Mediterranean population with high cardiovascular risk.,"[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Camacho-Barcia', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, University Hospital of Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, St/Sant Llorenç 21, 43201, Reus, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, University Hospital of Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, St/Sant Llorenç 21, 43201, Reus, Spain. monica.bullo@urv.cat.'}, {'ForeName': 'Jesús F', 'Initials': 'JF', 'LastName': 'García-Gavilán', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, University Hospital of Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, St/Sant Llorenç 21, 43201, Reus, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, University Hospital of Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, St/Sant Llorenç 21, 43201, Reus, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Muñoz', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Zanon-Moreno', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'García-Layana', 'Affiliation': 'CIBERobn Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, University Hospital of Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, St/Sant Llorenç 21, 43201, Reus, Spain. jordi.salas@urv.cat.'}]",European journal of nutrition,['10.1007/s00394-018-1647-8']
898,31622769,The Systemic Metabolic Profile Early after Allogeneic Stem Cell Transplantation: Effects of Adequate Energy Support Administered through Enteral Feeding Tube.,"Patients undergoing allogeneic stem cell transplantation usually require nutritional support. There is no consensus on whether enteral support through tube feeding should be preferred. A recent randomized study could not detect any difference between enteral and parenteral feeding with regard to post-transplant outcomes, whereas 2 retrospective studies described an association between enteral feeding and a favorable post-transplant outcome. We compared pre- and post-transplant plasma metabolomic profiles for 10 patients receiving mainly enteral nutritional support and 10 patients receiving mainly parenteral support. Samples were collected before conditioning and 3 weeks post-transplant; 824 metabolites were analyzed using mass spectrometry. The pretransplant metabolite profiles showed a significant overlap between the 2 groups. Post-transplant samples for both patient groups showed an increase of secondary bile acids and endocannabinoids, whereas reduced levels were seen for food preservatives, plasmalogens, and retinol metabolites. The main post-transplant differences between the groups were decreased levels of fatty acids and markers of mitochondrial activation in the control group, indicating that these patients had insufficient energy intake. A significant effect was also seen for heme/bilirubin metabolism for the parenteral support. To conclude, allotransplant recipients showed altered metabolic profiles early after transplantation; this was mainly due to the conditioning/transplantation/reconstitution, whereas the type of nutritional support had minor effects.",2020,"Post-transplant samples for both patient groups showed an increase of secondary bile acids and endocannabinoids, whereas reduced levels were seen for food preservatives, plasmalogens and retinol metabolites.","['10 patients receiving mainly enteral nutritional support and 10 patients receiving mainly parenteral support', 'Patients undergoing allogeneic stem cell transplantation usually require nutritional support']",[],"['levels of fatty-acids and markers of mitochondrial activation', 'heme/ bilirubin metabolism', 'secondary bile acids and endocannabinoids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}]",824.0,0.0220178,"Post-transplant samples for both patient groups showed an increase of secondary bile acids and endocannabinoids, whereas reduced levels were seen for food preservatives, plasmalogens and retinol metabolites.","[{'ForeName': 'Tor Henrik Anderson', 'Initials': 'THA', 'LastName': 'Tvedt', 'Affiliation': 'Section for Hematology, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Section for Hematology, Institute of Clinical Science, University of Bergen, Bergen, Norway. Electronic address: thetve@helse-bergen.no.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Hematology, University of Oslo, Oslo; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geir Erland', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Hematology, University of Oslo, Oslo; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gedde-Dahl', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Hematology, University of Oslo, Oslo; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Norway; Division of Human Nutrition, Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Bruserud', 'Affiliation': 'Section for Hematology, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Section for Hematology, Institute of Clinical Science, University of Bergen, Bergen, Norway.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.10.005']
899,30906977,[Long-term individual cognitive stimulation program in patients with mild neurocognitive disorder: a pilot study].,"INTRODUCTION


There is evidence to suggest that cognitive stimulation produces cognitive benefits in people with mild neurocognitive disorder. However, the effect has been previously demonstrated to be minimal to moderate and the effect of long-term individual interventions, namely on specific cognitive domains, is unknown.
AIM


To assess the efficacy, feasibility and acceptability of a long-term individual cognitive stimulation intervention for patients with mild neurocognitive disorder.
PATIENTS AND METHODS


Patients (n = 30) with mild neurocognitive disorder were assigned to a cognitive stimulation intervention group (n = 15) or to a control group (n = 15). The intervention consisted of 88 individual sessions, approximately 45 minutes long, with two sessions per week. External evaluators assessed the level of alteration in cognitive performance, depressive symptoms and the level of independence in the performance of basic activities of daily living.
RESULTS


After the intervention, a significant improvement was found in the intervention group compared to the control group in overall cognitive performance (d = 0.83), specifically in the language domain (d until 1.50). There were also lower depressive symptoms in the intervention group compared to the control group (d = 0.93). Only 6.7% of the participants dropped out the study, with participants attending a mean of 83 ± 12.1 sessions.
CONCLUSIONS


The results support the efficacy, feasibility and acceptability of the intervention for mild neurocognitive disorder and justify a randomized controlled trial of the program with a larger sample.",2019,"After the intervention, a significant improvement was found in the intervention group compared to the control group in overall cognitive performance (d = 0.83), specifically in the language domain (d until 1.50).","['Patients (n = 30) with mild neurocognitive disorder', 'patients with mild neurocognitive disorder', 'people with mild neurocognitive disorder', 'mild neurocognitive disorder']","['cognitive stimulation intervention', 'Long-term individual cognitive stimulation program', 'long-term individual cognitive stimulation intervention', 'cognitive stimulation']","['overall cognitive performance', 'depressive symptoms', 'level of alteration in cognitive performance, depressive symptoms and the level of independence in the performance of basic activities of daily living', 'efficacy, feasibility and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living (observable entity)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0806845,"After the intervention, a significant improvement was found in the intervention group compared to the control group in overall cognitive performance (d = 0.83), specifically in the language domain (d until 1.50).","[{'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Justo-Henriques', 'Affiliation': 'Cediara - Associacao de Solidariedade Social de Ribeira de Fraguas, Aveiro, Portugal.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Marques-Castro', 'Affiliation': 'Cediara - Associacao de Solidariedade Social de Ribeira de Fraguas, Aveiro, Portugal.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Universidad de A Coruna, A Coruna, Espana.'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Vazquez', 'Affiliation': 'Universidad de Santiago de Compostela, Santiago de Compostela, Espana.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': 'Universidad de Santiago de Compostela, Santiago de Compostela, Espana.'}]",Revista de neurologia,['10.33588/rn.6807.2018321']
900,29602956,Effects of vitamin D supplementation on FGF23: a randomized-controlled trial.,"PURPOSE


Fibroblast growth factor-23 (FGF23) is critical for phosphate homeostasis. Considering the high prevalence of vitamin D deficiency and the association of FGF23 with adverse outcomes, we investigated effects of vitamin D3 supplementation on FGF23 concentrations.
METHODS


This is a post-hoc analysis of the Styrian Vitamin D Hypertension trial, a single-center, double-blind, randomized, placebo-controlled trial, conducted from 2011 to 2014 at the Medical University of Graz, Austria. Two hundred subjects with 25(OH)D concentrations < 30 ng/mL and arterial hypertension were randomized to receive either 2800 IU of vitamin D3 daily or placebo over 8 weeks. Primary outcome was the between-group difference in FGF23 levels at study end while adjusting for baseline values.
RESULTS


Overall, 181 participants (mean ± standard deviation age, 60.1 ± 11.3; 48% women) with available c-term FGF23 concentrations were considered for the present analysis. Mean treatment duration was 54 ± 10 days in the vitamin D3 group and 54 ± 9 days in the placebo group. At baseline, FGF23 was significantly correlated with serum phosphate (r = 0.135; p = 0.002). Vitamin D3 supplementation had no significant effect on FGF23 in the entire cohort (mean treatment effect 0.374 pmol/L; 95% confidence interval - 0.024 to 0.772 pmol/L; p = 0.065), but increased FGF23 concentrations in subgroups with baseline 25(OH)D concentrations below 20 ng/mL (n = 70; mean treatment effect 0.973 pmol/L; 95% confidence interval - 0.032 to 1.979 pmol/L; p = 0.019) and 16 ng/mL (n = 40; mean treatment effect 0.593 pmol/L; 95% confidence interval 0.076 to 1.109; p = 0.022).
CONCLUSIONS


Vitamin D3 supplementation had no significant effect on FGF23 in the entire study cohort. We did, however, observe an increase of FGF23 concentrations in subgroups with low baseline 25(OH)D.",2019,"Vitamin D3 supplementation had no significant effect on FGF23 in the entire cohort (mean treatment effect 0.374 pmol/L; 95% confidence interval - 0.024 to 0.772 pmol/L; p = 0.065), but increased FGF23 concentrations in subgroups with baseline 25(OH)D concentrations below 20 ","['Two hundred subjects with 25(OH)D concentrations\u2009<\u200930\xa0ng/mL and arterial hypertension', '181 participants (mean\u2009±\u2009standard deviation age, 60.1\u2009±\u200911.3; 48% women) with available c-term FGF23 concentrations', '2011 to 2014\xa0at the Medical University of Graz, Austria', 'subgroups with low baseline 25(OH)D']","['vitamin D supplementation', 'placebo', 'vitamin D3 daily or placebo', 'Vitamin D3 supplementation', 'vitamin D3 supplementation', 'vitamin D3']","['FGF23 concentrations', 'serum phosphate', 'FGF23 levels', 'FGF23']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.765831,"Vitamin D3 supplementation had no significant effect on FGF23 in the entire cohort (mean treatment effect 0.374 pmol/L; 95% confidence interval - 0.024 to 0.772 pmol/L; p = 0.065), but increased FGF23 concentrations in subgroups with baseline 25(OH)D concentrations below 20 ","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Trummer', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. christian.trummer@medunigraz.at.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Schwetz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Pandis', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Grübler', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Verheyen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gaksch', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University, Müllner Hauptstraße 48, 5020, Salzburg, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zittermann', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'März', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aberer', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steinkellner', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Friedl', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 27, 8036, Graz, Austria.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brandenburg', 'Affiliation': 'Department of Cardiology, University Hospital of the RWTH Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Voelkl', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Alesutan', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tomaschitz', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pilz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}]",European journal of nutrition,['10.1007/s00394-018-1672-7']
901,30868305,Role of Spreader Flaps in Rhinoplasty: Analysis of Patients Undergoing Correction for Severe Septal Deviation with Long-Term Follow-Up.,"INTRODUCTION


The aim of this randomized controlled study was to analyze the long-term results of patients undergoing rhinoplasty because of severe septal deviation and to evaluate the stability of results.
MATERIALS AND METHODS


The study was performed with a randomized design. Patients were randomly divided into four groups: group 1, spreader flaps were used in combination with spreader grafts; group 2, spreader flaps were used alone; group 3, spreader grafts were used alone; and group 4, neither spreader flaps nor grafts flaps were used. Patients answered the Italian version of the FACE-Q rhinoplasty module. Anthropometric measurements were performed by AutoCAD for MAC. We determined the angle of deviation, and we compared the pre- and postoperative angles and compared patient satisfaction in the four groups using the Chi-squared test for unpaired data. Two plastic surgeons reviewed all the postoperative photographs of the study patients and rated the photographs on a scale of 1 to 5.
RESULTS


A total of 264 patients who underwent primary rhinoplasty between January 2010 and September 2016 satisfied the inclusion criteria and were finally enrolled in this study. Anthropometric measurements revealed statistically significant differences (P < 0.01) between the preoperative and postoperative values for the angle of septal deviation in group 1 versus the other groups. Over the long-term follow-up, group 1 maintained an angle close to 180 degrees (P < 0.01). Group 1 and group 3 were more satisfied compared with groups 2 and 4 (P < 0.01). According to evaluations by the 2 reviewers, group 1 and group 3 were the most satisfactory outcomes (P < 0.01).
CONCLUSIONS


This was the first randomized study to show that the combined use of the spreader flap and spreader graft is the best choice for a good long-term outcome and durable correction of septal deviation.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,Group 1 and group 3 were more satisfied compared with groups 2 and 4 (P < 0.01).,"['Patients Undergoing Correction for Severe Septal Deviation with Long-Term Follow-Up', 'Spreader Flaps in Rhinoplasty', '264 patients who underwent primary rhinoplasty between January 2010 and September 2016 satisfied the inclusion criteria and were finally enrolled in this study', 'patients undergoing rhinoplasty because of severe septal deviation']","['IV', 'spreader flap and spreader graft', 'spreader flaps were used in combination with spreader grafts; group 2, spreader flaps were used alone; group 3, spreader grafts were used alone; and group 4, neither spreader flaps nor grafts flaps']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0183479', 'cui_str': 'Spreader (physical object)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0183479', 'cui_str': 'Spreader (physical object)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}]",[],264.0,0.0500869,Group 1 and group 3 were more satisfied compared with groups 2 and 4 (P < 0.01).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Colapietra', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alessandri Bonetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Morelli Coppola', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'List', 'Affiliation': 'Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01343-3']
902,31563660,"Does Creatine Supplementation Affect Renal Function in Patients with Peripheral Artery Disease? A Randomized, Double Blind, Placebo-controlled, Clinical Trial.","BACKGROUND


Case studies and reviews have shown that creatine supplementation can affect kidney function. The objective of this study is to verify the effects of 8 weeks of creatine supplementation on renal function (creatinine clearance: primary outcome) in patients with symptomatic peripheral arterial disease.
METHODS


Twenty-nine patients, of both genders, were randomized (1:1) in a double-blind manner for administration of Placebo (PLA; n = 15) or creatine monohydrate (Cr; n = 14). The supplementation protocol consisted of 20 g/day for 1 week divided into 4 equal doses (loading phase), followed by single daily doses of 5 g in the subsequent 7 weeks (maintenance phase). Before and after the supplementation period, markers of renal function, serum creatinine, creatinine excretion rate, and creatinine clearance were evaluated. The Generalized Estimation Equation Model was used for comparison between groups. The level of significance was P < 0.05.
RESULTS


No significant differences were found between groups before and after the intervention for serum creatinine (Cr: pre 1.00 ± 0.15 mL/dL vs. post 1.07 ± 0.16 mL/dL; PLA: pre 1.30 ± 0.53 mL/dL vs. post 1.36 ± 0.47 mL/dL, P = 0.590), creatinine excretion rate (Cr: pre 81.73 ± 43.80 mg/dL vs. post 102.92 ± 59.57 mg/dL; PLA: pre 74.37 ± 38.90 mg/dL vs. post 86.22 ± 39.94 mg/dL, P = 0.560), or creatinine clearance (Cr; pre 108 ± 59 mL/min/1.73 m 2  vs. post 117 ± 52 mL/min/1.73 m 2 ; PLA: pre 88 ± 49 mL/min/1.73 m 2  vs. post 82 ± 47 mL/min/1.73 m 2 , P = 0.366).
CONCLUSIONS


Eight weeks of creatine supplementation is safe and does not compromise the renal function of patients with peripheral arterial disease.",2020,"No significant differences were found between groups before and after the intervention for serum creatinine (Cr - pre 1.00 ± 0.15 ml/dl vs. post 1.07 ± 0.16 ml/dl; PLA pre 1.30 ± 0.53 ml/dl vs. post 1.36 ± 0.47 ml/dl, p = 0.590), creatinine excretion rate (Cr - pre 81.73 ± 43.80 mg/dl","['Twenty-nine patients, of both genders', 'patients with symptomatic peripheral arterial disease', 'patients with peripheral arterial disease', 'patients with peripheral artery disease']","['creatine supplementation', 'placebo', 'Placebo (PLA, n=15) or creatine monohydrate']","['creatinine excretion rate', 'renal function', 'renal function, serum creatinine, creatinine excretion rate, and creatinine clearance', 'renal function (creatinine clearance - primary outcome', 'serum creatinine', 'creatinine clearance']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0873188', 'cui_str': 'Creatine Monohydrate'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",117.0,0.513706,"No significant differences were found between groups before and after the intervention for serum creatinine (Cr - pre 1.00 ± 0.15 ml/dl vs. post 1.07 ± 0.16 ml/dl; PLA pre 1.30 ± 0.53 ml/dl vs. post 1.36 ± 0.47 ml/dl, p = 0.590), creatinine excretion rate (Cr - pre 81.73 ± 43.80 mg/dl","[{'ForeName': 'Wagner Jorge Ribeiro', 'Initials': 'WJR', 'LastName': 'Domingues', 'Affiliation': 'Federal University of Amazonas, Parintins, Brazil. Electronic address: wagnerfef@gmail.com.'}, {'ForeName': 'Raphael Mendes', 'Initials': 'RM', 'LastName': 'Ritti-Dias', 'Affiliation': 'Nove de Julho University, São Paulo, Brazil.'}, {'ForeName': 'Gabriel Grizzo', 'Initials': 'GG', 'LastName': 'Cucato', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'Hospital Israelita Albert Einstein, Sao Paulo Brazil.'}, {'ForeName': 'Antonio Eduardo', 'Initials': 'AE', 'LastName': 'Zerati', 'Affiliation': 'Cancer Institute of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Puech-Leão', 'Affiliation': 'Sao Paulo University, Sao Paulo, Brazil.'}, {'ForeName': 'Pollyana Mayara', 'Initials': 'PM', 'LastName': 'Nunhes', 'Affiliation': 'State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Andre Alberto', 'Initials': 'AA', 'LastName': 'Moliterno', 'Affiliation': 'State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Ademar', 'Initials': 'A', 'LastName': 'Avelar', 'Affiliation': 'State University of Maringa, Maringa, Brazil.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.07.008']
903,31708447,"A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial.","BACKGROUND


Patients with recent stroke or transient ischaemic attack are at high risk for a further vascular event, possibly leading to permanent disability or death. Although evidence-based treatments for secondary prevention are available, many patients do not achieve recommended behavioural modifications and pharmaceutical prevention targets in the long-term. We aimed to investigate whether a support programme for enhanced secondary prevention can reduce the frequency of recurrent vascular events.
METHODS


INSPiRE-TMS was an open-label, multicentre, international randomised controlled trial done at seven German hospitals with acute stroke units and a Danish stroke centre. Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included. Computerised randomisation was used to allocate patients (1:1) either to the support programme in addition to conventional care or to conventional care alone. The support programme used feedback and motivational interviewing strategies with eight outpatient visits over 2 years aiming to improve adherence to secondary prevention targets. The primary outcome was the composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population (all patients who underwent randomisation, did not withdraw study participation, and had at least one follow-up). Outcomes were assessed at annual follow-ups using time-to-first-event analysis. All-cause death was monitored as a safety outcome. This trial is registered with ClinicalTrials.gov, NCT01586702.
FINDINGS


From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients. Of those, 1048 (50·0%) were randomly assigned to the support programme group and 1050 (50·0%) patients were assigned to the conventional care group. 1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis. The mean age of analysed participants was 67·4 years and 700 (34%) were women. After a mean follow-up of 3·6 years, the primary outcome of major vascular events had occurred in 163 (15·8%) of 1030 patients of the support programme group and in 175 (16·8%) of 1042 patients of the conventional care group (hazard ratio [HR] 0·92, 95% CI 0·75-1·14). Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17). More patients in the support programme group achieved secondary prevention targets (eg, in 1-year-follow-up 52% vs 42% [p<0·0001] for blood pressure, 62% vs 54% [p=0·0010] for LDL, 33% vs 19% [p<0·0001] for physical activity, and 51% vs 34% [p=0·0010] for smoking cessation).
INTERPRETATION


Provision of an intensified secondary prevention programme in patients with non-disabling stroke or transient ischaemic attack was associated with improved achievement of secondary prevention targets but did not lead to a significantly lower rate of major vascular events. Further research is needed to investigate the effects of support programmes in selected patients who do not achieve secondary prevention targets soon after discharge.
FUNDING


German Federal Ministry of Education and Research, Pfizer, and German Stroke Foundation.",2020,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","['From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients', 'seven German hospitals with acute stroke units and a Danish stroke centre', '1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis', 'Patients with recent stroke or transient ischaemic attack', 'The mean age of analysed participants was 67·4 years and 700 (34%) were women', 'Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included', 'patients with transient ischaemic attack and minor stroke (INSPiRE-TMS', 'selected patients who do not achieve secondary prevention targets soon after discharge', 'patients with non-disabling stroke or transient ischaemic attack']","['support programme in addition to conventional care or to conventional care alone', 'conventional care group']","['major vascular events', 'blood pressure', 'secondary prevention targets', 'physical activity', 'composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population', 'cause death', 'Total major vascular event numbers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",2098.0,0.159218,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Laumeier', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ihl', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Steinicke', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ferse', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Centre for Cardiovascular Research, Berlin, Germany; German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Sidsel', 'Initials': 'S', 'LastName': 'Hastrup', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Palm', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schoene', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Seifert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Institute of Computational Neuroscience, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Weber', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'von Weitzel-Mudersbach', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Martin L J', 'Initials': 'MLJ', 'LastName': 'Wimmer', 'Affiliation': 'Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, Munich, Germany.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Jacoba P', 'Initials': 'JP', 'LastName': 'Greving', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Busse', 'Affiliation': 'German Stroke Society, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Köhler', 'Affiliation': 'Medical Department, Division of Cardiology and Angiology, Campus Charité Mitte, Centre for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marx', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Heinrich J', 'Initials': 'HJ', 'LastName': 'Audebert', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address: Heinrich.audebert@charite.de.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30369-2']
904,31707825,Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.,"BACKGROUND


Recent court decisions have thrown into question the Food and Drug Administration's rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians' beliefs about drug efficacy.
METHODS AND RESULTS


In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%,  P <0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]).
CONCLUSIONS


Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.",2019,"Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.","['686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose']",[],['cardiovascular risk'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3486026', 'cui_str': 'Vascepa'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",686.0,0.137453,"Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Schwartz', 'Affiliation': 'Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (L.M.S., S.W.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woloshin', 'Affiliation': 'Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (L.M.S., S.W.).'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'American Board of Internal Medicine, Philadelphia, PA (K.M.R.).'}, {'ForeName': 'Frazer A', 'Initials': 'FA', 'LastName': 'Tessema', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Peter', 'Affiliation': 'The Center for Outcomes Research & Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT (D.P.).'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Kesselheim', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006073']
905,31707826,Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial.,"BACKGROUND


In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18 924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES.
METHODS AND RESULTS


In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16 629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00];  P =0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007];  P =0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986];  P =0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13];  P =0.03).
CONCLUSIONS


Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths.",[],"['placebo', 'Alirocumab', 'alirocumab']","['Total Hospitalizations and Increases Days Alive and Out of Hospital', 'hazard functions for total hospitalizations and death', 'coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths', 'alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH', 'total hospitalizations', 'DAOH relative']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",331.0,0.262428,"Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY (M.S.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris University, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France (P.G.S.).'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'DiCenso', 'Affiliation': 'Woodhull Medical Center, Brooklyn, NY (D.D.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL (V.A.B.).'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St Michael's Hospital, University of Toronto, Ontario, Canada (S.G.G.).""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gotcheva', 'Affiliation': 'MHAT ""National Cardiology Hospital"" EAD, Sofia, Bulgaria (N.G.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, the Netherlands (J.W.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (R.P.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R.).'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Sourdille', 'Affiliation': 'Sanofi, Bridgewater, NJ (T.S.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand (H.D.W.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India (D.X.).""}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO (G.G.S.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005858']
906,31936256,Validation of Psychosocial Measures Assessing American Indian Parental Beliefs Related to Control over Their Children's Oral Health.,"OBJECTIVES


To validate questionnaire items assessing American Indian (AI) parental beliefs regarding control over their children's oral health within the context of psychosocial measures and children's oral health status.
METHODS


Baseline questionnaire data were collected as part of a randomized controlled trial ( n  = 1016) addressing early childhood caries. Participants were AI parents with preschool-age children in the Navajo Nation Head Start program. Questionnaire items assessed parental oral health locus of control (OHLOC) and agreement with beliefs indicating that they were in control of their children's oral health (internal), the dentist was in control (external powerful others), or children's oral health was a matter of chance (external chance). Exploratory factor analysis was conducted, and convergent validity was assessed using linear regression.
RESULTS


Parents with more education ( p  < 0.0001) and income ( p  = 0.001) had higher scores for internal OHLOC. Higher internal OHLOC scores were associated with higher scores on knowledge ( p  < 0.0001), perceived seriousness and benefits ( p  < 0.0001), higher self-efficacy, importance, sense of coherence ( p  < 0.0001 for all), and lower scores for perceived barriers ( p  < 0.0001) and distress ( p  = 0.01). Higher scores for both types of external OHLOC were associated with lower scores on knowledge ( p  < 0.0001), perceived seriousness ( p  < 0.0001), and higher scores on perceived susceptibility ( p  = 0.01 external chance; <0.0001 powerful others) and barriers (<0.0001). Higher scores for external powerful others were associated with lower scores for importance ( p  = 0.04) and sense of coherence ( p  = 0.03). Significant associations were not found for OHLOC beliefs and children's oral health status.
CONCLUSIONS


Questionnaire items addressing OHLOC functioned in accordance with the theoretical framework in AI participants.",2020,"Higher scores for both types of external OHLOC were associated with lower scores on knowledge ( p  < 0.0001), perceived seriousness ( p  < 0.0001), and higher scores on perceived susceptibility ( p  = 0.01 external chance; <0.0001 powerful others) and barriers (<0.0001).","['Participants were AI parents with preschool-age children in the Navajo Nation Head Start program', 'Baseline questionnaire data were collected as part of a randomized controlled trial ( n  = 1016) addressing early childhood caries']",[],"['higher self-efficacy, importance, sense of coherence', 'Higher internal OHLOC scores', 'Questionnaire items assessed parental oral health locus of control (OHLOC) and agreement with beliefs', 'distress', ""OHLOC beliefs and children's oral health status""]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600394', 'cui_str': 'Head Start Program'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178983', 'cui_str': 'Salutogeneses'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0029162'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",1016.0,0.039471,"Higher scores for both types of external OHLOC were associated with lower scores on knowledge ( p  < 0.0001), perceived seriousness ( p  < 0.0001), and higher scores on perceived susceptibility ( p  = 0.01 external chance; <0.0001 powerful others) and barriers (<0.0001).","[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 E. 16th Ave. B240, Aurora, CO 80045, USA.'}, {'ForeName': 'Tamanna', 'Initials': 'T', 'LastName': 'Tiwari', 'Affiliation': 'School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 E. 16th Ave. B240, Aurora, CO 80045, USA.'}, {'ForeName': 'Jacob F', 'Initials': 'JF', 'LastName': 'Thomas', 'Affiliation': 'Adult and Child Consortium of Outcomes Research and Dissemination Science University of Colorado, Anschutz Medical Campus, 13199 E. Montview Blvd., Suite 300 F443, Aurora, CO 80045, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Henderson', 'Affiliation': 'Adult and Child Consortium of Outcomes Research and Dissemination Science University of Colorado, Anschutz Medical Campus, 13199 E. Montview Blvd., Suite 300 F443, Aurora, CO 80045, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Braun', 'Affiliation': 'Adult and Child Consortium of Outcomes Research and Dissemination Science University of Colorado, Anschutz Medical Campus, 13199 E. Montview Blvd., Suite 300 F443, Aurora, CO 80045, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13199 E. Montview, Blvd, Suite 300, W359-G, Aurora, CO 80045, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17020403']
907,31887280,Comparison of Perioperative Parameters in Femtosecond Laser-Assisted Cataract Surgery Using 3 Nuclear Fragmentation Patterns.,"PURPOSE


The purpose of this study was to compare the perioperative parameters of quadrant, sextant, and grid lens fragmentation patterns in femtosecond laser-assisted cataract surgery (FLACS).
DESIGN


Prospective randomized clinical trial.
METHODS


Setting: Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
STUDY POPULATION


A total of 894 eyes in 661 patients with cataracts were enrolled. Intervention or observation procedures: the nuclear density was graded according to the Emery-Little classification. Patients received lens fragmentation using a quadrant, sextant, or grid pattern after random allocation. Evaluations included intraoperative parameters, complications, and postoperative outcomes.
MAIN OUTCOME MEASUREMENTS


effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure at one day postoperatively, as well as endothelial cell density, endothelial cell loss, and central corneal thickness at 1 week postoperatively.
RESULTS


In grade 1 nuclei, the mean EPT in the grid group was the shortest compared to those in the quadrant (P = 0.011) and sextant (P = 0.001) groups. In grade 2 nuclei, all 3 patterns showed no significant differences in the mean EPT (P > 0.05). In grade 3 nuclei, the sextant group revealed shorter mean EPT than the grid (P = 0.017) and quadrant (P > 0.05) groups. In grades 4 and 5 nuclei, the quadrant pattern had the shortest mean EPT among all 3 patterns (P < 0.05). The grid pattern is associated with higher intraocular pressure in hard nuclei (grades 4 and 5) than the other 2 patterns (P < 0.05).
CONCLUSIONS


The grid and quadrant patterns allow for shorter EPT in soft (grade 1) and hard (grades 4 and 5) nuclei, respectively. All 3 patterns can be selected for treating grade 2 nuclei. The sextant pattern may be the best option when treating grade 3 nuclei. The grid pattern should be avoided in hard nuclei combined with glaucoma or glaucoma suspect.",2020,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","['A total of 894 eyes in 661 patients with cataracts were enrolled', 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China']","['femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond Laser-assisted Cataract Surgery']","['mean EPT', 'nuclear density', 'endothelial cell density (ECD), endothelial cell loss (ECL) and central corneal thickness (CCT', 'intraoperative parameters, complications, and postoperative outcomes', 'Effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure (IOP', 'shorter mean EPT']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",661.0,0.031457,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Lyu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zeren', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Plastic Surgery, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ni', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China. Electronic address: xlren@zju.edu.cn.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.017']
908,30878219,Short term effect of yoga asana - An adjunct therapy to conventional treatment in frozen shoulder.,"BACKGROUND


The available treatments for frozen shoulder yield variable results. Physical therapy and analgesics are considered as the first-line treatment for this disorder, but the effects are not uniform. There is some evidence to support that alternative medicine may have a role in its management.
OBJECTIVE(S)


This study was designed to examine the short-term effects of yoga therapy in patients with frozen shoulder of mild to moderate severity.
MATERIALS AND METHODS


A prospective randomized controlled trial was conducted on patients with frozen shoulder between 30 and 60 years of age. They were divided into two groups: yoga (Y) and control (NY). A set of Asana exercises called ""Standing Group of Asana"" was practiced by the yoga group in addition to the conventional therapy as received by the control group. The patients were reviewed at 1, 2 and 4 weeks. The pain and functional assessment were done at baseline and at each review using the Shoulder Pain and Disability Index (SPADI).
RESULTS


There were 16 male and 20 female participants in the Y group, and 15 males and 21 females in the NY group. There was no statistically significant difference in age, sex, and pre-treatment SPADI score between the groups. At the end of the four weeks, the SPADI pain scores in the Y and NY group were 20.47 and 20.14, respectively (p = 0.666). The SPADI disability scores in the Y and NY group were 20.4 and 19.7, respectively (p = 0.599). Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736). Both groups had a significant reduction in SPADI pain and disability scores. However, there was no significant difference between the groups in terms of SPADI scores.
CONCLUSION


The effect of the Standing Group of Asana has no added advantage relative to standard frozen shoulder treatment when practiced for one month.",2020,"Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736).","['patients with frozen shoulder of mild to moderate severity', '16 male and 20 female participants in the Y group, and 15 males and 21 females in the NY group', 'frozen shoulder', 'patients with frozen shoulder between 30 and 60 years of age']","['yoga asana - An adjunct therapy', 'Asana exercises called ""Standing Group of Asana', 'yoga therapy']","['SPADI pain and disability scores', 'SPADI scores', 'Shoulder Pain and Disability Index (SPADI', 'age, sex, and pre-treatment SPADI score', 'pain and functional assessment', 'SPADI disability scores', 'SPADI pain scores', 'Overall SPADI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0264748,"Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736).","[{'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Orthopedics, AIIMS, Bhubaneswar, 751019, India. Electronic address: montu_jn@yahoo.com.'}, {'ForeName': 'Prabhas Ranjan', 'Initials': 'PR', 'LastName': 'Tripathy', 'Affiliation': 'Department of Anatomy & in Charge AYUSH, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Manik', 'Affiliation': 'Yoga Instructor, Department of AYUSH, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Sujit', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Orthopedics, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Binod', 'Initials': 'B', 'LastName': 'Behera', 'Affiliation': 'Department of Community Medicine, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Apurba', 'Initials': 'A', 'LastName': 'Barman', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, AIIMS, Bhubaneswar, 751019, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2018.12.007']
909,30893070,"Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects.","BACKGROUND


Human growth hormone (hGH) is best known for influencing bone and muscle growth, as well as body composition, but the use of recombinant hGH is controversial. Amino acids are a potentially safer alternative; however, preliminary investigations of the effects of oral amino acids on hGH release have been inconclusive. Therefore, we tested the effects of a novel blend of amino acids optimized to increase hGH release.
STUDY QUESTION


Does an investigational amino acid supplement affect hGH release?
STUDY DESIGN


This was a randomized, placebo-controlled, double-blind, crossover study that included 16 (12 men, 4 women; age 32 ± 14 years; body mass index 26.4 ± 5.0 kg/m) healthy participants. All participants received both placebo and the amino acid supplement after an overnight fast and completed all study visits. Treatment order was randomized, and each treatment was separated by a 1-week washout period.
MEASURES AND OUTCOMES


The primary outcomes were the percent change in hGH from baseline to 120 minutes and the area under the curve of hGH over baseline. Serum hGH was measured using enzyme-linked immunosorbent assay at baseline and 15, 30, 60, 90, and 120 minutes.
RESULTS


At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01). In addition, a significantly higher mean area under the curve was observed for the amino acid supplement compared with the placebo [20.4 (95% confidence interval, 19.9-21.0 ng/mL) vs. 19.7 (95% confidence interval, 18.7-20.6 ng/mL); P = 0.04].
CONCLUSIONS


These results show that a single dose of the oral amino acid supplement was sufficient to significantly increase hGH levels in healthy adult men and women. CLINICAL TRIAL REGISTRY:: clinicaltrials.gov NCT01540773.",2020,"At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01).","['Healthy Subjects', 'included 16 (12 men, 4 women; age 32 ± 14 years; body mass index 26.4 ± 5.0 kg/m) healthy participants', 'healthy adult men and women']","['placebo', 'placebo and the amino acid supplement', 'Placebo', 'Human growth hormone (hGH', 'oral amino acid supplement', 'amino acids', 'Amino Acid Supplement']","['Serum hGH', 'hGH release', 'hGH levels', 'Human Growth Hormone', 'percent change in hGH from baseline to 120 minutes and the area under the curve of hGH']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.610075,"At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01).","[{'ForeName': 'Charmaine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Heaton', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}]",American journal of therapeutics,['10.1097/MJT.0000000000000893']
910,30756142,"The Efficacy of Different Volumes on Ultrasound-Guided Type-I Pectoral Nerve Block for Postoperative Analgesia After Subpectoral Breast Augmentation: A Prospective, Randomized, Controlled Study.","BACKGROUND


PECS type-1 block, a US-guided superficial interfacial block, provides effective analgesia after breast surgery. Aesthetic breast augmentation is one of the most common surgical procedures in plastic surgery. Subpectoral prostheses cause severe pain. The aim of this study was to investigate the effect of different volumes of the solution on the efficacy of PECS type-I block for postoperative analgesia after breast augmentation surgery.
METHODS


Ninety ASA status I-II female patients aged between 18 and 65 years who scheduled breast augmentation surgery under general anesthesia were included in this study. The patients were randomly divided into three groups of 30 patients each (Group 20 = 20 ml of anaesthetic solution, Group 30 = 30 ml anaesthetic solution, and Group K = Control group). Postoperative assessment was performed using the VAS score. The VAS scores were recorded postoperatively at 1, 2, 4, 8, 16 and 24 h.
RESULTS


Fentanyl consumption was statistically significantly lower in Group 20 and Group 30 compared to the Control group (p < 0.05). There was no statistically significant difference in fentanyl consumption between Group 20 and Group 30. The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (p < 0.05). There was no statistical difference in terms of VAS scores between Group 20 and Group 30. The use of rescue analgesia was statistically lower in Groups 20 and 30.
CONCLUSIONS


PECS type-1 block using 20 ml of 0.25% bupivacaine can provide effective analgesia after breast augmentation surgery.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2019,The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (,"['Subpectoral prostheses cause severe pain', 'Ninety ASA status I-II female patients aged between 18 and 65\xa0years who scheduled breast augmentation surgery under general anesthesia were included in this study']","['IV', 'PECS type-I block', 'bupivacaine', 'anaesthetic solution, Group 30\u2009=\u200930\xa0ml anaesthetic solution, and Group K\u2009=\u2009Control group', 'Ultrasound-Guided Type-I Pectoral Nerve Block for Postoperative Analgesia']","['rescue analgesia', 'VAS score', 'fentanyl consumption', 'VAS scores', 'Fentanyl consumption', 'right and left VAS scores']","[{'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441845', 'cui_str': 'Group K (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",90.0,0.0430778,The right and left VAS scores were statistically significantly lower in Groups 20 and 30 than in the Control group (,"[{'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey. bciftci@medipol.edu.tr.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Erzurum Regional Training and Research Hospital, 25070, Yakutiye, Erzurum, Turkey.'}, {'ForeName': 'Muhammet Ahmet', 'Initials': 'MA', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, 34000, Bagcilar, Istanbul, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01322-8']
911,30808196,Effect of a multifactorial intervention on the increase in physical activity in subjects with type 2 diabetes mellitus: a randomized clinical trial (EMID Study).,"BACKGROUND


Regular physical activity is essential for metabolic control in type 2 diabetes mellitus.
AIMS


The aim of this study was to assess the short and long-term impact of a multifactorial intervention on physical activity and clinically relevant biochemical parameters in patients with type 2 diabetes mellitus.
METHODS


This randomised, controlled clinical trial (NCT02991079) included two parallel groups aged 25-70 years from a primary care health centre in Salamanca, Spain. The subjects were assigned randomly (1:1) to control and intervention groups, using Epidat 4.0 software. Both were counselled on the importance of physical activity and maintaining a healthy diet. The intervention group also took five low-moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop. Physical activity was measured objectively using a pedometer and subjectively using a shortened international physical activity questionnaire (at baseline, 3 and 12 months).
RESULTS


In total, 204 subjects were included (mean age 60.6 years, 45.6% were women). After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day. Differences from baseline persisted at 12 months, including mean increases of 1141 daily steps, 917 aerobic steps, and 1065 total metabolic equivalent minutes per week in the intervention group relative to the control group ( P<0.05 for all).
CONCLUSIONS


The success of this multifactorial intervention should help inform future clinical approaches and application designs towards managing type 2 diabetes mellitus and improving patient outcomes.",2019,"After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day.","['patients with type 2 diabetes mellitus', '204 subjects were included (mean age 60.6 years, 45.6% were women', 'subjects with type 2 diabetes mellitus', 'two parallel groups aged 25-70 years from a primary care health centre in Salamanca, Spain']","['multifactorial intervention', 'intervention group also took five low-moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop']","['international physical activity questionnaire', 'sedentary time', 'daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes', 'Physical activity', 'physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",204.0,0.048607,"After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Alonso-Domínguez', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Patino-Alonso', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Sánchez-Aguadero', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'García-Ortiz', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodríguez', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gómez-Marcos', 'Affiliation': '1 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, Spain.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119835048']
912,29105594,Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease.,"BACKGROUND


In a previous trial involving patients with early autosomal dominant polycystic kidney disease (ADPKD; estimated creatinine clearance, ≥60 ml per minute), the vasopressin V 2 -receptor antagonist tolvaptan slowed the growth in total kidney volume and the decline in the estimated glomerular filtration rate (GFR) but also caused more elevations in aminotransferase and bilirubin levels. The efficacy and safety of tolvaptan in patients with later-stage ADPKD are unknown.
METHODS


We conducted a phase 3, randomized withdrawal, multicenter, placebo-controlled, double-blind trial. After an 8-week prerandomization period that included sequential placebo and tolvaptan run-in phases, during which each patient's ability to take tolvaptan without dose-limiting side effects was assessed, 1370 patients with ADPKD who were either 18 to 55 years of age with an estimated GFR of 25 to 65 ml per minute per 1.73 m 2  of body-surface area or 56 to 65 years of age with an estimated GFR of 25 to 44 ml per minute per 1.73 m 2  were randomly assigned in a 1:1 ratio to receive tolvaptan or placebo for 12 months. The primary end point was the change in the estimated GFR from baseline to follow-up, with adjustment for the exact duration that each patient participated (interpolated to 1 year). Safety assessments were conducted monthly.
RESULTS


The change from baseline in the estimated GFR was -2.34 ml per minute per 1.73 m 2  (95% confidence interval [CI], -2.81 to -1.87) in the tolvaptan group, as compared with -3.61 ml per minute per 1.73 m 2  (95% CI, -4.08 to -3.14) in the placebo group (difference, 1.27 ml per minute per 1.73 m 2 ; 95% CI, 0.86 to 1.68; P<0.001). Elevations in the alanine aminotransferase level (to >3 times the upper limit of the normal range) occurred in 38 of 681 patients (5.6%) in the tolvaptan group and in 8 of 685 (1.2%) in the placebo group. Elevations in the aminotransferase level were reversible after stopping tolvaptan. No elevations in the bilirubin level of more than twice the upper limit of the normal range were detected.
CONCLUSIONS


Tolvaptan resulted in a slower decline than placebo in the estimated GFR over a 1-year period in patients with later-stage ADPKD. (Funded by Otsuka Pharmaceuticals and Otsuka Pharmaceutical Development and Commercialization; REPRISE ClinicalTrials.gov number, NCT02160145 .).",2017,The change from baseline in the estimated GFR was -2.34,"['patients with early autosomal dominant polycystic kidney disease (ADPKD', 'Later-Stage Autosomal Dominant Polycystic Kidney Disease', '1370 patients with ADPKD who were either 18 to 55 years of age with an estimated GFR of 25 to 65 ml per minute per 1.73 m 2  of body-surface area or 56 to 65 years of age with an estimated GFR of 25 to 44 ml per minute per 1.73 m 2', 'patients with later-stage ADPKD']","['tolvaptan', 'Tolvaptan', 'placebo', 'tolvaptan or placebo']","['alanine aminotransferase level', 'aminotransferase and bilirubin levels', 'aminotransferase level', 'bilirubin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}]",1370.0,0.687483,The change from baseline in the estimated GFR was -2.34,"[{'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Devuyst', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'McQuade', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Jaime D', 'Initials': 'JD', 'LastName': 'Blais', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sergeyeva', 'Affiliation': 'From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston (R.D.P.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.K.); and Otsuka Pharmaceutical Development and Commercialization, Rockville, MD (J.O., R.D.M., J.D.B., F.S.C., O.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1710030']
913,30837192,"Effectiveness of balance exercise among older adults in Depok City, Indonesia.","OBJECTIVE


Falls are a serious problem for older adults. Balance impairment is one of the most significant reasons why adults fall from a standing position. This study aims to investigate the effect of an eight-week postural balance exercise intended to reduce the risk of falls among older adults in a community in Depok City, Indonesia.
METHOD


This quasi-experimental study employed a pre- and post-test design using a control group. The study involved an intervention group of 30 respondents and a control group of a further 30 respondents. The sample was selected using multistage random sampling. The data were analyzed using a t-test.
RESULTS


The balance exercise significantly affected the respondents' postural balance and reduced their risk of falling. There were significant differences between the two groups (intervention group and control group) in postural balance (p < 0.001) and the risk of suffering a fall (p = 0.023). CONCLUSIóN: Balance exercises can be utilized as one of the preventive efforts to maintain postural balance and reduce the risk of falls among older adults. Future studies may consider the variation of age to more accurately determine the effectiveness of this balance exercise.",2020,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","['older adults in a community in Depok City, Indonesia', '30 respondents and a control group of a further 30 respondents', 'older adults in Depok City, Indonesia', 'older adults']","['balance exercise', 'eight-week postural balance exercise', 'Balance exercises']","['risk of falling', 'postural balance (p<.001) and the risk of suffering a fall (p=.023', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}]",,0.0211157,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","[{'ForeName': 'Stefanus Mendes', 'Initials': 'SM', 'LastName': 'Kiik', 'Affiliation': 'Stikes Maranatha Kupang, East Nusa Tenggara, Indonesia; Faculty of Nursing, Universitas Indonesia, West Java, Indonesia. Electronic address: stefanusmendeskiik@ymail.com.'}, {'ForeName': 'Junaiti', 'Initials': 'J', 'LastName': 'Sahar', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}, {'ForeName': 'Henny', 'Initials': 'H', 'LastName': 'Permatasari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.01.004']
914,28879629,Feasibility of Coping Effectiveness Training for Caregivers of Children with Autism Spectrum Disorder: a Genetic Counseling Intervention.,"Caregivers of children with autism spectrum disorder (ASD) may find it difficult to feel a sense of control and to cope with the overall physical and emotional demands of caring for their child. While caregivers are able to successfully cope with a high level of stress, there are limits to their resources and abilities to cope over time. Genetic counselors working with affected families may be able to help parents more effectively manage stress related to the disorder. Few short-term interventions have been reported in genetic counseling yet implementation of evidence-based examples may be achievable. This study aimed to assess the feasibility of a coping effectiveness training (CET) intervention designed to enhance coping self-efficacy (CSE) among caregivers of children with ASD, with the eventual goal of translating this intervention into genetic counseling practice. A randomized treatment-control design was used to investigate the feasibility of an intervention using CET among caregivers of children with ASD. The primary outcome was the feasibility of the intervention; the secondary outcome was improvements in CSE in the intervention group as compared to the control group. Caregivers were recruited and randomized into the treatment (n=15) or control (n=13) groups. Of these, 22 completed the study (retention: 78.6%). The intervention was highly feasible; most caregivers found the CET helpful, practical, useful, and relatively easy to attend. The treatment group demonstrated significantly increased CSE from pre-intervention to post-intervention (p=0.02). Between group differences were not significant when comparing the pre-post changes. We provide preliminary evidence that CET may be beneficial to caregivers of children with ASD. The results of this feasibility study support development of a phase II study of this intervention in a larger cohort, aimed to be implemented into a genetic counseling setting.",2018,The treatment group demonstrated significantly increased CSE from pre-intervention to post-intervention (p=0.02).,"['Caregivers of children with autism spectrum disorder (ASD', 'caregivers of children with ASD', 'Caregivers of Children with Autism Spectrum Disorder']","['coping effectiveness training (CET) intervention', 'CET', 'Coping Effectiveness Training']",['CSE'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0349403,The treatment group demonstrated significantly increased CSE from pre-intervention to post-intervention (p=0.02).,"[{'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Haakonsen Smith', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes Health, 31 Center Dr, MSC 2073, Building 31, Room B1B36, Bethesda, MD, 20892-2073, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Turbitt', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes Health, 31 Center Dr, MSC 2073, Building 31, Room B1B36, Bethesda, MD, 20892-2073, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Departent of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Leonard', 'Affiliation': 'Department of Development Sociology, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, National Institutes Health, Bethesda, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Freedman', 'Affiliation': 'Center for Disabilities Studies, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Muratori', 'Affiliation': 'Johns Hopkins Center for Talented Youth, Baltimore, MD, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes Health, 31 Center Dr, MSC 2073, Building 31, Room B1B36, Bethesda, MD, 20892-2073, USA. barbarab@mail.nih.gov.'}]",Journal of genetic counseling,['10.1007/s10897-017-0144-1']
915,30797045,"C-reactive protein, Epstein-Barr virus, and cortisol trajectories in refugee and non-refugee youth: Links with stress, mental health, and cognitive function during a randomized controlled trial.","Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion. Relatively few studies have examined, longitudinally, alterations to inflammatory processes during adolescence, especially outside Western contexts; none have evaluated biomarker trajectories for at-risk youth in response to a structured behavioral intervention. We conducted a randomized controlled trial evaluating the efficacy of a humanitarian intervention targeting stress-alleviation, with 12-18 year-old Syrian refugees (n = 446) and Jordanian non-refugees (n = 371) living side-by-side in war-affected communities in Jordan. We measured C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC) at three timepoints (pre/post intervention and 11 month follow-up), and assessed three main outcomes (psychosocial stress, mental health, and cognitive function). Using growth mixture models, regressions, and growth curve models, we identified three distinct trajectories for CRP, two for EBV, and three for HCC, and examined their associations with age, gender, BMI, poverty, and trauma. We found associations with BMI for CRP, refugee status for EBV, and BMI and gender with HCC trajectory. In terms of health outcomes, we found associations between rising CRP levels and perceived stress (B =  -2.92, p = .007), and between HCC hypersecretion and insecurity (B = 7.21, p = .017). In terms of responses to the intervention, we observed no differential impacts by CRP or EBV trajectories, unlike HCC. These results suggest that commonly-assayed biomarkers do not associate with health outcomes and respond to targeted interventions in straightforward ways. Our study is the first to examine multiple biomarker trajectories in war-affected adolescents, in order to better evaluate the extent, timing, and malleability of the biological signatures of poverty, conflict, and forced displacement.",2020,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.",['12-18\u202fyear-old Syrian refugees (n\u202f=\u202f446) and Jordanian non-refugees (n\u202f=\u202f371) living side-by-side in war-affected communities in Jordan'],['humanitarian intervention'],"['main outcomes (psychosocial stress, mental health, and cognitive function', 'C-reactive protein, Epstein-Barr virus, and cortisol trajectories', 'C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC', 'rising CRP levels and perceived stress', 'HCC hypersecretion and insecurity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0236525', 'cui_str': 'Epstein-Barr virus antibody (substance)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233497', 'cui_str': 'Insecurity (finding)'}]",,0.0231915,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Panter-Brick', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA. Electronic address: catherine.panter-brick@yale.edu.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wiley', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Sancilio', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Dajani', 'Affiliation': 'Department of Biology and Biotechnology, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hadfield', 'Affiliation': 'Department of Biological and Experimental Psychology, Queen Mary University of London, UK.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.02.015']
916,30776296,Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial.,"STUDY QUESTION


Does administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) in the first trimester improve pregnancy outcomes, among women with a history of unexplained recurrent pregnancy loss?
SUMMARY ANSWER


rhG-CSF administered in the first trimester of pregnancy did not improve outcomes among women with a history of unexplained recurrent pregnancy loss.
WHAT IS KNOWN ALREADY


The only previous randomized controlled study of granulocyte colony stimulating factor in recurrent miscarriage in 68 women with unexplained primary recurrent miscarriage found a statistically significant reduction in miscarriage and improvement in live birth rates. A further four observational studies where G-CSF was used in a recurrent miscarriage population were identified in the literature, two of which confirmed statistically significant increase in clinical pregnancy and live birth rates.
STUDY DESIGN, SIZE, DURATION


A randomized, double-blind, placebo controlled clinical trial involving 150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016. The study was coordinated by University of Birmingham, UK.
PARTICIPANTS/MATERIALS, SETTING, METHODS


One hundred and fifty women with a history of unexplained recurrent pregnancy loss: 76 were randomized to rhG-CSF and 74 to placebo. Daily subcutaneous injections of recombinant human granulocyte - colony stimulating factor 130 μg or identical appearing placebo from as early as three to five weeks of gestation for a maximum of 9 weeks. The trial used central randomization with allocation concealment. The primary outcome was clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan. Secondary outcomes included miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation. Analysis was by intention to treat.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 340 participants were screened for eligibility of which 150 women were randomized. 76 women (median age, 32[IQR, 29-34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26-33] years; mean BMI, 25.8[SD, 4.2]) were randomized to placebo. All women were followed-up to primary outcome, and beyond to live birth. The clinical pregnancy rate at 20 weeks, as well as the live birth rate, was 59.2% (45/76) in the rhG-CSF group, and 64.9% (48/74) in the placebo group, giving a relative risk of 0.9 (95% CI: 0.7-1.2; P = 0.48). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group. Neonatal congenital anomalies were observed in 1/46 (2.1%) of babies in the rhG-CSF group versus 1/49 (2.0%) in the placebo group (RR of 0.9; 95% CI: 0.1-13.4; P = 0.93).
LIMITATIONS, REASONS FOR CAUTION


This trial was conducted in women diagnosed with unexplained recurrent pregnancy loss and therefore no screening tests (commercially available) were performed for immune dysfunction related pregnancy failure/s.
WIDER IMPLICATIONS OF THE FINDINGS


To our knowledge, this is the first multicentre study and largest randomized clinical trial to investigate the efficacy and safety of granulocyte human colony stimulating factor in women with recurrent miscarriages. Unlike the only available single center RCT, our trial showed no significant increase in clinical pregnancy or live births with the use of rhG-CSF in the first trimester of pregnancy.
STUDY FUNDING/COMPETING INTEREST(S)


This study was sponsored and supported by Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301, USA. Darryl Carter was the co-founder and VP of research, Nora Therapeutics, Inc. and held shares in the company. He holds a patent for the use of recombinant human granulocyte colony stimulating factor to reduce unexplained recurrent pregnancy loss. Mark Joing, Paul Kwon and Jeff Tong were or are employees of Nora Therapeutics, Inc. No other potential conflict of interest relevant to this article was reported.
TRIAL REGISTRATION NUMBER


EUDRACT No: 2014-000084-40; ClinicalTrials.gov Identifier: NCT02156063.
TRIAL REGISTRATION DATE


31 Mar 2014.
DATE OF FIRST PATIENT’S ENROLMENT


23 Jun 2014.",2019,Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group.,"['women diagnosed with unexplained recurrent pregnancy loss and therefore no screening tests (commercially available) were performed for immune dysfunction related pregnancy failure/s', '76 women (median age, 32[IQR, 29-34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26-33] years; mean BMI, 25.8[SD, 4.2', 'women with a history of unexplained recurrent pregnancy loss', 'women with recurrent miscarriages', 'women with unexplained recurrent pregnancy losses', 'One hundred and fifty women with a history of unexplained recurrent pregnancy loss', '’S ENROLMENT\n\n\n23 Jun 2014', '68 women with unexplained primary recurrent miscarriage', '340 participants were screened for eligibility of which 150 women were randomized', '150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016']","['recombinant human granulocyte - colony stimulating factor 130 μg or identical appearing placebo', 'granulocyte human colony stimulating factor', 'placebo', 'rhG-CSF', 'recombinant human granulocyte colony stimulating factor (rhG-CSF', 'recombinant human granulocyte colony stimulating factor', 'granulocyte colony stimulating factor', 'Recombinant human granulocyte- colony stimulating factor']","['miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation', 'clinical pregnancy or live births', 'clinical pregnancy and live birth rates', 'live birth rate', 'clinical pregnancy rate', 'Neonatal congenital anomalies', 'Adverse events (AEs', 'miscarriage and improvement in live birth rates', 'clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0419373', 'cui_str': 'Livebirth (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]",150.0,0.578157,Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eapen', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Joing', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kwon', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maneta', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De Santo', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mussai', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lissauer', 'Affiliation': ""Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carter', 'Affiliation': 'Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey393']
917,30737992,"Follow-up, 18 months off house dust mite immunotherapy, of a randomized controlled study on the primary prevention of atopy.",,2019,,[],[],[],[],[],[],,0.0484786,,"[{'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Alviani', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Moyses', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': ""The David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Isle of Wight, UK.""}, {'ForeName': 'Zaraquiza', 'Initials': 'Z', 'LastName': 'Zolkipli', 'Affiliation': 'Department of Allergy, Addenbrookes NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Michaelis', 'Affiliation': 'Department of Immunology, Infectious Diseases and Allergy, Great North Children Hospital, Newcastle, UK.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Kurukulaaratchy', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Syed Hasan', 'Initials': 'SH', 'LastName': 'Arshad', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}]",Allergy,['10.1111/all.13744']
918,30795711,Advance Care Planning and Advance Directives: A Multimedia Education Program in Community-Dwelling Older Adults.,"This  community -based  cluster randomized trial  evaluated the efficacy of a 4-week multimedia educational intervention followed by telephone consultations at Weeks 12 and 24 on the selection of a hospice program for end-of-life care and completion of an advance directive (AD) in case of future advanced dementia. One hundred twenty-three cognitively intact older adults from five community centers in Taiwan were randomly assigned to two groups. The study showed that 100% of participants in the intervention group (two community centers,  n  = 52) selected hospice program care for end-of-life care and signed ADs, whereas those in the control group were less likely to do both ( p  < .001). Participants in the intervention group also had a positive change in knowledge, subjective norms, perceived behavioral control, and behavioral intention of advance care planning (ACP) for advanced dementia. The theoretically based multimedia educational program was effective in assisting ACP implementation and completing ADs among community-dwelling older adults.",2020,"Participants in the intervention group also had a positive change in knowledge, subjective norms, perceived behavioral control, and behavioral intention of advance care planning (ACP) for advanced dementia.","['One hundred twenty-three cognitively intact older adults from five community centers in Taiwan', 'community-dwelling older adults', 'Community-Dwelling Older Adults']","['multimedia educational intervention', 'Multimedia Education Program', 'Advance Care Planning and Advance Directives', 'advance directive (AD', 'multimedia educational program']","['hospice program care for end-of-life care and signed ADs', 'positive change in knowledge, subjective norms, perceived behavioral control, and behavioral intention of advance care planning (ACP) for advanced dementia']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086422', 'cui_str': 'Hospice Programs'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]",52.0,0.0250179,"Participants in the intervention group also had a positive change in knowledge, subjective norms, perceived behavioral control, and behavioral intention of advance care planning (ACP) for advanced dementia.","[{'ForeName': 'Chiu-Hsiang', 'Initials': 'CH', 'LastName': 'Chiu Wu', 'Affiliation': ""St. Mary's Hospital, Taitung City, Taiwan.""}, {'ForeName': 'Shoa-Jen', 'Initials': 'SJ', 'LastName': 'Perng', 'Affiliation': 'Tzu Chi University of Science and Technology, Hualien, Taiwan.'}, {'ForeName': 'Chun-Kuan', 'Initials': 'CK', 'LastName': 'Shi', 'Affiliation': 'Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Lai', 'Affiliation': 'Tzu Chi University, Hualien, Taiwan.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464819831596']
919,30795694,Job interview training targeting nonverbal communication using an android robot for individuals with autism spectrum disorder.,"Job interviews are significant barriers for individuals with autism spectrum disorder because these individuals lack good nonverbal communication skills. We developed a job interview training program using an android robot. The job interview training program using an android robot consists the following three stages: (1) tele-operating an android robot and conversing with others through the android robot, (2) a face-to-face mock job interview with the android robot, and (3) feedback based on the mock job interview and nonverbal communication exercises using the android robot. The participants were randomly assigned to the following two groups: one group received a combined intervention with ""interview guidance by teachers and job interview training program using an android robot"" ( n  = 13), and the other group received an intervention with interview guidance by teachers alone ( n  = 16). Before and after the intervention, the participants in both groups underwent a mock job interview with a human interviewer, who provided outcome measurements of nonverbal communication, self-confidence, and salivary cortisol. After the training sessions, the participants who received the combined interview guidance by teachers and the job interview training program using an android robot intervention displayed improved nonverbal communication skills and self-confidence and had significantly lower levels of salivary cortisol than the participants who only received interview guidance by teachers. The job interview training program using an android robot improved various measures of job interview skills in individuals with autism spectrum disorder.",2019,The job interview training program using an android robot improved various measures of job interview skills in individuals with autism spectrum disorder.,['individuals with autism spectrum disorder'],"['combined intervention with ""interview guidance by teachers and job interview training program using an android robot"" ( n \u2009=\u200913), and the other group received an intervention with interview guidance by teachers alone', 'job interview training program using an android robot consists the following three stages: (1) tele-operating an android robot and conversing with others through the android robot, (2) a face-to-face mock job interview with the android robot, and (3) feedback based on the mock job interview and nonverbal communication exercises using the android robot', 'job interview training program', 'job interview training program using an android robot', 'combined interview guidance by teachers and the job interview training program using an android robot intervention', 'mock job interview with a human interviewer', 'Job interview training targeting nonverbal communication using an android robot']","['levels of salivary cortisol', 'nonverbal communication skills and self-confidence', 'job interview skills']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028325', 'cui_str': 'Nonverbal Communication'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0028325', 'cui_str': 'Nonverbal Communication'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",,0.0107439,The job interview training program using an android robot improved various measures of job interview skills in individuals with autism spectrum disorder.,"[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Kumazaki', 'Affiliation': '1 Kanazawa University, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': '2 Keio University School of Medicine, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': '3 Osaka University, Japan.'}, {'ForeName': 'Blythe A', 'Initials': 'BA', 'LastName': 'Corbett', 'Affiliation': '5 Vanderbilt Kennedy Center, USA.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': '6 National Institute of Advanced Industrial Science and Technology, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': '1 Kanazawa University, Japan.'}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Yuhi', 'Affiliation': '1 Kanazawa University, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishiguro', 'Affiliation': '3 Osaka University, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': '2 Keio University School of Medicine, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Kikuchi', 'Affiliation': '1 Kanazawa University, Japan.'}]",Autism : the international journal of research and practice,['10.1177/1362361319827134']
920,30293664,Late sodium channel blockade improves angina and myocardial perfusion in patients with severe coronary microvascular dysfunction: Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction ancillary study.,"BACKGROUND


In a prior trial of late sodium channel inhibition (ranolazine) among symptomatic subjects without obstructive coronary artery disease (CAD) and limited myocardial perfusion reserve index (MPRI), we observed no improvement in angina or MPRI, overall. Here we describe the clinical characteristics and myocardial perfusion responses of a pre-defined subgroup who had coronary flow reserve (CFR) assessed invasively.
METHODS


Symptomatic patients without obstructive CAD and limited MPRI in a randomized, double-blind, crossover trial of ranolazine vs. placebo were subjects of this prespecified substudy. Because we had previously observed that adverse outcomes and beneficial treatment responses occurred in those with lower CFR, patients were subgrouped by CFR <2.5 vs ≥2.5. Symptoms were assessed using the Seattle Angina Questionnaire and the SAQ-7, and left-ventricular volume and MPRI were assessed by magnetic resonance imaging (MRI). Coronary angiograms, CFR, and MRI data were analyzed by core labs masked to treatment and patient characteristics.
RESULTS


During qualifying coronary angiography, 81 patients (mean age 55 years, 98% women) had invasively determined CFR 2.69 ± 0.65 (mean ± SD; range 1.4-5.5); 43% (n = 35) had CFR <2.5. Demographic and symptomatic findings did not differ comparing CFR subgroups. Those with low CFR had improved angina (p = 0.04) and midventricular MPRI (p = 0.03) with ranolazine vs placebo. Among patients with low CFR, reduced left-ventricular end-diastolic volume predicted a beneficial angina response.
CONCLUSIONS


Symptomatic patients with CFR <2.5 and no obstructive CAD had improved angina and myocardial perfusion with ranolazine, supporting the hypothesis that the late sodium channel is important in management of coronary microvascular dysfunction.
TRIAL REGISTRATION


clinicaltrials.gov Identifier NCT01342029.",2019,Those with low CFR had improved angina (p = 0.04) and midventricular MPRI (p = 0.03) with ranolazine vs placebo.,"['symptomatic subjects without obstructive coronary artery disease (CAD) and limited myocardial perfusion reserve index (MPRI', 'patients with severe coronary microvascular dysfunction', 'Symptomatic patients without obstructive CAD and limited MPRI', 'Symptomatic patients with CFR']","['placebo', 'ranolazine', 'Late sodium channel blockade', 'late sodium channel inhibition (ranolazine', 'ranolazine vs. placebo']","['midventricular MPRI', 'beneficial angina response', 'Seattle Angina Questionnaire and the SAQ-7, and left-ventricular volume and MPRI', 'adverse outcomes and beneficial treatment responses', 'coronary flow reserve (CFR) assessed invasively', 'Coronary angiograms, CFR, and MRI data', 'angina', 'angina or MPRI, overall', 'angina and myocardial perfusion']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1305363', 'cui_str': 'Catalytic fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0037492', 'cui_str': 'Ion Channels, Sodium'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305363', 'cui_str': 'Catalytic fraction'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}]",,0.346152,Those with low CFR had improved angina (p = 0.04) and midventricular MPRI (p = 0.03) with ranolazine vs placebo.,"[{'ForeName': 'Cecil A', 'Initials': 'CA', 'LastName': 'Rambarat', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Islam Y', 'Initials': 'IY', 'LastName': 'Elgendy', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Handberg', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'C Noel', 'Initials': 'CN', 'LastName': 'Bairey Merz', 'Affiliation': ""Barbara Streisand Women's Heart Center, Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, USA.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Barbara Streisand Women's Heart Center, Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, USA.""}, {'ForeName': 'Margo B', 'Initials': 'MB', 'LastName': 'Minissian', 'Affiliation': ""Barbara Streisand Women's Heart Center, Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, USA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Nelson', 'Affiliation': ""Barbara Streisand Women's Heart Center, Cedars-Sinai Smidt Heart Institute, Los Angeles, CA, USA.""}, {'ForeName': 'Louise E J', 'Initials': 'LEJ', 'LastName': 'Thomson', 'Affiliation': 'Departments of Medicine and Imaging, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Departments of Medicine and Imaging, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Program in Cardiovascular Outcomes Research and Epidemiology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Cook-Wiens', 'Affiliation': 'Biostatistics and Bioinformatics Research Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, USA. Electronic address: carl.pepine@medicine.ufl.edu.'}]",International journal of cardiology,['10.1016/j.ijcard.2018.09.081']
921,30782343,"Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial.","BACKGROUND


There is an urgent need for more effective therapies for glioblastoma. Data from a previous unrandomised phase 2 trial suggested that lomustine-temozolomide plus radiotherapy might be superior to temozolomide chemoradiotherapy in newly diagnosed glioblastoma with methylation of the MGMT promoter. In the CeTeG/NOA-09 trial, we aimed to further investigate the effect of lomustine-temozolomide therapy in the setting of a randomised phase 3 trial.
METHODS


In this open-label, randomised, phase 3 trial, we enrolled patients from 17 German university hospitals who were aged 18-70 years, with newly diagnosed glioblastoma with methylated MGMT promoter, and a Karnofsky Performance Score of 70% and higher. Patients were randomly assigned (1:1) with a predefined SAS-generated randomisation list to standard temozolomide chemoradiotherapy (75 mg/m 2  per day concomitant to radiotherapy [59-60 Gy] followed by six courses of temozolomide 150-200 mg/m 2  per day on the first 5 days of the 4-week course) or to up to six courses of lomustine (100 mg/m 2  on day 1) plus temozolomide (100-200 mg/m 2  per day on days 2-6 of the 6-week course) in addition to radiotherapy (59-60 Gy). Because of the different schedules, patients and physicians were not masked to treatment groups. The primary endpoint was overall survival in the modified intention-to-treat population, comprising all randomly assigned patients who started their allocated chemotherapy. The prespecified test for overall survival differences was a log-rank test stratified for centre and recursive partitioning analysis class. The trial is registered with ClinicalTrials.gov, number NCT01149109.
FINDINGS


Between June 17, 2011, and April 8, 2014, 141 patients were randomly assigned to the treatment groups; 129 patients (63 in the temozolomide and 66 in the lomustine-temozolomide group) constituted the modified intention-to-treat population. Median overall survival was improved from 31·4 months (95% CI 27·7-47·1) with temozolomide to 48·1 months (32·6 months-not assessable) with lomustine-temozolomide (hazard ratio [HR] 0·60, 95% CI 0·35-1·03; p=0·0492 for log-rank analysis). A significant overall survival difference between groups was also found in a secondary analysis of the intention-to-treat population (n=141, HR 0·60, 95% CI 0·35-1·03; p=0·0432 for log-rank analysis). Adverse events of grade 3 or higher were observed in 32 (51%) of 63 patients in the temozolomide group and 39 (59%) of 66 patients in the lomustine-temozolomide group. There were no treatment-related deaths.
INTERPRETATION


Our results suggest that lomustine-temozolomide chemotherapy might improve survival compared with temozolomide standard therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter. The findings should be interpreted with caution, owing to the small size of the trial.
FUNDING


German Federal Ministry of Education and Research.",2019,Median overall survival was improved from 31·4 months (95% CI 27·7-47·1) with temozolomide to 48·1 months (32·6 months-not assessable) with lomustine-temozolomide (hazard ratio [HR],"['enrolled patients from 17 German university hospitals who were aged 18-70 years, with newly diagnosed glioblastoma with methylated MGMT promoter, and a Karnofsky Performance Score of 70% and higher', '0·60', 'patients with newly diagnosed glioblastoma with methylated MGMT promoter', 'patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09', 'Between June 17, 2011, and April 8, 2014, 141 patients were randomly assigned to the treatment groups; 129 patients (63 in the']","['Lomustine-temozolomide combination therapy versus standard temozolomide therapy', 'lomustine-temozolomide', 'SAS-generated randomisation list to standard temozolomide chemoradiotherapy (75 mg/m 2  per day concomitant to radiotherapy', 'radiotherapy', 'lomustine-temozolomide therapy', 'temozolomide', 'lomustine-temozolomide (hazard ratio [HR', 'temozolomide chemoradiotherapy', 'lomustine-temozolomide group) constituted the modified intention-to-treat population', 'lomustine-temozolomide chemotherapy', 'lomustine-temozolomide plus radiotherapy', 'temozolomide standard therapy', 'lomustine']","['survival', 'overall survival', 'Adverse events', 'overall survival difference', 'Median overall survival', 'overall survival differences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",141.0,0.376698,Median overall survival was improved from 31·4 months (95% CI 27·7-47·1) with temozolomide to 48·1 months (32·6 months-not assessable) with lomustine-temozolomide (hazard ratio [HR],"[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany. Electronic address: ulrich.herrlinger@ukbonn.de.'}, {'ForeName': 'Theophilos', 'Initials': 'T', 'LastName': 'Tzaridis', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mack', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Joachim Peter', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schlegel', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sabel', 'Affiliation': 'Department of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hau', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Rolf-Dieter', 'Initials': 'RD', 'LastName': 'Kortmann', 'Affiliation': 'Department of Radiation Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Krex', 'Affiliation': 'Department of Neurosurgery, University of Dresden, Dresden, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grauer', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goldbrunner', 'Affiliation': 'Department of Neurosurgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Department of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany; Department of Neurosurgery, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Seidel', 'Affiliation': 'Department of Radiation Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Interdisciplinary Division of Neurooncology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kowalski', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery, Technical University of Munich, Munich, Germany; Department of Neurosurgery, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Schmidt-Graf', 'Affiliation': 'Department of Neurology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Bogdana', 'Initials': 'B', 'LastName': 'Suchorska', 'Affiliation': 'Department of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Brehmer', 'Affiliation': 'Department of Neurosurgery, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Weyerbrock', 'Affiliation': 'Department of Neurosurgery, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Renovanz', 'Affiliation': 'Department of Neurosurgery, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Department of Internal Medicine, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Galldiks', 'Affiliation': 'Department of Neurology, University of Cologne, Cologne, Germany; Institute of Neuroscience and Medicine (INM-3), Juelich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité University of Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misch', 'Affiliation': 'Department of Neurosurgery, Charité University of Berlin, Berlin, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Vatter', 'Affiliation': 'Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Stuplich', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Sied', 'Initials': 'S', 'LastName': 'Kebir', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weller', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schaub', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Stummer', 'Affiliation': 'Department of Neurosurgery, University of Münster, Münster, Germany.'}, {'ForeName': 'Jörg-Christian', 'Initials': 'JC', 'LastName': 'Tonn', 'Affiliation': 'Department of Neurosurgery, Ludwig Maximillian University of Munich and German Cancer Consortium, Partner Site Munich, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Vera C', 'Initials': 'VC', 'LastName': 'Keil', 'Affiliation': 'Department of Neuroradiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nelles', 'Affiliation': 'Department of Neuroradiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Urbach', 'Affiliation': 'Department of Neuroradiology, University Hospital Bonn, Bonn, Germany; Department of Neuroradiology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Coenen', 'Affiliation': 'Study Centre Bonn, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Department of Neurology, University of Heidelberg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schmid', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hattingen', 'Affiliation': 'Department of Neuroradiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Pietsch', 'Affiliation': 'Institute of Neuropathology and DGNN Brain Tumor Reference Centre, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Coch', 'Affiliation': 'Study Centre Bonn, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glas', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Centre of Integrated Oncology, University Hospital Bonn, Bonn, Germany; Division of Clinical Neurooncology, Department of Neurology and West German Cancer Center, German Cancer Consortium, Partner Site Essen, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)31791-4']
922,29807441,Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.,"PURPOSE


Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors.
DESIGN


A worksite-based randomized controlled trial.
SETTING


Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]).
PARTICIPANTS


Employees (n = 240) at the randomized worksites.
INTERVENTION


A 2.5-day group-based behavioral intervention.
MEASURES


Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months.
ANALYSIS


General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants.
RESULTS


As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors.
CONCLUSION


An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.",2019,"RESULTS


As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007).","['Twelve eligible worksites (8 randomized to the', 'Employees (n = 240) at the randomized worksites', 'Employee Well-Being']","['intervention group [IG] and 4 to the wait-listed control group [CG', 'Energy Management Training Course']","['SF-36 vitality scale', 'Rand Medical Outcomes Survey (MOS', 'life', 'weight, diet, physical activity, or cardiometabolic risk factors', 'mental health', 'social functioning', 'questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids', '36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies', 'employee quality of life (QoL) and health-related behaviors', 'sleep quality', 'employee QoL']","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.072432,"RESULTS


As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007).","[{'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Shawn T', 'Initials': 'ST', 'LastName': 'Mason', 'Affiliation': '2 Johnson & Johnson, Health and Wellness Solutions Inc, New Brunswick, NJ, USA.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Vail', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Gail V', 'Initials': 'GV', 'LastName': 'Rogers', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Kara A', 'Initials': 'KA', 'LastName': 'Livingston', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Jillian G', 'Initials': 'JG', 'LastName': 'Whelan', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'Chin', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Blanchard', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Turgiss', 'Affiliation': '2 Johnson & Johnson, Health and Wellness Solutions Inc, New Brunswick, NJ, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': '1 Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118776875']
923,31311779,RE: Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.,,2020,,['oesophagogastric variceal bleeding'],['haemostatic powder added to standard management'],[],"[{'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.080814,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnston', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ryan Malcolm', 'Initials': 'RM', 'LastName': 'Buchanan', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK ryan.buchanan@nhs.net.'}]",Gut,['10.1136/gutjnl-2019-319272']
924,30779100,Role of phase angle in the evaluation of effect of an immuno-enhanced formula in post-surgical cancer patients: a randomized clinical trial.,"OBJECTIVE


Neoplastic disease is frequently associated with poor nutritional status or severe malnutrition. Diet and nutritional intervention are becoming increasingly important for prognosis and quality of life in cancer patients. Accessible and repeatable tools for assessing nutritional status with body composition techniques seems to be fundamental. The aim of this study was to evaluate the effects of immunonutrition on body composition parameters, inflammatory response and nutritional status in patients at stage III of head and neck squamous carcinoma (HNSCC).
PATIENTS AND METHODS


In our work, 50 malnourished subjects with HNSCC staging III were recruited and treated with oral diet (OD) or enteral nutrition (EN). Patient under EN followed, for the first three days, enteral standard nutrition (ESN) and then enteral immunonutrition (EIN). Nutrition state was evaluated on days 0, 3, and 8 through body composition and biochemical analyses.
RESULTS


After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
CONCLUSIONS


Our results showed that immunonutrition treatment improves the nutritional status of neoplastic patients, supporting chemotherapy. The phase angle is not only a predictor of cancer survival, but has also proved to be useful in the surveillance of nutritional status improvement as well as biochemical indices.",2019,"After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
","['post-surgical cancer patients', 'cancer patients', '50 malnourished subjects with HNSCC staging III', 'patients at stage III of head and neck squamous carcinoma (HNSCC']","['oral diet (OD) or enteral nutrition (EN', 'immunonutrition', 'immuno-enhanced formula', 'Diet and nutritional intervention', 'enteral standard nutrition (ESN) and then enteral immunonutrition (EIN']","['cancer survival', 'body composition parameters, inflammatory response and nutritional status', 'Nutrition state', 'phase angle, pre-albumin, retinol binding protein and transferrin']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}]",50.0,0.022038,"After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Renzo', 'Affiliation': 'Section of Clinical Nutrition and Nutrigenomic, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy. laura.di.renzo@uniroma2.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cioccoloni', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gratteri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Capria', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Soldati', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Mele', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cintoni', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lorenzo', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201902_17027']
925,30757908,Efficacy of a nurse-led lipid-lowering secondary prevention intervention in patients hospitalized for ischemic heart disease: A pilot randomized controlled trial.,"BACKGROUND AND AIMS


Lack of achievement of secondary prevention objectives in patients with ischaemic heart disease remains an unmet need in this patient population. We aimed at evaluating the six-month efficacy of an intensive lipid-lowering intervention, coordinated by nurses and implemented after hospital discharge, in patients hospitalized for an ischaemic heart disease event.
METHODS


Randomized controlled trial, in which a nurse-led intervention including periodic follow-up, serial lipid level controls, and subsequent optimization of lipid-lowering therapy, if appropriate, was compared with standard of care alone in terms of serum lipid-level control at six months after discharge.
RESULTS


The nurse-led intervention was associated with an improved management of low-density lipoprotein (LDL) cholesterol levels compared with standard of care alone: LDL cholesterol levels ⩽100 mg/dL were achieved in 97% participants in the intervention arm as compared with 67% in the usual care arm ( p value <0.001), the LDL cholesterol ⩽70 mg/dL target recommended by the 2016 European Society of Cardiology guidelines was achieved in 62% vs. 37% participants ( p value 0.047) and the LDL cholesterol reduction of ⩾50% recommended by the American College of Cardiology/American Heart Association in 2013 was achieved in 25.6% of participants in the intervention arm as compared with 2.6% in the usual care arm ( p value 0.007). The intervention was also associated with improved blood pressure control among individuals with hypertension.
CONCLUSIONS


Our findings highlight the opportunity that nurse-led, intensive, post-discharge follow-up plans may represent for achieving LDL cholesterol guideline-recommended management objectives in patients with ischaemic heart disease. These findings should be replicated in larger cohorts.",2019,"The nurse-led intervention was associated with an improved management of low-density lipoprotein (LDL) cholesterol levels compared with standard of care alone: LDL cholesterol levels ⩽100 mg/dL were achieved in 97% participants in the intervention arm as compared with 67% in the usual care arm ( p value <0.001), the LDL cholesterol ⩽70 mg/dL target recommended by the 2016 European Society of Cardiology guidelines was achieved in 62% vs. 37% participants ( p value 0.047) and the LDL cholesterol reduction of ⩾50% recommended by the American College of Cardiology/American Heart Association in 2013 was achieved in 25.6% of participants in the intervention arm as compared with 2.6% in the usual care arm ( p value 0.007).","['patients hospitalized for an ischaemic heart disease event', 'patients hospitalized for ischemic heart disease', 'individuals with hypertension', 'patients with ischaemic heart disease']","['nurse-led lipid-lowering secondary prevention intervention', 'intensive lipid-lowering intervention, coordinated by nurses and implemented after hospital discharge']","['LDL cholesterol reduction', 'low-density lipoprotein (LDL) cholesterol levels', 'blood pressure control', 'LDL cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.116111,"The nurse-led intervention was associated with an improved management of low-density lipoprotein (LDL) cholesterol levels compared with standard of care alone: LDL cholesterol levels ⩽100 mg/dL were achieved in 97% participants in the intervention arm as compared with 67% in the usual care arm ( p value <0.001), the LDL cholesterol ⩽70 mg/dL target recommended by the 2016 European Society of Cardiology guidelines was achieved in 62% vs. 37% participants ( p value 0.047) and the LDL cholesterol reduction of ⩾50% recommended by the American College of Cardiology/American Heart Association in 2013 was achieved in 25.6% of participants in the intervention arm as compared with 2.6% in the usual care arm ( p value 0.007).","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ruiz-Bustillo', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Consol', 'Initials': 'C', 'LastName': 'Ivern', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Badosa', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Farre', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Marco', 'Affiliation': '4 Department of Physical Medicine and Rehabilitation, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bruguera', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Cladellas', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': '5 Bellvitge University Hospital and Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cainzos-Achirica', 'Affiliation': '5 Bellvitge University Hospital and Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Marti-Almor', 'Affiliation': '1 Department of Cardiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': '5 Bellvitge University Hospital and Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119831511']
926,21060260,Effect of systane and optive on aqueous tear evaporation in patients with dry eye disease.,"OBJECTIVE


To compare the effect on aqueous tear (AT) evaporation rate of Systane and Optive at 30 min postinstillation in patients with dry eye.
METHODS


In a crossover study of 20 patients with keratoconjunctivitis sicca, the evaporation rate of AT was measured. Evaporometry was used at two relative humidity (RH) ranges of 25% to 35% and 35% to 45%. The measurements were made at baseline (before the instillation of the study agent) and at 30 min after the instillation of 40 μL of either Systane or Optive per randomization assignment per visit with a 1-week interval between visits.
RESULTS


No significant effects on AT evaporation rates at both RHs were found between study agents.
CONCLUSIONS


In our study, neither Systane nor Optive has a significant impact on AT evaporation at 30 min postinstillation in patients with dry eye.",2010,"No significant effects on AT evaporation rates at both RHs were found between study agents.
","['20 patients with keratoconjunctivitis sicca', 'patients with dry eye disease', 'patients with dry eye']",['systane and optive'],"['evaporation rate of AT', 'AT evaporation rates', 'aqueous tear (AT) evaporation rate of Systane and Optive']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022575', 'cui_str': 'Keratoconjunctivitis Sicca'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1655274', 'cui_str': 'Systane'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1655274', 'cui_str': 'Systane'}]",20.0,0.0282585,"No significant effects on AT evaporation rates at both RHs were found between study agents.
","[{'ForeName': 'Jadwiga C', 'Initials': 'JC', 'LastName': 'Wojtowicz', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-9057, USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Arciniega', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McCulley', 'Affiliation': ''}, {'ForeName': 'V Vinod', 'Initials': 'VV', 'LastName': 'Mootha', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0b013e3181f9b36e']
927,30762087,Acute reconstruction results in less sick-leave days and as such fewer indirect costs to the individual and society compared to delayed reconstruction for ACL injuries.,"PURPOSE


To compare the total number of sick-leave days caused by the knee injury from the day of injury and over the first year between acute (within 8 days) and delayed (6-10 weeks) anterior cruciate ligament reconstruction (ACLR) and also assess other clinical outcomes during this period.
METHODS


Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8 days) or delayed (after 6-10 weeks) ACLR. Patient-reported outcomes; objective IKDC and manual stability measurements were assessed at 6 and 12 months. With data from the Swedish Social Insurance Agency (Försäkringskassan) information about the number of sick-leave days due to the knee injury over the following 12 months was collected and compared between the two groups.
RESULTS


Seventy-one percent received compensation for sick leave (26 in the acute versus 23 in the delayed group). The mean number of sick-leave days for the acute group was significantly lower (M = 56.9, SD = 36.4) compared to the delayed group (M = 88.5, SD = 50.2), p < 0.05. The acute group was also significantly stronger in flexion in both slow and fast angle velocities according to Biodex ® . No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
CONCLUSION


Acute and delayed ACLR provided comparable clinical outcomes after 12 months. Acute reconstruction resulted in less sick-leave days and as such fewer indirect costs to the individual and society. These findings suggest that if patients requiring ACLR can be identified early and ACLR can be performed in the acute phase, socioeconomic costs can potentially be reduced by minimizing time off work.
LEVEL OF EVIDENCE


II.",2020,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","['With data from the Swedish Social Insurance Agency ', 'Seventy patients with an acute ACL injury and Tegner level of 6 or more were randomized to acute (within 8\xa0days) or delayed (after 6-10\xa0weeks']",['anterior cruciate ligament reconstruction (ACLR'],"['flexion in both slow and fast angle velocities', 'compensation for sick leave', 'total number of sick-leave days', 'outcomes; objective IKDC and manual stability measurements', 'mean number of sick-leave days']","[{'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.0674861,"No other differences were found between the groups in other clinical assessments or in terms of associated injuries.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'McCallum', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05397-3']
928,30172703,Purified CD34 +  cells versus peripheral blood mononuclear cells in the treatment of angiitis-induced no-option critical limb ischaemia: 12-Month results of a prospective randomised single-blinded non-inferiority trial.,"BACKGROUND


Peripheral blood mononuclear cells (PBMNCs) and purified CD34 +  cells (PCCs) are increasingly being used at treating no-option critical limb ischaemia (NO-CLI). We aimed to compare the efficacies and uncover the advantages associated with each treatment approach.
METHODS


A randomised single-blinded non-inferiority trial (Number: NCT 02089828) was performed. NO-CLI patients were 1:1 randomised to the PBMNCs and PCCs groups, and compared in relation to safety and efficacy outcomes. The primary efficacy outcomes included major amputation and total amputation over 12 months. The major amputation-free survival (MAFS) and total amputation-free survival (TAFS) rates were calculated.
FINDINGS


Fifty patients (25 per group, 47 with thromboangiitis obliterans and 3 with other angiitis) were enrolled, with a median follow-up period of 24.5 months (interquartile range: 17-34 months). One patient in the PCCs group was lost at 2 months and one major amputation occurred in the PBMNCs group at 3 months post-transplantation. The total amputation rates at 6 months post-transplantation were 28.0% in the PCCs group and 16.0% in the PBMNCs group (p = 0.343), and remained unchanged at 12 months. The groups did not differ regarding the MAFS and TAFS (Breslow-Wilcoxon test: p = 0.3014 and p = 0.3414). The PCCs group had a significantly higher probability of rest pain relief than the PBMNCs group (Breslow-Wilcoxon test: p = 0.0454).
INTERPRETATION


PCCs was not inferior to PBMNCs at limb salvage in the treatment of angiitis-induced NO-CLI and appeared to induce earlier ischaemia relief. Each cell type had specific advantages. These outcomes require verification from longer-term trials involving larger numbers of patients. FUND: Training program for outstanding academic leaders of Shanghai health and family planning system (Hundred Talent Program，Grant No. 2018BR40); China National Natural Science Funds (Grant No. 30801122); The excellent core member training programme at Zhongshan Hospital, Fudan University, China (Grant No. 2015ZSYXGG02); and Zhongshan Funds for the Institute of Vascular Surgery, Fudan University, China.
CLINICAL TRIAL REGISTRATION


This study is registered with ClinicalTrials.gov (NCT 02089828).",2018,The groups did not differ regarding the MAFS and TAFS,"['NO-CLI patients', 'outstanding academic leaders of Shanghai health and family planning system (Hundred Talent Program，Grant No. 2018BR40); China National Natural Science Funds (Grant No. 30801122); The excellent core member training programme at Zhongshan Hospital, Fudan University, China ', 'FUND', 'angiitis-induced no-option critical limb ischaemia', 'Fifty patients (25 per group, 47 with thromboangiitis obliterans and 3 with other angiitis']","['purified CD34 +  cells (PCCs', 'MAFS and TAFS', 'Purified CD34 +  cells versus peripheral blood mononuclear cells', 'Training program']","['ischaemia relief', 'major amputation', 'probability of rest pain relief', 'total amputation rates', 'major amputation-free survival (MAFS) and total amputation-free survival (TAFS) rates', 'major amputation and total amputation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0039269', 'cui_str': 'Talent'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0678530', 'cui_str': 'Natural Sciences'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042384', 'cui_str': 'Angiitis'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040021', 'cui_str': 'Buerger Disease'}]","[{'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0767702,The groups did not differ regarding the MAFS and TAFS,"[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China. Electronic address: dong.zhihui@zs-hospital.sh.cn.'}, {'ForeName': 'Tianyue', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shiyang', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Core Lab of Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Daqiao', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China. Electronic address: fu.weiguo@zs-hospital.sh.cn.'}]",EBioMedicine,['10.1016/j.ebiom.2018.08.038']
929,31694759,"Medium-chain triglycerides improved cognition and lipid metabolomics in mild to moderate Alzheimer's disease patients with APOE4 -/- : A double-blind, randomized, placebo-controlled crossover trial.","BACKGROUND


Previous clinical and animal studies suggested that medium-chain triglycerides (MCT) might be an alternative energy substrate for the brain and might benefit patients with Alzheimer's disease (AD), but the clinical evidence is not substantial or totally convincing.
OBJECTIVE


To investigate the effects of MCT on cognitive ability in patients with mild to moderate AD and explore the changes in peripheral blood metabolomics.
METHODS


A double-blind, randomized, placebo-controlled crossover study was undertaken in 53 mild to moderate AD patients. Participants were randomized between two sequences (placebo followed by MCT or MCT followed by placebo) and took MCT jelly or placebo jelly (canola oil) by mouth three times daily (total daily fat dose: 17.3 g MCT, or 19.7 g canola oil) for 30 days per phase. The primary outcome was cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version (ADAS-Cog-C). The secondary outcome was self-care as measured by the activities of daily living scale (ADL) and changes in plasma metabolites.
RESULTS


This study showed a significant (p < 0.01) reduction in ADAS-Cog-C scores between the MCT (2.62 points below baseline) and placebo interventions (2.57 points above baseline). Data from 46 (86.8%) APOE4 -/-  subjects who completed the entire study were analyzed. Changes in ADL scores were not significantly different between the MCT and placebo interventions (p > 0.05). The concentrations of TC, HDL-C, β-hydroxybutyrate and acetoacetate were significantly higher in the MCT group than in the placebo group (p < 0.05). Lysophosphatidylcholine 16:0 (LysoPC (16:0)), LysoPC (P-18:0), LysoPC (P-18:1(9Z)), LysoPC (20:2(11Z,14Z)), and LysoPC (22:5(4Z,7Z,10Z,13Z,16Z)) were significantly increased after MCT intervention, and the concentrations of LysoPC (18:0), palmitic acid, linoleic acid, oleic acid, and 7,12-dimethylbenz[a]anthracene were significantly decreased (p < 0.05), whereas no significant changes appeared after the placebo intervention. Androstenedione concentration increased after placebo intervention. Furthermore, a significant negative correlation was observed between changes in LysoPC (P-18:1(9Z)) and ADAS-Cog-C scores after MCT intervention (r = -0.1472, p < 0.05).
CONCLUSIONS


MCT had positive effects on cognitive ability in mild to moderate AD patients with APOE4 -/- . These effects of MCT might be related to the metabolism of LysoPC, oleic acid, linoleic acid and palmitic acid, in addition to the ketogenic effect.
STUDY ID NUMBER


ChiCTR-IOR-16009737.
REGISTRY WEBSITE


WHO ICTRP Search Portal - http://apps.who.int/trialsearch/Default.aspx.",2020,"The concentrations of TC, HDL-C, β-hydroxybutyrate and acetoacetate were significantly higher in the MCT group than in the placebo group (p < 0.05).","[""patients with Alzheimer's disease (AD"", ""mild to moderate Alzheimer's disease patients with APOE4"", 'patients with mild to moderate AD', '53 mild to moderate AD patients']","['LysoPC', 'Medium-chain triglycerides', 'medium-chain triglycerides (MCT', 'g canola oil', 'sequences (placebo followed by MCT or MCT followed by placebo) and took MCT jelly or placebo jelly (canola oil', 'placebo', 'Lysophosphatidylcholine 16:0 ', 'APOE4', 'MCT', 'P-18:1(9Z']","['cognition and lipid metabolomics', 'self-care as measured by the activities of daily living scale (ADL) and changes in plasma metabolites', 'Changes in ADL scores', 'LysoPC (20:2(11Z,14Z)), and LysoPC (22:5(4Z,7Z,10Z,13Z,16Z', 'concentrations of LysoPC (18:0), palmitic acid, linoleic acid, oleic acid, and 7,12-dimethylbenz[a]anthracene', 'concentrations of TC, HDL-C, β-hydroxybutyrate and acetoacetate', 'changes in LysoPC (P-18:1(9Z)) and ADAS-Cog-C scores', ""cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version (ADAS-Cog-C"", 'Androstenedione concentration', 'ADAS-Cog-C scores', 'cognitive ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0767389', 'cui_str': 'Apo-E4(Freiburg)'}]","[{'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0453543', 'cui_str': 'Jello'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithins'}, {'cui': 'C0767389', 'cui_str': 'Apo-E4(Freiburg)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030234', 'cui_str': 'Palmitic Acid'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0028929', 'cui_str': 'Oleic Acids'}, {'cui': 'C0000677', 'cui_str': '7,12-Dimethylbenz(a)anthracene'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0220778', 'cui_str': '3-ketobutyrate'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.619968,"The concentrations of TC, HDL-C, β-hydroxybutyrate and acetoacetate were significantly higher in the MCT group than in the placebo group (p < 0.05).","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Xinsheng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Department of Neurology, the Second Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Mo', 'Affiliation': 'School of Medicine, Nankai University, Tianjin, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Fan-Xing Biological Technology Co., Ltd., Beijing, PR China.'}, {'ForeName': 'Huizi', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nutrition, Chinese People's Liberation Army Rocket Force Characteristic Medical Center, Beijing, PR China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Chinese People's Liberation Army Air Force Medical Center, Beijing, PR China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China. Electronic address: liuyinghua77@163.com.""}, {'ForeName': 'Changyong', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': ""Department of Nutrition, the First Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, PR China. Electronic address: cnxcy@163.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.10.017']
930,30659990,Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial.,"BACKGROUND & AIMS


Mucosal exposure devices improve detection of lesions during colonoscopy and have reduced examination times in uncontrolled studies. We performed a randomized trial of Endocuff Vision vs standard colonoscopy to compare differences in withdrawal time (the primary end point). We proposed that Endocuff Vision would allow complete mucosal inspection in a shorter time without impairing lesion detection.
METHODS


Adults older than 40 years undergoing screening or surveillance colonoscopies were randomly assigned to the Endocuff group (n=101, 43.6% women) or the standard colonoscopy group (n=99; 57.6% women). One of 2 experienced endoscopists performed the colonoscopies, aiming for a thorough evaluation of the proximal sides of all haustral folds, flexures, and valves in the shortest time possible. Inspection time was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time.
RESULTS


There were significantly fewer women in the Endocuff arm (P = .0475) but there were no other demographic differences between groups. Mean insertion time with Endocuff was 4.0 min vs 4.4 min for standard colonoscopy (P = .14). Mean inspection time with Endocuff was 6.5 min vs 8.4 min for standard colonoscopy (P < .0001). Numbers of adenomas detected per colonoscopy (1.43 vs 1.07; P = .07), adenoma detection rate (61.4% vs 52%; P = .21), number of sessile serrated polyps per colonoscopy (0.27 vs 0.21; P = .12), and sessile serrated polyp detection rate (19.8% vs 11.1%; P = .09) were all higher with Endocuff Vision. Results did not differ significantly when we controlled for age, sex, or race.
CONCLUSION


In a randomized trial, we found inclusion of Endocuff in screening or surveillance colonoscopies to decrease examination time without reducing lesion detection. ClinicalTrials.gov, Number: NCT03361917.",2020,There were significantly fewer women in the Endocuff arm (P = .0475),"['Adults older than 40 years undergoing screening or surveillance colonoscopies', 'group (n=101, 43.6% women) or the standard colonoscopy group (n=99; 57.6% women']","['Endocuff Vision', 'Endocuff Vision vs standard colonoscopy', 'Endocuff']","['Numbers of adenomas detected per colonoscopy', 'Mean inspection time with Endocuff', 'number of sessile serrated polyps per colonoscopy', 'Inspection time', 'Mean insertion time with Endocuff', 'adenoma detection rate', 'withdrawal time', 'sessile serrated polyp detection rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated polyp'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.235681,There were significantly fewer women in the Endocuff arm (P = .0475),"[{'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Rex', 'Affiliation': 'Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: drex@iu.edu.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Slaven', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lahr', 'Affiliation': 'Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Searight', 'Affiliation': 'Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Gross', 'Affiliation': 'Division of Gastroenterology, Tisch Hospital, NYU Langone Medical Center, New York, New York.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.01.015']
931,30732967,[Non-randomized trial to evaluate a continuous physiotherapy program versus interval in overweight patients suffering from acute coronary syndrome].,"We present a non-randomised trial to evaluate a continuous physiotherapy program versus a periodic one in overweight patients suffering from acute coronary syndrome.
AIM


To detect differences between a continuous (CONT) physiotherapy program (PF) and a periodic (INT) physiotherapy program in overweight patients with acute coronary syndrome on anthropometric parameters, analytical parameters, heart rate, adherence, drop-outs, safety and tolerance.
DESIGN


A multicentre, non-randomised two-armed quasi-experimental study with pre-post design.
LOCATION


Community cardiac prevention centres (Manises, Valencia-LaFe, Játiva-Onteniente Health Department).
PARTICIPANTS


The study included a total of 339 overweight participants with acute coronary syndrome; living in the community; aged more than 18; no contraindication for physical exercise; no previous participation in a PF.
INTERVENTIONS


Participants were assigned to a CONT training or an INT training (2 months). Each session was divided in warm-up, endurance, and cool-down. Endurance was performed at 12-13 Borg intensity and with heat rate calculated, with maximum heat rate obtained in the baseline ergometry.
MAIN MEASUREMENTS


Body mass index, waist circumference, lipid profile, blood glucose, glycosylated haemoglobin, resting heat rate, adherence, drop-outs, safety, and tolerance were assessed.
RESULTS


The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate. No differences were observed in adherence, drop-outs, safety, and tolerance.
CONCLUSIONS


The CONT group obtained better results in all variables except for HDL cholesterol. Both programs offered a high adherence, safety, and tolerance.",2020,"The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate.","['overweight patients suffering from acute coronary syndrome', 'overweight patients with acute coronary syndrome', '339 overweight participants with acute coronary syndrome; living in the community; aged more than 18; no contraindication for physical exercise; no previous participation in a PF']","['continuous physiotherapy program', 'continuous (CONT) physiotherapy program (PF) and a periodic (INT) physiotherapy program', 'CONT training or an INT training']","['HDL cholesterol', 'anthropometric parameters, analytical parameters, heart rate, adherence, drop-outs, safety and tolerance', 'adherence, drop-outs, safety, and tolerance', 'body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate', 'Body mass index, waist circumference, lipid profile, blood glucose, glycosylated haemoglobin, resting heat rate, adherence, drop-outs, safety, and tolerance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",339.0,0.0279091,"The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate.","[{'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Olivares Jara', 'Affiliation': 'Departamento de Salud Manises, Servicio de Cardiología, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Vázquez Arce', 'Affiliation': 'Departamento de Salud La Fe, Servicio de Rehabilitación y Medicina Física, Hospital Universitario y Politécnico La Fe, Valencia, España; Universidad San Vicente Mártir, Valencia, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Peña Pachés', 'Affiliation': 'Departamento de Salud Manises, Servicio de Rehabilitación, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Roser Mas', 'Affiliation': 'Departamento de Salud Manises, Servicio de Rehabilitación, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Pérez-Alenda', 'Affiliation': 'Departamento de Fisioterapia, Universidad de Valencia, Valencia, España.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marques-Sule', 'Affiliation': 'Departamento de Fisioterapia, Universidad de Valencia, Valencia, España; Departamentos de Salud Valencia, Instituto Valenciano del Corazón, Játiva, Onteniente, Valencia, España. Electronic address: elena.marques@uv.es.'}]",Atencion primaria,['10.1016/j.aprim.2018.09.015']
932,31684841,Comparing mismatch strategies for patients being considered for ischemic stroke tenecteplase trials.,"BACKGROUND


Currently there are multiple variations of imaging-based patient selection mismatch methods in ischemic stroke. In the present study, we sought to compare the two most common mismatch methods and identify if there were different effects on the outcome of a randomized clinical trial depending on the mismatch method used.
AIMS


Investigate the effect of clinical and imaging-based mismatch criteria on patient outcomes of a pooled cohort from randomized trials of intravenous tenecteplase versus alteplase.
METHODS


Baseline clinical and imaging scores were used to categorize patients as meeting either the DAWN mismatch (baseline NIHSS ≥ 10, and age cut-offs for ischemic core volume) or DEFUSE 2 mismatch criteria (mismatch volume > 15 mL, mismatch ratio > 1.8 and ischemic core < 70 mL). We then investigated whether tenecteplase-treated patients had favorable odds of less disability (on modified Rankin scale, mRS) compared to those treated with alteplase, for clinical and imaging mismatch, respectively.
RESULTS


From 146 pooled patients, 71 received alteplase and 75 received tenecteplase. The overall pooled group did not show improved patient outcomes when treated with tenecteplase (mRS 0-1 OR 1.77, 95% CI 0.89-3.51,  p  = 0.102) compared with alteplase. A total of 39 (27%) patients met both clinical and imaging mismatch criteria, 25 (17%) patients met only imaging criteria, 36 (25%) met only clinical mismatch criteria and, finally, 46 (31%) did not meet either of imaging or mismatch criteria. Patients treated with tenecteplase had more favorable outcomes when they met either imaging mismatch (mRS 0-1, OR 2.33, 95% CI 1.13-5.94,  p  = 0.032) or clinical mismatch criteria (mRS 0-1, OR 2.15, 95% CI 1.142, 8.732,  p  = 0.027) but with differing proportions.
CONCLUSION


Target mismatch selection was more inclusive and exhibited in a larger treatment effect between tenecteplase and alteplase.",2020,"The overall pooled group did not show improved patient outcomes when treated with tenecteplase (mRS 0-1 OR 1.77, 95% CI 0.89-3.51,  p  = 0.102) compared with alteplase.","['From 146 pooled patients, 71 received alteplase and 75 received tenecteplase', 'A total of 39 (27%) patients met both clinical and imaging mismatch criteria, 25 (17%) patients met only imaging criteria, 36 (25%) met only clinical mismatch criteria and, finally, 46 (31%) did not meet either of imaging or mismatch criteria', 'patients being considered for ischemic stroke tenecteplase trials', 'categorize patients as meeting either the DAWN mismatch (baseline NIHSS\u2009≥\u200910, and age cut-offs for ischemic core volume) or DEFUSE 2 mismatch criteria (mismatch volume\u2009>\u200915\u2009mL, mismatch ratio\u2009>\u20091.8 and ischemic core\u2009<\u200970\u2009mL']","['intravenous tenecteplase versus alteplase', 'clinical and imaging-based mismatch criteria']",['patient outcomes'],"[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C1518543', 'cui_str': 'Off (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.18553,"The overall pooled group did not show improved patient outcomes when treated with tenecteplase (mRS 0-1 OR 1.77, 95% CI 0.89-3.51,  p  = 0.102) compared with alteplase.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Xuya', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Departments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Bruce Cv', 'Initials': 'BC', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Bharath K', 'Initials': 'BK', 'LastName': 'Cheripelli', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Chushuang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Departments of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Kalladka', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Moreton', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019884529']
933,30269534,Implementing e-learning and e-tools for care home staff supporting residents with dementia and challenging behaviour: A process evaluation of the ResCare study using normalisation process theory.,"Dementia-related symptoms, sometimes termed challenging or distressing behaviour, can give rise to significant distress in care homes. Individualised formulation-led interventions show promise in reducing these behaviours. ResCare, a cluster randomised controlled trial in England, tested an online individualised intervention, comprising e-learning and decision support e-tools, designed to enable staff to better support residents with such symptoms. Normalisation process theory was used to understand the implementation processes. We analysed contextual process data for all 27 'intervention' care homes and identified three implementation mechanisms. These were examined for four illustrative case study homes. Seven qualitative interviews with care home staff and one interview with two research therapists informed this understanding. The main barrier to implementation was difficulty in conveying a sustained understanding of the value of individually tailored interventions. Emphasis was placed on training rather than practice change. Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve. Take up of e-learning and e-tools proved hard. There may be a need to continually promote 'buy-in' of the potential benefits of individualised formulation-led interventions, and this would have to be congruent with other priorities. Interventions within care homes need to consider organisational readiness, capacity for innovation and ongoing appraisal and adjustment to maintain changes in practice.",2020,Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve.,"['care home staff supporting residents with dementia and challenging behaviour', ""all 27 'intervention' care homes and identified three implementation mechanisms""]",[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0474414', 'cui_str': 'Challenging behavior (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]",[],[],,0.0272904,Implementation seemed easier in smaller homes and in those with flexible managerial styles where transfer of knowledge and skill might have been easier to achieve.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keenan', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Manthorpe', 'Affiliation': ""Social Care Workforce Research Unit, King's College London, UK.""}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Hart', 'Affiliation': 'R&D Department, Humber NHS Foundation Trust, UK.'}, {'ForeName': 'Esme', 'Initials': 'E', 'LastName': 'Moniz-Cook', 'Affiliation': 'Faculty of Health Sciences, School of Health and Social Care, University of Hull, UK.'}]","Dementia (London, England)",['10.1177/1471301218803195']
934,30043749,"Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial.","BACKGROUND


Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus.
METHODS


In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of systemic lupus erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02708095.
FINDINGS


Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0-3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7-2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo.
INTERPRETATION


The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for systemic lupus erythematosus.
FUNDING


Eli Lilly and Company.",2018,"Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group.","['Patients with systemic lupus erythematosus', 'Eligible patients were aged 18 years or older, had a diagnosis of systemic lupus erythematosus, and had active disease involving skin or joints', '314 patients', 'patients were recruited from 78 centres in 11 countries', 'systemic lupus erythematosus', 'patients who received at least one dose of study drug', 'patients with systemic lupus erythematosus', 'Between March 24, 2016, and April 27, 2017']","['placebo', 'baricitinib 2 mg (n=105), or baricitinib 4 mg', 'Baricitinib', 'JAK1/2 inhibition with baricitinib', 'receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo']","['proportion of patients achieving resolution of arthritis or rash', 'Serious infections', 'Adverse events', 'signs and symptoms of active systemic lupus erythematosus', 'resolution of SLEDAI-2K arthritis or rash', 'Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4694845', 'cui_str': 'baricitinib 2 MG [Olumiant]'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index (assessment scale)'}, {'cui': 'C0470277', 'cui_str': '2000'}]",314.0,0.656068,"Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Division of Rheumatology, Cedars-Sinai Medical Center, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: danielwallac@gmail.com.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Division of Rheumatology, Zucker School of Medicine at Hofstra, Northwell, New York, NY, USA.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Kalunian', 'Affiliation': 'Division of Rheumatology, University of California at San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mosca', 'Affiliation': 'Division of Rheumatology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'Division of Rheumatology, Charite Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Cardiel', 'Affiliation': 'Centro de Investigación Clínica de Morelia SC, Morelia, México.'}, {'ForeName': 'Ian N', 'Initials': 'IN', 'LastName': 'Bruce', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gomez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Carmack', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Linnik', 'Affiliation': 'Lilly Biotechnology Center, San Diego, CA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Silk', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)31363-1']
935,20147743,FGFR4 Arg388 genotype is associated with pathological complete response to neoadjuvant chemotherapy for primary breast cancer.,"BACKGROUND


A single-nucleotide polymorphism (SNP) in the FGFR4 gene is associated with poor prognosis in solid tumors. A recent study presented the first evidence that FGFR4 Arg388 could predict resistance to adjuvant chemotherapy in breast cancer. The present study evaluates the potential of this SNP to predict response to neoadjuvant chemotherapy (NCT) for primary breast cancer (PBC).
METHODS


As part of a randomized phase II trial, 257 patients received either doxorubicin-cyclophosphamide (AC) or doxorubicin-pemetrexed (AP) followed by docetaxel (Doc; Taxotere) as NCT for T2-4/N0-2/M0 PBC. FGFR4 genotype analyzed on germline DNA was correlated with clinicopathologic variables, clinical response, and pathological complete response (pCR) using univariate and multivariate analyses.
RESULTS


Only axillary lymph node status was associated with FGFR4 Arg388 [odds ratio (OR) 1.82, P = 0.03]. Joint analysis of both treatment arms revealed a correlation of FGFR4 Arg388 with clinical response (OR 2.14, P = 0.03) but not with pCR. In the AC-Doc arm, however, FGFR4 Arg388 was a strong predictor of pCR in the multivariate analysis (OR 3.79, P = 0.03). A significant interaction between FGFR4 genotype and treatment (P = 0.01) was found, indicating a therapy-specific effect.
CONCLUSION


We provide the evidence that FGFR4 388Arg is an independent predictor of pCR following AC-Doc as NCT in PBC.",2010,"Only axillary lymph node status was associated with FGFR4 Arg388 [odds ratio (OR) 1.82, P = 0.03].","['257 patients received either', 'primary breast cancer', 'primary breast cancer (PBC']","['doxorubicin-cyclophosphamide (AC) or doxorubicin-pemetrexed (AP) followed by docetaxel (Doc; Taxotere', 'neoadjuvant chemotherapy (NCT']","['clinicopathologic variables, clinical response, and pathological complete response (pCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",257.0,0.0550921,"Only axillary lymph node status was associated with FGFR4 Arg388 [odds ratio (OR) 1.82, P = 0.03].","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Heidelberg; Department of Molecular Genetics. Electronic address: Frederik.Marme@med.uni-heidelberg.de.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Werft', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Burwinkel', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Heidelberg; Department of Molecular Epidemiology, German Cancer Research Center.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sinn', 'Affiliation': 'Institute of Pathology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Heidelberg.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lichter', 'Affiliation': 'Department of Molecular Genetics.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Department of Molecular Genetics.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Heidelberg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq017']
936,30702055,"Identifying critical psychotherapy targets in serious cardiac conditions: The importance of addressing coping with symptoms, healthcare navigation, and social support.","OBJECTIVE


In seriously ill cardiac patients, several psychotherapy efficacy studies demonstrate little to no reduction in depression or improvement in quality of life, and little is known about how to improve psychotherapies to best address the range of patient needs. An interpersonal and behavioral activation psychotherapy was a key component of the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) multisite randomized clinical trial. Although depressive symptoms did improve in the CASA trial, questions remain about how best to tailor psychotherapies to the needs of seriously ill patient populations. The study objective was to describe psychosocial needs emerging during a clinical trial of a palliative care and interpersonal and behavioral activation psychotherapy intervention that were not specifically addressed by the psychotherapy.
METHOD


During the CASA trial, patient needs were prospectively tracked by the psychotherapist in each visit note using an a priori code list. Preplanned analysis of study data using directed content analysis was conducted analyzing the a priori code list, which were collapsed by team consensus into larger themes. The frequency of each code and theme were calculated into a percentage of visits.
RESULT


A total of 150 patients received one or more visits from the therapist and were included in the analysis. Participants screened positive for depressive disorder (47%), had poor heart failure-specific health status (mean Kansas City Cardiomyopathy Questionnaire score = 48.6; SD = 17.4), and multiple comorbidities (median 4.3). Common needs that emerged during the therapy included difficulty coping with fatigue (48%), pain (28%), and satisfaction issues with medical care (43%). The following broader themes emerged: social support (77% of sessions), unmet symptom needs (67%), healthcare navigation (48%), housing, legal, safety, and transportation (32%), and end of life (12%).
SIGNIFICANCE OF RESULTS


Coping with chronic symptoms and case management needs commonly emerged during psychotherapy visits. Future psychotherapy interventions in seriously ill populations should consider the importance of coping with chronic symptoms and case management.",2019,"The following broader themes emerged: social support (77% of sessions), unmet symptom needs (67%), healthcare navigation (48%), housing, legal, safety, and transportation (32%), and end of life (12%).Significance of resultsCoping with chronic symptoms and case management needs commonly emerged during psychotherapy visits.","['serious cardiac conditions', 'seriously ill cardiac patients', '150 patients received one or more visits from the therapist and were included in the analysis', 'Participants screened positive for depressive disorder (47%), had poor heart failure-specific health status (mean Kansas City Cardiomyopathy Questionnaire score = 48.6; SD = 17.4), and multiple comorbidities (median 4.3']","['healthcare navigation', 'palliative care and interpersonal and behavioral activation psychotherapy intervention']",['pain'],"[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",150.0,0.0897475,"The following broader themes emerged: social support (77% of sessions), unmet symptom needs (67%), healthcare navigation (48%), housing, legal, safety, and transportation (32%), and end of life (12%).Significance of resultsCoping with chronic symptoms and case management needs commonly emerged during psychotherapy visits.","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Bekelman', 'Affiliation': 'Department of Medicine, Eastern Colorado Healthcare System, Department of Veterans Affairs, Denver, Colorado.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult & Child Consortium for Outcome Research & Delivery Science, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Turvey', 'Affiliation': 'University of Iowa Carver College of Medicine and Iowa City VA Health Care System, Comprehensive Access and Delivery Research and Evaluation Center, Iowa City, IA.'}]",Palliative & supportive care,['10.1017/S1478951518001037']
937,31899888,"The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women.","BACKGROUND


The benefits of weight loss programs on mood, cognitive, and motor behavior are largely limited to those of calorie restriction or exercise alone. Our aim was to investigate the effect of combined calorie restriction and aerobic exercise intervention on mood, brain activity, and cognitive and motor behavior in overweight and obese women.
METHODS


Participants aged 36-56 years were randomized to either a control or an experimental group (aerobic exercise + 12.5% energy intake reduction) for a 6-month period. Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance were assessed.
RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05). Brain-derived neurotrophic factor level and learning of a speed-accuracy task remained unchanged. Although prefrontal cortex activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < .05). An improvement in reaction time during the speed-accuracy task was observed (P < .05).
CONCLUSION


Combined calorie restriction and aerobic exercise intervention improved the psychosocial state, had little impact on cognition, and no effect on brain activity and learning of the speed-accuracy task.",2020,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","['Overweight and Obese Women', 'overweight and obese women', 'Participants aged 36-56 years']","['control or an experimental group (aerobic exercise + 12.5% energy intake reduction', 'Combined calorie restriction and aerobic exercise intervention', 'Combined Aerobic Exercise and Calorie Restriction', 'combined calorie restriction and aerobic exercise intervention']","['reaction time of visual scanning and associative learning', 'Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance', 'reaction time', 'Mood, Cognition, and Motor Behavior', 'Confusion and depression', 'tension', 'brain activity and learning of the speed-accuracy task', 'mood, brain activity, and cognitive and motor behavior', 'prefrontal cortex activity and executive functions']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0600082', 'cui_str': '% energy intake (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0337271,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': ''}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': ''}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Vizbaraitė', 'Affiliation': ''}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': ''}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0373']
938,30734583,Effect of combined neurofeedback and game-based cognitive training on the treatment of ADHD: A randomized controlled study.,"Neurofeedback (NF) is referred to as a ""possibly efficacious"" treatment in the current evidence-based reviews; therefore, more research is needed to determine its effects especially in combination with other treatments. The present study examines the effect of NF and game-based cognitive training on children with attention deficit hyperactivity disorder (ADHD). Thirty-two male students with ADHD were assigned to NF ( N  = 16;  M age =10.20;  SD  = 1.03) and waiting list control ( N  = 16;  M age  = 10.05;  SD  = 0.83) in a randomized double-blind trial. The children in the NF group based on quantitative electroencephalography (QEEG) attended 30 three times-weekly sessions. The children were examined in pretest and post-test with EEG, Integrated Visual and Auditory Continuous Performance (IVA), and Conners Parent, and Teacher Rating Scales-Revised. The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC). Normalization of the atypical EEG features with reduced [Formula: see text] wave and increased sensory motor (SMR) activity in central zero (Cz) was recorded in the NF condition participants. However, except for SMR activity there were no significant changes in the waves of frontocentral zero (FCz). It is concluded that technology developments provide an interesting vehicle for interposing interventions and that combined NF and game-based cognitive training can produce positive therapeutic effects on brainwaves and ADHD symptomatology.",2020,The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC).,"['children with attention deficit hyperactivity disorder (ADHD', 'Thirty-two male students with ADHD were assigned to NF (N\u2009=\u200916; M age =10.20; SD\u2009=\u20091.03) and waiting list control (N\u2009=\u200916; M age  = 10.05; SD\u2009=\u20090.83', 'ADHD']","['Neurofeedback (NF', 'combined neurofeedback and game-based cognitive training', 'NF and game-based cognitive training']","['EEG, Integrated Visual and Auditory Continuous Performance (IVA), and Conners Parent, and Teacher Rating Scales-Revised', 'symptom variables except for attention deficit (AD) and auditory response control (ARC', 'quantitative electroencephalography (QEEG', 'sensory motor (SMR) activity in central zero (Cz', 'waves of frontocentral zero (FCz', 'SMR activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",32.0,0.0373183,The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC).,"[{'ForeName': 'Soran', 'Initials': 'S', 'LastName': 'Rajabi', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Pakize', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}, {'ForeName': 'NozhatAlzaman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}]",Applied neuropsychology. Child,['10.1080/21622965.2018.1556101']
939,31682461,[Influence of rs670 variant of APOA1 gene on serum HDL response to an enriched-polyunsaturated vs. an enriched-monounsaturated fat hypocaloric diet].,"Introduction


Background and objectives: genetic variants of the APOA1 gene have been related to lipid profile in obese subjects. Our aim was to analyze the effects of the rs670 APOA1 gene polymorphism on metabolic changes secondary to an enriched-polyunsaturated fat vs. an enriched-monounsaturated fat hypocaloric diet. Methods: 360 Caucasian obese subjects were randomly allocated to two groups. One group received an enriched-polyunsaturated fat (diet P) and the other an enriched-monounsaturated fat hypocaloric diet (diet M) during 12 weeks. The effects on serum biomarkers related to lipid and carbohydrate metabolism were evaluated before and after the dietary intervention. Results: after both diets, body mass index, weight, fat mass, waist circumference, systolic blood pressure, plasma leptin concentration, and waist circumference decreased in all patients. After 12 weeks of intervention with diet P, plasma insulin levels and HOMA-IR decreased in A-allele carriers: delta: -7.3 ± 2.2 IU/L (p = 0.01), and delta: -2.8 ± 0.5 units (p = 0.02), respectively. The same changes in delta were observed after diet M in A-allele carriers: insulin delta: -5.9 ± 1.2 IU/L (p = 0.01), and HOMA-IR delta: -2.1 ± 0.8 units (p = 0.02). In A-allele carriers, LDL-cholesterol decreased and HDL-cholesterol increased after the dietary intervention with diet P: delta: -12.1 ± 4.3 mg/dL (p = 0.01), and delta: 2.6 ± 0.7 mg/dL (p = 0.01), respectively. No differences in lipid profile were observed after diet M. These improvements were not observed in non-A-allele carriers after both interventions. Conclusions: our study showed the association of the rs670 ApoA1 polymorphism with insulin resistance changes as induced by both diets. An enriched-polyunsaturated fat diet produced an additional improvement of HDL-cholesterol and LDL-cholesterol in A-allele carriers.",2019,"After 12 weeks of intervention with diet P, plasma insulin levels and HOMA-IR decreased in A-allele carriers: delta: -7.3 ± 2.2 IU/L (p = 0.01), and delta: -2.8 ± 0.5 units (p = 0.02), respectively.","['360 Caucasian obese subjects', 'obese subjects']",['enriched-polyunsaturated fat (diet P) and the other an enriched-monounsaturated fat hypocaloric diet (diet M'],"['lipid profile', 'lipid and carbohydrate metabolism', 'plasma insulin levels and HOMA-IR', 'serum HDL response', 'LDL-cholesterol decreased and HDL-cholesterol', 'body mass index, weight, fat mass, waist circumference, systolic blood pressure, plasma leptin concentration, and waist circumference', 'HDL-cholesterol and LDL-cholesterol']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0302820', 'cui_str': 'Carbohydrate Metabolism'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",360.0,0.0310132,"After 12 weeks of intervention with diet P, plasma insulin levels and HOMA-IR decreased in A-allele carriers: delta: -7.3 ± 2.2 IU/L (p = 0.01), and delta: -2.8 ± 0.5 units (p = 0.02), respectively.","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'de Luis Román', 'Affiliation': 'Departamento de Endocrinología y Nutrición. Hospital Clínico Universitario.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola Jáuregui', 'Affiliation': 'Departamento de Endocrinología y Nutrición. Hospital Clínico Universitario.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Departamento de Endocrinología y Nutrición. Hospital Clínico Universitario.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Departamento de Endocrinología y Nutrición. Hospital Clínico Universitario.'}]",Nutricion hospitalaria,['10.20960/nh.02390']
940,31693994,A Controlled Evaluation of a CBPR Intervention's Effects on Physical Activity and the Related Psychosocial Constructs Among Minority Children in an Underserved Community.,"BACKGROUND


Effective physical activity interventions are needed for children because health behaviors track into adulthood, and risk factors for diseases begin early in life. No study has determined whether an intervention designed using a Community-Based Participatory Research approach can improve moderate to vigorous physical activity (MVPA) and the related psychosocial constructs in underserved children. This study determined whether improvements in MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills) occurred following a Community-Based Participatory Research intervention in underserved, rural children. It was then determined if these constructs were mediators of MVPA.
METHODS


Two fifth-grade classes at a school (n = 19 and n = 20) were randomly assigned to an intervention or comparison group. The intervention group participated in a 4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey). Groups were assessed prior to and immediately following the intervention.
RESULTS


There were no differences at baseline between groups. MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05). Knowledge and skills were mediating variables of MVPA.
CONCLUSIONS


Priority should be placed on research that determines the sustained impact of similar Community-Based Participatory Research interventions.",2020,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","['Minority Children in an Underserved Community', 'underserved, rural children', 'underserved children', 'Two fifth-grade classes at a school (n = 19 and n = 20']","['4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey', 'Community-Based Participatory Research intervention', ""CBPR Intervention's""]","['knowledge, and skill scores', 'MVPA', 'MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills', 'Physical Activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0256111,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","[{'ForeName': 'Kara C', 'Initials': 'KC', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Shanda', 'Initials': 'S', 'LastName': 'McGraw', 'Affiliation': ''}, {'ForeName': 'Teirdre', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Higginbotham', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0135']
941,28591198,Single dose primaquine to reduce gametocyte carriage and Plasmodium falciparum transmission in Cambodia: An open-label randomized trial.,"BACKGROUND


Single low dose primaquine (SLD PQ, 0.25mg/kg) is recommended in combination with artemisinin-based combination therapy (ACT) as a gametocytocide to prevent Plasmodium falciparum transmission in areas threatened by artemisinin resistance. To date, no randomized controlled trials have measured primaquine's effect on infectiousness to Anopheline mosquitoes in Southeast Asia.
METHODS


Cambodian adults with uncomplicated falciparum malaria were randomized to receive a single 45mg dose of primaquine (equivalent to three SLD PQ) or no primaquine after the third dose of dihydroartemisin-piperaquine (DHP) therapy. A membrane-feeding assay measured infectiousness to Anopheles dirus on days 0, 3, 7, and 14 of blood-stage therapy. Gametocytemia was evaluated by microscopy and reverse-transcriptase PCR.
RESULTS


Prior to trial halt for poor DHP treatment efficacy, 101 participants were randomized and 50 received primaquine. Overall microscopic gametocyte prevalence was low (9%), but gametocytemic subjects given primaquine were gametocyte-free by day 14, and significantly less likely to harbor gametocytes by day 7 compared to those treated with DHP-alone, who remained gametocytemic for a median of two weeks. Only one infectious subject was randomized to the primaquine group, precluding assessment of transmission-blocking efficacy. However, he showed a two-fold reduction in oocyst density of infected mosquitoes less than 24 hours after primaquine dosing. In the DHP-alone group, four subjects remained infectious through day 14, infecting roughly the same number of mosquitoes pre and post-treatment. Overall, microscopic gametocytemia was an excellent predictor of infectiousness, and performed better than submicroscopic gametocytemia post-treatment, with none of 474 mosquitoes infected post-treatment arising from submicroscopic gametocytes.
CONCLUSIONS


In a setting of established ACT resistance, a single dose of 45mg primaquine added to DHP rapidly and significantly reduced gametocytemia, while DHP-alone failed to reduce gametocytemia and prevent malaria transmission to mosquitoes. Continued efforts to make single dose primaquine widely available are needed to help achieve malaria elimination.",2017,"Overall, microscopic gametocytemia was an excellent predictor of infectiousness, and performed better than submicroscopic gametocytemia post-treatment, with none of 474 mosquitoes infected post-treatment arising from submicroscopic gametocytes.
","['101 participants were randomized and 50 received', 'Cambodian adults with uncomplicated falciparum malaria', 'Anopheline mosquitoes in Southeast Asia', 'Cambodia']","['primaquine (equivalent to three SLD PQ) or no primaquine after the third dose of dihydroartemisin-piperaquine (DHP) therapy', 'primaquine', 'artemisinin-based combination therapy (ACT', 'primaquine (SLD PQ']","['Overall microscopic gametocyte prevalence', 'oocyst density']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0003983', 'cui_str': 'Southeast Asia'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0444529', 'cui_str': 'Oocysts'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",101.0,0.105676,"Overall, microscopic gametocytemia was an excellent predictor of infectiousness, and performed better than submicroscopic gametocytemia post-treatment, with none of 474 mosquitoes infected post-treatment arising from submicroscopic gametocytes.
","[{'ForeName': 'Jessica T', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Chanthap', 'Initials': 'C', 'LastName': 'Lon', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Phnom Penh, Cambodia.'}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Spring', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Somethy', 'Initials': 'S', 'LastName': 'Sok', 'Affiliation': 'Royal Cambodian Armed Forces, Phnom Penh, Cambodia.'}, {'ForeName': 'Soklyda', 'Initials': 'S', 'LastName': 'Chann', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Phnom Penh, Cambodia.'}, {'ForeName': 'Mali', 'Initials': 'M', 'LastName': 'Ittiverakul', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Worachet', 'Initials': 'W', 'LastName': 'Kuntawunginn', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Mok', 'Initials': 'M', 'LastName': 'My', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Phnom Penh, Cambodia.'}, {'ForeName': 'Kheangheng', 'Initials': 'K', 'LastName': 'Thay', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Rifat', 'Initials': 'R', 'LastName': 'Rahman', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Mengchuor', 'Initials': 'M', 'LastName': 'Char', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Lanteri', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Panita', 'Initials': 'P', 'LastName': 'Gosi', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Ratawan', 'Initials': 'R', 'LastName': 'Ubalee', 'Affiliation': 'Department of Entomology, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Meshnick', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Saunders', 'Affiliation': 'Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0168702']
942,30904248,Comparison of the postoperative analgesic efficacies of intravenous acetaminophen and fascia iliaca compartment block in hip fracture surgery: A randomised controlled trial.,"BACKGROUND


Managing pain during movement after hip fracture surgery is important for achieving earlier hip mobilisation and for preventing postoperative complications. In the present study, we tested the hypothesis that the fascia iliaca compartment block (FICB) would improve postoperative pain on movement compared with intravenous acetaminophen.
METHODS


In this prospective, randomised, controlled, parallel trial, patients were assigned to either the intravenous acetaminophen or the ultrasound-guided FICB group. Visual analog scale (VAS) pain scores were evaluated at 6, 9, 12, 18, 24 h, 2 days, and 7 days postoperatively. The primary outcome was VAS scores on movement at 24 h after surgery. The secondary outcomes were VAS scores on movement at the other time points, VAS scores at rest, the total number of rescue analgesics required and incidence of delirium during the first 24 h postoperatively, potential drug or block-related complications, and the time to first standing.
RESULTS


VAS scores on movement at 24 h after surgery were significantly lower in the FICB group than in the intravenous acetaminophen group [median (the 25th to 75th percentiles), 20 (10-30) vs 40 (30-53); P < 0.01]. The VAS scores on movement at any other time point and the scores at rest at 12 h after surgery were also significantly lower in the FICB group than in the intravenous acetaminophen group. The two groups did not differ in terms of the total number of rescue analgesics required or the incidence of delirium during the first 24 h postoperatively; complications; or the time to first standing.
CONCLUSIONS


FICB improved postoperative pain on movement compared with intravenous acetaminophen without increasing the complication rate. However, the total number of rescue analgesics required and the time to first standing were not significantly different between the two groups.",2019,"RESULTS


VAS scores on movement at 24 h after surgery were significantly lower in the FICB group than in the intravenous acetaminophen group [median (the 25th to 75th percentiles), 20 (10-30) vs 40 (30-53); P < 0.01].",['fracture surgery'],"['acetaminophen', 'FICB', 'fascia iliaca compartment block (FICB', 'acetaminophen and fascia iliaca compartment block']","['postoperative pain', 'VAS scores on movement at 24\u2009h after surgery', 'VAS scores on movement at the other time points, VAS scores at rest, the total number of rescue analgesics required and incidence of delirium during the first 24\u2009h postoperatively, potential drug or block-related complications, and the time to first standing', 'Visual analog scale (VAS) pain scores', 'total number of rescue analgesics required or the incidence of delirium during the first 24\u2009h postoperatively; complications; or the time to first standing', 'VAS scores', 'complication rate', 'total number of rescue analgesics required and the time to first standing']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}]",,0.147822,"RESULTS


VAS scores on movement at 24 h after surgery were significantly lower in the FICB group than in the intravenous acetaminophen group [median (the 25th to 75th percentiles), 20 (10-30) vs 40 (30-53); P < 0.01].","[{'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopaedic Surgery, Unnan City Hospital, Shimane, Japan. Electronic address: norio-yamamoto@umin.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anaesthesiology, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Department of Musculoskeletal Traumatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Orthopaedic Surgery, Unnan City Hospital, Shimane, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': ""Dan'ura"", 'Affiliation': 'Department of Orthopaedic Surgery, Unnan City Hospital, Shimane, Japan.'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'Department of Orthopaedic Surgery, Unnan City Hospital, Shimane, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Ozaki', 'Affiliation': 'Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama, Japan.'}]",Injury,['10.1016/j.injury.2019.03.008']
943,30696285,"A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study.","Objectives:  Literature suggests that graded and multicomponent therapy improves outcomes in fibromyalgia, but there is no conclusive evidence in which combination to be used. This study focused on the effect of a multicomponent therapy in fibromyalgia when a combination of exercise therapy and cognitive behavioural therapy was applied. Additionally, predictors for dropping out were explored as research reports high dropout rates. Methods:  Participants received graded multicomponent therapy for 12 weeks, twice a week during two hours every session by an occupational therapist, a physiotherapist, and a psychologist. Following outcome measures were assessed at baseline, weeks 6 and 12: Fibromyalgia Impact Questionnaire, Tampa scale for kinesiophobia, the Beck Depression Index, the Pain Coping Inventory (PCI), pain at the tenderpoints, grip strength, the 6-min walking test (6MWT), and cycling test. Results:  In total, 64 fibromyalgia patients were screened and included. The dropout rate was 28%. A per-protocol analysis revealed significant improvement at week 6 for the Beck Depression Index, pain at the tenderpoints and the 6MWT. At week 12, the Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Index (BDI), Pain PCI, pain at the tenderpoints, grip strength, and 6MWT improved significantly. The dropout analysis showed an association in participants with a moderate BDI score at baseline. Conclusions:  A 12-week multicomponent therapy for fibromyalgia, well described and gradually applied, showed improvement in health-related outcome. According to our results, we recommend to exclude patients with a moderate-to-severe depression at onset before starting a multicomponent therapy protocol.Implications for rehabilitationMulticomponent therapy for fibromyalgia is beneficial on different health outcomes.Moderate depression at onset should be exclusion criteria for starting with multicomponent therapy in patients with fibromyalgia.This multicomponent therapy protocol is ready to be implemented at daily practice.",2020,"A per-protocol analysis revealed significant improvement at week 6 for the Beck Depression Index, pain at the tenderpoints and the 6MWT.","['64 fibromyalgia patients were screened and included', 'patients with a moderate-to-severe depression at onset before starting a multicomponent therapy protocol', 'patients with fibromyalgia', 'Participants received']","['exercise therapy and cognitive behavioural therapy', 'multicomponent therapy', 'rehabilitation Multicomponent therapy', 'graded multicomponent therapy']","['Fibromyalgia Impact Questionnaire, Tampa scale for kinesiophobia, the Beck Depression Index, the Pain Coping Inventory (PCI), pain at the tenderpoints, grip strength, the 6-min walking test (6MWT), and cycling test', 'Moderate depression', 'moderate BDI score', 'dropout rate', 'Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Index (BDI), Pain PCI, pain at the tenderpoints, grip strength, and 6MWT improved significantly', 'Beck Depression Index, pain']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",64.0,0.137972,"A per-protocol analysis revealed significant improvement at week 6 for the Beck Depression Index, pain at the tenderpoints and the 6MWT.","[{'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Ollevier', 'Affiliation': 'Healthcare Department, University College VIVES, Bruges, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vanneuville', 'Affiliation': 'Rehabilitation Centre, General Hospital AZ Alma, Sijsele-Eeklo, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Carron', 'Affiliation': 'Rehabilitation Centre, General Hospital AZ Alma, Sijsele-Eeklo, Belgium.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Baetens', 'Affiliation': 'Healthcare Department, University College VIVES, Bruges, Belgium.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Goderis', 'Affiliation': 'Rehabilitation Centre, General Hospital AZ Alma, Sijsele-Eeklo, Belgium.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gabriel', 'Affiliation': 'Rehabilitation Centre, General Hospital AZ Alma, Sijsele-Eeklo, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Van de Velde', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences, Occupational Therapy Department, Ghent University, Ghent, Belgium.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1543361']
944,31688194,Online Learning and Residents' Acquisition of Mechanical Ventilation Knowledge: Sequencing Matters.,"OBJECTIVE


Rapid advancements in medicine and changing standards in medical education require new, efficient educational strategies. We investigated whether an online intervention could increase residents' knowledge and improve knowledge retention in mechanical ventilation when compared with a clinical rotation and whether the timing of intervention had an impact on overall knowledge gains.
DESIGN


A prospective, interventional crossover study conducted from October 2015 to December 2017.
SETTING


Multicenter study conducted in 33 PICUs across eight countries.
SUBJECTS


Pediatric categorical residents rotating through the PICU for the first time. We allocated 483 residents into two arms based on rotation date to use an online intervention either before or after the clinical rotation.
INTERVENTIONS


Residents completed an online virtual mechanical ventilation simulator either before or after a 1-month clinical rotation with a 2-month period between interventions.
MEASUREMENTS AND MAIN RESULTS


Performance on case-based, multiple-choice question tests before and after each intervention was used to quantify knowledge gains and knowledge retention. Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81). Knowledge retention was greater following completion of the online intervention when compared with the clinical rotation when controlling for time (difference, 7.6%; 95% CI, 0.7-14.5; p = 0.03). When the online intervention was sequenced before (average knowledge gain, 14.6%; SD, 15.4) rather than after (average knowledge gain, 7.0%; SD, 19.1) the clinical rotation, residents had superior overall knowledge acquisition (difference, 7.6%; 95% CI, 2.01-12.97;p = 0.008).
CONCLUSIONS


Incorporating an interactive online educational intervention prior to a clinical rotation may offer a strategy to prime learners for the upcoming rotation, augmenting clinical learning in graduate medical education.",2020,"Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81).","['Multicenter study conducted in 33 PICUs across eight countries', 'Pediatric categorical residents rotating through the PICU for the first time', 'from October 2015 to December 2017']","['Mechanical Ventilation Knowledge', 'Residents completed an online virtual mechanical ventilation simulator', 'interactive online educational intervention', 'online intervention']","['superior overall knowledge acquisition', 'Initial knowledge gains', 'Knowledge retention', 'knowledge gains and knowledge retention']","[{'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",483.0,0.070347,"Initial knowledge gains in residents who completed the online intervention (average knowledge gain, 6.9%; SD, 18.2) were noninferior compared with those who completed 1 month of a clinical rotation (average knowledge gain, 6.1%; SD, 18.9; difference, 0.8%; 95% CI, -5.05 to 6.47; p = 0.81).","[{'ForeName': 'Traci A', 'Initials': 'TA', 'LastName': 'Wolbrink', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Sandrijn M', 'Initials': 'SM', 'LastName': 'van Schaik', 'Affiliation': 'Division of Pediatric Critical Care Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Turner', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Duke Children's Hospital, Durham, NC.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Keller', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Boyer', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chong', 'Affiliation': ""Division of Pediatric Critical Care, University of Chicago, Comer Children's Hospital, Chicago, IL.""}, {'ForeName': 'Jarrod', 'Initials': 'J', 'LastName': 'Cross', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, WA, Australia.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Del Castillo', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feng', 'Affiliation': 'Kapiolani Medical Center for Women and Children, Honolulu, HI.'}, {'ForeName': 'R Stanley', 'Initials': 'RS', 'LastName': 'Hum', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Ebor', 'Initials': 'E', 'LastName': 'Jacob James', 'Affiliation': 'Christian Medical College, Vellore, India.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': ""Division of Pediatric Critical Care Medicine, University of Massachusetts Children's Medical Center, Worcester, MA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kandil', 'Affiliation': 'Department of Pediatrics, Critical Care Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kneyber', 'Affiliation': ""Beatrix Children's Hospital, University Medical Center Groninger, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Rameshkumar', 'Affiliation': 'Division of Pediatric Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': ""Division of Critical Care Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Jayashree', 'Affiliation': 'Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Olivero', 'Affiliation': ""Helen DeVos Children's Hospital, Grand Rapids, MI.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Oberender', 'Affiliation': ""Pediatric Critical Care Medicine, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Rahul S', 'Initials': 'RS', 'LastName': 'Panesar', 'Affiliation': ""Stony Brook Children's Hospital, Stony Brook, NY.""}, {'ForeName': 'Puneet A', 'Initials': 'PA', 'LastName': 'Pooni', 'Affiliation': 'Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Rehder', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Duke Children's Hospital, Durham, NC.""}, {'ForeName': 'Shuba', 'Initials': 'S', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Pediatrics, Sri Ramachandra Medical College and Research Institute, Porur, Chennai, India.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Scheffler', 'Affiliation': ""Hasbro Children's Hospital, Providence, RI.""}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Sharara-Chami', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Siems', 'Affiliation': ""Division of Critical Care Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Rajakumar', 'Initials': 'R', 'LastName': 'Padur Sivaraman', 'Affiliation': ""Hasbro Children's Hospital, Providence, RI.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tegtmeyer', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Valentine', 'Affiliation': ""Division of Pediatric Critical Care Medicine, University of Massachusetts Children's Medical Center, Worcester, MA.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Villois', 'Affiliation': 'Garrahan Hospital, Buenas Aires, Argentina.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'von Saint Andre-von Arnim', 'Affiliation': ""Division of Pediatric Critical Care, Department of Pediatrics, Seattle Children's and University of Washington, Seattle, WA.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dede', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Burns', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004071']
945,30146344,Randomized study of the safety and pharmacodynamics of inhaled interleukin-13 monoclonal antibody fragment VR942.,"BACKGROUND


Interleukin-13 (IL-13) is a key mediator of T-helper-cell-type-2 (Th-2)-driven asthma, the inhibition of which may improve treatment outcomes. We examined the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of VR942, a dry-powder formulation containing CDP7766, a high-affinity anti-human-IL-13 antigen-binding antibody fragment being developed for the treatment of asthma.
METHODS


We conducted a phase 1, randomized, double-blind, placebo-controlled, ascending-dose study at Hammersmith Medicines Research, London, UK, which is now complete. Healthy adults aged 18-50 years (n = 40) were randomized 3:1 to a single inhaled dose of VR942 0.5, 1.0, 5.0, 10, or 20 mg, or placebo. Adults aged 18-50 years who were diagnosed with asthma for ≥6 months before screening, and had forced expiratory volume in 1 s (FEV 1 ) and forced vital capacity (FVC) values ≥70% of the predicted values at screening (n = 45), were randomized to once-daily inhaled VR942 0.5 or 10 mg, or placebo (2:2:1), or VR942 20 mg or placebo (3:2), for 10 days. All participants were randomized to receive VR942 or placebo based on a randomization list prepared by an independent HMR statistician using SAS® software (SAS Institute, Cary, NC). The primary outcome was safety and tolerability of VR942 (safety population, defined as all who received at least one dose of VR942 or placebo). This study is listed on ClinicalTrials.gov (NCT02473939).
FINDINGS


In the VR942 and placebo groups, treatment-emergent adverse events (TEAEs) were reported in 10/30 (33%) and 0/10 (0%) healthy participants, and in 16/29 (55%) and 9/16 (56%) participants with asthma, respectively. Mild intermittent wheezing occurred in 7 participants (VR942 20 mg, n = 4; corresponding placebo, n = 3), resolving spontaneously within 1 h. All TEAEs were mild or moderate; there were no deaths, serious adverse events, or clinically significant changes in vital signs, electrocardiograms, or laboratory parameters. There was no clinically significant immunogenicity, with only one participant with asthma considered positive for treatment-related immunogenicity for CDP7766.
INTERPRETATION


This study, considered to be the only example of a dry powder anti-IL-13 fragment antibody being administered via inhalation, demonstrated that single and repeat doses were well tolerated over a period of up to 10 days in duration. Rapid and durable inhibition of fractional exhaled nitric oxide (FeNO) (secondary outcome) provided evidence of pharmacological engagement with the IL-13 target in the airways of participants diagnosed with mild asthma. These data, together with the numerical improvements observed for predose FEV 1 , justify further clinical evaluation of VR942 in a broader population of patients with asthma, and continue to support the development of an inhaled anti-IL-13 antibody fragment as a potential future treatment that is alternative to monoclonal antibodies delivered via the parenteral route.
FUNDING


Study funding and funding for the medical writing and editorial support for preparation of the manuscript were split equally between the two study co-funders (Vectura Ltd and UCB Pharma).",2018,"All TEAEs were mild or moderate; there were no deaths, serious adverse events, or clinically significant changes in vital signs, electrocardiograms, or laboratory parameters.","['Adults aged 18-50 years who were diagnosed with asthma for ≥6 months before screening, and had forced expiratory volume in 1 s (FEV 1 ) and forced vital capacity (FVC) values ≥70% of the predicted values at screening (n = 45', 'participants diagnosed with mild asthma', 'Healthy adults aged 18-50 years (n = 40']","['placebo', 'VR942 or placebo', 'inhaled interleukin-13 monoclonal antibody fragment VR942', 'inhaled VR942 0.5 or 10 mg, or placebo', 'VR942 20 mg or placebo']","['safety and tolerability of VR942 (safety population', 'safety, pharmacokinetics, pharmacodynamics, and immunogenicity of VR942', 'Mild intermittent wheezing', 'deaths, serious adverse events', 'vital signs, electrocardiograms, or laboratory parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.544355,"All TEAEs were mild or moderate; there were no deaths, serious adverse events, or clinically significant changes in vital signs, electrocardiograms, or laboratory parameters.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burgess', 'Affiliation': 'Vectura Ltd, 1 Prospect West, Chippenham, Wiltshire SN14 6FH, UK. Electronic address: gary.burgess@vectura.com.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Boyce', 'Affiliation': 'Hammersmith Medicines Research, Cumberland Avenue, London NW10 7EW, UK. Electronic address: mboyce@hmrlondon.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Margaret.Jones@ucb.com.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Larsson', 'Affiliation': 'TranScrip LLP, 400 Thames Valley Park Drive, Reading, Berkshire RG6 1PT, UK. Electronic address: lars.larsson@transcrip-partners.com.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Main', 'Affiliation': 'Vectura Ltd, 1 Prospect West, Chippenham, Wiltshire SN14 6FH, UK.'}, {'ForeName': 'Frazer', 'Initials': 'F', 'LastName': 'Morgan', 'Affiliation': 'Vectura Ltd, 1 Prospect West, Chippenham, Wiltshire SN14 6FH, UK. Electronic address: frazer.morgan@vectura.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phillips', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Peter.Phillips@ucb.com.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Scrimgeour', 'Affiliation': 'Vectura Ltd, 1 Prospect West, Chippenham, Wiltshire SN14 6FH, UK. Electronic address: alison.scrimgeour@vectura.com.'}, {'ForeName': 'Foteini', 'Initials': 'F', 'LastName': 'Strimenopoulou', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Foteini.Strimenopoulou@ucb.com.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Vajjah', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Pavan.Vajjah@ucb.com.'}, {'ForeName': 'Miren', 'Initials': 'M', 'LastName': 'Zamacona', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Miren.Zamacona@ucb.com.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Palframan', 'Affiliation': 'UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Roger.Palframan@ucb.com.'}]",EBioMedicine,['10.1016/j.ebiom.2018.07.035']
946,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE


Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN


A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING


A tertiary health care referral center.
SUBJECTS AND METHODS


The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS


Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION


Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Nassar', 'Initials': 'N', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
947,32408166,Using immersive virtual reality to modify body image.,"We tested the efficacy of a training programme, delivered in virtual reality (VR), to modify the perceptual boundary between what participants classify as a fat versus a thin body. Three cohorts of 20 female volunteers with high body image concerns were recruited to two intervention groups and one control group. All participants completed a 4-day training programme in VR where they categorised a series of 3D models as either thin or fat; one intervention group was presented with the stimuli briefly, while the other group had no time limits imposed. Both intervention groups were given inflationary feedback to shift their categorisations of the stimulus models towards higher BMIs. Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14. Unlimited stimulus presentation times were associated with a larger training effect. Furthermore, both intervention groups experienced statistically significant reductions in their concerns about their own body shape, weight and eating habits. However, only in the group with longer stimulus presentation times were these reductions consistent with a clinically meaningful effect. These findings suggest that manipulating categorical perception in VR might provide a complementary addition to existing treatments for eating disorders.",2020,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.",['20 female volunteers with high body image concerns'],"['training programme, delivered in virtual reality (VR', '4-day training programme']","['body shape, weight and eating habits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",20.0,0.01014,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.","[{'ForeName': 'Kamila R', 'Initials': 'KR', 'LastName': 'Irvine', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK. Electronic address: kirvine@lincoln.ac.uk.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Irvine', 'Affiliation': 'Virtual Research Innovations Ltd., UK; School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Maalin', 'Affiliation': 'School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Kristofor', 'Initials': 'K', 'LastName': 'McCarty', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Katri K', 'Initials': 'KK', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Tovée', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Piers L', 'Initials': 'PL', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}]",Body image,['10.1016/j.bodyim.2020.03.007']
948,30716769,Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial.,"Background


The use of compounded topical pain creams has increased dramatically, yet their effectiveness has not been well evaluated.
Objective


To determine the efficacy of compounded creams for chronic pain.
Design


Randomized controlled trials of 3 interventions. (ClinicalTrials.gov: NCT02497066).
Setting


Military treatment facility.
Participants


399 patients with localized pain classified by each patient's treating physician as neuropathic (n = 133), nociceptive (n = 133), or mixed (n = 133).
Intervention


Pain creams compounded for neuropathic pain (ketamine, gabapentin, clonidine, and lidocaine), nociceptive pain (ketoprofen, baclofen, cyclobenzaprine, and lidocaine), or mixed pain (ketamine, gabapentin, diclofenac, baclofen, cyclobenzaprine, and lidocaine), or placebo.
Measurements


The primary outcome measure was average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed through 3 months.
Results


For the primary outcome, no differences were found in the mean reduction in average pain scores between the treatment and control groups for patients with neuropathic pain (-0.1 points [95% CI, -0.8 to 0.5 points]), nociceptive pain (-0.3 points [CI, -0.9 to 0.2 points]), or mixed pain (-0.3 points [CI, -0.9 to 0.2 points]), or for all patients (-0.3 points [CI, -0.6 to 0.1 points]). At 1 month, 72 participants (36%) in the treatment groups and 54 (28%) in the control group had a positive outcome (risk difference, 8% [CI, -1% to 17%]).
Limitations


Generalizability is limited by heterogeneity among pain conditions and formulations of the study interventions. Randomized follow-up was only 1 month.
Conclusion


Compounded pain creams were not better than placebo creams, and their higher costs compared with approved compounds should curtail routine use.
Primary Funding Source


Centers for Rehabilitation Sciences Research, Defense Health Agency, U.S. Department of Defense.",2019,", no differences were found in the mean reduction in average pain scores between the treatment and control groups for patients with neuropathic pain (-0.1 points [95% CI, -0.8 to 0.5 points]), nociceptive pain (-0.3 points [CI, -0.9 to 0.2 points]), or mixed pain (-0.3 points [CI, -0.9 to 0.2 points]), or for all patients (-0.3 points [CI, -0.6 to 0.1 points]).","['Localized Chronic Pain', ""Participants\n\n\n399 patients with localized pain classified by each patient's treating physician as neuropathic (n\xa0= 133), nociceptive (n\xa0= 133), or mixed (n\xa0= 133""]","['Topical Pain Creams', 'ketamine, gabapentin, clonidine, and lidocaine), nociceptive pain (ketoprofen, baclofen, cyclobenzaprine, and lidocaine), or mixed pain (ketamine, gabapentin, diclofenac, baclofen, cyclobenzaprine, and lidocaine), or placebo']","['pain score', 'nociceptive pain', 'average pain score', 'mixed pain', 'neuropathic pain', 'Short Form-36 Health Survey scores, satisfaction, and categorical response', 'average pain scores']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C3178766', 'cui_str': 'Nociceptive Pain'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0056732', 'cui_str': 'cyclobenzaprine'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3178766', 'cui_str': 'Nociceptive Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",399.0,0.458534,", no differences were found in the mean reduction in average pain scores between the treatment and control groups for patients with neuropathic pain (-0.1 points [95% CI, -0.8 to 0.5 points]), nociceptive pain (-0.3 points [CI, -0.9 to 0.2 points]), or mixed pain (-0.3 points [CI, -0.9 to 0.2 points]), or for all patients (-0.3 points [CI, -0.6 to 0.1 points]).","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Brutcher', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland (R.E.B., C.K., P.M.).'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kurihara', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland (R.E.B., C.K., P.M.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Bicket', 'Affiliation': 'Johns Hopkins Medicine and Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (M.C.B.).'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Moussavian-Yousefi', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland (R.E.B., C.K., P.M.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Reece', 'Affiliation': 'Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland (D.E.R., S.R.G., D.E.J.).'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Solomon', 'Affiliation': 'Walter Reed National Military Medical Center, Johns Hopkins Medicine, Baltimore, Maryland (L.M.S.).'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Griffith', 'Affiliation': 'Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland (D.E.R., S.R.G., D.E.J.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Jamison', 'Affiliation': 'Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland (D.E.R., S.R.G., D.E.J.).'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Cohen', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland, and Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland (S.P.C.).'}]",Annals of internal medicine,['10.7326/M18-2736']
949,31606939,Clinical evaluation of interrupted versus continuous narrowband ultraviolet B phototherapy in nonsegmental vitiligo treatment: A prospective randomized comparative study.,"Phototherapy is the pillar of vitiligo treatment. One of its main obstacles is noncompliance. It was noticed that patients continue to repigment even after stopping sessions, so the idea of interrupted phototherapy emerged. To evaluate the effectiveness of interrupted versus continuous NB-UVB in nonsegmental vitiligo treatment. A prospective randomized comparative study of 23 patients with bilateral, nonsegmental vitiligo with no age or sex limits. All patients were treated with NB-UVB phototherapy for 1 month, after which one side of the body received continuous therapy (Side A) and the other received an interrupted course (Side B) for a total of 6 months. Two more groups of 10 patients were enrolled to exclude the systemic effect of NB-UVB. One group received continuous NB-UVB treatment, and the other received interrupted courses for 6 months. Evaluation of the results was performed clinically, by digital photography, planimetry and Vitiligo Area Scoring Index (VASI) prior to and 3 and 6 months after treatment. There was a significant clinical improvement in Group 1 compared to baseline (p < .05). However, there was no significant difference between the sides with regards to the clinical evaluation, point counting, and VASI scores (p > .05). When comparing the other two groups, there was a significant clinical improvement in each group after 6 months of treatment compared to baseline (p < .05), while there was no significant difference between them (p > .05). The current study suggests that interrupted NB-UVB phototherapy is a good alternative to continuous treatment with improved patient compliance, fewer side effects, and a lower cost of treatment.",2019,"However, there was no significant difference between the sides with regards to the clinical evaluation, point counting and VASI scores (p > 0.05).","['23 patients with bilateral, non-segmental vitiligo with no age or sex limits', 'non-segmental vitiligo treatment']","['Phototherapy', 'continuous NB-UVB', 'continuous narrowband ultraviolet B phototherapy', 'NB-UVB phototherapy', 'interrupted NB-UVB phototherapy']","['systemic effect of NB-UVB', 'clinical evaluation, point counting and VASI scores', 'digital photography, planimetry and Vitiligo Area Scoring Index (VASI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy (procedure)'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy (procedure)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0293801,"However, there was no significant difference between the sides with regards to the clinical evaluation, point counting and VASI scores (p > 0.05).","[{'ForeName': 'Tag S', 'Initials': 'TS', 'LastName': 'Anbar', 'Affiliation': 'Dermatology Department, Minia University, Minia, Egypt.'}, {'ForeName': 'Sahar S', 'Initials': 'SS', 'LastName': 'Mohammed', 'Affiliation': 'Dermatology Department, Minia University, Minia, Egypt.'}, {'ForeName': 'Doaa M', 'Initials': 'DM', 'LastName': 'Mohamed', 'Affiliation': 'Dermatology Department, Minia University, Minia, Egypt.'}, {'ForeName': 'Amal T', 'Initials': 'AT', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Dermatology Department, Minia University, Minia, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13117']
950,31594253,Long-Term Efficacy of Safinamide on Symptoms Severity and Quality of Life in Fluctuating Parkinson's Disease Patients.,"BACKGROUND


Parkinson's disease (PD) is characterized by a wide range of motor and non-motor symptoms. Levodopa is still the most effective drug; however, its long-term use is associated with motor complications which may deteriorate patient's quality of life. Safinamide is a unique treatment modulating both dopaminergic and glutamatergic systems. Previous results from two six months, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients.
OBJECTIVE


To investigate the effects of safinamide 100 mg/day over two-year treatment on PD symptoms severity and quality of life, using data from the study 018.
METHODS


Data from 352 patients were analyzed to evaluate the effects of safinamide on OFF time and ON time (with no or non-troublesome dyskinesia) in the overall population and in subgroups of patients (receiving levodopa monotherapy or with other anti-Parkinson therapies), and the effects of safinamide on motor symptoms/clinical fluctuations (by means of UPDRS III and IV) and on health-related quality of life (using UPDRS II and PDQ-39 summary index score).
RESULTS


Safinamide, administered as add-on to standard therapy in fluctuating PD patients, significantly improved motor symptoms and clinical fluctuations in the overall population and in some subgroups of patients. Additionally, safinamide improved quality of life and activities of daily living, maintaining the efficacy in the long-term.
CONCLUSIONS


The findings of these analyses suggest that safinamide may be considered an appropriate adjunct therapy in patient not sufficiently controlled. Further investigations are desirable to confirm these results in usual care setting.",2020,"RESULTS


Safinamide, administered as add-on to standard therapy in fluctuating PD patients, significantly improved motor symptoms and clinical fluctuations in the overall population and in some subgroups of patients.","[""Parkinson's disease (PD"", 'Data from 352 patients', ""Fluctuating Parkinson's Disease Patients""]","['Safinamide', 'levodopa monotherapy or with other anti-Parkinson therapies', 'safinamide', 'placebo', 'Levodopa']","['PD symptoms severity and quality of life', 'motor symptoms/clinical fluctuations (by means of UPDRS III and IV) and on health-related quality of life (using UPDRS II and PDQ-39 summary index score', 'quality of life and activities of daily living, maintaining the efficacy', 'OFF time and ON time (with no or non-troublesome dyskinesia', 'Symptoms Severity and Quality of Life', 'motor functions and quality of life', 'motor symptoms and clinical fluctuations']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",352.0,0.0742534,"RESULTS


Safinamide, administered as add-on to standard therapy in fluctuating PD patients, significantly improved motor symptoms and clinical fluctuations in the overall population and in some subgroups of patients.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cattaneo', 'Affiliation': 'Medical Department, Zambon SpA, Bresso, Italy.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Jost', 'Affiliation': 'Parkinson-Klinik Ortenau, Wolfach, Germany.'}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Bonizzoni', 'Affiliation': 'Department of Clinical Science and Community, Section of Medical Statistics and Biometry ""GA Maccacaro"", University of Milan, Milan, Italy.'}]",Journal of Parkinson's disease,['10.3233/JPD-191765']
951,31685037,Whole-grain consumption and its effects on hepatic steatosis and liver enzymes in patients with non-alcoholic fatty liver disease: a randomised controlled clinical trial.,"Non-alcoholic fatty liver disease (NAFLD) is a considerable challenge to public health across the globe. Whole grain is highly recommended as an inseparable part of a healthy diet and has been proposed as an effective way to manage NAFLD. The objective in the present study was to evaluate the effects of whole-grain consumption on hepatic steatosis and liver enzymes as primary outcomes in patients with NAFLD. Over the 12 weeks of this open-label, randomised controlled clinical trial, 112 patients (mean age 43 (sd 8·7) years; BMI 32·2 (sd 4·3) kg/m2) were randomly assigned to two groups to receive dietary advice, either to obtain at least half of their cereal servings each day from whole-grain foods or from usual cereals. By the end of the study, the grades of NAFLD showed a significant decrease in the intervention group (P < 0·001). In addition, a significant reduction in serum concentration of alanine aminotransferase (P < 0·001), aspartate aminotransferase (P < 0·001), γ-glutamyltransferase (P = 0·009), systolic blood pressure (P = 0·004) and diastolic blood pressure (P = 0·008) was observed in the intervention group compared with the control group. After adjusting, however, no significant differences were found between the two groups in terms of lipid profile, glycaemic status and anthropometric measurements. Overall, our study demonstrated that consumption of whole grains for 12 weeks had beneficial effects on hepatic steatosis and liver enzymes concentrations in patients with NAFLD.",2020,"In addition, a significant reduction in serum concentration of alanine aminotransferase (P < 0.001), aspartate aminotransferase (P < 0.001), γ-glutamyltransferase (P = 0.009), systolic blood pressure (P = 0.004) and diastolic blood pressure (P = 0.008) were observed in the intervention group compared to the control group.","['Nonalcoholic fatty liver disease (NAFLD', 'Patients with Nonalcoholic Fatty Liver Disease', 'patients with NAFLD', '112 patients [mean age: 43± 8.7 y; body mass index (BMI) (kg/m2): 32.2 ± 4.3']","['whole grain consumption', 'dietary advice; either to obtain at least half of their cereal servings each day from whole-grain foods or from usual cereals']","['hepatic steatosis and liver enzymes concentrations', 'systolic blood pressure', 'γ-glutamyltransferase', 'diastolic blood pressure', 'lipid profile, glycemic status, and anthropometric measurements', 'hepatic steatosis and liver enzymes', 'Hepatic Steatosis and Liver Enzymes', 'serum concentration of alanine aminotransferase', 'aspartate aminotransferase']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]",112.0,0.0795983,"In addition, a significant reduction in serum concentration of alanine aminotransferase (P < 0.001), aspartate aminotransferase (P < 0.001), γ-glutamyltransferase (P = 0.009), systolic blood pressure (P = 0.004) and diastolic blood pressure (P = 0.008) were observed in the intervention group compared to the control group.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Dorosti', 'Affiliation': 'Student Research Committee, Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jafary Heidarloo', 'Affiliation': 'Gastroenterology and Hepatology subdivision of Internal Medicine, Imam Khomeini Hospital, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Farnush', 'Initials': 'F', 'LastName': 'Bakhshimoghaddam', 'Affiliation': 'Student Research Committee, Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}]",The British journal of nutrition,['10.1017/S0007114519002769']
952,30656507,Usefulness of combining clinical and biochemical parameters for prediction of postoperative pulmonary complications after lung resection surgery.,"Early detection of patients with a high risk of postoperative pulmonary complications (PPCs) could improve postoperative strategies. We investigated the role of monitoring systemic and lung inflammatory biomarkers during surgery and the early postoperative period to detect patients at high risk of PPCs after lung resection surgery (LRS). This is a substudy of a randomized control trial on the inflammatory effects of anaesthetic drugs during LRS. We classified patients into two groups, depending on whether or not they developed PPCs. We constructed three multivariate logistic regression models to analyse the power of the biomarkers to predict PPCs. Model 1 only included the usual clinical variables; Model 2 included lung and systemic inflammatory biomarkers; and Model 3 combined Models 1 and 2. Comparisons between mathematical models were based on the area under the receiver operating characteristic curve (AUROC) and tests of integrated discrimination improvement (IDI). Statistical significance was set at p < 0.05. PPCs were detected in 37 (21.3%) patients during admission. The AUROC for Models 1, 2, and 3 was 0.79 (95% CI 0.71-0.87), 0.80 (95% CI 0.72-0.88), and 0.93 (95% CI 0.88-0.97), respectively. Comparison of the AUROC between Models 1 and 2 did not reveal statistically significant values (p = 0.79). However, Model 3 was superior to Model 1 (p < 0.001). Model 3 had had an IDI of 0.29 (p < 0.001) and a net reclassification index of 0.28 (p = 0.007). A mathematical model combining inflammation biomarkers with clinical variables predicts PPCs after LRS better than a model that includes only clinical data. Clinical registration number Clinical Trial Registration NCT02168751; EudraCT 2011-002294-29.",2019,Comparison of the AUROC between Models 1 and 2 did not reveal statistically significant values (p = 0.79).,"['patients with a high risk of postoperative pulmonary complications (PPCs', 'lung resection surgery', 'patients at high risk of PPCs after lung resection surgery (LRS']",[],['PPCs'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],[],,0.119355,Comparison of the AUROC between Models 1 and 2 did not reveal statistically significant values (p = 0.79).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garutti', 'Affiliation': 'Department Anaesthesia, Hospital General Marañón (HGUGM), St/ Doctor Esquerdo 46, 28009, Madrid, Spain. ngaruttimartinez@yahoo.es.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'De la Gala', 'Affiliation': 'Department Anaesthesia, Hospital General Marañón (HGUGM), St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Piñeiro', 'Affiliation': 'Department Anaesthesia, Hospital General Marañón (HGUGM), St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rancan', 'Affiliation': 'Department Biochemistry, School of Medicine, Universidad Complutense de Madrid (UCM), St/ Doctor Severo Ochoa, 7, 28040, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vara', 'Affiliation': 'Department Biochemistry, School of Medicine, Universidad Complutense de Madrid (UCM), St/ Doctor Severo Ochoa, 7, 28040, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Department Anaesthesia, Hospital General Marañón (HGUGM), St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Puente-Maestu', 'Affiliation': 'Department Pneumology, HGUGM, Madrid St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Bellón', 'Affiliation': 'Department Statistics, HGUGM Biomedical Research Foundation, St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Simón', 'Affiliation': 'Department Thoracic Surgery, HGUGM, Madrid St/ Doctor Esquerdo 46, 28009, Madrid, Spain.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00257-4']
953,31664751,Randomized control trial outcomes of tranexamic acid combination serum as a depigmenting agent for the use in healthy individuals.,"To compare the effectiveness of tranexamic acid (TA) combination serum with hydroquinone, the gold standard in whitening agents for healthy populations. This was a three-arm randomized controlled trial. The subjects were divided into three groups: the first group received 3% TA combination serum (3% TA, 4% galactomyces ferment filtrate, 2% niacinamide, and 4% alpha arbutin), the second group received 2% TA combination serum, and the third group received 4% hydroquinone. One milliliter of each serum was applied on three holes: Hole A, which was located 4 cm from the left cubital fossa, Hole B, which was located 4 cm from the first hole, and Hole C, which was located 4 cm from the right cubital fossa. The skin brightness and pigmentation intensity were evaluated each week for 4 weeks using a chromameter. A total of 44 subjects were recruited for this study. All groups showed a significant improvement in skin brightness and pigmentation intensity after 4 weeks (p < .001). There were no differences between the treatment groups and hydroquinone (p > .05). TA serum (2 and 3%) combined with 4% galactomyces ferment filtrate, niacinamide, and alpha arbutin is an effective depigmenting agent.",2019,All groups showed a significant improvement in skin brightness and pigmentation intensity after four weeks (p<0.001).,"['healthy individuals', 'healthy populations', 'A total of 44 subjects']","['tranexamic acid (TA) combination serum (3% TA, 4% galactomyces ferment filtrate, 2% niacinamide and 4% alpha arbutin), the second group received 2 % TA combination serum, and the third group received 4% hydroquinone', 'tranexamic acid combination serum with hydroquinone', 'hydroquinone', 'tranexamic acid combination serum']",['skin brightness and pigmentation intensity'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1001415', 'cui_str': 'Genus Galactomyces'}, {'cui': 'C0028027', 'cui_str': 'nicotinamide'}, {'cui': 'C3528818', 'cui_str': 'alpha-arbutin'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020307', 'cui_str': 'Quinols'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",44.0,0.0298331,All groups showed a significant improvement in skin brightness and pigmentation intensity after four weeks (p<0.001).,"[{'ForeName': 'Anis I', 'Initials': 'AI', 'LastName': 'Anwar', 'Affiliation': 'Department of Dermatology and Venereology, Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Siswanto', 'Initials': 'S', 'LastName': 'Wahab', 'Affiliation': 'Department of Dermatology and Venereology, Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Widya', 'Initials': 'W', 'LastName': 'Widita', 'Affiliation': 'Department of Dermatology and Venereology, Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Airin R', 'Initials': 'AR', 'LastName': 'Nurdin', 'Affiliation': 'Department of Dermatology and Venereology, Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Suci', 'Initials': 'S', 'LastName': 'Budhiani', 'Affiliation': 'Department of Dermatology and Venereology, Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Arifin', 'Initials': 'A', 'LastName': 'Seweng', 'Affiliation': 'Medical Faculty, Hasanuddin University, Makassar, Indonesia.'}]",Dermatologic therapy,['10.1111/dth.13146']
954,30409085,A Mediterranean diet supplemented with dairy foods improves mood and processing speed in an Australian sample: results from the MedDairy randomized controlled trial.,"Background  The Mediterranean diet has been linked to improved cognitive function and reduced risk of dementia. However, a traditional Mediterranean diet may not meet calcium requirements for older non-Mediterranean populations, which could limit long-term sustainability in Western countries. The current study therefore aimed to determine the cognitive and psychological effects of a Mediterranean diet with adequate calcium for an ageing Australian population.  Method:  A randomized controlled cross-over design trial compared a Mediterranean diet with 3-4 daily serves of dairy food (MedDairy) with a low-fat (LF) control diet. Forty-one participants aged ≥45 years with systolic blood pressure ≥120 mm Hg and at least two other risk factors for cardiovascular disease completed each dietary intervention for 8 weeks, with an 8-week washout period separating interventions. Attention, processing speed, memory and planning were assessed at the start and end of each intervention using the Cambridge Automated Neuropsychological Test Battery. Mood and health-related quality of life were evaluated using the Profile of Mood States (POMS) and Short-Form Health Survey (SF-36). Dementia risk was also measured using the Framingham Vascular Risk and CAIDE scores.  Results  Significant improvements were observed for processing speed ( P  = .04), Total Mood Disturbance ( P  = .01), Tension ( P  = .03), Depression ( P  = .03), Anger ( P  = .02), and Confusion ( P  = .004) following the MedDairy intervention. No significant effects were found for attention, memory and planning, or measures of dementia risk.  Conclusion  Our study provides evidence that a Mediterranean diet supplemented with dairy foods may benefit cognitive function and psychological well-being in an ageing population at risk of dementia.",2020,"RESULTS


Significant improvements were observed for processing speed (P = .04), Total Mood Disturbance (P = .01), Tension (P = .03), Depression (P = .03), Anger (P = .02), and Confusion (P = .004) following the MedDairy intervention.","['Australian sample', 'Forty-one participants aged ≥45 years with systolic blood pressure ≥120\u2005mm\u2005Hg and at least two other risk factors for cardiovascular disease completed each']","['Mediterranean diet supplemented with dairy foods', 'Mediterranean diet with 3-4 daily serves of dairy food (MedDairy) with a low-fat (LF) control diet', 'Mediterranean diet with adequate calcium', 'dietary intervention']","['attention, memory and planning, or measures of dementia risk', 'Total Mood Disturbance', 'Profile of Mood States (POMS) and Short-Form Health Survey (SF-36', 'mood and processing speed', 'Depression', 'Attention, processing speed, memory and planning', 'Dementia risk', 'processing speed', 'Tension', 'Mood and health-related quality of life', 'Framingham Vascular Risk and CAIDE scores']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0452286', 'cui_str': 'Fat controlled diet (finding)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",41.0,0.069291,"RESULTS


Significant improvements were observed for processing speed (P = .04), Total Mood Disturbance (P = .01), Tension (P = .03), Depression (P = .03), Anger (P = .02), and Confusion (P = .004) following the MedDairy intervention.","[{'ForeName': 'Alexandra T', 'Initials': 'AT', 'LastName': 'Wade', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide 5001, South Australia.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide 5001, South Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Dyer', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, GPO Box 2471, Adelaide 5001, South Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, GPO Box 2100 Adelaide 5001, South Australia.'}, {'ForeName': 'Hannah A D', 'Initials': 'HAD', 'LastName': 'Keage', 'Affiliation': 'Cognitive Ageing and Impairment Neurosciences, School of Psychology, Social Work and Social Policy, University of South Australian, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Murphy', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, GPO Box 2471, Adelaide 5001, South Australia.'}]",Nutritional neuroscience,['10.1080/1028415X.2018.1543148']
955,30658546,Economic evaluation of stepped care for the management of childhood anxiety disorders: Results from a randomised trial.,"BACKGROUND


Stepped care has been promoted for the management of mental disorders; however, there is no empirical evidence to support the cost-effectiveness of this approach for the treatment of anxiety disorders in youth.
METHOD


This economic evaluation was conducted within a randomised controlled trial comparing stepped care to a validated, manualised treatment in 281 young people, aged 7-17, with a diagnosed anxiety disorder. Intervention costs were determined from therapist records. Administrative data on medication and medical service use were used to determine additional health care costs during the study period. Parents also completed a resource use questionnaire to collect medications, services not captured in administrative data and parental lost productivity. Outcomes included participant-completed quality of life, Child Health Utility - nine-dimension and parent-completed Assessment of Quality of Life - eight-dimension to calculate quality-adjusted life years. Mean costs and quality-adjusted life years were compared between groups at 12-month follow-up.
RESULTS


Intervention delivery costs were significantly less for stepped care from the societal perspective (mean difference -$198, 95% confidence interval -$353 to -$19). Total combined costs were less for stepped care from both societal (-$1334, 95% confidence interval -$2386 to $510) and health sector (-$563, 95% confidence interval -$1353 to $643) perspectives but did not differ significantly from the manualised treatment. Youth and parental quality-adjusted life years were not significantly different between groups. Sensitivity analysis indicated that the results were robust.
CONCLUSION


For youth with anxiety, this three-step model provided comparable outcomes and total health sector costs to a validated face-to-face programme. However, it was less costly to deliver from a societal perspective, making it an attractive option for some parents. Future economic evaluations comparing various models of stepped care to treatment as usual are recommended.",2019,"Total combined costs were less for stepped care from both societal (-$1334, 95% confidence interval -$2386 to $510) and health sector (-$563, 95% confidence interval -$1353 to $643) perspectives but did not differ significantly from the manualised treatment.","['childhood anxiety disorders', '281 young people, aged 7-17, with a diagnosed anxiety disorder', 'youth with anxiety']",['stepped care'],"['Youth and parental quality-adjusted life years', 'Total combined costs', 'Mean costs and quality-adjusted life years', 'health sector', 'total health sector costs', 'participant-completed quality of life, Child Health Utility - nine-dimension and parent-completed Assessment of Quality of Life - eight-dimension to calculate quality-adjusted life years']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]",281.0,0.129118,"Total combined costs were less for stepped care from both societal (-$1334, 95% confidence interval -$2386 to $510) and health sector (-$563, 95% confidence interval -$1353 to $643) perspectives but did not differ significantly from the manualised treatment.","[{'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Chatterton', 'Affiliation': '1 Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': '2 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Catchpool', 'Affiliation': '3 Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Carlton, VIC, Australia.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Lyneham', 'Affiliation': '2 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Wuthrich', 'Affiliation': '2 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': '2 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': '2 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': '1 Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867418823272']
956,31678062,"Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial.","BACKGROUND


For patients with obesity and type 2 diabetes, weight loss improves insulin sensitivity and β-cell function, and can induce remission of diabetes. The comparative efficacy of various bariatric procedures for the remission of type 2 diabetes has not been fully elucidated. We aimed to compare the effects of the two most common bariatric procedures, gastric bypass and sleeve gastrectomy, on remission of diabetes and β-cell function.
METHODS


We conducted a single-centre, triple-blind, randomised trial at Vestfold Hospital Trust (Tønsberg, Norway), in which patients (aged ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) to receive gastric bypass or sleeve gastrectomy (the Oseberg study). Randomisation was performed with a computerised random number generator and a block size of 10. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed with sealed opaque envelopes. Surgeons used identical skin incisions during both surgeries and were not involved in patient follow-up. The primary clinical outcome was the proportion of participants with complete remission of type 2 diabetes (HbA 1c  of ≤6·0% [42 mmol/mol] without the use of glucose-lowering medication) at 1 year after surgery. The primary physiological outcome was disposition index (a measure of β-cell function) at 1 year after surgery, as assessed by an intravenous glucose tolerance test. Primary outcomes were analysed in the intention-to-treat and per-protocol populations. This trial is ongoing and closed to recruitment, and is registered with ClinicalTrials.gov, NCT01778738.
FINDINGS


Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes were assessed for eligibility. 109 patients were enrolled and randomly assigned to gastric bypass (n=54) or sleeve gastrectomy (n=55). 107 (98%) of 109 patients completed 1-year follow-up, with one patient in each group withdrawing after surgery (per-protocol population). In the intention-to-treat population, diabetes remission rates were higher in the gastric bypass group than in the sleeve gastrectomy group (risk difference 27% [95% CI 10 to 44]; relative risk [RR] 1·57 [1·14 to 2·16], p=0·0054); results were similar in the per-protocol population (risk difference 27% [95% CI 10 to 45]; RR 1·57 [1·14 to 2·15], p=0·0036). In the intention-to-treat population, disposition index increased in both groups (between-group difference 55 [-111 to 220], p=0·52); results were similar in the per-protocol population (between-group difference 21 [-214 to 256], p=0.86). In the gastric bypass group, ten of 54 participants had early complications and 17 of 53 had late side-effects. In the sleeve gastrectomy group, eight of 55 participants had early complications and 22 of 54 had late side-effects. No deaths occurred in either group.
INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function. The use of gastric bypass as the preferred bariatric procedure for patients with obesity and type 2 diabetes could improve diabetes care and reduce related societal costs.
FUNDING


Morbid Obesity Centre, Vestfold Hospital Trust.",2019,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","['patients (aged ≥18 years) with type 2 diabetes and obesity', 'patients with obesity and type 2 diabetes', 'Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes', 'patients with type 2 diabetes (Oseberg', '109 patients']","['sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy', 'gastric bypass', 'gastric bypass or sleeve gastrectomy', 'various bariatric procedures', 'Gastric bypass versus sleeve gastrectomy']","['diabetes remission rates', 'disposition index', 'intravenous glucose tolerance test', 'disposition index (a measure of β-cell function', 'proportion of participants with complete remission of type 2 diabetes', 'early complications', 'deaths', 'intention-to-treat and per-protocol populations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance Test'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",1305.0,0.153451,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","[{'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Borgeraas', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Kåre Inge', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Department of Transplantation, Institute of Clinical Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne Løvdal', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Oslo, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Laboratory Medicine, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Njord', 'Initials': 'N', 'LastName': 'Nordstrand', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova Småstuen', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Nutrition and Management, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'New Bolton Center, School of Veterinary Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Svanevik', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Gretland Valderhaug', 'Affiliation': 'Department of Endocrinology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, University of Oslo, Norway. Electronic address: joran.hjelmeseth@siv.no.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30344-4']
957,30610516,Effects of propofol versus sevoflurane on cerebral circulation time in patients undergoing coiling for cerebral artery aneurysm: a prospective randomized crossover study.,"Many neuroendovascular treatments are supported by real-time anatomical and visual hemodynamic assessments through digital subtraction angiography (DSA). Here we used DSA in a single-center prospective randomized crossover study to assess the intracranial hemodynamics of patients undergoing coiling for cerebral aneurysm (n = 15) during sevoflurane- and propofol-based anesthesia. Color-coded DSA was used to define time to peak density of contrast medium (TTP) at several intravascular regions of interest (ROIs). Travel time at a particular ROI was defined as the TTP at the selected ROI minus TTP at baseline position on the internal carotid artery (ICA). Travel time at the jugular bulb on the anterior-posterior view was defined as the cerebral circulation time (CCT), which was divided into four segmental circulation times: ICA, middle cerebral artery (MCA), microvessel, and sinus. When bispectral index values were kept between 40 and 60, CCT (median [interquartile range]) was 10.91 (9.65-11.98) s under propofol-based anesthesia compared with 8.78 (8.32-9.45) s under sevoflurane-based anesthesia (P < 0.001). Circulation times for the ICA, MCA, and microvessel segments were longer under propofol-based anesthesia than under sevoflurane-based anesthesia (P < 0.05 for all). Our results suggest that, relative to sevoflurane, propofol decreases overall cerebral perfusion.",2019,"Circulation times for the ICA, MCA, and microvessel segments were longer under propofol-based anesthesia than under sevoflurane-based anesthesia (P < 0.05 for all).","['patients undergoing coiling for cerebral aneurysm (n\u2009=\u200915) during', 'patients undergoing coiling for cerebral artery aneurysm']","['sevoflurane- and propofol-based anesthesia', 'sevoflurane', 'propofol', 'sevoflurane, propofol', 'digital subtraction angiography (DSA']","['cerebral circulation time', 'Circulation times', 'bispectral index values', 'cerebral circulation time (CCT', 'Travel time', 'overall cerebral perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0155730', 'cui_str': 'Nonruptured cerebral aneurysm (disorder)'}, {'cui': 'C0007770', 'cui_str': 'Cerebral Arteries'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0002979', 'cui_str': 'Angiography, Digital Subtraction'}]","[{'cui': 'C0007818', 'cui_str': 'Cerebral Circulation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0245582,"Circulation times for the ICA, MCA, and microvessel segments were longer under propofol-based anesthesia than under sevoflurane-based anesthesia (P < 0.05 for all).","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Anesthesiology, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Toyama', 'Affiliation': 'Department of Critical Care and Anesthesia, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-Ku, Tokyo, 157-8535, Japan. s-toyama@suite.plala.or.jp.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Department of Endovascular Surgery, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Karakama', 'Affiliation': 'Department of Endovascular Surgery, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Yoshino', 'Affiliation': 'Department of Endovascular Surgery, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Clinical Research Center, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nemoto', 'Affiliation': 'Department of Endovascular Surgery, Graduate School of Medicine and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-018-00251-2']
958,31597151,Aerobic Exercise Training and Nontraditional Cardiovascular Risk Factors in Hemodialysis Patients: Results from a Prospective Randomized Trial.,"INTRODUCTION


Chronic kidney disease (CKD) patients have a high incidence of cardiovascular diseases (CVD) which increases their morbidity and mortality. A sedentary lifestyle in CKD is directly linked to the onset of CVD. Physical activity can bring beneficial effects to CKD patients.
AIMS


The aim of this study was assess the impact of aerobic training on nontraditional cardiovascular risk factors in CKD patients on hemodialysis.
MATERIALS AND METHODS


This is a prospective, controlled, and randomized clinical trial with analysis of intention to treat. Thirty patients underwent an exercise treadmill test, an arterial stiffness evaluation, echocardiography and analysis of endothelial reactivity, and carotid ultrasound and laboratorial tests, including analysis of serum aldosterone. The intervention group (IG) (n =15) underwent aerobic exercise during hemodialysis 3 times a week for 4 months. The control group (CG) (n =15) had no intervention. All of the patients were reassessed after 4 months.
RESULTS


In the IG, there was a statistically significant improvement in flow-mediated vasodilation (FMV; p = 0.002) and a reduction in left ventricular hypertrophy (p = 0.006) and serum aldosterone (p = 0.016). There was an increase in C-reactive protein in the CG (p = 0.002).
CONCLUSION


This aerobic training protocol was able to improve endothelial function with enhanced FMV and reduce left ventricular hypertrophy and serum aldosterone, which could have a positive impact on the reduction of nontraditional cardiovascular risk factors in CKD patients on hemodialysis.",2019,"This aerobic training protocol was able to improve endothelial function with enhanced FMV and reduce left ventricular hypertrophy and serum aldosterone, which could have a positive impact on the reduction of nontraditional cardiovascular risk factors in CKD patients on hemodialysis.","['Hemodialysis Patients', 'Chronic kidney disease (CKD) patients', 'Thirty patients underwent an', 'CKD patients on hemodialysis']","['exercise treadmill test', 'aerobic exercise', 'Aerobic Exercise Training', 'aerobic training']","['serum aldosterone', 'flow-mediated vasodilation', 'left ventricular hypertrophy', 'nontraditional cardiovascular risk factors', 'C-reactive protein', 'endothelial function']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0428395', 'cui_str': 'Aldosterone measurement, serum (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",30.0,0.0269072,"This aerobic training protocol was able to improve endothelial function with enhanced FMV and reduce left ventricular hypertrophy and serum aldosterone, which could have a positive impact on the reduction of nontraditional cardiovascular risk factors in CKD patients on hemodialysis.","[{'ForeName': 'Viviana Rugolo', 'Initials': 'VR', 'LastName': 'Oliveira E Silva', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil, viviana_rugolo@yahoo.com.br.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Stringuetta Belik', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Hueb', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'de Souza Gonçalves', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Costa Teixeira Caramori', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Perez Vogt', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Pasqual', 'Initials': 'P', 'LastName': 'Barretti', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Silméia Garcia', 'Initials': 'SG', 'LastName': 'Zanati Bazan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Greicy Mara Mengue Feniman', 'Initials': 'GMMF', 'LastName': 'De Stefano', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Luis Cuadrado', 'Initials': 'LC', 'LastName': 'Martin', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Roberto Jorge', 'Initials': 'RJ', 'LastName': 'da Silva Franco', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil.'}]",Cardiorenal medicine,['10.1159/000501589']
959,30404563,Coenzyme Q10 supplementation in acute ischemic stroke: Is it beneficial in short-term administration?,"Backgrounds and aims:  Clinical studies demonstrated that the efficacy of Coenzyme Q10 (CoQ10) as an adjuvant therapeutic agent in several neurological diseases such as Parkinson disease (PD), Huntington disease (HD), and migraine. The purpose of this study is to investigate oxidative stress effects, antioxidant enzymes activity, neuroinflammatory markers levels, and neurological outcome in acute ischemic stroke (AIS) patients following administration of CoQ10 (300 mg/day).  Methods:  Patients with AIS ( n  = 60) were randomly assigned to a placebo group (wheat starch,  n  = 30) or CoQ10-supplemented group (300 mg/day,  n  = 30). The intervention was administered for 4 weeks. Serum CoQ10 concentration, malondialdehyde (MDA), superoxide dismutase (SOD) activity, glial fibrillary acidic protein (GFAP) levels as primary outcomes and National Institute of Health Stroke Scale (NIHSS), Modified Ranking Scale (MRS), and Mini-Mental State Examination (MMSE) as secondary outcome were measured at the both beginning and end of the study.  Results:  Forty-four subjects with AIS completed the intervention study. A significant increase in CoQ10 level was observed in the supplement-treated group compared with placebo group (mean difference = 26.05 ± 26.63 ng/ml, 14.12 ± 14.69 ng/ml, respectively;  P  = 0.01), moreover CoQ10 supplementation improved NIHSS and MMSE scores significantly ( P  = 0.05,  P  = 0.03 respectively). but there were no statistically significant differences in MRS score, MDA, SOD, and GFAP levels between the two groups.  Conclusions:  CoQ10 probably due to low dose and short duration of supplementation, no favorable effects on MDA level, SOD activity and GFAP level.",2020,"Serum CoQ10 concentration, malondialdehyde (MDA), superoxide dismutase (SOD) activity, glial fibrillary acidic protein (GFAP) levels as primary outcomes and National Institute of Health Stroke Scale (NIHSS), Modified Ranking Scale (MRS), and Mini-Mental State Examination (MMSE) as secondary outcome were measured at the both beginning and end of the study.
","['acute ischemic stroke', 'acute ischemic stroke (AIS) patients following administration of CoQ10 (300\u2005mg/day', 'Forty-four subjects with AIS completed the intervention study', 'Patients with AIS (n\u2009=\u200960']","['Coenzyme Q10 supplementation', 'placebo group (wheat starch, n\u2009=\u200930) or CoQ10-supplemented', 'Coenzyme Q10 (CoQ10', 'placebo']","['MRS score, MDA, SOD, and GFAP levels', 'Serum CoQ10 concentration, malondialdehyde (MDA), superoxide dismutase (SOD) activity, glial fibrillary acidic protein (GFAP) levels as primary outcomes and National Institute of Health Stroke Scale (NIHSS), Modified Ranking Scale (MRS), and Mini-Mental State Examination (MMSE', 'MDA level, SOD activity and GFAP level', 'CoQ10 level', 'moreover CoQ10 supplementation improved NIHSS and MMSE scores']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0772389', 'cui_str': 'STARCH, WHEAT'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0017626', 'cui_str': 'Glial Intermediate Filament Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",44.0,0.131769,"Serum CoQ10 concentration, malondialdehyde (MDA), superoxide dismutase (SOD) activity, glial fibrillary acidic protein (GFAP) levels as primary outcomes and National Institute of Health Stroke Scale (NIHSS), Modified Ranking Scale (MRS), and Mini-Mental State Examination (MMSE) as secondary outcome were measured at the both beginning and end of the study.
","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sahraei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Simani', 'Affiliation': 'Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Heydari', 'Affiliation': 'Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shahidi', 'Affiliation': 'Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nutritional neuroscience,['10.1080/1028415X.2018.1541269']
960,31578173,"Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study.","BACKGROUND


In the phase 3 TITAN study, the addition of apalutamide to androgen deprivation therapy (ADT) significantly improved the primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer. We aimed to assess health-related quality of life (HRQOL) in TITAN, including pain and fatigue.
METHODS


In this randomised, placebo-controlled, double-blind, phase 3 study, patients with metastatic castration-sensitive prostate cancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1 were randomly assigned (1:1), using an interactive web response system, to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo. Previous localised disease treatment or previous docetaxel for metastatic castration-sensitive prostate cancer were allowed. Randomisation was stratified by Gleason score at diagnosis, region, and previous docetaxel treatment. Randomisation was done using randomly permuted blocks (block size of four). Investigators, research staff, sponsor study team, and patients were masked to the identities of test and control treatments. Patient-reported outcomes were prespecified exploratory endpoints and were the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L). BPI and BFI were completed for 7 consecutive days (days -6 to 1 inclusive of each cycle visit), then at months 4, 8, and 12 in follow-up. FACT-P and EQ-5D-5L were completed during cycles 1-7, then every other cycle until the end of treatment, and at months 4, 8, and 12 in follow-up. Analyses were based on the intention-to-treat population. Missing patient-reported outcome assessments were calculated as the expected number of assessments for a visit minus the actual number of assessments received for that visit. For time-to-event endpoints, when median values could not be calculated because less than 50% of patients had degradation, 25th percentiles were compared. This study is registered with ClinicalTrials.gov, number NCT02489318, and is ongoing.
FINDINGS


Between Dec 9, 2015, and July 25, 2017, 1052 eligible patients were enrolled randomly assigned to apalutamide (n=525) or placebo (n=527). Data cutoff for this analysis of patient-reported outcomes was Nov 23, 2018. Median follow-up for time to pain-related endpoints ranged from 19·4 to 22·1 months. Patients were mostly asymptomatic at baseline: on the BPI-SF pain severity scale of 0-10, median pain scores (indicating worst pain in the past 24 h) were 1·14 (IQR 0-3·17) in the apalutamide group and 1·00 (0-2·86) in the placebo group, and median worst fatigue scores on the BFI were 1·29 (IQR 0-3·29) in the apalutamide group and 1·43 (0·14-3·14) in the placebo group. Patient experience of pain and fatigue (intensity and interference) did not differ between the groups for the duration of treatment. Median time to worst pain intensity progression was 19·09 months (95% CI 11·04-not reached) in the apalutamide group versus 11·99 months (8·28-18·46) in the placebo group (HR 0·89 [95% CI 0·75-1·06]; p=0·20). Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group). 25th percentiles for time to pain interference progression were 9·17 months (5·55-11·96) in the apalutamide group and 6·24 months (4·63-7·43) in the placebo group (HR 0·90 [95% CI 0·73-1·10]; p=0·29). FACT-P total scores and EQ-5D-5L data showed preservation of HRQOL in both groups. The median time to deterioration as determined by FACT-P total score was 8·87 months (95% CI 4·70-11·10) in the apalutamide group and 9·23 months (7·39-12·91) in the placebo group (HR 1·02 [95% CI 0·85-1·22]; p=0·85).
INTERPRETATION


Apalutamide with ADT is a well-tolerated and effective option for men with metastatic castration-sensitive prostate cancer. The combination significantly improves survival outcomes compared with ADT alone while maintaining HRQOL despite additive androgen blockade.
FUNDING


Janssen Research & Development.",2019,Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group).,"['men with metastatic castration-sensitive prostate cancer', ""patients with metastatic castration-sensitive prostate cancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1"", 'Between Dec 9, 2015, and July 25, 2017, 1052 eligible patients', 'patients with metastatic castration-sensitive prostate cancer', 'metastatic castration-sensitive prostate cancer', 'patients with metastatic castration-sensitive prostate cancer (TITAN']","['docetaxel', 'apalutamide to androgen deprivation therapy (ADT', 'ADT', 'apalutamide', 'placebo', 'interactive web response system, to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo']","['BPI-SF pain severity scale of 0-10, median pain scores', 'FACT-P total score', 'overall survival and radiographic progression-free survival', 'health-related quality of life (HRQOL) in TITAN, including pain and fatigue', 'FACT-P and EQ-5D-5L', 'survival outcomes', 'BPI and BFI', 'pain interference progression', 'Median time to worst pain intensity progression', 'median time to deterioration', 'pain and fatigue (intensity and interference', 'Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L', 'median worst fatigue scores', 'Health-related quality of life', 'Median time to pain interference progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242756', 'cui_str': 'Titan'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242756', 'cui_str': 'Titan'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1052.0,0.607179,Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group).,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Genitourinary Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: neeraj.agarwal@hci.utah.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McQuarrie', 'Affiliation': 'Patient Reported Outcome Group, Janssen Research & Development, Horsham, PA, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Urological Cancer, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Urological Cancer, Guy's, King's, and St Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK.""}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Pereira de Santana Gomes', 'Affiliation': 'Oncology, Liga Norte Riograndense Contra O Cancer, Natal, Brazil.'}, {'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Chung', 'Affiliation': 'Yonsei University College of Medicine and Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Oncology, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Juárez Soto', 'Affiliation': 'Urology, Hospital Universitario de Jerez de la Frontera, Cadiz, Spain.'}, {'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'Urology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Given', 'Affiliation': 'Urology, Urology of Virginia, Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Miladinovic', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Dearden', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Deprince', 'Affiliation': 'Oncology, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naini', 'Affiliation': 'Clinical Oncology, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lopez-Gitlitz', 'Affiliation': 'Clinical Oncology, Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30620-5']
961,31246796,"The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial.","BACKGROUND


Postoperative pain control after abdominally based autologous microvascular breast reconstruction is critical to functional recovery, patient satisfaction, and early discharge. The transversus abdominis plane block using 0.25% bupivacaine hydrochloride has been shown to be effective, but it is limited by a short duration of effect. Liposomal bupivacaine is a recently U.S. Food and Drug Administration-approved preparation of bupivacaine that can provide up to 72 hours of pain relief. The purpose of this randomized, controlled trial was to compare the analgesic efficacy of liposomal bupivacaine and conventional bupivacaine.
METHODS


This study was a prospective, single-blind, randomized, controlled trial of 44 patients undergoing abdominally based autologous breast reconstruction between June of 2016 and February of 2018 performed by a single surgeon. Each patient was randomized to receive either 266 mg of liposomal bupivacaine or 75 mg of conventional bupivacaine to the transversus abdominis plane at the conclusion of the reconstruction procedure. All patients were managed postoperatively according to an enhanced recovery protocol.
RESULTS


In our study of 44 patients, 22 patients received a transversus abdominis plane block with conventional bupivacaine and 22 patients received liposomal bupivacaine. There were no significant differences with regard to any outcome measure. No differences were found in total opioid consumption (p = 0.98), Quality of Recovery-15 scores (p = 0.72), pain scores (p = 0.39), or length of stay (p = 0.20).
CONCLUSION


In the setting of a robust enhanced recovery after surgery protocol, liposomal bupivacaine does not confer advantages over conventional bupivacaine when used as single injections in transversus abdominis plane blocks after abdominally based microvascular breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2019,"No differences were found in total opioid consumption (p = 0.98), Quality of Recovery-15 scores (p = 0.72), pain scores (p = 0.39), or length of stay (p = 0.20).
","['44 patients undergoing abdominally based autologous breast reconstruction between June of 2016 and February of 2018 performed by a single surgeon', '44 patients, 22 patients received a', 'after Abdominally Based Autologous Microvascular Breast Reconstruction']","['liposomal bupivacaine and conventional bupivacaine', 'liposomal bupivacaine', 'Liposomal Bupivacaine', 'conventional bupivacaine', 'bupivacaine', 'Bupivacaine Hydrochloride', 'bupivacaine hydrochloride', 'Liposomal bupivacaine', 'transversus abdominis plane block with conventional bupivacaine']","['Transversus Abdominis Plane Block', 'analgesic efficacy', 'total opioid consumption', 'pain scores', 'length of stay', 'Quality of Recovery-15 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",44.0,0.264145,"No differences were found in total opioid consumption (p = 0.98), Quality of Recovery-15 scores (p = 0.72), pain scores (p = 0.39), or length of stay (p = 0.20).
","[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': ""Saint Louis, Mo.; and Wuhan, People's Republic of China From the Division of Plastic and Reconstructive Surgery, the Division of Public Health Sciences, and the Department of Anesthesiology, Washington University School of Medicine in St. Louis; and the Department of Anesthesiology, Wuhan No. 1 Hospital.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Keane', 'Affiliation': ''}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Odom', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000005698']
962,30500967,Azithromycin-based Extended-Spectrum Antibiotic Prophylaxis for Cesarean: Role of Placental Colonization with Genital Ureaplasmas and Mycoplasmas.,"OBJECTIVE


To explore whether the effect of azithromycin (AZI) on postcesarean infections varied by the presence/absence of genital mycoplasmataceae placental colonization.
STUDY DESIGN


This was a single-center substudy of multicenter double-blind C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial of women randomized to AZI or placebo (+cefazolin) antibiotic prophylaxis at cesarean. Chorioamnion/placenta specimens were tested for genital mycoplasmataceae colonization by polymerase chain reaction. Primary outcome was a composite of endometritis, wound infection, or other infections up to 6 weeks postpartum. Analysis was intent-to-treat; logistic regression was used to evaluate interactions between treatment assignment (AZI/placebo) and the presence/absence of mycoplasmataceae and to quantify effects of AZI in analyses stratified by the presence/absence of these microorganisms.
RESULTS


Specimens from 613 women (303 AZI and 310 placebo) were evaluated. Baseline characteristics were similar between groups, and approximately 1/3 (30.3%) had mycoplasmataceae placental/chorioamnion colonization. There was no evidence of effect modification ( p   interaction  = 0.79) between treatment assignment and the presence/absence of organisms. Stratified analyses showed fewer events in the AZI group in the presence (odds ratio [OR]: 0.42; 95% confidence interval [CI]: 0.17-1.01) and absence (OR: 0.49; 95% CI: 0.24-1) of mycoplasmataceae. Results were similar with endometritis/wound infections and with ureaplasmas/mycoplasmas considered separately.
CONCLUSION


The reduction in postcesarean infection with AZI does not vary based on the presence or absence of genital mycoplasmataceae placental colonization.",2019,The reduction in postcesarean infection with AZI does not vary based on the presence or absence of genital mycoplasmataceae placental colonization.,"['Specimens from 613 women (303 AZI and 310', 'Cesarean']","['placebo', 'SOAP (Cesarean Section Optimal Antibiotic Prophylaxis', 'Azithromycin-based Extended-Spectrum Antibiotic Prophylaxis', 'AZI or placebo (+cefazolin) antibiotic prophylaxis', 'azithromycin (AZI']","['composite of endometritis, wound infection, or other infections up to 6 weeks postpartum', 'mycoplasmataceae placental/chorioamnion colonization', 'endometritis/wound infections']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026943', 'cui_str': 'Mycoplasmataceae'}]",613.0,0.543898,The reduction in postcesarean infection with AZI does not vary based on the presence or absence of genital mycoplasmataceae placental colonization.,"[{'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Division of Laboratory Medicine, Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Jauk', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Amelia L M', 'Initials': 'ALM', 'LastName': 'Sutton', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Andrews', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.""}]",American journal of perinatology,['10.1055/s-0038-1675766']
963,30663462,Performance and perception of haptic feedback in a laparoscopic 3D virtual reality simulator.,"Background:  The benefit of haptic feedback in laparoscopic virtual reality simulators (VRS) is ambiguous. A previous study found 32% faster acquisition of skills with the combination of 3 D and haptic feedback compared to 2 D only. This study aimed to validate perception and effect on performance of haptic feedback by experienced surgeons in the previously tested VRS.  Material and methods:  A randomized single blinded cross-over study with laparoscopists (>100 laparoscopic procedures) was conducted in a VRS with 3 D imaging. One group started with haptic feedback, and the other group without. After performing the suturing task with haptics either enabled or disabled, the groups crossed over to the opposite setting. Face validity was assessed through questionnaires. Metrics were obtained from the VRS.  Results:  The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively. Comparing the metrics for maximum stretch damage between the groups revealed a significantly lower score when a group performed with haptics enabled  p  = .027 (haptic first group) and  p  < .001(haptic last group).  Conclusion:  Haptic feedback in VRS has limited fidelity according to the tested laparoscopic surgeons. In spite of this, significantly less stretch damage was caused with haptics enabled.",2019,"The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively.",['A randomized single blinded cross-over study with laparoscopists (>100 laparoscopic procedures'],"['laparoscopic virtual reality simulators (VRS', 'haptic feedback']","['Performance and perception of haptic feedback', 'Face validity', 'Haptic feedback', 'performance of haptic feedback', 'haptic feedback']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0521291', 'cui_str': 'Laparoscopic-assisted procedure'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042284', 'cui_str': 'Validity of Results'}]",,0.0537111,"The haptics for 'handling the needle', 'needle through tissue' and 'tying the knot' was scored as completely realistic by 3/22, 1/22 and 2/22 respectively.","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Hagelsteen', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bergenfelz', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Anderberg', 'Affiliation': 'Practicum Clinical Skills Centre, Skåne University Hospital, Lund, Sweden.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2018.1539012']
964,31678098,Dose-Finding Study of Lorexys for Hypoactive Sexual Desire Disorder in Premenopausal Women.,"INTRODUCTION


Prior medication treatment for hypoactive sexual desire disorder (HSDD) in women has left about half the subjects without benefit. Lorexys (LOR), a proprietary combination of the stimulating/excitatory dopamine-norepinephrine reuptake inhibitor bupropion (BUP) and the sedating/inhibitory serotonergic agonist-antagonist trazodone (TRZ), was developed as a multifunctional solution for this problem.
AIM


Test efficacy, safety, and tolerability of LOR in a range of doses in a combined phase IB/IIA study in premenopausal outpatients with HSDD.
METHODS


Otherwise healthy premenopausal women from 25-50 years of age with HSDD were tested in an open-label, active-control, one-way crossover study, with three 4-week treatments of extended-release TRZ and/or sustained-release BUP. Evaluations were made before and after each treatment. A washout of at least a week followed each treatment. The order of treatments was a standard dose of BUP; a subtherapeutic dose of BUP and TRZ (LOR-low); and a threshold-therapeutic dose of BUP and TRZ (LOR-mod). A midpoint interim analysis was planned to consider adapting doses for efficacy or safety.
MAIN OUTCOME MEASURE


The primary efficacy measure was the Female Sexual Function Index, Desire domain; the main secondary efficacy measures included the Female Sexual Distress Scale-Revised 13th item, on bother about low desire, and a Patient's Global Impression of Change. The main outcome comparison was the proportions of responders. Safety measures were elicited adverse events, Epworth Sleepiness Scale, Columbia Suicide Severity Rating Scale 6-item SCREEN version, vital signs, electrocardiograms, and standard laboratory tests.
RESULTS


Interim analysis did not require altering doses. Most evaluable subjects responded to LOR-mod (at the standard thresholds for response based on minimum clinically relevant difference from baseline, 79% on Female Sexual Function Index, Desire domain, 87% on Female Sexual Distress Scale-Revised Item 13, and 79% on Patient's Global Impression of Change; each P < .05 vs BUP). As expected, close to half responded to BUP (38%, 45%, and 52%, respectively). Response to LOR-low was intermediate (not significant vs BUP). Sensitivity analyses to compensate for carryover effects supported the efficacy of LOR-mod. Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
CLINICAL IMPLICATIONS


The open-label 1-way crossover design of this phase IB/IIA study limits conclusions, but the consistency of responder analyses showing superiority of LOR-mod dose over control, and the lack of central depressant dropouts, favor further development in double-blind placebo-control trials.
STRENGTH & LIMITATIONS


Strengths include large margins of efficacy over control agent, rapid onset of action, and rigorous safety assessment. Limitations are open-label, cross-over design/lack of placebo control and 1-month duration of exposure.
CONCLUSION


Moderate-dose LOR was generally well-tolerated and was significantly more effective than BUP (active control). The results seem highly favorable compared to previously tested agents. Pyke RE, Clayton AH. Dose-Finding Study of Lorexys for Hypoactive Sexual Desire Disorder in Premenopausal Women. J Sex Med 2019;16:1885-1894.",2019,"Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
","['premenopausal outpatients with HSDD', 'Premenopausal Women', 'Otherwise healthy premenopausal women from 25-50 years of age with HSDD']","['TRZ', 'Lorexys', 'BUP and TRZ (LOR-mod', 'BUP and TRZ (LOR-low', 'norepinephrine reuptake inhibitor bupropion (BUP) and the sedating/inhibitory serotonergic agonist-antagonist trazodone (TRZ']","['elicited adverse events, Epworth Sleepiness Scale, Columbia Suicide Severity Rating Scale 6-item SCREEN version, vital signs, electrocardiograms, and standard laboratory tests', 'Female Sexual Function Index, Desire domain', 'Female Sexual Distress Scale', 'Epworth Sleepiness Scale', ""Female Sexual Distress Scale-Revised 13th item, on bother about low desire, and a Patient's Global Impression of Change"", 'efficacy, safety, and tolerability of LOR']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0162757', 'cui_str': '5-Hydroxytryptamine Agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0352528,"Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Pyke', 'Affiliation': 'President, Pykonsult, LLC, 23 Eastview Drive, New Fairfield, CT, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia, 2955 Ivy Road, Suite 210, Charlottesville, VA, USA. Electronic address: AHC8V@virginia.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.09.005']
965,31668592,"Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.","BACKGROUND


Myeloma causes profound immunodeficiency and recurrent, serious infections. Around 5500 new cases of myeloma are diagnosed per year in the UK, and a quarter of patients will have a serious infection within 3 months of diagnosis. We aimed to assess whether patients newly diagnosed with myeloma benefit from antibiotic prophylaxis to prevent infection, and to investigate the effect on antibiotic-resistant organism carriage and health care-associated infections in patients with newly diagnosed myeloma.
METHODS


TEAMM was a prospective, multicentre, double-blind, placebo-controlled randomised trial in patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals. All enrolled patients were within 14 days of starting active myeloma treatment. We randomly assigned patients (1:1) to levofloxacin or placebo with a computerised minimisation algorithm. Allocation was stratified by centre, estimated glomerular filtration rate, and intention to proceed to high-dose chemotherapy with autologous stem cell transplantation. All investigators, patients, laboratory, and trial co-ordination staff were masked to the treatment allocation. Patients were given 500 mg of levofloxacin (two 250 mg tablets), orally once daily for 12 weeks, or placebo tablets (two tablets, orally once daily for 12 weeks), with dose reduction according to estimated glomerular filtration rate every 4 weeks. Follow-up visits occurred every 4 weeks up to week 16, and at 1 year. The primary outcome was time to first febrile episode or death from all causes within the first 12 weeks of trial treatment. All randomised patients were included in an intention-to-treat analysis of the primary endpoint. This study is registered with the ISRCTN registry, number ISRCTN51731976, and the EU Clinical Trials Register, number 2011-000366-35.
FINDINGS


Between Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive levofloxacin prophylaxis (489 patients) or placebo (488 patients). Median follow-up was 12 months (IQR 8-13). 95 (19%) first febrile episodes or deaths occurred in 489 patients in the levofloxacin group versus 134 (27%) in 488 patients in the placebo group (hazard ratio 0·66, 95% CI 0·51-0·86; p=0·0018. 597 serious adverse events were reported up to 16 weeks from the start of trial treatment (308 [52%] of which were in the levofloxacin group and 289 [48%] of which were in the placebo group). Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
INTERPRETATION


Addition of prophylactic levofloxacin to active myeloma treatment during the first 12 weeks of therapy significantly reduced febrile episodes and deaths compared with placebo without increasing health care-associated infections. These results suggest that prophylactic levofloxacin could be used for patients with newly diagnosed myeloma undergoing anti-myeloma therapy.
FUNDING


UK National Institute for Health Research.",2019,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
","['patients with newly diagnosed myeloma undergoing anti-myeloma therapy', 'patients with newly diagnosed myeloma', 'patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals', 'patients newly diagnosed with myeloma benefit from', '488 patients', 'patients with newly diagnosed myeloma (TEAMM', '489 patients) or', 'number 2011-000366-35.\nFINDINGS\n\n\nBetween Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive']","['levofloxacin prophylaxis', 'levofloxacin or placebo', 'levofloxacin', 'placebo tablets', 'placebo', 'prophylactic levofloxacin', 'chemotherapy with autologous stem cell transplantation', 'antibiotic prophylaxis', 'Levofloxacin prophylaxis']","['febrile episodes or deaths', '597 serious adverse events', 'time to first febrile episode or death', 'Serious adverse events', 'febrile episodes and deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",977.0,0.742669,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.
","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'School of Immunity and Infection, University of Birmingham, Birmingham, UK. Electronic address: m.t.drayson@bham.ac.uk.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Trust, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospitals Birmingham NHS Trust, Birmingham, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Monahan', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospitals North Midlands NHS Trust, Stoke On Trent, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dignum', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Belsham', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': 'The Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Harrison', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Lokare', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Campbell', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamblin', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'West Midlands Public Health Laboratory, Heart of England NHS Trust, Birmingham, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Low', 'Affiliation': 'Patient Advocacy, Myeloma UK, Edinburgh UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30506-6']
966,30506594,Randomised controlled trial on the impact of kinesthetic stimulation on early somatic growth of preterm infants in Kangaroo position.,"AIM


Evaluation of early growth in preterm infants receiving kinesthetic stimulation with massage in Kangaroo position or in incubator.
METHODS


A cohort of 66 infants between 30 and 33 weeks of gestational age (GA), born at a university hospital in 2013 in Bogota, were randomised when eligible to intervention. We measured weight gain (g/kg/day) at five days and 15 days postrandomisation and weight at 40 weeks, according to chronological age at randomisation.
RESULTS


Daily weight gain was significantly higher (p = 0.02) with kinesthetic stimulation in Kangaroo position with a growth at five days of 11.0 g/kg/day (95% CI 5.7;16.3) and at 15 days of 12.1 g/kg/day (95% CI 10.4;13.7) versus 2.1 g/kg/day (95% CI -3.1;7.4) at five days and 9.4 g/kg/day (95% CI 7.7;11.1) at 15 days in incubator. Weight at 40 weeks was higher (p = 0.05) in Kangaroo position group (2.904 g) than in incubator group (2.722 g) (95% CI 2.784;3.007). Daily weight gain according to chronological age at randomisation was higher when kinesthetic stimulation initiates before five days of life in Kangaroo position with 1.53 g/kg/day (95% CI 5.9;9.0) versus -11.9 g/kg/day (95% CI -19.0;-4.8) in incubator.
CONCLUSION


Early kinesthetic stimulation in Kangaroo position reduces the initial weight loss in infants between 30-33 weeks born without major health problems.",2019,"RESULTS


Daily weight gain was significantly higher (p = 0.02) with kinesthetic stimulation in Kangaroo position with a growth at five days of 11.0 g/kg/day (95% CI 5.7;16.3) and at 15 days of 12.1 g/kg/day (95% CI 10.4;13.7) versus 2.1 g/kg/day (95% CI -3.1;7.4) at five days and 9.4 g/kg/day (95% CI 7.7;11.1) at 15 days in incubator.","['preterm infants in Kangaroo position', 'preterm infants receiving kinesthetic stimulation with massage in Kangaroo position or in incubator', '66 infants between 30 and 33\xa0weeks of gestational age (GA), born at a university hospital in 2013 in Bogota', 'infants between 30-33\xa0weeks born without major health problems']","['kinesthetic stimulation', 'Kangaroo position']","['initial weight loss', 'Weight', 'Daily weight gain', 'weight gain']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1510459', 'cui_str': 'Kangaroo'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1510459', 'cui_str': 'Kangaroo'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",66.0,0.21219,"RESULTS


Daily weight gain was significantly higher (p = 0.02) with kinesthetic stimulation in Kangaroo position with a growth at five days of 11.0 g/kg/day (95% CI 5.7;16.3) and at 15 days of 12.1 g/kg/day (95% CI 10.4;13.7) versus 2.1 g/kg/day (95% CI -3.1;7.4) at five days and 9.4 g/kg/day (95% CI 7.7;11.1) at 15 days in incubator.","[{'ForeName': 'Andrea Carolina', 'Initials': 'AC', 'LastName': 'Aldana Acosta', 'Affiliation': 'Department of Psychology, Universidad Piloto de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Rejean', 'Initials': 'R', 'LastName': 'Tessier', 'Affiliation': 'Department of Psychology, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Charpak', 'Affiliation': 'Fundacion Canguro, Bogotá, Colombia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tarabulsy', 'Affiliation': 'Department of Psychology, Laval University, Quebec City, QC, Canada.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14675']
967,31660398,Atovaquone-Proguanil in Combination With Artesunate to Treat Multidrug-Resistant  P. falciparum  Malaria in Cambodia: An Open-Label Randomized Trial.,"Background


Recent artemisinin-combination therapy failures in Cambodia prompted a search for alternatives. Atovaquone-proguanil (AP), a safe, effective treatment for multidrug-resistant  Plasmodium falciparum  ( P.f. ), previously demonstrated additive effects in combination with artesunate (AS).
Methods


Patients with  P.f.  or mixed-species infection (n = 205) in Anlong Veng (AV; n = 157) and Kratie (KT; n = 48), Cambodia, were randomized open-label 1:1 to a fixed-dose 3-day AP regimen +/-3 days of co-administered artesunate (ASAP). Single low-dose primaquine (PQ, 15 mg) was given on day 1 to prevent gametocyte-mediated transmission.
Results


Polymerase chain reaction-adjusted adequate clinical and parasitological response at 42 days was 90% for AP (95% confidence interval [CI], 82%-95%) and 92% for ASAP (95% CI, 83%-96%;  P  = .73). The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone. At 1 week postprimaquine, 7% of the ASAP group carried microscopic gametocytes vs 29% for AP alone ( P  = .0001). Nearly all  P.f.  isolates had C580Y K13 propeller artemisinin resistance mutations (AV 99%; KT 88%). Only 1 of 14 treatment failures carried the cytochrome bc1 (Pfcytb) atovaquone resistance mutation, which was not present at baseline.  P.f.  isolates remained atovaquone sensitive in vitro but cycloguanil resistant, with a triple  P.f.  dihydrofolate reductase mutation.
Conclusions


Atovaquone-proguanil remained marginally effective in Cambodia (≥90%) with minimal Pfcytb mutations observed. Treatment failures in the presence of ex vivo atovaquone sensitivity and adequate plasma levels may be attributable to cycloguanil and/or artemisinin resistance. Artesunate co-administration provided little additional blood-stage efficacy but reduced post-treatment gametocyte carriage in combination with AP beyond single low-dose primaquine.",2019,The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone.,"['P. falciparum  Malaria in Cambodia', 'Methods\n\n\nPatients with  P.f.  or', 'mixed-species infection (n = 205) in Anlong Veng (AV; n = 157) and Kratie (KT; n = 48), Cambodia']","['artesunate (AS', 'fixed-dose 3-day AP regimen +/-3 days of co-administered artesunate (ASAP', 'Atovaquone-proguanil (AP', 'primaquine (PQ', 'primaquine', 'Atovaquone-Proguanil in Combination With Artesunate', 'ASAP']","['microscopic gametocytes', 'Polymerase chain reaction-adjusted adequate clinical and parasitological response', 'cytochrome bc1 (Pfcytb) atovaquone resistance mutation', 'additional blood-stage efficacy', 'median parasite clearance time', 'C580Y K13 propeller artemisinin resistance mutations']","[{'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0052143', 'cui_str': 'AP protocol 1'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0939219', 'cui_str': 'Atovaquone / Proguanil'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic (qualifier value)'}, {'cui': 'C0041535', 'cui_str': 'Cytochrome bc1'}, {'cui': 'C0165603', 'cui_str': 'Atovaquone'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0005768'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}]",,0.17852,The median parasite clearance time was 72 hours for ASAP in AV vs 56 hours in KT ( P  < .001) and was no different than AP alone.,"[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Wojnarski', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Chanthap', 'Initials': 'C', 'LastName': 'Lon', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Pattaraporn', 'Initials': 'P', 'LastName': 'Vanachayangkul', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Panita', 'Initials': 'P', 'LastName': 'Gosi', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Somethy', 'Initials': 'S', 'LastName': 'Sok', 'Affiliation': 'Department of Health, Ministry of National Defense, Phnom Penh, Cambodia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Rachmat', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Harrison', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Berjohn', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Spring', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Suwanna', 'Initials': 'S', 'LastName': 'Chaoratanakawee', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Mali', 'Initials': 'M', 'LastName': 'Ittiverakul', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nillawan', 'Initials': 'N', 'LastName': 'Buathong', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Soklyda', 'Initials': 'S', 'LastName': 'Chann', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Saowaluk', 'Initials': 'S', 'LastName': 'Wongarunkochakorn', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Waltmann', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, Maryland.'}, {'ForeName': 'Worachet', 'Initials': 'W', 'LastName': 'Kuntawunginn', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Fukuda', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Burkly', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Vireak', 'Initials': 'V', 'LastName': 'Heang', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Thay Keang', 'Initials': 'TK', 'LastName': 'Heng', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Nareth', 'Initials': 'N', 'LastName': 'Kong', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Threechada', 'Initials': 'T', 'LastName': 'Boonchan', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Chum', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vaughn', 'Affiliation': 'Naval Medical Research Unit-2, Phnom Penh, Cambodia.'}, {'ForeName': 'Satharath', 'Initials': 'S', 'LastName': 'Prom', 'Affiliation': 'Department of Health, Ministry of National Defense, Phnom Penh, Cambodia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'US Army Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}]",Open forum infectious diseases,['10.1093/ofid/ofz314']
968,30576555,Short-term Efficiency and Tolerance of Ketoprofen and Methylprednisolone in Acute Sciatica: A Randomized Trial.,"OBJECTIVE


Although anti-inflammatory drugs are commonly used in acute discogenic sciatica, data regarding their efficacy are scarce and controversial. We compared the efficacy and safety of intravenous ketoprofen and methylprednisolone with placebo in sciatica.
DESIGN


Multicenter, double-blinded randomized controlled trial.
SUBJECTS


Patients with confirmed discogenic acute sciatica, without neurologic deficit, were randomized into three arms.
METHODS


Besides standard-of-care analgesic therapy, they received intravenous injections of methylprednisolone (60 mg/d) or ketoprofen (200 mg/d) or placebo for five days. The primary outcome was leg pain over five days. Secondary outcomes were clinical responses at days 3 and 5, lumbar pain, Straight Leg Raise Test and lumbar flexion index, analgesic consumption, realization of lumbar spine injections, and surgery during the study period.
RESULTS


Fifty-four patients were randomized, and 50 completed the study. In patients admitted to the hospital for pain control with acute lumbar radicular pain due to intervertebral disc herniation and receiving an oral analgesic protocol including paracetamol, nefopam, tramadol, and morphine, there was no additional analgesic effect seen between groups. There was no significant difference in leg pain between the three groups over the study period. In the methylprednisolone group, however, we observed a higher rate of clinically relevant responses at day 3. No difference was observed on other secondary efficacy outcomes and safety.
CONCLUSION


No significant difference in leg pain was observed between groups. However, there was a higher proportion of patients relieved with intravenous methylprednisolone at day 3, compared with ketoprofen or placebo.",2019,There was no significant difference in leg pain between the three groups over the study period.,"['patients admitted to the hospital for pain control with acute lumbar radicular pain due to intervertebral disc herniation and receiving an', 'Acute Sciatica', 'Subjects\n\n\nPatients with confirmed discogenic acute sciatica, without neurologic deficit', 'Fifty-four patients were randomized, and 50 completed the study']","['ketoprofen', 'placebo', 'methylprednisolone', 'oral analgesic protocol including paracetamol, nefopam, tramadol, and morphine', 'Ketoprofen and Methylprednisolone', 'ketoprofen or placebo', 'ketoprofen and methylprednisolone with placebo', 'Methods\n\n\nBesides standard-of-care analgesic therapy']","['higher rate of clinically relevant responses', 'leg pain', 'clinical responses at days 3 and 5, lumbar pain, Straight Leg Raise Test and lumbar flexion index, analgesic consumption, realization of lumbar spine injections, and surgery during the study period', 'efficacy and safety', 'secondary efficacy outcomes and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse (disorder)'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica (disorder)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",54.0,0.428504,There was no significant difference in leg pain between the three groups over the study period.,"[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Gastaldi', 'Affiliation': 'Rheumatology Department, CHU Grenoble Alpes Hôpital Sud, Echirolles, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Durand', 'Affiliation': 'Pharmacy Department, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Roustit', 'Affiliation': 'Université Grenoble Alpes, Inserm UMR 1042, Grenoble, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Zulian', 'Affiliation': ""Regional Hospital of Rheumatology Uriage les Bains, St Martin d'Uriage France.""}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Monteiro', 'Affiliation': 'Rheumatology Department, Regional Hospital Annecy, Metz-Tessy France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Juvin', 'Affiliation': 'Rheumatology Department, CHU Grenoble Alpes Hôpital Sud, Echirolles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble Alpes Hôpital Sud, Echirolles, France.'}, {'ForeName': 'Athan', 'Initials': 'A', 'LastName': 'Baillet', 'Affiliation': 'Rheumatology Department, CHU Grenoble Alpes Hôpital Sud, Echirolles, France.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny252']
969,31232255,Intrauterine growth restriction affects z-scores of anthropometric parameters during the first 6 years in very low-birth-weight-children born at less than 30 weeks of gestation.,"OBJECTIVE


Little is known about physical constitution outcomes for very preterm infants. Here, we compare z-scores of anthropometric parameters up to 6 years of age in children born with very low birth weight (VLBW) at less than 30 weeks of gestation, with or without intrauterine growth restriction (IUGR).
DESIGN


Participants were divided into four subgroups: male (M), small for gestational age (SGA) (n = 30); M, appropriate for gestational age (AGA) (n = 59); female (F), SGA (n = 24); and F, AGA (n = 61). z-Scores of body weight (BW), body length (BL), and body mass index (BMI) were assessed at birth, 1 year corrected age, 3 years of age, and 6 years of age.
RESULTS


For boys, BW and BMI were significantly lower among SGA children than among AGA children at all assessments, but there was no difference in BL at 3 or 6 years. For girls, BW and BL were significantly lower among SGA children than among AGA children at all assessments, but no difference was detected in BMI after 1.5 years. No significant variation in the z-score of BW or BMI in either SGA group was observed after 1 year. BL z-score in all groups gradually increased until 6 years of age.
CONCLUSION


IUGR affects BW and BMI in boys and BW and BL in girls during the first 6 years in VLBW children born at less than 30 weeks of gestation. SGA children did not catch up in BW or BMI from 1 to 6 years of age.",2020,"For girls, BW and BL were significantly lower among SGA children than among AGA children at all assessments, but no difference was detected in BMI after 1.5 years.","['very preterm infants', 'Participants were divided into four subgroups: male (M), small for gestational age (SGA) (n = 30); M, appropriate for gestational age (AGA) (n = 59); female (F), SGA (n = 24); and F, AGA (n = 61', 'children born with very low birth weight (VLBW) at less than 30 weeks of gestation, with or without intrauterine growth restriction (IUGR']",['Intrauterine growth restriction'],"['z-score of BW or BMI', 'z-Scores of body weight (BW), body length (BL), and body mass index (BMI', 'BL z-score', 'BMI']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]","[{'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",61.0,0.0209632,"For girls, BW and BL were significantly lower among SGA children than among AGA children at all assessments, but no difference was detected in BMI after 1.5 years.","[{'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Shoji', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Pediatrics, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Awaji', 'Affiliation': 'Department of Pediatrics, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of Neonatology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-shi, Shizuoka, 410-2295, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Hosozawa', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Ohkawa', 'Affiliation': 'Department of Neonatology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-shi, Shizuoka, 410-2295, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Nishizaki', 'Affiliation': 'Department of Pediatrics, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hisata', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kantake', 'Affiliation': 'Department of Neonatology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-shi, Shizuoka, 410-2295, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Obinata', 'Affiliation': 'Department of Pediatrics, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.'}]",Journal of developmental origins of health and disease,['10.1017/S2040174419000369']
970,30523732,"Bleeding Complications After Cardiac Arrest and Targeted Temperature Management, a  Post Hoc  Study of the Targeted Temperature Management Trial.","Target Temperature Management (TTM) is standard care following out of hospital cardiac arrest (OHCA). The aim of the study was to evaluate if treatment temperature (33°C or 36°C) or other predefined variables were associated with the occurrence of bleeding in the TTM study. This study is a predefined,  post hoc  analysis of the TTM trial, a multinational randomized controlled trial comparing treatment at 33°C and 36°C for 24 hours after OHCA with return of spontaneous circulation. Bleeding events from several locations were registered daily. The main outcome measure was occurrence of any bleeding during the first 3 days of intensive care. Risk factors for bleeding, including temperature allocation, were evaluated. Complete data were available for 722/939 patients. Temperature allocation was not associated with bleeding either in the univariable ( p  = 0.95) or in the primary multivariable analysis (odds ratio [OR] 0.95; 95% confidence interval [CI] 0.64-1.41,  p  = 0.80). A multiple imputation model, including all patients, was used as a sensitivity analysis, rendering similar results (OR 0.98; 95% CI 0.69-1.38,  p  = 0.92). Factors associated with bleeding were increasing age, female sex, and angiography with percutaneous coronary intervention (PCI) within 36 hours of cardiac arrest (CA) in both the primary and the sensitivity analysis. TTM at 33°C, when compared to TTM at 36°C, was not associated with an increased incidence of bleeding during the first 3 days of intensive care after CA. Increasing age, female gender, and PCI were independently associated with any bleeding the first 3 days after CA.",2019,"Temperature allocation was not associated with bleeding either in the univariable (p = 0.95) or in the primary multivariable analysis (odds ratio [OR] 0.95; 95% confidence interval [CI] 0.64-1.41,",['33°C and 36°C for 24 hours after OHCA with return of spontaneous circulation'],"['TTM', 'Target Temperature Management (TTM']","['occurrence of any bleeding during the first 3 days of intensive care', 'incidence of bleeding', 'Bleeding Complications', 'Temperature allocation', 'Bleeding events']","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]","[{'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0853715,"Temperature allocation was not associated with bleeding either in the univariable (p = 0.95) or in the primary multivariable analysis (odds ratio [OR] 0.95; 95% confidence interval [CI] 0.64-1.41,","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kander', 'Affiliation': 'Department of Clinical Sciences, Anesthesia and Intensive Care, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden-Forum South Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Schött', 'Affiliation': 'Department of Clinical Sciences, Anesthesia and Intensive Care, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Rundgren', 'Affiliation': 'Department of Clinical Sciences, Anesthesia and Intensive Care, Skane University Hospital, Lund University, Lund, Sweden.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2018.0024']
971,30377243,Evidence of compensation among waterpipe smokers using harm reduction components.,"OBJECTIVES


We examined two waterpipe tobacco smoking components advertised to reduce harm to determine if they result in lower levels of biomarkers of acute exposure.
METHODS


We conducted a crossover study of 34 experienced waterpipe smokers smoking a research-grade waterpipe in three configurations  ad libitum  in a controlled chamber: control (quick-light charcoal), electric (electric heating) and bubble diffuser (quick-light charcoal and bubble diffuser). We collected data on smoking topography, environmental carbon monoxide (CO), subjective effects, heart rate, plasma nicotine and exhaled CO and benzene.
RESULTS


Smokers' mean plasma nicotine, heart rate, and exhaled benzene and CO boost were all significantly lower for electric compared with control. However, smokers puffed more intensely and took significantly more and larger volume puffs for a larger total puffing volume (2.0 times larger, p<0.0001) when smoking electric; machine yields indicate this was likely due to lower mainstream nicotine. Smokers rated electric smoking experience less satisfying and less pleasant. For charcoal heating, the mean mass of CO emitted into the chamber was ~1 g when participants smoked for a mean of 32 minutes at a typical residential ventilation rate (2.3 hr -1 ).
CONCLUSION


Waterpipe smokers engaged in compensation (i.e., increased and more intense puffing) to make up for decreased mainstream nicotine delivery from the same tobacco heated two ways. Waterpipe components can affect human puffing behaviours, exposures and subjective effects. Evidence reported here supports regulation of waterpipe components, smoking bans in multifamily housing and the use of human studies to evaluate modified or reduced risk claims.",2020,"RESULTS


Smokers' mean plasma nicotine, heart rate, and exhaled benzene and CO boost were all significantly lower for electric compared with control.",['34 experienced waterpipe smokers smoking a research-grade waterpipe in three configurations  ad'],"['libitum  in a controlled chamber: control (quick-light charcoal), electric (electric heating) and bubble diffuser (quick-light charcoal and bubble diffuser']","['typical residential ventilation rate', 'mean plasma nicotine, heart rate, and exhaled benzene and CO boost', 'smoking topography, environmental carbon monoxide (CO), subjective effects, heart rate, plasma nicotine and exhaled CO and benzene']","[{'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0035168'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0018851', 'cui_str': 'Heating'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0053291', 'cui_str': 'benzyl chloride'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",34.0,0.0136421,"RESULTS


Smokers' mean plasma nicotine, heart rate, and exhaled benzene and CO boost were all significantly lower for electric compared with control.","[{'ForeName': 'Marielle C', 'Initials': 'MC', 'LastName': 'Brinkman', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Hyoshin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Battelle Public Health Center for Tobacco Research, Battelle, Seattle, Washington, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Buehler', 'Affiliation': 'Battelle Public Health Center for Tobacco Research, Battelle, Columbus, Ohio, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Adetona', 'Affiliation': 'Battelle Public Health Center for Tobacco Research, Battelle, Columbus, Ohio, USA.'}, {'ForeName': 'Sydney M', 'Initials': 'SM', 'LastName': 'Gordon', 'Affiliation': 'Battelle Public Health Center for Tobacco Research, Battelle, Columbus, Ohio, USA.'}, {'ForeName': 'Pamela I', 'Initials': 'PI', 'LastName': 'Clark', 'Affiliation': 'School of Public Health, Tobacco Center of Regulatory Science, University of Maryland, College Park, Maryland, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054502']
972,29261439,Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012.,"Purpose To determine whether cotargeting poly (ADP-ribose) polymerase-1 plus androgen receptor is superior to androgen receptor inhibition in metastatic castration-resistant prostate cancer (mCRPC) and whether ETS fusions predict response. Patients and Methods Patients underwent metastatic site biopsy and were stratified by ETS status and randomly assigned to abiraterone plus prednisone without (arm A) or with veliparib (arm B). Primary objectives were: confirmed prostate-specific antigen (PSA) response rate (RR) and whether ETS fusions predicted response. Secondary objectives were: safety, measurable disease RR (mRR), progression-free survival (PFS), and molecular biomarker analysis. A total of 148 patients were randomly assigned to detect a 20% PSA RR improvement. Results A total of 148 patients with mCRPC were randomly assigned: arm A, n = 72; arm B, n = 76. There were no differences in PSA RR (63.9% v 72.4%; P = .27), mRR (45.0% v 52.2%; P = .51), or median PFS (10.1 v 11 months; P = .99). ETS fusions did not predict response. Exploratory analysis of tumor sequencing (80 patients) revealed: 41 patients (51%) were ETS positive, 20 (25%) had DNA-damage repair defect (DRD), 41 (51%) had AR amplification or copy gain, 34 (43%) had PTEN mutation, 33 (41%) had TP53 mutation, 39 (49%) had PIK3CA pathway activation, and 12 (15%) had WNT pathway alteration. Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors. Median PFS was longer in patients with normal PTEN (13.5 v 6.7 months; P = .02), TP53 (13.5 v 7.7 months; P = .01), and PIK3CA (13.8 v 8.3 months; P = .03) versus those with mutation or activation. In multivariable analysis adjusting for clinical covariates, DRD association with PFS remained significant. Conclusion Veliparib and ETS status did not affect response. Exploratory analysis identified a novel DRD association with mCRPC outcomes.",2018,"Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors.","['tumor sequencing (80 patients) revealed: 41 patients (51%) were ETS positive, 20 (25%) had DNA-damage repair defect ', 'Metastatic Castration-Resistant Prostate Cancer', 'Patients and Methods Patients underwent metastatic site biopsy and were stratified by ETS status and randomly assigned to', '148 patients', '148 patients with mCRPC', 'metastatic castration-resistant prostate cancer (mCRPC']","['abiraterone plus prednisone without (arm A) or with veliparib (arm B', 'cotargeting poly (ADP-ribose) polymerase-1 plus androgen receptor']","['PSA RR', 'PIK3CA pathway activation', 'TP53', 'safety, measurable disease RR (mRR), progression-free survival (PFS), and molecular biomarker analysis', 'AR amplification or copy gain', 'confirmed prostate-specific antigen (PSA) response rate (RR) and whether ETS fusions predicted response', 'mRR', 'longer median PFS', 'median PFS', 'Median PFS']","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C4082864', 'cui_str': 'NAD+ ADP-ribosyltransferase-1'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",148.0,0.310998,"Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors.","[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daignault-Newton', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Przemyslaw W', 'Initials': 'PW', 'LastName': 'Twardowski', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Costantine', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Stein', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Lakshmi P', 'Initials': 'LP', 'LastName': 'Kunju', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Siddiqui', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Yi-Mi', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Lonigro', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Tomlins', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Cooney', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Montgomery', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Young E', 'Initials': 'YE', 'LastName': 'Whang', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Caram', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Knudsen', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Arul M', 'Initials': 'AM', 'LastName': 'Chinnaiyan', 'Affiliation': 'Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University; Walter M. Stadler, University of Chicago, Chicago; Daniel H. Shevrin, NorthShore University Health System, Evanston, IL; Maha Hussain, Stephanie Daignault-Newton, Lakshmi P. Kunju, Javed Siddiqui, Yi-Mi Wu, Dan Robinson, Robert J. Lonigro, Xuhong Cao, Scott A. Tomlins, Rohit Mehra, David C. Smith, Megan V. Caram, and Arul M. Chinnaiyan, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Przemyslaw W. Twardowski, City of Hope Cancer Center, Duarte; Felix Y. Feng, University of California San Francisco, San Francisco, CA; Costantine Albany, Simon Cancer Center, Indiana University, Indianapolis, IN; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Kathleen A. Cooney, University of Utah, Salt Lake City, UT; Bruce Montgomery, University of Washington, Seattle, WA; Emmanuel S. Antonarakis, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Paul G. Corn, University of Texas MD Anderson Cancer Center, Houston, TX; Young E. Whang, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Karen E. Knudsen, Thomas Jefferson University, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.75.7310']
973,31676258,Application of enhanced recovery after surgery during the perioperative period in infants with Hirschsprung's disease - A multi-center randomized clinical trial.,"BACKGROUND & AIMS


Various enhanced recovery after surgery (ERAS) guidelines have been established for several kinds of adult surgeries. While the guidelines for pediatric surgeries remained to be explored. The aim of the study was to prospectively evaluate the safety and efficacy of an ERAS protocol for Hirschsprung's disease (HSCR) infants undergoing pull-through procedures.
METHODS


An infant-specific ERAS protocol was developed and implemented at multiple centers from June 1, 2016 to December 31, 2017. The study included 145 consecutive patients who underwent pull-through surgery for HSCR in three Children's hospitals. Patients were primarily divided into three groups based on the clinical classification and surgical methods. Group I included patients with the short segment type who received transanal endorectal pull-through (TEPT) surgery. Group II comprised of patients with the classical type and long segment type who received laparoscopic-assisted pull-through (LAPT) surgery. Group III involved patients with the long segment type (who had received ileostomy or colostomy during the neonatal period) and total colonic aganglionosis who received open pull-through (OPPT) surgery. Patients in the three groups mentioned above were randomly and equally assigned into the ERAS group and traditional (TRAD) group with random number table row randomization. The primary outcome was the length of postoperative hospital stay (LOS). Secondary outcomes of interest included white blood cell (WBC) and C-reactive protein (CRP) on postoperative day 1 (POD 1), the blood glucose at the time of anesthesia and 24 h after surgery, time to first defecation, time to regular diet, plasma markers of nutrition status on POD 5, plasma natrium on POD 5, the mean intraoperative fluid volume, time to discontinuation of intravenous infusion, incidence of postoperative complications, re-admission within 30 days, hospitalization costs, parental satisfaction, and growth from admission to 6 months after surgery.
RESULTS


73 and 75 patients were assigned to the TRAD and ERAS groups, respectively. There were no significant differences in demographic data. The LOS decreased from 9.5 days in the TRAD group to 7.9 days (P < 0.001) in the ERAS group. WBC count on POD 1 showed no significant difference between the two groups. CRP on POD 1 in the ERAS group was significantly lower (P < 0.001). In the ERAS group, the blood glucose was higher at anesthesia compared to the TRAD group (P < 0.001). On the contrary, the blood glucose at 24 h after surgery was significantly lower in the ERAS group (P < 0.001). Intraoperative fluid volume was lower in the EARS group (P < 0.001). ERAS could also reduce the time to first defecation (P < 0.001), discontinuation of intravenous infusion (P < 0.001) and regular diet (P < 0.001). In the ERAS group, the concentrations of prealbumin and retinol conjugated protein on POD 5 were higher than those in the TRAD group (P < 0.001, P < 0.001, respectively). The plasma natrium had no difference in the two groups on POD 5 (P > 0.05). The rate of complications (P > 0.05) and 30-day re-admission (P > 0.05) were not significantly different between the two groups. Hospitalization costs were also reduced (P < 0.001). ERAS group has a higher parental satisfaction rate, although there was no statistical difference (96% vs 89%). There was no difference in growth between the ERAS and the TRAD groups from admission to 6 months after the surgery (weight for age z score: P > 0.05, weight for length z score: P > 0.05). We also found that the shortening of LOS by the application of ERAS protocol was more obvious in the OPPT group (-2.5 ± 1.0) than that in the TEPT (-1.9 ± 1.3) and LAPT (-1.3 ± 0.4) groups.
CONCLUSIONS


Implementation of the ERAS protocol in infants undergoing HSCR pull-through operations is safe and efficient. The ERAS protocol is worthy of recommendation.
TRIAL REGISTRATION


Clinical Trials.gov identifier: NCT02776176.",2020,"ERAS group has a higher parental satisfaction rate, although there was no statistical difference (96% vs 89%).","['Group I included patients with the short segment type who received', ""Hirschsprung's disease (HSCR) infants undergoing pull-through procedures"", ""in three Children's hospitals"", 'An infant-specific ERAS protocol was developed and implemented at multiple centers from June 1, 2016 to December 31, 2017', '73 and 75 patients', '145 consecutive patients who underwent', ""infants with Hirschsprung's disease\xa0""]","['ileostomy or colostomy during the neonatal period) and total colonic aganglionosis who received open pull-through (OPPT) surgery', 'transanal endorectal pull-through (TEPT) surgery', 'ERAS', 'TRAD and ERAS', 'TRAD', 'laparoscopic-assisted pull-through (LAPT) surgery', 'pull-through surgery for HSCR', 'ERAS group and traditional (TRAD', 'ERAS protocol']","['demographic data', 'time to first defecation', '30-day re-admission', 'concentrations of prealbumin and retinol conjugated protein on POD', 'Hospitalization costs', 'shortening of LOS', 'parental satisfaction rate', 'WBC count on POD', 'length of postoperative hospital stay (LOS', 'discontinuation of intravenous infusion', 'LOS', 'Intraoperative fluid volume', 'rate of complications', 'white blood cell (WBC) and C-reactive protein (CRP) on postoperative day 1 (POD 1), the blood glucose at the time of anesthesia and 24\xa0h after surgery, time to first defecation, time to regular diet, plasma markers of nutrition status on POD 5, plasma natrium on POD 5, the mean intraoperative fluid volume, time to discontinuation of intravenous infusion, incidence of postoperative complications, re-admission within 30 days, hospitalization costs, parental satisfaction, and growth from admission to 6 months after surgery', 'CRP on POD', 'safety and efficacy', 'blood glucose']","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0019569', 'cui_str': 'Megacolon, Congenital'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0085758', 'cui_str': 'Aganglionosis, Colonic'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",145.0,0.0460963,"ERAS group has a higher parental satisfaction rate, although there was no statistical difference (96% vs 89%).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatric Surgery, Anhui Provincial Children's Hospital, Hefei 230000, China.""}, {'ForeName': 'Tongshen', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Pediatric Surgery, Xuzhou Children's Hospital of Xuzhou Medical University, Xuzhou 221000, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China.""}, {'ForeName': 'Jiexiong', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Pediatric Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China. Electronic address: jiexiongfeng@126.com.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing 210000, China. Electronic address: twbcn@163.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.10.001']
974,31605663,Exercise-induced attenuation of treatment side-effects in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy: a randomised controlled trial.,"OBJECTIVES


(i) To assess whether exercise training attenuates the adverse effects of treatment in patients with newly diagnosed prostate cancer beginning androgen-deprivation therapy (ADT), and (ii) to examine whether exercise-induced improvements are sustained after the withdrawal of supervised exercise.
PATIENTS AND METHODS


In all, 50 patients with prostate cancer scheduled for ADT were randomised to an exercise group (n = 24) or a control group (n = 26). The exercise group completed 3 months of supervised aerobic and resistance exercise training (twice a week for 60 min), followed by 3 months of self-directed exercise. Outcomes were assessed at baseline, 3- and 6-months. The primary outcome was difference in fat mass at 3-months. Secondary outcomes included: fat-free mass, cardiopulmonary exercise testing variables, QRISK ®  2 (ClinRisk Ltd, Leeds, UK) score, anthropometry, blood-borne biomarkers, fatigue, and quality of life (QoL).
RESULTS


At 3-months, exercise training prevented adverse changes in peak O 2  uptake (1.9 mL/kg/min, P = 0.038), ventilatory threshold (1.7 mL/kg/min, P = 0.013), O 2  uptake efficiency slope (0.21, P = 0.005), and fatigue (between-group difference in Functional Assessment of Chronic Illness Therapy-Fatigue score of 4.5 points, P = 0.024) compared with controls. After the supervised exercise was withdrawn, the differences in cardiopulmonary fitness and fatigue were not sustained, but the exercise group showed significantly better QoL (Functional Assessment of Cancer Therapy-Prostate difference of 8.5 points, P = 0.034) and a reduced QRISK2 score (-2.9%, P = 0.041) compared to controls.
CONCLUSION


A short-term programme of supervised exercise in patients with prostate cancer beginning ADT results in sustained improvements in QoL and cardiovascular events risk profile.",2020,A short-term programme of supervised exercise for prostate cancer patients beginning ADT results in sustained improvements in QoL and cardiovascular event risk profile.,"['newly diagnosed prostate cancer patients beginning androgen deprivation therapy', 'Fifty prostate cancer patients scheduled for ADT', 'prostate cancer patients beginning ADT', 'newly diagnosed prostate cancer patients beginning androgen deprivation therapy (ADT), and 2']","['exercise group', 'Exercise-induced attenuation', 'exercise training', 'supervised aerobic and resistance exercise training', 'supervised exercise']","['fat-free mass, cardiopulmonary exercise testing variables, QRISK2 score, anthropometry, blood-borne biomarkers, fatigue, and quality of life (QoL', 'fat mass', 'ventilatory threshold', 'cardiopulmonary fitness and fatigue', 'higher QoL', 'reduced QRISK2 score', 'oxygen uptake efficiency slope', 'QoL and cardiovascular event risk profile', 'adverse changes in peak oxygen uptake', 'fatigue']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.140773,A short-term programme of supervised exercise for prostate cancer patients beginning ADT results in sustained improvements in QoL and cardiovascular event risk profile.,"[{'ForeName': 'Wilphard', 'Initials': 'W', 'LastName': 'Ndjavera', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Orange', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alasdair F', 'Initials': 'AF', 'LastName': ""O'Doherty"", 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, College of Healthcare Sciences, James Cook University, Townsville, QLD, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rochester', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mills', 'Affiliation': 'Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Saxton', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}]",BJU international,['10.1111/bju.14922']
975,29746337,Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II).,"OBJECTIVE


The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer.
SUMMARY BACKGROUND DATA


Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery.
METHODS


Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years. Primary endpoint was local recurrence at 3-year follow-up. Secondary endpoints included bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints.
RESULTS


All 1044 patients included in the COLOR II trial were analyzed. There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer.
CONCLUSION


Based on long-term morbidity outcomes, laparoscopic surgery for rectal cancer could be considered a routine technique as there are no differences with open surgery.",2019,"There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer.
","['All 1044 patients included in the COLOR II trial were analyzed', 'Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years']","['Laparoscopic Versus Open Surgery', 'laparoscopic versus open surgery', 'laparoscopic surgery']","['local recurrence', 'bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints', 'Bowel Obstruction and Ventral Hernia', 'risk of bowel obstruction, incisional, and parastomal hernia', 'risk of bowel obstruction, incisional, or parastomal hernia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019326', 'cui_str': 'Ventral Hernia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1044.0,0.34583,"There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer.
","[{'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Petersson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University, Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Koedam', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'H Jaap', 'Initials': 'HJ', 'LastName': 'Bonjer', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University, Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Angenete', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University, Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bock', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University, Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Deijen', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Fürst', 'Affiliation': 'Department of Surgery, Caritas Krankenhaus St Josef Regensburg, Regensburg, Germany.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Lacy', 'Affiliation': 'Department of Surgery, Hospital Clínic Universitari, Barcelona, Spain.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University, Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000002790']
976,31639246,Downregulation of S100a7a antimicrobial peptide in acne vulgaris patients after isotretinoin therapy.,"The S100a7a protein is expressed in keratinocytes, its level is increased in acne condition. As isotretinoin therapy is known to alter some of S100 peptides, these could be important specific targets for acne therapy and may have an important role in clinical remission. A randomized controlled trial was held in a dermatology clinic in Baghdad, where 30 patients with moderate to severe acne vulgaris condition aged 16-31 years were enrolled. Five milliliters of venous blood samples were taken before and after 6 weeks of isotretinoin therapeutic trial. A placebo-control group of 26 acne patients was also enrolled. The S100a7a peptide was measured in both groups using the ELISA technique before and after the trial. High levels of serum S100a7a were found in acne patients of both groups before therapeutic trial. Following the trial, a significant statistical difference (p = .0003) was noticed between mean S100a7a protein level of study and control groups. By comparing the mean S100a7a protein level before and after isotretinoin therapy in the study group, a highly significant statistical difference was also found (p = .001). The current study showed a downregulatory effect of isotretinoin therapy on the S100a7a peptide mean level.",2019,"Following the trial, a significant statistical difference (P= 0.0003) was noticed between mean S100a7a protein level of study and control groups.","['acne vulgaris patients after isotretinoin therapy', '26 acne patients', '30 patients with moderate to severe acne vulgaris condition aged 16-31\u2009years were enrolled']","['placebo', 'S100a7a antimicrobial peptide', 'isotretinoin therapy']",['mean S100a7a protein level'],"[{'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4510271', 'cui_str': 'Isotretinoin therapy'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C4510271', 'cui_str': 'Isotretinoin therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",26.0,0.0207799,"Following the trial, a significant statistical difference (P= 0.0003) was noticed between mean S100a7a protein level of study and control groups.","[{'ForeName': 'Nameer K', 'Initials': 'NK', 'LastName': 'Al-Sudany', 'Affiliation': 'Department of Dermatology and Venereology, Ibn Sina University of Medical and Pharmaceutical Sciences, Baghdad, Iraq.'}, {'ForeName': 'Nadia H', 'Initials': 'NH', 'LastName': 'Mohammed', 'Affiliation': 'College of Pharmacy, Al-Mustansiriya University, Baghdad, Iraq.'}, {'ForeName': 'Sinan B', 'Initials': 'SB', 'LastName': 'Alrifai', 'Affiliation': 'College of Medicine, Ibn Sina University of Medical and Pharmaceutical Sciences, Baghdad, Iraq.'}]",Dermatologic therapy,['10.1111/dth.13136']
977,30644785,Preoperative Carbohydrate Loading in Gynecological Patients Undergoing Combined Spinal and Epidural Anesthesia.,"Purpose:  Preoperative carbohydrate loading (CHO) could improve insulin sensitivity and promoted postoperative recovery under general anesthesia. The aim of this study was to investigate the effects of CHO on gynecological patients.  Methods : A group of 58 female patients undergoing surgery were randomized to either fast overnight (the FAST group) or receive 800 ml of CHO the evening before and 400 ml 2 h before anesthesia (the CHO group).The perioperative well-being and the nutritional status, as determined by blood samples for three biochemical assays (the base status, the status after the operation, and the status on the first day after the operation), were recorded. The homeostasis model assessment (HOMA-IR) was used to measure perioperative insulin resistance. The primary endpoint was phantom limb syndrome (PLS) induced by combined spinal and epidural anesthesia (CSEA).  Results : The CHO group had significantly lower levels of anxiety ( p  < 0.01), hunger ( p  < 0.01), and thirst ( p  < 0.01); lower incidence of PLS ( p  < 0.01) and abdominal distention ( p  < 0.05); earlier occurrence of first flatus ( p  < 0.01); and fewer hospitalization days ( p  < 0.01) than patients from the FAST group. Biochemical analysis showed that the levels of interleukin-6 (IL-6) ( p  < 0.01), C-reactive protein ( p  < 0.01), cortisol ( p  < 0.01), glucose ( p  < 0.01), insulin ( p  < 0.01), and HOMA-IR ( p  < 0.01) were lower in the CHO patients. Lactate, pyruvate, and lactate/pyruvate ratios for the CHO patients were also lower than those for the FAST patients.  Conclusions : CHO increased perioperative comfort in gynecological patients undergoing CSEA. It also attenuated insulin resistance after the operation and reduced the number of postoperative stress reactions.",2020,"The CHO group had significantly lower levels of anxiety (p < 0.01), hunger (p < 0.01), and thirst (p < 0.01); lower incidence of PLS (p < 0.01) and abdominal distention (p < 0.05); earlier occurrence of first flatus (p < 0.01); and fewer hospitalization days (p < 0.01) than patients from the FAST group.","['gynecological patients', 'gynecological patients undergoing CSEA', 'Gynecological Patients', 'A group of 58 female patients undergoing surgery']","['Undergoing Combined Spinal and Epidural Anesthesia', 'Preoperative carbohydrate loading (CHO', 'fast overnight (the FAST group) or receive 800\u2009ml of CHO the evening before and 400\u2009ml 2\u2009h before anesthesia', 'CHO']","['homeostasis model assessment (HOMA-IR', 'Lactate, pyruvate, and lactate/pyruvate ratios', 'perioperative comfort', 'hospitalization days', 'C-reactive protein', 'levels of anxiety', 'insulin resistance', 'number of postoperative stress reactions', 'incidence of PLS', 'abdominal distention', 'hunger', 'perioperative insulin resistance', 'phantom limb syndrome (PLS) induced by combined spinal and epidural anesthesia (CSEA', 'levels of interleukin-6 (IL-6', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0244104', 'cui_str': 'Pyruvate'}, {'cui': 'C0428617', 'cui_str': 'Lactate/pyruvate ratio measurement (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0031315', 'cui_str': 'Phantom Sensation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.0164696,"The CHO group had significantly lower levels of anxiety (p < 0.01), hunger (p < 0.01), and thirst (p < 0.01); lower incidence of PLS (p < 0.01) and abdominal distention (p < 0.05); earlier occurrence of first flatus (p < 0.01); and fewer hospitalization days (p < 0.01) than patients from the FAST group.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2018.1546352']
978,31562043,"Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with maintenance chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma.
METHODS


RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine 25 mg/m 2  on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m 2 , on days 1-28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov, number NCT00339118, and follow-up is ongoing.
FINDINGS


Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive maintenance chemotherapy. Median follow-up was 60·3 months (IQR 32·4-89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6-83·2) with maintenance chemotherapy versus 69·8% (62·2-76·2) without maintenance chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45-1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2-90·9) with maintenance chemotherapy versus 73·7% (65·8-80·1) without (HR 0·52 [95% CI 0·32-0·86]; p=0·0097). Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved.
INTERPRETATION


Adding maintenance chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials.
FUNDING


Fondazione Città della Speranza, Association Léon Berard Enfant Cancéreux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.",2019,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","['Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive', '102 hospitals in 14 countries', 'patients with high-risk rhabdomyosarcoma in future EpSSG trials', 'patients with high-risk rhabdomyosarcoma', 'patients with high-risk rhabdomyosarcoma (RMS 2005', 'patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement']","['Vinorelbine and continuous low-dose cyclophosphamide', 'cyclophosphamide', 'ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine', 'maintenance chemotherapy']","['grade 4 non-haematological toxicity (neurotoxicity', 'survival', 'thrombocytopenia', 'overall survival and toxicity', 'anaemia', '5-year disease-free survival', 'Toxicity', 'grade 3-4 leucopenia', '5-year overall survival', 'grade 3-4 neutropenia', 'inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved', 'disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206656', 'cui_str': 'Embryonal Rhabdomyosarcoma'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0427149', 'cui_str': 'Gait, Drop Foot'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}]",371.0,0.370497,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","[{'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy. Electronic address: gianni.bisogno@unipd.it.""}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': ""Institut d'Hématologie et d'Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego Melcón', 'Affiliation': ""Servicio de Oncología y Hematología Pediatrica, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Paediatric Oncology, Utrecht, Netherlands; Department of Paediatric Oncology, Emma Children's Hospital-Academic Medical Center Amsterdam, Netherlands.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Bicêtre-Hôpitaux Universitaires Paris Sud, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Paediatric and Adolescent Oncology, Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Glosli', 'Affiliation': 'Department of Paediatric Research and Department of Paediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Chisholm', 'Affiliation': 'Children and Young Peoples Unit, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanetti', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Devalck', 'Affiliation': 'Paediatric Haematology and Oncology, Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Ben-Arush', 'Affiliation': ""Joan and Sanford Weill Pediatric Hematology Oncology and Bone Marrow Transplantation Division, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mudry', 'Affiliation': ""University Children's Hospital Brno, Czech Republic.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Ferman', 'Affiliation': 'Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Jenney', 'Affiliation': ""Department of Paediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30617-5']
979,29705216,Effect of minimally invasive endotracheal tube suctioning on physiological indices in adult intubated patients: An open-labelled randomised controlled trial.,"BACKGROUND


Endotracheal tube suctioning (ETS) is one of the most frequent procedures performed by nurses in intensive care units. Nevertheless, some suctioning practices are still being performed that do not provide any benefit for patients.
OBJECTIVES


To investigate the effects of minimally invasive ETS (MIETS) versus routine ETS (RETS) on physiological indices in adult intubated patients.
METHODS


In this single centre parallel randomised controlled, open label trial, 64 adult intubated patients in the four intensive care units of Alzahra University hospital, Isfahan, Iran, were randomly allocated to a MIETS or a RETS group. Physiological indices including systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation were assessed immediately before, immediately after, and 10 min after ETS in both groups. The chi-square test, independent t-test, and repeated measures analysis of variance were used to analyse the data.
RESULTS


Sixty-four patients were randomised and analysed. There were no significant differences in mean heart rate between the both groups across the three time points. However, there was a significant drop in peripheral oxygen saturation across the three time points in the RETS group compared to the MIETS group. Furthermore, there was a significant increase in systolic blood pressure, diastolic blood pressure, and mean arterial pressure across the three time points in the RETS group compared to the MIETS group.
CONCLUSION


The results of this study indicate that the use of MIETS has less effect on the alterations of physiological indices and consequently fewer adverse effects than RETS.",2019,There were no significant differences in mean heart rate between the both groups across the three time points.,"['64 adult intubated patients in the four intensive care units of Alzahra University hospital, Isfahan, Iran', 'adult intubated patients', 'Sixty-four patients']","['Endotracheal tube suctioning (ETS', 'minimally invasive endotracheal tube suctioning', 'minimally invasive ETS (MIETS) versus routine ETS (RETS']","['systolic blood pressure, diastolic blood pressure, and mean arterial pressure', 'systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation', 'mean heart rate', 'peripheral oxygen saturation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",64.0,0.109234,There were no significant differences in mean heart rate between the both groups across the three time points.,"[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Shamali', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark; Intensive Care Unit, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: gezaltoshmal@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinia', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Qom University of Medical Sciences, Moalem Street, 3717978311 Qom, Iran. Electronic address: armak1364@yahoo.com.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Østergaard', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark. Electronic address: boestergaard@health.sdu.dk.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Konradsen', 'Affiliation': 'Karolinska Instituttet, Alfred Nobels Allé 23, 141 52 Huddinge, Sweden. Electronic address: hanne.konradsen@ki.se.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2018.03.007']
980,31564231,"Determining the optimal dose of tenecteplase before endovascular therapy for ischemic stroke (EXTEND-IA TNK Part 2): A multicenter, randomized, controlled study.","BACKGROUND AND HYPOTHESIS


Intravenous thrombolysis with tenecteplase is more effective than alteplase in achieving substantial reperfusion at initial angiographic assessment and improves functional outcome. However, the optimal dose of tenecteplase remains uncertain. We hypothesized that 0.40 mg/kg tenecteplase is superior to 0.25 mg/kg tenecteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy.
STUDY DESIGN


EXTEND-IA TNK part 2 is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale (mRS)≤3 (no upper age limit), absence of contraindications to intravenous thrombolysis, and large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal CT. Patients are randomized to IV tenecteplase at either 0.40 mg/kg (max 40 mg) or 0.25 mg/kg (max 25 mg) prior to thrombectomy.
STUDY OUTCOMES


The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified Treatment In Cerebral Infarction (mTICI) 2b/3, or the absence of retrievable intracranial thrombus. Secondary outcomes include mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) by ≥8 points or reaching 0-1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration: ClinicalTrials.gov NCT03340493.",2020,Secondary outcomes include mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) by ≥8 points or reaching 0-1) at day 3.,[],[],"['death and symptomatic intracerebral hemorrhage', 'mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS', 'reperfusion on the initial catheter angiogram']",[],[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",,0.0902012,Secondary outcomes include mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) by ≥8 points or reaching 0-1) at day 3.,"[{'ForeName': 'Bruce Cv', 'Initials': 'BC', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019879652']
981,30500133,Randomized comparison of two commercial culture media (Cook and Vitrolife) for embryo culture after IMSI.,"OBJECTIVE


A variety of studies randomizing women/cycles or oocytes/embryos has been carried out to compare different culture media for culturing embryos up to cleavage or blastocyst stages showing controversial results. A recent systematic review suggested that data in the literature are insufficient to conclude the best culture medium for embryo quality, pregnancy and implantation. The objective of this study was to evaluate whether there is any difference between two commercial culture media regarding clinical outcomes after IMSI cycles.
METHODS


A total of 120 patients, ≤39 years of age, undergoing ART treatment submitted to the IMSI program were prospectively broken down and randomized into two groups: Group I (Cook media) and Group II (Vitrolife media).
RESULTS


Our data demonstrated that there was no difference using all the media from Cook or all the media from Vitrolife, for culturing embryos till day 2, in the bench incubator at low O2 concentration, in relation to fertilization, embryo quality, pregnancy and implantation rates (p>0.05).
CONCLUSION


Both culture media used, Cook medium and Vitrolife medium, for the IMSI procedure and for later embryo culture with transfer on the second day, are equally effective and can be used depending on the ease and availability of acquisition.",2019,"Both culture media used, Cook medium and Vitrolife medium, for the IMSI procedure and for later embryo culture with transfer on the second day, are equally effective and can be used depending on the ease and availability of acquisition.","['120 patients, ≤39 years of age, undergoing ART treatment submitted to the IMSI program']","['Group I (Cook media) and Group II (Vitrolife media', 'commercial culture media (Cook and Vitrolife']","['relation to fertilization, embryo quality, pregnancy and implantation rates (p>0.05']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",120.0,0.037464,"Both culture media used, Cook medium and Vitrolife medium, for the IMSI procedure and for later embryo culture with transfer on the second day, are equally effective and can be used depending on the ease and availability of acquisition.","[{'ForeName': 'Claudia G', 'Initials': 'CG', 'LastName': 'Petersen', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Mauri', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Vagnini', 'Affiliation': 'Paulista Center for Diagnosis Research and Training, Ribeirao Preto, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Renzi', 'Affiliation': 'Paulista Center for Diagnosis Research and Training, Ribeirao Preto, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Petersen', 'Affiliation': 'Paulista Center for Diagnosis Research and Training, Ribeirao Preto, Brazil.'}, {'ForeName': 'Mariana C', 'Initials': 'MC', 'LastName': 'Matilla', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Comar', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Ricci', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Dieamant', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'João Batista A', 'Initials': 'JBA', 'LastName': 'Oliveira', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ricardo L R', 'Initials': 'RLR', 'LastName': 'Baruffi', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}, {'ForeName': 'Jose G', 'Initials': 'JG', 'LastName': 'Franco', 'Affiliation': 'Human Reproduction Prof. Franco Jr, Ribeirão Preto, Brazil.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20180058']
982,30647445,"Warfarin loading dose guided by pharmacogenetics is effective and safe in cardioembolic stroke patients - a randomized, prospective study.","Warfarin treatment is commonly started with a fixed loading dose that might be associated with an increased risk of bleeding. An individual maintenance dose can then be estimated based on a pharmacogenetic algorithm. Starting treatment with the estimated dose implies a longer time to reach the therapeutic range. Our goal was to compare the safety and efficacy of initiating warfarin treatment with a loading dose guided by pharmacogenetics versus a maintenance dose. The primary endpoint was time in the therapeutic range (TTR) in the first 10 days of treatment. Secondary endpoints were time to the first international normalized ratio (INR) in therapeutic range (2.0-3.0) and occurrence of serious adverse events. Consenting cardioembolic stroke patients were genotyped for CYP2C9 (cytochrome P450 2C9 gene) and VKORC1 (vitamin K epoxide reductase complex, subunit 1 gene) polymorphisms and a maintenance warfarin dose was estimated. Patients were randomized into two groups. The loading dose group (LDG) patients received twice the estimated dose in the first 2 days of treatment. The maintenance dose group (MDG) patients received the estimated dose directly from day one. The TTR in the first 10 days was significantly higher in the LDG than in the MDG (50.5% vs. 38.3%, p = 0.003). The time to the first INR in this range was significantly shorter in the LDG (5.24 vs. 7.3 days). There were no significant differences in the INR above this range or serious adverse events. Warfarin loading dose guided by pharmacogenetics after recent cardioembolic stroke improved the efficacy of warfarin initiation without increasing the risk of adverse events.",2019,There were no significant differences in the INR above this range or serious adverse events.,"['Consenting cardioembolic stroke patients', 'cardioembolic stroke patients']","['Warfarin loading dose guided by pharmacogenetics', 'Warfarin', 'warfarin']","['safety and efficacy', 'time to the first international normalized ratio (INR) in therapeutic range (2.0-3.0) and occurrence of serious adverse events', 'risk of bleeding', 'time in the therapeutic range (TTR', 'INR above this range or serious adverse events']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0525032', 'cui_str': 'INR'}]",,0.041928,There were no significant differences in the INR above this range or serious adverse events.,"[{'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Ruzickova', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic. terez.ruzickova@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sramek', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Kaplan', 'Affiliation': 'Hospital Na Homolce, Department of Clinical Biochemistry, Haematology and Immunology, Laboratory of Molecular Genetics, Prague, Czech Republic.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Kumstyrova', 'Affiliation': 'Hospital Na Homolce, Department of Clinical Biochemistry, Haematology and Immunology, Laboratory of Molecular Genetics, Prague, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Lacinova', 'Affiliation': 'Hospital Na Homolce, Department of Clinical Biochemistry, Haematology and Immunology, Laboratory of Molecular Genetics, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Magerova', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sarbochova', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jaroslava Paulasova', 'Initials': 'JP', 'LastName': 'Schwabova', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Matoska', 'Affiliation': 'Hospital Na Homolce, Department of Clinical Biochemistry, Haematology and Immunology, Laboratory of Molecular Genetics, Prague, Czech Republic.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Tomek', 'Affiliation': 'Department of Neurology, 2nd Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0066-4']
983,30604197,"International multicenter randomized, placebo-controlled phase III clinical trial of β-D-mannuronic acid in rheumatoid arthritis patients.","BACKGROUND


The oral administration of drug β-D-mannuronic acid (M2000) showed a potent therapeutic effect in phase I/II study in rheumatoid arthritis (RA) patients. Here, our aim is to assess the efficacy and safety of this new drug in RA patients under a multinational, randomized placebo-controlled phase III clinical trial.
METHOD


Patients (n = 288) with active disease at baseline and inadequate response to conventional drugs were randomly allocated to three groups; (1) receiving mannuronic acid at a dose of two capsules (500 mg) per day orally for 12 weeks, (2) placebo-controlled, and (3) conventional. The primary endpoints were the America College of Rheumatology 20 response (ACR20), 28-joint disease activity score (DAS28) and Modified Health Assessment Questionnaire-Disability Index (M-HAQ-DI). In addition, the participants were followed-up for safety assessment.
RESULTS


In this phase III trial, after 12 weeks of treatment, there was a significant reduction in ACR20 between mannuronic-treated patients compared to placebo and conventional groups. Moreover, there was a similar significant improvement for DAS28 following mannuronic therapy. The statistical analysis showed a significant reduction in the swollen and tender joint count in mannuronic-treated patients compared with the placebo group. On the other side, mannuronic acid showed no-to-very low adverse events in comparison to placebo.
CONCLUSION


The results of this multinational, phase III clinical trial provided a potent evidence base for the use of β-D-mannuronic acid as a new highly safe and efficient drug in the treatment of RA.",2019,The statistical analysis showed a significant reduction in the swollen and tender joint count in mannuronic-treated patients compared with the placebo group.,"['rheumatoid arthritis patients', 'Patients (n\u2009=\u2009288) with active disease at baseline and inadequate response to conventional drugs', 'RA patients under a multinational, randomized', 'rheumatoid arthritis (RA) patients']","['placebo', 'drug β-D-mannuronic acid (M2000', 'mannuronic acid', 'β-D-mannuronic acid', 'placebo-controlled, and (3) conventional']","['ACR20', 'swollen and tender joint count', 'efficacy and safety', 'DAS28', 'America College of Rheumatology 20 response (ACR20), 28-joint disease activity score (DAS28) and Modified Health Assessment Questionnaire-Disability Index (M-HAQ-DI']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0162988', 'cui_str': 'mannuronic acid'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451209', 'cui_str': 'Modified health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}]",,0.239027,The statistical analysis showed a significant reduction in the swollen and tender joint count in mannuronic-treated patients compared with the placebo group.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezaieyazdi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abid', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'Department of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Soleymani-Salehabadi', 'Affiliation': 'Department of Rheumatology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Ahmadzadeh', 'Affiliation': 'Department of Rheumatology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Saiedeh', 'Initials': 'S', 'LastName': 'Omidian', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Sadoughi', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Vahidi', 'Affiliation': 'Inflammation and Inflammatory Diseases Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Khodashahi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Zamurrad', 'Affiliation': 'Department of Rheumatology, Pakistan Institute of Medical Sciences, Islamabad, Pakistan.'}, {'ForeName': 'Seyed Shahabeddin', 'Initials': 'SS', 'LastName': 'Mortazavi-Jahromi', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Research Center of Prevention and Epidemiology of Non-Communicable Disease, Departments of Biostatistics and Epidemiology, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ekhtiari', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Nagasaki National Hospital, Sakuragi-cho 6-41, Nagasaki, Japan.'}, {'ForeName': 'Bernd H A', 'Initials': 'BHA', 'LastName': 'Rehm', 'Affiliation': 'Centre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cuzzocrea', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.'}, {'ForeName': 'Antimo', 'Initials': 'A', 'LastName': ""D'Aniello"", 'Affiliation': 'Laboratory of Neurobiology, Zoological Station of Naples ""Anton Dohrn"", Villa Comunale, Naples, Italy.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mirshafiey', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Box: 14155-6446, Tehran, Iran. mirshafiey@tums.ac.ir.'}]",Inflammopharmacology,['10.1007/s10787-018-00557-2']
984,31672329,From mitochondria to healthy aging: The role of branched-chain amino acids treatment: MATeR a randomized study.,"RATIONALE


Malnutrition often affects elderly patients and significantly contributes to the reduction in healthy life expectancy, causing high morbidity and mortality. In particular, protein malnutrition is one of the determinants of frailty and sarcopenia in elderly people.
METHODS


To investigate the role of amino acid supplementation in senior patients we performed an open-label randomized trial and administered a particular branched-chain amino acid enriched mixture (BCAAem) or provided diet advice in 155 elderly malnourished patients. They were followed for 2 months, assessing cognitive performance by Mini Mental State Examination (MMSE), muscle mass measured by anthropometry, strength measure by hand grip and performance measured by the Timed Up and Go (TUG) test, the 30 s Chair Sit to Stand (30-s CST) test and the 4 m gait speed test. Moreover we measured oxidative stress in plasma and mitochondrial production of ATP and electron flux in peripheral blood mononuclear cells.
RESULTS


Both groups improved in nutritional status, general health and muscle mass, strength and performance; treatment with BCAAem supplementation was more effective than simple diet advice in increasing MMSE (1.2 increase versus 0.2, p = 0.0171), ATP production (0.43 increase versus -0.1, p = 0.0001), electron flux (0.50 increase versus 0.01, p < 0.0001) and in maintaining low oxidative stress. The amelioration of clinical parameters as MMSE, balance, four meter walking test were associated to increased mitochondrial function.
CONCLUSIONS


Overall, our findings show that sustaining nutritional support might be clinically relevant in increasing physical performance in elderly malnourished patients and that the use of specific BCAAem might ameliorate also cognitive performance thanks to an amelioration of mitochondria bioenergetics.",2020,"Both groups improved in nutritional status, general health and muscle mass, strength and performance; treatment with BCAAem supplementation was more effective than simple diet advice in increasing MMSE (1.2 increase versus 0.2, p = 0.0171), ATP production (0.43 increase versus -0.1, p = 0.0001), electron flux (0.50 increase versus 0.01, p < 0.0001) and in maintaining low oxidative stress.","['155 elderly malnourished patients', 'senior patients', 'elderly people', 'elderly malnourished patients']","['amino acid supplementation', 'particular branched-chain amino acid enriched mixture (BCAAem) or provided diet advice']","['oxidative stress in plasma and mitochondrial production of ATP and electron flux in peripheral blood mononuclear cells', 'nutritional status, general health and muscle mass, strength and performance', 'electron flux', 'MMSE', 'cognitive performance by Mini Mental State Examination (MMSE), muscle mass measured by anthropometry, strength measure by hand grip and performance measured by the Timed Up and Go (TUG) test', 'physical performance', 'ATP production', 'mitochondrial function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0033268'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0013852', 'cui_str': 'Negatrons'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0031843', 'cui_str': 'function'}]",155.0,0.0402013,"Both groups improved in nutritional status, general health and muscle mass, strength and performance; treatment with BCAAem supplementation was more effective than simple diet advice in increasing MMSE (1.2 increase versus 0.2, p = 0.0171), ATP production (0.43 increase versus -0.1, p = 0.0001), electron flux (0.50 increase versus 0.01, p < 0.0001) and in maintaining low oxidative stress.","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Buondonno', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Sassi', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Carignano', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Dutto', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Ferreri', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Fausto G', 'Initials': 'FG', 'LastName': 'Pili', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Massaia', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Nisoli', 'Affiliation': 'Department of Medical Biotechnology and Translational Medicine, Centre for Study and Research on Obesity, University of Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ruocco', 'Affiliation': 'Department of Medical Biotechnology and Translational Medicine, Centre for Study and Research on Obesity, University of Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Porrino', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ravetta', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Riganti', 'Affiliation': 'Department of Oncology, University of Turin, Italy.'}, {'ForeName': 'Giovanni C', 'Initials': 'GC', 'LastName': 'Isaia', 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': ""D'Amelio"", 'Affiliation': 'Department of Medical Science, Gerontology and Bone Metabolic Diseases, University of Turin, Italy. Electronic address: patrizia.damelio@unito.it.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.10.013']
985,30296635,The effectiveness of a coordinated preventive care approach for healthy ageing (UHCE) among older persons in five European cities: A pre-post controlled trial.,"BACKGROUND


Older persons often have multiple health and social problems and need a variety of health services. A coordinated preventive approach that integrates the provision of health and social care services could promote healthy ageing. Such an approach can be organised differently, depending on the availability and organizational structures in the local context. Therefore, it is important to evaluate the effectiveness of a coordinated preventive care approach in various European settings.
OBJECTIVES


This study explored the effects of a coordinated preventive health and social care approach on the lifestyle, health and quality of life of community-dwelling older persons in five European cities.
DESIGN


International multi-center pre-post controlled trial.
SETTING


Community settings in cities in the United Kingdom, Greece, Croatia, the Netherlands and Spain.
PARTICIPANTS


1844 community-dwelling older persons (mean age = 79.5; SD = 5.6).
METHODS


The Urban Health Centres Europe (UHCE) approach consisted of a preventive multidimensional health assessment and, if a person was at-risk, coordinated care-pathways targeted at fall risk, appropriate medication use, loneliness and frailty. Intervention and control sites were chosen based on their location in distinct neighbourhoods in the participating cities. Persons in the catchment area of the intervention sites 'the intervention group' received the UHCE approach and persons in catchment areas of the control sites 'the control group' received care as usual. A questionnaire and two measurements were taken at baseline and at one-year follow-up to assess healthy lifestyle, fall risk, appropriate medication use, loneliness level, frailty, level of independence, health-related quality of life and care use. To evaluate differences in outcomes between intervention group and control group for the total study population, for those who received follow-up care-pathways and for each city separately (multilevel) logistic and linear regression analyses were used.
RESULTS


Persons in the intervention group had less recurrent falls (OR = 0.65, 95% CI = 0.48; 0.88) and lower frailty (B=-0.43, 95% CI= -0.65 to -0.22) at follow-up compared with persons in the control group. Physical health-related quality of life and mental well-being was better (B = 0.95; 95% CI = 0.14-1.76; and B = 1.50; 95% CI = 0.15-2.84 respectively). The effects of the UHCE approach were stronger in the subgroup of persons (53.6%) enrolled in care-pathways.
CONCLUSIONS


Our study found promising but minor effects for the use of a coordinated preventive health and social care approach for the promotion of healthy ageing of older persons. Future studies should further evaluate effects of coordinated preventive health and social care aimed at healthy ageing.
TRIAL REGISTRATION


ISRCTN registry number is ISRCTN52788952. Date of registration is 13/03/2017.",2018,"RESULTS


Persons in the intervention group had less recurrent falls (OR = 0.65, 95% CI = 0.48; 0.88) and lower frailty (B=-0.43, 95% CI= -0.65 to -0.22) at follow-up compared with persons in the control group.","['healthy ageing (UHCE) among older persons in five European cities', 'Community settings in cities in the United Kingdom, Greece, Croatia, the Netherlands and Spain', 'community-dwelling older persons in five European cities', '1844 community-dwelling older persons (mean age\u2009=\u200979.5; SD\u2009=\u20095.6', 'subgroup of persons (53.6%) enrolled in care-pathways', 'The Urban Health Centres Europe (UHCE) approach consisted of a', 'Older persons', 'healthy ageing of older persons']","[""UHCE approach and persons in catchment areas of the control sites 'the control group' received care as usual"", 'preventive multidimensional health assessment', 'coordinated preventive care approach', 'coordinated preventive health and social care approach']","['lifestyle, health and quality of life', 'recurrent falls', 'lower frailty', 'healthy lifestyle, fall risk, appropriate medication use, loneliness level, frailty, level of independence, health-related quality of life and care use', 'Physical health-related quality of life and mental well-being']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C4277527', 'cui_str': 'Preventive Care'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0033109', 'cui_str': 'Preventive Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4048230', 'cui_str': 'Level of loneliness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}]",1844.0,0.0413996,"RESULTS


Persons in the intervention group had less recurrent falls (OR = 0.65, 95% CI = 0.48; 0.88) and lower frailty (B=-0.43, 95% CI= -0.65 to -0.22) at follow-up compared with persons in the control group.","[{'ForeName': 'Carmen B', 'Initials': 'CB', 'LastName': 'Franse', 'Affiliation': 'Erasmus University Medical Center, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'van Grieken', 'Affiliation': 'Erasmus University Medical Center, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Alhambra-Borrás', 'Affiliation': 'Polibienestar Research Institute, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Valía-Cotanda', 'Affiliation': 'Polibienestar Research Institute, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'van Staveren', 'Affiliation': 'Zorg Op Noord, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Tasos', 'Initials': 'T', 'LastName': 'Rentoumis', 'Affiliation': 'Alliance for integrated care, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Markaki', 'Affiliation': 'Alliance for integrated care, Athens, Greece.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Bilajac', 'Affiliation': 'Faculty of Medicine University of Rijeka, Department of Social Medicine and Epidemiology, Rijeka, Croatia; Teaching institute of Public Health Primorsko-goranska County, Branch Office Opatija, Rijeka, Croatia.'}, {'ForeName': 'Vanja Vasiljev', 'Initials': 'VV', 'LastName': 'Marchesi', 'Affiliation': 'Faculty of Medicine University of Rijeka, Department of Social Medicine and Epidemiology, Rijeka, Croatia; Faculty of Health Studies, University of Rijeka, Department of Public Health, Rijeka, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Rukavina', 'Affiliation': 'Faculty of Medicine University of Rijeka, Department of Social Medicine and Epidemiology, Rijeka, Croatia; Teaching institute of Public Health Primorsko-goranska County, Branch Office Opatija, Rijeka, Croatia.'}, {'ForeName': 'Arpana', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Manchester Urban Collaboration on Health, Centre for Epidemiology, Division of Population Health, Health Services Research and Primary Care, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'Manchester Urban Collaboration on Health, Centre for Epidemiology, Division of Population Health, Health Services Research and Primary Care, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Koppelaar', 'Affiliation': 'Rotterdam University of Applied Sciences, Research Centre Innovation in Care, Rotterdam, The Netherlands.'}, {'ForeName': 'Rens', 'Initials': 'R', 'LastName': 'Martijn', 'Affiliation': 'Rotterdam University of Applied Sciences, Research Centre Innovation in Care, Rotterdam, The Netherlands.'}, {'ForeName': 'Antonius J J', 'Initials': 'AJJ', 'LastName': 'Voorham', 'Affiliation': 'Rotterdam University of Applied Sciences, Research Centre Innovation in Care, Rotterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mattace Raso', 'Affiliation': 'Erasmus University Medical Center, Section of geriatric medicine, Department of Internal Medicine, Rotterdam, The Netherlands.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcés-Ferrer', 'Affiliation': 'Polibienestar Research Institute, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Raat', 'Affiliation': 'Erasmus University Medical Center, Department of Public Health, Rotterdam, The Netherlands. Electronic address: h.raat@erasmusmc.nl.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2018.09.006']
986,31658975,Redefining Hypoglycemia in Clinical Trials: Validation of Definitions Recently Adopted by the American Diabetes Association/European Association for the Study of Diabetes.,"OBJECTIVE


To determine if the International Hypoglycaemia Study Group (IHSG) level 2 low glucose definition can identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials.
RESEARCH DESIGN AND METHODS


A post hoc analysis was performed of the SWITCH (SWITCH 1:  n  = 501, type 1 diabetes; SWITCH 2:  n  = 721, type 2 diabetes) and DEVOTE ( n  = 7,637, type 2 diabetes) trials utilizing the IHSG low glucose definitions. Patients in all trials were randomized to either insulin degludec or insulin glargine 100 units/mL. In the main analysis, the following definitions were compared:  1 ) American Diabetes Association (ADA) 2005 (plasma glucose [PG] confirmed ≤3.9 mmol/L with symptoms); and  2 ) IHSG level 2 (PG confirmed <3.0 mmol/L, independent of symptoms).
RESULTS


In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed. Similar results were observed for the SWITCH 1 trial. In SWITCH 2, the IHSG level 2 definition produced a rate ratio that was lower than the ADA 2005 definition.
CONCLUSIONS


The IHSG level 2 definition was validated in a series of clinical trials, demonstrating its ability to discriminate between basal insulins. This definition is therefore recommended to be uniformly adopted by regulatory bodies and used in future clinical trials.",2020,"In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed.",[],"['IHSG low glucose definitions', 'insulin degludec or insulin glargine 100 units/mL', 'Insulin Degludec versus Insulin Glargine']","['rate ratio', 'IHSG level 2 (glucose', 'rate ratios of hypoglycemic events']",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",2005.0,0.0568146,"In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed.","[{'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Oncology & Metabolism, University of Sheffield, Sheffield, U.K. s.heller@sheffield.ac.uk.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ratner', 'Affiliation': 'Division of Endocrinology and Metabolism, Georgetown University Medical School, Washington, DC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Seaquist', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bardtrum', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Charlotte Thim', 'Initials': 'CT', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Tutkunkardas', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Moses', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, NJ.'}]",Diabetes care,['10.2337/dc18-2361']
987,30261805,Telementoring for improving primary care provider knowledge and competence in managing chronic pain: A randomised controlled trial.,"Introduction


Primary care providers are frequently unprepared to manage chronic pain adequately due in part to insufficient professional training. This study evaluated the effect of a telementoring intervention on knowledge and perceived competence related to chronic pain management.
Methods


The study design was a cluster randomised controlled trial. Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization. Primary care providers comprised the intervention group (n = 23) and the control group (n = 18). Providers in the intervention group attended telementoring sessions through the TelePain programme and presented patient cases at the beginning and end of their enrolled patients’ 12-week study period. TelePain sessions included a didactic presentation and telementoring for specific patient cases by a panel of pain specialists from the disciplines of pain medicine, internal medicine, anaesthesiology, rehabilitation medicine, psychiatry, addiction medicine, nursing and complementary and integrative pain management. Providers’ baseline and end-of-study knowledge and perceived competence in managing chronic pain were assessed by three questionnaires: Knowledge and Attitudes Survey Regarding Pain, the KnowPain-12 and the Perceived Competence Scale.
Results


Knowledge (Z = –0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = –0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group. These providers attended on average 12.5 sessions (range 0–31) while participating in the study.
Discussion


Further research is recommended to establish the effectiveness of this telementoring intervention.",2020,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","['Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization', 'managing chronic pain']","['TelePain programme', 'telementoring intervention', 'TelePain sessions']",[],"[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",[],[],,0.181327,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","[{'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Eaton', 'Affiliation': 'School of Nursing and Health Studies, University of Washington Bothell, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Godfrey', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Langford', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'School of Nursing, University of Washington Seattle, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Tauben', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18802978']
988,30295116,Effects of serotonin depletion and dopamine depletion on bimodal divided attention.,"Objectives:  This study aimed to explore the effects of acute phenylalanine tyrosine depletion (APTD) and acute tryptophan depletion (ATD) on bimodal divided attention. A balanced amino acid mixture (BAL) served as control condition. Methods:  Fifty-three healthy adults (final analyzed sample was  N  = 49, age:  M  = 23.8 years) were randomly assigned to APTD, ATD or BAL in a double-blind, between-subject approach. Divided attention was assessed after 4 h. Blood samples were taken before and 6 h after challenge intake. Results:  Amino acid concentrations following challenge intake significantly decreased (all  P  ≤ 0.01). There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups. Post-hoc comparison of mean RTs (auditory stimuli) showed a significant difference between ATD (RT = 604.0 ms, SD = 56.9 ms) and APTD (RT = 556.4 ms, SD = 54.2 ms;  P  = 0.037), but no RT difference between ATD and BAL or APTD and BAL (RT = 573.6 ms, SD = 45.7 ms). Conclusions:  The results indicate a possible dissociation between the effects of a diminished brain 5-HT and DA synthesis on the performance in a bimodal divided attention task. The difference was exclusively observed within the RT towards auditory signals.",2020,"There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups.",['54 healthy adults (age: M\u2009=\u200923.8 years'],"['serotonin depletion and dopamine depletion', 'acute phenylalanine-tyrosine depletion (APTD) and acute tryptophan depletion (ATD', 'APTD, ATD or BAL', 'balanced amino acid mixture (BAL']","['bimodal divided attention', 'visual stimuli', 'mean reaction time (RT) towards auditory stimuli']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",54.0,0.0337756,"There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Königschulte', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Civai', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hildebrand', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Gaber', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Zepf', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2018.1532110']
989,30806856,Effect of flaxseed poultice compress application on pain and hand functions of patients with hand osteoarthritis.,"INTRODUCTION/OBJECTIVES


This randomized controlled intervention study investigated the effect of flaxseed poultice compress application on pain and hand functions in patients with primary interphalangeal hand osteoarthritis (OA).
METHOD


The study sample consisted of 82 patients who met the inclusion criteria in the Rheumatology Outpatient Clinic at a University Hospital between January 15, 2017, and May 15, 2018. Patients included in the sample groups were selected randomly. Three sample groups were formed: intervention group I (flaxseed poultice compress) (n = 33), intervention group II (hot compress) (n = 29), and control group (n = 20). The interventions were applied once a day for 7 days in a row. These patients also continued their routine pharmacological treatment. descriptive characteristics identification form, visual analog scale (VAS), Australian-Canadian (AUSCAN) Osteoarthritis (OA) Hand Index, and side effect evaluation form were used as data collection tools.
RESULTS


The means of VAS scores of patients in the intervention group I were 6.03 ± 0.25 on day 0, 2.2 ± 0.30 on day 8, and 3.39 ± 0.32 on day 15. The means of AUSCAN total scores of patients in the intervention group I were 40.84 ± 1.76 on day 0, 14.03 ± 1.66 on day 8, and 15.78 ± 1.66 on day 15. The present study showed that pain significantly decreased and the hand function efficiency increased in patients treated with flaxseed poultice compress compared with the hot compress and control groups.
CONCLUSIONS


In addition to pharmacological treatment, flaxseed poultice compress intervention is recommended to be used as a nursing intervention for reducing pain and increasing hand functions for patients with hand OA in cooperation with the physicians and other health professionals.",2019,The means of AUSCAN total scores of patients in the intervention group,"['82 patients who met the inclusion criteria in the Rheumatology Outpatient Clinic at a University Hospital between January 15, 2017, and May 15, 2018', 'patients with hand osteoarthritis', 'patients with hand OA in cooperation with the physicians and other health professionals', 'patients with primary interphalangeal hand osteoarthritis (OA']","['intervention group I (flaxseed poultice compress', 'flaxseed poultice compress application']","['hand function efficiency', 'pain', 'VAS scores', 'pain and hand functions', 'visual analog scale (VAS), Australian-Canadian (AUSCAN) Osteoarthritis (OA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand (disorder)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0023753', 'cui_str': 'Flaxseed'}, {'cui': 'C4551917', 'cui_str': 'Poultice'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]",,0.0185595,The means of AUSCAN total scores of patients in the intervention group,"[{'ForeName': 'Burcu Babadağ', 'Initials': 'BB', 'LastName': 'Savaş', 'Affiliation': 'Department of Nursing, Faculty of Health Science, Eskisehir Osmangazi University, Meşelik Campus, 26480, Eskisehir, Turkey. burcubabadag1@gmail.com.'}, {'ForeName': 'Güler Balcı', 'Initials': 'GB', 'LastName': 'Alparslan', 'Affiliation': 'Department of Nursing, Faculty of Health Science, Eskisehir Osmangazi University, Meşelik Campus, 26480, Eskisehir, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Korkmaz', 'Affiliation': 'Department of Internal Medicine and Rheumatology, School of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey.'}]",Clinical rheumatology,['10.1007/s10067-019-04484-7']
990,30326768,"Impact of a Nurse-Led Health Promotion Intervention in an Aging Population: Results From a Quasi-Experimental Study on the ""Community Health Consultation Offices for Seniors"".","Objective:  The study evaluated the nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO) "" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years).  Method:  With a quasi-experimental design, the CHCO intervention was evaluated on health-related and care needs-related outcomes after 1-year follow-up. Older people who received the intervention were frail, overweight, or were smoking. The comparison group received care as usual. In both groups, similar data were collected on health status, falls and fractures, and care needs. In the intervention group, additional data were collected on biometric measures and health-related behavior.  Results:  The intervention group and the care-as-usual group included 403 seniors and 984 seniors, respectively. Health-related outcomes, behaviors, and biometric measures, remained stable. After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.  Discussion:  The CHCO intervention showed no significant improvement on health-related outcomes or stability in care needs-related outcomes.",2020,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","['With a quasi-experimental design', 'Community Health Consultation Offices for Seniors', 'Aging Population', 'Older people who received the intervention were frail, overweight, or were smoking', 'nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO)"" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years']","['CHCO intervention', 'Nurse-Led Health Promotion Intervention']","['biometric measures and health-related behavior', 'Health-related outcomes, behaviors, and biometric measures']","[{'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0254728,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","[{'ForeName': 'Anne Esther', 'Initials': 'AE', 'LastName': 'Marcus-Varwijk', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Lilian L', 'Initials': 'LL', 'LastName': 'Peters', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of General Practice & Elderly Care Medicine, The Netherlands.'}, {'ForeName': 'Tommy L S', 'Initials': 'TLS', 'LastName': 'Visscher', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Healthy Cities, Zwolle, The Netherlands.'}, {'ForeName': 'Carolien H M', 'Initials': 'CHM', 'LastName': 'Smits', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Adelita V', 'Initials': 'AV', 'LastName': 'Ranchor', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Health Psychology Section, The Netherlands.'}, {'ForeName': 'Joris P J', 'Initials': 'JPJ', 'LastName': 'Slaets', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department Internal Medicine, the Netherlands.'}]",Journal of aging and health,['10.1177/0898264318804946']
991,30373502,Feasibility study by a single-blind randomized controlled trial of self-management of mobility with a gait-speed feedback device by older persons at risk for falling.,"This single-blind randomized pilot study explored feasibility and safety of a self-management fall prevention program, hypothesizing that older persons can comply with this program, while it does not result in more (injurious) falls, or a decrease in mental wellbeing as an adverse effect of being focused on falls prevention. Eighty-six persons, community-dwelling or home for the aged (mean age 80.3 years [SD: 6.3], 56 women (65.1%)) participated. The intervention group measured their gait speed by using the Mobility Feedback Device (MFD) weekly for 6 months. The control group was monitored for the outcomes without an intervention. Change scores involving health perception and mental wellbeing (Medical Outcomes Study 20-item short form (MOS-20)) were compared between groups. Feasibility was assessed by drop-out rate and compliance to measure gait speed. Safety was assessed by fall incidence during follow-up. MOS-20 decreased significantly in the control group ( p  = 0.024) but remained stable in the intervention group. Drop-out rate was low (9.3%), and compliance was good. Fall incidence was the same for both groups ( p  = 0.155). The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.",2020,"The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.","['Eighty-six persons, community-dwelling or home for the aged (mean age 80.3\xa0years', 'older persons', 'older persons at risk for falling', '56 women (65.1%)) participated']","['self-management fall prevention program', 'self-management of mobility with a gait-speed feedback device', 'gait speed by using the Mobility Feedback Device (MFD) weekly for 6\xa0months']","['Fall incidence', 'fall incidence during follow-up. MOS-20', 'Change scores involving health perception and mental wellbeing (Medical Outcomes Study 20-item short form (MOS-20', 'Safety']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",86.0,0.0215836,"The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schoon', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}, {'ForeName': 'Kim T J', 'Initials': 'KTJ', 'LastName': 'Bongers', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2018.1529004']
992,31653779,Does early anterior cruciate ligament reconstruction prevent development of meniscal damage? Results from a secondary analysis of a randomised controlled trial.,"OBJECTIVES


To determine development of new and worsening meniscal damage over 5 years after acute anterior cruciate ligament (ACL) injury comparing rehabilitation plus early ACL reconstruction ('early-ACLR') versus rehabilitation with optional delayed ACL reconstruction ('optional-delayed-ACLR').
METHODS


We used knee MRIs from the only randomised controlled trial in the field including 121 young adults. One musculoskeletal radiologist read baseline and 5-year follow-up images using the Anterior Cruciate Ligament Osteoarthritis Score (ACLOAS). We defined development (ie, new and worsening) of meniscal damage both dichotomously and as a sum score representing severity (based on the reclassified ACLOAS meniscus grades). In the full analysis set, we analysed development of meniscal damage (yes/no) with logistic regression and severity with zero-inflated Poisson regression and adjusted for age, sex and baseline meniscal damage.
RESULTS


Over 5 years, new or worsening meniscal damage developed in 45% of subjects with early-ACLR and in 53% of subjects with optional-delayed-ACLR. The relative risk for development of meniscal damage on knee level was 1.3 (95% CI 0.9 to 1.9) in optional-delayed-ACLR versus early-ACLR. For medial and lateral meniscal damage, respectively, the relative risks were 2.1 (95% CI 1.1 to 3.9) and 1.0 (95% CI 0.6 to 1.5). The mean severity score was 1.5 higher (more severe damage) on knee level in optional-delayed-ACLR versus early-ACLR (95% CI 1.1 to 1.9) among those with meniscal damage at 5 years. For medial and lateral meniscal damage, respectively, the corresponding scores were 1.7 (95% CI 1.2 to 2.5) and 1.1 (95% CI 0.8 to 1.4).
CONCLUSION


A strategy of early-ACLR may reduce development of medial meniscal damage following acute ACL injury. For the lateral meniscus, ACLR seems neither to be protective nor to increase the risk of damage.
TRIAL REGISTRATION NUMBER


ISRCTN 84752559.",2020,The mean severity score was 1.5 higher (more severe damage) on knee level in optional-delayed-ACLR versus early-ACLR (95% CI 1.1 to 1.9) among those with meniscal damage at 5 years.,"['121 young adults', '5 years after acute anterior cruciate ligament (ACL) injury comparing', 'acute ACL injury']","[""rehabilitation plus early ACL reconstruction ('early-ACLR') versus rehabilitation with optional delayed ACL reconstruction ('optional-delayed-ACLR""]","['relative risk for development of meniscal damage on knee level', 'relative risks', 'Anterior Cruciate Ligament Osteoarthritis Score (ACLOAS', 'mean severity score', 'knee level', 'risk of damage']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.148653,The mean severity score was 1.5 higher (more severe damage) on knee level in optional-delayed-ACLR versus early-ACLR (95% CI 1.1 to 1.9) among those with meniscal damage at 5 years.,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Snoeker', 'Affiliation': 'Lund University, Faculty of Medicine, Clinical Sciences Lund, Orthopaedics, Clinical Epidemiology Unit, Lund, Sweden barbara.snoeker@med.lu.se.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Radiology, Universitatsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Lund University, Faculty of Medicine, Clinical Sciences Lund, Orthopaedics, Clinical Epidemiology Unit, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lohmander', 'Affiliation': 'Lund University, Faculty of Medicine, Clinical Sciences Lund, Orthopaedics, Lund, Sweden.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Frobell', 'Affiliation': 'Lund University, Faculty of Medicine, Clinical Sciences Lund, Orthopaedics, Lund, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Lund University, Faculty of Medicine, Clinical Sciences Lund, Orthopaedics, Clinical Epidemiology Unit, Lund, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101125']
993,31655119,Prospective Randomized Study Comparing Myeloablative Unrelated Umbilical Cord Blood Transplantation versus HLA-Haploidentical Related Stem Cell Transplantation for Adults with Hematologic Malignancies.,"In this prospective randomized study, we compared the outcomes of single-unit umbilical cord blood transplantation (UCBT) and unmanipulated haploidentical stem cell transplantation (haplo-SCT) with post-transplantation cyclophosphamide (PTCy) in adults with hematologic malignancies. All patients received a myeloablative conditioning (MAC) regimen consisting of thiotepa, busulfan, and fludarabine, with antithymocyte globulin (ATG) added for UCBT recipients. Nineteen patients were randomized to UCBT and the other 26 to haplo-HSCT. Four patients (15%) allocated to the haplo-HSCT arm lacked a suitable donor and were crossed over to the UCBT arm. Finally, 23 underwent UCBT and 22 underwent haplo-HSCT. The cumulative incidence of neutrophil recovery was 87% at a median of 19 days (range, 13 to 24 days) in the UCBT arm versus 100% at a median of 17 days (range, 13 to 25 days) in the haplo-SCT arm (P = .04). Platelet recovery was 70% at a median of 40 days (range, 18 to 129 days) in the UCBT arm versus 86% at a median of 24 days (range, 12 to 127 days) in the haplo-HCT arm (P = .02). Rates of acute graft-versus-host disease (GVHD) grade II-IV or grade III-IV, overall chronic GVHD, and extensive chronic GVHD in the UCBT and Haplo-SCT arms were 43% versus 36% (P = .8), 9% versus 9% (P = 1), 66% versus 43% (P = .04), and 41% versus 23% (P = .2), respectively. Two-year nonrelapse mortality and relapse in the 2 arms were 52% versus 23% (P = .06) and 17% versus 23% (P = .5), respectively. Two-year disease-free survival, overall survival, and GVHD/relapse-free survival in the 2 arms were 30% versus 54% (P = .2), 35% versus 59% (P = .1), and 17% versus 40% (P = .04), respectively. Our data show that in the context of an MAC regimen, haplo-SCT with PTCy provides improved outcomes compared with ATG-containing single-unit UCBT.",2020,"2-year disease-free, overall and GvHD/relapse-free survival was 30% vs 54% (p = 0.2), 35% vs 59% (p = 0.1) and 17% vs 40% (p = 0.04) for the UCBT and Haplo-SCT cohorts, respectively.","['Nineteen patients', 'adults with hematological malignancies', 'adults with hematologic malignancies']","['myeloablative conditioning (MAC) regimen consisting of thiotepa, busulfan, fludarabine (TBF), adding anti-thymocyte globulin (ATG', 'UCBT', 'Haplo-HSCT', 'single-unit umbilical cord blood (UCBT) and unmanipulated haploidentical stem cell transplant (Haplo-SCT) with postransplant cyclophosphamide (PTCy', 'UCBT and Haplo-HSCT', 'myeloablative unrelated umbilical-cord blood transplant versus HLA-haploidentical related stem cell transplant']","['Platelet recovery', 'cumulative incidence of neutrophil recovery', '2-year non-relapse mortality and relapse', '2-year disease-free, overall and GvHD/relapse-free survival', 'Acute graft-versus-host disease (GvHD) grade II-IV, III-IV, overall chronic GvHD and extensive type']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",,0.09294,"2-year disease-free, overall and GvHD/relapse-free survival was 30% vs 54% (p = 0.2), 35% vs 59% (p = 0.1) and 17% vs 40% (p = 0.04) for the UCBT and Haplo-SCT cohorts, respectively.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sanz', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain; Department of Medicine, University of Valencia, Valencia, Spain. Electronic address: sanz_jai@gva.es.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Montoro', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Solano', 'Affiliation': 'Department of Medicine, University of Valencia, Valencia, Spain; Hematology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Valcárcel', 'Affiliation': 'Hematology Department, Hospital Universitari Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Sampol', 'Affiliation': 'Hematology Department, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Ferrá', 'Affiliation': ""Hematology Department, Institut Català d'Oncologia, Institut de Recerca contra la Leucemia Josep Carreras, Hospital Germans Trias i Pujol, Universidad Autónoma de Barcelona, Badalona, Spain.""}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Parody', 'Affiliation': 'Hematology Department, Instituto Catalán de Oncología-Hospital Duran i Reynals, Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Lorenzo', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ortí', 'Affiliation': 'Hematology Department, Hospital Universitari Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Hernández-Boluda', 'Affiliation': 'Department of Medicine, University of Valencia, Valencia, Spain; Hematology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Aitana', 'Initials': 'A', 'LastName': 'Balaguer-Roselló', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Guerreiro', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carretero', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Guillermo F', 'Initials': 'GF', 'LastName': 'Sanz', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain; Department of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain; Department of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Piñana', 'Affiliation': 'Hematology Department, Hospital Universitari i Politecnic La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Cancer, Instituto Carlos III, Madrid, Spain.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.10.014']
994,31677181,Effect of clomiphene citrate treatment on the Sertoli cells of dysmetabolic obese men with low testosterone levels.,"BACKGROUND


Clomiphene citrate (CC) has been shown to restore the hypothalamic-pituitary-gonadal (HPG) axis by increasing testosterone (T) levels to physiological levels in patients with dysmetabolic conditions such as obesity, metabolic syndrome and type 2 diabetes mellitus (T2DM). However, the data are unclear regarding the effects on Sertoli cell (SC) function.
AIM


To study SC function by assessing Inhibin B (IB) and anti-Mullerian hormone (AMH) levels at baseline and after 3 months of CC treatment.
MATERIALS AND METHODS


This is an ancillary study of a cross-over, randomised, double-blind, placebo-controlled trial performed to evaluate androgen response to CC treatment in dysmetabolic obese subjects with low T levels treated with metformin. We evaluated SC function by assessing IB and AMH levels at baseline and after 3 months of each treatment in ten dysmetabolic obese subjects with low T levels. In all subjects, the influence of the clinical characteristics, metabolic and hormonal baseline parameters on SC and Leydig (LC) function, evaluated respectively with AMH, IB, follicle-stimulating hormone (FSH) and T levels, was tested.
RESULTS


No significant changes were observed for IB and AMH concentrations after each treatment period. Whereas T and oestradiol (E2) levels were shown to be significantly higher in the CC plus metformin phase (CC/Met) only. No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments. However, baseline T, dihydrotestosterone (DHT) and E2 positively affected IB levels during CC/Met therapy (P = .003, P = .038 and P = .049, respectively). Baseline leptin and FSH had a negative (P = 031) and positive (P = .048) respectively role on T levels during CC/Met, as they were statistically significant compared to the placebo period (Plac/Met).
CONCLUSION


Unlike the LC activity, CC was unable to influence SC function, as shown by the lack of IB and AMH serum modifications, thus suggesting an intrinsic nonreversible defect of SC cells in patients with dysmetabolic conditions.",2020,"No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments.","['Sertoli cellsof dysmetabolic obese men with low testosterone levels', 'dysmetabolic obese subjects with low T levels treated with', 'patients with dysmetabolic conditions such as obesity, metabolic syndrome and type 2 diabetes mellitus (T2DM', 'ten dysmetabolic obese subjects with low T levels', 'patients with dysmetabolic conditions']","['Clomiphene citrate (CC', 'clomiphene citrate treatment', 'metformin', 'placebo']","['serum AMH', 'IB and AMH levels', 'T levels', 'T and estradiol (E2) levels', 'Baseline leptin, and FSH', 'IB and AMH concentrations', 'LC activity', 'baseline T, dihydrotestosterone (DHT) andE2 positively affected IB levels', 'Inhibin B (IB) and Anti-Mullerian Hormone (AMH) levels', 'clinical characteristics, metabolic and hormonal baseline parameters on SC and Leydig (LC) function, evaluated respectively with AMH, IB, FSH and T levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038148', 'cui_str': 'Dihydrotestosterone'}, {'cui': 'C0971174', 'cui_str': 'inhibin B'}, {'cui': 'C4048548', 'cui_str': 'Anti-Mullerian hormone level'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0632596,"No clinical, metabolic or hormonal parameters showed significant effects on serum AMH at baseline or after treatments.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Pelusi', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Flaminia', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Baccini', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Triggiani', 'Affiliation': 'Interdisciplinary Department of Medicine, Internal Medicine, Geriatrics, Endocrinology and Rare Diseases, University of Bari, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bartolomeo', 'Affiliation': 'Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.'}, {'ForeName': 'Matteo Domenico', 'Initials': 'MD', 'LastName': 'Carbone', 'Affiliation': 'Institute of Clinical and Hormonal Research, Foggia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Pergola', 'Affiliation': 'Nutrition Outpatient Clinic, Clinical Oncology Unit, University of Bari, Bari, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Di Dalmazi', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Pagotto', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Pasquali', 'Affiliation': 'Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Vito Angelo', 'Initials': 'VA', 'LastName': 'Giagulli', 'Affiliation': 'Outpatients Clinic of Endocrinology and Metabolic Disease, Conversano Hospital, Bari, Italy.'}]",Clinical endocrinology,['10.1111/cen.14122']
995,31653138,"The Effect of Filial Therapy on Depressive Symptoms of Children with Cancer and Their Mother's Depression, Anxiety, and Stress: A Randomized Controlled Trial.","BACKGROUND


Childhood cancer is an overwhelming life event that can completely change the lives of the sufferers and their parents. Todays, advances of medical science have shifted the fetal nature of childhood cancer to chronic one exposing children and their family to behavioral and psychosocial problems. The aim of this study was to investigate the effect of filial therapy on children's depressive symptoms and their mother's stress, anxiety, and depression.
MATERIALS AND METHODS


In this randomized controlled trial, 32 mothers with their children who suffered from cancer were recruited (16 in each group). During a 10-week training sessions, filial therapy group underwent child-parent relation therapy (CPRT). Training sessions were held once a week. Control group received no training and only individual counseling sessions were held for them we needed. Both groups were assessed before and after the intervention using depression, anxiety, and stress questionnaire-21 (DASS-21), children depression inventory (CDI), and Wong-Baker faces pain rating scale (WBFPRS). Sample randomization and data analysis were conducted by using SPSS (version 20) and running independent t-test and chi-square test. P value< 0.05 was set as the significant level.
RESULTS


Mothers in the filial therapy group experienced significant decrease in their level of depression, anxiety, and stress in the posttest (p < 0.001). In contrast to filial therapy group, mothers in the control group did not show an improvement in their level of depression, anxiety, and stress. Moreover, the results of the current investigative showed that depression of children in the filial therapy group significantly reduced at post-test (p < 0.001). On the other hand, the mean of children's depression in the control group remained steady.
CONCLUSION


The findings of the present study revealed that using filial therapy could reduce the depression of children with cancer and their parent's depression, anxiety, and stress. Accordingly, we suggest filial therapy programs as a routine for addressing psychosocial problems of children with cancer and their families.",2019,"In contrast to filial therapy group, mothers in the control group did not show an improvement in their level of depression, anxiety, and stress.","['32 mothers with their children who suffered from cancer were recruited (16 in each group', ""Children with Cancer and Their Mother's Depression, Anxiety, and Stress"", 'children with cancer and their families', ""children's depressive symptoms and their mother's stress, anxiety, and depression""]","['Filial Therapy', 'filial therapy group underwent child-parent relation therapy (CPRT', 'no training and only individual counseling sessions', 'filial therapy']","['level of depression, anxiety, and stress', ""depression of children with cancer and their parent's depression, anxiety, and stress"", 'depression, anxiety, and stress questionnaire-21 (DASS-21), children depression inventory (CDI), and Wong-Baker faces pain rating scale (WBFPRS', 'Depressive Symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",32.0,0.0314874,"In contrast to filial therapy group, mothers in the control group did not show an improvement in their level of depression, anxiety, and stress.","[{'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooshang', 'Initials': 'H', 'LastName': 'Mirzaie', 'Affiliation': 'Department of Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Saeidi Borujeni', 'Affiliation': 'Department of Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazal', 'Initials': 'G', 'LastName': 'Zahed', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Child Mental Health Center, Mofid Children Hospital,Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Akbarzadeh Baghban', 'Affiliation': 'Protemics Research Center, Department of Basic Science, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mirzakhani', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2019.20.10.2935']
996,31557064,Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial.,"PURPOSE


In the multicenter, open-label, phase III FOWARC trial, modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy resulted in a higher pathologic complete response rate than fluorouracil plus radiotherapy in Chinese patients with locally advanced rectal cancer. Here, we report the final results.
METHODS


Adults ages 18 to 75 years with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2  over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m 2  on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS).
RESULTS


In total, 495 patients were randomly assigned to treatment. After a median follow-up of 45.2 months, DFS events were reported in 46, 39, and 46 patients in the fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, and mFOLFOX6 arms. In each arm, the probability of 3-year DFS was 72.9%, 77.2%, and 73.5% ( P  = .709 by the log-rank test), the 3-year probability of local recurrence after R0/1 resection was 8.0%, 7.0%, and 8.3% ( P  = .873 by the log-rank test), and the 3-year overall survival rate was 91.3%, 89.1%, and 90.7% ( P  = .971 by log-rank test), respectively.
CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer. No significant difference in outcomes was found between mFOLFOX6 without radiotherapy and fluorouracil with radiotherapy, which requires additional investigation of the role of radiotherapy in these regimens.",2019,"CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","['Locally Advanced Rectal Cancer', 'Adults ages 18 to 75 years with stage II/III rectal cancer', 'patients with locally advanced rectal cancer', '495 patients', 'Chinese patients with locally advanced rectal cancer']","['fluorouracil with radiotherapy', 'fluorouracil with radiation', 'fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy', 'infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2  over 48 hours) plus radiotherapy', 'infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy', 'fluorouracil plus radiotherapy', 'Without Radiation Versus Fluorouracil Plus Radiation', 'infusional fluorouracil', 'oxaliplatin 85 mg/m 2  on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6', 'Neoadjuvant Modified FOLFOX6']","['3-year overall survival rate', 'probability of 3-year DFS', '3-year probability of local recurrence', '3-year DFS', '3-year disease-free survival (DFS', 'DFS events']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",495.0,0.0663218,"CONCLUSION


mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Daoda', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Xiehe Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""The First People's Hospital, Guangzhou City, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital, Foshan City, People's Republic of China.""}, {'ForeName': 'Zonghai', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhongcheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""General Hospital, Hunan Province, Changsha, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""The First Affiliated Hospital, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Xinhua Hospital, Dongguan, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02309']
997,31862828,Comment on Jakubowicz et al. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care 2019;42:2171-2180.,,2020,,"['Diabetes', 'Patients With Type']",[],['Glycated Hemoglobin and Daily Insulin Dose'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0233596,,"[{'ForeName': 'Ivan E', 'Initials': 'IE', 'LastName': 'Saraiva', 'Affiliation': 'Division of Hospital Medicine, University of Kentucky, Lexington, KY ivansaraiva@uky.edu.'}]",Diabetes care,['10.2337/dc19-1957']
998,30230399,Randomized crossover feasibility trial of helminthic  Trichuris suis  ova versus placebo for repetitive behaviors in adult autism spectrum disorder.,"Objectives:  Inflammatory mechanisms are implicated in the aetiology of autism spectrum disorder (ASD), and use of the immunomodulator  Trichuris suis  Ova (TSO) is a novel treatment approach. This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD. Methods:  A 28-week double-blind, randomised two-period crossover study of TSO versus placebo in ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine. Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500 TSO ova or matching placebo every 2 weeks of each 12-week period. Results:  Large effect sizes for improvement in repetitive behaviours ( d  = 1.0), restricted interests ( d  = 0.82), rigidity ( d  = 0.79) and irritability ( d  = 0.78) were observed after 12 weeks of treatment. No changes were observed in the social-communication domain. Differences between treatment groups did not reach statistical significance. TSO had only minimal, non-serious side effects. Conclusions:  This proof-of-concept study demonstrates the feasibility of TSO for the treatment of ASD, including a favourable safety profile, and moderate to large effect sizes for reducing repetitive behaviours and irritability. Clinicaltrials.gov:  NCT01040221.",2020,"This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.
","['adult autism spectrum disorder', 'Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500', 'ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine', 'adults with ASD']","['TSO', 'TSO ova or matching placebo', 'TSO versus placebo', 'helminthic Trichuris suis ova versus placebo']","['social-communication domain', 'repetitive behaviours, irritability and global functioning', 'rigidity', 'repetitive behaviours and irritability', 'irritability', 'repetitive behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040955', 'cui_str': 'Trichocephalus'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}]",,0.384337,"This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hollander', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Uzunova', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Bonnie P', 'Initials': 'BP', 'LastName': 'Taylor', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Noone', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Doernberg', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Casara Jean', 'Initials': 'CJ', 'LastName': 'Ferretti', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2018.1523561']
999,30168896,Quality of life improvements in patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport ®  ).,"BACKGROUND AND PURPOSE


In patients with cervical dystonia, abobotulinumtoxinA solution for injection (ASI) has been shown to be similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores. In this secondary analysis, quality of life data as evaluated with the Cervical Dystonia Impact Profile (CDIP-58) are presented.
METHODS


This was a double-blind, randomized, active and placebo-controlled study followed by an open-label extension (NCT01261611). In the double-blind phase, patients were randomized (3:3:1) to one cycle of ASI 500 U (n = 156), abobotulinumtoxinA 500 U (n = 159) or placebo (n = 54). Following the double-blind phase, all patients received open-label ASI for up to four cycles.
RESULTS


The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo]. All CDIP-58 domains contributed to this improvement and benefits were maintained across open-label treatment. Positive correlations were observed between CDIP-58 total score and all three TWSTRS domains (R = 0.42-0.62) and for all CDIP-58 subscales with the TWSTRS total score and domains (R = 0.23-0.60).
CONCLUSIONS


Repeat ASI injections are similarly effective to abobotulinumtoxinA in improving patient-reported outcomes of health-related quality of life. Positive correlations were found between TWSTRS total and domain scores and CDIP-58 total and domain scores.",2019,"The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo].","['patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport ®  ', 'patients with cervical dystonia']","['abobotulinumtoxinA 500\xa0U (n\xa0=\xa0159) or placebo', 'abobotulinumtoxinA solution for injection (ASI', 'placebo', 'open-label ASI']","['CDIP-58 total scores', 'CDIP-58 total score', 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores', 'Quality of life improvements', 'TWSTRS total and domain scores and CDIP-58 total and domain scores', 'Cervical Dystonia Impact Profile (CDIP-58', 'quality of life data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991511', 'cui_str': 'Injectable Solution'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.32023,"The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo].","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simonetta-Moreau', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse Pôle Neurosciences Purpan, ToNIC, Université de Toulouse, Inserm, UPS, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}]",European journal of neurology,['10.1111/ene.13800']
1000,30145102,"The impact of Helicobacter pylori infection, eradication therapy and probiotic supplementation on gut microenvironment homeostasis: An open-label, randomized clinical trial.","BACKGROUND


Helicobacter pylori (H. pylori) infection is associated with remodeling of gastric microbiota. However, comprehensive analyses of the impact of H. pylori infection, eradication therapy and probiotic supplementation on gut microbiota are still lacking. We aimed to provide evidence for clinical decision making.
METHODS


Seventy H. pylori-positive and 35 H. pylori-negative patients (group C) were enrolled. H. pylori-positive patients were randomly assigned to group A (14-day bismuth-containing quadruple therapy) and group B (quadruple therapy supplemented with Clostridium butyricum). Stool samples of group A and B were collected on day 0, 14 and 56 while stool samples of group C were collected on day 0. Gut microbiota was investigated by 16S rRNA sequencing.
FINDINGS


The Sobs index (richness estimator) was significantly higher in H. pylori-positive samples than H. pylori-negative samples (p < .05). Several metabolic pathways were more abundant in H. pylori-positive communities while some disease-associated pathways had higher potential in H. pylori-negative community through KEGG pathway analysis. Abundances of most butyrate-producing bacteria significantly decreased, while several detrimental bacteria increased after eradication therapy. Probiotic supplementation was associated with improved gastrointestinal symptoms as well as increased Bacteroidetes:Firmicutes ratio.
INTERPRETATION


While H. pylori infection may not be necessarily detrimental in all patients, eradication of H. pylori was associated with widespread changes in gut microbial ecology and structure. Probiotic supplementation could relieve more gastrointestinal symptoms by inducing alterations in gut microbiota and host immune responses. As such, the decision to eradicate H. pylori should be based on comprehensive analysis of individual patients.",2018,The Sobs index (richness estimator) was significantly higher in H. pylori-positive samples than H. pylori-negative samples (p < .05).,"['Seventy H. pylori-positive and 35 H. pylori-negative patients (group C) were enrolled', 'H. pylori-positive patients']","['probiotic supplementation', 'bismuth-containing quadruple therapy) and group B (quadruple therapy supplemented with Clostridium butyricum', 'Probiotic supplementation']","['Sobs index (richness estimator', 'gastrointestinal symptoms', 'Gut microbiota', 'gut microenvironment homeostasis']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0315063', 'cui_str': 'Clostridium butyricum'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0401805', 'cui_str': 'Estimator (occupation)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]",70.0,0.033111,The Sobs index (richness estimator) was significantly higher in H. pylori-positive samples than H. pylori-negative samples (p < .05).,"[{'ForeName': 'Luyi', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China; Department of Gastroenterology, Xinchang Hospital of Traditional Chinese Medicine of Zhejiang, Shaoxing, China.'}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Sanchuan', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Si', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China. Electronic address: jianmin_si@zju.edu.cn.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang, China. Electronic address: chenshujie77@zju.edu.cn.'}]",EBioMedicine,['10.1016/j.ebiom.2018.08.028']
1001,30021499,Ubiquinol (Reduced Coenzyme Q10) and Cellular Oxygen Consumption in Patients Undergoing Coronary Artery Bypass Grafting.,"Ubiquinol is a fundamental component of cellular metabolism. Low ubiquinol levels have been associated with mortality. This was a substudy of a randomized trial in patients undergoing coronary artery bypass grafting. We drew blood before and after surgery. Ubiquinol or placebo was added to peripheral blood mononuclear cells for oxygen consumption (OCR) measurements. In vivo ubiquinol levels were lower postsurgery compared to presurgery (0.16 μmol/L [quartiles: 0.02-0.39],  P  = .01), although the difference disappeared when adjusting for hemoglobin levels ( P  = .30). There was no difference in presurgical basal (1.0 mL/min/mg [95% confidence interval [CI]: -0.9 to 2.2],  P  = .08) and maximal (0.5 mL/min/mg [95% CI: -4.3 to 7.3],  P  = .56) OCR in cells receiving ubiquinol or placebo. There was a difference in postsurgical basal (1.1 mL/min/mg [95% CI: 0.9-1.6],  P  < .001) and maximal (4.2 mL/min/mg [95% CI: 0.3-7.0],  P  = .01) OCR between the groups. We found no association between ubiquinol and OCR levels (all  P  > .05).",2020,"There was no difference in presurgical basal (1.0 mL/min/mg [95% confidence interval [CI]: -0.9 to 2.2], P = .08) and maximal (0.5 mL/min/mg","['patients undergoing coronary artery bypass grafting', 'Patients Undergoing Coronary Artery Bypass Grafting']","['Ubiquinol or placebo', 'placebo']","['hemoglobin levels', 'postsurgical basal', 'presurgical basal', 'Ubiquinol (Reduced Coenzyme Q10) and Cellular Oxygen Consumption', 'ubiquinol and OCR levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0950189', 'cui_str': 'ubiquinols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0950189', 'cui_str': 'ubiquinols'}, {'cui': 'C0077659', 'cui_str': 'coenzyme Q10, reduced'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",,0.286291,"There was no difference in presurgical basal (1.0 mL/min/mg [95% confidence interval [CI]: -0.9 to 2.2], P = .08) and maximal (0.5 mL/min/mg","[{'ForeName': 'Mathias J', 'Initials': 'MJ', 'LastName': 'Holmberg', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Uber', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Stankovic', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C-Y Oliver', 'Initials': 'CO', 'LastName': 'Chen', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Journal of intensive care medicine,['10.1177/0885066618789114']
1002,29858625,"Moderate consumption of a soluble green/roasted coffee rich in caffeoylquinic acids reduces cardiovascular risk markers: results from a randomized, cross-over, controlled trial in healthy and hypercholesterolemic subjects.","PURPOSE


Coffee is rich in bioactive compounds with health beneficial properties, with green coffee presenting higher phenol content than roasted. We evaluated the effects of regularly consuming realistic amounts of a green/roasted coffee blend on cardiovascular health-related biomarkers.
METHODS


A randomized, cross-over, controlled study was carried out in 25 normocholesterolemic [total cholesterol (TC) < 200 mg/dL] and 27 hypercholesterolemic (TC 200-240 mg/dL) subjects. During 8 weeks, volunteers consumed 6 g/day of soluble green/roasted (35:65) coffee or a control beverage (water or an isotonic drink). Blood pressure, heart rate and body weight were monitored at the end of each intervention, and serum lipids [TC, HDL-C, LDL-C, VLDL-C, triglycerides and phospholipids], cytokines and chemokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, MCP-1, MIP-1β, TNF-α, INF-γ), adhesion molecules (ICAM-1, VCAM-1), and C-reactive protein were measured. Plasma antioxidant capacity (FRAP, ORAC and ABTS methods), and lipid (malondialdehyde, MDA) and protein (carbonyl groups, CG) oxidation were also determined.
RESULTS


Attending to the general lineal model of variance for repeated measures, after the green/roasted coffee intervention significant reductions in TC, LDL-C, VLDL-C and triglycerides levels (p = 0.006, 0.001, 0.003 and 0.017, respectively), and a significant group effect were observed (0.001, < 0.001, 0.019 and 0.027, respectively). Only within the hypercholesterolemic group, attending to the Bonferroni test, the aforementioned lipid parameters were significantly lower after regular green/roasted coffee intake compared to baseline values. Moreover, after the coffee stage, plasma antioxidant capacity improved, according to the increase in ORAC and FRAP values (p < 0.001 and p < 0.001, respectively) and decrease of MDA (p = 0.015) and CG (p < 0.001) levels, without differences between groups. Systolic (p = 0.001) and diastolic (p < 0.001) blood pressure, heart rate (p = 0.035), and body weight (p = 0.017) were reduced in both normo- and hypercholesterolemic groups.
CONCLUSION


Regular consumption of moderate amounts of a soluble green/roasted (35:65) coffee blend may contribute to improve cardiovascular health in moderately hypercholesterolemic people, as reducing serum lipids, blood pressure and body weight effects, as well as increasing plasma antioxidant capacity, have been observed. Moreover, positive influences on blood pressure, body weight, and plasma antioxidant capacity were obtained in the healthy group. Therefore, incorporation of green coffee beans into the coffee brew can be recommended as part of a dietary strategy to protect from cardiovascular disease.",2019,"Moreover, after the coffee stage, plasma antioxidant capacity improved, according to the increase in ORAC and FRAP values (p < 0.001 and p < 0.001, respectively) and decrease of MDA (p = 0.015) and CG (p < 0.001) levels, without differences between groups.","['25 normocholesterolemic [total cholesterol (TC)\u2009<\u2009200\xa0mg/dL] and 27 hypercholesterolemic (TC 200-240\xa0mg/dL) subjects', 'healthy and hypercholesterolemic subjects', 'moderately hypercholesterolemic people']","['soluble green/roasted (35:65) coffee blend', 'volunteers consumed 6\xa0g/day of soluble green/roasted (35:65) coffee or a control beverage (water or an isotonic drink']","['Plasma antioxidant capacity (FRAP, ORAC and ABTS methods), and lipid (malondialdehyde, MDA) and protein (carbonyl groups, CG) oxidation', 'plasma antioxidant capacity', 'cardiovascular health-related biomarkers', 'blood pressure, heart rate', 'diastolic', 'Blood pressure, heart rate and body weight', 'blood pressure, body weight, and plasma antioxidant capacity', 'serum lipids, blood pressure and body weight effects', 'body weight', 'Systolic', 'cardiovascular risk markers', 'ORAC and FRAP values', 'TC, LDL-C, VLDL-C and triglycerides levels', 'MDA', 'serum lipids [TC, HDL-C, LDL-C, VLDL-C, triglycerides and phospholipids], cytokines and chemokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, MCP-1, MIP-1β, TNF-α, INF-γ), adhesion molecules (ICAM-1, VCAM-1), and C-reactive protein', 'cardiovascular health']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0452461', 'cui_str': 'Sports drink (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0045246', 'cui_str': ""6-Benzothiazolesulfonic acid, 2,2'-azinobis(3-ethyl-2,3-dihydro), diammonium salt""}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021761', 'cui_str': 'Interleukin-7'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0482129,"Moreover, after the coffee stage, plasma antioxidant capacity improved, according to the increase in ORAC and FRAP values (p < 0.001 and p < 0.001, respectively) and decrease of MDA (p = 0.015) and CG (p < 0.001) levels, without differences between groups.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Martínez-López', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CSIC), C/José Antonio Nováis 10, 28040, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sarriá', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CSIC), C/José Antonio Nováis 10, 28040, Madrid, Spain. beasarria@ictan.csic.es.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mateos', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CSIC), C/José Antonio Nováis 10, 28040, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bravo-Clemente', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CSIC), C/José Antonio Nováis 10, 28040, Madrid, Spain. lbravo@ictan.csic.es.'}]",European journal of nutrition,['10.1007/s00394-018-1726-x']
1003,29858713,Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder.,"The postsecondary outcomes of individuals with autism spectrum disorder (ASD) are significantly worse than peers with other disabilities. One problem is the lack of empirically-supported transition planning interventions to guide services and help produce better outcomes. We applied an implementation science approach to adapt and modify an evidence-based consultation intervention originally tested with young children called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble et al., The collaborative model for promoting competence and success for students with ASD. Springer, New York, 2012a) and evaluate it for efficacy in a randomized controlled trial for transition-age youth. Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1). Consultant fidelity was high and teacher adherence improved over time, replicating the importance of ongoing teacher coaching.",2018,Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1).,"['students with ASD', 'Students with Autism Spectrum Disorder', 'individuals with autism spectrum disorder (ASD', 'transition-age youth']",['COMPASS'],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],[],,0.107346,Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Ruble', 'Affiliation': 'Department of Educational, School, and Counseling Psychology, University of Kentucky, Lexington, KY, 40506, USA. lisa.ruble@uky.edu.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'McGrew', 'Affiliation': 'Psychology, Indiana-University-Purdue University at Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Toland', 'Affiliation': 'Department of Educational, School, and Counseling Psychology, University of Kentucky, Lexington, KY, 40506, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dalrymple', 'Affiliation': ', Bloomington, USA.'}, {'ForeName': 'Medina', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Department of Educational, School, and Counseling Psychology, University of Kentucky, Lexington, KY, 40506, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Snell-Rood', 'Affiliation': 'Community Health Sciences Division, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3623-9']
1004,31640414,Cardiac reinnervation influences exercise training outcomes in heart transplant patients.,,2020,,['heart transplant patients'],['Cardiac reinnervation influences exercise training'],[],"[{'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],,0.0125029,,"[{'ForeName': 'Claudio Gil S', 'Initials': 'CGS', 'LastName': 'Araújo', 'Affiliation': 'Exercise Medicine Clinic, CLINIMEX, Brazil.'}, {'ForeName': 'Jari A', 'Initials': 'JA', 'LastName': 'Laukkanen', 'Affiliation': 'Faculty of Sports and Health Sciences, University of Jyväskylä, Finland.'}]",European journal of preventive cardiology,['10.1177/2047487319884374']
1005,31267293,Effectiveness of a School Based Smokeless Tobacco Intervention: A Cluster Randomized Trial.,"To assess the effectiveness of intervention in improving knowledge, attitude and perception regarding smokeless tobacco (SLT) use and its harmful effects and intention to quit SLT among school going adolescents. A school-based cluster randomized control trial was carried out in 18 secondary schools targeting male and female students from grades 6 to 10 in Karachi. Primary outcome was knowledge about hazards of smokeless tobacco (SLT) and secondary outcomes were attitude and Perception about hazards of SLT, and intention to quit SLT. We enrolled 738 participants in intervention group and 589 in the control group. Mean score of knowledge significantly improved in intervention as compared to control group (P value < 0.01). Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group. Generalized estimating equations were used to assess the association of factors with knowledge regarding harmful effects of SLT use. Significant predictors of increase in knowledge score were found in children: who had seen any anti SLT messages on social media in the past 30 days, who were getting information regarding harmful effects of SLT use in school or textbooks and who had friends using SLT. A school-based intervention was effective in increasing knowledge regarding the harmful effects of SLT use and intention to quit SLT use among school adolescents. Introduction of such educational programmes on a regular basis in schools or as part of school curriculum can have an impact on reducing prevalence of SLT use.Trial Registration NCT03418506. https://register.clinicaltrials.gov/NCT03418506 .",2019,Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group.,"['school going adolescents', '738 participants in intervention group and 589 in the control group', '18 secondary schools targeting male and female students from grades 6 to 10 in Karachi']",['School Based Smokeless Tobacco Intervention'],"['knowledge about hazards of smokeless tobacco (SLT) and secondary outcomes were attitude and Perception about hazards of SLT, and intention to quit SLT', 'Mean score of knowledge', 'knowledge score', 'Intention to quit']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",738.0,0.0593552,Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group.,"[{'ForeName': 'Shafquat', 'Initials': 'S', 'LastName': 'Rozi', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan. shafquat.rozi@aku.edu.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Zahid', 'Affiliation': 'Department of Surgery, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Roome', 'Affiliation': 'Department of Pathology, Dow University of Health Sciences, University Road, Karachi, 75270, Pakistan.'}, {'ForeName': 'Maryam Pyar Ali', 'Initials': 'MPA', 'LastName': 'Lakhdir', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Sobiya', 'Initials': 'S', 'LastName': 'Sawani', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Razzak', 'Affiliation': 'Department of Pathology, Dow University of Health Sciences, University Road, Karachi, 75270, Pakistan.'}, {'ForeName': 'Zahid Ahmad', 'Initials': 'ZA', 'LastName': 'Butt', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}]",Journal of community health,['10.1007/s10900-019-00689-8']
1006,30204841,The Influence of Side Effect Information Framing on Nocebo Effects.,"BACKGROUND


One contributing factor to the development of nocebo effects is information provided about possible side effects. However, nondisclosure of information can be problematic.
PURPOSE


We assessed whether positively framed side effect information (highlighting likelihood of not experiencing side effects) can reduce nocebo effects compared to negatively framed information (highlighting likelihood of experiencing side effects).
METHODS


One hundred twelve participants took part in research ostensibly assessing the influence of benzodiazepines (actually sham capsules) on anxiety. Participants were randomized to receive a sham capsule with positively or negatively framed information about four side effects, or a no-treatment control condition. Side effect expectations were assessed after information provision. Framed side effects and other unmentioned symptoms were assessed during the session and 24-hr follow-up.
RESULTS


Nocebo effects occurred in symptoms presented as side effects (regardless of framing) during the study session and follow-up (ps < .003). At follow-up, there was also a nocebo effect in other unmentioned symptoms (p = .018). Positive framing reduced side effect symptoms compared with negative framing during the study session (p = .037), but this effect was no longer present at follow-up (p = .53). Side effect expectations did not differ between the framing conditions (p = .14).
CONCLUSIONS


Positive framing reduced side effects short-term, but not at follow-up. Expectations did not differ between negative and positive framing. Nocebo effects appeared to generalize to other unmentioned symptoms over a 24-hr period. Further research is needed to determine whether the initial impact of positive framing can be maintained over time.",2019,"Positive framing reduced side effect symptoms compared with negative framing during the study session (p = .037), but this effect was no longer present at follow-up (p = .53).",['One hundred twelve participants took part in research ostensibly assessing the influence of'],"['sham capsule with positively or negatively framed information about four side effects, or a no-treatment control condition', 'benzodiazepines']","['anxiety', 'side effects', 'Side effect expectations']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0035168'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",112.0,0.150076,"Positive framing reduced side effect symptoms compared with negative framing during the study session (p = .037), but this effect was no longer present at follow-up (p = .53).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Faasse', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Huynh', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, The University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Helfer', 'Affiliation': 'Department of Psychology, Adrian College, Adrian, MI, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay071']
1007,30106328,Effects and mechanisms of differently cued and non-cued motor imagery in people with multiple sclerosis: A randomised controlled trial.,"BACKGROUND


Walking impairment and fatigue are prevalent symptoms in people with multiple sclerosis (PwMS). Motor imagery (MI) with rhythmic auditory cueing improved walking in PwMS, but so far, the underlying mechanisms are not fully explored.
OBJECTIVE


This study investigated the effects and mechanisms of differently cued and non-cued MI on walking, fatigue and quality of life (QoL) in PwMS.
METHODS


A total of 60 PwMS with mild to moderate disability were randomised to music- and verbally cued MI (MVMI), music-cued MI (MMI) or MI. Participants practised cued or non-cued MI of walking for 17 minutes, six times per week for 4 weeks at home. Primary outcomes were walking speed (timed 25-foot walk) and walking distance (6-minute walk test).
RESULTS


A total of 59 participants completed the study. All interventions induced significant improvements in walking speed and distance, while MVMI was superior. After cued MI, fatigue and QoL significantly improved, with greatest changes seen after MVMI. All participants showed high MI ability. Post-intervention, sensorimotor synchronisation (SMS) was significantly more accurate after cued MI.
CONCLUSION


All interventions significantly improved walking. MVMI was superior in improving walking, fatigue and QoL. Results suggest that MI and SMS were mechanisms of action.",2019,"Post-intervention, sensorimotor synchronisation (SMS) was significantly more accurate after cued MI.
","['people with multiple sclerosis (PwMS', '59 participants completed the study', 'people with multiple sclerosis', 'A total of 60 PwMS with mild to moderate disability']","['Motor imagery (MI) with rhythmic auditory cueing', 'MVMI', 'music- and verbally cued MI (MVMI), music-cued MI (MMI) or MI', 'differently cued and non-cued MI', 'differently cued and non-cued motor imagery']","['high MI ability', 'walking', 'walking speed (timed 25-foot walk) and walking distance (6-minute walk test', 'sensorimotor synchronisation (SMS', 'walking, fatigue and quality of life (QoL', 'walking speed and distance, while MVMI', 'cued MI, fatigue and QoL']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",60.0,0.127882,"Post-intervention, sensorimotor synchronisation (SMS) was significantly more accurate after cued MI.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Seebacher', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK/Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Kuisma', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Glynn', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518795332']
1008,30107471,The Effect of Reciprocity Priming on Organ Donor Registration Intentions and Behavior.,"BACKGROUND


Internationally the demand for organ transplants far exceeds the available supply of donated organs.
PURPOSE


We examine if a digital reciprocity prime based on reciprocal altruism can be used to increase organ donor registration intentions and behavior.
METHODS


Four hundred twenty participants (223 females) from England and Scotland aged 18+ who were not currently registered organ donors were randomized by block allocation using a 1:1 ratio to receive either a reciprocity prime or control message. After manipulation, they were asked to indicate their organ donation intentions and whether or not they would like to be taken to an organ donation registration and information page.
RESULTS


In line with our previous work, participants primed with a reciprocity statement reported greater intent to register as an organ donor than controls (using a 7-point Likert scale where higher scores = greater intention; prime mean [SD] = 4.3 [1.6] vs. control mean [SD] = 3.7 [1.4], p ≤ .001, d = 0.4 [95% confidence interval [CI] = 0.21-0.59]). There was again however, no effect on behavior as rates of participants agreeing to receive the donation register web-link were comparable between those primed at 11% (n = 23/210) (95% CI = 7.4-16.0) and controls at 12% (n = 25/210) (95% CI = 8.1-17.1), X2 (1) = 0.09, p = .759.
CONCLUSIONS


Reciprocal altruism appears useful for increasing intention towards joining the organ donation register. It does not, however, appear to increase organ donor behavior.",2019,"There was again however, no effect on behavior as rates of participants agreeing to receive the donation register web-link were comparable between those primed at 11% (n = 23/210) (95% CI = 7.4-16.0) and controls at 12% (n = 25/210) (95% CI = 8.1-17.1), X2 (1) = 0.09, p = .759.
",['Four hundred twenty participants (223 females) from England and Scotland aged 18+ who were not currently registered organ donors'],"['Reciprocity Priming', 'reciprocity prime or control message']","['prime mean [SD', 'Organ Donor Registration Intentions and Behavior']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",420.0,0.18295,"There was again however, no effect on behavior as rates of participants agreeing to receive the donation register web-link were comparable between those primed at 11% (n = 23/210) (95% CI = 7.4-16.0) and controls at 12% (n = 25/210) (95% CI = 8.1-17.1), X2 (1) = 0.09, p = .759.
","[{'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Quigley', 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, UK.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay060']
1009,29952839,Enhanced External Counterpulsation and Recovery From a Plyometric Exercise Bout.,"OBJECTIVE


To analyze the effectiveness of enhanced external counterpulsation (EECP) on recovery from exercise-induced muscle damage (EIMD).
DESIGN


This study followed a crossover, placebo-controlled, counterbalanced design.
PARTICIPANTS


Ten healthy active subjects (7 male; 27 ± 4 years).
INTERVENTIONS


Participants performed a plyometric exercise bout (10 sets of 10 jumps interspersed with 1-minute rests) and were then assigned to recover for 30 minutes with either EECP (cuff pressure = 80 mm Hg) or a Sham intervention (0 mm Hg) immediately after exercise and at 24 hours after exercise. Two weeks later, they repeated the protocol with the other recovery intervention.
MAIN OUTCOME MEASURES


Muscle soreness, creatine kinase (CK) activity, jump performance, and tensiomyographic variables were measured before exercise, and 24 and 48 hours after exercise.
RESULTS


The mean jump height of the plyometric bout did not differ between EECP and Sham (P > 0.05). Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05). No changes were observed in tensiomyographic variables. No significant differences were found between interventions for any of the study outcomes.
CONCLUSIONS


No benefits on recovery from EIMD after a plyometric exercise bout were observed with EECP.",2020,"Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05).",['Ten healthy active subjects (7 male; 27 ± 4 years'],"['enhanced external counterpulsation (EECP', 'placebo', 'EECP (cuff pressure = 80 mm Hg) or a Sham intervention', 'EECP', 'plyometric exercise bout', 'Plyometric Exercise Bout']","['tensiomyographic variables', 'impaired jump performance', 'muscle soreness', 'mean jump height of the plyometric bout', 'Muscle soreness, creatine kinase (CK) activity, jump performance, and tensiomyographic variables', 'CK levels']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0010217', 'cui_str': 'Counterpulsation, External'}, {'cui': 'C1640731', 'cui_str': 'Enhanced external counterpulsation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10.0,0.115258,"Exercise resulted in increased muscle soreness (P < 0.001) and CK levels (P < 0.001), as well as in impaired jump performance (P < 0.05).","[{'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Zigor', 'Initials': 'Z', 'LastName': 'Montalvo', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Elaia', 'Initials': 'E', 'LastName': 'Torrontegi', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sánchez-Martínez', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcalá, Madrid, Spain.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000620']
1010,29766292,Gut-derived lipopolysaccharides increase post-prandial oxidative stress via Nox2 activation in patients with impaired fasting glucose tolerance: effect of extra-virgin olive oil.,"PURPOSE


Post-prandial phase is characterized by enhanced oxidative stress but the underlying mechanism is unclear. We investigated if gut-derived lipopolysaccharide (LPS) is implicated in this phenomenon and the effect of extra virgin olive oil (EVOO) in patients with impaired fasting glucose (IFG).
METHODS


This is a randomized cross-over interventional study including 30 IFG patients, to receive a lunch with or without 10 g of EVOO. Serum LPS, Apo-B48, markers of oxidative stress such as oxidized LDL (oxLDL) and soluble Nox2-derived peptide (sNox2-dp), a marker of nicotinamide-adenine-dinucleotide-phosphate oxidase isoform Nox2 activation, and plasma polyphenols were determined before, 60 and 120 min after lunch.
RESULTS


In patients not given EVOO oxidative stress as assessed by sNox2-dp and oxLDL significantly increased at 60 and 120 min concomitantly with an increase of LPS and Apo-B48. In these patients, changes of LPS were correlated with Apo-B48 (Rs = 0.542, p = 0.002) and oxLDL (Rs = 0.463, p = 0.010). At 120 min, LPS (β - 15.73, p < 0.001), Apo-B48 (β - 0.14, p = 0.004), sNox2-dp (β - 5.47, p = 0.030), and oxLDL (β - 42.80, p < 0.001) significantly differed between the two treatment groups. An inverse correlation was detected between polyphenols and oxLDL (R - 0.474, p < 0.005). In vitro study showed that LPS, at the same concentrations found in the human circulation, up-regulated Nox2-derived oxidative stress via interaction with Toll-like receptor 4.
CONCLUSIONS


Post-prandial phase is characterized by an oxidative stress-related inflammation potentially triggered by LPS, a phenomenon mitigated by EVOO administration.",2019,"At 120 min, LPS (β - 15.73, p < 0.001), Apo-B48 (β - 0.14, p = 0.004), sNox2-dp (β - 5.47, p = 0.030), and oxLDL (β - 42.80, p < 0.001) significantly differed between the two treatment groups.","['30 IFG patients', 'patients with impaired fasting glucose (IFG', 'patients with impaired fasting glucose tolerance']","['lunch with or without 10\xa0g of EVOO', 'gut-derived lipopolysaccharide (LPS', 'extra virgin olive oil (EVOO', 'extra-virgin olive oil']","['changes of LPS', 'Serum LPS, Apo-B48, markers of oxidative stress such as oxidized LDL (oxLDL) and soluble Nox2-derived peptide (sNox2-dp', 'sNox2-dp and oxLDL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]","[{'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]",30.0,0.0595437,"At 120 min, LPS (β - 15.73, p < 0.001), Apo-B48 (β - 0.14, p = 0.004), sNox2-dp (β - 5.47, p = 0.030), and oxLDL (β - 42.80, p < 0.001) significantly differed between the two treatment groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Pastori', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Nocella', 'Affiliation': 'Department of AngioCardioNeurology, IRCCS NeuroMed, 86077, Pozzilli, IS, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammisotto', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bartimoccia', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Novo', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Ben', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Farcomeni', 'Affiliation': 'Department of Public Health and Infectious Diseases, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Angelico', 'Affiliation': 'Department of Public Health and Infectious Diseases, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Violi', 'Affiliation': 'I Clinica Medica, Atherothrombosis Center, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. francesco.violi@uniroma1.it.'}]",European journal of nutrition,['10.1007/s00394-018-1718-x']
1011,31862829,Response to Comment on Jakubowicz et al. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care 2019;42:2171-2180.,,2020,,"['Diabetes', 'Patients With Type']",[],['Glycated Hemoglobin and Daily Insulin Dose'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0217909,,"[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel oren.froy@mail.huji.ac.il.'}]",Diabetes care,['10.2337/dci19-0061']
1012,30052699,Self-Incentives Uniquely Boost Cessation in Community-Based Stop Smoking Programs: Randomized Controlled Trial.,"BACKGROUND


Self-incentives offer a plausible alternative to paying smokers to quit but have not yet been tested in a randomized controlled trial.
PURPOSE


The present study tested whether, compared with a control group, prompting smokers explicitly to self-incentivize if they abstain from smoking for a week or a month encouraged sustained abstinence.
METHOD


One hundred and fifty-nine smokers were recruited from stop smoking clinics and randomized to an active control condition (asked to form a plan to quit, n = 65) or one of two intervention conditions in which they were asked to form implementation intentions designed to ensure that they incentivized themselves if they had not smoked at all by the end of (a) the week (n = 44) or (b) the month (n = 50). The main outcome measure was self-reported abstinence at 3- and 6-month follow-ups, which was biochemically verified at baseline and in a subsample at 3-month follow-up.
RESULTS


At 3-month follow-up, 34% (15/44; p < .05, d = 0.45) and 36% (18/50; p < .05, d = 0.49) of smokers abstained in the weekly and monthly self-incentivizing conditions respectively, compared with 15% (10/65) in the control. The same pattern of findings was observed at 6-month follow-up: 30% (13/44; p < .05, d = 0.35), 34% (17/50; p < .05, d = 0.45) and 15% (10/65) of smokers remained abstinent in the two intervention groups and control group, respectively.
CONCLUSIONS


Ensuring that smokers self-incentivized boosted significantly the effectiveness of the stop smoking program. Self-incentivizing implementation intentions could be implemented at low cost with high public health ""reach"" to change many health behaviors beyond smoking.
TRIAL REGISTRATION


ISRCTN11610200.",2019,"At 3-month follow-up, 34% (15/44; p < .05, d = 0.45) and 36% (18/50; p < .05, d = 0.49) of smokers abstained in the weekly and monthly self-incentivizing conditions respectively, compared with 15% (10/65) in the control.","['Community-Based Stop Smoking Programs', 'One hundred and fifty-nine smokers were recruited from stop smoking clinics and randomized to an']",['active control condition'],['self-reported abstinence'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",159.0,0.0571088,"At 3-month follow-up, 34% (15/44; p < .05, d = 0.45) and 36% (18/50; p < .05, d = 0.49) of smokers abstained in the weekly and monthly self-incentivizing conditions respectively, compared with 15% (10/65) in the control.","[{'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Brown', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Centre for Health Psychology, Oxford Road, UK.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Centre for Health Psychology, Oxford Road, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Armitage', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Centre for Health Psychology, Oxford Road, UK.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay056']
1013,29948896,18F-fluorodeoxyglucose use after cardiac transplant: A comparative study of suppression of physiological myocardial uptake.,"BACKGROUND


18F-fluorodeoxyglucose (FDG) has been useful in the evaluation of myocardial inflammatory processes. However, it is challenging to identify them due to physiological 18F-FDG uptake. There are no publications demonstrating the application of FDG in post-transplant rejection in humans yet. The aim of this study is to determine the feasibility of suppression of myocardial FDG uptake in post-transplant patients, comparing three different protocols of preparation.
METHODS


Ten patients after heart transplantation were imaged by FDG associated with three endomyocardial biopsies (EMB), scheduled in the first year after the procedure. Before each imaging, patients were randomized to one of three preparations: (1) hyperlipidic-hypoglycemic diet; (2) fasting longer than 12 hours; and (3) fasting associated with intravenous heparin. All patients would undergo the three methods. FDG images were analyzed using visual analysis scores and relative radiotracer cardiac uptake (RRCU).
RESULTS


The suppression rate of radiotracer activity ranged from 55% to 62%. Visual analysis showed that preparation 3 presented less efficacy in the suppression compared to the others. However, RRCU did not show difference between the preparations.
CONCLUSIONS


Suppression of physiological myocardial FDG uptake after cardiac transplantation is feasible. The usefulness of heparin in the suppression is unclear.",2020,Visual analysis showed that preparation 3 presented less efficacy in the suppression compared to the others.,"['Ten patients after heart transplantation were imaged by FDG associated with three endomyocardial biopsies (EMB), scheduled in the first year after the procedure', '18F-fluorodeoxyglucose use after cardiac transplant', 'post-transplant patients']","['hyperlipidic-hypoglycemic diet; (2) fasting longer than 12\xa0hours; and (3) fasting associated with intravenous heparin', '18F-fluorodeoxyglucose (FDG', 'heparin']","['myocardial FDG uptake', 'suppression rate of radiotracer activity', 'visual analysis scores and relative radiotracer cardiac uptake (RRCU']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy (procedure)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0046056', 'cui_str': 'fludeoxyglucose (18F)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0046056', 'cui_str': 'fludeoxyglucose (18F)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0274053,Visual analysis showed that preparation 3 presented less efficacy in the suppression compared to the others.,"[{'ForeName': 'Renata Christian Martins', 'Initials': 'RCM', 'LastName': 'Felix', 'Affiliation': 'Federal Fluminense University, Av. Marquês do Paraná, 303 - Centro, Niterói, RJ, 24033-900, Brazil. renatafelix@cardiol.br.'}, {'ForeName': 'Clécio Maria', 'Initials': 'CM', 'LastName': 'Gouvea', 'Affiliation': 'National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Christiane Cigagna Wiefels', 'Initials': 'CCW', 'LastName': 'Reis', 'Affiliation': 'National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Jacqueline Sampaio', 'Initials': 'JS', 'LastName': 'Dos Santos Miranda', 'Affiliation': 'National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ligia Beatriz Chaves Espinoso', 'Initials': 'LBCE', 'LastName': 'Schtruk', 'Affiliation': 'National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexandre Siciliano', 'Initials': 'AS', 'LastName': 'Colafranceschi', 'Affiliation': 'National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Tinoco', 'Initials': 'CT', 'LastName': 'Mesquita', 'Affiliation': 'Federal Fluminense University, Av. Marquês do Paraná, 303 - Centro, Niterói, RJ, 24033-900, Brazil.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-018-1309-5']
1014,31264912,Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women.,"Background:  Despite a reduction in the prevalence of vaccine-preventable types of human papillomavirus (HPV), attributed to increased HPV vaccine uptake, HPV continues to be a major cause of cancer in the United States.  Methods:  We assessed factors associated with self-reported HPV vaccine uptake, HPV vaccination effectiveness, using DNA testing to assess HPV types 16 and/or 18 (HPV 16/18) positivity, and patterns of HPV vaccination in 375 women aged 21-29 years who were eligible to receive catch-up vaccination, using baseline data collected from March 2012 to December 2014 from a randomized controlled trial evaluating a novel approach to cervical cancer screening.  Results:  More than half ( n  = 228, 60.8%) of participants reported receipt of at least one HPV vaccine dose and 16 (4.3%) tested positive for HPV 16/18 at baseline. College-educated participants were four times more likely to have been vaccinated than those reporting high school education or less. 56.5% of HPV-vaccinated participants reported first dose after age 18 and 68.4% after first vaginal intercourse. Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  Conclusions:  HPV vaccination is common among college-educated women in the catch-up population but less common among those without college education. Contrary to current guidelines, catch-up females frequently obtain HPV vaccination after age 18 and first vaginal intercourse. Women without a college education represent an ideal population for targeted HPV vaccination efforts that emphasize vaccination before sexual debut.",2019,"Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  ","['college-educated women', 'College-educated participants', 'Young Women', '375 women aged 21-29 years who were eligible to receive catch-up vaccination, using baseline data collected from March 2012 to December 2014']","['novel approach to cervical cancer screening', 'HPV vaccination', 'HPV-16 and HPV-18 DNA Detection']","['HPV vaccine uptake', 'HPV vaccine uptake, HPV vaccination effectiveness']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0999806', 'cui_str': 'Human papillomavirus 16'}, {'cui': 'C0999807', 'cui_str': 'Human papillomavirus 18'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",375.0,0.227387,"Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  ","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Feder', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Shalini L', 'Initials': 'SL', 'LastName': 'Kulasingam', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Kiviat', 'Affiliation': 'Department of Pathology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health, Bloomington, Indiana.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Winer', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Whitham', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Hawes', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7340']
1015,30015637,Effects of Exercise on Sport Concussion Assessment Tool-Third Edition Performance in Women.,"OBJECTIVE


The purpose of this study was to examine the influence of a brief exercise protocol on Sport Concussion Assessment Tool-Third Edition (SCAT3) performance in amateur women athletes.
DESIGN


Cross-over repeated-measures design.
SETTING


Off-season, uninjured community amateur athletes.
PARTICIPANTS


We examined 87 amateur women athlete volunteers (age = 29.9, SD = 6.9 years).
INDEPENDENT VARIABLES


Participants were assessed using the SCAT3 under 2 conditions: at rest and after a 5-minute physical exertion protocol, completed in a counterbalanced order.
MAIN OUTCOME MEASURES


Participants' performance on the various components of the SCAT3 under the 2 conditions: at rest and after a 5-minute physical exertion protocol.
RESULTS


No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3. There were no significant differences in the proportion of participants who endorsed specific symptoms at rest compared with the postexercise condition (P > 0.05). However, women athletes who rated their exertion after exercise as ""hard"" or greater (Borg scale rating 13-20) reported significantly greater blurred vision (M = 0.25, SD = 0.62 vs M = 0.00, SD = 0.00; P = 0.006) and fatigue/low energy (M = 1.38, SD = 1.17 vs M = 0.66, SD = 0.91; P = 0.002) symptoms after exercise than those who rated their exertion as ""light"" or lower (Borg scale rating 6-12).
CONCLUSIONS


In this study of women athletes, a brief bout of exercise did not seem to adversely affect SCAT3 performance and had only small effects on self-reported symptoms. There were differences in symptom reporting, however, in the subgroup of women who rated their exertion levels as ""hard"" or greater; they reported more blurred vision and fatigue/low energy.",2020,"No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3.","['87 amateur women athlete volunteers (age = 29.9, SD = 6.9 years', 'Women', 'women athletes', 'amateur women athletes', 'Off-season, uninjured community amateur athletes']","['Exercise', 'exercise protocol']","['SCAT3 performance', 'Sport Concussion Assessment Tool-Third Edition Performance', 'blurred vision and fatigue/low energy', 'balance, orientation, or cognitive components of the SCAT3', 'endorsed specific symptoms', 'fatigue/low energy', 'Sport Concussion Assessment Tool-Third Edition (SCAT3) performance', 'blurred vision']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",87.0,0.109219,"No significant differences were detected between at-rest and postexercise conditions for the balance, orientation, or cognitive components of the SCAT3.","[{'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Chung Pin Yong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Howell', 'Affiliation': 'The Micheli Center for Sports Injury Prevention, Waltham, Massachusetts.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Meehan', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Grant L', 'Initials': 'GL', 'LastName': 'Iverson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Gardner', 'Affiliation': 'Centre for Stroke and Brain Injury, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000605']
1016,30187910,"Gendered Packaging of a STEM Toy Influences Children's Play, Mechanical Learning, and Mothers' Play Guidance.","To study effects of the gender-packaging of science, technology, engineering, and mathematics (STEM) toys, mother-child dyads (31 daughters; 30 sons; M = 5.2 years) were randomly assigned to play with a mechanical toy packaged for girls (GoldieBlox) or boys (BobbyBlox). When familiarizing themselves with the toy to prepare for play, mothers given BobbyBlox built more with toy pieces than did mothers given GoldieBlox. During dyadic play, mothers with sons built more; mothers with daughters read the toy's narrative instructions more. Children's independent play likewise varied with game packaging. Girls learned the mechanical belt-drive principle better from playing with BobbyBlox; boys learned the principle better from playing with GoldieBlox. Implications for gender-schema theories, STEM interventions, and toy marketing are discussed.",2020,"During dyadic play, mothers with sons built more; mothers with daughters read the toy's narrative instructions more.",['mother-child dyads (31 daughters; 30 sons; M\xa0=\xa05.2\xa0years'],['mechanical toy packaged for girls (GoldieBlox) or boys (BobbyBlox'],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0040565', 'cui_str': 'Toys'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]",[],,0.0217984,"During dyadic play, mothers with sons built more; mothers with daughters read the toy's narrative instructions more.","[{'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Coyle', 'Affiliation': ""Saint Martin's University.""}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Liben', 'Affiliation': 'The Pennsylvania State University.'}]",Child development,['10.1111/cdev.13139']
1017,30265610,"Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).","PURPOSE


Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.
PATIENTS AND METHODS


Patients received escalating doses of oral epacadostat (25, 50, 100, or 300 mg) twice per day plus intravenous pembrolizumab 2 mg/kg or 200 mg every 3 weeks. During the safety expansion, patients received epacadostat (50, 100, or 300 mg) twice per day plus pembrolizumab 200 mg every 3 weeks.
RESULTS


Sixty-two patients were enrolled and received one or more doses of study treatment. The maximum tolerated dose of epacadostat in combination with pembrolizumab was not reached. Fifty-two patients (84%) experienced treatment-related adverse events (TRAEs), with fatigue (36%), rash (36%), arthralgia (24%), pruritus (23%), and nausea (21%) occurring in ≥ 20%. Grade 3/4 TRAEs were reported in 24% of patients. Seven patients (11%) discontinued study treatment because of TRAEs. No TRAEs led to death. Epacadostat 100 mg twice per day plus pembrolizumab 200 mg every 3 weeks was recommended for phase II evaluation. Objective responses (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) occurred in 12 (55%) of 22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck. The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
CONCLUSION


Epacadostat in combination with pembrolizumab generally was well tolerated and had encouraging antitumor activity in multiple advanced solid tumors.",2018,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","['22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck', 'patients with advanced solid tumors', 'Patients received', 'Solid Tumors', 'Patients With Advanced Solid Tumors', 'Sixty-two patients were enrolled and received one or more doses of study treatment']","['Open-Label', 'escalating doses of oral epacadostat', 'Epacadostat 100 mg twice per day plus pembrolizumab', 'Epacadostat Plus Pembrolizumab', 'pembrolizumab']","['pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate', 'pruritus', 'arthralgia', 'Grade 3/4 TRAEs', 'antitumor activity', 'maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics', 'treatment-related adverse events (TRAEs), with fatigue', 'nausea', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1153706', 'cui_str': 'Adenocarcinoma of uterus (disorder)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",62.0,0.0502529,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","[{'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wasser', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Olszanski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Ani S', 'Initials': 'AS', 'LastName': 'Balmanoukian', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Leopold', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.9602']
1018,31647185,"IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life.","BACKGROUND


Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden.
OBJECTIVE


To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300).
DESIGN


Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study.
SETTING


Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States).
PARTICIPANTS


Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration.
METHODS


Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb.
MAIN OUTCOME MEASURES


Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]).
RESULTS


The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P < .0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P < .05 for all caregiving activities except ""applying a splint""). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except ""mobility,"" with significant improvement in EQ-5D visual analog scale scores (P < .001).
CONCLUSIONS


Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden.",2020,Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P<.0001).,"['Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, USA', '296 treated subjects', 'Subjects who completed the 12-week, double-blind main period could enter the', ""Adults, aged 18-80\u2009years, ≥12 months since last botulinum neurotoxin injection or entirely toxin-naïve, with median post-stroke upper-limb spasticity of >2\u2009years' duration""]","['IncobotulinumtoxinA', 'placebo', 'incobotulinumtoxinA', 'open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb']","['EQ-5D visual analog scale scores', 'spasticity-associated functional disability, caregiver burden, and QoL', 'Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol 5-dimensions three-level [EQ-5D-3L', 'Mean DAS score', 'upper-limb functional disability and caregiver burden', 'Carer Burden Scale scores', ""EQ-5D-3L, except 'mobility"", 'Passive Function, Caregiver Burden and Quality of Life', 'QoL']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1295507', 'cui_str': 'Botulinum neurotoxin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",46.0,0.155475,Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P<.0001).,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Marciniak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and Department of Neurology, Northwestern University Feinberg School of Medicine and Shirley Ryan Ability Lab, Chicago, IL.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Munin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC.'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Rubin', 'Affiliation': 'Design Neuroscience Center, Doral, FL.'}, {'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone & Joint Clinic, Overland Park, KS.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Slawek', 'Affiliation': 'Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hiersemenzel', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Elie P', 'Initials': 'EP', 'LastName': 'Elovic', 'Affiliation': 'Department of Medicine, University of Nevada at Reno, Reno, NV.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12265']
1019,31222540,Pre-operative intravenous steroid improves pain and joint mobility after total knee arthroplasty in Chinese population: a double-blind randomized controlled trial.,"INTRODUCTION


This study aims to investigate the effect of pre-operative intravenous methylprednisolone on post-operative pain control and joint mobility in Chinese patients undergoing single primary total knee arthroplasty.
METHODS


This is a prospective, randomized, double-blinded, placebo-controlled single-centre trial. Sixty subjects were randomized into intervention and control group. The peri-operative anaesthetic and analgesic regimes were standardized. The intervention group received 125 mg methylprednisolone intravenously on the induction of anaesthesia. Subjects were assessed at 24, 30 and 48 h after surgery and upon discharge for pain scores and range of movement from the operated knee. Change in C-reactive protein level was calculated. Patient's satisfaction was recorded. Adverse reactions were documented. Subjects were followed up at 6 weeks, 4 months and 1 year.
RESULTS


Rest pain and pain on movement were significantly reduced in the methylprednisolone group at 24 and 30 h after surgery (ANOVA p = 0.030, p = 0.003, p = 0.032, p = 0.010). The methylprednisolone group demonstrated a greater range of movement from the operated knee up to 30 h after surgery (ANOVA p = 0.031). Post-operative C-reactive protein level was significantly less in the methylprednisolone group (p < 0.001). Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01). No adverse effects were noted at the 1-year follow-up.
CONCLUSION


Pre-operative intravenous methylprednisolone improves post-operative pain and joint mobility after total knee arthroplasty up to 30 h after operation. It results in a higher patients' satisfaction. It can act as an effective adjunct in the multimodal analgesic regime.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03082092.",2019,Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01).,"['Sixty subjects', 'total knee arthroplasty in Chinese population', 'Chinese patients undergoing single primary total knee arthroplasty']","['Methylprednisolone', 'Pre-operative intravenous steroid', 'placebo', 'methylprednisolone', 'pre-operative intravenous methylprednisolone']","['Change in C-reactive protein level', 'Rest pain and pain on movement', 'Adverse reactions', 'post-operative pain and joint mobility', ""patient's satisfaction"", 'adverse effects', 'range of movement from the operated knee', 'pain and joint mobility', 'Post-operative C-reactive protein level']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",60.0,0.368583,Methylprednisolone group had a higher patient's satisfaction than the control group (p < 0.01).,"[{'ForeName': 'Bernadette Lok Yiu', 'Initials': 'BLY', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong. cly919@ha.org.hk.'}, {'ForeName': 'Eric Hang Kwong', 'Initials': 'EHK', 'LastName': 'So', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Grace Kit Man', 'Initials': 'GKM', 'LastName': 'Hui', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Boogie Pui Ki', 'Initials': 'BPK', 'LastName': 'Yung', 'Affiliation': 'Physiotherapy Department, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Ada Sau Kwan', 'Initials': 'ASK', 'LastName': 'Tsui', 'Affiliation': 'Physiotherapy Department, Hong Kong Buddhist Hospital, 10 Heng Lam Street, Lok Fu, Kowloon, Hong Kong.'}, {'ForeName': 'Oscar Kam Fung', 'Initials': 'OKF', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Hong Kong Buddhist Hospital, Lok Fu, Hong Kong.'}, {'ForeName': 'Margaret Wai Yee', 'Initials': 'MWY', 'LastName': 'Poon', 'Affiliation': 'Physiotherapy Department, Hong Kong Buddhist Hospital, 10 Heng Lam Street, Lok Fu, Kowloon, Hong Kong.'}, {'ForeName': 'Andy C M', 'Initials': 'ACM', 'LastName': 'Chan', 'Affiliation': 'Physiotherapy Department, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Steven H S', 'Initials': 'SHS', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesiology and Operating Theatre Services, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}, {'ForeName': 'Paul Sin Chuen', 'Initials': 'PSC', 'LastName': 'Yip', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02469-5']
1020,29664672,Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial.,"Rationale:  General practitioners play a passive role in obstructive sleep apnea (OSA) management. Simplification of the diagnosis and use of a semiautomatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages. Objectives:  To determine differences in effectiveness between primary health care area (PHA) and in-laboratory specialized management protocols during 6 months of follow-up. Methods:  A multicenter, noninferiority, randomized, controlled trial with two open parallel arms and a cost-effectiveness analysis was performed in six tertiary hospitals in Spain. Sequentially screened patients with an intermediate to high OSA probability were randomized to PHA or in-laboratory management. The PHA arm involved a portable monitor with automatic scoring and semiautomatic therapeutic decision-making. The in-laboratory arm included polysomnography and specialized therapeutic decision-making. Patients in both arms received continuous positive airway pressure treatment or sleep hygiene and dietary treatment alone. The primary outcome measure was the Epworth Sleepiness Scale. Secondary outcomes were health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, continuous positive airway pressure adherence, and within-trial costs. Measurements and Main Results:  In total, 307 patients were randomized and 303 were included in the intention-to-treat analysis. Based on the Epworth Sleepiness Scale, the PHA protocol was noninferior to the in-laboratory protocol. Secondary outcome variables were similar between the protocols. The cost-effectiveness relationship favored the PHA arm, with a cost difference of €537.8 per patient. Conclusions:  PHA management may be an alternative to in-laboratory management for patients with an intermediate to high OSA probability. Given the clear economic advantage of outpatient management, this finding could change established clinical practice.Clinical trial registered with www.clinicaltrials.gov (NCT02141165).",2018,"Simplification of the diagnosis and use of a semi-automatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages.
","['Sequentially screened patients with suspected OSA', 'Sleep Apnea Patients', 'General practitioners play a passive role in obstructive sleep apnea (OSA) management', '307 patients were randomized and 303 were included in the intention-to-treat analysis', 'six tertiary hospitals in Spain']","['polysomnography (PSG', 'portable monitor (PM) with automatic scoring and semi-automatic therapeutic decision-making', 'continuous positive airway pressure (CPAP) treatment or only sleep hygiene and dietary treatment']","['Epworth sleepiness scale (ESS', 'cost-effectiveness relationship', 'health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, CPAP adherence and within-trial costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",307.0,0.150682,"Simplification of the diagnosis and use of a semi-automatic algorithm for treatment can facilitate the integration of general practitioners, which has cost advantages.
","[{'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'Virgen del Puerto Hospital, Plasencia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Gómez-de-Terreros', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Carmona-Bernal', 'Affiliation': 'Virgen del Rocío Hospital, Seville, Spain.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Asensio-Cruz', 'Affiliation': 'Virgen del Rocío Hospital, Seville, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cabello', 'Affiliation': 'Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Martínez-Martínez', 'Affiliation': 'Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Egea', 'Affiliation': 'Organización Sanitaria Integrada, Bioaraba Research Institute, Araba University Hospital, Vitoria, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax', 'Affiliation': 'Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbe', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Extremadura University, Cáceres, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201710-2061OC']
1021,30477346,"Comments on ""Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial"".",,2019,,['De Quervain Tenosynovitis'],[],[],"[{'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}]",[],[],,0.0176729,,"[{'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Abi-Rafeh', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Kazan', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thibaudeau', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada.'}]","Hand (New York, N.Y.)",['10.1177/1558944718813734']
1022,29626232,A pre-meal of whey proteins induces differential effects on glucose and lipid metabolism in subjects with the metabolic syndrome: a randomised cross-over trial.,"PURPOSE


Postprandial lipaemia (PPL), an independent risk factor for cardiovascular disease, is affected by composition and timing of meals. We evaluated if whey proteins (WP) consumed as a pre-meal before a fat-rich meal reduce postprandial triglyceride (TG) and apolipoprotein B-48 (ApoB-48) responses in subjects with the metabolic syndrome (MeS).
METHODS


An acute, randomised, cross-over trial was conducted. 20 subjects with MeS consumed a pre-meal of 0, 10 or 20 g WP 15 min prior to a fat-rich meal. The responses of TG and ApoB-48 were assessed. We also analysed postprandial responses of free fatty acids (FFA), glucose, insulin, glucagon, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP) and paracetamol (reflecting gastric emptying rates).
RESULTS


WP pre-meal did not alter the TG or ApoB-48 responses. In contrast, the insulin response was more pronounced after a pre-meal of 20 g WP than with 10 g WP (P = 0.0005) and placebo (P < 0.0001). Likewise, the postprandial glucagon response was greater with a pre-meal of 20 g WP than with 10 g WP (P < 0.0001) and 0 g WP (P < 0.0001). A pre-meal with 20 g of WP generated lower glucose (P = 0.0148) and S-paracetamol responses (P = 0.0003) and a higher GLP-1 response (P = 0.0086) than placebo. However, the pre-meal did not influence responses of GIP, FFA or appetite assessed by a Visual Analog Scale.
CONCLUSIONS


Consumption of a WP pre-meal prior to a fat-rich meal did not affect TG and chylomicron responses. In contrast, the WP pre-meal stimulates insulin and glucagon secretion and reduces blood glucose as expected, and delays gastric emptying. Consequently, our study points to a differential impact of a WP pre-meal on lipid and glucose metabolism to a fat-rich meal in subjects with MeS.",2019,"However, the pre-meal did not influence responses of GIP, FFA or appetite assessed by a Visual Analog Scale.
","['subjects with the metabolic syndrome (MeS', 'subjects with MeS', 'subjects with the metabolic syndrome', '20 subjects with MeS consumed a pre-meal of 0, 10 or 20']","['whey proteins (WP', 'placebo']","['postprandial responses of free fatty acids (FFA), glucose, insulin, glucagon, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP) and paracetamol (reflecting gastric emptying rates', 'higher GLP-1 response', 'S-paracetamol responses', 'TG or ApoB-48 responses', 'WP pre-meal stimulates insulin and glucagon secretion and reduces blood glucose', 'postprandial triglyceride (TG) and apolipoprotein B-48 (ApoB-48) responses', 'GIP, FFA or appetite assessed by a Visual Analog Scale', 'insulin response', 'delays gastric emptying', 'glucose and lipid metabolism', 'postprandial glucagon response']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0103839', 'cui_str': 'Chylomicron Apo B'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",20.0,0.0497458,"However, the pre-meal did not influence responses of GIP, FFA or appetite assessed by a Visual Analog Scale.
","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bjørnshave', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Tage-Hansens Gade 2, 8000, Aarhus C, Denmark. ann.bjoernshave@clin.au.dk.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'NNF Centre for Basic Metabolic Research and The Department of Biomedical Sciences, University of Copenhagen, Blegdamsvej 3, 2200, København N, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Tage-Hansens Gade 2, 8000, Aarhus C, Denmark.'}]",European journal of nutrition,['10.1007/s00394-018-1684-3']
1023,29698340,Teaching Point-of-Care Lung Ultrasound to Novice Pediatric Learners: Web-Based E-Learning Versus Traditional Classroom Didactic.,"OBJECTIVE


To assess whether Web-based teaching is at least as effective as traditional classroom didactic in improving the proficiency of pediatric novice learners in the image acquisition and interpretation of pneumothorax and pleural effusion using point-of-care ultrasound (POCUS).
METHODS


We conducted a randomized controlled noninferiority study comparing the effectiveness of Web-based teaching to traditional classroom didactic. The participants were randomized to either group A (live classroom lecture) or group B (Web-based lecture) and completed a survey and knowledge test. They also received hands-on training and completed an objective structured clinical examination. The participants were invited to return 2 months later to test for retention of knowledge and skills.
RESULTS


There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1). Similarly, no significant differences were noted in the mean objective structured clinical examination scores for both intervention groups in postcourse (absolute difference, 1.9; 95% CI, -4.7 to 8.5) and 2-month retention (absolute difference, -0.6; 95% CI, -10.7 to 9.5).
CONCLUSIONS


Web-based teaching is at least as effective as traditional classroom didactic in improving the proficiency of novice learners in POCUS. The usage of Web-based tutorials allows a more efficient use of time and a wider dissemination of knowledge.",2020,"There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1).",['Novice Pediatric Learners'],"['Web-based teaching to traditional classroom didactic', ' Web-Based E-Learning', 'group A (live classroom lecture']","['mean objective structured clinical examination scores', 'mean written test scores', '2-month retention']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.102566,"There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1).","[{'ForeName': 'Aun Woon', 'Initials': 'AW', 'LastName': 'Soon', 'Affiliation': ""From the Women's and Children's Hospital, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Amanda Greene', 'Initials': 'AG', 'LastName': 'Toney', 'Affiliation': 'Denver Health Medical Center.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Stidham', 'Affiliation': ""Children's Hospital Colorado.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Denver Health Medical Center University of Colorado.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Roosevelt', 'Affiliation': 'Denver Health Medical Center, Denver, CO.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001482']
1024,29331848,"Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.","Apathy is a common and disabling behavioral concomitant of many neurodegenerative conditions. The presence of apathy with Mild Cognitive Impairment (MCI) is linked with heightened rates of conversion to Alzheimer's disease. Improving apathy may slow the neurodegenerative process. The objective was to establish the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving apathy in older adults with MCI. An 8-week, double-blind, randomized, sham-controlled cross-over study was conducted in nine subjects (66 ± 9 years) with apathy and MCI. Subjects were randomized to rTMS or sham treatment (5 days/week) for 2 weeks following which they underwent a 4-week treatment-free period. Subjects then crossed-over to receive the other treatment for 2 weeks. The primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes were assessed at baseline, 2, 6, and 8 weeks. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment at 2 weeks. There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI-I with rTMS compared to the sham treatment. This study establishes that rTMS is efficacious in improving apathy in subjects with MCI.",2018,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","['older adults with MCI', 'subjects with MCI', 'mild cognitive impairment', 'nine subjects (66 ± 9 years) with apathy and MCI']","['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS, MMSE, TMT-A, and CGI', 'primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.25973,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA. Electronic address: Prasad.Padala@va.gov.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Jackson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Bopp', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Mennemeier', 'Affiliation': 'Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Roberson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Sullivan', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]",Psychiatry research,['10.1016/j.psychres.2017.12.063']
1025,29494211,Disease Management plus Recommended Care versus Recommended Care Alone for Ambulatory Patients with Chronic Obstructive Pulmonary Disease.,"Rationale:  The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. Objectives:  To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD. Measurements and Main Results:  In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care  vis-à-vis  other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08). Conclusions:  DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.",2018,"CONCLUSIONS


DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory COPD patients.","['ambulatory COPD patients', 'Ambulatory COPD Patients', '1,202 COPD patients (age >40 years), with moderate to very severe airflow limitation', ""patients' visits to the designated COPD centers and remote contacts with the patients between these visits, included patient self-care education; monitoring patients' symptoms and adherence to treatment; provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers"", 'patients with chronic obstructive pulmonary disease (COPD']","['disease management (DM) added to recommended care (RC', 'Care versus Recommended Care Alone', 'DM plus RC (study intervention) or to RC alone (control intervention', 'disease management programs']","['hospital admission for respiratory symptoms or death from any cause', 'median (range) time elapsed until a primary endpoint event']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001314', 'cui_str': 'Acute Disease'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}]","[{'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1202.0,0.078133,"CONCLUSIONS


DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory COPD patients.","[{'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Kalter-Leibovici', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Benderly', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Kaufman', 'Affiliation': 'Northern District, Maccabi Health Care Services, Haifa, Israel.'}, {'ForeName': 'Tchiya', 'Initials': 'T', 'LastName': 'Molcho Falkenberg Luft', 'Affiliation': 'Community Division, Clalit Health Services, Tel-Aviv, Israel.'}, {'ForeName': 'Havi', 'Initials': 'H', 'LastName': 'Murad', 'Affiliation': 'Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Liraz', 'Initials': 'L', 'LastName': 'Olmer', 'Affiliation': 'Biostatistics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Meri', 'Initials': 'M', 'LastName': 'Gluch', 'Affiliation': 'Tel-Aviv District, Clalit Health Services, Tel-Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Segev', 'Affiliation': 'Sharon-Shomron District, Clalit Health Services, Hadera, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilad', 'Affiliation': 'Central District, Clalit Health Services, Tel-Aviv, Israel.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Elkrinawi', 'Affiliation': 'Pulmonary Institute, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonology, Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Jacobson', 'Affiliation': 'MOR Institute for Medical Data, Bnei Brak, Israel.'}, {'ForeName': 'Calanit', 'Initials': 'C', 'LastName': 'Key', 'Affiliation': 'Community Division, Clalit Health Services, Tel-Aviv, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Shani', 'Affiliation': 'Medical Research Infrastructure Development and Health Services Fund, Chaim Sheba Medical Center, Tel-Hashomer, Israel; and.'}, {'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Fink', 'Affiliation': 'Clinical Research Institute, Kaplan Medical Center, Rechovot, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201711-2182OC']
1026,31629944,Cluster Randomized Trial of a Pre/Interconception Health Intervention for Mothers in Pediatric Visits.,"OBJECTIVE


Recognizing that pediatric primary care focuses on family health and is an important location of contact for women of childbearing age, this project assessed the effectiveness of a pre/interconception women's health intervention delivered during pediatric primary care using a cluster randomized trial.
METHODS


Pediatric clinicians were randomized to a screening and brief educational intervention group or usual care comparison group. Intervention group clinicians received training on pre/interconception care, including recommended counseling and referral resources for needs identified. Women presenting to primary care with their child ≤12 months were enrolled and assigned to the group corresponding to the assignment of their child's clinician. Mothers seen by clinicians in the intervention group completed a pre/interconception health screening tool and discussed results with their child's clinician during the visit. These mothers were compared to mothers seen by comparison group clinicians who did not receive the screening tool or clinician discussion. All enrolled mothers (Intervention and Comparison) received written preconception health information and a 90-day supply of multivitamins. Primary outcomes at 6 and 12 months post enrollment included contraception use, pregnancy, and access to and use of preventive health care. Secondary outcomes included daily folic acid supplementation, smoking, and substance use.
RESULTS


A total of 415 women were enrolled and those who had at least 1 follow-up assessment were included in the analysis (n = 383). There was no significant effect of the intervention on contraceptive use, pregnancy incidence, or use of preventive care. Assignment to the intervention increased the odds of daily folic acid use (odds ratio 1.82, 95% confidence interval 1.25, 2.63) during follow-up. Intervention mothers were less likely to smoke at 6, but not 12 months.
CONCLUSIONS


Pediatric visits are an opportune location for addressing maternal health and this intervention demonstrated feasibility and improved outcomes for some but not all outcomes. Attention to maternal health needs in pediatric visits during infancy may be important for maintaining positive pre/interconception health behaviors.",2020,"Assignment to the intervention increased the odds of daily folic acid use [OR 1.82, 95% CI 1.25, 2.63] during follow-up.","['Mothers In Pediatric Visits', 'women of childbearing age', 'Pediatric clinicians', '415 women were enrolled and those who had at least one follow-up assessment were included in the analysis (n= 383', 'Women presenting to primary care with their child ≤12 months']","['written preconception health information and a 90 day supply of multivitamins', 'screening and brief educational intervention group or usual care comparison group', 'training on pre/interconception care, including recommended counseling and referral resources for needs identified', 'Pre/Interconception Health Intervention']","['daily folic acid supplementation, smoking and substance use', 'contraception use, pregnancy, and access to and use of preventive health care', 'contraceptive use, pregnancy incidence, or use of preventive care', 'odds of daily folic acid use']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0033109', 'cui_str': 'Preventive Health'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4277527', 'cui_str': 'Preventive Care'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]",415.0,0.0515678,"Assignment to the intervention increased the odds of daily folic acid use [OR 1.82, 95% CI 1.25, 2.63] during follow-up.","[{'ForeName': 'Krishna K', 'Initials': 'KK', 'LastName': 'Upadhya', 'Affiliation': ""Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Division of Adolescent and Young Adult Medicine, Children's National Medical Center, (KK Upadhya), Washington, DC.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Psoter', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Connor', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md.'}, {'ForeName': 'Kamila B', 'Initials': 'KB', 'LastName': 'Mistry', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Office of Extramural Research, Education and Priority Populations, Agency for Healthcare Research and Quality, (KB Mistry), Rockville, Md.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Levy', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Child and Teen Wellness Center, (DJ Levy), Owings Mills, Md.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, (KK Upadhya, KJ Psoter, KA Connor, KB Mistry, DJ Levy, and TL Cheng), Baltimore, Md; Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, (TL Cheng), Baltimore, Md. Electronic address: tcheng2@jhmi.edu.'}]",Academic pediatrics,['10.1016/j.acap.2019.10.003']
1027,31633607,Population Pharmacokinetics of Levobupivacaine During Transversus Abdominis Plane Block in Children.,"BACKGROUND


Levobupivacaine is commonly used during transversus abdominis plane (TAP) block in pediatric patients. However, the dosing regimen is still empirical, and the pharmacokinetic properties of levobupivacaine are not considered. Here, the pharmacokinetics of levobupivacaine during an ultrasound-guided TAP block were evaluated to optimize dosing regimen, regarding the between-subject variability (BSV) and the volume of levobupivacaine injected.
METHOD


The clinical trial (prospective, randomized, double-blind study protocol) was conducted in 40 children aged 1-5 years, who were scheduled for inguinal surgery. Each patient received 0.4 mg/kg of levobupivacaine with a volume of local anesthesia solution adjusted to 0.2 mL/kg of 0.2% or 0.4 mL/kg of 0.1% levobupivacaine. Blood samples were collected at 5, 15, 20, 25, 30, 45, 60, and 75 minutes after the block injection. The population pharmacokinetic analysis was performed using the NONMEM software.
RESULTS


From the pharmacokinetic parameters obtained, median Cmax, tmax,, and area under the concentration versus time curve were 0.315 mg/L, 17 minutes, and 41 mg/L·min, respectively. BSV of clearance was explained by weight. At the dose regimen of 0.4 mg/kg, none of the infants showed signs of toxicity, but in 13 patients, TAP block failed. After analysis, BSV for absorption rate constant, distribution volume, and clearance were 81%, 47%, and 41%, respectively. Residual unexplained variability was estimated to be 14%.
CONCLUSIONS


For improved efficiency in the pediatric population, the dose of levobupivacaine should be greater than 0.4 mg/kg. Children's weight should be considered to anticipate any risk of toxicity.",2020,"median Cmax, tmax, and area under the concentration versus time curve were 0.315 mg/L, 17 min, and 41 mg/L. min, respectively.","['40 children aged 1 to 5 years, who were scheduled for inguinal surgery', 'pediatric patients', 'Children']","['levobupivacaine', 'Levobupivacaine']","['Blood samples', 'BSV for absorption rate constant, distribution volume, and clearance', 'signs of toxicity', 'Residual unexplained variability', 'median Cmax, tmax, and area under the concentration versus time curve']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",40.0,0.147215,"median Cmax, tmax, and area under the concentration versus time curve were 0.315 mg/L, 17 min, and 41 mg/L. min, respectively.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': 'Department of Pharmacokinetics, School of Pharmacy, Montpellier University.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mathieu', 'Affiliation': 'Department of Toxicology and Target Drug Monitoring, Montpellier University Hospital (CHU Lapeyronie).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nolain', 'Affiliation': 'Department of Pharmacometrics, Sanofi.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Menacé', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Montpellier University Hospital (CHU Lapeyronie).'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Khier', 'Affiliation': 'Department of Pharmacokinetics, School of Pharmacy, Montpellier University.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000702']
1028,31585725,"Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.","BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6-23-month old Filipino children.
METHODS


This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6-23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination.
RESULTS


A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9-12 months, and 13-23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p < 0.0001]. A similar pattern of immunogenicity was reported across all age strata. The vaccine reported to be safe and well tolerated.
CONCLUSIONS


Vi-DT vaccine was immunogenic, safe, and well tolerated in children aged 6-23 months. ClinicalTrials.gov registration number: NCT03527355.",2020,"BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","['Muntinlupa City, The Philippines', 'healthy Filipino infants and toddlers', 'school-aged children', 'Participants aged 6-23\u202fmonths', '6-23-month old Filipino children', '285 participants were enrolled and age-stratified: 6 to < 9\u202fmonths, 9-12\u202fmonths, and 13-23\u202fmonths', 'Seventy-six (76) participants received', 'children aged 6-23\u202fmonths']","['Vi-DT vaccine', 'Vi-DT', 'placebo (0.9% sodium chloride', 'placebo', 'Vi-DT typhoid conjugate vaccine', 'Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT']","['safety, reactogenicity, and immunogenicity data', 'GMT', 'Immunogenicity, safety and reactogenicity', 'safe and well tolerated', 'immunogenicity, safety and reactogenicity']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1556093', 'cui_str': 'Filipinos (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0058773', 'cui_str': 'DT Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",285.0,0.64885,"BACKGROUND


Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea. Electronic address: tarun.saluja@ivi.int.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Ham', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",Vaccine,['10.1016/j.vaccine.2019.09.074']
1029,31626692,"Predictors and Clinical Outcomes of Poor Platelet Recovery in Adult Dengue With Thrombocytopenia: A Multicenter, Prospective Study.","BACKGROUND


Platelet transfusion is common in dengue patients with thrombocytopenia. We previously showed in a randomized clinical trial that prophylactic platelet transfusion did not reduce clinical bleeding. In this study, we aimed to characterize the predictors and clinical outcomes of poor platelet recovery in transfused and nontransfused participants.
METHODS


We analyzed patients from the Adult Dengue Platelet Study with laboratory-confirmed dengue with ≤20 000 platelets/μL and without persistent mild bleeding or any severe bleeding in a post hoc analysis. Poor platelet recovery was defined as a platelet count of ≤20 000/μL on Day 2. We recruited 372 participants from 5 acute care hospitals located in Singapore and Malaysia between 29 April 2010 and 9 December 2014. Of these, 188 were randomly assigned to the transfusion group and 184 to the control group.
RESULTS


Of 360 patients, 158 had poor platelet recovery. Age, white cell count, and day of illness at study enrollment were significant predictors of poor platelet recovery after adjustment for baseline characteristics and platelet transfusion. Patients with poor platelet recovery had longer hospitalizations but no significant difference in other clinical outcomes, regardless of transfusion. We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
CONCLUSIONS


Dengue patients with thrombocytopenia who were older or presented earlier and with lower white cell counts were more likely to have poor platelet recovery. In patients with poor platelet recovery, platelet transfusion does not improve outcomes and may actually increase the risk of bleeding. The mechanisms of poor platelet recovery need to be determined.
CLINICAL TRIALS REGISTRATION


NCT01030211.",2020,"We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
","['372 participants from 5 acute care hospitals located in Singapore and Malaysia between 29 April 2010 and 9 December 2014', 'dengue patients with thrombocytopenia', 'patients from the Adult Dengue Platelet Study with laboratory-confirmed dengue with ≤20 000 platelets/μL and without persistent mild bleeding or any severe bleeding in a post hoc analysis', 'transfused and nontransfused participants', 'Of 360 patients, 158 had poor platelet recovery', 'Adult Dengue With Thrombocytopenia']",[],"['risk of bleeding', 'Poor platelet recovery', 'clinical bleeding']","[{'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",372.0,0.0749228,"We found a significant interaction between platelet recovery and transfusion; patients with poor platelet recovery were more likely to bleed if given a prophylactic platelet transfusion (odds ratio 2.34, 95% confidence interval 1.18-4.63).
","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Po Ying', 'Initials': 'PY', 'LastName': 'Chia', 'Affiliation': 'Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Sharifah F', 'Initials': 'SF', 'LastName': 'Syed-Omar', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Sasheela S L', 'Initials': 'SSL', 'LastName': 'Ponnampalavanar', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Adeeba', 'Initials': 'A', 'LastName': 'Kamarulzaman', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lucy C S', 'Initials': 'LCS', 'LastName': 'Lum', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Yee-Sin', 'Initials': 'YS', 'LastName': 'Leo', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz850']
1030,31635890,Riluzole Oral Suspension: Bioavailability Following Percutaneous Gastrostomy Tube-modeled Administration Versus Direct Oral Administration.,"PURPOSE


During amyotrophic lateral sclerosis progression, up to 85% of patients develop dysphagia. Riluzole oral suspension 50 mg/10 mL is bioequivalent to riluzole 50-mg film-coated tablets administered orally under fasting conditions. Here, we compare the bioavailability of a single 50-mg dose of riluzole oral suspension via intragastric tube, a proxy for percutaneous endoscopic gastrostomy administration, with that of oral administration in healthy volunteers under fasting conditions. Secondary objectives included the plasma pharmacokinetic and safety profiles of each administration route.
METHODS


This was a single-center, single-dose, open-label, randomized, 2-period, 2-sequence, crossover bioequivalence/bioavailability study. Healthy volunteers were randomized to riluzole oral suspension 50 mg/10 mL either via nasogastric tube or orally, with a 5-day washout before crossover.
FINDINGS


A total of 32 subjects were randomized (safety population); 30 were eligible for pharmacokinetic analysis. The ratios (nasogastric tube/oral) of the geometric least squares means and the geometric 90% CIs of AUC 0-t , AUC 0-inf , and C max  were calculated to be 90.60% (85.66%-95.82%), 90.43% (85.47%-95.67%), and 96.99% (89.40%-105.23%), respectively, indicating bioequivalence. No significant differences in C max , T max , K el , and t 1/2el  between treatments were found. Overall, riluzole oral suspension was well tolerated. No deaths or other serious adverse events were reported.
IMPLICATIONS


In this study, riluzole oral suspension was bioequivalent when administered intragastrically and orally in healthy subjects under fasting conditions. Both administration methods were well tolerated. These results show that intragastric administration of riluzole oral suspension may provide an important formulation option in people with amyotrophic lateral sclerosis who have a percutaneous endoscopic gastrostomy tube.",2019,"No significant differences in C max , T max , K el , and t 1/2el  between treatments were found.","['people with amyotrophic lateral sclerosis who have a percutaneous endoscopic gastrostomy tube', 'Healthy volunteers', 'healthy volunteers under fasting conditions', '50 mg/10', '32 subjects were randomized (safety population); 30 were eligible for pharmacokinetic analysis', 'healthy subjects under fasting conditions']","['Riluzole', 'riluzole oral suspension', 'riluzole oral suspension 50 mg/10\xa0mL either via nasogastric tube', '2019;41:XXX-XXX', 'Riluzole oral suspension']","['tolerated', 'C max , T max , K el , and t 1/2el', 'plasma pharmacokinetic and safety profiles of each administration route', 'ratios (nasogastric tube/oral) of the geometric least squares means and the geometric 90% CIs of AUC 0-t , AUC 0-inf , and C max', 'No deaths or other serious adverse events']","[{'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C0442474', 'cui_str': 'Via nasogastric tube (qualifier value)'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",32.0,0.0501427,"No significant differences in C max , T max , K el , and t 1/2el  between treatments were found.","[{'ForeName': 'Benjamin Rix', 'Initials': 'BR', 'LastName': 'Brooks', 'Affiliation': 'Atrium Health Neurosciences Institute, Carolinas Medical Center, University of North Carolina School of Medicine-Charlotte Campus, Charlotte, NC, United States. Electronic address: benjamin.brooks@atriumhealth.org.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bettica', 'Affiliation': 'Italfarmaco SpA, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cazzaniga', 'Affiliation': 'Italfarmaco SpA, Milan, Italy.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.016']
1031,31629118,Feasibility and Effectiveness of Telelactation Among Rural Breastfeeding Women.,"OBJECTIVE


To evaluate the feasibility and impact of telelactation via personal electronic devices on breastfeeding duration and exclusivity among rural women.
METHODS


The Tele-MILC trial, a pragmatic, parallel design trial, recruited 203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n = 102) or usual care (n = 101). We used intent-to-treat (ITT) and instrumental variable (IV) approaches to analyze study data for the 187 participants who completed follow-up. The primary outcomes were any breastfeeding and exclusive breastfeeding at 12 weeks postpartum.
RESULTS


Among participants in the telelactation arm, 50% (47/94) reported participating in video calls. At 12 weeks, 71% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the ITT model (3% difference, P = .73), whereas 73% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the IV model (5% difference, P = .74). Among participants who were still breastfeeding at 12 weeks, 51% participants in the telelactation arm were breastfeeding exclusively versus 46% of control participants in the ITT model (5% difference, P = .47), whereas 56% of participants in the telelactation arm were breastfeeding exclusively versus 45% of control participants in the IV model (11% difference, P = .48). In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
CONCLUSIONS


This trial demonstrated that telelactation can be implemented with a rural underserved population. Though this trial was not powered to detect differences in breastfeeding duration and exclusivity, and none were observed, telelactation remains a promising approach for further investigation. ClinicalTrials.gov Identifier: NCT02870413.",2020,"In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
","['rural underserved population', '203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n=102) or usual care (n=101', 'participants in the telelactation arm, 50% (47/94) reported participating in video calls', 'rural women', 'Rural Breastfeeding Women', '187 participants who completed follow-up']","['Telelactation', 'telelactation via personal electronic devices']","['breastfeeding and exclusive breastfeeding at 12 weeks postpartum', 'breastfeeding duration and exclusivity', 'breastfeeding in the ITT model']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",203.0,0.165296,"In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant.
","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Uscher-Pines', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va. Electronic address: luscherp@rand.org.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ghosh-Dastidar', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine (DL Bogen and KN Ray), Pittsburgh, Pa.'}, {'ForeName': 'Kristin N', 'Initials': 'KN', 'LastName': 'Ray', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine (DL Bogen and KN Ray), Pittsburgh, Pa.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'University of Pittsburgh School of Nursing (JR Demirci), Pittsburgh, Pa.'}, {'ForeName': 'Ateev', 'Initials': 'A', 'LastName': 'Mehrotra', 'Affiliation': 'Harvard Medical School (A Mehrotra), Boston, Mass.'}, {'ForeName': 'Kandice A', 'Initials': 'KA', 'LastName': 'Kapinos', 'Affiliation': 'RAND Corporation (L Uscher-Pines, B Ghosh-Dastidar, and KA Kapinos), Arlington, Va.'}]",Academic pediatrics,['10.1016/j.acap.2019.10.008']
1032,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE


To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
RESEARCH DESIGN AND METHODS


Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study.
RESULTS


A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P  = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI.
CONCLUSIONS


Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993']
1033,29509867,Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial.,"Importance


Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.
Objective


To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.
Design, Setting, and Participants


Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.
Interventions


Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.
Main Outcomes and Measures


The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).
Results


Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, -0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).
Conclusions and Relevance


Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.
Trial Registration


clinicaltrials.gov Identifier: NCT01583985.",2018,"Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).
","['265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized', 'Osteoarthritis Pain', '240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial', 'Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use', 'Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016', 'Patients With Chronic Back Pain or Hip or Knee']","['Opioid vs Nonopioid Medications', 'nonopioid medications', 'acetaminophen (paracetamol', 'opioid therapy', 'interventions (opioid and nonopioid medication therapy', 'morphine, oxycodone, or hydrocodone/acetaminophen', 'opioid vs nonopioid medications']","['pain-related function', 'Pain intensity', 'mean 12-month BPI severity', 'pain-related function, pain intensity, and adverse effects', 'Pain-Related Function', 'pain-related function (Brief Pain Inventory [BPI] interference scale', 'Adverse medication-related symptoms', 'pain intensity (BPI severity scale', 'mean 12-month BPI interference', 'pain and function', 'BPI scales', 'medication-related symptoms (patient-reported checklist; range, 0-19']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0303721', 'cui_str': 'Americium-240 (substance)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",240.0,0.210444,"Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).
","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gravely', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Nugent', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Agnes C', 'Initials': 'AC', 'LastName': 'Jensen', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'DeRonne', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Goldsmith', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.'}]",JAMA,['10.1001/jama.2018.0899']
1034,29470691,Even effect of milk protein and carbohydrate intake but no further effect of heavy resistance exercise on myofibrillar protein synthesis in older men.,"PURPOSE


The responsiveness of older individuals' skeletal muscle to anabolic strategies may be impaired. However, direct comparisons within the same experimental setting are sparse. The aim of this study was to assess the resting and post-resistance exercise muscle protein synthesis rates in response to two types of milk protein and carbohydrate using a unilateral exercise leg model.
METHODS


Twenty-seven older (69 ± 1 year, mean ± SE) men were randomly assigned one of three groups: Whey hydrolysate (WH), caseinate (CAS), or carbohydrate (CHO). By applying stable isotope tracer techniques (L-[ 15 N]phenylalanine), the fasted-rested (basal) myofibrillar fractional synthesis rate (FSR) was measured. Hereafter, FSR was measured in the postprandial phase (0.45 g nutrient/kg LBM) in both legs, one rested (fed-rest) and one exercised (10 × 8 reps at 70% 1RM; fed-exercise). In addition, the activity of p70S6K and venous plasma insulin, phenylalanine, and leucine concentrations were measured.
RESULTS


Insulin, phenylalanine, and leucine concentrations differed markedly after intake of the different study drinks. The basal FSR in WH, CAS, and CHO were 0.027 ± 0.003, 0.030 ± 0.003, and 0.030 ± 0.004%/h, the fed-rested FSR were 0.043 ± 0.004, 0.045 ± 0.003, and 0.035 ± 0.004%/h, and the fed-exercised FSR were 0.041 ± 0.004, 0.043 ± 0.004, and 0.034 ± 0.004%/h, respectively. No significant differences were observed at any state between the groups. Fed-rested- and fed-exercised FSR were higher than basal (P < 0.001). 3 h after exercise and feeding, no significant group differences were detected in the activity of p70S6K.
CONCLUSIONS


Milk protein and carbohydrate supplementation stimulate myofibrillar protein synthesis in older men, with no further effect of heavy resistance exercise within 0-3 h post exercise.",2019,Fed-rested- and fed-exercised FSR were higher than basal (P < 0.001).,"['Twenty-seven older (69\u2009±\u20091\xa0year, mean\u2009±\u2009SE', 'older men']","['carbohydrate supplementation', 'heavy resistance exercise', 'stable isotope tracer techniques (L-[ 15 N]phenylalanine', 'milk protein and carbohydrate intake', 'Whey hydrolysate (WH), caseinate (CAS), or carbohydrate (CHO']","['myofibrillar protein synthesis', 'activity of p70S6K and venous plasma insulin, phenylalanine, and leucine concentrations', 'Insulin, phenylalanine, and leucine concentrations', 'heavy resistance exercise', 'basal FSR in WH, CAS, and CHO', 'fasted-rested (basal) myofibrillar fractional synthesis rate (FSR']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C3535837', 'cui_str': 'caseinate'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1136240', 'cui_str': 'Ribosomal Protein S6 Kinases, 70-kDa'}, {'cui': 'C3838734', 'cui_str': 'Venous plasma'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0226173,Fed-rested- and fed-exercised FSR were higher than basal (P < 0.001).,"[{'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Reitelseder', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark. soeren.reitelseder@regionh.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Agergaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Nikolaj M', 'Initials': 'NM', 'LastName': 'Malmgaard-Clausen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Rasmus L', 'Initials': 'RL', 'LastName': 'Bechshoeft', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Rasmus K', 'Initials': 'RK', 'LastName': 'Petersen', 'Affiliation': 'Department of Biology, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Serena', 'Affiliation': 'Arla Foods amba, Viby J, Denmark.'}, {'ForeName': 'Ulla R', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Arla Foods Ingredients Group P/S, Viby J, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holm', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Bispebjerg Bakke 23, building 8, 1st floor, 2400, Copenhagen NV, Denmark.'}]",European journal of nutrition,['10.1007/s00394-018-1641-1']
1035,31628894,Spino-cerebellar tDCS modulates N100 components of the P300 event related potential.,"OBJECTIVE


To evaluate the role of the cerebellum and spinal cord in cognitive processes, we assessed changes in event-related potentials (ERPs), before and after different combinations of spinal and cerebellar direct current stimulation (tDCS) in healthy subjects.
METHOD


We enrolled 37 volunteers (11 males and 26 females, aged 20-50 years), who were subsequently randomly assigned to one of four stimulation conditions: i) anodal cerebellar tDCS, with the reference electrode over the right shoulder; ii) anodal spinal tDCS, with the reference electrode over the right shoulder; iii) anodal spinal tDCS with cathodal cerebellar tDCS, and iv) sham stimulation. Stimulation intensity was set at 2 mA and delivered for 20 min. ERPs were assessed in an auditory oddball task before (T0) and 5 (T1) and 30 min (T2) after tDCS offset.
RESULTS


In condition iii, spino-cerebellar tDCS, the N100 component at T2 increased in amplitude by 60% (p = 0.019), whereas the sham stimulation left the N100 amplitude unchanged (p > 0.05).
CONCLUSION


The N100 wave reflects pre-attentive processes and correlates with arousal due to a specific stimuli and selective attention. Because spino-cerebellar tDCS induces electric fields in the brainstem, the facilitation of the N100 may be due to the modulation of the reticular formation. Regardless of the underlying mechanism, spino-cerebellar tDCS can help patients with deficits at the pre-attentive or selective attentional level.",2019,"In condition iii, spino-cerebellar tDCS, the N100 component at T2 increased in amplitude by 60% (p = 0.019), whereas the sham stimulation left the N100 amplitude unchanged (p > 0.05).
","['37 volunteers (11 males and 26 females, aged 20-50 years', 'healthy subjects']","['spinal and cerebellar direct current stimulation (tDCS', 'anodal cerebellar tDCS, with the reference electrode over the right shoulder; ii) anodal spinal tDCS, with the reference electrode over the right shoulder; iii) anodal spinal tDCS with cathodal cerebellar tDCS, and iv) sham stimulation']","['Stimulation intensity', 'auditory oddball task', 'ERPs']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0524468', 'cui_str': 'Structure of right shoulder region'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",37.0,0.0356946,"In condition iii, spino-cerebellar tDCS, the N100 component at T2 increased in amplitude by 60% (p = 0.019), whereas the sham stimulation left the N100 amplitude unchanged (p > 0.05).
","[{'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Ruggiero', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy.""}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ferrucci', 'Affiliation': 'Foundation IRCCS Ca\' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy; ""Aldo Ravelli"" Center for Neurotechnology and Experimental Brain Therapeutics, Dipartimento di Scienze della salute, Università degli Studi di Milano, Milan, Italy; III Neurology Clinic, ASST Santi Paolo e Carlo, Milan, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Bocci', 'Affiliation': '""Aldo Ravelli"" Center for Neurotechnology and Experimental Brain Therapeutics, Dipartimento di Scienze della salute, Università degli Studi di Milano, Milan, Italy; III Neurology Clinic, ASST Santi Paolo e Carlo, Milan, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Nigro', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Vergari', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Marceglia', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy; Dipartimento di Ingegneria e Architettura, University of Trieste, Trieste, Italy.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurophysiology Unit, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Priori', 'Affiliation': '""Aldo Ravelli"" Center for Neurotechnology and Experimental Brain Therapeutics, Dipartimento di Scienze della salute, Università degli Studi di Milano, Milan, Italy; III Neurology Clinic, ASST Santi Paolo e Carlo, Milan, Italy. Electronic address: alberto.priori@unimi.it.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.107231']
1036,29337835,Promethazine and Oral Midazolam Preanesthetic Children Medication.,"AIMS


Several kinds of drugs have been investigated in preschool children as a preanesthetic sedation after various routes of administration for surgeries. This study aims to compare the efficacy of promethazine and oral midazolam for premedication in children aged 3 to 9 years who were scheduled for surgeries.
METHODS


This is a double-blind randomized controlled study conducted on 93 patients between the age of 3 and 9 years at Loresten University of Medical Sciences Teaching Hospital, Khoramabad, Iran. The subjects were grouped into P (promethazine), M (midazolam), and C (control). About 0.3 mg/kg of oral promethazine was administered to patients in group P, 0.5 mg/kg of oral midazolam was administered to patients in group M, and 3 mL of normal saline as placebo was administered to patients in group C. Patient satisfaction, sedation and emotional score, systolic blood pressure (SBP), diastolic blood pressure, respiratory rate (RR), and heart rate (HR) were recorded.
RESULTS


There was no statistically significant difference among the 3 groups. However, the period after medication, it was observed that SBP, diastolic blood pressure, RR, and HR in group C were statistically significantly higher than those in groups M and P. These 2 groups are similar in terms of SBP, RR, and HR. The emotional scores were comparable for the 2 groups. It was between 3.97 ± 0.6 to 1.7 ± 0.5 in group M and from 3.45 ± 1.17 to 2.745 ± 0.997 in group P in a Kruskal-Wallis test.
CONCLUSIONS


This study shows that both test groups reduce stress at the time of anesthetic induction and separation from their parents with similar effect. Both of the anesthetics are easily administered without the necessity of an additional equipment. A shorter period to maximal sedation for midazolam is an advantage, thus, making the drug helpful, mostly in the outpatient setting.",2020,The emotional scores were comparable for the 2 groups.,"['preschool children', 'children aged 3 to 9 years who were scheduled for surgeries', '93 patients between the age of 3 and 9 years at Loresten University of Medical Sciences Teaching Hospital, Khoramabad, Iran']","['midazolam', 'Midazolam Preanesthetic Children Medication', 'Promethazine', 'oral promethazine', 'normal saline as placebo', 'oral midazolam', 'P (promethazine), M (midazolam), and C (control', 'promethazine and oral midazolam']","['satisfaction, sedation and emotional score, systolic blood pressure (SBP), diastolic blood pressure, respiratory rate (RR), and heart rate (HR', 'emotional scores', 'SBP, diastolic blood pressure, RR, and HR', 'SBP, RR, and HR']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",93.0,0.0662825,The emotional scores were comparable for the 2 groups.,"[{'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Nadri', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Mahmoudvand', 'Affiliation': 'Surgery.'}, {'ForeName': 'Nadereh', 'Initials': 'N', 'LastName': 'Taee', 'Affiliation': 'Pediatrics, Faculty of Medicine.'}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Anbari', 'Affiliation': 'Social Determinant of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Beiranvand', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001389']
1037,31610673,[Association between consumption of yerba mate and lipid profile in overweight women].,"Introduction


Introduction: yerba mate is a traditional drink consumed in South America, produced from toasted leaves of Ilex paraguariensis. Several studies have demonstrated its lipid-lowering properties due to the presence of polyphenols and saponins. Objective: to analyze the effect of daily yerba mate consumption on the values of serum lipids and body composition in overweight women. Methods: 119 overweight women between 25 and 50 years were divided into three groups: Mate and Diet (MD), Mate without Diet (M), and Water and Diet (AD). For 12 weeks the M and MD groups were supplemented with mate, while the AD and MD groups maintained a hypocaloric food plan. Anthropometric measurements and blood tests (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) were taken at the beginning and at the end of the study. The statistical analysis was performed using Student's t-test or Wilcoxon's test for paired samples and ANOVA (p < 0.05 was considered significant in all cases). Results: total cholesterol decreased in all groups (10.21 mg/dL in MD, 18.29 mg/dL in M, and 17.63 mg/dL in AD, without differences between groups). LDL-cholesterol decreased in both groups with mate (8.07 mg/dL in MD, 16.04 mg/dL in M, without differences between groups) while HDL-cholesterol decreased in M (2.09 mg/dL). On the other hand, triglycerides fell 10.74 mg/dL in the MD group. Conclusions: a daily intake of mate helps reduce total cholesterol and LDL-cholesterol, and provides a reduction of triglycerides along with a low-calorie diet.",2019,"RESULTS


total cholesterol decreased in all groups (10.21 mg/dL in MD, 18.29 mg/dL in M, and 17.63 mg/dL in AD, without differences between groups).","['overweight women', '119 overweight women between 25 and 50 years']","['Mate and Diet (MD), Mate without Diet (M), and Water and Diet (AD', 'daily yerba mate consumption']","['LDL-cholesterol', 'total cholesterol and LDL-cholesterol', 'Anthropometric measurements and blood tests (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides', 'total cholesterol', 'serum lipids and body composition', 'HDL-cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0874159', 'cui_str': 'Ilex paraguariensis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",119.0,0.0197119,"RESULTS


total cholesterol decreased in all groups (10.21 mg/dL in MD, 18.29 mg/dL in M, and 17.63 mg/dL in AD, without differences between groups).","[{'ForeName': 'María Virginia', 'Initials': 'MV', 'LastName': 'Avena Álvarez', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Diego Nicolás', 'Initials': 'DN', 'LastName': 'Messina', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Corte', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Jessica Anabella', 'Initials': 'JA', 'LastName': 'Mussi Stoizik', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Aldana', 'Initials': 'A', 'LastName': 'Saez', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Boarelli', 'Affiliation': 'Universidad Juan Agustín Maza.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez Elizalde', 'Affiliation': 'Universidad Juan Agustín Maza.'}]",Nutricion hospitalaria,['10.20960/nh.02599']
1038,29278143,Methods for assessing and controlling placebo effects.,"The placebo serves as an indispensable control in many randomized trials. When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect. Various alternative methods have been proposed for analyzing placebo and treatment effects in studies where large placebo effects are expected or have already occurred. This paper presents an overview of methodological work that has been proposed for assessing and/or controlling for placebo effects in randomized trials. Throughout this paper, two main approaches are discussed. The first approach considers designs that represent alternatives to the classical placebo-controlled randomized trial design. Separately, the second approach considers adopting new methods for the statistical analysis of placebo and treatment effects to be implemented after the data have been collected using a classical randomized trial design.",2019,"When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.575292,"When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect.","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': '1 Emotional Brain B.V., Almere, the Netherlands.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Mozer', 'Affiliation': '2 Department of Statistics, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Bloemers', 'Affiliation': '1 Emotional Brain B.V., Almere, the Netherlands.'}]",Statistical methods in medical research,['10.1177/0962280217748339']
1039,31551249,Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes.,"OBJECTIVE


Hepatic-directed vesicle insulin (HDV) uses a hepatocyte-targeting moiety passively attaching free insulin, improving subcutaneous insulin's hepatic biodistribution. We assessed HDV-insulin lispro (HDV-L) versus insulin lispro (LIS) in type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS


Insulin Liver Effect (ISLE-1) was a 26-week, phase 2b, multicenter, randomized, double-blind, noninferiority trial.
RESULTS


Among 176 randomized participants (HDV-L  n  = 118, LIS  n  = 58), the difference in change from baseline A1C was 0.09% (95% CI -0.18% to 0.35%), confirming noninferiority (prespecified margin ≤0.4%). Overall, there were no statistically significant differences between treatments for hypoglycemia or insulin dosing. However, baseline A1C modified the treatment group effect (interaction  P  < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe. Thus, at higher baseline A1C, there was less hypoglycemia and lower insulin dosing with similar A1C outcomes during HDV-L versus LIS, whereas greater risk of hypoglycemia despite similar A1C outcomes and insulin doses was observed with lower baseline A1C. Among poorly controlled participants (A1C ≥8.5%), incidence rates of severe hypoglycemia in the HDV-L and LIS arms were 69 and 97 events/100 person-years, respectively ( P  = 0.03), whereas with A1C <8.5%, respective rates were 191 and 21 events/100 person-years ( P  = 0.001). Similar A1C-dependent trends in hypoglycemia were seen with continuous glucose monitoring. Among poorly controlled participants, bolus insulin doses at end point were ∼25% lower with HDV-L ( P  = 0.02), despite similar A1C outcomes; in better-controlled participants, insulin doses and A1Cs were stable over time in both subgroups. No safety signals were identified.
CONCLUSIONS


Hepatic biodistribution of HDV-L appears to potentiate insulin effect in T1D, with divergent clinical outcomes in hypoglycemia dependent on baseline A1C.",2019,"However, baseline A1C modified the treatment group effect (interaction  P  < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe.",['type 1 diabetes (T1D'],['Hepatic-Directed Prandial Insulin'],"['HDV-insulin lispro (HDV-L) versus insulin lispro (LIS', 'hypoglycemia', 'incidence rates of severe hypoglycemia', 'risk of hypoglycemia despite similar A1C outcomes and insulin doses']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",176.0,0.203641,"However, baseline A1C modified the treatment group effect (interaction  P  < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klonoff', 'Affiliation': 'Mills-Peninsula Medical Center, San Mateo, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Penn', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH.'}, {'ForeName': 'W Blair', 'Initials': 'WB', 'LastName': 'Geho', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Muchmore', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH dmuchmore@diasome.com.'}]",Diabetes care,['10.2337/dc19-0152']
1040,29560806,Impact of music type on motor coordination task performance among introverted and extroverted students.,"Purpose . People are interested in music. In this study, we assessed the impact of music type on objective performance.  Materials and methods . We distributed 64 medical science students in Tehran into four groups: Iranian pop music, traditional music, Mozart's classical music and control groups. All participants performed the two-arm coordination test once without music and once with music (except for the control group), with an interval of 1 week. In the music groups, music was playing during the performance of the test. Participants were categorized as either introverted or extroverted and were distributed equally in the groups.  Results . There was a significant decrease of test time in the second trial, observed in all music groups, and no significant difference identified in the control group. The traditional music group had less difference of mean time compared to the pop music group. The differences in the traditional and classical groups were not significantly different. In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.  Conclusion . Listening to music would enhance the speed of performance. Music with a higher tempo, such as pop music, increased the speed more.",2020,"In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.
CONCLUSION


Listening to music would enhance the speed of performance.","['introverted and extroverted students', 'We distributed 64 medical science students in Tehran into four groups']","[""Iranian pop music, traditional music, Mozart's classical music and control groups"", 'music type']","['test time', 'motor coordination task performance', 'speed of performance', 'mean time']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",64.0,0.0602022,"In the music groups, both extroverted and introverted students decreased their test time significantly after music intervention, but extroverted students decreased more.
CONCLUSION


Listening to music would enhance the speed of performance.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jamshidzad', 'Affiliation': 'School of Public Health, Ilam University of Medical Science, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maghsoudipour', 'Affiliation': 'Department of Ergonomics, University of Social Welfare and Rehabilitation Sciences, Iran.'}, {'ForeName': 'Seyed Abolfazl', 'Initials': 'SA', 'LastName': 'Zakerian', 'Affiliation': 'School of Public Health, Tehran University of Medical Science, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Iran.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Coh', 'Affiliation': 'Department of Ophthalmology, University of California San Francisco, USA.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2018.1455410']
1041,29480399,"The effect of resistant dextrin as a prebiotic on metabolic parameters and androgen level in women with polycystic ovarian syndrome: a randomized, triple-blind, controlled, clinical trial.","INTRODUCTION


Polycystic ovary syndrome (PCOS) is one of the most common abnormalities in women of reproductive age that can lead to a variety of metabolic and reproductive disorders. Studies reveal that a healthy diet is the most effective way for treating the risk factors associated with metabolic disorders and place greater emphasis on the consumption of prebiotic foods. The present study aims to determine the effect of resistant Dextrin on metabolic parameters, including lipid profile, fasting blood glucose (FBS) and high sensitivity C-reactive protein (hsCRP), and androgen levels, including serum levels of dehydroepiandrosterone sulfate (DHEA-S) and free testosterone, as the primary outcomes, and manifestations of PCOS including menstrual cycle irregularity and hirsutism, as the secondary outcomes.
METHODS


This randomized, controlled, triple-blind, clinical trial was conducted on 62 women aged 18-45 in Tabriz, Iran, in 2016-2017. The participants were divided into a prebiotic group and a placebo group using block randomization. The prebiotic group consumed 20 g of resistant dextrin dissolved in a glass of water and the placebo group 20 g of maltodextrin also dissolved in a glass of water on a daily basis for 3 months. To measure the serum lipid profile, FBS, hsCRP, DHEA-S and free testosterone before and 3 months after the intervention, 5-ml blood samples were collected from the participants and analyzed using the ELISA method. The Ferriman-Gallwey scale for assessing hirsutism and a checklist for assessing menstrual cycle characteristics were completed before and 3 months after the intervention. A general linear model was used to analyze the data.
RESULTS


No statistically significant differences were observed between the two groups in terms of sociodemographic characteristics and baseline values. 3 months after the intervention, based on the ANCOVA and after adjusting for the baseline values, the mean serum levels of LDL-C (adjusted mean difference = - 29.79; 95% CI = - 43.37 to - 16.21; P < 0.001), triglyceride (AMD = - 38.50; 95% CI = - 59.73 to - 17.28; P = 0.001), total cholesterol (AMD = - 29.98; 95% CI = - 40.14 to - 19.82; P < 0.001), FBS (AMD = - 11.24; 95% CI = - 15.43 to - 7.06; P < 0.001), hsCRP (AMD = - 1.75; 95% CI = - 2.92 to - 0.57; P = 0.004), DHEA-S (AMD = - 0.7; 95% CI = - 1.34 to - 0.13; P = 0.017) and free testosterone (AMD = - 0.32; 95% CI = - 0.56 to - 0.08; P = 0.010) revealed a statistically significant decrease in the intervention group compared to the placebo group, while the mean serum HDL-C showed a statistically significant increase in this group compared to the placebo group (AMD = 5.82; 95% CI = 2.27-9.37; P = 0.002). 3 months after the intervention, there was a significant difference between the two groups in terms of menstrual cycle intervals and hirsutism (P < 0.001).
CONCLUSION


Resistant dextrin consumption can regulate metabolic parameters and androgen levels and manifestations including hirsutism and menstrual cycle irregularity in women with PCOS.",2019,"3 months after the intervention, there was a significant difference between the two groups in terms of menstrual cycle intervals and hirsutism (P < 0.001).
","['women with PCOS', '62 women aged 18-45 in Tabriz, Iran, in 2016-2017', 'women with polycystic ovarian syndrome']","['prebiotic group consumed 20', 'placebo', 'maltodextrin', 'Resistant dextrin consumption', 'resistant dextrin']","['FBS', 'metabolic parameters, including lipid profile, fasting blood glucose (FBS) and high sensitivity C-reactive protein (hsCRP), and androgen levels, including serum levels of dehydroepiandrosterone sulfate (DHEA-S) and free testosterone, as the primary outcomes, and manifestations of PCOS including menstrual cycle irregularity and hirsutism, as the secondary outcomes', 'total cholesterol', 'menstrual cycle intervals and hirsutism', 'mean serum levels of LDL-C', 'free testosterone', 'triglyceride', 'mean serum HDL-C', 'hsCRP', 'serum lipid profile, FBS, hsCRP, DHEA-S and free testosterone']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0054527', 'cui_str': 'caloreen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0057277', 'cui_str': 'Prasterone Sulfate'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1280464', 'cui_str': 'Manifestation of (qualifier value)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",62.0,0.254515,"3 months after the intervention, there was a significant difference between the two groups in terms of menstrual cycle intervals and hirsutism (P < 0.001).
","[{'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Gholizadeh Shamasbi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Dehgan', 'Affiliation': 'Department of Food Science and Technology, School of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh Charandabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Aliasgarzadeh', 'Affiliation': 'Endocrine Research Center, Imam Reza Medical, Research and Training Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Midwifery Department, Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvandm@tbzmed.ac.ir.'}]",European journal of nutrition,['10.1007/s00394-018-1648-7']
1042,29353534,No detectable effects of acute tryptophan depletion on short-term immune system cytokine levels in healthy adults.,"Objectives:  Recent research suggested an influence of diminished central nervous serotonin (5-HT) synthesis on the leptin axis via immunological mechanisms in healthy adult females. However, studies assessing immunological parameters in combination with dietary challenge techniques that impact brain 5-HT synthesis in humans are lacking.   Methods:  In the present trial, a pilot analysis was conducted on data obtained in healthy adult humans receiving either different dietary acute tryptophan depletion (ATD) challenge or tryptophan (TRP)-balanced control conditions (BAL) to study the effects of reduced central nervous 5-HT synthesis on serum tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β) and IL-6 concentrations. The data of  N  = 35 healthy adults were analysed who were randomly subjected to one of the following two dietary conditions in a double-blind between-subject approach: (1) The Moja-De ATD challenge (ATD), or (2) TRP-balanced control condition for ATD Moja-De (BAL). Serum concentrations for the assessment of relevant parameters (TNF-α, IL-1β and IL-6) and relevant TRP-related characteristics after the respective challenge procedures were assessed at baseline (T0) and in hourly intervals after administration over a period of 6 h (T1-T6).   Results:  The ATD condition did not result in significant changes to cytokine concentrations for the entire study sample, or in male and female subgroups. Depletion of CNS 5-HT via dietary TRP depletion appears to have no statistically significant short-term impact on cytokine concentrations in healthy adults.   Conclusions:  Future research on immunological stressors in combination with challenge techniques will be of value in order to further disentangle the complex interplay between brain 5-HT synthesis and immunological pathways.",2019,Depletion of CNS 5-HT via dietary TRP depletion appears to have no statistically significant short-term impact on cytokine concentrations in healthy adults.  ,"['35 healthy adults', 'healthy adult humans receiving either different', 'healthy adults', 'healthy adult females']","['Moja-De ATD challenge (ATD), or (2) TRP-balanced control condition for ATD Moja-De (BAL', 'dietary acute tryptophan depletion (ATD) challenge or tryptophan (TRP)-balanced control conditions (BAL']","['serum tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β) and IL-6 concentrations', 'cytokine concentrations', 'Serum concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",35.0,0.0665771,Depletion of CNS 5-HT via dietary TRP depletion appears to have no statistically significant short-term impact on cytokine concentrations in healthy adults.  ,"[{'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Hildebrandt', 'Affiliation': 'a Jülich Aachen Research Alliance, JARA Translational Brain Medicine , Aachen , Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Helmbold', 'Affiliation': 'a Jülich Aachen Research Alliance, JARA Translational Brain Medicine , Aachen , Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Linden', 'Affiliation': 'a Jülich Aachen Research Alliance, JARA Translational Brain Medicine , Aachen , Germany.'}, {'ForeName': 'Karl-Josef', 'Initials': 'KJ', 'LastName': 'Langen', 'Affiliation': 'd Institute of Neuroscience and Medicine (INM-4) Research Centre Jülich , Jülich , Germany.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Filss', 'Affiliation': 'e Section JARA-Brain , Jülich-Aachen Research Alliance (JARA) , Jülich , Germany.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Runions', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stewart', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Rao', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Moore', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Mahfouda', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Hugo A E', 'Initials': 'HAE', 'LastName': 'Morandini', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Janice W Y', 'Initials': 'JWY', 'LastName': 'Wong', 'Affiliation': 'g Centre & Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy; School of Medicine, Division of Psychiatry and Clinical Neurosciences and Division of Paediatrics and Child Health , The University of Western Australia , Perth , Australia.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Rink', 'Affiliation': 'l Department of Immunology , RWTH Aachen University Hospital , Aachen , Germany.'}, {'ForeName': 'Florian D', 'Initials': 'FD', 'LastName': 'Zepf', 'Affiliation': 'a Jülich Aachen Research Alliance, JARA Translational Brain Medicine , Aachen , Germany.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2018.1428357']
1043,31615775,"Effects of moderately increased testosterone concentration on physical performance in young women: a double blind, randomised, placebo controlled study.","OBJECTIVE


To investigate the effects of a moderate increase in serum testosterone on physical performance in young, physically active, healthy women.
METHODS


A double blind, randomised, placebo controlled trial was conducted between May 2017 and June 2018 (ClinicalTrials.gov ID: NCT03210558). 48 healthy, physically active women aged 18-35 years were randomised to 10 weeks of treatment with 10 mg of testosterone cream daily or placebo (1:1). All participants completed the study. The primary outcome measure was aerobic performance measured by running time to exhaustion (TTE). Secondary outcomes were anaerobic performance (Wingate test) and muscle strength (squat jump (SJ), counter movement jump (CMJ) and knee extension peak torque). Hormone levels were analysed and body composition assessed by dual energy X-ray absorptiometry.
RESULTS


Serum levels of testosterone increased from 0.9 (0.4) nmol/L to 4.3 (2.8) nmol/L in the testosterone supplemented group. TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045). Wingate average power, which increased by 15.2 W in the testosterone group compared with 3.2 W in the placebo group, was not significantly different between the groups (P=0.084). There were no significant changes in CMJ, SJ and knee extension. Mean change from baseline in total lean mass was 923 g for the testosterone group and 135 g for the placebo group (P=0.040). Mean change in lean mass in the lower limbs was 398 g and 91 g, respectively (P=0.041).
CONCLUSION


The study supports a causal effect of testosterone in the increase in aerobic running time as well as lean mass in young, physically active women.",2020,TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045).,"['48 healthy, physically active women aged 18-35 years', 'young, physically active, healthy women', 'young women', 'young, physically active women']","['placebo', 'testosterone concentration', 'testosterone cream daily or placebo', 'testosterone']","['anaerobic performance (Wingate test) and muscle strength (squat jump (SJ), counter movement jump (CMJ) and knee extension peak torque', 'aerobic performance measured by running time to exhaustion (TTE', 'total lean mass', 'aerobic running time', 'Hormone levels', 'physical performance', 'Serum levels of testosterone', 'TTE', 'CMJ, SJ and knee extension', 'Mean change in lean mass']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C2607857'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",48.0,0.787542,TTE increased significantly by 21.17 s (8.5%) in the testosterone group compared with the placebo group (mean difference 15.5 s; P=0.045).,"[{'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden angelica.linden-hirschberg@sll.se.""}, {'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Elings Knutsson', 'Affiliation': ""Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Helge', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Manne', 'Initials': 'M', 'LastName': 'Godhe', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sports and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Bermon', 'Affiliation': 'Monaco Institute of Sports Medicine, Monaco.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ekblom', 'Affiliation': 'Astrand Laboratory of Work Physiology, The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}]",British journal of sports medicine,['10.1136/bjsports-2018-100525']
1044,31526767,Dopamine replacement improves motor learning of an upper extremity task in people with Parkinson disease.,"BACKGROUND


Dopamine replacement medication has positive effects on existing motor skills for people with Parkinson disease (PD), but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation according to the dopamine overdose hypothesis.
OBJECTIVES


This study aimed to determine whether dopamine replacement medication (i.e. levodopa) affects: learning of a novel upper extremity task, decrements in skill following withdrawal of practice, the rate of learning, and the transfer of movement skill to untrained upper extremity tasks compared to training ""off"" medication, in people with PD.
METHODS


Participants with mild-moderate PD (Hoehn and Yahr stage 2) were randomized to train ""on"" (n = 12) or ""off"" (n = 11) levodopa medication. Participants practiced 10 blocks of five trials of a functional motor task with their non-dominant upper extremity over three consecutive days (acquisition period), followed by a single block of five trials two and nine days later. Participants were also assessed ""on"" levodopa with two transfer tasks (the nine-hole peg test and a functional dexterity task) prior to any practice and nine days after the end of the acquisition period.
RESULTS


Participants who practiced ""on"" levodopa medication learned the upper extremity task to a greater extent that those who practiced ""off"" medication, as determined by retained performance two days after practice. Skill decrement and skill transfer were not significantly different between groups. Rate of learning was unable to be modelled in this sample.
CONCLUSIONS


Levodopa medication improved the learning of an upper extremity task in people with mild-moderate PD.",2020,Skill decrement and skill transfer were not significantly different between groups.,"['people with mild-moderate PD', 'Participants who practiced ""on"" levodopa medication learned the', 'Participants with mild-moderate PD (Hoehn and Yahr stage 2', 'people with Parkinson disease', 'people with Parkinson disease (PD']","['Dopamine replacement', 'dopamine replacement medication (i.e. levodopa', 'Levodopa medication', 'Dopamine replacement medication', 'train ""on"" (n\u202f=\u202f12) or ""off"" (n\u202f=\u202f11) levodopa medication', 'functional motor task with their non-dominant upper extremity']","['Skill decrement and skill transfer', 'upper extremity task', 'learning of an upper extremity task', 'Rate of learning', 'motor learning of an upper extremity task']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",10.0,0.136439,Skill decrement and skill transfer were not significantly different between groups.,"[{'ForeName': 'Serene S', 'Initials': 'SS', 'LastName': 'Paul', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, 75 East St, Lidcombe, NSW, 2141, Australia. Electronic address: serene.paul@sydney.edu.au.'}, {'ForeName': 'Leland E', 'Initials': 'LE', 'LastName': 'Dibble', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Genevieve N', 'Initials': 'GN', 'LastName': 'Olivier', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Department of Physical Therapy, University of Arkansas for Medical Sciences, 1125 N College Ave, Fayetteville, AR, 72703, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Duff', 'Affiliation': ""Center for Alzheimer's Care, Imaging & Research, Department of Neurology, University of Utah, 650 Komas Dr 106A, Salt Lake City, UT, 84108, USA.""}, {'ForeName': 'Sydney Y', 'Initials': 'SY', 'LastName': 'Schaefer', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA; Department of Biological and Health Systems Engineering, Arizona State University, 501 E Tyler Mall, MC 9709, Tempe, AZ, 85287, USA.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112213']
1045,29254398,"Impact of Latin Dance on Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior Among Latinos Attending an Adult Day Center.","Objective:  The aim of this study was to determine whether a Latin dance program with sedentary behavior information would have an impact on physical activity, cardiorespiratory fitness (CRF), and sedentary behavior among older Latinos attending an adult day center (ADC).  Method : Participants ( N  = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8) were randomized into a dance or wait-list control group. Participants wore an accelerometer and inclinometer and completed a sedentary behavior questionnaire, and a nonexercise equation was used to calculate CRF.  Results : Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.  Discussion : Future studies may consider implementing behavioral strategies during midpoint of the intervention to encourage participants attending an ADC to maintain physical activity and sedentary behavior changes.",2019,"RESULTS


Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.
","['older Latinos attending an adult day center (ADC', 'Latinos Attending an Adult Day Center', 'Participants ( N = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8']",['dance or wait-list control group'],"['physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior', 'Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior', 'physical activity, cardiorespiratory fitness (CRF), and sedentary behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0297971,"RESULTS


Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention.
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Aguiñaga', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago, USA.'}]",Journal of aging and health,['10.1177/0898264317733206']
1046,31582358,"Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial.","BACKGROUND


Since the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial.
METHODS


This randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18. Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation. Pregnant and breastfeeding women were excluded, as well as any patients for whom the treatment would present a health risk. Separate randomisation schedules were generated for each participating clinical site using permuted block randomisation. Treatment assignments were obtained using a web-based application by the site pharmacist who then masked the solution for infusion. Patients and investigators were masked to study treatment. The primary endpoint was a six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities after discharge. The choice of day 7 was based on haemagglutination inhibition titres from a pilot study. It was analysed with a proportional odds model, using all six categories to estimate a common odds ratio (OR). An OR greater than 1 indicated that, for a given category, patients in the hIVIG group were more likely to be in a better category than those in the placebo group. Prespecified primary analyses for safety and efficacy were based on patients who received an infusion and for whom eligibility could be confirmed. This trial is registered with ClinicalTrials.gov, NCT02287467.
FINDINGS


313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018. We also used data from 16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014. 168 patients were randomly assigned to the hIVIG group and 161 to the placebo group. 21 patients were excluded (12 from the hIVIG group and 9 from the placebo group) because they did not receive an infusion or their eligibility could not be confirmed. Thus, 308 were included in the primary analysis. hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres. Based on the proportional odds model, the OR on day 7 was 1·25 (95% CI 0·79-1·97; p=0·33). In subgroup analyses for the primary outcome, the OR in patients with influenza A was 0·94 (0·55-1·59) and was 3·19 (1·21-8·42) for those with influenza B (interaction p=0·023). Through 28 days of follow-up, 47 (30%) of 156 patients in the hIVIG group and in 45 (30%) of 152 patients in the placebo group had the composite safety outcome of death, a serious adverse event, or a grade 3 or 4 adverse event (hazard ratio [HR] 1·06, 95% CI 0·70-1·60; p=0·79). Six (4%) patients in the hIVIG group and five (3%) in the placebo group died, but these deaths were not necessarily related to treatment.
INTERPRETATION


When administered alongside standard care (most commonly oseltamivir), hIVIG was not superior to placebo for adults hospitalised with influenza infection. By contrast with our prespecified subgroup hypothesis that hIVIG would result in more favourable responses in patients with influenza A than B, we found the opposite effect. The clinical benefit of hIVIG for patients with influenza B is supported by antibody affinity analyses, but confirmation is warranted.
FUNDING


NIAID and NIH. Partial support was provided by the Medical Research Council (MRC_UU_12023/23) and the Danish National Research Foundation.",2019,hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres.,"['21 patients were excluded (12 from the hIVIG group and 9 from the', 'adults hospitalised with influenza infection', '313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018', '45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18', '16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014', 'Pregnant and breastfeeding women', 'patients with influenza B', 'adults with influenza A or B infection (FLU-IVIG', 'Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation', 'patients with influenza infection', '168 patients', 'Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned ']","['placebo', 'saline placebo (placebo', 'Anti-influenza hyperimmune intravenous immunoglobulin', 'standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75']","['six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities', 'haemagglutination inhibition titres', 'safety and efficacy', 'composite safety outcome of death, a serious adverse event, or a grade 3 or 4 adverse event (hazard ratio [HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0249692', 'cui_str': 'human immunodeficiency virus hyperimmune globulin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0249692', 'cui_str': 'human immunodeficiency virus hyperimmune globulin'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",313.0,0.679544,hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres.,"[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: rdavey@niaid.nih.gov.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández-Cruz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Servicio de Immunología Clínica, Madrid, Spain.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Markowitz', 'Affiliation': 'Henry Ford Hospital, Division of Infectious Diseases, Detroit, MI, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wentworth', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gordin', 'Affiliation': 'Veteran Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kan', 'Affiliation': 'Veteran Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': 'The Kirby Institute, University of New South Wales Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Riska', 'Affiliation': 'Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; The HIV Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': 'Mayo Clinic Hospital, Saint Marys Campus, Rochester, MN, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'CHIP Centre of Excellence for Health, Immunity, and Infections, Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30253-X']
1047,31294771,Incidence of New Choroidal Neovascularization in Fellow Eyes of Patients With Age-Related Macular Degeneration Treated With Intravitreal Aflibercept or Ranibizumab.,"Importance


Incidence of conversion to neovascular age-related macular degeneration (nAMD) in untreated fellow eyes of patients who are treated for nAMD in 1 eye with anti-vascular endothelial growth factor agents provides important prognostic information to clinically manage patients.
Objective


To investigate the association of treatment assignment (intravitreal aflibercept vs ranibizumab) and baseline characteristics with fellow eye conversion to nAMD in the VEGF (Vascular Endothelial Growth Factor) Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies.
Design, Setting, and Participants


This post hoc analysis of the VIEW 1 and VIEW 2 studies (randomized, double-masked, active-controlled, multicenter, 96-week, phase 3 trials comparing the efficacy and safety of intravitreal aflibercept in 2457 patients with treatment-naive eyes with nAMD) analyzed a subgroup of participants treated for nAMD in 1 eye who had untreated fellow eyes without neovascularization at baseline. All participants in the VIEW studies were included in 1 of 4 groups: ranibizumab, 0.5 mg, every 4 weeks; aflibercept, 2 mg, every 4 weeks; aflibercept, 0.5 mg, every 4 weeks; or aflibercept, 2 mg, every 8 weeks after 3 injections at 4-week intervals. Data collection in the VIEW studies occurred from July 2007 to August 2011; the data analysis presented in this report took place from April 2016 to November 2018.
Interventions


Patients received no treatment in the fellow eyes unless after conversion to nAMD, when any treatment approved by heath authorities was given per the investigators' discretion.
Main Outcomes and Measures


Incidence of conversion to nAMD in patients with untreated fellow eyes that had not had clinical signs of neovascularization at baseline.
Results


A total of 1561 participants were included in this analysis. At 96 weeks, 375 patients (24.0%) experienced cases of conversion to neovascular disease in the fellow eye, including 107 of the 399 individuals who received ranibizumab, 0.5 mg, every 4 weeks; 93 of the 387 individuals who received aflibercept, 2 mg, every 4 weeks; 84 of the 387 individuals who received aflibercept, 0.5 mg, every 4 weeks; and 91 of the 388 individuals who received aflibercept, 2 mg, every 8 weeks after 3 doses at 4-week intervals. The rates were 18.1, 16.2, 14.7, and 16.0 per 100 patient-years at risk at week 96, respectively. On multivariate analysis, fellow eye conversion was associated with increasing patient age (per 10 years) at baseline (hazard ratio [HR], 1.20 [95% CI, 1.05-1.36]), female sex (HR, 1.32 [95% CI, 1.06-1.63]), intraretinal fluid in the study eye at baseline (HR, 1.28 [95% CI, 1.02-1.61]), and increasing choroidal neovascularization lesion size (per 10 mm2) in the study eye at baseline (HR, 1.29 [95% CI, 1.06-1.57]). Rates of fellow eye conversion were similar with either of the treatments.
Conclusions and Relevance


In this secondary analysis of randomized clinical trial data, patients with active nAMD in 1 eye appeared to have a high risk for fellow eye conversion. Such patients should be monitored closely.",2019,"At 96 weeks, 375 patients (24.0%) experienced cases of conversion to neovascular disease in the fellow eye, including 107 of the 399 individuals who received ranibizumab, 0.5 mg, every 4 weeks; 93 of the 387 individuals who received aflibercept, 2 mg, every 4 weeks; 84 of the 387 individuals who received aflibercept, 0.5 mg, every 4 weeks; and 91 of the 388 individuals who received aflibercept, 2 mg, every 8 weeks after 3 doses at 4-week intervals.","['All participants in the VIEW studies were included in 1 of 4 groups', 'neovascular age-related macular degeneration (nAMD) in untreated fellow eyes of patients who are treated for nAMD in 1 eye with', 'Fellow Eyes of Patients With Age-Related Macular Degeneration Treated With', 'Trap-Eye', 'A total of 1561 participants were included in this analysis', '2457 patients with treatment-naive eyes with nAMD) analyzed a subgroup of participants treated for nAMD in 1 eye who had untreated fellow eyes without neovascularization at baseline', 'patients with active nAMD in 1 eye appeared to have a high risk for fellow eye conversion']","['ranibizumab', 'intravitreal aflibercept', 'aflibercept vs ranibizumab', 'anti-vascular endothelial growth factor agents', 'Intravitreal Aflibercept or Ranibizumab', 'aflibercept']","['choroidal neovascularization lesion size', 'clinical signs of neovascularization', 'Measures\n\n\nIncidence of conversion to nAMD', 'VEGF (Vascular Endothelial Growth Factor', 'efficacy and safety', 'Rates of fellow eye conversion']","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]",1561.0,0.262611,"At 96 weeks, 375 patients (24.0%) experienced cases of conversion to neovascular disease in the fellow eye, including 107 of the 399 individuals who received ranibizumab, 0.5 mg, every 4 weeks; 93 of the 387 individuals who received aflibercept, 2 mg, every 4 weeks; 84 of the 387 individuals who received aflibercept, 0.5 mg, every 4 weeks; and 91 of the 388 individuals who received aflibercept, 2 mg, every 8 weeks after 3 doses at 4-week intervals.","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Vitreous Retina Macula Consultants of New York, New York.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Avery', 'Affiliation': 'California Retina Consultants, Santa Barbara.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'K Bailey', 'Initials': 'KB', 'LastName': 'Freund', 'Affiliation': 'Vitreous Retina Macula Consultants of New York, New York.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.1947']
1048,31607204,A prospective open-label trial of long-acting liquid methylphenidate for the treatment of attention deficit/hyperactivity disorder in intellectually capable adults with autism spectrum disorder.,"Objectives:  This treatment trial is aimed at assessing the short-term tolerability and efficacy of liquid-formulation extended-release methylphenidate (MPH-ER) for the treatment of attention deficit/hyperactivity disorder (ADHD) in adults with high-functioning autism spectrum disorder (HF-ASD). Methods:  A 6-week open-label trial (ClinicalTrials.gov: NCT02096952) was conducted in 15 HF-ASD adults (mean age 24.9 ± 4.6; male, 12 (80%)) suffering from moderate-severe ADHD. MPH-ER was administered based on a flexible titration schedule. Efficacy was assessed on clinician- and self-rated measures. Tolerability was assessed by documenting treatment-emergent adverse events (AEs) and other safety measures. Results:  Short-term MPH-ER treatment was associated with significant improvement in ADHD severity (Adult ADHD Investigator Symptom Report Scale (AISRS) mean change (MC), -22.8 ± 8.8,  P  < 0.001; Adult ADHD Self-Report Scale (ASRS) MC, -8.2 ± 15.3,  P  < 0.001). Twelve (80%) participants were deemed responders, based on ≥30% reduction in AISRS score and an ADHD Clinical Global Impression-Improvement score ≤2. MPH-ER was well-tolerated (treatment-limiting AEs, 1/15; severe AEs, 1/15) at mean dose of 48.7 ± 15 mg/day. AEs were transient and experienced by 13/15 (87%) participants at mild to moderate severity. Frequently reported AEs were as typically expected (headache (53%), insomnia (33%), anxiety (33%), decreased appetite (27%)). Conclusions:  Our findings suggest that MPH-ER is effective and well-tolerated in the treatment of ADHD in HF-ASD adults.",2020,"mean change [MC]: -22.8 ± 8.8, p < 0.001; Adult ADHD Self-Report Scale [ASRS]","['15 HF-ASD adults (mean age: 24.9\u2009±\u20094.6; male: 12 [80%]) suffering from moderate-severe ADHD', 'Intellectually Capable Adults with Autism Spectrum Disorder', 'adults with high-functioning autism spectrum disorder (HF-ASD']","['Long-Acting Liquid Methylphenidate', 'liquid-formulation extended-release methylphenidate (MPH-ER', 'MC']","['ADHD severity (Adult ADHD Investigator Symptom Report Scale [AISRS', 'AISRS score and an ADHD Clinical Global Impression-Improvement score ≤2', 'Tolerability', 'Efficacy', 'Adult ADHD Self-Report Scale [ASRS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.0642569,"mean change [MC]: -22.8 ± 8.8, p < 0.001; Adult ADHD Self-Report Scale [ASRS]","[{'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wozniak', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'T Atilla', 'Initials': 'TA', 'LastName': 'Ceranoglu', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Yule', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Surman', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Galdo', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Hoskova', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Belser', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2019.1679392']
1049,31592728,Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.,"BACKGROUND


In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.
METHODS AND RESULTS


Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.
CONCLUSIONS


With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.",2019,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","['patients with iliofemoral DVT', 'Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis', 'patients with acute deep vein thrombosis (DVT', '692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355', 'Patients With Proximal Deep Vein Thrombosis']","['Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis', 'Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['costs', 'Cost-Effectiveness', 'Utility scores', 'mean costs of the initial procedure', 'lifetime costs', 'Health state utilities', 'index hospitalization', 'incremental cost-effectiveness ratio for PCDT', 'lifetime incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",692.0,0.13536,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Khaja', 'Initials': 'K', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology (J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.Z.G.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Newton-Wellesley Hospital, Newton, MA (M.R.J.).'}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Interventional Institute at Holy Name Medical Center, Teaneck, NJ (K.H.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Brady', 'Affiliation': 'Thomas Jefferson University and Einstein Health Care Network, Philadelphia, PA (P.S.B.).'}, {'ForeName': 'Karun', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ""Children's National Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC (K.S.).""}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Black', 'Affiliation': 'Utah Valley Hospital/Intermountain Healthcare and IVC Vein and Interventional Center, Provo (C.M.B.).'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005659']
1050,31204604,Family caregivers' perspectives on communication with cancer care providers.,"Purpose/Objectives:  Family caregivers of individuals living with cancer are often highly involved in communication with healthcare teams, yet little is known about their experiences, needs, and preferences in this role. To address this gap in the knowledge base, researchers sought to explore family caregivers' perspectives on communication with oncology care providers.  Design and Methods:  Researchers conducted a secondary inductive thematic analysis of qualitative interviews originally collected as part of a randomized clinical trial of a supportive intervention for family caregivers of patients with cancer ( N  = 63).  Participants:  Participants were family caregivers of adult patients with cancer. Most were patients' spouses/long-term partners (52.3%) or adult children/grandchildren (29.2%). Caregivers of patients with all cancer types and stages of disease progression were eligible for study enrollment.  Findings:  Caregivers valued communication with healthcare providers who were attentive, genuine, broadly focused on patients and caregivers' experiences, sensitive to unmet information needs, and responsive to the potentially different communication preferences of patients and caregivers.  Interpretation:  Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  Implications for Psychosocial Oncology Practice:  Psychosocial oncology providers' strong orientation to the biopsychosocial and spiritual aspects of cancer care delivery make them uniquely positioned to support family caregivers. Findings suggest that providers should explicitly communicate their commitment to both patient and family care, involve family caregivers in psychosocial assessment activities and subsequent intervention, and strive to honor patients and caregivers' potentially different communication preferences.",2019,"Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  ","['Family caregivers of individuals living with cancer', 'Participants were family caregivers of adult patients with cancer', 'Participants', 'Caregivers of patients with all cancer types and stages of disease progression were eligible for study enrollment', 'family caregivers of patients with cancer ( N \u2009=\u200963']",['supportive intervention'],[],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449385', 'cui_str': 'Staging of disease (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],,0.0250866,"Family caregivers expressed a strong preference for person-centered communication, conceptualized as communication that helps healthcare providers meet the needs of patients and caregivers both as individuals and as an interdependent unit of care, and that acknowledges individuals' experiences beyond their prescribed roles of ""cancer patient"" and ""caregiver.""  ","[{'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Craig', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Parker Oliver', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Ruggeri', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Brunk', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Goldstein', 'Affiliation': 'School of Medicine, University of Missouri , Columbia , Missouri , USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'School of Nursing, University of Pennsylvania , Philadelphia , Pennsylvania , USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2019.1624674']
1051,31165898,A cluster randomized controlled trial to reduce office workers' sitting time: effect on productivity outcomes.,"Objective This study aimed to evaluate the impact of the Stand Up Victoria intervention - a multicomponent workplace intervention that successfully reduced workplace sitting - on productivity in the short- and longer-term. Methods Desk-based workers [5-39 per worksite; 68% women; mean age 45.6 (standard deviation 9.4) years] were cluster randomized by office worksite to receive intervention (7 worksites, 136 workers) or control (7 worksites, 95 workers). The intervention used organizational-, environmental-, and individual-level approaches to address workplace sitting. Productivity outcomes were measured via the Health and Work Questionnaire (HWQ; 10 outcomes) and Work Limitations Questionnaire (WLQ; 5 outcomes), administered at 0 (baseline), 3 (initial), and 12 (long-term) months. Intervention effects were assessed by linear mixed models, accounting for repeated measures and clustering, baseline values, and potential confounders. Evaluable case and multiple imputation analyses were used. Results At 12 months, trends for improvement were observed in the HWQ non-work satisfaction subscale (P=0.053) and stress item (P=0.086). Intervention effects on remaining outcomes for the HWQ were small and non-significant at both timepoints. At 3 months, intervention effects showed significant improvements in the WLQ mental demands subscale (P=0.043). At 12 months, intervention effects showed significant (P<0.05) small-to-moderate improvements in four WLQ outcomes (weighted total score, time-, mental-, and output demands), with physical demands showing a small significant worsening. Conclusions were robust to missing data assumptions. Conclusions The intervention improved some measures of productivity at 12 months, providing important evidence to the business case supporting workplace sitting-reduction interventions.",2019,"At 3 months, intervention effects showed significant improvements in the WLQ mental demands subscale (P=0.043).",['Methods Desk-based workers [5-39 per worksite; 68% women; mean age 45.6 (standard deviation 9.4) years'],"['organizational-, environmental-, and individual-level approaches to address workplace sitting', 'Stand Up Victoria intervention - a multicomponent workplace intervention']","['WLQ mental demands subscale', 'Productivity outcomes', 'HWQ non-work satisfaction subscale', 'WLQ outcomes (weighted total score, time-, mental-, and output demands', 'workplace sitting - on productivity', 'Health and Work Questionnaire (HWQ; 10 outcomes) and Work Limitations Questionnaire (WLQ; 5 outcomes), administered at 0 (baseline), 3 (initial']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0600275,"At 3 months, intervention effects showed significant improvements in the WLQ mental demands subscale (P=0.043).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Peterman', 'Affiliation': 'Deakin Melbourne Burwood Campus, 221 Burwood Hwy, Burwood VIC 3125, Australia. tony.lamontagne@deakin.edu.au.'}, {'ForeName': 'Genevieve N', 'Initials': 'GN', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Elisabeth Ah', 'Initials': 'EA', 'LastName': 'Winkler', 'Affiliation': ''}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': ''}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Eakin', 'Affiliation': ''}, {'ForeName': 'Sheleigh P', 'Initials': 'SP', 'LastName': 'Lawler', 'Affiliation': ''}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': ''}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'LaMontagne', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3820']
1052,28752473,Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.,"INTRODUCTION


Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization.
OBJECTIVE


The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance.
METHODS


We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015.
RESULTS


From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at daily doses of 1200 mg. Other adverse drug reactions reported in post-marketing surveillance are seizure (5.8%), dizziness (4.1%), rash (2.6%), and fatigue (2.1%). The safety profile of eslicarbazepine acetate in renal and hepatic impairment subjects (phase I studies) and in elderly patients (phase III study) did not raise any specific concern.
CONCLUSION


After 6 years of post-marketing surveillance, eslicarbazepine acetate maintains a similar safety profile to that observed in pivotal clinical studies.",2017,No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients.,"['6\xa0years of post-marketing surveillance', 'adults with partial-onset seizures with or without secondary generalization', 'all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015', 'Adults with Refractory Focal-Onset Seizures', 'renal and hepatic impairment subjects (phase I studies) and in elderly patients (phase III study', 'special populations of patients aged ≥65\xa0years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112', 'adults']","['eslicarbazepine acetate', 'Eslicarbazepine Acetate', 'Eslicarbazepine acetate', 'placebo']","['serious adverse events and individual serious adverse events', 'Dizziness, somnolence, headache, and nausea', 'Hyponatremia', 'incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events', 'adverse drug reaction', 'dizziness', 'rash']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",,0.247671,No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gama', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal. helena.gama@bial.com.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Vieira', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Graça', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal.'}, {'ForeName': 'Luís M', 'Initials': 'LM', 'LastName': 'Magalhães', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'Department of Research and Development, BIAL-Portela & Cª, S.A., 4745-457, Coronado (S. Romão e S. Mamede), Portugal.'}]",Drug safety,['10.1007/s40264-017-0576-4']
1053,31587569,Outcomes of Ultrasound-Guided Gastrocnemius Injection With Botulinum Toxin for Chronic Plantar Fasciitis.,"BACKGROUND


The objective of this study was to determine whether the injection of botulinum toxin A (BTA) in the medial head of the gastrocnemius muscle could yield improvements in function and disability in patients with chronic plantar fasciitis with follow-up 12 months after treatment.
METHODS


Thirty-two patients with chronic plantar fasciitis were included in the study and randomly allocated to the BTA and placebo groups. The visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) scores were used to evaluate pain levels pre- and postinjection as well as function of the foot, respectively. Patients were also asked to rate their treatment satisfaction 1 year after injection. The range of dorsiflexion was measured before and 12 months after the injection.
RESULTS


At the 12-month follow-up, the mean VAS decreased from 7.8 to 4 in the placebo group and from 8 to 0.33 in the BTA group. Furthermore, the mean AOFAS scores increased from 48.4 to 65.3 in the placebo group and from 45.5 to 90.6 in the BTA group. The postinjection scores in the BTA group were significantly higher than those in the placebo group ( P  < .001). Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
CONCLUSION


In patients with chronic plantar fasciitis, the use of BTA had a positive effect on improvement in pain and foot function 1 year after treatment.
LEVEL OF EVIDENCE


Level I, prospective randomized controlled trial.",2020,"Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
","['Chronic Plantar Fasciitis', 'patients with chronic plantar fasciitis', 'Thirty-two patients with chronic plantar fasciitis', 'patients with chronic plantar fasciitis with follow-up 12 months after treatment']","['placebo', 'BTA and placebo', 'botulinum toxin A (BTA', 'Ultrasound-Guided Gastrocnemius Injection With Botulinum Toxin']","['range of dorsiflexion', 'Patient satisfaction', 'mean AOFAS scores', 'pain and foot function', 'mean VAS', 'visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) scores', 'postinjection scores']","[{'cui': 'C1136148', 'cui_str': 'Heel Spur Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",32.0,0.0972854,"Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
","[{'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Abbasian', 'Affiliation': 'Department of Orthopedics, Akhtar Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Baghbani', 'Affiliation': 'Department of Orthopedics, Akhtar Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Barangi', 'Affiliation': 'Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Paul Gilbert', 'Initials': 'PG', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Orthopaedics, Inselspital, University Hospital of Berne, Berne, Switzerland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Ebrahimpour', 'Affiliation': 'Department of Orthopedics, Taleghani Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, Berne, Switzerland.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hashemi', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Foot & ankle international,['10.1177/1071100719875220']
1054,31581959,The effects of omega-3 fatty acids on neuropsychological functioning and brain morphology in mid-life adults: a randomized clinical trial.,"BACKGROUND


The diet of most adults is low in fish and, therefore, provides limited quantities of the long-chain, omega-3 fatty acids (LCn-3FAs), eicosapentaenoic and docosahexaenoic acids (EPA, DHA). Since these compounds serve important roles in the brain, we sought to determine if healthy adults with low-LCn-3FA consumption would exhibit improvements in neuropsychological performance and parallel changes in brain morphology following repletion through fish oil supplementation.
METHODS


In a randomized, controlled trial, 271 mid-life adults (30-54 years of age, 118 men, 153 women) consuming ⩽300 mg/day of LCn-3FAs received 18 weeks of supplementation with fish oil capsules (1400 mg/day of EPA and DHA) or matching placebo. All participants completed a neuropsychological test battery examining four cognitive domains: psychomotor speed, executive function, learning/episodic memory, and fluid intelligence. A subset of 122 underwent neuroimaging before and after supplementation to measure whole-brain and subcortical tissue volumes.
RESULTS


Capsule adherence was over 95%, participant blinding was verified, and red blood cell EPA and DHA levels increased as expected. Supplementation did not affect performance in any of the four cognitive domains. Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels. No changes were observed in any indicator of brain morphology.
CONCLUSIONS


In healthy mid-life adults reporting low-dietary intake, supplementation with LCn-3FAs in moderate dose for moderate duration did not affect neuropsychological performance or brain morphology. Whether salutary effects occur in individuals with particularly low-DHA exposure requires further study.",2019,"Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels.","['individuals with particularly low-DHA', 'mid-life adults', '271 mid-life adults (30-54 years of age, 118 men, 153 women) consuming ⩽300 mg/day of LCn-3FAs received 18 weeks of', 'healthy adults with low-LCn-3FA consumption', 'participants with low-baseline DHA levels']","['placebo, fish oil supplementation', 'supplementation with fish oil capsules (1400 mg/day of EPA and DHA) or matching placebo', 'omega-3 fatty acids']","['neuropsychological functioning and brain morphology', 'neuropsychological test battery examining four cognitive domains: psychomotor speed, executive function, learning/episodic memory, and fluid intelligence', 'red blood cell EPA and DHA levels', 'executive function', 'Capsule adherence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]",271.0,0.572238,"Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels.","[{'ForeName': 'Regina L', 'Initials': 'RL', 'LastName': 'Leckie', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lehman', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gianaros', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}, {'ForeName': 'Dora C H', 'Initials': 'DCH', 'LastName': 'Kuan', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Manuck', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Ryan', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Yao', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Muldoon', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Psychological medicine,['10.1017/S0033291719002617']
1055,31607677,"Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Statins have beneficial effects on intrahepatic circulation and decrease portal hypertension and rifaximin modulates the gut microbiome and might prevent bacterial translocation in patients with cirrhosis. Therefore, this drug combination might be of therapeutic benefit in patients with decompensated cirrhosis. However, there is concern regarding the safety of statins in patients with decompensated cirrhosis. We assessed the safety of two different doses of simvastatin, in combination with rifaximin, in patients with decompensated cirrhosis.
METHODS


We did a double-blind, randomised, placebo-controlled, phase 2 trial in patients with decompensated cirrhosis and moderate-to-severe liver failure from nine university hospitals in six European countries (Italy, France, Holland, Germany, the UK, and Spain). Patients older than 18 years with Child-Pugh class B or C disease were eligible. We randomly assigned patients (1:1:1) to receive either simvastatin 40 mg/day plus rifaximin 1200 mg/day, simvastatin 20 mg/day plus rifaximin 1200 mg/day, or placebo of both medications for 12 weeks. Randomisation was stratified according to Child-Pugh class (B vs C) and restricted using blocks of multiples of three. The primary endpoint was development of liver or muscle toxicity, as defined by changes in liver aminotransferases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), alkaline phosphastase, and creatine kinase. The study is registered with the European Union Clinical Trials Register, 2016-004499-23, and with ClinicalTrials.gov, NCT03150459.
FINDINGS


The study recruitment period was between July 28, 2017, and Jan 2, 2018. Follow-up finished on March 12, 2018. 50 patients were randomly assigned to simvastatin 40 mg/day plus rifaximin 1200 mg/day (n=18), simvastatin 20 mg/day plus rifaximin 1200 mg/day (n=16), or placebo of both medications (n=16). Six patients (two from each group) were excluded. Therefore, the full analysis set included 44 patients (16 in the simvastatin 40 mg/day plus rifaximin 1200 mg/day group, 14 in the simvastatin 20 mg/day plus rifaximin mg/day group, and 14 in the placebo group). After a safety analyses when the first ten patients completed treatment, treatment was stopped prematurely in the simvastatin 40 mg/day plus rifaximin group due to recommendations by the data safety monitoring board. Patients in the simvastatin 40 mg/day plus rifaximin group showed a significant increase in AST and ALT compared with the placebo group (mean differences between the groups at the end of treatment for AST 130 IU/L [95% CI 54 to 205; p=0·0009] and for ALT 61 IU/L [22 to 100; p=0·0025]. We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]). We observed no significant differences in alkaline phosphatase between the the simvastatin 40 mg/day plus rifaximin or the simvastatin 20 mg/day plus rifaximin groups compared with placebo. Patients in the simvastatin 40 mg/day plus rifaximin group showed an increase in creatine kinase at the end of treatment compared with patients in the placebo group (1009 IU/L [208 to 1809]; p=0·014). We observed no significant changes in creatine kinase in the simvastatin 20 mg/day plus rifaximin group (4·2 IU/L [-804 to 813]; p=0·992). Three (19%) patients in the simvastatin 40 mg/day group developed liver and muscle toxicity consistent with rhabdomyolysis. The number of patients who stopped treatment because of adverse events was significantly higher in the simvastatin 40 mg/day plus rifaximin group (nine [56%] of 16 patients) compared with the other two groups (two [14%] of 14 for both groups; p=0·017). There were no serious unexpected adverse reactions reported during the study.
INTERPRETATION


Treatment with simvastatin 40 mg/day plus rifaximin in patients with decompensated cirrhosis was associated with a significant increase in adverse events requiring treatment withdrawal, particularly rhabdomyolysis, compared with simvastatin 20 mg/day plus rifaximin. We recommend simvastatin 20 mg/day as the dose to be used in studies investigating the role of statins in patients with decompensated cirrhosis.
FUNDING


Horizon 20/20 European programme.",2020,We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]).,"['patients with decompensated cirrhosis', '50 patients', 'Six patients (two from each group) were excluded', 'The study recruitment period was between July 28, 2017, and Jan 2, 2018', 'patients with decompensated cirrhosis and moderate-to-severe liver failure from nine university hospitals in six European countries (Italy, France, Holland, Germany, the UK, and Spain', 'Patients older than 18 years with Child', 'patients with cirrhosis', '44 patients (16 in the']","['rifaximin', 'placebo of both medications', 'simvastatin 40 mg/day plus rifaximin 1200 mg/day, simvastatin 20 mg/day plus rifaximin 1200 mg/day, or placebo', 'simvastatin', 'simvastatin 40 mg/day plus rifaximin', 'simvastatin plus rifaximin', 'simvastatin 20 mg/day plus rifaximin', 'placebo']","['creatine kinase', 'adverse events', 'liver and muscle toxicity', 'development of liver or muscle toxicity, as defined by changes in liver aminotransferases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), alkaline phosphastase, and creatine kinase', 'alkaline phosphatase', 'adverse reactions', 'AST and ALT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1619727', 'cui_str': 'Decompensated cirrhosis of liver (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027778', 'cui_str': 'Holland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1596096', 'cui_str': 'Simvastatin 20 MG [Zocor]'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",44.0,0.284469,We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pose', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Napoleone', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Institute of Liver and Digestive Health, University College London, London, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Campion', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Jimenez', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron and Vall d'Hebron Research Unit (VHIR), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Piano', 'Affiliation': 'Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Roux', 'Affiliation': 'Hepatology and Liver Intensive Care Unit, Hospital Beaujon, APHP, Clichy, France.'}, {'ForeName': 'Frank Erhard', 'Initials': 'FE', 'LastName': 'Uschner', 'Affiliation': 'Department of Internal Medicine I, University of Bonn, Bonn, Germany; Department of Internal Medicine I, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'de Wit', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Amsterdam, Academic Medical Center, University of Amsterdam, Netherlands.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Zaccherini', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Alessandria', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angeli', 'Affiliation': 'Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bernardi', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beuers', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Amsterdam, Academic Medical Center, University of Amsterdam, Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caraceni', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Durand', 'Affiliation': 'Hepatology and Liver Intensive Care Unit, Hospital Beaujon, APHP, Clichy, France.'}, {'ForeName': 'Rajeshwar P', 'Initials': 'RP', 'LastName': 'Mookerjee', 'Affiliation': 'Institute of Liver and Digestive Health, University College London, London, UK.'}, {'ForeName': 'Jonel', 'Initials': 'J', 'LastName': 'Trebicka', 'Affiliation': 'Department of Internal Medicine I, University of Bonn, Bonn, Germany; Department of Internal Medicine I, Goethe University Frankfurt, Frankfurt, Germany; European Foundation for the Study of Chronic Liver Failure, Barcelona, Spain; Institute for Bioengineering of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron and Vall d'Hebron Research Unit (VHIR), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Raúl J', 'Initials': 'RJ', 'LastName': 'Andrade', 'Affiliation': 'Unidad de Gestión Clínica de Enfermedades Digestivas, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, CIBERehd, Málaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Carol', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Pich', 'Affiliation': 'Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ferrero', 'Affiliation': 'European Clinical Research Infrastructure Network, Paris, France.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': ""Biostatistics and Data Management Core Facility, Institut D'Investigacions Biomédiques August Pi i Sunyer, Hospital Clinic Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': ""Biostatistics and Data Management Core Facility, Institut D'Investigacions Biomédiques August Pi i Sunyer, Hospital Clinic Barcelona, Spain.""}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Juan G', 'Initials': 'JG', 'LastName': 'Abraldes', 'Affiliation': 'Cirrhosis Care Clinic, Division of Gastroenterology (Liver Unit), University of Alberta, CEGIIR, Edmonton, AB, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Solà', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Ginès', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain. Electronic address: pgines@clinic.cat.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30320-6']
1056,31575640,Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial.,"OBJECTIVE


We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 ± 2.3 years, HbA 1c  7.5 ± 0.5% [58.5 ± 5.5 mmol/mol]) underwent two 27-h inpatient periods with unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals. We compared Faster-CL and Standard-CL in random order. During both interventions, the fuzzy-logic control algorithm DreaMed GlucoSitter was used. Glucose sensor data were analyzed by intention-to-treat principle with the difference (between Faster-CL and Standard-CL) in proportion of time in range 70-180 mg/dL (TIR) over 27 h as the primary end point.
RESULTS


The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL ( P  = 0.170). The proportion of time in hypoglycemia <70 mg/dL was 0.0% for both groups. Baseline-adjusted interstitial prandial glucose increments 1 h after meals were greater in Faster-CL compared with Standard-CL ( P  = 0.017). The gaps between measured plasma insulin and estimated insulin-on-board levels at the beginning, at the end, and 2 h after the exercise were smaller in the Standard-CL group ( P  = 0.029,  P  = 0.003, and  P  = 0.004, respectively). No severe adverse events occurred.
CONCLUSIONS


Fully closed-loop insulin delivery using either faster or standard insulin aspart was safe and efficient in achieving near-normal glucose concentrations outside postprandial periods. The closed-loop algorithm was better adjusted to the standard insulin aspart.",2020,The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL arm ( P  = 0.170).,"['Type 1 Diabetes', '20 participants with type 1 diabetes on insulin pump therapy (11 females; aged 21.3 ± 2.3 years; HbA 1c  7.5 ± 0.5% [58.5 ± 5.5 mmol/mol]) underwent two 27-h inpatient periods with', 'young adults with type 1 diabetes']","['Faster-CL and Standard-CL', 'day-and-night fully closed-loop insulin therapy using faster (Faster-CL', 'Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy', 'standard insulin aspart (Standard-CL', 'unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals']","['severe adverse events', 'proportion of time in hypoglycemia', 'Glucose sensor data', 'Baseline-adjusted interstitial prandial glucose increments 1 h after meals', 'proportion of TIR', 'plasma insulin and estimated insulin-on-board levels', 'safety and efficacy']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0585022', 'cui_str': 'During day (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.170934,The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL arm ( P  = 0.170).,"[{'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Piona', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University City Hospital, Verona, Italy.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Yeşiltepe Mutlu', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Bratina', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jenko Bizjan', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Dusanka', 'Initials': 'D', 'LastName': 'Lepej', 'Affiliation': ""Department of Pulmonology, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Atlas', 'Affiliation': 'DreaMed Diabetes Ltd., Petah Tikva, Israel.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': 'DreaMed Diabetes Ltd., Petah Tikva, Israel.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia tadej.battelino@mf.uni-lj.si.""}]",Diabetes care,['10.2337/dc19-0895']
1057,31886591,Effect of a pharmacist-led intervention on adherence among patients with a first-time prescription for a cardiovascular medicine: a randomized controlled trial in Norwegian pharmacies.,"OBJECTIVE


To examine whether a pharmacist-led intervention improves medication adherence among patients who have filled a first-time prescription for a cardiovascular medicine.
METHODS


Design: Unblinded randomized controlled trial.
SETTING


67 Norwegian pharmacies, October 2014-June 2015.
PARTICIPANTS


1480 adults with a first-time prescription for a cardiovascular medicine.
INTERVENTION


Participants in the intervention group received two consultations with a pharmacist 1-2 and 3-5 weeks after filling the prescription. Participants in the control group received care according to usual practice.
MAIN OUTCOME MEASURE


The primary outcome was self-reported adherence as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8), at 7 and 18 weeks after filling the prescription. Adherence from baseline to week 52 was estimated using data from the Norwegian Prescription Database (NPD).
KEY FINDINGS


Data from MMAS-8 showed that 91.3% of the patients in the intervention group were adherent after 7 weeks versus 86.8% in the control group (4.5% difference, 95% CI 0.8-8.2, P = 0.017). The corresponding proportions were 88.7% versus 83.7% after 18 weeks (5.0% difference, 95% CI 0.8-9.2, P = 0.021). NPD data (n = 1294) showed no significant difference in adherence after 52 weeks (95% CI -2.0 to 7.8, P = 0.24). However, adherence among statin users (n = 182) was 66.5% in the intervention group versus 57.4% among new statin users in the general population (n = 1500) (difference 9.1%, 95% CI 1.5-16.0, P = 0.019).
CONCLUSION


The main outcome measure indicates that a short, structured pharmacist-led intervention may increase medication adherence for patients starting on chronic cardiovascular medication. However, these findings could not be confirmed by the NPD data analysis.",2020,"(difference 9.1%, 95% CI 1.5-16.0, P = 0.019).
","['Design', '67 Norwegian pharmacies, October 2014-June 2015', 'patients who have filled a first-time prescription for a cardiovascular medicine', 'patients with a first-time prescription for a cardiovascular medicine', '1480 adults with a first-time prescription for a cardiovascular medicine']","['pharmacist-led intervention', 'care according to usual practice']","['adherence', 'medication adherence', 'self-reported adherence as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8']","[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}]",1480.0,0.216021,"(difference 9.1%, 95% CI 1.5-16.0, P = 0.019).
","[{'ForeName': 'Ragnar', 'Initials': 'R', 'LastName': 'Hovland', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bremer', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frigaard', 'Affiliation': 'Apokus, National Centre for Development of Pharmacy Practice, Oslo, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Henjum', 'Affiliation': 'Norwegian Pharmacy Association, Oslo, Norway.'}, {'ForeName': 'Per Kristian', 'Initials': 'PK', 'LastName': 'Faksvåg', 'Affiliation': 'Norwegian Pharmacy Association, Oslo, Norway.'}, {'ForeName': 'Erik Magnus', 'Initials': 'EM', 'LastName': 'Saether', 'Affiliation': 'Oslo Economics, Oslo, Norway.'}, {'ForeName': 'Ivar Sønbø', 'Initials': 'IS', 'LastName': 'Kristiansen', 'Affiliation': 'Oslo Economics, Oslo, Norway.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12598']
1058,31347165,A Khorasan wheat-based diet improves systemic inflammatory profile in semi-professional basketball players: a randomized crossover pilot study.,"BACKGROUND/OBJECTIVES


Khorasan wheat is an ancient grain with widely acclaimed beneficial effects on human health. The objective of the study was to examine the effect of a Khorasan-based diet on the wellbeing and inflammatory profile of young athletes.
RESULTS


We conducted a randomized, single-blinded crossover trial involving 20 male young athletes. The participants were randomly assigned to consume products (pasta, bread, biscuits and crackers) made either with Khorasan (KAMUT® brand) or modern semi-whole-grain wheat for 4-weeks with a 4-week washout period before the crossover. Laboratory analyses and fitness tests were performed both at the beginning and end of each diet period. The consumption of Khorasan products was associated with a significant reduction of monocyte chemoattractant protein-1 (MCP-1; mean reduction: -36.15 pg/mL; -25.67%) while the consumption of modern wheat was not associated with significant differences in Interleukin-8 (IL-8) or Interleukin-1 receptor antagonist (IL-1ra). The consumption of the Khorasan-based diet also resulted in a significant improvement in self-rated health status. No statistically significant differences in any athletic performance parameter were observed between the two diets.
CONCLUSION


The present results suggest that a Khorasan-based diet could be effective in reducing the inflammatory status in young athletes. © 2019 Society of Chemical Industry.",2020,while the consumption of modern wheat was not associated with significant differences in Interleukin-8 (IL-8) or Interleukin-1 receptor antagonist (IL-1ra).,"['semi-professional basketball players', 'young athletes', '20 male young athletes']","['Khorasan-based diet', 'Khorasan wheat-based diet', 'consume products (pasta, bread, biscuits and crackers) made either with Khorasan (KAMUT® brand) or modern semi-whole-grain wheat']","['athletic performance parameter', 'monocyte chemoattractant protein-1', 'Interleukin-8 (IL-8) or Interleukin-1 receptor antagonist (IL-1ra', 'self-rated health status', 'inflammatory status', 'systemic inflammatory profile']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3853226', 'cui_str': 'Khorasan wheat (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0452505', 'cui_str': 'Cracker (substance)'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",20.0,0.0585045,while the consumption of modern wheat was not associated with significant differences in Interleukin-8 (IL-8) or Interleukin-1 receptor antagonist (IL-1ra).,"[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Spisni', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Valerii', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'De Fazio', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Rotondo', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Di Natale', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Giovanardi', 'Affiliation': 'Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Posabella', 'Affiliation': 'BioSportMed, Bologna, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Bregola', 'Affiliation': 'Department of Agricultural Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Stenico', 'Affiliation': 'Department of Agricultural Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Rocco Enrico', 'Initials': 'RE', 'LastName': 'Sferrazza', 'Affiliation': 'Department of Agricultural Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Dinelli', 'Affiliation': 'Department of Agricultural Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bosi', 'Affiliation': 'Department of Agricultural Sciences, University of Bologna, Bologna, Italy.'}]",Journal of the science of food and agriculture,['10.1002/jsfa.9947']
1059,32023543,Insights for Blood Flow Restriction and Hypoxia in Leg Versus Arm Submaximal Exercise,"PURPOSE


To assess tissue oxygenation, along with metabolic and physiological responses during blood flow restriction (BFR, bilateral vascular occlusion) and systemic hypoxia conditions during submaximal leg- versus arm-cycling exercise.
METHODS


In both legs and arms, 4 randomized sessions were performed (normoxia 400 m, fraction of inspired oxygen [FIO2] 20.9% and normobaric hypoxia 3800 m, FIO2 13.1% [0.1%]; combined with BFR at 0% and 45% of resting pulse elimination pressure). During each session, a single 6-minute steady-state submaximal exercise was performed to measure physiological changes and oxygenation (near-infrared spectroscopy) of the muscle tissue in both the vastus lateralis (legs) and biceps brachii (arms).
RESULTS


Total hemoglobin concentration ([tHb]) was 65% higher (P < .001) in arms versus legs, suggesting that arms had a greater blood perfusion capacity than legs. Furthermore, there were greater changes in tissue blood volume [tHb] during BFR compared with control conditions (P = .017, F = 5.45). The arms elicited 7% lower tissue saturation (P < .001) and were thus more sensitive to the hypoxia-induced reduction in oxygen supply than legs, no matter the condition. This indicates that legs and arms may elicit different regulatory hemodynamic mechanisms (ie, greater blood flow in arms) for limiting the decreased oxygen delivery during exercise with altered arterial oxygen content.
CONCLUSIONS


The combination of BFR and/or hypoxia led to increased [tHb] in both limbs likely due to greater vascular resistance; further, arms were more responsive than legs. This possibly influences the maintenance of oxygen delivery and enhances perfusion pressure, suggesting greater vascular reactivity in arms than in legs.",2020,"The arms elicited 7% lower tissue saturation (P < .001) and were thus more sensitive to the hypoxia-induced reduction in oxygen supply than legs, no matter the condition.",[],['submaximal leg- versus arm-cycling exercise'],"['normoxia 400\xa0m, fraction of inspired oxygen [FIO2', 'Total hemoglobin concentration ([tHb', 'blood flow restriction (BFR, bilateral vascular occlusion) and systemic hypoxia conditions', 'blood perfusion capacity', 'tissue saturation', 'tissue blood volume']",[],"[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}]",,0.0600787,"The arms elicited 7% lower tissue saturation (P < .001) and were thus more sensitive to the hypoxia-induced reduction in oxygen supply than legs, no matter the condition.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Willis', 'Affiliation': ''}, {'ForeName': 'Grégoire P', 'Initials': 'GP', 'LastName': 'Millet', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Borrani', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0168']
1060,31810744,Sex Differences in Vasovagal Syncope: A Post Hoc Analysis of the Prevention of Syncope Trials (POST) I and II.,"BACKGROUND


Vasovagal syncope (VVS) occurs in > 40% of individuals at least once in their lifetime. Sex-dependent differences in presentation and outcomes are not understood. We sought to determine differences in clinical presentation, treatment modalities, and outcomes of VVS between men and women.
METHODS


Data were collected as part of the Prevention of Syncope Trials (POST) I and II, 2 multicenter, placebo-controlled, randomized trials testing the effectiveness of metoprolol and fludrocortisone, respectively. Data regarding clinical presentation, outcomes, and time to first syncope event after randomization were compared.
RESULTS


Of the 418 patients (280 women and 138 men), women were younger at the time of first syncope event (21 vs 26 years P = 0.002) and had a lower baseline systolic blood pressure (117 vs 124 mm Hg, P < 0.001). Response to heat as a trigger for syncope was more common in women (68% vs 48%, P = 0.011). Clinical presentation in women consisted more commonly of feeling warm, having seizures, and experiencing more postsyncope fatigue (68% vs 54%, P = 0.048; 10% vs 2.7%, P = 0.045; 75% vs 59%, P = 0.017, respectively). Women were more likely to experience recurrent syncope after adjustment for prerandomization syncope burden and randomization assignment (hazard ratio, 1.56; 95% confidence interval, 1.10-2.22; P = 0.012).
CONCLUSION


Clinical presentation and provocative factors of VVS differ between men and women, as do recurrent events. Recognition of these differences may help target therapy specifically in men and women.",2020,"Response to heat as a trigger for syncope was more common in women (68% vs 48%, P = 0.011).","['418 patients (280 women and 138 men', 'men and women', 'Data were collected as part of the Prevention of Syncope Trials (POST']","['placebo', 'metoprolol and fludrocortisone']","['time of first syncope event', 'experience recurrent syncope', 'postsyncope fatigue', 'Vasovagal Syncope', 'Syncope Trials (POST', 'baseline systolic blood pressure', 'time to first syncope event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0016280', 'cui_str': 'Fludrocortisone'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",280.0,0.348786,"Response to heat as a trigger for syncope was more common in women (68% vs 48%, P = 0.011).","[{'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Deveau', 'Affiliation': 'Dalhousie University Medical School, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sheldon', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Maxey', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. Electronic address: Ratika.Parkash@nshealth.ca.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2019.10.008']
1061,31587813,"Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study.","PURPOSE


The prevalence of gestational diabetes mellitus (GDM) is increasing, and multifaceted interventions are effective in the management of GDM. This study aimed to develop and evaluate a model for the management of GDM with the use of mobile health care.
METHODS


This was a prospective, randomized controlled pilot study. A total of 21 patients who were diagnosed with GDM during 24-28 weeks of gestation were randomly divided into a conventional management (CM) group (n = 10) and a mobile management (MM) group (n = 11). The CM group received conventional GDM management and could freely use the mobile health care application. The MM group received mobile health care services, including tailored mobile coaching. After delivery, obstetric outcomes were collected, and 75-g oral glucose tolerance test was performed at 5-12 weeks postpartum.
FINDINGS


Baseline characteristics, including glycosylated hemoglobin (HbA 1c ), were not significantly different between the 2 groups. No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery. No significant difference was found in HbA 1c  between the 2 groups after delivery. However, postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat were significantly lower in the MM group.
IMPLICATIONS


The MM group had no significant difference in glycemic index compared with the CM group. However, the MM group had effective weight control and improved insulin resistance after delivery. This study indicated that mobile health care services could be an efficient GDM management tool. ClinicalTrials.gov identifier: NCT03838380.",2019,No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery.,"['21 patients who were diagnosed with GDM during 24-28 weeks of gestation', 'gestational diabetes mellitus (GDM', 'Gestational Diabetes Using a Digital Health Care Service']","['mobile health care services, including tailored mobile coaching', 'conventional management (CM) group (n\xa0=\xa010) and a mobile management (MM', 'conventional GDM management']","['glycemic index', 'neonate large for gestational age and (2) cesarean section', 'postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat', 'effective weight control and improved insulin resistance', 'HbA 1c', '75-g oral glucose tolerance test', 'glycosylated hemoglobin (HbA 1c ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0465857,No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery.,"[{'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc., Sinsa-dong, Gangnam-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: cydoctor@chol.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.005']
1062,31604403,Cardiac reinnervation affects cardiorespiratory adaptations to exercise training in individuals with heart transplantation.,"PURPOSE


The purpose of this study was to investigate the hemodynamic and cardiorespiratory adaptations to exercise in individuals with heart transplantation with evidence of cardiac reinnervation (cardiac reinnervation group) versus without evidence of cardiac reinnervation (no cardiac reinnervation group).
METHODS


Sedentary individuals with heart transplantation (age = 45.5 ± 2.2 years; time elapsed since surgery = 6.7 ± 0.7 years) were divided into the cardiac reinnervation ( n  = 16) and no cardiac reinnervation ( n  = 17) groups according to their heart rate response to cardiopulmonary exercise testing. The 24-hour ambulatory blood pressure, carotid-femoral pulse wave velocity, and cardiorespiratory fitness were assessed before and after 12 weeks of a thrice-weekly exercise program (five minutes of warm-up, 30 min of endurance exercise, one set of 10-15 reps in five resistance exercises, and five minutes of cool-down).
RESULTS


The cardiac reinnervation group had reduced ( p  < 0.01) 24-hour systolic/diastolic blood pressure (7/9 mm Hg), daytime systolic/diastolic blood pressure (9/10 mm Hg) and nighttime diastolic blood pressure (6 mm Hg) after training. The no cardiac reinnervation group reduced ( p  < 0.05) only 24-hour (5 mm Hg), daytime (5 mm Hg) and nighttime (6 mm Hg) diastolic blood pressure after training. Hourly analysis showed that the cardiac reinnervation group reduced systolic/diastolic blood pressure for 10/21 h, while the no cardiac reinnervation group reduced systolic/diastolic blood pressure for only 3/11 h. The cardiac reinnervation group also improved both maximal oxygen consumption (10.8%) and exercise tolerance (13.4%) after training, but the no cardiac reinnervation group improved only exercise tolerance (9.9%). Pulse wave velocity did not change in both groups.
CONCLUSION


There were greater improvements in ambulatory blood pressure and maximal oxygen consumption in the cardiac reinnervation than the no cardiac reinnervation group. These results suggest that cardiac reinnervation associates with hemodynamic and cardiorespiratory adaptations to exercise training in individuals with heart transplantation.",2020,There were greater improvements in ambulatory blood pressure and maximal oxygen consumption in the cardiac reinnervation than the no cardiac reinnervation group.,"['Sedentary individuals with heart transplantation (age\u2009=\u200945.5\u2009±\u20092.2 years; time elapsed since surgery =\u20096.7\u2009±\u20090.7 years', 'individuals with heart transplantation with evidence of cardiac reinnervation (cardiac reinnervation group) versus without evidence of cardiac reinnervation (no cardiac reinnervation group', 'individuals with heart transplantation']","['cardiac reinnervation ( n \u2009=\u200916) and no cardiac reinnervation ( n \u2009=\u200917) groups according to their heart rate response to cardiopulmonary exercise testing', 'exercise program (five minutes of warm-up, 30\u2009min of endurance exercise, one set of 10-15 reps in five resistance exercises, and five minutes of cool-down', 'exercise training']","['daytime systolic/diastolic blood pressure', 'systolic/diastolic blood pressure', 'nighttime diastolic blood pressure', '24-hour ambulatory blood pressure, carotid-femoral pulse wave velocity, and cardiorespiratory fitness', 'Pulse wave velocity', 'diastolic blood pressure', '24-hour systolic/diastolic blood pressure', 'ambulatory blood pressure and maximal oxygen consumption', 'maximal oxygen consumption', 'exercise tolerance']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1997337', 'cui_str': 'Speed of heart rate response'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",,0.0197534,There were greater improvements in ambulatory blood pressure and maximal oxygen consumption in the cardiac reinnervation than the no cardiac reinnervation group.,"[{'ForeName': 'Emmanuel G', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': 'School of Sciences, Physical Education Department, Exercise and Chronic Disease Research Laboratory, São Paulo State University - UNESP, Brazil.'}, {'ForeName': 'Rafael E', 'Initials': 'RE', 'LastName': 'Castro', 'Affiliation': 'School of Medicine, Heart Institute, University of São Paulo - USP, Brazil.'}, {'ForeName': 'Isabela R', 'Initials': 'IR', 'LastName': 'Marçal', 'Affiliation': 'School of Sciences, Physical Education Department, Exercise and Chronic Disease Research Laboratory, São Paulo State University - UNESP, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bacal', 'Affiliation': 'School of Medicine, Heart Institute, University of São Paulo - USP, Brazil.'}, {'ForeName': 'Edimar A', 'Initials': 'EA', 'LastName': 'Bocchi', 'Affiliation': 'School of Medicine, Heart Institute, University of São Paulo - USP, Brazil.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Guimarães', 'Affiliation': 'School of Medicine, Heart Institute, University of São Paulo - USP, Brazil.'}]",European journal of preventive cardiology,['10.1177/2047487319880650']
1063,31774400,Medical Students' Experiences and Outcomes Using a Virtual Human Simulation to Improve Communication Skills: Mixed Methods Study.,"BACKGROUND


Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)-based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial.
OBJECTIVE


This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication.
METHODS


We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures-MPathic-VR-calculated scores and the objective structured clinical exam (OSCE) scores-with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis.
RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers.
CONCLUSIONS


VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.",2019,"RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01).",['Students at 3 medical schools in the United States (n=206) received'],"['virtual human (VH)-based simulation, MPathic-VR', 'VH-based simulation', 'simulation to improve empathic communication skills', 'Virtual Human Simulation']",['OSCE scores'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.104251,"RESULTS


OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F 1,414 =6.09; P=.01).","[{'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Guetterman', 'Affiliation': 'Creighton University, Omaha, NE, United States.'}, {'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Sakakibara', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srikar', 'Initials': 'S', 'LastName': 'Baireddy', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Kron', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Scerbo', 'Affiliation': 'Old Dominion University, Norfolk, VA, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cleary', 'Affiliation': 'Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Fetters', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}]",Journal of medical Internet research,['10.2196/15459']
1064,29654506,Evaluating the Training of Chinese-Speaking Community Health Workers to Implement a Small-Group Intervention Promoting Mammography.,"This study evaluated the training of Chinese American Community Health Workers (CHWs) to implement a small-group mammography video and discussion program as part of a randomized controlled trial that had the goal to increase adherence to mammography screening guidelines among Chinese American women. A total of 26 Chinese American CHWs in the metropolitan Washington DC area, Southern California, and New York City participated in a 4-h training workshop and completed surveys before and after the workshop to assess their knowledge regarding mammography screening guidelines and human subjects protection rules. The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training. CHWs were also trained to lead a discussion of the video, including screening benefits and misconceptions. Forty-three audio recordings of discussions led by 13 active CHWs were transcribed and qualitatively analyzed to assess implementation fidelity. Ten out of 13 active CHWs fully addressed about 3 of the 5 benefit items, and 11 out of 13 CHWs fully addressed more than 5 of the 9 misconception items. Chinese CHWs can be trained to implement research-based intervention programs. However, a one-time training resulted in moderate adherence to the discussion protocol. Ongoing or repeat trainings throughout the intervention period may be needed to enhance implementation fidelity.",2019,The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training.,"['Chinese American women', 'Chinese American Community Health Workers (CHWs', '26 Chinese American CHWs in the metropolitan Washington DC area, Southern California, and New York City']",['small-group mammography video and discussion program'],"['moderate adherence', 'knowledge of mammography screening guidelines and human subjects protection rules']","[{'cui': 'C0008121', 'cui_str': 'Chinese Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]",43.0,0.0191563,The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training.,"[{'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Maxwell', 'Affiliation': 'Fielding School of Public Health and Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Xiaokun', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Hsing-Chuan', 'Initials': 'HC', 'LastName': 'Hsieh', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA.'}, {'ForeName': 'Shin-Ping', 'Initials': 'SP', 'LastName': 'Tu', 'Affiliation': 'Division of General Internal Medicine, Geriatrics, and Bioethics, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Judy Huei-Yu', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington D.C., USA. jw235@georgetown.edu.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1361-5']
1065,31444917,"Effects of poloxamer-based thermo-sensitive sol-gel agent on urethral stricture after transurethral resection of the prostate for benign prostatic hyperplasia: a multicentre, single-blinded, randomised controlled trial.","OBJECTIVE


To evaluate the effectiveness of poloxamer-based thermo-sensitive sol-gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture.
PATIENTS AND METHODS


In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer-based thermo-sensitive sol-gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer-based thermo-sensitive sol-gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), maximum urinary flow rate (Q max  ), post-void residual urine volume (PVR), and cystoscopy.
RESULTS


Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS-QoL and OAB-q between the groups. However, Q max  was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023).
CONCLUSIONS


Poloxamer-based thermo-sensitive sol-gel instillation after TURP lowered the incidence of urethral stricture.",2020,There were no significant differences in IPSS-QoL and OAB-q between groups.,"['urethral stricture after transurethral resections of the prostate for benign prostatic hyperplasia', '198 initial participants, 80 patients in group A and 83 patients in group B had completed the experiment', '198 patients underwent TURP for benign prostatic hyperplasia']","['poloxamer-based thermo-sensitive sol-gel', 'lubricant instillation after TURP', 'poloxamer-based thermo-sensitive sol-gel instillation', 'poloxamer-based thermo-sensitive sol-gel instillation after transurethral resection of the prostate (TURP']","['International Prostate Symptom Score (IPSS)-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), peak urine flow rate (Qmax), postvoid residual volume (PVR), and cystoscopy', 'IPSS-QoL and OAB-q', 'cystoscopic examination, urethral stricture after TURP', 'incidence of urethral stricture']","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0086827', 'cui_str': 'Poloxamers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",198.0,0.0269043,There were no significant differences in IPSS-QoL and OAB-q between groups.,"[{'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyu Shik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Duck', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Eulji Medical Center, Eulji University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Tae Hyo', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Departments of Urology, College of Medicine, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ki Soo', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Departments of Urology, College of Medicine, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Cheol Young', 'Initials': 'CY', 'LastName': 'Oh', 'Affiliation': 'Department of Urology, Hallym University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon Hwa', 'Initials': 'JH', 'LastName': 'Noh', 'Affiliation': 'Department of Urology, Kwangju Christian Hospital, Gwangju, South Korea.'}, {'ForeName': 'Jun Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Kwangju Christian Hospital, Gwangju, South Korea.'}, {'ForeName': 'Won Tae', 'Initials': 'WT', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, Chungbuk National University, Cheongju, South Korea.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Tae Nam', 'Initials': 'TN', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Huh', 'Affiliation': 'Daewoong Pharmaceutical Co. Ltd, Seoul, South Korea.'}, {'ForeName': 'Seung Wook', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, South Korea.'}]",BJU international,['10.1111/bju.14902']
1066,31585740,Oleuropein-enriched chocolate by extra virgin olive oil blunts hyperglycaemia in diabetic patients: Results from a one-time 2-hour post-prandial cross over study.,"BACKGROUND & AIMS


Oleuropein, a component of extra virgin olive oil (EVOO), reduces post-prandial glycemia with a mechanism counteracting oxidative stress-mediated incretin down-regulation. In this study we evaluated if the intake of an oleuropein-enriched chocolate could have positive effects on glycaemia and insulin levels in patients with type 2 diabetes mellitus (T2DM) and healthy subjects (HS).
METHODS


Twenty-five consecutive T2DM patients and 20 HS were recruited. Participants were randomized to receive 40 g oleuropein-enriched chocolate by EVOO or 40 g control chocolate spread in a cross-over design. Serum glucose, insulin, glucagon-like peptide-1 (GLP1), and dipeptidyl-peptidase-4 (DPP4) were measured before and 2 h after chocolate intake.
RESULTS


In T2DM, the pairwise comparisons showed that intake of oleuropein-enriched chocolate was associated with a significantly less increase of blood glucose compared to control; GLM analysis showed a significant difference for treatments with respect to glucose (p = 0.04), GLP1 (p < 0.001) and DPP-4 activity (p = 0.01). In HS, the pairwise comparisons showed that, after oleuropein-enriched chocolate intake, blood glucose concentration and DPP4 activity did not change; conversely a significant increase was observed for insulin and GLP1. After control chocolate intake, a significant increase for blood glucose, insulin levels and DPP4 activity were observed while GLP1 did not change.
CONCLUSION


The study shows that using EVOO as source of oleuropein administration of 40 g oleuropein-enriched chocolate is associated with a modest increase or no change of glycemia in T2DM and HS respectively, via an incretin-mediated mechanism.",2020,"After control chocolate intake, a significant increase for blood glucose, insulin levels and DPP4 activity were observed while GLP1 did not change.
","['Twenty-five consecutive T2DM patients and 20 HS were recruited', 'patients with type 2 diabetes mellitus (T2DM) and healthy subjects (HS', 'diabetic patients']","['oleuropein-enriched chocolate', '40\xa0g oleuropein-enriched chocolate by EVOO or 40\xa0g control chocolate spread in a cross-over design', 'oleuropein', 'extra virgin olive oil (EVOO', 'Oleuropein', 'Oleuropein-enriched chocolate by extra virgin olive oil blunts']","['glycaemia and insulin levels', 'insulin and GLP1', 'GLP1', 'blood glucose, insulin levels and DPP4 activity', 'hyperglycaemia', 'DPP-4 activity', 'chocolate intake, blood glucose concentration and DPP4 activity', 'Serum glucose, insulin, glucagon-like peptide-1 (GLP1), and dipeptidyl-peptidase-4 (DPP4', 'blood glucose']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0069413', 'cui_str': 'oleuropein'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0458165', 'cui_str': 'Chocolate spread (substance)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}]",25.0,0.0749383,"After control chocolate intake, a significant increase for blood glucose, insulin levels and DPP4 activity were observed while GLP1 did not change.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Ben', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Nocella', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Loffredo', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bartimoccia', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammisotto', 'Affiliation': 'Department of General Surgery and Surgical Speciality Paride Stefanini, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Mancinella', 'Affiliation': 'ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Angelico', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Valenti', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea, Cardiocentro-Napoli, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavarretta', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea, Cardiocentro-Napoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea, Cardiocentro-Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Violi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy; Mediterranea, Cardiocentro-Napoli, Italy. Electronic address: francesco.violi@uniroma1.it.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.09.006']
1067,28949010,The value of oral micronized progesterone in the prevention of recurrent spontaneous preterm birth: a randomized controlled trial.,"INTRODUCTION


Progesterone is becoming universally accepted for preventing recurrent spontaneous preterm delivery. There is, however, poor consensus on the effective types and doses of progesterone to be used. Despite the encouraging available research, the role of oral micronized progesterone has not yet been thoroughly investigated.
MATERIAL AND METHODS


We randomized 212 singleton pregnancies with past history of spontaneous preterm delivery at <37 weeks, into a progesterone group (receiving 100 mg oral micronized progesterone, six-hourly, starting at 14-18 weeks until 37 weeks or delivery) and an identical placebo group. The rate of spontaneous preterm delivery was the primary outcome. Secondary outcomes included gestational age at birth and admission to neonatal intensive care units.
RESULTS


The progesterone group delivered at a later gestational age, and needed longer tocolysis-to-delivery intervals (35.4 weeks vs. 33.9 weeks, p = 0.01, and 87 days vs. 36 days, p < 0.001, respectively). The relative risk of spontaneous preterm delivery was 0.7 (95% confidence interval 0.54-0.92, p = 0.01), and the number needed-to-treat to prevent one case of spontaneous preterm delivery was 5 (95% confidence interval 3-20). The two groups had similar rates of operative delivery and postpartum complications. Progesterone was associated with mild maternal dizziness (29.1% vs. 9.8%, p = 0.002), somnolence (41.6% vs. 19.7%, p = 0.002), and vaginal dryness (20.8% vs. 8.7%, p = 0.03), lower neonatal mortality rates (7.3% vs. 25.2%, p < 0.001), and shorter neonatal intensive care unit admissions (p = 0.008).
CONCLUSION


Oral micronized progesterone is effective in preventing spontaneous preterm delivery. The additional advantages of oral administration, affordability, and high safety profile make it worth recommending, at least for further research.",2017,"The relative risk of spontaneous preterm delivery was 0.7 (95% confidence interval 0.54-0.92, p = 0.01), and the number needed-to-treat to prevent one case of spontaneous preterm delivery was 5 (95% confidence interval 3-20).","['recurrent spontaneous preterm birth', '212 singleton pregnancies with past history of spontaneous preterm delivery at <37\xa0weeks, into a']","['micronized progesterone', 'placebo', 'progesterone', 'progesterone group (receiving 100\xa0mg oral micronized progesterone', 'Progesterone', 'Oral micronized progesterone']","['vaginal dryness', 'mild maternal dizziness', 'neonatal mortality rates', 'gestational age at birth and admission to neonatal intensive care units', 'rate of spontaneous preterm delivery', 'relative risk of spontaneous preterm delivery', 'rates of operative delivery and postpartum complications', 'shorter neonatal intensive care unit admissions', 'somnolence', 'spontaneous preterm delivery']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",212.0,0.388246,"The relative risk of spontaneous preterm delivery was 0.7 (95% confidence interval 0.54-0.92, p = 0.01), and the number needed-to-treat to prevent one case of spontaneous preterm delivery was 5 (95% confidence interval 3-20).","[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Ashoush', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'El-Kady', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Gehan', 'Initials': 'G', 'LastName': 'Al-Hawwary', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Othman', 'Affiliation': 'Department of Obstetrics and Gynecology, Ghamra Military Hospital, Cairo, Egypt.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13236']
1068,31582542,Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial.,"n the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction therapy was prospectively evaluated in transplant-ineligible patients with multiple myeloma. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. The analysis presented here (median follow-up of 71 months) is focused on maintenance treatment and on subgroup analyses defined according to the International Myeloma Working Group Frailty Score. Of the 654 evaluable patients, 217 were in the lenalidomide-dexamethasone arm, 217 in the melphalan-prednisone-lenalidomide arm and 220 in the cyclophosphamide-prednisone-lenalidomide arm. With regards to the Frailty Score, 284 (43%) patients were fit, 205 (31%) were intermediate-fit and 165 (25%) were frail. After induction, 402 patients were eligible for maintenance therapy (lenalidomide arm, n=204; lenalidomide-prednisone arm, n=198). After a median duration of maintenance of 22.0 months, progression-free survival from the start of maintenance was 22.2 months with lenalidomide-prednisone  vs  18.6 months with lenalidomide (hazard ratio 0.85,  P =0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients;  P =0.001). Grade ≥3 non-hematologic adverse events were rare (<15%). In fit patients, melphalan-prednisone-lenalidomide significantly prolonged progression-free survival compared to cyclophosphamide-prednisone-lenalidomide (hazard ratio 0.72,  P =0.05) and lenalidomide-dexamethasone (hazard ratio 0.72,  P =0.04). Likewise, a trend towards a better overall survival was noted for patients treated with melphalan-prednisone-lenalidomide or cyclophosphamide-prednisone-lenalidomide, as compared to lenalidomide-dexamethasone. No differences were observed in intermediate-fit and frail patients. This analysis showed positive outcomes of maintenance with lenalidomide-based regimens, with a good safety profile. For the first time, we showed that fit patients benefit from a full-dose triplet regimen, while intermediate-fit and frail patients benefit from gentler regimens. ClinicalTrials.gov registration number: NCT01093196.",2020,Grade ≥3 non-hematologic adverse events were rare (<15%).,"['transplant-ineligible multiple myeloma patients', 'elderly newly diagnosed multiple myeloma patients', '217 patients in', '284', '402 patients were eligible for maintenance, (lenalidomide arm: 204']","['cyclophosphamide-prednisone-lenalidomide (HR 0.72,p=0.05) and lenalidomide-dexamethasone', 'lenalidomide-dexamethasone', 'Lenalidomide-based induction and maintenance', 'lenalidomide-prednisone', 'lenalidomide-dexamethasone, 217 in melphalan-prednisone-lenalidomide and 220 in cyclophosphamide-prednisone-lenalidomide', 'lenalidomide alone or with prednisone continuously', 'alkylator (melphalan or cyclophosphamide', 'melphalan-prednisone-lenalidomide', 'melphalan-prednisone-lenalidomide and cyclophosphamide-prednisone-lenalidomide']","['progression-free survival', 'prolonged progression-free survival', 'Grade ≥3 non-hematologic adverse events', 'overall survival', 'neutropenia']","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",402.0,0.100541,Grade ≥3 non-hematologic adverse events were rare (<15%).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy sarabringhen@yahoo.com.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': ""D'Agostino"", 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paris', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': ""Sezione di Ematologia e Immunologia Clinica, Ospedale Santa Maria della Misericordia, località Sant'Andrea delle Fratte, Perugia, Italy.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pescosta', 'Affiliation': 'Reparto Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Spada', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pezzatti', 'Affiliation': 'Divisione di Ematologia, Ospedale S. Gerardo, Monza, Italy.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Azienda Ospedaliera S. Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Rota-Scalabrini', 'Affiliation': 'Medical Oncology, Candiolo Cancer Institute FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'De Rosa', 'Affiliation': 'Hematology and Stem Cell Transplantation Unit, Az. Osp. S. Camillo-Forlanini, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pavone', 'Affiliation': 'UOC Ematologia e Trapianto, Az. Osp. C. Panico, Tricase (Lecce), Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Gazzera', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Poggiu', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Istituto Clinico Humanitas, Humanitas University, Rozzano-Milano, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Gentile', 'Affiliation': 'UOC Ematologia AO Cosenza, Cosenza, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baldini', 'Affiliation': 'UOC Ematologia, Università degli Studi di Milano, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Azienda Policlinico Umberto I, Roma, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Tosi', 'Affiliation': 'UO Ematologia, Ospedale di Rimini, AUSL della Romagna, Rimini, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Marasca', 'Affiliation': 'Hematology Unit, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cellini', 'Affiliation': 'U.O. Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Falco', 'Affiliation': 'SSD Ematologia, ASLTO4, Ospedali di Chivasso Cirié Ivrea, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}]",Haematologica,['10.3324/haematol.2019.226407']
1069,31437698,Transcranial direct current stimulation for the treatment of generalized anxiety disorder: A randomized clinical trial.,"BACKGROUND


Generalized anxiety disorder (GAD) is a common condition with current treatments being only moderately effective. Non-invasive brain stimulation techniques might provide a novel approach for treating GAD. Transcranial direct current stimulation (tDCS) has shown promising efficacy and tolerability for major depression but has not been investigated for GAD yet. Thus, we investigated the effects of tDCS on patients with GAD.
METHODS


We conducted a pilot, double-blind, randomized, sham-controlled trial on 30 GAD patients. Five sessions of tDCS (2 mA, 20 min, anode over the left dorsolateral prefrontal cortex and cathode over the right supraorbital cortex) were performed. Anxiety was the primary outcome and it was measured by the Hamilton Anxiety Rating Scale and the Beck Anxiety Inventory. Secondary outcomes were accessed by the Lipp Inventory of Stress Symptoms for Adults, Positive and Negative Affect Schedule, and the Beck Depression Inventory (BDI). Data were examined at baseline, after the 5th day of intervention, and at 1-week follow-up.
RESULTS


Thirty patients finished the study. There were no significant improvements in anxiety, mood symptoms of stress, affectivity or depression. Anodal stimulation of the left DLPFC showed significant improvements in physical symptoms of stress in GAD patients.
LIMITATIONS


Additional tDCS sessions could have resulted in larger tDCS effects.
CONCLUSION


Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved. The role of tDCS in GAD should be explored in larger patient samples using different parameters.",2019,"Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved.","['generalized anxiety disorder', 'GAD patients', 'patients with GAD', 'Thirty patients finished the study', '30 GAD patients']","['tDCS', 'Transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS']","['Hamilton Anxiety Rating Scale and the Beck Anxiety Inventory', 'anxiety, mood symptoms of stress, affectivity or depression', 'Anxiety', 'Lipp Inventory of Stress Symptoms for Adults, Positive and Negative Affect Schedule, and the Beck Depression Inventory (BDI', 'physical symptoms of stress']","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",30.0,0.0858686,"Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved.","[{'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'de Lima', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Francisco Moisés Azevedo', 'Initials': 'FMA', 'LastName': 'Braga', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo Maciel Medeiros', 'Initials': 'RMM', 'LastName': 'da Costa', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Elihab Pereira', 'Initials': 'EP', 'LastName': 'Gomes', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'André Russowsky', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Department of Internal Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil. Electronic address: rodrigopegado@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.020']
1070,31540791,"Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND


Localised prostate cancer is commonly treated with external-beam radiotherapy. Moderate hypofractionation has been shown to be non-inferior to conventional fractionation. Ultra-hypofractionated stereotactic body radiotherapy would allow shorter treatment courses but could increase acute toxicity compared with conventionally fractionated or moderately hypofractionated radiotherapy. We report the acute toxicity findings from a randomised trial of standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy for low-risk to intermediate-risk localised prostate cancer.
METHODS


PACE is an international, phase 3, open-label, randomised, non-inferiority trial. In PACE-B, eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4 + 3 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada). Participants were randomly allocated (1:1) by computerised central randomisation with permuted blocks (size four and six), stratified by centre and risk group, to conventionally fractionated or moderately hypofractionated radiotherapy (78 Gy in 39 fractions over 7·8 weeks or 62 Gy in 20 fractions over 4 weeks, respectively) or stereotactic body radiotherapy (36·25 Gy in five fractions over 1-2 weeks). Neither participants nor investigators were masked to allocation. Androgen deprivation was not permitted. The primary endpoint of PACE-B is freedom from biochemical or clinical failure. The coprimary outcomes for this acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score up to 12 weeks after radiotherapy. Analysis was per protocol. This study is registered with ClinicalTrials.gov, NCT01584258. PACE-B recruitment is complete and follow-up is ongoing.
FINDINGS


Between Aug 7, 2012, and Jan 4, 2018, we randomly assigned 874 men to conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy (n=433). 432 (98%) of 441 patients allocated to conventionally fractionated or moderately hypofractionated radiotherapy and 415 (96%) of 433 patients allocated to stereotactic body radiotherapy received at least one fraction of allocated treatment. Worst acute RTOG gastrointestinal toxic effect proportions were as follows: grade 2 or more severe toxic events in 53 (12%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 43 (10%) of 415 patients in the stereotactic body radiotherapy group (difference -1·9 percentage points, 95% CI -6·2 to 2·4; p=0·38). Worst acute RTOG genitourinary toxicity proportions were as follows: grade 2 or worse toxicity in 118 (27%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 96 (23%) of 415 patients in the stereotactic body radiotherapy group (difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16). No treatment-related deaths occurred.
INTERPRETATION


Previous evidence (from the HYPO-RT-PC trial) suggested higher patient-reported toxicity with ultrahypofractionation. By contrast, our results suggest that substantially shortening treatment courses with stereotactic body radiotherapy does not increase either gastrointestinal or genitourinary acute toxicity.
FUNDING


Accuray and National Institute of Health Research.",2019,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","['eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4\u2008+\u20083 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada', '874 men to', '432 (98%) of 441 patients allocated to', 'Between Aug 7, 2012, and Jan 4, 2018', '433 patients allocated to']","['hypofractionated radiotherapy', 'stereotactic body radiotherapy', 'Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy', 'Ultra-hypofractionated stereotactic body radiotherapy', 'standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy', 'external-beam radiotherapy', 'conventionally fractionated or moderately hypofractionated', 'radiotherapy']","['acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score', 'acute toxicity', 'toxicity', 'Androgen deprivation', 'PACE-B is freedom from biochemical or clinical failure', 'gastrointestinal or genitourinary acute toxicity', 'severe toxic events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",874.0,0.279497,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","[{'ForeName': 'Douglas H', 'Initials': 'DH', 'LastName': 'Brand', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Tree', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ostler', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Voet', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Camilleri', 'Affiliation': 'Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kancherla', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Frew', 'Affiliation': 'Freeman Hospital, Newcastle, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'University Hospitals Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Dayes', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burnett', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Duffton', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hinder', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Morrison', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK. Electronic address: nicholas.vanas@rmh.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30569-8']
1071,28904061,A Randomized Controlled Trial of Green Tea Extract Supplementation and Mammographic Density in Postmenopausal Women at Increased Risk of Breast Cancer.,"Epidemiologic and animal studies suggest a protective role of green tea against breast cancer. However, the underlying mechanism is not understood. We conducted a randomized, double-blinded, placebo-controlled phase II clinical trial to investigate whether supplementation with green tea extract (GTE) modifies mammographic density (MD), as a potential mechanism, involving 1,075 healthy postmenopausal women. Women assigned to the treatment arm consumed daily 4 decaffeinated GTE capsules containing 1,315 mg total catechins, including 843 mg epigallocatechin-3-gallate (EGCG) for 12 months. A computer-assisted method (Madena) was used to assess MD in digital mammograms at baseline and month 12 time points in 932 completers (462 in GTE and 470 in placebo). GTE supplementation for 12 months did not significantly change percent MD (PMD) or absolute MD in all women. In younger women (50-55 years), GTE supplementation significantly reduced PMD by 4.40% as compared with the placebo with a 1.02% PMD increase from pre- to postintervention ( P  = 0.05), but had no effect in older women ( P interaction  = 0.07). GTE supplementation did not induce MD change in other subgroups of women stratified by catechol- O -methyltransferase genotype or level of body mass index. In conclusion, 1-year supplementation with a high dose of EGCG did not have a significant effect on MD measures in all women, but reduced PMD in younger women, an age-dependent effect similar to those of tamoxifen. Further investigation of the potential chemopreventive effect of green tea intake on breast cancer risk in younger women is warranted.  Cancer Prev Res; 10(12); 710-8. ©2017 AACR .",2017,GTE supplementation did not induce MD change in other subgroups of women stratified by catechol- O -methyltransferase genotype or level of body mass index.,"['1,075 healthy postmenopausal women', 'Postmenopausal Women at Increased Risk of Breast Cancer', 'younger women']","['Green Tea Extract Supplementation', 'placebo', 'decaffeinated GTE capsules containing 1,315 mg total catechins, including 843 mg epigallocatechin-3-gallate (EGCG', 'GTE supplementation', 'green tea intake', 'supplementation with green tea extract (GTE) modifies mammographic density (MD', 'tamoxifen', 'EGCG']","['breast cancer risk', 'MD measures', 'PMD', 'change percent MD (PMD) or absolute MD', 'MD change']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1268717', 'cui_str': 'Mammographic Density'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",1075.0,0.615375,GTE supplementation did not induce MD change in other subgroups of women stratified by catechol- O -methyltransferase genotype or level of body mass index.,"[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Samavat', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota.'}, {'ForeName': 'Giske', 'Initials': 'G', 'LastName': 'Ursin', 'Affiliation': 'Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Emory', 'Affiliation': 'Department of Radiology, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Renwei', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Division of Cancer Control and Population Sciences, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Torkelson', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Dostal', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Hepatology, & Nutrition, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Swenson', 'Affiliation': 'Virginia Piper Cancer Institute, Allina Health System, Minneapolis, Minnesota.'}, {'ForeName': 'Chap T', 'Initials': 'CT', 'LastName': 'Le', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Chung S', 'Initials': 'CS', 'LastName': 'Yang', 'Affiliation': 'Department of Chemical Biology, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, New Jersey.'}, {'ForeName': 'Mimi C', 'Initials': 'MC', 'LastName': 'Yu', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Wu', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Yuan', 'Affiliation': 'Division of Cancer Control and Population Sciences, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mindy S', 'Initials': 'MS', 'LastName': 'Kurzer', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota. mkurzer@umn.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-17-0187']
1072,31581789,Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial.,"BACKGROUND


The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure.
METHODS


EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group.
RESULTS


Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation.
CONCLUSIONS


The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.",2019,"The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%).","['peripheral artery disease patients', '2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study', '13\u2009885 patients with symptomatic peripheral artery disease', 'patients with peripheral artery disease', 'for the prevention of major adverse cardiovascular events', 'Peripheral Artery Disease']","['Ticagrelor', 'ticagrelor', 'clopidogrel']","['lower extremity amputation', 'hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding', 'severity of bleeding events', 'Myocardial Infarction major or minor bleeding', 'All bleeding events', 'severity of periprocedural bleeding', 'incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C3160770', 'cui_str': 'Minor bleed'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}]",2661.0,0.0398607,"The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%).","[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine (Z.H., F.W.R., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine (Z.H., F.W.R., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine and Surgery, New York University School of Medicine (J.S.B.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Turku University Hospital, Turku University, Finland (J.I.B.).'}, {'ForeName': 'F Gerry', 'Initials': 'FG', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.F.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, MD (B.K.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Sweden (L.N.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, Division of Cardiology and CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008069']
1073,31582355,"Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND


Chemotherapy for patients with advanced oesophageal squamous cell carcinoma offers poor long-term survival prospects. We report the final analysis from our study of the immune checkpoint PD-1 inhibitor nivolumab versus chemotherapy in patients with previously treated advanced oesophageal squamous cell carcinoma.
METHODS


We did a multicentre, randomised, open-label, phase 3 trial (ATTRACTION-3) at 90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA. We enrolled patients aged 20 years and older with unresectable advanced or recurrent oesophageal squamous cell carcinoma (regardless of PD-L1 expression), at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, a baseline Eastern Cooperative Oncology Group performance status of 0-1, and who were refractory or intolerant to one previous fluoropyrimidine-based and platinum-based chemotherapy and had a life expectancy of at least 3 months. Patients were randomly assigned (1:1) to either nivolumab (240 mg for 30 min every 2 weeks) or investigator's choice of chemotherapy (paclitaxel 100 mg/m 2  for at least 60 min once per week for 6 weeks then 1 week off; or docetaxel 75 mg/m 2  for at least 60 min every 3 weeks), all given intravenously. Treatment continued until disease progression assessed by the investigator per RECIST version 1.1 or unacceptable toxicity. Randomisation was done using an interactive web response system with a block size of four and stratified according to geographical region (Japan vs rest of the world), number of organs with metastases, and PD-L1 expression. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival, defined as the time from randomisation until death from any cause, in the intention-to-treat population that included all randomly assigned patients. Safety was assessed in all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, number NCT02569242, and follow-up for long-term outcomes is ongoing.
FINDINGS


Between Jan 7, 2016, and May 25, 2017, we assigned 419 patients to treatment: 210 to nivolumab and 209 to chemotherapy. At the time of data cutoff on Nov 12, 2018, median follow-up for overall survival was 10·5 months (IQR 4·5-19·0) in the nivolumab group and 8·0 months (4·6-15·2) in the chemotherapy group. At a minimum follow-up time (ie, time from random assignment of the last patient to data cutoff) of 17·6 months, overall survival was significantly improved in the nivolumab group compared with the chemotherapy group (median 10·9 months, 95% CI 9·2-13·3 vs 8·4 months, 7·2-9·9; hazard ratio for death 0·77, 95% CI 0·62-0·96; p=0·019). 38 (18%) of 209 patients in the nivolumab group had grade 3 or 4 treatment-related adverse events compared with 131 (63%) of 208 patients in the chemotherapy group. The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group. Five deaths were deemed treatment-related: two in the nivolumab group (one each of interstitial lung disease and pneumonitis) and three in the chemotherapy group (one each of pneumonia, spinal cord abscess, and interstitial lung disease).
INTERPRETATION


Nivolumab was associated with a significant improvement in overall survivaland a favourable safety profile compared with chemotherapy in previously treated patients with advanced oesophageal squamous cell carcinoma, and might represent a new standard second-line treatment option for these patients.
FUNDING


ONO Pharmaceutical Company and Bristol-Myers Squibb.",2019,The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group.,"['patients with previously treated advanced oesophageal squamous cell carcinoma', '90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA', 'patients with advanced oesophageal squamous cell carcinoma', 'Between Jan 7, 2016, and May 25, 2017, we assigned 419 patients to treatment: 210 to nivolumab and 209 to chemotherapy', 'patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous', 'enrolled patients aged 20 years and older with unresectable advanced or recurrent oesophageal squamous cell carcinoma (regardless of PD-L1 expression), at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors']","['docetaxel', 'Nivolumab versus chemotherapy', 'chemotherapy (paclitaxel', 'chemotherapy', 'fluoropyrimidine-based and platinum-based chemotherapy', 'nivolumab', 'immune checkpoint PD-1 inhibitor nivolumab versus chemotherapy']","['Safety', 'overall survival', 'grade 3 or 4 treatment-related adverse events', 'neutrophil count', 'overall survival, defined as the time from randomisation until death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",419.0,0.302424,The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: kenkato@ncc.go.jp.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Chen-Yuan', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology and Oncology, China Medical University Hospital and School of Pharmacy, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Gastroenterological Chemotherapy Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Internal Medicine, Keio Cancer Center, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Surgery, Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Chueh-Chuan', 'Initials': 'CC', 'LastName': 'Yen', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Oncology, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Xynos', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Kodani', 'Affiliation': 'Department of Oncology, ONO Pharmaceutical Company, Osaka, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30626-6']
1074,31298627,The effect of electrical stimulation on impairment of the painful post-stroke shoulder.,"Background : Transcutaneous electrical nerve stimulation (TENS) and transcutaneous neuromuscular electrical stimulation (t-NMES) are commonly used therapies in the treatment of chronic hemiplegic shoulder pain. These treatments are often utilized during physical or occupational therapy sessions, yet research into the acute analgesic effects of TENS and t-NMES on hemiplegic shoulder pain and use during therapy is limited.  Objective : To compare the acute effects of transcutaneous electrical nerve stimulation (TENS), transcutaneous neuromuscular electrical stimulation (t-NMES), and no stimulation on pain-free passive range of motion of the shoulder in subjects with hemiplegic shoulder pain.  Methods : Prospective cohort study of 10 subjects randomly treated with t-NMES, TENS, and one non-stimulation experimental condition. Pain-free passive external rotation and abduction range of motion of the affected shoulder were measured during stimulation.  Results : There was not a significant within-subject difference in pain-free range of motion for external rotation or abduction. Subject to subject differences explained the majority of the variability in pain-free range of motion.  Conclusion : This pilot study is the first to measure pain-free passive range of motion during electrical stimulation. Our findings demonstrate the lack of an acute effect of TENS and t-NMES on pain reduction.",2019,There was not a significant within-subject difference in pain-free range of motion for external rotation or abduction.,"['subjects with hemiplegic shoulder pain', '10 subjects randomly treated with t-NMES, TENS, and one non-stimulation experimental condition', 'impairment of the painful post-stroke shoulder', 'chronic hemiplegic shoulder pain']","['electrical stimulation', ' ', 'transcutaneous electrical nerve stimulation (TENS), transcutaneous neuromuscular electrical stimulation (t-NMES', 'Transcutaneous electrical nerve stimulation (TENS) and transcutaneous neuromuscular electrical stimulation (t-NMES']","['pain-free range of motion for external rotation or abduction', 'pain reduction', 'hemiplegic shoulder pain', 'Pain-free passive external rotation and abduction range of motion of the affected shoulder']","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",,0.0490817,There was not a significant within-subject difference in pain-free range of motion for external rotation or abduction.,"[{'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Whitehair', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System , Cleveland , OH , USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System , Cleveland , OH , USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Hisel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System , Cleveland , OH , USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Wilson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System , Cleveland , OH , USA.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1633796']
1075,31714033,"Motivated, Fit, and Strong-Using Counter-Stereotypical Images to Reduce Weight Stigma Internalisation in Women with Obesity.","BACKGROUND


This study aimed to use implicit retraining to change automatic associations between body size and physical activity (PA) in women with obesity to reduce weight bias internalisation (WBI).
METHODS


A Solomon-square experimental design was used to determine the effect of a four-week online implicit retraining intervention on WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures). The intervention was a visual probe task pairing counter-stereotypical images of active individuals with obesity with positive PA-related words. In qualitative telephone interviews, a sub-sample of participants provided feedback and recommendations for using counter-stereotypical images in PA promotion.
RESULTS


Women completed the intervention (n = 48) or a control task (n = 55). Results of a RM-ANOVA showed no interaction or main effect of group on WBI. A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up. There were no differences between groups or over time for PA attitudes, self-efficacy, or behaviour. Women who completed interviews (n = 16) discussed several benefits and drawbacks of using counter-stereotypical images.
CONCLUSION


Implicit retraining did not reduce WBI but qualitative findings support the use of counter-stereotypical PA images.",2020,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","['active individuals with obesity with positive PA-related words', 'women with obesity to reduce weight bias internalisation (WBI', 'Women with Obesity']","['Implicit retraining', 'online implicit retraining intervention', 'implicit retraining']","['time for PA attitudes, self-efficacy, or behaviour', 'WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.0307913,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","[{'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Myre', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Berry', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Hussey', 'Affiliation': 'Obesity Canada, Edmonton, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12187']
1076,28124198,Laser-assisted topical corticosteroid delivery for the treatment of keloids.,"Laser-assisted drug delivery has generated intense interest. The objectives of this study are to evaluate the clinical benefit of laser-assisted corticosteroid delivery and to compare this technique to corticosteroid intralesional injection, a standard treatment for keloids. Patients with keloids on the left shoulder after BCG vaccination were enrolled in this study. The entire lesion was first treated with an ablative fractional erbium-YAG laser. After this treatment, the lesion was divided into two halves. The first half received an intralesional injection of corticosteroid, whereas the second half received topical application of corticosteroids that were occluded for 3 hours. Four treatment sessions were conducted, with treatments occurring once every 6 weeks. Treatment outcomes were evaluated using the Vancouver Scar Scale (VSS). Pain was self-assessed by the patient during the procedure. The mean keloid VSS score before treatment was 8.59 ± 1.23 for the corticosteroid injection site and 8.31 ± 2.09 for the topical site. After treatment, the mean keloid VSS score was decreased on both sides (4.56 ± 1.09 vs 5.02 ± 0.87, respectively, P > 0.05). Patients rated their satisfaction level as ""moderate"" on both sides. However, the mean pain score was 1.1 out of 10 on the topical side versus 6.1 on the corticosteroid injection site. The combination of ablative fractional laser treatment and topical corticosteroid application is a promising modality for the treatment of keloids. Moreover, this procedure was not associated with any serious adverse reactions or unbearable pain.",2017,"After treatment, the mean keloid VSS score was decreased on both sides (4.56 ± 1.09 vs 5.02 ± 0.87, respectively, P > 0.05).",['Patients with keloids on the left shoulder after BCG vaccination'],"['ablative fractional erbium-YAG laser', 'intralesional injection of corticosteroid', 'ablative fractional laser treatment and topical corticosteroid application', 'laser-assisted corticosteroid delivery', 'Laser-assisted topical corticosteroid', 'corticosteroid intralesional injection']","['Pain', 'mean keloid VSS score', 'mean pain score', 'serious adverse reactions or unbearable pain', 'Vancouver Scar Scale (VSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium YAG Lasers'}, {'cui': 'C0021490', 'cui_str': 'Injections, Intralesional'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}]",,0.0284107,"After treatment, the mean keloid VSS score was decreased on both sides (4.56 ± 1.09 vs 5.02 ± 0.87, respectively, P > 0.05).","[{'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Chun', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. bell711@hanmail.net.'}]",Lasers in medical science,['10.1007/s10103-017-2154-5']
1077,31557329,Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial.,"OBJECTIVE


The current Phase 2b study aimed to evaluate the efficacy of mindfulness-based cognitive therapy for migraine (MBCT-M) to reduce migraine-related disability in people with migraine.
BACKGROUND


Mindfulness-based interventions represent a promising avenue to investigate effects in people with migraine. MBCT teaches mindfulness meditation and cognitive-behavioral skills and directly applies these skills to address disease-related cognitions.
METHODS


Participants with migraine (6-30 headache days/month) were recruited from neurology office referrals and local and online advertisements in the broader New York City area. During the 30-day baseline period, all participants completed a daily headache diary. Participants who met inclusion and exclusion criteria were randomized in a parallel design, stratified by chronic migraine status, to receive either 8 weekly individual MBCT-M sessions or 8 weeks of waitlist/treatment as usual (WL/TAU). All participants completed surveys including primary outcome evaluations at Months 0, 1, 2, and 4. All participants completed a headache diary during the 30-day posttreatment evaluation period. Primary outcomes were the change from Month 0 to Month 4 in the headache disability inventory (HDI) and the Migraine Disability Assessment (MIDAS) (total score ≥ 21 indicating severe disability); secondary outcomes (headache days/30 days, average headache attack pain intensity, and attack-level migraine-related disability [Migraine Disability Index (MIDI)]) were derived from the daily headache diary.
RESULTS


Sixty participants were randomized to receive MBCT-M (n = 31) or WL/TAU (n = 29). Participants (M age = 40.1, SD = 11.7) were predominantly White (n = 49/60; 81.7%) and Non-Hispanic (N = 50/60; 83.3%) women (n = 55/60; 91.7%) with a graduate degree (n = 35/60; 55.0%) who were working full-time (n = 38/60; 63.3%). At baseline, the average HDI score (51.4, SD = 19.0) indicated a moderate level of disability and the majority of participants (50/60, 83.3%) fell in the ""Severe Disability"" range in the MIDAS. Participants recorded an average of 16.0 (SD = 5.9) headache days/30 days, with an average headache attack pain intensity of 1.7 on a 4-point scale (SD = 0.3), indicating moderate intensity. Average levels of daily disability reported on the MIDI were 3.1/10 (SD = 1.8). For the HDI, mean scores decreased more from Month 0 to Month 4 in the MBCT-M group (-14.3) than the waitlist/treatment as an usual group (-0.2; P < .001). For the MIDAS, the group*month interaction was not significant when accounting for the divided alpha, P = .027; across all participants in both groups, the estimated proportion of participants falling in the ""Severe Disability"" category fell significantly from 88.3% at Month 0 to 66.7% at Month 4, P < .001. For diary-reported headache days/30 days an average headache attack pain intensity, neither the group*month interaction (Ps = .773 and .888, respectively) nor the time effect (Ps = .059 and .428, respectively) was significant. Mean MIDI scores decreased in the MBCT-M group (-0.6/10), whereas they increased in the waitlist/treatment as an usual group (+0.3/10), P = .007.
CONCLUSIONS


MBCT-M demonstrated efficacy to reduce headache-related disability and attack-level migraine-related disability. MBCT-M is a promising emerging treatment for addressing migraine-related disability.",2019,"For the HDI, mean scores decreased more from Month 0 to Month 4 in the MBCT-M group (-14.3) than the waitlist/treatment as an usual group (-0.2; P < .001).","['Sixty participants', 'Participants with migraine (6-30 headache days/month) were recruited from neurology office referrals and local and online advertisements in the broader New York City area', 'Participants who met inclusion and exclusion criteria', 'people with migraine', 'Participants (M age\xa0']","['mindfulness-based cognitive therapy for migraine (MBCT-M', 'individual MBCT-M sessions or 8 weeks of waitlist/treatment as usual (WL/TAU', 'MBCT-M', 'WL/TAU', 'MBCT']","['change from Month 0 to Month 4 in the headache disability inventory (HDI) and the Migraine Disability Assessment (MIDAS) (total score\xa0≥\xa021 indicating severe disability); secondary outcomes (headache days/30\xa0days, average headache attack pain intensity, and attack-level migraine-related disability [Migraine Disability Index (MIDI', 'moderate level of disability', 'Mean MIDI scores', 'headache-related disability and attack-level migraine-related disability', 'average HDI score', 'Severe Disability"" category fell', 'Severe Disability"" range', 'headache days/30 days an average headache attack pain intensity', 'average headache attack pain intensity', 'daily headache diary', 'headache diary', 'Average levels of daily disability']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0556971', 'cui_str': 'days/month (qualifier value)'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",60.0,0.137579,"For the HDI, mean scores decreased more from Month 0 to Month 4 in the MBCT-M group (-14.3) than the waitlist/treatment as an usual group (-0.2; P < .001).","[{'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Seng', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Singer', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Metts', 'Affiliation': 'Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Grinberg', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Zarine S', 'Initials': 'ZS', 'LastName': 'Patel', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Marzouk', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Headache,['10.1111/head.13657']
1078,31569307,The Effects of Goal Framing on Energy Drink Consumption: The Moderating Role of Temporal Framing.,"BACKGROUND


With the rapid expansion of the energy drink market, concerns associated with its adverse effects have been raised. This research examines how goal framing moderated by temporal framing affects attitude, subjective norm, and perceived behavioral control related to energy drink consumption.
METHODS


A 2 (goal framing: gain vs. loss) × 2 (temporal framing: present-oriented vs. future-oriented) randomised experiment was employed. The sample consisted of 195 college students who consume energy drinks.
RESULTS


Results showed that a future-oriented message was more effective than a present-oriented one when used in gain framing in increasing perceived behavioral control, as predicted. A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
CONCLUSIONS


The findings extend previous research on goal framing by (1) identifying an important moderator-temporal framing-in processing health promotion messages about energy drink consumption and (2) examining such moderated effects on different psychological factors. The findings of this study are expected to inform the development of more effective message strategies in health domains.",2020,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
",['195 college students who consume energy drinks'],[],['Energy Drink Consumption'],"[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]",[],"[{'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0554904,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
","[{'ForeName': 'Jarim', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Yonsei University, Seoul, Republic of Korea.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12184']
1079,31405764,"Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study.","INTRODUCTION


Erectile dysfunction is common after radical prostatectomy because of damage to the cavernous nerves. Thus, it is important to identify new ways to avoid this problem. For example, statins have shown positive effects on erectile function and may have anti-inflammatory effects that improve recovery after surgery.
AIM


The aim of this exploratory analysis of a subgroup from ESTO1, a randomized, double-blind, placebo-controlled study, was to evaluate the preoperative use of atorvastatin on erectile function after radical prostatectomy.
METHOD


Patients were randomized to either 80 mg atorvastatin or placebo daily before undergoing radical prostatectomy from study inclusion to the day of surgery. Altogether 118 men with prostate cancer and scheduled for radical prostatectomy were asked to fill out the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire before surgery and at 3, 6, 9, and 12 months after surgery.
MAIN OUTCOME MEASUREMENTS


The study was exploratory, with the main outcome being the overall difference between IIEF-5 scores in the 2 groups at 12 months. Several hypotheses generating sub-analyses were conducted.
RESULTS


Overall, 85% filled out the IIEF-5 questionnaire before their operation and 85%, 81%, 78%, and 78% completed it at 3, 6, 9, and 12 months follow-up, respectively. 52% of men had information available at all time points. There were no statistically significant differences between the groups at baseline in either erectile function, comorbidities, or tumor characteristics. The median duration of use of atorvastatin and placebo before surgery was 27 and 25 days, respectively. Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm. Furthermore, atorvastatin treatment compared with placebo improved IIEF-5 scores at 12 months after surgery when the cavernous nerves were at least partially intact bilaterally (P < .04, n = 65); however, after full bilateral or unilateral nerve-sparing, the difference was not statistically significant.
CLINICAL IMPLICATION


Short-term statin treatment did not improve recovery of erectile function after prostatectomy; however, further studies are needed before final conclusions.
STRENGTHS & LIMITATIONS


This was a randomized placebo-controlled study. Original ESTO1 study was designed to detect a difference in prostate cancer biomarkers.
CONCLUSION


Short-term atorvastatin treatment before radical prostatectomy had no statistically significant effect on the recovery of erectile functions in a non-selected cohort of patients undergoing radical prostatectomy. Further studies will be needed to clarify the role of long-term atorvastatin use before and after prostatectomy. Siltari A, Riikonen J, Fode M, et al. Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study. J Sex Med 2019;16:1597-1605.",2019,"Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm.","['Altogether 118 men with prostate cancer and scheduled for', 'Patients', 'patients undergoing radical prostatectomy']","['atorvastatin', 'Preoperative Atorvastatin', 'Preoperative atorvastatin', 'Radical Prostatectomy', 'atorvastatin and placebo', 'placebo', 'Preoperative Atorvastatin Treatment', 'atorvastatin or placebo', 'Short-term atorvastatin', 'radical prostatectomy', 'Placebo']","['erectile function, comorbidities, or tumor characteristics', 'Erectile Function', 'erectile function', 'recovery of erectile functions', 'IIEF-5 scores', 'IIEF-5 questionnaire']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",118.0,0.186472,"Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Siltari', 'Affiliation': 'Tampere University, Faculty of Medicine and Life Sciences, Tampere, Finland. Electronic address: aino.siltari@helsinki.fi.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Tampere University Hospital, Department of Urology, Tampere, Finland.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Fode', 'Affiliation': 'Herlev and Gentofte Hospital, Department of Urology, Herlev, Denmark.'}, {'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Tampere University, Faculty of Medicine and Life Sciences, Tampere, Finland; Tampere University Hospital, Department of Urology, Tampere, Finland; Seinäjoki Central Hospital, Department of Surgery, Seinäjoki, Finland.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.07.001']
1080,28120248,A randomized controlled clinical and histopathological trial comparing excisional biopsies of oral fibrous hyperplasias using CO 2  and Er:YAG laser.,"This study was conducted in order to compare clinical and histopathological outcomes for excisional biopsies when using pulsed CO 2  laser versus Er:YAG laser. Patients (n = 32) with a fibrous hyperplasia in the buccal mucosa were randomly allocated to the CO 2  (140 Hz, 400 μs, 33 mJ) or the Er:YAG laser (35 Hz, 297 μs, 200 mJ) group. The duration of excision, intraoperative bleeding and methods to stop the bleeding, postoperative pain (VAS; ranging 0-100), the use of analgesics, and the width of the thermal damage zone (μm) were recorded and compared between the two groups. The median duration of the intervention was 209 s, and there was no significant difference between the two methods. Intraoperative bleeding occurred in 100% of the excisions with Er:YAG and 56% with CO 2  laser (p = 0.007). The median thermal damage zone was 74.9 μm for CO 2  and 34.0 μm for Er:YAG laser (p < 0.0001). The median VAS score on the evening after surgery was 5 for the CO 2  laser and 3 for the Er:YAG group. To excise oral soft tissue lesions, CO 2  and Er:YAG lasers are both valuable tools with a short time of intervention and postoperative low pain. More bleeding occurs with the Er:YAG than CO 2  laser, but the lower thermal effect of Er:YAG laser seems advantageous for histopathological evaluation.",2017,Intraoperative bleeding occurred in 100% of the excisions with Er:YAG and 56% with CO 2  laser (p = 0.007).,['Patients (n\u2009=\u200932) with a fibrous hyperplasia in the buccal mucosa'],"['pulsed CO 2  laser versus Er:YAG laser', 'excisional biopsies of oral fibrous hyperplasias using CO 2  and Er:YAG laser', 'Er:YAG laser']","['median thermal damage zone', 'Intraoperative bleeding', 'median VAS score', 'median duration of the intervention', 'duration of excision, intraoperative bleeding and methods to stop the bleeding, postoperative pain (VAS; ranging 0-100), the use of analgesics, and the width of the thermal damage zone (μm']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439709', 'cui_str': 'Fibrous (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C1578559', 'cui_str': 'Intraoral surface of cheek'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0457903', 'cui_str': 'Erbium YAG Lasers'}, {'cui': 'C0184921', 'cui_str': 'Excisional biopsy (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439709', 'cui_str': 'Fibrous (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",,0.0326215,Intraoperative bleeding occurred in 100% of the excisions with Er:YAG and 56% with CO 2  laser (p = 0.007).,"[{'ForeName': 'Valerie G A', 'Initials': 'VGA', 'LastName': 'Suter', 'Affiliation': 'Department of Oral Surgery and Stomatology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hans Jörg', 'Initials': 'HJ', 'LastName': 'Altermatt', 'Affiliation': 'Pathology Länggasse, Bern, Switzerland.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Bornstein', 'Affiliation': 'Department of Oral Surgery and Stomatology, School of Dental Medicine, University of Bern, Bern, Switzerland. bornst@hku.hk.'}]",Lasers in medical science,['10.1007/s10103-017-2151-8']
1081,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1082,31563517,"Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial.","BACKGROUND


IL-10 has anti-inflammatory and CD8+ T-cell stimulating activities. Pegilodecakin (pegylated IL-10) is a first-in-class, long-acting IL-10 receptor agonist that induces oligoclonal T-cell expansion and has single-agent activity in advanced solid tumours. We assessed the safety and activity of pegilodecakin with anti-PD-1 monoclonal antibody inhibitors in patients with advanced solid tumours.
METHODS


We did a multicentre, multicohort, open-label, phase 1b trial (IVY) at 12 cancer research centres in the USA. Patients were assigned sequentially into cohorts. Here, we report on all enrolled patients from two cohorts treated with pegilodecakin combined with anti-PD-1 inhibitors. Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients with uncontrolled infectious diseases were excluded. Pegilodecakin was provided in single-use 3 mL vials and was self-administered subcutaneously by injection at home at 10 μg/kg or 20 μg/kg once per day in combination with pembrolizumab (2 mg/kg every 3 weeks or 200 mg every 3 weeks) or nivolumab (3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks at the approved dosing), both of which were given intravenously at the study site. Patients received pembrolizumab or nivolumab with pegilodecakin until disease progression, toxicity necessitating treatment discontinuation, patient withdrawal of consent, or study end. The primary endpoints were safety and tolerability, assessed in all patients enrolled in the study who received any amount of study medication including at least one dose of pegilodecakin, and pharmacokinetics (previously published). Secondary endpoints included objective response by immune-related response criteria in all patients who were treated and had evaluable measurements. The study is active but no longer recruiting, and is registered with ClinicalTrials.gov, NCT02009449.
FINDINGS


Between Feb 13, 2015, and Sept 12, 2017, 111 patients were enrolled in the two cohorts. 53 received pegilodecakin plus pembrolizumab, and 58 received pegilodecakin plus nivolumab. 34 (31%) of 111 patients had non-small-cell lung cancer, 37 (33%) had melanoma, and 38 (34%) had renal cell carcinoma; one (<1%) patient had triple-negative breast cancer and one (<1%) had bladder cancer. Data cutoff was July 1, 2018. Median follow-up was 26·9 months (IQR 22·3-31·5) for patients with non-small-cell lung cancer, 33·0 months (29·2-35·1) for those with melanoma, and 22·7 months (20·9-27·0) for those with renal cell carcinoma. At least one treatment-related adverse event occurred in 103 (93%) of 111 patients. Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group). There were no fatal adverse events determined to be related to the study treatments. Of the patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma).
INTERPRETATION


In this patient population, pegilodecakin with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumour activity. Pegilodecakin with pembrolizumab or nivolumab could provide a new therapeutic opportunity for previously treated patients with renal cell carcinoma and non-small-cell carcinoma.
FUNDING


ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company.",2019,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","['Patients with uncontrolled infectious diseases', '111 patients were enrolled in the two cohorts', 'patients with advanced solid tumours (IVY', 'patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma', 'previously treated patients with renal cell carcinoma and non-small-cell carcinoma', 'Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1', '12 cancer research centres in the USA', 'patients with advanced solid tumours']","['pegilodecakin plus nivolumab', 'pembrolizumab', 'pegilodecakin combined with anti-PD-1 inhibitors', 'pembrolizumab or nivolumab with pegilodecakin', 'Pegilodecakin combined with pembrolizumab or nivolumab', 'pegilodecakin with anti-PD-1 monoclonal antibody inhibitors', 'nivolumab', 'pegilodecakin plus pembrolizumab', 'Pegilodecakin (pegylated IL-10', 'Pegilodecakin', 'Pegilodecakin with pembrolizumab or nivolumab']","['Grade 3 or 4 events', 'thrombocytopenia', 'anaemia', 'fatal adverse events', 'bladder cancer', 'non-small-cell lung cancer', 'objective response by immune-related response criteria', 'renal cell carcinoma', 'adverse event', 'safety and activity', 'hypertriglyceridaemia', 'fatigue', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0446290', 'cui_str': 'Ivy (organism)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1266002', 'cui_str': 'Non-small cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",111.0,0.307663,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","[{'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Naing', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA. Electronic address: anaing@mdanderson.org.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Korn', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kyriakos P', 'Initials': 'KP', 'LastName': 'Papadopoulos', 'Affiliation': 'START Center for Cancer Care, San Antonio, TX, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Autio', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Pant', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Naval G', 'Initials': 'NG', 'LastName': 'Daver', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hung', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Ratti', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Vlasselaer', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Eli Lilly and Company, New York City, NY, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Oft', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30514-5']
1083,28078503,Efficacy of pulsed Nd:YAG laser in the treatment of patients with knee osteoarthritis: a randomized controlled trial.,"The purpose of this study was to investigate the effects of pulsed Nd:YAG laser plus glucosamine/chondroitin sulfate (GCS) in patients with knee osteoarthritis (KOA) by examining changes in pain and knee function, as well as synovial thickness (ST) and femoral cartilage thickness (FCT). Sixty-seven male patients participated, with a mean (SD) age of 53.85 (4.39) years, weight of 84.01 (4.70) kg, height of 171.51 (3.96) cm, and BMI of 28.56 (1.22). Group 1 was treated with high-intensity laser therapy (HILT), GCS, and exercises (HILT + GCS + EX). Group 2 was treated with GCS plus exercises (GCS + EX), and group 3 received placebo laser plus exercises (PL + EX). The outcomes measured were pain level and functional disability using the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively. ST and FCT were measured by ultrasound examination. Statistical analyses were performed to compare differences between baseline and after 6 weeks of treatment and then after 3 months of follow-up. Statistical significance was set at p < 0.05. VAS and WOMAC were significantly decreased in all groups after 6 weeks, with nonsignificant differences between 6 weeks and 3 months of follow-up. ST was significantly decreased in the HILT + GCS + EX group posttreatment, with nonsignificant decreases in the GCS + EX and PL + EX groups, as well as nonsignificant differences to FCT in all groups. Overall, pulsed Nd:YAG laser combined with GCS and exercises was more effective than GCS + EX and exercises alone in the treatment of KOA patients.",2017,"VAS and WOMAC were significantly decreased in all groups after 6 weeks, with nonsignificant differences between 6 weeks and 3 months of follow-up.","['patients with knee osteoarthritis', 'KOA patients', 'patients with knee osteoarthritis (KOA', 'Sixty-seven male patients participated, with a mean (SD) age of 53.85 (4.39) years, weight of 84.01 (4.70) kg, height of 171.51 (3.96) cm, and BMI of 28.56 (1.22']","['GCS plus exercises (GCS\u2009+\u2009EX', 'placebo laser plus exercises (PL\u2009+\u2009EX', 'pulsed Nd:YAG laser combined with GCS and exercises', 'pulsed Nd:YAG laser', 'high-intensity laser therapy (HILT), GCS, and exercises (HILT\u2009+\u2009GCS\u2009+\u2009EX', 'pulsed Nd:YAG laser plus glucosamine/chondroitin sulfate (GCS']","['pain level and functional disability using the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'synovial thickness (ST) and femoral cartilage thickness (FCT', 'ST', 'ST and FCT', 'VAS and WOMAC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}]",67.0,0.0173485,"VAS and WOMAC were significantly decreased in all groups after 6 weeks, with nonsignificant differences between 6 weeks and 3 months of follow-up.","[{'ForeName': 'Mohamed Salaheldien Mohamed', 'Initials': 'MSM', 'LastName': 'Alayat', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia. mohsalahpt@hotmail.com.'}, {'ForeName': 'Tarek Helmy Ahmed', 'Initials': 'THA', 'LastName': 'Aly', 'Affiliation': 'Radiology Department, Um Al-Qura University Medical Center, Mecca, Saudi Arabia.'}, {'ForeName': 'Aly Elsayed Mohamed', 'Initials': 'AEM', 'LastName': 'Elsayed', 'Affiliation': 'Al-Noor Specialist Hospital, Mecca, Saudi Arabia.'}, {'ForeName': 'Ammar Suliman Mohamed', 'Initials': 'ASM', 'LastName': 'Fadil', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia.'}]",Lasers in medical science,['10.1007/s10103-017-2141-x']
1084,28233071,"Long-term effects of pulsed high-intensity laser therapy in the treatment of post-burn pruritus: a double-blind, placebo-controlled, randomized study.","We assessed the long-term effects of pulsed high-intensity laser therapy (HILT) in post-burn pruritus treatment. A total of 49 adult burn patients with mean age of 31.53 ± 10.14 years participated, with 24 patients randomly assigned to the active laser group (ALG) and 25 in the placebo laser group (PLG). The ALG received HILT three times per week for 6 weeks, while the PLG received placebo HILT. Both groups received 10-mg cetirizine tablets twice daily and 10 mg at bedtime. All patients were advised to massage their burn scars with coconut oil for 5 min four times daily. The outcomes measured were the itch severity scale (ISS), impairment of pruritus-related quality of life (QoL), pain level by the visual analog scale (VAS), hand grip strength by handheld dynamometer, and daily cetirizine intake. Repeated-measures ANOVA was used to compare the baseline and post-treatment measurements and after 12 weeks of follow-up. Statistical significance was set at P < 0.05. ISS decreased significantly in the ALG after 6 weeks of treatment and after 12 weeks of follow-up compared with the PLG. The QoL results showed a significant improvement in the ALG compared with the PLG, which continued after 12 weeks. VAS results significantly decrease, hand grip strength significantly improved, and cetirizine intake significantly decreased post-treatment in the ALG relative to the PLG. HILT combined with cetirizine seems more effective in patients with post-burn pruritus than a placebo laser procedure with cetirizine.",2017,ISS decreased significantly in the ALG after 6 weeks of treatment and after 12 weeks of follow-up compared with the PLG.,"['post-burn pruritus', 'post-burn pruritus treatment', 'patients with post-burn pruritus', '49 adult burn patients with mean age of 31.53\u2009±\u200910.14\xa0years participated, with 24 patients randomly assigned to the']","['10-mg cetirizine', 'placebo', 'cetirizine', 'pulsed high-intensity laser therapy (HILT', 'active laser group (ALG) and 25 in the placebo laser group (PLG', 'placebo HILT', 'pulsed high-intensity laser therapy']","['hand grip strength', 'itch severity scale (ISS', 'impairment of pruritus-related quality of life (QoL), pain level by the visual analog scale (VAS), hand grip strength by handheld dynamometer, and daily cetirizine intake', 'ISS']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}]",49.0,0.1002,ISS decreased significantly in the ALG after 6 weeks of treatment and after 12 weeks of follow-up compared with the PLG.,"[{'ForeName': 'Anwar Abdelgayed', 'Initials': 'AA', 'LastName': 'Ebid', 'Affiliation': 'Department of Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt. anwar.ebid@cu.edu.eg.'}, {'ForeName': 'Abeer Ramadan', 'Initials': 'AR', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohammed Taher', 'Initials': 'MT', 'LastName': 'Omar', 'Affiliation': 'Department of Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Amal Mohamed Abd', 'Initials': 'AMA', 'LastName': 'El Baky', 'Affiliation': 'Department of Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Lasers in medical science,['10.1007/s10103-017-2172-3']
1085,31575503,"Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib has the potential to optimise antitumour activity while minimising myelotoxicity. We report safety and activity data for trilaciclib plus gemcitabine and carboplatin chemotherapy in patients with metastatic triple-negative breast cancer.
METHODS


In this randomised, open-label, multicentre, phase 2 study, adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals. Availability of diagnostic samples of tumour tissue confirming triple-negative breast cancer was a prerequisite for enrolment. Eligible patients were randomly assigned (1:1:1) by an interactive web-response system, stratified by number of previous lines of systemic therapy and the presence of liver metastases, to receive intravenous gemcitabine 1000 mg/m 2  and intravenous carboplatin (area under the concentration-time curve 2 μg × h/mL) on days 1 and 8 (group 1), gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2  on days 1 and 8 (group 2), or gemcitabine and carboplatin on days 2 and 9 plus trilaciclib on days 1, 2, 8, and 9 (group 3) of 21-day cycles. Patients continued treatment until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation by the investigator. The primary objective was to assess the safety and tolerability of combining trilaciclib with gemcitabine and carboplatin chemotherapy. The primary endpoints were duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia during the treatment period. Overall survival was included as a key secondary endpoint. Analyses were in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered with EudraCT, 2016-004466-26, and ClinicalTrials.gov, NCT02978716, and is ongoing but closed to accrual.
FINDINGS


Between Feb 7, 2017, and May 15, 2018, 142 patients were assessed for eligibility and 102 were randomly assigned to group 1 (n=34), group 2 (n=33), or group 3 (n=35). Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting. Median follow-up was 8·4 months (IQR 3·8-13·6) for group 1, 12·7 months (5·5-17·4) for group 2, and 12·9 months (6·7-16·8) for group 3. Data cutoff for myelosuppression endpoints was July 30, 2018, and for antitumour activity endpoints was May 17, 2019. During cycle 1, mean duration of severe neutropenia was 0·8 day (SD 2·4) in group 1, 1·5 days (3·5) in group 2, and 1·0 day (2·6) in group 3 (group 3 vs group 1 one-sided adjusted p=0·70). Severe neutropenia occurred in nine (26%) of 34 patients in group 1, 12 (36%) of 33 patients in group 2, and eight (23%) of 35 patients in group 3 (p=0·70). Overall survival was 12·6 months (IQR 5·8-15·6) in group 1, 20·1 months (9·4-not reached) in group 2, and 17·8 months (8·8-not reached) in group 3 (group 3 vs group 1 two-sided p=0·0023). The most common treatment-emergent adverse events were anaemia (22 [73%] of 34), neutropenia (21 [70%]), and thrombocytopenia (18 [60%]) in group 1; neutropenia (27 [82%] of 33), thrombocytopenia (18 [55%]) and anaemia (17 [52%]) in group 2; and neutropenia (23 [66%] of 35), thrombocytopenia (22 [63%]), and nausea (17 [49%]) in group 3. There were no treatment-related deaths.
INTERPRETATION


No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging. Further studies of trilaciclib in this setting are warranted.
FUNDING


G1 Therapeutics.",2019,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","['Between Feb 7, 2017, and May 15, 2018', '142 patients were assessed for eligibility and 102', 'adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals', 'Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting', 'patients with metastatic triple-negative breast cancer', 'Eligible patients']","['gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2  on days 1 and 8 (group 2), or gemcitabine and carboplatin', 'chemotherapy alone', 'gemcitabine 1000 mg/m 2  and intravenous carboplatin', 'Trilaciclib plus chemotherapy', 'trilaciclib plus gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin']","['Safety', 'anaemia', 'Severe neutropenia', 'neutropenia', 'myelosuppression endpoints', 'unacceptable toxicity, withdrawal of consent, or discontinuation', 'mean duration of severe neutropenia', 'nausea', 'tolerated and overall survival', 'thrombocytopenia', 'Overall survival', 'duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",142.0,0.0748289,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","[{'ForeName': 'Antoinette R', 'Initials': 'AR', 'LastName': 'Tan', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA. Electronic address: antoinette.tan@atriumhealth.org.'}, {'ForeName': 'Gail S', 'Initials': 'GS', 'LastName': 'Wright', 'Affiliation': 'Florida Cancer Specialists and Research Institute, New Port Richey, FL, USA.'}, {'ForeName': 'Anu R', 'Initials': 'AR', 'LastName': 'Thummala', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Danso', 'Affiliation': 'Virginia Oncology Associates, Norfolk, VA, USA.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Popovic', 'Affiliation': 'Oncology Institute of Vojvodina, University of Novi Sad, Serbia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Pluard', 'Affiliation': ""Saint Luke's Cancer Institute, Kansas City, MO, USA.""}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Vojnović', 'Affiliation': 'Varaždin General Hospital, Varaždin, Croatia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Vasev', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, Skopje, Macedonia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Rocky Mountain Cancer Centers, Lakewood, CO, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology-Tyler, US Oncology Research, Tyler, TX, USA.'}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Wilks', 'Affiliation': 'Texas Oncology-San Antonio, US Oncology Research, San Antonio, TX, USA.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Milenković', 'Affiliation': 'Clinical Center Niš, Niš, Serbia.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology Dallas, US Oncology Research, Dallas, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30616-3']
1086,28127644,Efficacy and safety of far infrared radiation in lymphedema treatment: clinical evaluation and laboratory analysis.,"Swelling is the most common symptom of extremities lymphedema. Clinical evaluation and laboratory analysis were conducted after far infrared radiation (FIR) treatment on the main four components of lymphedema: fluid, fat, protein, and hyaluronan. Far infrared radiation is a kind of hyperthermia therapy with several and additional benefits as well as promoting microcirculation flow and improving collateral lymph circumfluence. Although FIR therapy has been applied for several years on thousands of lymphedema patients, there are still few studies that have reported the biological effects of FIR on lymphatic tissue. In this research, we investigate the effects of far infrared rays on the major components of lymphatic tissue. Then, we explore the effectiveness and safety of FIR as a promising treatment modality of lymphedema. A total of 32 patients affected by lymphedema in stage II and III were treated between January 2015 and January 2016 at our department. After therapy, a significant decrease of limb circumference measurements was noted and improving of quality of life was registered. Laboratory examination showed the treatment can also decrease the deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition. We believe FIR treatment could be considered as both an alternative monotherapy and a useful adjunctive to the conservative or surgical lymphedema procedures. Furthermore, the real and significant biological effects of FIR represent possible future applications in wide range of the medical field.",2017,"Laboratory examination showed the treatment can also decrease the deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition.",['32 patients affected by lymphedema in stage II and III were treated between January 2015 and January 2016 at our department'],['FIR therapy'],"['limb circumference measurements', 'effectiveness and safety of FIR', 'quality of life', 'Efficacy and safety', 'deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0424682', 'cui_str': 'Circumference measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C0034380'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",32.0,0.0380876,"Laboratory examination showed the treatment can also decrease the deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Ning Fei', 'Initials': 'NF', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shao Qing', 'Initials': 'SQ', 'LastName': 'Feng', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': ""Department of Medical Cosmetology Surgery, Jinhua People's Hospital, Jinhua, China.""}, {'ForeName': 'Ju Fang', 'Initials': 'JF', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Cosmetology Surgery, Hangzhou First People's Hospital, Hangzhou, China. zhjuf@vip.ina.com.cn.""}, {'ForeName': 'Joannis', 'Initials': 'J', 'LastName': 'Constantinides', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Guy's and Saint Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lazzeri', 'Affiliation': 'Plastic Reconstructive and Aesthetic Surgery, Villa Salaria Clinic, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Grassetti', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Marche Polytechnic University, Ancona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Nicoli', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Guy's and Saint Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Yi Xin', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China. zhangyixin6688@hotmail.com.""}]",Lasers in medical science,['10.1007/s10103-016-2135-0']
1087,32037749,Effect of 0.1% Bromfenac for Preventing Macular Edema after Cataract Surgery in Patients with Diabetes.,"PURPOSE


To investigate the effect of 0.1% bromfenac sodium hydrate ophthalmic solution for prevention of macular edema after cataract surgery in patients with diabetes.
METHODS


A retrospective analysis of 75 patients with diabetes who underwent cataract surgery was performed. Thirty-eight patients (52 eyes) were instilled with 0.1% bromfenac solution (bromfenac group) and 37 patients (46 eyes) were not (control group).
RESULTS


There were no significant preoperative between-group differences. Compared to the control group, at 1 month after surgery, the bromfenac group showed slightly better best-corrected visual acuity (0.12 ± 0.12 vs. 0.32 ± 0.42,  p  = 0.142), lower central macular thickness (265.58 ± 31.28 vs. 314.15 ± 76.11 μm,  p  < 0.001), and lower macular volume (8.46 ± 0.60 vs. 9.14 ± 1.53 mm³,  p  = 0.022). There were no significant differences between the two groups at 4 and 6 months postoperatively ( p  > 0.05). Mean changes in central macular thickness showed significant differences at 1 and 4 months postoperatively (-1.44 ± 11.72 and 10.44 ± 22.48 μm in bromfenac group vs. 47.19 ± 70.24 and 31.69 ± 48.04 μm in control group,  p  < 0.001 and  p  = 0.016) and mean changes in macular volume showed a significant difference at 1 month postoperatively (-0.08 ± 0.47 mm³ in bromfenac group vs. 0.58 ± 1.28 mm³ in control group,  p  < 0.001). There were no significant differences thereafter ( p  > 0.05).
CONCLUSIONS


Treatment with 0.1% bromfenac sodium hydrate ophthalmic solution showed good efficacy for preventing cystoid macular edema early after cataract surgery in patients with diabetes.",2020,There were no significant differences between the two groups at 4 and 6 months postoperatively ( p  > 0.05).,"['patients with diabetes', 'Thirty-eight patients (52 eyes', 'Patients with Diabetes', '75 patients with diabetes who underwent cataract surgery was performed']",['sodium hydrate ophthalmic solution'],"['lower central macular thickness', 'lower macular volume', 'macular edema', 'Mean changes in central macular thickness', 'macular volume', 'Macular Edema', 'slightly better best-corrected visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",75.0,0.0240967,There were no significant differences between the two groups at 4 and 6 months postoperatively ( p  > 0.05).,"[{'ForeName': 'Seok Hyeon', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Seung Kook', 'Initials': 'SK', 'LastName': 'Baek', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Min Woo', 'Initials': 'MW', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Konyang University College of Medicine, Daejeon, Korea. astrix001@kyuh.ac.kr.'}]",Korean journal of ophthalmology : KJO,['10.3341/kjo.2019.0044']
1088,32415684,"Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects.","AIMS


Selexipag is a prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension. Cytochrome P450 (CYP) 2C8 is involved in the metabolism of selexipag and its active metabolite, ACT-333679. This study evaluated the interaction of selexipag and clopidogrel, a CYP2C8 inhibitor.
METHODS


The study had a 2-treatment, 1-sequence, crossover design. Pharmacokinetics (PK) and CYP2C8 genotype were assessed in healthy male subjects administered selexipag (200 μg twice daily [b.i.d.]) alone or with clopidogrel (300 mg single dose or 75 mg once daily [o.d.]). PK modelling and simulation were conducted to support dosing recommendations.
RESULTS


Clopidogrel had a comparatively small effect on selexipag (<1.5-fold difference in any PK variable). For ACT-333679, the major contributor to the drug effect, the area under the plasma concentration-time curve during a dose interval and the maximum plasma concentration increased 2.25-fold (90% confidence interval [CI] 2.06, 2.46) and 1.69-fold (90% CI 1.55, 1.84), respectively with clopidogrel 300 mg and 2.70-fold (90% CI 2.45, 2.96) and 1.90-fold (90% CI 1.72, 2.11), respectively with clopidogrel 75 mg. The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes. PK simulations predicted comparable exposure to ACT-333679 following selexipag 400 μg b.i.d., 400 μg o.d. in combination with clopidogrel 75 mg o.d and 200 μg b.i.d. with clopidogrel 75 mg o.d.
CONCLUSION


Results suggest that ACT-333679 exposure can be maintained within the therapeutic range by reducing selexipag dosing frequency to o.d. or dose to half, when selexipag is coadministered with clopidogrel.",2020,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"['pulmonary arterial hypertension', 'healthy male subjects administered', 'healthy subjects']","['selexipag', 'selexipag and clopidogrel, a CYP2C8 inhibitor', 'clopidogrel', 'clopidogrel 75 mg o.d', 'Clopidogrel']","['Pharmacokinetics (PK) and CYP2C8 genotype', 'maximum plasma concentration (C max  ', 'plasma concentration-time curve', 'selexipag']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2000145', 'cui_str': 'selexipag'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3850061', 'cui_str': 'P450 CYP2C8 Inhibitors'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1382144', 'cui_str': 'Cytochrome p450 CYP2C8 enzyme'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C2000145', 'cui_str': 'selexipag'}]",,0.0966444,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"[{'ForeName': 'Lene Nygaard', 'Initials': 'LN', 'LastName': 'Axelsen', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Poggesi', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Rasschaert', 'Affiliation': 'Clinical Pharmacology Unit, Janssen Pharmaceutica NV, Merksem, Belgium.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Perez Ruixo', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bruderer', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14365']
1089,31849085,Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure.,"BACKGROUND AND AIMS


Paracentesis-induced circulatory dysfunction (PICD) is a serious complication of large-volume (>5 L) paracentesis in cirrhosis and is reduced with albumin infusion. There is a lack of data on PICD in acute-on-chronic liver failure (ACLF). Because ACLF patients have greater hemodynamic derangements than patients with decompensated cirrhosis, we investigated whether PICD could develop with modest-volume paracentesis (MVP) and the role of albumin infusion.
APPROACH AND RESULTS


A total of 80 ACLF patients undergoing <5 L paracentesis were randomized to receive albumin (8 g/dL of ascitic fluid; n = 40) or no albumin (n = 40) and serially followed to detect PICD. Baseline characteristics were comparable between groups, including volume of ascitic tap (4.16 ± 0.23 versus 4.14 ± 0.27 L; P = 0.72) and plasma renin activity (PRA; 20.5 ± 7.03 versus 23.2 ± 8.24 ng/mL/hour; P = 0.12). PICD was more frequent in the no-albumin group than the albumin group (70% versus 30%; P = 0.001), with higher incidence of hepatic encephalopathy (50% versus 27.5%; P = 0.04), hyponatremia (67.5% versus 22.5%; P < 0.001), acute kidney injury (62.5% versus 30%; P = 0.001), and in-house mortality (62.5% versus 27.5%; P = 0.003). PRA of 25.15 ng/mL at day 3 had sensitivity and specificity of 71% and 68%, respectively, for development of PICD at day 6. Albumin infusion decreased the incidence of PICD at day 6 (odds ratio, 0.068; 95% confidence interval, 0.011-0.43; P = 0.005).
CONCLUSIONS


PICD is common and develops even with MVP in ACLF patients. Albumin infusion decreases the incidence of PICD and mortality in patients with ACLF. Clinical trial identifier: NCT02467348.",2019,"Albumin infusion decreased the incidence of PICD at day six (odds ratio, 0.068; 95% confidence interval, 0.011-0.43; P = 0.005).","['patients with decompensated cirrhosis', '80 ACLF patients undergoing <5 L paracentesis', 'ACLF patients']","['Albumin infusion', 'Paracentesis-induced circulatory dysfunction (PICD', 'no albumin', 'albumin']","['house mortality', 'incidence of PICD and mortality', 'hyponatremia', 'volume of ascitic tap', 'sensitivity and specificity', 'hemodynamic derangements', 'acute kidney injury', 'PICD', 'hepatic encephalopathy', 'incidence of PICD', 'plasma renin activity (PRA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1619727', 'cui_str': 'Decompensated cirrhosis of liver (disorder)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439685', 'cui_str': 'Ascitic (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.248602,"Albumin infusion decreased the incidence of PICD at day six (odds ratio, 0.068; 95% confidence interval, 0.011-0.43; P = 0.005).","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Amrish', 'Initials': 'A', 'LastName': 'Sahney', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Sherin Sarah', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Department of Biochemistry, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rehmat', 'Initials': 'R', 'LastName': 'Ali', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31071']
1090,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND


Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences.
METHODS


Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day.
RESULTS


On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
CONCLUSIONS


Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077']
1091,31564512,Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study.,"PURPOSE


Celecoxib is a selective cyclooxygenase-2 inhibitor widely used in patients with osteoarthritis and rheumatoid arthritis. Recently, nonclinical data on the inhibition of human ether-à-go-go-related gene potassium channels by celecoxib were reported, but there is no compelling evidence for this finding in humans. The aim of this study was to assess the potential effects of celecoxib on cardiac repolarization by conducting a thorough QT study, which was designed in compliance with the related guidelines.
METHODS


This randomized, open-label, positive- and negative-controlled, crossover clinical study was conducted in healthy male and female subjects. Each subject received, in 1 of 4 randomly assigned sequences, all of the following 3 interventions: celecoxib 400 mg once daily for 6 days; a single dose of moxifloxacin 400 mg, which served as a positive control to assess the assay sensitivity; and water without any drug, which served as a negative control. Serial 12-lead ECG and blood samples for pharmacokinetic analysis were collected periodically over 24 h. Individually RR-corrected QT intervals (QTcI) and Fridericia method-corrected QT intervals (QTcF) were calculated and evaluated.
FINDINGS


Twenty-eight subjects were allocated to 1 of the 4 intervention sequences. The largest time-matched mean effects of celecoxib on the QTcI and QTcF were <5 ms, and the upper bounds of the 1-sided 95% CIs of those values did not exceed 10 ms. Moreover, none of the subjects had an absolute QTcI value of >450 ms or a change from baseline in QTcI of >60 ms after multiple administrations of celecoxib. The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/L. The overall effects of moxifloxacin on the QTcI and QTcF were enough to establish assay sensitivity. No serious adverse events were reported, with a total of 11 AEs reported in 8 subjects.
IMPLICATIONS


Celecoxib caused no clinically relevant increase in the QT/QTc interval at the maximum dose level used in current practice settings. ClinicalTrials.gov identifier: NCT03822520.",2019,The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/,"['Twenty-eight subjects', 'healthy male and female subjects', 'patients with osteoarthritis and rheumatoid arthritis']","['Celecoxib', 'moxifloxacin', 'celecoxib', '41:XXX-XXX', 'celecoxib 400\xa0mg once daily for 6 days; a single dose of moxifloxacin 400\xa0mg, which served as a positive control to assess the assay sensitivity; and water without any drug, which served as a negative control']","['QT/QTc interval', 'cardiac repolarization', 'Individually RR-corrected QT intervals (QTcI) and Fridericia', 'absolute QTcI value', 'method-corrected QT intervals (QTcF', 'QTcI and QTcF', 'serious adverse events', 'QTc Interval']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1166422', 'cui_str': 'celecoxib 400 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.0782001,The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/,"[{'ForeName': 'Seokuee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeryeon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Wook', 'Initials': 'JW', 'LastName': 'Ko', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Ryul', 'Initials': 'JR', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea; Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea. Electronic address: jungryul.kim@gmail.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.004']
1092,31564513,"Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects.","PURPOSE


Hypertension is a major risk factor for cardiovascular diseases, necessitating hypertension control. Antihypertensive drugs are more potent when administered in combinations of 2 or 3 different classes of drugs. One such therapy includes a combination of an angiotensin receptor blocker, a calcium channel blocker, and a diuretic. The objective of this study was to evaluate the pharmacokinetic interaction among telmisartan, amlodipine, and hydrochlorothiazide.
METHODS


A randomized, open-label, 3-period, 6-sequence, 3-treatment, single-dose crossover study was conducted in healthy male subjects. Subjects were randomly assigned to 1 of 6 sequences and one of the following treatments was administered in each period: treatment A, co-administration of one tablet of telmisartan 80 mg and one tablet of amlodipine 10 mg; treatment B, one tablet of hydrochlorothiazide 25 mg alone; and treatment C, co-administration of all 3 investigational products. Serial blood samples were collected up to 144 hours postdose. Plasma drug concentrations were measured by using LC/MS-MS. Pharmacokinetic parameters, including C max  and AUC 0-last , were determined by using noncompartmental analysis. The geometric least squares mean ratios and associated 90% CIs of log-transformed C max  and AUC 0-last  for separate administration or co-administration were calculated to evaluate pharmacokinetic interactions.
FINDINGS


Twenty-seven subjects completed the study. The geometric least squares mean ratios and 90% CIs of C max  and AUC 0-last  were 1.02 (0.85-1.21) and 1.04 (0.97-1.13) for telmisartan; 1.00 (0.95-1.04) and 0.95 (0.91-0.99) for amlodipine; and 0.88 (0.82-0.96) and 0.86 (0.82-0.90) for hydrochlorothiazide, respectively. No serious adverse events were recorded, and all reported adverse events were of mild intensity.
IMPLICATIONS


The pharmacokinetic parameters of telmisartan, amlodipine, and hydrochlorothiazide when administered separately or co-administered were compared, and all the parameters met the criteria for pharmacokinetic equivalence. Combination therapy of these 3 drugs had no significant impact on the pharmacokinetic parameters of each drug. (ClinicalTrials.gov Identifier: NCT03889145).",2019,"No serious adverse events were recorded, and all reported adverse events were of mild intensity.
","['Twenty-seven subjects completed the study', 'Healthy Male Subjects', 'healthy male subjects']","['telmisartan, amlodipine, and hydrochlorothiazide', 'amlodipine', 'telmisartan 80\xa0mg and one tablet of amlodipine 10\xa0mg; treatment B, one tablet of hydrochlorothiazide 25\xa0mg alone; and treatment C, co-administration of all 3 investigational products', 'hydrochlorothiazide', 'Telmisartan, Amlodipine, and Hydrochlorothiazide']","['Serial blood samples', 'Pharmacokinetic parameters, including C max  and AUC 0-last', 'Plasma drug concentrations', 'pharmacokinetic interaction', 'pharmacokinetic parameters', 'serious adverse events']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C1607513', 'cui_str': 'telmisartan 80 MG [Micardis]'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1124794', 'cui_str': 'Amlodipine 10 MG'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0986526', 'cui_str': 'Hydrochlorothiazide 25 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",27.0,0.0236295,"No serious adverse events were recorded, and all reported adverse events were of mild intensity.
","[{'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, Republic of Korea; Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Republic of Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.020']
1093,32415721,"Effect of screening, brief intervention and referral to treatment for unhealthy alcohol and other drug use in mental health treatment settings: a randomized controlled trial.","AIMS


To test the efficacy of a brief intervention to reduce alcohol or drug use and to promote use of addiction services among patients seeking mental health treatment.
DESIGN AND SETTING


A multi-centre, longitudinal, two-group randomized controlled trial with randomization within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA.
PARTICIPANTS


A total of 718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days.
INTERVENTION AND COMPARATOR


A motivation-based brief intervention with personalized feedback (screening, brief intervention and referral to treatment (SBIRT) condition) (n = 354) or a health education session (control condition) (n = 364).
MEASUREMENTS


Primary outcomes included frequency of heavy drinking days, days of cannabis use and days of stimulant use at the primary end-point 3 months post-baseline. Secondary outcomes included frequency and abstinence from substance use out to a 12-month follow-up and the use of addiction treatment services.
FINDINGS


Participants in the SBIRT condition had fewer heavy drinking days [odds ratio (OR) = 0.53; 95% credible interval (CrI) = 0.48-0.6] and fewer days of stimulant use (OR = 0.58; 95% CrI = 0.50-0.66) at the 3-month follow-up compared with participants in the health education condition. Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (OR = 0.93; 95% CrI = 0.85-1.01). Secondary outcomes indicated sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use. No effects were observed on abstinence rates or use of addiction treatment services.
CONCLUSIONS


Screening and brief intervention for unhealthy alcohol and drug use in mental health treatment settings were effective at reducing the frequency of heavy drinking and stimulant use.",2020,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"['718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days', 'Mental Health Treatment Settings', 'A multi-centre, longitudinal, two-group randomised controlled trial with randomisation within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA PARTICIPANTS', 'patients seeking mental health treatment']","['AND COMPARATOR\n\n\nA motivation-based brief intervention with personalized feedback (Screening, Brief Intervention and Referral to Treatment (SBIRT) condition) (n=354) or a health education session (control condition']","['abstinence rates or use of addiction treatment services', 'frequency of heavy drinking days, days of cannabis use and days of stimulant use', 'heavy drinking days', 'frequency and abstinence from substance use out to a 12-month follow up and the use of addiction treatment services', 'sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",718.0,0.0866086,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"[{'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Karno', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Department of Biostatistics and School of Nursing, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Spear', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, CA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grella', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Kagan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15114']
1094,32416333,Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.,"Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.",2020,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"['symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD', '153 subjects at 27 centers are treated in the study', 'patients with longstanding persistent AF', 'patients with left atrial sizes up to 6 centimeters']","['minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation', 'catheter ablation', 'Epicardial and Endocardial RF Ablation', 'endocardial catheter ablation']","['freedom from AF/AFL/AF absent class I/III AAD', 'incidence of major adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475210', 'cui_str': 'cm'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014124', 'cui_str': 'Endocardial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",153.0,0.021211,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St. Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blauth', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Saumil', 'Initials': 'S', 'LastName': 'Oza', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mostovych', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Yashasvi', 'Initials': 'Y', 'LastName': 'Awasthi', 'Affiliation': 'AtriCure, Inc., Mason, OH. Electronic address: yawasthi@atricure.com.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc., Mason, OH.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Crossen', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}]",American heart journal,['10.1016/j.ahj.2020.02.016']
1095,32492705,Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults.,"OBJECTIVE


We compared the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on insulin sensitivity and other important metabolic adaptations in adults with obesity.
METHODS


Thirty-one inactive adults with obesity (age: 31 ± 6 years; body mass index: 33 ± 3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10 × 1-minute at 90%HRmax, 1-minute active recovery; n = 16) or MICT (45 minutes at 70%HRmax; n = 15). To assess the direct effects of exercise independent of weight/fat loss, participants were required to maintain body mass.
RESULTS


Training increased peak oxygen uptake by ~10% in both HIIT and MICT (P < 0.0001), and body weight/fat mass were unchanged. Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp) was ~20% greater the day after the final exercise session compared to pretraining (P < 0.01), with no difference between HIIT and MICT. When trained participants abstained from exercise for 4 days, insulin sensitivity returned to pretraining levels in both groups. HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism. Training-induced alterations in muscle lipid profile were also similar between groups.
CONCLUSION


Despite large differences in training intensity and exercise time, 12 weeks of HIIT and MICT induce similar acute improvements in peripheral insulin sensitivity the day after exercise, and similar longer term metabolic adaptations in skeletal muscle in adults with obesity. These findings support the notion that the insulin-sensitizing effects of both HIIT and MICT are mediated by factors stemming from the most recent exercise session(s) rather than adaptations that accrue with training.",2020,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"['adults with obesity', 'obese adults', 'Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or']","['MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT', 'HIIT and MICT', 'Moderate-intensity exercise and high-intensity interval training']","['muscle lipid profile', 'peak oxygen uptake', 'insulin sensitivity', 'Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'body weight/fat mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",31.0,0.0721815,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Cheehoon', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Ludzki', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Van Pelt', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Chenevert', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gioscia-Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Suzette M', 'Initials': 'SM', 'LastName': 'Howton', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rode', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa345']
1096,31561712,Evaluating the differential effectiveness of social influence and personality-targeted alcohol prevention on mental health outcomes among high-risk youth: A novel cluster randomised controlled factorial design trial.,"OBJECTIVE


This study examined the secondary mental health outcomes of two contrasting alcohol prevention approaches, whereby one intervention targets common underlying personality risk for alcohol use and mental health problems ( Preventure ) and the other targets alcohol- and drug-related behaviours and cognitions ( Climate Schools ).
METHODS


A 2 × 2 cluster randomised controlled factorial design trial was conducted in 26 Australian schools randomised to the following 4 conditions:  Climate Schools  ( n  = 6),  Preventure  ( n  = 7), combined  Climate Schools and Preventure  (CAP;  n  = 6) or treatment as usual (TAU;  n  = 7). Participants completed questionnaires at baseline, 6, 12, 24 and 36 months post-baseline including the Brief Symptom Inventory anxiety and depression scales and hyperactivity and conduct scales of the Strengths and Difficulties Questionnaire. Analyses focused on students who were at high-risk based on personality traits ( n  = 947; M age  = 13.3). The effectiveness of each approach in reducing symptoms of internalising and externalising problems was assessed using multi-level mixed effects analysis.
RESULTS


Main effects for each intervention relative to not receiving that intervention revealed significant main effects of  Preventure  in reducing anxiety symptoms ( d  = -0.27, 95% confidence interval [CI] = [-0.53, -0.01],  p  < 0.05) and a marginal effect in reducing depressive symptoms ( d  = -0.24, 95% CI = [-0.49, 0.01],  p  = 0.06) over 3 years. Interaction effects revealed that when delivered alone,  Preventure  significantly reduced conduct problems ( d  = -0.45, 95% CI = [-0.78, -0.11],  p  < 0.05) and hyperactivity symptoms ( d  = -0.38, 95% CI = [-0.70,-0.07],  p  < 0.05) compared to TAU.
CONCLUSION


This study is the first to report the effectiveness of personality-targeted alcohol prevention in reducing internalising and externalising symptoms relative to an active control, providing evidence in favour of its specificity in preventing concurrent substance use and mental health problems among high-risk youth.",2020,"RESULTS


Main effects for each intervention relative to not receiving that intervention revealed significant main effects of  Preventure  in reducing anxiety symptoms ( d  ","['high-risk youth', '26 Australian schools randomised to the following 4 conditions', 'students who were at high-risk based on personality traits ( n \u2009=\u2009947; M age \u2009=\u200913.3']","['social influence and personality-targeted alcohol prevention', 'personality-targeted alcohol prevention', 'Climate Schools  ( n \u2009=\u20096),  Preventure  ( n \u2009=\u20097), combined  Climate Schools and Preventure  (CAP;  n \u2009=\u20096) or treatment as usual (TAU;  n \u2009=\u20097']","['anxiety symptoms', 'conduct problems', 'symptoms of internalising and externalising problems', 'depressive symptoms', 'Brief Symptom Inventory anxiety and depression scales and hyperactivity and conduct scales of the Strengths and Difficulties Questionnaire', 'mental health outcomes', 'hyperactivity symptoms', 'Interaction effects']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",26.0,0.199119,"RESULTS


Main effects for each intervention relative to not receiving that intervention revealed significant main effects of  Preventure  in reducing anxiety symptoms ( d  ","[{'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lexine', 'Initials': 'L', 'LastName': 'Stapinski', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Barrett', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Birrell', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kelly', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Conrod', 'Affiliation': 'Department of Psychiatry, Université de Montréal, Montreal, QC, Canada.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867419877948']
1097,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.
METHODS


This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.
FINDINGS


Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.
INTERPRETATION


Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
FUNDING


Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1']
1098,31562059,"Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial.","BACKGROUND


Pneumonia is the leading cause of death among children globally. Most pneumonia deaths in low-income and middle-income countries (LMICs) occur among children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP) is considered a safe ventilation modality that might improve child pneumonia survival. bCPAP outcomes for high-risk African children with severe pneumonia are unknown. Since most child pneumonia hospitalisations in Africa occur in non-tertiary district hospitals without daily physician oversight, we aimed to examine whether bCPAP improves severe pneumonia mortality in such settings.
METHODS


This open-label, randomised, controlled trial was done in the general paediatric ward of Salima District Hospital, Malawi. We enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90%. Children were randomly assigned 1:1 to low-flow nasal cannula oxygen or nasal bCPAP. Non-physicians administered care; the primary outcome was hospital survival. Primary analyses were by intention-to-treat and interim and adverse events analyses per protocol. This trial is registered with ClinicalTrials.gov, number NCT02484183, and is closed.
FINDINGS


We screened 1712 children for eligibility between June 23, 2015, and March 21, 2018. The data safety and monitoring board stopped the trial for futility after 644 of the intended 900 participants were enrolled. 323 children were randomly assigned to oxygen and 321 to bCPAP. 35 (11%) of 323 children who received oxygen died in hospital, as did 53 (17%) of 321 who received bCPAP (relative risk 1·52; 95% CI 1·02-2·27; p=0·036). 13 oxygen and 17 bCPAP patients lacked hospital outcomes and were considered lost to follow-up. Suspected adverse events related to treatment occurred in 11 (3%) of 321 children receiving bCPAP and 1 (<1%) of 323 children receiving oxygen. Four bCPAP and one oxygen group deaths were classified as probable aspiration episodes, one bCPAP death as probable pneumothorax, and six non-death bCPAP events included skin breakdown around the nares.
INTERPRETATION


bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen. The use of bCPAP within certain patient populations and non-intensive care settings might carry risk that was not previously recognised. bCPAP in LMICs needs further evaluation before wider implementation for child pneumonia care.
FUNDING


Bill & Melinda Gates Foundation, International AIDS Society, Health Empowering Humanity.",2019,"INTERPRETATION


bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen.","['high-risk African children with severe pneumonia', '321 children receiving', '323 children', 'general paediatric ward of Salima District Hospital, Malawi', '1712 children for eligibility between June 23, 2015, and March 21, 2018', '323 children receiving oxygen', 'children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP', 'futility after 644 of the intended 900 participants were enrolled', 'children with high-risk conditions and severe pneumonia in Malawi', 'enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90']","['bCPAP', 'Bubble continuous positive airway pressure', 'low-flow nasal cannula oxygen or nasal bCPAP']","['hospital mortality', 'severe pneumonia mortality', 'hospital survival', 'intention-to-treat and interim and adverse events analyses per protocol', 'hospital outcomes', 'bCPAP outcomes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",900.0,0.254718,"INTERPRETATION


bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen.","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: emccoll3@jhmi.edu.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi; Department of Pediatrics, School of Medicine, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Makonokaya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Vaidya', 'Affiliation': 'BEAD Core, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Billioux', 'Affiliation': 'BEAD Core, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Chalira', 'Affiliation': 'Malawi Ministry of Heath, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Malawi Ministry of Heath, Lilongwe, Malawi.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Mofolo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi; Division of Infectious Disease, University of North Carolina at Chapel Hill, NC, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30243-7']
1099,32416073,"Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND


Patients with advanced or metastatic oesophageal squamous cell carcinoma have poor prognosis and few treatment options after first-line therapy. We aimed to assess efficacy and safety of the anti-PD-1 antibody camrelizumab versus investigator's choice of chemotherapy in previously treated patients.
METHODS


ESCORT is a randomised, open-label, phase 3 study of patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy. Patients were randomly assigned (1:1) to camrelizumab (200 mg every 2 weeks) or chemotherapy with docetaxel (75 mg/m 2  every 3 weeks) or irinotecan (180 mg/m 2  every 2 weeks), all given intravenously. Central randomisation was done using the Randomization and Trial Supply Management system with block size randomly generated as four or six and stratified by disease and ECOG performance status. The primary endpoint was overall survival, assessed in randomised patients who had received at least one dose of treatment. Safety was assessed in all treated patients. The trial is registered with ClinicalTrials.gov, NCT03099382, and is closed to new participants.
FINDINGS


From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients were randomly assigned to treatment, of whom 228 received camrelizumab treatment and 220 received chemotherapy. As of data cutoff on May 6, 2019, with a median follow-up time of 8·3 months (IQR 4·1-12·8) in the camrelizumab group and 6·2 months (3·6-10·1) in the chemotherapy group, median overall survival was 8·3 months (95% CI 6·8-9·7) in the camrelizumab group and 6·2 months (5·7-6·9) in the chemotherapy group (hazard ratio 0·71 [95% CI 0·57-0·87]; two-sided p=0·0010). The most common treatment-related adverse events of grade 3 or worse were anaemia (camrelizumab vs chemotherapy: six [3%] vs 11 [5%]), abnormal hepatic function (four [2%] vs one [<1%]), and diarrhoea (three [1%] vs nine [4%]). Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group. Ten treatment-related deaths occurred, seven (3%) in the camrelizumab group (three deaths from unknown causes, one enterocolitis, one hepatic function abnormal, one pneumonitis, and one myocarditis) and three (1%) in the chemotherapy group (two deaths from unknown causes, and one gastrointestinal haemorrhage).
INTERPRETATION


Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy, with a manageable safety profile. It might represent a potential option of standard second-line treatment for patients with oesophageal squamous cell carcinoma in China.
FUNDING


Jiangsu Hengrui Medicine.",2020,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","['Patients with advanced or metastatic oesophageal squamous cell carcinoma', 'Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy', 'From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients', 'advanced or metastatic oesophageal squamous cell carcinoma (ESCORT', 'patients with oesophageal squamous cell carcinoma in China', 'patients with advanced or metastatic oesophageal squamous cell carcinoma', 'patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China', 'previously treated patients']","['anti-PD-1 antibody camrelizumab', 'camrelizumab', 'chemotherapy with docetaxel', 'Camrelizumab', 'camrelizumab treatment and 220 received chemotherapy', 'chemotherapy', 'irinotecan']","['Safety', 'overall survival', 'diarrhoea', 'efficacy and safety', 'median overall survival', 'adverse events', 'deaths', 'abnormal hepatic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]",,0.242005,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Medical Oncology, Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Oncology Department, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zuoxing', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Internal Medicine Ward 4, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Oncology Department, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Oncology Center, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiotherapy, 900 Hospital of the Joint Logistics Team, Fuzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'The Oncology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xianbao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Department of Medical Oncology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Integrated Chinese and Western Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Medical Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30110-8']
1100,32416145,Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.,"OBJECTIVE


To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.
STUDY DESIGN


We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.
RESULTS


Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.
CONCLUSIONS


Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use.
IMPLICATIONS


A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.",2020,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"['Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy', 'healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups']","['contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate', '90-day contraceptive vaginal ring releasing estradiol and segesterone acetate', '2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information', 'segesterone acetate (SA']","['zero median unscheduled bleeding or spotting days', 'withdrawal bleeding', 'median E2 concentrations', 'Median serum E2 concentrations', 'serum estradiol (E2) concentrations', 'zero median unscheduled bleeding']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C4723383', 'cui_str': 'Segesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",65.0,0.194795,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mejchen@ucdavis.edu.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Reproductive Medicine Research, Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Health Decisions, Durham, NC, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}]",Contraception,['10.1016/j.contraception.2020.05.004']
1101,31561881,Comparison of the Level of Free Hexafluoro-isopropanol in Adults' Blood and the Incidence of Emergence Agitation After Anesthesia With Different Concentrations of Sevoflurane in Laparoscopic Gastrointestinal Surgery: A Randomized Controlled Clinical Trial.,"PURPOSE


The aim of the study is to compare the free hexafluoro-isopropanol (HFIP) concentration in adults' blood and the incidence of emergence agitation (EA) after inhaled different concentrations of sevoflurane.
METHODS


Sixty adult patients planning to undergo laparoscopic gastrointestinal surgery were randomly assigned to 3 groups. Each group received sevoflurane as the volatile anesthetic at different concentrations: 0.5 minimum alveolar concentration (MAC), 1.0 MAC, and 1.5 MAC. The use of sevoflurane was continued until the end of surgery. Venous blood samples were obtained at 30, 60, 120, and 180 minutes after starting the use of sevoflurane and subsequently at 60, 180, and 300 minutes after discontinuation of volatile anesthetic administration. Blood concentrations of sevoflurane and free HFIP were determined using gas chromatography. The recovery time and the incidence of EA at different time points were evaluated among the 3 groups.
FINDINGS


Changes in the blood concentrations of sevoflurane and free HFIP during and after the use of sevoflurane were similar in all 3 groups. The peak blood concentration of free HFIP occurred 60 minutes after onset of sevoflurane anesthesia in all 3 groups (P < 0.05). The lowest level of free HFIP and the longest recovery time were found in the 1.5-MAC group (P < 0.05). No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
IMPLICATIONS


The generation of HFIP would be inhibited when the inhaled sevoflurane concentration increased to 1.5 MAC. However, the incidence of EA during recovery had nothing to do with the inhaled different sevoflurane concentrations (within 1.5 MAC) in adults. ChicCTR.org identifier: ChiCTR-IPD-17011558.",2019,"No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
","['Sixty adult patients planning to undergo laparoscopic gastrointestinal surgery', 'Laparoscopic Gastrointestinal Surgery']","['1.5-MAC', 'sevoflurane', 'Sevoflurane', 'sevoflurane as the volatile anesthetic at different concentrations: 0.5 minimum alveolar concentration (MAC), 1.0 MAC, and 1.5 MAC']","['Emergence Agitation', 'lowest level of free HFIP and the longest recovery time', 'free hexafluoro-isopropanol (HFIP) concentration', 'Blood concentrations of sevoflurane and free HFIP', 'incidence of EA or moderate pain', 'inhaled sevoflurane concentration', 'Venous blood samples', 'peak blood concentration of free HFIP', 'blood concentrations of sevoflurane and free HFIP', 'recovery time and the incidence of EA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0524161', 'cui_str': 'Isopropanol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",60.0,0.0871735,"No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: 1017018674@qq.com.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: cxb64457@163.com.'}, {'ForeName': 'Wei-Guo', 'Initials': 'WG', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: 446717804@qq.com.'}, {'ForeName': 'San', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China. Electronic address: 380542247@qq.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Guangyuan Central Hospital, Guangyuan, Sichuan, China. Electronic address: 1076731619@qq.com.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China. Electronic address: yang_xl_yang@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.022']
1102,31296923,Association of post-operative CEA with survival and oxaliplatin benefit in patients with stage II colon cancer: a post hoc analysis of the MOSAIC trial.,"BACKGROUND


Adjuvant treatment for stage II colon cancer (CC) can be proposed to patients with high-risk disease. Recently, 2.35 ng/mL carcinoembryonic antigen (CEA) was identified as the best cut-off value. This post hoc analysis of the MOSAIC trial assessed post-operative CEA prognostic value for survival outcomes and predictive value for the addition of oxaliplatin to adjuvant treatment.
METHODS


Prognostic and predictive values of post-operative CEA in patients with stage II CC were evaluated with Kaplan-Meier survival curves and Cox model with interaction terms. Disease-free survival (DFS) and overall survival (OS) were estimated.
RESULTS


Among 899 stage II CC patients, post-operative CEA was available in 867 (96.4%); and 434 (48.65%) had a high-risk stage II disease. The 3-year DFS rate was 88.5% and 78.7% in the ≤ 2.35 ng/mL and > 2.35 ng/mL group, respectively (P = 0.006). Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
CONCLUSION


CEA is a strong prognostic factor for DFS and OS in stage II CC. In the MOSAIC trial, only high-risk stage II CC patients with post-operative CEA > 2.35 ng/mL benefited from the addition of oxaliplatin to LV5FU2.
TRIAL REGISTRATION


NCT00275210 (January 11, 2006).",2019,"Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
","['patients with high-risk disease', 'patients with stage II CC', 'patients with stage II colon cancer', 'stage II colon cancer (CC']","['oxaliplatin', 'CEA']","['3-year DFS rate', 'Disease-free survival (DFS) and overall survival (OS', 'post-operative CEA', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.250109,"Use of oxaliplatin showed survival benefit only in patients with high-risk stage II CC and post-operative CEA > 2.35 ng/ml (interaction term P = 0.09 and 0.03 for DFS and OS).
","[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Auclin', 'Affiliation': 'Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Sorbonne Paris-Cité, Paris Descartes University, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Sorbonne University, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Hepato-Gastroenterology and Gastrointestinal Oncology, Sorbonne Paris-Cité, Paris Descartes University, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Unit of Medical Oncology, Clinical Cancer Center, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'Department of Gastroenterology and Digestive diseases, Hopital Erasme, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), CIBERONC, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Department of Oncology, Royal Bournemouth Hospital and Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'Aimery', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': 'Oncology Multidisciplinary Research Group (GERCOR), Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France. dvernerey@chu-besancon.fr.'}]",British journal of cancer,['10.1038/s41416-019-0521-7']
1103,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
1104,31554422,Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial.,"BACKGROUND


Recent trials suggest that complete revascularization in patients with acute ST-segment-elevation myocardial infarction and multivessel disease is associated with better outcomes than infarct-related artery (IRA)-only revascularization. There are different methods to select non-IRA lesions for revascularization procedures. We assessed the clinical outcomes of complete angiographically guided revascularization versus stress echocardiography-guided revascularization in patients with ST-segment-elevation myocardial infarction.
METHODS


We performed a randomized clinical trial in patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or stress echocardiography-guided revascularization (n=152) of the non-IRA lesions in an elective procedure before hospital discharge.
RESULTS


The trial was prematurely stopped after the inclusion of 77% of the planned study population. As many as 152 (99%) patients in the complete revascularization group and 44 (29%) patients in the selective revascularization group required a percutaneous coronary intervention procedure of a non-IRA lesion before discharge. The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72;  P =0.85).
CONCLUSIONS


In patients with ST-segment-elevation myocardial infarction and multivessel disease, stress echocardiography-guided revascularization may not be significantly different to complete angiographically guided revascularization, thereby reducing the need for elective revascularization before hospital discharge.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01179126.",2019,"The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72;  P =0.85).
","['Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease', 'patients with acute ST-segment-elevation myocardial infarction and multivessel disease', 'patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or', 'patients with ST-segment-elevation myocardial infarction and multivessel disease', 'n=152) of the non-IRA lesions in an elective procedure before hospital discharge', 'patients with ST-segment-elevation myocardial infarction']","['Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization', 'stress echocardiography-guided revascularization', 'complete angiographically guided revascularization versus stress echocardiography-guided revascularization']",['percutaneous coronary intervention procedure of a non-IRA lesion'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0920208', 'cui_str': 'Echocardiography, Stress'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.0880571,"The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72;  P =0.85).
","[{'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Calviño-Santos', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Estévez-Loureiro', 'Affiliation': 'Department of Cardiology, Hospital Alvaro Cunqueiro, Vigo, Spain (R.E.-L.).'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Peteiro-Vázquez', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salgado-Fernández', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodríguez-Vilela', 'Affiliation': 'Department of Cardiology, Hospital Universitario Arquitecto Marcide, Ferrol, Spain (A.R.-V., A.M.-P.).'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Department of Cardiology, Hospital Universitario Lucus Augusti, Lugo, Spain (R.F.-G., C.G.-J.).'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bouzas-Mosquera', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'José Ángel', 'Initials': 'JÁ', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mesías-Prego', 'Affiliation': 'Department of Cardiology, Hospital Universitario Arquitecto Marcide, Ferrol, Spain (A.R.-V., A.M.-P.).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González-Juanatey', 'Affiliation': 'Department of Cardiology, Hospital Universitario Lucus Augusti, Lugo, Spain (R.F.-G., C.G.-J.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Aldama-López', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Piñón-Esteban', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Xacobe', 'Initials': 'X', 'LastName': 'Flores-Ríos', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Soler-Martín', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Seoane-Pillado', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Vázquez-González', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muñiz', 'Affiliation': 'CIBERCV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Instituto de Salud Carlos III, Madrid, Spain (J.P.-V., J.S.-F., A.B.-M., N.V.-G., J.M., J.M.V.-R.).'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vázquez-Rodríguez', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.007924']
1105,31554423,Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices.,"BACKGROUND


Ticagrelor reduced the rate of myocardial infarction and death compared with clopidogrel in patients with acute coronary syndrome. However, little is understood about chronic treatment of ticagrelor on microvascular dysfunction. The objective of this study was to assess the impact of ticagrelor maintenance treatment on microvascular system and coronary flow in comparison with clopidogrel.
METHODS


This study was a nonblinded, open-label, parallel-group, prospective, randomized controlled trial that enrolled 120 patients with acute coronary syndrome requiring stent implantation. Patients were randomized into the ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) group. The primary end point was coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR) at 6 months after treatment.
RESULTS


The baseline clinical characteristics and physiological parameters, such as fractional flow reserve, coronary flow reserve, and IMR, did not differ between the ticagrelor and clopidogrel groups. Six-month follow-up physiological data showed that the IMR value was significantly lower in the ticagrelor group than the clopidogrel group (15.57±5.65 versus 21.15±8.39,  P <0.01), and coronary flow reserve was higher in the ticagrelor group than in the clopidogrel group (3.85±0.72 versus 3.37±0.76,  P <0.01). However, there was no difference in fractional flow reserve (0.87±0.08 versus 0.87±0.09,  P =0.94) between the 2 groups. The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01). Analyses of 223 nonculprit vessels of registered patients based on physiological results showed no differences in baseline fractional flow reserve (0.93±0.13 versus 0.92±0.09,  P =0.58), coronary flow reserve (3.62±1.27 versus 3.51±1.24,  P =0.16), or IMR (21.37±12.37 versus 24.19±21.08,  P =0.22) or in follow-up fractional flow reserve (0.91±0.09 versus 0.91±0.08,  P =0.67), coronary flow reserve (3.91±1.22 versus 3.75±1.16,  P =0.36), or IMR (19.43±10.32 versus 21.52±18.90,  P =0.34) between the 2 groups.
CONCLUSIONS


Compared with clopidogrel, 6 months of ticagrelor therapy significantly improved microvascular dysfunction in acute coronary syndrome patients with stent implantation.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02618733.",2019,The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01).,"['patients with acute coronary syndrome', 'Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices', 'acute coronary syndrome patients with stent implantation', 'enrolled 120 patients with acute coronary syndrome requiring stent implantation']","['clopidogrel', 'Ticagrelor and Clopidogrel', 'Ticagrelor', 'ticagrelor therapy', 'ticagrelor', 'ticagrelor maintenance treatment']","['microvascular dysfunction', 'fractional flow reserve', 'IMR value', 'Microvascular Dysfunction', 'microvascular system and coronary flow', 'IMR', 'fractional flow reserve, coronary flow reserve, and IMR', 'coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR', 'baseline fractional flow reserve', 'rate of myocardial infarction and death', 'coronary flow reserve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.0511629,The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01).,"[{'ForeName': 'Kyungil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Young-Rak', 'Initials': 'YR', 'LastName': 'Cho', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Jong-Sung', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Moo-Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Young-Dae', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008105']
1106,31537473,"Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial.","BACKGROUND


Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis.
METHODS


We did a randomised, controlled, phase 2-3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen-A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6-8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15.
FINDINGS


Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210-262) in the hyperbaric oxygen therapy group and 217 days (195-237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2-18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
INTERPRETATION


Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment.
FUNDING


The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.",2019,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","['n=42) or standard care (n=45', 'group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group', 'All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion', '223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients', 'five Nordic university hospitals']","['hyperbaric oxygen therapy', 'hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions', 'Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART', 'RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen', 'radiotherapy']","['symptoms of late radiation cystitis', 'Symptoms of late radiation cystitis', 'Expanded Prostate Index Composite Score (EPIC', 'Median time', 'transient grade 1-2 adverse events, related to sight and hearing', 'change in patient-perceived urinary symptoms assessed with EPIC', 'EPIC urinary total score', 'absolute change in EPIC urinary total score']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0436385', 'cui_str': 'Radiotherapy completed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",79.0,0.156227,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Oscarsson', 'Affiliation': 'Angereds Närsjukhus, Angered, Sweden; Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden. Electronic address: nicklas.oscarsson@vgregion.se.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Rosén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Lodding', 'Affiliation': 'Department of Urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mölne', 'Affiliation': 'Department of Pathology and Genetics, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giglio', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Hjelle', 'Affiliation': 'Department of Urology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Vaagbø', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hyldegaard', 'Affiliation': 'Department of Anaesthesia and Surgery, Hyperbaric Unit, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vangedal', 'Affiliation': 'Department of Urology, Herlev-Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Salling', 'Affiliation': 'Department of Urology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kjellberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Lind', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anaesthesiology and Intensive Care Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Ettala', 'Affiliation': 'Department of Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Arola', 'Affiliation': 'Department of Anaesthesiology and Intensive, University of Turku, Turku, Finland.'}, {'ForeName': 'Helén', 'Initials': 'H', 'LastName': 'Seeman-Lodding', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30494-2']
1107,31742467,Evaluating the Framed Portrait Experience as an Intervention to Enhance Self-Efficacy and Self-Esteem in a Sample of Adolescent and Young Adult Cancer Survivors: Results of a Pilot Study.,"Cancer diagnosis and treatments negatively affect quality of life and developmental processes of adolescents and young adults (AYAs), with self-esteem, self-efficacy, and body image discomfort reported. Despite increasing awareness of the psychosocial issues experienced by this group, a paucity of psychosocial interventions has been developed. This study aims to investigate the Framed Portrait Experience (FPE) as an intervention to promote well-being among AYA cancer survivors. A pilot study was conducted using a quasi-experimental design. The sample included 18 AYA leukemia survivors. Individuals in the intervention group ( n  = 10) participated in the FPE, a psychosocial program consisting of two sessions. In the first one, starting from the illness narrative recollected by the individual, pictures representing the subject in meaningful contexts are taken. Then, a selected number of pictures are used in a second encounter with a therapist to integrate the disease within past, present, and future of the participant. Survivors in the comparison group ( n  = 8) were offered usual psychosocial care at the participating institute. Measures of personality traits, coping, self-efficacy, self-esteem, and body image were compared at pre-test and 3 months later. Significant differences in self-efficacy and self-esteem scores were identified at post-test between the intervention and comparison group ( p  < 0.05). No significant differences were identified for body self-esteem. These findings provide initial evidence supporting the FPE as a low-cost and easy-to-implement intervention to promote self-efficacy and self-esteem among AYA survivors. Further research with larger samples, with more rigorous designs, and different cancer types is needed.",2020,Significant differences in self-efficacy and self-esteem scores were identified at post-test between the intervention and comparison group ( p  < 0.05).,"['adolescents and young adults (AYAs', 'Adolescent and Young Adult Cancer Survivors']",['Framed Portrait Experience (FPE'],"['body self-esteem', 'self-efficacy and self-esteem scores', 'personality traits, coping, self-efficacy, self-esteem, and body image', 'quality of life and developmental processes', 'Self-Efficacy and Self-Esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0376644', 'cui_str': 'Portrait'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0034380'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.0173966,Significant differences in self-efficacy and self-esteem scores were identified at post-test between the intervention and comparison group ( p  < 0.05).,"[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Saita', 'Affiliation': 'Department of Psychology, Università Cattolica del Sacro Cuore, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Acquati', 'Affiliation': 'Graduate College of Social Work, University of Houston, Houston, Texas.'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2019.0063']
1108,30792364,Stepped care programme in primary care to prevent anxiety and depression: a randomised clinical trial.,,2019,,[],['Stepped care programme'],['anxiety and depression'],[],"[{'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.108604,,"[{'ForeName': 'S Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'W W S', 'Initials': 'WWS', 'LastName': 'Mak', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'F M C', 'Initials': 'FMC', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mercer', 'Affiliation': 'General Practice and Primary Care, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Griffiths', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'D T F', 'Initials': 'DTF', 'LastName': 'Lee', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kung', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Lam', 'Affiliation': 'New Territories East Cluster, Hospital Authority, Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1109,30843186,Choosing between continuing vitamin K antagonists (VKA) or switching to a direct oral anticoagulant in currently well-controlled patients on VKA for atrial fibrillation: a randomised controlled trial (GAInN).,,2019,,[],['vitamin K antagonists (VKA'],[],[],"[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]",[],,0.0505035,,"[{'ForeName': 'Jasper H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hilde A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Westerterp', 'Affiliation': 'Certe Thrombosis Service Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}]",British journal of haematology,['10.1111/bjh.15856']
1110,30760066,Inference on covariate effect types for treatment effectiveness in a randomized trial with a binary outcome.,"BACKGROUND/AIMS


Some randomized clinical trials seek to establish covariate effect types that indicate whether a covariate is predictive and/or prognostic, in addition to endpoint evaluation. Here, for a case with a binary outcome, we propose that the covariate effect type should be assessed in terms of four types of potential responses: activated- (always-), inert- (never-), causative-, and preventive-responder.
METHODS


We introduce a new concept of covariate effect types differing from the commonly used ""prediction"" and ""prognosis."" We summarize the covariate effect types by inspecting the proportions of subjects in each response type in two subgroups of a covariate, and indicate whether the fractions are augmented, depleted, or neutral as one changes the level of the covariate. Although these proportions cannot generally be identified, we can derive the posterior distributions of the proportions by applying a recently developed Bayesian method. On the basis of the distributions, we would say that the covariate is ""augmented-causative"" if the difference between the proportions of causative-responders (who would respond if they received the treatment but would not if they did not) in two subgroups is positive, rather than that it is predictive. Similarly, we would say that the covariate is ""neutral-activated"" if the difference in the proportion of activated-responders (who would respond regardless of their randomized treatment assignment) is close to zero, rather than saying that the covariate is not prognostic. We further describe the relationship between our approach and standard subgroup analysis.
RESULTS


We applied our approach to data from a randomized clinical trial comparing nivolumab and docetaxel for subjects with advanced nonsquamous non-small-cell lung cancer; we assessed the covariate effect type of PD-L1 status, where PD-L1 is a ligand of the programmed death 1 (PD-1) receptor expressed by activated T cells. When the endpoint was the overall response rate, the posterior distributions for the differences between the proportions of subjects in response types in the PD-L1-positive and negative subgroups yielded an expected-a-posteriori estimate of 0.243 (95% credible interval (CI): 0.094, 0.374) for causative-responders and 0.014 (95% CI: -0.087, 0.125) for activated-responders. Thus, PD-L1 status was augmented-causative for nivolumab effectiveness, to an extent of 24.3%, and was neutral-activated.
CONCLUSION


Our approach characterizes the covariate effect types in terms of the response types, and to what extent. In a randomized clinical trial with a binary outcome, our approach is a potentially valuable addition to standard subgroup or regression analysis.",2019,"In a randomized clinical trial with a binary outcome, our approach is a potentially valuable addition to standard subgroup or regression analysis.",['subjects with advanced nonsquamous non-small-cell lung cancer'],['nivolumab and docetaxel'],['overall response rate'],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.119841,"In a randomized clinical trial with a binary outcome, our approach is a potentially valuable addition to standard subgroup or regression analysis.","[{'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Clinical Research Center, Kinki University Hospital, Osakasayama, Japan.'}]","Clinical trials (London, England)",['10.1177/1740774519828301']
1111,31553463,Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial.,"Importance


Laparoscopic distal gastrectomy and neoadjuvant chemotherapy are increasingly used to treat locally advanced gastric cancer. However, the safety and efficacy of the laparoscopic procedure after neoadjuvant chemotherapy remain unclear.
Objective


To evaluate the short-term outcomes of patients with locally advanced gastric cancer who received either laparoscopic distal gastrectomy or open distal gastrectomy.
Design, Setting, and Participants


Between April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China. Patients (n = 96) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving neoadjuvant chemotherapy were enrolled and randomized. An as-treated population and a modified intention-to-treat (mITT) population were defined for the data analysis.
Interventions


Patients were randomized to undergo either laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy.
Main Outcomes and Measures


The primary end point was 3-year recurrence-free survival rate. Secondary end points were surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status.
Results


In total, 95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR)] age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses (LADG: 47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years). In the as-treated analyses, the LADG group had a significantly lower postoperative complication rate than the ODG group (20% vs 46%; P = .007). The postoperative visual analog scale score for pain was 1.2 units lower on postoperative day 2 only in the LADG group (95% CI, -2.1 to -0.3; P = .008). Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%]; P = .04). The mITT analyses showed similar results to as-treated analyses.
Conclusions and Relevance


This trial found that LADG appears to offer the benefits of better postoperative safety and adjuvant chemotherapy tolerance compared with ODG for patients with locally advanced gastric cancer who received neoadjuvant chemotherapy.
Trial Registration


ClinicalTrials.gov identifier: NCT02404753.",2019,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","['patients with locally advanced gastric cancer who received either', 'age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses', '47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years', 'Participants\n\n\nBetween April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China', 'locally advanced gastric cancer', 'Patients (n\u2009=\u200996) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving', '95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR', 'Locally Advanced Gastric Cancer', 'patients with locally advanced gastric cancer who received neoadjuvant chemotherapy']","['ODG', 'laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy', 'LADG', 'Laparoscopic Distal Gastrectomy', 'neoadjuvant chemotherapy', 'laparoscopic distal gastrectomy or open distal gastrectomy', 'Laparoscopic distal gastrectomy and neoadjuvant chemotherapy', 'Neoadjuvant Chemotherapy']","['adverse effects', 'postoperative complication rate', 'adjuvant chemotherapy completion', '3-year recurrence-free survival rate', 'surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status', 'postoperative visual analog scale score for pain', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",95.0,0.25282,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","[{'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shan', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangji', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'E', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Yinkui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jiafu', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.3473']
1112,31559463,Acute ACL reconstruction shows superior clinical results and can be performed safely without an increased risk of developing arthrofibrosis.,"PURPOSE


To compare acute ACL reconstruction (ACLR) within 8 days of injury with delayed reconstruction after normalized range of motion (ROM), 6-10 weeks after injury. It was hypothesized that acute ACL reconstruction with modern techniques is safe and can be beneficial in terms of patient-reported outcomes and range of motion.
METHODS


The effect of acute and delayed ACLR was randomized studied on 70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013. Patient-reported outcomes, objective IKDC, KOOS, and manual stability measurements were documented during the 24-month follow-up period.
RESULTS


The acute ACLR group did not result in increased stiffness and showed superior outcome regarding strength and how the patient felt their knee functioning at 24 months. In addition, the acute group was not inferior to the delayed group in any assessment. Regarding patient-related outcomes in KOOS, both groups showed significant improvements in all subscales, but no difference was found between the groups. Functional return (FR) rate was almost double compared to the Swedish knee ligament register and treatment failure (TF) rate was reduced by half, no significant difference between the groups. No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
CONCLUSION


Acute ACLR within 8 days of injury does not appear to adversely affect ROM or result in increased stiffness in the knee joint and was not inferior to the delayed group in any assessment when compared to delayed surgery.
LEVEL OF EVIDENCE


I.",2020,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","['70 patients with high recreational activity level, Tegner level 6 or more, between 2006 and 2013']",['acute ACL reconstruction (ACLR'],"['Functional return (FR) rate', 'Swedish knee ligament register and treatment failure (TF) rate', 'cyclops removal, re-injury of ACL or meniscus', 'objective IKDC, KOOS, and manual stability measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0162643'}, {'cui': 'C1578615', 'cui_str': 'Cyclops'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.053596,"No difference regarding cyclops removal, re-injury of ACL or meniscus was found between the two surgical timing groups.
","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'von Essen', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden. Christoffer.vonessen@gmail.com.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Barenius', 'Affiliation': 'Department of Orthopaedics, Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05722-w']
1113,26656481,Health Selection into Neighborhoods Among Families in the Moving to Opportunity Program.,"Moving to Opportunity for Fair Housing was a randomized experiment that moved very low-income US families from high-poverty neighborhoods to low-poverty neighborhoods starting in the early 1990s. We modeled report of a child's baseline health problem as a predictor of neighborhood outcomes for households randomly assigned to move from high- to low-poverty neighborhoods. We explored associations between baseline health problems and odds of moving with the program upon randomization (1994-1997), neighborhood poverty rate at follow-up (2002), and total time spent in affluent neighborhoods and duration-weighted poverty. Among 1,550 households randomized to low-poverty neighborhoods, a smaller share of households reporting baseline child health problems (P = 0.004) took up the intervention (38%) than those not reporting a health problem (50%). In weighted and covariate-adjusted models, a child health problem predicted nearly 40% lower odds of complying with the experimental condition (odds ratio = 0.62, 95% confidence interval: 0.42, 0.91; P = 0.015). Among compliers, a baseline child health problem predicted 2.5 percentage points' higher neighborhood poverty at take-up (95% confidence interval: 0.90, 4.07; P = 0.002). We conclude that child health problems in a household prior to randomization predicted lower likelihood of using the program voucher to move to a low-poverty neighborhood within the experiment's low-poverty treatment arm and predicted selection into poorer neighborhoods among experimental compliers. Child morbidity may constrain families attempting to improve their life circumstances.",2016,"Among compliers, a baseline child health problem predicted 2.5 percentage points' higher neighborhood poverty at take-up (95% confidence interval: 0.90, 4.07; P = 0.002).","['1,550 households randomized to low-poverty neighborhoods, a smaller share of households reporting baseline child health problems (P = 0.004) took up the intervention (38%) than those not reporting a health problem (50', 'households randomly assigned to move from high- to low-poverty neighborhoods']",[],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1269909', 'cui_str': 'MOVED FROM (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],[],1550.0,0.049764,"Among compliers, a baseline child health problem predicted 2.5 percentage points' higher neighborhood poverty at take-up (95% confidence interval: 0.90, 4.07; P = 0.002).","[{'ForeName': 'Mariana C', 'Initials': 'MC', 'LastName': 'Arcaya', 'Affiliation': ''}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Graif', 'Affiliation': ''}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Waters', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Subramanian', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwv189']
1114,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND


No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS


Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS


The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION


No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
1115,32418801,Primary Care Cluster RCT to Increase Diabetes Prevention Program Referrals.,"INTRODUCTION


The Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.
STUDY DESIGN


A pragmatic, cluster randomized, mixed-methods study.
SETTING/PARTICPANTS


Clusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.
INTERVENTION


Implementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.
MAIN OUTCOME MEASURES


The primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.
RESULTS


Study clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.
CONCLUSIONS


Intervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.",2020,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","['Diabetes Prevention Program referrals at a primary care clinic', 'Clusters were teams of primary care clinicians from 2 primary care clinics', '2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4']",[],['referral of patients with prediabetes to the institutional Diabetes Prevention Program'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",2992.0,0.0201638,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Keck', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky; Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky. Electronic address: james.keck@uky.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Roper', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Hieronymus', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky; University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Alisha R', 'Initials': 'AR', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Fowlkes', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.008']
1116,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND


Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
METHODS


Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
RESULTS


188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021']
1117,30776324,"Cognitive Behavioral Treatment for Acute Posttrauma Distress: A Randomized, Controlled Proof-of-Concept Study Among Hospitalized Adults With Burns.","OBJECTIVE


(1) To evaluate the feasibility of conducting a randomized controlled trial (RCT) of the Safety, Meaning, Activation and Resilience Training (SMART) intervention vs nondirective supportive psychotherapy (NDSP) in an acutely hospitalized adult survivor of burn injury sample; and (2) to assess the preliminary effect of SMART on acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and major depressive disorder (MDD) symptom reduction as secondary prevention.
DESIGN


Proof-of-concept, parallel group RCT design.
SETTING


Regional burn center.
PARTICIPANTS


Acutely injured, hospitalized adult survivors of burn injury (N=50) were randomly assigned to SMART (n=28) or nondirective supportive psychotherapy (n=22). Due to dropout and missing data, final sample size was 40, SMART (n=21) and nondirective supportive psychotherapy (n=19).
INTERVENTIONS


SMART is a manualized, 4-session cognitive behavioral therapy-based psychological intervention targeting ASD, PTSD, and MDD symptoms. NDSP is a manualized, 4-session protocol.
MAIN OUTCOME MEASURES


Davidson Trauma Scale ([DTS]; diagnostic proxy for ASD and PTSD; clinical cutoff=40, with higher score=higher severity) and the Patient Health Questionnaire-9 ([PHQ-9]; diagnostic proxy for MDD; clinical cutoff=10, with higher score=higher severity) at pretreatment, immediate posttreatment, and 1 month posttreatment.
RESULTS


At baseline, median DTS scores and PHQ-9 scores were above clinical cutoffs and did not differ across groups. At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points.
CONCLUSIONS


It is feasible to conduct an RCT of SMART in hospitalized adult survivors of burn injury. SMART has the potential to yield clinically significant outcomes. Additional studies are needed to replicate and extend these findings.",2020,"At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points.
","['Hospitalized Adults With Burns', 'hospitalized adult survivors of burn injury', 'Regional burn center', 'Acute Posttrauma Distress', 'Acutely injured, hospitalized adult survivors of burn injury (N=50', 'acutely hospitalized adult survivor of burn injury sample']","['Meaning, Activation and Resilience Training (SMART) intervention vs nondirective supportive psychotherapy (NDSP', 'NDSP', 'SMART', 'Cognitive Behavioral Treatment', 'nondirective supportive psychotherapy']","['median DTS and PHQ-9 scores', 'Davidson Trauma Scale ([DTS]; diagnostic proxy for ASD and PTSD', 'acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and major depressive disorder (MDD) symptom reduction', 'median DTS scores and PHQ-9 scores', 'Patient Health Questionnaire-9']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006418', 'cui_str': 'Burn Centers'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0222045'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0236816', 'cui_str': 'Stress Disorders, Acute'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",50.0,0.0801417,"At 1 week and 1 month posttreatment, median DTS and PHQ-9 scores were beneath clinical cutoffs in the SMART group; scores remained above clinical cutoffs in the NDSP group at these time points.
","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Fauerbach', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: jfauerb1@jhmi.edu.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gehrke', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Shawn T', 'Initials': 'ST', 'LastName': 'Mason', 'Affiliation': 'Johnson and Johnson Health and Wellness Solutions, New Brunswick, New Jersey.'}, {'ForeName': 'Neda F', 'Initials': 'NF', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Milner', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Surgery, Division of Plastics and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Caffrey', 'Affiliation': 'Johns Hopkins Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; Department of Surgery, Division of Plastics and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2018.11.027']
1118,30940047,Measuring the effects of listening for leisure on outcome after stroke (MELLO): A pilot randomized controlled trial of mindful music listening.,"BACKGROUND


Cognitive deficits and low mood are common post-stroke. Music listening is suggested to have beneficial effects on cognition, while mindfulness may improve mood. Combining these approaches may enhance cognitive recovery and improve mood early post-stroke.
AIMS


To assess the feasibility and acceptability of a novel mindful music listening intervention.
METHODS


A parallel group randomized controlled feasibility trial with ischemic stroke patients, comparing three groups; mindful music listening, music listening and audiobook listening (control group), eight weeks intervention. Feasibility was measured using adherence to protocol and questionnaires. Cognition (including measures of verbal memory and attention) and mood (Hospital Anxiety and Depression Scale) were assessed at baseline, end of intervention and at six-months post-stroke.
RESULTS


Seventy-two participants were randomized to mindful music listening ( n  = 23), music listening ( n  = 24), or audiobook listening ( n  = 25). Feasibility and acceptability measures were encouraging: 94% fully consistent with protocol; 68.1% completing ≥6/8 treatment visits; 80-107% listening adherence; 83% retention to six-month endpoint. Treatment effect sizes for cognition at six month follow-up ranged from d = 0.00 ([-0.64,0.64], music alone), d = 0.31, ([0.36,0.97], mindful music) for list learning; to d = 0.58 ([0.06,1.11], music alone), d = 0.51 ([-0.07,1.09], mindful music) for immediate story recall; and d = 0.67 ([0.12,1.22], music alone), d = 0.77 ([0.16,1.38]mindful music) for attentional switching compared to audiobooks. No signal of change was seen for mood. A definitive study would require 306 participants to detect a clinically substantial difference in improvement (z-score difference = 0.66,  p  = 0.017, 80% power) in verbal memory (delayed story recall).
CONCLUSIONS


Mindful music listening is feasible and acceptable post-stroke. Music listening interventions appear to be a promising approach to improving recovery from stroke.",2020,"Cognition (including measures of verbal memory and attention) and mood (Hospital Anxiety and Depression Scale) were assessed at baseline, end of intervention and at six-months post-stroke.
","['Seventy-two participants', 'ischemic stroke patients']","['music listening', 'mindful music listening, music listening and audiobook listening (control group), eight weeks intervention', 'mindful music listening', 'novel mindful music listening intervention', 'Music listening interventions', 'audiobook listening', 'Music listening']","['Feasibility and acceptability measures', 'verbal memory (delayed story recall', 'Cognition (including measures of verbal memory and attention) and mood (Hospital Anxiety and Depression Scale', 'feasibility and acceptability']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}]",72.0,0.218213,"Cognition (including measures of verbal memory and attention) and mood (Hospital Anxiety and Depression Scale) were assessed at baseline, end of intervention and at six-months post-stroke.
","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Baylan', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Haig', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'MacDonald', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Stiles', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Easto', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Meigan', 'Initials': 'M', 'LastName': 'Thomson', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Cullen', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'Mercer', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Niall M', 'Initials': 'NM', 'LastName': 'Broomfield', 'Affiliation': 'Stroke Psychology Service, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Murray', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Evans', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019841250']
1119,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht  Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht  Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413']
1120,32419117,Emotion Regulation among Children in Foster Care Versus Birth Parent Care: Differential Effects of an Early Home-Visiting Intervention.,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning. The current study uses two randomized control trials, one conducted with foster caregivers and one conducted with birth parents, to investigate the longitudinal effects of caregiver type (foster versus birth parent) and a home-visiting parenting intervention on emotion regulation among young children referred to CPS. Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care. Caregivers were randomly assigned to receive Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention. Caregiver type moderated the effects of ABC on young children's observed anger dysregulation during a frustrating task at age 2 to 3 years. Among children remaining with their birth parents, children whose caregivers received ABC showed lower anger dysregulation than children whose caregivers received the control intervention. Children placed in foster care showed lower anger dysregulation than children with birth parents regardless of parenting intervention, and additionally showed higher adaptive regulation than children remaining with their birth parents. Adaptive regulation was not significantly associated with parenting intervention or the caregiver by intervention interaction. Results suggest that foster care placement may be protective for emerging emotion regulation skills among young children referred to CPS, and an attachment-based parenting intervention buffers risks of remaining in the home for young children's emotion dysregulation.",2020,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","['young children', 'children remaining with their birth parents', 'young children referred to CPS', 'Versus Birth Parent Care', 'Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care', 'foster caregivers and one conducted with birth parents', 'Children in Foster Care']","['Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention', 'ABC', 'Child Protective Services (CPS', 'Early Home-Visiting Intervention', 'caregiver type (foster versus birth parent) and a home-visiting parenting intervention']","['emotion regulation skills', 'anger dysregulation', 'Emotion Regulation', 'adaptive regulation', 'Adaptive regulation']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3178496', 'cui_str': 'AM 211'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",211.0,0.0309807,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","[{'ForeName': 'Madelyn H', 'Initials': 'MH', 'LastName': 'Labella', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA. mlabella@udel.edu.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Sellers', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Caroline K P', 'Initials': 'CKP', 'LastName': 'Roben', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00653-4']
1121,31983369,Psychoeducational Interventions for Problematic Anger in Chronic Moderate to Severe Traumatic Brain Injury: A Study of Treatment Enactment.,"OBJECTIVES


Treatment enactment, a final stage of treatment implementation, refers to patients' application of skills and concepts from treatment sessions into everyday life situations. We examined treatment enactment in a two-arm, multicenter trial comparing two psychoeducational treatments for persons with chronic moderate to severe traumatic brain injury and problematic anger.
METHODS


Seventy-one of 90 participants from the parent trial underwent a telephone enactment interview at least 2 months (median 97 days, range 64-586 days) after cessation of treatment. Enactment, quantified as average frequency of use across seven core treatment components, was compared across treatment arms: anger self-management training (ASMT) and personal readjustment and education (PRE), a structurally equivalent control. Components were also rated for helpfulness when used. Predictors of, and barriers to, enactment were explored.
RESULTS


More than 80% of participants reported remembering all seven treatment components when queried using a recognition format. Enactment was equivalent across treatments. Most used/most helpful components concerned normalizing anger and general anger management strategies (ASMT), and normalizing traumatic brain injury-related changes while providing hope for improvement (PRE). Higher baseline executive function and IQ were predictive of better enactment, as well as better episodic memory (trend). Poor memory was cited by many participants as a barrier to enactment, as was the reaction of other people to attempted use of strategies.
CONCLUSIONS


Treatment enactment is a neglected component of implementation in neuropsychological clinical trials, but is important both to measure and to help participants achieve sustained carryover of core treatment ingredients and learned material to everyday life.",2020,"Higher baseline executive function and IQ were predictive of better enactment, as well as better episodic memory (trend).","['persons with chronic moderate to severe traumatic brain injury and problematic anger', 'Seventy-one of 90 participants from the parent trial underwent a', 'Chronic Moderate to Severe Traumatic Brain Injury']","['telephone enactment interview', 'Psychoeducational Interventions']",[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],,0.0383913,"Higher baseline executive function and IQ were predictive of better enactment, as well as better episodic memory (trend).","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Hart', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA 19027, USA.'}, {'ForeName': 'Monica J', 'Initials': 'MJ', 'LastName': 'Vaccaro', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA 19027, USA.'}, {'ForeName': 'Jesse R', 'Initials': 'JR', 'LastName': 'Fann', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Roland D', 'Initials': 'RD', 'LastName': 'Maiuro', 'Affiliation': 'Private Practice, Seattle, WA, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Neuberger', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA 19027, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sinfield', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, PA 19129, USA.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000833']
1122,32420649,Comparison of vortioxetine and sertraline for treatment of major depressive disorder in elderly patients: A double-blind randomized trial.,"WHAT IS KNOWN AND OBJECTIVE


Major depressive disorder (MDD) is a complex disease and one of the leading contributors to disease burden throughout the world. In the current study, we explored the efficacy and tolerability of vortioxetine versus sertraline on symptoms of depression in elderly patients with MDD.
METHODS


Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were entered into a randomized double-blind study and were randomized to receive either vortioxetine (15 mg daily) or sertraline (75 mg daily) for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 3 and 6. Changes in HAM-D score, response rates, remission rate and time to response or remission were also compared between the two study groups.
RESULTS AND DISCUSSION


Fifty patients completed the trial after six weeks. General linear model repeated measures demonstrated no difference in trend of the two treatment groups (P = .897). There was no significantly different improvement in the HDRS scores from baseline to weeks 3 and 6, as well. Differences in response rate, remission rate, time to response and time to remission periods were not statistically significant. Finally, there was not any significantly difference between the two study groups in the frequency of adverse events.
WHAT IS NEW AND CONCLUSION


This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.",2020,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"['elderly patients with MDD', 'Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score\xa0≥\xa019', 'major depressive disorder in elderly patients', 'Fifty patients completed the trial after six weeks']","['vortioxetine', 'vortioxetine and sertraline', 'sertraline']","['HAM-D scale', 'HDRS scores', 'frequency of adverse events', 'efficacy and tolerability', 'efficacy and safety', 'HAM-D score, response rates, remission rate and time to response or remission', 'response rate, remission rate, time to response and time to remission periods']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",60.0,0.192844,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"[{'ForeName': 'Firouzeh', 'Initials': 'F', 'LastName': 'Borhannejad', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Shariati', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefe', 'Initials': 'A', 'LastName': 'Saeb', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed', 'Initials': 'S', 'LastName': 'Hosein Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kamalzadeh', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ali Noorbala', 'Affiliation': 'Psychosomatic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Namazi-Shabestari', 'Affiliation': 'Department of Geriatric, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13177']
1123,32424935,Liraglutide treatment in overweight and obese patients with type 1 diabetes: A 26-week randomized controlled trial; mechanisms of weight loss.,"AIM


To investigate the effects of liraglutide treatment on glycaemic control and adipose tissue metabolism in overweight and obese people with type 1 diabetes (T1DM).
RESEARCH DESIGN AND METHODS


A total of 84 adult overweight and obese patients with T1DM, with no detectable C-peptide, were randomized (1:1) to either placebo or 1.8 mg/d liraglutide for 6 months. Blood samples were collected at 0, 12 and 26 weeks. Subcutaneous adipose tissue biopsies, a high-calorie high-fat meal challenge test, continuous glucose monitoring, dual-energy X-ray absorptiometry and MRI were performed before and at the end of treatment.
RESULTS


In all, 37 and 27 patients who received liraglutide and placebo, respectively, completed the study. Glycated haemoglobin fell by 0.41 ± 0.18% (4.5±1.4 mmol/mol) from baseline after liraglutide treatment (P = 0.001), and by 0.29 ± 0.19% (3.1±2.0 mmol/mol) compared to placebo (P = 0.1). There was no increase in hypoglycaemia, while the time spent in normal glycaemia increased (P = 0.015) and time spent in hyperglycaemia decreased (P = 0.019). Body weight fell significantly in the liraglutide group, mostly in the form of fat mass loss (including visceral fat), with no change in lean mass. Systolic blood pressure (SBP) also fell after liraglutide treatment. Liraglutide also caused a significant increase in the expression of adipose tissue triglyceride lipase, carnitine palmitoyl transferase-1, peroxisome proliferator-activated receptor (PPAR)α, PPARδ, uncoupling protein-2 and type 2 iodothyronine deiodinase in the adipose tissue.
CONCLUSIONS


Liraglutide improves glycaemia, reduces adiposity and SBP. Liraglutide also stimulates mechanisms involved with an increase in lipid oxidation and thermogenesis, while conserving lean body mass.",2020,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"['adult overweight and obese', 'overweight and obese T1DM patients', '37 and 27 patients who received', 'patients with type 1 diabetes (T1DM', 'Overweight and Obese Patients with Type 1 Diabetes', '84']","['liraglutide', 'Liraglutide', 'liraglutide or placebo', 'Subcutaneous adipose tissue biopsies, high calorie high fat (HCHF) meal, CGM, DEXA', 'placebo']","['time spent in hyperglycemia', 'expression of ATGL, CPT-1, PPARα, PPARδ, UCP-2 and Dio-2 in the adipose tissue', 'lipid oxidation and thermogenesis', 'Blood samples', 'glycemic control, weight loss', 'hypoglycemia while the time spent in normal glycemia', 'Body weight', 'glycemic control and adipose tissue metabolism', 'systolic blood pressure (SBP', 'glycemia, reduces adiposity and SBP', 'SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007262', 'cui_str': 'Carnitine palmitoyltransferase'}, {'cui': 'C0854076', 'cui_str': 'Distal ileal obstruction syndrome'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",84.0,0.0906694,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"[{'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ghanim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Manav', 'Initials': 'M', 'LastName': 'Batra', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abuaysheh', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Hejna', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Antione', 'Initials': 'A', 'LastName': 'Makdissi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borowski', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Nitesh D', 'Initials': 'ND', 'LastName': 'Kuhadiya', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14090']
1124,29569727,Iron isomaltoside is superior to iron sucrose in increasing hemoglobin in gynecological patients with iron deficiency anemia.,,2018,,['gynecological patients with iron deficiency anemia'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]",[],[],,0.041596,,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Roman', 'Affiliation': 'Lakes Research, Miami Lakes, Florida.'}, {'ForeName': 'Gioi N', 'Initials': 'GN', 'LastName': 'Smith-Nguyen', 'Affiliation': 'Grossmont Center for Clinical Research, La Mesa, California.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Division of Hematology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Georgetown University School of Medicine, Washington, District of Columbia.'}]",American journal of hematology,['10.1002/ajh.25094']
1125,32424430,"A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study).","The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.",2020,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","['advanced/recurrent non-small-cell lung cancer patients', 'patients who have not progressed for a period of time', '216 patients will be enrolled over 3\xa0years', 'patients who have responded well to PD-1 pathway inhibitors for >12\xa0months', 'patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study']",['PD-1 pathway inhibitors'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],216.0,0.103545,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Kawai', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuma', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa054']
1126,25453536,Safety and tolerability of omecamtiv mecarbil during exercise in patients with ischemic cardiomyopathy and angina.,"OBJECTIVES


The goal of this study was to assess the safety and tolerability of omecamtiv mecarbil treatment during symptom-limited exercise in patients with ischemic cardiomyopathy and angina. These patients may have increased vulnerability to prolongation of the systolic ejection time.
BACKGROUND


Omecamtiv mecarbil is a selective cardiac myosin activator that augments cardiac contractility in patients with systolic heart failure through a dose-dependent increase in systolic ejection time.
METHODS


In this double-blind, placebo-controlled study, patients with chronic heart failure were randomized 2:1 to receive omecamtiv mecarbil or placebo in 2 sequential cohorts of escalating doses designed to achieve plasma concentrations previously shown to increase systolic function. Patients underwent 2 symptom-limited exercise treadmill tests (ETTs) at baseline (ETT1 and ETT2) and again before the end of a 20-h infusion of omecamtiv mecarbil (ETT3).
RESULTS


The primary pre-defined safety endpoint (i.e., the proportion of patients who stopped ETT3 because of angina at a stage earlier than baseline) was observed in 1 patient receiving placebo and none receiving omecamtiv mecarbil. No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events.
CONCLUSIONS


Doses of omecamtiv mecarbil producing plasma concentrations previously shown to increase systolic function were well tolerated during exercise in these study patients with ischemic cardiomyopathy and angina. There was no indication that treatment increased the likelihood of myocardial ischemia in this high-risk population. (Pharmacokinetics [PK] and Tolerability of Intravenous [IV] and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina; NCT00682565).",2015,"No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events.
","['patients with chronic heart failure', 'patients with ischemic cardiomyopathy and angina', 'patients with systolic heart failure', 'Patients With Ischemic Cardiomyopathy and Angina']","['omecamtiv mecarbil during exercise', 'omecamtiv mecarbil treatment', 'placebo', 'omecamtiv mecarbil or placebo', 'Intravenous [IV] and Oral CK-1827452', '2 symptom-limited exercise treadmill tests (ETTs) at baseline (ETT1 and ETT2) and again before the end of a 20-h infusion of omecamtiv mecarbil (ETT3']","['Pharmacokinetics [PK] and Tolerability', 'Safety and tolerability', 'systolic ejection time', 'likelihood of myocardial ischemia', 'safety and tolerability', 'systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}]","[{'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2932036', 'cui_str': 'CK 1827452'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0673008,"No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events.
","[{'ForeName': 'Barry H', 'Initials': 'BH', 'LastName': 'Greenberg', 'Affiliation': 'University of California at San Diego, San Diego, California. Electronic address: bgreenberg@ucsd.edu.'}, {'ForeName': 'Willis', 'Initials': 'W', 'LastName': 'Chou', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Khalil G', 'Initials': 'KG', 'LastName': 'Saikali', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Escandón', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Jacqueline H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Chen', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Treshkur', 'Affiliation': 'Almazov Federal Heart Blood and Endocrinology Centre, St. Petersburg, Russia.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Megreladze', 'Affiliation': 'Cardiology Clinic, Tbilisi, Georgia.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Eisenberg', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wolff', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Tamaz', 'Initials': 'T', 'LastName': 'Shaburishvili', 'Affiliation': 'Diagnostic Services Clinic, Tbilisi, Georgia.'}]",JACC. Heart failure,['10.1016/j.jchf.2014.07.009']
1127,31233662,Pain vs. comfort diary: A fully remote app-based experiment.,"BACKGROUND


Focusing on pain while completing a pain diary might have detrimental effects on pain intensity. Inverted comfort ratings might be used instead.
METHODS


A fully remote app-based registered experiment was conducted to investigate the effects of a pain versus comfort diary on 7-day recall ratings of pain intensity during a 3-week period. The diary included questions about past, current and expected pain or comfort. Randomization took place by the study app, thereby controlling for effects of experimenter bias.
RESULTS


Contrary to the study hypothesis, multilevel regression showed a more pronounced decrease in 7-day recall ratings of pain in the group who rated pain intensity daily (n = 184) than in the group who rated comfort daily (n = 205, B = -0.17, p = 0.034). There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference and happiness). Exploratory analyses revealed more pronounced decreases in pain intensity in participants who experienced less frequent pain in the previous 6 months. Correlations between pain and comfort ratings decreased from -0.39 at baseline to -0.06 after 3 weeks.
CONCLUSIONS


The findings do not support the potential beneficial effects of replacing diary ratings of pain intensity with diary ratings of comfort. The unexpected decreases among those who completed daily pain diaries might have been due to the inclusion of questions about expected pain. Decreasing correlations between pain and comfort ratings suggest that comfort ratings are not merely inverted pain ratings; rather, they appear to assess a domain distinct from pain intensity.
SIGNIFICANCE


The positive effects of pain diaries on pain trajectories appear to constitute a reliable effect and not a methodological artefact. Pain diaries should be investigated systematically to identify ways to optimize their effects on clinical outcomes. Comfort diaries, however, do not appear to be an efficacious substitute for pain diaries; if the current findings replicate, they indicate that primary care practitioners should continue to use pain diaries in clinical care.",2019,"There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference, and happiness).",['A fully remote app-based registered experiment'],['pain vs. comfort diary'],"['7-day recall ratings of pain', 'secondary outcomes (comfort, depressive symptoms, pain interference, and happiness', 'diary included questions about past, current and expected pain or comfort', 'frequent pain', 'pain and comfort ratings', '7-day recall ratings of pain intensity', 'pain intensity']","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0768825,"There were no between-group differences in secondary outcomes (comfort, depressive symptoms, pain interference, and happiness).","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Gruszka', 'Affiliation': 'Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Stammen', 'Affiliation': 'Faculty of Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Bissantz', 'Affiliation': 'Faculty of Mathematics, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}]","European journal of pain (London, England)",['10.1002/ejp.1446']
1128,25453534,Comparative assessment of short-term adverse events in acute heart failure with cystatin C and other estimates of renal function: results from the ASCEND-HF trial.,"OBJECTIVES


The purpose of this study was to investigate the predictive values of baseline and changes in cystatin C (CysC) and its derived equations for short-term adverse outcomes and the effect of nesiritide therapy on CysC in acute decompensated heart failure (ADHF).
BACKGROUND


Newer renal biomarkers or their derived estimates of renal function have demonstrated long-term prognostic value in chronic heart failure.
METHODS


CysC levels were measured in sequential plasma samples from 811 subjects with ADHF who were enrolled in the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) biomarker sub-study (randomized to nesiritide therapy vs. placebo), and followed for all-cause death (180 days) and recurrent hospital stay (30 days).
RESULTS


Median CysC levels were 1.49 (interquartile range [IQR]: 1.20 to 1.96) mg/l at baseline, 1.56 (IQR: 1.28 to 2.13) mg/l at 48 to 72 h, and 1.58 (IQR: 1.24 to 2.11) mg/l at 30 days. Higher baseline (but not follow-up) CysC levels were associated with increased risk of 30-day adverse events and less improvement in dyspnea after 24 h as well as 180-day mortality, although not incremental to blood urea nitrogen. Worsening renal function (defined as a 0.3 mg/l increase in CysC) occurred in 161 of 701 (23%) patients, but it was not predictive of adverse events. Changes in CysC levels were similar between the nesiritide and placebo groups.
CONCLUSIONS


Our findings confirmed the prognostic value of baseline CysC levels in the setting of ADHF. However, worsening renal function based on CysC rise was not predictive of adverse events. Nesiritide did not worsen renal function compared with placebo.",2015,"Higher baseline (but not follow-up) CysC levels were associated with increased risk of 30-day adverse events and less improvement in dyspnea after 24 h as well as 180-day mortality, although not incremental to blood urea nitrogen.","['acute decompensated heart failure (ADHF', '811 subjects with ADHF who were enrolled in the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure', 'acute heart failure with cystatin C and other estimates of renal function']","['nesiritide therapy vs. placebo', 'nesiritide therapy', 'placebo']","['cystatin C (CysC', 'CysC levels', 'dyspnea', 'Median CysC levels', 'risk of 30-day adverse events', 'CysC', 'recurrent hospital stay', 'Worsening renal function', 'renal function', 'worsening renal function']","[{'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",811.0,0.155992,"Higher baseline (but not follow-up) CysC levels were associated with increased risk of 30-day adverse events and less improvement in dyspnea after 24 h as well as 180-day mortality, although not incremental to blood urea nitrogen.","[{'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: tangw@ccf.org.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Hsu', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Cardiovascular Division, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Innovative Clinical Trials, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'Department of Cardiology, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Cardiology, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'Department of Cardiology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Cardiology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Massie', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JACC. Heart failure,['10.1016/j.jchf.2014.06.014']
1129,25457902,Effect of macitentan on hospitalizations: results from the SERAPHIN trial.,"OBJECTIVES


This study sought to evaluate the effect of macitentan on hospitalization of patients with symptomatic pulmonary arterial hypertension (PAH).
BACKGROUND


PAH is a progressive, life-threatening disease often requiring hospitalization.
METHODS


In the multicenter, double-blind, randomized, event-driven, phase III SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) trial, patients with symptomatic PAH were randomized (1:1:1) to receive placebo or 3 mg or 10 mg of macitentan. Effects of macitentan on the risk, rate, and number of hospital days for all-cause and PAH-related hospitalizations were compared with those for placebo. Risk and causes of hospitalizations unrelated to PAH were investigated.
RESULTS


Of 742 randomized patients, 250 received placebo, 250 received 3 mg of macitentan, and 242 received 10 mg of macitentan; the overall median duration of treatment was 115 weeks. Risk of all-cause hospitalization was reduced by 18.9% (p = 0.1208) and 32.3% (p = 0.0051) in the macitentan 3-mg and 10-mg arm, respectively. Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5% (p = 0.0378) and 30.6% (p = 0.0278), respectively, with 3 mg of macitentan and by 33.1% (p = 0.0005) and 31.0% (p = 0.0336), respectively, with 10 mg of macitentan. Risk of PAH-related hospitalizations were reduced by 42.7% (p = 0.0015) and 51.6% (p < 0.0001) in the macitentan 3-mg and 10-mg arms, respectively. Rate of PAH-related hospitalizations and numbers of hospital days were reduced by 44.5% (p = 0.0004) and 53.3% (p = 0.0001), respectively, with 3 mg of macitentan, and reduced by 49.8% (p < 0.0001) and 52.3% (p = 0.0003), respectively, with 10 mg of macitentan. Risk of non-PAH-related hospitalization was similar between treatment arms.
CONCLUSIONS


Macitentan 10 mg significantly reduced the risk and rate of all-cause hospitalization, which was driven by reductions in the risk and rate of PAH-related hospitalization. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension; NCT00660179).",2015,"Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5% (p = 0.0378) and 30.6% (p = 0.0278), respectively, with 3 mg of macitentan and by 33.1% (p = 0.0005) and 31.0% (p = 0.0336), respectively, with 10 mg of macitentan.","['patients with symptomatic PAH', 'patients with symptomatic pulmonary arterial hypertension (PAH', '742 randomized patients', 'Patients With Symptomatic Pulmonary Arterial Hypertension']","['placebo', 'Endothelin Receptor Antagonist', 'macitentan', 'placebo, 250 received 3 mg of macitentan, and 242 received 10 mg of macitentan', 'placebo or 3 mg or 10 mg of macitentan']","['Risk of non-PAH-related hospitalization', 'Risk of all-cause hospitalization', 'Risk of PAH-related hospitalizations', 'risk and rate of all-cause hospitalization', 'Rates of all-cause hospitalizations and numbers of hospital days', 'Morbidity and Mortality', 'risk, rate, and number of hospital days for all-cause and PAH-related hospitalizations', 'hospitalizations', 'Rate of PAH-related hospitalizations and numbers of hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1134681', 'cui_str': 'Endothelin Antagonists'}, {'cui': 'C2606556', 'cui_str': 'Macitentan'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",742.0,0.447635,"Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5% (p = 0.0378) and 30.6% (p = 0.0278), respectively, with 3 mg of macitentan and by 33.1% (p = 0.0005) and 31.0% (p = 0.0336), respectively, with 10 mg of macitentan.","[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Channick', 'Affiliation': 'Pulmonary and Critical Care, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: rchannick@mgh.harvard.edu.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Delcroix', 'Affiliation': 'Department of Pneumology, Gasthuisberg University Hospital, Leuven, Belgium.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hunsche', 'Affiliation': 'Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Jansa', 'Affiliation': 'Clinical Department of Cardiology and Angiology, 1st Faculty of Medicine, 2nd Medical Department, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Franck-Olivier', 'Initials': 'FO', 'LastName': 'Le Brun', 'Affiliation': 'Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Respirology, Department of Medicine, London Health Sciences Centre-Victoria Hospital, Western University, London, Ontario, Canada.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pulido', 'Affiliation': 'Cardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego Medical School, San Diego, California.'}, {'ForeName': 'B K S', 'Initials': 'BKS', 'LastName': 'Sastry', 'Affiliation': 'Department of Cardiology, CARE Hospitals, Hyderabad, India.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France; INSERM U-999, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France; INSERM U-999, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France.""}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Souza', 'Affiliation': 'Pulmonary Department, Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center of Postgraduate Education, ECZ-Otwock, Poland.'}, {'ForeName': 'Nazzareno', 'Initials': 'N', 'LastName': 'Galiè', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine-DIMES, Bologna University Hospital, Bologna, Italy.'}]",JACC. Heart failure,['10.1016/j.jchf.2014.07.013']
1130,31339008,"Premeal Consumption of a Protein-Enriched, Dietary Fiber-Fortified Bar Decreases Total Energy Intake in Healthy Individuals.","BACKGROUND


A premeal load of protein can increase satiety and reduce energy intake. Dietary fiber also conveys metabolic benefits by modulating energy intake. We made a protein-enriched, dietary fiber-fortified bar (PFB) and aimed to investigate its effects on food intake and gut hormone secretion in healthy individuals.
METHODS


Twenty subjects with normal glucose tolerance were enrolled. On three separate visits, the subjects received, in a randomized order, one of the following: a PFB containing 73 kcal with 10.7 g of protein and 12.7 g of dietary fiber; a usual bar (UB) containing the same calories as the PFB but only 0.9 g of protein and no dietary fiber; or water (control). After 15 minutes, the subjects had  ad libitum  intake of a test meal. Food consumption, appetite, and plasma gut hormone levels were measured.
RESULTS


Total energy intake, including the bar and the test meal, was significantly reduced with the PFB preload compared to the water (904.4±534.9 kcal vs. 1,075.0±508.0 kcal,  P =0.016). With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water. Fullness was also significantly increased after the PFB. In addition, postprandial glucose levels decreased and glucagon-like peptide-1 levels increased with the PFB compared with both the UB and water.
CONCLUSION


In healthy individuals, a premeal supplementation of PFB reduced total energy intake and decreased postprandial glucose excursion. This finding necessitates long-term studies regarding clinical use in obesity.",2019,"With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water.","['healthy individuals', 'Healthy Individuals', 'Twenty subjects with normal glucose tolerance were enrolled']","['Premeal Consumption of a Protein-Enriched, Dietary Fiber-Fortified Bar', 'protein-enriched, dietary fiber-fortified bar (PFB', 'PFB containing 73 kcal with 10.7 g of protein and 12.7 g of dietary fiber; a usual bar (UB) containing the same calories as the PFB but only 0.9 g of protein and no dietary fiber; or water (control']","['PFB preload', 'Fullness', 'postprandial glucose levels decreased and glucagon-like peptide-1 levels', 'Total energy intake', 'total energy intake', 'total energy intake and decreased postprandial glucose excursion', 'Food consumption, appetite, and plasma gut hormone levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",20.0,0.0174969,"With the UB preload, only the intake of the test meal was reduced ( P =0.044) but not the total energy intake ( P =0.471) than the water.","[{'ForeName': 'Chang Ho', 'Initials': 'CH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. ymchomd@snu.ac.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2018.0202']
1131,32418361,"Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal-Dominant Alzheimer's Disease Colombia Trial.","INTRODUCTION


The API AutosomalDominant AD (ADAD) Colombia Trial is a placebo-controlled clinical trial of crenezumab in 252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1) E280A kindred members, including mutation carriers randomized to active treatment or placebo and non-carriers who receive placebo.
METHODS


Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity.
RESULTS


We summarize demographic, clinical, cognitive, and behavioral data from 167 mutation carriers and 75 non-carriers, 30 to 53 years of age. Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
DISCUSSION


Although PSEN1 E280A mutation carriers in the Trial are cognitively unimpaired, they have slightly lower MMSE and memory scores than non-carriers. Their demographic characteristics are representative of the local population.",2020,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","['167 mutation carriers and 75 non-carriers, 30 to 53 years of age', '252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1', 'Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity', 'E280A kindred members, including mutation carriers randomized to active treatment or']","['API AutosomalDominant AD (ADAD', 'placebo and non-carriers who receive placebo', 'crenezumab', 'placebo']",['Mini Mental Status Exam (MMSE) scores'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0299212', 'cui_str': 'Presenilin 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.37236,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Rios-Romenets', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lopera', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cho', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Mackey', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Langbaum', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'University of California, San Diego, California, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giraldo-Chica', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tobon', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Acosta-Baena', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ospina', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Tirado', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Henao', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Bocanegra', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Dhruman', 'Initials': 'D', 'LastName': 'Goradia', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Thiyyagura', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'VanGilder', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ghisays', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Malek-Ahmadi', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Protas', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reiman', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12109']
1132,24963884,Inhibitory control as a mediator of bidirectional effects between early oppositional behavior and maternal depression.,"Maternal depression is an established risk factor for child conduct problems, but relatively few studies have tested whether children's behavioral problems exacerbate mothers' depression or whether other child behavioral characteristics (e.g., self-regulation) may mediate bidirectional effects between maternal depression and child disruptive behavior. This longitudinal study examined the parallel growth of maternal depressive symptoms and child oppositional behavior from ages 2 to 5; the magnitude and timing of their bidirectional effects; and whether child inhibitory control, a temperament-based self-regulatory mechanism, mediated effects between maternal depression and child oppositionality. A randomized control trial of 731 at-risk families assessed children annually from ages 2 to 5. Transactional models demonstrated positive and bidirectional associations between mothers' depressive symptoms and children's oppositional behavior from ages 2 to 3, with a less consistent pattern of reciprocal relations up to age 5. Mediation of indirect mother-child effects and child evocative effects depended on the rater of children's inhibitory control. Findings are discussed in regard to how child evocative effects and self-regulatory mechanisms may clarify the transmission of psychopathology within families.",2014,Mediation of indirect mother-child effects and child evocative effects depended on the rater of children's inhibitory control.,['731 at-risk families assessed children annually from ages 2 to 5'],[],['maternal depressive symptoms and child oppositional behavior'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",731.0,0.0213333,Mediation of indirect mother-child effects and child evocative effects depended on the rater of children's inhibitory control.,"[{'ForeName': 'Daniel Ewon', 'Initials': 'DE', 'LastName': 'Choe', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Lauretta M', 'Initials': 'LM', 'LastName': 'Brennan', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Arizona State University.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'University of Virginia.'}]",Development and psychopathology,['10.1017/S0954579414000613']
1133,24831445,Nitric oxide synthase inhibition with the antipterin VAS203 improves outcome in moderate and severe traumatic brain injury: a placebo-controlled randomized Phase IIa trial (NOSTRA).,"Traumatic brain injury (TBI) is an important cause of death and disability. Safety and pharmacodynamics of 4-amino-tetrahydrobiopterin (VAS203), a nitric oxide (NO)-synthase inhibitor, were assessed in TBI in an exploratory Phase IIa study (NOSynthase Inhibition in TRAumatic brain injury=NOSTRA). The study included 32 patients with TBI in six European centers. In a first open Cohort, eight patients received three 12-h intravenous infusions of VAS203 followed by a 12-h infusion-free interval over 3 days (total dose 15 mg/kg). Patients in Cohorts 2 and 3 (24) were randomized 2:1 to receive either VAS203 or placebo as an infusion for 48 or 72 h, respectively (total dose 20 and 30 mg/kg). Effects of VAS203 on intracranial pressure (ICP), cerebral perfusion pressure (CPP), brain metabolism using microdialysis, and the therapy intensity level (TIL) were end points. In addition, exploratory analysis of the extended Glasgow Outcome Score (eGOS) after 6 months was performed. Metabolites of VAS203 were detected in cerebral microdialysates. No significant differences between treatment and placebo groups were observed for ICP, CPP, and brain metabolism. TIL on day 6 was significantly decreased (p<0.04) in the VAS203 treated patients. The eGOS after 6 months was significantly higher in treated patients compared with placebo (p<0.01). VAS203 was not associated with hepatic, hematologic, or cardiac toxic effects. At the highest dose administered, four of eight patients receiving VAS203 showed transitory acute kidney injury (stage 2-3). In conclusion, the significant improvement in clinical outcome indicates VAS203-mediated neuroprotection after TBI. At the highest dose, VAS203 is associated with a risk of acute kidney injury.",2014,The eGOS after 6 months was significantly higher in treated patients compared with placebo (p<0.01).,"['Patients in Cohorts 2 and 3 (24', 'Traumatic brain injury (TBI', 'moderate and severe traumatic brain injury', '32 patients with TBI in six European centers']","['placebo', 'VAS203 or placebo', '4-amino-tetrahydrobiopterin (VAS203), a nitric oxide (NO)-synthase inhibitor', 'VAS203', 'Nitric oxide synthase inhibition with the antipterin VAS203']","['ICP, CPP, and brain metabolism', 'intracranial pressure (ICP), cerebral perfusion pressure (CPP), brain metabolism using microdialysis, and the therapy intensity level (TIL', 'transitory acute kidney injury', 'eGOS', 'Metabolites of VAS203', 'hepatic, hematologic, or cardiac toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045572', 'cui_str': 'VAS203'}, {'cui': 'C0540914', 'cui_str': '4-amino-tetrahydrobiopterin'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}, {'cui': 'C0206056', 'cui_str': 'Microdialysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C4045572', 'cui_str': 'VAS203'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",32.0,0.373618,The eGOS after 6 months was significantly higher in treated patients compared with placebo (p<0.01).,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Stover', 'Affiliation': '1 University Hospital Zuerich , Zuerich, Switzerland .'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belli', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Boret', 'Affiliation': ''}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Bulters', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sahuquillo', 'Affiliation': ''}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Schmutzhard', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Zavala', 'Affiliation': ''}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Ungerstedt', 'Affiliation': ''}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Schinzel', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tegtmeier', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurotrauma,['10.1089/neu.2014.3344']
1134,31855850,Adults Want to Play Too: Feasibility of an Adult Physical Activity Program Designed to Maximize Enjoyment.,"BACKGROUND


Few adults in the United States obtain sufficient physical activity (PA) despite knowledge of the associated health benefits. The current feasibility study examined the feasibility of a novel modified sports intervention designed to promote enjoyment and sustained PA in sedentary adults.
METHODS


The US adults (N = 22, mean age 39.2 y, male/female percentage 54.5/45.5) in Central Pennsylvania participated in the PlayFit sports program for 60-minute sessions, 2 to 3 times per week, over the course of 10 weeks and 24 game sessions; completing 198 person sessions collectively. Primary outcomes were PA (accelerometry) and intervention satisfaction.
RESULTS


Percentage of time in moderate to vigorous activity ranged from 35.0% (volleyball) to 91.2% (ultimate frisbee). Percentage of time spent in vigorous activity ranged from 0.0% (volleyball) to 29.5% (team handball). Satisfaction, based on a 10-point scale with 10 being the most satisfied, ranged from 7.7 (kickball) to 8.7 (floor hockey and soccer). On average, all sports were rated highly, with the majority rated >8.5 and one rated <8.0. Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
CONCLUSIONS


PlayFit is a promising first step in exploring the potential of modified sports programs to enhance population PA levels.",2020,"Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
","['US adults (N = 22, mean age 39.2\xa0y, male/female percentage 54.5/45.5) in Central Pennsylvania participated in the', 'sedentary adults']","['Adult Physical Activity Program', 'PlayFit sports program', 'novel modified sports intervention']","['PA (accelerometry) and intervention satisfaction', 'Percentage of time spent']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0202905,"Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
","[{'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Upham', 'Affiliation': ''}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Auer', 'Affiliation': ''}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Sciamanna', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mowen', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Silvis', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kraschnewski', 'Affiliation': ''}, {'ForeName': 'Liza S', 'Initials': 'LS', 'LastName': 'Rovniak', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lehman', 'Affiliation': ''}, {'ForeName': 'Kalen', 'Initials': 'K', 'LastName': 'Kearcher', 'Affiliation': ''}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Vizzini', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Cesarone', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0306']
1135,31855848,Influence of Obesity and Impact of a Physical Activity Program on Postural Control and Functional and Physical Capacities in Institutionalized Older Adults: A Pilot Study.,"OBJECTIVE


To evaluate the role of obesity in the effects of physical activity (PA) on postural control and functional and physical capacities in the older adults and to assess the effectiveness of a PA program on these capacities.
METHODS


Six obese (age = 78.8 [3.7] y; body mass index > 30 kg/m2), 7 overweight (age = 80.9 [2.8] y; 25 < body mass index < 30 kg/m2), and 6 normal weight (age = 80.8 [5.7] y; body mass index < 25 kg/m2) older adults performed the time up and go test, the 6-minute walk test, and the Tinetti test. Static and dynamic (forward leaning) postural control tests were also assessed. All these tests were similarly assessed 4 months later, during which only the obese group and overweight group participated in a PA program.
RESULTS


Before PA, results of the time up and go test, 6-minute walk test, Tinetti test, quiet standing, and forward lean tests revealed that physical capacities and static and dynamic postural control were impaired in the obese group when compared to the normal weight group. After PA, results of quiet standing, physical and functional tests were improved for obese group.
CONCLUSIONS


Obesity is an additional constraint to age-related postural control and functional and physical capacities deteriorations. Nevertheless, a PA program is effective in improving balance and functional capacities in obese older adults.",2020,"After PA, results of quiet standing, physical and functional tests were improved for obese group.
","['Six obese (age', '25 < body mass index < 30\xa0kg/m2), and 6 normal weight (age = 80.8 [5.7', 'older adults', 'obese older adults', 'y', 'y; body mass index < 25\xa0kg/m2) older adults', '30\xa0kg/m2), 7 overweight (age = 80.9 [2.8', 'Institutionalized Older Adults']","['physical activity (PA', 'Physical Activity Program', 'PA program']","['body mass index ', 'Postural Control and Functional and Physical Capacities', 'postural control and functional and physical capacities', 'Static and dynamic (forward leaning) postural control tests', 'time up and go test, 6-minute walk test, Tinetti test, quiet standing, and forward lean tests revealed that physical capacities and static and dynamic postural control', 'quiet standing, physical and functional tests', 'balance and functional capacities']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",6.0,0.0156247,"After PA, results of quiet standing, physical and functional tests were improved for obese group.
","[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Maktouf', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Durand', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Beaune', 'Affiliation': ''}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Boyas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0376']
1136,32421411,"Re: Effect of Tadalafil 5 mg on Post-Micturition Dribble in Men with Lower Urinary Tract Symptoms: A Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial.",,2020,,['Men with Lower Urinary Tract Symptoms'],"['Tadalafil', 'Placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.61342,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001118.04']
1137,32130164,Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial.,"BACKGROUND


Problems with prospective memory, which refers to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users' attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence.
OBJECTIVE


This study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults.
METHODS


A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique.
RESULTS


The treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD's external cues not only improved older adults' medication adherence but also mediated family caregivers' involvement.
CONCLUSIONS


The findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04289246; https://tinyurl.com/ufjcz97.",2020,"We also found that the MAD's external cues not only improved older adults' medication adherence but also mediated family caregivers' involvement.
","['16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study', 'Older Mexican Adults', 'Older adults', 'older adults']","['External Cues', 'external cues', 'Ambient Displays']","[""older adults' medication adherence"", 'medication adherence rate', 'medication adherence', 'adherence behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0516638', 'cui_str': 'Adherence behavior'}]",16.0,0.0417377,"We also found that the MAD's external cues not only improved older adults' medication adherence but also mediated family caregivers' involvement.
","[{'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Zárate-Bravo', 'Affiliation': 'Facultad de Ingeniería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'García-Vázquez', 'Affiliation': 'Facultad de Ingeniería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Engracia', 'Initials': 'E', 'LastName': 'Torres-Cervantes', 'Affiliation': 'Facultad de Enfermería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Ponce', 'Affiliation': 'Facultad de Enfermería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Ángel G', 'Initials': 'ÁG', 'LastName': 'Andrade', 'Affiliation': 'Facultad de Ingeniería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Valenzuela-Beltrán', 'Affiliation': 'Facultad de Ingeniería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}, {'ForeName': 'Marcela D', 'Initials': 'MD', 'LastName': 'Rodríguez', 'Affiliation': 'Facultad de Ingeniería, Universidad Autónoma de Baja California, Mexicali, Mexico.'}]",JMIR mHealth and uHealth,['10.2196/14680']
1138,32421440,Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.,"PURPOSE


The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy.
METHODS


Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes.
RESULTS


One hundred fifteen patients from the TIME trial (59 MIE  v  56 open) and 4,605 patients from the DUCA dataset (2,652 MIE  v  1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay.
CONCLUSION


When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.",2020,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","['Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017', 'One hundred fifteen patients from the TIME trial (59 MIE  v  56 open) and 4,605 patients from the DUCA dataset ']","['MIE versus open esophagectomy', 'Minimally Invasive Esophagectomy', 'minimally invasive esophagectomy (MIE']","['total complications', 'total and pulmonary complications and reoperation rate', 'pulmonary complications', 'pulmonary complications and length of hospital stay', 'length of hospital stay', 'reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay', '30-day mortality', 'total and pulmonary complications and reoperations', 'MIE reduced pulmonary complications']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",115.0,0.249686,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","[{'ForeName': 'Sheraz R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'van der Werf', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02483']
1139,32421401,Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section.,"OBJECTIVE


Assess the efficacy and safety of carbetocin, versus oxytocin in the prevention of postpartum hemorrhage in hypertensive women.
STUDY DESIGN


A randomized clinical trial.
SETTING


Obstetrics and Gynecology Department of Suez Canal University Hospital.
PATIENTS


One hundred and sixty hypertensive pregnant women who underwent CS.
INTERVENTIONS


Patients were randomized to receive either 10 IU oxytocin or 100 μg carbetocin. Primary outcomes included estimated blood loss, blood transfusion, hemoglobin (HB), and hematocrit changes pre- and post-delivery and the use of additional uterotonics.
RESULTS


The postoperative HB was not different from preoperative HB in the carbetocin group (11.8 ± 1.2 vs. 11.2 ± 1.2 g/dL) while it decreased significantly in the oxytocin group (12.1 ± 3.8 vs. 10.4 ± 1.1 g/dL, p < 0.001). Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001). Nausea, vomiting, and sweating were reported more significantly in oxytocin group patients.
CONCLUSION


Carbetocin was more effective than oxytocin in reducing intraoperative and postoperative blood loss.",2020,Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001).,"['One hundred and sixty hypertensive pregnant women who underwent CS', 'hypertensive women', 'Setting : Obstetrics and Gynecology Department of Suez Canal University Hospital', 'hypertensive women undergoing elective cesarean section', 'Patients ']","['10 IU oxytocin', 'carbetocin, versus oxytocin', 'Carbetocin versus oxytocin', 'oxytocin']","['Blood loss', 'postoperative HB', 'Nausea, vomiting, and sweating', 'intraoperative and postoperative blood loss', 'estimated blood loss, blood transfusion, hemoglobin (HB), and hematocrit changes pre- and post-delivery and the use of additional uterotonics']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0054670', 'cui_str': 'carbetocin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}]",160.0,0.217339,Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001).,"[{'ForeName': 'Zakia M', 'Initials': 'ZM', 'LastName': 'Ibrahim', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University , Ismailia, Egypt.'}, {'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Sayed Ahmed', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University , Ismailia, Egypt.'}, {'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Abd El-Hamid', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University , Ismailia, Egypt.'}, {'ForeName': 'Omima T', 'Initials': 'OT', 'LastName': 'Taha', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University , Ismailia, Egypt.'}, {'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Elbahie', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University , Ismailia, Egypt.'}]",Hypertension in pregnancy,['10.1080/10641955.2020.1768268']
1140,29985969,Effects of Mental Fatigue on Exercise Intentions and Behavior.,"BACKGROUND


Exerting cognitive control results in mental fatigue, which is associated with impaired performance during physical endurance tasks. However, there has been little research on the effects of mental fatigue on people's perceptions or behaviors involving lifestyle or recreational exercise.
PURPOSE


The purpose of this study was to examine the effect of mental fatigue on intended physical exertion and exercise performance reflective of current physical activity guidelines.
METHODS


Using a counterbalanced design, participants completed two 50-min experimental manipulations (high vs. low cognitive control exertion) before exercising at a self-selected intensity for 30 min. At visit 1, participants performed a graded exercise task to gain familiarity with a range of exercise intensities and rating of perceived exertion (RPE) while exercising. At visits 2 and 3, participants rated their intended RPE for the exercise session, performed the experimental manipulations, re-rated their intended RPE, and then completed 30-min of exercise on a cycle ergometer. Total work performed while exercising was recorded for each session.
RESULTS


Compared with the low cognitive control condition, the high cognitive control manipulation resulted in significantly greater mental fatigue (d = .73), significantly greater reductions in intended RPE (mean difference = -0.62), and significantly less total work (-12.7 kJ) performed during the exercise session.
CONCLUSIONS


Mental fatigue alters the amount of physical effort people are willing to invest in an exercise workout and follow through with those intentions by doing less work. These are the first results showing people may deliberately adjust their physical effort to cope with mental fatigue.",2019,"Compared with the low cognitive control condition, the high cognitive control manipulation resulted in significantly greater mental fatigue (d = .73), significantly greater reductions in intended RPE (mean difference = -0.62), and significantly less total work (-12.7 kJ) performed during the exercise session.
",[],"['graded exercise task to gain familiarity with a range of exercise intensities and rating of perceived exertion (RPE) while exercising', 'Mental Fatigue', '50-min experimental manipulations (high vs. low cognitive control exertion']","['mental fatigue', 'intended RPE']",[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",,0.0452747,"Compared with the low cognitive control condition, the high cognitive control manipulation resulted in significantly greater mental fatigue (d = .73), significantly greater reductions in intended RPE (mean difference = -0.62), and significantly less total work (-12.7 kJ) performed during the exercise session.
","[{'ForeName': 'Denver M Y', 'Initials': 'DMY', 'LastName': 'Brown', 'Affiliation': 'McMaster University, Department of Kinesiology, Hamilton, ON, Canada.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Bray', 'Affiliation': 'McMaster University, Department of Kinesiology, Hamilton, ON, Canada.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay052']
1141,31386821,Short-term high-Intensity interval training increases systemic brain-derived neurotrophic factor (BDNF) in healthy women.,"BACKGROUND


Brain-derived neurotrophic factor (BDNF) increases neuronal viability and cognitive function, peripheral lipid metabolism and skeletal muscle repair. The primary purpose of this study was to determine the effect of short-term high-intensity interval training (HIIT) on serum BDNF concentrations in healthy young women.
METHODS


Seventeen women (age:22 ± 1 years); body mass index (BMI:24.2 ± 2.2 kg/m²), body fat percentage (% fat:25.8 ± 4.7) participated in the study. Participants were randomly assigned to a control ( n  = 8) or HIIT group ( n  = 9). All participants performed a graded exercise test (GXT) on an electronically-braked cycle ergometer to determine maximal aerobic power (MAP, Watts). HIIT was performed three days per week for four weeks. Each HIIT session consisted of three to five cycling bouts of 30 s each at 80% MAP, followed by four-minutes of recovery at 40% MAP. Forty-eight hours after the last bout of exercise, both groups performed a follow-up GXT. Non-fasting blood samples were collected before and immediately after each GXT. Mixed factorial (2 groups x 4 measures, and 2 groups x 2 measures) ANOVA was used to assess BDNF concentrations, performance and anthropometric variables.
RESULTS


Serum BDNF concentrations in the HIIT group (21.9 ± 1.3 ng/mL) increased compared to control (19.2 ± 2.8 ng/mL) (∼12%,  P  < 0.05) following HIIT. In contrast, circulating BDNF concentrations were reduced following the GXT ( P  < 0.05). The MAP and % Fat did not change with HIIT.
CONCLUSIONS


Twelve sessions of HIIT increases circulating BDNF concentrations in healthy young women despite no change in physical performance or % fat.",2020,"RESULTS


Serum BDNF concentrations in the HIIT group (21.9 ± 1.3 ng/mL) increased compared to control (19.2 ± 2.8 ng/mL) (∼12%,  P  < 0.05) following HIIT.","['Seventeen women (age:22\u2009±\u20091 years); body mass index (BMI:24.2\u2009±\u20092.2\u2005kg/m²), body fat percentage (% fat:25.8\u2009±\u20094.7) participated in the study', 'healthy young women', 'healthy women']","['Short-term high-Intensity interval training', 'short-term high-intensity interval training (HIIT', 'Brain-derived neurotrophic factor (BDNF', 'graded exercise test (GXT) on an electronically-braked cycle ergometer to determine maximal aerobic power (MAP, Watts']","['BDNF concentrations, performance and anthropometric variables', 'Serum BDNF concentrations', 'serum BDNF concentrations', 'circulating BDNF concentrations', 'neuronal viability and cognitive function, peripheral lipid metabolism and skeletal muscle repair']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0337108', 'cui_str': 'Sheet metal bending equipment'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]",17.0,0.0510853,"RESULTS


Serum BDNF concentrations in the HIIT group (21.9 ± 1.3 ng/mL) increased compared to control (19.2 ± 2.8 ng/mL) (∼12%,  P  < 0.05) following HIIT.","[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rentería', 'Affiliation': 'Facultad de Deportes Campus Ensenada, Universidad Autónoma de Baja California, México.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'García-Suárez', 'Affiliation': 'Facultad de Deportes Campus Ensenada, Universidad Autónoma de Baja California, México.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Martínez-Corona', 'Affiliation': 'Escuela de Ciencias de la Salud Campus Ensenada, Universidad Autónoma de Baja California, México.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Moncada-Jiménez', 'Affiliation': 'Human Movement Sciences Research Center, University of Costa Rica, Costa Rica.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Plaisance', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'JiméNez-Maldonado', 'Affiliation': 'Facultad de Deportes Campus Ensenada, Universidad Autónoma de Baja California, México.'}]",European journal of sport science,['10.1080/17461391.2019.1650120']
1142,30020401,Predictors of Adherence to Different Volumes of Exercise in the Breast Cancer and Exercise Trial in Alberta.,"BACKGROUND


Exercise demonstrates a dose-response effect on many health outcomes; however, adhering to higher doses of exercise can be challenging, and the predictors of adherence may differ based on exercise volume.
PURPOSE


To examine the predictors of adherence to two different volumes of aerobic exercise within the Breast Cancer and Exercise Trial in Alberta (BETA).
METHODS


In BETA, we randomized 400 inactive but healthy postmenopausal women to either a moderate volume (150 min/week) or a high volume (300 min/week) of aerobic exercise for 1 year. We collected data on several predictors of exercise adherence at baseline and used linear and mixed-effect models to determine predictors of exercise adherence to exercise volume and overall.
RESULTS


Adherence was higher in the moderate-volume group (84.5%) compared with the high-volume group (75.2%; p < .001). There were no statistically significant interactions between predictors of exercise adherence and exercise volume. Overall, we found that exercise adherence was predicted by randomization group, body mass index (BMI), employment status, and physical health. Adherence was 8.6% lower in the high-volume versus moderate-volume group, 6.7% lower for women working full time versus not, 0.8% lower per BMI increase of 1 kg/m2, and 0.5% higher per unit of physical health.
CONCLUSIONS


Adherence to high-volume aerobic exercise was more challenging than for moderate-volume aerobic exercise, but the predictors of adherence were similar. Moreover, few factors were major predictors of exercise adherence in this setting suggesting that well-controlled efficacy trials that produce high adherence rates may reduce the influence of individual characteristics on exercise adherence.
TRIAL REGISTRATION


NCT1435005.",2019,"RESULTS


Adherence was higher in the moderate-volume group (84.5%) compared with the high-volume group (75.2%; p < .001).","['400 inactive but healthy postmenopausal women to either a moderate volume (150 min/week) or a high volume (300 min/week) of', 'Breast Cancer and Exercise Trial in Alberta']","['aerobic exercise', 'high-volume aerobic exercise']","['exercise adherence and exercise volume', 'Adherence', 'body mass index (BMI), employment status, and physical health', 'exercise adherence']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",400.0,0.0842284,"RESULTS


Adherence was higher in the moderate-volume group (84.5%) compared with the high-volume group (75.2%; p < .001).","[{'ForeName': 'Chelsea R', 'Initials': 'CR', 'LastName': 'Stone', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Farris', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Vallerand', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, University Hall, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dong-Woo', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, University Hall, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, University Hall, Edmonton, Alberta, Canada.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay057']
1143,23121377,Tolvaptan in patients with autosomal dominant polycystic kidney disease.,"BACKGROUND


The course of autosomal dominant polycystic kidney disease (ADPKD) is often associated with pain, hypertension, and kidney failure. Preclinical studies indicated that vasopressin V(2)-receptor antagonists inhibit cyst growth and slow the decline of kidney function.
METHODS


In this phase 3, multicenter, double-blind, placebo-controlled, 3-year trial, we randomly assigned 1445 patients, 18 to 50 years of age, who had ADPKD with a total kidney volume of 750 ml or more and an estimated creatinine clearance of 60 ml per minute or more, in a 2:1 ratio to receive tolvaptan, a V(2)-receptor antagonist, at the highest of three twice-daily dose regimens that the patient found tolerable, or placebo. The primary outcome was the annual rate of change in the total kidney volume. Sequential secondary end points included a composite of time to clinical progression (defined as worsening kidney function, kidney pain, hypertension, and albuminuria) and rate of kidney-function decline.
RESULTS


Over a 3-year period, the increase in total kidney volume in the tolvaptan group was 2.8% per year (95% confidence interval [CI], 2.5 to 3.1), versus 5.5% per year in the placebo group (95% CI, 5.1 to 6.0; P<0.001). The composite end point favored tolvaptan over placebo (44 vs. 50 events per 100 follow-up-years, P=0.01), with lower rates of worsening kidney function (2 vs. 5 events per 100 person-years of follow-up, P<0.001) and kidney pain (5 vs. 7 events per 100 person-years of follow-up, P=0.007). Tolvaptan was associated with a slower decline in kidney function (reciprocal of the serum creatinine level, -2.61 [mg per milliliter](-1) per year vs. -3.81 [mg per milliliter](-1) per year; P<0.001). There were fewer ADPKD-related adverse events in the tolvaptan group but more events related to aquaresis (excretion of electrolyte-free water) and hepatic adverse events unrelated to ADPKD, contributing to a higher discontinuation rate (23%, vs. 14% in the placebo group).
CONCLUSIONS


Tolvaptan, as compared with placebo, slowed the increase in total kidney volume and the decline in kidney function over a 3-year period in patients with ADPKD but was associated with a higher discontinuation rate, owing to adverse events. (Funded by Otsuka Pharmaceuticals and Otsuka Pharmaceutical Development and Commercialization; TEMPO 3:4 ClinicalTrials.gov number, NCT00428948.).",2012,"Tolvaptan was associated with a slower decline in kidney function (reciprocal of the serum creatinine level, -2.61","['1445 patients, 18 to 50 years of age, who had ADPKD with a total kidney volume of 750 ml or more and an estimated creatinine clearance of 60 ml per minute or more, in a 2:1 ratio to receive tolvaptan, a V(2)-receptor antagonist, at the highest of three twice-daily dose regimens that the patient found tolerable, or', 'patients with autosomal dominant polycystic kidney disease']","['Tolvaptan', 'placebo']","['composite of time to clinical progression (defined as worsening kidney function, kidney pain, hypertension, and albuminuria) and rate of kidney-function decline', 'total kidney volume', 'kidney function', 'kidney function (reciprocal of the serum creatinine level', 'annual rate of change in the total kidney volume', 'kidney pain', 'discontinuation rate', 'worsening kidney function', 'ADPKD-related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0558489', 'cui_str': 'Renal pain (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1445.0,0.424994,"Tolvaptan was associated with a slower decline in kidney function (reciprocal of the serum creatinine level, -2.61","[{'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA. torres.vicente@mayo.edu'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Devuyst', 'Affiliation': ''}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': ''}, {'ForeName': 'Jared J', 'Initials': 'JJ', 'LastName': 'Grantham', 'Affiliation': ''}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higashihara', 'Affiliation': ''}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': ''}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Krasa', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ''}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1205511']
1144,32035854,Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing.,"INTRODUCTION


Active learning methods have accumulated popularity due to improved results in knowledge acquisition as opposed to passive learning methods. For surgical resident physicians with limited training opportunities outside of the operating room due to time constraints, virtual reality (VR) is a relatively inexpensive and time-efficient active training method for procurement of surgical skills. We conducted a simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs as a more effective modality of learning orthopedic surgical techniques compared to passive learning tools such as a standard guide (SG) through trained novice medical students performing a SawBones simulation of intramedullary nail fixation.
MATERIALS AND METHODS


First and second-year medical students without prior experience of procedure were recruited and randomized to SG or VR training. Participants were observed performing simulated tibia IMN procedure immediately after training and evaluated by a blinded attending surgeon using procedure-specific checklist and 5-point global assessment scale. Participants returned after 2-weeks for repeat training and evaluation.
RESULTS


20 participants were recruited and randomized into VR (n = 10) and SG (n = 10) groups. All 20 participants completed the first phase and 17 completed the second phase of the study. Aggregate global assessment scores were significantly higher for VR than SG group (17.5 vs. 7.5, p < 0.001), including scores in all individual categories. The percentage of steps completed correctly was significantly higher in the VR group compared to the SG group (63% vs. 25%, p < 0.002). Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
DISCUSSION


VR training was more effective than a passive SG in our model of simulated tibia IMN for novice medical students. Virtual reality training may be a useful method to augment orthopedic education.",2020,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","['20 participants', 'novice medical students', 'trained novice medical students performing a SawBones simulation of intramedullary nail fixation', 'All 20 participants completed the first phase and 17 completed the second phase of the study', 'First and second-year medical students without prior experience of procedure', 'Tibial Shaft Fracture Intramedullary Nailing']","['VR training', 'Virtual Reality Tool to Teach Surgical Technique', 'simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs', 'Virtual reality training', 'SG or VR training', 'SG']","['Aggregate global assessment scores', 'percentage of steps completed correctly']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",20.0,0.0186146,"Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).
","[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Blumstein', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: gblumstein@mednet.ucla.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zukotynski', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cevallos', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ishmael', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Zoller', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Burke', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Clarkson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bernthal', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nelson F', 'Initials': 'NF', 'LastName': 'SooHoo', 'Affiliation': 'Department of Orthopedic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.01.002']
1145,23241431,Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial.,"BACKGROUND


Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD) is far from satisfactory. Vagus nerve stimulation (VNS) is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response.This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention.
DESIGN


One hundred twenty cases (60 males) of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS) and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period.
DISCUSSION


This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of methodologies in clinical trials of acupuncture treatment.
TRIALS REGISTRATION


Clinical Trials. ChiCTR-TRC-11001201 http://www.chictr.org/cn/",2012,"This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders.","['One hundred twenty cases (60 males) of volunteer patients with mild and moderate depression', 'depression']","['transcutaneous vagus nerve stimulation group (tVNS) and sham tVNS', 'Transcutaneous vagus nerve stimulation', 'VNS', 'Vagus nerve stimulation (VNS']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],120.0,0.201648,"This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders.","[{'ForeName': 'Pei-Jing', 'Initials': 'PJ', 'LastName': 'Rong', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, 100700, China. rongpj@hotmail.com'}, {'ForeName': 'Ji-Liang', 'Initials': 'JL', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ying-ge', 'Initials': 'YG', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ben', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ru-Peng', 'Initials': 'RP', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zhan-Xia', 'Initials': 'ZX', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': ''}]",BMC complementary and alternative medicine,['10.1186/1472-6882-12-255']
1146,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND


No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS


We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS


There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS


Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
1147,31128958,An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina.,"INTRODUCTION


Statins are essential drugs for high cardiovascular disease (CVD) risk management; however, there is still low adherence to good clinical practice guidelines for statin use at the primary care level in low- and middle-income countries. This study aimed to test whether a complex intervention targeting physicians improves treatment and control of hypercholesterolemia among patients with moderate to high CVD risk in Argentina.
STUDY DESIGN


Cluster RCT.
SETTING/PARTICIPANTS


Ten primary care centers from the public healthcare system of Argentina.
INTERVENTION


Primary care physicians in the intervention group received an educational program with three main components: (1) an intensive 2-day training workshop; (2) educational outreach visits; and (3) a mobile health application installed on the physician's smartphones.
MAIN OUTCOME MEASURES


Reduction in mean low-density lipoprotein cholesterol level, reduction in mean Framingham risk score, proportion of patients receiving an appropriate statin dose, and mean annual number of primary care center visits.
RESULTS


Data were analyzed in 2017-2018. Between April 2015 and April 2016, a total of 357 participants were enrolled (179 patients in the intervention group and 178 in the control group). The global follow-up rate was 97.2%. At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups. Mean CVD risk had a significant net difference in the first 6 months in the intervention group versus the control group (-4.0, 95% CI = -6.5, -1.5). At the end of follow-up, there was an absolute 41.5% higher rate of participants receiving an appropriate statin dose in the intervention group versus the control group.
CONCLUSIONS


Although the intervention did not reach a reduction in cholesterol levels, it had a significant positive impact on the promotion of adequate use of clinical practice guidelines.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02380911.",2019,"At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups.","['Ten primary care centers from the public healthcare system of Argentina', 'Between April 2015 and April 2016, a total of 357 participants were enrolled (179 patients in the intervention group and 178 in the control group', 'patients with moderate to high CVD risk in Argentina']","[""educational program with three main components: (1) an intensive 2-day training workshop; (2) educational outreach visits; and (3) a mobile health application installed on the physician's smartphones"", 'complex intervention targeting physicians']","['mean low-density lipoprotein cholesterol level, reduction in mean Framingham risk score, proportion of patients receiving an appropriate statin dose, and mean annual number of primary care center visits', 'cholesterol levels', 'low-density lipoprotein cholesterol levels', 'Mean CVD risk']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",357.0,0.055526,"At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups.","[{'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina. Electronic address: pgulayin@iecs.org.ar.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lozada', 'Affiliation': 'Lipid Clinic at Austral University, Pilar, Argentina.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Beratarrechea', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gutierrez', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Poggio', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}, {'ForeName': 'Raúl Martín', 'Initials': 'RM', 'LastName': 'Chaparro', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}, {'ForeName': 'Marilina', 'Initials': 'M', 'LastName': 'Santero', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Masson', 'Affiliation': 'Buenos Aires Italiano Hospital, Ciudad Autónoma de Buenos Aires, Argentina.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Rubinstein', 'Affiliation': 'National Ministry of Health, Buenos Aires, Argentina.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Research in Chronic Diseases Department, Buenos Aires, Argentina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.02.018']
1148,31122792,Parent eReferral to Tobacco Quitline: A Pragmatic Randomized Trial in Pediatric Primary Care.,"INTRODUCTION


Quitlines are effective in helping smokers quit, but pediatrician quitline referral rates are low, and few parents who smoke use the service. This study compared enrollment of parents who smoke in the quitline using electronic referral with that using manual referral.
STUDY DESIGN


The study was designed as a pragmatic RCT.
SETTING/PARTICIPANTS


Participants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families. Participants included adult parents who smoked and were present at their child's healthcare visit.
INTERVENTION


Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (""warm handoff"") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. Data were collected between March 2017 and February 2018 and analyzed in 2018.
MAIN OUTCOME MEASURES


The primary outcome was the proportion of parents enrolled in quitline treatment. Secondary outcomes included parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment. Number of quitline contacts was also explored.
RESULTS


During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6). Parents aged ≥50 years enrolled in the quitline more frequently. Although more parents in the eReferral group connected to the quitline, among parents who had at least one quitline contact, there was no significant difference in the mean number of quitline contacts between eReferral and control groups (mean, 2.04 vs 2.40 calls; difference, 0.36 [95% CI=0.35, 1.06]).
CONCLUSIONS


Smoking parent eReferral from pediatric primary care may increase quitline enrollment and could be adopted by practices interested in increasing rates of parent treatment.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02997735.",2019,"During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6).","['parents who smoke in the quitline using electronic referral with that using manual referral', ""Participants included adult parents who smoked and were present at their child's healthcare visit"", 'Parent eReferral to Tobacco Quitline', 'Participants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families', 'Parents aged ≥50 years enrolled in the quitline more frequently', 'Data were collected between March 2017 and February 2018 and analyzed in 2018']",[],"['proportion of parents enrolled in quitline treatment', 'parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment', 'mean number of quitline contacts']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]",[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.101209,"During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6).","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Jenssen', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Electronic address: jenssenb@email.chop.edu.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Muthu', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Kelly', 'Affiliation': ""PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Baca', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",American journal of preventive medicine,['10.1016/j.amepre.2019.03.005']
1149,32423247,Effect of Nasal Steroids on Nasal Obstruction in Septal Deviation: A Double-Blind Randomized Controlled Trial.,"Objective:  This study sought to prospectively determine the effect of intranasal steroids versus placebo on nasal obstruction in septal deviation.  Methods:  This was a single-center randomized placebo-controlled double-blind trial with crossover in which all study participants received 6 weeks of therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher). Participants were randomized to one of two groups with a 2-week washout period between drugs. Nasal Obstruction Symptom Evaluation (NOSE) scores were collected at baseline and after each study drug. A subset of patients subsequently underwent surgical intervention after both drugs and additional NOSE scores were collected postoperatively.  Results:  Forty-two patients completed both study drugs with NOSE scores collected. Thirty-two patients underwent surgery and postoperative NOSE scores were collected. There was no significant difference in baseline demographics between the groups. There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs. There was no difference in the change in mean NOSE score from baseline to postsaline (-3.9) versus baseline to poststeroid (-5.8,  p  = 0.60). Surgery resulted in a significant change in NOSE score at all postoperative time points (mean of -50, range of -47.2 to -53.6).  Conclusions:  We found no significant effect of intranasal steroids on nasal obstruction as compared with placebo. Surgery, however, was associated with significant sustained improvement in nasal obstruction. These data suggest that in patients with nasal obstruction due to a fixed cause, medical therapy with intranasal steroids is unlikely to be beneficial.",2020,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"['Nasal Obstruction in Septal Deviation', 'patients with nasal obstruction', 'Results:  Forty-two patients completed both study drugs with NOSE scores collected']","['intranasal steroids', 'intranasal steroids versus placebo', 'Nasal Steroids', 'therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher', 'placebo']","['mean NOSE scores', 'mean NOSE score', 'NOSE score', 'baseline demographics', 'Nasal Obstruction Symptom Evaluation (NOSE) scores', 'nasal obstruction', 'postoperative NOSE scores']","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0594040', 'cui_str': 'Nasacort'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",42.0,0.347848,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"[{'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': 'Rudy', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Kandathil', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Spataro', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Sami P', 'Initials': 'SP', 'LastName': 'Moubayed', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Montreal, Montréal, Canada.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0150']
1150,31399438,Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial.,"OBJECTIVE


To explore gallbladder- and biliary tract-related events reported for the liraglutide and placebo groups in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial.
RESEARCH DESIGN AND METHODS


LEADER was an international, randomized, double-blind, controlled cardiovascular (CV) outcomes trial. Participants with type 2 diabetes at high risk for CV events ( n  = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily;  n  = 4,668) or placebo ( n  = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years). Acute gallstone disease was a medical event of special interest. This post hoc analysis categorized captured events of acute gallbladder or biliary disease into four groups: uncomplicated gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction. Time to first event by treatment group was analyzed using Cox regression.
RESULTS


There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n  = 141 of 4,668 vs.  n  = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09;  P  < 0.001). Similar trends were observed for each of the four categories of gallbladder- or biliary tract-related events. Cholecystectomy was performed more frequently in liraglutide-treated patients (HR 1.56; 95% CI 1.10, 2.20;  P  = 0.013) but for similar proportions of the patients who experienced gallbladder- or biliary tract-related events (57% with liraglutide vs. 59% with placebo).
CONCLUSIONS


Although LEADER was not specifically designed to assess acute gallbladder or biliary disease, the trial showed an increased risk of gallbladder- or biliary tract-related events with liraglutide versus placebo, which appeared to be consistent across four categories of these events. Further studies should investigate the relevant mechanisms.",2019,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n  = 141 of 4,668 vs.  n  = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09;  P  < 0.001).","['Participants with type 2 diabetes at high risk for CV events ( n  = 9,340', 'Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Liraglutide', 'liraglutide', 'liraglutide and placebo', 'placebo', 'Placebo', 'liraglutide versus placebo']","['gallbladder- or biliary tract-related events', 'risk of acute gallbladder or biliary disease', 'gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction', 'Acute Gallbladder or Biliary Disease']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0005423', 'cui_str': 'Biliary System'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0008325', 'cui_str': 'Gallbladder Inflammation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",4672.0,0.459866,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n  = 141 of 4,668 vs.  n  = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09;  P  < 0.001).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Muus Ghorbani', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0415']
1151,32423509,Consumer perception and behaviour related to low-alcohol wine: do people overcompensate?,"OBJECTIVE


Compared with standard wines, low-alcohol wines may have several social and health benefits. Innovative production processes have led to high-quality light wines. It is, however, unclear how consumers perceive and consume these alcohol-reduced wines. The current study aimed to investigate how people evaluate low-alcohol wine (Sauvignon Blanc) and if the reduction in alcohol and the information that a wine is low in alcohol influences consumption.
DESIGN


Randomised controlled trial (RCT).
SETTING


Participants were invited to a wine tasting and randomised into one of the three conditions: they either tasted a 'new white wine' (12·5 % alcohol content), a 'new low-alcohol white wine' (8·0 % alcohol content) or they tasted the low-alcohol wine but were not aware that the wine was reduced in alcohol (low-alcohol, blinded).
PARTICIPANTS


Ninety participants (42 % male, mean age = 41 (sd 14) years).
RESULTS


Mean comparisons showed similar ratings for the low-alcohol conditions and the standard alcohol condition (mean > 5·6/7). The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol. However, participants were willing to pay more for the normal wine compared with the low-alcohol wine, (F2,87 = 3·14, P < 0·05).
CONCLUSIONS


Participants did not alter their drinking behaviour in response to the reduced alcohol content, and the low-alcohol wine was perceived positively. There might be an emerging market potential for wine of reduced alcohol content, but consumers may not be willing to pay the same price as for the standard wine.",2020,"The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol.","['Ninety participants (42 % male, mean age = 41', 'Participants were invited to a wine tasting and randomised into one of the three conditions: they either']","[""tasted a 'new white wine' (12·5 % alcohol content), a 'new low-alcohol white wine' (8·0 % alcohol content) or they tasted the low-alcohol wine but were not aware that the wine was reduced in alcohol (low-alcohol, blinded""]",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0349372', 'cui_str': 'White wine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0452483', 'cui_str': 'Low alcohol wine'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",[],90.0,0.023985,"The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bucher', 'Affiliation': 'School of Environmental and Life Science, Faculty of Science, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Frey', 'Affiliation': 'School of Environmental and Life Science, Faculty of Science, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wilczynska', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Deroover', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dohle', 'Affiliation': 'Social Cognition Center Cologne, University of Cologne, 50931Köln, Germany.'}]",Public health nutrition,['10.1017/S1368980019005238']
1152,31540903,"Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial.","OBJECTIVE


To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).
RESEARCH DESIGN AND METHODS


Patients with T2D ( n  = 84) (HbA 1c  6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.
RESULTS


EMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2;  P  = 0.02) and relative change in LFC of -22% (-36, -7;  P  = 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42];  P  < 0.001) and high-molecular-weight adiponectin (36% [16, 60];  P  < 0.001) levels from 0 to 24 weeks.
CONCLUSIONS


EMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D.",2020,"Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4 kg];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed.","['Well-Controlled Type 2 Diabetes', 'Patients with T2D ( n  = 84) (HbA 1c  6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months', 'patients with T2D with excellent glycemic control and short known disease duration']","['Placebo', 'EMPA', 'EMPA (placebo', 'EMPA or placebo', 'sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA', 'Empagliflozin']","['change in LFC', 'insulin sensitivity and liver function', 'uric acid', 'hepatic fat', 'high-molecular-weight adiponectin', 'circulating uric acid and raises adiponectin levels', 'Tissue-specific insulin sensitivity', 'liver fat content (LFC', 'tissue-specific insulin sensitivity', 'Liver Fat Content', 'Weight loss']","[{'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin (substance)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.629387,"Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4 kg];  P  < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed.","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Straßburger', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Hisayuki', 'Initials': 'H', 'LastName': 'Katsuyama', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kabisch', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Henkel', 'Affiliation': 'Clinical Study Center of Metabolic Vascular Medicine, GWT-TUD GmbH, Dresden, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kopf', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Lagerpusch', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Kupriyanova', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Markgraf', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'van Gemert', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Knebel', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Wolkersdorfer', 'Affiliation': 'Landesapotheke Salzburg, Salzburg, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kuss', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Paul Langerhans Institute Dresden, Helmholtz Center Munich at University Hospital MKIII, and Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kasperk', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Stefan', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pfeiffer', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany michael.roden@ddz.de.'}]",Diabetes care,['10.2337/dc19-0641']
1153,32422244,"Implementation of basic life support training for school children: Online education for potential instructors? Results of a cluster randomised, controlled, non-inferiority trial.","AIM OF THE STUDY


Comprehensive training of the population in basic life support (BLS) increases the chance of survival in cardiac arrest. To implement BLS trainings at schools a high number of instructors will be needed. This non-inferiority study investigated, if online education is effective to prepare instructors to teach BLS compared to face-to-face education.
METHODS


A cluster randomised, controlled, single blinded study was performed in 2018 in Hamburg, Germany. A mixed group of potential instructors were allocated alternately to either the intervention or control group and participated in a four-hour instructor training. The instructor training of the control group was realised by trained educators. The intervention group participated in a self-regulated online training with hands-on training supported by peers. Instructors provided BLS training for high school students. The primary endpoint was a mean score in the BLS skills assessment of the students. The secondary endpoint was teaching effectiveness of the instructors.
RESULTS


BLS assessments of 808 students of 46 classes, who were taught by 74 instructors could be analysed. The students trained by interventional instructors achieved 0.14 points less (95% CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48). The non-inferiority could not be confirmed. The teaching performance in the intervention group was better in some aspects compared to the control group.
CONCLUSION


Integrating all results of this study, online education may be an effective alternative to prepare potential BLS instructors. Using free online courses, motivated persons can independently acquire necessary skills to become instructors and autonomously realise low cost BLS trainings at schools.",2020,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"['808 students of 46 classes, who were taught by 74 instructors could be analysed', '2018 in Hamburg, Germany', 'high school students', 'school children']","['Basic life support training', 'BLS training', 'self-regulated online training with hands-on training supported by peers', 'intervention or control group and participated in a four-hour instructor training']","['mean score in the BLS skills assessment of the students', 'teaching effectiveness of the instructors']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",,0.042077,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kosan', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hoffend', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Breitfeld', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany. Electronic address: st.beck@uke.de.'}]",Resuscitation,['10.1016/j.resuscitation.2020.04.041']
1154,31539295,Negative Hyperselection of Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer Who Received Panitumumab-Based Maintenance Therapy.,"PURPOSE


We assessed the prognostic/predictive role of primary tumor sidedness and uncommon alterations of anti-epidermal growth factor receptor (EGFR) primary resistance (primary resistance in  RAS  and  BRAF  wild-type metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC) who were randomly assigned to panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino trial (ClinicalTrials.gov identifier: NCT02476045).
PATIENTS AND METHODS


This prespecified retrospective analysis included 199 evaluable patients with  RAS / BRAF  wt. The PRESSING panel included the following: immunohistochemistry (IHC) and in situ hybridization for  HER2/MET  amplification, IHC with or without RNA sequencing for  ALK/ROS1/NTRKs/RET  fusions, next-generation sequencing for  HER2 / PIK3CAex.20/PTEN / AKT1  and  RAS  mutations with low mutant allele fraction, and multiplex polymerase chain reaction for microsatellite instability. PRESSING status (any positive biomarker  v  all negative) and sidedness were correlated with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the study population and by treatment arm.
RESULTS


Overall, left- and right-sided tumors were 85.4% and 14.6%, respectively, and PRESSING-negative and -positive tumors were 75.4% and 24.6%, respectively. At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062). Similar results were observed in the PRESSING-positive versus PRESSING-negative subgroup for ORR (59.2%  v  75.3%;  P  = .030), PFS (7.7  v  12.1 months;  P  < .001), and OS (2-year rate: 48.1%  v  68.1%;  P  = .021). The PFS benefit of FU plus LV added to panitumumab maintenance, reported in the study, was independent from sidedness and PRESSING status (interaction for PFS  P  = .293 and .127, respectively). However, outcomes were extremely poor in patients who received single-agent panitumumab and had right-sided tumors (median PFS, 7.7 months; 2-year OS, 38.5%) or PRESSING-positive tumors (median PFS, 7.4 months; 2-year OS, 47.0%).
CONCLUSION


The combined assessment of sidedness and molecular alterations of anti-EGFR primary resistance identified a consistent proportion of patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs.",2019,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","['199 evaluable patients with  RAS / BRAF  wt', 'Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer', 'patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs', 'metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC']","['Panitumumab-Based Maintenance Therapy', 'panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino']","['Overall, left- and right-sided tumors', 'overall response rate (ORR), progression-free survival (PFS), and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",199.0,0.168706,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Murialdo', 'Affiliation': 'University of Genoa and IRCCS Azienda Ospedaliera Universitaria (AOU) San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Azienda Socio-Sanitaria Territoriale Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Racca', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Gloghini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palermo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milione', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01254']
1155,31916571,The proliferative phase endometrium in IVF/ICSI: an in-cycle molecular analysis predictive of the outcome following fresh embryo transfer.,"STUDY QUESTION


Does an early proliferative phase endometrial biopsy harvested during ovarian stimulation harbour information predictive of the outcome following fresh embryo transfer (ET) in that same cycle?
SUMMARY ANSWER


Transcriptome analysis of the whole-tissue endometrium did not reveal significant differential gene expression (DGE) in relation to the outcome; however, the secretome profile of isolated, cultured and in vitro decidualized endometrial stromal cells (EnSCs) varied significantly between patients who had a live birth compared to those with an implantation failure following fresh ET in the same cycle as the biopsy.
WHAT IS KNOWN ALREADY


In the majority of endometrial receptivity research protocols, biopsies are harvested during the window of implantation (WOI). This, however, precludes ET in that same cycle, which is preferable as the endometrium has been shown to adapt over time. Endometrial biopsies taken during ovarian stimulation have been reported not to harm the chances of implantation, and in such biopsies DGE has been observed between women who achieve pregnancy versus those who do not. The impact of the endometrial proliferative phase on human embryo implantation remains unclear, but deserves further attention, especially since in luteal phase endometrial biopsies, a transcriptional signature predictive for repeated implantation failure has been associated with reduced cell proliferation, possibly indicating proliferative phase involvement. Isolation, culture and in vitro decidualization (IVD) of EnSCs is a frequently applied basic research technique to assess endometrial functioning, and a disordered EnSC secretome has previously been linked with failed implantation.
STUDY DESIGN, SIZE, DURATION


This study was nested in a randomized controlled trial (RCT) investigating the effect of endometrial scratching during the early follicular phase of ovarian stimulation on clinical pregnancy rates after IVF/ICSI. Of the 96 endometrial biopsies available, after eliminating those without fresh ET and after extensive matching in order to minimize the risk of potential confounding, 18 samples were retained to study two clinical groups: nine biopsies of patients with a live birth versus nine biopsies of patients with an implantation failure, both following fresh ET performed in the same cycle as the biopsy. We studied the proliferative endometrium by analysing its transcriptome and by isolating, culturing and decidualizing EnSCs in vitro. We applied this latter technique for the first time on proliferative endometrial biopsies obtained during ovarian stimulation for in-cycle outcome prediction, in an attempt to overcome inter-cycle variability.
PARTICIPANTS/MATERIALS, SETTING, METHODS


RNA-sequencing was performed for 18 individual whole-tissue endometrial biopsies on an Illumina HiSeq1500 machine. DGE was analysed three times using different approaches (DESeq2, EdgeR and the Wilcoxon rank-sum test, all in R). EnSC isolation and IVD was performed (for 2 and 4 days) for a subset of nine samples, after which media from undifferentiated and decidualized cultures were harvested, stored at -80°C and later assayed for 45 cytokines using a multiplex suspension bead immunoassay. The analysis was performed by partial least squares regression modelling.
MAIN RESULTS AND THE ROLE OF CHANCE


After correction for multiple hypothesis testing, DGE analysis revealed no significant differences between endometrial samples from patients who had a live birth and those with an implantation failure following fresh ET. However secretome analysis after EnSC isolation and culture, showed two distinct clusters that clearly corresponded to the two clinical groups. Upon IVD, the secretome profiles shifted from that of undifferentiated cells but the difference between the two clinical groups remained yet were muted, suggesting convergence of cytokine profiles after decidualization.
LIMITATIONS, REASONS FOR CAUTION


Caution is warranted due to the limited sample size of the study and the in vitro nature of the EnSC experiment. Validation on a larger scale is necessary, however, hard to fulfil given the very limited availability of in-cycle proliferative endometrial biopsies outside a RCT setting.
WIDER IMPLICATIONS OF THE FINDINGS


These data support the hypothesis that the endometrium should be assessed not only during the WOI and that certain endometrial dysfunctionalities can probably be detected early in a cycle by making use of the proliferative phase. This insight opens new horizons for the development of endometrial tests, whether diagnostic or predictive of IVF/ICSI treatment outcome.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by Fonds Wetenschappelijk Onderzoek (FWO, Flanders, Belgium, 11M9415N, 1 524 417N), Wetenschappelijk Fonds Willy Gepts (WFWG G160, Universitair Ziekenhuis Brussel, Belgium) and the National Medicine Research Council (NMRC/CG/M003/2017, Singapore). There are no conflicts of interests.
TRIAL REGISTRATION NUMBER


NCT02061228.",2020,"Transcriptome analysis of the whole-tissue endometrium did not reveal significant differential gene expression (DGE) in relation to the outcome; however, the secretome profile of isolated, cultured and in vitro decidualized endometrial stromal cells (EnSCs) varied significantly between patients who had a live birth compared to those with an implantation failure following fresh ET in the same cycle as the biopsy.
",['RNA-sequencing was performed for 18 individual whole-tissue endometrial biopsies on an Illumina HiSeq1500 machine'],"['ICSI', 'fresh embryo transfer (ET', 'IVF', 'IVF/ICSI']",['clinical pregnancy rates'],"[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1510477', 'cui_str': 'Endometrial biopsy (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",96.0,0.0995445,"Transcriptome analysis of the whole-tissue endometrium did not reveal significant differential gene expression (DGE) in relation to the outcome; however, the secretome profile of isolated, cultured and in vitro decidualized endometrial stromal cells (EnSCs) varied significantly between patients who had a live birth compared to those with an implantation failure following fresh ET in the same cycle as the biopsy.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Daneels', 'Affiliation': 'Centre for Medical Genetics, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Department of Pathology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Essahib', 'Affiliation': 'Research group Reproduction and Immunology (REIM), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Verpoest', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bourgain', 'Affiliation': 'Research group Reproduction and Immunology (REIM), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Van Riet', 'Affiliation': 'Department of Hematology and Immunology, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Brosens', 'Affiliation': 'Division of Biomedical Sciences, Clinical Science Research Laboratories, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': ""KK Research Centre, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Van de Velde', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez218']
1156,31916574,A comparison of the effects of oral contraceptives on the clinical and biochemical manifestations of polycystic ovary syndrome: a crossover randomized controlled trial.,"STUDY QUESTION


Do oral contraceptives (OCs) containing progestins with low androgenic or antiandrogenic activities have different effects to those containing levonorgestrel (LNG) on clinical, androgenic and metabolic manifestations of polycystic ovarian syndrome (PCOS)?
SUMMARY ANSWER


The three OCs tested had similar effects on clinical findings of hyperandrogenism (HA), whereas products containing LNG were less effective on androgenic profiles and had detrimental effects on lipid profiles.
WHAT IS KNOWN ALREADY


Despite data available on the effects of OCs, the superiority of products with low androgenic or antiandrogenic progesterone components in comparison with older products used in women with PCOS has not been clarified.
STUDY DESIGN, SIZE, DURATION


This study is a crossover randomized controlled six-arm trial, with all six arms including two 6-month treatment periods, one period with OCs containing LNG, and the other with one of three OCs containing desogestrel (DSG), cyproterone acetate (CPA) or drospirenone (DRSP). The trial was conducted between February 2016 and January 2018 and enrolled 200 patients with PCOS.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Two hundred women with PCOS (ages 18-45 years) were recruited at the endocrine outpatient clinic of the Research Institute for Endocrine Sciences (RIES) of the Shahid Beheshti University of Medical Sciences, Tehran, Iran. A blocking or stratification random allocation (block size = 6) using a computer-based random number generator was prepared to assign participants to treatment groups. Both the clinical examiner and data analyst were blinded to participants during the trial. Outcomes of interest, including anthropometric and clinical manifestations and hormonal, and biochemical parameters were assessed at baseline, after 3 and 6 months of each treatment and after the washout period.
MAIN RESULTS AND THE ROLE OF CHANCE


This study detected a higher decrease in free-androgen index (FAI) levels after 3 months of treatment with OCs containing DSG (95% CI: -2.3, -1.0), CPA (95% CI: -2.4, -1.1) and DRSP (95% CI: -2.6, -1.4), compared with products containing LNG (P < 0.001). Use of OCs containing DSG (95% CI: -3.6, -1.5), CPA (95% CI: -3.1, -0.8) and DRSP (95% CI: -3.4, -1.1) for 6 months was associated with more decrease in FAI, compared with products containing LNG (P < 0.001). The study showed that use of OCs containing DSG, CPA and DRSP for 3-6 months was associated with a higher increase of sex hormone-binding globulin (SHBG), compared with products containing LNG (P < 0.001). We also observed more decrease in dehydroepiandrosterone sulfate levels after use of OCs containing DSG (P = 0.003), CPA (P = 0.012) and DRSP (P < 0.001) for 6 months, compared with products containing LNG. Our results showed that the use of OCs containing DRSP for 6 months was associated with more improvement in acne, compared with products containing LNG (P = 0.007). Women treated with OCs containing CPA, and DRSP for 3 months had higher TG and HDL levels and lower LDL levels, compared with those treated with products containing LNG (P < 0.05). After 6 months of treatment, patients treated with OCs containing DRSP had a sharper decline in LDL levels and more increase in HDL levels, compared to those treated with products containing LNG (P = 0.001).
LIMITATIONS, REASONS FOR CAUTION


Considering this trial was conducted in women diagnosed with Androgen Excess Society criteria, the results may not be generalizable for mild phenotypes diagnosed using Rotterdam criteria. Other limitations of the study include the high dropout rate, the lack of a gold standard androgen assay and the multiple end points.
WIDER IMPLICATIONS OF THE FINDINGS


Our results support the views of clinicians, who suggest an OC with a low androgenic or antiandrogenic progestin, if available, to treat PCOS.
STUDY FUNDING/COMPETING INTEREST(S)


This study was supported by the RIES, Shahid Beheshti University of Medical Sciences, Tehran, Iran. There are no conflicts of interest.
TRIAL REGISTRATION NUMBER


IRCT201702071281N2.
TRIAL REGISTRATION DATE


21 February 2017.
DATE OF FIRST PATIENT’S ENROLMENT


21 March 2017.",2020,"This study detected a higher decrease in free-androgen index (FAI) levels after 3 months of treatment with OCs containing DSG (95% CI: -2.3, -1.0), CPA (95% CI: -2.4, -1.1) and DRSP (95% CI: -2.6, -1.4), compared with products containing LNG (P < 0.001).","['Two hundred women with PCOS (ages 18-45\xa0years) were recruited at the endocrine outpatient clinic of the Research Institute for Endocrine Sciences (RIES) of the Shahid Beheshti University of Medical Sciences, Tehran, Iran', 'February 2016 and January 2018 and enrolled 200 patients with PCOS', '21 February 2017', 'polycystic ovary syndrome', 'women diagnosed with Androgen Excess Society criteria']","['OCs containing LNG', 'OCs containing DRSP', 'oral contraceptives', 'OCs containing CPA, and DRSP', 'OCs containing desogestrel (DSG), cyproterone acetate (CPA) or drospirenone (DRSP', 'levonorgestrel (LNG']","['androgenic profiles', 'FAI', 'higher TG and HDL levels and lower LDL levels', 'sex hormone-binding globulin (SHBG', 'dehydroepiandrosterone sulfate levels', 'free-androgen index (FAI) levels', 'HDL levels', 'LDL levels', 'anthropometric and clinical manifestations and hormonal, and biochemical parameters']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0235461', 'cui_str': 'Androgen excess'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0056855', 'cui_str': 'Cyproterone Acetate'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0853085', 'cui_str': 'Decreased LDL'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0201983', 'cui_str': 'Dehydroepiandrosterone sulfate level'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",200.0,0.231076,"This study detected a higher decrease in free-androgen index (FAI) levels after 3 months of treatment with OCs containing DSG (95% CI: -2.3, -1.0), CPA (95% CI: -2.4, -1.1) and DRSP (95% CI: -2.6, -1.4), compared with products containing LNG (P < 0.001).","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nahidi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Bidhendi-Yarandi', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tohidi', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ramezani Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez255']
1157,22292592,Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long-term oxygen therapy.,"Lightweight ambulatory oxygen devices are provided on the assumptions that they enhance compliance and increase activity, but data to support these assumptions are lacking. We studied 22 patients with severe chronic obstructive pulmonary disease receiving long-term oxygen therapy (14 men, average age = 66.9 y, FEV(1) = 33.6%pred, PaO(2) at rest = 51.7 torr) who were using E-cylinders as their portable oxygen. Subjects were recruited at 5 sites and studied over a 2-week baseline period and for 6 months after randomizing them to either continuing to use 22-lb E-cylinders towed on a cart or to carrying 3.6-lb aluminum cylinders. Utilizing novel electronic devices, ambulatory and stationary oxygen use was monitored continuously over the 2 weeks prior to and the 6 months following randomization. Subjects wore tri-axial accelerometers to monitor physical activity during waking hours for 2-3 weeks prior to, and at 3 and 6 months after, randomization. Seventeen subjects completed the study. At baseline, subjects used 17.2 hours of stationary and 2.5 hours of ambulatory oxygen daily. At 6 months, ambulatory oxygen use was 1.4 ± 1.0 hrs in those randomized to E-cylinders and 1.9 ± 2.4 hrs in those using lightweight oxygen (P = NS). Activity monitoring revealed low activity levels prior to randomization and no significant increase over time in either group. In this group of severe chronic obstructive pulmonary disease patients, providing lightweight ambulatory oxygen did not increase either oxygen use or activity. Future efforts might focus on strategies to encourage oxygen use and enhance activity in this patient group. This trial is registered at ClinicalTrials.gov (NCT003257540).",2012,"In this group of severe chronic obstructive pulmonary disease patients, providing lightweight ambulatory oxygen did not increase either oxygen use or activity.","['COPD patients receiving long-term oxygen therapy', 'Seventeen subjects completed the study', '22 patients with severe chronic obstructive pulmonary disease receiving long-term oxygen therapy (14 men, average age = 66.9 y, FEV(1) ', 'severe chronic obstructive pulmonary disease patients']","['lightweight ambulatory oxygen', 'continuing to use 22-lb E-cylinders towed on a cart or to carrying 3.6-lb aluminum cylinders']","['oxygen use and activity patterns', 'low activity levels', 'oxygen use or activity']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0418996', 'cui_str': 'Ltot - long-term oxygen therapy'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",22.0,0.0265273,"In this group of severe chronic obstructive pulmonary disease patients, providing lightweight ambulatory oxygen did not increase either oxygen use or activity.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Rehabilitation Clinical Trials Center, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, USA. casaburi@ucla.edu'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Porszasz', 'Affiliation': ''}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hecht', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tiep', 'Affiliation': ''}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Anthonisen', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': ''}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dransfield', 'Affiliation': ''}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': ''}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Make', 'Affiliation': ''}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'McEvoy', 'Affiliation': ''}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Niewoehner', 'Affiliation': ''}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reilly', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scanlon', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': ''}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': ''}, {'ForeName': 'Prescott', 'Initials': 'P', 'LastName': 'Woodruff', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",COPD,['10.3109/15412555.2011.630048']
1158,32422373,Add-On Omalizumab for Inadequately Controlled Severe Pollinosis Despite Standard-of-Care: A Randomized Study.,"BACKGROUND


Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven to be effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted.
OBJECTIVE


To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study.
METHODS


Adult/adolescent patients with severe CP whose symptoms were inadequately controlled despite nasal corticosteroids plus 1 or more oral medications in the previous 2 seasons were randomized to receive omalizumab (n = 162) or placebo (n = 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality of life (QoL), and safety.
RESULTS


The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (least squares mean difference, -1.03, P < .001) and ocular (-0.87, P < .001) symptom scores compared with SoC + placebo, respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC + omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed.
CONCLUSIONS


In patients with severe CP, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well tolerated. These results indicate that omalizumab could be a promising therapeutic option for severe CP/AR.",2020,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","['Severe adult/adolescent CP patients whose symptoms were inadequately controlled despite nasal corticosteroids plus one or more oral medications in the previous two seasons', 'Cedar pollinosis (CP', 'patients with inadequately controlled severe CP']","['Omalizumab (anti-IgE therapy', 'concomitant antihistamines and nasal corticosteroids as SoC', 'SoC + Omalizumab', 'omalizumab', 'SoC + placebo', 'placebo']","['individual components of nasal and ocular symptoms', 'QoL scores', 'mean ocular symptom score, quality-of-life, and safety', 'mean nasal symptom score']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",175.0,0.216499,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","[{'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Nippon Medical School, Tokyo, Japan. Electronic address: ent-kimi@nms.ac.jp.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Okano', 'Affiliation': 'Department of Otorhinolaryngology, International University of Health and Welfare School of Medicine, Narita, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tamaki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Alkaz', 'Initials': 'A', 'LastName': 'Uddin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.068']
1159,32423621,Clinical Outcomes of Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy in Men With Oligometastatic Recurrence of Prostate Cancer.,"AIMS


Stereotactic body radiotherapy (SBRT) with the delayed option of androgen deprivation therapy (ADT) is the current treatment paradigm in men relapsed with oligometastatic prostate cancer based on the outcome of a phase II randomised controlled study. The immediate (concomitant) use of ADT in this clinical setting potentially augments the efficacy of SBRT by improving systemic disease control. The aim of this study was to compare the clinical outcomes of these two treatment strategies.
MATERIALS AND METHODS


Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis. Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI) were assessed using Kaplan-Meier and Cox proportional hazard regression methods. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
RESULTS


Thirty-nine patients (44.3%) were treated with SBRT and immediate ADT (continuous ADT, n = 7; intermittent ADT, n = 32) and 49 (55.7%) with SBRT and delayed ADT. The median follow-up was 24 months (interquartile range 13.5-37.0 months). PFS in the immediate and delayed ADT groups were 26 months and 16 months, respectively (P < 0.007). The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025). The 1- and 2-year FFFI in the immediate ADT group were 88% and 64.1%, respectively, significantly higher than those in the delayed ADT group (63.8% and 30.2%, respectively, P < 0.002). Acute toxicities of grade 1-2 occurred in 17.9% of the immediate ADT group and 18.4% of the delayed ADT group (P = 0.96). Only one case of grade 3 late toxicity (pelvic insufficiency) was identified in this study.
CONCLUSIONS


SBRT with concomitant ADT improves PFS, WFFS and FFFI as compared with SBRT with delayed ADT; this finding needs validation in a prospective, randomised study.",2020,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"['men relapsed with oligometastatic prostate cancer', 'Men With Oligometastatic Recurrence of Prostate Cancer', 'Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis']","['Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy', 'androgen deprivation therapy (ADT', 'SBRT and immediate ADT', 'SBRT with delayed ADT', 'SBRT with concomitant ADT', 'Stereotactic body radiotherapy (SBRT']","['PFS', 'grade 3 late toxicity (pelvic insufficiency', '1- and 2-year FFFI', 'Acute toxicities of grade 1-2', 'median WFFS', 'Toxicity', 'Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI', 'PFS, WFFS and FFFI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",88.0,0.0423596,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Chaw', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK. Electronic address: 0109061c@doctors.org.uk.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Cancer Research UK Imaging Centre, The Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Suh', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.03.008']
1160,31518645,Novel Disease Risk Model for Patients with Acute Myeloid Leukemia Receiving Allogeneic Hematopoietic Cell Transplantation.,"Molecular data and minimal residual disease (MRD) have been shown to influence outcomes in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (AHCT). Here we developed and validated a novel AML-specific disease risk group (AML-DRG) and revised our previously developed hematopoietic cell transplant-composite risk (HCT-CR) model by incorporating molecular data and MRD status to predict outcomes of patients with AML. The study included 1414 consecutively treated adult AML patients who received a first AHCT. Patients were randomly assigned into training (n = 944) and validation (n = 470) sets. To develop the AML-DRG model, the coefficient of all significant AML-related variables in multivariable Cox regression analysis in a training dataset was converted into scores, whereas the AML-HCT-CR was the sum of disease-related factors assessed by the AML-DRG model with the addition of weighted scores from patient-related factors. The AML-DRG was developed by assigning the following scores: 1 point to secondary AML, 1 point to the European LeukaemiaNet adverse genetic risk, 2 points to complete remission with MRD positive/unknown, and 4 points to active disease. These scores were used to generate 3 risk groups of the AML-DRG with significantly different overall survivals. By adding the score for significant patient-related factors (HCT-specific comorbidity index/age), we created 4 risk groups of AML-HCT-CR with distinct survival outcomes. Both the AML-DRG and AML-HCT-CR provided significantly better discriminative capacity compared with the disease risk index, European LeukaemiaNet genetic risk model, and cytogenetic risk model. Prognostic models incorporating molecular data and MRD status allow better stratification and improved survival estimates of AML patients post-transplant.",2020,"Both the AML-DRG and AML-HCT-CR provided significantly better discriminative capacity compared with the disease risk index, European LeukaemiaNet genetic risk model, and cytogenetic risk model.","['1414 consecutively treated adult AML patients who received a first AHCT', 'patients with AML', 'acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (AHCT', 'Patients with Acute Myeloid Leukemia']",['Allogeneic Hematopoietic Cell Transplantation'],"['AML-DRG', 'overall survivals', 'survival estimates']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0011928', 'cui_str': 'DRG'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",1414.0,0.0266514,"Both the AML-DRG and AML-HCT-CR provided significantly better discriminative capacity compared with the disease risk index, European LeukaemiaNet genetic risk model, and cytogenetic risk model.","[{'ForeName': 'Piyanuch', 'Initials': 'P', 'LastName': 'Kongtim', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas; Center of Excellence in Applied Epidemiology, Thammasat University, Pathumthani, Thailand; Department of Medicine Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hasan', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jorge Miguel Ramos', 'Initials': 'JMR', 'LastName': 'Perez', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Varma', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sa A', 'Initials': 'SA', 'LastName': 'Wang', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Keyur P', 'Initials': 'KP', 'LastName': 'Patel', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rondon', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Srour', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Qaiser', 'Initials': 'Q', 'LastName': 'Bashir', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Muzaffar', 'Initials': 'M', 'LastName': 'Qazilbash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rohtesh', 'Initials': 'R', 'LastName': 'Mehta', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Alousi', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Khouri', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Popat', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Champlin', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Stefan O', 'Initials': 'SO', 'LastName': 'Ciurea', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: sciurea@mdanderson.org.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.09.006']
1161,20855467,Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma.,"BACKGROUND


Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®)) is made by covalently conjugating the essential fatty acid DHA to the paclitaxel molecule. Preclinical studies of DHA-paclitaxel have demonstrated increased activity relative to paclitaxel and the potential for an improved therapeutic ratio. In the present study, the efficacy and toxicity profiles of DHA-paclitaxel were compared with those of dacarbazine.
METHODS


In this study, 393 chemonaive patients with metastatic melanoma were randomly assigned to receive either DHA-paclitaxel at a starting dose of 900 mg/m(2) IV on day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m(2) IV on day 1 every 3 weeks. The primary end point of the study was the comparison of overall survival (OS).
RESULTS


No significant difference in OS was noted between patients in the DHA-paclitaxel and dacarbazine arms. Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs. Safety results of the two drugs were as predicted from prior studies. Myelosuppression was more common with DHA-paclitaxel.
CONCLUSIONS


DHA-paclitaxel was not superior to dacarbazine. We conclude that further studies with the drug on an every 3-week schedule in melanoma are not warranted.",2011,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","['patients with metastatic malignant melanoma', '393 chemonaive patients with metastatic melanoma']","['dacarbazine', 'Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®', 'docosahexaenoic acid-paclitaxel versus dacarbazine', 'DHA-paclitaxel']","['OS', 'Myelosuppression', 'efficacy and toxicity profiles', 'overall survival (OS', 'response rate, duration of response, time to progression, and time to treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860594', 'cui_str': 'Malignant melanoma, metastatic'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1134470', 'cui_str': 'DHA-paclitaxel'}, {'cui': 'C1135143', 'cui_str': 'Taxoprexin'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",393.0,0.327994,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","[{'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Bedikian', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston. Electronic address: abedikia@mdanderson.org.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'DeConti', 'Affiliation': 'Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'Division of Hematology & Oncology, Kirkland Clinic at Acton Road, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agarwala', 'Affiliation': ""Department of Hematology/Oncology, St Luke's Cancer Center, Bethlehem.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ernstoff', 'Affiliation': 'Department of Hematology/Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq438']
1162,32431211,Accurately Reflecting Uncertainty When Using Patient-Level Simulation Models to Extrapolate Clinical Trial Data.,"Introduction.  Patient-level simulation models facilitate extrapolation of clinical trial data while allowing for heterogeneity, prior history, and nonlinearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging.  Methods.  We tested 4 methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these 4 methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomized controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs.  Results.  The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage.  Conclusions.  Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.",2020,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).",[],[],[],[],[],[],,0.0800414,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20916442']
1163,31529450,Does Prepregnancy Weight or Maternal BMI at Betamethasone Administration Impact Late Preterm Respiratory Morbidity?,"OBJECTIVE


We sought to determine if maternal prepregnancy body mass index (BMI) is a risk factor for neonatal respiratory morbidity and to determine if increasing BMI decreased the efficacy of betamethasone (BMZ).
STUDY DESIGN


This was a secondary analysis of the Antenatal Late Preterm Steroids trial, double-blind, randomized controlled trial involving 2,831 women between 34 0/7  and 36 5/7  weeks who received BMZ or a matching placebo. We compared the rate of neonatal respiratory morbidity among prepregnancy BMI classes in both the placebo and treatment groups. We also stratified the treatment effect by maternal BMI at the time of delivery.
RESULTS


A total of 2,822 women were identified with maternal weight recorded at delivery; 2,740 women also had self-reported prepregnancy weight available. When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups. When analyzed by BMI at delivery, there was no difference in the rate of neonatal respiratory morbidity, and BMI was not a predictor of treatment response (odds ratio = 1.00, 95% confidence interval = 0.99-1.02).
CONCLUSION


Maternal prepregnancy BMI is not associated with late preterm neonatal respiratory morbidity. Maternal obesity does not decrease the efficacy of BMZ for preventing late preterm neonatal respiratory morbidity.",2020,"When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups.","['2,822 women were identified with maternal weight recorded at delivery; 2,740 women also had self-reported prepregnancy weight available', '2,831 women between 34 0/7  and 36 5/7  weeks who received']","['placebo', 'BMZ', 'BMZ or a matching placebo', 'betamethasone (BMZ']","['Prepregnancy Weight or Maternal BMI', 'rate of neonatal respiratory morbidity', 'neonatal respiratory morbidity', 'rate of neonatal respiratory morbidity, and BMI']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",2831.0,0.436586,"When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bicocca', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0039-1696644']
1164,32067100,Two-year outcome data suggest that less invasive surfactant administration (LISA) is safe. Results from the follow-up of the randomized controlled AMV (avoid mechanical ventilation) study.,"Less invasive surfactant administration (LISA) is a method to deliver surfactant to spontaneously breathing premature infants via a thin catheter. Here we report the two-year outcome from the AMV (avoid mechanical ventilation) study, the first randomized controlled trial on this mode of surfactant delivery. No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.Conclusion: No differences in outcome were observed at 2 years. LISA seems safe in that aspect. What is Known: • LISA is a method that is in increasing use for surfactant delivery to spontaneously breathing infants. LISA reduces the need for mechanical ventilation. What is New: • Outcome data at 2 years from the first randomized study with LISA raise no safety concerns in comparison to a group of infants that received standard treatment.",2020,"No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.",['spontaneously breathing infants'],"['LISA intervention', 'LISA', 'invasive surfactant administration (LISA']","['weight, length or neurodevelopmental outcome (Bayley II scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0760559,"No statistically significant differences in weight, length or neurodevelopmental outcome (Bayley II scores) were found between the LISA intervention group (n = 95) and the control group (n = 84) that received standard treatment.","[{'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany. egbert.herting@uksh.de.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': 'Department of Neonatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'von der Wense', 'Affiliation': ""Department of Neonatology, Children's Hospital Hamburg-Altona, Hamburg, Germany.""}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Weller', 'Affiliation': 'Department of Paediatrics, Evangelical Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoehn', 'Affiliation': 'Department of Paediatrics, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Department of Neonatology, Olgahospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Möller', 'Affiliation': 'Department of Paediatrics, Saarbrücken General Hospital, Saarbrücken, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': ""Germany Children's Hospital Aschaffenburg-Alzenau, Aschaffenburg, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Department of Neonatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University Hospital of Schleswig-Holstein, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-020-03572-0']
1165,31811825,Effects of Dextrose Gel in Newborns at Risk for Neonatal Hypoglycemia in a Baby-Friendly Hospital.,"OBJECTIVE


To describe the effects of the introduction of dextrose gel to the neonatal hypoglycemia (NH) protocol on exclusive breastfeeding rates at discharge and NICU admission rates among clinically well newborns born at 35 weeks gestation or greater who were at risk for NH in a Baby-Friendly hospital.
DESIGN


Quasi-experimental, pre- and postintervention.
SETTING


A suburban, Baby-Friendly hospital with approximately 2,000 births annually.
PARTICIPANTS


Clinically well newborns born at 35 weeks gestation or greater at risk for NH who were admitted to the mother-baby unit.
METHODS


We compared 198 newborns at risk for NH born in the 6-month period before the introduction of dextrose gel (November 15, 2016, through May 14, 2017) versus 203 newborns born in the 6-month period after the introduction (May 15, 2017, through November 14, 2017). In the preintervention group, the NH protocol included blood glucose monitoring, prolonged skin-to-skin contact, feeding, and dextrose administered intravenously. In the postintervention group, oral dextrose gel was added to the NH protocol.
RESULTS


We found no differences in maternal or newborn characteristics between the pre- and postintervention groups. Dextrose gel was given to 50 newborns (approximately 25%) of 203 in the postintervention group. The proportion of newborns who were exclusively breastfed at discharge was similar between groups (56.6% of 198 vs. 59.1% of 203, p = .62), as were the NICU admission rates for hypoglycemia (2.5% of 198 vs. 1.5% of 203, p = .50).
CONCLUSIONS


In a suburban Baby-Friendly hospital, introduction of dextrose gel into the NH protocol had no significant effect on exclusive breastfeeding at discharge or NICU admission rates.",2020,"In a suburban Baby-Friendly hospital, introduction of dextrose gel into the NH protocol had no significant effect on exclusive breastfeeding at discharge or NICU admission rates.","['Newborns at Risk for Neonatal Hypoglycemia in a Baby-Friendly Hospital', 'Clinically well newborns born at 35\xa0weeks gestation or greater at risk for NH who were admitted to the mother-baby unit', '198 newborns at risk for NH born in the 6-month period before the introduction of dextrose gel (November 15, 2016, through May 14, 2017) versus 203 newborns born in the 6-month period after the introduction (May 15, 2017, through November 14, 2017', 'A suburban, Baby-Friendly hospital with approximately 2,000 births annually', 'clinically well newborns born at 35\xa0weeks gestation or greater who were at risk for NH in a Baby-Friendly hospital']","['dextrose gel', 'Dextrose gel', 'Dextrose Gel', 'oral dextrose gel']","['maternal or newborn characteristics', 'exclusive breastfeeding rates at discharge and NICU admission rates', 'NICU admission rates for hypoglycemia', 'exclusive breastfeeding at discharge or NICU admission rates', 'blood glucose monitoring, prolonged skin-to-skin contact, feeding']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0373031,"In a suburban Baby-Friendly hospital, introduction of dextrose gel into the NH protocol had no significant effect on exclusive breastfeeding at discharge or NICU admission rates.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Stanzo', 'Affiliation': ''}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Arpitha', 'Initials': 'A', 'LastName': 'Chiruvolu', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.11.006']
1166,31812490,Effects of Massage Therapy on Indirect Hyperbilirubinemia in Newborns Who Receive Phototherapy.,"OBJECTIVE


To evaluate the effects of massage therapy on total serum bilirubin (TSB) levels and frequency of defecation, urination, and feeding in newborns who receive phototherapy for indirect hyperbilirubinemia.
DESIGN


A randomized controlled clinical trial.
SETTING


Ankara University Cebeci Research and Training Hospital and 29 May State Hospital in Ankara, Turkey.
PARTICIPANTS


Fifty full-term newborns with indirect hyperbilirubinemia who underwent phototherapy.
METHODS


The newborns were randomly allocated to an intervention group (n = 25) or a control group (n = 25). Newborns in the intervention group received massage therapy throughout the duration of phototherapy for 15 minutes twice per day; newborns in the control group received routine care during phototherapy. Every 24 hours, TSB levels were measured, and the frequencies of defecation, urination, and feeding were also calculated for each newborn.
RESULTS


We found no differences in the characteristics of the newborns or in TSB levels between groups at enrollment. After treatment, TSB levels were lower in the intervention group (p < .001). Frequencies of defecation, urination, and feeding were significantly greater in the intervention group than in the control group.
CONCLUSION


Massage therapy had significant effects on TSB levels, feeding, breastfeeding, defecation, and urination in newborns who received phototherapy for indirect hyperbilirubinemia. Massage therapy can be added as routine care for full-term newborns with hyperbilirubinemia under phototherapy and may be an effective supplementary intervention.",2020,"After treatment, TSB levels were lower in the intervention group (p < .001).","['Fifty full-term newborns with indirect hyperbilirubinemia who underwent phototherapy', 'Ankara University Cebeci Research and Training Hospital and 29 May State Hospital in Ankara, Turkey', 'newborns who receive phototherapy for indirect hyperbilirubinemia', 'Newborns']","['Phototherapy', 'massage therapy', 'routine care during phototherapy', 'phototherapy', 'Massage Therapy', 'Massage therapy']","['total serum bilirubin (TSB) levels and frequency of defecation, urination, and feeding', 'TSB levels', 'TSB levels, feeding, breastfeeding, defecation, and urination', 'Frequencies of defecation, urination, and feeding', 'frequencies of defecation, urination, and feeding', 'Indirect Hyperbilirubinemia']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia (disorder)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020026', 'cui_str': 'Hospitals, State'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1287366', 'cui_str': 'Finding of serum bilirubin level (finding)'}, {'cui': 'C0581872', 'cui_str': 'Frequency of defecation (observable entity)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0268306', 'cui_str': 'Unconjugated hyperbilirubinemia (disorder)'}]",50.0,0.0400376,"After treatment, TSB levels were lower in the intervention group (p < .001).","[{'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Korkmaz', 'Affiliation': ''}, {'ForeName': 'Figen Işık', 'Initials': 'FI', 'LastName': 'Esenay', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.11.004']
1167,31870463,Enzymatically modified isoquercitrin improves endothelial function in volunteers at risk of cardiovascular disease.,"A higher intake of food rich in flavonoids such as quercetin can reduce the risk of CVD. Enzymatically modified isoquercitrin (EMIQ®) has a bioavailability 17-fold higher than quercetin aglycone and has shown potential CVD moderating effects in animal studies. The present study aimed to determine whether acute ingestion of EMIQ® improves endothelial function, blood pressure (BP) and cognitive function in human volunteers at risk of CVD. Twenty-five participants (twelve males and thirteen females) with at least one CVD risk factor completed this randomised, controlled, crossover study. In a random order, participants were given EMIQ® (2 mg aglycone equivalent)/kg body weight or placebo alongside a standard breakfast meal. Endothelial function, assessed by flow-mediated dilatation (FMD) of the brachial artery was measured before and 1·5 h after intervention. BP, arterial stiffness, cognitive function, BP during cognitive stress and measures of quercetin metabolites, oxidative stress and markers of nitric oxide (NO) production were assessed post-intervention. After adjustment for pre-treatment measurements and treatment order, EMIQ® treatment resulted in a significantly higher FMD response compared with the placebo (1·80 (95 % CI 0·23, 3·37) %; P = 0·025). Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo. No changes in BP, arterial stiffness, cognitive function or biochemical parameters were observed. In this human intervention study, the acute administration of EMIQ® significantly increased circulating quercetin metabolites and improved endothelial function. Further clinical trials are required to assess whether health benefits are associated with long-term EMIQ® consumption.",2020,Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo.,"['human volunteers at risk of CVD', 'volunteers at risk of cardiovascular disease', 'Twenty-five participants (twelve males and thirteen females) with at least one CVD risk factor']","['EMIQ® (2 mg aglycone equivalent)/kg body weight or placebo alongside a standard breakfast meal', 'EMIQ®', 'placebo', 'Enzymatically modified isoquercitrin (EMIQ®', 'Enzymatically modified isoquercitrin']","['BP, arterial stiffness, cognitive function or biochemical parameters', 'endothelial function, blood pressure (BP) and cognitive function', 'circulating quercetin metabolites and improved endothelial function', 'Endothelial function, assessed by flow-mediated dilatation (FMD) of the brachial artery', 'Plasma concentrations of quercetin metabolites', 'FMD response', 'endothelial function', 'BP, arterial stiffness, cognitive function, BP during cognitive stress and measures of quercetin metabolites, oxidative stress and markers of nitric oxide (NO) production']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0304518', 'cui_str': 'Aglycone'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0064071', 'cui_str': 'quercetin 3-(beta-D-glucofuranoside)'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0033268'}]",25.0,0.168715,Plasma concentrations of quercetin metabolites were significantly higher (P < 0·001) after EMIQ® treatment compared with the placebo.,"[{'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ward', 'Affiliation': 'School of Public Health and Curtin Health Innovation Research Institute, Curtin University, Perth, 6102 Western Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Centre for Epidemiology and Biostatistics, School of Public Health, FlindersUniversity of South Australia, Adelaide, 5042 South Australia, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Royal Perth Hospital, Perth, 6000 Western Australia, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519002137']
1168,32017867,A pragmatic trial of a group intervention in senior housing communities to increase resilience.,"BACKGROUND


Aging is associated with numerous stressors that negatively impact older adults' well-being. Resilience improves ability to cope with stressors and can be enhanced in older adults. Senior housing communities are promising settings to deliver positive psychiatry interventions due to rising resident populations and potential impact of delivering interventions directly in the community. However, few intervention studies have been conducted in these communities. We present a pragmatic stepped-wedge trial of a novel psychological group intervention intended to improve resilience among older adults in senior housing communities.
DESIGN


A pragmatic modified stepped-wedge trial design.
SETTING


Five senior housing communities in three states in the US.
PARTICIPANTS


Eighty-nine adults over age 60 years residing in independent living sector of senior housing communities.
INTERVENTION


Raise Your Resilience, a manualized 1-month group intervention that incorporated savoring, gratitude, and engagement in value-based activities, administered by unlicensed residential staff trained by researchers. There was a 1-month control period and a 3-month post-intervention follow-up.
MEASUREMENTS


Validated self-report measures of resilience, perceived stress, well-being, and wisdom collected at months 0 (baseline), 1 (pre-intervention), 2 (post-intervention), and 5 (follow-up).
RESULTS


Treatment adherence and satisfaction were high. Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up. Effect sizes were small in this sample, which had relatively high baseline resilience. Physical and mental well-being did not improve significantly, and no significant moderators of change in resilience were identified.
CONCLUSION


This study demonstrates feasibility of conducting pragmatic intervention trials in senior housing communities. The intervention resulted in significant improvement in several measures despite ceiling effects. The study included several features that suggest high potential for its implementation and dissemination across similar communities nationally. Future studies are warranted, particularly in samples with lower baseline resilience or in assisted living facilities.",2020,"Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up.","['senior housing communities to increase resilience', 'senior housing communities', 'Eighty-nine adults over age 60 years residing in independent living sector of senior housing communities', 'Five senior housing communities in three states in the US', 'older adults in senior housing communities', 'older adults']",['novel psychological group intervention'],"['Validated self-report measures of resilience, perceived stress, well-being, and wisdom collected']","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",89.0,0.0653045,"Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up.","[{'ForeName': 'Emily B H', 'Initials': 'EBH', 'LastName': 'Treichler', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Glorioso', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Tsung-Chin', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Sam and Rose Stein Institute for Research on Aging, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Xin M', 'Initials': 'XM', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Mather Institute, Evanston, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Mather Institute, Evanston, IL, USA.'}, {'ForeName': 'Dilip V', 'Initials': 'DV', 'LastName': 'Jeste', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}]",International psychogeriatrics,['10.1017/S1041610219002096']
1169,31580144,Cluster randomised trials with different numbers of measurements at baseline and endline: Sample size and optimal allocation.,"BACKGROUND/AIMS


Published methods for sample size calculation for cluster randomised trials with baseline data are inflexible and primarily assume an equal amount of data collected at baseline and endline, that is, before and after the intervention has been implemented in some clusters. We extend these methods to any amount of baseline and endline data. We explain how to explore sample size for a trial if some baseline data from the trial clusters have already been collected as part of a separate study. Where such data aren't available, we show how to choose the proportion of data collection devoted to the baseline within the trial, when a particular cluster size or range of cluster sizes is proposed.
METHODS


We provide a design effect given the cluster size and correlation parameters, assuming different participants are assessed at baseline and endline in the same clusters. We show how to produce plots to identify the impact of varying the amount of baseline data accounting for the inevitable uncertainty in the cluster autocorrelation. We illustrate the methodology using an example trial.
RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
CONCLUSION


Investigators should think carefully before collecting baseline data in a cluster randomised trial if this is at the expense of endline data. In some scenarios, this will increase the sample size required to achieve given power and precision.",2020,"RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
",[],[],[],[],[],[],,0.33338,"RESULTS


Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation.
","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'Institute for Clinical Trials Methodology, MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774519873888']
1170,32130025,Angiotensin II-mediated nondipping during sleep in healthy humans: effects on baroreflex function at subsequent daytime.,"Blood pressure dipping at night is mediated by sleep-inherent, active downregulation of sympathetic vascular tone. Concomitantly, activity of the renin-angiotensin system is reduced, which might contribute to the beneficial effect of baroreflex downward resetting on daytime blood pressure homeostasis. To evaluate whether experimental nondipping mediated by angiotensin II during sleep would alter blood pressure and baroreflex function the next day in healthy humans, angiotensin-II or placebo (saline) was infused for a 7-h period at night, preventing blood pressure dipping in 11 sleeping normotensive individuals (5 males, balanced, crossover design). Baroreflex function was assessed about 1 h upon awakening and stop of infusion via microneurographic recordings of muscle sympathetic nerve activity (MSNA), showing that resting MSNA was significantly increased following angiotensin II nondipping compared with placebo ( P  = 0.029), whereas blood pressure and heart rate remained unchanged. Baroreflex sensitivity in response to vasoactive drug challenge was preserved, and neuroendocrine markers of fluid balance and electrolytes did not differ between conditions. Ambulatory blood pressure during subsequent daytime was not altered. Data were compared with analog experiments previously performed within the same subjects during awake daytime (ANCOVA). We conclude that angiotensin-II mediated nocturnal nondipping did not induce blood pressure elevation at subsequent daytime in healthy humans but was linked to increased vasoconstrictive sympathetic activity. This is in contrast to a prolonged increase in blood pressure in corresponding daytime experiments of the same individuals. Evidently, sleep strongly preserves normotensive blood pressure homeostasis in healthy humans.",2020,Ambulatory blood pressure during subsequent daytime was not altered.,"['healthy humans', 'eleven sleeping normotensive individuals (5 males, balanced, cross-over design']","['placebo', 'Angiotensin-II or placebo (saline', 'Angiotensin-II-mediated non-dipping', 'Angiotensin-II during sleep']","['Baroreflex sensitivity', 'Ambulatory blood pressure', 'blood pressure elevation', 'Blood pressure', 'baroreflex function', 'blood pressure and heart rate', 'blood pressure', 'blood pressure and baroreflex function', 'normotensive blood pressure homeostasis', 'Baroreflex function', 'vasoconstrictive sympathetic activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0378785', 'cui_str': 'DIPS'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}]","[{'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",11.0,0.0295353,Ambulatory blood pressure during subsequent daytime was not altered.,"[{'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Sayk', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Twesten', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Adametz', 'Affiliation': 'Institute of Radiology, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Franzen', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Dodt', 'Affiliation': 'Department of Emergency Medicine, München-Bogenhausen Hospital, München, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Meusel', 'Affiliation': 'Department of Cardiology and Angiology, University Heart Center Lübeck, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00355.2019']
1171,31535360,An Overnight Stay Versus three Days Admission after Uncomplicated Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE


To evaluate the safety and efficacy of discharging patients on the first postoperative day after an uncomplicated percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS


after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day, we randomly assigned patients into two groups-Group 1: overnight surgery, and Group 2: routine discharge after three days. Patients with significant residual stone on control fluoroscopy were excluded. Ninety eight and 102 patients were assigned to groups 1 and 2, respectively. Serum Hemoglobin and Cr were evaluated before the operation as well as the first postoperative day. Stone free status was evaluated using ultrasound and KUB radiography at the first postoperative day.
RESULTS


The stone and patient characteristics were not different in two groups. The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups. Nine patients (9.2%) in Group 1 and five (4.9%) in Group 2 were readmitted because of complications (mainly hematuria) (p=.23). Of the readmitted patients, five in Group 1 (55%), and three in Group 2 (60%) received blood transfusion (p=.87). in these patients, group 1 received 1.6±0.51 units of blood compared with 1.93±0.25 in group 2 (p=.07). All the readmitted patients did well with conservative therapy with no need for angioembolization.
CONCLUSION


In uncomplicated PCNL with no significant residual stone, discharging the patient on the first postoperative day is safe. The outcome is comparable to a routine three-day hospital stay.",2020,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"['after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day', 'Patients with significant residual stone on control fluoroscopy were excluded', 'Ninety eight and 102 patients']","['overnight surgery, and Group 2: routine discharge', 'Overnight Stay Versus three Days Admission after uncomplicated Percutaneous Nephrolithotomy', 'uncomplicated percutaneous nephrolithotomy (PCNL']","['Serum Hemoglobin and Cr', 'blood transfusion', 'hemoglobin and creatinine levels', 'safety and efficacy']","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0356594,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Basiri@unrc.ir.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Department of Surgery, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. drdavoodarab@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Department of urology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran. h_pakmanesh@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Abedinzadeh', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. abedinoro@yahoo.com.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. hormozkarami@yahoo.com.'}]",Urology journal,['10.22037/uj.v0i0.5314']
1172,31586194,Developing a Psychological-Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned From the Field.,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
PURPOSE


Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results-and resulting decision-making process-related to experiments at each step to display the practical challenges present at each stage.
METHODS


To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery.
RESULTS


Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process.
CONCLUSIONS


A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.",2020,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
",[],"['positive psychology (PP) based intervention', 'combined PP-motivational interviewing intervention', 'Multiphase Optimization Strategy']",[],[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],255.0,0.0166421,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center and Department of Human Development and Family Studies, Pennsylvania State University, University Park, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz035']
1173,31526916,Impact of a low-cost standing desk on reducing workplace sitting (StandUP UBC): A randomised controlled trial.,"Sit-stand desks can reduce occupational sitting time, however, their cost can limit scalability. The purpose of this study was to evaluate the impact of a low-cost standing desk on objectively-measured occupational sitting and prolonged sitting bouts over 3- and 6-months. Secondary outcomes included self-report work engagement and occupational fatigue. Forty-eight office employees (91.7% female, M age  = 39.8 ± 10.1) were randomized to receive a low-cost standing desk or to a control group. At 3-months, the intervention group sat 0.7 h (42min) less at work compared to the control group; F(1, 45) = 5.90, partial η 2  = 0.12, p = .019. The effect was small, yet comparable to findings from studies using costlier alternatives. However, these reductions were not maintained at 6-months. No changes in prolonged sitting bouts or secondary outcomes were found. There is some potential for low-cost standing desk converters as a scalable workplace health intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03375749, Registered 18 December 2017, https://clinicaltrials.gov/ct2/show/NCT03375749?term=NCT03375749&rank=1.",2020,"At 3-months, the intervention group sat 0.7 h (42min) less at work compared to the control group; F(1, 45) = 5.90, partial η 2  = 0.12, p = .019.","['Forty-eight office employees (91.7% female, M age \u202f=\u202f39.8\u202f±\u202f10.1']","['low-cost standing desk or to a control group', 'low-cost standing desk']","['workplace sitting (StandUP UBC', 'prolonged sitting bouts', 'occupational sitting time', 'self-report work engagement and occupational fatigue', 'objectively-measured occupational sitting and prolonged sitting bouts']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4505268', 'cui_str': 'Workplace Engagement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",48.0,0.0636179,"At 3-months, the intervention group sat 0.7 h (42min) less at work compared to the control group; F(1, 45) = 5.90, partial η 2  = 0.12, p = .019.","[{'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Weatherson', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Kelly B', 'Initials': 'KB', 'LastName': 'Wunderlich', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Faulkner', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, V6T 1Z4, Canada. Electronic address: guy.faulkner@ubc.ca.'}]",Applied ergonomics,['10.1016/j.apergo.2019.102951']
1174,31530665,Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.,"OBJECTIVE


Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy.
RESEARCH DESIGN AND METHODS


LixiLan-G, a randomized, open-label, 26-week trial, compared switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA 1c  7-9% (53-75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors. Adherence to randomized treatment was closely monitored throughout the study.
RESULTS


iGlarLixi ( n  = 257) reduced HbA 1c  more than continued GLP-1 RA therapy ( n  = 257) from a baseline 7.8% (62 mmol/mol) in both to 6.7% (50 mmol/mol) and 7.4% (57 mmol/mol), respectively, at 26 weeks (least squares mean difference -0.6%;  P  < 0.0001). More iGlarLixi patients achieved HbA 1c  <7% (53 mmol/mol) (62% vs. 26%;  P  < 0.0001) and the composite of HbA 1c  <7% without documented symptomatic hypoglycemia (<54 mg/dL). Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy.
CONCLUSIONS


Switching to iGlarLixi improves glucose control for patients with type 2 diabetes insufficiently controlled on a maximum tolerated dose of a GLP-1 RA plus oral antihyperglycemic agents.",2019,"Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy.
","['type 2 diabetes', 'patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy', 'patients with type 2 diabetes', 'patients with type 2 diabetes and HbA 1c  7-9% (53-75 mmol/mol) taking maximum tolerated doses of a']","['GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors', 'iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA', 'iGlarLixi versus continuing prior GLP-1 RA', 'iGlarLixi', 'GLP-1 RA therapy', 'titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi', 'basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA']","['Nausea and vomiting rates', 'symptomatic hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",75.0,0.0675775,"Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy.
","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA lblonde@ochsner.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'University of Pisa School of Medicine, Pisa, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henry', 'Affiliation': 'University of California, San Diego, and Center for Metabolic Research, Veterans Affairs San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'Endocrinology, Diabetes, and Metabolism Institute, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Souhami', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}]",Diabetes care,['10.2337/dc19-1357']
1175,32430987,Negative pressure drainage-assisted irrigation for maxillofacial space infection.,"OBJECTIVE


In this study, the clinical effect of negative pressure drainage-assisted irrigation (NPDI) technique was evaluated in treating maxillofacial space infection (MSI) by comparing with traditional technique.
METHOD


A prospective study was conducted in 58 patients with MSI. The patients were randomly divided into two groups based on different treatment techniques. Thirty patients receiving NPDI were included in NPDI group, and 28 patients receiving traditional technique were included in traditional group. Case data (gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, airway control method) and clinical effect (postoperative hospital stay, total cost of admission) for the two groups were analyzed.
RESULTS


Patients in both groups were cured clinically. There were no significant differences in gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, and airway control method in NPDI group and traditional group (p > .05). The postoperative hospital stay and the total cost of admission in the NPDI group were significantly lower than the traditional group (p < .001).
CONCLUSION


Negative pressure drainage-assisted irrigation used in the treatment of MSI can shorten the postoperative hospital stay, reduce the total cost of admission, and show favorably clinical effect. It is a clinically recommended method for MSI.",2020,"The postoperative hospital stay and the total cost of admission in the NPDI group was significantly lower than the traditional group (P <0.001).
","['30 patients receiving NPDI were included in NPDI group, and 28 patients receiving traditional technique were included in traditional group', '58 patients with MSI']","['negative pressure drainage assisted irrigation (NPDI) technique', 'Negative pressure drainage assisted irrigation']","['clinical effect (postoperative hospital stay, total cost of admission', 'gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, airway control method', 'postoperative hospital stay and the total cost of admission', 'total cost of admission', 'postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",58.0,0.0131721,"The postoperative hospital stay and the total cost of admission in the NPDI group was significantly lower than the traditional group (P <0.001).
","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Stomatology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, China.'}, {'ForeName': 'Yao-Xiang', 'Initials': 'YX', 'LastName': 'Xu', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Fu', 'Affiliation': 'Department of Stomatology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Stomatology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Wen-Lin', 'Initials': 'WL', 'LastName': 'Xiao', 'Affiliation': 'Department of Stomatology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Oral diseases,['10.1111/odi.13421']
1176,17889865,Comparison of concomitant outcome achieved with fresh and cryopreserved donor oocytes vitrified by the Cryotop method.,"OBJECTIVE


To evaluate the outcome of oocyte vitrification using the Cryotop method, observed in an egg donation program by simultaneously evaluating embryos derived from vitrified and fresh oocytes coming from the same stimulated cycle.
DESIGN


Cohort prospective randomized study.
SETTING


Instituto Valenciano de Infertilidad (IVI) Valencia, Spain.
PATIENT(S)


Thirty oocyte donors and 30 recipients with informed consents.
INTERVENTION(S)


Vitrification by the Cryotop method. Warming 1 hour after vitrification. Microinjection of surviving MII and fresh oocytes, evaluation of fertilization, embryo development, and clinical results.
MAIN OUTCOME MEASURE(S)


Survival, fertilization, and cleavage rate. Embryo quality, pregnancy rate (PR), and implantation rate.
RESULT(S)


Survival rate observed was 96.7%. There was no difference in fertilization rates (76.3% and 82.2%), day 2 cleavage (94.2% and 97.8%), day 3 cleavage (80.8% and 80.5%), and blastocyst formation (48.7% and 47.5%) for vitrified and fresh oocytes, respectively. Embryo quality on day 3 and on day 5-6 were similar for vitrification and fresh oocyte group (80.8% vs. 80.5% and 81.1% vs. 70%, respectively). A total of 23 embryo transfers were carried out in the vitrification group. Pregnancy rates, implantation rates, miscarriage rates, and ongoing PR were 65.2%, 40.8%, 20%, and 47.8%, respectively.
CONCLUSION(S)


The Cryotop method preserves the potential of vitrified oocytes to fertilize and further develop, which is similar, when evaluated simultaneously, to fresh counterparts. Excellent clinical outcome indicates the possible use of this technology for egg donation programs, as well as a high potential for establishing oocyte banking.",2008,"Embryo quality on day 3 and on day 5-6 were similar for vitrification and fresh oocyte group (80.8% vs. 80.5% and 81.1% vs. 70%, respectively).","['23 embryo transfers', 'Instituto Valenciano de Infertilidad (IVI) Valencia, Spain', 'Thirty oocyte donors and 30 recipients with informed consents']",[],"['blastocyst formation', 'Microinjection of surviving MII and fresh oocytes, evaluation of fertilization, embryo development, and clinical results', 'Embryo quality', 'Pregnancy rates, implantation rates, miscarriage rates, and ongoing PR', 'Survival rate', 'Embryo quality, pregnancy rate (PR), and implantation rate', 'Survival, fertilization, and cleavage rate', 'fertilization rates']","[{'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3267027', 'cui_str': 'Oocyte donor'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]",[],"[{'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0025991', 'cui_str': 'Microinjections'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013936', 'cui_str': 'Embryonic Development'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0635158,"Embryo quality on day 3 and on day 5-6 were similar for vitrification and fresh oocyte group (80.8% vs. 80.5% and 81.1% vs. 70%, respectively).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cobo', 'Affiliation': 'IVI Universidad de Valencia, Valencia, Spain. acobo@ivi.es'}, {'ForeName': 'Masashigue', 'Initials': 'M', 'LastName': 'Kuwayama', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pérez', 'Affiliation': ''}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Ruiz', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Remohí', 'Affiliation': ''}]",Fertility and sterility,[]
1177,19552597,"Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: a pilot randomized, sham-controlled clinical trial.","OBJECTIVES


The objective of this study was to investigate the effect of acupuncture administered during myelosuppressive chemotherapy on white blood cell (WBC) count and absolute neutrophil count (ANC) in patients with ovarian cancer.
DESIGN


This study is a pilot, randomized, sham-controlled clinical trial. Patients received active acupuncture versus sham acupuncture while undergoing chemotherapy. A standardized acupuncture protocol was employed with manual and electrostimulation. The frequency of treatment was 2-3 times per week for a total of 10 sessions, starting 1 week before the second cycle of chemotherapy.
SETTING


The setting was two outpatient academic centers for patients with cancer.
SUBJECTS


Twenty-one (21) newly diagnosed and recurrent ovarian cancer patients were the subjects.
OUTCOME MEASURES


WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF ) were assessed weekly.
RESULTS


The median leukocyte value in the acupuncture arm at the first day of the third cycle of chemotherapy was significantly higher than in the control arm after adjusting for baseline value (8600 cells/microL, range: 4800-12,000 versus 4400 cell/microL, range: 2300-10,000) (p = 0.046). The incidence of grade 2-4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02). However, the median leukocyte nadir, neutrophil nadir, and recovering ANC were all higher but not statistically significantly different (p = 0.116-0.16), after adjusting for baseline differences. There were no statistically significant differences in plasma G-CSF between the two groups.
CONCLUSIONS


We observed clinically relevant trends of higher WBC values during one cycle of chemotherapy in patients with ovarian cancer, which suggests a potential myeloprotective effect of acupuncture. A larger trial is warranted to more definitively determine the efficacy of acupuncture on clinically important outcomes of chemotherapy-induced neutropenia.",2009,The incidence of grade 2-4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02).,"['newly diagnosed and recurrent ovarian cancer patients were the subjects', 'Twenty-one (21', 'patients with gynecologic malignancies', 'patients with ovarian cancer', 'patients with cancer']","['acupuncture', 'active acupuncture versus sham acupuncture while undergoing chemotherapy', 'myelosuppressive chemotherapy', 'Acupuncture']","['plasma G-CSF', 'incidence of grade 2-4 leukopenia', 'median leukocyte value', 'white blood cell (WBC) count and absolute neutrophil count (ANC', 'neutropenia', 'median leukocyte nadir, neutrophil nadir, and recovering ANC', 'WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF ']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]",,0.240539,The incidence of grade 2-4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02).,"[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. Weidong_lu@dfci.harvard.edu'}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Doherty-Gilman', 'Affiliation': ''}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dean-Clower', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rosulek', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gibson', 'Affiliation': ''}, {'ForeName': 'Annekathryn', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ''}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rosenthal', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': ''}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2008.0589']
1178,32428430,Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.,"Background.  Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA.  Methods.  We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study.  Results.  From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  Conclusions.  In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.",2020,Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  ,"['A total of 69 interviews were conducted with 48 clinicians at 3 time points', 'From June 2015 to January 2017, 248 patients and their caregivers were enrolled']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],69.0,0.0341025,Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  ,"[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Veterans Affairs Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO, USA.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Morris', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Venechuk', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'LaRue', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blue', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Mary Norine', 'Initials': 'MN', 'LastName': 'Walsh', 'Affiliation': 'St. Vincent Heart Center, Division of Cardiology, Indianapolis, IN, USA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20915227']
1179,18164819,Baroreflex sensitivity associated hypoalgesia in healthy states is altered by chronic pain.,"While experimental baroreceptor stimulation is known to elicit hypoalgesia in healthy individuals, the impact of spontaneous baroreflex sensitivity (BRS) on acute pain responses is not known. We tested for associations between BRS and pain responses in healthy individuals, whether these associations are altered in chronic low back pain (CLBP), and the role of alpha-2 adrenergic (ADRA2) mechanisms in these effects. Twenty-five healthy controls and 21 CLBP subjects completed three acute pain tasks after receiving placebo or an intravenous ADRA2 antagonist (yohimbine hydrochloride, 0.4 mg/kg) across two sessions in counterbalanced order. Resting pre-drug spontaneous BRS was assessed using the sequence method. CLBP subjects displayed lower resting BRS(Down) than controls (p<.05). Drug x BRS(Down) interactions indicated that significant BRS-related hypoalgesia on thermal pain threshold and tolerance was eliminated with yohimbine (p's<.05). Subject Type x BRS(Up) interactions on finger pressure (MPQ-Sensory) and ischemic tasks (MPQ-Sensory, pain threshold, intra-task numeric intensity ratings) indicated that inverse BRS/pain associations in controls (p's<.05) were absent in CLBP subjects. Subject TypexDrug x BRS(Down) interactions on finger pressure MPQ-Sensory and intra-task numeric intensity ratings (p's<.05) indicated that for controls, yohimbine attenuated the significant inverse BRS/pain sensitivity associations noted under placebo. In contrast, CLBP subjects displayed a nonsignificant positive BRS/pain association under placebo, with yohimbine producing an inverse association similar to controls (significant for MPQ-Sensory). Results suggest presence of spontaneous BRS-related hypoalgesia in healthy individuals that is partially mediated by ADRA2 mechanisms, and that CLBP blunts BRS-related hypoalgesia. As a group, the CLBP subjects do not manifest baroreceptor-induced antinociception.",2008,"Twenty-five healthy controls and 21 CLBP subjects completed three acute pain tasks after receiving placebo or an intravenous ADRA2 antagonist (yohimbine hydrochloride, 0.4 mg/kg) across two sessions in counterbalanced order.","['healthy individuals', 'Twenty-five healthy controls and 21 CLBP subjects']","['CLBP', 'yohimbine', 'placebo', 'intravenous ADRA2 antagonist (yohimbine hydrochloride']","['finger pressure MPQ-Sensory and intra-task numeric intensity ratings', 'acute pain tasks', 'lower resting BRS(Down', 'BRS and pain responses', 'finger pressure (MPQ-Sensory) and ischemic tasks (MPQ-Sensory, pain threshold, intra-task numeric intensity ratings']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0521933', 'cui_str': 'Yohimbine hydrochloride'}]","[{'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",25.0,0.070058,"Twenty-five healthy controls and 21 CLBP subjects completed three acute pain tasks after receiving placebo or an intravenous ADRA2 antagonist (yohimbine hydrochloride, 0.4 mg/kg) across two sessions in counterbalanced order.","[{'ForeName': 'Ok Y', 'Initials': 'OY', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, 701 Medical Arts Building, 1211 Twenty-First, Avenue South, Nashville, TN 37212, USA. ok.yung.chung@vanderbilt.edu'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Diedrich', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robertson', 'Affiliation': ''}]",Pain,['10.1016/j.pain.2007.11.011']
1180,32011369,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001159']
1181,31583947,The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements.,"Background.  Previous research found that adding a single piece of quantitative information about prescription drug benefits to direct-to-consumer (DTC) ads helps consumers understand how well the drug works. However, drug information often includes quantitative information on multiple benefit outcomes and risks. Thus, we examined whether consumer understanding was similarly improved when DTC television ads include varying amounts of quantitative information.  Methods.  We randomly assigned participants (945 Internet panelists ≥ 60 years old) to view 1 of 9 fictitious prescription drug television ads that varied the presentation of quantitative information for benefits (none, single outcome, 2 outcomes) and risks (none, 1 risk category, 3 risk categories) and then measured gist and verbatim recall/estimation and drug perceptions.  Results.  Adding a single benefit outcome and a single risk category replicated past results. Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting 2 benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category.  Limitations.  This study may have limited generalizability because it examined an ad for only 1 medical condition.  Conclusions.  There are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug's risks.",2019,"Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions.",[],[],"['verbatim recall', 'gist and verbatim recall and affected drug perceptions']",[],[],"[{'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",945.0,0.0315478,"Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions.","[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Lynch', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19875946']
1182,31355775,Doravirine dose selection and 96-week safety and efficacy versus efavirenz in antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial.,"BACKGROUND


The safety and efficacy of doravirine were compared with that of efavirenz as initial treatment of adults living with HIV-1 infection (NCT01632345).
METHODS


A Phase IIb double-blind trial with participants stratified by screening HIV-1 RNA (≤ or >100,000 copies/ml) and randomized 1:1:1:1:1 to receive once-daily doravirine (25, 50, 100 or 200 mg) or efavirenz 600 mg (Part I) for up to 96 weeks, with open-label tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC). After dose selection at week 24, doravirine 100 mg was provided to participants receiving the other doses of doravirine and additional participants were randomized 1:1 to receive once-daily doravirine 100 mg or efavirenz 600 mg for 96 weeks with TDF/FTC (Part II). Primary outcomes were the proportion of participants with HIV-1 RNA <40 copies/ml at week 24, and central nervous system (CNS) adverse events (AEs) by weeks 8 and 24 (Parts I+II combined).
RESULTS


210 and 132 participants were randomized in Parts I and II, respectively, and 216 (108 on doravirine 100 mg, 108 on efavirenz) were evaluable for Parts I+II combined. At week 24, the proportion of participants with HIV-1 RNA <40 copies/ml was 72.9% for doravirine 100 mg and 73.1% for efavirenz (difference -0.5 [95% CI -12.3, 11.2]). In addition, CNS AEs were reported by 26.9% and 47.2% of doravirine and efavirenz recipients, respectively (difference -20.4 [95% CI -32.6, -7.5]; P=0.002).
CONCLUSIONS


Doravirine 100 mg with TDF/FTC demonstrated similar antiretroviral activity and superior CNS safety compared with efavirenz 600 mg with TDF/FTC.",2019,"At Week 24, the proportion of participants with HIV-1 RNA <40 copies/ml was 72.9% for doravirine 100 mg and 73.1% for efavirenz (difference -0.5 [95% CI -12.3-11.2]).","['210 and 132 participants', 'adults living with HIV-1 infection (NCT01632345', 'participants stratified by screening HIV-1 RNA (≤ or >100 000 copies/ml', 'antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial']","['efavirenz 600 mg (Part I) for up to 96 weeks, with open-label tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC', 'Doravirine 100 mg with TDF/FTC', 'doravirine 100 mg, 108 on efavirenz', 'doravirine 100 mg or efavirenz 600 mg for 96 weeks with TDF/FTC', 'TDF/FTC', 'efavirenz', 'doravirine']","['antiretroviral activity and superior CNS safety', 'proportion of participants with HIV-1 RNA <40 copies/ml at Week 24, and central nervous system (CNS) adverse events (AEs']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1593581', 'cui_str': 'efavirenz 600 MG [Sustiva]'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1593509', 'cui_str': 'Tenofovir disoproxil fumarate 300 MG [Viread]'}, {'cui': 'C1594209', 'cui_str': 'emtricitabine 200 MG [Emtriva]'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",132.0,0.36735,"At Week 24, the proportion of participants with HIV-1 RNA <40 copies/ml was 72.9% for doravirine 100 mg and 73.1% for efavirenz (difference -0.5 [95% CI -12.3-11.2]).","[{'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Gatell', 'Affiliation': 'Hospital Clinic/IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Javier O', 'Initials': 'JO', 'LastName': 'Morales-Ramirez', 'Affiliation': 'Clinical Research Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Debbie P', 'Initials': 'DP', 'LastName': 'Hagins', 'Affiliation': 'Chatham County Health Department, Savannah, GA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Keikawus', 'Initials': 'K', 'LastName': 'Arastéh', 'Affiliation': 'EPIMED/Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'ICH Study Center, Hamburg, Germany.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Infectious Diseases Department and INSERM CIC 1413, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': 'Triple O Research Institute PA, West Palm Beach, FL, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Dretler', 'Affiliation': 'Infectious Disease Specialists of Atlanta, Decatur, GA, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Plettenberg', 'Affiliation': 'ifi-Institute for Infections, Hamburg, Germany.'}, {'ForeName': 'Don E', 'Initials': 'DE', 'LastName': 'Smith', 'Affiliation': 'Albion Centre, Sydney, Australia.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Portilla', 'Affiliation': 'Hospital General Universitario de Alicante/ISABIAL, Alicante, Spain.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Rugina', 'Affiliation': 'Ovidius University, Clinical Infectious Diseases Hospital, Constanta, Romania.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Frobose', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Teppler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Antiviral therapy,['10.3851/IMP3323']
1183,32430693,"A multi-camera, multi-view system for training and skill assessment for robot-assisted surgery.","PURPOSE


This paper introduces the concept of using an additional intracorporeal camera for the specific goal of training and skill assessment and explores the benefits of such an approach. This additional camera can provide an additional view of the surgical scene, and we hypothesize that this additional view would improve surgical training and skill assessment in robot-assisted surgery.
METHODS


We developed a multi-camera, multi-view system, and we conducted two user studies ([Formula: see text]) to evaluate its effectiveness for training and skill assessment. In the training user study, subjects were divided into two groups: a single-view group and a dual-view group. The skill assessment study was a within-subject study, in which every subject was shown single- and dual view recorded videos of a surgical training task, and the goal was to count the number of errors committed in each video.
RESULTS


The results show the effectiveness of using an additional intracorporeal camera view for training and skill assessment. The benefits of this view are modest for skill assessment as it improves the assessment accuracy by approximately 9%. For training, the additional camera view is clearly more effective. Indeed, the dual-view group is 57% more accurate than the single-view group in a retention test. In addition, the dual-view group is 35% more accurate and 25% faster than the single-view group in a transfer test.
CONCLUSION


A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery. One application of our work is to include an additional camera view in existing virtual reality surgical training simulators to realize its benefits in training. The views from the additional intracorporeal camera can also be used to improve on existing surgical skill assessment criteria used in training systems for robot-assisted surgery.",2020,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.",[],['single-view group and a dual-view group'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",[],,0.0292817,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.","[{'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Abdelaal', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada. aabdelaal@ece.ubc.ca.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Avinash', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Kalia', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Hager', 'Affiliation': 'Department of Computer Science, Johns Hopkins University, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Septimiu E', 'Initials': 'SE', 'LastName': 'Salcudean', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02176-1']
1184,31535384,Effect of C1-inhibitor in adults with mild asthma: A randomized controlled trial.,,2020,,['adults with mild asthma'],['C1-inhibitor'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C1446194', 'cui_str': 'Serum C1 inhibitor antigen measurement'}]",[],,0.248424,,"[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bastiaan W', 'Initials': 'BW', 'LastName': 'Haak', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter I', 'Initials': 'PI', 'LastName': 'Bonta', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christof J', 'Initials': 'CJ', 'LastName': 'Majoor', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': ""van 't Veer"", 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'de Vos', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'E Marleen', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Lutter', 'Affiliation': 'Department of Experimental Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Mierlo', 'Affiliation': 'Sanquin Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Sacha S', 'Initials': 'SS', 'LastName': 'Zeerleder', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': 'Center of Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Allergy,['10.1111/all.14053']
1185,32428426,What Helps People Make Values-Congruent Medical Decisions? Eleven Strategies Tested across 6 Studies.,"Background.  High-quality health decisions are often defined as those that are both evidence informed and values congruent. A values-congruent decision aligns with what matters to those most affected by the decision. Values clarification methods are intended to support values-congruent decisions, but their effects on values congruence are rarely evaluated.  Methods.  We tested 11 strategies, including the 3 most commonly used values clarification methods, across 6 between-subjects online randomized experiments in demographically diverse US populations ( n 1 = 1346,  n 2 = 456,  n 3 = 840,  n 4 = 1178,  n 5 = 841,  n 6 = 2033) in the same hypothetical decision. Our primary outcome was values congruence. Decisional conflict was a secondary outcome in studies 3 to 6.  Results.  Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions. Strategies using mathematical models to show participants which option aligned with what mattered to them encouraged values-congruent decisions and reduced decisional conflict when assessed.  Limitations.  A hypothetical decision was necessary for ethical reasons, as we believed some strategies may harm decision quality. Later studies used more outcomes and covariates. Results may not generalize outside US-based adults with online access. We assumed validity and stability of values during the brief experiments.  Conclusions.  Failing to explicitly support the process of aligning options with values leads to increased proportions of values-incongruent decisions. Methods representing more than half of values clarification methods commonly in use failed to encourage values-congruent decisions. Methods that use models to explicitly show people how options align with their values offer more promise for helping people make decisions aligned with what matters to them. Decisional conflict, while arguably an important outcome in and of itself, is not an appropriate proxy for values congruence.",2020,"Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions.","['demographically diverse US populations ( n 1 = 1346,  n 2 = 456,  n 3 = 840,  n 4 = 1178,  n 5 = 841,  n 6 = 2033) in the same hypothetical decision']",[],"['Decisional conflict', 'decisional conflict']","[{'cui': 'C4708913', 'cui_str': '840'}]",[],"[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",,0.125062,"Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions.","[{'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Universite Laval Faculte de medecine, Quebec, QC, Canada.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Julien', 'Affiliation': 'Universite Laval Faculte des sciences et de genie, Quebec, QC, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ndjaboue', 'Affiliation': 'Universite Laval Faculte de medecine, Quebec, QC, Canada.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Exe', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie C', 'Initials': 'VC', 'LastName': 'Kahn', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Angie Fagerlin', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Zikmund-Fisher', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, MI, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20904955']
1186,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND


Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes.
AIMS OF THE STUDY


To examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS).
METHODS


Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial ends.
RESULTS


Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P < .01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P < .01).
CONCLUSIONS


The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first-treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287']
1187,31553693,"High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.","PURPOSE


The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases.
METHODS


From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and  P  value were corrected for the three previous interim analyses by the inverse normal method.
RESULTS


Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44;  P  = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm.
CONCLUSION


In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.",2019,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16).","['Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases', 'From 2000 to 2015, we enrolled patients older than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases', 'Ewing Sarcoma', 'Selected patients requiring radiotherapy to an axial primary site', 'Of 543 potentially eligible patients']","['standard chemotherapy with WLI', 'busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI', 'Standard Chemotherapy and Lung Radiation', 'radiotherapy and busulfan', 'chemotherapy', 'High-Dose Chemotherapy', 'BuMel', 'vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI', 'VAI plus WLI']","['severe acute toxicities', 'Event-free survival', 'survival outcomes', 'overall survival', 'hazard ratio (HR']","[{'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0153678', 'cui_str': 'Secondary malignant neoplasm of pleura (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",287.0,0.239424,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10;  P  = .16).","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Cozic', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van den Berg', 'Affiliation': 'Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Brichard', 'Affiliation': 'Cliniques Universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Centre Léon Bérard, Lyon; France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Craft', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Amler', 'Affiliation': 'Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guinbretiere', 'Affiliation': 'Hôpital René-Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hauser', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hjorth', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janeway', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Juergens', 'Affiliation': 'Universitaetskinderklinik Muenster, Muenster, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Foundation NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jarmila', 'Initials': 'J', 'LastName': 'Kruseova', 'Affiliation': 'Charles University Prague, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuehne', 'Affiliation': ""University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lewis', 'Affiliation': 'University of Leeds, Liverpool, United Kingdom.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Centre Hospitalier Universitaire, Tours, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Institute of Pediatric Onco-Haematology, Lyon, France.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Five Time Therapeutics, South San Francisco, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Witten/Herdecke University, Datteln, Germany.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'University of California Davis, Sacramento, CA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ranft', 'Affiliation': 'Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Oberlin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00915']
1188,31522985,"Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study.","INTRODUCTION


Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of flibanserin with alcohol.
AIM


To evaluate the impact of the timing of alcohol consumption on flibanserin safety and tolerability.
METHODS


In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1-3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication.
OUTCOMES


The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence).
RESULTS


1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose-timing treatment, there were no statistically significant differences for flibanserin compared with placebo. Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0-5.0% after flibanserin dosing and 1.7-6.6% after placebo dosing.
CLINICAL IMPLICATIONS


Ethanol interaction with flibanserin was not observed in this study.
STRENGTHS & LIMITATIONS


This study provides information regarding the use of flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of flibanserin is not consistent with the drug's indicated bedtime dosing.
CONCLUSION


Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779-1786.",2019,Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing.,"['Healthy Premenopausal Women', 'premenopausal women', '64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years']","['alcohol consumption', 'flibanserin alone or ethanol', 'placebo', 'Flibanserin Administration Relative to Alcohol Intake', 'Flibanserin', 'ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol', 'once-daily flibanserin 100 mg or placebo']","['flibanserin safety and tolerability', 'primary endpoint event (syncope', 'incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence', 'percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention', 'orthostatic hypotension', 'incidence of hypotension, orthostatic hypotension, or syncope', 'Rates of hypotension']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4051422', 'cui_str': 'flibanserin 100 MG [Addyi]'}]","[{'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",64.0,0.448911,Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing.,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University School of Medicine and IntimMedicine Specialists, Washington, DC, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Sheryl A', 'Initials': 'SA', 'LastName': 'Kingsberg', 'Affiliation': ""University Hospitals Cleveland Medical Center, MacDonald Women's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Noel N', 'Initials': 'NN', 'LastName': 'Kim', 'Affiliation': 'Institute for Sexual Medicine, San Diego, CA, USA. Electronic address: nkim@ismlab.org.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.08.006']
1189,31714608,Improving timely access to food allergy care: A pragmatic controlled trial.,,2020,,[],[],[],[],[],[],,0.0896965,,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stival', 'Affiliation': ""Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Peat', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Molloy', 'Affiliation': ""Population Allergy, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Sharoan', 'Initials': 'S', 'LastName': 'Selvakumaran', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Mimi L K', 'Initials': 'MLK', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}]",Allergy,['10.1111/all.14105']
1190,32432795,"The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial.","AIM


To assess the effect of a 4-week mindfulness-based training intervention on improving stress, anxiety, depression and job satisfaction among ward nurses.
BACKGROUND


Previous literature showed that mindfulness-based training is useful for helping nurses cope with stress.
METHOD


Nurses who have mild to moderate levels of stress, anxiety and depression identified from a teaching hospital were invited to a randomized control trial. The intervention group had a 2-hr Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website. Both the intervention group (n = 118) and the control group (n = 106) were evaluated pre- and post-intervention, and 8 weeks later (follow-up) using the Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale and Mindful Attention Awareness Scale.
RESULTS


There was a significant effect over time on stress, anxiety, depression and mindfulness level (p < .05). Regarding the difference between the groups and interaction between time and group, there was a significant effect for anxiety (p = .037 p = .008) and job satisfaction (p < .001, p = .40), respectively, with moderate effect size for anxiety reduction (.465) and small for job satisfaction increment (.221).
CONCLUSION


Mindfulness-Based Training is effective in improving anxiety and job satisfaction among nurses.
CLINICAL IMPLICATIONS FOR NURSING MANAGEMENT


Mindfulness-Based Training can be included as hospital policy to reduce anxiety and increase job satisfaction among nurses.",2020,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","['Nurses who have mild to moderate levels of stress, anxiety, and depression identified from a teaching hospital', 'Among Ward Nurses']","['Mindfulness-Based Training', '4-week Mindfulness-Based Training intervention', '2-hour Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website', 'mindfulness training']","['stress, anxiety, depression and mindful level (p˂.05', 'anxiety', 'anxiety and job satisfaction', 'Stress, Anxiety, Depression, and Job Satisfaction', 'anxiety reduction', 'Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale, and Mindful Attention Awareness Scale', 'job satisfaction', 'stress, anxiety, depression, and job satisfaction']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0175315,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","[{'ForeName': 'Sajed Faisal', 'Initials': 'SF', 'LastName': 'Ghawadra', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khatijah', 'Initials': 'K', 'LastName': 'Lim Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Yuen', 'Initials': 'WY', 'LastName': 'Choo', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Danaee', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Cheng Kar', 'Initials': 'CK', 'LastName': 'Phang', 'Affiliation': 'Behavioral Health Centre, Sunway Medical Centre, Selangor, Malaysia.'}]",Journal of nursing management,['10.1111/jonm.13049']
1191,31843945,Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study.,"OBJECTIVE


Data regarding the effects of sodium-glucose cotransporter 2 inhibitors in the elderly (age ≥65 years) and very elderly (age ≥75 years) are limited.
RESEARCH DESIGN AND METHODS


The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 assessed cardiac and renal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. Efficacy and safety outcomes were studied within age subgroups for treatment effect and age-based treatment interaction.
RESULTS


Of the 17,160 patients, 9,253 were <65 years of age, 6,811 ≥65 to <75 years, and 1,096 ≥75 years. Dapagliflozin reduced the composite of cardiovascular death or hospitalization for heart failure consistently, with a hazard ratio (HR) of 0.88 (95% CI 0.72, 1.07), 0.77 (0.63, 0.94), and 0.94 (0.65, 1.36) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction  P  value 0.5277). Overall, dapagliflozin did not significantly decrease the rates of major adverse cardiovascular events, with HR 0.93 (95% CI 0.81, 1.08), 0.97 (0.83, 1.13), and 0.84 (0.61, 1.15) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction  P  value 0.7352). The relative risk reduction for the secondary prespecified cardiorenal composite outcome ranged from 18% to 28% in the different age-groups with no heterogeneity. Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97 (95% CI 0.58, 1.64), 0.50 (0.29, 0.84), and 0.68 (0.29, 1.57) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction  P  value 0.2107). Safety outcomes, including fractures, volume depletion, cancer, urinary tract infections, and amputations were balanced with dapagliflozin versus placebo, and acute kidney injury was reduced, all regardless of age. Genital infections that were serious or led to discontinuation of the study drug and diabetic ketoacidosis were uncommon, yet more frequent with dapagliflozin versus placebo, without heterogeneity (interaction  P  values 0.1058 and 0.8433, respectively).
CONCLUSIONS


The overall efficacy and safety of dapagliflozin are consistent regardless of age.",2020,"Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97","['elderly (age ≥65 years) and very elderly (age ≥75 years', ' 9,253 were <65 years of age, 6,811 ≥65 to <75 years, and 1,096 ≥75 years', 'Elderly', 'patients with type 2 diabetes', '17,160 patients']","['Dapagliflozin', 'sodium-glucose cotransporter 2 inhibitors', 'dapagliflozin', 'dapagliflozin versus placebo']","['composite of cardiovascular death or hospitalization for heart failure', 'Cardiovascular Events', 'Efficacy and safety outcomes', 'rates of major adverse cardiovascular events', 'Major hypoglycemia', 'Safety outcomes, including fractures, volume depletion, cancer, urinary tract infections, and amputations were balanced with dapagliflozin versus placebo, and acute kidney injury', 'relative risk reduction', 'overall efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0646415,"Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97","[{'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel avivit@hadassah.org.il.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, U.K.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}]",Diabetes care,['10.2337/dc19-1476']
1192,31618132,Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer.,"PURPOSE


Most patients with early-stage breast cancer are treated with adjuvant radiotherapy (RT) after breast-conserving surgery (BCS) to prevent locoregional recurrence (LRR). However, no genomic tools are used currently to select the optimal RT strategy.
METHODS


We profiled the transcriptome of primary tumors on a clinical grade assay from the SweBCG91-RT trial, in which patients with node-negative breast cancer were randomly assigned to either whole-breast RT after BCS or no RT. We derived a new classifier, Adjuvant Radiotherapy Intensification Classifier (ARTIC), comprising 27 genes and patient age, in three publicly available cohorts, then independently validated ARTIC for LRR in 748 patients in SweBCG91-RT. We also compared previously published genomic signatures for ability to predict benefit from RT in SweBCG91-RT.
RESULTS


ARTIC was highly prognostic for LRR in patients treated with RT (hazard ratio [HR], 3.4; 95% CI, 2.0 to 5.9;  P  < .001) and predictive of RT benefit ( P interaction  = .005). Patients with low ARTIC scores had a large benefit from RT (HR, 0.33 [95% CI, 0.21 to 0.52],  P  < .001; 10-year cumulative incidence of LRR, 6%  v  21%), whereas those with high ARTIC scores benefited less from RT (HR, 0.73 [95% CI, 0.44 to 1.2],  P  = .23; 10-year cumulative incidence of LRR, 25%  v  32%). In contrast, none of the eight previously published signatures were predictive of benefit from RT in SweBCG91-RT.
CONCLUSION


ARTIC identified women with a substantial benefit from RT as well as women with a particularly elevated LRR risk in whom whole-breast RT was not sufficiently effective and, thus, in whom intensified treatment strategies such as tumor-bed boost, and possibly regional nodal RT, should be considered. To our knowledge, ARTIC is the first classifier validated as predictive of benefit from RT in a phase III clinical trial with patients randomly assigned to receive or not receive RT.",2019,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","['patients with node-negative breast cancer', 'Early-Stage Breast Cancer', '748 patients in SweBCG91-RT', 'patients with early-stage breast cancer']","['whole-breast RT after BCS or no RT', 'adjuvant radiotherapy (RT) after breast-conserving surgery (BCS', 'Clinicogenomic Radiotherapy Classifier']",['predictive of RT benefit'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],748.0,0.0539045,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fishbane', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Shuang G', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Speers', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00761']
1193,31655161,Transcranial alternating current stimulation (tACS) at 40 Hz enhances face and object perception.,"Neurophysiological evidence suggests that face and object recognition relies on the coordinated activity of neural populations (i.e., neural oscillations) in the gamma-band (>30 Hz) range over the occipito-temporal cortex. To test the causal effect of gamma-band oscillations on face and object perception we applied transcranial Alternating Current Stimulation (tACS) in healthy volunteers (N = 60). In this single-blind, sham-controlled study, we examined whether the administration of offline tACS at gamma-frequency (40 Hz) over the right occipital cortex enhances performance of perception and memory of face and object stimuli. We hypothesized that gamma tACS would enhance the perception of both categories of visual stimuli. Results, in line with our hypothesis, show that 40 Hz tACS enhanced both face and object perception. This effect is process-specific (i.e., it does not affect memory), frequency-specific (i.e., stimulation at 5 Hz did not cause any behavioural change), and site-specific (i.e., stimulation of the sensory-motor cortex did not affect performance). Our findings show that high-frequency tACS modulates human visual perception, and it is in line with neurophysiological studies showing that the perception of visual stimuli (i.e., faces and objects) is mediated by oscillations in the gamma-band range. Furthermore, this study adds insight about the design of effective neuromodulation protocols that might have implications for interventions in clinical settings.",2019,To test the causal effect of gamma-band oscillations on face and object perception we applied transcranial Alternating Current Stimulation (tACS) in healthy volunteers (N = 60).,['healthy volunteers (N\u202f=\u202f60'],"['gamma-band oscillations', 'gamma tACS', 'Transcranial alternating current stimulation (tACS', 'transcranial Alternating Current Stimulation (tACS']","['40\u202fHz tACS enhanced both face and object perception', 'perception and memory of face and object stimuli']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0341041,To test the causal effect of gamma-band oscillations on face and object perception we applied transcranial Alternating Current Stimulation (tACS) in healthy volunteers (N = 60).,"[{'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'School of Psychology, University of East London (UEL), London, UK.'}, {'ForeName': 'Elley', 'Initials': 'E', 'LastName': 'Wakui', 'Affiliation': 'School of Psychology, University of East London (UEL), London, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Thoma', 'Affiliation': 'School of Psychology, University of East London (UEL), London, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Center for Working Environment and Human Factors (IfADo), Dortmund, Germany; Department of Neurology, University Medical Hospital Bergmannsheil, Bochum, Germany.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Rivolta', 'Affiliation': 'School of Psychology, University of East London (UEL), London, UK; Department of Education, Psychology and Communication, University of Bari Aldo Moro, Bari, Italy. Electronic address: davide.rivolta@uniba.it.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.107237']
1194,31884564,24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients.,"OBJECTIVE


The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
METHODS


This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
RESULTS


At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
CONCLUSIONS


Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.",2020,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
","['Glaucoma Patients', 'patients with open-angle glaucoma (OAG', 'adult patients with OAG (N\xa0=\u200975) received']","['topical bimatoprost 0.03% once daily', 'Bimatoprost SR', 'Bimatoprost Sustained-Release Implant (Bimatoprost SR', 'biodegradable bimatoprost sustained-release implant (Bimatoprost SR']","['safety and intraocular pressure (IOP)-lowering effects', 'overall AE incidence', 'adverse events (AEs', 'IOP change', 'favorable efficacy and safety profiles', 'mean IOP reduction']","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.167087,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
","[{'ForeName': 'E Randy', 'Initials': 'ER', 'LastName': 'Craven', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, 110, Baltimore, MD, 21287, USA. erandycraven@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walters', 'Affiliation': 'Keystone Research, Ltd, Austin, TX, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Christie', 'Affiliation': 'Scott & Christie and Associates, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Day', 'Affiliation': 'Coastal Research Associates, Roswell, GA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Sacramento Eye Consultants, Sacramento, CA, USA.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Wangsadipura', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Robinson', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bejanian', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-019-01248-0']
1195,32127261,"Reply to letter to the editor, ""A randomized study of botulinum toxin versus botulinum toxin plus physical therapy for treatment of cervical dystonia.""",,2020,,[],['botulinum toxin versus botulinum toxin plus physical therapy'],[],[],"[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.0230456,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Wagle Shukla', 'Affiliation': 'Department of Neurology, University of Florida College of Medicine, Gainesville, FL, USA. Electronic address: aparna.shukla@neurology.ufl.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.01.014']
1196,32114073,Data for beta-blockade in ACLS - A trial sequential analysis.,,2020,,[],[],[],[],[],[],,0.123388,,"[{'ForeName': 'Mayuri', 'Initials': 'M', 'LastName': 'Manogaran', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Canada. Electronic address: mayuri.manogaran@mail.mcgill.ca.'}, {'ForeName': 'Stephen Su', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Canada; Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada.'}]",Resuscitation,['10.1016/j.resuscitation.2020.02.019']
1197,30698487,"A Randomized, Double-Blinded, Placebo-Controlled, Dose-Escalation Phase 1 Study of Aerosolized Pirfenidone Delivered via the PARI Investigational eFlow Nebulizer in Volunteers and Patients with Idiopathic Pulmonary Fibrosis.","Background:  This clinical trial evaluated the pharmacokinetics and safety/tolerability of inhaled pirfenidone solution in volunteers and patients with idiopathic pulmonary fibrosis (IPF).  Methods:  Forty-four adults in six cohorts consented to receive single doses of a 12.5 mg/mL pirfenidone solution or placebo to assess tolerability and pharmacokinetics. Cohorts 1, 2, and 3 (normal healthy volunteers [NHV]) ( n  = 6 active;  n  = 2 placebo in each cohort) received 25, 50, and 100 mg pirfenidone, respectively. Cohort 4 (NHV) ( n  = 6 all active) received 100 mg of pirfenidone and underwent bronchoalveolar lavage (BAL) to measure epithelial lining fluid (ELF) pirfenidone concentrations. Cohort 5 (prior or current smokers with greater than 20 pack-year use) ( n  = 6 active;  n  = 2 placebo) and Cohort 6 (IPF patients) ( n  = 6 all active) received 100 mg of pirfenidone. All treatments were administered with an Investigational eFlow ®  Nebulizer System (PARI Pharma GmbH). Serial measures of urine and plasma pirfenidone were collected during the 24-hour postdose in all subjects.  Results:  Administration time ranged from 1.4 to 2 min/mL. No clinically relevant adverse effects on respiratory rate, spirometry, or oxygenation were observed. Drug-related adverse events were predominantly cough,  n  = 8/44 (one in IPF cohort), all mild, transient, and not dose limiting. Mean plasma pirfenidone Cmax levels in the 25, 50, 100 mg NHV, 100 mg smoker, and IPF cohorts were 202, 292, 802, 1370, 1016, and 1026 ng/mL, respectively. BAL cohort estimated ELF Cmax was 135.9 ± 54.5 μg/mL. In the BAL and IPF cohorts, 24-hour urine excretion of pirfenidone and metabolites data suggests similar alveolar deposition.  Conclusions:  Aerosol pirfenidone was well tolerated in normal volunteers, smokers, and IPF patients. High ELF concentrations were achieved in NHV with a 100 mg nebulizer dose. The 100 mg nebulizer dose averaged a 15-fold lower systemic pirfenidone exposure than reported with oral administration of the licensed oral dose.",2020,"No clinically relevant adverse effects on respiratory rate, spirometry, or oxygenation were observed.","['Forty-four adults in six cohorts consented to receive', 'Cohorts 1, 2, and 3 (normal healthy volunteers [NHV]) (n\u2009', 'Volunteers and Patients with Idiopathic Pulmonary Fibrosis', 'Cohort 5 (prior or current smokers with greater than 20 pack-year use) (n\u2009', 'volunteers and patients with idiopathic pulmonary fibrosis (IPF', 'normal volunteers, smokers, and IPF patients']","['placebo', 'pirfenidone solution', 'Placebo', '6 active; n\u2009=\u20092 placebo) and Cohort 6 (IPF patients) (n\u2009=\u20096 all active) received 100\u2009mg of pirfenidone', '100\u2009mg of pirfenidone and underwent bronchoalveolar lavage (BAL) to measure epithelial lining fluid (ELF) pirfenidone concentrations', 'single doses of a 12.5\u2009mg/mL pirfenidone solution or placebo', 'Aerosolized Pirfenidone Delivered via the PARI Investigational eFlow Nebulizer', 'Aerosol pirfenidone']","['respiratory rate, spirometry, or oxygenation', 'High ELF concentrations', 'Mean plasma pirfenidone Cmax levels', 'pharmacokinetics and safety/tolerability', 'urine and plasma pirfenidone', 'tolerability and pharmacokinetics']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C3241966'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3661466', 'cui_str': 'Normal Volunteers'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}]","[{'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042037'}]",44.0,0.411206,"No clinically relevant adverse effects on respiratory rate, spirometry, or oxygenation were observed.","[{'ForeName': 'Jun Keng', 'Initials': 'JK', 'LastName': 'Khoo', 'Affiliation': 'Alfred Hospital, Monash University, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'A Bruce', 'Initials': 'AB', 'LastName': 'Montgomery', 'Affiliation': 'Avalyn Pharma, Inc., Seattle, Washington.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Otto', 'Affiliation': 'Avalyn Pharma, Inc., Seattle, Washington.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Surber', 'Affiliation': 'Avalyn Pharma, Inc., Seattle, Washington.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Faggian', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Glaspole', 'Affiliation': 'Alfred Hospital, Monash University, Department of Medicine, Melbourne, Australia.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2018.1507']
1198,32118601,CORR Insights®: No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,,2020,,['TKA'],['CORR Insights®'],[],[],[],[],,0.18893,,"[{'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'P. J. C. Heesterbeek PhD, Senior Researcher, Sint Maartenskliniek, Department of Research, Nijmegen, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001202']
1199,32130172,Effect of a Mobile Phone-Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial.,"BACKGROUND


Recent evidence of the effectiveness of mobile phone-based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics.
OBJECTIVE


This study aimed to evaluate the clinical efficacy and applicability of a mobile phone-based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings.
METHODS


In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians' consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients' SMBG results through an administrator's website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A 1c  (HbA 1c ), and responded to questionnaires about treatment satisfaction and compliance.
RESULTS


At 3 months, participants in the intervention group showed significantly more improvement in HbA 1c  (adjusted mean difference to control -0.30%, 95% CI -0.50 to -0.11; P=.003) and fasting plasma glucose (-17.29 mg/dL, 95% CI -29.33 to -5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA 1c  levels.
CONCLUSIONS


The mobile phone-based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz.",2020,The mobile phone-based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings.,"['tertiary hospitals or professional diabetes clinics', '13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited', 'Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM', 'type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings']","['Mobile Phone-Based Glucose-Monitoring and Feedback System', 'mobile phone-based diabetes management systems', 'mobile phone-based glucose-monitoring and feedback system']","['anthropometry and blood tests, including hemoglobin', 'improvement in HbA 1c', 'glycemic control', 'fasting plasma glucose', 'blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",13.0,0.0716796,The mobile phone-based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings.,"[{'ForeName': 'Yeoree', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Lee', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hun-Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jae-Hyoung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",JMIR mHealth and uHealth,['10.2196/16266']
1200,32035806,"Letter to the Editor, ""A randomized study of botulinum toxin versus botulinum toxin plus physical therapy for treatment of cervical dystonia"".",,2020,,['cervical dystonia'],['botulinum toxin versus botulinum toxin plus physical therapy'],[],"[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],,0.0246716,,"[{'ForeName': 'Melani J', 'Initials': 'MJ', 'LastName': 'Boyce', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia; Physiotherapy Department, Westmead Hospital, Sydney, Australia. Electronic address: melani.boyce@health.nsw.gov.au.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Kennedy', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Alana B', 'Initials': 'AB', 'LastName': 'McCambridge', 'Affiliation': 'Graduate School of Health, Discipline of Physiotherapy, University of Technology Sydney, Sydney, Australia.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.01.015']
1201,32072592,A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders.,"There is an increasing demand for utilization of external data, such as historical study data and patient registry data, to augment the control group in a randomized controlled trial. While such a study design could reduce the time and cost, how to maintain the study validity and integrity is one major statistical challenge that needs to be carefully addressed. We discuss a study design quality process to enhance the study validity and integrity when using this approach. The discussed quality process is tailored to the confirmatory study using a 2-stage design with an emphasis on the interaction process among stakeholders. In an example, the quality process covers a 2-step assessment of the similarity in patient characteristics between the current study and the external data source, and between the treatment and augmented control groups.",2020,"In an example, the quality process covers a 2-step assessment of the similarity in patient characteristics between the current study and the external data source, and between the treatment and augmented control groups.",[],[],[],[],[],[],,0.0413107,"In an example, the quality process covers a 2-step assessment of the similarity in patient characteristics between the current study and the external data source, and between the treatment and augmented control groups.","[{'ForeName': 'Yunling', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Division of Biostatistics, OSB/CDRH, Food and Drug Administration, 10903 New Hampshire Avenue, WO66, Silver Spring, MD, 20993, USA. Yun-ling.xu@fda.hhs.gov.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Division of Biostatistics, OSB/CDRH, Food and Drug Administration, 10903 New Hampshire Avenue, WO66, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Yue', 'Affiliation': 'Division of Biostatistics, OSB/CDRH, Food and Drug Administration, 10903 New Hampshire Avenue, WO66, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': 'Division of Biostatistics, OSB/CDRH, Food and Drug Administration, 10903 New Hampshire Avenue, WO66, Silver Spring, MD, 20993, USA.'}]",Therapeutic innovation & regulatory science,['10.1007/s43441-019-00053-x']
1202,32428528,"Phase 2 randomized, double-blind study of IL-17 targeting with secukinumab in atopic dermatitis.",,2020,"In a clinical trial of moderate-to-severe atopic dermatitis/AD patients treated with anti IL-17mAb/secukinumab, no significant clinical or molecular improvements were seen, even among disease subtypes with high Th-17-skewing (intrinsic/Asian AD).",['Atopic Dermatitis'],"['anti IL-17mAb/secukinumab', 'IL-17-Targeting with Secukinumab']",[],"[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}]",[],,0.307103,"In a clinical trial of moderate-to-severe atopic dermatitis/AD patients treated with anti IL-17mAb/secukinumab, no significant clinical or molecular improvements were seen, even among disease subtypes with high Th-17-skewing (intrinsic/Asian AD).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ungar', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kimmel', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nia', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hashim', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Chima', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Vekaria', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Yeriel', 'Initials': 'Y', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Singer', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Baum', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Mansouri', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taliercio', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Laboratory for Investigative Dermatology, The Rockefeller University, New York, New York. Electronic address: Emma.Guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.04.055']
1203,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
1204,31285591,Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial).,"BACKGROUND


Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET).
METHODS


The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS).
RESULTS


Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively.
CONCLUSION


Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).",2019,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"['Between May 2013 and April 2016, 122 patients were enrolled', 'patients with colorectal liver metastasis (CRLM']","['mFOLFOX6 plus either BEV or CET', 'CET', 'mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab', 'chemotherapy with bevacizumab (BEV) versus cetuximab (CET']","['progression-free survival (PFS', 'resection rates', 'response rates', 'response rate', 'resection rate and survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",122.0,0.166579,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hatano', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Surgery, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Surgery, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Katayose', 'Affiliation': 'Department of Hepatobiliary and Pancreatic, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Divison of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}]",British journal of cancer,['10.1038/s41416-019-0518-2']
1205,17043094,Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer.,"INTRODUCTION


Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined.
METHODS


Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows-Arm A (three-weekly): gemcitabine 1000 mg/m2 infused>30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused>3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused>30 min and paclitaxel 100 mg/m2 infused>1 h, both administered on days 1 and 8 of a 21-day cycle.
RESULTS


One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P=0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P=0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia.
CONCLUSION


In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.",2007,"The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively.","['Previously untreated patients with advanced NSCLC', 'previously untreated advanced non-small-cell lung cancer', 'advanced non-small-cell lung cancer (NSCLC']","['gemcitabine', 'paclitaxel', 'Taxol', 'gemcitabine-paclitaxel', 'gemcitabine 1000 mg/m2 infused>30 min and paclitaxel', 'Gemcitabine and paclitaxel']","['febrile neutropenia', 'Progression-free survival', 'survival and lower hematologic toxicity', 'partial response rates', 'thrombocytopenia', 'neutropenia', '1- and 2-year survival rates', 'Median survival', 'therapeutic index', 'anemia', 'frequency of grade 3/4 hematologic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0678133', 'cui_str': 'Taxol'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0920645,"The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively.","[{'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, PA. Electronic address: belanicp@upmc.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, P.A., Wichita, KS.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Waterhouse', 'Affiliation': 'The Jewish Hospital-Kenwood, Cincinnati, OH.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Desch', 'Affiliation': 'Hematology and Oncology of Virginia, Richmond, VA.'}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Rooney', 'Affiliation': 'Hematology/Oncology, Inc., Canton, OH.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Clark', 'Affiliation': 'Hematology/Oncology Associates, Jackson, MI.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Monberg', 'Affiliation': 'Lilly Research Laboratories, Indianapolis, IN, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Lilly Research Laboratories, Indianapolis, IN, USA.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Obasaju', 'Affiliation': 'Lilly Research Laboratories, Indianapolis, IN, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdl344']
1206,32124549,Do children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation? A report from the Children's Oncology Group.,"BACKGROUND


The role of adjuvant radiotherapy (RT) remains unclear in patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS).
PROCEDURE


Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed. All patients received systemic chemotherapy and 36 Gy adjuvant RT (if given) to the primary site at week 12 or week 4 for D9602/D9803 and ARST0531, respectively.
RESULTS


Thirty-six patients with group I ARMS were treated on D9602 (n = 6), D9803 (n = 17), or ARST0531 (n = 13), of whom 24 (67%) were male. The median age was 4.1 years (range, 0.8-45.8). Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors > 5 cm. FOXO1-fusion status was negative, positive, and unknown in 10 (28%), 15 (42%), and 11 (30%) tumors, respectively. Twenty-two (61%) patients received RT. Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively. Patients with FOXO1 positivity who received RT had superior EFS compared with those who did not (77.8% vs 16.7%; P = 0.03). Among 10 patients who were FOXO1 negative, the outcome was similar with or without RT.
CONCLUSIONS


Although limited by a small sample size, data from this study support the routine use of adjuvant RT in patients with FOXO1-positive disease even after complete resection. Additionally, omitting adjuvant RT is rational for patients with FOXO1-negative ARMS and will be prospectively investigated in the current COG trial ARST1431.",2020,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[""Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed"", 'children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation', 'patients with FOXO1-positive disease even after complete resection', 'The median age was 4.1 years (range, 0.8-45.8', 'patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS', 'Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors\xa0>\xa05\xa0cm', 'Thirty-six patients with group', '10 patients who were FOXO1 negative, the outcome was similar with or without\xa0RT']","['adjuvant radiotherapy (RT', 'systemic chemotherapy and 36\xa0Gy adjuvant RT', 'RT']","['free survival (EFS) and overall survival (OS', 'superior EFS', 'FOXO1-fusion status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",36.0,0.138132,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Aye', 'Affiliation': ""Department of Pediatrics, Children's of Alabama, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Rudzinski', 'Affiliation': ""Department of Pathology, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Odion T', 'Initials': 'OT', 'LastName': 'Binitie', 'Affiliation': ""Department of Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Pediatric General and Thoracic Surgery, Cincinnati Children's Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.28243']
1207,31387410,Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies.,"Objective:  To evaluate the safety and efficacy of fulranumab as adjunct or monotherapy in patients with knee or hip pain related to moderate-to-severe osteoarthritis. Methods:  Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. Safety assessments included treatment-emergent adverse events (TEAEs), and neurological, sympathetic, and joint-related events of interest. Efficacy assessments included pain and physical function sub-scales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Results:  Of 245 patients from the ITT set (median age = 64 years; 62% women), 84 (34%) completed the DB phase; the majority of discontinuations (57%) were due to early study termination. In the DB phase, the incidence of TEAEs in fulranumab 3 mg (57.8%) and 1 mg (56.8%) was similar to placebo (56.8%). Two events adjudicated as joint-related events of interest include rapidly progressive osteoarthritis and fracture of unknown etiology. There were no new neurological TEAEs. Fulranumab showed evidence of efficacy in improving pain and physical function based on WOMAC sub-scale scores. Due to premature study termination, the number of patients enrolled were too small to make any definitive efficacy claims. Conclusions:  Treatment with fulranumab was generally tolerated with no new safety signals. Within the limited sample analyzed, fulranumab showed evidence of improvement of pain and function in patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery. Clinical trial registration numbers:  NCT02336685; NCT02336698; NCT02289716; NCT02301234KEY POINTSFulranumab as adjuvant or monotherapy was well tolerated with no new safety signalsFulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and kneeFulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.",2019,Fulranumab as adjuvant or monotherapy was well tolerated with no new safety signals Fulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and knee Fulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.,"['245 patients from the ITT set (median age, 64 years; women, 62%), 84 (34%) completed DB phase', 'patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery', 'osteoarthritis of the hip and knee', 'Osteoarthritic patients (aged ≥18 years', 'patients with knee or hip pain related to moderate-to-severe osteoarthritis']","['Fulranumab as adjuvant or monotherapy', 'placebo', 'Fulranumab', 'monotherapy', 'placebo, fulranumab', 'fulranumab']","['pain and physical function based on WOMAC subscales scores', 'pain and physical function', 'Safety and efficacy', 'pain and function', 'pain and physical function subscales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores', 'treatment-emergent adverse events (TEAEs), and neurological, sympathetic and joint-related events of interest', 'safety and efficacy']","[{'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2981231', 'cui_str': 'fulranumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",245.0,0.0675394,Fulranumab as adjuvant or monotherapy was well tolerated with no new safety signals Fulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and knee Fulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Sanga', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Zaki', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Haeussler', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Louie', 'Affiliation': 'Janssen Research and Development, LLC, Fremont, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thipphawong', 'Affiliation': 'Janssen Research and Development, LLC, Fremont, CA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1653068']
1208,32434709,Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.,"BACKGROUND


Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment.
AIM


To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods.
METHODS


The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics.
MAIN OUTCOME MEASURES


The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method.
RESULTS


The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60).
CLINICAL IMPLICATIONS


Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates.
STRENGTH & LIMITATIONS


Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size.
CONCLUSION


The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311.",2020,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).",['212 women suffering from provoked vestibulodynia'],"['conventional methods (eg, posters, leaflets, business cards, newspaper ads', 'topical lidocaine']","['cost-effectiveness (cost per enrolled participant), and retention rate', 'Recruitment efficiency', 'health professional referrals', 'Efficiency and Cost', 'retention rate', 'efficiency, effectiveness, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",212.0,0.330363,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Benoit-Piau', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, and Research Center, Institut universitaire de gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Soleil', 'Initials': 'MS', 'LastName': 'Carroll', 'Affiliation': ""Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, and Research Center, Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': 'Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.005']
1209,31519466,Effects of an Evidence-Informed Healthy Eating Blog on Dietary Intakes and Food-Related Behaviors of Mothers of Preschool- and School-Aged Children: A Randomized Controlled Trial.,"BACKGROUND


Although social media such as blogs are still considered innovative communication technologies, some registered dietitians (RDs) are using them to promote healthy eating; however, evidence regarding the effects of healthy eating blogs on users' diet is lacking.
OBJECTIVE


This study evaluated the effects of an evidence-informed healthy eating blog written by an RD on dietary intakes, with a focus on vegetables and fruit and milk and alternatives consumption, and food-related behaviors of Canadian mothers.
DESIGN


This study was a parallel, randomized, controlled trial.
PARTICIPANTS/SETTING


Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth.
INTERVENTION


The intervention was exclusively delivered through an evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption in mothers-for 6 months at a dose of one new post written by an RD each week. Mothers could engage with the RD and fellow participants by posting comments on the blog.
MAIN OUTCOME MEASURES


Main outcomes were daily intakes of vegetables and fruit and milk and alternatives. Outcome assessments were performed at baseline, 3 months, and at the end of the 6-month intervention.
STATISTICAL ANALYSIS


Differences between the groups were examined using mixed linear models.
RESULTS


At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180).
CONCLUSIONS


A healthy eating blog, at a dose of 1 post per week, had no effects on dietary intakes, food-related behaviors, and body weight of mothers after 6 months. Methodologic issues are discussed to inform future health behavior research using blogs to promote healthy eating.",2020,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180).
","['Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth', 'Mothers of Preschool- and School-Aged Children', 'Canadian mothers']","['evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption', 'Evidence-Informed Healthy Eating Blog']","['daily intakes of vegetables and fruit and milk and alternatives', 'dietary intakes, food-related behaviors, and body weight of mothers', 'intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.063081,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180).
","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.016']
1210,31518424,Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults.,"BACKGROUND


There are few studies directly comparing the pharmacokinetics of 25-hydroxycholecalciferol [25(OH)D3] to cholecalciferol (D3).
OBJECTIVES


The primary objectives were to compare the effectiveness of D3 and 25(OH)D3 in raising 25-hydroxyvitamin D [25(OH)D] serum concentrations and achieving steady state.
METHODS


This was a randomized, double-blind, active comparator trial of 91 participants (53 females, 38 males), aged 63.3 ± 7.9 y. 25(OH)D3 (10, 15, and 20 µg) and D3 (20 µg) were dosed daily for 6 mo followed by 6 mo of washout. Frequent measurements of serum 25(OH)D were performed. Pharmacokinetic parameters were fitted for each individual and the treatment average was modeled with linear regression using the individual baseline level, sex, and gender as covariates.
RESULTS


Mean baseline 25(OH)D was similar in all groups (47.1-49.5 nmol/L). Increases in 25(OH)D to steady state were higher in the 25(OH)D3 groups than in the D3 group [least squares (LS) means (95% CI): 50.1 (43.3-58.0), 72.5 (64.3-81.7), 97.4 (86.6-109.6) nmol/L in 10, 15, and 20 µg/d and 38.7 (33.1-45.2) nmol/L in the D3 group; P = 0.0173, P < 0.0001, P < 0.0001]. The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d). The rate of elimination was 59-109% higher in the 25(OH)D3 groups than in the D3 group. The area under the curve (AUC)/µg dose demonstrated that 25(OH)D3 was 3 times as effective as D3 at raising 25(OH)D concentrations.
CONCLUSIONS


25(OH)D3 is ∼3 times as effective as D3 at raising 25(OH)D concentrations. Once supplementation is discontinued, the elimination rate of 25(OH)D3 is faster than D3. This trial was registered at clinicaltrials.gov as NCT02333682.",2020,"The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d).","['Older Adults', '91 participants (53 females, 38 males), aged 63.3\xa0±\xa07.9 y. 25(OH)D3']","['Supplemental 25-Hydroxycholecalciferol', 'Cholecalciferol', 'cholecalciferol (D3']","['rate to reach steady state', 'elimination rate of 25(OH)D3', '25(OH)D to steady state', 'rate of elimination', 'Serum 25-Hydroxyvitamin D Concentrations', 'time to reach 25(OH)D concentrations', 'effectiveness of D3 and 25(OH)D3 in raising 25-hydroxyvitamin D [25(OH)D] serum concentrations and achieving steady state']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}]",91.0,0.0354574,"The rate to reach steady state was similar in all groups, but the time to reach 25(OH)D concentrations of 75 nmol/L was faster in the higher-dosed 25(OH)D3 groups than in the D3 group (7 and 10 d compared with 40 d, P < 0.0001 and P < 0.0001 for 15 and 20 µg/d).","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Graeff-Armas', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bendik', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kunz', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Rotraut', 'Initials': 'R', 'LastName': 'Schoop', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hull', 'Affiliation': 'Leatherhead Food Research, Surrey, United Kingom.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'DSM Nutritional Products Ltd., Human Nutrition and Health, Basel, Switzerland.'}]",The Journal of nutrition,['10.1093/jn/nxz209']
1211,31518644,Lenalidomide and Vorinostat Maintenance after Autologous Transplantation in Multiple Myeloma: Long- Term Follow-Up.,"Post-autologous stem cell transplantation (ASCT) maintenance therapy with lenalidomide is standard of care for patients with multiple myeloma (MM). Effective and tolerable drug combinations may further enhance the clinical response post-ASCT. Vorinostat, a histone deacetylase inhibitor, induces antiproliferative and proapoptotic effects in patients with MM. We hypothesized that combination maintenance therapy would further prolong the clinical response achieved from transplantation. We previously reported that the combination of lenalidomide and vorinostat as maintenance post-ASCT was tolerable in 16 patients with MM. We now present the long-term follow up of these patients. Progression-free survival (PFS) and overall survival (OS) outcomes were characterized using the Kaplan-Meier method. Five patients (31%) had high-risk disease, and the median number of lines of therapy before ASCT was 1 (range, 1 to 5). With a median follow-up of 89.8 months from ASCT, the median PFS was 64.3 months (range, 21.7 months to not reached [NR]), and OS was not reached (median, 53.0 months to NR). At the time of this report, 5 patients remained on the study. The combination of vorinostat and lenalidomide as maintenance post-ASCT is tolerable and induces a durable response. A phase III randomized study of lenalidomide versus a combination with vorinostat is warranted.",2020,"With a median follow-up of 89.8 months from ASCT, the median PFS was 64.3 months (range, 21.7 months to not reached [NR]), and OS was not reached (median, 53.0 months to NR).","['patients with multiple myeloma (MM', '16 patients with MM', 'Multiple Myeloma', 'patients with MM']","['Post-autologous stem cell transplantation (ASCT) maintenance therapy with lenalidomide', 'Lenalidomide and Vorinostat Maintenance after Autologous Transplantation', 'lenalidomide']","['overall survival (OS) outcomes', 'median PFS', 'median number of lines of therapy', 'high-risk disease', 'Progression-free survival (PFS', 'clinical response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0595754,"With a median follow-up of 89.8 months from ASCT, the median PFS was 64.3 months (range, 21.7 months to not reached [NR]), and OS was not reached (median, 53.0 months to NR).","[{'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. Electronic address: nidhi.sharma@osumc.edu.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Nita Y', 'Initials': 'NY', 'LastName': 'Williams', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rosko', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Don M', 'Initials': 'DM', 'LastName': 'Benson', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Bumma', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Devarakonda', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Saly Lake City, Utah.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.09.005']
1212,31806543,"Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


Denosumab is a fully human monoclonal antibody that binds to, and inhibits, the receptor activator of RANKL (TNFSF11) and might affect breast cancer biology, as shown by preclinical evidence. We aimed to assess whether denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments would increase bone metastasis-free survival in women with breast cancer.
METHOD


In this international, double-blind, randomised, placebo-controlled, phase 3 study (D-CARE), patients were recruited from 389 centres in 39 countries. We enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. On eligibility confirmation, investigators at each site telephoned an interactive voice response system to centrally randomly assign patients (1:1) based on a fixed stratified permuted block randomisation list (block size 4) to receive either denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy, for about 6 months and then every 12 weeks for a total duration of 5 years. Stratification factors were breast cancer therapy, lymph node status, hormone receptor and HER2 status, age, and geographical region. The primary endpoint was the composite endpoint of bone metastasis-free survival. This trial is registered with ClinicalTrials.gov, NCT01077154.
FINDINGS


Between June 2, 2010, and Aug 24, 2012, 4509 women were randomly assigned to receive denosumab (n=2256) or placebo (n=2253) and included in the intention-to-treat analysis. The primary analysis of the study was done when all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017. The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70). The most common grade 3 or worse treatment-emergent adverse events, reported in patients who had at least one dose of the investigational product (2241 patients with denosumab vs 2218 patients with placebo), were neutropenia (340 [15%] vs 328 [15%]), febrile neutropenia (112 [5%] vs 142 [6%]), and leucopenia (62 [3%] vs 61 [3%]). Positively adjudicated osteonecrosis of the jaw occurred in 122 (5%) of 2241 patients treated with denosumab versus four (<1%) of 2218 patients treated with placebo; treatment-emergent hypocalcaemia occurred in 152 (7%) versus 82 (4%). Two treatment-related deaths occurred in the placebo group due to acute myeloid leukaemia and depressed level of consciousness.
INTERPRETATION


Despite preclinical evidence suggesting RANKL inhibition might delay bone metastasis or disease recurrence in patients with early-stage breast cancer, in this study, denosumab did not improve disease-related outcomes for women with high-risk early breast cancer.
FUNDING


Amgen.",2020,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","['enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'women with breast cancer', 'patients with early-stage breast cancer', 'all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017', 'early breast cancer (D-CARE', 'Between June 2, 2010, and Aug 24, 2012, 4509 women', 'patients were recruited from 389 centres in 39 countries', 'women with high-risk early breast cancer']","['Adjuvant denosumab', 'placebo', 'denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy', 'denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments', 'denosumab']","['febrile neutropenia', 'bone metastasis-free survival', 'deaths', 'acute myeloid leukaemia and depressed level of consciousness', 'neutropenia', 'composite endpoint of bone metastasis-free survival', 'emergent hypocalcaemia', 'leucopenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0549249', 'cui_str': 'Depressed Level of Consciousness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",2218.0,0.71545,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nayoya, Japan.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Hospital Pérola Byington and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Alvaro Montaño', 'Initials': 'AM', 'LastName': 'Periañez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Tonkin', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Deleu', 'Affiliation': 'Oncology Center, AZ Nikolass, Sint-Niklaas, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': 'All-Ireland Co-Operative Oncology Research Group, Dublin, Ireland.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jandial', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre Western Australia and School of Medicine, Curtin University, Perth, WA, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30687-4']
1213,31785594,Neonatal encephalopathy therapy optimization for better neuroprotection with inhalation of CO 2 : the HENRIC feasibility and safety trial.,"BACKGROUND


There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO 2  and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia.
METHODS


Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO 2  and 95% air was administered through patient circuits if the temperature-corrected PCO 2  ≤40 mm Hg. The CO 2  inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased <5 mmol/L. Follow-up was performed using Bayley Scales of Infant Development II.
RESULTS


The patients spent a median 95.1% (range 44.6-98.5%) of time in the desired PCO 2  range (40-60 mm Hg) during the inhalation. All PCO 2  values were >40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%.
CONCLUSIONS


Our results suggest that inhaled 5% CO 2  administration is a feasible and safe intervention for correcting hypocapnia.",2020,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","['mechanically ventilated infants with NE undergoing therapeutic hypothermia', 'infants with neonatal encephalopathy (NE']",[],"['rate of moderate disabilities and normal outcome', 'safety and feasibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy (disorder)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.143105,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","[{'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Kovacs', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Unoke', 'Initials': 'U', 'LastName': 'Meder', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Bokodi', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Andorka', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lakatos', 'Affiliation': 'MR Research Centre, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Attila J', 'Initials': 'AJ', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jermendy', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary. jermendy.agnes@med.semmelweis-univ.hu.'}]",Pediatric research,['10.1038/s41390-019-0697-9']
1214,31506240,Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial.,"Parkinson disease (PD) patients frequently experience micrographia and difficulty writing, which could potentially impact their quality of life. This study aimed to determine whether handwriting exercise could improve fine manual motor function in PD. The study was a randomized controlled trial assessing the efficacy of a 4-week handwriting exercise using a newly developed handwriting practice book. The primary endpoint was an improvement in the time used to complete the handwriting test. Secondary endpoints were accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination. Of a total of 46 subjects, 23 were randomly assigned to the handwriting exercise group. After 4 weeks, the mean time used to complete the test was significantly lower in the exercise group, compared to the control group (143.43 ± 34.02 vs. 175 ± 48.88 s, p = 0.015). Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001). Significant improvements were also observed by assessing the subjective rating scale and the UPDRS part III scores. The 4-week handwriting exercise using the studied handwriting practice book appears to promote an improvement in writing speed and motor function of hands. The optimal duration and frequency of the exercise, the quantity and characteristic of the letters in the handwriting practice book, and the benefits of the exercise in other languages merit further studies.",2020,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","['Parkinson disease', 'Of a total of 46 subjects']","['handwriting exercise', '4-week handwriting exercise', 'handwriting exercise group']","['functional outcome', 'Mean time used to complete the handwriting test', 'time used to complete the handwriting test', ""accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination"", 'mean time used to complete the test', 'writing speed and motor function of hands', 'subjective rating scale and the UPDRS part III scores']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",46.0,0.0240727,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Vorasoot', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichet', 'Initials': 'P', 'LastName': 'Termsarasab', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeratorn', 'Initials': 'T', 'LastName': 'Pulkes', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: teeratorn.pul@mahidol.ac.th.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.08.119']
1215,31478309,Implementation of Nurse-Driven HIV Screening Targeting Key Populations in Emergency Departments: A Multilevel Analysis From the DICI-VIH Trial.,"BACKGROUND


In countries with concentrated HIV epidemics, optimizing screening to reach individuals with undiagnosed infection is essential. The DICI-VIH study, a cluster-randomized crossover trial conducted in eight French emergency departments (EDs), found that a strategy combining nurse-driven targeted HIV screening with routine diagnostic testing was effective.
AIM


The aim was to investigate factors associated with the implementation of HIV screening targeting key populations in EDs.
METHODS


A self-administered questionnaire was distributed at registration to patients aged 18-64 years and able to give consent during the DICI-VIH intervention. Based on their responses, those belonging to key populations were offered a rapid test by triage nurses. Two key stages of the process were evaluated: questionnaire distribution by providers and test acceptance by patients. Patient information, daily workload, and ED characteristics were collected. The associations between these variables and (a) the proportion of questionnaires distributed and (b) the proportion of tests accepted were evaluated using multilevel modeling in order to examine differences in screening implementation between EDs.
RESULTS


Questionnaire distribution proportions varied from 23% to 48% across EDs. They were higher on weekdays than weekends (odds ratio, OR: 3.77; 95% CI: 3.57-3.99) and when research staff participated (OR: 1.31; 95% CI: 1.26-1.37). They decreased over time (OR: 0.76; 95% CI: 0.71-0.82; 4th [Q3] vs. 1st quartile [Q0] of intervention days) and with increased patient flow (OR: 0.61; 95% CI: 0.56-0.67; Q3 vs. Q0 of eligible patients). Test acceptance varied from 64% to 77% across EDs, increased with research staff participation (OR 1.20; 95% CI: 1.03-1.40), and decreased over time (OR: 0.75; 95% CI: 0.60-0.92; Q3 vs. Q0). Patients who accepted were more likely to be younger (OR: 0.76; 95% CI: 0.61-0.96; 50-64-year-old vs. 30-39-year-old patients).
LINKING EVIDENCE TO ACTION


Patient flow, intervention duration, weekdays, and research staff participation were important determinants of targeted screening implementation. These findings could help guide future implementation in similar settings.",2019,"Patients who accepted were more likely to be younger (OR: 0.76; 95% CI: 0.61-0.96; 50-64-year-old vs. 30-39-year-old patients).
","['eight French emergency departments (EDs', 'patients aged 18-64\xa0years and able to give consent during the DICI-VIH intervention', 'Emergency Departments', 'Patients who accepted were more likely to be younger (OR: 0.76; 95% CI: 0.61-0.96; 50-64-year-old vs. 30-39-year-old patients']",['Nurse-Driven HIV Screening'],"['Test acceptance', 'patient flow', 'Patient information, daily workload, and ED characteristics', 'research staff participation']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0459958', 'cui_str': 'HIV screening test'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0035168'}, {'cui': 'C4505269', 'cui_str': 'Employee Participation'}]",,0.183265,"Patients who accepted were more likely to be younger (OR: 0.76; 95% CI: 0.61-0.96; 50-64-year-old vs. 30-39-year-old patients).
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Leblanc', 'Affiliation': ""Research Chair in Innovative Nursing Practices, Research Centre of the Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'M Gabrielle', 'Initials': 'MG', 'LastName': 'Pagé', 'Affiliation': ""Department of Anesthesiology, Research Centre of the Centre hospitalier de l'Université de Montréal, Faculty of Medicine, Montreal, QC, Canada.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Piquet', 'Affiliation': 'Emergency Department, Hôpital St Antoine, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Clinical Pharmacology and Clinical Research Platform of East of Paris, Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Anne-Claude', 'Initials': 'AC', 'LastName': 'Crémieux', 'Affiliation': 'Université Paris Saclay-Université Versailles St Quentin, Montigny-le-Bretonneux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Worldviews on evidence-based nursing,['10.1111/wvn.12393']
1216,31774411,Mechanisms and Effects of a WeChat-Based Intervention on Suicide Among People Living With HIV and Depression: Path Model Analysis of a Randomized Controlled Trial.,"BACKGROUND


People living with HIV and depression have high rates of suicide. Studies of mobile health (mHealth) interventions have shown feasibility, acceptability, and efficacy in improving mental health in people living with HIV and depression. However, few studies have examined the mechanisms and effects of mHealth interventions on suicide.
OBJECTIVE


This study was designed to examine the mechanisms and effects of a WeChat-based intervention, Run4Love, on suicide among people living with HIV and depression in China, while considering perceived stress and depressive symptoms as mediators.
METHODS


A sample of 300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital and was randomized to the Run4Love group or a control group. Data were collected at baseline, 3-, 6-, and 9-month follow-ups. Path analysis modeling, with longitudinal data, was used in data analyses.
RESULTS


The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001). A partial mediating effect between perceived stress and depressive symptoms accounted for 33% (-0.09/-0.27) of the total effect.
CONCLUSIONS


Through path analyses, we understood the mechanisms and effects of an mHealth intervention on suicide prevention. The findings underscored the importance of stress reduction and depression treatment in such a program. We call for more effective suicide prevention, especially mHealth interventions targeting the vulnerable population of people living with HIV and depression.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showprojen.aspx?proj=21019.",2019,"The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001).","['people living with HIV and depression', '300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital', 'people living with HIV and depression in China', 'People Living With HIV and Depression']","['WeChat-Based Intervention', 'WeChat-based intervention, Run4Love', 'mobile health (mHealth) interventions', 'mHealth intervention']","['suicide rate', 'perceived stress and depressive symptoms', 'stress and depressive symptoms', 'Suicide']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",300.0,0.122319,"The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=-.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=-.09, P=.001).","[{'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Eight People's Hospital, Guangzhou, China.""}]",Journal of medical Internet research,['10.2196/14729']
1217,31962179,Cold fluids for induction of targeted temperature management: A sub-study of the TTH48 trial.,"BACKGROUND


Pre-intensive care unit (ICU) induction of targeted temperature management (TTM) with cold intravenous (i.v.) fluids does not appear to improve outcomes after in out-of-hospital cardiac arrest (OHCA). We hypothesized that this may be due to ineffective cooling and side effects.
METHODS


A post hoc analysis of a sub-group of patients (n = 352) in the TTH48 trial (NCT01689077) who received or did not receive pre-ICU cooling using cold i.v. fluids. Data collection included patient characteristics, cardiac arrest factors, cooling methods, side effects and continuous core temperature measurements. The primary endpoint was the time to target temperature (TTT, <34 °C), and the secondary endpoints included the incidence of circulatory side effects, abnormal electrolyte levels and hypoxia within the first 24 h of ICU care. A difference of 1 h in the TTT was determined as clinically significant a priori.
RESULTS


Of 352 patients included in the present analysis, 110 received pre-ICU cold fluids. The median time to the return of spontaneous circulation (ROSC) and TTT in the pre-ICU cold fluids group was longer than that of the group that did not receive pre-ICU cold fluids (318 vs. 281 min, p < 0.01). In a linear regression model including the treatment centre, body mass index (BMI), chronic heart failure, diabetes mellitus and time to ROSC, the use of pre-ICU cold i.v. fluids was not associated with a shorter time to the target temperature (standardized beta coefficient: 0.06, 95% CI for B -49 and 16, p  =  0.32). According to the receipt or not of pre-ICU cold i.v. fluids, there was no difference in the proportion of patients with hypoxia on ICU admission (1.8% vs. 3.3%, p =  0.43) or the proportion of patients with electrolyte abnormalities (hyponatremia: 1.8% vs. 2.9% p = 0.54; hypokalaemia: 1.8% vs. 4.5%, p =  0.20). Furthermore, there was no difference in hospital mortality between the groups.
CONCLUSIONS


The initiation of TTM with cold i.v. fluids before ICU arrival did not decrease the TTT. We detected no significant between-group difference in mortality or the incidence of side effects according to the administration or not of pre-ICU cold i.v fluids.",2020,We detected no significant between-group difference in mortality or the incidence of side effects according to the administration or not of pre-ICU cold i.v fluids.,"['352 patients included in the present analysis, 110 received pre-ICU cold fluids']",['Pre-intensive care unit (ICU) induction of targeted temperature management (TTM) with cold intravenous (i.v'],"['mortality or the incidence of side effects', 'time to target temperature (TTT, < 34\u2009°C', 'median time to the return of spontaneous circulation (ROSC) and TTT', 'incidence of circulatory side effects, abnormal electrolyte levels and hypoxia within the first 24\u2009h of ICU care', 'proportion of patients with hypoxia on ICU admission', 'hospital mortality', 'patient characteristics, cardiac arrest factors, cooling methods, side effects and continuous core temperature measurements', 'body mass index (BMI), chronic heart failure, diabetes mellitus and time to ROSC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0428284', 'cui_str': 'Finding of electrolyte levels (finding)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",352.0,0.0965774,We detected no significant between-group difference in mortality or the incidence of side effects according to the administration or not of pre-ICU cold i.v fluids.,"[{'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Holm', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Department of Emergency Medicine and Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway; Department Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duez', 'Affiliation': 'Research Center for Emergency Medicine, Department of Emergency Medicine and Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager C', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland; Department of Emergency Care and Services, University of Helsinki and Helsinki University Hospital, Finland. Electronic address: markus.skrifvars@hus.fi.'}]",Resuscitation,['10.1016/j.resuscitation.2019.11.031']
1218,31774408,"A Chatbot Versus Physicians to Provide Information for Patients With Breast Cancer: Blind, Randomized Controlled Noninferiority Trial.","BACKGROUND


The data regarding the use of conversational agents in oncology are scarce.
OBJECTIVE


The aim of this study was to verify whether an artificial conversational agent was able to provide answers to patients with breast cancer with a level of satisfaction similar to the answers given by a group of physicians.
METHODS


This study is a blind, noninferiority randomized controlled trial that compared the information given by the chatbot, Vik, with that given by a multidisciplinary group of physicians to patients with breast cancer. Patients were women with breast cancer in treatment or in remission. The European Organisation for Research and Treatment of Cancer Quality of Life Group information questionnaire (EORTC QLQ-INFO25) was adapted and used to compare the quality of the information provided to patients by the physician or the chatbot. The primary outcome was to show that the answers given by the Vik chatbot to common questions asked by patients with breast cancer about their therapy management are at least as satisfying as answers given by a multidisciplinary medical committee by comparing the success rate in each group (defined by a score above 3). The secondary objective was to compare the average scores obtained by the chatbot and physicians for each INFO25 item.
RESULTS


A total of 142 patients were included and randomized into two groups of 71. They were all female with a mean age of 42 years (SD 19). The success rates (as defined by a score >3) was 69% (49/71) in the chatbot group versus 64% (46/71) in the physicians group. The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
CONCLUSIONS


This is the first study that assessed an artificial conversational agent used to inform patients with cancer. The EORTC INFO25 scores from the chatbot were found to be noninferior to the scores of the physicians. Artificial conversational agents may save patients with minor health concerns from a visit to the doctor. This could allow clinicians to spend more time to treat patients who need a consultation the most.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03556813, https://tinyurl.com/rgtlehq.",2019,"The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
","['Patients', 'Patients were women with breast cancer in treatment or in remission', 'patients with breast cancer with a level of satisfaction similar to the answers given by a group of physicians', 'patients with cancer', 'With Breast Cancer', 'patients with breast cancer', 'A total of 142 patients', 'They were all female with a mean age of 42 years (SD 19']","['EORTC INFO25', 'artificial conversational agent', 'Artificial conversational agents']","['success rate', 'success rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",[],142.0,0.0746725,"The binomial test showed the noninferiority (P<.001) of the chatbot's answers.
","[{'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Bibault', 'Affiliation': 'Department of Radiation Oncology, Hôpital Européen Georges Pompidou, AP-HP, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaix', 'Affiliation': 'ENT Department, Hôpital Gui de Chauliac, Université Montpellier 1, Montpellier, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Guillemassé', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cousin', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Escande', 'Affiliation': 'Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Perrin', 'Affiliation': 'Department of Gynecological Oncologic Surgery, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Pienkowski', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Delamon', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nectoux', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Brouard', 'Affiliation': 'Wefight, Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière, Paris, France.'}]",Journal of medical Internet research,['10.2196/15787']
1219,31815726,Application of ultrasound fusion imaging technique for unilateral percutaneous vertebroplasty in treatment of osteoporotic thoracolumbar compression fracture.,"OBJECTIVE


To evaluate application of a computed tomography (CT)-ultrasound fusion imaging technique to unilateral percutaneous vertebroplasty (PVP) for treating patients with osteoporotic thoracolumbar compression fracture.
METHODS


Fourteen patients with osteoporotic thoracolumbar compression fractures were included, randomly divided into CT-ultrasound fusion imaging (n = 7) and traditional X-ray fluoroscopy groups (n = 7). Patients in the first group underwent unilateral PVP using real-time CT-ultrasound fusion imaging. A body surface locator was placed on the side contralateral to the scheduled puncture site (2-3 cm from the spinous process). Patient CT image information was recorded in the ultrasound system for registration during real-time ultrasound and CT fusion imaging, and one-click automatic registration was then performed. The puncture point and target point at which the puncture needle arrived were determined on CT images, with the puncture being performed under ultrasound guidance. Patients in the second group underwent X-ray fluoroscopy-guided PVP. Bone cement injection was injected under monitoring using a C-arm X-ray system. Patients' X-ray exposure and puncture times were recorded and compared between the two groups.
RESULTS


The average puncture times in the CT-ultrasound fusion imaging and traditional X-ray fluoroscopy groups were 2.50±0.31 min (without exposing patients and operators to radiation) and 5.00±0.65 min (with the same duration of radiation exposure), respectively. The average times for bone cement injection were 3.29±0.81 min and 3.50±0.86 min, respectively. The mean visual analog scale (VAS) scores were 2.10±0.11 and 2.20±0.21, respectively. The bone cement was evenly distributed without cement leakage in patients in the CT-ultrasound fusion imaging group, but a poor distribution of bone cement and bone cement leakage were found in one patient in the traditional X-ray fluoroscopy group.
CONCLUSIONS


Real-time CT-ultrasound fusion imaging is easy to perform, and provides precise localization of the puncture point, path, and target point. The selected puncture path was reasonable, and the needle had reached the target point accurately, which increased the success rate of puncture without radiation exposure.",2020,"The average puncture times in the CT-ultrasound fusion imaging and traditional X-ray fluoroscopy groups were 2.50±0.31 min (without exposing patients and operators to radiation) and 5.00±0.65 min (with the same duration of radiation exposure), respectively.","['patients with osteoporotic thoracolumbar compression fracture', 'Fourteen patients with osteoporotic thoracolumbar compression fractures', 'osteoporotic thoracolumbar compression fracture']","['computed tomography (CT)-ultrasound fusion imaging technique to unilateral percutaneous vertebroplasty (PVP', 'Bone cement injection', 'CT-ultrasound fusion imaging (n\u200a=\u200a7) and traditional X-ray fluoroscopy', 'X-ray fluoroscopy-guided PVP', 'unilateral PVP using real-time CT-ultrasound fusion imaging', 'ultrasound fusion imaging technique']","['bone cement', 'average times for bone cement injection', 'bone cement and bone cement leakage', 'mean visual analog scale (VAS) scores', 'average puncture times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0079595', 'cui_str': 'Imaging technique (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0005934', 'cui_str': 'Bone Pastes'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0005934', 'cui_str': 'Bone Pastes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",14.0,0.0144889,"The average puncture times in the CT-ultrasound fusion imaging and traditional X-ray fluoroscopy groups were 2.50±0.31 min (without exposing patients and operators to radiation) and 5.00±0.65 min (with the same duration of radiation exposure), respectively.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Departments of Ultrasound Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Mi', 'Affiliation': ""Departments of Musculoskeletal and Interventional Ultrasound, People's Hospital of Fengrun District, Hebei Province, China.""}, {'ForeName': 'Ruijun', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Departments of Ultrasound Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiuqing', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Departments of Musculoskeletal and Interventional Ultrasound, People's Hospital of Fengrun District, Hebei Province, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Departments of Musculoskeletal and Interventional Ultrasound, People's Hospital of Fengrun District, Hebei Province, China.""}]",Journal of X-ray science and technology,['10.3233/XST-190563']
1220,15533340,Histological dating of timed endometrial biopsy tissue is not related to fertility status.,"OBJECTIVE


To assess the ability of histological dating to discriminate between women of fertile and infertile couples. The utility of histological dating of endometrium in the evaluation of infertile couples is uncertain.
DESIGN


Prospective multicenter study, with subjects randomly assigned to biopsy timing. Criterion standard for infertility was 12 months of unprotected, regular intercourse without conception and for fertility at least one live birth within 2 years.
SETTING


University-based infertility practices.
PATIENT(S)


Volunteer subjects (847) recruited at 12 clinical sites participating in the National Institutes of Health-funded Reproductive Medicine Network. Inclusion criteria included ages 20-39 years, regular menstrual cycles, and no hormonal treatment or contraceptive use for 1 month before the study. Fertile controls were excluded if they had a history of infertility, recurrent pregnancy loss, or recent breastfeeding.
INTERVENTION(S)


Subjects underwent daily urinary LH testing. After detection of the LH surge, subjects were randomized to biopsy in the mid (days 21-22) or the late (days 26-27) luteal phase. Pathologists at each site estimated the cycle day based on standard criteria. For the primary analysis, an out-of-phase biopsy was defined as a greater than 2-day delay in the histological maturation of the endometrium.
MAIN OUTCOME MEASURE(S)


The proportion of out-of-phase biopsies in fertile and infertile women was compared using logistic regression models with age at randomization as a covariate. Comparisons were also made between fertile vs. infertile at the midluteal or late luteal phase time points.
RESULT(S)


Biopsies were evaluated (301 mid and 318 late; N = 619). Out-of-phase biopsy results poorly discriminated between women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0%). Results did not substantially differ using alternative definitions of ""out-of-phase"" or standardized cycle day.
CONCLUSION(S)


Histological dating of the endometrium does not discriminate between women of fertile and infertile couples and should not be used in the routine evaluation of infertility.",2004,"Out-of-phase biopsy results poorly discriminated between women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0%).","['\n\n\nVolunteer subjects (847) recruited at 12 clinical sites participating in the National Institutes of Health-funded Reproductive Medicine Network', 'Fertile controls were excluded if they had a history of infertility, recurrent pregnancy loss, or recent breastfeeding', 'women of fertile and infertile couples', 'infertile couples', 'women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0', 'University-based infertility practices', 'Inclusion criteria included ages 20-39 years, regular menstrual cycles, and no hormonal treatment or contraceptive use for 1 month before the study']",['daily urinary LH testing'],[],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",[],847.0,0.0415691,"Out-of-phase biopsy results poorly discriminated between women from fertile and infertile couples in either the midluteal (fertile: 49.4%, infertile: 43.2%) or late luteal phase (fertile: 35.3%, infertile 23.0%).","[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia 19104, USA. ccoutifaris@obgyn.upenn.edu'}, {'ForeName': 'Evan R', 'Initials': 'ER', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Guzick', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': ''}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Carson', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': ''}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'McGovern', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': ''}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Steinkampf', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Vogel', 'Affiliation': ''}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Leppert', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,[]
1221,31504721,"Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide.","BACKGROUND


While excess dietary sodium impairs vascular function by increasing oxidative stress, the dietary incorporation of dairy foods improves vascular health. We demonstrated that single-meal cheese consumption ameliorates acute, sodium-induced endothelial dysfunction. However, controlled feeding studies examining the inclusion of cheese, a dairy product that contains both bioactive constituents and sodium, are lacking.
OBJECTIVES


We tested the hypothesis that microcirculatory endothelium-dependent dilation (EDD) would be impaired by a high-sodium diet, but a sodium-matched diet high in dairy cheese would preserve EDD through oxidant stress mechanisms.
METHODS


We gave 11 adults without salt-sensitive blood pressure (<10 mmHg Δ mean arterial pressure; 64 ± 2 y) 4 separate 8-d controlled dietary interventions in a randomized, crossover design: a low-sodium, no-dairy intervention (LNa; 1500 mg/d sodium); a low-sodium, high-cheese intervention (LNaC; 1500 mg/d sodium, 170 g/d cheese); a high-sodium, no-dairy intervention (HNa; 5500 mg/d sodium); and a high-sodium, high-cheese intervention (HNaC; 5500 mg/d sodium, 170 g/d cheese). On Day 8 of each diet, EDD was assessed through a localized infusion (intradermal microdialysis) of acetylcholine (ACh), both alone and during coinfusion of NG-nitro-L-arginine methyl ester (NO synthase inhibitor), L-ascorbate (nonspecific antioxidant), apocynin [NAD(P)H oxidase inhibitor], or tempol (superoxide scavenger).
RESULTS


Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50). Further, ascorbate, apocynin, and tempol administration each increased ACh-induced vasodilation during HNa only (Ringer's: 38.9 ± 2.4; ascorbate: 48.0 ± 2.5; tempol: 45.3 ± 2.7; apocynin: 48.5 ± 2.6% maximum cutaneous vascular conductance; all P values < 0.01).
CONCLUSIONS


These results demonstrate that incorporating dairy cheese into a high-sodium diet preserves EDD by decreasing the concentration of superoxide radicals. Consuming sodium in cheese, rather than in nondairy sources of sodium, may be an effective strategy to reduce cardiovascular disease risk in salt-insensitive, older adults. This trial was registered at clinicaltrials.gov as NCT03376555.",2020,"Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50).",['11 adults without salt-sensitive blood pressure (<10 mmHg Δ mean arterial pressure; 64\xa0±\xa02 y) 4'],"['High-Dairy Cheese Diet', 'acetylcholine (ACh), both alone and during coinfusion of NG-nitro-L-arginine methyl ester (NO synthase inhibitor), L-ascorbate (nonspecific antioxidant), apocynin [NAD(P)H oxidase inhibitor], or tempol (superoxide scavenger', 'low-sodium, no-dairy intervention (LNa; 1500 mg/d sodium); a low-sodium, high-cheese intervention (LNaC; 1500 mg/d sodium, 170 g/d cheese); a high-sodium, no-dairy intervention (HNa; 5500 mg/d sodium); and a high-sodium, high-cheese intervention (HNaC; 5500 mg/d sodium', 'separate 8-d controlled dietary interventions']",['concentration of superoxide radicals'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0083536', 'cui_str': 'NG-Nitro-L-Arginine Methyl Ester'}, {'cui': 'C0132555', 'cui_str': 'Nitric Oxide Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0050465', 'cui_str': 'apocynine'}, {'cui': 'C0131722', 'cui_str': 'NADH oxidase'}, {'cui': 'C0045283', 'cui_str': '4-hydroxy-2,2,6,6-tetramethylpiperidinyl-1-oxy'}, {'cui': 'C0038836', 'cui_str': 'Superoxide Anion'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0765942', 'cui_str': 'latent nuclear protein, LNA'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038836', 'cui_str': 'Superoxide Anion'}]",11.0,0.0228987,"Compared with LNa, microvascular responsiveness to ACh was attenuated during HNa (LNa: -4.82 ± 0.20 versus HNa: -3.21 ± 0.55 M logEC50; P = 0.03) but not LNaC (-5.44 ± 0.20 M logEC50) or HNaC (-4.46 ± 0.50 M logEC50).","[{'ForeName': 'Billie K', 'Initials': 'BK', 'LastName': 'Alba', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Stanhewicz', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Priyankar', 'Initials': 'P', 'LastName': 'Dey', 'Affiliation': 'Human Nutrition Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Bruno', 'Affiliation': 'Human Nutrition Program, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz205']
1222,30989165,Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial.,"BACKGROUND


memory training is a potential intervention for retaining memory and reducing dementia risk in older adults with mild cognitive impairment (MCI).
OBJECTIVE


this study examined the effect of virtual interactive working memory training (VIMT) in older adults with MCI.
DESIGN


single-blind, two-arm parallel-group, randomised controlled design.
SETTING


retirement homes, institutions, and communities.
SUBJECTS


a total of 66 older adults with MCI were recruited (mean age: 78.5 ± 7.6 years).
METHODS


participants were randomly assigned to the experimental group (VIMT, n = 33) or active control group (n = 33). The VIMT program used the CogniPlus (includes four training modules). Both groups attended 45 min sessions 3 times per week, a total of 36 sessions. The primary outcome was working memory; secondary outcomes were immediate memory, delayed memory, subjective memory complaints and global cognitive function. All variables were measured at pre-test, post-test, and 3-month follow-up.
RESULTS


between group, the effect of working memory adjusted mean difference by 1.75 (95% CI: 0.56 to 2.94; P < 0.01) at post-test. The results were analysed by a generalised estimating equation, which indicated that VIMT group significantly improved working memory at post-test (P = 0.01) relative to the active control group.
CONCLUSIONS


the applied VIMT program can enable older adults with MCI to maintain their working memory and reduce the rate of cognitive deterioration.
TRIAL REGISTRATION


This trial was registered on ClinicalTrials.gov (no.: NCT02462135).",2019,"The results were analysed by a generalised estimating equation, which indicated that VIMT group significantly improved working memory at post-test (P = 0.01) relative to the active control group.
","['older adults with MCI', 'a total of 66 older adults with MCI were recruited (mean age: 78.5 ± 7.6 years', 'retirement homes, institutions, and communities', 'older people with mild cognitive impairment', 'participants', 'older adults with mild cognitive impairment (MCI']","['VIMT', 'virtual interactive working memory training', 'VIMT program', 'active control group', 'virtual interactive working memory training (VIMT']","['working memory; secondary outcomes were immediate memory, delayed memory, subjective memory complaints and global cognitive function', 'working memory']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0338046', 'cui_str': 'Residential home (environment)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",66.0,0.123354,"The results were analysed by a generalised estimating equation, which indicated that VIMT group significantly improved working memory at post-test (P = 0.01) relative to the active control group.
","[{'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hsin', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Institute of Aerospace and Undersea Medicine, School of Medicine, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Ching-Chiu', 'Initials': 'CC', 'LastName': 'Kao', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Huei-Ling', 'Initials': 'HL', 'LastName': 'Chiu', 'Affiliation': 'School of Gerontology Health Management, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ing-Jy', 'Initials': 'IJ', 'LastName': 'Tseng', 'Affiliation': 'School of Gerontology Health Management, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Tseng', 'Affiliation': 'Graduate Institute of Humanities in Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Kuei-Ru', 'Initials': 'KR', 'LastName': 'Chou', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}]",Age and ageing,['10.1093/ageing/afz029']
1223,32103441,Instability in End-of-Life Care Preference Among Heart Failure Patients: Secondary Analysis of a Randomized Controlled Trial in Singapore.,"BACKGROUND


Efforts to improve quality of end-of-life (EOL) care are increasingly focused on eliciting patients' EOL preference through advance care planning (ACP). However, if patients' EOL preference changes over time and their ACP documents are not updated, these documents may no longer be valid at the time EOL decisions are made.
OBJECTIVES


To assess extent and correlates of changes in stated preference for aggressive EOL care over time.
DESIGN


Secondary analysis of data from a randomized controlled trial of a formal ACP program versus usual care in Singapore.
PATIENTS


Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4 months for up to 2 years to assess their preference for EOL care. Analytic sample included 200 patients interviewed at least twice.
RESULTS


Nearly two thirds (64%) of patients changed their preferred type of EOL care at least once. Proportion of patients changing their stated preference for type of EOL care increased with time and the change was not unidirectional. Patients who understood their prognosis correctly were less likely to change their preference from non-aggressive to aggressive EOL care (OR 0.66, p value 0.07) or to prefer aggressive EOL care (OR 0.53; p value 0.001). On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
CONCLUSION


The study provides evidence of instability in HF patients' stated EOL care preference. This undermines the value of an ACP document recorded months before EOL decisions are made unless a strategy exists for easily updating this preference.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02299180.",2020,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","['Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4\xa0months for up to 2\xa0years to assess their preference for EOL care', 'Heart Failure Patients', '200 patients interviewed at least twice']",['formal ACP program versus usual care in Singapore'],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]",[],282.0,0.0539074,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","[{'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. chetna.malhotra@duke-nus.edu.sg.'}, {'ForeName': 'Meibo', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre Singapore, 5 Hospital Drive, Singapore, 169609, Singapore.'}, {'ForeName': 'Fazlur Rehman', 'Initials': 'FR', 'LastName': 'Jaufeerally', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Filipinas G', 'Initials': 'FG', 'LastName': 'Bundoc', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-020-05740-2']
1224,31497935,Adaptation and Implementation of a Family Caregiver Skills Training Program: From Single Site RCT to Multisite Pragmatic Intervention.,"PURPOSE


We describe an approach to rapidly adapt and implement an education and skills improvement intervention to address the needs of family caregivers of functionally impaired veterans-Helping Invested Families Improve Veterans' Experience Study (HI-FIVES).
DESIGN


Prior to implementation in eight sites, a multidisciplinary study team made systematic adaptations to the curriculum content and delivery process using input from the original randomized controlled trial (RCT); a stakeholder advisory board comprised of national experts in caregiver education, nursing, and implementation; and a veteran/caregiver engagement panel. To address site-specific implementation barriers in diverse settings, we applied the Replicating Effective Programs implementation framework.
FINDINGS


Adaptations to HI-FIVES content and delivery included identifying core/noncore curriculum components, reducing instruction time, and simplifying caregiver recruitment for clinical settings. To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely. Curriculum materials were standardized and packaged to reduce the time required for implementation and to promote fidelity to the intervention.
CONCLUSIONS


The emphasis on flexible intervention delivery and standardized materials has been identified as strengths of the adaptation process. Two key challenges have been identifying feasible impact measures and reaching eligible caregivers for intervention recruitment.
CLINICAL RELEVANCE


This systematic implementation process can be used to rapidly adapt an intervention to diverse clinical sites and contexts. Nursing professionals play a significant role in educating and supporting caregivers and care recipients and can take a leading role to implement interventions that address skills and unmet needs for caregivers.",2020,"To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely.",['family caregivers of functionally impaired veterans'],['Family Caregiver Skills Training Program'],[],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0303533,"To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Shepherd-Banigan', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Assistant Professor, Department of Population Health Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Brystana G', 'Initials': 'BG', 'LastName': 'Kaufman', 'Affiliation': 'Postdoctoral Research Fellow, Margolis Center for Health Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Decosimo', 'Affiliation': 'Research Health Scientist Specialist, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Dadolf', 'Affiliation': 'Clinical Social Worker/Intervention Specialist, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Boucher', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Assistant Research Professor, Sanford School of Public Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Mahanna', 'Affiliation': 'Research Health Scientist Specialist, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bruening', 'Affiliation': 'Research Health Scientist Specialist, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sullivan', 'Affiliation': 'Research Health Scientist Specialist, Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wang', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Associate Professor, Department of Population Health Sciences, Duke University, and Associate Professor, Division of General Internal Medicine, Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Associate Professor, Division of Geriatrics, Department of Medicine, Duke University, and Associate Professor, Department of Population Health Sciences, Duke University, and Senior Fellow, Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, Durham, NC, and Professor, Division of Rheumatology, Allergy, and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sperber', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Assistant Professor, Department of Population Health Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Research Health Scientist, Durham VA Health Care System, and Associate Professor, Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Courtney H', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Core Faculty, Margolis Center for Health Policy, Duke University, Durham, NC, USA.'}]",Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing,['10.1111/jnu.12511']
1225,32436655,"Novel, digital, chest drainage system in cardiac surgery.","BACKGROUND


A new, self-contained, digital, continuous pump-driven chest drainage system is compared in a randomized control trial to a traditional wall-suction system in cardiac surgery.
METHODS


One hundred and twenty adult elective cardiac patients undergoing coronary artery bypass graft and/or valve surgery were randomized to the study or control group. Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  . Additionally, a satisfaction assessment score (0-10) was performed by 52 staff members.
RESULTS


Given homogenous intra-operative variables, total chest-tube drainage was comparable among groups (566 vs 640 mL; ns), but the study group showed more efficient fluid collection during the early postoperative phase due to continuous suction (P = .01). Blood, cell saver transfusions and postoperative hemoglobin values were similar in both groups. The study group experienced drain removal after 29.8 vs 38.4 hours in the control group (ns). Seven crossovers from the Study to the Control group were registered but no patient had drain-related complications. The Personnel Satisfaction Assessment scored above 5 for all questions asked.
CONCLUSIONS


The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems. Quicker drain removal might impact on intensive care unit (ICU) stay and reduce costs. Additional advantages are portable size, battery operation, patient mobility, noiseless function, digital indications and alarms. The satisfaction assessment of the new system by the staff revealed a higher score when compared to the traditional wall suction chest drainage system.",2020,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","['Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  ', 'and/or valve surgery', 'One hundred and twenty adult elective cardiac patients undergoing', 'cardiac surgery']",['coronary artery bypass graft'],"['drain-related complications', 'drain removal', 'Blood, cell saver transfusions and postoperative hemoglobin values', 'total chest-tube drainage', 'intensive care unit (ICU) stay and reduce costs', 'satisfaction assessment score', 'efficient fluid collection']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",120.0,0.0347734,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Barozzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Livio San', 'Initials': 'LS', 'LastName': 'Biagio', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Meneguzzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Quality of Care Unit, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Beat H', 'Initials': 'BH', 'LastName': 'Walpoth', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faggian', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}]",Journal of cardiac surgery,['10.1111/jocs.14629']
1226,31503408,A texting-based blood pressure surveillance intervention.,"The authors examined whether using home BP measurements collected via a custom-built bi-directional-texting platform incorporated into patients' electronic medical records would lead to treatment calibration and improved BP management. Patients were randomized to either the intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements. Outcomes included number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control. 72% of the intervention group submitted at least 14 readings, compared with 45% of the control group. BP control improved in both groups. However, the authors found no statistically significant difference in BP or the number of BP-medication changes at 1, 3, or 6 months compared with the control group.",2019,BP control improved in both groups.,[],"['intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements', 'A texting-based blood pressure surveillance intervention']","['number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control', 'BP or the number of BP-medication changes', 'BP control']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",7.0,0.0398183,BP control improved in both groups.,"[{'ForeName': 'Roula S', 'Initials': 'RS', 'LastName': 'Zahr', 'Affiliation': 'Department of Internal Medicine, Oregon Health Sciences University, Portland, OR, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedic Surgery, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Goerdt', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Angela B', 'Initials': 'AB', 'LastName': 'Hoth', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Suneja', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Segre', 'Affiliation': 'Department of Computer Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13674']
1227,32436309,The effect of plasma rich platelet graft on post-operative complications in mid-penile hypospadias.,"Hypospadias is one of the most common penile congenital anomalies, which often requires a surgical approach. After the hypospadias is repaired, urethral fistula can occur in around 20% of patients. In this study, we used platelet-rich plasma (PRP) to reduce the urethral fistula and other post-operative complications after hypospadias repair. Only patients with primary mid-penile hypospadias were included study. Patients with forms other than mid-penile hypospadias and cases with previous hypospadias surgery were excluded from the study. A total of 40 hypospadias patients were included in this study. These patients were divided into groups A and B with 20 patients in each group. Hypospadias repair was performed with the Snodgrass TIPU technique on both groups. PRP was used with group A, and PRP was not use with group B. These two groups were compared in terms of early and long-term post-operative complications. Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.",2020,"Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.","['Patients with forms other than mid-penile hypospadias and cases with previous hypospadias surgery', 'Only patients with primary mid-penile hypospadias', '40 hypospadias patients', 'hypospadias repair', 'mid-penile hypospadias']","['PRP', 'plasma rich platelet graft', 'platelet-rich plasma (PRP']",['urethral stenosis and post-operative infection rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1691215', 'cui_str': 'Hypospadias, penile'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",40.0,0.0244697,"Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.","[{'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Şimşek', 'Affiliation': 'Department of Pediatric Surgery, Van Education and Research Hospital, Van, Turkey.'}, {'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Aslan', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Beger', 'Affiliation': 'Department of Pediatric Surgery, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Kasım', 'Initials': 'K', 'LastName': 'Ertaş', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Taken', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}]",Andrologia,['10.1111/and.13652']
1228,31502906,A Comparative Effectiveness Trial of Two Patient-Centered Interventions for Women with Unmet Social Needs: Personalized Support for Progress and Enhanced Screening and Referral.,"Background:  Despite recent widespread acceptance that unmet social needs are critically relevant to health, limited guidance exists about how best to address them in the context of women's health care delivery. We aimed to evaluate two interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities.  Materials and Methods:  Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients. If eligible and interested, we enrolled and randomized women to ESR or PSP. Pre- and postintervention assessments were conducted. Primary outcomes were satisfaction, depression, and quality of life (QOL). Planned analyses of subgroup differences were also explored.  Results:  A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina. Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment. Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001). There were no differences between groups for the primary outcomes. Subgroups reporting greater improvement in QOL in PSP compared with ESR included participants who at baseline reported anxiety ( p  = 0.05), lack of access to depression treatment ( p  = 0.02), pain ( p  = 0.04), and intimate partner violence ( p  = 0.02).  Conclusions:  Clinics serving women with unmet social needs may benefit from offering PSP or ESR. Distinguishing how best to use these interventions in practice is the next step.",2020,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"['Women with Unmet Social Needs', ""Women >18 years were screened for presence of elevated depressive symptoms in three women's health clinics serving primarily Medicaid-eligible patients"", 'Participant mean age was 30 years; 77% reported annual incomes below US $20,000/year; and 30% were pregnant at enrollment', 'A total of 235 participants were randomized; 54% identified as African American, 19% as White, and 15% as Latina']","[""interventions: enhanced screening and referral (ESR), a screening intervention with facilitated referral and follow-up calls, and personalized support for progress (PSP), a community health worker intervention tailored to women's priorities"", 'ESR or PSP', 'Two Patient-Centered Interventions']","['lack of access to depression treatment', 'depression', 'pain', 'QOL in PSP', 'anxiety', 'satisfaction, depression, and quality of life (QOL', 'intimate partner violence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",235.0,0.12693,Participants in both arms found the interventions satisfactory and improved for depression ( p  < 0.001).,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Poleshuck', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Hugh F', 'Initials': 'HF', 'LastName': 'Crean', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Juskiewicz', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7640']
1229,31502659,Long-term follow-up of two randomized trials comparing laparoscopic Nissen 360° with anterior 90° partial fundoplication.,"BACKGROUND


The side-effects of Nissen fundoplication have led to modifications, including partial fundoplications such as an anterior 90° wrap. Five-year follow-up of two randomized trials suggested fewer side-effects following anterior 90° partial fundoplication, but better reflux control after Nissen fundoplication. However, longer-term outcomes have not been reported. This study combined data from previous trials to determine 10-year outcomes.
METHODS


From 1999 to 2003, 191 patients were enrolled in two randomized trials comparing anterior 90° partial versus Nissen fundoplication. Trial protocols were similar, and data were combined to determine long-term clinical outcomes. Patients completed annual questionnaires assessing dysphagia, heartburn, medications, satisfaction and other symptoms. Visual analogue scales (0-10), a composite dysphagia score (0-45) and yes/no responses were used.
RESULTS


Of the 191 patients, 152 (79·6 per cent) were available for 10-year follow-up. After anterior 90° fundoplication, patients reported less dysphagia to solids (score 2·03 versus 3·18 for the Nissen procedure; P = 0·037). Heartburn scores were lower after Nissen fundoplication (1·90 versus 2·83 for anterior 90° fundoplication; P = 0·035) and fewer patients required proton pump inhibitors (PPIs) (22 versus 39 per cent respectively; P = 0·035). Satisfaction scores were similar for both anterior 90° and Nissen groups (7·45 versus 7·36 respectively; P = 0·566), and the majority considered their original decision for surgery to be correct (86 versus 84 per cent; P = 0·818).
CONCLUSION


After 10 years, both procedures achieved similar success as measured by global satisfaction measures. Patients who had a Nissen fundoplication reported more dysphagia, whereas more heartburn and PPI consumption were reported after anterior 90° fundoplication. Registration numbers: ACTRN12607000298415 and ACTRN12607000304437 (http://www.anzctr.org.au/).",2020,Heartburn scores were lower after Nissen fundoplication (1·90 versus 2·83 for anterior 90° fundoplication; P = 0·035) and fewer patients required proton pump inhibitors (PPIs) (22 versus 39 per cent respectively; P = 0·035).,"['Of the 191 patients, 152 (79·6 per cent) were available for 10-year follow-up', 'From 1999 to 2003, 191 patients']","['laparoscopic Nissen 360° with anterior 90° partial fundoplication', 'anterior 90° partial versus Nissen fundoplication', 'Nissen fundoplication']","['side-effects', 'heartburn and PPI consumption', 'annual questionnaires assessing dysphagia, heartburn, medications, satisfaction and other symptoms', 'dysphagia', 'Visual analogue scales', 'composite dysphagia score', 'Heartburn scores', 'dysphagia to solids', 'Satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0701808', 'cui_str': 'Partial fundoplication (procedure)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}]",191.0,0.159811,Heartburn scores were lower after Nissen fundoplication (1·90 versus 2·83 for anterior 90° fundoplication; P = 0·035) and fewer patients required proton pump inhibitors (PPIs) (22 versus 39 per cent respectively; P = 0·035).,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hopkins', 'Affiliation': 'Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}]",The British journal of surgery,['10.1002/bjs.11327']
1230,32436683,COPD exacerbation costs in the IMPACT study: a within-trial analysis.,"OBJECTIVES


Exacerbations account for the greatest proportion of costs associated with chronic obstructive pulmonary disease (COPD). Here we aimed to evaluate, from the US payer perspective, the costs associated with moderate and severe COPD exacerbation events for patients treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared with FF/VI or UMEC/VI.
STUDY DESIGN


This post hoc, within-trial economic analysis used data derived from the InforMing the PAthway of COPD Treatment (IMPACT) study (NCT02164513).
METHODS


Treatment groups within the IMPACT trial received either triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC/VI [62.5/25 mcg]). The primary end point for this IMPACT post hoc analysis was cost differences between the treatment arms related to 1-year on-treatment combined moderate and severe COPD exacerbation events.
RESULTS


The final study sample for this within-trial analysis consisted of 10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study. The mean 1-year on-treatment cost estimate associated with combined moderate and severe exacerbations was highest with UMEC/VI and lowest with FF/UMEC/VI ($6205 vs $4913, respectively). Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (-$549 [95% CI, -$565 to -$533] and -$1292 [95% CI, -$1313 to -$1272], respectively; both P <.0001).
CONCLUSIONS


Treatment with FF/UMEC/VI compared with FF/VI or UMEC/VI in the US healthcare system resulted in lower exacerbation-related costs for combined moderate/severe exacerbation events, as well as moderate and severe exacerbations separately.",2020,Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (,"['10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study', '549', 'chronic obstructive pulmonary disease (COPD']","['FF/VI or UMEC/VI', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI', 'triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC']","['severe exacerbations', 'Mean cost differences', 'COPD exacerbation costs', '1-year on-treatment combined moderate and severe COPD exacerbation events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",10355.0,0.527849,Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bogart', 'Affiliation': 'US Value Evidence and Outcomes, GlaxoSmithKline plc, 5 Moore Dr, Research Triangle Park, Durham, NC. Email: michael.r.bogart@gsk.com.'}, {'ForeName': 'Sari D', 'Initials': 'SD', 'LastName': 'Hopson', 'Affiliation': ''}, {'ForeName': 'Huai-Che', 'Initials': 'HC', 'LastName': 'Shih', 'Affiliation': ''}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Stanford', 'Affiliation': ''}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Coutinho', 'Affiliation': ''}]",The American journal of managed care,['10.37765/ajmc.2020.43157']
1231,31846029,Nudging Emergency Care Providers to Reduce Opioid Prescribing Using Peer Norm Comparison Feedback: A Pilot Randomized Trial.,"OBJECTIVE


To determine the feasibility, acceptability, and potential impact of using audit and feedback (A&F) with or without peer norm comparison on opioid prescribing by emergency medicine providers.
METHODS


A convenience sample of 37 emergency medicine providers were recruited from 16 emergency departments in Western Pennsylvania for a pilot randomized controlled trial. Participants completed a baseline survey, were randomly allocated to A&F (N = 17) or A&F with peer norm comparison (N = 20), and were asked to complete a postintervention survey. We matched each participant 1:1 to a control who was not exposed to either intervention.
RESULTS


At baseline, 57% of participants perceived that they prescribed opioids at the same frequency as their peers, whereas 32% perceived prescribing less than and 11% perceived prescribing more than their peers. Most participants rated the interventions as helpful, with no differences between conditions. For the A&F with peer norm comparison condition, from pre- to postintervention, there was a relative increase of 20% in the percentage of participants who perceived that they prescribed more opioids than their peers but no change in the A&F condition (P = 0.02). 56.8% of controls, 52.9% of A&F participants, and 75.5% of A&F with peer norm comparison participants reduced their opioid prescribing (P = 0.33). The mean reduction in opioid prescriptions (SD) was 3.3. (9.6) for controls, 3.9 (10.5) for A&F, and 7.3 (7.8) for A&F with peer norm comparison (P = 0.31).
CONCLUSIONS


Audit and feedback interventions with peer norm comparisons are helpful to providers, can alter perceptions about prescribing norms, and are a potentially effective way to alter ED providers' opioid prescribing behavior.",2020,A convenience sample of 37 emergency medicine providers were recruited from 16 emergency departments in Western Pennsylvania for a pilot randomized controlled trial.,['37 emergency medicine providers were recruited from 16 emergency departments in Western Pennsylvania'],"['Prescribing Using Peer Norm Comparison Feedback', 'audit and feedback (A&F) with or without peer norm comparison', 'A&F (N\u2009=\u200917) or A&F with peer norm comparison', 'Opioid']","['mean reduction in opioid prescriptions (SD', 'opioid prescribing']","[{'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",37.0,0.0640923,A convenience sample of 37 emergency medicine providers were recruited from 16 emergency departments in Western Pennsylvania for a pilot randomized controlled trial.,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Landau', 'Affiliation': 'School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz314']
1232,30995665,Blood Chromogranin A Is Not Effective as a Biomarker for Diagnosis or Management of Bronchopulmonary Neuroendocrine Tumors/Neoplasms.,"BACKGROUND


Identification of circulating tumor markers for clinical management in bronchopulmonary (BP) neuroendocrine tumors/neoplasms (NET/NEN) is of considerable clinical interest. Chromogranin A (CgA), a ""universal"" NET biomarker, is considered controversial as a circulating biomarker of BPNEN.
AIM


Assess utility of CgA in the diagnosis and management of BPNEN in a multicentric study.
MATERIAL AND METHODS


CgA diagnostic metrics were assessed in lung NET/NENs (n = 200) and controls (n = 140), randomly assigned to a Training and Test set (100 BPC and 70 controls in each). Assay specificity was evaluated in neoplastic lung disease (n = 137) and nonneoplastic lung disease (n = 77). CgA efficacy in predicting clinical status was evaluated in the combined set of 200 NET/NENs. CgA levels in bronchopulmonary neuroendocrine tumor (BPNET) subtypes (atypical [AC] vs. typical [TC]) and grade was examined. The clinical utility of an alteration of CgA levels (±25%) was evaluated in a subset of 49 BPNET over 12 months. CgA measurement was by NEOLISATM kit (EuroDiagnostica).
RESULTS


Sensitivity and specificity in the training set were 41/98%, respectively. Test set data were 42/87%. Training set area under receiver operator characteristic analysis differentiated BPC from control area under the curve (AUC) 0.61 ± 0.05 p = 0.015. Test set the data were AUC 0.58 ± 0.05, p = 0.076. In the combined set (n = 200), 67% BPNET/NEN (n = 134) had normal CgA levels. CgA levels did not distinguish histological subtypes (TC vs. AC, AUC 0.56 ± 0.04, p = 0.21), grade (p = 0.45-0.72), or progressive from stable disease (AUC 0.53 ± 0.05 p = 0.47). There was no correlation of CgA with Ki-67 index (Pearson r = 0.143, p = 0.14). For nonneoplastic diseases (chronic obstructive pulmonary disorder and idiopathic pulmonary fibrosis), CgA was elevated in 26-37%. For neoplastic disease (NSCLC, squamous cell carcinoma), CgA was elevated in 11-16%. The neuroendocrine SCLC also exhibited elevated CgA (50%). Elevated CgA was not useful for differentiating BPNET/NEN from these other pathologies. Monitoring BPNET/NEN over a 12-month period identified neither CgA levels per se nor changes in CgA were reflective of somatostatin analog treatment outcome/efficacy or the natural history of the disease (progression).
CONCLUSIONS


Blood CgA levels are not clinically useful as a biomarker for lung BPNET/NEN. The low specificity and elevations in both nonneoplastic as well as other common neoplastic lung diseases identified limited clinical utility for this biomarker.",2020,"CgA levels did not distinguish histological subtypes (TC vs. AC, AUC: 0.56±0.04, p=0.21), grade (p=0.45-0.72) or progressive from stable disease (AUC: 0.53±0.05 p=0.47).","['neoplastic lung disease (n=137) and non-neoplastic lung disease (n=77', 'bronchopulmonary (BP) neuroendocrine tumors/neoplasms (NET/NEN', 'CgA diagnostic metrics were assessed in lung NET/NENs (n=200) and controls (n=140']","['NEN', 'CgA', 'Monitoring BPNET', 'Chromogranin A (CgA']","['normal CgA levels', 'Sensitivity and specificity', 'CgA levels', 'CgA efficacy', 'Assay specificity', 'CgA with Ki-67 index']","[{'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0055633', 'cui_str': 'Secretory Protein I, Parathyroid Gland'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0373385,"CgA levels did not distinguish histological subtypes (TC vs. AC, AUC: 0.56±0.04, p=0.21), grade (p=0.45-0.72) or progressive from stable disease (AUC: 0.53±0.05 p=0.47).","[{'ForeName': 'Somer', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Malczewska', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Oberg', 'Affiliation': 'Department of Endocrine Oncology, University Hospital, Uppsala, Sweden, kjell.oberg@medsci.uu.se.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bodei', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Centre, New York, New York, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Aslanian', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lewczuk-Myślicka', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Filosso', 'Affiliation': 'Department of Thoracic Surgery, University of Turin, Turin, Italy.'}, {'ForeName': 'Alejandro L', 'Initials': 'AL', 'LastName': 'Suarez', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kolasińska-Ćwikła', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Roffinella', 'Affiliation': 'Department of Thoracic Surgery, University of Turin, Turin, Italy.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Kos-Kudła', 'Affiliation': 'Department of Endocrinology and Neuroendocrine Tumors, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Jarosław B', 'Initials': 'JB', 'LastName': 'Ćwikła', 'Affiliation': 'Department of Radiology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Ignat A', 'Initials': 'IA', 'LastName': 'Drozdov', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kidd', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Irvin M', 'Initials': 'IM', 'LastName': 'Modlin', 'Affiliation': 'Gastroenterological and Endoscopic Surgery, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Neuroendocrinology,['10.1159/000500202']
1233,31424354,Effects of mental fatigue on passing decision-making performance in professional soccer athletes.,"The aim of this study was to analyse the effect of mental fatigue on passing decision-making in professional soccer athletes. A controlled and counterbalanced cross-over design was adopted consisting of three visits with a 1-week interval between sessions. Twenty professional soccer male athletes participated in three randomized conditions divided into three visits: control, 15-min Stroop task, and 30-min Stroop task. Inhibitory control was accessed by the Stroop task (accuracy and response time) before and after induced mental fatigue protocol. The athletes played a training match (90-min) following the experimental conditions. The Game Performance Assessment Instrument (GPAI) was used for the passing decision-making analysis. The GPAI analysis showed impaired passing decision-making performance following the 30-min Stroop task compared with the 15-min and control condition ( F   (2,17)  = 6.99,  p  = .01). Moreover, an increase in response time during the Stroop task was found following 30-min Stroop task condition ( F   (2,17)  = 6.57,  p  = .03) compared to 15-min of Stroop task and control conditions. Prolonged cognitive tasks may be considered a mediating factor in passing decision-making performance in male professional soccer athletes throughout a full-length training match. Thus, athletes should avoid highly demanding-cognitive tasks before a soccer match. Future studies are required to explore more ecological cognitive tasks to induce mental fatigue (i.e. smartphones and video-games) and their effects on other performance indicators (e.g. physical, technical, tactical) in a full-length training match setting.",2020,"The GPAI analysis showed impaired passing decision-making performance following the 30-min Stroop task compared with the 15-min and control condition (F (2,17)  = 6.99, p = .01).","['Twenty (20) professional soccer male athletes', 'male professional soccer athletes', 'professional soccer athletes']","['mental fatigue', 'visits: control, 15-min Stroop task, and 30-min Stroop task']","['Stroop task (accuracy and response time', 'passing decision-making performance', 'response time']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0207162,"The GPAI analysis showed impaired passing decision-making performance following the 30-min Stroop task compared with the 15-min and control condition (F (2,17)  = 6.99, p = .01).","[{'ForeName': 'Petrus', 'Initials': 'P', 'LastName': 'Gantois', 'Affiliation': 'Associate Graduate Program in Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Caputo Ferreira', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Dalton de', 'Initials': 'D', 'LastName': 'Lima-Junior', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Fábio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Associate Graduate Program in Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Gilmário Ricarte', 'Initials': 'GR', 'LastName': 'Batista', 'Affiliation': 'Associate Graduate Program in Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Fabiano S', 'Initials': 'FS', 'LastName': 'Fonseca', 'Affiliation': 'Department of Physical Education, Rural Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Leonardo de Sousa', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Associate Graduate Program in Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}]",European journal of sport science,['10.1080/17461391.2019.1656781']
1234,31859246,"CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.","BACKGROUND


Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are indicated with endocrine therapy as first-line or second-line treatment for hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer. We aimed to investigate the benefit of adding CDKIs to endocrine therapy in patients whose tumours might have differing degrees of endocrine sensitivity.
METHODS


We pooled individual patient data from all phase 3 randomised breast cancer trials of CDKIs plus endocrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in support of marketing applications. Our pooled analysis included all randomly assigned patients in these trials who received at least one dose of CDKI or placebo with endocrine therapy (an aromatase inhibitor [letrozole or anastrazole] or fulvestrant). We did prespecified subgroup analyses in patients with progesterone receptor-negative disease; patients with a disease-free interval of 12 months or less; patients with de-novo metastases, lobular histology, and bone-only disease; patients with visceral metastases; and patients aged up to 40 years. Patients who were not treated, who received tamoxifen as endocrine therapy, or who were treated with an aromatase inhibitor but who had received previous chemotherapy in the metastatic setting (not first-line) were excluded from our pooled analyses. All studies had a primary endpoint of investigator-assessed progression-free survival, defined as time from date of randomisation to the initial date of documented cancer progression or death, whichever occurred first. Median progression-free survival was estimated with Kaplan-Meier methods. Hazard ratios (HR) with 95% CIs for progression-free survival were estimated by means of Cox regression models.
FINDINGS


The seven studies meeting this study's inclusion criteria were done between Feb 22, 2013, and Nov 3, 2017, with a median duration of follow-up of 19·7 months (IQR 15·9-25·9). 4200 patients were included in the pooled analysis, of whom 1320 received an aromatase inhibitor plus a CDKI, 932 received placebo plus an aromatase inhibitor, 1296 received fulvestrant plus a CDKI, and 652 received fulvestrant plus placebo. Across all seven pooled trials, the difference in estimated median progression-free survival was 8·8 months in favour of CDKI plus endocrine therapy over placebo plus endocrine therapy (range across the trials 6·8-13·3 months; HR 0·59, 95% CI 0·54-0·64). Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population. In first-line aromatase inhibitor-treated patients (n=2252), the median progression-free survival in the CDKI plus aromatase inhibitor group was 28·0 months (95% CI 25·3-29·1) versus 14·9 months (14·0-16·7) in the placebo plus aromatase inhibitor group (difference 13·1 months; range across the trials 13·0-13·3 months; HR 0·55, 95% CI 0·49-0·62). In first-line fulvestrant-treated patients (n=396), the median progression-free survival was 18·6 months (95% CI 14·8-23·5) in the placebo plus fulvestrant group and not estimable (22·4 to not estimable) in the CDKI plus fulvestrant group (difference not estimable; HR 0·58, 95% CI 0·42-0·80). In the patients treated with fulvestrant in the second-line setting and beyond (n=1552), the difference in estimated median progression-free survival between the CDKI plus fulvestrant group and the placebo plus fulvestrant group was 6·9 months in favour of the CDKI group (range across the trials 5·5-7·3 months; HR 0·56, 95% CI 0·49-0·64).
INTERPRETATION


Since the addition of CDKI to endocrine therapy seemed to benefit all clinicopathological subgroups of interest in this pooled analysis, further research is needed to identify patient subgroups for whom endocrine therapy alone might be appropriate for first-line or second-line treatment of hormone receptor-positive, HER2-negative metastatic breast cancer.
FUNDING


None.",2020,"Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population.","['patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer', 'patients whose tumours might have differing degrees of endocrine sensitivity', 'Patients who were not treated, who received tamoxifen as endocrine therapy, or who were treated with an aromatase inhibitor but who had received previous chemotherapy in the metastatic setting (not first-line', '4200 patients were included in the pooled analysis, of whom 1320 received an', 'patients with progesterone receptor-negative disease; patients with a disease-free interval of 12 months or less; patients with de-novo metastases, lobular histology, and bone-only disease; patients with visceral metastases; and patients aged up to 40 years']","['placebo plus fulvestrant', 'CDK4/6 inhibitor treatment', 'CDKI or placebo with endocrine therapy (an aromatase inhibitor [letrozole or anastrazole] or fulvestrant', 'aromatase inhibitor plus a CDKI, 932 received placebo plus an aromatase inhibitor, 1296 received fulvestrant plus a CDKI, and 652 received fulvestrant plus placebo', 'fulvestrant', 'placebo plus aromatase inhibitor', 'placebo plus endocrine therapy', 'CDKIs plus endocrine therapy']","['Median progression-free survival', 'median progression-free survival', 'Progression-free survival', 'investigator-assessed progression-free survival', 'progression-free survival', 'cancer progression or death', 'estimated median progression-free survival', 'Hazard ratios (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205417', 'cui_str': 'Lobular (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",4200.0,0.348473,"Progression-free survival results favoured the CDKI group in all prespecified clinicopathological subgroups analysed, with similar HRs to that for the broader intended-use population.","[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: jennifer.gao@fda.hhs.gov.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Palantir Technologies, Palo Alto, CA, USA.'}, {'ForeName': 'Suparna B', 'Initials': 'SB', 'LastName': 'Wedam', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Office of Translational Sciences, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA; Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of the Commissioner, Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Prowell', 'Affiliation': 'Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30804-6']
1235,31952047,The Effect of Sodium Bicarbonate Supplementation on the Decline in Gross Efficiency During a 2000-m Cycling Time Trial,"BACKGROUND


Gross efficiency (GE) declines during high-intensity exercise. Increasing extracellular buffer capacity might diminish the decline in GE and thereby improve performance.
PURPOSE


To examine if sodium bicarbonate (NaHCO3) supplementation diminishes the decline in GE during a 2000-m cycling time trial.
METHODS


Sixteen male cyclists and 16 female cyclists completed 4 testing sessions including a maximal incremental test, a familiarization trial, and two 2000-m GE tests. The 2000-m GE tests were performed after ingestion of either NaHCO3 supplements (0.3 g/kg body mass) or placebo supplements (amylum solani, magnesium stearate, and sunflower oil capsules). The GE tests were conducted using a double-blind, randomized, crossover design. Power output, gas exchange, and time to complete the 2000-m time trials were recorded. Capillary blood samples were analyzed for blood bicarbonate, pH, and lactate concentration. Data were analyzed using magnitude-based inference.
RESULTS


The decrement in GE found after the 2000-m time trial was possibly smaller in the male and female groups after NaHCO3 than with placebo ingestion, with the effect in both groups combined being unclear. The effect on performance was likely trivial for males (placebo 164.2 [5.0] s, NaHCO3 164.3 [5.0] s; Δ0.1; ±0.6%), unclear for females (placebo 178.6 [4.8] s, NaHCO3 178.0 [4.3] s; Δ-0.3; ±0.5%), and very likely trivial when effects were combined. Blood bicarbonate, pH, and lactate concentration were substantially elevated from rest to pretest after NaHCO3 ingestion.
CONCLUSIONS


NaHCO3 supplementation results in an unclear effect on the decrease in GE during high-intensity exercise and in a very likely trivial effect on performance.",2020,"The decrement in GE found after the 2000-m time trial was possibly smaller in the male and female groups after NaHCO3 than with placebo ingestion, with the effect in both groups combined being unclear.",['Sixteen male cyclists and 16 female cyclists'],"['NaHCO3 supplementation', 'sodium bicarbonate (NaHCO3) supplementation', 'placebo supplements (amylum solani, magnesium stearate, and sunflower oil capsules', 'Sodium Bicarbonate Supplementation', 'NaHCO3 supplements']","['blood bicarbonate, pH, and lactate concentration', 'GE', 'Blood bicarbonate, pH, and lactate concentration', 'Power output, gas exchange, and time to complete the 2000-m time trials', 'Gross Efficiency']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085799', 'cui_str': 'Amylum'}, {'cui': 'C0126791', 'cui_str': 'Magnesium stearate'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",16.0,0.43811,"The decrement in GE found after the 2000-m time trial was possibly smaller in the male and female groups after NaHCO3 than with placebo ingestion, with the effect in both groups combined being unclear.","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Voskamp', 'Affiliation': ''}, {'ForeName': 'Senna', 'Initials': 'S', 'LastName': 'van den Bos', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Foster', 'Affiliation': ''}, {'ForeName': 'Jos J', 'Initials': 'JJ', 'LastName': 'de Koning', 'Affiliation': ''}, {'ForeName': 'Dionne A', 'Initials': 'DA', 'LastName': 'Noordhof', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0177']
1236,31495898,Emulsion Droplet Crystallinity Attenuates Postprandial Plasma Triacylglycerol Responses in Healthy Men: A Randomized Double-Blind Crossover Acute Meal Study.,"BACKGROUND


The presence of triacylglycerol (TAG) cystallinity is assumed to influence digestibility and postprandial lipemia (PPL), although studies to date are limited.
OBJECTIVE


This study aimed to investigate whether the presence of solid fat compared with undercooled liquid oil, specifically, plays a role in determining PPL by comparing emulsion droplets differing only in terms of physical state.
METHODS


Ten percent palm stearin and 0.4% sorbitan monostearate emulsions were tempered to contain identically sized, charged, and shaped (spherical) undercooled liquid (LE) compared with partially crystalline solid (SE; mean ± SEM: 33.2% ± 0.03% solid fat at 37°C) droplets. Fifteen healthy fasting adult men (mean ± SD age: 27.5 ± 5.7 y; BMI: 24.1 ± 2.5 kg/m2) consumed 500 mL of each emulsion on separate occasions and plasma TAG concentrations, particle size of the plasma chylomicron-rich fraction (CMRF), and fatty acid (FA) composition of the CMRF-TAG were serially determined in a 6-h postprandial randomized double-blind crossover acute meal study. Changes from baseline values were analyzed by repeated-measures ANOVA.
RESULTS


An earlier (2 compared with 3 h, P < 0.05) significant rise, a 39.9% higher mean postprandial TAG change from baseline (P = 0.08), and higher peak concentration (mean ± SEM: 1.47 ± 0.19 compared with 1.20 ± 0.15 mmol/L, P = 0.04) and iAUC (1.95 ± 0.39 compared with 1.45 ± 0.31 mmol/L × h, P = 0.03) values were observed for LE compared with SE. The compositions of the CMRF-TAG FAs shifted toward those of the ingested palm stearin by 4 h but did not differ between SE and LE (P = 0.90). Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
CONCLUSIONS


Despite their identical compositions and colloidal properties, differences in lipid absorption were observed between SE and LE in healthy adult men. This is direct evidence that TAG physical state contributes to PPL, with the presence of solid fat having an attenuating influence.This trial was registered at clinicaltrials.gov as NCT03515590.",2020,"Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
","['SD age: 27.5\xa0±\xa05.7 y', 'healthy adult men', 'Ten percent palm stearin and 0.4% sorbitan monostearate emulsions', 'Fifteen healthy fasting adult men (mean\xa0±', 'Healthy Men']","['Emulsion Droplet Crystallinity', 'undercooled liquid oil']","['higher peak concentration', 'plasma TAG concentrations, particle size of the plasma chylomicron-rich fraction (CMRF), and fatty acid (FA) composition of the CMRF-TAG', 'postprandial changes in CMRF particle size', 'CMRF-TAG FAs', 'lipid physical state', 'nonesterified FAs', 'lipid absorption', 'Postprandial Plasma Triacylglycerol Responses', 'mean postprandial TAG change']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0041111', 'cui_str': 'glyceryl tristearate'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0074915', 'cui_str': 'sorbitan monostearate'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",15.0,0.362086,"Nor were there differences in postprandial changes in CMRF particle size (P = 0.79) or nonesterified FAs (P = 0.72) based on lipid physical state.
","[{'ForeName': 'Surangi H', 'Initials': 'SH', 'LastName': 'Thilakarathna', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Hamad', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cuncins', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz207']
1237,31894015,The Community Resiliency Model® to promote nurse well-being.,"BACKGROUND


Rising rates of secondary traumatic stress and burnout among nurses signal a crisis in healthcare. There is a lack of evidence regarding effective interventions to improve nurse well-being and resiliency.
PURPOSE


This study used a randomized controlled trial parallel design to test the effectiveness of a 3-hour Community Resiliency Model® (CRM) training, a novel set of sensory awareness techniques to improve emotional balance.
METHODS


Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented and were randomized into the CRM intervention or nutrition education control group to determine if the CRM group would demonstrate improvement in well-being and resiliency, secondary traumatic stress, burnout, and physical symptoms.
FINDINGS


Pre/post data were analyzed for 40 CRM and 37 nutrition group members. Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms. Participants reported using CRM techniques for self-stabilization during stressful work events.
DISCUSSION


CRM shows promise as a brief resiliency training for hospital-based nurses.",2020,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","['nurses signal a crisis in healthcare', 'Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented']","['CRM intervention or nutrition education control', 'CRM', '3-hour Community Resiliency Model® (CRM) training']","['well-being, resiliency, secondary traumatic stress, and physical symptoms']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",196.0,0.0288997,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Grabbe', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA. Electronic address: lgrabbe@emory.edu.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Baird', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}, {'ForeName': 'Patricia Ann', 'Initials': 'PA', 'LastName': 'Craven', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'San Fratello', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}]",Nursing outlook,['10.1016/j.outlook.2019.11.002']
1238,31859197,Comparison of intradermal mesotherapy with systemic therapy in the treatment of low back pain: A prospective randomized study.,"INTRODUCTION


Musculoskeletal pain such as low back pain (LBP) are routinely encountered in the ED and contribute to ED overcrowding. The aim of our study was to compare the efficiency of mesotherapy with systemic therapy in pain control in patients with lumbar disk herniation.
METHODS


We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with low back pain related to herniated lumbar disk. Mesotherapy was performed to one group, while intravenous dexketoprofen was administered to the control group. Changes in pain intensity at 15th minute, 30th minute, 60th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 h after treatment, and adverse effect of the treatment methods were compared between groups.
RESULTS


The decreases in pain intensity were statistically significantly higher in mesotherapy group for all time intervals. The need to use analgesics was statistically significantly three fold higher in the systemic therapy group. There was no statistically significant difference in having any adverse effect between study groups during one-week follow-up period.
CONCLUSIONS


Changes in medical practices, from the systemic administration of NSAIDs to the minimally invasive techniques such as mesotherapy with potent efficacy and minimal side effects, may enhance the ability of EDs to meet the waiting time targets and improve patient's satisfaction.",2020,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"['low back pain', 'patients with lumbar disk herniation', 'patients admitted to the emergency department with low back pain related to herniated lumbar disk']","['intradermal mesotherapy with systemic therapy', 'mesotherapy with systemic therapy', 'dexketoprofen', 'Mesotherapy']","['Visual Analogue Scale (VAS), need to use analgesic drug', 'pain intensity', 'adverse effect']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0708111,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingöl State Hospital, Bingöl, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.044']
1239,30790211,Reducing bedtime physiological arousal levels using immersive audio-visual respiratory bio-feedback: a pilot study in women with insomnia symptoms.,"Hyperarousal is a critical component of insomnia, particularly at bedtime when individuals are trying to fall asleep. The current study evaluated the effect of a novel, acute behavioral experimental manipulation (combined immersive audio-visual relaxation and biofeedback) in reducing bedtime physiological hyperarousal in women with insomnia symptoms. After a clinical/adaptation polysomnographic (PSG) night, sixteen women with insomnia symptoms had two random-order PSG nights: immersive audio-visual respiratory bio-feedback across the falling asleep period (manipulation night), and no pre-sleep arousal manipulation (control night). While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation. HR continued to be lower during sleep, and participants had fewer awakenings and sleep stage transitions on the manipulation night relative to the control night (p < 0.05). The manipulation did not affect sleep onset latency or other PSG parameters. Overall, this novel behavioral approach targeting the falling asleep process emphasizes the importance of pre-sleep hyperarousal as a potential target for improving sleep and nocturnal autonomic function during sleep in insomnia.",2019,"While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation.","['sixteen women with insomnia symptoms had two random-order PSG nights', 'women with insomnia symptoms']","['novel, acute behavioral experimental manipulation (combined immersive audio-visual relaxation and biofeedback', 'immersive audio-visual respiratory bio-feedback', 'immersive audio-visual respiratory bio-feedback across the falling asleep period (manipulation night), and no pre-sleep arousal manipulation (control night']","['bedtime physiological hyperarousal', 'awakenings and sleep stage transitions', 'immersive audio-visual respiratory bio-feedback, overall heart rate variability', 'heart rate (HR', 'bedtime physiological arousal levels']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16.0,0.0282431,"While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation.","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA. massimiliano.dezambotti@sri.com.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Sizintsev', 'Affiliation': 'Center for Vision Technologies, SRI International, Princeton, NJ, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Claudatos', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Giacinto', 'Initials': 'G', 'LastName': 'Barresi', 'Affiliation': 'Department of Advanced Robotics, Istituto Italiano di Tecnologia, Genoa, Italy.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Colrain', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00020-9']
1240,31483156,Heat therapy reduces sympathetic activity and improves cardiovascular risk profile in women who are obese with polycystic ovary syndrome.,"Polycystic ovary syndrome (PCOS) affects up to 15% of women and is associated with increased risk of obesity and cardiovascular disease. Repeated passive heat exposure [termed ""heat therapy"" (HT)] is a lifestyle intervention with the potential to reduce cardiovascular risk in obesity and PCOS. Women with obesity ( n  = 18) with PCOS [age 27 ± 4 yr, body mass index (BMI) 41.3 ± 4.7 kg/m 2 ] were matched for age and BMI, then assigned to HT ( n  = 9) or time control (CON;  n  = 9). HT subjects underwent 30 one-hour hot tub sessions over 8-10 wk, whereas CON subjects did not undergo HT. Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function were assessed at the start (Pre) and end (Post) of 8-10 wk. These measures included carotid and femoral artery wall thickness and flow-mediated dilation (FMD), measured both before and after 20 min of ischemia-20 min of reperfusion (I/R) stress. HT subjects exhibited reduced MSNA burst frequency (Pre: 20 ± 8 bursts/min, Post: 13 ± 5 bursts/min,  P  = 0.012), systolic (Pre: 124 ± 5 mmHg, Post: 114 ± 6 mmHg;  P  < 0.001) and diastolic blood pressure (Pre: 77 ± 6 mmHg, Post: 68 ± 3 mmHg;  P  < 0.001), C-reactive protein (Pre: 19.4 ± 13.7 nmol/L, Post: 15.2 ± 12.3 nmol/L;  P  = 0.018), total cholesterol (Pre: 5.4 ± 1.1 mmol/L, Post: 5.0 ± 0.8 mmol/L;  P  = 0.028), carotid wall thickness (Pre: 0.054 ± 0.005 cm, Post: 0.044 ± 0.005 cm;  P  = 0.010), and femoral wall thickness (Pre: 0.056 ± 0.009 cm, Post: 0.042 ± 0.005 cm;  P  = 0.003). FMD significantly improved in HT subjects over time following I/R (Pre: 5.6 ± 2.5%, Post: 9.5 ± 1.7%;  P  < 0.001). No parameters changed over time in CON, and BMI did not change in either group. These findings indicate that HT reduces sympathetic nerve activity, provides protection from I/R stress, and substantially improves cardiovascular risk profiles in women who are obese with PCOS.",2019,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","['obese women with PCOS', 'obese women with polycystic ovary syndrome', 'Eighteen obese women with PCOS (Age: 27±4y, body mass index']","[""Repeated passive heat exposure (termed 'heat therapy"", 'Heat therapy']","['sympathetic activity', 'time in CON, and BMI', 'Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function', 'cardiovascular risk profiles', 'femoral wall thickness', 'cardiovascular risk profile', 'diastolic blood pressure', 'FMD', 'carotid and femoral artery wall thickness and flow-mediated dilation (FMD', 'risk of obesity and cardiovascular disease', 'MSNA burst frequency', 'C-Reactive protein', 'total cholesterol', 'carotid wall thickness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239930', 'cui_str': 'Exposure to heat (event)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",18.0,0.0370644,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Francisco', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Samantha D', 'Initials': 'SD', 'LastName': 'Bryan', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Lindan N', 'Initials': 'LN', 'LastName': 'Comrada', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Larson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Vienna E', 'Initials': 'VE', 'LastName': 'Brunt', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00078.2019']
1241,31484666,Predictors of Recurrent Severe Hypoglycemia in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia During the HypoCOMPaSS Study.,"OBJECTIVE


The HypoCOMPaSS study was designed to test the hypothesis that successful avoidance of biochemical hypoglycemia without compromising overall glycemic control would restore sufficient hypoglycemia awareness to prevent recurrent severe hypoglycemia in the majority of participants with established type 1 diabetes. Before starting the study, we planned to investigate associations between baseline characteristics and recurrent severe hypoglycemia over 2 years' follow-up.
RESEARCH DESIGN AND METHODS


A total of 96 adults with type 1 diabetes and impaired awareness of hypoglycemia participated in a 24-week 2 × 2 factorial randomized controlled trial comparing insulin delivery and glucose monitoring modalities, with the goal of rigorous biochemical hypoglycemia avoidance. The analysis included 71 participants who had experienced severe hypoglycemia in the 12-month prestudy with confirmed absence (complete responder) or presence (incomplete responder) of severe hypoglycemia over 24 months' follow-up.
RESULTS


There were 43 (61%) complete responders and 28 (39%) incomplete responders experiencing mean ± SD 1.5 ± 1.0 severe hypoglycemia events/person-year. At 24 months, incomplete responders spent no more time with glucose ≤3 mmol/L (1.4 ± 2.1% vs. 3.0 ± 4.8% for complete responders;  P  = 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units/24 h;  P  = 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 ± 2.2 vs. 2.0 ± 1.9;  P  = 0.01). Baseline severe hypoglycemia rate (16.9 ± 16.3 vs. 6.4 ± 10.8 events/person-year;  P  = 0.002) and fear of hypoglycemia were higher in incomplete responders. Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%];  P  < 0.001) with a trend toward increased autonomic neuropathy.
CONCLUSIONS


Recurrent severe hypoglycemia was associated with higher preintervention severe hypoglycemia rate, fear of hypoglycemia, and concomitant neuropathy.",2020,Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%];  ,"['96 adults with type 1 diabetes and impaired awareness of hypoglycemia participated in a 24-week 2 × 2 factorial randomized controlled trial comparing', 'Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia', 'participants with established type 1 diabetes', ""71 participants who had experienced severe hypoglycemia in the 12-month prestudy with confirmed absence (complete responder) or presence (incomplete responder) of severe hypoglycemia over 24 months' follow-up""]",['insulin delivery and glucose monitoring modalities'],"['impairment of hypoglycemia awareness', 'Baseline severe hypoglycemia rate', 'fear of hypoglycemia', 'Peripheral neuropathy', 'autonomic neuropathy', 'incomplete responders spent no more time with glucose ≤3 mmol/L', 'preintervention severe hypoglycemia rate, fear of hypoglycemia, and concomitant neuropathy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy (disorder)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",71.0,0.0475418,Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%];  ,"[{'ForeName': 'Anneliese J S', 'Initials': 'AJS', 'LastName': 'Flatt', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Little', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Lalantha', 'Initials': 'L', 'LastName': 'Leelarathna', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Walkinshaw', 'Affiliation': 'School of Medicine and Biomedical Sciences, The University of Sheffield, Sheffield, U.K.'}, {'ForeName': 'Horng Kai', 'Initials': 'HK', 'LastName': 'Tan', 'Affiliation': 'Peninsula College of Medicine and Dentistry, Plymouth, U.K.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Bowes', 'Affiliation': 'Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lubina-Solomon', 'Affiliation': 'School of Medicine and Biomedical Sciences, The University of Sheffield, Sheffield, U.K.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holmes-Truscott', 'Affiliation': 'Newcastle Diabetes Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Chadwick', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'McDonald', 'Affiliation': 'Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, U.K.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Flanagan', 'Affiliation': 'Peninsula College of Medicine and Dentistry, Plymouth, U.K.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Brooks', 'Affiliation': 'Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'School of Medicine and Biomedical Sciences, The University of Sheffield, Sheffield, U.K.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'James A M', 'Initials': 'JAM', 'LastName': 'Shaw', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, U.K. jim.shaw@ncl.ac.uk.'}]",Diabetes care,['10.2337/dc19-0630']
1242,31437695,"Antidepressant and antisuicidal effects of ketamine on the functional connectivity of prefrontal cortex-related circuits in treatment-resistant depression: A double-blind, placebo-controlled, randomized, longitudinal resting fMRI study.","BACKGROUND


Increasing evidence suggests that infusion of a subanesthetic dose of ketamine exerts antidepressant and antisuicidal effects in patients with treatment-resistant depression (TRD).
AIMS


In this investigation, we used the resting functional connectivity magnetic resonance imaging (fcMRI) to determine the effects of ketamine on the functional connectivity (FC) of prefrontal cortex (PFC)-related circuits in patients with TRD.
METHODS


Forty-eight patients with TRD were recruited and randomly divided into three groups on the basis of ketamine infusion dose: 0.5 mg/kg (standard dose), 0.2 mg/kg (low dose), or normal saline (a placebo infusion). Resting functional MRI data and clinical data were recorded at the baseline and on the third day after ketamine infusion treatment.
RESULTS


The standard-dose group showed a reduction in the FC of the left dorsal anterior cingulate cortex (dACC) and right dorsolateral (dl)PFC with the other frontal regions. The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions. A negative correlation was observed between the reduction in suicidal ideation and the reduction in the FC between the left dACC and right ACC regions in the standard-dose group, whereas a positive correlation was observed between the reduction in suicidal ideation and the increase in the FC between the right dlPFC and left superior parietal region in the low-dose group.
CONCLUSIONS


Our results support the hypothesis that PFC-related circuit modulation is crucial to the antidepressant and antisuicidal effects of the ketamine infusion treatment.",2019,The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions.,"['treatment-resistant depression', 'Forty-eight patients with TRD', 'patients with treatment-resistant depression (TRD', 'patients with TRD']","['ketamine infusion dose: 0.5\u202fmg/kg (standard dose), 0.2\u202fmg/kg (low dose), or normal saline (a placebo', 'placebo', 'ketamine']","['functional connectivity (FC) of prefrontal cortex (PFC)-related circuits', 'FC of the left dorsal anterior cingulate cortex (dACC) and right dorsolateral (dl)PFC', 'Resting functional MRI data and clinical data', 'suicidal ideation']","[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",48.0,0.0367843,The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Philosophy of Mind and Cognition, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: peichitu@gmail.com.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Philosophy of Mind and Cognition, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, General Cheng Hsin Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.022']
1243,31472930,Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial.,"BACKGROUND


In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia.
METHODS


In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing.
FINDINGS


Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79-0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08-1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
INTERPRETATION


There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2019,"There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
","['late preterm pre-eclampsia (PHOENIX', '46 maternity units across England and Wales', '450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to', ""in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy"", 'Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited', 'women with late preterm pre-eclampsia']","['expectant management', 'planned delivery versus expectant management (usual care) with individual randomisation', 'expectant management (usual care', 'Planned early delivery or expectant management']","['incidence of the co-primary maternal outcome', 'serious adverse events', 'incidence of the co-primary perinatal outcome by intention to treat', 'maternal morbidity and severe hypertension', 'composite of maternal morbidity or recorded systolic blood pressure', 'composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence', 'neonatal morbidity']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2977407', 'cui_str': 'Dichorionic diamniotic twin pregnancy'}]","[{'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",450.0,0.260126,"There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
","[{'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. Electronic address: lucy.chappell@kcl.ac.uk.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brocklehurst', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, UK.'}, {'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Green', 'Affiliation': 'Action on Pre-eclampsia, Evesham, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Placzek', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Townend', 'Affiliation': 'National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""UCL EGA Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31963-4']
1244,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
1245,32439253,Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial.,"BACKGROUND


There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).
RESEARCH QUESTION


To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.
STUDY DESIGN AND METHODS


A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care).
RESULTS


Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI -4.1/+43.8)] and Chronic Respiratory Disease Questionnaire - Emotion score [0.4 points (0-0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0-15.4)] and Chronic Respiratory Disease Questionnaire - Emotion [0.5, (0.2-0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
CONCLUSIONS


The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function. CLINICALTRIALS.
GOV IDENTIFIER


NCT03247933.",2020,"Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
","['Ninety-four patients (46 IG, 48 CG', 'COPD patients', 'COPD Patients']","['maintenance pulmonary telerehabilitation (TelePR) programme', 'Telerehabilitation Programme', 'appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform']","['Short Form-36 mental component summary', 'Chronic Respiratory Disease Questionnaire - Emotion score', 'Acute exacerbations', '6-minute walk distance', '6-min walk distance', 'Chronic Respiratory Disease Questionnaire - Emotion']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184015', 'cui_str': 'Training equipment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",,0.135952,"Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
","[{'ForeName': 'Juan B', 'Initials': 'JB', 'LastName': 'Galdiz', 'Affiliation': 'Respiratory Department, Hospital Universitario Cruces, Osakidetza, Biocruces Bizkaia Health Research Institute, CibeRes, Barakaldo, Spain. Electronic address: med001901@hotmail.com.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Gómez', 'Affiliation': ""Unitat Rehabilitació Cardio-Respiratoria, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Respiratory Department, Hospital del Mar, CibeRes, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Guell', 'Affiliation': 'Respiratory Department, Hospital de la Santa Creu i San Pau, CibeRes, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cebollero', 'Affiliation': 'Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Hueto', 'Affiliation': 'Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cejudo', 'Affiliation': 'Instituto de Biomedicina de Sevilla, Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocío, Sevilla, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortega', 'Affiliation': 'Instituto de Biomedicina de Sevilla, Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocio, CibeRes, Sevilla, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Sayago', 'Affiliation': 'Respiratory Department, Clínica Asunción, Tolosa, Gipuzkoa, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Chic', 'Affiliation': 'Internal Medicine Department (Respiratory Unit), Hospital de Mendaro, Osakidetza, Mendaro, Gipuzkoa, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Iscar', 'Affiliation': 'Respiratory Department, Hospital General de Asturias, Oviedo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Amado', 'Affiliation': 'Respiratory Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Rodríguez Trigo', 'Affiliation': 'Respiratory Department, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Borja G', 'Initials': 'BG', 'LastName': 'Cosio', 'Affiliation': 'Respiratory Department, Hospital Universitary Son Espases, Palma de Mallorca, CibeRes, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Bustamante', 'Affiliation': 'Respiratory Department, Hospital Universitario Basurto, Bilbao, Spain.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Pijoan', 'Affiliation': 'Clinical Epidemiology Unit, Hospital Universitario de Cruces, Biocruces Bizkaia, Health Research Institute, Bilbao, Spain.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.03.034']
1246,31740726,"Neuromodulation of the prefrontal cortex facilitates diet-induced weight loss in midlife women: a randomized, proof-of-concept clinical trial.","BACKGROUND


High body mass index (BMI) is associated with neurocognitive impairments that contribute to overeating and interfere with weight loss efforts. Overweight and obesity at midlife can accelerate neurodegenerative changes and increase the risk of late-life dementia. Noninvasive neuromodulation represents a novel, affordable and scalable approach to improve neurocognitive function in this context. The purpose of this proof-of-concept study was to examine whether transcranial direct current stimulation (tDCS) aimed at enhancing prefrontal cortex activity could enhance weight loss, in combination with a hypocaloric diet, and study underlying mechanisms.
METHODS


Overall, 38 women with BMI 25-35 kg/m 2  underwent a 4 week randomized, double-blinded, sham-controlled, and parallel-design intervention, during which they received eight sessions of tDCS (n = 18 sham, n = 20 active) in combination with a diet (caloric goal of 20 kcal/kg/day). We evaluated longitudinal changes in body weight, appetite and food craving. In addition, we examined the contribution of cognitive-executive processes via food-modified computerized tasks.
RESULTS


We found that the active group had more reduction in body weight than the sham group throughout the study (p = 0.020) and significant weekly weight loss. At 4 weeks, the active group lost 2.32% of initial body weight (sham: 1.29%). Components of subjective appetite and food craving showed a trend toward more reduction in the active group. These changes were paralleled by significant improvements in task performance in the active group, particularly in a dual task that required inhibitory control and working memory (p = 0.007-0.031). Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003). No significant adverse effects were observed.
CONCLUSIONS


Our results provide proof-of-concept validation of prefrontal-targeted tDCS, combined with a diet, in midlife women with excess body weight, paving the way for larger studies evaluating clinical efficacy and long-term effects of this intervention.",2020,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","['38 women with BMI 25-35\u2009kg/m 2', 'midlife women with excess body weight', 'midlife women']","['transcranial direct current stimulation (tDCS', 'tDCS (n\u2009=\u200918 sham, n\u2009=\u200920 active) in combination with a diet']","['neurocognitive function', 'body weight', 'body weight, appetite and food craving', 'weight loss', 'task performance', 'inhibitory control and working memory', 'subjective appetite and food craving', 'adverse effects', 'lack of control overeating']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]",38.0,0.115754,"Improvement in inhibitory control performance predicted reduction in lack of control overeating, explaining 43.5% of its variance at the end of the study (p = 0.003).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Villa', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Santiago Milla', 'Initials': 'SM', 'LastName': 'Navarro', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Andresa Evelem de', 'Initials': 'AE', 'LastName': 'Melo Aroeira', 'Affiliation': 'Department of Systems Biology. School of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amo Usanos', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Martínez Cancio', 'Affiliation': 'Primary Care Unit, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cuesta Villa', 'Affiliation': 'Clinical Neurophysiology, Centro Médico Complutense. Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Section on Genetics and Epidemiology, Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. migalonsoalonso@alumni.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0486-x']
1247,32440730,Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial.,"PURPOSE


Compared to a healthy population, the gut microbiota in type 2 diabetes presents with several unfavourable features that may impair glucose regulation. The aim of this study was to evaluate the prebiotic effect of inulin-type fructans on the faecal microbiota and short-chain fatty acids (SCFA) in patients with type 2 diabetes.
METHODS


The study was a placebo controlled crossover study, where 25 patients (15 men) aged 41-71 years consumed 16 g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g placebo (maltodextrin) for 6 weeks in randomised order. A 4-week washout separated the 6 weeks treatments. The faecal microbiota was analysed by high-throughput 16S rRNA amplicon sequencing and SCFA in faeces were analysed using vacuum distillation followed by gas chromatography.
RESULTS


Treatment with inulin-type fructans induced moderate changes in the faecal microbiota composition (1.5%, p = 0.045). A bifidogenic effect was most prominent, with highest positive effect on operational taxonomic units (OTUs) of Bifidobacterium adolescentis, followed by OTUs of Bacteroides. Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo. The prebiotic fibre had no effects on the concentration of butyric acid or on the overall microbial diversity.
CONCLUSION


Six weeks supplementation with inulin-type fructans had a significant bifidogenic effect and induced increased concentrations of faecal SCFA, without changing faecal microbial diversity. Our findings suggest a moderate potential of inulin-type fructans to improve gut microbiota composition and to increase microbial fermentation in type 2 diabetes.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT02569684).",2020,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","['type 2 diabetes', '25 patients (15 men) aged 41-71\xa0years consumed 16\xa0g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g', 'patients with type 2 diabetes']","['placebo (maltodextrin', 'inulin-type fructans', 'placebo']","['faecal concentrations of total SCFA, acetic acid and propionic acid', 'faecal microbiota and short-chain fatty acids (SCFA', 'faecal microbiota and short-chain fatty acids', 'microbial fermentation', 'faecal microbiota', 'faecal microbiota composition', 'concentrations of faecal SCFA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0995287,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02282-5']
1248,31437703,Normalization of EEG in depression after antidepressant treatment with sertraline? A preliminary report.,"BACKGROUND


MDD patients with abnormal EEG patterns seem more likely to be non-responsive to the antidepressants escitalopram and venlafaxine, but not sertraline, than patients without EEG abnormalities. This finding suggests that patients with both MDD and abnormal EEGs may differentially respond to antidepressant treatment. In the current study, we investigated whether depressed patients with an abnormal EEG show a normalization of the EEG related to antidepressant treatment and response and whether such effect is drug specific, and whether having had early life stress (ELS) increases the chance of abnormal activity.
METHODS


Baseline and week 8 EEGs and depression symptoms were extracted from a large multicenter study (iSPOT-D, n = 1008) where depressed patients were randomized to escitalopram, sertraline, or venlafaxine-XR treatment. We calculated Odds Ratios of EEG normalization and depression response in patients with an abnormal EEG at baseline, comparing sertraline versus other antidepressants.
RESULTS


Fifty seven patients with abnormal EEGs were included. EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280). However, patients with a normalized EEG taking sertraline were 5.2 times more likely to respond than subjects taking other antidepressants (p = .019). ELS was not significantly related to abnormal activity.
LIMITATIONS


Neurophysiological recordings were limited in time (two times 2-minute EEGs) and statistical power (n = 57 abnormal EEGs).
CONCLUSIONS


Response rates in patients with normalized EEG taking sertraline were significantly larger than in subjects treated with escitalopram/venlafaxine. This adds to personalized medicine and suggests a possible drug repurposing for sertraline.",2019,"EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280).","['MDD patients with abnormal EEG patterns', 'Fifty', 'Baseline and week 8 EEGs and depression symptoms were extracted from a large multicenter study (iSPOT-D, n\u202f=\u202f1008) where depressed patients', 'seven patients with abnormal EEGs']","['sertraline', 'venlafaxine', 'escitalopram/venlafaxine', 'escitalopram, sertraline, or venlafaxine-XR treatment']","['Odds Ratios of EEG normalization and depression response', 'abnormal activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151611', 'cui_str': 'EEG abnormal'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",57.0,0.0305369,"EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Synaeda Psycho Medisch Centrum, Leeuwarden, the Netherlands; Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Clinical Neurophysiology, Faculty Science and Technology, University of Twente, Enschede, the Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Boutros', 'Affiliation': ""Saint Luke's Marion Bloch Neuroscience Institute, Kansas City, MO, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fallahpour', 'Affiliation': 'Icahn School of Medicine, Mount Sinai, New York, USA; Brain Resource Center, New York, USA.'}, {'ForeName': 'M J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Faculty Science and Technology, University of Twente, Enschede, the Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.016']
1249,32086187,Percolating ideas: The effects of caffeine on creative thinking and problem solving.,"Caffeine is the most widely consumed psychotropic drug in the world, with numerous studies documenting the effects of caffeine on people's alertness, vigilance, mood, concentration, and attentional focus. The effects of caffeine on creative thinking, however, remain unknown. In a randomized placebo-controlled between-subject double-blind design the present study investigated the effect of moderate caffeine consumption on creative problem solving (i.e., convergent thinking) and creative idea generation (i.e., divergent thinking). We found that participants who consumed 200 mg of caffeine (approximately one 12 oz cup of coffee, n = 44), compared to those in the placebo condition (n = 44), showed significantly enhanced problem-solving abilities. Caffeine had no significant effects on creative generation or on working memory. The effects remained after controlling for participants' caffeine expectancies, whether they believed they consumed caffeine or a placebo, and changes in mood. Possible mechanisms and future directions are discussed.",2020,Caffeine had no significant effects on creative generation or on working memory.,[],"['Caffeine', 'caffeine', 'placebo', 'moderate caffeine consumption']","['enhanced problem-solving abilities', 'creative generation or on working memory']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.21646,Caffeine had no significant effects on creative generation or on working memory.,"[{'ForeName': 'Darya L', 'Initials': 'DL', 'LastName': 'Zabelina', 'Affiliation': 'University of Arkansas, 480 Campus Drive, Fayetteville, AR 72701, USA. Electronic address: dlzabeli@uark.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Silvia', 'Affiliation': 'University of North Carolina at Greensboro, Department of Psychology, P.O. Box 26170, Greensboro, NC 27402, USA.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102899']
1250,31470444,Effects of Edoxaban on the Cellular and Protein Phase of Coagulation in Patients with Coronary Artery Disease on Dual Antiplatelet Therapy with Aspirin and Clopidogrel: Results of the EDOX-APT Study.,"In patients requiring dual antiplatelet therapy (DAPT) who also have an indication to be treated with oral anticoagulant (OAC) drugs, aspirin withdrawal reduces the risk of bleeding. There is limited data on the pharmacodynamic effects associated with adding a nonvitamin K antagonist OAC on a background of aspirin and a P2Y 12  inhibitor as well as dropping aspirin. Seventy-five patients on DAPT (aspirin plus clopidogrel) were randomized to DAPT plus high-dose edoxaban (60 mg once daily, Group A), DAPT plus low-dose edoxaban (30 mg once daily, Group B), or DAPT only (Group C) for 10 ± 2 days (Phase I). Afterwards, Groups A and B interrupted aspirin and maintained clopidogrel plus edoxaban for 10 ± 2 days, while patients in Group C maintained DAPT (Phase II). Platelet aggregation and clot kinetics were assessed at baseline, end of Phase I, and end of Phase II using thrombelastography (TEG), light transmittance aggregometry (LTA), VerifyNow P2Y 12 , and serum thromboxane-B 2 . The primary endpoint was the comparison of maximum amplitude (MA) measured by TEG, a measure of clot strength, between patients on DAPT plus high-dose edoxaban and patients on DAPT only. Edoxaban prolonged in a dose-dependent manner speed of thrombin generation (TEG R; Group A: 7.7 [6.8-8.7] vs. Group B: 7.4 [6.4-8.5] vs. Group C: 6.3 [5.7-7.0];  p  = 0.05) but did not affect other markers of clot kinetics, including TEG MA (Group A: 63 [61-64] vs. Group B: 65 [63-67] vs. Group C: 64 [63-65];  p  = 0.10). After aspirin discontinuation, platelet reactivity assessed by LTA using thrombin receptor activating peptide as agonist increased to a greater extent with low-dose edoxaban. Stopping aspirin did not affect markers of P2Y 12  reactivity and had no or marginal effects on clot kinetics, but increased markers sensitive to cyclooxygenase-1 blockade.",2020,Edoxaban prolonged in a dose-dependent manner speed of thrombin generation (TEG R;,"['patients requiring dual antiplatelet therapy (DAPT) who also have an indication to be treated with oral anticoagulant (OAC) drugs', 'Seventy-five patients on', 'Patients with Coronary Artery Disease on Dual Antiplatelet Therapy with']","['TEG MA', 'DAPT (aspirin plus clopidogrel', 'aspirin', 'edoxaban', 'aspirin withdrawal', 'Edoxaban', 'Aspirin and Clopidogrel', 'DAPT plus high-dose edoxaban', 'DAPT plus low-dose edoxaban', 'aspirin and maintained clopidogrel plus edoxaban']","['clot kinetics', 'manner speed of thrombin generation (TEG R', 'platelet reactivity', 'Platelet aggregation and clot kinetics', 'risk of bleeding', 'comparison of maximum amplitude (MA) measured by TEG, a measure of clot strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",75.0,0.0318158,Edoxaban prolonged in a dose-dependent manner speed of thrombin generation (TEG R;,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Garcia', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rivas Rios', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Malhar', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Kureti', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Nagaraju', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Jae Youn', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kairouz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Yaranov', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States.'}]",Thrombosis and haemostasis,['10.1055/s-0039-1695772']
1251,32439432,"Low-dose capsaicin (0.01 mM) nasal spray is equally effective as the current standard treatment for idiopathic rhinitis: A randomized, double-blind, placebo-controlled trial.",,2020,,['idiopathic rhinitis'],"['Low-dose capsaicin', 'placebo']",[],"[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.306706,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Van Gerven', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, University Hospitals Leuven, Leuven, Belgium; Allergy and Clinical Immunology Research Unit, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium. Electronic address: laura.vangerven@uzleuven.be.'}, {'ForeName': 'Brecht', 'Initials': 'B', 'LastName': 'Steelant', 'Affiliation': 'Allergy and Clinical Immunology Research Unit, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Cools', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Wout', 'Initials': 'W', 'LastName': 'Backaert', 'Affiliation': 'Allergy and Clinical Immunology Research Unit, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Hoon', 'Affiliation': 'Center for Clinical Pharmacology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ampe', 'Affiliation': 'Center for Clinical Pharmacology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Talavera', 'Affiliation': 'Laboratory for Ion Channel Research and TRP Research Platform Leuven (TRPLe), Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, University Hospitals Leuven, Leuven, Belgium; Allergy and Clinical Immunology Research Unit, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium; Department of Otorhinolaryngology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands; Laboratory of Upper Airways Research, Department of Otorhinolaryngology, University of Ghent, Ghent, Belgium.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.04.054']
1252,31296508,Efficacy of mindfulness-based intervention ('mindfulness-based joyful sleep') in young and middle-aged individuals with insomnia using a biomarker of inflammatory responses: a prospective protocol of a randomised controlled trial in China.,"INTRODUCTION


Insomnia is a prevalent and significant public health concern. Insomnia can lead to increased inflammatory markers associated with chronic diseases such as cardiovascular disease, diabetes and cancer. Studies suggest that mindfulness-based interventions (MBIs) are more easily delivered within the community than cognitive behavioural therapy for insomnia (CBT-I) which was recommended as the preferred non-pharmacological treatment by the American Academy of Sleep Medicine, are effective in insomnia treatment and can reduce inflammatory markers level in older individuals with insomnia. This study aims to compare the effectiveness of an MBI to CBT-I in young and middle-aged individuals with insomnia disorder and explore its effect on nuclear factor kappa B (NF-κB), a transcription factor that controls the expression of genes involved in inflammation.
METHODS AND ANALYSIS


This report describes a protocol for a randomised controlled trial. Seventy eligible participants will be assigned to mindfulness-based joyful sleep or CBT-I for 2-hour sessions weekly for 8 weeks. The primary outcome is sleep quality assessed by the Pittsburgh Sleep Quality Index, severity of insomnia symptoms assessed by the Insomnia Severity Index and sleep parameters recorded using sleep diary and polysomnography. Secondary outcomes include perceived stress, anxiety and depression. The exploratory outcome is serum level of NF-κB. Outcomes will be evaluated at baseline, the end of the ntervention period and at a 3 month follow-up. Data will be analysed using general linear models, specifically analysis of covariance and analysis of variance will be used.
ETHICS AND DISSEMINATION


Full ethical approval for this study has been obtained from the Ethics Committee of the Third Xiangya Hospital, Central South University, Changsha, China (2018-S236). If Mindfulness-Based Joyful Sleep is proven effective, its dissemination will help bridge the gap between the unmet need and the demand for insomnia interventions in China.
TRIAL REGISTRATION NUMBER


NCT03268629; Pre-results.",2019,"Studies suggest that mindfulness-based interventions (MBIs) are more easily delivered within the community than cognitive behavioural therapy for insomnia (CBT-I) which was recommended as the preferred non-pharmacological treatment by the American Academy of Sleep Medicine, are effective in insomnia treatment and can reduce inflammatory markers level in older individuals with insomnia.","['young and middle-aged individuals with insomnia disorder', 'young and middle-aged individuals with insomnia using a biomarker of inflammatory responses', 'older individuals with insomnia', 'Seventy eligible participants']","['MBI to CBT-I', 'mindfulness-based interventions (MBIs', ""mindfulness-based intervention ('mindfulness-based joyful sleep""]","['serum level of NF-κB. Outcomes', 'perceived stress, anxiety and depression', 'sleep quality assessed by the Pittsburgh Sleep Quality Index, severity of insomnia symptoms assessed by the Insomnia Severity Index and sleep parameters recorded using sleep diary and polysomnography']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]",70.0,0.0725152,"Studies suggest that mindfulness-based interventions (MBIs) are more easily delivered within the community than cognitive behavioural therapy for insomnia (CBT-I) which was recommended as the preferred non-pharmacological treatment by the American Academy of Sleep Medicine, are effective in insomnia treatment and can reduce inflammatory markers level in older individuals with insomnia.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Psychosomatic Health Institute, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Peihuan', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry and Mental Health Institute, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",BMJ open,['10.1136/bmjopen-2018-027061']
1253,31437289,"Vietnamese American Dementia Caregivers' Perceptions and Experiences of a Culturally Tailored, Evidence-Based Program to Reduce Stress and Depression.","Vietnamese American dementia caregivers are at increased risk for adverse mental health compared to the general U.S. population given their sociodemographic and immigration experiences, yet programs that address their needs are lacking. The current article describes Vietnamese American dementia caregivers' perceptions and experiences of a culturally tailored, evidence-based intervention to reduce stress and depression. A convenience sample of caregivers was recruited from the San Francisco Bay area and randomly assigned to intervention (""Our Family Journey""; OFJ) (n = 30) or control (written dementia caregiving information) (n = 30) groups. All intervention and 76.7% of control caregivers reported that the OFJ or educational materials, respectively, were very/somewhat helpful. Three or more skills were refined/learned by 96.7% of OFJ and 36.6% of control participants. Qualitative findings indicated that the intervention had positive effects on well-being and taught new caregiving skills. This first U.S. study to address the mental health needs of Vietnamese American dementia caregivers shows positive perceptions/experiences and demonstrates a model to address a significant need in the community. [Journal of Gerontological Nursing, 45(9), 39-50.].",2019,Three or more skills were refined/learned by 96.7% of OFJ and 36.6% of control participants.,"['Vietnamese American Dementia Caregivers', 'A convenience sample of caregivers was recruited from the San Francisco Bay area and randomly assigned to', 'Vietnamese American dementia caregivers']","['OFJ', 'intervention (""Our Family Journey""; OFJ', 'control (written dementia caregiving information']",[],"[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]",[],,0.0277278,Three or more skills were refined/learned by 96.7% of OFJ and 36.6% of control participants.,"[{'ForeName': 'Van M', 'Initials': 'VM', 'LastName': 'Ta Park', 'Affiliation': ''}, {'ForeName': 'Vy', 'Initials': 'V', 'LastName': 'Ton', 'Affiliation': ''}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Yeo', 'Affiliation': ''}, {'ForeName': 'Quyen Q', 'Initials': 'QQ', 'LastName': 'Tiet', 'Affiliation': ''}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Vuong', 'Affiliation': ''}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Gallagher-Thompson', 'Affiliation': ''}]",Journal of gerontological nursing,['10.3928/00989134-20190813-05']
1254,31446994,"Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies.","OBJECTIVES


Most lung cancer diagnoses occur in elderly patients, who are underrepresented in clinical trials. We present a pooled analysis of safety and efficacy in elderly patients (≥75 years) who received pembrolizumab (a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors.
METHODS


The pooled analysis included patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors from the KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894) studies. In KEYNOTE-010, patients were randomized to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and KEYNOTE-042, patients were randomized to first-line pembrolizumab 200 mg Q3W or platinum-based chemotherapy. Overall survival (OS) was estimated by the Kaplan-Meier method, and safety data were summarized in elderly patients (≥75 years).
RESULTS


The analysis included 264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS ≥ 50%. Pembrolizumab improved OS among elderly patients with PD-L1 TPS ≥ 1% (hazard ratio [HR], 0.76 [95% CI, 0.56-1.02]) and PD-L1 TPS ≥ 50% (HR, 0.40 [95% CI, 0.25-0.64]). Pembrolizumab as first-line therapy also improved OS among elderly patients with PD-L1 TPS ≥ 50% (from KEYNOTE-024 and KEYNOTE-042) compared with chemotherapy (HR, 0.41 [95% CI, 0.23‒0.73]). Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy. Immune-mediated AEs and infusion reactions were more common with pembrolizumab versus chemotherapy (overall, 24.8% vs 6.7%; grade 3‒4: 9.4% vs 0%; no grade 5 events).
CONCLUSIONS


In this pooled analysis of elderly patients with advanced NSCLC with PD-L1‒positive tumors, pembrolizumab improved OS versus chemotherapy, with a more favorable safety profile. Outcomes with pembrolizumab in patients ≥75 years were comparable to those in the overall populations in the individual studies.",2019,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","['a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors', 'elderly patients (≥75 years) who received', '264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS\u202f≥\u202f50', 'elderly patients with advanced NSCLC with PD-L1‒positive tumors', 'patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors', 'elderly patients (≥75 years', 'elderly patients', 'elderly patients with PD-L1-positive advanced non-small-cell lung cancer', 'patients ≥75 years']","['pembrolizumab versus chemotherapy', 'Pembrolizumab', 'pembrolizumab', 'pembrolizumab improved OS versus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab 200\u2009mg Q3W or platinum-based chemotherapy', 'pembrolizumab 2 or 10\u2009mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy']","['Safety and efficacy', 'Immune-mediated AEs and infusion reactions', 'Overall survival (OS', 'safety and efficacy']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",264.0,0.245098,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nosaki', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Minami-ku, Fukuoka-shi, Fukuoka 811-1395, Japan. Electronic address: knosaki@east.ncc.go.jp.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan. Electronic address: hideosaka@me.com.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: yhosomi@cick.jp.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'The Netherlands Cancer Institute, Postbus 90203, 1006 BE Amsterdam, the Netherlands. Electronic address: p.baas@nki.nl.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo, SP 01246-000, Brazil. Electronic address: gilberto.castro@usp.br.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangdong, 106 Zhongshan 2nd Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng 510080, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Baltimore, 21287 MD, USA. Electronic address: brahmju@jhmi.edu.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, P. Vall d'Hebron, 119-129, 08035 and IOB Quiron, Barcelona, Spain. Electronic address: efelip@vhio.net.""}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: takeshi.sawada@merck.com.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Noguchi', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: kazuo.noguchi@merck.com.'}, {'ForeName': 'Shi Rong', 'Initials': 'SR', 'LastName': 'Han', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: shi.rong.han@merck.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: bilal.piperdi@merck.com.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kush', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: debra_kush@merck.com.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Ave, Miami, FL 33136, USA. Electronic address: glopes.md@gmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.07.004']
1255,31444589,A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma.,"Locally advanced or metastatic urothelial cancer is an aggressive form of cancer with high recurrence rates and low survival. Nectin-4 is a cell adhesion molecule commonly expressed in several tumors, including high expression in urothelial cancer. Enfortumab vedotin is an antibody-drug conjugate composed of an anti-Nectin-4 humanized monoclonal antibody linked to the microtubule disrupting agent, monomethyl auristatin E. In this phase I study (NCT03070990), Japanese patients with locally advanced/metastatic urothelial cancer treated with prior chemotherapy, or ineligible for cisplatin, were randomized 1:1 to receive 1.0 mg/kg (Arm A) or 1.25 mg/kg (Arm B) enfortumab vedotin on Days 1, 8, and 15 of each 28-day cycle. Assessing the pharmacokinetic and safety/tolerability profiles of enfortumab vedotin were primary objectives; investigator-assessed antitumor activity (RECIST v1.1) was a secondary objective. Seventeen patients (n = 9, Arm A; n = 8, Arm B) received treatment. Pharmacokinetic data suggest a dose-dependent increase in enfortumab vedotin maximum concentration and area under the concentration-time curve at Day 7. Enfortumab vedotin was well tolerated across both doses. Dysgeusia and alopecia (n = 9 each) were the most common treatment-related adverse events. Regardless of attribution, grade ≥ 3 adverse events occurring in ≥2 patients were anemia and hypertension (n = 2 each). One patient achieved a confirmed complete response (Arm A) and five achieved confirmed partial responses (n = 3, Arm A; n = 2, Arm B). Objective response and disease control rates were 35.3% and 76.5%, respectively. In Japanese patients with locally advanced/metastatic urothelial cancer, enfortumab vedotin is well tolerated with preliminary antitumor activity and a pharmacokinetic profile consistent with prior reports.",2020,Dysgeusia and alopecia (n = 9 each) were the most common treatment-related adverse events.,"['Japanese patients with locally advanced or metastatic urothelial carcinoma', 'Japanese patients with locally advanced/metastatic urothelial cancer', 'Locally advanced or metastatic urothelial cancer', 'Japanese patients with locally advanced/metastatic urothelial cancer treated with prior chemotherapy, or ineligible for']","['enfortumab vedotin', 'cisplatin']","['Dysgeusia and alopecia', 'enfortumab vedotin maximum concentration and area under the concentration-time curve', 'Objective response and disease control rates']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0405392,Dysgeusia and alopecia (n = 9 each) were the most common treatment-related adverse events.,"[{'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. s.takahashi-chemotherapy@jfcr.or.jp.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takamoto', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Yamaguchi', 'Affiliation': 'Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Melhem-Bertrandt', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA.'}, {'ForeName': 'Elaina M', 'Initials': 'EM', 'LastName': 'Gartner', 'Affiliation': 'Seattle Genetics, Seattle, WA, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Rio', 'Initials': 'R', 'LastName': 'Akazawa', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kadokura', 'Affiliation': 'Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tanikawa', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}]",Investigational new drugs,['10.1007/s10637-019-00844-x']
1256,31268469,Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial.,"Importance


Epicardial and pericardial adipose tissues are emerging as important risk factors for cardiovascular disease, and there is a growing interest in discovering strategies to reduce the accumulation of fat in these depots.
Objective


To investigate whether a 12-week endurance or resistance training intervention regulates epicardial and pericardial adipose tissue mass.
Design, Setting, and Participants


Secondary analysis of a randomized, assessor-blinded clinical trial initiated on August 2016 and completed April 2018. This single-center, community-based study included 50 physically inactive participants with abdominal obesity.
Interventions


Participants were randomized to a supervised high-intensity interval endurance training (3 times a week for 45 minutes), resistance training (3 times a week for 45 minutes), or no exercise (control group).
Main Outcomes and Measures


Change in epicardial and pericardial adipose tissue mass assessed by magnetic resonance imaging, based on a prespecified secondary analysis plan including 3 of 5 parallel groups.
Results


Of 50 participants (mean [SD] age, 41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study. Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively). While there was a nonsignificant reduction in pericardial adipose tissue mass after endurance training (11% [95% CI, -5% to 27%]; P = .17), resistance training significantly reduced pericardial adipose tissue mass by 31% (95% CI, 16%-47%; P < .001) when compared with the no exercise control group. Compared with the no exercise control group, there was an increase in left ventricular mass by endurance (20 g [95% CI, 11%-30%]; P < .001) and resistance training (18 g [95% CI, 8%-28%]; P < .001). Other cardiometabolic outcomes remained unchanged after the 12-week trial period.
Conclusions and Relevance


In individuals with abdominal obesity, both endurance and resistance training reduced epicardial adipose tissue mass, while only resistance training reduced pericardial adipose tissue mass. These data highlight the potential preventive importance of different exercise modalities as means to reduce cardiac fat in individuals with abdominal obesity.
Trial Registration


ClinicalTrials.gov identifier: NCT02901496.",2019,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","['individuals with abdominal obesity', 'Cardiac Adipose Tissues', '50 participants (mean [SD] age', '50 physically inactive participants with abdominal obesity', '41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study']","['supervised high-intensity interval endurance training', 'endurance or resistance training intervention', 'Endurance training and resistance training', 'Aerobic and Resistance Exercise', 'resistance training (3\u2009times a week for\u200945 minutes), or no exercise (control group']","['epicardial and pericardial adipose tissue mass', 'pericardial adipose tissue mass', 'epicardial adipose tissue mass', 'left ventricular mass by endurance', 'resistance training']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",50.0,0.183365,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","[{'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dorph', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Monica Korsager', 'Initials': 'MK', 'LastName': 'Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natja', 'Initials': 'N', 'LastName': 'Launbo', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabrina Ravn', 'Initials': 'SR', 'LastName': 'Fagerlind', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sidsel Kofoed', 'Initials': 'SK', 'LastName': 'Seide', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Nymand', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ball', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicole Buchner', 'Initials': 'NB', 'LastName': 'Vinum', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla Nørfelt', 'Initials': 'CN', 'LastName': 'Dahl', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Henneberg', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael Ploug', 'Initials': 'MP', 'LastName': 'Boesen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Capital Region of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2074']
1257,32017005,"The safety profile of probiotic VSL#3®. A meta-analysis of safety data from double-blind, randomized, placebo-controlled clinical trials.","OBJECTIVE


A high-concentration of a multi-strain probiotic mixture, VSL#3® is widely used 'whenever it is useful to promote the balance of intestinal flora'. As a food supplement, VSL#3® has been so far scarcely investigated on the aspect of safety. To fill this gap, in this paper, we analyzed the adverse events (AEs) recorded during the conduct of three (3) double-blind, randomized, placebo-controlled trials carried out to explore the efficacy of VSL#3® in various clinical settings. Data from a large open-label observational trial were also considered.
MATERIALS AND METHODS


All trials included in the analysis were carried out according to good clinical practice (GCP) rules. AEs were classified by System Organ Class (SOC), Preferred Term (PT) and frequency. Differences vs. placebo control were considered as statistically significant if the p-value was < 0.05.
RESULTS


A total of 120 patients were analyzed, 70 patients being included in the randomized controlled trials. In this population, 45 patients had at least one AE, 20 (64.5%) in the placebo group and 25 (64.1%) in the VSL#3® group. 29 patients had at least one related AE, 14 (45.2%) and 15 (38.5%) in the two treatment groups, respectively. Only one AE was assessed as serious, i.e., Foetal malformation, which occurred in the placebo group and was considered unrelated. No significant difference was found between VSL#3® and placebo for any of the SOC considered, with the exception of Injury, poisoning and procedural complications, which was in favor of VSL#3®.
CONCLUSIONS


Based on GCP-quality data from clinical trials, we conclude that VSL#3® is a safe and well-tolerated agent.",2020,"No significant difference was found between VSL#3® and placebo for any of the SOC considered, with the exception of Injury, poisoning and procedural complications, which was in favor of VSL#3®.
","['A total of 120 patients were analyzed, 70 patients being included in the randomized controlled trials']","['placebo', 'VSL#3®', 'probiotic VSL#3®']",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],120.0,0.634677,"No significant difference was found between VSL#3® and placebo for any of the SOC considered, with the exception of Injury, poisoning and procedural complications, which was in favor of VSL#3®.
","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Panetta', 'Affiliation': ""L'altrastatistica S.r.l., for GB Pharma Services & Consulting S.r.l, Rome, Italy. pierluigi.navarra@unicatt.it.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacchieri', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Papetti', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De Stefani', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Navarra', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202001_20082']
1258,31335458,A Comparison of Electronic and Paper Versions of the Montreal Cognitive Assessment.,"OBJECTIVE


The objective of this study was to investigate older adults' performance on the paper and electronic Montreal Cognitive Assessment (eMoCA).
DESIGN


Repeated measures and correlational design.
PARTICIPANTS


A convenience sample of 40 adults over 65 years of age living in the community.
INTERVENTIONS


Participants completed the eMoCA and paper Montreal Cognitive Assessment (MoCA) in a randomized order during 1 session. Participants reported their touchscreen experience and comfort and indicated their modality preferences.
MAIN OUTCOME MEASURES


The primary outcome measures were paper MoCA and eMoCA total and subscale scores. Secondary outcome measures included participants' reported touchscreen experience and comfort, as well as post-administration preferences.
RESULTS


A moderate statistically significant correlation was found between eMoCA and paper MoCA performance across all participants. Analysis comparing first administration modality only (eMoCA vs. paper MoCA) found no statistically significant difference in total scores; however, there was a statistically significant difference for the visuospatial/executive subscale, which required physical interaction with paper or the tablet. For this subscale, participants scored lower on the eMoCA versus paper MoCA. There was a statistically significant correlation between experience with touchscreen devices and performance on the eMoCA, but not between modality preference and performance.
CONCLUSION


Modality of administration can affect performance on cognitive assessments. Clinicians should consider individuals' level of touchscreen experience before selecting administration modality.",2019,"There was a statistically significant correlation between experience with touchscreen devices and performance on the eMoCA, but not between modality preference and performance.
","['older adults', 'A convenience sample of 40 adults over 65 years of age living in the community']","['electronic Montreal Cognitive Assessment (eMoCA', 'eMoCA and paper Montreal Cognitive Assessment (MoCA']","['visuospatial/executive subscale', 'eMoCA and paper MoCA performance', 'paper MoCA and eMoCA total and subscale scores', 'touchscreen experience and comfort, as well as post-administration preferences', 'total scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C3496286'}, {'cui': 'C0030351', 'cui_str': 'Paper'}]","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0603712,"There was a statistically significant correlation between experience with touchscreen devices and performance on the eMoCA, but not between modality preference and performance.
","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Wallace', 'Affiliation': 'Departments of Speech-Language Pathology.'}, {'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Donoso Brown', 'Affiliation': 'Occupational Therapy.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Simpson', 'Affiliation': 'Occupational Therapy.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': ""D'Acunto"", 'Affiliation': 'Physician Assistant Studies.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kranjec', 'Affiliation': 'Psychology, Duquesne University, Pittsburgh, PA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Rodgers', 'Affiliation': 'Occupational Therapy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Agostino', 'Affiliation': 'Departments of Speech-Language Pathology.'}]",Alzheimer disease and associated disorders,['10.1097/WAD.0000000000000333']
1259,31455688,"Amount and Type of Dietary Fat, Postprandial Glycemia, and Insulin Requirements in Type 1 Diabetes: A Randomized Within-Subject Trial.","OBJECTIVE


The American Diabetes Association recommends individuals with type 1 diabetes (T1D) adjust insulin for dietary fat; however, optimal adjustments are not known. This study aimed to determine  1 ) the relationship between the amount and type of dietary fat and glycemia and  2 ) the optimal insulin adjustments for dietary fat.
RESEARCH DESIGN AND METHODS


Adults with T1D using insulin pump therapy attended the research clinic on 9-12 occasions. On the first six visits, participants consumed meals containing 45 g carbohydrate with 0 g, 20 g, 40 g, or 60 g fat and either saturated, monounsaturated, or polyunsaturated fat. Insulin was dosed using individual insulin/carbohydrate ratio as a dual-wave 50/50% over 2 h. On subsequent visits, participants repeated the 20-60-g fat meals with the insulin dose estimated using a model predictive bolus, up to twice per meal, until glycemic control was achieved.
RESULTS


With the same insulin dose, increasing the amount of fat resulted in a significant dose-dependent reduction in incremental area under the curve for glucose (iAUC glucose ) in the early postprandial period (0-2 h;  P  = 0.008) and increase in iAUC glucose  in the late postprandial period (2-5 h;  P  = 0.004). The type of fat made no significant difference to the 5-h iAUC glucose . To achieve glycemic control, on average participants required dual-wave insulin bolus: for 20 g fat, +6% insulin, 74/26% over 73 min; 40 g fat, +6% insulin, 63/37% over 75 min; and 60 g fat, +21% insulin, 49/51% over 105 min.
CONCLUSIONS


This study provides clinical guidance for mealtime insulin dosing recommendations for dietary fat in T1D.",2020,The type of fat made no significant difference to the 5-h iAUC glucose .,"['Adults with T1D', 'dietary fat in T1D', 'Type 1 Diabetes']",['insulin pump therapy'],"['incremental area under the curve for glucose (iAUC glucose ', 'iAUC glucose', 'Amount and Type of Dietary Fat, Postprandial Glycemia, and Insulin Requirements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0310742,The type of fat made no significant difference to the 5-h iAUC glucose .,"[{'ForeName': 'Kirstine J', 'Initials': 'KJ', 'LastName': 'Bell', 'Affiliation': 'Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia kirstine.bell@sydney.edu.au.'}, {'ForeName': 'Chantelle Z', 'Initials': 'CZ', 'LastName': 'Fio', 'Affiliation': 'Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Twigg', 'Affiliation': 'Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sally-Anne', 'Initials': 'SA', 'LastName': 'Duke', 'Affiliation': 'Royal North Shore Hospital Diabetes Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital Diabetes Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Alexander', 'Affiliation': 'Royal North Shore Hospital Diabetes Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McGill', 'Affiliation': 'Royal Prince Alfred Hospital Diabetes Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jencia', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Royal Prince Alfred Hospital Diabetes Centre, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Garry M', 'Initials': 'GM', 'LastName': 'Steil', 'Affiliation': 'Harvard Medical School, Boston, MA.'}]",Diabetes care,['10.2337/dc19-0687']
1260,31437287,Feasibility of Motivational Interviewing to Engage Older Inpatients in Fall Prevention: A Pilot Randomized Controlled Trial.,"In the current 3-month, two arm, unblinded, single site, pilot randomized controlled trial, 120 high fall risk hospitalized older adults (age ≥65) were contacted, and 67 participants were enrolled. The intervention arm received a brief motivational interviewing (MI) intervention. Both arms received routine hospital fall prevention protocols. Measurements were conducted at baseline, 2 days, 1 week, 1 month, and 3 months. MI intervention took approximately 21 minutes and was provided at beginning proficiency level. Approximately 66% of participants completed 3-month data collection. The intervention group reported a greater decrease in fear of falling after the intervention than the control arm (β = -0.856 vs. β = -0.236) and maintained fall prevention behaviors at 3 months (β = 0.001 vs. β = -0.083) (p < 0.05). The current study found brief MI for fall prevention in acute settings feasible and provided preliminary evidence for a positive impact of MI [Journal of Gerontological Nursing, 45(9), 19-29.].",2019,The intervention group reported a greater decrease in fear of falling after the intervention than the control arm (β = -0.856 vs. β = -0.236) and maintained fall prevention behaviors at 3 months (β = 0.001 vs. β = -0.083) (p < 0.05).,"['120 high fall risk hospitalized older adults (age ≥65) were contacted, and 67 participants were enrolled', 'Engage Older Inpatients in Fall Prevention']","['brief motivational interviewing (MI) intervention', 'routine hospital fall prevention protocols', 'Motivational Interviewing', 'MI intervention']",['fear of falling'],"[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}]",120.0,0.0391665,The intervention group reported a greater decrease in fear of falling after the intervention than the control arm (β = -0.856 vs. β = -0.236) and maintained fall prevention behaviors at 3 months (β = 0.001 vs. β = -0.083) (p < 0.05).,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kiyoshi-Teo', 'Affiliation': ''}, {'ForeName': 'Kathlynn', 'Initials': 'K', 'LastName': 'Northup-Snyder', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dieckmann', 'Affiliation': ''}, {'ForeName': 'Sydnee', 'Initials': 'S', 'LastName': 'Stoyles', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eckstrom', 'Affiliation': ''}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Winters-Stone', 'Affiliation': ''}]",Journal of gerontological nursing,['10.3928/00989134-20190813-03']
1261,31366262,Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial.,"Objective:  To examine patient preference for treatment with the oral once-weekly dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin, administered for 8 weeks each in patients with type 2 diabetes mellitus prescribed a daily DPP-4i. Methods:  In this randomized, open-label, two-way crossover study, patients received trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin (A-T group), for 8 weeks each (NCT03231709, JapicCTI-173662). Treatment preference was assessed using a standardized questionnaire in the overall population and by baseline characteristics. Other outcomes included patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels after 8 weeks of treatment with each agent, and safety. Results:  Sixty patients from two clinical sites were randomized 1:1 to T-A and A-T groups (each  n  = 30); baseline characteristics were similar between groups. After 16 weeks of treatment, 51.7% of patients preferred treatment with alogliptin compared with 30.0% selecting trelagliptin ( p  = .014); preference for alogliptin was consistently greater than for trelagliptin in the secondary analyses by baseline characteristics. DTSQ score and HbA1c levels were similar between treatments after 8 weeks of therapy. Both treatments demonstrated favorable safety and tolerability profiles. Conclusions:  Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments. The decision to administer a once-weekly or once-daily DPP-4i is likely to depend on patient preference, patient-physician discussions, and treatment practices of the prescribing physician.",2019,"Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments.","['patients with type 2 diabetes mellitus', 'Sixty patients from two clinical sites', 'patients with type 2 diabetes mellitus prescribed a daily DPP-4i']","['alogliptin', 'dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin', 'DPP-4 inhibitors', 'trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin']","['favorable safety and tolerability profiles', 'DTSQ score and HbA1c levels', 'patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels', 'preference for alogliptin', 'safety', 'patient satisfaction and HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C4045234', 'cui_str': 'trelagliptin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire (assessment scale)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}]",60.0,0.142705,"Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Meguro', 'Affiliation': 'Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2019.1651130']
1262,31813230,"Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study.","OBJECTIVE


Previous randomised, double-blind, placebo-controlled studies have shown that Kava (a South Pacific medicinal plant) reduced anxiety during short-term administration. The objective of this randomised, double-blind, placebo-controlled study was to perform a larger, longer-term trial assessing the efficacy and safety of Kava in the treatment of generalised anxiety disorder and to determine whether gamma-aminobutyric acid transporter (SLC6A1) single-nucleotide polymorphisms were moderators of response.
METHODS


The trial was a phase III, multi-site, two-arm, 16-week, randomised, double-blind, placebo-controlled study investigating an aqueous extract of dried Kava root administered twice per day in tablet form (standardised to 120 mg of kavalactones twice/day) in 171 currently non-medicated anxious participants with diagnosed generalised anxiety disorder. The trial took place in Australia.
RESULTS


An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points;  p  = 0.25). At the conclusion of the controlled phase, 17.4% of the Kava group were classified as remitted (Hamilton Anxiety Rating Scale score < 7) compared to 23.8% of the placebo group ( p  = 0.46). No SLC6A1 polymorphisms were associated with treatment response, while carriers of the rs2601126 T allele preferentially respond to placebo ( p  = 0.006). Kava was well tolerated aside from poorer memory (Kava = 36 vs placebo = 23;  p  = 0.044) and tremor/shakiness (Kava = 36 vs placebo = 23;  p  = 0.024) occurring more frequently in the Kava group. Liver function test abnormalities were significantly more frequent in the Kava group, although no participant met criteria for herb-induced hepatic injury.
CONCLUSION


While research has generally supported Kava in non-clinical populations (potentially for more 'situational' anxiety as a short-term anxiolytic), this particular extract was not effective for diagnosed generalised anxiety disorder.",2020,An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points;  p  = 0.25).,"['171 currently non-medicated anxious participants with diagnosed generalised anxiety disorder', 'Kava for generalised anxiety disorder']","['placebo', 'Kava']","['Liver function test abnormalities', 'remitted (Hamilton Anxiety Rating Scale score', 'anxiety', 'anxiety reduction']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0521083', 'cui_str': 'Piper methysticum'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521083', 'cui_str': 'Piper methysticum'}]","[{'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}]",171.0,0.543501,An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points;  p  = 0.25).,"[{'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Byrne', 'Affiliation': 'Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Bousman', 'Affiliation': 'Departments of Medical Genetics, Psychiatry and Physiology & Pharmacology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Cribb', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Savage', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Holmes', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Macdonald', 'Affiliation': 'Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Short', 'Affiliation': 'Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Nazareth', 'Affiliation': 'Discipline of Psychiatry, School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Jennings', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Thomas', 'Affiliation': 'Adjunct Senior Lecturer, Monash University, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ogden', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Chamoli', 'Affiliation': 'Department of Psychiatry, ACT Health, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Con', 'Initials': 'C', 'LastName': 'Stough', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867419891246']
1263,31464343,Vitamin D levels were significantly higher during and after lifestyle intervention in pregnancy: A randomized controlled trial.,"INTRODUCTION


Vitamin D deficiency is common in pregnancy, especially in obese women. Lifestyle intervention could potentially result in higher levels of vitamin D. We therefore aimed to study the effect of lifestyle intervention during pregnancy on serum levels of 25-hydroxyvitamin D (25(OH)D).
MATERIAL AND METHODS


A total of 360 obese women were randomized before gestational age 14 weeks to lifestyle intervention (diet and exercise) or routine clinical follow up (controls). Clinical outcomes and levels of 25(OH)D were determined three times: At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and 6 months postpartum.
RESULTS


A total of 304 (84%) women completed the intervention study and 238 (66%) attended postpartum follow up. Vitamin D levels were similar in the two groups at baseline. At gestational age 28-30 weeks and 6 months postpartum, 25(OH)D levels were significantly higher in the intervention group than in controls (75.6 vs 66.8 nmol/L, P = 0.009) and (54.8 vs 43.1 nmol/L, P = 0.013), respectively. Concurrently, vitamin D deficiency (25-hydroxyvitamin D <50 nmol/L) was less frequent in the intervention group than in controls: 15 vs 25% (P = 0.038) at gestational age 28-30 and 45 vs 63% (P = 0.011) 6 months postpartum, respectively.
CONCLUSIONS


Lifestyle intervention during pregnancy was associated with significantly increased vitamin D levels in late pregnancy and postpartum compared with controls.",2020,"Concurrently, vitamin D deficiency (25(OH)D <50 nmol/L) was less frequent in the intervention group compared to controls: 15% vs. 25% (P = 0.038) at gestational age 28-30 and 45% vs. 63% (P = 0.011) six months postpartum, respectively.
","['A total of 304 (84', '360 obese women were randomised before gestational age 14 weeks to', 'women completed the intervention study, and 238 (66%) attended postpartum follow-up', 'obese women', 'At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and six months postpartum']","['lifestyle intervention', 'lifestyle intervention (diet and exercise) or routine clinical follow-up (controls', 'Lifestyle intervention']","['Vitamin D levels', 'vitamin D levels', 'serum levels of 25-hydroxyvitamin D (25(OH)D', '25(OH)D levels', 'higher levels of Vitamin D']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",360.0,0.0883229,"Concurrently, vitamin D deficiency (25(OH)D <50 nmol/L) was less frequent in the intervention group compared to controls: 15% vs. 25% (P = 0.038) at gestational age 28-30 and 45% vs. 63% (P = 0.011) six months postpartum, respectively.
","[{'ForeName': 'Mette H', 'Initials': 'MH', 'LastName': 'Tanvig', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Dorte M', 'Initials': 'DM', 'LastName': 'Jensen', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Per G', 'Initials': 'PG', 'LastName': 'Ovesen', 'Affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Vinter', 'Affiliation': 'Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13722']
1264,31907828,Evidence for Relationship Between Early Dumping and Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass.,"BACKGROUND


Early dumping and post-bariatric hypoglycemia (PBH) are often addressed as two separate postprandial complications after Roux-en-Y gastric bypass (RYGB). The aim of the study was to evaluate the occurrence of early dumping in RYGB-operated individuals with PBH with and without treatment intervention.
METHODS


Eleven RYGB-operated women with documented PBH each underwent a baseline liquid mixed meal test (MMT) followed by five MMTs preceded by treatment with: acarbose 50 mg for 1 week, sitagliptin 100 mg for 1 week, verapamil 120 mg for 1 week, liraglutide 1.2 mg for 3 weeks, and pasireotide 300 μg as a single dose. Repetitive venous blood sampling and continuous electrocardiogram recordings were performed at fasting and during a 3-h postprandial period.
RESULTS


During the baseline MMT, there was a significant increase in HR (from 65 ± 2 to 90 ± 4 bpm, p < 0.0001) within 30 min after meal intake, while hypoglycemia occurred in the later postprandial period. The HR increase was accompanied by significant increases in serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations. The postprandial HR changes were positively correlated with the changes in insulin and GLP-1 concentrations. Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
CONCLUSIONS


RYGB-operated individuals with PBH also have large early postprandial HR increases, hemoconcentration, and sympathetic activation, consistent with early dumping. Moreover, hormone excursions associated with PBH appear to be related to measures of early dumping, suggesting a causal relationship between early dumping and PBH.
TRIAL REGISTRATION


NCT02527993.",2020,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
","['RYGB-operated individuals with PBH with and without treatment intervention', 'Eleven RYGB-operated women with documented PBH each underwent a']","['acarbose 50\xa0mg for 1\xa0week, sitagliptin 100\xa0mg for 1\xa0week, verapamil', 'liraglutide', 'acarbose and pasireotide', 'baseline liquid mixed meal test (MMT']","['postprandial HR changes', 'Repetitive venous blood sampling and continuous electrocardiogram recordings', 'hemoconcentration, and sympathetic activation', 'insulin and GLP-1 concentrations', 'Postprandial Hypoglycemia', 'hypoglycemia', 'HR', 'HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1', 'serum albumin, plasma norepinephrine, blood glucose, serum insulin, and plasma GLP-1 concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0982924', 'cui_str': 'Acarbose 50 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram (procedure)'}, {'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0271710', 'cui_str': 'Postprandial Hypoglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",11.0,0.0160128,"Treatment with acarbose and pasireotide both reduced HR, plasma norepinephrine, and serum insulin, and pasireotide also decreased plasma GLP-1.
","[{'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Øhrstrøm', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark. carolinechristfort@hotmail.com.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Worm', 'Affiliation': 'Department of Medicine, Amager Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Urd Lynge', 'Initials': 'UL', 'LastName': 'Kielgast', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte L', 'Initials': 'DL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Obesity surgery,['10.1007/s11695-020-04387-6']
1265,30099647,Music Therapy for Coping Self-Efficacy in an Acute Mental Health Setting: A Randomized Pilot Study.,"For adults with mental illness, coping skills represent an integral component of illness management and recovery (IMR) programs. Music therapy can be used to target IMR but empirical research specific to coping is needed. The purpose of this study was to determine if educational music therapy can influence coping self-efficacy in acute care mental health inpatients. Adults on an acute care mental health unit (N = 92) were cluster-randomized to one of three single-session conditions over 24 group-based sessions: educational lyric analysis, educational songwriting, or control. Although results were not significant, both educational music therapy conditions tended to have more favorable coping self-efficacy subscale means than the control condition but there were negligible differences between lyric analysis and songwriting conditions. Results can be considered clinically relevant within the temporal parameters of single-session therapy typical in acute care settings. Limitations, implications for practice, and suggestions for future research are included.",2019,"Although results were not significant, both educational music therapy conditions tended to have more favorable coping self-efficacy subscale means than the control condition but there were negligible differences between lyric analysis and songwriting conditions.","['adults with mental illness', 'Adults on an acute care mental health unit (N\u2009=\u200992', 'acute care mental health inpatients', 'Acute Mental Health Setting']","['single-session conditions over 24 group-based sessions: educational lyric analysis, educational songwriting, or control', 'educational music therapy', 'Music Therapy', 'Music therapy']",['favorable coping self-efficacy subscale means'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",92.0,0.0362388,"Although results were not significant, both educational music therapy conditions tended to have more favorable coping self-efficacy subscale means than the control condition but there were negligible differences between lyric analysis and songwriting conditions.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverman', 'Affiliation': 'University of Minnesota School of Music, 2106 4th Street South, Minneapolis, MN, 55455, USA. silvermj@umn.edu.'}]",Community mental health journal,['10.1007/s10597-018-0319-8']
1266,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND


Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer.
METHODS


This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2  of intravenous oxaliplatin or 80 mg/m 2  of cisplatin on day 1, 850 mg/m 2  of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2  per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment.
FINDINGS


Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths.
INTERPRETATION


Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway.
FUNDING


Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8']
1267,32437332,Robust antibody and cellular responses induced by DNA-only vaccination for HIV.,"BACKGROUNDHVTN 098, a randomized, double-blind, placebo-controlled trial, evaluated the safety, tolerability, and immunogenicity of PENNVAX-GP HIV DNA vaccine, administered with or without plasmid IL-12 (pIL-12), via intradermal (ID) or intramuscular (IM) electroporation (EP) in healthy, HIV-uninfected adults. The study tested whether PENNVAX-GP delivered via ID/EP at one-fifth the dose could elicit equivalent immune responses to delivery via IM/EP and whether inclusion of pIL-12 provided additional benefit.METHODSParticipants received DNA encoding HIV-1 env/gag/pol in 3 groups: 1.6 mg ID (ID no IL-12 group, n = 20), 1.6 mg ID + 0.4 mg pIL-12 (ID + IL-12 group, n = 30), 8 mg IM + 1 mg pIL-12 (IM + IL-12 group, n = 30), or placebo (n = 9) via EP at 0, 1, 3, and 6 months. Results of cellular and humoral immunogenicity assessments are reported.RESULTSFollowing vaccination, the frequency of responders (response rate) to any HIV protein based on CD4+ T cells expressing IFN-γ or IL-2 was 96% for both the ID + IL-12 and IM + IL-12 groups; CD8+ T cell response rates were 64% and 44%, respectively. For ID delivery, the inclusion of pIL-12 increased CD4+ T cell response rate from 56% to 96%. The frequency of responders was similar (≥90%) for IgG binding antibody to gp140 consensus Env across all groups, but the magnitude was higher in the ID + IL-12 group compared with the IM + IL-12 group.CONCLUSIONPENNVAX-GP DNA induced robust cellular and humoral immune responses, demonstrating that immunogenicity of DNA vaccines can be enhanced by EP route and inclusion of pIL-12. ID/EP was dose sparing, inducing equivalent, or in some aspects superior, immune responses compared with IM/EP.TRIAL REGISTRATIONClinicalTrials.gov NCT02431767.FUNDINGThis work was supported by National Institute of Allergy and Infectious Diseases (NIAID), U.S. Public Health Service grants, an HIV Vaccine Design and Development Team contract, Integrated Preclinical/Clinical AIDS Vaccine Development Program, and an NIH award.",2020,"The frequency of responders was similar (>90%) for IgG binding Ab to gp140 consensus Env across all groups, but the magnitude was higher in the ID+IL-12 group compared to the IM+IL-12 group.
","['healthy, HIV-uninfected adults']","['PENNVAX®-GP HIV DNA vaccine, administered with or without plasmid IL-12 (pIL-12), via intradermal (ID) or intramuscular (IM) electroporation (EP', 'PENNVAX®-GP delivered via ID/EP', 'ID + 0.4mg pIL-12 (ID+IL-12 group, n=30), 8mg IM + 1mg pIL-12 (IM+IL-12 group, n=30) or placebo', 'DNA encoding HIV-1 env/gag/pol in three groups: 1.6mg ID (ID no IL-12', 'placebo']","['safety, tolerability and immunogenicity', 'pIL-12 increased CD4+ T-cell response rate', 'CD8+ T-cell response rates', 'frequency of responders', 'frequency of responders (response rate) to any HIV protein based on CD4+ T-cells expressing IFN-γ and/or IL-2']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1955876', 'cui_str': 'HIV Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]",,0.396959,"The frequency of responders was similar (>90%) for IgG binding Ab to gp140 consensus Env across all groups, but the magnitude was higher in the ID+IL-12 group compared to the IM+IL-12 group.
","[{'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Elizaga', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'Division of AIDS, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Polakowski', 'Affiliation': 'Division of AIDS, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Kalams', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Wise', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Morrow', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Khan', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Jean D', 'Initials': 'JD', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Humeau', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pensiero', 'Affiliation': 'Division of AIDS, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Niranjan Y', 'Initials': 'NY', 'LastName': 'Sardesai', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Bagarazzi', 'Affiliation': 'Inovio Pharmaceuticals Inc., Plymouth Meeting, Pennsylvania, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Weiner', 'Affiliation': 'Wistar Institute, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.137079']
1268,32441833,"Comparison of the clinical efficacy of daily use of L-arginine, tadalafil and combined L-arginine with tadalafil in the treatment of elderly patients with erectile dysfunction.","This study aimed to evaluate the efficacy of the daily oral administrations of L-arginine, tadalafil and combined L-arginine with tadalafil in treatments of elderly patients with erectile dysfunction (ED). It was designed as a single-blind placebo-controlled clinical trial. It was conducted on 120 male patients aged ≥60 years old with ED. Patients were randomised classified into four groups (n = 30 each). Oral daily use of L-arginine (5 g), tadalafil (5 mg), combined L-arginine (5 g) with tadalafil (5 mg) and placebo were taken for 6 weeks in each group of patients respectively. Patients were assessed before and after treatments using the Sexual Health Inventory for Men (SHIM) questionnaire and total serum testosterone. The means of Q1-5, total scores of SHIM and total testosterone, in L-arginine, tadalafil and combined L-arginine with tadalafil groups were significantly higher after treatments (p = .001). Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone. This clinical trial deduced that the combined daily use of L-arginine with tadalafil therapy for elderly male patients with ED could significantly increase the SHIM scores and levels of total testosterone in comparison to L-arginine, or tadalafil alone.",2020,Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone.,"['elderly patients with erectile dysfunction (ED', '120 male patients aged ≥60\xa0years old with ED', 'elderly male patients with ED', 'elderly patients with erectile dysfunction']","['L-arginine, tadalafil and combined L-arginine with tadalafil', 'L-arginine (5\xa0g), tadalafil (5\xa0mg), combined L-arginine', 'tadalafil', 'L-arginine with tadalafil therapy', 'Combined L-arginine with tadalafil', 'placebo']","['means of Q1-5, total scores of SHIM and total testosterone, in L-arginine, tadalafil and combined L-arginine', 'SHIM scores and levels of total testosterone', 'Sexual Health Inventory for Men (SHIM) questionnaire and total serum testosterone', 'highest SHIM scores and levels of total testosterone']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472504', 'cui_str': 'Sexual health inventory for men'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}]",120.0,0.0406742,Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abu El-Hamd', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Eisa Mohammed', 'Initials': 'EM', 'LastName': 'Hegazy', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, South Valley University, Qena, Egypt.'}]",Andrologia,['10.1111/and.13640']
1269,31432758,Effect of board game activities on cognitive function improvement among older adults in adult day care centers.,"Stimulating leisure activities are considered as possible protective factors against dementia and cognitive decline in older adults, particularly due to the enhancement of cognitive reserve. This study tested the effectiveness of board game activities improving the cognitive function of older adults in adult day care centers. This was a quasi-experimental study. A purposive sampling strategy was used to select 82 subjects who were aged 65 and above with intact mental functions and currently residing in adult day care centers. 41 subjects who participated in a selection of 12 board game activities were assigned to the experimental group and 41 subjects who adhered to their ordinary activities were allocated to the control group. Structured questionnaires of the board game programs were used for data collection. The board game programs showed promising effects in the cognitive function of older adults living in adult day care centers. A possible beneficial effect of board game playing on the risk of dementia could be mediated by a less cognitive decline in older adults. Board game activities may benefit the cognitive function of older adults. Incorporating board game activities into social work care may help develop long-term care into a more diverse, unique and innovative direction.",2019,A possible beneficial effect of board game playing on the risk of dementia could be mediated by a less cognitive decline in older adults.,"['41 subjects who participated in a selection of 12 board game activities were assigned to the experimental group and 41 subjects who adhered to their ordinary activities', 'older adults living in adult day care centers', 'older adults in adult day care centers', 'older adults', '82 subjects who were aged 65 and above with intact mental functions and currently residing in adult day care centers']","['board game activities', 'board game playing']",['cognitive function improvement'],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268939', 'cui_str': 'Adult Day Care Centers'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",82.0,0.0229719,A possible beneficial effect of board game playing on the risk of dementia could be mediated by a less cognitive decline in older adults.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Ching-Teng', 'Affiliation': 'Master Program of Long-Term Care in Aging, Kaohsiung Medical University , Kaohsiung , Taiwan.'}]",Social work in health care,['10.1080/00981389.2019.1656143']
1270,32007138,"Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAF V600 -mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial.","BACKGROUND


Adjuvant dabrafenib plus trametinib reduced the risk of relapse versus placebo in patients with resected, BRAF V600 -mutant, stage III melanoma in the phase 3 COMBI-AD trial. This prespecified exploratory biomarker analysis aimed to evaluate potential prognostic or predictive factors and mechanisms of resistance to adjuvant targeted therapy.
METHODS


COMBI-AD is a randomised, double-blind, placebo-controlled, phase 3 trial comparing dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally once daily versus two matched placebos. Study participants were at least 18 years of age and underwent complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma, per American Joint Committee on Cancer 7th edition criteria, with a BRAF V600E  or BRAF V600K  mutation. Patients were randomly assigned (1:1) to the two treatment groups by an interactive voice response system, stratified by mutation type and disease stage. Patients, physicians, and the investigators who analysed data were masked to treatment allocation. The primary outcome was relapse-free survival, defined as the time from randomisation to disease recurrence or death from any cause. Biomarker assessment was a prespecified exploratory outcome of the trial. We assessed intrinsic tumour genomic features by use of next-generation DNA sequencing and characteristics of the tumour microenvironment by use of a NanoString RNA assay, which might provide prognostic and predictive information. This trial is registered with ClinicalTrials.gov, number NCT01682083, and is ongoing but no longer recruiting participants.
FINDINGS


Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled in the trial. Median follow-up at data cutoff (April 30, 2018) was 44 months (IQR 38-49) in the dabrafenib plus trametinib group and 42 months (21-49) in the placebo group. Intrinsic tumour genomic features were assessed in 368 patients (DNA sequencing set) and tumour microenvironment characteristics were assessed in 507 patients (NanoString biomarker set). MAPK pathway genomic alterations at baseline did not affect treatment benefit or clinical outcome. An IFNγ gene expression signature higher than the median was prognostic for prolonged relapse-free survival in both treatment groups. Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44). Patients with tumour mutational burden in the lower two terciles seem to derive a substantial long-term relapse-free survival benefit from targeted therapy (HR [versus placebo] 0·49, 95% CI 0·35-0·68, p<0·0001). However, patients with high tumour mutational burden seem to have a less pronounced benefit with targeted therapy (HR [versus placebo] 0·75, 95% CI 0·44-1·26, p=0·27), especially if they had an IFNγ signature lower than the median (HR 0·88 [95% CI 0·40-1·93], p=0·74).
INTERPRETATION


Tumour mutational burden alone or in combination with IFNγ gene expression signature or other markers for an adaptive immune response might be of relevance for identifying patients with stage III melanoma who might derive clinical benefit from targeted therapy. Further validation in prospective clinical trials is warranted.
FUNDING


Novartis Pharmaceuticals.",2020,"Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44).","['368 patients (DNA sequencing set) and tumour microenvironment characteristics were assessed in 507 patients (NanoString biomarker set', 'Study participants were at least 18 years of age and underwent complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma, per American Joint Committee on Cancer 7th edition criteria, with a BRAF V600E  or BRAF V600K  mutation', 'patients with stage III melanoma', 'patients with resected, BRAF V600 -mutant, stage III melanoma (COMBI-AD', 'patients with resected, BRAF V600 -mutant, stage III melanoma in the phase 3 COMBI-AD trial', 'Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled in the trial', '0·49']","['placebo', 'Adjuvant dabrafenib plus trametinib versus placebo', 'dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally once daily versus two matched placebos']","['risk of relapse', 'relapse-free survival', 'substantial long-term relapse-free survival benefit', 'relapse-free survival, defined as the time from randomisation to disease recurrence or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917792', 'cui_str': 'DNA Sequencing'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3644516', 'cui_str': 'trametinib 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",870.0,0.798016,"Tumour mutational burden was independently prognostic for relapse-free survival in the placebo group (high TMB, top third; hazard ratio [HR] 0·56, 95% CI 0·37-0·85, p=0·0056), but not in the dabrafenib plus trametinib group (0·83, 95% CI 0·53-1·32, p=0·44).","[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Catarina D', 'Initials': 'CD', 'LastName': 'Campbell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Macquarie University and Westmead Hospital, Sydney, NSW, Australia; Melanoma Institute Australia and The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia and The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30062-0']
1271,31428854,Urinary markers of hydration during 3-day water restriction and graded rehydration.,"PURPOSE


This investigation had three purposes: (a) to evaluate changes in hydration biomarkers in response to a graded rehydration intervention (GRHI) following 3 days of water restriction (WR), (b) assess within-day variation in urine concentrations, and (c) quantify the volume of fluid needed to return to euhydration as demonstrated by change in U col .
METHODS


115 adult males and females were observed during 1 week of habitual fluid intake, 3 days of fluid restriction (1000 mL day -1 ), and a fourth day in which the sample was randomized into five different GRHI groups: no additional water, CON; additional 500 mL, G +0.50 ; additional 1000 mL, G +1.00 ; additional 1500 mL, G +1.50 ; additional 2250 mL, G +2.25 . All urine was collected on 1 day of the baseline week, during the final 2 days of the WR, and during the day of GRHI, and evaluated for urine osmolality, color, and specific gravity.
RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON. The mean volume of water increase was significantly greater for those whose U col  changed from > 4 to < 4 (+ 1435 ± 812 mL) than those whose U col  remained ≥ 4 (+ 667 ± 722 mL, p < 0.001).
CONCLUSIONS


An additional 500 mL of water is not sufficient, while approximately 1500 mL of additional water (for a total intake between 2990 and 3515 mL day -1 ) is required to return to a urine color associated with adequate water intake, following 3 days of WR.",2020,"RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON.",['115 adult males and females'],"['GRHI groups: no additional water, CON; additional 500\xa0mL, G +0.50 ; additional 1000\xa0mL, G +1.00 ; additional 1500\xa0mL, G +1.50 ; additional 2250\xa0mL, G +2.25 ']","['urine osmolality, color, and specific gravity', 'mean volume of water increase']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine (procedure)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0037786', 'cui_str': 'Relative Density'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",115.0,0.0719872,"RESULTS


Following the GRHI, only G +1.50  and G +2.25  resulted in all urinary values being significantly different from CON.","[{'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA. evancjohnson@gmail.com.'}, {'ForeName': 'Ainsley E', 'Initials': 'AE', 'LastName': 'Huffman', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Yoder', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, 1000 E. University Ave, Laramie, WY, 82071, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dolci', 'Affiliation': 'Danone Research, Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Danone Research, Palaiseau, France.'}, {'ForeName': 'D Enette', 'Initials': 'DE', 'LastName': 'Larson-Meyer', 'Affiliation': 'Department of Family and Consumer Sciences, University of Wyoming, Laramie, WY, USA.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Armstrong', 'Affiliation': 'Hydration & Nutrition, LLC, Newport News, VA, USA.'}]",European journal of nutrition,['10.1007/s00394-019-02065-7']
1272,31279814,In-depth genomic analyses identified novel letermovir resistance-associated substitutions in the cytomegalovirus UL56 and UL89 gene products.,"Letermovir is a human cytomegalovirus (HCMV) terminase inhibitor recently approved in the United States for prophylaxis of HCMV infection or disease in adult HCMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant. In the registrational trial, the rate of clinically significant HCMV infection, defined as the development of HCMV DNAemia leading to preemptive antiviral therapy or the diagnosis of HCMV end-organ disease, through 24 weeks post-transplant, was significantly lower among subjects who received letermovir prophylaxis through 14 weeks post-transplant compared to those who received placebo. We performed independent analyses of the HCMV nucleotide sequencing data generated by next-generation sequencing from this phase 3 registrational trial of letermovir to identify viral genetic characteristics associated with virologic failure during and following letermovir prophylaxis. The pUL56 substitutions V236M, E237G, and C325W, identified at previously known resistance-associated positions, were detected in the virus of subjects who were treated with letermovir and failed letermovir prophylaxis. Several additional substitutions were detected in pUL56 and pUL89, and further characterization is needed to determine if any of these substitutions are clinically relevant. The analyses reported herein were conducted to confirm sponsor-reported drug-resistance pathways, to assess the frequency of resistance, and to better understand the risk of prophylaxis failures and treatment-emergent drug resistance.",2019,Letermovir is a human cytomegalovirus (HCMV) terminase inhibitor recently approved in the United States for prophylaxis of HCMV infection or disease in adult HCMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.,['adult HCMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant'],['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0317413,Letermovir is a human cytomegalovirus (HCMV) terminase inhibitor recently approved in the United States for prophylaxis of HCMV infection or disease in adult HCMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.,"[{'ForeName': 'Takashi E', 'Initials': 'TE', 'LastName': 'Komatsu', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA. Electronic address: takashi.komatsu@fda.hhs.gov.'}, {'ForeName': 'Aimee C', 'Initials': 'AC', 'LastName': 'Hodowanec', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA. Electronic address: aimee.hodowanec@fda.hhs.gov.'}, {'ForeName': 'Anamaris M', 'Initials': 'AM', 'LastName': 'Colberg-Poley', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pikis', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Singer', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA.'}, {'ForeName': 'Julian J', 'Initials': 'JJ', 'LastName': ""O'Rear"", 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Donaldson', 'Affiliation': 'Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, USA. Electronic address: eric.donaldson@fda.hhs.gov.'}]",Antiviral research,['10.1016/j.antiviral.2019.104549']
1273,32141188,Long-term effects of a healthy eating blog in mothers and children.,"In the context of low consumption of vegetables and fruits and milk and alternatives among Canadian mothers and children, novel strategies are needed to improve maternal and child nutrition. This study evaluated the long-term effects of an evidence-informed healthy eating blog on dietary intakes and food-related behaviours of mothers and their child. The study presents a secondary outcome analysis of a randomised controlled trial in which 84 mothers (mean age of 37.6 ± 6.7 years) of 2- to 12-year-old children living in Quebec City, Canada, were randomly assigned to a dietary intervention delivered through a healthy eating blog written by a registered dietitian (RD; n = 42) or a control group (n = 42) during a period of 6 months. Dietary intakes, maternal eating behaviours, food parenting practices, and body weight were measured at baseline, 3 months, at the end of the intervention (6 months), and 6-month post-intervention (12 months). Differences between groups were assessed with mixed linear models. Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition. Potential predictors of adherence to dietary recommendations in mothers and children (e.g., involvement of children in household food activities) were identified. In conclusion, a healthy eating blog written by an RD did not result in evidence of any long-term differences in dietary intakes and food-related behaviours in mothers and their children compared with the control condition.",2020,"Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition.","['84 mothers (mean age of 37.6 ± 6.7 years) of 2- to 12-year-old children living in Quebec City, Canada', 'Canadian mothers and children', 'mothers and their child', 'mothers and children (e.g., involvement of children in household food activities', 'healthy eating blog in mothers and children']",['dietary intervention delivered through a healthy eating blog written by a registered dietitian (RD; n = 42) or a control group'],"['mean dietary intakes', 'Dietary intakes, maternal eating behaviours, food parenting practices, and body weight', 'dietary intakes and food-related behaviours']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2718046', 'cui_str': 'Blog'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",84.0,0.0599462,"Globally, this study found no evidence of long-term differences in mean dietary intakes in mothers exposed to the blog and their children as well as other food-related outcomes and body weight compared with the control condition.","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': 'Institute of Nutrition and Functional Foods, Centre de recherche Nutrition, Santé et Société (NUTRISS), Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, School of Nutrition, Faculty of Agriculture and Food Sciences, Université Laval, Quebec City, Quebec, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.12981']
1274,31980691,Nutrimetabolomics reveals food-specific compounds in urine of adults consuming a DASH-style diet.,"Although health benefits of the Dietary Approaches to Stop Hypertension (DASH) diet are established, it is not understood which food compounds result in these benefits. We used metabolomics to identify unique compounds from individual foods of a DASH-style diet and determined if these Food-Specific Compounds (FSC) are detectable in urine from participants in a DASH-style dietary study. We also examined relationships between urinary compounds and blood pressure (BP). Nineteen subjects were randomized into 6-week controlled DASH-style diet interventions. Mass spectrometry-based metabolomics was performed on 24-hour urine samples collected before and after each intervention and on 12 representative DASH-style foods. Between 66-969 compounds were catalogued as FSC; for example, 4-hydroxydiphenylamine was found to be unique to apple. Overall, 13-190 of these FSC were detected in urine, demonstrating that these unmetabolized food compounds can be discovered in urine using metabolomics. Although linear mixed effects models showed no FSC from the 12 profiled foods were significantly associated with BP, other endogenous and food-related compounds were associated with BP (N = 16) and changes in BP over time (N = 6). Overall, this proof of principle study demonstrates that metabolomics can be used to catalog FSC, which can be detected in participant urine following a dietary intervention.",2020,"Although linear mixed effects models showed no FSC from the 12 profiled foods were significantly associated with BP, other endogenous and food-related compounds were associated with BP (N = 16) and changes in BP over time","['Nineteen subjects', 'urine of adults consuming a DASH-style diet']",['controlled DASH-style diet interventions'],"['BP over time', 'blood pressure (BP']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",19.0,0.0135369,"Although linear mixed effects models showed no FSC from the 12 profiled foods were significantly associated with BP, other endogenous and food-related compounds were associated with BP (N = 16) and changes in BP over time","[{'ForeName': 'Nichole A', 'Initials': 'NA', 'LastName': 'Reisdorph', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA. Nichole.Reisdorph@CUAnschutz.edu.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Hendricks', 'Affiliation': 'Mathematical and Statistical Sciences, University of Colorado Denver, Denver, Colorado, USA.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, 12700 E 19th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Doenges', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Reisdorph', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Tooker', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Quinn', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Borengasser', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, 12700 E 19th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Nkrumah-Elie', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Boulevard, Aurora, CO, 80045, USA.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Frank', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, 12700 E. 19th Ave, Aurora, CO, 80045, USA.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State Street, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, 12700 E 19th Avenue, Aurora, CO, 80045, USA.'}]",Scientific reports,['10.1038/s41598-020-57979-8']
1275,31077827,Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We analyzed inflammation, lipid concentrations, and incidence rates of major adverse cardiovascular (CV) events (MACEs) in patients who received tofacitinib in worldwide studies.
METHODS


We collected data from 1157 patients who participated in 3 8-week induction studies (1 phase-2 study and 2 phase-3 studies; patients received tofacitinib 10 mg twice daily or placebo), a 52-week phase-3 maintenance study of responders (patients received tofacitinib 5 or 10 mg twice daily or placebo), and an ongoing long-term extension study of patients who did and did not respond to induction or maintenance therapy (patients received tofacitinib 5 or 10 mg twice daily). Lipid concentrations were assessed from induction baseline to week 61 (week 52 of maintenance therapy). We calculated MACE incidence rates (patients with ≥1 event per 100 patient-years of exposure) and Reynolds risk score (RRS; a composite score used to determine CV risk) for patients given tofacitinib vs placebo.
RESULTS


The mean RRS was <5% at baseline and week 8 of treatment with tofacitinib. At week 8, there were greater increases from baseline in total cholesterol, high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol in patients given tofacitinib compared with placebo. There were correlations between reduced levels of high-sensitivity C-reactive protein and increased serum concentrations of lipid in patients given tofacitinib or placebo (P < .001). Lipid concentrations were increased in patients given tofacitinib vs patients given placebo through week 61. Overall, ratios of low-density lipoprotein cholesterol to HDL-c and total cholesterol to HDL-c did not change significantly over the 61-week period. Four MACEs were reported; the incidence rate was 0.24 (95% CI, 0.07-0.62) and 3 of these patients had 4 or more CV risk factors.
CONCLUSIONS


In an analysis of data from 5 trials of patients with UC who received tofacitinib, we found reversible increases in lipids with treatment and inverse correlations with reduced levels of high-sensitivity C-reactive protein. We did not find clinically meaningful changes in lipid ratios or RRS. MACEs were infrequent and not dose-related. Clinicaltrials.gov: A3921063 (NCT00787202); OCTAVE Induction 1 (NCT01465763); OCTAVE Induction 2 (NCT01458951); OCTAVE Sustain (NCT01458574); OCTAVE Open (NCT01470612).",2020,"Overall, ratios of low-density lipoprotein cholesterol to HDL-c and total cholesterol to HDL-c did not change significantly over the 61-week period.","['patients who received tofacitinib in worldwide studies', '1157 patients who participated in 3 8-week induction studies (1 phase-2 study and 2 phase-3 studies; patients received', 'Patients With Ulcerative Colitis']","['placebo', 'tofacitinib', 'tofacitinib 10 mg twice daily or placebo', 'tofacitinib 5 or 10 mg twice daily or placebo', 'tofacitinib vs placebo', 'Tofacitinib', 'ongoing long-term extension study of patients who did and did not respond to induction or maintenance therapy (patients received tofacitinib 5 or 10 mg twice daily']","['total cholesterol, high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol', 'mean RRS', 'levels of high-sensitivity C-reactive protein and increased serum concentrations of lipid', 'Lipid concentrations', 'incidence rate', 'MACE incidence rates', 'lipid ratios or RRS', 'inflammation, lipid concentrations, and incidence rates of major adverse cardiovascular (CV) events (MACEs', 'Overall, ratios of low-density lipoprotein cholesterol to HDL-c and total cholesterol to HDL-c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C4704009', 'cui_str': 'tofacitinib 10 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4.0,0.603757,"Overall, ratios of low-density lipoprotein cholesterol to HDL-c and total cholesterol to HDL-c did not change significantly over the 61-week period.","[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: bruce.sands@mssm.edu.'}, {'ForeName': 'Pam R', 'Initials': 'PR', 'LastName': 'Taub', 'Affiliation': 'Division of Cardiovascular Medicine, UC San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'IBD Unit, Presidio Columbus Fondazione Policlinico A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Friedman', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moscariello', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Nervin', 'Initials': 'N', 'LastName': 'Lawendy', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Pedersen', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Chudy I', 'Initials': 'CI', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Quirk', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Salese', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Western University, London, Canada.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.04.059']
1276,32438338,"A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.","BACKGROUND


Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV.
OBJECTIVE


This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms.
METHODS


Women (age ≥18 years) who were followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable-T1 and T2 values will be compared with values at T0 by the study group.
RESULTS


As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system.
CONCLUSIONS


The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17656.",2020,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","['54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers', 'minority women living with HIV (WLWH', 'ethnic minority women', ""Women (aged ≥18 years) followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed) will be enrolled"", 'Women Living With HIV']","['Mobile health (mHealth) solutions', 'health reminders and psychoeducational messaging, plus clinic standard of care reminders']","['feasibility and acceptability', ""changes in self-reported medication adherence, depressive symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records""]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",54.0,0.132302,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","[{'ForeName': 'Lunthita M', 'Initials': 'LM', 'LastName': 'Duthely', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Sanchez-Covarrubias', 'Affiliation': 'Miami Clinical and Translational Sciences Institute, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Adhar B', 'Initials': 'AB', 'LastName': 'Mohamed', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'JoNell E', 'Initials': 'JE', 'LastName': 'Potter', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}]",JMIR research protocols,['10.2196/17656']
1277,31817080,The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial.,"The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [ n  = 33 in the intervention group (IG) and  n  = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%,  p  = 0.002, and 67.7%,  p  = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43-1.87). No significant differences in the prevalence of MetS and its features were found between the groups.",2019,"At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%,  p  = 0.002, and 67.7%,  p  = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43-1.87).","['Sixty-seven hospitalized schizophrenic patients with MetS [ n  = 33 in the intervention group (IG) and  n  = 34 in the control group (CG', 'people with schizophrenia', 'Hospitalized Schizophrenic Patients']","['nutrition counseling program', 'Dietary Approaches to Stop Hypertension (DASH) Diet']","['prevalence of MetS', 'Anthropometric and biochemical parameters and blood pressure', 'MetS prevalence']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",67.0,0.0377791,"At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%,  p  = 0.002, and 67.7%,  p  = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43-1.87).","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sorić', 'Affiliation': 'Psychiatric Hospital Ugljan, Otočkih dragovoljaca 42, 23275 Ugljan, Croatia.'}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Mavar', 'Affiliation': 'Psychiatric Hospital Ugljan, Otočkih dragovoljaca 42, 23275 Ugljan, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rumbak', 'Affiliation': 'Faculty of Food Technology and Biotechnology, University of Zagreb, 10000 Zagreb, Croatia.'}]",Nutrients,['10.3390/nu11122950']
1278,31422458,Oral versus patient-controlled intravenous administration of oxycodone for pain relief after cesarean section.,"PURPOSE


The optimal postoperative analgesia after cesarean section (CS) remains to be determined. The primary objective of this study was to assess whether oral oxycodone provides the same or better pain control and satisfaction with pain relief as oxycodone given intravenously using a patient-controlled analgesia (PCA) infusion device. The secondary objectives were to compare the gastrointestinal symptoms and postsurgical recovery of the two groups.
METHODS


This prospective randomized trial was conducted at a University Hospital between February 2015 and June 2017. Altogether 270 CS patients were randomly assigned to receive postoperative oxycodone pain relief by IV PCA (n = 133) or orally (n = 137). Pain control and satisfaction with pain treatment were assessed by a numeric rating scale (NRS) at 2, 4, 8, and 24 h postoperatively.
RESULTS


No differences were found in NRS pain scores or satisfaction between the groups except at 24 h pain when coughing; there was a statistically significant difference favoring the IV PCA group (p = 0.006). In the IV PCA group, the patients experienced more nausea at 4 h (p = 0.001) and more vomiting at 8 h (p = 0.010). Otherwise, postoperative recovery was similar in both groups. The equianalgesic dose of oxycodone was significantly smaller in the oral group (p = 0.003).
CONCLUSIONS


This study indicates that oral oxycodone provides pain control and satisfaction with pain relief equal to IV oxycodone PCA for postoperative analgesia after cesarean section. Satisfaction with pain treatment was high in both groups, and both methods were well tolerated. Early nausea was less common with oral medication.",2019,No differences were found in NRS pain scores or satisfaction between the groups except at 24 h pain when coughing; there was a statistically significant difference favoring the IV PCA group (p = 0.006).,"['postoperative analgesia after cesarean section', 'pain relief after cesarean section', 'University Hospital between February 2015 and June 2017', 'Altogether 270 CS patients']","['oxycodone PCA', 'oral oxycodone', 'oxycodone', 'postoperative oxycodone pain relief by IV PCA', 'oxycodone given intravenously using a patient-controlled analgesia (PCA) infusion device']","['vomiting', 'Pain control and satisfaction with pain treatment', 'numeric rating scale (NRS', 'Satisfaction with pain treatment', 'Early nausea', 'equianalgesic dose of oxycodone', 'postoperative recovery', 'pain control and satisfaction with pain relief', 'tolerated', 'nausea', 'gastrointestinal symptoms and postsurgical recovery', 'NRS pain scores or satisfaction']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",270.0,0.0949123,No differences were found in NRS pain scores or satisfaction between the groups except at 24 h pain when coughing; there was a statistically significant difference favoring the IV PCA group (p = 0.006).,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Mäkelä', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital, PL 2000, 33521, Tampere, Finland. katja.makela@pshp.fi.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Palomäki', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital, PL 2000, 33521, Tampere, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Pokkinen', 'Affiliation': 'Department of Anesthesia, Tampere University Hospital, PL 2000, 33521, Tampere, Finland.'}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': 'Department of Anesthesia, Tampere University Hospital, PL 2000, 33521, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': 'Research, Development and Innovation Centre, Tampere University Hospital, PL 2000, 33521, Tampere, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Uotila', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital, PL 2000, 33521, Tampere, Finland.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05260-3']
1279,31298632,Effects of E-cigarette Advertising Message Form and Cues on Cessation Intention: An Exploratory Study.,"A common message in e-cigarette advertising is that e-cigarettes can be used anywhere. E-cigarette advertisements often express this message implicitly (e.g., ""Whenever, wherever"") alongside images of e-cigarettes that physically resemble combustible cigarettes. These implicit messages and ""cigalike"" images may cross-cue combustible cigarette smoking cognitions and behavior. This exploratory study was a 2 (message form: implicit or explicit e-cigarette use anywhere message) by 2 (presence or absence of e-cigarette cue) experiment with U.S. adult smokers (n = 2,201). Participants were randomized to view e-cigarette advertisements that varied by study condition. Three combustible cigarette outcomes were investigated: smoking cessation intention, smoking urges, and immediate smoking behavior. Mediation analysis was also performed to investigate mechanisms of the message form effect through descriptive and normative beliefs about smoking. Compared to its explicit counterpart, the implicit e-cigarette use anywhere message evoked greater smoking urges. Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention. There was no evidence of e-cigarette cue or message form × cue interaction effects. Implicit e-cigarette use anywhere messages may create a predisposition towards smoking compared to their explicitly written counterparts, but whether this effect undermines cessation deserves further attention.",2019,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.",[],['E-cigarette Advertising Message Form and Cues'],"['smoking cessation intention, smoking urges, and immediate smoking behavior', 'Cessation Intention']",[],"[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",,0.012925,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jo', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'b School of Media and Journalism, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1639857']
1280,31809358,Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.,"BACKGROUND


Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety.
SETTING


Two high-volume facilities providing MC near Harare, Zimbabwe.
METHODS


A prospective, unblinded, noninferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n = 362) responded to a daily text with in-person follow-up only if desired or an adverse event (AE) was suspected. The control group (n = 359) received routine in-person visits. All men were asked to return on postoperative day 14 for review. AEs at ≤day 14 visit and the number of in-person visits were compared between the groups.
RESULTS


Cumulative AEs were identified in 0.84% [95% confidence interval (CI): 0.28 to 2.43] among routine care men as compared with 1.88% (95% CI: 0.86 to 4.03) of 2wT participants. Noninferiority cannot be ruled out (95% CI: -∞ to +2.72); however, AE rates did not differ between the groups (P = 0.32). 2wT men attended an average of 0.30 visits as compared with 1.69 visits among routine care men, a significant reduction (P < 0.001).
CONCLUSIONS


Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up.",2020,"Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment.","['722 adult MC clients with cell phones randomized 1:1', '2wT clients (n = 362', ""Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program"", '2wT']",['routine in-person visits'],"['Provider Workload', 'AE rates', 'number of in-person visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",722.0,0.139752,"Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment.","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Patricia T', 'Initials': 'PT', 'LastName': 'Gundidza', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002198']
1281,31969683,Lower Systolic Blood Pressure in Normotensive Subjects is Related to Better Autonomic Recovery Following Exercise.,"Blood pressure (BP) is a cardiovascular parameter applied to detect cardiovascular risk. Recently, the pre-hypertension state has received greater consideration for prevention strategies. We evaluated autonomic and cardiorespiratory recovery following aerobic exercise in normotensive individuals with different systolic BP (SBP) values. We investigated 30 healthy men aged 18 to 30 years divided into groups according to systolic BP (SBP): G1 (n = 16), resting SBP <110 mmHg and G2 (n = 14), resting SBP between 120-110 mmHg. The groups endured 15 minutes seated at rest, followed by a submaximal aerobic exercise on a treadmill and then remaining seated for 60 minutes also at rest, during recovery from the exercise. Cardiorespiratory parameters and heart rate (HR) variability (HRV) (rMSSD, SD1, HF [ms 2 ]) were evaluated before and during recovery from exercise. G2 displayed slower return of SBP, rMSSD and SD1 HRV indices during recovery from exercise compared to G1. In conclusion, normotensive subjects with higher resting SBP (110 to 120 mmHg) offered delayed autonomic recovery following moderate exercise. We suggest that this group may be less physiologically optimized leading to cardiac risks.",2020,"G2 displayed slower return of SBP, rMSSD and SD1 HRV indices during recovery from exercise compared to G1.","['Normotensive Subjects', 'normotensive individuals with different systolic BP (SBP) values', 'normotensive subjects with higher resting SBP (110 to 120\u2009mmHg', '30 healthy men aged 18 to 30 years divided into groups according to systolic BP (SBP): G1 (n\u2009=\u200916), resting SBP <110\u2009mmHg and G2 (n\u2009=\u200914), resting SBP between 120-110\u2009mmHg']","['aerobic exercise', 'submaximal aerobic exercise']","['return of SBP, rMSSD and SD1 HRV indices', 'Cardiorespiratory parameters and heart rate (HR) variability (HRV) (rMSSD, SD1, HF', 'Blood pressure (BP', 'delayed autonomic recovery', 'Autonomic Recovery', 'Systolic Blood Pressure']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",30.0,0.0165697,"G2 displayed slower return of SBP, rMSSD and SD1 HRV indices during recovery from exercise compared to G1.","[{'ForeName': 'Letícia Santana', 'Initials': 'LS', 'LastName': 'de Oliveira', 'Affiliation': 'Autonomic Nervous System Center, Post-Graduate Program in Physical Therapy, São Paulo State University, UNESP, Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Anne Michelli G G', 'Initials': 'AMGG', 'LastName': 'Fontes', 'Affiliation': 'Autonomic Nervous System Center, Post-Graduate Program in Physical Therapy, São Paulo State University, UNESP, Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Ana Laura Ricci', 'Initials': 'ALR', 'LastName': 'Vitor', 'Affiliation': 'Autonomic Nervous System Center, Post-Graduate Program in Physical Therapy, São Paulo State University, UNESP, Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Franciele M', 'Initials': 'FM', 'LastName': 'Vanderlei', 'Affiliation': 'Autonomic Nervous System Center, Post-Graduate Program in Physical Therapy, São Paulo State University, UNESP, Presidente Prudente, SP, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Cardiorespiratory Research Group, Department of Biological and Medical Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Headington Campus, Gipsy Lane, Oxford, OX3 0BP, United Kingdom.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center, Post-Graduate Program in Physical Therapy, São Paulo State University, UNESP, Presidente Prudente, SP, Brazil. vitor.valenti@unesp.br.'}]",Scientific reports,['10.1038/s41598-020-58031-5']
1282,32495698,Feasibility of collection and analysis of microbiome data in a longitudinal randomized trial of community gardening.,"Aim:  We explored the feasibility of collecting and analyzing human microbiome data in a longitudinal randomized controlled trial of community gardening.  Methods & materials:  Participants were randomly assigned to gardening (N = 8) or control (N = 8). Participants provided stool, mouth, hand and forehead microbiome samples at six timepoints. Analyses combined mixed models with Qiita output.  Results:  Participant satisfaction was high, with 75% of participants completing evaluations. While no microbial effects were statistically significant due to small sample size, the analysis pipeline utility was tested.  Conclusion:  Longitudinal collection and analysis of microbiome data in a community gardening randomized controlled trial is feasible. The analysis pipeline will be useful in larger studies for assessment of the pathway between microbiota, gardening and health outcomes.",2020,"Participant satisfaction was high, with 75% of participants completing evaluations.",[],[],['Participant satisfaction'],[],[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.17883,"Participant satisfaction was high, with 75% of participants completing evaluations.","[{'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain.'}, {'ForeName': 'Kylie K', 'Initials': 'KK', 'LastName': 'Harrall', 'Affiliation': 'Lifecourse Epidemiology of Adiposity and Diabetes Center, Colorado School of Public Health, University of Colorado Denver, Aurora, CO 800455, USA.'}, {'ForeName': 'Alyssa W', 'Initials': 'AW', 'LastName': 'Beavers', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, East Lansing, MI 488246, USA.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Glueck', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 800457, USA.'}, {'ForeName': 'Maggie A', 'Initials': 'MA', 'LastName': 'Stanislawski', 'Affiliation': 'Department of Epidemiology, University of Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 800458, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Alaimo', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, East Lansing, MI 488246, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Villalobos', 'Affiliation': 'Environmental Studies, University of Colorado Boulder, Boulder, CO 488246, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hebert', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Colombia, SC 8030310, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Dexter', 'Affiliation': 'Department of Endocrinology, University of Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 2920811, USA.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health & Exercise Science, Colorado State University, CO 8004512, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Litt', 'Affiliation': 'ISGlobal, Barcelona, Spain.'}]",Future microbiology,['10.2217/fmb-2019-0195']
1283,30670760,Randomised in situ clinical trial investigating self-assembling peptide matrix P11-4 in the prevention of artificial caries lesions.,"The aim was to investigate the ability of self-assembling Peptide P11-4 Matrix (SAPM) to remineralize artificial initial caries lesions compared to the use of fluoride varnish. Volunteers were recruited for this randomised, cross-over in situ trial. Bovine specimens, half including orthodontic brackets, were recessed on the buccal aspects of mandibular appliances. Specimens included internal sound enamel control, a demineralised control and a part exposed during the in situ phase. Each phase lasted four weeks, followed by a one-week washout. Treatment groups were: A: negative control, no treatment,B: positive control, 22,600 ppm fluoride varnish,C: test group, 1,000 ppm SAPM. Laser fluorescence values (LF) were measured before/after demineralisation, and after the in situ period. Micro-CT analysis was used to assess mineral changes within the specimens after the in situ phase. In specimens without brackets, ΔLF values after in situ phase were: A: +5.28, B: +0.85, C: -2.89. Corresponding ΔLF for specimens with brackets were: A: +5.77, B: +1.30, C: -3.15. LF-values between groups significantly differed from each other (p < 0.0001) after the in situ phase. Micro-CT analysis yielded no significant difference among groups for specimens without brackets. For specimens with brackets, the test group showed significantly more remineralisation than the negative (p = 0.01) and positive control (p = 0.003). Within the limitations of the study, SAPM showed prevention of caries and remineralisation of enamel around orthodontic brackets.",2019,"For specimens with brackets, the test group showed significantly more remineralisation than the negative (p = 0.01) and positive control (p = 0.003).",['artificial caries lesions'],"['self-assembling peptide matrix P11-4', 'fluoride varnish', 'self-assembling Peptide P11-4 Matrix (SAPM', 'negative control, no treatment,B: positive control, 22,600 ppm fluoride varnish,C: test group, 1,000 ppm SAPM']","['LF-values', 'Laser fluorescence values (LF', 'remineralisation']","[{'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0673066', 'cui_str': 'P11 (CBL)'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}]",,0.0450252,"For specimens with brackets, the test group showed significantly more remineralisation than the negative (p = 0.01) and positive control (p = 0.003).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jablonski-Momeni', 'Affiliation': 'Philipps University of Marburg, Dental School, Department of Orthodontics, Marburg, Germany. momeni@staff.uni-marburg.de.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Korbmacher-Steiner', 'Affiliation': 'Philipps University of Marburg, Dental School, Department of Orthodontics, Marburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heinzel-Gutenbrunner', 'Affiliation': 'MH Statistics Consulting, Marburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jablonski', 'Affiliation': 'Dental Practice, Lollar, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jaquet', 'Affiliation': 'Vrije Universiteit Brussel, Department of Oral Health Sciences ORHE, Faculty of Medicine and Pharmacy, Brussel, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bottenberg', 'Affiliation': 'Vrije Universiteit Brussel, Department of Oral Health Sciences ORHE, Faculty of Medicine and Pharmacy, Brussel, Belgium.'}]",Scientific reports,['10.1038/s41598-018-36536-4']
1284,32199152,"Interplay between PCI access site, anticoagulant agent, and bleeding: Insights from the REGULATE-PCI randomized trial.",,2020,,[],[],[],[],[],[],,0.0367254,,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Zelenkofske', 'Affiliation': 'Regado Biosciences, Basking Ridge, NJ, USA.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY, USA.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA. Electronic address: thomas.povsic@duke.edu.'}]",American heart journal,['10.1016/j.ahj.2020.02.013']
1285,32220393,Incorporating Hourly Rounding to Increase Emergency Department Patient Satisfaction: A Quality Improvement Approach.,"PROBLEM


Patient satisfaction is an important factor that influences the perceived quality of care delivered. In an effort to meet patient expectations, a process improvement initiative involving hourly rounding was implemented to improve low patient satisfaction scores.
METHODS


This project took place over 23 months and consisted of 4 phases (baseline, intervention I, break, and intervention II). During the intervention phases, self-reported hourly rounding was tracked on a daily basis. Compliance with rounding and patient satisfaction results were provided to staff during unit meetings and were displayed on a visual tracker board. Weekly 5-minute customer service training was provided to all staff. During the baseline and break phases, hourly rounding was not tracked. However, patient satisfaction data were still collected through the Interactive Customer Evaluation system. Three variables were measured using a 5-point Likert scale: overall patient satisfaction, patient perception of staff attitude, and whether the health care team answered all patient questions/concerns.
RESULTS


Hourly rounding compliance was 39% during intervention I and 51% during intervention II. Approximately 0.01% of patients submitted satisfaction data. From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
DISCUSSION


There is a positive relationship between hourly rounding and patient satisfaction scores. Despite low compliance with hourly rounding, patient satisfaction increased for all 3 variables measured. To achieve a change in culture with hourly rounding compliance, nurse managers must consistently monitor staff compliance with hourly rounding.",2020,"From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
",[],[],"['perception of staff attitude', 'overall patient satisfaction', '5-point Likert scale: overall patient satisfaction, patient perception of staff attitude, and whether the health care team answered all patient questions/concerns', 'patient satisfaction']",[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038122', 'cui_str': 'Staff Attitude'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}]",3.0,0.0368272,"From baseline to conclusion of intervention II, overall patient satisfaction increased from 52% to 73%; perception of staff attitude increased from 70% to 84%; and whether the health care team answered all patient questions/concerns increased from 63% to 81%.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Brosinski', 'Affiliation': ''}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Riddell', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2019.08.004']
1286,32193166,Add a comment … how fitspiration and body positive captions attached to social media images influence the mood and body esteem of young female Instagram users.,"Social media content can negatively influence body esteem in young women by reinforcing beliefs that to be considered attractive, people must look a certain way. The current study examines how text associated with attractive social media images impacts on female users' mood and feelings about their own body. Female participants (N = 109) aged between 18 and 25 years were randomly allocated to one of three conditions in which they viewed the same fitspiration-style images from Instagram. However, the captions associated with each image were experimentally manipulated to reflect either a fitspiration, body positive, or neutral theme. Images associated with fitspiration captions encouraging observers to improve their personal fitness led to increased negative mood. When body-positive captions encouraging the self-acceptance of appearance or highlighting the unrealistic nature of social media content were viewed with the same images, no increase in negative affect was observed, and participants reported greater body esteem post exposure. The findings provide partial support for the idea that body positive comments accompanying images on Instagram may have some protective value for female body esteem. Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.",2020,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","['Female participants (N = 109) aged between 18 and 25 years', 'young female Instagram users', ""female users' mood and feelings about their own body"", 'young women']",[],"['body esteem', 'mood and body esteem']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}]",109.0,0.0163805,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","[{'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Bryony.Davies@port.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Mark.Turner@port.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Udell', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Julie.Udell@port.ac.uk.'}]",Body image,['10.1016/j.bodyim.2020.02.009']
1287,31820012,"Peer review: single-blind, double-blind, or all the way-blind?","A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding. Ideally, peer review is impartial. Among the many models of peer review, the single blind is currently the most adopted model in scientific journals. The double-blind model has been claimed to decrease bias, despite some difficulty in implementation.",2020,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,[],[],[],[],[],[],,0.145548,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bazi', 'Affiliation': 'American University of Beirut, Beirut, Lebanon. tb14@aub.edu.lb.'}]",International urogynecology journal,['10.1007/s00192-019-04187-2']
1288,32205155,Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2).,"AIMS


The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.
METHODS


Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.
DISCUSSION


The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation.",2020,"Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE).",[],[],"['inter-rater reliability', 'modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE', 'neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE']",[],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.0725806,"Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE).","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden. Electronic address: gisela.lilja@med.lu.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Helsingborg, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden - Forum South, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Blennow Nordstrom', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Cardiology, Lund, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Malmö, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Heimburg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Copenhagen, Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Department of Cardiology, Holbæk Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Levin', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences, Research and Education, Lund, Sweden.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'Cochin University Hospital (APHP) and Paris Descartes University, Paris, France.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Helbok', 'Affiliation': 'Department of Neurology, Neurological Intensive Care Unit, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hovdenes', 'Affiliation': 'Department of Anesthesiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Leithner', 'Affiliation': 'Department of Neurology, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Matt P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, CHUV, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy; San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Bankstown Hospital, South Western Sydney Local Health District, Sydney, Australia; Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Erasme Hospital, Université Libre de Bruxelles, Department of Intensive Care, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Siranec', 'Affiliation': 'Department of Medicine - Department of Cardiovascular Medicine, Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden.'}]",Resuscitation,['10.1016/j.resuscitation.2020.03.004']
1289,31411351,Effect of different fraction of inspired oxygen on development of atelectasis in mechanically ventilated children: A randomized controlled trial.,"BACKGROUND


The use of high fraction of inspired oxygen (F I  O 2  ) can cause direct pulmonary toxicity and pulmonary complications. The purpose of this study was to evaluate the effect of different F I  O 2  on development of intraoperative atelectasis in mechanically ventilated children using lung ultrasound.
METHODS


In this randomized controlled, patient- and sonographer-blinded trial, 86 children (≤6 years) undergoing noncardiac surgery were allocated into a low (n = 43) or high (n = 43) F I  O 2  group. The low F I  O 2  group consistently received 30% air-oxygen mixture during preoxygenation, ultrasound-guided recruitment maneuver, and mechanical ventilation. The high F I  O 2  group received 100% oxygen during preoxygenation and ultrasound-guided recruitment maneuver and 60% air-oxygen mixture during mechanical ventilation. Positive end-expiratory pressure of 5 cm H 2  O was applied in both groups. Lung ultrasound was performed one minute after the start of mechanical ventilation and at the end of surgery in both groups. Primary outcome was significant atelectasis incidence (consolidation score of ≥2 in any region) on the postoperative lung ultrasound. Secondary outcomes included significant atelectasis incidence on the preoperative lung ultrasound, incidences of intra- and postoperative desaturation, and incidences of postoperative fever and postoperative pulmonary complications.
RESULTS


Significant atelectasis incidence on the postoperative lung ultrasound was similar between the low and high F I  O 2  groups (28% vs 37%; Pearson chi-square value = 0.847; P = .357; OR 1.531; 95% CI 0.617-3.800). Significant atelectasis incidence on the preoperative lung ultrasound was also similar between the groups (12% vs 9%; Pearson chi-square value = 0.124; P = .725; OR 0.779; 95% CI 0.194-3.125). There were no statistically significant differences in the other secondary outcomes.
CONCLUSIONS


F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.",2019,F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.,"['mechanically ventilated children', 'mechanically ventilated children using lung ultrasound', '86 children (≤6\xa0years) undergoing noncardiac surgery were allocated into a low (n\xa0=\xa043) or high (n\xa0=\xa043']","['30% air-oxygen mixture during preoxygenation, ultrasound-guided recruitment maneuver, and mechanical ventilation', 'F I  O 2', 'fraction of inspired oxygen', '100% oxygen during preoxygenation and ultrasound-guided recruitment maneuver and 60% air-oxygen mixture during mechanical ventilation']","['atelectasis formation', 'significant atelectasis incidence on the preoperative lung ultrasound, incidences of intra- and postoperative desaturation, and incidences of postoperative fever and postoperative pulmonary complications', 'atelectasis incidence (consolidation score of ≥2 in any region) on the postoperative lung ultrasound', 'Positive end-expiratory pressure', 'preoperative lung ultrasound', 'postoperative lung ultrasound']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0004144', 'cui_str': 'Lung Collapse'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}]",86.0,0.180537,F I  O 2  did not affect significant atelectasis formation in mechanically ventilated children who received ultrasound-guided recruitment maneuver and positive end-expiratory pressure.,"[{'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Seoul National University College of Medicine, Seoul, Korea.'}]",Paediatric anaesthesia,['10.1111/pan.13718']
1290,32499503,Reconsolidation-based treatment for fear of public speaking: a systematic pilot study using propranolol.,"Pharmacological manipulation of memory reconsolidation opens up promising new avenues for anxiety disorder treatment. However, few studies have directly investigated reconsolidation-based approaches in subclinical or clinical populations, leaving optimal means of fear memory reactivation unknown. We conducted a systematic pilot study to assess whether a reconsolidation-based treatment could tackle public speaking anxiety in a subclinical sample (N = 60). As lab studies indicate that the duration of reactivation may be important for inducing reconsolidation, we investigated several speech lengths to help inform further translational efforts. Participants underwent a stress-inducing speech task composed of 3-min preparation, and from 0 to 9 min of public speaking, in 1-min increments. They then received either 40 mg of propranolol (n = 40) or placebo (n = 20), double-blind, allocated 4:2 for each speech duration. Participants performed a second speech 1 week post treatment, and were followed up with questionnaires 1- and 3 months later. Both self-reported speech distress and questionnaire measures of public speaking anxiety showed clear reductions following treatment. However, propranolol did not reliably outperform placebo, regardless of speech duration at treatment. Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test. These findings highlight the challenges facing the translation of laboratory research on memory reconsolidation into clinical interventions. Lack of explicit controls for factors beyond duration, such as 'prediction error', could explain these null findings, but positive results in clinical interventions are needed to demonstrate that taking such factors into account can deliver the promises of reconsolidation-based therapy.",2020,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"['fear of public speaking', 'tackle public speaking anxiety in a subclinical sample (N\u2009=\u200960']","['stress-inducing speech task composed of 3-min preparation, and from 0 to 9\u2009min of public speaking', 'propranolol', 'placebo']",['Physiological responses (heart rate and salivary cortisol'],"[{'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0293513,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands. j.w.b.elsey@uva.nl.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Filmer', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harriet R', 'Initials': 'HR', 'LastName': 'Galvin', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Kurath', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vossoughi', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linnea S', 'Initials': 'LS', 'LastName': 'Thomander', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zavodnik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Translational psychiatry,['10.1038/s41398-020-0857-z']
1291,30500960,Risk Factors and Maternal Morbidity Associated with Unintentional Hysterotomy Extension at the Time of Cesarean Delivery.,"OBJECTIVE


Our aim was to estimate the incidence of unintentional hysterotomy extension at the time of cesarean delivery and to identify associated risk factors and maternal morbidity.
STUDY DESIGN


We conducted a secondary analysis of a randomized controlled trial evaluating chlorhexidine-alcohol versus iodine-alcohol for skin antisepsis in women undergoing cesarean delivery. We included patients with a low transverse hysterotomy. The primary outcome was the incidence of unintentional hysterotomy extension. Logistic regression was performed to identify independent factors associated with hysterotomy extension. Maternal morbidity was compared between patients with and without extension.
RESULTS


Of 1,038 patients meeting the inclusion criteria, 71 (6.8%; 95% confidence interval [CI]: 5.4-8.5%) experienced a hysterotomy extension. Of several potential risk factors assessed, the second stage of labor was the only independent predictor of hysterotomy extension (adjusted odds ratio: 10.2; 95% CI: 2.6-39.8). Hysterotomy extension was associated with increased operative time (73 vs. 55.3 minutes;  p < 0.01), need for blood transfusion (relative risk: 5; 95% CI: 1.6-15.2), and rate of additional surgical injury (RR: 17; 95% CI: 6.9-41.8).
CONCLUSION


Hysterotomy extensions are not infrequent at the time of cesarean delivery and are associated with increased maternal morbidity. Cesarean delivery during the second stage of labor is the main independent risk factor for hysterotomy extension.",2019,"Hysterotomy extension was associated with increased operative time (73 vs. 55.3 minutes;  p < 0.01), need for blood transfusion (relative risk: 5; 95% CI: 1.6-15.2), and rate of additional surgical injury (RR: 17; 95% CI: 6.9-41.8).
","['women undergoing cesarean delivery', 'patients with a low transverse hysterotomy']",['chlorhexidine-alcohol versus iodine-alcohol'],"['incidence of unintentional hysterotomy extension', 'Risk Factors and Maternal Morbidity', 'operative time', 'maternal morbidity', 'rate of additional surgical injury', 'blood transfusion', 'Cesarean delivery', 'Maternal morbidity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0020711', 'cui_str': 'Hysterotomy'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0020711', 'cui_str': 'Hysterotomy'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0282208', 'cui_str': 'Injuries, Surgical'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]",1038.0,0.215135,"Hysterotomy extension was associated with increased operative time (73 vs. 55.3 minutes;  p < 0.01), need for blood transfusion (relative risk: 5; 95% CI: 1.6-15.2), and rate of additional surgical injury (RR: 17; 95% CI: 6.9-41.8).
","[{'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Bligard', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Durst', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Molly J', 'Initials': 'MJ', 'LastName': 'Stout', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}]",American journal of perinatology,['10.1055/s-0038-1676112']
1292,32494580,Immunogenicity and Reactogenicity of a Reduced Schedule of a 4-component Capsular Group B Meningococcal Vaccine: A Randomized Controlled Trial in Infants.,"Background


The 4-component capsular group B meningococcal vaccine (4CMenB) was licensed as a 4-dose infant schedule but introduced into the United Kingdom as 3 doses at 2, 4, and 12 months of age. We describe the immunogenicity and reactogenicity of the 2 + 1 schedule in infants.
Methods


Infants were randomized to receive 4CMenB with routine immunizations (test group) at 2, 4, and 12 months or 4CMenB alone at 6, 8, and 13 months of age (control group). Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses to factor H binding protein,  Neisseria  adhesion protein A,  Neisseria  heparin binding antigen, Porin A (PorA), and reactogenicity was measured.
Results


One hundred eighty-seven infants were randomized (test group: 94; control group: 93). In the test group, 4CMenB induced SBA titers above the putative protective threshold (1:4) after primary and booster doses in 97% of participants. Postbooster, the SBA GMT (72.1; 95% confidence interval [CI], 51.7-100.4) was numerically higher than the serum bactericidal antibody geometric mean titre (SBA GMT) determined post-primary vaccination (48.6; 95% CI, 37.2-63.4). After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster. Higher frequency of local and systemic adverse reactions was associated with 4CMenB.
Conclusions


A reduced schedule of 4CMenB was immunogenic and established immunological memory after booster.",2020,"After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster.","['Infants', 'One hundred eighty-seven infants', 'infants']","['4-component Capsular Group B Meningococcal Vaccine', '4CMenB with routine immunizations', '4-component capsular group B meningococcal vaccine (4CMenB']","['serum bactericidal antibody geometric mean titre (SBA GMT', 'SBA titers', 'immunogenicity and reactogenicity', 'Immunogenicity and Reactogenicity', 'Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses', 'memory B-cell responses', 'heparin binding antigen, Porin A (PorA), and reactogenicity', 'Higher frequency of local and systemic adverse reactions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1259712', 'cui_str': 'VDAC1 protein, human'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",187.0,0.113395,"After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Valente Pinto', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara Pellisso', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa143']
1293,32500209,Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.,"RATIONALE


Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD.
OBJECTIVES


To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD.
METHODS


Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire.
RESULTS


There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation.
CONCLUSIONS


PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.",2020,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"['participants with chronic PTSD', 'PTSD', 'Participants', 'Posttraumatic stress disorder (PTSD']","['open-label psychotherapy sessions with additional non-drug therapy sessions', '3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy', 'MDMA', 'MDMA-assisted psychotherapy']","['CAPS-IV scores', 'PTSD symptoms', 'CAPS-IV total severity scores', 'Clinician-Administered PTSD Scale for DSM IV']","[{'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.111743,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA. Ilsa@mapsbcorp.com.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Feduccia', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Emerson', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mithoefer', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05548-2']
1294,32500212,Subjective features of the psilocybin experience that may account for its self-administration by humans: a double-blind comparison of psilocybin and dextromethorphan.,"RATIONALE


Although both psilocybin and dextromethorphan (DXM) produce psychedelic-like subjective effects, rates of non-medical use of psilocybin are consistently greater than DXM.
OBJECTIVE


New data are presented from a study of psilocybin and DXM relevant to understanding the features of psilocybin subjective effects that may account for its higher rates of non-medical use.
METHODS


Single, acute oral doses of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.
RESULTS


High doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience. For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.
CONCLUSIONS


This analysis provides new information about domains of psilocybin subjective effects proposed to be related to its reinforcing effects (alternatively described as the ""motivation"" to use). Observed differences on these domains between psilocybin and DXM are consistent with the relative rates of non-medical use of psilocybin and DXM.",2020,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.",['20 healthy participants with histories of hallucinogen use'],"['psilocybin and dextromethorphan', 'psilocybin and dextromethorphan (DXM', 'psilocybin', 'DXM', 'placebo']","['visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience', 'participant ratings of peak overall drug effect strength', 'DXM']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004898', 'cui_str': 'Beauty'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]",20.0,0.150916,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Carbonaro', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA. rgriff@jhmi.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05533-9']
1295,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1296,32497906,Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.,"BACKGROUND


The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.
METHODS


This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.
RESULTS


Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).
CONCLUSIONS


In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.",2020,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"['patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock', 'patients undergoing', 'patients presenting with MI and multivessel disease complicated by CS']","['Radial versus femoral artery access', 'percutaneous coronary intervention (PCI', 'transradial artery access (TRA', 'percutaneous coronary artery intervention', 'transfemoral artery access (TFA']","['TRA and TFA', '30-day rate of death', '30-day rate of RRT', '30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke', 'death or RRT and death with TRA', '30-day rate of death or RRT', 'composite of death or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",673.0,0.38324,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'Statistician unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung and Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.014']
1297,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE


To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS).
DESIGN


Single centre double blind randomised controlled trial.
PARTICIPANTS


Women aged 18 years or over who had a CS.
INTERVENTIONS


All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group).
MAIN OUTCOME MEASURES


The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate.
RESULTS


324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups.
CONCLUSIONS


This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016']
1298,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE


Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA).
DESIGN


Randomized equivalence trial.
SETTING


University Hospital.
PATIENTS


Sixty patients undergoing primary THA.
INTERVENTIONS


Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h.
MEASUREMENTS


A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale.
MAIN RESULTS


No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048).
CONCLUSIONS


For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907']
1299,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND


Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities.
RESEARCH QUESTION


Is underwater gait training or overground gait training more effective in severe stroke patients?
METHODS


A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training.
RESULTS


Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm).
SIGNIFICANCE


In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking.
CLINICAL TRIAL REGISTRATION NUMBER


KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022']
1300,32506513,Use of metabolic syndrome severity to assess treatment with vitamin E and pioglitazone for non-alcoholic steatohepatitis.,"BACKGROUND AND AIM


Non-alcoholic steatohepatitis (NASH), which can lead to liver failure, requires liver biopsies to follow and is difficult to treat. Our goal was to assess metabolic syndrome (MetS) severity as a predictor of treatment success and a marker of response.
METHODS


We assessed data from the Pioglitazone, Vitamin E, or Placebo for NASH Study, in which individuals with biopsy-confirmed NASH were randomized to receive pioglitazone, vitamin E, or placebo for 96 weeks. We assessed associations of a sex-specific and race/ethnicity-specific MetS severity Z-score (MetS-Z) at baseline and 48 weeks with biopsy-determined endpoint of NASH resolution at 96 weeks.
RESULTS


Baseline MetS-Z was inversely associated with odds of NASH resolution (odds ratio [OR] per 1 SD of MetS-Z: 0.47, 95% confidence interval [CI] 0.28, 0.79). Decrease in MetS-Z during initial 48-week intervention was greatest for pioglitazone treatment (effect size: -0.31, 95% CI -0.15, -0.48) and for vitamin E tended toward being greater for those with versus without NASH resolution (-0.18 vs -0.05). Overall, 48-week change in MetS-Z was associated with NASH resolution (OR per 1-SD change: 0.53, 95% CI 0.33, 0.85), although this was attenuated in models that included transaminases, which remained linked to treatment success (OR by change-in-aspartate aminotransferase Z-score: 0.38, 95% CI 0.19, 0.76).
CONCLUSIONS


Individuals with more severe metabolic derangement at baseline were less likely to exhibit NASH resolution, suggesting that individuals may have a threshold of MetS severity beyond which successful treatment is unlikely. As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, although transaminases were a more consistent marker of NASH resolution.",2020,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","['Non-alcoholic Steatohepatitis', 'individuals with biopsy-confirmed NASH']","['pioglitazone', 'Vitamin-E and Pioglitazone', 'pioglitazone, vitamin-E or placebo', 'Pioglitazone, Vitamin-E or Placebo NASH Study (PIVENS']","['NASH resolution', 'MetS-Z', 'metabolic syndrome (MetS) severity']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.680429,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Mack', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology, University of Virginia, Charlottesville, Virginia, USA.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15131']
1301,32507357,A randomized open label efficacy clinical trial of oral guava leaf decoction in patients with acute infectious diarrhoea.,"BACKGROUND


Diarrhoea is amongst the first ten causes of death and its treatment faces an increased threat of drug resistance. Previous studies on the guava leaf decoction (GLD) revealed its suitability for use in infectious diarrhoea of unknown etiology.
OBJECTIVE


The objective of this trial was to establish efficacy, dose and safety of GLD prepared from the Indian Sardar variety in adults with acute infectious diarrhoea.
METHODS


The current trial was an open efficacy randomized 5-day, parallel group multi-arm interventional study. Amongst 137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males). Three doses of GLD (6-leaf, 10-leaf and 14-leaf) were compared with controls receiving oral rehydration solution. Decrease in stool frequency and improvement in consistency were the outcomes measured. The data was analyzed using ANOVA, Tukey's post-hoc test, Kruscal-Wallis test and Chi-Square test where applicable.
RESULTS


The trial showed that the 14-leaf (7.4 g) decoction was the most effective. Administration of the decoction, thrice daily helped the patients regain normalcy in 72 h as opposed to 120 h in controls. Safety of the intervention was reflected by normal levels of haemoglobin, liver and kidney parameters. No adverse events were reported.
CONCLUSION


The 14 leaves decoction was a safe treatment for adult acute uncomplicated diarrhoea of unknown etiology. Moreover due to component synergy and divergent mechanisms of action, it could possibly combat the generation of drug resistance and destruction of gut microbiota. Hence GLD has the potential for development as a first line treatment for diarrhoea.
TRIAL REGISTRATION


Trial was registered with Clinical Trials Registry - India (CTRI registration number: CTRI/2016/07/007095). The trial was retrospectively registered.",2020,"No adverse events were reported.
","['137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males', 'adults with acute infectious diarrhoea', 'patients with acute infectious diarrhoea']","['GLD', 'guava leaf decoction (GLD', 'decoction', 'oral guava leaf decoction']","['adverse events', 'normal levels of haemoglobin, liver and kidney parameters', 'stool frequency']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453279', 'cui_str': 'Guava'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",137.0,0.145841,"No adverse events were reported.
","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Birdi', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India. Electronic address: fmrmum@gmail.com.'}, {'ForeName': 'G Geetha', 'Initials': 'GG', 'LastName': 'Krishnan', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Kataria', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Gholkar', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Daswani', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.04.001']
1302,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND


Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma.
METHODS


GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment.
FINDINGS


In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths.
INTERPRETATION


Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial.
FUNDING


F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X']
1303,32505019,"Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.","BACKGROUND


Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (T sk ) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear.
AIM


To determine and compare occurrence and severity of IM, T sk  and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults.
METHODS


This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min.
RESULTS


All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). T sk  increased significantly with 1.0  °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506).
CONCLUSION


The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The T sk  increased significantly with both collars; however, no clinical difference in increase of T sk  between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.",2020,Total occurrence was higher in the Stifneck®-group,"['immobilized healthy adults', 'trauma patients with a suspicion of cervical cord injury patients', 'healthy volunteers', 'participants in supine position for 20\xa0min']","['immobilized', 'Collar-related pressure ulcers (CRPU']","['Indentation marks (IM), skin temperature (T sk ) and comfort', 'T sk', 'severe IM', 'Total occurrence', 'Indentation marks, skin temperature and comfort of two cervical collars']","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}]",,0.152707,Total occurrence was higher in the Stifneck®-group,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands. Electronic address: j.p.l.leenen@isala.nl.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ham', 'Affiliation': 'Emergency Department, University Medical Center Utrecht, University of Applied Science, Institute of Nursing Studies, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: w.h.ham@umcutrecht.nl.'}, {'ForeName': 'L P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Traumatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: l.p.h.leenen@umcutrecht.nl.'}]",International emergency nursing,['10.1016/j.ienj.2020.100878']
1304,32506579,A critical food system program in South Australia and the effects on consumer knowledge and attitudes.,"ISSUE ADDRESSED


This study investigated the effects of food system literacy on knowledge and attitudes of food consumers.
METHODS


A 2-week online course critically discussed the food system through three lenses of environmental sustainability, equity and health. Participants were randomly allocated into one Control and two Intervention groups (A & B). Data collection was by online questionnaire pre- and postintervention, addressing self-perceived food system knowledge, attitudes towards food purchasing behaviours, demographic characteristics and course evaluation. Differences in knowledge and attitude scores between Control and Intervention groups were assessed. Subjects were staff and students of Flinders University in South Australia.
RESULTS


Forty-seven participants completed the course. The completion rate was 71.2%. Knowledge about the food system improved significantly for both Intervention groups when compared to the Control group (P ≤ 0.001). Although attitudes towards food purchasing behaviours also improved significantly for both Intervention groups (P < 0.001 and P = 0.005 for Interventions A and B respectively), the improvements were not significant when compared to the Control group (P = 0.065 and P = 0.43 for Interventions A and B respectively). The online methodology received positive feedback from participants.
CONCLUSION


This 2-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption. SO WHAT?: It provides encouraging indications of the potential of food system literacy to empower citizens to make healthier as well as, more environmentally and socially sustainable food choices.",2020,This two-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption.,['Subjects were staff and students of XXXXXX University in XXXXXX'],['food system literacy'],"['completion rate', 'attitudes towards food purchasing behaviours', 'knowledge and attitude scores']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0230884,This two-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption.,"[{'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Rohrlach', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Coveney', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ward', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Booth', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, SA, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.370']
1305,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007']
1306,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377']
1307,32505932,Audiological assessment of neonatal hyperbilirubinemia.,"OBJECT


To evaluate the hearing of infants with history of neonatal hyperbilirubinemia using ABR.
METHODS


A prospective randomized study carried on 100 infants whose hearing was assessed by ABR. Infants were allocated into two groups; case group which involve 60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17 mg/dl and less than 30 mg/dl) and control group involve 40 healthy infants. Each group was divided into 3 groups based on their age i.e. ≤ 6 months, > 6-9 months &> 9-12 months. The evaluated variables were latency time & inter peak latency time.
RESULTS


The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave I did not show a significant difference between the two study groups (P > 0.05). The mean inter wave latencies I-III, I-V& III-V of ABR were significantly higher in the case group compared with the controls. There was a negative correlation between age and the studied variables.
CONCLUSION


Hyperbilirubinemia have an adverse effect on neonatal hearing which was reflected by ABR parameters of this study.",2020,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"['40 healthy infants', '60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17', 'neonatal hyperbilirubinemia', '100 infants whose hearing was assessed by ABR', 'hearing of infants with history of neonatal hyperbilirubinemia using ABR']",[],"['mean latencies of wave III&V of ABR', 'mean latencies of wave', 'mean inter wave latencies I-III, I-V& III-V of ABR', 'latency time & inter peak latency time']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",100.0,0.0141002,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"[{'ForeName': 'Yasser Mohammad', 'Initials': 'YM', 'LastName': 'Mandour', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghader_massoud@yahoo.com.'}, {'ForeName': 'Mohamed Aly', 'Initials': 'MA', 'LastName': 'El Sayed', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: drmohamedalyelsayed@yahoo.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El Sayed Morgan', 'Affiliation': 'Faculty of Medicine, Department of Audio Vestibular Medicine, Mansoura University, Mansoura Faculty of Medicine, Egypt. Electronic address: ashraf_morgan75@yahool.com.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Bassam', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghadeer_masoud@yahoo.com.'}, {'ForeName': 'Hamada', 'Initials': 'H', 'LastName': 'Fadl', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: fadl_hamada@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elrefae', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: refae_ahmed@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110126']
1308,32514590,Time to intra-arrest therapeutic hypothermia in out-of-hospital cardiac arrest patients and its association with neurologic outcome: a propensity matched sub-analysis of the PRINCESS trial.,"PURPOSE


To study the association between early initiation of intra-arrest therapeutic hypothermia and neurologic outcome in out-of-hospital cardiac arrest.
METHODS


A prespecified sub-analysis of the PRINCESS trial (NCT01400373) that randomized 677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival. Early cooling (intervention) was defined as intra-arrest cooling initiated < 20 min from collapse (i.e., ≤ median time to cooling in PRINCESS). Propensity score matching established comparable control patients. Primary outcome was favorable neurologic outcome, Cerebral Performance Category (CPC) 1-2 at 90 days. Complete recovery (CPC 1) was among secondary outcomes.
RESULTS


In total, 300 patients were analyzed and the proportion with CPC 1-2 at 90 days was 35/150 (23.3%) in the intervention group versus 24/150 (16%) in the control group, odds ratio (OR) 1.92, 95% confidence interval (CI) 0.95-3.85, p = .07. In patients with shockable rhythm, CPC 1-2 was 29/57 (50.9%) versus 17/57 (29.8%), OR 3.25, 95%, CI 1.06-9.97, p = .04. The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02. In patients with shockable rhythms, the proportion with CPC 1 was 27/57 (47.4%) versus 12/57 (21.1%), OR 5.33, 95% CI 1.55-18.3, p = .008.
CONCLUSIONS


In the whole study population, intra-arrest cooling initiated < 20 min from collapse compared to cooling initiated at hospital was not associated with improved favorable neurologic outcome. In the subgroup with shockable rhythms, early cooling was associated with improved favorable outcome and complete recovery.",2020,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.",[],"['677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival', 'Time to intra-arrest therapeutic hypothermia']","['favorable outcome and complete recovery', 'favorable neurologic outcome, Cerebral Performance Category (CPC', 'favorable neurologic outcome']",[],"[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",677.0,0.16917,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.","[{'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Awad', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jonsson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Anatolij', 'Initials': 'A', 'LastName': 'Truhlar', 'Affiliation': 'Emergency Medical Services of the Hradec Kralove Region, Hradec Králové, Czech Republic.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Ringh', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'The Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lance B', 'Initials': 'LB', 'LastName': 'Becker', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, 11030, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Svensson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden. per.nordberg@sll.se.'}]",Intensive care medicine,['10.1007/s00134-020-06024-3']
1309,32514607,"Effects of 3-month high-intensity interval training vs. moderate endurance training and 4-month follow-up on fat metabolism, cardiorespiratory function and mitochondrial respiration in obese adults.","PURPOSE


The purpose of this study was to investigate, in obese adults, changes in body composition, physical capacities, fat oxidation and ex vivo mitochondrial respiration induced by a 3-month either moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT); afterwards, the patients were followed for four months.
METHODS


Thirty-two patients (mean age 39 years; mean body mass index [BMI] 36 kg∙m -2 ) participated in this study attending ~ 34 sessions of training. At baseline (PRE), at the end of the program (POST) and after follow-up, body composition, peak O 2  uptake (V'O 2 peak) and fat oxidation rate were measured. Vastus lateralis biopsies for the evaluation of mitochondrial respiration were performed only at PRE and POST.
RESULTS


At POST, body mass (BM) and fat mass (FM) decreased (- 6 and - 14%, respectively, P < 0.05) in MICT and HIIT; V'O 2 peak increased in both groups (+ 6 and + 16%, respectively, P < 0.05). Maximal fat oxidation rate increased only after HIIT (P < 0.001). Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference. After follow-up, BM and FM were still lower (- 4 and - 20%, respectively, P < 0.050) compared with baseline in both groups. Only after HIIT, V'O 2 peak (+ 8%) and maximal fat oxidation rate were still higher (P < 0.05).
CONCLUSIONS


HIIT was more effective in improving and maintaining V'O 2 peak and fat oxidation. These results may be relevant for an appropriate prescription of training programs designed to optimize aerobic fitness in obese subjects.",2020,"Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference.","['obese subjects', 'Thirty-two patients (mean age 39\xa0years', 'obese adults']","['moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT', '3-month high-intensity interval training vs. moderate endurance training']","['body mass (BM) and fat mass (FM', 'fat metabolism, cardiorespiratory function and mitochondrial respiration', 'body composition, physical capacities, fat oxidation and ex vivo mitochondrial respiration', 'Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase', 'maximal fat oxidation rate', ""body composition, peak O 2  uptake (V'O 2 peak) and fat oxidation rate"", 'Maximal fat oxidation rate', 'BM and FM', ""effective in improving and maintaining V'O 2 peak and fat oxidation""]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",-2.0,0.024213,"Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference.","[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Vaccari', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy. vaccari.filippo@spes.uniud.it.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Passaro', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': ""D'Amuri"", 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Juana Maria', 'Initials': 'JM', 'LastName': 'Sanz', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Vece', 'Affiliation': 'Department of Medicine, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Capatti', 'Affiliation': 'Department of Medicine, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Magnesa', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Comelli', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Mavelli', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fiori', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bravo', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Avancini', 'Affiliation': 'Biomedical, Clinical and Experimental Sciences, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Parpinel', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lazzer', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04409-2']
1310,32516182,Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation: A randomised controlled trial.,,2020,,[],['Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation'],[],[],"[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",[],,0.165901,,"[{'ForeName': 'Chao-Kun', 'Initials': 'CK', 'LastName': 'Zeng', 'Affiliation': 'From the Department of Anaesthesiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, PR China (Z-CK, Z-GF, D-JH, L-DW).'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jin-He', 'Initials': 'JH', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'De-Wei', 'Initials': 'DW', 'LastName': 'Li', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001186']
1311,32516184,Acute pain after serratus anterior plane or thoracic paravertebral blocks for video-assisted thoracoscopic surgery: A randomised trial. Retraction.,,2020,,[],"['serratus anterior plane or thoracic paravertebral blocks', 'video-assisted thoracoscopic surgery']",['Acute pain'],[],"[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}]",,0.259756,,[],European journal of anaesthesiology,['10.1097/EJA.0000000000001258']
1312,32497260,Vitamin K supplementation for cystic fibrosis.,"BACKGROUND


Malabsorption and deficiency of fat-soluble vitamins K may occur in cystic fibrosis, a genetic disorder affecting multiple organs. Vitamin K is known to play an important role in both blood coagulation and bone formation, hence the role of supplementation of vitamin K in this category needs to be reviewed. This is an updated version of the review.
OBJECTIVES


To assess the effects of vitamin K supplementation in people with cystic fibrosis and to investigate the hypotheses that vitamin K will decrease deficiency-related coagulopathy, increase bone mineral density, decrease risk of fractures and improve quality of life in people with CF. Also to determine the optimal dose and route of administration of vitamin K for people with CF (for both routine and therapeutic use).
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 12 August 2019.
SELECTION CRITERIA


Randomised controlled trials of all preparations of vitamin K used as a supplement compared to either no supplementation (or placebo) at any dose or route and for any duration, in patients with cystic fibrosis.
DATA COLLECTION AND ANALYSIS


Two authors independently screened papers, extracted trial details and assessed their risk of bias. The quality of the evidence was assessed using the GRADE criteria.
MAIN RESULTS


Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included. One trial compared vitamin K to placebo, a second to no supplementation and the third compared two doses of vitamin K. No trial in either comparison reported our primary outcomes of coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events. Vitamin K versus control Two trials compared vitamin K to control, but data were not available for analysis. One 12-month trial (n = 38) compared 10 mg vitamin K daily or placebo in a parallel design and one trial (n = 18) was of cross-over design with no washout period and compared 5 mg vitamin K/week for four-weeks to no supplementation for four-weeks. Only the 12-month trial reported on the primary outcome of bone formation; we are very uncertain whether vitamin K supplementation has any effect on bone mineral density at the femoral hip or lumbar spine (very low-quality evidence). Both trials reported an increase in serum vitamin K levels and a decrease in undercarboxylated osteocalcin levels. The cross-over trial also reported that levels of proteins induced by vitamin K absence (PIVKA) showed a decrease and a return to normal following supplementation, but due to the very low-quality evidence we are not certain that this is due to the intervention. High-dose versus low-dose vitamin K One parallel trial (n = 14) compared 1 mg vitamin K/day to 5 mg vitamin K/day for four weeks. The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence). While the trial reported that serum vitamin K levels improved with supplementation, there was no difference between the high-dose and low-dose groups.
AUTHORS' CONCLUSIONS


There is very low-quality evidence of any effect of vitamin K in people with cystic fibrosis. While there is no evidence of harm, until better evidence is available the ongoing recommendations by national CF guidelines should be followed.",2020,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"['people with cystic fibrosis', 'cystic fibrosis', 'patients with cystic fibrosis', 'Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included', 'people with CF']","['Vitamin K', 'no supplementation (or placebo', 'vitamin K supplementation', 'vitamin K daily or placebo', 'vitamin K', 'Vitamin K supplementation', 'vitamin K to placebo']","['quality of life', 'bone mineral density', 'serum vitamin K levels', 'undercarboxylated osteocalcin levels', 'serum undercarboxylated osteocalcin or vitamin K levels', 'coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events', 'bone formation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443768', 'cui_str': 'Serum vitamin K measurement'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",70.0,0.547452,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"[{'ForeName': 'Vanitha A', 'Initials': 'VA', 'LastName': 'Jagannath', 'Affiliation': 'Department of Paediatrics, American Mission Hospital, Manama, Bahrain.'}, {'ForeName': 'Vidhu', 'Initials': 'V', 'LastName': 'Thaker', 'Affiliation': 'Division of Molecular Genetics and Department of Pediatrics, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Amy I', 'Initials': 'AI', 'LastName': 'Price', 'Affiliation': 'Research and Development, Empower 2 Go, Edmonton, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008482.pub6']
1313,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND


Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients.
MATERIALS AND METHODS


This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery.
RESULTS


The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05).
CONCLUSIONS


The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073']
1314,32506233,Does acute stress influence the Pavlovian-to-instrumental transfer effect? Implications for substance use disorders.,"RATIONAL


The ability of conditioned stimuli to affect instrumental responding is a robust finding from animal as well as human research and is assumed as a key factor regarding the development and maintenance of addictive behaviour.
OBJECTIVES


While it is well known that stress is an important factor for relapse after treatment, little is known about the impact of stress on conditioned substance-associated stimuli and their influence on instrumental responding.
METHODS


We administered in the present study a Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points in a token economy to light to moderate smokers who also indicated to like eating chocolate. After completion of the first two phases of the PIT paradigm (i.e. Pavlovian training and instrumental trainings), participants were randomly allocated to the socially evaluated cold pressor test or a control condition before the final phase of the PIT paradigm, the transfer phase, was administered.
RESULTS


The presentation of a smoking-related stimulus enhanced instrumental responding for a smoking-related reward (i.e. 'smoking-PIT' effect) and presentation of a chocolate-related stimulus for a chocolate-related reward (i.e. 'chocolate-PIT' effect) in participants aware of the experimental contingencies as indicated by expectancy ratings. However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
CONCLUSIONS


The established role of stress in addiction appears not to be driven by an augmenting effect on the ability of drug stimuli to promote drug-seeking.",2020,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
",[],"['PIT paradigm (i.e. Pavlovian training and instrumental trainings', 'socially evaluated cold pressor test', 'Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points']","['acute stress', 'tobacco choice']",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0217592,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany. sabine.steins-loeber@uni-bamberg.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lörsch', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van der Velde', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': 'Sussex Addiction Research and Intervention Centre, School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05534-8']
1315,32508043,Randomized trial of a hospice video educational tool for patients with advanced cancer and their caregivers.,"BACKGROUND


Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse.
METHODS


The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use.
RESULTS


Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P < .001). After the intervention, caregivers assigned to view the video were more likely to prefer hospice for their loved ones (94.4% vs 65.4%; P = .031), reported greater knowledge concerning hospice (9.7% vs 8.0%; P = .001), and were less likely to endorse that hospice is only about death (0.0% vs 23.1%; P = .066).
CONCLUSIONS


A hospice video did not significantly impact patients' preferences for hospice care. Patients with advanced cancer and their caregivers who were assigned to view the video were more informed regarding hospice and reported more favorable perceptions of hospice. Patients were more likely to use hospice and to have a longer hospice length of stay.",2020,Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010).,"['150 hospitalized patients with advanced cancer and their caregivers', 'Intervention participants (75 patients and 18 caregivers', 'patients with advanced cancer and their caregivers', 'Control participants (75 patients and 26 caregivers', 'Patients without a caregiver were eligible', 'Patients with advanced cancer and their caregivers', 'Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled']","['verbal description identical to the video narrative', '6-minute video depicting hospice', 'video educational tool versus a verbal description of hospice', 'hospice video educational tool']","['hospice length of stay', 'knowledge regarding hospice', 'patient preference for hospice', 'patient and/or caregiver knowledge and perceptions of hospice, and hospice use', 'knowledge concerning hospice', 'longer hospice length of stay']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",150.0,0.102002,Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010).,"[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Vanbenschoten', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Netana', 'Initials': 'N', 'LastName': 'Markovitz', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cashavelly', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lee Ann', 'Initials': 'LA', 'LastName': 'Tata', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Reynolds', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhatt', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fishman', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horick', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'University of Florida at Gainesville, Gainesville, Florida, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Cancer,['10.1002/cncr.32967']
1316,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
1317,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733']
1318,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143']
1319,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1320,32514794,"Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.","INTRODUCTION


Many commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes.
METHODS


This randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon.
RESULTS


Of the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient.
CONCLUSION


Nasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia.
TRIAL REGISTRATION


NCT03339453, ClinicalTrials.gov.",2020,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes']","['Insulin-Induced Hypoglycaemia', 'Glucagon preparations', 'Glucagon', 'Nasal glucagon', 'intramuscular glucagon (IMG', 'Nasal glucagon (NG']",['Hypoglycaemia (plasma glucose [PG'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.229767,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Suico', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': 'Endocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00845-7']
1321,32517390,Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial.,"BACKGROUND


Hemiplegic shoulder pain is one of the most common complications after stroke. Although there are many treatment strategies for this complication, sometimes very resistant cases are also seen.
OBJECTIVES


To evaluate the effect of suprascapular nerve pulsed radiofrequency (PRF) treatment for hemiplegic shoulder pain (HSP).
STUDY DESIGN


A prospective randomized-controlled trial.
SETTING


University hospital.
METHODS


This study included 30 patients with HSP following stroke. The patients were randomly assigned to receive PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB group, n = 15). The patients were randomized into 2 groups (n = 15 both). In addition, the patients received physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise (5 days per week for 3 weeks in a total of 15 sessions). Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM) were assessed at baseline, 1 month, and 3 months after the procedure.
RESULTS


Between the groups, comparison revealed that decrease in the VAS score was statistically significantly higher at the first (3.5 1.9 vs. 1.2 1.0) and third month (4.2 1.7 vs. 1.2 0.9) in the PRF group compared with the NB group (P < 0.01). The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
LIMITATION


There is a need for further studies with a longer follow-up period.
CONCLUSIONS


In light of these findings, the combination of PRF applied to the suprascapular nerve and physical therapy was superior to the combination of suprascapular NB and physical therapy.
KEY WORDS


Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve.",2020,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
","['30 patients with HSP following stroke', 'Hemiplegic Shoulder Pain', 'hemiplegic shoulder pain (HSP', 'University hospital']","['physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise', 'Suprascapular Nerve Pulsed Radiofrequency Treatment', 'suprascapular nerve pulsed radiofrequency (PRF', 'PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB']","['VAS score', 'GAS score', 'shoulder ROM', 'Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM', 'Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C3179076', 'cui_str': 'Pulsed Radio Frequency Treatment'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}]",30.0,0.0551158,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Alanbay', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kesan State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Berke', 'Initials': 'B', 'LastName': 'Aras', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kastamonu Rehabilitation Centre, Kastamonu, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Kesikburun', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Selvinaz', 'Initials': 'S', 'LastName': 'Kizilirmak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Gülhane Medical School, Gaziler Physical Therapy and Rehabilitation Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Yasar', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Arif Kenan', 'Initials': 'AK', 'LastName': 'Tan', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}]",Pain physician,[]
1322,32517391,Conservative Treatment Versus Ultrasound-Guided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial.,"BACKGROUND


Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient.
OBJECTIVES


The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy.
STUDY DESIGN


A prospective, randomized, sham-controlled study.
SETTING


Health Sciences University Training and Research Hospital in Turkey.
METHODS


Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) US-guided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period.
RESULTS


A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05).
LIMITATIONS


The limitation of the study was a short follow-up period.
CONCLUSIONS


US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment.
KEY WORDS


Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation.",2020,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"['Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study', 'A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period', 'patients with neuropathic pain symptoms', 'Meralgia Paresthetica', 'Health Sciences University Training and Research Hospital in Turkey']","['transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy', 'ultrasound (US)-guided LFCN injection', 'conventional TENS', 'US-guided injection group, (2) TENS group, and (3) sham TENS', 'Conservative Treatment Versus Ultrasound-Guided Injection', 'Meralgia paresthetica (MP', 'LFCN injection and TENS', 'Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation']","['VAS, SF-36, and PSQI scores', 'SF-36 and PSQI scores', 'mean changes in painDETECT and SWMt scores', 'Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0394678', 'cui_str': 'Conventional transcutaneous electrical nerve stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",3.0,0.0400468,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Kiliç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gebze Fatih State Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Feyza Ünlü', 'Initials': 'FÜ', 'LastName': 'Özkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Duygu Geler', 'Initials': 'DG', 'LastName': 'Külcü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Haydarpasa Numune Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Öztürk', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Akpinar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Aktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}]",Pain physician,[]
1323,32517392,Clinical Study of Spinal Cord Stimulation and Pulsed Radiofrequency for Management of Herpes Zoster-Related Pain Persisting Beyond Acute Phase in Elderly Patients.,"BACKGROUND


Postherpetic neuralgia (PHN) occurs in 9% to 34% of herpes zoster (HZ) patients, and the incidence of PHN is positively correlated with age. A number of patients suffer from poor therapeutic effects or intolerable side effects and need to accept minimally invasive analgesia.
OBJECTIVES


This study aimed to investigate the effects of spinal cord stimulation (SCS) and pulsed radiofrequency (PRF) on the treatment of elderly patients with HZ-related pain persisting beyond the acute phase.
STUDY DESIGN


A prospective, randomized-controlled trial.
SETTING


Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China).
METHODS


We selected 63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset. They were randomly divided into an SCS group and a PRF group. In the SCS group, the stimulus electrodes were placed in the affected spinal ganglion segment of the epidural space for 2 weeks. In the PRF group, the radiofrequency needle was percutaneously punctured in the affected dorsal root ganglion. The main outcome measures were the Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate. The secondary endpoint was defined as the use of analgesics and calcium channel antagonists.
RESULTS


The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) . The effective rate of pain management was in the range of 56.67% to 81.25%, and the complete pain relief rate ranged from 37% to 71%. The number of patients still using analgesics and calcium channel antagonists after operation were significantly less than those pre-operation (P < .001). Univariate and multivariate logistic regression analyses showed that the operation method, age, gender, and course of disease did not affect surgical efficacy.
LIMITATIONS


The main limitation of this study is that all the cases were from the same center.
CONCLUSION


It therefore can be concluded that SCS and PRF can effectively relieve PHN.
KEY WORDS


Spinal cord stimulation, pulsed radiofrequency, postherpetic neuralgia.",2020,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","['Elderly Patients', 'Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China', 'elderly patients with HZ-related pain persisting beyond the acute phase', '63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset']","['Spinal Cord Stimulation and Pulsed Radiofrequency', 'spinal cord stimulation (SCS) and pulsed radiofrequency (PRF', 'radiofrequency needle', 'SCS']","['Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate', 'complete pain relief rate', 'NRS-11 score', 'use of analgesics and calcium channel antagonists', 'effective rate of pain management']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",63.0,0.0296937,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","[{'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pain Medicine, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'Haining', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sima', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}]",Pain physician,[]
1324,32517393,Dexmedetomidine Added to Bupivacaine versus Bupivacaine in Transincisional Ultrasound-Guided Quadratus Lumborum Block in Open Renal Surgeries: A Randomized Trial.,"BACKGROUND


General anesthesia (GA) is the preferred anesthetic modality for open renal surgeries to ensure a patent airway while the patient is in the lateral decubitus position. However, these surgeries are usually accompanied by severe postoperative pain with increased requirements for multimodal pain management strategies. Regional blocks provide better postoperative pain control with less systemic opioid consumption.
OBJECTIVES


The aim of this study was to describe the ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB) as a new approach, and to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine alone for TiQLB in combination with GA regarding postoperative analgesia and adverse effects in open renal surgery.
STUDY DESIGN


A prospective, randomized, double-blind, controlled trial.
SETTING


Ain Shams University Hospitals.
METHODS


Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status I to II were enrolled in the study. They were randomly allocated into 2 equal groups: group dexmedetomidine-bupivacaine (DB) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine (B) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% only. The primary outcome was the total morphine consumption among both groups, whereas the secondary outcomes were the Visual Analog Scale (VAS) scores and the time to first analgesic requirement during the first 24 hours. Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression, were also recorded.
RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001). Time to first analgesic requirement was prolonged in patients in the DB group (18.6 ± 2.4 hours) in comparison to patients in the B group (7.3 ± 1.1 hours). Ten minutes after the block there was a significant reduction in mean blood pressure and heart rate in the DB group than in the B group. Regarding postoperative adverse effects, sedation scores were higher in the DB group than in the B group, postoperative nausea, vomiting, and shivering were significantly higher in the B group than in the DB group. Bradycardia was significantly more frequent among the DB group. Although nonsignificant, pruritus was more frequent in the B group than in the DB group. No cases of respiratory depression were reported in both groups.
LIMITATIONS


The used technique US-guided TiQLB could be performed in open renal surgeries only.
CONCLUSIONS


The new approach US-guided TiQLB was effective and easy to be performed. Adding dexmedetomidine to bupivacaine in TiQLB was associated with potent and prolonged postoperative analgesia with fewer postoperative adverse effects.
KEY WORDS


Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine.",2020,"RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","['Ain Shams University Hospitals', 'Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status', 'Open Renal Surgeries']","['Bupivacaine', 'bupivacaine', 'dexmedetomidine-bupivacaine (DB', 'combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine', 'Dexmedetomidine', 'General anesthesia (GA', 'ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB', 'dexmedetomidine', 'combined GA plus TiQLB']","['total morphine consumption and lower VAS scores', 'Bradycardia', 'Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression', 'Visual Analog Scale (VAS) scores and the time to first analgesic requirement', 'postoperative adverse effects, sedation scores', 'total morphine consumption', 'Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine', 'respiratory depression', 'Time to first analgesic requirement', 'postoperative nausea, vomiting, and shivering', 'mean blood pressure and heart rate', 'pruritus']","[{'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",80.0,0.0898718,"RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","[{'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Marwa A K', 'Initials': 'MAK', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Pain physician,[]
1325,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE


Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
METHODS


The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.
ETHICS AND DISSEMINATION


The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132']
1326,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE


Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty.
PATIENTS AND METHODS


Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device.
RESULTS


VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups.
CONCLUSIONS


Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983']
1327,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1328,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND


Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown.
RESEARCH QUESTION


To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces?
METHODS


Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position.
RESULTS


Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
SIGNIFICANCE


It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044']
1329,32524226,"Hypoxic training improves blood pressure, nitric oxide and hypoxia-inducible factor-1 alpha in hypertensive patients.","PURPOSE


To examine the effects of intermittent hypoxic breathing at rest (IHR) or during exercise (IHT) on blood pressure and nitric oxide metabolites (NOx) and hypoxia-inducible factor-1 alpha levels (HIF-1α) over a 6-week period.
METHODS


47 hypertensive patients were randomly allocated to three groups: hypertensive control (CON: n = 17; IHR: n = 15 and IHT: n = 15. The CON received no intervention; whereas, IH groups received eight events of hypoxia (F I O 2  0.14), and normoxia (F I O 2  0.21), 24-min hypoxia and 24-min normoxia, for 6 weeks. The baseline data were collected 2 days before the intervention; while, the post-test data were collected at days 2 and 28 after the 6-week intervention.
RESULTS


We observed a significant decrease of the SBP in both IH groups: IHR (- 12.0 ± 8.0 mmHg, p = 0.004 and - 9.9 ± 8.8 mmHg, p = 0.028, mean ± 95% CI) and IHT (- 13.0 ± 7.8 mmHg, p = 0.002 and - 10.0 ± 8.4 mmHg, p = 0.016) at days 2 and 28 post-intervention, respectively. Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001). At 2 days post-intervention, NOx and HIF-1α were negatively correlated with SBP in IHT.
CONCLUSION


IH programs may act as an alternative therapeutic strategy for hypertension patients probably through elevation of NOx and HIF-1α production.",2020,"Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001).","['hypertensive patients', 'hypertension patients', '47 hypertensive patients']","['Hypoxic training', 'intermittent hypoxic breathing at rest (IHR) or during exercise (IHT', 'hypertensive control (CON: n\u2009=\u200917; IHR: n\u2009=\u200915 and IHT: n\u2009=\u200915']","['blood pressure and nitric oxide metabolites (NOx) and hypoxia-inducible factor-1 alpha levels (HIF-1α', 'SBP', 'blood pressure, nitric oxide and hypoxia-inducible factor-1 alpha']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1528322', 'cui_str': 'HIF1A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",47.0,0.0282204,"Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001).","[{'ForeName': 'Nattha', 'Initials': 'N', 'LastName': 'Muangritdech', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hamlin', 'Affiliation': 'Department of Tourism, Sport and Society, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Kittisak', 'Initials': 'K', 'LastName': 'Sawanyawisuth', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Prajumwongs', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Wisutthida', 'Initials': 'W', 'LastName': 'Saengjan', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Preetiwat', 'Initials': 'P', 'LastName': 'Wonnabussapawich', 'Affiliation': 'Sport and Exercise Science Program, Faculty of Science and Technology, Nakhonratchasima Rajabhat University, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Nuttaset', 'Initials': 'N', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Apiwan', 'Initials': 'A', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. mapiwa@kku.ac.th.'}]",European journal of applied physiology,['10.1007/s00421-020-04410-9']
1330,32530550,Intralesional antigen immunotherapy for the treatment of plane warts: A comparative study.,"Intralesional immunotherapy by different antigens has shown promising efficacy and safety in the treatment of warts. However, the use of these antigens for the treatment of plane warts has been investigated in two studies only. To evaluate the efficacy and safety of three antigens; Measles Mumps, Rubella vaccine (MMR), Candida antigen, and purified protein derivative (PPD) in the treatment of multiple plane warts. The study included 120 patients who were randomly assigned to three groups, 40 patients in each group. Each agent was injected intralesionally at a dose of 0.1 mL into the largest wart at 2-week intervals until complete clearance or for a maximum of five sessions. Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group, and in 62.5% of the MMR group. No statistically significant difference in the therapeutic response was found between the three groups. Intralesional antigen immunotherapy seems to be a promising well-tolerated and effective therapeutic option for the treatment of multiple plane warts, with relatively higher efficacy of Candida antigen.",2020,"Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group and in 62.5% of the MMR group.","['multiple plane warts', '120 patients who were randomly assigned to three groups, 40 patients in each group', 'plane warts']","['Intralesional immunotherapy', 'Rubella vaccine (MMR), Candida antigen, and purified protein derivative (PPD', 'Intralesional antigen immunotherapy']","['efficacy and safety', 'therapeutic response', 'Complete clearance of warts']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]",120.0,0.0176779,"Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group and in 62.5% of the MMR group.","[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Fawzy', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Venereology, and Andrology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nofal', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Venereology, and Andrology, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Venereology, and Andrology, Zagazig University, Zagazig, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13807']
1331,32501595,Metformin monotherapy for adults with type 2 diabetes mellitus.,"BACKGROUND


Worldwide, there is an increasing incidence of type 2 diabetes mellitus (T2DM). Metformin is still the recommended first-line glucose-lowering drug for people with T2DM. Despite this, the effects of metformin on patient-important outcomes are still not clarified.
OBJECTIVES


To assess the effects of metformin monotherapy in adults with T2DM.
SEARCH METHODS


We based our search on a systematic report from the Agency for Healthcare Research and Quality, and topped-up the search in CENTRAL, MEDLINE, Embase, WHO ICTRP, and ClinicalTrials.gov. Additionally, we searched the reference lists of included trials and systematic reviews, as well as health technology assessment reports and medical agencies. The date of the last search for all databases was 2 December 2019, except Embase (searched up 28 April 2017).
SELECTION CRITERIA


We included randomised controlled trials (RCTs) with at least one year's duration comparing metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs in adults with T2DM.
DATA COLLECTION AND ANALYSIS


Two review authors read all abstracts and full-text articles/records, assessed risk of bias, and extracted outcome data independently. We resolved discrepancies by involvement of a third review author. For meta-analyses we used a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall certainty of the evidence by using the GRADE instrument.
MAIN RESULTS


We included 18 RCTs with multiple study arms (N = 10,680). The percentage of participants finishing the trials was approximately 58% in all groups. Treatment duration ranged from one to 10.7 years. We judged no trials to be at low risk of bias on all 'Risk of bias' domains. The main outcomes of interest were all-cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD). Two trials compared metformin (N = 370) with insulin (N = 454). Neither trial reported on all-cause mortality, SAE, CVM, NFMI, NFS or ESRD. One trial provided information on HRQoL but did not show a substantial difference between the interventions. Seven trials compared metformin with sulphonylureas. Four trials reported on all-cause mortality: in three trials no participant died, and in the remaining trial 31/1454 participants (2.1%) in the metformin group died compared with 31/1441 participants (2.2%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on SAE: in two trials no SAE occurred (186 participants); in the other trial 331/1454 participants (22.8%) in the metformin group experienced a SAE compared with 308/1441 participants (21.4%) in the sulphonylurea group (very low-certainty evidence). Two trials reported on CVM: in one trial no CVM was observed and in the other trial 4/1441 participants (0.3%) in the metformin group died of cardiovascular reasons compared with 8/1447 participants (0.6%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on NFMI: in two trials no NFMI occurred, and in the other trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 15/1441 participants (1.0%) in the sulphonylurea group (very low-certainty evidence). One trial reported no NFS occurred (very low-certainty evidence). No trial reported on HRQoL or ESRD. Seven trials compared metformin with thiazolidinediones (very low-certainty evidence for all outcomes). Five trials reported on all-cause mortality: in two trials no participant died; the overall RR was 0.88, 95% CI 0.55 to 1.39; P = 0.57; 5 trials; 4402 participants). Four trials reported on SAE, the RR was 0,95, 95% CI 0.84 to 1.09; P = 0.49; 3208 participants. Four trials reported on CVM, the RR was 0.71, 95% CI 0.21 to 2.39; P = 0.58; 3211 participants. Three trial reported on NFMI: in two trials no NFMI occurred and in one trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 25/1456 participants (1.7%) in the thiazolidinedione group. One trial reported no NFS occurred. No trial reported on HRQoL or ESRD. Three trials compared metformin with dipeptidyl peptidase-4 inhibitors (one trial each with saxagliptin, sitagliptin, vildagliptin with altogether 1977 participants). There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes). One trial compared metformin with a glucagon-like peptide-1 analogue (very low-certainty evidence for all reported outcomes). There was no substantial difference between the interventions for all-cause mortality, CVM, NFMI and NFS. One or more SAEs were reported in 16/268 (6.0%) of the participants allocated to metformin compared with 35/539 (6.5%) of the participants allocated to a glucagon-like peptide-1 analogue. HRQoL or ESRD were not reported. One trial compared metformin with meglitinide and two trials compared metformin with no intervention. No deaths or SAEs occurred (very low-certainty evidence) no other patient-important outcomes were reported. No trial compared metformin with placebo or a behaviour changing interventions. Four ongoing trials with 5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024. Furthermore, 24 trials with 2369 participants are awaiting assessment.
AUTHORS' CONCLUSIONS


There is no clear evidence whether metformin monotherapy compared with no intervention, behaviour changing interventions or other glucose-lowering drugs influences patient-important outcomes.",2020,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","['adults with type 2 diabetes mellitus', 'N = 370) with insulin (N = 454', '18 RCTs with multiple study arms (N = 10,680', 'people with T2DM', 'with altogether 1977 participants', '2369 participants are awaiting assessment', '5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024', 'adults with T2DM']","['metformin monotherapy', 'Metformin', 'SAE', 'metformin with placebo', 'sulphonylurea', 'Metformin monotherapy', 'saxagliptin, sitagliptin, vildagliptin', 'glucagon-like peptide-1 analogue', 'metformin', 'CVM', 'thiazolidinedione', 'NFMI', 'metformin with dipeptidyl peptidase-4 inhibitors', 'metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs', 'metformin with thiazolidinediones']","['cause mortality, SAE, CVM, NFMI and NFS', 'HRQoL or ESRD', 'cause mortality, SAE, CVM, NFMI, NFS or ESRD', 'deaths or SAEs', 'died of cardiovascular reasons', 'CVM', 'NFMI', 'cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD', 'cause mortality', 'overall RR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",370.0,0.173295,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Gnesin', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Department 7652, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anne Cathrine Baun', 'Initials': 'ACB', 'LastName': 'Thuesen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lise Katrine Aronsen', 'Initials': 'LKA', 'LastName': 'Kähler', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012906.pub2']
1332,32502050,Effect of video-guided educational intervention on school engagement of adolescent students with hearing impairment: Implications for health and physical education.,"BACKGROUND/OBJECTIVE


Hearing impaired students still face stigmatization and marginalization especially in inclusive classrooms in developing regions. This negatively impacts their school engagement. The present study aimed at ascertaining the effect of video-guided educational intervention on school engagement of hearing impaired students.
METHOD


Randomized controlled trial design was adopted for the present study. A total of 46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study. The students were randomly assigned to groups - intervention group and care-as-usual control group. A video-guided educational intervention package which consists of 13-minutes captioned video clips with school engagement themes served as the treatment intervention. Data were collected at 3 different times (pre-test, post-test and follow up) using School Engagement Scale created by Fredericks, Blumenfeld, Friedel and Paris (2005). Data were analyzed using independent sample t-test, paired sample t-test, Cohen d and Chi-square.
RESULTS


Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = -9.305, P < .001; Emotional: t(24) = -7.772, P < .001; Cognitive: t(24) = -7.330 P < .001) as well as total student engagement (t(24) = 12.022, P < .001, Δ = 5.362). Also, the students who took part in the video-guided educational intervention maintained improved school engagement at follow-up.
CONCLUSION


Video-guided educational intervention is an effective intervention for improving school engagement of hearing impaired adolescent students. Since acquiring relevant education is essential for leading a quality life especially among the special needs population, it was recommended that students with hearing impairment should be helped to acquire life skills through education by fostering their school engagement.",2020,"RESULTS


Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","['students with hearing impairment', 'hearing impaired adolescent students', '46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study', 'school engagement of hearing impaired students', 'adolescent students with hearing impairment']","[' intervention group and care-as-usual control group', 'video-guided educational intervention', 'Video-guided educational intervention']","['total student engagement', 'school engagement level', 'school engagement']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0308663,"RESULTS


Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Ngozi O', 'Initials': 'NO', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': 'Department of Sociology/Criminology and Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria.'}, {'ForeName': 'Chinedozie', 'Initials': 'C', 'LastName': 'Uwakwe', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Benedict C', 'Initials': 'BC', 'LastName': 'Eze', 'Affiliation': 'Department of Arts Education.'}]",Medicine,['10.1097/MD.0000000000020643']
1333,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995']
1334,32511981,"Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Resistance to approved inhibitors of KIT proto-oncogene, receptor tyrosine kinase (KIT), and platelet-derived growth factor receptor α (PDGFRA) is a clinical challenge for patients with advanced gastrointestinal stromal tumours. We compared the efficacy and safety of ripretinib, a switch-control tyrosine kinase inhibitor active against a broad spectrum of KIT and PDGFRA mutations, with placebo in patients with previously treated, advanced gastrointestinal stromal tumours.
METHODS


In this double-blind, randomised, placebo-controlled, phase 3 study, we enrolled adult patients in 29 specialised hospitals in 12 countries. We included patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Eligible patients were randomly assigned (2:1) to receive either oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo group). Randomisation was done via an interactive response system using randomly permuted block sizes of six and stratified according to number of previous therapies and ECOG performance status. Patients, investigators, research staff, and the sponsor study team were masked to a patient's treatment allocation until the blinded independent central review (BICR) showed progressive disease for the patient. The primary endpoint was progression-free survival, assessed by BICR. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of study drug. Patients randomly assigned to placebo were permitted to cross over to ripretinib 150 mg at the time of disease progression. The INVICTUS study is registered with ClinicalTrials.gov, number NCT03353753, and with WHO International Clinical Trials Registry Platform, number EUCTR2017-002446-76-ES; follow-up is ongoing.
FINDINGS


Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients were randomly assigned to receive either ripretinib (n=85) or placebo (n=44). At data cutoff (May 31, 2019), at a median follow-up of 6·3 months (IQR 3·2-8·2) in the ripretinib group and 1·6 months (1·1-2·7) in the placebo group, 51 patients in the ripretinib group and 37 in the placebo group had had progression-free survival events. In the double-blind period, median progression-free survival was 6·3 months (95% CI 4·6-6·9) with ripretinib compared with 1·0 months (0·9-1·7) with placebo (hazard ratio 0·15, 95% CI 0·09-0·25; p<0·0001). The most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events in the ripretinib group (n=85) included lipase increase (four [5%]), hypertension (three [4%]), fatigue (two [2%]), and hypophosphataemia (two (2%]); in the placebo group (n=43), the most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events were anaemia (three [7%]), fatigue (one [2%]), diarrhoea (one [2%]), decreased appetite (one [2%]), dehydration (one [2%]), hyperkalaemia (one [2%]), acute kidney injury (one [2%]), and pulmonary oedema (one [2%]). Treatment-related serious adverse events were reported in eight (9%) of 85 patients who received ripretinib and three (7%) of 43 patients who received placebo. Treatment-related deaths occurred in one patient in the placebo group (septic shock and pulmonary oedema) and one patient in the ripretinib group (cause of death unknown; the patient died during sleep).
INTERPRETATION


Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
FUNDING


Deciphera Pharmaceuticals.",2020,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","['enrolled adult patients in 29 specialised hospitals in 12 countries', 'patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments', 'Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients', 'patients with previously treated, advanced gastrointestinal stromal tumours', 'patients with advanced gastrointestinal stromal tumours (INVICTUS', 'patients with advanced gastrointestinal stromal tumours', 'Eligible patients']","['ripretinib', 'oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo', 'placebo']","['lipase increase', 'median progression-free survival', 'progression-free survival events', 'intention-to-treat population and safety', 'fatigue', 'hyperkalaemia', 'acute kidney injury', 'septic shock and pulmonary oedema', 'diarrhoea', 'dehydration', 'serious adverse events', 'pulmonary oedema', 'hypertension', 'deaths', 'decreased appetite', 'progression-free survival, assessed by BICR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.788248,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","[{'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France; Headquarters, Unicancer, Paris, France; LYRICAN, Lyon, France; Faculte Lyon Est, Université Claude Bernard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine, Portland VA Health Care System, Portland, OR, USA; OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology and Preventative Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, Essen, Germany; German Consortium for Translational Cancer Research (DKTK), Partner Site Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Leuven Cancer Institute and Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK; Division of Clinical Studies, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30168-6']
1335,32517389,"Intermediate Cervical Plexus Block in the Management of Persistent Postoperative Pain Post Carotid Endarterectomy: A Prospective, Randomized, Controlled, Clinical Trial.","BACKGROUND


The mechanisms of persistent postoperative pain (PPP) with neuropathic features after carotid endarterectomy (CEA) are multifaceted and are incompletely understood.
OBJECTIVES


The aim of this research was to assess whether the ultrasound-guided (USG) intermediate cervical plexus block (ICPB) could provide better control of PPP and neuropathic disturbances (NPDs) after CEA than the USG superficial cervical plexus block (SCPB).
STUDY DESIGN


Prospective, randomized, controlled, clinical trial.
SETTING


This clinical trial was conducted at the SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy).
METHODS


Patients who were scheduled for primary CEA were chosen. In the experimental group, the USG-ICPB was performed unilaterally, at the level of the third cervical vertebra. The needle was inserted into the deep lamina of the deep fascia of the neck, between the posterior border of the middle scalene muscle and the anterior border of the posterior scalene muscle. Three milliliters saline solution was injected into the opening of the deep lamina, and 20 mL 0.375% levobupivacaine was injected. In the control group, the anesthetic target was located at the inferior border of the sternocleidomastoid muscle at the level of the third cervical vertebra. The needle was superficially inserted below the skin, and 2 to 3 mL saline solution was injected into the opening of the superficial lamina of the deep fascia of the neck. A total of 20 mL 0.375% isobaric levobupivacaine was subsequently injected.The primary outcome measure was the proportion of patients with PPP on movement and at rest 3 months after surgery. The secondary outcome measures were NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption. Adverse effects were also recorded.
RESULTS


A total of 98 consecutive patients were enrolled and randomized to receive either a USG-SCPB (control group, n = 49) or a USG-ICPB (experimental group, n = 49). The sensory blockade was longer in the experimental group. Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063). The proportions of patients with NPDs were not different between the groups, whereas the sizes of the areas of interest (cm2) were significantly different.
LIMITATIONS


A limitation of this study is that we assessed NPDs for only 3 months using the von Frey hair test and the Lindblom test without additional instrumental techniques. Additionally, there are many risk factors for NPDs after CEA. For this reason, another limitation of this research is that we neglected to consider the relationship between the choice of anesthetic block and the presence of these risk factors.
CONCLUSIONS


The USG-ICPB provided long-lasting analgesia during the postoperative period and might mitigate the development of NPDs, thereby decreasing the analgesic drug requirement.
KEY WORDS


Carotid endarterectomy, intermediate cervical plexus block, myofascial planes of neck, neuropathic disturbances, persistent postoperative pain, superficial cervical plexus blocks, ultrasound guidance, vascular disease.",2020,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","['98 consecutive patients', 'Patients who were scheduled for primary CEA were chosen', ""SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy""]","['Intermediate Cervical Plexus Block', 'carotid endarterectomy (CEA', 'levobupivacaine', 'ultrasound-guided (USG) intermediate cervical plexus block (ICPB', 'isobaric levobupivacaine', 'USG-SCPB (control group, n = 49) or a USG-ICPB']","['proportions of patients with pain', 'proportion of patients with PPP on movement', 'NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption', 'Adverse effects', 'sensory blockade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0068515', 'cui_str': 'neodymium pyrocatechin disulfonate'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]",98.0,0.0787637,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Petrucci', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Cofini', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pizzi', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Coletta', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Angelo Geremia', 'Initials': 'AG', 'LastName': 'Blasetti', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Necozione', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Fusco', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Marinangeli', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}]",Pain physician,[]
1336,32520418,Grapefruit juice enhances the systolic blood pressure-lowering effects of dietary nitrate-containing beetroot juice.,"AIMS


Dietary nitrate from sources such as beetroot juice lowers blood pressure (BP) via the nitrate-nitrite-nitric oxide (NO) pathway. However, NO and nitrite are inactivated via reoxidation to nitrate, potentially limiting their activity. Cytochrome P450-3A4 inhibition with troleandomycin prevents nitrite re-oxidation to nitrate in rodent liver. Grapefruit juice contains the CYP3A4 inhibitor furanocoumarin. We therefore hypothesized that grapefruit juice would enhance BP-lowering with beetroot juice by maintaining circulating [nitrite].
METHODS


We performed a randomized, placebo-controlled, 7-hour crossover study in 11 healthy volunteers, attending on 3 occasions, receiving: a 70-mL shot of active beetroot juice (Beet-It) and either (i) 250 mL grapefruit juice (Active Beet+GFJ), or (ii) 250 mL water (Buxton, Active Beet+H 2  O); or (iii) Placebo Beet+GFJ.
RESULTS


The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ vs Active Beet+H 2  O (P = .02), and pulse pressure, PP (P = .0003). Peak mean differences in SBP and PP were seen at T = 5 hours: -3.3 mmHg (95% confidence interval [CI] -6.43 to -0.15) and at T = 2.5 hours: -4.2 mmHg (95% CI -0.3 to -8.2), respectively. Contrary to the hypothesis, plasma [nitrite] was lower with Active Beet+GFJ vs Active Beet+H 2  O (P = .006), as was salivary nitrite production (P = .002) and saliva volume (-0.34 mL/min [95% CI -0.05 to -0.68]). The taste score of Beet+GFJ was 1.4/10 points higher than Beet+H 2  O (P = .03).
CONCLUSION


Grapefruit juice enhanced beetroot juice's effect on lowering SBP and PP despite decreasing plasma [nitrite]. Besides suggesting more complex mechanisms, there is potential for maximising the clinical benefit of dietary nitrate and targeting isolated systolic hypertension.",2020,"The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ versus Active Beet+H 2  O (P=0.02), and pulse pressure, PP (P=0.0003).","['11 healthy volunteers, attending on 3 occasions, receiving: a 70ml-shot of active beetroot juice (Beet-It®) and either (i) 250']","['troleandomycin', 'ml grapefruit juice (""Active Beet+GFJ""), or (ii) 250 ml water (Buxton®, ""Active Beet+H 2  O""); or (iii) Placebo Beet+GFJ', 'dietary nitrate-containing beetroot juice', 'Grapefruit juice', 'placebo']","['plasma [nitrite', 'blood pressure (BP', 'saliva volume', 'systolic blood pressure', 'taste score of Beet+GFJ', 'salivary nitrite production', 'systolic BP (SBP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0041165', 'cui_str': 'Troleandomycin'}, {'cui': 'C0452456', 'cui_str': 'GRAPEFRUIT JUICE'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",11.0,0.119771,"The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ versus Active Beet+H 2  O (P=0.02), and pulse pressure, PP (P=0.0003).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': ""O'Gallagher"", 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borg Cardona', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Saedi', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shahed', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Floyd', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McNeill', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Mills', 'Affiliation': ""Biomedical Research Centre, Clinical Research Facility, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}]",British journal of clinical pharmacology,['10.1111/bcp.14420']
1337,32522263,ICT-based adherence monitoring in kidney transplant recipients: a randomized controlled trial.,"BACKGROUND


Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs.
METHODS


In this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6 months, and evaluated patient satisfaction with the ICT-based monitoring system.
RESULTS


Among 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p = 0.012).
CONCLUSIONS


Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.",2020,"CONCLUSIONS


Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs.","['kidney transplant recipients (KTRs', '114 enrolled KTRs', 'kidney transplant recipients', 'Registered 20 April 2017 - Retrospectively registered', 'Korean KTRs']","['ICT-based centralized monitoring system', 'ICT-based centralized monitoring', 'ICT-based centralized monitoring group or control group', 'ICT-based adherence monitoring', 'information and communication technology (ICT)-based centralized monitoring system']","['intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes', 'overall satisfaction', 'mean adherence', 'medication adherence and transplant outcomes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0490329,"CONCLUSIONS


Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs.","[{'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Biomedical Science and Clinical Trial Center, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jung Ju', 'Initials': 'JJ', 'LastName': 'Seo', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Biomedical Science and Clinical Trial Center, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Se-Hee', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Konyang University College of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jong Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea. ylkim@knu.ac.kr.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01146-6']
1338,32524309,Measurable residual disease after the first consolidation predicts the outcomes of patients with acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy.,"We stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of ≥ 3 × 10 9 /L (high risk) or < 3 × 10 9 /L (low risk) before administering risk-adapted chemotherapy in combination with all-trans retinoic acid (ATRA). In total, 27 low-risk and 23 high-risk patients were assigned to receive induction and three courses of consolidation with ATRA and anthracycline, followed by 2-year maintenance regimen. High-risk group additionally received cytarabine during 1st consolidation and another one-shot idarubicin treatment during 3rd consolidation. We prospectively monitored measurable residual disease (MRD) after induction and each consolidation. In the low-risk and high-risk groups, 5-year disease-free survival (DFS) rates were 86.5% and 81.2% (p = 0.862), and 5-year overall survival rates were 100% and 84.8% (p = 0.062), respectively. In the MRD-negative and MRD-positive groups, 5-year DFS rates were 91.7% and 78.4% (p = 0.402) and 84.7% and 60.0% (p = 0.102) after induction and 1st consolidation, respectively. Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively. Achieving MRD-negativity after 1st consolidation, rather than after induction, was a potential predictor of relapse and DFS in patients with APL treated with ATRA + chemotherapy.",2020,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","['stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of\u2009≥\u20093\u2009×\u200910 9', 'patients with APL treated with ATRA\u2009+\u2009chemotherapy', 'In total, 27 low-risk and 23 high-risk patients', 'patients with acute promyelocytic leukemia']","['cytarabine', 'ATRA and anthracycline']","['5-year DFS rates', 'residual disease (MRD', '5-year disease-free survival (DFS) rates', '5-year overall survival rates', 'Achieving MRD-negativity', 'Relapse rates']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",27.0,0.0290423,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","[{'ForeName': 'Hideho', 'Initials': 'H', 'LastName': 'Henzan', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kamimura', 'Affiliation': 'Department of Hematology, Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Goichi', 'Initials': 'G', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagafuji', 'Affiliation': 'Department of Hematology, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Department of Hematology, Japan Community Health Care Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujisaki', 'Affiliation': 'Department of Hematology, Matsuyama Red Cross Hospital, Ehime, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yoshikane', 'Initials': 'Y', 'LastName': 'Kikushige', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Akashi', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. toshmiya@intmed1.med.kyushu-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of hematology,['10.1007/s12185-020-02911-z']
1339,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803']
1340,32526362,Comprehensive Aneurysm Management (CAM): An All-Inclusive Care Trial for Unruptured Intracranial Aneurysms.,"BACKGROUND


In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain.
METHODS


Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years.
RESULTS


The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study.
CONCLUSIONS


Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.",2020,Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited and treatment allocation will follow an algorithm combining clinical judgment and randomization.,"['Patients eligible for at least 2 management options', 'patients with unruptured intracranial aneurysms (UIA', 'At least 961 patients recruited in at least 20 centers over 4 years will be needed for the randomized portion of the study']",['Comprehensive Aneurysm Management (CAM'],"['Survival without neurological dependency', 'incidence of SAH during follow-up and related morbidity and mortality; 2/ The morbidity and mortality related to EVT or surgical treatment of the UIA at one year; 3/ Overall morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",961.0,0.113744,Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited and treatment allocation will follow an algorithm combining clinical judgment and randomization.,"[{'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Darsaut', 'Affiliation': 'University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division Crosurgery, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cognard', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Thérapeutique du CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Januel', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Thérapeutique du CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Bourcier', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, Nantes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Boulouis', 'Affiliation': 'Service Imagerie Morphologique et Fonctionnelle, Hôpital Sainte-Anne, Paris, France.'}, {'ForeName': 'Jai Jai', 'Initials': 'JJ', 'LastName': 'Shiva Shankar', 'Affiliation': 'Department of Radiology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'J Max', 'Initials': 'JM', 'LastName': 'Findlay', 'Affiliation': 'University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division Crosurgery, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': 'Department of Radiology, Service of Interventional Neuroradiology, University of Ottawa Hospitals, Civic Campus, Ottawa, Ontario, Canada.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Boccardi', 'Affiliation': 'Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Valvassori', 'Affiliation': 'Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Magro', 'Affiliation': 'Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Gentric', 'Affiliation': 'Service de Radiologie, CHU Cavale Blanche, EA 3878 GETBO, Brest, France.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Bojanowski', 'Affiliation': ""Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Chiraz', 'Initials': 'C', 'LastName': 'Chaalala', 'Affiliation': ""Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Weill', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada.""}, {'ForeName': 'Ange', 'Initials': 'A', 'LastName': 'Diouf', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Gevry', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Chagnon', 'Affiliation': 'Department of Mathematics and Statistics, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada. Electronic address: jean.raymond@umontreal.ca.""}]",World neurosurgery,['10.1016/j.wneu.2020.06.018']
1341,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE


GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro.
AIM OF THE STUDY


The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients.
METHODS


This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients.
RESULTS


A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatments, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed.
CONCLUSIONS


GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: liuzhigang729@seu.edu.cn.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053']
1342,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE


Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
HYPOTHESIS


A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes.
CONCLUSION AND IMPLICATIONS


A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851']
1343,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION


In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy.
METHODS


We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM.
RESULTS


LS-BMD did not change significantly at year 3 compared to year 2 (-1.35 ± 1.1%, p = 1.00) and compared to baseline (-1.96 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years.
CONCLUSIONS


A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478']
1344,32540321,Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.,"PURPOSE


Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.
PATIENTS AND METHODS


The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.
RESULTS


A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).
CONCLUSIONS


The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.",2020,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","['A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group', 'patients with HNC who had undergone microvascular reconstruction from 2008 through 2013', 'Reconstructive Head and Neck Cancer Surgery', 'patients with head and neck cancer (HNC']","['perioperative DEX', 'DEX', 'no DEX', 'Perioperative Dexamethasone', 'perioperative dexamethasone (DEX']","['overall survival rate', 'death', 'deaths', 'Charlson comorbidity index (CCI', 'advanced disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",93.0,0.0680807,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Kainulainen', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. Electronic address: satu.kainulainen@hus.fi.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Consultant, Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Koivusalo', 'Affiliation': 'Consultant and Docent, Department of Anesthesia and Intensive Care Unit, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wilkman', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Professor Emeritus, Department of Health and Social Management, University of Eastern Finland, Kuopio; and Professor Emeritus, Group Administration, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Consultant, Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Törnwall', 'Affiliation': 'Docent, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lassus', 'Affiliation': 'Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.004']
1345,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE


Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed.
MATERIALS AND METHODS


Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2  weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2  weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2  biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed.
RESULTS


Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers.
CONCLUSIONS


There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011']
1346,32540725,Significant immunomodulatory properties of curcumin in patients with osteoarthritis; a successful clinical trial in Iran.,"Osteoarthritis (OA) routinely is known as a multifactorial degenerative joint disease. This trial aimed to assess the curcumin (an active element of turmeric) effects on the immune responses in OA patients. Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups; intervention (received Sinacurcumin® 80 mg daily) and placebo, followed for 3 months. In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency. Additionally, Treg cells indicated a significant increase and Treg/Th17 cells ratio showed a meaningfully shifted toward Treg lymphocytes. In conclusion, our data indicated that clinical manifestation was ameliorated considerably following the administration of curcumin. Moreover, our data demonstrated the immunomodulatory effects of curcumin in OA patients.",2020,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","['Thirty patients were selected according to the American College of Rheumatology (ACR) criteria and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and equally divided into the two groups', 'patients with osteoarthritis', 'OA patients']","['intervention (received Sinacurcumin® 80\xa0mg daily) and placebo', 'curcumin']","['Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.0327408,"In the intervention group, our data showed a noticeably decrease in Visual Analog Score (VAS), C-reactive protein (CRP), CD4 +  and CD8 +  T cells, Th17 cells and B cells frequency.","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Atabaki', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shariati-Sarabi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakkol-Afshari', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Immunology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadimzh@mums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106607']
1347,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE


To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.
STUDY DESIGN


prospective randomized study.
SETTING


Tertiary academic center.
SUBJECTS


and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods.
RESULTS


Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
CONCLUSION


Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146']
1348,32497023,l-Arginine supplementation in severe asthma.,"BACKGROUNDDysregulation of l-arginine metabolism has been proposed to occur in patients with severe asthma. The effects of l-arginine supplementation on l-arginine metabolite profiles in these patients are unknown. We hypothesized that individuals with severe asthma with low fractional exhaled nitric oxide (FeNO) would have fewer exacerbations with the addition of l-arginine to their standard asthma medications compared with placebo and would demonstrate the greatest changes in metabolite profiles.METHODSParticipants were enrolled in a single-center, crossover, double-blind l-arginine intervention trial at UCD. Subjects received placebo or l-arginine, dosed orally at 0.05 mg/kg (ideal body weight) twice daily. The primary end point was moderate asthma exacerbations. Longitudinal plasma metabolite levels were measured using mass spectrometry. A linear mixed-effect model with subject-specific intercepts was used for testing treatment effects.RESULTSA cohort of 50 subjects was included in the final analysis. l-Arginine did not significantly decrease asthma exacerbations in the overall cohort. Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P = 0.005 and P = 2.51 × 10-9, respectively). Higher AAI was associated with lower exacerbation events. The eicosanoid prostaglandin H2 (PGH2) and Nα-acetyl-l-arginine were found to be good predictors for differentiating clinical responders and nonresponders.CONCLUSIONSThere was no statistically significant decrease in asthma exacerbations in the overall cohort with l-arginine intervention. PGH2, Nα-acetyl-l-arginine, and the AAI could serve as predictive biomarkers in future clinical trials that intervene in the arginine metabolome.TRIAL REGISTRATIONClinicalTrials.gov NCT01841281.FUNDINGThis study was supported by NIH grants R01HL105573, DK097154, UL1 TR001861, and K08HL114882. Metabolomics analysis was supported in part by a grant from the University of California Tobacco-Related Disease Research Program program (TRDRP).",2020,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"['severe asthma patients', 'Participants were enrolled in a single-center, cross-over, double-blinded, L-arginine intervention trial at the University of California-Davis (NCT01841281', 'severe asthma', '50 subjects was included in the final analysis']","['L-arginine supplementation', 'placebo or L-arginine', 'placebo']","['asthma exacerbations', 'Longitudinal plasma metabolite levels', 'Higher citrulline levels and a lower arginine availability index (AAI', 'moderate asthma exacerbations', 'L-arginine metabolite profiles', 'eicosanoid prostaglandin H2 (PGH2) and Nα-Acetyl-L-arginine']","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0013725', 'cui_str': 'Eicosanoid'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin PGH2'}]",50.0,0.280177,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"[{'ForeName': 'Shu-Yi', 'Initials': 'SY', 'LastName': 'Liao', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Showalter', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Linderholm', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzi', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Kivler', 'Affiliation': 'Department of Respiratory Therapy, and.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, California, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sa', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kons', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Fiehn', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, California, USA.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Zeki', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}]",JCI insight,['10.1172/jci.insight.137777']
1349,32501985,Influences of different dose of tirofiban for acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention.,"Tirofiban is widely used in patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). This drug can efficiently improve myocardial perfusion and cardiac function, but its dose still remains controversial. We here investigated the effects of different dose of tirofiban on myocardial reperfusion and heart function in patients with STEMI. A total of 312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018 were enrolled and randomly divided into control group (75 cases, 0 μg/kg), low-dose group (79 cases, 5 μg/kg), medium-dose group (81 cases, 10 μg/kg) and high-dose group (77 cases, 20 μg/kg). The infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution were recorded. At Day 7 and Day 30 after PCI, the left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia were also evaluated. After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05). Moreover, the LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter of high-dose group were significantly improved than those of other groups, and the LVEF of medium-dose group was significantly superior to that of low-dose group (P < .05). However, the incidence of major adverse cardiac events in high-dose group was significantly decreased, while the hemorrhage and incidence of thrombocytopenia of high-dose group were significantly higher than those of other 3 groups (P < .05). The tirofiban can effectively alleviate the myocardial ischemia-reperfusion injury and promote the recovery of cardiac function in STEMI patients underwent PCI. Although the high-dose can enhance the clinical effects, it also increased the hemorrhagic risk. Therefore, the rational dosage application of tirofiban become much indispensable in view of patient's conditions and hemorrhagic risk, and a medium dose of 10 μg/kg may be appropriate for patients without high hemorrhagic risk.",2020,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","['acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention', 'patients without high hemorrhagic risk', 'patients with STEMI', '312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018', 'patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI']","['tirofiban', 'Tirofiban']","['infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution', 'left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia', 'incidence of major adverse cardiac events', 'myocardial perfusion and cardiac function', 'rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution', 'hemorrhage and incidence of thrombocytopenia', 'LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter', 'myocardial reperfusion and heart function', 'hemorrhagic risk']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",312.0,0.0198557,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department Pharmacy, the Second Clinical Hospital of Shanxi Medical University, Taiyuan, Shanxi.'}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'AstraZeneca (Wuxi) trading co. LTD, Wuxi, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000020402']
1350,32502040,"The research of Tuna Huichun Gong on pulmonary function, exercise tolerance, and quality of life in patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation.","INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is a common high-burden and highly disabling lung disease. The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles. Although recommended by the global initiative for chronic obstructive lung disease guidelines, pulmonary rehabilitation (PR) has not been used widely because of its inherent limitations. Tuna-Hui-Chun-Gong (TNHCG) is a popular traditional exercise used to treat COPD in China. We aim to evaluate the safety and efficacy of TNHCG for PR of COPD.
METHODS


The provided protocol is for a single-blind randomized controlled trial in which 120 COPD patients will be randomly and equally divided into the experimental or control group. The control group will be treated with standard COPD drugs while the experimental group will perform TNHCG exercises apart from standard drug treatment. The duration of treatment will be 24 weeks and a follow-up for 48 weeks. The primary outcome will be the 6-Minute Walk Test. The secondary outcomes will include the pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency. A safety assessment will also be performed during the trial.
DISCUSSION


Our study will provide evidence to support TNHCG exercise as an additional measure for PR of COPD.
TRIAL REGISTRATION


ChiCTR1900028332, Registered December 29, 2019.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Sichuan Traditional Chinese Medicine Regional Ethics Review Committee (No. 2019KL-050).",2020,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"['Chronic obstructive pulmonary disease (COPD', '120 COPD patients', 'patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation', 'patients with COPD', 'Registered December 29, 2019']","['Tuna Huichun Gong', 'Tuna-Hui-Chun-Gong (TNHCG', 'TNHCG', 'TNHCG exercise', 'standard COPD drugs while the experimental group will perform TNHCG exercises']","['pulmonary function, exercise tolerance, and quality of life', '6-Minute Walk Test', 'quality of life and exercise endurance', 'safety and efficacy', ""pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency""]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0041382', 'cui_str': 'Tuna'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",120.0,0.106714,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Su', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianming', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Respiratory Medicine, AVIC 363 Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020625']
1351,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002']
1352,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959']
1353,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES


Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
METHODS


Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity.
RESULTS


763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
CONCLUSION


This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027']
1354,32508323,Volume Analysis of Brain Cognitive Areas in Alzheimer's Disease: Interim 3-Year Results from the ASCOMALVA Trial.,"BACKGROUND


Cerebral atrophy is a common feature of several neurodegenerative disorders, including Alzheimer's disease (AD). In AD, brain atrophy is associated with loss of gyri and sulci in the temporal and parietal lobes, and in parts of the frontal cortex and cingulate gyrus.
OBJECTIVE


The ASCOMALVA trial has assessed, in addition to neuropsychological analysis, whether the addition of the cholinergic precursor choline alphoscerate to treatment with donepezil has an effect on brain volume loss in patients affected by AD associated with cerebrovascular injury.
METHODS


56 participants to the randomized, placebo-controlled, double-blind ASCOMALVA trial were assigned to donepezil + placebo (D + P) or donepezil + choline alphoscerate (D + CA) treatments and underwent brain magnetic resonance imaging and neuropsychological tests every year for 4 years. An interim analysis of 3-year MRI data was performed by voxel morphometry techniques.
RESULTS


The D + P group (n = 27) developed atrophy of the gray and white matter with concomitant increase in ventricular space volume. In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala. These morphological data are consistent with the results of the neuropsychological tests.
CONCLUSION


Our findings indicate that the addition of choline alphoscerate to standard treatment with the cholinesterase inhibitor donepezil counters to some extent the loss in volume occurring in some brain areas of AD patients. The observation of parallel less pronounced decrease in cognitive and functional tests in patients with the same treatment suggests that the morphological changes observed may have functional relevance.",2020,"In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala.","['patients affected by AD associated with cerebrovascular injury', '56 participants to the randomized', ""Alzheimer's Disease""]","['donepezil\u200a+\u200aplacebo (D\u200a+\u200aP) or donepezil\u200a+\u200acholine alphoscerate (D\u200a+\u200aCA) treatments and underwent brain magnetic resonance imaging and neuropsychological tests', 'donepezil', 'placebo']","['ventricular space volume', 'cognitive and functional tests', 'brain volume loss', 'gray matter atrophy']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017889', 'cui_str': 'choline alfoscerate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]",56.0,0.228653,"In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala.","[{'ForeName': 'Enea', 'Initials': 'E', 'LastName': 'Traini', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carotenuto', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}, {'ForeName': 'Angiola Maria', 'Initials': 'AM', 'LastName': 'Fasanaro', 'Affiliation': 'Neurology Unit, National Hospital ""A. Cardarelli"", Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Amenta', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190623']
1355,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND


While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity.
STUDY DESIGN


Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests.
RESULTS


The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10.
CONCLUSION


These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996']
1356,32505857,Impact of Retained Cystoscopy Fluid after Laparoscopic Hysterectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To investigate the impact of retained cystoscopy fluid after laparoscopic hysterectomy on time to spontaneous void, time to discharge, urinary retention, bladder discomfort, and patient satisfaction.
DESIGN


Single-blind randomized controlled trial.
SETTING


An academic medical center.
PATIENTS


One hundred and twenty patients who underwent laparoscopic hysterectomy with universal cystoscopy for benign indications, excluding pelvic organ prolapse and urinary incontinence indications.
INTERVENTIONS


From October 10, 2018, to October 17, 2019, we compared 200 mL retained cystoscopy fluid and complete bladder emptying after laparoscopic hysterectomy with universal cystoscopy.
MEASUREMENTS AND MAIN RESULTS


A total of 120 patients were enrolled and randomized (59 in the retained cystoscopy fluid group and 61 in the emptied fluid group). The primary outcome was time to first spontaneous void. The secondary outcomes were time to discharge, urinary retention rates, bladder discomfort, and patient satisfaction. A sample size of 120 was calculated to detect a 57-minute difference in time to spontaneous void. There were minimal differences in baseline demographics and surgical characteristics between the groups. There was an apparent, although not significant, difference in time to void of 25 minutes (143 minutes vs 168 minutes, p = .20). Time to discharge and urinary retention rates did not differ (199 minutes vs 214 minutes, p = .40, and 13.6% vs 8.2%, p = .51, respectively). There was no difference in postoperative bladder discomfort and patient satisfaction.
CONCLUSION


Retained cystoscopy fluid after laparoscopic hysterectomy did not significantly affect time to first spontaneous void, time to discharge, urinary retention, bladder discomfort, or patient satisfaction.",2020,"Time to discharge and urinary retention rate did not differ (199 minutes versus 214 minutes, p = .40 and 13.6% versus 8.2%, p = .51).","['120 patients were enrolled and randomized (59 in the retained cystoscopy fluid group, 61 in the emptied fluid group', 'One hundred and twenty patients who underwent']","['Retained Cystoscopy Fluid Following Laparoscopic Hysterectomy', 'laparoscopic hysterectomy', 'laparoscopic hysterectomy with universal cystoscopy']","['time to spontaneous void, time to discharge, urinary retention, bladder discomfort, and patient satisfaction', 'postoperative bladder discomfort and patient satisfaction', 'time to discharge, urinary retention rates, bladder discomfort, and patient satisfaction', 'time to first spontaneous void', 'Time to discharge and urinary retention rate', 'baseline demographics and surgery characteristics', 'impact time to first spontaneous void, time to discharge, urinary retention, bladder discomfort, or patient satisfaction']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",120.0,0.560774,"Time to discharge and urinary retention rate did not differ (199 minutes versus 214 minutes, p = .40 and 13.6% versus 8.2%, p = .51).","[{'ForeName': 'Rachael B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Banner-University Medical Center Phoenix, University of Arizona College of Medicine, Phoenix (Drs. Smith, Mahnert, Steck-Bayat, Womack, and Mourad). Electronic address: rachael.smith@bannerhealth.com.'}, {'ForeName': 'Nichole D', 'Initials': 'ND', 'LastName': 'Mahnert', 'Affiliation': 'Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Banner-University Medical Center Phoenix, University of Arizona College of Medicine, Phoenix (Drs. Smith, Mahnert, Steck-Bayat, Womack, and Mourad).'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson (Dr. Hu), Arizona.'}, {'ForeName': 'Kayvahn', 'Initials': 'K', 'LastName': 'Steck-Bayat', 'Affiliation': 'Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Banner-University Medical Center Phoenix, University of Arizona College of Medicine, Phoenix (Drs. Smith, Mahnert, Steck-Bayat, Womack, and Mourad).'}, {'ForeName': 'Ashley S', 'Initials': 'AS', 'LastName': 'Womack', 'Affiliation': 'Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Banner-University Medical Center Phoenix, University of Arizona College of Medicine, Phoenix (Drs. Smith, Mahnert, Steck-Bayat, Womack, and Mourad).'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Mourad', 'Affiliation': 'Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology, Banner-University Medical Center Phoenix, University of Arizona College of Medicine, Phoenix (Drs. Smith, Mahnert, Steck-Bayat, Womack, and Mourad).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.05.024']
1357,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION


Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective.
METHODS


A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups.
RESULTS


Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011']
1358,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010']
1359,32514060,"Commentary on ""A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial"".",,2020,,[],['international scientific SCI exercise guidelines'],['SCI chronic pain'],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.242921,,"[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Mulroy', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, USA. smulroy@dhs.lacounty.gov.'}]",Spinal cord,['10.1038/s41393-020-0494-7']
1360,32511114,Comparing the Efficacy of Resuscitation Educational Modalities: A Randomized Study.,"This study evaluated the efficacy of online versus instructor-led advanced cardiac life support for first-time registered nurse participants. Participants were randomized into online or instructor-led courses, with learning outcomes measured in the cognitive, psychomotor, and affective domains. The instructor-led group showed statistically significant better performance during simulated megacode. Further analysis identified key areas where instructor-led participants out-performed the online group, enabling educators to articulate risk and benefit of the two learning modalities.",2020,The instructor-led group showed statistically significant better performance during simulated megacode.,['first-time registered nurse participants'],"['Resuscitation Educational Modalities', 'online versus instructor-led advanced cardiac life support']",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0887907', 'cui_str': 'Advanced cardiac life support'}]",[],,0.0524608,The instructor-led group showed statistically significant better performance during simulated megacode.,"[{'ForeName': 'Mandi D', 'Initials': 'MD', 'LastName': 'Walker', 'Affiliation': 'Mandi D. Walker, DNP, RN, CCRN-K, NPD-BC, NEA-BC, is System Executive Director of Professional Practice, University of Louisville Health, Kentucky. Bridget Nuxoll, MSN, RN, PCCN-K, NPD-BC, is Professional Development Coordinator, University of Louisville Health, Kentucky. Sherle Niner, MSN, RN-BC, is Ancillary Staff Educator, University of Louisville Hospital, Kentucky. Thomas L. Hagan, MSN, RN, CCRN-K, NPD-BC, is Resuscitation and Simulation Educator, Robley Rex Veterans Affairs Medical Center, Louisville, Kentucky.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Nuxoll', 'Affiliation': ''}, {'ForeName': 'Sherle', 'Initials': 'S', 'LastName': 'Niner', 'Affiliation': ''}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Hagan', 'Affiliation': ''}]",Journal for nurses in professional development,['10.1097/NND.0000000000000645']
1361,31645444,Cross-Reactive CD8 T-Cell Responses Elicited by Adenovirus Type 5-Based HIV-1 Vaccines Contributed to Early Viral Evolution in Vaccine Recipients Who Became Infected.,"Because of HIV's vast sequence diversity, the ability of the CD8 T-cell response to recognize several variants of a single epitope is an important consideration for vaccine design. Cross-recognition of viral epitopes by CD8 T cells is associated with viral control during HIV-1 infection, but little is known about CD8 cross-reactivity in the context of HIV-1 vaccination. Here, we evaluated vaccine-induced CD8 cross-reactivity in two preventative HIV-1 vaccine efficacy trials, the MRKAd5 and DNA/rAd5 studies. Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection. Although responses directed against variant epitopes were less avid than responses to vaccine-matched epitopes, we did not detect any difference in response polyfunctionality (the proportion of cells producing multiple effector molecules). And while depth, or the frequency of cross-reactive responses, did not correlate with viral loads in recipients who became infected, cross-reactivity did appear to influence early viral evolution. In comparing viral sequences of placebo versus vaccine recipients, we found that viral sequences from vaccinees encoded CD8 epitopes with more substitutions and greater biochemical dissimilarity. In other words, breakthrough sequences of vaccinees would be less cross-recognized by vaccine-induced responses. Additionally, vaccine-induced CD8 T cells poorly cross-recognized variant epitopes encoding HLA-I-associated adaptations, further supporting our conclusion that these responses play a role in driving early HIV-1 viral evolution. IMPORTANCE  HIV-1 has exceptionally high sequence diversity, much of which is found within CD8 epitopes. Therefore, the ability of CD8 T cells to recognize multiple versions of a single epitope could be important for an effective vaccine. Here, we show that two previously tested vaccines induced a similar level of CD8 cross-reactivity to that seen in acute HIV-1 infection. Although this cross-reactivity did not seem to affect viral control in vaccine recipients who became infected, we identified several ways in which CD8 cross-reactivity appeared to influence HIV-1 viral evolution. First, we saw that strains isolated from infected vaccine recipients would likely be poorly cross-recognized by the vaccine-induced response. Second, we saw that adapted CD8 epitopes were poorly cross-recognized in both vaccination and infection. Collectively, we believe these results show that CD8 cross-reactivity could be an important consideration in future HIV-1 vaccine design.",2020,Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection.,['Vaccine Recipients'],['placebo'],['Cross-Reactive CD8 T-Cell Responses'],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",2.0,0.0438501,Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection.,"[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Boppana', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA pgoepfert@uabmc.edu.'}]",Journal of virology,['10.1128/JVI.01632-19']
1362,32543439,Use of a Machine Learning Program to Correctly Triage Incoming Text Messaging Replies From a Cardiovascular Text-Based Secondary Prevention Program: Feasibility Study.,"BACKGROUND


SMS text messaging programs are increasingly being used for secondary prevention, and have been shown to be effective in a number of health conditions including cardiovascular disease. SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs. However, patients regularly reply to the SMS text messages, leading to additional staffing requirements to monitor and moderate the patients' SMS text messaging replies. This additional staff requirement directly impacts the cost-effectiveness and scalability of SMS text messaging interventions.
OBJECTIVE


This study aimed to test the feasibility and accuracy of developing a machine learning (ML) program to triage SMS text messaging replies (ie, identify which SMS text messaging replies require a health professional review).
METHODS


SMS text messaging replies received from 2 clinical trials were manually coded (1) into ""Is staff review required?"" (binary response of yes/no); and then (2) into 12 general categories. Five ML models (Naïve Bayes, OneVsRest, Random Forest Decision Trees, Gradient Boosted Trees, and Multilayer Perceptron) and an ensemble model were tested. For each model run, data were randomly allocated into training set (2183/3118, 70.01%) and test set (935/3118, 29.98%). Accuracy for the yes/no classification was calculated using area under the receiver operating characteristics curve (AUC), false positives, and false negatives. Accuracy for classification into 12 categories was compared using multiclass classification evaluators.
RESULTS


A manual review of 3118 SMS text messaging replies showed that 22.00% (686/3118) required staff review. For determining need for staff review, the Multilayer Perceptron model had highest accuracy (AUC 0.86; 4.85% false negatives; and 4.63% false positives); with addition of heuristics (specified keywords) fewer false negatives were identified (3.19%), with small increase in false positives (7.66%) and AUC 0.79. Application of this model would result in 26.7% of SMS text messaging replies requiring review (true + false positives). The ensemble model produced the lowest false negatives (1.43%) at the expense of higher false positives (16.19%). OneVsRest was the most accurate (72.3%) for the 12-category classification.
CONCLUSIONS


The ML program has high sensitivity for identifying the SMS text messaging replies requiring staff input; however, future research is required to validate the models against larger data sets. Incorporation of an ML program to review SMS text messaging replies could significantly reduce staff workload, as staff would not have to review all incoming SMS text messages. This could lead to substantial improvements in cost-effectiveness, scalability, and capacity of SMS text messaging-based interventions.",2020,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.",[],"['machine learning (ML) program', 'Machine Learning Program']","['false negatives', 'receiver operating characteristics curve (AUC), false positives, and false negatives', 'false positives']",[],"[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",,0.0500675,"SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lowres', 'Affiliation': 'Heart Research Institute, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duckworth', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}]",JMIR mHealth and uHealth,['10.2196/19200']
1363,32543440,Comparison of the Effects of Automated and Manual Record Keeping on Anesthetists' Monitoring Performance: Randomized Controlled Simulation Study.,"BACKGROUND


Anesthesia information management systems (AIMSs) automatically import real-time vital signs from physiological monitors to anesthetic records, replacing part of anesthetists' traditional manual record keeping. However, only a handful of studies have examined the effects of AIMSs on anesthetists' monitoring performance.
OBJECTIVE


This study aimed to compare the effects of AIMS use and manual record keeping on anesthetists' monitoring performance, using a full-scale high-fidelity simulation.
METHODS


This simulation study was a randomized controlled trial with a parallel group design that compared the effects of two record-keeping methods (AIMS vs manual) on anesthetists' monitoring performance. Twenty anesthetists at a tertiary hospital in Hong Kong were randomly assigned to either the AIMS or manual condition, and they participated in a 45-minute scenario in a high-fidelity simulation environment. Participants took over a case involving general anesthesia for below-knee amputation surgery and performed record keeping. The three primary outcomes were participants' (1) vigilance detection accuracy (%), (2) situation awareness accuracy (%), and (3) subjective mental workload (0-100).
RESULTS


With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02). However, the result for situation awareness accuracy was inconclusive as the study did not have enough power to detect a difference between the two conditions.
CONCLUSIONS


Our findings suggest that it is promising for AIMS use to become a mainstay of anesthesia record keeping. AIMSs are effective in reducing anesthetists' workload and improving the quality of their anesthetic record keeping, without compromising vigilance.",2020,"With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02).","['Participants took over a case involving general anesthesia for below-knee amputation surgery and performed record keeping', 'Twenty anesthetists at a tertiary hospital in Hong Kong']","['two record-keeping methods (AIMS vs manual', 'Automated and Manual Record Keeping']","['subjective mental workload', 'vigilance detection accuracy (%), (2) situation awareness accuracy (%), and (3) subjective mental workload (0-100', ""participants' vigilance detection accuracy""]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002692', 'cui_str': 'Amputation of leg through tibia and fibula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1704407', 'cui_str': '100'}]",,0.128488,"With regard to the primary outcomes, there was no significant difference in participants' vigilance detection accuracy (AIMS, 56.7% vs manual, 56.7%; P=.50), and subjective mental workload was significantly lower in the AIMS condition than in the manual condition (AIMS, 34.2 vs manual, 46.7; P=.02).","[{'ForeName': 'Man-Kei', 'Initials': 'MK', 'LastName': 'Tse', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Simon Y W', 'Initials': 'SYW', 'LastName': 'Li', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Tsz Hin', 'Initials': 'TH', 'LastName': 'Chiu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chung Wai', 'Initials': 'CW', 'LastName': 'Lau', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ka Man', 'Initials': 'KM', 'LastName': 'Lam', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chun Pong Benny', 'Initials': 'CPB', 'LastName': 'Cheng', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China (Hong Kong).'}]",JMIR human factors,['10.2196/16036']
1364,32537688,Additive effect of erythropoietin use on exercise-induced endothelial activation and hypercoagulability in athletes.,"PURPOSE


Recombinant human erythropoietin (rHuEPO) is known to increase thrombotic risk in patients and might have similar effects in athletes abusing the drug. rHuEPO is prohibited by anti-doping legislation, but this risk has not been investigated thoroughly. This analysis was designed to evaluate whether rHuEPO impacts hemostatic profile and endothelial and platelet activation markers in trained subjects, and whether the combination with exercise affects exercise induced alterations.
METHODS


This double-blind, randomized, placebo-controlled trial enrolled healthy, trained male cyclists aged 18-50 years. Participants were randomly allocated (1:1) to receive subcutaneous injections of rHuEPO (epoetin-β; mean dose 6000 IU per week) or placebo (0.9% NaCl) for 8 weeks. Subjects performed five maximal exercise tests and a road race, coagulation and endothelial/platelet markers were measured at rest and directly after each exercise effort.
RESULTS


rHuEPO increased P-selectin (+ 7.8% (1.5-14.5), p = 0.02) and E-selectin (+ 8.6% (2.0-15.7), p = 0.01) levels at rest. Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
CONCLUSION


In conclusion, rHuEPO treatment resulted in elevated E- and P-selectin levels in trained cyclists, indicating enhanced endothelial activation and/or platelet reactivity. Exercise itself induces hypercoagulability, and the combination of rHuEPO and exercise increased E-selectin and PF4 levels more than either intervention alone. Based on this, exercise potentially increases thrombotic risk, a risk that might be enhanced in combination with rHuEPO use.",2020,"Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
","['athletes', 'trained subjects', 'controlled trial enrolled healthy, trained male cyclists aged 18-50\xa0years']","['Recombinant human erythropoietin (rHuEPO', 'subcutaneous injections of rHuEPO (epoetin-β; mean dose 6000\xa0IU per week) or placebo', 'rHuEPO', 'erythropoietin', 'placebo']","['thrombotic risk', 'rHuEPO increased P-selectin', 'endothelial activation and/or platelet reactivity', 'coagulation and endothelial/platelet markers', 'Platelet factor 4 (PF4) levels', 'E-selectin and PF4 levels', 'Maximal exercise tests', 'elevated E- and P-selectin levels']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032183', 'cui_str': 'Platelet factor 4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0522872', 'cui_str': 'Platelet factor 4 assay'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.148786,"Maximal exercise tests significantly influenced all measured coagulation and endothelial/platelet markers, and in the rHuEPO group maximal exercise tests led to 15.3% ((7.0-24.3%), p = 0.0004) higher E-selectin and 32.1% ((4.6-66.8%), p = 0.0207) higher Platelet factor 4 (PF4) levels compared to the placebo group.
","[{'ForeName': 'Jules A A C', 'Initials': 'JAAC', 'LastName': 'Heuberger', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands. jheuberger@chdr.nl.'}, {'ForeName': 'Jelle J', 'Initials': 'JJ', 'LastName': 'Posthuma', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ziagkos', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Department of Pulmonary Diseases, VU University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Frederik E', 'Initials': 'FE', 'LastName': 'Stuurman', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Henri M H', 'Initials': 'HMH', 'LastName': 'Spronk', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Ten Cate', 'Affiliation': 'Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Cohen', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL, Leiden, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04419-0']
1365,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND


Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake.
OBJECTIVES


This study aimed to examine the relationship between food intake and dyadic verbal interactions.
METHODS


This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function.
RESULTS


The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
CONCLUSION


Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654']
1366,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES


Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms.
METHODS


Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game.
RESULTS


Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
LIMITATIONS


Limitations include the use of a non-clinical and homogeneous sample.
CONCLUSIONS


Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588']
1367,32149709,First-in-human evaluation of a novel sirolimus-eluting ultra-high molecular weight APTITUDE bioresorbable scaffold: 9- and 24-month imaging and clinical results of the RENASCENT II trial.,"AIMS


The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention.
METHODS AND RESULTS


The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
CONCLUSIONS


In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.",2020,"No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
","['bioresorbable scaffold', 'patients undergoing percutaneous coronary intervention', '60 patients were enrolled', 'two countries (Italy and Colombia']",[],"['quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR', 'Clinical device and procedural success', 'Angiographic late lumen loss', 'TVF, MACE or stent thrombosis', 'TVF', 'TV-MI']","[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",60.0,0.0280157,"No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.
","[{'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'IRCCS, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Saud Ahmed', 'Initials': 'SA', 'LastName': 'Khawaja', 'Affiliation': ''}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': ''}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Vesga', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Moncada', 'Affiliation': ''}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Delgado', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fonseca', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrone', 'Affiliation': ''}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Cortese', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Granada', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00600']
1368,32500964,Effect of different fraction of inspired oxygen on development of atelectasis in mechanically ventilated children: A randomized controlled trial-A Comment.,,2020,,['mechanically ventilated children'],['fraction of inspired oxygen'],[],"[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",[],,0.281644,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Swarup', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Department of Pediatric Anaesthesia, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, India.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Yaddanapudi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Paediatric anaesthesia,['10.1111/pan.13854']
1369,32497491,"Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial.","BACKGROUND


Long-acting injectable cabotegravir is a novel integrase inhibitor currently in advanced clinical development for HIV prevention and treatment. We aimed to assess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 trial.
METHODS


HPTN 077 was a multicentre, double-blind, randomised, placebo-controlled phase 2a trial done at eight sites in Brazil, Malawi, South Africa, and the USA. Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV, were randomly assigned (3:1) to long-acting injectable cabotegravir (800 mg given three times at 12 week intervals or 600 mg given five times, administered at one 4 week interval, and every 8 weeks thereafter) or placebo. Participants were followed up to 76 weeks after final injection. In a prespecified analysis of secondary and exploratory outcomes, we assessed the safety, measured by the proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir during the injection phase (defined as the time between first injection and 12 weeks or 8 weeks after the last injection in cohort 1 or cohort 2 respectively) and tail phase (defined as the time between final injection and 52-76 weeks post-final injection). Safety was analysed in all participants who received at least one injection. Pharmacokinetic analyses included all participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection. Pharmacokinetic outcomes were estimated using non-compartmental methods. The trial is completed, and was registered with ClinicalTrials.gov, NCT02178800.
FINDINGS


Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2) were enrolled and received at least one injection and thus were included in the safety analysis. The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001). At 52-60 weeks after final injection, nine (23%) of 40 male participants had detectable cabotegravir concentrations and at week 76, four (13%) of 30 male participants had detectable cabotegravir concentrations compared with 52 (63%) of 82 female participants and 27 (42%) of 64 female participants at the same timepoints. The median time from the last injection to the time when cabotegravir concentration decreased below the LLOQ was 43·7 weeks (IQR 31·1-66·6; range 20·4-152·5) for male participants and 67·3 weeks (29·1-89·6; 17·7-225·5) for female participants (p=0·0003). t 1/2app  was longer for female participants than male participants (geometric mean fold-change 1·33, 95% CI 1·06-1·68; p=0·014), and longer for participants with a high body-mass index (BMI) than those with a low BMI (1·31, 1·06-1·63; p=0·015).
INTERPRETATION


The clinical significance of the long pharmacokinetic tail of cabotegravir observed in female participants compared with male participants, and those with higher BMI compared with a lower BMI, need to be addressed in future trials.
FUNDING


National Institute of Allergy and Infectious Diseases.",2020,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"['Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV', 'participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection', '82 female participants and 27 (42%) of 64 female participants at the same timepoints', 'HIV-uninfected adults', 'participants included in the HPTN 077 trial', 'Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2', 'female participants compared with male participants']","['long-acting injectable cabotegravir', 'placebo']","['Safety', 'Pharmacokinetic outcomes', 'median time', 'detectable cabotegravir concentrations', 'cabotegravir concentration', 'Tail-phase safety, tolerability, and pharmacokinetics', 'incidence of grade 2 or worse adverse events', 'proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",40.0,0.577418,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: rlandovitz@mednet.ucla.edu.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Health, San Francisco, CA, USA.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Magnus', 'Affiliation': 'Department of Epidemiology, Milken Institute School of Public Health at The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kofron', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'FHI 360, Washington, DC, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30106-5']
1370,32502445,"Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND


In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial.
METHODS


The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211.
FINDINGS


Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
INTERPRETATION


Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer.
FUNDING


MD Anderson Cancer Center and Medtronic.",2020,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
","['patients with early stage cervical cancer', '496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group', 'patients with cervical cancer after', '631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group', '33 centres worldwide', 'Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy', 'Between Jan 31, 2008, and June 22, 2017']","['open versus minimally invasive radical hysterectomy (LACC', 'radical hysterectomy', 'open or minimally invasive radical hysterectomy']","['quality of life', 'validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical', 'mean FACT-Cx total scores', 'postoperative quality of life', 'Quality of life', 'disease-free survival at 4·5 years, and quality of life', 'mean FACT-Cx total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0346202', 'cui_str': 'Adenosquamous carcinoma of cervix'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",631.0,0.221146,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mfrumovitz@mdanderson.org.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, Colombia; Clínica de Oncología Astorga, Medellín, Colombia.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribero', 'Affiliation': 'Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rendon', 'Affiliation': 'Instituto de Cancerologia-Las Americas, Medellín, Colombia.'}, {'ForeName': 'Marcus Q', 'Initials': 'MQ', 'LastName': 'Bernardini', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, ON, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marquez', 'Affiliation': 'Hospital Israelita Albert Einstein, Centro de Oncologia e Hematologia, São Paulo, Brazil.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Zevallos', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Marcelo A', 'Initials': 'MA', 'LastName': 'Vieira', 'Affiliation': 'Barretos Cancer Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Land', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30081-4']
1371,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES


To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type.
METHODS


579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group.
RESULTS


124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
CONCLUSION


We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154']
1372,32505383,"Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial.","OBJECTIVE


To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP).
DESIGN


A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial.
SETTING


Clinical centers.
PATIENT(S)


Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP.
INTERVENTION(S)


The interventions were 50, 75, 100, or 200 mg linzagolix (or matching placebo) administered once daily for 24 weeks.
MAIN OUTCOME MEASURE(S)


The primary endpoint was the number of responders (≥30% reduction in overall pelvic pain) after 12 weeks. Other endpoints included dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD).
RESULT(S)


Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively). A similar pattern was seen for dysmenorrhea and non-menstrual pelvic pain. The effects were maintained or increased at 24 weeks. Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion. Mean BMD loss (spine) at 24 weeks was <1% at doses of 50 and 75 mg and increased in a dose-dependent fashion up to 2.6% for 200 mg. BMD of femoral neck and total hip showed a similar pattern.
CONCLUSION(S)


Linzagolix significantly reduced EAP and improved QoL at doses of 75-200 mg and decreased BMD dose-dependently.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02778399.",2020,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","['Clinical centers', 'Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP']","['oral gonadotropin-releasing hormone-antagonist', 'linzagolix (or matching placebo', 'gonadotropin-releasing hormone antagonist, linzagolix', 'placebo']","['EAP and improved QoL', 'Mean BMD loss (spine', 'BMD of femoral neck and total hip', 'proportion of responders for overall pelvic pain', 'number of responders', 'rate of amenorrhea', 'overall pelvic pain', 'dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD', 'dysmenorrhea and non-menstrual pelvic pain', 'Serum estradiol']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.615483,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donnez', 'Affiliation': ""Société de recherche pour l'infertilité, Catholic University of Louvain, Leuven, Belgium.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Akin', 'Affiliation': 'Austin Area Obstetrics Gynecology and Fertility, Austin, Texas.'}, {'ForeName': 'Tatyana F', 'Initials': 'TF', 'LastName': 'Tatarchuk', 'Affiliation': 'Department of Endocrine Gynecology, Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': 'Vita Longa Sp. z o.o, Katowice, Poland.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Gotteland', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Lecomte', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Bestel', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland. Electronic address: elke.bestel@obseva.ch.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.02.114']
1373,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1374,32516410,Impact of myoglobin oxygenation level on color stability of frozen beef steaks.,"The emerging market of frozen meat emphasizes the need to better understand beef surface discoloration and the ideal parameters of freezing beef to retain an acceptable color. The objectives of this study were to determine the impacts of myoglobin oxygenation level prior to freezing and frozen storage duration on frozen beef color. USDA Choice strip loins (n = 36) were aged for 4 d or 20 d. Steaks were randomly assigned to a myoglobin oxygenation level [deoxygenated (DeOxy; immediately packaged after cutting), oxygenated (Oxy; oxygenated in air for 30 min), or highly oxygenated (HiOxy; packaged for 24 h in 80% O2)]. Steaks were then vacuum packaged in oxygen permeable or impermeable film and immediately frozen (-5 °C). Following either 0, 2, 4, or 6 mo of frozen storage, steaks were removed from the packaging and immediately analyzed for instrumental color (L*, a*, and b*), percent oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, a*:b* ratio, hue angle, subjective discoloration, and lipid oxidation. The HiOxy steaks had greater oxygen penetration and the greatest a* values compared with DeOxy and Oxy steaks, regardless of packaging (P < 0.0005). With 4 d of aging, HiOxy steaks had greater a* values than DeOxy and Oxy at all storage times (P = 0.0118). The HiOxy steaks aged for 20 d and frozen for 6 mo had significantly higher delta E values than all other myoglobin oxygenation levels and postmortem aging periods (P < 0.0001). Redness and percent oxymyoglobin were highest for HiOxy steaks within each storage period (P < 0.0002). The HiOxy steaks had the highest percent oxymyoglobin and DeOxy had the lowest percent oxymyoglobin within each aging and storage period (P < 0.01). Conversely, DeOxy steaks had the highest percent metmyoglobin and HiOxy had the lowest percent metmyoglobin when packaged in impermeable film (P < 0.0001). The HiOxy steaks from 20 d of aging had the highest discoloration compared with 4 d aging and more discoloration than all other myoglobin treatments at 6 mo of storage (P < 0.0001). The HiOxy 20 d aged steaks exhibited the highest lipid oxidation values at 2, 4, and 6 mo (P = 0.0224) and HiOxy steaks exhibited a brighter and deeper cherry red color compared with the DeOxy steaks. The HiOxy steaks were greater in redness or similar when compared with Oxy steaks, but experienced more detrimental effects when frozen storage was extended.",2020,"The HiOxy steaks had greater oxygen penetration and the greatest a* values compared to DeOxy and Oxy steaks, regardless of packaging (P < 0.0005).","['n=36) were aged for 4 d or 20 d. Steaks', 'frozen beef steaks']","['myoglobin oxygenation level', 'USDA Choice strip loins', 'myoglobin oxygenation level [deoxymyoglobin (DeOxy; immediately packaged after cutting), oxygenation (Oxy; oxygenated in air for 30 minutes), or high oxygenation (HiOxy']","['discoloration', 'delta E values', 'oxygen penetration', 'highest lipid oxidation values', 'percent oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, a*:b* ratio, hue angle, subjective discoloration, and lipid oxidation', 'Redness and percent oxymyoglobin', 'HiOxy steaks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0452850', 'cui_str': 'Beef steak'}]","[{'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085410', 'cui_str': 'Department of Agriculture (U.S.)'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0446502', 'cui_str': 'Loin (surface region)'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0851043', 'cui_str': 'Increased lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0069830', 'cui_str': 'oxymyoglobin'}, {'cui': 'C0025852', 'cui_str': 'Metmyoglobin'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.0302624,"The HiOxy steaks had greater oxygen penetration and the greatest a* values compared to DeOxy and Oxy steaks, regardless of packaging (P < 0.0005).","[{'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Henriott', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}, {'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Herrera', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}, {'ForeName': 'Kellen B', 'Initials': 'KB', 'LastName': 'Hart', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bland', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Calkins', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln.'}]",Journal of animal science,['10.1093/jas/skaa193']
1375,32518098,Phosphorylated Acetyl-CoA Carboxylase Is Associated with Clinical Benefit with Regorafenib in Relapsed Glioblastoma: REGOMA Trial Biomarker Analysis.,"PURPOSE


Preclinical studies show that antiangiogenic therapy exacerbates tumor glycolysis and activates liver kinase B1/AMP kinase (AMPK), a pathway involved in the regulation of tumor metabolism. We investigated whether certain metabolism-related  in situ  biomarkers could predict benefit to regorafenib in the phase II randomized REGOMA trial.
PATIENTS AND METHODS


IHC and digital pathology analysis were used to investigate the expression in glioblastoma (GBM) sections of monocarboxylate transporter 1 and 4 (MCT1 and MCT4), associated with OXPHOS and glycolysis, respectively, phosphorylated AMPK (pAMPK), and phosphorylated acetyl-CoA carboxylase (pACC), a canonical target of AMPK activity. The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression-free survival (PFS) in patients with relapsed GBM treated either with regorafenib or lomustine.
RESULTS


Between November 2015 and February 2017, 119 patients were enrolled ( n  = 59 regorafenib and  n  = 60 lomustine) and stratified for surgery at recurrence, and baseline characteristics were balanced. Biomarker analysis was performed in 84 patients (71%), including 42 patients of the regorafenib arm and 42 patients of the lomustine arm. Among all markers analyzed, only pACC showed predictive value in terms of OS. In fact, median OS was 9.3 months [95% confidence interval (CI), 5.6-13.2] for regorafenib and 5.5 months (95% CI, 4.2-6.6) for lomustine for pACC-positive patients, HR, 0.37 (95% CI, 0.20-0.70); log rank  P  = 0.0013; test for interaction = 0.0453. No statistically significant difference was demonstrated for PFS according to pACC status.
CONCLUSIONS


We found that AMPK pathway activation is associated with clinical benefit from treatment with regorafenib in relapsed GBM.",2020,"The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression free survival (PFS) in patients (PTS) with relapsed GBM treated either with regorafenib or lomustine.
","['patients (PTS) with relapsed GBM treated either with', '119 PTS were enrolled (n=59 regorafenib; n=60 lomustine) and stratified for surgery at recurrence; baseline characteristics were balanced', 'Between November 2015 and February 2017']","['Phosphorylated Acetyl-CoA Carboxylase', 'regorafenib or lomustine', 'lomustine']","['median OS', 'overall survival (OS) and progression free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0001022', 'cui_str': 'Acetyl-CoA carboxylase'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.150143,"The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression free survival (PFS) in patients (PTS) with relapsed GBM treated either with regorafenib or lomustine.
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Indraccolo', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy. stefano.indraccolo@unipd.it.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Verza', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Caccese', 'Affiliation': 'Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Piga', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Del Bianco', 'Affiliation': 'Clinical Research Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pizzi', 'Affiliation': 'Surgical Pathology and Cytopathology Unit, Department of Medicine-DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Marina Paola', 'Initials': 'MP', 'LastName': 'Gardiman', 'Affiliation': 'Surgical Pathology and Cytopathology Unit, University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Molecular Neuro-Oncology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Department of Neuro-Oncology, University of Turin and City of Health and Science Hospital, Turin, Italy.'}, {'ForeName': 'Alba Ariela', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Department of Medical Oncology, AUSL-IRCCS Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rizzato', 'Affiliation': 'Department of Oncology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lolli', 'Affiliation': 'Medical Oncology Unit-IRCCS Saverio de Bellis, Castellana Grotte, Bari, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4055']
1376,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5 mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511']
1377,32525525,Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial.,"CONTEXT


Consuming calories later in the day is associated with obesity and metabolic syndrome. We hypothesized that eating a late dinner alters substrate metabolism during sleep in a manner that promotes obesity.
OBJECTIVE


The objective of this work is to examine the impact of late dinner on nocturnal metabolism in healthy volunteers.
DESIGN AND SETTING


This is a randomized crossover trial of late dinner (LD, 22:00) vs routine dinner (RD, 18:00), with a fixed sleep period (23:00-07:00) in a laboratory setting.
PARTICIPANTS


Participants comprised 20 healthy volunteers (10 male, 10 female), age 26.0 ± 0.6 years, body mass index 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00 and 01:00.
INTERVENTIONS


An isocaloric macronutrient diet was administered on both visits. Dinner (35% daily kcal, 50% carbohydrate, 35% fat) with an oral lipid tracer ([2H31] palmitate, 15 mg/kg) was given at 18:00 with RD and 22:00 with LD.
MAIN OUTCOME MEASURES


Measurements included nocturnal and next-morning hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography.
RESULTS


LD caused a 4-hour shift in the postprandial period, overlapping with the sleep phase. Independent of this shift, the postprandial period following LD was characterized by higher glucose, a triglyceride peak delay, and lower FFA and dietary fatty acid oxidation. LD did not affect sleep architecture, but increased plasma cortisol. These metabolic changes were most pronounced in habitual earlier sleepers determined by actigraphy monitoring.
CONCLUSION


LD induces nocturnal glucose intolerance, and reduces fatty acid oxidation and mobilization, particularly in earlier sleepers. These effects might promote obesity if they recur chronically.",2020,"LD did not affect sleep architecture, but increased plasma cortisol.","['Healthy Volunteers', 'healthy volunteers', '20 healthy volunteers (10 males, 10 females), aged 26.0 ± 0.6 years, BMI 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00-01:00']","['late dinner', 'isocaloric macronutrient diet', 'Late Dinner', 'oral lipid tracer ([2H31] palmitate']","['fatty acid oxidation and mobilization', 'triglyceride peak delay, and lower FFA and dietary fatty acid oxidation', 'hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography', 'Nocturnal and next-morning', 'plasma cortisol', 'nocturnal glucose intolerance', 'nocturnal metabolism']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",20.0,0.0402215,"LD did not affect sleep architecture, but increased plasma cortisol.","[{'ForeName': 'Chenjuan', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Brereton', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schweitzer', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cotter', 'Affiliation': ""Arkansas Children's Nutrition Center, Arkansas Children's Research Institute, Little Rock, Arkansas.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ""Arkansas Children's Nutrition Center, Arkansas Children's Research Institute, Little Rock, Arkansas.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Pediatrics, The University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Luu V', 'Initials': 'LV', 'LastName': 'Pham', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Vsevolod Y', 'Initials': 'VY', 'LastName': 'Polotsky', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Jun', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa354']
1378,32528650,Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).,"Background:  Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy.  Methods:  This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebanon. Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable, who has not been randomised before, for whom there are no known contraindications. Randomisation - stratified (by ward) randomisation and concealed in closed opaque envelope by independent parties. Procedure - if the clinical situation arises requiring rapid tranquilisation, medical residents overseeing the patient will open a TREC-Lebanon envelope in which will be notification of which group of treatments should be preferred [Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP)], along with forms for primary, secondary and serious adverse effects. Treatment is not given blindly. Outcome - primary outcome is calm or tranquil at 20 minutes post intervention. Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward. Follow-up will be up to two weeks post randomisation.  Discussion:  Findings from this study will compare the HPC versus HP combination used in Lebanon's psychiatry emergency routine practice.  Trial registration:  ClinicalTrials.gov NCT03639558. Registration date, August 21, 2018.",2019,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","['Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable', 'agitated psychiatric patients in the emergency setting (TREC-Lebanon']","['haloperidol, promethazine and chlorpromazine combination', 'HPC versus HP combination', 'haloperidol plus promethazine plus chlorpromazine', 'haloperidol plus promethazine', 'Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP']","['calm or tranquil at 20 minutes post intervention', 'calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",,0.351427,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dib', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, NG1 1NU, UK.'}, {'ForeName': 'Clive E', 'Initials': 'CE', 'LastName': 'Adams', 'Affiliation': 'Institution of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Werner Henry', 'Initials': 'WH', 'LastName': 'Ikdais', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Atallah', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Hiba Edward', 'Initials': 'HE', 'LastName': 'Yaacoub', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Tony Jean', 'Initials': 'TJ', 'LastName': 'Merheb', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Kazour', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Tahan', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Marouan', 'Initials': 'M', 'LastName': 'Zoghbi', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Azar', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Chadia', 'Initials': 'C', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Hallit', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik, Beirut, Lebanon.'}]",F1000Research,['10.12688/f1000research.19933.1']
1379,32526634,"Randomised phase II study of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to fluoropyrimidine, irinotecan and oxaliplatin (WJOG 6510G).","BACKGROUND


Cetuximab has been shown to be clinically active when given in combination with irinotecan in patients with irinotecan-refractory metastatic colorectal cancer (mCRC). However, it has remained unclear whether panitumumab is effective when combined with irinotecan. We compared efficacies of both regimens in this randomised phase II study.
PATIENTS AND METHODS


Patients with wild-type KRAS exon 2 mCRC previously treated with fluorouracil-, oxaliplatin- and irinotecan-based chemotherapies were randomised (1:1) to either panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm). The primary end-point was progression-free survival (PFS). The planned sample size was 120, expecting a hazard ratio (HR) of 1.0 with non-inferiority margin of 1.3 (one-sided alpha error 0.2 and power 0.7). Major secondary end-points were overall survival (OS), response rate and safety.
RESULTS


From December 2011 to September 2014, 121 patients were enrolled, and 61 and 59 patients were randomised to the panitumumab and cetuximab arms, respectively (1 patient excluded). Most patients (97%) had received prior chemotherapies containing bevacizumab. The median PFS was 5.42 months in the panitumumab arm and 4.27 months in the cetuximab arm (HR = 0.64, 95% confidence interval [CI] = 0.44-0.94, P < 0.001 for non-inferiority, P = 0.058 for superiority), and median OS was 14.85 and 11.53 months (HR = 0.66, 95% CI = 0.44-1.00, P = 0.050 for superiority), respectively. The incidence of grade 3 or 4 hypomagnesaemia was higher in the panitumumab arm than that in the cetuximab arm (17% vs. 7%).
CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.",2020,"CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","['patients with KRAS wild-type metastatic colorectal cancer refractory to', 'patients with irinotecan-refractory metastatic colorectal cancer (mCRC', 'From December 2011 to September 2014', 'patients with irinotecan-refractory mCRC', '121 patients were enrolled, and 61 and 59 patients', 'Patients with wild-type KRAS exon 2 mCRC previously treated with']","['panitumumab plus irinotecan versus cetuximab plus irinotecan', 'fluoropyrimidine, irinotecan\xa0and oxaliplatin (WJOG 6510G', 'panitumumab', 'panitumumab and cetuximab', 'panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm', 'irinotecan', 'bevacizumab', 'fluorouracil-, oxaliplatin-\xa0and irinotecan-based chemotherapies']","['median OS', 'incidence of grade 3 or 4 hypomagnesaemia', 'overall survival (OS), response rate\xa0and safety', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",121.0,0.220477,"CONCLUSION


Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: dsakai@cfs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroetererological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otsu', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hozumi', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.014']
1380,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE


To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC).
METHOD


Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests.
RESULTS


In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests.
CONCLUSIONS


CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079']
1381,32526688,Examining the effect of a brief psychoeducation intervention based on self-regulation model on sexual satisfaction for women with breast cancer: A randomized controlled trial.,"PURPOSE


The main goal of this study was to investigate whether the Self-Regulation Model could improve sexual satisfaction for women diagnosed with breast cancer.
METHODS


Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran. Participants were randomly assigned to either an intervention group (n = 40) or a control group (n = 40). All participants were administered a demographic questionnaire and an Index of Sexual Satisfaction (ISS) pre-intervention, immediately post-intervention, and 1, 2, and 3 months following the intervention. The control group completed the assessments along the same time line as the intervention group. Women in the experimental group were provided three sessions of a psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies to improve their overall sexual satisfaction with sexual intercourse. Each intervention took between 60 and 90 min to administer.
RESULTS


The experimental and control group participants were well balanced in terms of demographic characteristics and sexual satisfaction scores before the intervention. The intervention group showed a positive increasing trend in the sexual satisfaction scores over time while the control group participants had a negative trend (p < 0.05). There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
CONCLUSION


Providing a psychoeducational based intervention provided an increase of sexual satisfaction during intercourse for women diagnosed with breast cancer. The psychoeducation based intervention provided an opportunity for participants to dispel common myths regarding their disease and obtain new strategies and skills to improve their sexual satisfaction from intercourse with their partners.",2019,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","['women diagnosed with breast cancer', 'Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran', 'women with breast cancer']","['psychoeducational based intervention', 'Self-Regulation Model', 'psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies', 'psychoeducation intervention based on self-regulation model']","['demographic characteristics and sexual satisfaction scores', 'sexual satisfaction scores', 'sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0482538,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Frouzan', 'Initials': 'F', 'LastName': 'Olfati', 'Affiliation': 'Metabolic Diseases Research Center, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: folfati@qums.ac.ir.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Metabolic Disease Research Center, School of Medicine, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: soveysi@qums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: nbahrami@qums.ac.ir.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Astrologo', 'Affiliation': 'Interpersonal Relationships & Development Laboratory, Centre for Research in Human Development, Department of Psychology, Concordia University, Montréal, QC, Canada. Electronic address: lisa.astrologo@live.ca.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore. Electronic address: yiong_huak_chan@nuhs.edu.sg.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101673']
1382,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
1383,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1384,32557974,Association between biomarkers and house dust mite sublingual immunotherapy in allergic asthma.,"BACKGROUND


House dust mite (HDM) sublingual immunotherapy (SLIT) has demonstrated efficacy in clinical trials of patients with asthma. Airway inflammation is a characteristic of respiratory allergy, but its relationship to SLIT remains unclear.
OBJECTIVE


We evaluate the association between clinical outcomes with pulmonary function and biomarkers in before and after HDM SLIT (UMIN Number 000022390).
METHODS


One hundred twelve patients with asthma sensitized to HDM were randomized to add-on 6 standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone for 48 weeks. At baseline and end of study, biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms were measured. Association between biomarkers and an increase in FEV 1  of 120 mL or greater were analysed.
RESULTS


Sublingual immunotherapy (SLIT) demonstrated a significant reduction of serum periostin (P < .001), FeNO (P < .01), and increase in HDM-specific IgE (P < .05), FEV 1  (P < .001) and improvement of clinical symptom scores, when compared to pharmacotherapy. The change in FEV 1  correlated with the changes in serum periostin (r = .696, P < .001) and the changes in FeNO (r = .682, P < .001). The independent predictor of improvement in airflow limitation was changed in serum periostin (r 2   = .753, P = .013) and FeNO (P = .038). Based on cut-off values derived by receiver operating characteristic analysis (periostin 30.9 ng/mL, FeNO 28.0 ppb), patients were distinguished responders from non-responders, but with no predictive value for blood eosinophils or total IgE. The proportion of patients with both high periostin and FeNO levels was significantly higher in responder than in non-responder (P = .026).
CONCLUSIONS AND CLINICAL RELEVANCE


Adding HDM SLIT to pharmacotherapy resulted in reduced serum periostin and FeNO, and improved pulmonary function. Serum periostin and FeNO may be useful biomarkers for prediction of SLIT.",2020,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","['patients with asthma', 'One hundred twelve patients with asthma sensitized to HDM', 'allergic asthma']","['standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone', 'House dust mite (HDM) sublingual immunotherapy (SLIT']","['airflow limitation', 'HDM specific IgE', 'clinical symptom scores', 'serum periostin and FeNO, and improved pulmonary function', 'FeNO levels', 'changes in FeNO', 'serum periostin', 'FeNO', 'blood eosinophils or total IgE', 'biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1270515', 'cui_str': 'House dust mite (Bt) specific immunoglobulin E'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",112.0,0.0433362,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Clinical Allergy, Department of Internal Medicine, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ohtawa', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13686']
1385,32511803,Improving Outcomes Among Young Adults with type 1 diabetes: The D1 Now Randomised Pilot Study Protocol.,"BACKGROUND


Young adults (18-25 years old) living with type 1 diabetes mellitus often have sub-optimal glycaemic levels which can increase their risk of long term diabetes complications. Informed by health psychology theory and using a (public and patient involvement) young adult-centred approach, we have developed a complex intervention, entitled D1 Now, to improve outcomes in this target group. The D1 Now intervention includes three components; 1) a support-worker, 2) an interactive messaging system and 3) an agenda setting tool for use during clinic consultations.
AIMS


The aim of the D1 Now pilot study is to gather and analyse acceptability and feasibility data to allow us to (1) refine the D1 Now intervention, and (2) determine the feasibility of a definitive Randomised Control Trial (RCT) of the intervention.
METHODS


Diabetes clinics on the island of Ireland will be recruited and randomised to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be 18-25 years old and living with type 1 diabetes for at least 12 months. Participant outcomes (influenced by a Core Outcome Set) include change in HbA1c, clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes; these will be will be measured at baseline and after 12 months follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study. ISRCTN (ref: ISRCTN74114336).",2020,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","['Young adults (aged 18-25 years) living with type 1 diabetes mellitus', 'young adults with type 1 diabetes', 'Diabetes clinics on the island of Ireland will be recruited and randomized to a D1', 'aged 18-25 years and living with type 1 diabetes for at least 12 months']",[],"['change in HbA 1c  , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.094398,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Casey', 'Affiliation': 'Physical Activity for Health Cluster, Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Casey', 'Affiliation': 'School of Nursing & Midwifery, NUI Galway, Galway, Ireland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'Health Economics & Policy Analysis Centre, Centre for Research in Medical Devices, NUI Galway, Galway, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hobbins', 'Affiliation': 'Centre for Research in Medical Devices (Cúram) and Health Economics and Policy Analysis Centre (HEPAC), NUI Galway, Galway, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Newell', 'Affiliation': 'School of Mathematics, Statistics & Applied Mathematics, NUI Galway, Galway, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Dinneen', 'Affiliation': 'School of Medicine, NUI Galway, Galway, Ireland.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14337']
1386,32513312,Dietary supplementation with seed oil from transgenic  Camelina sativa  induces similar increments in plasma and erythrocyte DHA and EPA to fish oil in healthy humans.,"EPA and DHA are required for normal cell function and can also induce health benefits. Oily fish are the main source of EPA and DHA for human consumption. However, food choices and concerns about the sustainability of marine fish stocks limit the effectiveness of dietary recommendations for EPA + DHA intakes. Seed oils from transgenic plants that contain EPA + DHA are a potential alternative source of EPA and DHA. The present study investigated whether dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA was as effective as fish oil (FO) in increasing EPA and DHA concentrations when consumed as a dietary supplement in a blinded crossover study. Healthy men and women (n 31; age 53 (range 20-74) years) were randomised to consume 450 mg/d EPA + DHA provided either as either CSO or FO for 8 weeks, followed by 6 weeks washout and then switched to consuming the other test oil. Fasting venous blood samples were collected at the start and end of each supplementation period. Consuming the test oils significantly (P < 0·05) increased EPA and DHA concentrations in plasma TAG, phosphatidylcholine and cholesteryl esters. There were no significant differences between test oils in the increments of EPA and DHA. There was no significant difference between test oils in the increase in the proportion of erythrocyte EPA + DHA (CSO, 12 %; P < 0·0001 and FO, 8 %; P = 0·02). Together, these findings show that consuming CSO is as effective as FO for increasing EPA and DHA concentrations in humans.",2020,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","['healthy humans', 'Healthy men and women (n 31; age 53 (20-74) yrs']","['dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA', 'consume 450 mg/day EPA+DHA provided either as either CSO or FO']","['EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters', 'EPA and DHA', 'proportion of erythrocyte EPA+DHA', 'Fasting venous blood samples']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003069', 'cui_str': 'Transgenic Animals'}, {'cui': 'C3474157', 'cui_str': 'CAMELINA SATIVA SEED OIL'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.0929784,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","[{'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'West', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Centre for Biological Sciences, Faculty of Natural and Environmental Sciences, University of Southampton, SouthamptonSO17 1BJ, UK.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Johnathan A', 'Initials': 'JA', 'LastName': 'Napier', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002044']
1387,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND


Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE.
METHODS


In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each.
RESULTS


At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period.
CONCLUSION


People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148']
1388,32521121,Cinematic Rendering in Anatomy: A Crossover Study Comparing a Novel 3D Reconstruction Technique to Conventional Computed Tomography.,"Integration of medical imaging into preclinical anatomy courses is already underway in many medical schools. However, interpretation of two-dimensional grayscale images is difficult and conventional volume rendering techniques provide only images of limited quality. In this regard, a more photorealistic visualization provided by Cinematic Rendering (CR) may be more suitable for anatomical education. A randomized, two-period crossover study was conducted from July to December 2018, at the University Hospital of Erlangen, Germany to compare CR and conventional computed tomography (CT) imaging for speed and comprehension of anatomy. Sixteen students were randomized into two assessment sequences. During each assessment period, participants had to answer 15 anatomy-related questions that were divided into three categories: parenchymal, musculoskeletal, and vascular anatomy. After a washout period of 14 days, assessments were crossed over to the respective second reconstruction technique. The mean interperiod differences for the time to answer differed significantly between the CR-CT sequence (-204.21 ± 156.0 seconds) and the CT-CR sequence (243.33 ± 113.83 seconds; P < 0.001). Overall time reduction by CR was 65.56%. Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001). No carryover effects were observed. A questionnaire revealed that students consider CR to be beneficial for medical education. These results suggest that CR has a potential to enhance knowledge acquisition and transfer from medical imaging data in medical education.",2020,"Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001).","['July to December 2018, at the University Hospital of Erlangen, Germany to compare CR and conventional computed tomography (CT) imaging for speed and comprehension of anatomy', 'Cinematic Rendering in Anatomy', 'participants had to answer 15 anatomy-related questions that were divided into three categories: parenchymal, musculoskeletal and vascular anatomy', 'Sixteen students']",['Novel 3D Reconstruction Technique to Conventional Computed Tomography'],"['Cinematic Rendering visualization of musculoskeletal and vascular anatomy', 'carryover effects', 'CT visualization of parenchymal anatomy']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",16.0,0.0209936,"Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001).","[{'ForeName': 'Johannes S', 'Initials': 'JS', 'LastName': 'Binder', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Institut für Funktionelle und Klinische Anatomie, Friedrich-Alexander-Universtät Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ellmann', 'Affiliation': 'Institut für Radiologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Institut für Radiologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}]",Anatomical sciences education,['10.1002/ase.1989']
1389,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757']
1390,32520654,Effects of an Individualized Active Aging Counseling Intervention on Mobility and Physical Activity: Secondary Analyses of a Randomized Controlled Trial.,"Objectives:  The aim of this study was to report preplanned secondary analyses of the effects of a 12-month individualized active aging counseling intervention on six mobility and physical activity outcomes.  Methods:  A two-arm, single-blinded randomized controlled trial was conducted among 75- and 80-year-old community-dwelling people. The intervention group (IG,  n  = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity. The control group (CG,  n  = 103) received general health information. Data were analyzed with generalized estimating equations.  Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022), self-reported physical activity increased in both groups (time  p  = .012), and autonomy in outdoor mobility declined in the IG and was enhanced in the CG (group by time  p  = .011). No change was observed for life-space mobility, proportion of persons perceiving difficulty walking 2 km, or monitored physical activity.  Discussion:  Individualized counseling aiming at increasing self-selected out-of-home activity had nonsystematic effects on mobility and positively affected physical performance only.",2020,Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022),['75- and 80-year-old community-dwelling people'],"['Individualized counseling', 'Individualized Active Aging Counseling Intervention', 'intervention group (IG,  n  = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity', 'individualized active aging counseling intervention', 'CG', 'general health information']","['six mobility and physical activity outcomes', 'autonomy in outdoor mobility', 'physical activity', 'life-space mobility, proportion of persons perceiving difficulty walking 2\xa0km, or monitored physical activity', 'Physical performance', 'Mobility and Physical Activity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0311394', 'cui_str': 'Difficulty walking'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.034241,Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022),"[{'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Siltanen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pynnönen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': '37786 University of Thessaly , Greece.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Karavirta', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Milla J', 'Initials': 'MJ', 'LastName': 'Saajanaho', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'University of Jyvaskyla , Finland.'}]",Journal of aging and health,['10.1177/0898264320924258']
1391,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972']
1392,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES


The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing.
METHODS


A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups.
RESULTS


A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
LIMITATIONS


Findings largely relate to a female undergraduate psychology sample.
CONCLUSION


Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592']
1393,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1394,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND


Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet.
METHODS


We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques.
RESULTS


All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018']
1395,32531990,Changes in Plasma Itaconate Elevation in Early Rheumatoid Arthritis Patients Elucidates Disease Activity Associated Macrophage Activation.,"Changes in the plasma metabolic profile were characterised in newly diagnosed rheumatoid arthritis (RA) patients upon commencement of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. Plasma samples collected in an early RA randomised strategy study (NCT00920478) that compared clinical (DAS) disease activity assessment with musculoskeletal ultrasound assessment (MSUS) to drive treatment decisions were subjected to untargeted metabolomic analysis. Metabolic profiles were collected at pre- and three months post-commencement of nonbiologic cDMARD. Metabolites that changed in association with changes in the DAS44 score were identified at the three-month timepoint. A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP). cDMARD treatment effects invoke consistent changes in plasma detectable metabolites, that in turn implicate clinical disease activity with macrophages. Such changes inform RA pathogenesis and reveal for the first time a link between itaconate production and resolution of inflammatory disease in humans. Quantitative metabolic biomarker-based tests of clinical change in state are feasible and should be developed around the itaconate pathway.",2020,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).",['Early Rheumatoid Arthritis Patients'],['musculoskeletal ultrasound assessment (MSUS'],"['DAS44 score', 'Metabolic profiles', 'plasma metabolic profile', 'DAS44 score and decreasing levels of C-reactive protein (CRP', 'Plasma Itaconate Elevation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0124235', 'cui_str': 'itaconate'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",9.0,0.0271239,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).","[{'ForeName': 'Rónán', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Carl S', 'Initials': 'CS', 'LastName': 'Goodyear', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Manikhandan', 'Initials': 'M', 'LastName': 'Mudaliar', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Burgess', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Stirling', 'Affiliation': 'Department of Rheumatology, Gartnavel General Hospital, Glasgow G12 0YN, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Porter', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Barrett', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}]",Metabolites,['10.3390/metabo10060241']
1396,32532790,A Three-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408.,"PURPOSE


We sought to improve upon frontline bendamustine/rituximab (BR) induction therapy followed by rituximab maintenance in untreated high-risk follicular lymphoma (FL).
PATIENTS AND METHODS


Patients were randomized to BR induction followed by 2-year rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR). Dual primary objectives were complete remission (CR) rate and 1-year disease-free survival (DFS); 289 patients enrolled (NCT01216683).
RESULTS


For induction, 92%, 87%, and 86% of patients randomized to BR-R, BVR-R, or BR-LR received six cycles, respectively. CR rate with BR versus BVR induction was 62% versus 75%, respectively ( P  = 0.04). One-year DFS rates with BR-R versus BR-LR were 85% versus 67%, respectively ( P  = 0.0009). This was due to an imbalance in CR rates post-BR induction and discontinuation due to adverse events (AEs). The most common grade 3-4 AEs for BVR versus BR were neutropenia and sensory neuropathy (12% vs <1%); 83% of the latter occurred with intravenous bortezomib. The most common grade 3-4 AEs related to LR versus rituximab maintenance were neutropenia 66% versus 21%, respectively ( P  < 0.0001), and febrile neutropenia 10% versus 2%, respectively ( P  = 0.05). The overall treatment-related mortality was 1.4%. With 5-year median follow-up, 3-year PFS rates for BR-R, BVR-R, and BR-LR were 77%, 82%, and 76%, respectively ( P  = 0.36) with OS rates of 87%, 90%, and 84%, respectively ( P  = 0.79). For prognostication, CR rate and POD-24 were associated with survival.
CONCLUSIONS


Altogether, neither bortezomib added to BR induction nor lenalidomide added to rituximab maintenance immediately post-BR induction is recommended in untreated FL.",2020,CR rate with BR  vs.  BVR induction was 62%  vs.  75% ( P =0.04).,"['Untreated Follicular Lymphoma', 'untreated high-risk follicular lymphoma (FL', 'Patients']","['bortezomib', 'Bendamustine/Rituximab with Bortezomib', 'bendamustine/rituximab (BR) induction therapy', 'rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR']","['OS rates', 'febrile neutropenia', 'CR rate and POD-24', 'overall treatment-related mortality', 'neutropenia and sensory neuropathy', 'CR rate with BR  vs.  BVR induction', '3-year PFS rates for BR-R, BVR-R, and BR-LR', 'complete remission (CR) rate and 1-year disease-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",289.0,0.0918214,CR rate with BR  vs.  BVR induction was 62%  vs.  75% ( P =0.04).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Evens', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey. ae378@cinj.rutgers.edu.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, Canada.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quon', 'Affiliation': 'University of California at Los Angeles, California.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Puneet Singh', 'Initials': 'PS', 'LastName': 'Cheema', 'Affiliation': ""Saint John's Hospital Health East Care System, Maplewood, Minnesota.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Dy', 'Affiliation': 'Decatur Memorial Hospital, Effingham, Illinois.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Cescon', 'Affiliation': 'Reading Hospital, West Reading, Pennsylvania.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Washington University, St. Louis, Missouri.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1345']
1397,32540277,High blood pressure responders show largest increase in heartbeat perception accuracy after post-learning stress following a cardiac interoceptive learning task.,"Mental disorders with physical symptoms, e.g. somatic symptom disorder, are characterized by altered interoceptive accuracy (IAc), which can be explained by individual differences in interoceptive learning (IL). We investigated if stress facilitates IL. Seventy-three healthy participants performed a heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT). After exposure to a socially-evaluated cold pressor stress test (SECPT; n = 48) or a control condition (n = 25), two more HCTs were performed (T2: 30 min after SECPT; T3: 24 h later). After the HBPT, all participants showed an increase in IAc. We separated the stress group into high vs. low systolic blood pressures (SBP) responders (n = 24 each), with high SBP responders showing the largest IAc increases. Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2. Our results indicate that post-learning autonomic stress response facilitates IL, whereas the HPA axis response may be less important for this effect.",2020,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","['Seventy-three healthy participants', 'Mental disorders with physical symptoms, e.g. somatic symptom disorder']","['heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT', 'SECPT']","['HPA axis response', 'IAc', 'systolic blood pressures (SBP) responders', 'heartbeat perception accuracy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",73.0,0.014762,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schenk', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean T M', 'Initials': 'JTM', 'LastName': 'Fischbach', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Division of Clinical Psychology, Department of Psychology, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Department of Health Psychology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg. Electronic address: andre.schulz@uni.lu.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107919']
1398,32553596,Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.,"BACKGROUND


Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking.
METHODS


COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up.
RESULTS


Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed.
CONCLUSIONS


IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.",2020,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","['patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI', 'Between November 2007 and July 2012, we enrolled 38 patients in our study', 'Males were 89% and the median age was 50.5\u202fyears']","['CD133+ BMSC', 'CD133+ cells', 'CD133+ enriched hematopoietic BMSC', 'intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC', 'placebo']","['survival rate', 'Baseline left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",38.0,0.324342,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Brian James', 'Initials': 'BJ', 'LastName': 'Potter', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Matteau', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Reeves', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Leclerc', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Rivard', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Gobeil', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Denis-Claude', 'Initials': 'DC', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Hôpital Maisonneuve-Rosemont, Montréal, Québec, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada. Electronic address: s.mansour@umontreal.ca.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.004']
1399,32553637,Acute hemodynamics of cardiac sympathetic denervation.,"INTRODUCTION


We aimed to study the immediate hemodynamic effects of thoracoscopic bilateral cardiac sympathetic denervation (CSD) for recurrent ventricular tachycardia (VT) or VT storm.
METHOD


We studied a group of 18 adults who underwent bilateral thoracoscopic CSD; the blood pressure (BP) and Heart Rate (HR) were continuously monitored during the surgery and up to 6 h post-operatively.
RESULTS


Immediately on removal of the sympathetic ganglia, the patients had a drop in both the systolic (110 mm Hg to 95.8 mm Hg, p < 0.001) and diastolic BP (69.4 mm Hg to65 mm Hg, p = 0.007) along with a drop in the HR (81.6 bpm to 61.2 bpm, p < 0.001).At 6 h after CSD, the systolic and diastolic BP did not recover significantly, while there was recovery in HR (61.2 bpm to 66 bpm, p = 0.02). There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
CONCLUSION


The acute hemodynamic changes during the perioperative period of CSD are significant but not serious. Awareness of this is useful for peri-operative management.",2020,"There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
",['18 adults who underwent'],"['bilateral thoracoscopic CSD', 'thoracoscopic bilateral cardiac sympathetic denervation (CSD']","['recovery in HR', 'systolic and diastolic BP', 'diastolic BP', 'acute hemodynamic changes', 'left ventricular (LV) systolic dysfunction', 'blood pressure (BP) and Heart Rate (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0511635,"There was no significant difference between those with and without left ventricular (LV) systolic dysfunction.
","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sinkar', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Bagchi', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India. Electronic address: avi25986@gmail.com.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Ramalingam', 'Initials': 'R', 'LastName': 'Vadivelu', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Venkatraman', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Motwani', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Vichare', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Jude', 'Initials': 'J', 'LastName': 'Vaz', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Lokhandwala', 'Affiliation': 'Holy Family Hospital, Bandra West, Mumbai, 400050, India.'}]",Indian pacing and electrophysiology journal,['10.1016/j.ipej.2020.06.006']
1400,32553642,Love at first taste: Activation in reward-related brain regions during single-trial naturalistic appetitive conditioning in humans.,"Palatable food can trigger appetitive responses, such as salivation and approach tendencies. Though evolutionarily functional, these conditioned responses can encourage overeating and obesity when food is abundant. The current study examines the neural correlates of 'denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US) during a single trial. To do so, 23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS-). After this single-trial conditioning procedure, participants viewed and rated images of the marzipan figures and the control objects during functional magnetic resonance imaging (fMRI). Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling. Furthermore, conditioning effects in subjective 'craving', defined as increased palatability and desire to eat, were observed, and these were positively related to conditioning effects in the amygdala, a brain region associated with the need-dependent value of a reward. Thus, the study identified reward-related brain regions involved in single-trial appetitive learning, thereby providing a potential mechanism that contributes to the etiology of food craving. These findings might help to understand clinically relevant food cravings in individuals with eating or weight related concerns and might support the development of extinction based treatments.",2020,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","['23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS', 'humans']","[""denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US""]","[""subjective 'craving"", 'palatability and desire to eat']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",23.0,0.0298472,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","[{'ForeName': 'Lender', 'Initials': 'L', 'LastName': 'A', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria. Electronic address: anja.lender@sbg.ac.at.'}, {'ForeName': 'Miedl', 'Initials': 'M', 'LastName': 'Sf', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Fh', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Miller', 'Initials': 'M', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Blechert', 'Initials': 'B', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113014']
1401,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND


Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome.
OBJECTIVE


To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours.
DESIGN


A two-armed randomized controlled trial.
SETTINGS AND PARTICIPANTS


A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China.
METHODS


The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program.
RESULTS


No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05).
CONCLUSIONS


The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638']
1402,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1403,32554067,Dexmedetomidine Provides Fewer Respiratory Events Compared With Propofol and Fentanyl During Third Molar Surgery: A Randomized Clinical Trial.,"PURPOSE


Propofol and fentanyl can cause airway obstruction and respiratory depression when used together for intravenous sedation. This study investigated whether dexmedetomidine and midazolam would decrease respiratory events requiring intervention during deep sedation compared with propofol, fentanyl, and midazolam.
PATIENTS AND METHODS


A prospective, randomized, double-blinded, controlled trial was designed to assess 2 intravenous treatment groups during third molar surgery. Patients were randomized into 2 groups. The control group (group P) received 0.8 μg/kg of fentanyl followed by propofol infusion at 125 μg/kg per minute over a 10-minute period with intraoperative boluses of 0.1 μg/kg. The study group (group D) received dexmedetomidine bolus infusion of 1 μg/kg over a 10-minute period followed by maintenance infusion at 0.5 μg/kg per hour. Both groups were given 0.03 mg/kg of midazolam before infusion. Scorers, masked to group, viewed the procedure remotely and evaluated the primary outcome variable of respiratory events requiring intervention. Secondary outcome variables evaluated by the scorers included the Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15 minutes, and time to ambulation and discharge. Patient satisfaction and hemodynamic stability were measured. The difference between groups regarding the occurrence of respiratory events was tested using the Fisher exact test, and mixed-effects models were used to compare repeated vital signs.
RESULTS


The sample was composed of 141 patients randomly assigned to either group P (n = 67) or group D (n = 74). No statistically significant differences in the distribution of study variables were found between groups at baseline. A statistically significant difference in respiratory events requiring deliberate intervention existed between group P (25.4%) and group D (2.7%) (P < .0001). No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
CONCLUSIONS


Using dexmedetomidine and midazolam for outpatient surgery resulted in fewer respiratory events requiring deliberate intervention compared with propofol, fentanyl, and midazolam. Ambulation and discharge times were not prolonged using dexmedetomidine.",2020,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
",['141 patients randomly assigned to either group P (n\xa0=\xa067) or group D'],"['dexmedetomidine bolus infusion of 1\xa0μg/kg over a 10-minute period followed by maintenance infusion', 'Dexmedetomidine', 'Propofol and Fentanyl', 'Propofol and fentanyl', 'fentanyl followed by propofol infusion', 'propofol, fentanyl, and midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['occurrence of respiratory events', 'Respiratory Events', 'respiratory events', 'Patient satisfaction and hemodynamic stability', 'Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction', 'Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15\xa0minutes, and time to ambulation and discharge', 'Ambulation and discharge times']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}]",141.0,0.396816,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Nolan', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY. Electronic address: PNOLAN@montefiore.org.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Delgadillo', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Youssef', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Professor of Biomedical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Chehrehsa', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.015']
1404,32554068,Does the Low-Intensity Laser Protocol Affect Tissue Healing After Third Molar Removal?,"PURPOSE


Studies have shown that laser therapy is a recommended therapy for improving the postoperative period in patients undergoing extraction of the third molars; however, there is still no definition regarding the best protocol to be used. The aim of this study was to measure and compare periodontal tissue healing using 2 different laser protocols.
MATERIALS AND METHODS


A double-blinded, randomized, prospective study with patients submitted to inferior third molar extraction was performed, with the sample divided into 3 groups according to the laser application protocol and followed for 6 months: group I, 10 J/cm 2 ; group II, 30 J/cm 2 ; and group III, sham. The primary variable was probing depth, and the secondary variables were trismus, facial edema, and pain.
RESULTS


The sample was composed of 57 patients: 19 in group I, 20 in group II, and 18 in group III. Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group I (P = .017) and 1.26 and 0.52, respectively, in group II (P = .001) compared with 0.59 and 0.49, respectively, in the sham group (P = .702), as well as a statistically significant difference for the 10-J/cm 2  laser protocol for probing depth, with values of 7.58 mm preoperatively and 9.09 mm after 6 months (P = .013).
CONCLUSIONS


The use of the low-intensity laser as adjuvant therapy after third molar extraction was more effective in the group undergoing the 10-J/cm 2  laser protocol for improving periodontal tissue healing and in both laser therapy groups for reducing facial edema.",2020,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","['patients submitted to inferior third molar extraction', 'patients undergoing extraction of the third molars']","['laser therapy', 'low-intensity laser']","['periodontal tissue healing', 'facial edema', 'trismus, facial edema, and pain', 'Tissue Healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C3873737', 'cui_str': 'Low-intensity laser'}]","[{'cui': 'C0031104', 'cui_str': 'Structure of gum and supporting structure of tooth'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",57.0,0.0358131,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bianchi de Moraes', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rúbia', 'Initials': 'R', 'LastName': 'Gomes de Oliveira', 'Affiliation': 'MS Student, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fernando Vagner', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rodrigo Dias', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Assistant Professor, Division of Periodontics, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fábio Ricardo', 'Initials': 'FR', 'LastName': 'Loureiro Sato', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil. Electronic address: fabio.sato@ict.unesp.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.018']
1405,32554646,"Study design of the Fasting In diabetes Treatment (FIT) trial: a randomised, controlled, assessor blinded intervention trial which examines the effect of intermittent use of a fasting mimicking diet in patients with type 2 diabetes.","BACKGROUND


Caloric restriction is an effective way to treat type 2 diabetes (DM2). However, chronic restriction of food intake is difficult to sustain. Intermittent total fasting exerts similar metabolic effects, but may be even more challenging for most patients. A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content. The effects of a FMD in DM2 patients are still unknown.
AIM


To determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in DM2 patients on metabolic parameters and DM2 medication use compared to usual care.
METHOD


One hundred DM2 patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and DM2 medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome, MRI (for example, cardiac function and fat distribution), cost-effectiveness, and feasibility in clinical practice.
RESULTS


The first 70 patients are included. Follow up will be completed in April 2021.
CONCLUSION


Our results will show whether monthly cycles of a FMD are feasible in clinical practice, if they improve metabolic parameters and/or reduce the need for medication in DM2 and if this is a cost-effective intervention.",2020,"A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content.","['DM2 patients', 'One hundred DM2 patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or', '70 patients are included', 'patients with type 2 diabetes']","['fasting mimicking diet', 'FMD plus usual care or usual care only', 'metformin', 'Fasting']","['HbA1c and DM2 medication dosage', 'anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome, MRI (for example, cardiac function and fat distribution), cost-effectiveness, and feasibility in clinical practice']","[{'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",100.0,0.0760141,"A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content.","[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'van den Burg', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Schoonakker', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'van den Akker', 'Affiliation': 'Medical Decision Making, Leiden University Medical Center.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Human Genetics, Leiden University Medical Center.'}, {'ForeName': 'Hildo', 'Initials': 'H', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center.'}, {'ForeName': 'Mattijs', 'Initials': 'M', 'LastName': 'Numans', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'van Peet', 'Affiliation': 'Public Health and Primary Care, Leiden University Medical Center.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711173']
1406,32554648,Anticipatory care planning for older adults: a trans-jurisdictional feasibility study.,"BACKGROUND


As the population of older adults' increases, the complexity of care required to support those who choose to remain in the community has also increased. Anticipatory Care Planning (ACP) through earlier identification of healthcare needs is evidenced to improve quality of life, decrease the number of aggressive futile interventions, and even to prolong life.
AIM


To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
METHOD


GP practices were randomised into control/intervention groups stratified by jurisdiction [Northern Ireland (UK) and the Republic of Ireland (RoI)], and by setting (urban and rural). Participants were included if they were a) aged ≥70 years, b) 2 or more chronic medical conditions, c) 4 or more prescribed medications. The Anticipatory Care Plan consisted of home visits where the study nurse discussed patients' goals and plans. An action plan was put in place following consultation with patient's GPs and study Pharmacist.
RESULTS


Eight primary care practices participated; four in the UK and four in the RoI. Sample  n  = 64. Data was collected pertaining to patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and the use of potentially inappropriate medication.
CONCLUSION


Unique insights relating to the trans-jurisdictional delivery of healthcare services in the UK and RoI were observed which has implications on service delivery for older adults.",2020,"To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
","['primary care to assist older adults', 'GP practices', 'older adults', 'Participants were included if they were a) aged ≥70 years, b) 2 or more chronic medical conditions, c) 4 or more prescribed medications']","['Anticipatory care planning', 'control/intervention groups stratified by jurisdiction [Northern Ireland (UK) and the Republic of Ireland (RoI', 'Anticipatory Care Planning (ACP']","['patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and the use of potentially inappropriate medication']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]",,0.044586,"To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Corry', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Doherty', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Doyle', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cardwell', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Paddy', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'National University of Ireland Galway.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McGlade', 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'Queens University Belfast.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Royal College of Surgeons Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brazil', 'Affiliation': 'Queens University Belfast.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711197']
1407,32554653,MULTIPAP Study: Improving healthcare for patients with multimorbidity.,"BACKGROUND


The steady rise in multimorbidity entails serious consequences for our populations, challenges healthcare systems, and calls for specific clinical approaches of proven effectiveness. The MULTIPAP Study comprises three sequential projects (MULTIPAP and MULTIPAP Plus RCTs, and the MULTIPAP Cohort). Results of MULTIPAP RCT are presented.
AIM


To evaluate the effectiveness of a complex, patient-centred intervention in young-old patients with multimorbidity and polypharmacy.
METHOD


Pragmatic cluster-randomised clinical trial in a primary healthcare setting. GPs were randomly allocated to either conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training (that is, eMULTIPAP addresses specific, key concepts on multimorbidity, polypharmacy and shared decision-making) and GP-patient-centred interview. Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included.
MAIN OUTCOME


difference in the Medication Appropriateness Index (MAI) after 6-month follow-up between groups.
SECONDARY OUTCOMES


MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness after 12-month follow-up.
RESULTS


117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups. Difference in MAI scores between groups in the intention-to-treat analysis after 6 months' follow-up: -2.42 (-4.27 to -0.59),  P  = 0.009 (adjusted difference in mean MAI score -1.81(-3.35 to -0.27),  P  = 0.021).
SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
CONCLUSION


The intervention significantly improved medication appropriateness. The observed quality of life improvement was not significant. GPs e-training in multimorbidity has shown to be feasible and well accepted by the professionals. Future studies may test whether this format facilitates implementation.",2020,"SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
","['Pragmatic cluster-randomised clinical trial in a primary healthcare setting', 'patients with multimorbidity', '117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups', 'Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included', 'young-old patients with multimorbidity and polypharmacy']","['MULTIPAP', 'complex, patient-centred intervention', 'MULTIPAP RCT', 'conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training']","['quality of life', 'observed quality of life improvement', 'mean EQ-5D-5L (VAS', 'mean MAI score', 'MAI scores', 'MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness', 'medication appropriateness', 'Medication Appropriateness Index (MAI']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",593.0,0.085902,"SECONDARY OUTCOMES


not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28),  P  = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022),  P  = 0.689).
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute, Miguel Servet University Hospital, Zaragoza, Spain.'}, {'ForeName': 'Isabel Del', 'Initials': 'ID', 'LastName': 'Cura-González', 'Affiliation': 'Primary Care Research Unit, Gerencia de Atención Primaria. Department of Preventive Medicine and Public Health, University Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': ""Multiprofesional Teaching Unit of Community and Family Atention 'Distrito Atención Primaria Málaga-Guadalhorce', Málaga, Spain.""}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': ""Multiprofesional Teaching Unit of Community and Family Atention 'Distrito Atención Primaria Málaga-Guadalhorce', Andalusian Health Service, Málaga, Spain.""}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Lopez-Rodriguez', 'Affiliation': 'Primary Care Research Unit, Gerencia de Atención Primaria. Department of Preventive Medicine and Public Health, University Rey Juan Carlos, General Ricardos Primary Health Care Centre, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'González-Rubio', 'Affiliation': 'EpiChron Research Group on Chronic Diseases, Aragon Health Sciences Institute, Aragón; Miguel Servet University Hospital, Delicias-Sur Primary Care Health Centre, SALUD, Zaragoza, Spain.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711257']
1408,32554688,Multiple risk behaviour intervention to prevent depression in primary care.,"BACKGROUND


Primary care is the ideal setting for promotion and prevention intervention. Multiple risk behaviour interventions present several advantages over single-risk lifestyle interventions. Multiple risk behaviour interventions could be easily implemented in primary care to prevent non-communicable disease and depression.
AIM


To test the effectiveness of a multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation in people attending Spanish primary health care with incidence of depression and symptoms of depression.
METHOD


This was a secondary analysis of the EIRA study that aims to test the effectiveness of a multiple risk behaviour intervention to promote healthy lifestyles. Twenty-six primary care centres were randomised to receive multiple risk behaviour intervention or usual care. The multiple risk behaviour intervention included individual sessions, group sessions, communitarian activities, and SMS reception. Participants were followed for 10-14 months. The primary outcomes of this study were incidence of depression and reductions of depressive symptoms.
RESULTS


Three thousand and sixty-seven participants were included. Females accounted for 45.13% and 93.88% were Spanish. Age varied between 45 and 75 years old. The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section. Linear and logistic regression will be used to create predictive models.
CONCLUSION


Primary care is the most accessible service in the health system for patients. Hence primary care is the ideal setting for health education, promotion, and prevention interventions. This study will provide high-quality evidence about the effectiveness of multiple risk behaviour interventions over depression prevention.",2020,The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section.,"['Age varied between 45 and 75 years old', 'people attending Spanish primary health care with incidence of depression and symptoms of depression', 'Twenty-six primary care centres', 'Three thousand and sixty-seven participants were included', 'healthy lifestyles']","['multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation', 'multiple risk behaviour intervention', 'multiple risk behaviour intervention or usual care', 'Multiple risk behaviour intervention']","['communitarian activities, and SMS reception', 'Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (\u200eCIDI)\u200e depression section', 'incidence of depression and reductions of depressive symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",3067.0,0.0338549,The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview (‎CIDI)‎ depression section.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gómez-Gómez', 'Affiliation': 'Universidad Loyola Andalucía.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Moreno-Peral', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'López', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Clavería', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Oliván', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Marti', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Jose-Angel', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernández', 'Affiliation': 'Network for Prevention and Health Promotion in Primary Care.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Motrico', 'Affiliation': 'Universidad Loyola Andalucía.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711677']
1409,32559463,Dynamic trial fitting by an expanding trial cup does not jeopardize primary acetabular component stability.,"BACKGROUND


Trial fitting of the acetabular component in uncemented total hip replacement is traditionally done by trial cups. Since trial cups do not resemble the real press-fit obtained by the definitive cup, a dynamic trial inserter, called the X-pander ®, was developed to mimic the real amount of press-fit. However, the concern is raised of losing the initial press-fit by using the X-pander® due to pre-expansion of the acetabulum. The purpose of this study was to assess if there is a difference in primary stability between both methods.
METHODS


A biomechanical randomized study was performed with bovine calf acetabula, with randomization between either using the X-pander® or the traditional trial cups to assess primary stability. The primary outcome was the force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up.
FINDINGS


In total, 54 cups (19 Anexys, 35 Trident) were inserted and tested after randomized trial fitting. Overall mean lever out was 45.1 Nm (SD 14.6) for the X-pander® group and 45.0 Nm (SD 14.5) for the trial cups group. After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
INTERPRATION


Initial press-fit of the implanted cup is not lost by pre-expansion as done with dynamic trial fitting with the X-pander®.",2020,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
",[],"['INTERPRATION', 'bovine calf acetabula']","['force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0000962', 'cui_str': 'Bone structure of acetabulum'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1430904', 'cui_str': 'FOXM1 protein, human'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542569', 'cui_str': 'newton'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",54.0,0.260371,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77).
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.hoornenborg@xpertorthopedie.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Loon', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands; Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: justin.vanloon@amc.uva.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'de Waard', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: i.n.sierevelt@score-amsterdam.nl.'}, {'ForeName': 'K T M', 'Initials': 'KTM', 'LastName': 'Opdam', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: k.t.opdam@amc.uva.nl.'}, {'ForeName': 'G M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: g.m.kerkhoffs@amc.uva.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.haverkamp@xpertorthopedie.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105077']
1410,32520410,"First-in-human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of SAR247799, a selective G-protein-biased sphingosine-1 phosphate receptor-1 agonist for endothelial protection.","AIMS


SAR247799 is a selective G-protein-biased sphingosine-1 phosphate receptor-1 (S1P 1  ) agonist with potential to restore endothelial function in vascular pathologies. SAR247799, a first-in-class molecule differentiated from previous S1P 1  -desensitizing molecules developed for multiple sclerosis, can activate S1P 1  without desensitization and consequent lymphopenia. The aim was to characterize SAR247799 for its safety, tolerability, pharmacokinetics and pharmacodynamics (activation and desensitization).
METHODS


SAR247799 was administered orally to healthy subjects in a double-blind, randomized, placebo-controlled study with single (2.5-37.5 mg) or 2-week once-daily (0.5-15 mg) doses. An open-label single dose pilot food-interaction arm with 10 mg SAR247799 in cross-over design was also performed.
RESULTS


SAR247799 was well tolerated and, at the higher end of the dose ranges, caused the expected dose-dependent pharmacodynamics associated with S1P 1  activation (heart rate reduction) and S1P 1  desensitization (lymphocyte count reduction). SAR247799 demonstrated dose-proportional increases in exposure and was eliminated with an apparent terminal half-life of 31.2-33.1 hours. Food had a small effect on the pharmacokinetics of SAR247799. SAR247799 had a low volume of distribution (7-23 L), indicating a potential to achieve dose separation for endothelial vs cardiac S1P 1  activation pharmacology. A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1  activation without tachyphylaxis. Sub-lymphocyte-reducing doses (≤5 mg) of SAR247799, which, based on preclinical data, are projected to activate S1P 1  and exhibit endothelial-protective properties, had minimal-to-no heart rate reduction and displayed no marked safety findings.
CONCLUSION


SAR247799 is suitable for exploring the biological role of endothelial S1P 1  activation without causing receptor desensitization.",2020,"A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1  activation without tachyphylaxis.",['healthy subjects'],"['placebo', 'SAR247799']","['safety, tolerability, pharmacokinetics and pharmacodynamics (activation and desensitization', 'sustained heart rate reduction', 'safety, tolerability, pharmacokinetics and pharmacodynamics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0378777,"A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1  activation without tachyphylaxis.","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bergougnan', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Armani', 'Affiliation': 'Parexel International GmBH, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmBH, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tardat', 'Affiliation': 'Sanofi R&D, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vitse', 'Affiliation': 'Sanofi R&D, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Hurbin', 'Affiliation': 'Sanofi R&D, Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Scemama', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Poitiers', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radzik', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Gaudin', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Hovsepian', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Muslin', 'Affiliation': 'Sanofi US Services, Cambridge, MA, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Kirkesseli', 'Affiliation': 'Sanofi R&D, Chilly Mazarin, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deutsch', 'Affiliation': 'Sanofi US Services, Bridgewater, NJ, USA.'}, {'ForeName': 'Ashfaq A', 'Initials': 'AA', 'LastName': 'Parkar', 'Affiliation': 'Sanofi US Services, Bridgewater, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14422']
1411,32521284,The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study.,"BACKGROUND


The purpose of this study was to evaluate the effect of low-frequency self-administered vibration therapy into myofascial trigger points in the upper trapezius and levator scapulae on patients with chronic non-specific neck pain.
METHODS


Twenty-eight patients with chronic non-specific neck pain were randomly assigned into a vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention. Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold were assessed at baseline and after the first, fifth and 10th treatment sessions.
FINDINGS


Significant differences were found in the vibration group when compared to the control group after the treatment period: the vibration group reached lower Neck Disability Index scores (F = 4.74, P = .033, η 2  = 0.07) and greater pressure pain threshold values (F = 7.56, P = .01, η 2  = 0.10) than the control group. The vibration group reported a significant reduction in Neck Disability Index scores (χ2 = 19,35, P = .00, Kendall's W = 0.28) and an increase in pressure pain threshold (χ2 = 87,10, P = .00, Kendall's W = 0.73) between the assessment times over the course of the treatment. The mean increase in pressure pain threshold in the vibration group after the 10 sessions was 8.54 N/cm2, while the mean reduction in Neck Disability Index scores was 4.53 points.
INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain. This tool could be recommended for people with non-specific neck pain.",2020,"INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","['people with non-specific neck pain', 'patients with chronic non-specific neck pain', 'Twenty-eight patients with chronic non-specific neck pain']","['low-frequency self-administered vibration therapy', 'vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention', 'vibration therapy']","['Neck Disability Index scores', 'Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold', 'pressure pain threshold', 'neck myofascial trigger points', 'pressure pain threshold values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0224475,"INTERPRETATION


Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: lirios.duenas@uv.es.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'European Sleep Care Institute, San Vicente 16, 46023, Valencia, Spain. Electronic address: innovation@escinstitute.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain; ""Pain in Motion"" international research group, Belgium. Electronic address: enrique.lluch@uv.es.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Artacho-Ramírez', 'Affiliation': 'Department of Engineering Projects, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: miarra@dpi.upv.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mayoral', 'Affiliation': 'Physical Therapy Unit, Hospital Provincial de Toledo, Toledo, Spain. Electronic address: orlando.mayoral@uclm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balasch', 'Affiliation': 'Departamento de Estadística e Investigación Operativa Aplicadas y Calidad, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: sbalasch@eio.upv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balasch-Bernat', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: merce.balasch@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105071']
1412,32522198,Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction (METOCARD-CNIC randomized clinical trial substudy).,"BACKGROUND


We aimed to evaluate the effect of early intravenous metoprolol treatment, microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV) remodeling on the evolution of infarct and remote zone circumferential strain after acute anterior ST-segment elevation myocardial infarction (STEMI) with feature-tracking cardiovascular magnetic resonance (CMR).
METHODS


A total of 191 patients with acute anterior STEMI enrolled in the METOCARD-CNIC randomized clinical trial were evaluated. LV infarct zone and remote zone circumferential strain were measured with feature-tracking CMR at 1 week and 6 months after STEMI.
RESULTS


In the overall population, the infarct zone circumferential strain significantly improved from 1 week to 6 months after STEMI (- 8.6 ± 9.0% to - 14.5 ± 8.0%; P < 0.001), while no changes in the remote zone strain were observed (- 19.5 ± 5.9% to - 19.2 ± 3.9%; P = 0.466). Patients who received early intravenous metoprolol had significantly more preserved infarct zone circumferential strain compared to the controls at 1 week (P = 0.038) and at 6 months (P = 0.033) after STEMI, while no differences in remote zone strain were observed. The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001). In patients who developed adverse LV remodeling (defined as ≥ 20% increase in LV end-diastolic volume) remote zone circumferential strain worsened between 1 week and 6 months after STEMI (P = 0.036), while in the absence of adverse LV remodeling no significant changes in remote zone strain were observed.
CONCLUSIONS


Regional LV circumferential strain with feature-tracking CMR allowed comprehensive evaluation of the sequelae of an acute STEMI treated with primary percutaneous coronary intervention and demonstrated long-lasting cardioprotective effects of early intravenous metoprolol.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01311700. Registered 8 March 2011 - Retrospectively registered.",2020,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","['191 patients with acute anterior STEMI enrolled', 'Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction']",['metoprolol'],"['preserved infarct zone circumferential strain', 'LV infarct zone and remote zone circumferential strain', 'adverse LV remodeling', 'remote zone strain', 'LV end-diastolic volume) remote zone circumferential strain', 'infarct zone circumferential strain', 'MVO or IMH', 'microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",191.0,0.133452,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Greif', 'Affiliation': 'Faculty of Medicine University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nina Ajmone', 'Initials': 'NA', 'LastName': 'Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. v.delgado@lumc.nl.'}]",Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance,['10.1186/s12968-020-00638-8']
1413,32525036,"One layer or two: Does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088']
1414,32430908,Changes in perampanel levels during de-induction: Simulations following carbamazepine discontinuation.,"OBJECTIVE


To evaluate the time course of changes in perampanel levels when co-administered with carbamazepine, and following carbamazepine discontinuation, using a physiologically based pharmacokinetic (PBPK) model.
METHODS


The PBPK model was developed, verified using clinical PK data, and used to simulate the effect of abrupt discontinuation and down-titration (75 mg twice daily [bid]/wk) of co-administered carbamazepine 300 mg bid on the PK of perampanel once daily (qd). Perampanel dose tapering (8-4 mg) and up-titration (2-6 mg) were simulated during abrupt carbamazepine 300 mg bid discontinuation to identify a titration schedule that minimizes changes in perampanel plasma concentrations.
RESULTS


The PBPK model accurately reproduced perampanel plasma concentration-time profiles from clinical studies in single- and multiple-dose regimen simulations, including multiple-dose carbamazepine co-administration. The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days). Perampanel dose tapering (8-4 mg) at abrupt carbamazepine discontinuation produced minimal changes in steady-state concentrations, which returned to the levels observed during carbamazepine co-administration in ~15 days from the time of carbamazepine discontinuation. When perampanel was up-titrated in the presence of carbamazepine, return to steady state occurred more slowly when carbamazepine was down-titrated weekly (~45 days) vs abrupt discontinuation (~24 days).
CONCLUSION


This PBPK model simulated and predicted optimal perampanel dose tapering and up-titration schedules for maintaining perampanel levels during conversion to monotherapy. These results may guide physicians when managing conversion from perampanel polytherapy with concomitant enzyme-inducing anti-seizure medications to monotherapy.",2020,The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days).,[],"['carbamazepine', 'carbamazepine 300\xa0mg bid on the PK of perampanel', 'Perampanel', 'perampanel']","['time course of return to pre-induced perampanel levels', 'steady-state concentrations', 'perampanel levels']",[],"[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0984515', 'cui_str': 'Carbamazepine 300 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]","[{'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0293076,The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days).,"[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Schuck', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ferry', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hussein', 'Affiliation': 'Eisai Ltd., Hatfield, Hertfordshire, UK.'}]",Acta neurologica Scandinavica,['10.1111/ane.13286']
1415,32529506,Left atrial mechanics and aortic stiffness following high intensity interval training: a randomised controlled study.,"PURPOSE


High intensity interval training (HIIT) has been shown to improve important health parameters, including aerobic capacity, blood pressure, cardiac autonomic modulation and left ventricular (LV) mechanics. However, adaptations in left atrial (LA) mechanics and aortic stiffness remain unclear.
METHODS


Forty-one physically inactive males and females were recruited. Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20). The HIIT protocol consisted of 3 × 30-s maximal cycle ergometer sprints with a resistance of 7.5% body weight, interspersed with 2-min of active unloaded recovery, three times per week. Speckle tracking imaging of the LA and M-Mode tracing of the aorta was performed pre and post HIIT and control period.
RESULTS


Following HIIT, there was significant improvement in LA mechanics, including LA reservoir (13.9 ± 13.4%, p = 0.033), LA conduit (8.9 ± 11.2%, p = 0.023) and LA contractile (5 ± 4.5%, p = 0.044) mechanics compared to the control condition. In addition, aortic distensibility (2.1 ± 2.7 cm 2  dyn -1  10 3 , p = 0.031) and aortic stiffness index (- 2.6 ± 4.6, p = 0.041) were improved compared to the control condition. In stepwise linear regression analysis, aortic distensibility change was significantly associated with LA stiffness change R 2  of 0.613 (p = 0.002).
CONCLUSION


A short-term programme of HIIT was associated with a significant improvement in LA mechanics and aortic stiffness. These adaptations may have important health implications and contribute to the improved LV diastolic and systolic mechanics, aerobic capacity and blood pressure previously documented following HIIT.",2020,Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20).,['Forty-one physically inactive males and females were recruited'],"['HIIT', 'High intensity interval training (HIIT', '4-week HIIT intervention (n\u2009=\u200921) or 4-week control period', '3\u2009×\u200930-s maximal cycle ergometer sprints', 'high intensity interval training']","['LA mechanics, including LA reservoir', 'aortic stiffness index', 'LA conduit', 'aortic distensibility', 'LA contractile', 'aortic distensibility change', 'aerobic capacity, blood pressure, cardiac autonomic modulation and left ventricular (LV) mechanics', 'LV diastolic and systolic mechanics, aerobic capacity and blood pressure', 'Left atrial mechanics and aortic stiffness', 'LA mechanics and aortic stiffness']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",41.0,0.0203641,Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20).,"[{'ForeName': 'Navazh', 'Initials': 'N', 'LastName': 'Jalaludeen', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Bull', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Taylor', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Wiles', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Damian A', 'Initials': 'DA', 'LastName': 'Coleman', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Howland', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mukhtar', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': ""Department of Cardiology, St George's Healthcare NHS Trust, Blackshaw Road, Tooting, London, UK.""}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': ""O'Driscoll"", 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK. jamie.odriscoll@canterbury.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-020-04416-3']
1416,32526091,Interventions to prevent women from developing gestational diabetes mellitus: an overview of Cochrane Reviews.,"BACKGROUND


The prevalence of gestational diabetes mellitus (GDM) is increasing, with approximately 15% of pregnant women affected worldwide, varying by country, ethnicity and diagnostic thresholds. There are associated short- and long-term health risks for women and their babies.
OBJECTIVES


We aimed to summarise the evidence from Cochrane systematic reviews on the effects of interventions for preventing GDM.
METHODS


We searched the Cochrane Database of Systematic Reviews (6 August 2019) with key words 'gestational diabetes' OR 'GDM' to identify reviews pre-specifying GDM as an outcome. We included reviews of interventions in women who were pregnant or planning a pregnancy, irrespective of their GDM risk status. Two overview authors independently assessed eligibility, extracted data and assessed quality of evidence using ROBIS and GRADE tools. We assigned interventions to categories with graphic icons to classify the effectiveness of interventions as: clear evidence of benefit or harm (GRADE moderate- or high-quality evidence with a confidence interval (CI) that did not cross the line of no effect); clear evidence of no effect or equivalence (GRADE moderate- or high-quality evidence with a narrow CI crossing the line of no effect); possible benefit or harm (low-quality evidence with a CI that did not cross the line of no effect or GRADE moderate- or high-quality evidence with a wide CI); or unknown benefit or harm (GRADE low-quality evidence with a wide CI or very low-quality evidence).
MAIN RESULTS


We included 11 Cochrane Reviews (71 trials, 23,154 women) with data on GDM. Nine additional reviews pre-specified GDM as an outcome, but did not identify GDM data in included trials. Ten of the 11 reviews were judged to be at low risk of bias and one review at unclear risk of bias. Interventions assessed included diet, exercise, a combination of diet and exercise, dietary supplements, pharmaceuticals, and management of other health problems in pregnancy. The quality of evidence ranged from high to very low. Diet Unknown benefit or harm: there was unknown benefit or harm of dietary advice versus standard care, on the risk of GDM: risk ratio (RR) 0.60, 95% CI 0.35 to 1.04; 5 trials; 1279 women; very low-quality evidence. There was unknown benefit or harm of a low glycaemic index diet versus a moderate-high glycaemic index diet on the risk of GDM: RR 0.91, 95% CI 0.63 to 1.31; 4 trials; 912 women; low-quality evidence. Exercise Unknown benefit or harm: there was unknown benefit or harm for exercise interventions versus standard antenatal care on the risk of GDM: RR 1.10, 95% CI 0.66 to 1.84; 3 trials; 826 women; low-quality evidence. Diet and exercise combined Possible benefit: combined diet and exercise interventions during pregnancy versus standard care possibly reduced the risk of GDM: RR 0.85, 95% CI 0.71 to 1.01; 19 trials; 6633 women; moderate-quality evidence. Dietary supplements Clear evidence of no effect: omega-3 fatty acid supplementation versus none in pregnancy had no effect on the risk of GDM: RR 1.02, 95% CI 0.83 to 1.26; 12 trials; 5235 women; high-quality evidence. Possible benefit: myo-inositol supplementation during pregnancy versus control possibly reduced the risk of GDM: RR 0.43, 95% CI 0.29 to 0.64; 3 trials; 502 women; low-quality evidence. Possible benefit: vitamin D supplementation versus placebo or control in pregnancy possibly reduced the risk of GDM: RR 0.51, 95% CI 0.27 to 0.97; 4 trials; 446 women; low-quality evidence. Unknown benefit or harm: there was unknown benefit or harm of probiotic with dietary intervention versus placebo with dietary intervention (RR 0.37, 95% CI 0.15 to 0.89; 1 trial; 114 women; very low-quality evidence), or probiotic with dietary intervention versus control (RR 0.38, 95% CI 0.16 to 0.92; 1 trial; 111 women; very low-quality evidence) on the risk of GDM. There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM. Pharmaceutical Possible benefit: metformin versus placebo given to obese pregnant women possibly reduced the risk of GDM: RR 0.85, 95% CI 0.61 to 1.19; 3 trials; 892 women; moderate-quality evidence. Unknown benefit or harm:eight small trials with low- to very low-quality evidence showed unknown benefit or harm for heparin, aspirin, leukocyte immunisation or IgG given to women with a previous stillbirth on the risk of GDM. Management of other health issues Clear evidence of no effect: universal versus risk based screening of pregnant women for thyroid dysfunction had no effect on the risk of GDM: RR 0.93, 95% CI 0.70 to 1.25; 1 trial; 4516 women; moderate-quality evidence. Unknown benefit or harm: there was unknown benefit or harm of using fractional exhaled nitrogen oxide versus a clinical algorithm to adjust asthma therapy on the risk of GDM: RR 0.74, 95% CI 0.31 to 1.77; 1 trial; 210 women; low-quality evidence. There was unknown benefit or harm of pharmacist led multidisciplinary approach to management of maternal asthma versus standard care on the risk of GDM: RR 5.00, 95% CI 0.25 to 99.82; 1 trial; 58 women; low-quality evidence.
AUTHORS' CONCLUSIONS


No interventions to prevent GDM in 11 systematic reviews were of clear benefit or harm. A combination of exercise and diet, supplementation with myo-inositol, supplementation with vitamin D and metformin were of possible benefit in reducing the risk of GDM, but further high-quality evidence is needed. Omega-3-fatty acid supplementation and universal screening for thyroid dysfunction did not alter the risk of GDM. There was insufficient high-quality evidence to establish the effect on the risk of GDM of diet or exercise alone, probiotics, vitamin D with calcium or other vitamins and minerals, interventions in pregnancy after a previous stillbirth, and different asthma management strategies in pregnancy. There is a lack of trials investigating the effect of interventions prior to or between pregnancies on risk of GDM.",2020,"There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM.","['obese pregnant women', ""We searched the Cochrane Database of Systematic Reviews (6 August 2019) with key words 'gestational diabetes' OR 'GDM"", 'women who were pregnant or planning a pregnancy, irrespective of their GDM risk status', '11 Cochrane Reviews (71 trials, 23,154 women) with data on GDM', 'women from developing gestational diabetes mellitus']","['heparin, aspirin, leukocyte immunisation or IgG', 'vitamin D + calcium + other minerals versus calcium ', 'vitamin D + calcium supplementation versus placebo', 'Omega-3-fatty acid supplementation and universal screening', 'metformin', 'fatty acid supplementation', 'Diet and exercise', 'exercise and diet, supplementation with myo-inositol, supplementation with vitamin D and metformin', 'vitamin D supplementation', 'placebo']","['diet, exercise, a combination of diet and exercise, dietary supplements, pharmaceuticals, and management of other health problems in pregnancy', 'risk of GDM']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",23154.0,0.298979,"There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Griffith', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Moore', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'School of Interprofessional Health Studies, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Middleton', 'Affiliation': 'Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012394.pub3']
1417,32533243,Anodal transcranial direct current stimulation enhances strength training volume but not the force-velocity profile.,"PURPOSE


This study aimed to explore the acute effect of transcranial direct current stimulation (tDCS) on the force-velocity relationship, strength training volume, movement velocity, and ratings of perceived exertion.
METHODS


Fourteen healthy men (age 22.8 ± 3.0 years) were randomly stimulated over the dorsolateral prefrontal cortex with either ANODAL, CATHODAL or SHAM tDCS for 15 min at 2 mA. The one-repetition maximum (1RM) and force-velocity relationship parameters were evaluated during the bench press exercise before and after receiving the tDCS. Subsequently, participants completed a resistance training session consisting of sets of five repetitions with 1 min of inter-set rest against the 75%1RM until failure.
RESULTS


No significant changes were observed in the 1RM or in the force-velocity relationship parameters (p ≥ 0.377). The number of repetitions was higher for the ANODAL compared to the CATHODAL (p = 0.025; ES = 0.37) and SHAM (p = 0.009; ES = 0.47) conditions. The reductions of movement velocity across sets were lower for the ANODAL than for the CATHODAL and SHAM condition (p = 0.014). RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions. No significant differences between the CATHODAL and SHAM conditions were observed for any variable.
CONCLUSION


The application of ANODAL tDCS before a resistance training session increased training volume, enabled the maintenance of higher movement velocities, and reduced RPE values. These results suggest that tDCS could be an effective method to enhance resistance-training performance.",2020,RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions.,['Fourteen healthy men (age 22.8\u2009±\u20093.0\xa0years'],"['transcranial direct current stimulation (tDCS', 'SHAM tDCS', 'Anodal transcranial direct current stimulation enhances strength training', 'tDCS']","['higher movement velocities, and reduced RPE values', 'repetition maximum (1RM) and force-velocity relationship parameters', 'reductions of movement velocity', 'number of repetitions', 'RPE values', 'force-velocity relationship, strength training volume, movement velocity, and ratings of perceived exertion']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",14.0,0.0394359,RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alix-Fages', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sport Sciences and Physical Conditioning, Faculty of Education, Universidad Catolica de la Santisima Concepcion, Concepción, Chile.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Calderón-Nadal', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Colomer-Poveda', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernández-Del-Olmo', 'Affiliation': 'Department of Education, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Márquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain. gmarquez@ucam.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04417-2']
1418,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1419,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1420,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119']
1421,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1422,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763']
1423,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE


Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
METHODS


In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
RESULTS


A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
CONCLUSIONS


Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
TRIAL REGISTRATION


Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012']
1424,32540685,"Impact of the group intervention ""Accept Voices©"" for the management of auditory hallucinations.","AIM OF THE STUDY


The objective of this study was to evaluate the potential impact of a third wave CBT group intervention for the management of auditory hallucinations in patients with schizophrenia.
METHOD


38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on acceptance and engagement therapy (ACT). The study followed a repeated single case experimental design (type A-B-A) based on the principle of a control phase followed by an intervention phase and a follow-up phase of similar duration. The various measurements were administered during the control phase, at pre-/post-group and six weeks after the last group session.
RESULTS


The results show a significant decrease in auditory hallucinations, as measured by the PSYRATS scale, during the treatment and follow-up phase, compared to the control phase. In addition, the participants saw significant reductions in depressive and anxious symptomatology (assessed with CDSS and SEAS), and increases in coping and acceptance in regards to voices (assessed using a study scale and VAAS). The level of Malevolence beliefs about voices (measured with BAVQ-R) also decreased significantly.
CONCLUSIONS


A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.",2020,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","['patients with schizophrenia', '38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on']","['acceptance and engagement therapy (ACT', 'CBT group intervention']","['depressive and anxious symptomatology', 'auditory hallucinations', 'level of Malevolence beliefs about voices (measured with BAVQ-R', 'coping and acceptance', 'intensity of auditory hallucinations, depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",38.0,0.0263279,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langlois', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France. Electronic address: thomas.langlois@univ-tlse2.fr.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourcier', 'Affiliation': 'CHU Toulouse Purpan, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'Centre médical la Villanelle, Cornebarrieu, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Université de Montréal, Montréal, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2020.113159']
1425,32540720,Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis.,"OBJECTIVE


The gait recovery in spinal cord injury (SCI) seems to be partially related to the reorganization of cerebral function; however, the neural mechanisms and the respective biomarkers are not well known. This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI. We tested this hypothesis at baseline in SCI subjects and also in response to cortical stimulation with transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT).
METHODS


In this neurophysiological analysis of a randomized controlled trial, thirty-nine patients with incomplete SCI were included. They received 30 sessions of either active or sham anodal tDCS over the primary motor area for 20 min combined with RAGT. We analyzed the Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II). Univariate and multivariate linear/logistic regression analyses were performed to identify the predictors of gait function and recovery.
RESULTS


Consistent with our hypothesis, we found that in the sensorimotor area: (1) Anodal tDCS combined with RAGT can modulate high-beta EEG oscillations power and enhance gait recovery; (2) higher high-beta EEG oscillations power at baseline can predict baseline gait function; (3) high-beta EEG oscillations power at baseline can predict gait recovery - the higher power at baseline, the better gait recovery; (4) decreases in relative high-beta power and increases in beta power decrease during walking are associated with gait recovery.
CONCLUSIONS


Enhanced EEG beta oscillations in the sensorimotor area in SCI subjects may be part of a compensatory mechanism to enhance local plasticity. Our results point to the direction that interventions enhancing local plasticity such as tDCS combined with robotic training also lead to an immediate increase in sensorimotor cortex activation, improvement in gait recovery, and subsequent decrease in high-beta power. These findings suggest that beta-band oscillations may be potential biomarkers of gait function and recovery in SCI.
SIGNIFICANCE


These findings are significant for rehabilitation in SCI patients, and as EEG is a portable, inexpensive, and easy-to-apply system, the clinical translation is feasible to follow better the recovery process and to help to individualize rehabilitation therapies of SCI patients.",2020,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"['thirty-nine patients with incomplete SCI were included', 'spinal cord injury patients', 'SCI subjects', 'spinal cord injury (SCI', 'SCI patients']","['active or sham anodal tDCS over the primary motor area for 20\xa0min combined with RAGT', 'transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT']","['high-beta EEG oscillations power and enhance gait recovery', 'Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II', 'gait recovery', 'sensorimotor cortex activation']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",39.0,0.0972225,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Simis', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud. Lima, Peru.'}, {'ForeName': 'Linamara R', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.04.166']
1426,32560485,Real-World Setting Cost-Effectiveness Analysis Comparing Three Therapeutic Schemes of One-Year Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer from the Cyprus NHS Payer Perspective.,"INTRODUCTION


This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data.
METHODS


Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women.
RESULTS


The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively).
CONCLUSIONS


The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.",2020,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","['HER2-positive early female breast cancer in comparison to chemotherapy alone', 'female HER2-positive early breast cancer', '900 women']","['Trastuzumab', 'adjuvant trastuzumab']","['quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY', 'cost-effective']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0166592,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","[{'ForeName': 'Savvas S', 'Initials': 'SS', 'LastName': 'Ioannou', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}, {'ForeName': 'Yiola', 'Initials': 'Y', 'LastName': 'Marcou', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kakouri', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Talias', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}]",International journal of environmental research and public health,['10.3390/ijerph17124339']
1427,32560526,The Application of Structural Retinal Biomarkers to Evaluate the Effect of Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant on Treatment of Diabetic Macular Edema.,"BACKGROUND


The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME).
METHODS


156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis ® ) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann-Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement.
RESULTS


In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height ( p -value = 0.03) and HRS ( p -value = 0.01) was documented.
CONCLUSIONS


Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.",2020,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","['156 treatment-naïve patients with DME', 'Diabetic Macular Edema', 'patients with diabetic macular edema (DME']","['DME', 'dexamethasone', 'ranibizumab 0.5 mg (Lucentis ® ', 'ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers', 'Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant', 'Ranibizumab and dexamethasone', 'ranibizumab', 'intravitreal implant of dexamethasone 0.7 mg (Ozurdex ® ']","['central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN', 'possible OCT biomarker (CRT, ICR, CT, SND, HRS', 'SDN height', 'BCVA', 'Best-corrected visual acuity (BCVA) and swept source-OCT']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C2702454', 'cui_str': 'Dexamethasone Drug Implant'}, {'cui': 'C1299681', 'cui_str': 'Intravitreal implant'}, {'cui': 'C2702453', 'cui_str': 'Dexamethasone 0.7 MG'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0520724', 'cui_str': 'Retinal cyst'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0025925', 'cui_str': 'Mouse, Inbred ICR'}, {'cui': 'C0574347', 'cui_str': 'Sindhi language'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449416', 'cui_str': 'Source'}]",156.0,0.03862,"In both groups, BCVA improved ( p -value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed.","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Ceravolo', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Giovanni William', 'Initials': 'GW', 'LastName': 'Oliverio', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Bhatti', 'Affiliation': 'Glangwili General Hospital Carmarthen, Wales SA31 2AF, UK.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rejdak', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Mario Damiano', 'Initials': 'MD', 'LastName': 'Toro', 'Affiliation': 'Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University of Lublin, 20079 Lublin, Poland.'}, {'ForeName': 'Costantino John', 'Initials': 'CJ', 'LastName': 'Trombetta', 'Affiliation': 'Institute of Ophthalmology, Department of Biomedical Sciences, University of Messina, 98124 Messina, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10060413']
1428,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
1429,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION


Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
1430,32561603,Combination of human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ treatment synergistically improves the clinical outcomes of patients with rheumatoid arthritis.,"OBJECTIVES


To clarify the key role of circulating interferon-γ (IFN-γ) and to improve the clinical efficacy of mesenchymal stem cell (MSC) transplantation (MSCT) in patients with rheumatoid arthritis (RA).
METHODS


Study of wild-type or IFN-γR -/-  MSCT was first evaluated in a murine model of collagen-induced arthritis (CIA) following which a phase 1/2 randomised controlled study was conducted in 63 patients with RA who responded poorly to regular clinical treatments. Subjects were randomly assigned to an MSCT monotherapy group (n=32) or an MSCT plus recombinant human IFN-γ treatment group (n=31), with 1 year of follow-up. The primary end points consisted of efficacy as assessed as good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates.
RESULTS


In the murine studies, wild-type MSCT significantly improved the clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage. Transitioning from the murine to the clinical study, the 3-month follow-up results showed that the efficacy and ACR20 response rates were attained in 53.3% patients with MSCT monotherapy and in 93.3% patients with MSCT combined with IFN-γ treatment (p<0.05). No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
CONCLUSIONS


The results of this study show that IFN-γ is a key factor in determining the efficacy of MSCT in the treatment of RA, and that an MSC plus IFN-γ combination therapeutic strategy can greatly improve the clinical efficacy of MSC-based therapy in RA patients.",2020,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","['RA patients', '63 patients with RA who responded poorly to regular clinical treatments', 'patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', 'Study of wild-type or']","['circulating interferon-γ (IFN-γ', 'IFN-γ', 'IFN-γR -/-  MSCT', 'MSCT monotherapy', 'mesenchymal stem cell (MSC) transplantation (MSCT', 'human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ', 'MSCT plus recombinant human IFN-γ treatment']","['efficacy and ACR20 response rates', 'clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage', 'good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257990', 'cui_str': 'Stem Cell Transplantation, Mesenchymal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0170509', 'cui_str': 'CyADIC protocol'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",63.0,0.0328702,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Mengwei', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Force Health Team of 61365 Troops of the Chinese People's Liberation Army, Tianjin, China.""}, {'ForeName': 'Luoquan', 'Initials': 'L', 'LastName': 'Ao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bellanti', 'Affiliation': 'Departments of Pediatrics and Microbiology-Immunology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Song Guo', 'Initials': 'SG', 'LastName': 'Zheng', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Ohio State University College of Medicine and Wexner Medical Center, Columbus, Ohio, USA xiangxu@tmmu.edu.cn SongGuo.Zheng@osumc.edu.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China xiangxu@tmmu.edu.cn SongGuo.Zheng@osumc.edu.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217798']
1431,32562747,Effects of an 8-week resistance training intervention on plantar flexor muscle quality and functional capacity in older women: A randomised controlled trial.,"The present study examined 8 weeks of resistance training and its effects on muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity in older women. Moreover, we tested if changes in muscle quality were associated with functional capacity. Twenty-four older women (66.3 ± 5.8 years; 69.0 ± 3.0 kg; 25.3 ± 1.4 kg·m -2 ) were recruited to the study. After completion of the baseline assessment, participants were randomly assigned to either the resistance training (RET, n = 12) or an active control group (CTR, n = 12). Muscle quality was evaluated through muscle echo intensity (MQ EI ) and specific tension (MQ ST ). Muscle thickness, unilateral plantar flexor muscle strength and functional tests were evaluated at baseline and after the training period. After 8 weeks, both MQ EI  and MQ ST  did not respond to the intervention. Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05). Finally, significant gains in muscle hypertrophy were observed in the RET group (P < 0.01), while muscle strength failed to change significantly (P > 0.05). In conclusion, a resistance training program provided significant benefits in the stair climb test, unrelated to plantar flexor-derived muscle quality measures as previously demonstrated in quadriceps femoris.",2020,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","['older women', 'Twenty-four older women (66.3\u202f±\u202f5.8\u202fyears; 69.0\u202f±\u202f3.0\u202fkg; 25.3\u202f±\u202f1.4\u202fkg·m -2 ']","['8-week resistance training intervention', 'resistance training (RET, n\u202f=\u202f12) or an active control', 'resistance training']","['stair climb performance', 'Muscle quality', 'plantar flexor-derived muscle quality', 'muscle quality', 'plantar flexor muscle quality and functional capacity', 'Muscle thickness, unilateral plantar flexor muscle strength and functional tests', 'muscle hypertrophy', 'muscle strength', 'muscle echo intensity (MQ EI ) and specific tension (MQ ST ', 'muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0161992,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia. Electronic address: p.lopezda@our.ecu.edu.au.'}, {'ForeName': 'Brendan James', 'Initials': 'BJ', 'LastName': 'Crosby', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bruna Patrícia', 'Initials': 'BP', 'LastName': 'Robetti', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Douglas Jean Preussler', 'Initials': 'DJP', 'LastName': 'Turella', 'Affiliation': 'Centro Clínico UCS, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Thaís Andréia Schepa', 'Initials': 'TAS', 'LastName': 'Weber', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Morgana Lima', 'Initials': 'ML', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111003']
1432,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
1433,32533797,Comparison of a web-push survey research protocol with a mailed paper and pencil protocol in the Monitoring the Future panel survey.,"AIMS


The experiment tested the effects of a web-push survey research protocol, compared with the standard mailed paper-and-pencil protocol, among young adults aged 19-30 years in the 'Monitoring the Future' (MTF) longitudinal study.
DESIGN, SETTING AND PARTICIPANTS


The US-based MTF study has measured substance use trends among young adults in panel samples followed biennially, using consistent mailed survey procedures from 1977 to 2017. In 2018, young adult participants in the MTF longitudinal component scheduled to be surveyed at ages 19-30 in 2018 (from high school senior cohorts of 2006-17, n = 14 709) were randomly assigned to receive the standard mail/paper survey procedures or new web-push procedures.
MEASUREMENTS


Primary outcomes were responding to the survey and prevalence estimates for past 30-day use of alcohol, cigarettes, marijuana and illicit drugs.
FINDINGS


The web-push response rate was 39.07% [95% confidence interval (CI) = 37.889, 40.258]; this was significantly better than the standard MTF response rate of 35.12% (95% CI = 33.964, 36.285). After adjusting for covariates, the web-push condition was associated with a 19% increase in the odds of responding compared with standard MTF (adjusted odds ratio = 1.188; 95% CI = 1.096, 1.287). Substance use prevalence estimates were very similar and differences became negligible when using attrition weights and controlling for socio-demographic characteristics.
CONCLUSIONS


The web-push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future panel study, without substantially affecting estimates of substance use once attrition weights and socio-demographic variables were factored in.",2020,"The Web-Push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future (MTF) panel study, without substantially affecting estimates of substance use once attrition weights and sociodemographic variables were factored in.","['In 2018, young adult participants in the MTF longitudinal component scheduled to be surveyed at ages 19-30 in 2018 (from high school senior cohorts of 2006-2017, N=14,709', 'young adults in panel samples followed biennially, using consistent mailed survey procedures from 1977 to 2017', ""young adults aged 19 to 30 in the 'Monitoring the Future' (MTF) longitudinal study""]",['standard mail/paper survey procedures or new Web-Push procedures'],"['Web-Push response rate', 'responding to the survey and prevalence estimates for past 30-day use of alcohol, cigarettes, marijuana, and illicit drugs', 'response rate', 'standard MTF response rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",14709.0,0.0644472,"The Web-Push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future (MTF) panel study, without substantially affecting estimates of substance use once attrition weights and sociodemographic variables were factored in.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Parks', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Laetz', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Schulenberg', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15158']
1434,32533796,Attachment & Child Health (ATTACH) pilot trials: Effect of parental reflective function intervention for families affected by toxic stress.,"Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment. Parental reflective function-parents' capacity to understand their own and their child's mental states and thus regulate their own feelings and behavior toward their child-may buffer the negative effects of toxic stress on attachment. Our objective was to test the effectiveness of the Attachment and Child Health (ATTACH) intervention, focusing on improving reflective function and children's attachment security, for at-risk mothers and children <36 months of age. Three pilot studies were conducted with women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter. Randomized control trial (n = 20, n = 10 at enrollment) and quasi-experimental (n = 10 at enrollment) methods tested the effect of the ATTACH intervention on the primary outcome of reflective function scores, from transcribed Parent Development Interviews. Our secondary outcome was children's attachment patterns from Ainsworth's Strange Situation Procedure. Despite some attrition, mixed methods analysis of covariance and t tests revealed significant differences in maternal, child, and overall reflective function, with moderate effect sizes. While more children whose mothers received the ATTACH program were securely attached posttreatment, as compared with controls, significant differences were not observed, which may be due to missing observations (n = 5 cases). Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.",2020,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"['risk mothers and children <36 months of age', 'families affected by toxic stress', 'women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter']","['parental reflective function intervention', 'ATTACH intervention', 'Attachment and Child Health (ATTACH) intervention']","['Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0206072', 'cui_str': 'Family Violence'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0582758', 'cui_str': 'Insecure attachment'}]",,0.0662825,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Letourneau', 'Affiliation': 'Faculty of Nursing and Cumming School of Medicine, Departments of Pediatrics, Psychiatry, & Community Health Sciences, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Anis', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ntanda', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Novick', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}]",Infant mental health journal,['10.1002/imhj.21833']
1435,32538796,Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study.,"BACKGROUND


Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.
OBJECTIVE


The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes.
METHODS


We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use.
RESULTS


Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.
CONCLUSIONS


Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.",2020,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"['patients with chronic diseases to self-manage their health', 'people living with chronic illnesses', 'Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions']",['video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app'],"['self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms', 'overall health and long-term symptom management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",39.0,0.0429502,Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers.,"[{'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Porras', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Flynn', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'School of Nursing, Columbia University, New York, NY, United States.'}]",Journal of medical Internet research,['10.2196/17708']
1436,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1437,32540584,The effect of injection volume on long-term outcomes of US-guided subacromial bursa injections.,"PURPOSE


Limited data exist on the efficacy of high- compared to low-volume US-guided corticosteroid injections (CI) in the subacromial-subdeltoid (SA-SD) bursa. Our purpose was to compare the short- and long-term efficacy of low- and high-volume injections, by using a capacity reference of SA-SD bursa volume, as assessed on cadaveric specimens.
METHOD


Within two years, 136 patients (63 males, 73 females; mean age: 46.11 ± 10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included. Patients were randomly assigned to low-volume (1 mL triamcinolone acetonide/40 mg) or high-volume (1 mL triamcinolone acetonide/40 mg, 9 mL anaesthetic agents) groups (67 and 69 patients, respectively). Visual Analogue Scores (VAS) were recorded at baseline, 30 min, 3 weeks, 3 months, 6 months and 1 year post-treatment. Predictors of complete recovery (VAS ≤ 2) at 1 year were analysed with multivariate Cox regression analysis. SA-SD bursa cadaveric dissection in 10 specimens was performed for volume assessment.
RESULTS


Injection volume was the only predictor of complete pain resolution at 1 year. High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001). Mean VAS scores at baseline and subsequent time-points were 6, 2.6, 2.2, 2, 1.6 and 1 for the high-volume and 7.8, 7.3, 4.7, 3.2, 2.5 and 1.8 for the low-volume group, respectively (P < .001, at all time-points). Cadaveric measurements showed a minimum SA-SD bursa volume of approximately 6.9 mL.
CONCLUSIONS


High-compared to low-volume US-guided CI are superior for achieving early pain recovery.",2020,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","['136 patients (63 males, 73 females; mean age: 46.11\u202f±\u202f10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included']","['US-guided subacromial bursa injections', 'low-volume US-guided corticosteroid injections (CI', 'low- and high-volume injections', 'triamcinolone acetonide/40\u202fmg) or high-volume (1\u202fmL triamcinolone acetonide/40\u202fmg, 9\u202fmL anaesthetic agents']","['minimum SA-SD bursa volume', 'complete pain resolution', 'chances of early pain recovery', 'Visual Analogue Scores (VAS', 'Mean VAS scores']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107082,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","[{'ForeName': 'Michail E', 'Initials': 'ME', 'LastName': 'Klontzas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Advanced Hybrid Imaging Systems, Institute of Computer Science, Foundation for Research and Technology (FORTH), 100 N. Plastira str., Voutes, 70013, Heraklion, Crete, Greece.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Vassalou', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, General Hospital of Sitia, Xserokamares, 72300, Sitia, Lasithi, Crete, Greece. Electronic address: vassalou.e@hotmail.com.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'University of Thessaly, Faculty of Medicine, Department of Anatomy Mezourlo Viopolis, 41222, Larissa, Greece.'}, {'ForeName': 'Apostolos H', 'Initials': 'AH', 'LastName': 'Karantanas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, Medical School, University of Crete, Voutes, 71110, Heraklion, Greece.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109113']
1438,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179']
1439,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636']
1440,32540838,COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study.
OBJECTIVE


In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study.
METHODS


The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8"" step, and a large-print 8"" × 11"" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months.
RESULTS


The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021.
CONCLUSIONS


This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18415.",2020,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"['325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments', 'participants with MS who would otherwise have discontinued the study', '759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 820', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'adults with MS']","['synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized', 'comprehensive exercise/rehabilitation services', 'alternative medicine (CAM) intervention', 'teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8"" step, and a large print 8""x11"" paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant']","['resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and Berg Balance Scale']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C3881002', 'cui_str': 'Mini disc'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",759.0,0.0382581,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Division of Pediatric Rehabilitation Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pounds', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Tracy', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Riser', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}]",JMIR research protocols,['10.2196/18415']
1441,32541370,Can Treatment With Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial.,"PRECIS


Citicoline eyedrops in patients with progressing glaucoma.
PURPOSE


This study aimed to test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mm Hg or less.
DESIGN


This was a randomized, double-masked, placebo-controlled, multicenter 3-year study.
OUTCOMES


The outcomes studied were difference in the visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression and difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years.
METHODS


Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5 dB/y in the 2 years before enrollment despite IOP ≤18 mm Hg were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent a visual field examination with 24-2 and 10-2 strategies and RNFL assessment. Analysis of variance and linear models were used to test the differences between groups.
RESULTS


Eighty patients were randomized in the trial. The mean 3-year rates of progression were -1.03 (2.14) dB in the citicoline group and -1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and -0.41 (3.45) dB in the citicoline group and -2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average, patients receiving citicoline eyedrops lost 1.86 μm of RNFL in 3 years, versus 2.99 μm in the placebo group (P=0.02).
CONCLUSIONS


Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18 mm Hg.",2020,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"['y in the 2 years before enrolment despite IOP ≤18▒mmHg', 'Eighty patients', 'patients with progressing glaucoma', 'Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒', 'patients with progressing glaucoma despite IOP ≤18▒mmHg', 'patients with worsening of damage and IOP 18 mmHg or less']","['Placebo', 'citicoline eyedrops or placebo', 'citicoline eyedrops', 'Citicoline Eyedrops', 'PRECIS\n\n\nCiticoline eyedrops', 'citicoline eyedrops to intraocular pressure (IOP) -lowering treatment', 'placebo']","['disease progression', 'visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.500531,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Iester', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tranchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottobelli', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Coco', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Calcatelli', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ancona', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cirafici', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Manni', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001565']
1442,32534724,The Effectiveness of a Time Management Workshop on Job Stress of Nurses Working in Emergency Departments: An Experimental Study.,"INTRODUCTION


One of the main risk factors for poor health is a high level of job stress. Time management skills can greatly reduce job stress. The current study aimed to evaluate the effectiveness of a one-time management training workshop on job stress among nurses working in emergency departments.
METHODS


This randomized experimental study was carried out with 80 nurses working in emergency departments affiliated with a university of medical sciences. The intervention was an 8-hour workshop on time management. Pre- and posttest data were collected by demographic questionnaire and an occupational stress inventory before and 1 month after intervention. Data were analyzed using descriptive, chi-square, t test, Fisher exact, and analysis of covariance statistics.
RESULTS


The mean of job stress in the intervention group increased after the intervention (186.22, SD = 22.97) from baseline (182.52, SD = 34.39) compared with the mean of job stress in the control group (204.42, SD = 22.42) and (204.35, SD = 22.45). The control group had a significantly higher job stress score before the intervention (t = -3.37, P = 0.001). There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
DISCUSSION


The time management skills training program did not reduce the moderate-high levels of job stress of nurses in emergency departments. Addressing other sources of job stress, besides time management, is needed.",2020,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","['80 nurses working in emergency departments affiliated with a university of medical sciences', 'nurses working in emergency departments', 'Job Stress of Nurses Working in Emergency Departments']","['one-time management training workshop', 'Time Management Workshop']","['job stress score', 'job stress scores', 'job stress', 'mean of job stress', 'moderate-high levels of job stress']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]","[{'cui': 'C0556514', 'cui_str': 'Time management training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.0212648,"There was no statistically significant difference between the intervention and control group in job stress scores after intervention (t = -3.56, P = 0.77).
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Karbakhsh Ravari', 'Affiliation': ''}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': ''}, {'ForeName': 'Monirsadat', 'Initials': 'M', 'LastName': 'Nematollahi', 'Affiliation': ''}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.013']
1443,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981']
1444,32543290,Effect of fully immersive virtual reality treatment combined with exercise in fibromyalgia patients: a randomized controlled trial.,"This trial was designed to evaluate the effects of fully immersive virtual reality (IVR) treatment combined with exercise training in fibromyalgia patients. Twenty patients were randomized into exercise group (EG) or IVR combined with exercise group (Exercise+IVR). The EG had combined exercise training consisted of 30 minutes of aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR, twice a week for 8 weeks. Visual analogue scale for pain, Modified Sensory Organization Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life were used for evaluation. Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores improved significantly in both groups ( p  < .05). Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity, and mental component of quality of life ( p  < .05). IVR treatment may be an effective method as an adjunctive therapy with other exercise trainings in fibromyalgia.",2020,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","['fibromyalgia patients', 'Fibromyalgia Patients', 'Twenty patients']","['Fully Immersive Virtual Reality Treatment Combined with Exercise', 'aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR', 'fully immersive virtual reality (IVR) treatment combined with exercise training', 'exercise group (EG) or IVR combined with exercise group (Exercise+IVR']","['EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05', 'Visual analogue scale for pain, Modified Sensory Organisation Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life', 'Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0587617,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University , Ankara, Turkey.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Akcali', 'Affiliation': 'Faculty of Medicine, Department of Algology, Gazi University , Ankara, Turkey.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2020.1772900']
1445,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
1446,32537715,Assessment of effects of repeated oral doses of fedratinib on inhibition of cytochrome P450 activities in patients with solid tumors using a cocktail approach.,"PURPOSE


Fedratinib, an oral selective kinase inhibitor with activity against both wild type and mutationally activated Janus kinase 2, has been approved for the treatment of adult patients with intermediate-2 or high-risk myelofibrosis by the US Food and Drug Administration. In vitro studies indicated that fedratinib was an inhibitor of several cytochrome P450 (CYP) enzymes. The primary objective of this study was to evaluate the effects of repeated doses of fedratinib on the activity of CYP2D6, CYP2C19, and CYP3A4 in patients with solid tumors using a CYP probe cocktail.
METHODS


An open-label, one-sequence, two-period, two-treatment crossover study was conducted. Patients were administered a single oral dose cocktail of metoprolol (100 mg), omeprazole (20 mg), and midazolam (2 mg) used as probe substrates for CYP2D6, CYP2C19, and CYP3A4 enzyme activities, respectively, without fedratinib on Day -1 or with fedratinib on Day 15.
RESULTS


Coadministration of 500 mg once-daily doses of fedratinib for 15 days increased the mean area under the plasma concentration-time curve from time zero to infinity following a single-dose cocktail containing metoprolol (CYP2D6 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate) by 1.77-fold (90% confidence interval [CI] 1.27-2.47) for metoprolol, 2.82-fold (90% CI 2.26-3.53) for omeprazole, and 3.84-fold (90% CI 2.62-5.63) for midazolam, respectively. The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
CONCLUSION


Fedratinib is a weak inhibitor of CYP2D6, and a moderate inhibitor of CYP2C19 and CYP3A4. These results serve as the basis for dose modifications of these CYP substrate drugs when co-administered with fedratinib.",2020,"The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
","['patients with solid tumors using a CYP probe cocktail', 'patients with solid tumors using a cocktail approach', 'adult patients with intermediate-2 or high-risk myelofibrosis']","['omeprazole', 'metoprolol (CYP2D6 substrate), omeprazole (CYP2C19 substrate), and midazolam ', 'metoprolol', 'midazolam']","['cytochrome P450 activities', 'mean area under the plasma concentration-time curve', 'mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0057223', 'cui_str': 'Cytochrome p450 CYP2D6 enzyme'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}]",,0.0345666,"The mean plasma Day 14/Day 1 ratio of 4β-hydroxycholesterol, an endogenous biomarker of CYP3A4 activity, was 0.59 (90% CI 0.54-0.66), suggesting a net inhibition of CYP3A4 by fedratinib.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'LoRusso', 'Affiliation': 'Yale Cancer Center, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Olszanski', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rixe', 'Affiliation': 'Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, Summit, NJ, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04102-3']
1447,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism.
PATIENTS AND METHODS


Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3.
RESULTS


The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001).
CONCLUSION


The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092']
1448,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
1449,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND


People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown.
OBJECTIVE


To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization.
DESIGN


A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469).
METHODS


A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups.
RESULTS


Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups.
CONCLUSION


Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641']
1450,32568065,Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT.,"BACKGROUND


Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people.
OBJECTIVES


The objectives were to determine whether or not oral bicarbonate therapy improves physical function, quality of life, markers of renal function, bone turnover and vascular health compared with placebo in older people with chronic kidney disease and mild acidosis; to assess the safety of oral bicarbonate; and to establish whether or not oral bicarbonate therapy is cost-effective in this setting.
DESIGN


A parallel-group, double-blind, placebo-controlled randomised trial.
SETTING


The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals.
PARTICIPANTS


Participants were adults aged ≥ 60 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of < 22 mmol/l.
INTERVENTIONS


Eligible participants were randomised 1 : 1 to oral sodium bicarbonate or matching placebo. Dosing started at 500 mg three times daily, increasing to 1 g three times daily if the serum bicarbonate concentration was < 22 mmol/l at 3 months.
MAIN OUTCOME MEASURES


The primary outcome was the between-group difference in the Short Physical Performance Battery score at 12 months, adjusted for baseline. Other outcome measures included generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide. All adverse events were recorded, including commencement of renal replacement therapy. For the health economic analysis, the incremental cost per quality-adjusted life-year was the main outcome.
RESULTS


In total, 300 participants were randomised, 152 to bicarbonate and 148 to placebo. The mean age of participants was 74 years and 86 (29%) were female. Adherence to study medication was 73% in both groups. A total of 220 (73%) participants were assessed at the 12-month visit. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 vs. 400). Time to commencement of renal replacement therapy was similar in both groups (hazard ratio 1.22, 95% confidence interval 0.74 to 2.02;  p  = 0.43). Health economic analysis showed higher costs and lower quality of life in the bicarbonate arm at 1 year, with additional costs of £564 (95% confidence interval £88 to £1154) and a quality-adjusted life-year difference of -0.05 (95% confidence interval -0.08 to -0.01); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness.
LIMITATIONS


The trial population was predominantly white and male, limiting generalisability. The increment in serum bicarbonate concentrations achieved was small and a benefit from larger doses of bicarbonate cannot be excluded.
CONCLUSIONS


Oral sodium bicarbonate did not improve a range of health measures in people aged ≥ 60 years with chronic kidney disease category 4 or 5 and mild acidosis, and is unlikely to be cost-effective for use in the NHS in this patient group. Once other current trials of bicarbonate therapy in chronic kidney disease are complete, an individual participant meta-analysis would be helpful to determine which subgroups, if any, are more likely to benefit and which treatment regimens are more beneficial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN09486651 and EudraCT 2011-005271-16. The systematic review is registered as PROSPERO CRD42018112908.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 27. See the NIHR Journals Library website for further project information.",2020,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15).","['Participants were adults aged ≥\u200960 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of <\u200922\u2009mmol/l', 'older people with chronic kidney disease and mild acidosis', 'The mean age of participants was 74 years and 86 (29%) were female', '300 participants were randomised, 152 to', 'patients over 60 years with advanced chronic kidney disease', 'people aged ≥\u200960 years with chronic kidney disease category 4 or 5 and mild acidosis', 'The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals']","['Sodium bicarbonate', 'placebo dominated bicarbonate', 'bicarbonate', 'oral sodium bicarbonate or matching placebo', 'bicarbonate therapy', 'Oral sodium bicarbonate', 'placebo']","['Time to commencement of renal replacement therapy', 'higher costs and lower quality of life', 'physical function', 'Adverse events', 'range of health measures', 'Short Physical Performance Battery score', 'serum bicarbonate concentration', 'generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide', 'physical function, quality of life, markers of renal function, bone turnover and vascular health', 'serum bicarbonate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",300.0,0.463179,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation, Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Huey', 'Initials': 'H', 'LastName': 'Chong', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Hampson', 'Affiliation': ""Department of Clinical Chemistry and Metabolic Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'May Khei', 'Initials': 'MK', 'LastName': 'Hu', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Lamb', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'The Immunoassay Biomarker Core Laboratory, University of Dundee, Dundee, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McNamee', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Plews', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'Ageing Clinical and Experimental Research, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Warwick', 'Affiliation': 'John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24270']
1451,32563863,DHA-enriched fish oil reduces insulin resistance in overweight and obese adults.,"Adipose tissue inflammation is major factor in the development of insulin resistance (IR). Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are anti-inflammatory bioactive lipids, thus may protect against type 2 diabetes (T2D) development. Previous research has demonstrated a sex-dependent association between LCn-3PUFA and T2D, and evidence suggests LCn-3PUFA may improve IR in a sex-dependent manner. This double-blind, randomized, parallel-arm placebo-controlled study aimed to determine whether DHA-enriched fish oil (FO) supplementation improves IR. Sex-dependent effects were assessed by testing for an interaction between sex and treatment in the multiple regression models. Men and women with abdominal obesity (waist circumference: males, ≥102 cm; females, ≥88 cm) and without diabetes were recruited from the community. Participants (age: 50.9 ± 12.7 years, female: 63.7%, BMI: 32.4 ± 6.6 kg/m 2 ) were randomly allocated to either 2 g FO (860 mg DHA + 120 mg EPA) (intervention, n = 38) or 2 g corn oil (CO) /day (control, n = 35) for 12 weeks in a double-blind randomised controlled trial. A fasting blood sample was collected at 0 and 12 weeks for assessment of IR, glucose and blood lipid profile. Sixty-eight participants completed the intervention. Compared with CO (n = 32), FO (n = 36) significantly reduced fasting insulin by -1.62 μIU/L (95%CI: -2.99, -0.26,) (p = 0.021) and HOMA-IR by -0.40 units (95%CI: -0.78, -0.02, p = 0.038). Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001). There was no interaction between sex and treatment for the change in insulin (p-interaction sex*treatment  = 0.816) or HOMA-IR (p-interaction sex*treatment  = 0.825). DHA-enriched FO reduces IR in adults with abdominal obesity, however, sex-dependent differences were not evident in this study.",2020,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"['overweight and obese adults', 'Participants (age: 50.9\xa0±\xa012.7 years, female: 63.7%, BMI: 32.4\xa0±\xa06.6\xa0kg/m 2 ', 'adults with abdominal obesity', 'Men and women with abdominal obesity (waist circumference: males, ≥102\xa0cm; females, ≥88\xa0cm) and without diabetes were recruited from the community']","['FO (860\xa0mg DHA\xa0+\xa0120\xa0mg EPA) (intervention, n\xa0=\xa038) or 2\xa0g corn oil (CO', 'μIU/L (95%CI', 'DHA-enriched FO', 'DHA-enriched fish oil (FO) supplementation', 'CO', 'Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'DHA-enriched fish oil', 'placebo']","['HOMA-IR', 'insulin resistance', 'IR, glucose and blood lipid profile', 'Higher insulin and HOMA-IR', 'fasting insulin']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",68.0,0.375942,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; School of Health Sciences, University of Newcastle, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102154']
1452,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS


Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored.
METHODS


Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
RESULTS


Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05).
CONCLUSIONS


Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Sport Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031']
1453,32563960,Cost-effectiveness of preoperative magnetic resonance imaging to optimize surgery in ductal carcinoma in situ of the breast.,"PURPOSE


Complete surgical excision is the main factor for successful breast-conserving surgery in patients with ductal carcinoma in situ (DCIS) of the breast. Preoperative magnetic resonance imaging (MRI) may allow surgery optimization in this indication. From an economic standpoint, systematic preoperative MRI is associated with an extra cost, which may be offset by a decrease in the number of re-interventions. We performed an economic evaluation alongside IRCIS randomised controlled trial (NCT01112254) to determine whether systematic preoperative MRI in DCIS is a cost-effective strategy.
METHODS


360 patients were included in IRCIS trial. Costs were assessed from the French national health insurance perspective. Resource use was prospectively collected during a 6-month period after randomisation. We estimated the mean cost per averted re-intervention.
RESULTS


Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference: €298 [CI95% : -470; 1063]). There was a non-significant decrease in the rate of re-hospitalisations for positive or close margins (20% in MRI arm versus 27% in No MRI arm, difference -7% [CI95% : -17; 3]). At a willingness to pay of €500 to avert a re-intervention, the probability that MRI strategy is cost-effective was 93%.
CONCLUSION


Systematic preoperative MRI in patients with DCIS of the breast may be a cost-effective strategy. However, the modest clinical benefit associated with such a strategy limits the interest for this procedure in routine practice given the current MRI techniques.",2020,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","['360 patients were included in IRCIS trial', '€298', 'ductal carcinoma in situ of the breast', 'patients with ductal carcinoma in situ (DCIS) of the breast']","['Preoperative magnetic resonance imaging (MRI', 'preoperative magnetic resonance imaging']","['total costs', 'mean cost per averted re-intervention', 'rate of re-hospitalisations']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",360.0,0.132549,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","[{'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Balleyguier', 'Affiliation': 'Gustave Roussy, Department of Medical Imaging, 114 rue Edouard Vaillant, Villejuif, F-94805, France. Electronic address: corinne.balleyguier@gustaveroussy.fr.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109058']
1454,32565122,A Secondary Analysis from a Randomized Trial on the Effect of Plasma Tetrahydrocannabinol Levels on Pain Reduction in Painful Diabetic Peripheral Neuropathy.,"This report examines the association between tetrahydrocannabinol (THC) plasma levels and pain response in a secondary analysis of data from a recent diabetic neuropathy study that demonstrated a dose-dependent reduction in spontaneous and elicited pain at specific time points. A randomized, double-blinded, placebo-controlled crossover study was conducted in sixteen patients with painful diabetic peripheral neuropathy. Subjects participated in four sessions, separated by 2 weeks, during each of which they were exposed to one of four conditions: placebo, or 1%, 4%, or 7% THC dose of cannabis. Baseline assessments of spontaneous and evoked pain were performed. Subjects were then administered aerosolized cannabis or placebo and pain intensity and cognitive testing at specific time points for 4 hours. A blood sample was drawn from the left antecubital vein for plasma assay of total THC at 0, 15, 30, 45, 60, 150, and 240 minutes. Associations were made between pain intensity, cognitive impairment and THC plasma levels in this secondary analysis. Results suggested a U-shaped relation whereby pain ratings are greatest at extreme (low and high) levels of THC. The therapeutic window appeared to fall between 16 ng/mL and 31 ng/mL THC plasma level. There was a significant linear effect of THC on only one out of the three cognitive tests. These findings stress the importance of measuring cannabinoid plasma levels when performing future research. Perspective: This analysis correlating plasma THC levels and pain reduction in diabetic neuropathy suggest a therapeutic window. Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). There was a minor negative linear effect of THC on cognitive function.",2020,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"['sixteen patients with painful diabetic peripheral neuropathy (PDN', 'Painful Diabetic Peripheral Neuropathy']","['THC', 'Plasma Tetrahydrocannabinol Levels', 'aerosolized cannabis or placebo', 'placebo']","['THC levels', 'Pain Reduction', 'cognitive function', 'pain intensity, cognitive impairment and THC plasma levels', 'THC plasma level', 'pain ratings', 'spontaneous and evoked pain', 'THC plasma levels and pain response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",16.0,0.176395,Low and high THC levels had a negative association (no reduction) and THC levels within the window had a positive association (reduction). ,"[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Wallace', 'Affiliation': 'Department of Anesthesiology, School of Medicine, University of California, San Diego, La Jolla, CA. Electronic address: mswallace@ucsd.edu.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Marcotte', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA; Department of Psychiatry, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Hayley Treloar', 'Initials': 'HT', 'LastName': 'Padovano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'Director, Cannabinoid Research, Zynerba Pharmaceuticals, Devon, PA.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.03.003']
1455,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK. Electronic address: ad5173@coventry.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785']
1456,32572017,General Anesthesia Maintained with Sevoflurane versus Propofol in Pediatric Surgery Shorter Than 1 Hour: A Randomized Single-Blind Study.,"BACKGROUND Sevoflurane was compared with propofol for general anesthesia maintenance in pediatric operations lasting less than 1 hour in terms of anesthetic effect and postoperative recovery. MATERIAL AND METHODS Children scheduled for inguinal hernia repair or hydrocele testis repair were randomly assigned to receive general anesthesia maintained with either sevoflurane (n=43) or propofol (n=43). The ilioinguinal nerve was blocked with 1% lidocaine (7 mg/kg) after intravenous administration of ketamine (2 mg/kg). At the end of the surgery in patients receiving sevoflurane, sevoflurane was stopped and a bolus of propofol of 1 mg/kg was administered. RESULTS Sevoflurane was associated with significantly less use of ketamine (35.1±10.6 mg) than was propofol (59.0±28.0 mg; P<0.001). In addition, sevoflurane was associated with a significantly shorter time in the post-anesthesia care unit (52.1±9.0 min) than was propofol (68.8±15.3 min; P<0.001). Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045). However, the 2 groups showed no important differences in other adverse events such as hypoxia, emergence agitation, and additional use of propofol. CONCLUSIONS In pediatric surgery lasting less than 1 hour, anesthesia maintained with sevoflurane was associated with significantly less use of ketamine, shorter postoperative recovery time, and less intraoperative body movement than was propofol.",2020,Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045).,"['Pediatric Surgery Shorter Than 1 Hour', 'Children scheduled for inguinal hernia repair or hydrocele testis repair']","['general anesthesia maintained with either sevoflurane', 'sevoflurane, sevoflurane', 'ketamine', 'lidocaine', 'Sevoflurane versus Propofol', 'Propofol', 'sevoflurane', 'propofol', 'Sevoflurane']","['intraoperative body movement', 'adverse events such as hypoxia, emergence agitation, and additional use of propofol']","[{'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C1720771', 'cui_str': 'Hydrocele'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",,0.0664735,Propofol was associated with a significantly higher incidence of intraoperative body movement (33.3%) than was sevoflurane (13.5%; P=0.045).,"[{'ForeName': 'Guisheng', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923681']
1457,32542695,Differing Effects of Zoledronic Acid on Bone Microarchitecture and Bone Mineral Density in Men Receiving Androgen Deprivation Therapy: A Randomized Controlled Trial.,"Androgen deprivation therapy (ADT) given to men with prostate cancer causes rapid and severe sex steroid deficiency, leading to increased bone remodeling and accelerated bone loss. To examine the effects of a single dose of zoledronic acid on bone microarchitecture, we conducted a 2-year randomized placebo controlled trial in 76 men, mean age (interquartile range [IQR]) 67.8 years (63.8 to 73.9) with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomized to zoledronic acid and 37 to matching placebo. Bone microarchitecture was measured using high-resolution peripheral quantitative computed tomography (HR-pQCT). Using a mixed model, mean adjusted differences (MAD; 95% confidence interval [95% CI]) between the groups are reported as the treatment effect at several time points. Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0 to 15.4], p = 0.21) and tibia (1.9 mg HA/cm 3  [-3.3 to 7.0], p = 0.87). Similarly, there were no between-group differences in other measures of microarchitecture, with the exception of a modest effect of zoledronic acid over placebo in total cortical vBMD at the radius over 12 months (17.3 mgHA/cm 3  [5.1 to 29.5]). In contrast, zoledronic acid showed a treatment effect over 24 months on areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA) at all sites, including lumbar spine (0.10 g/cm 2  [0.07 to 0.13]), p < 0.001), and total hip (0.04 g/cm 2  [0.03 to 0.05], p < 0.001). Bone remodeling markers were initially suppressed in the treatment group then increased but remained lower relative to placebo (MADs at 24 months CTX -176 ng/L [-275 to -76], p < 0.001; P1NP -18 mg/L [-32 to -5], p < 0.001). These findings suggest that a single dose of zoledronic acid over 2 years is ineffective in preventing the unbalanced bone remodeling and severe microstructural deterioration associated with ADT therapy. © 2020 American Society for Bone and Mineral Research.",2020,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","['76 men, mean age [IQR] 67.8\u2009years [63.8;73.9] with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomised to', 'men with prostate cancer', 'men receiving androgen deprivation therapy']","['Androgen deprivation therapy (ADT', 'zoledronic acid', 'zoledronic acid over placebo', 'placebo']","['total cortical vBMD', 'total hip', 'bone microarchitecture and bone mineral density', 'Bone remodeling markers', 'total volumetric bone mineral density (vBMD); radius', 'lumbar spine', 'Bone microarchitecture']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",76.0,0.38584,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","[{'ForeName': 'Ada S', 'Initials': 'AS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hoermann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Tinson', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Milevski', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Daryl Lim', 'Initials': 'DL', 'LastName': 'Joon', 'Affiliation': 'Department of Radiation Oncology, Austin Health, Heidelberg, Australia.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ego', 'Initials': 'E', 'LastName': 'Seeman', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4106']
1458,32542748,"Prospective, randomized trial of treatment for mild ulnar neuropathy at the elbow.",,2020,,['mild ulnar neuropathy at the elbow'],[],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",[],[],,0.0211104,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Podnar', 'Affiliation': 'Institute of Clinical Neurophysiology, Division of Neurology, University Medical Center, Ljubljana, Slovenia.'}]",Muscle & nerve,['10.1002/mus.27005']
1459,32537853,Authors' reply re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0726803,,"[{'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16333']
1460,32528654,Learning to make informed health choices: Protocol for a pilot study in schools in Barcelona.,"Introduction:  The Informed Health Choices (IHC) project has developed learning resources to teach primary school children (10 to 12-year-olds) to assess treatment claims and make informed health choices. The aim of our study is to explore both the students' and teachers' experience when using these resources in the context of Barcelona (Spain).  Methods:  During the 2019-2020 school year, we will conduct a pilot study with 4  th  and 5  th -year primary school students (9 to 11-year-olds) from three schools in Barcelona. The intervention in the schools will include: 1) a workshop with the teachers, and 2) lessons to the students. The data collection will include: 1) assessment of the IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment by the students at the end of the lessons, and 6) assessment of the IHC resources by the teachers at the end of the lessons. We will use  ad hoc  questionnaires and guides to register the data. We will perform a quantitative and qualitative analysis of the data to explore understandability, desirability, suitability, usefulness, facilitators and barriers of the resources. The most relevant results will be discussed and some recommendations on how to use, how to adapt (if needed), and how to implement the IHC resources to this context will be agreed. The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  Ethical considerations:  The study protocol has obtained an approval exemption from the Ethics Committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).",2019,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  ","['schools in Barcelona', 'primary school children (10 to 12-year-olds', 'During the 2019-2020 school year, we will conduct a pilot study with 4  th  and 5  th -year primary school students (9 to 11-year-olds) from three schools in Barcelona']","['IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment', 'Santa Creu']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0303023,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use.  ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez García', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alonso-Coello', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Asso Ministral', 'Affiliation': 'Maternal and Child Health Service, General Subdirectorate of Health Promotion, Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ballesté-Delpierre', 'Affiliation': 'ISGlobal, Hospital Clínic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Canelo Aybar', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'de Britos', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Rodríguez', 'Affiliation': 'Escola Sant Martí, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gallego Iborra', 'Affiliation': 'Andalusian Health Service, Malaga, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Leo Rosas', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Llaquet', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ena Pery', 'Initials': 'EP', 'LastName': 'Niño de Guzmán Quispe', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Pérez-Gaxiola', 'Affiliation': 'Paediatric Hospital of Sinaloa, Sinaloa, Mexico.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Requeijo', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Salas-Gama', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Samsó Jofra', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Terres', 'Affiliation': 'Institut Escola Antaviana, Barcelona, Spain.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Urreta', 'Affiliation': 'Clinical Epidemiology and Research Unit, University Hospital of Donostia, Donostia, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}]",F1000Research,['10.12688/f1000research.21292.3']
1461,31622131,Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31.,"PURPOSE


Recent trials have shown potential benefit of extended adjuvant endocrine therapy and relatively high risk of recurrence (RoR) after 5 years in hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Although risk of late relapse in HR+ HER2- breast cancer is fairly well defined, the risk in HER2-positive (HER2+) breast cancer treated with adjuvant trastuzumab-based chemotherapy remains largely unknown.
METHODS


We included 3,177 patients with HER2+ breast cancer treated with adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment Group N9831 (ClinicalTrials.gov identifier: NCT00005970) and National Surgical Adjuvant Breast and Bowel Project B-31 (ClinicalTrials.gov identifier: NCT00004067) trials.
RESULTS


Overall, HR+ breast cancer was significantly associated with improved recurrence-free survival (RFS) during the first 5 years (hazard ratio, 0.65; 95% CI, 0.56 to 0.77;  P  < .001). Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001). However, there was no significant difference in RFS based on HR status during years 5 to 10 (hazard ratio, 1.32; 95% CI, 0.93 to 1.88;  P  = .12). A comparable degree of trastuzumab benefit was observed in HR+ and HR- breast cancers (  P  for interaction = .87). Furthermore, we observed low RoR in years 5 to 10 among patients with HR+ HER2+ breast cancer: 3.23% in patients without lymph node involvement (N0) and 6.39% in patients with involvement of one to three lymph nodes (N1).
CONCLUSION


The benefit of adjuvant trastuzumab persists for a long time. A distinct pattern of recurrence was observed between HR+ and HR- HER2+ disease but with similar degree of benefit from adjuvant trastuzumab. RoR in years 5 to 10 in HR+ HER2+ breast cancer is low, particularly in patients with N0 or N1 disease.",2019,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","['Patients With HER2-Positive Breast Cancer Receiving', 'patients with N0 or N1 disease', '3,177 patients with HER2+ breast cancer treated with']","['adjuvant trastuzumab', 'adjuvant chemotherapy alone or with trastuzumab from the North Central Cancer Treatment', 'Adjuvant Trastuzumab']","['HR+ and HR- breast cancers', 'cumulative hazard for RFS', 'recurrence-free survival (RFS', 'Incidence of Late Relapses', 'RFS based on HR status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",3177.0,0.040459,"Among patients treated with trastuzumab, cumulative hazard for RFS was lower in patients with HR+ HER2+ breast cancer during the first 5 years (10.96%  v  17.48%; hazard ratio, 0.60; 95% CI, 0.45 to 0.79;  P  < .001).","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Serie', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mashadi-Hossein', 'Affiliation': 'NanoString, Seattle, WA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Colon-Otero', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Pogue-Geile', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Gavin', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'E Aubrey', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00443']
1462,32544572,"A 10-week yoga practice has no effect on cognition, but improves balance and motor learning by attenuating brain-derived neurotrophic factor levels in older adults.","Despite studies investigating the effect of yoga on cognitive and motor functioning in older adults, the effect on dual-task performance and motor learning and the specific mechanisms underlying the positive effect of yoga remain unclear. Thus, the aim of this study was to investigate the effects of yoga on cognition, balance under single- and dual-task conditions, and motor learning. The potential role of brain-derived neurotrophic factor (BDNF) in induced improvement was also explored. Participants aged 60-79 years were randomized to either a control group (n = 15) or a yoga group (n = 18) for a 10-week period. The yoga group received 90-min duration yoga classes two times per week. Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements were assessed. Yoga practice decreased (P < 0.05) the velocity vector of the center of pressure under single- and dual-task conditions, whereas no changes in cognitive performance were observed. Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group. Significant moderate relationships (P < 0.05) between changes in BDNF levels and functional improvements were observed. Thus, 10 weeks of yoga practice resulted in improved balance and learning in the speed-accuracy motor task that were mediated by increased BDNF levels, but had no impact on cognition in older adults.",2020,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","['Participants aged 60-79\u202fyears', 'older adults']","['brain-derived neurotrophic factor (BDNF', 'control group (n\u202f=\u202f15) or a yoga group']","['cognitive performance', 'Yoga practice', 'BDNF levels', 'shorter movement time', 'reaction and movement times during learning', 'velocity vector of the center of pressure under single- and dual-task conditions', 'Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements', 'balance and learning', 'cognition, balance under single- and dual-task conditions, and motor learning', 'BDNF levels and functional improvements', 'faster reaction time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0174528,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","[{'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Čekanauskaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania. Electronic address: agne.cekanauskaite@lsu.lt.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kilikevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}]",Experimental gerontology,['10.1016/j.exger.2020.110998']
1463,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE


Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration.
METHODS


Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period.
RESULTS


A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
CONCLUSIONS


Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212']
1464,32544794,Acute aerobic exercise enhances pleasant compared to unpleasant visual scene processing.,"Although acute aerobic exercise benefits different aspects of emotional functioning, it is unclear how exercise influences the processing of emotional stimuli and which brain mechanisms support this relationship. We assessed the influence of acute aerobic exercise on valence biases (preferential processing of negative/positive pictures) by performing source reconstructions of participants' brain activity after they viewed emotional scenes. Twenty-four healthy participants (12 women) were tested in a randomized and counterbalanced design that consisted of three experimental protocols, each lasting 30 min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST). After each of the protocols, participants viewed negative and positive pictures, during which event-related magnetic fields were recorded. Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset. Brain activity in this cluster showed that a negativity bias at REST (negative > positive picture processing) diminished after the Low-Int condition (positive = negative) and even reversed to a positivity bias after the Mod-Int condition (positive > negative). Thus, acute aerobic exercise of low and moderate intensities induces a positivity bias which is reflected in early, automatic processes.",2020,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"['Twenty-four healthy participants (12 women', ""participants' brain activity after they viewed emotional scenes""]","['Acute aerobic exercise enhances pleasant', 'lasting 30\xa0min: low-intensity exercise (Low-Int); moderate-intensity exercise (Mod-Int); and a seated rest condition (REST', 'acute aerobic exercise']","['valence processing of emotional scenes', 'Brain activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",24.0,0.139816,Analyses revealed that exercise strongly impacted the valence processing of emotional scenes within a widely distributed left hemispheric spatio-temporal cluster between 190 and 310 ms after picture onset.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Institute for Sports Science, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Roesmann', 'Affiliation': 'Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany; Institute for Clinical Psychology, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Junghofer', 'Affiliation': 'Institute for Biomagnetism and Biosignalanalysis, University of Muenster, Muenster, Germany; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Muenster, Muenster, Germany.'}]",Brain and cognition,['10.1016/j.bandc.2020.105595']
1465,32545655,Effect of C242T Polymorphism in the Gene Encoding the NAD(P)H Oxidase p22 phox  Subunit and Aerobic Fitness Levels on Redox State Biomarkers and DNA Damage Responses to Exhaustive Exercise: A Randomized Trial.,"NAD(P)H oxidases (NOXs) constitute a principal source of cellular reactive oxygen species (ROS) and contribute to exercise-induced ROS production in the skeletal muscle. Here, we aimed to investigate the effect of single-bout exhaustive exercise on redox state biomarkers and oxidative DNA damage based on the C242T polymorphism in the gene encoding NOXs subunit p22 phox  ( CYBA ) and aerobic fitness levels. We enrolled 220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110), who were divided into CC genotype and T allele groups through the analysis of the  CYBA  C242T polymorphism. Furthermore, maximum oxygen uptake (VO 2 max) was evaluated to divide subjects into high fitness (HF; 70th percentile for aerobic fitness) and mid-range fitness (MF; 40-60th percentile for aerobic fitness) groups, with a total of 32 subjects assigned to four groups (eight subjects per group): CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF). All subjects performed treadmill running exercise at 85% of VO 2 max until exhaustion. Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM]) were measured in the blood samples obtained immediately before (IBE), immediately after (IAE), and 30 min after exercise (30 MAE). Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05). All groups displayed increased plasma MDA levels at IAE rather than at IBE, with CC + MF being significantly higher than T + HF ( p  < 0.05); only the CC + HF and T + HF groups exhibited a significant reduction at 30 MAE ( p  < 0.05). Moreover, TL at IAE was significantly higher in the CC + MF group than in the T + HF group ( p  < 0.05), and significantly higher in the CC + MF and CC + HF groups than in the T + HF group at 30 MAE ( p  < 0.05). TM was significantly higher in the T + MF than in the T + HF group at IAE ( p  < 0.05) and that of CC + MF was significantly higher than CC + HF and T + HF values at IAE and 30 MAE ( p  < 0.05). These results suggest that single-bout exhaustive exercise could induce peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage. Moreover, high aerobic fitness levels combined with the T allele may protect against exercise-induced redox imbalance and DNA damage.",2020,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","['220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110']","['C242T Polymorphism', 'treadmill running exercise', 'CC + MF', 'CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF', 'single-bout exhaustive exercise']","['peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage', 'plasma MDA levels', 'Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM', 'Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM', 'TM', 'TL at IAE', 'maximum oxygen uptake (VO 2 max']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1272145', 'cui_str': 'Plasma lactate level'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",220.0,0.020247,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","[{'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Exercise Physiology Laboratory, Department of Physical Education, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17124215']
1466,32557838,The Motor skills At Playtime intervention improves children's locomotor skills: A feasibility study.,"BACKGROUND


Interventions are needed to teach fundamental motor skills (FMS) to preschoolers. There is a need to design more practical and effective interventions that can be successfully implemented by non-motor experts and fit within the existing gross motor opportunities such as outdoor free play at the preschool. The purpose of this study was to evaluate the feasibility and efficacy of a non-motor expert FMS intervention that was implemented during outdoor free play, Motor skills At Playtime (MAP).
METHODS


Participants were preschoolers from two Head Start centres (N = 46; M age  = 4.7 ± 0.46 years; 41% boys) and were divided into a MAP (n = 30) or control (outdoor free play; n = 16) group. Children completed either a 1,350-min MAP intervention or control condition (outdoor free play) from January to April of 2018. FMS were assessed before and after each programme using both the Test of Gross Motor Development-3rd Edition and skill outcome measures (running speed, hopping speed, jump distance, throwing speed, kicking speed and catching percentage). Intervention implementation feasibility was measured through daily fidelity checks. Fidelity was evaluated as the percentage of intervention sessions that included all explicit intervention criteria. FMS data were analysed using linear mixed modelling. Models were fit with fixed effects of time and treatment, covariates of sex and height, and a random intercept for each individual.
RESULTS


The non-motor expert was feasibly able to implement MAP with high fidelity (>93%). There was a significant treatment effect for MAP on process and product locomotor FMS (P < 0.05) and a trend for a treatment effect for MAP on total process FMS (P = 0.07).
CONCLUSION


Results support that MAP was successfully implemented by a non-motor expert and led to improvements in children's FMS, especially locomotor FMS.",2020,"There was a significant treatment effect for MAP on process and product locomotor FMS (p< 0.05), and a trend for a treatment effect for MAP on total process FMS (p = 0.07).
",['Participants were preschoolers from two Head Start Centers (N = 46; M age  = 4.7 ± 0.46 years; 41% boys) and were divided into a MAP (n = 30) or control (outdoor free play; n = 16) group'],"['non-motor expert FMS intervention', '1350-minute MAP intervention or control condition (outdoor free play', 'Playtime intervention']","['outdoor free play, Motor skills', ""children's locomotor skills"", 'MAP on process and product locomotor FMS', 'Gross Motor Development-3 rd  Edition (Ulrich, 2019) and skill outcome measures (running speed, hopping speed, jump distance, throwing speed, kicking speed, and catching percentage', 'feasibility and efficacy', 'FMS', 'Motor skills']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517567', 'cui_str': '1350'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0124364,"There was a significant treatment effect for MAP on process and product locomotor FMS (p< 0.05), and a trend for a treatment effect for MAP on total process FMS (p = 0.07).
","[{'ForeName': 'Kara K', 'Initials': 'KK', 'LastName': 'Palmer', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sean K', 'Initials': 'SK', 'LastName': 'Meehan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI, USA.'}]","Child: care, health and development",['10.1111/cch.12793']
1467,32556293,Identification and validation of a novel clinical signature to predict the prognosis in confirmed COVID-19 patients.,"BACKGROUND


This study aims to identify a prognostic biomarker to predict the disease prognosis and reduce the mortality rate of COVID-19, which has caused a worldwide pandemic.
METHODS


COVID-19 patients were randomly divided into training and test groups. Univariate and multivariate Cox regression analyses were performed to identify the disease prognosis signature, which was selected to establish a risk model in the training group. Furthermore, the disease prognosis signature of COVID-19 was validated in the test group.
RESULTS


The signature of COVID-19 was combined with five indicators, namely neutrophil count, lymphocyte count, procalcitonin, older age, and C-reactive protein. The signature stratified patients into high- and low-risk groups with significantly relevant disease prognosis (log-rank test, P<0.001) in the training group. The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001). The area under ROC curve (AUC) showed that the signature of COVID-19 displayed the highest predictive accuracy regarding disease prognosis, which was 0.955 in the training group and 0.945 in the test group. The ROC analysis of both groups demonstrated that the predictive ability of the signature surpassed the use of each of the five indicators alone.
CONCLUSION


The signature of COVID-19 presents a novel predictor and prognostic biomarker for closely monitoring patients and providing timely treatment for those who are severely or critically ill.",2020,The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001).,['COVID-19 patients'],[],"['survival probability', 'area under ROC curve (AUC', 'neutrophil count, lymphocyte count, procalcitonin, older age, and C-reactive protein', 'survival analysis']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",,0.0318789,The survival analysis indicated that the high-risk group displayed substantially lower survival probability than the low-risk group (log-rank test P<0.001).,"[{'ForeName': 'Shangrong', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sanying', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Respiratory Disease, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Disease, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency Medicine, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fangxiong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Laboratory, Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa793']
1468,32554183,The interactive effects of test-retest and methylphenidate administration on cognitive performance in youth with ADHD: A double-blind placebo-controlled crossover study.,"Studies have shown that Methylphenidate (MPH) affects cognitive performance on the neuropsychological tests and clinical symptoms of individuals diagnosed with attention deficit/hyperactivity disorder (ADHD). This study investigated the acute effects of MPH on neuropsychological tests to explore the interaction between MPH and test-retest effects. Twenty youths with ADHD were tested before and after MPH intake in a double-blind placebo-controlled crossover design and compared to twenty matched controls. Participants were tested on a range of standardized tasks including sustained attention to response, N-Back, and Word/Color Stroop. Identical tasks were administered twice each testing day, before and 1 hour after MPH/Placebo administration. Healthy controls were tested similarly with no intervention. Decreases in response time (RT) variability across tasks and in commission errors were found in ADHD after MPH. Conversely, a significant increase in RT variability and increase in omission errors were observed after the placebo. In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively. Test-retest reliability was higher in controls than ADHD. It is suggested that cognitive tests are sensitive objective measures for the assessment of responses to MPH in ADHD but are also affected by repetition and fatigue.",2020,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","['youth with ADHD', 'individuals diagnosed with attention deficit/hyperactivity disorder (ADHD', 'Twenty youths with ADHD']","['Methylphenidate (MPH', 'methylphenidate', 'placebo']","['cognitive performance', 'RT variability and omission errors', 'Test-retest reliability', 'sustained attention to response, N-Back, and Word/Color Stroop', 'RT variability', 'response time (RT) variability across tasks and in commission errors', 'omission errors', 'commission errors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",20.0,0.196672,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Horowitz', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: itaizen@gmail.com.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Avirame', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Naim-Feil', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel; Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Rubinson', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Moses', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': ""Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Child and Adolescent Psychiatry Division, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Levit-Binnun', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}]",Psychiatry research,['10.1016/j.psychres.2020.113056']
1469,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
1470,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1471,32573956,"Safety and Pharmacokinetics of High-Dose TAS-303 in Healthy Japanese Volunteers: A Single-Center, Single-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multiple-Ascending-Dose Study.","Preclinical data of TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7  ] acetate hydrochloride), a noradrenaline reuptake inhibitor, show that it increases urethral contraction in rats and may therefore benefit stress urinary incontinence patients. In this single-blind, randomized, placebo-controlled, parallel-group, multiple-ascending-dose phase 1 study, we evaluated the safety and tolerability of once-daily TAS-303 8, 10, 12, 15, or 18 mg administered for 16 days in healthy subjects. In addition, we investigated the pharmacokinetics and inhibitory effect of TAS-303 on hepatic cytochrome P450 (CYP) 3A activity. Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303 were evaluated. Fifty subjects were randomized: 7 subjects each were assigned to receive TAS-303 8-18 mg, and 3 subjects each were assigned to receive placebo at each dose. The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively. No deaths or serious adverse events occurred. TAS-303 displayed a dose-proportional pharmacokinetic profile across doses of 8-18 mg over the 16-day multiple administration period, and TAS-303 might inhibit hepatic CYP3A activity within this dose range. TAS-303 at a dose of 8-18 mg was confirmed to be safe and tolerable.",2020,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","['healthy subjects', 'Healthy Japanese Volunteers', 'stress urinary incontinence patients', 'Fifty subjects were randomized: 7 subjects each']","['Placebo', 'TAS-303', 'TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7  ] acetate hydrochloride', 'High-Dose TAS-303', 'placebo']","['hepatic cytochrome P450 (CYP) 3A activity', 'deaths or serious adverse events', 'hepatic CYP3A activity', 'safety and tolerability', 'safe and tolerable', 'adverse events and adverse drug reactions', 'urethral contraction', 'Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303', 'Safety and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0058372', 'cui_str': 'Diphenyl'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}]",50.0,0.251432,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","[{'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Hanada', 'Affiliation': 'SOUSEIKAI Sumida Hospital, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.801']
1472,32569172,Unilateral versus bilateral balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures: A randomized controlled trial protocol.,"BACKGROUND


It is currently controversial whether unilateral or bilateral balloon kyphoplasty (BKP) is superior in terms of postoperative outcomes in treatment of osteoporotic vertebral compression fracture (OVCF). In this context, the aim of this study was to prospectively evaluate and compare the radiographic and clinical outcomes of BKP using unilateral and bilateral approaches.
METHODS


This was a randomized controlled study and was approved by the Severance Institutional Review Board in our hospital. The study protocol was designed in accordance with the Declaration of Helsinki guidelines. Patients who complained of chronic back pain secondary to OVCF, which occurred in thoracic lumbar region over 6 months and met the criteria of osteoporosis were the candidates for this procedure. A total of 150 patients were randomized to undergo either unilateral or bipedicular BKP. The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications.
RESULTS


We were able to directly compare the outcomes of unilateral versus bilateral BKP and might reveal a better technique in OVCF.
TRIAL REGISTRATION


this study protocol was registered in Research Registry (researchregistry5543).",2020,"The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications.
","['150 patients', 'osteoporotic vertebral compression fractures', 'Patients who complained of chronic back pain secondary to', 'osteoporotic vertebral compression fracture (OVCF']","['unilateral or bipedicular BKP', 'BKP', 'unilateral or bilateral balloon kyphoplasty (BKP', 'OVCF', 'Unilateral versus bilateral balloon kyphoplasty']","['pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",150.0,0.115195,"The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications.
","[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Minimally Invasive Spine Surgery, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, No.109, Xueyuan Western Road, Wenzhou City, Zhejiang Province, P.R. China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wenfei', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': ''}, {'ForeName': 'Qishan', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020524']
1473,32569239,Efficiency and safety evaluation of prophylaxes for venous thrombosis after gynecological surgery.,"BACKGROUND


In this study, we investigate the incidence of venous thrombosis (VT), and evaluate the effectiveness and safety of 3 major thromboprophylaxes and the potential risk factors for VT in women undergoing surgery for a gynecological malignancy.
METHODS


We performed a randomized controlled trial of 307 patients undergoing laparoscopic surgery for gynecological malignancies at a single institution from January 2016 to October 2017. Patients were divided into 3 groups: one receiving a half dose of low-molecular-weight heparin sodium injection (FLUXUM, Alfa Wassermann, Italy) delivered by injection, one receiving a full dose of FLUXUM, and a third group receiving an Argatroban injection.
RESULTS


None of the patients in our study developed a pulmonary embolism, bleeding, or infectious complications. There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups. None of the patients developed symptomatic VT. The effect of treatment on alanine aminotransferase and aspartate aminotransferase differed between the groups, with a minimal effect in the Argatroban group, and all 3 methods resulted in minimal impairment of renal function. Decreased hemoglobin, elevated levels of D-dimer, and prothrombin time were closely related to thrombogenesis.
CONCLUSION


In conclusion, the incidence of postoperative thrombosis in gynecological malignancy among these Chinese people is not as low as we had originally presumed. Argatroban is not more effective than Parnaparin as a direct thrombin inhibitor, but it has less influence on liver function, which is beneficial for patients undergoing chemotherapy. Hemoglobin, D-dimer, and prothrombin time may be used to predict or detect thrombogenesis.",2020,"There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups.","['venous thrombosis after gynecological surgery', 'women undergoing surgery for a gynecological malignancy', 'patients undergoing chemotherapy', '307 patients undergoing laparoscopic surgery for gynecological malignancies at a single institution from January 2016 to October 2017']","['low-molecular-weight heparin sodium injection (FLUXUM, Alfa Wassermann, Italy) delivered by injection, one receiving a full dose of FLUXUM, and a third group receiving an Argatroban injection', 'prophylaxes', 'Argatroban']","['pulmonary embolism, bleeding, or infectious complications', 'alanine aminotransferase and aspartate aminotransferase', 'rate of deep venous thrombosis (DVT', 'Hemoglobin, D-dimer, and prothrombin time', 'minimal impairment of renal function', 'superficial venous thromboembolism (SVT', 'symptomatic VT', 'Decreased hemoglobin, elevated levels of D-dimer, and prothrombin time']","[{'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0212082', 'cui_str': 'Fluxum'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1828121', 'cui_str': 'Injections'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4255162', 'cui_str': 'argatroban Injection'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",307.0,0.125385,"There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups.","[{'ForeName': 'Ruidi', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Faridah', 'Initials': 'F', 'LastName': 'Nansubuga', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of Vascular Surgery, Hepatic Surgery Center, Department of Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Wencheng', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Kezhen', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Danhui', 'Initials': 'D', 'LastName': 'Weng', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology.'}, {'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology.'}]",Medicine,['10.1097/MD.0000000000020928']
1474,32569934,Metabolic tracking of isoflavones in soybean products and biosamples from healthy adults after fermented soybean consumption.,"Fermentation may enhance the nutritional properties of foods by increasing metabolite bioactivity or bioavailability. This study explored the effect of fermentation on isoflavone bioavailability and metabolism. Isoflavone metabolites were tracked in foods and biospecimens of healthy adults after fermented soybean (FS) or non-fermented soybean (NFS) consumption in a randomized, controlled, crossover intervention study. The change in soybean isoflavones caused by fermentation resulted in faster absorption and higher bioavailability after consumption of FS. Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis. This study suggests that an isoflavone conjugate profile might be a more appropriate marker than total isoflavone levels for discriminating between the consumption of FS and NFS diets.",2020,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","['healthy adults after', 'healthy adults after fermented soybean consumption']","['fermented soybean (FS) or non-fermented soybean (NFS) consumption', 'isoflavones', 'Isoflavone metabolites']","['faster absorption and higher bioavailability', 'urinary level of total isoflavone metabolites', 'metabolite bioactivity or bioavailability', 'isoflavone bioavailability and metabolism']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0552057,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","[{'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Jang', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea; Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heon-Woong', 'Initials': 'HW', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Hyeon-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Freisling', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Jung-Bong', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Choe', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea. Electronic address: swany@korea.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea. Electronic address: orank@ewha.ac.kr.'}]",Food chemistry,['10.1016/j.foodchem.2020.127317']
1475,32570015,Lactobacillus rhamnosus GG and HbA1c in middle age and older adults without type 2 diabetes mellitus: A preliminary randomized study.,"BACKGROUND AND AIMS


Probiotic supplementation improves glycemic control in persons with diabetes and the current study examined whether these benefits extend to healthy individuals.
METHODS


The current study was a 90-day placebo-controlled, double-blind, randomized clinical trial of Lactobacillus rhamnosus GG in healthy middle-aged and older adults. Fasting blood glucose and HbA1c were quantified at baseline and follow up.
RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
CONCLUSIONS


If replicated, Lactobacillus rhamnosus GG may protect against changes in glycemic control.",2020,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","['middle age and older adults without type 2 diabetes mellitus', 'healthy middle-aged and older adults', 'persons with diabetes']","['placebo', 'Lactobacillus rhamnosus GG', 'Lactobacillus rhamnosus GG and HbA1c', 'Probiotic supplementation']","['glycemic control', 'HbA1c values', 'Fasting blood glucose and HbA1c']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.163147,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Sanborn', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA. Electronic address: vsanborn@kent.edu.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, and UNC Microbiome Core, Center for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA; Brain Health Research Institute, Kent State University, USA.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.034']
1476,32570059,"Effect of photobiomodulation on salivary flow and composition, xerostomia and quality of life of patients during head and neck radiotherapy in short term follow-up: A randomized controlled clinical trial.","Xerostomia and hyposalivation are frequent conditions in patients undergoing head and neck radiotherapy, which usually lead to a worsening of quality of life. This study aimed to assess whether photobiomodulation (PBM) can minimize hyposalivation, xerostomia and qualitative changes on saliva and improve quality of life in patients undergoing radiotherapy in short-term follow-up. Twenty-one patients were randomly divided into two groups: sham group (SG) and laser group (LG). A diode laser was used for intra- (660 nm, 10 J/cm 2 , 0.28 J per point, 40 mW) and extra-oral (810 nm, 25 J/cm 2 , 0.7 J per point, 40 mW) applications over the salivary glands, three times a week, during the entire radiotherapy period. In SG, the tip of the instrument was sealed with blue rubber to prevent the passage of light. Xerostomia and pH were evaluated and unstimulated and stimulated salivary flow was determined before the start of radiotherapy (T1), after the 15th session (T2), after the end of radiotherapy (T3) and 60 days after radiotherapy (T4). Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities were evaluated in stimulated saliva samples. Quality of life was assessed at times T1 and T4. Generalized estimating equations were used to assess differences in the outcome between times and groups. All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001). An increase in chloride concentrations was observed at times T3 and T4 (p < 0,05), and a reduction in amylase activity at T3 (p < .05). Unstimulated saliva pH was higher in LG than SG at T3 (p = .037). No difference between groups was noted in relation to salivary flow and composition, xerostomia or quality of life. Our results suggest that PBM may help in preserving salivary pH during radiotherapy.",2020,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","['patients undergoing head and neck', 'patients during head and neck radiotherapy in short term follow-up', 'patients undergoing radiotherapy in short-term follow-up', 'Twenty-one patients']","['radiotherapy', 'photobiomodulation (PBM', 'photobiomodulation', 'sham group (SG) and laser group (LG', 'diode laser', 'PBM']","['quality of life', 'Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities', 'Unstimulated saliva pH', 'relation to salivary flow and composition, xerostomia or quality of life', 'amylase activity', 'Quality of life', 'salivary flow and composition, xerostomia and quality of life', 'chloride concentrations', 'Xerostomia and pH', 'salivary flow, xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",21.0,0.0663906,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","[{'ForeName': 'Gabriel Campos', 'Initials': 'GC', 'LastName': 'Louzeiro', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cherubini', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Maria Antonia Zancanaro', 'Initials': 'MAZ', 'LastName': 'de Figueiredo', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda Gonçalves', 'Initials': 'FG', 'LastName': 'Salum', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: fernanda.salum@pucrs.br.'}]","Journal of photochemistry and photobiology. B, Biology",['10.1016/j.jphotobiol.2020.111933']
1477,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND


Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS


We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS


A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS


There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1478,32571773,"Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018.","BACKGROUND


Patients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir.
AIM


To determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2).
DESIGN AND SETTING


Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries.
METHOD


Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache.
RESULTS


Coronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3-6) versus 5 days (IQR 3-8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66;  P  = 0.026).
CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.",2020,"CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","['Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2', 'Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2', 'coronavirus illness', 'Patients infected with the novel coronavirus (SARS-CoV-2', 'European primary care from 2016 to 2018', 'Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries', 'symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2']","['usual care plus oseltamivir', 'oseltamivir', 'Oseltamivir', 'usual care or usual care plus oseltamivir']","['time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache', 'median time to recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3266.0,0.207108,"CONCLUSION


Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Family Medicine & Health Policy (FAMPOP); Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cianci', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas, US; adjunct assistant professor, Vanderbilt University, Department of Biostatistics, Nashville, Tennessee, US.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Muireann', 'Initials': 'M', 'LastName': 'de Paor', 'Affiliation': 'Department of General Practice, Royal College of Surgeons in Ireland School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711941']
1479,32544269,Evaluation of preventive laser photobiomodulation in patients with head and neck cancer undergoing radiochemotherapy: Laser in patients with head and neck cancer.,"AIMS


This study aimed to evaluate the effect of laser photobiomodulation in the prevention of oral mucositis (OM), salivary hypofunction and referred pain in patients with head and neck cancer.
METHODS AND RESULTS


This randomized clinical study divided patients into two groups: the laser group (LG, n = 30) and the control group (CG, n = 24). The LG (InGaAlP, 660 nm, 86.7 mW, 2 J/cm 2  ) participated in the preventive protocol, while the CG underwent a simulated procedure without light emission. The degree of OM, salivary flow, and referred pain were evaluated at five different periods of radiotherapy. Both groups showed a significant increase in the degree of OM (P < .01). Regarding OM, salivary flow, and oral pain, there were no significant differences between the groups.
CONCLUSIONS


The laser photobiomodulation protocol used in this study was not effective in preventing radiochemotherapy-induced OM, salivary hypofunction, and referred pain in patients with head and neck cancer. Notably, although the development of OM did not differ significantly according to the use of laser therapy, the severity of oral mucositis was reduced in patients who underwent laser therapy compared to that in patients who did not.",2020,Both groups showed a significant increase in the degree of OM (P < .01).,"['patients with head and neck cancer', 'patients with head and neck cancer undergoing']","['laser therapy', 'radiochemotherapy', 'preventive laser photobiomodulation', 'laser photobiomodulation']","['oral mucositis (OM), salivary hypofunction and referred pain', 'severity of oral mucositis', 'degree of OM', 'OM, salivary flow, and oral pain', 'degree of OM, salivary flow, and referred pain', 'OM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0234250', 'cui_str': 'Referred pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}]",,0.020856,Both groups showed a significant increase in the degree of OM (P < .01).,"[{'ForeName': 'Juliana Borges de Lima', 'Initials': 'JBL', 'LastName': 'Dantas', 'Affiliation': 'Masters in Dentistry at Bahiana School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Gabriela Botelho', 'Initials': 'GB', 'LastName': 'Martins', 'Affiliation': 'Associate Professor of Health Sciences Institute of the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Hayana Ramos', 'Initials': 'HR', 'LastName': 'Lima', 'Affiliation': 'Adjunct Professor, Center of Health Sciences, Federal University of Southern Bahia, Teixeira de Freitas, Bahia, Brazil.'}, {'ForeName': 'Manoela', 'Initials': 'M', 'LastName': 'Carrera', 'Affiliation': 'Adjunct Professor of Stomatology at the Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Sílvia Regina de Almeida', 'Initials': 'SRA', 'LastName': 'Reis', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Alena Ribeiro Alves Peixoto', 'Initials': 'ARAP', 'LastName': 'Medrado', 'Affiliation': 'Adjunct Professor at Bahiana - School of Medicine and Public Health, Salvador, Bahia, Brazil.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12486']
1480,32545534,"Self-Regulation in Children with Neurodevelopmental Disorders ""SR-MRehab: Un Colegio Emocionante"": A Protocol Study.","Self-regulation refers to the ability to control and modulate behavior, and it can include both emotional and cognitive modulation. Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years of age with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of ""SR-MRehab: Un colegio emocionante"", based on a non-immersive virtual reality system where virtual objects can be managed by children in a natural way using their hands. Children will be recruited from several schools of Granada (Spain) and they will be randomly allocated to two groups. An assessment will be conducted before and after the intervention and 24 weeks after the end of the intervention process. The experimental group will receive the intervention using virtual reality. The control group will receive a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated. The results will be published and will provide evidence regarding the use of this type of intervention in children with neurodevelopmental disorders. Trial registration: Registered with code NCT04418921.",2020,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","['children with neurodevelopmental disorders', 'Children with neurodevelopmental disorders', 'children between 6 and 11 years of age with neurodevelopmental disorders', 'Children with Neurodevelopmental Disorders', 'Children will be recruited from several schools of Granada (Spain']","['standard self-regulation program', 'SR-MRehab', 'Methodology']",['self-regulation skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0449342,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","[{'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Romero-Ayuso', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alcántara-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Almenara-García', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nuñez-Camarero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José Matías', 'Initials': 'JM', 'LastName': 'Triviño-Juárez', 'Affiliation': 'Primary Care Center Zaidín Sur, Granada Metropolitan Sanitary District, 18007 Granada, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Ariza-Vega', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José-Pascual', 'Initials': 'JP', 'LastName': 'Molina', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124198']
1481,32545539,"Identifying Social Network Conditions that Facilitate Sedentary Behavior Change: The Benefit of Being a ""Bridge"" in a Group-based Intervention.","Using data from one of the first trials to try to leverage social networks as a mechanism for obesity intervention, we examined which social network conditions amplified behavior change. Data were collected as part of a community-based healthy lifestyle intervention in Nashville, USA, between June 2014 and July 2017. Adults randomized to the intervention arm were assigned to a small group of 10 participants that met in person for 12 weekly sessions. Intervention small group social networks were measured three times; sedentary behavior was measured by accelerometry at baseline and 12 months. Multivariate hidden Markov models classified people into distinct social network trajectories over time, based on the structure of the emergent network and where the individual was embedded. A multilevel regression analysis assessed the relationship between network trajectory and sedentary behavior (N = 261). Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04]. Certain social network conditions may make it easier to reduce adult sedentary behavior in group-based interventions. While further research will be necessary to establish causality, the implications for intervention design are discussed.",2020,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].",[],[],[],[],[],[],,0.0215047,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].","[{'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'de la Haye', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA 90007, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Santiago J', 'Initials': 'SJ', 'LastName': 'Saldana', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124197']
1482,32549208,Evaluation of Sleep Quality in a Disaster Evacuee Environment.,"We aimed to evaluate sleep and sleep-related physiological parameters (heart rate variability and glucose dynamics) among evacuees by experimentally recreating the sleep environment of evacuation shelters and cars. Nine healthy young male subjects participated in this study. Two interventions, modeling the sleep environments of evacuation shelters (evacuation shelter trial) and car seats (car trial), were compared with sleep at home (control trial). Physiological data were measured using portable two-channel electroencephalogram and electrooculogram monitoring systems, wearable heart rate sensors, and flash glucose monitors. Wake after sleep onset (WASO) and stage shift were greater in both intervention trials than the control trial, while rapid-eye movement (REM) latency and non-rapid eye movement (NREM) 1 were longer and REM duration was shorter in the evacuation shelter trial than the control trial. Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial. It was confirmed that sleep environment was important to maintain sleep, and affected glucose dynamics and heart rate variability in the experimental situation.",2020,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"['Nine healthy young male subjects', 'evacuees by experimentally recreating the sleep environment of evacuation shelters and cars']",[],"['glucose dynamics and heart rate variability', 'Glucose dynamics and power at low frequency (LF.p) of heart rate variability', 'REM duration', 'rapid-eye movement (REM) latency and non-rapid eye movement (NREM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C3178959', 'cui_str': 'Evacuation Shelter'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}]",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",9.0,0.0882766,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kayaba', 'Affiliation': 'Department of Somnology, Tokyo Medical University, Tokyo 160-0023, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Kaneko', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kiyono', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17124252']
1483,32557560,Spatial regression and spillover effects in cluster randomized trials with count outcomes.,"This paper describes methodology for analyzing data from cluster randomized trials with count outcomes, taking indirect effects as well spatial effects into account. Indirect effects are modeled using a novel application of a measure of depth within the intervention arm. Both direct and indirect effects can be estimated accurately even when the proposed model is misspecified. We use spatial regression models with Gaussian random effects, where the individual outcomes have distributions overdispersed with respect to the Poisson, and the corresponding direct and indirect effects have a marginal interpretation. To avoid spatial confounding, we use orthogonal regression, in which random effects represent spatial dependence using a homoscedastic and dimensionally reduced modification of the intrinsic conditional autoregression model. We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.",2020,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.",[],[],[],[],[],[],,0.0463177,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'Department of Mathematical Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Biometrics,['10.1111/biom.13316']
1484,32558989,"Effects of danicamtiv, a novel cardiac myosin activator, in heart failure with reduced ejection fraction: experimental data and clinical results from a phase 2a trial.","AIMS


Both left ventricular (LV) and left atrial (LA) dysfunction and remodelling contribute to adverse outcomes in heart failure with reduced ejection fraction (HFrEF). Danicamtiv is a novel, cardiac myosin activator that enhances cardiomyocyte contraction.
METHODS AND RESULTS


We studied the effects of danicamtiv on LV and LA function in non-clinical studies (ex vivo: skinned muscle fibres and myofibrils; in vivo: dogs with heart failure) and in a randomized, double-blind, single- and multiple-dose phase 2a trial in patients with stable HFrEF (placebo, n = 10; danicamtiv, n = 30; 50-100 mg twice daily for 7 days). Danicamtiv increased ATPase activity and calcium sensitivity in LV and LA myofibrils/muscle fibres. In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL, P < 0.05) and LA emptying fraction (+10.7%, P < 0.05). In patients with HFrEF (mean age 60 years, 25% women, ischaemic heart disease 48%, mean LV ejection fraction 32%), treatment-emergent adverse events, mostly mild, were reported in 17 patients (57%) receiving danicamtiv and 4 patients (40%) receiving placebo. Danicamtiv (at plasma concentrations ≥2000 ng/mL) increased stroke volume (up to +7.8 mL, P < 0.01), improved global longitudinal (up to -1.0%, P < 0.05) and circumferential strain (up to -3.3%, P < 0.01), decreased LA minimal volume index (up to -2.4 mL/m 2  , P < 0.01) and increased LA function index (up to 6.1, P < 0.01), when compared with placebo.
CONCLUSIONS


Danicamtiv was well tolerated and improved LV systolic function in patients with HFrEF. A marked improvement in LA volume and function was also observed in patients with HFrEF, consistent with pre-clinical findings of direct activation of LA contractility.",2020,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","['heart failure with reduced ejection fraction', 'heart failure with reduced ejection fraction (HFrEF', 'vivo: dogs with heart failure', 'patients with stable', 'patients with HFrEF']","['danicamtiv, a novel cardiac myosin activator', 'HFrEF (placebo', 'placebo']","['circumferential strain', 'LA function index', 'LA volume and function', 'stroke volume', 'tolerated and improved LV systolic function', 'LV and LA function', 'LA minimal volume index', 'LA emptying fraction', 'LV stroke volume', 'global longitudinal', 'ATPase activity and calcium sensitivity']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0949656', 'cui_str': 'Cardiac Myosin'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001473', 'cui_str': 'Adenosinetriphosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.144767,"In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL; p<0.05) and LA emptying fraction (+10.7%, p<0.05).","[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tamby', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, FL, USA.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Forgosh', 'Affiliation': 'HealthEast Heart Care, Saint Paul, MN, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Tennova Healthcare-Harton, Tullahoma, TN, USA.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Karra', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henk P', 'Initials': 'HP', 'LastName': 'Swart', 'Affiliation': 'Antonius Ziekenhuis Sneek, Sneek, The Netherlands.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wagner', 'Affiliation': 'Charité Research Organization, Berlin, Germany.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Hershberger', 'Affiliation': 'Divisions of Human Genetics and Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Cardiovascular Imaging Core Laboratory, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Anto', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kaylyn', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Henze', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kurio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Sam L', 'Initials': 'SL', 'LastName': 'Teichman', 'Affiliation': 'Teichman Drug Development Consulting, Oakland, CA, USA.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Del Rio', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1933']
1485,32553118,"Berzosertib plus gemcitabine versus gemcitabine alone in platinum-resistant high-grade serous ovarian cancer: a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND


High-grade serous ovarian cancers show increased replication stress, rendering cells vulnerable to ATR inhibition because of near universal loss of the G1/S checkpoint (through deleterious TP53 mutations), premature S phase entry (due to CCNE1 amplification, RB1 loss, or CDKN2A mRNA downregulation), alterations of homologous recombination repair genes, and expression of oncogenic drivers (through MYC amplification and other mechanisms). We hypothesised that the combination of the selective ATR inhibitor, berzosertib, and gemcitabine could show acceptable toxicity and superior efficacy to gemcitabine alone in high-grade serous ovarian cancer.
METHODS


In this multicentre, open-label, randomised, phase 2 study, 11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting. Eligible patients were randomly assigned (1:1) to receive intravenous gemcitabine (1000 mg/m 2 ) on day 1 and day 8, or gemcitabine plus intravenous berzosertib (210 mg/m 2 ) on day 2 and day 9 of a 21-day cycle until disease progression or intolerable toxicity. Randomisation was done centrally using the Theradex Interactive Web Response System, stratified by platinum-free interval, and with a permuted block size of six. Following central randomisation, patients and investigators were not masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival, and analyses included all patients who received at least one dose of the study drugs. The study is registered with ClinicalTrials.gov, NCT02595892, and is active but closed to enrolment.
FINDINGS


Between Feb 14, 2017, and Sept 7, 2018, 88 patients were assessed for eligibility, of whom 70 were randomly assigned to treatment with gemcitabine alone (36 patients) or gemcitabine plus berzosertib (34 patients). At the data cutoff date (Feb 21, 2020), the median follow-up was 53·2 weeks (25·6-81·8) in the gemcitabine plus berzosertib group and 43·0 weeks (IQR 23·2-69·1) in the gemcitabine alone group. Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044). The most common treatment-related grade 3 or 4 adverse events were decreased neutrophil count (14 [39%] of 36 patients in the gemcitabine alone group vs 16 [47%] of 34 patients in the gemcitabine plus berzosertib group) and decreased platelet count (two [6%] vs eight [24%]). Serious adverse events were observed in ten (28%) patients in the gemcitabine alone group and nine (26%) patients in the gemcitabine plus berzosertib group. There was one treatment-related death in the gemcitabine alone group due to sepsis and one treatment-related death in the gemcitabine plus berzosertib group due to pneumonitis.
INTERPRETATION


To our knowledge, this is the first randomised study of an ATR inhibitor in any tumour type. This study shows a benefit of adding berzosertib to gemcitabine in platinum-resistant high-grade serous ovarian cancer. This combination warrants further investigation in this setting.
FUNDING


US National Cancer Institute.",2020,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","['platinum-resistant high-grade serous ovarian cancer', '88 patients were assessed for eligibility, of whom 70', '11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting', 'Eligible patients', 'Between Feb 14, 2017, and Sept 7, 2018']","['Berzosertib plus gemcitabine', 'gemcitabine plus intravenous berzosertib', 'gemcitabine alone', 'intravenous gemcitabine', 'gemcitabine plus berzosertib', 'gemcitabine', 'berzosertib to gemcitabine']","['platelet count', 'Median progression-free survival', 'neutrophil count', 'death', 'investigator-assessed progression-free survival', 'Serious adverse events']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",88.0,0.0861426,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","[{'ForeName': 'Panagiotis A', 'Initials': 'PA', 'LastName': 'Konstantinopoulos', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: panagiotis_konstantinopoulos@dfci.harvard.edu.'}, {'ForeName': 'Su-Chun', 'Initials': 'SC', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Wahner Hendrickson', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Schumer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'L Austin', 'Initials': 'LA', 'LastName': 'Doyle', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Center, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Marta A', 'Initials': 'MA', 'LastName': 'Crispens', 'Affiliation': 'Department of Obstetrics and Gynecology, Ingram Cancer Center, Vanderbilt University Nashville, TN, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Olawaiye', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ira S', 'Initials': 'IS', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Barroilhet', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin Hospital and Clinics, Madison, WI, USA.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McHale', 'Affiliation': 'Department of Obstetrics and Gynecology, Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Färkkilä', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dipanjan', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Roxanne S', 'Initials': 'RS', 'LastName': 'Quinn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bowes', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': ""D'Andrea"", 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30180-7']
1486,32554105,Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.,"BACKGROUND


We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual.
METHODS


We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values.
RESULTS


We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane.
CONCLUSIONS


Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.",2020,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","['328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline', 'primary care patients', 'managing major depression and chronic musculoskeletal pain in primary care']",['collaborative care program'],"['Cost-effectiveness', 'mean incremental effectiveness', 'mean incremental cost', 'health status', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",328.0,0.0923458,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","[{'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Aragonès', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sánchez-Iriso', 'Affiliation': 'Department of Economics, Public University of Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'López-Cortacans', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Tomé-Pires', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; ISCTE-Lisbon University Institute (ISCTE-IUL), Center for Social Research and Intervention (CIS-IUL), Lisbon, Portugal.""}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Rambla', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': ""Unit for the Study and Treatment of Pain - ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110167']
1487,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1488,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE


The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid.
METHODS


Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded.
RESULTS


The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant.
CONCLUSION


The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time.
TRIAL REGISTRATION NUMBER


NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140']
1489,32554566,Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial.,"OBJECTIVE


To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy.
DESIGN


Pragmatic, multicentre, cluster randomised controlled trial.
SETTING


359 general practices in Austria, Germany, Italy, and the United Kingdom.
PARTICIPANTS


3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner.
INTERVENTION


A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual.
MAIN OUTCOME MEASURES


The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs.
RESULTS


3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953  v  1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682  v  873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
CONCLUSIONS


In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN10137559.",2020,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
","['elderly people with polypharmacy', '3904 adults were enrolled between January and October 2015', '181 practices and 1953 participants', 'elderly people with chronic diseases', '359 general practices in Austria, Germany, Italy, and the United Kingdom', '3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner']","['electronic decision support tool', 'electronic decision support tool or to provide treatment as usual', 'computerised decision support tool', 'electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group']","['number of drugs', 'unplanned hospital admission or death by 24 months', 'composite of unplanned hospital admission or death by 24 months', 'number of prescribed drugs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",3904.0,0.221708,"By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42  v  0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001).
","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany Anja.Rieckert@uni-wh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Drewelow', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Aneez', 'Initials': 'A', 'LastName': 'Esmail', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Centre for Biostatistics, School for Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Klaassen-Mielke', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Germany.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kunnamo', 'Affiliation': 'Duodecim Medical Publications, Helsinki, Finland.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Löffler', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Piccoliori', 'Affiliation': 'Institute for General Practice of Bolzano, Bolzano, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sommerauer', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Ulrike S', 'Initials': 'US', 'LastName': 'Trampisch', 'Affiliation': 'Institute of General Practice and Family Medicine, Witten/Herdecke University, Alfred-Herrhausen-Strasse 50, 58448 Witten, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vögele', 'Affiliation': 'Institute for Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Adrine', 'Initials': 'A', 'LastName': 'Woodham', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'National Institute for Health Research School for Primary Care Research, School of Health Sciences, University of Manchester, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1822']
1490,32554766,Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing.,"OBJECTIVE


To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.
METHODS


We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.
RESULTS


The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent""). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.
CONCLUSIONS


Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.",2020,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","['18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label', '16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date', 'critically ill patients with TBI', 'patients who are critically ill with traumatic brain injury (ciTBI']","['36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing']",['acceptability'],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",12.0,0.089653,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Muehlschlegel', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA. susanne.muehlschlegel@umassmemorial.org.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Flahive', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Goostrey', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jolanta J', 'Initials': 'JJ', 'LastName': 'Pach', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Knies', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}]",Neurology,['10.1212/WNL.0000000000009770']
1491,32554770,Comorbidity is associated with disease activity in MS: Findings from the CombiRx trial.,"OBJECTIVE


To determine whether comorbidity is associated with clinical (relapses, disability worsening) and MRI outcomes in multiple sclerosis (MS), we conducted a secondary analysis of the CombiRx clinical trial.
METHODS


CombiRx compared interferon-beta-1a, glatiramer acetate and the combination of these agents. For participants eligible for evaluation of 6-month confirmed disability worsening, we used medical history, concomitant medications and adverse events to ascertain comorbidity status. Comorbidities evaluated included hypertension, dyslipidemia, diabetes, depression, anxiety disorders, and migraine. Clinical outcomes included disease activity consisting of protocol-defined relapses, disability worsening and MRI activity. We summarized the prevalence of these comorbidities and their association with disease activity and its components using multivariable Cox regression.
RESULTS


Of the 1008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup the median length of follow-up was 3.4 years (range 0.5-6.9 years). Overall, 55.1% of participants had ≥1 comorbidity at enrollment. After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80; 95%CI: 0.67-0.96) was associated with a decreased hazard.
CONCLUSIONS


In this large trial population with rigorously obtained outcomes, comorbidities were common among participants and influenced disease outcomes, including relapses. The comorbidity burden of clinical trial participants with MS may be an important factor in the outcome of clinical trials. Additional investigations of the impact of comorbidity on clinical trial outcomes, and response to disease-modifying therapies is warranted.",2020,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","['1008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup the median length of follow-up was 3.4 years (range 0.5-6.9 years', 'multiple sclerosis (MS']","['interferon-beta-1a, glatiramer acetate']","['disease activity consisting of protocol-defined relapses, disability worsening and MRI activity', 'hypertension, dyslipidemia, diabetes, depression, anxiety disorders, and migraine', 'dyslipidemia', 'hazard of any disease activity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]",1008.0,0.179747,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Department of Biostatistics, Washington University in St. Louis, St. Louis, MO, USA amber@wustl.edu.'}, {'ForeName': 'Kaarina', 'Initials': 'K', 'LastName': 'Kowalec', 'Affiliation': 'College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, CAN.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama in Birmingham School of Public Health, Birmingham, AL, USA.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Marrie', 'Affiliation': 'Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, CAN.'}]",Neurology,['10.1212/WNL.0000000000010024']
1492,32574801,Emotion generation and regulation following an intrusion induction: Implications for taboo or autogenous obsessions.,"BACKGROUND AND OBJECTIVES


Research demonstrates that autogenous (AO) and reactive obsessions (RO) differ in obsessional content; however, no experimental research has examined differences in emotion generation and regulation. Characterizing this taxonomy with respect to emotion generation and regulation could refine conceptualizations of obsessionality and optimize clinical interventions.
METHODS


Seventy undergraduates were randomly assigned to imagine a personally-relevant AO or RO. Subsequently, emotional reactivity was assessed. Participants then rated their emotion regulation efforts and the degree to which the intrusion violated their values.
RESULTS


Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion. A conditional process analysis revealed that the relationship between the AO condition and emotion regulation difficulties was explained by an increase in negative emotional reactivity, and the strength of this effect depended upon the degree of conflict with participants' values.
LIMITATIONS


The use of an analogue sample, and minimal emotional reactivity in the RO condition, threaten the ecological and external validity of the study.
CONCLUSIONS


The current study employed a novel experimental design demonstrating a meaningful relationship between AOs and both emotional activation and regulation. Results highlight the relevance of self-conscious emotions to the conceptualization of AOs and the utility of addressing them in the context of exposure therapy.",2020,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","['taboo or autogenous obsessions', 'Seventy undergraduates']",['imagine a personally-relevant AO or RO'],"['negative emotional reactivity', 'self-conscious emotions (guilt, shame, and embarrassment', 'AO condition and emotion regulation difficulties', 'emotional reactivity']","[{'cui': 'C0039227', 'cui_str': 'Taboo'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",70.0,0.0314195,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","[{'ForeName': 'Noah Chase', 'Initials': 'NC', 'LastName': 'Berman', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA. Electronic address: nberman@holycross.edu.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Szkutak', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101593']
1493,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1494,32575919,Gamification in Physical Education: Evaluation of Impact on Motivation and Academic Performance within Higher Education.,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages. Therefore, this research aimed to analyse its impact on the motivations and academic performances of university students. The research was carried out in the training of future teachers specialising in physical education during two academic courses. In total, 127 students participated in the study, divided into a gamified experimental group ( n  = 62) and a control group ( n  = 65). The participants completed a questionnaire to assess motivation in physical education before and after the intervention and performed a final exam to assess academic performance. The results indicated an increase in external regulation in the experimental group only. Furthermore, this group achieved significantly better academic performance. The findings of this study suggest that gamified implementation is beneficial for academic performance at the university stage, even though intrinsic motivation does not change. Furthermore, the nature of rewards or punishments, as characteristic of this pedagogical approach, could play an important role in the expected results, since external regulation increased significantly after the intervention.",2020,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","['127 students participated in the study, divided into a gamified experimental group ( n  = 62) and a control group ( n  = 65', 'university students']",[],"['academic performance', 'Motivation and Academic Performance', 'external regulation']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",127.0,0.0193045,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ferriz-Valero', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Østerlie', 'Affiliation': 'Research Group DiTePES: Digital Technology in Physical Education and Sports, NTNU-Norwegian University of Science and Technology, NO-7491 Trondheim, Norway.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'García Martínez', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'García-Jaén', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124465']
1495,32552264,Extended-Release Oral Milrinone for the Treatment of Heart Failure With Preserved Ejection Fraction.,"Background Heart failure with preserved ejection fraction (HFpEF) is an increasingly prevalent form of heart failure, representing half of the total burden of heart failure. We hypothesised that modulation of the phosphodiesterase type 3/cyclic AMP using a novel oral formulation of milrinone might exert favorable effects HFpEF via pulmonary and systemic vasodilation and enhancement of ventricular relaxation. We assessed the safety and efficacy of oral milrinone on quality of life and functional outcomes in patients with HFpEF. Methods and Results The MilHFPEF (Extended Release Oral Milrinone for the Treatment of Heart Failure With Preserved Ejection Fraction) study was a randomized, double-blind, placebo-controlled pilot study in 23 patients with symptomatic HFpEF. Efficacy end points included changes from baseline in Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walk distance. The primary safety end point was the development of clinically significant arrhythmia. The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046). Six-minute walk distance also tended to improve in the treatment group compared with placebo (+22 [-8 to 49] versus -47 [-97 to 12];  P =0.092). Heart rate (-1±5 versus -2±9 bpm;  P =0.9) and systolic blood pressure (-3±18 versus +1±12 mm Hg;  P =0.57) were unchanged. Early filling velocity/early mitral annular velocity (-0.3±3.0 versus -1.9±4.8;  P =0.38) was unchanged. One patient in the placebo arm was hospitalized for heart failure. Holter monitoring did not demonstrate evidence of a proarrhythmic effect of milrinone. Conclusions In this novel pilot study, extended release oral milrinone was well tolerated and associated with improved quality of life in patients with HFpEF. Further longer-term studies are warranted to establish the role of this therapeutic approach in HFpEF. Registration URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12616000619448.",2020,The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046).,"['Heart Failure With Preserved Ejection Fraction', '23 patients with symptomatic HFpEF', 'patients with HFpEF', 'Heart Failure']","['Milrinone', 'preserved ejection fraction (HFpEF', 'milrinone', 'MilHFPEF', 'placebo']","['Early filling velocity/early mitral annular velocity', 'quality of life', 'Kansas City Cardiomyopathy Questionnaire score', 'Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walk distance', 'heart failure', 'Heart rate', 'systolic blood pressure ', 'safety and efficacy', 'development of clinically significant arrhythmia', 'quality of life and functional outcomes']","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",23.0,0.228525,The Kansas City Cardiomyopathy Questionnaire score improved significantly in milrinone-treated patients compared with placebo (+10±13 versus -3±15;  P =0.046).,"[{'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Nanayakkara', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Heart Failure Research Group Baker Heart and Diabetes Institute Melbourne Australia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Mak', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Department of Cardiology Alfred Hospital Melbourne Australia.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015026']
1496,32553471,Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial.,"OBJECTIVE


To determine the impact of oil-based versus water-based contrast on pregnancy and live birth rates ≤5 years after hysterosalpingography (HSG) in infertile women.
DESIGN


A 5-year follow-up study of a multicenter randomized trial.
SETTING


Hospitals.
PATIENT(S)


Infertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology.
INTERVENTION(S)


Use of oil-based versus water-based contrast during HSG.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy, live births, time to ongoing pregnancy, second ongoing pregnancy.
RESULT(S)


A total of 1,119 women were randomly assigned to HSG with oil-based contrast (n = 557) or water-based contrast (n = 562). After 5 years, 444 of 555 women in the oil group (80.0%) and 419 of 559 women in the water group (75.0%) had an ongoing pregnancy (relative risk [RR] 1.07; 95% confidence interval [CI] 1.00-1.14), and 415 of 555 women in the oil group (74.8%) and 376 of 559 women in the water group (67.3%) had live births (RR 1.11; 95% CI 1.03-1.20). In the oil group, 228 pregnancies (41.1%) were conceived naturally versus 194 (34.7%) pregnancies in the water group (RR 1.18; 95% CI 1.02-1.38). The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43). No difference was found in the occurrence of a second ongoing pregnancy.
CONCLUSION(S)


During a 5-year time frame, ongoing pregnancy and live birth rates are higher after tubal flushing with oil-based contrast during HSG compared with water-based contrast. More pregnancies are naturally conceived and time to ongoing pregnancy is shorter after HSG with oil-based contrast.
CLINICAL TRIAL REGISTRATION NUMBER


Netherlands Trial Register (NTR) 3270 and NTR6577(www.trialregister.nl).",2020,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","['infertile women', 'A total of 1,119 women', '\n\n\nInfertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology', 'Hospitals']","['hysterosalpingography (HSG', 'Tubal flushing with oil-based or water-based contrast at hysterosalpingography', 'oil-based versus water-based contrast during HSG', 'oil-based versus water-based contrast', 'HSG with oil-based contrast (n = 557) or water-based contrast']","['time to ongoing pregnancy', 'ongoing pregnancy', 'occurrence of a second ongoing pregnancy', 'live births', '5-year time frame, ongoing pregnancy and live birth rates']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}]",1119.0,0.17144,"The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43).","[{'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: j.vanrijswijk@amsterdamumc.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Clarabelle T', 'Initials': 'CT', 'LastName': 'Pham', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Victoria, Australia.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam; the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'Department of Reproductive Medicine and Gynaecology, University of Groningen, University Medical Centre Groningen, Hanzeplein, the Netherlands.'}, {'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Hertogenbosch, the Netherlands.'}, {'ForeName': 'Annemiek W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Machiel H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo, the Netherlands.'}, {'ForeName': 'Angelique J C M', 'Initials': 'AJCM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Gelderse Vallei, Ede, the Netherlands.'}, {'ForeName': 'Ilse A J', 'Initials': 'IAJ', 'LastName': 'van Rooij', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Henrike G M', 'Initials': 'HGM', 'LastName': 'van Rijnsaardt-Lukassen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Ron J T', 'Initials': 'RJT', 'LastName': 'van Golde', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Cathelijne F', 'Initials': 'CF', 'LastName': 'van Heteren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Pelinck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Annette E J', 'Initials': 'AEJ', 'LastName': 'Duijn', 'Affiliation': 'Vrouwenkliniek Zuidoost, Amsterdam, the Netherlands.'}, {'ForeName': 'Mesrure', 'Initials': 'M', 'LastName': 'Kaplan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.03.022']
1497,32556602,Effect of food on the pharmacokinetics of the WEE1 inhibitor adavosertib (AZD1775) in patients with advanced solid tumors.,"PURPOSE


To support future dosing recommendations, the effect of food on the pharmacokinetics of adavosertib, a first-in-class, small-molecule reversible inhibitor of WEE1 kinase, was assessed in patients with advanced solid tumors.
METHODS


In this Phase I, open-label, randomized, two-period, two-sequence crossover study, the pharmacokinetics of a single 300 mg adavosertib dose were investigated in fed versus fasted states.
RESULTS


Compared with the fasted state, a high-fat, high-calorie meal (fed state) decreased adavosertib maximum plasma concentration (C max ) by 16% and systemic exposure (area under the plasma concentration-time curve [AUC]) by 6%; AUC 0-t  decreased by 7% and time to maximum plasma concentration was delayed by 1.97 h (P = 0.0009). The 90% confidence interval of the geometric least-squares mean treatment ratio for AUC and AUC 0-t  was contained within the no-effect limits (0.8-1.25), while that of C max  crossed the lower bound of the no-effect limits. Adverse events (AEs) related to adavosertib treatment were reported by 20 (64.5%) of the 31 patients treated in this study. Grade ≥ 3 AEs were reported by four (12.9%) patients (one in the fed state, three in the fasted state); two of these AEs were considered treatment-related by the investigator. Three serious AEs were reported in three (9.7%) patients; these were not considered treatment-related. No patients discontinued because of treatment-related AEs, and no new safety signals were reported.
CONCLUSION


A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.",2020,"A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.",['patients with advanced solid tumors'],['WEE1 inhibitor adavosertib (AZD1775'],"['adavosertib maximum plasma concentration (C max ', 'Adverse events (AEs) related to adavosertib treatment', 'maximum plasma concentration', 'Grade\u2009≥']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4053677', 'cui_str': 'AZD-1775'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0666379,"A high-fat meal did not have a clinically relevant effect on the systemic exposure of adavosertib, suggesting that adavosertib can be administered without regard to meals.","[{'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Någård', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, R&D Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mei-Lin', 'Initials': 'ML', 'LastName': 'Ah-See', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'So', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Vermunt', 'Affiliation': 'The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Thistlethwaite', 'Affiliation': 'The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Labots', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roxburgh', 'Affiliation': 'Beaston West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'ICO - Site René, Saint Herblain, France.'}, {'ForeName': 'Liselot', 'Initials': 'L', 'LastName': 'Valkenburg-van Iersel', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Ottesen', 'Affiliation': 'Late Stage Development, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Clinical Pharmacology Biologics and Bioanalysis, Clinical Pharmacology and Safety Science, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Mugundu', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, R&D Clinical Pharmacology and Safety Sciences, AstraZeneca, 35 Gatehouse Drive, Waltham, MA, 02451, USA. ganesh.mugundu@astrazeneca.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04101-4']
1498,32553922,Conditioning automatic inhibition task: Introducing a novel task to associate automatic inhibition with specific cues.,"There is growing interest in methods for conditioning automatic inhibition with specific stimuli and the potential clinical implications of these methods. For example, OCD patients were shown to benefit from a computerized training program which aimed to create an association between OCD-related cues and stopping behaviors. In the current study, we aimed to investigate the ability to condition inhibition to specific stimuli and whether such conditioning can be generalized between tasks to last over time. Participants completed 6 training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT), over a 48 -h period, in which one randomly chosen color patch was associated with inhibition. The classic Stroop task was administered before and after the CAIT training. Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping. These results demonstrate the effect of the CAIT onto one specific stimulus, and that the effect generalized between the training and testing tasks. This provides novel evidence that the CAIT can be used to facilitate faster recruitment of inhibitory resources for a specific trained stimulus, which might later help resolve cognitive conflicts that require inhibition and might also have important clinical implications.",2020,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.",[],"['Conditioning Automatic Inhibition Task', ""training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT""]",['smaller congruency and interference effects'],[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1.0,0.0185002,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.","[{'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Hochman', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, The Hebrew University of Jerusalem, Israel. Electronic address: shacharh@post.bgu.ac.il.'}, {'ForeName': 'Shahaf', 'Initials': 'S', 'LastName': 'Leshem', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Avishai', 'Initials': 'A', 'LastName': 'Henik', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2020.108809']
1499,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND


The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS


STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION


The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029']
1500,32554368,A Web-Based Intervention for Young Adults Whose Parents Have a Mental Illness or Substance Use Concern: Protocol for a Randomized Controlled Trial.,"BACKGROUND


One in 5 young people grow up in a family where one parent has experienced a mental health problem or substance use concern. Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue. There is a paucity of accessible, age-appropriate interventions that address their needs.
OBJECTIVE


A 6-week, web-based intervention, ""mental illness: supported, preventative, online, targeted"" (mi.spot), was developed based on previous research and the competence enhancement model. This paper describes the protocol for a randomized controlled trial and details how the usage, safety, acceptability, and feasibility of the intervention will be determined.
METHODS


Participants will be recruited through social media and clinician referral. A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern will participate in a 2-arm parallel randomized controlled trial. The assessment will consist of a baseline measurement and 2 follow-up periods, posttest and 6-week follow-up, using the Mental Health Continuum short form; the Depression, Anxiety, and Stress Scale; the Coping Orientation to Problems Experienced inventory; the General Help Seeking Questionnaire; the Social Connectedness Scale; the Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure. Impact will be examined at pre, post, and follow-up time periods using analyses of variance that will include a within-subjects factor (time) and a between-subjects factor (intervention/control). Facilitator interviews will ascertain intervention feasibility. Participant interviews will ascertain intervention acceptability. Interview data will be analyzed within a qualitative framework. Usage (data analytics) across site features and several indicators of clinical safety will also be reported.
RESULTS


The impact of mi.spot will be examined at pre, post, and follow-up time periods using analyses of variance on each of the measures outlined above. There will be a within-subjects factor (time) and a between-subjects factor (intervention/control). Data analysis will employ the intention-to-treat principle by including all participants in the analyses. Qualitative interview data will be analyzed using interpretative phenomenological analysis along with respondent validation. The Monash University Human Research Ethics Committee (reference number: 2019-18660-30434) approved the trial on April 17, 2019. As of October 2, 2019, 30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group. Result are expected to be submitted for publication in December 2020.
CONCLUSIONS


Study results will provide reliable evidence on a web-based intervention that has the potential to make a difference to the lives of many vulnerable young adults. Implementation guidelines are needed to embed the intervention in different service sectors.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12619000335190; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000335190.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15626.",2020,"Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue.","['A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern', '30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group', 'Young Adults', 'Participants will be recruited through social media and clinician referral']",[],['Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",30.0,0.142765,"Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue.","[{'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Maybery', 'Affiliation': 'School of Rural Health, Monash University, Warragul, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reupert', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bartholomew', 'Affiliation': 'Wellways, Melbourne, Australia.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Cuff', 'Affiliation': 'Bouverie Centre, Melbourne, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Duncan', 'Affiliation': 'School of Rural Health, Monash University, Warragul, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Foster', 'Affiliation': 'School of Nursing, Midwifery & Paramedicine, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Matar', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pettenuzzo', 'Affiliation': 'Faculty of Education, Monash University, Clayton, Australia.'}]",JMIR research protocols,['10.2196/15626']
1501,32554385,Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial.,"BACKGROUND


The evidence-based National Diabetes Prevention Program (NDPP) is now widely disseminated, yet strategies to increase its effectiveness are needed, especially for underserved populations. The yearlong program promotes lifestyle changes for weight loss and can be offered in-person, online, via distance learning, or a combination of modalities. Less is known about which delivery features are optimal and may help address disparities in outcomes for subgroups. We previously demonstrated the efficacy of a stand-alone text messaging intervention based on the NDPP (SMS4PreDM) in a randomized controlled trial in a safety net health care system. Upon broader dissemination, we then showed that SMS4PreDM demonstrated high retention and modest weight loss at a relatively low cost, suggesting the potential to improve in-person NDPP delivery.
OBJECTIVE


In this study, we aim to compare the effectiveness of in-person NDPP classes with and without supplementary SMS4PreDM on attendance and weight loss outcomes to determine whether text messaging can enhance in-person NDPP delivery for a safety net patient population.
METHODS


From 2015 to 2017, patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability. Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285). This analysis compares the first two groups to evaluate whether supplemental text messaging may improve in-person NDPP outcomes. Outcomes for SMS4PreDM-only participants were previously reported. NDPP classes followed standard delivery guidelines, including weekly-to-monthly classes over a year. SMS4PreDM delivery included messages promoting lifestyle change and modest weight loss, sent 6 days per week for 12 months. Differences in characteristics between intervention groups were assessed using chi-square and t tests. Differences in NDPP attendance and weight loss outcomes were analyzed with multivariable linear and logistic regressions.
RESULTS


The mean age was 50.4 years (SD 13.9). Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic. An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black. A total of 48.4% (n=236) of participants elected to receive supplemental text message support in addition to NDPP classes. Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone. Relatively more women and Hispanic individuals enrolled in the NDPP with supplemental text messages than in NDPP classes alone, 83.9% (n=198) vs 69.0% (n=174, P<.001) and 68.6% (n=162) vs 50.0% (n=126, P=.001), respectively. Attendance and weight loss outcomes were comparable between groups.
CONCLUSIONS


Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP. Further research is needed to identify optimal strategies to improve the effectiveness of the NDPP.",2020,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","['An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black', 'patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability', 'From 2015 to 2017', 'Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285', 'Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic', 'The mean age was 50.4 years (SD 13.9', 'Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone']","['SMS4PreDM', 'NDPP (SMS4PreDM', 'supplemental text messaging', 'Supplemental Text Message Support With the National Diabetes Prevention Program', 'stand-alone text messaging intervention', 'person NDPP classes with and without supplementary SMS4PreDM']","['weight loss', 'NDPP attendance and weight loss outcomes', 'Attendance and weight loss outcomes', 'attendance and weight loss']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",488.0,0.157848,"Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP.","[{'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gutiérrez-Raghunath', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Michael Josh', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Denver Health, Denver, CO, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Denver Health, Denver, CO, United States.'}]",JMIR mHealth and uHealth,['10.2196/15478']
1502,32554690,Revolutionising participants' health and wellbeing through neuro-reprogramming via the Slimpod ®  app: a randomised controlled trial.,"BACKGROUND


Obesity is a global pandemic that threatens the health of the population and the sustainability of publicly funded health care. This randomised controlled trial addresses the gap in the literature surrounding unconscious persuasion and its use in weight loss and weight management. The Slimpod ®  tool is unlike any of those currently available on the market. Using breakthrough research in 'nudge' thinking, it is designed to retrain an adult's habitual and emotional response to foodstuffs. This therapeutic model allows unconscious thought to be shaped into a manner more consistent with a healthy lifestyle. Candidates can then take control of their eating behaviours to induce a holistic state of wellbeing.
AIM


To assess the effectiveness of an audio unconscious-persuasion weight loss/weight management intervention (Slimpod ® ) compared with audio relaxation (control).
METHOD


Eighty-two overweight adults were randomised to intervention ( n  = 41) and control groups ( n  = 41). Weight was assessed at trial commencement, mid-trial (12 weeks), and trial end (24 weeks). Secondary outcomes were assessed using the Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS), and Quality of Life Index Generic Version III (QLI-G3) at the start and end of the trial.
RESULTS


Reports found a statistically significant difference in mean weight loss between intervention group (1.7 kg at 12 weeks and 4.3 kg at 24 weeks) versus control (0.6 kg and 1.2 kg respectively) at  P <0.001. ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks. No significant differences in ESES negative affect sub-scale score or ECS were observed.
CONCLUSION


Slimpod ®  was effective at reducing weight and increasing eating self-efficacy in overweight adults.",2020,ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks.,"['overweight adults', ""Revolutionising participants' health and wellbeing through neuro-reprogramming via the Slimpod ®  app"", 'Eighty-two overweight adults']","['audio unconscious-persuasion weight loss/weight management intervention (Slimpod ® ', 'audio relaxation (control']","['mean weight loss', 'ESES negative affect sub-scale score or ECS', 'Weight', 'self-efficacy', 'Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS), and Quality of Life Index Generic Version III (QLI-G3', 'weight and increasing eating self-efficacy']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",82.0,0.136277,ESES scores showed greater self-efficacy ( P  = 0.008) in intervention at 24 weeks.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kyle', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Independent Statistical Consultant.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Roycroft-Davis', 'Affiliation': 'Wellpods International.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711701']
1503,32559335,Phase II Study of Low-Dose Afatinib Maintenance Treatment Among Patients with EGFR-Mutated Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1601 (NJLCG1601).,"LESSONS LEARNED


Low-dose afatinib maintenance treatment among patients with EGFR-mutated NSCLC achieved long-time to treatment failure with fewer treatment-related AEs without detracting from the therapeutic efficacy. This modified regimen represents a practical usage that balances effectiveness and safety.
BACKGROUND


Although afatinib is an effective therapy for patients with EGFR-mutated non-small cell lung cancer (NSCLC), drug-related adverse events (AEs) have often necessitated dose reductions. In a post hoc analysis of the LUX-Lung 3 and 6 trials, there was no difference in median progression-free survival (PFS) between patients who had the dose of afatinib reduced and those who did not. We thus evaluated the efficacy and tolerability of low-dose afatinib maintenance treatment among patients with NSCLC harboring EGFR mutations who had not been previously treated.
METHODS


Eligible patients received afatinib 40 mg orally once daily. When prescribed grade ≥ 2 AEs, rash of grade ≥ 3, or unacceptable toxicity occurred, the afatinib dose was reduced from 40 to 30 mg and if needed from 30 to 20 mg. The primary endpoint was the 1-year PFS rate. Secondary endpoints were PFS, overall response rate (ORR), and toxicity.
RESULTS


Among 30 patients, 93% had adenocarcinoma, 53% had exon 19 deletion, 37% had L858R, and 10% had minor mutations. The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4). The incidence rate of grade ≥ 3 toxicities was 57%, including elevated aspartate aminotransferase/alanine aminotransferase level (13%), diarrhea (10%), and paronychia (10%).
CONCLUSION


Low-dose afatinib maintenance treatment reduced treatment-related AEs without detracting from the therapeutic efficacy.",2020,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","['Eligible patients received', 'patients with EGFR-mutated non-small cell lung cancer (NSCLC', 'patients with EGFR-mutated NSCLC', 'Patients with EGFR-Mutated Non-Small Cell Lung Cancer', 'patients with NSCLC harboring EGFR mutations who had not been previously treated']","['afatinib 40 mg orally once daily', 'Low-Dose Afatinib Maintenance Treatment']","['diarrhea', 'incidence rate of grade ≥\u20093 toxicities', 'paronychia', '1-year PFS rate', 'PFS, overall response rate (ORR), and toxicity', 'elevated aspartate aminotransferase/alanine aminotransferase level', 'efficacy and tolerability', 'median progression-free survival (PFS', 'unacceptable toxicity', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.240061,"The 1-year PFS rate was 50% (95% confidence interval [CI], 31.3-66.1) and the median PFS was 11.8 months (95% CI, 7.1-21.4).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University, Hirosaki, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Sumito', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Dapartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Jingu', 'Affiliation': 'Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0545']
1504,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE


To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate.
STUDY DESIGN


The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here.
RESULTS


Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified.
CONCLUSION


Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043']
1505,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND


During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture.
RESEARCH QUESTION


Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults?
METHODS


In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints.
RESULTS


Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
SIGNIFICANCE


Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040']
1506,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES


Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement.
METHODS


Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC).
RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
LIMITATIONS


In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results.
CONCLUSIONS


ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577']
1507,32559669,A novel digital health intervention to improve patient engagement to stimulants in adult ADHD in the primary care setting: Preliminary findings from an open label study.,"AIMS


We piloted the effectiveness and acceptability of a novel text messaging-based (SMS) digital health intervention aimed at addressing the previously documented poor rate of patient engagement in stimulant treatment in the primary care setting.
METHODS


117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the SMS intervention. Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period. Using documented prescription records, we determined whether patients had timely prescription refills.
RESULTS


Ninety-six percent (N = 112) of participants completed our a priori metric of patient engagement consisting of 37 days of the SMS program. Eighty-one percent of participants refilled their index prescriptions in a timely manner compared to only 36% of patients receiving treatment as usual (OR=7.54, 95% CI: 4.46, 12.77; p<0.001). We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
CONCLUSIONS


These data suggest that an ADHD-centric, digital health intervention using text messaging significantly improves patient engagement in stimulant treatment in adults with ADHD.",2020,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[""Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period"", 'adults with ADHD', 'adult ADHD in the primary care setting', '117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the']","['SMS intervention', 'digital health intervention', 'novel text messaging-based (SMS) digital health intervention']",['patient engagement'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]",117.0,0.0801889,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Driscoll', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113158']
1508,32560069,Effects of a Physical Education Intervention on Academic Performance: A Cluster Randomised Controlled Trial.,"BACKGROUND


We investigated the effects of three different interventions on academic performance in students enrolled in the first year of high school.
METHODS


This was a cluster randomised controlled trial conducted with 1200 students enrolled in the first year of high school. Schools were randomly assigned to: 1. Doubling physical education (PE) classes (3:20 h of PE/week); 2. workshop with the PE teachers; 3. workshop with the PE teachers and doubling the PE classes; and 4. control group (1:40 h of PE/week). We assured that the schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom.
RESULTS


Overall, the intervention was not effective in improving the students' academic performance. However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
CONCLUSIONS


Enhancing the pedagogical skills of the teachers is a promising approach in improving the academic performance of students who failed an academic year.",2020,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","['1200 students enrolled in the first year of high school', 'students enrolled in the first year of high school', 'schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom', 'students who failed an academic year']","['workshop intervention', 'Physical Education Intervention']","[""students' academic performance"", 'academic performance', 'Doubling physical education (PE) classes', 'Academic Performance']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1200.0,0.0519151,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sport Science, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bezerra', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Mauro Virgílio Gomes', 'Initials': 'MVG', 'LastName': 'de Barros', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17124287']
1509,32559474,"Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial.","BACKGROUND


SGLT2 inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These benefits are unlikely to be mediated by improvements in glycaemic control alone. Therefore, we aimed to examine the kidney effects of the SGLT2 inhibitor dapagliflozin in patients with proteinuric kidney disease without diabetes.
METHODS


DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694.
FINDINGS


Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m 2  (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA 1c  was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred.
INTERPRETATION


6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes.
FUNDING


AstraZeneca.",2020,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6.","['Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade', '58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women', 'patients with chronic kidney disease with and without diabetes', 'Between Nov 22, 2017, and April 5, 2019', 'patients with proteinuric kidney disease without diabetes', 'patients with type 2 diabetes', 'non-diabetic patients with chronic kidney disease (DIAMOND', 'patients with chronic kidney disease without diabetes', 'six hospitals in Canada, Malaysia, and the Netherlands']","['dapagliflozin then placebo', 'dapagliflozin', 'SGLT2 inhibitors', 'placebo and then dapagliflozin 10 mg per day or vice versa', 'SGLT2 inhibitor dapagliflozin', 'placebo then dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers', 'median proteinuria', 'percentage change from baseline in 24-h proteinuria', 'mean proteinuria change', 'adverse events', 'hypoglycaemic events', 'changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers', 'Mean baseline mGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",58.0,0.624837,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2  (-9·0 to -4·2; p<0·0001) at week 6.","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, Netherlands.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Muh Geot', 'Initials': 'MG', 'LastName': 'Wong', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30162-5']
1510,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978']
1511,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE


Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women.
METHODS


Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest.
RESULTS


In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed.
CONCLUSION


The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050']
1512,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE


Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.
METHODS


Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.
RESULTS


From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.
CONCLUSIONS


Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016']
1513,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM


Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes.
METHODS


This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial.
RESULTS


At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively).
CONCLUSION


Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003']
1514,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS


Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers.
METHOD


The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing.
RESULTS


The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
CONCLUSIONS


With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028']
1515,32560544,Active Breaks: A Pilot and Feasibility Study to Evaluate the Effectiveness of Physical Activity Levels in a School Based Intervention in an Italian Primary School.,"Background:  The school gives access to children, regardless of age, ethnicity, gender and socio-economic class and can be identified as the key environment in which to promote children's physical activity (PA). The guidelines of the European Union recommend accumulating at least 10-min bouts of PA to reach the daily 60 min. Active breaks (ABs) led by teachers inside the classroom represent a good strategy to promote PA. The aim of this pilot and feasibility study was to evaluate the feasibility and effectiveness in terms of PA level of an AB programme in children aged 8-9 years attending primary school.  Methods:  A pre-post quasi-experimental pilot and feasibility study was performed in two primary school classes, one of which was assigned to a 14-week AB intervention (AB group) and the other to the control group (CG). At baseline and at follow-up, children were monitored for sedentary and motor activity during an entire week using ActiGraph Accelerometer (ActiLife6 wGT3X-BT). The satisfaction of children and teachers was assessed by self-administered questionnaires.  Results:  In the pre-post comparison, AB group ( n  = 16) showed a reduction in the minutes spent in weekly sedentary activity (-168.7 min,  p  > 0.05), an increase in the number of step counts (+14,026.9,  p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%. On the contrary, CG showed a worsening in all variables. ANCOVA analysis, after adjusting for baseline values, showed significant differences between the AB group and CG for time spent in MVPA, percentage of MVPA and step counts. The satisfaction of children and teachers was good. Teachers were able to adapt the AB protocol to the needs of the school curriculum, thus confirming the feasibility of the AB programme.  Conclusions:  This pilot and feasibility study showed the feasibility and effectiveness of the AB protocol and represented the basis for a future controlled trial.",2020,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","['children aged 8-9 years attending primary school', 'Italian Primary School']",['AB programme'],"['number of step counts', 'minutes spent in weekly sedentary activity', 'Physical Activity Levels', 'feasibility and effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2.0,0.0270913,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Leoni', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lorusso', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via Selmi, 3, 40126 Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna Viale Berti Pichat, 5, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124351']
1516,32560745,"Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


There is little information about Coronavirus Disease 2019 (COVID-19) management for critically ill patients. Most of these patients develop acute respiratory distress syndrome (ARDS) due to excessive inflammatory response and the ensuing cytokine storm. Anti-inflammatory drugs including corticosteroids can be used to effectively reduce the effect of this cytokine storm and lung damage. However, corticosteroids can have side effects, so simultaneous administration of immunoglobulin (IV-IG) and interferon-beta can help manage treatment using corticosteroids. Therefore, we designed a trial to test our hypothesis that early administration of dexamethasone in combination with IV-IG and interferon-beta can reduce the effect of the cytokine storm in critically ill patients COVID-19.
TRIAL DESIGN


A phase two multi-center randomized controlled trial (RCT) with three parallel arms (1:1:1 ratio).
PARTICIPANTS


They will be hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan. The age range of patients will be 18-70 years old.
EXCLUSION CRITERIA


the need for intubation; allergy, intolerance, or contraindication to any study drug including dexamethasone, IV-IG, and interferon-beta; pregnancy or lactation; known HIV positive or active hepatitis B or C. The study will be conducted in several hospitals of the Golestan province, Iran.
INTERVENTION AND COMPARATOR


The study subjects will be randomly allocated to three treatment arms: two experimental groups (two arms: Intervention 1 and Intervention 2) and one Control Group, which will be matched for age and sex using frequency matching method. Each eligible patient in the control arm will receive the standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran. Each patient in the Intervention Group 1 will receive the standard treatment for COVID-19 and dexamethasone, at the first 24 hours' time of admission. The intervention begins with the administration of dexamethasone based on the SpO 2  levels. If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration. In Intervention Group 2, the administration of dexamethasone will be started within the first 24 hours' time of admission and will be continued for 48-72 hours and then the SpO 2  level will be checked. Then, if the level of SpO 2  has not improved after that time, IV-IG and interferon-beta will be prescribed as the same dosage as Group 1. If the percentages of the SpO 2  level are between 85 and 90/ 80 and 85/ 75 and 80/ less than 75, the dosages will be 4 mg every 12 hours/ 4 mg every 8 hours/ 8 mg every 12 hours/ 8 mg every 8 hours, respectively. According to the WHO recommendation, all participants will have the best available supportive care with full monitoring.
MAIN OUTCOMES


Primary: An increase in the SpO 2  level to reach more than 90% in each case, which will be assessed by the oximeter. Secondary: The duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time.
RANDOMISATION


Participants will be allocated into either control or intervention groups with a 1:1:1 allocation ratio using a computer random number generator to generate a table of random numbers for simple randomization.
BLINDING (MASKING)


The project's principal investigator (PI) is unblinded. However, the PI will not analyse the data and interpret the results. An unblinded researcher (a pharmacist) will cover the drug's bottles with aluminium foil and prepare them interventions and control drugs in a syringe with a code so that patients are blinded. This person will have no patients contact. The staff and nurses, caring for the patients, will be unblinded for each study group due to the nature of this study. The staff that take outcome measurements will be blinded. The laboratory technicians will also be blinded as well as the statistical team. These study statisticians will have access to coded data and will analyse the data labelled as group X, group Y, and group Z.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The target sample size will be 105 critically ill COVID-19 patients, who will be allocated randomly to the three trial arms with 35 patients in each group.
TRIAL STATUS


Recruitment is ongoing. The study began on April 18 2020 and will be completed June 19 2020. This summary describes protocol version 1; April 2 2020.
TRIAL REGISTRATION


https://www.irct.ir/. Identifier: IRCT20120225009124N4 version 1; Registration date: April 2 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The full protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.",2020,"If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","['hospitalized patients with severe COVID-19 who have positive RT-PCR test and have blood oxygen saturation levels (SpO 2 ) less than 90% and respiratory rate higher than 24 per minute or have involvement of more than 50% of their lung when viewed using computed tomography (CT)-scan', 'critically ill patients', 'critically ill COVID-19 patients', '105 critically ill COVID-19 patients', 'critically ill patients COVID-19', 'The study began on April 18 2020 and will be completed June 19 2020', 'several hospitals of the Golestan province, Iran', 'patients develop acute respiratory distress syndrome (ARDS']","['standard treatment for COVID-19 based on WHO guidelines and the Ministry of the Health and Medical Education (MOHME) of Iran', 'dexamethasone, intravenous immunoglobulin, and interferon-beta', 'dexamethasone', 'corticosteroids', 'standard treatment for COVID-19 and dexamethasone']",['duration of hospital stays; intubation status and the percentage of patients who are free of mechanical ventilation; the mortality rates during hospitalization and one month after the admission time'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",105.0,0.199707,"If the level of SpO 2  does not improve after 24 hours, IV-IG (400 mg/kg once daily for 5 days) and interferon-beta (7 doses every other day) will be prescribed along with dexamethasone administration.","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Abdolahi', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Kaheh', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Golsha', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Khodabakhshi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Khandashpoor', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Besharat', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. s_besharat_gp@yahoo.com.'}, {'ForeName': 'Samane', 'Initials': 'S', 'LastName': 'Tavassoli', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Livani', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sadegh Ali', 'Initials': 'SA', 'LastName': 'Azimi', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Gharib', 'Affiliation': 'Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Peivandi', 'Affiliation': 'Clinical Research Development Center (CRDC), Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Fazel', 'Affiliation': 'Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Hesamaddin', 'Initials': 'H', 'LastName': 'Shirzad-Aski', 'Affiliation': 'Infectious Diseases Research Center, Golestan University of Medical Sciences, Gorgan, Iran. shirzad.hessam1364@gmail.com.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Roshandel', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran. roshandel_md@yahoo.com.'}]",Trials,['10.1186/s13063-020-04499-5']
1517,32560746,Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) may trigger severe pneumonia in coronavirus disease of 2019 (COVID-19) patients through release of damage-associated molecular patterns (DAMPs) and recruitment of neutrophils in the lungs. Activated neutrophils induce inflammation and severe alveolar injury by releasing neutrophil extracellular traps (NETs). The backbones of many DAMPs and NETs are made of extracellular, cell-free DNA decorated with highly toxic compounds such as elastase, myeloperoxidase and citrullinated histones. Dornase alfa is a FDA-approved recombinant human DNAse 1 for the treatment of cystic fibrosis, which cleaves extracellular DNA and may break up cell-free DNA, loosening sticky mucus in the distal airways and reducing NETs-induced toxicity on alveolar pneumocytes. The COVIDornase trial intends to define the impact of aerosolized intra-tracheal dornase alfa administration on the severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
TRIAL DESIGN


COVIDornase is a prospective, randomized, controlled, 2-arm (1:1 ratio), multicentric, open-label clinical trial.
PARTICIPANTS


The study will recruit mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria.
INCLUSION CRITERIA


- Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2  < 300 and PEEP > 5 cmH 2 O); - Intubated for less than 8 days; - With an anticipated duration of mechanical ventilation > 48 hours; - Carrier of an arterial catheter; - For whom 4 PaO 2 /FiO 2  values over the preceding 24 hours are available; NON-INCLUSION CRITERIA: - Known hypersensitivity to dornase alfa or any of its excipients; - Pregnant or breastfeeding status; - Patient under legal protection.
INTERVENTION AND COMPARATOR


Intervention 1, Study group Dornase alfa (Pulmozyme®, Roche, Switzerland) will be administered by aerosol, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days, using a vibrating mesh nebulizer (Aerogen Solo®, Aerogen, Ireland). The remainder of the management will be performed in accordance with good clinical practice, including mechanical ventilation (protective ventilation, PEEP > 5 cmH 2 O, tracheal balloon pressure check every 4 hours or automatic device, 30° head of the bed elevation, tidal volume 6-8mL/kg, plateau pressure < 30 cmH 2 O), neuromuscular blockers if necessary, prone position if PaO 2 /FiO 2  < 150, early enteral nutrition, glycemic control and a sedation protocol based on the RASS score. Intervention 2, Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols.
MAIN OUTCOMES


The primary outcome is the occurrence of at least one grade improvement between D 0  (inclusion) and D 7  in the ARDS scale severity (Berlin criteria). For instance from ""severe"" to ""moderate"" or from ""moderate"" to ""mild"".
RANDOMISATION


All consecutive patients meeting the inclusion criteria will be randomised 1:1 using an eCRF-based, computer-generated randomisation table, either to the dornase alfa arm or to the control arm. An interim analysis will be performed after inclusion of 20 patients. Inclusions may be stopped at the interim analysis per data safety and monitoring board (DSMB) advice, if statistical analyses conclude on the futility or efficacy of the intervention or by other DSMB decision.
BLINDING (MASKING)


The participants and caregivers will not be blinded to study group assignment. Those assessing the outcomes will be blinded to study group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Fifty patients will be randomized to each group, 100 patients in total.
TRIAL STATUS


Protocol version number 2, April 29 th , 2020. Recruitment is ongoing. The trial started recruitment on the 21 st  April 2020. We estimate recruitment will finish August 21 st  2020.
TRIAL REGISTRATION


The trial was registered in ClinicalTrials.gov on 21 April 2020, updated on 8 May 2020. Trial registration number is NCT04355364.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This Letter serves as a summary of the key elements of the full protocol.",2020,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
","[' Adult patient (age ≥ 18 years old); - Hospitalized in ICU; - With severe COVID-19 pneumonia and ARDS according to Berlin criteria (PaO 2 /FiO 2  < 300 and PEEP > 5 cmH 2 O', 'COVID-19 patients', 'Protocol version number 2, April 29 th , 2020', 'Fifty patients will be randomized to each group, 100 patients in total', 'mechanically ventilated patients hospitalized in the intensive care unit (ICU) in the recruiting centres (at the time of writing: The Rothschild foundation hospital in Paris, the Strasbourg university hospitals, and Metz-Thionville hospital) who have been diagnosed with COVID-19 and meet ARDS criteria', 'patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS', '21 April 2020, updated on 8 May 2020']","['aerosolized intra-tracheal dornase alfa administration', 'Dornase alfa (Pulmozyme®, Roche, Switzerland', 'Comparator Patients will receive usual care in accordance with good practice (as detailed above), without aerosols']","['occurrence of at least one grade improvement between D 0  (inclusion) and D 7  in the ARDS scale severity (Berlin criteria', 'Efficacy and safety', 'severity and progression of acute respiratory distress syndrome (ARDS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C1135662', 'cui_str': 'Dornase Alfa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0251564', 'cui_str': 'Pulmozyme'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",50.0,0.257936,"This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.
","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'Biological Resource Center, Interventional Neuroradiology Department, Rothschild Foundation Hospital, Paris, France. jpdesilles@for.paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gregoire', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Cossec', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mophawe', 'Affiliation': 'Clinical Research Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Losser', 'Affiliation': ""CHRU Nancy, Pôle d'Anesthésie-Réanimation, 29 Avenue de Lattre de Tassigny, 54000, Nancy, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lambiotte', 'Affiliation': 'Service de Réanimation Polyvalente, Centre Hospitalier de Valenciennes, Avenue Désandrouin, 59322, Valenciennes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Le Tacon', 'Affiliation': 'CHR Metz-Thionville-Site de Mercy, Service de Réanimation Polyvalente, 1 Allée du Château, 57350, Ars-Laquenexy, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantier', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Engrand', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Trouiller', 'Affiliation': 'Intensive Care Department, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pottecher', 'Affiliation': ""Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation Chirurgicale, 1 Avenue Molière, 67098, Strasbourg, France.""}]",Trials,['10.1186/s13063-020-04488-8']
1518,32562206,Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.,"BACKGROUND AND OBJECTIVE


In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy?
METHODS


The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor.
RESULTS


Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy).
CONCLUSIONS


Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS.
GOV UNIQUE IDENTIFIER


NCT02164864.",2020,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","['patients with atrial fibrillation who underwent percutaneous coronary intervention', 'patients receiving/not receiving a proton pump inhibitor', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation following percutaneous coronary intervention', 'Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline', '2725 patients with atrial fibrillation post-percutaneous coronary intervention to']","['warfarin triple therapy', 'dabigatran dual therapy', 'Dabigatran', 'clopidogrel or ticagrelor', 'Proton Pump Inhibitor', 'warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin', 'proton pump inhibitor', 'Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention']","['risk of major bleeding events', 'risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",2725.0,0.0706981,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Sulzbach (Taunus), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148, Paris, France.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-020-01323-x']
1519,32563116,Screening and brief intervention for lower-risk drug use in primary care: A pilot randomized trial.,"AIMS


The efficacy of screening and brief intervention for lower-risk drug use is unknown. This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
METHODS


We randomly assigned participants identified by screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV). Primary outcome was number of days use of main drug in the past 30 as determined by validated calendar method at 6 months. Analyses were performed using negative binomial regression adjusted for baseline use and main drug.
RESULTS


Of 142 eligible adults, 61(43 %) consented and were randomized. Participant characteristics were: mean age 41; 54 % male; 77 % black. Main drug was cannabis 70 %, cocaine 15 %, prescription opioid 10 %; 7% reported injection drug use and mean days use of main drug (of 30) was 3.4. At 6 months, 93 % completed follow-up and adjusted mean days use of main drug were 6.4 (no BI) vs 2.1 (BNI) (incidence rate ratio, IRR 0.33[0.15-0.74]) and 2.3 (MOTIV) (IRR 0.36[0.15-0.85]).
CONCLUSIONS


BI appears to have efficacy for preventing an increase in drug use in primary care patients with lower-risk use identified by screening. These findings raise the potential that less severe patterns of drug use in primary care may be uniquely amenable to brief intervention and warrant replication.",2020,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
","['Of 142 eligible adults, 61(43 %) consented and were randomized', 'Participant characteristics were: mean age 41; 54 % male; 77 % black', 'lower-risk drug use in primary care', 'primary care patients with lower-risk drug use identified by screening', 'primary care patients with lower-risk use identified by screening']","['brief interventions (BIs', 'screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV', 'screening and brief intervention']",['number of days use of main drug in the past 30 as determined by validated calendar method'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035513', 'cui_str': 'Contraceptive rhythm method'}]",142.0,0.0558587,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertholet', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Bugnon 23A, Lausanne, 1011, Switzerland. Electronic address: Nicolas.Bertholet@chuv.ch.'}, {'ForeName': 'Seville', 'Initials': 'S', 'LastName': 'Meli', 'Affiliation': 'Upstream USA, Cambridge, MA 02140, USA.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: palfai@bu.edu.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: dmcheng@bu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Alford', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: Dan.Alford@bmc.org.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: jbernste@bu.edu.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: jsamet@bu.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lloyd-Travaglini', 'Affiliation': 'Data Coordinating Center, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: clloyd@bu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: rsaitz@bu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108001']
1520,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE


This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
METHODS


Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
RESULTS


During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
CONCLUSION


In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011']
1521,32567439,"Acute and Chronic Effects of SGLT2 Inhibitor Empagliflozin on Renal Oxygenation and Blood Pressure Control in Nondiabetic Normotensive Subjects: A Randomized, Placebo-Controlled Trial.","Background The sodium/glucose cotransporter 2 inhibitor empagliflozin has cardiorenal protective properties through mechanisms beyond glucose control. In this study we assessed whether empagliflozin modifies renal oxygenation as a possible mechanism of renal protection, and determined the metabolic, renal, and hemodynamic effects of empagliflozin in nondiabetic subjects. Methods and Results In this double-blind, randomized, placebo-controlled study, 45 healthy volunteers underwent blood and urine sampling, renal ultrasound, and blood-oxygenation-level-dependent magnetic resonance imaging before and 180 minutes after administration of 10 mg empagliflozin (n=30) or placebo (n=15). These examinations were repeated after 1 month of daily intake. Cortical and medullary renal oxygenation were not affected by the acute or chronic administration of empagliflozin, as determined by 148 renal blood-oxygenation-level-dependent magnetic resonance imaging examinations. Empagliflozin increased glucosuria (24-hour glucosuria at 1 month: +50.1±16.3 g). The acute decrease in proximal sodium reabsorption, as determined by endogenous fractional excretion of lithium (-34.6% versus placebo), was compensated at 1 month by a rise in plasma renin activity (+28.6%) and aldosterone (+55.7%). The 24-hour systolic and diastolic ambulatory blood pressures decreased significantly after 1 month of empagliflozin administration (-5.1 and -2.0 mm Hg, respectively). Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same. Conclusions Empagliflozin has a rapid and significant effect on tubular function, with sustained glucosuria and transient natriuresis in nondiabetic normotensive subjects. These effects favor blood pressure reduction. No acute or sustained changes were found in renal cortical or medullary tissue oxygenation. It remains to be determined whether this is the case in nondiabetic or diabetic patients with congestive heart failure or kidney disease.  REGISTRATION : URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03093103.",2020,"Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same.","['45 healthy volunteers underwent blood and urine sampling, renal ultrasound, and blood-oxygenation-level-dependent magnetic resonance imaging before and 180\xa0minutes after administration of 10 mg', 'nondiabetic or diabetic patients with congestive heart failure or kidney disease', 'Nondiabetic Normotensive Subjects', 'nondiabetic normotensive subjects', 'nondiabetic subjects']","['Placebo', 'empagliflozin', 'SGLT2 Inhibitor Empagliflozin', 'sodium/glucose cotransporter 2 inhibitor empagliflozin', 'Empagliflozin', 'placebo']","['endogenous fractional excretion of lithium', 'plasma renin activity', 'proximal sodium reabsorption', 'renal cortical or medullary tissue oxygenation', 'Cortical and medullary renal oxygenation', 'glucosuria (24-hour glucosuria', 'Serum uric acid levels', '24-hour systolic and diastolic ambulatory blood pressures', 'Renal Oxygenation and Blood Pressure Control', 'hemoglobin', 'blood pressure reduction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0203408', 'cui_str': 'Echography of kidney'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0001629', 'cui_str': 'Adrenal medulla structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",45.0,0.280845,"Serum uric acid levels decreased (-28.4%), hemoglobin increased (+1.7%), and erythropoietin remained the same.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zanchi', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Muller', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Arlène', 'Initials': 'A', 'LastName': 'Ghajarzadeh-Wurzner', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Loncle', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Milani', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dufour', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonny', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Pruijm', 'Affiliation': 'Service of Nephrology and Hypertension Department of Medicine Lausanne University Hospital and University of Lausanne Switzerland.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016173']
1522,32442139,Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions.
OBJECTIVE


The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions.
METHODS


A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program.
RESULTS


This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children's Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started.
CONCLUSIONS


To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/12823.",2020,"Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline, weekly, until the end of the 12-week program.
","['Juvenile Idiopathic Arthritis', '25 female adolescents with JIA who have pain', 'female adolescents with JIA', 'female adolescents (aged 13-18 years) with JIA compared with an']","['yoga and aerobic dance', 'electronic pamphlet control group', 'online yoga training program', 'electronic educational pamphlet', 'electronic pamphlet control', 'yoga training program and an aerobic dance training program', 'online aerobic dance training program', 'Yoga and Aerobic Dance']","['Feasibility (ie, recruitment rate', 'dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the video-conferencing platform', 'Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events', 'health outcomes']","[{'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",25.0,0.0845735,"Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline, weekly, until the end of the 12-week program.
","[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Toupin April', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, The Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Cavallo', 'Affiliation': 'École de Réadaptation, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Proulx', 'Affiliation': 'Canadian Arthritis Patient Alliance, Ottawa, ON, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Ciarán M', 'Initials': 'CM', 'LastName': 'Duffy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'ElHindi', 'Affiliation': 'Statistics Canada, Ottawa, ON, Canada.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Brosseau', 'Affiliation': 'Faculty of Health Sciences, School of Rehabilitation Sciences, University of Ottawa, Ottawa, ON, Canada.'}]",JMIR research protocols,['10.2196/12823']
1523,32442141,Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.,"BACKGROUND


Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations.
OBJECTIVE


This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care.
METHODS


This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons.
RESULTS


Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020.
CONCLUSIONS


This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17939.",2020,We previously developed a prognostic tool (STarT Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision-making using matched treatments.,"['primary care patients with MSK pain', '1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons', 'Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template', 'patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain']","['Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care', 'EMR template (computer-based) housing']","['intention-to-treat analysis is pain intensity', 'physical function and quality of life, and an anonymized EMR audit to capture clinician decision making']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.143061,We previously developed a prognostic tool (STarT Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision-making using matched treatments.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Stefannie', 'Initials': 'S', 'LastName': 'Garvin', 'Affiliation': 'Keele Clinical Trials Unit, Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Keele Clinical Trials Unit, Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Birkinshaw', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Oppong', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van der Windt', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, United Kingdom.'}]",JMIR research protocols,['10.2196/17939']
1524,32442334,Early 3-month treatment with comprehensive physical therapy program restores continence in urinary incontinence patients after radical prostatectomy: A randomized controlled trial.,"AIMS


The objective of this study is to ascertain whether an early three-month treatment with electrotherapy and biofeedback restores continence in urinary incontinence patients after radical prostatectomy (RP).
METHODS


Design: The study performed a randomized, controlled trial of parallel and open groups. Configuration: Secondary care, urology department of a university hospital complex.
PARTICIPANTS


Patients sent for RP due to prostate cancer (n = 60), 47 patients finally completed the study.
INTERVENTIONS


The treatment group (TG) received physiotherapy consisting of electrotherapy and biofeedback, 3 days a week for 3 months, while the control group (CG) received no specific treatment. Both groups received a guide to perform pelvic floor exercises at home. The measurement instruments used were the 1- and 24-hour pad tests and the International Consultation on Incontinence Questionnaire Short-Form. The recording method used was a micturition (urinary) diary.
RESULTS


The results of the 1-hour pad test (PT) show statistically significant differences between groups at 3 months (P = .001) and 6 months (P = .001), in favor of those in the TG. Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
CONCLUSIONS


An early physiotherapy program helps RP patients with urinary incontinence recover continence after 3 months. Moreover, they lead a better quality life.",2020,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","['urinary incontinence patients after radical prostatectomy', 'Patients sent for RP\xa0due to prostate cancer (n\u2009=\u200960), 47 patients finally completed the study', 'urinary incontinence patients after radical prostatectomy (RP']","['Configuration', 'guide to perform pelvic floor exercises at home', 'physiotherapy program', 'control group (CG) received no specific treatment', 'comprehensive physical therapy program restores continence', 'electrotherapy and biofeedback restores continence', 'physiotherapy consisting of electrotherapy\xa0and biofeedback']","['quality life', 'urinary incontinence recover continence']","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]",,0.0525782,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Soto González', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Da Cuña Carrera', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gutiérrez Nieto', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'López García', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ojea Calvo', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lantarón Caeiro', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}]",Neurourology and urodynamics,['10.1002/nau.24389']
1525,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903']
1526,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045']
1527,32444161,Using a Mobile Phone Application Versus Telephone Assistance During Cardiopulmonary Resuscitation: A Randomized Comparative Study.,"INTRODUCTION


In recent years, the way CPR instructions are given has changed because of the development of new technology that allows bystanders who witness a cardiac arrest to be guided in performing CPR. This study aimed to compare the effectiveness of using a mobile phone application (app) versus telephone operator assistance in performing cardiopulmonary resuscitation (CPR) techniques in simulated settings.
METHODS


A comparative study was performed with 2 intervention groups: (1) mobile phone app and (2) telephone assistance. A total of 128 students participated and were distributed randomly into each intervention group. A CPR observation checklist and standard CPR quality parameter measurements were used for data collection.
RESULTS


The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.81; P < 0.05), asking for help (X 2 (1) = 66.07; P < 0.05), opening of airways (X 2 (1) = 12.03; P < 0.05), checking for breathing (X 2 (1) = 6.10; P < 0.05), and contacting emergency services (X 2 (1) = 12.41; P < 0.05). Regarding the skill level of CPR, no statistically significant differences were found when comparing the 2 intervention groups (X 2 (1) = 0.91; P = 0.33). As for the parameters measured, there were only statistically significant differences found in the item compression fraction (U = 1,593.00; Z = -2.16; P < 0.05), with the group that used the app obtaining better results.
DISCUSSION


Better outcomes were observed in recognizing if the area was safe, asking for help, opening up the airways, checking for breathing, and calling emergency services in the mobile phone app group. However, the results indicated that there were no differences in the CPR parameters, except compression fraction, when the app was used as opposed to being guided by telephone.",2020,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","['128 students participated', 'During Cardiopulmonary Resuscitation']","['mobile phone application (app) versus telephone operator assistance', 'Mobile Phone Application Versus Telephone Assistance', 'mobile phone app and (2) telephone assistance']","['CPR parameters, except compression fraction', 'contacting emergency services', 'item compression fraction', 'checking for breathing', 'opening of airways']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",128.0,0.0187919,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","[{'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Garrido-Molina', 'Affiliation': ''}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'García-Viola', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.015']
1528,32566130,Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia.,"Background:  Speech and language therapy is typically initiated reactively after a child shows delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).   Method : Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing.  Results :  All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG.  Discussion:  Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization.  Trial registration:  ClinicalTrials.gov NCT03838016 (12  th  February 2019).",2019,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","['infants with classic galactosemia', 'children with CG', 'Infants with classic galactosemia (CG', 'Method : Five children with CG, otherwise healthy, participated in the BBC from approximately 2 to 24 months of age']","['Babble Boot Camp', 'proactive speech and language treatment', 'control receiving conventional management', 'innovative proactive speech and language intervention program, the Babble Boot Camp (BBC', ':  Speech or language therapy']","['speech sound production, expressive language, and communication milestones', 'developmental milestones in communication, motor, and cognition', 'speech sound production complexity in babble and speech and expressive vocabulary size', 'higher communication and personal-social skills', 'higher speech sound skills', 'prespeech, speech, and language stimulation and expansion activities']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0268151', 'cui_str': 'Deficiency of UDPglucose-hexose-1-phosphate uridylyltransferase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023017', 'cui_str': 'Language therapy'}]","[{'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0589217', 'cui_str': 'Language stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",5.0,0.032084,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Potter', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Donenfeld-Peled', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Finestack', 'Affiliation': 'Department of Speech-Language-Hearing Services, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stoel-Gammon', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Bruce', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Vose', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Eng', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olds', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'VanDam', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",F1000Research,['10.12688/f1000research.18062.4']
1529,32566763,A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 ( b  = -2.75, 95% CI -4.00, -1.50) and GAD-7 ( b  = -2.79, 95% CI -4.00, -1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm's outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.",2020,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health.","['Three-hundred and sixty-one participants', 'participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration']","['digital interventions', '2:1 (iCBT intervention: waiting-list) allocation', 'internet-delivered cognitive behavioural therapy (iCBT', 'iCBT']","['probability of cost-effectiveness', 'PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment', 'quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use', 'GAD-7', 'depression and anxiety']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",361.0,0.15685,"Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eilert', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'HEDS, ScHARR, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Jell', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sollesse', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire, England.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'Clinical Research & Innovation, SilverCloud Health, Dublin, Ireland.'}]",NPJ digital medicine,['10.1038/s41746-020-0293-8']
1530,32567679,Fitness and strength responses to distinct exercise modes in twins: Studies of Twin Responses to Understand Exercise as a THerapy (STRUETH) study.,"KEY POINTS


Exercise is considered medicine; however, the individual degree of responsiveness to a standardized dose of exercise is idiosyncratic. Individual responsiveness between distinct exercise modalities and the genetic/environmental contributions to exercise response are not well understood. In this novel randomized cross-over design study, monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training, separated by a 3 month washout period, aiming to assess training responses in strength and fitness outcomes to dichotomous training modalities, as well as the genetic/environmental contributions to exercise response. Our findings indicate that (i) individual responsiveness differs between exercise modalities; (ii) low-responders to one mode may be 'rescued' by switching to an alternate mode of exercise; and (iii) genes may not play as large a role, as previously estimated from cross-sectional data, for exercise training adaptation. The present study has implications for those charged with optimizing the benefits of exercise by means of individualizing the exercise prescription.
ABSTRACT


Exercise response is idiosyncratic, although the degree of responsiveness, concordance in response between modalities and genetic contribution to responsiveness are not well understood. We investigated this using a novel randomized cross-over design of dichotomous exercise interventions in mono-(MZ) and di-zygotic (DZ) twin pairs. We studied strength (1RM) and fitness (    V   ̇   O   2   max      ) responses in 84 same-sex untrained twins (30 MZ, 12 DZ pairs; 24.9 ± 5.4 years). Twins, as pairs, underwent 3 months of resistance (RES) and endurance (END) training, separated by a 3 month washout period. Training responses and genetic/environmental contributions to responses were assessed. Leg strength 1RM increased following RES but not END (△47 ± 29 vs. 3 ± 26 kg; P < 0.001), whereas    V   ̇   O   2   max      increased following END but not RES (△0.25 ± 0.26 vs. 0.04 ± 0.25 L min -1  ; P < 0.001). A higher percentage of individuals responded to RES for strength and to END for    V   ̇   O   2   max      (P < 0.0001). Within-individual responses to each mode were not correlated (P > 0.05). Cross-sectional intraclass correlations were higher for MZ than DZ pairs for all variables, largely as a result of shared environment. Following training, MZ, but not DZ pairs, were significantly correlated for strength change to RES (r MZ   = 0.62, P = 0.002) and END (r MZ   = 0.36, P = 0.04), and for    V   ̇   O   2   max      change to END (L min -1  , r MZ   = 0.45, P = 0.02) with a mixture of unshared/shared environmental contributions. Our findings indicate that individual responsiveness differs between modalities and low-responders to one mode may be 'rescued' by switching to an alternate mode. Additionally, genes may not play as large a role as previously estimated from cross-sectional data for training adaptation, and/or cross-sectional data do not reflect longitudinal training effects. The present study has implications for optimizing the individualization of exercise prescription.",2020,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"['84 same-sex untrained twins (30MZ, 12DZ pairs; 24.9\xa0±\xa05.4\xa0yr', 'mono-(MZ) and di-zygotic (DZ) twin pairs', 'monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training', 'twins']","['495·In', 'dichotomous exercise interventions']","['Leg strength 1RM', 'resistance (RES) and endurance (END) training', 'strength change to RES', 'strength (1RM) and fitness (VO 2  max) responses']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0319865,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}]",The Journal of physiology,['10.1113/JP280048']
1531,32568108,Carbidopa and Levodopa Extended Release Capsules (Rytary®) in Patients with and without Troublesome and Non-Troublesome Dyskinesia.,"BACKGROUND


Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER, Rytary®) capsules are designed to combine both immediate and extended release pharmacokinetics. In the phase 3, randomized, double-blind, ADVANCE-PD trial, patients randomized to CD-LD ER experienced a 1.17-hour greater reduction in OFF time compared to patients randomized to CD-LD IR (p < 0.0001).
OBJECTIVE


To compare CD-LD IR optimization to CD-LD ER conversion based on patient dyskinesia status at baseline using data from the ADVANCE-PD trial.
METHODS


This was a retrospective analysis of the ADVANCE-PD study. Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia Only (NTDO), and 3) those who had Troublesome Dyskinesia (TD).
RESULTS


Comparative reductions in OFF time favoring CD-LD ER over CD-LD IR were similar for the ND (-1.08 h, p = 0.0071, n = 183) and NTDO (-1.12 h, p = 0.0104, n = 131) groups, and smaller for the TD group (-0.82 h, p = 0.2382, n = 79). Reductions in OFF time for both CD-LD ER conversion and CD-LD IR adjustment were largest within the ND group and smallest within the TD group (CD-LD ER: ND -2.86 h, NTDO -2.11 h, TD -1.36 h; CD-LD IR: ND -1.78 h, NTDO -0.99 h, TD -0.55 h).
CONCLUSION


Responses to both CD-LD IR adjustment and CD-LD ER conversion depended on baseline dyskinesia status. Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups. In the TD group, comparing CD-LD ER conversion to CD-LD IR optimization, benefits were still observed, but there was less reduction in OFF time, less reduction in troublesome dyskinesia, and fewer patients self-rated themselves much or very much improved than in the ND and NTDO groups. These data suggest that in clinical practice, the best chances for success with conversion from CD-LD IR to CD-LD ER are in patients without TD.",2020,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"['Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia', 'Patients with and without Troublesome and Non-Troublesome Dyskinesia']","['CD-LD IR adjustment and CD-LD ER conversion', 'ND', 'Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER, Rytary®) capsules', 'CD-LD IR optimization to CD-LD ER conversion', 'CD-LD ER', 'Carbidopa and Levodopa Extended Release Capsules (Rytary®']","['troublesome dyskinesia', 'CD-LD IR', 'OFF time', 'OFF time favoring CD-LD ER over CD-LD IR', 'Troublesome Dyskinesia (TD', 'OFF time for both CD-LD ER conversion and CD-LD IR adjustment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3872096', 'cui_str': 'Rytary'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",,0.017814,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Zeitlin', 'Affiliation': 'Quartesian, Princeton, NJ, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""D'Souza"", 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202010']
1532,32563846,Depression history as a predictor of outcomes during buprenorphine-naloxone treatment of prescription opioid use disorder.,"BACKGROUND


In the multi-site Prescription Opioid Addiction Treatment Study (POATS), the best predictor of successful opioid use outcome was lifetime diagnosis of major depressive disorder. The primary aim of this secondary analysis of data from POATS was to empirically assess two explanations for this counterintuitive finding.
METHODS


The POATS study was a national, 10-site randomized controlled trial (N = 360 enrolled in the 12-week buprenorphine-naloxone maintenance treatment phase) sponsored by the NIDA Clinical Trials Network. We evaluated how the presence of a history of depression influences opioid use outcome (negative urine drug assays). Using adjusted logistic regression models, we tested the hypotheses that 1) a reduction in depressive symptoms and 2) greater motivation and engagement in treatment account for the association between depression history and good treatment outcome.
RESULTS


Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns). Reporting a goal of opioid abstinence at treatment entry was also not associated with outcomes (aOR = 1.39, ns); however, mutual-help group participation was associated with good treatment outcomes (aOR = 1.67, p <.05). In each of these models, lifetime major depressive disorder remained associated with good outcomes (aORs = 1.63-1.82, ps = .01-.055).
CONCLUSIONS


Findings are consistent with the premise that greater engagement in treatment is associated with good opioid outcomes. Nevertheless, depression history continues to be associated with good opioid outcomes in adjusted models. More research is needed to understand how these factors could improve treatment outcomes for those with opioid use disorder.",2020,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","['prescription opioid use disorder', '360 enrolled in the 12-week', 'maintenance treatment phase) sponsored by the NIDA Clinical Trials Network']",['buprenorphine-naloxone'],"['lifetime major depressive disorder', 'depressive symptoms']","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0068218', 'cui_str': 'N-nitrosoiminodiacetic acid'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",360.0,0.0809725,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Peckham', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA. Electronic address: adpeckham@mclean.harvard.edu.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108122']
1533,32563847,Longitudinal analysis of alcohol use and intimate partner violence perpetration among men with HIV in northern Vietnam.,"BACKGROUND


Alcohol use is a known risk factor for male-perpetrated intimate partner violence (IPV), although few studies have been conducted globally and among men with HIV (MWH). We estimated the longitudinal effects of alcohol use on IPV perpetration among MWH.
METHODS


This study is a secondary analysis of randomized controlled trial data among male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam. Analyses were restricted to male participants who were married/cohabitating (N = 313). Alcohol use was assessed as proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire. Multilevel modeling was used to estimate the effects of higher versus lower average alcohol use on IPV perpetration (between-person effects) and the effects of time-specific deviations in alcohol use on IPV perpetration (within-person effects).
RESULTS


Participants with higher average proportion days alcohol abstinent had decreased odds of IPV perpetration (adjusted Odds Ratio [aOR] = 0.43, p = 0.03) and those with higher average heavy drinking and AUD had increased odds of IPV perpetration (Heavy drinking: aOR = 1.05, p = 0.002; AUD: aOR = 4.74, p < 0.0001). Time-specific increases in proportion days alcohol abstinent were associated with decreased odds of IPV perpetration (aOR = 0.39, p = 0.02) and time-specific increases in AUD were associated with increased odds of IPV perpetration (aOR = 2.95, p = 0.001). Within-person effects for heavy drinking were non-significant.
CONCLUSIONS


Alcohol use is associated with IPV perpetration among Vietnamese men with HIV. In this context, AUD and frequent drinking are stronger correlates of IPV perpetration as compared to heavy drinking.",2020,"Within-person effects for heavy drinking were non-significant.
CONCLUSIONS


Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","['men with HIV in northern Vietnam', 'men with HIV (MWH', 'Vietnamese men with HIV', 'male participants who were married/cohabitating (N = 313', 'male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam', 'male-perpetrated intimate partner violence (IPV']",[],"['proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire', 'time-specific increases in AUD', 'Time-specific increases in proportion days alcohol abstinent', 'IPV perpetration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",313.0,0.0196213,"Within-person effects for heavy drinking were non-significant.
CONCLUSIONS


Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA. Electronic address: rhershow@live.unc.edu.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108098']
1534,32564051,Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study.,"BACKGROUND This study was carried out to compare the therapeutic efficacy of extracorporeal shock wave (ESW) and ultrashort wave (UW) for temporomandibular joint disorder (TMD). MATERIAL AND METHODS A total of 80 patients with myofascial pain and TMD were enrolled in this study. The subjects were randomized to receive ESW or UW treatments. Patients in the ESW group received 1 ESW treatment for 4 weeks and patients in the US group were given US treatment once a day for 5 days per week for 4 weeks. The pain was measured using visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO) before and 4 weeks after the treatments. Other parameters assessed included functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI). RESULTS After therapy, VAS, MMO, MM, JN, JP, and DI in ESW group, and VAS in UW group were significantly improved (P<0.05) as compared to before therapy. VAS, MMO, and the functional indexes of temporomandibular joint in the ESW group were significantly better than those in the UW group (1.79 vs. 2.00, 3.23 vs. 2.03, 1.79 vs. 2.41, 1.45 vs. 2.27, 1.55 vs. 2.59, and 3.30 vs. 4.79, respectively. P<0.05). CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.",2020,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"['temporomandibular joint disorder (TMD', '80 patients with myofascial pain and TMD']","['extracorporeal shock wave (ESW) and ultrashort wave (UW', 'ESW', 'Ultrashort Wave and Extracorporeal Shock Wave']","['VAS, MMO, MM, JN, JP, and DI', 'functional indexes of temporomandibular joint such as mandibular movement (MM), joint noise (JN), joint press (JP), and disability index (DI', 'visual analog scale (VAS) and mouth opening was determined as pain-free maximum mouth opening (MMO', 'pain', 'functional indexes of temporomandibular joint and mouth opening limit', 'VAS, MMO, and the functional indexes of temporomandibular joint']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0277829', 'cui_str': 'Noises in joint'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",80.0,0.0591111,CONCLUSIONS ESW significantly reduces pain and improves the functional indexes of temporomandibular joint and mouth opening limit for TMD patients as compared with UW therapy.,"[{'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923461']
1535,32564128,A randomized phase II trial of cisplatin plus gemcitabine versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT0703).,"PURPOSE


This study evaluated the efficacy and safety of platinum plus gemcitabine (P/G) combinations as postoperative adjuvant chemotherapies for non-small cell lung cancer.
METHODS


Patients with postoperative stage IB-IIIA non-small cell lung cancer were randomly assigned to receive either cisplatin plus gemcitabine (GP arm) or carboplatin plus gemcitabine (GC arm) every 3 weeks for four cycles. The primary endpoint was 2-year disease-free survival (DFS). Secondary endpoints were safety, feasibility, overall survival (OS), and biomarker analyses.
RESULTS


A total of 102 patients were randomized (stage IB, 22%; II, 36%; IIIA, 42%; histology: 74% adenocarcinoma). Of the 51 patients in each arm, 37 (73%) completed 4 cycles. During follow-up (median 5.8 years; range 0.1-9.7 years), estimated DFS and OS rates at 2 years were 59.6% and 86.3% with GP and 68.0% and 86.3% with GC, respectively. No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC. Hematological toxic effects were comparable and non-hematological toxic effects were infrequent. DFS was significantly higher in the excision repair cross-complementation group 1 (ERCC1)-low group than in the ERCC1-high group for the GP arm (P = 0.045).
CONCLUSION


Both P/G combination regimens were feasible and well-tolerated, and thus may represent valid options for postoperative adjuvant treatment of non-small cell lung cancer. Although no significant differences in DFS were evident between regimens, the present data favor the adoption of GC for further evaluation.
CLINICAL TRIAL REGISTRATION


UMIN-CTR ( https://www.umin.ac.jp/ctr/ ) identifier: UMIN000000913.",2020,"No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC.","['102 patients', 'patients with completely resected non-small cell lung cancer', 'Patients with postoperative stage IB-IIIA non-small cell lung cancer']","['cisplatin plus gemcitabine', 'platinum plus gemcitabine (P/G) combinations', 'cisplatin plus gemcitabine (GP arm) or carboplatin plus gemcitabine (GC arm', 'carboplatin plus gemcitabine']","['safety, feasibility, overall survival (OS), and biomarker analyses', '5-year DFS rates', 'feasible and well-tolerated', 'DFS', 'estimated DFS and OS rates', 'efficacy and safety', 'hematological toxic effects', '2-year disease-free survival (DFS', 'Hematological toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",102.0,0.116844,"No significant difference in DFS was noted between arms (P = 0.163), although 3-, 4-, and 5-year DFS rates were higher with GC.","[{'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan. s1004fuku@gmail.com.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Oizumi', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Sukoh', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Nakano', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, 003-0804, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fuke', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sakakibara-Konishi', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takamura', 'Affiliation': 'Department of Respiratory Medicine, Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Obihiro-Kosei General Hospital, Obihiro, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Nishigaki', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Akie', 'Affiliation': 'Department of Respiratory Medicine, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Toraji', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Isobe', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Dosaka-Akita', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04104-1']
1536,32565534,Use of Various Doses of S-Ketamine in Treatment of Depression and Pain in Cervical Carcinoma Patients with Mild/Moderate Depression After Laparoscopic Total Hysterectomy.,"BACKGROUND This study investigated the effects of various doses of S-ketamine on depression and pain management of cervical carcinoma patients with mild/moderate depression. MATERIAL AND METHODS This randomized, double-blind, controlled study included 417 cervical carcinoma patients who received laparoscopic modified radical hysterectomy from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24). All patients were randomized into 4 groups: 1) the control group, 2) the racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine group. Pain was assessed using the Visual Analogue Score (VAS), and depression was assessed using theHAMD-17 score. Serum levels of BDNF and 5-HT were measured. RESULTS The 4 groups of patients showed no significant differences in operation time, bleeding volume, hospitalization duration, or complications. The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group. The high-dose S-ketamine group showed significantly higher serum BDNF and 5-HT levels at 1 day and 3 days after surgery. However, 1 week after surgery, no difference was observed in any of the treatment groups. CONCLUSIONS At subanesthetic dose, both 0.5 mg/kg and 0.25 mg/kg S-ketamine improved short-term depression and pain for cervical carcinoma patients after surgery, and the effects were better than with the same dose of racemic ketamine.",2020,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","['cervical carcinoma patients after surgery', 'cervical carcinoma patients with mild/moderate depression', 'from April 2015 to July 2018 and who also had mild/moderate depression symptoms based on HAMD-17 scores (8~24', 'Cervical Carcinoma Patients with Mild/Moderate Depression', '417 cervical carcinoma patients who received']","['racemic ketamine group, 3) the high-dose S-ketamine group; and 4) the low-dose S-ketamine', 'racemic ketamine', 'ketamine', 'laparoscopic modified radical hysterectomy', 'S-ketamine', 'S-Ketamine']","['short-term depression and pain', 'serum BDNF and 5-HT levels', 'Pain', 'Depression and Pain', 'Visual Analogue Score (VAS), and depression', 'Serum levels of BDNF and 5-HT', 'VAS and HAMD-17 scores', 'depression and pain management', 'operation time, bleeding volume, hospitalization duration, or complications']","[{'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5191297', 'cui_str': '417'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0559248', 'cui_str': 'Modified radical'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",417.0,0.0808004,"The high-dose S-ketamine group showed significantly lower VAS and HAMD-17 scores than all other groups at 1 day and 3 days postoperatively, but no differences were observed in the low-dose S-ketamine group and the racemic ketamine group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Ninth People's Hospital of Suzhou, Suzhou, Jiangsu, China (mainland).""}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Xishan People's Hospital, Wuxi, Jiangsu, China (mainland).""}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Shanghai Gongli Hospital, Second Military Medical University, Shanghai, China (mainland).'}, {'ForeName': 'Peirong', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (TCM), Shanghai, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922028']
1537,32568935,Apoyo con Cariño: A Qualitative Analysis of a Palliative Care-Focused Lay Patient Navigation Intervention for Hispanics With Advanced Cancer.,"A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado. Five home visits were delivered over 3 months to 112 patients assigned to the randomized controlled trial's intervention arm. Grounded in core Hispanic values, visits addressed palliative care domains (advance care planning, pain/symptom management, and hospice utilization). To describe the content of patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients. Based on previous work, codes were established a priori to identify ways patient navigators help patients/family caregivers. Key words and comments from field notes were classified into themes using ATLAS.ti and additional codes established. Nine common themes and exemplars describing the lay patient navigator role are described: activation/empowerment, advocacy, awareness, access, building rapport, providing support, exploring barriers, symptom screening, and the patient experience. Patient navigators used advocacy, activation, education, and motivational interviewing to address patient/family concerns and reduce barriers to quality palliative care in urban and rural settings. Adapting and implementing this model across cultures has potential to improve palliative care access to underserved populations.",2020,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"['Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado', ""patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients"", 'Hispanics With Advanced Cancer', 'urban and rural settings']","['culturally tailored intervention', 'Palliative Care-Focused Lay Patient Navigation Intervention']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]",[],,0.0265818,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"[{'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Fink', 'Affiliation': 'Regina M. Fink, PhD, APRN, CHPN, FAAN, is professor and codirector, Interprofessional Master of Science in Palliative Care Program, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Danielle M. Kline, MS, is senior professional research assistant, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Shaunna Siler, PhD, RN, is palliative care & aging research fellow and T-32 scholar, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Stacy M. Fischer, MD, is associate professor, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Kline', 'Affiliation': ''}, {'ForeName': 'Shaunna', 'Initials': 'S', 'LastName': 'Siler', 'Affiliation': ''}, {'ForeName': 'Stacy M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000666']
1538,32569164,Evaluation of clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of acute respiratory distress syndrome.,"INTRODUCTION


Acute respiratory distress syndrome (ARDS) is a common disease in critically ill patients that has a high incidence and mortality rate worldwide. At present, there is no specific treatment for ARDS. Traditional Chinese medicine has been shown to have good potential in preventing and treating ARDS, especially in reducing the dosages of Western medicines and therefore, adverse drug reactions. The purpose of this study is to compare the clinical efficacy of integrated Chinese and Western medicine to that of Western medicine alone in the treatment of ARDS.
METHODS


We are proposing a prospective, multicenter, randomized, double-blind, placebo-controlled study in which 110 eligible patients would be enrolled and randomly divided into a Western medicine treatment group and an integrated Chinese and Western medicine treatment group. After 2 weeks of interventions and 1 year of follow-up, the clinical efficacy and safety of Jiawei qianyang dan in ARDS patients would be observed. The outcomes measured would include the Traditional Chinese medicine symptom score, the oxygenation index (PɑO2/FiO2), extravascular pulmonary water index, duration of mechanical ventilation, number of ICU hospitalization days, and the 28-day mortality rate for the 2 groups before and after treatment. The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated.
DISCUSSION


In this study, we aim to demonstrate the greater clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of ARDS compared to that of Western medicine alone. In order to do this, we hope to provide evidence for the clinically supportive effect of the Jiawei qianyang dan in the treatment of ARDS and therefore demonstrate a more effective treatment.",2020,"The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated.
","['acute respiratory distress syndrome', '110 eligible patients']","['placebo', 'integrated traditional Chinese and Western medicine', 'Western medicine treatment group and an integrated Chinese and Western medicine treatment group', 'integrated Chinese and Western medicine']","['mortality rate, respiratory failure mortality rate, and readmission rate', 'Traditional Chinese medicine symptom score, the oxygenation index (PɑO2/FiO2), extravascular pulmonary water index, duration of mechanical ventilation, number of ICU hospitalization days, and the 28-day mortality rate']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",110.0,0.042412,"The all-cause mortality rate, respiratory failure mortality rate, and readmission rate after 1 year of follow-up will be statistically analyzed and safety will be evaluated.
","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Kunlan', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ding', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000020341']
1539,32569854,Improving imagery rescripting treatments: Comparing an active versus passive approach.,"BACKGROUND AND OBJECTIVES


In imagery rescripting (ImRs), aversive mental images are modified to reduce symptoms in a variety of psychological disorders. However, uniform guidelines on how to optimally implement ImRs do currently not exist. It remains unclear whether therapists should stimulate patients to imagine themselves to actively intervene within the new image, or whether they may imagine helpers to change the situation. We aimed to compare these two variants of ImRs within an analogue experimental setting.
METHODS


After having watched an aversive film, one-hundred participants were randomly assigned to active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC). Participants were either instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P).
RESULTS


Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy. Conditions did not differ regarding the number of film-related intrusive memories.
LIMITATIONS


As a convenience sample was investigated, results cannot be generalized to clinical samples.
CONCLUSION


Even though differences regarding symptomatic outcome could not be detected, ImRs-P was experienced as less distressing than ImRs-A. Results suggest that both ImRs lead to different processes during the intervention than mere exposure. Compared to IRE, ImRs increases mastery with ImRs-A and ImRs-P being equally effective.",2020,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","['After having watched an aversive film, one-hundred participants']","['active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC', 'instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P']",['number of film-related intrusive memories'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",100.0,0.0317839,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","[{'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Siegesleitner', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Strohm', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Wittekind', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: anna.kunze@psy.lmu.de.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101578']
1540,32570700,Acute Effects of a Whole Body Vibration Session on the Vibration Perception Threshold in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND


Type 2 Diabetes Mellitus (T2DM) is a chronic disease that affects millions of people, and according to the International Diabetes Federation, 46.5% of people have undiagnosed diabetes. One of the most common complications of diabetes mellitus is loss of peripheral sensation. Whole Body Vibration (WBV) is a therapy, and it would be interesting to know if it can be considered as a training method to improve the Vibration Perception Threshold (VPT). The aim of the study is to verify whether there are really acute effects on the VPT after a WBV training session in people with T2DM.
METHODS


Ninety people with T2DM (56 men and 34 women) were randomly allocated to two groups: the WBV group and the placebo group. The ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device.
RESULTS


After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
CONCLUSIONS


Vibration perception threshold is increased after a WBV training session in people with T2DM, compared to a placebo group.",2020,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","['ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device', 'Patients with Type 2 Diabetes Mellitus', 'people with T2DM', 'Ninety people with T2DM (56 men and 34 women']","['Whole Body Vibration Session', 'placebo', 'Whole Body Vibration (WBV']","['VPT', 'Vibration Perception Threshold']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",90.0,0.0272834,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Dominguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Hernandez-Mocholi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Gordillo', 'Affiliation': 'Facultad de Administración y Negocios, Universidad Autónoma de Chile, sede Talca 3467987, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, 28943 Madrid, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Jose Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124356']
1541,32445052,"PPARγ activation by pioglitazone does not suppress cravings for alcohol, and is associated with a risk of myopathy in treatment seeking alcohol dependent patients: a randomized controlled proof of principle study.","RATIONALE


Proinflammatory processes have been implicated in alcohol addiction, craving, and relapse, while studies in experimental animals have suggested that activation of peroxisome proliferator-activated receptor gamma (PPARγ) inhibits proinflammatory signaling. Accordingly, it is hypothesized that medications with PPARγ activity may have therapeutic potential in alcohol dependence.
OBJECTIVES


We conducted a double-blind, placebo-controlled mechanistic proof of principle study in alcohol-dependent inpatients to investigate the effect of pioglitazone on alcohol craving.
METHODS


Participants were treated for withdrawal, if needed, and then randomized to pioglitazone (target dose 45 mg/day) or placebo. Once at target dose, they completed two experimental manipulations: guided imagery, which used personalized auditory scripts to induce alcohol cravings, and a low-dose challenge with i.v. lipopolysaccharide (LPS; 0.8 ng/kg) or placebo, on two separate sessions, in counterbalanced order. Behavioral and endocrine responses as well as CSF levels of proinflammatory cytokines were evaluated.
RESULTS


The study was prematurely terminated after randomization of 16 subjects, following an independent review that established a high risk of myopathy in the active treatment group. Analysis of those who completed the study indicated that pioglitazone was associated with elevated, rather than suppressed alcohol cravings in response to alcohol-associated stimuli. LPS did not induce cravings for alcohol and thus did not lend itself to evaluating pioglitazone effects; however, pioglitazone increased the neuroendocrine stress response to LPS. CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
CONCLUSIONS


Both safety and efficacy biomarker data suggest that pioglitazone lacks potential as a medication for the treatment of alcohol dependence.
CLINICAL TRIAL REGISTRATION


NCT01631630.",2020,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
",['Participants'],"['pioglitazone', 'LPS', 'lipopolysaccharide', 'placebo']","['alcohol cravings', 'CSF levels of proinflammatory cytokines', 'Behavioral and endocrine responses', 'CSF levels of IL-6, TNF-α, or MCP-1']",[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}]",,0.162741,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA. melanies@mail.nih.gov.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Umhau', 'Affiliation': 'Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration, Washington, DC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kwako', 'Affiliation': 'Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'George', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}]",Psychopharmacology,['10.1007/s00213-020-05540-w']
1542,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1543,32445670,Long-term safety and efficacy of subcutaneous C1-inhibitor in older patients with hereditary angioedema.,"BACKGROUND


Patients aged 65 years and older with hereditary angioedema (HAE) owing to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and are at higher risk for treatment-related adverse events (AEs) because of comorbidities and polypharmacy.
OBJECTIVE


To investigate the safety and efficacy of subcutaneous C1 esterase inhibitor (C1-INH) in patients aged 65 years and older treated in an open-label extension of a phase 3 trial.
METHODS


Eligible patients (≥4 attacks for more than 2 consecutive months) were randomized to receive twice-weekly subcutaneous C1-INH with a dosage of 40 IU/kg or 60 IU/kg for 52 to 140 weeks. Safety end points and efficacy outcomes were evaluated for patients aged 65 years and above and younger than 65 years.
RESULTS


Of the 126 patients treated, 10 were 65 years and older (mean age [range], 68 [65-72 years]). A total of 8 of 10 patients had multiple comorbidities, and 6 of these 10 patients were taking more than 5 non-HAE-related drugs concomitantly. AEs occurring in more than 1 patient included injection site bruising (n = 2, related), injection site pain (n = 2, related), urinary tract infection (n = 2, unrelated), and diarrhea (n = 2, unrelated). No thromboembolic events or cases of anaphylaxis were reported. Two patients aged 65 years and older experienced unrelated serious AEs (dehydration and hypokalemia in 1 and pneumonia and an HAE attack leading to hospitalization in another). A total of 6 of 9 evaluable patients were responders, with a greater than or equal to 50% reduction in HAE attacks vs prestudy; 6 of 10 patients had less than 1 attack over 4 weeks and 3 were attack-free (median attack rate, 0.52 attacks per month).
CONCLUSION


Subcutaneous C1-INH was well-tolerated and effective in the management of HAE in patients aged 65 years and older with multiple comorbid conditions and polypharmacy.",2020,No thromboembolic events or cases of anaphylaxis were reported.,"['126 subjects treated', 'Patients ≥65 years old with hereditary angioedema (HAE', 'Eligible patients (≥4 attacks over 2 consecutive months', 'patients ≥65 years old treated in an open-label extension of a phase 3 trial', 'Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another', 'patients aged ≥65 and <65 years', 'Older Patients With Hereditary Angioedema', 'subjects ≥65 years old with multiple comorbid conditions and polypharmacy', 'Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly', ' 10 were ≥65 years old (mean age [range], 68 [65-72 years']","['Subcutaneous C1-Inhibitor', 'C1-INH (SC', 'subcutaneous (SC) C1-INH']","['Safety endpoints and efficacy outcomes', 'tolerated and effective', 'urinary tract infection', 'safety and efficacy', 'thromboembolic events', 'HAE attacks']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",,0.0321857,No thromboembolic events or cases of anaphylaxis were reported.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Allergy Section, Division of Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio. Electronic address: jonathan.bernstein@uc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma, and Dermatology Research Center, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Bygum', 'Affiliation': 'Hereditary Angioedema Centre Denmark, Department of Dermatology, and Allergy Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pennsylvania.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.015']
1544,32445735,"Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.
METHODS


This open-label, parallel-group, randomised controlled trial (DIADEM-I), done in primary care and community settings in Qatar, compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region. Participants were randomly allocated (1:1) either to the intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service. The intensive lifestyle intervention comprised a total diet replacement phase, in which participants were given formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support. Participants in the control group received usual diabetes care, which was based on clinical guidelines. The primary outcome was weight loss at 12 months after receiving the assigned intervention. Our analysis was based on the intention-to-treat principle. Key secondary outcomes included diabetes control and remission. The trial was registered with the ISRCTN registry, ISRCTN20754766, and ClinicalTrials.gov, NCT03225339.
FINDINGS


Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study. 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population. Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11·98 kg (95% CI 9·72 to 14·23) compared with 3·98 kg (2·78 to 5·18) in the control group (adjusted mean difference -6·08 kg [95% CI -8·37 to -3·79], p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12·03 [95% CI 5·17 to 28·03], p<0·0001). 33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12·07 [3·43 to 42·45], p<0·0001). Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia).
INTERPRETATION


Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.
FUNDING


Qatar National Research Fund.",2020,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"['147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population', 'Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study', '12·03', 'young individuals with early diabetes', 'individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region', 'early type 2 diabetes (DIADEM-I']","['intensive lifestyle intervention', 'usual diabetes care', 'intensive lifestyle intervention with usual medical care', 'intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service', 'formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support']","['weight loss and glycaemic outcomes', 'diabetes control and remission', 'unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia', 'weight loss', 'diabetes remission', 'normoglycaemia', 'weight loss and improved glycaemia', 'bodyweight and glycaemia', 'Diabetes remission', 'mean bodyweight']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0149881', 'cui_str': 'Orchitis and epididymitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",158.0,0.120849,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"[{'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Electronic address: staheri@me.com.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Chagoury', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Elhadad', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Salma Hayder', 'Initials': 'SH', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'El Khatib', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Rasha Abou', 'Initials': 'RA', 'LastName': 'Amona', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'El Nahas', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Suleiman', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alnaama', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Hamaq', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Charlson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Wells', 'Affiliation': 'University Department of Statistics and Data Science, Cornell University, Ithaca, New York, NY, USA.'}, {'ForeName': 'Samya', 'Initials': 'S', 'LastName': 'Al-Abdulla', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdul Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30117-0']
1545,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.
METHODS


We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.
FINDINGS


Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.
INTERPRETATION


Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.
FUNDING


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
1546,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR).
OBJECTIVE


We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial.
METHOD


The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL.
RESULTS


We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01).
CONCLUSIONS


Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004']
1547,32449530,Cranberries after pelvic floor surgery for urinary tract infection prophylaxis: A randomized controlled trial.,"AIMS


Urinary tract infection (UTI) is a common complication after pelvic floor surgery. Antibiotics as prophylaxis may reduce the prevalence of UTI's by 50%, but bacterial resistance may be a large disadvantage, necessitating the search for other possible prophylactic options. Recent research found a 50% reduction in the rate of UTI's with the use of cranberry capsules after elective gynecologic surgery, suggesting that cranberry capsules may serve as a good prophylaxis. The aim of this study was to assess whether perioperative cranberry prophylaxis reduces the risk of clinical overt UTI after elective pelvic floor surgery with indwelling catheter.
METHODS


We conducted a single-center randomized, double-blind, placebo-controlled trial. Women were given cranberry capsules twice daily or identical placebo for 6 weeks, starting the day before surgery. The main endpoint of the trial was the incidence of UTI within 6 weeks after surgery, defined as clinical diagnosis and treatment of UTI by the medical doctor. Analyses were performed with the intention to treat.
RESULTS


Two hundred ten participants were included, 105 in each arm. There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
CONCLUSIONS


This trial shows no beneficial effect of adequately dosed cranberry prophylaxis in women undergoing pelvic floor surgery, although such effect cannot be ruled out in settings with a higher prevalence of UTI's.",2020,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","['after elective pelvic floor surgery with indwelling catheter', 'Two hundred ten participants were included, 105 in each arm', 'women undergoing pelvic floor surgery']","['cranberry prophylaxis', 'perioperative cranberry prophylaxis', 'cranberry capsules twice daily or identical placebo', 'Cranberries after pelvic floor surgery', 'placebo']","['prevalence of UTI', 'clinical diagnosis and treatment of UTI by the medical doctor', 'risk of clinical overt UTI']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",210.0,0.623332,"There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated.
","[{'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Mooren', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'Liefers', 'Affiliation': 'Department of Hospital Pharmacy, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, The Netherlands.'}]",Neurourology and urodynamics,['10.1002/nau.24391']
1548,32446706,A role for the right dorsolateral prefrontal cortex in enhancing regulation of both craving and negative emotions in internet gaming disorder: A randomized trial.,"Reward-seeking and relief from negative emotions are two central motivational drives underlying addictions. Impaired executive control over craving and negative emotions contributes to compulsive addictive behaviors. Neuroimaging evidence has implicated the prefrontal cortex (PFC) in regulating craving or emotions. This study aims at examining whether anodal transcranial direct current stimulation (tDCS) over a specific region of the PFC would enhance both regulation processes. Thirty-three men with internet gaming disorder received active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC) one week apart in a randomized order. During each stimulation session, participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal. Subjective ratings of craving and negative emotions and skin conductance responses (SCRs) were recorded. For both craving and negative emotions, tDCS of the right dlPFC facilitated downregulation and upregulation: active relative to sham tDCS decreased ratings (ROC: 95% CI of difference -1.38 to -0.56, p < 0.001; ER: -1.65 to -0.70, p < 0.001) and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation. These findings provide the first experimental evidence confirming that tDCS of the right dlPFC enhances both craving- and negative-emotion-regulation. This suggests a promising approach for concurrently enhancing executive control over two central motivational drives underlying addictions.",2020,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","['Thirty-three men with internet gaming disorder received', 'internet gaming disorder']","['participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal', 'anodal transcranial direct current stimulation (tDCS', 'active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC']",['Subjective ratings of craving and negative emotions and skin conductance responses (SCRs'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",33.0,0.110968,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA; Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Mental Health Center, New Haven, CT, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Faculty of Education, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Department of Psychology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Yip', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jia-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China; Beijing Key Lab of Applied Experimental Psychology, School of Psychology, Beijing Normal University, Beijing, China. Electronic address: zhangjintao@bnu.edu.cn.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.04.003']
1549,32452846,Cardiogenic shock: role of invasive cardiology.,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI). Nevertheless, the mortality remains substantial, ranging between 40 and 50% after 30 days. The present review summarizes the current evidence regarding revascularization strategies, vascular access site and concomitant antiplatelet and antithrombotic treatment in infarct-related cardiogenic shock.
RECENT FINDINGS


On the basis of the SHOCK trial, early revascularization is the most relevant procedure to improve the outcome of patients with infarct-related cardiogenic shock. The majority of these patients present with multivessel coronary disease. The randomized CULPRIT-SHOCK trial showed that in the emergency setting, percutaneous coronary intervention (PCI) should be confined to the culprit lesion. Regarding vascular access site, no data derived from randomized controlled trials in cardiogenic shock are available. Emergency coronary artery bypass grafting (CABG) is nowadays rarely performed in cardiogenic shock with rates less than 5% but is still a treatment option if coronary anatomy is not amenable to PCI. Regarding antiplatelet treatment, a randomized trial testing the intravenous P2Y12 inhibitor cangrelor versus an oral P2Y12 inhibitor in infarct-related cardiogenic shock is currently being performed.
SUMMARY


Early revascularization is the cornerstone of treatment of infarct-related cardiogenic shock and should be confined to the culprit lesion in the emergency setting.",2020,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","['patients with cardiogenic shock following acute myocardial infarction (AMI', 'patients with infarct-related cardiogenic shock']","['percutaneous coronary intervention (PCI', 'Emergency coronary artery bypass grafting (CABG', 'intravenous P2Y12 inhibitor cangrelor']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1532296', 'cui_str': 'Emergency CABG'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}]",[],,0.1286,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}]",Current opinion in critical care,['10.1097/MCC.0000000000000738']
1550,32453275,TAS2R38 Haplotype Predicts 24-Hour Urinary Sodium Excretion in Patients With Heart Failure and Their Family Caregivers.,"BACKGROUND


Adherence to a low-sodium diet is essential to self-care of heart failure (HF). Genetic determinants of preference for high-sodium foods may impede adherence but have not been well-studied.
OBJECTIVE


Our purpose was to examine if TAS2R38 haplotype predicted salt taste sensitivity and dietary sodium intake among patients with HF.
METHOD


This pilot study used baseline data from a large interventional randomized control trial to support adherence to a low-sodium diet in patients with HF and their family caregivers. Participants were tested for salt taste sensitivity and provided a 24-hour urinary sodium sample and a blood sample for DNA analysis at baseline. Fungiform papillae were counted. χ Test and 1-way analysis of variance were used to compare haplotype groups. Linear regression was performed to examine predictors of salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density.
RESULTS


There were 42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker). Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
CONCLUSIONS


The results of our study partially supported our hypothesis that PAV homozygous haplotype predicts 24-hour urinary sodium excretion. With our small sample size, more research is needed. Understanding genetic influences on taste can lead to development of educational interventions tailored to patients with HF and their family caregivers to better support dietary adherence.",2020,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
","['patients with HF', '42 patients with HF and their family caregivers (age, 64.6 ± 13.4 years, 46.5% male, 97.7% white, and 90.7% nonsmoker', 'Patients With Heart Failure and Their Family Caregivers', 'patients with HF and their family caregivers']",['low-sodium diet'],"['salt taste sensitivity and 24-hour urinary sodium excretion, controlling for age, gender, ethnicity, smoking status, and fungiform papillae density', 'urinary sodium excretion', '24-hour urinary sodium excretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0012169', 'cui_str': 'Low sodium diet'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0226968', 'cui_str': 'Structure of fungiform papillae of tongue'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",42.0,0.028638,"Pronine-alanine-valine homozygous haplotype predicted lower urinary sodium excretion (b = -1780.59, t41 = -2.18, P = .036), but genotype was not a significant predictor of salt taste sensitivity.
","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Jennifer L Smith, PhD, RN Postdoctoral Fellow, College of Nursing, University of Kentucky, Lexington. Gia Mudd-Martin, PhD, MPH, RN, FAHA Associate Professor, College of Nursing, University of Kentucky, Lexington. Steven Estus, PhD Professor, Department of Physiology and Sanders-Brown Center on Aging, University of Kentucky, Lexington. Terry A. Lennie, PhD, RN, FAHA, FAAN Professor, Senior Associate Dean, College of Nursing, University of Kentucky, Lexington. Misook L. Chung, PhD, RN, FAHA, FAAN Professor, College of Nursing, University of Kentucky, Lexington.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Mudd-Martin', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Estus', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Lennie', 'Affiliation': ''}, {'ForeName': 'Misook L', 'Initials': 'ML', 'LastName': 'Chung', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000692']
1551,32573670,Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.,"Importance


Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.
Objective


To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery.
Design, Setting, and Participants


The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018.
Interventions


The dexamethasone group (n = 194) received 1 mg/kg of dexamethasone; the control group (n = 200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction.
Main Outcomes and Measures


The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization.
Results


All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, -0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P = .20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group.
Conclusions and Relevance


Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT02615262.",2020,"The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery.","['394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018', 'Infants Undergoing Cardiac Surgery', 'infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of', '394 patients randomized (median age, 6 months; 47.2% boys) completed the trial']","['dexamethasone', 'equivolume of 0.9% sodium chloride intravenously after anesthesia induction', 'Intraoperative Dexamethasone', 'placebo']","['major complications and mortality', 'individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization', 'Major Complications and Mortality', 'composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications', 'Infections']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",394.0,0.579415,"The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery.","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Lomivorotov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kornilov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Boboshko', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Shmyrev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Soynov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Voytov', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Polyanskih', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Strunin', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Caetano', 'Initials': 'C', 'LastName': 'Nigro Neto', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Gretel', 'Initials': 'G', 'LastName': 'Oliveira Nicolau', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Saurith Izquierdo', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Nogueira Nascimento', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Renjie', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Haibo', 'Affiliation': ""Shanghai Jiaotong University School of Medicine, Shanghai Children's Medical Center, Shanghai Shi, China.""}, {'ForeName': 'Vladlen', 'Initials': 'V', 'LastName': 'Bazylev', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Evdokimov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Shahrijar', 'Initials': 'S', 'LastName': 'Sulejmanov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Aleksei', 'Initials': 'A', 'LastName': 'Chernogrivov', 'Affiliation': 'Federal Centre of Cardiovascular Surgery, Penza, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}]",JAMA,['10.1001/jama.2020.8133']
1552,32569082,Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain?: a randomized controlled trial.,"Aerobic exercise is believed to be an effective chronic low back pain (CLBP) intervention, although its mechanisms remain largely untested. This study evaluated whether endogenous opioid (EO) mechanisms contributed to the analgesic effects of an aerobic exercise intervention for CLBP. Individuals with CLBP were randomized to a 6-week, 18-session aerobic exercise intervention (n = 38) or usual activity control (n = 44). Before and after the intervention, participants underwent separate laboratory sessions to assess responses to evoked heat pain after receiving saline placebo or i.v. naloxone (opioid antagonist) in double-blinded, crossover fashion. Chronic pain intensity and interference were assessed before and after the intervention. EO analgesia was indexed by naloxone-placebo condition differences in evoked pain responses (blockade effects). Relative to controls, exercise participants reported significantly greater pre-post intervention decreases in chronic pain intensity and interference (p's < .04) and larger reductions in placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total). At the group level, EO analgesia (MPQ-Total blockade effects) increased significantly pre-post intervention only among female exercisers (p = .03). Dose-response effects were suggested by a significant positive association in the exercise group between exercise intensity (based on meeting heart rate targets) and EO increases (MPQ-Present Pain Intensity; p = .04). Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009). Aerobic exercise training in the absence of other interventions appears effective for CLBP management. Aerobic exercise-related enhancements in endogenous pain inhibition, in part EO-related, likely contribute to these benefits.",2020,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,['Individuals with CLBP'],"['aerobic exercise intervention', 'naloxone-placebo', 'aerobic exercise training', '18-session aerobic exercise intervention', 'naloxone (opioid antagonist', 'Aerobic exercise', 'endogenous opioid (EO', 'Aerobic exercise training', 'usual activity control', 'saline placebo']","['chronic pain intensity and interference', 'evoked pain responses', 'Chronic pain intensity and interference', 'EO analgesia (MPQ-Total blockade effects', 'placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total', 'Enhanced EO analgesia (MPQ-Total', 'EO analgesia', 'average chronic pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",44.0,0.37122,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yung Hsuan', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': ""Qu'd"", 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Pain,['10.1097/j.pain.0000000000001969']
1553,32569395,Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis.,"BACKGROUND


Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.
OBJECTIVE


The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action.
METHODS


In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.
RESULTS


Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application.
CONCLUSIONS AND CLINICAL RELEVANCE


The novel preservative-free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.",2020,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","['allergic rhinitis', 'grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP']","['Budesonide', 'RA and placebo', 'solubilized low-dose budesonide nasal spray']","['TNSS and nasal airflow', 'Subjective symptom scores, nasal airflow and nasal secretion', 'nasal symptom score', 'nasal and respiratory symptoms']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0434773,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Unger-Manhart', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nakowitsch', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goessl', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Savli', 'Affiliation': 'Biostatistik & Consulting, Hartberg, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prieschl-Grassauer', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13691']
1554,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE


To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound.
STUDY DESIGN


We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine.
RESULTS


When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
CONCLUSION


The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014']
1555,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND


Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS.
OBJECTIVES


The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS.
PARTICIPANTS


Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention.
METHODS


The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test.
RESULTS


Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT).
CONCLUSION


A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256']
1556,32578685,Pharmacological treatment of female sexual dysfunction: a critical analysis of the placebo and nocebo effects.,,2020,,['female sexual dysfunction'],['placebo'],[],"[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.101458,,"[{'ForeName': 'Lucia Alves da Silva', 'Initials': 'LADS', 'LastName': 'Lara', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020ED5616']
1557,32574384,Long-term follow-up of human papillomavirus type replacement among young pregnant Finnish females before and after a community-randomised HPV vaccination trial with moderate coverage.,"Large scale human papillomavirus (HPV) vaccination against the most oncogenic high-risk human papillomavirus (HPV) types 16/18 is rapidly reducing their incidence. However, attempts at assessing if this leads to an increase of nonvaccine targeted HPV types have been hampered by several limitations, such as the inability to differentiate secular trends. We performed a population-based serological survey of unvaccinated young women over 12 years. The women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage. Serum samples were retrieved pre-CRT and post-CRT implementation. Seropositivity to 17 HPV types was assessed. HPV seroprevalence ratios (PR) comparing the postvaccination to prevaccination era were estimated by trial arm. This was also assessed among the sexual risk-taking core group, where type replacement may occur more rapidly. In total, 8022 serum samples from the population-based Finnish Maternity Cohort were retrieved. HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A  = 0.8, 95% CI 0.7-0.9). HPV6/11 and HPV73 were decreased after gender-neutral vaccination (PR 6/11A  = 0.8, 95% CI 0.7-0.9, PR 73A  = 0.7, 95% CI 0.6-0.9, respectively) and girls-only vaccination (PR 6/11B  = 0.8, 95% CI 0.7-0.9, PR 73B  = 0.9, 95% CI 0.8-1.0). HPV68 alone was increased but only after girls-only vaccination (PR 68B  = 1.3, 95% CI 1.0-1.7, PR core68B  = 2.8, 95% CI 1.2-6.3). A large-scale, long-term follow-up found no type replacement in the communities with the strongest reduction of vaccine HPV types. Limited evidence for an increase in HPV68 was restricted to girls-only vaccinated communities and may have been due to secular trends (ClinicalTrials.gov number: NCT00534638).",2020,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A   = 0.8, 95% CI 0.7-0.9).","['young pregnant Finnish females', '8022 serum samples from the population-based Finnish Maternity Cohort were retrieved in total', 'women were under 23-years-old, residents from 33 communities which participated in a community-randomised trial (CRT) with approximately 50% vaccination coverage', 'unvaccinated young women over 12 years']",['human papillomavirus (HPV) type replacement'],"['HPV6/11 and HPV73', 'HPV68 alone', 'HPV seroprevalence ratios (PR', 'HPV68']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0600367', 'cui_str': 'Seroprevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0730048,"HPV types 16/18 showed decreased seroprevalence among the unvaccinated in communities only after gender-neutral vaccination (PR 16/18A   = 0.8, 95% CI 0.7-0.9).","[{'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kann', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ville N', 'Initials': 'VN', 'LastName': 'Pimenoff', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Adhikari', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Research and Development, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heljä-Marja', 'Initials': 'HM', 'LastName': 'Surcel', 'Affiliation': 'Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Simopekka', 'Initials': 'S', 'LastName': 'Vänskä', 'Affiliation': 'Department of Infectious Disease Control and Vaccination, Inst. for Health & Welfare, Helsinki, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Faust', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.33169']
1558,32575482,Randomised Controlled Feasibility Study of the MyHealthAvatar-Diabetes Smartphone App for Reducing Prolonged Sitting Time in Type 2 Diabetes Mellitus.,"This study evaluated the feasibility and acceptability of a self-regulation smartphone app for reducing prolonged sitting in people with Type 2 diabetes mellitus (T2DM). This was a two-arm, randomised, controlled feasibility trial. The intervention group used the MyHealthAvatar-Diabetes smartphone app for 8 weeks. The app uses a number of behaviour change techniques aimed at reducing and breaking up sitting time. Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility. Interviews with participants explored intervention acceptability. Participants with T2DM were randomised to the control ( n  = 10) and intervention groups ( n  = 10). Recruitment and retention rates were 71% and 90%, respectively. The remaining participants provided 100% of data for the study measures. The MyHealthAvatar-Diabetes app was viewed as acceptable for reducing and breaking up sitting time. There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group. In conclusion, the findings indicate that it would be feasible to deliver and evaluate the efficacy of the MyHealthAvatar-Diabetes app for breaking up sitting time and improving health outcomes in a full trial.",2020,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","['Participants with T2DM', 'Type 2 Diabetes Mellitus', 'people with Type 2 diabetes mellitus (T2DM']","['MyHealthAvatar-Diabetes smartphone', 'self-regulation smartphone app', 'MyHealthAvatar-Diabetes Smartphone App']","['number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect', 'Recruitment and retention rates', 'Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility', 'health outcomes', 'Prolonged Sitting Time']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0445131', 'cui_str': 'Number of breaks'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0458148,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge UB8 3PH, UK.'}, {'ForeName': 'Lucie H', 'Initials': 'LH', 'LastName': 'Mugridge', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Department of Computer and Information Sciences, University of Strathclyde, Glasgow G1 1XH, UK.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute for Research in Applicable Computing, University of Bedfordshire, Luton LU1 3JU, UK.'}, {'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'Chater', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17124414']
1559,32579483,Protective effect of dexmedetomidine infusion combined with epidural blockade on postoperative complications after surgery: A prospective randomized controlled clinical trial.,"OBJECTIVES


This prospective, randomized, controlled study aimed to explore the efficacy of dexmedetomidine combined with epidural blockade on postoperative recovery of elderly patients after radical resection for colorectal cancer.
METHODS


Ninety-six elderly patients who underwent radical resection for colorectal cancer were randomly divided into the following four groups: dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine + epidural blockade), and control (0.9% saline). The Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates at 3 months were assessed.
RESULTS


Twelve hours after surgery, Ramsay scores were higher in the combined compared with the control and epidural blockade groups. Twenty-four hours after surgery, MMSE scores were higher in the combined compared with the other groups. The combined group showed the lowest VAS scores except at 48 hours. Time to first activity and length of hospital stay were significantly shorter in the combined compared with the other groups. There was no difference in total postoperative complication rates among the groups.
CONCLUSIONS


A combination of intraoperative dexmedetomidine infusion and epidural blockade could mitigate pain after surgery, improve cognitive dysfunction in early surgery, and facilitate recovery.",2020,"There was no difference in total postoperative complication rates among the groups.
","['elderly patients after radical resection for colorectal cancer', 'for colorectal cancer', 'Ninety-six elderly patients who underwent', 'after surgery']","['dexmedetomidine combined with epidural blockade', 'dexmedetomidine, epidural blockade (ropivacaine), combined (dexmedetomidine\u2009+\u2009epidural blockade), and control (0.9% saline', 'dexmedetomidine infusion combined with epidural blockade', 'radical resection', 'intraoperative dexmedetomidine infusion and epidural blockade']","['MMSE scores', 'lowest VAS scores', 'cognitive dysfunction', 'postoperative complications', 'total postoperative complication rates', 'Time to first activity and length of hospital stay', 'Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), and Ramsay scores at 48 hours, and time to first activity, length of hospital stay, and postoperative complication rates', 'Ramsay scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",96.0,0.113406,"There was no difference in total postoperative complication rates among the groups.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520930168']
1560,32578466,Additional Low-Voltage-Area Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the Randomized Controlled VOLCANO Trial.,"Background The efficacy of low-voltage-area (LVA) ablation has not been well determined. This study aimed to investigate the efficacy of LVA ablation in addition to pulmonary vein isolation on rhythm outcomes in patients with paroxysmal atrial fibrillation (AF). Methods and Results VOLCANO (Catheter Ablation Targeting Low-Voltage Areas After Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation. Of 398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A). The remaining 62 (15%) patients with LVAs were randomly allocated to undergo LVA ablation (group B, n=30) or not (group C, n=32) in a 1:1 fashion. Primary end point was 1-year AF-recurrence-free survival rate. No adverse events related to LVA ablation occurred. Procedural (124±40 versus 95±33 minutes,  P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes,  P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%,  P <0.0001; C, 53%,  P <0.0001). However, LVA ablation in addition to pulmonary vein isolation did not impact AF-recurrence-free survival rate (group B versus C,  P =0.67). Conclusions The presence of LVA was a strong predictor of AF recurrence after pulmonary vein isolation in patients with paroxysmal AF. However, LVA ablation had no beneficial impact on 1-year rhythm outcomes. Registration URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000023403.",2020,"Procedural (124±40 versus 95±33 minutes,  P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes,  P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%,  P <0.0001; C, 53%,  P <0.0001).","['Patients With Paroxysmal Atrial Fibrillation', 'The remaining 62 (15%) patients with LVAs', 'Paroxysmal Atrial Fibrillation Patients) trial included paroxysmal AF patients undergoing initial AF ablation', 'patients with paroxysmal atrial fibrillation (AF', '398 patients in whom a left atrial voltage map was obtained after pulmonary vein isolation, 336 (85%) had no LVA (group A', 'patients with paroxysmal AF']","['Catheter Ablation Targeting Low-Voltage Areas', 'Additional Low-Voltage-Area Ablation', 'low-voltage-area (LVA) ablation', 'pulmonary vein isolation', 'LVA ablation']","['1-year AF-recurrence-free survival rate', 'impact AF-recurrence-free survival rate', '1-year rhythm outcomes', 'fluoroscopic times', 'lower AF-recurrence-free survival rates', 'AF recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0452221,"Procedural (124±40 versus 95±33 minutes,  P =0.003) and fluoroscopic times (29±11 versus 24±8 minutes,  P =0.034) were longer in group B than group C. Patients with LVAs demonstrated lower AF-recurrence-free survival rates (88%) than those without LVA (B, 57%,  P <0.0001; C, 53%,  P <0.0001).","[{'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Asai', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Nanto', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsujimura', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Okuno', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Hata', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center Hyogo Japan.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015927']
1561,32574716,Stevens-Johnson Syndrome Secondary to Doxycycline Treatment in a Teenage Boy.,,2020,,[],['Doxycycline'],[],[],"[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]",[],,0.0152077,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Morgado-Carrasco', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'González Enseñat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vicente-Villa', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España. Electronic address: avicente@sjdhospitalbarcelona.org.'}]",Actas dermo-sifiliograficas,['10.1016/j.ad.2019.02.021']
1562,32575441,Modulation of Endothelial Glycocalyx and Microcirculation in Healthy Young Men during High-Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract. A Randomized Controlled Trial.,"The natural components of the pomegranate fruit may provide additional benefits for endothelial function and microcirculation. It was hypothesized that supplementation with pomegranate extract might improve glycocalyx properties and microcirculation during acute high-intensity sprint interval cycling exercise. Eighteen healthy and recreationally active male volunteers 22-28 years of age were recruited randomly to the experimental and control groups. The experimental group was supplemented with pomegranate extract 20 mL (720 mg phenolic compounds) for two weeks. At the beginning and end of the study, the participants completed a high-intensity sprint interval cycling-exercise protocol. The microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration were evaluated before and after the initial and repeated (after 2 weeks supplementation) exercise bouts. There were no significant differences in the microcirculation or glycocalyx over the course of the study ( p  < 0.05). The lactate concentration was significantly higher in both groups after the initial and repeated exercise bouts, and were significantly higher in the experimental group compared to the control group after the repeated bout: 13.2 (11.9-14.8) vs. 10.3 (9.3-12.7) mmol/L,  p  = 0.017. Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise. Although an unexplained rise in blood lactate concentration was observed.",2020,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"['Healthy Young Men during High', 'Eighteen healthy and recreationally active male volunteers 22-28 years of age']","['pomegranate extract 20 mL', 'Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract', 'high-intensity sprint interval cycling-exercise protocol', 'supplementation with pomegranate extract']","['microcirculation or glycocalyx', 'lactate concentration', 'glycocalyx properties and microcirculation', 'blood lactate concentration', 'microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration', 'microcirculation and glycocalyx']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",18.0,0.0780625,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"[{'ForeName': 'Zivile', 'Initials': 'Z', 'LastName': 'Pranskuniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Belousoviene', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Neringa', 'Initials': 'N', 'LastName': 'Baranauskiene', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Nerijus', 'Initials': 'N', 'LastName': 'Eimantas', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Vaitkaitiene', 'Affiliation': 'Department of Disaster Medicine and Health Research Institute, Lithuanian University of Health Sciences, Eiveniu g. 4, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Jurga', 'Initials': 'J', 'LastName': 'Bernatoniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Pranskunas', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}]",International journal of environmental research and public health,['10.3390/ijerph17124405']
1563,32576004,Application of an education model using the WeChat public platform in the standardized training of anesthesiology residents.,"BACKGROUND


Standardized training of clinical residents is an important way to train high-level clinicians and is an important step to ensure quality clinical work. WeChat facilitates efficient information dissemination and feedback, convenient communication. In the new media era, the influence of WeChat has inspired changes in educational methods, to explore the role of an education model using the WeChat public platform in the standardized training of anesthesiology residents.
METHODS


A total of 40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017 were selected as subjects and randomly divided into 2 groups: traditional group (n=20) and WeChat group (n=20). In the WeChat group, in addition to the traditional clinical teaching model (lectures), the residents also received push information from the WeChat public platform for anesthesia education. The residents in the traditional group did not receive the push information and only received traditional clinical teaching. Three months later, assessment scores of and teaching quality in the 2 groups were evaluated. Teaching quality was evaluated using peer assessment and self-assessment questionnaires.
RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05). The questionnaire results indicated that the degree of satisfaction of the residents and teachers in the WeChat group was significantly higher than that in the traditional group (P<0.05). The theoretical knowledge scores, operational skill scores and overall scores in the WeChat group were significantly higher than those in the traditional group (P<0.05).
CONCLUSIONS


Applying an education model based on the WeChat public platform in standardized training of anesthesiology residents can significantly improve teaching efficacy and satisfaction, enhance comprehensive assessment results, and improve teaching quality.",2020,"RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","['40 anesthesiology residents undergoing standardized training in our department from January 2016 to August 2017', 'anesthesiology residents']","['push information and only received traditional clinical teaching', 'WeChat']","['teaching quality', 'theoretical knowledge scores, operational skill scores and overall scores', 'Teaching quality', 'teaching efficacy and satisfaction', 'assessment scores of and teaching quality', 'theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English']","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",,0.0113754,"RESULTS


Residents in the WeChat group performed significantly better on assessments than those in traditional group regarding theoretical knowledge of anesthesiology, understanding mechanisms, operation ability, current knowledge, case analyses and use of professional English (P<0.05).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. lijinbaoshanghai@163.com.'}]",Annals of palliative medicine,['10.21037/apm-19-390']
1564,32579567,School-based intervention to address self-regulation and executive functioning in children attending primary schools in remote Australian Aboriginal communities.,"Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.",2020,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","['Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study', 'children attending primary schools in remote Australian Aboriginal communities', ""children's executive functioning and self-regulation skills"", 'Teachers from 26 primary school classrooms across eight Fitzroy Valley schools', 'remote Australian Aboriginal community schools']","['alcohol or early life trauma (ELT', 'School-based intervention to address self-regulation and executive functioning', '8-week Alert Program® intervention']","[""parent and teacher ratings of children's behavioral, emotional, and cognitive regulation"", 'executive functioning and behavior', ""children's executive functioning skills or behavior"", 'physical and mental health, educational success, and employment']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",271.0,0.0226753,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","[{'ForeName': 'Bree', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael Olson', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Symons', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'Child and Family Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Jirikowic', 'Affiliation': 'Division of Occupational Therapy, Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Watkins', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boulton', 'Affiliation': 'The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Edie', 'Initials': 'E', 'LastName': 'Wright', 'Affiliation': 'Western Australian Department of Education Kimberley Education Region, Broome, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Carter', 'Affiliation': 'Nindilingarri Cultural Health Services, Fitzroy Crossing, Western Australia, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fitzpatrick', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0234895']
1565,32579779,Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery.,"BACKGROUND


The optimum cardiac surgical pain management has known to maintain hemodynamic stability and, reduces respiratory and cardiovascular complications. Postoperative parasternal intercostal block has shown to reduce postoperative analgesic consumption after cardiac surgery. Therefore, this study sought to investigate the effectiveness of the preoperative ultrasound guided parasternal block in reducing postoperative pain after cardiac surgery.
METHODS


This was a randomized, prospective, interventional, single blind study comprised of 90 adult patients scheduled for cardiac surgery involving sternotomy. Preoperatively and postoperatively, 0.25% bupivacaine administered in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under ultrasound guidance and direct vision, respectively. Postoperative pain was rated according to visual analogue scale. Secondary outcomes included intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation.
MAIN RESULTS


There was no significant differences in visual analogue score visual analogue score at all time points till 24 hours postoperatively. Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72; P = .0001). Furthermore, there were no significant difference in total fentanyl requirement (7.20 ± 2.66 vs 8.37 ± 3.13; P = .06) and tramadol requirement (0.02 ± 0.15 vs 0.07 ± 0.26; P = .28) within first 24 hours. However, time to extubation was significantly higher in the preoperative group (P = .02).
CONCLUSIONS


Preoperative and postoperative parasternal intercostal block provide comparable pain relief during the postoperative period.",2020,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"['90 adult patients scheduled for cardiac surgery involving sternotomy', 'cardiac surgery']","['preoperative ultrasound guided parasternal block', 'bupivacaine', 'preincisional and postincisional parasternal intercostal block']","['visual analogue score visual analogue score', 'Intraoperative fentanyl requirements', 'total fentanyl requirement', 'pain relief', 'time to extubation', 'postoperative pain', 'postoperative analgesic consumption', 'intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation', 'Postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",90.0,0.116657,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"[{'ForeName': 'Sri Rama Ananta Nagabhushanam', 'Initials': 'SRAN', 'LastName': 'Padala', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashok Shankar', 'Initials': 'AS', 'LastName': 'Badhe', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Satyen', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14651']
1566,32579813,Hydroxyurea Dose Escalation for Sickle Cell Anemia in Sub-Saharan Africa.,"BACKGROUND


Hydroxyurea has proven safety, feasibility, and efficacy in children with sickle cell anemia in sub-Saharan Africa, with studies showing a reduced incidence of vaso-occlusive events and reduced mortality. Dosing standards remain undetermined, however, and whether escalation to the maximum tolerated dose confers clinical benefits that outweigh treatment-related toxic effects is unknown.
METHODS


In a randomized, double-blind trial, we compared hydroxyurea at a fixed dose (approximately 20 mg per kilogram of body weight per day) with dose escalation (approximately 30 mg per kilogram per day). The primary outcome was a hemoglobin level of 9.0 g or more per deciliter or a fetal hemoglobin level of 20% or more after 24 months. Secondary outcomes included the incidences of malaria, vaso-occlusive crises, and serious adverse events.
RESULTS


Children received hydroxyurea at a fixed dose (94 children; mean [±SD] age, 4.6±1.0 years) or with dose escalation (93 children; mean age, 4.8±0.9 years); the mean doses were 19.2±1.8 mg per kilogram per day and 29.5±3.6 mg per kilogram per day, respectively. The data and safety monitoring board halted the trial when the numbers of clinical events were significantly lower among children receiving escalated dosing than among those receiving a fixed dose. At trial closure, 86% of the children in the dose-escalation group had reached the primary-outcome thresholds, as compared with 37% of the children in the fixed-dose group (P<0.001). Children in the dose-escalation group had fewer sickle cell-related adverse events (incidence rate ratio, 0.43; 95% confidence interval [CI], 0.34 to 0.54), vaso-occlusive pain crises (incidence rate ratio, 0.43; 95% CI, 0.34 to 0.56), cases of acute chest syndrome or pneumonia (incidence rate ratio, 0.27; 95% CI, 0.11 to 0.56), transfusions (incidence rate ratio, 0.30; 95% CI, 0.20 to 0.43), and hospitalizations (incidence rate ratio, 0.21; 95% CI, 0.13 to 0.34). Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia.
CONCLUSIONS


Among children with sickle cell anemia in sub-Saharan Africa, hydroxyurea with dose escalation had superior clinical efficacy to that of fixed-dose hydroxyurea, with equivalent safety. (Funded by the Doris Duke Charitable Foundation and the Cincinnati Children's Research Foundation; NOHARM MTD ClinicalTrials.gov number, NCT03128515.).",2020,"Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia.
","['children with sickle cell anemia in sub-Saharan Africa', 'Sickle Cell Anemia in Sub-Saharan Africa']","['Hydroxyurea Dose Escalation', 'hydroxyurea', 'Hydroxyurea']","['vaso-occlusive pain crises', 'incidences of malaria, vaso-occlusive crises, and serious adverse events', 'acute chest syndrome or pneumonia', 'Laboratory-confirmed dose-limiting toxic effects', 'hemoglobin level of 9.0 g or more per deciliter or a fetal hemoglobin level', 'severe neutropenia or thrombocytopenia', 'sickle cell-related adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0200695', 'cui_str': 'Fetal hemoglobin determination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}]",,0.524197,"Laboratory-confirmed dose-limiting toxic effects were similar in the two groups, and there were no cases of severe neutropenia or thrombocytopenia.
","[{'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Teresa S', 'Initials': 'TS', 'LastName': 'Latham', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hume', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Nabaggala', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Kasirye', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Ndugwa', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""From the Ryan White Center for Pediatric Infectious Diseases and Global Health, Department of Pediatrics, Indiana University, Indianapolis (C.C.J.); the Department of Pediatrics and Child Health, Makerere University (R.O.O., H.A.H., C.N., P.K., C.M.N.), Global Health Uganda (R.O.O., C.N.), and Mulago Hospital (P.K.) - all in Kampala, Uganda; the Division of Hematology, Department of Pediatrics (T.S.L., A.L., R.E.W.), and the Global Health Center (R.E.W.), Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine (A.L., R.E.W.) - all in Cincinnati; and the Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montreal (H.A.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000146']
1567,32579811,Effects of Allopurinol on the Progression of Chronic Kidney Disease.,"BACKGROUND


Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known.
METHODS


In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2  of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.
RESULTS


Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m 2  per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m 2  per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group.
CONCLUSIONS


In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).",2020,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and","['patients with chronic kidney disease who are at risk for progression is not known', 'patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with', 'The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter', 'Enrollment was stopped because of slow recruitment after 369 of 620 intended patients', 'randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2  of body-surface area in the preceding year to receive']","['placebo', 'allopurinol', 'Allopurinol']","['Chronic Kidney Disease Epidemiology Collaboration creatinine equation', 'glomerular filtration rate (eGFR', 'change in eGFR', 'Progression of Chronic Kidney Disease', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4552444', 'cui_str': 'Estimated glomerular filtration rate decreased'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",620.0,0.744268,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2  per year [95% confidence interval {CI}, -4.11 to -2.55] and","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Anushree', 'Initials': 'A', 'LastName': 'Tiku', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Brown', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Douglas', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Faull', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Harris', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Graham R D', 'Initials': 'GRD', 'LastName': 'Jones', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Gopala K', 'Initials': 'GK', 'LastName': 'Rangan', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915833']
1568,32579812,Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,"BACKGROUND


The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial.
METHODS


We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review.
RESULTS


The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors.
CONCLUSIONS


Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.).",2020,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).",['pediatric resident physicians during their intensive care unit (ICU) rotations'],[],"['number of serious errors unitwide', 'errors', 'serious errors', 'serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376531', 'cui_str': 'Errors, Medical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}]",,0.0840156,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900669']
1569,32462307,Comorbid anxiety and irritability symptoms and their association with cognitive functioning in children with ADHD.,"Anxiety and irritability symptoms frequently co-occur in children with Attention-Deficit/Hyperactivity Disorder (ADHD). This study aims to investigate whether irritability and anxiety are uniquely associated with performance on measures of cognitive functioning in children with ADHD and whether these associations hold when accounting for confounding variables. Baseline data was used from a randomised controlled trial of cognitive behavioural therapy for anxiety in children with ADHD (N = 219, 8-13 years). Anxiety was assessed using the child- and parent-reported Spence Children's Anxiety Scale, while irritability was assessed using the parent-reported Affective Reactivity Index. Children completed the National Institutes of Health Toolbox - Cognition Battery. Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03). These associations did not survive correction for multiple comparisons. There was little evidence of an association between anxiety or irritability symptoms and cognitive functioning. Frequent co-occurrence of anxiety and irritability suggests clinicians working with children with ADHD should assess co-morbid symptom profiles to inform the provision of optimum care.",2020,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","['children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD']",['cognitive behavioural therapy'],"['Anxiety and irritability symptoms', 'Comorbid anxiety and irritability symptoms', ""Spence Children's Anxiety Scale, while irritability"", 'Anxiety', 'anxiety or irritability symptoms and cognitive functioning', 'irritability and anxiety', 'List Sort Working Memory Test', 'Higher symptoms of anxiety', 'symptoms of irritability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0542262,"Higher symptoms of anxiety were uniquely associated with performance on the Dimensional Card Change Sort Test (β = -2.75, confidence interval (CI) [-4.97, -.52], p = .02) and the List Sort Working Memory Test (β = -2.57, CI [-4.43, -.70], p = .01), while higher symptoms of irritability were negatively associated with Picture Vocabulary Test (β = -2.00, CI [-3.83, -.16], p = .03).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia. nicolacread@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University Geelong, Victoria, Australia.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00658-z']
1570,32444553,Effect of a Multimodal Lifestyle Intervention on Sleep and Cognitive Function in Older Adults with Probable Mild Cognitive Impairment and Poor Sleep: A Randomized Clinical Trial.,"BACKGROUND


Poor sleep is common among older adults with mild cognitive impairment (MCI) and may contribute to further cognitive decline. Whether multimodal lifestyle intervention that combines bright light therapy (BLT), physical activity (PA), and good sleep hygiene can improve sleep in older adults with MCI and poor sleep is unknown.
OBJECTIVE


To assess the effect of a multimodal lifestyle intervention on sleep in older adults with probable MCI and poor sleep.
METHODS


This was a 24-week proof-of-concept randomized trial of 96 community-dwelling older adults aged 65-85 years with probable MCI (<26/30 on the Montreal Cognitive Assessment) and poor sleep (>5 on the Pittsburgh Sleep Quality Index [PSQI]). Participants were allocated to either a multimodal lifestyle intervention (INT); or 2) education + attentional control (CON). INT participants received four once-weekly general sleep hygiene education classes, followed by 20-weeks of: 1) individually-timed BLT; and 2) individually-tailored PA promotion. Our primary outcome was sleep efficiency measured using the MotionWatch8© (MW8). Secondary outcomes were MW8-measured sleep duration, fragmentation index, wake-after-sleep-onset, latency, and PSQI-measured subjective sleep quality.
RESULTS


There were no significant between-group differences in MW8 measured sleep efficiency at 24-weeks (estimated mean difference [INT -CON]: 1.18%; 95% CI [-0.99, 3.34]), or any other objective-estimate of sleep. However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
CONCLUSION


Among individuals with probable MCI and poor sleep, a multimodal lifestyle intervention improves subjective sleep quality, but not objectively estimated sleep.",2020,"However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
","['older adults with probable MCI and poor sleep', 'individuals with probable MCI and poor sleep', 'older adults with MCI and poor sleep', 'Older Adults with Probable Mild Cognitive Impairment and Poor Sleep', '96 community-dwelling older adults aged 65-85 years with probable MCI (<26/30 on the Montreal Cognitive Assessment) and poor sleep (>5 on the Pittsburgh Sleep Quality Index [PSQI', 'older adults with mild cognitive impairment (MCI']","['multimodal lifestyle intervention that combines bright light therapy (BLT), physical activity (PA), and good sleep hygiene', 'multimodal lifestyle intervention (INT); or 2) education\u200a+\u200aattentional control (CON', 'multimodal lifestyle intervention', 'Multimodal Lifestyle Intervention', 'weekly general sleep hygiene education classes, followed by 20-weeks of: 1) individually-timed BLT; and 2) individually-tailored PA promotion']","['objective-estimate of sleep', 'MW8-measured sleep duration, fragmentation index, wake-after-sleep-onset, latency, and PSQI-measured subjective sleep quality', 'MW8 measured sleep efficiency', 'Sleep and Cognitive Function', 'sleep efficiency measured using the MotionWatch8© (MW8', 'subjective sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",96.0,0.0385551,"However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Faculty of Management, University of British Columbia-Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Patrick C Y', 'Initials': 'PCY', 'LastName': 'Chan', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Arthritis Research Canada, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Wyrough', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Bennett', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Backhouse', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200383']
1571,32444570,Effects of robot-assisted gait training alongside conventional therapy on the development of walking in children with cerebral palsy.,"PURPOSE


To investigate the effects of robot-assisted gait training (RAGT) alongside conventional therapy on the standing and walking abilities of children with cerebral palsy (CP).
METHODS


The study sample consisted of children (aged 4-18 years) with CP whose gross motor function classification system (GMFCS) was at levels I-V. In total, 75 children with CP were evaluated and 38 patients completed the study. Patients were divided into two groups as GMFCS levels I-III (Group 1) and levels IV-V (Group 2). RAGT (30 min/session) and conventional physiotherapy (30 min/session) were applied together in the treatment. The treatment duration was 60 min per session, 3 or 4 sessions per week, for a total of 30 sessions over 8-10 weeks. 10-meter walk test (10MWT), 6-min walk test (6MinWT), gross motor functional measurement 66 (GMFM66) -D, and -E tests were performed.
RESULTS


We showed that in both groups of CP patients (mild-moderate and severe), meaningful improvements were seen in the standing (D) and walking (E) sections of GMFM-66 after treatment. When we compared the post-treatment changes in 10-m walk test, 6-min walk test, GMFM66-D, and -E between Groups 1 and 2, we noted that the improvements were statistically significant in favor of Group 1 (p< 0.01).
CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).",2020,"CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).","['children with cerebral palsy (CP', 'children (aged 4-18 years) with CP whose gross motor function classification system (GMFCS) was at levels I-V', 'children with cerebral palsy', '75 children with CP were evaluated and 38 patients completed the study']","['robot-assisted gait training (RAGT) alongside conventional therapy', 'conventional physiotherapy', 'RAGT', 'robot-assisted gait training alongside conventional therapy']","['10-m walk test, 6-min walk test, GMFM66-D, and -E', 'standing and walking abilities', '10-meter walk test (10MWT), 6-min walk test (6MinWT), gross motor functional measurement 66 (GMFM66) -D, and -E tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1275991', 'cui_str': 'E test'}]",75.0,0.0159701,"CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Sucuoglu', 'Affiliation': ''}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-180541']
1572,32444573,"Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT).","PURPOSE


To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.
METHODS


Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure-88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5-week follow-up.
RESULTS


The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were -0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable.
CONCLUSIONS


RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.",2020,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","['children with cerebral palsy (PeLoGAIT', '16 children with a mean age of 11.3 years (6.0-15.3 years', 'ambulatory children with spastic cerebral palsy', 'Children']","['outpatient robot-assisted gait training (RAGT', 'robot-assisted gait training', 'RAGT']","['Dimension D (GMFM D), and timed walking tests', 'walking abilities', 'GMFM E median (IQR) change scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.0332735,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Ammann-Reiffer', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Functioning and Rehabilitation, CAPHRI, Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Meyer-Heim', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-190614']
1573,32445277,Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.,"BACKGROUND


Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) seriously impairs health-related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with CRSwNP.
METHODS


Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). Baseline characteristics predictive of change in SF-36 and SF-6D scores were assessed.
RESULTS


Mean baseline SF-36v2 scores were below population norms. At EODB, mean improvement was greater for all SF-36v2 domain and component scores with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); physical and mental component score improvements within the EDS-FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline.
CONCLUSION


In this pooled analysis of 2 large pivotal EDS-FLU trials, health domain and health utilities improvements were significantly greater with EDS-FLU than EDS-PBO and were comparable to population norms.",2020,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).",['patients with CRSwNP'],"['nasal polyps (CRSwNP/CRSsNP', 'EDS-FLU vs placebo (EDS-PBO', 'fluticasone (EDS-FLU', 'fluticasone']","['SF-6D utility scores', 'quality of life and health status', 'At EOOL, SF-36v2 and SF-6D mean scores', 'SF-36 and SF-6D scores', 'Mean baseline SF-36v2 scores', 'physical and mental component score improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.118395,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).","[{'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Soler', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'OptiNose US, Inc., Yardley, PA.'}, {'ForeName': 'Fulton F', 'Initials': 'FF', 'LastName': 'Velez', 'Affiliation': 'Covance Market Access Services Inc, Gaithersburg, MD.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Schlosser', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}]",International forum of allergy & rhinology,['10.1002/alr.22573']
1574,32445738,"Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial.","BACKGROUND


People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec.
METHODS


In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete.
FINDINGS


Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events).
INTERPRETATION


A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial.
FUNDING


Novo Nordisk.",2020,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","['People with type 1 diabetes who use', '24 participants who completed both study phases', '43 patients for eligibility, of whom 31', 'LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII', 'physically active adults with type 1 diabetes (FIT Untethered', 'adults with type 1 diabetes who exercise regularly']","['Flexible insulin therapy', 'injected insulin degludec and CSII (with pump removal during exercise', 'usual CSII regimen (n=14) or hybrid CSII regimen', 'continuous subcutaneous insulin infusion (CSII, or insulin pump therapy', 'insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise']","['longer time in blood glucose range', 'higher time in blood glucose range', 'time spent in hypoglycaemia, nor the number of hypoglycaemic events', 'efficacy and safety', '1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose', 'time spent in hyperglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",43.0,0.0906429,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","[{'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada. Electronic address: ronnie.aronson@lmc.ca.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGaugh', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30114-5']
1575,32449396,Taking Care of Yourself and Your Risk for Breast Cancer (CUIDARSE): A Randomized Controlled Trial of a Health Communication Intervention for Latinas.,"Latinas in the United States are more likely to be diagnosed with late-stage breast cancer (BC) compared to non-Latinas. Literacy-appropriate and culturally sensitive cancer communication interventions can help address existing racial/ethnic BC disparities. We formatively developed a new BC prevention brochure for Spanish-speaking Latinas (≥35 years). Eligible women ( n  = 240) from a large public hospital in California were randomly assigned to one of three study arms: Group 1 received the new brochure, Group 2 included a community health worker (CHW) who delivered the new brochure's content, and a control group received a standard educational brochure. Participants completed three surveys (baseline, postintervention, 3-month follow-up) with a 100% completion rate for the first two surveys and 80.4% completion after 3 months. We assessed the difference in outcomes for BC risk knowledge, perceived BC susceptibility, and BC information self-efficacy between groups. Participant mean age was 52.3 years, and 82.1% reported low English proficiency. Mean knowledge scores increased and perceived BC susceptibility improved for all groups ( p  ≤ .05), yet treatment effects were not significant between groups for these outcomes. BC information self-efficacy also increased from baseline to postintervention for all groups to >80%. After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models. A CHW-delivered intervention may be more effective in improving BC information self-efficacy among Latinas compared to print material alone. More research is needed to examine the efficacy of CHW-delivered interventions.",2020,"After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models.","['Spanish-speaking Latinas (≥35 years', 'Eligible women ( n  = 240) from a large public hospital in California', 'Breast Cancer (CUIDARSE', 'Latinas', 'Participant mean age was 52.3 years, and 82.1% reported low English proficiency']","['Health Communication Intervention', 'Literacy-appropriate and culturally sensitive cancer communication interventions', ""new brochure, Group 2 included a community health worker (CHW) who delivered the new brochure's content, and a control group received a standard educational brochure""]","['BC susceptibility', 'BC risk knowledge, perceived BC susceptibility, and BC information self-efficacy', 'Mean knowledge scores', 'BC information self-efficacy']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C1512347', 'cui_str': 'Health Communication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.069156,"After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models.","[{'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Payán', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Maggard-Gibbons', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Flórez', 'Affiliation': 'City University of New York, New York City, NY, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mejía', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Hemmelgarn', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kanouse', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Kahn', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Golinelli', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Diaz Fuentes', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Sydne J', 'Initials': 'SJ', 'LastName': 'Newberry', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Marielena', 'Initials': 'M', 'LastName': 'Lara', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120920529']
1576,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND


Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown.
METHODS


In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36).
RESULTS


A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
CONCLUSIONS


In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883']
1577,32447296,"CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study.","BackgroundConcurrent chemoradiotherapy is the standard of care for locally advanced cervical cancer. Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
PRIMARY OBJECTIVE


The CALLA trial is designed to determine the efficacy and safety of the programmed cell death-ligand 1 blocking antibody, durvalumab, with and following concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in women with locally advanced cervical cancer.
STUDY HYPOTHESIS


Durvalumab concurrent with and following concurrent chemoradiotherapy will improve progression-free survival in patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA cervical cancer compared with concurrent chemoradiotherapy alone.
TRIAL DESIGN


CALLA is a phase III, randomized, multicenter, international, double-blind, placebo-controlled study. Patients will be randomized 1:1 to receive either durvalumab (1500 mg intravenously (IV)) or placebo every 4 weeks for 24 cycles. All patients will receive external beam radiotherapy with cisplatin (40 mg/m 2 ) IV or carboplatin (area under the curve 2) IV once a week for 5 weeks, followed by image-guided brachytherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study will enroll immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage. Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer.
PRIMARY ENDPOINT


The primary endpoint is progression-free survival (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors v1.1, histopathological confirmation of local tumor progression or death).
SAMPLE SIZE


Approximately 714 patients will be randomized 1:1 to receive either durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Patient enrollment is continuing globally with an estimated completion date of April 2024.
TRIAL REGISTRATION


NCT03830866.",2020,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","['Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer', 'naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage', 'locally advanced cervical cancer', 'Approximately 714 patients', 'women with locally advanced cervical cancer', 'patients with International Federation of Gynecology and Obstetrics']","['durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy', 'chemoradiotherapy versus concurrent chemoradiotherapy alone', 'placebo', 'chemoradiotherapy', 'Concurrent chemoradiotherapy', 'durvalumab', 'immunotherapy', 'external beam radiotherapy with cisplatin (40\u2009mg/m 2 ) IV or carboplatin', 'CALLA', 'concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone']","['progression-free survival', 'histopathological confirmation of local tumor progression or death', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0279672', 'cui_str': 'Adenocarcinoma of cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0331463', 'cui_str': 'Calla'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.614757,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'GYN Cancers, Rebecca and John Moores Cancer Center, La Jolla, California, USA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Nunes', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Marcovitz', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Josephs Hospital and Medical Center, Phoenix, Arizona, USA bradley.monk@usoncology.com.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001135']
1578,32452590,The effects of indoor ambient temperature at work on physiological adaptation in night shift nurses.,"AIM


To examine the effects of indoor ambient temperature on thermal comfort, night work tolerance (fatigue, sleepiness and night adaptation) and urinary melatonin in night shift nurses.
BACKGROUND


Night shift induces physical stress and mental stress. Night shift work and ambient temperature are associated with work performance. The working environment must be improved for successful night shift working. However, the effects of indoor ambient temperature on night shift nurses are unclear.
METHODS


In this crossover study, 20 participants were divided into two groups of 10 and were assigned to work in one of two thermo-controlled environments (23°C vs. 26°C) during two consecutive night shifts. Thermal and humidity sensation vote, night work tolerance, body temperature and urinary melatonin were assessed.
RESULTS


There were significant differences between the two groups in thermal sensation and body temperature. There were no significant differences in humidity sensation vote or night work tolerance. Urinary melatonin levels decreased significantly during the second 23°C night shift.
CONCLUSION


A temperature of 23°C may exert a positive effect on night shift adaptation.
IMPLICATIONS FOR NURSING MANAGEMENT


Nurses and nursing managers should assess thermal comfort during night shifts, and improved thermal comfort level should be provided to nurses.",2020,There were significant differences between the two groups in thermal sensation vote and body temperature.,"['nursing management Nurses and nursing managers', 'Night Shift Nurses', '20 participants']","['indoor ambient temperature', 'Indoor Ambient Temperature']","['Urinary melatonin levels', 'Thermal and humidity sensation vote, night work tolerance, body temperature, and urinary melatonin', 'thermal comfort, night work tolerance (fatigue, sleepiness, and night adaptation', 'humidity sensation vote or night work tolerance', 'thermal sensation vote and body temperature']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042978', 'cui_str': 'Voting'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",20.0,0.0098016,There were significant differences between the two groups in thermal sensation vote and body temperature.,"[{'ForeName': 'Jeong Hun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Yeoungsuk', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Research Institute of Nursing Science, Kyungpook National University College of Nursing, Daegu, Korea.'}]",Journal of nursing management,['10.1111/jonm.13052']
1579,32450367,Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.,"Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.",2020,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","['150 participants (76.1% female, 55.8% white, BMI\u202f=\u202f38.8\u202f±\u202f4.8\u202fkg/m 2 ']","['intensive behavioral therapy (IBT', 'IBT alone, IBT with liraglutide 3.0\u202fmg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'liraglutide']","['Early weight loss', 'weight loss', 'total weight loss', 'visit attendance, dietary self-monitoring, medication, and meal-replacement adherence', 'self-monitoring and medication adherence', 'medication adherence']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",150.0,0.0213041,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, USA.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103639']
1580,32450928,A randomized clinical trial to assess the efficacy of trial-based cognitive therapy compared to prolonged exposure for post-traumatic stress disorder: preliminary findings.,"BACKGROUND.


Post-traumatic stress disorder (PTSD) is a prevalent mental health condition that is often associated with psychiatric comorbidities and changes in quality of life. Prolonged exposure therapy (PE) is considered the gold standard psychological treatment for PTSD, but treatment resistance and relapse rates are high. Trial-based cognitive therapy (TBCT) is an effective treatment for depression and social anxiety disorder, and its structure seems particularly promising for PTSD. Therefore, we evaluated the efficacy of TBCT compared to PE in patients with PTSD.
METHODS.


Ninety-five patients (77.6% females) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, criteria for PTSD were randomly assigned to receive either TBCT (n = 44) or PE (n = 51). Patients were evaluated before and after treatment, and at follow-up 3 months after treatment. The primary outcome was improvement in PTSD symptoms as assessed by the Davidson Trauma Scale (DTS). Secondary outcomes were depression, anxiety, and dysfunctional attitudes assessed by the Beck Depression/Anxiety Inventories and Dysfunctional Attitudes Scale, as well as the dropout rate.
RESULTS.


A significant reduction in DTS scores was observed in both arms, but no significant difference between treatments. Regarding the secondary outcomes, we found significant differences in depressive symptoms in favor of TBCT, and the dropout rate was lower in the TBCT group than the PE group.
CONCLUSION.


Our preliminary results suggest that TBCT may be an effective alternative for treating PTSD. Further research is needed to better understand its role and the mechanisms of change in the treatment of this disorder.",2020,,['post-traumatic stress disorder'],['trial-based cognitive therapy (TBCT'],[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0479708,,"[{'ForeName': 'Érica Panzani', 'Initials': 'ÉP', 'LastName': 'Duran', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Corchs', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianna', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Cabral', 'Initials': 'ÁC', 'LastName': 'Araújo', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Del Real', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'De Vitto Francez', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Godói', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Silveira', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Matsumoto', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cristiane Maluhy', 'Initials': 'CM', 'LastName': 'Gebara', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tito Paes', 'Initials': 'TP', 'LastName': 'de Barros Neto', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Chilvarquer', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana Lima', 'Initials': 'LL', 'LastName': 'de Siqueira', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Bernik', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Francisco Lotufo', 'Initials': 'FL', 'LastName': 'Neto', 'Affiliation': 'Postgraduate Anxiety Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}]",CNS spectrums,['10.1017/S1092852920001455']
1581,32452208,"The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.","BACKGROUND


Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR.
HYPOTHESIS


Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at  P  < .10. The Cohen  d  was calculated to determine the effect size.
RESULTS


HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( P  < .05;  d  = 2.93). The primary outcome measure was knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque by 29% compared with the placebo group ( P  = .05;  d  = 0.80). Matrix metalloproteinase-3 (MMP3), which was used as an indirect biomarker of cartilage degradation, was 36% lower in the HGH group ( P  = .05;  d  = -1.34). HGH did not appear to be associated with changes in muscle volume or patient-reported outcome scores.
CONCLUSION


HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted.
REGISTRATION


NCT02420353 ( ClinicalTrials.gov identifier).",2020,Matrix metalloproteinase-3,"['patients undergoing ACLR', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'Anterior cruciate ligament (ACL) tears are common knee injuries', '19 male patients (aged 18-35 years) scheduled to undergo ACLR', 'patients undergoing ACLR are warranted']","['extensive rehabilitation after ACL reconstruction (ACLR', 'Recombinant Human Growth Hormone', 'Placebo', 'Human growth hormone (HGH', 'Matrix metalloproteinase-3', 'placebo or HGH', 'HGH', 'placebo']","['quadriceps strength and reduced MMP3 levels', 'knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque', 'adverse events', 'Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers', 'circulating insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}]","[{'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",19.0,0.277985,Matrix metalloproteinase-3,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Elizabeth R Sibilsky', 'Initials': 'ERS', 'LastName': 'Enselman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Olszewski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Gumucio', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edon', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Konnaris', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Carpenter', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Awan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Barkan', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520920591']
1582,32459016,A randomized controlled study of 6% gabapentin topical formulation for chronic kidney disease-associated pruritus.,"BACKGROUND


Novel agents with good safety profiles are needed in the management of chronic kidney disease-associated pruritus (CKD-AP). This study aims to assess the efficacy and safety of topical gabapentin in the treatment of CKD-AP.
METHODS


The authors conducted a randomized, double-blind, vehicle-controlled study. The key inclusion criteria were: (i) patients on hemodialysis for at least 8 weeks, and (ii) a baseline visual analog scale (VAS) pruritus score ≥5. Patients were randomized into two groups. Topical 6% gabapentin was used in the experimental group while plain permeation cream was used for the control group. The primary endpoint was the mean change in pruritus scores using the VAS (MCPS-VAS) from baseline after 1 and 2 weeks of once daily application.
RESULTS


Thirty patients (15 per group) were included in the analysis. Treatment with 6% topical gabapentin resulted in significantly decreased mean pruritus scores at 1 week (mean score 2.7; range 0-5; P < 0.001) and 2 weeks (mean score 1.3, range 0-5; P < 0.001) from baseline (mean score 5.9; range 5-8). The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week. However, the MCPS-VAS of the experimental group (mean change -4.6; range 0-7) was significantly greater (P = 0.01) compared to control (mean change -2.6; range -1 to 5) after 2 weeks. There were no drug-related adverse events reported.
CONCLUSION


Our results suggest that short-term use of topical gabapentin may significantly decrease CKD-AP severity after 2 weeks with no reported acute adverse events.",2020,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"['chronic kidney disease-associated pruritus', 'Thirty patients (15 per group) were included in the analysis']","['gabapentin topical formulation', 'plain permeation cream', 'topical gabapentin', 'Topical 6% gabapentin']","['mean change in pruritus scores using the VAS (MCPS-VAS', 'CKD-AP severity', 'efficacy and safety', 'MCPS-VAS', 'baseline visual analog scale (VAS) pruritus score ≥5', 'mean pruritus scores']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.0514989,The MCPS-VAS of the two groups were not significantly different (P = 0.8) after 1 week.,"[{'ForeName': 'Terese Monette O', 'Initials': 'TMO', 'LastName': 'Aquino', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Karla Angela C', 'Initials': 'KAC', 'LastName': 'Luchangco', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Sanchez', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}, {'ForeName': 'Vermen M', 'Initials': 'VM', 'LastName': 'Verallo-Rowell', 'Affiliation': 'Skin and Cancer Foundation, Inc., Pasig City, Philippines.'}]",International journal of dermatology,['10.1111/ijd.14953']
1583,32459035,"A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter Clinical Trial to Assess the Safety of 0.005% Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women with Early Stage Breast Cancer in Treatment with Aromatase Inhibitor in the Adjuvant Setting.","LESSONS LEARNED


The levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone remained unchanged after a 12-week treatment with 0.005% estriol vaginal gel in postmenopausal women receiving nonsteroidal aromatase inhibitors for hormone receptor-positive early breast cancer. These results support the safety of 0.005% estriol vaginal gel for the treatment of bothering symptoms of vulvovaginal atrophy in breast cancer survivors. The results provide clinicians with confidence in the use of this product in women who do not experience symptom relief with nonhormonal remedies.
BACKGROUND


Symptoms of vulvovaginal atrophy associated with treatment with nonsteroidal aromatase inhibitors (NSAIs) negatively impact patients' quality of life and may affect adherence to NSAIs. Vaginal estrogens effectively improve these symptoms, although their safe use in breast cancer survivors remains unclear.
METHODS


Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness were randomized to 0.005% estriol vaginal gel or placebo for 12 weeks. Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH), were analyzed at baseline and at weeks 1, 3, 8, and 12. The primary safety outcome was the variation in serum FSH from baseline to week 12.
RESULTS


Sixty-one women (mean age, 59 years) enrolled in the study. Small oscillations were observed in FSH and LH, although they were always maintained within the postmenopausal range. No significant differences were found in the variation of FSH and LH between baseline and week 12 from the physiological variation observed before treatment. Women receiving 0.005% estriol vaginal gel had slightly increased estriol levels at weeks 1 and 3, with a subsequent reduction until normalizing at week 12; estradiol and estrone remained the below limit-of-quantitation in almost all samples.
CONCLUSION


Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI. A transient negligible absorption of estriol and a nonsignificant variation of FSH after 12 weeks were observed. These findings provide confidence for the safe use of 0.005% estriol vaginal gel in women with breast cancer with an indication for treatment with vaginal estrogens.",2020,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","['women with breast cancer with an indication for treatment with vaginal estrogens', 'Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness', 'postmenopausal women receiving', 'women with breast cancer receiving NSAI', 'breast cancer survivors', 'Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting', 'women who do not experience symptom relief with nonhormonal remedies', 'Sixty-one women (mean age, 59\u2009years) enrolled in the study']","['estriol vaginal gel', 'nonsteroidal aromatase inhibitors (NSAIs', 'Placebo', 'Estriol Vaginal Gel', 'Ultralow-dose 0.005% estriol vaginal gel', 'estriol vaginal gel or placebo', 'nonsteroidal aromatase inhibitors']","['Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'variation of FSH and LH', 'variation in serum FSH', 'estrogens, FSH, and LH levels', 'estriol levels', 'levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517389', 'cui_str': '0.005'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0337435', 'cui_str': 'Estriol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",61.0,0.0682912,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Rovira', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Jaén, Jaén, Spain.'}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institute and Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo-De Las Heras', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'Medical Department, Italfarmaco, SA, Madrid, Spain.'}]",The oncologist,['10.1634/theoncologist.2020-0417']
1584,32453997,"Does a single bout of exercise impacts BDNF, oxidative stress and epigenetic markers in spinal cord injury patients?","Our aim was to evaluate the impact of a single bout of exercise, consisting of a gait training session with body weight support (BWS), on histone acetylation status (global histone H4 and H3 acetylation levels), brain-derived neurotrophic factor (BDNF) levels, and oxidative stress markers in peripheral blood of individuals with chronic spinal cord injury (SCI). We also set out to compare these responses with those recorded after gait training performed using a walker and with no BWS. The subjects (nearly all with an incomplete spinal cord lesion) were each submitted to two 60-minute experimental sessions on separate days with a 1- week wash-out period between the interventions. The order of the sessions was randomized. Blood samples were collected before and after each experimental trial for measurement of biomarkers. The histone acetylation status and BDNF levels remained unchanged after both interventions. After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators. Instead, elevations in AOPP and nitrite concentrations, in addition to increased levels of glutathione and catalase activity, were found after the walker training. A single bout of gait training, be it conducted on a treadmill with BWS or using a walker without BWS, is not able to alter BDNF levels and histone acetylation status in SCI patients. However, these trials can modulate oxidative stress parameters, seemingly in a protocol-dependent manner.",2019,"After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators.","['subjects (nearly all with an incomplete spinal cord lesion', 'SCI patients', 'peripheral blood of individuals with chronic spinal cord injury (SCI', 'spinal cord injury patients']","['gait training', 'gait training session with body weight support (BWS']","['histone acetylation status (global histone H4 and H3 acetylation levels), brain-derived neurotrophic factor (BDNF) levels, and oxidative stress markers', 'histone acetylation status and BDNF levels', 'levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances', 'levels of glutathione and catalase activity', 'BDNF levels and histone acetylation status', 'AOPP and nitrite concentrations']","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0019652', 'cui_str': 'Histone'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}]",,0.0555968,"After the treadmill training, the participants showed a strong increase in levels of oxidative stress markers [plasma advanced oxidation protein products (AOPPs), nitrite and thiobarbituric acid-reactive substances] without changes in antioxidant mediators.","[{'ForeName': 'Melissa Grigol', 'Initials': 'MG', 'LastName': 'Goldhardt', 'Affiliation': ''}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Andreia', 'Affiliation': ''}, {'ForeName': 'Gilson P', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': ''}, {'ForeName': 'Ivy Reichert', 'Initials': 'IR', 'LastName': 'da Silva', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': ''}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Rostirola Elsner', 'Affiliation': ''}]",Functional neurology,[]
1585,32467540,The effectiveness of diabetes medication therapy adherence clinic to improve glycaemic control among patients with type 2 diabetes mellitus: a randomised controlled trial.,"INTRODUCTION


In Malaysia, Diabetes Medication Therapy Adherence Clinic (DMTAC) in hospital settings significantly improved patients' glycaemic control and cardiovascular risk. Until now no randomised controlled trial of DMTAC has been done in a primary care setting where the access to subspecialist services (endocrinologists, expensive medication, etc.) is limited. The objective of this research is to compare the glycaemic control among diabetes mellitus (DM) patients between those received additional DMTAC service and those received normal clinic service in primary care settings.
MATERIALS AND METHOD


This was a parallel, randomised controlled study. The selected participants were patients aged 18 to 70 years with type 2 DM on diabetic medication who were being treated in Kota Samarahan Health Clinic with HbA1c above 8% and who never attended any education of DM prior to the study. The control group received normal clinic visits with consultations by a medical officer. The intervention group received four or more DMTAC visits in addition to normal clinic visits. The primary outcomes were HbA1c while the secondary outcomes were the occurrence of severe hypoglycaemia, weight gain and medication compliance of patients. The subjects were randomised by numbered envelope opened chronologically by the investigator during the initial assessment. All health care professionals (nurse, lab staff and medical officer) except DMTAC pharmacist managing the subjects were blinded as there were no markings on the patients notes indicating that they were in this study. The demographic data was collected during screening while health data including glycated haemoglobin (HbA1c) levels were collected at baseline, sixth month and one year.
RESULTS


In all, 100 patients were randomised into control and intervention groups (n=50 per arm). The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627). Both study groups had similar significant changes of subjects from non-compliance to compliance (control group, n=11 vs. intervention group, n=10). The changes of BMI after 12 months between control group (0.24 kg/m2) and intervention group (0.24 kg/m2) was not significant (p=0.910). There were no episodes of severe hypoglycaemia detected in both groups.
CONCLUSION


The addition of DMTAC service in primary care can improve glycaemic control among patients. The study was registered in the National Medical Research Register (Malaysia): NMRR-13-1449-18955.",2020,"The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627).","['diabetes mellitus (DM) patients between those received additional DMTAC service and those received normal clinic service in primary care settings', 'patients with type 2 diabetes mellitus', 'selected participants were patients aged 18 to 70 years with type 2 DM on diabetic medication who were being treated in Kota Samarahan Health Clinic with HbA1c above 8% and who never attended any education of DM prior to the study', 'National Medical Research Register (Malaysia', 'patients', '100 patients']","['DMTAC', 'diabetes medication therapy adherence clinic', 'normal clinic visits with consultations by a medical officer']","['change of HbA1c', 'glycaemic control and cardiovascular risk', 'severe hypoglycaemia', 'changes of BMI', 'glycated haemoglobin (HbA1c) levels', 'glycaemic control', 'occurrence of severe hypoglycaemia, weight gain and medication compliance of patients']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0557286', 'cui_str': 'No formal education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",100.0,0.0674614,"The change of HbA1c in the intervention group (mean=-1.58) was significantly more than the control group (mean=-0.48) at 12 months with a mean difference of -1.10% (p=0.005, Cohen's d=0.627).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Alison', 'Affiliation': 'Klinik Kesihatan Kota Samarahan, 94300 Kota Samarahan, Sarawak, and Universiti Malaysia Sarawak, Malaysia. chai.alison@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anselm', 'Affiliation': 'Universiti Malaysia Sarawak, Malaysia.'}]",The Medical journal of Malaysia,[]
1586,32467546,Bioequivalence and pharmacokinetic comparison of two fixed dose combination of Metformin/ Glibenclamide formulations in healthy subjects under fed condition.,"AIM


This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet).
MATERIALS AND METHODS


This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS


The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION


It can be concluded that the test preparation is bioequivalent to the reference preparation.",2020,"Throughout the study period, no serious drug reaction was observed.","['healthy subjects under fed condition', '28 adult male subjects']","['standardized high-fat and high-calorie breakfast', 'Metformin/ Glibenclamide formulations', 'metformin/glibenclamide tablets', 'glibenclamide and metformin']","['headache (n=2) and excessive hunger', 'Plasma levels', 'AUC0-t, AUC0-∞, and Cmax of the test preparation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2936315', 'cui_str': 'Test Preparation'}]",28.0,0.0305593,"Throughout the study period, no serious drug reaction was observed.","[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Chang', 'Affiliation': 'Hospital Raja Permaisuri Bainun, Clinical Research Centre, Ipoh, Perak, Malaysia. davidcct.crc@gmail.com.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Ang', 'Affiliation': 'Hospital Raja Permaisuri Bainun, Clinical Research Centre, Ipoh, Perak, Malaysia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Wong', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Chin', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Lim', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Attest Research Sdn Bhd, Kawasan Perindustrian Bayan Lepas, 11900 Penang, Malaysia.'}]",The Medical journal of Malaysia,[]
1587,32468955,Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial.,"PURPOSE


In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.
PATIENTS AND METHODS


Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease.
RESULTS


There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48;  P  < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85;  P  = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
CONCLUSION


In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.",2020,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","['patients with HER2-positive breast cancer', 'Patients', 'Previously Treated HER2-Positive Breast Cancer', 'participants with BMs', 'patients with HER2-positive breast cancer with BMs', '291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm', 'patients with measurable intracranial disease', 'patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs']","['baseline brain magnetic resonance imaging', 'Tucatinib Plus Trastuzumab and Capecitabine', 'tucatinib or placebo, in combination with trastuzumab and capecitabine']","['risk of intracranial progression or death', 'Risk of death', 'ORR-IC', 'Median OS', 'risk of death', 'intracranial efficacy and survival', 'Median CNS-PFS', 'Intracranial Efficacy and Survival', 'intracranial objective response rate (ORR-IC', 'antitumor activity against BMs', 'CNS-PFS (intracranial progression or death) and overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]",291.0,0.139198,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%;  P  = .03).
","[{'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Anders', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology-Nashville, Nashville, TN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles Medical Center/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'Royal Marsden National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Hospital Universitario Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Zelnak', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'DiGiovanna', 'Affiliation': 'Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Regan"", 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'Christie NHS Foundation Trust, Manchester Academic Health Science Centre & Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Providence Cancer Institute, Portland, OR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Cancer Research Centre, Edinburgh, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, University of Milano, Milan, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer-Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'JoAl', 'Initials': 'J', 'LastName': 'Mayor', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGoldrick', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Xuebei', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00775']
1588,32450063,Comparison of Removable Rigid Dressing and Elastic Bandage for Residual Limb Maturation in Transtibial Amputees: A Randomized Controlled Trial.,"OBJECTIVE


To determine the effect of a removable rigid dressing (RRD) on the time to residual limb maturation compared with elastic bandage (EB) in transtibial amputees.
DESIGN


Experimental single-blinded (assessor-blinded) randomized controlled trial.
SETTING


Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital.
PARTICIPANTS


Transtibial amputees (N=25) with immature residual limb.
INTERVENTION


Participants were allocated to use RRD or EB to achieve residual limb maturation, and all participants in both groups were trained with the same preprosthetic program.
MAIN OUTCOME MEASURES


The time to residual limb maturation, patient satisfaction, and complications were compared between the 2 groups.
RESULTS


Median time to residual limb maturation was significantly lower in the RRD group (median, 28d [interquartile range, 17-51d]) than in the EB group (median, 54d [interquartile range, 30-77d]; P=.020). After accounting for time since amputation, maturation time remained significantly lower in the RRD group (adjusted hazard ratio, 3.32; 95% CI, 1.08-10.20; P=.036). There was no significant difference in complications or patient satisfaction.
CONCLUSION


In postoperative management of transtibial amputation, the use of RRD had a significantly shorter period to residual limb maturation when compared with the EB group.",2020,"There was no significant difference in complications or patient satisfaction.
","['Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital', 'Twenty-five transtibial amputees with immature residual limb', 'transtibial amputees']","['removable rigid dressing (RRD', 'elastic bandage (EB', 'removable rigid dressing and elastic bandage', 'RRD or EB']","['residual limb maturation', 'time to residual limb maturation, patient satisfaction and complications', 'time since amputation, maturation time', 'complications or patient satisfaction', 'Median time to residual limb maturation']","[{'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.126639,"There was no significant difference in complications or patient satisfaction.
","[{'ForeName': 'Nantawan', 'Initials': 'N', 'LastName': 'Koonalinthip', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: col_kate@hotmail.com.'}, {'ForeName': 'Aungsumalin', 'Initials': 'A', 'LastName': 'Sukthongsa', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Siriporn', 'Initials': 'S', 'LastName': 'Janchai', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.009']
1589,32450080,Access to single-visit IUD insertion at obstetrician-gynecology practices in Ohio: An audit study.,"OBJECTIVE


Single-visit intrauterine device (IUD) insertion protocols are recommended. We assessed the availability of single-visit IUD insertions, and whether access to these services varies by age, race or parity.
STUDY DESIGN


Using audit study methodology, we called a random sample of 396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment. Callers used eight standardized scripts and noted justifications for protocols offered by clinic staff. Practices were randomized to follow a balanced 3×2 factorial design, whereby practices were assigned to one of two conditions: (1) age (18 vs. 30 years of age); (2) race (white vs. black); and (3) parity. Multivariable logistic regression was used to control for clinics rural vs. urban location while considering the effects of these variables on service provision.
RESULTS


Almost all (95%) of the practices called offered IUD placement, of which 92% required multiple appointments for IUD insertion. Although access to single-visit IUD services did not vary by age or race, we found that parity was associated with clinics' willingness to schedule a single-visit insertion visit (OR = 3.84, 95% CI = 1.23, 12.04). The most frequent justification provided by clinic staff for their multiple-appointment protocol was the need to verify insurance coverage or order the device directly through the patient's insurance company.
CONCLUSION


Ohio patients seeking IUD placement must typically make more than one clinic visit.
IMPLICATIONS


Efforts are needed to reassure Ohio clinics that IUDs are routinely covered by insurers and to increase access to same-day IUD placement for women in Ohio, as the requirement to attend multiple clinics appointments to obtain a desired contraceptive may pose an insurmountable barrier to care for those with the fewest resources.",2020,"RESULTS


Almost all (95%) of the practices called offered IUD placement,",['396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment'],[],[],"[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],[],396.0,0.233788,"RESULTS


Almost all (95%) of the practices called offered IUD placement,","[{'ForeName': 'Jaclyn J', 'Initials': 'JJ', 'LastName': 'Serpico', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA; The Ohio State University, College of Arts and Sciences, Columbus, OH 43210, USA. Electronic address: serpico.6@osu.edu.'}, {'ForeName': 'JaNelle M', 'Initials': 'JM', 'LastName': 'Ricks', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA.'}, {'ForeName': 'Wendy G', 'Initials': 'WG', 'LastName': 'Smooth', 'Affiliation': 'The Ohio State University, College of Arts and Sciences, Columbus, OH 43210, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Romanos', 'Affiliation': 'Planned Parenthood of Greater Ohio, Columbus, OH 43215, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Brook', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA; The Ohio State University Wexner Medical Center, Medical Scientist Training Program, Columbus, OH 43210, USA.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallo', 'Affiliation': 'The Ohio State University, College of Public Health, Columbus, OH 43210, USA.'}]",Contraception,['10.1016/j.contraception.2020.05.007']
1590,32451708,Bone turnover markers as an aid to monitor osteoporosis following allogeneic hematopoietic stem cell transplantation.,"Bone turnover markers (BTMs) are useful parameters for assessing fracture risk and unlike bone mineral density (BMD), can be measured at any institution. However, BTM values have not been established in patients post-allogeneic hematopoietic stem cell transplantation (allo-HSCT). We investigated the practicality of BTMs in patients who underwent allo-HSCT by measuring levels of the serum bone resorption marker, tartrate-resistant acid phosphatase-5b (TRACP-5b), and the bone formation marker, bone-specific alkaline phosphatase (BAP), together with BMD, 1 month before and 6 months after allo-HSCT. Patients were classified into either the alendronate group (n = 14) if alendronate treatment (35 mg orally per week) was administered before allo-HSCT or within 1 month after allo-HSCT, or the control group (n = 16), in which patients did not receive alendronate treatment. Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups. Additionally, the percentage changes in BMD at the lumbar spine were negatively associated with the TRACP-5b levels 6 months after allo-HSCT (p = 0.03, r = 0.40). Our results indicate the possible effectiveness of alendronate treatment in allo-HSCT patients. BTM levels could be useful to monitor the BMD changes.",2020,"Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups.","['allogeneic hematopoietic stem cell transplantation', 'patients post-allogeneic hematopoietic stem cell transplantation (allo-HSCT', 'allo-HSCT patients', 'patients who underwent allo-HSCT by measuring levels of the serum bone resorption marker, tartrate-resistant acid phosphatase-5b (TRACP-5b), and the bone formation marker, bone-specific alkaline phosphatase (BAP), together with BMD, 1\xa0month before and 6\xa0months after allo-HSCT']","['alendronate treatment', 'alendronate treatment (35\xa0mg orally per week) was administered before allo-HSCT', 'alendronate']","['femoral neck', 'BMD at the lumbar spine', 'Bone turnover markers (BTMs', 'bone mineral density (BMD', 'TRACP-5b levels', 'BAP levels', 'BTM levels']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}]",,0.0279843,"Despite the high frequency of corticosteroids users in the alendronate group (71.4 vs. 18.9%; p < 0.01), the mean percentage changes in BMD at the lumbar spine (- 2.9 vs. - 3.1%; p = 0.44) and femoral neck (- 3.2 vs. - 4.1%; p = 1.00), TRACP-5b levels (- 4.8 vs. 9.9%; p = 0.45), and BAP levels (6.9 vs. 1.0%; p = 0.85) during 6 months did not differ significantly between the alendronate and control groups.","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kurosawa', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Doki', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan. n-doki@cick.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Senoo', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Shinshu University School of Medicine, Matsumoto city, Nagano, 390-8621, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Kishida', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Nagata', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Konishi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kaito', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Yoshifuji', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Matsuyama', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Shirane', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Inamoto', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Toya', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Najima', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Muto', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kakihana', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Sakamaki', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Ohashi', 'Affiliation': 'Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyo-ku, Tokyo, 113-0021, Japan.'}]",Annals of hematology,['10.1007/s00277-020-04090-7']
1591,32452549,Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.,"BACKGROUND


Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.
OBJECTIVE


To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
METHODS


Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.
RESULTS


One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.
CONCLUSION


Protection with lanadelumab started from the first dose and continued throughout the entire study period.",2020,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","['125 patients', 'Eligible patients with HAE type I/II received']","['placebo', 'Lanadelumab', 'lanadelumab', 'lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo', 'lanadelumab versus placebo']","['durable-HAE attack rate', 'mean monthly attack rate', 'attacks requiring acute treatment', 'HAE attack rate', 'moderate/severe attacks', 'attack free']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",125.0,0.120587,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge and University College London Hospitals, London, UK.""}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, P.C., Chevy Chase, MD, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'Salomé', 'Initials': 'S', 'LastName': 'Juethner', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy and Asthma Research Associates, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14416']
1592,32453996,Effects of Constraint-Induced Movement Therapy on upper limb activity according to a bi-dimensional kinematic analysis in progressive multiple sclerosis patients: a randomized single-blind pilot study.,"Multiple sclerosis (MS) is a chronic disease of the central nervous system, characterized by demyelinization and axonal loss resulting, in 66% of cases, in upper limb motor impairment. The effects of constraint-induced movement therapy (CIMT) have recently been investigated in MS patients. The aim of this randomized single-blind pilot study was to assess the effects of CIMT on upper limb activity, specifically smoothness of movement, in patients affected by progressive MS. Patients affected by MS, and reporting reduced use primarily of one upper limb, were enrolled and randomly allocated to two different groups: a CIMT group, where treatment was performed with the less affected limb immobilized by a splint, and a control group, submitted to intensive bi-manual treatment. All evaluations were performed at baseline (T0) and after two weeks of treatment (T1) by an operator unaware of the patients' allocation. The primary outcome was the difference in movement smoothness, measured by means of a bidimensional kinematic evaluation. Secondary outcomes were: endpoint error and arm trajectory mean speed. Furthermore, patients performed the Hand Grip Strength Test (HGS) and 9-Hole Peg Test (9HPT), for both arms, at both time points. Ten patients with MS (4 males, 6 females; mean age 51.0±7.7 years) were randomly allocated to the CIMT group (n=5) and control group (n=5). There were no significant differences between groups in any of the data assessed at baseline. In the CIMT group subjects, the treatment effect, in terms of movement smoothness, was significant at the more affected limb (p=0.0376). The CIMT group displayed statistically significant improvements, versus the baseline values, in muscle strength (HGS:22.4±8.3 vs 26.0±6.0; p<0.05) and dexterity (9HPT: 31.8±6.1 vs 27.4±4.9; p<0.05) of the more affected limb. A positive, although not significant, trend in terms of muscle strength and upper limb dexterity was observed, for both limbs, in the control group after the two-week treatment. Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT. Moreover, in the CIMT group, a non-significant worsening of muscle strength was recorded for the less affected upper limb.",2019,Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT.,"['progressive multiple sclerosis patients', 'Ten patients with MS (4 males, 6 females; mean age 51.0±7.7 years', 'MS patients', 'Patients affected by MS, and reporting reduced use primarily of one upper limb', 'patients affected by progressive MS']","['CIMT', 'Constraint-Induced Movement Therapy', 'constraint-induced movement therapy (CIMT', 'limb immobilized by a splint, and a control group, submitted to intensive bi-manual treatment']","['endpoint error and arm trajectory mean speed', 'muscle strength and upper limb dexterity', 'Hand Grip Strength Test (HGS) and 9-Hole Peg Test (9HPT', 'muscle strength', 'movement smoothness, measured by means of a bidimensional kinematic evaluation', 'upper limb activity']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0579116', 'cui_str': 'Upper limb activities'}]",10.0,0.0285574,Bi-dimensional kinematic evaluation demonstrated that the CIMT group showed a significant reduction of endpoint error and higher mean speed for the more affected arm; these data are in line with the significant improvements recorded on the HGS and 9HPT.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mauro', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priano', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baudo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bigoni', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': ''}]",Functional neurology,[]
1593,32455860,Impact of Meal Timing and Chronotype on Food Reward and Appetite Control in Young Adults.,"Early meal timing and chronotype are associated with lower BMI, but their impact on appetite is poorly understood. We examined the impact of meal timing and chronotype on appetite and food reward. Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ). Participants attended the laboratory after ≥3 h fast on two occasions for early (AM; 8-10 a.m.) and late (PM; 4-6 p.m.) counterbalanced testing sessions in a 2 × 2 design. Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire) were measured in response to a standardized test meal. LC was associated with higher BMI ( p  = 0.01), but not with EI or TFEQ. The composite appetite score was lower in AM than PM (M Δ = -5 (95% CI -10, -0.2) mm,  p  = 0.040). Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038). Liking and wanting high-fat food were lower in AM than PM ( p  ≤ 0.004). The late chronotype was associated with greater desire for high-fat food ( p  = 0.006). To conclude, early meal timing and early chronotype are independently associated with smaller appetite and lower desire for high-fat food.",2020,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"['Forty-four adults were divided into early (EC; Morningness-Eveningness Questionnaire (MEQ) score = 55 ± 5) or', 'Young Adults']","['late chronotype (LC; MEQ score = 40 ± 6) and assessed for body mass index, habitual energy intake (EI; three-day online dietary record) and eating behavior traits from the Three-Factor Eating Questionnaire (TFEQ', 'Meal Timing and Chronotype']","['Perceived test meal fillingness', 'Appetite ratings and food reward (validated diurnal Leeds Food Preference Questionnaire', 'composite appetite score', 'higher BMI', 'Liking and wanting high-fat food']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}]",44.0,0.024407,Perceived test meal fillingness was higher in AM than PM and EC compared to LC ( p  ≤ 0.038).,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Shaea', 'Initials': 'S', 'LastName': 'Alkahtani', 'Affiliation': 'Department of Exercise Physiology, College of Sport Sciences and Physical Activity, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alhussain', 'Affiliation': 'Department of Food Science and Nutrition, College of Food and Agricultural Sciences, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, DK-2028 Gentofte, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, UK.'}]",Nutrients,['10.3390/nu12051506']
1594,32458506,"A randomised trial comparing conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels between semen collection at home and at the clinic.","The aim of the randomised trial was to compare conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels between semen samples collected at home and at the clinic. We recruited 110 men with a history of infertility for at least 1 year from the outpatient andrology clinic. Each man collected two semen samples, one at home and one at the clinic. Men were randomly assigned into the home first (n = 55) or clinic first (n = 55) groups. The primary outcome was sperm concentration. There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01). Consistent results were obtained when comparing home-collected and clinic-collected samples within individuals. Men can be offered the option to collect semen samples at home for examination or assisted reproduction without compromising semen quality, especially for those with difficulty in producing semen samples at the clinic.",2020,"There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01).",['110 men with a history of infertility for at least 1\xa0year from the outpatient andrology clinic'],[],"['sperm DNA fragmentation levels and satisfaction levels', 'sperm concentration, sperm DNA fragmentation levels', 'satisfaction levels', 'sperm concentration', 'conventional semen parameters, sperm DNA fragmentation levels and satisfaction levels']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",110.0,0.0368193,"There was no significant difference in sperm concentration, sperm DNA fragmentation levels or other conventional semen parameters between home first and clinic first samples (p > .05), while satisfaction levels were significantly higher for home first samples (p < .01).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Yong-Gang', 'Initials': 'YG', 'LastName': 'Duan', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'William S B', 'Initials': 'WSB', 'LastName': 'Yeung', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ernest H Y', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Center of Assisted Reproduction and Embryology, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.'}]",Andrologia,['10.1111/and.13628']
1595,32462483,Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial.,"Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Mode of surfactant administration has evolved towards less invasive technique in the last few years. We randomised 58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive surfactant by InSurE or minimally invasive surfactant therapy (MIST). Non-invasive positive pressure ventilation (NIPPV) was used as primary respiratory support. The main objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32). No difference was observed in terms of hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality.Conclusion: There is no difference between MIST and InSurE in preterm neonates with RDS with NIPPV as a primary mode of respiratory support. Larger multicentre studies are needed to further explore differences in treatment failure and other secondary outcomes.Trial registration: www.ctri.nic.in id CTRI/2019/03/017992, registration date March 8, 2019. What is Known • InSurE is commonly used for many years for treatment of RDS in preterm neonates. • MIST has been introduced as a newer tool. What is New • MIST with feeding tube is comparable with InSurE in preterm infants with RDS in developing countries. •NIPPV can be used as primary respiratory support for MIST.",2020,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","['Preterm neonates with respiratory distress syndrome (RDS', 'preterm infants with RDS', 'preterm neonates with RDS with', '58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive', 'preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation']","['surfactant by intubate surfactant extubate (InSurE) technique', 'Minimally invasive surfactant therapy', 'invasive positive pressure ventilation (NIPPV', 'surfactant by InSurE or minimally invasive surfactant therapy (MIST', 'NIPPV']","['need of IMV', 'hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality', 'need of invasive mechanical ventilation (IMV', 'life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",58.0,0.200468,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","[{'ForeName': 'Bhupendra Kumar', 'Initials': 'BK', 'LastName': 'Gupta', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Anindya Kumar', 'Initials': 'AK', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Suchandra', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India. bijansaha18@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03682-9']
1596,32462979,Early and sustained symptom improvement with umeclidinium/vilanterol  versus  monotherapy in COPD: a  post hoc  analysis of the EMAX randomised controlled trial.,"BACKGROUND


In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained.
METHODS


Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured  via  an electronic diary and analysed initially in 4-weekly periods.  Post hoc  analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1-8), and association between E-RS:COPD responder status at Weeks 1-4 and later time points.
RESULTS


In the intent-to-treat population ( n  = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60-85%) retained their Weeks 1-4 E-RS:COPD responder/non-responder status at Weeks 21-24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1-4, 70% were responders at Weeks 21-24.
CONCLUSION


Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI  versus  either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient's likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care.
CLINICAL TRIAL REGISTRATION


NCT03034915, 2016-002513-22 (EudraCT Number).  The reviews of this paper are available via the supplemental material section.",2020,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"['chronic obstructive pulmonary disease (COPD', 'COPD', '2016-002513-22 (EudraCT Number', 'patients with COPD with']","['umeclidinium/vilanterol  versus  monotherapy', 'E-RS:COPD', 'bronchodilator therapy', 'EMAX', 'umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol']","['daily E-RS:COPD score and rescue medication', 'COPD stability']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.52709,Treatment differences for UMEC/VI  versus  either monotherapy plateaued by Week 4-8 and were sustained at Weeks 21-24; improvements were consistently greater with UMEC/VI.,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Crisor LLC, Clinical Research Institute, 3860 Crater Lake Ave., Medford, OR 97504, USA.'}, {'ForeName': 'Isabelle H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Keeley', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926949']
1597,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES


Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS


Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS


Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS


The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS


Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
1598,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES


Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery.
STUDY DESIGN


A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions).
RESULTS


There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051).
CONCLUSIONS


Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014']
1599,32580883,"Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial.","BACKGROUND


We aimed to identify a five-fraction schedule of adjuvant radiotherapy (radiation therapy) delivered in 1 week that is non-inferior in terms of local cancer control and is as safe as an international standard 15-fraction regimen after primary surgery for early breast cancer. Here, we present 5-year results of the FAST-Forward trial.
METHODS


FAST-Forward is a multicentre, phase 3, randomised, non-inferiority trial done at 97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK. Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible. We randomly allocated patients to either 40 Gy in 15 fractions (over 3 weeks), 27 Gy in five fractions (over 1 week), or 26 Gy in five fractions (over 1 week) to the whole breast or chest wall. Allocation was not masked because of the nature of the intervention. The primary endpoint was ipsilateral breast tumour relapse; assuming a 2% 5-year incidence for 40 Gy, non-inferiority was predefined as ≤1·6% excess for five-fraction schedules (critical hazard ratio [HR] of 1·81). Normal tissue effects were assessed by clinicians, patients, and from photographs. This trial is registered at isrctn.com, ISRCTN19906132.
FINDINGS


Between Nov 24, 2011, and June 19, 2014, we recruited and obtained consent from 4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule. At a median follow-up of 71·5 months (IQR 71·3 to 71·7), the primary endpoint event occurred in 79 patients (31 in the 40 Gy group, 27 in the 27 Gy group, and 21 in the 26 Gy group); HRs versus 40 Gy in 15 fractions were 0·86 (95% CI 0·51 to 1·44) for 27 Gy in five fractions and 0·67 (0·38 to 1·16) for 26 Gy in five fractions. 5-year incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions). At 5 years, any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall was reported for 98 of 986 (9·9%) 40 Gy patients, 155 (15·4%) of 1005 27 Gy patients, and 121 of 1020 (11·9%) 26 Gy patients. Across all clinician assessments from 1-5 years, odds ratios versus 40 Gy in 15 fractions were 1·55 (95% CI 1·32 to 1·83, p<0·0001) for 27 Gy in five fractions and 1·12 (0·94 to 1·34, p=0·20) for 26 Gy in five fractions. Patient and photographic assessments showed higher normal tissue effect risk for 27 Gy versus 40 Gy but not for 26 Gy versus 40 Gy.
INTERPRETATION


26 Gy in five fractions over 1 week is non-inferior to the standard of 40 Gy in 15 fractions over 3 weeks for local tumour control, and is as safe in terms of normal tissue effects up to 5 years for patients prescribed adjuvant local radiotherapy after primary surgery for early-stage breast cancer.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"['Between Nov 24, 2011, and June 19, 2014', '4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule', 'Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible', '97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK']","['adjuvant radiotherapy (radiation therapy', 'adjuvant local radiotherapy', 'Hypofractionated breast radiotherapy']","['normal tissue effect risk', 'Normal tissue effects', 'ipsilateral breast tumour relapse', 'moderate or marked clinician-assessed normal tissue effects', '5-year incidence for 40 Gy, non-inferiority', 'incidence of ipsilateral breast tumour relapse']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]",4096.0,0.236289,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Murray Brunt', 'Affiliation': 'University Hospitals of North Midlands and University of Keele, Stoke on Trent, UK; Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK. Electronic address: fastforward-icrctsu@icr.ac.uk.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Duncan A', 'Initials': 'DA', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospital, Treliske, Truro, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Sydenham', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bloomfield', 'Affiliation': 'Brighton and Sussex University Hospitals, Brighton, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Nuffield Health Cheltenham Hospital, Cheltenham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Churn', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cleator', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Coles', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK; Torbay Hospital NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Harnett', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hopwood', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kirby', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Zohal', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Sawyer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Navita', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Liba', 'Initials': 'L', 'LastName': 'Stones', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Bebington, Wirral, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Yarnold', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30932-6']
1600,32467415,A Telemedicine Approach to Increase Treatment of Alcohol Use Disorder in Primary Care: A Pilot Feasibility Study.,"BACKGROUND AND AIMS


Unhealthy drinking is a leading threat to health, yet few people with alcohol use disorder (AUD) receive treatment. This pilot tested the feasibility of addiction medicine video consultations in primary care for improving AUD medication adoption and specialty treatment initiation.
METHODS


Primary care providers (PCPs) received training and access to on-call addiction medicine consultations. Feasibility measures were training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback. Secondary outcomes were utilization, prescription and treatment initiation rates, and case reports. χ tests were used to compare prescription and treatment initiation rates for consult recipients and non-recipients.
RESULTS


Ninety-one PCPs (71.1%) attended a training, and 60 (65.9%) provided feedback. Of those, 37 (64.9%) mentioned pharmacotherapy and 41 (71.9%) intended to use the video consult service. Of 27 users, 19 provided feedback; 12 (63.1%) rated its value at 8 or above, on a scale of 1 to 10 (average 6.9). The most useful aspect was immediacy, and users wanted an easier workflow and increased consultant availability. Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
CONCLUSIONS


PCP training attendance and feedback suggest that an addiction telemedicine consult service would be valuable to PCPs and might increase AUD medication uptake and specialty addiction treatment initiation. However, future research should include significant modifications to the piloted telemedicine model: robust staffing and simpler, more flexible methods for PCPs to obtain consults.",2020,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","['Alcohol Use Disorder in Primary Care', 'Primary care providers (PCPs) received']","['training and access to on-call addiction medicine consultations', 'naltrexone', 'addiction medicine video consultations']","['training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback', 'utilization, prescription and treatment initiation rates, and case reports']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4505067', 'cui_str': 'Addiction Medicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}]",,0.0441061,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA (AL, DDS, WL, CW, SS), Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Avenue, San Francisco, CA (DDS), The Permanente Medical Group, Addiction Medicine and Recovery Services, 380\u200aW MacArthur Blvd, Oakland, CA (CC), The Permanente Medical Group, East Bay Technology, 901 Nevin Avenue, Richmond, CA (EG).'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Weisner', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Corriveau', 'Affiliation': ''}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Gizzi', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sterling', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000666']
1601,32468187,Effect of Metformin vs. Placebo in Combination with Insulin Analogues on Bone Markers P1NP and CTX in Patients with Type 2 Diabetes Mellitus.,"Preclinical studies have shown a potential osteoanabolic effect of metformin but human studies of how metformin affects bone turnover are few. A post hoc sub-study analysis of an 18-month multicenter, placebo-controlled, double-blinded trial in type 2 diabetes mellitus (T2DM), randomizing participants to metformin versus placebo both in combination with different insulin analogue regimens (Metformin + Insulin vs. Placebo + Insulin). Patients were not treatment naive at baseline, 83% had received metformin, 69% had received insulin, 57.5% had received the combination of metformin and insulin before entering the study. Bone formation and resorption were assessed by measuring, N-terminal propeptide of type I procollagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) at baseline and end of study. The influence of gender, age, smoking, body mass index (BMI), T2DM duration, glycosylated hemoglobin A1c (HbA1c), c-reactive protein (CRP) and insulin dosage was also included in the analyses. The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial. P1NP increased less in the Metformin + Insulin compared to the placebo + insulin group (p = 0.001) (between group difference change), while the increases in CTX levels (p = 0.11) were not different. CRP was inversely associated (p = 0.012) and insulin dosage (p = 0.011) was positively related with change in P1NP levels. BMI (p = 0.002) and HbA1C (p = 0.037) were inversely associated with change in CTX levels. During 18 months of treatment with metformin or placebo, both in combination with insulin, bone turnover increased in both groups. But the pattern was different as the bone formation marker (P1NP) increased less during Metformin + Insulin treatment, while change in bone resorption (CTX) was not significantly different between the two groups.",2020,The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial.,"['Patients with Type 2 Diabetes Mellitus', 'type 2 diabetes mellitus (T2DM), randomizing participants to']","['metformin versus placebo both in combination with different insulin analogue regimens (Metformin\u2009+\u2009Insulin vs. Placebo\u2009+\u2009Insulin', 'metformin and insulin', 'Metformin vs. Placebo', 'metformin', 'metformin or placebo', 'Insulin Analogues', 'placebo']","['Bone Markers P1NP and CTX', 'telopeptide of type I collagen (CTX', 'CRP', 'bone formation marker (P1NP', 'CTX levels', 'BMI', 'gender, age, smoking, body mass index (BMI), T2DM duration, glycosylated hemoglobin A1c (HbA1c), c-reactive protein (CRP) and insulin dosage', 'levels of bone formation marker P1NP and bone resorption marker CTX', 'Bone formation and resorption', 'bone resorption (CTX', 'P1NP levels', 'bone turnover']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.227366,The levels of bone formation marker P1NP and bone resorption marker CTX increased significantly in both groups during the trial.,"[{'ForeName': 'Azra Karahasanovic', 'Initials': 'AK', 'LastName': 'Nordklint', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark. azrica87@gmail.com.'}, {'ForeName': 'Thomas Peter', 'Initials': 'TP', 'LastName': 'Almdal', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Departments of Clinical Medicine and Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lundby-Christensen', 'Affiliation': 'Steno Diabetes Center Zealand, Holbæk, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Trine W', 'Initials': 'TW', 'LastName': 'Boesgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Breum', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Birthe', 'Initials': 'B', 'LastName': 'Gade-Rasmussen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simone B', 'Initials': 'SB', 'LastName': 'Sneppen', 'Affiliation': 'Department of Medicine, Gentofte, Copenhagen University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Endocrinology, Bispebjerg, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Perrild', 'Affiliation': 'Department of Endocrinology, Bispebjerg, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Zealand, Holbæk, Denmark.'}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Vestergaard', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Lund', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Eiken', 'Affiliation': 'Department of Nephrology and Endocrinology, Nordsjællands University Hospital, Hillerød, Denmark.'}]",Calcified tissue international,['10.1007/s00223-020-00711-5']
1602,32472628,Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke.,"OBJECTIVE


The objective of this study was to investigate the safety and efficacy of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in the treatment of acute ischemic stroke (AIS).
METHODS


Patients with AIS who underwent IVT were enrolled and 1:1 randomized to the RIC group and sham-RIC group in this study. RIC (or sham-RIC) was performed twice within 6-24 h of IVT. The subjects in the two groups were followed up for 90 days. The safety outcome included the ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24 h after IVT, and laboratory tests 24 h after IVT. The efficacy outcome included the modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP) tested 24 h after IVT.
RESULTS


Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited. No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups. In addition, there was no significant difference in mRS score and NIHSS score during the follow-up between groups. However, patients in the RIC group exhibited a significant lower level of hs-CRP compared with the control group (P = 0.048).
INTERPRETATION


RIC combined with IVT is safe in the treatment of AIS. The neuroprotective and anti-inflammatory effects of this therapy warrant further study on a larger scale.",2020,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","['acute ischemic stroke', 'acute ischemic stroke (AIS', 'Patients with AIS who underwent', 'Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited']","['RIC (or sham-RIC', 'RIC group and sham-RIC', 'IVT', 'remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT', 'Remote ischemic conditioning combined with intravenous thrombolysis']","['ratio of HT, adverse events, blood pressure, coagulation function or liver function', 'mRS score and NIHSS score', 'safety and efficacy', 'modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP', 'level of hs-CRP', 'ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24\xa0h after IVT, and laboratory tests 24\xa0h after IVT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",,0.0585417,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","[{'ForeName': 'Yao-De', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Zhen-Ni', 'Initials': 'ZN', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Reziya', 'Initials': 'R', 'LastName': 'Abuduxukuer', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51063']
1603,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max  of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞  ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max  (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384']
1604,32470635,Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial.,"Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI). Current ablative technologies that modify calcium to optimize stent deployment are limited by guidewire bias and periprocedural complications related to atheroembolization, coronary dissection, and perforation. Intravascular lithotripsy (IVL) delivers pulsatile ultrasonic pressure waves through a fluid-filled balloon into the vessel wall to modify calcium and enhance vessel compliance, reduce fibroelastic recoil, and decrease the need for high-pressure balloon (barotrauma) inflations. IVL has been used in peripheral arteries as stand-alone revascularization or as an adjunct to optimize stent deployment. STUDY DESIGN AND OBJECTIVES: Disrupt CAD III (clinicaltrials.gov identifier: NCT03595176) is a prospective, multicenter, single-arm study designed to assess safety and efficacy of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with de novo calcified coronary stenoses. The primary safety end point is freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization) at 30 days compared to a prespecified performance goal. The primary effectiveness end point is procedural success without in-hospital major adverse cardiovascular events. Enrollment will complete early in 2020 with clinical follow-up ongoing for 2 years. CONCLUSION: Disrupt CAD III will evaluate the safety and effectiveness of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with calcified coronary stenoses.",2020,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"['severely calcified coronary stenoses', 'patients with de novo calcified coronary stenoses', 'patients with calcified coronary stenoses']","['coronary intravascular lithotripsy', 'Intravascular lithotripsy (IVL', 'Shockwave coronary IVL catheter', 'percutaneous coronary intervention (PCI']","['procedural success without in-hospital major adverse cardiovascular events', 'safety and efficacy', 'freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0335608,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital and Lindner Research Center, Cincinnati, OH. Electronic address: Lindner@thechristhospital.com.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hill', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Beaux', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'Shockwave Medical, Santa Clara, CA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.04.005']
1605,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035']
1606,32473355,TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.,"Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.",2020,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","['508 patients are required', 'CKD patients with ACS', 'CKD patients suffering from ACS', 'Patients with stage ≥3b', 'severe or terminal chronic kidney patients Undergoing', 'Chronic kidney disease (CKD', 'severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome', 'stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy']","['ticagrelor and clopidogrel', 'PERcutaneous coronary intervention', 'clopidogrel', 'TicagRelor Or Clopidogrel', 'ticagrelor']","['risk of thrombotic recurrences', 'rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0495371,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: marc.laine@ap-hm.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""Institut Cœur et Poumon, CHRU de Lille, Faculté de Médecine de l'Université de Lille, Unité INSERM UMR 1011, Lille, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Burtey', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France; Service de Néphrologie, Hôpital de la Conception, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Département de Cardiologie, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Département de Cardiologie, CHU Chartres, Chartres, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Quaino', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Canault', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': ""Service de Cardiologie, Centre Hospitalier d'Avignon, Avignon, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}]",American heart journal,['10.1016/j.ahj.2020.04.013']
1607,32473901,Aflibercept Reduces Retinal Hemorrhages and Intravitreal Microvascular Abnormalities But Not Venous Beading: Secondary Analysis of the CLARITY Study.,"PURPOSE


Approximately 50% of patients receiving anti-vascular endothelial growth factor (VEGF) therapy show significant improvement in diabetic retinopathy severity score (DRSS), in particular at DRSS level 47 to 53 (moderately severe to severe nonproliferative diabetic retinopathy). Level 47 to 53 consists of 3 main features: deep hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs). It is unclear whether these features respond to anti-VEGF therapies differently.
DESIGN


Post hoc analysis of Intravitreal Aflibercept versus Panretinal Photocoagulation in Patients with Proliferative Diabetic Retinopathy (CLARITY) study.
PARTICIPANTS


Treatment-naïve participants randomized to intravitreal aflibercept.
METHODS


We reanalyzed the fundus images at baseline, week 12, and week 52 to assess the changes of the 3 main features in DRSS level 47 to 53 in those patients who were treatment naïve and had received aflibercept.
MAIN OUTCOME MEASURES


Changes in DH, VB, and IRMA after aflibercept therapy at weeks 12 and 52.
RESULTS


Fifty-five treatment-naïve eyes at baseline that received aflibercept were included in the study. Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12. From 12 weeks, 32 eyes that had received injections showed improved or stable DH compared with 7 eyes that did not receive injections, and DH deteriorated in 6 eyes with no further injections compared with 4 eyes that had received more injections (P = 0.0072). Similarly, 15 eyes that continued to receive injections from week 12 showed improved or stable IRMA compared with 4 who did not receive injections (P = 0.006). Worsening of IRMA was seen in 5 eyes with no further injections compared with 4 eyes that continued to receive injections. The improvements in DH and IRMA are more likely to be maintained if less than 16 weeks have elapsed since the last anti-VEGF injection.
CONCLUSIONS


Aflibercept seems to improve DH and IRMA after just 3 injections. As soon as the frequency of injections were reduced, DH and IRMA can deteriorate again. It is unclear whether these results can be translated to patients without PDR.",2020,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"['Fifty-five treatment-naïve eyes at baseline that received', 'Patients with Proliferative Diabetic Retinopathy (CLARITY) study', 'patients without PDR']","['anti-vascular endothelial growth factor (VEGF) therapy', 'Panretinal Photocoagulation', 'aflibercept', 'intravitreal aflibercept', 'Aflibercept', 'Intravitreal Aflibercept']","['hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs', 'Severe DH and severe IRMA', 'Worsening of IRMA', 'stable DH', 'Retinal Hemorrhages and Intravitreal Microvascular Abnormalities', 'stable IRMA', 'Changes in DH, VB, and IRMA', 'diabetic retinopathy severity score (DRSS', 'DH and IRMA']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2939143', 'cui_str': 'Retinal veins beaded'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021073', 'cui_str': 'Immunoradiometric Assays'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",6.0,0.0642177,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pearce', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom. Electronic address: liz.pearce@boehringer-ingelheim.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Boehringer Ingelheim International GmBH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.003']
1608,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978']
1609,32474935,Soft tissue healing around platform-switching and platform-matching single implants: A randomized clinical trial.,"BACKGROUND


Implants with platform-switching (PS) design have been demonstrated to reduce marginal bone loss. However, the influence on peri-implant soft tissue healing is unclear. This study was designed to investigate its effect on peri-implant soft tissue healing after implant uncovery.
METHODS


Non-smokers needing two implants in different quadrants were recruited in this study. For each individual, one PS and one platform-matching (PM) implants were placed using two-stage protocol. Following 2 to 8 months of healing, all implants were uncovered and connected to the corresponding healing abutments. Clinical measurements and peri-implant crevicular fluid (PICF) were taken at 1-, 2-, 4-, and 6-week after 2nd stage surgery. The cytokine concentrations in PICF were analyzed. Peri-implant mucosa (1 × 2 × 2 mm) was harvested around the healing abutment for the analysis of gene expression at uncovery and 6-week post-uncovery.
RESULTS


Eighteen participants (nine males; 51.7 ± 14.9 years) were recruited. Compared to PM, PS showed significantly lower probing depth (PD) at 1- and 2-week as well as modified sulcus bleeding index (mSBI) at 1-, 4-, and 6-week (P < 0.05). Over time, a decrease in osteoprotegerin and interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin, and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P < 0.05) without significant intergroup differences.
CONCLUSION


Within the limits, implants with PS design rendered significant benefits over PM design in PD and mSBI reduction during a 6-week healing. However, molecular changes within PICF and peri-implant mucosa as a response to PM and PS appear negligible.",2020,"Over time, a decrease in osteoprotegerin and Interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P<0.05) without significant intergroup differences.
","['18 participants (9 males; 51.7±14.9 years) were recruited', 'Non-smokers needing two implants in different quadrants']","['Soft tissue healing around platform-switching and platform-matching single implants', 'platform-switching (PS']","['modified sulcus bleeding index (mSBI', 'probing depth (PD', 'marginal bone loss', 'receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa', 'osteoprotegerin and Interleukin-1β concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0258286', 'cui_str': 'peroxidasin'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",18.0,0.0499183,"Over time, a decrease in osteoprotegerin and Interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P<0.05) without significant intergroup differences.
","[{'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Cheng', 'Affiliation': 'Graduate Periodontics, Department of Oral Health and Rehabilitation, School of Dentistry, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Binnaz', 'Initials': 'B', 'LastName': 'Leblebicioglu', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Veterinary Biosciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Hua-Hong', 'Initials': 'HH', 'LastName': 'Chien', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0030']
1610,32445440,Remdesivir for the Treatment of Covid-19 - Preliminary Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1611,32456180,"Effectiveness of the ""Mente Sana [Healthy Mind]"" Cognitive Training Program for Older Illiterate Adults with Mild Cognitive Impairment.","Aging can lead to functional and cognitive alterations, sometimes limiting older adults in their social development, especially illiterate groups of older adults who receive poor attention from healthcare systems. In this context, the present investigation proposes the cognitive training program ""MENTE SANA [HEALTHY MIND]"" to improve the cognitive functions of illiterate older adults in Arequipa (Peru). It is a type of quasi-experimental research with a pre-test/post-test design with a homogenous control group. The sample was made up of adults 60 years old and above and of female gender. The Montreal Cognitive Assessment (MoCA) test was used to detect the level of cognitive decline in illiterate older adults. The 50-sessions program was applied to all the older adults with mild cognitive impairment that were selected for the study, on a daily basis. It was found that the tested group improved their cognitive functions compared to the control group. These results help to propose adapted cognitive training programs for illiterate people.",2020,It was found that the tested group improved their cognitive functions compared to the control group.,"['illiterate older adults', 'older adults with mild cognitive impairment', 'illiterate older adults in Arequipa (Peru', 'adults 60 years old and above and of female gender', 'older adults in their social development, especially illiterate groups of older adults who receive poor attention from healthcare systems', 'Older Illiterate Adults with Mild Cognitive Impairment']","['Mente Sana [Healthy Mind', 'Cognitive Training Program']","['cognitive functions', 'Montreal Cognitive Assessment (MoCA) test']","[{'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0075451', 'cui_str': 'succinyl-trialanine-4-nitroanilide'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0106571,It was found that the tested group improved their cognitive functions compared to the control group.,"[{'ForeName': 'Yaneth Del Rosario', 'Initials': 'YDR', 'LastName': 'Palo Villegas', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'Andrea Elena', 'Initials': 'AE', 'LastName': 'Pomareda Vera', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Rojas Zegarra', 'Affiliation': 'Professional School of Psychology, Universidad Nacional de San Agustín de Arequipa, Calle Santa Catalina 117, CP: 04000 Arequipa, Peru.'}, {'ForeName': 'M Dolores', 'Initials': 'MD', 'LastName': 'Calero', 'Affiliation': 'Mind, Brain, and Behavior Research Center, University of Granada, Avenida del Hospicio, CP: 18071 Granada, Spain.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5020034']
1612,32458567,Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial.,"OBJECTIVES


Current WHO guidelines recommend the treatment of all HIV-infected individuals with antiretroviral therapy (ART) to improve survival and quality of life, and decrease infection of others. MaxART is the first implementation trial of this strategy embedded within a government-managed health system, and assesses mortality as a secondary outcome. Because primary findings strongly supported scale-up of the 'treat all' strategy (hereafter Treat All), this analysis examines mortality as an additional indicator of its impact.
METHODS


MaxART was conducted in 14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention. All-cause, disease-related, and HIV-related mortality were analysed using the Cox proportional hazards model, censoring SoC participants at clinic transition. Median follow-up time among study participants was 292 days. There were 36/2034 deaths in SoC (1.77%) and 49/1371 deaths in Treat All (3.57%).
RESULTS


Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and Treat All interventions, respectively, the multivariable-adjusted 12-month all-cause mortality rates were 1.42% [95% confidence interval (CI): 0.66-2.17] and 1.60% (95% CI: 0.78-2.40), disease-related mortality rates were 1.02% (95% CI: 0.40-1.64) and 1.10% (95% CI: 0.46-1.73), and HIV-related mortality rates were 1.03% (95% CI: 0.40-1.65) and 0.99% (95% CI: 0.40-1.58). Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI: 0.52-2.11, P = 0.90), or HIV-related mortality (HR = 0.93, 95% CI: 0.46-1.87, P = 0.83).
CONCLUSION


There was no immediate benefit of the Treat All strategy on mortality, nor evidence of harm. Longer follow-up of participants is needed to establish long-term consequences.",2020,"Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI:","['14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention', 'Between September 2014 and August 2017', 's national standard of care', '3405 participants were enrolled']","['antiretroviral therapy vs. Eswatini', 'MaxART', 'antiretroviral therapy (ART']","['HIV-related mortality', 'mortality rates', 'survival and quality of life', 'disease-related mortality rates', 'Mortality', 'HIV-related mortality rates', 'mortality, nor evidence of harm']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}]",3405.0,0.426961,"Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI:","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Boston, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pasipamire', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chai', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reis', 'Affiliation': 'Leiden University Medical Center, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Delva', 'Affiliation': 'The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Khumalo', 'Affiliation': 'Eswatini National Network of People Living with HIV (SWANNEPHA), Mbabane, Eswatini.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zwane', 'Affiliation': 'SAfAIDS, Manzini, Eswatini.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fleming', 'Affiliation': 'Aidsfonds, Amsterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Eswatini.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Directorate Office, Ministry of Health, Mbabane, Eswatini.'}]",HIV medicine,['10.1111/hiv.12876']
1613,32475705,The risk of developing disordered eating following a family-based program among children with overweight and obesity and their siblings: Retrospective and prospective analyses.,"BACKGROUND


Studies have raised the concern that dieting and weight-loss programs may be a potential risk factor for developing eating disorders, and may have a potential to affect siblings as well. This study assessed the long-term risk of developing disordered eating among children with overweight and obesity and their siblings as well as the change in the obesogenic environment following a family-based intervention program.
METHODS


In a 30-month retrospective follow-up study (n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a multidisciplinary parent-child program called ""Maccabi Active"". Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score were measured.
RESULTS


in the retrospective study, no difference between groups with respect to ChEAT scores in children and siblings was found. In the prospective study, the FEAHQ score significantly decreased after completion of the program (ΔFEAHQ=-16.2±4.9, p=0.001) and continued to decrease in the 8-month follow-up (ΔFEAHQ=-23.2±5.7, p=0.001). BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
CONCLUSIONS


Our findings suggest no exacerbation in disordered eating behaviors among children with overweight or obesity or their siblings, thus alleviating concerns surrounding the development of disordered eating after participating in a family-based intervention. Moreover, improvement in obesogenic environment suggests potential benefits to the entire family.",2020,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
","['n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a', 'children with overweight or obesity or their siblings', 'children with overweight and obesity and their siblings']","['multidisciplinary parent-child program called ""Maccabi Active']","['FEAHQ score', 'BMI z-scores', ""Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score"", 'disordered eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",81.0,0.0161907,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
","[{'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Shaharabany', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel; Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: batya496@gmail.com.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tepper', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: sigalt@bgu.ac.il.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: Berman_s@mac.org.il.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Golan', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: moria.golan@mail.huji.ac.il.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.04.007']
1614,32477208,Training Positive Rumination in Expressive Writing to Enhance Psychological Adjustment and Working Memory Updating for Maladaptive Ruminators.,"Rumination is associated with psychological adjustment and working memory (WM) capacity. Studies have shown that psychological interventions can reduce negative rumination and improve psychological adjustment and WM capacity. The present study investigated the effect of positive rumination training in expressive writing on psychological adjustment and WM updating capacity. Within an experimental design, positive rumination was manipulated for 10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants. Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group. The two groups did not show significant difference of all the variables in pretest. However, the experimental group showed significantly better outcomes than the control group in posttest. The results suggest that positive rumination training in expressive writing is effective and rumination has a causal influence on WM updating capacity.",2020,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,['10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants'],['positive rumination training'],"['psychological adjustment and working memory (WM) capacity', 'psychological adjustment and the response time (RT) of WM updating', 'negative rumination and improve psychological adjustment and WM capacity']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",10.0,0.0192719,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,"[{'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huizhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00789']
1615,32483770,Differential Osteoprotegerin Kinetics after Stimulation with Desmopressin and Lipopolysaccharides In Vivo.,"Osteoprotegerin (OPG) regulates bone metabolism by reducing the activation of osteoclasts, but may also be involved in blood vessel calcification and atherosclerosis. Within endothelial cells OPG is stored in Weibel-Palade bodies (WPBs). Blood kinetics of OPG are essentially unknown. We aimed to assess these using two distinct in vivo models; one after stimulation with desmopressin (DDAVP) and another after stimulation with lipopolysaccharide (LPS). Both clinical trials were conducted at the Department of Clinical Pharmacology at the Medical University of Vienna, Austria. Participants received desmopressin (0.3 µg/kg), LPS (2 ng/kg), or placebo (sodium chloride 0.9%) with subsequent blood sampling at time points up to 24 hours after administration. The primary objective of this study was to investigate the plasma kinetics of OPG after stimulation with desmopressin and LPS. Secondary analyses included the release of other WPB contents including von Willebrand factor (vWF). This analysis included 31 healthy volunteers ( n  = 16 for desmopressin and placebo,  n  = 15 for LPS). Infusion of desmopressin did not increase OPG concentrations compared with placebo, while LPS infusion significantly increased OPG levels, both compared with desmopressin ( p  < 0.0001) and to placebo ( p  = 0.004), with a maximum of ∼twofold increase in OPG levels ∼6 hours after infusion. von Willebrand factor levels increased after both desmopressin and LPS infusion ( p  < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration. In conclusion, we report that, in contrast to vWF, OPG is not released upon stimulation with desmopressin, but increases significantly during experimental endotoxemia.",2020,"von Willebrand factor levels increased after both desmopressin and LPS infusion ( p  < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration.","['  n \u2009=\u200915 for LPS', '31 healthy volunteers ( n \u2009=\u200916 for']","['desmopressin (DDAVP', 'LPS', 'placebo (sodium chloride 0.9%) with subsequent blood sampling', 'Osteoprotegerin (OPG', 'desmopressin and LPS', 'lipopolysaccharide (LPS', 'desmopressin and placebo', 'Desmopressin and Lipopolysaccharides', 'desmopressin', 'placebo']","['OPG levels', 'Blood kinetics of OPG', 'von Willebrand factor levels', 'OPG levels ∼6', 'release of other WPB contents including von Willebrand factor (vWF', 'OPG concentrations', 'plasma kinetics of OPG', 'Differential Osteoprotegerin Kinetics']","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}]","[{'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]",31.0,0.0957707,"von Willebrand factor levels increased after both desmopressin and LPS infusion ( p  < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Buchtele', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katarina D', 'Initials': 'KD', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brostjan', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwameis', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Hayden', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoergenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1712448']
1616,32462992,Predictors of involuntary and voluntary emotional episodic memories of virtual reality scenarios in Veterans with and without PTSD.,"This study investigated predictors of involuntary and voluntary memories of stressful virtual reality scenarios. Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments. They were randomly assigned to a Recounting (16) or a Suppression (16) condition. After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios. One week later, participants completed surprise voluntary memory tests and another thought suppression task. The best predictors of voluntary memory were verbal memory ability, dissociation, and to a lesser extent, physiological arousal before and after scenarios. Dissociation and physiological stress responses selectively affected memory for neutral elements. Higher distress during scenarios impaired voluntary memory but increased the frequency of involuntary memories. Physiological stress responses promoted more frequent involuntary memories immediately after the scenarios. More frequent initial involuntary memories, tonic physiological arousal, and stronger emotional responses to dangerous events predicted difficulty inhibiting involuntary memories at follow-up. The effects of thought suppression were transient and weaker than those of other variables. The findings suggest that posttraumatic amnesia and involuntary memories of adverse events are more related to memory ability and emotional and physiological stress responses than to post-exposure suppression.",2020,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","['Veterans with and without PTSD', 'Thirty-two veterans of the two Persian Gulf Wars completed verbal memory tests and diagnostic assessments']",['surprise voluntary memory tests and another thought suppression task'],"['initial involuntary memories, tonic physiological arousal, and stronger emotional responses', 'frequency of involuntary memories', 'memory ability and emotional and physiological stress responses']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0376439', 'cui_str': 'Persian Gulf'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}]",,0.0230765,"After immersion in the VR scenarios, the Recounting group described the scenarios and the Suppression group suppressed thoughts of the scenarios.","[{'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Szkodny', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Altemus', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Silbersweig', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Weill Medical College of Cornell University, 1300 York Ave, New York, NY 10065.'}]","Memory (Hove, England)",['10.1080/09658211.2020.1770289']
1617,32459637,Evaluating Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation (SAVED Study): Randomized Controlled Trial.,"BACKGROUND


The benefits of telemedicine include cost savings and decentralized care. Video consultation is one form that enables early detection of deteriorating patients and promotion of self-efficacy in patients who are well but anxious. Abdominal pain is a common symptom presented by patients in emergency departments. These patients could benefit from video consultation, as it enables remote follow-up of patients who do not require admission and facilitates early discharge of patients from overcrowded hospitals.
OBJECTIVE


The study aimed to evaluate the safety and efficacy of the use of digital telereview in patients presenting with undifferentiated acute abdominal pain.
METHODS


The SAVED study was a prospective randomized controlled trial in which follow-up using existing telephone-based telereview (control) was compared with digital telereview (intervention). Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat. The control arm received routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff. The intervention arm received access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling. Patients were followed-up for 2 weeks for outcomes of service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition).
RESULTS


A total of 70 patients participated, with patients randomly assigned to each arm (1:1 ratio). Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56%). The telereview service was used by 32 patients in the control arm (32/35, 91%) and 18 patients in the intervention arm (18/35, 51%). Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition. There was a low rate of re-presentation at 72 hours and 2 weeks for both control (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 2/35, 6%, 95% CI 1.0%-20.5%) and intervention (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 3/35, 9%, 95% CI 2.2%-24.2%) arms. There were no significant differences in safety (P>.99) and efficacy (P>.99) between the two groups.
CONCLUSIONS


The application of digital telereview for the follow-up of patients with abdominal pain may be safe and effective. Future studies are needed to evaluate its cost-effectiveness and usefulness for broader clinical application.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN28468556; http://www.isrctn.com/ISRCTN28468556.",2020,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","['strong>Methods</strong', 'CLINICALTRIAL\n\n\nSingHealth Singapore General Hospital (2017/2049', 'patients presenting with undifferentiated acute abdominal pain', 'Patients With Abdominal Pain Using Video Consultation', 'Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56', '70 patients participated', 'Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat']","['existing telephone-based telereview (control', 'digital telereview (intervention', 'digital telereview', 'routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff', 'access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling']","['Safety and Efficacy', 'telereview service', 'safety', 'safety and efficacy', 'low rate of re-presentation', 'Abdominal pain', 'service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition', 'efficacy']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205541', 'cui_str': 'Rescheduled'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",70.0,0.222931,"Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition.","[{'ForeName': 'Dinesh Visva', 'Initials': 'DV', 'LastName': 'Gunasekeran', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Win Jim', 'Initials': 'WJ', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chiu Peng', 'Initials': 'CP', 'LastName': 'Cheong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Lay Hong', 'Initials': 'LH', 'LastName': 'Tan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Chee Siang', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gaik Kheng', 'Initials': 'GK', 'LastName': 'Phuah', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Newsie Donnah A', 'Initials': 'NDA', 'LastName': 'Manuel', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Che Chong', 'Initials': 'CC', 'LastName': 'Chia', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Gek Siang', 'Initials': 'GS', 'LastName': 'Seng', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'May Hang', 'Initials': 'MH', 'LastName': 'Huin', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Suzette Villaluna', 'Initials': 'SV', 'LastName': 'Dulce', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Yap', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Kishanti', 'Initials': 'K', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': 'Health Services Research Center, Singhealth Services, Singapore, Singapore.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ponampalam', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/17417']
1618,32459639,"Achieving Optimal Gestational Weight Gain, Birth Weight, and Perinatal Outcomes Among Pregnant Women at Risk of Hypertension: Protocol for a Pilot Randomized Controlled Trial.","BACKGROUND


Hypertensive disorders, including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive disorders. Conventional antenatal care practices often delay or miss detecting hypertensive disorders in pregnancy, which may allow some women to become vulnerable to the adverse consequences of the hypertensive disorders. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; however, to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined.
OBJECTIVE


The objectives of this study are to evaluate the accuracy of a wearable blood pressure monitoring device (Health Gauge) in order to test the design and methods of a future definitive randomized controlled trial, and to examine the feasibility, acceptability, and fidelity of an intervention focusing on regular monitoring of weight gain and self-monitoring of blood pressure for pregnant women at risk of developing hypertensive disorders and their associated complications.
METHODS


The study is located in Matlab, Bangladesh will be conducted in two phases. First, a wearable blood pressure device (Health Gauge) will be validated in accordance with the European Society of Hypertension International Protocol (revision 2010). Second, a prospective, two-arm, parallel, and nonblinded randomized controlled external pilot trial will be conducted. In the pilot trial, 70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment). All women will receive standard antenatal care.
RESULTS


A validation study of the wearable blood pressure device has successfully been conducted among the general adult population in Matlab, Bangladesh. As of September 2019, the pilot trial has completed enrollment of women who are pregnant (N=70; intervention: n=35; control: n=35) and follow-up of the participants is ongoing. Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020.
CONCLUSIONS


The findings of this study will help us to design a comprehensive, full-scale randomized controlled trial to test the efficacy of regular self-monitoring of blood pressure and weight gain during pregnancy, a simple and inexpensive intervention to help to achieve optimal maternal and fetal outcomes in pregnant women at risk of developing hypertensive disorders and their associated complications during pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16676.",2020,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","['pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management', 'pregnant women at risk of developing HDP or their complications', 'Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure', 'general adult population in Matlab', 'two phases in Matlab, Bangladesh: 1) validation of HG according to the European Society of Hypertension International Protocol revision 2010, and 2', '70 eligible participants']","['pregnant women will self-monitor their BP daily using a wearable device (HG) and be evaluated for weight gain monthly from 20 weeks of gestation until delivery or the control arm', 'Conventional antenatal care (ANC) practices', 'Regular self-monitoring of blood pressure (BP) and weight gain', 'wearable BP measuring device (Health Gauge [HG']","['weight gain', 'Optimizing Gestational Weight Gain, Birth Weight and Perinatal Outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.125868,"Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management.","[{'ForeName': 'S M Tafsir', 'Initials': 'SMT', 'LastName': 'Hasan', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Syed Imran', 'Initials': 'SI', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Md Alfazal', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Shafiqul Alam', 'Initials': 'SA', 'LastName': 'Sarker', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}]",JMIR research protocols,['10.2196/16676']
1619,32460459,Effectiveness of nivolumab versus regorafenib in hepatocellular carcinoma patients who failed sorafenib treatment.,"BACKGROUND/AIMS


Several treatment options are currently available for patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment. We aimed to compare the effectiveness of regorafenib and nivolumab in these patients.
METHODS


Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included. Primary endpoint was overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events. Inverse probability of treatment weighting (IPTW) using the propensity score was conducted to reduce treatment selection bias.
RESULTS


Among 150 study patients, 102 patients received regorafenib and 48 patients received nivolumab. Median OS was 6.9 (95% confidence interval [CI], 3.0-10.8) months for regorafenib and 5.9 (95% CI, 3.7-8.1) months for nivolumab (P=0.77 by log-rank test). In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04). Time to progression was not significantly different between groups (nivolumab vs. regorafenib: aHR, 0.82; 95% CI, 0.51-1.30; P=0.48). HRs were maintained after IPTW. Objective response rates were 5.9% and 16.7% in patients treated with regorafenib and nivolumab, respectively (P=0.04).
CONCLUSION


After sorafenib failure, the use of nivolumab may be associated with improved OS and better objective response rate as compared to using regorafenib.",2020,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","['150 study patients', 'Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included', 'patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment', '102 patients received', 'hepatocellular carcinoma patients who failed sorafenib treatment']","['nivolumab versus regorafenib', 'regorafenib', 'nivolumab', 'regorafenib and nivolumab']","['overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events', 'Median OS', 'Objective response rates', 'Time to progression', 'OS and better objective response rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",150.0,0.318331,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","[{'ForeName': 'Cheol-Hyung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minseok Albert', 'Initials': 'MA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0049n']
1620,32460460,Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response.,"BACKGROUND/AIMS


Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV.
METHODS


This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded.
RESULTS


Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events.
CONCLUSION


ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).",2020,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"['patients with LAM-resistant hepatitis B virus (HBV) infections', '91 patients whose', 'chronic hepatitis B patients with prior suboptimal response', 'Patients with baseline ADV resistance were excluded']","['lamivudine or telbivudine plus adefovir (LAM/LdT+ADV', 'Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir', 'LAM/LdT+ADV', 'entecavir plus tenofovir (ETV+TDF', 'ETV+TDF', 'new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV']","['rate of virologic response', 'high baseline HBV DNA level', 'rates of adverse events', 'virologic response', 'serum HBV DNA level', 'serum HBV DNA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C1453933', 'cui_str': 'telbivudine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]",91.0,0.051612,Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response.,"[{'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Jun Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Si Hyun', 'Initials': 'SH', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Tak', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Chonju, Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0044n']
1621,32468087,Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.,"PURPOSE


Nangibotide is a specific TREM-1 inhibitor that tempered deleterious host-pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.
METHODS


This was a multicenter randomized, double-blind, two-stage study. Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days. Safety primary outcomes were adverse events (AEs), whether serious or not, and death. Exploratory endpoints evaluated nangibotide effects on pharmacodynamics, organ function, and mortality, and were analyzed according to baseline sTREM-1 concentrations.
RESULTS


Forty-nine patients were randomized. All treatment emergent AEs (TEAEs) were collected until Day 28. No significant differences were observed in TEAEs between treatment groups. No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported. Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent. Nangibotide did not significantly affect pharmacodynamic markers. Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant). This pattern was similar to organ support end points.
CONCLUSION


No significant increases in TEAEs were detected in nangibotide-treated patients versus placebo. These results encourage further evaluation of nangibotide and further exploration of plasma sTREM-1 concentrations as a predictive efficacy biomarker.",2020,No significant differences were observed in TEAEs between treatment groups.,"['septic shock patients', 'patients with septic shock', 'Forty-nine patients were randomized']","['Nangibotide', 'continuous infusion of nangibotide', 'placebo']","['Nangibotide pharmacokinetics', 'nangibotide effects on pharmacodynamics, organ function, and mortality', 'TEAEs', 'pharmacodynamic markers', 'SOFA score LS mean change (±\u2009SE', 'adverse events (AEs), whether serious or not, and death']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",49.0,0.585864,No significant differences were observed in TEAEs between treatment groups.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical ICU Department and Inserm CIC1435 & UMR1092, CRICS-TRIGGERSEP Network, CHU Limoges, Limoges, France. b.francois@unilim.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""ICU Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Medical ICU, Cochin Hotel-Dieu, AP-HP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'ICU Department, Clinique St. Pierre, Ottignies, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Gibot', 'Affiliation': 'Medical ICU Department, Hospital Central, CHU Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Derive', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Olivier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Cuvier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Witte', 'Affiliation': 'Helion Pharma, Schriesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'ICU Department, Radboudumc Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vandenhende', 'Affiliation': 'ClinBay SPRL, Baisy-Thy, Belgium.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Garaud', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'ICU Department, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Salcedo-Magguilli', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}]",Intensive care medicine,['10.1007/s00134-020-06109-z']
1622,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002']
1623,32472611,Novel dose escalation to predict treatment with hydroxyurea (NDEPTH): A randomized controlled trial of a dose-prediction equation to determine maximum tolerated dose of hydroxyurea in pediatric sickle cell disease.,,2020,,['Pediatric Sickle Cell Disease'],"['Hydroxyurea (NDEPTH', 'Hydroxyurea']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]",[],,0.125772,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'George', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Dinu', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Estrada', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Mahoney', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Yates', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Alaundra', 'Initials': 'A', 'LastName': 'Carmouche', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Gladstone', 'Initials': 'G', 'LastName': 'Airewele', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirk', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Titilope', 'Initials': 'T', 'LastName': 'Fasipe', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Uwaezuoke', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",American journal of hematology,['10.1002/ajh.25883']
1624,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND


Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation.
OBJECTIVE


This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019.
METHODS


We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019.
RESULTS


Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P = .0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group.
CONCLUSIONS


Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: Gang.Huang@cchmc.org.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019']
1625,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND


In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion.
OBJECTIVES


The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population.
METHODS


A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline.
RESULTS


During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters.
CONCLUSION


These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983']
1626,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
1627,32474204,Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China.,"BACKGROUND


Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China.
METHODS


To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181 CONCLUSIONS: The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.",2020,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","['hospitalized patients using a', '5760 hospitalized patients in 32 hospitals on mainland China', 'hospitalized patients in China']","['system-wide multifaceted quality improvement intervention', 'hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education', 'system-wide multifaceted quality improvement (QI) strategy', 'RCT']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]",[],5760.0,0.127351,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Zhen', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chaozeng', 'Initials': 'C', 'LastName': 'Si', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiefeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Tieshan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Medical Affairs Department of China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Cunbo', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Shan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China. Electronic address: zhaizhenguo2011@126.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.020']
1628,32474206,"The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation.","BACKGROUND


Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need.
METHODS


The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD.
CONCLUSION


INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.",2020,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"['pregnant women with RHD', 'patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2', 'rheumatic valvular disease and atrial fibrillation', '17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years', 'patients with valvular AF', 'enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America', 'Patients with RHD and AF', 'patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry', '4500 patients comparing']","['rivaroxaban with vitamin K antagonists (VKA', 'vitamin K antagonists', 'VKAs, rivaroxaban or aspirin', 'rivaroxaban', 'VKA']",['composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0264757', 'cui_str': 'Rheumatic disease of heart valve'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517780', 'cui_str': '4500'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",4565.0,0.080112,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"[{'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India. Electronic address: karthik2010@gmail.com.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yun', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Fathi', 'Initials': 'F', 'LastName': 'Maklady', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Elghamrawy', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Khawar', 'Initials': 'K', 'LastName': 'Kazmi', 'Affiliation': 'Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Tantchou T J', 'Initials': 'TTJ', 'LastName': 'Cabral', 'Affiliation': 'St. Elizabeth Catholic General Hospital, Cameroon.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Dayi', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Changsheng', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Gitura', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paolo, Brazil.'}, {'ForeName': 'Liesl', 'Initials': 'L', 'LastName': 'Zuhlke', 'Affiliation': 'Red Cross War Memorial Childrens Hospital, Cape Town, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lwabi', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Haileamlak', 'Affiliation': 'Jimma University Hospital, Ethiopia.'}, {'ForeName': 'Okechukwu', 'Initials': 'O', 'LastName': 'Ogah', 'Affiliation': 'University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Pilly', 'Initials': 'P', 'LastName': 'Chillo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paniagua', 'Affiliation': 'Barrio Obrero Hospital Asunción, Paraguay.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'ElSayed', 'Affiliation': 'Alzaeim Alazhari University, Khartoum, Sudan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Philippines General Hospital, Manila, Philippines.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Gondwe-Chunda', 'Affiliation': 'Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Onkabetse Julia', 'Initials': 'OJ', 'LastName': 'Molefe-Baikai', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Jesus A', 'Initials': 'JA', 'LastName': 'Gonzalez-Hermosillo', 'Affiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Maputo Central Hospital, Maputo, Mozambique.'}, {'ForeName': 'Emmanuel R', 'Initials': 'ER', 'LastName': 'Kamanzi', 'Affiliation': 'University Teaching Hospital of Kigali, Rwanda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Musuku', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Kairat', 'Initials': 'K', 'LastName': 'Davletov', 'Affiliation': 'Al-Farabi Kazakh National University, Almaty, Kazakhstan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Bongani M', 'Initials': 'BM', 'LastName': 'Mayosi', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.03.018']
1629,32480417,von Willebrand Factor and Factor VIII Clearance in Perioperative Hemophilia A Patients.,"BACKGROUND


von Willebrand factor (VWF) is crucial for optimal dosing of factor VIII (FVIII) concentrate in hemophilia A patients as it protects FVIII from premature clearance. To date, it is unknown how VWF behaves and what its impact is on FVIII clearance in the perioperative setting.
AIM


To investigate VWF kinetics (VWF antigen [VWF:Ag]), VWF glycoprotein Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp) in severe and moderate perioperative hemophilia A patients included in the randomized controlled perioperative OPTI-CLOT trial.
METHODS


Linear mixed effects modeling was applied to analyze VWF kinetics. One-way and two-way analyses of variance were used to investigate perioperative VWFpp/VWF:Ag ratios and associations with surgical bleeding.
RESULTS


Fifty-nine patients with median age of 48.8 years (interquartile range: 34.8-60.0) were included. VWF:Ag and VWF:GPIbM increased significantly postoperatively. Blood type non-O or medium risk surgery were associated with higher VWF:Ag and VWF:GPIbM levels compared with blood type O and low risk surgery. VWFpp/VWF:Ag was significantly higher immediately after surgery than 32 to 57 hours after surgery ( p  < 0.001). Lowest VWF:Ag quartile (0.43-0.92 IU/mL) was associated with an increase of FVIII concentrate clearance of 26 mL/h (95% confidence interval: 2-50 mL/h) compared with highest VWF antigen quartile (1.70-3.84 IU/mL). VWF levels were not associated with perioperative bleeding  F (4,227) = 0.54,  p  = 0.710.
CONCLUSION


VWF:Ag and VWF:GPIbM levels increase postoperatively, most significantly in patients with blood type non-O or medium risk surgery. Lower VWF antigen levels did not lead to clinically relevant higher FVIII clearance. VWF:Ag or VWF:GPIbM levels were not associated with perioperative hemorrhage.",2020,"VWF levels were not associated with perioperative bleeding  F (4,227) = 0.54,  p  = 0.710.
","['Fifty-nine patients with median age of 48.8 years (interquartile range: 34.8-60.0) were included', 'Perioperative Hemophilia A Patients', 'severe and moderate perioperative hemophilia', 'patients with blood type non-O or medium risk surgery', 'hemophilia']","['Blood type non-O or medium risk surgery', 'VWFpp/VWF', 'VWF', 'Ag or VWF', 'VWF glycoprotein', 'factor VIII ', 'Ag and VWF', 'Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp', 'Lowest VWF']","['FVIII concentrate clearance', 'VWF kinetics (VWF antigen ', 'Lower VWF antigen levels', 'VWF levels', 'von Willebrand Factor and Factor VIII Clearance', 'GPIbM levels', 'GPIbM']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1318684', 'cui_str': 'von Willebrand factor antigen level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",59.0,0.0316008,"VWF levels were not associated with perioperative bleeding  F (4,227) = 0.54,  p  = 0.710.
","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van Moort', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Bukkems', 'Affiliation': 'Department of Clinical Pharmacology - Hospital Pharmacy, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Heijdra', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Roger E G', 'Initials': 'REG', 'LastName': 'Schutgens', 'Affiliation': 'Van Creveldkliniek, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Britta A P', 'Initials': 'BAP', 'LastName': 'Laros-van Gorkom', 'Affiliation': 'Department of Thrombosis and Hemostasis, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Nieuwenhuizen', 'Affiliation': 'Department of Internal Medicine, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Felix J M', 'Initials': 'FJM', 'LastName': 'van der Meer', 'Affiliation': 'Division of Thrombosis and Hemostasis, Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Fijnvandraat', 'Affiliation': 'Department of Pediatric Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Moniek P M', 'Initials': 'MPM', 'LastName': 'de Maat', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank W G', 'Initials': 'FWG', 'LastName': 'Leebeek', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Eikenboom', 'Affiliation': 'Division of Thrombosis and Hemostasis, Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Department of Clinical Pharmacology - Hospital Pharmacy, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjon H', 'Initials': 'MH', 'LastName': 'Cnossen', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thrombosis and haemostasis,['10.1055/s-0040-1710591']
1630,32464435,Comparison of parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome: A randomized clinical trial.,"OBJECTIVE


To compare the effects of parasacral transcutaneous electrical stimulation with the effects of transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome (OAB).
STUDYDESIGN


A randomized clinical trial was performed with 50 women aged 40-76 years with symptoms of OAB, divided into two groups: the parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group. Both groups underwent the same protocol, at home, for 6 weeks, applying electrical stimulation three times per week. The tools used for evaluation were the King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI). Statistical analysis was undertaken using independent t-test, Mann-Whitney test, Chi-squared test and generalized estimating equations.
RESULTS


After 6 weeks of treatment, OAB-V8 showed a significant improvement in the PTN group compared with the PS group (Mann-Whitney test, p = 0.019). Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI. All variables showed a significant effect of time after 6 weeks of treatment for both groups (p < 0.005).
CONCLUSION


Both forms of transcutaneous electrical stimulation seem to be effective and safe for home treatment of women with OAB.",2020,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","['women with overactive bladder syndrome (OAB', 'women with overactive bladder syndrome', '50 women aged 40-76 years with symptoms of OAB', 'women with OAB']","['transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation', 'transcutaneous posterior tibial nerve stimulation', 'parasacral transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group']","[""King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI"", 'KHQ domains, average KHQ symptom scale and proportions of categories of ISI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.0432647,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","[{'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Mallmann', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: suzana_mallmann@hotmail.com.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Ferla', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marina P', 'Initials': 'MP', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luciana L', 'Initials': 'LL', 'LastName': 'Paiva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Paulo R S', 'Initials': 'PRS', 'LastName': 'Sanches', 'Affiliation': 'Research and Development Service in Biomedical Engineering, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'José Geraldo L', 'Initials': 'JGL', 'LastName': 'Ramos', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.005']
1631,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1632,32472792,Clinical Efficacy of Immediate Manual Meibomian Gland Expression After Thermal Pulsation (LipiFlow) for Obstructive Meibomian Gland Dysfunction: Comparison With Thermal Pulsation.,"PURPOSE


To evaluate the clinical efficacy and safety of immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC) for obstructive meibomian gland dysfunction and to compare the LipiFlow only and MGX after LipiFlow.
METHODS


Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included. Thirty eyes from 15 patients were enrolled in each group. All patients underwent 3 treatments at monthly intervals. All patients were followed up for 6 months after treatment. All patients were examined before and at 3 and 6 months after treatment. Examinations included the Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height.
RESULTS


The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001). In the LipiFlow-only group, the NIBUT and LLT significantly improved at 3 months (P < 0.001 and P = 0.006) but deteriorated at 6 months. In the MGX after LipiFlow group, the NIBUT and LLT improved at 3 months (P < 0.001 and P < 0.001), and this improvement was maintained at 6 months. The improvement of NIBUT at 3 months was greater in the MGX after LipiFlow group (3.24 ± 1.16 to 9.25 ± 1.36 s) than in the LipiFlow-only group (3.78 ± 1.75 to 7.18 ± 2.70 s), and the improvements of the LLT at 6 months were greater in the MGX after LipiFlow group (30.27 ± 10.74 to 46.93 ± 20.81 μm) than in the LipiFlow-only group (34.70 ± 10.79 to 38.73 ± 14.70 μm).
CONCLUSIONS


Both LipiFlow only and MGX after LipiFlow were clinically effective for obstructive meibomian gland dysfunction. However, the efficacy and persistence of treatment were greater in patients who received MGX after LipiFlow.",2020,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"['Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included', 'Thirty eyes from 15 patients were enrolled in each group', 'Obstructive Meibomian Gland Dysfunction']","['Immediate Manual Meibomian Gland Expression', 'Thermal Pulsation (LipiFlow', 'immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC']","['Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height', 'Ocular Surface Disease Index scores', 'NIBUT and LLT', 'improvement of NIBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}]",30.0,0.0233914,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"[{'ForeName': 'Hye Jee', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Miso Eye Clinic, Gyeonggi-do, Republic of Korea.'}]",Cornea,['10.1097/ICO.0000000000002328']
1633,32470421,"Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.","BACKGROUND


Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
METHODS


This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
FINDINGS


Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
INTERPRETATION


This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
FUNDING


Boston Scientific.",2020,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","['313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned', '23 implanting centres in the USA', ""patients with Parkinson's disease"", ""motor symptoms of Parkinson's disease"", '160 patients included in the interim analysis, 121 (76', 'Between May 17, 2013, and Nov 30, 2017', '313 patients were enrolled across 23 sites', ""Parkinson's disease (INTREPID"", ""Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent""]","['subthalamic nucleus DBS with a novel MICC device', 'Subthalamic nucleus deep brain stimulation', 'Deep brain stimulation (DBS', 'active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group', 'novel multiple independent contact current-controlled (MICC) device']","['ON time without troublesome dyskinesias', 'anti-parkinsonian medications', 'mean number of waking hours per day with good symptom control and no troublesome dyskinesias', '26 serious adverse events', 'mean change from baseline visit to 3 months post-randomisation']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",313.0,0.575314,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","[{'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Vitek', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Tröster', 'Affiliation': 'Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schrock', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'House', 'Affiliation': 'Neurosurgical Associates, Murray, UT, USA.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'Giroux', 'Affiliation': 'Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Hebb', 'Affiliation': 'Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sierra M', 'Initials': 'SM', 'LastName': 'Farris', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Whiting', 'Affiliation': 'Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Leichliter', 'Affiliation': 'Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Ostrem', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Luciano', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Tatter', 'Affiliation': 'Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ihtsham', 'Initials': 'I', 'LastName': 'Ul Haq', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gostkowski', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tagliati', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Adam N', 'Initials': 'AN', 'LastName': 'Mamelak', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Moguel-Cobos', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Ponce', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jules M', 'Initials': 'JM', 'LastName': 'Nazzaro', 'Affiliation': 'Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cathrin M', 'Initials': 'CM', 'LastName': 'Buetefisch', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gross', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Corneliu C', 'Initials': 'CC', 'LastName': 'Luca', 'Affiliation': 'Department of Neurology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Jagid', 'Affiliation': 'Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Revuelta', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Takacs', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pourfar', 'Affiliation': 'Department of Neurology, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Alon Y', 'Initials': 'AY', 'LastName': 'Mogilner', 'Affiliation': 'Department of Neurosurgery, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Mandybur', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Cooper', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Suketu M', 'Initials': 'SM', 'LastName': 'Khandhar', 'Affiliation': 'Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sedrak', 'Affiliation': 'Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Pilitsis', 'Affiliation': 'Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Uitti', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Starr', 'Affiliation': 'Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30108-3']
1634,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
1635,32473356,Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.,"BACKGROUND


Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12  receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
METHODS


Assessment of Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
CONCLUSION


ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.",2020,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"['patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290', 'patients with stable coronary artery disease who are planned for an elective PCI', '1,900 patients', 'patients undergoing elective percutaneous coronary intervention (PCI']","['Loading with the P2Y 12  inhibitor ticagrelor or clopidogrel', 'ticagrelor 180 mg or a loading dose of clopidogrel', 'aspirin', 'aspirin and ticagrelor 90 mg twice daily or clopidogrel']","['PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier', 'periprocedural ischemic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1900.0,0.0455808,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen-Département de Cardiologie; Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'CH de Chartres-Département de Cardiologie, Chartes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Department of Cardiology, Inserm U942, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'CH de Bastia-Département de Cardiologie, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion-Département de Cardiologie, La Réunion, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'CHU de Poitiers-Service de Cardiologie, Poitiers, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'CHU de Toulouse-Département de Cardiologie, Toulouse, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Georges', 'Affiliation': 'CH de Versailles-Service de Cardiologie, Hôpital A. Mignot, Le Chesnay, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellemain-Appaix', 'Affiliation': ""CH d'Antibes Juan-Les-Pins-Département de Cardiologie, Antibes Juan-Les-Pins, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Univ Rennes, CHU Rennes, Inserm LTSI U1099, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'CHU Ambroise Paré (APHP), Université Versailles-Saint Quentin, ACTION study Group, INSERM-U1018 CESP, Boulogne, France-Service de Cardiologie.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'CHU Trousseau, Tours-Département de Cardiologie, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste Montsouris-Département de Cardiologie, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jourda', 'Affiliation': 'CH Auxerre-Département de Cardiologie, Auxerre, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': '3rd Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Grand Hôpital de l'Est Francilien site Marne-La-Vallée - Département de Cardiologie, Marne La Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation center, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), DHU FIRE, Hôpital Bichat, AP-HP, Université de Paris, Inserm U-1148, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), Paris, France; SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.017']
1636,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE


Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential.
MATERIALS AND METHODS


MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied.
RESULTS


Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05.
CONCLUSIONS


Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996']
1637,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
1638,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
1639,32474473,Supplementation with Matured Hop Bitter Acids Improves Cognitive Performance and Mood State in Healthy Older Adults with Subjective Cognitive Decline.,"BACKGROUND


Prevention of age-related cognitive decline and depression is becoming urgent because of rapid growing aging populations. Effects of vagal nerve activation on brain function by food ingredients are inadequately investigated; matured hop bitter acid (MHBA) administration reportedly improves cognitive function and depression via vagal nerve activation in model mice.
OBJECTIVE


We investigated the effects of MHBA supplementation on cognitive function and mood state in healthy older adults with perceived subjective cognitive decline.
METHODS


Using a randomized double-blind placebo-controlled trial design, 100 subjects (aged 45-69 years) were randomly assigned into placebo (n = 50) and MHBA (n = 50) groups, and received placebo or MHBA capsules daily for 12 weeks.
RESULTS


Symbol Digit Modalities Test (SDMT) score assessing divided attention at week 12 was significantly higher (p = 0.045) and β-endorphin at week 12 was significantly lower (p = 0.043) in the subjects receiving MHBA. Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048). Subgroup analysis classified by the subjective cognitive decline questionnaire revealed that in addition to improved SDMT scores, memory retrieval assessed using the standard verbal paired-associate learning tests and the Ray Verbal Learning Test at week 12 had significantly improved in the subgroup with perceived subjective cognitive decline and without requirement for medical assistance in the MHBA group compared with that in the placebo group.
CONCLUSION


This study suggested that MHBA intake improves cognitive function, attention, and mood state in older adults.",2020,"Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048).","['100 subjects (aged 45-69 years', 'older adults', 'healthy older adults with perceived subjective cognitive decline', 'Healthy Older Adults with Subjective Cognitive Decline']","['vagal nerve activation', 'MHBA supplementation', 'placebo or MHBA capsules daily for 12 weeks', 'Supplementation with Matured Hop Bitter Acids', 'MHBA', 'placebo']","['Symbol Digit Modalities Test (SDMT) score assessing divided attention', 'SDMT scores, memory retrieval assessed using the standard verbal paired-associate learning tests and the Ray Verbal Learning Test', 'cognitive function, attention, and mood state', 'subjective cognitive decline and without requirement for medical assistance', 'cognitive function and mood state', 'Transthyretin in serum, a putative mild cognitive impairment marker', 'Cognitive Performance and Mood State', 'β-endorphin']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0025070', 'cui_str': 'Assistance, Medical'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}]",100.0,0.48803,"Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048).","[{'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ohnuma', 'Affiliation': 'Department of Psychiatry, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Obara', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Fukushima Healthcare Center, Osaka, Japan.'}, {'ForeName': 'Heii', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Department of Psychiatry, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Ano', 'Affiliation': 'KIRIN Central Research Institute, Kirin Holdings Company, Ltd., Kanagawa, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200229']
1640,32474683,The use of whole-body cryotherapy: time- and dose-response investigation on circulating blood catecholamines and heart rate variability.,"PURPOSE


A predominance of parasympathetic drive is observed following cold exposure. Such modulation of the autonomic nervous system (ANS) is associated with faster post-exercise recovery. Within this context, whole-body cryotherapy (WBC) has been spreading in sport medicine, though the optimal temperature and frequency are unclear. The aim of this study was to examine the effects of different cryotherapy conditions on the sympathovagal balance.
METHODS


Forty healthy males were randomly assigned into five different groups (- 110 °C, - 60 °C, - 10 °C, control temperature [≃ 24 °C]) and undertook 5 WBC sessions over 5 consecutive days. Cardiac autonomic activity was assessed through heart rate variability (HRV) using power density of high frequency (HF), root-mean square difference of successive R-R intervals (RMSSD) and sympathovagal balance (LF/HF). Systemic sympathetic activity was assessed via circulating blood catecholamines.
RESULTS


Mean weekly RMSSD (pre: 48 ± 22 ms, post: 68 ± 29 ms) and HF (pre: 607 ± 692 ms 2 , post: 1271 ± 1180 ms 2 ) increased (p < 0.05) from pre to post WBC, only in the - 110 °C condition. A rise in plasma norepinephrine was found after the first - 110 °C WBC session only (pre: 173 ± 98, post: 352 ± 231 ng L -1 , p < 0.01); whereas, it was not significant after the 5th session (pre: 161 ± 120, post: 293 ± 245 ng L -1 , p = 0.15).
CONCLUSION


These results suggest that one - 110 °C WBC exposure is required to stimulate the ANS. After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.",2020,"After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.",['Forty healthy males'],['whole-body cryotherapy (WBC'],"['heart rate variability (HRV) using power density of high frequency (HF), root-mean square difference of successive R-R intervals (RMSSD) and sympathovagal balance (LF/HF', 'Cardiac autonomic activity', 'autonomic response', 'circulating blood catecholamines and heart rate variability', 'Systemic sympathetic activity', 'plasma norepinephrine']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0440738', 'cui_str': 'Circulating blood'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]",40.0,0.0263788,"After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Louis', 'Affiliation': 'Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK. J.B.Louis@ljmu.ac.uk.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Theurot', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Robert', 'Initials': 'JR', 'LastName': 'Filliard', 'Affiliation': 'Medical Department, French Institute of Sport (INSEP), 11 avenue du tremblay, 75012, Paris, France.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Volondat', 'Affiliation': 'Medical Department, French Institute of Sport (INSEP), 11 avenue du tremblay, 75012, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dugué', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}]",European journal of applied physiology,['10.1007/s00421-020-04406-5']
1641,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE


Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association.
METHOD


As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data.
RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women.
CONCLUSIONS


Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474']
1642,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE


To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels.
METHODS


The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141.
RESULTS


The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
CONCLUSIONS


Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162']
1643,32583727,Effects of an aerobic fitness test on short- and long-term memory in elementary-aged children.,"Meta-analytic evidence supports that exercise has benefits for short-term memory (STM) and long-term memory (LTM). However, only three studies with children have tested the differential effects of exercise on STM and LTM. The purpose of this study was to examine the effects of an aerobic fitness test on STM and LTM and to consider the moderating effects of grade level. Children (7-13 years of age) were randomly assigned to either perform an aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT) to assess memory. Memory was tested again after approximately 24 hours. There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders. For learning, Day 1 Retention, 24-hr recall, and Day 2 Retention, the exercise prior group performed better than the exercise post group. It is concluded that an aerobic fitness test performed prior to a declarative memory test benefits LTM as compared to when the aerobic fitness test is performed after the memory test.",2020,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"['Children (7-13\xa0years of age', 'elementary-aged children']","['aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT', 'aerobic fitness test']","['short- and long-term memory', 'memory performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.031325,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sprick', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Chia-Hao', 'Initials': 'CH', 'LastName': 'Shih', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Glass', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jarod C', 'Initials': 'JC', 'LastName': 'Vance', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1778251']
1644,32580752,Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial.,"BACKGROUND


Currently, coronavirus disease 2019 (COVID-19) is continuously and rapidly circulating, causing heavy damage on public health. No effective antiviral treatment has been proved thus far. Traditional Chinese medicine (TCM) has been widely applied in the treatment of a variety of infection diseases in China, hoping to produce clinical effects and reduce the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Shenhuang granule in treatment of severe COVID-19.
METHODS/DESIGN


This multicenter, open-label randomized controlled trial is conducted in 160 participants with severe COVID-19. The participants will be randomly (1:1) divided into treatment group or control group. All participants are given standard therapy at the same time. The experiment will receive Shenhuang granule treatment twice a day for 14 days. The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation. The primary outcome is 14-day clinical outcome. Adverse events will be monitored throughout the trial.
DISCUSSION


This will be the first randomized controlled trial, which evaluate the effect of Shenhuang granule in patients with severe COVID-19 in China. The results of this trial may not only provide evidence-based recommendations to clinicians to treat severe COVID-19, but also enrich the theory and practice of TCM in treating infectious diseases.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000029777. Registered on 13 February 2020.",2020,"The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation.","['patients with severe COVID-19 in China', '160 participants with severe COVID-19']",['Traditional Chinese medicine (TCM'],"['efficacy and safety', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",160.0,0.157219,"The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation.","[{'ForeName': 'Bangjiang', 'Initials': 'B', 'LastName': 'Fang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Tingrong', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'Huacheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, Huangshi, 435000, Hubei, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Che', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Clinical Medical College of TCM, Hubei University of Chinese Medicine, NO.1 Tanhualin, Wuchang District, Wuhan, 430065, Hubei, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""The Third Department of Neurology, The Second Affiliated Hospital of Xi'an Medical University, NO.167, Textile City East Street, Baqiao District, Xi'an, 710032, Shanxi, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai, 201203, China. zhoushuang8008@163.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Emergency Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1095 Jie Fang Avenue, Hankou, Wuhan, 430030, Hubei, China. andyterry555@163.com.'}]",Trials,['10.1186/s13063-020-04498-6']
1645,32585833,Self-Reported Versus Observed Measures: Validation of Child Caregiver Food Hygiene Practices in Rural Malawi.,"Few studies have attempted to measure the differences between self-reported and observed food hygiene practices in a household setting. We conducted a study to measure the level of agreement between self-reported and observed food hygiene practices among child caregivers with children under the age of five years in rural Malawi. Fifty-eight child caregivers from an intervention and 29 from a control group were recruited into the study. At the end of a nine-month food hygiene intervention, household observations were conducted followed by self-reported surveys. Overall, practices were found to be more frequently reported than observed in both groups. However, the difference between self-reports and observed practices was minimal in the intervention compared to the control group. The odds ratio results confirm that more desirable practices were observed in the intervention group compared to the control group. Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice. Researchers and implementing agencies in water, sanitation and hygiene and food hygiene sector should ensure that interventions are context-appropriate, and that effective methods of observation are used to confirm any reported effects of an intervention.",2020,"Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice.","['Child Caregiver Food Hygiene Practices in Rural Malawi', 'child caregivers with children under the age of five years in rural Malawi', 'Fifty-eight child caregivers from an intervention and 29 from a control group were recruited into the study']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],58.0,0.0155271,"Despite the effects of reactivity during observations, the study results imply that the intervention group did not just improve their knowledge, but also translated the messaging into better practice.","[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tilley', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Polytechnic University of Malawi, Private Bag 303, Chichiri, Blantyre 3, Malawi.'}]",International journal of environmental research and public health,['10.3390/ijerph17124498']
1646,32585907,Repeated Sprint Training vs. Repeated High-Intensity Technique Training in Adolescent Taekwondo Athletes-A Randomized Controlled Trial.,"This study investigated the effects of 4-weeks repeated sprint (RST) vs. repeated high-intensity-technique training (RTT) on physical performance. Thirty-six adolescent taekwondo athletes (age: 16 ± 1 yrs) were randomly assigned to RST (10 × 35 m sprint, 10 s rest), RTT (10 × 6 s Bandal-tchagui, 10 s rest) and control (control group (CG): no additional training) groups. Additionally, to their regular training, RST and RTT trained 2×/week for 4 weeks. Training load (TL), monotony, and strain were calculated using the rating of perceived exertion scale. The progressive specific taekwondo (PSTT), 20 m multistage shuttle run (SRT 20m ), 5 m shuttle run, agility T-test, taekwondo-specific agility (TSAT) and countermovement jump (CMJ) tests were performed before and after 4 weeks of training. Additionally, taekwondo athletes performed specific taekwondo exercises (i.e., repeated techniques for 10 s and 1 min). From week 1, mean TL increased continuously to week 4 and monotony and strain were higher at weeks 3 and 4 ( p  < 0.001). VO 2max  calculated from SRT 20m  and PSTT increased for RST and RTT in comparison to CG ( p  < 0.001). Agility performance during T-test and TSAT ( p  < 0.01) improved in RTT. The number of performed techniques during the 10 s specific exercise increased in RTT and RST ( p  < 0.01) for the dominant leg and in RTT for the non-dominant leg ( p  < 0.01). The number of techniques during the 1 min specific exercise was higher in RST and RTT compared to CG for the dominant leg ( p  < 0.001). Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p  < 0.01). It is important to include a low-volume high-intensity training based on repeated sprint running or repeated technique in the training programs of adolescent taekwondo athletes.",2020,Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p  < 0.01).,"['adolescent taekwondo athletes', 'Thirty-six adolescent taekwondo athletes (age: 16 ± 1 yrs', 'Adolescent Taekwondo Athletes']","['specific taekwondo exercises', 'control (control group (CG): no additional training', 'Repeated Sprint Training vs. Repeated High-Intensity Technique Training', 'RST ', '4-weeks repeated sprint (RST) vs. repeated high-intensity-technique training (RTT']","['RTT and RST', 'mean TL', 'Training load (TL), monotony, and strain', 'Delta lactate', 'physical performance', 'number of techniques during the 1 min specific exercise', 'Agility performance', 'VO 2max  calculated from SRT 20m  and PSTT', 'agility T-test, taekwondo-specific agility (TSAT) and countermovement jump (CMJ) tests']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",36.0,0.0261048,Delta lactate at post-training was lower for RTT for both legs compared to RST and CG ( p  < 0.01).,"[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Messaoudi', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Matthias Oliver', 'Initials': 'MO', 'LastName': 'Wagner', 'Affiliation': 'Department of Sport Science, Bundeswehr University Munich, 85579 Neubiberg, Germany.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of Cardio-Circulatory, Respiratory, Metabolic and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine, Ibn El Jazzar, Sousse 4000, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo 05508-030, Brazil.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Department of Sport Science, Bundeswehr University Munich, 85579 Neubiberg, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124506']
1647,32586394,Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol.,"OBJECTIVES


To assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are: a)more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were receiving standard oxygen therapy5.IMV in patients who at randomisation were receiving non-invasive mechanical ventilationb)Similar in terms of major bleeding risk TRIAL DESIGN: Multicentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital study.
PARTICIPANTS


Inpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit.
INCLUSION CRITERIA (ALL REQUIRED)


1. Age > 18 and < 80 years 2. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 3. Severe pneumonia defined by the presence of at least one of the following criteria: a.Respiratory Rate ≥25 breaths /minb.Arterial oxygen saturation≤93% at rest on ambient airc.PaO2/FiO2 ≤300 mmHg 4. Coagulopathy, defined by the presence of at least one of the following criteria: a.D-dimer >4 times the upper level of normal reference rangeb.Sepsis-Induced Coagulopathy (SIC) score >4 5. No need of IMV EXCLUSION CRITERIA: 1. Age <18 and >80 years 2. IMV 3. Thrombocytopenia (platelet count < 80.000 mm3) 4. Coagulopathy: INR >1.5, aPTT ratio > 1.4 5. Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min) 6. Known hypersensitivity to enoxaparin 7. History of heparin induced thrombocytopenia 8. Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant cancer at high risk of haemorrhage, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations) 9. Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves) 10. Concomitant double antiplatelet therapy 11. Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed 12. Pregnancy or breastfeeding or positive pregnancy test 13. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 14. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at standard prophylactic dose (i.e., 4000 UI subcutaneously once day). Intervention Group (High-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at dose of 70 IU/kg every 12 hours, as reported in the following table. This dose is commonly used in Italy when a bridging strategy is required for the management of surgery or invasive procedures in patients taking anti-vitamin K oral anticoagulants Body Weight (kg)Enoxaparin dose every 12 hours (IU)<50200050-69400070-89600090-1108000>11010000 The treatment with Enoxaparin will be initiated soon after randomization (maximum allowed starting time 12h after randomization). The treatment will be administered every 12 hours in the intervention group and every 24 hours in the control group. Treatments will be administered in the two arms until hospital discharge or the primary outcomes detailed below occur.
MAIN OUTCOMES


Primary Efficacy Endpoint: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were in standard oxygen therapy by delivery interfaces5.Need for IMV, in patients who at randomisation were in Cpap or NIV Time to the occurrence of each of these events will be recorded. Clinical worsening will be analysed as a binary outcome as well as a time-to-event one. Secondary Efficacy Endpoints: Any of the following events occurring within the hospital stay 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were in standard oxygen therapy by delivery interfaces5.Need for IMV in patients who at randomisation were in Cpap or NIV6.Improvement of laboratory parameters of disease severity, including: o D-dimer levelo Plasma fibrinogen levelso Mean Platelet Volumeo Lymphocyte/Neutrophil ratioo IL-6 plasma levels MORTALITY AT 30 DAYS: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation. Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one. Primary safety endpoint: Major bleeding, defined as an acute clinically overt bleeding associated with one or more of the following: Decrease in haemoglobin of 2 g/dl or more;Transfusion of 2 or more units of packed red blood cells;Bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal];Bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death);Bleeding that necessitates surgical intervention Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one. Secondary safety endpoint: Clinically Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of: 1.Any bleeding compromising hemodynamic2.Spontaneous hematoma larger than 25 cm2, or 100 cm2 if there was a traumatic cause3.Intramuscular hematoma documented by ultrasonography4.Epistaxis or gingival bleeding requiring tamponade or other medical intervention5.Bleeding from venipuncture for >5 minutes6.Haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures7.Haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention8.Any other bleeding requiring temporary cessation of a study drug. Time to the occurrence of each of these events will be recorded. Each of these events will be analysed as a binary outcome and as a time-to-event one.
RANDOMISATION


Randomisation (with a 1:1 randomisation ratio) will be centrally performed by using a secure, web-based system, which will be developed by the Methodological and Statistical Unit at the Azienda Ospedaliero-Universitaria of Modena. Randomisation stratified by 4 factors: 1) Gender (M/F); 2) Age (<75/≥75 years); 3) BMI (<30/≥30); 4) Comorbidities (0-1/>2) with random variable block sizes will be generated by STATA software. The web-based system will guarantee the allocation concealment. Blinding (masking) The study is conceived as open-label: patients and all health-care personnel involved in the study will be aware of the assigned group.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The target sample size is based on the hypothesis that LMWH administered at high doses versus low doses will significantly reduce the risk of clinical worsening. The overall sample size in this study is expected to be 300 with 150 in the Low-Dose LMWH control group and 150 in the High-Dose LMWH intervention group, recruited over 10-11 months. Assuming an alpha of 5% (two tailed) and a percentage of patients who experience clinical worsening in the control group being between 25% and 30%, the study will have 80% power to detect at least 50% relative reduction in the risk of death between low and high doses of heparin.
TRIAL STATUS


Protocol version 1.2 of 11/05/2020. Recruitment start (expected): 08/06/2020 Recruitment finish (expected): 30/04/2021 Trial registration EudraCT 2020-001972-13, registered on April 17th, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Coagulopathy: INR >1.5, aPTT ratio","['Inpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit', 'hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD', 'Age', 'Randomisation stratified by 4 factors: 1) Gender (M/F); 2) Age (<75/≥75 years); 3) BMI (<30/≥30); 4) Comorbidities (0-1/>2) with random variable block sizes will be generated by STATA software', 'hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV', 'Age > 18 and < 80 years 2']","['IMV', 'D-dimer', 'high versus low Low-Molecular Weight Heparin', 'LMWH', 'Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb', 'standard oxygen therapy5.IMV', 'LMWH intervention', 'aPTT ratio', 'Enoxaparin', 'standard oxygen therapy', 'Intervention Group (High-Dose LMWH', 'heparin', 'Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin', 'Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material', 'Control Group (Low-Dose LMWH', 'Enoxaparin (Inhixa®', 'enoxaparin', 'LMWH, fondaparinux, or unfractionated heparin (UFH']","['Thrombocytopenia', 'risk of death', 'symptomatic arterial or venous thromboembolism', 'Impaired renal function (eGFR', 'occurrence of at least one of the following events', 'hospital stay 1.Death2.Acute Myocardial Infarction', 'Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of: 1.Any bleeding compromising hemodynamic2.Spontaneous hematoma larger', 'Sepsis-Induced Coagulopathy (SIC) score', 'levelso Mean Platelet Volumeo Lymphocyte/Neutrophil ratioo IL-6 plasma levels', 'bleeding, defined as an acute clinically overt bleeding associated with one or more of the following: Decrease in haemoglobin of 2 g/dl or more;Transfusion of 2 or more units of packed red blood cells;Bleeding', 'Severe pneumonia', 'life expectancy']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0449209', 'cui_str': 'ORB'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1098510', 'cui_str': 'fondaparinux'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",,0.138155,"Coagulopathy: INR >1.5, aPTT ratio","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Dipartimento Oncologia ed Ematologia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy. marco.marietta@unimore.it.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vandelli', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mighali', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vicini', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Coluccio', 'Affiliation': 'Dipartimento Oncologia ed Ematologia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04475-z']
1648,32586395,"A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial"".","OBJECTIVES


Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group. The gammaCore® treatments will be used acutely and prophylactically. The active and control groups will be matched for disease and severity.
PARTICIPANTS


i. Inclusion Criteria The subjects have to meet all of the following criteria to be eligible to enter the trial: 1.Patient older than 18 years2.Been tested positive or suspected/presumed positive for CoViD-19 Has a cough, shortness of breath or respiratory O 2  Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failure 3.Agree to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data4.Patient is able to provide signed and witnessed Informed Consent ii. Exclusion Criteria Subjects meeting any of the following criteria cannot be included in this research study: 1.Pregnant women2.On home/therapy oxygen (i.e. for patients with Chronic Obstructive Pulmonary Disease) at baseline prior to development of CoViD-193.Patient already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-194.History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma5.Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction6.Uncontrolled high blood pressure (>140/90)7.Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant8.Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site9.Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) Participants will be recruited from Hospital Clínico Universitario de Valencia in Spain.
INTERVENTION AND COMPARATOR


Intervention: Prophylactic: Administer 2 doses (at 2 minutes each) of gammaCore® - Sapphire, one dose on each side of the neck scheduled three times a day (morning, mid-day and 1 hour before bed at night).Acute respiratory failure or shortness of breath: Administer 2 doses (at 2 minutes each) of gammaCore®-Sapphire, one on each side of the neck. If shortness of breath (SOB) persists 20 minutes after the start of the first treatment, a second dose will be administered. Max doses per day is 9 or 18 stimulations.Plus standard of care Control: Standard of care: oxygen therapy, antibiotics and ventilatory support if necessary depending on the clinic MAIN OUTCOMES: Primary Endpoint: Initiation of mechanical ventilation, from randomization until ICU admission or hospital discharge, whatever occurs first Secondary Endpoints: Safety; ascertainment of Adverse Effects/Serious Adverse Events, from randomisation to ICU admission or hospital discharge, whatever occurs firstCytokine Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β. Days 1,3,5,10,15 and/or at hospital dischargeMortality and/or need for Critical Care admission, from randomisation until ICU admission or hospital discharge, whatever occurs first,O2 saturation levels , from randomization until ICU admission or hospital discharge, whatever occurs firstNeed for supplemental oxygen, from randomisation until ICU admission or hospital discharge, whatever occurs first RANDOMISATION: The patients are classified according to their oxygen levels as mild, moderate and severe and randomized according to their classification to the intervention and control in a ratio of 1:1. The randomization will be stratified for gender and age.
BLINDING (MASKING)


This is an open label study, it is not possible to blind the participants and healthcare providers to the intervention.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The total number of patients to be included in the study is 90, with 45 in each study group TRIAL STATUS: The protocol version is 8.0 from 07 th  April 2020. The recruitment began 20th April 2020 and is expected to be complete 31st July 2020.
TRIAL REGISTRATION


The study is registered in clinicaltrials.gov on 29th April 2020 with the identification number: NCT04368156 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β.","['patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR', 'patients with Chronic Obstructive Pulmonary Disease) at baseline prior to development of CoViD-193.Patient already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-194.History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma5.Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction6.Uncontrolled high blood pressure ', 'patients with moderate to severe CoViD- 19', '1.Patient older than 18 years2.Been tested positive or suspected/presumed positive for CoViD-19 Has a cough, shortness of breath or respiratory O 2  Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failure 3.Agree', 'CoViD-19 patients •', 'homeless, developmentally disabled and prisoner', 'i. Inclusion Criteria', 'Participants will be recruited from Hospital Clínico Universitario de Valencia in Spain']","['gammaCore®-Sapphire device', 'gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group']","['ICU admission or hospital discharge, whatever occurs firstCytokine', 'respiratory distress', 'Tumor necrosis factor α, Interleukin 6, Interleukin 1β', 'mortality', 'mechanical ventilator dependency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0007273', 'cui_str': 'Disorder of carotid artery'}, {'cui': 'C0006318', 'cui_str': 'Bruit'}, {'cui': 'C0455536', 'cui_str': 'H/O: TIA'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4303880', 'cui_str': 'Presumptive positive'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C2733607', 'cui_str': 'Developmentally disabled'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0086954', 'cui_str': 'Sapphire'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]",,0.161092,"Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1β.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tornero', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain. carlostornero@gmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Department of Basic Science, Millennium Pain Center, Bloomington, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cedeño', 'Affiliation': 'Department of Basic Science, Millennium Pain Center, Bloomington, IL, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Orduña', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Pastor', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Belaouchi', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Benigno', 'Initials': 'B', 'LastName': 'Escamilla', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Mar Garzando', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Anaesthesia, Critical Care and Pain Management Unit, Valencia, Spain.'}]",Trials,['10.1186/s13063-020-04486-w']
1649,32586396,"CytoResc - ""CytoSorb"" Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. Currently, no causal therapy is available and treatment is purely supportive. The main reason for death in critically ill patients is acute respiratory failure. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. A new polystyrene-based hemoadsorber (CytoSorb®, Cytosorbents Inc., New Jersey, USA) has been shown to adsorb effectively cytokines and other middle molecular weight toxins this way reducing their blood concentrations. This has been routinely used in clinical practice in the EU for other conditions where a cytokine storm occurs and an observational study has just been completed on COVID-19 patients. We hypothesized that the extracorporeal elimination of cytokines in critically ill COVID-19 patients with suspected hyperinflammation and shock may stabilize hemodynamics and improve outcome. The primary endpoint is time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies.
TRIAL DESIGN


Phase IIb, multicenter, prospective, open-label, randomized, 1:1 parallel group pilot study comparing the additional use of ""CytoSorb"" to standard of care without ""CytoSorb"".
PARTICIPANTS


Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs). All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥ 100 mg/l, a Procalcitonin (PCT) < 2 ng/l, and suspected cytokine storm defined via a vasoplegic shock (Norepinephrine > 0.2 μg/min/kg to achieve a Mean Arterial Pressure ≥ 65mmHg). Patients are included irrespective of indication for renal replacement therapy. Suspected or proven bacterial cause for vasoplegic shock is a contraindication.
INTERVENTION AND COMPARATOR


Within 24 hours after meeting the inclusion criteria patients will be randomized to receive either standard of care or standard of care and additional ""CytoSorb"" therapy via a shaldon catheter for 3-7 days. Filter exchange is done every 24 hours. If patients receive antibiotics, an additional dose of antibiotics is administered after each change of ""CytoSorb"" filter in order to prevent underdosing due to ""CytoSorb"" treatment.
MAIN OUTCOMES


Primary outcome is time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg) in days. Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury.
RANDOMIZATION


An electronic randomization will be performed using the study software secuTrial® administered by the Clinical Study Center (CSC) of the Charité - Universitätsmedizin Berlin, Germany. Randomization is done in blocks by 4 stratified by including center.
BLINDING (MASKING)


The trial will be non-blinded for the clinicians and patients. The statistician will receive a blinded data set, so that all analyses will be conducted blinded.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


As this is a pilot study with the goal to examine the feasibility of the study design as well as the intervention effect, no formal sample size calculation was conducted. A total number of approximately 80-100 patients is planned (40-50 patients per group). Safety assessment is done after the inclusion of each 10 patients per randomization group.
TRIAL STATUS


Please see the study protocol version from April 24 2020. Recruitment of patients is still pending.
TRIAL REGISTRATION


The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury.
","['Patients are recruited from the Intensive Care Units (ICUs) of 7 participating centers in Germany (approximately 10 ICUs', 'critically ill patients undergoing the COVID-19 Cytokine Storm', 'The study was registered on April 27 2020 in the German Registry of Clinical Trials (DRKS) under the number DRKS00021447', 'All patients aged 18- 80 with positive polymerase chain reaction (PCR) test for SARS-CoV-2, a C-reactive protein (CRP) ≥']","['standard of care or standard of care and additional ""CytoSorb"" therapy via a shaldon catheter', 'CytoResc - ""CytoSorb"" Rescue', 'CytoSorb"" to standard of care without ""CytoSorb']","['7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury', 'time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies', 'time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAP ≥ 65mmHg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",,0.41212,"Secondary outcomes are 7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, Interleukin-6 (IL-6) measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of ""CytoSorb"" and acute kidney injury.
","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Stockmann', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Institute for Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Büttner', 'Affiliation': 'Department of Nephrology, Clinic Aschaffenburg-Alzenau, Aschaffenburg, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Jörres', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Kindgen-Milles', 'Affiliation': 'Department of Anesthesiology, University Hospital Düsseldorf, Heinrich-Heine-University Duesseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julius Valentin', 'Initials': 'JV', 'LastName': 'Kunz', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Leebmann', 'Affiliation': 'Interdisciplinary Apheresis Center at Passau General Hospital, Passau, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin (CCM, CVK), Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Träger', 'Affiliation': 'Department of Cardiac Anesthesiology, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Treskatsch', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin (CBF), Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Uhrig', 'Affiliation': 'Department of Internal Medicine/Infectious Diseases and Pulmonary Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Willam', 'Affiliation': 'Department of Internal Medicine 4-Nephrology and Hypertension, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Enghard', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Slowinski', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany. torsten.slowinski@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04501-0']
1650,32586399,Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Tissue hypoxia is the main cause of multi-organ dysfunction in sepsis. However, effective pharmacological treatments to combat sepsis-induced tissue hypoxia are not available. Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways. In addition, TH has favorable effects on the immune system and viral load in infected tissue. Non-Thyroid Illness Syndrome is common in sepsis, acute myocardial infarction and trauma and is associated with increased mortality. Thus, TH may be a novel treatment in the setting of critical illness due to viral infection in which hypoxia prevails. The present study aims to address the efficacy and safety of acute administration of triiodothyronine (T3) in critically ill COVID-19 infected patients requiring mechanical respiratory support or Extra Corporeal Membrane Oxygenation (ECMO).
TRIAL DESIGN


This study is a phase II, parallel, 2-arm (1:1 ratio), multi-centre, prospective, randomized, double-blind, placebo controlled trial.
PARTICIPANTS


Male and female patients aged over 18 years old who are diagnosed with pulmonary infection due to COVID-19, admitted to Intensive Care Unit and requiring mechanical ventilation or ECMO will be enrolled in this trial. Patients will be excluded in cases of pregnancy, severe systemic disease with life expectancy less than 6 months, participation in another trial of an investigational drug or device, corticosteroid and/or sympathomimetic use before initiation of treatment. All data will be collected in electronic CRF files. Participants will start to be recruited from the ICU center of ""ATTIKO"" University Hospital in Greece. We aim to include two more clinical sites in the trial one from Greece and one from Germany INTERVENTION AND COMPARATOR: Intervention: T3 Solution for injection 10 μg/ml. The dose administered will be 0.8g/kg i.v. bolus and will be followed by an infusion of 0.113g. kg-1.h-1 i.v. for 48 hours (therapeutic dose). After the first 48h, a maintenance dose will be administered corresponding to 50% of the therapeutic dose (0.057g. kg-1.h-1 i.v.). Drug administration will stop after successful weaning or end of follow up (maximum 30 days). Comparator: Placebo with composition and dosage identical apart from the active substance.
MAIN OUTCOMES


The primary outcome assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours.
RANDOMISATION


An allocation sequence to one of the groups will be prepared by the Sponsor of the study. A 1:1 treatment allocation will be adopted. An electronic CRF will be used incorporating IWRS in order to assure proper randomization and unblinding in emergency cases. The representative of the sponsor will get a copy of randomization codes. The information of the randomization codes will then be locked in the database until the time at which an interim analysis or final analysis is performed.
BLINDING (MASKING)


Participants, caregivers, and all investigators assessing the outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The sample size of 60 patients (that indicates 30 subjects for each group) will have 84% power to detect the estimated difference between the two study groups. The criterion for significance (alpha) has been set at 0.05 and the test is 2-tailed.
TRIAL STATUS


Protocol number T3inj-02/ThySupport, version 03, May 11, 2020. The trial is not recruiting yet. The trial will start recruitment June 18 th  2020. Estimated recruitment will finish June 18 th , 2021.
TRIAL REGISTRATION


Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support), ClinicalTrials.gov Identifier: NCT04348513, date of trial registration: April 16, 2020, EudraCT Identifier: 2020-001623-13, date of trial registration: April 22, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways.","['Critically Ill Patients With COVID-19 Infection (Thy-Support', 'Participants will start to be recruited from the ICU center of ""ATTIKO"" University Hospital in Greece', 'critically ill COVID-19 infected patients requiring mechanical respiratory support or Extra Corporeal Membrane Oxygenation (ECMO', 'Male and female patients aged over 18 years old who are diagnosed with pulmonary infection due to COVID-19, admitted to Intensive Care Unit and requiring mechanical ventilation or ECMO will be enrolled in this trial', 'Patients will be excluded in cases of pregnancy, severe systemic disease with life expectancy less than 6 months, participation in another trial of an investigational drug or device, corticosteroid and/or sympathomimetic use before initiation of treatment', 'critically ill patients with COVID-19 infection', 'Protocol number T3inj-02/ThySupport, version 03, May 11, 2020']","['Placebo', 'Comparator', 'triiodothyronine (T3', 'Triiodothyronine', 'placebo']",['efficacy and safety'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039052', 'cui_str': 'Sympathomimetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.495902,"Emerging experimental and clinical evidence reveals an evolutionary conserved action of thyroid hormone (TH) to adapt injured tissue to hypoxic conditions via its action on p38 MAPK, Akt signaling pathways.","[{'ForeName': 'Constantinos', 'Initials': 'C', 'LastName': 'Pantos', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece. cpantos@med.uoa.gr.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Kostopanagiotou', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Armaganidis', 'Affiliation': '2nd Department of Critical Care, ""Attikon"" University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Trikas', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Ioulia', 'Initials': 'I', 'LastName': 'Tseti', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}, {'ForeName': 'Iordanis', 'Initials': 'I', 'LastName': 'Mourouzis', 'Affiliation': 'Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias Ave.,11527 Goudi, Athens, Greece.'}]",Trials,['10.1186/s13063-020-04474-0']
1651,32590049,"Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture.","Romosozumab (EVENITY™ [romosozumab-aqqg in the US]) is a humanized monoclonal antibody that inhibits sclerostin and has been approved in several countries for the treatment of osteoporosis in postmenopausal women at high risk of fracture. Sclerostin is expressed in bone and aortic vascular smooth muscle (AVSM). Its function in AVSM is unclear but it has been proposed to inhibit vascular calcification, atheroprogression, and inflammation. An increased incidence of positively adjudicated serious cardiovascular adverse events driven by an increase in myocardial infarction and stroke was observed in romosozumab-treated subjects in a clinical trial comparing alendronate with romosozumab (ARCH; NCT01631214) but not in a placebo-controlled trial (FRAME; NCT01575834). To investigate the effects of sclerostin inhibition with sclerostin antibody on the cardiovascular system, a comprehensive nonclinical toxicology package with additional cardiovascular studies was conducted. Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis. These nonclinical studies did not identify evidence that proves the association between sclerostin inhibition and adverse cardiovascular function, increased cardiovascular calcification, and atheroprogression.",2020,"Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis.",['postmenopausal women at high risk of fracture'],"['sclerostin inhibition with sclerostin antibody', 'romosozumab, an inhibitor of sclerostin', 'alendronate', 'Sclerostin', 'Romosozumab (EVENITY™ [romosozumab-aqqg']",['myocardial infarction and stroke'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4765894', 'cui_str': 'Evenity'}, {'cui': 'C4765888', 'cui_str': 'romosozumab-aqqg'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0719188,"Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Turk', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA. Electronic address: jturk@amgen.com.'}, {'ForeName': 'Aimee M', 'Initials': 'AM', 'LastName': 'Deaton', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Genome Analysis Unit, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Stolina', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Felx', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Boyd', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Jean-Guy', 'Initials': 'JG', 'LastName': 'Bienvenu', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Varela', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Guillot', 'Affiliation': 'Charles River Laboratories Montreal ULC, Senneville, QC, Canada.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Holdsworth', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wolfreys', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dwyer', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sheetal V', 'Initials': 'SV', 'LastName': 'Kumar', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'de Koning', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engwall', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Locher', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Lucas D', 'Initials': 'LD', 'LastName': 'Ward', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Cambridge, MA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Glaus', 'Affiliation': 'Cardiometabolic Disorders Research, Amgen Research, Thousand Oaks, CA, USA.'}, {'ForeName': 'Yudong D', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA; Genome Analysis Unit, Amgen Research, South San Francisco, CA, USA.'}, {'ForeName': 'Rogely Waite', 'Initials': 'RW', 'LastName': 'Boyce', 'Affiliation': 'Translational Safety and Bioanalytical Sciences, Amgen Research, Thousand Oaks, CA, USA.'}]",Regulatory toxicology and pharmacology : RTP,['10.1016/j.yrtph.2020.104697']
1652,32590084,Blood transfusion and ischaemic outcomes according to anemia and bleeding in patients with non-ST-segment elevation acute coronary syndromes: Insights from the TAO randomized clinical trial.,"BACKGROUND


The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI).
METHODS


The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status.
RESULTS


12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001).
CONCLUSION


In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.",2020,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"['patients with NST-elevation myocardial infarction (NSTEMI', 'The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to', 'patients with acute myocardial infarction who are anemic or who experience bleeding are debated', 'patients with non-ST-segment elevation acute coronary syndromes', '12,547 patients were enrolled']","['blood transfusion', 'coronary artery bypass surgery', 'heparin plus eptifibatide versus otamixaban']","['anemia and bleeding', 'GRACE score and nadir of hemoglobin', 'risk of ischaemic events', 'composite of all-cause death or MI', 'Blood transfusion and ischaemic outcomes', 'rate of death or MI', 'blood transfusion', 'haemoglobin nadir and bleeding status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12547.0,0.115362,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France; Aix Marseille Univ, Inserm, Inra, C2VN, Marseille, France; Aix-Marseille Université, Faculté de Médecine, F-13385 Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center Freiburg University, Cardiology and Angiology I, Faculty of Medicine, Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Cardiology, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Pilsonu Street 13, Riga, Latvia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Fondazione Cardiocentro Ticino, via Tesserete 48, 6900 Lugano, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Diderot, Département Hospitalo-Universitaire FIRE, Sorbonne-Paris Cité, Paris, France; FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network,l: NHLI, Royal Brompton Hospital, Imperial College, London, United Kingdom. Electronic address: gabriel.steg@aphp.fr.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.020']
1653,32590942,Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.,"BACKGROUND


This study aimed to assess the pharmacokinetic profile of 150 mg rifabutin (RBT) taken every other day (every 48 h) versus 300 mg RBT taken every other day (E.O.D), both in combination with lopinavir/ritonavir (LPV/r), in adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB) co-infection.
METHODS


This is a two-arm, open-label, pharmacokinetic, randomised study conducted in Burkina Faso between May 2013 and December 2015. Enrolled patients were randomised to receive either 150 mg RBT EOD (arm A, 9 subjects) or 300 mg RBT EOD (arm B, 7 subjects), both associated with LPV/r taken twice daily. RBT plasma concentrations were evaluated after 2 weeks of combined HIV and TB treatment. Samples were collected just before drug ingestion and at 1, 2, 3, 4, 6, 8, and 12 h after drug ingestion to measure plasma drug concentration using an HPLC-MS/MS assay.
RESULTS


The Cmax and AUC 0-12h  medians in arm A (Cmax = 296 ng/mL, IQR: 205-45; AUC 0-12h  = 2528 ng.h/mL, IQR: 1684-2735) were lower than those in arm B (Cmax = 600 ng/mL, IQR: 403-717; AUC 0-12h  = 4042.5 ng.h/mL, IQR: 3469-5761), with a statistically significant difference in AUC 0-12h  (p = 0.044) but not in Cmax (p = 0.313). No significant differences were observed in Tmax (3 h versus 4 h). Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm. Additionally, at 48 h after drug ingestion, all patients had a mycobacterial minimum inhibitory concentration (MIC) above the limit (> 64 ng/mL) in the 300 mg RBT arm, while 4/9 patients had such values in the 150 mg RBT arm.
CONCLUSION


This study confirmed that the 150 mg dose of rifabutin ingested EOD in combination with LPV/r is inadequate and could lead to selection of rifamycin-resistant mycobacteria.
TRIAL REGISTRATION


PACTR201310000629390, 28th October 2013.",2020,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","['Burkina Faso between May 2013 and December 2015', 'African HIV and tuberculosis co-infected adult patients', 'adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB']","['rifabutin ingested EOD', 'rifabutin doses co-administered with lopinavir/ritonavir', '300\u2009mg RBT EOD', '150\u2009mg RBT EOD', 'lopinavir/ritonavir (LPV/r', 'rifabutin (RBT']","['RBT plasma concentrations', 'Cmax below the plasma therapeutic limit', 'Tmax', 'mycobacterial minimum inhibitory concentration (MIC', 'Cmax and AUC']","[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0066256', 'cui_str': 'Methyl isocyanate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",2735.0,0.0847334,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","[{'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso. skouanda@irss.bf.'}, {'ForeName': 'Henri Gautier', 'Initials': 'HG', 'LastName': 'Ouedraogo', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Kadari', 'Initials': 'K', 'LastName': 'Cisse', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Tegwinde Rebeca', 'Initials': 'TR', 'LastName': 'Compaoré', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Sulis', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Diagbouga', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Roggi', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}, {'ForeName': 'Grissoum', 'Initials': 'G', 'LastName': 'Tarnagda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Villani', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Lassana', 'Initials': 'L', 'LastName': 'Sangare', 'Affiliation': 'Yalgado Ouedraogo University Teaching Hospital, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Simporé', 'Affiliation': 'Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA), Ouagadougou, Burkina Faso.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Regazzi', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Matteelli', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}]",BMC infectious diseases,['10.1186/s12879-020-05169-2']
1654,32593069,Affective responses to climbing exercises in children and adolescents during in-patient treatment for mental health disorders a pilot study on acute effects of different exercise interventions.,"The aim of the present study was to compare acute effects of a climbing intervention (CI) on affective responses with a different exercise intervention (swimming, SI) and an occupational therapy intervention (OTI) in children and adolescents during in-patient treatment for mental health disorders. The following study was designed as a cross-over study. Participants completed three single 60 min interventions of CI, SI and OTI. Affective responses were assessed pre and post intervention and at 20 and 40 min during intervention. The sample consisted of 33 children and adolescents in mental-health inpatient care (ᴓage: 13.3 ± 2.2 years, ♀=39.4%). A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144. Repeated measures ANOVAs revealed a significant time by intervention effect for affective valence (p=.011, eta²=0.09), but not for perceived activation, favouring CI over SI and OCT between pre-test and the first 20 or 40 min, respectively. All interventions showed similar effects on affective responses pre to post interventions. CI seems to increase affective valence more strongly during intervention compared to SI and OTI. The present results may have implications for therapy adherence and acute emotion regulation in children and adolescent in-patients with mental health disorders.",2020,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","['children and adolescent in-patients with mental health disorders', '33 children and adolescents in mental-health inpatient care (ᴓage: 13.3\xa0±\xa02.2 years, ♀=39.4', 'children and adolescents during in-patient treatment for mental health disorders']","['exercise intervention (swimming, SI) and an occupational therapy intervention (OTI', 'exercise interventions', 'climbing exercises', 'climbing intervention (CI']","['perceived activation, favouring CI over SI and OCT', 'affective valence', 'Affective responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",33.0,0.0311106,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frühauf', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria. Electronic address: anika.fruehauf@uibk.ac.at.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Sevecke', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Haid-Stecher', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Albertini', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schipflinger', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}]",Psychiatry research,['10.1016/j.psychres.2020.113245']
1655,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250']
1656,32593154,Alpha-tACS effect on inhibitory control and feasibility of administration in community outpatient substance use treatment.,"BACKGROUND


Deficits in inhibitory control (IC) and distress tolerance (DT) are associated with substance use disorders (SUD) and post-treatment return to substance use. Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT. The aims of the current study were to examine the feasibility and acceptability of administering tACS in a community-based SUD treatment setting, and to test the effect of alpha-tACS on IC and DT.
METHOD


A double-blind, randomized, active sham-controlled trial of treatment-seeking adults with a SUD (N = 30, Mean age  = 43.2 years, 70.0% male). Participants attended two sessions and completed computerized inhibitory control and distress tolerance tasks while receiving tACS targeting the bilateral dorsolateral prefrontal cortex (DLPFC). Participants received sham-tACS and were then randomized to receive sham-, alpha-, or gamma-tACS within 2-3 days.
RESULTS


Treatment retention was 87%. Participant self-reported belief of having received tACS and mean side effect intensity ratings did not differ across conditions, with all side effect ratings in the absent to mild range. There was a large (d = 0.83) and significant effect of alpha-tACS on inhibitory control compared to sham-tACS (β = 1.78, SE = 0.65, 95 % CI: 0.41, 3.14, p<0.01). There were no significant effects of condition on distress tolerance.
CONCLUSIONS


To our knowledge, this is the first study of tACS in adults with a SUD. Our findings provide preliminary evidence for recruitment, retention, and administration feasibility of tACS in a community-based substance use treatment program and a beneficial effect of alpha-tACS on inhibitory control.",2020,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"['treatment-seeking adults with a SUD (N = 30, Mean age  = 43.2 years, 70.0% male', 'adults with a SUD']","['Transcranial alternating current stimulation (tACS', 'sham-, alpha-, or gamma-tACS', 'alpha-tACS', 'tACS', 'sham-tACS', 'computerized inhibitory control and distress tolerance tasks while receiving tACS']","['feasibility and acceptability', 'distress tolerance']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0861259,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"[{'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA. Electronic address: daughter@unc.edu.'}, {'ForeName': 'Jennifer Y', 'Initials': 'JY', 'LastName': 'Yi', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carelli', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108132']
1657,32475095,Efficacy and Safety of Abdominal Trunk Muscle Strengthening Using an Innovative Device in Elderly Patients With Chronic Low Back Pain: A Pilot Study.,"OBJECTIVE


To examine the efficacy and safety of an innovative, device-driven abdominal trunk muscle strengthening program, with the ability to measure muscle strength, to treat chronic low back pain (LBP) in elderly participants.
METHODS


Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated with the prescribed exercise regimen. Patients participated in a 12-week device-driven exercise program which included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities. Primary outcomes were adverse events associated with the exercise program, improvement in abdominal trunk muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP with the exercise. Secondary outcomes were improvement in the Roland-Morris Disability Questionnaire (RDQ) score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests.
RESULTS


There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program. The mean abdominal trunk muscle strength, NRS, RDQ scores, and the stand-up and two-step test scores were significantly improved at the end of the trial compared to baseline.
CONCLUSION


No participants experienced adverse events during the 12-week strengthening program, which involved the use of our device and stretching, indicating the program was safe. Further, the program significantly improved various measures of LBP and physical function in elderly participants.",2020,There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program.,"['Elderly Patients With Chronic Low Back Pain', 'elderly participants', 'Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated with the prescribed exercise regimen']","['innovative, device-driven abdominal trunk muscle strengthening program', 'Abdominal Trunk Muscle', 'device-driven exercise program which included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities', 'Strengthening Using an Innovative Device']","['back pain or new-onset abdominal pain or discomfort', 'Roland-Morris Disability Questionnaire (RDQ) score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests', 'adverse events associated with the exercise program, improvement in abdominal trunk muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP with the exercise', 'LBP and physical function', 'efficacy and safety', 'mean abdominal trunk muscle strength, NRS, RDQ scores, and the stand-up and two-step test scores', 'adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4087189', 'cui_str': 'Locomotive syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",7.0,0.0363891,There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program.,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Demura', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Shinmura', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Yokogawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}]",Annals of rehabilitation medicine,['10.5535/arm.19100']
1658,32483851,Effects of home-based pelvic floor muscle training on decreasing symptoms of stress urinary incontinence and improving the quality of life of urban adult Omani women: A randomized controlled single-blind study.,"AIM


This study aims to determine the effectiveness of home-based pelvic floor muscle training (PFMT) on decreasing the severity of symptoms and improving the quality of life (QOL) among Omani women with stress urinary incontinence (SUI).
METHODS


A randomized controlled single-blind trial was conducted in three primary health care centers in Muscat. Eligible women who were diagnosed with SUI (from a concurrent phase-I study which was a cross-sectional study to determine the prevalence of urinary incontinence in Oman) were invited to take part. The consenting subjects were randomly allocated to either an intervention group (unsupervised PFMT) or a control group (lecture with no PFMT). Baseline and 12-week assessment of both groups was carried out for the primary outcome using the validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer.
RESULTS


A total of 73 subjects were included in the study. They were randomly divided into two groups. Both groups were similar at the baseline in terms of sociodemographic characteristics, ICIQ score, and PFM strength. At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one. There was no statistical difference between the two groups in MOGS, endurance, or perineometer values.
CONCLUSIONS


The home-based PFMT is an effective treatment in reducing the severity of symptoms and improving the QOL in women with SUI.",2020,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","['women with SUI', 'Omani women with stress urinary incontinence (SUI', 'three primary health care centers in Muscat', 'A total of 73 subjects were included in the study', 'urban adult Omani women', 'urinary incontinence in Oman', 'Eligible women who were diagnosed with SUI (from a concurrent phase']","['home-based pelvic floor muscle training', 'intervention group (unsupervised PFMT', 'home-based pelvic floor muscle training (PFMT', 'control group (lecture with no PFMT']","['quality of life', 'validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer', 'ICIQ score', 'MOGS, endurance, or perineometer values', 'quality of life (QOL', 'sociodemographic characteristics, ICIQ score, and PFM strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205871', 'cui_str': 'Muscat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0491718', 'cui_str': 'Perineometer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",73.0,0.0513096,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","[{'ForeName': 'Zalikha I', 'Initials': 'ZI', 'LastName': 'Al Belushi', 'Affiliation': 'Department of Primary Care, North Batinah Governorate, Ministry of Health, Suhar, Oman.'}, {'ForeName': 'Maisa H', 'Initials': 'MH', 'LastName': 'Al Kiyumi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Ahlaam A', 'Initials': 'AA', 'LastName': 'Al-Mazrui', 'Affiliation': 'Physiotherapy Department, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jaju', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Alrawahi', 'Affiliation': 'Department of Research and Studies, Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Al Mahrezi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}]",Neurourology and urodynamics,['10.1002/nau.24404']
1659,32479701,Vitamin D and stress urinary incontinence in pregnancy: a cross-sectional study.,"OBJECTIVE


To assess the association between levels of vitamin D and urinary incontinence (UI) in pregnancy.
DESIGN


A cross-sectional study. Secondary analysis of a randomised controlled trial.
SETTING


Two university hospitals in Norway.
POPULATION


A total of 851 healthy, pregnant women >18 years in gestational weeks 18-22 with a singleton live fetus.
METHODS


Data on UI were collected from a questionnaire at inclusion and serum analysis of 25-hydroxy vitamin D (25(OH)D) was performed. Univariable and multivariable logistic regression analyses were applied to study associations between exposure and outcomes.
MAIN OUTCOME MEASURES


Prevalence of self-reported UI, stress (SUI) and urge (UUI) or mixed UI.
RESULTS


In total, 230/851 (27%) of the participants were vitamin D insufficient (25(OH)D <50 nmol/l) and 42% reported to have any UI. Women with 25(OH)D <50 nmol/l were more likely to report any UI (P = 0.03) and SUI (P < 0.01) compared with women with 25(OH)D ≥50 nmol/l. In a univariable logistic regression analysis, serum levels of 25(OH)D <50 nmol/l was associated with increased risk of any UI (odds ratio [OR] 1.5 with 95% CI 1.0-2.1), SUI only (OR 1.7, 95% CI 1.2-2.4), but not mixed UI or UUI only (OR 0.8, 95% CI 0.5-1.5). In a multivariable logistic regression model, serum levels of 25(OH)D <50 nmol/l were associated with a higher risk of experiencing SUI only (OR 1.5, 95% CI 1.1-2.2).
CONCLUSIONS


Serum 25(OH)D <50 nmol/l was associated with increased risk of any UI, and SUI in particular.
TWEETABLE ABSTRACT


Low levels of vitamin D are associated with increased risk of urinary incontinence in pregnancy.",2020,<50nmol/L were more likely to report any UI (p=0.03) and SUI (p<0.01) compared to women with 25(OH)D ≥50nmol/L.,"['Population 851 healthy, pregnant women >18 years in gestational week 18-22 with a singleton live fetus', 'Data on UI were collected from a questionnaire at inclusion and serum analysis of 25-hydroxy vitamin D (25(OH)D) was performed', 'Women with 25(OH)D', 'pregnancy', 'Setting Two university hospitals in Norway']",['Vitamin D'],"['vitamin D and urinary incontinence (UI', 'Prevalence of self-reported UI, stress (SUI) and urge (UUI) or mixed UI', 'risk of any UI and SUI']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",851.0,0.0672972,<50nmol/L were more likely to report any UI (p=0.03) and SUI (p<0.01) compared to women with 25(OH)D ≥50nmol/L.,"[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Syversen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Stunes', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'K Å', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Johannessen', 'Affiliation': 'Department for Physical Medicine and Rehabilitation, Østfold Hospital Trust, Sarpsborg, Norway.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16340']
1660,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1661,32480409,"Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men.","CONTEXT


Most labs set the lower limit of normal for testosterone at the 2.5th percentile of values in young or age-matched men, an approach that does not consider the physiologic changes associated with various testosterone concentrations.
OBJECTIVE


To characterize the dose-response relationships between gonadal steroid concentrations and measures regulated by gonadal steroids in older men.
DESIGN, PARTICIPANTS, AND INTERVENTION


177 men aged 60 to 80 were randomly assigned to receive goserelin acetate plus either 0 (placebo), 1.25, 2.5, 5, or 10 grams of a 1% testosterone gel daily for 16 weeks or placebos for both medications (controls).
PRIMARY OUTCOMES


Changes in serum C-telopeptide (CTX), total body fat by dual energy X-ray absorptiometry, and self-reported sexual desire.
RESULTS


Clear relationships between the testosterone dosage (or the resulting testosterone levels) and a variety of outcome measures were observed. Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0 to 99, 100 to 199, 200 to 299, or 300 to 499 ng/dL, whereas increases in total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels were 0 to 99 or 100 to 199 ng/dL. Sexual desire and erectile function were indistinguishable from controls until testosterone levels were <100 ng/dL.
CONCLUSION


Changes in measures of bone resorption, body fat, and sexual function begin at a variety of testosterone concentrations with many outcome measures remaining stable until testosterone levels are well below the stated normal ranges. In light of this variation, novel approaches for establishing the normal range for testosterone are needed.",2020,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"['Aging Men', '177 men ages 60-80', 'older men']","['testosterone gel daily for 16 weeks, or placebos', 'goserelin acetate plus either 0']","['Sexual desire and erectile function', 'serum CTX', 'total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels', 'bone resorption, body fat, and sexual function', 'serum C-telopeptide (CTX), total body fat by dual energy x-ray absorptiometry (DXA), and self-reported sexual desire', 'Bone, Body Composition, and Sexual Function']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0765777,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"[{'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Finkelstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Sherri-Ann M', 'Initials': 'SM', 'LastName': 'Burnett-Bowie', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Darakananda', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Gentile', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Goldstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Prizand', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Krivicich', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Taylor', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Kendra E', 'Initials': 'KE', 'LastName': 'Wulczyn', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}, {'ForeName': 'Elaine W', 'Initials': 'EW', 'LastName': 'Yu', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa318']
1662,32481420,Removal of the root canal smear layer using Carisolv III and sodium hypochlorite.,"The present study investigated the effectiveness of a Carisolv III + 0.5% sodium hypochlorite (NaOCl)-based root canal irrigant for smear layer removal.Forty maxillary incisors were randomly divided into 4 groups (n = 10 per group). The canals in group A (experimental) were prepared with 0.5% NaOCl, and Carisolv III and 0.5% NaOCl was used for the final washing; groups B and C (positive controls) used 2% and 5.25% NaOCl, respectively; and group D (negative control) used phosphate-buffered saline (PBS). Ethylenediaminetetraacetic acid (EDTA) was used for all of the groups. A 5-point scoring scale and scanning electron microscopy were used to evaluate the effectiveness of the irrigants. The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively (P < .05). The 2% NaOCl solution showed similar results to 0.5% NaOCl + Carisolv III (P > .05). The combination of 5.25% NaOCl and 17% EDTA remains the most effective irrigant for removal of the root canal smear layer.A combination of Carisolv III + 0.5% NaOCl (with 17% EDTA) showed a cleaning ability similar to that of 2% NaOCl (with 17% EDTA).",2020,"The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively",['Forty maxillary incisors'],"['root canal smear layer using Carisolv III and sodium hypochlorite', 'phosphate-buffered saline (PBS', 'Carisolv III\u200a+\u200a0.5% NaOCl (with 17% EDTA', '0.5% NaOCl, and Carisolv III and 0.5% NaOCl', 'Carisolv III + 0.5% sodium hypochlorite (NaOCl)-based root canal irrigant', 'Ethylenediaminetetraacetic acid (EDTA']",[],"[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035846', 'cui_str': 'Root canal medicament'}]",[],,0.0203118,"The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Yong-Zhen', 'Initials': 'YZ', 'LastName': 'Ma', 'Affiliation': ""Department of Stomatology, Tai'an City Central Hospital, Tai'an.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Department of Stomatology, Tai'an City Central Hospital, Tai'an.""}, {'ForeName': 'Bing-Chang', 'Initials': 'BC', 'LastName': 'Xin', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Da-Shan', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'De-Gang', 'Initials': 'DG', 'LastName': 'Sun', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Ling-Xiang', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}]",Medicine,['10.1097/MD.0000000000020372']
1663,32481431,Simple resistance exercise decreases cytokeratin 18 and fibroblast growth factor 21 levels in patients with nonalcoholic fatty liver disease: A retrospective clinical study.,"Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes. Exercise therapy is one of the established treatments for NAFLD; however, few studies have investigated the effectiveness of exercise therapy on CK18 and FGF21 levels. Therefore, the aim of the present study was to assess the effects of 12 weeks of simple resistance exercise on CK18 and FGF21 levels in patients with NAFLD.Fifty patients with NAFLD were assigned to a resistance exercise group (n = 23) or a control group (n = 27) for a trial period of 12 weeks. During the study, the resistance exercise group performed two exercises (push-ups and squats) three times a week on nonconsecutive days, whereas the control group proceeded with regular physical activities under a restricted diet. We then compared serum levels of CK18 fragments (M65) and FGF21 between groups just before and after the 12-week period.Serum M65 levels (880.0 ± 503.6 vs 648.9 ± 450.2 U/L; P < .01) were significantly decreased in the exercise group. However, no significant differences were observed in body mass index or skeletal muscle. The decreases in serum M65 (-231.1 ± 354.7 vs 56.2 ± 375.0 U/L; P = .02), and FGF21 levels (-41.7 ± 98.2 vs. 33.2 ± 127.6 pg/mL; P = .03) were significantly greater in the exercise than in the control group. Changes in M65 levels in the exercise group were significantly correlated with changes in alanine aminotransferase levels (r = 0.618, P < .01).Simple resistance exercise reduced CK18 and FGF21 levels in patients with NAFLD. These findings suggest that resistance exercise consisting of push-ups and squats helps prevent the progression of NAFLD.",2020,Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes.,"['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', 'patients with nonalcoholic fatty liver disease (NAFLD', 'patients with NAFLD.Fifty patients with NAFLD']","['Simple resistance exercise', 'Exercise therapy', 'simple resistance exercise', 'control group proceeded with regular physical activities under a restricted diet', 'resistance exercise']","['alanine aminotransferase levels', 'progression of NAFLD', 'body mass index or skeletal muscle', 'CK18 and FGF21 levels', 'serum M65', 'serum levels of CK18 fragments (M65) and FGF21', 'FGF21 levels', 'Serum M65 levels (880.0\u200a±', 'M65 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",,0.0205257,Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': ''}, {'ForeName': 'Kazumichi', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': ''}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': ''}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okai', 'Affiliation': ''}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Ohira', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020399']
1664,32488889,Effectiveness of different parenting interventions on oral hygiene of cerebral palsy children: A randomized controlled trial.,"AIM


To assess the effectiveness of different parenting interventions for improving oral hygiene of cerebral palsy (CP) children aged 4-12 years.
METHODOLOGY AND RESULTS


A randomized controlled trial was done among 60 CP children and parents visiting a tertiary care center in New Delhi. The study population was randomly assigned to experimental or control group (30 in each group). Parents/caregivers in the experimental group (Group 1) received video-based dental health education (DHE) and the control group (Group 2) received conventional DHE. Each group also received two telephonic reinforcements at fourth and eighth week after the first intervention at baseline. The groups were assessed for sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status. At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05). The mean reductions seen in Group 2 were 0.03 in OHI-S, 0.14 in PI, and 0.04 in GI index (P-value < .05, except for GI score: P-value = .6).
CONCLUSION


Video-based DHE is effective and brings about significant improvement in oral hygiene status and oral health among CP children.",2020,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","['60 CP children and parents visiting a tertiary care center in New Delhi', 'cerebral palsy (CP) children aged 4-12 years', 'cerebral palsy children', 'CP children']","['Video-based DHE', 'parenting interventions', 'video-based dental health education (DHE) and the control group (Group 2) received conventional DHE']","['oral hygiene status and oral health', 'sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status', 'simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores']","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0610275,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","[{'ForeName': 'Vedha', 'Initials': 'V', 'LastName': 'Vpk', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Vikrant R', 'Initials': 'VR', 'LastName': 'Mohanty', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Aswini Y', 'Initials': 'AY', 'LastName': 'Balappanavar', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Department of Pediatrics, Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12481']
1665,32585803,Fostering Broad Oral Language Skills in Preschoolers from Low SES Background.,"Socioeconomic disparities increase the probability that children will enter school behind their more advantaged peers. Early intervention on language skills may enhance language and literacy outcomes, reduce the gap and, eventually, promote school readiness of low-SES (Socioeconomic Status) children. This study aimed to analyze the feasibility and effectiveness of a brief narrative-based intervention (treatment vs. control group) aimed to foster broad oral language skills in preschoolers (N = 69; Mean age = 5.5, SD = 4 months) coming from low-SES families. Moreover, it was analyzed whether children's initial vocabulary mediates the intervention's responsiveness. Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures. There is also some evidence for the generalizability of the intervention to other skills not directly trained during the intervention. Moreover, it was found that children's initial vocabulary mediates the intervention's responsiveness showing that children with high vocabulary made greater gains in higher-level components of language comprehension, whereas children with low vocabulary made higher gains in vocabulary. Taken together, our findings suggest that a relatively brief, but quite intensive narrative-based intervention, may produce improvements on broad oral language skills in preschoolers from low-SES backgrounds.",2020,Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures.,"['Preschoolers from Low SES ', 'preschoolers (N = 69; Mean age = 5.5, SD = 4 months) coming from low-SES families']",['brief narrative-based intervention (treatment vs. control group) aimed to foster broad oral language skills'],"['language skills may enhance language and literacy outcomes, reduce the gap and, eventually, promote school readiness of low-SES (Socioeconomic Status) children', 'broad oral language skills', 'feasibility and effectiveness']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",69.0,0.0211223,Results have shown that children in treatment group obtained greater gains than children in control group in almost all intervention-based measures.,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Dicataldo', 'Affiliation': 'Department of Development and Socialization Psychology, University of Padova, 35131 Padova, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Florit', 'Affiliation': 'Department of Human Sciences, University of Verona, 37129 Verona, Italy.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Roch', 'Affiliation': 'Department of Development and Socialization Psychology, University of Padova, 35131 Padova, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124495']
1666,32589073,"Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial.","OBJECTIVES


Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA.
METHODS


This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment.
RESULTS


After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, -8.68 mm; two-sided 95% CI -16.59 mm to -0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity.
CONCLUSIONS


CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.",2020,"CONCLUSIONS


CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","['patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA', '119 eligible subjects']","['CELBESTA® versus CELEBREX®', 'CELBESTA® and CELEBREX®', 'Celecoxib']","['incidence of gastrointestinal (GI) complications', 'GI complications and renal toxicity', 'efficacy and safety', 'change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale', 'tolerability and safety profiles', 'pain relief efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0719198', 'cui_str': 'Celebrex'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",119.0,0.734665,"CONCLUSIONS


CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","[{'ForeName': 'Hyun-Sook', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Ho', 'Initials': 'WH', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University Hospital, JinJu, Republic of Korea.'}, {'ForeName': 'Sang-Hyon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Geun-Tae', 'Initials': 'GT', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jin-Wuk', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Myeung-Su', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea.'}, {'ForeName': 'Yun Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520931323']
1667,32484259,Repositioning for pressure injury prevention in adults.,"BACKGROUND


A pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.
OBJECTIVES


To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.
SEARCH METHODS


We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.
SELECTION CRITERIA


Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.
DATA COLLECTION AND ANALYSIS


Three review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.
MAIN RESULTS


We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials. Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision. One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision. In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision. Positioning regimens: four trials compared different tilt positions We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision. One trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence. Secondary outcomes No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction. Cost analysis Two included trials also performed economic analyses. A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed. A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR -46.50, 95% CI EUR -1.25 to EUR -74.60).
AUTHORS' CONCLUSIONS


Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base. Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus ""usual care"" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.",2020,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[""120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence"", '3941 participants from acute and long-term care settings and two economic substudies in the review', '262 participants in 32 ward clusters', 'adults', 'adults in any setting', 'nursing home residents', 'adults regardless of risk in any setting', 'two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69', '116 ICU patients']","['2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses', '3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation', 'tilt positions']","['health-related quality of life utility scores, procedural pain, or patient satisfaction', 'cost of repositioning', 'Cost analysis', 'incidence of stage 1 or 2 PI', 'proportion of new PI of any stage Repositioning frequencies', 'cost-saving', 'RR for PI incidence', 'incidence of PI']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0585322', 'cui_str': 'Every two hours'}, {'cui': 'C0585323', 'cui_str': 'Every three hours'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",116.0,0.24709,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[{'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Gillespie', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Walker', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Latimer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Lukman', 'Initials': 'L', 'LastName': 'Thalib', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Health Economics Group, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McInnes', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Australia Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Fitzroy, Melbourne, Australia.""}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Chaboyer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009958.pub3']
1668,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND


The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS


In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS


Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION


Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING


National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7']
1669,32482147,Comparative measurement properties of constant work rate cycling and the endurance shuttle walking test in COPD: the TORRACTO ®  clinical trial.,"BACKGROUND


Exercise tolerance is an important endpoint in chronic obstructive pulmonary disease (COPD) clinical trials. Little is known about the comparative measurement properties of constant work rate cycle ergometry (CWRCE) and the endurance shuttle walking test (ESWT). The objective of this sub-analysis of the TORRACTO ®  study was to directly compare the endurance measurement properties of CWRCE and ESWT in patients with COPD in a multicentre, multinational setting. We predicted that both tests would be similarly reliable, but that the ESWT would be more responsive to bronchodilation than CWRCE.
METHODS


This analysis included 151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily placebo, tiotropium/olodaterol (T/O) 2.5/5 μg or T/O 5/5 μg. Reproducibility was assessed by comparing their respective performance at baseline and week 6 in the placebo group. Responsiveness to bronchodilation was assessed by comparing endurance time at week 6 with T/O with baseline values and placebo. The locus of symptom limitation and end-exercise Borg scales for breathing and leg discomfort for both tests were also analysed.
RESULTS


The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84). More patients were limited by breathing discomfort during the ESWT than during CWRCE, whereas more patients were limited by leg discomfort or breathing/leg discomfort during CWRCE than the ESWT ( p  <0.0001). Both tests were responsive to bronchodilator treatment: there was a 19% increase in endurance time from baseline at week 6 ( p  = 0.0006) assessed with CWRCE, and a 20% increase in endurance time assessed with ESWT ( p  = 0.0013).
CONCLUSIONS


Both exercise tests performed well in a multicentre clinical trial. Although the locus of symptom limitation differed between the two tests, both were reliable and responsive to bronchodilation. For future clinical trials, the choice of test should depend on the study requirements.
CLINICALTRIALS.GOV IDENTIFIER


NCT01525615.  The reviews of this paper are available via the supplemental material section.",2020,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"['chronic obstructive pulmonary disease (COPD', 'patients with COPD in a multicentre, multinational setting', 'COPD', '151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily']","['ESWT', 'endurance shuttle walking test', 'placebo, tiotropium/olodaterol (T/O) 2.5/5\u2009μg or T', 'placebo']","['endurance time assessed with ESWT', 'endurance time', 'Reproducibility', 'leg discomfort or breathing/leg discomfort', 'breathing discomfort']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0859235', 'cui_str': 'Leg discomfort'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",151.0,0.220765,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Research Centre, Institut universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, G1V 4G5, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'Medical Department, Boehringer Ingelheim, Burlington, ON, Canada.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Rehabilitation Clinical Trial Centre, Los Angeles Biomedical Research Institute at Harbour-UCLA Medical Centre, Torrance, CA, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926858']
1670,31042420,Impact of Consensus Molecular Subtype on Survival in Patients With Metastatic Colorectal Cancer: Results From CALGB/SWOG 80405 (Alliance).,"PURPOSE


To determine the predictive and prognostic value of the consensus molecular subtypes (CMSs) of colorectal cancer (CRC) that represent a merging of gene expression-based features largely in primary tumors from six independent classification systems and provide a framework for capturing the intrinsic heterogeneity of CRC in patients enrolled in CALGB/SWOG 80405.
PATIENTS AND METHODS


CALGB/SWOG 80405 is a phase III trial that compared the addition of bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan as first-line treatment of advanced CRC. We characterized the CMS classification using a novel NanoString gene expression panel on primary CRCs from 581 patients enrolled in this study to assess the prognostic and predictive value of CMSs in these patients.
RESULTS


The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001). Furthermore, CMSs were predictive for both OS ( P  for interaction < .001) and PFS ( P  for interaction = .0032). In the CMS1 cohort, patients treated with bevacizumab had a significantly longer OS than those treated with cetuximab ( P  < .001). In the CMS2 cohort, patients treated with cetuximab had a significantly longer OS than patients treated with bevacizumab ( P  = .0046).
CONCLUSION


These findings highlight the possible clinical utility of CMSs and suggests that refinement of the CMS classification may provide a path toward identifying patients with metastatic CRC who are most likely to benefit from specific targeted therapy as part of the initial treatment.",2019,The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001).,"['581 patients enrolled', 'patients with metastatic CRC', 'advanced CRC', 'Patients With Metastatic Colorectal Cancer']","['cetuximab', 'bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan', 'bevacizumab']","['longer OS', 'PFS', 'progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",581.0,0.0554368,The CMSs are highly prognostic for overall survival (OS;  P  < .001) and progression-free survival (PFS;  P  < .001).,"[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': '1University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': '3University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': '4Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': '5Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': '6West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': '7Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""8Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': '9Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': '10Genentech, San Francisco, CA.'}, {'ForeName': 'Pratyaksha', 'Initials': 'P', 'LastName': 'Wirapati', 'Affiliation': '11Swiss Institute of Bioinformatics, Lausanne, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': '12Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': '13The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kabbarah', 'Affiliation': '10Genentech, San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02258']
1671,32581121,Toward a science of delivering aid with dignity: Experimental evidence and local forecasts from Kenya.,"How can governments and nonprofits design aid programs that afford dignity and facilitate beneficial outcomes for recipients? We conceptualize dignity as a state that manifests when the stigma associated with receiving aid is countered and recipients are empowered, both in culturally resonant ways. Yet materials from the largest cash transfer programs in Africa predominantly characterize recipients as needy and vulnerable. Three studies examined the causal effects of alternative aid narratives on cash transfer recipients and donors. In study 1, residents of low-income settlements in Nairobi, Kenya ( N =  565) received cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative. They then chose whether to spend time building business skills or watching leisure videos. Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma. Given the diverse settings in which aid is delivered, how can organizations quickly identify effective narratives in a context? We asked recipients to predict which narrative would best motivate skill-building in their community. In study 2, this ""local forecasting"" methodology outperformed participant evaluations and experimental pilots in accurately ranking treatments. Finally, study 3 confirmed that the narrative most effective for recipients did not undermine donors' willingness to contribute to the program. Together these studies show that responding to recipients' psychological and sociocultural realities in the design of aid can afford recipients dignity and help realize aid's potential.",2020,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","['residents of low-income settlements in Nairobi, Kenya ( N =  565) received']","['dignity', 'cash-based aid accompanied by a randomly assigned narrative: the default deficit-focused ""Poverty Alleviation"" narrative, an ""Individual Empowerment"" narrative, or a ""Community Empowerment"" narrative']",['self-efficacy and anticipated social mobility'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0181758,"Both empowerment narratives improved self-efficacy and anticipated social mobility, but only the ""Community Empowerment"" narrative significantly motivated recipients' choice to build skills and reduced stigma.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Otis', 'Affiliation': 'Division of Health Policy and Management, University of California, Berkeley, CA 94720.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Abraham', 'Affiliation': 'Department of Economics, University of California, San Diego, CA 92161.'}, {'ForeName': 'Hazel Rose', 'Initials': 'HR', 'LastName': 'Markus', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305; ccthomas@stanford.edu hmarkus@stanford.edu.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1917046117']
1672,32580300,Changes in the Bristle Stiffness of Polybutylene Terephthalate Manual Toothbrushes over 3 Months: A Randomized Controlled Trial.,"We previously reported that polybutylene terephthalate (PBT) toothbrushes become less effective for plaque removal after two months of use. However, it remains unknown how the bristle stiffness of PBT toothbrushes changes after several months of use. We performed a single-center randomized controlled trial to evaluate the bristle stiffness and bristle splaying of soft and medium manual toothbrushes among dental and medical students of Hiroshima University. Subjects were 80 participants who met the criteria. Participants were randomly assigned to the soft toothbrush group (n = 40) or the medium toothbrush group (n = 40). We collected toothbrushes immediately after first use (T0), after one month of use (T1), after two months of use (T2), and after three months of use (T3). Bristle stiffness was measured according to the International Organization for Standardization (ISO) 22254. The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium; 4.33 vs. 4.52, P < 0.05, respectively, and T3 vs. T0, 3.62 vs. 3.89,  p  < 0.01 and 4.18 vs. 4.52,  p  < 0.001, respectively). Bristle stiffness was significantly reduced in soft and medium PBT toothbrushes after two months of use.",2020,"The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium;","['Subjects were 80 participants who met the criteria', 'dental and medical students of Hiroshima University']","['soft and medium manual toothbrushes', 'polybutylene terephthalate (PBT) toothbrushes', 'medium toothbrush group']","['mean bristle stiffness', 'Bristle stiffness']","[{'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0071364', 'cui_str': 'poly(1,4-butylene terephthalate)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",80.0,0.0593318,"The mean bristle stiffness (N/cm 2 ) of soft and medium toothbrushes was significantly lower at T2 and T3 than at T0 (T2 vs. T0, soft; 3.63 vs. 3.89, P < 0.01 and medium;","[{'ForeName': 'Yoshino', 'Initials': 'Y', 'LastName': 'Kaneyasu', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Shigeishi', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Ohta', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Public Oral Health, Program of Oral Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}]","Materials (Basel, Switzerland)",['10.3390/ma13122802']
1673,32580480,Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes.,"BACKGROUND


The study of injuries stemming from sacroiliac dysfunction in athletes has been discussed in many papers. However, the treatment of this issue through thrust and muscle-energy techniques has hardly been researched. The objective of our research is to compare the effectiveness of thrust technique to that of energy muscle techniques in the resolution of sacroiliac joint blockage or dysfunction in middle-distance running athletes.
METHODS


A quasi-experimental design with three measures in time (pre-intervention, intervention 1, final intervention after one month from the first intervention) was made. The sample consisted of 60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction. The sample was randomly divided into three groups of 20 participants (43 men and 17 women). One intervention group was treated with the thrust technique, another intervention group was treated with the muscle-energy technique, and the control group received treatment by means of a simulated technique. A prior assessment of the range of motion was performed by means of a seated forward flexion test, a standing forward flexion test, and the Gillet test. After observing the dysfunction, the corresponding technique was performed on each intervention group. The control group underwent a simulated technique. A second intervention took place a month later, in order to ascertain possible increased effectiveness.
RESULTS


Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention). Comparing the changes in time, only the thrust group obtained statistically significant differences ( p  = 0.000, with a reduction of positive dysfunction, starting at 20 positives, five positive in the initial intervention and two positive in the final intervention) and when comparing both techniques, it was observed that between the first intervention and the final intervention, the thrust technique was significantly higher than the MET technique ( p  = 0.032).
CONCLUSIONS


The thrust manipulation technique is more effective in the treatment of sacroiliac dysfunction than the energy muscle technique, in both cases obtaining satisfactory results with far middle-distance running athletes. Finally, the thrust technique showed positive results in the first intervention and also in the long term, in contrast to the MET technique that only obtained changes after the first intervention.",2020,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","['Sacroiliac Joint Dysfunction in Athletes', '60 adult athletes from an Athletic club, who were dealing with sacroiliac joint dysfunction', '20 participants (43 men and 17 women', 'middle-distance running athletes']","['simulated technique', 'Muscle Energy Technique versus Osteopathic Manipulation', 'placebo']",['positive dysfunction'],"[{'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",60.0,0.0131154,"Statistically significant differences were found between the muscle energy technique (MET) and muscle energy groups compared with the placebo group in both interventions ( p  = 0.000), with a significant reduction in positive dysfunction (initially 20 in all groups, eight in MET group, and two in thrust group in the final intervention).","[{'ForeName': 'Urko José', 'Initials': 'UJ', 'LastName': 'García-Peñalver', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Palop-Montoro', 'Affiliation': 'Facultad de Fisioterapia, Universidad Católica de San Antonio (UCAM), Av. de los Jerónimos, 135, 30107 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manzano-Sánchez', 'Affiliation': 'Facultad de Ciencias del Deporte, Universidad de Murcia, Calle Argentina, 19, 30720 San Javier, Murcia Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124490']
1674,32585338,Targeting T cells in inflammatory bowel disease.,"T cells play a pivotal role in the immune response underlying inflammatory bowel disease (IBD) pathogenesis. On this basis, over the past 25 years several drugs have assessed to target T cells in IBD patients. Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only. The anti-CD4 BF-5 and cM-T412, and the anti-CD25 basiliximab and daclizumab were not effective in CD and UC patients, respectively. The anti-NKG2D antibody NNC0142-0002 showed clinical benefit in CD patients, in particular in biologic naïve ones, in a randomized, double-blind, parallel-group, placebo-controlled trial. The anti-CD40L M90 and the GSK1349571A blocking calcium release-activated calcium (CRAC) channels, which are involved in the T cell activation and proliferation, were tested only in ex vivo/in vitro experiments. Apart from ustekinumab, all the other drugs targeting T cell-derived cytokines failed. The reinduction of lamina propria T cell apoptosis is a mechanism to modulate T cell survival exploited by cyclosporin A, azathioprine and anti-tumor necrosis factor-α agents, such as infliximab, adalimumab and golimumab. In this article, we review the drugs targeting T cells via surface receptors, via T cell-derived cytokines, via CRAC channels or by inducing apoptosis.",2020,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[""ulcerative colitis (UC) and Crohn's disease (CD) patients""]","['cyclosporin A, azathioprine', 'daclizumab', 'placebo']",[],"[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0961703,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giuffrida', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Sabatino', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address: a.disabatino@smatteo.pv.it.'}]",Pharmacological research,['10.1016/j.phrs.2020.105040']
1675,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
1676,32585392,"Randomized, double-blind, placebo-controlled clinical trial studying the effects of Turmeric in combination with mefenamic acid in patients with primary dysmenorrhoea.","Primary dysmenorrhea (PDM) is one of the common complaints in women. This study aimed to assess the effects of turmeric and mefenamic acid and a combination compared with placebo on PDM. This clinical trial was conducted on dormitory students with PDM. Subjects completed the visual analog scale (VAS) before randomization. One hundred twenty-eight patients, randomly assigned to one of following groups: Turmeric group (n=32), mefenamic acid group (n=32), turmeric and mefenamic acid group (n=32), and placebo group (n=32). Turmeric and mefenamic acid were administrated in 500mg and 250mg, respectively. Pain severity was assessed in the baseline and the end line by VAS. Statistical analysis was performed using SPSS software. The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups. Our results illustrated that combination of turmeric and mefenamic acid would be better in pain alleviation in PDM.",2020,"The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups.","['dormitory students with PDM', 'One hundred twenty-eight patients', 'patients with primary dysmenorrhoea']","['turmeric and mefenamic acid', 'mefenamic acid', 'Turmeric and mefenamic acid', 'placebo']","['visual analog scale (VAS', 'Pain severity', 'Primary dysmenorrhea (PDM', 'pain alleviation', 'alleviated pain']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}]",,0.179814,"The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups.","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Hesami', 'Affiliation': 'Student Research Committee, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kavianpour', 'Affiliation': 'Department of Tissue Engineering and Applied Cell Sciences, Faculty of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Rashidi Nooshabadi', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Lalooha', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khadem Haghighian', 'Affiliation': 'Student Research Committee, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran; Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: khademnut@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101840']
1677,32585438,Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.,"PURPOSE


To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness.
MATERIALS AND METHODS


A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RF CSA ) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission.
RESULTS


Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
CONCLUSIONS AND RELEVANCE


In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials.
TRIAL REGISTRATION


anzctr.org.au Identifier: ACTRN12616000948493.",2020,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","['72 participants (mean age, 56-years; male, 68%) who completed the study', 'critically ill adults', 'Critically ill patients expected to be mechanically ventilated for at least 48\xa0h']","['anzctr.org.au Identifier', '30\xa0min daily in-bed cycling in addition to usual-care physiotherapy (n\xa0=\xa037) or usual-care physiotherapy', 'bed cycling']","['quality of life', 'manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission', 'muscle atrophy of rectus femoris cross-sectional area (RF CSA ', 'muscle atrophy of RF CSA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}]",,0.450536,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: scott.king@health.qld.gov.au.'}, {'ForeName': 'Nicolette E', 'Initials': 'NE', 'LastName': 'Gale', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: nicolette.gale@health.qld.gov.au.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: alicia.bowen@health.qld.gov.au.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Peel', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: brent.peel@health.qld.gov.au.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Donaldson', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: samuel.donaldson2@health.qld.gov.au.'}, {'ForeName': 'Stewart T J', 'Initials': 'STJ', 'LastName': 'Mealing', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: stewart.mealing@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Journal of critical care,['10.1016/j.jcrc.2020.05.008']
1678,32588401,Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial.,"BACKGROUND


Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, improved wakefulness and reduced excessive daytime sleepiness (EDS) in studies of participants with narcolepsy with and without cataplexy.
OBJECTIVE


Prespecified subgroup analyses of data from a 12-week randomized, double-blind, placebo-controlled, phase III trial of solriamfetol for EDS in narcolepsy evaluated the efficacy and safety of solriamfetol by cataplexy status.
METHODS


Participants with narcolepsy received solriamfetol (75, 150, or 300 mg/day) or placebo and were stratified by cataplexy status. Coprimary endpoints were change from baseline on Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C) was the key secondary endpoint. Change in frequency of cataplexy attacks was evaluated in participants reporting cataplexy at baseline. Safety was evaluated. No adjustments were made for multiple comparisons; therefore p values are nominal.
RESULTS


There were 117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup. At week 12, least-squares (LS) mean (95% confidence interval [CI]) differences from placebo on change from baseline in MWT for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were 1.6 (- 3.6 to 6.9), 6.1 (0.7-11.4), and 8.9 (3.5-14.2) minutes, respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup were 3.4 (- 1.9 to 8.7), 9.1 (3.8-14.3), and 11.2 (5.8-16.6) minutes, respectively (p < 0.001; 150 and 300 mg). At week 12, LS mean (95% CI) differences from placebo on ESS change from baseline for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were - 1.3 (- 3.9 to 1.3), - 3.7 (- 6.4 to - 1.1), and - 4.5 (- 7.1 to - 1.9), respectively (p < 0.01; 150 and 300 mg), and in the non-cataplexy subgroup were - 3.0 (- 5.6 to - 0.4), - 3.7 (- 6.3 to - 1.2), and - 4.9 (- 7.6 to - 2.2), respectively (p < 0.05; all doses). For PGI-C at week 12, the mean percentage difference from placebo (95% CI) for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup was 10% (- 15 to 35), 33% (9-57), and 39% (16-61), respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup was 48% (25-70), 44% (21-67), and 52% (30-73), respectively (p < 0.001; all doses), with somewhat differential treatment effects for 75 mg by cataplexy status. No changes in the number of cataplexy attacks were observed for solriamfetol compared with placebo (mean ± standard deviation changes: - 3.6 ± 13.3 [combined solriamfetol] and - 3.5 ± 9.8 [placebo]). Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
CONCLUSIONS


These data strongly indicate that solriamfetol was effective in treating EDS in participants with narcolepsy with or without cataplexy, as indicated by robust effects on MWT, ESS, and PGI-C. The safety profile was similar regardless of cataplexy status.
TRIAL REGISTRATION AND DATE


ClinicalTrials.gov NCT02348593. 28 January 2015.",2020,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
","['117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup', 'participants with narcolepsy with and without cataplexy', 'Participants with Narcolepsy with and without Cataplexy', 'Participants with narcolepsy received solriamfetol (75, 150, or 300\xa0mg/day) or', 'participants with narcolepsy with or without cataplexy', '28 January 2015']",['placebo'],"['Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis', 'number of cataplexy attacks', 'Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C', 'excessive daytime sleepiness (EDS', 'ESS change', 'Excessive Daytime Sleepiness', 'frequency of cataplexy attacks']","[{'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0303405', 'cui_str': 'Indium-114'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.426224,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Département de Neurologie, Centre National de Référence Narcolepsie Hypersomnies Inserm U1061, CHU Gui-de-Chauliac, University of Montpellier, 80, Avenue Augustin Fliche, 34295, Montpellier Cedex 5, France. y-dauvilliers@chu-montpellier.fr.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'UHN-Toronto Western Hospital, University of Toronto, 399 Bathurst St, MP7, 421, Medical Sciences, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schimmelpfengstraße 6, 34613, Schwalmstadt, Germany.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, 5454 Wisconsin Ave, Suite 1725, Chevy Chase, MD, 20815, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Montefiore Medical Center, 111 East 210th Street, Bronx, NY, 10467-2509, USA.'}]",CNS drugs,['10.1007/s40263-020-00744-2']
1679,32589857,Relationship between interleukin-13 rs20541 single nucleotide polymorphisms and therapeutic efficacy in children with asthma.,"OBJECTIVE


To investigate the relationship between therapeutic efficacy in children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms.
METHODS


Fifty children with moderate-to-severe asthma were assigned to the GG, GA, and AA groups according to the IL-13 gene locus rs20541 polymorphism. The patients received budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation. The improvement of clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions were observed.
RESULTS


Lung function did not significantly differ among three groups before treatment. After treatment, the time to symptom relief was significantly shorter in the GG group than that in the other two groups. The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups.
CONCLUSION


Budesonide inhalation suspension combined with fluticasone propionate is an effective treatment regimen for moderate-to-severe asthma. Polymorphism of the IL-13 rs20541 locus may be correlated with therapeutic efficacy. Patients carrying the GG allele were more responsive than their counterparts with the GA or AA allele.",2020,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups.
","['moderate-to-severe asthma', 'children with asthma', 'children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms', 'Fifty children with moderate-to-severe asthma']","['budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation', 'fluticasone propionate']","['time to symptom relief', 'clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions', 'forced expiratory volume', 'Lung function', 'peak expiratory flow']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C4745751', 'cui_str': 'Budesonide Inhalation Suspension'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0425449', 'cui_str': 'Gasping for breath'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",50.0,0.0209337,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups.
","[{'ForeName': 'Lixiao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Yue', 'Affiliation': 'Jinan Maternity and Child Care Hospital, Shandong, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520929179']
1680,32590726,Prediction of no-reflow phenomenon in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.,"No-reflow is an important complication among patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing direct PCI was performed. Patients were randomly assigned at a 7:3 ratio into development cohort and validation cohort and into no-reflow and normal blood flow groups. Clinical data and laboratory examinations were compared to identify independent risk factors and establish a no-reflow risk scoring system.In the development cohort (n = 1122), 331 (29.5%) had no-reflow. Multivariate analysis showed age ≥ 65 years (OR = 1.766, 95% confidence interval (CI): 1.313-2.376, P < .001), not using angiotonase inhibitor/angiotensin receptor antagonists (OR = 1.454, 95%CI: 1.084-1.951, P = .013), collateral circulation <grade 2 (OR = 3.056, 95%CI: 1.566-5.961, P = .001), thrombosis burden ≥4 points (OR = 2.033, 95%CI: 1.370-3.018, P < .001), diameter of target lesion ≥3.5 mm (OR = 1.511, 95%CI: 1.087-2.100, P = .014), thrombosis aspiration (OR = 1.422, 95%CI: 1.042-1.941, P = .026), and blood glucose >8 mmol/L (OR = 1.386, 95%CI: 1.007-1.908, P = .045) were related to no-reflow. Receiver operating characteristic (ROC) area under the curve was 0.648 (95%CI: 0.609-0.86). At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%, P < .001. The resulting risk scoring system was tested in the validation cohort (n = 536), with 30.1% incidence of no-reflow. The area under the ROC curve was 0.637 (95%CI: 0.582-0.692). At a cutoff of 0.349 sensitivity was 53.2% and specificity was 66.7%, PPV was 41.2%, NPV was 76.4%, P < .001.The no-reflow risk scoring system was effective in identifying high-risk patients.",2020,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","['patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction', 'patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing']",['direct PCI'],"['positive predictive value (PPV', 'risk scoring system', 'thrombosis aspiration', 'negative predictive value (NPV', 'Receiver operating characteristic (ROC) area under the curve', 'collateral circulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}]",1658.0,0.10574,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Tianjin Medical University.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Thoracic Clinical College, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}]",Medicine,['10.1097/MD.0000000000020152']
1681,32590780,Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra.,"BACKGROUND


Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises.
METHODS


For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention.
RESULTS


The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences.
CONCLUSIONS


This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR.
TRIAL REGISTRATION


This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.",2020,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","['90 patients with CSR', 'patients with radiculopathy of cervical vertebra', 'patients with CSR']","['control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises', 'five-step exercises']","['recovery rate', 'Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263854', 'cui_str': 'Cervical arthritis'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",90.0,0.0298168,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Lingge', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Lanzhou University, Lanzhou, Gansu, China.'}]",Medicine,['10.1097/MD.0000000000020846']
1682,32595783,Effect of Mindfulness-Based Relapse Prevention on Impulsivity Trajectories Among Young Adults in Residential Substance Use Disorder Treatment.,"Objectives


Impulsivity has been identified as an important construct in predicting the initiation and maintenance of substance use among at-risk populations. Interventions emphasizing mindfulness strategies appear particularly promising in reducing substance use and marking change in various aspects of impulsivity.
Methods


The current study used a rolling group mindfulness-based relapse prevention (MBRP) intervention for young adults in residential substance use disorder treatment. We examined change in impulsivity facets measured by the S-UPPS for youth randomly assigned to MBRP ( n  = 45) versus those assigned to treatment as usual plus 12 step/self-help ( n  = 34). We also examined how change in impulsivity mediated changes in substance use post-treatment.
Results


In general, results indicated that MBRP is effective at reducing facets of trait impulsivity in treatment-seeking individuals with SUDs. Only positive and negative urgency mediated the relation between treatment assignment and substance use.
Conclusions


MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity. Both positive and negative urgency were significant mechanisms of change in reducing substance use following treatment. Results are discussed focused on the utility of MRBP as a clinical intervention for at-risk, marginalized, and young adults.",2019,"Conclusions


MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity.","['young adults in residential substance use disorder treatment', 'Young Adults in Residential Substance Use Disorder Treatment', 'young adults']","['MRBP', 'Mindfulness-Based Relapse Prevention', 'MBRP', 'rolling group mindfulness-based relapse prevention (MBRP) intervention']","['Impulsivity Trajectories', 'trait impulsivity', 'impulsivity facets']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}]",,0.0290944,"Conclusions


MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity.","[{'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Davis', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Barr', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Dworkin', 'Affiliation': 'Center for the Study of Health and Risk Behaviors, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Dumas', 'Affiliation': 'Department of Psychology, Huron University College at Western University, London, ON, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Berey', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'DiGuiseppi', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Rael Cahn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Brain and Creativity Institute, USC Center for Mindfulness Science, University of Southern California, Los Angeles, CA, USA.'}]",Mindfulness,['10.1007/s12671-019-01164-0']
1683,32601915,Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza.,"Baloxavir marboxil (Xofluza ® ; hereafter referred to as baloxavir), the prodrug of baloxavir acid, is a first-in-class, small molecule inhibitor of the polymerase acidic (PA) protein subunit of the influenza virus polymerase complex. Baloxavir (after conversion to baloxavir acid) acts to block influenza virus replication by inhibiting the cap-dependent endonuclease activity of the PA protein. Taken orally as a single dose, baloxavir is approved in the USA for the treatment of acute uncomplicated influenza in patients ≥ 12 years of age who have been symptomatic for ≤ 48 h. Data from randomized, double-blind, placebo- and oseltamivir-controlled phase III trials have shown that baloxavir is efficacious in improving influenza symptoms both in otherwise healthy adolescents and adults and in those at high risk of influenza complications, displaying similar efficacy to that of oseltamivir. Furthermore, there is evidence that baloxavir can reduce influenza viral load more rapidly than oseltamivir. Baloxavir has activity against influenza A and B viruses (including strains resistant to neuraminidase inhibitors) and is well tolerated. Evidence of the emergence and likely human-to-human transmission of variant viruses with reduced susceptibility to baloxavir highlights the importance of monitoring and surveillance for changes in influenza virus drug susceptibility patterns. However, currently available evidence suggests that baloxavir, with the benefits of a single oral dose regimen, provides a useful alternative to neuraminidase inhibitors for the treatment of acute uncomplicated influenza in adolescents and adults.",2020,Baloxavir has activity against influenza ,"['acute uncomplicated influenza in adolescents and adults', 'acute uncomplicated influenza in patients ≥\xa012\xa0years of age who have been symptomatic for ≤\xa048']","['Baloxavir', 'baloxavir', 'Baloxavir Marboxil', 'Baloxavir marboxil (Xofluza ® ', 'placebo- and oseltamivir-controlled phase']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C4734327', 'cui_str': 'Xofluza'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],,0.105801,Baloxavir has activity against influenza ,"[{'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Shirley', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01350-8']
1684,32602803,Participant Satisfaction and Acceptability of a Culturally Adapted Brief Intervention to Reduce Unhealthy Alcohol Use Among Latino Immigrant Men.,"Latino immigrant men are at increased risk for unhealthy alcohol use, yet few interventions have been designed to meet their unique needs. The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population. Adaptations to the brief intervention included delivering it in Spanish by  promotores  in a community setting. The mixed methods approach included surveys ( N  = 73) and in-depth interviews ( N  = 20) with participants in a pilot randomized controlled trial. The study drew on Sekhon's theoretical framework of acceptability to asses affective attitude, burden, and perceived effectiveness of the intervention, along with satisfaction with the content, setting, and  promotor . Participants' survey responses indicated that they were highly satisfied with the content, setting, and delivery of the brief intervention. In interviews participants noted that the brief intervention helped them reflect on their drinking behaviors, that they perceived  promotores  to be a trusted source of health information, and that they liked receiving personalized feedback via tablets. Some participants found the feedback did not match their own perceptions of their alcohol use and wanted clearer advice on how to reduce their drinking. Men felt they would benefit from more contact with  promotores . These findings suggest that Latino immigrant men in this study were receptive to the culturally adapted brief intervention. Future interventions may be more effective if they include multiple contacts with  promotores  and more directive guidance on strategies to reduce drinking.",2020,The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population.,"['Latino Immigrant Men', 'Latino immigrant men']",['Culturally Adapted Brief Intervention to Reduce Unhealthy Alcohol Use'],[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",[],,0.0241914,The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population.,"[{'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Torres', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Ceballos', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}]",American journal of men's health,['10.1177/1557988320925652']
1685,32485328,Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design.,"BACKGROUND


Previous studies have implied the efficacy and safety of argatroban plus recombinant tissue-type plasminogen activator (r-tPA) in patients with acute ischemic stroke. Further trials are needed to establish convincing conclusions in a large sample size.
RESEARCH DESIGN AND METHODS


Argatroban plus r-tPA for Acute Ischemic Stroke (ARAIS) trial is a multicenter, prospective, randomized, open-label, and blind-end point trial. The trial proposes to randomize 808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5 hours of symptom onset to receive argatroban (100 μg/kg bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours) plus r-tPA or r-tPA alone. The primary end point is the proportion of patients with an excellent outcome of no clinically significant residual stroke deficits (modified Rankin scale 0-1) at 90 days. Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days. Safety end points include symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding.
CONCLUSION


ARAIS trial will evaluate whether argatroban plus r-tPA is superior to r-tPA alone in improving functional outcomes in acute ischemic stroke patients in a large sample population.",2020,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","['acute ischemic stroke (ARAIS', 'acute ischemic stroke patients in a large sample population', '808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5\u202fhours of symptom onset to receive', 'patients with acute ischemic stroke']","['argatroban plus recombinant tissue-type plasminogen activator (r-tPA', 'argatroban plus r-tPA', 'argatroban plus recombinant tissue-type plasminogen activator', 'Argatroban plus r-tPA', 'argatroban (100\u202fμg/kg bolus followed by an infusion of 1.0\u202fμg/kg per minute for 48\u202fhours) plus r-tPA or r-tPA alone']","['stroke recurrence or other vascular events', 'symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding', 'NIHSS score', 'proportion of patients with a good outcome (modified Rankin scale 0-2) at 90\u202fdays, early neurological improvement (NIHSS score\u202f≥2-point decrease) at 48\u202fhours, early neurological deterioration (NIHSS score\u202f≥4-point increase', 'functional outcomes', 'proportion of patients with an excellent outcome of no clinically significant residual stroke deficits']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",808.0,0.128243,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhonghe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China. Electronic address: chszh@aliyun.com.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: yilong528@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.003']
1686,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND


Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking.
RESEARCH QUESTION


Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters.
METHODS


This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments.
RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain.
SIGNIFICANCE


This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030']
1687,32583707,"Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.","The purpose of this pilot randomized controlled trial is to assess the feasibility and impact of a triweekly 12-week yoga intervention among people living with HIV (PLWH). Additional objectives included evaluating cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health among yoga participants versus controls using blinded assessors. We recruited 22 medically stable PLWH aged ≥35 years. A priori feasibility criteria were ≥70% yoga session attendance and ≥70% of participants satisfied with the intervention using a postparticipation questionnaire. Two participants withdrew from the yoga group. Mean yoga class attendance was 82%, with 100% satisfaction. Intention-to-treat analyses (yoga n = 11, control n = 11) showed no within- or between-group differences in cognitive and physical function. The yoga group improved over time in HRQoL cognition ( P  = .047) with trends toward improvements in HRQoL health transition ( P  =.063) and depression ( P  = .055). This pilot study provides preliminary evidence of feasibility and benefits of yoga for PLWH.",2020,The yoga group improved over time in HRQoL cognition ( P  = .047) with trends toward improvements in HRQoL health transition ( P  =.063) and depression ( P  = .055).,"['22 medically stable PLWH aged ≥35 years', 'People Living with HIV', 'people living with HIV (PLWH']","['Yoga Intervention', 'yoga intervention']","['Mean yoga class attendance', 'cognitive and physical function', 'HRQoL health transition', 'Cognition, Physical Function, Physical Activity, and Affective Outcomes', 'time in HRQoL cognition', 'cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health', 'depression']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376627', 'cui_str': 'Health Transition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",22.0,0.106207,The yoga group improved over time in HRQoL cognition ( P  = .047) with trends toward improvements in HRQoL health transition ( P  =.063) and depression ( P  = .055).,"[{'ForeName': 'Adria', 'Initials': 'A', 'LastName': 'Quigley', 'Affiliation': 'Department of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Brouillette', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Gahagan', 'Affiliation': 'School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Kelly Kathleen', 'Initials': 'KK', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Physiotherapy, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'MacKay-Lyons', 'Affiliation': 'Department of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958220935698']
1688,31843232,Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).,"Little data are available regarding the determinants and prognostic significance of serum albumin in Heart Failure with Preserved Ejection Fraction (HFpEF). We sought to examine the phenotypic correlates of albumin and its independent prognostic implications in HFpEF. We analyzed data from 3,254 subjects enrolled the TOPCAT trial. We stratified subjects according to tertiles of albumin and examined differences in various phenotypic traits between these strata, including 8 protein biomarkers selected ad hoc and measured from frozen samples available in a subset of participants (n = 372). We also assessed the relationship between albumin and the trial primary endpoint. Lower albumin was associated with older age, black race, and greater prevalence of NYHA class III-IV, peripheral arterial disease, atrial fibrillation and diabetes mellitus. Lower albumin was also associated with increased levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension. Albumin was a strong predictor of the primary trial endpoint, even after adjustment for the MAGGIC risk score (hazard ratio [HR] 0.72, confidence interval [CI] 0.67 to 0.78; p <0.0001) and prespecified traditional risk factors (HR 0.78, CI 0.71 to 0.85; p <0.0001). Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease. Albumin is a powerful risk predictor independent of traditional risk prediction models, even within normal ranges.",2020,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","['3,254 subjects enrolled the TOPCAT trial', 'Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial']",[],"['levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension', 'Serum Albumin Levels']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",3254.0,0.0639009,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Prenner', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cvijic', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spires', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Yarde', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Bhattacharya', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Zamani', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Mazurek', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gordon', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.006']
1689,32585914,Behavior Change Following Pain Neuroscience Education in Middle Schools: A Public Health Trial.,"Chronic pain and the opioid epidemic need early, upstream interventions to aim at meaningful downstream behavioral changes. A recent pain neuroscience education (PNE) program was developed and tested for middle-school students to increase pain knowledge and promote healthier beliefs regarding pain. In this study, 668 seventh-grade middle-school students either received a PNE lecture ( n  = 220); usual curriculum school pain education (UC) ( n  = 198) or PNE followed by two booster (PNEBoost) sessions ( n  = 250). Prior to, immediately after and at six-month follow-up, pain knowledge and fear of physical activity was measured. Six months after the initial intervention school, physical education, recess and sports attendance/participation as well as healthcare choices for pain (doctor visits, rehabilitation visits and pain medication use) were measured. Students receiving PNEBoost used 30.6% less pain medication in the last 6 months compared to UC ( p  = 0.024). PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p  = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p  = 0.004). In conclusion, PNEBoost yielded more positive behavioral results in middle school children at six-month follow-up than PNE and UC, including significant reduction in pain medication use.",2020,PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p  = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p  = 0.004).,"['middle school children', ' n  = 220', 'Middle Schools', 'middle-school students', '668 seventh-grade middle-school students either received a']","['usual curriculum school pain education (UC) ( n  = 198) or PNE followed by two booster (PNEBoost) sessions', 'PNE lecture']","['Chronic pain', 'positive behavioral results', 'pain medication', 'pain knowledge and fear of physical activity']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",668.0,0.0223239,PNEBoost was superior to PNE for rehabilitation visits in students experiencing pain ( p  = 0.01) and UC for attending school in students who have experienced pain > 3 months ( p  = 0.004).,"[{'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Louw', 'Affiliation': 'Evidence in Motion, Story City, IA 50248, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Landrus', 'Affiliation': 'Big Stone Therapies, Hendricks, MN 56136, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Podolak', 'Affiliation': 'Evidence in Motion Pain Fellowship, San Antonio, TX 78232, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Benz', 'Affiliation': 'Confluent Health, Siesta Key, FL 34242, USA.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'DeLorenzo', 'Affiliation': '180 Therapy and Wellness, Alexandria, VA 22314, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'St. Croix Regional Medical Center, St Croix Falls, WI 54024, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'SERC Physical Therapy, Webb City, MO 64870, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Physical Therapy of Concordia, Concordia, MO 64020, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Ortho Spine and Pain Clinic, Story City, IA 50248, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, University of South Dakota, Vermillion, SD 57069, USA.'}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Puentedura', 'Affiliation': 'Doctor of Physical Therapy Program, Robbins College of Health and Human Sciences, Baylor University, Waco, TX 76798-7303, USA.'}, {'ForeName': 'Merrill R', 'Initials': 'MR', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154-3029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124505']
1690,32585923,A Process Evaluation Protocol for Examining the Impact of Instructions for Correct Use of Child Car Seats Designed through a Consumer-Driven Process and Evaluated in a Field-Based Randomised Controlled Trial.,"The incorrect use of child car seats is common, with significant negative effects on crash protection for child passengers. There is currently little evidence for effective, practical countermeasures for incorrect use. The provision of clear and comprehensible materials on correct use supplied with restraints at the point of sale could be highly cost-effective and achieve similar benefits to restraint-fitting services or hands-on training; however, routinely supplied instructions in their current form are frequently difficult to understand. We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos. This paper presents the protocol that will be used in an innovate process evaluation that will use the primary outcome of overall serious misuse assessed at six months, together with a survey and semi-structured interviews to determine fidelity, dose and outcomes for all intervention participants. The study will assess intervention delivery and external factors that may impact the effectiveness of the intervention, including experience, health literacy, confidence and attitudes. When it has been conducted, this process evaluation will provide enhanced understanding of the mechanisms through which the intervention works or not, aspects of the implementation process key to success of the intervention and insight into how external factors influence the success of the intervention.",2020,"We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos.",[],[],[],[],[],[],,0.054456,"We are conducting a randomised controlled trial of the consumer-driven redesign of instructional materials, consisting of an instruction sheet, swing tags and online training videos.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Elkington', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Charlton', 'Affiliation': 'Monash University Accident Research Centre, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Bilston', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and Faculty of Medicine, University of New South Wales, Sydney 2031, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'School of Public Health, University of Technology Sydney, Sydney 2007, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney 2042, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17124508']
1691,32585974,Wheatgrass Juice Administration and Immune Measures during Adjuvant Chemotherapy in Colon Cancer Patients: Preliminary Results.,"Adjuvant chemotherapy is recommended in high-risk stage II-III colorectal cancer (CC). We examine the effect of daily wheatgrass juice (WGJ) intake in addition to chemotherapy on immune parameters, including IL-6, IL-8, IL-10, IL-12, and white blood cells (WBCs) among CC patients. In a controlled prospective trial, 100 stage II-III CC patients were enrolled. According to patient preference, they were divided into two subgroups, control group and intervention group, 50 patients each, all of whom received the same standard postoperative adjuvant chemotherapy, plus consumption of 60 cc WGJ daily in the intervention group. Blood samples were collected at baseline (T0) and upon treatment termination, 5-6 months later (T1). Cytokine concentrations were assessed using ELISA kits. Anti-inflammatory cytokine IL-10 concentrations were significantly higher in the WGJ group than in the control group at T1. The decline in WBC counts between T0 and T1 was significantly lower in the WGJ group. No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups. The higher levels of IL-10 and the attenuating of WBC decline during chemotherapy may constitute preliminary evidence of the beneficial effects of WGJ on immune parameters, when given as a supplement to standard care. In light of these preliminary results, WGJ supports immunological parameters during adjuvant chemotherapy. Nevertheless, future studies are needed in order to translate those results to clinical recommendations for cancer survivors.",2020,"No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups.","['100 stage II-III CC patients were enrolled', 'Colon Cancer Patients', 'high-risk stage II-III colorectal cancer (CC']","['Adjuvant chemotherapy', 'daily wheatgrass juice (WGJ', 'standard postoperative adjuvant chemotherapy, plus consumption of 60 cc WGJ daily in the intervention group', 'WGJ']","['IL-6, IL-8, and IL-12 concentrations', 'Blood samples', 'WBC counts', 'Cytokine concentrations', 'immune parameters, including IL-6, IL-8, IL-10, IL-12, and white blood cells (WBCs', 'Anti-inflammatory cytokine IL-10 concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1080691', 'cui_str': 'Genus Agropyron'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",100.0,0.0450561,"No significant differences were observed in IL-6, IL-8, and IL-12 concentrations between the study groups.","[{'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Avisar', 'Affiliation': 'The Graduate Studies Authority, University of Haifa, Haifa 31000, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'School of Social Work, University of Haifa, Haifa 31000, Israel.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Clinical Immunology and Tissue Typing Lab, Rambam Medical Center, Haifa 31000, Israel.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Shentzer Kutiel', 'Affiliation': 'Division of Oncology, Rambam Health Care Campus, Haifa 31000, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Aharon', 'Affiliation': 'Hematology and Bone Marrow Transplantation, Sourasky Medical Center, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bar-Sela', 'Affiliation': 'Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa 31000, Israel.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13060129']
1692,32586736,Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events.,"BACKGROUND


Increased rates of respiratory adverse events have been observed in people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with lumacaftor/ivacaftor, particularly in those with percent predicted forced expiratory volume in 1 s (ppFEV 1 ) of <40%. We evaluated the safety, tolerability, and efficacy of tezacaftor/ivacaftor in people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.
METHODS


Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90% were randomized 1:1 and treated with tezacaftor/ivacaftor or placebo for 56 days.
RESULTS


Of 97 participants, 94 (96.9%) completed the study. The primary endpoint was incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor, 14.0%; placebo, 21.3%. The adverse events were mild or moderate in severity. None were serious or led to treatment interruption or discontinuation. Overall, the discontinuation rate was similar between groups. The mean (SD) ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo. The posterior mean difference in absolute change in ppFEV 1  from baseline to the average value of days 28 and 56 was 2.7 percentage points with tezacaftor/ivacaftor vs placebo.
CONCLUSIONS


Tezacaftor/ivacaftor was generally safe, well tolerated, and efficacious in people ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90% who previously discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.",2020,ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"['Of 97 participants, 94 (96.9%) completed the study', 'people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events', 'people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with', 'people ≥12 years of age with cystic fibrosis homozygous', 'people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms', 'Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90']","['tezacaftor/ivacaftor or placebo', 'tezacaftor/ivacaftor', 'Tezacaftor/ivacaftor', 'lumacaftor/ivacaftor', 'placebo']","['safe, well tolerated, and efficacious', 'discontinuation rate', 'mean (SD', 'adverse events', 'incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor', 'safety, tolerability, and efficacy']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0085129', 'cui_str': 'Bronchial hyperreactivity'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",97.0,0.134808,ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Christiane Herzog Zentrum Berlin/Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: carsten.schwarz@charite.de.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Division of Cystic Fibrosis, Department of Pulmonary Medicine, Faculty of Medicine, Universitat Duisburg Essen-Ruhrlandklinik, Essen, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Epaud', 'Affiliation': 'Cystic Fibrosis and Rare Lung Disease Centre, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Ross C', 'Initials': 'RC', 'LastName': 'Klingsberg', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Pneumologische Praxis München-Pasing, Munich, Germany.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Audhya', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ferro', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Duncan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Bote G', 'Initials': 'BG', 'LastName': 'Bruinsma', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.06.001']
1693,32588194,"Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction.","AIM


Blood flow restriction (BFR) exercise is a common alternative to traditional high-load resistance exercise used to increase muscle size and strength. Some populations utilizing BFR at a low load may wish to limit their cardiovascular response to exercise. Different contraction patterns may attenuate the cardiovascular response, but this has not been compared using BFR.
PURPOSE


To compare the cardiovascular response to unilateral (UNI), bilateral (BIL), and alternating (ALT) BFR exercise contraction patterns.
METHODS


Twenty healthy participants performed four sets (30 s rest) of knee extensions to failure, using 30% one-repetition maximum, 40% arterial occlusion pressure, and each of the three contraction patterns (on different days, at the same time of day, separated by 2-10 days, randomized). Cardiovascular responses, presented as pre- to post-exercise mean changes (SD), were measured using pulse wave analysis and analyzed with Bayesian RMANOVA.
RESULTS


ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures. Aortic [ΔmmHg bpm: ALT = 4945(2340); UNI = 3294(1408); BIL = 3428 (1461); BF 10  = 113.659] and brachial [ΔmmHg bpm: ALT = 6134(2761); UNI = 4300(1709); BIL = 4487(1701); BF 10  = 31.845] rate pressure products, as well as heart rate [Δbpm: ALT = 26(14); UNI = 19(8); BIL = 19(11); BF 10  = 5.829] were greatest with ALT. Augmentation index [Δ%: UNI = -6(13); BIL = - 7(11); ALT = - 5(16); BF 10  = 0.155] and wave reflection magnitude [Δ%: UNI = - 5(9); BIL = - 4(7); ALT = - 4(7); BF 10  = 0.150] were not different.
CONCLUSION


Those at risk of a cardiovascular event may choose unilateral or bilateral BFR exercise over alternating until further work determines the degree to which it can be tolerated.",2020,"RESULTS


ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures.","['\u20094945(2340); UNI\u2009=\u20093294(1408); BIL\u2009=\u20093428 (1461); BF 10 \u2009=\u2009113.659] and brachial [ΔmmHg\xa0bpm: ALT\u2009=\u20096134(2761); UNI\u2009=\u20094300(1709); BIL\u2009=\u20094487(1701); BF 10 \u2009=\u200931.845] rate pressure products, as well as heart rate [Δbpm: ALT\u2009=\u200926(14); UNI\u2009=\u200919(8); BIL\u2009=\u200919(11); BF 10 \u2009=\u20095.829', 'Twenty healthy participants']","['Blood flow restriction (BFR) exercise', 'unilateral, bilateral, and alternating resistance exercise with blood flow restriction', 'ALT']","[' aortic systolic', 'BFR exercise contraction patterns', 'cardiovascular response to unilateral (UNI), bilateral (BIL), and alternating (ALT', 'cardiovascular response', 'Cardiovascular responses']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]",20.0,0.0326334,"RESULTS


ALT caused greater changes in: aortic systolic [ΔmmHg: ALT = 21(8); UNI = 13(11); BIL = 15(8); BF 10  = 29.599], diastolic [ΔmmHg: ALT = 13(8); UNI = 7(11); BIL = 8(8); BF 10  = 5.175], and mean arterial [ΔmmHg: ALT = 19(8); UNI = 11(11); BIL = 13(7); BF 10  = 48.637] blood pressures.","[{'ForeName': 'Daphney M', 'Initials': 'DM', 'LastName': 'Stanford', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, Recreation and Sports Management, The University of Mississippi, 215 Turner Center, University, MS, 38677, USA.'}, {'ForeName': 'Joonsun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McCoy', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Jessee', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, Recreation and Sports Management, The University of Mississippi, 215 Turner Center, University, MS, 38677, USA. mbjessee@olemiss.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04401-w']
1694,32590137,Bone turnover markers in children living with HIV remaining on ritonavir-boosted lopinavir or switching to efavirenz.,"INTRODUCTION


We previously found lower bone mass but similar bone turnover in pre-pubertal children living with HIV (CLWH) on a ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy regimen 2 years after switch. Here, we evaluate if bone turnover differed between the groups close to the time of switch.
METHODS


Samples from 108 children remaining on LPV/r and 104 children switched to efavirenz were available for analysis 8 weeks post-randomization. Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin were measured. Markers of immune activation were also measured, including IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP).
RESULTS


Eight weeks post-randomization, we did not detect differences in CTx (1.42 vs. 1.44 ng/mL, p = 0.85) or P1NP concentrations (622 vs. 513 ng/mL, p = 0.68) between treatment groups. At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP. Osteocalcin (ng/mL) was higher in the LPV/r than efavirenz group both at 8 weeks (88.6 vs. 67.3, p = 0.001) and 2 years (67.6 vs. 49.8, p = 0.001).
CONCLUSIONS


Overall, we failed to detect difference in bone turnover by P1NP and CTx in virologically-suppressed CLWH on different regimens at a time point close to the switch. We did observe higher levels of total osteocalcin in children remaining on LPV/r compared to children switched to efavirenz. Future studies should focus on uncovering the mechanism and determining whether perturbation in undercarboxylated osteocalcin could explain some of the bone side effects noted with protease inhibitors.",2020,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","['children living with HIV remaining on ritonavir-boosted lopinavir or switching to', 'Samples from 108 children remaining on LPV/r and 104 children switched to', 'pre-pubertal children living with HIV (CLWH) on a']","['efavirenz', 'ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy']","['IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP', 'Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin', 'levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP', 'Osteocalcin', 'bone turnover by P1NP and CTx', 'total osteocalcin', 'CTx', 'Bone turnover markers', 'bone turnover', 'P1NP concentrations', 'Markers of immune activation']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.0664262,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA. Electronic address: sma2@columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115500']
1695,32590214,Perceived social support and posttraumatic stress symptoms in children and youth in therapy: A parallel process latent growth curve model.,"Many studies show that perceived social support protects against the development of posttraumatic stress symptoms (PTSS) in the aftermath of trauma, but less is known about support in relation to PTSS in trauma therapy. This study examined associations between perceived social support and PTSS in children and adolescents during trauma therapy. Parallel process latent growth curve modeling was used to examine trajectories of perceived social support and PTSS over five measurement waves in a sample of 156 patients, aged between 10 and 18 years (M age = 15.1, SD = 2.2, 79.5% girls), randomized to receive trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU). Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy. Most of the change occurred during therapy and was maintained after therapy. Higher levels of PTSS prior to therapy were associated with lower levels of perceived social support prior to therapy, and a decrease in PTSS was associated with increase in perceived social support. This co-development may have been directed by a third underlying factor or short-term temporal effects. Studies investigating within-person associations over shorter time intervals will benefit our understanding of possible temporal effects.",2020,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"['children and adolescents during trauma therapy', '156 patients, aged between 10 and 18 years (M age\xa0=\xa015.1, SD\xa0=\xa02.2, 79.5% girls', 'children and youth in therapy']",['trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU'],"['Perceived social support and posttraumatic stress symptoms', 'PTSS', 'perceived social support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1320387', 'cui_str': 'Trauma therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",156.0,0.02545,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Birkeland', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway. Electronic address: Marianne.s.birkeland@gmail.com.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Division of Mental & Physical Health, Norwegian Institute of Public Health, Norway.'}, {'ForeName': 'Silje M', 'Initials': 'SM', 'LastName': 'Ormhaug', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway.'}, {'ForeName': 'Tine K', 'Initials': 'TK', 'LastName': 'Jensen', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway; Department of Psychology, University of Oslo, Norway.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103655']
1696,32591295,Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.,"INTRODUCTION AND OBJECTIVES


Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.
METHODS


ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.
RESULTS


The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.
CONCLUSIONS


ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.",2020,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","['320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to', 'HF patients with reduced left ventricular ejection fraction']","['angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB', 'HF nurse titration vs 156 to HF cardiologist titration']","['mortality and heart failure (HF) hospitalizations', 'safety and efficacy', 'adverse events', 'ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months', 'mean±standard deviation visits', 'beta-blocker mean relative dose']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",320.0,0.116585,"Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations.","[{'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Oyanguren', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain. Electronic address: juanaoy@hotmail.com.'}, {'ForeName': 'Lluisa', 'Initials': 'L', 'LastName': 'Garcia-Garrido', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Nebot-Margalef', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Latorre-García', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torcal-Laguna', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Roure', 'Affiliation': ""Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Costello', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Manito', 'Affiliation': ""Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Sánchez-Paule', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Varela-Román', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moure', 'Affiliation': 'Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Segovia-Cubero', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Soria', 'Affiliation': 'Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Lekuona', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.04.016']
1697,32596764,Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.,"PURPOSE


This study aimed to evaluate the quality and quantity of newly generated bone in the maxillary sinus grafted with stem cell-based allograft material.
METHODS


This study was a single site, prospective, blinded, randomized, and controlled clinical trial. Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled. At the time of sinus augmentation, test sinus was grafted with stem cell-based allograft (Osteocel Plus; NuVasive Therapeutics), while the control sinus was grafted with conventional cortico-cancellous allograft (alloOss; ACE Surgical). Cone beam computer tomography (CBCT) scan was taken before and 14 weeks post-sinus augmentation procedure, i.e., 2 weeks before implant placement. Thirty-six trephined core bone biopsies were harvested from the anterior and posterior grafted lateral-window osteotomy sites at the time of implant placement.
RESULTS


The results showed a statistically significant difference in the vital bone percentage between the test and the control groups at the posterior grafted sites (p = 0.03). There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05). The CBCT analysis showed that the maxillary sinuses at the posterior grafted sites were statistically wider than those at the anterior grafted sites in both groups (p < .05).
CONCLUSIONS


Different allograft bone materials can be used in the maxillary sinus augmentation procedures. Stem cell allograft has more osteogenic potential with a better outcome in the wide posterior sinus.",2020,There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05).,"['maxillary sinus bone regeneration', 'Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled']","['Cone beam computer tomography (CBCT) scan', 'stem cell allograft', 'stem cell-based allograft material']","['vital bone percentage', 'percentage of vital bone', 'quality and quantity']","[{'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",11.0,0.0295757,There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05).,"[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Whitt', 'Affiliation': 'University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Al-Sabbagh', 'Affiliation': 'Division of Periodontology, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Dolphus', 'Initials': 'D', 'LastName': 'Dawson', 'Affiliation': 'University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Shehata', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Moly', 'Initials': 'M', 'LastName': 'Housley-Smith', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tezanos', 'Affiliation': 'Department of Statistics, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kutkut', 'Affiliation': 'Division of Prosthodontics, University of Kentucky College of Dentistry, 800 Rose St. D646, Lexington, KY, 40536, USA. ahmad.kutkut@uky.edu.'}]",International journal of implant dentistry,['10.1186/s40729-020-00222-w']
1698,32599496,Randomized controlled three-arm study of NADA acupuncture for alcohol addiction.,"INTRODUCTION


Alcohol addiction compromises cardiovascular health, possibly due to impaired control of the heart and vasculature by the autonomic nervous system. We aimed to assess the effects of National Acupuncture Detoxification Association (NADA) acupuncture on cardiovascular autonomic functions, psychiatric comorbidities and abstinence in patients addicted to alcohol.
MATERIAL AND METHODS


A randomized sham controlled three-arm study was undertaken in 72 patients (nine females, aged 43.7 ± 9.2 years, mean ± SD) undergoing in-patient rehabilitation for alcohol addiction. Patients were randomly allocated (1:1:1) to receive twenty 30-minute NADA or sham acupuncture sessions within six weeks or no intervention. They were evaluated for craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response). Testing was performed at baseline, immediately post intervention (sham intervention or control period, respectively) and another four weeks later. Abstinence was assessed one year after study completion.
RESULTS


Patients in the NADA arm displayed increased HRV immediately post-intervention compared to baseline (SDNN: 72.8 ms ± 34.2 ms vs. 57.9 ms ± 31.2 ms, p = 0.001). This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015). HRV remained unaltered following sham or no acupuncture (p = n.s.). Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence did not differ between study arms.
CONCLUSIONS


NADA acupuncture may improve autonomic cardiac function. However, this improvement appears not to translate into alleviation of psychiatric comorbidities or sustained abstinence.",2020,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","['patients addicted to alcohol', '72 patients (nine females, aged 43.7\xa0±\xa09.2\xa0years, mean\xa0±\xa0SD) undergoing in-patient rehabilitation for alcohol addiction', '34.2']","['NADA or sham acupuncture sessions within six weeks or no intervention', 'National Acupuncture Detoxification Association (NADA) acupuncture', 'sham or no acupuncture', 'NADA acupuncture']","['HRV', 'Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence', 'craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response', 'autonomic cardiac function', 'cardiovascular autonomic functions, psychiatric comorbidities and abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C5191359', 'cui_str': '34.2'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0038989', 'cui_str': 'Sweat gland structure'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",72.0,0.09429,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Penzlin', 'Affiliation': 'Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ritschel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Barlinn', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Reichmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Siepmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. Electronic address: timo.siepmann@ukdd.de.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106488']
1699,32599497,A randomized comparison of estimated radiation exposure between Low and conventional dose protocol during invasive coronary angiography (ERICA trial): Pilot study.,"PURPOSE


Radiation exposure during coronary angiography is potentially harmful to patients and operators. However, there are limited data on the effects of a low-dose radiation angiography. We evaluated the feasibility and effectiveness of a reduced radiation dose protocol during invasive coronary angiography.
METHODS


One hundred three consecutive patients who underwent coronary angiography were enrolled and randomized to low- or conventional dose protocols (LDP versus CDP). The LDP consists of 10 frames per second during fluoroscopy and half the radiation dose of CDP during cineangiography. Image quality was assessed using a Likert rating scale by an independent radiologist. The radiation dose was estimated with dose-area product (DAP) and air-kerma (AK).
RESULTS


Body weight and waist circumference are well correlated with the level of DAP and AK. Exposure time and total images and frame counts in cineangiography were similar in both groups. There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP: LDP 1980.1 ± 1163.7 vs. CDP 3434.2 ± 2188.1 μGym 2  p = 0.001; total AK: 279.6 ± 159.3 vs. 493.8 ± 280.6 mGy, p < 0.001).
CONCLUSION


The LDP reduced the total estimated radiation dose compared to the CDP without a significant loss of diagnostic information. A LDP may be a viable strategy to protect patients and medical staff from the hazards of radiation in the cardiac catheterization laboratory.",2020,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,['One hundred three consecutive patients who underwent'],"['estimated radiation exposure between Low and conventional dose protocol', 'low- or conventional dose protocols (LDP versus CDP', 'coronary angiography', 'CDP']","['Body weight and waist circumference', 'feasibility and effectiveness', 'Image quality', 'estimated radiation dose (DAP and AK', 'image quality (total DAP', 'Exposure time and total images and frame counts in cineangiography', 'Likert rating scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0008795', 'cui_str': 'Cineangiography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",103.0,0.0489571,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,"[{'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea. Electronic address: samipark@hanmail.net.'}, {'ForeName': 'Heung Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Christopher Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Utah Cardiology, Farmington, Utah, USA.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109120']
1700,32605492,Nurse-led Care Program with Patients with Heart Failure Using Johnson's Behavioral System Model: A Randomized Controlled Trial.,"Patients with heart failure experience system imbalance and have multiple symptoms. A nurse-led care program based on Johnson's behavioral system model was used to improve the balance of the behavioral system of heart failure patients. One hundred and fifty patients were randomly assigned into two groups. In the experimental group, the patient's status was evaluated by a behavioral subsystem assessment tool related to the level of imbalance. The patients in the intervention group received care individually based on their worst subsystem scores over a period of 2 weeks. The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p  < .05) subsystems in the experimental group. However, no significant difference was seen in sexual and affiliative ( p  > .05) subsystems.",2020,"The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p  < .05) subsystems in the experimental group.","['heart failure patients', 'Patients with Heart Failure', 'One hundred and fifty patients', 'Patients with heart failure experience system imbalance and have multiple symptoms']","['Nurse-led Care Program', ""Johnson's Behavioral System Model""]","['restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement', 'sexual and affiliative']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231217', 'cui_str': 'Multiple symptoms'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",150.0,0.0158106,"The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p  < .05) subsystems in the experimental group.","[{'ForeName': 'Behnoush', 'Initials': 'B', 'LastName': 'Rahmani', 'Affiliation': 'MSc Student, Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': 'Assistant professor, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Professor, Department of Biostatistics and Epidemiology, Social Determinants of Health.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Florczak', 'Affiliation': 'Assistant Professor, Purdue University Northwest, Calumet, IN, USA.'}]",Nursing science quarterly,['10.1177/0894318420932102']
1701,32605881,Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.,"BACKGROUND AND AIMS


Metabolic syndrome (MetS) increases the risk of cardiovascular disease and type 2 diabetes. Despite a higher prevalence of MetS in African American (AA) women, little is known about the effectiveness of lifestyle interventions in improving metabolic markers in this high-risk group. This study investigated the effectiveness of a community-based lifestyle intervention delivered by lay health coaches in reducing MetS among AA women.
METHODS AND RESULTS


A cluster-randomized diabetes prevention program (DPP) was implemented in 11 churches utilizing a community-based participatory research (CBPR) approach to develop and deliver the interventions. A total of 221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study. The prevalence of MetS was 42.08% before receiving the DPP intervention and 31.22% after the intervention that represented a 10.86% absolute reduction and a 25.81% relative reduction from baseline. The adjusted odds ratio (OR) of being free from MetS at post-intervention in contrast to baseline was 2.14 (p = 0.02). Factors that increased the odds of being free from MetS were younger age, reduction in intake of total calories, total fat, saturated and trans-fat, and dietary sodium.
CONCLUSION


A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese. Findings from this study can be used to translate evidence into public health programs at the community level for the prevention of type 2 diabetes and cardiovascular disease.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04082702 (www.clinicaltrials.gov).",2020,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"['African American (AA) women', 'AA women', 'African American women', '11 churches utilizing a community-based participatory research (CBPR', '221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study', 'AA women who were overweight or obese']","['diabetes prevention program (DPP', 'community-based lifestyle intervention']","['adjusted odds ratio (OR) of being free from MetS', 'prevalence of MetS']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",221.0,0.0456853,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA. Electronic address: abdullah.mamun@bswhealth.org.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA; Baylor University, Waco, TX, USA.'}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Dodgen', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.005']
1702,32579810,Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes.,"BACKGROUND


Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease.
METHODS


In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m 2  of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed.
RESULTS


A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m 2  in the allopurinol group and 67.3 ml per minute per 1.73 m 2  in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m 2  (95% confidence interval [CI], -1.9 to 1.9; P = 0.99). The mean decrease in the iohexol-based GFR was -3.0 ml per minute per 1.73 m 2  per year with allopurinol and -2.5 ml per minute per 1.73 m 2  per year with placebo (between-group difference, -0.6 ml per minute per 1.73 m 2  per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups.
CONCLUSIONS


We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).",2020,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","['persons with type 1 diabetes and early-to-moderate diabetic kidney disease', 'Type 1 Diabetes', 'patients with type 1 diabetes and early-to-moderate diabetic kidney disease', '267 patients']","['placebo', 'allopurinol or placebo', 'allopurinol', 'Allopurinol']","['Safety', 'frequency of serious adverse events', 'baseline-adjusted GFR', 'iohexol-based GFR per year and the urinary albumin excretion rate', 'mean baseline iohexol-based GFR', 'mean serum urate level', 'iohexol-based GFR', 'kidney outcomes', 'mean urinary albumin excretion rate', 'mean iohexol-based GFR', 'glomerular filtration rate (GFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.615998,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Andrzej T', 'Initials': 'AT', 'LastName': 'Galecki', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Cherney', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Parsa', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afkarian', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'M Luiza', 'Initials': 'ML', 'LastName': 'Caramori', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Elliott', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'J Sonya', 'Initials': 'JS', 'LastName': 'Haw', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Karger', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Pragnell', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Robiner', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sylvia E', 'Initials': 'SE', 'LastName': 'Rosas', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Senior', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916624']
1703,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND


Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD.
METHODS


In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy.
RESULTS


The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
CONCLUSIONS


The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082']
1704,32583431,"Randomised phase II study to optimise melphalan, prednisolone, and bortezomib in untreated multiple myeloma (JCOG1105).","We conducted a randomised phase II study to determine the optimal dose and schedule of melphalan, prednisone, and bortezomib (MPB) (jRCTs031180097). Transplant-ineligible untreated multiple myeloma patients were randomised to Arm A (twice weekly bortezomib in one six-week cycle followed by eight five-week cycles of four times once weekly bortezomib with melphalan and prednisolone on days 1-4) or Arm B (nine four-week cycles of three times once weekly bortezomib with melphalan and prednisolone on days 1-4). The primary end-point was complete response (CR) rate. Of 91 patients randomised to two arms, 88 were eligible. The median cumulative bortezomib doses were 45·8 and 35·1 mg/m 2  , CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR) 1·93 (95% CI 1·09-3·42)], respectively. Frequent grade ≥3 haematologic toxicities in Arms A and B were neutropenia (64·4% vs. 28·3%) and thrombocytopenia (35·6% vs. 10·9%). Grade 2/3 peripheral neuropathy was observed in 24·4/2·2% in Arm A and 8·7/0% in Arm B. In conclusion, Arm A was the more promising regimen, suggesting that the twice weekly schedule of bortezomib in the first cycle and higher cumulative dose of both bortezomib and melphalan influences the efficacy of modified MPB.",2020,", CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR)","['1·93', 'Transplant-ineligible untreated multiple myeloma patients', '91 patients randomised to two arms, 88 were eligible']","['bortezomib and melphalan', 'melphalan, prednisone, and bortezomib (MPB', 'bortezomib with melphalan and prednisolone', 'optimise melphalan, prednisolone, and bortezomib', 'bortezomib']","['neutropenia', 'complete response (CR) rate', 'CR rate', 'Frequent grade ≥3 haematologic toxicities', 'thrombocytopenia', 'Grade 2/3 peripheral neuropathy', 'median progression-free survival (PFS', 'median cumulative bortezomib doses']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0926135,", CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR)","[{'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operating Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Hematology and Oncology, Mie University School of Medicine, Tsu, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yoshimitsu', 'Affiliation': 'Department of Hematology and Rheumatology, Kagoshima University Hospital, Kagoshima, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Division of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Norifumi', 'Initials': 'N', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Hematology, Gunma University, Maebashi, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tsujimura', 'Affiliation': 'Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hangaishi', 'Affiliation': 'Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Utsumi', 'Affiliation': 'Department of Hematology, Shiga General Hospital, Moriyama, Japan.'}, {'ForeName': 'Ishikazu', 'Initials': 'I', 'LastName': 'Mizuno', 'Affiliation': 'Division of Hematology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Nagata', 'Affiliation': 'Department of Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Minauchi', 'Affiliation': 'Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ohtsuka', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Hanamura', 'Affiliation': 'Division of Hematology, Aichi Medical University, Nagakute, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Youko', 'Initials': 'Y', 'LastName': 'Suehiro', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Clinical Oncology and Hematology, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",British journal of haematology,['10.1111/bjh.16878']
1705,32585581,"Zataria multiflora affects clinical symptoms, oxidative stress and cytokines in asthmatic patient: A randomized, double blind, placebo-controlled, phase II clinical trial.","BACKGROUND


Z. multiflora effect on clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels in asthmatic patients were evaluated.
METHODS


36 asthmatic patients were divided to; placebo group (P), two groups treated with Z. multiflora extract (5 and 10 mg/kg/day, as Z5 and Z10, respectively), (n = 12 in each group). Medications were administered three times a day for two months and several parameters were evaluated before treatment (step 0), one (step 1) and two months (step 2) after treatment.
RESULTS


Clinical symptoms and PFTs were significantly improved in Z5 and Z10 groups in steps 1 and 2 compared to step 0 (p < 0.05 to p < 0.001). Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001).
CONCLUSION


These results indicated therapeutic value of Z. multiflora for the management of asthma.",2020,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001).
","['36 asthmatic patients', 'asthmatic patient', 'asthmatic patients were evaluated']","['Zataria multiflora', 'Z. multiflora extract', 'placebo']","['oxidative stress, cytokines levels and their gene expression', 'Clinical symptoms and PFTs', 'clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",36.0,0.141139,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001).
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rajabi', 'Affiliation': 'Department of Drug and Food Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155169']
1706,32586026,The Office Work and Stretch Training (OST) Study: An Individualized and Standardized Approach to Improve the Quality of Life in Office Workers.,"In the context of workplace health promotion, physical activity programs have been shown to reduce musculoskeletal diseases and stress, and to improve the quality of life. The aim of this study was to examine the effects of using the ""five-Business"" stretch training device for office workers on their quality of life. A total of 313 office workers (173m/137f) participated voluntarily in this intervention-control study with an average age of 43.37 ± 11.24 (SD) years, 175.37 ± 9.35 cm in height and 75.76 ± 15.23 kg in weight, with an average BMI of 24.5 ± 3.81 kg/m 2 . The participants completed the stretch training twice a week for approximately 10 minutes for a duration of 12 weeks. The SF-36 questionnaire was used to evaluate the effectiveness of the intervention at baseline and after 12 weeks. Significantly improved outcomes in mental sum score ( p  = 0.008), physical functioning ( p  < 0.001), bodily pain ( p  = 0.01), vitality ( p  = 0.025), role limitations due to physical problems ( p  = 0.018) and mental health ( p  = 0.012) were shown after the stretching training. The results suggest that a 12-week stretching program for office desk workers is suitable to improve significantly their health-related quality of life.",2020,"Significantly improved outcomes in mental sum score ( p  = 0.008), physical functioning ( p  < 0.001), bodily pain ( p  = 0.01), vitality ( p  = 0.025), role limitations due to physical problems ( p  = 0.018) and mental health ( p  = 0.012) were shown after the stretching training.","['Office Workers', 'A total of 313 office workers (173m/137f) participated voluntarily in this intervention-control study with an average age of 43.37 ± 11.24 (SD) years, 175.37 ± 9.35 cm in height and 75.76 ± 15.23 kg in weight, with an average BMI of 24.5 ± 3.81 kg/m 2 ']","['stretch training', 'Stretch Training', 'five-Business"" stretch training device']","['quality of life', 'Quality of Life', 'health-related quality of life', 'vitality', 'physical functioning', 'mental health', 'bodily pain', 'mental sum score']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",313.0,0.0320827,"Significantly improved outcomes in mental sum score ( p  = 0.008), physical functioning ( p  < 0.001), bodily pain ( p  = 0.01), vitality ( p  = 0.025), role limitations due to physical problems ( p  = 0.018) and mental health ( p  = 0.012) were shown after the stretching training.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Holzgreve', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Maltry', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Hänel', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Daimler AG, 70171 Stuttgart, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bader', 'Affiliation': 'Daimler AG, 70171 Stuttgart, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Frei', 'Affiliation': 'Mercedes-Benz AG, 76437 Rastatt, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modeling, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'David Alexander', 'Initials': 'DA', 'LastName': 'Groneberg', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ohlendorf', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'van Mark', 'Affiliation': 'Institute for Occupational Medicine, Goethe-University Frankfurt, 60590 Frankfurt am Main, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124522']
1707,32586063,Physical Activity Levels of Chilean Children in a National School Intervention Programme. A Quasi-Experimental Study.,"Background . Recess is a great opportunity to interrupt sedentary behaviour and increase moderate-to-vigorous physical activity (MVPA) in schoolchildren. This quasi-experimental study aimed to compare the levels of physical activity (PA) during the school day of children in a school intervention programme vs. those in a control group, and to determine compliance with MVPA recommendations.  Methods.  A sample of 154 schoolchildren (6-12 years old) was obtained from several schools (70 with the intervention and 84 controls). This programme was structured with a duration of 90 min/session and performed three times/week. PA levels were recorded with triaxial accelerometers during the school day: during recess, during a PA session or physical education session (PE), and during lunchtime. No pre-intervention evaluation was performed.  Results.  The MVPA of the control group was higher than that of the intervention group during the first recess ( p  < 0.001). None of the groups complied with the recommendations for steps during the PA or PE sessions. During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group. Fifty percent of the children from the intervention group complied with the MVPA recommendations, vs. 22.7% of those in the control group.  Conclusions.  The schoolchildren in the intervention group performed more MVPA than those in the control group. Future interventions could include other periods, such as recess and lunchtime, which are opportunities for improving the MVPA levels of schoolchildren.",2020,"During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group.","['schoolchildren', '154 schoolchildren (6-12 years old) was obtained from several schools (70 with the intervention and 84 controls', 'Chilean Children in a National School Intervention Programme']",['MVPA'],"['levels of physical activity (PA', 'Physical Activity Levels', 'PA levels']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015737', 'cui_str': 'National Government'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",154.0,0.0162662,"During the PA session, sedentary time was lower and MVPA was higher, in the intervention group than in the control group.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso 2340025, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cristi-Montero', 'Affiliation': 'IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso 2340025, Chile.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cadiz, 11003 Cadiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124529']
1708,32586363,Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


In this study, we investigate the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in cancer patients being treated.
TRIAL DESIGN


This is a multi-centre, two-arm, parallel-group, triple-blind, phase 2-3 randomised controlled trial.
PARTICIPANTS


All patients over the age of 15 from 5 types of cancer are included in the study. Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study. The exclusion criteria will include known sensitivity to Hydroxychloroquine, weight below 35 kilograms, history of retinopathy, history of any cardiac disease, acute respiratory tract infection in the last 2 months, having COVID-19 in the first two weeks of entering the trial, having Diabetes Mellitus, having an immuno-suppressive disease other than cancer, having chronic pulmonary disease and taking immuno-suppressant drug other than chemotherapeutic agents for current cancer. This study is performed in five academic centres affiliated to Mashhad University of Medical Sciences, Mashhad, Iran.
INTERVENTION AND COMPARATOR


Patients are randomly assigned to two groups; one being given hydroxychloroquine and the other is given placebo. During two months of treatment, the two groups are treated with either hydroxychloroquine (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo (identical in terms of shape, colour, smell) as a single 200 mg tablet every other day. Patients will be monitored for COVID-19 symptoms during the follow-up period. If signs or symptoms occur (fever, cough, shortness of breath), they will be examined and investigated with a high-resolution computed tomography (CT) scan of the lungs, COVID-19 specific IgM, IgG antibody assay and a nucleic acid amplification test (NAT) for the SARS-CoV-2 virus.
MAIN OUTCOMES


The primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer over a 2-month period.
RANDOMISATION


Randomisation will be performed using randomly permuted blocks. By using an online website (www.randomization.com) the randomization sequence will be produced by quadruple blocks. The allocation ratio in intervention and control groups is 1:1.
BLINDING (MASKING)


Participants and caregivers do not know whether the patient is in the intervention or the control group. The outcome assessor and the data analyst are also blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The calculated total sample size is 60 patients, with 30 patients in each group.
TRIAL STATUS


The trial began on April 14, 2020 and recruitment is ongoing. Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020.
TRIAL REGISTRATION


This trial has been registered by the title of ""Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment"" in Iranian Registry of Clinical Trials (IRCT) with code ""IRCT20200405046958N1"", https://www.irct.ir/trial/46946. Registration date is April 14, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020.
","['cancer patients', 'five academic centres affiliated to Mashhad University of Medical Sciences, Mashhad, Iran', 'All patients over the age of 15 from 5 types of cancer are included in the study', 'cancer patients being treated', ""Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer"", '60 patients, with 30 patients in each group', 'cancer patients undergoing treatment', 'patients being treated for their cancer over a 2-month period']","['placebo', 'Hydroxychloroquine', 'hydroxychloroquine (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo', 'hydroxychloroquine']","['incidence of COVID-19', 'signs or symptoms occur (fever, cough, shortness of breath']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023470', 'cui_str': 'Myeloid leukemia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.193621,"Recruitment is anticipated to be completed by June 14, 2020 There has been no change in study protocol since approval, protocol version 1 was approved April 12, 2020.
","[{'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Khadem-Rezaiyan', 'Affiliation': 'Community Medicine, Clinical Research Development Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mozaheb', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Seddigh-Shamsi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bary', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Kamandi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sajad Ataei', 'Initials': 'SA', 'LastName': 'Azimi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeed Eslami', 'Initials': 'SE', 'LastName': 'HasanAbadi', 'Affiliation': 'Medical Informatics, Pharmacy School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Noferesti', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Somayeh Sadat', 'Initials': 'SS', 'LastName': 'Shariatmaghani', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Rafatpanah', 'Affiliation': 'Immunology, Immunology Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Khatami', 'Affiliation': 'Internal Medicine, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Afshin Jabbar', 'Initials': 'AJ', 'LastName': 'Imani', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mortazi', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Moeini', 'Initials': 'MM', 'LastName': 'Nodeh', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. moeininm@mums.ac.ir.'}]",Trials,['10.1186/s13063-020-04485-x']
1709,32588435,Ketogenic diets for drug-resistant epilepsy.,"BACKGROUND


Ketogenic diets (KDs) are high in fat and low in carbohydrates and have been suggested to reduce seizure frequency in people with epilepsy. Such diets may be beneficial for children with drug-resistant epilepsy. This is an update of a review first published in 2003, and last updated in 2018.
OBJECTIVES


To assess the effects of ketogenic diets for people with drug-resistant epilepsy.
SEARCH METHODS


For this update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 26 April 2019) on 29 April 2019. The Cochrane Register of Studies includes the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and randomised controlled trials (RCTs) from Embase, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We checked the reference lists of retrieved studies for additional relevant studies.
SELECTION CRITERIA


RCTs or quasi-RCTs of KDs for people of any age with drug-resistant epilepsy.
DATA COLLECTION AND ANALYSIS


Two review authors independently applied predefined criteria to extract data and evaluated study quality. We assessed the outcomes: seizure freedom, seizure reduction (50% or greater reduction in seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate. We incorporated a meta-analysis. We utilised an intention-to-treat (ITT) population for all primary analyses. We presented the results as risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS


We identified 13 studies with 932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over). We assessed all 13 studies to be at high risk of performance and detection bias, due to lack of blinding. Assessments varied from low to high risk of bias for all other domains. We rated the evidence for all outcomes as low to very low certainty. Ketogenic diets versus usual care for children Seizure freedom (RR 3.16, 95% CI 1.20 to 8.35; P = 0.02; 4 studies, 385 participants; very low-certainty evidence) and seizure reduction (RR 5.80, 95% CI 3.48 to 9.65; P < 0.001; 4 studies, 385 participants; low-certainty evidence) favoured KDs (including: classic KD, medium-chain triglyceride (MCT) KD combined, MCT KD only, simplified modified Atkins diet (MAD) compared to usual care for children. We are not confident that these estimated effects are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea for both the intervention and usual care group, but the true effect could be substantially different (low-certainty evidence). Ketogenic diet versus usual care for adults In adults, no participants experienced seizure freedom. Seizure reduction favoured KDs (MAD only) over usual care but, again, we are not confident that the effect estimated is accurate (RR 5.03, 95% CI 0.26 to 97.68; P = 0.29; 2 studies, 141 participants; very low-certainty evidence). Adults receiving MAD most commonly reported vomiting, constipation and diarrhoea (very low-certainty evidence). One study reported a reduction in body mass index (BMI) plus increased cholesterol in the MAD group. The other reported weight loss. The true effect could be substantially different to that reported. Ketogenic diet versus ketogenic diet for children Up to 55% of children achieved seizure freedom with a classical 4:1 KD after three months whilst up to 85% of children achieved seizure reduction (very low-certainty evidence). One trial reported a greater incidence of seizure reduction with gradual-onset KD, as opposed to fasting-onset KD. Up to 25% of children were seizure free with MAD and up to 60% achieved seizure reduction. Up to 25% of children became seizure free with MAD and up to 60% experienced seizure reduction. One study used a simplified MAD (sMAD) and reported that 15% of children gained seizure freedom rates and 56% achieved seizure reduction. We judged all the evidence described as very low certainty, thus we are very unsure whether the results are accurate. The most commonly reported adverse effects were vomiting, constipation and diarrhoea (5 studies, very low-certainty evidence). Two studies reported weight loss. One stated that weight loss and gastrointestinal disturbances were more frequent, with 4:1 versus 3:1 KD, whilst one reported no difference in weight loss with 20 mg/d versus 10 mg/d carbohydrates. In one study, there was a higher incidence of hypercalcuria amongst children receiving classic KD compared to MAD. All effects described are unlikely to be accurate. Ketogenic diet versus ketogenic diet for adults One study randomised 80 adults (aged 18 years and over) to either MAD plus KetoCal during the first month with MAD alone for the second month, or MAD alone for the first month followed by MAD plus KetoCal for the second month. No adults achieved seizure freedom. More adults achieved seizure reduction at one month with MAD alone (42.5%) compared to MAD plus KetoCal (32.5%), however, by three months only 10% of adults in both groups maintained seizure reduction. The evidence for both outcomes was of very low certainty; we are very uncertain whether the effects are accurate. Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence). Diarrhoea and increase/change in seizure pattern/semiology were also commonly reported (17.5% to 20% of participants). The true effects of the diets could be substantially different to that reported.
AUTHORS' CONCLUSIONS


The evidence suggests that KDs could demonstrate effectiveness in children with drug-resistant epilepsy, however, the evidence for the use of KDs in adults remains uncertain. We identified a limited number of studies which all had small sample sizes. Due to the associated risk of bias and imprecision caused by small study populations, the evidence for the use of KDs was of low to very low certainty. More palatable but related diets, such as the MAD, may have a similar effect on seizure control as the classical KD, but could be associated with fewer adverse effects. This assumption requires more investigation. For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option. Further research is required, particularly for adults with drug-resistant epilepsy.",2020,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","['932 participants; 711 children (4 months to 18 years) and 221 adults (16 years and over', 'children with drug-resistant epilepsy', 'people of any age with drug-resistant epilepsy', '1946 to 26 April 2019) on 29 April 2019', 'people with epilepsy', 'adults with drug-resistant epilepsy', 'For people who have drug-resistant epilepsy or who are unsuitable for surgical intervention, KDs remain a valid option', 'adults One study randomised 80 adults (aged 18 years and over) to either', 'adults', 'Adults receiving', 'people with drug-resistant epilepsy']","['Ketogenic diets', 'Ketogenic diet versus usual care', 'Ketogenic diet versus ketogenic diet', 'ketogenic diets', 'simplified MAD (sMAD', 'MAD plus KetoCal', 'Ketogenic diets versus usual care', 'MAD']","['seizure frequency), adverse effects, cognition and behaviour, quality of life, and attrition rate', 'seizure freedom rates', 'Diarrhoea', 'body mass index (BMI) plus increased cholesterol', 'seizure free with MAD', 'Constipation', 'outcomes: seizure freedom, seizure reduction', 'vomiting, constipation and diarrhoea', 'weight loss', 'weight loss and gastrointestinal disturbances', 'seizure pattern/semiology', 'seizure reduction', 'seizure freedom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0232459', 'cui_str': 'Abnormal digestive tract function'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",80.0,0.178047,"Constipation was more frequently reported in the MAD plus KetoCal group (17.5%) compared to the MAD only group (5%) (1 study, very low-certainty evidence).","[{'ForeName': 'Kirsty J', 'Initials': 'KJ', 'LastName': 'Martin-McGill', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bresnahan', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Levy', 'Affiliation': 'The Croft Shifta Health Centre, Rochdale, UK.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Cooper', 'Affiliation': 'Centre for Clinical Neurosciences, Salford Royal Hospitals NHS Trust, Salford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001903.pub5']
1710,32589632,"A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambaréné, Gabon.","BACKGROUND


It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study compared these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné, Gabon.
METHODS


Participants presenting with uncomplicated scabies were randomized into either the Individual Treatment group, where only the affected participants received treatment, or the Household Treatment group, where all family members were treated in parallel to the affected participants regardless of signs and symptoms. The primary endpoint was clinical cure after 28 days; the secondary endpoint was the proportion of affected household members per household after 28 days.
RESULTS


After 28 days, from a total of 79 participants assessed, 67% (n = 53) were clinically cured; 59% (20/34) in the Individual Treatment group and 73% (33/45) in the Household Treatment group. Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17). For the secondary outcome, an effect of similar size was observed.
CONCLUSIONS


Our findings show that treating close contacts of persons affected by scabies may be beneficial to patients and contacts, however, the benefit was less pronounced than anticipated and further research is needed to definitively answer this question.",2020,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).",['Participants presenting with uncomplicated scabies'],['topical benzyl benzoate'],['clinical cure'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0053289', 'cui_str': 'benzyl benzoate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",53.0,0.160026,"Participants in the Household Treatment group had about twice the odds of being cured (odds ratio 1.9, 95% confidence interval: 0.8-4.9; p = 0.17).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Matthewman', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Rella Zoleko', 'Initials': 'RZ', 'LastName': 'Manego', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Lia Betty', 'Initials': 'LB', 'LastName': 'Dimessa Mbadinga', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Šinkovec', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Institute of Clinical Biometrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Völker', 'Affiliation': 'Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, & I Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Akinosho', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Haedrich', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': ""Tardif d'Hamonville"", 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ayola Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ramharter', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}, {'ForeName': 'Ghyslain', 'Initials': 'G', 'LastName': 'Mombo-Ngoma', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008423']
1711,32590251,The treatment of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation.,"OBJECTIVES


To compare the advantages and disadvantages of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO) with those of semilunar ganglion RF thermocoagulation (GRF) under local anesthesia, for exploring a new and available surgical method for patients with V2 + V3 idiopathic trigeminal neuralgia.
PATIENTS AND METHODS


102 patients with V2 + V3 idiopathic trigeminal neuralgia were enrolled in this prospective randomized controlled clinical trial, and they were divided into the PRF and GRF group randomly (n = 51 in both groups). The outcome of pain relief was assessed using the Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed). Recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. The immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications were observed and recorded.
RESULTS


Their basic conditions (age, gender ratio, side of pain, and disease duration) were similar. Furthermore, we found that the 2-year postoperative effective rate between them had no significant difference. By comparing the two groups, PRF group had the better immediate effective rate of the V2 branch and no severe complications such as corneal ulcer, however, GRF group had lower 2-year postoperative recurrence rate of the V3 branch and fewer facial swelling.
CONCLUSION


The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.",2020,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","['patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia', '102 patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia']","['PRF and GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation', 'semilunar ganglion RF thermocoagulation (GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO']","['facial swelling', 'pain relief', 'Recurrence', 'immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications', '2-year postoperative effective rate', 'immediate effective rate of the V2 branch and no severe complications such as corneal ulcer', 'Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed', '2-year postoperative recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0017067', 'cui_str': 'Structure of nervous system ganglion'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010043', 'cui_str': 'Corneal ulcer'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",102.0,0.0255936,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Pain Clinic, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Changxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Pain Clinic, Subei People's Hospital, Yangzhou, Jiangsu, 225002, People's Republic of China. Electronic address: 1714452550@qq.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China. Electronic address: zy830226@163.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106025']
1712,32590385,Mechanical Ventilation Strategy Guided by Transpulmonary Pressure in Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Previous studies have suggested that adjusting ventilator settings based on transpulmonary pressure measurements may minimize ventilator-induced lung injury, but this has never been investigated in patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation. We aimed to evaluate whether a transpulmonary pressure-guided ventilation strategy would increase the proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation support in patients with severe acute respiratory distress syndrome.
DESIGN


Single-center, prospective, randomized controlled trial.
SETTING


Sixteen-bed, respiratory ICU at a tertiary academic medical center.
PATIENTS


Severe acute respiratory distress syndrome patients receiving venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


One-hundred four patients were randomized to transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group (n = 52) groups. Two patients had cardiac arrest during establishment of venovenous extracorporeal membrane oxygenation in the lung rest group did not receive the assigned intervention. Thus, 102 patients were included in the analysis.
MEASUREMENTS AND MAIN RESULTS


The proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation in the transpulmonary pressure-guided group was significantly higher than that in the lung rest group (71.2% vs 48.0%; p = 0.017). Compared with the lung rest group, driving pressure, tidal volumes, and mechanical power were significantly lower, and positive end-expiratory pressure was significantly higher, in the transpulmonary pressure-guided group during venovenous extracorporeal membrane oxygenation support. In the transpulmonary pressure-guided group, levels of interleukin-1β, interleukin-6, and interleukin-8 were significantly lower, and interleukin-10 was significantly higher, than those of the lung rest group over time. Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
CONCLUSIONS


A transpulmonary pressure-guided ventilation strategy could increase the proportion of patients with severe acute respiratory distress syndrome successfully weaned from venovenous extracorporeal membrane oxygenation.",2020,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","['102 patients were included in the analysis', 'Severe Acute Respiratory Distress Syndrome Treated With', 'Severe acute respiratory distress syndrome patients receiving', 'Sixteen-bed, respiratory ICU at a tertiary academic medical center', 'patients with severe acute respiratory distress syndrome', 'One-hundred four patients']","['transpulmonary pressure-guided ventilation strategy', 'venovenous extracorporeal membrane oxygenation', 'Mechanical Ventilation Strategy Guided by Transpulmonary Pressure', 'transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation support']","['proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation', 'driving pressure, tidal volumes, and mechanical power', 'cardiac arrest', 'Lung density', 'positive end-expiratory pressure', 'levels of interleukin-1β, interleukin-6, and interleukin-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",104.0,0.101497,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'All authors: Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xuyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Hangyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Haichao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004445']
1713,32590809,"The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder: Study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial.","BACKGROUND


Bipolar disorder (BD) is a chronic and disabling psychiatric disorder. The treatment of BD still remains a significant clinical challenge due to the complex nature of the disease. Nutraceutical therapy as adjunctive role is a promising therapy for BD. Sulforaphane (SFN), a broccoli extract, was reported to be effective for emotional problems and cognitive impairment. However, clinical research of SFN in the treatment of BD was rare. Therefore, this study is designed to evaluate the adjuvant role of SFN in the treatment of BD.
METHODS


This is a randomized, double-blinded, placebo-controlled, parallel-group clinical trial. A total of 100 patients who meet inclusion criteria will be assigned to receive quetiapine plus SFN or quetiapine plus placebo in a 1:1 ratio. The total duration of the study will be 12 weeks including 5 follow ups. The primary outcome is in the Montgomery-Asberg depression rating scale. The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora. Any adverse events will be recorded throughout the trial.
DISCUSSION


This trial will provide evidences to evaluate the efficacy and safety of SFN combined with quetiapine in the treatment of BD patients, as well as the adjuvant role of SFN in combination.
TRIAL REGISTRATION


This study protocol was registered at the Chinese clinical trial registry (ChiCTR2000028706).",2020,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","['bipolar depressive disorder', '100 patients who meet inclusion criteria will be assigned to receive']","['Sulforaphane (SFN), a broccoli extract', 'sulforaphane', 'quetiapine plus SFN or quetiapine plus placebo', 'SFN combined with quetiapine', 'SFN', 'placebo']","['efficacy and safety', 'Montgomery-Asberg depression rating scale', 'quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora']","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C4723687', 'cui_str': 'broccoli extract'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",100.0,0.340506,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","[{'ForeName': 'Congchong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Xingyang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Taizhou Second People's Hospital, Taizhou.""}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}]",Medicine,['10.1097/MD.0000000000020981']
1714,32590831,Long-Axis In-Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"OBJECTIVES


The aim of this study was to compare the occurrence of posterior wall puncture between the long-axis in-plane and the short-axis out-of-plane approaches in a randomized controlled trial of pediatric patients who underwent cardiovascular surgery under general anesthesia.
DESIGN


Prospective randomized controlled trial.
SETTING


Operating room of Osaka Women's and Children's Hospital.
PATIENTS


Pediatric patients less than 5 years old who underwent cardiovascular surgery.
INTERVENTIONS


Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach.
MEASUREMENTS AND MAIN RESULTS


The occurrence of posterior wall puncture was compared between the long-axis in-plane and short-axis out-of-plane approaches for ultrasound-guided central venous catheterization. Patients were randomly allocated to a long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group). After exclusion, 97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups. Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003). First attempt success rates were 67.3% (33/49) and 64.6% (31/48) in the long-axis and short-axis groups, respectively (relative risk, 1.04; 95% CI, 0.78-1.39; p = 0.77). Overall success rates within 20 minutes were 93.9% (46/49) and 93.8% (45/48) in the long-axis and short-axis groups, respectively (relative risk, 0.99; 95% CI, 0.90-1.11; p = 0.98).
CONCLUSIONS


The long-axis in-plane approach for ultrasound-guided central venous catheterization is a useful technique for avoiding posterior wall puncture in pediatric patients, compared with the short-axis out-of-plane approach.",2020,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","['97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups', ""Operating room of Osaka Women's and Children's Hospital"", 'pediatric patients', 'Pediatric Patients', 'pediatric patients who underwent cardiovascular surgery under general anesthesia', 'Pediatric patients less than 5 years old who underwent cardiovascular surgery']","['long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group', 'Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization', 'Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach', 'ultrasound-guided central venous catheterization']","['occurrence of posterior wall puncture', 'success rates', 'Overall success rates', 'Posterior wall puncture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",97.0,0.0729776,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""1Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan. 2Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan. 3Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.""}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': ''}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': ''}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nagai', 'Affiliation': ''}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': ''}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hamaba', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': ''}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ''}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002476']
1715,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1716,32592986,"A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer - The FALUCA study.","OBJECTIVES


Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population.
MATERIALS AND METHODS


From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS).
RESULTS


Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82-1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28-0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46-0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
CONCLUSION


Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy.",2020,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","['patients with NSCLC who have failed second-line chemotherapy', 'Chinese patients with advanced nonsquamous non-small-cell lung cancer ', 'From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study', 'same patient population', 'fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy']",['placebo'],"['Objective response rate and disease control rate', 'Median OS', 'Hypertension', 'fruquintinib prolonged the median OS', 'quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires', 'progression-free survival (PFS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",730.0,0.694568,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires.
","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, China. Electronic address: shunlu@sjtu.edu.cn.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Harbin Medical University Cancer Hospital, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'XuZhou Central Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nantong Tumor Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""The Fifth Medical Center, General Hospital of the People's Liberation Army, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Jiangyin People's Hospital, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Hubei Cancer Hospital, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'West China Hospital of Sichuan University, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Xinjiang Cancer Hospital, China.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Jinling Hospital, Nanjing University School of Medicine, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Shanghai Changhai Hospital, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Northern Jiangsu People's Hospital, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Liaoning Cancer Hospital, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Northern Theater Command, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Ningxia Medical University, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""The Fifth People's Hospital of Shanghai, China.""}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital of Southern Medical University, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, China.'}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'The Fourth Affiliated Hospital of Guangxi Medical University, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Hust, China.'}, {'ForeName': 'Jinji', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guandong Provincial People's Hospital, China.""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, China.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Hangzhou First People's Hospital, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Peking University Third Hospital, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Soochow University, China.'}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan General Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yunnan Cancer Hospital, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.016']
1717,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1718,32615109,"Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial.","BACKGROUND


Indications for liver transplantation for hepatocellular carcinoma are evolving and so-called expanded criteria remain debated. Locoregional therapies are able to downstage hepatocellular carcinoma from beyond to within the Milan criteria. We aimed to investigate the efficacy of liver transplantation after successful hepatocellular carcinoma downstaging.
METHODS


We did an open-label, multicentre, randomised, controlled trial designed in two phases, 2b and 3, at nine Italian tertiary care and transplantation centres. Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision. After an observation period of 3 months, during which sorafenib was allowed, patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors were randomly assigned (1:1) by an interactive web-response system to liver transplantation or non-transplantation therapies (control group). A block randomisation (block size of 2), stratified by centre and compliance to sorafenib treatment, was applied. Liver transplantation was done with whole or split organs procured from brain-dead donors. The control group received sequences of locoregional and systemic treatment at the time of demonstrated tumour progression. The primary outcomes were 5-year tumour event-free survival for phase 2b and overall survival for phase 3. Analyses were by intention to treat. Organ allocation policy changed during the course of the study and restricted patient accrual to 4 years. This trial is registered with ClinicalTrials.gov, NCT01387503.
FINDINGS


Between March 1, 2011, and March 31, 2015, 74 patients were enrolled. Median duration of downstaging was 6 months (IQR 4-11). 29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group. At data cutoff on July 31, 2019, median follow-up was 71 months (IQR 60-85). 5-year tumour event-free survival was 76·8% (95% CI 60·8-96·9) in the transplantation group versus 18·3% (7·1-47·0) in the control group (hazard ratio [HR] 0·20, 95% CI 0·07-0·57; p=0·003). 5-year overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035). The most common registered grade 3-4 serious adverse events were hepatitis C virus recurrence (three [13%] of 23 patients) and acute transplant rejection (two [9%]) in the transplantation group, and post-embolisation syndrome (two [9%] of 22 patients) in the control group. Treatment-related deaths occurred in four patients: two (8%) of 23 patients in the transplantation group (myocardial infarction and multi-organ failure) versus two (9%) of 22 patients in the control group (liver decompensation).
INTERPRETATION


Although results must be interpreted with caution owing to the early closing of the trial, after effective and sustained downstaging of eligible hepatocellular carcinomas beyond the Milan criteria, liver transplantation improved tumour event-free survival and overall survival compared with non-transplantation therapies Post-downstaging tumour response could contribute to the expansion of hepatocellular carcinoma transplantation criteria.
FUNDING


Italian Ministry of Health.",2020,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","['two phases, 2b and 3, at nine Italian tertiary care and transplantation centres', '29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group', 'Between March 1, 2011, and March 31, 2015, 74 patients were enrolled', 'hepatocellular carcinoma after tumour downstaging (XXL', '0·20', 'Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision', 'patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors']","['liver transplantation', 'sorafenib', 'Liver transplantation', 'interactive web-response system to liver transplantation or non-transplantation therapies (control group']","['5-year tumour event-free survival for phase 2b and overall survival', 'overall survival', 'tumour event-free survival', 'hepatitis C virus recurrence', 'acute transplant rejection', 'Median duration of downstaging', '5-year', 'deaths']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",74.0,0.208689,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy. Electronic address: vincenzo.mazzaferro@istitutotumori.mi.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Citterio', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bongini', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Salizzoni', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Romagnoli', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Antonelli', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vivarelli', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gruttadauria', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Di Sandro', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lucà', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Giorgio', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mirabella', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Belli', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fagiuoli', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Martini', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Iavarone', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Svegliati Baroni', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Angelico', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ginanni Corradini', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Volpes', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Regalia', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Droz Dit Busset', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sposito', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30224-2']
1719,32615462,The effect of baclofen on objective and subjective sleep measures in a model of transient insomnia.,"STUDY OBJECTIVES


Insomnia is a common medical complaint. Current pharmacologic treatments have modest efficacy and numerous side effects. Baclofen is a gamma-aminobutyric acid (GABA)b receptor agonist used to treat spasticity in various medical conditions. Several studies noted that baclofen, when used to treat sleep related disorders, resulted in improvement in sleep parameters. Measures of insomnia, however, were not assessed in those studies. To date, baclofen has not been assessed for efficacy in the treatment of insomnia.
METHODS


We randomized 20 healthy subjects to baclofen or placebo in a cross over design. All subjects underwent two polysomnograms (PSG) assessing sleep parameters. Baclofen or placebo was given 90 min prior to lights out in random order for each subject. Lights out occurred two hours earlier than the subject's median habitual bedtime.
RESULTS


Baclofen resulted in significantly less objective wake after sleep onset and stage 1 sleep, and significantly increased total sleep time (TST), sleep efficiency, and stage 3/4 sleep. There was no effect on sleep onset latency (SOL). Self-report variables indicated significantly less subjective awakenings from sleep and increased subjective sleep quality. There was no effect on subjective TST or subjective SOL.
CONCLUSIONS


This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality. These data support the notion that baclofen shows promise as an effective hypnotic drug.",2020,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,['20 healthy subjects to'],"['baclofen', 'baclofen or placebo', 'Baclofen or placebo', 'placebo']","['subjective awakenings from sleep and increased subjective sleep quality', 'sleep parameters', 'sleep onset latency (SOL', 'subjective TST or subjective SOL', 'total sleep time (TST), sleep efficiency, and stage 3/4 sleep', 'objective wake after sleep onset and stage 1 sleep', 'sleep quality', 'objective and subjective sleep measures']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.028149,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,"[{'ForeName': 'Samih', 'Initials': 'S', 'LastName': 'Raad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Samih-Raad@ouhsc.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Wilkerson', 'Affiliation': 'Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: Meredith-Wilkerson@ouhsc.edu.'}, {'ForeName': 'Kellie R', 'Initials': 'KR', 'LastName': 'Jones', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Kellie-Jones@ouhsc.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'University of Oklahoma Health Sciences Center, Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: worr@lhsi.net.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.028']
1720,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1721,32615487,A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents.,"INTRODUCTION


School-based education is a potentially effective approach for improving mental health literacy (MHL) in adolescents. This study evaluated the effects of the ""Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL in adolescents in a quasi-cluster randomized controlled trial.
METHODS


A total of 975 high school first graders (age 15-16) in Japan were allocated to classes such that gender and academic achievement ratios were almost equivalent at the time of admission to the high school. They were assigned at the class level to the SMHLP (n = 364 from 10 classes) or a control group (n = 611 from 17 classes). The program consisted of a 50-minute session and was delivered by a school teacher. The students completed a self-report questionnaire at 3 time points: pre-, (immediately) post- and 2-month follow-up. Outcomes included ""Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers"". Mixed effects modeling was employed for analyses.
RESULTS


Scores of all outcomes were significantly improved in the intervention group compared to the control group post-intervention (p < .001). These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05). Questionnaire scores did not differ between groups at baseline.
CONCLUSIONS


The effect of the SMHLP was confirmed in grade 10 students. Brief, yet effective programs can be a viable option to promote understanding of mental health problems and have the potential to be incorporated into regular school curriculum. "".",2020,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"['A total of 975 high school first graders (age 15-16) in Japan', 'grade 10 students', 'adolescents']","['SMHLP', 'classroom-based mental health literacy educational intervention', 'Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL']","['Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers', 'Questionnaire scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0024851', 'cui_str': 'Marshall Islands'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",975.0,0.047281,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: yama-s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8553, Japan. Electronic address: ojio@ncnp.go.jp.'}, {'ForeName': 'Jerome Clifford', 'Initials': 'JC', 'LastName': 'Foo', 'Affiliation': 'Central Institute of Mental Health, Department of Genetic Epidemiology in Psychiatry, Medical Faculty Mannheim, University of Heidelberg, J5 68159, Mannheim, Germany. Electronic address: jeromefoo@gmail.com.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Michigami', 'Affiliation': 'Saitama Prefectural Soka Higashi High School, 1110-1 Kakinoki-cho, Soka, Saitama, 340-0001, Japan. Electronic address: michigami@msj.biglobe.ne.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Center for Research and Development on Transition from Secondary to Higher Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: usami_s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Taruto', 'Initials': 'T', 'LastName': 'Fuyama', 'Affiliation': 'Graduate School of Film and New Media, Tokyo University of the Arts, 4-23, Kaigan-dori, Naka-ku, Yokohama, Kanagawa, 231-0002, Japan. Electronic address: fuyan@taruto.com.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Onuma', 'Affiliation': 'Department of Health and Nutrition, Laboratory of Practical Yogo Science, Kagawa Education Institute of Nutrition, 3-9-21 Chiyoda, Sakado, Saitama, 350-0288, Japan. Electronic address: kokumichan@gmail.com.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Oshima', 'Affiliation': 'Office for Mental Health Support, Division for Counseling and Support, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: rxg01737@qg8.so-net.ne.jp.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Tokyo Metropolitan Institute of Medical Science, 2-1-6, Kamikitazawa, Setagaya-ku, Tokyo, 156-8506, Japan. Electronic address: sandou-tky@umin.ac.jp.'}, {'ForeName': 'Fumiharu', 'Initials': 'F', 'LastName': 'Togo', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: tougou@p.u-tokyo.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: psytokyo577@gmail.com.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.05.002']
1722,32615488,Effects of the juçara fruit supplementation on metabolic parameters in individuals with obesity: a double-blind randomized controlled trial.,"Adipose tissue inflammation has been proposed as a central mechanism connecting obesity with its metabolic and vascular complications due to the imbalance in the expression of several hormones and adipokines. Berries rich in polyphenols and unsaturated fatty acids have been able to prevent both obesity and adipose tissue inflammation, improving metabolic functions in human subjects and animal models of obesity. Juçara has been considered a super fruit owing to its nutritional composition and relevant biological activities with an interesting response in animals. Thus, we aimed to verify the potential antiobesogenic effect of juçara supplementation in humans. We conducted a double-blind, placebo-controlled, randomized trial with 35 adults with obesity of both sexes. They were assessed for resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines. Subsequently, they were randomized into two groups to use or not (placebo) 5 g lyophilized juçara for 6 weeks. Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin. Besides, juçara supplementation, high-density lipoprotein cholesterol and neck circumference were predictors to explain the enhancement in adiponectin. Juçara supplementation was determinant to improve adiponectin levels, and it may be considered a novel strategy for the treatment of obesity-related metabolic diseases.",2020,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","['35 adults with obesity of both sexes', 'individuals with obesity', 'humans']","['juçara fruit supplementation', 'juçara supplementation', 'not (placebo', 'placebo']","['body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin', 'resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines', 'juçara supplementation, high-density lipoprotein cholesterol and neck circumference', 'metabolic parameters', 'adiponectin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",35.0,0.113597,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","[{'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Flygare', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Departamento de Medicina Cardiovascular, Angiocorpore Instituto de Medicina Cardiovascular, Santos, SP, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil; Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil. Electronic address: lucianapisani@gmail.com.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108430']
1723,32616022,Sources of potential bias when combining routine data linkage and a national survey of secondary school-aged children: a record linkage study.,"BACKGROUND


Linking survey data to administrative records requires informed participant consent. When linkage includes child data, this includes parental and child consent. Little is known of the potential impacts of introducing consent to data linkage on response rates and biases in school-based surveys. This paper assessed: i) the impact on overall parental consent rates and sample representativeness when consent for linkage was introduced and ii) the quality of identifiable data provided to facilitate linkage.
METHODS


Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK. Schools agreeing to participate were randomized 2:1 to receive versus not receive the data linkage question. Survey responses from consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records). Parental withdrawal rates were calculated for linkage and non-linkage samples. Multilevel logistic regression models were used to compare characteristics between: i) consenters and non-consenters; ii) successfully and unsuccessfully linked students; and iii) the linked cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts.
RESULTS


The sub-sample comprised 64 eligible schools (out of 193), with data linkage piloted in 39. Parental consent was comparable across linkage and non-linkage schools. 48.7% (n = 9232) of students consented to data linkage. Modelling showed these students were more likely to be younger, more affluent, have higher positive mental wellbeing, and report fewer risk-related behaviours compared to non-consenters. Overall, 69.8% of consenting students were successfully linked, with higher rates of success among younger students. The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
CONCLUSIONS


Introducing data linkage within a national survey of adolescents had no impact on study completion rates. However, students consenting to data linkage, and those successfully linked, differed from non-consenting students on several key characteristics, raising questions concerning the representativeness of linked cohorts. Further research is needed to better understand decision-making processes around providing consent to data linkage in adolescent populations.",2020,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
","['secondary school-aged children', '64 eligible schools (out of 193), with data linkage piloted in 39', 'consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records', 'cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts', 'Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK']",[],"['mental health diagnoses', 'positive mental wellbeing', 'Parental withdrawal rates', 'specialist contacts']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242239', 'cui_str': 'Data Linkage'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0463772,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK. morgank22@cardiff.ac.uk.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hewitt', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Del Pozo-Banos', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'John', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01064-1']
1724,32616026,Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial.,"BACKGROUND


Reduction mammaplasty is among the most commonly performed procedures in plastic surgery. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. This trial aims to compare the influence of the use of prophylatic antibiotics as a single dose or for 24 h on surgical site infection rates following reduction mammaplasty.
METHODS


Randomized trial of non-inferiority, with two parallel groups. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to the placebo group that will receive antibiotics only at the anesthesia induction (n = 73) or to the antibiotics group that will receive antibiotics at the anesthesia induction and for 24 h (n = 73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.
DISCUSSION


Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics. However, the duration of antibiotic prophylaxis remains a point to be clarified. This study will test the hypothesis that maintaining the use of antibiotics for 24 h does not reduce infection rates compared to the use of a single preoperative dose.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04079686 . Registered on September 6, 2019.",2020,"Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics.","['146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled']","['antibiotics group that will receive antibiotics at the anesthesia induction', '24\u2009h antibiotic prophylaxis', 'prophylatic antibiotics', 'placebo']",['infection rates'],"[{'cui': 'C0020565', 'cui_str': 'Hypertrophy of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",146.0,0.171198,"Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics.","[{'ForeName': 'Daniela Francescato', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': 'Translational Surgery Graduate Program, Universidade Federal de São Paulo, São Paulo, Brazil. danielafveiga@gmail.com.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'da Silva Garcia', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'José Wilson', 'Initials': 'JW', 'LastName': 'Moreira-Filho', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Evelyne Borges', 'Initials': 'EB', 'LastName': 'de Mattos Andrade', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Juliano', 'Affiliation': 'Department of Bioestatistics, Universidade Federal de São Paulo, and Universidade de Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Veiga-Filho', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Lydia Masako', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': 'Translational Surgery Graduate Program, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Trials,['10.1186/s13063-020-04539-0']
1725,32616063,Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial.,"OBJECTIVES


The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group. 6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2.
TRIAL DESIGN


Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy. Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1.
PARTICIPANTS


Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case. Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria. • Presenting with fever (≥37.5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact* of a SARS-CoV-2 confirmed or suspected case in the past 14 days • More than 12 weeks of gestation (dated by ultrasonography) • Agreement to deliver in the study hospitals Exclusion criteria • Known hypersensitivity to HCQ or other 4-amonoquinoline compounds • History of retinopathy of any aetiology • Concomitant use of digoxin, cyclosporine, cimetidine • Known liver disease • Clinical history of cardiac pathology including known long QT syndrome • Unable to cooperate with the requirements of the study • Participating in other intervention studies • Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results. Assignment of participants to study groups will be as follows: • SARS-CoV-2-PCR confirmed, infected pregnant women: a. symptomatic (n=100) b. asymptomatic (n=100) • SARS-CoV-2 PCR negative pregnant women in contact* with a SARS-CoV-2-infected confirmed or suspected case (n=514). *The ECDC definition of close contact will be followed. The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid.
INTERVENTION AND COMPARATOR


Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days).
MAIN OUTCOMES


The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed).
RANDOMISATION


Allocation of participants to study arms will be done centrally by the trial's Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization. This method will ensure balanced allocation to both arms. The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site. Each number will be related to a treatment number, which assigns them to one of the study arms.
BLINDING (MASKING)


Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment. Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm.
TRIAL STATUS


Protocol version 1.0, from May 8 th , 2020. Recruitment is ongoing (first patient recruited the 19 th  May 2020 and recruitment end anticipated by December 2020).
TRIAL REGISTRATION


EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562 , retrospectively registered 1 June 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case.,"['2020-001587-29, registered 2 April 2020', 'b. asymptomatic (n=100', 'five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la', 'Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case', 'SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg', '200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm', 'SARS-CoV-2-infected pregnant women', 'pregnant women in contact with an infected or suspected case', 'asymptomatic SARS-CoV-2-infected pregnant women', 'infected pregnant women with mild symptoms', 'infected pregnant women: a. symptomatic (n=100', 'pregnant women']","['Santa Creu', 'cimetidine', 'Hydroxychloroquine', 'HCQ', 'hydroxychloroquine (HCQ', 'maternal SARS-CoV-2 infection', 'Study tablets (HCQ and placebo', 'digoxin, cyclosporine', 'HCQ or placebo, ratio 1:1', '4-amonoquinoline', 'gestation (dated by ultrasonography', 'placebo']","['mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache', 'safety and efficacy', 'safety and tolerability', 'number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3536619', 'cui_str': 'Nasopharyngeal and oropharyngeal swab'}]",,0.422207,To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case.,"[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'González', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain. raquel.gonzalez@isglobal.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Otero', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Pons-Duran', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marbán-Castro', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goncé', 'Affiliation': 'BCNATAL | Barcelona Center for Maternal Fetal and Neonatal Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Llurba', 'Affiliation': 'Obstetrics and Gynecology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Mar Gil', 'Affiliation': 'Obstetrics and Gynecology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Rodríguez-Zambrano', 'Affiliation': 'HM Puerta del Sur, Móstoles, Madrid, Spain.'}, {'ForeName': 'Haily', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Ramírez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Menendez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}]",Trials,['10.1186/s13063-020-04557-y']
1726,32616067,ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


PRIMARY OBJECTIVE: To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.
SECONDARY OBJECTIVES


1) To determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers. 2) To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology) 3) To compare the percentage of COVID-19 positive individuals with current testing methods versus serologically-proven COVID-19 in each trial arm 4) To compare COVID-19 disease severity in each trial arm 5) To compare recovery time from COVID-19 infection in each trial arm EXPLORATORY OBJECTIVES: 1) To determine compliance (as measured by trough pharmacokinetic hydroxychloroquine levels) on COVID-19 positive tests 2) To determine if genetic factors determine susceptibility to COVID-19 disease or response to treatment 3) To determine if blood group determines susceptibility to COVID-19 disease 4) To compare serum biomarkers of COVID-19 disease in each arm TRIAL DESIGN: Double-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trial PARTICIPANTS: National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19. Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19.
INCLUSION CRITERIA


To be included in the trial the participant MUST: 1) Have given written informed consent to participate 2) Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA: The presence of any of the following will mean participants are ineligible: 1) Known COVID-19 positive test at baseline (if available) 2) Symptomatic for possible COVID-19 at baseline 3) Known hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted) 10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 11) Currently taking any of the following contraindicated medications: Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine 13) Currently breastfeeding 14) Unable to be followed-up during the trial 15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit 16) Not able to use or have access to a modern phone device/web-based technology 17) Any other clinical reason which may preclude entry in the opinion of the investigator INTERVENTION AND COMPARATOR: Interventions being evaluated are: A) Daily hydroxychloroquine or B) Weekly hydroxychloroquine or C) Placebo The maximum treatment period is approximately 13 weeks per participant. Hydroxychloroquine-identical matched placebo tablets will ensure that all participants are taking the same number and dosing regimen of tablets across the three trial arms. There is no variation in the dose of hydroxychloroquine by weight. The dosing regimen for the three arms of the study (A, B, C) are described in further detail below. Arm A: Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine - weekly dosing). Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading phase - 400mg (2 x 200mg tablets) taken twice a day for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg tablet) taken once daily, every day for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7 th  day) for 90 days (~3 months) Arm B: Active Hydroxychloroquine (- weekly dosing and placebo matched hydroxychloroquine - daily dosing.) Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading Phase - 400mg (2 x 200mg tablets) taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg tablets) taken once a week on the same day each week (every 7 th  day) for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Arm C: Matched placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing.) Form: Table. Route: Oral. Frequency: Matched placebo hydroxychloroquine - daily dosing: Days 1-2: Loading Phase - 2 tablets taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Matched placebo hydroxychloroquine - weekly dosing: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7th day) for 90 days (~3 months) A schematic of the dosing schedule can be found in the full study protocol (Additional File 1).
MAIN OUTCOMES


Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test) RANDOMISATION: Participants will be randomised to either hydroxychloroquine dosed daily with weekly placebo, HCQ dosed weekly with daily placebo, or placebo dosed daily and weekly. Randomisation will be in a 3:3:2 ratio [hydroxychloroquine-(daily), hydroxychloroquine-(weekly), placebo], using stratified block randomisation. Random block sizes will be used, and stratification will be by study site.
BLINDING (MASKING)


Participants and trial investigators consenting participants, delivering trial assessments and procedures will be blinded to intervention.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A sufficient number of participants will be enrolled so that approximately 1000 participants in total will have data suitable for the primary statistical analysis. It is anticipated that approximately 1,200 participants will need to be enrolled in total, to allow for a 20% dropout over the period of the trial. This would result in approximately 450:450:300 participants randomised to hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo daily and weekly.
TRIAL STATUS


V 1.0, 7 th  April 2020 EU Clinical Trials Register EudraCT Number: 2020-001331-26 Date of registration: 14 th  April 2020 Trial registered before first participant enrolment. Trial site is Cambridge University Hospitals NHS Foundation Trust. Recruitment started on 11 th  May 2020. It is anticipated that the trial will run for 12 months. The recruitment end date cannot yet be accurately predicted.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,There is no variation in the dose of hydroxychloroquine by weight.,"['V 1.0, 7 th  April 2020', '10', 'Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA', ""or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted"", 'Frequency', ' 2020-001331-26 Date of registration', '14 th  April 2020', 'approximately 1,200 participants will need to be enrolled in total', 'National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19', 'frontline healthcare workers', 'Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19', 'COVID-19 positive tests 2', '1']","['placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing', 'Placebo', 'Active hydroxychloroquine', 'hydroxychloroquine', 'Weekly hydroxychloroquine or C', 'Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine 13', 'Hydroxychloroquine-identical matched placebo tablets', 'placebo hydroxychloroquine', 'placebo, HCQ dosed weekly with daily placebo, or placebo', 'placebo hydroxychloroquine - daily dosing', 'hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo', 'Placebo hydroxychloroquine', 'Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12', 'hydroxychloroquine or B', 'hydroxychloroquine, chloroquine', 'placebo']","['Dose and Frequency', 'Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0017551', 'cui_str': ""Gilbert's syndrome""}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",1200.0,0.731188,There is no variation in the dose of hydroxychloroquine by weight.,"[{'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'McEniery', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK. mf503@medschl.cam.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miles', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Kaloyirou', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hubsch', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}]",Trials,['10.1186/s13063-020-04543-4']
1727,32616128,[Anhydrous Ethanol Improves Efficiency of Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules:A Prospective Randomized Controlled Trial].,"Objective  To investigate the value of injecting a small amount of absolute ethanol into the benign solid nodules of the thyroid before radiofrequency ablation(RFA)to improve the efficiency of radiofrequency ablation.  Methods  A total of 98 eligible patients(98 nodules)with pathologically confirmed benign solid nodules who were treated in our center from December 2016 to February 2018 were included and randomized into ethanol ablation(EA)combined with radiofrequency ablation(RFA)group(EA+RFA group)and RFA group,with 49 patients in each group.Routine ultrasound,contrast-enhanced ultrasound(CEUS),and thyroid function test were performed before treatment and 1,3,6,and 12 months after treatment.The general information,treatment time,ablation energy,ablation power,postoperative nodule volume reduction ratio(VRR),symptom score(SS)and cosmetic score(CS),thyroid function level,and incidence of complications were compared between these two groups.  Results  The mean treatment time [(441.30±243.31)s  vs. (790.70±349.82)s; t = 4.403,  P =0.000],mean ablation energy [(3.92±2.01)kJ  vs. (5.15±2.12)kJ; t =2.709,  P =0.009],and mean ablation power [(6.07±1.44)W  vs. (7.30±1.29)W; t =3.612,  P =0.006] were significantly lower in the EA+RFA group than in the RFA group.At 3,6 and 12 months after surgery,the VRR in the EA+RFA group was(57.73±11.07)%( t =-3.16,  P <0.001),(64.40±10.56)%( t =-5.45,  P <0.001),and(77.29±8.48)%( t =-10.46,  P <0.001),respectively;the VRR in the RFA group was(55.44±13.01)%( t =-1.76,  P <0.001),(65.28±11.33)%( t =-5.09,  P <0.001),and(75.17±9.84)%( t =-8.93,  P <0.001),which were significantly smaller than those before surgery.There was no significant difference in VRR between the EA+RFA group and the RFA group at 1( t =3.41,  P =0.33),3( t =2.05,  P =0.21),6( t =2.77,  P =0.49),and 12 months( t =5.05,  P =0.10)after treatment.During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15); t =9.63,  P <0.001] and the CS[(1.39±0.77) vs .(3.32±0.61); t =10.09,  P =0.004]at 12 months after surgery were significantly lower than those before surgery.In the RFA group,SS [(1.63±1.04) vs .(5.90±1.79); t =12.72,  P <0.001] and CS [(1.64±0.83) vs .(3.15±0.72); t =8.13,  P =0.012] at 12 months after surgery were also significantly lower than those before surgery.The CSS in the EA+RFA group was significantly lower than that in the RFA group [(0.93±0.55) vs .(2.44±0.53); t =-11.70,  P =0.007].Both groups had no significant change in thyroid function during the follow-up period,and no serious complications were observed.  Conclusion  Anhydrous alcohol injection can effectively improve the efficiency of radiofrequency ablation in treating benign solid thyroid nodules and is effective in reducing nodule volume,alleviating compressive symptoms,and decreasing cosmetic discomfort.",2020,"During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15);","['98 eligible patients(98 nodules)with pathologically confirmed benign solid nodules who were treated in our center from December 2016 to February 2018', 'group,with 49 patients in each group', 'Benign Thyroid Nodules']","['EA+RFA', '0.001),and(77.29±8.48', 'ethanol ablation(EA)combined with radiofrequency ablation(RFA)group(EA+RFA group)and RFA', 'Anhydrous Ethanol', 'Anhydrous alcohol injection']","['serious complications', 'Efficiency of Radiofrequency Ablation', 'VRR', 'cosmetic score(CS),thyroid function level,and incidence of complications', 'general information,treatment time,ablation energy,ablation power,postoperative nodule volume reduction', 'efficiency of radiofrequency ablation', 'cosmetic discomfort', 'thyroid function', 'recurrence of nodules', 'mean treatment time ']","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0085733', 'cui_str': 'Absolute Alcohol'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1272583', 'cui_str': 'Ablation power'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0379348,"During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15);","[{'ForeName': 'Yaqiong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}]",Zhongguo yi xue ke xue yuan xue bao. Acta Academiae Medicinae Sinicae,['10.3881/j.issn.1000-503X.11512']
1728,32616489,"Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial).","INTRODUCTION


Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as 'idiopathic', except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%-87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate.
METHODS AND ANALYSIS


We designed a multicentre, randomised, double-blind, placebo-controlled clinical trial. We aimed to include 1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility. The couple will either start or has already been started with fertility treatment, that is, expectative management (duration of 6 months), intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment. Male participants will be randomised in either the Impryl or the placebo group, with identical appearance of the tablets to be distributed (doses: one tablet each day), for a total duration of maximal 6 months. Patients can start directly with fertility treatment and/or natural conception. The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window between randomisation up to and including month 6 of intervention use. Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count. Furthermore the number of pregnancies conceived in the optimal intervention time window (after full spermatogenesis of 72 days), overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events are documented within the study period of 15 months.
ETHICS AND DISSEMINATION


The protocol is approved by the local medical ethical review committee at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects. Findings will be shared with the academic and medical community, funding and patient organisations in order to contribute to optimisation of medical care and quality of life for patients with infertility.
TRIAL REGISTRATION NUMBERS


NCT03337360 and NTR6551.",2020,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","['men of infertile couples', 'male infertile cases', 'patients with infertility', 'Male participants', 'male fertility', '1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility']","['intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment', 'nutritional supplement (Impryl', 'placebo']","['change in semen parameters', 'overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events', 'number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window', 'IUI/IVF/ICSI group, based on (prewash) total motile sperm count']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0429916', 'cui_str': 'Number of miscarriages'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033010', 'cui_str': 'Pregnancy confirmed'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",1200.0,0.404305,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","[{'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Smits', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands roos.smits@radboudumc.nl.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""D'Hauwers"", 'Affiliation': 'Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Didi', 'Initials': 'D', 'LastName': 'Braat', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Fleischer', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035069']
1729,32616883,Exercise intervention lowers aberrant serum WISP-1 levels with insulin resistance in breast cancer survivors: a randomized controlled trial.,"Insulin resistance is associated with increased risk for and recurrence of breast cancer. Recently, Wnt1-inducible signaling pathway protein-1 (WISP-1) was reported to impair glucose metabolism and insulin sensitivity. In various cancer tissues, Wnt signaling is upregulated and induces further oncogenic and metastatic activity. However, the effects of exercise on serum levels of WISP-1 and its upstream β-catenin have not been studied in cancer patients. We investigated the effects of exercise training on Wnt signaling and insulin sensitivity in breast cancer survivors (BCS). This single-center trial randomized 46 BCS into either 12-week exercise or control groups (1:1), and included an additional 12 age-matched healthy women. Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles were evaluated before and after the intervention. Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects. There was a positive correlation between β-catenin and WISP-1 levels. Exercise training in BCS significantly reduced body fat and waist circumference and enhanced aerobic and muscular fitness. Exercise decreased β-catenin and WISP-1 levels and improved gluco-lipid profiles. There was a notable correlation between changes in HOMA-IR indexes and serum WISP-1, but not with β-catenin during the exercise intervention. In conclusion, a 12-week community-based exercise intervention resulted in significant reductions in serum β-catenin and WISP-1 levels, accompanied by favorable improvements in body composition, physical fitness, and biochemical parameters in BCS. We also highlight that this is the first report concerning effects of exercise on circulating β-catenin and WISP-1 levels and correlations between WISP-1 and insulin sensitivity, which could be important for determining prognoses for BCS.",2020,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"['12 age-matched healthy women', 'breast cancer survivors', 'breast cancer survivors (BCS', 'cancer patients']","['exercise training', 'Exercise intervention', 'Exercise training', 'community-based exercise intervention']","['body composition, physical fitness, and biochemical parameters in BCS', 'Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles', 'Serum β-catenin and WISP-1 concentrations', 'body fat and waist circumference and enhanced aerobic and muscular fitness', 'HOMA-IR indexes and serum WISP-1', 'β-catenin and WISP-1 levels and improved gluco-lipid profiles', 'serum β-catenin and WISP-1 levels', 'β-catenin and WISP-1 levels']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1449212', 'cui_str': 'WISP1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",46.0,0.0220849,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"[{'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Mitohormesis Research Center, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Tae Ho', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'In Deok', 'Initials': 'ID', 'LastName': 'Kong', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea. kong@yonsei.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-67794-w']
1730,32560744,"AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial.","OBJECTIVES


Phase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform. Phase II - To determine the efficacy and safety of each candidate entered into the platform, compared to the current Standard of Care (SoC), and recommend whether it should be evaluated further in a later phase II & III platforms.
TRIAL DESIGN


AGILE-ACCORD is a Bayesian multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19. Designed as a master protocol with each candidate being evaluated within its own sub-protocol (Candidate Specific Trial (CST) protocol), randomising between candidate and SoC with 2:1 allocation in favour of the candidate (N.B the first candidate has gone through regulatory approval and is expected to open to recruitment early summer 2020). Each dose will be assessed for safety sequentially in cohorts of 6 patients. Once a phase II dose has been identified we will assess efficacy by seamlessly expanding into a larger cohort.
PARTICIPANTS


Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We will include both severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA. If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. Participants will be recruited from England, North Ireland, Wales and Scotland.
INTERVENTION AND COMPARATOR


Comparator is the current standard of care (SoC), in some CSTs plus placebo. Candidates that prevent uncontrolled cytokine release, prevention of viral replication, and other anti-viral treatment strategies are at various stages of development for inclusion into AGILE-ACCORD. Other CSTs will be added over time. There is not a set limit on the number of CSTs we can include within the AGILE-ACCORD Master protocol and we will upload each CST into this publication as each opens to recruitment.
MAIN OUTCOMES


Phase I: Dose limiting toxicities using Common Terminology Criteria for Adverse Events v5 Grade ≥3 adverse events. Phase II: Agreed on a CST basis depending on mechanism of action of the candidate and patient population. But may include; time to clinical improvement of at least 2 points on the WHO 9-point category ordinal scale [measured up to 29 days from randomisation], progression of disease (oxygen saturation (SaO 2)  <92%) or hospitalization or death, or change in time-weighted viral load [measured up to 29 days from randomisation].
RANDOMISATION


Varies with CST, but default is 2:1 allocation in favour of the candidate to maximise early safety data.
BLINDING (MASKING)


For the safety phase open-label although for some CSTs may include placebo or SoC for the efficacy phase.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Varies between CSTs. However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
TRIAL STATUS


Master protocol version number v5 07 May 2020, trial is in setup with full regulatory approval and utilises several digital technology solutions, including Medidata's Rave EDC [electronic data capture], RTSM for randomisation and patient eConsent on iPads via Rave Patient Cloud. The recruitment dates will vary between CSTs but at the time of writing no CSTs are yet open for recruitment.
TRIAL REGISTRATION


EudraCT 2020-001860-27 14 th  March 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
","['27 14 th  March 2020', 'Participants will be recruited from England, North Ireland, Wales and Scotland', 'Patient populations can vary between CSTs, but the main eligibility criteria include adult patients (≥18 years) who have laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'severe and mild-moderate patients defined as follows: Group A (severe disease) - patients with WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, non-invasive ventilation or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (hospitalised, ventilation and additional organ support); Group B (mild-moderate disease) - ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO 2 ) >94% RA', 'COVID-19', '2020-001860']","['EudraCT', 'placebo']","['WHO 9-point category ordinal scale', 'efficacy and safety', 'progression of disease (oxygen saturation (SaO 2)  <92%) or hospitalization or death, or change in time-weighted viral load']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.176754,"However simulations have shown that around 16 participants are necessary to determine futility or promise of a candidate at a given dose (in efficacy evaluation alone) and between 32 and 40 participants are required across the dose-finding and efficacy evaluation when capping the maximum number of participants contributing to the evaluation of a treatment at 40.
","[{'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK. G.O.Griffiths@soton.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fitzgerald', 'Affiliation': 'Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University and University of Cambridge, Lancaster, Lancashire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Ellice', 'Initials': 'E', 'LastName': 'Marwood', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Ewings', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Condie', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wrixon', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norton', 'Affiliation': 'Medidata Solutions, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yeats', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'Southampton CTU, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Darby-Dowman', 'Affiliation': 'Cancer Research UK Centre for Drug Development, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Walker', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04473-1']
1731,32589302,Effects of chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years and older: A randomised assessor-blind trial.,"Chewing exercises have been applied in clinical settings to improve the occlusal force and function of the masseter muscle in elderly individuals. However, the clinical relevance and effects of chewing exercises are unclear. This study aimed to investigate the effects of bilateral chewing exercises on the occlusal force and masseter muscle thickness in community-dwelling Koreans aged 65 years. Forty community-dwelling healthy elderly individuals were enrolled in this study. They were assigned to the experimental or the control group. The experimental group performed chewing exercises using medical equipment developed to facilitate such exercises. The chewing exercises were divided into isometric and isotonic types and were performed for 20 min/d, 5 days/wk, for 6 weeks. The control group did not perform any chewing exercises. The outcome measures were occlusal force and masseter muscle thickness, which were evaluated using an occlusometer and ultrasound device, respectively. A paired t test and an independent t test were used to evaluate the training effects. Within-group comparisons showed that occlusal force and masseter muscle thickness improved significantly in the experimental group (P < .001 for both), while the control group showed no significant improvements (P = .098 and .130). Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (P < .05 for both) compared to the control group. These results suggest that chewing exercises are effective in improving occlusal force and masseter muscle thickness in healthy elderly individuals.",2020,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group.
","['elderly individuals', 'community-dwelling Koreans aged 65 years and older', 'community-dwelling Koreans aged 65 years', 'Forty community-dwelling healthy elderly individuals', 'healthy elderly individuals']","['chewing exercises using medical equipment developed to facilitate such exercises', 'chewing exercises', 'bilateral chewing exercises', 'control group did not perform any chewing exercises']",['occlusal force and masseter muscle thickness'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0589278', 'cui_str': 'Chewing exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0261273,"Between-group comparisons showed that the experimental group had a greater increase in occlusal force and masseter muscle thickness (p < 0.05 for both) compared to the control group.
","[{'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Multidisplinary Radiological Science, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Samsung Medical Center, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Se-Hyun', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Dental Hygiene, DongJu College, Busan, South Korea.'}, {'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon, South Korea.'}, {'ForeName': 'YoungJin', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Multidisplinary Radiological Science, Dongseo University, Busan, South Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, South Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.13036']
1732,32589939,Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.,"PURPOSE


We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity.
PATIENTS AND METHODS


This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery.
RESULTS


Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
CONCLUSIONS


A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.",2020,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","['patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity', 'adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis', 'patients with bilateral mandibular fracture', '315 patients enrolled', 'Bilateral Mandibular Fractures']","['rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation', 'nonrigid fixation group', 'rigid and nonrigid fixation', 'Rigid and Nonrigid Fixation Versus Nonrigid Fixation']","['complication rates', 'Helkimo dysfunction index and mandibular mobility index', 'complication risk', 'overall complication rate', 'complications within 6\xa0weeks after surgery', 'complication rate', 'complications within 3\xa0months, Helkimo dysfunction index, and mandibular mobility', 'complication rates and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",315.0,0.151617,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","[{'ForeName': 'Vivesh', 'Initials': 'V', 'LastName': 'Rughubar', 'Affiliation': 'Head, Clinical Unit, Maxillofacial and Oral Surgery, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Vares', 'Affiliation': 'Professor, Head, and Chair of Surgical Dentistry & Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Priyadeshni', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Dentist, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Filipsky', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Creanga', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Hospital Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Alkhalil', 'Affiliation': 'Head, Department Oral and Maxillofacial Surgery and CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Kormi', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Päijät-Häme Central Hospital, Päijät-Häme Joint Authority of Health and Wellbeing, Lahti, Finland (currently), and, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hanken', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Asklepios Hospital North, Faculty of Medicine, Semmelweis University Campus Hamburg, Hamburg, Germany (currently), and Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alvaro Rivero', 'Initials': 'AR', 'LastName': 'Calle', 'Affiliation': 'Consultant, Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Wenko', 'Initials': 'W', 'LastName': 'Smolka', 'Affiliation': 'Senior Surgeon, Department of Oral & Maxillofacial Surgery, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Chief of Oral and Maxillofacial Surgery, Division of Oral and Maxillofacial Surgery, Mount Sinai Hospital, New York City, NY.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csáki', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Ministry of Defense Health Centre, Budapest, Hungary.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Sánchez-Aniceto', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez', 'Affiliation': 'Associate Professor and Program Director, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carl-Peter', 'Initials': 'CP', 'LastName': 'Cornelius', 'Affiliation': 'Associate Professor, Ludwig-Maximilians University, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie, Munich, Germany.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alani', 'Affiliation': 'Specialist, CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vlad', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kontio', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Professor and Chair of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX. Electronic address: ellise3@uthscsa.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.012']
1733,32592830,Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women.,"OBJECTIVE


The aim of this study was to compare the effects of 12 weeks of traditional resistance training (TRT) or resistance training using Cluster-set (CS) on functional performance and physical fitness of postmenopausal and elderly women.
METHODS


Participants (61.1 ± 4.9 years, body mass 64.5 ± 1.8 kg, height 155.7 ± 4.7 cm) were randomized to TRT (n = 35) or CS (n = 31). Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests were performed before and after 12 weeks of training. The difference between protocols was the structure of rest intervals. The TRT group performed 120 s of rest between sets of 8 repetitions, while the CS performed 30 s of rest after every 2 repetitions. Two-way ANOVA with repeated measures was applied for each variable and, when needed, the Bonferroni post hoc was used. Statistical significance was set at p < 0.05.
RESULTS


No group by time interaction was found for any variable. Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
CONCLUSION


Considering that both CS and TRT methods were equally effective to improve the physical fitness and functionality of elderly women, the decision of which protocol to use should be based on individual preferences and practical aspects.",2020,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
","['Participants (61.1\u202f±\u202f4.9\u202fyears, body mass 64.5\u202f±\u202f1.8\u202fkg, height 155.7\u202f±\u202f4.7\u202fcm', 'postmenopausal and elderly women', 'elderly women']","['traditional resistance training (TRT) or resistance training using Cluster-set (CS', 'CS', 'Cluster-sets resistance training', 'TRT']","['Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests', 'countermovement jump', '1 repetition maximum (RM) bench press', '1RM leg press', 'standing long jump', 'plank time', 'functional performance and physical fitness', 'squat jump']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.024454,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001).
","[{'ForeName': 'Rayra Khalinka Neves', 'Initials': 'RKN', 'LastName': 'Dias', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Eduardo Macedo', 'Initials': 'EM', 'LastName': 'Penna', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará.'}, {'ForeName': 'Adria Samara Negrão', 'Initials': 'ASN', 'LastName': 'Noronha', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Antenor Barbosa Calandrini', 'Initials': 'ABC', 'LastName': 'de Azevedo', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Paulo Viana', 'Initials': 'PV', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará. Electronic address: vcoswig@ufpa.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111011']
1734,32597041,Comparison of Postextubation Outcomes Associated with High-Flow Nasal Cannula vs. Conventional Oxygen Therapy in Patients at High Risk of Reintubation: a Randomized Clinical Trial.,"BACKGROUND


Liberation and extubation are important for patients supported by mechanical ventilation. Extubation success is related to the duration of an intensive care unit (ICU) stay and mortality rate. High-flow nasal cannula (HFNC) oxygen therapy has physiological and clinical benefits in respiratory care. The present study compared clinical outcomes associated with HFNC and conventional oxygen therapy (COT) among patients at high risk for reintubation.
METHODS


A single-center randomized clinical trial was conducted between March 2018 and June 2019. Sixty adults admitted to the ICU and who were at high-risk of reintubation and met the inclusion criteria were enrolled in this study. ""High risk"" for reintubation was defined as having at least one of the following risk factors: age > 65 years, Acute Physiology and Chronic Health Evaluation II score > 12 points on extubation day, obesity, poor expectoration, airway patency problems, difficult or prolonged weaning, and more than one comorbidity. The primary outcome of interest was reintubation within 72 hours. Secondary outcomes included duration of ICU and hospital stay, mortality rate, and time to reintubation.
RESULTS


Of 60 patients, 31 received HFNC and 29 received COT (mean age, 78 ± 7.8 vs. 76 ± 6.5 years, respectively). Reintubation rate within 72 hours did not differ between the groups (3 patients [9.7%] vs. 1 patient [3.4%], respectively). Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant. Duration of ICU did not differ between the groups (14.7 ± 9.6 days vs. 13.8 ± 15.7 days, for HFNC and COT, respectively).
CONCLUSION


Among patients at high risk for reintubation, compared with COT, HFNC did not reduce the risk of reintubation within 72 hours.",2020,"Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant.","['Of 60 patients, 31 received HFNC and 29 received COT (mean age, 78 ± 7.8 vs. 76 ± 6.5 years, respectively', 'patients at high risk for reintubation', 'Patients at High Risk of Reintubation', 'A single-center randomized clinical trial was conducted between March 2018 and June 2019', 'Sixty adults admitted to the ICU and who were at high-risk of reintubation and met the inclusion criteria were enrolled in this study. ']","['COT', 'HFNC and conventional oxygen therapy (COT', 'High-flow nasal cannula (HFNC) oxygen therapy', 'COT, HFNC', 'High-Flow Nasal Cannula vs. Conventional Oxygen Therapy', 'HFNC']","['Reintubation rate', 'duration of an intensive care unit (ICU) stay and mortality rate', 'Extubation success', 'Postextubation Outcomes', 'Reintubation time', 'Duration of ICU', 'duration of ICU and hospital stay, mortality rate, and time to reintubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.17062,"Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant.","[{'ForeName': 'Jun Yeun', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Hee Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Hyeran', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Sun Hyung', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Kang Hyeon', 'Initials': 'KH', 'LastName': 'Choe', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Ki Man', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Yoon Mi', 'Initials': 'YM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea. anees94@hanmail.net.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e194']
1735,32597691,"Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial.","Background:  LC09 is composed with 5 kinds of traditional Chinese herbal medicines ( Astragalus membranaceus , flowers carthami, lithospermum, geranium wilfordii, and radix angelicae) which are used in China and developed over several thousand years.  Aim:  To assess the effectiveness and safety of herbal compound LC09 on patients with capecitabine-associated hand-foot syndrome (HFS).  Materials and Methods:  In this randomized, double-blind, and parallel-controlled study, 156 patients that diagnosed with HFS were randomly assigned to a treatment group (n = 78) or control group (n = 78). Patients were evaluated every week by the National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores. The Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale were used to assess the quality of life before the treatment, and at 1 week and after the treatment of 2 cycles.  Results:  At the baseline, no significant differences were observed between the 2 groups. After treatment, significant differences in NCI grade and NRS pain scores were observed between the 2 groups ( P  < .01). In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P  < .01). Furthermore, the chemotherapy completion rate between 2 groups was significantly different ( P  = .002). In addition, no adverse reactions were observed in either LC09 or control group.  Conclusion:  LC09 can decrease NCI grade and significantly alleviate pain in HFS patients. Besides, it can also increase chemotherapy completion rate.",2020,"In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P  < .01).","['156 patients that diagnosed with HFS', 'Patients With Capecitabine-Associated Hand-Foot Syndrome', 'patients with capecitabine-associated hand-foot syndrome (HFS', 'HFS patients']","['LC09', 'herbal compound LC09', 'Chinese Herbal Compound LC09']","['quality of life', 'NCI grade and NRS pain scores', 'NCI grade', 'National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores', 'HFS effectiveness rate and pain alleviation rate', 'chemotherapy completion rate', 'adverse reactions', 'alleviate pain', 'Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",156.0,0.231078,"In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P  < .01).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Keio University, Tokyo, Japan.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420928466']
1736,32593547,Pegvaliase for the treatment of phenylketonuria: Results of the phase 2 dose-finding studies with long-term follow-up.,"BACKGROUND


Phenylketonuria (PKU) is characterized by a deficiency in phenylalanine hydroxylase (PAH) that may lead to elevated blood phenylalanine (Phe) and significant neurocognitive and neuropsychological comorbidities. Pegvaliase (PALYNZIQ®, BioMarin Pharmaceutical Inc.) is a PEGylated recombinant Anabaena variabilis phenylalanine ammonia lyase (PAL), which converts Phe to trans-cinnamic acid and ammonia, and was approved in May 2018 in the United States and in May 2019 in the European Union for decreasing blood Phe levels in adults with PKU with blood Phe levels >600 μmol/L. The efficacy and safety of pegvaliase was assessed in two phase 2 dose-finding studies in adults with PKU (PAL-002, NCT00925054, and PAL-004, NCT01212744). Participants completing these studies could enroll in a long-term extension study (PAL-003, NCT00924703).
METHODS


Participants in PAL-002 received pegvaliase 0.001, 0.003, 0.01, 0.03, or 0.1 mg/kg weekly for 8 weeks, then continued treatment for a further 8 weeks with dose and/or frequency adjusted to achieve blood Phe concentrations of 60 to 600 μmol/L. Participants in PAL-004 received pegvaliase 0.001 to 0.4 mg/kg 5 days/week for 13 weeks, with modifications made to the starting dose in response to safety and/or efficacy, followed by 3 additional weeks of follow-up assessments. The maximum allowable daily dose in both studies was 1.0 mg/kg/day (5.0 mg/kg/week). Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703).
RESULTS


Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed PAL-004. Mean blood Phe at baseline was 1311.0 (standard deviation [SD] 354) μmol/L in PAL-002 and 1482.1 (SD 363.5) μmol/L in PAL-004. Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13). In PAL-004, mean blood Phe dropped from baseline by 929.1 μmol/L (SD 691.1) by Week 2; subsequent to dose modifications and interruptions, this early decrease in mean Phe level was not sustained. With increased pegvaliase dose and duration in PAL-003, mean blood Phe levels steadily decreased from baseline, with mean reductions by Week 120 of 68.8% (SD 44.2%) in PAL-002 participants and 75.9% (SD 32.4%) in PAL-004 participants. All participants in PAL-002 and PAL-004 reported ≥1 adverse event (AE), with higher exposure-adjusted event rates in PAL-004. The majority of AEs were mild (87.2% in PAL-002, 86.7% in PAL-004) or moderate (12.4% in PAL-002, 13.3% in PAL-004). The most commonly reported AEs in PAL-002 were injection site reaction (50.0% of participants), headache (42.1%), injection site erythema (36.8%), nausea (34.2%), and arthralgia (29.0%), and in PAL-004 were arthralgia (75.0%), headache (62.5%), dizziness (56.3%), injection site erythema (56.3%), and injection site reaction (50.0%).
CONCLUSIONS


In two phase 2 dose-finding studies, pegvaliase did not lead to substantial blood Phe reductions. Higher and more frequent pegvaliase dosing in PAL-004 led to a substantial initial drop in blood Phe, but an increase in the number of hypersensitivity AEs and dose reductions or interruptions. With increased dose and duration of treatment in PAL-003, mean blood Phe reduction was substantial and sustained, and the frequency of hypersensitivity AEs decreased and stabilized. Together, these studies led to the development of an induction-titration-maintenance regimen that has been approved for pegvaliase, with patients starting at a low weekly dose that gradually increases in dose and frequency until they achieve a standard non-weight-based daily maintenance dose. This regimen has been tested in a third phase 2 study, as well as in two successful phase 3 studies of pegvaliase.",2020,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"['Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed', 'adults with PKU with blood Phe levels', 'Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703']",['PAL-004'],"['headache', 'dizziness', 'efficacy and safety of pegvaliase', 'frequency of hypersensitivity AEs', 'mean blood Phe', 'injection site reaction', 'pegvaliase dose and duration in PAL-003, mean blood Phe levels', 'nausea', 'arthralgia', 'injection site erythema', 'adverse event (AE', 'Mean blood Phe']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519229', 'cui_str': 'pegvaliase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.118836,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"[{'ForeName': 'Barbara K', 'Initials': 'BK', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Division of Genetics, Birth Defects & Metabolism, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611, United States of America. Electronic address: BBurton@luriechildrens.org.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Longo', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: Nicola.Longo@hsc.utah.edu.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Department of Pediatrics, Division of Medical Genetics, University of Pittsburgh and Children's Hospital of Pittsburgh, 4401 Penn Ave, Pittsburgh, PA 15224, United States of America. Electronic address: vockleyg@upmc.edu.""}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Grange', 'Affiliation': 'Department of Pediatrics, Division of Genetics and Genomic Medicine, Washington University, 660 S Euclid Ave, St. Louis, MO 63110, United States of America. Electronic address: grangedk@wustl.edu.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health & Science University, Portland, OR 97239, United States of America. Electronic address: hardingc@ohsu.edu.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America.'}, {'ForeName': 'Mingjin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: mili@bmrn.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: klau@bmrn.com.'}, {'ForeName': 'Orli', 'Initials': 'O', 'LastName': 'Rosen', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: orli.rosen@bmrn.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Larimore', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: KLarimore@bmrn.com.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Pediatrics, Section of Clinical Genetics and Metabolism, University of Colorado School of Medicine, 12605 E 16th St, Aurora, CO 80045, United States of America. Electronic address: janet.thomas@childrenscolorado.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.06.006']
1737,32593791,Differential effects of modafinil on performance of low-performing and high-performing individuals during total sleep deprivation.,"BACKGROUND


Individual responses to the effects of inadequate sleep have been well documented; some people are more vulnerable to the effects of sleep loss than others. Fatigue-vulnerable individuals generally require access to effective fatigue countermeasures; however, the question arises as to whether these fatigue-vulnerable individuals receive the same benefits shown in group efficacy data. The present study administered modafinil to individuals to determine its differential effects on performance of best and worst performers during sleep deprivation.
METHODS


A sample of 22 men, age 21-40 yrs., was tested on 2 separate occasions during which they were kept awake for 36 h. During one period they received 200 mg modafinil; during the other they received placebo. Participants were tested on a variety of tasks while rested and at 5-hr intervals across the continuous wakefulness period. Performance for each cognitive task and subjective measure of fatigue from the placebo period was used to group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task.
RESULTS


Results indicated that on the MTS task, the HP group performed the same throughout the testing period, regardless of whether they received modafinil or not. However, the LP group significantly improved after receiving modafinil compared to placebo. Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo. Performance on the RDM showed no difference between groups, regardless of drug condition. Groups did not differ after receiving modafinil on subjective fatigue measured by the POMS.
CONCLUSIONS


Depending on the task, HP individuals did not benefit substantially when administered modafinil compared to placebo. However, the LP individuals improved after receiving modafinil compared to placebo.",2020,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","['low-performing and high-performing individuals during total sleep deprivation', 'group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task', 'A sample of 22 men, age 21-40\u202fyrs., was tested on 2 separate occasions during which they were kept awake for 36\u202fh']","['modafinil', '200\u202fmg modafinil', 'placebo']","['subjective fatigue', 'lapses', 'number of lapses']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.090569,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","[{'ForeName': 'J Lynn', 'Initials': 'JL', 'LastName': 'Caldwell', 'Affiliation': 'Naval Medical Research Unit Dayton, United States of America. Electronic address: jo.caldwell@us.af.mil.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Schroeder', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kunkle', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Stephenson', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172968']
1738,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1739,32593918,Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.,"INTRODUCTION


Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation.
MATERIALS AND METHODS


The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here.
RESULTS


119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
CONCLUSION


Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.",2020,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","['lung cancer patients', 'patients with operable lung cancer', '119 patients']","['postoperative rehabilitation', 'early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group']","['quality of life', 'Health Related Quality of Life (HRQoL', 'HRQoL']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}]","[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",119.0,0.0636671,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.
","[{'ForeName': 'Maja Schick', 'Initials': 'MS', 'LastName': 'Sommer', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark. Electronic address: mss@kraeftcenter-kbh.dk.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Vibe-Petersen', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Maja Bohlbro', 'Initials': 'MB', 'LastName': 'Stærkind', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Klaus Richter', 'Initials': 'KR', 'LastName': 'Larsen', 'Affiliation': 'Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Trier', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Clementsen', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark; Copenhagen Academy for Medical Education and Simulation, University of Copenhagen and the Capital Region of Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Faculty of Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.023']
1740,32593936,Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial.,"OBJECTIVE


Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls.
STUDY DESIGN


This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391.
RESULTS


Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65-2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73-3.17)), and live birth rates (OR 1.69, 95 % CI (0.78-3.64)) per randomised woman between the ESI and the control group.
CONCLUSION


We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.",2020,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"['In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis', 'Endometrial scratch injury with office hysteroscopy before IVF/ICSI', 'subfertile women receiving ESI before IVF treatment in comparison to controls', 'Women in ART treatment', 'participants, investigators or health care personnel']","['office hysteroscopy with ESI (ESI group) or no intervention (control group', 'ESI']","['positive reproductive outcomes', 'live birth rates', 'ongoing pregnancy and live birth rate', 'ongoing pregnancy', 'positive s-hCG', 'pregnancy and live birth rates', 'positive serum hCG (s-hCG']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]",184.0,0.498981,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"[{'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark. Electronic address: sine.berntsen.01@regionh.dk.'}, {'ForeName': 'Kristine Juul', 'Initials': 'KJ', 'LastName': 'Hare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Palmø', 'Affiliation': 'Department of Obstetrics and Gynaecology, Holbaek Hospital, Smedelundsgade 60, 4300 Holbaek, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.034']
1741,32595205,Clinical Efficacy of Combined Hysteroscopic and Laparoscopic Surgery and Reversible Ligation of the Uterine Artery for Excision and Repair of Uterine Scar in Patients with Type II and III Cesarean Scar Pregnancy.,"BACKGROUND With the changes in China's family planning policy, the incidence of cesarean scar pregnancy (CSP) significantly increased in recent years. The present study aimed to investigate the clinical efficacy of combined hysteroscopic and laparoscopic surgery and reversible ligation of the uterine artery for cesarean scar excision and repair in patients with type II and III CSP. MATERIAL AND METHODS This was a retrospective study of 173 patients with type II and III CSP. They were assigned to the hysteroscopy and laparoscopy group (group A), hysteroscopy group (group B), and curettage group (group C) according to the surgery they underwent. The surgical indicators (intraoperative bleeding volume and hospital stay), postoperative recovery (time of serum ß-hCG returning to the normal, postoperative residual lesion, the thickness of the uterine scar, and recovery time of menstruation), and the postoperative complications were compared among the 3 groups. RESULTS In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05). CONCLUSIONS For patients with type II and III CSP, hysteroscopy and laparoscopy surgery and reversible ligation of the uterine artery achieved better clinical outcomes than hysteroscopy or curettage with respect to postoperative recovery. This could be suitable for patients with CSP and desire for fertility.",2020,"In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05).","['patients with type II and III CSP', 'patients with CSP and desire for fertility', '173 patients with type II and III CSP', 'Patients with Type II and III Cesarean Scar Pregnancy']","['Combined Hysteroscopic and Laparoscopic Surgery and Reversible Ligation of the Uterine Artery for Excision and Repair of Uterine Scar', 'hysteroscopy and laparoscopy', 'hysteroscopy group', 'combined hysteroscopic and laparoscopic surgery and reversible ligation of the uterine artery for cesarean scar excision and repair']","['cesarean scar pregnancy (CSP', 'time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation', 'intraoperative bleeding volume and postoperative hospital stay', 'surgical indicators (intraoperative bleeding volume and hospital stay), postoperative recovery (time of serum ß-hCG returning to the normal, postoperative residual lesion, the thickness of the uterine scar, and recovery time of menstruation), and the postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0852828', 'cui_str': 'Excision of scar'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",173.0,0.0289059,"In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}, {'ForeName': 'Lingjun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}, {'ForeName': 'Huiwei', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924076']
1742,32601011,The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing.,"BACKGROUND


Various non-pharmacologic methods are used to alleviate pain in preterm infants who spend their first days in neonatal intensive care units (NICU) because they are exposed to numerous painful interventions.
OBJECTIVE


To determine the effects of Yakson and Gentle Human Touch (GHT) methods on pain and physiologic parameters during heel lancing procedures in preterm infants.
DESIGN AND METHODS


This was a randomised controlled trial. The study was conducted in a NICU between June 2018 and June 2019. A total of 90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group. All preterm infants were randomly divided into groups. Pain responses were evaluated using the Neonatal Infant Pain Scale.
RESULTS


It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
PRACTICAL IMPLICATIONS


Yakson and GHT applied to preterm infants during heel lancing has positive effects on pain and physiologic parameters.",2020,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
","['NICU between June 2018 and June 2019', 'All preterm infants', '90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group', 'preterm infants during heel lancing', 'preterm infants', 'preterm infants who spend their first days in neonatal intensive care units (NICU']","['Yakson and Gentle Human Touch (GHT) methods', 'Yakson and Gentle Human Touch methods']","['Neonatal Infant Pain Scale', 'pain scores and heart rates', 'pain and physiological parameters', 'pain and physiologic parameters', 'Pain responses']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",90.0,0.0465262,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
","[{'ForeName': 'Şadiye', 'Initials': 'Ş', 'LastName': 'Dur', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Bahçeşehir University, Istanbul, Turkey.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Çağlar', 'Affiliation': 'Pediatric Nursing Department, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpaşa, Istanbul, Turkey. Electronic address: sedac@istanbul.edu.tr.'}, {'ForeName': 'Nagehan Ustabaş', 'Initials': 'NU', 'LastName': 'Yıldız', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Doğan', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'İpek Güney', 'Initials': 'İG', 'LastName': 'Varal', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102886']
1743,32618572,Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial.,"BACKGROUND


Even though 1 in 5 Americans experience some form of mental illness each year, 80% have been shown to discontinue psychotherapy prematurely. The traditional psychotherapy service delivery model, consisting of isolated clinical sessions, lacks the ability to keep patients engaged outside clinical sessions. Newer digital mental health platforms can address the clinical need for a robust tool that tracks mental well-being and improves engagement in patients with depressive symptoms.
OBJECTIVE


The primary goals of this feasibility study were to (1) assess compliance among providers and their patients with a digital mental health platform protocol, and (2) examine the usability and fidelity of a mobile app through structured participant feedback.
METHODS


A sample of 30 participants was recruited for a 5-week study from a community-based mental health clinic in Baltimore, Maryland, USA. Inclusion criteria were: aged 18 years or older, having access to a smartphone, and having at least mild-to-moderate depression and/or anxiety as measured by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales, respectively. Eligible participants were randomized into one of two study arms: (1) the intervention arm or (2) the waitlist control arm. Participants in the intervention arm were asked to download the Rose app and were prompted to complete clinical assessments (PHQ-9 and GAD-7) every other week, daily mood and anxiety Likert scales, and daily journal entries. The participants in the waitlist arm served as controls for the study and completed the clinical assessments only. Both arms engaged in weekly psychotherapy sessions, with participant in-app input informing the psychotherapy process of the intervention arm, while those in the waitlist control arm continued their standard care. Outcomes of interest included adherence to completion of in-app assessments and usability of the Rose mobile app assessed through the modified Mobile Application Rating Scale.
RESULTS


Over the study period, a sample of 30 participants used the Rose app 2834 times to complete clinical assessments. On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week. Nearly all participants (29/30, 97%) completed all PHQ-9 and GAD-7 in-app scales during the study. Subjective impressions showed that 73% (22/30) of participants found the mobile app to be engaging and in line with their needs, and approximately 70% (21/30) of participants reported the app functionality and quality of information to be excellent. Additionally, more than two-thirds of the participants felt that their knowledge and awareness of depression and anxiety management improved through using the app.
CONCLUSIONS


Steady compliance and high app ratings showcase the utility of the Rose mobile mental health app in augmenting the psychotherapy process for patients with mood disorders and improving mental health knowledge. Future studies are needed to further examine the impact of Rose on treatment outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04200170; https://clinicaltrials.gov/ct2/show/NCT04200170.",2020,"On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week.","['patients with depressive symptoms', 'Eligible participants', 'Inclusion criteria were: aged 18 years or older, having access to a smartphone, and having at least mild-to-moderate depression and/or anxiety as measured by the', 'A sample of 30 participants was recruited for a 5-week study from a community-based mental health clinic in Baltimore, Maryland, USA', 'patients with mood disorders and improving mental health knowledge']",['Mobile App to Augment Psychotherapy'],"['knowledge and awareness of depression and anxiety management', 'PHQ-9 and GAD-7', 'Subjective impressions', 'Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales', 'modified Mobile Application Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]",30.0,0.108425,"On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week.","[{'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Adam', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Key Point Health Services, Inc, Baltimore, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pletnikova', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Bagga', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vita', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'N Richey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Munshaw', 'Affiliation': 'Carey Business School, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Kavi', 'Initials': 'K', 'LastName': 'Misrilall', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Peters', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}]",JMIR formative research,['10.2196/17722']
1744,32618578,Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial.,"BACKGROUND


Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control.
OBJECTIVE


This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA.
METHODS


This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index.
RESULTS


We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes.
CONCLUSIONS


A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323.",2020,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"['enrolled 51 participants (IG: n=26 and DG: n=25', 'people with knee OA', 'patients with knee OA', 'People With Knee Osteoarthritis']","['12-Week Multifaceted Wearable-Based Program', 'PT counseling', 'physiotherapist (PT)-led counseling intervention', 'multifaceted wearable-based program']","['daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index', 'perceived sitting habit', 'physical activity', 'MVPA', 'MVPA time', 'time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini']","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",51.0,0.150513,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"[{'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Feehan', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Shaw', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gromala', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Aviña-Zubieta', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hoens', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Koehn', 'Affiliation': 'Arthritis Consumer Experts, Vancouver, BC, Canada.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Tam', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Therrien', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Townsend', 'Affiliation': 'Division of Health Research, Faculty of Health & Medicine, Lancaster University, Lancashire, United Kingdom.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Noonan', 'Affiliation': 'Mary Pack Arthritis Program, Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Backman', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/19116']
1745,32618695,Acute Kidney Injury in Acute Ischemic Stroke Patients in Clinical Trials.,"OBJECTIVES


Acute ischemic stroke patients are at risk of acute kidney injury due to volume depletion, contrast exposure, and preexisting comorbid diseases. We determined the occurrence rate and identified predictors associated with acute kidney injury in acute ischemic stroke patients.
SETTING


Multiple specialized ICUs within academic medical centers.
DESIGN


Post hoc analysis of pooled data from prospective randomized clinical trials.
PATIENTS


Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset.
INTERVENTIONS


IV recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo.
MEASUREMENTS AND MAIN RESULTS


Serum creatinine levels from baseline and within day 5 or discharge were used to classify acute kidney injury classification into stages. Any increase in serum creatinine was seen in 697 (36.1%) and acute kidney injury was seen in 68 (3.5%) of 1,931 patients with acute ischemic stroke. Severity of acute kidney injury was grade I, II, and III in 3.1%, 0.4%, and 0.05% patients, respectively. Patients with albumin (5.5% compared with 2.6%; p = 0.001), preexisting hypertension (4.3% compared with 1.5%; p = 0.0041), and preexisting renal disease (9.1% compared with 3.0%; p < 0.0001) had higher risk of acute kidney injury. The risk of acute kidney injury was lower between those who either underwent CT angiography (2.0% compared with 4.7%; p = 0.0017) or endovascular treatment (1.6% compared with 4.2%; p = 0.0071). In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury. The risk of death was significantly higher among patients with acute kidney injury (odds ratio, 2.7; 95% CI, 1.4-4.9) after adjusting for age and National Institutes of Health Stroke Scale score strata.
CONCLUSIONS


The occurrence rate of acute kidney injury in acute ischemic stroke patients was low and was not higher in patients who underwent CT angiogram or those who received endovascular treatment. Occurrence of acute kidney injury increased the risk of death within 3 months among acute ischemic stroke patients.",2020,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","['1,931 patients with acute ischemic stroke', 'Multiple specialized ICUs within academic medical centers', 'Acute Ischemic Stroke Patients', 'acute ischemic stroke patients', 'Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset', 'Acute ischemic stroke patients']","['CT angiography', 'recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo', 'CT angiogram']","['preexisting renal disease', 'risk of death', 'serum creatinine', 'renal disease', 'Serum creatinine levels', 'acute kidney injury', 'preexisting hypertension', 'risk of acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1931.0,0.150194,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': '1Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN. 2Department of Neurology, University of Missouri, Columbia, MO. 3Department of Medicine, University of Missouri, Columbia, MO. 4Division of Neurosurgery, Department of Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Hunain', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': ''}, {'ForeName': 'Werdah', 'Initials': 'W', 'LastName': 'Zafar', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': ''}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Naqvi', 'Affiliation': ''}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': ''}, {'ForeName': 'Premkumar N', 'Initials': 'PN', 'LastName': 'Chandrasekaran', 'Affiliation': ''}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': ''}, {'ForeName': 'Brandi R', 'Initials': 'BR', 'LastName': 'French', 'Affiliation': ''}, {'ForeName': 'Camilo R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004464']
1746,32618838,Is Noninvasive Vagus Nerve Stimulation a Safe and Effective Alternative to Medication for Acute Migraine Control?,"BACKGROUND


Noninvasive neuromodulation devices have been used for a variety of headache disorders, including cluster and migraine, since recently being cleared by the Federal Drug Administration. Although these devices have been touted as low-risk options for improved headache control, the data behind actual efficacy endpoints remain unclear.
OBJECTIVE


To critically assess current evidence regarding the efficacy of the noninvasive vagus nerve stimulator (nVNS) device for acute migraine management.
METHODS


The objective was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom line conclusions.Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache.
RESULTS


A randomized, double-blind, sham-controlled clinical trial was selected for critical appraisal. In this trial, the primary endpoint (pain freedom at 120 min after use of nVNS for first acute migraine attack) was not met when compared with sham device (30.4% for nVNS vs. 19.7% for sham; P=0.067). However, there were statistically significant differences found for various secondary endpoints favoring nVNS, such as pain freedom rates at 30 and 60 minutes, pain relief at 120 minutes, and mean percentage pain score reduction rates at 60 and 120 minutes.
CONCLUSIONS


When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis. nVNS is likely a safe alternative to medications.",2020,"When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis.","['Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache']","['nVNS', 'noninvasive vagus nerve stimulator (nVNS) device']","['primary endpoint (pain freedom', 'pain freedom rates', 'pain freedom', 'pain relief', 'mean percentage pain score reduction rates']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0079695', 'cui_str': 'Librarian'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1516908', 'cui_str': 'Epidemiologist'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C2959478', 'cui_str': 'Vagal nerve stimulator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.239962,"When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis.","[{'ForeName': 'Benzion', 'Initials': 'B', 'LastName': 'Blech', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Amaal J', 'Initials': 'AJ', 'LastName': 'Starling', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marks', 'Affiliation': 'Library Services, Mayo Clinic, Scottsdale/Phoenix, AZ.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Cumara B', 'Initials': 'CB', 'LastName': ""O'Carroll"", 'Affiliation': 'Departments of Neurology.'}]",The neurologist,['10.1097/NRL.0000000000000274']
1747,32619609,"Evaluating the structural effects of intra-articular sprifermin on cartilage and non-cartilaginous tissue alterations, based on sqMRI assessment over 2 years.","OBJECTIVE


Sprifermin (recombinant human fibroblast growth factor-18), a potential disease-modifying osteoarthritis (OA) drug, demonstrated dose-dependent effects on femorotibial cartilage thickness (by quantitative magnetic resonance imaging [MRI]) in the phase II FORWARD study. This post-hoc analysis evaluated the potential effects of sprifermin on several articular structures in the whole joint over 24 months using semi-quantitative MRI assessment.
DESIGN


Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee were randomized (1:1:1:1:1) to receive three double-blinded, once-weekly, intra-articular injections of sprifermin 30 μg or 100 μg or placebo every 6 (q6mo) or 12 months. 1.5- or 3 T MRIs were read using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system at baseline and 24 months. Change from baseline at 24 months on compartment and/or whole knee level was assessed for cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches. Menisci, Hoffa-synovitis, and effusion-synovitis were also evaluated for worsening.
RESULTS


549 patients were included. Dose-dependent treatment effects from baseline to 24 months were observed on cartilage morphology (sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.6 (-1.5, 0.2); less cartilage worsening) in the entire knee and BMLs sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.2 (-0.5, 0.1) in the patellofemoral compartment. No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
CONCLUSIONS


Positive effects associated with sprifermin were observed for cartilage morphology changes, and BML improvement. There were no meaningful negative or positive effects associated with sprifermin in the other joint tissues examined.",2020,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","['549 patients were included', 'Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee']","['Sprifermin (recombinant human fibroblast growth factor-18', 'sprifermin 30 μg or 100 μg or placebo', 'placebo']","['Menisci, Hoffa-synovitis, and effusion-synovitis', 'cartilage morphology', 'osteophytes, menisci, Hoffa-synovitis or effusion-synovitis', 'cartilage morphology changes, and BML improvement', 'femorotibial cartilage thickness', 'cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C1432638', 'cui_str': 'fibroblast growth factor 18, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0268203', 'cui_str': 'Liposynovitis prepatellaris'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",549.0,0.160466,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis.
","[{'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; University of Erlangen-Nuremberg, Erlangen, Germany. Electronic address: froemer@bu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kraines', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA; A Business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA; A Business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wax', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA; A Business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Crema', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Institute of Sports Imaging, French National Institute of Sports, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA; Department of Radiology, VA Boston Healthcare System, West Roxbury, MA, 02132, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.05.015']
1748,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1749,32620104,"A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression.","BACKGROUND


Depression has rapidly progressed worldwide, and the need for an efficient treatment with low side effect has risen. Melissa officinalis L and Lavandula angustifolia Mill have been traditionally used in Asia for the treatment of depression. Many textbooks of traditional Persian medicine refer to these herbs for the treatment of depression while there are no adequate clinical trials to support this claim. The present study aimed to evaluate the efficacy of M. officinalis and L. angustifolia compared to fluoxetine for the treatment of mild to moderate depression in an 8-week randomized, double-blind clinical trial.
METHODS


Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression, were randomly assigned to 3 groups to daily receive either M. officinalis (2 g) or L. angustifolia (2 g) or fluoxetine (20 mg) and were assessed in weeks 0, 2, 4 and 8 by the Hamilton Rating Scale for Depression (HAM-D) including 17 items.
RESULTS


Our study showed that M. officinalis and L. angustifolia effect similar to fluoxetine in mild to moderate depression. (F = 0.131, df = 2,42, p = 0.877).
CONCLUSION


Due to some restrictions in this study including absence of placebo group, large-scale trials are needed to investigate the anti-depressant effect of these two herbs with more details.
TRIAL REGISTRATION


IRCT2014061718126N1 . Registration date: 2015-06-04-""Retrospectively registered"".",2020,"(F = 0.131, df = 2,42, p = 0.877).
","['Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression', 'mild to moderate depression']","['fluoxetine', 'Melissa officinalis L and Lavandula angustifolia', 'M. officinalis (2\u2009g) or L. angustifolia (2\u2009g) or fluoxetine', 'Melissa officinalis L. and Lavandula angustifolia Mill', 'Fluoxetine', 'placebo']",[],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1008143', 'cui_str': 'Lemon Balm'}, {'cui': 'C1623196', 'cui_str': 'Lavandula angustifolia'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],45.0,0.0615834,"(F = 0.131, df = 2,42, p = 0.877).
","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Araj-Khodaei', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Ahmad Ali', 'Initials': 'AA', 'LastName': 'Noorbala', 'Affiliation': 'Psychosomatic Medicine Research center, Psychosomatic Ward, Imam Khomeini Hospital, Tehran University of Medical Sciences, End of Keshavarz Blv, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yarani', 'Affiliation': 'Department of Pediatrics E, Copenhagen Diabetes Research Center (CPH-DIRECT), Herlev University Hospital, Herlev, 2730, Copenhagen, Denmark.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Emadi', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Emaratkar', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Department of Biostatistic and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Mahdavi St., Karmandan Town, Zanjan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Parsian', 'Affiliation': 'Emergency Medicine Research Team, Daneshgah St. Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alijaniha', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran. naseri@shahed.ac.ir.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03003-5']
1750,32620116,Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country.,"BACKGROUND


Older patients with multimorbidity have complex health and social care needs, associated with elevated use of health care resources. The aim of this study is to evaluate the impact of CareWell integrated care model for older patients with multimorbidity in the Basque Country.
METHODS


The CareWell program for older patients with multimorbidity, based on the coordination between health providers, home-based care and patient empowerment, supported by information and communication technology tools. The program was deployed in four healthcare areas in the Basque Country. The control group was formed by two organizations in which the program had not been deployed and regular care procedures were applied. Participants, older patients (aged ≥65) with two or more chronic conditions (at least one being chronic obstructive pulmonary disease, chronic heart failure, or diabetes mellitus), categorized as complex according to a risk stratification algorithm, were followed up to 12 months. The impact of the program on the use of health resources, clinical effectiveness, and satisfaction was evaluated using a mixed-method approach. Semi-structured interviews were performed to assess satisfaction with the newly deployed model and mixed regression models to measure the effect of the intervention throughout the follow-up period.
RESULTS


Two hundred patients were recruited (101 intervention and 99 control), mostly males (63%) with a mean age of 79 years and age-adjusted Charlson Comorbidity Index of 9.7 on average. Relevant differences between the groups were observed for all dimensions. In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased. Clinical changes were also observed, such as a decrease in the body mass index and blood glucose levels. The satisfaction level was high for all stakeholders.
CONCLUSION


The implementation of CareWell integrated care model changed the profile of health resource utilization, strengthening the key role of primary care and reducing the number of emergency visits and hospitalizations. The satisfaction with this model of care was high.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03042039 . Registered 3 February 2017 - Retrospectively registered.",2020,"In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased.","['Two hundred patients were recruited (101 intervention and 99 control), mostly males (63%) with a mean age of 79\u2009years and age-adjusted Charlson Comorbidity Index of 9.7 on average', 'Older patients with multimorbidity', 'Registered 3 February 2017', 'older patients with multimorbidity in the Basque Country', 'Participants, older patients (aged ≥65) with two or more chronic conditions (at least one being chronic obstructive pulmonary disease, chronic heart failure, or diabetes mellitus', 'older patients with multimorbidity']",['CareWell integrated care model'],"['body mass index and blood glucose levels', 'satisfaction level', 'number of hospitalizations and visits to emergency centers']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0337796', 'cui_str': 'Basques'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",200.0,0.0243765,"In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased.","[{'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateo-Abad', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain. maider.mateoabad@osakidetza.eus.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'González', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Fullaondo', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Merino', 'Affiliation': 'Osakidetza Basque Health Service, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, Spain.'}, {'ForeName': 'Lierni', 'Initials': 'L', 'LastName': 'Azkargorta', 'Affiliation': 'Osakidetza Basque Health Service, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giné', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Verdoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'de Manuel Keenoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}]",BMC health services research,['10.1186/s12913-020-05473-2']
1751,32597889,[Use of Detravenol in treatment of chronic venous insufficiency of lower limbs].,"AIM


The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins.
PATIENTS AND METHODS


Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily. The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning.
RESULTS


The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
CONCLUSION


By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.",2020,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
","['patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins', 'patients with chronic venous insufficiency of the lower limbs', '106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins', 'chronic venous insufficiency of lower limbs']","['Detralex®', 'Detravenol']","['efficacy (reduction of the malleolar circumference) therapy', 'Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning', 'efficacy and safety', 'malleolar circumference upon completion of treatment', 'oedema of the lower extremities: the malleolar circumference', 'efficacy', 'composite index of the venous clinical severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0379896', 'cui_str': 'Detralex'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",106.0,0.038315,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
","[{'ForeName': 'É A', 'Initials': 'ÉA', 'LastName': 'Ponomarev', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Strepetov', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Sotnikov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': ""Vasil'ev"", 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Arnautov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Kasatkina', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bukhtenkov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGI02020201']
1752,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077']
1753,32593750,Effect of acute caffeine intake on hit accuracy and reaction time in professional e-sports players.,"Caffeine is considered a cognitive enhancer at low to moderate doses because it improves alertness, vigilance, attention, and reaction time. However, no previous investigation has assessed the effect of acute caffeine intake on e-sports-specific performance. The aim of this investigation was to determine the effect of the ingestion of 3 mg per kg of body mass on simple reaction time in a color test and on hit accuracy and reaction time during a first-person shooting game. Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial. In two trials 3 days apart, participants either ingested a placebo (cellulose) or 3 mg/kg of caffeine in an opaque and unidentifiable capsule. After a 45-min wait for substance absorption, participants performed 5 attempts at a simple reaction time test and completed a first-person shooting game that included 3 attempts at a 2-min game with 60 fixed targets (180 targets in total). Reaction times (in both tests) and accuracy in hitting the targets (only in the shooting game) were measured. In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01). In summary, the acute ingestion of 3 mg/kg of caffeine reduced the time taken to react to a simple stimulus, decreased the time taken to hit a fixed target and improved accuracy in hitting the target in a first-person shooting game in professional e-gamers. Thus, the caffeine ingestion (3 mg/kg) might be considered as an ergogenic aid for e-sports gamers based on its effect to enhance hit accuracy and time.",2020,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","['Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial', 'professional e-sports players']","['acute caffeine intake', 'caffeine ingestion', 'caffeine', 'placebo (cellulose) or 3 mg/kg of caffeine', 'Caffeine', 'placebo, caffeine']","['enhanced hit accuracy', 'time taken to hit a fixed target and improved accuracy', 'alertness, vigilance, attention, and reaction time', 'simple reaction time', 'Reaction times', 'hit accuracy and reaction time', 'mean time taken to hit the targets']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0879569,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sainz', 'Affiliation': 'Team Queso, e-Gamers Club. Madrid, Spain. Electronic address: nachosainz10@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: daniel.collado@urjc.es.'}, {'ForeName': 'Juan Del', 'Initials': 'JD', 'LastName': 'Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: juan.delcoso@urjc.es.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113031']
1754,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND


Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported.
OBJECTIVES


To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors.
METHODS


Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used.
RESULTS


Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001).
CONCLUSIONS


Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Ziliotto', 'Initials': 'Z', 'LastName': 'Nicole', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.'}, {'ForeName': 'Lamberti', 'Initials': 'L', 'LastName': 'Nicola', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Manfredini', 'Initials': 'M', 'LastName': 'Fabio', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Straudi', 'Initials': 'S', 'LastName': 'Sofia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Baroni', 'Initials': 'B', 'LastName': 'Marcello', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Tisato', 'Initials': 'T', 'LastName': 'Veronica', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carantoni', 'Initials': 'C', 'LastName': 'Matteo', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Secchiero', 'Initials': 'S', 'LastName': 'Paola', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Basaglia', 'Initials': 'B', 'LastName': 'Nino', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marchetti', 'Initials': 'M', 'LastName': 'Giovanna', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Bernardi', 'Initials': 'B', 'LastName': 'Francesco', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319']
1755,32594785,"Influence of timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine on oxidative stress biomarkers in the tear film.","PURPOSE


The objective of this study was to investigate the influence of topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine on total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI) in the tear film.
METHODS


The patients were divided into four groups: group C ( n  = 25)-control group-subjects who did not use topical antiglaucoma medications, group T ( n  = 17)-patients using topical preservative-free timolol, group T + BAC ( n  = 24)-patients using topical BAC-preserved timolol, and group BR + BAC ( n  = 19)-patients using topical BAC-preserved brimonidine.
RESULTS


The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.
CONCLUSIONS


This indicates that using BAC-preserved topical medications increases oxidative stress in the tear film and may, in the long-term, contribute to the clinical presentation of dry eye disease.",2020,"Results:  The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.",[],"['preservative-free timolol', 'BAC-preserved topical medications', '25)-control group-subjects who did not use topical antiglaucoma medications, group T (n\u2009=\u200917)-patients using topical preservative-free timolol, group T\u2009+\u2009BAC (n\u2009=\u200924)-patients using topical BAC-preserved timolol, and group BR\u2009+\u2009BAC (n\u2009=\u200919)-patients using topical BAC-preserved brimonidine', 'brimonidine', 'timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine', 'topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine']","['SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI', 'total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI', 'oxidative stress', 'oxidative stress biomarkers']",[],"[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0005025', 'cui_str': 'Benzalkonium'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium chloride'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0166171,"Results:  The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.","[{'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Sedlak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Wojnar', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zych', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Wyględowska-Promieńska', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Katowice, Poland.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1787435']
1756,32601796,"Safety and efficacy of temsirolimus in combination with three different immuno-chemotherapy regimens in relapse and refractory mantle cell lymphoma, final results of the T 3  phase IB trial of the LYSA.","Mantle cell lymphoma has a dismal prognosis at relapse or in the refractory setting. Among therapies, mTor pathway targeting by temsirolimus has been the first strategy approved for relapse in Europe. While its efficacy in monotherapy has long been demonstrated, its use remains limited. In the T 3  phase Ib clinical trial, we investigated the recommended dose of temsirolimus in association with R-CHOP (R-CHOP-T), or high-dose cytarabine plus rituximab (R-DHA-T), or fludarabine, cyclophosphamide plus rituximab (R-FC-T). From November 11, 2011 to February 26, 2015, forty-one patients were enrolled. Patients presented with high MIPI (47.5%) at relapse and a median number of treatments of 1 (1-3). Patients were treated by R-CHOP-T (n = 10), R-FC-T (n = 14), or R-DHA-T (n = 17) according to the choice of local investigators. The maximum tolerated dose (MTD) was 15 mg in the R-CHOP-T arm and has not been determined in other treatment arms because of toxicities. All patients experienced ≥ Grade 3 adverse events, mainly thrombocytopenia (76%). Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8). Of note, 6 patients of the R-DHA-T arm reached complete remission (35%). Temsirolimus with immuno-chemotherapy is associated with a high rate of toxicities. Determination of MTD could only be achieved for R-CHOP-T arm. Associations between temsirolimus and other targeted therapies may be warranted for R/R MCL patients.",2020,"Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8).","['Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n\u2009=\u200912) and progression of the disease (n\u2009=\u20098', 'From November 11, 2011 to February 26, 2015, forty-one patients were enrolled']","['temsirolimus', 'cytarabine plus rituximab (R-DHA-T), or fludarabine, cyclophosphamide plus rituximab', 'Temsirolimus with immuno-chemotherapy']","['complete remission', 'Safety and efficacy', '≥ Grade 3 adverse events, mainly thrombocytopenia', 'maximum tolerated dose (MTD']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0278348', 'cui_str': 'Immunotherapy for cancer'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}]",41.0,0.0540781,"Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8).","[{'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tessoulin', 'Affiliation': 'Department of Hematology, CHU de Nantes, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Haematology, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burroni', 'Affiliation': 'Pathology Department, Cochin University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': 'INSERM U917, CHU Pontchaillou, Rennes, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Gressin', 'Affiliation': 'Hematology, CHU Grenoble, Grenoble, Grenoble, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'Department of clinical hematology, University Hospital Montpellier, Montpellier, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Clémentine', 'Initials': 'C', 'LastName': 'Sarkozy', 'Affiliation': 'Hematology, Hospices Civils de Lyon, Pierre Bénite, Lyon, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': 'Lymphoid Malignancies Unit, AP-HP, Groupe Hospitalier Mondor, Croéteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Hematology Department, Hopital Le Bocage, CHU Dijon, Dijon, France.'}, {'ForeName': 'Clementine', 'Initials': 'C', 'LastName': 'Joubert', 'Affiliation': 'Department of Biostatistics, LYSARC, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gyan', 'Affiliation': ""Service d'Hématologie et thérapie cellulaire, Centre Hospitalier Universitaire, Tours, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Hematology Department, Necker University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Department of Hematology, CHU de Nantes, University Hospital of Nantes, Nantes, France. steven.legouill@chu-nantes.fr.'}]",Annals of hematology,['10.1007/s00277-020-04159-3']
1757,32598387,Bleeding profile of women using a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.,"BACKGROUND


Progestin-only pills are associated with irregular bleeding pattern including amenorrhea. Desogestrel 75mcg even being a pill that inhibits ovulation shows a poor cycle control that limits a more common use. A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.
METHODS


A phase III study in healthy women aged 18 to 45 years was performed to compare the bleeding profile and safety of women taking a DRSP only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over 9 cycles. A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed. The primary endpoint was the proportion of women with bleeding/spotting days in each cycle from cycles 2 to 9 and cumulative in cycles 2 to 4 and cycles 7 to 9 including and excluding those with amenorrhea.
FINDINGS


In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding including those which did not bleed was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of unscheduled bleeding and spotting days during cycles 2-9 was statistically significantly lower in the DRSP group than in the DSG group (21.5 [22.86] days vs. 34.7 [33.73] days, p = 0.0003, Wilcoxon-rank-sum-test). Excluding amenorrhoeic women following results were obtained: In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of bleeding days was 8.6 [8.52] days vs. 12.9 [16.47] days, p = 0.0233.
CONCLUSIONS


This report describes the improvement in bleeding profile of women using the new DRSP only oral contraceptive in comparison to DSG providing a better quality of live and adherence to the contraceptive method. EudraCT registration number: 2011-002396-42.",2020,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","['858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed', 'healthy women aged 18 to 45 years', 'Excluding amenorrhoeic women following results were obtained']","['DRSP', 'placebo versus desogestrel', 'drospirenone (DRSP)-only pill', 'drospirenone', 'DRSP tablets', 'Desogestrel']","['mean [SD] number of bleeding days', 'proportion of women with unscheduled bleeding', 'bleeding profile and safety', 'quality of live and adherence', 'bleeding profile', 'proportion of women with bleeding/spotting days', 'proportion of women with unscheduled bleeding including those which did not bleed', 'mean [SD] number of unscheduled bleeding and spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]",858.0,0.0815399,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Salud y Medicina de la Mujer, Director-Instituto Palacios, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]",PloS one,['10.1371/journal.pone.0231856']
1758,32598397,Profiling the health-related physical fitness of Irish adolescents: A school-level sociodemographic divide.,"BACKGROUND AND AIMS


Examining factors that may explain disparities in fitness levels among youth is a critical step in youth fitness promotion. The purpose of this study was twofold; 1) to examine the influence of school-level characteristics on fitness test performance; 2) to compare Irish adolescents' physical fitness to European norms.
METHODS


Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness. Tests included: body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR).
RESULTS


Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction). Participants in designated disadvantaged schools had significantly higher body mass index levels (p < 0.001), and significantly lower cardiorespiratory endurance (20 m SRT) (p < 0.001) and muscular strength (handgrip strength) (p = 0.018) levels compared to participants in non-disadvantaged schools. When compared to European norms, girls in this study scored significantly higher in the 20 m SRT, 4 x 10 metre shuttle run and SBJ tests, while boys scored significantly higher in the BSR test (Cohen's d 0.2 to 0.6, p < 0.001). However, European adolescents had significantly higher handgrip strength scores (Cohen's d 0.6 to 0.8, p < 0.001).
CONCLUSION


Irish adolescents compared favourably to European normative values across most components of HRPF, with the exception of muscular strength. School socioeconomic status was a strong determinant of performance among Irish adolescents. The contrasting findings for different fitness components reiterate the need for multi-component testing batteries for monitoring fitness in youth.",2020,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[""Irish adolescents' physical fitness to European norms"", 'Irish adolescents', 'Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness']",[],"['handgrip strength scores', 'muscular strength (handgrip strength', 'cardiorespiratory endurance', 'body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR', 'body mass index levels', 'BSR test']","[{'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1215.0,0.0397272,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[{'ForeName': 'Brendan T', 'Initials': 'BT', 'LastName': ""O'Keeffe"", 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'MacDonncha', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}]",PloS one,['10.1371/journal.pone.0235293']
1759,32598941,Unskilled shooters improve both accuracy and grouping shot having as reference skilled shooters cortical area: An EEG and tDCS study.,"Transcranial direct current stimulation (tDCS) has been used as a non-invasive method for enhanced motor and cognitive abilities. However, no previous study has investigated if the tDCS application in unskilled shooters on cortical sites, selected based on the cortical activity of skilled shooters, improves the accuracy and shot grouping. Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters. After we identified the right dorsolateral prefrontal cortex (DLPFC) as the area with the highest activity in skilled shooters, we applied anodal tDCS over the right DLPFC in the unskilled shooters under two conditions: sham-tDCS (placebo) and real-tDCS (anodal tDCS). We also analyzed electroencephalography. Our results indicated that anodal tDCS application enhanced the shot accuracy (p = 0.001). Furthermore, the beta power in the EEG recording was higher in the left DLPFC, left and right parietal cortex (p = 0,001) after applying anodal tDCS, while the low-gamma power was higher in the right DLPFC in sham-tDCS (p = 0.001) and right parietal cortex after anodal-tDCS (p = 0.001). Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC. Furthermore, beta and low-gamma bands are influenced by anodal tDCS over the right DLPFC, which may be predictive of skill improvement.",2020,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"['Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters']","['tDCS (placebo) and real-tDCS (anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'anodal tDCS']",['beta power in the EEG recording'],"[{'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",60.0,0.0141525,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"[{'ForeName': 'Kaline', 'Initials': 'K', 'LastName': 'Rocha', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil. Electronic address: kalinemrocha@gmail.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Magalhães', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Valécia', 'Initials': 'V', 'LastName': 'Carvalho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Crespo', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Biomedical Engineering Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil; Brain Mapping and Functionality Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, United States.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113036']
1760,32600363,"Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19): A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


Primary objective: Evaluation of the effect of the proton pump inhibitor (PPI) pantoprazole on the absorption of hydroxychloroquine (HCQ). Secondary objectives: • Evaluation of the relationship between HCQ concentrations in whole blood, plasma and intracellular concentrations in target cells - peripheral blood mononuclear cells (PBMCs). • Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes).
TRIAL DESIGN


Single centre, open-label, parallel group, two-arm, phase I drug-drug interaction trial.
PARTICIPANTS


Healthy volunteers (18-60 years old) are treated in the Clinical Pharmacological Trial Center of Heidelberg University Hospital, Germany.
INTERVENTION AND COMPARATOR


• Participants are randomized in a group to either receive a nine-day course of pantoprazole, or to a control group without pantoprazole. All participants receive a single dose of HCQ 400 mg. • Additionally, CYP3A4 and CYP2D6 phenotyping with microdosed probe drugs is performed using midazolam and yohimbine as enzyme activity markers, respectively.
MAIN OUTCOMES


Primary endpoint: Area under the curve (AUC) 0-72 h  and maximum concentration (C max ) of a single oral dose of 400 mg HCQ with and without pantoprazole (changes in these two values describe relevant aspects of exposure to HCQ with and without administration of pantoprazole). Secondary endpoints: • AUC 2-4 h , AUC 0-6 h  and C max  of midazolam and yohimbine. • Correlation of HCQ concentrations in whole blood with concentrations in plasma and peripheral blood mononuclear cells (PBMC).
RANDOMISATION


Participants are assigned to treatment groups by using a randomisation list (1:1, block size = 4) and consecutive enrolment.
BLINDING (MASKING)


The trial is an open-label trial, participants and investigators are not blinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total number of 24 participants (12 per group) are planned to be randomised.
TRIAL STATUS


Protocol version 2.1 dated 24/04/2020, first patient first visit. April 30th, 2020, recruitment ongoing, anticipated end of study June 30th, 2020.
TRIAL REGISTRATION


EudraCT Number: 2020-001470-30 , registered on 31 March 2020 German Clinical trials register number / International Clinical Trials Registry Platform: DRKS00021573, registered on 27 April 2020 FULL PROTOCOL: The full trial protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full trial protocol. The trial protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes).
","['2020-001470-30 , registered on 31 March 2020 German Clinical trials register number / International Clinical Trials Registry Platform', 'Healthy volunteers (18-60 years old) are treated in the Clinical Pharmacological Trial Center of Heidelberg University Hospital, Germany', 'Corona Virus Disease-19 (Covid-19', 'registered on 27 April 2020']","['pantoprazole', 'hydroxychloroquine', 'pantoprazole, or to a control group without pantoprazole', 'HCQ', 'midazolam and yohimbine', 'proton pump inhibitor (PPI) pantoprazole']","['plasma and peripheral blood mononuclear cells (PBMC', 'Primary endpoint: Area under the curve (AUC) 0-72 h  and maximum concentration (C max ', 'HCQ concentrations in whole blood, plasma and intracellular concentrations in target cells - peripheral blood mononuclear cells (PBMCs', 'absorption of hydroxychloroquine (HCQ']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0221284', 'cui_str': 'Leptocyte'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.443929,"Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes).
","[{'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Stoll', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany. antje.blank@med.uni-heidelberg.de.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Czock', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Foerster', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hermann', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Häußler', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Muhareb', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Hummler', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}]",Trials,['10.1186/s13063-020-04476-y']
1761,32600378,"Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial.","BACKGROUND


In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China). The WHO declared the situation as a Public Health Emergency of International Concern, and it was finally declared a global pandemic on March 11, 2020. The Spanish Government obliges the entire population to remain confined to their homes, with the exception of essential basic services, to stop the spread of COVID-19. Home isolation implies a notable physical deconditioning. Telerehabilitation methods have reported positive experiences, and we propose to study in affected patients of COVID-19, due to the general house confinement of the entire Spanish population.
METHODS


Patients will be recruited in the regions of Andalusia, Murcia, and Valencia (Spain). Patients will remain confined to their homes, and there, they will carry out their assigned exercise program, which will be controlled telematically. Evaluators will attend to carry out all measurements at the beginning, during, and end of the study, telematically controlled. The patients will be randomly divided into three groups, two of them will perform a home exercise program (breathing exercises or non-specific exercises for muscle toning) and the third group will perform sedentary activities, using mental activation techniques, and will act as a sham group. We will evaluate respiratory variables and other variables of the physical state through physical tests, effort, and perceived fatigue. The data will be statistically analyzed, and the hypotheses will be tested between the groups, using the SPSS software, v.24, considering a 95% confidence interval.
DISCUSSION


We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement. We intend to investigate a field not previously studied, such as the repercussion of carrying out a toning and respiratory exercise program in these patients, in historical circumstances that no one had previously observed in Spain, since the general population has never been forced to remain confined in their homes, due to a pandemic infection, by a coronavirus (COVID-19). Observing the effects that these two home exercise programs could produce in patients infected with COVID-19, we will try to better analyze and understand the mechanisms that are associated with the worsening of breathing in this type of patient.
TRIAL REGISTRATION


Brazilian Clinical Trial Registry RBR-6m69fc . Registered on March 31, 2020.",2020,"We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement.","['patients affected by COVID-19 during the period of home confinement', 'Patients will be recruited in the regions of Andalusia, Murcia, and Valencia (Spain', 'patients affected by COVID-19, confined to their homes', 'In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China']","['home exercise program (breathing exercises or non-specific exercises for muscle toning) and the third group will perform sedentary activities, using mental activation techniques, and will act as a sham group', 'Therapeutic pulmonary telerehabilitation protocol']",[],"[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.0649068,"We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement.","[{'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Gonzalez-Gerez', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Utrera', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain. cbernal495@gmail.com.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Anarte-Lazo', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Garcia-Vidal', 'Affiliation': 'Physiotherapy Department, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Jose Martin', 'Initials': 'JM', 'LastName': 'Botella-Rico', 'Affiliation': 'Physiotherapy Department, University Cardenal Herrera-CEU, Elche, Alicante, Spain.'}, {'ForeName': 'Cleofas', 'Initials': 'C', 'LastName': 'Rodriguez-Blanco', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain.'}]",Trials,['10.1186/s13063-020-04494-w']
1762,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779']
1763,32603994,A randomized-controlled examination of the effect of cognitive reappraisal instruction on maternal accommodation of child anxiety symptoms.,"Parental accommodation plays a key role in the maintenance of child anxiety, yet much of the research to date has been correlational, making it difficult to draw conclusions about underlying mechanisms. Given preliminary evidence that parental beliefs play a role in parental accommodation, the present study sought to experimentally reduce accommodation by targeting parental attitudes about child anxiety. Mothers of children ages 4-9 (N = 47) were randomly assigned to either receive brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON). At pre- and post-intervention mothers were presented with bogus information that their child was experiencing varying levels of distress while completing a task in a nearby room. Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress were measured pre- and post-intervention. EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers. EXP and CON mothers showed similar changes in negative affect. Findings from this study provide preliminary experimental evidence that targeting maternal beliefs about child anxiety can result in changes in maternal distress and behavior following exposure to child distress. Implications for prevention and treatment are discussed.",2020,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.",['Mothers of children ages 4-9 (N = 47'],"['cognitive reappraisal instruction', 'brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON']","['distress and perceived likelihood of accommodation', 'Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress', 'maternal accommodation of child anxiety symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",47.0,0.050831,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Department of Psychology, Florida International University, 11200 SW 8th Street, Miami, FL, 33199, United States.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102260']
1764,32611448,Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial).,"BACKGROUND


Esophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial to compare the two treatments for patients with pT1b ESCC.
METHODS


One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers and randomly assigned to the esophagectomy group or the dCRT group. The clinical lymph node status will be measured by image examination, including computer tomography and positron emission tomography-computed tomography. The pathological tumor status will be diagnosed after endoscopic submucosal dissection (ESD). All patients will be followed up for 60 months after randomization. The primary endpoint is 5-year overall survival. The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates.
DISCUSSION


To the best of our knowledge, this is the first phase III randomized controlled trial to compare esophagectomy and dCRT for patients with cN0-pT1b ESCC after ESD. Based on the results of this study, we will show whether dCRT will benefit patients more than esophagectomy, which will contribute more high-quality evidence to the primary salvage treatment for these patients.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04135664 . Registered on Aug. 10, 2019.",2020,"The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates.
","['patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection', 'pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER', 'One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers', 'patients with pT1b ESCC', 'patients with cN0-pT1b ESCC after ESD']","['ER followed with definitive chemoradiotherapy (dCRT', 'esophagectomy and dCRT', 'Esophagectomy versus definitive chemoradiotherapy', 'esophagectomy group or the dCRT', 'dCRT']","['quality of life', '5-year overall survival', 'quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",176.0,0.253509,"The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates.
","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hua', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Hezhong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Changhai Hospital, Naval Military Medical University, No. 168 Changhai Road, Shanghai, 200433, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China. zhigang_li_sch@163.com.'}]",Trials,['10.1186/s13063-020-04461-5']
1765,32620206,"[Intensification by high dose chemotherapy for germ-cell tumors, still an ongoing subject?]","More than 80 % of patient with metastatic germ cell tumor are cured with first line chemotherapy. Twenty to 30 % of patients will experience relapse or refractory disease with a very poor long-term prognosis. Most of them had metastatic germ cell tumors with a poor prognosis according to the international germ cell classification collaborative group (IGCCCG). The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy. The role of HDCT in first or second salvage is also not yet demonstrated, many studies have been published in this situation with a lot of different regimen. Outside clinical trial, HDCT remains an option in salvage therapy, depending on many factors including prognostics factors, previous therapy, general condition and reference center consideration to select eligible patient who could benefit the most of this approach. Results from the international randomized trial TIGER will provide evidence-based information for HDCT strategy.",2020,The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy.,[],"['high dose chemotherapy (HDCT', 'HDCT']",['experience relapse or refractory disease'],[],"[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0262045,The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy.,"[{'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Vinceneux', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France. Electronic address: armelle.vinceneux@lyon.unicancer.fr.'}, {'ForeName': 'Mélodie', 'Initials': 'M', 'LastName': 'Carbonnaux', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30277-0']
1766,32620210,Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve.,"BACKGROUND


The standard treatment in first line of advanced or metastatic urothelial bladder cancer (MBC) is the association of Gemcitabine and Cisplatin (GC). Avelumab, an anti-PD-L1 agent, has recently demonstrated efficacy. The objective is to evaluate the combination of these 3 agents.
METHODS


This phase II randomized open-label study, evaluated if GC-avelumab increases response rate and duration of response of patients in 1 st  line treatment for MBC compared to GC. Severe toxicities should not overlap and be acceptable. The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment. The study will recruit 90 participants, randomized in two arms (1:2), GC (gemcitabine 1 000 mg/m 2 /j, J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab (10 mg/Kg/3 semaines). Randomization will be stratified on Karnofsky status (≥ 80 % vs. < 80 %) and visceral vs non visceral metastases. The duration of the inclusion period is 24 months, with a duration of participation of each patient of 18 months and a total study duration of 42 months.
DISCUSSION


If both efficacy and safety of the association of GC+avelumab are in the range of acceptable through this specific study design, this will support a subsequent randomized phase III study comparing both arms with an overall survival end-point. In addition, the evaluation of predictive parameters to be confirmed (e.g. the impact of tumor PD-L1 expression) or other immunological parameters, may support a selection of the population. NCT number : NCT03324282.",2020,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"['patients with locally advanced or metastatic urothelial bladder carcinoma', '90 participants', 'first line of advanced or metastatic urothelial bladder cancer (MBC']","['GC-avelumab', 'Gemcitabine and Cisplatin (GC', 'GC+avelumab', 'GC (gemcitabine', 'gemcitabine cisplatin plus avelumab or gemcitabine cisplatin', 'J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab']","['Severe toxicities', 'objective response rate and the incidence of severe toxicity', 'response rate and duration of response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0699885', 'cui_str': 'Carcinoma of bladder'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",90.0,0.0457574,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France. Electronic address: marine.gross-goupil@chu-bordeaux.fr.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Domblides', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Lefort', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}]",Bulletin du cancer,['10.1016/S0007-4551(20)30280-0']
1767,32620212,BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer.,"BACKGROUND


The nivolumab-ipilimumab combination provides an overall response rate of 42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC). To date, there is no robust predictive biomarker of response to immune checkpoint inhibitor (ICI). In addition, severe autoimmune disorders occur more frequently with ICI combination than with ICI alone. The objective of this study is to compare the efficacy of ICI alone or in combination in patients according to tumor molecular characteristics.
METHODS


Using a 35-gene expression mRNA signature, patients were divided into 4 molecular groups (1 to 4). Patients in groups 1 and 4 were randomized to receive nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab for 4 injections followed by nivolumab alone (arms 1B and 4B). Patients in groups 2 and 3 were randomized to receive nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib at the investigator's choice (arms 2C and 3C)). The main objective is the overall response rate by treatment and molecular group.
DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC. This trial is the most appropriate to prospectively identify biomarkers of response to nivolumab used alone or in combination or TKI monotherapy in patients with mccRCC. NCT02960906.",2020,"DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","['naïve metastatic kidney cancer', '42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC', 'patients according to tumor molecular characteristics', 'patients with mccRCC', 'Using a 35-gene expression mRNA signature']","['nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI', 'nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab', 'nivolumab alone (arms 1B and 4B', 'nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib', 'nivolumab used alone or in combination or TKI monotherapy', 'ICI']","['overall response rate', 'severe autoimmune disorders']","[{'cui': 'C0862448', 'cui_str': 'Renal cell carcinoma stage IV'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}]",,0.0774426,"DISCUSSION


BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Epaillard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Simonaggio', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Fouzia', 'Initials': 'F', 'LastName': 'Azzouz', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Cheng-Ming', 'Initials': 'CM', 'LastName': 'Sun', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; INSERM U970. Paris Cardiovascular research Center (PARCC). Université Paris Descartes. Paris. France.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France. Electronic address: yann.vano@aphp.fr.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30283-6']
1768,32620213,Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO.,"BACKGROUND


Neoadjuvant cisplatin-based chemotherapy (NAC) is the standard of care in localized muscle-invasive bladder cancer (MIBC). However, 60-70% of patients have residual tumor after NAC. Based on the overall response rate observed in the metastatic setting, ddMVAC is the most commonly used NAC regimen in Europe. The emergence of immune checkpoint inhibitor (ICI) in the metastatic setting raises the question if the combination of chemo plus ICI could increase the pCR rate.
METHODS/DESIGN


NEMIO is a French open-label randomized phase I/II trial assessing in the neoadjuvant setting the combination of ddMVAC plus durvalumab alone or with tremelimumab: 4 cycles of ddMVAC/2 weeks + 2 cycles of Durvalumab +/- Tremelimumab/4 weeks. Cystectomy is performed 4-8 weeks after the last dose of ddMVAC. Six pts will be included in each arm in a safety run-in cohort to evaluate the toxicity rate. Each arm will be expanded to a maximum of 60 pts. The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE. The primary endpoint of the phase II will be the pathological response rate and G 3/4 TRAE. Exploratory endpoints will include biomarkers of response and resistance to the combo. A total of 120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021.
DISCUSSION


NEMIO trial will assess for the first time the tolerance and the efficacy of ddMVAC regimen associated with checkpoints inhibitors as neoadjuvant treatment in localized MIBC. NCT number: NCT03549715. Registered on June 8, 2018.",2020,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"['muscle-invasive urothelial carcinoma', '120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021']","['durvalumab and tremelimumab', 'ddMVAC/2 weeks + 2 cycles of Durvalumab ', 'ddMVAC', 'Neoadjuvant cisplatin-based chemotherapy (NAC', 'ddMVAC plus durvalumab alone or with tremelimumab', 'NEoadjuvant dose-dense MVAC']","['pathological response rate and G 3/4 TRAE', 'pCR rate', 'safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE', 'overall response rate', 'toxicity rate']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0065452', 'cui_str': 'M-VAC protocol'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",120.0,0.0661061,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"[{'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris. Electronic address: constance.thibault@aphp.fr.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Rouabah', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Helali', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Audenet', 'Affiliation': 'Department of urology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30281-2']
1769,32620666,Prognostic Impact of Geriatric Nutritional Risk Index in Patients With Synchronous Colorectal Liver Metastasis.,"BACKGROUND/AIM


The Geriatric Nutritional Risk Index (GNRI) is a prognostic indicator for several cancers; however, the association between the GNRI and colorectal liver metastasis (CRLM) remains unknown.
PATIENTS AND METHODS


Eighty patients who underwent hepatectomy for synchronous CRLM were divided into two groups based on the GNRI.
RESULTS


The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50). Patients in the low GNRI group had poorer outcomes than those in the normal GNRI group. A low GNRI was an independent prognostic factor for recurrence-free survival and overall survival. Among 50 patients who experienced recurrence, only 16 of 22 patients (72.7%) in the low GNRI group could receive intensive treatment and 27 of 28 patients (96.4%) in the normal GNRI group.
CONCLUSION


The GNRI is a simplified prognostic factor for patients with CRLM.",2020,The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50).,"['Eighty patients who underwent hepatectomy for synchronous CRLM', 'Patients With Synchronous Colorectal Liver Metastasis', 'patients with CRLM']",['Geriatric Nutritional Risk Index'],"['recurrence-free survival and overall survival', 'preoperative CA19-9 levels']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0201551', 'cui_str': 'Cancer antigen 19-9 measurement'}]",80.0,0.0206835,The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50).,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan tomo@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Sugimachi', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Mano', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Motomura', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ikebe', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Yoshizumi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Toh', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}]",Anticancer research,['10.21873/anticanres.14416']
1770,32620716,Comparison between mesh fixation and non-fixation in patients undergoing total extraperitoneal inguinal hernia repair.,"Background


The most important advantages of laparoscopic hernia repair include less postoperative pain, good cosmetic results, and early return to daily activities. Different methods and mesh types are used in inguinal hernia repair.
Aims


The objective of this study was to evaluate the complications and recurrence rates in patients who underwent laparoscopic inguinal hernia repair with and without mesh fixation.
Subjects and Methods


A total of 183 patients who underwent total extraperitoneal (TEP) inguinal hernia repair in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study. Patients were divided into two groups. Group 1 consisted of patients in whom 3D (Bard 3D Max) mesh was used and fixed with symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation. All statistical analyses were performed using SPSS 22.0 statistical package software. The differences were considered statistically significant if the P value was less than 0.05.
Results


In the study, 178 patients were included. The median age was 48 years. Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias. The mean follow-up duration was 45 months. The demographic data between the groups were similar. Operation time was 51.82 ± 18.87 min in group 1 and 52 ± 19.92 in group 2 (P = 0.089). No statistically significant difference was found between both groups in terms of the development of early and late complications. Intraoperative complications, port-site hernia, and mortality were not seen in any patient.
Conclusion


TEP seems to be a safe and effective surgical approach in inguinal hernia treatment with acceptable operation times and postoperative results. It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.",2020,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"['in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study', 'patients undergoing total extraperitoneal inguinal hernia repair', 'patients who underwent', 'Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias', 'Subjects and Methods\n\n\nA total of 183 patients who underwent', '178 patients were included']","['mesh fixation and non-fixation', 'laparoscopic inguinal hernia repair with and without mesh fixation', 'laparoscopic hernia repair', 'total extraperitoneal (TEP) inguinal hernia repair', 'symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation']","['complications and recurrence rates', 'morbidity and recurrence rates', 'Intraoperative complications, port-site hernia, and mortality', 'development of early and late complications', 'Operation time']","[{'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0034014', 'cui_str': 'Bone structure of pubis'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",178.0,0.0514192,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kabak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Tolan', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Canbak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_398_19']
1771,32620717,The effect of different mouthwashes on bacteremia after debonding.,"Objectives


This study aims to investigate the effects of various mouthwashes on bacteremia development following a debonding process, which is performed after orthodontic treatment.
Subjects and Methods


The study included patients who received fixed orthodontic treatment and were indicated for debonding. A total of 40 patients in four groups were selected for the study; no mouthwash (Group 1), mouthwash containing 0.12% chlorhexidine-gluconate (Group 2), mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine (Group 4). Before (T 0 ) and following (T 1 ) the debonding procedure, blood samples were obtained from the patients. Then, the blood samples were placed in blood culture bottles to investigate bacterial growth.
Results


Based on the results of the study, it was determined that the blood samples obtained at T 0 did not indicate any bacterial growth. Furthermore, it was observed that the blood samples obtained at T 1 included Streptococcus viridans, Streptococcus oralis, Streptococcus mutans, and Staphylococcus aereus growth, respectively, in 4 patients from Group 1 while Streptococcus salivarius growth was observed in 1 patient from Group 3 in addition to Streptococcus mitis growth in 1 patient from Group 4. No bacterial growth was observed in Group 2. While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
Conclusions


Finally, it was determined that the mouthwash 0.12% chlorhexidine-gluconate was statistically significant in comparison to the control group. It can be concluded that this mouthwash can be used to decrease bacterial density in oral flora before debonding procedures.",2020,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
","['Subjects and Methods', '40 patients in four groups were selected for the study; no mouthwash (Group 1']","['mouthwash containing 0.12% chlorhexidine-gluconate', 'chlorhexidine-gluconate', 'mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine', 'fixed orthodontic treatment']","['bacteremia', 'bacterial growth', 'Streptococcus salivarius growth', 'bacteremia development']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",40.0,0.0236568,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akbulut', 'Affiliation': 'Department of Orthodontics, Fırat University, Elazıǧ, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_664_19']
1772,32620810,Effect of occlusal splint on oxidative stress markers and psychological aspects of chronic temporomandibular pain: a randomized controlled trial.,"Temporomandibular disorders (TMD), when progress to a chronic state, might contribute to psychosocial or psychological distress. This study aimed to evaluate the effect of stabilization splint (SS) therapy on pain, pain-related disability and psychological traits of chronic TMD patients, as well as to assess selected oxidative stress (OS) biomarkers during 6-month treatment and associate them with the symptoms of anxiety and depression. Thirty-four participants were randomly assigned into two treatment groups [SS and placebo splint (PS)]. Primary outcomes were pain intensity and pain-related disability while secondary outcomes included depressive and anxiety symptoms. The influence of the treatment type was analyzed with regards to the levels of OS biomarkers in saliva. Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207). When compared to the PS group, participants in the SS group showed a significant reduction of oxidant/antioxidant ratio (p = 0.018, η 2  = 0.167) at a 3-month follow-up. A stabilization splint provides advantages over PS in the treatment of depressive symptoms and pain-related disability. Furthermore, clinical success in terms of reduction of depressive symptoms, which correlates with the reduction of oxidative stress markers in the SS group, indicates that oxidative stress is related to psychological factors in chronic TMD patients.",2020,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","['Thirty-four participants', 'chronic temporomandibular pain', 'chronic TMD patients', 'Temporomandibular disorders (TMD']","['occlusal splint', 'stabilization splint (SS) therapy', 'SS', 'placebo splint (PS', 'stabilization splint']","['oxidative stress markers', 'depressive symptoms scores', 'pain intensity and pain-related disability', 'oxidative stress (OS) biomarkers', 'depressive and anxiety symptoms', 'pain, pain-related disability and psychological traits', 'pain-related disability', 'oxidant/antioxidant ratio']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",34.0,0.0633455,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","[{'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Vrbanović', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia. evrbanovic@sfzg.hr.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Lapić', 'Affiliation': 'Medical Biochemistry and Laboratory Medicine, Department of Laboratory Diagnostics, University Hospital Centre Zagreb (KBCZ), Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vuletić', 'Affiliation': 'Department of Physiology, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]",Scientific reports,['10.1038/s41598-020-67383-x']
1773,32621467,[A study of the efficacy and safety of lornoxicam in patients with acute sciatica].,"OBJECTIVE


To compare the efficacy, safety and tolerability of lornoxicam and xefocam used as the reference drug in patients with acute nonspecific pain in lower back caused by acute sciatica.
MATERIAL AND METHODS


A simple blind clinical study was conducted with 108 patients (men and women, aged 20-55 years) with complaints of pain in the lower back and an established diagnosis of vertebrogenic radiculopathy L4, L5, S1. Patients were randomized into 2 treatment groups by randomization method of envelopes in the ratio of 1:1 (54 patients per group). The first group received lornoxicam in a dose of 16 mg/day for 2 days, the second group was treated with xefocam (the lyophilisate for preparation of solution for intravenous and intramuscular injection) according to a similar scheme.
RESULTS AND CONCLUSION


The results demonstrate the comparable efficacy of lornoxicam and the reference drug. The analysis of the safety profile reveals no significant differences between treatment groups.",2020,The analysis of the safety profile reveals no significant differences between treatment groups.,"['108 patients (men and women, aged 20-55 years) with complaints of pain in the lower back and an established diagnosis of vertebrogenic radiculopathy L4, L5, S1', 'patients with acute sciatica', 'patients with acute nonspecific pain in lower back caused by acute sciatica']","['lornoxicam and xefocam', 'lornoxicam', 'xefocam (the lyophilisate for preparation of solution for intravenous and intramuscular injection']","['efficacy and safety', 'efficacy, safety and tolerability']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0055477', 'cui_str': 'lornoxicam'}, {'cui': 'C4518549', 'cui_str': 'Lyophilisate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",108.0,0.034983,The analysis of the safety profile reveals no significant differences between treatment groups.,"[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Popov', 'Affiliation': 'Scientific Medical Center, JSC Russian Railways, Moscow, Russia.'}, {'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Gildeeva', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Butuzova', 'Affiliation': 'Medical Development Agency LLC, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Ezhova', 'Affiliation': 'Moscow Endocrine Plant, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Belostotskiy', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Bulanova', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012005142']
1774,32621874,"Efficacy of vitamin D 3  supplementation for the prevention of pulmonary tuberculosis and mortality in HIV: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Observational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D 3  supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART).
METHODS


This was a randomised, double-blind, placebo-controlled trial of vitamin D 3  supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D 3  supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D 3  supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed.
FINDINGS


Between Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D 3  supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D 3  group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D 3  supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85-1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D 3  (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54-1·13; p=0·19). The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D 3  group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80-1·41; p=0·66).
INTERPRETATION


Additional research is needed before vitamin D 3  supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality.
FUNDING


National Institute of Diabetes and Digestive and Kidney Diseases.",2020,"The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","['adults initiating antiretroviral therapy (ART', '6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018', '2001 patients', 'pulmonary tuberculosis and mortality in HIV', 'Between Feb 24, 2014, and Feb 24, 2017', 'mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence', 'adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania', 'people living with HIV', 'Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial']","['vitamin D 3  supplementation', 'vitamin D 3  supplements (cholecalciferol', 'placebo']","['Safety', '415 deaths', 'risk of hypercalcaemia', '101 hospital admissions', 'risk of mortality and incidence of pulmonary tuberculosis', 'death and incident pulmonary tuberculosis', 'risk of mortality (hazard ratio [HR', 'overall incidence of pulmonary tuberculosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",6250.0,0.791652,"The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: csudfeld@hsph.harvard.edu.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Mugusi', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alfa', 'Initials': 'A', 'LastName': 'Muhihi', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tumaini J', 'Initials': 'TJ', 'LastName': 'Nagu', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Biling', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30108-9']
1775,32621885,Low-Molecular-Weight Heparin vs Warfarin for Thromboprophylaxis in Children with Coronary Artery Aneurysms After Kawasaki Disease: A Pragmatic Registry Trial.,"BACKGROUND


The substantial risk of thrombosis in large coronary artery aneurysms (CAAs) (maximum z-score ≥ 10) after Kawasaki disease (KD) mandates effective thromboprophylaxis. We sought to determine the effectiveness of anticoagulation (low-molecular-weight heparin [LMWH] or warfarin) for thromboprophylaxis in large CAAs.
METHODS


Data from 383 patients enrolled in the International KD Registry (IKDR) were used. Time-to-event analysis was used to account for differences in treatment duration and follow-up.
RESULTS


From diagnosis onward (96% received acetylsalicylic acid concomitantly), 114 patients received LMWH (median duration 6.2 months, interquartile range [IQR] 2.5-12.7), 80 warfarin (median duration 2.2 years, IQR 0.9-7.1), and 189 no anticoagulation. Cumulative incidence of coronary artery thrombosis with LMWH was 5.7 ± 3.0%, with warfarin 6.7 ± 3.7%, and with no anticoagulation 20.6 ± 3.0% (P < 0.001) at 2.5 years after the start of thromboprophylaxis (LMWH vs warfarin HR 1.5, 95% confidence interval [CI] 0.4-5.1; P = 0.56). A total of 51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24 warfarin. There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19). Severe bleeding complications were generally rare (1.6 events per 100 patient-years) and were noted equally for patients on LMWH and warfarin (HR 2.3, 95% CI 0.6-8.9; P = 0.25).
CONCLUSIONS


LMWH and warfarin appear to have equivalent effectiveness for preventing thrombosis in large CAAs after KD, although event rates for secondary thromboprophylaxis and safety outcomes were low. Based on our findings, all patients with CAA z-score ≥ 10 should receive anticoagulation, but the choice of agent might be informed by secondary risk factors and patient preferences.",2020,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","['51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24', 'Children with Coronary Artery Aneurysms', 'Data from 383 patients enrolled in the International KD Registry (IKDR) were used']","['LMWH', 'acetylsalicylic acid', 'warfarin', 'anticoagulation (low-molecular-weight heparin [LMWH] or warfarin', 'LMWH and warfarin', 'Low-Molecular-Weight Heparin vs Warfarin']","['Cumulative incidence of coronary artery thrombosis', 'Severe bleeding complications', 'incidence of further coronary artery thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",383.0,0.190654,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Tisiana', 'Initials': 'T', 'LastName': 'Low', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagib', 'Initials': 'N', 'LastName': 'Dahdah', 'Affiliation': 'Division of Pediatric Cardiology, Centre Hospitalier Universitaire Ste-Justine, University of Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Raghuveer', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Therese M', 'Initials': 'TM', 'LastName': 'Giglia', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dallaire', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Mathew', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Runeckles', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Harahsheh', 'Affiliation': ""Pediatrics-Cardiology, Children's National Health System/George Washington University, Washington, District of Columbia, USA.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': 'Department of Paediatrics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Friedman', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kutty', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Mondal', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada. Electronic address: brian.mccrindle@sickkids.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.016']
1776,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States; Department of Medicine, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072']
1777,32621918,Dexmedetomidine pretreatment attenuates myocardial ischemia reperfusion induced acute kidney injury and endoplasmic reticulum stress in human and rat.,"BACKGROUND


Patients undergoing cardiopulmonary bypass (CPB) often develop acute kidney injury (AKI) caused by myocardial ischemia reperfusion (MI/R), and this renal injury can be resolved notably by dexmedetomidine. Endoplasmic reticulum (ER) stress was reported to get involved in organ injury including AKI.
OBJECTIVES


The current study aimed to address the correlation between MI/R induced AKI with ER stress and to assess the effects of dexmedetomidine pretreatment on AKI protection.
METHOD


Patients selected for heart valve replacement surgery were randomly assigned to NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine). Rat MI/R model was induced by occluding coronary artery for 30 min followed by 48-hour reperfusion. Rats were randomized into Sham (0.9% NaCl), I/R (MI/R + 0.9% NaCl) and I/R + DEX (MI/R + dexmedetomidine). Organ function and ER stress condition were evaluated by blood chemistry, pathology, and molecular test.
RESULTS


Clinical data indicated dexmedetomidine pretreatment attenuated AKI and oxidative stress as well as postischemic myocardial injury in patients. Accordingly animal results suggested dexmedetomidine reduced cellular injury and improved postischemic myocardial and renal function. Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
CONCLUSIONS


These results suggested that dexmedetomidine pretreatment attenuates MI/R injury-induced AKI by relieving the ER stress.",2020,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","['Patients undergoing', 'Patients selected for heart valve replacement surgery', 'human and rat']","['cardiopulmonary bypass (CPB', 'NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine', 'Dexmedetomidine', '\u202fDEX (MI/R\u202f+\u202fdexmedetomidine', 'dexmedetomidine']","['MI/R injury-induced AKI', 'Endoplasmic reticulum (ER) stress', 'AKI and oxidative stress', 'myocardial and renal cells apoptosis and down-regulated ER stress', 'cellular injury and improved postischemic myocardial and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0014239', 'cui_str': 'Endoplasmic reticulum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0396497,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: chaolt@ustc.edu.cn.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02144, USA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency, Huashan Hospital North, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Xinghan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Laboratory, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230000, Anhui, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: xiaoqingchai@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118004']
1778,32627064,"The analgesic effect of tramadol combined with butorphanol on uterine cramping pain after repeat caesarean section: a randomized, controlled, double-blind study.","PURPOSE


This study aimed to explore the effect of patient-controlled intravenous analgesia (PCIA) using tramadol combined with butorphanol on uterine cramping pain in women undergoing repeat caesarean section.
METHODS


A total of 126 patients, who were scheduled to undergo repeat caesarean section under spinal anesthesia, were included. PCIA using tramadol combined with butorphanol or sufentanil was randomly performed for postoperative pain control. Postoperative uterine cramping pain and wound pain within 48 h after surgery were evaluated. Postoperative analgesic consumption, early activity time, and length of hospital stay were also recorded and analyzed.
RESULTS


Uterine cramping pain intensity in women undergoing repeat caesarean section was significantly higher compared with their wound pain (P < 0.05). The mean visual analog scale (VAS) score for uterine cramping pain in the tramadol-butorphanol group was significantly lower than that in the sufentanil group at rest, and at 6 h and 12 h after surgery. VAS scores for uterine cramping pain during movement at 6 h, 12 h, and 24 h after surgery in the tramadol-butorphanol group were also significantly lower than that in sufentanil group (P < 0.05). There was no significant difference in VAS score for wound pain at the different time points between the tramadol-butorphanol and sufentanil groups (P > 0.05). Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
CONCLUSION


PCIA using tramadol combined with butorphanol provided a better analgesic effect and accelerated postoperative rehabilitation compared with sufentanil, and may be an optimal analgesic strategy for women undergoing repeat caesarean section.
CLINICAL TRIAL REGISTRATION


The trial was registered at Chinese Clinical Trial Registry ( www.chictr.org.cn ) with ID: ChiCTR-1800014986.",2020,"Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
","['uterine cramping pain after repeat caesarean section', 'women undergoing repeat caesarean section', '126 patients, who were scheduled to undergo repeat caesarean section under spinal anesthesia, were included']","['butorphanol', 'sufentanil', 'tramadol', 'tramadol-butorphanol', 'butorphanol or sufentanil', 'tramadol combined with butorphanol', 'patient-controlled intravenous analgesia (PCIA']","['Uterine cramping pain intensity', 'wound pain', 'VAS score for wound pain', 'uterine cramping pain', 'mean visual analog scale (VAS) score for uterine cramping pain', 'length of hospital stay', 'postoperative pain control', 'Postoperative uterine cramping pain and wound pain', 'Postoperative analgesic consumption, early activity time, and length of hospital stay', 'analgesic effect and accelerated postoperative rehabilitation', 'VAS scores']","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0241745', 'cui_str': 'Wound pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",126.0,0.264415,"Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, General Hospital of Central Theater Command, Wuhan, China.'}, {'ForeName': 'Hanlin', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. qq8689948@126.com.'}]",Journal of anesthesia,['10.1007/s00540-020-02820-9']
1779,32627071,Percutaneous electrical stimulation of the posterior tibial nerve for the treatment of fecal incontinence: manometric results after 6 months of treatment.,"BACKGROUND


Posterior tibial nerve stimulation (PTNS) is a minimally invasive approach with little adverse effects, but obtaining good results as shown in the different scales for the evaluation of the severity of incontinence. The aim of this study was to determine the effects of PTNS based on manometric determinations of the anal sphincter and severity during a period of treatment of 6 months (18 sessions).
PATIENTS AND METHODS


A prospective interventional study of patients with fecal incontinence was performed. Subjects underwent one 30-min session every week for 12 weeks, followed by 6 sessions every 2 weeks. The effect on incontinence was evaluated by means of St. Marks and defecatory urgency scales, and manometry.
RESULTS


Seventy-three patients were included. At baseline, 28.8% of the patients had a retention time of less than 1 min. At 12 weeks, 39.7% of the patients presented a retention time to 5-10 min and at 18 weeks 37% presented it over 10 min. At baseline, mean St Marks score was 15.1 + 5.1, improving after 12 weeks of treatment to 8.9 + 5 (p < 0.001). After 18 sessions, a greater improvement was observed up to 4 + 4.8 (p < 0.001). Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006). Similarly, maximum squeeze pressure also presented a significant augmentation (mean increase 25.3 mmHg; p = 0.002).
CONCLUSION


Eighteen sessions of PTNS, divided in 12 weekly sessions and 6 sessions every 2 weeks, have shown to obtain benefits, reducing the St. Marks and the defecatory urgency scores, and increasing the manometric values.",2020,Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006).,"['fecal incontinence', 'patients with fecal incontinence', 'Seventy-three patients were included']","['Percutaneous electrical stimulation', 'Posterior tibial nerve stimulation (PTNS', 'PTNS']","['Maximum resting pressure', 'St. Marks and defecatory urgency scales, and manometry', 'mean St Marks score', 'retention time', 'maximum squeeze pressure']","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}]",73.0,0.0330054,Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006).,"[{'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Manso', 'Affiliation': 'International Doctorate School, Faculty of Health Sciences, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alias', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Levano-Linares', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Laiz', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Garcia-Olmo', 'Affiliation': 'Department of Surgery, Fundacion Jimenez Diaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Faculty of Health Sciences, Rey Juan Carlos University, Madrid, Spain. jruiztovar@gmail.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03564-4']
1780,32627073,"A randomized, double-blind, parallel-group, single‑dose, pharmacokinetic bioequivalence study of INTP24 and bevacizumab in healthy adult men.","PURPOSE


To demonstrate pharmacokinetic (PK) equivalence and to compare safety of INTP24 (bevacizumab biosimilar) with that of US-bevacizumab and EU-bevacizumab in healthy male subjects.
METHODS


In this randomized, parallel-group, double-blind study, male subjects were randomized (1:1:1) to receive a single 1 mg/kg intravenous infusion of either INTP24, US-bevacizumab, or EU-bevacizumab. The primary endpoint was area under serum concentration (AUC) from time zero to infinity (AUC 0-∞ ). Secondary endpoints were AUC from time zero to last quantifiable concentration (AUC 0-t ), maximum concentration (C max ), other PK parameters, immunogenicity, and safety.
RESULTS


A total of 117 subjects (39/group) were dosed; 113 subjects (37, 37, and 39 in INPT24, US-bevacizumab, and EU-bevacizumab groups, respectively) completed the study and were included in the PK analysis. Baseline demographics were similar across the three groups. The 90% confidence intervals (CI) of geometric mean ratios (GMR) of ln-transformed AUC 0-∞  and C max  of INTP24 relative to US-bevacizumab and EU-bevacizumab were within the acceptance range of 80%-125% (INTP24 vs. US-bevacizumab, 96.55-112.51% and 99.16-112.79%: INTP24 vs. EU-bevacizumab, 94.84-110.17% and 96.32-109.28%). The 90% CIs of GMRs for AUC 0-t  was also within 80-125% for INTP24 vs. US-bevacizumab and INTP24 vs. EU-bevacizumab. Safety and immunogenicity profiles were similar across the three groups. Twenty-one (17.95%) subjects experienced at least one AE and 9 (7.69%) were ADA positive. One treatment-related serious adverse event (varicella zoster infection) was reported in INTP24 group.
CONCLUSION


This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.",2020,This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.,"['male subjects', 'healthy adult men', 'healthy male subjects', '117 subjects (39/group) were dosed; 113 subjects (37, 37, and 39 in', 'groups, respectively) completed the study and were included in the PK analysis']","['INPT24, US-bevacizumab, and EU-bevacizumab', 'INTP24 to US-bevacizumab and EU-bevacizumab', 'INTP24, US-bevacizumab, or EU-bevacizumab', 'INTP24 vs. US-bevacizumab and INTP24 vs. EU-bevacizumab', 'INTP24', 'INTP24 and bevacizumab', 'bevacizumab', 'bevacizumab biosimilar) with that of US-bevacizumab and EU-bevacizumab']","['AUC from time zero to last quantifiable concentration (AUC 0-t ), maximum concentration (C max ), other PK parameters, immunogenicity, and safety', 'serious adverse event (varicella zoster infection', 'confidence intervals (CI) of geometric mean ratios (GMR) of ln-transformed AUC 0-∞  and C max  of INTP24 relative to US-bevacizumab and EU-bevacizumab', 'Safety and immunogenicity profiles', 'ADA positive', 'area under serum concentration (AUC) from time zero to infinity (AUC 0-∞ ', 'pharmacokinetic (PK) equivalence']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0586989', 'cui_str': 'Varicella-zoster virus infection'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",117.0,0.205122,This study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.,"[{'ForeName': 'Inderjeet', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Intas Pharmaceuticals Ltd. (Biopharma Division), Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, 382213, India.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd., Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad, Gujarat, 382481, India.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Lambda Therapeutic Research Ltd., Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad, Gujarat, 382481, India.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Jose', 'Affiliation': 'Intas Pharmaceuticals Ltd. (Biopharma Division), Plot No: 423/P/A, Sarkhej-Bavla Highway, Moraiya, Sanand, Ahmedabad, Gujarat, 382213, India. vinu_jose@intaspharma.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04111-2']
1781,32627192,Caring for others without losing yourself: An adaptation of the Mindful Self-Compassion Program for Healthcare Communities.,"OBJECTIVE


Two studies examined the efficacy of the Self-Compassion for Healthcare Communities (SCHC) program for enhancing wellbeing and reducing burnout among healthcare professionals.
METHOD


Study 1 (N = 58) had a quasi-experimental design and compared wellbeing outcomes for the SCHC group compared to a waitlist control group. Study 2 (N = 23) did not include a control group and examined the effect of SCHC on burnout.
RESULTS


Study 1 found that SCHC significantly increased self-compassion and wellbeing. All gains were maintained for three months. Study 2 found that in addition to enhancing wellbeing, SCHC significantly reduced secondary traumatic stress and burnout. Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
CONCLUSIONS


Findings suggest that the SCHC program may be an effective way to increase self-compassion, enhance wellbeing, and reduce burnout for healthcare professionals.",2020,"Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
",['Study 1 (N\u2009=\u200958'],"['Self-Compassion for Healthcare Communities (SCHC) program', 'SCHC', 'waitlist control group']","['self-compassion and wellbeing', 'self-compassion, enhance wellbeing', 'secondary traumatic stress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}]",,0.0128047,"Changes in self-compassion explained gains in other outcomes, and initial levels of self-compassion moderated outcomes so that those initially low in self-compassion benefitted more.
","[{'ForeName': 'Kristin D', 'Initials': 'KD', 'LastName': 'Neff', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Marissa C', 'Initials': 'MC', 'LastName': 'Knox', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Long', 'Affiliation': ""Center for Resiliency, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.""}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Gregory', 'Affiliation': ""Center for Resiliency, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.""}]",Journal of clinical psychology,['10.1002/jclp.23007']
1782,32627205,"Blood Donor Recruitment in Guangzhou, China, during the 2019 Novel Coronavirus (COVID-19) Epidemic.","BACKGROUND


The coronavirus disease 2019 (COVID-19) epidemic affected blood collection in Guangzhou, China.
STUDY DESIGN AND METHODS


This paper included three studies. The observational study reported the trends of blood collection during the epidemic in Guangzhou, China. The cross-sectional survey investigated factors influencing blood donation during the COVID-19 epidemic, and a self-administered questionnaire was given to 1,584 street whole blood donors (SWBDs) who donated during the epidemic. The randomized controlled trial involved 19,491 SWBDs who donated in 2019 but did not donate during the epidemic. Trial participants were randomly assigned to two intervention groups: group 1 completed Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information. A control group did not receive any questionnaire.
RESULTS


As measures implemented, the number of blood donors increased accordingly. Both first-time and repeat SWBDs perceived the same level of blood need and donated blood because it would save lives. SWBDs who completed Questionnaire 1 expressed a greater intention to donate during the epidemic. Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks. Intention-to-treat analyses and average-treatment-effect-on-the-treated estimations confirmed that Questionnaire 1 could motivate SWBDs to actually donate blood.
CONCLUSION


Various measures could ease blood shortage during the COVID-19 epidemic. Administration of Questionnaire 1 could increase blood donations during the epidemic. This article is protected by copyright. All rights reserved.",2020,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"['19,491 SWBDs who donated in 2019 but did not donate during the epidemic']","['Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information']","['blood donations', 'number of blood donors', 'blood shortage']","[{'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",19491.0,0.0277604,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ou-Yang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shi-Jie', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chun-Hua', 'Initials': 'CH', 'LastName': 'Bei', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jin-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua-Qin', 'Initials': 'HQ', 'LastName': 'Liang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yong-Shui', 'Initials': 'YS', 'LastName': 'Fu', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}]",Transfusion,['10.1111/trf.15971']
1783,32627352,Phase 3 Trial of Human Islet-after-Kidney Transplantation in Type 1 Diabetes.,"Allogeneic islet transplantation offers a minimally invasive option for β-cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplantation (CIT06), a National Institutes of Health (NIH)-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy (IIT). PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events (SHE) and HbA1c≤6.5% or reduced by ≥ 1 percentage point at 1-year post transplant. Median HbA1c declined from 8.1% before to 6.0% at 1-year and 6.3% at 2- and 3-years following transplantation (p<0.001 for all vs. baseline), with related improvements in hypoglycemia awareness and glucose variability. The improved metabolic control was associated with better health-related and diabetes-related quality-of-life. The procedure was safe and kidney allograft function remained stable after 3-years. These results add to evidence establishing allogeneic islet transplantation as a safe and effective treatment for patients with T1D and unstable glucose control despite intensive insulin treatment, supporting the indication for PHPI in the post renal transplant setting.",2020,PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events (SHE) and HbA1c≤6.5% or reduced by ≥ 1 percentage point at 1-year post transplant.,"['Type 1 Diabetes', 'patients with T1D after kidney transplantation (CIT06', 'patients with T1D and unstable glucose control', '24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy (IIT']","['purified human pancreatic islets (PHPI', 'Allogeneic islet transplantation', 'allogeneic islet transplantation', 'PHPI transplantation', 'Human Islet-after-Kidney Transplantation']","['metabolic control', 'safe and kidney allograft function', 'hypoglycemia awareness and glucose variability', 'health-related and diabetes-related quality-of-life', 'Median HbA1c', 'severe hypoglycemic events (SHE']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022131', 'cui_str': 'Endocrine pancreatic structure'}, {'cui': 'C0079646', 'cui_str': 'Islet cell transplant'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",24.0,0.0166347,PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events (SHE) and HbA1c≤6.5% or reduced by ≥ 1 percentage point at 1-year post transplant.,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Markmann', 'Affiliation': 'Division of Transplant Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Rickels', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Eggerman', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Bridges', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Lafontant', 'Affiliation': 'Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Qidwai', 'Affiliation': 'Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Foster', 'Affiliation': 'Ferring Pharmaceuticals, Parsippany, NJ, USA.'}, {'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Clarke', 'Affiliation': 'Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kamoun', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Alejandro', 'Affiliation': 'Diabetes Research Institute and Clinical Cell Transplant Program, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellin', 'Affiliation': 'Department of Endocrinology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chaloner', 'Affiliation': 'Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Czarniecki', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Goldstein', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Hering', 'Affiliation': 'Schulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Hunsicker', 'Affiliation': 'Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kaufman', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Korsgren', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Naji', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Oberholzer', 'Affiliation': 'Department of Surgery, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Posselt', 'Affiliation': 'Department of Surgery, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ricordi', 'Affiliation': 'Diabetes Research Institute and Clinical Cell Transplant Program, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Senior', 'Affiliation': 'Clinical Islet Transplant Program and Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Amj', 'Initials': 'A', 'LastName': 'Shapiro', 'Affiliation': 'Clinical Islet Transplant Program and Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'Department of Surgery, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Turgeon', 'Affiliation': 'Department of Surgery, University of Texas Dell Medical School, Austin, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16174']
1784,32627354,Relation between plasma ceramides and cardiovascular death in chronic heart failure: A subset analysis of the GISSI-HF trial.,"AIMS


Ceramides exert several biological activities that may contribute to the pathophysiology of cardiovascular disease and heart failure (HF). The association between plasma levels of distinct ceramides (that have been previously associated with increased cardiovascular risk) and cardiovascular mortality in patients with chronic HF has received little attention.
METHODS AND RESULTS


In a post hoc ancillary analysis of the Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure (GISSI-HF; NCT00336336) trial, we randomly selected a sample of 200 ambulatory patients with chronic HF who died due to cardiovascular causes and 200 patients who were alive at the end of the trial (after a median follow-up period of 3.9 years). We measured baseline plasma concentrations of six previously identified high-risk ceramide species [Cer(d18:1/16:0), Cer(d18:1/18:0), Cer(d18:1/20:0), Cer(d18:1/22:0), Cer(d18:1/24:0), and Cer(d18:1/24:1) and their individual plasma ratios with Cer(d18:1/24:0)]. Patients who died due to cardiovascular causes had significantly (P < 0.05 or less) higher levels of plasma Cer(d18:1/16:0) and Cer(d18:1/24:1), but lower levels of plasma Cer(d18:1/22:0) and Cer(d18:1/24:0) than had those who did not. All plasma ratios of each ceramide with Cer(d18:1/24:0) were significantly higher in patients who died due to cardiovascular causes. In Cox regression analyses, all five plasma ratios of each ceramide with Cer(d18:1/24:0) were significantly associated with a greater risk of cardiovascular mortality (with unadjusted hazard ratios ranging from 1.23 to 1.59; P < 0.001 or less). These significant associations were attenuated after adjustment for multiple established risk factors, New York Heart Association functional class, left ventricular ejection fraction, use of medications, plasma pentraxin-3 levels, and, especially, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. When we applied a Bonferroni correction for multiple comparisons (using a P-threshold 0.05/5 ceramide ratios = 0.01), none of the five plasma ratios of each ceramide with Cer(d18:1/24:0) remained statistically associated with the risk of cardiovascular mortality (with adjusted hazard ratios ranging from 1.10 to 1.23).
CONCLUSIONS


Higher levels of specific plasma ceramides [especially when used in ratios with Cer(d18:1/24:0)] are associated with increased cardiovascular mortality in ambulatory patients with chronic HF. However, these associations are weakened after adjustment for established cardiovascular risk factors, medication use, and plasma NT-proBNP concentrations.",2020,"Patients who died due to cardiovascular causes had significantly (P < 0.05 or less) higher levels of plasma Cer(d18:1/16:0) and Cer(d18:1/24:1), but lower levels of plasma Cer(d18:1/22:0) and Cer(d18:1/24:0) than had those who did not.","['ambulatory patients with chronic HF', 'chronic heart failure', 'patients with chronic HF', '200 ambulatory patients with chronic HF who died due to cardiovascular causes and 200 patients who were alive at the end of the trial (after a median follow-up period of 3.9\xa0years']",[],"['established cardiovascular risk factors, medication use, and plasma NT-proBNP concentrations', 'All plasma ratios of each ceramide with Cer(d18:1/24:0', 'cardiovascular risk) and cardiovascular mortality', 'multiple established risk factors, New York Heart Association functional class, left ventricular ejection fraction, use of medications, plasma pentraxin-3 levels, and, especially, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels', 'cardiovascular mortality', 'risk of cardiovascular mortality']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",200.0,0.0417072,"Patients who died due to cardiovascular causes had significantly (P < 0.05 or less) higher levels of plasma Cer(d18:1/16:0) and Cer(d18:1/24:1), but lower levels of plasma Cer(d18:1/22:0) and Cer(d18:1/24:0) than had those who did not.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Targher', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Piazzale Stefani, 1, Verona, 37126, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Lunardi', 'Affiliation': ""Medical Analysis Laboratory, 'IRCCS Sacro Cuore-Don Calabria' Hospital, Negrar, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mantovani', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Piazzale Stefani, 1, Verona, 37126, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Meessen', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bonapace', 'Affiliation': ""Division of Cardiology, 'IRCCS Sacro Cuore-Don Calabria' Hospital, Negrar, Italy.""}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Temporelli', 'Affiliation': 'Division of Cardiology, Istituti Clinici Scientifici Maugeri, IRCCS, Veruno, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Nicolis', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Conti', 'Affiliation': ""Medical Analysis Laboratory, 'IRCCS Sacro Cuore-Don Calabria' Hospital, Negrar, Italy.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Tavazzi', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy.'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}]",ESC heart failure,['10.1002/ehf2.12885']
1785,32627420,"A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.","ABP 798 is a proposed biosimilar to rituximab reference product (RP), an anti-CD20 monoclonal antibody. Pharmacokinetics (PK), pharmacodynamics (PD), and safety results from the comparative clinical study that evaluated the PK, PD, safety, efficacy, and immunogenicity of ABP 798 versus rituximab RP are presented here. Subjects with moderate to severe rheumatoid arthritis (RA) received 2 doses of ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU), each consisting of two 1000-mg infusions 2 weeks apart. For the second dose (week 24), ABP 798- and rituximab EU-treated subjects received the same treatment; rituximab US-treated subjects transitioned to ABP 798. End points included area under the serum concentration-time curve from time 0 extrapolated to infinity and maximum observed serum concentration following the second infusion of the first dose (PK) and percentage of subjects with complete CD19+ cell depletion days 1-33 (PD). Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25. Complete CD19+ B-cell depletion on day 3 among groups confirmed PD similarity. These findings demonstrated PK/PD similarity between ABP 798 and rituximab RP in subjects with moderate to severe RA.",2020,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"['Subjects With Moderate to Severe Rheumatoid Arthritis', 'subjects with moderate to severe RA', 'Subjects with moderate to severe rheumatoid arthritis (RA']","['ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU']","['PK, PD, safety, efficacy, and immunogenicity', 'Complete CD19+ B-cell depletion', 'area under the serum concentration-time curve', 'Pharmacokinetics (PK), pharmacodynamics (PD), and safety']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0433337,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Clinical Pharmacology M&S, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gessner', 'Affiliation': 'Clinical Immunology, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, Texas, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.845']
1786,32627438,Effects of Repetitive Transcranial Magnetic Stimulation on Improvement of Mental Health and Clinical Parameters in Depressed Hemodialysis Patients: a Pilot Study.,"BACKGROUND


This study aimed to evaluate the therapeutic effect of repetitive transcranial magnetic stimulation (rTMS) as a nonpharmacologic treatment in depressed hemodialysis patients.
METHODS


Patients who scored ≥ 5 on the Patient Health Questionnaire-9 were randomized to either the rTMS (n = 7) or sham group (n = 7). The rTMS group was stimulated with a 110% motor threshold and 10 Hz on the left dorsolateral prefrontal cortex for 20 minutes, three times a week, for 4 weeks. In the sham group, the ""1-wing 90-degree method"" was used. We analyzed clinical indices before and after the intervention, as well as data from quantitative electroencephalography (frontal alpha asymmetry [FAA]), and various psychiatric questionnaires (Beck Depression Inventory-II, Beck Anxiety Inventory [BAI], Symptom Checklist-90-Revised Somatization Subscale [SCL-90R-SOM]), and Perceived Stress Scale.
RESULTS


One month after rTMS, the changes in hemoglobin A1c levels in the rTMS group were significantly greater than those in the sham group ( F  = 6.687,  P  = 0.032). The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048). In addition, the changes in the FAA value at the F7 and F8 electrodes in the rTMS group were greater than those in the sham group ( F  = 6.468,  P  = 0.027).
CONCLUSION


In depressed hemodialysis patients, rTMS may improve anxiety and somatization symptoms, which may lead to improvements in clinical measures. Trial Registration Clinical Research Information Service Identifier: KCT0004082.",2020,"The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048).","['depressed hemodialysis patients', 'Patients who scored ≥ 5 on the Patient Health Questionnaire-9', 'Depressed Hemodialysis Patients']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['SCL-90R-SOM scores', 'FAA value at the F7 and F8 electrodes', 'anxiety and somatization symptoms', 'BAI scores', 'quantitative electroencephalography (frontal alpha asymmetry [FAA]), and various psychiatric questionnaires (Beck Depression Inventory-II, Beck Anxiety Inventory [BAI], Symptom Checklist-90-Revised Somatization Subscale [SCL-90R-SOM]), and Perceived Stress Scale', 'Mental Health and Clinical Parameters', 'hemoglobin A1c levels']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",,0.0172177,"The changes in BAI scores in the rTMS group were significantly greater than those in the sham group ( F  = 6.700,  P  = 0.025), and the changes in SCL-90R-SOM scores in the rTMS group were greater than those in the sham group ( F  = 4.943,  P  = 0.048).","[{'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Hyunchan', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Hye Ri', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Doug Hyun', 'Initials': 'DH', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.'}, {'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chung-Ang University Hospital, Seoul, Korea. sunmikim706@gmail.com.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e205']
1787,32627564,Memory Strategy Training Can Enhance Psychoeducation Outcomes for Dementia Family Caregivers: A Randomized Controlled Trial.,"This study investigated caregiver outcomes when a psychoeducation program for older people with dementia and caregivers is modified to extend practice in memory strategies. Moderation effects of increased memory strategy use were also explored. Fifty-six care dyads participated in the multicenter, randomized controlled trial comparing psychoeducation (active control) with psychoeducation and memory strategy practice (intervention). Primary outcome was memory strategy use; secondary outcome was caregiver emotional reactivity (burden, depression, and anxiety). Results showed memory strategy use significantly increased following psychoeducation for both groups. However, psychoeducation combined with memory strategy practice resulted in a significant reduction in depression for caregivers reporting at least mild baseline symptoms. Greater use of memory strategies moderated the relationship between burden and depression following intervention. Psychoeducation programs that incorporate practical memory strategy training may offer more substantial outcomes.",2020,Results showed memory strategy use significantly increased following psychoeducation for both groups.,"['Fifty-six care dyads', 'Dementia Family Caregivers', 'older people with dementia and caregivers']","['psychoeducation (active control) with psychoeducation and memory strategy practice (intervention', 'Memory Strategy Training', 'psychoeducation program']","['memory strategy use; secondary outcome was caregiver emotional reactivity (burden, depression, and anxiety', 'memory strategy use']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589105', 'cui_str': 'Strategy training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",56.0,0.244748,Results showed memory strategy use significantly increased following psychoeducation for both groups.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'McAuliffe', 'Affiliation': '2080 97586 Department of Psychology and Counselling, School of Psychology and Public Health, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Wright', 'Affiliation': '2080 97586 Department of Psychology and Counselling, School of Psychology and Public Health, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glynda', 'Initials': 'G', 'LastName': 'Kinsella', 'Affiliation': '2080 97586 Department of Psychology and Counselling, School of Psychology and Public Health, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.'}]",International journal of aging & human development,['10.1177/0091415020933244']
1788,32627570,Multi-component communication intervention for children with autism: A randomized controlled trial.,"LAY ABSTRACT


This study reports the results of a randomized trial for preverbal preschoolers with autism that demonstrates the effects of multiple intervention strategies including caregiver training. About 50% of children with autism are not talking by age 3 and up to 30% of children with autism will remain minimally verbal past age 5. Interventions delivered by clinicians and caregivers have the greatest effects on spoken language and may reduce the rate of those who remain minimally verbal. Sixty-eight children ages 3-5 with autism and their caregivers participated in this randomized trial comparing the communication intervention to a comparison group. A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention. Future research is needed to understand for whom and under what conditions this intervention is most effective.",2020,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","['children with autism', 'Sixty-eight children ages 3-5 with autism and their caregivers participated', 'preverbal preschoolers with autism']","['Multi-component communication intervention', 'multi-component, communication intervention (including a speech-generating device', 'communication intervention']",['joint attention skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.043766,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Hampton', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Kaiser', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Fuller', 'Affiliation': 'Vanderbilt University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934558']
1789,32627589,"Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.","BACKGROUND/AIMS


Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients.
METHODS


Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features.
RESULTS


In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
CONCLUSIONS


Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.",2020,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","['to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures']","['social media (Facebook), targeted mailing, and in-person solicitation']","['cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability']","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",3.0,0.147519,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Carandang', 'Affiliation': 'University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Cheryl Lp', 'Initials': 'CL', 'LastName': 'Vigen', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Concha-Chavez', 'Affiliation': 'Northern Arizona University, Phoenix, AZ, USA.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Sequeira', 'Affiliation': 'Los Angeles Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520933362']
1790,32627592,Feasibility of a psychoeducational group intervention to improve parental reflective functioning and bonding in pregnancy: a randomised trial.,"OBJECTIVE


To develop and evaluate Baby CHAT, a single-session psychoeducational intervention for expectant parents. Baby CHAT aims to improve parental reflective functioning (RF) and bonding.
BACKGROUND


The early years of a child's life, including pregnancy, are vital for healthy physical and emotional development. Caregivers who provide responsive parenting, enhanced through strong bonds and good RF, can aid healthy development.. However, limited interventions exist to enhance RF and bonding in expectant parents.
METHODS


Feasibility of Baby CHAT was assessed using a mixed methods randomised controlled trial design. It evaluated uptake and retention of participants, effect size calculations, and acceptability and satisfaction with Baby CHAT.
RESULTS


Participants (N = 20) were aged 30-39 years (n = 17) in their third trimester of pregnancy (n = 12). Nine males and 11 females were recruited. Content analysis of qualitative feedback after the intervention resulted in four themes; positive group aspects, group improvements, 4D scan footage and relating content to my baby.
CONCLUSIONS


Baby CHAT can help expectant parents think about their baby as a separate person and has potential to improve prenatal RF and bonding. However, further research is required to assess the effectiveness of Baby CHAT to improve bonding and RF.",2020,"CONCLUSIONS


Baby CHAT can help expectant parents think about their baby as a separate person and has potential to improve prenatal RF and bonding.","['Nine males and 11 females were recruited', 'Participants (N\xa0=\xa020) were aged 30-39\xa0years ', 'expectant parents']","['Baby CHAT', 'psychoeducational group intervention']","['4D scan footage and relating content to my baby', 'uptake and retention of participants, effect size calculations, and acceptability and satisfaction with Baby CHAT', 'parental reflective functioning (RF) and bonding', 'parental reflective functioning and bonding in pregnancy']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",20.0,0.130637,"CONCLUSIONS


Baby CHAT can help expectant parents think about their baby as a separate person and has potential to improve prenatal RF and bonding.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cox', 'Affiliation': 'Clinical Psychology Department, Royal Holloway University , London, UK.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading , Reading, UK.'}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': 'Centre for Parent and Child Support, South London and Maudsley NHS Foundation Trust, Michael Rutter Centre , Camberwell, London.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Reissland', 'Affiliation': 'Department of Psychology, Durham University , Durham, UK.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2020.1786036']
1791,32627599,A placebo-controlled trial to investigate the safety and efficacy of Penicillin G/Hydrocortisone in patients with ALS (PHALS trial).,"Objective :  A recent case-series described patients with ALS to improve and/or stabilize after treatment with intravenous high-dose Penicillin G/Hydrocortisone (PenGH). In this study, we determine the safety and efficacy of intravenous PenGH versus placebo in combination with riluzole in patients with ALS. Methods :  Patients diagnosed with ALS according to the El Escorial criteria were randomized double-blind to four quarterly cycles of 21 d of intravenous PenGH or placebo in a 5:3 ratio. The primary outcome was change from baseline to week 48 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). Secondary outcomes were lung function, muscle strength, plasma creatinine, clinical stage, gastrostomy placement, quality of life and occurrence of adverse of events. Results :  In total, 16 patients were randomized (10 PenGH and 6 placebo), of which 6 (40%) completed the study. Patients treated with PenGH progressed with 2.2 (95% CI 1.1-3.3) ALSFRS-R points per month and PenGH treatment did not halt disease progression ( p  = 0.002). No significant differences were found between PenGH or placebo (mean difference 0.5, 95% CI -1.01 to ∞,  p  = 0.28). Although PenGH was well-tolerated, 6 patients (38%, 3 in each arm) had thrombotic complications due to the intravenous administration method. Conclusions :  Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo. Prolonged intravenous administration therapies may inflate thrombosis risk.",2020,Conclusions :  Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo.,"['16 patients were randomized (10 PenGH and 6', 'Patients diagnosed with ALS according to the El Escorial criteria', 'patients with ALS (PHALS trial', 'patients with ALS']","['riluzole', 'Penicillin G/Hydrocortisone (PenGH', 'Penicillin G/Hydrocortisone', 'intravenous PenGH or placebo', 'PenGH', 'intravenous PenGH versus placebo', 'placebo']","['disease progression', 'lung function, muscle strength, plasma creatinine, clinical stage, gastrostomy placement, quality of life and occurrence of adverse of events', 'safety and efficacy', 'change from baseline to week 48 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R', 'thrombotic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0030827', 'cui_str': 'Penicillin G'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",16.0,0.607565,Conclusions :  Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Van Es', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Ruben P A', 'Initials': 'RPA', 'LastName': 'Van Eijk', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Tommy M', 'Initials': 'TM', 'LastName': 'Bunte', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Van Den Berg', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2020.1788093']
1792,32627605,"Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial.","Cancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivation, however, few studies presented the effects of Cheonwangbosimdan on cancer-related insomnia. The purpose of study is to examine the feasibility of Cheonwangbosimdan treatments for cancer patients. Twenty-two participants were allocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number. The intervention group took Cheonwangbosimdan liquid once in a day and attend visits once a week for 4 weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4 weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) from baseline to the end of the trial. Responses to the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were secondary outcomes used to evaluate the quality of sleep. Outcomes were measured at a follow-up visit (visit 5) in the fifth week of the trial. There is no difference between 2 groups, but both groups showed tendency to alleviate cancer insomnia symptoms. SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score. The study can contribute to more attentive care for insomnia in cancer patients.",2020,"SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score.","['cancer patients', 'Cancer Patients', 'Cancer patients']","['Cheonwangbosimdan', 'Cheonwangbosimdan (Tian Wang Bu Xin Dan', 'Cheonwangbosimdan liquid', 'Cognitive-Behavioral Therapy', 'Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number', 'individualized behavioral therapy']","['quality of sleep', 'Insomnia Severity Index (ISI', 'Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS', 'alleviate cancer insomnia symptoms']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",22.0,0.0309818,"SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score.","[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Moon', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ui Min', 'Initials': 'UM', 'LastName': 'Jerng', 'Affiliation': 'Sang-ji University Korean Medicine Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'O-Jin', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jee Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Woo', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Chul', 'Initials': 'WC', 'LastName': 'Shin', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Ick', 'Initials': 'JI', 'LastName': 'Byun', 'Affiliation': 'Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420935643']
1793,32627621,Comparison of different methods of patient education on preeclampsia: a randomized controlled trial.,"BACKGROUND


Preeclampsia is a life-threatening condition unique to pregnancy that contributes to maternal mortality worldwide. Delays in diagnosis and treatment are contributing factors for most maternal deaths from preeclampsia. Patients who are educated and knowledgeable regarding this disease process may present earlier for care.
OBJECTIVE


To assess whether two different visual aids are effective methods to educate patients about preeclampsia, and to evaluate the potential impact of these visual aids on patient anxiety.
STUDY DESIGN


Primigravid participants at a tertiary care center were given a survey regarding preeclampsia knowledge 18-25 weeks gestation. Participants were then randomized to preeclampsia education with a graphic card, an educational video, or through routine prenatal care. Participants completed the survey again at 32-37 weeks gestation. We compared the follow-up preeclampsia knowledge score for each type of education as well as the level of anxiety after viewing the video or graphic card.
RESULTS


Recruitment began 9 May 2016 and ceased 18 January 2017. A total of 179 patients were randomized and 150 participants completed the study, with 56 shown the graphic card, 45 shown the educational video, and 49 who had only routine prenatal counseling. The remaining 28 patients were lost to follow up and 1 was withdrawn. There was no significant difference in preeclampsia knowledge score at follow-up. There was no significant difference in anxiety score before and after viewing either educational tool for those randomized to either the graphic card ( p  = .64) or the video ( p  = .63).
CONCLUSIONS


There is no additional improvement of patient knowledge retention when patients receive education with a graphic card versus an educational video over routine prenatal counseling. Patient anxiety does not appear to be impacted by preeclampsia education with a graphic card or an educational video.",2020,"There was no significant difference in anxiety score before and after viewing either educational tool for those randomized to either the graphic card ( p  = .64) or the video ( p  = .63).
","['179 patients were randomized and 150 participants completed the study, with 56 shown the graphic card, 45 shown the educational video, and 49 who had only routine prenatal counseling', 'patient education on preeclampsia', 'Primigravid participants at a tertiary care center were given a survey regarding preeclampsia knowledge 18-25\u2009weeks gestation']","['graphic card, an educational video, or through routine prenatal care', 'graphic card versus an educational video over routine prenatal counseling']","['preeclampsia knowledge score', 'patient knowledge retention', 'anxiety score']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",179.0,0.122134,"There was no significant difference in anxiety score before and after viewing either educational tool for those randomized to either the graphic card ( p  = .64) or the video ( p  = .63).
","[{'ForeName': 'Emmie R', 'Initials': 'ER', 'LastName': 'Strassberg', 'Affiliation': 'Department of Maternal-Fetal Medicine, Geisinger, Danville, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Department of Maternal-Fetal Medicine, Geisinger, Danville, PA, USA.'}, {'ForeName': 'A Dhanya', 'Initials': 'AD', 'LastName': 'Mackeen', 'Affiliation': 'Department of Maternal-Fetal Medicine, Geisinger, Danville, PA, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Biostatistics Core, Geisinger, Danville, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Paglia', 'Affiliation': 'Department of Maternal-Fetal Medicine, Geisinger, Danville, PA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1786524']
1794,32627646,Self-Persuasion: An Experimental Evaluation of a Sexual Aggression Preventive Intervention for U.S. College Men.,"Grounded in the self-persuasion paradigm (an indirect persuasion approach, which places people in situations that motivate them to change their behavior), this study evaluated a brief, online intervention to reduce sexual aggression perpetration and increase prosocial bystander behaviors among heterosexual male college students ( N  = 241) in the United States. Students were randomly assigned to three conditions: (a) a self-persuasion intervention, (b) a social norms control condition, and (c) a control condition focusing on sense of belongingness. The self-persuasion intervention integrated three social psychological theoretical perspectives on attitudinal and behavioral change-cognitive dissonance (e.g., creating a personalized video message for incoming male college freshmen to explain the importance of consent in sexual contact), self-affirmation (e.g., reflecting on one's core values and how they are congruent with sexual consent), and personal relevance (e.g., writing about personally relevant reasons to always seek consent when having sexual contact). Participants in the self-persuasion condition reported greater prosocial bystander behaviors (e.g., intervening in situations to prevent sexual aggression) 6 months after the intervention as compared with those in the other two conditions; however, there were no significant difference in the rate of self-reported sexual aggression perpetration across conditions. The positive effect of the self-persuasion intervention on prosocial bystander behaviors was mediated by reduced self-perceived likelihood to commit sexual aggression and moderated by in-group solidarity with other college students. That is, the intervention had the most positive effect on prosocial bystander behaviors among participants with a lower sense of in-group solidarity. These findings are discussed in light of the promise of self-persuasion for future sexual aggression prevention work.",2020,The positive effect of the self-persuasion intervention on prosocial bystander behaviors was mediated by reduced self-perceived likelihood to commit sexual aggression and moderated by in-group solidarity with other college students.,"['U.S. College Men', 'heterosexual male college students ( N  = 241) in the United States']","['self-persuasion intervention, (b) a social norms control condition, and (c) a control condition focusing on sense of belongingness', 'Self-Persuasion', 'self-persuasion intervention', 'Sexual Aggression Preventive Intervention']","['prosocial bystander behaviors', 'rate of self-reported sexual aggression perpetration']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}]",,0.0222667,The positive effect of the self-persuasion intervention on prosocial bystander behaviors was mediated by reduced self-perceived likelihood to commit sexual aggression and moderated by in-group solidarity with other college students.,"[{'ForeName': 'Y Joel', 'Initials': 'YJ', 'LastName': 'Wong', 'Affiliation': 'Indiana University Bloomington, USA.'}, {'ForeName': 'Ryon C', 'Initials': 'RC', 'LastName': 'McDermott', 'Affiliation': 'University of South Alabama, Mobile, USA.'}, {'ForeName': 'Nelson O O', 'Initials': 'NOO', 'LastName': 'Zounlome', 'Affiliation': 'Indiana University Bloomington, USA.'}, {'ForeName': 'Elyssa M', 'Initials': 'EM', 'LastName': 'Klann', 'Affiliation': 'Indiana University Bloomington, USA.'}, {'ForeName': 'Zoë D', 'Initials': 'ZD', 'LastName': 'Peterson', 'Affiliation': 'Indiana University Bloomington, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520936369']
1795,32627683,Does the Initial Level of Horizontal Force Determine the Magnitude of Improvement in Acceleration Performance in Rugby?,"This study aimed to observe the effect of 8 weeks of resisted sled training (RST), with optimal loading for maximal power output production and initial levels of force, on the magnitude of improvement in sprint performance and individual sprint mechanical outputs in female amateur rugby union players. The study examined the horizontal Power-Force-Velocity profile (P-F-V profile), which provides a measure of the athlete's individual balance between force and velocity capabilities (S fv ), theoretical maximum force (F 0 ), theoretical maximum velocity (V 0 ), maximum power (P max ), the maximum ratio of force (Rf max ) and rate of decrease in ratio of force (D rf ). Thirty-one participants (age=23.7 ± 3.3years, BM=69 ± 9Kg, height=167.5 ± 5.2 cm) were divided into a control group and two experimental groups; forwards (FG) and backs (BG). For 8 consecutive weeks (16 sessions), all groups performed the same training program: 2 sets of 5 × 30 m, but athletes assigned to FG and BG ran towing a resisted sled attached to their waists, with optimal loading for maximal power output production. Both FG and BG significantly improved (p≤0.05) in 5 m and 20 m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile. The correlation between the initial level of horizontal strength and the magnitude of improvement in P max  also suggests that higher levels of horizontal force may lead to greater adaptations in RST. The P-F-V profile is a useful field method for identifying the weakest mechanical variable in rugby players during sprinting and enabling the prescription of individualized training programs according to specific running performance.",2020,"Both FG and BG significantly improved (p≤0.05) in 5 m and 20 m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile.","['Thirty-one participants (age=23.7\u2009±\u20093.3years, BM=69\u2009±\u20099Kg, height=167.5\u2009±\u20095.2\u2005cm', 'female amateur rugby union players']","['resisted sled training (RST', 'FG and BG ran towing a resisted sled attached to their waists, with optimal loading for maximal power output production']","['velocity capabilities (S fv ), theoretical maximum force (F 0 ), theoretical maximum velocity (V 0 ), maximum power (P max ), the maximum ratio of force (Rf max ) and rate of decrease in ratio of force (D rf ', 'horizontal Power-Force-Velocity profile']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0336980', 'cui_str': 'Sledding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",31.0,0.0231945,"Both FG and BG significantly improved (p≤0.05) in 5 m and 20 m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile.","[{'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Escobar', 'Affiliation': 'PhD Candidate in Sport Science, Faculty of Higher Education, South Essex College University Centre, Southend on the Sea, United Kingdom.'}, {'ForeName': 'Pedro Jiménez Reyes', 'Initials': 'PJR', 'LastName': 'Álvarez', 'Affiliation': 'PhD in Sport Science, Centre for Sports Studies, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Filipe Almeida', 'Initials': 'FA', 'LastName': 'Da Conceição', 'Affiliation': 'PhD in Sport Science, Centro Inovação Formação Investigação em Desporto, Faculdade Desporto, Porto Portugal.'}, {'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Fuentes García', 'Affiliation': 'PhD in Sport Science, Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1793004']
1796,32627803,Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial.,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.",2020,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","['Nigeria', '60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring']",['community health worker support and home monitoring'],"['blood pressure control', 'systolic blood pressure']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",60.0,0.0620388,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","[{'ForeName': 'Dike B', 'Initials': 'DB', 'LastName': 'Ojji', 'Affiliation': 'Cardiology Unit, Department of Medicine, College of Health Sciences, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria. Email: dike.ojji@uniabuja,edu,ng.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Baldridge', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Orji', 'Affiliation': 'Disease Control Unit, Department of Health, Abuja Municipal Area Council, Federal Capital Territory, Nigeria.'}, {'ForeName': 'Lamkur G', 'Initials': 'LG', 'LastName': 'Shedul', 'Affiliation': 'Department of Family Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Olubunmi I', 'Initials': 'OI', 'LastName': 'Ojji', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Nonye B', 'Initials': 'NB', 'LastName': 'Egenti', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Ada M', 'Initials': 'AM', 'LastName': 'Nwankwo', 'Affiliation': 'Department of Community Medicine, College of Health Sciences University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-066']
1797,32627812,Systemic arterial hypertension and cognition in adults: effects on executive functioning.,"BACKGROUND


Central nervous system changes associated to systemic arterial hypertension (SAH) are progressive and may cause negative effects on cognitive performance. The objective of this study was to investigate the relation between SAH and the components of executive functions (EF), inhibitory control (IC), updating and shifting, comparing a control group (without SAH) to patients with SAH, in two levels of severity.
METHODS


The protocol included the following tests to evaluate EF components: T.O.V.A. Test (IC), Backward Digit Span from Wechsler Adults Intelligence Scale (WAIS-III), Phonemic and Semantic Verbal Fluency (updating), and Trail Making Test Part B (shifting).
RESULTS


A total of 204 participants was included: 56 from the Control Group (CG), 87 SAH stage 1, and 61 SAH stage 2. The groups were not different for age (52.37±12.29) and education (10.98±4.06). As to controlled blood pressure (BP), duration of hypertension treatment and number of drugs, the SAH 2 group had a worse BP control, longer duration of hypertension treatment and use of more drugs when compared to the SAH 1. The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
CONCLUSION


The results suggest that patients with SAH have a significant impairment in EF, more specifically in updating and shifting. Besides that, such damage may be directly proportional to the severity of SAH. It is suggested that future studies include neuroimaging exams to exclude possible cerebrovascular diseases.",2020,"The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
","['patients with SAH, in two levels of severity', 'patients with SAH', 'adults', '204 participants was included: 56 from the Control Group (CG), 87 SAH stage 1, and 61 SAH stage 2']",[],"['Test (IC), Backward Digit Span from Wechsler Adults Intelligence Scale (WAIS-III), Phonemic and Semantic Verbal Fluency (updating), and Trail Making Test Part B (shifting', 'controlled blood pressure (BP), duration of hypertension treatment and number of drugs', 'executive functions (EF), inhibitory control (IC), updating and shifting', 'performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B', 'Systemic arterial hypertension and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]",[],"[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",204.0,0.0402133,"The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
","[{'ForeName': 'Natália Cristina', 'Initials': 'NC', 'LastName': 'Moraes', 'Affiliation': 'Universidade de São Paulo, Department of Neurology, São Paulo SP, Brazil.'}, {'ForeName': 'Henrique Cotchi Simbo', 'Initials': 'HCS', 'LastName': 'Muela', 'Affiliation': 'Universidade Agostinho Neto, Faculty of Medicine, Department of Physiology, Luanda, Angola.'}, {'ForeName': 'Claudia Maia', 'Initials': 'CM', 'LastName': 'MemÓria', 'Affiliation': 'Universidade de São Paulo, Department of Neurology, São Paulo SP, Brazil.'}, {'ForeName': 'Valéria Aparecida da', 'Initials': 'VAD', 'LastName': 'Costa-Hong', 'Affiliation': 'Universidade de São Paulo, Hypertension Unit, Heart Institute, São Paulo SP, Brazil.'}, {'ForeName': 'Michel Ferreira', 'Initials': 'MF', 'LastName': 'Machado', 'Affiliation': 'Universidade de São Paulo, Hypertension Unit, Heart Institute, São Paulo SP, Brazil.'}, {'ForeName': 'Mario Amore', 'Initials': 'MA', 'LastName': 'Cechinhi', 'Affiliation': 'Universidade de São Paulo, Department of Neurology, São Paulo SP, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Nitrini', 'Affiliation': 'Universidade de São Paulo, Department of Neurology, São Paulo SP, Brazil.'}, {'ForeName': 'Luiz Aparecido', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Universidade de São Paulo, Hypertension Unit, Heart Institute, São Paulo SP, Brazil.'}, {'ForeName': 'Monica Sanches', 'Initials': 'MS', 'LastName': 'Yassuda', 'Affiliation': 'Universidade de São Paulo, Department of Neurology, São Paulo SP, Brazil.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282X20200039']
1798,32627859,Information fraction estimation based on the number of events within the standard treatment regimen.,"For a Phase III randomized trial that compares survival outcomes between an experimental treatment versus a standard therapy, interim monitoring analysis is used to potentially terminate the study early based on efficacy. To preserve the nominal Type I error rate, alpha spending methods and information fractions are used to compute appropriate rejection boundaries in studies with planned interim analyses. For a one-sided trial design applied to a scenario in which the experimental therapy is superior to the standard therapy, interim monitoring should provide the opportunity to stop the trial prior to full follow-up and conclude that the experimental therapy is superior. This paper proposes a method called total control only (TCO) for estimating the information fraction based on the number of events within the standard treatment regimen. Based on theoretical derivations and simulation studies, for a maximum duration superiority design, the TCO method is not influenced by departure from the designed hazard ratio, is sensitive to detecting treatment differences, and preserves the Type I error rate compared to information fraction estimation methods that are based on total observed events. The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage. For these reasons, the TCO method is a good approach when designing a maximum duration superiority trial with planned interim monitoring analyses.",2020,"The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage.",[],[],[],[],[],[],,0.0244162,"The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage.","[{'ForeName': 'Ha M', 'Initials': 'HM', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Alonzo', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sandrah P', 'Initials': 'SP', 'LastName': 'Eckel', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Biometrical journal. Biometrische Zeitschrift,['10.1002/bimj.201900236']
1799,32627890,"Impaired pulmonary gas exchange efficiency, but normal pulmonary artery pressure increases with hypoxia in men and women with a patent foramen ovale.","NEW FINDINGS


What is the central question of this study? Whether or not individuals with a patent foramen ovale (PFO+) have a larger alveolar-to-arterial difference in PO 2  (A-aDO 2  ) than those without (PFO-) and/or an exaggerated increase in pulmonary artery systolic pressure (PASP) in response to hypoxia. What is the main finding and its importance? PFO+ had a greater A-aDO 2  while breathing air, 16% and 14%, but not 12% or 10% O 2  . PASP increased equally in hypoxia between PFO+ and PFO-. These data suggest that PFO+ may not have an exaggerated acute increase in PASP in response to hypoxia.
ABSTRACT


Patent foramen ovale (PFO) is present in 30-40% of the population and is a potential source of right-to-left shunt. Accordingly, those with a PFO (PFO+) may have a larger alveolar-to-arterial difference in PO 2  (A-aDO 2  ) than those without (PFO-) in normoxia and with mild hypoxia. Likewise, PFO is associated with high-altitude pulmonary oedema, a condition known to have an exaggerated pulmonary pressure response to hypoxia. Thus, PFO+ may also have exaggerated pulmonary pressure increases in response to hypoxia. Therefore, the purposes of the present study were to systematically determine whether or not: 1) the A-aDO 2  was greater in PFO+ than PFO- in normoxia and mild to severe hypoxia and 2) the increase in pulmonary artery systolic pressure (PASP) in response to hypoxia was greater in PFO+ than PFO-. We measured arterial blood gases and PASP via ultrasound in healthy PFO+ (n = 15) and PFO- (n = 15) humans breathing air and 30-minutes after breathing 4 levels of hypoxia (16, 14, 12, 10% O 2  , randomized and balanced order) at rest. The A-aDO 2  was significantly greater in PFO+ compared to PFO- while breathing air (2.1 ± 0.7 vs. 0.4 ± 0.3 Torr), 16% (1.8 ± 1.2 vs. 0.7 ± 0.8 Torr), and 14% (2.3 ± 1.2 vs. 0.7 ± 0.6 Torr), but not 12% or 10% O 2  . We found no effect of PFO on PASP at any level of hypoxia. We conclude that PFO influences pulmonary gas exchange efficiency with mild hypoxia, but not the acute increase in PASP in response to hypoxia. This article is protected by copyright. All rights reserved.",2020,"PFO+ had a greater A-aDO 2  while breathing air, 16% and 14%, but not 12% or 10% O 2  .","['n\xa0=\xa015', 'men and women with a patent foramen ovale', 'individuals with a patent foramen ovale (PFO', 'healthy PFO+ (n\xa0=\xa015) and PFO']","['PFO (PFO', 'PFO', 'PASP']","['pulmonary artery systolic pressure (PASP', 'normal pulmonary artery pressure increases with hypoxia', 'arterial blood gases and PASP via ultrasound', 'PFO']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}]","[{'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.0249063,"PFO+ had a greater A-aDO 2  while breathing air, 16% and 14%, but not 12% or 10% O 2  .","[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Duke', 'Affiliation': 'Northern Arizona University, Department of Biological Sciences, Flagstaff, AZ, USA.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Beasley', 'Affiliation': 'University of Oregon, Department of Human Physiology, Eugene, OR, USA.'}, {'ForeName': 'Julia P', 'Initials': 'JP', 'LastName': 'Speros', 'Affiliation': 'University of Oregon, Department of Human Physiology, Eugene, OR, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Elliott', 'Affiliation': 'VA Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Laurie', 'Affiliation': 'KBR, Cardiovascular and Vision Laboratory, NASA Johnson Space Center, Houston, TX, USA.'}, {'ForeName': 'Randall D', 'Initials': 'RD', 'LastName': 'Goodman', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Eben', 'Initials': 'E', 'LastName': 'Futral', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Jerold A', 'Initials': 'JA', 'LastName': 'Hawn', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Lovering', 'Affiliation': 'University of Oregon, Department of Human Physiology, Eugene, OR, USA.'}]",Experimental physiology,['10.1113/EP088750']
1800,32627952,Exercise Training Alters Red Blood Cell Fatty Acid Desaturase Indices and Adipose Tissue Fatty Acid Profile in African Women with Obesity.,"OBJECTIVE


This study assessed the changes in red blood cell total phospholipid (RBC-TPL) and subcutaneous adipose tissue (SAT) fatty acid (FA) composition in response to 12 weeks of exercise training in South African women with obesity and the associations with changes in cardiometabolic risk factors.
METHODS


Previously sedentary women were randomized into control (n = 15) or exercise (n = 20) groups. RBC-TPL and SAT FA profiles, SAT gene expression, systemic inflammatory markers, liver fat, and insulin sensitivity (S I  ) were measured before and after the intervention.
RESULTS


Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05). In the combined group, these changes correlated with changes in circulating leptin and TNFα (P < 0.05), as well as lower liver fat (P < 0.01). Exercise training decreased saturated FA (lauric and myristic acids) and increased polyunsaturated FA (eicosadienoic and adrenic acids) (P < 0.05) in abdominal SAT, whereas γ-linolenic acid decreased (P < 0.01) in gluteal SAT. These changes in RBC-TPL and SAT FA compositions were not associated with changes in SAT gene expression and S I  .
CONCLUSIONS


Exercise training alters RBC-TPL desaturase activities, which correlate with lower liver fat and systemic inflammation but not with the improvement of S I  .",2020,"Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05).","['South African women with obesity and the associations with changes in cardiometabolic risk factors', 'Previously sedentary women', 'African Women with Obesity']","['exercise training', 'Exercise Training', 'Exercise training', 'control, exercise training']","['saturated FA (lauric and myristic acids) and increased polyunsaturated FA (eicosadienoic and adrenic acids', 'RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity', 'RBC-TPL and SAT FA profiles, SAT gene expression, systemic inflammatory markers, liver fat, and insulin sensitivity (S I  ', 'RBC-TPL desaturase activities', 'lower liver fat and systemic inflammation', 'lower liver fat', 'circulating leptin and TNFα', 'γ-linolenic acid', 'red blood cell total phospholipid (RBC-TPL) and subcutaneous adipose tissue (SAT) fatty acid (FA) composition', 'RBC-TPL and SAT FA compositions']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0027138', 'cui_str': 'Myristic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1168488', 'cui_str': 'Total phospholipids'}, {'cui': 'C0000658', 'cui_str': '8,11,14-eicosatrienoic acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0190263,"Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05).","[{'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Nono Nankam', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'van Jaarsveld', 'Affiliation': 'Non-communicable Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melony C', 'Initials': 'MC', 'LastName': 'Fortuin-de Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Endocrinology, Faculty of Medicine, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22862']
1801,32627975,Effect of Chin-down-plus-larynx-tightening maneuver on swallowing function after minimally invasive esophagectomy: A randomized controlled trail.,"BACKGROUND


The incidence of swallowing abnormality was high after minimally invasive esophagectomy (MIE) for esophageal cancer (EC). Few reports, however, focused on interventions for dysphagia after esophagectomy.
AIM


The purpose of this research was to estimate the effect of Chin-down-plus-larynx-tightening maneuver on swallowing function for patients receiving esophagectomy.
METHOD


This was a 2-arm, parallel-group, single-blind randomized clinical trial, performed in patients suffered from EC from November 2018 to January 2020. Patients were randomly assigned to the intervention group (IG) or the control group (CG). The participants in CG received routine care, and the IG received Chin-down-plus-larynx-tightening maneuver during feeding. The incidence of choking cough, swallowing function, and dietary outcomes were evaluated before and after intervention for 7 days.
RESULTS


A total of 237 EC cases were enrolled and randomized to the IG (n = 118) or CG (n = 119). There was no significant difference between the two groups in terms of demographic and clinical characteristics. Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P < .001). The analysis showed that the participants in the IG compared with the CG have more total caloric intake of 24 hours and higher K/R (the ratio of calories oral achieved to total calories required of body) significantly from D1 to D7 of intervention (P < .05).
CONCLUSION


The findings suggest that the Chin-down-plus-larynx-tightening maneuver can improve swallowing function recovery and oral total food intake and calories in EC patients undergoing MIE.",2020,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","['patients receiving esophagectomy', 'A total of 237 EC cases', 'EC patients undergoing MIE', 'patients suffered from EC from November 2018 to January 2020', 'after minimally invasive esophagectomy']","['Chin-down-plus-larynx-tightening maneuver during feeding', 'Chin-down-plus-larynx-tightening maneuver', 'minimally invasive esophagectomy (MIE', 'CG', 'intervention group (IG) or the control group (CG']","['incidence of choking cough, swallowing function, and dietary outcomes', 'swallowing function', 'total caloric intake', 'Postoperative choking cough', 'swallowing function recovery and oral total food intake and calories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",237.0,0.0724695,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","[{'ForeName': 'Funa', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Peinan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xianben', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}]",Cancer medicine,['10.1002/cam4.3280']
1802,32628030,Leveraging goals to incentivize healthful behaviors across adulthood.,"Despite abundant evidence for the benefits of physical activity on aging trajectories, older Americans remain largely inactive. The present study was designed to examine age differences in responsiveness to financial incentives to increase walking. Grounded in socioemotional selectivity theory, we examined the effectiveness of financial incentives that varied in prosociality. Three types of incentives were presented to community-residing adults 18-92 years of age ( N  = 450). Participants were randomly assigned to 1 of 5 conditions: personal, loved one, charity, choice, or a no-incentive control group. Average daily step counts were measured using pedometers during a baseline week, during the incentivized period, and after the incentivized period ended. Overall, financial incentives significantly increased walking compared to a control group. Whereas personal incentives were effective regardless of age, incentives to earn for charities were starkly more effective in older adults than younger adults. Moreover, 1 week after the incentivized period ended, older participants were more likely to maintain increased step counts, whereas younger people reverted to baseline step counts. Findings suggest that financial incentives can increase walking in a wide age range and that charitable incentives may be especially effective in health interventions targeting older adults. The importance of aligning incentives with age-related goals is discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Overall, financial incentives significantly increased walking compared to a control group.","['Three types of incentives were presented to community-residing adults 18-92 years of age ( N  = 450', 'older adults than younger adults']","['5 conditions: personal, loved one, charity, choice, or a no-incentive control group']",['Average daily step counts'],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.0370805,"Overall, financial incentives significantly increased walking compared to a control group.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raposo', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Candice L', 'Initials': 'CL', 'LastName': 'Hogan', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Jessica T', 'Initials': 'JT', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Teja', 'Initials': 'T', 'LastName': 'Chemudupati', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Carstensen', 'Affiliation': 'Department of Psychology, Stanford University.'}]",Psychology and aging,['10.1037/pag0000428']
1803,32628115,Evaluation of Adaptive Feedback in a Smartphone-Based Game on Health Care Providers' Learning Gain: Randomized Controlled Trial.,"BACKGROUND


Although smartphone-based emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented, and its current implementation modes tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with gamified approaches remains largely unexplored, despite the lack of traditional training opportunities, and high mortality rates in these settings.
OBJECTIVE


The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency. A secondary aim is to examine the effects of learner characteristics and learning spacing with repeated use of the game on the secondary outcome of individualized normalized learning gain.
METHODS


The experiment is aimed at clinicians who provide bedside neonatal care in low-income settings. Data were captured through an Android app installed on the study participants' personal phones. The intervention, which was based on successful attempts at a learning task, included adaptive feedback provided within the app to the experimental arm, whereas the control arm received standardized feedback. The primary end point was completion of the second learning session. Of the 572 participants enrolled between February 2019 and July 2019, 247 (43.2%) reached the primary end point. The primary outcome was standardized relative change in learning gains between the study arms as measured by the Morris G effect size. The secondary outcomes were the participants individualized normalized learning gains.
RESULTS


The effect of adaptive feedback on care providers' learning gain was found to be g=0.09 (95% CI -0.31 to 0.46; P=.47). In exploratory analysis, using normalized learning gains, when subject-treatment interaction and differential time effect was controlled for, this effect increased significantly to 0.644 (95% CI 0.35 to 0.94; P<.001) with immediate repetition, which is a moderate learning effect, but reduced significantly by 0.28 after a week. The overall learning change from the app use in both arms was large and may have obscured a direct effect of feedback.
CONCLUSIONS


There is a considerable learning gain between the first two rounds of learning with both forms of feedback and a small added benefit of adaptive feedback after controlling for learner differences. We suggest that linking the adaptive feedback provided to care providers to how they space their repeat learning session(s) may yield higher learning gains. Future work might explore in more depth the feedback content, in particular whether or not explanatory feedback (why answers were wrong) enhances learning more than reflective feedback (information about what the right answers are).
TRIAL REGISTRATION


Pan African Clinical Trial Registry (PACTR) 201901783811130; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5836.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/13034.",2020,"The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency.","[""Health Care Providers' Learning Gain"", '572 participants enrolled between February 2019 and July 2019, 247 (43.2%) reached the primary end point']","['adaptive feedback', 'smartphone-based emergency care training']","['overall learning change', 'learning gain', ""care providers' learning gain"", 'completion of the second learning session', 'individualized normalized learning gains', 'standardized relative change in learning gains']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",572.0,0.0972468,"The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tuti', 'Affiliation': 'Kellogg College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Winters', 'Affiliation': 'Kellogg College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Edgcombe', 'Affiliation': 'Nuffield Division of Anaesthetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Muinga', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Wanyama', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17100']
1804,32628117,"Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study.","BACKGROUND


Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions.
OBJECTIVE


The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study.
METHODS


Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database.
RESULTS


Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users' unique exercise views were negatively correlated (r=-.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3.
CONCLUSIONS


These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user's self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.",2020,"Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043).","['Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of', 'After Breast Cancer Diagnosis', 'women newly diagnosed with breast cancer', 'patients with cancer']","['unguided web-based, psychoeducational distress self-management program CaringGuidance', 'CaringGuidance plus usual care versus usual care alone', 'Unguided, Web-Based Distress Self-Management Program']","['Mean logins', 'Change in depressive symptoms', 'frequency and activity level', ""number of users' unique exercise views""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449911', 'cui_str': 'View'}]",,0.0408537,"Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043).","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Lally', 'Affiliation': 'College of Nursing, Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Center for Computational Research, Roswell Park Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, United States.'}]",Journal of medical Internet research,['10.2196/19734']
1805,32628146,The ISCHEMIA trial: Implications for non-invasive imaging.,"Coronary artery disease (CAD) is highly prevalent and constitutes the single most common cause of death worldwide. However, the diagnosis of CAD remains challenging. There are two ways to approach the diagnosis of CAD, namely (1) by a functional non-invasive stress test to detect ischemia (stress echocardiography, stress cardiovascular magnetic resonance, single-photon emission computed tomography, positron emission tomography) or (2) by imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography). There are also two approaches for treatment: medical treatment and revascularization. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial investigated the outcome differences of patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50%. The patients were randomized to an initially conservative treatment versus immediate revascularization. No difference in hard outcomes was found, but angina relief was more effective in the revascularization group. In this article, we explore the implications of the ISCHEMIA trial for non-invasive testing in suspected CAD.",2020,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","['patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50']","['Medical and Invasive Approaches (ISCHEMIA', 'imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography', 'initially conservative treatment versus immediate revascularization']",['angina relief'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",,0.049503,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","[{'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Rakisheva', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Marwan', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}]",Anatolian journal of cardiology,['10.14744/AnatolJCardiol.2020.82428']
1806,32628250,Comparison of As-Needed and Scheduled Posthospitalization Follow-up for Children Hospitalized for Bronchiolitis: The Bronchiolitis Follow-up Intervention Trial (BeneFIT) Randomized Clinical Trial.,"Importance


Posthospitalization follow-up visits are prescribed frequently for children with bronchiolitis. The rationale for this practice is unclear, but prior work has indicated that families value these visits for the reassurance provided. The overall risks and benefits of scheduled visits have not been evaluated.
Objective


To assess whether an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing anxiety among parents of children hospitalized for bronchiolitis.
Design, Setting, and Participants


This open-label, noninferiority randomized clinical trial, performed between January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California). Data analysis was performed in an intention-to-treat manner.
Interventions


Randomization (1:1) to a scheduled (n = 151) vs an as-needed (n = 153) posthospitalization follow-up visit.
Main Outcome and Measures


The primary outcome was parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale, which ranged from 0 to 28 points, with higher scores indicating greater anxiety. Fourteen prespecified secondary outcomes were assessed.
Results


Among 304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88%). A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%). The mean (SD) 7-day parental anxiety score was 3.9 (3.5) among the as-needed posthospitalization follow-up group and 4.2 (3.5) among the scheduled group (absolute difference, -0.3 points; 95% CI, -1.0 to 0.4 points), with the upper bound of the 95% CI within the prespecified noninferiority margin of 1.1 points. Aside from a decreased mean number of clinic visits (absolute difference, -0.6 visits per patient; 95% CI, -0.4 to -0.8 visits per patient) among the as-needed group, there were no significant between-group differences in secondary outcomes, including readmissions (any hospital readmission before symptom resolution: absolute difference, -1.6%; 95% CI, -5.7% to 2.5%) and symptom duration (time from discharge to cough resolution: absolute difference, -0.6 days; 95% CI, -2.4 to 1.2 days; time from discharge to child reported ""back to normal"": absolute difference, -0.8 days; 95% CI, -2.7 to 1.0 days; and time from discharge to symptom resolution: absolute difference, -0.6 days; 95% CI, -2.5 to 1.3 days).
Conclusions and Relevance


Among parents of children hospitalized for bronchiolitis, an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing parental anxiety. These findings support as-needed follow-up as an effective posthospitalization follow-up strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03354325.",2020,"A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%).","['Children Hospitalized for Bronchiolitis', 'children with bronchiolitis', ""January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California"", 'parents of children hospitalized for bronchiolitis', '304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88']",[],"['mean number of clinic visits', 'parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale', 'anxiety', 'mean (SD) 7-day parental anxiety score', 'readmissions (any hospital readmission', 'symptom duration']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",304.0,0.180099,"A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%).","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Coon', 'Affiliation': ""Department of Pediatrics, Primary Children's Hospital, University of Utah School of Medicine, Salt Lake City.""}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Destino', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vukin', 'Affiliation': ""Department of Pediatrics, Primary Children's Hospital, University of Utah School of Medicine, Salt Lake City.""}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Stoddard', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schroeder', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.1937']
1807,32628258,Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial.,"Importance


Standardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.
Objective


To test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.
Design, Setting, and Participants


The Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.
Interventions


Five 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.
Main Outcomes and Measures


Twelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.
Results


The study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).
Conclusions and Relevance


This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02612688.",2020,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","['Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations', 'Long-Stay Nursing Home Residents', '4171 residents with advanced illness (21.9%) viewed ACP videos', '4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11\u202f773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years', 'Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11\u202f773 long-stay residents without advanced illness in the control group', 'long-stay residents with or without advanced illness', 'long-stay nursing home residents with and without advanced illness']","['advance care planning (ACP', 'Video Education', 'Advance Care Planning Video Intervention', 'ACP video program']","['proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment', 'hospital transfers, burdensome treatments, and hospice enrollment', 'hospital transfers', 'hospital transfers per 1000 person-days alive in the advanced illness cohort', 'Facility-level rates of showing ACP videos']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",4171.0,0.160497,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gozalo', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ruoshui', 'Initials': 'R', 'LastName': 'Zhai', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2366']
1808,32628266,Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial.,"Importance


The concept of embolic stroke of undetermined source (ESUS) unifies a subgroup of cryptogenic strokes based on neuroimaging, a defined minimum set of diagnostic tests, and exclusion of certain causes. Despite an annual stroke recurrence rate of 5%, little is known about the etiology underlying recurrent stroke after ESUS.
Objective


To identify the stroke subtype of recurrent ischemic strokes after ESUS, to explore the interaction with treatment assignment in each category, and to examine the consistency of cerebral location of qualifying ESUS and recurrent ischemic stroke.
Design, Setting, and Participants


The NAVIGATE-ESUS trial was a randomized clinical trial conducted from December 23, 2014, to October 5, 2017. The trial compared the efficacy and safety of rivaroxaban and aspirin in patients with recent ESUS (n = 7213). Ischemic stroke was validated in 309 of the 7213 patients by adjudicators blinded to treatment assignment and classified by local investigators into the categories ESUS or non-ESUS (ie, cardioembolic, atherosclerotic, lacunar, other determined cause, or insufficient testing). Five patients with recurrent strokes that could not be defined as ischemic or hemorrhagic in absence of neuroimaging or autopsy were excluded. Data for this secondary post hoc analysis were analyzed from March to June 2019.
Interventions


Patients were randomly assigned to receive rivaroxaban, 15 mg/d, or aspirin, 100 mg/d.
Main Outcomes and Measures


Association of recurrent ESUS with stroke characteristics.
Results


A total of 309 patients (205 men [66%]; mean [SD] age, 68 [10] years) had ischemic stroke identified during the median follow-up of 11 (interquartile range [IQR], 12) months (annualized rate, 4.6%). Diagnostic testing was insufficient for etiological classification in 39 patients (13%). Of 270 classifiable ischemic strokes, 156 (58%) were ESUS and 114 (42%) were non-ESUS (37 [32%] cardioembolic, 26 [23%] atherosclerotic, 35 [31%] lacunar, and 16 [14%] other determined cause). Atrial fibrillation was found in 27 patients (9%) with recurrent ischemic stroke and was associated with higher morbidity (median change in modified Rankin scale score 2 [IQR, 3] vs 0 (IQR, 1]) and mortality (15% vs 1%) than other causes. Risk of recurrence did not differ significantly by subtype between treatment groups. For both the qualifying and recurrent strokes, location of infarct was more often in the left (46% and 54%, respectively) than right hemisphere (40% and 37%, respectively) or brainstem or cerebellum (14% and 9%, respectively).
Conclusions and Relevance


In this secondary analysis of randomized clinical trial data, most recurrent strokes after ESUS were embolic and of undetermined source. Recurrences associated with atrial fibrillation were a minority but were more often disabling and fatal. More extensive investigation to identify the embolic source is important toward an effective antithrombotic strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02313909.",2020,Risk of recurrence did not differ significantly by subtype between treatment groups.,"['309 patients (205 men [66%]; mean [SD] age, 68 [10] years) had ischemic stroke identified during the median follow-up of 11 (interquartile range [IQR], 12) months (annualized rate, 4.6', 'patients with recent ESUS (n\u2009=\u20097213', '309 of the 7213 patients by adjudicators blinded to treatment assignment and classified by local investigators into the categories ESUS or non-ESUS (ie, cardioembolic, atherosclerotic, lacunar, other determined cause, or insufficient testing', '39 patients (13', 'After Embolic Stroke of Undetermined Source', 'Five patients with recurrent strokes']","['rivaroxaban', 'rivaroxaban and aspirin', 'aspirin']","['Risk of recurrence', 'Recurrences associated with atrial fibrillation', 'Atrial fibrillation', 'efficacy and safety', 'recurrent ischemic stroke', 'mortality', 'Recurrent Ischemic Stroke', 'higher morbidity', 'Ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0401783', 'cui_str': 'Adjudicator'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",5.0,0.199184,Risk of recurrence did not differ significantly by subtype between treatment groups.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'currently a biostatistics consultant, St Catharines, Ontario, Canada.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Korompoki', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Toni', 'Affiliation': 'Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Ameriso', 'Affiliation': 'Departamento de Neurología, Fleni, Buenos Aires, Argentina.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neurosciences and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Faculty of Health and Medical Sciences, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences and Neurology, Lund University, Lund, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer, LLC, Whippany, New Jersey.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia Manual Velasco Suarez, Mexico City, Mexico.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Department of Neuroscience, Hospital Clinic of Barcelona, Institute Reçerca Biomèdica August Pi i Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Department of Neuroscience, Hospital Clinic of Barcelona, Institute Reçerca Biomèdica August Pi i Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1995']
1809,32628293,Behavioural activation therapy for depression in adults.,"BACKGROUND


Behavioural activation is a brief psychotherapeutic approach that seeks to change the way a person interacts with their environment. Behavioural activation is increasingly receiving attention as a potentially cost-effective intervention for depression, which may require less resources and may be easier to deliver and implement than other types of psychotherapy.
OBJECTIVES


To examine the effects of behavioural activation compared with other psychological therapies for depression in adults. To examine the effects of behavioural activation compared with medication for depression in adults. To examine the effects of behavioural activation compared with treatment as usual/waiting list/placebo no treatment for depression in adults.
SEARCH METHODS


We searched CCMD-CTR (all available years), CENTRAL (current issue), Ovid MEDLINE (1946 onwards), Ovid EMBASE (1980 onwards), and Ovid PsycINFO (1806 onwards) on the 17 January 2020 to identify randomised controlled trials (RCTs) of 'behavioural activation', or the main elements of behavioural activation for depression in participants with clinically diagnosed depression or subthreshold depression. We did not apply any restrictions on date, language or publication status to the searches. We searched international trials registries via the World Health Organization's trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished or ongoing trials.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of behavioural activation for the treatment of depression or symptoms of depression in adults aged 18 or over. We excluded RCTs conducted in inpatient settings and with trial participants selected because of a physical comorbidity. Studies were included regardless of reported outcomes.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened all titles/abstracts and full-text manuscripts for inclusion. Data extraction and 'Risk of bias' assessments were also performed by two review authors in duplicate. Where necessary, we contacted study authors for more information.
MAIN RESULTS


Fifty-three studies with 5495 participants were included; 51 parallel group RCTs and two cluster-RCTs. We found moderate-certainty evidence that behavioural activation had greater short-term efficacy than treatment as usual (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.10 to 1.78; 7 RCTs, 1533 participants), although this difference was no longer evident in sensitivity analyses using a worst-case or intention-to-treat scenario. Compared with waiting list, behavioural activation may be more effective, but there were fewer data in this comparison and evidence was of low certainty (RR 2.14, 95% CI 0.90 to 5.09; 1 RCT, 26 participants). No evidence on treatment efficacy was available for behavioural activation versus placebo and behavioural activation versus no treatment. We found moderate-certainty evidence suggesting no evidence of a difference in short-term treatment efficacy between behavioural activation and CBT (RR 0.99, 95% CI 0.92 to 1.07; 5 RCTs, 601 participants). Fewer data were available for other comparators. No evidence of a difference in short term-efficacy was found between behavioural activation and third-wave CBT (RR 1.10, 95% CI 0.91 to 1.33; 2 RCTs, 98 participants; low certainty), and psychodynamic therapy (RR 1.21, 95% CI 0.74 to 1.99; 1 RCT,60 participants; very low certainty). Behavioural activation was more effective than humanistic therapy (RR 1.84, 95% CI 1.15 to 2.95; 2 RCTs, 46 participants; low certainty) and medication (RR 1.77, 95% CI 1.14 to 2.76; 1 RCT; 141 participants; moderate certainty), but both of these results were based on a small number of trials and participants. No evidence on treatment efficacy was available for comparisons between behavioural activation versus interpersonal, cognitive analytic, and integrative therapies. There was moderate-certainty evidence that behavioural activation might have lower treatment acceptability (based on dropout rate) than treatment as usual in the short term, although the data did not confirm a difference and results lacked precision (RR 1.64, 95% CI 0.81 to 3.31; 14 RCTs, 2518 participants). Moderate-certainty evidence did not suggest any difference in short-term acceptability between behavioural activation and waiting list (RR 1.17, 95% CI 0.70 to 1.93; 8 RCTs. 359 participants), no treatment (RR 0.97, 95% CI 0.45 to 2.09; 3 RCTs, 187 participants), medication (RR 0.52, 95% CI 0.23 to 1.16; 2 RCTs, 243 participants), or placebo (RR 0.72, 95% CI 0.31 to 1.67; 1 RCT; 96 participants; low-certainty evidence). No evidence on treatment acceptability was available comparing behavioural activation versus psychodynamic therapy. Low-certainty evidence did not show a difference in short-term treatment acceptability (dropout rate) between behavioural activation and CBT (RR 1.03, 95% CI 0.85 to 1.25; 12 RCTs, 1195 participants), third-wave CBT (RR 0.84, 95% CI 0.33 to 2.10; 3 RCTs, 147 participants); humanistic therapy (RR 1.06, 95% CI 0.20 to 5.55; 2 RCTs, 96 participants) (very low certainty), and interpersonal, cognitive analytic, and integrative therapy (RR 0.84, 95% CI 0.32 to 2.20; 4 RCTs, 123 participants). Results from medium- and long-term primary outcomes, secondary outcomes, subgroup analyses, and sensitivity analyses are summarised in the text.
AUTHORS' CONCLUSIONS


This systematic review suggests that behavioural activation may be more effective than humanistic therapy, medication, and treatment as usual, and that it may be no less effective than CBT, psychodynamic therapy, or being placed on a waiting list. However, our confidence in these findings is limited due to concerns about the certainty of the evidence. We found no evidence of a difference in short-term treatment acceptability (based on dropouts) between behavioural activation and most comparison groups (CBT, humanistic therapy, waiting list, placebo, medication, no treatment or treatment as usual). Again, our confidence in all these findings is limited due to concerns about the certainty of the evidence. No data were available about the efficacy of behaioural activation compared with placebo, or about treatment acceptability comparing behavioural activation and psychodynamic therapy, interpersonal, cognitive analytic and integrative therapies. The evidence could be strengthened by better reporting and better quality RCTs of behavioural activation and by assessing working mechanisms of behavioural activation.",2020,"No evidence of a difference in short term-efficacy was found between behavioural activation and third-wave CBT (RR 1.10, 95% CI 0.91 to 1.33; 2 RCTs, 98 participants; low certainty), and psychodynamic therapy (RR 1.21, 95% CI 0.74 to 1.99; 1 RCT,60 participants; very low certainty).","['participants with clinically diagnosed depression or subthreshold depression', '1980 onwards), and Ovid PsycINFO (1806 onwards) on the 17 January 2020', 'Fifty-three studies with 5495 participants were included; 51 parallel group RCTs and two cluster-RCTs', 'adults', 'depression in adults', 'depression or symptoms of depression in adults aged 18 or over']","['Behavioural activation therapy', 'behavioural activation', 'Ovid EMBASE ', 'placebo']","['usual (risk ratio (RR', 'behavioural activation and waiting list', 'short term-efficacy', 'Behavioural activation']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",5495.0,0.306503,"No evidence of a difference in short term-efficacy was found between behavioural activation and third-wave CBT (RR 1.10, 95% CI 0.91 to 1.33; 2 RCTs, 98 participants; low certainty), and psychodynamic therapy (RR 1.21, 95% CI 0.74 to 1.99; 1 RCT,60 participants; very low certainty).","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Uphoff', 'Affiliation': 'Cochrane Common Mental Disorders, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ekers', 'Affiliation': 'Lanchester Road Hospital, Tees, Esk and Wear Valleys NHS Foundation Trust, Durham, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Robertson', 'Affiliation': 'Cochrane Common Mental Disorders, University of York, York, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawson', 'Affiliation': 'Cochrane Common Mental Disorders, University of York, York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanger', 'Affiliation': 'Cochrane Common Mental Disorders, University of York, York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'South', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Samaan', 'Affiliation': 'Psychiatry, Faculty of Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'School of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Meader', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Churchill', 'Affiliation': 'Cochrane Common Mental Disorders, University of York, York, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013305.pub2']
1810,31814431,Effects of Kinesio tape application to trunk isokinetic strength in female participants.,"The purpose of this study is to analyse the effects of KT on trunk strength with respect to different angular speeds when applied to the trunks of healthy women. Forty healthy female participants were randomly distributed into two groups: the placebo group (PG) in which placebo KT was applied and the experimental group (EG). Participants' trunk concentric flexion and extension muscle strength were measured using an isokinetic dynamometer in two different angular speeds (60°/s - 180°/s). In both PG and EG groups, there was no significant difference measured immediately after taping at the two angular speed values. In the measurements taken 48 h later, as regards PG trunk flexion, extension muscle strength increased significantly (p = 0.0001) at 60°/sc. angular speed while, for the EG only, the strength of trunk extension muscle increased significantly (p = 0.002). It was observed, that to ensure an increase in strength, waiting for a certain length of time was required. Lower angular speeds and short-term applied KT improved the strength of the trunk extension muscle.",2020,"In both PG and EG groups, there was no significant difference measured immediately after taping at the two angular speed values.","[' 180°', 'healthy women', 'Forty healthy female participants', 'female participants']","['placebo group (PG) in which placebo KT', 'Kinesio tape application', 'KT']","['trunk concentric flexion and extension muscle strength', 'trunk isokinetic strength', 'strength, waiting for a certain length of time', 'strength of the trunk extension muscle', 'strength of trunk extension muscle', 'PG trunk flexion, extension muscle strength']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",40.0,0.0204654,"In both PG and EG groups, there was no significant difference measured immediately after taping at the two angular speed values.","[{'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Buke', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University , Denizli, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Unver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University , Denizli, Turkey.'}]",Research in sports medicine (Print),['10.1080/15438627.2019.1699796']
1811,32622394,"Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial.","BACKGROUND


Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.
METHODS


In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.
FINDINGS


Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.
INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.
FUNDING


UK National Institute for Health Research.",2020,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","['Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis', '110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm', '776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119', 'primary spontaneous pneumothorax', 'adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years', 'otherwise healthy young patients']","['ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both', 'ambulatory management compared with standard care']","['duration of hospitalisation including re-admissions', 'total length of hospital stay including re-admission', 'adverse events', 'median hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.148264,"INTERPRETATION


Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","[{'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Hallifax', 'Affiliation': 'Oxford Centre for Respiratory Medicine, University of Oxford, Oxford, UK. Electronic address: robert.hallifax@ndm.ox.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McKeown', 'Affiliation': 'Royal Berkshire National Health Service (NHS) Foundation Trust, Reading, UK.'}, {'ForeName': 'Parthipan', 'Initials': 'P', 'LastName': 'Sivakumar', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fairbairn', 'Affiliation': 'Queen Margaret Hospital, NHS Fife, Dunfermline, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leitch', 'Affiliation': 'Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stanton', 'Affiliation': 'Great Western Hospital NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amrithraj', 'Initials': 'A', 'LastName': 'Bhatta', 'Affiliation': 'Blackpool Fylde and Wyre Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Kettering General Hospital, Kettering, UK.'}, {'ForeName': 'Marie-Clare', 'Initials': 'MC', 'LastName': 'Harris', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Maddekar', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corcoran', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31043-6']
1812,32622397,Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial.,"BACKGROUND


Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction.
METHODS


In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389.
FINDINGS


Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means -3·12, 95% CI -5·79 to -0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, -0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication.
INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","['men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction', 'Between July 23, 2014, and Dec 30, 2016, 410 men', 'men with lower urinary tract symptoms or urinary retention (UNBLOCS', 'men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction']","['TURP', 'ThuVARP technique', 'ThuVARP', 'Thulium laser transurethral vaporesection of the prostate versus transurethral resection', 'ThuVARP or TURP', 'TURP versus ThuVARP', 'Transurethral resection of the prostate (TURP', 'usual TURP procedure (monopolar or bipolar', 'Thulium laser transurethral vaporesection of the prostate (ThuVARP']","['maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS', 'Mean hospital stay', 'hospital stay and complications']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",410.0,0.20003,"INTERPRETATION


TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax.","[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: h.hashim@gmail.com.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Urology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'K Satchi', 'Initials': 'KS', 'LastName': 'Swami', 'Affiliation': 'Urology Department, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30537-7']
1813,32622585,"Corrigendum to ""A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors"" [Clin. Neurophysiol. 131 (2020) 1533-1547].",,2020,,"['pediatric brain tumor survivors"" [Clin', '131']",['exercise training'],['cognition and neural communication'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0160611,,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: arasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.06.002']
1814,32622768,A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease.,"BACKGROUND


Some studies showed encouraging results on the efficacy and safety of penile traction therapy after Peyronie's disease (PD) surgery. The early traction therapy (ETT) could be an effective and safe approach to minimize penile shortening in patients undergoing PD surgery.
AIM


To evaluate the feasibility, efficacy, and safety of a novel penile splint as ETT in patients with PD undergoing grafting techniques.
METHODS


Patients with PD underwent plaque incision and grafting technique; at the end of the procedure, a novel penile splint (ETT) was applied to all patient. The device consisted of 2 10CH intubating stylets, self-adapted to each patient, that kept the penis stretched with the aid of non-absorbable sutures. The total expense for the materials needed to build each penile splint was less than 15 euros. This active traction was maintained for 1-3 weeks; then, we removed the stitches leaving the device on-site for a passive traction. Within 3-4 weeks from surgery, the penile splint was replaced by a standard penile traction device.
OUTCOMES


The main outcomes evaluated at 6 months included stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse.
RESULTS


A total of 46 patients were enrolled. The median preoperative IIEF-EF, penile curvature, and SPL were 27 points, 70°, and 13 cm, respectively. The median follow-up was 15 months. The median postoperative IIEF-EF was 25 points (P < .001). The median residual penile curvature was 10° (P < .001). The median postoperative SPL was 13 cm (P = .269). 8 patients (17.4%) lost 1 cm of SPL; no shortening greater than 1 cm was recorded. The median time to first satisfactory sexual intercourse and patient satisfaction score was 6 weeks and 9 points, respectively.
CLINICAL IMPLICATIONS


Our results could pave the way for a new line of research, which in turn could lead to an improvement in the postoperative management of the patient undergoing surgery for PD.
STRENGTH & LIMITATIONS


This is the first study evaluating the ETT after PD surgery. The main limitation of this study is the lack of a randomized control group. Other weaknesses are the small sample size and the short follow-up time.
CONCLUSION


Our novel penile splint is inexpensive, easy to assemble, and adaptable to the patient. ETT using this novel device, followed by standard traction therapy, seems to be feasible, effective, and safe. Fernández-Pascual E, Manfredi C, Cocci A, et al. A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease. J Sex Med 2020;XX:XXX-XXX.",2020,The median postoperative IIEF-EF was 25 points (P < .001).,"[""after Peyronie's disease (PD) surgery"", 'Patients with PD underwent', 'patients undergoing PD surgery', 'patient undergoing surgery for PD', '46 patients were enrolled', 'patients with PD undergoing grafting techniques']","['novel penile splint as ETT', 'early traction therapy (ETT', 'plaque incision and grafting technique', 'penile traction therapy', 'novel penile splint (ETT', 'Novel Penile Splint as Early Traction Therapy']","['median preoperative IIEF-EF, penile curvature, and SPL', 'median postoperative SPL', 'efficacy and safety', 'median time to first satisfactory sexual intercourse and patient satisfaction score', 'feasibility, efficacy, and safety', 'median postoperative IIEF-EF', 'stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse', 'median residual penile curvature']","[{'cui': 'C0030848', 'cui_str': 'Induratio penis plastica'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",46.0,0.0400712,The median postoperative IIEF-EF was 25 points (P < .001).,"[{'ForeName': 'Esaú', 'Initials': 'E', 'LastName': 'Fernández-Pascual', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain; LYX Institute of Urology, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Manfredi', 'Affiliation': 'Urology Unit, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples ""Federico II"", Naples, Italy. Electronic address: manfredi.celeste@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cocci', 'Affiliation': 'Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Quintana Franco', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'María Alejandra', 'Initials': 'MA', 'LastName': 'Egui Rojo', 'Affiliation': 'Department of Urology, Hospital Universitario HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carballido Rodríguez', 'Affiliation': 'Department of Urology, Hospital Universitario Puerta De Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Martínez-Salamanca', 'Affiliation': 'LYX Institute of Urology, Universidad Francisco de Vitoria, Madrid, Spain; Department of Urology, Hospital Universitario Puerta De Hierro-Majadahonda, Madrid, Spain.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.05.009']
1815,32622774,"Deprescribing in nursing homes: Protocol for nested, randomised controlled hybrid trials of deprescribing interventions.","INTRODUCTION


Polypharmacy and the use of potentially inappropriate medication (PIMs) are frequent among nursing home (NH) residents, and are associated with adverse health outcomes like falls, hospitalisation and death. Deprescribing has been proposed as a way to curtail both problems; however, the best way to implement deprescribing and its real impact are still unclear. This article describes nested trials of two consecutive deprescribing interventions, the first at the NH level, and the second at the resident level.
METHODS AND ANALYSIS


The first intervention (QC-DeMo) will be a deprescribing module to be carried out in existing interprofessional quality circles in NHs, with the goal to develop a NH-wide deprescribing consensus. Its effects will be evaluated on the use of PIMs and on patient safety outcomes such as death, hospitalisation and falls. All NHs in the cantons of Vaud and Fribourg with an integrated pharmacy service will be eligible. The second intervention (IDeI), at the resident level, will be a deprescribing-focused medication review, resulting in the implementation of a deprescribing plan. Its effects will be evaluated on the use of PIMs and chronic medications, and on quality of life. This second trial will take place in the NHs allocated to the intervention group of the first trial. All residents of these NHs over 65 years old, living in the NH for at least 4 months, and taking 5 or more medications will be eligible to participate. Both trials will be hybrid effectiveness and implementation trials, aiming to understand the implementation process for the interventions, and to identify barriers and facilitators.
ETHICS, REGISTRATION AND FUNDING


Both trials were approved by the relevant ethics committee, registered on ClinicalTrials.gov (QC-DeMo: NCT03688542; IDeI: NCT03655405), and funded by the Swiss National Fund for Scientific Research.",2020,"Its effects will be evaluated on the use of PIMs and on patient safety outcomes such as death, hospitalisation and falls.","['Deprescribing in nursing homes', 'All residents of these NHs over 65 years old, living in the NH for at least 4 months, and taking 5 or more medications will be eligible to participate']",[],"['death, hospitalisation and falls', 'quality of life']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0760493,"Its effects will be evaluated on the use of PIMs and on patient safety outcomes such as death, hospitalisation and falls.","[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Cateau', 'Affiliation': 'Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland; School of Pharmaceutical Sciences, University of Geneva, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Switzerland. Electronic address: damien.cateau@unisante.ch.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Ballabeni', 'Affiliation': 'Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mena', 'Affiliation': 'Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland; School of Pharmaceutical Sciences, University of Geneva, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bugnon', 'Affiliation': 'Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland; School of Pharmaceutical Sciences, University of Geneva, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Niquille', 'Affiliation': 'Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Switzerland.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.05.026']
1816,32622784,A Thorough QT Study of the Combination Glecaprevir + Pibrentasvir on Cardiac Repolarization in Healthy Subjects.,"PURPOSE


Fixed-dose combination glecaprevir (GLE) 300 mg + pibrentasvir (PIB) 120 mg is an orally administered once daily antiviral regimen approved for the treatment of hepatitis C virus (HCV) infection. The objective of this study was to evaluate the potential for cardiac repolarization following GLE + PIB administration in healthy adults.
METHODS


This placebo- and active-controlled, randomized, single-dose, 4-period, 4-sequence crossover study enrolled 48 healthy subjects. The doses of GLE 400 mg + PIB 120 mg were selected to provide exposures comparable to those with the doses that are therapeutic in the HCV-infected population, GLE 300 mg + PIB 120 mg. The doses of GLE 600 mg + PIB 240 mg were selected to provide supratherapeutic exposures without exceeding the exposures of the GLE + PIB maximal tolerated doses. Moxifloxacin 400 mg (active control/open label) was used for confirming the sensitivity of the ECG assay in detecting QTc prolongation. Time-matched plasma concentrations and triplicate ECGs were obtained on treatment days -1 and 1. The primary end point was time-matched, placebo-corrected, baseline-adjusted Fridericia-corrected QT interval (ΔΔQTcF). Pharmacokinetic-pharmacodynamic analyses characterized the relationship between GLE and PIB plasma concentrations and ΔΔQTcF using a linear regression model and linear mixed-effects model. Findings from categorical analyses of ECG-interval data were also summarized. Tolerability was evaluated through adverse-events monitoring, physical examination including vital sign measurements, ECGs, and laboratory tests.
FINDINGS


A total of 48 subjects (22 women [46%], 26 men [54%]), were enrolled in the study, and 47 subjects completed all 4 periods. None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec. Peak ΔΔQTcF values observed at 5 h postdose (T max ) were 2.9 msec (upper 95% confidence limit, 4.9 msec) with the therapeutic dose and 3.1 msec (upper 95% confidence limit, 5.1 msec) with the supratherapeutic dose, with both upper 95% confidence limits well below the 10-msec threshold. Assay sensitivity was confirmed by peak ΔΔQTcF in the positive control (12.8 ms at 2 h postdose). No statistically significant GLE or PIB concentration-dependent effects on ΔΔQTcF were observed. Headache and skin irritation from ECG electrodes were the most commonly reported AEs. No clinically significant vital sign measurements, ECG findings, or laboratory measurements were observed. There were no patterns of T- and U-wave morphologic abnormalities.
IMPLICATIONS


The fixed-dose combination regimen of GLE/PIB does not prolong the QTc interval. ClinicalTrials.gov identifier.",2020,None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec.,"['48 subjects (22 women [46%], 26 men [54%]), were enrolled in the study, and 47 subjects completed all 4 periods', 'healthy adults', '48 healthy subjects', 'Healthy Subjects']","['GLE', 'Combination Glecaprevir\xa0+ Pibrentasvir', 'GLE/PIB', '300\xa0mg\xa0+\xa0pibrentasvir (PIB', 'Fixed-dose combination glecaprevir (GLE', 'Moxifloxacin 400\xa0mg (active control/open label', 'GLE\xa0+\xa0PIB administration', 'placebo']","['Cardiac Repolarization', 'QTc interval', 'Assay sensitivity', 'Time-matched plasma concentrations and triplicate ECGs', 'vital sign measurements, ECG findings, or laboratory measurements', 'Peak ΔΔQTcF values', 'time-matched, placebo-corrected, baseline-adjusted Fridericia-corrected QT interval (ΔΔQTcF', 'GLE or PIB concentration', 'adverse-events monitoring, physical examination including vital sign measurements, ECGs, and laboratory tests', 'Headache and skin irritation', 'Tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0438154', 'cui_str': 'ECG finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}]",48.0,0.174435,None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec.,"[{'ForeName': 'Rajneet K', 'Initials': 'RK', 'LastName': 'Oberoi', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA.'}, {'ForeName': 'Weihan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Data and Statistical Sciences, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rosebraugh', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mensa', 'Affiliation': 'Infectious Diseases, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Data and Statistical Sciences, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA. Electronic address: wei.liu@abbvie.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.009']
1817,32622795,A Frailty Screening Tool for Patients undergoing Orthotopic Heart Transplant.,"BACKGROUND


Although frailty has been previously shown to negatively influence post-operative outcomes, frailty measurements remain undefined and underutilized for patients undergoing orthotopic heart transplantation (OHT). This study aims to derive and validate an OHT frailty screening tool.
METHODS


The UNOS database was queried for adults undergoing OHT between 2000 and 2018. The total population was randomly divided into derivation (80%) and validation (20%) cohorts. The primary outcome was mortality. Secondary outcomes included rates of major morbidities and hospital length of stay (LOS). Variables that were constructs within pre-existing frailty tools and that were predictive of a composite frailty outcome within the derivation cohort were incorporated into a multivariable regression model (exploratory, p<0.2). Independent predictors of frailty were included in the OHT frailty screening tool.
RESULTS


36,790 OHT recipients met criteria for inclusion. Twelve variables were identified as independent predictors of frailty and included as OHT frailty screening tool constructs. Recipients in the validation cohort were stratified as non-frail (72.9%, n=5,363), pre-frail (24.4%, n=1,795), and frail (2.7%, n=200). Frail patients had significantly higher rates of post-transplant stroke, renal failure, and mortality at all time intervals as well as longer LOS (all p<0.001). The risk model's predictive rates of mortality strongly correlated with the observed rates of mortality (r 2 =0.97, p<0.001). The c-index of the OHT frailty score was 0.74.
CONCLUSIONS


The OHT frailty screening tool is highly predictive of adverse post-transplant outcomes. This screening tool may provide a framework to improve enhance existing risk stratification tools and improve overall resource utilization.",2020,"Frail patients had significantly higher rates of post-transplant stroke, renal failure, and mortality at all time intervals as well as longer LOS (all p<0.001).","['Frail patients', 'Recipients in the validation cohort were stratified as non-frail (72.9%, n=5,363), pre-frail (24.4%, n=1,795), and frail (2.7%, n=200', 'patients undergoing orthotopic heart transplantation (OHT', 'Patients undergoing Orthotopic Heart Transplant', '36,790 OHT recipients met criteria for inclusion']",[],"['c-index of the OHT frailty score', 'mortality', 'rates of post-transplant stroke, renal failure, and mortality', 'rates of major morbidities and hospital length of stay (LOS']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",36790.0,0.175462,"Frail patients had significantly higher rates of post-transplant stroke, renal failure, and mortality at all time intervals as well as longer LOS (all p<0.001).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seese', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Hirji', 'Affiliation': ""Division of Cardiac Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Sultan', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gleason', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.05.072']
1818,32622847,Systemic beta blockers do not affect glaucoma eye drop effectiveness.,"In this secondary analysis of clinical trial data evaluating IOP elevation following pre-randomization washout of glaucoma eye drops, use of systemic beta-blockers was not associated with a statistically or clinically significant difference in IOP change.",2020,"In this secondary analysis of clinical trial data evaluating IOP elevation following pre-randomization washout of glaucoma eye drops, use of systemic beta-blockers was not associated with a statistically or clinically significant difference in IOP change.",[],[],"['IOP elevation', 'IOP change']",[],[],"[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.40899,"In this secondary analysis of clinical trial data evaluating IOP elevation following pre-randomization washout of glaucoma eye drops, use of systemic beta-blockers was not associated with a statistically or clinically significant difference in IOP change.","[{'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Johnson', 'Affiliation': 'Glaucoma Center of Excellence, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA. Electronic address: johnson@jhmi.edu.'}, {'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Jampel', 'Affiliation': 'Glaucoma Center of Excellence, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.062']
1819,32622871,Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: Combined and sequential approaches.,"Efficient therapies are available for the treatment of osteoporosis. Bisphosphonates and denosumab are the most commonly used antiresorptive therapies. Despite differences in the increase in bone mineral density seen with these drugs, the reductions in fracture risk are similar; 50-70%, 20%, and 40% for vertebral, non-vertebral and hip fractures, respectively. The bone-forming treatments; teriparatide and abaloparatide increase bone mineral density more than the antiresorptives and the reductions in fracture risk are 85% and 40-50% for vertebral and non-vertebral fractures, respectively, compared to placebo. The VERO study demonstrated a >50% reduction in vertebral and clinical fractures in women treated with teriparatide compared to risedronate. The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years. The evidence for combination therapy targeting both resorption and formation is limited as only short-term studies with BMD as the endpoint have been performed. All bone-forming and dual-action treatments increase BMD and reduce the fracture risk, however, the effect wears off with time and treatment is therefore only temporary and should be followed by antiresorptive treatment with a bisphosphonate or denosumab. The sequence of treatment matters as the BMD response to teriparatide is reduced in patients previously treated with bisphosphonates; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with risedronate seems to be preserved after bisphosphonate therapy. The DATA study suggested that transitioning from denosumab to teriparatide is problematic due to the increase in bone resorption occurring after stopping denosumab. Studies have shown further improvements in BMD when transitioning from oral bisphosphonates to zoledronic acid or denosumab. Management of osteoporosis will in many patients include a long-term treatment plan. This will often include sequential therapy which in severe cases preferably should start with bone-forming followed by antiresorptive treatment. The severity of osteoporosis, reaching a treatment goal, and responding to treatment failure are important factors determining the treatment sequence in the individual patient.",2020,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","['patients previously treated with', 'postmenopausal osteoporosis with bone-forming and antiresorptive treatments']","['teriparatide', 'zoledronic acid or denosumab', 'Bisphosphonates and denosumab', 'bisphosphonates', 'alendronate', 'bisphosphonate or denosumab', 'risedronate', 'placebo']","['bone mineral density', 'vertebral and clinical fractures', 'risk of vertebral, non-vertebral and hip fractures', 'BMD', 'risk of vertebral and clinical fractures', 'fracture risk', 'BMD response', 'bone resorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C1286272', 'cui_str': 'Form of bone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",,0.0195905,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Endocrinology and Internal Medicine, Palle Juul Jensen Boulevard 115, DK8200 Aarhus N, Denmark. Electronic address: bente.langdahl@aarhus.rm.dk.'}]",Bone,['10.1016/j.bone.2020.115516']
1820,32622904,"Effects of acute inspiratory loading during treadmill running on cerebral, locomotor and respiratory muscle oxygenation in women soccer players.","Respiratory limitation can be a primary mechanism for exercise cessation in female athletes. This study aimed to assess the effects of IL on intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation in women soccer players during high-intensity dynamic exercise. Ten female soccer players were randomized to perform in order two constant-load tests on a treadmill until the exhaustion time (Tlim) (100% of maximal oxygen uptake- V̇O 2 ). They breathed freely or against a fixed inspiratory loading (IL) of 41 cm H 2 O (∼30% of maximal inspiratory pressure). Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb]), total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI) were obtained by NIRs. Also, blood lactate [La-] was obtained. IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05). IL also resulted in decrease of Δ[OxyHb] of Cox and IM during exercise compared with rest condition. In addition, decrease of Δ[OxyHb] was observed on IM during exercise when contrasted with Sham (P < 0.05). Furthermore, significant higher Δ[DeoxyHb] of IM and significant lower Δ[DeoxyHb] of Cox were observed when IL was applied during exercise in contrast with Sham (P < 0.05). These results were accompanied with significant reduction of Δ[tHb] and ΔTSI of IM and VL when IL was applied (P < 0.05). High-intensity exercise with IL decreased respiratory and peripheral muscle oxygenation with negative impact on exercise performance. However, the increase in ventilatory work did not impact cerebral oxygenation in soccer players.",2020,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","['women soccer players', 'Ten female soccer players', 'female athletes', 'women soccer players during high-intensity dynamic exercise', 'soccer players']","['acute inspiratory loading during treadmill running', 'Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb', 'High-intensity exercise with IL']","['Δ[OxyHb', 'intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation', 'total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI', 'Δ[DeoxyHb', 'Δ[tHb] and ΔTSI of IM and VL', 'increased [La-], V̇O 2 , respiratory cycles and dyspnea', 'blood lactate [La', 'cerebral, locomotor and respiratory muscle oxygenation', 'exercise performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0592251,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","[{'ForeName': 'Flavia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Trimer', 'Affiliation': 'Physical Therapy Department, University of Santa Cruz do Sul - UNISC, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bonjorno-Junior', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Claudio Ricardo', 'Initials': 'CR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103488']
1821,32622918,Abdominal ice following laparoscopic hysterectomy: a randomized controlled trial.,"STUDY OBJECTIVE


To assess impact of abdominal ice packs on opioid use and pain control following laparoscopic hysterectomy DESIGN: Randomized controlled trial SETTING: Academic tertiary care medical center PATIENTS OR PARTICIPANTS: One-hundred-forty-two adult women undergoing laparoscopic (either conventional or robotic) hysterectomy were randomized to control (n=69) or intervention (n=73). Exclusion criteria included preoperative opioid use, planned ICU admission or same-day discharge, an incision ≥4 cm, and regional anesthesia use.
INTERVENTIONS


Subjects in the intervention group had a large ice pack placed directly on the lower abdomen prior to leaving the operating room. The ice pack was maintained continuously for twelve hours post-op, as desired thereafter until discharge, and continued use encouraged after discharge for up to 48 hours.
MEASUREMENTS AND MAIN RESULTS


Total opioids administered postoperatively while inpatient and after dismissal were assessed in morphine milligram equivalents (MME). Postoperative pain, as well as analgesia acceptability and side effects, were assessed using validated measures: the Brief Pain Inventory (BPI) and Overall Benefit of Analgesia Score (OBAS). Median MME was lower in the intervention group compared to controls from inpatient stay on the floor to completion of opioid use as outpatient (22.5 vs 26.2), but was not statistically significant (p=.79). There was no significant difference between groups in BPI assessment of postoperative pain severity (p=.80) or pain interference (p=.36) or OBAS total score (p=.88). The majority in the intervention group were very satisfied with ice pack use (n=51, 79.7%) and very likely to recommend to friends or family (n=54, 83.1%). There were no adverse events related to ice pack use.
CONCLUSIONS


There was no significant difference in postoperative opioid use or pain assessment with ice pack use following laparoscopic hysterectomy. However, the majority of subjects expressed high satisfaction specific to ice pack use and would recommend use to others, suggesting potential desirability as adjunct therapy in postoperative pain control.",2020,There was no significant difference between groups in BPI assessment of postoperative pain severity (p=.80) or pain interference (p=.36) or OBAS total score (p=.88).,"['One-hundred-forty-two adult women undergoing', 'Exclusion criteria included preoperative opioid use, planned ICU admission or same-day discharge, an incision ≥4 cm, and regional anesthesia use']","['laparoscopic hysterectomy', 'large ice pack placed directly on the lower abdomen prior to leaving the operating room', 'laparoscopic (either conventional or robotic) hysterectomy', 'abdominal ice packs']","['Brief Pain Inventory (BPI) and Overall Benefit of Analgesia Score (OBAS', 'OBAS total score', 'analgesia acceptability and side effects', 'postoperative opioid use or pain assessment', 'BPI assessment of postoperative pain severity', 'pain interference', 'Median MME', 'morphine milligram equivalents (MME', 'Postoperative pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",142.0,0.0867692,There was no significant difference between groups in BPI assessment of postoperative pain severity (p=.80) or pain interference (p=.36) or OBAS total score (p=.88).,"[{'ForeName': 'Adela G', 'Initials': 'AG', 'LastName': 'Cope', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Marnie M', 'Initials': 'MM', 'LastName': 'Wetzstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Kristin C', 'Initials': 'KC', 'LastName': 'Mara', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Laughlin-Tommaso', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Nafisseh S', 'Initials': 'NS', 'LastName': 'Warner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, United States of America; Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, United States of America.'}, {'ForeName': 'Tatnai L', 'Initials': 'TL', 'LastName': 'Burnett', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, United States of America. Electronic address: burnett.tatnai@mayo.edu.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.06.027']
1822,32623005,Effect of Behavioral Economic Incentives for Colorectal Cancer Screening in a Randomized Trial.,"BACKGROUND & AIMS


Financial incentives might increase participation in prevention such as screening colonoscopy. We studied whether incentives informed by behavioral economics increase participation in risk assessment for colorectal cancer (CRC) and completion of colonoscopy for eligible adults.
METHODS


Employees of a large academic health system (50-64 y old; n=1977) were randomly assigned to groups that underwent risk assessment for CRC screening and direct access colonoscopy scheduling (control), or risk assessment, direct access colonoscopy scheduling, a $10 loss-framed incentive to complete risk assessment, and a $25 unconditional incentive for colonoscopy completion (incentive). The primary outcome was the percentage of participants who completed screening colonoscopy within 3 months of initial outreach. Secondary outcomes included the percentage of participants who scheduled colonoscopy and the percentage who completed the risk assessment.
RESULTS


At 3 months, risk assessment was completed by 19.5% of participants in the control group (95% CI: 17.0-21.9%) and 31.9% of participants in the incentive group (95% CI: 29.0-34.8%) (P<.001). At 3 months, 0.7% of controls had completed a colonoscopy (95% CI: .2%-1.2%) compared with 1.2% of subjects in the incentive group (95% CI: .5%-1.9%) (P=.25).
CONCLUSIONS


In a randomized trial of participants who underwent risk assessment for CRC with vs without financial incentive, the financial incentive increased CRC risk assessment completion but did not result in a greater completion of screening colonoscopy. Clinicaltrials.gov no: NCT03068052.",2020,"At 3 months, risk assessment was completed by 19.5% of participants in the control group (95% CI: 17.0-21.9%) and 31.9% of participants in the incentive group (95% CI: 29.0-34.8%) (P<.001).","['Employees of a large academic health system (50-64 y old; n=1977', 'colorectal cancer (CRC) and completion of colonoscopy for eligible adults', 'participants who underwent risk assessment for CRC with vs without financial incentive']","['Behavioral Economic Incentives', 'risk assessment for CRC screening and direct access colonoscopy scheduling (control), or risk assessment, direct access colonoscopy scheduling, a $10 loss-framed incentive to complete risk assessment, and a $25 unconditional incentive for colonoscopy completion (incentive']","['percentage of participants who scheduled colonoscopy and the percentage who completed the risk assessment', 'percentage of participants who completed screening colonoscopy within 3 months of initial outreach', 'CRC risk assessment completion', 'risk assessment']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.185879,"At 3 months, risk assessment was completed by 19.5% of participants in the control group (95% CI: 17.0-21.9%) and 31.9% of participants in the incentive group (95% CI: 29.0-34.8%) (P<.001).","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania; Center for Health Care Innovation, University of Pennsylvania; Center for Health Incentives and Behavioral Economics, University of Pennsylvania. Electronic address: shivan.mehta@pennmedicine.upenn.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania; Center for Health Care Innovation, University of Pennsylvania; Center for Health Incentives and Behavioral Economics, University of Pennsylvania.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Niewood', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania; Center for Health Care Innovation, University of Pennsylvania; Center for Health Incentives and Behavioral Economics, University of Pennsylvania; Center for Health Equity Research and Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania; Center for Health Care Innovation, University of Pennsylvania; Center for Health Incentives and Behavioral Economics, University of Pennsylvania; Center for Health Equity Research and Promotion, Philadelphia VA Medical Center.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.047']
1823,32623059,APPLYING AN IMMERSIVE TUTORIAL IN VIRTUAL REALITY TO LEARNING A NEW TECHNIQUE.,"OBJECTIVE


The medical world is continuously evolving, with techniques being created or improved almost daily. Immersive virtual reality (VR) is a technology that could be harnessed to develop tools that meet the educational challenges of this changing environment. We previously described the immersive tutorial, a 3D video (filmed from the first-person point of view), displayed on a VR application. This tool offers access to supplementary educational data in addition to the video. Here we attempt to assess improvement in learning a technique using this new educational format.
MATERIAL AND METHODS


We selected a single neurosurgical technique for the study: external ventricular drainage. We wrote a technical note describing this procedure and produced the corresponding immersive tutorial. We conducted a prospective randomized comparative study with students. All participants read the technical note, and one group used the immersive tutorial as a teaching supplement. The students completed a multiple-choice questionnaire immediately after the training and again at six months.
RESULTS


One hundred seventy-six fourth-year medical students participated in the study; 173 were included in assessing the immediate learning outcomes and 72 were included at the six-month follow-up. The VR group demonstrated significantly better short-term results than the control group (p = 0.01). The same trend was seen at six months.
CONCLUSION


To our knowledge, this study presents one of the largest cohorts for VR. The use of the immersive tutorial could enable a large number of healthcare professionals to be trained without the need for expensive equipment.",2020,The VR group demonstrated significantly better short-term results than the control group (p = 0.01).,"['students', 'One hundred seventy-six fourth-year medical students participated in the study; 173 were included in assessing the immediate learning outcomes and 72 were included at the six-month follow-up']",['Immersive virtual reality (VR'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",[],,0.021312,The VR group demonstrated significantly better short-term results than the control group (p = 0.01).,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Ros', 'Affiliation': 'Education Sciences School - LIRDEF, Montpellier University 3, 2 Place Marcel Godechot, 34000 Montpellier, France. Electronic address: maximeros@gmail.com.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Debien', 'Affiliation': ""Medical Simulation Training Center, 641 Avenue du Doyen Gaston Giraud, 34090 Montpellier, France; Montpellier Medical School, 2 Rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cyteval', 'Affiliation': ""Radiology Department, Lapeyronie Hospital, 371 Avenue du Doyen Gaston Giraud, 34090 Montpellier, France; Montpellier Medical School, 2 Rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': ""IT Medical Department, Lapeyronie Hospital, 371 Avenue du Doyen Gaston Giraud, 34090 Montpellier, France; Montpellier Medical School, 2 Rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Gatto', 'Affiliation': 'Education Sciences School - LIRDEF, Montpellier University 3, 2 Place Marcel Godechot, 34000 Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lonjon', 'Affiliation': ""Neurosurgery Department, Gui de Chauliac Hospital, 80 Avenue Augustin Fliche, 34295 Montpellier, France; Montpellier Medical School, 2 Rue de l'École de Médecine, 34090 Montpellier, France.""}]",Neuro-Chirurgie,['10.1016/j.neuchi.2020.05.006']
1824,32623088,Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial.,"BACKGROUND


After pylorus-preserving pancreaticoduodenectomy (PPPD), incision and suture of the abdominal muscles cause inflammatory changes and elicit somatic pain that deteriorates the quality of life. There have been no previous reports on needle electrical twitch obtaining intramuscular stimulation (NETOIMS) in abdominal open surgery; thus, this study aimed to apply NETOIMS for postoperative somatic pain in patients undergoing PPPD as a new treatment modality for pain control.
METHODS


Between June 2018 and January 2019, 44 patients who underwent PPPD were randomly assigned to the control group and NETOIMS group. The NETOIMS group received NETOIMS in the transverse abdominis muscle under ultrasound guidance right after surgery under general anesthesia. The pain score (visual analog scale, VAS), peak cough flow (PCF), and gait speed were repetitively measured from a day before surgery to 2 weeks after discharge as scheduled. Data were analyzed by the linear mixed model and repeated measures analysis of variance.
RESULTS


Of the 44 patients recruited, data of 38 patients were finally analyzed. The pain scores were significantly lower in the NETOIMS group after PPPD (P = 0.01). Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group.
CONCLUSIONS


The NETOIMS helps in rapid reduction of postoperative somatic pain developed after PPPD and in improvement of PCF and gait speed.",2020,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group.
","['44 patients recruited, data of 38 patients were finally analyzed', 'Patients Undergoing Open Pancreaticoduodenectomy', 'after surgery under general anesthesia', 'Between June 2018 and January 2019, 44 patients who underwent PPPD', 'patients undergoing PPPD as a new treatment modality for pain control']","['transverse abdominis muscle under ultrasound guidance right', 'Intramuscular Electrical Stimulation']","['pain scores', 'gait speed', 'PCF and gait speed', 'Postsurgical Nociceptive Pain', 'improvement of PCF', 'pain score (visual analog scale, VAS), peak cough flow (PCF), and gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C3178766', 'cui_str': 'Nociceptive Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",38.0,0.0740017,"Although the PCF at each measuring time point did not show inter-group difference (P = 0.20), improvement of PCF from the second day of surgery to discharge was greater (P = 0.02) and gait speed improved significantly faster (P < 0.01) in the NETOIMS group than in the control group.
","[{'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital, Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung Sun', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital, Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital, Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sanghoon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sangwon', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Jun', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Pancreatobiliary Cancer Clinic, Department of Surgery, Gangnam Severance Hospital, Yonsei University, Seoul, Korea. Electronic address: JSPARK330@yuhs.ac.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.06.008']
1825,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
1826,32602755,"Successful treatment of the face post acne erythema using a topically applied selective alpha 1-Adrenergic receptor agonist, oxymetazoline 1.5%, a controlled left to right face comparative trial.","BACKGROUND


Post-inflammatory erythema (PIE) is a common sequalae of acne inflammation, persistent post acne erythema (PAE) is cosmetically unacceptable and sometimes its complete clearance could not be achieved. Oxymetazoline (OXZ) is a synthetic, direct-acting, sympathomimetic agonist that is highly selective for the 1α-adrenoceptor. It is a potent vasoconstrictor and well known for its ability to clinically 'get the red out'.
AIM


The aim of this study was to evaluate the efficacy and safety of topical oxymetazoline (OXZ) 1.5% in treatment of post acne erythema (PAE) in a left to right face comparative study.
METHODS


This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control.
RESULTS


According to the investigator's global assessment of photographs and the analysis of erythema with image analysis software, topical OXZ was significantly effective in diminishing PAE when compared to topical placebo lipogel.
CONCLUSION


Topical OXZ is a safe and effective treatment for post-acne erythema.",2020,"This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control.  ","['post acne erythema', '40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with']","['topical oxymetazoline (OXZ', 'OXZ', 'topical OXZ 1.5% in liposomal', 'Oxymetazoline (OXZ']",['efficacy and safety'],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0250483,"This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control.  ","[{'ForeName': 'Naglaa', 'Initials': 'N', 'LastName': 'Agamia', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Essawy', 'Affiliation': 'Oral Pathology Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Kassem', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1789045']
1827,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010']
1828,32599274,Family nurture intervention alters relationships between preterm infant EEG delta brush characteristics and term age EEG power.,"OBJECTIVE


Family Nurture Intervention (FNI) facilitates mother/infant emotional connection, improves neurodevelopmental outcomes and increases electroencephalogram (EEG) power at term age. Here we explored whether delta brushes (DB), early EEG bursts that shape brain development, are altered by FNI and mediate later effects of FNI on EEG.
METHODS


We assessed DB characteristics in EEG data from a randomized controlled trial comparing infants with standard care (SC, n = 31) versus SC + FNI (n = 33) at ~35 and ~40 weeks GA.
RESULTS


Compared to SC infants, FNI infant DB amplitude increased more from ~35 to ~40 weeks, and FNI infants had longer duration DBs. DB parameters (rate, amplitude, brush frequency) at ~35 weeks were correlated with power at ~40 weeks, but only in SC infants. FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
CONCLUSIONS


DBs are related to subsequent brain activity and FNI alters DB parameters. However, FNI's effects on electrocortical activity at term age are not dependent on its earlier effects on DBs.
SIGNIFICANCE


While early DBs can have important effects on later brain activity in preterm infants, facilitating emotional connection with FNI may allow brain maturation to be less dependent on early bursts.",2020,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
","['infants with standard care (SC, n\xa0=\xa031) versus', 'preterm infants']","['Family nurture intervention', 'SC\xa0+\xa0FNI']","['neurodevelopmental outcomes and increases electroencephalogram (EEG', 'FNI infant DB amplitude', 'DB parameters (rate, amplitude, brush frequency', 'longer duration DBs', 'electrocortical activity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0522774,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term.
","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mgw13@columbia.edu.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Grieve', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: pgg3@columbia.edu.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: JB3908@columbia.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: rjl2128@columbia.edu.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: ris2@columbia.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Isler', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: jri2101@columbia.edu.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mmm3@columbia.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.05.020']
1829,32599445,A comparison of the three year course between chronic depression and depression with multiple vs. few prior episodes.,"This study tested the hypothesis that chronic depression (CD) is more similar to depression with multiple prior episodes (ME) than to depression with few prior episodes (FE). Data from participants (n = 1013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an internet intervention for depression (EVIDENT trial) were re-analyzed. The MINI-interview was conducted to diagnose CD (n = 376). If CD was not diagnosed, the self-reported number of depressive episodes was used to categorize participants as having episodic depression with up to five (FE, n = 422) or more than five (ME, n = 215) prior episodes. Over a three-year period, participants were assessed repeatedly regarding the course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2). At baseline, most scores were different between CD and FE but comparable between CD and ME. Time to remission did not differ between CD and ME but was longer in CD compared to FE. Results suggest that ME closely resembles CD and that CD differs from FE.",2020,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,['Data from participants (n\xa0=\xa01013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an'],['internet intervention'],"['Time to remission', 'course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]",1013.0,0.0348744,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,"[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Humer', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Kocsis-Bogar', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Späth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia AG, Hamburg, Germany; Department of Psychology, City, University of London, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Psychology, University of Trier, Trier, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany. Electronic address: philipp.klein@uksh.de.'}]",Psychiatry research,['10.1016/j.psychres.2020.113235']
1830,32603336,Short-term effect of osteopathic manual techniques (OMT) on respiratory function in healthy individuals.,"BACKGROUND


Respiratory system diseases are some of the most common pathologies worldwide. Although osteopathic manual therapy (OMT) is used predominantly to treat other pathologies, certain OMT techniques have been shown to improve patients' respiratory function.
OBJECTIVES


The aim of this study was to assess the influence of osteopathic techniques on breathing.
METHODS


Tests were performed with the use of a spirometer and the results were expressed as Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF). Thirty healthy males and females between the age of 18 and 50 took part in the research. Fifteen individuals were randomly assigned to the experimental group and fifteen persons were assigned to the placebo group. The participants from the experimental group were treated with such osteopathic techniques aimed at the pulmonary system as the thoracic thrust (manipulations of vertebral joints and ribs), the sternal pump technique and stretching of the diaphragm. The placebo group was treated with soft tissue therapy (STT) techniques for the masseter muscle.
RESULTS


The described set of osteopathic techniques exerts an influence on PEF in healthy individuals; however, it does not affect FVC and FEV1.
CONCLUSION


Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.",2020,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","['Fifteen individuals', 'Thirty healthy males and females between the age of 18 and 50 took part in the research', 'healthy individuals']","['osteopathic manual therapy (OMT', 'soft tissue therapy (STT) techniques', 'sternal pump technique and stretching of the diaphragm', 'osteopathic manual techniques (OMT', 'placebo']","['Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF', 'lung health', 'respiratory function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C3658309', 'cui_str': 'Soft Tissue Therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",30.0,0.044022,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Stępnik', 'Affiliation': 'Still Academy of Osteopathy, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kędra', 'Affiliation': 'Faculty of Physical Education and Health, Józef Pilsudski University of Physical Education in Warsaw, Biała Podlaska, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Czaprowski', 'Affiliation': 'Department of Health Sciences, Physiotherapy Unit, University of Medical Science, Poznań, Poland.'}]",PloS one,['10.1371/journal.pone.0235308']
1831,32603351,Low-intensity blood flow restriction calf muscle training leads to similar functional and structural adaptations than conventional low-load strength training: A randomized controlled trial.,"The purpose of this study was to investigate whether a six-week, twice weekly resistance training (4 sets at 30% 1-RM until failure) with practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR) concerning muscle mass and strength gains in calf muscles. A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years) randomized matched pair design based on initial 1-RM was used to assess the effects on structural and functional adaptations in healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound [MT], 7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS]). The mean number of repetitions completed per training session across the intervention period was higher in the NoBFR group compared to the BFR group (70 (16) vs. 52 (9), p = 0.002). VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001). No group effects or time×group interactions were found for CV, MT, LS, and 1-RM. However, there were significant time effects for MT (BFR +0.07 cm; NoBFR +0.04; p = 0.008), and 1-RM (BFR +40 kg; NoBFR +34 kg; p<0.001). LS and CV remained unchanged through training. VAS in both groups were similar, and BFR and NoBFR were equally effective for increasing 1-RM and MT in trained males. However, BFR was more time efficient, due to lesser repetition per training session.",2020,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"['A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years']","['practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR', 'healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound', 'conventional low-load strength training', 'Low-intensity blood flow restriction calf muscle training']","['CV, MT, LS, and 1-RM', 'VAS', 'LS and CV', '1-RM', '7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS', 'mean number of repetitions completed per training session']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0201696,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gavanda', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Isenmann', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schlöder', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Freiwald', 'Affiliation': 'Department of Sport Science Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schiffer', 'Affiliation': 'Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Geisler', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behringer', 'Affiliation': 'Institute of Sports Sciences, Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0235377']
1832,32603357,Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization: A randomized controlled crossover simulation study (CONSORT).,"BACKGROUND


Needle guides for ultrasound-guided internal jugular venous catheterization facilitate successful cannulation. The ability of a needle guide to prevent a posterior vein wall injury which may secondarily induce lethal complications, is unknown. Previous studies showed that a shallow angle of approach may reduce the incidence of posterior wall injuries. We developed a novel needle guide with a shallow angle of approach for ultrasound-guided venous catheterization and examined whether this needle guide reduces the incidence of posterior wall injuries compared to a conventional needle guide and free-hand placement in a simulated vein.
METHODS


This study was a randomized crossover-controlled trial. The primary outcome was the rate of posterior vein wall injuries. Participants had a didactic lecture about three ultrasound-guided techniques using the short-axis out-of-plane approach, including free-hand (P-free), a commercial needle guide (P-com), and a novel needle guide (P-sha). The view inside a simulated vein was recorded during venipuncture.
RESULTS


Thirty-five residents participated in this study. Posterior vein wall injuries occurred in 66% using P-free, 60% using P-com, and 0% using P-sha (p< 0.01). There was no significant difference in the incidence of posterior vein wall injuries between P-free and P-com.
CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",2020,"CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",['Thirty-five residents participated in this study'],['Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization'],"['rate of posterior vein wall injuries', 'incidence of posterior vein wall injuries', 'Posterior vein wall injuries', 'rate of posterior vein injuries']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0181951', 'cui_str': 'Needle guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0226509', 'cui_str': 'Structure of wall of vein'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein'}]",35.0,0.0425578,"CONCLUSIONS


Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.","[{'ForeName': 'Kunitaro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Joho', 'Initials': 'J', 'LastName': 'Tokumine', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yorozu', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0235519']
1833,32603380,Treatment outcomes of Pumani bubble-CPAP versus oxygen therapy among preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial.,"BACKGROUND


Respiratory distress syndrome (RDS) is the most common respiratory disease in premature babies and the major cause of morbidity and mortality among preterm babies. Effective treatment of these babies requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in low and middle income countries. A cheaper, simpler and more accessible treatment for preterms with RDS called bubble-continuous positive airway pressure (bCPAP) has been reported to be effective in treating RDS in preterm babies with varying levels of effectiveness ranging from 42% to 85%. We aimed to implement and determine the efficacy of bCPAP and its immediate outcomes as compared to oxygen therapy in preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania.
METHOD


A randomized control trial, conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria. The primary outcome was survival while the secondary outcomes were treatment duration, duration of hospital stay and treatment complications.
RESULTS


A total of 824 babies were admitted in the neonatal care unit during the study period. Of these, 187 babies were preterm and 48 babies were recruited and randomized (25 bCPAP vs 23 oxygen). The overall survival to discharge for all eligible participants (n = 48) was 58.2% compared to those who adhered to treatment protocol (n = 45, 62.2%). Babies in the bCPAP group had higher survival (17/22; 77.3%) as compared to their counterparts in the oxygen therapy group (11/23; 47.8%). Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy. The median duration of treatment for babies in the oxygen therapy group was 2 (Range 0-16) days compared to 2 (Range 0-5) days in the bCPAP group. The median duration of hospital stay for babies receiving bCPAP was 14 (range 7-43) days. Nasal bleeding was commonly observed among babies in the bCPAP group as compared to those in the oxygen therapy group.
CONCLUSION


This study revealed that treatment with bCPAP had a 30% clinical improvement in survival to discharge. Our findings highlight the role of bCPAP in reducing neonatal mortality in resource limited settings but further adequately powered studies in this or similar settings are required.",2020,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","['conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania', '187 babies were preterm and 48 babies', 'Respiratory distress syndrome (RDS', 'preterm babies', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial', '824 babies were admitted in the neonatal care unit during the study period']","['oxygen therapy', 'bCPAP', 'Pumani bubble-CPAP versus oxygen therapy']","['Nasal bleeding', 'median duration of hospital stay', 'risk of death', 'survival to discharge', 'median duration of treatment for babies', 'treatment duration, duration of hospital stay and treatment complications', 'survival', 'neonatal mortality', 'overall survival to discharge', 'higher survival']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",824.0,0.182245,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","[{'ForeName': 'Annette Baine', 'Initials': 'AB', 'LastName': 'Mwatha', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mahande', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Raimos', 'Initials': 'R', 'LastName': 'Olomi', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Philemon', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}]",PloS one,['10.1371/journal.pone.0235031']
1834,32604809,Development and Evaluation of a Gatekeeper Training Program Regarding Anxiety about Radiation Health Effects Following a Nuclear Power Plant Accident: A Single-Arm Intervention Pilot Trial.,"After the Fukushima Daiichi Nuclear Power Plant accident in March 2011, residents perceived a radiation exposure risk. To address the concerns about radiation exposure and the subsequent effects on their health, we developed the gatekeeper training program for radiation health anxiety and mental health issues. The program consisted of a presentation and roleplay, with educational objectives to the increase knowledge and understanding around radiation health anxiety, alcoholism, depression, and suicide. Twenty-six counselors participated in the program as a single-arm intervention. To measure the outcomes, the subjects reported self-confidence when they counselled with residents with radiation health anxiety and other mental health issues. Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p  < 0.001). Regarding radiation health anxiety the questions ""Can you communicate coping skills to a resident with radiation health anxiety?"" ( p  = 0.007) and ""Can you refer a resident with radiation health anxiety to professionals who can cope appropriately?"" ( p  = 0.016) showed significant increases in their confidence levels. This program could be useful for on-going health activities and future nuclear disasters.",2020,"Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p  < 0.001).",['Twenty-six counselors participated in the program as a single-arm intervention'],['Gatekeeper Training Program'],[],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],26.0,0.0210648,"Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p  < 0.001).","[{'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Orui', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Horikoshi', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17124594']
1835,32604939,"Effects of Manual Therapy on Fatigue, Pain, and Psychological Aspects in Women with Fibromyalgia.","Fibromyalgia is a condition characterised by chronic widespread muscle pain and fatigue, sleep disturbances, cognitive disorders, and mood disturbance. The purpose of this study was to determine the effectiveness of a manual therapy technique performed with moderate digital pressure in women with fibromyalgia ( n  = 24). In this randomised, controlled trial, the participants were randomly assigned to the experimental group or placebo group. The experimental group was assisted with manual therapy sessions based on connective tissue massage, whereas the placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo. Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29) were completed before and after the intervention. In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p  < 0.001). Correlations showed a relationship between fatigue and sleep variables ( R  = 0.411;  p  = 0.046) and pain variables with the POMS anger-hostility subscale ( R  = 0.436;  p  = 0.033). Although the size of the sample could be a limitation, the study concluded that the application of manual therapy in fibromyalgia patients performed with moderate pressure for 15 min on the posterior cervical musculature decreased the perception of pain, muscle fatigue, and the state of tension-anxiety.",2020,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p  < 0.001).","['Women with Fibromyalgia', 'fibromyalgia patients', 'women with fibromyalgia ( n  = 24']","['Manual Therapy', 'manual therapy technique', 'placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo', 'placebo']","['VAS scale, referring to the neck pain', 'fatigue and sleep variables', 'pain variables with the POMS anger-hostility subscale', 'perception of pain, muscle fatigue, and the state of tension-anxiety', 'Fatigue, Pain, and Psychological Aspects', 'Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",,0.0398758,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p  < 0.001).","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Nadal-Nicolás', 'Affiliation': 'Faculty of Medicine, Miguel Hernández University of Elche, 03202 Elche, Spain.'}, {'ForeName': 'Jacobo Ángel', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Department of Health and Human Performance, Faculty of Physical Activity and Sport Science, Polytechnic University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez-Olcina', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reche-García', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Hernández-García', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Faculty of Sciences, Department of Analytical Chemistry, Nutrition and Food Sciences, University of Alicante, 03690 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124611']
1836,32611737,Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn's disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course.,"INTRODUCTION


Immunomodulators such as thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA) are well established for maintenance of remission within paediatric Crohn's disease (CD). It remains unclear, however, which maintenance medication should be used first line in specific patient groups.
AIMS


To compare the efficacy of maintenance therapies in newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution; MTX versus AZA/6MP in low-risk and MTX versus ADA in high-risk patients. Primary end point: sustained remission at 12 months (weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
METHODS AND ANALYSIS


REDUCE-RISK in CD is an international multicentre open-label prospective randomised controlled trial funded by EU within the Horizon2020 framework (grant number 668023). Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal CD are stratified into low and high-risk groups based on phenotype and response to induction therapy. Participants are randomised to one of two treatment arms within their risk group: low-risk patients to weekly subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA. Patients are followed up for 12 months at prespecified intervals. Electronic case report forms are completed prospectively. The study aims to recruit 312 participants (176 low risk; 136 high risk).
ETHICS AND DISSEMINATION


ClinicalTrials.gov Identifier: (NCT02852694), authorisation and approval from local ethics committees have been obtained prior to recruitment. Individual informed consent will be obtained prior to participation in the study. Results will be published in a peer-reviewed journal with open access.
TRIAL REGISTRATION NUMBER


NCT02852694; Pre-results.",2020,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
","['high-risk patients', ""paediatric Crohn's disease"", 'patients at low or high risk for aggressive disease course', '312 participants (176 low risk; 136 high risk', 'newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution', 'Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal\u2009CD']","['subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA', 'methotrexate versus azathioprine or adalimumab', 'thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA', 'MTX versus AZA/6MP', 'MTX versus ADA']",['sustained remission'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0341395', 'cui_str': ""Perianal Crohn's disease""}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.125767,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Harris', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Aloi', 'Affiliation': 'Paediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Roma, Lazio, Italy.'}, {'ForeName': 'Lissy', 'Initials': 'L', 'LastName': 'de Ridder', 'Affiliation': 'Paediatrics, Erasmus MC/Sophia Childrens Hospital, Rotterdam, The Netherlands l.deridder@erasmusmc.nl.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Croft', 'Affiliation': 'Department of Paediatric Gastroenterology, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Koletzko', 'Affiliation': ""Pediatric Gastroenterology and Hepatology, Dr. V. Hauner Children's Hospital, Munich, Germany.""}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Edith Wolfson Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Department of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Gigi', 'Initials': 'G', 'LastName': 'Veereman', 'Affiliation': 'Pediatric GI, UZBrussels-VUB, Brussels, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Neyt', 'Affiliation': 'ME-TA Medical Evaluation and Technology Assessment, Merendree, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': 'PIBD-Net, Hôpital universitaire Necker-Enfants malades, Paris, Île-de-France, France.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Ruemmele', 'Affiliation': 'Service de Gastroentérologie Pédiatrique, Hôpital Universitaire Necker-Enfants Malades, Paris, Île-de-France, France.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Russell', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034892']
1837,32611863,"Comparison of antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of primary teeth.","Aim


Sodium hypochlorite, though considered an ideal root canal irrigant, cannot be used at required concentrations in children, due to its undesirable effects. Hence, it is imperative to search for an ideal root canal irrigant to avoid these undesirable effects which we hope to achieve with this study. The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared.
Materials and Methods


Sixty patients between 4 and 8 years of age with a single-rooted deciduous tooth indicated for pulpectomy were included. The infected teeth were randomly allocated to one of the three treatment groups based on the irrigating agents used, namely normal saline, green tea extract, or ozonated water. Specimens for anaerobic culture were collected three times from the teeth: before irrigation, after initial irrigation, and on the 3 rd  day after final irrigation.
Results and Conclusion


Mean colony forming unit (CFU) count after both initial and final irrigation with ozonated water was significantly lower when compared with green tea and normal saline. Further, it was observed that the mean CFU count with green tea was significantly lower than the counts obtained with normal saline on the 3 rd  day after final irrigation. Hence, both ozonated water and green tea could be considered a good alternative to conventional root canal irrigants in the primary teeth. Larger sample sizes with a larger variety of irrigants are recommended.",2020,"The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared.
","['Sixty patients between 4 and 8 years of age with a single-rooted deciduous tooth indicated for pulpectomy were included', 'pulpectomy procedures of primary teeth']","['irrigating agents used, namely normal saline, green tea extract, or ozonated water', 'aqueous ozone, green tea, and normal saline', 'green tea and normal saline']","['Mean colony forming unit (CFU) count', 'mean CFU count with green tea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449881', 'cui_str': 'Agent used'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]",60.0,0.035336,"The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared.
","[{'ForeName': 'Suchi', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Bhabha College of Dental Sciences, Bhopal, India.'}, {'ForeName': 'Parimala', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': ""Department of Pedodontics and Preventive Dentistry, People's College of Dental Sciences and Research Centre, Bhopal, India.""}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'Department of Oral Medicine and Radiology, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Children Dental College, Azamgarh, Uttar Pradesh, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Orthodontics and Maxillofacial Orthopedics, Bhabha College of Dental Sciences, Bhopal, India.'}, {'ForeName': 'Kuldeep Singh', 'Initials': 'KS', 'LastName': 'Rana', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Government College of Dentistry, Indore, Madhya Pradesh, India.'}]",Journal of the Indian Society of Pedodontics and Preventive Dentistry,['10.4103/JISPPD.JISPPD_119_20']
1838,32613565,"Assessing the impact of a combination of sofosbuvir and daclatasvir treatment for hepatitis C virus infection on heart rate, rhythm and heart rate variability using 24-hour ECG monitoring.","BACKGROUND


Direct-acting antiviral agents (DAAs) cure patients with hepatitis C virus (HCV) infection. Concerns have arisen the occurrence of significant bradyarrhythmias during treatment with DAAs. The aim of this study was to assess the impact of a DAA combination for the treatment of HCV infection on heart rate, rhythm, and heart rate variability (HRV) using 24-h ECG monitoring.
RESULTS


A prospective randomized study of 50 treatment-naïve patients with HCV infection treated with a combination of sofosbuvir 400 mg daily and daclatasvir 60 mg daily for 12 weeks. Surface ECG and 24-h ECG monitoring were performed at baseline and after completion of therapy to assess PR interval, corrected QT interval (QTc), minimum heart rate (HR), maximum HR, average HR, HRV time-domain and frequency-domain measures, significant pauses, tachycardias, bradycardias, premature atrial contractions (PACs), and premature ventricular contraction (PVCs). No differences were detected in all examined parameters between baseline and after completion of treatment. PR interval was 154 ± 25.95 vs 151.4 ± 23.82 ms, respectively (p = 0.124). QTc interval was 397.34 ± 29.38 vs 395.04 ± 30.23 ms, respectively (p = 0.403). No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs. No episodes of bradyarrhythmias, syncope, and atrial fibrillation, supraventricular, or ventricular tachycardias were reported or detected.
CONCLUSION


In non-cardiac patients receiving no cardioactive medications, the combination of sofosbuvir and daclatasvir for the treatment of HCV infection has no effect on HR, rhythm, conductivity, or HRV. No symptomatic bradycardias, tachycardias, or syncope were reported or detected using 24-h ECG monitoring.",2020,"No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs.","['50 treatment-naïve patients with HCV infection treated with a', 'cure patients with hepatitis C virus (HCV) infection']","['DAA combination', 'sofosbuvir and daclatasvir treatment', 'Direct-acting antiviral agents (DAAs', 'combination of sofosbuvir 400 mg daily and daclatasvir']","['HR, rhythm, conductivity, or HRV', 'minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs', 'symptomatic bradycardias, tachycardias, or syncope', 'heart rate, rhythm, and heart rate variability (HRV', 'episodes of bradyarrhythmias, syncope, and atrial fibrillation, supraventricular, or ventricular tachycardias', 'Surface ECG and 24-h ECG monitoring', 'PR interval, corrected QT interval (QTc), minimum heart rate (HR), maximum HR, average HR, HRV time-domain and frequency-domain measures, significant pauses, tachycardias, bradycardias, premature atrial contractions (PACs), and premature ventricular contraction (PVCs', 'heart rate, rhythm and heart rate variability']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085610', 'cui_str': 'Sinus bradycardia'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0079035', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.0253685,"No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs.","[{'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'El Missiri', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. amissiri@med.asu.edu.eg.'}, {'ForeName': 'Mona Mostafa', 'Initials': 'MM', 'LastName': 'Rayan', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Mohamed Medhat', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Ahmed Ibrahim', 'Initials': 'AI', 'LastName': 'El Desoky', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00070-4']
1839,32614422,Association of Atrial Fibrillation Episode Duration With Arrhythmia Recurrence Following Ablation: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Contemporary guidelines recommend that atrial fibrillation (AF) be classified based on episode duration, with these categories forming the basis of therapeutic recommendations. While pragmatic, these classifications are not based on pathophysiologic processes and may not reflect clinical outcomes.
Objective


To evaluate the association of baseline AF episode duration with post-AF ablation arrhythmia outcomes.
Design, Setting, and Participants


The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (the Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation. Data analysis was performed in September 2019.
Exposure


Before ablation, patients were classified based on their longest AF episode. Ablation consisted of circumferential pulmonary vein isolation using standard techniques.
Main Outcomes and Measures


Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring.
Results


The study included 346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men). Overall, 263 patients (76.0%) had AF episode duration of less than 24 hours; 25 (7.2%), 24 to 48 hours; 40 (11.7%), 2 to 7 days; and 18 (5.2%), more than 7 days. Documented recurrence of any atrial tachyarrhythmia following ablation was significantly lower in patients with baseline AF episode duration of less than 24 continuous hours compared with those with longer AF episodes (24 hours vs 24-48 hours: hazard ratio [HR], 0.41; 95% CI, 0.21-0.80; P = .009; 24 hours vs 2-7 days: HR, 0.25; 95% CI, 0.14-0.45; P < .001; 24 hours vs >7 days: HR, 0.23; 95% CI, 0.09-0.55; P < .001). Patients with preablation AF episodes limited to less than 24 continuous hours had a significantly lower median (interquartile range) postablation AF burden (0% [0%-0.1%]) compared with those with AF preablation episodes lasting 2-7 days (0.1% [0%-1.0%]; P = .003) and those with AF preablation episodes lasting more than 7 days (1.0% [0%-5.4%]; P = .008). There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours.
Conclusions and Relevance


In this study, patients with AF episodes limited to less than 24 continuous hours had a significantly lower incidence of arrhythmia recurrence following AF ablation. This suggests that current guidelines for classification of AF may not reflect clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01913522.",2020,"There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours.
","['Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled', '346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men']","['Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE', 'circumferential pulmonary vein isolation using standard techniques', 'Ablation']","['recurrence of any atrial tachyarrhythmia following ablation', 'Measures\n\n\nTime to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring', 'AF episode duration', 'median (interquartile range) postablation AF burden', 'arrhythmia recurrence or AF burden', 'Atrial Fibrillation Episode Duration With Arrhythmia Recurrence', 'arrhythmia recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}]",346.0,0.182789,"There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours.
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Nattel', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.8748']
1840,32614482,A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating: a feasibility study.,"AIM


To examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour.
METHODS


Twenty-seven adolescents with type 1 diabetes were recruited and randomized to receive the brief (two 2.5-h sessions) self-compassion intervention, either in the intervention group (n=11) or in a waitlist control group (n=8). The intervention was adapted from the standardized eight-session 'Making Friends with Yourself' programme, and sessions were delivered 1 week apart. Acceptability was assessed through qualitative questionnaires and feasibility was assessed based on session attendance and recruitment metrics. Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
RESULTS


Nineteen participants completed the study, and they reported an increased sense of common humanity (acknowledging that we are not alone), mindfulness, and coping resources. In terms of feasibility, recruitment took longer than expected (8 months) and not all participants were able to attend both sessions (nine could only attend one of the two sessions).
CONCLUSIONS


While self-compassion is a strong conceptual fit for the issues of type 1 diabetes and disordered eating behaviour in adolescence, and the intervention content appears acceptable, feasibility issues were such that brief self-compassion programmes will probably need to be adapted into digital interventions for future research. (Trial registration number: ANZCTR 12619000541101).",2020,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
","['Twenty-seven adolescents with type 1 diabetes', 'adolescents with type 1 diabetes and disordered eating', 'adolescents with type 1 diabetes and disordered eating behaviour', 'Nineteen participants']","['brief self-compassion intervention', 'self-compassion intervention']","['feasibility and acceptability', 'disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control', 'Acceptability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",27.0,0.0257097,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed.
","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Starship Children's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14352']
1841,32623370,"Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial.","BACKGROUND


Progressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.
OBJECTIVE


To assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.
PARTICIPANTS


The RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.
INTERVENTION


Intraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.
PRIMARY OUTCOME


Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.
RESULTS


Of the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
CONCLUSION


DRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.
TRIAL REGISTRATION NUMBER


ISRCTN80286058.",2020,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","['77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up', 'posthaemorrhagic ventricular dilatation', 'preterm infants', '77 preterm infants with IVH and progressive ventricular enlargement over specified measurements']","['Drainage, irrigation and fibrinolytic therapy (DRIFT', 'fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device']","['mean CQ score', 'severe cognitive impairment', 'Survival without severe cognitive disability', 'Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2675972', 'cui_str': 'Ventricular enlargement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451042', 'cui_str': 'British ability scales'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",77.0,0.16837,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Luyt', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK karen.luyt@bristol.ac.uk.'}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Jary', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Lea', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Odd', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Miller', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Kmita', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Ophthalmology, Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""Child Psychology, Community Children's Health Partnership, Bristol, UK.""}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Smith-Collins', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker-Cox', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Aquilina', 'Affiliation': 'Department of Neurosurgery, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pople', 'Affiliation': 'Paediatric Neurosurgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318231']
1842,32623402,"Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Probiotics use has been associated with modulation of inflammation and considered as a possible intervention for CNS diseases such as mild cognitive impairment (MCI) and dementia.
OBJECTIVE


We aimed to test the effect of the probiotic strain, Bifidobacterium breve A1 (MCC1274), to restore cognition in a physically healthy, suspected MCI population.
METHODS


In this randomized, double-blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were divided into two even groups to receive once daily either probiotic (B. breve A1, 2×1010 CFU) or placebo for 16 weeks using a computer-generated algorithm. Cognitive functions were assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests before and after the study as primary and secondary endpoints, respectively.
RESULTS


79 participants completed the study, and no adverse events were observed. RBANS total score was significantly improved in probiotic group compared with placebo (mean between-group difference 11.3 [95% CI 6.7 to 15.8]; p < 0.0001) after 16 weeks of consumption, in particular with significant improvement in domain scores of immediate memory, visuospatial/constructional, and delayed memory (p < 0.0001), in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
CONCLUSION


Study results indicate B. breve A1 is a safe and effective approach for improving memory functions of suspected MCI subjects.",2020,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","['suspected MCI subjects', 'physically healthy, suspected MCI population', '80 healthy older adults suffering from MCI', 'Older Adults with Suspected Mild Cognitive Impairment']","['Placebo', 'Probiotic Bifidobacterium breve', 'probiotic strain, Bifidobacterium breve A1 (MCC1274', 'probiotic (B. breve A1, 2×1010 CFU) or placebo', 'placebo']","['Cognitive functions', 'JMCIS score', 'Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests', 'Cognitive Functions', 'domain scores of immediate memory, visuospatial/constructional, and delayed memory', 'RBANS total score']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.666455,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","[{'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bernier', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ohno', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Odamaki', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Huma R & D Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Kumie', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Nihonbashi Sakura Clinic, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Tokyo, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200488']
1843,32623425,Work-focused therapy for common mental disorders: A naturalistic study comparing an intervention group with a waitlist control group.,"BACKGROUND


Common mental disorders (CMD) are leading causes of sickness absence. Treatments for CMD that both reduce symptoms and support work participation urgently need to be developed.
OBJECTIVE


Determine the potential effects of work-focused therapy combining work interventions with either meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT) for patients with CMD on sick leave.
METHODS


Naturalistic study with a quasi-experimental approach. Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety) were compared between the intervention group (n = 87) who received immediate treatment over an average of 10.40 sessions (SD = 3.09) and the non-randomized waitlist control group (n = 95) that had waited an average of 11.18 weeks (SD = 2.29).
RESULTS


Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%). Effect sizes for self-efficacy scores, depression and anxiety were large in the intervention group (d = 1.28, 1.01, 1.58), and significantly lower in the control group (d = 0.60, 0.14, 0.45). Significantly more patients in the treatment group than control group recovered from depression (54.1% vs. 12.8%) and anxiety (50% vs.10.63%).
CONCLUSIONS


W-MCT/CBT may be an effective intervention for patients on sick leave due to CMD.",2020,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"['patients with CMD on sick leave', 'Naturalistic study with a quasi-experimental approach', 'common mental disorders']","['meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT', 'W-MCT/CBT']","['anxiety', 'depression', 'self-efficacy scores, depression and anxiety', 'Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0689232,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"[{'ForeName': 'Ragne G H', 'Initials': 'RGH', 'LastName': 'Gjengedal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Osnes', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lagerveld', 'Affiliation': 'The Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Blonk', 'Affiliation': 'Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sandin', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Torkil', 'Initials': 'T', 'LastName': 'Berge', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Odin', 'Initials': 'O', 'LastName': 'Hjemdal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}]","Work (Reading, Mass.)",['10.3233/WOR-203208']
1844,32623429,The Effect of Internal Limiting Membrane Cleaning on Epiretinal Membrane Formation after Vitrectomy for Proliferative Diabetic Retinopathy.,"Purpose We hypothesised that cleaning the internal limiting membrane (ILM) with a flexible nitinol loop following diabetic vitrectomy without peeling may reduce the common occurrence of postoperative epiretinal membrane (ERM) formation. Methods Consecutive patients undergoing vitrectomy for proliferative diabetic retinopathy by one surgeon from 2015-2019 were studied and divided into two cohorts: the control group underwent standard surgery; the ILM-Clean group underwent additional cleaning of the macular retina using a flexible nitinol loop post-vitrectomy. Masked comparison of ERM on optical coherence tomography was performed at 3 months and visual acuity (VA) was measured until 12 months postoperatively. Results Baseline demographics, clinical features and protein levels were similar between cohorts. The ILM-Clean group (n=56) had fewer clinically significant ERM compared to the control group (n=50) (4%vs.20%;p=0.01) and a significantly lower proportion of the ILM-Clean group required revision surgery (2%vs.14%;p=0.02). VA in the ILM-Clean group was significantly better than the control group at 3 months (0.35vs.0.50logMAR;p=0.02) but not at 12 months (0.34vs.0.43logMAR;p=0.17). Conclusion ILM cleaning with a flexible nitinol loop following diabetic vitrectomy resulted in significant reduction in ERM formation and reduced necessity for revision surgery. There was significant improvement in VA at 3 months but not over longer follow-up.",2020,VA in the ILM-Clean group was significantly better than the control group at 3 months (0.35vs.0.50logMAR;p=0.02) but not at 12 months (0.34vs.0.43logMAR;p=0.17).,"['Methods Consecutive patients undergoing vitrectomy for proliferative diabetic retinopathy by one surgeon from 2015-2019', 'Proliferative Diabetic Retinopathy']","['Internal Limiting Membrane Cleaning', 'control group underwent standard surgery; the ILM-Clean group underwent additional cleaning of the macular retina using a flexible nitinol loop post-vitrectomy', 'ERM']","['ERM formation', 'visual acuity (VA', 'optical coherence tomography', 'VA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}]","[{'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",,0.0648856,VA in the ILM-Clean group was significantly better than the control group at 3 months (0.35vs.0.50logMAR;p=0.02) but not at 12 months (0.34vs.0.43logMAR;p=0.17).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Romeela', 'Initials': 'R', 'LastName': 'Rana-Rahman', 'Affiliation': ''}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Klaassen', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': ''}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Steel', 'Affiliation': ''}]",Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde,['10.1159/000509878']
1845,32623550,Management of Less Than 10-mm-Sized Pedunculated (Ip) Polyps with Thin Stalk: Hot Snare Polypectomy Versus Cold Snare Polypectomy.,"BACKGROUND


Although the use of cold snare polypectomy (CSP) has spread rapidly, its safety for pedunculated (Ip) polyps remains controversial. In particular, the outcomes of hot snare polypectomy (HSP) and CSP for Ip polyps have not been previously compared.
AIMS


This study evaluated whether the rate of delayed postpolypectomy bleeding (DPPB) after CSP for Ip polyps was higher than that after HSP for Ip polyps and compared other outcomes (the rates of immediate bleeding and pathological margins) between the HSP and CSP procedures.
METHODS


A total of 5905 colorectal polyps in 4920 patients were resected at Omori Red Cross Hospital between October 2012 and June 2019. The polyps were divided into two groups: the HSP group (86 polyps, 64 patients) and the CSP group (102 polyps, 87 patients). The primary outcome measure was the incidence of DPPB. The secondary outcome measures were the incidences of immediate bleeding during the procedure and pathological margins of the resected specimen.
RESULTS


The rate of immediate bleeding during CSP was significantly higher than that for the HSP group [38.2% (39/102) versus 3.5% (3/86); p < 0.001]. However, the rate of DPPB was significantly higher in the HSP group than in the CSP group [4.7% (4/86) versus 0% (0/102); p < 0.001]. The rate of DPPB after CSP was 0%.
CONCLUSIONS


This is the first study to compare the outcomes of HSP and CSP for Ip polyps. CSP is safer than HSP for Ip polyps measuring < 10 mm in diameter.",2020,The rate of immediate bleeding during CSP was significantly higher than that for the HSP group [38.2% (39/102) versus 3.5% (3/86); p < 0.001].,['A total of 5905 colorectal polyps in 4920 patients were resected at Omori Red Cross Hospital between October 2012 and June 2019'],"['hot snare polypectomy (HSP) and CSP', 'HSP', 'CSP', 'cold snare polypectomy (CSP', 'HSP and CSP', '10-mm-Sized Pedunculated (Ip) Polyps with Thin Stalk: Hot Snare Polypectomy Versus Cold Snare Polypectomy']","['rate of delayed postpolypectomy bleeding (DPPB', 'incidences of immediate bleeding during the procedure and pathological margins of the resected specimen', 'incidence of DPPB', 'rate of immediate bleeding during CSP', 'rate of DPPB']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935572', 'cui_str': 'Stalking'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}]",4920.0,0.10765,The rate of immediate bleeding during CSP was significantly higher than that for the HSP group [38.2% (39/102) versus 3.5% (3/86); p < 0.001].,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Arimoto', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan. junarimoto_junjun@yahoo.co.jp.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Chiba', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikari', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Fukui', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tachikawa', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Suto', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Kawano', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Niikura', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Nakaoka', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ida', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterology, Omori Red Cross Hospital, 4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06436-7']
1846,32623608,"The MelFo Study UK: Effects of a Reduced-Frequency, Stage-Adjusted Follow-Up Schedule for Cutaneous Melanoma 1B to 2C Patients After 3-Years.","BACKGROUND


Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study.
METHODS


The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36.
RESULTS


Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (> 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical.
CONCLUSION


The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection.",2020,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","['British cohort for comparison and validation of the Dutch study', '207 patients by AJCC stage', 'Cutaneous Melanoma 1B to 2C Patients After 3-Years']","['Reduced-Frequency, Stage-Adjusted Follow-Up Schedule']","['Patient anxiety levels', 'Recurrence', 'State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS', 'Quality of life (QoL', 'melanoma-specific survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",207.0,0.0716703,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Moncrieff', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK. marc.moncrieff@nnuh.nhs.uk.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Underwood', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Garioch', 'Affiliation': 'Department of Dermatology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heaton', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Nakul', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Bastiaannet', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Josette E H M', 'Initials': 'JEHM', 'LastName': 'Hoekstra-Weebers', 'Affiliation': 'University Medical Center Groningen, Wenckebach Institute, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Harald J', 'Initials': 'HJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-020-08758-2']
1847,32623628,Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial.,"The feasibility of delayed cord clamping (DCC) in preterm infants with placental insufficiency (PI) is questionable. We aimed to study the effect of DCC on stem cell transfusion, hematological parameters, and clinical outcomes in preterm infants born to mothers with PI. Preterm infants, < 34 weeks' gestation, born to mothers with PI were randomized based on the timing of umbilical cord clamping into delayed clamping for 60 s (DCC group) or immediate cord clamping (ICC group) groups at time of birth. CD34 percentage as a marker of stem cell transfusion, early and late-onset anemia, hypothermia, hypotension, polycythemia, hyperbilirubinemia, duration of oxygen therapy, bronchopulmonary dysplasia, intra-ventricular hemorrhage, necrotizing enterocolitis, sepsis, mortality, and length of hospital stay were compared between studied groups. We found that peripheral blood CD34 percentage was significantly higher in DCC compared with that in the ICC group (median (IQR) of 0.5 (0.40-0.7) versus 0.35 (0.20-0.5), p = 0.004). Infants in the DCC group had significantly lower episodes of anemia of prematurity at 2 months, red blood cell transfusion, and shorter duration of oxygen therapy compared with those in the ICC group.Conclusion: In conclusion, DCC compared with ICC increased stem cell transfusion and decreased early- and late-onset anemia in preterm infants with placental insufficiency.Trial registration: NCT03731546 www.clinicaltrials.gov What is Known: • Delayed cord clamping has been recommended by the American Academy of Pediatrics as a standard of care practice during delivery of preterm infants. • The feasibility of DCC in preterm infants with placental insufficiency (PI) is uncertain. What is New: • This randomized controlled trial demonstrated that DCC in the delivery room care of preterm infants born to mothers with placental insufficiency increased stem cell transfusion and decreased early- and late-onset anemia.",2020,"Infants in the DCC group had significantly lower episodes of anemia of prematurity at 2 months, red blood cell transfusion, and shorter duration of oxygen therapy compared with those in the ICC group.","['preterm infants born to mothers with placental insufficiency increased stem cell transfusion and decreased early- and late-onset anemia', 'preterm infants', 'preterm infants with placental insufficiency', 'preterm infants born to mothers with PI', ""Preterm infants, <\u200934\xa0weeks' gestation, born to mothers with PI"", 'preterm infants with placental insufficiency (PI']","['delayed cord clamping (DCC', 'umbilical cord clamping into delayed clamping for 60\xa0s (DCC group) or immediate cord clamping (ICC', 'ICC', 'DCC', 'delayed cord clamping']","['CD34 percentage as a marker of stem cell transfusion, early and late-onset anemia, hypothermia, hypotension, polycythemia, hyperbilirubinemia, duration of oxygen therapy, bronchopulmonary dysplasia, intra-ventricular hemorrhage, necrotizing enterocolitis, sepsis, mortality, and length of hospital stay', 'peripheral blood CD34 percentage', 'episodes of anemia of prematurity', 'red blood cell transfusion, and shorter duration of oxygen therapy', 'stem cell transfusion and decreased early- and late-onset anemia']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032051', 'cui_str': 'Placental insufficiency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1283172', 'cui_str': 'Umbilical cord clamp'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}]","[{'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0032461', 'cui_str': 'Polycythaemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.103192,"Infants in the DCC group had significantly lower episodes of anemia of prematurity at 2 months, red blood cell transfusion, and shorter duration of oxygen therapy compared with those in the ICC group.","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Yunis', 'Affiliation': ""Neonatal Intensive Care Unit, Department of Pediatrics, Mansoura University Children's Hospital, Gomhoria Street, Mansoura, 35516, Egypt.""}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Nour', 'Affiliation': ""Neonatal Intensive Care Unit, Department of Pediatrics, Mansoura University Children's Hospital, Gomhoria Street, Mansoura, 35516, Egypt.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Gibreel', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sarhan', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Basma', 'Initials': 'B', 'LastName': 'Shouman', 'Affiliation': ""Neonatal Intensive Care Unit, Department of Pediatrics, Mansoura University Children's Hospital, Gomhoria Street, Mansoura, 35516, Egypt.""}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Nasef', 'Affiliation': ""Neonatal Intensive Care Unit, Department of Pediatrics, Mansoura University Children's Hospital, Gomhoria Street, Mansoura, 35516, Egypt. nehad_nasef@mans.edu.eg.""}]",European journal of pediatrics,['10.1007/s00431-020-03730-4']
1848,32623637,Effects of glucagon-like peptide-1 receptor agonists on fluid intake in healthy volunteers.,"PURPOSE


Glucagon-like peptide-1 (GLP-1) receptor agonists (RA) reduce appetite and energy intake. Recent findings from animal studies suggest a role of GLP-1 in drinking and water homeostasis. We aimed to elucidate whether GLP-1 RA reduce fluid intake in healthy volunteers.
METHODS


Double-blind, randomized, placebo-controlled, crossover study. 20 healthy volunteers received dulaglutide 1.5 mg and placebo (0,9% sodium chloride) subcutaneously once weekly for 3 weeks. At the end of each treatment period, participants attended an 8-h evaluation visit, during which they were requested to eat two standardized meals and to drink water ad libitum. The primary outcome was the total fluid intake (ml) during the evaluation visit.
RESULTS


Mean [SD] age of participants (60% female) was 27 [9.2] years. All but four participants drank less on dulaglutide versus placebo treatment despite identical food intake. The median [IQR] difference of fluid intake on dulaglutide compared to placebo treatment was -100 ml [-400-0]. Median [IQR] total fluid intake was 1300 ml [888-1600] versus 1600 ml [1000-1720], on dulaglutide and placebo treatment, p = 0.06. Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04. Median serum sodium levels were 140 mmol/L on both visits and no difference in thirst perception was noted.
CONCLUSIONS


GLP-1 RA such as dulaglutide seem to modulate fluid balance in humans. This leads us to speculate that GLP-1 RA may be an interesting therapeutic options for patients with excessive drinking behavior e.g., primary polydipsia.",2020,"Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04.","['20 healthy volunteers', 'healthy volunteers', 'Mean [SD] age of participants (60% female) was 27 [9.2] years', 'patients with excessive drinking behavior e.g., primary polydipsia']","['Glucagon-like peptide-1', 'dulaglutide 1.5\u2009mg and placebo (0,9% sodium chloride', 'GLP-1 RA', 'glucagon-like peptide-1 receptor agonists', 'placebo']","['Median [IQR] 24-h urine output', 'total fluid intake (ml) during the evaluation visit', 'Median [IQR] total fluid intake', 'median [IQR] difference of fluid intake', 'Median serum sodium levels', 'thirst perception']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683357', 'cui_str': 'Excessive drinking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0268813', 'cui_str': 'Dipsogenic diabetes insipidus'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",20.0,0.630076,"Median [IQR] 24-h urine output was reduced in dulaglutide versus placebo-treated participants: 1250 ml [975-2080] versus 1680 ml [1400-2040], p = 0.04.","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Winzeler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland. bettina.winzeler@usb.ch.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'da Conceição', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Refardt', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Clara O', 'Initials': 'CO', 'LastName': 'Sailer', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dutilh', 'Affiliation': 'Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",Endocrine,['10.1007/s12020-020-02394-2']
1849,32623812,Effects of vitamin D supplementation on disabling foot pain in patients with symptomatic knee osteoarthritis.,"OBJECTIVES


This study aims to determine whether vitamin D supplementation or maintaining sufficient vitamin D level reduces foot pain over two years in patients with symptomatic knee OA.
METHODS


A post hoc study was conducted from a randomized double-blind placebo-controlled trial named the VItamin D Effect on Osteoarthritis (VIDEO) study. Symptomatic knee OA patients with serum 25-hydroxyvitamin D levels between 12.5 nmol/L to 60 nmol/L were included and randomly allocated to either monthly vitamin D3 or placebo treatment (1:1) for 2 years. Manchester Foot Pain and Disability Index (MFPDI) was used to evaluate foot pain and Disabling foot pain was defined as at least one of the 10 functional limitation items (items 1-9,11) being documented as on 'most/every day(s)' in the last month. A repeated-measure mixed effect model was used to analyze the change of MFPDI scores between groups adjusting for potential confounders.
RESULTS


A total of 413 patients with a mean age of 63.2 years (49.7% males) were enrolled and 340 completed the study. The mean MFPDI score was 22.8±7.3, with 23.7% participants having disabling foot pain at baseline. There were significant differences in MFPDI scores change between groups over 2 years, with more improvements in vitamin D group than in placebo group (-0.03 vs. 1.30, P=0.013) and more improvement in those maintaining sufficient vitamin D levels (n=226) than those who did not (n=114) (-0.09 vs. 2.19, P=0.001).
CONCLUSION


Vitamin D supplementation and maintenance of sufficient vitamin D levels may improve foot pain in those with knee OA.",2020,"There were significant differences in MFPDI scores change between groups over 2 years, with more improvements in vitamin D group than in placebo group (-0.03 vs. 1.30, P=0.013) and more improvement in those maintaining sufficient vitamin D levels (n=226) than those who did not (n=114) (-0.09 vs. 2.19, P=0.001).
","['413 patients with a mean age of 63.2 years (49.7% males) were enrolled and 340 completed the study', 'those with knee OA', 'patients with symptomatic knee osteoarthritis', 'Symptomatic knee OA patients with serum 25-hydroxyvitamin D levels between 12.5 nmol/L to 60 nmol/L', 'patients with symptomatic knee OA']","['vitamin D supplementation or maintaining sufficient vitamin D level', 'placebo', 'Vitamin D supplementation', 'vitamin D', 'VItamin D', 'vitamin D supplementation', 'vitamin D3 or placebo']","['vitamin D levels', 'Manchester Foot Pain and Disability Index (MFPDI', 'MFPDI scores change', 'disabling foot pain', 'mean MFPDI score', 'MFPDI scores', 'foot pain and Disabling foot pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960415', 'cui_str': 'Manchester foot pain and disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960416', 'cui_str': 'Manchester foot pain and disability index score'}]",413.0,0.502134,"There were significant differences in MFPDI scores change between groups over 2 years, with more improvements in vitamin D group than in placebo group (-0.03 vs. 1.30, P=0.013) and more improvement in those maintaining sufficient vitamin D levels (n=226) than those who did not (n=114) (-0.09 vs. 2.19, P=0.001).
","[{'ForeName': 'Liudan', 'Initials': 'L', 'LastName': 'Tu', 'Affiliation': 'Department of Rheumatology, the third Affiliated Hospital of SUN YAT-SEN University, Guangzhou, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'Xingzhong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Rheumatology, the third Affiliated Hospital of SUN YAT-SEN University, Guangzhou, China.'}, {'ForeName': 'Anita E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Department of Rheumatology, the third Affiliated Hospital of SUN YAT-SEN University, Guangzhou, China.'}]",Arthritis care & research,['10.1002/acr.24371']
1850,32623833,"Efficacy and Safety Results of Micellar Water, Cream and Serum for Rosacea in comparison to a control group.","BACKGROUND


Rosacea is a common inflammatory skin disorder with centrofacial erythema, flushing, telangiectasia, papules/pustules and possible ocular or phymatous manifestation. Patients' skin is particularly sensitive to chemical and physical stimuli leading to burning, stinging, dryness and skin tightness.
OBJECTIVE


Dermatological evaluation of the efficacy and safety of skin care products designed for centrofacial erythema in rosacea patients, in comparison to a control group using objective measurements. Rosacea symptoms (itching, tension, warmth, burning, dryness) and quality of life were examined.
METHODS


Sixty Caucasians with centrofacial erythema were enrolled in an eight-week prospective study, fifty of them exclusively using the study products (micellar water, cream and serum) with ten participants randomly assigned to a control group. Patients were evaluated at baseline (V0), at four weeks (V1) and at eight weeks (V2). Three-dimensional objective measurements (VECTRA ®  ) as well as standardized questionnaires were used.
RESULTS


Results were compared with the control group. A significant reduction of 16% in skin redness as indicated by VECTRA® analysis was seen in the intervention group comparing V0 to V2. Furthermore, rosacea associated symptoms diminished by 57.1%, while life quality of affected patients within the intervention group improved by 54.5% comparing V0 to V2 respectively.
CONCLUSIONS


A skin care regime suitable for sensitive and redness prone skin led to an enhanced clinical appearance, to a decrease of associated symptoms in rosacea patients and to an improved life quality.",2020,A significant reduction of 16% in skin redness as indicated by VECTRA® analysis was seen in the intervention group comparing V0 to V2.,"['rosacea patients', 'centrofacial erythema in rosacea patients', 'Sixty Caucasians with centrofacial erythema were enrolled in an eight-week prospective study, fifty of them exclusively using the study products (micellar water, cream and serum) with ten participants randomly assigned to a control group']","['Micellar Water, Cream', 'skin care products']","['life quality', 'Furthermore, rosacea associated symptoms', 'skin redness', 'Rosacea symptoms (itching, tension, warmth, burning, dryness) and quality of life']","[{'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]",60.0,0.0224167,A significant reduction of 16% in skin redness as indicated by VECTRA® analysis was seen in the intervention group comparing V0 to V2.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guertler', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital of Munich, LMU, Munich, Germany.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Jøntvedt', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital of Munich, LMU, Munich, Germany.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Clanner-Engelshofen', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital of Munich, LMU, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cappello', 'Affiliation': 'LETI Pharma GmbH, Ismaning, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sager', 'Affiliation': 'LETI Pharma GmbH, Ismaning, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reinholz', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital of Munich, LMU, Munich, Germany.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13591']
1851,32623839,"Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Sub-analysis of a prospective, randomized, controlled study (PRIME-V study).","INTRODUCTION


Recent randomized clinical trials have suggested that sodium-glucose co-transporter-2 (SGLT2) inhibitors may reduce cardiovascular events and heart failure and have renal protective effects. Despite these remarkable benefits, the effects of SGLT2 inhibitors on bone and muscle are unclear.
METHODS


A sub-analysis of a randomized controlled study was performed to evaluate the effects of the SGLT2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline BMI ≥ 22 kg/m 2  and HbA1c 7-10 %) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1000-1500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase (BAP); the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated.
RESULTS


After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength, and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared to patients treated with metformin (median 11.94 % vs. -10.30 %, P < 0.0001), indicating that ipragliflozin can promote bone resorption.
CONCLUSIONS


There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is needed to further understand the effects of this TRACP-5b increase caused by ipragliflozin.
CLINICAL TRIAL REGISTRATION


http://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).",2020,There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin.,"['Japanese patients with type 2 diabetes mellitus', 'Japanese patients with type 2 diabetes mellitus (baseline BMI ≥ 22 kg/m 2  and HbA1c 7-10 %) who were already receiving sitagliptin']","['SGLT2 inhibitors', 'SGLT2 inhibitor, ipragliflozin, versus metformin', 'sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'metformin', 'ipragliflozin versus metformin', 'sitagliptin', 'ipragliflozin or metformin', 'ipragliflozin', 'ipragliflozin 50 mg or metformin', 'TRACP-5b']","['TRACP-5b levels', 'cardiovascular events and heart failure', 'levels of TRACP-5b', 'bone resorption', 'bone density of the fourth lumbar vertebra, handgrip strength, and abdominal cross-sectional muscle area', 'bone formation marker, bone alkali phosphatase (BAP); the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0223537', 'cui_str': 'Bone structure of L4'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031678', 'cui_str': 'Phosphoric monoester hydrolase'}]",,0.0658579,There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin.,"[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Koshizaka', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Ishibashi', 'Initials': 'I', 'LastName': 'Ryoichi', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Maezawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Daigaku', 'Initials': 'D', 'LastName': 'Uchida', 'Affiliation': 'Hotaruno Central Naika, 3-30-3 Hotaruno, Kisarazu City, Chiba, 292-0038, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Odayama Clinic, 3-2-2 Ota, Kisarazu City, Chiba, 292-0044, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Yamaga', 'Affiliation': 'Department of Diabetes and Metabolism, Japanese Red Cross Narita Hospital, 90-1 Iida-cho, Narita City, Chiba, 286-8523, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Yokoh', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Akina', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Onishi', 'Affiliation': 'Department of Diabetes and Metabolism, Asahi General Hospital, 1326 I, Asahi City, Chiba, 289-2511, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ogino', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, 477-96 Owadashinden, Yachiyo City, Chiba, 276-8524, Japan.""}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, 477-96 Owadashinden, Yachiyo City, Chiba, 276-8524, Japan.""}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Yukarigaoka Tokuyama Medical Clinic, 7-2-2 Nishi-Yukarigaoka, Sakura City, Chiba, 285-0850, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Shimada', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, 4-1-2 Tsubakimori, Chuo-ku, Chiba City, Chiba, 260-8606, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Ohara', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, 4-1-2 Tsubakimori, Chuo-ku, Chiba City, Chiba, 260-8606, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Shoji', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ide', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kitamoto', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Horikoshi', 'Affiliation': 'Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.'}, {'ForeName': 'Ryouta', 'Initials': 'R', 'LastName': 'Shimofusa', 'Affiliation': 'Department of Radiology, Sannou Hospital, 166-2 Sannou-chou, Inage-ku, Chiba City, Chiba, 263-0002, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare, 4-3 Kozunomori, Narita City, Chiba, 286-0048, Japan.'}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC, 27715, USA.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13340']
1852,32623947,"Is ""Response/No Response"" Too Simple a Notion for RTI Frameworks? Exploring Multiple Response Types With Latent Profile Analysis.","We conducted a secondary analysis of data from a randomized control trial to explore this question: Does ""response/no response"" best characterize students' reactions to a generally efficacious first-grade reading program, or is a more nuanced characterization necessary? Data were collected on 265 at-risk readers' word reading prior to and immediately following program implementation in first grade and in spring of second grade. Pretreatment data were also obtained on domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning). Latent profile analysis of word reading across the three time points with controls as a local norm revealed a  strongly responsive  group ( n  = 45) with mean word-reading  z  scores of 0.25, 1.64, and 1.26 at the three time points, respectively; a  mildly responsive  group ( n  = 109),  z  scores = 0.30, 0.47, and 0.55; a  mildly non-responsive  group ( n  = 90),  z  scores = -0.11, -0.15, and -0.55; and a  strongly non-responsive  group ( n  = 21),  z  scores = -1.24, -1.26, and -1.57. The two responsive groups had stronger pretreatment letter knowledge and passage comprehension than the two non-responsive groups. The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group. No domain-general skill distinguished the four groups. Findings suggest response to early reading intervention was more complicated than response/no response, and pretreatment reading comprehension was an important predictor of response even with pretreatment word reading controlled.",2020,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,[],[],"['Response', 'pretreatment passage comprehension', 'stronger pretreatment letter knowledge and passage comprehension', 'domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning']",[],[],"[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0174433,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Peng', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Michigan State University, East Lansing, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Elleman', 'Affiliation': 'Middle Tennessee State University, Mufreesboro, USA.'}, {'ForeName': 'Devin M', 'Initials': 'DM', 'LastName': 'Kearns', 'Affiliation': 'University of Connecticut, Storrs, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Patton', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Compton', 'Affiliation': 'Florida State University, Tallahassee, USA.'}]",Journal of learning disabilities,['10.1177/0022219420931818']
1853,32623958,Effect of Standing on a Standardized Measure of Upper Extremity Function.,"Although many daily activities that require the upper extremity are performed in standing, arm motor function is generally measured in sitting. The purpose of this study was to examine the effect of standing on a measure of upper extremity function, the Jebsen Hand Function Test (JHFT). Twelve nondisabled adults (26.3 ± 3.1 years) completed the JHFT with the right and left arms under two conditions: sitting and standing. Total time to complete the JHFT increased when performed in standing compared with sitting in both arms ( p  = .005); mean increase was 4.4% and 5.6% for the right and left arms, respectively. Checker stacking was the only subtest that showed a significant increase in completion time in standing for both arms ( p  = .001); card turning showed an increase for the left arm only ( p  = .002). Measurement of upper extremity function in standing may provide insight into arm motor capacity within the context of standing postural control demands.",2020,"Total time to complete the JHFT increased when performed in standing compared with sitting in both arms ( p  = .005); mean increase was 4.4% and 5.6% for the right and left arms, respectively.",['Twelve nondisabled adults (26.3 ± 3.1 years) completed the JHFT with the right and left arms under two conditions: sitting and standing'],[],"['Total time to complete the JHFT', 'upper extremity function, the Jebsen Hand Function Test (JHFT', 'completion time in standing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451237', 'cui_str': 'Jebsen hand function test'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451237', 'cui_str': 'Jebsen hand function test'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",12.0,0.0264381,"Total time to complete the JHFT increased when performed in standing compared with sitting in both arms ( p  = .005); mean increase was 4.4% and 5.6% for the right and left arms, respectively.","[{'ForeName': 'Jill Campbell', 'Initials': 'JC', 'LastName': 'Stewart', 'Affiliation': 'University of South Carolina, Columbia, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Saba', 'Affiliation': 'University of South Carolina, Columbia, USA.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Baird', 'Affiliation': 'University of South Carolina, Columbia, USA.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Kolar', 'Affiliation': 'University of South Carolina, Columbia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Donnell"", 'Affiliation': 'University of South Carolina, Columbia, USA.'}, {'ForeName': 'Sydney Y', 'Initials': 'SY', 'LastName': 'Schaefer', 'Affiliation': 'Arizona State University, Tempe, USA.'}]","OTJR : occupation, participation and health",['10.1177/1539449220937058']
1854,32624244,"Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results.","PURPOSE


To examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS).
DESIGN


Phase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186).
PARTICIPANTS


Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids.
METHODS


Participants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment.
MAIN OUTCOME MEASURES


The primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments.
RESULTS


One hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P < 0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P < 0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively).
CONCLUSIONS


Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.",2020,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","['One hundred twenty-nine participants (n\xa0= 87', 'Participants', 'Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids', 'FAi-treated; n\xa0= 42 sham-treated) were enrolled']","['Fluocinolone acetonide', 'FAi or sham (injection plus standard of care) treatment', 'fluocinolone acetonide insert (FAi', 'Fluocinolone Acetonide', 'FAi']","['time to first recurrence', 'Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis', 'time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments', 'macular edema', 'uveitis recurrence', 'cumulative uveitis recurrences', 'number of recurrences per eye', 'BCVA', 'Intraocular pressure (IOP', 'recurrence-free durations, fewer recurrence episodes', 'uveitis recurrence rates', '36-month efficacy and safety', 'Cataract surgery']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]",129.0,0.488521,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","[{'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Eye Center, Duke University, Durham, North Carolina. Electronic address: jaffe001@mc.duke.edu.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Pavesio', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.04.001']
1855,32624277,"Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study.",,2020,,['Patients with High-risk Prostate Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0420324,,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Ploussard', 'Affiliation': 'Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France. Electronic address: g.ploussard@gmail.com.'}]",European urology,['10.1016/j.eururo.2020.06.017']
1856,32624282,"Erratum to 'Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received' [European Urology 77 (2020) 320-330].",,2020,,['Men with Localised Prostate Cancer'],[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0635376,,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.05.030']
1857,32624365,Could self-locking stand-alone cage reduce adjacent-level ossification development after aneterior cervical discectomy and fusion?,"Numerous studies have shown that cervical arthrodesis is associated with the adjacent-segment pathology (ASP), such as adjacent-level ossification development (ALOD). However, it still remains largely unclear whether the self-locking stand-alone implant system can reduce the incidence of ALOD. In the present study, we prospectively recruited 120 patients with cervical degenerative disc disease (CDDD) who were treated by anterior cervical discectomy and fusion (ACDF). These patients were randomly and evenly divided into the ROI-C group and plate group. Clinical and radiologic follow-up was performed at 3, 6, 12, 24 and 36 months after surgery. Clinical evaluation included preoperative and postoperative assessments of Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score. The presence and severity of ALOD, as well as the C2-7 Cobb angle, were assessed on the lateral cervical films during follow-up. There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups. ALOD occurred in 8.8% of 58 patients and 6.7% of 104 levels in the cage group. Moreover, ALOD occurred in 20.1% of 57 patients and 17.8% of 101 levels in the plate group. The ALOD was more serious in the plate group compared with the cage group. The C2-7 Cobb angle was significantly improved compared with that before the operation and could be maintained during the follow-up in both groups. The self-locking stand-alone cage was efficacious for ACDF, and it could reduce the incidence of ALOD compared with anterior plate and cage.",2020,There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups.,['120 patients with cervical degenerative disc disease (CDDD) who were treated by anterior cervical discectomy and fusion (ACDF'],[],"['JOA and NDI scores', 'Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score', 'ALOD']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]",[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",120.0,0.0182449,There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xilei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China. Electronic address: zhou.xiaogang@zs-hospital.sh.cn.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.014']
1858,32624375,Effectiveness of ginger on pain following periodontal surgery - A randomized cross over clinical trial.,"BACKGROUND


Ibuprofen is one of the generally prescribed Non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain after periodontal surgery, but are contraindicated in certain patients. Ginger, which is the rhizome of Zingiber officinale, being a common herbal drug having anti-inflammatory as well as analgesic activities can be an efficient substitute for synthetic agents like Ibuprofen.
OBJECTIVES


To compare the effectiveness of ibuprofen and dried ginger powder on pain and gingival inflammation following open flap debridement.
MATERIALS AND METHODS


Ten systemically healthy individuals with chronic generalized periodontitis were selected for this single-blinded randomized cross-over clinical trial and underwent open flap debridement in at least two quadrants. Each quadrant was randomly allocated to receive either Ibuprofen (400 mg) or Ginger powder capsules (400 mg) thrice daily for three days. Subjects were requested to note down the pain score on the Visual Analogue Scale (VAS) provided in a printed format, for the first eight hours after surgery and on the following two days, and gingival inflammation was assessed after one week, using Modified Gingival Index (MGI).
RESULT


The difference in the VAS score and MGI between the two groups was not of statistical significance.
CONCLUSION


Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.",2020,Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.,['Ten systemically healthy individuals with chronic generalized periodontitis'],"['ibuprofen', 'ibuprofen and dried ginger powder', 'Ginger powder capsules', 'Ibuprofen', 'ginger', 'ginger powder', 'open flap debridement']","['pain and gingival inflammation', 'pain score on the Visual Analogue Scale (VAS', 'VAS score and MGI', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",10.0,0.224003,Effectiveness of ginger powder for the management of pain and gingival inflammation following open flap debridement is comparable to that of ibuprofen.,"[{'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Menon', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: menon.pallavi.92@gmail.com.'}, {'ForeName': 'Jayachandran', 'Initials': 'J', 'LastName': 'Perayil', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: jayachandranp@aims.amrita.edu.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Fenol', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: angelfenol@aims.amrita.edu.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rajan Peter', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: mayageorge_2000@yahoo.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Periodontics, Manipal Academy of Higher Education, Manipal, India. Electronic address: lakshmi.p.menon83@gmail.com.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Suresh', 'Affiliation': 'Department of Periodontics, Amrita School of Dentistry, Kochi, Amrita Vishwa Vidyapeetham, India. Electronic address: resh.doc53@gmail.com.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.05.003']
1859,32624377,"Transdermal buprenorphine patch versus oral celecoxib for pain management after total knee arthroplasty: An open- label, randomized controlled trial.","BACKGROUND


This study was performed to evaluate the analgesic efficacy and safety of transdermal buprenorphine (TDB) patched for post-operative pain control after total knee arthroplasty (TKA). The hypothesis was that patients receiving the TDB patch would have less pain in comparison to those treated with the oral COX-2 inhibitor celecoxib without increasing side effects.
PATIENTS AND METHODS


A total of 160 patients scheduled for primary TKA were randomly assigned to two groups: patients provided the TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group). The outcomes were pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively.
RESULTS


The total morphine given during the first 72h post-operatively was significantly lower in the TDB group than CX group. The VAS scores were significantly lower in the TDB group than CX group during rest at 2, 4, 6, 12, 24 and 48h post-operatively, and during activity at 12, 24 and 48h and 3 days post-operatively. The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group. In addition, the Lysholm score was significantly higher in the TDB group on PD 3. There were no remarkable adverse events in either group.
DISCUSSION


Use of the TDB patch provides effective pain relief and reduces the requirement for rescue morphine without increasing side effects in comparison with oral celecoxib during the early post-operative stage following TKA.
LEVEL OF EVIDENCE


II.",2020,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","['160 patients scheduled for primary TKA', 'pain management after total knee arthroplasty']","['Transdermal buprenorphine patch versus oral celecoxib', 'TDB', 'oral COX-2 inhibitor celecoxib', 'TDB patch', 'celecoxib', 'transdermal buprenorphine', 'TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group', 'CX']","['mean range of motion on post-operative days (PD', 'Lysholm score', 'analgesic efficacy and safety', 'effective pain relief', 'adverse events', 'pain', 'pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively', 'VAS scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",160.0,0.0687527,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'The Radiology Department of Wenzhou Seventh Hospital, Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Haixiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China. Electronic address: huyuezheng3@163.com.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.010']
1860,32624400,Better timing of ultrasound-guided transversus abdominis plane block for early recovery after open inguinal herniorrhaphy: A prospective randomised controlled study.,"BACKGROUND


This study investigated the optimal timing of analgesic transversus abdominis plane (TAP) block in the operating room for better recovery quality using the Korean version of the Quality of Recovery-40 (QoR-40K) questionnaire in patients who had undergone open inguinal herniorrhaphy.
METHODS


This single-centre, prospective randomised controlled study included adult male patients who had an ASA physical status of I-II. A total of 80 patients were analysed. The patients were randomly assigned and classified into pre-incisional TAP (pre-TAP) block (n = 40) and post-incisional TAP (post-TAP) block (n = 40) groups. The quality of postoperative functional recovery and complications were compared between the two groups during 24 h postoperatively.
RESULTS


Preoperative findings of the two groups were comparable. The global QoR-40K score was higher in the pre-TAP group than in the post-TAP group. Among sub-dimensions, scores of physical comfort and pain were higher in the pre-TAP group than in the post-TAP group. In the post-anaesthesia care unit, the pre-TAP group showed lower pain scores than the post-TAP block group. There was no severe pain in the pre-TAP group, but two patients (5.0%) in the post-TAP block group suffered severe pain. The pre-TAP group required lower doses of IV rescue opioid in the PACU than the post-TAP group. All patients were discharged from hospital on postoperative day 1 without surgical complications.
CONCLUSIONS


The timing of analgesic TAP block may be of clinical importance to prevent postoperative pain and to improve the quality of early patient recovery following open inguinal herniorrhaphy.",2020,The global QoR-40K score was higher in the pre-TAP group than in the post-TAP group.,"['A total of 80 patients were analysed', 'n\xa0=\xa040', 'early recovery after open inguinal herniorrhaphy', 'All patients were discharged from hospital on postoperative day 1 without surgical complications', 'patients who had undergone open inguinal herniorrhaphy', 'adult male patients who had an ASA physical status of I-II']","['ultrasound-guided transversus abdominis plane block', 'incisional TAP (pre-TAP) block (n\xa0=\xa040) and post-incisional TAP (post-TAP) block ', 'analgesic transversus abdominis plane (TAP) block']","['pain scores', 'scores of physical comfort and pain', 'Quality of Recovery-40 (QoR-40K) questionnaire', 'severe pain', 'quality of postoperative functional recovery and complications', 'global QoR-40K score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",80.0,0.0849284,The global QoR-40K score was higher in the pre-TAP group than in the post-TAP group.,"[{'ForeName': 'Jung-Woo', 'Initials': 'JW', 'LastName': 'Shim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jemin', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chul-Seung', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Do-Sang', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jaesik', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyung Mook', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong-Suk', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Young Eun', 'Initials': 'YE', 'LastName': 'Moon', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Min Suk', 'Initials': 'MS', 'LastName': 'Chae', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: shscms@gmail.com.""}]",Asian journal of surgery,['10.1016/j.asjsur.2020.06.001']
1861,32624429,Effect of Prior Formal Education on Successful Thoracic Epidural Placement By Anesthesia Residents.,"OBJECTIVE


Catheter placement for thoracic epidural analgesia (TEA) is technically challenging; however, methods for teaching this technique to anesthesia residents have not been well-studied. The present study aimed to determine optimal teaching methods for proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training by attending physicians.
DESIGN


Prospective, randomized study.
SETTING


Large academic hospital, single institution.
PARTICIPANTS


The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control).
INTERVENTIONS


Formal education included an instructional video on proper TEA technique.
MEASUREMENTS AND MAIN RESULTS


Measures of proficiency in TEA catheter placement included the time needed to complete the procedure successfully and the success of placement as indicated by patient confirmation. Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents. The overall success rate was 99.2%, with faculty intervention required in only 17% of cases. More experienced residents (ie, having placed more epidural catheters) were faster at TEA catheter placement.
CONCLUSIONS


Formal video education for TEA catheter placement provided no additional improvement of resident proficiency compared with traditional training at a high-volume academic center. The success rate was very high in this group of residents; however, experiences at other institutions may vary. Future studies are needed to determine optimum teaching strategies for TEA.",2020,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"['Large academic hospital, single institution', 'The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control', 'Successful Thoracic Epidural Placement By Anesthesia Residents']","['Prior Formal Education', 'Formal education included an instructional video on proper TEA technique', 'TEA catheter placement', 'proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training', 'Catheter placement for thoracic epidural analgesia (TEA', 'formal video instruction']","['time needed to complete the procedure successfully and the success of placement', 'success rate', 'overall success rate']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.072334,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"[{'ForeName': 'Yar Luan', 'Initials': 'YL', 'LastName': 'Yeap', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN. Electronic address: yyeap@iupui.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Lemmon', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Mann', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wolfe', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.023']
1862,32624443,A More Comfortable Method of Skin Prick Testing in Children Ages 0-2 to Decrease Symptoms of Pain.,"BACKGROUND


Skin prick testing (SPT) is the best initial diagnostic method for individuals of all ages who have potential allergies.
AIM


We aimed to investigate if recent breastfeeding has any effect on reducing the pain of children before SPT.
DESIGN


Prospective, randomized, single-blinded study.
SETTINGS


Academic hospital specialized in pediatrics.
PARTICIPANTS/SUBJECTS


Sixty-four out of seventy-five children requiring SPT within ages 0-2 were included.
METHODS


All participants in this study were breastfed children, and that group assignment randomized them to the control group (n = 32) if children breastfed 30-90 min. prior to arriving for SPT, and study group of children (n = 32) who were also breastfed 30-90 minutes prior to arriving for SPT who were then breastfed again just prior to the beginning of the SPT. The FLACC pain scale was used to test the sensitivity of all children for pain before, during, and 15 minutes after the SPT. The effect of breastfeeding on the pain score and the duration of crying were compared among groups.
RESULTS


Both groups were similar according to age, gender, and other socio-demographic characteristics (p > .05). The percentage of children that cried during SPT was significantly higher in the control group than the study group (p = .002). The FLACC pain scale values were significantly lower in the study group (p < .001).
CONCLUSION


Recent breastfeeding before SPT is correlated with less crying by possibly reducing the perceived pain of children ages 0-2.",2020,"The FLACC pain scale values were significantly lower in the study group (p < .001).
","['individuals of all ages who have potential allergies', 'Academic hospital specialized in pediatrics', 'Sixty-four out of seventy-five children requiring SPT within ages 0-2 were included']",['Skin prick testing (SPT'],"['pain score and the duration of crying', 'Symptoms of Pain', 'percentage of children that cried during SPT', 'FLACC pain scale values', 'FLACC\xa0pain scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",75.0,0.0351259,"The FLACC pain scale values were significantly lower in the study group (p < .001).
","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Ercan', 'Affiliation': 'University of Health Sciences, Ankara, Turkey. Electronic address: drnazliercan@gmail.com.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Bostanci', 'Affiliation': 'University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Gülay', 'Initials': 'G', 'LastName': 'Şenel', 'Affiliation': 'University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Özmen', 'Affiliation': 'University of Health Sciences, Ankara, Turkey.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.05.008']
1863,32624444,Early urinary sodium trajectory and risk of adverse outcomes in acute heart failure and renal dysfunction.,"INTRODUCTION AND OBJECTIVES


Urinary sodium (UNa + ) has emerged as a useful biomarker of poor clinical outcomes in acute heart failure (AHF). Here, we sought to evaluate: a) the usefulness of a single early determination of UNa +  for predicting adverse outcomes in patients with AHF and renal dysfunction, and b) whether the change in UNa +  at 24hours (ΔUNa24h) adds any additional prognostic information over baseline values.
METHODS


This is a post-hoc analysis of a multicenter, open-label, randomized clinical trial (IMPROVE-HF) (ClinicalTrials.gov NCT02643147) that randomized 160 patients with AHF and renal dysfunction on admission to a) the standard diuretic strategy, or b) a carbohydrate antigen 125-guided diuretic strategy. The primary end point was all-cause mortality and total all-cause readmissions.
RESULTS


The mean age was 78±8 years, and the mean glomerular filtration rate was 34.0±8.5mL/min/1.73 m 2 . The median UNa +  was 90 (65-111) mmol/L. At a median follow-up of 1.73 years [interquartile range, 0.48-2.35], 83 deaths (51.9%) were registered, as well as 263 all-cause readmissions in 110 patients. UNa +  was independently associated with mortality (HR, 0.75; 95%CI, 0.65-0.87; P <.001) and all-cause readmissions (HR, 0.92; 95%CI, 0.88-0.96; P <.001). The prognostic usefulness of the ΔUNa24h varied according to UNa +  at admission (P for interaction <.05). The ΔUNa24h was inversely associated with both end points only in the group with UNa +  ≤ 50 mmol/L. Conversely, no effect was found in the group with UNa + > 50 mmol/L.
CONCLUSIONS


In patients with AHF and renal dysfunction, a single early determination of UNa +  ≤ 50 mmol/L identifies patients with a higher risk of all-cause mortality and readmission. The ΔUNa24h adds prognostic information over baseline values only when UNa +  at admission is ≤ 50 mmol/L.",2020,The prognostic usefulness of the ΔUNa24h varied according to UNa +  at admission (P for interaction <.05).,"['patients with AHF and renal dysfunction', 'acute heart failure (AHF', 'acute heart failure and renal dysfunction', '160 patients with AHF and renal dysfunction on admission to a) the standard diuretic strategy, or b) a carbohydrate antigen 125-guided diuretic strategy', 'patients with AHF and renal dysfunction, and b']",['UNa '],"['ΔUNa24h', 'cause mortality and total all-cause readmissions', 'mean glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",160.0,0.106107,The prognostic usefulness of the ΔUNa24h varied according to UNa +  at admission (P for interaction <.05).,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Espriella', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Llàcer', 'Affiliation': 'Servicio de Medicina Interna, Hospital de Manises, Manises, Valencia, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'García-Blas', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ventura', 'Affiliation': 'Servicio de Medicina Interna, Hospital de La Plana, Villa-Real, Castellón, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Núñez', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Universitario del Vinalopó, Elche, Alicante, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Sánchez', 'Affiliation': 'Servicio de Medicina Interna, Hospital Virgen de Los Lirios, Alcoy, Alicante, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Fácila', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Juana María', 'Initials': 'JM', 'LastName': 'Vaquer', 'Affiliation': 'Servicio de Bioquímica, Hospital Clínico Universitario de Valencia, Universidad de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Bodí', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Santas', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mollar', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Chorro', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Górriz', 'Affiliation': 'Servicio de Nefrología, Hospital Clínico Universitario de Valencia, Universidad de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sanchis', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genis', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Servicio de Cardiología y Unidad de Insuficiencia Cardiaca, Hospital Universitari Germans Trias i Pujol, Departamento de Medicina, Universidad Autónoma de Barcelona, Badalona, Barcelona, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Universitat de Valencia, Fundación Investigación Clínico de Valencia - Instituto de Investigación Sanitaria (INCLIVA), Valencia, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain. Electronic address: yulnunez@gmail.com.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.06.004']
1864,32624452,Physical activity and motor skill outcomes of a 10-week intervention for children with intellectual and developmental disabilities ages 4-13: A pilot study.,"BACKGROUND


Children with intellectual and developmental disabilities (IDD) often experience increased barriers to engaging in physical activity (PA) which can stem from lack of gross motor function (GMF) development. Intervening on GMF at an early age can create better opportunities for children with IDD to engage in regular PA. In turn, increased PA can improve health outcomes and increase social skills.
OBJECTIVE


The primary objective of this pilot study was to explore the effectiveness of a community-based GMF-focused PA intervention for improving overall motor skills and PA for children with IDD.
METHODS


All study participants (n = 24) engaged in 10 weeks of programming for 1 h each week. A convenience sample was utilized.
RESULTS


Results indicated no statistically significant changes pre to post for motor skill scores. However, a visual analysis of mean changes showed a consistent pattern of increased scores from pre to post on most skills. Additionally, we found that a change in participant locomotor skills significantly predicted change in Moderate to Vigorous Physical Activity (MVPA), F (1,11) = 5.16, Adj R 2  = .26, p = .04.
CONCLUSIONS


These results suggest individualized attention on GMF may help to increase motor skills for children with IDD. This study adds to the small but growing amount of research examining the efficacy of community based adapted PA interventions. Further, study results should support continued exploration of effective approaches to address the motor delays experienced by children with IDD.",2020,"RESULTS


Results indicated no statistically significant changes pre to post for motor skill scores.","['Children with intellectual and developmental disabilities (IDD', 'children with IDD to engage in regular PA', 'All study participants (n\xa0=\xa024) engaged in 10 weeks of programming for 1\xa0h each week', 'children with intellectual and developmental disabilities ages 4-13', 'children with IDD']",['community-based GMF-focused PA intervention'],"['Moderate to Vigorous Physical Activity (MVPA', 'Physical activity and motor skill outcomes', 'motor skills', 'motor skill scores', 'health outcomes and increase social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",24.0,0.0247027,"RESULTS


Results indicated no statistically significant changes pre to post for motor skill scores.","[{'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Ketcheson', 'Affiliation': 'Wayne State University, United States. Electronic address: leah.ketcheson@wayne.edu.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Centeio', 'Affiliation': 'University of Hawaii at Manoa, United States.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Snapp', 'Affiliation': 'Wayne State University, United States.'}, {'ForeName': 'Hayley B', 'Initials': 'HB', 'LastName': 'McKown', 'Affiliation': 'University of Hawaii at Manoa, United States.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Martin', 'Affiliation': 'Wayne State University, United States.'}]",Disability and health journal,['10.1016/j.dhjo.2020.100952']
1865,32624460,Angiographic predictors of outcome in myocardial infarction patients presenting with cardiogenic shock: A CULPRIT-SHOCK angiographic substudy.,"AIMS


To determine the prognostic impact of pre and post-PCI TIMI Flow Grade (TIMI) and TIMI Myocardial Perfusion (TMPG) in a well-defined group of patients with cardiogenic shock due to acute myocardial infarction.
METHODS AND RESULTS


Patients with infarct-related cardiogenic shock randomized into the CULPRIT-SHOCK trial were included in the angiographic predictor analysis whenever their TIMI or TMPG was available in the Corelab database (96.9% of cases). A multivariable logistic regression analysis, adjusted on non-angiographic covariates, was performed to investigate if TIMI or TMPG, were independently associated with all-cause mortality or renal replacement therapy up to 1 year. Pre-PCI TIMI and TMPG did not impact mortality. When analyzed in separate multivariable models, post-PCI TIMI 3 and TMPG grade 3 were both significantly associated with reduced risk of 30-day mortality: aOR 0.61 (95%CI: 0.38-0.97, p=0.037) and 0.46 (95%CI: 0.29-0.72, p&lt;0.001), respectively. When considered in the same multivariable model, only TMPG was significantly associated with 30-day mortality (aOR 0.38 [0.20-0.71], p=0.002), 30-day composite of all-cause mortality and renal replacement therapy (aOR 0.34 [0.18-0.66], p=0.001) and mortality at 1-year follow-up (aOR 0.46 [0.24-0.88], p=0.02).
CONCLUSIONS


Post-PCI TIMI and TMPG are associated with mortality after PCI. TMPG is a better discriminator, supporting microcirculation rather than epicardial reperfusion for prognosis estimation.",2020,Pre-PCI TIMI and TMPG did not impact mortality.,"['patients with cardiogenic shock due to acute myocardial infarction', 'Patients with infarct-related cardiogenic shock randomized into the CULPRIT-SHOCK trial were included in the angiographic predictor analysis whenever their TIMI or TMPG was available in the Corelab database (96.9% of cases', 'myocardial infarction patients presenting with cardiogenic shock']",['TMPG'],"['reduced risk of 30-day mortality', 'prognostic impact of pre and post-PCI TIMI Flow Grade (TIMI) and TIMI Myocardial Perfusion (TMPG', 'mortality', '30-day composite of all-cause mortality and renal replacement therapy', '30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0642334', 'cui_str': 'N(2)-(3-trifluoromethylphenyl)guanine'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0642334', 'cui_str': 'N(2)-(3-trifluoromethylphenyl)guanine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",,0.198317,Pre-PCI TIMI and TMPG did not impact mortality.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Overtchouk', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olvier', 'Initials': 'O', 'LastName': 'Barthelemy', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': ''}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': ''}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': ''}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': ''}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00139']
1866,32624468,Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors.,"INTRODUCTION


The eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.
METHODS AND ANALYSIS


This is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app ('Be-with-You'), while the control group will use a general health app ('Sham' app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.
ETHICS AND DISSEMINATION


The Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.
TRIAL REGISTRATION NUMBER


ChiCTR1900026244.",2020,"The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills.","['breast cancer survivors', 'Eligible participants']","[""self-management app ('Be-with-You'), while the control group will use a general health app ('Sham' app"", 'self-management application (app']","['self-efficacy, readiness for change and health-related quality of life', 'health literacy, problem-solving skills and self-management skills']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.111542,"The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills.","[{'ForeName': 'Andy S K', 'Initials': 'ASK', 'LastName': 'Cheng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong andy.cheng@polyu.edu.hk.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Peter H F', 'Initials': 'PHF', 'LastName': 'Ng', 'Affiliation': 'Department of Computing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Cindy T T', 'Initials': 'CTT', 'LastName': 'Kwok', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Feuerstein', 'Affiliation': 'Consultant in Cancer Survivorship, Gaithersburg, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034655']
1867,32624472,"Is reduction of routine radiograph use in patients with distal radius fractures cost effective? Analysis of data from the multicentre, randomised controlled WARRIOR trial.","OBJECTIVE


To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care.
DESIGN


An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT).
SETTING


Four level-one trauma centres in the Netherlands.
PARTICIPANTS


341 patients participated (usual care (n=172), reduced imaging (n=169)).
INTERVENTIONS


Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication).
OUTCOME MEASURES


Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data.
RESULTS


Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (€-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY.
CONCLUSIONS


Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated.
TRIAL REGISTRATION NUMBER


The Netherlands trial register (NL4477).",2020,"Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome.","['341 patients participated (usual care (n=172), reduced imaging (n=169', 'patients with distal radius fractures', 'Four level-one trauma centres in the Netherlands']","['usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication']","['total costs', 'Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L', 'DASH', 'cost effectiveness', 'Costs for radiographic imaging', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0457276', 'cui_str': 'Radiographic imaging - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",341.0,0.158822,"Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands p.van_gerven@lumc.nl.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Trauma Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wietse P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Trauma Surgery, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Pieta', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Inger B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035370']
1868,32624473,Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial.,"INTRODUCTION


Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.
METHODS AND ANALYSIS


We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.
ETHICS AND DISSEMINATION


This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.
TRIAL REGISTRATION NUMBER


NCT03936504.",2020,"The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination.","['chronic coronary syndrom patients', '150 participants with CCS', 'patients with chronic coronary syndrom (CCS']","['innovative Tai Chi Cardiac Rehabilitation Program (TCCRP', 'supervised conventional exercise rehabilitation', 'Tai Chi-based cardiac rehabilitation programme', 'Tai Chi exercise']","['body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination', 'Safety and effectiveness', 'Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale', 'efficacy, safety and acceptability', 'score of 36-Item Short Form Survey and Chinese Perceived Stress Scale']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C1997846', 'cui_str': 'Heart rate recovery time'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",150.0,0.127198,"The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiology, First Medical Center of Chinese People's Libration Army General Hospital, Beijing, China.""}, {'ForeName': 'Jian Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, Anzhen Community Health Service Center, Chaoyang District, Beijing, China.'}, {'ForeName': 'Lian Shan', 'Initials': 'LS', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Medicine, Beijing Shuili Hospital, Beijing, China.'}, {'ForeName': 'Ai Ying', 'Initials': 'AY', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiovascular Medicine, Anzhen Community Health Service Center, Chaoyang District, Beijing, China.'}, {'ForeName': 'Zai Hao', 'Initials': 'ZH', 'LastName': 'Chen', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Tian Ming', 'Initials': 'TM', 'LastName': 'Gao', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Ya Meng', 'Initials': 'YM', 'LastName': 'Li', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Cui Han', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Hong Wei', 'Initials': 'HW', 'LastName': 'Wang', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Yu Long', 'Initials': 'YL', 'LastName': 'Lu', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Mei Ze', 'Initials': 'MZ', 'LastName': 'Cui', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Qiu Yang', 'Initials': 'QY', 'LastName': 'Wei', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shao Jun', 'Initials': 'SJ', 'LastName': 'Lyu', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China l13121860699@163.com shaojunl@hotmail.com yinhengchan@bnu.edu.cn.'}, {'ForeName': 'Heng Chan', 'Initials': 'HC', 'LastName': 'Yin', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China l13121860699@163.com shaojunl@hotmail.com yinhengchan@bnu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-036061']
1869,32624568,Exercise training modulates the gut microbiota profile and impairs inflammatory signaling pathways in obese children.,"Childhood obesity has reached epidemic levels and is a serious health concern associated with metabolic syndrome, nonalcoholic fatty liver disease, and gut microbiota alterations. Physical exercise is known to counteract obesity progression and modulate the gut microbiota composition. This study aims to determine the effect of a 12-week strength and endurance combined training program on gut microbiota and inflammation in obese pediatric patients. Thirty-nine obese children were assigned randomly to the control or training group. Anthropometric and biochemical parameters, muscular strength, and inflammatory signaling pathways in mononuclear cells were evaluated. Bacterial composition and functionality were determined by massive sequencing and metabolomic analysis. Exercise reduced plasma glucose levels and increased dynamic strength in the upper and lower extremities compared with the obese control group. Metagenomic analysis revealed a bacterial composition associated with obesity, showing changes at the phylum, class, and genus levels. Exercise counteracted this profile, significantly reducing the Proteobacteria phylum and Gammaproteobacteria class. Moreover, physical activity tended to increase some genera, such as Blautia, Dialister, and Roseburia, leading to a microbiota profile similar to that of healthy children. Metabolomic analysis revealed changes in short-chain fatty acids, branched-chain amino acids, and several sugars in response to exercise, in correlation with a specific microbiota profile. Finally, the training protocol significantly inhibited the activation of the obesity-associated NLRP3 signaling pathway. Our data suggest the existence of an obesity-related deleterious microbiota profile that is positively modified by physical activity intervention. Exercise training could be considered an efficient nonpharmacological therapy, reducing inflammatory signaling pathways induced by obesity in children via microbiota modulation.",2020,Exercise reduced plasma glucose levels and increased dynamic strength in the upper and lower extremities compared with the obese control group.,"['children via microbiota modulation', 'obese children', 'obese pediatric patients', 'Thirty-nine obese children']","['control or training group', 'Exercise training', 'strength and endurance combined training program', 'Physical exercise']","['plasma glucose levels', 'gut microbiota and inflammation', 'Bacterial composition and functionality', 'activation of the obesity-associated NLRP3 signaling pathway', 'Anthropometric and biochemical parameters, muscular strength, and inflammatory signaling pathways in mononuclear cells', 'Proteobacteria phylum and Gammaproteobacteria class', 'dynamic strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0751988', 'cui_str': 'Gammaproteobacteria'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",39.0,0.0202337,Exercise reduced plasma glucose levels and increased dynamic strength in the upper and lower extremities compared with the obese control group.,"[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Quiroga', 'Affiliation': 'Complejo Asistencial Universitario (CAULE), León, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Nistal', 'Affiliation': 'Complejo Asistencial Universitario (CAULE), León, Spain.'}, {'ForeName': 'Brisamar', 'Initials': 'B', 'LastName': 'Estébanez', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Porras', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Juárez-Fernández', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Martínez-Flórez', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'García-Mediavilla', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'González-Gallego', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sánchez-Campos', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain. ssanc@unileon.es.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Cuevas', 'Affiliation': 'Institute of Biomedicine (IBIOMED), León, Spain.'}]",Experimental & molecular medicine,['10.1038/s12276-020-0459-0']
1870,32624569,Dopamine manipulations modulate paranoid social inferences in healthy people.,"Altered dopamine transmission is thought to influence the formation of persecutory delusions. However, despite extensive evidence from clinical studies there is little experimental evidence on how modulating the dopamine system changes social attributions related to paranoia, and the salience of beliefs more generally. Twenty seven healthy male participants received 150mg L-DOPA, 3 mg haloperidol, or placebo in a double-blind, randomised, placebo-controlled study, over three within-subject sessions. Participants completed a multi-round Dictator Game modified to measure social attributions, and a measure of belief salience spanning themes of politics, religion, science, morality, and the paranormal. We preregistered predictions that altering dopamine function would affect (i) attributions of harmful intent and (ii) salience of paranormal beliefs. As predicted, haloperidol reduced attributions of harmful intent across all conditions compared to placebo. L-DOPA reduced attributions of harmful intent in fair conditions compared to placebo. Unexpectedly, haloperidol increased attributions of self-interest about opponents' decisions. There was no change in belief salience within any theme. These results could not be explained by scepticism or subjective mood. Our findings demonstrate the selective involvement of dopamine in social inferences related to paranoia in healthy individuals.",2020,L-DOPA reduced attributions of harmful intent in fair conditions compared to placebo.,"['Twenty seven healthy male participants received', 'healthy people', 'healthy individuals']","['Dopamine manipulations', '150mg L-DOPA, 3\u2009mg haloperidol, or placebo', 'haloperidol', 'placebo']","['paranoid social inferences', 'affect (i) attributions of harmful intent and (ii) salience of paranormal beliefs', 'belief salience']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",27.0,0.0895036,L-DOPA reduced attributions of harmful intent in fair conditions compared to placebo.,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Barnby', 'Affiliation': ""Social and Cultural Neuroscience Research Group, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK. joe.barnby@kcl.ac.uk.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': ""Social and Cultural Neuroscience Research Group, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Deeley', 'Affiliation': ""Social and Cultural Neuroscience Research Group, Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Social and Cultural Neuroscience Research Group, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}]",Translational psychiatry,['10.1038/s41398-020-00912-4']
1871,32624575,Vitamin D supplementation: a potential therapeutic agent for metastatic colorectal cancer.,"Preclinical and epidemiological evidence suggests that vitamin D may have anti-cancer activities in patients with colorectal cancer. A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.",2020,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","['patients with colorectal cancer', 'metastatic colorectal cancer', 'patients with metastatic colorectal cancer']","['vitamin D 3  supplementation', 'vitamin D', 'Vitamin D supplementation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],3.0,0.117711,"A recently completed, randomised Phase 2 trial of vitamin D 3  supplementation in patients with metastatic colorectal cancer has shown promising results, and a Phase 3 trial is currently underway.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. kimme_ng@dfci.harvard.edu.'}]",British journal of cancer,['10.1038/s41416-020-0958-8']
1872,32624702,The efficacy of addition of Tenofovir Disoproxil Fumarate to Peg-IFNα-2b is superior to the addition of Entecavir in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone.,"Background:  There are limited data regarding the efficacy of addition of entecavir (ETV) or tenofovir disoproxil fumarate (TDF) to Peg-IFNα-2b in HBeAg positive chronic hepatitis B (CHB) patients without early response to Peg-IFNα-2b. In this study, we aimed to evaluate the efficacy of ETV and TDF in HBeAg positive CHB patients who had a poor response to Peg-INFα-2b at the end of 12 weeks of monotherapy.  Methods:  A total of 40 HBeAg-positive CHB patients who were naive to antiviral therapy were recruited. The patients received a subcutaneous injection of Peg-IFNα-2b (180 µg) once a week for 12 weeks. However, the patients had a poor response to Peg-INFα-2b at the end of the 12-week-period monotherapy. The patients were then divided into two therapeutic protocol groups: (1) Group A: Patients received Peg-IFNα-2b (180 µg) subcutaneously weekly and ETV (0.5 mg) orally once daily for 48 weeks; (2) Group B: Patients received Peg-IFNα-2b (180 µg) subcutaneously weekly and TDF (300 mg) orally once daily for 48 weeks. The therapeutic efficacy was evaluated. Blood samples were collected at baseline and every 12 weeks. Routine biochemical tests including ALT, AST, etc. were measured by automated biochemical technique. HBV DNA was quantified using the TaqMan PCR assay. The levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were measured using a commercial chemiluminescent microparticle immunoassay.  Results:  The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks. At week 48, the mean ΔHBsAg level in Peg-IFNα-2b+TDF group was significantly higher than that in Peg-IFNα-2b +ETV group (-1.799 ± 0.3063 vs. -1.078 ± 0.2028,  P =0.0491). The HBeAg loss rate was significantly higher in TDF add-on group than that in ETV add-on group at week 48 (40% vs. 10%,  P =0.028). At week 48, the proportions of patients with undetectable HBV DNA (<500 IU/mL) were 80% (16 out of 20) and 95% (19 out of 20) in Peg-IFNα-2b+ETV group and Peg-IFNα-2b+TDF group, respectively.  Conclusions:  This real world study demonstrated that the efficacy of addition of TDF to Peg-IFNα-2b is superior to the efficacy of addition of ETV to Peg-IFNα-2b in HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone. However, this present study also requires a larger sample size study to verify in the future.",2020,The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks.,"['HBeAg positive CHB patients with a poor response after 12 weeks of Peg-IFNα-2b treatment alone', 'HBeAg positive CHB patients who had a poor response to Peg-INFα-2b at the end of 12 weeks of monotherapy', '40 HBeAg-positive CHB patients who were naive to antiviral therapy were recruited']","['TDF', 'entecavir (ETV) or tenofovir disoproxil fumarate (TDF', 'Tenofovir Disoproxil Fumarate', 'subcutaneous injection of Peg-IFNα-2b', 'Peg-IFNα-2b (180 µg) subcutaneously weekly and ETV', 'ETV and TDF', 'Peg-IFNα-2b (180 µg) subcutaneously weekly and TDF']","['HBsAg level', 'levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb', 'HBeAg loss rate', 'Blood samples', 'mean ΔHBsAg level', 'therapeutic efficacy']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0312634', 'cui_str': 'Antibody to hepatitis Be antigen'}, {'cui': 'C0312631', 'cui_str': 'Antibody to hepatitis B core antigen'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0481784,The HBsAg level declined rapidly in both two treatment groups during the first 12 weeks and declined gradually in the next 36 weeks.,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Wennan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Tianbin', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Ningdai', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xun', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Qishui', 'Initials': 'Q', 'LastName': 'Ou', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Laboratory Medicine, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Huanhuan', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Fujian Medical University, Fujian, China.'}]",International journal of medical sciences,['10.7150/ijms.45658']
1873,32625091,Investigation of Invigorating  Qi  and Activating Blood Circulation Prescriptions in Treating  Qi  Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial.,"Ischemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM,  Qi -deficiency along with blood-stasis (QDBS) syndrome is one of the common types of IS that is treated by invigorating  Qi  and activating blood circulation. In TCM theory, improving the corresponding degree of prescription-syndrome correlation (PSC) is helpful to improve clinical efficacy. In this study, we intend to use similar prescriptions that invigorate  Qi  and activate blood circulation:  Buyang Huanwu  granules (BHG),  Naoxintong  capsules (NXTC), and  Yangyin Tongnao  granules (YTG). The goal is to evaluate their level of PSC inpatients with IS with QDBS syndrome and find relevant biomarkers to provide an objective basis for precise treatment of TCM and improve the clinical therapeutic effects. A multicenter, randomized, double-blinded, and placebo-controlled intervention trial will be conducted in IS patients with QDBS syndrome, followed by an add-on of Chinese patent medicine. A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio. All subjects will undergo 28 days of treatment and then followed for another 180 days. The primary outcome is the changes in the National Institutes of Health Stroke Scale score after 28 days of medication. The secondary outcomes include the modified Rankin scale score, activity of daily living scale score, and TCM symptom score. Data will be analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2017-Y-004-02). Written informed consent of patients will be required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR1800015189), and the results will be disseminated to the public through peer-reviewed journals and academic conferences.",2020,"A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio.","['IS patients with QDBS syndrome, followed by an add-on of Chinese patent medicine', '160 subjects', 'PSC inpatients with IS with QDBS syndrome', 'Ischemic Stroke Patients']","['BHG, NXTC, YTG, and placebo', 'Invigorating  Qi  and Activating Blood Circulation Prescriptions', 'invigorate  Qi  and activate blood circulation:  Buyang Huanwu  granules (BHG),  Naoxintong  capsules (NXTC), and  Yangyin Tongnao  granules (YTG', 'Traditional Chinese medicine (TCM) and western medicine', 'placebo']","['changes in the National Institutes of Health Stroke Scale score', 'modified Rankin scale score, activity of daily living scale score, and TCM symptom score']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C1137699', 'cui_str': 'buyang huanwu'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C3491556', 'cui_str': 'naoxintong'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3472498', 'cui_str': 'National Institutes of Health stroke scale score'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",160.0,0.208321,"A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Yuan-Jiang', 'Initials': 'YJ', 'LastName': 'Pan', 'Affiliation': 'Department of Chemistry, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiac-Cerebral Diseases, Yinchuan Cardiac-Cerebral Treatment Internet Hospital, Yinchuan, China.'}, {'ForeName': 'Shu-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiovascular Diseases, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Dou', 'Affiliation': 'Department of Cardiovascular Diseases, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Hou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Zhou', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Jie-Hong', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Basic Medical and Public Health College, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Hai-Tong', 'Initials': 'HT', 'LastName': 'Wan', 'Affiliation': 'Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.00892']
1874,32625123,Employers With Metabolic Syndrome and Increased Depression/Anxiety Severity Profit Most From Structured Exercise Intervention for Work Ability and Quality of Life.,"Background


Major depressive disorder and anxiety disorders are associated with less productivity, earlier retirement, and more sick-days at the workplace. These associations also exist for patients with metabolic syndrome. For both, exercise is a generally recommended part of multimodal treatments. However, for individuals with metabolic syndrome, in which depression and anxiety is more prevalent and severe, evidence for the efficacy of exercise interventions is limited.
Methods


Company employees with diagnosed metabolic syndrome (n=314, age: 48 ± 8 yrs) were randomized to a 6-month exercise intervention (150 min per week) or wait-list control. Participants received individual recommendations for exercise activities by personal meetings, telephone, or  via  a smartphone app. Physical activities were supervised and adapted using activity monitor data transferred to a central database. Work ability (work ability index), depression severity and anxiety severity [hospital anxiety and depression scale (HADS)], and health-related quality of live [short form 36 (SF-36)] were assessed.
Results


We included 314 subjects from which 287 finished the intervention. Total work ability, depression- and anxiety severity, and the mental component score of the SF-36 improved after 6 months exercise compared to controls. After baseline stratification for normal (HADS scores 0-7) and increased depression- and anxiety scores (HADS scores 8-21) individuals with increased severity scores had similar age, body composition, blood lipids, and cardiorespiratory fitness compared to those with normal scores, but lower total work ability and component sum scores of health-related quality of life. After 6 months total work ability increased in the exercise group compared to controls with the magnitude of the observed increase being significantly greater for subjects with increased depression- and anxiety severity at baseline compared to those with normal severity scores.
Conclusions


A 6-month exercise intervention for company employees with metabolic syndrome showed strongest effects on self-perceived work ability in individuals with mild to severe depression- and anxiety severity. This suggests exercise programs offered to workers with metabolic syndrome not only reduces individual disease risk but may also reduce healthcare and employers costs arising from metabolic syndrome and mental disease conditions.
Clinical Trial Registration


ClinicalTrials.gov, identifier NCT03293264.",2020,"After 6 months total work ability increased in the exercise group compared to controls with the magnitude of the observed increase being significantly greater for subjects with increased depression- and anxiety severity at baseline compared to those with normal severity scores.
","['Methods\n\n\nCompany employees with diagnosed metabolic syndrome (n=314, age: 48 ± 8 yrs', 'workers with metabolic syndrome', 'company employees with metabolic syndrome', 'individuals with mild to severe depression- and anxiety severity', '314 subjects from which 287 finished the intervention', 'individuals with metabolic syndrome', 'patients with metabolic syndrome']","['Structured Exercise Intervention', '6-month exercise intervention (150 min per week) or wait-list control', 'exercise intervention', 'individual recommendations for exercise activities by personal meetings, telephone, or  via  a smartphone app']","['total work ability', 'Depression/Anxiety Severity Profit', 'Work ability (work ability index), depression severity and anxiety severity [hospital anxiety and depression scale (HADS)], and health-related quality of live [short form 36 (SF-36', 'Total work ability, depression- and anxiety severity, and the mental component score of the SF-36', 'Work Ability and Quality of Life', 'depression- and anxiety scores (HADS scores', 'total work ability and component sum scores of health-related quality of life', 'depression- and anxiety severity', 'body composition, blood lipids, and cardiorespiratory fitness']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",314.0,0.0436874,"After 6 months total work ability increased in the exercise group compared to controls with the magnitude of the observed increase being significantly greater for subjects with increased depression- and anxiety severity at baseline compared to those with normal severity scores.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kai G', 'Initials': 'KG', 'LastName': 'Kahl', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Bayerle', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rolff', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thorben', 'Initials': 'T', 'LastName': 'Sundermeier', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Eigendorf', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Katriona', 'Initials': 'K', 'LastName': 'Keller-Varady', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ensslen', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nachbar', 'Affiliation': 'Volkswagen AG, Wolfsburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lauenstein', 'Affiliation': 'Audi BKK Health Insurance, Ingolstadt, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Böthig', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Terkamp', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00562']
1875,32625129,"Individuals vs. BARD: Experimental Evaluation of an Online System for Structured, Collaborative Bayesian Reasoning.","US intelligence analysts must weigh up relevant evidence to assess the probability of their conclusions, and express this reasoning clearly in written reports for decision-makers. Typically, they work alone with no special analytic tools, and sometimes succumb to common probabilistic and causal reasoning errors. So, the US government funded a major research program (CREATE) for four large academic teams to develop new structured, collaborative, software-based methods that might achieve better results. Our team's method (BARD) is the first to combine two key techniques: constructing causal Bayesian network models (BNs) to represent analyst knowledge, and small-group collaboration via the Delphi technique. BARD also incorporates compressed, high-quality online training allowing novices to use it, and checklist-inspired report templates with a rudimentary AI tool for generating text explanations from analysts' BNs. In two prior experiments, our team showed BARD's BN-building assists probabilistic reasoning when used by individuals, with a large effect (Glass' Δ 0.8) (Cruz et al., 2020), and even minimal Delphi-style interactions improve the BN structures individuals produce, with medium to very large effects (Glass' Δ 0.5-1.3) (Bolger et al., 2020). This experiment is the critical test of BARD as an integrated system and possible alternative to business-as-usual for intelligence analysis. Participants were asked to solve three probabilistic reasoning problems spread over 5 weeks, developed by our team to test both quantitative accuracy and susceptibility to tempting qualitative fallacies. Our 256 participants were randomly assigned to form 25 teams of 6-9 using BARD and 58 individuals using Google Suite and (if desired) the best pen-and-paper techniques. For each problem, BARD outperformed this control with very large to huge effects (Glass' Δ 1.4-2.2), greatly exceeding CREATE's initial target. We conclude that, for suitable problems, BARD already offers significant advantages over both business-as-usual and existing BN software. Our effect sizes also suggest BARD's BN-building and collaboration combined beneficially and cumulatively, although implementation differences decreased performances compared to Cruz et al. (2020), so interaction may have contributed. BARD has enormous potential for further development and testing of specific components and on more complex problems, and many potential applications beyond intelligence analysis.",2020,"BARD has enormous potential for further development and testing of specific components and on more complex problems, and many potential applications beyond intelligence analysis.",['256 participants'],[],[],[],[],[],256.0,0.028086,"BARD has enormous potential for further development and testing of specific components and on more complex problems, and many potential applications beyond intelligence analysis.","[{'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Korb', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Nyberg', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Oshni Alvandi', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Shreshth', 'Initials': 'S', 'LastName': 'Thakur', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ozmen', 'Affiliation': 'Department of Economics, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Pearson', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Nicholson', 'Affiliation': 'Faculty of Information Technology, Monash University, Melbourne, VIC, Australia.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01054']
1876,32625143,Skill Acquisition Methods Fostering Physical Literacy in Early-Physical Education (SAMPLE-PE): Rationale and Study Protocol for a Cluster Randomized Controlled Trial in 5-6-Year-Old Children From Deprived Areas of North West England.,"Background


There is a need for interdisciplinary research to better understand how pedagogical approaches in primary physical education (PE) can support the linked development of physical, cognitive and affective aspects of physical literacy and physical activity behaviors in young children living in deprived areas. The  Skill Acquisition Methods fostering Physical Literacy in Early-Physical Education (SAMPLE-PE)  study aims to examine the efficacy of two different pedagogies for PE, underpinned by theories of motor learning, to foster physical literacy.
Methods


SAMPLE-PE will be evaluated through a cluster-randomized controlled trial targeting 5-6 year old children from schools located in areas of high deprivation in Merseyside, North-West England. Schools will be randomly allocated to one of three conditions:  Linear Pedagogy ,  Non-linear Pedagogy , or Control. Non-linear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice. Data will be collected at baseline (T0), immediately post-intervention (T1), and 6 months after the intervention has finished (T2). Children's movement competence is the primary outcome in this trial. Secondary outcomes include physical activity, perceived competence, motivation, executive functions, and self-regulation. An extensive process evaluation will also examine implementation factors such as intervention context, reach, dose, fidelity and acceptability.
Discussion


The SAMPLE-PE project will enable better understanding surrounding how to operationalise physical literacy through enrichment of PE practices in early PE. The study will provide robust scientific evidence regarding the efficacy of underpinning PE pedagogy with theories of motor learning to promote the development of physical literacy.
Trial Registration


Retrospectively registered on 5th September 2018 at ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (Identifier: NCT03551366).",2020,"Schools will be randomly allocated to one of three conditions:  Linear Pedagogy ,  Non-linear Pedagogy , or Control. Non-linear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice.","['5-6-Year-Old Children From Deprived Areas of North West England', '5-6 year old children from schools located in areas of high deprivation in Merseyside, North-West England', 'young children living in deprived areas']","['Skill Acquisition Methods Fostering Physical Literacy', 'Linear Pedagogy ,  Non-linear Pedagogy , or Control. Non-linear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches']","['physical activity, perceived competence, motivation, executive functions, and self-regulation']","[{'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0454865', 'cui_str': 'Merseyside'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1510624', 'cui_str': 'Pedagogy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.185058,"Schools will be randomly allocated to one of three conditions:  Linear Pedagogy ,  Non-linear Pedagogy , or Control. Non-linear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rudd', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Crotti', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Fitton-Davies', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""O'Callaghan"", 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Bardid', 'Affiliation': 'School of Education, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Utesch', 'Affiliation': 'Institute for Sport and Exercise Sciences, University of Münster, Münster, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Boddy', 'Affiliation': 'Physical Activity Exchange, Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Colum J', 'Initials': 'CJ', 'LastName': 'Cronin', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Knowles', 'Affiliation': 'Physical Activity Exchange, Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulkes', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Watson', 'Affiliation': 'Physical Activity Exchange, Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Rome, Italy.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Button', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'David Revalds', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Buszard', 'Affiliation': 'Institute for Health and Sport, Footscray Park Campus, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Walsh', 'Affiliation': 'School of Sport Leisure and Nutrition, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Foweather', 'Affiliation': 'Physical Activity Exchange, Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01228']
1877,32625161,Single-Center 8-Years Clinical Follow-Up of Cladribine-Treated Patients From Phase 2 and 3 Trials.,"Background:  Cladribine is approved for the treatment of highly-active relapsing multiple sclerosis (MS), where it is also effective on disability progression. In the present single-center study, we aim to report on the 8-years clinical follow-up of 27 patients included in phase 2 and 3 clinical trials for cladribine.  Methods:  We included patients exposed to cladribine ( n  = 13) or placebo ( n  = 14) in ONWARD, CLARITY, and ORACLE-MS trials, and followed-up at the same center after trial termination. Outcomes of long-term disease progression were recorded.  Results:  During 8-year follow-up, patients treated with cladribine presented with reduced risk of EDSS progression (HR = 0.148; 95%CI = 0.031, 0.709;  p  = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872;  p  = 0.036), and of SP conversion (HR = 0.010; 95%CI = 0.001, 0.329;  p  = 0.010), when compared with placebo.  Conclusions:  Our exploratory study provides additional evidence that cladribine may be useful to prevent or, at least, mitigate the risk of disability progression after 8 years.",2020,"During 8-year follow-up, patients treated with cladribine presented with reduced risk of EDSS progression (HR = 0.148; 95%CI = 0.031, 0.709;  p  = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872;  ","['27 patients included in phase 2 and 3 clinical trials for cladribine', ' n  = 13) or']","['cladribine', 'Cladribine', 'placebo']","['reduced risk of EDSS progression', 'SP conversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",27.0,0.186886,"During 8-year follow-up, patients treated with cladribine presented with reduced risk of EDSS progression (HR = 0.148; 95%CI = 0.031, 0.709;  p  = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872;  ","[{'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Moccia', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lanzillo', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Petruzzo', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Nozzolillo', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'De Angelis', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carotenuto', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Palladino', 'Affiliation': 'Department of Primary Care and Public Health, Imperial College, London, United Kingdom.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Brescia Morra', 'Affiliation': 'Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Clinical Care and Research Center, Federico II University, Naples, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.00489']
1878,32625162,Dynamic Stability and Trunk Control Improvements Following Robotic Balance and Core Stability Training in Chronic Stroke Survivors: A Pilot Study.,"Stroke survivors show greater postural oscillations and altered muscular activation compared to healthy controls. This results in difficulties in walking and standing, and in an increased risk of falls. A proper control of the trunk is related to a stable walk and to a lower falling risk; to this extent, rehabilitative protocols are currently working on core stability. The main objective of this work was to evaluate the effectiveness of trunk and balance training performed with a new robotic device designed for evaluation and training of balance and core stability, in improving the recovery of chronic stroke patients compared with a traditional physical therapy program. Thirty chronic stroke patients, randomly divided in two groups, either underwent a traditional rehabilitative protocol, or a robot-based program. Each patient was assessed before and after the rehabilitation and at 3-months follow-up with clinical and robot-based evaluation exercises focused on static and dynamic balance and trunk control. Results from clinical scores showed an improvement in both groups in balance and trunk control. Robot-based indices analysis indicated that the experimental group showed greater improvements in proprioceptive control, reactive balance and postural control in unstable conditions, compared to the control group, showing an improved trunk control with reduced compensatory strategies at the end of the training. Moreover, the experimental group had an increased retention of the benefits obtained with training at 3 months follow up. These results support the idea that such robotic device is a promising tool for stroke rehabilitation.",2020,"Robot-based indices analysis indicated that the experimental group showed greater improvements in proprioceptive control, reactive balance and postural control in unstable conditions, compared to the control group, showing an improved trunk control with reduced compensatory strategies at the end of the training.","['Thirty chronic stroke patients', 'chronic stroke patients', 'Chronic Stroke Survivors']","['traditional rehabilitative protocol, or a robot-based program', 'Robotic Balance and Core Stability Training', 'traditional physical therapy program']","['postural oscillations and altered muscular activation', 'proprioceptive control, reactive balance and postural control']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",30.0,0.0153808,"Robot-based indices analysis indicated that the experimental group showed greater improvements in proprioceptive control, reactive balance and postural control in unstable conditions, compared to the control group, showing an improved trunk control with reduced compensatory strategies at the end of the training.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'De Luca', 'Affiliation': 'Movendo Technology, Genoa, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Squeri', 'Affiliation': 'Movendo Technology, Genoa, Italy.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Barone', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Honorè', 'Initials': 'H', 'LastName': 'Vernetti Mansin', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Department of Informatics, Bioengineering, Robotics, and System Engineering, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Ivano', 'Initials': 'I', 'LastName': 'Pisu', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Cassiano', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Capra', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Lentino', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'De Michieli', 'Affiliation': 'Rehab Technologies, IIT, Genoa, Italy.'}, {'ForeName': 'Carlo A', 'Initials': 'CA', 'LastName': 'Sanfilippo', 'Affiliation': 'Movendo Technology, Genoa, Italy.'}, {'ForeName': 'Jody A', 'Initials': 'JA', 'LastName': 'Saglia', 'Affiliation': 'Movendo Technology, Genoa, Italy.'}, {'ForeName': 'Giovanni A', 'Initials': 'GA', 'LastName': 'Checchia', 'Affiliation': 'Recovery and Functional Reeducation Unit, Santa Corona Hospital, ASL2 Savonese, Pietra Ligure, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.00494']
1879,32626450,Paving the way to better population health through personalised nutrition.,"As each individual person differs from the next in multiple ways, it is a beguiling idea that our individual nutritional needs also differ. In support of this idea, findings from nutritional intervention studies provide ample evidence of considerable interindividual variation in response to the same dietary exposure. We have a limited understanding of the mechanisms responsible for this variation but, following sequencing of the human genome, the role of genes in explaining interindividual differences has been centre stage. In addition, evidence of diet-gene interactions that influence phenotype, including health, emphasises the importance of both nature and nurture. Eating patterns are major determinants of health, so public health advice to reduce the risk of common complex diseases focuses on diet. However, most dietary interventions are relatively ineffective and personalised approaches that tailor the intervention to the individual may be more acceptable and more effective. That idea was tested in the Food4Me study in which adults from seven European countries were randomised to one of four treatment groups in an internet-delivered dietary intervention. Compared with the Control (standardised healthy eating advice), those people randomised to a personalised nutrition intervention had bigger, sustained changes, in eating behaviour after 6 months. However, including more complex phenotypic and/or genotypic information in developing the personalised nutrition advice had no added benefit. Research in personalised nutrition is broadening its scope to consider effects mediated by the gut microbiome as well as multiple aspects of genotype and phenotype. Such research has the potential to explain interindividual differences in the response to specific dietary factors and may provide a scientific basis for more refined approaches to personalised nutrition. However, if this research is to make a significant contribution to improving public health, it will need to address the psychological, social, economic and cultural factors that influence eating patterns to ensure that advice is converted into action and that improved dietary habits are sustained in perpetuity.",2019,"Compared with the Control (standardised healthy eating advice), those people randomised to a personalised nutrition intervention had bigger, sustained changes, in eating behaviour after 6 months.",['adults from seven European countries'],"['personalised nutrition intervention', 'internet-delivered dietary intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",[],,0.0252228,"Compared with the Control (standardised healthy eating advice), those people randomised to a personalised nutrition intervention had bigger, sustained changes, in eating behaviour after 6 months.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre Institute of Cellular Medicine and Newcastle University Institute for Ageing Newcastle University Newcastle on Tyne NE2 4HH UK.'}]",EFSA journal. European Food Safety Authority,['10.2903/j.efsa.2019.e170713']
1880,32626548,The impact of oral nicorandil pre-treatment on ST resolution and clinical outcome of patients with acute ST-segment elevation myocardial infarction undergoing primary coronary angioplasty: A randomized placebo controlled trial.,"Introduction:  Literature has shown the effects of intravenous/intracoronary nicorandil on increased myocardial salvage in patients with ST-segment elevation myocardial infarction (STEMI) treated with mechanical reperfusion. However, the possible cardioprotective effect of oral nicorandil on the clinical outcome prior to primary coronary angioplasty is not well documented. Our aim was to assess the effect of oral nicorandil on primary percutaneous coronary intervention (PPCI).  Methods:  A total of 240 patients with acute STEMI undergoing PPCI were randomly assigned to oral nicorandil (Intervention, n=116) and placebo (Control, n=124) groups. The intervention group received 20 mg oral nicorandil at the emergency department and another 20 mg oral nicorandil in the catheterization laboratory just before the procedure. The control group received matched placebo. Our primary outcome was ST-segment resolution ≥50% one hour after primary angioplasty. Secondary outcome was in-hospital major adverse cardiovascular events (MACE), defined as a composite of death, ventricular arrhythmia, heart failure and stroke.  Results:  In the patients of intervention and control groups, the occurrence of ST-segment resolution ≥ 50% were 68.1% and 62.9% respectively, ( P  =0.27). In-hospital MACE occurred less frequently in the intervention group, compared to placebo group (11.2% vs. 22.5%,  P  =0.012).  Conclusion:  Although the administration of oral nicorandil before primary coronary angioplasty did not improve ST-segment resolution in patients with acute STEMI, its promoting effects was remarkable on in-hospital clinical outcomes.  Clinical Registration:  IRCT20140512017666N1.",2020,"In-hospital MACE occurred less frequently in the intervention group, compared to placebo group (11.2% vs. 22.5%,  P  =0.012).  ","['patients with ST-segment elevation myocardial infarction (STEMI) treated with mechanical reperfusion', '240 patients with acute STEMI undergoing PPCI', 'patients with acute ST-segment elevation myocardial infarction undergoing primary coronary angioplasty']","['nicorandil', 'intracoronary nicorandil', 'nicorandil pre-treatment', '20 mg oral nicorandil at the emergency department and another 20 mg oral nicorandil', 'oral nicorandil', 'placebo']","['myocardial salvage', 'occurrence of ST-segment resolution ≥', 'hospital major adverse cardiovascular events (MACE), defined as a composite of death, ventricular arrhythmia, heart failure and stroke', 'ST-segment resolution', 'ST resolution and clinical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}]","[{'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",240.0,0.0916191,"In-hospital MACE occurred less frequently in the intervention group, compared to placebo group (11.2% vs. 22.5%,  P  =0.012).  ","[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Akbari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Aslanabadi', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Sohrabi', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Pourafkari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Akbarzadeh', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Javadzadegan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Separham', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Sehati', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cardiovascular and thoracic research,['10.34172/jcvtr.2020.16']
1881,32626563,A Comparison between 10-day and 12-day Concomitant Regimens for  Helicobacter Pylori  Eradication: A Randomized Clinical Trial.,"BACKGROUND  Helicobacter pylori (H. pylori)  infection is one of the most common bacterial infections worldwide, which is associated with peptic ulcer disease and gastric cancer. In this study, we compared the efficacy of 10-day versus 12-day concomitant therapy as the first-line treatment for  H. pylori  eradication in Iran. METHODS 218 patients with peptic ulcer disease and naïve  H. pylori  infection, were randomly divided into two groups to receive either 10-day or 12-day concomitant regimens, composed of pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily. Eight weeks after treatment, H. pylori eradication was assessed by 14C- urea breath test. The trial was registered in the Iranian Registry of Clinical Trials (code: IRCT20170521034070N2). RESULTS 212 patients completed the study. According to the intention to treat analysis, the eradication rates were 83.6% (95% CI: 76.6-90.5) and 88.8% (95% CI: 82.8-94.7) in 10-day and 12-day concomitant therapy groups, respectively ( p  = 0.24). Per-protocol eradication rates were 85.9% (95% CI: 79.3-92.4) and 92.6% (95% CI: 87.6-97.5), respectively ( p  = 0.19). The rates of severe side effects were not statistically different between the two groups (3.6% vs. 8.1%;  p  = 0.428). CONCLUSION 12-day concomitant therapy could achieve ideal eradication rates by both intention to treat and perprotocol analyses. In order to reduce the cost of drugs and the rate of adverse effects of therapy, among 10-day and 12day regimens, 12-day concomitant therapy seems to be a good alternative to 14-day concomitant therapy that has been suggested by international guidelines.",2020,"Per-protocol eradication rates were 85.9% (95% CI: 79.3-92.4) and 92.6% (95% CI: 87.6-97.5), respectively ( p  = 0.19).","['Helicobacter Pylori  Eradication', '212 patients completed the study', '218 patients with peptic ulcer disease and naïve  H. pylori  infection', 'H. pylori  eradication in Iran']","['pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole']","['ideal eradication rates', 'rates of severe side effects', 'pylori eradication', 'eradication rates', 'Per-protocol eradication rates', '14C- urea breath test']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C1126048', 'cui_str': 'pantoprazole 40 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0795589', 'cui_str': 'Urea [14C]'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]",218.0,0.0598148,"Per-protocol eradication rates were 85.9% (95% CI: 79.3-92.4) and 92.6% (95% CI: 87.6-97.5), respectively ( p  = 0.19).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Bari', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Tarang', 'Initials': 'T', 'LastName': 'Taghvaei', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Yaghoobi', 'Affiliation': 'Associate Professor of Gastroenterology, Division of Gastroenterology, Deartment of Medicine, McMaster University Medical Center, Hamiton, Ontarion, Canada.'}]",Middle East journal of digestive diseases,['10.34172/mejdd.2020.169']
1882,32626617,Intrathecal Use of Isobaric Levobupivacaine 0.5% Versus Isobaric Ropivacaine 0.75% for Lower Abdominal and Lower Limb Surgeries.,"Background This study was undertaken to compare and evaluate the efficacy of 3-ml 0.5% isobaric levobupivacaine versus 3-ml 0.75% isobaric ropivacaine in patients undergoing elective lower abdominal and lower limb surgeries. Methods We allocated 60 patients into two groups (n=30 each) to receive either a spinal block of 3-ml 0.5% isobaric levobupivacaine (group L) or 3-ml 0.75% isobaric ropivacaine (group R). Haemodynamic parameters were measured intraoperatively till the end of surgery and postoperatively for two hours. The onset and duration of sensory block and motor block were recorded. Adverse events were also recorded. The student's unpaired t-test was used for comparing the continuous variables. Results The mean age in group L was 37.83 ±16.51 years and the mean age in group R was 38.50 ±12.97 years. The mean onset of sensory block in group L (6.97 ±1.82 mins) was significantly faster than in group R (8.47 ±2.55 mins), p<0.05. Similarly, so was the mean onset of motor block in group L (10.27 ±1.92 mins) versus group R (12.93 ±2.55 mins), p<0.05. The mean duration of sensory block in group L (147.63 ±27.53 mins) was significantly longer than in group R (97.40 ±12.38 mins), p<0.05, as was the mean duration of motor block in group L (207.33 ±22.27 mins) versus group R (146.60 ±21.22 mins), p<0.05. In group L, 13.3% of patients had complications, with hypotension being the most common (6.7%); in group R, 40% had complications, of which bradycardia was the most common (13.3%). Conclusion There was an earlier onset of sensory and motor block and prolonged duration of sensory and motor block with intrathecal administration of 3-ml 0.5% isobaric levobupivacaine as compared to 3-ml 0.75% isobaric ropivacaine. Haemodynamic parameters were more stable with levobupivacaine than ropivacaine. Adverse effects were more common with ropivacaine.",2020,There was an earlier onset of sensory and motor block and prolonged duration of sensory and motor block with intrathecal administration of 3-ml 0.5% isobaric levobupivacaine as compared to 3-ml 0.75% isobaric ropivacaine.,"['patients undergoing elective lower abdominal and lower limb surgeries', '60 patients into two groups (n=30 each) to receive either a']","['3-ml 0.5% isobaric levobupivacaine versus 3-ml\xa00.75% isobaric ropivacaine', 'Isobaric Levobupivacaine', 'ropivacaine', 'levobupivacaine', 'isobaric ropivacaine', 'spinal block of 3-ml 0.5%\xa0isobaric levobupivacaine (group L) or 3-ml 0.75% isobaric ropivacaine', 'isobaric levobupivacaine', 'Isobaric Ropivacaine']","['onset and duration of sensory block\xa0and\xa0motor block', 'Adverse events', 'mean duration of motor\xa0block', 'mean duration of sensory block', 'sensory and motor block and prolonged duration of sensory and motor block', 'Adverse effects', 'Haemodynamic parameters', 'mean onset of sensory block', 'mean onset of motor block']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0441846', 'cui_str': 'Group L'}]","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",60.0,0.0687838,There was an earlier onset of sensory and motor block and prolonged duration of sensory and motor block with intrathecal administration of 3-ml 0.5% isobaric levobupivacaine as compared to 3-ml 0.75% isobaric ropivacaine.,"[{'ForeName': 'Priyank', 'Initials': 'P', 'LastName': 'Samar', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}, {'ForeName': 'Sarla', 'Initials': 'S', 'LastName': 'Pandya', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}, {'ForeName': 'Tanvi A', 'Initials': 'TA', 'LastName': 'Dhawale', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}]",Cureus,['10.7759/cureus.8373']
1883,32626668,Is Telenursing an Effective Method to Control BMI and HbA1c in Illiterate Patients Aged 50 Years and Older With Type 2 Diabetes? A Randomized Controlled Clinical Trial.,"Introduction:  Telenursing is a simple method to provide and maintain nursing care for patients with chronic illness such as diabetes. This study aimed to determine the effectiveness of telenursing on body mass index (BMI) and glycosylated hemoglobin (HbA1c) in illiterate patients aged 50 years and older with type 2 diabetes.  Methods:  A randomized controlled clinical trial was performed. Sixty patients with type 2 diabetes who referred to Aligoodarz diabetes clinic (Lorestan, Iran) were randomly assigned to the intervention and control group. Each patient was assessed before and after intervention for the following clinical parameters: HbA1c by Drew-DS5 analyzer and weight by scale (Sahand BMI electronic scale /Iran). All patients received diabetes self-care training for 3 days before the study. Telephone follow ups were applied in intervention group for 12 weeks. The data were analyzed using chi-square, paired t test and independent t test by SPSS11.  Results:  Results showed statistically significant decrease in BMI at the end of the training from 29.28 (3.29) to 28.35 (3.37) kg/m 2 and statistically significant decrease in HbA1c from 8.96 (1.24) to 7.56 (0.71) in the intervention group. The effect size base on Cohen's formula for BMI and HbA1c was Cohen's d = 2.85, effect size r = 0.81 and Cohen's d = 2.04, effect size r = 0.71, respectively.  Conclusion:  The findings indicate that nurse-led telephone follow up can increase adherence from treatment program and has beneficial effects on HbA1c and BMI in illiterate patients aged 50 years and older with type 2 diabetes.",2020,The findings indicate that nurse-led telephone follow up can increase adherence from treatment program and has beneficial effects on HbA1c and BMI in illiterate patients aged 50 years and older with type 2 diabetes.,"['patients with chronic illness such as diabetes', 'Sixty patients with type 2 diabetes who referred to Aligoodarz diabetes clinic (Lorestan, Iran', 'Illiterate Patients', 'Aged 50 Years and Older With Type 2 Diabetes', 'illiterate patients aged 50 years and older with type 2 diabetes']",['diabetes self-care training'],"['HbA1c by Drew-DS5 analyzer and weight by scale (Sahand BMI electronic scale /Iran', 'body mass index (BMI) and glycosylated hemoglobin (HbA1c', 'BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",60.0,0.0594545,The findings indicate that nurse-led telephone follow up can increase adherence from treatment program and has beneficial effects on HbA1c and BMI in illiterate patients aged 50 years and older with type 2 diabetes.,"[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Shahsavari', 'Affiliation': 'Department of Nursing, School of Nursing, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Bakhshandeh Bavarsad', 'Affiliation': 'Department of Nursing, School of Nursing, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",Journal of caring sciences,['10.34172/JCS.2020.011']
1884,32626673,Effect of Programmed Family Presence in Coronary Care Units on Patients' and Families' Anxiety.,"Introduction:  Hospitalization of patients in the intensive care units always has negative consequences such as anxiety and concern for patients and their families. This study aimed to investigate the effect of programmed family presence in intensive care units on patients' and families' anxiety.  Methods:  This was a quasi-experimental study conducted in Iran. The eligible patients and a member of their families were assigned into two groups (N = 80) through convenience sampling. The family members in the experimental group were allowed to attend twice a day for 15 minutes in a planned way beside the patient and contribute to their clinical primary care. In the control group, the family members had a strict limitation to visit their patients based on the usual policy. Anxiety in both groups at the beginning and on the third day of patient's admission was measured, using Spielberger's questionnaire. The data were analyzed with SPSS version13.  Results:  The mean score of anxiety in the control group did not show significant difference in patients and in families, however it had decreased significantly in the experimental group after the intervention for both patients and families. The results showed that mean differences between the two groups was statistically significant in patients and families.  Conclusion:  The planned presence of the family of patients in coronary care unit (CCU) played a crucial role in reducing the anxiety of patients and their family. Furthermore, it is recommended that strategies of visiting policy in intensive care units (ICUs) should be revised and the possibility be provided for the families' planned presence and participation in the patient care.",2020,"The mean score of anxiety in the control group did not show significant difference in patients and in families, however it had decreased significantly in the experimental group after the intervention for both patients and families.","['Iran', ""patients' and families' anxiety"", ""Coronary Care Units on Patients' and Families' Anxiety""]",['coronary care unit (CCU'],"['Anxiety', 'mean score of anxiety']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}]","[{'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0171989,"The mean score of anxiety in the control group did not show significant difference in patients and in families, however it had decreased significantly in the experimental group after the intervention for both patients and families.","[{'ForeName': 'Seyyedeh Halimeh', 'Initials': 'SH', 'LastName': 'Kamali', 'Affiliation': 'Department of Critical Care Nursing and Management, School of Nursing and Midwifery, Tehran University of Medical Sciences; Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Imanipour', 'Affiliation': 'Department of Critical Care Nursing and Management, Nursing and Midwifery Care Research Center; Tehran University of Medical Sciences; Tehran; Iran.'}, {'ForeName': 'Hormat Sadat', 'Initials': 'HS', 'LastName': 'Emamzadeh Ghasemi', 'Affiliation': 'Department of Critical Care Nursing and Management; School of Nursing and Midwifery, Tehran University of Medical Sciences; Tehran; Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razaghi', 'Affiliation': 'Laser Application in Medical Sciences Research Center; Shahid Beheshti University of Medical Sciences; Tehran; Iran.'}]",Journal of caring sciences,['10.34172/JCS.2020.016']
1885,32626744,Inspiratory Muscle Training in Obstructive Sleep Apnea Associating Diabetic Peripheral Neuropathy: A Randomized Control Study.,"Objective


This work is aimed at assessing the effects of inspiratory muscle training on lung functions, inspiratory muscle strength, and aerobic capacity in diabetic peripheral neuropathy (DPN) patients with obstructive sleep apnea (OSA).
Methods


A randomized control study was performed on 55 patients diagnosed with DPN and OSA. They were assigned to the training group (IMT,  n  = 28) and placebo training group (P-IMT,  n  = 27). Inspiratory muscle strength, lung functions, and aerobic capacity were evaluated before and after 12 weeks postintervention. An electronic inspiratory muscle trainer was conducted, 30 min a session, three times a week for 12 consecutive weeks.
Results


From seventy-four patients, 55 have completed the study program. A significant improvement was observed in inspiratory muscle strength ( p  < 0.05) in the IMT group while no changes were observed in the P-IMT group ( p  > 0.05). No changes were observed in the lung function in the two groups ( p  > 0.05). Also, VO 2 max and VCO 2 max changed significantly after training in the IMT group ( p  < 0.05) while no changes were observed in the P-IMT group ( p  > 0.05). Other cardiopulmonary exercise tests did not show any significant change in both groups ( p  > 0.05).
Conclusions


Based on the outcomes of the study, it was found that inspiratory muscle training improves inspiratory muscle strength and aerobic capacity without a notable effect on lung functions for diabetic patients suffering from DPN and OSA.",2020,A significant improvement was observed in inspiratory muscle strength ( p  < 0.05) in the IMT group while no changes were observed in the P-IMT group ( p  > 0.05).,"['Obstructive Sleep Apnea Associating Diabetic Peripheral Neuropathy', '55 patients diagnosed with DPN and OSA', 'diabetic peripheral neuropathy (DPN) patients with obstructive sleep apnea (OSA', 'diabetic patients suffering from DPN and OSA']","['placebo training', 'Inspiratory Muscle Training', 'electronic inspiratory muscle trainer', 'inspiratory muscle training']","['VO 2 max and VCO 2 max', 'inspiratory muscle strength', 'lung functions', 'inspiratory muscle strength and aerobic capacity', 'Inspiratory muscle strength, lung functions, and aerobic capacity', 'lung function', 'lung functions, inspiratory muscle strength, and aerobic capacity']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",55.0,0.0106849,A significant improvement was observed in inspiratory muscle strength ( p  < 0.05) in the IMT group while no changes were observed in the P-IMT group ( p  > 0.05).,"[{'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",BioMed research international,['10.1155/2020/5036585']
1886,32407288,Telemonitoring Versus Usual Care for Elderly Patients With Heart Failure Discharged From the Hospital in the United States: Cost-Effectiveness Analysis.,"BACKGROUND


Telemonitoring-guided interventional management reduces the need for hospitalization and mortality of patients with chronic heart failure (CHF).
OBJECTIVE


This study aimed to analyze the cost-effectiveness of usual care with and without telemonitoring-guided management in patients with CHF discharged from the hospital, from the perspective of US health care providers.
METHODS


A lifelong Markov model was designed to estimate outcomes of (1) usual care alone for all postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2) usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring for patients with NYHA class II to IV. Model inputs were derived from the literature and public data. Sensitivity analyses were conducted to assess the robustness of model. The primary outcomes were total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
RESULTS


In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs). ICERs of the telemonitoring for NYHA class III to IV group (US $35,393 per QALY) and the telemonitoring for NYHA class II to IV group (US $38,261 per QALY) were lower than the ICER of the universal telemonitoring group (US $100,458 per QALY). One-way sensitivity analysis identified five critical parameters: odds ratio of hospitalization for telemonitoring versus usual care, hazard ratio of all-cause mortality for telemonitoring versus usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class I, and CHF hospitalization cost for NYHA class II. In probabilistic sensitivity analysis, probabilities of the universal telemonitoring, telemonitoring for NYHA class II to IV, telemonitoring for NYHA class III to IV, and universal usual care groups to be accepted as cost-effective at US $50,000 per QALY were 2.76%, 76.31%, 18.6%, and 2.33%, respectively.
CONCLUSIONS


Usual care for all discharged patients with CHF plus telemonitoring-guided management for NYHA class II to IV patients appears to be the preferred cost-effective strategy.",2020,"In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs).","['Elderly Patients With Heart Failure', 'postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2', 'patients with chronic heart failure (CHF', 'patients with CHF discharged from the hospital, from the perspective of US health care providers']","['usual care with and without telemonitoring-guided management', 'usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring', 'Telemonitoring Versus Usual Care']","['usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class', 'cost-effectiveness', 'total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0172675,"In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs).","[{'ForeName': 'Xinchan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}, {'ForeName': 'Joyce Hs', 'Initials': 'JH', 'LastName': 'You', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}]",JMIR mHealth and uHealth,['10.2196/17846']
1887,32632489,"Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial.","BACKGROUND


Transversus abdominis plane (TAP) block is considered a reliable locoregional technique for pain control after laparoscopic colorectal surgery. However, no clear benefit of TAP block over wound infiltration has been demonstrated by the current literature. This multicenter randomized clinical trial tested the non-inferiority of wound infiltration (WI) compared to WI plus laparoscopic-assisted TAP block (L-TAP).
METHODS


All patients with colorectal cancer and diverticular disease scheduled for laparoscopic resection at the Division of General and Hepatobiliary Surgery, University of Verona Hospital Trust, Verona, Italy and at the Colorectal Cancer Center, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea, between April 2018 and March 2019 were considered for the trial. Patients were randomly allocated to either the WI group or the WI plus L-TAP group in a 1:1 allocation ratio. In total, 108 patients entered the study and 102 patients were analyzed; 50 patients received WI plus L-TAP and 52 patients received WI. The primary end point was the efficacy in pain control at 6 h measured according to Numeric Rating Scale (NRS). Secondary aims evaluated pain control at 12, 24, 48 and 72 h and other short-term results related to pain management.
RESULTS


Estimation of pain intensity at 6 h was comparable between the two groups (p = 0.16) with a mean (95% CI) difference in pain scores of 0.94 (- 0.13 to 2.02). No differences in pain scores were observed at other interval times or considering analgesic consumption, return of bowel function, postoperative complications and length of hospital stay.
CONCLUSION


This study suggests that adding TAP block to WI does not affect pain control, amount of analgesics and other short-term outcomes.
TRIAL REGISTRATION


NCT03376048 ( https://www.clinicaltrials.gov ).",2020,"No differences in pain scores were observed at other interval times or considering analgesic consumption, return of bowel function, postoperative complications and length of hospital stay.
","['108 patients entered the study and 102 patients were analyzed; 50 patients received', 'patients undergoing laparoscopic colorectal resection', 'pain control after laparoscopic colorectal surgery', 'All patients with colorectal cancer and diverticular disease scheduled for laparoscopic resection at the Division of General and Hepatobiliary Surgery, University of Verona Hospital Trust, Verona, Italy and at the Colorectal Cancer Center, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea, between April 2018 and March 2019 were considered for the trial']","['WI plus L-TAP', 'pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block', 'wound infiltration (WI) compared to WI plus laparoscopic-assisted TAP block (L-TAP', 'Transversus abdominis plane (TAP)\xa0block']","['pain scores', 'pain control', 'pain intensity', 'pain management', 'Analgesic efficacy', 'analgesic consumption, return of bowel function, postoperative complications and length of hospital stay', 'efficacy in pain control at 6\xa0h measured according to Numeric Rating Scale (NRS']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",102.0,0.343165,"No differences in pain scores were observed at other interval times or considering analgesic consumption, return of bowel function, postoperative complications and length of hospital stay.
","[{'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Pedrazzani', 'Affiliation': 'Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy. corrado.pedrazzani@univr.it.'}, {'ForeName': 'Soo Yeun', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Colorectal Cancer Center, School of Medicine, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Conti', 'Affiliation': 'Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Turri', 'Affiliation': 'Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.'}, {'ForeName': 'Jun Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Colorectal Cancer Center, School of Medicine, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Colorectal Cancer Center, School of Medicine, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Polati', 'Affiliation': 'Anesthesia and Intensive Care Section, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Guglielmi', 'Affiliation': 'Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.'}, {'ForeName': 'Gyu Seog', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Colorectal Cancer Center, School of Medicine, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea.'}]",Surgical endoscopy,['10.1007/s00464-020-07771-6']
1888,32632491,"In an exploratory randomized, double-blind, placebo-controlled, cross-over study, psychoactive doses of intravenous delta-9-tetrahydrocannabinol fail to produce antinociceptive effects in healthy human volunteers.","RATIONALE


Animal studies and anecdotal human reports suggest that cannabinoids have antinociceptive effects. Controlled human studies have produced mixed results.
OBJECTIVES


We sought to reduce existing variability by investigating the effects of intravenous delta-9-tetrahydrocannabinol (THC) in several pain paradigms within the same human subjects, addressing some of the limitations to the published literature.
METHODS


In this exploratory randomized, double-blind, placebo-controlled, cross-over study, healthy human subjects received 0.01 mg/kg or 0.03 mg/kg intravenous THC or placebo (ethanol vehicle) infused over 10 min on three test days, each separated by at least 72 h. Capsaicin (250 μg) was injected intradermally to induce chemical pain and hyperalgesia. Four other forms of acute pain were induced: mechanical (von Frey filament), hot and cold (thermode), and electrical (pulse generator). Pain ratings were obtained before drug administration, at peak drug effects, and 2 h after drug administration and included both objective and subjective measures. THC drug effects and vital signs were also collected during experimental sessions. Nonparametric analysis with repeated measures was performed.
RESULTS


THC induced euphoria, perceptual and cognitive alterations, and tachycardia in a dose-related manner, but failed to have significant effects in experimentally induced acute chemical, mechanical, thermal, or electrical pain and capsaicin-induced hyperalgesia.
CONCLUSIONS


In this exploratory controlled study, intravenous THC lacked significant antinociceptive properties in experimental models of acute pain and capsaicin-induced hyperalgesia in healthy human subjects. Continued study of THC and other cannabinoids through high-quality, controlled studies in both healthy volunteers and patients with pain conditions is warranted to inform the growing demand for the clinical application of cannabinoids in pain management.",2020,"RESULTS


THC induced euphoria, perceptual and cognitive alterations, and tachycardia in a dose-related manner, but failed to have significant effects in experimentally induced acute chemical, mechanical, thermal, or electrical pain and capsaicin-induced hyperalgesia.
","['healthy human subjects received', 'healthy volunteers and patients with pain conditions', 'healthy human subjects', 'healthy human volunteers']","['THC', '0.01\xa0mg/kg or 0.03\xa0mg/kg intravenous THC or placebo (ethanol vehicle', 'intravenous delta-9-tetrahydrocannabinol', 'Capsaicin', 'placebo']","['Pain ratings', 'THC drug effects and vital signs', 'euphoria, perceptual and cognitive alterations, and tachycardia']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]",,0.281317,"RESULTS


THC induced euphoria, perceptual and cognitive alterations, and tachycardia in a dose-related manner, but failed to have significant effects in experimentally induced acute chemical, mechanical, thermal, or electrical pain and capsaicin-induced hyperalgesia.
","[{'ForeName': 'Emmanuelle A D', 'Initials': 'EAD', 'LastName': 'Schindler', 'Affiliation': 'Neurology Service, MS 127, Veterans Affairs (VA) Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT, 06516, USA. emmanuelle.schindler@yale.edu.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Schnakenberg Martin', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Sewell', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'DeForest', 'Affiliation': 'Neurology Service, MS 127, Veterans Affairs (VA) Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT, 06516, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Perrino', 'Affiliation': 'Anesthesia Service, VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Deepak C', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05595-9']
1889,32632501,The possibility of a transanal tube as an alternative to diverting stoma in terms of preventing severe postoperative anastomotic leakage after laparoscopic low anterior resection.,"PURPOSE


The purpose of this study was to reveal whether a transanal tube (TAT) could act as an alternative to a diverting stoma (DS) after laparoscopic low anterior resection.
PATIENTS AND METHODS


A total of 89 consecutive rectal cancer patients whose tumors were located within 15 cm from the anal verge who underwent laparoscopic low anterior resection without a DS at our institution between May 12, 2015 and August 31, 2019 were included. All patients received a postoperative Gastrografin enema study (GES) through a TAT between the 3rd and 10th postoperative day. We planned two study protocols. From May 12, 2015 to March 31, 2017, we conducted a second operation including a DS construction immediately when radiological anastomotic leakage (rAL) was detected (Group A, n=46). From April 1, 2017 to August 31, 2019, we continued TAT drainage even if rAL was detected and repeated the GES weekly until the rAL was healed (Group B, n=43).
RESULTS


In Group A (n=46), 14 cases of rAL were included, 11 of which underwent stoma construction. The remaining 3 patients who refused stoma construction were treated conservatively. In Group B (n=43) rAL was encountered in 10, and 7 of these patients were treated successfully by TAT continuous drainage. The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%) (p=0.028).
CONCLUSIONS


A TAT could act as a DS to mitigate the symptoms of anastomotic leakage after laparoscopic low anterior resection.",2020,The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%),"['after laparoscopic low anterior resection', '89 consecutive rectal cancer patients whose tumors were located within 15 cm from the anal verge who underwent laparoscopic low anterior resection without a DS at our institution between May 12, 2015 and August 31, 2019 were included', 'In Group A (n=46), 14 cases of rAL were included, 11 of which underwent stoma construction']","['TAT continuous drainage', 'transanal tube (TAT']","['severe postoperative anastomotic leakage', 'radiological anastomotic leakage (rAL', 'rate of DS', 'anastomotic leakage']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}]",89.0,0.0206708,The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%),"[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Hamada', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan. KGH03145@nifty.com.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Inada', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Surgery, Terada Hospital, Nabari, Mie, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Oishi', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Shigemitsu', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Sekimoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-020-03624-9']
1890,32632523,Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity.,"BACKGROUND


Due to the SARS-CoV2 pandemic, medical face masks are widely recommended for a large number of individuals and long durations. The effect of wearing a surgical and a FFP2/N95 face mask on cardiopulmonary exercise capacity has not been systematically reported.
METHODS


This prospective cross-over study quantitated the effects of wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask (ffpm) in 12 healthy males (age 38.1 ± 6.2 years, BMI 24.5 ± 2.0 kg/m 2 ). The 36 tests were performed in randomized order. The cardiopulmonary and metabolic responses were monitored by ergo-spirometry and impedance cardiography. Ten domains of comfort/discomfort of wearing a mask were assessed by questionnaire.
RESULTS


The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± 1.6 l/s; p < 0.001). The maximum power was 269 ± 45, 263 ± 42 and 277 ± 46 W with sm, ffpm and nm, respectively; p = 0.002; the ventilation was significantly reduced with both face masks (131 ± 28 vs 114 ± 23 vs 99 ± 19 l/m; p < 0.001). Peak blood lactate response was reduced with mask. Cardiac output was similar with and without mask. Participants reported consistent and marked discomfort wearing the masks, especially ffpm.
CONCLUSION


Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals. These data are important for recommendations on wearing face masks at work or during physical exercise.",2020,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","['12 healthy males (age 38.1\u2009±\u20096.2\xa0years, BMI 24.5\u2009±\u20092.0\xa0kg/m 2 ', 'healthy individuals']","['wearing a surgical and a FFP2/N95 face mask', 'wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask', 'surgical and FFP2/N95 face masks']","['Cardiac output', 'Peak blood lactate response', 'ventilation', 'pulmonary function parameters', 'cardiopulmonary exercise capacity', 'cardiopulmonary and metabolic responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.0184074,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany. sven.fikenzer@medizin.uni-leipzig.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lavall', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rudolph', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Klinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01704-y']
1891,32632561,Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial.,"To prospectively compare standard and valve-less insufflation systems on pneumoperitoneum-related complications in robotic-assisted laparoscopic partial nephrectomy. A prospective randomized controlled trial was conducted during a 1.5-year period to compare insufflation-related complications in partial nephrectomy surgery by a single surgeon. Thirty-one patients were recruited for each group: AirSeal insufflation system at 12 mmHg (AIS12), AirSeal at 15 mmHg (AIS15), and conventional insufflation system at 15 mmHg (CIS). Primary outcome assessed was rate of subcutaneous emphysema. Secondary outcomes included rates of pneumothorax, pneumomediastinum, shoulder pain scores, overall pain scores, pain medication usage, insufflation time, recovery room time, length of hospital stay and impact of surgical approach. Predictors for subcutaneous emphysema were assessed with univariate and multivariate logistic models. 93 patients with similar baseline characteristics were randomized into the three insufflation groups. Incidence of subcutaneous emphysema was lower in the AIS12 group compared to CIS (19% vs 48%, p = 0.03,). Mean pain score was less for AIS12 compared to CIS at 12 h (3.1 vs 4.4, p = 0.03). Shoulder pain was less in AIS12 and AIS15 groups compared to CIS at 8 h (AIS12 vs CIS: 0.6 vs 1.6, p = 0.01, AIS15 vs CIS: 0.6 vs 1.6, p = 0.02), and between AIS12 as compared to CIS at 12 h (0.4 vs 1.4, p = 0.003) postoperatively. There was no difference between morphine equivalent use, insufflation time, recovery room time, and length of hospital stay. Multivariable regression analysis showed AirSeal at 12 mmHg and the transperitoneal approach to be the only significant predictors for lower risk of developing subcutaneous emphysema (p < 0.001). Compared to standard insufflation, AirSeal insufflation at 12 mmHg was associated with reduced risk of developing subcutaneous emphysema in robotic partial nephrectomy. Furthermore, shoulder pain was reduced in both AirSeal groups compared to standard insufflation. The retroperitoneal approach increases the risk of developing subcutaneous emphysema.",2020,"Compared to standard insufflation, AirSeal insufflation at 12 mmHg was associated with reduced risk of developing subcutaneous emphysema in robotic partial nephrectomy.","['Thirty-one patients were recruited for each group', '93 patients with similar baseline characteristics', 'robotic partial nephrectomy']","['robotic-assisted laparoscopic partial nephrectomy', 'valve-less and standard insufflation', 'AirSeal insufflation system at 12\xa0mmHg (AIS12), AirSeal at 15\xa0mmHg (AIS15), and conventional insufflation system at 15\xa0mmHg (CIS', 'standard and valve-less insufflation systems', 'partial nephrectomy surgery']","['Mean pain score', 'morphine equivalent use, insufflation time, recovery room time, and length of hospital stay', 'lower risk of developing subcutaneous emphysema', 'rate of subcutaneous emphysema', 'Incidence of subcutaneous emphysema', 'Shoulder pain', 'rates of pneumothorax, pneumomediastinum, shoulder pain scores, overall pain scores, pain medication usage, insufflation time, recovery room time, length of hospital stay and impact of surgical approach', 'shoulder pain', 'risk of developing subcutaneous emphysema']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0038536', 'cui_str': 'Subcutaneous emphysema'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0025062', 'cui_str': 'Mediastinal emphysema'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",93.0,0.162221,"Compared to standard insufflation, AirSeal insufflation at 12 mmHg was associated with reduced risk of developing subcutaneous emphysema in robotic partial nephrectomy.","[{'ForeName': 'Tom S', 'Initials': 'TS', 'LastName': 'Feng', 'Affiliation': 'Swedish Medical Center, 1101 Madison St, Suite 1400, Seattle, WA, 98104, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Heulitt', 'Affiliation': 'Swedish Medical Center, 1101 Madison St, Suite 1400, Seattle, WA, 98104, USA.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Islam', 'Affiliation': 'Swedish Medical Center, 1101 Madison St, Suite 1400, Seattle, WA, 98104, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Porter', 'Affiliation': 'Swedish Medical Center, 1101 Madison St, Suite 1400, Seattle, WA, 98104, USA. porter@swedishurology.com.'}]",Journal of robotic surgery,['10.1007/s11701-020-01117-z']
1892,32632643,The Impact of Surgical Boot Camp and Subsequent Repetitive Practice on the Surgical Skills and Confidence of Residents.,"BACKGROUND


Boot camp can enable residents to acquire surgical skills and confidence, but they can lose these skills over time if they do not use them. The purpose of this study was to explore whether boot camp and subsequent repetitive practice could strengthen residents' clinical skills and self-confidence.
METHODS


This is a comparative study of surgical residents who were enrolled in our institution from 2016 to 2017. The residents in the experimental group (enrolled in 2017) received boot camp training and a year of repetitive practice. The control group (enrolled in 2016) only received routine residency training. The rotation assessment pass rates of the two groups during the first year of the residency training were compared. A survey was conducted at different points in time to investigate the influence of boot camp and repetitive practice on the confidence of the residents.
RESULTS


The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05). The residents' confidence in themselves improved significantly after the boot camp, and it was comparable to that of the residents in the control group after their first year of residency. The level of self-confidence of the experimental group was further improved after repetitive practice. Finally, residents in the experimental group received better evaluations by their colleagues than the control group received.
CONCLUSIONS


This study showed that boot camp can improve the surgical skills and confidence of residents and that repetitive practice can further strengthen them. Residents in the experimental group developed their self-confidence in boot camp, and it increased after repetitive practice.",2020,The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05).,"['surgical residents who were enrolled in our institution from 2016 to 2017', 'Residents']","['boot camp and subsequent repetitive practice', 'boot camp training', 'routine residency training', 'Surgical Boot Camp and Subsequent Repetitive Practice']","['level of self-confidence', 'rotation assessment pass rates', 'self-confidence', 'assessment pass rate']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0729274', 'cui_str': 'Boots - surgical'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0270523,The assessment pass rate of the experimental group was significantly higher than that of the control group (p < 0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Hucheng', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Haozhen', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China.""}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'He', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, No. 321 Zhongshan Road, Nanjing, 210008, Jiangsu, People's Republic of China. 2015455752@qq.com.""}]",World journal of surgery,['10.1007/s00268-020-05669-x']
1893,32632657,Correction to: Prebiotic effect of inulin‑type fructans on faecal microbiota and short‑chain fatty acids in type 2 diabetes: a randomised controlled trial.,The original version of this article unfortunately contained a mistake. The presentation of Fig. 4 was incorrect.,2020,The original version of this article unfortunately contained a mistake.,['type 2 diabetes'],['inulin‑type fructans'],['faecal microbiota and short‑chain fatty acids'],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",,0.0311723,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02314-0']
1894,32632661,Correction to: No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".",2020,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","['percutaneous palliation of malignant hilar biliary obstruction', 'malignant hilar biliary obstruction']",[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}]",[],[],,0.0447173,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-020-07029-8']
1895,32632732,Adapted ERAS Pathway Versus Standard Care in Patients Undergoing Emergency Small Bowel Surgery: a Randomized Controlled Trial.,"BACKGROUND


Emergency laparotomy for small bowel pathologies comprises a significant number of all emergency surgeries. Application of evidence-based adapted enhanced recovery after surgery (ERAS) protocol can potentially improve the perioperative outcome in these procedures.
AIMS


To determine the feasibility, safety, and efficacy of adapted ERAS pathway in emergency small bowel surgery.
METHODOLOGY


This was a single-center, prospective, open-labeled, superiority, randomized controlled trial. Patients suspected to have small bowel pathology by the emergency surgical team were randomized preoperatively into standard care and adapted ERAS group. Patients with American Society of Anesthesiologist class ≥ 3, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded. Primary outcome parameter was the length of hospitalization (LOH). Morbidity and other functional recovery parameters were also assessed.
RESULTS


Thirty-five patients were included in the adapted ERAS and standard care group. The laboratory and demographic variables were comparable. Patients in the ERAS group had significantly earlier recovery (days) in terms of first fluid diet (1.48 ± 0.18, p < 0.001), solid diet (2.11 ± 0.17, p < 0.001), time to first flatus (1.25 ± 0.24, p < 0.001), and first stool (1.8 ± 0.27, p < 0.001). Postoperative nausea, vomiting (RR 0.69, p = 0.19), pulmonary complications (RR 0.38, p = 0.16), superficial (RR 0.79, p = 0.33), and deep surgical site infections (RR 0.65, p = 0.39) were similar. Compared with the standard care group, ERAS group had significantly shorter LOH (8 ± 0.38 vs. 10.83 ± 0.42; Mean difference, 2.83 ± 0.56; p < 0.001).
CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.",2020,"CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","['Patients with American Society of Anesthesiologist class ≥\u20093, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded', 'Patients Undergoing Emergency Small Bowel Surgery', 'Patients suspected to have small bowel pathology by the emergency surgical team', 'Thirty-five patients were included in the adapted ERAS and standard care group', 'patients undergoing emergency small bowel surgery']","['Adapted ERAS Pathway Versus Standard Care', 'standard care and adapted ERAS', 'ERAS']","['time to first flatus', 'feasibility, safety, and efficacy', 'shorter LOH', 'Morbidity and other functional recovery parameters', 'pulmonary complications', 'length of hospitalization (LOH', 'deep surgical site infections', 'earlier recovery', 'Postoperative nausea, vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0740401', 'cui_str': 'Duodenal ulcer with perforation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0192571', 'cui_str': 'Operative procedure on small intestine'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",35.0,0.126187,"CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","[{'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Saurabh', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Subair', 'Initials': 'S', 'LastName': 'Mohsina', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Thulasingam', 'Initials': 'T', 'LastName': 'Mahalakshmy', 'Affiliation': 'Department of Preventive Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. drvikramkate@gmail.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04684-6']
1896,32632763,Low intensity treatment for clinically anxious youth: a randomised controlled comparison against face-to-face intervention.,"Methods to deliver empirically validated treatments for anxious youth that require fewer therapist resources (low intensity) are beginning to emerge. However, the relative efficacy of low-intensity treatment for youth anxiety against standard face-to-face delivery has not been comprehensively evaluated. Young people aged 6-16 years with a primary anxiety disorder (N = 281) were randomly allocated to treatment delivered either face-to-face or in a low-intensity format. Face-to-face treatment comprised ten, 60-min sessions delivered by a qualified therapist. Low intensity comprised information delivered in either printed (to parents of children under 13) or electronic (to adolescents aged 13 +) format and was supported by up to four telephone sessions with a minimally qualified therapist. Youth receiving face-to-face treatment were significantly more likely to remit from all anxiety disorders (66%) than youth receiving low intensity (49%). This difference was reflected in parents' (but not child) reports of child's anxiety symptoms and life interference. No significant moderators were identified. Low intensity delivery utilised significantly less total therapist time (175 min) than face-to-face delivery (897 min) and this was reflected in a large mean difference in therapy costs ($A735). Standard, face-to-face treatment for anxious youth is associated with significantly better outcomes than delivery of similar content using low-intensity methods. However, the size of this difference was relatively small. In contrast, low-intensity delivery requires markedly less time from therapists and subsequently lower treatment cost. Data provide valuable information for youth anxiety services.Clinical trial registration information: A randomised controlled trial of standard care versus stepped care for children and adolescents with anxiety disorders; https://anzctr.org.au/ ; ACTRN12612000351819.",2020,Low intensity delivery utilised significantly less total therapist time (175 min) than face-to-face delivery (897 min) and this was reflected in a large mean difference in therapy costs ($A735).,"['children and adolescents with anxiety disorders', 'Young people aged 6-16\xa0years with a primary anxiety disorder (N\u2009=\u2009281', 'clinically anxious youth']","['Low intensity treatment', 'telephone sessions with a minimally qualified therapist', 'standard care versus stepped care', 'face-to-face or in a low-intensity format']","['total therapist time', ""child's anxiety symptoms and life interference""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",,0.0476452,Low intensity delivery utilised significantly less total therapist time (175 min) than face-to-face delivery (897 min) and this was reflected in a large mean difference in therapy costs ($A735).,"[{'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney. NSW, 2109, Australia. Ron.Rapee@mq.edu.au.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Lyneham', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney. NSW, 2109, Australia.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Wuthrich', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney. NSW, 2109, Australia.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Chatterton', 'Affiliation': 'Deakin Health Economics, School of Health and Social Development, Deakin University Melbourne, VIC, 3125, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney. NSW, 2109, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney. NSW, 2109, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, School of Health and Social Development, Deakin University Melbourne, VIC, 3125, Australia.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01596-3']
1897,32632894,Temozolomide and seizure outcomes in a randomized clinical trial of elderly glioblastoma patients.,"INTRODUCTION


Tumor-related epilepsy may respond to chemotherapy. In a previously-published multi-centre randomized clinical trial of 562 elderly glioblastoma patients, temozolomide plus short-course radiotherapy conferred a survival benefit over radiotherapy alone. Seizure outcomes were not reported.
METHODS


We performed an unplanned secondary analysis of this trial's data. The trial design has been previously reported. Seizures were recorded by clinicians as adverse events and by patients in quality of life questionnaires. A Chi-square test of seizure rates between the two groups (α = 0.05) and a Kaplan-Meier estimator of time-to-first self-reported seizure were planned.
RESULTS


Almost all patients were followed until they died. In the radiotherapy alone group, 68 patients (24%) had a documented or self-reported seizure versus 83 patients (30%) in the temozolomide plus radiotherapy group, Chi-square analysis showed no difference (p = 0.15). Patients receiving radiotherapy alone tended to develop seizures earlier than those receiving temozolomide plus radiotherapy (p = 0.054). Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
CONCLUSIONS


This study was not powered to detect differences in seizure outcomes, but temozolomide seemed to have minimal impact on seizure control in elderly patients with glioblastoma.
CLINICAL TRIAL REGISTRATION


NCT00482677 2007-06-05.",2020,"Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
","['elderly glioblastoma patients', '562 elderly glioblastoma patients', 'elderly patients with glioblastoma']","['temozolomide plus short-course radiotherapy', 'temozolomide', 'Temozolomide', 'radiotherapy', 'temozolomide plus radiotherapy']","['seizure rates', 'develop seizures earlier', 'survival benefit', 'overall survival', 'Seizures', 'documented or self-reported seizure', 'quality of life questionnaires']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",562.0,0.441488,"Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Climans', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada. seth.climans@uhn.com.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Azienda Unità Sanitaria Locale - Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'University of Calgary, Calgary, Canada.'}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fay', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Laperriere', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Menten', 'Affiliation': 'University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Perry', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Roa', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg and Neurooncology Program, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Winch', 'Affiliation': ""The Canadian Cancer Trials Group, Queen's University, Kingston, Canada.""}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03573-x']
1898,32598683,[The effectiveness of complex therapy using the injectable form of chondroitin sulfate and sodium hyaluronate with osteoarthritis of the knee joint].,"AIM


The study on the effectiveness of complex therapy for osteoarthritis (OA) of the knee joint was conducted in real clinical practice.
MATERIALS AND METHODS


The survey involved 125 patients aged fr om 50 to 70 years (25 men and 100 women) with a diagnosis of knee joint OA (the III roentgenologic Kellgren-Lawrence stage).The average age of the patients was 62±3.21, the average duration of the disease - 9.4±2.8 years. Patients were randomly assigned to three groups of 35 people, the control group had 20 patients. Group 1 patients received non - steroidal anti - inflammatory drugs (NSAIDs) + Injectran(Chondroitin sulfate) 200 mg intramuscularly (I.M.) every other day No. 25.In group 2, patients received NSAIDs + Fermatron 1% 2 ml with an interval of 7 days intra - articularly (I.A.) No. 3. In group 3 - NSAIDs + Injectran 200 mg (I.M.) every other day No. 25 + Fermatron 1% 2 ml with an interval of 7 days (I.A.) No. 3. In the control group (20 people), patients received only NSAIDs. Evaluation of the symptoms was carried out using the WOMAC index before the start of thetherapy, after 8 and 12 weeks of treatment. The intensity of pain while walking was estimated on a visual analogue scale.
RESULTS


In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (p.",2019,"In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (","['125 patients aged fr om 50 to 70 years (25 men and 100 women) with a diagnosis of knee joint OA (the III roentgenologic Kellgren-Lawrence stage).The average age of the patients was 62±3.21, the average duration of the disease - 9.4±2.8 years', 'osteoarthritis (OA) of the knee joint was conducted in real clinical practice']","['chondroitin sulfate and sodium hyaluronate', 'non - steroidal anti - inflammatory drugs (NSAIDs) + Injectran(Chondroitin sulfate) 200 mg intramuscularly (I.M', 'complex therapy', 'NSAIDs + Fermatron']","['WOMAC index', 'intensity of pain while walking']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205483', 'cui_str': 'Radiologic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",125.0,0.018665,"In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Belyaeva', 'Affiliation': 'Tula State University, Medical Institute.'}, {'ForeName': 'O S', 'Initials': 'OS', 'LastName': 'Avdeeva', 'Affiliation': 'Tula State University, Medical Institute.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.05.000213']
1899,32598992,Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,,2020,,['adult patients with Fontan circulation'],['Inspiratory muscle training'],['exercise capacity and lung function'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197853', 'cui_str': 'Fontan Circuit'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0703325,,"[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Fritz', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany. Electronic address: fritz@dhm.mhn.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ewert', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Hager', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.038']
1900,32598997,The effect of low-volume high-intensity interval training on cardiovascular health outcomes in type 2 diabetes: A randomised controlled trial.,"BACKGROUND


Low-volume high-intensity interval training (HIIT) may be a time-efficient strategy that leads to similar or superior improvements in cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors when compared with moderate-intensity continuous training (MICT). Our study investigated the effect of low-volume HIIT or MICT versus sham placebo-control (PLA) on central arterial stiffness, hemodynamic responses, and CVD risk factors in adults with obesity and type 2 diabetes (T2D).
METHODS


Eligible participants were previously inactive adults with obesity and T2D. Individuals were randomly allocated to: i) HIIT (1 × 4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45 min of cycling at 60% VO 2peak ); or PLA. Training groups exercised thrice weekly for 12 weeks. Central arterial stiffness, hemodynamics and CVD risk factors were assessed at baseline and post-intervention. Analysis of covariance (ANCOVA) was used to examine changes following HIIT, MICT and PLA.
RESULTS


Thirty-five participants (age: 55.1 ± 1.4 years, BMI: 36.1 ± 0.8 kg/m 2 ) completed the study. A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .03), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s). There was a significant intervention effect for changes in V̇O 2peak  (p < .01), glycosylated hemoglobin (p = .03), systolic blood pressure (p < .01), and waist circumference (p = .03), which all improved following MICT or HIIT but not PLA; there was no difference between MICT and HIIT.
CONCLUSIONS


Twelve minutes of low-volume HIIT per week leads to improvements in central arterial stiffness and cardiovascular health in inactive individuals with obesity and T2D.",2020,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","['Eligible participants were previously inactive adults with obesity and T2D. Individuals', 'adults with obesity and type 2 diabetes (T2D', 'inactive individuals with obesity and T2D', 'Thirty-five participants (age: 55.1\u202f±\u202f1.4\u202fyears, BMI: 36.1\u202f±\u202f0.8\u202fkg/m 2 ) completed the study', 'type 2 diabetes']","['low-volume HIIT or MICT versus sham placebo-control (PLA', 'HIIT (1\u202f×\u202f4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45\u202fmin of cycling at 60% VO 2peak ); or PLA', 'low-volume high-intensity interval training', 'Low-volume high-intensity interval training (HIIT']","['waist circumference', 'Central arterial stiffness, hemodynamics and CVD risk factors', 'cardiovascular health outcomes', 'central arterial stiffness, hemodynamic responses, and CVD risk factors', 'cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors', 'V̇O 2peak', 'glycosylated hemoglobin', 'systolic blood pressure', 'central arterial stiffness and cardiovascular health', 'pulse wave velocity (PWV']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",,0.0978978,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","[{'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia. Electronic address: kim.way@deakin.edu.au.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Sabag', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Rachelle N', 'Initials': 'RN', 'LastName': 'Sultana', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Baker', 'Affiliation': 'School of Exercise Science, Australian Catholic University, Strathfield, NSW, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Lanting', 'Affiliation': 'School of Health Sciences, University of Newcastle, Ourimbah, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerofi', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Vivienne H', 'Initials': 'VH', 'LastName': 'Chuter', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia; Central Clinical School, School of Medicine, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.019']
1901,32609186,Effects of desensitizing products on the reduction of pain sensitivity caused by in-office tooth bleaching: a 24-week follow-up.,"OBJECTIVE


To clinically assess the effect of desensitizing gels and dentifrices on the reduction in pain sensitivity and color variation during tooth bleaching.
METHODOLOGY


A total of 108 volunteers were randomly separated into the following groups of n=12: GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate; and NA/PN-potassium nitrate and arginine/potassium nitrate. Sensitivity was assessed with the numerical analogue scale, and color variation (ΔE) was measured with a spectrophotometer. The sensitivity values obtained were subjected to a multivariate analysis of variance (MANOVA) and color variation values were subjected to a randomized analysis of variance (p<0.05).
RESULTS


The NF/AC, NA/AC, NF/PN, and NA/PN groups presented lower sensitivity values and reduced sensitivity compared to those of the other groups throughout the clinical sessions. None of the groups showed sensitivity at the 24-week assessment. Statistically, no significant difference were observed in the color values among the groups four weeks after the beginning of bleaching (p=0.074). Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
CONCLUSION


Our results indicate that adding NF/S, NA/S, NF/AC, and NA/AC desensitizers to tooth bleaching protocols reduces pain sensitivity without affecting its effectiveness.",2020,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
",['108 volunteers were randomly separated into the following groups of n=12'],"['desensitizing gels and dentifrices', 'fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate', 'desensitizing products', 'GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium']","['color values', 'numerical analogue scale, and color variation (ΔE', 'sensitivity values and reduced sensitivity', 'pain sensitivity', 'pain sensitivity and color variation', 'Sensitivity']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",108.0,0.0167949,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning.
","[{'ForeName': 'Josué Junior Araujo', 'Initials': 'JJA', 'LastName': 'Pierote', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Lucia Trazzi', 'Initials': 'LT', 'LastName': 'Prieto', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Carlos Tadeu Dos Santos', 'Initials': 'CTDS', 'LastName': 'Dias', 'Affiliation': 'Universidade de São Paulo, Escola Superior de Agricultura Luiz de Queiroz, Departamento de Engenharia Agronômica, Piracicaba, Brasil.'}, {'ForeName': 'João Victor Frazão', 'Initials': 'JVF', 'LastName': 'CÂmara', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Ciências Biológicas, Bauru, Brasil.'}, {'ForeName': 'Débora Alves Nunes Leite', 'Initials': 'DANL', 'LastName': 'Lima', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Flávio Henrique Baggio', 'Initials': 'FHB', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Luis Alexandre Maffei Sartini', 'Initials': 'LAMS', 'LastName': 'Paulillo', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0755']
1902,32609294,Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.,"Importance


Facilitating the development of safe and effective medications for schizophrenia is a public health imperative.
Objectives


To evaluate the association of shortening randomized clinical trial (RCT) duration with the modification of the Positive and Negative Syndrome Scale (PANSS) for the design of RCTs of medications for schizophrenia and to offer perspective on an alternative regulatory pathway to the historically accepted trial duration and response assessment.
Data Sources


A database was created consisting of clinical trial data from 32 placebo-controlled RCTs of 8 atypical antipsychotic drugs approved by the US Food and Drug Administration (FDA) between January 1, 2001, and December 31, 2015. The database included information on total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs).
Study Selection


All clinical trials submitted to 8 new drug applications of atypical antipsychotic drugs were selected.
Data Extraction and Synthesis


Quality control checks were performed to ensure that the collected data were consistent with the reported results of each trial. Data were collected from March 15, 2015, to September 30, 2015. Data analysis was conducted from October 1, 2015, to June 20, 2016.
Main Outcomes and Measures


The following analyses were performed: (1) longitudinal assessment of mean change from baseline in total PANSS score, (2) correlation analyses between change from baseline in total PANSS score at week 6 and earlier time points, (3) concordance analyses of outcomes across trials between week 6 and earlier time points using total PANSS and modified PANSS, and (4) analyses of time course of treatment-emergent AEs.
Results


The final database contained data from 14 219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals. The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years. Statistically significant separation between treatment response and placebo response was observed after 1 week of treatment. The overall concordance rate across treatment groups steadily increased from week 1 to week 4 (68.0% for week 1, 74.0% for week 2, 83.0% for week 3, and 93.0% for week 4). Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6. The overall concordance rate between change from baseline in the modified PANSS score and change from baseline in the total PANSS score was 93.0% (80 of 86 treatment groups) at week 4 and 97.7% (84 of 86 treatment groups) at week 6. Shortening the trial duration to 4 weeks increased the required sample size to 502 participants. Using the modified PANSS as the end point, the sample size for a 4-week trial was 402 participants and 296 participants for a 6-week trial.
Conclusions and Relevance


Findings from this analysis suggest that there is the potential to streamline the design of schizophrenia drug clinical trials. Trial sponsors may consider incorporating these strategies and are encouraged to consult with the FDA early in the drug development process.",2020,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","['The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years', '402 participants and 296 participants for a 6-week trial', '14\u202f219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals']",[],"['total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs', 'overall concordance rate', 'total PANSS score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",14219.0,0.0619414,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","[{'ForeName': 'Islam R', 'Initials': 'IR', 'LastName': 'Younis', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Mathis', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Uppoor', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Farchione', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1596']
1903,32609313,Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia.,"Importance


Additional lipid-lowering therapy options are needed for patients who cannot achieve sufficient decreases in low-density lipoprotein cholesterol (LDL-C) levels using statins alone or for those who are statin intolerant.
Objective


To conduct a pooled analysis of phase 3 randomized clinical trials of bempedoic acid vs placebo.
Design, Setting, and Participants


This analysis pooled data from 4 double-blind, placebo-controlled randomized clinical trials conducted from 2016 to 2018. Patients were enrolled in North America and Europe. Eligibility criteria included hypercholesterolemia while receiving stable lipid-lowering therapy and high cardiovascular risk or hypercholesterolemia and statin intolerance.
Interventions


Patients were randomized 2:1 to bempedoic acid, 180 mg (n = 2425), or placebo (n = 1198) once daily for 12 to 52 weeks.
Main Outcomes and Measures


Primary efficacy end point was percentage change from baseline in LDL-C level at week 12 in the intention-to-treat population. Patients were parsed into 2 groups according to enrollment criteria: (1) patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) or with heterozygous familial hypercholesterolemia (HeFH) or with both and receiving statins and (2) patients with hypercholesterolemia who were statin intolerant receiving maximally tolerated statins.
Results


In this analysis of 3623 patients, the overall mean (SD) patient age was 65.5 (9.2) years (similar in both pools). Among patients with ASCVD or HeFH or both, the mean (SD) baseline LDL-C level was 107.6 (32.7) mg/dL. At week 12, the LDL-C level percentage change from baseline was -16.0% with bempedoic acid vs 1.8% with placebo (difference, -17.8%; 95% CI, -19.5% to -16.0%; P < .001). Patients with statin intolerance had a mean (SD) baseline LDL-C level of 144.4 (38.8) mg/dL. The percentage changes in LDL-C levels at week 12 were -23.0% in the bempedoic acid group and 1.5% in the placebo group (difference, -24.5%; 95% CI, -27.8% to -21.1%; P < .001). The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24). Decreases in non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein levels were greater with bempedoic acid vs placebo. Treatment-emergent adverse events associated more frequently with bempedoic acid than with placebo included increased blood uric acid level (2.1% vs 0.5%), gout (1.4% vs 0.4%), decreased glomerular filtration rate (0.7% vs <0.1%), and increased levels of hepatic enzymes (2.8% vs 1.3%).
Conclusions and Relevance


Bempedoic acid added to maximally tolerated statins, including moderate- or high-intensity statins or no background statin, was associated with decreased LDL-C levels vs placebo in patients with hypercholesterolemia with an acceptable safety profile. As a nonstatin adjunct or statin alternative, bempedoic acid has potential for use in a broad spectrum of patients.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02666664, NCT02991118, NCT03001076, and NCT02988115.",2020,"The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24).","['Patients With Hypercholesterolemia', 'patients with hypercholesterolemia', 'Patients were enrolled in North America and Europe', '3623 patients, the overall mean (SD) patient age was 65.5 (9.2) years (similar in both pools', 'Patients were parsed into 2 groups according to enrollment criteria: (1) patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) or with heterozygous familial hypercholesterolemia (HeFH) or with both and receiving statins and (2) patients with hypercholesterolemia who were statin intolerant receiving maximally tolerated statins', 'Eligibility criteria included hypercholesterolemia while receiving stable lipid-lowering therapy and high cardiovascular risk or hypercholesterolemia and statin intolerance']","['Bempedoic Acid Administration With Atherogenic Lipid Levels', 'bempedoic acid vs placebo', 'bempedoic acid', 'placebo']","['LDL-C level', 'blood uric acid level', 'low-density lipoprotein cholesterol (LDL-C) levels', 'LDL-C levels', 'non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein levels', 'glomerular filtration rate', 'mean (SD) baseline LDL-C level', 'LDL-C levels with bempedoic acid', 'levels of hepatic enzymes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0373739', 'cui_str': 'Blood uric acid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",3623.0,0.428465,"The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24).","[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Knight Cardiovascular Institute, School of Medicine, Oregon Health & Science University, Portland.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Gotto', 'Affiliation': 'Cardiovascular Unit, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Polyclinic for Cardiology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care and Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Flaim', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan and IRCCS Multimedica, Milan, Italy.'}]",JAMA cardiology,['10.1001/jamacardio.2020.2314']
1904,32604401,Using prefrontal transcranial direct current stimulation (tDCS) to enhance proactive cognitive control in schizophrenia.,"The goal of this study was to use transcranial direct current stimulation (tDCS) to examine the role of the prefrontal cortex (PFC) in neural oscillatory activity associated with proactive cognitive control in schizophrenia. To do so, we tested the impact of PFC-targeted tDCS on behavioral and electrophysiological markers of proactive cognitive control engagement in individuals with schizophrenia. Using a within-participants, double-blinded, sham-controlled crossover design, we recorded EEG while participants with schizophrenia completed a proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20 min of active prefrontal stimulation at 2 mA or sham stimulation. We hypothesized that active stimulation would enhance proactive cognitive control, leading to changes in behavioral performance on the DPX task and in activity in the gamma frequency band during key periods of the task designed to tax proactive cognitive control. The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control. These findings, considered alongside our previous work in healthy adults, provides novel support for the role gamma oscillations in proactive cognitive control and they suggest that frontal tDCS may be a promising approach to enhance proactive cognitive control in schizophrenia.",2020,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","['healthy adults', 'schizophrenia', 'individuals with schizophrenia', 'participants with schizophrenia completed a']","['transcranial direct current stimulation (tDCS', 'proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20\u2009min of active prefrontal stimulation at 2\u2009mA or sham stimulation', 'PFC-targeted tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['pattern of error rates and increases in EEG gamma power'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0402734,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Boudewyn', 'Affiliation': 'University of California, Santa Cruz, CA, USA. mboudewyn@ucsc.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scangos', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Charan', 'Initials': 'C', 'LastName': 'Ranganath', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'University of California, Davis, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0750-8']
1905,31825020,Three-Month Effect of Silver Diamine Fluoride (SDF) in Salivary Levels of Streptococcus Mutans in Children. An Exploratory Trial.,"PURPOSE


The aim of this exploratory trial was to compare the 3-month effect of two antimicrobials on the salivary levels of Streptococcus mutans (SM) in children.
MATERIALS AND METHODS


Ninety school children aged 6-10 years participated. They were divided into two groups according to treatment used: 1% chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF). Saliva for SM colony forming unit (CFU)/ml counting was harvested in four periods: baseline (prior to antimicrobials); P1 (24 h after antimicrobial therapy); P30 (30 days after antimicrobial therapy); and P90 (90 days after antimicrobial therapy). CFU/ml data was submitted to repeated measures by analysis of variance (ANOVA).
RESULTS


Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline. No influence of antimicrobials or interactions of factors were detected (p >0.05). P30 presented the lowest levels of SM and at P90, SM levels were similar to P1 but still lower than the baseline observations. SDF and CHX presented a similar effect on SM within each period of evaluation (p = 0.65).
CONCLUSION


It was concluded that 30% SDF presents similar antimicrobial effects as 1% CHX over time. SDF might be used as an adjunctive therapy for controlling dental caries in children.",2020,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","['Ninety school children aged 6-10 years participated', 'Salivary Levels of Streptococcus Mutans in Children', 'children']","['Silver Diamine Fluoride (SDF', 'chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF']","['lowest levels of SM and at P90, SM levels', 'antimicrobial effects', 'salivary levels of Streptococcus mutans (SM']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",90.0,0.0577897,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","[{'ForeName': 'Marta Diogo', 'Initials': 'MD', 'LastName': 'Garrastazu', 'Affiliation': ''}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': ''}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Rocha', 'Affiliation': ''}, {'ForeName': 'Michele Baffi', 'Initials': 'MB', 'LastName': 'Diniz', 'Affiliation': ''}, {'ForeName': 'Taciana Marco Ferraz', 'Initials': 'TMF', 'LastName': 'Caneppele', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43360']
1906,32612104,Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study.,"BACKGROUND


Laparoscopic appendectomy (LA) is a widely used surgical procedure. Patients often suffer from considerable postoperative pain and indigestion, which prolongs their in-hospital stay. Almost 10% of patients develop postoperative complications. The enhanced recovery after surgery (ERAS) program has proven its efficacy in elective surgery and could hypothetically improve LA outcomes. Currently, there is no ERAS program for LA.
METHODS


A modified ERAS (mERAS) protocol was studied in a prospective, randomized nonblinded clinical trial. The mERAS group consisted of 50 patients; the control group, of 54 patients. The mERAS protocol included a patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet. The primary outcome was postoperative length of stay (pLOS).
RESULTS


Modified protocol reduced median pLOS to 1.25 days vs 2 days in the controls (p < 0.0001). Twenty-one (42%) mERAS patients and 4 (7.4%) controls were discharged within 24 h (p < 0.001) after surgery; 0 readmissions were reported. Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 h, 2 h, 6 h, 12 h and 24 h after surgery: 2.33 ± 2.12 vs 4.19 ± 2.08 (p < 0.0001), 2.27 ± 1.91 vs 4.02 ± 1.89 (p < 0.0001), 2.28 ± 1.98 vs 3.70 ± 1.57 (p = 0.0001), 1.98 ± 1.72 vs 3.43 ± 1.54 (p < 0.0001) and 1.80 ± 1.74 vs 3.00 ± 1.27 (p = 0.032), respectively)]. The severity of shoulder and neck pain was lower but its incidence was similar. Peristalsis recovery was achieved earlier in the study group (median (min-max))-mERAS 7 (2-34) h vs control 11 (3-43) h; p = 0.009) but did not affect the time of the first flatus 23 (2-72) h vs 29 (6-70) h, respectively; p = 0.499).
CONCLUSIONS


The modified ERAS program for LA has advantages over the traditional approach.
REGISTRATION


This trial was registered at ClinicalTrials.gov as NCT03754777 (27/11/2018).",2020,Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 ,['laparoscopic appendectomy'],"['patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet', 'Laparoscopic appendectomy (LA']","['Peristalsis recovery', 'postoperative length of stay (pLOS', 'postoperative complications', 'Postoperative pain intensity assessed on the visual analogue scale', 'severity of shoulder and neck pain', 'postoperative pain and indigestion', 'median pLOS']","[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.166543,Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 ,"[{'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Nechay', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sazhin', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Titkova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital #1, Moscow, Russia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Anurov', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Melnikov-Makarchuk', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital Named After V.M. Buyanov, Moscow, Russia. worker.gq@yandex.ru.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tyagunov', 'Affiliation': 'Pirogov Russian National Research Medical University, State Clinical Hospital Named After V.M. Buyanov, Moscow, Russia.'}]",Scientific reports,['10.1038/s41598-020-67591-5']
1907,32612186,"Avocado (Persea americana) pulp improves cardiovascular and autonomic recovery following submaximal running: a crossover, randomized, double-blind and placebo-controlled trial.","Previous studies have demonstrated that regular avocado consumption presents advantageous effects on cardiovascular system. However, little attention has been paid to the use of avocado as a dietary supplement, in particular, for individuals involved in physical exercise training. Therefore, this study aims to evaluate the effect of acute avocado pulp intake on cardiovascular and autonomic recovery subsequent to moderate exercise. Using a crossover, randomized, double-blind and placebo-controlled trial design, 16 healthy female adults underwent two protocols: Avocado pulp (600 mg in capsule) and placebo (600 mg starch in capsule). After the ingestion of Avocado pulp or placebo, the subjects were seated for 60 min at rest, followed by running on a treadmill at a submaximal level and then remained seated for 60 min during recovery from the exercise. Heart rate (HR), heart rate variability (HRV) [rMSSD, SD1, HF (ms 2 )] and skin conductance were evaluated before and during exercise, as well as during recovery. HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise. In conclusion, avocado pulp improved cardiovascular and autonomic recovery after exercise, suggesting a reduced risk of cardiovascular events after exertion. The current results support the beneficial effects of ingestion of avocado prior to submaximal treadmill running.",2020,"HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise.",['16 healthy female adults underwent two protocols'],"['placebo', 'Avocado pulp or placebo', 'Avocado pulp (600\xa0mg in capsule) and placebo', 'Avocado (Persea americana) pulp', 'acute avocado pulp intake']","['HR, systolic blood pressure, HRV and skin conductance', 'Heart rate (HR), heart rate variability (HRV) [rMSSD, SD1, HF (ms 2 )] and skin conductance', 'risk of cardiovascular events', 'cardiovascular and autonomic recovery']","[{'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949120', 'cui_str': 'Persea americana'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",16.0,0.480823,"HR, systolic blood pressure, HRV and skin conductance recovered faster when subjects were given avocado pulp prior to exercise.","[{'ForeName': 'Fernando H', 'Initials': 'FH', 'LastName': 'Sousa', 'Affiliation': 'Department of Morphology and Physiology, University Health Center ABC, Santo Andre, SP, Brazil.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil. vitor.valenti@marilia.unesp.br.'}, {'ForeName': 'Leticia C', 'Initials': 'LC', 'LastName': 'Pereira', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Rafaela R', 'Initials': 'RR', 'LastName': 'Bueno', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Prates', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Akimoto', 'Affiliation': 'Post-Graduate Program in Physical Therapy, Sao Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Autonomic Nervous System Center (CESNA), Sao Paulo State University (UNESP), Av. Hygino Muzzi Filho, 737, Mirante, 17, Marilia, SP, 525-900, Brazil.'}, {'ForeName': 'Joice A T', 'Initials': 'JAT', 'LastName': 'Amaral', 'Affiliation': 'Department of Pediatric, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'de Abreu', 'Affiliation': 'Department of Morphology and Physiology, University Health Center ABC, Santo Andre, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67577-3']
1908,32612194,Sub-maximal endurance exercise does not mediate alterations of somatosensory thresholds.,"Physical exercise has been shown to alter sensory functions, such as sensory detection or perceived pain. However, most contributing studies rely on the assessment of single thresholds, and a systematic testing of the sensory system is missing. This randomised, controlled cross-over study aims to determine the sensory phenotype of healthy young participants and to assess if sub-maximal endurance exercise can impact it. We investigated the effects of a single bout of sub-maximal running exercise (30 min at 80% heart rate reserve) compared to a resting control in 20 healthy participants. The sensory profile was assessed applying quantitative sensory testing (QST) according to the protocol of the German Research Network on Neuropathic Pain. QST comprises a broad spectrum of thermal and mechanical detection and pain thresholds. It was applied to the forehead of study participants prior and immediately after the intervention. Time between cross-over sessions was one week. Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds. The sensory phenotypes did not indicate any clinically meaningful deviation of sensory function. The alteration of sensory thresholds needs to be carefully interpreted, and only systematic testing allows an improved understanding of mechanism. In this context, sub-maximal endurance exercise is not followed by a change of thermal and mechanical sensory function at the forehead in healthy volunteers.",2020,Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds.,"['healthy young participants', 'healthy volunteers', '20 healthy participants']","['Sub-maximal endurance exercise', 'sub-maximal endurance exercise', 'sub-maximal running exercise', 'Physical exercise', 'QST']",['thermal or mechanical sensory function'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",20.0,0.0441582,Sub-maximal endurance exercise did not significantly alter thermal or mechanical sensory function (time × group analysis) in terms of detection and pain thresholds.,"[{'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Kortenjann', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe-University of Frankfurt, Ginnheimer Landstr. 39, 60487, Frankfurt am Main, Germany. Johannes.fleckenstein@sport.uni-frankfurt.de.'}]",Scientific reports,['10.1038/s41598-020-67700-4']
1909,32613402,"Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial.","BACKGROUND


The postnatal intestinal colonization of human milk-fed and formula-fed infants differs substantially, as does the susceptibility to infectious diseases during infancy. Specific ingredients in human milk, such as prebiotic human milk oligosaccharides and a specifically structured fat composition with high proportion of beta-palmitic acid (beta-PA) promote the growth of intestinal bifidobacteria, which are associated with favorable effects on infants' health. The present study investigates whether addition of prebiotic galactooligosaccharides (GOS) in combination with higher amounts of beta-PA from cow's milk fat in infant formula positively affects gut microbiota and the incidence of infections in formula-fed infants.
METHODS


In a double-blind controlled trial, formula-fed infants were randomly assigned to either receive an experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement (0.5 g GOS/100 ml), or a standard infant formula with low beta-PA (< 10%), without prebiotics. A breast-fed reference group was also enrolled. After 12 weeks, fecal samples were collected to determine the proportion of fecal bifidobacteria. The number of infections during the first year of life was recorded.
RESULTS


After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001). The incidence of gastrointestinal or other infections during the first year of life did not differ between groups.
CONCLUSIONS


The combination of higher amounts of beta-PA plus GOS increased significantly the proportion of fecal bifidobacteria in formula-fed infants, but did not affect the incidence of infections.
TRIAL REGISTRATION


The study protocol was registered with Clinical Trials (Protocol Registration and Results System Trial ID: NCT01603719 ) on 05/15/2012 (retrospectively registered).",2020,"After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001).",['formula-fed infants'],"[""experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement"", 'prebiotic galactooligosaccharides (GOS']","['fecal bifidobacteria', 'proportion of fecal bifidobacteria', 'incidence of infections', 'number of infections', 'incidence of gastrointestinal or other infections']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.274988,"After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001).","[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Nomayo', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany. Antonia.nomayo@jsd.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schwiertz', 'Affiliation': 'Institute of Microecology, Herborn, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Department of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Timme', 'Affiliation': 'Department of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zelenka', 'Affiliation': 'DMK Baby GmbH, Bremen, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Tvrdik', 'Affiliation': 'Department of Computer Sciences, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jochum', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.'}]",Molecular and cellular pediatrics,['10.1186/s40348-020-00098-1']
1910,32609946,Nasal high-frequency percussive ventilation vs nasal continuous positive airway pressure in newborn infants respiratory distress: A cross over clinical trial.,"OBJECTIVE


To determine if nasal high-frequency percussive ventilation (nHFPV) to manage neonatal respiratory distress decreases the regional cerebral oxygen saturation (rScO 2  ) compared to nasal continous positive airway pressure (nCPAP).
STUDY DESIGN


A prospective, randomized, monocentric, open-label, noninferiority crossover trial. Newborns of gestational age (GA) ≥ 33 weeks exhibiting persistent respiratory distress after 10 minutes of life were treated with nHFPV and nCPAP, in succession and in random order. The primary endpoint was the mean rScO 2  , as revealed by near-infrared spectroscopy (NIRS).
RESULTS


Forty-nine newborns were randomized; the mean GA and birth weight was 36.4 ± 1.9 weeks and 2718 ± 497 g. The mean rScO 2  difference during the last 5 minutes of each ventilation mode (nHFPV minus nCPAP) was -0.7 ± 5.4% (95% confidence interval (CI) -2.25; 0.95%).
CONCLUSION


In our study on newborns of GA ≥33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.",2020,"In our study on newborns of GA ≥ 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.","['Forty-nine newborns were randomized; the mean GA and birth weight were 36.4 ± 1.9 weeks and 2,718 ± 497 g', 'newborn infants respiratory distress', 'Newborns of gestational age (GA']","['nHFPV and nCPAP', 'nasal high-frequency percussive ventilation (nHFPV', 'Nasal high-frequency percussive ventilation versus nasal continuous positive airway pressure']","['respiratory distress, cerebral oxygenation via nHFPV', 'mean rScO 2  , as revealed by near-infrared spectroscopy (NIRS', 'regional cerebral oxygen saturation (rScO 2  ', 'respiratory distress']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}]",49.0,0.114114,"In our study on newborns of GA ≥ 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Renesme', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dumas de la Roque', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': 'Pôle de Santé Publique, Clinical Epidemiology Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Chevrier', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rebola', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cramaregeas', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Benard', 'Affiliation': 'Pôle de Santé Publique, Clinical Epidemiology Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Elleau', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tandonnet', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, Bordeaux, France.'}]",Pediatric pulmonology,['10.1002/ppul.24935']
1911,32610246,Structure and process associated with the efficiency of intensive care units in low-resource settings: An analysis of the CHECKLIST-ICU trial database.,"PURPOSE


Characteristics of structure and process impact ICU performance and the outcomes of critically ill patients. We sought to identify organizational characteristics associated with efficient ICUs in low-resource settings.
MATERIALS AND METHODS


This is a secondary analysis of a multicenter cluster-randomized clinical trial in Brazil (CHECKLIST-ICU). Efficient units were defined by standardized mortality ratio (SMR) and standardized resource use (SRU) lower than the overall medians and non-efficient otherwise. We used a regularized logistic regression model to evaluate associations between organizational factors and efficiency.
RESULTS


From 118 ICUs (13,635 patients), 47 units were considered efficient and 71 non-efficient. Efficient units presented lower incidence rates (median[IQR]) of central line-associated bloodstream infections (4.95[0.00-22.0] vs 6.29[0.00-25.6], p = .04), utilization rates of mechanical ventilation (0.41[0.07-0.73] vs 0.58[0.19-0.82], p < .001), central venous catheter (0.67[0.15-0.98] vs 0.78[0.33-0.98], p = .04), and indwelling urinary catheter (0.62[0.22-0.95] vs 0.76[0.32-0.98], p < .01) than non-efficient units. The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
CONCLUSIONS


In low-resource settings, active surveillance of nosocomial infections and the utilization of invasive devices were associated with efficiency, supporting the management and evaluation of performance indicators as a starting point for improvement in ICU.",2020,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","['critically ill patients', 'low-resource settings', 'From 118 ICUs (13,635 patients']",[],"['utilization of central venous catheters', 'utilization rates of mechanical ventilation', 'central venous catheter', 'standardized mortality ratio (SMR) and standardized resource use (SRU', 'incidence rates (median[IQR]) of central line-associated bloodstream infections', 'indwelling urinary catheter']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4517542', 'cui_str': '118'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0521197', 'cui_str': 'Indwelling urinary catheter'}]",,0.219858,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","[{'ForeName': 'Leonardo S L', 'Initials': 'LSL', 'LastName': 'Bastos', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': ""Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.'}, {'ForeName': 'Jorge I F', 'Initials': 'JIF', 'LastName': 'Salluh', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil; Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: fernando.bozza@ini.fiocruz.br.""}]",Journal of critical care,['10.1016/j.jcrc.2020.06.008']
1912,32610342,Hepcidin is a relevant iron status indicator in infancy: results from a randomized trial of early vs. delayed cord clamping.,"BACKGROUND


We aimed to evaluate whether serum hepcidin is a useful indicator of iron status in infants.
METHODS


Term infants (n = 400) were randomized to delayed (≥180 s) or early (≤10 s) cord clamping (CC). Iron status was assessed at 4 and 12 months. In all cases with iron depletion or iron deficiency (ID) (as defined in ""Methods"") (n = 30) and 97 randomly selected iron-replete infants, we analyzed hepcidin and explored its correlation to the intervention, iron status, and perinatal factors.
RESULTS


Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months. Median (2.5th-97.5th percentile) hepcidin in non-ID infants in the delayed CC group (suggested reference) was 64.5 (10.9-142.1), 39.5 (3.5-157.7), and 32.9 (11.2-124.2) ng/mL in the cord blood and at 4 and 12 months, respectively. The value of 16 ng/mL was a threshold detecting all cases of iron depletion/ID at 4 months. No similar threshold for ID was observed at 12 months. The strongest predictor of hepcidin at both ages was ferritin.
CONCLUSIONS


Hepcidin is relevant as iron status indicator in early infancy and may be useful to detect ID. Levels <16 ng/mL at 4 months of age indicates ID.
IMPACT


Serum hepcidin is a relevant indicator of iron status in early infancy.Normal reference in healthy infants is suggested in this study.Serum hepcidin may be useful in clinical practice to detect iron deficiency.",2020,"RESULTS


Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months.","['Term infants (n\u2009=\u2009400', 'infancy', 'In all cases with iron depletion or iron deficiency (ID) (as defined in ""Methods"") (n\u2009=\u200930) and 97 randomly selected iron-replete infants', 'infants', 'healthy infants']",['Hepcidin'],"['Levels', 'Serum hepcidin concentrations']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",400.0,0.122746,"RESULTS


Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months.","[{'ForeName': 'Staffan K', 'Initials': 'SK', 'LastName': 'Berglund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden. staffan.berglund@umu.se.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Chmielewska', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Domellöf', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences Lund, Pediatrics, Lund University, Lund, Sweden.'}]",Pediatric research,['10.1038/s41390-020-1045-9']
1913,32611117,Does following optimized routes for single cars improve car routing?,"We study the impact of deserting a pre-established path, determined by a navigation software, on the overall city traffic. To do so, we consider a cellular automaton model for vehicular traffic, where the cars travel between two randomly assigned points in the city following three different navigation strategies based on the minimization of the individual paths or travel times. We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.",2020,"We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.",[],[],[],[],[],[],,0.0339853,"We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carrasco', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Medina', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rogan', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Valdivia', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}]","Chaos (Woodbury, N.Y.)",['10.1063/1.5145309']
1914,32633157,Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: Insights from the 24 month TRANSFORM study.,"OBJECTIVES


In TRANSFORM,  de novo  kidney transplant recipients received either everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI) at standard EVR pre-dose concentrations of 3-8 ng/mL or mycophenolic acid plus standard-exposure CNI (MPA+sCNI). The authors analyzed the incidence of wound healing adverse events (WHAEs) over the 2-year study period.
METHODS


Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids.
RESULTS


The safety population consisted of 2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012). The proportion of patients with at least 1 WHAE was comparable between EVR+rCNI and MPA+sCNI treatment groups [20.6% vs. 17.3%; risk ratio (RR): 1.19; 95% confidence interval (CI): 0.99, 1.43] at month 24. The numerical difference between EVR+rCNI and MPA+sCNI was mainly caused by an increased proportion of EVR patients with lymphocele and wound dehiscence [7.5% vs. 5.1% (RR: 1.46; 95% CI: 1.04, 2.05) and 3.9 vs. 1.8% (RR: 2.22; 95%CI: 1.28, 3.84), respectively].
CONCLUSION


The immediate introduction of EVR+rCNI after kidney transplantation was associated with an overall comparable incidence of WHAEs versus current standard-of-care over the 24-month study period. There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups.
CT.GOV IDENTIFIER


NCT01950819.",2020,"There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups.
","['2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012', 'kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care', 'Patients']","['everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI', 'EVR+rCNI', 'EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids', 'mycophenolic acid plus standard-exposure CNI (MPA+sCNI']","['proportion of EVR patients with lymphocele and wound dehiscence', 'relative risk of experiencing lymphocele and wound dehiscence', 'Wound healing adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2026.0,0.0583234,"There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups.
","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Citterio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS , Rome, Italy.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, The Comprehensive Transplant Center, The Ohio State University, Wexner Medical Center , Columbus, OH, USA.'}, {'ForeName': 'Dean Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Henry Ford Hospital , Detroit, USA.'}, {'ForeName': 'Myoung Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine , Seoul, Republic of Korea.'}, {'ForeName': 'Duck-Jong', 'Initials': 'DJ', 'LastName': 'Han', 'Affiliation': 'Asan Medical Center , Seoul, Republic of South Korea.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kenmochi', 'Affiliation': 'Department of Transplant Surgery, Fujita Health University , Toyoake, Aichi, Japan.'}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Mor', 'Affiliation': 'Director of Transplant Center at Sheba Medical Center , Ramat-Gan, Israel.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Department of Surgery HPB and Transplant Unit, University of Tor Vergata , Rome, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG , Basel, Switzerland.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Hernandez Gutierrez', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG , Basel, Switzerland.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Surgery and Nephrology, Nagoya Daini Red Cross Hospital , Nagoya-City, Aich, Japan.'}]",Expert opinion on drug safety,['10.1080/14740338.2020.1792441']
1915,32633196,Swallowing Patterns in the HNC Population: Timing of Penetration-Aspiration Events and Residue.,"OBJECTIVE


This study described swallowing patterns in a large head/neck cancer (HNC) cohort.
STUDY DESIGN


In a retrospective review of data from a randomized controlled trial, we studied timing of penetration events as they related to aspiration and oral/pharyngeal residue.
SETTING


Retrospective review of a multicenter randomized controlled trial.
SUBJECTS AND METHODS


In total, 168 patients who were >3 months postradiation received baseline modified barium swallow evaluations. Retrospective analyses of data from these exams were studied, including Penetration-Aspiration Scale (PAS) scores and timing of these events (before, during, or after the swallow), as well as percentage of oral and pharyngeal residue.
RESULTS


Aspiration occurred more frequently  after  than before or during the swallow ( P  < .05). There were significantly more events of  penetration  that led to aspiration after the swallow (n = 260) when compared to events before (n = 6) or after (n = 81) the swallow. There was more pharyngeal (16%-25%) than oral residue (5%-20%). Weak correlations were found between thin liquid, nectar-thick liquid, pudding residue, and PAS scores, with varying significance (pharyngeal residue/PAS  r s : .26*, .35*, .07*; oral residue/PAS  r s : .21*, .16, .3; * P  < .05).
CONCLUSION


The predominant pattern for this sample of postradiation patients with HNC with dysphagia was aspiration that occurred after the swallow, rather than before or during the swallow. The aspiration was directly caused by penetration events that occurred during the swallow, resulting in aspiration as the airway reopened. Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events. These results guide clinicians in targeting appropriate swallowing interventions.",2020,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","['swallowing patterns in a large head/neck cancer (HNC) cohort', 'Swallowing Patterns in the HNC Population', '168 patients who were >3 months postradiation received baseline modified barium swallow evaluations']",['oral residue/PAS'],"['pharyngeal residue', 'percentage of oral and pharyngeal residue', 'Penetration-Aspiration Scale (PAS) scores and timing of these events']","[{'cui': 'C0426602', 'cui_str': 'Swallowing pattern'}, {'cui': 'C2243051', 'cui_str': 'Large head'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0203065', 'cui_str': 'Barium swallow'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",168.0,0.0169387,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Pisegna', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Langmore', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Meyer', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pauloski', 'Affiliation': 'University of Wisconsin-Milwaukee, College of Health Sciences, Comm-unication Sciences and Disorders, Milwaukee, Wisconsin, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820933883']
1916,32633217,Effects of Time-of-Day Training Preference on Resistance-Exercise Performance.,"Purpose : The purpose of this study was to investigate how time-of-day training preference influences resistance-exercise performance.  Methods:  Resistance trained males ( n  = 12) were recruited for this study. In a crossover, counterbalanced design, participants completed two separate bench-press exercise trials at different times of day: (a) morning (AM; 8:00 hr) and (b) evening (PM; 16:00 hr). Participants answered a questionnaire on time-of-day training preference and completed a preferred (PREF) and nonpreferred (NON-PREF) time-of-day trial. For each trial, motivation was measured using a visual analog scale prior to exercise. Participants completed 2 sets × 2 repetitions at 75% 1-RM with maximum explosiveness separated by 5 min of rest. Mean barbell velocity was measured using a linear position transducer. Participants then completed 1 set × repetitions to failure (RTF) at 75% 1-RM. Rate of perceived exertion (RPE) was measured immediately following exercise.  Results:  Regardless of preference, velocity ( p  = .025; effect size (ES) = 0.43) was higher during the PM versus AM trial. However, there were no significant differences in velocity ( p  = .368; ES = 0.37) between PREF and NON-PREF time of day. There were no significant differences for repetitions between PREF and NON-PREF times ( p  = .902; ES = 0.03). Motivation was higher in the PREF time versus NON-PREF ( p  = .015; ES = 0.68). Furthermore, RPE was significantly lower during the PREF time of day ( p  = .048; 0.55).  Conclusions:  Despite higher barbell velocity collectively at PM times, time-of-training preference did not largely influence resistance-exercise performance, while motivation is higher and RPE is lower during preferred times.",2020,Motivation was higher in the PREF time versus NON-PREF ( p  = .015; ES = 0.68).,['Methods:  Resistance trained males ( n  = 12'],[],"['Resistance-Exercise Performance', 'repetitions between PREF and NON-PREF times', 'Mean barbell velocity', 'Motivation', 'Rate of perceived exertion (RPE', 'velocity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",12.0,0.0861194,Motivation was higher in the PREF time versus NON-PREF ( p  = .015; ES = 0.68).,"[{'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Blazer', 'Affiliation': 'Samford University.'}, {'ForeName': 'Cassidy L', 'Initials': 'CL', 'LastName': 'Jordan', 'Affiliation': 'Samford University.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Pederson', 'Affiliation': 'Samford University.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Rogers', 'Affiliation': 'Samford University.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Williams', 'Affiliation': 'Samford University.'}, {'ForeName': 'Mallory R', 'Initials': 'MR', 'LastName': 'Marshall', 'Affiliation': 'Samford University.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Ballmann', 'Affiliation': 'Samford University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1751032']
1917,32633242,Mydrane intracameral injection site can be an alternative to mydriatic drops instillation in cataract surgery.,"The aim of this study is to compare Mydrane (combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) and mydriatic drops (tropicamide 1% and phenylephrine 10%) used for cataract surgery in terms of efficacy in pupil dilation and impact on corneal endothelial cell density (CD) and central corneal thickness (CCT). Prospective study including 64 eyes of 64 patients that underwent phacoemulsification with intraocular lens implantation. Patients were randomized into two groups: Mydrane group received: tropicamide and phenylephrine one day preoperatively and Mydrane during the surgery. Reference group received: tropicamide and phenylephrine preoperatively. Pupil size was measured only in Mydrane group, in the same eye of the same patient one day preoperatively after mydriatic drops were given and during the surgery, after intracameral Mydrane injection. CD and CCT were evaluated one day preoperatively and one month postoperatively in all patients and compared between Mydrane and reference groups. The results show CCT and CD significantly decreased after surgery in both groups. There is no difference in this decrease between groups. In Mydrane group there was no difference in dilated pupil diameter between Mydrane and mydriatic drops. Gender, diabetes mellitus, POAG, alpha-1 blocker treatment failed to affect pupil dilation obtained with Mydrane. Cataract surgery affects CCT and CD regardless of which mydriatic protocol had been used. Pupil diameter was similar after drops instillation and after Mydrane injection in all patients from the Mydrane group.",2020,Pupil diameter was similar after drops instillation and after Mydrane injection in all patients from the Mydrane group.,"['cataract surgery', '64 eyes of 64 patients that underwent']","['phacoemulsification with intraocular lens implantation', 'mydriatic drops (tropicamide 1% and phenylephrine', 'phenylephrine', 'Mydrane', 'lidocaine', 'tropicamide and phenylephrine', 'Mydrane (combination of tropicamide']","['CCT and CD', 'Pupil size', 'CD and CCT', 'corneal endothelial cell density (CD) and central corneal thickness (CCT', 'Pupil diameter', 'dilated pupil diameter']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1268934', 'cui_str': 'Small incision phacoemulsification of cataract and insertion of intraocular lens'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}]",64.0,0.0371178,Pupil diameter was similar after drops instillation and after Mydrane injection in all patients from the Mydrane group.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nazim-Lipski', 'Affiliation': 'Jagiellonian University Medical College, Faculty of Medicine, Division of Ophthalmology, Cracow, Poland. gabriela.nazim@gmail.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bolsega-Pacud', 'Affiliation': 'Jagiellonian University Medical College, Faculty of Medicine, Division of Ophthalmology, Cracow, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kubicka-Trzaska', 'Affiliation': 'Jagiellonian University Medical College, Faculty of Medicine, Division of Ophthalmology, Cracow, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Markiewicz', 'Affiliation': 'Jagiellonian University Medical College, Faculty of Medicine, Division of Ophthalmology, Cracow, Poland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Romanowska-Dixon', 'Affiliation': 'Jagiellonian University Medical College, Faculty of Medicine, Division of Ophthalmology, Cracow, Poland.'}]",Journal of physiology and pharmacology : an official journal of the Polish Physiological Society,['10.26402/jpp.2020.2.08']
1918,32633648,Mildly Processed Natural Eggshell Membrane Alleviates Joint Pain Associated with Osteoarthritis of the Knee: A Randomized Double-Blind Placebo-Controlled Study.,"Poor joint health is a significant burden to society. Millions of people suffer from some form of joint-related disorder or disease, most often osteoarthritis (OA). It was hypothesized that chicken eggshell membrane (EM) is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such relieves pain and stiffness in joints commonly affected in arthritis. We tested this hypothesis in a double-blind, placebo-controlled EM intervention study. Of 150 male and female volunteers, 40-75 years of age and diagnosed with knee OA, 75 were randomly assigned to the EM intervention group and 75 to the placebo group. During 12 weeks, subjects received a daily capsule containing either 300 mg of EM or a placebo. The main primary dependent variable consisted of self-reported pain ratings on a Numerical Rating Scale Pain (NRS-P) 6 weeks after study start. As secondary dependent variables served NRS-P scores collected after 12 weeks, and Knee injury and self-reported Osteoarthritis Outcome Scores (Knee injury and Osteoarthritis Outcome Scores [KOOS]). NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment. This effect was significant for two of five KOOS category scores, that is, ""Pain"" and ""Daily Life"" functioning, aggregate pain, and functioning scores composed of complaint ratings for a wide variety of daily activities. These scores showed long-lasting improvement, and demonstrated that EM extract successfully reliefs knee OA pain and contributes to daily life functioning.",2020,"NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment.","['150 male and female volunteers, 40-75 years of age and diagnosed with knee OA', 'Joint Pain Associated with Osteoarthritis of the Knee']","['EM intervention', 'Placebo', 'daily capsule containing either 300\u2009mg of EM or a placebo', 'placebo']","['pain scores', 'Knee injury and self-reported Osteoarthritis Outcome Scores (Knee injury and Osteoarthritis Outcome Scores [KOOS', 'Pain"" and ""Daily Life"" functioning, aggregate pain, and functioning scores', 'knee OA pain and contributes to daily life functioning', 'self-reported pain ratings on a Numerical Rating Scale Pain', 'NRS-P scores']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0013702', 'cui_str': 'Eggshell'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.585007,"NRS-P scores decreased for both groups at approximately the same rate, but only EM relieved self-reported pain scores obtained with the KOOS questionnaire starting 1 week after initiation of treatment.","[{'ForeName': 'Jeroen Lucas', 'Initials': 'JL', 'LastName': 'Kiers', 'Affiliation': 'JLK Nutrition, Amersfoort, The Netherlands.'}, {'ForeName': 'Johannes Hendrikus Franciscus', 'Initials': 'JHF', 'LastName': 'Bult', 'Affiliation': 'Applegg, Amersfoort, The Netherlands.'}]",Journal of medicinal food,['10.1089/jmf.2020.0034']
1919,32633650,Viewing nature scenes reduces the pain of social ostracism.,"In a series of four studies ( N s = 245, 135, 155, 222), we explored the effects of viewing nature scenes on promoting recovery from ostracism. We first manipulated experiences of ostracism, then randomly assigned participants to view photos of either nature, urban scenes, or neutral objects. Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem. Moreover, when asked to look back and recall how they felt at the time of being ostracized, participants who viewed nature photos reported significantly higher levels of retrospective satisfaction of basic emotional needs than did participants in control conditions. An internal meta-analysis revealed an effect size of  d  = 0.58. These studies are the first, to our knowledge, to provide experimental evidence of how exposure to nature can alleviate the pain of social ostracism.",2020,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.",[],[],"['balance and self-esteem', 'pain of social ostracism', 'retrospective satisfaction of basic emotional needs', 'levels of state social pain']",[],[],"[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0343304,"Across all four studies, participants who viewed nature photos reported significantly lower levels of state social pain, along with significantly higher levels of affect balance and self-esteem.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences , Beijing, China.'}, {'ForeName': 'Lishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Education College, Shaoguan University , Shaoguan, China.'}, {'ForeName': 'Holli-Anne', 'Initials': 'HA', 'LastName': 'Passmore', 'Affiliation': 'Nature Connectedness Group, University of Derby , Derby, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, University of British Columbia , British Columbia, Canada.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Mental Health Education & Counseling Centre, Zhejiang Ocean University , Zhoushan, China.'}, {'ForeName': 'Huajian', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology Chinese Academy of Sciences , Beijing, China.'}]",The Journal of social psychology,['10.1080/00224545.2020.1784826']
1920,32633662,Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue.,"BACKGROUND


Fatigue is the most common symptom of MS and has no effective pharmacotherapy.
OBJECTIVE


To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue.
METHODS


In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for 7 days following the infusion. Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models.
RESULTS


In total, 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after 7 days (-0.10 point; 95% confidence interval (CI): -0.32, 0.12;  p  = 0.40). We observed a trend in reduced FSS scores at 1 week (-5.2 points; 95% CI: -10.4, 0.14;  p  = 0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (-13.5 point; 95% CI: -25.0, -1.98;  p  = 0.04).
CONCLUSIONS


Ketamine infusions were safe and well-tolerated. While no change in DFS after 7 days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer term fatigue severity in people with MS.",2020,Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion.,"['18 participants were enrolled; 67% participants received', 'multiple sclerosis-related fatigue', '18 subjects with multiple sclerosis (MS) and reported fatigue']","['midazolam', 'ketamine', 'Ketamine', 'placebo']","['change in Daily Fatigue Severity (DFS', 'DFS', 'reduced FSS scores', 'Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS', 'safe and well-tolerated', 'tolerability, safety, and efficacy', 'MFIS score']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}]",18.0,0.700381,Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion.,"[{'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA/Department of Epidemiology, Johns Hopkins University School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Aurash', 'Initials': 'A', 'LastName': 'Soroosh', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Balshi', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Maher', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kaplin', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bardia', 'Initials': 'B', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520936226']
1921,32633681,Short and Long-Term Effects of a Simple-Strength-Training Program on Injuries Among Elite U-19 Soccer Players.,"Purpose : The aim of this study was to examine the short and long-term effects of a simple strength training program on muscle injury prevention in soccer players.  Methods : Twenty-seven U-19 elite male soccer players participated in the study. The investigation was conducted over two consecutive and similar seasons (e.g., the same staff, players, weekly training schedule), the first being the control and the second the experimental season. The strength program was carried out 2 times per week, for 10 weeks, during part of the preseason and in-season. Injury incidence and absence days were compared between both seasons, according to the injury rate ratio (IRR), with 95% CI and the Z test.  Results : A lower number of total and hamstring injuries were recorded during the experimental (9 and 2, respectively) compared to the control (15 and 7, respectively) period. During the 10 weeks intervention period, the injury rate ratio (IRR) was lower in the experimental season than in the control season (IRR = 8.12; 95% CI: 1.00-66.03; effect size (ES) = 3.30, large). In addition, there was a decline in absence days per injury and in the number of absence days/1000 h (IRR = 2.44; 95% CI: 1.90-3.14; ES = 1.12) during the experimental season.  Conclusion : The results of this study suggest that this simple strength-training program could reduce the muscle injury incidence during its application period in young soccer players.",2020,"A lower number of total and hamstring injuries were recorded during the experimental (9 and 2, respectively) compared to the control (15 and 7, respectively) period.","['Twenty-seven U-19 elite male soccer players participated in the study', 'soccer players', 'young soccer players', 'Elite U-19 Soccer Players']","['simple strength training program', 'Simple-Strength-Training Program']","['number of total and hamstring injuries', 'muscle injury incidence', 'injury rate ratio (IRR']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0410256', 'cui_str': 'Injury of muscle'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}]",,0.0216503,"A lower number of total and hamstring injuries were recorded during the experimental (9 and 2, respectively) compared to the control (15 and 7, respectively) period.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Raya-González', 'Affiliation': 'Universidad Isabel I.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suarez-Arrones', 'Affiliation': 'Universidad Pablo De Olavide.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanchez-Sanchez', 'Affiliation': 'Pontifical University of Salamanca.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Universidad De Los Lagos.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': '""G. d´Annunzio"" University of Chieti-Pescara.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sáez De Villarreal', 'Affiliation': 'Universidad Pablo De Olavide.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1741498']
1922,32633801,Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.,"Importance


Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.
Objective


To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.
Design, Setting, and Participants


Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.
Interventions


Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.
Main Outcomes and Measures


The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.
Results


Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.
Conclusions and Relevance


Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.
Trial Registration


ISRCTN Identifier:16392920.",2020,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","['120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group', '310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial', 'care home residents', 'Care Home Residents', 'residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care', '310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018']","['Lactobacillus rhamnosus GG', 'Probiotic', 'Placebo', 'daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12', 'placebo']","['Antibiotic Administration', 'Participant diary data (daily data including study product use, antibiotic administration, and signs of infection', 'deaths', 'cumulative antibiotic administration days for all-cause infections', 'Hospitalizations']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0338046', 'cui_str': 'Residential home'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.418672,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Antony J', 'Initials': 'AJ', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shepherd', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}]",JAMA,['10.1001/jama.2020.8556']
1923,32628385,[Hypertrophy of palatine tonsils - possible treatment approaches].,"OBJECTIVE


To evaluate the effectiveness of different approaches to the treatment of patients with hypertrophy of the palatine tonsils (HPT).
MATERIAL AND METHODS


90 children with HPT of II-III degree and 20 healthy children (group 1) aged from 3 to 7 years were included in the study. Children with HPT were divided into three groups: group 2 - children who underwent tonsillotomy ( n =30), group 3 - children who underwent conservative treatment, including only topical use of Polyoxidonium ( n =30), group 4 - children who underwent complex treatment (tonsillotomy with subsequent local use of Polyoxidonium), (n=30). The severity of nasal breathing disturbances on a visual analogue scale, the average number of acute respiratory viral infections 6 months before and after treatment, the level of gene expression of antimicrobial peptides before and after treatment, the degree of hypertrophy of the palatine tonsils and spleen with an assessment of the echostructure and determination of the spleen mass coefficient using Ultrasound were evaluated in the study.
RESULTS


In children receiving only Polyoxidonium, there was a decrease in the severity of nasal breathing disorders, a decrease in the frequency of acute respiratory viral infections, an increase in the expression of antimicrobial peptide genes compared to the initial level of these indicators. Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
CONCLUSION


It is proved that the use of Polyoxidonium in the complex treatment of HPT is clinically effective and safe.",2020,"Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
","['90 children with HPT of II-III degree and 20 healthy children (group 1) aged from 3 to 7 years were included in the study', 'Children with HPT', 'children with', 'patients with hypertrophy of the palatine tonsils (HPT']","['tonsillotomy', 'conservative treatment, including only topical use of Polyoxidonium', 'complex treatment (tonsillotomy with subsequent local use of Polyoxidonium', 'Polyoxidonium', 'HPT']","['severity of nasal breathing disorders', 'severity of nasal breathing disturbances', 'average number of acute respiratory infections', 'frequency of acute respiratory viral infections', 'expression of antimicrobial peptide genes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0193930', 'cui_str': 'Incision of tonsil'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C2716079', 'cui_str': 'Polyoxidonium'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",90.0,0.0182445,"Comprehensive treatment of children with HPT (group 4) showed a significant decrease in the severity of nasal breathing disorders, a decrease in the average number of acute respiratory infections within 6 months, an increase in the expression of antimicrobial peptide genes compared to children who underwent only tonsillotomy (group 2) or only conservative therapy (group 3).
","[{'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Karpova', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Gankovskaya', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Vozgoment', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Ya S', 'Initials': 'YS', 'LastName': 'Avalyan', 'Affiliation': 'Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'I Yu', 'Initials': 'IY', 'LastName': 'Kulikova', 'Affiliation': 'Lomonosov Institute of Fine Chemical Technologies, Russian Technological University, Moscow, Russia.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Merkusheva', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Khasanova', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}]",Vestnik otorinolaringologii,['10.17116/otorino20208503157']
1924,32628509,Effects of Phonomotor Therapy and Semantic Feature Analysis on Discourse Production.,"Background Anomia treatments typically focus on single word retrieval, although the ultimate goal of treatment is to improve functional communication at the level of discourse in daily situations. Aims The focus of this study was to investigate the impact of two effective anomia treatments on discourse production as measured by a story retell task. Method and Procedure Fifty-seven people with aphasia were randomized to receive either a phoneme-based treatment, Phonomotor Therapy (PMT; 28 participants), or a lexical-semantic treatment, Semantic Feature Analysis (SFA; 29 participants). Groups were matched for age, aphasia severity, education, and years post onset. All received 56-60 hr of treatment in a massed treatment schedule. Therapy was delivered for a total of 8-10 hr/week over the course of 6-7 weeks. All participants completed testing 1 week prior to treatment (A1), immediately following treatment (A2), and again 3 months later (A3). Discourse was analyzed through the percentage of correct information units at each time point. Outcomes and Results Both groups showed nonsignificant improvements from pretreatment to immediately posttreatment. The PMT group showed significant improvement 3 months posttreatment, while the SFA group returned to near-baseline levels. Conclusion These results add to our understanding of the effects of both PMT and SFA. Future research should address understanding variability in discourse outcomes across studies and the effects of aphasia severity and individual participant and treatment factors on treatment outcomes for both of these approaches.",2020,"The PMT group showed significant improvement 3 months posttreatment, while the SFA group returned to near-baseline levels.",['Method and Procedure Fifty-seven people with aphasia'],"['Phonomotor Therapy and Semantic Feature Analysis', 'phoneme-based treatment, Phonomotor Therapy (PMT; 28 participants), or a lexical-semantic treatment, Semantic Feature Analysis']","['Discourse Production', 'discourse production']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0346817,"The PMT group showed significant improvement 3 months posttreatment, while the SFA group returned to near-baseline levels.","[{'ForeName': 'JoAnn P', 'Initials': 'JP', 'LastName': 'Silkes', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Fergadiotis', 'Affiliation': 'Speech and Hearing Sciences Department, Portland State University, OR.'}, {'ForeName': 'Kasey', 'Initials': 'K', 'LastName': 'Graue', 'Affiliation': 'Speech and Hearing Sciences Department, Portland State University, OR.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kendall', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00111']
1925,32628547,Correction to: Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial.,,2020,,['Acute Myocardial Infarction'],"['Morphine', 'Metoclopramide Coadministration']",[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]",[],,0.053671,,[],Circulation,['10.1161/CIR.0000000000000881']
1926,32628550,"Response by Jackson et al to Letter Regarding Article, ""Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF"".",,2020,,['Women Compared With Men With Heart Failure and Preserved Ejection Fraction'],['Sacubitril-Valsartan Versus Valsartan'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]",[],,0.0201523,,"[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Jackson', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (A.M.J., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (A.M.J., P.S.J., J.J.V.M.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (S.D.S.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (A.M.J., P.S.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047275']
1927,32628582,"Randomized, Parallel Group, Open-Label Bioequivalence Trial of Intramuscular Pegaspargase in Patients With Relapsed Acute Lymphoblastic Leukemia.","PURPOSE


Pegylated asparaginase is comparatively safer than native asparaginase in the management of acute lymphoblastic leukemia (ALL). However, the high price and nonavailability in low- and middle-income countries limits its use. In 2014, the first generic of pegaspargase (Hamsyl) was approved in India for use as a second-line treatment option for ALL. The aim of this study was to assess whether the generic pegaspargase (the test product) was bioequivalent with the reference product (Oncaspar).
PATIENTS AND METHODS


This study was an open-label, parallel-group, comparative pharmacokinetic study in pediatric patients with relapsed ALL receiving their first dose (1,000 IU/m 2 ) of pegaspargase administered intramuscularly. Patients were randomly assigned 1-to-1 to either the test or the reference product. The 2 formulations were considered equivalent if the 90% CIs for area under the plasma asparaginase activity-time curve (AUC 0-t ) geometric mean test-to-reference ratio was within 75% to 133%.
RESULTS


Twenty-nine patients (6-18 years of age) were enrolled in this study, of whom 24 completed the study criteria and were considered for safety analysis (5 patients were ineligible for the assessment). Three patients were excluded from analysis, because of presence of anti-asparaginase antibodies, leaving 21 patients who were considered for bioequivalence pharmacokinetics data. The point estimate of AUC 0-t  for the test-to-reference ratio was 95.05 (90% CI, 75.07% to 120.33%). Maximum plasma concentration, trough concentrations (day 14), half-life, volume of distribution, drug clearance, and changes in the asparagine and glutamine levels were not significantly different between products. Adverse events were comparable in both groups.
CONCLUSION


Generic and reference pegaspargase had equivalent pharmacokinetics with comparable safety. This could be a safe and cost-effective alternative for patients with ALL, especially in low- and middle-income countries.",2020,"Adverse events were comparable in both groups.
","['pediatric patients with relapsed ALL receiving their first dose (1,000 IU/m 2 ) of pegaspargase administered intramuscularly', 'Patients', 'Three patients were excluded from analysis, because of presence of anti-asparaginase antibodies, leaving 21 patients who were considered for bioequivalence pharmacokinetics data', 'acute lymphoblastic leukemia (ALL', 'Twenty-nine patients (6-18 years of age) were enrolled in this study, of whom 24 completed the study criteria and were considered for safety analysis (5 patients were ineligible for the assessment', 'With Relapsed Acute Lymphoblastic Leukemia', 'patients with ALL, especially in low- and middle-income countries']","['Pegylated asparaginase', 'Intramuscular Pegaspargase']","['Adverse events', 'Maximum plasma concentration, trough concentrations (day 14), half-life, volume of distribution, drug clearance, and changes in the asparagine and glutamine levels', 'plasma asparaginase activity-time curve (AUC 0-t ) geometric mean test-to-reference ratio']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C4085663', 'cui_str': 'Drug clearance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",3.0,0.0573042,"Adverse events were comparable in both groups.
","[{'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Nookala Krishnamurthy', 'Affiliation': 'Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Narula', 'Affiliation': 'Homi Bhabha National Institute, Anushakthi Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Khushboo', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Awase', 'Affiliation': 'Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Pandit', 'Affiliation': 'Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Raut', 'Affiliation': 'Gennova Biopharmaceuticals Ltd, Pune, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gennova Biopharmaceuticals Ltd, Pune, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Gota', 'Affiliation': 'Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Shripad Dinanath', 'Initials': 'SD', 'LastName': 'Banavali', 'Affiliation': 'Homi Bhabha National Institute, Anushakthi Nagar, Mumbai, Maharashtra, India.'}]",JCO global oncology,['10.1200/GO.20.00113']
1928,32628612,Process Evaluation of an eHealth Intervention (Food4toddlers) to Improve Toddlers' Diet: Randomized Controlled Trial.,"BACKGROUND


Parents seek trustworthy information online to promote healthy eating for their toddlers. Such information must be perceived as relevant and easy to implement and use.
OBJECTIVE


The objectives of this study were to conduct a process evaluation of the electronic health (eHealth) intervention (Food4toddlers) targeting food environment, parental feeding practices, and toddlers' diet and to examine possible differences in these areas according to education and family composition.
METHODS


A 2-armed randomized controlled trial, including 298 parent-toddler dyads from Norway, was conducted in 2017. In total, 148 parents in the intervention group received access to an intervention website for 6 months. Data on website usage were retrieved from the learning management platform used (NEO). Participants' satisfaction with the intervention was asked for in a postintervention questionnaire. Chi-square and t tests were used to examine differences in usage and satisfaction between education and family composition groups.
RESULTS


Most participants were mothers (144/148, 97.2%), lived in two-adult households (148/148, 100%), and were born in Norway (132/148, 89.1%). Mean parental age was 31.5 years (SD 4.2). More than 87.8% (129/147) had a university education degree and 56.5% (83/147) had over 4 years of university education. Most (128/148, 86.5%) intervention participants entered the website at least once (mean days of access 7.4 [SD 7.1]). Most parents reported the website as appropriate to the child's age (71/83, 86%) and self-explanatory (79/83, 95%) and appreciated the interface (52/83, 63%) and layout (46/83, 55%). In total, 61% (51/83) stated that they learned something new from the intervention. Parents with over 4 years of university education and in 1-child households used the intervention website more than those with 4 years or less of university education (8.4 vs 5.9 days in total, P=.04) and households with more than 1 child (8.3 vs 5.8 days in total, P=.04), respectively.
CONCLUSIONS


The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition. For eHealth interventions to be effective, intervention materials such as websites must be used by the target group. Our results highlight the need to include users from different groups when developing interventions.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN92980420; http://www.isrctn.com/ISRCTN92980420.",2020,"The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition.","['Mean parental age was 31.5 years (SD 4.2', 'More than 87.8% (129/147) had a university education degree and 56.5% (83/147) had over 4 years of university education', '298 parent-toddler dyads from Norway, was conducted in 2017']","[""electronic health (eHealth) intervention (Food4toddlers) targeting food environment, parental feeding practices, and toddlers' diet"", 'eHealth Intervention (Food4toddlers']",['university education'],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030543', 'cui_str': 'Parental Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0953093,"The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition.","[{'ForeName': 'Margrethe', 'Initials': 'M', 'LastName': 'Røed', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Frøydis Nordgård', 'Initials': 'FN', 'LastName': 'Vik', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Elisabet Rudjord', 'Initials': 'ER', 'LastName': 'Hillesund', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Van Lippevelde', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Anine Christine', 'Initials': 'AC', 'LastName': 'Medin', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Nina Cecilie', 'Initials': 'NC', 'LastName': 'Øverby', 'Affiliation': 'Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, Kristiansand, Norway.'}]",JMIR human factors,['10.2196/18171']
1929,32628620,Effect of the surgical exposure on the early postoperative period after total knee arthroplasty,"INTRODUCTION


Total knee arthroplasty has become one of the most successful and safest surgical procedures in orthopedic surgery. Of the many different types of surgical exposure, the most common, so-called medial parapatellar (MP) incision is the cut of the quadriceps tendon, which impairs extensor function. In contrast, subvastus (S) exposure, which spares the extensor apparatus, may promise better healing.
AIM


The purpose of our prospective observational study at the Orthopedic Clinic of Semmelweis University is to compare the effects of the MP and the S excision on the early postoperative period.
METHOD


The 60 patients enrolled were randomly assigned to two different groups according to the type of intervention. In the study, we measured the effects of the two different methods of surgical exposure on homogeneous patient groups in the early postoperative period based on international literature and the parameters we defined.
RESULTS


Visual analog scale (VAS) measured resting and active pain levels for the first 10 days, suggesting a more pronounced difference in active VAS values for the S group. In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group. Taking into account the results of the other days, it is in favour of preserving the integrity of the extensor apparatus for improved postoperative functionality. Patients' knee joint range of motion was also measured. On day 1, those in the S group were significantly larger. As the days progress, MP group members catch up with S group during their rehabilitation. Group S patients had an average of 1.944 days to extended leg elevation, which is nearly two days shorter compared to the MP group (p<0.0001).
CONCLUSIONS


After statistical analysis of data, subvastus exposure appears to be more beneficial in the rehabilitation of the early postoperative period. However, large-scale, multicentre observational studies are required to establish evidence. Orv Hetil. 2020; 161(29): 1208-1214.",2020,"In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group.","['Orthopedic Clinic of Semmelweis University', 'total knee arthroplasty', '2020; 161(29): 1208-1214', '60 patients enrolled']",['MP and the S excision'],"['Visual analog scale (VAS) measured resting and active pain levels', 'knee joint range of motion', 'active VAS values', 'pain']","[{'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0321759,"In the case of active VAS, patients in the S group also had significantly less pain on days 2, 3, and 10 than in the MP group.","[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bejek', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Holnapy', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Skaliczki', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Bence', 'Initials': 'B', 'LastName': 'Stubnya', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Szatmári', 'Affiliation': 'Általános Orvostudományi Kar, Ortopédiai Klinika,Semmelweis Egyetem, Budapest, Üllői út 78/b, 1082.'}]",Orvosi hetilap,['10.1556/650.2020.31774']
1930,32628771,Biopsy Outperforms Reflectance Confocal Microscopy in Diagnosing and Subtyping Basal Cell Carcinoma: Results and Experiences from a Randomized Controlled Multicentre Trial.,"BACKGROUND


Reflectance confocal microscopy (RCM) is a non-invasive method for skin assessment, allowing entire lesion evaluation up to the papillary dermis. Therefore, RCM is a potentially attractive alternative to punch biopsy in basal cell carcinoma (BCC).
OBJECTIVES AND DESIGN


This randomized controlled trial aimed to investigate RCM as alternative to punch biopsy in a real-world clinical setting. Primary objective was to determine the diagnostic accuracy of RCM compared to punch biopsy in diagnosing and subtyping BCC. Secondary objectives were to study related patient satisfaction and preferences.
METHODS


Patients with a clinically suspected primary BCC were randomized between RCM and biopsy. Conventional surgical excision or follow-up were used as reference. Sensitivity and specificity for BCC diagnosis and subtyping were calculated for both methods. BCC subtype was stratified based on clinical relevance: aggressive (infiltrative/micronodular) versus non-aggressive (superficial/nodular) histopathological subtype and superficial versus non-superficial BCC. Data on patient satisfaction and preferences werecollected using a questionnaire and a contingent valuation method.
RESULTS


Sensitivity for BCC diagnosis was high and similar for both methods (RCM 99.0% versus biopsy 99.0%, p=1.00). Specificity for BCC diagnosis was lower with RCM (59.1% versus 100.0%, p<0.001). Sensitivity for aggressive BCC subtypeswas lower for RCM (33.3% versus 77.3%, p=0.003). Sensitivity for non-superficial BCC was not significantly different (RCM 88.9% versus biopsy 91.0%, p=0.724). Patient satisfaction and preferences were good and highly comparable for both methods.
CONCLUSIONS


Biopsy outperforms RCM in diagnosing and subtyping clinically suspected primary BCC. This outcome does not support routine clinical implementation of RCM, as a replacement of punch biopsies in this patient group.",2020,"Specificity for BCC diagnosis was lower with RCM (59.1% versus 100.0%, p<0.001).",['Patients with a clinically suspected primary BCC'],"['RCM', 'Biopsy Outperforms Reflectance Confocal Microscopy', 'Reflectance confocal microscopy (RCM', 'Conventional surgical excision', 'RCM and biopsy']","['diagnostic accuracy of RCM', 'Sensitivity and specificity for BCC diagnosis and subtyping', 'patient satisfaction and preferences', 'Sensitivity for non-superficial BCC', 'Specificity for BCC diagnosis', 'Sensitivity for BCC diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}]","[{'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0862889', 'cui_str': 'Superficial basal cell carcinoma'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.112967,"Specificity for BCC diagnosis was lower with RCM (59.1% versus 100.0%, p<0.001).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Woliner-van der Weg', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peppelman', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Elshot', 'Affiliation': 'Department of Dermatology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Visch', 'Affiliation': 'Department of Dermatology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Crijns', 'Affiliation': 'Department of Dermatology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'H A C', 'Initials': 'HAC', 'LastName': 'Alkemade', 'Affiliation': 'Department of Dermatology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Adang', 'Affiliation': 'Department of Health Evidence, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amir', 'Affiliation': 'Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'M J P', 'Initials': 'MJP', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'P E J', 'Initials': 'PEJ', 'LastName': 'van Erp', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'S F K', 'Initials': 'SFK', 'LastName': 'Lubeek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.19381']
1931,32628781,The Systemic Inflammatory Response Following Hand Instrumentation vs Ultrasonic Instrumentation - A Randomised Controlled Trial.,"OBJECTIVE


This study sought to investigate whether the immediate systemic inflammatory response following full mouth debridement differs following use of hand compared with ultrasonic instruments.
METHODS


Thirty-nine periodontitis patients were randomised to treatment with full-mouth debridement using either hand or ultrasonic instrumentation completed within 24 hours. Serum and periodontal clinical parameters were collected at baseline, day 1, day 7 and day 90 post-treatment. Differences in systemic inflammatory markers were assessed using general linear models at each time-point, corrected for age, gender, smoking status, body mass index and baseline levels of each marker.
RESULTS


Across all patients, serum C-reactive protein increased at day 1, with no differences between hand and ultrasonic groups (p(adjusted)=0.22). There was no difference between groups in interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α (p(adjusted)=0.53) at day 1. Inflammatory markers returned to baseline levels by day 7. Treatment resulted in equal and marked improvements in clinical parameters in both groups; however, total treatment time was on average shorter for ultrasonic instruments (p(adjusted)=0.002).
CONCLUSIONS


Ultrasonic instrumentation resulted in shorter treatment time with comparable clinical outcomes. Levels of serum C-reactive protein at day 1 were similar following debridement with hand or ultrasonic instruments.",2020,There was no difference between groups in interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α,['Thirty-nine periodontitis patients'],['full-mouth debridement using either hand or ultrasonic instrumentation'],"['Serum and periodontal clinical parameters', 'Inflammatory markers', 'interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α', 'total treatment time', 'clinical parameters', 'serum C-reactive protein', 'Levels of serum C-reactive protein', 'Systemic Inflammatory Response', 'systemic inflammatory markers']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",39.0,0.23062,There was no difference between groups in interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Johnston', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paterson', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Krystyna M', 'Initials': 'KM', 'LastName': 'Piela', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Davison', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Goulding', 'Affiliation': 'Global Clinical Affairs, Dentsply Sirona, 1301 Smile Way, York, PA, 17404, United States.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ramage', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sherriff', 'Affiliation': 'Community Oral Health, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Culshaw', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}]",Journal of clinical periodontology,['10.1111/jcpe.13342']
1932,32629226,Occurrence of c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in DHCR7 gene in population of polish women with recurrent miscarriage.,"INTRODUCTION


Recurrent miscarriage is a serious clinical problem that affects 1-5 % of all couples trying to conceive. Although the incidence of Smith-Lemli-Opitz Syndrome (SLOS, OMIM #270400), an autosomal recessive condition caused by variants in the DHCR7 gene, is very low, (1:83 000), the observed carrier frequency of DHCR7 gene variants in the Polish population is high, ranging from 1:24 to 1:31. It is possible that this carriage may be responsible for early pregnancy loss.
OBJECTIVES


The aim of the study is to determine the carrier frequency of the p c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in the DHCR7 gene in patients experiencing recurrent miscarriage.
METHODS


The study group included 480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage. The variants were identified by genotyping: c.976 G>T (p.Val326Leu) by the TaqMan® SNP Genotyping Assay system, and c.452 G>A (p.Trp151Ter) using the BfaI restriction enzyme. Statistical analysis was performed using R software.
RESULTS


No examples of c.976 G>T (p.Val326Leu) were found in either group. c.452 G>A (p.Trp151Ter) was found in 22 participants from the study group and 4 from the control group; however, this difference was not significant (Chi2 test p = 0.61).
CONCLUSIONS


Being a carrier of the c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.",2020,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"['population of polish women with recurrent miscarriage', 'patients experiencing recurrent miscarriage', '480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage']","['Val326Leu) and c.452 G', 'G']",[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],[],,0.0226355,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Chrzanowska-Steglińska', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland. Electronic address: marta.chrzanowska85@interia.pl.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Moczulska', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland; Clinical Genetics Clinic, Central Clinical Hospital of the Medical University of Lodz, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Skoczylas', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Pietrusiński', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Antosik', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Jakiel', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kacprzak', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Borowiec', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sieroszewski', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.063']
1933,32629291,A randomised double-blind trial of cognitive training for the prevention of psychopathology in at-risk youth.,"BACKGROUND


The aim of this study was to evaluate the effectiveness of online cognitive training as a means of reducing psychopathology in at-risk youth.
METHODS


In a double-blind randomised controlled trial, 228 youths (mean age = 18.6, 74.6% female) were randomly allocated to either an intervention group (n = 114; online cognitive training focused on executive functioning) and a control group (n = 114; online cognitive training focused on other cognitive abilities). Participants were assessed online at baseline, post-training, 3-, 6- and 12-month follow-up. The primary outcome of the study was overall psychopathology as measured by the Strengths and Difficulties Questionnaire. Secondary outcomes were executive functioning ability (assessed using the n-back, trail-making and Stroop tasks), day-to-day functioning and risky drinking.
RESULTS


Mixed model intention-to-treat analyses indicated that psychopathology increased and day-to-day functioning decreased, regardless of intervention group. Those in the intervention group improved more than those in the control group in terms of the n-back task, but this was not statistically significant after adjusting for multiple comparisons. There were no statistically significant effects on risky drinking, or the trail-making and Stroop tasks.
CONCLUSION


This study failed to provide evidence for the efficacy of cognitive training as a stand-alone intervention for psychopathology.",2020,"Those in the intervention group improved more than those in the control group in terms of the n-back task, but this was not statistically significant after adjusting for multiple comparisons.","['psychopathology in at-risk youth', '228 youths (mean age\xa0=\xa018.6, 74.6% female']","['cognitive training', 'intervention group (n\xa0=\xa0114; online cognitive training focused on executive functioning) and a control group (n\xa0=\xa0114; online cognitive training focused on other cognitive abilities', 'online cognitive training']","['psychopathology increased and day-to-day functioning', 'executive functioning ability (assessed using the n-back, trail-making and Stroop tasks), day-to-day functioning and risky drinking', 'risky drinking, or the trail-making and Stroop tasks', 'overall psychopathology as measured by the Strengths and Difficulties Questionnaire']","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",228.0,0.191026,"Those in the intervention group improved more than those in the control group in terms of the n-back task, but this was not statistically significant after adjusting for multiple comparisons.","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mewton', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Sydney, Australia. Electronic address: louisem@unsw.edu.au.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Hodge', 'Affiliation': ""Child Development Unit, The Children's Hospital, Westmead, Australia.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gates', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Visontay', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103672']
1934,32629295,Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II).,"BACKGROUND


A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.
STUDY DESIGN AND OBJECTIVES


REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.
CONCLUSIONS


REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.",2019,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"['608 HF patients age', 'Patients with Heart Failure II', 'heart failure', 'patients with heart failure (HF) and left ventricular ejection fraction (LVEF', 'patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40']","['novel transcatheter InterAtrial Shunt Device (IASD', 'LVEF', 'supine ergometer exercise, and PCWP ≥5', 'Transcatheter InterAtrial Shunt Device', 'IASD']","['HF hospitalizations or healthcare facility visits', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'pulmonary capillary wedge pressure (PCWP', 'Elevated Left Atrial Pressure', 'hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428877', 'cui_str': 'Atrial pressure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C4544192', 'cui_str': 'Interatrial shunt'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",608.0,0.173581,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Berry', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'Corvia Medical, Tewksbury, MA.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Massaro', 'Affiliation': 'Boston University, Boston, MA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: sanjiv.shah@northwestern.edu.'}]",American heart journal,['10.1016/j.ahj.2019.10.015']
1935,32629336,"The effects of a virtual learning environment compared with an individual handheld device on pharmacology knowledge acquisition, satisfaction and comfort ratings.","BACKGROUND


Virtual reality is reported to improve post-intervention knowledge and skills outcomes of health professionals compared to traditional teaching methods or digital online media. However, providing equitable access to high quality virtual reality resources for large, diverse nursing and midwifery student cohorts within multi-campus settings remains challenging.
OBJECTIVES


This study compared the effect on student learning, satisfaction and comfort following exposure to a three-dimensional pharmacology artefact in a virtual facility (CAVE2™) 1  with viewing of the same artefact using a mobile handheld device with stereoscopic lenses attached.
DESIGN


The study used a pretest-posttest design.
SETTING


School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia.
PARTICIPANTS


Two hundred and forty-nine second year undergraduate nursing and midwifery students.
METHODS


Online multiple choice tests were deployed to measure knowledge acquisition. Self-reported satisfaction scores and comfort ratings were collected using questionnaires.
RESULTS


Participants were not disadvantaged in terms of knowledge acquisition by using either CAVE2™ or the mobile handheld visualisation mode (P = 0.977). Significant differences in favour of the CAVE2™ environment were found in between students' satisfaction scores for clinical reasoning (P = 0.013) and clinical learning (P < 0.001) compared to the handheld mode, and there were no significant differences in their satisfaction with debriefing and reflective practice processes (P = 0.377) related to undertaking visualisation activities. A small number of students using handheld devices with stereoscopic lenses reported greater discomfort in relation to the visualisation that negatively impacted their learning (P = 0.001).
CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.",2020,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","['Two hundred and forty-nine second year undergraduate nursing and midwifery students', 'School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia']","['virtual learning environment', 'stereoscopic lenses']","['Self-reported satisfaction scores and comfort ratings', 'satisfaction with debriefing and reflective practice processes', 'knowledge acquisition', 'satisfaction scores for clinical reasoning', 'clinical learning', 'pharmacology knowledge acquisition, satisfaction and comfort ratings']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]",,0.0701285,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: jhanson@usc.edu.au.'}, {'ForeName': 'Patrea', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: panders1@usc.edu.au.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Dunn', 'Affiliation': 'School Health and Sports Science, Locked Bag 4, Maroochydore DC 4558, Australia. Electronic address: pdunn2@usc.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104518']
1936,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1937,32629446,Phase III Randomized Study of Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy in Squamous Cell Carcinoma of Head and Neck: The INTERCEPTOR-GONO Study (NCT00999700).,"OBJECTIVES


Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study.
PATIENTS AND METHODS


Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed.
RESULTS


236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008).
CONCLUSION


The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.",2020,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"['236/282 patients were evaluable', 'Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible', 'Squamous Cell Carcinoma of Head and Neck']","['cisplatin/RT (CRT', 'cetuximab and RT (IBRT', 'IBRT and CRT', 'Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy', 'cetuximab-RT']","['body weight loss', 'efficacy, activity and toxicity', 'OS', 'Neutropenia and skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",,0.0219668,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"[{'ForeName': 'Marco Carlo', 'Initials': 'MC', 'LastName': 'Merlano', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy.'}, {'ForeName': 'Nerina', 'Initials': 'N', 'LastName': 'Denaro', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy, nerinadenaro@hotmail.com.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Vecchio', 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Curcio', 'Affiliation': 'Trials Office, Medical Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, San Paolo General Hospital, Savona, Italy.'}, {'ForeName': 'Almalina', 'Initials': 'A', 'LastName': 'Bagicalupo', 'Affiliation': 'Radiation Oncology, San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Gianmauro', 'Initials': 'G', 'LastName': 'Numico', 'Affiliation': 'Medical Oncology, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Elvio', 'Initials': 'E', 'LastName': 'Russi', 'Affiliation': 'Radiation Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': ""Corvo'"", 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Statistic Unit, Genova University, Genova, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oncology,['10.1159/000507733']
1938,32629535,"Radiofrequency thoracic sympathectomy for sympathetically maintained chronic post-mastectomy pain, a preliminary report: six months results.","AIM


Evaluation of the analgesic efficacy of radiofrequency thoracic sympathectomy for sympathetically maintained post-mastectomy pain syndrome (PMPS).
METHODS


Patients with PMPS, randomized to group TS, (n = 33) received radiofrequency thoracic sympathectomy or group SHAM, (n = 33). Post-operative pain treatment consisted of duloxetine, pregabalin, and tramadol for both groups. The outcome variables were the percentage of patients showed > 50% reduction of their VAS pain score, the pain intensity measured by VAS score, and the global perceived effect (GPE) evaluated during 6 months follow-up period.
RESULTS


A significant higher percentage of patients gained > 50% reduction of pain in TS group, (TS VS. SHAM) 25/30 (83.3%) vs. 18/31 (58%), P = 0.032, the percentage of patients gained > 50% reduction of their pain without analgesics was significantly higher in group TS, 10/25 (40%) vs. 0/18 (0%), P = 0.001, furthermore, the percentage of patients gained > 50% reduction of their pain treated with (tramadol +duloxetine+pregabalin) was significantly lower in group TS, 0/25 (0%) vs. 13/18 (75%), P = 0.001. VAS pain score was significantly lower in TS group at two weeks, (one, two, three, and six) months following the procedure. The GPE was significantly higher in group TS [median (IQR)], [7 (5:7) vs. 5 (4:6)] P < 0.001.
CONCLUSIONS


Radiofrequency thoracic sympathectomy for sympathetically maintained PMPS decreased VAS pain score, reduced the need to anti-neuropathic drugs, particularly opioid medications and provided a better patient's satisfaction.",2020,"the percentage of patients gained > 50% reduction of their pain without analgesics was significantly higher in group TS, 10/25 (40%) vs. 0/18 (0%),","['sympathetically maintained chronic post-mastectomy pain, a preliminary report', 'Patients with PMPS', 'sympathetically maintained post-mastectomy pain syndrome (PMPS']","['radiofrequency thoracic sympathectomy or group SHAM', 'tramadol +duloxetine+pregabalin', 'Radiofrequency thoracic sympathectomy', 'SHAM', 'duloxetine, pregabalin, and tramadol', 'radiofrequency thoracic sympathectomy']","['VAS pain score', 'pain', 'pain without analgesics', 'VAS pain score, the pain intensity measured by VAS score, and the global perceived effect (GPE']","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406845', 'cui_str': 'Post-mastectomy pain'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0607815,"the percentage of patients gained > 50% reduction of their pain without analgesics was significantly higher in group TS, 10/25 (40%) vs. 0/18 (0%),","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of anesthesia and pain management, South Egypt Cancer Institute, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Ashraf Amin', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of anesthesia and pain management, South Egypt Cancer Institute, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Essam Ezzat', 'Initials': 'EE', 'LastName': 'Abd El-Hakeem', 'Affiliation': 'Department of anesthesia and intensive care, Assuit university hospital, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Madona Misheal', 'Initials': 'MM', 'LastName': 'Boshra', 'Affiliation': 'Department of anesthesia and pain management, South Egypt Cancer Institute, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Moamen', 'Initials': 'MM', 'LastName': 'El-Barody', 'Affiliation': 'Department of radiodiagnosis, South Egypt Cancer Institute, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of anesthesia and pain management, South Egypt Cancer Institute, Assuit University, Assiut, Egypt.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12933']
1939,32629625,"Effectiveness of a primary care clinical ultrasound classroom for family physicians as a formative intervention system, a quasi-experimental trial: Study protocol.","INTRODUCTION


Clinical ultrasound is a technique that increases diagnostic capacity and facilitates clinical decision making. The objective is to develop and validate an ultrasound training methodology oriented to the clinical practice of the family physician.
METHODS


Quasi-experimental study, with a before/after design, a control group, and 1 year of follow-up. Twenty family physicians working in primary care health centers with a list of over 800 patients will be included, as well as a control group of family physicians with similar characteristics in terms of age, sex, and patient list. A structured training process oriented to the clinical practice of the family physician, primary care clinical ultrasound classroom (AECAP), will be carried out, and the improvement of knowledge and skills of the participants will be evaluated, as well as the improvement of the quality of care based on clinical indicators.
DISCUSSION


The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours. We hope that the results obtained in this study demonstrate the effectiveness of the structured training method (AECAP) and support the generalization of ultrasound in primary health care.
ETHICS AND DISSEMINATION


The study was approved by the Medical Research Ethics Committee of Salamanca on December 17, 2018 (cod 2018 11 134). The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number: NCT04283383.",2020,The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours.,"['Twenty family physicians working in primary care health centers with a list of over 800 patients will be included, as well as a control group of family physicians with similar characteristics in terms of age, sex, and patient list', 'Salamanca on December 17, 2018 (cod 2018 11 134']","['primary care clinical ultrasound classroom', 'primary care clinical ultrasound classroom (AECAP', 'structured training method (AECAP']",[],"[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],800.0,0.02116,The family physician is in a privileged situation allows increasing the performance of ultrasound in frequent clinical situations and reducing care hours.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diego-Domínguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Torrecilla-García', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Casado-Huerga', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'Maria Ángeles', 'Initials': 'MÁ', 'LastName': 'Paule-Sánchez', 'Affiliation': 'Centro de Salud de San Juan de Salamanca.'}, {'ForeName': 'Clara Isabel', 'Initials': 'CI', 'LastName': 'Soria-López', 'Affiliation': 'Centro de Salud de San Juan de Salamanca.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Iglesias-Clemente', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'de Dios-Hernández', 'Affiliation': 'Unidad Docente Multiprofesional de Atención Familiar y Comunitaria de Salamanca.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Diego-Mangas', 'Affiliation': 'Centro de Salud de Periurbana Norte, Servicio de Salud de Castilla y León, Salamanca, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Cubillo-Jiménez', 'Affiliation': 'Unidad Docente Multiprofesional de Atención Familiar y Comunitaria de Salamanca.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pérez-Escanilla', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL).'}]",Medicine,['10.1097/MD.0000000000019914']
1940,32629633,"Comparison of ventriculoperitoneal shunt to lumboperitoneal shunt in the treatment of posthemorrhagic hydrocephalus: A prospective, monocentric, non-randomized controlled trial.","BACKGROUND


Ventriculoperitoneal shunt (VPS) surgery remains the most widely accepted and used option method to treat post-hemorrhagic hydrocephalus (PHH) worldwide while lumboperitoneal shunt (LPS) serves as an effectively alternative treatment. However, the outcomes of VPS and LPS in the treatment of PHH have not been compared in a prospective trial.
METHODS AND DESIGN


In this monocentric, assessor-blinded, non-randomized controlled trial, 75 eligible patients with PHH for each group will be recruited to compare the outcomes of VPS cohort with that of LPS cohort. Each participant is evaluated before surgery, at the time of discharge, 3, and 6 months after surgery by experienced and practiced assessors. The primary outcome is the rate of shunt failure 6 months after shunt surgery. The secondary measure of efficacy is National Institute of Health stroke scale, together along with Glasgow coma scale, modified Rankin Scale, and Evans index at the evaluation point. A favorable outcome is defined as shunt success with an improvement of more than 1 point in the National Institute of Health stroke scale. Complication events occurring within 6 months after surgery are investigated. A serious adverse events throughout the study are recorded regarding the safety of shunts.
DISCUSSION


The results of this trial will provide evidence for the treatment options for patients with PHH.",2020,"A serious adverse events throughout the study are recorded regarding the safety of shunts.
","['75 eligible patients with PHH for each group will be recruited to compare the outcomes of VPS cohort with that of LPS cohort', 'patients with PHH', 'posthemorrhagic hydrocephalus']","['ventriculoperitoneal shunt to lumboperitoneal shunt', 'Ventriculoperitoneal shunt (VPS) surgery']","['efficacy is National Institute of Health stroke scale, together along with Glasgow coma scale, modified Rankin Scale, and Evans index', 'Complication events', 'rate of shunt failure 6 months after shunt surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephalus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162702', 'cui_str': 'Ventriculoperitoneal shunt'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C1299564', 'cui_str': 'Posthemorrhagic hydrocephalus'}]","[{'cui': 'C0162702', 'cui_str': 'Ventriculoperitoneal shunt'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.137353,"A serious adverse events throughout the study are recorded regarding the safety of shunts.
","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'You', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yikai', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery.'}]",Medicine,['10.1097/MD.0000000000020528']
1941,32629639,Personalized trimodal prehabilitation for gastrectomy.,"BACKGROUND


Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer.
METHODS


PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board.
DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).",2020,"DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer.","['patients undergoing major abdominal surgery', 'patients undergoing gastrectomy for gastric cancer', 'gastric cancer between patients with or without prehabilitation', 'One-hundred twenty-eight patients']","['trimodal home-based prehabilitation including nutritional, psychological and exercise interventions']","['physical fitness and activity levels, nutritional status and quality of life', 'physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board', 'anxiety and depression levels', 'postoperative morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",128.0,0.0360009,"DISCUSSION


PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer.","[{'ForeName': 'Augustinas', 'Initials': 'A', 'LastName': 'Bausys', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Martynas', 'Initials': 'M', 'LastName': 'Luksta', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Justas', 'Initials': 'J', 'LastName': 'Kuliavas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Giedre', 'Initials': 'G', 'LastName': 'Anglickiene', 'Affiliation': 'Department of Medical Oncology, National Cancer Institute.'}, {'ForeName': 'Vyte', 'Initials': 'V', 'LastName': 'Maneikiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Gedvilaite', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Celutkiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine of the Faculty of Medicine.'}, {'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Jamontaite', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Cirtautas', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Lenickiene', 'Affiliation': 'Department of Rehabilitation, Physical and Sports Medicine, Institute of Health Sciences, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Vaitkeviciute', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Gaveliene', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Gertruda', 'Initials': 'G', 'LastName': 'Klimaviciute', 'Affiliation': 'National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'Rimantas', 'Initials': 'R', 'LastName': 'Bausys', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Strupas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.'}]",Medicine,['10.1097/MD.0000000000020687']
1942,32629640,All-inside versus inside-out suture techniques in arthroscopic meniscus repair: A prospective randomized study protocol.,"BACKGROUND


With advancements in our understanding of meniscal function, treatment options for meniscal injuries have evolved considerably over the past few decades. The aim of the current study was to compare the all-inside and inside-out techniques with regard to retear rate, functional outcomes, and perioperative complications in patients who had undergone arthroscopic meniscus repair. We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
METHODS


This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. This study was approved by the Institutional Review Board in our hospital and written informed consent was obtained from all subjects participating in the trial. It was carried out in accordance with the principles of the Helsinki Declaration. A total of 70 patients who meet inclusion criteria are randomized to either all-inside or inside-out group. The primary outcome measure was retear rate. Retear was determined by repeat arthroscopic evaluation of patients with follow-up for symptoms of persistent or new pain, catching, or locking that was possibly related to the meniscal repair. Secondary outcomes included disease-specific quality of life measurement with the Western Ontario Meniscal Evaluation Tool, range of motion, operative time, and adverse events at surgery or throughout the follow-up period.
RESULTS


This study has limited inclusion and exclusion criteria and a well-controlled intervention.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5589).",2020,"We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
","['patients who had undergone arthroscopic meniscus repair', 'subjects participating in the trial', 'arthroscopic meniscus repair', '70 patients who meet inclusion criteria']",['All-inside versus inside-out suture techniques'],"['disease-specific quality of life measurement with the Western Ontario Meniscal Evaluation Tool, range of motion, operative time, and adverse events at surgery or throughout the follow-up period', 'retear rate', 'postoperative outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.0844305,"We hypothesized that there was no significant difference between the 2 groups in terms of postoperative outcomes after arthroscopic meniscus repair.
","[{'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan 610072, China.'}, {'ForeName': 'Jiasong', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020688']
1943,32629657,Therapeutic effect of percutaneous vertebroplasty and nonoperative treatment on osteoporotic vertebral compression fracture: A randomized controlled trial protocol.,"BACKGROUND


Osteoporosis and related complications have been increasing with the aging population. Osteoporotic vertebral compression fractures (OVCFs) are the most common among all osteoporotic fractures. The purpose of this study was performed to compare the efficiency and safety of vertebroplasty versus conservative treatment for acute OVCFs.
METHODS


The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Written informed consent was obtained from every participant. Participants were randomly assigned (1:1) to receive either vertebroplasty or control group. The primary outcome was pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score. The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
RESULTS


We hypothesize that vertebroplasty will provide a rapid decrease of pain and an early return to daily life activities compared with the control group.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5624).",2020,"The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
",['osteoporotic vertebral compression fracture'],"['percutaneous vertebroplasty and nonoperative treatment', 'vertebroplasty or control group', 'vertebroplasty']","['Osteoporotic vertebral compression fractures (OVCFs', 'efficiency and safety', 'pain and an early return to daily life activities', 'Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications', 'pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.164349,"The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
","[{'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Spinal Surgery, Yancheng NO.1 People's Hospital, Jiang Su, China.""}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Cang', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020770']
1944,32629662,Exploratory study on the safety and effectiveness of Yizhi Qingxin Decoction (capsules) in the treatment of hypertension in the elderly with mild cognitive impairment (deficiency of kidney essence syndrome).,"BACKGROUND


Hypertension in the elderly with cognitive impairment has been one of the global health issues. Mild cognitive impairment (MCI) is the state of transition between the normal aging process and cognitive changes of unformed dementia. Diagnosis and treatment of MCI are the keys to prevent dementia, and hypertension is one of the important influencing factors of MCI. Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role. The objective is to estimate the safety and efficacy of YQD (capsules) in the treatment of hypertension in the elderly with MCI (deficiency of kidney essence syndrome) through this study.
METHODS


According to the random number generated by the block random method, 100 participants will be randomly and equally divided into the treatment group (YQD) or the control group (Ginkgo biloba extract tablets). The conversion rate of dementia will be used as the main evaluating indicator by the CDR scale. The MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure will be used as the secondary evaluating indicator. Safety will be evaluated based on specific manifestations of adverse reactions and the incidence of adverse events.
OBJECTIVE


The objective is to estimate the curative effect of YQD (capsules) on hypertension in the elderly with MCI (deficiency of kidney essence syndrome), and to evaluate the safety of its clinical application.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ICTRP member): ChiCTR2000030292.",2020,"Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role.","['hypertension in the elderly with mild cognitive impairment (deficiency of kidney essence syndrome', 'hypertension in the elderly with MCI (deficiency of kidney essence syndrome', 'elderly with cognitive impairment', 'spontaneously hypertensive rats (SHR', 'elderly with MCI (deficiency of kidney essence syndrome']","['Yizhi Qingxin Decoction (YQD', 'Yizhi Qingxin Decoction (capsules', 'YQD (capsules', 'control group (Ginkgo biloba extract tablets', 'MCI']","['safety and effectiveness', 'Mild cognitive impairment (MCI', 'blood pressure', 'MoCA scale, MMSE scale, ADCS-MCI-ADL-24 scale, CGIC-KDS scale, and 24-h ambulatory blood pressure']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034705', 'cui_str': 'Spontaneously hypertensive rat'}]","[{'cui': 'C1869287', 'cui_str': 'yi-zhi'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}]",100.0,0.0229678,"Our preclinical experiment found that Yizhi Qingxin Decoction (YQD) could effectively reduce the blood pressure of spontaneously hypertensive rats (SHR), improve their spatial learning and memory abilities in Morris water maze, and play a neuroprotective role.","[{'ForeName': 'Bi-Qing', 'Initials': 'BQ', 'LastName': 'Wang', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Chun-Xiao', 'Initials': 'CX', 'LastName': 'Ju', 'Affiliation': 'Clinical College, Beijing University of Chinese Medicine.'}, {'ForeName': 'Jun-Nan', 'Initials': 'JN', 'LastName': 'Zhao', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Feng-Qin', 'Initials': 'FQ', 'LastName': 'Xu', 'Affiliation': 'Institute of Geriatrics.'}, {'ForeName': 'Ke-Ji', 'Initials': 'KJ', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000020789']
1945,32629668,"Efficacy and safety of low-dose glucocorticoids combined with methotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: A single-center, randomized, double-blind clinical trial.","INTRODUCTION


Glucocorticoids (GCs), especially low-dose GCs, are commonly prescribed for rheumatoid arthritis (RA), although the risk/benefit ratio is controversial. A randomized, double-blind clinical trial was performed to evaluate the efficacy and safety of low-dose oral GCs combined with methotrexate (MTX) and hydroxychloroquine (HCQ) in early RA (ERA).
METHODS


Eighty untreated ERA patients were randomized into the trial (GCs + MTX + HCQ) and control (placebo + MTX + HCQ) groups, for 1-year treatment. Therapeutic evaluation indices were American College of Rheumatology (ACR) 20 of ACR, disease activity score (DAS) 28- erythrocyte sedimentation rate (ESR), visual analog scale scores, joint function, health assessment questionnaire-disability index score, morning stiffness duration, C-reaction protein and ESR. The clinical indicators were evaluated pre-treatment and at 1st, 3th, 6th and 12th month of treatment. The MRI data of single joint (ie, the most swollen joint) for each patient were acquired with a revised OMERACT RAMRIS Scoring System before and after treatment. The correlation analysis was adopted to confirm whether the efficacy of GC treatment is related to the time of RA onset. The side effects (eg, gastrointestinal reactions, liver dysfunction, upper respiratory tract infection, leukocyte reduction) were also monitored.
RESULTS


At 1st month, 55% and 20% cases in the experimental and control groups achieved ACR20 response, respectively, indicating a significant difference (χ = 16.157, P < .001). This trend continued until 6th month. At 12th month, the number of patients achieved ACR20 response was similar in both groups. At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05). The experimental group showed improved inflammation, quality of life and radiological symptoms. Bone erosion remained unchanged in the experimental group, while worsening in control group. Correlation coefficients between RA duration and DAS28-ESR score were 0.496, 0.464, 0.509, and 0.550 at 1st, 3th, 6th, and 12th month, respectively. No differences were found in adverse events between the 2 groups.
CONCLUSIONS


Low-dose GCs combined with MTX and HCQ significantly achieves disease remission indexed by ACR20 and DAS28-ESR, and improves clinical and radiological outcomes in ERA patients at the early stage, with superiority over placebo + MTX + HCQ, without enhancing adverse reactions.",2020,"At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05).","['Eighty untreated ERA patients', 'early rheumatoid arthritis']","['low-dose glucocorticoids combined with methotrexate and hydroxychloroquine', 'placebo + MTX + HCQ', 'MTX and HCQ', 'low-dose oral GCs combined with methotrexate (MTX) and hydroxychloroquine (HCQ', 'trial (GCs + MTX + HCQ) and control (placebo + MTX + HCQ', 'Glucocorticoids (GCs']","['American College of Rheumatology (ACR) 20 of ACR, disease activity score (DAS', 'side effects (eg, gastrointestinal reactions, liver dysfunction, upper respiratory tract infection, leukocyte reduction', 'Efficacy and safety', 'inflammation, quality of life and radiological symptoms', 'disease remission', '28- erythrocyte sedimentation rate (ESR), visual analog scale scores, joint function, health assessment questionnaire-disability index score, morning stiffness duration, C-reaction protein and ESR', 'efficacy and safety', 'DAS28- ESR scores', 'Bone erosion', 'adverse events', 'RA duration and DAS28-ESR score', 'ACR20 response', 'clinical and radiological outcomes']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.115868,"At 1st to 6th month, DAS28- ESR scores in the experimental group were significantly lower than control values (all p < .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Ying', 'Affiliation': 'Department of Radiology, Jinhua Municipal Central Hospital, Jinhua Zhejiang, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Rheumatology.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Rheumatology.'}]",Medicine,['10.1097/MD.0000000000020824']
1946,32629682,Enhanced recovery after surgery (ERAS) protocols in patients undergoing radical cystectomy with ileal urinary diversions: A randomized controlled trial.,"BACKGROUND


Enhanced Recovery After Surgery (ERAS) protocols were introduced in clinical practice to reduce complication rates and hospital stay. We performed a randomized controlled single center study to evaluate perioperative benefits of an adapted ERAS protocol in patients with bladder cancer who underwent radical cystectomy (RC) and ileal urinary diversions (IUD).
MATERIALS AND METHODS


Forty five from 90 consecutive randomized patients were enrolled in an adapted ERAS protocol. Length of stay, diet issues, return of bowel function, readmission rates and complications were examined.
RESULTS


Among patients following ERAS protocol, we found a significant reduction in time to first flatus (1 vs 5 days, P < .001), time to first stool (2 vs 5 days, P < .001), time to normal diet (5 vs 6 days, P < .001) and length of stay (16 vs 18 days, P < .001). Also, postoperative ileus at less than 4 days was lower than in non-ERAS patients (15.6% vs 24.4%), but with a marginal trend toward significance (P = .05). Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance. We also found a lower readmission and complication rate in patients with ERAS protocol (6.6% vs 11.1%, P = .23 and 46.6% vs 57.5%, P = .29, respectively).
CONCLUSIONS


Implementation of ERAS protocol for patients undergoing RC in our center was associated with a significant reduction in the time to the first flatus, time to the first stool, time to a normal diet, length of hospital stay.",2020,"Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance.","['Forty five from 90 consecutive randomized patients were enrolled in an adapted ERAS protocol', 'patients undergoing radical cystectomy with ileal urinary diversions', 'patients with bladder cancer who underwent radical cystectomy (RC) and ileal urinary diversions (IUD']","['surgery (ERAS) protocols', 'adapted ERAS protocol']","['time to first flatus', 'time to first stool', 'lower readmission and complication rate', 'postoperative ileus', 'length of stay', 'Readmission rate', 'Length of stay, diet issues, return of bowel function, readmission rates and complications', 'time to normal diet', 'complication rates and hospital stay']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",90.0,0.0619973,"Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance.","[{'ForeName': 'Olaru', 'Initials': 'O', 'LastName': 'Vlad', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Baston', 'Initials': 'B', 'LastName': 'Catalin', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Harza', 'Initials': 'H', 'LastName': 'Mihai', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Preda', 'Initials': 'P', 'LastName': 'Adrian', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Olaru', 'Initials': 'O', 'LastName': 'Manuela', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gener', 'Affiliation': 'University of Medicine and Pharmacy ""Carol Davila"" Bucharest.'}, {'ForeName': 'Sinescu', 'Initials': 'S', 'LastName': 'Ioanel', 'Affiliation': 'Fundeni Clinical Institute, Center of Uronephrology and Renal Transplant.'}]",Medicine,['10.1097/MD.0000000000020902']
1947,32629685,The efficacy of acupuncture for the treatment and the fertility improvement in child-bearing period female with Hashimoto Disease: A randomized controlled study.,"BACKGROUND


Hashimoto thyroiditis (HT) is highly prevalent among reproductive-aged women and has a substantial negative impact on fertility. Currently, there is no specific treatment for Hashimoto thyroiditis. We hypothesize that acupuncture can halt or delay the progression of HT and improve fertility in child-bearing period female. We therefore designed a randomized controlled trial to test this hypothesis by comparing the therapeutic effect of acupuncture vs sham acupuncture in patients with Hashimoto thyroiditis.
METHODS


In this randomized controlled study, a total of 284 eligible patients will be assigned to acupuncture group (n = 142) or sham acupuncture group (n = 142) in a 1:1 ratio. All patients will receive 36 sessions in total for 12 consecutive weeks with the same acupoint prescription (RN23, ST9, RN17, RN4, RN6, ST36, SP6, KI6). The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb). Secondary outcomes include the thyroid function, ovarian function, the rate of primary ovarian insufficiency, and pregnancy outcome. The thyroid function and thyroid antibodies tests will be measured at weeks 0, 4, 8, and 12 after randomization. The ovarian function will be examined on the 2nd to 4th day of the menstrual period in the 1st month, 2nd month and 3rd month compared with baseline. Both the pregnancy outcome and the rate of primary ovarian insufficiency will be evaluated 1 year after treatment.
DISCUSSION


This will be the first large-scale trial specifically evaluating acupuncture therapy in child-bearing period female with Hashimoto thyroiditis. If the study confirms the effectiveness of acupuncture treatment, more consistent acupuncture therapy can be set up for clinical practice.
TRIAL REGISTRATION


Chinese Clinical Trials Register identifier, ChiCTR2000031320, registered on 27 March 2020.",2020,The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb).,"['reproductive-aged women', 'child-bearing period female with Hashimoto thyroiditis', 'patients with Hashimoto thyroiditis', 'child-bearing period female with Hashimoto Disease', '284 eligible patients', 'group (n\u200a=\u200a142) or']","['acupuncture', 'acupuncture vs sham acupuncture', 'Hashimoto thyroiditis (HT', 'acupuncture therapy', 'sham acupuncture']","['fertility improvement', 'thyroid function, ovarian function, the rate of primary ovarian insufficiency, and pregnancy outcome', 'thyroid function and thyroid antibodies tests', 'rate of primary ovarian insufficiency', 'titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb', 'ovarian function']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0677607', 'cui_str': 'Hashimoto thyroiditis'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0700384', 'cui_str': 'Thyroid antibody'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}]",284.0,0.195251,The primary assessment is the titers of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibody (TGAb).,"[{'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': 'College of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Ling', 'Affiliation': 'Maternal and Child Reproductive Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Juan', 'Affiliation': 'Maternal and Child Reproductive Hospital affiliated to Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, PR China.'}]",Medicine,['10.1097/MD.0000000000020909']
1948,32629698,Exercise-induced hypertension is associated with angiotensin II activity and total nitric oxide.,"Angiotensin II mediates exercise-induced hypertension (EIH), which adversely impacts future cardiovascular health. There is paucity of data on the association between EIH and angiotensin II in well-trained middle-aged marathoners. Therefore, we investigated the renin-angiotensin-aldosterone-system and total nitric oxide activity in middle-aged marathoners with EIH.Seventy middle-aged marathoners were divided into 3 groups: normal blood pressure ([NBPG] [n = 21]), EIH group ([EIHG] [n = 35]), and complex hypertension group ([CHG] [n = 14]). We defined NBPG as resting systolic BP/diastolic BP (SBP/DBP) of ≤140/90 mm Hg and maximal exercise SBP of ≤210 mm Hg, EIHG as resting SBP/DBP ≤140/90 mm Hg and maximal exercise SBP of ≥210 mm Hg, and CHG as resting SBP/DBP ≥140/90 mm Hg and maximal exercise SBP of ≥210 mm Hg. Renin-angiotensin-aldosterone-system and NO levels were measured before and 30 minutes after the graded exercise test.Renin level was elevated while angiotensin level was reduced after 30 minutes of graded exercise test. There was no change in angiotensin I and angiotensin converting enzyme levels. Comparing the groups, renin level was only elevated in the CHG during recovery, while aldosterone level was higher than the baseline level in the recovery phase in all groups. Angiotensin I level remained unchanged in all groups. Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups. NO level was unchanged in the NBPG group but reduced in the EIHG and CHG groups after exercise. At 3 minutes of recovery, SBP was the highest in the NBPG group, followed by the EIHG and CHG groups (P < .05).In conclusion, angiotensin II activity and reduced NO level are associated with EIH in middle-aged long-distance runners. Angiotensin II inhibitors may; therefore, be the more appropriate antihypertensive medication for runners with EIH.",2020,Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups.,"['middle-aged marathoners with EIH.Seventy middle-aged marathoners', 'runners with EIH', 'middle-aged long-distance runners']","['normal blood pressure ([NBPG] [n\u200a=\u200a21]), EIH group ([EIHG] [n\u200a=\u200a35]), and complex hypertension group ([CHG', 'renin-angiotensin-aldosterone-system and total nitric oxide activity', 'NBPG', 'Angiotensin II mediates exercise-induced hypertension (EIH']","['angiotensin level', 'Renin-angiotensin-aldosterone-system and NO levels', 'Renin level', 'Angiotensin II level', 'aldosterone level', 'Angiotensin I level', 'angiotensin II activity and reduced NO level', 'NO level', 'resting systolic BP/diastolic BP (SBP/DBP', 'angiotensin I and angiotensin converting enzyme levels', 'renin level']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]",,0.0210193,Angiotensin II level reduced significantly in the NBPG group but remained at the baseline in the EIHG and CHG groups.,"[{'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Medicine, Soonchunhyang University, Asan.'}, {'ForeName': 'Yongbum', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Sanggye Paik Hospital, Inje University College of Medicine.'}, {'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Chun', 'Affiliation': ""Department of Global Medical Science, Soojung Campus, Sungshin Women's University, Seoul, Republic of Korea.""}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""Department of Exercise Rehabilitation Welfare, Soojung Campus, Sungshin Women's University, Seoul, Republic of Korea.""}]",Medicine,['10.1097/MD.0000000000020943']
1949,32629706,The evaluation of a nurse-led hypertension management model in an urban community healthcare: A randomized controlled trial.,"BACKGROUND


Hypertension is a silent disease of the masses with an increasing prevalence and poor control rates. This study aims to establish and test the efficacy of a nurse-led hypertension management model in the community.
METHODS


A single-blind, randomized controlled trial was performed. 156 hypertensive patients with uncontrolled blood pressure were equally and randomly allocated into 2 groups. Patients in the study group received a 12-week period of hypertension management. Blood pressure, self-care behaviors, self-efficacy, and satisfaction were assessed at the start of recruitment, 12 and 16 weeks thereafter.
RESULTS


After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
CONCLUSIONS


The nurse-led hypertension management model is feasible and effective for patients with uncontrolled blood pressure in the community.",2020,"After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
","['156 hypertensive patients with uncontrolled blood pressure', 'patients with uncontrolled blood pressure in the community', 'urban community healthcare']","['nurse-led hypertension management model', 'hypertension management']","['Blood pressure, self-care behaviors, self-efficacy, and satisfaction', 'blood pressure', 'level of satisfaction with the hypertensive care', 'self-care behaviors']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]",156.0,0.035059,"After the intervention, blood pressure of patients in the study group had greater improvement in self-care behaviors and a higher level of satisfaction with the hypertensive care compared to the control group (both P < .05).
","[{'ForeName': 'Jian-Hong', 'Initials': 'JH', 'LastName': 'Miao', 'Affiliation': ""Tangshan Worker's Hospital, Tangshan.""}, {'ForeName': 'Hai-Shan', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': 'TangShan FuYou BaoJianYuan.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'TangShan Chinese Medicine Hospital, Heibei, P.R. China.'}]",Medicine,['10.1097/MD.0000000000020967']
1950,32629737,Clinical research for whether the Traditional Chinese medicine could promote the resorption of lumbar disc herniation: a randomized controlled trial.,"Lumbar disc herniation (LDH) is a common, disabling musculoskeletal disorder. Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed. Previous studies have confirmed that some traditional Chinese medicine (TCM) therapies can promote resorption of the protrusion. However, high-quality research evidence is needed to support the effectiveness of the protocol.
OBJECTIVE


This clinical trial aims to establish whether TCM can promote the resorption of LDH and to assess the efficacy of such therapy for LDH, thereby evaluating its clinical effect.
METHODS


The present study design is for a single-center, 2-arm, open-label randomized controlled trial. A total of 150 eligible LDH patients will be randomly assigned to either a TCM treatment group or a control group in a 1:1 ratio. Patients in the TCM group will be administered a TCM decoction for 4 weeks. Patients in the conventional drug control group will be instructed to take a specific daily dose of celecoxib. The primary outcome measure is the change from baseline in the volume of the protrusion, as assessed using MR images. Secondary outcome measures include visual analog scale pain scores and Japanese Orthopaedic Association scores assessed at 3 and 6 months.
DISCUSSION


The design and methodological rigor of this trial will allow evaluation of the basic clinical efficacy and safety data for TCM in the treatment of patients with LDH. The trial will also assess whether TCM can promote the resorption of LDH. This research will therefore help provide a solid foundation for the clinical treatment of LDH and for future research in TCM therapy.
TRIAL REGISTRATION


ChiCTR1900022377.",2020,Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed.,"['150 eligible LDH patients', 'patients with LDH']","['TCM', 'TCM decoction', 'Traditional Chinese medicine', 'celecoxib', 'Magnetic resonance imaging', 'Lumbar disc herniation (LDH']","['visual analog scale pain scores and Japanese Orthopaedic Association scores assessed at 3 and 6 months', 'change from baseline in the volume of the protrusion, as assessed using MR images', 'resorption of lumbar disc herniation']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0410592', 'cui_str': 'Resorption of lumbar disc'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",150.0,0.203265,Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed.,"[{'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Chunchun', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Shanghai Traditional Chinese Medicine Hospital, PR China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Suzhou Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai.'}, {'ForeName': 'Dezhi', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai.'}]",Medicine,['10.1097/MD.0000000000021069']
1951,32629738,The analgesic efficiency of pregabalin for the treatment of postoperative pain in total hip arthroplasty: A randomized controlled study protocol.,"BACKGROUND


Only few studies have yet investigated whether perioperative administration of pregabalin can reduce the incidence of postoperative chronic neuropathic pain after total hip arthroplasty (THA). This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA.
METHODS


This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. The study was approved by the Institutional Review Board in Weifang People's Hospital and written informed consent was obtained from all subjects before enrolment. A total of 120 patients who meet inclusion criteria are randomized to either pregabalin or placebo group. The primary objective of the study was visual analog scale score. As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
RESULTS


The null hypothesis of this study was that pregabalin would reduce pain after THA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5669).",2020,"As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
","['after total hip arthroplasty (THA', '120 patients who meet inclusion criteria', 'total hip arthroplasty']","['pregabalin', 'placebo with pregabalin', 'pregabalin or placebo']","['postoperative chronic neuropathic pain', 'opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications', 'analgesic efficiency', 'visual analog scale score', 'pain']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.187717,"As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.
","[{'ForeName': 'Yuangui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Weifang People's Hospital, Shandong 261000, China.""}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Guimin', 'Initials': 'G', 'LastName': 'Dong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021071']
1952,32629757,The Effect of Vitamin D 3  Supplementation on Physical Capacity among Active College-Aged Males.,"Vitamin D 3  supplementation can affect strength and power; however, the effect on both aerobic and anaerobic performance remains unclear. Here, we investigate the effects of eight weeks of a high dose of vitamin D 3  supplementation and its impact on circulating 25-hydroxyvitamin D (25-OH-D 3 ) concentrations and selected indicators of physical capacity. Subjects ( n  = 28, age 21.1 ± 1.6) were divided into two groups: supplemented (SUP), which was given 6000 IU of vitamin D 3  daily for eight weeks; and placebo group (PLA). Serum 25-OH-D 3  concentrations were determined in pre- and post-intervention. Aerobic (VO 2max  test) and anaerobic (Wingate Anaerobic Test) capacity were determined before and after the supplementation. The mean baseline concentration of 25-OH-D 3  was recognized as deficient (20 ng/mL) and significantly increased over time in the supplemented group ( p  < 0.01, η 2  = 0.86), whilst it remained unchanged in the placebo group. Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group. The VO 2max  differences were also significant in the supplemented group ( p  < 0.05). In summary, the changes in aerobic and anaerobic capacity observed in this study were associated with a serum concentration of 25-OH-D 3 . Our data imply that vitamin D 3  supplementation with a dose of 6000 IU daily for eight weeks is sufficient to improve physical capacity and vitamin D 3  status.",2020,"Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group.","['Subjects ( n  = 28, age 21.1 ± 1.6', 'Active College-Aged Males']","['Vitamin D 3  supplementation', 'vitamin D 3  supplementation', 'Vitamin D 3  Supplementation', 'vitamin D 3  daily for eight weeks; and placebo', 'placebo']","['anaerobic power', 'aerobic and anaerobic capacity', 'Serum 25-OH-D 3  concentrations', 'maximal aerobic', 'Physical Capacity', 'circulating 25-hydroxyvitamin D (25-OH-D 3 ) concentrations and selected indicators of physical capacity', 'mean baseline concentration of 25-OH-D 3', 'Aerobic (VO 2max  test) and anaerobic (Wingate Anaerobic Test) capacity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0716502,"Moreover, the supplementation caused a significant improvement in maximal aerobic ( p  < 0.05, η 2  = 0.27) and anaerobic power ( p  < 0.01, η 2  = 0.51) whereas no changes were observed in PLA group.","[{'ForeName': 'Sylwester', 'Initials': 'S', 'LastName': 'Kujach', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Lyzwinski', 'Affiliation': 'Department of Sport and Physical Education, Medical University of Gdansk, M. Skłodowskiej-Curie 3a, 80-210 Gdansk, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Chroboczek', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bialowas', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Faculty of Health Sciences, Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, Debinki 1, 80-211 Gdansk, Poland.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Laskowski', 'Affiliation': 'Faculty of Physical Education, Department of Physiology, Gdansk University of Physical Education and Sport, Gorskiego 1, 80-336 Gdansk, Poland.'}]",Nutrients,['10.3390/nu12071936']
1953,32629906,"Wheat Sensitivity and Functional Dyspepsia: A Pilot, Double-Blind, Randomized, Placebo-Controlled Dietary Crossover Trial with Novel Challenge Protocol.","Introduction:  Functional dyspepsia (FD), characterised by symptoms of epigastric pain or early satiety and post prandial distress, has been associated with duodenal eosinophilia, raising the possibility that it is driven by an environmental allergen. Non-coeliac gluten or wheat sensitivity (NCG/WS) has also been associated with both dyspeptic symptoms and duodenal eosinophilia, suggesting an overlap between these two conditions. The aim of this study was to evaluate the role of wheat (specifically gluten and fructans) in symptom reduction in participants with FD in a pilot randomized double-blind, placebo controlled, dietary crossover trial.  Methods:  Patients with Rome III criteria FD were recruited from a single tertiary centre in Newcastle, Australia. All were individually counselled on a diet low in both gluten and fermentable oligo-, di-, mono-saccharides, and polyols (FODMAPs) by a clinical dietitian, which was followed for four weeks (elimination diet phase). Those who had a >30% response to the run-in diet, as measured by the Nepean Dyspepsia Index, were then re-challenged with 'muesli' bars containing either gluten, fructan, or placebo in randomised order. Those with symptoms which significantly reduced during the elimination diet, but reliably reappeared (a mean change in overall dyspeptic symptoms of >30%) with gluten or fructan re-challenge were deemed to have wheat induced FD.  Results:  Eleven participants were enrolled in the study (75% female, mean age 43 years). Of the initial cohort, nine participants completed the elimination diet phase of whom four qualified for the rechallenge phase. The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087). A specific food trigger could not be reliably demonstrated.  Conclusions:  Although a gluten-free, low-FODMAP diet led to a modest overall reduction in symptoms in this cohort of FD patients, a specific trigger could not be identified. The modified Salerno criteria for NCG/WS identification trialled in this dietary rechallenge protocol was fit-for-purpose. However, larger trials are required to determine whether particular components of wheat induce symptoms in functional dyspepsia.",2020,"The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087).","['participants with FD', 'Patients with Rome III criteria FD were recruited from a single tertiary centre in Newcastle, Australia', 'Eleven participants were enrolled in the study (75% female, mean age 43 years']","['placebo', 'wheat (specifically gluten and fructans', 'Placebo', 'wheat sensitivity (NCG/WS']","['symptoms of functional dyspepsia', 'Wheat Sensitivity and Functional Dyspepsia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027983', 'cui_str': 'Newcastle disease'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",11.0,0.379517,"The gluten-free, low FODMAP diet led to an overall (albeit non-significant) improvement in symptoms of functional dyspepsia in the diet elimination phase (mean NDI symptom score 71.2 vs. 47.1,  p  = 0.087).","[{'ForeName': 'Michael D E', 'Initials': 'MDE', 'LastName': 'Potter', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Kerith', 'Initials': 'K', 'LastName': 'Duncanson', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Walker', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Keely', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12071947']
1954,32629949,Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1 st  Year Results of the Feel4Diabetes-Study.,"The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016-2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents' lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast ( p =  0.034) and fruits ( p  = 0.029), while in Belgium and Finland they increased their water intake ( p =  0.024). These findings indicate that the first year of the Feel4Diabetes intervention resulted in the improvement of certain lifestyle behaviors in parents from high-risk families.",2020,"Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group.","['Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe', '2110 high-risk parents']",['school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors'],"['water intake', 'Greece and Spain increased their consumption of breakfast', 'daily consumption of sugary drinks', 'certain lifestyle behaviors', 'Lifestyle Changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",2110.0,0.0332343,"Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group.","[{'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Christina-Paulina', 'Initials': 'CP', 'LastName': 'Lambrinou', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mavrogianni', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, B-9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, 00300 Helsinki, Finland.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9010 Varna, Bulgaria.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Department of Diabetology, Clinical Center of Endocrinology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Department of Family and Occupational Medicine, University of Debrecen, 4032 Debrecen, Hungary.'}, {'ForeName': 'Vicky Van', 'Initials': 'VV', 'LastName': 'Stappen', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, B-9000 Gent, Belgium.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, 00300 Helsinki, Finland.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Instituto Investigacion Sanitaria Aragon (IISA), CIBERCV, 50009 Zaragoza, Spain.'}, {'ForeName': 'Luis Α', 'Initials': 'LΑ', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, NUtrition and Development Research Group, School of Health Science (EUCS), University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'First Department of Propaedeutic Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, Sport Science and Dietetics, University of Thessaly, 42132 Trikala, Greece.'}]",Nutrients,['10.3390/nu12071949']
1955,32629992,Effects of Dietary Fibres on Acute Indomethacin-Induced Intestinal Hyperpermeability in the Elderly: A Randomised Placebo Controlled Parallel Clinical Trial.,"The effect of dietary fibres on intestinal barrier function has not been well studied, especially in the elderly. We aimed to investigate the potential of the dietary fibres oat β-glucan and wheat arabinoxylan to strengthen the intestinal barrier function and counteract acute non-steroid anti-inflammatory drug (indomethacin)-induced hyperpermeability in the elderly. A general population of elderly subjects (≥65 years,  n  = 49) was randomised to a daily supplementation (12g/day) of oat β-glucan, arabinoxylan or placebo (maltodextrin) for six weeks. The primary outcome was change in acute indomethacin-induced intestinal permeability from baseline, assessed by an in vivo multi-sugar permeability test. Secondary outcomes were changes from baseline in: gut microbiota composition, systemic inflammatory status and self-reported health. Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.",2020,"Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.","['Elderly', 'A general population of elderly subjects (≥65 years,  n  = 49']","['dietary fibres oat β-glucan and wheat arabinoxylan', 'Placebo', 'dietary fibres', 'Dietary Fibres', 'oat β-glucan, arabinoxylan or placebo (maltodextrin', 'placebo']","['change in acute indomethacin-induced intestinal permeability from baseline, assessed by an in vivo multi-sugar permeability test', 'Intestinal Hyperpermeability', 'intestinal hyperpermeability in vivo or gut microbiota composition', 'changes from baseline in: gut microbiota composition, systemic inflammatory status and self-reported health']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.287326,"Despite a majority of the study population (85%) showing a habitual fibre intake below the recommendation, no significant effects on acute indomethacin-induced intestinal hyperpermeability in vivo or gut microbiota composition were observed after six weeks intervention with either dietary fibre, compared to placebo.","[{'ForeName': 'John-Peter', 'Initials': 'JP', 'LastName': 'Ganda Mall', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Fart', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Sabet', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Carl Mårten', 'Initials': 'CM', 'LastName': 'Lindqvist', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Nestestog', 'Affiliation': 'Genetic Analysis AS, Kabelgata 8, 0580 Oslo, Norway.'}, {'ForeName': 'Finn Terje', 'Initials': 'FT', 'LastName': 'Hegge', 'Affiliation': 'Genetic Analysis AS, Kabelgata 8, 0580 Oslo, Norway.'}, {'ForeName': 'Åsa V', 'Initials': 'ÅV', 'LastName': 'Keita', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, 581 85 Linköping, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brummer', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Schoultz', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Södra Grev Rosengatan 32, 703 62 Örebro, Sweden.'}]",Nutrients,['10.3390/nu12071954']
1956,32629994,Effects of Artificial Texture Insoles and Foot Arches on Improving Arch Collapse in Flat Feet.,"The arches of the foot play a vital role in cushioning the impact and pressure generated from ground reaction forces due to body weight. Owing to a lack of normal human arch structure, people diagnosed as having flat feet often have discomfort in the soles of their feet. The results may not only cause inappropriate foot pressure distribution on the sole but also further cause foot injuries. This study heavily relies on a homemade foot pressure sensing device equipped with textured insoles of different heights and artificial arches. This was to explore the extent to which the pressure distribution of the foot in people with flat feet could be improved. A further comparison was made of the effects of using the textured insoles with different heights on two different groups of people diagnosed with flat and normal feet respectively. Sixty-five undergraduate and postgraduate volunteers were invited to receive the ink footprint test for measuring their degrees of arch index. Nine of these 65 had 2 flat feet, 3 had a left flat foot, 5 had a right flat foot, and 48 had 2 normal feet. To ensure the same number of subjects in both the control and the experimental groups, 9 of the 48 subjects who had normal feet were randomly selected. In total, 26 subjects (Male: 25, Female: 1; Age: 22 ± 1 years; height: 173.6 ± 2.5 cm; body mass: 68.3 ± 5.4 kg; BMI: 22.6 ± 1.2) were invited to participate in this foot pressure sensing insoles study. The experimental results showed that the use of textured insoles designed with different heights could not effectively improve the plantar pressure distribution and body stability in subjects with flat feet. Conversely, the use of an artificial arch effectively improved the excessive peak in pressure and poor body stability, and alleviated the problem of plantar collapse for patients with flat feet, especially in the inner part of their hallux and forefoot.",2020,The experimental results showed that the use of textured insoles designed with different heights could not effectively improve the plantar pressure distribution and body stability in subjects with flat feet.,"['Flat Feet', 'people diagnosed with flat and normal feet respectively', 'In total, 26 subjects (Male: 25, Female: 1; Age: 22 ± 1 years; height: 173.6 ± 2.5 cm; body mass: 68.3 ± 5.4 kg; BMI: 22.6 ± 1.2) were invited to participate in this foot pressure sensing insoles study', 'Sixty-five undergraduate and postgraduate volunteers', '48 subjects who had normal feet', 'subjects with flat feet', 'Nine of these 65 had 2 flat feet, 3 had a left flat foot, 5 had a right flat foot, and 48 had 2 normal feet']",['Artificial Texture Insoles and Foot Arches'],"['plantar pressure distribution and body stability', 'excessive peak in pressure and poor body stability']","[{'cui': 'C0016202', 'cui_str': 'Flatfeet'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0576239', 'cui_str': 'Foot normal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",26.0,0.0206057,The experimental results showed that the use of textured insoles designed with different heights could not effectively improve the plantar pressure distribution and body stability in subjects with flat feet.,"[{'ForeName': 'Yao-Te', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': 'Information Management, National Yunlin University of Science and Technology, Yunlin 64002, Taiwan.'}, {'ForeName': 'Jong-Chen', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Information Management, National Yunlin University of Science and Technology, Yunlin 64002, Taiwan.'}, {'ForeName': 'Ying-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Plastic surgery, National Taiwan University Hospital Yunlin Branch, Yunlin 640203, Taiwan.'}]","Sensors (Basel, Switzerland)",['10.3390/s20133667']
1957,32629997,The UK Pregnancies Better Eating and Activity Trial (UPBEAT); Pregnancy Outcomes and Health Behaviours by Obesity Class.,"The effectiveness of antenatal intervention in women with increasing obesity is unknown. This study investigated whether there was a differential effect of antenatal intervention on diet, physical activity and pregnancy outcomes in women stratified by obesity class using data from the UK Pregnancies Better Eating and Activity Trial (UPBEAT) ( n  = 1555). The stratification was by World Health Organization classifications: Class I, II and III (30-34.9 kg/m 2 , 35-39.9 kg/m 2  and ≥40 kg/m 2 ). Using linear and logistic regression, adjusted for confounders, outcomes were assessed post-intervention (27 +0 -28 +6  weeks' gestation) and in late pregnancy (34 +0 -36 +0  weeks' gestation). Interactions between obesity class and the intervention were explored. Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class I, by -2.01 kg (95% CI -3.45 to -0.57,  p  = 0.006). Class I and II intervention women reported significantly lower dietary glycaemic load and saturated fat intake across their pregnancy. This differential effect of the intervention suggests antenatal interventions for women with obesity should stratify outcomes by obesity severity. This would inform evidence-based antenatal strategies for high-risk groups, including women with a BMI ≥ 40 kg/m 2 .",2020,"Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class","['women with obesity', 'women stratified by obesity class using data from the UK Pregnancies Better Eating and Activity Trial (UPBEAT) ( n  = 1555', 'women with increasing obesity is unknown']",['antenatal intervention'],"['gestational weight gain (GWG', 'diet, physical activity and pregnancy outcomes', 'dietary glycaemic load and saturated fat intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}]",,0.0574858,"Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Peacock', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}]",International journal of environmental research and public health,['10.3390/ijerph17134712']
1958,32630031,Influence of Dietary Supplementation for Hyperhomocysteinemia Treatments.,"Hyperhomocysteinemia is recognized as risk factor for cardiovascular and age-associated diseases. Folic acid supplementation efficiently lowers plasma homocysteine (Hcy) levels, but high intake may negatively affect health because of unnatural levels of unmetabolized folic acid in the systemic circulation. Oxoproline (Oxo) provides by glutamic acid production an increase of intracellular folic acid trapping. Aim of this study was to compare the efficacy of three supplementation protocols: (1) traditional therapy (5-methyl-tetrahydrofolate: 15 mg/day); (2) 5 mL/day of Oxo with 300 μg folic acid (oxifolic); (3) 5 mL/day of Oxo alone (magnesio+) in a 90 days randomized trial on thirty-two moderate hyperhomocysteinemic (18.6 ± 2.4 μmol.L -1 ) patients (age 48 ± 14 yrs). Thiols: cysteine (Cys), cysteinylglycine (Cys-Gly) and glutathione levels were assessed too. Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted. Otherwise glutathione concentration significantly increased after oxifolic ( p  < 0.01) and traditional ( p  < 0.05) supplementation. The integration of Oxo resulted an interesting alternative to traditional therapy because absence or minimal number of folates in the integrator eliminates any chance of excess that can constitute a long-term risk.",2020,Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted.,['L -1 ) patients (age 48 ± 14 yrs'],"['Oxo with 300 μg folic acid (oxifolic); (3) 5 mL/day of Oxo alone (magnesio', 'Folic acid supplementation', 'Dietary Supplementation', 'supplementation protocols: (1) traditional therapy (5-methyl-tetrahydrofolate', 'Oxoproline (Oxo']","['plasma homocysteine (Hcy) levels', 'Hcy level and Cys concentration', 'Thiols: cysteine (Cys), cysteinylglycine (Cys-Gly) and glutathione levels', 'Otherwise glutathione concentration']","[{'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}]","[{'cui': 'C1278165', 'cui_str': 'Plasma homocysteine measurement'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0056886', 'cui_str': 'cysteinylglycine'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",32.0,0.0328471,Every supplementation induced significant ( p  range <0.05-0.0001) reductions of Hcy level and Cys concentration after the three protocols adopted.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Vezzoli', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Dellanoce', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Teresa Maria', 'Initials': 'TM', 'LastName': 'Caimi', 'Affiliation': 'S.S Emostasi, S.C. Ematologia ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Vietti', 'Affiliation': ""Driatec srl, Cassina de' Pecchi, 20060 Milan, Italy.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Montorsi', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, 20122 Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Mrakic-Sposta', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Accinni', 'Affiliation': 'Institute of Clinical Physiology, National Council of Research (IFC-CNR), ASST Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy.'}]",Nutrients,['10.3390/nu12071957']
1959,32630079,Regular Consumption of Lipigo ®  Promotes the Reduction of Body Weight and Improves the Rebound Effect of Obese People Undergo a Comprehensive Weight Loss Program.,"Obesity is a global public health problem.
OBJECTIVE


To evaluate the effect of the regular consumption of the product Lipigo ®  on body weight and rebound effect on overweight/obese subjects undergoing a comprehensive weight loss program.
METHODS


A randomized, parallel, double-blind, placebo-controlled clinical trial was conducted with male and female subjects presenting a BMI 25-39.9 kg/m 2 . All subjects underwent a comprehensive weight loss program (WLP) for 12 weeks, which included an individualized hypocaloric diet, physical activity recommendations, nutritional education seminars, and three times a day consumption of the product Lipigo ®  or Placebo. After-WLP, subjects continued the treatment for 9 months to assess rebound effect. Body weight (BW), BMI, and body composition were measured at the beginning and the end of the WLP, and in the follow-up.
RESULTS


A total of 120 subjects (85% women) 49.0 ± 9.5 years old and with a BW of 81.57 ± 13.26 kg (BMI 31.19 ± 3.44 kg/m 2 ) were randomized and 73 subjects finished the study. At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group. However, subjects with obesity type 1 (OB1) from the treated group significantly reduced body weight (-5.27 ± 2.75 vs. -3.08 ± 1.73 kg; p = 0.017) and BMI (-1.99 ± 1.08 vs. -1.09 ± 0.55 kg/m 2 ; p = 0.01) compared with placebo. They also presented a minor rebound effect after 9 months with product consumption (-4.19 ± 3.61 vs. -1.44 ± 2.51 kg; p = 0.026), minor BMI (-1.61 ± 1.43 vs. -0.52 ± 0.96 kg/m 2 ; p = 0.025) and tended to have less fat-mass (-3.44 ± 2.46 vs. -1.44 ± 3.29 kg; p = 0.080) compared with placebo.
CONCLUSIONS


The regular consumption of the product Lipigo ®  promotes the reduction of body weight and reduces the rebound effect of obese people after 52 weeks (12 months), mainly in obesity type 1, who undergo a comprehensive weight loss program.",2020,"At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group.","['Obese People', '120 subjects (85% women) 49.0 ± 9.5 years old and with a BW of 81.57 ± 13.26 kg (BMI 31.19 ± 3.44 kg/m 2 ) were randomized and 73 subjects finished the study', 'overweight/obese subjects undergoing a comprehensive weight loss program', 'male and female subjects presenting a BMI 25-39.9 kg/m 2 ']","['comprehensive weight loss program (WLP', 'product Lipigo ®', 'individualized hypocaloric diet, physical activity recommendations, nutritional education seminars, and three times a day consumption of the product Lipigo ®  or Placebo', 'placebo']","['Body weight (BW), BMI, and body composition', 'body weight', 'BMI', 'Body Weight', 'reduced body weight', 'tendency toward reduced BW']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",120.0,0.0992394,"At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group.","[{'ForeName': 'Marlhyn', 'Initials': 'M', 'LastName': 'Valero-Pérez', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 2804 Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 2804 Madrid, Spain.'}, {'ForeName': 'Meritxell Aguiló', 'Initials': 'MA', 'LastName': 'García', 'Affiliation': 'AB-BIOTICS SA, Av. Torre Blanca 57, 08172 Sant Cugat del Valles, Spain.'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Palma-Milla', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, 28046 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, 28046 Madrid, Spain.'}]",Nutrients,['10.3390/nu12071960']
1960,32630164,The Application of Intra-Articulr Injections for Management of the Consequences of Disc Displacement without Reduction.,"The aim of the study was to make a comparative studies on the effectiveness of platelet rich plasma (PRP) and hyaluronic acid (HA) in intra-articular injections to the temporomandibular joints-in double blind studies application-based on the analysis of selected clinical parameters of functional efficiency and the mean value of joint's pain intensity before and after management. The study enrolled a group of 100 patients, aged 21 to 43 years, of both sexes, who came for the prosthodontic treatment. All patients had II b group of disorder according to the Research Diagnostic Criteria/Temporomandibular Disorder, and were consecutively, alternately assigned to the groups, 50 patients in each. Study group PRP was treated with intra-articular injection of platelet rich plasma and study group HA had injection with hyaluronic acid. The examination was double-blind, so that the injecting physician and the patient were not informed what kind of medicinal substance they received in the joint injection. The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures. The results of research showed that the use of PRP and HA in intraarticular joint's injections positively affects in selected clinical parameters and decrease of the pain in temporomandibular joints in the case of disc displacement without reduction.",2020,"The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures.","['All patients had II b group of disorder according to the Research Diagnostic Criteria/Temporomandibular Disorder', '100 patients, aged 21 to 43 years, of both sexes, who came for the prosthodontic treatment']","['platelet rich plasma (PRP) and hyaluronic acid (HA', 'hyaluronic acid']","['pain in temporomandibular joints', 'repair of intra-articular structures']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0155943', 'cui_str': 'Arthralgia of temporomandibular joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]",100.0,0.0469652,"The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures.","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Pihut', 'Affiliation': 'Prosthodontics Department, Consulting Room of Temporomandibular Disorders, Jagiellonian University, Medical College, 4 Montelupich Str., 31-155 Krakow, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Gala', 'Affiliation': 'Prosthodontics Department, Consulting Room of Temporomandibular Disorders, Jagiellonian University, Medical College, 4 Montelupich Str., 31-155 Krakow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17134726']
1961,32630188,Comparison of Aquatic Therapy vs. Dry Land Therapy to Improve Mobility of Chronic Stroke Patients.,"One of the most serious and disabling problems of stroke is pain and a decrease in balance, with the consequent increased risk of falls. The aim of the randomized controlled trial study was to compare the efficacy of three different treatment proposals to improve pain, gait, and balance in chronic stroke patients. Forty patients diagnosed with stroke were divided into three groups: the dry-land therapy group (control group) received sessions that included walking exercises and trunk mobility. The experimental group received Ai Chi aquatic therapy, and the combined group received alternating dry-land therapy sessions and Ai Chi aquatic therapy. The measurement instruments used were: the Tinetti balance and gait scale, the visual analog scale (VAS), 360° turn, single leg stance, and the 30-s stand test (CS-30). After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group. In total, for the Tinetti scale and single-leg stance, the differences between the groups were evident, although not statistically significant ( p  = 0.001). Aquatic therapy with Ai Chi and the combination of aquatic therapy with dry-land therapy was effective in improving pain, balance, and gait in patients with chronic stroke, thus improving their functional capacity and quality of life.",2020,"After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group.","['Chronic Stroke Patients', 'patients with chronic stroke', 'Forty patients diagnosed with stroke', 'chronic stroke patients']","['Aquatic Therapy vs. Dry Land Therapy', 'dry-land therapy group (control group) received sessions that included walking exercises and trunk mobility', 'Aquatic therapy with Ai Chi and the combination of aquatic therapy with dry-land therapy', 'Ai Chi aquatic therapy, and the combined group received alternating dry-land therapy sessions and Ai Chi aquatic therapy']","['pain, balance, and gait', 'Tinetti balance and gait scale, the visual analog scale (VAS), 360° turn, single leg stance, and the 30-s stand test (CS-30', 'Tinetti scale and single-leg stance', 'functional capacity and quality of life', 'pain, gait, and balance']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2732846', 'cui_str': 'Tinetti balance and gait scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0139959,"After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group.","[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, 04120 Almería, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134728']
1962,32630191,Acute Effects of Lixisenatide on Energy Intake in Healthy Subjects and Patients with Type 2 Diabetes: Relationship to Gastric Emptying and Intragastric Distribution.,"Glucagon-like peptide-1 receptor agonists induce weight loss, which has been suggested to relate to the slowing of gastric emptying (GE). In health, energy intake (EI) is more strongly related to the content of the distal, than the total, stomach. We evaluated the effects of lixisenatide on GE, intragastric distribution, and subsequent EI in 15 healthy participants and 15 patients with type 2 diabetes (T2D). Participants ingested a 75-g glucose drink on two separate occasions, 30 min after lixisenatide (10 mcg) or placebo subcutaneously, in a randomised, double-blind, crossover design. GE and intragastric distribution were measured for 180 min followed by a buffet-style meal, where EI was quantified. Relationships of EI with total, proximal, and distal stomach content were assessed. In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001). EI was not related to the content of the total or proximal stomach but inversely related to the distal stomach at 180 min in health on placebo ( r  = -0.58,  p =  0.03) but not in T2D nor after lixisenatide in either group. In healthy and T2D participants, the reduction in EI by lixisenatide is unrelated to changes in GE/intragastric distribution, consistent with a centrally mediated effect.",2020,"In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001).","['Healthy Subjects and Patients with Type 2 Diabetes', '15 healthy participants and 15 patients with type 2 diabetes (T2D']","['lixisenatide', '75-g glucose drink', 'Lixisenatide', 'placebo']","['Energy Intake', 'GE and intragastric distribution', 'weight loss', 'Relationships of EI with total, proximal, and distal stomach content', 'distal stomach', 'content of the total or proximal stomach']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1267582', 'cui_str': 'Proximal stomach structure'}]",15.0,0.0659903,"In both groups, lixisenatide slowed GE markedly, with increased retention in both the proximal ( p  < 0.001) and distal ( p  < 0.001) stomach and decreased EI ( p  < 0.001).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jalleh', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Chinmay S', 'Initials': 'CS', 'LastName': 'Marathe', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Madeline D', 'Initials': 'MD', 'LastName': 'Buttfield', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide SA 5001, Australia.'}, {'ForeName': 'Seva', 'Initials': 'S', 'LastName': 'Hatzinikolas', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Malbert', 'Affiliation': 'Aniscan, Institut National de la Rechercher Agronomique, 35590 Saint-Gilles, France.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Rigda', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Laurence G', 'Initials': 'LG', 'LastName': 'Trahair', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School, Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide SA 5000, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA 5000, Australia.'}]",Nutrients,['10.3390/nu12071962']
1963,32630214,Effects of Exercise Training during Christmas on Body Weight and Cardiometabolic Health in Overweight Individuals.,":  Individuals with abdominal obesity and metabolic syndrome (MetS) have augmented risk of all-cause mortality. Lifestyle interventions are effective to treat MetS, however, there are periods during the year in which exercise programs are discontinued and improper dietary habits reappear (e.g., Christmas holidays). We aimed to analyze if exercise-training during Christmas holidays would avoid body-weight gains and cardiometabolic deterioration in MetS individuals, using a randomized control trial. Thirty-eight men with MetS undergoing exercise training were randomly allocated to either continue (TRAIN group, n = 16) or discontinue (HOLID group, n = 22) training, during the three weeks of Christmas. Anthropometrics (body weight, fat, and waist circumference), fasting blood metabolites (glucose, insulin, triglycerides, and cholesterol concentrations) and exercise maximal fat oxidation (FO MAX ) and oxygen uptake (VO 2PEAK ) were determined before and after Christmas. Both groups were similar at baseline in all parameters ( p  > 0.05). HOLID group increased body weight (91.3 ± 13.0 to 92.0 ± 13.4 kg,  p  = 0.004), mean arterial pressure (94.0 ± 10.6 to 97.1 ± 8.9 mmHg,  p  = 0.026), blood insulin (10.2 ± 3.8 to 12.5 ± 5.4 µIU·mL -1 ,  p  = 0.003) and HOMA (3.2 ± 1.3 to 4.1 ± 2.3,  p  = 0.003). In contrast, TRAIN prevented those disarrangements and reduced total (170.6 ± 30.6 to 161.3 ± 31.3 mg·dL -1 ,  p  = 0.026) and low-density lipoprotein cholesterol (i.e., LDL- C , 104.8 ± 26.1 to 95.6 ± 21.7 mg·dL -1 ,  p  = 0.013). TRAIN also prevented the reductions in exercise FO MAX  and VO 2PEAK  that was observed in the HOLID group ( p  = 0.002). In conclusion, exercise training during Christmas, prevents body weight gains and the associated cardiovascular (increase in blood pressure and LDL -C ) and metabolic (reduced insulin sensitivity) health risks are an optimal non-pharmacological therapy for that period of the year.",2020,Both groups were similar at baseline in all parameters ( p  > 0.05).,"['  Individuals with abdominal obesity and metabolic syndrome (MetS', 'Overweight Individuals', 'Thirty-eight men with MetS undergoing exercise training']","['exercise training', 'Exercise Training', 'discontinue (HOLID group, n = 22) training', 'exercise-training']","['body weight gains', 'blood insulin', 'body weight', 'low-density lipoprotein cholesterol', 'Body Weight and Cardiometabolic Health', 'blood pressure and LDL -C ) and metabolic (reduced insulin sensitivity) health risks', 'exercise FO MAX  and VO 2PEAK', 'mean arterial pressure', 'Anthropometrics (body weight, fat, and waist circumference), fasting blood metabolites (glucose, insulin, triglycerides, and cholesterol concentrations) and exercise maximal fat oxidation (FO MAX ) and oxygen uptake (VO 2PEAK ']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",38.0,0.0169114,Both groups were similar at baseline in all parameters ( p  > 0.05).,"[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Valle', 'Initials': 'V', 'LastName': 'Guio de Prada', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134732']
1964,32630241,Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.,"Few studies have considered the effects of percutaneous electrolysis (PE) in the treatment of lateral epicondylalgia (LE). For this reason, the objective of this study was to compare the effects of PE with an evidence-based approach-trigger point dry needling (TDN)-in patients with LE. A randomized controlled trial was conducted in which 32 participants with LE were randomly assigned to two treatment groups, the PE group ( n  = 16) and the TDN group ( n  = 16). Both groups received four therapy sessions and an eccentric exercise program to be performed daily. The numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion were measured before treatment, at the end of treatment, and at one- and three-month follow-ups. Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006). At one-month follow-up, significant mean differences between groups were found for NPRS ( p  < 0.001), PPT ( p  = 0.021), and flexion ( p  = 0.036). At three-months follow-up, significant mean differences between groups were found for NPRS ( p  < 0.001), PPT ( p  = 0.004), and flexion ( p  = 0.003). This study provides evidence that PE could be more effective than TDN for short- and medium-term improvement of pain and PPTs in LE when added to an eccentric exercise program.",2020,Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006).,"['patients with LE', '32 participants with LE', 'Lateral Epicondylalgia']","['PE with an evidence-based approach-trigger point dry needling (TDN)-in', 'TDN', 'percutaneous electrolysis (PE', 'Percutaneous Electrolysis', 'PE', 'eccentric exercise program']","['numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion', 'NPRS', 'flexion movement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",32.0,0.110392,Significant between-group mean differences were found after treatment for NPRS ( p  < 0.001) and flexion movement ( p  = 0.006).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Nursery and Physiotherapy, University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Góngora-Rodríguez', 'Affiliation': 'Policlínica Santa María Clinic, 11008 Cádiz, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martín-Valero', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Málaga, 29071 Málaga, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Díaz-Fernández', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Obrero-Gaitán', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez-Almagro', 'Affiliation': 'Department of Health Sciences, University of Jaén, Campus las Lagunillas, 23071 Jaén, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072068']
1965,32630290,Investigation of the Enhancement Interactions between Double Parallel Cracks on Fatigue Growth Behaviors.,"In this paper, interactions of double parallel cracks were studied by performing experiments and numerical simulations. Fatigue crack propagation tests were carried out to measure crack growth rates in the specimens with double parallel cracks or a single crack. Finite element method was adopted to calculate stress intensity factors at the crack tips. Results show that the double parallel cracks at different positions present a shielding effect or enhancement effect on crack growth rates and stress intensity factors. When the double parallel cracks are offset, crack interactions mostly behave as enhancement effects. Empirical formulas were obtained to calculate the stress intensity factor at the ""dangerous"" crack tip of the double parallel cracks. By modifying the material parameters in Paris equation of the single crack, the double parallel cracks are simplified into a single crack with the same crack growth rates.",2020,Fatigue crack propagation tests were carried out to measure crack growth rates in the specimens with double parallel cracks or a single crack.,[],[],"['crack growth rates', 'Fatigue Growth Behaviors', 'crack growth rates and stress intensity factors']",[],[],"[{'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0674001,Fatigue crack propagation tests were carried out to measure crack growth rates in the specimens with double parallel cracks or a single crack.,"[{'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Institute of Mechanical and Electrical Engineering, Beijing University of Chemical Technology, Beijing 100029, China.'}, {'ForeName': 'Caifu', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Institute of Mechanical and Electrical Engineering, Beijing University of Chemical Technology, Beijing 100029, China.'}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Mechanical and Electrical Engineering, Beijing University of Chemical Technology, Beijing 100029, China.'}]","Materials (Basel, Switzerland)",['10.3390/ma13132952']
1966,32630373,Shoes and Insoles: The Influence on Motor Tasks Related to Walking Gait Variability and Stability.,"The rhythmic control of the lower limb muscles influences the cycle-to-cycle variability during a walking task. The benefits of insoles, commonly used to improve the walking gait, have been little studied. Therefore, the aim of this study was to assess the walking gait variability and stability on different walking conditions (without shoes, WTS, with shoes, WS, with shoes and insoles, WSI) related to brain activity. Twelve participants randomly (WTS/WS/WSI) walked on a treadmill at 4 km/h for 10 min. Kinematic analysis (i.e., footstep and gait variability), brain activation (beta wave signal), rating of perceived exertion (RPE, CR-10 scale), and time domain measures of walking variability were assessed. The maximum Lyapunov exponent (LyE) on the stride cycle period's datasets was also calculated. Stride length and cycle calculated for all walking conditions were 61.59 ± 2.53/63.38 ± 1.43/64.09 ± 2.40 cm and 1.11 ± 0.03/1.14 ± 0.03/1.15 ± 0.04 s (F 1,10  = 4.941/ p  = 0.01, F 1,10  = 4.938/ p  = 0.012) for WTS, WS, WSI, respectively. Beta wave (F 1,10  = 564.201/ p  = 0.0001) was higher in WTS compared to WS and WSI. Analysis of variance's (ANOVA) LyE showed a F 1,10  = 3.209/ p  = 0.056, while post hoc analysis showed a significant effect between WS and WSI with  p  = 0.023, and nonsignificant effects between WTS and WS/WSI ( p  = 0.070/0.607), respectively. Small perturbations of the foot can influence the control of gait rhythmicity by increasing the variability in a dissipative deterministic regimen.",2020,p  = 0.0001) was higher in WTS compared to WS and WSI.,['Shoes and Insoles'],[],"['Motor Tasks Related to Walking Gait Variability and Stability', 'Kinematic analysis (i.e., footstep and gait variability), brain activation (beta wave signal), rating of perceived exertion (RPE, CR-10 scale), and time domain measures of walking variability', 'Stride length and cycle calculated', 'walking gait variability and stability on different walking conditions']","[{'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C3873740', 'cui_str': 'Insole'}]",[],"[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",12.0,0.0635959,p  = 0.0001) was higher in WTS compared to WS and WSI.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Russo', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, 67100 L'Aquila, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Di Capua', 'Affiliation': 'Department of Physics ""E. Pancini"", University of Naples ""Federico II"", and CNR-SPIN Institute, 80126 Naples, Italy.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Arnone', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, 67100 L'Aquila, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Borrelli', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Coppola', 'Affiliation': 'Faculty of Human and Society Sciences-University of Enna ""Kore"", 94100 Enna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Padulo', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124569']
1967,32630387,"The Efficacy of Rotary, Reciprocating, and Combined Non-Surgical Endodontic Retreatment Techniques in Removing a Carrier-Based Root Canal Filling Material from Straight Root Canal Systems: A Micro-Computed Tomography Analysis.","The aim of this study is to analyze and compare the efficacy of three non-surgical endodontic retreatment techniques in removing a carrier-based root canal filling material from straight root canal systems. The study was performed on 99 single-rooted extracted teeth using the ProTaper Gold endodontic rotary system up to the F2 file (Dentsply Maillefer, Baillagues, Switzerland), which were sealed with GuttaCore (Dentsply Maillefer, Ballaigues, Switzerland) and AH plus epoxy resin sealer (Dentsply DeTrey, Konstanz, Germany) and randomly assigned to the following non-surgical retreatment techniques: ProTaper Retreatment endodontic rotary instruments (D1-D3 files, Dentsply Maillefer, Ballaigues, Switzerland;  n  = 33, PTR), Reciproc Blue endodontic reciprocating instrument (R50, VDW, Munich, Germany;  n  = 33, RCB50), and a combined root canal retreatment technique between Gates-Glidden drills (sizes #3 and #2, Dentsply Maillefer, Ballaigues, Switzerland) and Hedstrom files (file size 35, 30, and 25, Dentsply Maillefer, Ballaigues, Switzerland;  n  = 33; H-GG). All of the teeth were submitted twice to a micro-computed tomography (micro-CT) scan, before and after non-surgical endodontic retreatment procedures. The volume of root canal filling material (mm 3 ), volume of remaining root canal filling material (mm 3 ), non-surgical endodontic retreatment working time (min), proportion of remaining root canal filling material (%), and efficacy of root canal filling material removal between the non-surgical endodontic retreatment techniques were analyzed using ANOVA one-way statistical analysis. Statistically significant differences were observed between the proportions of remaining root canal filling material of PTR and H-GG ( p =  0.018), between the non-surgical endodontic retreatment working times (min;  p  < 0.001), and between the efficacies of root canal filling material removal by the non-surgical endodontic retreatment techniques ( p  = 0.009). However, the non-surgical endodontic retreatment systems allow for similar carrier-based root canal filling material removal.",2020,"Statistically significant differences were observed between the proportions of remaining root canal filling material of PTR and H-GG ( p =  0.018), between the non-surgical endodontic retreatment working times (min;  p  < 0.001), and between the efficacies of root canal filling material removal by the non-surgical endodontic retreatment techniques ( p  = 0.009).","['Removing a Carrier-Based Root Canal Filling Material from Straight Root Canal Systems', '99 single-rooted extracted teeth using the']","['ProTaper Gold endodontic rotary system up to the F2 file (Dentsply Maillefer, Baillagues, Switzerland), which were sealed with GuttaCore (Dentsply Maillefer, Ballaigues, Switzerland) and AH plus epoxy resin sealer (Dentsply DeTrey, Konstanz, Germany) and randomly assigned to the following non-surgical retreatment techniques: ProTaper Retreatment endodontic rotary instruments (D1-D3 files, Dentsply Maillefer, Ballaigues, Switzerland;  n  = 33, PTR), Reciproc Blue endodontic reciprocating instrument (R50, VDW, Munich, Germany;  n  = 33, RCB50), and a combined root canal retreatment technique between Gates-Glidden drills', 'Rotary, Reciprocating, and Combined Non-Surgical Endodontic Retreatment Techniques']","['volume of root canal filling material (mm 3 ), volume of remaining root canal filling material (mm 3 ), non-surgical endodontic retreatment working time (min), proportion of remaining root canal filling material (%), and efficacy of root canal filling material removal', 'proportions of remaining root canal filling material of PTR and H-GG', 'efficacies of root canal filling material removal']","[{'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0206711', 'cui_str': 'Pilomatrixoma'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0398946', 'cui_str': 'Periapical surgery of tooth'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0398946', 'cui_str': 'Periapical surgery of tooth'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0206711', 'cui_str': 'Pilomatrixoma'}]",99.0,0.0221559,"Statistically significant differences were observed between the proportions of remaining root canal filling material of PTR and H-GG ( p =  0.018), between the non-surgical endodontic retreatment working times (min;  p  < 0.001), and between the efficacies of root canal filling material removal by the non-surgical endodontic retreatment techniques ( p  = 0.009).","[{'ForeName': 'Tarek-Fahed', 'Initials': 'TF', 'LastName': 'Alakabani', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Faus-Llácer', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Faus-Matoses', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Ruiz-Sánchez', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Zubizarreta-Macho', 'Affiliation': 'Department of Endodontics, Faculty of Health Sciences, Alfonso X El Sabio University, 28691 Madrid, Spain.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Sauro', 'Affiliation': 'Department of Dentistry, Faculty of Health Sciences, CEU Cardenal Herrera University, 46115 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Faus-Matoses', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010 Valencia, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061989']
1968,32630511,Abnormalities on Perfusion CT and Intervention for Intracranial Hypertension in Severe Traumatic Brain Injury.,"The role of invasive intracranial pressure (ICP) monitoring in patients with severe traumatic brain injury (STBI) remain unclear. Perfusion computed tomography (CTP) provides crucial information about the cerebral perfusion status in these patients. We hypothesised that CTP abnormalities would be associated with the severity of intracranial hypertension (ICH). To investigate this hypothesis, twenty-eight patients with STBI and ICP monitors were investigated with CTP within 48 h from admission. Treating teams were blind to these results. Patients were divided into five groups based on increasing intervention required to control ICH and were compared. Group I required no intervention above routine sedation, group II required a single first tier intervention, group III required multiple different first-tier interventions, group IV required second-tier medical therapy and group V required second-tier surgical therapy. Analysis of the results showed demographics and injury severity did not differ among groups. In group I no patients showed CTP abnormality, while patients in all other groups had abnormal CTP ( p  = 0.003). Severe ischaemia observed on CTP was associated with increasing intervention for ICH. This study, although limited by small sample size, suggests that CTP abnormalities are associated with the need to intervene for ICH. Larger scale assessment of our results is warranted to potentially avoid unnecessary invasive procedures in head injury patients.",2020,"In group I no patients showed CTP abnormality, while patients in all other groups had abnormal CTP ( p  = 0.003).","['Severe Traumatic Brain Injury', 'head injury patients', 'patients with severe traumatic brain injury (STBI', 'twenty-eight patients with STBI and ICP monitors']","['invasive intracranial pressure (ICP) monitoring', 'CTP', 'no intervention above routine sedation, group II required a single first tier intervention, group III required multiple different first-tier interventions, group IV required second-tier medical therapy and group V required second-tier surgical therapy', 'Perfusion CT and Intervention', 'Perfusion computed tomography (CTP']","['abnormal CTP', 'demographics and injury severity', 'CTP abnormality', 'severity of intracranial hypertension (ICH', 'Severe ischaemia']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0150260', 'cui_str': 'Intracranial pressure monitoring regime'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0441855', 'cui_str': 'Group V'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",28.0,0.0145531,"In group I no patients showed CTP abnormality, while patients in all other groups had abnormal CTP ( p  = 0.003).","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Cooper', 'Affiliation': 'Department of Traumatology, John Hunter Hospital Newcastle, Newcastle, NSW 2305, Australia.'}, {'ForeName': 'Cino', 'Initials': 'C', 'LastName': 'Bendinelli', 'Affiliation': 'Department of Traumatology, John Hunter Hospital Newcastle, Newcastle, NSW 2305, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, NSW 2300, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, NSW 2300, Australia.'}, {'ForeName': 'Zsolt J', 'Initials': 'ZJ', 'LastName': 'Balogh', 'Affiliation': 'Department of Traumatology, John Hunter Hospital Newcastle, Newcastle, NSW 2305, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9062000']
1969,32630541,Brief Psychological Intervention Through Mobile App and Conference Calls for the Prevention of Depression in Non-Professional Caregivers: A Pilot Study.,"Despite its potential, no intervention aimed at non-professional caregivers administered through a smartphone app has been proven to prevent depression. The objective of this pilot study was to evaluate the efficacy and feasibility of an indicated depression-prevention intervention for non-professional caregivers administered through an app with the addition of conference-call contact. The intervention was administered to 31 caregivers (Mean age = 54.0 years, 93.5% women). An independent evaluation determined the incidence of depression, depressive symptoms, risk of developing depression, and the variables in the theoretical model (positive environmental reinforcement, negative automatic thoughts) at the pre-intervention and post-intervention, as well as the one- and three-month follow-ups. The incidence of depression at 3 months of follow-up was 6.5%. There was a significant reduction in depressive symptoms ( p  < 0.001) and in the risk of developing depression ( p  < 0.001) at the post-intervention and at the one- and three-month follow-ups. The model's variables improved significantly after the intervention and were associated with post-intervention depressive symptoms. The intervention was more effective in caregivers who had a lower level of depressive symptoms at the pre-intervention. Adherence and satisfaction with the intervention were high. The results encourage future research using a randomized controlled clinical trial.",2020,There was a significant reduction in depressive symptoms ( p  < 0.001) and in the risk of developing depression ( p  < 0.001) at the post-intervention and at the one- and three-month follow-ups.,"['Non-Professional Caregivers', '31 caregivers (Mean age = 54.0 years, 93.5% women', 'non-professional caregivers administered through an app with the addition of conference-call contact']","['depression-prevention intervention', 'Brief Psychological Intervention Through Mobile App and Conference Calls']","['incidence of depression, depressive symptoms, risk of developing depression', 'Adherence and satisfaction', 'depressive symptoms', 'incidence of depression', 'efficacy and feasibility', 'risk of developing depression']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0575702,There was a significant reduction in depressive symptoms ( p  < 0.001) and in the risk of developing depression ( p  < 0.001) at the post-intervention and at the one- and three-month follow-ups.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, 15071 A Coruña, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hita', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela J', 'Initials': 'ÁJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124578']
1970,32630549,"Development of a Tailored, Complex Intervention for Clinical Reflection and Communication about Suspected Urinary Tract Infections in Nursing Home Residents.","BACKGROUND


Inappropriate antibiotic treatments for urinary tract infections (UTIs) in nursing homes cause the development of resistant bacteria. Nonspecific symptoms and asymptomatic bacteriuria are drivers of overtreatment. Nursing home staff provide general practice with information about ailing residents; therefore, their knowledge and communication skills influence prescribing. This paper describes the development of a tailored, complex intervention for a cluster-randomised trial that targets the knowledge of UTI and communication skills in nursing home staff to reduce antibiotic prescriptions.
METHODS


A dialogue tool was drafted, drawing on participatory observations in nursing homes, interviews with stakeholders, and a survey in general practice. The tool was tailored through a five-phase process that included stakeholders. Finally, the tool and a case-based educational session were tested in a pilot study.
RESULTS


The main barriers were that complex patients were evaluated by healthcare staff with limited knowledge about disease and clinical reasoning; findings reported to general practice were insignificant and included vague descriptions; there was evidence of previous opinion bias; nonspecific symptoms were interpreted as UTI; intuitive reasoning led to the inappropriate suspicion of UTI.
CONCLUSION


Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.",2020,Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.,"['Nursing Home Residents', 'nursing homes, interviews with stakeholders, and a survey in general practice']",['Complex Intervention'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0666822,Sustainable change in antibiotic-prescribing behaviour in nursing homes requires a change in nursing home staff's beliefs about and management of UTIs.,"[{'ForeName': 'Sif H', 'Initials': 'SH', 'LastName': 'Arnold', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Olesen', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Jette N', 'Initials': 'JN', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Holm', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}, {'ForeName': 'Marius B', 'Initials': 'MB', 'LastName': 'Kousgaard', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Building 24 Q, K 1353 Copenhagen, Denmark.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9060360']
1971,32630571,The Effect of Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) on P3 Event-Related Potentials during a Bayesian Oddball Task.,"Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity. NE is suspected to contribute to generation of the P3 event-related potential. Recent evidence has produced equivocal evidence whether taVNS influences the P3 in healthy individuals during oddball tasks. We examined the effect of taVNS on P3 amplitudes using a novel visual Bayesian oddball task, which presented 200 sequences of three stimuli. The three consecutive stimuli in each sequence are labelled Draw 1, Draw 2 and Draw 3. In total, 47 Subjects completed this visual Bayesian oddball task under randomised sham and active taVNS stimulation in parallel with an electroencephalographic (EEG) recording. We conducted exploratory analyses of the effect of taVNS on P3 amplitudes separately for Draws. We found typical oddball effects on P3 amplitudes at Draws 1 and 2, but not Draw 3. At Draw 2, the oddball effect was enhanced during active compared to sham taVNS stimulation. These data provide evidence that taVNS influences parietal P3 amplitudes under specific circumstances. Only P3 amplitudes at Draw 2 were affected, which may relate to closure of Bayesian inference after Draw 2. Our findings seemingly support previously reported links between taVNS and the NE system.",2020,Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity.,"['47 Subjects completed this', 'healthy individuals during oddball tasks']","['Transcutaneous Auricular Vagal Nerve Stimulation (taVNS', 'visual Bayesian oddball task under randomised sham and active taVNS stimulation in parallel with an electroencephalographic (EEG) recording', 'taVNS', 'Transcutaneous auricular Vagal Nerve Stimulation (taVNS', 'NE']",['P3 amplitudes'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],47.0,0.0951838,Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique associated with possible modulation of norepinephrinergic (NE) activity.,"[{'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Warren', 'Affiliation': 'Clinic of Neurology, Hannover Medical School, 30519 Hannover, Germany.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Maraver', 'Affiliation': 'Institute of Psychology, Leiden University, 2333 Leiden, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de Luca', 'Affiliation': 'Institute of Psychology, Leiden University, 2333 Leiden, The Netherlands.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Kopp', 'Affiliation': 'Clinic of Neurology, Hannover Medical School, 30519 Hannover, Germany.'}]",Brain sciences,['10.3390/brainsci10060404']
1972,32630629,The Migration Pattern of a Cementless Hydroxyapatite-Coated Titanium Stem under Immediate Full Weight-Bearing-A Randomized Controlled Trial Using Model-Based RSA.,"(1) Background: High primary stability is important for the long-term survival of cementless femoral stems in total hip arthroplasty (THA). The objective of this study was to investigate the migration pattern of a hydroxyapatite-coated cementless hip stem developed for minimally invasive surgery using model-based radiostereometric analysis (RSA). (2) Methods: In this randomized controlled trial, 44 patients with an indication for cementless primary THA were randomly allocated to receive either the SL-PLUS MIA stem, developed for minimally invasive surgery, or the SL-PLUS stem (Smith & Nephew Orthopaedics, Baar, Switzerland) which served as a control group. Unlimited weight-bearing was permitted postoperatively in both groups. Model-based RSA was performed after six weeks and after 3, 6, 12 and 24 months postoperatively. (3) Results: Mean total stem subsidence at two-year follow-up was 0.40 mm (SD 0.66 mm) in the SL-PLUS group and 1.08 mm (SD 0.93 mm) in the SL-PLUS MIA group ( p  = 0.030). Stem subsidence occurred during the first six weeks after surgery, indicating initial settling of the stem under full weight-bearing. Both stem designs showed good osseointegration and high secondary stability with no further migration after initial settling. (4) Conclusions: Settling of a cementless straight femoral stem occurs during the first six weeks after surgery under full weight-bearing. Although initial stem migration was higher in the SL-PLUS MIA group, it had no influence on secondary stability. All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.",2020,All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.,"['total hip arthroplasty (THA', '44 patients with an indication for cementless primary THA']","['hydroxyapatite-coated cementless hip stem', 'SL-PLUS MIA stem, developed for minimally invasive surgery, or the SL-PLUS stem (Smith & Nephew Orthopaedics, Baar, Switzerland) which served as a control group', 'minimally invasive surgery using model-based radiostereometric analysis (RSA', 'Cementless Hydroxyapatite-Coated Titanium Stem']","['Mean total stem subsidence', 'Stem subsidence', 'good osseointegration and high secondary stability with no signs of implant loosening', 'secondary stability']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0337579', 'cui_str': 'Nephew'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",44.0,0.120705,All implants showed good osseointegration and high secondary stability with no signs of implant loosening during this two-year follow-up period.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Reiner', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': 'Laboratory of Biomechanics and Implant Research, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstr. 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Jan Philippe', 'Initials': 'JP', 'LastName': 'Kretzer', 'Affiliation': 'Laboratory of Biomechanics and Implant Research, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstr. 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clarius', 'Affiliation': 'Department for Orthopedics and Traumatology, Vulpius Klinik GmbH, Vulpiusstrasse 29, 74906 Bad Rappenau, Germany.'}, {'ForeName': 'Eike', 'Initials': 'E', 'LastName': 'Jakubowitz', 'Affiliation': 'Laboratory for Biomechanics and Biomaterials, Department of Orthopaedic Surgery, Hannover Medical School, Anna-von-Borries-Str. 1-7, 30625 Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'ARCUS Clinics Pforzheim, Rastatter Str. 17-19, 75179 Pforzheim, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Ewerbeck', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Merle', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kinkel', 'Affiliation': 'ARCUS Clinics Pforzheim, Rastatter Str. 17-19, 75179 Pforzheim, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gotterbarm', 'Affiliation': 'Department for Orthopedics and Traumatology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Krankenhausstrasse 9, 4020 Linz and Altenberger Strasse 69, 4040 Linz, Austria.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hagmann', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118 Heidelberg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9072077']
1973,32630663,Intensive Motion Style Acupuncture Treatment (MSAT) Is Effective for Patients with Acute Whiplash Injury: A Randomized Controlled Trial.,"In this single-center, parallel, randomized controlled trial, we aim to examine the effects and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) on pain reduction and functional improvement in patients with whiplash-associated disorders (WADs). Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury were treated with integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT during hospitalization (5-14 days) and followed-up for 90 days. The mean numeric rating scale (NRS) scores of the MSAT and control groups at baseline were 5.67 (95% confidence interval (CI), 5.33, 6.01) and 5.44 (95% CI, 5.06, 5.82), respectively, and on day 5, 3.55 (95% CI, 3.04, 4.06) and 4.59 (95% CI, 4.10-5.07), respectively. The NRS change difference between the groups was -1.07 (95% CI, -1.76, -0.37). The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055). IKM treatment combined with MSAT may be effective in reducing the pain and improving the range of motion in patients with WADs.",2020,The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055).,"['Patients with Acute Whiplash Injury', 'patients with WADs', 'Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury', 'patients with whiplash-associated disorders (WADs']","['Intensive Motion Style Acupuncture Treatment (MSAT', 'acupuncture and Doin therapy', 'integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT', 'MSAT', 'motion style acupuncture treatment (MSAT']","['NRS change difference', 'mean numeric rating scale (NRS) scores', 'pain', 'pain reduction and functional improvement', 'rate of recovery of neck pain (NRS score change ≥ 2 points']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",97.0,0.231885,The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test  p  = 0.0055).,"[{'ForeName': 'Doori', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Kyoung-Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundations, Gangnam-gu, Seoul 100011, Korea.'}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Gangnam-gu, Seoul 100011, Korea.'}, {'ForeName': 'Won-Hyung', 'Initials': 'WH', 'LastName': 'Ryu', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Heeyoung', 'Initials': 'H', 'LastName': 'Moon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Yong-Hyun', 'Initials': 'YH', 'LastName': 'Jeon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Moon', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Namgoong', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon 420010, Korea.'}, {'ForeName': 'Byung-Cheul', 'Initials': 'BC', 'LastName': 'Shin', 'Affiliation': 'School of Korean Medicine, Pusan National University, Yangsan, Kyungnam 50612, Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundations, Gangnam-gu, Seoul 100011, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9072079']
1974,32630697,Leptin and Nutrition in Gestational Diabetes.,"Leptin is highly expressed in the placenta, mainly by trophoblastic cells, where it has an important autocrine trophic effect. Moreover, increased leptin levels are found in the most frequent pathology of pregnancy: gestational diabetes, where leptin may mediate the increased size of the placenta and the fetus, which becomes macrosomic. In fact, leptin mediates the increased protein synthesis, as observed in trophoblasts from gestational diabetic subjects. In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9. The high plasma leptin levels found in gestational diabetes may be potentiated by leptin resistance at a central level, and obesity-associated inflammation plays a role in this leptin resistance. Therefore, the importance of anti-inflammatory nutrients to modify the pathology of pregnancy is clear. In fact, nutritional intervention is the first-line approach for the treatment of gestational diabetes mellitus. However, more nutritional intervention studies with nutraceuticals, such as polyphenols or polyunsaturated fatty acids, or nutritional supplementation with micronutrients or probiotics in pregnant women, are needed in order to achieve a high level of evidence. In this context, the Mediterranean diet has been recently found to reduce the risk of gestational diabetes in a multicenter randomized trial. This review will focus on the impact of maternal obesity on placental inflammation and nutrients transport, considering the mechanisms by which leptin may influence maternal and fetal health in this setting, as well as its role in pregnancy pathologies.",2020,"In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9.","['pregnant women', 'gestational diabetes mellitus', 'Gestational Diabetes', 'gestational diabetic subjects']",[],"['protein synthesis', 'leptin levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0142626,"In addition, leptin seems to facilitate nutrients transport to the fetus in gestational diabetes by increasing the expression of the glycerol transporter aquaporin-9.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pérez-Pérez', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Vilariño-García', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Guadix', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Dueñas', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen Macarena University Hospital, 41009 Seville, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Sánchez-Margalet', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, and Immnology, School of Medicine, Virgen Macarena University Hospital, 41009 Seville, Spain.'}]",Nutrients,['10.3390/nu12071970']
1975,32630786,Bifidobacterium longum subsp. longum  OLP-01 Supplementation during Endurance Running Training Improves Exercise Performance in Middle- and Long-Distance Runners: A Double-Blind Controlled Trial.,"Bifidobacterium longum subsp. longum  Olympic No. 1 (OLP-01) has been shown in previous animal experiments to improve exercise endurance performance, but this effect has not been confirmed in humans, or more particularly, in athletes. Toward this end, the current study combined OLP-01 supplementation with regular exercise training in well-trained middle- and long-distance runners at the National Taiwan Sport University. The study was designed as a double-blind placebo-controlled experiment. Twenty-one subjects (14 males and seven females aged 20-30 years) were evenly distributed according to total distance (meters) traveled in 12 min to one of the following two groups: a placebo group (seven males and three females) and an OLP-01 (1.5 × 10 10  colony forming units (CFU)/day) group (seven males and four females). All the participants received placebo or OLP-01 supplements for five consecutive weeks consisting of three weeks of regular training and two weeks of de-training. Before and after the experiment, the participants were tested for 12-min running/walking distance, and body composition, blood/serum, and fecal samples were analyzed. The results showed that OLP-01 significantly increased the change in the 12-min Cooper's test running distance and the abundance of gut microbiota. Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies. In summary, OLP-01 can be used as a sports nutrition supplement, especially for athletes, to improve exercise performance.",2020,"Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies.","['well-trained middle- and long-distance runners at the National Taiwan Sport University', 'Middle- and Long-Distance Runners', 'group (seven males and three females) and an OLP-01 (1.5 × 10 10  colony forming units (CFU)/day) group (seven males and four females', 'Twenty-one subjects (14 males and seven females aged 20-30 years']","['placebo or OLP-01 supplements', 'Bifidobacterium longum subsp', 'longum', 'OLP-01 supplementation with regular exercise training', 'Endurance Running Training', 'placebo']","['Exercise Performance', 'exercise endurance performance', 'body composition', ""12-min Cooper's test running distance and the abundance of gut microbiota"", 'OLP-01', 'exercise performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.105597,"Although no significant change in body composition was found, OLP-01 caused no adverse reactions or harm to the participants' bodies.","[{'ForeName': 'Che-Li', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Hsieh-Hsun', 'Initials': 'HH', 'LastName': 'Ho', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Yung-Cheng', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Training Science-Athletics, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Yi-Wei', 'Initials': 'YW', 'LastName': 'Kuo', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Yao-Tsung', 'Initials': 'YT', 'LastName': 'Yeh', 'Affiliation': 'Department of Medical Laboratory Sciences and Biotechnology, Fooyin University, Kaohsiung City 83102, Taiwan.'}, {'ForeName': 'Shin-Yu', 'Initials': 'SY', 'LastName': 'Tsai', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Ching-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Jui-Fen', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Glac Biotech Co., Ltd., Tainan City 74442, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}, {'ForeName': 'Mon-Chien', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan City 33301, Taiwan.'}]",Nutrients,['10.3390/nu12071972']
1976,32630973,Validation of a Circulating Tumor-Derived DNA Blood Test for Detection of Methylated BCAT1 and IKZF1 DNA.,"BACKGROUND


Colvera™ is a test that detects circulating tumor-derived DNA in patients with colorectal cancer by assaying for the presence of methylated BCAT1 and IKZF1 in blood. This study describes the analytical and clinical performance characteristics of the test.
METHODS


Validation was performed in accordance with ISO15189 and National Pathology Accreditation Advisory Council requirements. Spiked samples including 264 plasma and 120 buffer samples were randomized, divided into 8 batches of 48 samples, and processed over 8 days using 2 equipment lines (each line consisting of a QIAsymphony SP/AS, QIACube HT, and LC480); 2 reagent batches; and 2 operators to determine limit of detection, selectivity/specificity, precision, reproducibility, ruggedness, and susceptibility to commonly known interfering substances. Clinical performance was validated by assaying 222 archived plasma samples from subjects (n = 26 with cancer) enrolled in a previous prospective trial.
RESULTS


The limit of detection for Colvera was 12.6 pg/mL (95% CI, 8.6-23.9 pg/mL), which equates to 2 diploid genome copies per milliliter plasma. No statistically significant difference was determined between testing days (n = 8), instrumentation, operators, or reagent batches in precision studies for the methylation-specific assays. The assay performance was unaffected by 9 commonly known interference substances, variations in bisulfite conversion, or quantitative PCR settings (cycling temperatures, incubation times, and oligonucleotide concentrations). For this clinical cohort, sensitivity and specificity estimates for Colvera were 73.1% (19 of 26; 95% CI, 52.2-88.4) and 89.3% (175 of 196; 95% CI, 84.1-93.2), respectively.
CONCLUSION


Colvera is a robust test and suitable for detection of circulating tumor-derived DNA by measuring levels of methylated BCAT1 and IKZF1 in human blood plasma.",2017,"No statistically significant difference was determined between testing days (n = 8), instrumentation, operators, or reagent batches in precision studies for the methylation-specific assays.","['Validation was performed in accordance with ISO15189 and National Pathology Accreditation Advisory Council requirements', 'patients with colorectal cancer', '222 archived plasma samples from subjects (n = 26 with cancer) enrolled in a previous prospective trial', '264 plasma and 120 buffer samples']",[],"['bisulfite conversion, or quantitative PCR settings (cycling temperatures, incubation times, and oligonucleotide concentrations', 'limit of detection for Colvera', 'assay performance']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0063088', 'cui_str': 'hydrogen sulfite'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",26.0,0.152169,"No statistically significant difference was determined between testing days (n = 8), instrumentation, operators, or reagent batches in precision studies for the methylation-specific assays.","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Murray', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Rohan T', 'Initials': 'RT', 'LastName': 'Baker', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Snigdha', 'Initials': 'S', 'LastName': 'Gaur', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Graeme P', 'Initials': 'GP', 'LastName': 'Young', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}]",The journal of applied laboratory medicine,['10.1373/jalm.2017.023135']
1977,32613281,Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma.,"The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (n = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1-4. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade ≥ 3 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413.",2020,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.",['multiple myeloma patients'],"['ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT', 'Ixazomib', 'ixazomib', 'placebo']","['diarrhea', 'rate of grade ≥\u20093 AEs', 'progression-free survival', 'thrombocytopenia', 'rate of discontinuation due to AEs', 'vomiting', 'cumulative, long-term, or late-onset toxicity']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0639010', 'cui_str': '3-(2-aminoethyl)-8-(3-(4-fluorobenzoyl)propyl)-4-oxo-1-phenyl-1,3,8-triazaspiro(4.5)decan-4-one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.566705,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK. Martin.Kaiser@icr.ac.uk.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksaç', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gulbrandsen', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Arriba de la Fuente', 'Affiliation': 'Servicio de Hematología y Oncología Médica, Hospital Universitario Morales Meseguer y Centro Regional de Hemodonación, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca, CIC, IBM CC, Salamanca, Spain.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czorniak', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Annals of hematology,['10.1007/s00277-020-04149-5']
1978,32614141,Targeted Mass Spectrometry of a Clinically Relevant PSA Variant from Post-DRE Urines for Quantitation and Genotype Determination.,"PURPOSE


The rs17632542 single nucleotide polymorphism (SNP) results in lower serum prostate specific antigen (PSA) levels which may further mitigate against its clinical utility as a prostate cancer biomarker. Post-digital rectal exam (post-DRE) urine is a minimally invasive fluid that is currently utilized in prostate cancer diagnosis. To detect and quantitate the variant protein in urine.
EXPERIMENTAL DESIGN


Fifty-three post-DRE urines from rs17632542 genotyped individuals processed and analyzed by liquid chromatography/mass spectrometry (LC-MS) in a double-blinded randomized study. The ability to distinguish between homozygous wild-type, heterozygous, or homozygous variant is examined before unblinding.
RESULTS


Stable-isotope labeled peptides are used in the detection and quantitation of three peptides of interest in each sample using parallel reaction monitoring (PRM). Using these data, groupings are predicted using hierarchical clustering in R. Accuracy of the predictions show 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
CONCLUSIONS AND CLINICAL RELEVANCE


The study demonstrates that MS based peptide variant quantitation in urine could be useful in determining patient genotype expression. This assay provides a tool to evaluate the utility of PSA variant (rs17632542) in parallel with current and forthcoming urine biomarker panels.",2020,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
",['Fifty-three post-DRE urines from rs17632542 genotyped individuals'],[],"['peak detection and area extraction', 'serum PSA levels']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1384593', 'cui_str': 'Digital examination of rectum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}]",,0.0364145,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Otto', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Correll', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Hampus A', 'Initials': 'HA', 'LastName': 'Engstroem', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Naomi L', 'Initials': 'NL', 'LastName': 'Hitefield', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Main', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Albracht', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson-Pais', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Li Fang', 'Initials': 'LF', 'LastName': 'Yang', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liss', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Boutros', 'Affiliation': 'Departments of Human Genetics and Urology, Jonsson Comprehensive Cancer Center, Institute for Precision Health University of California Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kislinger', 'Affiliation': 'University of Toronto, Department of Medical Biophysics, Toronto, ON M5G 1L7, Canada.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Leach', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Semmes', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Julius O', 'Initials': 'JO', 'LastName': 'Nyalwidhe', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}]",Proteomics. Clinical applications,['10.1002/prca.202000012']
1979,32609756,Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.,"BACKGROUND


Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.
METHODS AND FINDINGS


Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.
CONCLUSIONS


ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02776254.",2020,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"['At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC', 'Zambian urban adherence club (AC', '489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female', 'HIV-infected adults in Zambia', '10 clinics were randomized to intervention (5 clinics) or control (5 clinics']",['differentiated service delivery (DSD'],"['rate of late drug pickup', 'median time since ART initiation', 'Median MPR', 'unadjusted Kaplan-Meier survival curves', 'time to first late drug pickup', 'median CD4 count', 'Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",10.0,0.184599,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bolton-Moore', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Izukanji', 'Initials': 'I', 'LastName': 'Sikazwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mpande', 'Initials': 'M', 'LastName': 'Mukumbwa-Mwenechanya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Efronson', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Mwamba', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Somwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kalunkumya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwansa', 'Initials': 'M', 'LastName': 'Lumpa', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Pry', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Wilbroad', 'Initials': 'W', 'LastName': 'Mutale', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'University of California, Berkeley, Berkeley, California, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Topp', 'Affiliation': 'James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Holmes', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003116']
1980,32610254,"Antioxidant cocktail following a high-sodium meal does not affect vascular function in young, healthy adult humans: a randomized controlled crossover trial.","Chronic high sodium intake is a risk factor for cardiovascular disease as it impairs vascular function through an increase in oxidative stress. The objective of this study was to investigate the acute effects of a high-sodium meal (HSM) and antioxidant (AO) cocktail on vascular function. We hypothesized that a HSM would impair endothelial function, and increase arterial stiffness and wave reflection, while ingestion of the AO cocktail would mitigate this response. Healthy adults ingested either an AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM (1500 mg) in a randomized crossover blinded design. Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx) were made at baseline and 30, 60, 90, and 120 min after meal consumption. Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study. Mean BP increased at 120 min relative to 60 min (60 min: 79 ± 1; 120 min: 81 ± 1 mmHg; time effect P = .01) but was not different between treatments (treatment × time interaction P = .32). AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31). PWV (treatment × time interaction, P = .91) and FMD (treatment × time interaction P = .65) were also not different between treatments. In conclusion, a HSM does not acutely impair vascular function suggesting young healthy adults can withstand the acute impact of sodium on the vasculature and therefore, the AO cocktail is not necessary to mitigate the response.",2020,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"['young healthy adults', 'young, healthy adult humans', 'Healthy adults ingested either an', 'Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study']","['Antioxidant cocktail following a high-sodium meal', 'HSM', 'AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM', 'high-sodium meal (HSM) and antioxidant (AO) cocktail']","['endothelial function', 'Mean BP', 'FMD', 'Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx', 'vascular function', 'PWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.120549,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Smiljanec', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ksmilja@udel.edu.'}, {'ForeName': 'Alexis U', 'Initials': 'AU', 'LastName': 'Mbakwe', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ambakwe@udel.edu.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Ramos-Gonzalez', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: macramos@udel.edu.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Biostatistics Core Facility, University of Delaware, STAR, Newark, DE. Electronic address: rpohlig@udel.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: slennon@udel.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.011']
1981,32610257,Oral vitamin C treatment increases polymorphonuclear cell functions in type 2 diabetes mellitus patients with poor glycemic control.,"This study investigated the effect of vitamin C on polymorphonuclear (PMN) cell functions in type 2 diabetes mellitus patients with poor glycemic control. We hypothesized that oral vitamin C treatment improves PMN cell functions. Patients (14) received either a vitamin C (1000 mg/d) or placebo (anhydrous calcium hydrogen phosphate) tablet for 6 weeks and were subjected to a 6-week washout period followed by a 6-week treatment crossover period. Blood samples were collected at pretreatment and posttreatment for PMN cell functions (by flow cytometry) and plasma vitamin C concentration. Phagocytosis was examined by incubating whole blood samples with fluorescein isothiocyanate-labeled Staphylococcus aureus, and oxidative burst was simultaneously evaluated by adding hydroethidine. In comparison with placebo, vitamin C increased both PMN cell phagocytosis (pretreatment: placebo, 17.8% ± 1.6% and vitamin C, 19.0% ± 3.4%, P = .70; posttreatment: placebo, 16.6% ± 1.7% and vitamin C, 27.1% ± 2.9%, P = .005) and oxidative burst (pretreatment: placebo, 6.4% ± 0.8% and vitamin C, 7.1% ± 1.2%, P = .60; posttreatment: placebo, 6.9% ± 1.3% and vitamin C, 12.1% ± 1.6%, P = .02). The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01). Plasma vitamin C concentration and PMN cell functions were not significantly different before both treatments. We conclude that the 6-week 1000-mg/d vitamin C increased PMN phagocytosis and oxidative burst in type 2 diabetes mellitus patients with poor glycemic control.",2020,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,['type 2 diabetes mellitus patients with poor glycemic control'],"['Oral vitamin C treatment', 'placebo, vitamin C', 'oral vitamin C', 'vitamin C', 'placebo (anhydrous calcium hydrogen phosphate) tablet', 'placebo']","['PMN cell functions', 'polymorphonuclear (PMN) cell functions', 'Plasma vitamin C concentration and PMN cell functions', 'Blood samples', 'PMN cell phagocytosis', 'oxidative burst', 'plasma vitamin C concentration', 'polymorphonuclear cell functions', 'PMN phagocytosis and oxidative burst']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0108134', 'cui_str': 'Calcium phosphate dibasic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0085416', 'cui_str': 'Oxidative Burst'}]",,0.155192,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Chuangchot', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: nisachuang@kku.ac.th.'}, {'ForeName': 'Chongchira', 'Initials': 'C', 'LastName': 'Boonthongkaew', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chongchira@kkumail.com.'}, {'ForeName': 'Wisitsak', 'Initials': 'W', 'LastName': 'Phoksawat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: wisitsakphok@kkumail.com.'}, {'ForeName': 'Amonrat', 'Initials': 'A', 'LastName': 'Jumnainsong', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: amonrat@kku.ac.th.'}, {'ForeName': 'Chanvit', 'Initials': 'C', 'LastName': 'Leelayuwat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chanvit@kku.ac.th.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Leelayuwat', 'Affiliation': 'Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: naruemon@kku.ac.th.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.010']
1982,31427720,The impact of complex karyotype on the overall survival of patients with relapsed chronic lymphocytic leukemia treated with idelalisib plus rituximab.,,2020,,['patients with relapsed chronic lymphocytic leukemia treated with'],"['idelalisib plus rituximab', 'complex karyotype']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype determination'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0533494,,"[{'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany. karl-anton.kreuzer@uni-koeln.de.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dubowy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lilienweiss', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Reinhardt', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'University of California-Irvine, Irvine Chao Family Comprehensive Cancer Center, Orange, CA, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-019-0533-6']
1983,32615110,"Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial.","BACKGROUND


The ICON8 study reported no significant improvement in progression-free survival (a primary endpoint) with weekly chemotherapy compared with standard 3-weekly treatment among patients with epithelial ovarian cancer. All ICON8 patients were eligible to take part in the accompanying health-related quality-of-life study, which measured the effect of treatment on self-reported wellbeing, reported here.
METHODS


In this open-label, randomised, controlled, phase 3, three-arm, Gynecologic Cancer Intergroup (GCIG) trial done at 117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were randomly assigned (1:1:1) centrally using minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2  paclitaxel weekly). Randomisation was stratified by GCIG group, disease stage, and outcome and timing of surgery. Patients and clinicians were not masked to treatment assignment. Patients underwent immediate or delayed primary surgery according to clinicians' choice. Patients were asked to complete European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires at enrolment, before each chemotherapy cycle, then 6-weekly up to 9 months, 3-monthly up to 2 years, and 6-monthly up to 5 years. Quality of life was a prespecified secondary outcome of the ICON8 study. Within the quality-of-life study, the co-primary endpoints were QLQ-C30 global health score at 9 months (cross-sectional analysis) and mean QLQ-C30 global health score from randomisation to 9 months (longitudinal analysis). Data analyses were done on an intention-to-treat basis. The trial is registered on ClinicalTrials.gov, NCT01654146 and ISRCTN Registry, ISRCTN10356387, and is currently in long-term follow up.
FINDINGS


Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3). Baseline quality-of-life questionnaires were completed by 1438 (92%) of 1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients. We observed no significant difference in global health score at 9 months (cross-sectional analysis) between study groups (group 2 vs group 1, difference in mean score 2·3, 95% CI -0·4 to 4·9, p=0·095; group 3 vs group 1, -0·8, -3·8 to 2·2, p=0·61). Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
INTERPRETATION


We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after randomisation. Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer.
FUNDING


Cancer Research UK, Medical Research Council, Health Research Board Ireland, Irish Cancer Society, and Cancer Australia.",2020,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
","['1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients', 'newly diagnosed ovarian cancer (ICON8', 'newly diagnosed ovarian cancer', ""Patients underwent immediate or delayed primary surgery according to clinicians' choice"", 'patients with epithelial ovarian cancer', '117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2', 'Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3']","['Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy', 'paclitaxel', 'minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2  intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2  paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2  paclitaxel', 'paclitaxel-containing regimens', 'chemotherapy']","['global quality of life', 'global health scores', 'mean QLQ-C30 global health score', 'progression-free survival', 'Baseline quality-of-life questionnaires', 'mean quality of life', 'global health score', 'Quality of life', 'Cancer QLQ-C30 and QLQ-OV28 questionnaires', 'QLQ-C30 global health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1566.0,0.232117,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018).
","[{'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Blagden', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK. Electronic address: sarah.blagden@oncology.ox.ac.uk.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Department of Oncology, University Hospital Coventry, Coventry, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Howells', 'Affiliation': 'Maggie Keswick Jencks Cancer Caring Centres Trust, London, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'McNeish', 'Affiliation': 'Ovarian Cancer Action Research Centre, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology Department, St John of God Subiaco Hospital, Perth, WA, Australia.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Dearbhaile M', 'Initials': 'DM', 'LastName': ""O'Donnell"", 'Affiliation': 'Gynaecology Subgroup, Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hook', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'James', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Lord', 'Affiliation': 'Department of Oncology, Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Dark', 'Affiliation': 'Department of Oncology, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Earl', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Centre Institute, University College London, London, UK; University College Hospital, London, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; University of Manchester, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30218-7']
1984,32615357,Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.,"BACKGROUND


High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed.
METHODS


The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
CURRENT STATUS


The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018.
CONCLUSION


The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.",2020,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","['Mean age at baseline was 71\u202fyears, and 76% are male', '48 senior residential facilities with 1,606 participants', 'residents in senior residential facilities', 'older adults in China', '48 senior residential facilities in northern China']","['salt substitute and stepwise reduction of salt supply', 'salt intervention', 'stepwise salt supply control (SSSC', 'normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS']","['blood pressure', 'change in systolic blood pressure', 'blood pressure reduction', 'incidence of hyperkalemia, hyponatremia, cardiovascular events, and death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.0400665,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","[{'ForeName': 'Aoming', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Kiang', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Qianku', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lae', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.05.013']
1985,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1986,32615951,Crowdsourcing to promote hepatitis C testing and linkage-to-care in China: a randomized controlled trial protocol.,"BACKGROUND


Hepatitis C virus (HCV) is a growing public health problem with a large disease burden worldwide. In China many people living with HCV are unaware of their hepatitis status and not connected to care and treatment. Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China. This trial aims to evaluate crowdsourcing as a strategy to improve HCV awareness, testing and linkage-to-care in China.
METHODS


A randomized controlled, two-armed trial (RCT) is being conducted in Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital. Eligible participants are ≥30 years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12 months and not known to have chronic HCV; and, having a WeChat social media account. Allocation is 1:1. Both groups will be administered a baseline and a follow-up survey (4-week post-enrollment). The intervention group will receive crowdsourcing materials to promote HCV testing once a week for two weeks and feedback will be collected thereafter, while the control group will receive no promotional materials. Feedback collected will be judged by a panel and selected to be implemented to improve the intervention continuously. Those identified positive for HCV antibodies will be referred to gastroenterologists for confirmation and treatment. The primary outcome will be confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers. Data will be collected on Survey Star @  via mobile devices.
DISCUSSION


This will be the first study to evaluate the impact of crowdsourcing to improve viral hepatitis testing and linkage-to-care in the health facilities. This RCT will contribute to the existing literature on interventions to improve viral hepatitis testing in primary care setting, and inform future strategies to improve HCV care training for primary care providers in China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. ChiCTR1900025771. Registered September 7th, 2019, http://www.chictr.org.cn/showprojen.aspx?proj=42788.",2020,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","['primary care providers in China', 'China', 'Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital', 'Eligible participants are ≥30\u2009years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12\u2009months and not known to have chronic HCV; and, having a WeChat social media account']","['crowdsourcing materials to promote HCV testing', 'control group will receive no promotional materials']","['confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",1006.0,0.0962497,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","[{'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Yang', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China. jingjingli@seshglobal.org.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fitzpatrick', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Polin', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'World Health Organization Western Pacific Regional Office, Manila, Philippines.'}, {'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}]",BMC public health,['10.1186/s12889-020-09152-z']
1987,32615994,Inhaled granulocyte-macrophage colony stimulating factor for mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24 months of follow-up.,"BACKGROUND


Treatment of autoimmune pulmonary alveolar proteinosis (aPAP) by inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) is considered safe and effective. Evidence of benefit from GM-CSG inhalation for mild to moderate aPAP patients is limited.
METHODS


In this multicenter, randomized, open-labeled clinical trial, 36 aPAP patients with mild to moderate disease severity were randomized into either the GM-CSF treatment group or control group. Inhaled GM-CSF was prescribed for 6 months, and patients received follow-up for another 18 months without treatment. Physiological features of the patients were analyzed.
RESULTS


There were 36 patients (19 in the treatment group, 17 in the control group) included. There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]). Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC%), however, were significantly improved in the treatment group by the end of the study (P = 0.010 and 0.027). St. George Respiratory questionnaire (SGRQ) scores were better after 6 months treatment with GM-CSF compared to the control group, and the benefits of treatment were maintained throughout the observation period. No severe side effects were observed during the study.
CONCLUSION


Six months of inhaled GM-CSF treatment had no effect on the alveolar-arterial oxygen gradient in patients with mild to moderate pulmonary alveolar proteinosis. There were changes in some clinical or laboratory measures, but no clinically important changes were noted at the end of study. (Clinical Trial Registry: NCT02243228, Registered on September 17, 2014, https://www.clinicaltrials.gov/ct2/show/NCT02243228?term=NCT02243228&draw=2&rank=1 ).",2020,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","['36 patients (19 in the treatment group, 17 in the control group) included', 'patients with mild to moderate pulmonary alveolar proteinosis', '36 aPAP patients with mild to moderate disease severity', 'mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24\u2009months of follow-up', 'mild to moderate aPAP patients']","['inhaled GM-CSF', 'Inhaled granulocyte-macrophage colony stimulating factor', 'GM-CSG inhalation', 'inhaled granulocyte-macrophage colony stimulating factor (GM-CSF', 'GM-CSF treatment group or control group', 'Inhaled GM-CSF']","['alveolar-arterial oxygen gradient', 'Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC', 'change of alveolar arterial oxygen gradient', 'St. George Respiratory questionnaire (SGRQ) scores', 'severe side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0034050', 'cui_str': 'Pulmonary alveolar proteinosis'}, {'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",36.0,0.0306328,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","[{'ForeName': 'Xinlun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenshuai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingshan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yusen', 'Initials': 'Y', 'LastName': 'Situ', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yonglong', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China. yonglongxiao@sina.cn.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. xukf@pumch.cn.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01450-4']
1988,32616003,Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study.,"BACKGROUND


Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®).
METHODS


This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or ""TightRope®""). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.
DISCUSSION


The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS) DRKS00013562 . Registered on July, 12, 2017.",2020,"A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis).","['Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg', 'acute syndesmosis rupture', 'Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center']","['static implant (a 3.5\u2009mm metallic screw) or a dynamic device (TightRope®', 'treatment options (screw fixation or ""TightRope®', 'TightRope® or screw fixation']",['successful healing of the syndesmosis and biomechanical investigation with gait analysis'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0555346', 'cui_str': 'Fracture of lateral malleolus'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C2863797', 'cui_str': 'Maisonneuve fracture'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",,0.0619142,"A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany. julian.doll@med.uni-heidelberg.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Waizenegger', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, D-69118, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Sebastian I', 'Initials': 'SI', 'LastName': 'Wolf', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04550-5']
1989,32616017,Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.,"BACKGROUND


Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications.
METHODS


This is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done.
DISCUSSION


This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.",2020,Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique.,"['274 subjects', 'elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures']","['non-emergent midline laparotomy for general surgery or vascular procedure', 'fascia closure technique']",['incisional hernia'],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]",,0.452634,Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique.,"[{'ForeName': 'Mohamad Hadi', 'Initials': 'MH', 'LastName': 'El Charif', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Hassan', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hoballah', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Khalife', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Sbaity', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon. es25@aub.edu.lb.'}]",Trials,['10.1186/s13063-020-04507-8']
1990,32631211,Perceived male partner attitudes toward the female condom predict female university students' use of the female condom.,"Female and male condoms are the only methods that prevent both sexually transmitted infections (STIs), including HIV, and unintended pregnancy. Despite continuing high STI rates, few studies investigate factors predicting whether women initiating female condom (FC) use sustain use. Using data from a randomized trial, we examined predictors of sustained FC use at five-month follow-up (FU2) among female university students in South Africa who participated in either a one-session, information-only, group-delivered  Minimal Intervention  or a two-session, group-delivered  Enhanced Intervention . In the final multiple logistic regression model, believing one's partner holds positive attitudes toward the FC (aOR = 1.40; p = 0.028), and greater FC use for vaginal sex at previous assessment (aOR) = 1.19; p = 0.008) were associated with greater odds of FC use at FU2. Excluding number of FC-protected occasions at FU1 from the analysis, discussing FC use with partner (aOR = 2.89; p = 0.071) and believing one's partner holds positive attitudes toward the FC (aOR = 1.63; p < 0.001) were associated with greater odds of use at FU2. The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device. Engaging men as FC champions to support and promote FC use, along with marketing campaigns targeted to men, may expand FC coverage and enhance uptake.",2020,"The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device.","[""Perceived male partner attitudes toward the female condom predict female university students' use of the female condom"", 'female university students in South Africa who participated in either a one-session, information-only, group-delivered', 'Female and male condoms']","['sustained FC use at five-month follow-up (FU2', 'Minimal Intervention  or a two-session, group-delivered  Enhanced Intervention ']",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],1.0,0.0216513,"The FC empowers women to protect themselves from both STIs and unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device.","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Mantell', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Exner', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bai', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Zonke', 'Initials': 'Z', 'LastName': 'Mabude', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry, Division of Gender, Sexuality and HIV, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smit', 'Affiliation': 'MRU (MatCH Research Unit), Department of Obstetrics & Gynaecology, The University of the Witwatersrand, Durban, South Africa.'}]",International journal of STD & AIDS,['10.1177/0956462420912986']
1991,32631243,Effects of a work stress intervention on healthcare use and treatment compared to treatment as usual: a randomised controlled trial in Swedish primary healthcare.,"BACKGROUND


Work stress is an increasing burden in society. Identifying early symptoms of work stress in primary healthcare (PHC) could result in earlier and better-targeted care. The Work Stress Questionnaire (WSQ) was developed in PHC for this task. We aimed to evaluate whether the use of the WSQ, in combination with physicians' feedback, resulted in differences in healthcare visits and treatment compared to treatment as usual (TAU) in patients reporting high stress. Our hypothesis was that patients receiving the intervention would generate more visits to rehabilitation providers during follow-up compared to TAU.
METHODS


A two-armed randomised controlled trial was conducted at seven primary healthcare centres (PHCCs) in Region Västra Götaland, Sweden. One group received the WSQ intervention, and the controls received TAU. Employed, not sick-listed persons aged 18-64 years who sought care for mental or physical health complaints at the PHCCs participated. Register data on healthcare visits and treatments 12 months prior to inclusion and 12 months after were obtained and analysed with Fisher's exact test together with questionnaire data (WSQ and background features).
RESULTS


A total of 271 participants were included in the study, 132 intervention and 139 controls. Visits to psychologists/psychotherapists were higher among intervention participants with high stress (20%, n = 87) during follow-up compared to corresponding controls (7%, n = 97) (p < 0.05). Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05). The amount of received cognitive behavioural therapy (CBT) was higher among the stressed intervention group (16%) than among controls (10%) during follow-up.
CONCLUSIONS


The intervention group that used the WSQ with physicians' feedback had an increased number of rehabilitative measures and treatment more in line with established guidelines compared to treatment as usual. Findings of the study indicate that the WSQ can assist in identifying work stress in primary healthcare and contribute to physicians' recommendations of suitable rehabilitative measures at an earlier stage compared to treatment as usual.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier: NCT02480855 . Registered 20 May 2015.",2020,Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05).,"['sick-listed persons aged 18-64\u2009years who sought care for mental or physical health complaints at the PHCCs participated', 'patients reporting high stress', 'A two-armed randomised controlled trial was conducted at seven primary healthcare centres (PHCCs) in Region Västra Götaland, Sweden', 'Swedish primary healthcare', 'A total of 271 participants were included in the study, 132 intervention and 139 controls']","['WSQ intervention, and the controls received TAU', 'work stress intervention', 'WSQ', 'cognitive behavioural therapy (CBT', ""WSQ with physicians' feedback""]","['Work Stress Questionnaire (WSQ', 'number of rehabilitative measures']","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",271.0,0.106091,Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05).,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sandheimer', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Christine.sandheimer@gu.se.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Hedenrud', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Hensing', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Holmgren', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMC family practice,['10.1186/s12875-020-01210-0']
1992,32631261,Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial.,"BACKGROUND


A high number of patients with obsessive-compulsive disorder (OCD) do not receive cognitive-behavioral therapy with exposure and response prevention, which is the most effective treatment for OCD. Therefore, Metacognitive Training for OCD (MCT-OCD) was developed, which is a structured group therapy aiming at the modification of dysfunctional (meta-)cognitive biases, beliefs and coping styles. It can be administered by less trained personnel, thus may reach a higher number of patients. An uncontrolled pilot study (MCT-OCD pilot version) provided first evidence that the training is highly accepted by patients; OC symptoms decreased with a high effect size (η 2 partial  = 0.50). The aim of the present study is to address the shortcomings of the pilot study (e.g., no control group) and to assess the efficacy of the revised version of the MCT-OCD in the framework of a randomized controlled trial.
METHODS


Eighty patients with OCD will be recruited. After a blinded assessment at baseline (-t1), patients will be randomly assigned either to the intervention group (MCT-OCD; n = 40) or to a care as usual control group (n = 40). The MCT-OCD aims to enhance patients' metacognitive competence in eight modules by addressing dysfunctional (meta-)cognitive biases and beliefs associated with OCD (e.g., intolerance of uncertainty). After 8 weeks, patients will be invited to a post assessment (t1), and then they will receive a follow-up online questionnaire 3 months following t1 (t2). The primary outcome is the Y-BOCS total score, and the secondary outcomes include the HDRS, OCI-R, OBQ-44, MCQ-30, WHOQOL-BREF, BDI-II, and subjective appraisal ratings of the MCT-OCD. We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
DISCUSSION


The planned study is the first to investigate the MCT-OCD, a promising new treatment, in a randomized controlled trial. The MCT-OCD may help to overcome existing treatment barriers for patients with OCD.
TRIAL REGISTRATION


German Registry for Clinical Studies ( DRKS00013539 ), 22.02.2018.",2020,"We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
","['patients with OCD', 'Eighty patients with OCD will be recruited', 'patients with obsessive-compulsive disorder (OCD', 'Obsessive-Compulsive Disorder']","['intervention group (MCT-OCD; n\u2009=\u200940) or to a care as usual\xa0control group', 'MCT-OCD', 'Metacognitive Training for OCD (MCT-OCD', 'Metacognitive Training']","['Y-BOCS total score', 'HDRS, OCI-R, OBQ-44, MCQ-30, WHOQOL-BREF, BDI-II, and subjective appraisal ratings of the MCT-OCD', 'OC symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0684043', 'cui_str': 'Occitan language'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.0874827,"We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Miegel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. f.miegel@uke.de.'}, {'ForeName': 'Cüneyt', 'Initials': 'C', 'LastName': 'Demiralay', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02648-3']
1993,32631301,"The clinical effect of dexmedetomidine combined with parecoxib sodium on sedation, antianxiety and prevention of intubation stress in patients undergoing functional endoscopic sinus surgery: a randomised controlled trial.","BACKGROUND


To investigate the effect of intravenous injection of dexmedetomidine combined with parecoxib sodium on sedation and anxiety and stress response of tracheal intubation in patients undergoing functional endoscopic sinus surgery.
METHODS


One hundred twenty patients undergoing endoscopic sinus surgery were randomly divided into four groups: group DP, group D, group P and group N. The blood pressure (BP), heart rate (HR), blood oxygen saturation (SPO2), EEG, bispectral index (BIS), Ramsay sedation score and state anxiety questionnaire (SAI) were recorded before administration (T0), 10 min (T1), 20 min (T2) and 30 min (T3) after administration. After 30 min, endotracheal intubation was performed after anesthesia induction. The BP, HR, SPO2 were recorded 1 min before intubation (T4), intubation (T5), 3 min (T6) after intubation, 5 min (T7) after intubation, and blood samples were collected from patients before administration and after intubation 2 min to detect serum cortisol (Cor), adrenalin (E) norepinephrine (NE) and blood glucose (BS).
RESULTS


There was no significant difference in Ramsay sedation score before anesthesia, but the Ramsay sedation score in group D、DP was significantly higher than that in group P and group N, the BIS, BP, HR and anxiety scores were significantly lower than those in the group P and group N (p < 0.05). There was no significant difference in Ramsay sedation score, BIS value, anxiety score and BP, HR between group D and group DP (p > 0.05). Compared with T4, there was no significant difference in BIS and BP, HR in group D, group DP and group P (p > 0.05), but the BIS, BP and HR in group N were significantly higher than T4, (p < 0.05). Three minutes after intubation there was no statistical difference in the changes of Cor, E, NE and BS values compared with before intubation in group P and group DP (p > 0.05), but the changes of Cor, E, NE and BS values were significantly lower than that in group N (p < 0.05). Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05). while the NE, E, Cor, BS of T6 are at the same level as the base value. In group N, the NE, E, Cor, BS of T4 were at the same level of T0, but significantly higher at T6.And at T6, NE and E in group D, P and N were significantly different from those in group DP (p < 0.05).
CONCLUSION


Preoperative intravenous infusion of dexmedetomidine combined with parecoxib sodium by functional nasal endoscopy can not only calm and resist anxiety, but also better prevent stress response of endotracheal intubation, which is a safe and effective way of preoperative medication.
TRIAL REGISTRATION


ChiCTR-OPN-17010444 . Prospectively registered on 16 January 2017.",2020,"Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05).","['Prospectively registered on 16 January 2017', 'patients undergoing functional endoscopic sinus surgery', 'One hundred twenty patients undergoing endoscopic sinus surgery']","['endotracheal intubation', 'dexmedetomidine', 'parecoxib sodium']","['BIS and BP, HR', 'BIS, BP and HR', 'sedation, antianxiety and prevention of intubation stress', 'Ramsay sedation score, BIS value, anxiety score and BP, HR', 'BIS, BP, HR and anxiety scores', 'serum cortisol (Cor), adrenalin (E) norepinephrine (NE) and blood glucose (BS', 'sedation and anxiety and stress response', 'values of NE, E, Cor, BS', 'BP, HR, SPO2', 'changes of Cor, E, NE and BS values', 'blood pressure (BP), heart rate (HR), blood oxygen saturation (SPO2), EEG, bispectral index (BIS), Ramsay sedation score and state anxiety questionnaire (SAI', 'Ramsay sedation score']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0915144', 'cui_str': 'Parecoxib sodium'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.034208,"Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05).","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Jinan University, No. 601 West Huangpu Avenue, Tianhe District, Guangzhou City, 510632, Guangdong Province, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Jinxian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Liangqing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China. gu7450210@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01080-0']
1994,32631388,"A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes.","BACKGROUND


Allium hookeri is widely consumed as a vegetable and herbal medicine in Asia. A. hookeri has been reported anti-inflammatory, anti-obesity, osteoblastic, anti-oxidant, and anti-diabetic effects in animal studies. We investigated the anti-diabetic effects of A. hookeri aqueous extract (AHE) in the Korean subjects.
METHODS


Prediabetic subjects (100 ≤ fasting plasma glucose (FPG) < 126 mg/dL) who met the inclusion criteria were recruited for this study. The enrolled subjects (n = 30) were randomly divided into either an AHE (n = 15, 486 mg/day) or placebo (n = 15) group. Outcomes were measurements of FPG, glycemic response to an oral glucose tolerance test (OGTT), insulin, C-peptide, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol. The t-test was used to assess differences between the groups. A p-value < 0.05 was considered statistically significant.
RESULTS


Eight weeks after AHE supplementation, HbA1c level was significantly decreased in the AHE group compared with the placebo group. No clinically significant changes in any safety parameter were observed.
CONCLUSION


The findings suggest that AHE can be effective in reducing HbA1c, indicating it as an adjunctive tool for improving glycemic control.
TRIAL REGISTRATION


The study protocol was retrospectively registered at www.clinicaltrials.gov ( NCT03330366 , October 30, 2017).",2020,"No clinically significant changes in any safety parameter were observed.
","['subjects with prediabetes', 'Korean subjects', 'Prediabetic subjects (100\u2009≤\u2009fasting plasma glucose (FPG)\u2009<\u2009126\u2009mg/dL) who met the inclusion criteria were recruited for this study', 'enrolled subjects (n\u2009=\u200930']","['Allium hookeri extract', 'hookeri aqueous extract (AHE', 'AHE', 'AHE supplementation', 'placebo']","['safety parameter', 'HbA1c level', 'FPG, glycemic response to an oral glucose tolerance test (OGTT), insulin, C-peptide, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002125', 'cui_str': 'Allium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.274407,"No clinically significant changes in any safety parameter were observed.
","[{'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Ui-Jin', 'Initials': 'UJ', 'LastName': 'Bae', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Agro-food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Republic of Korea.'}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Center for Healthcare Technology Development, Chonbuk National University, Jeonju, Republic of Korea.'}, {'ForeName': 'You-Suk', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Goldtree Co., Ltd., Sunchang, Republic of Korea.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Jeong', 'Affiliation': 'Microbial Institute for Fermentation Industry, Sunchang, Republic of Korea.'}, {'ForeName': 'Hyun-Ju', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Department, World Institute of Kimchi, Gwangju, Republic of Korea.'}, {'ForeName': 'Byung-Hyun', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea. swchae@jbctc.org.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03005-3']
1995,32631400,Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial.,"BACKGROUND


Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).
METHODS


Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.
DISCUSSION


This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019.",2020,"This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).
","['Older adults with chronic MSP', 'older emergency department patients with acute musculoskeletal pain', 'Three hundred sixty patients from the ED', 'older adults in the emergency department (ED', 'adults aged 50\u2009years and older']","[""full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72\u2009h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care"", 'Brief educational video plus telecare']","['physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention', 'composite measure of pain severity and interference']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",360.0,0.202317,"This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).
","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Platts-Mills', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina at Chapel Hill, Houpt Bldg, 170 Manning Dr, Chapel Hill, NC, 27599, USA. tim_platts-mills@med.unc.edu.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'Department of Anesthesiology, University of North Carolina Hospitals, Chapel Hill, NC, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sally C', 'Initials': 'SC', 'LastName': 'Stearns', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Montika', 'Initials': 'M', 'LastName': 'Bush', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina at Chapel Hill, Houpt Bldg, 170 Manning Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Brittni B', 'Initials': 'BB', 'LastName': 'Teresi', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina at Chapel Hill, Houpt Bldg, 170 Manning Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hurka-Richardson', 'Affiliation': 'Department of Emergency Medicine, University of North Carolina at Chapel Hill, Houpt Bldg, 170 Manning Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Regenstrief Institute and Department of Medicine, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kerns', 'Affiliation': 'School of Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}]",Trials,['10.1186/s13063-020-04552-3']
1996,32631401,The impacts of multiple obesity-related interventions on quality of life in children and adolescents: a randomized controlled trial.,"BACKGROUND AND PURPOSE


Obesity has become a serious public health problem and family- and school-based interventions including physical exercise and diet control have been widely applied to attempt to combat this issue. The purpose of our study was to verify the effectiveness of an obesity-related comprehensive intervention model aimed at improving quality of life (QoL) among adolescents.
METHODS


A cluster randomized controlled trial (RCT) was conducted involving 948 subjects who were divided into an intervention group (n = 518) and a control group (n = 430). The intervention group received 1 year of obesity-related health education, physical exercise, and diet control. Their baseline body mass index (BMI) was calculated, and their QoL and basic information were assessed both before and after the intervention period using a self-designed Adolescent Quality of Life Scale and a basic information questionnaire.
RESULTS


After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group. Improved psychological QoL in the intervention group was our most robust study finding, with increases in psychological (B = 1.883, SE = 0.646, P = 0.004), pubertal (B = 0.853, SE = 0.296, P = 0.004) and total (B = 3.024, SE = 1.214, P = 0.013) QoL all being higher in this group. This intervention effect was found to be more substantial in boys than in girls.
CONCLUSIONS


Family-individual-school-based interventions combining obesity-related health education, physical exercise, and diet control can improve psychological, pubertal, and total QoL in children, with these effects being most pronounced in boys.
TRIAL REGISTRATION


retrospectively registered NCT02343588 .",2020,"After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group.","['adolescents', '948 subjects who were divided into an intervention group (n\u2009=\u2009518) and a control group (n\u2009=\u2009430', 'children and adolescents']","['multiple obesity-related interventions', '1 year of obesity-related health education, physical exercise, and diet control']","['quality of life', 'psychological QoL', 'quality of life (QoL', 'baseline body mass index (BMI', 'psychological', 'psychological, social, and pubertal dimensions, and in total QoL']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",948.0,0.0333573,"After the intervention, significant differences in the psychological, social, and pubertal dimensions, and in total QoL (P < 0.05) were observed in the intervention group relative to the control group.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Diao', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China. wangh111111@aliyun.com.'}, {'ForeName': 'Lianjian', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Research Center for Medicine and Social Development, Collaborative Innovation Center of Social Risks Governance in Health, Chongqing Medical University, Chongqing, China.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01459-0']
1997,32631405,"Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


This study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19.
TRIAL DESIGN


This study is a randomized, single-blinded, two-arm (1:1 ratio) parallel group clinical trial.
PARTICIPANTS


We are conducting this study in patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran. The inclusion criteria are as follows: (1) aged between 20 and 60 years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities. The exclusion criteria are as follows: (1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month.
INTERVENTION AND COMPARATOR


Duration of intervention: 7 days from randomization Intervention in the treatment group: Vitamin A 25,000 IU daily Vitamin D 600,000 IU once during study Vitamin E 300 IU twice daily Vitamin C is taken four times per day B vitamins are taken as a daily Soluvit [which included thiamine nitrate 3.1 mg, sodium riboflavin phosphate 4.9 mg (corresponding to vitamin B 2  3.6 mg), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to vitamin B 6  4.0 mg), sodium pantothenate 16.5 mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113 mg (corresponding to vitamin C 100 mg), biotin 60 μg, folic acid 400 μg, and cyanocobalamin 5 μg] The control group will not receive any supplements or placebo. All supplements are made in Iran except for Soluvit (from Fresenius Kabi, New Zealand).
MAIN OUTCOMES


1. Weight, height, and BMI 2. Severity of pulmonary involvement according to CT scan 3. Respiratory support (invasive or non-invasive) 4. Percentage of oxygen saturation (SpO2 level) 5. Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6. The patient's body temperature 7. The presence or absence of involvement of organs other than the lungs (e.g., heart, liver, kidneys) 8. Duration of hospitalization 9. Mortality rate RANDOMIZATION: At baseline, eligible patients were randomly assigned to a 1:1 ratio to one of two groups: intervention and control. Block randomization is used based on the gender of patients.
BLINDING (MASKING)


Patients are unaware of being placed in the intervention or control groups after signing consent. All treatment staff will be aware of which group each of the patients is in due to the specific conditions of the ICU and the absence of placebo for the control group.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


The researchers plan to include 60 patients in total, with 30 patients in each group.
TRIAL STATUS


This is the first version of the protocol which started on April 2, 2020. Recruitment began April 2, 2020, and is expected to be complete by July 4, 2020.
TRIAL REGISTRATION


The Iranian Registry of Clinical Trials IRCT20200319046819N1 . Registered on April 4, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol (Fig. 1, Table 1).",2020,"Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6.","['The inclusion criteria are as follows: (1) aged between 20 and 60\u2009years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities', 'ICU patients with COVID-19', 'patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran', '60 patients in total, with 30 patients in each group', '\n\n\nPatients are unaware of being placed in the intervention or control groups after signing consent', 'ICU patients with coronavirus-19', '1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month']","['vitamins A, B, C, D, and E supplementation', 'placebo', 'thiamine nitrate 3.1\u2009mg, sodium riboflavin phosphate 4.9\u2009mg (corresponding to vitamin B 2  3.6\u2009mg), nicotinamide 40\u2009mg, pyridoxine hydrochloride 4.9\u2009mg (corresponding to vitamin B 6  4.0\u2009mg), sodium pantothenate 16.5\u2009mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113\u2009mg (corresponding to vitamin C 100\u2009mg), biotin 60\u2009μg, folic acid 400\u2009μg, and cyanocobalamin 5\u2009μg']","['Weight, height, and BMI 2', 'Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6', 'severity and mortality rate', 'Percentage of oxygen saturation (SpO2 level', 'improvement and mortality rate']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039844', 'cui_str': 'Thiamine mononitrate'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0037548', 'cui_str': 'Riboflavin sodium phosphate'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0700496', 'cui_str': 'Pyridoxine hydrochloride'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0772245', 'cui_str': 'Sodium pantothenate'}, {'cui': 'C0030342', 'cui_str': 'Pantothenic Acid'}, {'cui': 'C0887557', 'cui_str': 'Sodium Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.202892,"Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6.","[{'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sama', 'Initials': 'S', 'LastName': 'Bitarafan', 'Affiliation': 'Iranian Center of Neurological Research (ICNR), Neuroscience Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, 1419733141, Iran. bitarafans@gmail.com.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Hoseindokht', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Pathology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Amoozadeh', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Mahmoodi Ali Abadi', 'Affiliation': 'Department of Laboratory, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Foroumandi', 'Affiliation': 'Anaesthesiology and Intensive Care Department, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04547-0']
1998,32631413,Registration of phase 3 crossover trials on ClinicalTrials.gov.,"BACKGROUND


In a randomized crossover trial, each participant is randomized to a sequence of treatments and treatment effect is estimated based on within-individual difference because each participant serves as his/her own control. This feature makes the design and reporting of randomized crossover trials different from that of parallel trials. Our objective was to characterize phase 3 crossover trials with results reported on ClinicalTrials.gov and identify issues and best practices for reporting.
METHODS


We searched ClinicalTrials.gov for phase 3 randomized crossover trials that provided results, registered at least one primary outcome, and included at least one link to a results publication in the record by August 6, 2019. Two reviewers independently assessed the eligibility and extracted information from each record into an electronic form developed and maintained in the Systematic Review Data Repository.
RESULTS


Of the 124 crossover trials analyzed, two thirds were a simple ""Intervention A then B"" or ""Intervention B then A"" (AB|BA) design. Most trials (78%, 97/124) provided enough information to understand the participant flow throughout the trial. Baseline characteristics were most often reported for all participants as a single group (52%, 65/124). Primary outcomes and adverse events were most commonly reported ""per intervention"" (85%, 105/124, and 80%, 99/124, respectively).
CONCLUSIONS


The registration and reporting of randomized crossover trials must account for the paired nature of the design. Our observations and recommendations informed the development of guidelines for good reporting practices in the registration and reporting of randomized crossover trials.",2020,"Primary outcomes and adverse events were most commonly reported ""per intervention"" (85%, 105/124, and 80%, 99/124, respectively).
",[],[],['adverse events'],[],[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.501121,"Primary outcomes and adverse events were most commonly reported ""per intervention"" (85%, 105/124, and 80%, 99/124, respectively).
","[{'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Statistics Collaborative, Inc, Washington, D. C., USA.'}, {'ForeName': 'Riaz', 'Initials': 'R', 'LastName': 'Qureshi', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Heath, Baltimore, MD, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'IQVIA, Parsippany, NJ, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Drye', 'Affiliation': 'Blue Cross Blue Shield Association, Chicago, IL, USA.'}, {'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Colorado Denver, Aurora, CO, USA. tianjing.li@cuanschutz.edu.'}]",Trials,['10.1186/s13063-020-04545-2']
1999,32631586,A randomized trial on the effect of oral combined estradiol and drospirenone on glucose and insulin metabolism in healthy menopausal women with a normal oral glucose tolerance test.,"BACKGROUND


Menopause is often associated with a central accumulation of body fat. This provokes insulin resistance. The resulting hyperinsulinemia may increase the risk of diabetes, cardiovascular disease and breast cancer. Long-term studies indicate that menopausal hormone therapy (MHT) reduces insulin resistance. To broaden knowledge of the mechanisms behind the influence of MHT on glucose homeostasis we focused on the direct short-term effects of MHT with oral combined estradiol and drospirenone on glucose and insulin metabolism in healthy postmenopausal women.
METHODS


This randomized, placebo-controlled study recruited 80 healthy postmenopausal women. Women were randomized to treatment with estradiol 1 mg continuously combined with drospirenone 2 mg or placebo for 6-8 weeks. All participants underwent an oral glucose tolerance test (OGTT) before and after the treatment period. Glucose, insulin, fructosamine and C-peptide levels were measured in serum before and 30, 60, 90, 120 and 150 min after a 75-gram oral glucose challenge.
RESULTS


After intervention, significantly higher glucose levels at 120 min (p < 0.024) and 150 min (p < 0.030) were observed in the MHT group compared with the placebo group. These glucose levels remained within the normal range. A significantly lower insulin peak serum level (p < 0.040) and a non-significantly smaller area under the curve (AUC) for insulin levels (p = 0.192) was observed in the MHT group at the end of the study period relative to baseline. No significant change in the insulin AUC in the placebo group was observed. There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
CONCLUSION


This double-blind randomized study (EC/2008/694) indicates that treating healthy, postmenopausal women with 1 mg estradiol continuously combined with 2 mg drospirenone significantly decreases peak insulin levels and increases peak glucose levels during an OGTT compared to placebo. These glucose levels remained within the normal range.",2020,"There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
","['healthy, postmenopausal women with 1\u202fmg estradiol continuously combined with 2\u202fmg', 'healthy menopausal women with a normal oral glucose tolerance test', 'healthy postmenopausal women', '80 healthy postmenopausal women']","['estradiol 1\u202fmg continuously combined with drospirenone 2\u202fmg or placebo', 'estradiol and drospirenone', 'oral glucose tolerance test (OGTT', 'drospirenone', 'menopausal hormone therapy (MHT', 'oral combined estradiol and drospirenone', 'placebo']","['Glucose, insulin, fructosamine and C-peptide levels', 'insulin peak serum level', 'risk of diabetes, cardiovascular disease and breast cancer', 'peak glucose levels', 'higher glucose levels', 'peak insulin levels', 'glucose levels', 'smaller area under the curve (AUC) for insulin levels', 'insulin AUC', 'fructosamine, HOMA-IR and C-peptide levels', 'glucose and insulin metabolism']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0985841', 'cui_str': 'Estradiol 1 MG'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1670781', 'cui_str': 'drospirenone 2 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",80.0,0.368072,"There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium. Electronic address: herman.depypere@ugent.be.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dierickx', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vandevelde', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Stanczyk', 'Affiliation': 'Departments of Obstetrics and Gynecology, and Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ottoy', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delanghe', 'Affiliation': 'Department Clinical Chemistry, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.'}]",Maturitas,['10.1016/j.maturitas.2020.04.009']
2000,32631651,A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors.,"PURPOSE


The purpose of this study was to evaluate the use of a semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles in three-dimensional (3D) transvaginal ultrasound (TVUS) images, with the aim of providing a clinically useful tool for intraoperative implant assessment.
METHODS AND MATERIALS


A needle segmentation algorithm previously developed for HDR prostate brachytherapy was adapted and extended to 3D TVUS images from gynecologic ISBT patients with vaginal tumors. Two patients were used for refining/validating the modified algorithm and five patients (8-12 needles/patient) were reserved as an unseen test data set. The images were filtered to enhance needle edges, using intensity peaks to generate feature points, and leveraged the randomized 3D Hough transform to identify candidate needle trajectories. Algorithmic segmentations were compared against manual segmentations and calculated dwell positions were evaluated.
RESULTS


All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm. The median distance between corresponding dwell positions was 0.77 mm with 86% of needles having maximum differences <3 mm. The mean segmentation time using the algorithm was <30 s/patient.
CONCLUSIONS


We successfully segmented multiple needles simultaneously in intraoperative 3D TVUS images from gynecologic HDR-ISBT patients with vaginal tumors and demonstrated the robustness of the algorithmic approach to image artifacts. This method provided accurate segmentations within a clinically efficient timeframe, providing the potential to be translated into intraoperative clinical use for implant assessment.",2020,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"['gynecologic HDR-ISBT patients with vaginal tumors', 'vaginal tumors', 'gynecologic ISBT patients with vaginal tumors']",['semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles'],"['median distance', 'mean segmentation time']","[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042258', 'cui_str': 'Neoplasm of vagina'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.027857,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"[{'ForeName': 'Jessica Robin', 'Initials': 'JR', 'LastName': 'Rodgers', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada. Electronic address: jrodge23@uwo.ca.'}, {'ForeName': 'William Thomas', 'Initials': 'WT', 'LastName': 'Hrinivich', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Surry', 'Affiliation': 'Department of Medical Physics, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Velker', 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fenster', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada.'}]",Brachytherapy,['10.1016/j.brachy.2020.05.006']
2001,32631710,A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study.,"INTRODUCTION


The non-radioactive method that uses the magnetic tracer (SPIO/Sienna) has shown to be a feasible technique for the SLN detection in breast cancer patients. The aim of this study is to assess the efficacy of different doses of a new magnetic tracer Sienna XP (Magtrace) compared to Tc-99 m and to evaluate its non-inferiority.
METHODS


Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible and consecutively randomized to three different doses of new SPIO used: group 1 (1 mL), group 2 (1.5 mL) and group 3 (2 mL).
RESULTS


A total of 135 patients were included in the study, 45 in each group. Detection of SLNs with the three doses of Sienna XP (1 mL, 1.5 mL and 2 mL) showed non-inferior rates compared to the conventional technique with radiotracer (p = 0.654). Concordance by patients with SLN positive was 100% for all groups. 83 (70.3%) patients reported skin staining at one month postoperatively, significantly lower in group 1 (p = 0.042). At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01). In multivariate analysis, dose of 2 mL showed statistically significant for the skin staining. The majority of patients (70%) felt that skin discoloration does not represent a problem.
CONCLUSION


The use of the Sienna XP magnetic tracer at 1 mL is not inferior to higher doses of magnetic tracer neither is inferior to radiotracer. 1 mL of magnetic tracer resulted in significantly less skin discoloration compared to higher doses.",2020,"At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01).","['breast cancer patients', 'sentinel lymph node biopsy in breast cancer', 'A total of 135 patients were included in the study, 45 in each group', 'Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible']","['new magnetic tracer Sienna XP (Magtrace', 'superparamagnetic iron oxide tracer']","['skin staining', 'non-inferior rates', 'skin discoloration']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0246249', 'cui_str': 'ferumoxides'}]","[{'cui': 'C0423765', 'cui_str': 'Staining of skin'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}]",135.0,0.0842373,"At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01).","[{'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain. Electronic address: irubior@unav.es.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodriguez-Revuelto', 'Affiliation': 'Breast Center, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Espinosa-Bravo', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Siso', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Rivero', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Esgueva', 'Affiliation': 'Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.06.018']
2002,32631713,A randomized controlled trial of minor hand surgeries comparing wide awake local anesthesia no tourniquet and local anesthesia with tourniquet.,"INTRODUCTION


Epinephrine and sodium bicarbonate (NaHCO 3 ) used in wide-awake local anesthesia no tourniquet (WALANT) affect many areas such as hemostasis, injection pain, anesthetic effect and others. However, few clinical trials have focused on injection pain and the duration of anesthetic effect, and no prospective studies have reported the benefits of WALANT post operation. This study compared WALANT with conventional local anesthesia with tourniquet in minor hand surgeries, and aimed to answer following questions: (1) Does WALANT have enough benefits for injection pain and duration of anesthetic effect?; (2) How does WALANT affect postoperative management (such as postoperative pain and use of analgesics)?; (3) How satisfied are the patients with the surgery?
HYPOTHESIS


We hypothesized that WALANT had advantages in injection pain, duration of anesthetic effect, and postoperative management compared to conventional local anesthesia.
MATERIALS AND METHODS


The present study is designed as a randomized prospective one center study. This study included 185 patients who received surgical treatment for the diagnosis of carpal tunnel syndrome, trigger finger, or de Quervain's disease between 2017 and 2019. We randomly allocated the patients to either the WALANT group or the conventional group. We inquired and recorded patients' injection pain, duration of anesthetic effect, postoperative pain, the use of analgesics, and satisfaction with the surgery.
RESULTS


The injection pain was significantly lower in the WALANT group in all procedures (p<0.001). The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001). As for the postoperative management of all procedures, the pain score was significantly lower in the WALANT group until the first day after surgery, with the biggest difference at 6hours after surgery. The use of analgesics was significantly lower in the WALANT group until the second day after surgery. Satisfaction with surgery was significantly higher in the WALANT group in all procedures: A1 pulley release (p=0.026), 1st extensor retinaculum (p=0.045), and carpal tunnel release (p=0.003).
DISCUSSION


Our study showed better results in WALANT than in the conventional method, with no tourniquet pain, lower injection pains, longer anesthetic duration, and less postoperative pain. It provided patients with great satisfaction. In addition, WALANT has the potential benefits of no time limit due to tourniquet pain and long anesthetic effect. Therefore, WALANT is comfortable and cost effective, and could be a good alternative to conventional local lidocaine anesthesia.
LEVEL OF EVIDENCE


II.",2020,The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001).,"[""185 patients who received surgical treatment for the diagnosis of carpal tunnel syndrome, trigger finger, or de Quervain's disease between 2017 and 2019""]","['Epinephrine and sodium bicarbonate (NaHCO 3 ', 'minor hand surgeries comparing wide awake local anesthesia no tourniquet and local anesthesia with tourniquet']","['carpal tunnel release', 'injection pain, duration of anesthetic effect, postoperative pain, the use of analgesics, and satisfaction with the surgery', 'postoperative pain', 'Satisfaction with surgery', 'tourniquet pain, lower injection pains, longer anesthetic duration', 'pain score', 'injection pain', 'duration of anesthetic effect']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}, {'cui': 'C0149870', 'cui_str': 'Radial styloid tenosynovitis'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",185.0,0.0554681,The duration of anesthetic effect was significantly longer in the WALANT group in all procedures (p<0.001).,"[{'ForeName': 'Sang', 'Initials': 'S', 'LastName': 'Ki Lee', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea. Electronic address: sklee@eulji.ac.kr.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Gul Kim', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Sik Choy', 'Affiliation': 'Department of Orthopedic Surgery, Eulji University College of Medicine, Daejeon, Korea.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.03.013']
2003,32631795,Nurse-led mind-body relaxation intervention in prison: A multiperspective mixed-method evaluation.,"BACKGROUND


Mind-body relaxation techniques are complementary or alternative to medication to manage high stress and anxiety levels in prisons.
PURPOSE


To assess the motivation to attend and perceived benefits of a nurse-led group relaxation intervention in prison, investigate the experience of participants, prison officers, and health professionals, and identify improvements.
METHOD


Exploratory study was conducted in a post-trial facility in Switzerland using a multiperspective convergent parallel mixed method drawing from participatory action research principles.
FINDINGS


Reasons for attendance included back problems, mental tension, physical fitness, relaxation, and sleep problems. Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness. Qualitative findings converged highlighting the importance of body-centering, relaxation as an alternative to medication, negative representations about relaxation sessions (useless, effeminate), and recommendations for improvement, including audio-visual support for self-practice.
DISCUSSION


Long-standing mind-body relaxation interventions led by nurses in groups may offer participants a beneficial and operationally feasible complement to stress management in prisons.",2020,"Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness.","['Exploratory study was conducted in a post-trial facility in Switzerland using a multiperspective convergent parallel mixed method drawing from participatory action research principles', 'prison']","['Nurse-led mind-body relaxation intervention', 'nurse-led group relaxation intervention']","['back problems, mental tension, physical fitness, relaxation, and sleep problems', 'physical tensions and anxiety, and improvement of sleep and physical fitness']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0001273', 'cui_str': 'Action Research'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0579085', 'cui_str': 'Back problem'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0227782,"Perceived benefits comprised autonomy in self-practice, decreased physical tensions and anxiety, and improvement of sleep and physical fitness.","[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Pralong', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Renaud', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Anne-Dominique', 'Initials': 'AD', 'LastName': 'Secretan', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Marysette', 'Initials': 'M', 'LastName': 'Blanc', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Charmillot', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Mouton', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wolff', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland.'}, {'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Division of Prison Health, Geneva University Hospitals and University of Geneva, Chêne-Bourg, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia. Electronic address: Nguyen-Toan.Tran@unige.ch.'}]",Nursing outlook,['10.1016/j.outlook.2020.05.005']
2004,32631801,Longitudinal Effects of Active Learning Education on Lifestyle Behavior and Physical Function in Older Adults.,"OBJECTIVES


Sustaining benefits of an exercise program is difficult as adherence is often poor after supervised intervention is over. This study aimed to determine whether the effects of active learning education on physical activity, dietary habits, and physical function were maintained 24 weeks after intervention termination in older adults.
DESIGN


Non-randomized controlled trial.
SETTING AND PARTICIPANTS


Community-dwelling older adults aged ≥65 years who were independent in activities of daily living.
METHODS


The intervention group (n = 36) underwent 24 weeks of active learning education. The control group (n = 59) attended a health education class didactically. In both groups, the education program focused on exercise, diet and nutrition, and cognitive activity for health promotion. Active learning included exploratory learning, group work, and self-planning for behavior change that promoted healthy lifestyles. Outcome measures were obtained at baseline (pre), 24 weeks (post), and 48 weeks (follow-up). Physical activity was objectively measured as physical activity level (PAL) using a triaxial accelerometer. Food intake was assessed by obtaining a dietary variety score. Physical function, including gait speed and Timed Up & Go score, was tested as secondary outcome. We used a linear mixed model to estimate the effects of intervention in intention-to-treat analyses.
RESULTS


All outcomes in the intervention group significantly improved compared with the control group at 24 weeks, and the improvements were sustained over a 48-week follow-up period. For PAL, between-group difference in change from baseline was 0.043 (95% confidence interval = 0.007, 0.080) at 24 weeks and 0.061 (0.023, 0.099) at 48 weeks.
CONCLUSIONS AND IMPLICATIONS


Active learning education is effective in enhancing healthy lifestyles and physical function sustainability beyond intervention cessation. A randomized controlled trial with a larger sample size is needed to conclusively clarify the beneficial effects of active health education learning on sustainable behavior change and functional improvement.",2020,"All outcomes in the intervention group significantly improved compared with the control group at 24 weeks, and the improvements were sustained over a 48-week follow-up period.","['Community-dwelling older adults aged ≥65\xa0years who were independent in activities of daily living', 'Older Adults', 'older adults']","['active learning education', 'active health education learning', 'exercise program', 'Active learning education', 'health education class didactically', 'Active Learning Education']","['physical activity, dietary habits, and physical function', 'Lifestyle Behavior and Physical Function', 'physical activity level (PAL', 'Physical activity', 'sustainable behavior change and functional improvement', 'Food intake', 'Physical function, including gait speed and Timed Up & Go score']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.112123,"All outcomes in the intervention group significantly improved compared with the control group at 24 weeks, and the improvements were sustained over a 48-week follow-up period.","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University, Imizu, Japan. Electronic address: kuemura@pu-toyama.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Kamitani', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University, Imizu, Japan.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.014']
2005,32631820,Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women infected with  Schistosoma japonicum .,"An estimated 40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  ( S. ) spp. Treatment with praziquantel (PZQ) via mass drug administration (MDA) campaigns is the mainstay of schistosomiasis control for populations living in endemic areas. The World Health Organization recommends that pregnant and lactating women be included in schistosomiasis MDA programs and several recent studies have evaluated the safety and efficacy of PZQ use during pregnancy. To date, there are no data describing PZQ pharmacokinetics (PK) during pregnancy or among lactating postpartum women. As part of a randomized controlled trial investigating the safety and efficacy of PZQ during human pregnancy, we examined the PK of this therapeutic drug among three distinct cohorts of women infected with  S. japonicum  in Leyte, The Philippines. Specifically, we studied the PK properties of PZQ among early and late gestation pregnant women (N= 15 each) and lactating post-partum women (N=15) with schistosomiasis. We found that women in early pregnancy had increased apparent clearance and lower Area-Under-the-Curve (AUC 0-24 ) that may be related to physiological changes in drug clearance and/or changes in oral bioavailability. There was no relationship between body weight and apparent clearance. The mean ± standard deviation partition ratio of plasma to breast milk was 0.36. ± 0.13 . The estimated median infant PZQ daily dose would be 0.037 mg/kg ingested from breast milk, which is significantly lower than the dosage required for anti-schistosomal activity and not known to be harmful to the infant. Our PK data do not support suggestion to delay breastfeeding 72 hours after taking PZQ. Results can help inform future drug efficacy studies in pregnant and lactating women with schistosomiasis.",2020,There was no relationship between body weight and apparent clearance.,"['populations living in endemic areas', 'three distinct cohorts of women infected with  S. japonicum  in Leyte, The Philippines', 'among early and late gestation pregnant women (N= 15 each) and lactating post-partum women (N=15) with schistosomiasis', 'pregnant and lactating women with schistosomiasis', 'Pregnant and Lactating Filipino Women infected with  Schistosoma japonicum ', 'pregnant and lactating women', 'lactating postpartum women', '40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  ( S. ) spp']","['Praziquantel', 'praziquantel (PZQ) via mass drug administration (MDA) campaigns', 'PZQ']","['body weight and apparent clearance', 'PK properties of PZQ', 'mean ± standard deviation partition ratio of plasma to breast milk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454753', 'cui_str': 'Leyte'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036323', 'cui_str': 'Disease due to Schistosomatidae'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0036317', 'cui_str': 'Schistosoma japonicum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",,0.0915495,There was no relationship between body weight and apparent clearance.,"[{'ForeName': 'Amaya L', 'Initials': 'AL', 'LastName': 'Bustinduy', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK Amaya.Bustinduy@lshtm.ac.uk.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Mirochnick', 'Affiliation': 'Department of Pediatrics, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics University of California, San Diego, La Jolla CA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Department of Epidemiology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool, Liverpool Health Partners Liverpool, UK.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00566-20']
2006,32632075,"[Effect of Emotional Coaching Program for Clinical Nurses on Resilience, Emotional Labor, and Self-efficacy].","PURPOSE


This study aimed to assess the effect of the emotional coaching program for hospital nurses.
METHODS


The study used a non-equivalent control group pretest-posttest design, and participants included 60 nurses (30 in the experimental group and 30 in the control group) who worked at a general hospital. The experimental group attended four sessions, one per week, with each session lasting two and a half hours. Collected data were analyzed using descriptive statistics, Fisher's exact test, χ² test, t-test, paired t-test, and repeated measures ANOVA using SPSS WIN 23.0 program.
RESULTS


Significant differences were shown between the experimental and the control groups regarding emotional labor (F=68.40,  p <.001), resilience (F=48.77,  p <.001), and self-efficacy (F=15.31,  p <.001).
CONCLUSION


The emotional coaching program for nurses is useful for enhancing nurses' emotional labor management, resilience, and self-efficacy. In addition, this program may serve as a basis for providing emotional coaching to nurses in the future.",2020,"The emotional coaching program for nurses is useful for enhancing nurses' emotional labor management, resilience, and self-efficacy.",['participants included 60 nurses (30 in the experimental group and 30 in the control group) who worked at a general hospital'],"['emotional coaching program', 'Emotional Coaching Program']","['self-efficacy', 'emotional labor', 'Resilience, Emotional Labor, and Self-efficacy']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",60.0,0.0382641,"The emotional coaching program for nurses is useful for enhancing nurses' emotional labor management, resilience, and self-efficacy.","[{'ForeName': 'Kyung', 'Initials': 'K', 'LastName': 'Ryu', 'Affiliation': 'Department of Nursing, Seoyeong University, Gwangju, Korea.'}, {'ForeName': 'Jong Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dankook University, Cheonan, Korea. jongkimk@dankook.ac.kr.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.19194']
2007,32632078,[Effect of Lifestyle Intervention Program for Overweight and Obesity Pregnant Women].,"PURPOSE


This study was conducted to identify the effects of a lifestyle intervention program on weight gain, dietary habits, fatigue and pregnancy stress, blood pressure, and neonatal birth weight, using Cox's interaction model of client health behavior for overweight and obese women.
METHODS


This was a quasi-experimental research with a non-equivalent control group pre-post test design. A total of 52 patients who met the selection criteria, including 25 in the experimental group and 27 in the control group, were the subjects of the study; they comprised overweight and obese pregnant women who were receiving prenatal care at A and B women's hospital in J province. The lifestyle intervention program ran for 12 weeks in total and consisted of interactions involving affective support, health information, and professional/technical competencies. The data collection period was from February 1, 2017 to August 31, 2017.
RESULTS


This study showed differences in the appropriate weight gain rate (χ²=6.17,  p =.013), suppression of an increase in fatigue (t=-2.32,  p =.012), and an increase in pregnancy stress (t=-1.87,  p =.034). Yet, no differences in physical activity, dietary habits change, blood pressure, and neonatal birth weight ( p >.05) were found.
CONCLUSION


The study findings indicate that this program could be an effective intervention for the control of appropriate weight gain, fatigue, and pregnancy stress. Therefore, a lifestyle intervention program based on Cox's interaction model of client health behavior could be an efficient strategy for a positive health outcome of overweight and obesity pregnant women.",2020,"This study showed differences in the appropriate weight gain rate (χ²=6.17,  p =.013), suppression of an increase in fatigue (t=-2.32,  p =.012), and an increase in pregnancy stress (t=-1.87,  p =.034).","['overweight and obesity pregnant women', 'Overweight and Obesity Pregnant Women', 'overweight and obese women', ""52 patients who met the selection criteria, including 25 in the experimental group and 27 in the control group, were the subjects of the study; they comprised overweight and obese pregnant women who were receiving prenatal care at A and B women's hospital in J province""]","['Lifestyle Intervention Program', 'lifestyle intervention program']","['weight gain, dietary habits, fatigue and pregnancy stress, blood pressure, and neonatal birth weight', 'fatigue', 'pregnancy stress', 'physical activity, dietary habits change, blood pressure, and neonatal birth weight', 'appropriate weight gain rate']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",52.0,0.0143373,"This study showed differences in the appropriate weight gain rate (χ²=6.17,  p =.013), suppression of an increase in fatigue (t=-2.32,  p =.012), and an increase in pregnancy stress (t=-1.87,  p =.034).","[{'ForeName': 'Hye Kyung', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Jeonbuk National University, Jeonju, Korea.'}, {'ForeName': 'Hyeon Ok', 'Initials': 'HO', 'LastName': 'Kim', 'Affiliation': 'College of Nursing · Research Institute of Nursing Science, Jeonbuk National University, Jeonju, Korea. khok@jbnu.ac.kr.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.19228']
2008,32632173,"Immediate effects of lower limb loading exercise during stepping with and without augmented loading feedback on mobility of ambulatory individuals with spinal cord injury: a single-blinded, randomized, cross-over trial.","STUDY DESIGN


Single-blinded, randomized, cross-over design.
OBJECTIVES


To compare the immediate effects of bodyweight shifting and lower limb loading (LLL) exercise during stepping with and without augmented loading feedback, followed by overground walking, on the mobility of ambulatory individuals with spinal cord injury (SCI).
SETTING


Academic laboratory center.
METHODS


Thirty participants with SCI were trained using a single intervention session consisting of repetitive bodyweight shifting and LLL exercises during stepping with or without external feedback (10 min/leg) followed by overground walking (10 min) with a 2-week washout period, in a random sequence. The timed up-and-go test (TUG) (primary outcome), 10-m walk test (10MWT), five times sit-to-stand test (FTSST), and maximal LLL were measured 1 day before and immediately after each training session.
RESULTS


Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback. Moreover, the improvement following the training with feedback was significantly greater than that after training without feedback. The mean (95% CI) between-group differences for the TUG = 1.9 [0.6-3.3]s, 10MWT = 0.1 [0.0-0.1]m/s, FTSST = 1.0 [1.5-4.8]s, LLL = 3.1 [1.5-4.8]-2.8 [0.8-4.9]%bodyweight, p < 0.05.
CONCLUSIONS


The training programs immediately enhanced the mobility of ambulatory individuals with chronic SCI (post-injury time >6 years), particularly the training with augmented loading feedback. The findings offer another effective rehabilitation strategy that can be applied in various clinical and home-based settings.",2020,"RESULTS


Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback.","['Thirty participants with SCI', 'ambulatory individuals with spinal cord injury', 'ambulatory individuals with spinal cord injury (SCI', 'Academic laboratory center']","['lower limb loading exercise during stepping with and without augmented loading feedback', 'repetitive bodyweight shifting and LLL exercises during stepping with or without external feedback (10\u2009min/leg) followed by overground walking', 'bodyweight shifting and lower limb loading (LLL) exercise during stepping with and without augmented loading feedback, followed by overground walking']","['TUG and LLL of the less-affected leg', '10-m walk test (10MWT), five times sit-to-stand test (FTSST), and maximal LLL', 'mobility of ambulatory individuals with chronic SCI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",30.0,0.0310246,"RESULTS


Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback.","[{'ForeName': 'Teerawat', 'Initials': 'T', 'LastName': 'Nithiatthawanon', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand. pipatana.am@rmuti.ac.th.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nuttaset', 'Initials': 'N', 'LastName': 'Manimmanakorn', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thanat', 'Initials': 'T', 'LastName': 'Sooknuan', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand. samata@kku.ac.th.'}]",Spinal cord,['10.1038/s41393-020-0498-3']
2009,32632265,Author Correction: Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Adults with Major Depression', 'Author Correction']",['Metacognitive Therapy versus Cognitive Behaviour Therapy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0692484,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - Og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-68559-1']
2010,32632364,Videogame intervention to encourage HIV testing and counseling among adolescents.,"Background


Adolescents in the United States account for one-fifth of new HIV cases, and have the highest rate of undiagnosed HIV, with more than half (51%) not knowing their status. It is a crucial public health concern to help equip youth with the information and autonomy to minimize their risk and know their status. Serious videogames are emerging as valuable tools for health and behavior change in adolescents, and have potential to engage this population and increase their use of HIV testing and counseling (HTC). The purpose of this study was to: (I) modify an original serious game targeting risk reduction and HIV prevention developed by the play2PREVENT Lab and create a new serious game that focuses on HTC; (II) evaluate its feasibility and acceptability; (III) pilot-test the assessment measures that are subsequently being used in a large randomized controlled trial.
Methods


Three focus groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for  PlayTest!  After the game was completed, a pilot test was conducted using a one-group pretest-posttest design to collect data on: (I) participants' gameplay satisfaction and experience; (II) the validity of the project's assessments. Twenty-six participants, aged 15-16 were enrolled from a local after-school program. Participants played  PlayTest!  twice weekly for three weeks. Data were collected on behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC at baseline, post-gameplay (three weeks), and follow-up (six weeks).
Results


For the focus groups used in the game development, four major themes emerged: (I) adolescents have strong misperceptions about HTC, including who should get tested and what the test entails; (II) adolescents have incorrect knowledge about how HIV is contracted, spread, and treated; (III) adolescents are supportive of their peers getting tested for HIV, but are not likely to get tested themselves; (IV) while the majority of adolescents know where to get tested for HIV, social stigma, misperceptions around HTC, and fear of having a positive diagnosis keep them from seeking it. For the pilot study, overall, participant experience with the game was highly favorable. The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
Conclusions


The  PlayTest!  game provides promising results regarding using an engaging and evidence-informed videogame intervention to promote HTC in adolescents.",2020,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
","['groups with adolescents, aged 14-17 (n=13, mean age =15), informed artwork and storylines for  PlayTest', 'Twenty-six participants, aged 15-16 were enrolled from a local after-school program', 'adolescents', 'Participants played  PlayTest']",['Videogame intervention'],"['behavior, intentions, knowledge, perceived susceptibility, and attitudes related to HTC']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",26.0,0.0406421,"The assessments were sensitive enough to capture changes in our target variables: intentions (P=0.037) and knowledge (P=0.025) related to HTC at follow-up.
","[{'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Pendergrass', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hieftje', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Duncan', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Fiellin', 'Affiliation': 'Yale Center for Health and Learning Games, Yale School of Medicine, New Haven, CT, USA.'}]",mHealth,['10.21037/mhealth.2020.01.05']
2011,32632365,Internet-delivered acceptance and commitment therapy (iACT) for chronic pain-feasibility and preliminary effects in clinical and self-referred patients.,"Background


Acceptance and commitment therapy (ACT) is an evidence-based treatment to improve functioning and quality of life (QoL) for chronic pain patients, but outreach of this treatment is unsatisfactory. Internet-delivery has been shown to increase treatment access but there is limited evidence regarding feasibility and effectiveness of web-based ACT for chronic pain. The aim of the study was to evaluate and iterate a novel internet-delivered ACT program, iACT, in a clinical and a self-referred sample of chronic pain patients. The intervention was developed in close collaboration with patients. To enhance learning, content was organized in short episodes to promote daily engagement in treatment. In both the clinical and self-referred samples, three critical domains were evaluated: (I) feasibility (acceptability, practicality and usage); (II) preliminary efficacy on pain interference, psychological inflexibility, value orientation, QoL, pain intensity, anxiety, insomnia and depressive symptoms; and (III) potential treatment mechanisms.
Methods


This was an open pilot study with two samples: 15 patients from a tertiary pain clinic and 24 self-referred chronic pain participants, recruited from October 2015 until January 2017. Data were collected via an online platform in free text and self-report measures, as well as through individual oral feedback. Group differences were analyzed with Chi square-, Mann-Whitney U- or  t -test. Preliminary efficacy and treatment mechanism data were collected via self-report and analyzed with multilevel linear modeling for repeated measures.
Results


Feasibility: patient feedback guided modifications to refine the intervention and indicated that iACT was acceptable in both samples. User insights provided input for both immediate and future actions to improve feasibility. Comprehensiveness, workability and treatment credibility were adequate in both samples. Psychologists spent on average 13.5 minutes per week per clinical patient, and 8 minutes per self-referred patient (P=0.004). Recruitment rate was 24 times faster in the self-referred sample (24 patients in 1 month, compared to 15 patients in 15 months, P<0.001) and the median distance to the clinic was 40 km in the clinical sample, and 426 km in the self-referred sample (P<0.001). Preliminary effects: post-assessments were completed by 26 participants (67%). Significant effects of time were seen from pre- to post-treatment across all outcome variables. Within group effect sizes (Cohen's  d ) at post-treatment ranged from small to large: pain interference ( d =0.64, P<0.001), psychological inflexibility ( d =1.43, P<0.001), value progress ( d =0.72, P<0.001), value obstruction ( d =0.42, P<0.001), physical QoL ( d =0.41, P=0.005), mental QoL ( d = 0. 67, P=0.005), insomnia ( d= 0.31, P <0. 001), depressive symptoms ( d =0.47, P<0.001), pain intensity ( d =0.78, P=0.001) and anxiety ( d = 0. 46, P<0.001). Improvements were sustained at 1-year follow-up. Psychological inflexibility and value progress were found to be potential treatment mechanisms.
Conclusions


The results from the present study suggests that iACT was feasible in both the clinical and the self-referred sample. Together with the positive preliminary results on all outcomes, the findings from this feasibility study pave the way for a subsequent large randomized efficacy trial.",2020,"Recruitment rate was 24 times faster in the self-referred sample (24 patients in 1 month, compared to 15 patients in 15 months, P<0.001) and the median distance to the clinic was 40 km in the clinical sample, and 426 km in the self-referred sample (P<0.001).","['26 participants (67', 'two samples: 15 patients from a tertiary pain clinic and 24 self-referred chronic pain participants, recruited from October 2015 until January 2017', 'clinical and self-referred patients', 'chronic pain patients']","['\n\n\nAcceptance and commitment therapy (ACT', 'Internet-delivered acceptance and commitment therapy (iACT', 'iACT']","['feasibility (acceptability, practicality and usage); (II) preliminary efficacy on pain interference, psychological inflexibility, value orientation, QoL, pain intensity, anxiety, insomnia and depressive symptoms; and (III) potential treatment mechanisms', 'anxiety', 'pain intensity', 'Comprehensiveness, workability and treatment credibility', 'functioning and quality of life (QoL', 'insomnia', 'Recruitment rate', 'value obstruction', 'physical QoL', 'psychological inflexibility', 'mental QoL', 'pain interference', 'depressive symptoms']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0042294', 'cui_str': 'Value Orientation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0905813,"Recruitment rate was 24 times faster in the self-referred sample (24 patients in 1 month, compared to 15 patients in 15 months, P<0.001) and the median distance to the clinic was 40 km in the clinical sample, and 426 km in the self-referred sample (P<0.001).","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rickardsson', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Vendela', 'Initials': 'V', 'LastName': 'Zetterqvist', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gentili', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Holmström', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Persson', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Functional Unit Behavioral Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",mHealth,['10.21037/mhealth.2020.02.02']
2012,32632394,Does laparoscopy decrease incisional hernia and bowel obstruction rates after rectal cancer surgery?-results of 5 years follow-up in a randomized trial (COLOR II).,,2020,,[],[],['incisional hernia and bowel obstruction rates'],[],[],"[{'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}]",,0.0444606,,"[{'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Benlice', 'Affiliation': 'Department of General Surgery, Acibadem Mehmet Ali Aydinlar University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Bilgi', 'Initials': 'B', 'LastName': 'Baca', 'Affiliation': 'Department of General Surgery, Acibadem Mehmet Ali Aydinlar University, School of Medicine, Istanbul, Turkey.'}]",Translational gastroenterology and hepatology,['10.21037/tgh.2019.12.12']
2013,32249256,Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up.,"PURPOSE


Our study aimed to investigate the structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) using J-Valve.
METHODS


In all, 14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR) were available in the study. Four-year follow-up was performed in all patients, and the clinical data and echocardiographic findings were recorded and analyzed.
RESULTS


All patients survived at the 4-year follow-up. There was no evidence of morphological SVD or prosthetic valve thrombosis in enrolled patients. None of the hemodynamic SVD occurred in patients with PAR. Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967). Overall, in patients with AS, six individuals suffered moderate (3/14, 21.4%) or severe (3/14, 21.4%) hemodynamic SVD at 4-year follow-up.
CONCLUSIONS


The limited number of cases provides a preliminary indication of the long-term efficacy of TAVI using J-Valve in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamics remained stable over time after prosthetic valve implantation and the long-term durability of J-Valve was convincing.",2020,"Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967).","['patients with PAR', '14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR']","['Transcatheter Aortic Valve Implantation Using J-Valve', 'transcatheter aortic valve implantation (TAVI) using J-Valve']","['overall transcatheter heart valve (THV) hemodynamics', 'morphological SVD or prosthetic valve thrombosis', 'hemodynamic SVD', 'rate of SVD', 'Mean gradients', 'mean trans-aortic gradient', 'structural valve deterioration (SVD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C4285833', 'cui_str': 'Structural valve deterioration'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}]",14.0,0.0213406,"Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Yuetang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Structural Heart Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Cardiovascular Disease, Beijing, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.19-00325']
2014,32271278,Integrated Radiologic Algorithm for COVID-19 Pandemic.,,2020,,[],[],[],[],[],[],,0.0188247,,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Unit of Radiological Sciences, Department of Medicine and Surgery, University of Parma, Parma.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Milanese', 'Affiliation': 'Unit of Radiological Sciences, Department of Medicine and Surgery, University of Parma, Parma.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Milone', 'Affiliation': 'Unit of Radiological Sciences, Department of Medicine and Surgery, University of Parma, Parma.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Balbi', 'Affiliation': 'Department of Radiology, Papa Giovanni XXIII Hospital Bergamo, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Roberta E', 'Initials': 'RE', 'LastName': 'Ledda', 'Affiliation': 'Unit of Radiological Sciences, Department of Medicine and Surgery, University of Parma, Parma.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Unit of Radiological Sciences, Department of Medicine and Surgery, University of Parma, Parma.'}]",Journal of thoracic imaging,['10.1097/RTI.0000000000000516']
2015,32315295,Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer.,"There is growing interest in leveraging real-world data to complement knowledge gained from randomized clinical trials and inform the design of prospective randomized studies in oncology. The present study compared clinical outcomes in women with metastatic breast cancer who received letrozole as first-line monotherapy in oncology practices across the United States versus patients in the letrozole-alone cohort of the PALOMA-2 phase 3 trial. The real-world cohort (N = 107) was derived from de-identified patient data from the Flatiron Health electronic health record database. The clinical trial cohort (N = 222) comprised postmenopausal women in the letrozole-alone arm of PALOMA-2. Patients in the real-world cohort received letrozole monotherapy per labeling and clinical judgment; patients in PALOMA-2 received letrozole 2.5 mg/d, continuous. Real-world survival and response rates were based on evidence of disease burden curated from clinician notes, radiologic reports, and pathology reports available in the electronic health record. Progression-free survival and objective response rate in PALOMA-2 were based on Response Evaluation Criteria in Solid Tumors v1.1. Concordance of survival and response rates were retrospectively assessed using inverse probability of treatment weighting-adjusted Cox regression analysis. Inverse probability of treatment weighting-adjusted Cox regression results showed similar median progression-free survival in the real-world and PALOMA-2 cohorts (18.4 and 16.6 months, respectively): the hazard ratio using real-world data as reference was 1.04 (95% CI, 0.69-1.56). No significant difference was observed in response rates: 41.8% in the real-world cohort vs 39.4% in the PALOMA-2 cohort (odds ratio using real-world data as reference: 0.91 [95% CI, 0.57-1.44]). These findings indicate that data abstracted from electronic health records with proper quality controls can yield meaningful information on clinical outcomes. These data increase confidence in the use of real-world assessments of progression and response as efficacy endpoints. Trial registration NCT01740427; Funding: Pfizer.",2020,"No significant difference was observed in response rates: 41.8% in the real-world cohort vs 39.4% in the PALOMA-2 cohort (odds ratio using real-world data as reference: 0.91 [95% CI, 0.57-1.44]).","['women with metastatic breast cancer who received', 'metastatic breast cancer', 'as first-line monotherapy in oncology practices across the United States versus patients in the letrozole-alone cohort of the PALOMA-2 phase 3 trial']","['endocrine therapy', 'letrozole', 'letrozole-alone arm of PALOMA-2', 'letrozole monotherapy']","['Real-world survival and response rates', 'Progression-free survival and objective response rate', 'median progression-free survival', 'response rates', 'Concordance of survival and response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",222.0,0.183032,"No significant difference was observed in response rates: 41.8% in the real-world cohort vs 39.4% in the PALOMA-2 cohort (odds ratio using real-world data as reference: 0.91 [95% CI, 0.57-1.44]).","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer Inc, New York, NY, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Mardekian', 'Affiliation': 'Pfizer Inc, New York, NY, United States of America.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Cotter', 'Affiliation': 'Pfizer Inc, New York, NY, United States of America.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pfizer Inc, New York, NY, United States of America.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, New York, NY, United States of America.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Parrinello', 'Affiliation': 'Flatiron Health, New York, NY, United States of America.'}, {'ForeName': 'Ariel Bulua', 'Initials': 'AB', 'LastName': 'Bourla', 'Affiliation': 'Flatiron Health, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0227256']
2016,32618115,A mobile health-facilitated behavioural intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: a cluster randomized trial.,"INTRODUCTION


India's national AIDS Control Organization implemented World Health Organization's option B+ HIV prevention of mother-to-child transmission (PMTCT) guidelines in 2013. However, scalable strategies to improve uptake of new PMTCT guidelines to reduce new infection rates are needed. This study assessed impact of Mobile Health-Facilitated Behavioral Intervention on the uptake of PMTCT services.
METHODS


A cluster-randomized trial of a mobile health (mHealth)-supported behavioural training intervention targeting outreach workers (ORWs) was conducted in four districts of Maharashtra, India. Clusters (one Integrated Counselling and Testing Center (ICTC, n = 119), all affiliated ORWs (n = 116) and their assigned HIV-positive pregnant/postpartum clients (n = 1191)) were randomized to standard-of-care (SOC) ORW training vs. the COMmunity home Based INDia (COMBIND) intervention - specialized behavioural training plus a tablet-based mHealth application to support ORW-patient communication and patient engagement in HIV care. Impact on uptake of maternal antiretroviral therapy at delivery, exclusive breastfeeding at six months, infant nevirapine prophylaxis, and early infant diagnosis at six months was assessed using multi-level random-effects logistic regression models.
RESULTS


Of 1191 HIV-positive pregnant/postpartum women, 884 were eligible for primary outcome assessment; 487 were randomized to COMBIND. Multivariable analyses identified no statistically significant differences in any primary outcome by study arm. COMBIND was associated with higher uptake of exclusive breastfeeding at two months (adjusted Odds Ratio (aOR), 2.10; 95% CI 1.06 to 4.15) and early infant diagnosis at six weeks (aOR, 2.19; 95% CI 1.05 to 3.98) than SOC.
CONCLUSIONS


The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy. Further study would identify modifications needed to optimize other PMTCT outcomes.",2020,"The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy.","['Clusters (one Integrated Counselling and Testing Center (ICTC, n\xa0=\xa0119), all affiliated ORWs (n\xa0=\xa0116) and their assigned HIV-positive pregnant/postpartum clients (n\xa0=\xa01191', 'targeting outreach workers (ORWs) was conducted in four districts of Maharashtra, India', 'community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India', '1191 HIV-positive pregnant/postpartum women, 884 were eligible for primary outcome assessment; 487']","['mobile health-facilitated behavioural intervention', 'mobile health (mHealth)-supported behavioural training intervention', 'specialized behavioural training plus a tablet-based mHealth application to support ORW-patient communication and patient engagement in HIV care', 'standard-of-care (SOC) ORW training vs. the COMmunity home Based INDia', 'Mobile Health-Facilitated Behavioral Intervention']","['higher uptake of exclusive breastfeeding', 'early infant diagnosis']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.232194,"The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy.","[{'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kadam', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Hegde', 'Affiliation': 'National AIDS Control Organization, New Delhi, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Sivalenka', 'Affiliation': 'Division of Global HIV & TB - India Country Office, US Centers for Disease Control and Prevention, New Delhi, India.'}, {'ForeName': 'V Sampath', 'Initials': 'VS', 'LastName': 'Kumar', 'Affiliation': 'Division of Global HIV & TB - India Country Office, US Centers for Disease Control and Prevention, New Delhi, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Bollinger', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McKenzie-White', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25555']
2017,32618258,Impact of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction among Young Laotian Children: A Randomized Controlled Trial.,"The objective of this study was to assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL) among young Laotian children. In a double-blind controlled trial, children aged 6-23 months were randomized to receive either daily preventive zinc (PZ) tablets (7 mg/day), daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment (20 mg/day for 10 days), or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO, and CAL concentrations were determined in a randomly selected subsample of 720 children using commercially available ELISA kits. At baseline, the mean age was 14.1 ± 4.9 months and prevalence of stunting was 39%. The endline prevalence of stunting was 43%; there was no overall treatment effect on physical growth in the parent trial. At endline, the mean (95% CI) MPO in the PZ group was 1,590 [1,396; 1,811] ng/mL and did not differ from that in the MNP (1,633 [1,434; 1,859] ng/mL), TZ (1,749 [1,535; 1,992] ng/mL), and control (1,612 [1,415; 1,836] ng/mL) groups ( P  = 0.749). Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively). In this population, the provision of PZ or TZ supplements or MNP had no impact on growth or environmental enteric dysfunction (EED) as assessed by fecal MPO, NEO, and CAL. Additional research is needed to better understand the etiology and proposed mechanisms of EED pathogenesis.",2020,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","['young Laotian children', 'Young Laotian Children', 'children aged 6-23 months']","['daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment', 'placebo powder', 'daily preventive zinc (PZ) tablets', 'TZ', 'PZ or TZ supplements or MNP', 'MNP']","['prevalence of stunting', 'fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL', 'physical growth', 'Fecal MPO, NEO, and CAL concentrations', 'growth or environmental enteric dysfunction (EED', 'NEO and CAL concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",720.0,0.568268,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P  = 0.226 and 0.229, respectively).","[{'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Helen Keller International, Washington, District of Columbia.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Somphou', 'Initials': 'S', 'LastName': 'Sayasone', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0106']
2018,32618522,Investigating the learning curve in endoscopic compared to microscopic myringotomy and ventilation tube insertion.,"OBJECTIVE


Rate of learning is often cited as a deterrent in the use of endoscopic ear surgery. This study investigated the learning curves of novice surgeons performing simulated ear surgery using either an endoscope or a microscope.
METHODS


A prospective multi-site clinical research study was conducted. Seventy-two medical students were randomly allocated to the endoscope or microscope group, and performed 10 myringotomy and ventilation tube insertions. Trial times were used to produce learning curves. From these, slope (learning rate) and asymptote (optimal proficiency) were ascertained.
RESULTS


There was no significant difference between the learning curves (p = 0.41). The learning rate value was 68.62 for the microscope group and 78.71 for the endoscope group. The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group.
CONCLUSION


The absence of a significant difference shows that the learning rates of each technique are statistically indistinguishable. This suggests that surgeons are not justified when citing 'steep learning curve' in arguments against the use of endoscopes in middle-ear surgery.",2020,"The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group.
",['Seventy-two medical students'],"['microscopic myringotomy and ventilation tube insertion', 'endoscope or microscope group, and performed 10 myringotomy and ventilation tube insertions', 'novice surgeons performing simulated ear surgery using either an endoscope or a microscope']","['learning curves', 'learning rates', 'learning rate value']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.022179,"The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group.
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Denton', 'Affiliation': 'Postgraduate Centre, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daglish', 'Affiliation': 'Postgraduate Medical Education Centre, Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Smallman', 'Affiliation': 'School of Mathematics, Cardiff University, Wales, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fishpool', 'Affiliation': 'Department of ENT, Cwm Taf Morgannwg University Health Board, Ynysmaerdy, Wales, UK.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001188']
2019,32618656,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
2020,32618692,Prospective Randomized Controlled Trial of Video- Versus Recall-Assisted Reflection in Simulation-Based Teaching on Acquisition and Retention of Airway Skills Among Trainees Intubating Critically Ill Patients.,"OBJECTIVES


Conventionally, simulation-based teaching involves reflection on recalled events (recall-assisted reflection). Instead of recall, video-assisted reflection may reduce recall bias and improve skills retention by contributing to visual memory. Here, we test the hypothesis that when compared with recall, video-assisted reflection results in higher acquisition and retention of skills involved in airway management among junior critical care doctors.
DESIGN


Randomized control trial. Participants were randomized 1:1 to video-assisted reflection or recall-assisted reflection group.
SETTING


University-affiliated tertiary care center.
SUBJECTS


Junior critical care doctors.
INTERVENTION


Video-assisted reflection.
MEASUREMENTS AND MAIN RESULTS


All participants underwent simulation-based teaching of technical and nontechnical airway skills involved in managing a critically ill patient. These skills were assessed before, post-workshop, and in the following fourth week, by two independent blinded assessors using a validated scoring tool. Quality of debrief was assessed using a validated questionnaire. Repeated-measures analysis of variance was used to assess time and group interaction. Forty doctors were randomized. At baseline, the groups had similar airway experience (p = 0.34) and skill scores (p = 0.97). There was a significant interaction between study groups and changes over time for total skill scores (F[2, 37] = 4.06; p = 0.02). Although both the study groups had similar and significant improvement in total skills scores at the postworkshop assessment, the decline in total skills scores at delayed assessment (F[1, 38] = 5.64; p = 0.02) was significantly more in the recall-assisted reflection group when compared with the video-assisted reflection group. This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01). Better retention was predominantly in the nontechnical skills. The perceived quality of debrief was similar between the two groups.
CONCLUSION


When compared with recall, video-assisted reflection resulted in similar improvement in airway skills, but better retention over time.",2020,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"['junior critical care doctors', 'Intubating Critically Ill Patients', 'Junior critical care doctors', 'Forty doctors', 'University-affiliated tertiary care center', 'Trainees']","['video-assisted reflection or recall-assisted reflection group', 'Video', 'Video-assisted reflection']","['total skills scores', 'quality of debrief', 'airway skills', 'mean skill scores', 'Skills', 'recall bias and improve skills retention', 'total skill scores', 'Acquisition and Retention of Airway', 'similar airway experience', 'skill scores', 'Quality of debrief']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",40.0,0.212539,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"[{'ForeName': 'Shivesh', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': '1College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia. 2Intensive Care, Flinders Medical Centre, Bedford Park, SA, Australia. 3Department of Anaesthesia, Flinders Medical Centre, Bedford Park, SA, Australia. 4Division of Medicine, Southern Adelaide Health Network, Adelaide, SA, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': ''}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Laver', 'Affiliation': ''}, {'ForeName': 'Giresh', 'Initials': 'G', 'LastName': 'Chandran', 'Affiliation': ''}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Kerr', 'Affiliation': ''}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Schuwirth', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bersten', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004448']
2021,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
2022,32619848,The influence of placebo administration on the first- night effect in patients with insomnia disorder.,"OBJECTIVE


We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs.
METHODS


In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights.
RESULTS


The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
CONCLUSION


In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.",2020,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","['patients with insomnia disorder', 'Twenty patients with insomnia disorder (drug-free group, DF', 'All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory', '36 patients with insomnia disorder who met the DSM-5 criteria', 'insomniacs', 'Sixteen patients with insomnia disorder']","['placebo intervention (placebo-administration group, PL', 'placebo']","['duration and percentage of N1, N2, N3 and REM', 'Sleep diaries', 'occurrence of worse sleep', 'lower self-reported total sleep time (TST) and more subjective WASO', 'sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO', 'sleep efficiency (SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",36.0,0.0242769,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","[{'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Yuezhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neuropsychiatry, Behavioral Neurology and Sleep Center, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Sleep Medicine Center, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Physiology, College of Basic Medicine, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Translational Neuroscience Center, State Key Laboratory, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 2372564613@qq.com.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China. Electronic address: sunhq@bjmu.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.002']
2023,32619868,Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.,"Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (""X:BOT"") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.",2020,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","['black adults', '73 Black participants with OUD (81% male, mean age 39.05, SD\xa0=\xa011.80) participating']","['extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'naltrexone', 'buprenorphine-naloxone']",['relapse rates'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",73.0,0.101327,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Haeny', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 34 Park St., New Haven, CT 06511, United States. Electronic address: angela.haeny@yale.edu.'}, {'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, 3131 Harvey Avenue., Cincinnati, OH 45229, United States.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Department of Psychology, 2600 Clifton Ave., Cincinnati, OH 45221, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, One Park Ave., New York, NY 10016, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106514']
2024,32620149,"Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.","BACKGROUND


Patients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer.
METHODS


ABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application.
DISCUSSION


An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.
TRIAL REGISTRATION


NCT number: NCT04354233 .",2020,"Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants.","['women with metastatic breast cancer', '244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned', 'patients with a metastatic breast cancer', 'Patients with a metastatic breast cancer']","['physical activity program', 'physical activity recommendations, an activity tracker to wear 24\u2009h a day during the whole intervention (6\u2009months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only']","['quality of life', 'health-related quality of life and reduce fatigue', 'Health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",244.0,0.0680548,"Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Delrieu', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Freyssenet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, Univ Lyon, University Jean Monnet Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Aurélia', 'Initials': 'A', 'LastName': 'Maire', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Canada', 'Affiliation': 'Laboratory on Vulnerabilities and Innovations in Sport, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Febvey-Combes', 'Affiliation': 'Department of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Pilleul', 'Affiliation': 'Department of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Bouhamama', 'Affiliation': 'Department of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caux', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Cancer Research Center of Lyon (CRCL), Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Medical Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pialoux', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Department of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Pérol', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France. olivia.perol@lyon.unicancer.fr.'}]",BMC cancer,['10.1186/s12885-020-07093-9']
2025,32620155,"A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency.","BACKGROUND


The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency.
METHODS


Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone.
RESULTS


Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo.
CONCLUSION


This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.
TRIAL REGISTRATION


CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.",2020,"There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo.
","['benign prostate hyperplasia (BPH) and androgen deficiency', 'Subjects aged 40-65\u2009years with symptomatic BPH']","['β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo', 'phytosterol-enriched and conventional saw palmetto oil', 'standardized saw palmetto oil containing 3% β-sitosterol', 'placebo']","['IPSS, AMS and ADAM scores', 'maximum and average urine flow rate', 'serum free testosterone level', 'Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone', 'efficacy and tolerability', 'PSA', 'BPH severity', 'International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase']","[{'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]",,0.41981,"There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo.
","[{'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Sudeep', 'Affiliation': 'R&D Center for Excellence, Vidya Herbs Pvt. Ltd, #14A, Jigani I phase, Bangalore, Karnataka, 560 105, India. sudeepkashyap.82@gmail.com.'}, {'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research and Bio services Private Ltd., Bangalore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shyamprasad', 'Affiliation': 'R&D Center for Excellence, Vidya Herbs Pvt. Ltd, #14A, Jigani I phase, Bangalore, Karnataka, 560 105, India.'}]",BMC urology,['10.1186/s12894-020-00648-9']
2026,32620163,ICON: a randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone receptor positive breast cancer.,"BACKGROUND


Immunotherapy with checkpoint inhibitors (CPI) targeting PD-1 or CTLA-4 has emerged as an important treatment modality for several cancer forms. In hormone receptor positive breast cancer (HR + BC), this therapeutic approach is largely unexplored. We have started a clinical trial, ICON (CA209-9FN), evaluating CPI combined with selected chemotherapy in patients with metastatic HR + BC. The tumor lymphocyte infiltration is predictive for the effect of chemotherapy in BC. In ICON, we use anthracycline, which are considered as ""immunogenic"" chemotherapy, and low-dose cyclophosphamide, which has been reported to counter immunosuppressive cells.
METHODS


ICON is a randomized exploratory phase IIb study evaluating the safety and efficacy of combining nivolumab (nivo; anti-PD-1) and ipilimumab (ipi; anti-CTLA-4) with chemotherapy in subjects with metastatic HR + BC. Primary objectives are aassessment of toxicity and progression-free survival. The trial will enrol 75 evaluable subjects, randomized 2:3 into two arms (A:B). Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin (PLD 20 mg/m 2  intravenously every 2nd week) + cyclophosphamide (cyclo; 50 mg per day, first 2 weeks in each 4 week cycle). Patients in Arm B receive PLD + cyclo + ipilimumab (1 mg intravenously every 6th week) + nivolumab (240 mg intravenously every 2nd week). Patients in arm A will be offered ipi + nivo after disease progression.
DISCUSSION


ICON is among the first clinical trials combining chemotherapy with PD-1 and CTLA-4 blockade, and the first in BC. There is a strong preclinical rationale for exploring if anthracyclines, which are considered to induce immunogenic cell death, synergize with CPI, and for combining PD-1 and CTLA-4 blockade, as these checkpoints are important in different phases of the immune response. If the ICON trial suggests acceptable safety and provide a signal of clinical efficacy, further studies are warranted. The cross-over patients from Arm A receiving ipilimumab/nivolumab without concomitant chemotherapy represent the first BC cohort receiving this therapy. The ICON trial includes a series of translational sub-projects addressing clinically important knowledge gaps. These studies may uncover biomarkers or mechanisms of efficacy and resistance, thereby informing the development of novel combinatory regimes and of personalised biomarker-based therapy. Trial registration NCT03409198, Jan 24th 2018; https://clinicaltrials.gov/ct2/show/record/NCT03409198.",2020,"Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin","['patients with metastatic hormone', '75 evaluable subjects', 'subjects with metastatic HR\u2009+\u2009BC', 'patients with metastatic HR\u2009+\u2009BC', 'receptor positive breast cancer']","['ICON', 'combining nivolumab (nivo; anti-PD-1) and ipilimumab (ipi; anti-CTLA-4) with chemotherapy', 'cyclophosphamide', 'CPI combined with selected chemotherapy', 'immunogenic chemotherapy combined with ipilimumab and nivolumab', 'ipilimumab/nivolumab without concomitant chemotherapy', 'chemotherapy, i.e. pegylated liposomal doxorubicin', 'PLD\u2009+\u2009cyclo\u2009+\u2009ipilimumab']","['safety and efficacy', 'aassessment of toxicity and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': '1-dodecylpyridoxal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0648991,"Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kyte', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway. jonky@ous-hf.no.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Andresen', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Russnes', 'Affiliation': 'Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'S Ø', 'Initials': 'SØ', 'LastName': 'Fretland', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Falk', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Lingjærde', 'Affiliation': 'Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",Journal of translational medicine,['10.1186/s12967-020-02421-w']
2027,32620174,Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial.,"OBJECTIVES


As there is no treatment for COVID-19 with a proven mortality benefit at this moment in the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation, highly demanding and leading to potential staff shortages in ICU. We need to reduce unnecessary exposure of healthcare workers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19. In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19.
TRIAL DESIGN


A pilot multicenter prospective crossover noninferiority randomized controlled trial.
PARTICIPANTS


All mechanically ventilated patients with COVID-19 admitted to one of the two ICUs, and CPT ordered by the responsible physician. The participants will be recruited from two intensive care units in Canadian Academic Hospitals (one pediatric and one adult ICU).
INTERVENTION AND COMPARATOR


We will implement NIOD and CPT alternatingly for 3 h apart over 3 h. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, intermittent positive pressure ventilation, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing positive end-expiratory pressure or changing the nasal mask to total face continuous positive airway pressure) can be provided at the direction of bedside intensivists in charge.
MAIN OUTCOMES


The primary outcome measurement is the oxygenation level before and after the procedure (SpO 2 /FiO 2  ratio). For cases with invasive ventilation (i.e., the use of an endotracheal tube to deliver positive pressure) and non-invasive ventilation, we will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, hypoxemia, or unexpected extubation. We will collect the data before, 10 min after, and 30 min after the procedure.
RANDOMIZATION


The order of the procedures (i.e., NIOD or CPT) will be randomly allocated using manual generated random numbers for each case. Randomization will be carried out by the independent research assistant in the study coordinating center by using opaque sealed envelopes, assigning an equal number of cases to each intervention arm. Stratification will be applied for age (> 18 years or ≤ 18 years of age) and the study sites.
BLINDING (MASKING)


No blinding will be performed.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


We estimate the necessary sample size as 25 for each arm (total 50 cases), with a power of 0.90 and an alpha of 0.05, with a non-inferiority design.
TRIAL STATUS


The protocol version number 1 was approved on 27 March 2020. Currently, recruitment has not yet started, with the start scheduled by the mid-June 2020 and the end anticipated by December 2020.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04361435 . Registered on 28 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19.
","['All mechanically ventilated patients with COVID-19 admitted to one of the two ICUs, and CPT ordered by the responsible physician', 'mechanically ventilated patients with COVID-19', 'participants will be recruited from two intensive care units in Canadian Academic Hospitals (one pediatric and one adult ICU', 'age (>\u200918\u2009years or\u2009≤\u200918\u2009years of age) and the study sites', 'Registered on 28 April 2020', 'critically ill children and adults with COVID-19 infection', 'physiotherapists caring for patients with COVID-19']","['care using a non-invasive oscillating device (NIOD', 'standard chest physiotherapy (CPT', 'hypertonic saline nebulization, intermittent positive pressure ventilation, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing positive end-expiratory pressure or changing the nasal mask to total face continuous positive airway pressure']",['oxygenation level'],"[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.189601,"In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19.
","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Bernier', 'Affiliation': 'School of Medicine, University of Montreal, Quebec, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Saly', 'Initials': 'S', 'LastName': 'El Salti', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'McGill Interdisciplinary Initiative in Infection and Immunity, Quebec, Canada.'}, {'ForeName': 'Kosar', 'Initials': 'K', 'LastName': 'Khwaja', 'Affiliation': 'Réseau de Recherche en Santé Respiratoire du Québec, Quebec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jouvet', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada. philippe.jouvet@umontreal.ca.'}]",Trials,['10.1186/s13063-020-04533-6']
2028,32620866,Spa therapy with physical rehabilitation is an alternative to usual spa therapy protocol in symptomatic knee osteoarthritis.,"The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.",2020,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"['patients with symptomatic KOA', 'symptomatic knee osteoarthritis (KOA', '283 patients included, 145 were allocated to', 'patients who live close to a centre', 'symptomatic knee osteoarthritis']","['Spa therapy with physical rehabilitation', 'Spa-rehab therapy', 'standard spa therapy', 'low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy']","['achieving at 6\xa0months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII', 'composite MCII at 3\xa0months and achieving a Patient Acceptable Symptom State (PASS) for pain and function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}]",283.0,0.040187,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"[{'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Rat', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France. rat-ac@chu-caen.fr.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Loeuille', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Vallata', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Inserm CIC-EC 1433, Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Spitz', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Desvignes', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boulange', 'Affiliation': 'Université de Lorraine, Nancy, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paysant', 'Affiliation': 'Regional Institute for Physical and Rehabilitation Medicine-Louis Pierquin Center of Nancy, 54500, Nancy, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Guillemin', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}]",Scientific reports,['10.1038/s41598-020-67436-1']
2029,31624633,Quantitative systems toxicology (QST) reproduces species differences in PF-04895162 liver safety due to combined mitochondrial and bile acid toxicity.,"Many compounds that appear promising in preclinical species, fail in human clinical trials due to safety concerns. The FDA has strongly encouraged the application of modeling in drug development to improve product safety. This study illustrates how DILIsym, a computational representation of liver injury, was able to reproduce species differences in liver toxicity due to PF-04895162 (ICA-105665). PF-04895162, a drug in development for the treatment of epilepsy, was terminated after transaminase elevations were observed in healthy volunteers (NCT01691274). Liver safety concerns had not been raised in preclinical safety studies. DILIsym, which integrates in vitro data on mechanisms of hepatotoxicity with predicted in vivo liver exposure, reproduced clinical hepatotoxicity and the absence of hepatotoxicity observed in the rat. Simulated differences were multifactorial. Simulated liver exposure was greater in humans than rats. The simulated human hepatotoxicity was demonstrated to be due to the interaction between mitochondrial toxicity and bile acid transporter inhibition; elimination of either mechanism from the simulations abrogated injury. The bile acid contribution occurred despite the fact that the IC 50  for bile salt export pump (BSEP) inhibition by PF-04895162 was higher (311 µmol/L) than that has been generally thought to contribute to hepatotoxicity. Modeling even higher PF-04895162 liver exposures than were measured in the rat safety studies aggravated mitochondrial toxicity but did not result in rat hepatotoxicity due to insufficient accumulation of cytotoxic bile acid species. This investigative study highlights the potential for combined in vitro and computational screening methods to identify latent hepatotoxic risks and paves the way for similar and prospective studies.",2019,"This study illustrates how DILIsym, a computational representation of liver injury, was able to reproduce species differences in liver toxicity due to PF-04895162 (ICA-105665).",[],[],"['mitochondrial toxicity', 'Simulated liver exposure', 'liver toxicity']",[],[],"[{'cui': 'C1096176', 'cui_str': 'Mitochondrial toxicity'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0281877,"This study illustrates how DILIsym, a computational representation of liver injury, was able to reproduce species differences in liver toxicity due to PF-04895162 (ICA-105665).","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Generaux', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}, {'ForeName': 'Vinal V', 'Initials': 'VV', 'LastName': 'Lakhani', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}, {'ForeName': 'Yuching', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}, {'ForeName': 'Sashi', 'Initials': 'S', 'LastName': 'Nadanaciva', 'Affiliation': 'Compound Safety Prediction Worldwide Medicinal Chemistry Pfizer Inc. Groton Connecticut.'}, {'ForeName': 'Luping', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Investigative Toxicology Drug Safety Research and Development Pfizer Inc. Groton Connecticut.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Riccardi', 'Affiliation': 'Pharmacokinetics, Dynamics and Metabolism Medicinal Sciences Pfizer Inc. Groton Connecticut.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Di', 'Affiliation': 'Pharmacokinetics, Dynamics and Metabolism Medicinal Sciences Pfizer Inc. Groton Connecticut.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Howell', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}, {'ForeName': 'Scott Q', 'Initials': 'SQ', 'LastName': 'Siler', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Watkins', 'Affiliation': 'UNC Eshelman School of Pharmacy University of North Carolina at Chapel Hill Chapel Hill North Carolina.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Barton', 'Affiliation': 'Translational Modeling and Simulation Biomedicine Design Pfizer, Inc. Groton Connecticut.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Aleo', 'Affiliation': 'Investigative Toxicology Drug Safety Research and Development Pfizer Inc. Groton Connecticut.'}, {'ForeName': 'Lisl K M', 'Initials': 'LKM', 'LastName': 'Shoda', 'Affiliation': 'DILIsym Services Inc. Research Triangle Park North Carolina.'}]",Pharmacology research & perspectives,['10.1002/prp2.523']
2030,31669298,Participation Restrictions and Satisfaction With Participation in Partners of Patients With Stroke.,"OBJECTIVE


To investigate participation restrictions and satisfaction with participation in partners of patients with stroke.
DESIGN


Cross-sectional study.
SETTING


Five rehabilitation centers and 3 hospitals in The Netherlands.
PARTICIPANTS


A consecutive sample of 54 partners of patients with stroke. The patients were participating in a multicenter randomized controlled trial.
INTERVENTIONS


Not applicable.
MAIN OUTCOME MEASURES


Participation restrictions as a result of the patient's stroke and satisfaction with participation measured with the Utrecht Scale for Evaluation of Rehabilitation-Participation.
RESULTS


The number of participation restrictions differed between partners of patients with stroke. The median number of participation restrictions experienced was 2 for the 11 activities assessed. Most participation restrictions were reported regarding paid work, unpaid work, or education, relationship with partner (ie, patient), and going out. Partners were least satisfied regarding going out, sports or other physical exercise, and day trips and other outdoor activities. The participation restrictions and satisfaction with participation were significantly correlated (ρ=0.65; P<.001), although this relation between participation restrictions and satisfaction with participation differed for the various activities. Differences between satisfied partners with participation restrictions and dissatisfied partners concerned anxiety (U=93.0; P=.026), depression (U=81.5, P=.010), and the number of restrictions experienced (U=50.0; P<.001).
CONCLUSIONS


There is great variety in restrictions experienced by partners regarding different activities and in their satisfaction with these activities. Specific assessment is therefore important when supporting partners of patients with stroke.",2020,"The participation restrictions and satisfaction with participation were significantly correlated (ρ=0.65; P<.001), although this relation between participation restrictions and satisfaction with participation differed for the various activities.","['A consecutive sample of 54 partners of patients with stroke', 'Partners of Patients With Stroke', 'partners of patients with stroke', 'Five rehabilitation centers and 3 hospitals in The Netherlands']",[],"['median number of participation restrictions', 'number of participation restrictions', ""patient's stroke and satisfaction with participation measured with the Utrecht Scale for Evaluation of Rehabilitation-Participation"", 'anxiety']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",54.0,0.0592893,"The participation restrictions and satisfaction with participation were significantly correlated (ρ=0.65; P<.001), although this relation between participation restrictions and satisfaction with participation differed for the various activities.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cox', 'Affiliation': 'Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Schepers', 'Affiliation': 'Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University and De Hoogstraat Rehabilitation, Utrecht, The Netherlands; Department of Rehabilitation, Physical Therapy Science & Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: V.P.M.Schepers@umcutrecht.nl.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Ketelaar', 'Affiliation': 'Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van Heugten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, The Netherlands; School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University Medical Center, Maastricht, The Netherlands; Limburg Center for Brain Injury, Maastricht, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Visser-Meily', 'Affiliation': 'Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University and De Hoogstraat Rehabilitation, Utrecht, The Netherlands; Department of Rehabilitation, Physical Therapy Science & Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.09.012']
2031,31788318,"Pharmacokinetic/pharmacodynamic modeling and simulation of dotinurad, a novel uricosuric agent, in healthy volunteers.","This study aimed to investigate the pharmacokinetic and pharmacodynamic (PK/PD) profiles of dotinurad, a novel uricosuric agent, and to construct a PK/PD model to predict serum urate (SUA) levels after dotinurad administration in healthy men. PK/PD model was constructed using single-dose study data considering the physiological features of urate handling. Model validation was performed by comparing the predicted SUA levels with the SUA levels in a multiple-dose study. Dotinurad was absorbed rapidly, and its exposure increased proportionally in the tested dose ranges (0.5-20 mg) after a single-dose administration. The PK model after oral administration was described using a one-compartment model with first-order absorption. Effects on SUA and renal urate excretion of dotinurad increased with dose escalation but were apparently saturable at a dose >5 mg. The simple maximal effect ( E   max ) model was selected as the PD model of dotinurad on renal urate reabsorption, resulting in an estimated  E   max  of 0.51. The plasma concentration at the half-maximal effect of dotinurad was 196 ng/mL. Other PD parameters were calculated from the change in SUA level or urinary excretion of urate before and after dotinurad administration. The predicted SUA levels, using the PK/PD model, were well-fitted with the observed values. The constructed PK/PD model of dotinurad appropriately described the profiles of dotinurad plasma concentrations and SUA level in multiple administration study.",2019,Effects on SUA and renal urate excretion of dotinurad increased with dose escalation but were apparently saturable at a dose >5 mg.,"['healthy volunteers', 'healthy men']",[],"['SUA level or urinary excretion of urate', 'predicted SUA levels', 'SUA and renal urate excretion', 'plasma concentration', 'serum urate (SUA) levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0148654,Effects on SUA and renal urate excretion of dotinurad increased with dose escalation but were apparently saturable at a dose >5 mg.,"[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Motoki', 'Affiliation': 'FUJI YAKUHIN CO., LTD. Saitama Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Igarashi', 'Affiliation': 'FUJI YAKUHIN CO., LTD. Saitama Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Omura', 'Affiliation': 'FUJI YAKUHIN CO., LTD. Saitama Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakatani', 'Affiliation': 'Department of Research, Clinical Trial Center Kitasato University Kitasato Institute Hospital Tokyo Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Iwanaga', 'Affiliation': 'FUJI YAKUHIN CO., LTD. Saitama Japan.'}, {'ForeName': 'Ikumi', 'Initials': 'I', 'LastName': 'Tamai', 'Affiliation': 'Faculty of Pharmaceutical Sciences Institute of Medical, Pharmaceutical and Health Sciences Kanazawa University Kanazawa Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ohashi', 'Affiliation': 'FUJI YAKUHIN CO., LTD. Saitama Japan.'}]",Pharmacology research & perspectives,['10.1002/prp2.533']
2032,31865906,A qualitative study of older adults' perspectives on initiating exercise and mindfulness practice.,"BACKGROUND


Mindfulness practice and exercise are ways by which older adults can improve and maintain their physical, emotional and cognitive health.
METHODS


This single-site qualitative study gathered insights of older adults' perceptions about initiating and maintaining mindfulness and exercise practices. We carried out focus groups with 41 adults aged 65-85 who had recently initiated Mindfulness Based Stress Reduction (MBSR), structured exercise, or their combination as part of participation in a clinical trial. We used a semi-structured interview to ask them open-ended questions regarding the benefits, barriers and facilitators of participating in mindfulness and/or exercise interventions. The interview also included questions regarding translation of these practices into community settings as well as the long-term maintenance potential of these practices.
RESULTS


Older adults indicated that the mindfulness training increased their awareness and self-reflection and fostered a more self-accepting attitude. Furthermore, they improved their self-care habits and reported having better familial and social relationships. The main barrier for both the exercise and Mindfulness group was time management. The social benefits and sense of community were some of the primary motivators for older adults in the exercise and/or MBSR interventions. However, the research on how to motivate older adults to initiate healthy behavioral changes also needs to be answered. The benefits of exercise and MBSR are a motivation in and of themselves, as indicated by some of the participants.
CONCLUSIONS


This study indicates that mindfulness training and exercise can serve as tools to cultivate important health lifestyle qualities among older adults, who are in the midst of mental, social, emotional and physical change. If it were not for the purpose of the research or the incentives provided by the research team, these older adults may have never started the healthy behavioral changes. From the responses, this may indicate that older adults may need more incentives to begin and maintain behavioral changes other than for their own health benefit.",2019,"RESULTS


Older adults indicated that the mindfulness training increased their awareness and self-reflection and fostered a more self-accepting attitude.","['41 adults aged 65-85 who had recently initiated Mindfulness Based Stress Reduction (MBSR), structured exercise, or their combination as part of participation in a clinical trial', 'older adults', 'Older adults']",['mindfulness training'],['awareness and self-reflection and fostered a more self-accepting attitude'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",41.0,0.0195353,"RESULTS


Older adults indicated that the mindfulness training increased their awareness and self-reflection and fostered a more self-accepting attitude.","[{'ForeName': 'Diana C', 'Initials': 'DC', 'LastName': 'Parra', 'Affiliation': 'Program in Physical Therapy, Washington University in St. Louis, School of Medicine, 4444 Forest Park Ave, Campus Box 8502, St. Louis, MO, 63108, USA. parrad@wustl.edu.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'VA San Diego Healthcare System and Department of Psychiatry, University of California, San Diego, 3350 La Jolla Village Drive San Diego, San Diego, CA, 92161, USA.'}, {'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'Van Zandt', 'Affiliation': 'Program in Physical Therapy, Washington University in St. Louis, School of Medicine, 4444 Forest Park Ave, Campus Box 8502, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Ross C', 'Initials': 'RC', 'LastName': 'Brownson', 'Affiliation': 'Prevention Research Center in St. Louis, Brown School at Washington University in St. Louis, 1 Brookings Drive, Campus Box 1196, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Janardan', 'Initials': 'J', 'LastName': 'Abhishek', 'Affiliation': 'Department of Biology, Washington University School of Medicine, Washington University in St. Louis, 1 Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab., 600 S. Taylor Ave., St. Louis, MO, 63110, USA.'}]",BMC geriatrics,['10.1186/s12877-019-1375-9']
2033,31898006,The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy.,"It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.",2020,"In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151.",[],[],"['rates of LOCE', 'Lesion-oriented composite endpoint (LOCE']",[],[],"[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.0899157,"In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151.","[{'ForeName': 'Ruben Y G', 'Initials': 'RYG', 'LastName': 'Tijssen', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura S M', 'Initials': 'LSM', 'LastName': 'Kerkmeijer', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Kraak', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Nassif', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': 'Kalkman', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sotomi', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'E Karin', 'Initials': 'EK', 'LastName': 'Arkenbout', 'Affiliation': 'The Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Auke P J D', 'Initials': 'APJD', 'LastName': 'Weevers', 'Affiliation': 'The Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'NHLI, Imperial College London, London, UK.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.j.wykrzykowska@amc.uva.nl.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-019-01756-w']
2034,31914620,Exercise twice-a-day potentiates markers of mitochondrial biogenesis in men.,"Endurance exercise begun with reduced muscle glycogen stores seems to potentiate skeletal muscle protein abundance and gene expression. However, it is unknown whether this greater signaling responses is due to performing two exercise sessions in close proximity-as a first exercise session is necessary to reduce the muscle glycogen stores. In the present study, we manipulated the recovery duration between a first muscle glycogen-depleting exercise and a second exercise session, such that the second exercise session started with reduced muscle glycogen in both approaches but was performed either 2 or 15 hours after the first exercise session (so-called ""twice-a-day"" and ""once-daily"" approaches, respectively). We found that exercise twice-a-day increased the nuclear abundance of transcription factor EB (TFEB) and nuclear factor of activated T cells (NFAT) and potentiated the transcription of peroxisome proliferator-activated receptor-ɣ coactivator 1-alpha (PGC-1α), peroxisome proliferator-activated receptor-alpha (PPARα), and peroxisome proliferator-activated receptor beta/delta (PPARβ/δ) genes, in comparison with the once-daily exercise. These results suggest that part of the elevated molecular signaling reported with previous ""train-low"" approaches might be attributed to performing two exercise sessions in close proximity. The twice-a-day approach might be an effective strategy to induce adaptations related to mitochondrial biogenesis and fat oxidation.",2020,We found that exercise twice-a-day increased the nuclear abundance of transcription factor EB (TFEB) and nuclear factor of activated T cells (NFAT) and potentiated the transcription of peroxisome proliferator-activated receptor-ɣ coactivator 1-alpha,['men'],"['muscle glycogen-depleting exercise and a second exercise session, such that the second exercise session started with reduced muscle glycogen', 'Endurance exercise']",['nuclear abundance of transcription factor EB (TFEB) and nuclear factor of activated T cells (NFAT'],"[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C1448629', 'cui_str': 'TFEB protein, human'}, {'cui': 'C0213011', 'cui_str': 'NFAT Proteins'}]",,0.0182457,We found that exercise twice-a-day increased the nuclear abundance of transcription factor EB (TFEB) and nuclear factor of activated T cells (NFAT) and potentiated the transcription of peroxisome proliferator-activated receptor-ɣ coactivator 1-alpha,"[{'ForeName': 'Victor Amorim', 'Initials': 'VA', 'LastName': 'Andrade-Souza', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Thaysa', 'Initials': 'T', 'LastName': 'Ghiarone', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Sansonio', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Kleiton Augusto', 'Initials': 'KA', 'LastName': 'Santos Silva', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Tomazini', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Lucyana', 'Initials': 'L', 'LastName': 'Arcoverde', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Fyfe', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Perri', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Carol Gois', 'Initials': 'CG', 'LastName': 'Leandro', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}, {'ForeName': 'David John', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Adriano Eduardo', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitória de Santo Antão, PE, Brazil.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201901207RR']
2035,32639373,"Validity, Reliability, and Sensitivity to Exercise-Induced Fatigue of a Customer-Friendly Device for the Measurement of the Brain's Direct Current Potential.","Valenzuela, PL, Sánchez-Martínez, G, Torrontegi, E, Vázquez-Carrión, J, Montalvo, Z, and Kara, O. Validity, reliability, and sensitivity to exercise-induced fatigue of a customer-friendly device for the measurement of the brain's direct current potential. J Strength Cond Res XX(X): 000-000, 2020-This study aimed to determine the validity, reliability, and sensitivity to exercise-induced fatigue of the brain's direct current (DC) potential measured with a commercially available and customer-friendly electroencephalography (EEG) device and Omegawave (OW). The study was composed of 3 different experiments as follows: (a) we compared the DC potential values obtained simultaneously in 31 subjects with both OW and a research-quality EEG system; (b) 3 consecutive DC potential measurements with OW were taken at rest on the same day in 25 subjects for reliability analyses; and (c) sensitivity to fatigue was assessed in 9 elite badminton players through the measurement of the DC potential with OW-as well as other fatigue-related measures (e.g., Hooper's index, heart rate variability, jump ability, and simple and complex reaction times)-24 hours after both a day of rest and of strenuous exercise, which were performed in a crossover and randomized design. The DC potential measured with OW was reliable (intraclass correlation coefficient = 0.97) and significantly correlated to that of EEG (r = 0.55, p = 0.001), although significant differences were observed between systems (p < 0.001). Compared with the rest day, strenuous exercise resulted in an impaired Hooper's index (p = 0.010) and jump ability (p = 0.008), longer simple (p = 0.038) and complex reaction times (p = 0.011), and a trend toward sympathetic dominance (standard deviation of normal to normal R-R intervals, p = 0.042; root mean square of differences between consecutive R-R intervals, p = 0.068). In turn, no significant differences were found between sessions for the DC potential (p = 0.173). In summary, the DC potential measured with OW was reliable and modestly correlated to that measured with EEG, but no differences were observed in response to the delayed fatigue (after 24 hours) elicited by strenuous exercise in elite athletes.",2020,"Compared with the rest day, strenuous exercise resulted in an impaired Hooper's index (p = 0.010) and jump ability (p = 0.008), longer simple (p = 0.038) and complex reaction times (p = 0.011), and a trend toward sympathetic dominance (standard deviation of normal to normal R-R intervals, p = 0.042;","['31 subjects with both OW and a research-quality EEG system; (b) 3', 'elite athletes']","['J Strength Cond Res XX(X', 'consecutive DC potential measurements with OW']","[""validity, reliability, and sensitivity to exercise-induced fatigue of the brain's direct current (DC) potential measured with a commercially available and customer-friendly electroencephalography (EEG) device and Omegawave (OW"", 'sympathetic dominance', 'Valenzuela, PL, Sánchez-Martínez, G, Torrontegi, E, Vázquez-Carrión, J, Montalvo, Z, and Kara, O. Validity, reliability, and sensitivity to exercise-induced fatigue', 'jump ability', 'DC potential measured with OW', 'Validity, Reliability, and Sensitivity to Exercise-Induced Fatigue of a Customer-Friendly Device', 'delayed fatigue', 'complex reaction times']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",31.0,0.0284657,"Compared with the rest day, strenuous exercise resulted in an impaired Hooper's index (p = 0.010) and jump ability (p = 0.008), longer simple (p = 0.038) and complex reaction times (p = 0.011), and a trend toward sympathetic dominance (standard deviation of normal to normal R-R intervals, p = 0.042;","[{'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sánchez-Martínez', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Elaia', 'Initials': 'E', 'LastName': 'Torrontegi', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Vázquez-Carrión', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Zigor', 'Initials': 'Z', 'LastName': 'Montalvo', 'Affiliation': 'Department of Sport and Health, Spanish Agency for Health Protection in Sport (AEPSAD), Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kara', 'Affiliation': 'N.P. Bekhtereva Institute of the Human Brain, Russian Academy of Sciences, St. Petersburg, Russia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003695']
2036,32639375,Acute Effects of Squats Using Elastic Bands on Postactivation Potentiation.,"Peng, H-T, Zhan, D-W, Song, C-Y, Chen, Z-R, Gu, C-Y, Wang, I-L, and Wang, L-I. Acute effects of squats using elastic bands on postactivation potentiation. J Strength Cond Res XX(X): 000-000, 2020-The study aimed to investigate the acute effects of squats using elastic bands at different resistance and recovery time points on postactivation potentiation (PAP). Fifteen male collegiate physical education students volunteered to participate in the study. Subjects were assigned to 6 experimental visits, which consisted of repeated factors that were 2 resistance squats (3 repetition maximum [RM] and 5RM) with elastic bands as intervention and 3 performance tests (countermovement jumps [CMJs], 20-m sprints, and change of direction [COD]). The performance test was measured before the resistance squat (pre-test) and at 15 seconds, 4 minutes, and 8 minutes after the resistance squat (post-tests) on each visit. An AMTI force plate and a set of Optojump sensors were used to obtain ground reaction force data during the CMJs and during the 20-m sprints and COD test, respectively. Repeated-measures two-way analyses of variance were performed for the resistance squats and recovery time points for each dependent variable. The 20-m sprint and COD test times at the 4-minute recovery time point after 3RM and 5RM resistance squatting were shorter than the pre-test values (p < 0.05). The rates of force development at the 4- and 8-minute recovery time points after 5RM resistance squatting were higher than the corresponding pre-test values (p < 0.05). All test performance variables significantly decreased at the 15-second recovery time point (p < 0.05). The use of elastic bands in 3RM and 5RM resistance squatting as a warm-up activity may positively affect PAP to improve sprinting, COD ability, and jump explosiveness at the 4-minute recovery time point.",2020,All test performance variables significantly decreased at the 15-second recovery time point (p < 0.05).,['Fifteen male collegiate physical education students volunteered to participate in the study'],['J Strength Cond Res XX(X'],"['Postactivation Potentiation', '5RM resistance squatting', 'rates of force development']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",15.0,0.0249111,All test performance variables significantly decreased at the 15-second recovery time point (p < 0.05).,"[{'ForeName': 'Hsien-Te', 'Initials': 'HT', 'LastName': 'Peng', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei City, Taiwan.'}, {'ForeName': 'Dai-Wei', 'Initials': 'DW', 'LastName': 'Zhan', 'Affiliation': 'Department of Physical Education and Kinesiology, National Dong Hwa University, Hualien, Taiwan.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Song', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan.'}, {'ForeName': 'Zong-Rong', 'Initials': 'ZR', 'LastName': 'Chen', 'Affiliation': 'Department of Athletic Performance, National University of Kaohsiung, Kaohsiung, Taiwan.'}, {'ForeName': 'Chin-Yi', 'Initials': 'CY', 'LastName': 'Gu', 'Affiliation': 'Department of Education and Human Potentials Development, National Dong Hwa University, Hualien, Taiwan.'}, {'ForeName': 'I-Lin', 'Initials': 'IL', 'LastName': 'Wang', 'Affiliation': 'Health Technology College, Jilin Sport University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Li-I', 'Initials': 'LI', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education and Kinesiology, National Dong Hwa University, Hualien, Taiwan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003618']
2037,32639376,The Effects of Three Correction Strategies of Errors on the Snatch Technique in 10-12-Year-Old Children: A Randomized Controlled Trial.,"Souissi, MA, Elghoul, Y, Souissi, H, Masmoudi, L, Ammar, A, Hamdi chtourou, and Souissi, N. The effects of three corrections strategies of errors on the snatch technique in 10-12-year-old children: A randomized controlled trial. J Strength Cond Res XX(X): 000-000, 2020-Sports movement correction is one of the major problems for motor control and learning. Therefore, the purpose of the present study was to determine which of the 3 strategies, i.e., the self-observation method with direct instructions (SO-DI), self-observation alone (SO), or the direct instruction (DI), would be useful for correcting errors during the snatch technique. Forty-eight children with 2 months of experience were randomly assigned to one of 4 training conditions: SO-DI, SO, DI, or control. In this study, the experience lasted 15 sessions. Subjects completed the test sessions before (T0) and after (T1) 12 training sessions and a retention test session after 2 weeks (T2). The Kinovea version 0.8.15 software was used to measure the kinematic parameters of weightlifting performance. After the training intervention, the data showed that the SO-DI group registered a greater improvement in all kinematic parameters compared with the SO, DI, and control groups, and this benefit was present 2 weeks later in the retention test (e.g., the horizontal displacement of the bar in the first pull with respect to the starting position [T1 vs. T0: +32.57 ± 6.69%, d = 1.87, p < 0.001; T2 vs. T0: 25.07 ± 11.55%, d = 1.32, p < 0.001] and the horizontal displacement of the bar between the receiving position and the reference line [T1 vs. T0: 24.34 ± 29%, d = 1.17, p < 0.01; T2 vs. T0: 25.53 ± 30.4%, d = 0.99, p < 0.01]). The results of the present study could have practical implications for physical education teachers because, even if practice is required to improve the technique, the effectiveness of the learning process is essential to enhance learner self-efficacy and motivation.",2020,"After the training intervention, the data showed that the SO-DI group registered a greater improvement in all kinematic parameters compared with the SO, DI, and control groups, and this benefit was present 2 weeks later in the retention test (e.g., the horizontal displacement of the bar in the first pull with respect to the starting position [T1 vs. T0: +32.57 ± 6.69%, d = 1.87, p < 0.001; T2 vs. T0: 25.07 ± 11.55%, d = 1.32, p < 0.001] and the horizontal displacement of the bar between the receiving position and the reference line [T1 vs. T0: 24.34 ± 29%, d = 1.17, p < 0.01; T2 vs. T0: 25.53 ± 30.4%, d = 0.99, p < 0.01]).","['Forty-eight children with 2 months of experience', '10-12-Year-Old Children', '10-12-year-old children']","['J Strength Cond Res XX(X', 'direct instructions (SO-DI), self-observation alone (SO), or the direct instruction (DI']","['kinematic parameters', 'horizontal displacement', 'Souissi, MA, Elghoul, Y, Souissi, H, Masmoudi, L, Ammar, A, Hamdi chtourou, and Souissi, N']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",48.0,0.0214005,"After the training intervention, the data showed that the SO-DI group registered a greater improvement in all kinematic parameters compared with the SO, DI, and control groups, and this benefit was present 2 weeks later in the retention test (e.g., the horizontal displacement of the bar in the first pull with respect to the starting position [T1 vs. T0: +32.57 ± 6.69%, d = 1.87, p < 0.001; T2 vs. T0: 25.07 ± 11.55%, d = 1.32, p < 0.001] and the horizontal displacement of the bar between the receiving position and the reference line [T1 vs. T0: 24.34 ± 29%, d = 1.17, p < 0.01; T2 vs. T0: 25.53 ± 30.4%, d = 0.99, p < 0.01]).","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}, {'ForeName': 'Yousri', 'Initials': 'Y', 'LastName': 'Elghoul', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}, {'ForeName': 'Hichem', 'Initials': 'H', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}, {'ForeName': 'Liwa', 'Initials': 'L', 'LastName': 'Masmoudi', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity, Sport and Health, Research Unit, UR18JS01, National Observatory of Sport, Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003707']
2038,32639379,Effect of Augmented Feedback on Velocity Performance During Strength-Oriented and Power-Oriented Resistance Training Sessions.,"Jiménez-Alonso, A, García-Ramos, A, Cepero, M, Miras-Moreno, S, Rojas, FJ, and Pérez-Castilla, A. Effect of augmented feedback on velocity performance during strength-oriented and power-oriented resistance training sessions. J Strength Cond Res XX(X): 000-000, 2020-This study examined the effects of providing instantaneous velocity feedback (knowledge of results [KR]) on velocity maintenance across multiple sets during strength-oriented and power-oriented resistance training (RT) sessions. Seventeen men completed 2 strength-oriented RT sessions (4 sets of 5 repetitions at 75% of 1 repetition maximum [1RM] during the back squat [SQ] and bench press [BP] exercises) in 1 week and 2 power-oriented RT sessions (4 sets of 5 repetitions at 30% of 1RM during the countermovement jump [CMJ] and BP throw [BPT] exercises) in another week. Subjects received verbal velocity performance feedback in 1 session (KR) and no KR was provided in another session. Greater velocities during the 4 sets of both strength-oriented (from 4.6 to 11.6%) and power-oriented (from 1.4 to 3.5%) RT sessions were observed. The increments in velocity performance during the KR condition were greater for the CMJ (2.25 ± 0.14 vs. 2.18 ± 0.17 m·s; 3.0%) than the BPT (2.33 ± 0.13 vs. 2.29 ± 0.16 m·s; 1.7%) and similarly for the SQ (0.59 ± 0.07 vs. 0.55 ± 0.06 m·s; 7.5%) and BP (0.47 ± 0.09 vs. 0.44 ± 0.07 m·s; 7.8%). The raw differences in the RT velocity for BPT were positively correlated with the raw differences in the RT velocity for SQ (r = 0.524; p = 0.031) and CMJ (r = 0.662; p = 0.004), but the remaining correlations did not reach a statistical significance (r ≤ 0.370; p ≥ 0.123). Although these results support the provision of velocity performance feedback to increase training quality regardless of the type of RT session, the positive effect of KR seems to be more accentuated during strength-oriented compared with power-oriented RT sessions.",2020,"The raw differences in the RT velocity for BPT were positively correlated with the raw differences in the RT velocity for SQ (r = 0.524; p = 0.031) and CMJ (r = 0.662; p = 0.004), but the remaining correlations did not reach a statistical significance (r ≤ 0.370; p ≥ 0.123).","['Seventeen men completed 2', ' 000-000']","['J Strength Cond Res XX(X', 'Augmented Feedback', 'repetition maximum [1RM] during the back squat [SQ] and bench press [BP] exercises) in 1 week and 2 power-oriented RT sessions (4 sets of 5 repetitions at 30% of 1RM during the countermovement jump [CMJ] and BP throw [BPT] exercises', 'strength-oriented and power-oriented resistance training (RT) sessions', 'instantaneous velocity feedback (knowledge of results [KR', 'verbal velocity performance feedback in 1 session (KR) and no KR', 'strength-oriented RT sessions']","['velocity performance', 'Velocity Performance', 'RT velocity for SQ', 'Greater velocities', 'RT velocity for BPT']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022754', 'cui_str': 'Knowledge of Results (Psychology)'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0159584,"The raw differences in the RT velocity for BPT were positively correlated with the raw differences in the RT velocity for SQ (r = 0.524; p = 0.031) and CMJ (r = 0.662; p = 0.004), but the remaining correlations did not reach a statistical significance (r ≤ 0.370; p ≥ 0.123).","[{'ForeName': 'Ainara', 'Initials': 'A', 'LastName': 'Jiménez-Alonso', 'Affiliation': 'Department of Teaching Body Language, Faculty of Educational Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción, Chile.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Cepero', 'Affiliation': 'Department of Teaching Body Language, Faculty of Educational Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Miras-Moreno', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Rojas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003705']
2039,32639465,Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.,"BACKGROUND


We prospectively evaluated efficacy and safety of daptomycin versus active comparator in children with acute hematogenous osteomyelitis (AHO).
METHODS


Randomized, controlled, double-blind, global, multicenter, phase 3 trial. Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy were randomized 1:1 to intravenous daptomycin (once-daily, age-adjusted doses) or comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy (14-42 days total). Primary endpoint: protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences between study arms were evaluated using a prespecified 15% noninferiority margin for daptomycin.
RESULTS


Seventy-three patients per arm received treatment. Pathogens were isolated from 62% of patients (83% methicillin-susceptible Staphylococcus aureus, 9% methicillin-resistant S. aureus [MRSA]). Clinical improvement by Day 5 was observed in 55/71 (78%) daptomycin- and 58/70 (83%) comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4). This difference was not statistically significant; however, daptomycin did not meet the prespecified 15% noninferiority margin, since the lower bound of the 95% CI extended below 15%. Overall, 82% of daptomycin and 87% of comparator patients achieved clinical cure at the test-of-cure visit (secondary endpoint). More comparator patients had treatment-emergent (63% vs. 46%) and treatment-related (18% vs. 7%) adverse events.
CONCLUSIONS


Differences between daptomycin and comparator for the primary endpoint were not statistically significant; however, prespecified noninferiority criteria for daptomycin were not met. With insufficient cases of confirmed MRSA, we could not evaluate daptomycin for MRSA AHO. Our nonvalidated protocol design yields valuable information for implementing future trials in AHO (ClinicalTrials.gov NCT01922011).",2020,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","['Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy', 'children with acute hematogenous osteomyelitis (AHO']","['daptomycin', 'comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy', 'intravenous daptomycin', 'Daptomycin']","['clinical cure', 'protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0027324', 'cui_str': 'Nafcillin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.601159,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Bradley', 'Affiliation': ""From the Division of Infectious Diseases, Rady Children's Hospital San Diego, San Diego, CA.""}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA.""}, {'ForeName': 'Valeri A', 'Initials': 'VA', 'LastName': 'Digtyar', 'Affiliation': ""Dnipropetrovsk Regional Children's Clinical Hospital, Dnipropetrovsk, Ukraine.""}, {'ForeName': 'Myra W', 'Initials': 'MW', 'LastName': 'Popejoy', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Grandhi', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bokesch', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Hershberger', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Tan', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wolf', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mekki', 'Initials': 'M', 'LastName': 'Bensaci', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002790']
2040,32639468,"A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.","OBJECTIVES


To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery.
DESIGN


Prospective, randomized, double-blind, placebo-controlled pharmacokinetic/pharmacodynamics and safety trial.
SETTING


Single-center, postoperative cardiac ICU.
PATIENTS


Children undergoing elective Fontan surgery.
INTERVENTIONS


Subjects randomized on postoperative day number 1 to short-term (3 d) treatment with oral ambrisentan (2.5 mg in suspension, daily) versus placebo (4:1 randomization).
MEASUREMENTS AND MAIN RESULTS


Plasma drug concentrations were measured at 0.5, 1, 2, 4, and 18-36 hours after the first dose. We developed a population pharmacokinetic model in NONMEM 7.2 (Icon Solutions, Ellicott City, MD) and applied the model to dose-exposure simulations. Pharmacodynamics endpoints were assessed at baseline and 3 hours after study drug administration, using postoperative hemodynamic monitoring lines. The analysis included 16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males. There were no differences in baseline characteristics between ambrisentan and controls. A one-compartment model with first-order absorption and lag-time characterized the data well. Allometrically scaled weight was the only covariate retained in the final model. Typical values for clearance and volume of distribution were lower than previously reported in adults, 1 L/hr/70 kg and 13.7 L/70 kg, respectively. Simulated exposures with doses of 0.1-0.2 mg/kg approximated therapeutic exposures in adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses. Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
CONCLUSIONS


Ambrisentan clearance is reduced following Fontan surgery, perhaps reflecting abnormal hepatic metabolism in this population. The observed safety profile appears favorable and hemodynamic effects of ambrisentan may be beneficial for Fontan patients.",2020,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","['Fontan patients', 'adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses', 'children after Fontan surgery', 'Children undergoing elective Fontan surgery', 'Single-center, postoperative cardiac ICU', '16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males']","['Ambrisentan', 'oral ambrisentan (2.5 mg in suspension, daily) versus placebo', 'placebo']","['Fontan pressures', 'Plasma drug concentrations', 'Typical values for clearance and volume of distribution', 'indexed pulmonary vascular resistance', 'plasma brain natriuretic peptide concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.416991,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Anil R', 'Initials': 'AR', 'LastName': 'Maharaj', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Piers C A', 'Initials': 'PCA', 'LastName': 'Barker', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002410']
2041,32639470,A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention.,"OBJECTIVES


Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure.
DESIGN


Patient-level, randomized trial.
SETTING


Two university-based, tertiary-care children's hospital PICUs.
PARTICIPANTS


Parents of patients requiring more than 24 hours in the PICU.
INTERVENTIONS


PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.",2020,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","['We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure', ""Two university-based, tertiary-care children's hospital PICUs"", 'Parents of patients requiring more than 24 hours in the PICU']","['navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure', 'informational brochure providing information about PICU procedures, terms, and healthcare providers', 'PICU Navigator-Based Parent Support Intervention']","['percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge', 'Pediatric Family Satisfaction', 'decision-making satisfaction scores', 'parental psychologic and physical morbidity and perceptions of team communication', 'parental satisfaction or psychologic morbidity']","[{'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",382.0,0.172012,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","[{'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Frader', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Charleston', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rychlik', 'Affiliation': ""Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Danica Y', 'Initials': 'DY', 'LastName': 'Aniciete', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Division of Biostatistics, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Sorce', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Marla L', 'Initials': 'ML', 'LastName': 'Clayman', 'Affiliation': 'Health and Social Development, American Institutes for Research, Chicago, IL.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""Department of Pediatrics, Section of Critical Care, The University of Chicago Comer Children's Hospital, Chicago, IL.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fragen', 'Affiliation': 'Normal Moments, Chicago, IL.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Malakooti', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Derrington', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Program in Ethics and Decision Making in Critical Illness, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002378']
2042,32639484,The effects of intensive speech treatment on intelligibility in Parkinson's disease: A randomised controlled trial.,"Background


More than 6,000,000 individuals worldwide are diagnosed with Parkinson's disease (PD). Nearly 90% develop speech signs that may substantially impair their speech intelligibility, resulting in losses in their communication and quality of life. Benefits of intensive speech treatment have been documented for a range of speech signs. However, the critical question of whether speech is more intelligible after treatment has not been investigated in a randomised controlled trial (RCT). We hypothesised that intensive speech treatment would improve speech intelligibility in PD.
Method


Sixty-four patients with hypokinetic dysarthria secondary to PD participated in this single-centre, parallel arm, statistically-powered RCT. Reporting follows CONSORT guidelines for non-pharmacological treatment. Patients were recruited from US clinics and randomised using a statistician-derived minimisation algorithm, to intensive speech treatment (16 1-hour sessions/1 month) targeting voice (voice group) or targeting articulation (articulation group) or to an untreated group (no treatment group). Speech treatments were delivered by speech clinicians who specialised in treating patients with PD. Trial design minimised bias and supported equipoise. For intelligibility assessment, blinded listeners ( n  = 117) orthographically transcribed 57 patients' recorded, self-generated narrative speech samples, randomly presented in multi-talker babble noise. Listeners were American-English speakers, ages 18-35 years, with normal hearing. The primary outcome was baseline (pre-treatment) to post-treatment change in transcription accuracy (TA), recognised as the most objective measure of intelligibility. TA was defined as the percentage of words transcribed correctly. Listeners, data collectors, and data managers were blinded to treatment conditions and groups. Reliability was evaluated using intraclass correlation coefficients and differences amongst groups were evaluated by mixed-effects models, in accordance with the intention-to-treat approach.This trial was registered with ClinicalTrials.gov Identifier: NCT00123084.
Findings


Between June 23, 2016 and August 14, 2017, blinded listeners transcribed baseline and post-treatment speech samples for intelligibility assessment of 57 patients in the voice ( n  = 19), articulation ( n  = 19) and no treatment ( n  = 19) groups. Between-group differences (d) in changes from baseline to post-treatment in TA indicated significantly greater increases following treatment targeting voice than treatment targeting articulation ( d  = 26·2%, 95% CI 1·5 - 51·0;  p  = 0·04; ES=1·0). Differences between TA changes in the treatment targeting voice and in the no treatment group were significant ( d  = 42·8%, 95% CI 22·4 - 63·2;  p  = 0·0002; ES=1·8). Differences between TA changes in the treatment targeting articulation and in the no treatment group were not significant ( d  = 16·5%, 95% CI -6·1 - 39·2;  p  = 0·147; ES=0·9).
Interpretation


These findings provide the first RCT evidence that intensive speech treatment targeting voice improves speech intelligibility in PD. Thus, this evidence-based treatment may positively impact health-related quality of life for patients with PD globally when it is included in patient management.
Funding


",2020,"Differences between TA changes in the treatment targeting voice and in the no treatment group were significant ( d  = 42·8%, 95% CI 22·4 - 63·2;  p  = 0·0002; ES=1·8).","[""6,000,000 individuals worldwide are diagnosed with Parkinson's disease (PD"", ""Parkinson's disease"", 'Findings\n\n\nBetween June 23, 2016 and August 14, 2017', '57 patients in the voice ( n \xa0=\xa019), articulation ( n \xa0=\xa019) and no treatment ( n \xa0=\xa019) groups', 'Listeners were American-English speakers, ages 18-35 years, with normal hearing']","['intensive speech treatment', 'statistician-derived minimisation algorithm, to intensive speech treatment (16 1-hour sessions/1 month) targeting voice (voice group) or targeting articulation (articulation group) or to an untreated group (no treatment group']","['speech intelligibility, resulting in losses in their communication and quality of life', 'speech intelligibility', 'baseline (pre-treatment) to post-treatment change in transcription accuracy (TA), recognised as the most objective measure of intelligibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0334957', 'cui_str': 'Statistician'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}]",64.0,0.212684,"Differences between TA changes in the treatment targeting voice and in the no treatment group were significant ( d  = 42·8%, 95% CI 22·4 - 63·2;  p  = 0·0002; ES=1·8).","[{'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Levy', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, United States.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moya-Galé', 'Affiliation': 'Department of Communication Sciences and Disorders, Long Island University, Brooklyn, NY, United States.'}, {'ForeName': 'Young Hwa M', 'Initials': 'YHM', 'LastName': 'Chang', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Department of Biomedical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Forrest', 'Affiliation': 'Department of Speech and Hearing Sciences, Indiana University, Bloomington, IN, United States.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Department of Neurology, University of California, Irvine, Allergan LLC, Irvine, CA, United States.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Ramig', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100429']
2043,32639485,Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study.,"Background


Women living with HIV (WLWH) are at higher risk of acquisition and progression of human papillomavirus (HPV) infection. Evidence on effect of HPV vaccination in this population is limited.
Methods


This phase IV randomized controlled observer-blind study assessed immunogenicity and safety of two HPV vaccines (AS04-HPV-16/18 vs. 4vHPV) given in WLWH (stage 1) and HIV- females aged 15-25 years. Co-primary endpoints were to demonstrate, in WLWH subjects, non-inferiority (and if demonstrated, superiority) of AS04-HPV-16/18 vs. 4vHPV for HPV-16 and HPV-18 by pseudovirion-based neutralization assay (PBNA) at month 7 and safety. Non-inferiority criteria was lower limit (LL) of the 95% confidence interval (CI) of the GMT ratio AS04-HPV-16/18/4vHPV above 0.5, in the according to protocol population. NCT01031069.
Findings


Among 873 subjects recruited between 26-Oct-2010 and 14-May-2015, 546 were randomized (1:1) and received at least one vaccine dose (total vaccinated cohort, TVC): 257 were WLWH (129 AS04-HPV-16/18; 128 4vHPV) and 289 were subjects without HIV (144 AS04-HPV-16/18; 145 4vHPV). Baseline CD4 cell count in WLWH was at least 350 cells/mm 3 .At month 7, AS04-HPV-16/18 showed immunological superiority to 4vHPV in WLWH. Neutralizing anti-HPV-16 and HPV-18 antibody GMTs were 2·74 (95% CI: 1·83; 4·11) and 7·44 (95% CI: 4·79; 11·54) fold higher in AS04-HPV-16/18 vs. 4vHPV (LL of the GMT ratio >1 in TVC,  p <0·0001), respectively. Similar results were observed by ELISA up to month 24.Solicited local and general symptoms were in line with product labels. The number of reported serious adverse events (SAEs) was balanced throughout the study.
Interpretation


Both vaccines showed an acceptable safety profile in all subjects. Despite the absence of an immunological correlate of protection for HPV, differences in immune responses elicited by the vaccines especially for HPV-18 may translate into longer lasting or more robust protection against cervical cancer with the AS04-HPV-16/18 vaccine in WLWH.",2020,"Despite the absence of an immunological correlate of protection for HPV, differences in immune responses elicited by the vaccines especially for HPV-18 may translate into longer lasting or more robust protection against cervical cancer with the AS04-HPV-16/18 vaccine in WLWH.","['WLWH (stage 1) and HIV- females aged 15-25 years', '873 subjects recruited between 26-Oct-2010 and 14-May-2015', 'asymptomatic young women living with HIV aged 15-25 years', '\n\n\nWomen living with HIV (WLWH']","['AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines', 'vaccine dose (total vaccinated cohort, TVC): 257 were WLWH', 'HPV vaccination', 'HPV vaccines (AS04-HPV-16/18\u202fvs. 4vHPV']","['Baseline CD4 cell count in WLWH', 'Immunogenicity and safety', 'immunogenicity and safety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",873.0,0.343726,"Despite the absence of an immunological correlate of protection for HPV, differences in immune responses elicited by the vaccines especially for HPV-18 may translate into longer lasting or more robust protection against cervical cancer with the AS04-HPV-16/18 vaccine in WLWH.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Folschweiller', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Teixeira', 'Affiliation': 'University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Jehangir Clinical Development Centre and Prayas, Pune, India.'}, {'ForeName': 'Luciano Z', 'Initials': 'LZ', 'LastName': 'Goldani', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre Brazil.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Chittaranjan National Cancer Institute, Kolkata, India.'}, {'ForeName': 'Tawee', 'Initials': 'T', 'LastName': 'Chotpitayasunondh', 'Affiliation': 'Queen Sirikit National Institute of Child Health, Bangkok, Thailand.'}, {'ForeName': 'Ploenchan', 'Initials': 'P', 'LastName': 'Chetchotisakd', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University and HIVNAT, TRC-ARC, Bangkok, Thailand.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Roteli-Martins', 'Affiliation': 'ABC Medical School, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Instituto de pesquisa Clínica Evandro Chagas (IPEC), Rio de Janeiro, Brazil.'}, {'ForeName': 'Silvana Maria', 'Initials': 'SM', 'LastName': 'Quintana', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Selvamuthu', 'Initials': 'S', 'LastName': 'Poongulali', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Kulkarni', 'Affiliation': 'Jehangir Clinical Development Centre and Prayas, Pune, India.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Sanjoy K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'GSK, Singapore, Singapore.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Descamps', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Dodet', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Friel', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hezareh', 'Affiliation': 'Chiltern international for GSK, Wavre, Belgium.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Meric Camilleri', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Sylviane', 'Initials': 'S', 'LastName': 'Poncelet', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Salaun', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tavares-da-Silva', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Thomas-Jooris', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100353']
2044,32639518,Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial.,"Importance


Although lipoprotein(a) (Lp[a]) is a causal genetic risk factor for atherosclerotic cardiovascular disease, it remains unclear which patients with established atherosclerotic cardiovascular disease stand to benefit the most from Lp(a) lowering. Whether inflammation can modulate Lp(a)-associated cardiovascular (CV) risk during secondary prevention is unknown.
Objective


To examine whether Lp(a)-associated CV risk is modulated by systemic inflammation in optimally treated patients at high risk of CV disease.
Design, Setting, and Participants


A prespecified secondary post hoc analysis of the double-blind, multicenter randomized clinical Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015. The study was conducted at 543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment. Statistical analysis for this post hoc analysis was performed from September 26, 2018, to March 28, 2020.
Interventions


Participants received evacetrapib, 130 mg/d, or matching placebo.
Main Outcomes and Measures


The ACCELERATE trial found no significant benefit or harm of evacetrapib on 30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina). This secondary analysis evaluated rates of CV death, MI, and stroke across levels of Lp(a).
Results


High-sensitivity C-reactive protein and Lp(a) levels were measured in 10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years). In fully adjusted analyses, in patients with hsCRP of 2 mg/L or more but not less than 2 mg/L, increasing quintiles of Lp(a) were significantly associated with greater rates of death, MI, and stroke (P = .006 for interaction). Each unit increase in log Lp(a) levels was associated with a 13% increased risk of CV death, nonfatal MI, or stroke only in those with hsCRP levels of 2 mg/L or more (P = .008 for interaction). There was also a significant stepwise relationship between increasing Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P < .001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
Conclusions and Relevance


Elevated Lp(a) levels during treatment are related to CV death, MI, and stroke when hsCRP levels are 2 mg/L or more but not less than 2mg/L. This finding suggests a potential benefit of lowering Lp(a) in patients with residual systemic inflammation despite receipt of optimal medical therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT01687998.",2020,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","['Optimally Treated Patients With High-Risk Vascular Disease', '10 503 patients (8135 men; 8561 white; 10 134 received concurrent statins; mean [SD] age, 64.6 [9.4] years', 'Patients at a High Risk for Vascular Outcomes (ACCELERATE) trial was conducted between October 1, 2012, and December 31, 2013; the study was terminated October 12, 2015', '543 academic and community hospitals in 36 countries among 12 092 patients at high risk of CV disease (acute coronary syndrome, stroke, peripheral arterial disease, or type 2 diabetes with coronary artery disease) with measurable Lp(a) and high-sensitivity C-reactive protein (hsCRP) levels during treatment', 'patients with residual systemic inflammation despite receipt of optimal medical therapy', 'optimally treated patients at high risk of CV disease', 'patients with established atherosclerotic cardiovascular disease']","['C-Reactive Protein', 'lipoprotein(a) (Lp[a', 'Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib', 'evacetrapib, 130 mg/d, or matching placebo']","['30-month major adverse cardiovascular events (CV death, myocardial infarction [MI], stroke, coronary revascularization, or hospitalization for unstable angina', 'quintiles of Lp(a', 'hsCRP levels', 'Lipoprotein(a)-Associated Cardiovascular Risk', 'log Lp(a', 'High-sensitivity C-reactive protein and Lp(a) levels', 'rates of CV death, MI, and stroke across levels of Lp(a', 'Lp(a) quintiles and time to first CV death, MI, or stroke (log-rank P\u2009', 'rates of death, MI, and stroke', 'risk of CV death, nonfatal MI, or stroke']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",12092.0,0.296263,".001) when hsCRP levels were 2 mg/L or more but not less than 2 mg/L. Sensitivity analyses in the ACCELERATE placebo-treated group yielded similar significant associations exclusively in the group with hsCRP of 2 mg/L or more.
","[{'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Benoit J', 'Initials': 'BJ', 'LastName': 'Arsenault', 'Affiliation': 'Québec Heart & Lung Institute, Université de Laval, Québec, Québec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'St John', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Ruotolo', 'Affiliation': 'Eli Lilly, Indianapolis, Indiana.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McErlean', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'MonashHeart, Department of Cardiology, Monash University, Clayton, Victoria, Australia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.2413']
2045,32639545,Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial.,"Importance


Gynecological laparoscopies are one of the most common surgical procedures worldwide. Limited evidence exists on rates of surgical site infections in patients undergoing gynecological laparoscopies and strategies to prevent these infections.
Objective


To compare rates of port-site infections, organ or space infections, and any type of surgical site infections among patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions.
Design, Setting, and Participants


A double-blind randomized clinical trial was conducted between February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center. A total of 661 patients 18 years or older who underwent an elective operative laparoscopy for treatment of nonmalignant gynecological disorders were randomly assigned in a 1:1:1 ratio to have their skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine. Statistical analysis was performed from February 28, 2017, to November 26, 2018. Analyses were performed on a modified intention-to-treat basis.
Interventions


A total of 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. The patients were blinded to the solution used to clean their skin. Patients were followed up 1 and 4 weeks after surgery by a physician who was blinded to the skin preparation solution used at surgery. Evidence of infection according to Centers for Disease Control and Prevention criteria were documented.
Main Outcomes and Measures


The primary outcome of this study was port-site infection 30 days after surgery. Secondary outcomes were organ or space infections and any type of surgical site infections; the study also aimed to prospectively describe rates of surgical site infections in gynecological laparoscopies.
Results


Of the 661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis. The overall rate of port-site infection was 10.2% (65 of 640), rate of organ or space infection was 6.6% (42 of 640), and rate of any surgical site infection was 16.3% (104 of 640). The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
Conclusions and Relevance


Surgical site infections were more common than expected among patients who underwent gynecological laparoscopies. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.
Trial Registration


http://anzctr.org.au Identifier: ACTRN12617000475347.",2020,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","['patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions', 'February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center', '661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis', 'Patients', 'patients who underwent gynecological laparoscopies', 'patients undergoing gynecological laparoscopies', '221 patients were randomized to have their skin prepared preoperatively with', '661 patients 18 years or older who underwent an', 'for treatment of nonmalignant gynecological disorders']","['Surgical Skin Antisepsis', 'Gynecological Laparoscopic Surgery', 'water-based povidone-iodine', 'alcohol-based chlorhexidine', 'elective operative laparoscopy', 'povidone-iodine vs alcohol-based povidone-iodine', 'alcohol-based povidone-iodine', 'chlorhexidine vs alcohol-based povidone-iodine', 'chlorhexidine vs water-based povidone-iodine', 'skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine']","['surgical site infections in gynecological laparoscopies', 'overall rate of port-site infection', 'Surgical Site Infections', 'infection rates', 'rate of any surgical site infection', 'organ or space infections and any type of surgical site infections', 'rate of organ or space infection', 'odds ratio for port-site infection', 'rates of port-site infections, organ or space infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",221.0,0.146845,"The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).
","[{'ForeName': 'Uri P', 'Initials': 'UP', 'LastName': 'Dior', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Shamitha', 'Initials': 'S', 'LastName': 'Kathurusinghe', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Reddington', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': ""Department of Microbiology and Infectious Disease, The Royal Women's Hospital, Parkville, Australia.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Healey', 'Affiliation': ""Gynaecology Division, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",JAMA surgery,['10.1001/jamasurg.2020.1953']
2046,32639561,Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder: A Randomized Clinical Trial.,"Importance


Despite evidence of efficacious psychological and pharmacologic therapies for insomnia, there is little information about what first-line treatment should be and how best to proceed when initial treatment fails.
Objective


To evaluate the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia and examine the moderating effect of psychiatric disorders on insomnia outcomes.
Design, Setting, and Participants


In a sequential multiple-assignment randomized trial, patients were assigned to first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]). The study took place at Institut Universitaire en Santé Mentale de Québec, Université Laval, Québec City, Québec, Canada, and at National Jewish Health, Denver, Colorado, and enrollment of patients took place from August 2012 through July 2017.
Main Outcomes and Measures


The primary end points were the treatment response and remission rates, defined by the Insomnia Severity Index total score.
Results


Patients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65). Second-stage therapy produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) but no significant change following zolpidem treatment. Significant increase in percentage of remitters was observed in 2 of 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00). Although response/remission rates were lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone yielded better outcomes for patients with comorbid insomnia. Response and remission rates were well sustained through the 12-month follow-up.
Conclusions and Relevance


Behavioral therapy and zolpidem medication produced equivalent response and remission rates. Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies.
Trial Registration


ClinicalTrials.gov Identifier: NCT01651442.",2020,"First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%;","['patients with comorbid insomnia', 'Insomnia Disorder', 'Results\n\n\nPatients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder']","['behavioral therapy (BT; n\u2009=\u2009104) or zolpidem (zolpidem; n\u2009=\u2009107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT', 'trazodone', 'Sequential Psychological and Medication Therapies', 'CT or zolpidem', 'BT or zolpidem', 'zolpidem']","['response/remission rates', 'equivalent response and remission rates', 'treatment response and remission rates, defined by the Insomnia Severity Index total score', 'Response and remission rates', 'percentage of remitters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",74.0,0.059307,"First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%;","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Beaulieu-Bonneau', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guay', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Bélanger', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cartwright', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Lamy', 'Affiliation': 'École de psychologie, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Busby', 'Affiliation': 'University of Colorado, Denver.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1767']
2047,32639592,Effects of a mindfulness-based intervention on cancer-related cognitive impairment: Results of a randomized controlled functional magnetic resonance imaging pilot study.,"BACKGROUND


Many breast cancer survivors suffer from cognitive complaints after cancer treatment, affecting their quality of life. The objective of this pilot study was to investigate the effect of a blended-care mindfulness-based intervention (MBI) on chemotherapy-related cognitive impairment and functional brain changes. Furthermore, correlations between changes in cognitive functioning and self-reported behavioral factors were investigated.
METHODS


Breast cancer survivors (n = 33) who reported cognitive impairment were randomly allocated to a mindfulness condition (n = 18) or a waitlist control condition (n = 15). Patients completed questionnaires on cognitive impairment, emotional distress, and fatigue; neuropsychological tests; and resting-state functional magnetic resonance imaging before the start of MBI (time 1 [T1]), immediately after the completion of an 8-week MBI program (T2), and 3 months postintervention (T3). Resting-state functional connectivity was estimated in the default mode network, the dorsal and salience attention networks, and the frontoparietal network. Mixed model repeated-measures analysis was performed to test the intervention effect.
RESULTS


Patients in the mindfulness condition exhibited significantly higher connectivity between the dorsal and salience attention networks after the mindfulness intervention compared with those in the control condition. MBI participants also had reduced subjective cognitive impairment, emotional distress, and fatigue. No intervention effect was observed on neurocognitive tests.
CONCLUSIONS


MBI may induce functional brain changes in networks related to attention and may have a positive effect on subjective measures of cognitive impairment in breast cancer survivors. Therefore, MBI could be a suitable intervention to improve quality of life in this population and deserves further study in this context.",2020,"RESULTS


Patients in the mindfulness condition exhibited significantly higher connectivity between the dorsal and salience attention networks after the mindfulness intervention compared with those in the control condition.","['breast cancer survivors', 'Breast cancer survivors (n\xa0=\xa033) who reported cognitive impairment', 'cancer-related cognitive impairment']","['blended-care mindfulness-based intervention (MBI', 'mindfulness condition (n\xa0=\xa018) or a waitlist control condition', 'mindfulness-based intervention']","['quality of life', 'cognitive functioning and self-reported behavioral factors', 'dorsal and salience attention networks', 'Resting-state functional connectivity', 'cognitive impairment, emotional distress, and fatigue; neuropsychological tests; and resting-state functional magnetic resonance imaging', 'subjective cognitive impairment, emotional distress, and fatigue', 'neurocognitive tests']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}]",33.0,0.0464252,"RESULTS


Patients in the mindfulness condition exhibited significantly higher connectivity between the dorsal and salience attention networks after the mindfulness intervention compared with those in the control condition.","[{'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Van der Gucht', 'Affiliation': 'Leuven Mindfulness Center, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Soumaya', 'Initials': 'S', 'LastName': 'Ahmadoun', 'Affiliation': 'Department of Imaging and Pathology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melis', 'Affiliation': 'Department of Imaging and Pathology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'de Cloe', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sleurs', 'Affiliation': 'Department of Pediatric Oncology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Radwan', 'Affiliation': 'Department of Imaging and Pathology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Blommaert', 'Affiliation': 'Department of Gynecologic Oncology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Psychology, Ludwig-Maximilians Munich University, Munich, Germany.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Vandenbulcke', 'Affiliation': 'Department of Neurosciences, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Multidisciplinary Breast Center, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Center, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kuppens', 'Affiliation': 'Leuven Mindfulness Center, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Leuven Mindfulness Center, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Smeets', 'Affiliation': 'Multidisciplinary Breast Center, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sunaert', 'Affiliation': 'Department of Imaging and Pathology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Deprez', 'Affiliation': 'Department of Imaging and Pathology, Catholic University of Leuven, Leuven, Belgium.'}]",Cancer,['10.1002/cncr.33074']
2048,32639610,Long Term Outcomes of Anterior Cruciate Ligament Reconstruction Surgery: 2020 OREF Clinical Research Award Paper.,"ACL injuries place the knee at risk for post-traumatic osteoarthritis (PTOA) despite surgical ACL reconstruction (ACLR). One parameter thought to affect PTOA risk is the initial graft tension. This randomized controlled trial (RCT) was designed to compare outcomes between two graft tensioning protocols that bracket the range commonly used. At 7-years post-surgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in the both groups relative to controls. The trial database was also leveraged to gain insight into mechanisms of PTOA following ACL injury. We determined that the inflammatory response at the time of injury undermines one of the joint's lubricating mechanisms. We learned that patients continue to protect their surgical knee 5 years post-injury compared to controls during a jump-pivot activity. We also established that pre-surgical knee function and mental health were correlated with symptomatic PTOA at 7-years, that there were specific anatomical factors associated with poor outcomes, and that there were no changes in outcomes due to tunnel widening in patients receiving hamstring tendon autografts. We also validated an MRI technique to non-invasively assess graft strength. In conclusion, the RCT determined that initial graft tensioning does not have a major influence on 7-year outcomes. Therefore, surgeons can reconstruct the ACL using a graft tensioning protocol that is within the window of the two graft tensioning techniques evaluated in this RCT. This article is protected by copyright. All rights reserved.",2020,"At 7-years post-surgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in the both groups relative to controls.",['patients receiving hamstring tendon autografts'],"['surgical ACL reconstruction (ACLR', 'Anterior Cruciate Ligament Reconstruction Surgery']",['pre-surgical knee function and mental health'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0307706,"At 7-years post-surgery, we determined that most outcomes between the two tension groups were not significantly different, that they were inferior to an uninjured matched control group, and that PTOA was progressing in the both groups relative to controls.","[{'ForeName': 'Braden C', 'Initials': 'BC', 'LastName': 'Fleming', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Fadale', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hulstyn', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Shalvoy', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Tung', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Badger', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24794']
2049,32639634,Caffeine citrate maintenance doses effect on extubation and apnea post-ventilation in preterm infants.,"BACKGROUND


Caffeine citrate is used to prevent apnea in premature infants and help in extubation of invasive ventilation, but the optimal dose remains undetermined.
METHODS


Neonates born at less than 30 weeks gestation who had received invasive ventilation for at least 48 hours and a loading dose of 20 mg/kg caffeine citrate, were randomly assigned into high (10 mg/kg daily) or low (5 mg/kg daily) maintenance dose groups. The drug was discontinued if no apnea occurred for seven consecutive days.
RESULTS


A total of 111 infants were assigned into the high (54) or low (57) dose groups. Extubation failure (16.7% vs 36.8%), age of extubation (8.2±2.1d vs 10.7±2.3d), duration of invasive ventilation (7.2±2.1d vs 8.5±2.4d), duration of ventilation before extubation (8.0±1.8d vs 10.1±1.9d), and number of days of apnea (1.8±1.3d vs 3.2±1.1d) were significantly lower in the high dose group than the low dose group. Difference in time until failure (6.7±1.7d vs 7.0±1.9d) and duration of nasal continuous positive airway pressure(7.8±1.8d vs 8.0±2.2d) were not significant. Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%) or irritability (7.4% vs 5.3%) were observed between groups.
CONCLUSIONS


A higher maintenance dose of caffeine citrate reduced the incidence of extubation failure and apnea of prematurity without increasing the occurrence of adverse reactions. This article is protected by copyright. All rights reserved.",2020,"Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%) or irritability (7.4% vs 5.3%) were observed between groups.
","['Neonates born at less than 30 weeks gestation who had received invasive ventilation for at least 48 hours and a loading dose of 20 mg/kg', 'preterm infants', 'A total of 111 infants were assigned into the high (54) or low (57) dose groups']","['Caffeine citrate maintenance', 'Caffeine citrate', 'caffeine citrate']","['incidence of tachycardia', 'time until failure', 'abdominal distension', 'feeding intolerance', 'duration of invasive ventilation', 'extubation and apnea post-ventilation', 'duration of ventilation before extubation', 'age of extubation', 'irritability', 'duration of nasal continuous positive airway', 'number of days of apnea', 'incidence of extubation failure and apnea of prematurity', 'Extubation failure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}]",111.0,0.0582797,"Furthermore, no significant differences in the incidence of tachycardia (9.3% vs 12.3%), abdominal distension (16.7% vs 12.3%), feeding intolerance (3.7% vs 5.3%) or irritability (7.4% vs 5.3%) were observed between groups.
","[{'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Pediatrics,, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Neonatology,, Children's Medical Center, Hunan Provincial People's Hospital / The first Affiliated Hospital of Hunan Normal University, Changsha, Hunan, 410005, P.R. China.""}, {'ForeName': 'Pingyang', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics,, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, P.R. China.'}]",Pediatric pulmonology,['10.1002/ppul.24948']
2050,32639645,"Effects of thoracic nerve block on perioperative lung injury, immune function, and recovery after thoracic surgery.","BACKGROUND


To investigate the effects of thoracic nerve block on perioperative lung injury, immune function, and recovery after thoracic surgery METHODS: A total of 120 patients with lung cancer were randomly allocated into three groups: general anesthesia group (GAL group), thoracic paravertebral nerve block (TPVB) combined with general anesthesia (TPL group), and TPVB (with paravertebral dexmedetomidine) combined with general anesthesia group (TDL group); 120 patients with esophageal cancer were randomly allocated into three groups: general anesthesia group (GAE group), TPVB combined with general anesthesia group (TPE group), and thoracic epidural block combined with general anesthesia group (TEE group). Lung injury and immune function were evaluated. Hemodynamic changes, early recovery in post-anesthesia care unit, pain, 6-min walking test (6MWT), drug consumption, and life quality were also observed. The duration in the PACU of patients was retrospectively analyzed. The effect of dexmedetomidine on lung injury was established in vitro.
RESULTS


The lung injury, including injury scores, apoptosis, and inflammation, were decreased in the TDL group compared with the GAL group and TPL group. The ratio of CD4 +  /CD8 +  cells at the end of surgery was higher in the TPE group than in the GAE group. More stable hemodynamic was found in TPL group and TPE group. Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine. Anesthetic consumption was decreased by thoracic nerve block.
CONCLUSIONS


Thoracic nerve block, especially TPVB with or without paravertebral dexmedetomidine, can enhance recovery after thoracic surgery. Protection against independent lung injury and cellular immune dysfunction may be a potential mechanism.",2020,Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine.,"['group); 120 patients with esophageal cancer', '120 patients with lung cancer']","['TPL', 'Thoracic nerve block, especially TPVB with or without paravertebral dexmedetomidine', 'TPE', 'general anesthesia group (GAL group), thoracic paravertebral nerve block (TPVB) combined with general anesthesia (TPL group), and TPVB (with paravertebral dexmedetomidine) combined with general anesthesia group (TDL', 'thoracic nerve block', 'GAL', 'dexmedetomidine', 'general anesthesia group (GAE group), TPVB combined with general anesthesia group (TPE group), and thoracic epidural block combined with general anesthesia group (TEE group']","['lung injury, including injury scores, apoptosis, and inflammation', 'Hemodynamic changes, early recovery in post-anesthesia care unit, pain, 6-min walking test (6MWT), drug consumption, and life quality', 'Anesthetic consumption', 'Lung injury and immune function', 'Acute pain', 'ratio of CD4 +  /CD8 +  cells', 'perioperative lung injury, immune function, and recovery']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0039983', 'cui_str': 'Structure of thoracic spinal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0394835', 'cui_str': 'Local anesthetic thoracic epidural block'}]","[{'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",120.0,0.0497344,Acute pain was alleviated and the 6MWT was enhanced by TPVB with or without dexmedetomidine.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Xuhui', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Hongfang', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': ""Department of General Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}, {'ForeName': 'Jiaqiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Center for Clinical Single Cell Biomedicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.""}]",Clinical and translational medicine,['10.1002/ctm2.38']
2051,32639649,Trial of Restarting and Tolerating Metformin (TreatMet).,,2020,,[],['Restarting and Tolerating Metformin (TreatMet'],[],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.0175862,,"[{'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Orloff', 'Affiliation': 'Weill Cornell Medicine, Population Health Sciences.'}, {'ForeName': 'Samir H', 'Initials': 'SH', 'LastName': 'Touhamy', 'Affiliation': 'Weill Cornell Medical College.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Truong', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism Comprehensive Weight Control Center, Weill Cornell Medical College.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Casper', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism Comprehensive Weight Control Center, Weill Cornell Medical College.'}, {'ForeName': 'Alpana P', 'Initials': 'AP', 'LastName': 'Shukla', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism Comprehensive Weight Control Center, Weill Cornell Medical College.'}, {'ForeName': 'Leon I', 'Initials': 'LI', 'LastName': 'Igel', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism Comprehensive Weight Control Center, Weill Cornell Medical College.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Flory', 'Affiliation': 'Memorial Sloan Kettering Cancer Center.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14137']
2052,32639688,Evaluation of the recovery outcome of poststroke cognitive impairment after cluster needling of scalp acupuncture therapy based on functional near-infrared spectroscopy.,"BACKGROUND


Cognitive impairment often arises in patients suffered from stroke. Acupuncture is a recommended treatment option for stroke by the World Health Organization (WHO) and has been shown to improve the cognitive function of patients with poststroke cognitive impairment (PSCI).
METHODS


In the present study, we assessed the efficacy of scalp acupuncture with cluster needling on PSCI patients. Fifty six PSCI patients were randomly separated into the reference group who received drug treatment only and the treatment group who received cluster needling of scalp acupuncture on top of drug treatment. Cognitive function was compared between the two groups before and after treatment. We also took the advantage of functional near-infrared spectroscopy to assess the cerebral hemoglobin levels.
RESULTS


We reveal that applying cluster needling of scalp acupuncture on top of drug treatment can significantly improve the cognitive function and elevate the cerebral hemoglobin levels compared to patients treated with drug only.
CONCLUSIONS


Our results suggest that cluster needling of scalp acupuncture is an effective treatment against PSCI and shed light on its application on other neurological disorders.",2020,Cognitive function was compared between the two groups before and after treatment.,"['patients suffered from stroke', 'PSCI patients', 'patients with poststroke cognitive impairment (PSCI', 'Fifty six PSCI patients']","['scalp acupuncture', 'scalp acupuncture with cluster needling', 'Acupuncture', 'scalp acupuncture therapy', 'cluster needling of scalp acupuncture']","['Cognitive function', 'cognitive function', 'cerebral hemoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",56.0,0.0410108,Cognitive function was compared between the two groups before and after treatment.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Jingge', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Heilongjiang University of Traditional Chinese Medicine, Harbin, China.'}]",Brain and behavior,['10.1002/brb3.1731']
2053,32639698,A Pilot Randomized Controlled Crossover Trial Comparing Early OHRQoL Outcomes of Cobalt-Chromium Versus PEEK Removable Partial Denture Frameworks.,"PURPOSE


To investigate differences in the performance of polyether ether ketone (PEEK) frameworks vs traditional metal frameworks for removable partial dentures (RPDs) in terms of OHRQoL, patient preference, periodontal indices, and denture satistfaction.
MATERIALS AND METHODS


Twenty-six participants were recruited to a randomized controlled crossover trial and were provided with either PEEK or cobalt-chromium (Co-Cr) RPDs. After 4 weeks, the participants were provided with the other RPD. After both 4-week testing periods, the participants chose their preferred RPD and were followed up again at 6 months and 1 year. The primary outcome measure was effect on OHIP-20 score, which was compared among patients using repeated measures ANOVA. Secondary outcomes were participant preference compared using chi-square analysis; Plaque Index and Gingival Bleeding Index (PI and GBI, respectively) compared using repeated measures ANOVA; and McGill Denture Satisfaction Questionnaire (MDSQ) score compared between the two 4-week follow-ups using paired-samples t test.
RESULTS


Both Co-Cr and PEEK frameworks resulted in a significant improvement in OHIP-20 score (P < .001), but the material was not a significant factor in changes over 1 year (P = .87). There were no statistically significant differences in participant preference at 1 year (P = .491), nor between RPD materials in their effect on GBI (P = .476), PI (P = .967), or MDSQ (P = .368).
CONCLUSION


Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline. No significant preference or improved denture satisfaction score was seen for either material. PEEK frameworks seem to be associated with similar degrees of periodontal effects as Co-Cr frameworks.",2020,"Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline.","['Versus PEEK Removable Partial Denture Frameworks', 'Twenty-six participants']","['PEEK or cobalt-chromium (Co-Cr) RPDs', 'polyether ether ketone (PEEK) frameworks vs traditional metal frameworks', 'Cobalt-Chromium']","['denture satisfaction score', 'GBI', 'OHIP-20 score', 'OHRQoL', 'participant preference compared using chi-square analysis; Plaque Index and Gingival Bleeding Index (PI and GBI, respectively) compared using repeated measures ANOVA; and McGill Denture Satisfaction Questionnaire (MDSQ) score']","[{'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0450152', 'cui_str': 'Metal framework'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.142266,"Both Co-Cr and PEEK RPDs improved OHRQoL to a degree greater than the minimum clinically important difference at 4 weeks, 6 months, and 1 year compared to baseline.","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Sereno', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.6604']
2054,32634275,Evaluation of 2-Hour Post-Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult-to-Treat Migraine Attacks.,"OBJECTIVE


To identify factors predicting response (2-hour headache pain freedom or most bothersome symptom freedom) to lasmiditan based on individual patient characteristics, migraine disease characteristics, and migraine attack characteristics. Further, efficacy specifically in difficult-to-treat patient/migraine disease characteristics or attack characteristics (ie, historically considered less responsive to certain acute therapies) subgroups was analyzed.
BACKGROUND


Knowledge of factors associated with a positive or negative response to acute treatment would be useful to practitioners prescribing acute treatments for migraine. Additionally, practitioners and patients would benefit from understanding the efficacy of lasmiditan specifically in subgroups of patients with migraine disease characteristics and migraine attack characteristics historically associated with decreased pain threshold, reduced efficacy of acute treatment, or increased burden of migraine.
METHODS


Pooled analyses were completed from 2 Phase 3 double-blind clinical trials, SPARTAN and SAMURAI. Data from baseline to 2 hours after taking lasmiditan (50, 100, or 200 mg) or placebo were analyzed to assess efficacy based on patient characteristics, migraine disease characteristics, and migraine attack characteristics. A total of 3981 patients comprising the intent-to-treat population were treated with placebo (N = 1130), lasmiditan 50 mg (N = 598), lasmiditan 100 mg (N = 1133), or lasmiditan 200 mg (N = 1120). Data were analyzed for the following efficacy measures at 2 hours: headache pain freedom and most bothersome symptom freedom.
RESULTS


None of the analyzed subgroups based on individual patient characteristics, migraine disease characteristics, or migraine attack characteristics predicted headache pain freedom or most bothersome symptom freedom response at 2 hours following lasmiditan treatment (interaction P ≥ .1). For the difficult-to-treat patient/migraine disease characteristics subgroups (defined as those with ≥24 headache days in the past 3 months, duration of migraine history ≥20 years, severe disability [Migraine Disability Assessment score ≥21], obesity [≥30 kg/m 2  ], and history of psychiatric disorder), single doses of lasmiditan (100 or 200 mg) were significantly more effective than placebo (P ≤ .002) in achieving both endpoints. Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan. For the difficult-to-treat migraine attack subgroups, patients with severe headache, co-existent nausea at the time of treatment, or who delayed treatment for ≥2 hours from the time of headache onset, both endpoint response rates after lasmiditan 100 or 200 mg were significantly greater than after placebo. Among those who delayed treatment for ≥4 hours from the time of headache onset, headache pain freedom response rates for the 200 mg dose of lasmiditan met statistical significance vs placebo (32.4% vs 15.9%; odds ratio = 2.7 [1.17, 6.07]; P = .018). While the predictors of response interaction test showed similar efficacy of lasmiditan vs placebo across subgroups defined by baseline functional disability (mild, moderate, or needs complete bed rest) at the time of treatment, analyses of lasmiditan efficacy within the subgroup ""needs complete bed rest"" appeared to show less efficacy (eg, in the 200 mg vs placebo group, 25.9% vs 18.5%; odds ratio = 1.56 [0.96, 2.53]; P = .070).
CONCLUSIONS


Efficacy of lasmiditan 200 and 100 mg for headache pain freedom and most bothersome symptom freedom at 2 hours post-treatment was generally not influenced by the individual patient characteristics, migraine disease history, or migraine attack characteristics that were analyzed. In the analyses of difficult-to-treat subgroups, patients receiving lasmiditan achieved greater responses (2-hour headache pain freedom and most bothersome symptom freedom) vs placebo recipients.",2020,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,['3981 patients comprising the intent-to-treat population'],"['Lasmiditan', 'lasmiditan 50\xa0mg (N\xa0=\xa0598), lasmiditan 100\xa0mg (N\xa0=\xa01133), or lasmiditan 200\xa0mg', 'placebo']","['headache pain freedom or most bothersome symptom freedom response', 'time of headache onset, headache pain freedom response rates', 'Headache pain freedom response rates', 'headache pain freedom and most bothersome symptom freedom', 'headache pain freedom', 'duration of migraine history ≥20\xa0years, severe disability [Migraine Disability Assessment score ≥21], obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",3981.0,0.177233,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,"[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Vasudeva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Vargas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Magis', 'Affiliation': 'Department of Neurology and Headache and Pain Multimodal Management Clinic, CHR East Belgium Hospital, Verviers, Belgium.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Eli Lilly and Company, Kobe, Japan.'}]",Headache,['10.1111/head.13897']
2055,32634360,The Health Effects Of Expanding The Earned Income Tax Credit: Results From New York City.,"Antipoverty policies may hold promise as tools to improve health and reduce mortality rates among low-income Americans. We examined the health effects of the New York City Paycheck Plus randomized controlled trial. Paycheck Plus tests the impact of a potential fourfold increase in the Earned Income Tax Credit for low-income Americans without dependent children. Starting in 2015, Paycheck Plus offered 5,968 study participants a credit of up to $2,000 at tax time (treatment) or the standard credit of about $500 (control). Health-related quality of life and other outcomes for a representative subset of these participants ( n  = 3,289) were compared to those of a control group thirty-two months after randomization. The intervention had a modest positive effect on employment and earnings, particularly among women. It had no effect on health-related quality of life for the overall sample, but women realized significant improvements.",2020,"It had no effect on health-related quality of life for the overall sample, but women realized significant improvements.",['low-income Americans without dependent children'],[],"['mortality rates', 'health-related quality of life', 'Health-related quality of life']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",5968.0,0.122012,"It had no effect on health-related quality of life for the overall sample, but women realized significant improvements.","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Courtin', 'Affiliation': 'Emilie Courtin (Emilie.Courtin@lshtm.ac.uk) is an assistant professor in the Department of Public Health, Environments, and Society in the Faculty of Public Health and Policy at the London School of Hygiene and Tropical Medicine, in London, United Kingdom. At the time the study was conducted, she was a David E. Bell Fellow at the Harvard Center for Population and Development Studies, in Boston, Massachusetts.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Aloisi', 'Affiliation': ""Kali Aloisi is a master's degree student in the Department of Statistics, University of Michigan, in Ann Arbor. At the time the study was conducted, she was a research assistant at MDRC, in New York City.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Cynthia Miller is a senior fellow in the Low-Wage Workers and Communities Policy Area, MDRC.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Allen', 'Affiliation': 'Heidi L. Allen is an associate professor in the School of Social Work, Columbia University, in New York City.'}, {'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Katz', 'Affiliation': 'Lawrence F. Katz is the Elisabeth Allison Professor of Economics in the Department of Economics, Harvard University, in Cambridge, Massachusetts.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Muennig', 'Affiliation': 'Peter Muennig is a professor of health policy and management at the Mailman School of Public Health, Columbia University.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2019.01556']
2056,32634485,Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial.,"BACKGROUND


Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video.
METHODS


This is an ongoing, single-blind efficacy RCT. Recruitment began in November 2019 and will continue until March 2022. We will enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms. We will use a shared-baseline, linear mixed model to compare the effect of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We will also develop NF-specific minimal clinically important difference (MCID) for QoL variables, and conduct mediation and moderation analyses to understand mechanisms of improvement.
DISCUSSION


This study has important clinical and public health implications for the psychosocial functioning of adolescents with NF. It provides a model for efficient delivery of virtual psychosocial care for adolescents with rare diseases. Plans for dissemination and implementation of the RY-NF should efficacy be ascertained are also discussed.",2020,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","['adolescents with NF, Resilient Youth with NF (RY-NF', 'adolescents with neurofibromatosis', 'adolescents with NF', 'adolescents with rare diseases', '200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms']","['educational control group, Health Education for NF (HE-NF', 'Virtual mind-body treatment', 'mind-body intervention', 'RY-NF versus HE-NF']",['quality of life (QoL) and psychosocial outcomes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0666435,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Reichman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: mreichman@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, Bronx, NY 10458, United States of America. Electronic address: eriklin@fordham.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 560, Boston, MA 02114, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106078']
2057,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND


Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
METHODS


This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
DISCUSSION


AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079']
2058,32634551,Effects of resistance training on hepcidin levels and iron bioavailability in older individuals with end-stage renal disease: A randomized controlled trial.,"Anemia is an inherent complication of older individuals with end-stage renal disease (ESRD) that is associated with inflammation which in turn is an important factor in the activation of hepcidin that contributes to the decrease in serum iron. Athough resistance training (RT) seems to reduce inflammation in ESRD, its influence on hepcidin and iron availability in hemodialysis patients is unclear. Therefore, the aim of this study was to exemine the effects of RT in on inflammatory profile, hepcidin, and iron status in older individuals with ESRD. End-stage renal disease patients (N: 157, age: 66.8 ± 3.6; body mass: 73 ± 15 body mass index:27 ± 3), were assigned to control (CTL n: 76) and exercise groups (RT n: 81). RT consisted of 24 weeks/3 days per week of a moderate intensity. There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile. These novel findings show that RT is a potential coadjuvant to reduce iron deficiency by decreasing the levels of hepcidin and pro-inflammatory markers in older patients undergoing hemodialysis.",2020,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","['N: 157, age: 66.8\u202f±\u202f3.6; body mass: 73\u202f±\u202f15 body mass index:27\u202f±\u202f3', 'older individuals with ESRD', 'older individuals with end-stage renal disease', 'older individuals with end-stage renal disease (ESRD', 'older patients undergoing hemodialysis', 'hemodialysis patients', 'End-stage renal disease patients']","['Athough resistance training (RT', 'RT', 'resistance training']","['inflammatory profile, hepcidin, and iron status', 'hepcidin levels and iron bioavailability', 'hepcidin levels', 'bioavailability of iron']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",157.0,0.0490397,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","[{'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil. Electronic address: hugo.efucb@gmail.com.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Cláudio Avelino Rodrigues', 'Initials': 'CAR', 'LastName': 'Santos', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Luiz Sinésio Silva', 'Initials': 'LSS', 'LastName': 'Neto', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'University of Nevada, Las Vegas, Department of Kinesiology and Nutrition Sciences, Las Vegas, NV, USA.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'André Bonadias', 'Initials': 'AB', 'LastName': 'Gadelha', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil; Federal Institute of Education, Science and Technology Goiano, Goiás, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111017']
2059,32634565,OCT (optical coherence tomography) contribution assessment in the revascularisation of long femoro-popliteal occlusive lesions (TASC C and D): a randomised trial.,"BACKGROUND


Endovascular treatment has become the first-line revascularisation technique for femoropopliteal lesions. This technique lacks of reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-D angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides none 3D information on the quality of the revascularisation completed, what could explain some of the early and late failures of the technique.
AIM


Our objective is to evaluate if intra-operative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions.
METHOD


the ToCaf trial is a multicentric, prospective, randomised, controlled, single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomisation will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intra-operative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomisation will be stratified by centre. The protocol has been submitted and approved by a French ethic's committee under ref CPP2019-12-098. The study has been registered under the reference NCT04434586on the clinicaltrials.gouv's website.
RESULTS


The primary outcome of the study is the primary patency at 12 months. The number of patients that need to be treated is 166 (83 in each group) considering 5% of not workable data. Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months.
CONCLUSION


The aim of the present study is to evaluate the potential benefit for patients on the result of endovascular revascularisation of long occlusive femoro-popliteal lesion at 12-month when using intraoperative OCT control .",2020,"Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months.
","['patients with long de novo occlusive femoropopliteal lesions', 'patients with occlusive femoropopliteal lesions', 'patients on the result of endovascular revascularisation of long occlusive femoro-popliteal lesion at 12-month when using intraoperative OCT control ']","['standard angiogram alone', 'OCT (optical coherence tomography) contribution assessment', 'intra-operative OCT control in addition to standard angiogram and group 2 with standard angiogram alone', 'intra-operative optical coherence tomography (OCT) control']","[""Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness"", 'primary patency rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",,0.0699652,"Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dubosq', 'Affiliation': 'Vascular Surgery, Institut Cœur-Poumon, CHU Lille.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Goueffic', 'Affiliation': 'Vascular center, Groupe hospitalier Paris Saint Joseph, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 Metrics : évaluation des technologies de santé et des pratiques médicales, F-59000, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Denies', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 Metrics : évaluation des technologies de santé et des pratiques médicales, F-59000, Lille, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 Metrics : évaluation des technologies de santé et des pratiques médicales, F-59000, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Goyault', 'Affiliation': 'Department of vascular and oncological interventional Radiology, Institut Cardiovasculaire de Strasbourg (ICS), Clinique Rhena.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sobocinski', 'Affiliation': 'Vascular Surgery, Institut Cœur-Poumon, CHU Lille. Electronic address: jonathan.sobocinski@univ-lille.fr.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.06.061']
2060,32634571,Pharmacokinetic Investigation of Synthetic Cannabidiol Oral Formulations in Healthy Volunteers.,"Recent advances in the research of medicinal cannabis has placed the non-intoxicating cannabinoid cannabidiol (CBD) at the front of many investigations. The reasons behind this popularity is the compound's therapeutic properties, alongside a safe profile of administration lacking addictive properties such as euphoric state of mind and characterized with a wide dosing range. Oral administration of CBD is challenging due to poor solubility in the gastro-intestinal system and susceptibility to extensive first pass metabolism. As a result, the practice in clinic and investigational trials is to administer cannabinoids in edible oils or oil-based solutions. Nonetheless, reported pharmacokinetics of cannabinoids and CBD in particular are not uniform among research groups and are affected by the vehicle of administration. The purpose of the work presented here is to investigate oral absorption processes of synthetic CBD when given in different oral formulations in healthy volunteers. The study design was a three way, blind, cross-over single administration study of 12 healthy male volunteers. CBD was administered in powder form, dissolved in sesame oil and in self-nano-emulsifying drug delivery system (SNEDDS). Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form. Overall plasma exposure of CBD did not differ between sesame oil vehicle and the SNEDDS formulation. However, administration of CBD in pure oil resulted in two absorption behaviors of early and delayed absorption among subjects, as opposed to SNEDDS platform that resulted in a uniform early absorption profile. Results of this trial demonstrate the importance of solubilization process of lipophilic drugs such as CBD and demonstrated the ability of the nano formulation to achieve a reliable, predictable PK profile of the drug. These findings offer a standardized oral formulation for the delivery of cannabinoids and contribute data for the growing field of cannabinoid PK.",2020,"Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form.","['Healthy Volunteers', 'healthy volunteers', '12 healthy male volunteers']","['synthetic CBD', 'Synthetic Cannabidiol Oral Formulations', 'CBD']","['absorption behaviors of early and delayed absorption', 'Overall plasma exposure of CBD', 'Cmax and AUC of CBD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",12.0,0.0381526,"Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form.","[{'ForeName': 'Dvora', 'Initials': 'D', 'LastName': 'Izgelov', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O.Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Elyad', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Dinorah', 'Initials': 'D', 'LastName': 'Barasch', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O.Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Regev', 'Affiliation': 'PureForm Biosciences, Los Angeles California.'}, {'ForeName': 'Abraham J', 'Initials': 'AJ', 'LastName': 'Domb', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O.Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O.Box 12065, Jerusalem 91120, Israel. Electronic address: amnonh@ekmd.huji.ac.il.'}]",European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,['10.1016/j.ejpb.2020.06.021']
2061,32634624,Effects of Screening Compliance on Long-term Reductions in All-cause and Colorectal Cancer Mortality.,"BACKGROUND & AIMS


Randomized trials have shown that biennial fecal occult blood test (FOBT) screening reduces mortality from colorectal cancer (CRC), but not overall mortality. Differences in benefit for men vs women, and by age, are unknown. We sought to evaluate long-term reduction in all-cause and CRC-specific mortality in men and women who comply with offered screening, and in different age groups, using individual participant data from 2 large randomized trials of biennial FOBT screening, compared with an intention to treat analysis.
METHODS


We updated the CRC and all-cause mortality from the Danish CRC screening trial (n=61,933) through 30 years of follow up and pooled individual participant data with individual 30-year follow-up data from the Minnesota Colon Cancer Control trial (n=46,551). We compared the biennial screening groups to usual care (controls) in individuals 50-80 years old using Kaplan Meier estimates of relative risks and risk differences, adjusted for study differences in age, sex, and compliance.
RESULTS


Through 30 years of follow up, there were 33,478 (71.9%) and 33,479 (72.2%) total deaths and 1023 (2.2%) and 1146 (2.5%) CRC deaths in the biennial screening (n=46,553) and control groups (n=46,358), respectively. Among compliers, biennial FOBT screening significantly reduced CRC mortality by 16% (relative risk [RR], 0.84; 95% CI, 0.74-0.96) and all-cause mortality by 2% (RR, 0.98; 95% CI, 0.97-0.99). Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09). The largest reduction in CRC mortality was in compliant men 60-69 years old (RR, 0.59; 95% CI, 0.42-0.81) and women 70 years and older (RR, 0.53; 95% CI, 0.30-0.94).
CONCLUSIONS


Long-term CRC mortality outcomes of screening among compliers using biennial FOBT are sustained, with a statistically significant reduction in all-cause mortality. The reduction in CRC mortality is greater in men than women-the benefit in women lags that of men by about 10 years.",2020,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","['men and women who comply with offered screening, and in different age groups']","['biennial screening groups to usual care (controls', 'biennial FOBT screening']","['total deaths', 'CRC mortality', 'CRC deaths', 'cause mortality', 'Colorectal Cancer Mortality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",61933.0,0.195055,"Among compliers, the reduction in CRC mortality was larger for men (RR, 0.75; 95% CI, 0.62-0.90) than women (RR, 0.91; 95% CI, 0.75-1.09).","[{'ForeName': 'Aasma', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': ''}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kaalby', 'Affiliation': ''}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Baatrup', 'Affiliation': ''}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Kronborg', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Duval', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shyne', 'Affiliation': ''}, {'ForeName': 'Jack S', 'Initials': 'JS', 'LastName': 'Mandel', 'Affiliation': ''}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Church', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.019']
2062,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
2063,32634654,Effectiveness of mechanical debridement with and without adjunct antimicrobial photodynamic for treating peri-implant mucositis among prediabetic cigarette-smokers and non-smokers.,"AIM


The aim of the present study was to compare the effectiveness of mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT) for treating peri-implant mucositis among prediabetic cigarette-smokers and non-smokers.
METHODS


Prediabetic and non-diabetic smokers and non-smokers with peri-implant mucositis were included. Patients with peri-implant mucositis were divided into 4 groups as follows: Group-1: Prediabetic smokers with peri-implant mucositis; Group-2: Prediabetic non-smokers with peri-implant mucositis; Group-3: Systemically-healthy smokers with peri-implant mucositis; and Group-4: Systemically-healthy non-smokers with peri-implant mucositis. Hemoglobin A1c levels were measured in all groups prior to MD with adjunct aPDT. Peri-implant plaque index (PI), bleeding on probing (BOP) and probing depth (PD) were assessed at baseline and at 4- and 12-weeks of follow-up. Sample-size estimation was done and data normality was assessed. Group-comparisons were performed. and P < 0.01 was selected as an indicator of statistical significance.
RESULTS


Fifteen, 15, 15 and 15 individuals were included in groups 1, 2, 3 and 4, respectively. At baseline, peri-implant PI, BOP and PD were comparable in all groups. In prediabetic smokers and non-smokers, there was no significant difference in peri-implant PI, BOP and PD at 4- and 12-weeks' follow-up. Among non-diabetic smokers and non-smokes MD with adjunct PDT significant reduced PI (P < 0.01) and PD (P < 0.01) at 4- and 12-weeks' follow-up.
CONCLUSION


The outcomes of MD with adjunct aPDT for the treatment of peri-implant mucositis are compromised in smokers and non-smokers with prediabetes. In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.",2020,"In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.","['Prediabetic and non-diabetic smokers and non-smokers with peri-implant mucositis were included', 'Group-1: Prediabetic smokers with peri-implant mucositis; Group-2: Prediabetic non-smokers with peri-implant mucositis; Group-3: Systemically-healthy smokers with peri-implant mucositis; and Group-4: Systemically-healthy non-smokers with peri-implant mucositis', 'prediabetic cigarette-smokers and non-smokers', 'Patients with peri-implant mucositis']","['aPDT', 'MD with adjunct aPDT', 'mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT', 'mechanical debridement with and without adjunct antimicrobial photodynamic']","['Hemoglobin A1c levels', 'peri-implant mucositis', 'Peri-implant plaque index (PI), bleeding on probing (BOP) and probing depth (PD', 'peri-implant PI, BOP and PD']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.010401,"In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.","[{'ForeName': 'Ahmed Saleh Saeed', 'Initials': 'ASS', 'LastName': 'Al Hafez', 'Affiliation': 'Public Health Department, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: ahmed.s.alhafez@student.riyadh.edu.sa.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Ingle', 'Affiliation': 'Public Health Department, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Alathra Abdullah', 'Initials': 'AA', 'LastName': 'Alshayeb', 'Affiliation': 'Dental Center Albaha, Aljubail, Alhassa, Saudi Arabia.'}, {'ForeName': 'Hamed Mohammad', 'Initials': 'HM', 'LastName': 'Tashery', 'Affiliation': 'Qunfidhah Dental Center, AlQunfidhah, Saudi Arabia.'}, {'ForeName': 'Abdulrahman Abdullah Mohammad', 'Initials': 'AAM', 'LastName': 'Alqarni', 'Affiliation': 'Dammam Medical Complex, AlKhubar, Saudi Arabia.'}, {'ForeName': 'Salma Hamed', 'Initials': 'SH', 'LastName': 'Alshamrani', 'Affiliation': 'Dental Center Albaha, Aljadin, Ishbiliyah, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101912']
2064,32634656,"Modified photodynamic therapy to minimize pain in the treatment of condylomata acuminata: a prospective, randomized, self-controlled study.","BACKGROUND


Pain is a major concern associated with conventional photodynamic therapy (C-PDT).
OBJECTIVE


To evaluate the efficacy, pain and safety of modified photodynamic therapy(M-PDT) for the treatment of condylomata acuminata.
METHODS


A prospective, randomized, self-controlled study was conducted. Warts were randomized to the M-PDT or C-PDT side. 5-aminolevulinic acid (ALA; 20%) was incubated for 3 h before patients were exposed to LED red light (100 J/cm2 ) on the C-PDT side and for 30 minutes before being exposed to LED red light (300 J/cm2 ) on the M-PDT side. Treatment was administered with 1-week interval for three weeks. The clearance rates were determined at one week and the recurrence rates at 4, 8, and 12 weeks after treatment. The pain and other side effects were also investigated.
RESULTS


A total of 24 patients with condylomata acuminata were enrolled in this trial. Twenty patients completed the trial. The clearance rates were 98.17% in the M-PDT side and 98.20% in the C-PDT side(P > 0.05). The recurrence rates were 11.11% and 10.53% (P > 0.05). However, M-PDT was almost painless (mean score 0.3 ± 0.47, range 0∼1), which was significantly less than that on the C-PDT side (mean score 3.6 ± 0.94, range 0∼1) (P < 0.05). Local erythema, mild edema and erosion were observed on both sides.
CONCLUSION


The modified PDT is basically painless with similar efficacy to conventional PDT, which is a major breakthrough of pain management in PDT.",2020,The recurrence rates were 11.11% and 10.53% (P > 0.05).,"['24 patients with condylomata', 'Twenty patients completed the trial', 'condylomata acuminata']","['Modified photodynamic therapy', 'conventional photodynamic therapy (C-PDT', '5-aminolevulinic', 'modified photodynamic therapy(M-PDT']","['Local erythema, mild edema and erosion', 'clearance rates', 'efficacy, pain and safety', 'recurrence rates', 'pain and other side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302180', 'cui_str': 'Condyloma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",24.0,0.0370031,The recurrence rates were 11.11% and 10.53% (P > 0.05).,"[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: wangxiuli_1400023@tongji.edu.cn.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101915']
2065,32634673,Ulipristal acetate versus gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Long term results of a double-blind randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the effect of ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy on long term secondary outcomes of the MYOMEX-trial, regarding quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control. A cost-analysis was also performed. Short-term primary and secondary outcomes are reported elsewhere.
STUDY DESIGN


A double-blind, randomized, controlled, non-inferiority trial in nine hospitals in the Netherlands. Participants were randomized in a 1:1 ratio (block size of four, stratified per hospital) to either UPA or GnRHa pre-treatment. Additional placebo injections containing saline, respectively daily placebo tablets were given to both groups to ensure double-blinding. Surgery was performed within a month after the last tablet. Women were followed up until six months post-surgery.
RESULTS


A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017. Uterine volume at six weeks post-operative did not differ significantly between both pre-treatment groups with 170.1 cm 3  (106.8-243.5; N = 29) vs. 152.8 cm 3  (92.3-205.6; N = 23) for the UPA- and GnRHa-group respectively (p = 0.423). Hemoglobin levels six weeks post-operatively recovered back to baseline and were not significantly different between groups with 7.7 mmol/L for the UPA- vs. 8.1 mmol/L for the GnRHa-group (p = 0.157; mean difference -0.4 (CI -0.9, 0.2). Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups. Symptom severity scores also decreased significantly at 6 week post-operatively compared to baseline, but did not differ between the treatment groups. Fibroid characteristics at baseline (e.g. mean diameter of largest fibroid) appeared not to be a confounding factor. An exploratory cost analysis showed no significant differences in absenteeism costs, total healthcare and societal costs, after adjustment for confounding factors.
CONCLUSION


Pre-treatment prior to laparoscopic myomectomy with UPA compared to GnRHa has similar effects on bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life from baseline up to six months post-operative. Due to the small sample size, these findings should be interpreted with caution. Also, no firm conclusions on costs could be made.",2020,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","['prior to laparoscopic myomectomy (MYOMEX trial', 'A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017', 'nine hospitals in the Netherlands']","['UPA or GnRHa pre-treatment', 'Ulipristal acetate versus gonadotropin-releasing hormone agonists', 'ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy', 'placebo injections containing saline, respectively daily placebo tablets']","['Fibroid characteristics', 'Hemoglobin levels', 'Menstrual bleeding pattern, quality of life, effects on general and sexual health', 'absenteeism costs, total healthcare and societal costs', 'bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life', 'Symptom severity scores', 'Uterine volume', 'quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",55.0,0.659859,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'De Milliano', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Mei-An', 'Initials': 'MA', 'LastName': 'Middelkoop', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: m.middelkoop@amsterdamumc.nl.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kwee', 'Affiliation': 'OLVG, Department of Obstetrics and Gynecology, Jan Tooropstraat 164, Amsterdam, The Netherlands.'}, {'ForeName': 'Peggy M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Máxima Medisch Centrum, Department of Obstetrics and Gynecology, De Run 4600, Veldhoven, The Netherlands.'}, {'ForeName': 'Benedictus C', 'Initials': 'BC', 'LastName': 'Schoot', 'Affiliation': 'Catharina Ziekenhuis, Department of Obstetrics and Gynecology, Michelangelolaan 2, Eindhoven, The Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'Van Baal', 'Affiliation': 'Flevoziekenhuis, Department Obstetrics and Gynecology, Hospitaalweg 1, Almere, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: w.hehenkamp@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.035']
2066,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
2067,32634760,Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial.,"BACKGROUND


Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes.
METHODS


Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 < 20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR < 20%.
RESULTS


Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4-84.5) and 70.5% (66.5-74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2-94.1) and 85.1% (81.7-87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54-0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40-0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59-1.33]; unadjusted HR for OS 0.83 [95% CI 0.45-1.54]).
CONCLUSIONS


No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule.",2020,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","['2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer', 'Patients with node-positive early breast cancer', 'hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype']","['DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel', 'progesterone receptor (PgR', 'dose-dense adjuvant chemotherapy']","['overall survival (OS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",2003.0,0.206045,"We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively).","[{'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Carrer de Rosselló, 149, 08036, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bruzzone', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Breast Unit, Istituto Nazionale Tumori-Fondazione ""G. Pascale"", Via Mariano Semmola, 53, 80131, Naples, NA, Italy.'}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Valle', 'Affiliation': 'Department of Medical Oncology, Ospedale Businco, Via Edward Jenner, 1, 09121, Cagliari, CA, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Department of Clinical and Molecolar Medicine, La Sapienza University, Viale Regina Elena, 324, 00161, Rome, RM, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nisticò', 'Affiliation': 'Department of Medical Oncology 1, Istituto Nazionale Tumori ""Regina Elena"", Via Elio Chianesi, 53, 00128, Rome, RM, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Sergio Pansini, 5, 80131, Naples, NA, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Breast Unit, Department of Oncology, Azienda Ospedaliera Santa Croce e Carle, Via Michele Coppino, 26, 12100, Cuneo, CN, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gamucci', 'Affiliation': 'Department of Medical Oncology, Ospedale Sandro Pertini, Via dei Monti Tiburtini, 385/389, 00157, Rome, RM, Italy; Department of Medical Oncology, Ospedale SS Trinità, Località San Marciano, 03039, Sora, FR, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Strada Provinciale, 142, 10060, Turin, TO, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Department of Medicine, University of Udine, Piazzale Massimiliano Kolbe, 4, 33100, Udine, Italy; Department of Medical Oncology, IRCCS Centro di Riferimento Oncologico Aviano - National Cancer Institute, Via Franco Gallini, 2, 33081, Aviano, PN, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cardinali', 'Affiliation': 'Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostic (DISC), University of Genova, Viale Benedetto XV, 6, 1612, Genoa, GE, Italy; Department of Surgery, IRCCS Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Miglietta', 'Affiliation': 'Medical Oncology Unit 2, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Medical Oncology Department, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 1632, Genoa, GE, Italy; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ceppi', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Viale Benedetto XV, 10, 16132, Genoa, GE, Italy; Breast Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genoa, GE, Italy. Electronic address: lucia.delmastro@hsanmartino.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.007']
2068,32634774,A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer.,"BACKGROUND


Increasing demand for genetic testing for inherited cancer risk coupled with a shortage of providers trained in genetics highlight the potential for automated tools embedded in the clinic process to meet this demand. We developed and tested a scalable, easy-to-use, 12-minute web-based educational tool that included standard pretest genetic counseling elements related to panel-based testing for multiple genes associated with cancer risk.
METHODS


The tool was viewed by new patients at the Vanderbilt Hereditary Cancer Clinic before meeting with a board-certified genetics professional. Pre- and post-tool surveys measured knowledge, feeling informed/empowered to decide about testing, attitudinal values about genetic testing, and health literacy. Of the initial 100 participants, 50 were randomized to only have knowledge measured on the post-tool survey to assess for a priming effect.
RESULTS


Of 360 patients approached, 305 consented and completed both the pre- and post-tool surveys, with a mean age of 47 years, including 80% female patients and 48% patients with cancer. Survey results showed an increase in knowledge and feeling informed/empowered after viewing the tool (P<.001), but no significant change in attitude (P=.64). Post-tool survey data indicated no difference in median knowledge between low and high health literacy groups (P=.30). No priming effect was present among the initial 100 participants (P=.675).
CONCLUSIONS


Viewing the educational tool resulted in significant gains in knowledge across health literacy levels, and most individuals felt informed and empowered to decide about genetic testing. These findings indicate that the use of an automated pretest genetic counseling tool may help streamline the delivery of genetic services.",2020,"Survey results showed an increase in knowledge and feeling informed/empowered after viewing the tool (P<.001), but no significant change in attitude (P=.64).","['305 consented and completed both the pre- and post-tool surveys, with a mean age of 47 years, including 80% female patients and 48% patients with cancer', '360 patients', 'new patients at the Vanderbilt Hereditary Cancer Clinic before meeting with a board-certified genetics professional']",[],"['knowledge and feeling', 'median knowledge']","[{'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",360.0,0.0233029,"Survey results showed an increase in knowledge and feeling informed/empowered after viewing the tool (P<.001), but no significant change in attitude (P=.64).","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cragun', 'Affiliation': '1College of Public Health, University of South Florida, Tampa, Florida; and.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': '2Division of Genetic Medicine, Department of Medicine, Vanderbilt University Medical Center, and.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tezak', 'Affiliation': '2Division of Genetic Medicine, Department of Medicine, Vanderbilt University Medical Center, and.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zuniga', 'Affiliation': '2Division of Genetic Medicine, Department of Medicine, Vanderbilt University Medical Center, and.'}, {'ForeName': 'Georgia L', 'Initials': 'GL', 'LastName': 'Wiesner', 'Affiliation': '2Division of Genetic Medicine, Department of Medicine, Vanderbilt University Medical Center, and.'}, {'ForeName': 'Tuya', 'Initials': 'T', 'LastName': 'Pal', 'Affiliation': '2Division of Genetic Medicine, Department of Medicine, Vanderbilt University Medical Center, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7546']
2069,32634815,Comparison of Circulating Levels of Uremic Toxins in Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE) Randomized Control Study.,"INTRODUCTION


Removal of uremic toxins is a main objective of hemodialysis; however, whether high-flux and medium cut-off (MCO) membranes differ as regards removal of middle and large uremic toxins is not clear.
OBJECTIVE


To compare medium cut-off and high-flux dialyzers as regards their intra- and interdialysis effect on circulating levels of middle and large uremic toxins and serum albumin.
METHODS


Fifty-two patients were randomized to have hemodialysis with either 3 months of high-flux dialyzer followed by 3 months of MCO or vice versa. Blood samples were taken before and after dialysis at the first and last sessions of each dialyzer for analyses of middle and large uremic toxins including inflammatory mediators and vascular endothelial growth factor (VEGF), and serum albumin.
RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all). Last session predialysis levels of β-2 microglobulin, free kappa light chain, and free lambda light chain were lower than first session predialysis levels in MCO dialyzers as compared to high-flux dialyzers (p < 0.05 for all). Last session levels of interleukin-6, interleukin-10, interleukin-17, and interferon-gamma did not differ between dialyzers (p > 0.05 for all). VEGF level was lower in the MCO group compared to the high-flux group (p = 0.043). Last session level of serum albumin with MCO dialyzers was lower than that with high-flux dialyzers (3.62 [3.45-3.88] vs. 3.78 [3.58-4.02] g/L) (p = 0.04) and 6.7% lower (p < 0.001) than at the first session of MCO dialyzers.
CONCLUSION


The decline in circulating levels of several middle and large uremic toxins including VEGF following hemodialysis was more pronounced when using MCO membranes as compared to high-flux membranes while their effect on inflammatory molecules was similar.",2020,"RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all).","['Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE', 'Fifty-two patients']","['high-flux dialyzer followed by 3 months of MCO or vice versa', 'MCO', 'medium cut-off and high-flux dialyzers']","['inflammatory mediators and vascular endothelial growth factor (VEGF), and serum albumin', 'interleukin-6, interleukin-10, interleukin-17, and interferon-gamma', 'VEGF level', 'β-2 microglobulin, free kappa light chain, and free lambda light chain', 'Last session level of serum albumin with MCO dialyzers', 'postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443743', 'cui_str': 'Free kappa light chain'}, {'cui': 'C0443744', 'cui_str': 'Free lambda light chain'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0021037', 'cui_str': 'Immunoglobulin, L chain, lambda'}]",52.0,0.019657,"RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all).","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sevinc', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nuri Baris', 'Initials': 'NB', 'LastName': 'Hasbal', 'Affiliation': 'Nephrology Department, Hakkari State Hospital, Hakkari, Turkey.'}, {'ForeName': 'Vuslat', 'Initials': 'V', 'LastName': 'Yilmaz', 'Affiliation': 'Neuroscience Department, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Basturk', 'Affiliation': 'Nephrology Department, University of Health Sciences, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey, tanerbast@yahoo.com.'}, {'ForeName': 'Elbis', 'Initials': 'E', 'LastName': 'Ahbap', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Sakaci', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Perin Nazif', 'Initials': 'PN', 'LastName': 'Ozcafer', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Unsal', 'Affiliation': 'Nephrology Department, University of Health Sciences, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Blood purification,['10.1159/000508061']
2070,32634820,Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial.,"BACKGROUND


Clinicians could modify dietary interventions during early infancy by monitoring fat and fat-free mass accretion in very preterm infants.
METHODS


Preterm infants were randomly assigned to either having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group). All infants underwent serial assessments of body composition by air-displacement plethysmography before 32 weeks of postmenstrual age (PMA) and at 36 weeks PMA. The primary outcome was percent body fat (%BF) at 3 months of corrected age (CA).
RESULTS


Fifty infants were randomized (median gestational age: 30 weeks; mean ± SD birth weight: 1387 ± 283 g). The mean %BF increased from 7 ± 4 before 32 weeks PMA to 20 ± 5 at 3 months CA. The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4). Feeding practices and anthropometric measurements during hospitalization did not differ between groups.
CONCLUSIONS


Serial assessments of body composition in both intervention and control groups showed consistent increments in %BF. However, providing this information to clinicians did not influence nutritional practices or growth.
IMPACT


Serial assessments of body composition in preterm infants at 32 and 36 weeks postmenstrual age show consistent increments in % body fat up to 3 months of corrected age.However, providing this information to the clinician did not influence nutritional practices or growth.",2020,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"['very preterm infants', 'Fifty infants were randomized (median gestational age: 30 weeks; mean\u2009±\u2009SD birth weight: 1387\u2009±\u2009283\u2009g', 'Preterm infants', 'preterm infants at 32 and 36 weeks postmenstrual age']","['Serial assessment of fat and fat-free mass accretion', 'having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group']","['body composition', 'mean %BF', 'percent body fat (%BF']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",50.0,0.0677656,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA. asalas@peds.uab.edu.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}]",Pediatric research,['10.1038/s41390-020-1052-x']
2071,32634847,Hemostatic Adaptations to High Intensity Interval Training in Healthy Adult Men.,"Regular exercise is theorized to reduce cardiovascular risk by attenuating coagulation and augmenting fibrinolysis. However, these adaptations have not been consistently observed during traditional exercise programs. The purpose of this study was to examine hemostatic adaptations in healthy men following four (4W) and eight (8W) weeks of high intensity interval training. Twenty-one men (age=25±1 y; body mass index=26.5±6.4 kg/m 2 ) completed eight weeks, three days/week of high intensity interval training on a cycle ergometer. Activated partial thromboplastin time, prothrombin time, and plasma concentrations of thrombin-antithrombin III, fibrinogen, tissue plasminogen activator, and plasminogen activator inhibitor-1 were assessed at baseline (BL), 4W, and 8W. Repeated measures ANOVA were used to determine potential effects of training. There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05). Fibrinogen was significantly lower at 4W (238.6±70.3 mg/dL) compared to BL (285.0±82.1 mg/dL; p<0.05) and 8W (285.3±83.2 mg/dL; p<0.05). These findings indicate that eight weeks of high intensity interval training does not influence coagulation potential and/or stimulate fibrinolysis.",2020,"There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05).","['Twenty-one men (age=25±1\u2009y; body mass index=26.5±6.4\u2009kg/m 2 ', 'Healthy Adult Men', 'healthy men following four (4W) and eight (8W) weeks of high intensity interval training']","['High Intensity Interval Training', 'high intensity interval training on a cycle ergometer', 'Regular exercise']","['activated partial thromboplastin time', 'hemostatic adaptations', 'tissue plasminogen activator', 'plasminogen activator inhibitor-1', 'prothrombin time', 'Activated partial thromboplastin time, prothrombin time, and plasma concentrations of thrombin-antithrombin III, fibrinogen, tissue plasminogen activator, and plasminogen activator inhibitor-1', 'coagulation potential and/or stimulate fibrinolysis', 'thrombin-antithrombin III', 'Fibrinogen']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}]",21.0,0.0755851,"There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05).","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Sackett', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}, {'ForeName': 'Dan P', 'Initials': 'DP', 'LastName': 'Farrell', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Nagelkirk', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}]",International journal of sports medicine,['10.1055/a-1165-2040']
2072,32620131,Gait improvements by assisting hip movements with the robot in children with cerebral palsy: a pilot randomized controlled trial.,"BACKGROUND


Recently, rehabilitation robots are expected to improve the gait of cerebral palsy (CP) children. However, only few previous studies have reported the kinematic and kinetic changes by using wearable exoskeleton robots. The aim of this study was to investigate the change in gait parameters in CP children by training with the wearable robot-assisted gait training.
METHODS


10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial. Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT) were performed on the treadmill with the Honda Walking Assist (HWA) in two different days. To examine the carry-over effect from treadmill walking to overground walking, participants also performed 5.5 m overground-walks without the HWA before and after treadmill training (pre- and post-trial). During treadmill walking, peak of both hip and knee angles were measured. Also, we calculated the limb symmetry of hip range of motion. In addition, gait speed and ground reaction force were measured in overground trials.
RESULTS


The maximum hip angle on the limb with fewer hip movements, which was defined as the affected limb, showed a significant interaction between ASSIST (RAGT and NAGT) and TIME (pre- and post-trial) (p < 0.05). Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT. Furthermore, the affected limb showed a significant increase in the positive peak of the anterior-posterior ground reaction force during 70-100% of the gait cycle (p < 0.05). However, there was no change in gait speed.
CONCLUSION


By assisting the both hip movements with the HWA, maximum hip flexion and extension angle of the affected limb improved. Also, limb symmetry and propulsion force of the affected limb improved. Our results suggest that assisting both hip movements with the HWA might be an effective method for improving gait in CP children.
TRIAL REGISTRATION


UMIN-CTR, UMIN000030667. Registered 3 January 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033737.",2020,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","['10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial', 'CP children by training with the wearable robot-assisted gait training', 'children with cerebral palsy', 'cerebral palsy (CP) children']","['Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT', 'treadmill walking to overground walking, participants also performed 5.5\u2009m overground-walks without the HWA before and after treadmill training']","['Gait improvements', 'positive peak of the anterior-posterior ground reaction force', 'maximum hip angle on the limb with fewer hip movements', 'gait speed', 'limb symmetry of hip range of motion', 'gait speed and ground reaction force', 'Limb symmetry', 'gait parameters', 'limb symmetry and propulsion force']","[{'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0698618,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","[{'ForeName': 'Shihomi', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan. kawasaki.shihomi.55n@kyoto-u.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shigehito', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00712-3']
2073,32620144,The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to-negative conversion of COVID-19 nucleic acid test.
TRIAL DESIGN


This is a single centre, 2-arm (1:1 ratio), evaluator blinded, parallel group design superiority randomised, controlled clinical trial.
PARTICIPANTS


The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs. The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5) Those with shock (6) Those that have bleeding tendency or active bleeding in the lungs, (7) Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11) Those without signed informed consent and (12) Those with other contraindications to short wave. This study will be conducted in Tongji Hospital, Caidian, Wuhan, People's Republic of China.
INTERVENTION AND COMPARATOR


The experimental group will be given the nationally recommended standard medical treatment + ultra-short-wave diathermy treatment. Ultra-short-wave therapy treatment will be performed through application of ultra-short-wave therapy machine electrodes on the anterior and posterior parts of the trunk for 10 minutes, twice a day for 12 consecutive days. The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment.
MAIN OUTCOMES


The primary outcome measures will be time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab, in days assessed at 7 th , 14 th  ,21 st  and 28 th  days. The secondary outcome measures include nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores. Blinded evaluation will be at baseline (the day of starting ultra-short-wave diathermy) and after 28 days following the interventions.
RANDOMISATION


A Randomization plan will be generated online on www.randomization.com using permuted blocks method, by a statistician who will not be part of the study. Small blocks of various sizes will be used. Patients will be randomized (1:1) between the experimental and control groups BLINDING (MASKING): This will be an evaluator blinded study. Due to the nature of the intervention, blinding of patients and healthcare workers is not possible.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 410 patients will be randomised in 1:1 ratio to two groups: experimental group (n=205) and control group (n=205).
TRIAL STATUS


Protocol version 1 was approved on 02/12/2020. Recruitment for this trial began on 02/18/2020 and will be ongoing till the required sample size is reached. The analysis deadline is August 2020.
TRIAL REGISTRATION


This randomised controlled trial has been prospectively registered with the Chinese Clinical Trials ( ChiCTR2000029972 ) on 17 February 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."" The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment.
","['The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5', ""Tongji Hospital, Caidian, Wuhan, People's Republic of China"", '410 patients', 'The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs', '17 February 2020', 'Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11']","['standard medical treatment + ultra-short-wave diathermy treatment', 'shortwave diathermy', 'ultra-short-wave diathermy (SWD']","['COVID-19 pneumonia', 'time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab', 'bleeding tendency or active bleeding', 'nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores', 'treating Novel coronavirus (COVID-19) pneumonia']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0026934', 'cui_str': 'Genus Mycoplasma'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0085195', 'cui_str': 'Shadowing (Histology)'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204027', 'cui_str': 'Short wave diathermy'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",410.0,0.251351,"The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasb', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Zulfiqar Ali', 'Initials': 'ZA', 'LastName': 'Sayed Shah', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Liangjiang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China. chenhong1129@hust.edu.cn.""}]",Trials,['10.1186/s13063-020-04534-5']
2074,32621465,[Clinical and neurophysiological effects of dual-target high-frequency rTMS over the primary motor and prefrontal cortex in Parkinson's disease].,"OBJECTIVE


To evaluate therapeutic effects of navigational dual-target high-frequency rTMS over the primary motor (M1, bilateral) and the left dorsolateral prefrontal cortex (DLPFC) on clinical dynamics of Parkinson's disease (PD) symptoms in a parallel placebo-controlled study.
MATERIAL AND METHODS


The study included 46 patients randomized into equal therapeutic and placebo rTMS groups. Navigational therapeutic and placebo10 Hz rTMS was applied over the M1 and DLPFC areas (20 daily sessions, for 3 weeks). Assessment of the dynamics of clinical symptoms was performed using the MDS UPDRS scale (Parts I-IV) before the first session, immediately after 20 sessions, and 4-6 weeks after the rTMS course. Non-motor and mental symptoms were assessed using the Hamilton Depression Rating Scale (HDRS-17), Beck depression inventory (BDI-II), Depression, Anxiety and Stress (DASS-21) scales and the Mini Mental State Examination (MMSE).
RESULTS


Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV). The effects of rTMS on motor symptoms persisted 4 weeks after the end of the stimulation course. It is also important to note significant positive dynamics in both rTMS and placebo groups in the form of comparable reduction in the severity of everyday motor symptoms (MDS-UPDRS part II), improvement of the total scores on MMSE, HDRS, BDI-II, DASS-21.
CONCLUSIONS


The dual-target high-frequency rTMS over the primary motor cortex (bilateral) and the left dorsolateral prefrontal cortex has positive therapeutic effects on the motor and affective symptoms of Parkinson's disease, which are significantly stronger than that of the placebo stimulation.",2020,"RESULTS


Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV).","[""Parkinson's disease"", '46 patients randomized into']","['equal therapeutic and placebo rTMS', 'Navigational therapeutic and placebo10', 'rTMS', 'navigational dual-target high-frequency rTMS', 'dual-target high-frequency rTMS', 'Hz rTMS', 'placebo']","['motor and mental symptoms', 'symptoms of rigidity, bradykinesia and postural instability', 'MDS UPDRS scale', 'motor symptoms', 'Hamilton Depression Rating Scale (HDRS-17), Beck depression inventory (BDI-II), Depression, Anxiety and Stress (DASS-21) scales and the Mini Mental State Examination (MMSE', 'severity of non-motor (part I) and motor symptoms', 'overall score on the MDS-UPDRS scale', 'total scores on MMSE, HDRS, BDI-II, DASS-21']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",46.0,0.0392555,"RESULTS


Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV).","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Aftanas', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Brack', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Kulikova', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Filimonova', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Dzemidovich', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Piradov', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Suponeva', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Poidasheva', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012005129']
2075,32621696,Patients use more topical medication when the medications come in a larger container.,"INTRODUCTION


Research shows that individuals consume more calories when provided with a larger portion size. It is unclear if similar behavior translates to topical medication use. The impact of container size and provider instructions on patient usage of topical medications has yet to be assessed.
METHODS


Data was collected from 128 participants in an IRB randomized, controlled trial. To a marked 3cmx8cm rectangle on the forearm, patients applied petroleum jelly from either a large container or a small tube. Pre and post application container weights were measured.
RESULTS


Patients applied more topical medication from the large container compared to the small tube.
CONCLUSION


Topical medication usage is influenced by the size of the container provided. It is beneficial to consider container size when prescribing topical medications and greater application is desired.",2020,"RESULTS


Patients applied more topical medication from the large container compared to the small tube.
","['Data was collected from 128 participants in an IRB randomized, controlled trial']",[],[],"[{'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],128.0,0.0273214,"RESULTS


Patients applied more topical medication from the large container compared to the small tube.
","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aung-Din', 'Affiliation': ''}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Seger', 'Affiliation': ''}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Unrue', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Devine', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': ''}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC Department of Social Sciences &amp; Health Policy, Wake Forest School of Medicine, Winston-Salem, NC Department of Dermatology, University of Southern Denmark, Odense. sfeldman@wakehealth.edu.'}]",Dermatology online journal,[]
2076,32621729,A mixed-method randomized feasibility trial evaluating progressive muscle relaxation or autogenic training on depressive symptoms and quality of life in people living with human immunodeficiency virus (HIV) who have depressive symptoms.,"Background Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life. Methods This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or a control group (CG), with four assessments (baseline, and at one, three, and six months). The PMR and AT interventions consisted of six 1 h sessions of individual training over 12 weeks, plus home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews. Results Following the screening, 54/63 people met the inclusion criteria, and 42/54 were randomly allocated to the PMR group (n=14), AT group (n=14), and CG (n=14). Six participants (43%; 95% CI 18-71%) in the PMR group and 10 (71%; 95% CI 42-92%) in the AT group completed the intervention. Participants reported better emotion management and improvements in depressive symptoms and quality of life. Conclusions The pilot study suggests that a randomized trial to test the effectiveness of these interventions is feasible. Trial registration ClinicalTrials.gov NCT01901016.",2020,Participants reported better emotion management and improvements in depressive symptoms and quality of life.,"['54/63 people met the inclusion criteria, and 42/54', 'people living with HIV and depressive symptoms', 'people living with human immunodeficiency virus (HIV) who have depressive symptoms', 'people living with HIV who have depressive symptoms']","['PMR', 'PMR and AT interventions', 'progressive muscle relaxation or autogenic training', ' Progressive muscle relaxation (PMR) and autogenic training (AT']","['depressive symptoms and quality of life', 'Depressive symptoms and quality of life', 'Recruitment, attrition, and completion rates', 'emotion management']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0004361', 'cui_str': 'Autogenic therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",,0.177044,Participants reported better emotion management and improvements in depressive symptoms and quality of life.,"[{'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Ramirez-Garcia', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Leclerc-Loiselle', 'Affiliation': 'Faculté des sciences infirmières, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Gagnon', 'Affiliation': ""Faculté des Sciences Infirmières de l'Université Laval, Quebec, Canada.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculté des sciences infirmières, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Brouillette', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Réjean', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': ""Clinique médicale l'Actuel, Montréal, Quebec, Canada.""}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0167']
2077,32621735,Expert advice about therapeutic exercise during pregnancy reduces the symptoms of sacroiliac dysfunction.,"Objectives There are growing evidence that exercise improves sacroiliac dysfunction symptoms in pregnant women; but no data about the effect of expert advice regarding this matter. The aim of this study was to assess the effectiveness of expert advice about therapeutic exercise on sacroiliac dysfunction in pregnancy. Methods A total of 500 women with sacroiliac dysfunction diagnosed in pregnancy were randomized in study and control group. Study group has conducted expert advice on therapeutic exercise; while control group continued with their normal lifestyle. Pain intensity by Visual Analog Scale (VAS) and degree of functional disability by Quebec scale were assessed at enrolment and after 3 and 6 weeks. Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group. Better results for both outcome measures were obtained if intervention was implemented earlier i.e., in second (p=0.001; p=0.001) compared to third (p=0.005; p=0.001) trimester. Strong positive correlation was found between pain intensity and degree of functional disability in both groups. Conclusions Expert advice on therapeutic exercise is effective in reduction of sacroiliac dysfunction symptoms during pregnancy. Trial registration ACTRN12617000556347.",2020,Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group.,"['sacroiliac dysfunction in pregnancy', '500 women with sacroiliac dysfunction diagnosed in pregnancy', 'pregnant women']","['expert advice about therapeutic exercise', 'exercise']","['degree of functional disability assessed by Quebec scale', 'Pain intensity by Visual Analog Scale (VAS) and degree of functional disability by Quebec scale', 'sacroiliac dysfunction symptoms', 'pain intensity assessed by VAS', 'pain intensity and degree of functional disability']","[{'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",500.0,0.118531,Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Filipec', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clinical hospital ""Sveti Duh"", Zagreb, Croatia.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Matijević', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Zagreb, Zagreb, Croatia.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0143']
2078,32621736,Effect of Oral Glucose Water Administration 1 Hour Preoperatively in Children with Cyanotic Congenital Heart Disease: A Randomized Controlled Trial.,"BACKGROUND Guidelines recommend a clear liquid fasting time of 2 h before surgery, which is often exceeded, leading to adverse reactions (ARs) such as discomfort, thirst, and dehydration. We assessed the gastric contents and ARs after oral glucose water administration 1 h prior to surgery in children with cyanotic congenital heart disease (CCHD). MATERIAL AND METHODS This was a non-inferiority randomized controlled trial of children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive oral glucose water (10 g of glucose in 100 ml of warm water, 5 ml/kg) 2 h (2-h group, n=174) or 1 h (1-h group, n=170) before surgery. The primary endpoint was gastric volume. Secondary endpoints included pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia. Pre- and intraoperative ARs were recorded. RESULTS The 1-h group showed smaller gastric content volumes (0.34±0.35 (95% CI: 0.29-0.39) vs. 0.43±0.33 (95% CI: 0.38-0.48) ml/kg, t=2.55, P<0.05) and higher blood glucose (6.21±0.78 (95% CI: 6.09-6.33) vs. 5.59±1.11 (95% CI: 5.43-5.76) mmol/L, t=-5.91, P<0.001). The 95% confidence interval of the volume difference between the 2 groups was 0.017-0.163, the upper limit value was 0.163 <delta=0.2 (P<0.01). The non-inferiority hypothesis was correct. The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group). There were no differences in ARs between the 2 groups. CONCLUSIONS A 1-h fast prior to surgery was not inferior to a 2-h fast in terms of gastric residuals and ARs in pediatric patients with CCHD.",2020,"The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group).","['Children with Cyanotic Congenital Heart Disease', 'children with cyanotic congenital heart disease (CCHD', 'children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive', 'pediatric patients with CCHD']","['oral glucose water (10 g of glucose', 'oral glucose water administration 1 h prior to surgery', 'Oral Glucose Water']","['Pre- and intraoperative ARs', 'higher blood glucose', 'gastric volume', 'lower incidence of crying, thirst and hypoxia', 'pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia', 'gastric contents and ARs', 'smaller gastric content volumes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0265808', 'cui_str': 'Cyanotic congenital heart disease'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.289219,"The 1-h group showed lower incidence of crying, thirst and hypoxia (all P<0.05 vs. 2-h group).","[{'ForeName': 'Xizhen', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Haoruo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fujian Medical University Union Clinical Medicine College, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Yanjuan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Liangwan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Sailan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Heart Medicine Research Center, Fujian Medical University Union Hospital, Fuzhou, Fujian, China (mainland).'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Fujian Medical University, Fuzhou, Fujian, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922642']
2079,32622171,Change in core symptoms of borderline personality disorder by tDCS: A pilot study.,"Borderline personality disorder (BPD) recognizes several psychopathological dimensions related to prefrontal cortex impairments. Transcranial Direct Current Stimulation (tDCS) targeting the right prefrontal dorsolateral cortex (DLPFC) positively influence cognitive functions related to impulsivity in healthy subjects. A randomized double-blind study was designed to investigate whether tDCS could modulate core dimensions (impulsivity, aggression, affective dysregulation) of BPD. Also effects on decision making process and substances craving was assessed. Patients were randomized to receive active-tDCS at 2 mA versus sham-tDCS, once a day for 15 sessions. Anode was placed on the right DLPFC (F4), cathode on the left DLPFC (F3). Impulsivity and aggression measures were significantly reduced only in patients treated with active-tDCS. Decision-making process was marginally influenced by the active current. Craving intensity was reduced only in the active-tDCS sample. Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms. The application of bilateral tDCS targeting right DLPFC with anodal stimulation seems to improve core dimensions of BPD (mainly impulsivity and aggression) probably by restoring prefrontal activity. tDCS might be a potential tool for preventing self-harming behaviors.",2020,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,['healthy subjects'],"['Transcranial Direct Current Stimulation (tDCS', 'active-tDCS at 2\xa0mA versus sham-tDCS', 'tDCS']","['Craving intensity', 'Impulsivity and aggression measures', 'decision making process and substances craving', 'affective dysregulation dimension and anxious and depressive symptoms', 'core dimensions (impulsivity, aggression, affective dysregulation) of BPD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]",,0.0377358,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,"[{'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Lisoni', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: jacopo.lisoni@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Miotto', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: miottopaola@yahoo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barlati', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.barlati@unibs.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.calza@unibs.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Crescini', 'Affiliation': 'Department of Mental Health, ASST Valcamonica, Esine, Italy. Via Manzoni 142, Esine, Brescia ITALY.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Deste', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: giacomodeste@mac.com.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: emilio.sacchetti@unibs.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vita', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: antonio.vita@unibs.it.'}]",Psychiatry research,['10.1016/j.psychres.2020.113261']
2080,32626876,[Evaluation of the effects of TF and S3 nickel-titanium instruments in severely curved molar root canal preparation].,"PURSPOSE


To compare the shaping ability and dental cracks of Twisted File and S3 in severely curved molar root canal preparation.
METHODS


Sixty extracted mandibular molars with mesiobuccal canals (canal curvature angles beyond 25°) were selected and divided randomly into 2 groups with 30 canals in each group. The canals were scanned by cone-beam CT(CBCT) before and after root canal preparation .The canal transportation was recorded at 3 points (3, 5, 7 mm to root tip). After root canal preparation，all the roots were horizontally sectioned 3，5 and 7mm from the apex. The slices were observed under optical stereomicroscope. SPSS 19.0 software package was used for statistical analysis.
RESULTS


Transportations occurred in all groups. No significant difference was found between the two groups of canal transportation at the two points (5 mm and 7 mm to root tip) (P>0.05); at the point of 3 mm to the root tip,the transportation of canals prepared by S3 was obviously lesser than the canals prepared by TF. There was no significant difference in the incidence of dentinal cracks between the two groups (P>0.05).
CONCLUSIONS


Under the conditions of severely curved molar root canal in extracted teeth, cracks were found in both groups, S3 was found to be better in maintaining original canal shape than TF system.",2020,"There was no significant difference in the incidence of dentinal cracks between the two groups (P>0.05).
","['severely curved molar root canal preparation', 'Sixty extracted mandibular molars with mesiobuccal canals (canal curvature angles beyond 25°']",['TF and S3 nickel-titanium instruments'],"['incidence of dentinal cracks', 'canal transportation']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}]",60.0,0.0222399,"There was no significant difference in the incidence of dentinal cracks between the two groups (P>0.05).
","[{'ForeName': 'Er-Mei', 'Initials': 'EM', 'LastName': 'Feng', 'Affiliation': 'Department of Stomatology, Stomatology Hospital of Southern Medical University, Guangdong Stomatology Hospital. Guangzhou 510280, Guangdong Province, China. E-mail:midang868@163.com.'}, {'ForeName': 'Jian-Zhen', 'Initials': 'JZ', 'LastName': 'Yang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2081,32626888,[Evaluation of 93 cases of mandibular first molar root bifurcation lesions treated with autologous dentin Granules combined with platelet-rich fibrin membrane].,"PURPOSE


To investigate the efficacy of autologous dentin particles combined with platelet-rich fibrin membrane (PRF) in the treatment of root bifurcation lesions of mandibular first molar.
METHODS


Ninety-three patients (93 teeth) with mandibular first molar root bifurcation lesions were selected from our department from February 2016 to October 2017. They were randomly divided into 2 groups. Forty-six patients with 46 teeth in the experimental group underwent autologous dentin particles combined with platelet-rich fibrin membrane, while patents in the control group (47 patients with 47 teeth) were treated with Bio-Oss implanted in the bone defect area covered with collagen membrane. The patients were revisted at 1, 3, 6 and 12 months after operation. The success rate of the operation group, the depth of periodontal pocket (PD), the loss of attachment (AL), the depth of penetration of the root bifurcation (HPD), and the bone density of the root bifurcation area before and after treatment. The data were recorded and compared with SPSS25.0 software package.
RESULTS


The success rate was 97.83%(45/46) in the experimental group, 85.11%(40/47) in the control group, the difference between the two groups was significant(P<0.05). After treatment, PD, AL and HPD decreased significantly (P<0.05), and MGVs increased gradually. There was no significant difference in MGVs before treatment and 1 month after treatment in the experimental group (P>0.05). MGVs at other time points were significantly higher than those of the control group (P<0.05). PD, AL and HPD of the experimental group were lower significantly than the control group at each time point after treatment (P<0.05), and MGVs value was significantly higher than the control group (P<0.05). There was no significant difference in the incidence of complications(4.35% vs 6.38%, χ 2 =0.189, P>0.05).
CONCLUSIONS


Autologous dentin particles combined with platelet-rich fibrin membrane is effective for the treatment of root bifurcation lesions of mandibular first molar, which is worthy of wide application.",2020,"PD, AL and HPD of the experimental group were lower significantly than the control group at each time point after treatment (P<0.05), and MGVs value was significantly higher than the control group (P<0.05).","['root bifurcation lesions of mandibular first molar', 'Forty-six patients with 46 teeth in the experimental group underwent', '93 cases of mandibular first molar root bifurcation lesions treated with', 'Ninety-three patients (93 teeth) with mandibular first molar root bifurcation lesions were selected from our department from February 2016 to October 2017']","['autologous dentin particles combined with platelet-rich fibrin membrane', 'Bio-Oss implanted in the bone defect area covered with collagen membrane', 'autologous dentin particles combined with platelet-rich fibrin membrane (PRF', 'autologous dentin Granules combined with platelet-rich fibrin membrane']","['MGVs', 'depth of periodontal pocket (PD), the loss of attachment (AL), the depth of penetration of the root bifurcation (HPD), and the bone density of the root bifurcation area', 'PD, AL and HPD', 'MGVs value', 'success rate']","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0564382', 'cui_str': 'Depth of periodontal pocket'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0121300', 'cui_str': 'Hematoporphyrin D'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.0175947,"PD, AL and HPD of the experimental group were lower significantly than the control group at each time point after treatment (P<0.05), and MGVs value was significantly higher than the control group (P<0.05).","[{'ForeName': 'Zheng-Rong', 'Initials': 'ZR', 'LastName': 'Wu', 'Affiliation': 'Department of Stomatology, Maternal and Child Health Care Hospital of Huadu District. Guangzhou 510800, Guangdong Province, China. E-mail:oppa744@126.com.'}, {'ForeName': 'Yuan-Lin', 'Initials': 'YL', 'LastName': 'Zuo', 'Affiliation': ''}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2082,32626889,[Effect of oral implant restoration on dentition defect patients and its impact on TNF-α and IL-6 levels in gingival crevicular fluid].,"PURPOSE


To investigate the clinical effects of oral implant restoration in patients with dentition defects and the its impact on tumor necrosis factor-α(TNF-α) and interleukin-6(IL-6) levels in gingival crevicular fluid.
METHODS


Eighty-four patients with dentition defects from May 2017 to August 1919 in People's Hospital of Shanghai Pudong District were enrolled and randomly divided into control group (n=42) and experimental group (n=42). Patients in the control group were repaired by routine methods,while those in the experimental group were treated with oral implant restoration. The effect of restoration was evaluated 6 months after treatment. The levels of TNF-α, IL-6 in the gingival crevicular fluid and dental function were compared between the 2 groups. The data were analyzed using SPSS 18.0 software package.
RESULTS


The levels of TNF-α and IL-6 in the experimental group and the control group after treatment were significantly higher than those before treatment (P<0.05). The levels of TNF-α and IL-6 in the experimental group were significantly lower than those in the control group 6 months after treatment (P<0.05). The scores of dental function in the experimental group and the control group were significantly higher than those before treatment (P<0.05). The scores of retention, speech, chewing and aesthetics of the experimental group 6 months after treatment were significantly higher than the control group (P<0.05). The incidence of infection, pricking, post and core loosing and teeth missing in the experimental group was significantly lower than that of the control group (P<0.05).
CONCLUSIONS


In the treatment of patients with dentition defects, implant restoration has little effect on the levels of TNF-α and IL-6 in gingival crevicular fluid, which is helpful to improve dental function and reduce the incidence of postoperative complications. Therefore, it is worthwhile to be popularized in clinical application.",2020,The levels of TNF-α and IL-6 in the experimental group were significantly lower than those in the control group 6 months after treatment (P<0.05).,"['gingival crevicular fluid', 'dentition defect patients', 'patients with dentition defects', ""Eighty-four patients with dentition defects from May 2017 to August 1919 in People's Hospital of Shanghai Pudong District were enrolled and randomly divided into control group (n=42) and experimental group (n=42""]",['oral implant restoration'],"['TNF-α and IL-6 levels', 'levels of TNF-α, IL-6 in the gingival crevicular fluid and dental function', 'levels of TNF-α and IL-6', 'scores of retention, speech, chewing and aesthetics', 'incidence of infection, pricking, post and core loosing and teeth missing', 'scores of dental function']","[{'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0011443', 'cui_str': 'Dentition'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0441366', 'cui_str': 'Jaw implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}]",84.0,0.0240856,The levels of TNF-α and IL-6 in the experimental group were significantly lower than those in the control group 6 months after treatment (P<0.05).,"[{'ForeName': 'Zhong-Fu', 'Initials': 'ZF', 'LastName': 'Chang', 'Affiliation': ""Department of Stomatology, 2.Blood Purification Center, People's Hospital of Shanghai Pudong District. Shanghai 201299, China. E-mail:czf315@126.com.""}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Zhi-Rong', 'Initials': 'ZR', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Cai', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
2083,32627052,The influence of different concentrations of flavanol chocolate bars under acute supplement conditions on exercise and performance.,"OBJECTIVE


The purpose of this study was to assess the effects and acute dosage of different flavanol concentrations in a dark chocolate bar on physiological parameters during steady state (SS) and incremental exercise.
METHODS


In a double-blind, randomised, crossover study, 15 healthy participants with a mean ± SD age of 30 ± 7 years; stature 176.8 ± 8.6 cm and body mass 80.3 ± 8.4 kg supplemented with high flavanol (HF) (1060 mg), moderate flavanol (MF) (746 mg), low flavanol (LF) (406 mg), or a control (CON) (88 mg) chocolate bar (~ 34 g), 2 h prior to 40 min of SS cycling (80% gas-exchange threshold) followed by an incremental test to volitional fatigue. During the SS cycle oxygen consumption ([Formula: see text]), respiratory exchange ratio (RER) and heart rate (HR) were continuously monitored. Plasma samples were collected prior to commencing exercise to determine nitrate (NO 3 - ) and nitrite (NO 2 - ) levels under each condition.
RESULTS


There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05). [Formula: see text], peak power, HR peak, and RER peak also did not significantly differ between conditions (P > 0.05). There was a small trend for higher plasma NO 2 -  levels following higher flavanol concentration; however, this did not reach statistical significance (P > 0.05).
CONCLUSION


Acute supplementation with cocoa of differing flavanol concentrations does not appear to have any effect on exercise and performance. It is plausible that longer flavanol supplementation periods might have greater accumulative effects and thus may potentially elicit a larger effect.",2020,"There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05).",['15 healthy participants with a mean\u2009±\u2009SD age of 30\u2009±\u20097\xa0years; stature 176.8\u2009±\u20098.6\xa0cm and body mass 80.3\u2009±\u20098.4\xa0kg supplemented with'],"['high flavanol (HF', 'moderate flavanol (MF) (746\xa0mg), low flavanol (LF) (406\xa0mg), or a control (CON) (88\xa0mg) chocolate bar (~\u200934\xa0g), 2\xa0h prior to 40\xa0min of SS cycling (80% gas-exchange threshold) followed by an incremental test to volitional fatigue', 'flavanol chocolate']","['peak power, HR peak, and RER peak', 'respiratory exchange ratio (RER) and heart rate (HR', 'flavanol concentrations on [Formula: see text], RER, and HR during SS cycling']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",15.0,0.127664,"There was no observed effect between flavanol concentrations on [Formula: see text], RER, and HR during SS cycling (P > 0.05).","[{'ForeName': 'Rishikesh K', 'Initials': 'RK', 'LastName': 'Patel', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, London, UK. Rishi.patel@stmarys.ac.uk.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brouner', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Allgrove', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Spendiff', 'Affiliation': 'School of Life Sciences, Kingston University, London, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04389-3']
2084,32627231,A multicomponent integrative intervention to slow down the progression of mild cognitive impairment: A protocol for a randomized controlled trial.,"Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years. Early intervention can slow down disease progression and thus delay dementia onset. The purpose of this article is to outline the protocol of an ongoing randomized controlled trial in mainland China that will evaluate the effects and feasibility of a 6-month multicomponent integrative intervention on the speed of progression of mild cognitive impairment to dementia. Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province. Participants will be allocated to receive either the multicomponent integrative intervention or usual care. The core components of the intervention are cognitive training, dietary instruction, physical activity, and management of vascular risk factors. Data are collected at the beginning of the study, then at 1, 3, and 6 months. The primary outcome is cognitive function. The main secondary outcomes are exercise capacity, comprehensive physical capacity, depression, and quality of life. An intention-to-treat analysis will be conducted. The study will be completed in 2021. The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.",2020,"The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.","['Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province', 'mild cognitive impairment', 'mild cognitive impairment to dementia', 'Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years']","['multicomponent integrative intervention', 'multicomponent integrative intervention or usual care']","['cognitive function', 'exercise capacity, comprehensive physical capacity, depression, and quality of life']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009472', 'cui_str': 'Community health services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.149996,"The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.","[{'ForeName': 'Qiyuan', 'Initials': 'Q', 'LastName': 'Lyu', 'Affiliation': 'School of Nursing, Jinan University, Guangzhou, China.'}, {'ForeName': 'Daphne S K', 'Initials': 'DSK', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Guangzhou, China.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Lai', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Yuanqiu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Nursing, People's Street Community Health Service Center, Guangzhou, China.""}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Research Institute of Gynecology and Obstetrics, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",Research in nursing & health,['10.1002/nur.22050']
2085,32627264,Impact of Left Common Pulmonary Veins in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) Study.,"BACKGROUND


Concerns remain regarding the effectiveness of PVI using the fixed diameter non-compliant cryoballoon in the presence of a left common pulmonary vein (LCPV). We sought to evaluate the effectiveness of PVI performed by contact-force guided radiofrequency (CF-RF) versus second-generation cryoballoon-based ablation in patients with LCPV.
METHODS AND RESULTS


We enrolled 346 patients with paroxysmal AF and randomized them to CF-RF or cryoballoon ablation. PV anatomy was not assessed prior to enrolment, and there were no exclusions based on PV anatomy. All patients received an implantable cardiac monitor. LCPV was observed in 13.6% of patients (47/346). Left atrial time and fluoroscopy time did not differ between those with and without LCPV (P=0.58 and P=0.06, respectively). Freedom from any atrial tachyarrhythmia at one year was observed in 46.8% with LCPV and 54.5% without LCPV (P=0.06). In those with LCPV the freedom from any atrial tachyarrhythmia did not differ between those randomized to CF-RF or cryoballoon ablation (HR for recurrence 1.19, 95% CI 0.53-2.65, P=0.69). In those with LCPV the AF burden was reduced to a similar extent with CF-RF and cryoballoon ablation (99.7% vs. 99.5%, respectively; P=0.97).
CONCLUSIONS


In this randomized clinical trial, the presence of a LCPV was associated with a trend towards higher rates of arrhythmia recurrence following PVI. No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE], NCT01913522) This article is protected by copyright. All rights reserved.",2020,"No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population.","['patients with LCPV', '346 patients with paroxysmal AF and randomized them to']","['Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE', 'CF-RF or cryoballoon ablation', 'PVI performed by contact-force guided radiofrequency (CF-RF) versus second-generation cryoballoon-based ablation', 'implantable cardiac monitor', 'LCPV']","['Left atrial time and fluoroscopy time', 'atrial tachyarrhythmia', 'AF burden', 'LCPV', 'arrhythmia recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231082', 'cui_str': 'Structure of common pulmonary vein'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0231082', 'cui_str': 'Structure of common pulmonary vein'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231082', 'cui_str': 'Structure of common pulmonary vein'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",346.0,0.113404,"No significant difference in arrhythmia recurrence was observed between patients with LCPV randomized to cryoballoon ablation or contact-force guided RF ablation, suggesting that either ablation modality is suitable in this population.","[{'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Sarrazin', 'Affiliation': 'Université Laval, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14652']
2086,32627271,The impact of the Glucagon-Like Peptide-1 Receptor Agonist Liraglutide on Natriuretic Peptides in Heart Failure Patients with Reduced Ejection Fraction with and without Type 2 Diabetes.,"BACKGROUND


The Glucagon-like peptide-1 receptor agonist liraglutide improves prognosis in patients with type 2 diabetes (T2D). However, the clinical usefulness in heart failure patients with reduced ejection fraction (HFrEF) remains uncertain. The efficacy of liraglutide in HFrEF with and without T2D can be assessed by changes in the prognostic markers of neurohormonal activation; midregional-pro-atrial-natriuretic-peptide (MR-proANP) and N-terminal brain-natriuretic-peptide (NT-proBNP).
METHODS


In the LIVE study, patients (n=241) with LVEF≤45% were randomized to liraglutide 1.8 mg daily or placebo for 24 weeks, and 30% had a concomitant diagnosis of T2D. Plasma levels of NT-proBNP (predefined secondary endpoint), MR-proANP, midregional-pro-adrenomedullin (MR-proADM) and copeptin were measured at baseline and after 24 weeks in this sub-study. The potential effect modification of T2D was assessed.
RESULTS


In the eligible subgroup of 231 patients with available biomarkers (115 randomized to liraglutide and 116 to placebo), MR-proANP decreased by 12% (P=0.002) and NT-proBNP by 9% (P=0.009) during liraglutide treatment compared to placebo at week 24. Interaction with T2D for the treatment effect of change in MR-proANP and NT-proBNP levels were P=0.003 and P=0.03, respectively. Consequently, in patients with T2D, liraglutide decreased MR-proANP by 27% (P<0.001) and NT-proBNP by 25% (P=0.02) as compared with placebo, whereas no change was observed in patients without T2D. There was no effect of liraglutide on MR-proADM (P=0.10) or copeptin (P=0.52).
CONCLUSION


Liraglutide decreased the A- and B-type natriuretic peptides significantly in patients with HFrEF and concomitant T2D, suggesting a beneficial mechanism of liraglutide in T2D patients with HFrEF. This article is protected by copyright. All rights reserved.",2020,"There was no effect of liraglutide on MR-proADM (P=0.10) or copeptin (P=0.52).
","['T2D patients with HFrEF', 'patients with type 2 diabetes (T2D', 'Heart Failure Patients with Reduced Ejection Fraction with and without Type 2 Diabetes', 'patients (n=241) with LVEF≤45', 'heart failure patients with reduced ejection fraction (HFrEF', '231 patients with available biomarkers (115 randomized to']","['liraglutide 1.8 mg daily or placebo', 'liraglutide', 'Liraglutide', 'Glucagon-like peptide-1 receptor agonist liraglutide', 'Glucagon-Like Peptide-1 Receptor Agonist Liraglutide', 'placebo']","['MR-proANP', 'NT-proBNP', 'MR-proANP and NT-proBNP levels', 'A- and B-type natriuretic peptides', 'MR-proADM', 'concomitant diagnosis of T2D. Plasma levels of NT-proBNP (predefined secondary endpoint), MR-proANP, midregional-pro-adrenomedullin (MR-proADM) and copeptin']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",231.0,0.132527,"There was no effect of liraglutide on MR-proADM (P=0.10) or copeptin (P=0.52).
","[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jorsal', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rasmus Stilling', 'Initials': 'RS', 'LastName': 'Tougaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jon Jarløv', 'Initials': 'JJ', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbaek', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Fredriksberg University Hospital, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Endocrinology, Herlev-Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Flyvbjerg', 'Affiliation': 'Steno Diabetes Center, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center Sjaelland, Holbaek, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14135']
2087,32627277,Placebo Effect in Chronic Inflammatory Demyelinating Polyneuropathy: The PATH study and a systematic review.,"Background and Aims The PATH study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG). Nineteen of the 51 subjects (37%) randomized to placebo did not relapse over the next 24 weeks. This article explores the reasons for this effect. A post-hoc analysis of the PATH placebo group was undertaken. A literature search identified other placebo controlled CIDP trials for review and comparison. In PATH, subjects randomized to placebo who did not relapse were significantly older, had more severe disease, and took longer to deteriorate in the IgG dependency period compared with those who relapsed. Published trials in CIDP, whose primary endpoint was stability or deterioration, had a mean non-deterioration (placebo effect) of 43%, while trials with a primary endpoint of improvement had a placebo response of only 11%. Interpretation Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration. This article is protected by copyright. All rights reserved.",2020,Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration.,"['Nineteen of the 51 subjects (37%) randomized to', 'Chronic Inflammatory Demyelinating Polyneuropathy', 'subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to']","['subcutaneous immunoglobulin (SCIG', 'Placebo', 'PATH placebo', 'placebo']",['stability or deterioration'],"[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0393819', 'cui_str': 'Chronic inflammatory demyelinating polyradiculoneuropathy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}]",51.0,0.638825,Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration.,"[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Gens', 'Initials': 'G', 'LastName': 'Sobue', 'Affiliation': 'Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring, Marburg, Pennsylvania, USA.'}, {'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'CSL Behring, Marburg, Pennsylvania, USA.'}, {'ForeName': 'Billie L', 'Initials': 'BL', 'LastName': 'Durn', 'Affiliation': 'CSL Behring, Marburg, Pennsylvania, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands and Curaçao Medical Center, Curaçao.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Meridian HealthComms Ltd, Manchester, UK.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Cleasby', 'Affiliation': 'Meridian HealthComms Ltd, Manchester, UK.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands and Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12402']
2088,32635406,Modulation of Phenylalanine and Tyrosine Metabolism in HIV-1 Infected Patients with Neurocognitive Impairment: Results from a Clinical Trial.,"To investigate the effects of oral bacteriotherapy on intestinal phenylalanine and tyrosine metabolism, in this longitudinal, double-arm trial, 15 virally suppressed HIV+ individuals underwent blood and fecal sample collection at baseline and after 6 months of oral bacteriotherapy. A baseline fecal sample was collected from 15 healthy individuals and served as control group for the baseline levels of fecal phenylalanine and tyrosine. CD4 and CD8 immune activation (CD38 + ) was evaluated by flow cytometry. Amino acid evaluation on fecal samples was conducted by Proton Nuclear Magnetic Resonance. Results showed that HIV+ participants displayed higher baseline phenylalanine/tyrosine ratio values than healthy volunteers. A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy. In conclusion, probiotics beneficially affect the immune activation of HIV+ individuals. Therefore, the restoration of intestinal amino acid metabolism could represent the mechanisms through which probiotics exert these desirable effects.",2020,A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy.,"['HIV-1 Infected Patients with Neurocognitive Impairment', '15 virally suppressed HIV+ individuals underwent blood and fecal sample collection at baseline and after 6 months of oral bacteriotherapy', '15 healthy individuals and served as control group for the baseline levels of fecal phenylalanine and tyrosine']","['oral bacteriotherapy', 'Phenylalanine and Tyrosine Metabolism']","['baseline phenylalanine/tyrosine ratio values', 'phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation', 'CD4 and CD8 immune activation (CD38 + ']","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0200345', 'cui_str': 'Specimen collection'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",15.0,0.0875068,A significand reduction in phenylalanine/tyrosine ratio and peripheral CD4 +  CD38 +  activation was observed at the end of oral bacteriotherapy.,"[{'ForeName': 'Giuseppe P', 'Initials': 'GP', 'LastName': 'Innocenti', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Santinelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Laghi', 'Affiliation': 'Department of Agro-Food Science and Technology, University of Bologna, Viale Fanin 46, 40127 Bologna, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Borrazzo', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pinacchio', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Fratino', 'Affiliation': 'Department of Neurology Sapienza, University of Rome, Piazzale Aldo Moro 5, 00185 Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Celani', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Eugenio N', 'Initials': 'EN', 'LastName': 'Cavallari', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Scagnolari', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Frasca', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Laboratory of Virology, Department of Molecular Medicine, Affiliated to Istituto Pasteur Italia-Cenci Bolognetti Foundation, Sapienza, University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'Mastroianni', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': ""d'Ettorre"", 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ceccarelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza, University of Rome, viale del Policlinico 155, 00161 Rome, Italy.'}]",Metabolites,['10.3390/metabo10070274']
2089,32635408,"A Double-Blind, Randomized, Placebo-Controlled Trial of Heat-Killed  Pediococcus acidilactici  K15 for Prevention of Respiratory Tract Infections among Preschool Children.","Although some probiotic bacteria have been reported to prevent infections in children, there are few well-designed double-blind studies. Here we evaluated the effects of a probiotic strain of lactic acid bacteria (LAB),  Pediococcus acidilactici  K15, on viral respiratory tract infections in preschool children. A four-month, randomized, double-blind, placebo-controlled study was performed in 172 healthy children aged 3 to 6 years. Subjects were administered dextrin alone or dextrin including heat-killed K15 (5 × 10 10  bacteria). The number of febrile days was the primary outcome. The number of absent days from preschools and the influenza incidence were secondary outcomes. Secretory IgA (sIgA) concentrations in saliva were measured as an exploratory outcome. The primary and secondary outcomes were not significantly different between both groups. Analyses in children with little intake of fermented foods including LAB showed that the duration of a fever significantly decreased by K15 intake. The salivary sIgA level in the K15 group was maintained significantly higher than it was in the placebo group. The effects of K15 on preventing viral respiratory tract infections were not observed without the restriction of fermented foods intake. However, K15 supported anti-infectious immune systems in children who took less fermented foods and the maintenance of salivary sIgA levels in all subjects.",2020,The salivary sIgA level in the K15 group was maintained significantly higher than it was in the placebo group.,"['Preschool Children', '172 healthy children aged 3 to 6 years', 'preschool children']","['probiotic strain of lactic acid bacteria (LAB),  Pediococcus acidilactici', 'dextrin alone or dextrin including heat-killed K15', 'Placebo', 'placebo']","['viral respiratory tract infections', 'number of febrile days', 'salivary sIgA levels', 'salivary sIgA level', 'duration of a fever', 'Respiratory Tract Infections', 'Secretory IgA (sIgA) concentrations in saliva']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1210581', 'cui_str': 'Lactobacillales'}, {'cui': 'C0445653', 'cui_str': 'Pediococcus acidilactici'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877203', 'cui_str': 'Respiratory tract infection viral'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",172.0,0.420595,The salivary sIgA level in the K15 group was maintained significantly higher than it was in the placebo group.,"[{'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Hishiki', 'Affiliation': 'Department of Pediatrics, Chiba University Hospital, Chiba 260-8670, Japan.'}, {'ForeName': 'Tadaomi', 'Initials': 'T', 'LastName': 'Kawashima', 'Affiliation': 'Research and Development Division, Kikkoman Corporation, Chiba 278-0037, Japan.'}, {'ForeName': 'Noriko M', 'Initials': 'NM', 'LastName': 'Tsuji', 'Affiliation': 'Biomedical Research Institute, National Institute of Advanced Industrial Science and Technology, Ibaraki 305-0046, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ikari', 'Affiliation': 'Research and Development Division, Kikkoman Corporation, Chiba 278-0037, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Takemura', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba 260-8677, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kido', 'Affiliation': 'Institute for Enzyme Research, Tokushima University, Tokushima 770-8503, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Shimojo', 'Affiliation': 'Department of Pediatrics, Chiba University Hospital, Chiba 260-8670, Japan.'}]",Nutrients,['10.3390/nu12071989']
2090,32635429,A Review of Topical Phage Therapy for Chronically Infected Wounds and Preparations for a Randomized Adaptive Clinical Trial Evaluating Topical Phage Therapy in Chronically Infected Diabetic Foot Ulcers.,"The advent and increasing prevalence of antimicrobial resistance commensurate with the absence of novel antibiotics on the horizon raises the specter of untreatable infections. Phages have been safely administered to thousands of patients exhibiting signals of efficacy in many experiencing infections refractory to antecedent antibiotics. Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers. We will initially provide results from a systematic literature review of topical phage therapy used clinically in refractorily infected chronic wounds. We will then segue into a synopsis of the preparations for a forthcoming phase II a randomized placebo-controlled clinical trial assessing the therapeutic efficacy exploiting adjunctive personalized phage administration, delivered topically, intravenously (IV) and via a combination of both modalities (IV + topical) in the treatment of infected diabetic foot ulcers (perhaps the canonical paradigm representing complicated recalcitrant infected cutaneous wounds).",2020,"Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers.","['infected diabetic foot ulcers (perhaps the canonical paradigm representing complicated recalcitrant infected cutaneous wounds', 'Chronically Infected Diabetic Foot Ulcers', 'Chronically Infected Wounds and Preparations']","['Topical phage therapy', 'Topical Phage Therapy', 'placebo']",[],"[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4277645', 'cui_str': 'Bacteriophage Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0417629,"Topical phage therapy may represent a convenient and efficacious treatment modality for chronic refractory infected cutaneous wounds spanning all classifications including venous stasis, burn-mediated, and diabetic ulcers.","[{'ForeName': 'Christopher Anthony', 'Initials': 'CA', 'LastName': 'Duplessis', 'Affiliation': 'Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Biswas', 'Affiliation': 'Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9070377']
2091,32635494,Phytoplankton Supplementation Lowers Muscle Damage and Sustains Performance across Repeated Exercise Bouts in Humans and Improves Antioxidant Capacity in a Mechanistic Animal.,"The purpose of this study was to investigate the impact of antioxidant-rich marine phytoplankton supplementation (Oceanix, OCX) on performance and muscle damage following a cross-training event in endurance-trained subjects. Additionally, an animal model was carried out to assess the effects of varying dosages of OCX, with exercise, on intramuscular antioxidant capacity.
METHODS


In the human trial, endurance-trained subjects (average running distance = 29.5 ± 2.6 miles × week -1 ) were randomly divided into placebo (PLA) and OCX (25 mg) conditions for 14 days. The subjects were pre-tested on a one-mile uphill run, maximal isometric strength, countermovement jump (CMJ) and squat jump (SJ) power, and for muscle damage (creatine kinase (CK)). On Day 12, the subjects underwent a strenuous cross-training event. Measures were reassessed on Day 13 and 14 (24 h and 48 h Post event). In the animal model, Wistar rats were divided into four groups ( n  = 7): (i) Control (no exercise and placebo (CON)), (ii) Exercise (E), (iii) Exercise + OCX 1 (Oceanix, 2.55 mg/day, (iv) Exercise + OCX 2 (5.1 mg/day). The rats performed treadmill exercise five days a week for 6 weeks. Intramuscular antioxidant capacity (superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GSH-Px)) and muscle damage (CK and myoglobin (MYOB) were collected. The data were analyzed using repeated measures ANOVA and  t -test for select variables. The alpha value was set at  p  < 0.05.
RESULTS


For the human trial, SJ power lowered in PLA relative to OCX at 24 h Post (-15%,  p  < 0.05). Decrements in isometric strength from Pre to 48 h Post were greater in the PLA group (-12%,  p  < 0.05) than in the OCX. Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05). For the animal trial, the intramuscular antioxidant capacity was increased in a general dose-dependent manner (E + Oc2 > E + Oc1 > E > CON). Additionally, CK and MYOB were lower in supplemented compared to E alone.
CONCLUSIONS


Phytoplankton supplementation (Oceanix) sustains performance and lowers muscle damage across repeated exercise bouts. The ingredient appears to operate through an elevating oxidative capacity in skeletal muscle.",2020,"Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05).","['endurance-trained subjects', 'human trial, endurance-trained subjects (average running distance = 29.5 ± 2.6 miles × week -1 ', 'Wistar rats were divided into four groups ( n  = 7']","['OCX 1 (Oceanix, 2.55 mg/day, (iv) Exercise ', 'OCX', 'antioxidant-rich marine phytoplankton supplementation (Oceanix, OCX', 'Phytoplankton Supplementation', 'i) Control (no exercise and placebo (CON)), (ii) Exercise (E), (iii', ' Exercise ', 'placebo (PLA) and OCX']","['Serum CK levels', 'intramuscular antioxidant capacity', 'maximal isometric strength, countermovement jump (CMJ) and squat jump (SJ) power, and for muscle damage (creatine kinase (CK', 'CK and MYOB', 'Intramuscular antioxidant capacity (superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GSH-Px)) and muscle damage (CK and myoglobin (MYOB', 'isometric strength']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034716', 'cui_str': 'Wistar rat'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0031865', 'cui_str': 'Phytoplankton'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}]",,0.0452336,"Serum CK levels were greater in the PLA compared to the OCX (+14%,  p  < 0.05).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sharp', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Kazim', 'Initials': 'K', 'LastName': 'Sahin', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stefan', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Orhan', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Raad', 'Initials': 'R', 'LastName': 'Gheith', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Dallen', 'Initials': 'D', 'LastName': 'Reber', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Nurhan', 'Initials': 'N', 'LastName': 'Sahin', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Tuzcu', 'Affiliation': 'Animal Nutrition Department, School of Veterinary Medicine, Firat University, Elazig 23200, Turkey.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lowery', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Durkee', 'Affiliation': 'Lonza Consumer Health Inc., Morristown, NJ 07960, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'The Applied Science & Performance Institute, Research Division, Tampa, FL 33607, USA.'}]",Nutrients,['10.3390/nu12071990']
2092,32636043,Early Mobilization After Volar Locking Plate Osteosynthesis of Distal Radial Fractures in Older Patients-A Randomized Controlled Trial.,"PURPOSE


To investigate if early mobilization after open reduction internal fixation of distal radius fractures improved the functional outcome. We hypothesized that early mobilization would lead to improved patient-reported outcome. Second, we aimed to assess whether early mobilization increased the risk of postoperative implant loosening or breakage.
METHODS


All included patients were treated with a volar locking plate. After surgery, patients were randomized to either early mobilization (E-MOB) with a removable orthosis (wrist lacer) and daily wrist exercises or to late mobilization (L-MOB) with a standard dorsal plaster cast for 2 weeks and, after that, a removable orthosis and exercises. We measured all patients at 4 weeks and at 3, 6, and 12 months after surgery. At each postoperative visit, we measured range of motion and grip strength and patients filled out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Radiographic implant loosening or breakage was assessed 14 days after surgery.
RESULTS


A total of 47 patients were allocated to E-MOB and 48 to L-MOB. The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point. Implant loosening and fracture redisplacement was observed in 1 patient in the E-MOB group. Range of motion and grip strength were similar between the 2 groups at all time points.
CONCLUSIONS


Early mobilization after surgical treatment of distal radius fractures does not lead to improved patient-reported outcome.
TYPE OF STUDY/LEVEL OF EVIDENCE


Therapeutic I.",2020,The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point.,"['47 patients', 'Older Patients']","['Volar Locking Plate Osteosynthesis', 'early mobilization (E-MOB) with a removable orthosis (wrist lacer) and daily wrist exercises or to late mobilization (L-MOB) with a standard dorsal plaster cast', 'volar locking plate']","['range of motion and grip strength and patients filled out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Implant loosening and fracture redisplacement', 'Early Mobilization', 'Radiographic implant loosening or breakage', 'DASH score', 'Range of motion and grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454328', 'cui_str': 'Wrist exercises'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0032159', 'cui_str': 'Plaster cast'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0688753,The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point.,"[{'ForeName': 'Thomas Juul', 'Initials': 'TJ', 'LastName': 'Sørensen', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ohrt-Nissen', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge. Electronic address: ohrtnissen@gmail.com.'}, {'ForeName': 'Kecia V', 'Initials': 'KV', 'LastName': 'Ardensø', 'Affiliation': 'Department of Occupational and Physiotherapy, Zealand University Hospital, Køge.'}, {'ForeName': 'Gunnar H', 'Initials': 'GH', 'LastName': 'Laier', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Denmark.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Mallet', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.05.009']
2093,32636099,Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).,"BACKGROUND


Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty.
OBJECTIVE


To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.
DESIGN, SETTING, AND PARTICIPANTS


This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy.
INTERVENTION


Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention.
RESULTS AND LIMITATIONS


The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89]).
CONCLUSIONS


In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.
PATIENT SUMMARY


There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.",2020,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"['adult men with recurrent bulbar urethral stricture', 'UK National Health Service hospitals were recruited and 222 men', 'Recurrent Bulbar Urethral Stricture', 'men with recurrent bulbar urethral stricture']","['urethrotomy and urethroplasty', 'urethrotomy with open urethroplasty', 'Urethrotomy', 'urethroplasty or urethrotomy', 'Open Urethroplasty Versus Endoscopic Urethrotomy']","['voiding symptom score', 'reinterventions', 'time until reintervention', 'voiding symptoms', 'effectiveness and cost-effectiveness', 'symptom scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0194550', 'cui_str': 'Incision of urethra'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",222.0,0.165454,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Carnell', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Breckons', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@ncl.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Whybrow', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forbes', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Currer', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Andrich', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mundy', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'Central Manchester Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Watkin', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",European urology,['10.1016/j.eururo.2020.06.003']
2094,32636109,Repeat Doses of Dexamethasone up to 48 Hours Further Reduce Pain and Inflammation After Total Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


The optimal dose regimen of dexamethasone in total hip arthroplasty (THA) is unclear. This study was conducted to compare the effects among 1-dose, 2-dose, and 3-dose dexamethasone in THA.
METHODS


One hundred fifty patients were randomized to receive a single preoperative dose of 10-mg dexamethasone (group A, 50 patients), or another dose of 10-mg dexamethasone 24 hours later (group B, 50 patients), or another 2 doses of 10-mg dexamethasone 24 and 48 hours later (group C, 50 patients). The primary outcome was postoperative pain level. The use of analgesic and antiemetic rescue; incidence of postoperative nausea and vomiting; C-reactive protein and interleukin-6 levels; range of motion; and complications were also compared.
RESULTS


The dynamic pain scores were lower for groups B and C compared to group A on postoperative days 2 and 3. Such difference was also detected between groups B and C on postoperative day 3. C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively. Such difference was also observed between groups B and C at 72 hours postoperatively. Patients in groups B and C had reduced rescue analgesic use, and improved range of motion compared to patients in group A. There were no differences among 3 groups regarding the rescue antiemetic use, postoperative nausea and vomiting occurrence, and complications.
CONCLUSION


Additional administrations of dexamethasone after THA could provide sustained pain relief and inflammatory control. Besides, the 3-dose regimen was more effective than the 2-dose regimen in terms of the analgesic and anti-inflammatory effects.
LEVEL OF EVIDENCE


I.",2020,C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively.,"['After Total Hip Arthroplasty', 'total hip arthroplasty (THA', 'One hundred fifty patients']","['dexamethasone', 'Dexamethasone', '10-mg dexamethasone']","['dynamic pain scores', 'postoperative pain level', 'rescue antiemetic use, postoperative nausea and vomiting occurrence, and complications', 'C-reactive protein and interleukin-6 levels', 'Pain and Inflammation', 'sustained pain relief and inflammatory control', 'range of motion']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",150.0,0.182866,C-reactive protein and interleukin-6 levels were lower in groups B and C than in group A at 48 and 72 hours postoperatively.,"[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China; Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.023']
2095,32636128,Administration of eicosapentaenoic acid may alter lipoprotein particle heterogeneity in statin-treated patients with stable coronary artery disease: A pilot 6-month randomized study.,"BACKGROUND


We hypothesized that the addition of eicosapentaenoic acid (EPA) to ongoing statin therapy could change the particle heterogeneity of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) particles, even in stable coronary artery disease (CAD) patients.
METHODS


We assigned CAD patients already receiving statin therapy to one of two groups: an EPA group (1800 mg/day; n = 30) and a control group (n = 30). A gel permeation high-performance liquid chromatography method was used to measure the particle concentration and number of lipoprotein subclasses.
RESULTS


In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed. Conversely, the concentration and number of large HDL particles increased significantly (p = 0.024 and 0.048). The concentration of very large HDL particles also increased significantly (p = 0.028). Furthermore, significant correlations between the variables that showed significant changes in the LDL and HDL particle subclasses, and the EPA/arachidonic acid (AA) ratio were found. No other significant associations of lipoprotein particle heterogeneity with the serum EPA/AA ratio were noted in either the control group or the EPA group. Interestingly, univariate and multivariate regression analyses revealed that increased serum lecithin-cholesterol acyltransferase activity, a key enzyme of HDL cholesterol efflux, was a predictor for increased above-mentioned HDL particles subclasses.
CONCLUSIONS


Administration of EPA might alter both LDL and HDL particle heterogeneity, causing decreased concentration and number of smaller LDL particles and increased concentration and number of larger HDL particles. Furthermore, addition of EPA to ongoing statin therapy appears to be capable of increasing the EPA/AA ratio, which might have an anti-atherosclerotic effect on lipoprotein particle heterogeneity, even in stable CAD patients with well-controlled serum lipid levels.
CLINICAL TRIAL REGISTRATION


UMIN (http://www.umin.ac.jp/) Study ID: UMIN000010452.",2020,"In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed.","['stable coronary artery disease (CAD) patients', 'statin-treated patients with stable coronary artery disease']","['eicosapentaenoic acid', 'EPA', 'eicosapentaenoic acid (EPA', 'statin therapy']","['concentration and number of large HDL particles', 'concentration and number of larger HDL particles', 'concentration of very large HDL particles', 'lipoprotein particle heterogeneity with the serum EPA/AA ratio', 'small LDL', 'lipoprotein particle heterogeneity', 'concentration and number of medium LDL', 'LDL and HDL particle subclasses, and the EPA/arachidonic acid (AA) ratio', 'serum lecithin-cholesterol acyltransferase activity, a key enzyme of HDL cholesterol efflux', 'low-density lipoprotein (LDL) and high-density lipoprotein (HDL) particles']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0023194', 'cui_str': 'Phosphatidylcholine-sterol acyltransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0653798,"In the EPA group, significant decreases of both the concentration and number of medium LDL (p = 0.0002 and 0.0001), small LDL (p = 0.0004 and 0.0005) and very small LDL (p = 0.0005 and 0.002) particles were observed.","[{'ForeName': 'Shigemasa', 'Initials': 'S', 'LastName': 'Tani', 'Affiliation': 'Department of Health Planning Center, Nihon University Hospital, Tokyo Japan; Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan. Electronic address: tani.shigemasa@nihon-u.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Yagi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Matsuo', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kawauchi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Atsumi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan; Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.06.006']
2096,32636290,"High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study.","INTRODUCTION


The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.
METHODS AND ANALYSIS


This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.
ETHICS AND DISSEMINATION


Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.
TRIAL REGISTRATION NUMBER


NCT04042311; Pre-results.",2020,High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier.,"['patients with intermittent claudication (IC', '40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week', 'patients with IC']","['High INtensity Interval Training', 'supervised exercise programme (SEP', 'HIIT programme', 'High-intensity interval training (HIIT']","['safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity', 'patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes', 'provision, uptake and adherence rates', 'safety, feasibility, tolerability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",40.0,0.212284,High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pymer', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK sean.pymer@hey.nhs.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harwood', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, New South Wales, UK.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Ibeggazene', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McGregor', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, New South Wales, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Twiddy', 'Affiliation': 'Institute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Rooms', 'Affiliation': 'Hull, UK.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Chetter', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038825']
2097,32636292,"Immediate parent-infant skin-to-skin study (IPISTOSS): study protocol of a randomised controlled trial on very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences.","INTRODUCTION


In Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother's warmth, nutrition and other benefits. Preterm infants face health and neurodevelopment challenges that may also affect the family and society at large. There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
METHODS AND ANALYSIS


In this ongoing randomised controlled trial from Stavanger, Norway and Stockholm, Sweden, we are studying 150 infants born at 28+0 to 32+6 gestational weeks, randomised to receive care immediately after birth in SSC with a parent or conventionally in an incubator. The primary outcome is cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score. Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health.
ETHICS AND DISSEMINATION


The study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019-03361) and the Norwegian Regional Ethical Committee (2015/889). The study is conducted according to good clinical practice and the Helsinki declaration. The results of the study will increase the knowledge about the mechanisms behind the effects of SSC for very preterm infants by dissemination to the scientific community through articles and at conferences, and to the society through parenting classes and magazines.
STUDY STATUS


Recruiting since April 2018. Expected trial termination June 2021.
TRIAL REGISTRATION NUMBER


NCT03521310 (ClinicalTrials.gov).",2020,"There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
","['very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences', '150 infants born at 28+0 to 32+6 gestational weeks']",['care immediately after birth in SSC with a parent or conventionally in an incubator'],"['autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health', 'cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.13168,"There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Linnér', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden agnes.linner@ki.se.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Westrup', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Lode-Kolz', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Klemming', 'Affiliation': 'Neonatal Unit, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Lillieskold', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Markhus Pike', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Morgan', 'Affiliation': 'Global Risk Governance Programme, Law Faculty, University of Cape Town, Rondebosch, Western Cape, South Africa.'}, {'ForeName': 'Nils Johannes', 'Initials': 'NJ', 'LastName': 'Bergman', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Siren', 'Initials': 'S', 'LastName': 'Rettedal', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Jonas', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}]",BMJ open,['10.1136/bmjopen-2020-038938']
2098,32636318,"A phase II trial of tipifarnib for patients with previously-treated, metastatic urothelial carcinoma harboring HRAS mutations.","PURPOSE


To assess the antitumor activity and safety of tipifarnib, a highly potent and selective farnesyltransferase inhibitor, we performed a phase II clinical trial in patients with advanced and refractory urothelial carcinoma (UC) harboring missense HRAS mutations.
EXPERIMENTAL DESIGN


A total of 245 adult patients with previously-treated, advanced UC entered the molecular screening program including HRAS. Those with missense HRAS mutations or STK11:rs2075606 received oral tipifarnib 900 mg bid on days 1-7 and 15-21 of 28-day treatment cycles. The primary endpoint was progression-free survival at 6 months (PFS6).
RESULTS


We identified 16 (7%) missense HRAS mutations (G13R, 7; Q61R, 4; G12S, 3; G12C, 2) and 104 (46%) STK11: rs2075606 carriers. In 21 patients enrolled in the study, 14 and 7 patients had missense HRAS mutations and STK11:rs2075606, respectively. The most frequently observed adverse events included fatigue (86%) and hematologic toxicities. With a median follow-up of 28 months, 4 patients (19%) reached PFS6: 3 had missense HRAS mutations and one patient, enrolled as a STK11 carrier, had HRAS frameshift insertions at H27fs and H28fs rendering a nonsense HRAS mutation. The ORR by intent-to-treat analysis was 24% (4 missense and one nonsense frameshift HRAS mutation); no response observed in UC patients with wild type HRAS tumors. Five responses were observed in 12 evaluable patients of 15 with tumors carrying HRAS mutations.
CONCLUSION


Oral tipifarnib resulted in manageable safety profile and encouraging antitumor efficacy against treatment-refractory UC containing HRAS mutations.",2020,no response observed in UC patients with wild type HRAS tumors.,"['12 evaluable patients of 15 with tumors carrying HRAS mutations', '245 adult patients with previously-treated, advanced UC entered the molecular screening program including HRAS', 'patients with previously-treated, metastatic urothelial carcinoma harboring HRAS mutations', 'UC patients with wild type HRAS tumors', '21 patients enrolled in the study, 14 and 7 patients had missense HRAS mutations and STK11:rs2075606, respectively', 'patients with advanced and refractory urothelial carcinoma (UC) harboring missense HRAS mutations']","['oral tipifarnib', 'tipifarnib', 'STK11']","['antitumor activity and safety', 'hematologic toxicities', 'progression-free survival at 6 months (PFS6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1619700', 'cui_str': 'Renal aplasia'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176289', 'cui_str': 'tipifarnib'}, {'cui': 'C1431123', 'cui_str': 'STK11 protein, human'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",245.0,0.0317373,no response observed in UC patients with wild type HRAS tumors.,"[{'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Hospital Medicine, Yonsei University College of Medicine.'}, {'ForeName': 'Jason Kyungha', 'Initials': 'JK', 'LastName': 'Sa', 'Affiliation': 'Research Institute for Future Medicine, Samsung Medical Center.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gualberto', 'Affiliation': 'Kura Oncology (United States).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Scholz', 'Affiliation': 'Kura Oncology (United States).'}, {'ForeName': 'Hyun Hwan', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Samsung Medical Center.'}, {'ForeName': 'Byong Chang', 'Initials': 'BC', 'LastName': 'Jeong', 'Affiliation': 'Samsung Medical Center.'}, {'ForeName': 'Han Yong', 'Initials': 'HY', 'LastName': 'Choi', 'Affiliation': 'Department of urology, Sungkyunkwan University School of Medicine.'}, {'ForeName': 'Ghee Young', 'Initials': 'GY', 'LastName': 'Kwon', 'Affiliation': 'Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine hematoma@skku.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1246']
2099,32636319,Serum alpha-fetoprotein levels and clinical outcome in the phase 3 CELESTIAL study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma.,"Purpose The phase 3 CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes. Experimental design Serum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics. Results Median OS for cabozantinib versus placebo was 13.9 versus 10.3 months (HR, 0.81; 95% CI, 0.62-1.04) for patients with baseline AFP <400 ng/mL, and 8.5 versus 5.2 months (HR, 0.71; 95% CI, 0.54-0.94) for patients with baseline AFP ≥400 ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo. In the cabozantinib arm, median OS for patients with and without AFP response was 16.1 versus 9.1 months (HR, 0.61; 95% CI, 0.45-0.84). AFP response was independently associated with longer OS. The optimal cutoff for association with OS in the cabozantinib arm was ≤0% change in AFP at Week 8 (AFP control; HR 0.50 [95% CI, 0.35-0.71]). HRs for PFS were consistent with those for OS. Conclusions Cabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.",2020,ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo.,"['patients with previously treated, advanced hepatocellular carcinoma (HCC', '≥400', 'patients with advanced hepatocellular carcinoma']","['cabozantinib versus placebo', 'placebo']","['Median OS', 'median OS', 'AFP response rate', 'AFP response and control rates', 'AFP response', 'overall survival (OS) and progression-free survival (PFS', 'Serum alpha-fetoprotein levels and clinical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1287375', 'cui_str': 'Serum alpha-fetoprotein level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.249652,ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo.,"[{'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco katie.kelley@ucsf.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'UCL Cancer Institute, University College London.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center - IRCCS; Department of Biomedical Sciences, Humanitas University.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""Groupement Hospitalier Lyon Nord, Service d'Hépatologie, Hospices Civils de Lyon.""}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, Goyang-si, Republic of Korea.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Queen Mary Hospital.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'Clinical Oncology, Chinese University of Hong Kong, State Key Laboratory of South China.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hepato-Gastroenterology and Digestive Oncology, University Hospital Of Bordeaux.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Tam', 'Affiliation': '1331 29th Street NW, Tom Baker Cancer Centre, University of Calgary.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': ""Groupe Hospitalier L'Archet.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Dadduzio', 'Affiliation': 'Department of Oncology, Veneto Institute of Oncology IOV - IRCCS.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Markby', 'Affiliation': 'Medical Affairs, Exelixis, Inc.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kaldate', 'Affiliation': 'Exelixis, Inc.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Graduate Institute of Oncology, National Taiwan University.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Division of Medical Oncology, USC Norris Comprehensive Cancer Center.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Gastrointestinal Oncology Service, Dept. of Medicine, Memorial Sloan Kettering Cancer Center.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3884']
2100,32636324,One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study.,"OBJECTIVE


To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.
METHODS


Patients were randomized ( n =955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg. At Week 24, 845 patients were re-randomized (1:1) to erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75% and 100% reduction in MMD, and safety/tolerability were assessed.
RESULTS


Mean MMD at DBTP baseline was 8.3. At Week 52, mean changes (SE) from pre-DBTP baseline/Week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70mg) and -4.6 (0.2)/-1.8 (0.2) (140mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70mg (ATP), change in MMD from Week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140mg (ATP) was -1.8 (0.3). At Week 52, 61.0%, 38.5% and 19.8% of patients on erenumab 70mg, and 64.9%, 40.8% and 21.2% on erenumab 140mg, achieved ≥50%, ≥75% and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in the ATP was similar to the DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.
CONCLUSION


Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
CLINICALTRIALSGOV IDENTIFIER


NCT02456740 CLASSIFICATION OF EVIDENCE: Class II evidence that 52 weeks of treatment with erenumab 70 and 140mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.",2020,"Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
","['845 patients', 'patients with episodic migraine', 'Patients were randomized ( n =955; 1:1:1) during the 24-week', 'episodic migraine']","['erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP', 'double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg']","['safety profiles', 'MMD, and safety/tolerability', 'efficacy and tolerability', 'sustained responses', 'MMD', 'Mean MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",845.0,0.0624176,"Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College Hospital, London, UK peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': 'Neuro Center, St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': 'Mercy Research, Saint Louis, MO, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ian K', 'Initials': 'IK', 'LastName': 'Wright', 'Affiliation': 'Novartis Product Irl Ltd, Dublin, Ireland.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Chou', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Neurology,['10.1212/WNL.0000000000010019']
2101,32636360,"Intranasal oxytocin modulates brain responses to voice-identity recognition in typically developing individuals, but not in ASD.","Faces and voices are prominent cues for person-identity recognition. Face recognition behavior and associated brain responses can be enhanced by intranasal administration of oxytocin. It is unknown whether oxytocin can also augment voice-identity recognition mechanisms. To find it out is particularly relevant for individuals who have difficulties recognizing voice identity such as individuals diagnosed with autism spectrum disorder (ASD). We conducted a combined behavioral and functional magnetic resonance imaging (fMRI) study to investigate voice-identity recognition following intranasal administration of oxytocin or placebo in a group of adults diagnosed with ASD (full-scale intelligence quotient > 85) and pairwise-matched typically developing (TD) controls. A single dose of 24 IU oxytocin was administered in a randomized, double-blind, placebo-controlled and cross-over design. In the control group, but not in the ASD group, administration of oxytocin compared to placebo increased responses to recognition of voice identity in contrast to speech in the right posterior superior temporal sulcus/gyrus (pSTS/G) - a region implicated in the perceptual analysis of voice-identity information. In the ASD group, the right pSTS/G responses were positively correlated with voice-identity recognition accuracy in the oxytocin condition, but not in the placebo condition. Oxytocin did not improve voice-identity recognition performance at the group level. The ASD compared to the control group had lower right pSTS/G responses to voice-identity recognition. Since ASD is known to have atypical pSTS/G, the results indicate that the potential of intranasal oxytocin to enhance mechanisms for voice-identity recognition might be variable and dependent on the functional integrity of this brain region.",2020,"In the control group, but not in the ASD group, administration of oxytocin compared to placebo increased responses to recognition of voice identity in contrast to speech in the right posterior superior temporal sulcus/gyrus (pSTS/G) - a region implicated in the perceptual analysis of voice-identity information.","['adults diagnosed with ASD (full-scale intelligence quotient\u2009>\u200985) and pairwise-matched typically developing (TD) controls', 'individuals who have difficulties recognizing voice identity such as individuals diagnosed with autism spectrum disorder (ASD']","['oxytocin', 'combined behavioral and functional magnetic resonance imaging (fMRI', 'oxytocin or placebo', 'Intranasal oxytocin', 'Oxytocin', '24 IU oxytocin', 'placebo']","['voice-identity recognition performance', 'right pSTS/G responses', 'voice-identity recognition accuracy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C4046107', 'cui_str': 'Identity Recognition'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.132279,"In the control group, but not in the ASD group, administration of oxytocin compared to placebo increased responses to recognition of voice identity in contrast to speech in the right posterior superior temporal sulcus/gyrus (pSTS/G) - a region implicated in the perceptual analysis of voice-identity information.","[{'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Borowiak', 'Affiliation': 'Technische Universität Dresden, Bamberger Straße 7, 01187, Dresden, Germany. kamila.borowiak@tu-dresden.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'von Kriegstein', 'Affiliation': 'Technische Universität Dresden, Bamberger Straße 7, 01187, Dresden, Germany.'}]",Translational psychiatry,['10.1038/s41398-020-00903-5']
2102,32636425,Effect of nano-hydroxyapatite and ozone on approximal initial caries: a randomized clinical trial.,"The aim of the study was to assess the efficacy of three methods of enamel remineralization on initial approximal caries: (1) a nano-hydroxyapatite gel, (2) gaseous ozone therapy, (3) combination of a nano-hydroxyapatite gel and ozone. Patients (n = 92, age 20-30 years) with initial approximal enamel lesions on premolar and molar teeth (n = 546) were randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both domestic remineralizing gel and ozone therapy. Caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years. At one-year follow-up, the smallest rate of lesions with remineralisation (36.5%) was found in group I, and the highest (69.3%)-in group III. In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years. Thus nano-hydroxyapatite gel and ozone therapy exert some capacities to remineralize approximal enamel and dentine subsurface lesions of premolar and molar teeth. Moreover, the combination of both methods produces the best effect compared to nano-hydroxyapatite or ozone therapy applied alone. However, the treatment should be continued for a long time in order to achieve nonrestorative recovery of caries.",2020,In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years.,"['92, age 20-30 years) with initial approximal enamel lesions on premolar and molar teeth (n\u2009=\u2009546', 'approximal initial caries', 'Patients (n\u2009']","['domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both domestic remineralizing gel and ozone therapy', 'hydroxyapatite gel and ozone therapy', 'enamel remineralization', 'nano-hydroxyapatite gel, (2) gaseous ozone therapy, (3) combination of a nano-hydroxyapatite gel and ozone', 'nano-hydroxyapatite and ozone']","['smallest rate of lesions with remineralisation', 'initial approximal caries', 'Caries lesions']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0266858', 'cui_str': 'Incipient enamel caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",546.0,0.0129443,In group III a significant remineralisation was noticed in after 1 year and then a demineralisation after 2 years.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Grocholewicz', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland. katarzyna.grocholewicz@pum.edu.pl.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Matkowska-Cichocka', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Makowiecki', 'Affiliation': 'Department of General and Dental Radiology, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Droździk', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Ey-Chmielewska', 'Affiliation': 'Department of Dental Prosthetics, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dziewulska', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Tomasik', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Trybek', 'Affiliation': 'Department of Dental Surgery, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Janiszewska-Olszowska', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University, Al. Powstańców Wielkopolskich 72, 70-111, Szczecin, Poland.'}]",Scientific reports,['10.1038/s41598-020-67885-8']
2103,32636444,Assessment of the effects of sugammadex on coagulation profiles using thromboelastographic parameters.,"This study evaluated the effects of sugammadex at conventional doses of 2 and 4 mg/kg on the coagulation profile by analyzing thromboelastographic parameters and performing a traditional laboratory coagulation analysis. A total of 100 patients undergoing arthroscopic shoulder surgery were enrolled. The patients were randomly divided into the 2 mg and 4 mg groups. The laboratory coagulation test and thromboelastographic analysis were performed before and 15 min after administering sugammadex. Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001). R time, derived from thromboelastography, was also significantly prolonged after sugammadex administration (4.7 ± 1.8 min vs. 5.8 ± 2.1 min, p = 0.005). In conclusion, the conventional doses of 2 or 4 mg/kg sugammadex prolonged PT. Sugammadex 4 mg/kg also prolonged R time, although the value was within the normal range. Therefore, physicians should be cautious with the higher sugammadex dose, particularly in patients with a high risk of bleeding because the higher dose was associated with less coagulation.Trial registration: KCT0002133 (https://cris.nih.go.kr).",2020,"Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001).",['100 patients undergoing arthroscopic shoulder surgery were enrolled'],['sugammadex'],['Prothrombin time (PT'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0033707', 'cui_str': 'Prothrombin time'}]",100.0,0.0407057,"Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001).","[{'ForeName': 'Woon-Seok', 'Initials': 'WS', 'LastName': 'Kang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Hoyoung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Byung-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Yeaji', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea.'}, {'ForeName': 'Kyung-Don', 'Initials': 'KD', 'LastName': 'Hahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, Ulasn University, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1, Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05030, Republic of Korea. yshkim75@daum.net.'}]",Scientific reports,['10.1038/s41598-020-68164-2']
2104,32636505,COVID-19 platform trial delivers.,,2020,,[],[],[],[],[],[],,0.0737369,,"[{'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Mullard', 'Affiliation': ''}]",Nature reviews. Drug discovery,['10.1038/d41573-020-00128-7']
2105,32636609,A Novel Method of Visual Field Assessment for Patients with Unilateral Severely Limited Central Vision: A Pilot Study.,"Purpose


Reliable visual field testing requires the tested eye to be fixated on a central target. This poses a major obstacle for eyes with severe central vision loss. This pilot study assesses whether it may be feasible to examine such patients with a modified method.
Methods


A green filter was placed over the fellow eye. A FASTPAC algorithm was used with a red stimulus. The green filter prevented transmission of the red stimuli but allowed visualization of the yellow fixation light. Subjects were tested by both the conventional and the novel method, performed in a randomized order. We compared the reliability indices and also the precision of the two methods.
Results


We present results from six patients. The novel method was associated with an 85% reduction in fixation losses (P=0.028) and a 58% reduction in eye motion on gaze tracking (P=0.007). Further, specialized testing in one of the volunteers demonstrated that the novel technique could more precisely define a small zone of preserved peripheral vision (P=0.008).
Conclusion


The results of this pilot study suggest that the novel method described may be a feasible strategy for visual field testing in patients with unilateral severe central vision loss.",2020,The novel method was associated with an 85% reduction in fixation losses (P=0.028) and a 58% reduction in eye motion on gaze tracking (P=0.007).,"['eyes with severe central vision loss', 'Patients with Unilateral Severely Limited Central Vision', 'patients with a modified method', 'patients with unilateral severe central vision loss']",['Visual Field Assessment'],"['fixation losses', 'eye motion on gaze tracking']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0152191', 'cui_str': 'Central scotoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}]",,0.044046,The novel method was associated with an 85% reduction in fixation losses (P=0.028) and a 58% reduction in eye motion on gaze tracking (P=0.007).,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stern', 'Affiliation': 'Department of Ophthalmology, Hadassah Medical Center, Kiryat Hadassah, Jerusalem 91120, Israel.'}, {'ForeName': 'Elhanan', 'Initials': 'E', 'LastName': 'Parnasa', 'Affiliation': 'Hebrew University-Hadassah School of Medicine, Jerusalem 91120, Israel.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Forer', 'Affiliation': 'Hebrew University-Hadassah School of Medicine, Jerusalem 91120, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Tessler', 'Affiliation': 'Hebrew University-Hadassah School of Medicine, Jerusalem 91120, Israel.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Kruger', 'Affiliation': 'Department of Ophthalmology, Hadassah Medical Center, Kiryat Hadassah, Jerusalem 91120, Israel.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S258949']
2106,32636658,Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study.,"Purpose


Although immune dysfunction has been investigated in adult septic patients, early immune status remains unclear. In this study, our primary aim was to assess early immune status in adult patients with sepsis stratified by age and its relevance to hospital mortality.
Patients and Methods


A post hoc analysis of a multicenter, randomized controlled trial was conducted; 273 patients whose immune status was evaluated within 48 hours after onset of sepsis were enrolled. Early immune status was evaluated by the percentage of monocyte human leukocyte antigen-DR (mHLA-DR) in total monocytes within 48 hours after onset of sepsis and it was classified as immunoparalysis (mHLA-DR ≤30%) or non-immunoparalysis (>30%). Three logistic regression models were conducted to explore the associations between early immunoparalysis and hospital mortality. We also developed two sensitivity analyses to find out whether the definition of early immune status (24 hours vs 48 hours after onset of sepsis) and immunotherapy affect the primary outcome.
Results


Of the 181 elderly (≥60yrs) and 92 non-elderly (<60yrs) septic patients, 71 (39.2%) and 25 (27.2%) died in hospital, respectively. The percentage of early immunoparalysis in the elderly was twice of that in the non-elderly patients (32% vs 16%, p=0.006). For the elderly, hospital mortality was higher in the immunoparalysis ones than the non-immunoparalysis ones (53.4% vs 32.5%, p=0.009). But there was no significant difference in hospital mortality between immunoparalysis non-elderly patients and non-immunoparalysis non-elderly ones (33.5% vs 26.0%, p=0.541). By means of logistic regression models, we found that early immunoparalysis was independently associated with increased hospital mortality in elderly, but not in non-elderly patients. Sensitivity analysis further confirmed the definition of early immune status and immunotherapy did not affect the outcomes.
Conclusion


The elderly were more susceptible to early immunoparalysis after onset of sepsis. Early immunoparalysis was independently associated with poor prognosis in elderly, but not in non-elderly patients.",2020,"But there was no significant difference in hospital mortality between immunoparalysis non-elderly patients and non-immunoparalysis non-elderly ones (33.5% vs 26.0%, p=0.541).","['adult patients with sepsis stratified by age and its relevance to hospital mortality', '273 patients whose immune status was evaluated within 48 hours after onset of sepsis were enrolled', '92 non-elderly (<60yrs) septic patients, 71 (39.2%) and 25 (27.2%) died in hospital, respectively', 'adult septic patients', 'Elderly Patients with Sepsis', '181 elderly (≥60yrs) and']",[],"['percentage of monocyte human leukocyte antigen-DR (mHLA-DR) in total monocytes', 'early immune status', 'hospital mortality', 'percentage of early immunoparalysis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C0420302', 'cui_str': 'Died in hospital'}]",[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",273.0,0.0367469,"But there was no significant difference in hospital mortality between immunoparalysis non-elderly patients and non-immunoparalysis non-elderly ones (33.5% vs 26.0%, p=0.541).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Guan-Rong', 'Initials': 'GR', 'LastName': 'Zhang', 'Affiliation': ""Information and Statistics Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'Zhou', 'Affiliation': ""Department of Critical Care Medicine, Foshan First Municipal People's Hospital, Foshan 528000, People's Republic of China.""}, {'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, Guangzhou First Municipal People's Hospital, Guangzhou 510180, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': ""Department of Critical Care Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou 510060, People's Republic of China.""}, {'ForeName': 'Qiu-Ye', 'Initials': 'QY', 'LastName': 'Kou', 'Affiliation': ""Department of Critical Care Medicine, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou 510655, People's Republic of China.""}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': ""Department of Critical Care Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, People's Republic of China.""}, {'ForeName': 'Min-Ying', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Wu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, People's Republic of China.""}, {'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Guan', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Infection and drug resistance,['10.2147/IDR.S246513']
2107,32636684,Efficacy of a Hybrid Toothbrush versus Comparative Manual Toothbrush for Plaque Removal - Randomized In-Use Study.,"Purpose


An innovative hybrid toothbrush was designed to function either in manual sonic mode or combined mode (manual and sonic). The primary objective was to assess the efficacy of a new hybrid powered toothbrush (PTB) used in combined mode versus a comparative manual toothbrush (MTB) for plaque removal, after 14 days of twice-daily use under normal conditions. The secondary objectives were to evaluate the gingival state, to evaluate the tolerance of the hybrid PTB and to evaluate its acceptability.
Materials and Methods


This study was a monocentric, block-randomized, dual treatment, parallel group, and examiner-blinded trial with before and after evaluation. It was conducted on two groups of 55 subjects presenting a visible plaque accumulation (score ≥2 as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI)). On Day 1/Day 8/Day 15, the same investigator conducted blind clinical examinations on each subject and evaluated TMQHPI and Papillary Bleeding Score (PBS). On Day 1, the subjects received either the hybrid PTB or the comparative MTB and used it twice daily under normal conditions of use.
Results


The hybrid PTB used in its combined mode eliminates dental plaque more efficiently than the comparative MTB, especially in difficult-to-access areas such as posterior and interproximal dental surfaces, while remaining gentle on the gingivae. The PBS was significantly lower with the hybrid toothbrush compared with the reference manual one.
Conclusion


The new device confirmed previous findings and should improve oral hygiene following the manufacturer's instructions. Moreover, the specific design of the toothbrush means that it can be used according to the oral environment conditions and personal feeling.",2020,"The hybrid PTB used in its combined mode eliminates dental plaque more efficiently than the comparative MTB, especially in difficult-to-access areas such as posterior and interproximal dental surfaces, while remaining gentle on the gingivae.",['55 subjects presenting a visible plaque accumulation (score ≥2 as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI'],"['new hybrid powered toothbrush (PTB', 'hybrid toothbrush', 'Hybrid Toothbrush versus Comparative Manual Toothbrush', 'comparative manual toothbrush (MTB', 'hybrid PTB or the comparative MTB']","['PBS', 'TMQHPI and Papillary Bleeding Score (PBS', 'oral hygiene', 'Plaque Removal']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",55.0,0.0187859,"The hybrid PTB used in its combined mode eliminates dental plaque more efficiently than the comparative MTB, especially in difficult-to-access areas such as posterior and interproximal dental surfaces, while remaining gentle on the gingivae.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Favrel', 'Affiliation': 'Innovation Unit, Clinical Department, Pierre Fabre Consumer Health Care, Castres, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Urbaniak', 'Affiliation': 'Dental Clinic, Gdansk, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Chabowska', 'Affiliation': 'Dermscan Poland, Gdansk, Poland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sirvent', 'Affiliation': 'Eurofins Dermscan, Villeurbanne, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Gatignol', 'Affiliation': 'Innovation Unit, Medical Department, Pierre Fabre Consumer Health Care, Castres, France.'}]","Clinical, cosmetic and investigational dentistry",['10.2147/CCIDE.S257411']
2108,32636739,Cognitive Enhancement  via  Neuromodulation and Video Games: Synergistic Effects?,"Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique able to modulate cortical excitability. This modulation may influence areas and networks responsible for specific cognitive processes, and the repetition of the induced temporary changes can produce long-lasting effects. TMS effectiveness may be enhanced when used in conjunction with cognitive training focused on specific cognitive functions. Playing video games can be an optimal cognitive training since it involves different cognitive components and high levels of engagement and motivation. The goal of this study is to assess the synergistic effects of TMS and video game training to enhance cognition, specifically, working memory and executive functions. We conducted a randomized 2 × 3 repeated measures (stimulation × time) study, randomly assigning 27 healthy volunteers to an active intermittent theta-burst stimulation or a sham stimulation group. Participants were assessed using a comprehensive neuropsychological battery before, immediately after, and 15 days after finishing the video game+TMS training. The training consisted of 10 sessions where participants played a 3D platform video game for 1.5 h. After each gaming session, TMS was applied over the right dorsolateral prefrontal cortex (DLPFC). All participants improved their video gaming performance, but we did not find a synergistic effect of stimulation and video game training. Neither had we found cognitive improvements related to the stimulation. We explored possible confounding variables such as age, gender, and early video gaming experience through linear regression. The early video gaming experience was related to improvements in working memory and inhibitory control. This result, although exploratory, highlights the influence of individual variables and previous experiences on brain plasticity.",2020,The early video gaming experience was related to improvements in working memory and inhibitory control.,['27 healthy volunteers to an'],"['TMS and video game training', 'Transcranial magnetic stimulation (TMS', 'active intermittent theta-burst stimulation or a sham stimulation group', 'Cognitive Enhancement  via  Neuromodulation and Video Games']","['TMS effectiveness', 'working memory and inhibitory control', 'video gaming performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",27.0,0.0240715,The early video gaming experience was related to improvements in working memory and inhibitory control.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Palaus', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marrón', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00235']
2109,32623182,"Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX).","BACKGROUND


Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination.
PATIENTS AND METHODS


We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status 0-2 to alternately receive gemcitabine + nab-paclitaxel for 2 months then FOLFIRI.3 for 2 months in arm A, or gemcitabine + nab-paclitaxel alone until progression in arm B. The primary objective was to increase the 6-month progression-free survival (PFS) rate from 40% (H 0 ) to 60% (H 1 ); using the binomial exact method, 124 patients were required. Analyses were carried out in preplanned modified intention-to-treat (mITT) and per-protocol (PP) populations.
RESULTS


Between November 2015 and November 2016, 127 patients were enrolled. Main grade III-IV toxicities (% in arm A/B) were: diarrhoea (12.5/1.7), neutropenia (46.9/31, including febrile neutropenia: 1.6/0), skin toxicity (6.3/13.8), and peripheral neuropathy (6.3/8.6). No toxic deaths occurred. The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm B. The primary end-point (6-month PFS rate) was 45.2% [one-sided 95% CI: 34.3-56.4] in arm A and 23.3% in arm B [one-sided 95% CI: 14.3-32.3] in the mITT population. In the PP population, median PFS and OS were 7.6 months and 6 months and 14.5 months and 12.2 months in arm A and B, respectively.
CONCLUSIONS


The FIRGEMAX strategy with gemcitabine + nab-paclitaxel alternating with FOLFIRI.3 every 2 months, appears feasible and effective, with manageable toxicities, in patients able to reach >2mo of treatment.
TRIAL REGISTRATION INFORMATION


EudraCT: 2014-004449-28: NCT: 0282701.",2020,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"['We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status\xa00-2 to alternately receive', 'metastatic pancreatic adenocarcinoma (mPA', 'patients with metastatic pancreatic adenocarcinoma', 'Between November 2015 and November 2016', '127 patients were enrolled']","['gemcitabine\xa0+\xa0nab-paclitaxel', 'Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3', 'gemcitabine\xa0+\xa0nab-paclitaxel standard first-line combination', 'gemcitabine\xa0+\xa0nab-paclitaxel alone until progression in arm B', 'gemcitabine', 'gemcitabine\xa0+\xa0nab-paclitaxel alternating with FOLFIRI.3']","['peripheral neuropathy', 'toxic deaths', 'neutropenia', 'diarrhoea', 'Main grade III-IV toxicities', 'median PFS and OS', 'skin toxicity', 'objective response rate', '6-month progression-free survival (PFS) rate']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",127.0,0.0595149,The objective response rate was 40.3% (95% confidence interval [CI]: 28.1-53.6) in arm A and 26.7% (95% CI: 16.1-39.7) in arm,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Pointet', 'Affiliation': 'Department of Hepato-gastroenterology, Georges Pompidou European Hospital, Paris, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Department of Hepato-gastroenterology, Saint Jean Hospital, Perpignan, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Biostatistics Department, Francophone Federation of Digestive Cancerology, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Bidaut', 'Initials': 'B', 'LastName': 'Wahiba', 'Affiliation': 'Department of Hepato-gastroenterology, European Hospital, Marseille, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Louafi', 'Affiliation': 'Department of Oncology, Sud Francilien Hospital Center, Corbeil-Essonnes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gratet', 'Affiliation': 'Oncology and Hematology ONCOSUD Unit, Clinic Pasteur, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Radiotherapy, Private Hospital Center, Saint-Grégoire, France.'}, {'ForeName': 'Hortense', 'Initials': 'H', 'LastName': 'Laharie', 'Affiliation': 'Department of Oncology and Radiotherapy, Clinic Tivoli, Bordeaux, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Bouhier Leporrier', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital, Caen, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thirot Bidault', 'Affiliation': 'Department of Hepato-gastroenterology, Private Hospital, Antony, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Texereau', 'Affiliation': 'Department of Hepato-gastroenterology, Layne Hospital, Mont-De-Marsan, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Coriat', 'Affiliation': 'Department of Hepato-gastroenterology, Cochin Hospital, APHP, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Department of Hepato-gastroenterology, Haut Lévêque Hospital, Pessac, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Gouttebel', 'Affiliation': 'Department of Oncology, Drôme Nord Hospital, Romans Sur Isère, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Department of Hepato-gastroenterology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepato-gastroenterology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-gastroenterology, University Hospital of Dijon, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Hepato-gastroenterology, Sorbonne Paris City, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.018']
2110,32623230,"Supplemental income program design: A cluster-randomized controlled trial to examine the health and wellbeing effects on older adults by gender, duration, and payment frequency.","BACKGROUND


We documented results from a cluster-randomized controlled trial we designed to supplement incomes in poor towns among adults 70 or older. We analyzed effects on health by gender, persistence over time, and variation by payment frequency.
METHODS


We compared supplemental income effects over an 18-month period for two towns in Yucatan, Mexico: Valladolid, where eligible individuals received a monthly income supplement over the entire analysis period, and Motul, a demographically matched control town, where eligible individuals received a bimonthly income supplement over the last 12 months of the analysis period. While differing in frequency of payment, supplements provided similar levels of income. We conducted three surveys of recipients: (1) at baseline, (2) six months after baseline, and (3) 18 months after baseline.
RESULTS


The primary outcomes we examined were peak expiratory flow, hemoglobin level, and verbal recall. The secondary outcomes were health care use and food availability. We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting. Bimonthly income supplements had smaller health benefits.
CONCLUSIONS


Older people in the developing world who lack social security benefits and health care may benefit most from monthly income programs. The greater payment frequency of monthly programs may influence how household resources are allocated. Supplemental income programs are common in low- and middle-income countries; hence, our results have implications for program design in many nations.",2020,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","['supplement incomes in poor towns among adults 70 or older', 'older adults by gender, duration, and payment frequency']",[],"['health care use and food availability', 'peak expiratory flow, hemoglobin level, and verbal recall', 'smaller health benefits']","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",,0.190785,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aguila', 'Affiliation': 'Sol Price School of Public Policy, USC, 650 Childs Way, RGL Hall, Room 226, Los Angeles, CA, 90089, USA. Electronic address: eaguilav@usc.edu.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Smith', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113139']
2111,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
2112,32623361,Immediate effects of valgus bracing on knee joint moments during walking in knee-healthy individuals: Potential modifying effects of body height.,"BACKGROUND


The goal of valgus knee brace treatment is to reduce medial knee joint loading during walking, often indicated by external knee adduction moment (KAM) measures. However, existing healthy-subjects studies have been equivocal in demonstrating KAM reduction with valgus knee bracing.
RESEARCH QUESTION


What are the immediate effects of valgus bracing at different tension levels on KAM during walking at a controlled speed and does body height modify the brace-KAM associations?
METHODS


Data from 32 knee-healthy participants were analysed in this randomized crossover trial. Participants performed walking trials at controlled speed (1.3 ± 0.065 m/s) both with and without an Ossür Unloader One® brace. During the bracing condition, valgus tension was incrementally increased, from zero tension to normal tension and to maximum tolerable tension.
RESULTS


Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels. Valgus bracing, overall, did not significantly reduce the various KAM measures. However, brace use at maximal tension was associated with a 0.04Nm/kg (9.2 %) increase in first peak KAM amongst participants with a body height of 1.75 m and a 0.03Nm/kg (7.6 %) decrease in first peak KAM amongst participants with a body height of 1.55 m.
SIGNIFICANCE


Valgus bracing did not reduce the various KAM measures during walking; however, body height may play a moderating role. Given knee brace sizes vary more in circumference than length, this result may be due to the ratio between effective moment arm length relative to limb length. A deeper understanding of the potential neuro-biomechanical effects of valgus knee bracing and how these effects are potentially modified by body height may be critical to the design of effective knee braces.",2020,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"['Data from 32 knee-healthy participants', 'knee-healthy individuals']",['valgus bracing'],"['gait velocity', 'various KAM measures', 'knee joint moments', 'knee flexion at heel-strike']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.0313931,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"[{'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Pua', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: pua.yong.hao@sgh.com.sg.'}, {'ForeName': 'Hong-Han', 'Initials': 'HH', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: tan.hong.han@sgh.com.sg.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Mentiplay', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Victoria, Australia. Electronic address: b.mentiplay@latrobe.edu.au.'}, {'ForeName': 'Leon Zhi-Xia', 'Initials': 'LZ', 'LastName': 'Lim', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: leonlimzx@hotmail.com.'}, {'ForeName': 'Asher Chi-Weng', 'Initials': 'AC', 'LastName': 'Tham', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: ashertham@hotmail.com.'}, {'ForeName': 'Joshua Jia-En', 'Initials': 'JJ', 'LastName': 'Quek', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: Quek.joshua@gmail.com.'}, {'ForeName': 'Ee-Lin', 'Initials': 'EL', 'LastName': 'Woon', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: woon.ee.lin@sgh.com.sg.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Yeh', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: tingting.yeh@singaporetech.edu.sg.'}, {'ForeName': 'Celia Ia-Choo', 'Initials': 'CI', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore; SingHealth Group Allied Health, Singapore. Electronic address: celia.tan.i.c@singhealth.com.sg.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hunt', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. Electronic address: michael.hunt@ubc.ca.'}, {'ForeName': 'Ross Allan', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'Research Health Institute, University of the Sunshine Coast, Sunshine Coast, Australia. Electronic address: rclark@usc.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.06.025']
2113,32623367,"A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial.","BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children.
OBJECTIVE


This study's aim was to provide an accessible platform, NeW-I-which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform-that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses.
METHODS


The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed.
RESULTS


Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing.
CONCLUSIONS


NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17561.",2020,"BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses.","['Parents of Children With Chronic Life-Threatening Illnesses', 'parents of children with chronic life-threatening illnesses', 'enroll 36 participants in each group (N=72']",['Narrative E-Writing Intervention'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.175167,"BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses.","[{'ForeName': 'Andy Hau Yan', 'Initials': 'AHY', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Oindrila', 'Initials': 'O', 'LastName': 'Dutta', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Tan-Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Toh Hsiang Benny', 'Initials': 'THB', 'LastName': 'Tan', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Casuarine Xinyi', 'Initials': 'CX', 'LastName': 'Low', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Sashikumar', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'Club Rainbow, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Ringo Moon-Ho', 'Initials': 'RM', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Chun Yan', 'Initials': 'CY', 'LastName': 'Miao', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}]",JMIR research protocols,['10.2196/17561']
2114,32623368,Effectiveness of Using Mental Health Mobile Apps as Digital Antidepressants for Reducing Anxiety and Depression: Protocol for a Multiple Baseline Across-Individuals Design.,"BACKGROUND


The use of mental health mobile apps to treat anxiety and depression is widespread and growing. Several reviews have found that most of these apps do not have published evidence for their effectiveness, and existing research has primarily been undertaken by individuals and institutions that have an association with the app being tested. Another reason for the lack of research is that the execution of the traditional randomized controlled trial is time prohibitive in this profit-driven industry. Consequently, there have been calls for different methodologies to be considered. One such methodology is the single-case design, of which, to the best of our knowledge, no peer-reviewed published example with mental health apps for anxiety and/or depression could be located.
OBJECTIVE


The aim of this study is to examine the effectiveness of 5 apps (Destressify, MoodMission, Smiling Mind, MindShift, and SuperBetter) in reducing symptoms of anxiety and/or depression. These apps were selected because they are publicly available, free to download, and have published evidence of efficacy.
METHODS


A multiple baseline across-individuals design will be employed. A total of 50 participants will be recruited (10 for each app) who will provide baseline data for 20 days. The sequential introduction of an intervention phase will commence once baseline readings have indicated stability in the measures of participants' mental health and will proceed for 10 weeks. Postintervention measurements will continue for a further 20 days. Participants will be required to provide daily subjective units of distress (SUDS) ratings via SMS text messages and will complete other measures at 5 different time points, including at 6-month follow-up. SUDS data will be examined via a time series analysis across the experimental phases. Individual analyses of outcome measures will be conducted to detect clinically significant changes in symptoms using the statistical approach proposed by Jacobson and Truax. Participants will rate their app on several domains at the end of the intervention.
RESULTS


Participant recruitment commenced in January 2020. The postintervention phase will be completed by June 2020. Data analysis will commence after this. A write-up for publication is expected to be completed after the follow-up phase is finalized in January 2021.
CONCLUSIONS


If the apps prove to be effective as hypothesized, this will provide collateral evidence of their efficacy. It could also provide the benefits of (1) improved access to mental health services for people in rural areas, lower socioeconomic groups, and children and adolescents and (2) improved capacity to enhance face-to-face therapy through digital homework tasks that can be shared instantly with a therapist. It is also anticipated that this methodology could be used for other mental health apps to bolster the independent evidence base for this mode of treatment.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/17159.",2020,Individual analyses of outcome measures will be conducted to detect clinically significant changes in symptoms using the statistical approach proposed by Jacobson and Truax.,['50 participants will be recruited (10 for each app) who will provide baseline data for 20 days'],"['Mental Health Mobile Apps', '5 apps (Destressify, MoodMission, Smiling Mind, MindShift, and SuperBetter']",[],"[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}]",[],50.0,0.167334,Individual analyses of outcome measures will be conducted to detect clinically significant changes in symptoms using the statistical approach proposed by Jacobson and Truax.,"[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Marshall', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of New England, Armidale, Australia.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Dunstan', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of New England, Armidale, Australia.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Bartik', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of New England, Armidale, Australia.'}]",JMIR research protocols,['10.2196/17159']
2115,32623487,A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab.,"This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated.
INTRODUCTION


Follow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment.
METHODS


This phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0-24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72.
RESULTS


A total of 141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48-72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: - 0.8% from months 48-72; 12.8% from months 0-72). Similar patterns were observed for proximal femur BMD in both groups. With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed.
CONCLUSION


A zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment.",2020,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","['141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group', 'postmenopausal women with low bone mass', 'enrolled postmenopausal women with low bone mineral density (BMD', 'At month 48, subjects who had received active treatment for 48\xa0months']","['zoledronate 5\xa0mg IV', 'romosozumab treatment', 'various romosozumab doses or placebo', 'denosumab', 'zoledronate', 'placebo']","['bone mineral density', 'proximal femur BMD', 'P1NP and β-CTX', 'β-CTX levels', 'tolerated', 'BMD gains', 'efficacy and safety', 'Efficacy (BMD, P1NP, and β-CTX) and safety', 'LS BMD', 'lumbar spine (LS) BMD']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",141.0,0.0281302,"Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR 97210, USA. mmcclung.ooc@gmail.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Bethesda Health Research Center, Bethesda, MD, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'Laval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'University of Liège, Liège, Belgium.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Meisner', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05502-0']
2116,32623510,"Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial.","PURPOSE


To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).
METHODS


We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.
RESULTS


A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.
CONCLUSION


90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.
RETROSPECTIVELY REGISTERED


ChiCTR2000030924, 2020/3/17.",2020,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","['A total of 354 and 351 patients were included in BCQB group and in placebo group', 'persistent allergic rhinitis', 'patients with PAR', '720 patients from 15 hospitals across China and randomly assigned them into', 'patients with persistent allergic rhinitis (PAR']","['BCQB', 'VAS', 'Bencycloquidium bromide nasal spray', 'BCQB group or placebo', 'bencycloquidium bromide nasal spray (BCQB', 'placebo']","['change ratio from baseline of VAS for rhinorrhea', 'Adverse events', 'VAS for rhinorrhea', 'incidence of adverse reaction', 'Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",720.0,0.566384,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","[{'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shixi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, 610072, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Southwest Hospital, Army Medical University, 30 Gaotan Yan St, Chongqing, 400038, People's Republic of China.""}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Daping Hospital, Army Medical University, Chongqing, 400042, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Otolaryngology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, People's Republic of China.""}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Otorhinolaryngology, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Xuping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Hunan Provincial People's Hospital, Changsha, 410005, People's Republic of China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': ""Department of Otolaryngology, Qingdao Municipal Hospital, Qingdao, Shandong, 266011, People's Republic of China.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Dong', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Shanghai General Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, People's Republic of China.""}, {'ForeName': 'Yongwang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The First People's Hospital, Yangzhou, 225001, People's Republic of China.""}, {'ForeName': 'Guolin', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, 410013, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Health, Statistics, Faculty of Medical Service, Second Military Medical University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Yingu Pharmaceutical Co., Ltd, Beijing, 100190, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China. mjmelinda@163.com.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06183-5']
2117,32623524,Efficacy of ozonated water mouthwash on early plaque formation and gingival inflammation: a randomized controlled crossover clinical trial.,"OBJECTIVES


To evaluate the effect of ozonated water in early plaque formation and gingival inflammation.
MATERIALS AND METHODS


This was a randomized, controlled, double-blind, crossover clinical trial with two experimental periods of 96 h each, with 10 washout days between them. The sample consisted of 42 dental students divided into Test Group, mouthwash of ozonated water, and Control Group, bidistilled water mouthwash. The participants were instructed not to perform oral hygiene and used the assigned mouthwash under supervision once a day. For the investigation of the initial subgingival biofilm formation, the Plaque Free Zone Index was used at 24, 48, 72, and 96 h. The volume of gingival crevicular fluid, a questionnaire for taste perception assessment, and analysis of the adverse effects were also carried out.
RESULTS


The percentage of conversion scores 0 and 1 to 2 of PFZ Index, the main outcome, for all dental surfaces showed no statistical difference between Test and Control groups, with 19.07 and 19.79, respectively. Also, there was not a significant difference in the score frequencies at each time point. Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups. Test group had worse evaluation of taste perception and more adverse effects.
CONCLUSIONS


Ozonated water seems not to affect the formation of supra and subgingival biofilms, as well as gingival inflammation.
CLINICAL SIGNIFICANCE


Mouthwash with ozonated water once a day do not affect supra and subgingival biofilm formation.",2020,Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups.,['42 dental students divided into'],"['Test Group, mouthwash of ozonated water, and Control Group, bidistilled water mouthwash', 'GCF', 'ozonated water mouthwash']","['formation of supra and subgingival biofilms', 'score frequencies', 'taste perception and more adverse effects', 'early plaque formation and gingival inflammation', 'percentage of conversion scores', 'supra and subgingival biofilm formation']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3693482', 'cui_str': 'Giant cell fibroblastoma'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",42.0,0.168695,Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups.,"[{'ForeName': 'Alessandra Cardoso', 'Initials': 'AC', 'LastName': 'Nicolini', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. alessandrac_nicolini@hotmail.com.'}, {'ForeName': 'Isadora Dos Santos', 'Initials': 'IDS', 'LastName': 'Rotta', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Gerson Pedro José', 'Initials': 'GPJ', 'LastName': 'Langa', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Stephanie Anagnostopoulos', 'Initials': 'SA', 'LastName': 'Friedrich', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'David Alejandro', 'Initials': 'DA', 'LastName': 'Arroyo-Bonilla', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcius Comparsi', 'Initials': 'MC', 'LastName': 'Wagner', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Weidlich', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cassiano Kuchenbecker', 'Initials': 'CK', 'LastName': 'Rösing', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Cavagni', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03441-y']
2118,32623539,Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays.,"A single-blind randomised control trial investigated the effectiveness of the Learn, Engage and Play (LEaP) playgroup. Seventy-one children with developmental delay were randomly allocated to an 8-week LEaP playgroup or control group and followed up at 12 and 28 weeks. On the primary outcome measure, LEaP demonstrated significant within group changes at 28 weeks (parenting distress p = 0.018) but no between group changes. On secondary outcome measures, at 12 weeks LEaP produced significantly better outcomes than control in goal achievement (performance p = 0.022; function p = 0.008) and family-support (p = 0.024), with LEaP continuing to demonstrate significantly better goal achievement (child performance p = 0.042; function p = 0.012) at 28 weeks. Findings indicate LEaP may assist in improving family-support and goal achievement outcomes for children with developmental delays.",2020,"On the primary outcome measure, LEaP demonstrated significant within group changes at 28 weeks (parenting distress p = 0.018) but no between group changes.","['Seventy-one children with developmental delay', 'Children with Developmental Delays', 'children with developmental delays']","['Therapeutic Playgroup', 'LEaP playgroup or control', 'Learn, Engage and Play (LEaP) playgroup']",['goal achievement'],"[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543438', 'cui_str': 'Playgroup'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",71.0,0.118797,"On the primary outcome measure, LEaP demonstrated significant within group changes at 28 weeks (parenting distress p = 0.018) but no between group changes.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Armstrong', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia. Jodie.Armstrong@health.wa.gov.au.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Girdler', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'Child Development Service, Child and Adolescent Health Service, Perth, WA, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mizen', 'Affiliation': 'Child Development Service, Child and Adolescent Health Service, Perth, WA, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Child Health Research, Child and Adolescent Health Service, Perth, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wray', 'Affiliation': 'Child Development Service, Child and Adolescent Health Service, Perth, WA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04580-7']
2119,32623646,"Assessment of patient satisfaction, functionality, and quality of life after ultrasound-guided knee intervention: a prospective study.","OBJECTIVES


The use of ultrasound (US) guidance for the injection and aspiration of joints has improved accuracy. The aim of this study was to determine if differences exist in the level of patient satisfaction, functionality, and the quality of life in adult patients receiving US-guided (USG) versus landmark-guided (LMG) knee procedures.
METHODS


This prospective, randomized study enrolled 41 patients undergoing knee procedures to USG or LMG groups. visual analogue scale (VAS) for pain, knee injury and osteoarthritis outcome score (KOOS), and patient satisfaction score on a 5-point Likert scale were measured pre-procedure, immediate (< 30 min) and late (4-6 weeks) post-procedure.
RESULTS


Thirty-seven patients were included in the final analysis after exclusion of 4 dropouts (18 in LMG arm, 19 in USG arm). Compared with LMG group, patients in the USG group had significantly better improvement in pain immediately (VAS 1.63 ± 1.6 (95% CI 0.91, 2.35) vs 4.05 ± 2.5 (95% CI 2.90, 4.62), p = 0.001) and later post-procedure (VAS 2.68 ± 2.0 (95% CI 1.78, 3.58) vs 6.38 ± 3.8 (95% CI 4.62, 8.14) p = 0.004) and satisfaction scores immediately (4.89 ± 0.3 (95% CI 4.76, 5.02) vs 4.11 ± 1.0 (95% CI 3.65, 4.57), p = 0.002) as well as delayed post-procedure (4.52 ± 0.9 (95% CI 4.12, 4.92) vs 3.38 ± 1.6 (95% CI 2.64, 4.12), p = 0.028).
CONCLUSION


USG knee procedures were associated with higher patient satisfaction, both immediately after the procedure and after 4-6 weeks compared with LMG knee procedures. Key Points •This prospective study is the first one to look at patient satisfaction as an outcome measure after intra-articular steroids knee injections. •USG (US-guided) knee procedures were associated with higher patient satisfaction compared with LMG (landmark-guided) knee procedures. •USG knee procedures resulted in greater improvement in symptoms, pain, and quality of life scales after 4-6 weeks compared with LMG knee procedures.",2020,(US-guided) knee procedures were associated with higher patient satisfaction compared with LMG (landmark-guided) knee procedures.,"['adult patients receiving', '41 patients undergoing knee procedures to USG or LMG groups', 'Thirty-seven patients were included in the final analysis after exclusion of 4 dropouts (18 in LMG arm, 19 in USG arm']","['•USG', 'US-guided (USG) versus landmark-guided (LMG) knee procedures', 'LMG', 'ultrasound (US) guidance', 'ultrasound-guided knee intervention']","['quality of life', 'symptoms, pain, and quality of life scales', 'patient satisfaction, functionality, and quality of life', 'satisfaction scores', 'patient satisfaction', 'visual analogue scale (VAS) for pain, knee injury and osteoarthritis outcome score (KOOS), and patient satisfaction score on a 5-point Likert scale', 'pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292892', 'cui_str': 'Procedure on knee'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1292892', 'cui_str': 'Procedure on knee'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",41.0,0.0909335,(US-guided) knee procedures were associated with higher patient satisfaction compared with LMG (landmark-guided) knee procedures.,"[{'ForeName': 'Tejas', 'Initials': 'T', 'LastName': 'Sheth', 'Affiliation': 'Bone and Joint Institute, Hartford Hospital, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Oscar Mena', 'Initials': 'OM', 'LastName': 'Miranda', 'Affiliation': 'Internal Medicine, Albert Einstein College of Medicine/Jacobi Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Jacobi Medical Center, Albert Einstein College of Medicine, 1400 Pelham Parkway South, Jacobi Medical Center, Building 1, #3N-06, Rheumatology Division, Bronx, NY, 10461, USA. Beverly.johnson@nychhc.org.'}]",Clinical rheumatology,['10.1007/s10067-020-05254-6']
2120,32623650,Intra-articular injection of etanercept versus glucocorticoids in rheumatoid arthritis patients.,"OBJECTIVES


This study was conducted to assess the safety and efficacy of intra-articular injection of etanercept and compare it with corticosteroid injection in rheumatoid arthritis (RA) patients.
METHODS


Fifty patients with RA who suffered from activity in one joint were randomized into two groups, received an intra-articular injection of either etanercept or corticosteroid guided by musculoskeletal ultrasound. All patients were assessed for disease activity by disease activity score (DAS28), functional assessment using the Modified Health Assessment Questionnaire (MHAQ), and laboratory investigations (erythrocyte sedimentation rate and C-reactive protein). Joints affected were evaluated for pain by visual analog scale (VAS), tenderness, and swelling scores and by ultrasound for estimation of synovial hypertrophy, synovial effusion, and power Doppler. Follow-up of the patients was done at weeks 1, 4, and 12 after injection by clinical assessment and ultrasound.
RESULTS


There was a significant improvement of joint pain assessed by VAS, tenderness, and swelling scores in the etanercept group at week 1 and week 4 follow-up periods but there were insignificant changes at week 12. There was a significant decrease in synovial effusion at week 1 and week 4 and in power Doppler at week 1 but no significant change was noticed in synovial hypertrophy during the follow-up periods. In comparison of the two groups, etanercept has shown better results on joint scores at week 1; however, glucocorticoid had more sustained effects. No major or life-threatening side effects were noticed following intra-articular injection of etanercept.
CONCLUSION


Intra-articular injection of etanercept is a safe and promising option; with comparable results to intra-articular injection of corticosteroid; however, its rapid absorption from the synovium may necessitate frequent injections. Key Points • Persistent inflammatory mono-arthritis is a common clinical problem that is often difficult to treat; it is a debilitating and destructive condition. • Intra-articular injection of TNF inhibitors is an encouraging treatment modality in managing refractory mono-arthritis in rheumatoid arthritis.",2020,There was a significant decrease in synovial effusion at week 1 and week 4 and in power Doppler at week 1 but no significant change was noticed in synovial hypertrophy during the follow-up periods.,"['Fifty patients with RA who suffered from activity in one joint', 'rheumatoid arthritis patients', 'rheumatoid arthritis (RA) patients']","['etanercept or corticosteroid guided by musculoskeletal ultrasound', 'etanercept', 'corticosteroid injection', 'TNF inhibitors', 'etanercept versus glucocorticoids']","['synovial effusion', 'synovial hypertrophy', 'joint scores', 'disease activity by disease activity score (DAS28), functional assessment using the Modified Health Assessment Questionnaire (MHAQ), and laboratory investigations (erythrocyte sedimentation rate and C-reactive protein', 'No major or life-threatening side effects', 'safety and efficacy', 'pain by visual analog scale (VAS), tenderness, and swelling scores and by ultrasound for estimation of synovial hypertrophy, synovial effusion, and power Doppler', 'joint pain assessed by VAS, tenderness, and swelling scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1253936', 'cui_str': 'Effusion of joint'}, {'cui': 'C0410574', 'cui_str': 'Synovial hypertrophy'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0451209', 'cui_str': 'Modified health assessment questionnaire'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}]",50.0,0.0506558,There was a significant decrease in synovial effusion at week 1 and week 4 and in power Doppler at week 1 but no significant change was noticed in synovial hypertrophy during the follow-up periods.,"[{'ForeName': 'Rehab Mahmoud', 'Initials': 'RM', 'LastName': 'Salem', 'Affiliation': 'Physical Medicine, Rheumatology, and Rehabilitation Department, Faculty of Medicine, Tanta University, Geish Street, Tanta, Gharbia, Egypt.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'El-Deeb', 'Affiliation': 'Physical Medicine, Rheumatology, and Rehabilitation Department, Faculty of Medicine, Tanta University, Geish Street, Tanta, Gharbia, Egypt.'}, {'ForeName': 'Mervat', 'Initials': 'M', 'LastName': 'Elsergany', 'Affiliation': 'Physical Medicine, Rheumatology, and Rehabilitation Department, Faculty of Medicine, Tanta University, Geish Street, Tanta, Gharbia, Egypt.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Elsaadany', 'Affiliation': 'Physical Medicine, Rheumatology, and Rehabilitation Department, Faculty of Medicine, Tanta University, Geish Street, Tanta, Gharbia, Egypt.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'El-Khouly', 'Affiliation': 'Physical Medicine, Rheumatology, and Rehabilitation Department, Faculty of Medicine, Tanta University, Geish Street, Tanta, Gharbia, Egypt. radwa.elkhouli@med.tanta.edu.eg.'}]",Clinical rheumatology,['10.1007/s10067-020-05235-9']
2121,32623701,"Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome: A Randomized, Placebo-Controlled Trial.","OBJECTIVE


To evaluate the efficacy and safety of administration of the formulated Persian herbal syrup on improving the symptoms of patients with constipation-predominant irritable bowel syndrome (IBS-C).
METHODS


This study was conducted in 70 patients with IBS-C, who were recruited from 3 medical centers in Mashhad, Iran, from November 2017 to August 2018. Seventy patients were randomly assigned to 2 groups including treatment and placebo groups by block randomization, 35 cases in each group. Patients in the treatment group received 15 mL of anti-IBS syrup, thrice daily for 6 weeks and followed up for 4 weeks. Placebo syrup was also prepared through similar instruction, BP syrup without plant extract was used. Primary outcome induding IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS) were completed and evaluated at weeks 6 and 10, respectively. Safety indices were collected at the end of the treatment and Common Terminology Criteria for Adverse Events v4.0 (CTCAE) was used to evaluate the adverse events.
RESULTS


The response to treatment was 84.4% (27/32) in the treatment group and 46.4% (13/28) in the placebo group, respectively (P= 0.002). Compared with pre-treatment, a significant decrease was found on the IBS-SSS and BSFS scores after 6-week intervention in both groups (P<0.001). Moreover, IBS-SSS and BSFS scores in the treatment group were lower than the placebo group after the intervention (P=0.041). There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05). Side effects reported in the treatment group included 2 cases of headache during the first week of the onset of the treatment, 1 case of drowsiness, 1 case of increase in menstrual bleeding, which did not result in discontinuation of the treatment. In the placebo group, 1 case of exacerbation of the disease was reported.
CONCLUSIONS


Anti-IBS syrup significantly reduced the severity of IBS symptoms compared to placebo. However, there was a need for further investigation regarding the anxiety and depression scores. (Registration No. IRCT2017061034446N1).",2020,There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05).,"['Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome', 'Seventy patients', '70 patients with IBS-C, who were recruited from 3 medical centers in Mashhad, Iran, from November 2017 to August 2018', 'patients with constipation-predominant irritable bowel syndrome (IBS-C']","['formulated Persian herbal syrup', 'Placebo', '15 mL of anti-IBS syrup', 'placebo']","['Safety indices', 'headache', 'severity of IBS symptoms', 'IBS-SSS and BSFS scores', 'anxiety and depression scores', 'menstrual bleeding', 'IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS', 'Side effects', 'efficacy and safety']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1868889', 'cui_str': 'Irritable bowel syndrome characterized by constipation'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",70.0,0.106066,There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05).,"[{'ForeName': 'Hamide Khorram', 'Initials': 'HK', 'LastName': 'Pazhouh', 'Affiliation': 'Persian Medicine, Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran.'}, {'ForeName': 'Seyyd Musa', 'Initials': 'SM', 'LastName': 'Al-Reza Hosseini', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, 91776699199, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghipour', 'Affiliation': 'Faculty of Health, Mashhad University of Medical Sciences, Mashhad, 9137673119, Iran.'}, {'ForeName': 'Shokouhsadat', 'Initials': 'S', 'LastName': 'Hamedi', 'Affiliation': 'Department of Persian Pharmacy, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Noras', 'Affiliation': 'Persian Traditional Medicine, Faculty of Persian Traditional and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran. NorasMR@mums.ac.ir.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3267-4']
2122,32623977,Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2.,"BACKGROUND AND PURPOSE


Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)-lowering therapy.
METHODS


Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110-139 mm Hg) or standard (140-179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored.
RESULTS


In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02-1.37,  P =0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men ( P  for interaction=0.11), with inconclusive Gail-Simmon test ( P =0.16).
CONCLUSIONS


Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.",2020,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","['Eligible intracerebral hemorrhage subjects', '380 women and 620 men were included', 'Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men']","['intensive BP-lowering therapy', 'Hg) BP-lowering therapy']","['Hematoma expansion', 'risk of death or disability', 'relative risk of death or disability', 'Relative risk of death or disability corresponding to the modified Rankin Scale score']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",380.0,0.38882,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., M.K., S.Y., K.M., K.T.).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., H.Y.).'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., M.K., S.Y., K.M., K.T.).'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN (A.I.Q.).'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., M.K., S.Y., K.M., K.T.).'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan. (S. Okazaki).'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., M.K., S.Y., K.M., K.T.).'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Fukuoka, Japan (Y.O.).'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki, Japan (T.U.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okuda', 'Affiliation': 'Department of Neurology, National Hospital Organization Nagoya Medical Center, Japan (S. Okuda).'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Nakahara', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. (M.F.-D., M.K., S.Y., K.M., K.T.).'}]",Stroke,['10.1161/STROKEAHA.120.029770']
2123,32624004,Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial.,"BACKGROUND


Children with cancer experience impaired cardiorespiratory fitness and physical function during and after treatment restricting their possibilities to engage in social activities including sport, leisure activities, and school. The objectives were to determine the effects of classmate-supported, controlled, supervised, in-hospital, physical activity program to preserve cardiorespiratory fitness and physical function from time of diagnosis in children with cancer.
METHODS


National non-randomized controlled trial including schoolchildren aged 6-18 years at diagnosis treated with chemo-/radiotherapy. We included 120 of 128 eligible patients (94%) in the intervention group (62.5% boys, 11.2 ± 3.1 years) from East Denmark and 58 patients in the control group (57% boys, 11.0 ± 3.2 years) from West Denmark. Eight children from the control group withdrew from participation. The groups were comparable in anthropometrics and cancer diagnoses (p > 0.05). The intervention consisted of (i) supervised in-hospital physical activity from diagnosis and throughout intensive treatment, (ii) 90-min general educational session on cancer and therapy in the child's school class, and (iii) selection of two classmates as ambassadors who took turns to support the child's physical training during the daytime. The primary outcome was cardiorespiratory fitness (VO 2 peak, mL/min/kg) at 6 months after diagnosis (sex, age, diagnosis adjusted). Secondary outcomes were sit-to-stand, timed-up-and-go, handgrip strength, and balance test scores.
RESULTS


Ambassadors were identified for all, and 2542 individual and 621 group training sessions were held. VO 2 peak deteriorated over time in the control group (- 0.17 [95% CI - 0.32 to - 0.02] per week, p = 0.02), but not in the intervention group (p = 0.14). At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
CONCLUSIONS


Peer-supported, supervised, in-hospital, physical activity is safe and feasible in children with cancer during treatment. Further, the results suggest that the intervention might mitigate impairments in cardiorespiratory fitness during treatment in children with cancer.
TRIAL REGISTRATION


The study was prospectively registered on the 11 January 2013. Clinicaltrial.gov NCT01772849 and NCT01772862 .",2020,"At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
","['11 January 2013', 'children with cancer', 'children with cancer during treatment', 'Children with cancer experience', '120 of 128 eligible patients (94%) in the intervention group (62.5% boys, 11.2\u2009±\u20093.1\u2009years) from East Denmark and 58 patients in the control group (57% boys, 11.0\u2009±\u20093.2\u2009years) from West Denmark', 'schoolchildren aged 6-18\u2009years at diagnosis treated with']","[""intervention consisted of (i) supervised in-hospital physical activity from diagnosis and throughout intensive treatment, (ii) 90-min general educational session on cancer and therapy in the child's school class, and (iii) selection of two classmates as ambassadors who took turns to support the child's physical training"", 'physical activity program', 'chemo-/radiotherapy']","['physical function', 'VO 2 peak', 'cardiorespiratory fitness (VO 2 peak, mL/min/kg', 'VO 2 peak deteriorated over time', 'sit-to-stand, timed-up-and-go, handgrip strength, and balance test scores', 'anthropometrics and cancer diagnoses', 'cardiorespiratory fitness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",8.0,0.0404822,"At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
","[{'ForeName': 'Martin Kaj Fridh', 'Initials': 'MKF', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Frank', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Center for Inflammation and Metabolism/Center for Physical Activity (CIM/CFAS), University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'Thomas Leth', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Department of Sports Medicine, Norwegian School for Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peder Skov', 'Initials': 'PS', 'LastName': 'Wehner', 'Affiliation': ""Department of Pediatric Hematology and Oncology, H.C. Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hasle', 'Affiliation': 'Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lis Ørgaard', 'Initials': 'LØ', 'LastName': 'Adamsen', 'Affiliation': 'Faculty of Health Science, Department of Public Health, Institute for Clinical Medicine, The University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Hanne Bækgaard', 'Initials': 'HB', 'LastName': 'Larsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark. hanne.baekgaard.larsen@regionh.dk.'}]",BMC medicine,['10.1186/s12916-020-01634-6']
2124,32624013,Preventing depression using a smartphone app: a randomized controlled trial.,"BACKGROUND


There is evidence that depression can be prevented; however, traditional approaches face significant scalability issues. Digital technologies provide a potential solution, although this has not been adequately tested. The aim of this study was to evaluate the effectiveness of a new smartphone app designed to reduce depression symptoms and subsequent incident depression amongst a large group of Australian workers.
METHODS


A randomized controlled trial was conducted with follow-up assessments at 5 weeks and 3 and 12 months post-baseline. Participants were employed Australians reporting no clinically significant depression. The intervention group (N = 1128) was allocated to use HeadGear, a smartphone app which included a 30-day behavioural activation and mindfulness intervention. The attention-control group (N = 1143) used an app which included a 30-day mood monitoring component. The primary outcome was the level of depressive symptomatology (PHQ-9) at 3-month follow-up. Analyses were conducted within an intention-to-treat framework using mixed modelling.
RESULTS


Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031). Prevalence of depression over the 12-month period was 8.0% and 3.5% for controls and HeadGear recipients, respectively, with odds of depression caseness amongst the intervention group of 0.43 (p = 0.001, 95% CI 0.26-0.70).
CONCLUSIONS


This trial demonstrates that a smartphone app can reduce depression symptoms and potentially prevent incident depression caseness and such interventions may have a role in improving working population mental health. Some caution in interpretation is needed regarding the clinical significance due to small effect size and trial attrition.Trial Registration Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au/) ACTRN12617000548336.",2020,"Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031).",['large group of Australian workers'],['smartphone app which included a 30-day behavioural activation and mindfulness intervention'],"['level of depressive symptomatology (PHQ-9', 'Prevalence of depression', 'depression symptoms', 'depressive symptoms']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.350688,"Those assigned to the HeadGear arm had fewer depressive symptoms over the course of the trial compared to those assigned to the control (F3,734.7 = 2.98, p = 0.031).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Central Clinical School, Brain and Mind Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Calvo', 'Affiliation': 'School of Electrical and Information Engineering, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Milne', 'Affiliation': 'School of Systems Management and Leadership, Faculty of Engineering and IT, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Central Clinical School, Brain and Mind Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Gayed', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Peters', 'Affiliation': 'School of Electrical and Information Engineering, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291720002081']
2125,32624182,Potentiation by sevoflurane of rocuronium-induced neuromuscular block is greater in older than younger adult patients: a randomised controlled trial.,,2020,,['older than younger adult patients'],"['rocuronium-induced neuromuscular block', 'sevoflurane']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",[],,0.594978,,"[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Takagi', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kitajima', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Matsui', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Tokyo, Japan. Electronic address: suzuki.takahiro@nihon-u.ac.jp.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.047']
2126,32624208,Operative treatment of 2-part surgical neck type fractures of the proximal humerus in the elderly: Cement augmented locking plate PHILOS™ vs. proximal humerus nail multiloc®.,"INTRODUCTION


The purpose of this prospective randomized controlled clinical trial was to compare locked plating with intramedullary nailing in the treatment of displaced 2-part surgical neck type proximal humeral fractures in elderly patients.
PATIENTS AND METHODS


Patients ≥60 years of age with a displaced 2-part surgical neck type fracture of the proximal humerus were surgically treated and randomized for either augmented locking plate fixation Group LP or multiplanar intramedullary nailing Group IN. The primary outcome parameter was the Disabilities of the Shoulder, Arm and Hand (DASH) Score after 24 months. Secondary outcome parameters were the age- and gender adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score (ASES), the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36) after 6 weeks, 3 months, 6 months, 12 and 24 months. Further parameters included the quality of fracture reduction as well as complications and revision surgeries. 60 patients with a mean age of 75±9.8 were included and longitudinally followed over 24 months (follow-up rate: 83.3%).
RESULTS


The mean DASH-Scores at 24 months was 32.6 ± 9.7 points in Group LP versus 37.8 ± 8.3 points in Group IN (p = 0.04). The mean Constant Murley Score at 24 months follow-up was 76.2 ± 7.7 points in Group LP compared to 72 ± 9.1 points in Group IN (p = 0.08). The ASES at 24 months follow-up was 75.1 ± 9 points in Group LP versus to 73.5 ± 8.9 in Group IN (p = 0.51). The OSS at 24 months was 43.7 ± 8.1 in Group LP compared to 38.2 ± 10 in Group IN (p = 0.03). The SF-36 at 24 months was 74.7 ± 12.5 in Group LP versus to 70.9 ± 12.8 in Group IN (p = 0.29). Screw cutting out was observed in n = 2 (6,7%) cases of Group LP, and in none of Group IN (p = 0.49). Revision surgery was necessary in n = 2 (6.7%) cases of Group LP and in two cases of Group IN (6.7%, p = 1).
CONCLUSION


Functional outcomes are similar at 2-years follow-up in locked plating with screw tip augmentation compared to intramedullary nailing. Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.",2020,"Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.","['60 patients with a mean age of 75±9.8 were included and longitudinally followed over 24 months (follow-up rate: 83.3', '2-part surgical neck type fractures of the proximal humerus in the elderly', 'Patients ≥60 years of age with a displaced 2-part surgical neck type fracture of the proximal humerus were surgically treated and randomized for either', 'displaced 2-part surgical neck type proximal humeral fractures in elderly patients']","['locked plating with intramedullary nailing', 'intramedullary nailing', 'augmented locking plate fixation Group LP or multiplanar intramedullary nailing Group IN']","['mean Constant Murley Score', 'Screw cutting out', 'low complication- and revision rates', 'quality of fracture reduction', 'mean DASH-Scores', 'Disabilities of the Shoulder, Arm and Hand', 'DASH', 'age- and gender adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score (ASES), the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36', 'Revision surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",60.0,0.0407942,"Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Helfen', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany. Electronic address: tobias.helfen@med.uni-muenchen.de.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Siebenbürger', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Fleischhacker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Gleich', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ockert', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}]",Injury,['10.1016/j.injury.2020.06.026']
2127,32637032,"Postoperative atrial fibrillation does not impact on overall survival after esophagectomy in patients with thoracic esophageal cancer: results from a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Administration of landiolol hydrochloride was found to be associated with reduced incidence of atrial fibrillation (AF) after esophagectomy for esophageal cancer in our previous randomized controlled trial (RCT). In addition, reduced incidence of AF was associated with reduction of other complications. Meanwhile, the effects of postoperative AF and other complications on long-term survival following esophagectomy are not well understood.
MATERIALS AND METHODS


Between March 2014 and January 2016, 100 patients with esophageal cancer were registered in an RCT trial and randomly allocated to receive either administration of landiolol or a placebo. We analyzed data from this RCT to better understand the effect of postoperative AF and severe associated complications on overall survival (OS) after esophagectomy for cancer. We also examined whether prophylactic administration of landiolol hydrochloride directly affects prolonged survival in patients with esophageal cancer.
RESULTS


The five-year rates of OS in the patients with and without AF were 60%, and 68.6%, respectively, there was no significant difference ( P  = 0.328). Five-year rates of OS of the patients with and without severe complications were 64.6%, and 67.5%, respectively ( P  = 0.995). The five-year rates of OS in the placebo and landiolol groups were 65.8% and 68%, respectively ( P  = 0.809). In multivariate analysis, high stage (stage III/IV) alone was an independent prognostic factor for esophageal cancer patients following esophagectomy.
CONCLUSIONS


New-onset AF and the other severe complications were not associated with poorer long-term survival following esophagectomy. In addition, administration of landiolol hydrochloride after esophagectomy did not contribute to prolonging the OS.",2020,"In multivariate analysis, high stage (stage III/IV) alone was an independent prognostic factor for esophageal cancer patients following esophagectomy.
","['Between March 2014 and January 2016, 100 patients with esophageal cancer', 'patients with thoracic esophageal cancer', 'esophageal cancer patients following esophagectomy', 'patients with esophageal cancer']","['landiolol hydrochloride', 'landiolol or a placebo', 'placebo']","['reduced incidence of AF', 'overall survival', 'prolonged survival', 'severe complications', 'atrial fibrillation (AF', 'overall survival (OS']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",100.0,0.711897,"In multivariate analysis, high stage (stage III/IV) alone was an independent prognostic factor for esophageal cancer patients following esophagectomy.
","[{'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Hayata', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kitadani', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Katsuda', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Mikihito', 'Initials': 'M', 'LastName': 'Nakamori', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takeuchi', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Maruoka', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fukuda', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Shinta', 'Initials': 'S', 'LastName': 'Tominaga', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Motobayashi', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaue', 'Affiliation': 'Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.'}]",Oncotarget,['10.18632/oncotarget.27643']
2128,32637101,Interpretation bias modification to reduce body dissatisfaction - a randomized controlled pilot study in women with elevated weight and shape concerns.,"Background


Recent research has identified several cognitive biases in patients with eating disorders, such as a tendency to interpret ambiguous information about one's own body in a negative way. The so-called ""negative interpretation bias"" is considered to be a key factor in maintaining maladaptive cognitions and behaviors in eating disorders. Studies on modification of the negative interpretation bias in eating disorders have yielded mixed results. This randomized controlled pilot study examined whether a specially adapted, computerized version of the Scrambled Sentences Task modifies negative interpretation bias in women with elevated body dissatisfaction.
Methods


The sample consisted of 40 normal-weight women with elevated body dissatisfaction, randomly assigned either to an intervention or a no-intervention control group (each  n  = 20). The intervention group received six sessions (within two weeks) of a newly-developed interpretation bias modification training that involved unscrambling positively valenced, body image-related sentences. The control group received no intervention. In both groups, body image-related negative interpretation bias (main outcome), trait body dissatisfaction and thin-ideal cue reactivity were assessed at baseline and two weeks later. Additionally, in the intervention condition, the trajectory of expected reductions in the thin-ideal internalization was measured during each training session.
Results


In both conditions, body image-related negative interpretation bias and trait body dissatisfaction decreased significantly from pre- to post-assessment; however, a specific effect imparted by the interpretation bias modification training was not found. Groups did not differ in thin-ideal cue reactivity. In the intervention group, thin-ideal internalization decreased significantly over the training sessions.
Conclusions


The findings do not support use of body image-related interpretation bias modification in its current form in the treatment of body dissatisfaction. Further research involving different versions of the training and clinical samples is warranted.",2020,"This randomized controlled pilot study examined whether a specially adapted, computerized version of the Scrambled Sentences Task modifies negative interpretation bias in women with elevated body dissatisfaction.
","['patients with eating disorders', 'women with elevated body dissatisfaction', '40 normal-weight women with elevated body dissatisfaction', 'women with elevated weight and shape concerns']","['six sessions (within two weeks) of a newly-developed interpretation bias modification training that involved unscrambling positively valenced, body image-related sentences', 'intervention or a no-intervention control', 'no intervention', 'specially adapted, computerized version of the Scrambled Sentences Task']","['body image-related negative interpretation bias and trait body dissatisfaction', 'trait body dissatisfaction and thin-ideal cue reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",40.0,0.0584963,"This randomized controlled pilot study examined whether a specially adapted, computerized version of the Scrambled Sentences Task modifies negative interpretation bias in women with elevated body dissatisfaction.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bradatsch', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Marlene Dorit', 'Initials': 'MD', 'LastName': 'Vahl', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Potterton', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Gordon', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brockmeyer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Goettingen, Goettingen, Germany.'}]",Journal of eating disorders,['10.1186/s40337-020-00305-4']
2129,32637105,"""Food is something everyone should participate in"": A positive deviance approach to understanding the use of a food and nutrition app in low-income, Latino homes.","Objectives


Latino families are among the most likely to be overweight or obese, which are conditions associated with numerous health risks and diseases. These families might lack know-how for preparing vegetables that fall outside cooks' culinary comfort zones and cultural traditions. Mobile apps are increasingly being developed for healthier cooking and eating, but research has not much explored how such apps are used among these families to help facilitate changes in eating patterns. This research seeks to identify behaviors and motivations that lead household cooks (i.e. mothers) in low-income Latino homes to use a food and nutrition app and create healthier eating environments for their families.
Methods


This study uses a positive deviance approach and individual interviews with mothers who were frequent app users and experienced beneficial food outcomes during their participation in a randomized controlled trial that tested the effects of an app on their cooking and family eating behaviors. Interviews were analyzed for themes using a framework analysis approach.
Results


Three themes emerged across interviews that were suggestive of approaches that led mothers to become frequent app users and prepare healthier meals: (1) mothers invited their children to use the app; (2) they involved both sons and daughters in the kitchen; and (3) they (cautiously) stepped outside their culinary comfort zones.
Conclusion


Mobile apps and app-focused interventions should include features that invite: app co-use between mothers and children; opportunities for mothers to socialize boys, as well as girls into kitchen routines; and the use of culturally-familiar ingredients or recipes that are easily adaptable.",2020,"Mobile apps are increasingly being developed for healthier cooking and eating, but research has not much explored how such apps are used among these families to help facilitate changes in eating patterns.",['mothers who were frequent app users'],[],['healthier meals'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],"[{'cui': 'C1998602', 'cui_str': 'Meals'}]",,0.0347362,"Mobile apps are increasingly being developed for healthier cooking and eating, but research has not much explored how such apps are used among these families to help facilitate changes in eating patterns.","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Neffa-Creech', 'Affiliation': 'Sentient Research, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Annenberg School for Communication and Journalism, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Evans', 'Affiliation': 'Annenberg School for Communication and Journalism, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Glovinsky', 'Affiliation': 'Fruitstitute, Los Angeles, CA, USA.'}]",SAGE open medicine,['10.1177/2050312120934842']
2130,32637113,Mobile Health for Cardiovascular Disease: The New Frontier for AF Management: Observations from the Huawei Heart Study and mAFA-II Randomised Trial.,,2020,,['Cardiovascular Disease'],[],[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],[],,0.0640203,,"[{'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Gregory Yh', 'Initials': 'GY', 'LastName': 'Lip', 'Affiliation': 'Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}]",Arrhythmia & electrophysiology review,['10.15420/aer.2020.12']
2131,32637118,The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE) Study Results in Context.,"The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration (CIRCA-DOSE) study was a multicentre, randomised, single-blinded trial that compared contact-force radiofrequency ablation and two different regimens of cryoballoon ablation. All patients received an implantable cardiac monitor for the purpose of continuous rhythm monitoring, with all arrhythmia events undergoing independent adjudication by a committee blinded to treatment allocation. The study demonstrated there were no significant differences between contact-force radiofrequency ablation and cryoballoon ablation with respect to recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden. While the results of the CIRCA-DOSE study are reviewed here, this article focuses on considerations around the design of the study and places the observed outcomes in context.",2020,"The study demonstrated there were no significant differences between contact-force radiofrequency ablation and cryoballoon ablation with respect to recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden.",[],"['Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration (CIRCA-DOSE', 'contact-force radiofrequency ablation', 'cryoballoon ablation', 'implantable cardiac monitor', 'Cryoballoon vs Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE']","['recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden']",[],"[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",,0.0420078,"The study demonstrated there were no significant differences between contact-force radiofrequency ablation and cryoballoon ablation with respect to recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden.","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, University of Montreal, Montreal, Canada.'}]",Arrhythmia & electrophysiology review,['10.15420/aer.2019.13']
2132,32637348,Effect of Different Levels of Positive End-Expiratory Pressure (PEEP) on Respiratory Status during Gynecologic Laparoscopy.,"Background


During gynecologic laparoscopy, pneumoperitoneum, and the position of the patient's head can lead to pathophysiologic changes in cardiovascular and respiratory systems, complicating the management of anesthesia in these patients. One of the strategies for improving the respiratory status of patients undergoing laparoscopy is the use of Positive End-Expiratory Pressure (PEEP).
Objectives


This study aimed to evaluate the effect of different levels of PEEP on the respiratory status of patients undergoing gynecologic laparoscopy.
Methods


In this clinical trial, 60 patients with ASA I were randomly assigned to three groups to control anesthesia: ZEEP (PEEP 0 cmH 2 O; 20 cases), PEEP 5  (PEEP 5 cmH 2 O; 20 cases), and PEEP 10  (PEEP 10 cmH 2 O; 20 cases). Respiratory and hemodynamic variables of patients were compared before general anesthetic induction and immediately after CO 2  insufflation at intervals of 5, 10, 20, 30, and 60 min and the end of the operation in the three study groups.
Results


The PEEP application improved pH, PaCO 2 , and PaO 2  levels at the end of pneumoperitoneum compared to baseline when compared with the non-use of PEEP (ZEEP group). Also, the frequency of dysrhythmia in the use of PEEP in controlled ventilation was significantly lower in patients with PEEP 10  (P < 0.05). The application of PEEP 5  resulted in similar effects to PEEP 10  in the levels of respiratory variables.
Conclusions


The PEEP application is associated with improved arterial blood gas in patients with gynecologic laparoscopy. The use of PEEP 10  has a greater effect on the improvement of respiratory parameters and complications of pneumoperitoneum.",2020,"The PEEP application improved pH, PaCO 2 , and PaO 2  levels at the end of pneumoperitoneum compared to baseline when compared with the non-use of PEEP (ZEEP group).","['patients undergoing', 'patients undergoing gynecologic laparoscopy', '60 patients with ASA I', 'patients with gynecologic laparoscopy']","['control anesthesia: ZEEP (PEEP 0', 'PEEP', 'laparoscopy', 'Positive End-Expiratory Pressure (PEEP', 'PEEP (ZEEP']","['frequency of dysrhythmia in the use of PEEP in controlled ventilation', 'pH, PaCO 2 , and PaO 2  levels', 'arterial blood gas']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}]",60.0,0.0967915,"The PEEP application improved pH, PaCO 2 , and PaO 2  levels at the end of pneumoperitoneum compared to baseline when compared with the non-use of PEEP (ZEEP group).","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Atashkhoei', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Yavari', 'Affiliation': 'Research Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Zarrintan', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Bilejani', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Zarrintan', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of General & Vascular Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.100075']
2133,32637360,Long-Term Survival of Patients With Chemotherapy-Naïve Metastatic Nasopharyngeal Carcinoma Receiving Cetuximab Plus Docetaxel and Cisplatin Regimen.,"Purpose:  Metastatic nasopharyngeal carcinoma (mNPC) remains incurable. This prospective study aimed to investigate whether adding cetuximab to cisplatin-based induction therapy could improve efficacy and survival for chemotherapy-naïve mNPC patients.  Patients and Methods:  Eligible chemotherapy-naïve mNPC patients were enrolled, including those initially diagnosed with mNPC (IM) and those with first-relapse metastases after radiotherapy (RM). Patients all received induction chemotherapy (IC) including docetaxel and cisplatin plus cetuximab. Those who obtained objective remission after IC would continue to receive radiotherapy concurrent with cetuximab and cisplatin, and further capecitabine as maintenance. Contemporaneous patients who received conventional therapy served as controls.  Results:  Forty-three patients were enrolled, including 17 IM and 26 RM patients. Thirty-nine (90.7%) patients had WHO III subtype. The overall response and complete response (CR) rates were, respectively, 79.1 and 34.9% after induction therapy and 76.7 and 46.5% after chemoradiotherapy. The 5-year overall survival (OS) and progression-free survival (PFS) rates reached 34.9 and 30%, respectively. Subgroup analysis showed that compared with RM patients, IM patients had a higher 5-year OS (58.8 vs. 19.2%) and PFS (52.9 vs. 19.2%). The IM group had a higher CR rate of induction treatment than the RM group (52.9 vs. 23.1%). No treatment-related death was observed. Twelve patients (27.9%) remained alive with disease-free survival times from 60+ to 135+ months. Control patients showed a substantially lower survival rate (5-year OS, 10.9%) and few long-term survivors.  Conclusions:  This regimen resulted in significantly improved efficacy and survival, which indicates a potentially curative role for chemotherapy-naïve mNPC, especially in newly diagnosed patients. A phase III clinical trial (NCT02633176) is ongoing for confirmation.",2020,"The 5-year overall survival (OS) and progression-free survival (PFS) rates reached 34.9 and 30%, respectively.","['Forty-three patients were enrolled, including 17 IM and 26 RM patients', 'patients had WHO III subtype', 'Thirty-nine (90.7', 'Patients and Methods:  Eligible chemotherapy-naïve mNPC patients were enrolled, including those initially diagnosed with mNPC (IM) and those with first-relapse metastases after radiotherapy (RM', 'chemotherapy-naïve mNPC patients', 'newly diagnosed patients']","['Cetuximab Plus Docetaxel and Cisplatin Regimen', 'cetuximab to cisplatin-based induction therapy', 'radiotherapy concurrent with cetuximab and cisplatin', 'capecitabine', 'induction chemotherapy (IC) including docetaxel and cisplatin plus cetuximab', 'conventional therapy']","['PFS', 'overall response and complete response (CR) rates', 'death', 'CR rate', '5-year overall survival (OS) and progression-free survival (PFS) rates', 'survival rate', 'alive with disease-free survival times', 'efficacy and survival', '5-year OS']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0208102', 'cui_str': '3-nitrophenyl 3-piperidinecarboxylate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",43.0,0.0447502,"The 5-year overall survival (OS) and progression-free survival (PFS) rates reached 34.9 and 30%, respectively.","[{'ForeName': 'Mengping', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Sioteng', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Huangming', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Taixiang', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01011']
2134,32637386,An Evaluation of Three Ways of Communicating Carrier Status Results to the Parents of Children in a Neonatal Sickle Cell Screening Programme.,"Aim:  Sickle cell disease (SCD) is the most frequent monogenic disease worldwide; ~5-7% of the world population carry a hemoglobin disorder trait. In the US, one in every 1,941 newborns has SCD, whereas one in every 3,000 newborns in France is affected - resulting in 385 new cases and 5,883 newly identified carriers per year. The objective of the present study was to evaluate three different ways of providing information to parents at risk of having a child with SCD, with a view to increasing the parental screening rate and decreasing the number of new cases per year in France.  Method:  In a randomized study, we contacted 300 couples of parents after their child had been identified as a SCD carrier in the French national newborn screening programme: 100 couples received an information letter (the standard procedure in France: arm A), 100 couples received a letter and then a follow-up phone call (arm B), and 100 received a letter and then three follow-up text messages at 5-day intervals (arm C). The primary endpoint was the number of parents in each arm screened in the 120 days after the letter had been sent. In a modified intention-to-treat analysis, the screening rate was 17% in arm A, 35% in arm B, and 30% in arm C.  Results:  Telephone and text message follow-ups were associated with higher screening rates, compared with no follow-up. After being informed of their child's carrier status, some parents had consulted a healthcare professional but had not been referred for screening (16% in arm A, 19% in arm B, and 13% in arm C).  Conclusion:  A letter followed by a phone call or three text messages is more effective than a letter alone for informing parents at risk of having a child with SCD. The effective implementation of this follow-up programme probably requires better training of all the healthcare professionals involved.",2020,A letter followed by a phone call or three text messages is more effective than a letter alone for informing parents at risk of having a child with SCD.,"['300 couples of parents after their child had been identified as a SCD carrier in the French national newborn screening programme: 100 couples received an', '1,941 newborns has SCD, whereas one in every 3,000 newborns in France is affected - resulting in 385 new cases and 5,883 newly identified carriers per year', 'parents at risk of having a child with SCD', 'Parents of Children in a Neonatal Sickle Cell Screening Programme']",['information letter'],"['screening rate', 'number of parents in each arm screened']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0027617', 'cui_str': 'Neonatal screening'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",,0.0437939,A letter followed by a phone call or three text messages is more effective than a letter alone for informing parents at risk of having a child with SCD.,"[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Rémus', 'Affiliation': 'Département de Génétique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Stanislas', 'Affiliation': ""Centre d'Investigation Clinique de Biothérapie, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Naïm', 'Initials': 'N', 'LastName': 'Bouazza', 'Affiliation': 'Unité de Recherche Clinique Necker-Cochin, Assistance Publique-Hôpitaux de Paris - EA 7323, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Gauthereau', 'Affiliation': ""Fédération Parisienne pour le Dépistage, la Prévention du Handicap chez l'Enfant, Paris, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': ""Fédération Parisienne pour le Dépistage, la Prévention du Handicap chez l'Enfant, Paris, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanche', 'Affiliation': ""Unité d'Immuno-Hématologie Pédiatrique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Assa', 'Initials': 'A', 'LastName': 'Niakaté', 'Affiliation': ""Centre d'Information et de Dépistage de la Drépanocytose, Paris, France.""}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Gluckman', 'Affiliation': 'Centre Scientifique de Monaco, Eurocord, Hopital Saint Louis, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'Unité de Recherche Clinique Necker-Cochin, Assistance Publique-Hôpitaux de Paris - EA 7323, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Munnich', 'Affiliation': 'Département de Génétique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Girot', 'Affiliation': 'Département de Génétique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cavazzana', 'Affiliation': ""Centre d'Investigation Clinique de Biothérapie, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.""}]",Frontiers in pediatrics,['10.3389/fped.2020.00300']
2135,32637458,Effects of Depth of Anesthesia Monitored by IoC on Patients Undergoing Laparoscopic Radical Resection of Colorectal Cancer.,"Index of consciousness (IoC) consisting of IoC1 and IoC2, is a new analgesia monitoring indicator in anesthesia evaluation in the laparoscopic radical resection of colorectal cancer. Although the precise anesthetic dosage adjusted by IoC1 has been confirmed to enhance the recovery and reduce the complications of anesthesia, the most appropriate range of IoC2 during anesthesia remains unclear. To investigate the correlation between IoC2 and peri-operative indicators of patients during laparoscopic radical resection of colorectal cancer, the current randomized, controlled, and single-blinded clinical trial was performed. Participants were divided randomly into three groups with different anesthesia depth monitored by IoC2 during their laparoscopic radical resections. Primary outcomes included the dosage of remifentanil. Secondary outcomes included other physiological indexes and complications. The remifentanil dosage and the awakening time increased as IoC2 decreased. The incidences of hypotension and hypoxemia decreased with the elevated IoC2, but the risk of intra-operative awareness also increased. The impact caused by anesthesia to the immune system and health-related life quality of the patients descended with reduced anesthetic level. The IoC2 range of 35-45 could represent the most appropriate anesthetic depth during laparoscopic radical resection, which provides a new perspective for the clinical treatment of colon cancer.",2020,The impact caused by anesthesia to the immune system and health-related life quality of the patients descended with reduced anesthetic level.,"['laparoscopic radical resection of colorectal cancer', 'Patients Undergoing Laparoscopic Radical Resection of Colorectal Cancer', 'patients during laparoscopic radical resection of colorectal cancer']","['anesthesia depth monitored by IoC2 during their laparoscopic radical resections', 'Depth of Anesthesia Monitored by IoC', 'IoC1 and IoC2']","['awakening time', 'physiological indexes and complications', 'hypotension and hypoxemia', 'dosage of remifentanil']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1139879', 'cui_str': 'Anesthesia depth monitor'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",,0.0394846,The impact caused by anesthesia to the immune system and health-related life quality of the patients descended with reduced anesthetic level.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 248-252 Dong Road, Quanzhou 362000, China.'}, {'ForeName': 'Zhenming', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 248-252 Dong Road, Quanzhou 362000, China.'}, {'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 248-252 Dong Road, Quanzhou 362000, China.'}, {'ForeName': 'Huimei', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 248-252 Dong Road, Quanzhou 362000, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, No. 248-252 Dong Road, Quanzhou 362000, China.'}]",Molecular therapy. Methods & clinical development,['10.1016/j.omtm.2020.05.032']
2136,30506579,Amplification of endothelium-dependent vasodilatation in contracting human skeletal muscle: role of K IR  channels.,"KEY POINTS


In humans, the vasodilatory response to skeletal muscle contraction is mediated in part by activation of inwardly rectifying potassium (K IR  ) channels. Evidence from animal models suggest that K IR  channels serve as electrical amplifiers of endothelium-dependent hyperpolarization (EDH). We found that skeletal muscle contraction amplifies vasodilatation to the endothelium-dependent agonist ACh, whereas there was no change in the vasodilatory response to sodium nitroprusside, an endothelium-independent nitric oxide donor. Blockade of K IR  channels reduced the exercise-induced amplification of ACh-mediated vasodilatation. Conversely, pharmacological activation of K IR  channels in quiescent muscle via intra-arterial infusion of KCl independently amplified the vasodilatory response to ACh. This study is the first in humans to demonstrate that specific endothelium-dependent vasodilatory signalling is amplified in the vasculature of contracting skeletal muscle and that K IR  channels may serve as amplifiers of EDH-like vasodilatory signalling in humans.
ABSTRACT


The local vasodilatory response to muscle contraction is due in part to the activation of inwardly rectifying potassium (K IR  ) channels. Evidence from animal models suggest that K IR  channels function as 'amplifiers' of endothelium-dependent vasodilators. We tested the hypothesis that contracting muscle selectively amplifies endothelium-dependent vasodilatation via activation of K IR  channels. We measured forearm blood flow (Doppler ultrasound) and calculated changes in vascular conductance (FVC) to local intra-arterial infusion of ACh (endothelium-dependent dilator) during resting conditions, handgrip exercise (5% maximum voluntary contraction) or sodium nitroprusside (SNP; endothelium-independent dilator) which served as a high-flow control condition (n = 7, young healthy men and women). Trials were performed before and after blockade of K IR  channels via infusion of barium chloride. Exercise augmented peak ACh-mediated vasodilatation (ΔFVC saline: 117 ± 14; exercise: 236 ± 21 ml min -1  (100 mmHg) -1  ; P < 0.05), whereas SNP did not impact ACh-mediated vasodilatation. Blockade of K IR  channels attenuated the exercise-induced augmentation of ACh. In eight additional subjects, SNP was administered as the experimental dilator. In contrast to ACh, exercise did not alter SNP-mediated vasodilatation (ΔFVC saline: 158 ± 35; exercise: 121 ± 22 ml min -1  (100 mmHg) -1  ; n.s.). Finally, in a subset of six subjects, direct pharmacological activation of K IR  channels in quiescent muscle via infusion of KCl amplified peak ACh-mediated vasodilatation (ΔFVC saline: 97 ± 15, KCl: 142 ± 16 ml min -1   (100 mmHg) -1  ; respectively; P < 0.05). These findings indicate that skeletal muscle contractions selectively amplify endothelium-dependent vasodilatory signalling via activation of K IR  channels, and this may be an important mechanism contributing to the normal vasodilatory response to exercise in humans.",2019,Exercise augmented peak ACh-mediated vasodilatation (ΔFVC saline: 117 ± 14; exercise: 236 ± 21 ml min -1  ,"['contracting human skeletal muscle', 'n\xa0= 7, young healthy men and women']","['Exercise augmented peak ACh-mediated vasodilatation (ΔFVC saline', 'endothelium-dependent vasodilatation', 'sodium nitroprusside (SNP; endothelium-independent dilator) which served as a high-flow control condition', 'exercise: 236\xa0± 21\xa0ml\xa0min -1', 'sodium nitroprusside']",['forearm blood flow (Doppler ultrasound) and calculated changes in vascular conductance (FVC) to local intra-arterial infusion of ACh (endothelium-dependent dilator'],"[{'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021439', 'cui_str': 'Intra-arterial infusion'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}]",,0.0429316,Exercise augmented peak ACh-mediated vasodilatation (ΔFVC saline: 117 ± 14; exercise: 236 ± 21 ml min -1  ,"[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hearon', 'Affiliation': 'Human Cardiovascular Physiology Laboratory, Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Richards', 'Affiliation': 'Human Cardiovascular Physiology Laboratory, Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Mathew L', 'Initials': 'ML', 'LastName': 'Racine', 'Affiliation': 'Human Cardiovascular Physiology Laboratory, Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Luckasen', 'Affiliation': 'Medical Center of the Rockies Foundation, University of Colorado Health, Loveland, CO, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'Larson', 'Affiliation': 'Medical Center of the Rockies Foundation, University of Colorado Health, Loveland, CO, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Dinenno', 'Affiliation': 'Human Cardiovascular Physiology Laboratory, Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, 80523, USA.'}]",The Journal of physiology,['10.1113/JP276998']
2137,30846496,A clinico-molecular predictor identifies follicular lymphoma patients at risk of early transformation after first-line immunotherapy.,,2019,,['follicular lymphoma patients at risk of early transformation after first-line immunotherapy'],[],[],"[{'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",[],[],,0.0132065,,"[{'ForeName': 'Chloé B', 'Initials': 'CB', 'LastName': 'Steen', 'Affiliation': 'Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Leich', 'Affiliation': 'Institute of Pathology, University of Würzburg and Comprehensive Cancer Centre Mainfranken, Germany.'}, {'ForeName': 'June H', 'Initials': 'JH', 'LastName': 'Myklebust', 'Affiliation': 'Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lockmer', 'Affiliation': 'Division of Haematology, Department of Medicine at Huddinge, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jillian F', 'Initials': 'JF', 'LastName': 'Wise', 'Affiliation': 'Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Wahlin', 'Affiliation': 'Division of Haematology, Department of Medicine at Huddinge, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Østenstad', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Liestøl', 'Affiliation': 'Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kimby', 'Affiliation': 'Division of Haematology, Department of Medicine at Huddinge, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Würzburg and Comprehensive Cancer Centre Mainfranken, Germany.'}, {'ForeName': 'Erlend B', 'Initials': 'EB', 'LastName': 'Smeland', 'Affiliation': 'Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Holte', 'Affiliation': 'KG Jebsen Centre for B-Cell Malignancies, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjærde', 'Affiliation': 'Department of Informatics, University of Oslo, Oslo, Norway ole@ifi.uio.no.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodtkorb', 'Affiliation': 'Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway meide@ous-hf.no.'}]",Haematologica,['10.3324/haematol.2018.209080']
2138,32637718,"Cardiovascular, endothelial function, and immune markers in response to treatment with a polysaccharide in HIV +  adults in a randomized, double-blind placebo-controlled trial.","Background and Aim


Given the ongoing problems of hypertension and endothelial dysfunction in the HIV population, the primary objective of the study was to assess the cardiovascular, endothelial function, and immune markers in response to rice bran arabinoxylan compound (RBAC) treatment in a sample of HIV +  adults on antiretroviral therapy (ART).
Study Design


A randomized, double-blind placebo-controlled trial of 6 months was used to execute the study.
Materials and Methods


Forty-seven subjects were enrolled and randomly assigned to one of two study conditions ( n =22 RBAC and  n =25 placebo) for 6 months with assessments at baseline and 3 and 6 months. A multivariate repeated measures analysis of variance model was used to assess the differences between RBAC and placebo groups in cardiovascular (systolic blood pressure), endothelial function (skin blood flow in response to nitric oxide), and immune (CD4 +  cell count) markers from baseline to 6 months.
Results


The effect of treatment (RBAC versus placebo) was significant (Wilks' λ=0.92, F[3, 102]=3.07,  P =0.03). The effect of time was significant (Wilks' λ=0.10, F[2, 103]=474.6,  P <0.001). The overall interaction between treatment and time was significant (Wilks' λ=0.92, F[2, 103]=4.58,  P =0.01). Time contrasts showed that a difference in the overall dependent variable did not occur from baseline to 3 months (F[1, 104]=2.7,  P =0.10), marginally occurred from baseline to 6 months (F[1, 104]=3.2,  P =0.08), and was significant from 3 to 6 months (F[1, 104]=6.43,  P =0.01).
Conclusions


The overall significant interaction suggests varying responses in the dependent variables between RBAC and placebo over time, which is being driven by systolic blood pressure, as it decreased in the RBAC group, but increased in the placebo group. In addition, CD4 +  manifested a non-significant increase from baseline to 3 months then decreased from 3 to 6 months in the RBAC group, whereas it decreased at 3 months followed by a slight increase at 6 months in the placebo group. Skin blood flow in response to nitric oxide improved non-significantly overall in both groups, but worsened from 3 to 6 months in the placebo group. Thus, RBAC treatment may contribute to modest short-term improvements in systolic blood pressure, endothelial function, and CD4 +  cell count, which could help improve the overall health profile of HIV +  adults.
Relevance for Patients


Persons with HIV on ART suffer disproportionately from hypertension and endothelial dysfunction compared to the non-infected population, and conventional medical therapy does not alleviate these issues. RBAC is a safe, low-risk alternative that may help to improve the overall quality of life of these patients through modest improvements in these biomarkers plus CD4 +  cell count.",2020,"Skin blood flow in response to nitric oxide improved non-significantly overall in both groups, but worsened from 3 to 6 months in the placebo group.","['Materials and Methods\n\n\nForty-seven subjects', 'in HIV +  adults', 'Patients\n\n\nPersons with HIV', 'a sample of HIV +  adults on antiretroviral therapy (ART']","['RBAC', 'polysaccharide', 'treatment (RBAC versus placebo', 'rice bran arabinoxylan compound (RBAC', 'RBAC and  n =25 placebo', 'placebo']","['systolic blood pressure, endothelial function, and CD4 +  cell count', 'Cardiovascular, endothelial function, and immune markers', 'systolic blood pressure', 'cardiovascular (systolic blood pressure), endothelial function (skin blood flow in response to nitric oxide), and immune (CD4 +  cell count) markers', 'Skin blood flow']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0982374', 'cui_str': 'RICE BRAN'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",47.0,0.449424,"Skin blood flow in response to nitric oxide improved non-significantly overall in both groups, but worsened from 3 to 6 months in the placebo group.","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Atlas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Muhammad H', 'Initials': 'MH', 'LastName': 'Abbas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Rasul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ashar', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lantigua', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Lages', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jinrun', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Barclay's, Inc., Wilmington, DE, USA.""}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Higuera', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiallo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judi M', 'Initials': 'JM', 'LastName': 'Woolger', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ciraula', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Konefal', 'Affiliation': ""Barclay's, Inc., Wilmington, DE, USA.""}]",Journal of clinical and translational research,[]
2139,32637721,"Rationale, design and study protocol of the 'Strong Families Start at Home' feasibility trial to improve the diet quality of low-income, ethnically diverse children by helping parents improve their feeding and food preparation practices.","There is an urgent need to create effective interventions that help parents establish a healthy diet among their children early in life, especially among low-income and ethnically and racially diverse families. U.S. children eat too few fruits, vegetables and whole grains, and too many energy dense foods, dietary behaviors associated with increased morbidity from chronic diseases. Parents play a key role in shaping children's diets. Best practices suggest that parents should involve children in food preparation, and offer, encourage and model eating a variety of healthy foods. In addition, while parents help to shape food preferences, not all children respond in the same way. Certain child appetitive traits, such as satiety responsiveness (sensitivity to internal satiety signals), food responsiveness (sensitivity to external food cues), and food fussiness may help explain some of these differences. Prior interventions to improve the diet of preschool children have not used a holistic approach that targets the home food environment, by focusing on food quality, food preparation, and positive feeding practices while also acknowledging a child's appetitive traits. This manuscript describes the rationale and design for a 6-month pilot randomized controlled trial, Strong Families Start at Home, that randomizes parents and their 2-to 5-year old children to either a home-based environmental dietary intervention or an attention-control group. The primary aim of the study is to explore the feasibility and acceptability of the intervention and evaluation and to determine the intervention's preliminary efficacy on child diet quality, feeding practices, and availability of healthy foods in the home.",2020,"There is an urgent need to create effective interventions that help parents establish a healthy diet among their children early in life, especially among low-income and ethnically and racially diverse families.","['Strong Families Start at Home, that randomizes parents and their 2-to 5-year old children to either a', 'preschool children']",['home-based environmental dietary intervention or an attention-control group'],"['child diet quality, feeding practices, and availability of healthy foods']","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",,0.0349403,"There is an urgent need to create effective interventions that help parents establish a healthy diet among their children early in life, especially among low-income and ethnically and racially diverse families.","[{'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, 41 Lower College Road, Room 125, Kingston, RI, 02881, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gans', 'Affiliation': 'Department of Human Development and Family Studies, and Institute for Collaboration in Health, Interventions, and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McCurdy', 'Affiliation': 'Department of Human Development & Family Studies, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Patricia Markham', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Ernestine', 'Initials': 'E', 'LastName': 'Jennings', 'Affiliation': 'Center for Behavioral and Preventive Medicine, The Miriam Hospital, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gorin', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, Kingston, RI, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100583']
2140,32637723,"A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13-16 years (AMOS2): Rationale, study design, and patient recruitment.","Background


Previous non-randomized studies show similar outcomes in adolescents and adults after bariatric surgery. We describe the study protocol, recruitment, and selected baseline data of patients in a randomized multi-center study, the Adolescent Morbid Obesity Surgery 2 (AMOS2).
Methods


Three clinics in Sweden collaborated in designing the study and recruitment of patients from August 1, 2014 to June 30, 2017. Patients were selected among adolescents 13-16 years of age attending third-level obesity care for at least one year. Patients were randomized 1:1 to bariatric surgery (predominantly Roux-en-Y gastric bypass) or intensive non-surgical treatment starting with an eight-week low-calorie-diet.
Results


Fifty adolescents (37 girls) were randomized, 25 (19 girls) to bariatric surgery. Mean age was 15.7 years (range 13.3-16.9), weight 122.6 kg (range 95-183.3), Body Mass Index (BMI) 42.6 kg/m 2  (range 35.7-54.9) and BMI-SDS 3.45 (range 2.9-4.1). One patient had type 2 diabetes mellitus, and 12/45 (27%) had elevated liver enzymes. There were no significant differences between the groups. For the 39 eligible patients who were offered but declined inclusion, BMI was not different from included patients. However, patients who declined were younger, 15.2 years (p = 0.021). A sex difference was also noted with more of eligible girls, 37/53 (69.8%), than boys, 13/36 (36.1%), wanting to participate in the study (p = 0.002).
Conclusions


This clinical trial, randomizing adolescents with severe obesity to bariatric surgery or intensive non-surgical treatment, aims at informing about whether it is beneficial to undergo bariatric surgery in early adolescence. It will also enlighten the outcome of comprehensive non-surgical treatment. The study was registered at www.clinicalTrials.gov number NCT02378259.",2020,There were no significant differences between the groups.,"['adolescents aged 13-16 years (AMOS2', 'Methods\n\n\nThree clinics in Sweden collaborated in designing the study and recruitment of patients from August 1, 2014 to June 30, 2017', 'Mean age was 15.7 years (range 13.3-16.9), weight 122.6\xa0kg (range 95-183.3), Body Mass Index (BMI) 42.6', 'One patient had type 2 diabetes mellitus, and 12/45 (27%) had elevated liver enzymes', 'randomizing adolescents with severe obesity to bariatric surgery or intensive non-surgical treatment', '39 eligible patients who were offered but declined inclusion, BMI was not different from included patients', 'patients in a randomized multi-center study, the Adolescent Morbid Obesity Surgery 2 (AMOS2', 'adolescents and adults after bariatric surgery', 'Patients were selected among adolescents 13-16 years of age attending third-level obesity care for at least one year', 'Fifty adolescents (37 girls']","['bariatric surgery', 'intensive non-surgical treatment with bariatric surgery', 'bariatric surgery (predominantly Roux-en-Y gastric bypass) or intensive non-surgical treatment starting with an eight-week low-calorie-diet']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]",[],,0.128426,There were no significant differences between the groups.,"[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Janson', 'Affiliation': 'National Childhood Obesity Centre, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Kajsa', 'Initials': 'K', 'LastName': 'Järvholm', 'Affiliation': 'Childhood Obesity Unit, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gronowitz', 'Affiliation': 'Region Västra Götaland, Pediatric Obesity Center, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Sjögren', 'Affiliation': 'Region Västra Götaland, Pediatric Obesity Center, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Klaesson', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sweden.""}, {'ForeName': 'My', 'Initials': 'M', 'LastName': 'Engström', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Peltonen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ekbom', 'Affiliation': ""Division of Pediatric Endocrinology, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jovanna', 'Initials': 'J', 'LastName': 'Dahlgren', 'Affiliation': 'Region Västra Götaland, Pediatric Obesity Center, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Olbers', 'Affiliation': 'Department of Gastrosurgical Research, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100592']
2141,32637724,A prospective study of oral 5-aminolevulinic acid to prevent adverse events in patients with localized prostate cancer undergoing low-dose-rate brachytherapy: Protocol of the AMBER study.,"Background


Radiotherapy is one of the most frequently selected treatment options for patients with prostate cancer. However, adverse effects related to the irradiated surrounding normal organs are significant clinical concerns. Specifically, genitourinary and gastrointestinal toxicities can lead to a dramatically reduced quality of life. The aim of this clinical trial is to determine the efficacy of oral 5-aminolevulinic acid (ALA) phosphate with sodium ferrous citrate (SFC) in patients treated with low-dose-rate brachytherapy (LDR-BT) using an iodine-125 seed source.
Methods


The AMBER study is a prospective, single-center trial in patients with localized prostate cancer undergoing LDR-BT. Patients who undergo supplementary extra-beam radiotherapy are excluded, whereas those who undergo pre-implantation short-term (4-6 months) androgen deprivation therapy to decrease the prostate volume and/or improve oncological outcomes are included. After the screening and registration, the patients will be instructed to take capsules of ALA-SFC twice a day (200 mg and 229.42 mg per day) for 6 months from the day of seed implantation (prescribed radiation dose of 160 Gy). Patient data will be collected before the implantation; during oral ALA-SFC treatment; and 1, 3, 6, 9, and 12 month(s) after seed implantation. The primary endpoint of this trial is the urinary frequency 3 months after seed implantation. At each visit, the 24-h urinary frequency, total voided volume, and mean voided volume on a frequency volume chart and other patient-reported outcomes are recorded. The data of the trial cases will be compared with those of historical controls, who are consecutive patients undergoing LDR-BT without supplementary extra-beam radiotherapy between January 2016 and January 2019. The number of subjects has been set to be 50 for trial cases and 150 for the historical control cases. Pre- and post-treatment clinicopathologic factors are compared between two groups.
Discussion


The goal of this trial is to determine the potential benefit of ALA-SFC in patients who undergo LDR-BT. To the best of our knowledge, this is the first study investigating the potential clinical benefit of oral ALA-SFC after radiotherapy. More evidence from a further randomized controlled trial is needed to change the standard of care and lead to better post-radiotherapy management.
Trial registration


This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 5 December 2019. The reference number is jRCTs051190077, nara0013 (Certified Review Board of Nara Medical University).",2020,"At each visit, the 24-h urinary frequency, total voided volume, and mean voided volume on a frequency volume chart and other patient-reported outcomes are recorded.","['patients with localized prostate cancer undergoing low-dose-rate brachytherapy', 'patients who undergo LDR-BT', 'patients with localized prostate cancer undergoing LDR-BT', 'patients with prostate cancer', 'patients treated with low-dose-rate brachytherapy (LDR-BT) using an iodine-125 seed source', 'Japan Registry of Clinical Trials on 5 December 2019', 'Patients who undergo supplementary extra-beam radiotherapy are excluded, whereas those who undergo pre-implantation short-term (4-6 months']","['androgen deprivation therapy', 'oral 5-aminolevulinic acid (ALA) phosphate with sodium ferrous citrate (SFC', 'oral 5-aminolevulinic acid', 'LDR-BT without supplementary extra-beam radiotherapy', '\n\n\nRadiotherapy', 'ALA-SFC']","['quality of life', 'urinary frequency 3 months after seed implantation', 'adverse events', '24-h urinary frequency, total voided volume, and mean voided volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0454175', 'cui_str': 'Seeds source'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0066752', 'cui_str': 'monoferrous acid citrate'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.073322,"At each visit, the 24-h urinary frequency, total voided volume, and mean voided volume on a frequency volume chart and other patient-reported outcomes are recorded.","[{'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Asakawa', 'Affiliation': 'Department of Radiation Oncology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaki', 'Affiliation': 'Department of Radiation Oncology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shunta', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Anai', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Toritsuka', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Orthopedic Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Diagnostic Pathology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Ohbayashi', 'Affiliation': 'Department of Diagnostic Pathology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Radiation Oncology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kasahara', 'Affiliation': 'Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100593']
2142,32637725,Nitrous oxide as a putative novel dual-mechanism treatment for bipolar depression: Proof-of-concept study design and methodology.,"Introduction


Depressive symptoms predominate in the course of bipolar disorder (BD) and there is an urgent need to evaluate novel application of repurposed compounds that act on pre-specified treatment targets. Several lines of reasoning suggest that nitrous oxide (N 2 O) is an ideal medication to study as a potential treatment and as a strategy to identify the underlying pathophysiology of bipolar depression. N 2 O is a potent cerebral vasodilator and there is compelling evidence of reduced frontal cerebral blood flow (CBF; i.e. hypoperfusion) in depression. Therefore, N 2 O may increase CBF and thereby improve symptoms of depression. The goal of this randomized, double-blind trial is to study the effect of a single administration of N 2 O versus the active comparator midazolam on mood and CBF in adults with treatment-resistant bipolar depression.
Methods


Participants with BD-I/-II currently experiencing a major depressive episode will be randomized to one of two conditions (n = 20/group): 1) inhaled N 2 O plus intravenous saline, or 2) inhaled room air plus intravenous midazolam. Montgomery-Asberg Depression Rating Scale scores will serve as the primary endpoint. CBF will be measured via arterial spin labelling magnetic resonance imaging.
Conclusions


N 2 O is a potential novel treatment for bipolar depression, as it causes cerebral vasodilation. This proof-of-concept study will provide valuable information regarding the acute impact of N 2 O on mood and on CBF. If N 2 O proves to be efficacious in future larger-scale trials, its ubiquity, safety, low cost, and ease of use suggest that it has great potential to become a game-changing acute treatment for bipolar depression.",2020,"Methods


Participants with BD-I/-II currently experiencing a major depressive episode will be randomized to one of two conditions (n = 20/group): 1) inhaled N 2 O plus intravenous saline, or 2) inhaled room air plus intravenous midazolam.","['Methods\n\n\nParticipants with BD-I/-II currently experiencing a major depressive episode', 'adults with treatment-resistant bipolar depression']","['inhaled N 2 O plus intravenous saline, or 2) inhaled room air plus intravenous midazolam', 'nitrous oxide (N 2 O', 'Nitrous oxide', 'midazolam']","['symptoms of depression', 'Montgomery-Asberg Depression Rating Scale scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}]",,0.161201,"Methods


Participants with BD-I/-II currently experiencing a major depressive episode will be randomized to one of two conditions (n = 20/group): 1) inhaled N 2 O plus intravenous saline, or 2) inhaled room air plus intravenous midazolam.","[{'ForeName': 'Mikaela K', 'Initials': 'MK', 'LastName': 'Dimick', 'Affiliation': 'Pharmacology and Toxicology Department, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Omrin', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'MacIntosh', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachel H B', 'Initials': 'RHB', 'LastName': 'Mitchell', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Riegert', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Levitt', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Belo', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Iazzetta', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Garfield', 'Initials': 'G', 'LastName': 'Detzler', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Beverley A', 'Initials': 'BA', 'LastName': 'Orser', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Goldstein', 'Affiliation': 'Pharmacology and Toxicology Department, University of Toronto, Toronto, Ontario, Canada.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100600']
2143,32637860,Endometrial preparation using gonadotropin-releasing hormone agonist prior to frozen-thawed embryo transfer in women with repeated implantation failure: An RCT.,"Background


Preparation of endometrial thickness in frozen-thawed embryo transfer (FET) is extremely important, particularly in repeated implantation failure (RIF) patients.
Objective


This study aimed to investigate the clinical outcomes of FET cycles among RIF women, based on the effects of administering gonadotropin-releasing hormone (GnRH) agonist prior to estrogen-progesterone preparation of the endometrium.
Materials and Methods


In this randomized clinical trial, 67 infertile women who were candidates for FET were divided into two groups: A) case group (n = 34), treated with GnRH agonist prior to endometrial preparation and B) control group (n = 33), which received the routine protocol. (6 mg daily estradiol started from second day) The clinical outcomes) including chemical and clinical pregnancy, in addition to implantation rates, were compared between the two groups.
Results


The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699). Regarding pregnancy and implantation rates, there was a trend toward an increase in the case group; however, differences were not statistically significant.
Conclusion


Although our results showed no significant differences between groups. Because there are trends to better results in case group larger sample size may show significant difference.",2020,"The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699).","['women with repeated implantation failure', '67 infertile women who were candidates for FET', 'repeated implantation failure (RIF) patients', 'RIF women']","['GnRH agonist prior to endometrial preparation and B) control group', 'gonadotropin-releasing hormone agonist prior to frozen-thawed embryo transfer', 'gonadotropin-releasing hormone (GnRH) agonist prior to estrogen-progesterone', 'frozen-thawed embryo transfer (FET']","['pregnancy and implantation rates', 'chemical and clinical pregnancy, in addition to implantation rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}]",67.0,0.0825234,"The results showed no significant differences in women's age (p = 0.558), duration (p = 0.540), type (p = 0.562), and cause of infertility (p = 0.699).","[{'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Davar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Dashti', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i5.7150']
2144,32637875,"Comparison of prolene and progrip meshes in inguinal hernia repair in terms of post-operative pain, limitation of movement and quality of life.","Objectives


The study aimed to compare the techniques applying prolene mesh and progrip-self fixating mesh in terms of post-operative pain, limitation of movement and quality of life.
Material and Methods


The study was conducted from November 2014 to January 2016 in Department of Surgery, Manisa Celal Bayar University Hospital. The study recruited 50 male patients, aged 18 and over and was carried out as a double blinded procedure. Twenty-five patients were randomly selected to receive hernia repair by progrip self-fixating mesh and 25 patients were treated with hernia repair with suture fixation method by using prolene grafts, and patients' pain follow-up was performed with face-to-face or telephone interviews with VAS (Visual Analogue Scale) and return to daily routine activities were evaluated with SF-36 (Short Form-36) quality of life scale. Recurrent hernias and emergency cases were excluded.
Results


The pain scores were lower and a statistically significant difference was achieved in patients in whom progrip self-fixating mesh was used in the early postoperative period. Both methods gave statistically similar results in terms of pain and quality of life.
Conclusion


In the literature, there are some evidence that the repair applied with progrip self-fixating graft has more positive outcomes compared to the repairs applied with suture fixation. It is concluded that there is a need for longer follow-ups and larger series of cases in order to achieve a definite result.",2020,The pain scores were lower and a statistically significant difference was achieved in patients in whom progrip self-fixating mesh was used in the early postoperative period.,"['November 2014 to January 2016 in Department of Surgery, Manisa Celal Bayar University Hospital', 'Twenty-five patients', 'Recurrent hernias and emergency cases', '50 male patients, aged 18 and over and was carried out as a double blinded procedure']","['hernia repair by progrip self-fixating mesh', 'prolene and progrip meshes', ""hernia repair with suture fixation method by using prolene grafts, and patients' pain follow-up was performed with face-to-face or telephone interviews with VAS (Visual Analogue Scale) and return to daily routine activities"", 'techniques applying prolene mesh and progrip-self fixating mesh']","['SF-36 (Short Form-36) quality of life scale', 'pain scores', 'inguinal hernia repair in terms of post-operative pain, limitation of movement and quality of life', 'pain and quality of life', 'post-operative pain, limitation of movement and quality of life']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0917843', 'cui_str': 'Prolene'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.0642066,The pain scores were lower and a statistically significant difference was achieved in patients in whom progrip self-fixating mesh was used in the early postoperative period.,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Division of Surgical Oncology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Tutcu Şahin', 'Affiliation': 'Department of General Surgery, Celal Bayar University School of Medicine, Manisa, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of General Surgery, Celal Bayar University School of Medicine, Manisa, Turkey.'}, {'ForeName': 'Teoman', 'Initials': 'T', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Celal Bayar University School of Medicine, Manisa, Turkey.'}, {'ForeName': 'Aslan', 'Initials': 'A', 'LastName': 'Sakarya', 'Affiliation': 'Department of General Surgery, Celal Bayar University School of Medicine, Manisa, Turkey.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4451']
2145,32637890,The effect of co-morbid anxiety on remission from depression for people participating in a randomised controlled trial of the Friendship Bench intervention in Zimbabwe.,"Background


There is a lack of data from low- and middle-income countries on whether anxiety independently predicts a more chronic course for depression.
Methods


We undertook secondary data analysis of a cluster randomised controlled trial in Zimbabwe which had tested the effectiveness of the Friendship Bench intervention for common mental disorders compared to enhanced usual care. Inclusion for the current study was participants from the trial who had probable major depression at baseline, defined as scoring => 11 on the locally validated Patient Health Questionnaire (PHQ9). This emerged to be 354 of the original 573 (61.78%) of the original trial sample. Anxiety was measured using the locally validated cut-point on the Generalised Anxiety Disorder scale (GAD-7). Persistent depression was defined as scoring => 11 on the PHQ-9 at six-months follow-up. Analysis in Stata 15 used random-effects logistic regression to adjust for clustering by clinic.
Outcomes


Of the 354 participants who were eligible for treatment, 329 (92·9%) completed 6-month follow-up assessment. 37% of the trial sample had persistent depression at 6-months follow-up; 59% in the control arm and 17% in the intervention arm. Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32-6·07). There was no evidence of effect modification by trial arm. Baseline depression severity also predicted persistent depression.  Interpretation  Treatment for depression in low and middle-income countries (LMIC) should be directed towards those with greatest need. This includes people with co-morbid anxiety and greater depression severity at initial assessment who are less likely to remit at six months. Advice on coping with anxiety, psychological treatments which target common anxiety symptoms such as fear, avoidance, excessive worry and intrusive thoughts, and Selective Serotonin Reuptake Inhibitors (SSRIs) should be made more widely available in LMIC and offered to those with persistent mixed depression and anxiety.",2020,"Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32-6·07).","['participants from the trial who had probable major depression at baseline, defined as scoring ', '354 participants who were eligible for treatment, 329 (92·9%) completed 6-month follow-up assessment', 'people participating in a randomised controlled trial of the Friendship Bench intervention in Zimbabwe']","['co-morbid anxiety', 'Zimbabwe', 'Friendship Bench intervention']","['locally validated Patient Health Questionnaire (PHQ9', 'Generalised Anxiety Disorder scale (GAD-7', 'Anxiety', 'Persistent depression', 'persistent depression']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",573.0,0.16594,"Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32-6·07).","[{'ForeName': 'Melanie Amna', 'Initials': 'MA', 'LastName': 'Abas', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Simms', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Verhey', 'Affiliation': 'Research Support Centre, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Rusakaniko', 'Affiliation': 'Zimbabwe AIDS Prevention Project-University of Zimbabwe Department of Community Medicine, Harare, Zimbabwe.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Dixon', 'Initials': 'D', 'LastName': 'Chibanda', 'Affiliation': 'Research Support Centre, University of Zimbabwe, Harare, Zimbabwe.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100333']
2146,32637895,Final analysis of a 14-year long-term follow-up study of the effectiveness and immunogenicity of the quadrivalent human papillomavirus vaccine in women from four nordic countries.,"Background


The quadrivalent human papillomavirus (qHPV) vaccine prevented vaccine HPV type-related infection and disease in young women in the 4-year FUTURE II efficacy study (NCT00092534). We report long-term effectiveness and immunogenicity at the end of 14 years of follow-up after enrollment in FUTURE II.
Methods


Young women (16-23 years of age) from Denmark, Iceland, Norway, and Sweden who received three qHPV vaccine doses during the randomized, double-blind, placebo-controlled FUTURE II base study were followed for effectiveness for an additional ≥10 years through national registries. Tissue samples including but not limited to those collected during organized cervical cancer screening programs were obtained from regional biobanks to be adjudicated for histopathology diagnosis and tested for HPV DNA. The observed incidence of HPV16/18-related high-grade cervical dysplasia (primary outcome) was compared with recent historical background incidence rates in an unvaccinated population. Serum was collected at years 9 and 14 to assess antibody responses.
Findings


No cases of HPV16/18-related high-grade cervical dysplasia were observed in the per-protocol effectiveness population ( N  = 2121; 24,099·0 person-years of follow-up) during the entire study. Vaccine effectiveness of 100% (95% CI 94·7-100) was demonstrated for ≥12 years, with a trend toward continued protection through 14 years post-vaccination. Seropositivity rates at study conclusion were >90% (HPV6/11/16) and 52% (HPV18) using competitive Luminex immunoassay, and >90% (all four HPV types) using the more sensitive IgG Luminex immunoassay.
Interpretation


Vaccination of young women with qHPV vaccine offers durable protection against HPV16/18-related high-grade cervical dysplasia for ≥12 years, with a trend toward continued protection through 14 years post-vaccination, and induces sustained HPV6/11/16/18 antibody responses for up to 14 years post-vaccination. There was no evidence of waning immunity, suggesting no need for a booster dose during that period.
Funding


Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.",2020,"No cases of HPV16/18-related high-grade cervical dysplasia were observed in the per-protocol effectiveness population ( N  = 2121; 24,099·0 person-years of follow-up) during the entire study.","['Methods\n\n\nYoung women (16-23 years of age) from Denmark, Iceland, Norway, and Sweden who received three', 'young women with', 'young women', 'women from four nordic countries']","['placebo', 'quadrivalent human papillomavirus vaccine', 'qHPV vaccine']","['Vaccine effectiveness', 'Seropositivity rates', 'HPV16/18-related high-grade cervical dysplasia']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}]",,0.231585,"No cases of HPV16/18-related high-grade cervical dysplasia were observed in the per-protocol effectiveness population ( N  = 2121; 24,099·0 person-years of follow-up) during the entire study.","[{'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Unit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Research, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sundström', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.'}, {'ForeName': 'Laufey', 'Initials': 'L', 'LastName': 'Tryggvadottir', 'Affiliation': 'Icelandic Cancer Registry, Icelandic Cancer Society, Faculty of Medicine, BMC, Laeknagardur, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Munk', 'Affiliation': 'Unit of Virus, Lifestyle & Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'Department of Research, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Enerly', 'Affiliation': 'Department of Research, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hortlund', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Instituet, Stockholm, Sweden.'}, {'ForeName': 'Ágúst Ingi', 'Initials': 'ÁI', 'LastName': 'Ágústsson', 'Affiliation': 'Cancer Detection Clinic, Icelandic Cancer Society, Reykjavik, Iceland.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Bjelkenkrantz', 'Affiliation': 'Department of Clinical Pathology and Cytology, Unilabs, Eskilstuna, Sweden.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Fridrich', 'Affiliation': 'Akershus University Hospital, Norway.'}, {'ForeName': 'Ingibjorg', 'Initials': 'I', 'LastName': 'Guðmundsdóttir', 'Affiliation': 'Icelandic Cancer Society, Pathology, Reykjavík, Iceland.'}, {'ForeName': 'Sveinung Wergeland', 'Initials': 'SW', 'LastName': 'Sørbye', 'Affiliation': 'Department of Clinical Pathology, University Hospital of North Norway, Trømso, Norway.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bautista', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Group', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'J Brooke', 'Initials': 'JB', 'LastName': 'Marshall', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Yi Shen', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Badshah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100401']
2147,32637901,In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.,"Background


Bright IDEAS (BI) problem-solving skills training is an evidence-based intervention designed to help parents manage the demands of caring for a child with cancer. However, the resource intensiveness of this in-person intervention has limited its widespread delivery. We conducted a multicenter, randomized trial with a noninferiority design to evaluate whether a web-based version of BI requiring fewer resources is noninferior to in-person administration.
Methods


621 caregivers of children with newly diagnosed cancer were randomly assigned to standard BI delivered face-to-face or a web-based version delivered via mobile device. The primary outcome was caregiver-reported problem-solving skills. The noninferiority margin was defined as 0.2 standard deviation units of the change from baseline to end of intervention. Secondary outcomes included caregiver-reported mood disturbance, depression, and posttraumatic stress symptoms. The study was registered with ClinicalTrials.gov Identifier: NCT01711944.
Findings


The effect of the standard treatment was preserved; parents in the standard BI arm improved their problem-solving (effect size = 0.53,  t  = 8.88,  p  < .001). Parents in the web-based BI group also improved their problem-solving (effect size = 0.32,  t  = 5.32,  p  < .001). Although the web-based intervention preserved 60% of the standard treatment effect, the test of noninferiority was non-significant (effect size = -0.21,  p  = 0.55). Similarly, the web-based intervention preserved > 60% of the standard intervention effect on all secondary outcomes; however, tests of noninferiority were non-significant.
Interpretation


Noninferiority of web-based BI relative to standard face-to-face administration was not established. Further development of the web-based BI is needed before it can be recommended as a stand-alone intervention. However, the documented benefits of the web-based intervention as well as the advantages of low resource utilization and ease of delivery suggest that further development of web-based BI is indicated, and that it may play a valuable role in alleviating distress in caregivers of children with serious or chronic illness.
Funding


National Institutes of Health (U.S.), R01 CA159013 (P.I. Sahler).",2020,"Parents in the web-based BI group also improved their problem-solving (effect size = 0.32,  t  = 5.32,  p  < .001).","['parents of children with cancer', 'caregivers of children with serious or chronic illness', '621 caregivers of children with newly diagnosed cancer']","['standard BI delivered face-to-face or a web-based version delivered via mobile device', 'problem-solving skills intervention', '\n\n\nBright IDEAS (BI) problem-solving skills training']","['problem-solving', 'caregiver-reported mood disturbance, depression, and posttraumatic stress symptoms', 'caregiver-reported problem-solving skills']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",621.0,0.176933,"Parents in the web-based BI group also improved their problem-solving (effect size = 0.32,  t  = 5.32,  p  < .001).","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Psychology, St. Jude children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105-3678, United States.""}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Colorado School of Public Health, Aurora, CO, United States.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Noll', 'Affiliation': 'University of Pittsburgh, School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dolgin', 'Affiliation': 'Ariel University, Ariel, Israel.'}, {'ForeName': 'Sasja A', 'Initials': 'SA', 'LastName': 'Schepers', 'Affiliation': ""Department of Psychology, St. Jude children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105-3678, United States.""}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Askins', 'Affiliation': 'UT/MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Schneider', 'Affiliation': ""Baylor College of Medicine/Texas Children's Hospital, Houston, TX, United States.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Ingman', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Voll', 'Affiliation': 'University of Pittsburgh, School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Ernest R', 'Initials': 'ER', 'LastName': 'Katz', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'McLaughlin', 'Affiliation': 'Radiant Digital, Corporation, Vienna, VA, United States.'}, {'ForeName': 'Olle Jane Z', 'Initials': 'OJZ', 'LastName': 'Sahler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100428']
2148,32637918,Effects of Single-Task Versus Dual-Task Training on Balance Performance in Elderly Patients With Knee Osteoarthritis.,"Objectives


This study aims to compare the effects of single-task and dual-task training on balance performance in elderly patients with knee osteoarthritis (OA).
Patients and methods


Fifty elderly osteoarthritic patients with balance impairment (16 males, 34 females; mean age 72.9±5.5 years; range 65 to 84 years) were included in this study. Patients were randomly assigned to single-task balance training (group 1) or dual-task balance training (group 2) groups. Balance activities were given to both groups for three times a week for four weeks. Patients in group 2 also performed cognitive tasks simultaneously with these exercises. Patients were evaluated with Berg balance scale (BBS), kinesthetic ability trainer static and dynamic scores, timed up and go (TUG) test and walking speed (WS) for single and dual tasks, number of stopping and activities-specific balance confidence (ABC) scale at baseline and at the end of four weeks.
Results


At the end of the therapy, there were statistically significant improvements in BBS, KAT 2000 static and dynamic scores, TUG test and WS for single and dual tasks, number of stopping and ABC scale in both groups (p<0.05). But there was no statistical difference in any parameter between the groups (p>0.05).
Conclusion


Both single- and dual-task trainings are effective in improving balance performance under single- and dual-task conditions in elderly patients with knee OA. Dual-task training is not superior to single-task training for balance improvement in elderly osteoarthritic patients.",2020,Both single- and dual-task trainings are effective in improving balance performance under single- and dual-task conditions in elderly patients with knee OA.,"['Patients and methods\n\n\nFifty elderly osteoarthritic patients with balance impairment (16 males, 34 females; mean age 72.9±5.5 years', 'elderly patients with knee OA', ' range 65 to 84 years', 'elderly osteoarthritic patients', 'Elderly Patients With Knee Osteoarthritis', 'elderly patients with knee osteoarthritis (OA']","['Single-Task Versus Dual-Task Training', 'single-task balance training (group 1) or dual-task balance training', 'single-task and dual-task training', 'single- and dual-task trainings', 'Dual-task training']","['balance performance', 'Balance Performance', 'Balance activities', 'BBS, KAT 2000 static and dynamic scores, TUG test and WS for single and dual tasks, number of stopping and ABC scale', 'Berg balance scale (BBS), kinesthetic ability trainer static and dynamic scores, timed up and go (TUG) test and walking speed (WS) for single and dual tasks, number of stopping and activities-specific balance confidence (ABC) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0241981', 'cui_str': 'Impairment of balance'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0017453', 'cui_str': 'Georgian language'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.0132584,Both single- and dual-task trainings are effective in improving balance performance under single- and dual-task conditions in elderly patients with knee OA.,"[{'ForeName': 'Aslıhan', 'Initials': 'A', 'LastName': 'UzunkulaoĞlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ufuk University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Kerİm', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ufuk University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Saime', 'Initials': 'S', 'LastName': 'Ay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ufuk University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Süreyya', 'Initials': 'S', 'LastName': 'Ergİn', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Fizyocare Physical Medicine and Rehabilitation Center, Ankara, Turkey.'}]",Archives of rheumatology,['10.5606/ArchRheumatol.2020.7174']
2149,32637921,Short-term Efficacy Comparison of High-intensity and Low-intensity Laser Therapy in the Treatment of Lateral Epicondylitis: A Randomized Double-blind Clinical Study.,"Objectives


This study aims to evaluate and compare the short-term efficacies of high-intensity laser therapy (HILT) and low-intensity laser therapy (LILT) in the treatment of lateral epicondylitis (LE).
Patients and methods


Sixty patients (16 males, 44 females; mean age 44.2±9.3 years; range, 18 to 65 years) with unilateral elbow pain were randomized into two groups as 30 patients treated with HILT (9 males and 21 females) and 30 patients treated with LILT (7 males and 23 females). The HILT (1,064 nm) and LILT (904 nm) were administered three times a week for three weeks, and each treatment was combined with an epicondylitis bandage. A visual analog scale (VAS), quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire, Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36), and hand grip strength test were used to evaluate the patients before and three weeks after treatment.
Results


The two groups had similar demographic characteristics, including age, sex, occupation, and body mass index (p>0.05). There were no statistically significant differences between the two groups in terms of the pretreatment VAS, QDASH, hand grip strength, and SF-36 scores (p>0.05). After three weeks, both groups showed significant improvements in all of the parameters (p<0.05). However, in the HILT group, the QDASH, hand grip strength, and SF-36 physical component summary (PCS) scores showed superior improvement compared to the LILT group (p<0.05).
Conclusion


Each treatment modality was found to be effective and safe for the short-term treatment of LE. However, the HILT exhibited more significant effects on the hand grip strength, QDASH, and SF-36 PCS scores than the LILT.",2020,"There were no statistically significant differences between the two groups in terms of the pretreatment VAS, QDASH, hand grip strength, and SF-36 scores (p>0.05).","['lateral epicondylitis (LE', 'Lateral Epicondylitis', '9 males and 21 females) and 30 patients treated with LILT (7 males and 23 females', 'Patients and methods\n\n\nSixty patients (16 males, 44 females; mean age 44.2±9.3 years; range, 18 to 65 years) with unilateral elbow pain']","['High-intensity and Low-intensity Laser Therapy', 'HILT', 'epicondylitis bandage', 'LILT', 'high-intensity laser therapy (HILT) and low-intensity laser therapy (LILT']","['effective and safe', 'hand grip strength, QDASH, and SF-36 PCS scores', 'QDASH, hand grip strength, and SF-36 physical component summary (PCS) scores', 'A visual analog scale (VAS), quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire, Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36), and hand grip strength test', 'pretreatment VAS, QDASH, hand grip strength, and SF-36 scores']","[{'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3873737', 'cui_str': 'Low-intensity laser'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0239266', 'cui_str': 'Pain in elbow'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C3873737', 'cui_str': 'Low-intensity laser'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0014488', 'cui_str': 'Epicondylitis'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0359729,"There were no statistically significant differences between the two groups in terms of the pretreatment VAS, QDASH, hand grip strength, and SF-36 scores (p>0.05).","[{'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Kaydok', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Niğde Ömer Halisdemir University Faculty of Medicine, Niğde, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Ordahan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Necmettin Erbakan University Faculty of Meram Medicine, Konya, Turkey.'}, {'ForeName': 'Sezin', 'Initials': 'S', 'LastName': 'Solum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Niğde Bor Physical Medicine and Rehabilitation Training and Research Hospital, Niğde, Turkey.'}, {'ForeName': 'Ali Yavuz', 'Initials': 'AY', 'LastName': 'Karahan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Uşak University Faculty of Medicine, Uşak, Turkey.'}]",Archives of rheumatology,['10.5606/ArchRheumatol.2020.7347']
2150,32637923,"High-Energy Flux Density Extracorporeal Shock Wave Therapy Versus Traditional Physical Therapy Modalities in Myofascial Pain Syndrome: A Randomized-controlled, Single-Blind Trial.","Objectives


This study aims to investigate the effects of extracorporeal shock wave therapy (ESWT) on pain, sleep, fatigue, disability, depression, and quality of life (QoL) in patients with myofascial pain syndrome (MPS).
Patients and methods


Between March 2018 and September 2018, a total of 94 patients (16 males, 78 females; mean age 44.2±11.94 years; range, 19 to 74 years) with the diagnosis of MPS were included in the study. The patients were divided into two groups. The treatment group consisted of 49 patients and a total of seven sessions of high-energy flux density ESWT (H-ESWT) (0.26 mJ/mm2) were given with three days interval. The control group consisted of 45 patients and the treatment of hot pack, transcutaneous electrical nerve stimulation, and ultrasound was given for five days for two weeks. At baseline and one month after treatment, the visual analog scale (VAS), Short Form-36 (SF-36), Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, Neck Disability Index (NDI), and Beck Depression Inventory (BDI) scores were compared between the groups.
Results


There were no statistically significant differences in the age, sex, demographic characteristics, and baseline VAS, SF-36, NDI, BDI, FACIT, and PSQI scores between the groups (p>0.05). In the ESWT group, there was a statistically significant decrease in the VAS, SF-36, NDI, BDI, FACIT, and PSQI scores after treatment compared to the baseline scores, while only the SF-36 subscale scores were statistically significantly higher (p<0.05). There was a statistically significant correlation between the VAS and SF-36 scores and the BDI, NDI, FACIT and PSQI scores after the treatment.
Conclusion


Our study results suggest that H-ESWT is more effective than traditional physical therapy methods on pain, QoL, sleep, fatigue, depression, and disability in patients with MPS.",2020,"There was a statistically significant correlation between the VAS and SF-36 scores and the BDI, NDI, FACIT and PSQI scores after the treatment.
","['patients with myofascial pain syndrome (MPS', 'patients with MPS', 'Myofascial Pain Syndrome', 'Patients and methods\n\n\nBetween March 2018 and September 2018, a total of 94 patients (16 males, 78 females; mean age 44.2±11.94 years; range, 19 to 74 years) with the diagnosis of MPS were included in the study']","['hot pack, transcutaneous electrical nerve stimulation, and ultrasound', 'extracorporeal shock wave therapy (ESWT', 'High-Energy Flux Density Extracorporeal Shock Wave Therapy Versus Traditional Physical Therapy Modalities', 'H-ESWT']","['visual analog scale (VAS), Short Form-36 (SF-36), Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, Neck Disability Index (NDI), and Beck Depression Inventory (BDI) scores', 'VAS, SF-36, NDI, BDI, FACIT, and PSQI scores', 'pain, sleep, fatigue, disability, depression, and quality of life (QoL', 'pain, QoL, sleep, fatigue, depression, and disability', 'age, sex, demographic characteristics, and baseline VAS, SF-36, NDI, BDI, FACIT, and PSQI scores', 'VAS and SF-36 scores and the BDI, NDI, FACIT and PSQI scores', 'SF-36 subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",49.0,0.0310984,"There was a statistically significant correlation between the VAS and SF-36 scores and the BDI, NDI, FACIT and PSQI scores after the treatment.
","[{'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Gezgİnaslan', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, University of Health Sciences Ümraniye Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'GÜmÜŞ Atalay', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, University of Health Sciences Ümraniye Training and Research Hospital, İstanbul, Turkey.'}]",Archives of rheumatology,['10.5606/ArchRheumatol.2020.7496']
2151,32637925,Assessment of the Clinical Effects of Aquatic-based Exercises in the Treatment of Children With Juvenile Dermatomyositis: A 2x2 Controlled-Crossover Trial.,"Objectives


This study aims to compare the effect of aquatic-based exercises (AQBEs) and land-based exercises (LBEs) on muscle strength, fatigue and quality of life (QoL), and skin disease activity in children with juvenile dermatomyositis (JDM).
Patients and methods


The design of the study was an assessor-blinded, controlled 2x2 crossover trial. Fourteen children (4 boys, 10 girls; mean age 11.7±2.2 years; range, 10 to 16 years) were evaluated. AQBEs and LBEs were applied through two treatment sequences as half of the children received AQBEs first while the second half received LBEs first. Isometric muscle strength, fatigue level and QoL (Pediatric Quality of Life Inventory Multidimensional Fatigue Scale [PedsQL-MFS]), and skin disease activity score (DASskin) were measured at four occasions for each treatment sequence.
Results


The AQBEs had significant superiority over LBEs with improved hip flexors' strength (p=0.007) and hip abductors' strength (p=0.001), while both types of treatment had the same effect in increasing strength of shoulder flexors and abductors (p<0.05). AQBEs improved PedsQL-MFS, and DASskin significantly more than LBEs (p<0.001). For all outcome measures, there was no significant difference in the treatment sequence the children received first.
Conclusion


Supervised AQBEs are more effective in improving muscle strength, fatigue and QoL, and skin disease activity than LBEs in children with JDM. Furthermore, the treatment sequence had no significant effect on measured variables.",2020,"The AQBEs had significant superiority over LBEs with improved hip flexors' strength (p=0.007) and hip abductors' strength (p=0.001), while both types of treatment had the same effect in increasing strength of shoulder flexors and abductors (p<0.05).","['children with JDM', 'children with juvenile dermatomyositis (JDM', 'Children With Juvenile Dermatomyositis', 'Fourteen children (4 boys, 10 girls; mean age 11.7±2.2 years; range, 10 to 16 years']","['aquatic-based exercises (AQBEs) and land-based exercises (LBEs', 'Aquatic-based Exercises']","[""hip flexors' strength"", 'AQBEs and LBEs', 'strength of shoulder flexors and abductors (p<0.05', 'AQBEs improved PedsQL-MFS, and DASskin', ""hip abductors' strength"", 'muscle strength, fatigue and QoL, and skin disease activity', 'muscle strength, fatigue and quality of life (QoL), and skin disease activity', 'Isometric muscle strength, fatigue level and QoL (Pediatric Quality of Life Inventory Multidimensional Fatigue Scale [PedsQL-MFS]), and skin disease activity score (DASskin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0263666', 'cui_str': 'Childhood type dermatomyositis'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",14.0,0.0361809,"The AQBEs had significant superiority over LBEs with improved hip flexors' strength (p=0.007) and hip abductors' strength (p=0.001), while both types of treatment had the same effect in increasing strength of shoulder flexors and abductors (p<0.05).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samhan', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nermeen', 'Initials': 'N', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ragab', 'Initials': 'R', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Archives of rheumatology,['10.5606/ArchRheumatol.2020.7548']
2152,32638017,"Randomized controlled Phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC).","Gastrectomy with omentectomy and D2 lymph node dissection is the current standard procedure for locally advanced gastric cancer. However, some retrospective studies have reported that omentectomy increased post-operative abdominal complications but provided no survival advantage over omentum preservation. Therefore, we plan a randomized controlled phase III trial to confirm the non-inferiority of omentum preservation compared with omentectomy in patients with cT3 (SS) or cT4a (SE) gastric cancer. A total of 1050 patients will be enrolled from 62 institutions over a period of 6.5 years. The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000036253.",2020,"The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events.","['patients with advanced gastric cancer (JCOG1711, ROAD-GC', 'locally advanced gastric cancer', '1050 patients will be enrolled from 62 institutions over a period of 6.5\xa0years', 'patients with cT3 (SS) or cT4a (SE) gastric cancer']","['omentum preserving gastrectomy', 'Gastrectomy with omentectomy and D2 lymph node dissection']","['relapse-free survival', 'overall survival, blood loss, operation time and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}]","[{'cui': 'C0028977', 'cui_str': 'Omental'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0198614', 'cui_str': 'Omentectomy'}, {'cui': 'C2960517', 'cui_str': 'D2 lymph node dissection'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1050.0,0.162456,"The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events.","[{'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Gastric Surgery Division, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa113']
2153,32638031,[Sucrose octasulfate-evidence in the treatment of chronic wounds].,"Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area. One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate. For wound products containing TLC-sucrose octasulfate, several sequential clinical studies have been conducted in recent years. The WHAT study was an open randomized controlled trial (RCT) with 117 patients with venous leg ulcers (VLU). The CHALLENGE study was a double-blind RCT with 187 patients with VLU. The SPID study was a pilot study with 33 patients with diabetic foot ulcers (DFU). The two prospective, multicenter clinical pilot studies NEREIDES and CASSIOPEE examined a total of 88 patients with VLU in different phases of healing. In the REALITY study, a pooled data analysis was performed on eight observational studies with 10,220 patients with chronic wounds of different genesis. In the double-blind, two-armed EXPLORER RCT, 240 patients with neuro-ischemic DFU were followed from first presentation until complete healing. In all studies, a significant promotion of wound healing could be shown by the use of wound healing products with TLC-sucrose octasulfate.",2020,"One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate.","['10,220 patients with chronic wounds of different genesis', 'chronic wounds', '240 patients with neuro-ischemic DFU', '88\xa0patients with VLU in different phases of healing', '187 patients with VLU', '33\xa0patients with diabetic foot ulcers (DFU', 'Patients with chronic wounds', '117 patients with venous leg ulcers (VLU']",['TLC-sucrose octasulfate (TLC: technology lipido-colloid'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C4255166', 'cui_str': 'Genesis'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0473559', 'cui_str': 'Ischemic ulcer diabetic foot'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0075479', 'cui_str': 'sucrose octasulfate'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}]",[],240.0,0.0518699,"One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate.","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dissemond', 'Affiliation': 'Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstr.\xa055, 45147, Essen, Deutschland. joachim.dissemond@uk-essen.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Diabetesschwerpunktpraxis Dietlein, Bauernstr.\xa050, 86391, Stadtbergen, Deutschland.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Keuthage', 'Affiliation': 'Schwerpunktpraxis Diabetes und Ernährungsmedizin, MedicalCenter am Clemenshospital, Düesbergweg\xa0128, 48153, Münster, Deutschland.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Läuchli', 'Affiliation': 'Dermatologische Klinik, Universitätsspital Zürich, Gloriastr.\xa031, 8091, Zürich, Schweiz.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lobmann', 'Affiliation': 'Klinik für Endokrinologie, Diabetologie und Geriatrie, Klinikum Stuttgart - Krankenhaus Bad Cannstatt, Prießnitzweg\xa024, 70374, Stuttgart, Deutschland.'}, {'ForeName': 'Karl-Christian', 'Initials': 'KC', 'LastName': 'Münter', 'Affiliation': 'Gemeinschaftspraxis Bramfeld, Bramfelder Chaussee\xa0200, 22177, Hamburg, Deutschland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stücker', 'Affiliation': 'Abteilung für Dermatologie und Venerologie, LKH Feldkirch, Akademisches Lehrspital, Carinagasse 45-47, 6800, Feldkirch, Österreich.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Traber', 'Affiliation': 'Abteilung für Dermatologie Venerologie und Allergologie am St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Gudrunstr.\xa056, 44791, Bochum, Deutschland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Vanscheidt', 'Affiliation': 'Venenklinik Bellevue, Brückenstr.\xa09, 8280, Kreuzlingen, Schweiz.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strohal', 'Affiliation': 'Dermatologische Gemeinschaftspraxis, Paula-Modersohn-Platz\xa03, 79100, Freiburg, Deutschland.'}]","Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete",['10.1007/s00105-020-04637-9']
2154,32638035,"The effects of acute serotonin challenge on executive planning in patients with obsessive-compulsive disorder (OCD), their first-degree relatives, and healthy controls.","RATIONALE


Obsessive-compulsive disorder (OCD) is characterized by executive function impairment and by clinical responsivity to selective serotonin reuptake inhibitors (SSRIs). Executive planning deficits constitute a candidate endophenotype for OCD. It is not known whether this endophenotype is responsive to acute serotonin manipulation.
OBJECTIVE


The study aimed to investigate the effects of acute SSRI administration on executive function in patients with OCD, first-degree relatives of patients with OCD, and healthy controls.
METHODS


A randomized double-blind cross-over study assessed the effects of single-dose escitalopram (20 mg) and placebo on executive planning in 24 patients with OCD, 13 clinically unaffected first-degree relatives of patients with OCD, and 28 healthy controls. Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
RESULTS


On the outcome measure of interest, i.e., the mean number of choices to obtain the correct solution, there was a marginally significant effect of group (F(2, 59) = 3.1; p = 0.052), with patients (least square (LS) mean 1.43; standard error [SE] 0.06; 95% confidence interval (CI), 1.31-1.55) and their relatives (LS mean 1.46; SE 0.08; 95% CI, 1.30-1.62) performing worse than matched healthy controls (LS mean 1.26; SE 0.05; 95% CI, 1.15-1.37) on placebo. There was a trend towards a significant group × treatment interaction (F(2, 58) = 2.8, p = 0.069), with post hoc tests showing (i) patients (p = 0.009; LS mean difference 0.23; SE 0.08) and relatives (p = 0.03; LS mean difference 0.22; SE 0.10) were more impaired compared to controls and (ii) escitalopram was associated with improved executive planning in patients with OCD (p = 0.013; LS mean difference 0.1; SE 0.04), but not other groups (both p > 0.1; controls: LS mean difference - 0.03; SE 0.04; relatives: LS mean difference 0.02; SE 0.05).
CONCLUSION


Our findings are consistent with a view that there is impaired executive planning in OCD and that this constitutes a behavioural endophenotype. In patients with OCD, but not in relatives, acute SSRI administration ameliorated this deficit. Further investigation is needed to understand common and differential involvement of neurochemical systems in patients with OCD and their relatives.",2020,"Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
","['patients with obsessive-compulsive disorder (OCD), their first-degree relatives, and healthy controls', 'Obsessive-compulsive disorder (OCD', 'patients with OCD and their relatives', 'patients with OCD, first-degree relatives of patients with OCD, and healthy controls', '24 patients with OCD, 13 clinically unaffected first-degree relatives of patients with OCD, and 28 healthy controls']","['acute serotonin challenge', 'acute SSRI administration', 'single-dose escitalopram (20\xa0mg) and placebo', 'placebo']","['executive planning', 'executive function', 'mean number of choices to obtain the correct solution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",24.0,0.0857476,"Performance on a Tower of London task measuring executive planning was assessed 4 h after oral administration of the pharmacological challenge/placebo and compared across and within groups using a mixed model analysis of variance.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lochner', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry, Stellenbosch University, Stellenbosch, South Africa. cl2@sun.ac.za.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kidd', 'Affiliation': 'Centre for Statistical Consultation, Department of Statistics and Actuarial Sciences, University of Stellenbosch, Stellenbosch, South Africa.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Taljaard', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'National Treatment Service for OCD, Hertfordshire, UK.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk & Resilience in Mental Disorders, Department of Psychiatry & Neuroscience Institute, University of Cape Town, Cape Town, South Africa.'}]",Psychopharmacology,['10.1007/s00213-020-05597-7']
2155,32638063,Electroacupuncture for balanced mixed urinary incontinence: secondary analysis of a randomized non-inferiority controlled trial.,"INTRODUCTION AND HYPOTHESIS


The aim was to investigate the effectiveness and safety of electroacupuncture (EA) in women with balanced mixed urinary incontinence (MUI) compared with PFMT plus solifenacin.
METHODS


This is a secondary analysis of a randomized non-inferiority clinical trial. Seventy-nine patients with balanced MUI were randomly assigned to receive either 12-week EA with 24-week follow-up or 36-week PFMT and solifenacin. Primary outcome was the proportion of participants with ≥50% reduction of mean 24-h incontinence episode frequency (IFE) through weeks 1-12 from baseline. Analysis was performed in an intention-to-treat population using a generalized linear model with a binomial distribution, adjusted for imbalances in baseline variables, and a two-sided p value of less than 0.05 was considered significant.
RESULTS


A total of 34 participants in the EA group and 45 participants in the PFMT plus solifenacin group were included in the intention-to-treat analysis of primary outcome. Through weeks 1-12, the proportion of participants with ≥50% reduction of mean 24-h IEF was 32.4% in the EA group, and 37.2% in the PFMT plus solifenacin group, with a mean difference of -2.82% (95%CI: -23.88 to 18.23, p=0.79), revealing non-inferiority. No significant difference held true for all the secondary outcomes. Six adverse events occurred in the EA group and 22 in the PEMT plus solifenacin group.
CONCLUSIONS


The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety. The effects of EA may sustain 24 weeks after treatment.",2020,The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety.,"['34 participants in the EA group and 45 participants in the', 'women with balanced mixed urinary incontinence (MUI', 'balanced mixed urinary incontinence', 'Seventy-nine patients with balanced MUI']","['electroacupuncture (EA', 'EA with 24-week follow-up or 36-week PFMT and solifenacin', 'PFMT plus solifenacin', 'Electroacupuncture', 'EA']","['mean 24-h IEF', 'proportion of participants with ≥50% reduction of mean 24-h incontinence episode frequency (IFE', 'Six adverse events']","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",79.0,0.301899,The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Acupuncture and Moxibustion College, Hubei University of Chinese Medicine, Wuhan, 430061, China.'}, {'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an, 710003, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Fengxia', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Acupuncture and Moxibustion College, Hubei University of Chinese Medicine, Wuhan, 430061, China. 315938821@qq.com.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. zhishunjournal@163.com.""}]",International urogynecology journal,['10.1007/s00192-020-04305-5']
2156,32632956,Interventions for mycosis fungoides.,"BACKGROUND


Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma, a malignant, chronic disease initially affecting the skin. Several therapies are available, which may induce clinical remission for a time. This is an update of a Cochrane Review first published in 2012: we wanted to assess new trials, some of which investigated new interventions.
OBJECTIVES


To assess the effects of interventions for MF in all stages of the disease.
SEARCH METHODS


We updated our searches of the following databases to May 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched 2 trials registries for additional references. For adverse event outcomes, we undertook separate searches in MEDLINE in April, July and November 2017.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of local or systemic interventions for MF in adults with any stage of the disease compared with either another local or systemic intervention or with placebo.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcomes were improvement in health-related quality of life as defined by participants, and common adverse effects of the treatments. Key secondary outcomes were complete response (CR), defined as complete disappearance of all clinical evidence of disease, and objective response rate (ORR), defined as proportion of patients with a partial or complete response. We used GRADE to assess the certainty of evidence and considered comparisons of psoralen plus ultraviolet A (PUVA) light treatment as most important because this is first-line treatment for MF in most guidelines.
MAIN RESULTS


This review includes 20 RCTs (1369 participants) covering a wide range of interventions. The following were assessed as either treatments or comparators: imiquimod, peldesine, hypericin, mechlorethamine, nitrogen mustard and intralesional injections of interferon-α (IFN-α) (topical applications); PUVA, extracorporeal photopheresis (ECP: photochemotherapy), and visible light (light applications); acitretin, bexarotene, lenalidomide, methotrexate and vorinostat (oral agents); brentuximab vedotin; denileukin diftitox; mogamulizumab; chemotherapy with cyclophosphamide, doxorubicin, etoposide, and vincristine; a combination of chemotherapy with electron beam radiation; subcutaneous injection of IFN-α; and intramuscular injections of active transfer factor (parenteral systemics). Thirteen trials used an active comparator, five were placebo-controlled, and two compared an active operator to observation only. In 14 trials, participants had MF in clinical stages IA to IIB. All participants were treated in secondary and tertiary care settings, mainly in Europe, North America or Australia. Trials recruited both men and women, with more male participants overall. Trial duration varied from four weeks to 12 months, with one longer-term study lasting more than six years. We judged 16 trials as at high risk of bias in at least one domain, most commonly performance bias (blinding of participants and investigators), attrition bias and reporting bias. None of our key comparisons measured quality of life, and the two studies that did presented no usable data. Eighteen studies reported common adverse effects of the treatments. Adverse effects ranged from mild symptoms to lethal complications depending upon the treatment type. More aggressive treatments like systemic chemotherapy generally resulted in more severe adverse effects. In the included studies, CR rates ranged from 0% to 83% (median 31%), and ORR ranged from 0% to 88% (median 47%). Five trials assessed PUVA treatment, alone or combined, summarised below. There may be little to no difference between intralesional IFN-α and PUVA compared with PUVA alone for 24 to 52 weeks in CR (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.87 to 1.31; 2 trials; 122 participants; low-certainty evidence). Common adverse events and ORR were not measured. One small cross-over trial found once-monthly ECP for six months may be less effective than twice-weekly PUVA for three months, reporting CR in two of eight participants and ORR in six of eight participants after PUVA, compared with no CR or ORR after ECP (very low-certainty evidence). Some participants reported mild nausea after PUVA but no numerical data were given. One participant in the ECP group withdrew due to hypotension. However, we are unsure of the results due to very low-certainty evidence. One trial comparing bexarotene plus PUVA versus PUVA alone for up to 16 weeks reported one case of photosensitivity in the bexarotene plus PUVA group compared to none in the PUVA-alone group (87 participants; low-certainty evidence). There may be little to no difference between bexarotene plus PUVA and PUVA alone in CR (RR 1.41, 95% CI 0.71 to 2.80) and ORR (RR 0.94, 95% CI 0.61 to 1.44) (93 participants; low-certainty evidence). One trial comparing subcutaneous IFN-α injections combined with either acitretin or PUVA for up to 48 weeks or until CR indicated there may be little to no difference in the common IFN-α adverse effect of flu-like symptoms (RR 1.32, 95% CI 0.92 to 1.88; 82 participants). There may be lower CR with IFN-α and acitretin compared with IFN-α and PUVA (RR 0.54, 95% CI 0.35 to 0.84; 82 participants) (both outcomes: low-certainty evidence). This trial did not measure ORR. One trial comparing PUVA maintenance treatment to no maintenance treatment, in participants who had already had CR, did report common adverse effects. However, the distribution was not evaluable. CR and OR were not assessable. The range of treatment options meant that rare adverse effects consequently occurred in a variety of organs.
AUTHORS' CONCLUSIONS


​​There is a lack of high-certainty evidence to support decision making in the treatment of MF. Because of substantial heterogeneity in design, missing data, small sample sizes, and low methodological quality, the comparative safety and efficacy of these interventions cannot be reliably established on the basis of the included RCTs. PUVA is commonly recommended as first-line treatment for MF, and we did not find evidence to challenge this recommendation. There was an absence of evidence to support the use of intralesional IFN-α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF. Future trials should compare the safety and efficacy of treatments to PUVA, as the current standard of care, and should measure quality of life and common adverse effects.",2020,There was an absence of evidence to support the use of intralesional IFN-α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF.,"['2012', 'mycosis fungoides', 'adults with any stage of the disease compared with either another local or systemic intervention or with', 'Mycosis fungoides (MF', 'Trials recruited both men and women, with more male participants overall', 'All participants were treated in secondary and tertiary care settings, mainly in Europe, North America or Australia', '20 RCTs (1369 participants) covering a wide range of interventions']","['PUVA', 'IFN-α and PUVA', 'imiquimod, peldesine, hypericin, mechlorethamine, nitrogen mustard and intralesional injections of interferon-α (IFN-α) (topical applications); PUVA, extracorporeal photopheresis (ECP: photochemotherapy), and visible light (light applications); acitretin, bexarotene, lenalidomide, methotrexate and vorinostat (oral agents', 'bexarotene', 'IFN-α', 'subcutaneous IFN-α injections combined with either acitretin or PUVA', 'cyclophosphamide, doxorubicin, etoposide, and vincristine', 'bexarotene plus PUVA', 'active transfer factor (parenteral systemics', 'ECP', 'psoralen plus ultraviolet A (PUVA) light treatment', 'placebo']","['quality of life', 'CR rates', 'health-related quality of life', 'ORR', 'mild nausea', 'severe adverse effects', 'common IFN-α adverse effect of flu-like symptoms', 'complete response (CR), defined as complete disappearance of all clinical evidence of disease, and objective response rate (ORR), defined as proportion of patients with a partial or complete response']","[{'cui': 'C0026948', 'cui_str': 'Mycosis fungoides'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0338278', 'cui_str': 'peldesine'}, {'cui': 'C0063220', 'cui_str': 'hypericin'}, {'cui': 'C0025033', 'cui_str': 'Mechlorethamine'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0206373', 'cui_str': 'Extracorporeal photopheresis'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0242377', 'cui_str': 'Visible light'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0050559', 'cui_str': 'Acitretin'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040673', 'cui_str': 'Transfer Factor'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0016072', 'cui_str': 'Ficusin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",,0.46717,There was an absence of evidence to support the use of intralesional IFN-α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF.,"[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Johann Wolfgang Goethe-University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Johann Wolfgang Goethe-University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'Center for Evidence-Based Healthcare, Faculty of Medicine Carl Gustav Carus, Technischen Universität (TU) Dresden, Dresden, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bunch', 'Affiliation': 'c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Weberschock', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Johann Wolfgang Goethe-University Hospital, Frankfurt am Main, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008946.pub3']
2157,32632986,Effects of phosphodiesterase-5 inhibitor sildenafil on esophageal secondary peristalsis: studies with high-resolution manometry.,"BACKGROUND AND AIM


Secondary peristalsis contributes to the clearance of retained refluxate from the esophagus. Sildenafil, a phosphodiesterase-5 inhibitor, inhibits primary esophageal peristalsis, but its effects on secondary peristalsis remain unknown. This study sought to investigate whether sildenafil could influence physiological characteristics of secondary peristalsis by applying high-resolution manometry (HRM).
METHODS


Seventeen healthy volunteers (15 men and 2 women, aged 30.2 ± 6.4 years) underwent two HRM studies on separate days following the administration of either a placebo or 50 mg of sildenafil in a random order. Both studies were performed using a water-perfused HRM catheter containing one air-injection channel positioned in the mid-esophagus. Secondary peristalsis was stimulated by a rapid mid-esophageal injection of 10 mL or 20 mL of air one hour after the administration of either the placebo or sildenafil. The frequency and distal contractile integral of secondary peristalsis were then compared.
RESULTS


Complete secondary peristalsis triggered by the 20-mL air injection was more frequent than observed with the 10-mL air injection (P < 0.001). The vigor of secondary peristalsis triggered by the injection of either volume of air was lower than that of primary peristalsis (P < 0.001). Sildenafil significantly reduced the success rate (P ≤ 0.001) and vigor (P < 0.001) of secondary peristalsis relative to the effects of the placebo at both distension volumes.
CONCLUSIONS


Secondary peristalsis can be successfully triggered by rapid air injection during HRM. Sildenafil reduces both the success rate and vigor of secondary peristalsis, similar to as seen with primary peristalsis.",2020,"Sildenafil significantly reduced the success rate (P ≤ 0.001) and vigor (P < 0.001) of secondary peristalsis relative to the effects of the placebo at both distension volumes.
","['Seventeen healthy volunteers (15 men and 2 women, aged 30.2 ± 6.4 years']","['phosphodiesterase-5 inhibitor sildenafil', 'placebo', 'placebo or sildenafil', 'placebo or 50 mg of sildenafil', 'Sildenafil', 'sildenafil']","['20-mL air injection', 'success rate and vigor of secondary peristalsis', 'frequency and distal contractile integral of secondary peristalsis', 'success rate']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0184946', 'cui_str': 'Injection of air'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0443238', 'cui_str': 'Integral'}]",17.0,0.23457,"Sildenafil significantly reduced the success rate (P ≤ 0.001) and vigor (P < 0.001) of secondary peristalsis relative to the effects of the placebo at both distension volumes.
","[{'ForeName': 'Ming-Wun', 'Initials': 'MW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chih-Hsun', 'Initials': 'CH', 'LastName': 'Yi', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tso-Tsai', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Lei', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jui-Sheng', 'Initials': 'JS', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chao-Zong', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacology, School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15170']
2158,32633020,Randomized trial of bipolar resection vs. Holmium laser enucleation vs. Greenlight laser vapo-enucleation of the prostate for treatment of large sized benign prostate obstruction; 3-years outcome.,"PURPOSE


To assess the non-inferiority of transurethral resection in saline (TURis) and Greenlight laser Vapo-Enucleation of the prostate (GL.PVEP) to Holmium laser enucleation of the prostate (HoLEP) for controlling lower urinary tract symptoms secondary to large sized BPH with comparable 3-years-retreatment rate.
METHODS


Eligible patients with BPH (80-150ml) were randomly assigned to one of the intervention groups. Non-inferiority of retreatment rate was evaluated using a 1-sided test at 5% level of significance.
RESULTS


At time of analysis, 60 GL.PVEP, 60 HoLEP and 62 TURis procedures were included. Perioperative parameters were comparable between groups however; longer operative time (92+32, 73+30 and 83+28min, P=0.005) and less operative efficiency (1.2+0.4, 1.7+0.7 and 1.4+0.6gm/min, P=0.000) have been reported in GL.PVEP vs. HoLEP and TURis respectively. Perioperative complications and need for auxiliary procedures were similar in the three groups however significantly higher rate of capsular violation 5, 8% was reported in TURis group compared to 1, 1.6% in GL.PVEP and none in HoLEP, p=0.01. Significantly longer hospital-stay, catheter-time and higher rate of blood transfusion were reported following TURis. There was significant comparable improvement in IPSS in 3 groups at different follow-up points. At 3 years, retreatment for recurrent BOO was more after GL.PVEP and TURis. More redo surgeries for recurrent obstructing prostate adenoma was reported after GL.PVEP (4, 6.7%) and TURis (6, 9.7%) in comparison to HoLEP (none) (P=0.04).
CONCLUSION


The perioperative outcome of GL.PVEP and HoLEP surpasses that of TURIS for treatment of large sized prostate with significantly more operative time with GL.PVEP. The three techniques achieve good functional outcome however 3-years retreatment rate following TURIS and GL.PVEP was inferior to HoLEP.",2020,"Perioperative complications and need for auxiliary procedures were similar in the three groups however significantly higher rate of capsular violation 5, 8% was reported in TURis group compared to 1, 1.6% in GL.PVEP and none in HoLEP, p=0.01.",['Eligible patients with BPH (80-150ml'],"['transurethral resection in saline (TURis) and Greenlight laser Vapo-Enucleation of the prostate (GL.PVEP', 'Holmium laser enucleation of the prostate (HoLEP', 'TURIS and GL.PVEP', 'bipolar resection vs. Holmium laser enucleation vs. Greenlight laser vapo-enucleation', 'TURIS']","['Perioperative complications and need for auxiliary procedures', 'operative efficiency', 'Perioperative parameters', 'longer operative time', 'recurrent obstructing prostate adenoma', 'rate of capsular violation', 'hospital-stay, catheter-time and higher rate of blood transfusion', 'operative time', 'IPSS', 'recurrent BOO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0520477', 'cui_str': 'Benign adenoma of prostate'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}]",,0.0360491,"Perioperative complications and need for auxiliary procedures were similar in the three groups however significantly higher rate of capsular violation 5, 8% was reported in TURis group compared to 1, 1.6% in GL.PVEP and none in HoLEP, p=0.01.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Mansoura Urology and Nephrology Center, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Soltan', 'Affiliation': 'Mansoura Urology and Nephrology Center, Egypt.'}, {'ForeName': 'Nasr A', 'Initials': 'NA', 'LastName': 'El-Tabey', 'Affiliation': 'Mansoura Urology and Nephrology Center, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Mansoura Urology and Nephrology Center, Egypt.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Nabeeh', 'Affiliation': 'Mansoura Urology and Nephrology Center, Egypt.'}]",BJU international,['10.1111/bju.15161']
2159,32633040,The effect of a 2-mm inter-implant distance on esthetic outcomes in immediately non-occlusally loaded platform shifted implants in healed ridges: 12-month results of a randomized clinical trial.,"BACKGROUND


Three millimeter is considered as the minimum distance to obtain soft and bone tissue stability in case of adjacent implants. The possibility to preserve peri-implant bone level using a platform switching connection has questioned this concept.
PURPOSE


The study evaluates soft tissue maintenance and marginal bone stability around implants, placed at 2 or 3 mm of distance.
MATERIALS AND METHODS


Thirty patients received two immediately loaded implants either at 2-mm (test) or at 3-mm (control) of distance in the premolar area. Soft tissue esthetics (papilla height and fill, keratinized tissue, recession) and radiographic peri-implant bone level changes were measured at 3, 6, and 12 months.
RESULTS


No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
CONCLUSION


The results suggested that up to 12 months post-loading, both 2- and 3-mm inter-distance platform-switched implants in healed site, supported adequate esthetic outcomes and peri-implant bone stability.",2020,"No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
","['immediately non-occlusally loaded platform shifted implants in healed ridges', 'Thirty patients received two immediately loaded implants either at 2-mm (test) or at 3-mm (control) of distance in the premolar area']",['2-mm inter-implant distance'],"['bone level modifications', 'Soft tissue esthetics (papilla height and fill, keratinized tissue, recession) and radiographic peri-implant bone level changes', 'soft tissue esthetic outcomes', 'adequate esthetic outcomes and peri-implant bone stability', 'esthetic outcomes']","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",30.0,0.0544968,"No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Rivara', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Guido Maria', 'Initials': 'GM', 'LastName': 'Macaluso', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Toffoli', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calciolari', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Goldoni', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lumetti', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}]",Clinical implant dentistry and related research,['10.1111/cid.12926']
2160,32633141,Renal sympathetic denervation lowers systemic vascular resistance in true treatment-resistant hypertension.,"PURPOSE


Renal sympathetic denervation (RDN) is again gaining interest as recent well-designed trials have demonstrated reduced ambulatory blood pressure (BP) after RDN. However, the hemodynamic mechanisms have not been elucidated. We aimed for the first time to investigate the effect of RDN on the ""Hallmark of Hypertension"" namely increased systemic vascular resistance index (SVRI).
MATERIALS AND METHODS


We investigated SVRI change in patients with true treatment-resistant hypertension randomised to RDN ( n  = 9) or drug adjusted control ( n  = 9). Treatment-resistant hypertension was defined as office systolic BP ≥ 140 mmHg despite ≥ 3 antihypertensive drugs including a diuretic. True treatment-resistant hypertension was confirmed prior to inclusion with ambulatory daytime systolic BP ≥ 135 mmHg immediately after witnessed intake of antihypertensive drugs. Hemodynamic variables were recorded with thoracic impedance cardiography at baseline and at three and six months follow-up after RDN. This non-invasive method also guided further tailoring of drug treatment in the control group aiming to normalise hemodynamic variables and BP.
RESULTS


From three to six months follow-up after RDN, SVRI decreased with a median of -611 dyn*s*m 2 /cm 5  [IQR -949 to -267] ( p  < 0.01), while supine mean BP decreased with a median of -11 mmHg [IQR -21 to -3] ( p  = 0.02). In the same period, SVRI in the control group was reduced with -674 dyn*s*m 2 /cm 5  [IQR -1,309 to -340] ( p  < 0.01), while supine mean BP decreased with -15 mmHg [IQR -29 to -6] ( p  = 0.01). Thus, hemodynamic variables and BP in the two groups normalised in parallel.
CONCLUSION


Our data suggest that in patients with true treatment-resistant hypertension, renal sympathetic denervation lowers BP by reducing systemic vascular resistance of similar size as in the control group with careful individual selection of antihypertensive drugs and dose titration.",2020,"This non-invasive method also guided further tailoring of drug treatment in the control group aiming to normalise hemodynamic variables and BP.
","['patients with true treatment-resistant hypertension randomised to RDN ( n \u2009=\u20099) or drug adjusted control ( n \u2009=\u20099', 'patients with true treatment-resistant hypertension', 'true treatment-resistant hypertension']","['Renal sympathetic denervation', 'RDN']","['ambulatory blood pressure (BP', 'hemodynamic variables and BP', 'SVRI', 'systemic vascular resistance index (SVRI', 'supine mean BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}]","[{'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.0272586,"This non-invasive method also guided further tailoring of drug treatment in the control group aiming to normalise hemodynamic variables and BP.
","[{'ForeName': 'Kaja K', 'Initials': 'KK', 'LastName': 'Bergo', 'Affiliation': 'Institute for Experimental Medical Research, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Larstorp', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hoffmann', 'Affiliation': 'Section for Interventional Cardiology, Department of Cardiology, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Hjørnholm', 'Affiliation': 'Section of Cardiovascular and Renal Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cataliotti', 'Affiliation': 'Institute for Experimental Medical Research, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Aud', 'Initials': 'A', 'LastName': 'Høieggen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Rostrup', 'Affiliation': 'Section of Cardiovascular and Renal Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Fadl Elmula M', 'Initials': 'FEM', 'LastName': 'Fadl Elmula', 'Affiliation': 'Section of Cardiovascular and Renal Research, Oslo University Hospital, Oslo, Norway.'}]",Blood pressure,['10.1080/08037051.2020.1789446']
2161,32633151,An Eye Tracking Approach to Understanding Misinformation and Correction Strategies on Social Media: The Mediating Role of Attention and Credibility to Reduce HPV Vaccine Misperceptions.,"This study uses an unobtrusive eye tracking approach to examine understudied psychological mechanisms - message attention and credibility - when people are exposed to misinformation and correction on social media. We contrast humor versus non-humor correction strategies that point out rhetorical flaws in misinformation regarding the HPV vaccine, which was selected for its relevance and impact on public health. We randomly assigned participants to one of two experimental conditions: humor correction versus non-humor correction. Our analyses revealed that the humor correction increased attention to the image portion of the correction tweet, and this attention indirectly lowered HPV misperceptions by reducing the credibility of the misinformation tweet. The study also found that the non-humor correction outperformed the humor correction in reducing misperceptions via its higher credibility ratings. Practical implications for correcting misinformation on social media are discussed.",2020,"Our analyses revealed that the humor correction increased attention to the image portion of the correction tweet, and this attention indirectly lowered HPV misperceptions by reducing the credibility of the misinformation tweet.",['Social Media'],['humor correction versus non-humor correction'],[],"[{'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0020168', 'cui_str': 'Humor'}]",[],,0.0173641,"Our analyses revealed that the humor correction increased attention to the image portion of the correction tweet, and this attention indirectly lowered HPV misperceptions by reducing the credibility of the misinformation tweet.","[{'ForeName': 'Sojung Claire', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Department of Communication, George Mason University , Fairfax, Virginia, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Vraga', 'Affiliation': 'The Hubbard School of Journalism and Mass Communication, University of Minnesota , Minneapolis, Minnesota, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'The Center for Climate Change Communication at George Mason University , Fairfax, Virginia, USA.'}]",Health communication,['10.1080/10410236.2020.1787933']
2162,32633244,"Large study (283 women) on the effectiveness of Manosar®: 2 g of d-mannose + 140 mg of proanthocyanidins (PAC), of prolonged release.","OBJECTIVE


To compare the efficacy and safety in the prophylasis of urinary tract infections (UTIs) with a food supplement that contains D-mannose like active ingredient (Manosar®), in comparison to another preparation in which the active ingredient are the proanthocyanidins (PAC), both of them, in prolonged released, after, they was administered for 24 weeks.
METHODS


A multicenter, randomized and double blind experimental study was carried out. 283 women with a history of recurrent UTIs without evidence of complication were included. They were randomized 1: 1 in two groups. In one group, 1 oral sachet of Manosar® a day was administered, and in the other group 1 oral sachet of a compound of 240 mg of continuous-release PAC. Prior to inclusion in the study, the episode of UTI was confirmed at least by the clinical symptoms and positivity of the Combur test.
RESULTS


Valid data were obtained from 184 patients with an average age of 49.5 years: 90 received Manosar® and 94 isolated PAC. A total of 72 patients suffered an UTI due to E.coli: 25 patients in the arm with Manosar® versus 47 patients in the isolated PAC group, this difference being statistically significant (p=0.002). The free time of new UTI recurrences was 98.6 days in the group treated with Manosar® and 84.6 days in the group with isolated PAC.
CONCLUSION


The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.",2020,"The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.","['184 patients with an average age of 49.5 years: 90 received Manosar® and 94 isolated PAC', '283 women with a history of recurrent UTIs without evidence of complication were included', '72 patients suffered an UTI due to E.coli: 25 patients in the arm with Manosar® versus 47 patients in the isolated PAC group', 'Large study (283 women']","['Manosar®', 'food supplement that contains D-mannose like active ingredient (Manosar®', 'Manosar®: 2 g of d-mannose + 140 mg of proanthocyanidins (PAC']","['efficacy and safety', 'free time of new UTI recurrences']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3532611', 'cui_str': 'History of recurrent urinary tract infection'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",283.0,0.0578281,"The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salinas-Casado', 'Affiliation': 'Servicio de Urología. Hospital Clínico San Carlos. Madrid. España.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Méndez-Rubio', 'Affiliation': 'Servicio de Urología. Hospital Universitario Sanitas La Moraleja. Madrid. España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Esteban-Fuertes', 'Affiliation': 'Servicio de Urología. Hospital Nacional de Parapléjicos de Toledo. Toledo. España.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gómez-Rodríguez', 'Affiliation': 'Servicio de Urología. Complejo Hospitalario de Toledo. Toledo. España.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vírseda-Chamorro', 'Affiliation': 'Servicio de Urología. Hospital Nacional de Parapléjicos de Toledo. Toledo. España.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Luján-Galán', 'Affiliation': 'Servicio de Urología. Hospital Universitario Infanta Cristina. Parla. Madrid. España.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Iglesias-García', 'Affiliation': 'Clinical Partner & Innovation, S.L. Madrid. España.'}, {'ForeName': 'Grupo', 'Initials': 'G', 'LastName': 'Rituman', 'Affiliation': 'Autores del Grupo Rituman.'}]",Archivos espanoles de urologia,[]
2163,32633541,Time to Clinical Response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study.,"Objectives:  We investigated the time course of clinical response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study (TEOSS).  Methods:  TEOSS randomized 119 predominantly outpatient youth ages 8-19 years with schizophrenia or schizoaffective disorder to 8 weeks of treatment with molindone, risperidone, or olanzapine. We used proportional hazards regression to determine whether these three antipsychotics differed in the time until clinical response, defined as the time from treatment initiation to the point of achieving a Clinical Global Impressions-Improvement (CGI-I) scale score of 1 (""very much improved"") or 2 (""much improved"") that was maintained until week 8.  Results:  Of the 116 youth who initiated treatment, 56 (48%) achieved clinical response. Among clinical responders, the median (±interquartile range) time until clinical response was 4.0 (±4.0) weeks for olanzapine, 4.5 (±4.0) weeks for risperidone, and 6.0 (±4.0) weeks for molindone. There were no significant differences in time course for clinical response between medications ( p  = 0.84). Youth without symptom improvement (CGI-I ≥ 4) after 3 weeks were more likely to be clinical nonresponders at week 8 (relative risk ratio = 1.98, 95% confidence interval 1.29-3.05), compared with youth with at-least-minimal symptom improvement after 3 weeks when looking at all antipsychotics combined.  Conclusion:  To our knowledge, our study is the first to investigate medication differences in treatment response timing in early onset schizophrenia spectrum disorders. Clinical response times for molindone, risperidone, and olanzapine were not significantly different. Furthermore, while lack of early improvement predicted clinical nonresponse, whether or not to continue antipsychotic treatment after 3 or more weeks without symptom improvement should be based on clinical judgment after weighing potential risks, benefits, and alternatives. ClinicalTrials.gov Identifier: NCT00053703.",2020,"after 3 weeks were more likely to be clinical nonresponders at week 8 (relative risk ratio = 1.98, 95% confidence interval 1.29-3.05), compared with youth with at-least-minimal symptom improvement after 3 weeks when looking at all antipsychotics combined.  ","['119 predominantly outpatient youth ages 8-19 years with schizophrenia or schizoaffective disorder to 8 weeks of treatment with', '116 youth who initiated treatment, 56 (48%) achieved']","['molindone, risperidone, and olanzapine', 'olanzapine', 'molindone, risperidone, or olanzapine', 'risperidone']","['time course for clinical response', 'Clinical Global Impressions-Improvement (CGI-I) scale score', 'median (±interquartile range) time until clinical response', 'clinical response', 'Youth without symptom improvement (CGI']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0026388', 'cui_str': 'Molindone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",119.0,0.0595846,"after 3 weeks were more likely to be clinical nonresponders at week 8 (relative risk ratio = 1.98, 95% confidence interval 1.29-3.05), compared with youth with at-least-minimal symptom improvement after 3 weeks when looking at all antipsychotics combined.  ","[{'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Taylor', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Appel', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eli', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Alexander-Bloch', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Maayan', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Raquel E', 'Initials': 'RE', 'LastName': 'Gur', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bloch', 'Affiliation': 'Department of Psychiatry, Child Study Center, Yale University, New Haven, Connecticut, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0030']
2164,32633571,Does Question Format Matter in Assessing the Prevalence of Sexual Aggression? A Methodological Study.,"As research on sexual aggression has been growing, methodological issues in assessing prevalence rates have received increased attention. Building on work by Abbey and colleagues about effects of question format, participants in this study (1,253; 621 female; 632 male) were randomly assigned to one of two versions of the Sexual Aggression and Victimization Scale (SAV-S). In Version 1, the coercive tactic (use/threat of physical force, exploitation of the inability to resist, verbal pressure) was presented first, and sexual acts (sexual touch, attempted and completed sexual intercourse, other sexual acts) were presented as subsequent questions. In Version 2, sexual acts were presented first, and coercive tactics as subsequent questions. No version effects emerged for overall perpetration rates reported by men and women. The overall victimization rate across all items was significantly higher in the tactic-first than in the sexual-act-first conditions for women, but not for men. Classifying participants by their most severe experience of sexual victimization showed that fewer women were in the nonvictim category and more men were in the nonconsensual sexual contact category when the coercive tactic was presented first. Sexual experience background did not moderate the findings. The implications for the measurement of self-reported sexual aggression victimization and perpetration are discussed.",2020,"The overall victimization rate across all items was significantly higher in the tactic-first than in the sexual-act-first conditions for women, but not for men.","['participants in this study (1,253; 621 female; 632 male']",['Sexual Aggression and Victimization Scale (SAV-S'],"['overall perpetration rates', 'coercive tactic (use/threat of physical force, exploitation of the inability to resist, verbal pressure', 'overall victimization rate']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0336996', 'cui_str': 'Physical force'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",1253.0,0.0194632,"The overall victimization rate across all items was significantly higher in the tactic-first than in the sexual-act-first conditions for women, but not for men.","[{'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Schuster', 'Affiliation': 'Department of Education and Psychology, Free University of Berlin , Germany.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Tomaszewska', 'Affiliation': 'Department of Psychology, University of Potsdam , Germany.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Marchewka', 'Affiliation': 'Department of Psychology, University of Potsdam , Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Krahé', 'Affiliation': 'Department of Psychology, University of Potsdam , Germany.'}]",Journal of sex research,['10.1080/00224499.2020.1777927']
2165,32633646,"""Lift Big-Get Big"": The Impact of Images of Hyper-Muscular Bodies and Training Information.","Purpose : It has been suggested that the media influence beliefs regarding ideal body appearance and drive for muscularity whilst also offering recommendations for achieving this; most commonly heavy load free weight resistance training (RT). However, evidence for media effects are inconsistent in the literature. This study investigated this ""lift big-get big"" culture and effects of imagery on males' beliefs regarding RT.  Method : An online survey was conducted with male participants ( N  = 110) randomized to different images (hyper-muscular/lean/control) and RT information (""lift big-get big""/""evidence based RT""/control).  Results : Descriptive data suggested belief in necessity of heavy loads and free weights was pervasive. There was a small significant effect of condition for multivariate analysis of beliefs regarding RT. Univariate analyses showed significant effects of condition regarding the importance of free weights and heavy loads for strength, and free weights for hypertrophy. Small to moderate effects were found comparing ""evidence-based RT"" with a hyper-muscular physique to ""lift big-get big"" conditions with both hyper-muscular and lean physiques, the latter more likely to agree free weights and heavy loads are necessary for strength. A small effect was found comparing ""lift big-get big"" conditions with both hyper-muscular and lean physiques and the control condition, the former more likely to agree free weights are necessary for hypertrophy.  Conclusions : Although hyper-muscular bodies alone did not influence RT beliefs, new information, i.e., ""evidence-based RT"" combined with a hyper-muscular physique had a small effect. The ""lift big-get big"" culture is perhaps pervasive enough that most conditions merely reinforced existing beliefs.",2020,"A small effect was found comparing ""lift big-get big"" conditions with both hyper-muscular and lean physiques and the control condition, the former more likely to agree free weights are necessary for hypertrophy.  ","['male participants ( N \xa0=\xa0110', ""males' beliefs regarding RT""]","['randomized to different images (hyper-muscular/lean/control) and RT information (""lift big-get big""/""evidence based RT""/control', 'Lift Big-Get Big']","['free weights and heavy loads for strength, and free weights for hypertrophy']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",110.0,0.0521289,"A small effect was found comparing ""lift big-get big"" conditions with both hyper-muscular and lean physiques and the control condition, the former more likely to agree free weights are necessary for hypertrophy.  ","[{'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Martino', 'Affiliation': 'Southampton Solent University.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'Southampton Solent University.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wink', 'Affiliation': 'Southampton Solent University.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Ukactive Research Institute.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'Southampton Solent University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1752357']
2166,32633854,Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: A feasibility-randomised controlled trial.,"Chronic, nonhealing diabetic foot ulcers (DFU) are increasing in prevalence and are often unresponsive to conventional therapy. Adipose tissue, containing adipose-derived stem cells, and platelet rich plasma (PRP) are regenerative therapies rich in growth factors which may provide a solution to chronic wound healing. This study aimed to assess the feasibility of conducting a definitive randomised controlled trial (RCT) to investigate the efficacy of these therapies for the treatment of DFU. This was a single centre, feasibility, three-arm, parallel group RCT. Eligible DFU patients were randomised on a 1:1:1 basis to three intervention arms: control (podiatry); fat grafting; fat grafting with PRP. The intervention was delivered once and patients were followed-up for 12 weeks. The primary objective was to assess measures of trial feasibility. Clinical outcomes and health-related quality of life (HRQoL) were also evaluated. Three hundred and thirty four patients were screened and 32 patients (9.6%) were deemed eligible with 18 enrolled in the trial (6 per arm) over 17 months. All participants completed the trial with no withdrawals or crossover. Participant engagement was high with most HRQoL questionnaires returned and only 4.8% follow-up appointments missed. There were five adverse events (AEs) related to the trial with no serious AEs. Five (28%) of the wounds healed. There was no difference between any of the groups in terms of clinical outcomes. This feasibility study demonstrated that a multi-centre RCT is safe and feasible with excellent patient engagement. We have highlighted crucial information regarding methodology and recruitment, which will guide future trial design. Registration number: NCT03085550 clinicaltrials.gov. Registered 01/03/2017.",2020,There was no difference between any of the groups in terms of clinical outcomes.,"['Eligible DFU patients', 'Three hundred and thirty four patients were screened and 32 patients (9.6%) were deemed eligible with 18 enrolled in the trial (6 per arm) over 17\u2009months', 'diabetic foot ulcers']","['control (podiatry); fat grafting; fat grafting with PRP', 'multi-centre RCT', 'Fat grafting and platelet-rich plasma']",['Clinical outcomes and health-related quality of life (HRQoL'],"[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",334.0,0.261112,There was no difference between any of the groups in terms of clinical outcomes.,"[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Smith', 'Affiliation': 'Department of Plastic Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leigh', 'Affiliation': 'Department of Podiatry, Royal Free Hospital, London, UK.'}, {'ForeName': 'Muholan', 'Initials': 'M', 'LastName': 'Kanapathy', 'Affiliation': 'Department of Plastic Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Macneal', 'Affiliation': ""Department of Plastic Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Jell', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hachach-Haram', 'Affiliation': 'Department of Plastic Surgery, Royal Free Hospital, London, UK.'}, {'ForeName': 'Haroon', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'Department of Trauma and Orthopaedics, Royal Free Hospital, London, UK.'}, {'ForeName': 'Ash', 'Initials': 'A', 'LastName': 'Mosahebi', 'Affiliation': 'Department of Plastic Surgery, Royal Free Hospital, London, UK.'}]",International wound journal,['10.1111/iwj.13433']
2167,32633861,Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion.,"BACKGROUND


Branch retinal vein occlusion (BRVO) is one of the most commonly occurring retinal vascular abnormalities. The most common cause of visual loss in people with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss. Limitations to this treatment exist, however, and newer modalities may have equal or improved efficacy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has recently been used successfully to treat MO resulting from a variety of causes.
OBJECTIVES


To investigate the efficacy and gather evidence from randomised controlled trials (RCTs) on the potential harms of anti-vascular endothelial growth factor (VEGF) agents for the treatment of macular oedema (MO) secondary to branch retinal vein occlusion (BRVO).
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); MEDLINE Ovid; Embase Ovid; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. The date of the last search was 12 June 2019.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) investigating BRVO. Eligible trials had to have at least six months' follow-up where anti-VEGF treatment was compared with another treatment, no treatment, or placebo. We excluded trials where combination treatments (anti-VEGF plus other treatments) were used; and trials that investigated the dose and duration of treatment without a comparison group (other treatment/no treatment/sham).
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted the data using standard methodological procedures expected by Cochrane. The primary outcome was the proportion of participants with an improvement from baseline in best-corrected visual acuity of greater than or equal to 15 letters (3 lines) on the Early Treatment in Diabetic Retinopathy Study (ETDRS) Chart at six months and 12 months of follow-up. The secondary outcomes were the proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change at six and 12 months, as well as the change in central retinal thickness (CRT) on optical coherence tomography from baseline at six and 12 months. We also collected data on adverse events and quality of life (QoL).
MAIN RESULTS


We found eight RCTs of 1631 participants that met the inclusion criteria after independent and duplicate review of the search results. These studies took place in Europe, North America, Eastern Mediterranean region and East Asia. Included participants were adults aged 18 or over with VA of 20/40 or worse. Studies varied by duration of disease but permitted previously treated eyes as long as there was sufficient treatment-free interval. All anti-VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone) were included. Overall, we judged the studies to be at moderate or unclear risk of bias. Four of the eight studies did not mask participants or outcome assessors, or both. One trial compared anti-VEGF to sham. At six months, eyes receiving anti-VEGF were significantly more likely to have a gain of 15 or more ETDRS letters (risk ratio (RR) 1.72, 95% confidence interval (CI) 1.19 to 2.49; 283 participants; moderate-certainty evidence). Mean VA was better in the anti-VEGF group at six months compared with control (mean difference (MD) 7.50 letters, 95% CI 5.29 to 9.71; 282 participants; moderate-certainty evidence). Anti-VEGF also proved more effective at reducing CRT at six months (MD -57.50 microns, 95% CI -108.63 to -6.37; 281 participants; lower CRT is better; moderate-certainty evidence). There was only very low-certainty evidence on adverse effects. There were no reports of endophthalmitis. Mean change in QoL (measured using the National Eye Institute Visual Functioning Questionnaire VFQ-25) was better in people treated with anti-VEGF compared with people treated with sham (MD 7.6 higher score, 95% CI 4.3 to 10.9; 281 participants; moderate-certainty evidence). Three RCTs compared anti-VEGF with macular laser (total participants = 473). The proportion of eyes gaining 15 or more letters was greater in the anti-VEGF group at six months (RR 2.09, 95% CI 1.44 to 3.05; 2 studies, 201 participants; moderate-certainty evidence). Mean VA in the anti-VEGF groups was better than the laser groups at six months (MD 9.63 letters, 95% CI 7.23 to 12.03; 3 studies, 473 participants; moderate-certainty evidence). There was a greater reduction in CRT in the anti-VEGF group compared with the laser group at six months (MD -147.47 microns, 95% CI -200.19 to -94.75; 2 studies, 201 participants; moderate-certainty evidence). There was only very low-certainty evidence on adverse events. There were no reports of endophthalmitis. QoL outcomes were not reported. Four studies compared anti-VEGF with intravitreal steroid (875 participants). The proportion of eyes gaining 15 or more ETDRS letters was greater in the anti-VEGF group at six months (RR 1.67, 95% CI 1.33 to 2.10; 2 studies, 330 participants; high-certainty evidence) and 12 months (RR 1.76, 95% CI 1.36 to 2.28; 1 study, 307 participants; high-certainty evidence). Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence). Mean CRT also showed a greater reduction in the anti-VEGF arm at 12 months compared with intravitreal steroid (MD -26.92 microns, 95% CI -65.88 to 12.04; 2 studies, 343 participants; moderate-certainty evidence). People receiving anti-VEGF showed a greater improvement in QoL at 12 months compared to those receiving steroid (MD 3.10, 95% CI 0.22 to 5.98; 1 study, 307 participants; moderate-certainty evidence). Moderate-certainty evidence suggested increased risk of cataract and raised IOP with steroids. There was only very low-certainty evidence on APTC events. No cases of endophthalmitis were observed.
AUTHORS' CONCLUSIONS


The available RCT evidence suggests that treatment of MO secondary to BRVO with anti-VEGF improves visual and anatomical outcomes at six and 12 months.",2020,"Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence).","['macular oedema (MO) secondary to branch retinal vein occlusion (BRVO', '1631 participants that met the inclusion criteria after independent and duplicate review of the search results', 'Included participants were adults aged 18 or over with VA of 20/40 or worse', 'Europe, North America, Eastern Mediterranean region and East Asia', 'macular oedema secondary to branch retinal vein occlusion', 'people with BRVO is macular oedema (MO']","['comparison group (other treatment/no treatment/sham', 'anti-VEGF with intravitreal steroid', 'Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF', 'placebo', 'anti-VEGF', 'Branch retinal vein occlusion (BRVO', 'VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone', 'Grid or focal laser photocoagulation', 'anti-vascular endothelial growth factor (VEGF) agents', 'Anti-vascular endothelial growth factor']","['CRT', 'visual and anatomical outcomes', 'gain of 15 or more ETDRS letters', 'visual loss', 'endophthalmitis', 'central retinal thickness (CRT', 'Diabetic Retinopathy Study (ETDRS', 'risk of visual loss', 'adverse events', 'adverse events and quality of life (QoL', 'QoL', 'proportion of eyes gaining 15 or more ETDRS letters', 'QoL outcomes', 'proportion of participants with an improvement from baseline in best-corrected visual acuity', 'proportion of eyes gaining 15 or more letters', 'Mean VA', 'Mean CRT', 'proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change', 'National Eye Institute Visual Functioning Questionnaire VFQ-25', 'adverse effects', 'Mean change in QoL']","[{'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0282645', 'cui_str': 'Mediterranean Region'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0948675', 'cui_str': 'Focal laser photocoagulation'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",307.0,0.421011,"Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence).","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Shalchi', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mahroo', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'London, UK.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Mitry', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009510.pub3']
2168,32633896,The effect of transcutaneous application of gaseous CO 2  on diabetic chronic wound healing-A double-blind randomized clinical trial.,"Chronic wounds in diabetics are difficult to treat, therefore, adjuvant therapies have been investigated. Bathing in CO 2  -rich water (spa therapy) has been known in Europe for decades for its positive effect on peripheral vascular disorders. Recently, much effort has been invested in developing optimal application methods of CO 2  . Uses include subcutaneous injections of CO 2  , bathing in CO 2  -enriched water, and transcutaneous application of CO 2  . To verify the effect of transcutaneous application of gaseous CO 2  on the healing of chronic diabetic wounds, a randomized double-blind clinical research was designed. The research included 30 and 27 wounds in the study and control groups, respectively. In addition to standard treatment, patients in the study group received 20 therapies with medical-grade CO 2  gas and the control group received the same treatment with air. Results showed significantly faster healing in the study group: 20 of the 30 wounds in the study group were healed compared with none in the control group. Mean wound surface and volume in the study group was reduced significantly (surface: 96%, P = .001, volume: 99%, P = .003) compared with a small reduction in the control group (surface: 25%, P = .383, volume: 27%, P = .178). Considering our results, transcutaneous application of gaseous CO 2  is an effective adjuvant therapy in diabetic chronic wound treatment.",2020,"Mean wound surface and volume in the study group was reduced significantly (surface: 96%, P = .001, volume: 99%, P = .003) compared with a small reduction in the control group (surface: 25%, P = .383, volume: 27%, P = .178).",['chronic diabetic wounds'],"['gaseous CO 2', 'transcutaneous application of gaseous CO 2', '20 therapies with medical-grade CO 2  gas and the control group received the same treatment with air']","['diabetic chronic wound healing', 'Mean wound surface and volume', 'faster healing']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0542646,"Mean wound surface and volume in the study group was reduced significantly (surface: 96%, P = .001, volume: 99%, P = .003) compared with a small reduction in the control group (surface: 25%, P = .383, volume: 27%, P = .178).","[{'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Macura', 'Affiliation': 'Department for surgical infections, University Medical center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Ban Frangez', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Cankar', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Finžgar', 'Affiliation': 'Faculty of Mechanical Engineering, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Frangez', 'Affiliation': 'Department for surgical infections, University Medical center Ljubljana, Ljubljana, Slovenia.'}]",International wound journal,['10.1111/iwj.13436']
2169,32633901,Time course of pupillary response to threat words before and after attention bias modification for transdiagnostic anxiety disorders: A randomized controlled trial.,"INTRODUCTION


Altered attention to threatening stimuli at initial and sustained stages of processing may be dissociable dimensions that influence the development and maintenance of transdiagnostic symptoms of anxiety, such as vigilance, and possibly require distinct intervention. Attention bias modification (ABM) interventions were created to implicitly train attention away from threatening stimuli and have shown efficacy in treating anxiety. ABM alters neurocognitive functioning during initial stages of threat processing, but less is known regarding effects of ABM on neural indices of threat processing at sustained (i.e., intermediate and late) stages, or if ABM-related neural changes relate to symptom response. The current study utilized pupillary response as a temporally sensitive and cost-effective peripheral marker of neurocognitive response to ABM.
MATERIALS AND METHODS


In a randomized controlled trial, 79 patients with transdiagnostic anxiety provided baseline data, 70 were randomized to receive eight sessions of twice-weekly ABM (n = 49) or sham training (n = 21), and 65 completed their assigned treatment condition and returned for post-training assessment.
RESULTS


Among ABM, but not sham, patients, pupillary response to threat words during initial and intermediate stages decreased from pre- to post-training. Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
CONCLUSIONS


All measured stages of threat processing had relevance in understanding the neural mechanisms of ABM, with overlapping yet dissociable roles exhibited within a single neurophysiological marker across an initial-intermediate-late time continuum. Pupillometry may be well suited to measure both target engagement and treatment outcome following ABM.",2020,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","['79 patients with transdiagnostic anxiety provided baseline data, 70', 'transdiagnostic anxiety disorders']","['ABM', 'twice-weekly ABM (n\xa0=\xa049) or sham training']",['pupillary response to threat words during initial and intermediate stages'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",79.0,0.0719312,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","[{'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Woody', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Vaughn-Coaxum', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Siegle', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Brain and behavior,['10.1002/brb3.1664']
2170,32633899,Corticomotor reorganization during short-term visuomotor training in the lower back: A randomized controlled study.,"INTRODUCTION


Accumulating evidence suggests that motor skill training is associated with structural and functional reorganization of the primary motor cortex. However, previous studies have focussed primarily upon the upper limb, and it is unclear whether comparable reorganization occurs following training of other regions, such as the lower back. Although this holds important implications for rehabilitation, no studies have examined corticomotor adaptations following short-term motor training in the lower back.
METHOD


The aims of this study were to (a) determine whether a short-term lumbopelvic tilt visuomotor task induced reorganization of the corticomotor representations of lower back muscles, (b) quantify the variability of corticomotor responses to motor training, and (c) determine whether any improvements in task performance were correlated with corticomotor reorganization. Participants were allocated randomly to perform a lumbopelvic tilt motor training task (n = 15) or a finger abduction control task involving no lumbopelvic movement (n = 15). Transcranial magnetic stimulation was used to map corticomotor representations of the lumbar erector spinae before, during, and after repeated performance of the allocated task.
RESULTS


No relationship between corticomotor reorganization and improved task performance was identified. Substantial variability was observed in terms of corticomotor responses to motor training, with approximately 50% of participants showing no corticomotor reorganization despite significant improvements in task performance.
CONCLUSION


These findings suggest that short-term improvements in lower back visuomotor task performance may be driven by changes in remote subcortical and/or spinal networks rather than adaptations in corticomotor pathways. However, further research using tasks of varying complexities and durations is required to confirm this hypothesis.",2020,No relationship between corticomotor reorganization and improved task performance was identified.,[],"['motor skill training', 'Corticomotor reorganization during short-term visuomotor training', 'Transcranial magnetic stimulation', 'lumbopelvic tilt motor training task (n\xa0=\xa015) or a finger abduction control task involving no lumbopelvic movement']","['task performance', 'lower back visuomotor task performance']",[],"[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0295293,No relationship between corticomotor reorganization and improved task performance was identified.,"[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Cavaleri', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Chipchase', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Massé-Alarie', 'Affiliation': 'CIRRIS Research Centre, Department of Rehabilitation, Laval University, Quebec, Canada.'}, {'ForeName': 'Siobhan M', 'Initials': 'SM', 'LastName': 'Schabrun', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Muath A', 'Initials': 'MA', 'LastName': 'Shraim', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",Brain and behavior,['10.1002/brb3.1702']
2171,32628922,"Incidence and outcome of uveitic glaucoma in eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to fluocinolone acetonide implant or systemic therapy.","PURPOSE


To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN


Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort METHODS: Patients with intermediate, posterior or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS


Among 405 uveitic at-risk eyes of 232 patients (median follow-up=6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant upon implantation) developed glaucoma (Hazard Ratio (HR)=5.9 (95% CI: 3.2, 10.8); p<0.001). Adjustment for IOP elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR=3.1 (95% CI: 1.6, 6.0); p=0.001. Among 112 eyes of 83 patients developing glaucoma, the five year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI: 12%, 33%); five year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI: 17%, 39%).
CONCLUSIONS


Implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by post-treatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely. ClinicalTrials.gov Identifier: NCT00132691.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts;; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts;; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia;. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'the Center for Clinical Trials and Evidence Synthesis; Departments of Epidemiology.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'the Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina; The Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'the Center for Clinical Trials and Evidence Synthesis; Departments of Epidemiology.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'the Center for Clinical Trials and Evidence Synthesis; Departments of Epidemiology; Departments of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'the Center for Clinical Trials and Evidence Synthesis; Departments of Epidemiology; The Johns Hopkins University School of Medicine Wilmer Eye Institute.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
2172,32629032,Transcranial direct current stimulation and visual illusion effect according to sensory phenotypes in patients with spinal cord injury and neuropathic pain.,"Treatment of neuropathic pain (NP) in patients with spinal cord injury (SCI) remains a major challenge. The aim of the present study is to investigate if the effect of transcranial direct current stimulation (tDCS) combined with visual illusion (VI), following a previously published protocol, has differential effects on pain-related sensory symptoms according to sensory phenotypes profiles. One hundred and thirty SCI patients with NP participated in this open-label trial. Sixty-five patients were given a daily 20-minutes combined treatment of tDCS and VI for 2 weeks. Sixty-five patients served as a control group. Clinical assessment was performed before and 2 weeks later, by using Neuropathic Pain Symptom Inventory (NPSI), Brief Pain Inventory (BPI), and Patient Health Questionnaire-9 (PHQ-9). There was significant improvement in the combined treatment group according to NPSI, BPI and PHQ-9, but no changes in the control group. Following a cluster analysis of NPSI items at baseline assessment, five subgroups of patients with different pain-related characteristics were identified among the treated group, although differences between clusters were not significant. There was also improvement in mood, sleep quality, and enjoyment of life in the treated group. Despite a reduction of NP with the combined treatment, the analysis of sensory phenotype pain profiles does not provide a predictive value regarding the analgesic results of this combined neuromodulatory treatment. Perspective In this article we confirm the analgesic effect of a combined neuromodulatory therapy, transcranial direct current stimulation associated with visual illusion in patients with NP after an SCI. We have identified five clusters of NP with distinct sensory phenotypes, but there was not any specific sensory phenotype cluster that significantly responded to the combined therapy better than the other.",2020,"There was significant improvement in the combined treatment group according to NPSI, BPI and PHQ-9, but no changes in the control group.","['patients with spinal cord injury and neuropathic pain', 'patients with NP after an SCI', 'patients with spinal cord injury (SCI', 'One hundred and thirty SCI patients with NP']","['transcranial direct current stimulation (tDCS) combined with visual illusion (VI', 'Transcranial direct current stimulation and visual illusion', 'combined neuromodulatory therapy, transcranial direct current stimulation']","['NPSI, BPI and PHQ-9', 'mood, sleep quality, and enjoyment of life', 'neuropathic pain (NP', 'Neuropathic Pain Symptom Inventory (NPSI), Brief Pain Inventory (BPI), and Patient Health Questionnaire-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0751246', 'cui_str': 'Illusions, Visual'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life'}]",65.0,0.0870397,"There was significant improvement in the combined treatment group according to NPSI, BPI and PHQ-9, but no changes in the control group.","[{'ForeName': 'Dolors', 'Initials': 'D', 'LastName': 'Soler', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain. Electronic address: dsoler@guttmann.com.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moriña', 'Affiliation': 'Barcelona Graduate School of Mathematics (BGSMath), Departament de Matemàtiques, Universitat Autònoma de Barcelona, Bellaterra, Spain.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Kumru', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Navarro', 'Affiliation': 'Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Dept Cell Biology, Physiology and Immunology, and Institute of Neurosciences, Universitat Autònoma de Barcelona, and CIBERNED, Bellaterra, Spain.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.06.004']
2173,32629078,Knowledge-based assessment of focal dose escalation treatment plans in prostate cancer.,"PURPOSE


In a randomized focal dose escalation radiotherapy trial for prostate cancer ([X]), up to 95 Gy was prescribed to the tumor in the dose-escalated arm, with 77 Gy to the entire prostate in both arms. As dose constraints to organs at risk (OARs) had priority over dose escalation and suboptimal planning could occur, we investigated how well the dose to the tumor was boosted. We developed an anatomy-based prediction model to identify plans with suboptimal tumor dose, and performed replanning to validate our model.
METHODS AND MATERIALS


We derived dose-volume parameters from planned dose distributions of 539 [X] patients in 4 institutions and compared them between both arms. In the dose-escalated arm, we determined Overlap Volume Histograms (OVHs) and derived features representing patient anatomy. We predicted tumor D 98%  with a linear regression on anatomical features and performed replanning on 21 plans.
RESULTS


In the dose-escalated arm, the median tumor D 50%  and D 98%  were 93.0 and 84.7 Gy, and 99% of the tumors had a dose escalation above 82.4 Gy (107% of 77 Gy). In both arms OAR constraints were met. Five out of 73 anatomical features were found to be predictive for tumor D 98% . Median predicted tumor D 98%  was 4.4 Gy higher than planned D 98% . Upon replanning median tumor D 98%  increased by 3.0 Gy. A strong correlation between predicted increase in D 98%  and realized increase upon replanning was found (ρ = 0.86).
CONCLUSIONS


Focal dose escalation in prostate cancer was feasible with a dose escalation to 99% of the tumors. Replanning resulted in an increased tumor dose that correlated well with the prediction model. The model was able to identify tumors on which a higher boost dose could be planned. The model has potential as a QA tool in focal dose escalated treatment plans.",2020,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"['539 [X] patients in 4 institutions and compared them between both arms', 'prostate cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0291957,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"[{'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van Schie', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands. Electronic address: m.v.schie@nki.nl.'}, {'ForeName': 'Tomas M', 'Initials': 'TM', 'LastName': 'Janssen', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Ruiter', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexis N T J', 'Initials': 'ANTJ', 'LastName': 'Kotte', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Linda G W', 'Initials': 'LGW', 'LastName': 'Kerkmeijer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Draulans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'de Roover', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kunze-Busch', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Smeenk', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.072']
2174,32629091,Early-onset pneumonia following bag-mask ventilation versus endotracheal intubation during cardiopulmonary resuscitation: A substudy of the CAAM trial.,"AIM


Early-onset pneumonia (EOP) is a common in-hospital complication in survivors of out-of-hospital cardiac arrest. In this substudy of the CAAM trial, we aimed to compare whether bag mask ventilation (BMV) compared to endotracheal intubation (ETI) performed during cardiopulmonary resuscitation increases the risk of developing EOP.
METHODS


Adult patients from the CAAM trial that survived beyond 12 hours of hospitalization were included. Information about in-hospital management and outcome of study subjects was systematically collected. Our primary aim was to compare the incidence of EOP in the BMV and ETI group using a series of bivariate analysis adjusting for one variable at a time and a logistic regression controlled for survival beyond 96 hours, age, gender, catecholamine administration, no flow time, and initial shockable rhythm.
RESULTS


Of 627 patients from the CAAM trial that survived to hospital admission, 409 patients were hospitalized beyond 12 hours and thus included (202 randomized to BMV and 20 7 randomized to ETI). Patients in the BMV group had a significantly longer period of unsecured airway during prehospital cardiopulmonary resuscitation (BMV (median): 33 minutes; ETI (median): 17 minutes, p < 0.0001). No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0). We found no difference in the development of EOP according to airway management in the series of bivariate analyses or in the multivariable regression analysis either.
CONCLUSION


In this substudy of the CAAM trial, development of early-onset pneumonia in out-of-hospital cardiac arrest survivors did not depend on airway management technique during CPR.
TRIAL REGISTRATION


NCT02327026.",2020,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","['cardiopulmonary resuscitation', 'Adult patients from the CAAM trial that survived beyond 12\u2009hours of hospitalization were included', '627 patients from the CAAM trial that survived to hospital admission', '409 patients were hospitalized beyond 12\u2009hours and thus included (202 randomized to BMV and 20 7 randomized to ETI']","['endotracheal intubation (ETI', 'bag-mask ventilation versus endotracheal intubation', 'bag mask ventilation (BMV']","['development of EOP according to airway management', 'risk of developing EOP', 'incidence of EOP']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",627.0,0.0603892,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","[{'ForeName': 'Josefine S', 'Initials': 'JS', 'LastName': 'Baekgaard', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark; Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France. Electronic address: josefine.stokholm.baekgaard.01@regionh.dk.'}, {'ForeName': 'Mohamed N', 'Initials': 'MN', 'LastName': 'Triba', 'Affiliation': ""Sorbonne Paris Cité, Equipe Nanomédecine Biomarqueurs Détection, Laboratoire de Chimie, Structures et Propriétés de Biomateriaux et d'Agents Therapeutiques, UMR CNRS 7244, University Paris 13 Bobigny, France.""}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Brandeis', 'Affiliation': 'Service des Urgences, Hopital Ballanger, 93600 Aulnays, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Intensive Care Unit, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}]",Resuscitation,['10.1016/j.resuscitation.2020.06.011']
2175,32629112,Antibiotic Route and Duration of Therapy for Cellulitis: Data Extracted from a Multi-Center Clinical Trial.,"INTRODUCTION


Although cellulitis is a relatively common condition there is uncertainty regarding the benefit of intravenous (IV) over oral (PO) antibiotic therapy, and the appropriate duration of treatment.
METHODS


We used data extracted from a clinical trial (NCT01876628) of antibiotic therapy for cellulitis to assess the association between the route of administration and duration of treatment, and clinical outcome.
RESULTS


Of 323 patients with antibiotic data, 114 patients received some IV therapy. IV antibiotic therapy was preferred in those who had received antibiotics prior to trial entry (p<0.001). Patients characterised as having more severe cellulitis (C-reactive protein >100mg/L, affected skin surface area >5% or systemic inflammatory response syndrome (SIRS) score ≥1) were more likely to have IV therapy. Patients given only PO therapy were more likely to have improved at day 5 compared to those given at least a single dose of IV therapy (p=0.0153), and were as likely to be back to their normal activities at day 10 (p=0.8982), and day 30 (p=0.8602). There was no association between initial severity and the duration of antibiotic therapy given within the trial. There was no association between duration of antibiotic therapy and outcome as measured at day 10 and day 30.
CONCLUSIONS


This study provides evidence that recovery is not associated with the route of antibiotic administration for patients with cellulitis of similar severity, or that course lengths of more than five days result in any additional benefit.",2020,IV antibiotic therapy was preferred in those who had received antibiotics prior to trial entry (p<0.001).,"['323 patients with antibiotic data', '114 patients received some IV therapy']","['antibiotic therapy', 'IV antibiotic therapy', 'intravenous (IV) over oral (PO) antibiotic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0559680', 'cui_str': 'Intravenous antibiotic therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0559681', 'cui_str': 'Oral antibiotic therapy'}]",[],323.0,0.0803809,IV antibiotic therapy was preferred in those who had received antibiotics prior to trial entry (p<0.001).,"[{'ForeName': 'O Martin', 'Initials': 'OM', 'LastName': 'Williams', 'Affiliation': 'Public Health England Microbiology Services Bristol, Bristol Royal Infirmary, Bristol, UK.; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK, BS2 8HW. Electronic address: martinx.williams@uhbristol.nhs.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brindle', 'Affiliation': 'Public Health England Microbiology Services Bristol, Bristol Royal Infirmary, Bristol, UK.; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK, BS2 8HW; School of Clinical Sciences, University of Bristol, Bristol, UK, BS2 8DZ. Electronic address: Richard.brindle@bristol.ac.uk.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106076']
2176,32638614,"Efficacy of high-intensity laser therapy on arthropathy of the hands in patients with systemic lupus erythematosus: a double-blinded, randomized controlled trial.","OBJECTIVE


To determine the efficacy of high-intensity laser therapy (HILT) on arthropathy of the hands in patients with systemic lupus erythematosus.
DESIGN


A double-blinded randomized, controlled study.
SETTING


Outpatient setting.
PARTICIPANTS


Fifty patients, 30-50-years-old, suffering from arthropathy of the hands were randomly assigned either into the experimental group, received HILT plus the routine physical therapy program or the control group, received sham HILT plus the same routine physical therapy program.
INTERVENTION


All treatment interventions were applied at a frequency of three sessions per week for eight weeks.
OUTCOME MEASURES


Handgrip strength, joints swelling counts, joints tenderness counts, visual analog scale (VAS) were measured before and after eight-weeks of interventions.
RESULTS


There were statistically significant differences in handgrip strength, joint swelling count, joint tenderness count and VAS in favor of the study group ( P  < 0.05). After eight-weeks of intervention, the mean (SD) for handgrip strength, joint swelling counts, joint tenderness count, and pain score was 28.34 ± 8.3 kg, 4.4 ± 2.18, 5 ± 2.1, and 35.6 ± 13.87 mm in the study group, and 22.96 ± 8.76 kg, 7.36 ± 2.14, 9.08 ± 1.63, and 58.8 ± 10.54 mm in the control group, respectively. The MD (95%CI) for handgrip strength, joint swelling counts, joint tenderness count, and pain score was 5.38(0.53,10.23) kg, -2.96(-4.19, -1.73), -4.08(-5.15, -3.01), and -23.2(-30.2, -16.2) mm between groups, respectively.
CONCLUSIONS


Adding HILT to the routine physical therapy program might be more effective than routine physical therapy program alone in improving handgrip strength, decreasing joint swelling counts, joint tenderness counts, and pain in patients with arthropathy of the hands.",2020,"There were statistically significant differences in handgrip strength, joint swelling count, joint tenderness count and VAS in favor of the study group ( P  < 0.05).","['patients with arthropathy of the hands', 'Fifty patients, 30-50-years-old, suffering from arthropathy of the hands', 'Outpatient setting', 'patients with systemic lupus erythematosus']","['HILT plus the routine physical therapy program or the control group, received sham HILT plus the same routine physical therapy program', 'high-intensity laser therapy', 'high-intensity laser therapy (HILT']","['handgrip strength, decreasing joint swelling counts, joint tenderness counts, and pain', 'MD (95%CI) for handgrip strength, joint swelling counts, joint tenderness count, and pain score', 'mean (SD) for handgrip strength, joint swelling counts, joint tenderness count, and pain score', 'Handgrip strength, joints swelling counts, joints tenderness counts, visual analog scale (VAS', 'Efficacy', 'handgrip strength, joint swelling count, joint tenderness count and VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.0685925,"There were statistically significant differences in handgrip strength, joint swelling count, joint tenderness count and VAS in favor of the study group ( P  < 0.05).","[{'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of physical therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Khadra Mohamed', 'Initials': 'KM', 'LastName': 'Ali', 'Affiliation': 'Department of physical therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Hadaya Mosaad', 'Initials': 'HM', 'LastName': 'Eladl', 'Affiliation': 'Department of physical therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Clinical rehabilitation,['10.1177/0269215520941059']
2177,32638615,The Feasibility and Efficacy of a Brief Integrative Treatment for Adults With Depression and/or Anxiety: A Randomized Controlled Trial.,"The aim of this study was to investigate the efficacy and suitability of a brief integrative intervention, Personalized Integrative Therapy (PI Therapy), for the treatment of adult depression and/or anxiety. In this 6-week, 3-arm, parallel-group, randomized trial, PI Therapy delivered alone or with nutritional supplements (PI Therapy + Supps) was compared to cognitive behavior therapy (CBT) in 48 adults with depression and/or anxiety. All treatments were delivered as a 1-day workshop plus 6 weeks of reminder phone text messages to reinforce topics and skills covered in the workshop. Affective symptoms decreased significantly and to the same extent in all 3 conditions. At the end of treatment, 33% to 58% of participants reported levels of depressive symptoms in the normal range, and 50% to 58% reported nonclinical levels of anxiety. Compared to CBT and PI Therapy, PI Therapy + Supps was associated with significantly greater improvements in sleep quality. These findings suggest that a brief integrative intervention with or without supplements was comparable to CBT in reducing affective symptoms in adults with depression and/or anxiety. However, sleep quality improved only in the PI Therapy + Supps condition. These findings will require replication with a larger cohort.",2020,Affective symptoms decreased significantly and to the same extent in all 3 conditions.,"['adult depression and/or anxiety', 'adults with depression and/or anxiety', '48 adults with depression and/or anxiety', 'Adults With Depression and/or Anxiety']","['CBT', 'integrative intervention, Personalized Integrative Therapy (PI Therapy', 'PI Therapy delivered alone or with nutritional supplements (PI Therapy + Supps', 'Brief Integrative Treatment', 'cognitive behavior therapy (CBT']","['levels of depressive symptoms', 'affective symptoms', 'nonclinical levels of anxiety', 'Affective symptoms', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",48.0,0.0323079,Affective symptoms decreased significantly and to the same extent in all 3 conditions.,"[{'ForeName': 'Adrian L', 'Initials': 'AL', 'LastName': 'Lopresti', 'Affiliation': 'Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Metse', 'Affiliation': 'Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Foster', 'Affiliation': 'Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': 'Murdoch University, Perth, Western Australia, Australia.'}]",Journal of evidence-based integrative medicine,['10.1177/2515690X20937997']
2178,32638662,Effects of subcutaneous esketamine on blood pressure and heart rate in treatment-resistant depression.,"INTRODUCTION AND OBJECTIVES


The impact of multiple subcutaneous (s.c.) esketamine injections on the blood pressure (BP) and heart rate (HR) of patients with unipolar and bipolar treatment-resistant depression (TRD) is poorly understood. This study aimed to assess the cardiovascular safety of multiple s.c. doses of esketamine in patients with TRD.
METHODS


Seventy TRD patients received 394 weekly s.c. esketamine injections in conjunction with oral antidepressant therapy for up to six weeks. Weekly esketamine doses were 0.5, 0.75 or 1.0 mg/kg according to each patient's response to treatment. Participants were monitored before each treatment and every 15 minutes thereafter for 120 minutes. We assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR measurements for the entire treatment course.
RESULTS


BP increased after the first s.c. esketamine injection, reaching maximum mean SBP/DBP levels of 4.87/5.54 mmHg within 30-45 minutes. At the end of monitoring, 120 minutes post dose, vital signs returned to pretreatment levels. We did not detect significant differences in BP between doses of 0.5, 0.75, and 1 mg/kg esketamine. Mean HR did not differ significantly between doses or before and after s.c. esketamine injection.
CONCLUSIONS


The BP changes observed with repeated s.c. esketamine injections were mild and well tolerated for doses up to 1 mg/kg. The s.c. route is a simple and safe method of esketamine administration, even for patients with clinical comorbidities, including obesity, hypertension, diabetes, and dyslipidemia. However, 14/70 patients experienced treatment-emergent transient hypertension (SBP >180 mmHg and/or a DBP >110 mmHg). Therefore, we strongly recommend monitoring BP for 90 minutes after esketamine dosing. Since s.c. esketamine is cheap, requires less frequent dosing (once a week), and is a simpler procedure compared to intravenous infusions, it might have an impact on public health.",2020,"esketamine is cheap, requires less frequent dosing (once a week), and is a simpler procedure compared to intravenous infusions, it might have an impact on public health.","['patients with clinical comorbidities, including obesity, hypertension, diabetes, and dyslipidemia', 'patients with TRD', 'treatment-resistant depression', 'Seventy TRD patients received 394 weekly s.c', '14/70 patients experienced treatment-emergent transient hypertension (SBP >180\u2009mmHg and/or a DBP >110\u2009mmHg', 'patients with unipolar and bipolar treatment-resistant depression (TRD']","['multiple subcutaneous (s.c.) esketamine injections', 'esketamine', 'esketamine injection', 'subcutaneous esketamine', 'esketamine injections']","['blood pressure (BP) and heart rate (HR', 'mild and well tolerated', 'esketamine injection, reaching maximum mean SBP/DBP levels', 'blood pressure and heart rate', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR measurements', 'Mean HR', 'BP changes', 'cardiovascular safety', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0152170', 'cui_str': 'Transient hypertension'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.0307631,"esketamine is cheap, requires less frequent dosing (once a week), and is a simpler procedure compared to intravenous infusions, it might have an impact on public health.","[{'ForeName': 'Lorena Catarina', 'Initials': 'LC', 'LastName': 'Del Sant', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Luciana Maria', 'Initials': 'LM', 'LastName': 'Sarin', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo Jorge Muniz', 'Initials': 'EJM', 'LastName': 'Magalhães', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana Cecília', 'Initials': 'AC', 'LastName': 'Lucchese', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurélio', 'Initials': 'MA', 'LastName': 'Tuena', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Nakahira', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Victor Augusto Rodovalho', 'Initials': 'VAR', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Delfino', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Surjan', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Matheus Souza', 'Initials': 'MS', 'LastName': 'Steiglich', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbosa', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Abdo', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Frederico Molina', 'Initials': 'FM', 'LastName': 'Cohrs', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Aroldo', 'Initials': 'A', 'LastName': 'Liberatori', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'Del Porto', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Acioly Luiz Tavares', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jair', 'Initials': 'J', 'LastName': 'de Jesus Mari', 'Affiliation': 'Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922955']
2179,32639099,Ex vivo-expanded autologous adipose tissue-derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial.,"Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor-blinded clinical trial comparing fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC-enriched fat grafts (≥20 × 10 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture-expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.clinicaltrials.gov, number H-16046960.",2020,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"['plastic surgery', 'breast augmentation']","['ASC-enriched fat grafts (≥20\u2009×\u200910 6  viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts', 'Autologous fat grafting and implant surgery', 'fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs', 'Ex vivo-expanded autologous adipose tissue-derived stromal cells']","['retention rates', 'Volume retention']","[{'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]","[{'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0761152,ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%).,"[{'ForeName': 'Stig-Frederik T', 'Initials': 'ST', 'LastName': 'Kølle', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Duscher', 'Affiliation': 'Department of Plastic and Hand Surgery, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Taudorf', 'Affiliation': 'Department of Radiology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fischer-Nielsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Jesper D', 'Initials': 'JD', 'LastName': 'Svalgaard', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Munthe-Fog', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jønsson', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Selvig', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Frederik P', 'Initials': 'FP', 'LastName': 'Mamsen', 'Affiliation': 'Department of Stem Cell Research, Stemform, Copenhagen, Denmark.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Katz', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",Stem cells translational medicine,['10.1002/sctm.20-0081']
2180,32639170,The Feasibility and Acceptability of the Developing Real Incentives and Volition for Exercise (DRIVE) Program: A Pilot Study for Promoting Physical Activity in African American Women.,"Background . The purpose of the current article is to demonstrate how formative process evaluation was used in a pilot study to optimize the design and implementation of two motivationally targeted community-based physical activity (PA) interventions for inactive African American women.  Method . Fifteen African American women (M age: 41.6 years) were randomized to a challenge-focused program targeted toward high autonomous motivation or a rewards-focused program targeted toward low autonomous motivation. The challenge-focused program targeted enjoyment and valuation of PA and a team-based positive social climate through competitive intergroup activities and team-based goals, whereas the rewards-focused program targeted PA interest, competency, and partner-based social support through a walking program, individual-based goals with financial incentives, and partner-based action-plans.  Results . Feedback from participants revealed high levels of acceptability of essential elements. Average weekly attendance exceeded the a priori goal of ≥75% of members in attendance each week. External systematic observation demonstrated that session content dose was ≥93% in both programs. Facilitator-level fidelity exceeded the a priori goal of averaging ≥3 on a 4-point scale for behavioral skills, communication, autonomy support, and session content. The process evaluation also revealed areas for improvement, including facilitator-level social support and behavioral skills at the group-level. Process data collected through FitBits revealed that participants were engaged in self-monitoring PA during the 6-week programs.  Conclusions . The formative process evaluation demonstrated adequate levels of feasibility and acceptability and also provided key insights into adjustments needed before proceeding with implementing the motivationally targeted group-based programs in a larger randomized study.",2020,"Facilitator-level fidelity exceeded the a priori goal of averaging ≥3 on a 4-point scale for behavioral skills, communication, autonomy support, and session content.","['Fifteen African American women (M age: 41.6 years', 'African American Women', 'Program', 'inactive African American women']","['PA and a team-based positive social climate through competitive intergroup activities and team-based goals, whereas the rewards-focused program targeted PA interest, competency, and partner-based social support through a walking program, individual-based goals with financial incentives, and partner-based action-plans', 'Developing Real Incentives and Volition for Exercise (DRIVE', 'challenge-focused program targeted toward high autonomous motivation or a rewards-focused program targeted toward low autonomous motivation', 'two motivationally targeted community-based physical activity (PA) interventions']","['Average weekly attendance', 'acceptability of essential elements', 'Facilitator-level fidelity', 'facilitator-level social support and behavioral skills']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",15.0,0.0141095,"Facilitator-level fidelity exceeded the a priori goal of averaging ≥3 on a 4-point scale for behavioral skills, communication, autonomy support, and session content.","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Sweeney', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zarrett', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}]",Health promotion practice,['10.1177/1524839920939572']
2181,32639235,"Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Trial.","INTRODUCTION


Previous, small studies have suggested that ondansetron has beneficial effects in diarrhea-predominant irritable bowel syndrome (IBS-D). This randomized, double-blind study evaluated the efficacy and safety of daily 12 mg RHB-102, an investigational bimodal release ondansetron tablet, in IBS-D.
METHODS


Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10 were randomized 60:40 to RHB-102 or placebo once daily for 8 weeks. The primary end point was overall stool consistency response for at least 4 of 8 weeks. Secondary end points included overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points.
RESULTS


Overall stool consistency response rates were 56.0% and 35.3% (RHB-102 vs placebo, P = 0.036) and similar among male and female patients. Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant. Stool consistency response rates were enhanced in patients with baseline C-reactive protein above the median (2.09 mg/L), 59.5%, vs 23.1% (P = 0.009). Overall rates of adverse events were similar, with a higher rate of constipation in RHB-102 patients (13.3% vs 3.9%) that resolved rapidly on withholding treatment.
DISCUSSION


RHB-102 was effective and safe in the treatment of men and women with IBS-D. Baseline C-reactive protein seemed to be predictive of response.",2020,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","['Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10', 'Diarrhea-Predominant Irritable Bowel Syndrome']","['RHB-102', 'RHB-102 or placebo', 'Bimodal Release Ondansetron', 'daily 12 mg RHB-102', 'ondansetron']","['Stool consistency response rates', 'Stool Consistency and Symptomatology', 'effective and safe', 'rate of constipation', 'Overall pain response', 'efficacy and safety', 'overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points', 'composite response rates', 'Overall rates of adverse events', 'overall stool consistency response', 'Overall stool consistency response rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.720687,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","[{'ForeName': 'Terry F', 'Initials': 'TF', 'LastName': 'Plasse', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Arkansas Gastroenterology, PA, North Little Rock Arkansas, USA.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'New Phase Research & Development, Knoxville, Tennessee, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Abramson', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Kalfus', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Raday', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Harris', 'Affiliation': 'Middleburg Consultants, Takoma Park, Maryland, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000727']
2182,32633995,Learning person-centred consultation skills in clinical medicine: A randomised controlled case study.,"BACKGROUND


Training institutions need to ensure that healthcare students learn the skills to conduct person-centred consultations. We studied changes in person-centred practice over time following a quality improvement (QI) intervention among Bachelor of Clinical Medical Practice undergraduate students.
METHODS


Students were randomised to intervention and control groups. The intervention group received training and did a QI cycle on their own consultation skills. Consultations with simulated patients were recorded during structured clinical examinations in June (baseline) and November (post-intervention) 2015.
RESULTS


Matched consultations for 64 students were analysed. The total SEGUE (Set the stage, Elicit information, Give information, Understand the patient's perspective and End the encounter scores) were significantly higher in the final assessment compared to baseline for both the whole group and the intervention group (p = 0.005 and 0.015, respectively). The improvement did not differ significantly between intervention and control groups (p = 0.778). Third-year students improved significantly more than second years (p = 0.007).
CONCLUSION


The person-centred practice (including collaboration) of clinical associate students did improve over the period studied. The results show that students' learning of person-centred practice also happened in ways other than through the QI intervention. There is a need to develop students' collaborative skills during the medical consultation.",2020,The results show that students' learning of person-centred practice also happened in ways other than through the QI intervention.,"['Students', 'clinical medicine', 'Bachelor of Clinical Medical Practice undergraduate students', '64 students']","['training and did a QI cycle on their own consultation skills', 'Learning person-centred consultation skills', 'quality improvement (QI) intervention']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008964', 'cui_str': 'Medicine, Clinical'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],64.0,0.0424012,The results show that students' learning of person-centred practice also happened in ways other than through the QI intervention.,"[{'ForeName': 'Jakobus M', 'Initials': 'JM', 'LastName': 'Louw', 'Affiliation': 'Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria. murray.louw@up.ac.za.'}, {'ForeName': 'Johannes F M', 'Initials': 'JFM', 'LastName': 'Hugo', 'Affiliation': ''}]",South African family practice : official journal of the South African Academy of Family Practice/Primary Care,['10.4102/safp.v62i1.5109']
2183,32634052,A randomized controlled trial to compare group motivational interviewing to very brief advice for the effectiveness of a workplace smoking cessation counseling intervention.,"BACKGROUND


Studies show that smokers have a lower work performance due to time spent smoking, increased fatigue perception and are more absent from work due to smoking-related diseases. The workplace could represent an important location to promote smoking cessation.
METHODS


This study is a multi-center, controlled trial for smoking cessation counseling at the participants' workplace, where 656 randomized participants received four sessions of group motivational interviewing or four sessions of very brief advice and were followed up for 52 weeks.
RESULTS


The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks 9 to 24 (13.4% vs. 3.4%) and weeks 9 to 52 (10.3% vs. 3.1%).
CONCLUSIONS


This study demonstrated that motivational interviewing is an efficacious smoking cessation approach for smokers at their workplace. The short-term and long-term cessation rate of the intervention of the smoking cessation counseling group exceeded that of very brief advice.",2020,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,['smokers at their workplace'],"['workplace smoking cessation counseling intervention', 'motivational interviewing', 'smoking cessation counseling']",['Continuous Quit Rate (CQR'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}]",656.0,0.0260156,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Floresta', 'Affiliation': 'Health and Safety Manager of Eurospin Sicily and Calabria, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Ledda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Vitale', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Venerando', 'Initials': 'V', 'LastName': 'Rapisarda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1782564']
2184,32639892,Thiazide Use and Decreased Risk of Heart Failure in Nondiabetic Patients Receiving Intensive Blood Pressure Treatment.,"The SPRINT (Systolic Blood Pressure Intervention Trial) study reported that intensive blood pressure (BP) treatment with a systolic BP target of <120 mm Hg decreased the risks of cardiovascular events. However, it remains unknown whether specific medications can further improve cardiovascular outcome in patients receiving intensive BP treatment. This study examined whether thiazide use improves cardiovascular outcome in patients receiving intensive BP treatment. We used data of nondiabetic patients receiving intensive BP treatment in the SPRINT study. The primary outcome was a composite end point of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death. We analyzed hazard ratios for outcomes with 95% CIs in patients taking thiazides compared with those not taking thiazides using Cox proportional hazard models. This study included 2847 patients and the mean follow-up period was 3.3 years. The risk of primary outcome events was significantly lower in patients taking thiazides than in those not taking thiazides in both entire and propensity score-matched cohorts. Particularly, heart failure risk was significantly lower in those taking thiazides. These associations were also observed in various subgroups. In addition, thiazide use was associated with decreased risk of all-cause mortality. Hypokalemia occurred more frequently in patients taking thiazides than in those not taking thiazides. Thiazide use decreased risk of cardiovascular events, particularly heart failure, in nondiabetic high-risk patients receiving intensive BP treatment.",2020,The risk of primary outcome events was significantly lower in patients taking thiazides than in those not taking thiazides in both entire and propensity score-matched cohorts.,"['nondiabetic high-risk patients receiving intensive BP treatment', 'patients receiving intensive BP treatment', 'nondiabetic patients receiving intensive BP treatment in the SPRINT study', 'Nondiabetic Patients Receiving Intensive Blood Pressure Treatment', '2847 patients and the mean follow-up period was 3.3 years']","['thiazide', 'Thiazide', 'intensive blood pressure (BP) treatment with a systolic BP target of <120 mm']","['Risk of Heart Failure', 'Hypokalemia', 'risk of cardiovascular events', 'cardiovascular outcome', 'risk of all-cause mortality', 'heart failure risk', 'risks of cardiovascular events', 'composite end point of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2847.0,0.0364217,The risk of primary outcome events was significantly lower in patients taking thiazides than in those not taking thiazides in both entire and propensity score-matched cohorts.,"[{'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'From the Department of Diabetes and Endocrinology, Toranomon Hospital Kajigaya, Kanagawa, Japan (T.T.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kajio', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Center Hospital, National Center for Global Health and Medicine, Tokyo, Japan (T.T., H.K.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15154']
2185,32639946,A validated survival nomogram for early-onset diffuse gastric cancer.,"This study aimed to establish and independently validate a prognostic nomogram for individual risk prediction in patients with early-onset diffuse gastric cancer (EODGC). Data for 794 patients with EODGC from the SEER database were randomly assigned to training (N=558) and internal validation (N=236) sets, and data for 82 patients from the Renmin Hospital of Wuhan University (RMHWHU) were used as an independent validation cohort. Our LASSO regression analyses of the training set yielded five clinicopathological features (race, AJCC stage, surgery for primary site, chemotherapy and tumor size), which were used to create a survival nomogram. Our survival nomogram achieved better predictive performance than the AJCC staging system, the current standard. Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values. Indeed, our nomogram, which estimates individualized survival probabilities for patients with EODGC, shows good predictive accuracy and calibration ability for both the SEER and RMHWHU cohorts. These results suggest that a survival nomogram may be better at predicting OS for EODGC patients than the AJCC staging system.",2020,"Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values.","['82 patients from the Renmin Hospital of Wuhan University (RMHWHU) were used as an independent validation cohort', '794 patients with EODGC from the SEER database', 'early-onset diffuse gastric cancer', 'patients with early-onset diffuse gastric cancer (EODGC']",[],"['survival probabilities', 'individualized survival probabilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",794.0,0.0291444,"Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}]",Aging,['10.18632/aging.103406']
2186,32640027,Serum VEGF predicts clinical improvement induced by Cerebrolysin plus donepezil in patients with advanced Alzheimer's disease.,"Serum vascular endothelial growth factor (VEGF) increases with Alzheimer's disease (AD) severity and may prevent cognitive decline. However, information on the influence of AD drug therapy on circulating VEGF is limited. This study assessed changes in serum VEGF levels and its association with clinical and functional responses in mild to moderate AD patients who were treated with Cerebrolysin, donepezil, or the combined therapy in a randomized, controlled trial (RCT). Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels, and improved functioning and cognition significantly compared to donepezil alone in patients with advanced AD; and treatment differences were more pronounced in patients with higher VEGF levels. Our results indicate that the combined therapy reversed the increase of serum VEGF in advanced AD, which was associated with cognitive and functional responses, particularly in patients with high baseline VEGF.",2020,"Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels, and improved functioning and cognition significantly compared to donepezil alone in patients with advanced AD; and treatment differences were more pronounced in patients with higher VEGF levels.","[""patients with advanced Alzheimer's disease"", 'mild to moderate AD patients who were treated with', 'patients with advanced AD']","['Cerebrolysin plus donepezil', 'donepezil', 'Cerebrolysin, donepezil, or the combined therapy']","['serum VEGF in advanced AD', 'elevated serum VEGF levels', 'cognitive and functional responses', 'serum VEGF levels', 'functioning and cognition', 'Serum vascular endothelial growth factor (VEGF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0055108', 'cui_str': 'cerebrolysin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0398602,"Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels, and improved functioning and cognition significantly compared to donepezil alone in patients with advanced AD; and treatment differences were more pronounced in patients with higher VEGF levels.","[{'ForeName': 'X Anton', 'Initials': 'XA', 'LastName': 'Alvarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Alvarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Antia', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Complexo Hospitalario Universitario de Ourense, Ourense, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Romero', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Concha', 'Initials': 'C', 'LastName': 'Benito', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Suarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mourente', 'Affiliation': 'Hospital Quirónsalud, A Coruña, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fantini', 'Affiliation': 'Hospital HM Modelo, A Coruña, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Aleixandre', 'Affiliation': 'School of Psychology, Granada University, Granada, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Linares', 'Affiliation': 'Complejo Asistencial HHSCJ, Málaga, Spain.'}, {'ForeName': 'Dafin', 'Initials': 'D', 'LastName': 'Muresanu', 'Affiliation': 'Department of Clinical Neurosciences, University of Medicine and Pharmacy ""Iuliu Hațieganu"", Cluj-Napoca, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'Ever NeuroPharma, Unterach, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Moessler', 'Affiliation': 'Comamo OG, Mondsee, Austria.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa046']
2187,32640028,Improving Decision-making in Empiric Antibiotic Selection (IDEAS) for Gram-negative Bacteremia: A Prospective Clinical Implementation Study.,"BACKGROUND


Timely selection of adequate empiric antibiotics has become increasingly difficult due to rising resistance rates and the competing desire to apply antimicrobial stewardship (AMS) principles. Individualized clinical prediction models offer the promise of both reducing broad-spectrum antibiotic use and preserving/improving adequacy of treatment, but few have been validated in the clinical setting.
METHODS


Multivariable models were used to predict the probability of susceptibility for Gram-negative (GN) bacteria in blood-stream infections (bacteremia) to ceftriaxone, ciprofloxacin, ceftazidime, piperacillin-tazobactam and meropenem. The models were combined with existing resistance prediction methods to generate optimized and individualized suggestions for empiric therapy that were provided to prescribers by an AMS pharmacist. De-escalation of empiric antibiotics and adequacy of therapy were analyzed using a quasi-experimental design comparing two 9-month periods (pre and post-intervention) at a large academic tertiary care institution.
RESULTS


Episodes of bacteremia (n=182) were identified in the pre-intervention and post-intervention (n=201) periods. Patients who received the intervention were more likely to have their therapy de-escalated (29 vs 21%, aOR=1.77, 95%CI 1.09-2.87, p=0.02). The intervention also increased the proportion of patients who were on the narrowest adequate therapy at the time of culture finalization (44% in the control group and 55% in the intervention group; aOR=2.04, 95%CI 1.27-3.27, p=0.003). Time to adequate therapy was similar in the intervention and control groups (5 vs 4 hours; p=0.95).
CONCLUSIONS


An AMS intervention, based on individualized predictive models for resistance, can influence empiric antibiotic selections for GN bacteremia to facilitate early de-escalation of therapy without compromising adequacy of antibiotic coverage.",2020,"Time to adequate therapy was similar in the intervention and control groups (5 vs 4 hours; p=0.95).
",['Gram-negative Bacteremia'],"['ceftriaxone, ciprofloxacin, ceftazidime, piperacillin-tazobactam and meropenem']","['probability of susceptibility for Gram-negative (GN) bacteria in blood-stream infections (bacteremia', 'Time to adequate therapy']","[{'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",182.0,0.0420331,"Time to adequate therapy was similar in the intervention and control groups (5 vs 4 hours; p=0.95).
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Elligsen', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care and Population Health, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Jerome A', 'Initials': 'JA', 'LastName': 'Leis', 'Affiliation': 'Division of Infectious Diseases, University of Toronto,\xa0Canada.'}, {'ForeName': 'Sandra A N', 'Initials': 'SAN', 'LastName': 'Walker', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases, University of Toronto,\xa0Canada.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'MacFadden', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa921']
2188,32640097,Use of vibrating anesthetic device reduces the pain of mesotherapy injections: A randomized split-scalp study.,"Pain evaluation during local injections is a complex process. Injections cause patient's distress, especially when the target is a sensitive area such as scalp. Nonpharmacological methods as vibration before and during the procedure have been used to reduce pain. Mesotherapy has become a popular nonsurgical procedure for nonscarring alopecia, such as androgenetic alopecia (AGA) and alopecia areata (AA). Vibration has been successfully used in dermatological procedures, pediatrics, and dentistry. No study was found on vibration anesthesia during scalp mesotherapy. To analyze the effect of a vibration anesthetic device (VAD) during scalp mesotherapy on the patients' comfort.This is a randomized split-scalp study; thirty patients received mesotherapy with or without VAD on half of their scalp. Numerical rating scale (NRS) was used to measure self-reported pain. To test difference in means and medians in comparing device use and by treatment (AGA or AA), Student's t tests and Wilcoxon signed rank tests were used. Overall mean pain score on the no vibration-assisted side was 8.0 ± 1.0 while pain score for the vibration side was 2.3 ± 1.5, for AGA (P < .001) and 7.4 ± 1.2 and 2.1 ± 1.3, respectively, for AA (P < .001). Findings were similar for medians. No complications were found following procedure. To the best of our knowledge, this is the first study analyzing the effect of VAD in patients undergoing scalp mesotherapy. The VAD technique was found to be safe, effective, simple, and suitable for scalp procedures.",2020,No complications were found following procedure.,['patients undergoing scalp mesotherapy'],"['vibrating anesthetic device', 'VAD', 'mesotherapy with or without VAD', 'vibration anesthetic device (VAD', 'Mesotherapy']","['Overall mean pain score', 'pain of mesotherapy injections', 'vibration anesthesia', 'Numerical rating scale (NRS', 'pain score', 'Pain evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",30.0,0.0201634,No complications were found following procedure.,"[{'ForeName': 'Raquel de Melo', 'Initials': 'RM', 'LastName': 'Carvalho', 'Affiliation': 'Dermatology Department, Marcílio Dias Naval Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Taynara de Mattos', 'Initials': 'TM', 'LastName': 'Barreto', 'Affiliation': 'Dermatology Department, Bonsucesso Federal Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Weffort', 'Affiliation': 'University of State of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Carla Jorge', 'Initials': 'CJ', 'LastName': 'Machado', 'Affiliation': 'Preventive and Social Medicine Department, Federal University of Minas Gerais, Minas Gerais, Brazil.'}, {'ForeName': 'Daniel Fernandes', 'Initials': 'DF', 'LastName': 'Melo', 'Affiliation': 'University of State of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13554']
2189,32640112,Combined strategies following surgical drainage for perianal fistulising crohn's disease: Failure rates and prognostic factors.,"PURPOSE


The medico-surgical strategy for the treatment of perianal fistulising Crohn's disease following surgical drainage remains challenging and debated. The aims were to describe the failure rate of therapeutic interventions after drainage of the fistula tract and to determine the factors associated with failure to optimize medico-surgical strategies.
METHODS


All consecutive patients with perianal fistulising CD who underwent surgical drainage with at least a 12-week follow-up were included. Failure was defined as the occurrence of at least one of the following items: abscess recurrence, purulent discharge from the tract, visible external opening, and further drainage procedure.
RESULTS


One hundred sixty-nine patients were included. The median follow-up was 4.0 years. The cumulative failure rates were 20%, 30% and 36% at 1, 3 and 5 years, respectively. The cumulative failure rates in patients who had sphincter-sparing surgeries or seton removal were significantly higher than those who had a fistulotomy. Anterior fistula (HR = 2.52 [1.13-5.61], p=0.024), supralevator extension (HR = 20.78 [3.38-127.80], p=0.001) and the absence or discontinuation of immunosuppressants after anal drainage (HR = 3.74 [1.11-12.5], p=0.032) were significantly associated with failure in the multivariate analysis model.
CONCLUSIONS


Combined strategies for perianal fistulising CD lead to failure rate of 36% at 5 years. Where advisable, fistulotomy may be preferred because it has a lower rate of recurrence. The benefits of immunosuppressants require a dedicated prospective randomized trial.",2020,"Anterior fistula (HR = 2.52 [1.13-5.61], p=0.024), supralevator extension (HR = 20.78 [3.38-127.80], p=0.001) and the absence or discontinuation of immunosuppressants after anal drainage (HR = 3.74 [1.11-12.5], p=0.032) were significantly associated with failure in the multivariate analysis model.
","['One hundred sixty-nine patients were included', 'All consecutive patients with perianal fistulising CD who underwent surgical drainage with at least a 12-week follow-up were included']",[],"['supralevator extension', 'failure rate', 'cumulative failure rates', 'absence or discontinuation of immunosuppressants after anal drainage']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",169.0,0.0718637,"Anterior fistula (HR = 2.52 [1.13-5.61], p=0.024), supralevator extension (HR = 20.78 [3.38-127.80], p=0.001) and the absence or discontinuation of immunosuppressants after anal drainage (HR = 3.74 [1.11-12.5], p=0.032) were significantly associated with failure in the multivariate analysis model.
","[{'ForeName': 'Auguste', 'Initials': 'A', 'LastName': 'Herissay', 'Affiliation': 'CHU Rennes, Univ Rennes, F-35000, Rennes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Siproudhis', 'Affiliation': 'CHU Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolism and Cancer), F-35000, Rennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': ""Le Balc'h"", 'Affiliation': 'CHU Rennes, Univ Rennes, F-35000, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': ""Merlini L'heritier"", 'Affiliation': 'CHU Rennes, Univ Rennes, F-35000, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dewitte', 'Affiliation': 'CHU Rennes, Univ Rennes, F-35000, Rennes, France.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Wallenhorst', 'Affiliation': 'CHU Rennes, Univ Rennes, F-35000, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bouguen', 'Affiliation': 'CHU Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolism and Cancer), F-35000, Rennes, France.'}, {'ForeName': 'Charlène', 'Initials': 'C', 'LastName': 'Brochard', 'Affiliation': 'CHU Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolism and Cancer), F-35000, Rennes, France.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15241']
2190,32631074,"Utility of Neuromuscular Electrical Stimulation to Preserve Quadriceps Muscle Fiber Size and Contractility After Anterior Cruciate Ligament Injuries and Reconstruction: A Randomized, Sham-Controlled, Blinded Trial.","BACKGROUND


Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR) promote quadriceps muscle atrophy and weakness that can persist for years, suggesting the need for more effective rehabilitation programs. Whether neuromuscular electrical stimulation (NMES) can be used to prevent maladaptations in skeletal muscle size and function is unclear.
PURPOSE


To examine whether early NMES use, started soon after an injury and maintained through 3 weeks after surgery, can preserve quadriceps muscle size and contractile function at the cellular (ie, fiber) level in the injured versus noninjured leg of patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture were randomized to NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg. Bilateral biopsies of the vastus lateralis were performed 3 weeks after surgery to measure skeletal muscle fiber size and contractility. Quadriceps muscle size and strength were assessed 6 months after surgery.
RESULTS


A total of 21 patients (9 men/12 women) completed the trial. ACLR reduced single muscle fiber size and contractility across all fiber types ( P  < .01 to  P  < .001) in the injured compared with noninjured leg 3 weeks after surgery. NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001). NMES preserved contractility in slow-twitch MHC I fibers ( P  < .01 to  P  < .001), increasing maximal contractile velocity ( P  < .01) and preserving power output ( P  < .01), but not in MHC II fibers. Differences in whole muscle strength between groups were not discerned 6 months after surgery.
CONCLUSION


Early NMES use reduced skeletal muscle fiber atrophy in MHC II fibers and preserved contractility in MHC I fibers. These results provide seminal, cellular-level data demonstrating the utility of the early use of NMES to beneficially modify skeletal muscle maladaptations to ACLR.
CLINICAL RELEVANCE


Our results provide the first comprehensive, cellular-level evidence to show that the early use of NMES mitigates early skeletal muscle maladaptations to ACLR.
REGISTRATION


NCT02945553 (ClinicalTrials.gov identifier).",2020,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"['Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture', '21 patients (9 men/12 women) completed the trial', 'After Anterior Cruciate Ligament Injuries and Reconstruction']","['Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg']","['maximal contractile velocity', 'preserving power output', 'Quadriceps Muscle Fiber Size and Contractility', 'ACLR reduced single muscle fiber size and contractility', 'Quadriceps muscle size and strength', 'fast-twitch myosin heavy chain (MHC) II fibers', 'contractility in slow-twitch MHC', 'muscle fiber atrophy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0333751', 'cui_str': 'Muscle fiber atrophy'}]",21.0,0.154142,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Choquette', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Anair', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Failla', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapslaey', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'Endres', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Slauterbeck', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Beynnon', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}]",The American journal of sports medicine,['10.1177/0363546520933622']
2191,32631080,Impact of a mobile phone app on adherence to treatment regimens among hypertensive patients: A randomised clinical trial study.,"BACKGROUND


Hypertension is one of the most prevalent long-term diseases seen in many countries, including Palestine. Patients with poorly controlled blood pressure are more likely to develop several complications. Therefore; it is imperative to control their blood pressure by improving their adherence to the treatment regimen.
AIM


The objective of this study was to evaluate the impact of using a mobile phone app on the level of adherence to treatment regimens among hypertensive patients in the Gaza Strip.
METHODS AND RESULTS


This study used an experimental design with a pre and post-intervention assessment. Using the Hill-Bone compliance to high blood pressure therapy scale, 191 participants completed the study: 94 in the control group and 97 in the intervention group. The intervention group used a phone app which reminds participants to take their medication, reminding them about their follow-up appointments and sending educational information about hypertension management. After 3 months of intervention, the level of adherence to treatment was reassessed. Results showed that participants in both groups showed a significant improvement in adherence levels, with higher improvements in the intervention group in the total score as well as all three domain scores: adherence to medication, diet and keeping appointments.
CONCLUSION


The use of a mobile phone app resulted in improvements in adherence to hypertension treatment. Thus, this study confirms the potential effectiveness of mobile technology in improving treatment adherence in hypertension and an opportunity to reduce cardiovascular mortality and morbidity. However, wider adoption has to be accompanied by ongoing evaluation and integration in public health systems.",2020,"Results showed that participants in both groups showed a significant improvement in adherence levels, with higher improvements in the intervention group in the total score as well as all three domain scores: adherence to medication, diet and keeping appointments.
","['hypertensive patients', 'hypertensive patients in the Gaza Strip', '191 participants completed the study: 94 in the control group and 97 in the intervention group']","['mobile phone app', 'phone app which reminds participants to take their medication, reminding them about their follow-up appointments and sending educational information about hypertension management', 'mobile technology']","['adherence levels', 'level of adherence', 'adherence to hypertension treatment', 'cardiovascular mortality and morbidity']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017209', 'cui_str': 'Gaza Strip (Palestine)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",191.0,0.0340628,"Results showed that participants in both groups showed a significant improvement in adherence levels, with higher improvements in the intervention group in the total score as well as all three domain scores: adherence to medication, diet and keeping appointments.
","[{'ForeName': 'Nasser Ibrahim', 'Initials': 'NI', 'LastName': 'Abu-El-Noor', 'Affiliation': 'Faculty of Nursing, Islamic University of Gaza, Palestine.'}, {'ForeName': 'Yousef Ibrahim', 'Initials': 'YI', 'LastName': 'Aljeesh', 'Affiliation': 'Faculty of Nursing, Islamic University of Gaza, Palestine.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bottcher', 'Affiliation': 'Faculty of Nursing, Islamic University of Gaza, Palestine.'}, {'ForeName': 'Mysoon Khalil', 'Initials': 'MK', 'LastName': 'Abu-El-Noor', 'Affiliation': 'Faculty of Nursing, Islamic University of Gaza, Palestine.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120938235']
2192,32631081,Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM findings from the VIVID study.,"BACKGROUND


The VIVID study compared two methods of U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM).
METHODS


VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for 7 consecutive days on each of 3 occasions; prior to Weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SDw) of CGM glucose.
RESULTS


Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [ 8.1 mg/dL]) compared to the MDI group (47.0 to 45.8 [-0.4 mg/dL]; p=0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%, p<0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoints mean glucose or A1C.
CONCLUSIONS


In the VIVID CGM sub-study of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared to MDI. CSII also significantly increased TIR with no difference between groups.",2020,The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [ 8.1 mg/dL]) compared to the MDI group (47.0 to 45.8 [-0.4 mg/dL]; p=0.047).,"['VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12', 'people with type 2 diabetes (T2D) requiring high doses of insulin']","['U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI', 'U-500R by Pump or Injection: CGM']","['dL glucose', 'Glucose Variability and Time in Range in Type', 'glycemic variability (GV) and time in range (TIR', 'mean SDw of glucose']","[{'cui': 'C1268943', 'cui_str': 'Vivid color saturation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456683', 'cui_str': 'U/day'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",54.0,0.0718828,The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [ 8.1 mg/dL]) compared to the MDI group (47.0 to 45.8 [-0.4 mg/dL]; p=0.047).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes & Endocrinology, Austin, Texas, United States; tblevins@texasdiabetes.com.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Center, 1998 Hendersonville Rd, Asheville, North Carolina, United States, 28803; mountaindiabetes@msn.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodbard', 'Affiliation': 'Biomedical Informatics Consultants LLC, 10113 Bentcross Drive, Potomac, Maryland, United States, 20854-4721.'}, {'ForeName': 'Dana K', 'Initials': 'DK', 'LastName': 'Sindelar', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; sindelar_dana_kevin@lilly.com.'}, {'ForeName': 'Ludi', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; ludi.fan@lilly.com.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Ellinor', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; ellinor_kelly@lilly.com.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Ilag', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, United States, 46285; ILAG_LIZA_L@LILLY.COM.'}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'Insulet Corporation, 600 Technology Park Dr #200, Billerica, Massachusetts, United States, 01821; tly@insulet.com.'}, {'ForeName': 'Jennal', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States; johnson_jennal@lilly.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0030']
2193,32631089,Low-impact (compliant) flooring and staff injuries.,"Introduction:  Low impact flooring (LIF) has shown potential for reducing fall-related injuries for older people in residential care or hospital environments. However, the increased rolling resistance when moving equipment on these floors has raised concerns that staff injuries may increase. Methods:  LIF was trialled on one Older Persons Health ward for 2.5 years. Reported staff injuries were monitored during and following the trial. Numbers of staff injured on the LIF ward were compared with three other similar and adjacent OPH wards without LIF for the duration of the trial ('concurrent control' evaluation). At the trial conclusion the LIF ward moved to a different hospital that had standard flooring. This enabled a further 'during and after' evaluation where numbers of staff injured from the LIF ward during the trial were compared with those reported afterwards by the same ward staff without LIF. Results:  There was no difference in the numbers of staff injured in the LIF ward compared with the concurrent control wards (28 LIF vs 30 control;  p  = 0.44). The number of staff with injuries in the LIF ward also did not significantly alter when those staff moved to a new ward without LIF (45 after vs 28 before;  p  = 0.11). Conclusion:  There was no change in the numbers of staff with injuries during the LIF trial in an Older Persons Health ward. This small study suggests LIF appears safe for both patients and staff.Implications for rehabilitationFalls in hospital are common with patient injuries occurring in approximately 20-30% of falls.Low impact (compliant) flooring may reduce fall-related injuries in hospitals and residential care.Low impact flooring has an increased rolling resistance, which has the potential to increase staff injuries when moving equipment.This study found no change in the number of staff injured during a low impact flooring trial providing some reassurance that these floors are safe for staff.",2020,The number of staff with injuries in the LIF ward also did not significantly alter when those staff moved to a new ward without LIF (45 after vs 28 before;  p  = 0.11).,"['older people in residential care or hospital environments', 'Older Persons Health ward for 2.5\u2009years']","['Introduction:  Low impact flooring (LIF', 'LIF']","['numbers of staff with injuries', 'number of staff with injuries', 'numbers of staff']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0125606', 'cui_str': 'Cholinergic Differentiation Factor'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",,0.031965,The number of staff with injuries in the LIF ward also did not significantly alter when those staff moved to a new ward without LIF (45 after vs 28 before;  p  = 0.11).,"[{'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Hanger', 'Affiliation': 'Canterbury District Health Board, Geriatrician, Burwood Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Wilkinson', 'Affiliation': 'Canterbury District Health Board, Geriatrician, Burwood Hospital, Christchurch, New Zealand.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1786174']
2194,32631102,A cluster-randomised trial to evaluate an intervention to promote handwashing in rural Nigeria.,"Handwashing with soap at critical times helps prevent diarrhoeal diseases. Changing handwashing practices through behaviour change communication remains a challenge. This study designed and tested a scalable intervention to promote handwashing with soap. A cluster-randomised, controlled trial compared our intervention against standard practice. Subjects were men, women and children in 14 villages in Cross-River state, Nigeria. The primary outcome was the proportion of observed key events on which hands were washed with soap. Binomial regression analysis calculated prevalence differences between study arms. The intervention had minimal effect on the primary outcome (+2.4%, p = 0.096). The intervention was associated with increased frequency of handwashes without soap before food contact (+13%, p = 0.017). The intervention failed to produce significant changes in handwashing with soap at key times. The low dose delivered (two contact points) may have increased scalability at the cost of effectiveness, particularly in the challenging context of inconvenient water access.",2020,"The intervention had minimal effect on the primary outcome (+2.4%, p = 0.096).","['Subjects were men, women and children in 14 villages in Cross-River state, Nigeria', 'rural Nigeria']",[],"['handwashing with soap at key times', 'frequency of handwashes without soap before food contact', 'diarrhoeal diseases', 'proportion of observed key events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]",[],"[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0660822,"The intervention had minimal effect on the primary outcome (+2.4%, p = 0.096).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Biran', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Awe', 'Affiliation': 'United Purpose Nigeria , Calabar, Nigeria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Greenland', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Akabike', 'Affiliation': 'EpiAFRIC , Abuja, Nigeria.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chuktu', 'Affiliation': 'United Purpose Nigeria , Calabar, Nigeria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aunger', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Curtis', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schmidt', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine , London, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Van der Voorden', 'Affiliation': 'Technical Support Unit, Water Supply and Sanitation Collaborative Council , Geneva, Switzerland.'}]",International journal of environmental health research,['10.1080/09603123.2020.1788712']
2195,32631130,Augmenting Evidence-Based Care With a Texting Mobile Interventionist: A Pilot Randomized Controlled Trial.,"OBJECTIVE


This study aimed to evaluate the feasibility and clinical utility of training intensive psychiatric community care team members to serve as ""mobile interventionists"" who engage patients in recovery-oriented texting exchanges.
METHODS


A 3-month pilot randomized controlled trial was conducted to compare the mobile interventionist approach as an add-on to assertive community treatment (ACT) versus ACT alone. Participants were 49 individuals with serious mental illness (62% with schizophrenia/schizoaffective disorder, 24% with bipolar disorder, and 14% with depression). Clinical outcomes were evaluated at baseline, posttreatment, and 6-month follow-up, and satisfaction was evaluated posttreatment.
RESULTS


The intervention appeared feasible (95% of participants assigned to the mobile interventionist arm initiated the intervention, texting on 69% of possible days and averaging four messages per day), acceptable (91% reported satisfaction), and safe (no adverse events reported). Exploratory posttreatment clinical effect estimations suggested greater reductions in the severity of paranoid thoughts (Cohen's d=-0.61) and depression (d=-0.59) and improved illness management (d=0.31) and recovery (d=0.23) in the mobile interventionist group.
CONCLUSIONS


Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising. The findings are encouraging given the relative ease of training practitioners to serve as mobile interventionists, the low burden placed on patients and practitioners, and the simplicity of the technology. The technical resources are widely accessible to patients and practitioners, boding well for potential intervention scalability. When pandemics such as COVID-19 block the possibility of in-person patient-provider contact, evidence-based texting interventions can serve a crucial role in supporting continuity of care.",2020,"CONCLUSIONS


Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising.","['Participants were 49 individuals with serious mental illness (62% with schizophrenia/schizoaffective disorder, 24% with bipolar disorder, and 14% with depression']","['Texting Mobile Interventionist', 'assertive community treatment (ACT) versus ACT alone']","['6-month follow-up, and satisfaction', 'depression (d=-0.59) and improved illness management', 'severity of paranoid thoughts']","[{'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517465', 'cui_str': '0.59'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}]",49.0,0.186904,"CONCLUSIONS


Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising.","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hudenko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000239']
2196,32631142,Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.,"The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.",2020,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.",[],[],[],[],[],[],,0.0502379,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Melnick', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}]",Statistical methods in medical research,['10.1177/0962280220932962']
2197,32631152,Intradetrusor onabotulinumtoxinA injections ameliorate autonomic dysreflexia while improving lower urinary tract function and urinary incontinence-related quality of life in individuals with cervical and upper thoracic spinal cord injury.,"Pilot data of our phase IV clinical trial (pre/post study design) highlighted a beneficial effect of intradetrusor onabotulinumtoxinA (200 IU) injections to reduce autonomic dysreflexia (AD) in individuals with chronic spinal cord injury (SCI) at T6 or above. After trial completion, we assessed whether our primary expectation (i.e., decrease of AD severity in 50% of participants during urodynamics) was met. Secondary outcome measures were spontaneous AD in daily life, amelioration of AD and urinary incontinence-related quality of life (QoL). In addition, we conducted injury-level-dependent analysis, i.e., cervical and upper thoracic, to explore group-specific treatment efficacy. Post-treatment, AD severity decreased in 82% (28/34) of all participants during urodynamics and in 74% (25/34) in daily life assessed with 24-hour ambulatory blood pressure monitoring. Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced. Further, the treatment was well tolerated, with only minor complications [grade I (n=7) and II (n=7)] in accordance with the Clavien-Dindo classification recorded in 11 individuals (cervical n=9, upper thoracic n=2). Injury-level-dependent analysis revealed lower incidence (cervical n=15/23, upper thoracic n=6/11) and lesser severity [cervical p=0.009; upper thoracic p=0.06 (Pearson's r= -0.6, i.e. large effect size)] of AD during urodynamics. Furthermore, reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum storage detrusor pressure (all p<0.05) were found in both groups post-treatment. Intradetrusor onabotulinumtoxinA injections are an effective and safe second-line treatment option that ameliorates AD while improving lower urinary tract function and urinary incontinence-related QoL in individuals with cervical and upper thoracic SCI.",2020,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","['individuals with cervical and upper thoracic SCI', 'individuals with cervical and upper thoracic spinal cord injury', 'individuals with chronic spinal cord injury (SCI) at T6 or above']",['intradetrusor onabotulinumtoxinA (200 IU) injections'],"['AD severity', 'daily life assessed with 24-hour ambulatory blood pressure monitoring', 'autonomic dysreflexia (AD', 'cystometric capacity', 'reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum storage detrusor pressure', 'urinary tract function and urinary incontinence-related quality of life', 'urinary incontinence-related QoL', 'maximum storage detrusor pressure', 'spontaneous AD in daily life, amelioration of AD and urinary incontinence-related quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0228625', 'cui_str': 'Structure of upper thoracic spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0042031', 'cui_str': 'Urinary tract function'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",,0.20053,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'University of British Columbia, International Collaboration On Repair Discoveries (ICORD), 818 West 10th Avenue, Vancouver, British Columbia, Canada, V5Z 1M9; mwalter@icord.org.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Kran', 'Affiliation': 'University of British Columbia, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada; stephaniekran@gmail.com.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Ramirez', 'Affiliation': 'University of British Columbia, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada; aramirez@icord.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rapoport', 'Affiliation': 'The University of British Columbia, 8166, International Collaboration on Repair Discoveries (ICORD), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nigro', 'Affiliation': 'University of British Columbia, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Stothers', 'Affiliation': 'The University of British Columbia, 8166, International Collaboration on Repair Discoveries (ICORD), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kavanagh', 'Affiliation': 'The University of British Columbia, 8166, International Collaboration on Repair Discoveries (ICORD), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Krassioukov', 'Affiliation': 'ICORD/UBC, Medicine, 6270 University Blv., Vancouver, British Columbia, Canada, V6T 1Z4.'}]",Journal of neurotrauma,['10.1089/neu.2020.7115']
2198,32631157,Tenecteplase versus alteplase after acute ischemic stroke at high age.,"BACKGROUND


Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years.
METHODS


Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed.
RESULTS


Of the 273 patients ≥80 years included, mean age was 85.5 years. In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12).
CONCLUSION


No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT01949948).",2020,"No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65).","['patients with ischemic stroke, including patients ≥80 years', '≥80 years included, mean age was 85.5 years', 'patients ≥80 years were identified', '273 patients', 'Data from the Norwegian Tenecteplase Stroke Trial', 'patients ≥80 years']","['Alteplase', 'tenecteplase and alteplase', 'Tenecteplase versus alteplase']","['efficacy and safety', 'proportion of patients with excellent functional outcome', 'Death', 'frequency of symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",273.0,0.114169,"No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65).","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Thommessen', 'Affiliation': 'Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Næss', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logallo', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kvistad', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Waje-Andreassen', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Internal Medicine, Bærum Hospital, Drammen, Norway.'}, {'ForeName': 'Håkon', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Internal Medicine, Bærum Hospital, Drammen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Thomassen', 'Affiliation': 'Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Morten Rønning', 'Affiliation': 'Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020938306']
2199,32631305,Pressure Support Ventilation (PSV) versus Neurally Adjusted Ventilatory Assist (NAVA) in difficult to wean pediatric ARDS patients: a physiologic crossover study.,"BACKGROUND


Neurally adjusted ventilatory assist (NAVA) is an innovative mode for assisted ventilation that improves patient-ventilator interaction in children. The aim of this study was to assess the effects of patient-ventilator interaction comparing NAVA with pressure support ventilation (PSV) in patients difficult to wean from mechanical ventilation after moderate pediatric acute respiratory distress syndrome (PARDS).
METHODS


In this physiological crossover study, 12 patients admitted in the Pediatric Intensive Care Unit (PICU) with moderate PARDS failing up to 3 spontaneous breathing trials in less than 7 days, were enrolled. Patients underwent three study conditions lasting 1 h each: PSV1, NAVA and PSV2.
RESULTS


The Asynchrony Index (AI) was significantly reduced during the NAVA trial compared to both the PSV1 and PSV2 trials (p = 0.001). During the NAVA trial, the inspiratory and expiratory trigger delays were significantly shorter compared to those obtained during PSV1 and PSV2 trials (Delay trinsp p < 0.001, Delay trexp p = 0.013). These results explain the significantly longer Time sync  observed during the NAVA trial (p < 0.001). In terms of gas exchanges, PaO 2  value significantly improved in the NAVA trial with respect to the PSV trials (p < 0.02). The PaO 2 /FiO 2  ratio showed a significant improvement during the NAVA trial compared to both the PSV1 and PSV2 trials (p = 0.004).
CONCLUSIONS


In this specific PICU population, presenting difficulty in weaning after PARDS, NAVA was associated with a reduction of the AI and a significant improvement in oxygenation compared to PSV mode.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier: NCT04360590 ""Retrospectively registered"".",2020,"In terms of gas exchanges, PaO 2  value significantly improved in the NAVA trial with respect to the PSV trials (p < 0.02).","['wean pediatric ARDS patients', 'patients difficult to wean from mechanical ventilation after moderate pediatric acute respiratory distress syndrome (PARDS', '12 patients admitted in the Pediatric Intensive Care Unit (PICU) with moderate PARDS failing up to 3 spontaneous breathing trials in less than 7\u2009days, were enrolled', 'children']","['NAVA with pressure support ventilation (PSV', 'Pressure Support Ventilation (PSV) versus Neurally Adjusted Ventilatory Assist (NAVA', 'Neurally adjusted ventilatory assist (NAVA']","['Asynchrony Index (AI', 'inspiratory and expiratory trigger delays']","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]",12.0,0.118646,"In terms of gas exchanges, PaO 2  value significantly improved in the NAVA trial with respect to the PSV trials (p < 0.02).","[{'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Spinazzola', 'Affiliation': 'Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo F. Vito 1, 00168, Rome, Italy. spinazzolagiorgia@yahoo.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'De Luca', 'Affiliation': 'Division of Pediatric and Neonatal Critical Care, South Paris University Hospital, Medical Centers ""A. Beclere"" Assistance Publique-Hopitaux de Paris (APHP), Paris, France.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Chidini', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Anesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Ferrone', 'Affiliation': 'Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Piastra', 'Affiliation': 'Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo F. Vito 1, 00168, Rome, Italy.'}]",BMC pediatrics,['10.1186/s12887-020-02227-1']
2200,32631324,The value of social practice theory for implementation science: learning from a theory-based mixed methods process evaluation of a randomised controlled trial.,"BACKGROUND


Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science.
METHODS


Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation.
RESULTS


Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements.
CONCLUSION


The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice.
TRIAL REGISTRATION


ISRCTN, IISRCTN86234930 . Registered 13th November 2014.",2020,"The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low.","['216 trial participants', 'for heart failure', '19 people with heart failure and 17 caregivers at 4\u2009months and 12\u2009months after recruitment into the trial', 'people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF']","['12\u2009week home-based intervention to optimise self-care support', 'complex intervention']",[],"[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",[],,0.069737,"The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': ""Institute of Health Research, University of Exeter College of Medicine and Health, St Luke's Campus, Heavitree Road, Exeter, Devon, EX1 2LU, UK. J.Frost@exeter.ac.uk.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wingham', 'Affiliation': 'Primary Care Research Group, University of Exeter College of Medicine and Health, Exeter, Devon, EX1 2LU, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Britten', 'Affiliation': ""Institute of Health Research, University of Exeter College of Medicine and Health University of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'Psychology Applied to Health, School of Sport, Exercise and Rehabilitation, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'School of Psychological Sciences, Faculty of Medicine, Dentistry and Health Sciences, School of Psychological Sciences, University of Melbourne, Melbourne, VIC, 3010, Australia.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': ""Medical Statistics, Exeter Collaboration for Academic Primary Care, University of Exeter College of Medicine and Health, St Luke's Campus, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Dalal', 'Affiliation': 'University of Exeter College of Medicine and Health (Truro Campus), Knowledge Spa, Royal Cornwall Hospital, Truro, TR1 3HD, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': ""Health Services Research, Institute of Health Research, University of Exeter College of Medicine and Health, St Luke's Campus, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}]",BMC medical research methodology,['10.1186/s12874-020-01060-5']
2201,32631366,Prompting consumers to make healthier food choices in hospitals: a cluster randomised controlled trial.,"BACKGROUND


Hospitals in the UK offer snacks for sale to patients, staff and visitors. Despite the NHS's health promoting role, and tightening of regulations around which foods can be sold in hospitals, many snacks purchased in this setting are unhealthy. The present project tests the effectiveness of theory-based point of purchase prompts (PPPs; a form of cognitive nudge) designed to make it cognitively easier for consumers to compare available products and choose healthier options.
METHODS


Hospital shops in Scotland (n = 30) were recruited into a cluster randomised controlled trial to test whether a PPP could reduce the average calorie, fat and/or sugar content of purchased snacks. Inclusion criteria stated that eligible sites; sold food; were located in a hospital; and were accessible to staff, patients and visitors. The PPP intervention was a theory-based sign (tailored to the available range in each location) designed to cognitively simplify healthier snack choices by facilitating cross-product comparison. Shops were randomised to display PPPs (intervention; n = 15) or not (control; n = 15) using block randomisation controlling for shop size. Data on all snacks purchased from participating shops were obtained from retailers for a 12-week baseline and 12-week follow-up period. Primary outcomes were the average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day. Secondary outcomes were the average customer spend per item purchased (£,p) and the total number of snacks purchased daily. Shop staff were not blinded to group assignment but data providers were. Data were analysed using mixed effects multi-level regression models.
RESULTS


Data from > 1 million snack purchases were analysed. Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control. Average spend per item also reduced significantly in intervention (but not control) sites (γ = - 0.89, p < .001). The intervention had no effect on the fat content of snacks or the number of snacks sold.
CONCLUSIONS


Simple, theory-based point of purchase prompts can produce small but statistically significant reductions in the energy content of snack purchases from hospital shops.
TRIAL REGISTRATION


Retrospectively registered (8/Oct/2018) with ISRCTN (ID: ISRCTN90365793 ).",2020,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","['hospitals', 'Hospital shops in Scotland (n\u2009=\u200930']","['display PPPs (intervention; n\u2009=\u200915) or not (control; n\u2009=\u200915) using block randomisation controlling for shop size', 'PPP', 'PPP intervention', 'theory-based point of purchase prompts (PPPs']","['average customer spend per item purchased (£,p) and the total number of snacks purchased daily', 'average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day', 'fat content of snacks or the number of snacks sold']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019987', 'cui_str': 'Hospital Shop'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C2742135', 'cui_str': 'SELL protein, human'}]",30.0,0.0862335,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Allan', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland. j.allan@abdn.ac.uk.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Powell', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00990-z']
2202,32631387,Transcutaneous electrical acupuncture stimulation (TEAS) for gastrointestinal dysfunction in adults undergoing abdominal surgery: study protocol for a prospective randomized controlled trial.,"BACKGROUND


Postoperative gastrointestinal (GI) dysfunction (PGD) is a common problem after abdominal surgery. PGD can increase the length of hospital stay and may lead to serious complications. Acupuncture and moxibustion are alternative therapies for PGD that have been used in some settings. However, the effect of preventive application of acupuncture or transcutaneous electrical acupuncture stimulation (TEAS) is still uncertain. The purpose of this study is to investigate the efficacy of the continuous application of TEAS on GI function recovery in adults undergoing abdominal surgery. At the same time, we will try to confirm the mechanism of TEAS through the brain-gut axis.
METHODS/DESIGN


This study is a prospective, single-center, two-arm, randomized controlled trial that will be performed in a general hospital. In total, 280 patients undergoing abdominal surgery were stratified by type of surgery (i.e. gastric or colorectal procedure) and randomized into two treatment groups. The experimental group will receive TEAS stimulation at L14 and PC6, ST36 and ST37. The sham group will receive pseudo-TEAS at sham acupoints. The primary outcome will be the time to the first bowel motion by auscultation. The recovery time of flatus, defecation, the changes in perioperative brain-intestinal peptides, postoperative pain, perioperative complications, and hospitalization duration will be the secondary outcomes.
DISCUSSION


The results of this study will demonstrate that continuous preventive application of TEAS can improve the GI function recovery in patients undergoing abdominal surgery and that this effect may act through brain-gut peptides.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900023263 . Registered on 11 May 2019.",2020,"The recovery time of flatus, defecation, the changes in perioperative brain-intestinal peptides, postoperative pain, perioperative complications, and hospitalization duration will be the secondary outcomes.
","['280 patients undergoing abdominal surgery were stratified by type of surgery (i.e. gastric or colorectal procedure', 'adults undergoing abdominal surgery', 'patients undergoing abdominal surgery']","['acupuncture or transcutaneous electrical acupuncture stimulation (TEAS', 'pseudo-TEAS', 'TEAS stimulation at L14 and PC6, ST36 and ST37', 'Transcutaneous electrical acupuncture stimulation (TEAS', 'Acupuncture and moxibustion', 'TEAS']","['length of hospital stay', 'GI function recovery', 'time to the first bowel motion by auscultation', 'recovery time of flatus, defecation, the changes in perioperative brain-intestinal peptides, postoperative pain, perioperative complications, and hospitalization duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450534', 'cui_str': 'ST37'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",280.0,0.221433,"The recovery time of flatus, defecation, the changes in perioperative brain-intestinal peptides, postoperative pain, perioperative complications, and hospitalization duration will be the secondary outcomes.
","[{'ForeName': 'Ya-Fan', 'Initials': 'YF', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Beijing Huimin Hospital, Beijing, China.'}, {'ForeName': 'Wen-Jing', 'Initials': 'WJ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China. anlixin8120@163.com.'}]",Trials,['10.1186/s13063-020-04470-4']
2203,32631414,Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial.,"BACKGROUND


Obese patients undergoing general anesthesia and mechanical ventilation during laparoscopic abdominal surgery commonly have a higher incidence of postoperative pulmonary complications (PPCs), due to factors such as decreasing oxygen reserve, declining functional residual capacity, and reducing lung compliance. Pulmonary atelectasis caused by pneumoperitoneum and mechanical ventilation is further aggravated in obese patients. Recent studies demonstrated that individualized positive end-expiratory pressure (iPEEP) was one of effective lung-protective ventilation strategies. However, there is still no exact method to determine the best iPEEP, especially for obese patients. Here, we will use the best static lung compliance (Cstat) method to determine iPEEP, compared with regular PEEP, by observing the atelectasis area measured by electrical impedance tomography (EIT), and try to prove a better iPEEP setting method for obese patients.
METHODS


This study is a single-center, two-arm, prospective, randomized control trial. A total number of 80 obese patients with body mass index ≥ 32.5 kg/m 2  scheduled for laparoscopic gastric volume reduction and at medium to high risk for PPCs will be enrolled. They will be randomly assigned to control group (PEEP5 group) and iPEEP group. A PEEP of 5 cmH 2 O will be used in PEEP5 group, whereas an individualized PEEP value determined by a Cstat-directed PEEP titration procedure will be applied in the iPEEP group. Standard lung-protective ventilation methods such as low tidal volumes (7 ml/kg, predicted body weight, PBW), a fraction of inspired oxygen ≥ 0.5, and recruitment maneuvers (RM) will be applied during and after operation in both groups. Primary endpoints will be postoperative atelectasis measured by chest electrical impedance tomography (EIT) and intraoperative oxygen index. Secondary endpoints will be serum IL-6, TNF-α, procalcitonin (PCT) kinetics during and after surgery, incidence of PPCs, organ dysfunction, length of in-hospital stay, and hospital expense.
DISCUSSION


Although there are several studies about the effect of iPEEP titration on perioperative PPCs in obese patients recently, the iPEEP setting method they used was complex and was not always feasible in routine clinical practice. This trial will assess a possible simple method to determine individualized optimal PEEP in obese patients and try to demonstrate that individualized PEEP with lung-protective ventilation methods is necessary for obese patients undergoing general surgery. The results of this trial will support anesthesiologist a feasible Cstat-directed PEEP titration method during anesthesia for obese patients in attempt to prevent PPCs.
TRIAL REGISTRATION


www.chictr.org.cn ChiCTR1900026466. Registered on 11 October 2019.",2020,"Secondary endpoints will be serum IL-6, TNF-α, procalcitonin (PCT) kinetics during and after surgery, incidence of PPCs, organ dysfunction, length of in-hospital stay, and hospital expense.
","['obese patients', 'Obese patients undergoing', '80 obese patients with body mass index ≥\u200932.5\u2009kg/m 2  scheduled for laparoscopic gastric volume reduction and at medium to high risk for PPCs will be enrolled', 'obese patients undergoing general surgery']","['individualized PEEP with lung-protective ventilation methods', 'general anesthesia and mechanical ventilation', 'intraoperative individualized PEEP', 'individualized positive end-expiratory pressure (iPEEP', 'pneumoperitoneum and mechanical ventilation', 'iPEEP titration', 'iPEEP']","['low tidal volumes', 'serum IL-6, TNF-α, procalcitonin (PCT) kinetics during and after surgery, incidence of PPCs, organ dysfunction, length of in-hospital stay, and hospital expense', 'postoperative atelectasis measured by chest electrical impedance tomography (EIT) and intraoperative oxygen index', 'postoperative atelectasis']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.149819,"Secondary endpoints will be serum IL-6, TNF-α, procalcitonin (PCT) kinetics during and after surgery, incidence of PPCs, organ dysfunction, length of in-hospital stay, and hospital expense.
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China. anlixin8120@163.com.'}, {'ForeName': 'Ya-Fan', 'Initials': 'YF', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Wen-Jing', 'Initials': 'WJ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}]",Trials,['10.1186/s13063-020-04565-y']
2204,32631422,"Effects of a novel nutraceutical combination (BruMeChol™) in subjects with mild hypercholesterolemia: study protocol of a randomized, double-blind, controlled trial.","BACKGROUND


Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering and inflammation-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. Here, we describe the study protocol of a clinical trial aimed to evaluate the cholesterol and inflammatory lowering effect of an innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits in association with vitamin K2 in subjects with mild hypercholesterolemia.
METHODS


The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age ≥ 40 years) with mild hypercholesterolemia (total serum cholesterol levels ≥ 200 and ≤ 250 mg/dl) will be recruited. Intervention arm participants will take one capsule of dietary supplement two times a day, 15 min before the main meal. Control arm participants will receive one capsule of placebo in the same way. The dietary supplement capsule contains the following ingredients: phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2. Participants will undergo a medical evaluation and chemical-clinical examinations, which include lipid profile, glycemia, biomarkers of renal, liver and cardiac/muscular functions, interleukins (IL 6, IL-32, IL-37, and IL-38), and innovative mediators of inflammation such as inflamma-miRs (miR-21 and miR-146a), at baseline, and after 6 and 12 weeks of treatment. The decrease in total cholesterol levels and inflammatory biomarkers will be the primary and secondary endpoints of the study.
DISCUSSION


This protocol study, planned to verify the effects of BruMeChol™ dietary supplementation in subjects with mild hypercholesterolemia, could also contribute to new study designs for next large-scale multicenter clinical trials.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12619000170123 . Retrospectively registered on 5 February 2019.",2020,"The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy.","['12\u2009weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy', '125 subjects (age ≥\u200940\u2009years) with mild hypercholesterolemia (total serum cholesterol levels ≥\u2009200 and ≤\u2009250\u2009mg/dl) will be recruited', 'subjects with mild hypercholesterolemia']","['BruMeChol™ dietary supplementation', 'innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits', 'novel nutraceutical combination (BruMeChol™', 'phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2', 'placebo']",['total cholesterol levels and inflammatory biomarkers'],"[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445432', 'cui_str': 'Ancona'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1258049', 'cui_str': 'Citrus bergamia'}, {'cui': 'C1122969', 'cui_str': 'Common Olive Tree'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",125.0,0.494046,"The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy.","[{'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Bonfigli', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Protic', 'Affiliation': 'Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy. o.protic@inrca.it.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Olivieri', 'Affiliation': 'Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Montesanto', 'Affiliation': 'Department of Biology, Ecology and Earth Sciences, University of Calabria, Rende, Italy.'}, {'ForeName': 'Gelsomina', 'Initials': 'G', 'LastName': 'Malatesta', 'Affiliation': 'Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Di Pillo', 'Affiliation': 'Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': 'Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.'}]",Trials,['10.1186/s13063-020-04551-4']
2205,32631427,Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial.,"BACKGROUND


Cancer-related fatigue (CRF) is the most taxing symptom for many breast cancer patients during and after therapy. In patients with metastatic disease, the prevalence of CRF exceeds 75%. Currently, there is no gold standard for the treatment of CRF. Physical activity can reduce CRF and is recommended during and after cancer treatment, but may be too burdensome for patients with metastatic breast cancer. The aim of this study is to assess the effect on fatigue of eurythmy therapy (ERYT) compared to slow movement fitness (CoordiFit) in metastatic breast cancer patients.
METHODS


The ERYT/CoordiFit study is a randomized controlled, open-label, two-arm, multi-center Swiss clinical trial. A sample of 196 patients presenting with CRF will be recruited by oncologists from the departments of clinical oncology at each local study site. All participants will be randomly allocated to the intervention or control group in a 1:1 ratio. The control group is an active control intervention (CoordiFit) in order to control for potential non-intended effects such as therapist-patient interaction and participation in a program. Both ERYT and CoordiFit exercises are easy to learn, and the training sessions will follow the same frequency and duration schedule, i.e., 13 standardized therapy sessions of 45 min (once a week for 6 weeks and then once every second week) during the total intervention period of 20 weeks. The primary endpoint of the study is the change from baseline over the whole intervention period (i.e., including measurements at baseline, weeks 8, 14, and 20) in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale score.
DISCUSSION


This study is the first-known randomized clinical trial assessing eurythmy therapy in the treatment of fatigue in metastatic breast cancer patients. Given the distress that fatigue causes patients, it is important to validate treatment options. If eurythmy therapy proves beneficial in CRF as part of this randomized controlled clinical trial, the study may be very impactful with implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists, and funding and regulatory bodies.
TRIAL REGISTRATION


The ERYT/CoordiFit trial was registered at the US National Institutes of Health (ClinicalTrials.gov) on July 18, 2019, #NCT04024267 , and in the portal for human research in Switzerland on December 3, 2019, #SNCTP000003525 .",2020,The control group is an active control intervention (CoordiFit) in order to control for potential non-intended effects such as therapist-patient interaction and participation in a program.,"['patients with metastatic breast cancer', 'metastatic breast cancer patients', 'patients with metastatic disease', '196 patients presenting with CRF will be recruited by oncologists from the departments of clinical oncology at each local study site', 'many breast cancer patients during and after therapy']","['active control intervention (CoordiFit', 'eurythmy therapy', 'Eurythmy therapy versus slow movement fitness', 'eurythmy therapy (ERYT']",['Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C1274034', 'cui_str': 'Clinical oncology'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",196.0,0.0680314,The control group is an active control intervention (CoordiFit) in order to control for potential non-intended effects such as therapist-patient interaction and participation in a program.,"[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Meier-Girard', 'Affiliation': 'Institute of Complementary and Integrative Medicine, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland. delphine.meier@ikim.unibe.ch.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'International Breast Cancer Study Group, Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Gerstenberg', 'Affiliation': 'Institute of Complementary and Integrative Medicine, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Breast Center of Eastern Switzerland, St. Gallen, Switzerland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Wolf', 'Affiliation': 'Institute of Complementary and Integrative Medicine, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland.'}]",Trials,['10.1186/s13063-020-04542-5']
2206,32631447,"Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).","BACKGROUND


Despite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids but little high-quality evidence to guide clinicians. This study aims to define the role of a 1:1 delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD) cannabinoid preparation in the management of symptom burden in patients with advanced cancer undergoing standard palliative care.
METHODS AND DESIGN


One hundred fifty participants will be recruited from five sites within the Queensland Palliative Care Research Group (QPCRG) and randomly assigned to an active treatment or placebo group. This study is a pragmatic multicentre, randomised, placebo-controlled, two-arm trial of escalating doses of an oral 1:1 THC/CBD cannabinoid preparation. It will compare efficacy and safety outcomes of a titrated dose (10 mg/10 mg/mL oral solution formulation, dose range 2.5 mg/2.5 mg-30 mg/30 mg/day) against placebo. There is a 2-week patient-determined titration phase, using escalating doses of 1:1 THC/CBD or placebo, to reach a dose that achieves symptom relief with tolerable side effects. This is then followed by a further 2-week assessment period on the stable dose determined in collaboration with clinicians. The primary objective is to assess the effect of escalating doses of a 1:1 THC/CBD cannabinoid preparation against placebo on change in total symptom score, with secondary objectives including establishing a patient-determined effective dose, the change in total physical and emotional sores, global impression of change, anxiety and depression, opioid use, quality of life and adverse effects.
DISCUSSION


This will be the first placebo-controlled clinical trial to rigorously evaluate the efficacy, safety and acceptability of 1:1 THC/CBD for symptom relief in advanced cancer patients. This study will allow the medical community to have some evidence to present to patients wishing to access cannabis for their symptoms caused by advanced malignancy.
TRIAL REGISTRATION


ACTRN, ACTRN12619000037101 . Registered on 14 January 2019. Trial Sponsor: Mater Misericordiae Limited (MML) and Mater Medical Research Institute Limited (MMRI)-Raymond Terrace, South Brisbane, Brisbane, QLD, Australia.",2020,"This will be the first placebo-controlled clinical trial to rigorously evaluate the efficacy, safety and acceptability of 1:1 THC/CBD for symptom relief in advanced cancer patients.","['One hundred fifty participants will be recruited from five sites within the Queensland Palliative Care Research Group (QPCRG', 'patients with advanced cancer', 'patients with advanced cancer undergoing standard palliative care', 'advanced cancer patients', 'patients with advanced cancer still experience substantial symptom distress']","['oral 1:1 THC/CBD cannabinoid preparation', 'delta-9-tetrahydrocannabinol', 'THC/CBD', 'THC/CBD or placebo', 'Oral medicinal cannabinoids', 'THC/CBD cannabinoid preparation against placebo', 'delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD) cannabinoid preparation', 'placebo']","['total physical and emotional sores, global impression of change, anxiety and depression, opioid use, quality of life and adverse effects', 'efficacy, safety and acceptability', 'THC) and cannabidiol (CBD', 'total symptom score']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.498463,"This will be the first placebo-controlled clinical trial to rigorously evaluate the efficacy, safety and acceptability of 1:1 THC/CBD for symptom relief in advanced cancer patients.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Mater Health Services, Mater Research Institute-University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Haywood', 'Affiliation': 'School of Pharmacy, Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Gogna', 'Affiliation': 'Greenslopes Private Hospital, Brisbane, Gold Coast Health Service, Gold Coast, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'The Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Newcastle, Australia.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Ristan', 'Initials': 'R', 'LastName': 'Greer', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Good', 'Affiliation': ""Mater Health Services, Mater Research Institute-University of Queensland, St Vincent's Private Hospital, Brisbane, Australia. Phillip.Good@mater.org.au.""}]",Trials,['10.1186/s13063-020-04541-6']
2207,32640132,Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus.,"BACKGROUND


Nemolizumab is a subcutaneously administered humanized monoclonal antibody against interleukin-31 receptor A, which is involved in pruritus and inflammation in atopic dermatitis. In phase 2 studies, nemolizumab lessened the severity of atopic dermatitis.
METHODS


In a 16-week, double-blind, phase 3 trial, we randomly assigned Japanese patients with atopic dermatitis and moderate-to-severe pruritus and an inadequate response to topical agents in a 2:1 ratio to receive subcutaneous nemolizumab (60 mg) or placebo every 4 weeks until week 16, with concomitant topical agents. The primary end point was the mean percent change in the visual-analogue scale (VAS) score for pruritus (range, 0 to 100, with higher scores indicating worse pruritus) from baseline to week 16. Secondary end points included the time course of change in the VAS score for pruritus up to week 4, the change in the Eczema Area and Severity Index (EASI) score (range, 0 to 72, with higher scores indicating greater severity), a score of 4 or less on the Dermatology Life Quality Index (DLQI; range, 0 to 30, with higher scores indicating a greater effect on daily life), a score of 7 or less on the Insomnia Severity Index (ISI; range, 0 to 28, with higher scores indicating greater severity), and safety.
RESULTS


A total of 143 patients were randomly assigned to receive nemolizumab and 72 to receive placebo. The median VAS score for pruritus at baseline was 75. At week 16, the mean percent change in the VAS score was -42.8% in the nemolizumab group and -21.4% in the placebo group (difference, -21.5 percentage points; 95% confidence interval, -30.2 to -12.7; P<0.001). The mean percent change in the EASI score was -45.9% with nemolizumab and -33.2% with placebo. The percentage of patients with a DLQI score of 4 or less was 40% in the nemolizumab group and 22% in the placebo group; the percentage of patients with an ISI score of 7 or less was 55% and 21%, respectively. The incidence of injection-related reactions was 8% with nemolizumab and 3% with placebo.
CONCLUSIONS


In this 16-week trial, the use of subcutaneous nemolizumab in addition to topical agents for atopic dermatitis resulted in a greater reduction in pruritus than placebo plus topical agents. The incidence of injection-site reactions was greater with nemolizumab than with placebo. Longer and larger trials are necessary to determine whether nemolizumab has a durable effect and is safe for atopic dermatitis. (Funded by Maruho; JapicCTI number, 173740.).",2020,"At week 16, the mean percent change in the VAS score was -42.8% in the nemolizumab group and -21.4% in the placebo group (difference, -21.5 percentage points; 95% confidence interval, -30.2 to -12.7; P<0.001).","['A total of 143 patients', 'Atopic Dermatitis with Pruritus', 'Japanese patients with atopic dermatitis and moderate-to-severe pruritus and an inadequate response to topical agents in a 2:1 ratio to receive']","['Nemolizumab and Topical Agents', 'nemolizumab', 'placebo', 'subcutaneous nemolizumab']","['VAS score', 'daily life', 'DLQI score', 'ISI score', 'Eczema Area and Severity Index (EASI) score', 'mean percent change in the visual-analogue scale (VAS) score for pruritus', 'Insomnia Severity Index', 'severity of atopic dermatitis', 'time course of change in the VAS score for pruritus', 'severity), and safety', 'incidence of injection-related reactions', 'median VAS score for pruritus', 'incidence of injection-site reactions', 'Dermatology Life Quality Index (DLQI; range', 'EASI score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",143.0,0.410175,"At week 16, the mean percent change in the VAS score was -42.8% in the nemolizumab group and -21.4% in the placebo group (difference, -21.5 percentage points; 95% confidence interval, -30.2 to -12.7; P<0.001).","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': ""From the Department of Dermatology, Graduate School of Medicine, Kyoto University (K.K.), and the Departments of Clinical Development (T.M.) and Data Science (H.K.), Maruho, Kyoto, and Tokyo Women's Medical University, Tokyo (M.K.) - all in Japan.""}, {'ForeName': 'Takayo', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': ""From the Department of Dermatology, Graduate School of Medicine, Kyoto University (K.K.), and the Departments of Clinical Development (T.M.) and Data Science (H.K.), Maruho, Kyoto, and Tokyo Women's Medical University, Tokyo (M.K.) - all in Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Komazaki', 'Affiliation': ""From the Department of Dermatology, Graduate School of Medicine, Kyoto University (K.K.), and the Departments of Clinical Development (T.M.) and Data Science (H.K.), Maruho, Kyoto, and Tokyo Women's Medical University, Tokyo (M.K.) - all in Japan.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""From the Department of Dermatology, Graduate School of Medicine, Kyoto University (K.K.), and the Departments of Clinical Development (T.M.) and Data Science (H.K.), Maruho, Kyoto, and Tokyo Women's Medical University, Tokyo (M.K.) - all in Japan.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1917006']
2208,32371537,"NSABP B-41, a Randomized Neoadjuvant Trial: Genes and Signatures Associated with Pathologic Complete Response.","PURPOSE


In NSABP B-41, pathologic complete response (pCR) was associated with prolonged survival among women with HER2-positive operable breast cancer treated with neoadjuvant chemotherapy and lapatinib, trastuzumab, or the combination. We used a large human breast cancer gene expression panel to select candidate prognostic biomarkers for pCR among women treated with trastuzumab in NSABP B-41.
PATIENTS AND METHODS


Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent. We analyzed extracted RNA using the human nCounter Breast Cancer 360 gene expression panel. Gene counts were normalized to housekeeping genes and transformed into logarithmic scale with base 2. To screen for candidate genes and metagene signatures prognostic of pCR, we used univariate logistic regression. Variable selection was done by multivariable logistic regression with lasso regularization.
RESULTS


Analyses of data from 130 patients revealed that a composite of gene expression from 19 genes and one gene signature appeared to predict pCR in women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens. The identified genes are involved in important pathways such as epithelial-mesenchymal transition, adhesion and migration, estrogen receptor signaling, DNA damage and repair, apoptosis, and proliferation. The AUC from a 10-fold cross-validation on predicting pCR, with these 20 genomic markers in a logistic regression model, was 0.73.
CONCLUSIONS


The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens. These findings need to be validated and calibrated in future studies.",2020,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","['130 patients', 'women with HER2-positive operable breast cancer treated with', 'Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent', 'human nCounter Breast Cancer 360 gene expression panel', 'women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens']","['trastuzumab', 'neoadjuvant chemotherapy and lapatinib, trastuzumab']",[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]",[],,0.0832425,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC. sms248@georgetown.edu.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Heather Ann', 'Initials': 'HA', 'LastName': 'Brauer', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goerlitz', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brent T', 'Initials': 'BT', 'LastName': 'Harris', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bandos', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0152']
2209,31582354,"Time-to-progression after front-line fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy for chronic lymphocytic leukaemia: a retrospective, multicohort study.","BACKGROUND


Fludarabine, cyclophosphamide, and rituximab (FCR) has become a gold-standard chemoimmunotherapy regimen for patients with chronic lymphocytic leukaemia. However, the question remains of how to treat treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia. We therefore aimed to develop and validate a gene expression signature to identify which of these patients are likely to achieve durable remissions with FCR chemoimmunotherapy.
METHODS


We did a retrospective cohort study in two cohorts of treatment-naive patients (aged ≥18 years) with chronic lymphocytic leukaemia. The discovery and training cohort consisted of peripheral blood samples collected from patients treated at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), who fulfilled the diagnostic criteria of the International Workshop on Chronic Lymphocytic Leukemia, had received at least three cycles of FCR chemoimmunotherapy, and had been treated between Oct 10, 2000, and Oct 26, 2006 (ie, the MDACC cohort). We did transcriptional profiling on samples obtained from the MDACC cohort to identify genes associated with time to progression. We did univariate Cox proportional hazards analyses and used significant genes to cluster IGHV-unmutated samples into two groups (intermediate prognosis and unfavourable prognosis). After using cross-validation to assess robustness, we applied the Lasso method to standardise the gene expression values to find a minimum gene signature. We validated this signature in an external cohort of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia enrolled on the CLL8 trial of the German Chronic Lymphocytic Leukaemia Study Group who were treated between July 21, 2003, and April 4, 2006 (ie, the CLL8 cohort).
FINDINGS


The MDACC cohort consisted of 101 patients and the CLL8 cohort consisted of 109 patients. Using the MDACC cohort, we identified and developed a 17-gene expression signature that distinguished IGHV-unmutated patients who were likely to achieve a long-term remission following front-line FCR chemoimmunotherapy from those who might benefit from alternative front-line regimens (hazard ratio 3·83, 95% CI 1·94-7·59; p<0·0001). We validated this gene signature in the CLL8 cohort; patients with an unfavourable prognosis versus those with an intermediate prognosis had a cause-specific hazard ratio of 1·90 (95% CI 1·18-3·06; p=0·008). Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
INTERPRETATION


We have developed a robust, reproducible 17-gene signature that identifies a subset of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia who might substantially benefit from treatment with FCR chemoimmunotherapy. We recommend testing the value of this gene signature in a prospective study that compares FCR treatment with newer alternative therapies as part of a randomised clinical trial.
FUNDING


Chronic Lymphocytic Leukaemia Global Research Foundation and the National Institutes of Health/National Cancer Institute.",2019,"Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
","['patients treated at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), who fulfilled the diagnostic criteria of the International Workshop on Chronic Lymphocytic Leukemia, had received at least three cycles of FCR chemoimmunotherapy, and had been treated between Oct 10, 2000, and Oct 26, 2006 (ie, the MDACC cohort', 'patients with chronic lymphocytic leukaemia', 'chronic lymphocytic leukaemia', 'two cohorts of treatment-naive patients (aged ≥18 years) with chronic lymphocytic leukaemia', 'naive patients with IGHV-unmutated chronic lymphocytic leukaemia', 'external cohort of treatment-naive patients with IGHV-unmutated chronic lymphocytic leukaemia enrolled on the CLL8 trial of the German Chronic Lymphocytic Leukaemia Study Group who were treated between July 21, 2003, and April 4, 2006 (ie, the CLL8 cohort', '101 patients and the CLL8 cohort consisted of 109 patients']","['Fludarabine, cyclophosphamide, and rituximab (FCR', 'fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy', 'FCR chemoimmunotherapy']",['Median time to progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",101.0,0.0518222,"Median time to progression was 39 months (IQR 22-69) for those with an unfavourable prognosis compared with 59 months (28-84) for those with an intermediate prognosis.
","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Coombes', 'Affiliation': 'Department of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Lynn L', 'Initials': 'LL', 'LastName': 'Barron', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zachary B', 'Initials': 'ZB', 'LastName': 'Abrams', 'Affiliation': 'Department of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Majewski', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jolanta E', 'Initials': 'JE', 'LastName': 'Bondaruk', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, Aachen-Bonn-Cologne-Duesseldorf, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Bogdan A', 'Initials': 'BA', 'LastName': 'Czerniak', 'Affiliation': 'Department of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Oakes', 'Affiliation': 'Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Keating', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne V', 'Initials': 'LV', 'LastName': 'Abruzzo', 'Affiliation': 'Department of Pathology, The Ohio State University, Columbus, OH, USA. Electronic address: lynne.abruzzo@osumc.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30503-0']
2210,30580464,Exploring the emotional and behavioural reactions to receiving personalized melanoma genomic risk information: a qualitative study.,"BACKGROUND


There is a need for greater understanding of the spectrum of emotional and behavioural reactions that individuals in the general population may experience in response to genomic testing for melanoma risk.
OBJECTIVES


To explore how individuals in the general population respond to receiving personalized genomic risk of melanoma.
METHODS


Semistructured interviews were undertaken with 30 participants (aged 24-69 years, 50% female, 12 low risk, eight average risk, 10 high risk) recruited from a pilot trial in which they received personalized melanoma genomic risk information. We explored participants' emotional and behavioural responses to receiving their melanoma genomic risk information. The qualitative data were analysed thematically.
RESULTS


Many participants reported a positive response to receiving their melanoma genomic risk, including feelings of happiness, reassurance and gaining new knowledge to help manage their melanoma risk. Some participants reported short-term negative emotional reactions that dissipated over time. Most individuals, particularly those who received average or high-risk results, reported making positive behaviour changes to reduce their melanoma risk. Emotional and behavioural responses were linked to participants' expectations for their risk result, their pre-existing perception of their own melanoma risk, their existing melanoma preventive behaviours and their genomic risk category.
CONCLUSIONS


Personalized melanoma genomic risk information alongside education and lifestyle counselling is favourably received by people without a personal history and unselected for a family history of melanoma. Participants described increased knowledge and awareness around managing skin cancer risk and improved sun protection and skin examination behaviours. Any initial feelings of distress usually dissipated over time.",2019,"Most individuals, particularly those who received average or high-risk results, reported making positive behaviour changes to reduce their melanoma risk.","['Semistructured interviews were undertaken with 30 participants (aged 24-69 years, 50% female, 12 low risk, eight average risk, 10 high risk) recruited from a pilot trial in which they received personalized melanoma genomic risk information']",[],"['Emotional and behavioural responses', 'short-term negative emotional reactions', 'knowledge and awareness around managing skin cancer risk and improved sun protection and skin examination behaviours']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0436149', 'cui_str': 'Examination of skin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.135046,"Most individuals, particularly those who received average or high-risk results, reported making positive behaviour changes to reduce their melanoma risk.","[{'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Fenton', 'Affiliation': 'Cancer Epidemiology and Prevention Research, The University of Sydney, NSW, Australia.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Smit', 'Affiliation': 'Cancer Epidemiology and Prevention Research, The University of Sydney, NSW, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Keogh', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Vic., Australia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Cust', 'Affiliation': 'Cancer Epidemiology and Prevention Research, The University of Sydney, NSW, Australia.'}]",The British journal of dermatology,['10.1111/bjd.17582']
2211,30635862,Factors affecting linkage to HIV care and ART initiation following referral for ART by a mobile health clinic in South Africa: evidence from a multimethod study.,"Linkage to care from mobile clinics is often poor and inadequately understood. This multimethod study assessed linkage to care and antiretroviral therapy (ART) uptake following ART-referral by a mobile clinic in Cape Town (2015/2016). Clinic record data (N = 86) indicated that 67% linked to care (i.e., attended a clinic) and 42% initiated ART within 3 months. Linkage to care was positively associated with HIV-status disclosure intentions (aOR: 2.99, 95% CI 1.13-7.91), and treatment readiness (aOR: 2.97, 95% CI 1.05-8.34); and negatively with good health (aOR: 0.35, 95% CI 0.13-0.99), weekly alcohol consumption (aOR: 0.35, 95% CI 0.12-0.98), and internalised stigma (aOR: 0.32, 95% CI 0.11-0.91). Following linkage, perceived stigma negatively affected ART-initiation. In-depth interviews (N = 41) elucidated fears about ART side-effects, HIV-status denial, and food insecurity as barriers to ART initiation; while awareness of positive ART-effects, follow-up telephone counselling, familial responsibilities, and maintaining health to avoid involuntary disclosure were motivating factors. Results indicate that an array of interventions are required to encourage rapid ART-initiation following mobile clinic HIV-testing services.",2019,"Linkage to care was positively associated with HIV-status disclosure intentions (aOR: 2.99, 95% CI 1.13-7.91), and treatment readiness (aOR: 2.97, 95% CI 1.05-8.34); and negatively with good health (aOR: 0.35, 95% CI 0.13-0.99), weekly alcohol consumption (aOR: 0.35, 95% CI 0.12-0.98), and internalised stigma (aOR: 0.32, 95% CI 0.11-0.91).",[],[],"['HIV-status disclosure intentions', 'weekly alcohol consumption', 'internalised stigma']",[],[],"[{'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.195792,"Linkage to care was positively associated with HIV-status disclosure intentions (aOR: 2.99, 95% CI 1.13-7.91), and treatment readiness (aOR: 2.97, 95% CI 1.05-8.34); and negatively with good health (aOR: 0.35, 95% CI 0.13-0.99), weekly alcohol consumption (aOR: 0.35, 95% CI 0.12-0.98), and internalised stigma (aOR: 0.32, 95% CI 0.11-0.91).","[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Maughan-Brown', 'Affiliation': 'Southern Africa Labour and Development Research Unit (SALDRU), University of Cape Town, Private Bag, Rondebosch, Cape Town, 7701, South Africa. brendan.maughanbrown@gmail.com.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Galárraga', 'Affiliation': 'Department of Health Services, Policy and Practice (HSPP), Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kuo', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Lurie', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-0005-x']
2212,30799237,"Comparison of Sebia Free Light Chain Assay With Freelite Assay for the Clinical Management of Diagnosis, Response, and Relapse Assessment in Multiple Myeloma.","BACKGROUND


Serum free light chain (FLC) measurement has become an important marker for the management of multiple myeloma (MM). However, several analytical challenges remain unresolved. We compared the clinical performances of the Sebia FLC assay in MM to the Freelite assay.
PATIENTS AND METHODS


A total of 177 patients from the IFM DFCI 2009 trial were enrolled onto this study, with a total of 368 samples analyzed. At baseline, concordance of the involved to noninvolved FLC ratio (iFLC/niFLC) was evaluated. During therapy, comparison of the disease response assessments according to International Myeloma Working Group criteria was performed.
RESULTS


Compared to Freelite, the Sebia FLC assay demonstrated lower results, with a proportional bias with increased values. We demonstrated that the Sebia equivalent of the iFLC/niFLC ratio of 100 was 16. During follow-up, agreement in response assessment was moderate (for light chains MM) to good (for intact immunoglobulin MM). In the context of relapse, the concordance was moderate, but longitudinal follow-up showed a similar kinetics.
CONCLUSION


The Sebia FLC assay provides inequivalent absolute results from the Freelite assay. Despite lower absolute FLC values, the kinetics of response and relapse is exactly the same. As with other FLC assays available, follow-up of MM with the same method is advisable.",2019,"Compared to Freelite, the Sebia FLC assay demonstrated lower results, with a proportional bias with increased values.","['177 patients from the IFM DFCI 2009 trial were enrolled onto this study, with a total of 368 samples analyzed']","['Serum free light chain (FLC) measurement', 'Sebia Free Light Chain Assay With Freelite Assay']",['noninvolved FLC ratio (iFLC/niFLC'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",177.0,0.0161835,"Compared to Freelite, the Sebia FLC assay demonstrated lower results, with a proportional bias with increased values.","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Caillon', 'Affiliation': 'Department of Biochemistry, University Hospital of Nantes, Nantes, France. Electronic address: helene.caillon@chu-nantes.fr.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unity of Genomics in Myeloma, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Department of Hematology, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Decaux', 'Affiliation': 'Department of Internal Medicine, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dejoie', 'Affiliation': 'Department of Biochemistry, University Hospital of Nantes, Nantes, France.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2019.01.007']
2213,31109262,Self-Determination and Choice in Mental Health: Qualitative Insights From a Study of Self-Directed Care.,SELF-DETERMINATION AND CHOICE IN MENTAL HEALTH.,2019,SELF-DETERMINATION AND CHOICE IN MENTAL HEALTH.,[],[],[],[],[],[],,0.0203453,SELF-DETERMINATION AND CHOICE IN MENTAL HEALTH.,"[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Thomas', 'Affiliation': 'College of Public Health, Temple University, Philadelphia.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Zisman-Ilani', 'Affiliation': 'College of Public Health, Temple University, Philadelphia.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Salzer', 'Affiliation': 'College of Public Health, Temple University, Philadelphia.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800544']
2214,31260843,ACL reconstruction with lateral plasty reduces translational and rotatory laxity compared to anatomical single bundle and non-anatomical double bundle surgery: An in vivo kinematic evaluation with navigation system.,"BACKGROUND


Significantly better stability may be achieved with a Single Bundle Lateral Plasty (SBLP) reconstruction compared with the Single Bundle (SB) and Double Bundle (DB) procedures.
METHODS


The study included 42 patients who underwent ACL reconstruction. Patients were randomly selected for one of the following surgical procedure defining three study groups: Single-Bundle-Lateral-Plasty, Single-Bundle and Double-Bundle procedures. Laxity evaluation was performed with an intraoperative navigation system. Lachman test (AP30), Drawer test (AP90), Varus-Valgus stress test at 0° and 30° knee flexion (VV0, VV30), Internal-External rotation (IE30, IE90), and pivot shift (PS) test are the clinical test executed for the laxity evaluation. Laxity reduction was defined as the difference between laxity before the fixation of the graft used for the reconstruction and the laxity just after its fixation.
FINDINGS


For all the analyzed surgical techniques, the pre-reconstruction laxity values were statistically higher (P < 0.05) than the post-reconstruction values for all the analyzed tests. The analysis of the Drawer test and Internal-External rotation at 30° and 90° of knee flexion, highlighted a significant difference at time zero after surgery among the three study groups. The results showed that the SBLP technique had the highest reduction values compared to SB (P IE90  = 0.001) and DB (P AP90  = 0.012; P IE30  = 0.021; P IE90  = 0.003) techniques.
INTERPRETATION


SBLP technique showed significantly superior results in terms of antero-posterior and internal-external laxity reduction at time-zero after ACL reconstruction.",2019,"For all the analyzed surgical techniques, the pre-reconstruction laxity values were statistically higher (P < 0.05) than the post-reconstruction values for all the analyzed tests.",['42 patients who underwent ACL reconstruction'],"['Single Bundle Lateral Plasty (SBLP) reconstruction compared with the Single Bundle (SB) and Double Bundle (DB) procedures', 'Single-Bundle-Lateral-Plasty, Single-Bundle and Double-Bundle procedures', 'ACL reconstruction with lateral plasty', 'anatomical single bundle and non-anatomical double bundle surgery']","['pre-reconstruction laxity values', 'Lachman test (AP30), Drawer test (AP90), Varus-Valgus stress test at 0° and 30° knee flexion (VV0, VV30), Internal-External rotation (IE30, IE90), and pivot shift (PS) test', 'translational and rotatory laxity', 'Laxity reduction', 'antero-posterior and internal-external laxity reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231752', 'cui_str': 'Lachman test response'}, {'cui': 'C0231735', 'cui_str': 'Drawer test'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0231733', 'cui_str': 'Abduction test'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205101', 'cui_str': 'External'}]",42.0,0.017857,"For all the analyzed surgical techniques, the pre-reconstruction laxity values were statistically higher (P < 0.05) than the post-reconstruction values for all the analyzed tests.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Grassi', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy. Electronic address: alberto.grassi@ior.it.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Signorelli', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy. Electronic address: c.signorelli@biomec.ior.it.'}, {'ForeName': 'Gian Andrea', 'Initials': 'GA', 'LastName': 'Lucidi', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy. Electronic address: gianandrea.lucidi@studio.unibo.it.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Raggi', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Macchiarola', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Roberti Di Sarsina', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Marcheggiani Muccioli', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di NanoBiotecnologie (NaBi), Via Di Barbiano 1/10, 40136 Bologna, BO, Italy. Electronic address: ortho@gfilardo.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Laboratorio di Biomeccanica e Innovazione Tecnologica, Via Di Barbiano 1/10, 40136 Bologna, BO, Italy; IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica I, Via Pupilli 1, 40136 Bologna, BO, Italy; Università di Bologna, Dipartimento di Scienze Biomediche e NeuroMotorie (DIBINEM), Via Foscolo 7, 40123 Bologna, BO, Italy. Electronic address: stefano.zaffagnini@unibo.it.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.06.012']
2215,31611499,"Stable Hemodynamics within ""No-Touch"" Saphenous Vein Graft.","PURPOSE


To investigate the hemodynamics characteristics of the ""no-touch"" saphenous vein graft (SVG) conduits by nicardipine intraluminal administration in vivo experiment.
METHODS


A total of 59 consecutive patients were enrolled and underwent a sequential SVG to three non-left anterior descending (LAD) targets with the average runoff ≤2 mm, 30 with ""no-touch"" harvest technique (group A) and 29 with conventional preparation (group B). The patients were subject to nicardipine intraluminal injection during off-pump coronary artery bypass grafting (CABG) procedure. The intraoperative flow was measured with the ultrasonic transit time flow meter (TTFM), and the graft patency testified by multi-detector computed tomography (MDCT) angiography, respectively.
RESULTS


The baseline blood flow was higher in group A than that in group B (p <0.05). However, the increases in blood flow of SVG conduits in group A were lower than those in group B with 19.7 ± 5.9 vs. 35.4 ± 9.2 mL/min, 14.8 ± 5.6 vs. 23.1 ± 6.8 mL/min, 6.6 ± 2.1 vs. 11.2 ± 4.3 mL/min before the first, second, and third anastomose after nicardipine intraluminal administration, respectively (all p <0.01).
CONCLUSIONS


No-touch SVGs were associated with higher baseline blood flow and less rises after nicardipine intraluminal administration during off-pump CABG procedure compared with conventional preparation. The no-touch SVGs seemed to be less spastic and well-tolerated on flow dilatation.",2020,The baseline blood flow was higher in group A than that in group B (p <0.05).,"['59 consecutive patients were enrolled and underwent a sequential SVG to three non-left anterior descending (LAD) targets with the average runoff ≤2 mm, 30 with']","['no-touch"" saphenous vein graft (SVG) conduits by nicardipine intraluminal', 'nicardipine intraluminal injection during off-pump coronary artery bypass grafting (CABG) procedure', 'no-touch"" harvest technique (group A) and 29 with conventional preparation', 'nicardipine']","['intraoperative flow', 'blood flow of SVG conduits', 'baseline blood flow', 'ultrasonic transit time flow meter (TTFM), and the graft patency testified']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}]","[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016266', 'cui_str': 'Flowmeter'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",59.0,0.0191366,The baseline blood flow was higher in group A than that in group B (p <0.05).,"[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiac Surgery, Sichuan Provincial People's Hospital; Affiliated Hospital of University of Electronic Science and Technology, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hansong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lv', 'Affiliation': 'Department of Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shengshou', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.19-00156']
2216,32639241,THE 11TH TRIAL OF A CARDIOVASCULAR CLINICAL TRIALIST CORONAVIRUS-2: PART 2.,,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Dept. of Medicine New York Medical College/Westchester Medical Center 40 Sunshine Cottage Road Valhalla, NY 10595 William.Frishman@wmchealth.org; William_Frishman@nymc.edu.'}]",Cardiology in review,['10.1097/CRD.0000000000000328']
2217,32639254,"Dorsomedial Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation for Tinnitus: Promising Results of a Blinded, Randomized, Sham-Controlled Study.","OBJECTIVES


Tinnitus is the perception of sound in ears or head without corresponding external stimulus. Despite the great amount of literature concerning tinnitus treatment, there are still no evidence-based established treatments for curing or for effectively reducing tinnitus intensity. Sham-controlled studies revealed beneficial effects using repetitive transcranial magnetic stimulation (rTMS). Still, results show moderate, temporary improvement and high individual variability. Subcallosal area (ventral and dorsomedial prefrontal and anterior cingulate cortices) has been implicated in tinnitus pathophysiology. Our objective is to evaluate the use of bilateral, high frequency, dorsomedial prefrontal cortex (DMPFC) rTMS in treatment of chronic subjective tinnitus.
DESIGN


Randomized placebo-controlled, single-blinded clinical trial. Twenty sessions of bilateral, 10 Hz rTMS at 120% of resting motor threshold of extensor hallucis longus were applied over the DMPFC. Fourteen patients underwent sham rTMS and 15 were submitted to active stimulation. Tinnitus Handicap Inventory (THI), visual analog scale, and tinnitus loudness matching were obtained at baseline and on follow-up visits. The impact of intervention on outcome measures was evaluated using mixed-effects restricted maximum likelihood regression model for longitudinal data.
RESULTS


A difference of 11.53 points in the THI score was found, favoring the intervention group (p = 0.05). The difference for tinnitus loudness matching was of 4.46 dB also favoring the intervention group (p = 0.09).
CONCLUSIONS


Tinnitus treatment with high frequency, bilateral, DMPFC rTMS was effective in reducing tinnitus severity measured by THI and matched tinnitus loudness when compared to sham stimulation.",2020,"A difference of 11.53 points in the THI score was found, favoring the intervention group (p = 0.05).","['Fourteen patients underwent', 'Tinnitus']","['repetitive transcranial magnetic stimulation (rTMS', 'sham rTMS', 'placebo']","['THI score', 'Subcallosal area (ventral and dorsomedial prefrontal and anterior cingulate cortices', 'Tinnitus Handicap Inventory (THI), visual analog scale, and tinnitus loudness matching', 'tinnitus loudness matching', 'tinnitus severity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0228282', 'cui_str': 'Parolfactory area structure'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",14.0,0.156326,"A difference of 11.53 points in the THI score was found, favoring the intervention group (p = 0.05).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ciminelli', 'Affiliation': 'Laboratory of Panic and Respiration (LABPR), Institute of Psychiatry (IPUB), Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': 'Physical Activity Neuroscience, Physical Activity Sciences Postgraduate Program, Salgado de Oliveira University, Niterói, Brazil.'}, {'ForeName': 'Manoela', 'Initials': 'M', 'LastName': 'Palmeira', 'Affiliation': 'Laboratory of Panic and Respiration (LABPR), Institute of Psychiatry (IPUB), Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Evandro Silva Freire', 'Initials': 'ESF', 'LastName': 'Coutinho', 'Affiliation': 'National School of Public Health - Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sender', 'Affiliation': 'Juiz de Fora Federal University (UFJF), Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Antonio Egidio', 'Initials': 'AE', 'LastName': 'Nardi', 'Affiliation': 'Laboratory of Panic and Respiration (LABPR), Institute of Psychiatry (IPUB), Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.'}]",Ear and hearing,['10.1097/AUD.0000000000000908']
2218,32639280,Predictive and prognostic value of magnesium serum level in FOLFIRI plus cetuximab or bevacizumab treated patients with stage IV colorectal cancer: results from the FIRE-3 (AIO KRK-0306) study.,"Magnesium wasting is a frequent side effect of epidermal growth factor receptor (EGFR)-antibody treatment as magnesium-absorption mechanisms are dependent on EGFR signaling. EGFR-inhibition results in decreased renal reabsorption. There is evidence that hypomagnesemia during cetuximab treatment correlates with response. The prognostic role of hypomagnesemia during bevacizumab treatment has not been studied yet. Here, we evaluate the prognostic value of hypomagnesemia in patients with metastatic colorectal cancer treated with FOLFIRI plus cetuximab or bevacizumab as first-line therapy. A total of 391 of 752 patients of the firstline irinotecan study population had magnesium levels measured at baseline and for the first three cycles (6 weeks) of treatment. Of those, 240 had Rat Sarkoma wildtype tumors. Overall hypomagnesemia was more common in the cetuximab compared to the bevacizumab arm (80 vs. 43%, P < 0.005). During therapy, magnesium showed a time-dependent decrease to 80% of baseline in the cetuximab and to 89% in the bevacizumab arm. Whereas magnesium continued to decrease over time in the cetuximab-treated patients, it remained stable in the bevacizumab-treated. Overall response rate (ORR) was associated with higher magnesium at week 6 (20.9 vs. 79.1%, P = 0.041). Bevacizumab-treated patients with magnesium levels below the median value at week 6 had a significantly longer progression-free survival (PFS; 11.7 vs. 9.9 months, P = 0.034; hazard ratio 0.73) and a trend towards longer overall survival (OS) (29.6 vs. 23.2 months, P = 0.089; hazard ratio 0.77). Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm. Our data show different magnesium kinetics in patients with metastatic colorectal cancer treated with cetuximab or bevacizumab. For patients treated with cetuximab, hypomagnesemia did not have an impact on response and survival. Hypomagnesemia might have a prognostic value in bevacizumab treatment.",2020,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","['treated patients with stage IV colorectal cancer', 'A total of 391 of 752 patients of the firstline irinotecan study population had', 'patients with metastatic colorectal cancer treated with', '240 had Rat Sarkoma wildtype tumors']","['FOLFIRI plus cetuximab or bevacizumab', 'cetuximab or bevacizumab', 'bevacizumab', 'Bevacizumab']","['ORR, OS and PFS', 'Overall response rate (ORR', 'renal reabsorption', 'progression-free survival', 'overall survival (OS', 'hypomagnesemia', 'Hypomagnesemia', 'Overall hypomagnesemia', 'prognostic value of hypomagnesemia', 'response and survival', 'magnesium levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2610986', 'cui_str': 'Renal Absorption'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]",,0.154894,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Fraccaroli', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Hematology and Oncology, Gesundheitszentrum St. Marien, Amberg.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Medicine II, University Hospital, Johannes Gutenberg University Clinic Mainz, Mainz, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000965']
2219,32639293,A Preliminary Examination of Endogenous Peripheral Oxytocin in a Pilot Randomized Clinical Trial of Oxytocin-Enhanced Psychotherapy for Posttraumatic Stress Disorder.,"BACKGROUND


Preclinical and clinical research suggests that the oxytocin system is implicated in the development and maintenance of stress and anxiety-related psychiatric conditions, such as posttraumatic stress disorder (PTSD). Recent research also suggests that intranasal oxytocin holds promise as a treatment for PTSD. However, little is known about the relationship between levels of peripheral oxytocin and PTSD symptom severity, PTSD treatment response, and repeated intranasal oxytocin administration.
METHODS


In the current study, we examined associations between PTSD symptom severity and peripheral oxytocin levels measured in plasma before and after a course of prolonged exposure (PE) for PTSD (n = 13); participants were randomized to adjunctive intranasal oxytocin (n = 6) or placebo (n = 7).
RESULTS


Baseline peripheral oxytocin levels were not associated with baseline PTSD symptom severity. Change in peripheral oxytocin levels did not differ by treatment condition and did not correspond to change in PTSD symptoms.
CONCLUSIONS


This proof-of-concept study illustrates the acceptability and feasibility of measuring peripheral oxytocin among individuals engaged in psychotherapy for PTSD and informs the utilization of these procedures in future adequately powered studies.",2020,"Change in peripheral oxytocin levels did not differ by treatment condition and did not correspond to change in PTSD symptoms.
","['individuals engaged in psychotherapy for PTSD', 'Posttraumatic Stress Disorder']","['intranasal oxytocin', 'peripheral oxytocin', 'Oxytocin-Enhanced Psychotherapy', 'adjunctive intranasal oxytocin', 'placebo']","['peripheral oxytocin levels', 'Baseline peripheral oxytocin levels', 'PTSD symptom severity and peripheral oxytocin levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",13.0,0.05127,"Change in peripheral oxytocin levels did not differ by treatment condition and did not correspond to change in PTSD symptoms.
","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Sippel', 'Affiliation': 'From the National Center for PTSD, White River Junction, VT.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'King', 'Affiliation': 'Department of Neuroscience.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'MUSC Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001226']
2220,32639369,Individuals with chronic pain have the same response to placebo analgesia as healthy controls in terms of magnitude and reproducibility.,"It is unclear whether a diagnosis of chronic pain is associated with an increase or decrease in the placebo response. The aim of this study was to use an experimental placebo conditioning paradigm to test if expectancy for pain relief impacts on acute pain perception in individuals with a chronic pain diagnosis of osteoarthritis (OA) or fibromyalgia (FM), compared to healthy individuals (HI). An inert cream was applied to the dominant forearm of participants (60 OA, 79 FM and 98 HI), randomly assigned to either a placebo or control group. In both groups an inactive cream was applied to the dominant forearm. The placebo group was told this may or may not be a local anaesthetic cream, while the control group was told the cream was inactive. Laser pain was delivered, and numerical pain intensity ratings collected before, during and after cream application, along with expectation of pain relief and anxiety. The procedure was repeated two weeks later to assess reproducibility. There was a significant reduction in pain in the placebo group, independent of clinical diagnosis. Diagnostic groups (OA,FM,HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief. The results were similar in the repeat session. The results demonstrate that individuals with chronic pain respond to experimental placebo analgesia in a similar and reproducible manner as healthy individuals, despite higher levels of psychological co-morbidity. This has implications for utilising placebo analgesia in the treatment of chronic pain.",2020,"Diagnostic groups (OA,FM,HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief.","['Individuals with chronic pain', 'individuals with chronic pain', 'individuals with a chronic pain diagnosis of osteoarthritis (OA) or fibromyalgia (FM), compared to healthy individuals (HI', 'chronic pain']","['placebo or control group', 'placebo analgesia', 'placebo']","['pain relief and anxiety', 'pain relief', 'Laser pain', 'psychological co-morbidity', 'acute pain perception', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.257629,"Diagnostic groups (OA,FM,HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Power', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Christopher Andrew', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sivan', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lenton', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rainey', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'El-Deredy', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Anthony Kenneth', 'Initials': 'AK', 'LastName': 'Peter Jones', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001966']
2221,32639383,Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial.,"BACKGROUND


Intraoperative monitoring with pupillometry has shown promising results for nociception/antinociception balance monitoring. However, its benefits in clinical practice remain unproven. The aim of this study was to evaluate the efficacy of intraoperative pupillometry monitoring on intraoperative opioid consumption and postoperative pain compared to surgical pleth index (SPI), another widely investigated monitoring.
METHODS


American Society of Anesthesiologists (ASA) I-II patients scheduled for elective laparoscopic cholecystectomy were included. This prospective, parallel-arm, single-center study was conducted in 2 steps. First, we evaluated the feasibility of using pupillometry and SPI monitoring compared with conventional hemodynamic monitoring. Next, a parallel-arm, double-blind randomized study compared the peak postoperative pain measured with numerical rating scale (NRS) from 0 (no pain) to 10 (extreme pain) as a primary outcome between pupillometry (pupillometry group, n = 43) and SPI monitoring (SPI group, n = 43) using Mann-Whitney U test. Secondary outcomes included intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications.
RESULTS


In the preliminary study (n = 50), remifentanil consumption was less under pupillometry monitoring compared to SPI monitoring, and peak postoperative pain was lower under pupillometry compared to conventional monitoring. In the main study (n = 86), peak postoperative pain and intraoperative remifentanil consumption were lower in the pupillometry group (median [first to third quartile], 5 [4-6]; mean ± standard deviation [SD], 0.078 ± 0.019 μg·kg·minute) compared to the SPI group (7 [5-8] and 0.0130 ± 0.051 μg·kg·minute; P < .001), with the median difference in peak postoperative pain of -1 and its 95% confidence interval between -2 and -0.5. The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
CONCLUSIONS


Intraoperative pupillometry monitoring reduced intraoperative remifentanil consumption and postoperative pain. It may be an alternative option for intraoperative opioid control under general anesthesia in adult patients.",2020,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","['adult patients', 'American Society of Anesthesiologists (ASA']","['elective laparoscopic cholecystectomy', 'Pupillometry With Surgical Pleth Index Monitoring', 'intraoperative pupillometry monitoring', 'conventional hemodynamic monitoring', 'surgical pleth index (SPI', 'pupillometry and SPI monitoring', 'Propofol-Remifentanil Anesthesia']","['number of analgesic administrations', 'better responsiveness to fentanyl', 'Perioperative Opioid Consumption and Nociception', 'peak postoperative pain measured with numerical rating scale (NRS', 'intraoperative remifentanil consumption and postoperative pain', 'peak postoperative pain', 'intraoperative opioid consumption and postoperative pain', 'peak postoperative pain and intraoperative remifentanil consumption', 'intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.251762,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","[{'ForeName': 'Jong Hae', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Jwa', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Choung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Yeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004958']
2222,32639389,Effects of an Intraoperative Intravenous Bolus Dose of Dexmedetomidine on Remifentanil-Induced Postinfusion Hyperalgesia in Patients Undergoing Thyroidectomy: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


Consecutive exposure to high-dose remifentanil during anesthesia may induce remifentanil-induced postinfusion hyperalgesia (RPH). Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, may have synergistic effects with opioids and aid in perioperative pain management. In this study, we hypothesized that an intraoperative bolus dose of intravenous dexmedetomidine could alleviate RPH in patients undergoing thyroidectomy under general anesthesia.
METHODS


Ninety patients undergoing thyroidectomy were randomly assigned to 1 of 3 groups: placebo, normal saline (group P); low-dose dexmedetomidine 0.2 μg·kg (group LD); or high-dose dexmedetomidine 0.5 μg·kg (group HD). Remifentanil was infused at a rate of 0.30 μg·kg·minute. Mechanical pain thresholds were measured using an Electronic von Frey device preoperatively and at 30 minutes, 6 hours, 24 hours, and 48 hours after surgery and were analyzed with 2-way repeated-measures analysis of variance (ANOVA) followed by Bonferroni post hoc comparison. We also recorded postoperative pain scores, the incidence of receiving rescue analgesics, and side effects up to 48 hours after surgery.
RESULTS


The mechanical pain thresholds around the skin incision were significantly higher in group LD compared to group P 30 minutes and 6 hours after surgery (mean ± standard deviation: [65.0 ± 25.2] vs [49.6 ± 24.4] g, mean difference [95% confidence interval]: 15.4 [0.3-30.5] g, P= .045 at 30 minutes; [65.9 ± 24.5] vs [49.3 ± 26.1] g, 16.6 [1.1-32.1] g, P= .032 at 6 hours). The pain thresholds around the skin incision were significantly higher in group HD compared to group P 30 minutes and 6 hours after surgery ([67.8 ± 21.7] vs [49.6 ± 24.4] g, 18.2 [3.1-33.3] g, P= .013 at 30 minutes; [68.3 ± 22.5] vs [49.3 ± 26.1] g, 19.0 [3.5-34.5] g, P= .011 at 6 hours). The incidence of hyperalgesia around the skin incision was lower in group HD than in group P 30 minutes and 6 hours after surgery (4 [13%] vs 14 [48%], P= .012 at 30 minutes, 4 [13%] vs 12 [41%], P= .045 at 6 hours), although no significant difference was observed between group LD and group P. Postoperative pain scores, the incidence of rescue analgesic demand, and postoperative side effects were not significantly different between the groups.
CONCLUSIONS


An intraoperative intravenous bolus dose of dexmedetomidine 0.5 μg·kg alleviates remifentanil-induced hyperalgesia in patients undergoing thyroidectomy without a significant difference in side effects.",2020,The mechanical pain thresholds around the skin incision were significantly higher in group LD compared to group P 30 minutes and 6 hours after surgery (mean ± standard deviation: [65.0 ± 25.2] vs [49.6 ± 24.4],"['patients undergoing thyroidectomy under general anesthesia', 'patients undergoing thyroidectomy', 'Ninety patients undergoing thyroidectomy', 'Patients Undergoing Thyroidectomy']","['Remifentanil', 'Dexmedetomidine', 'placebo, normal saline (group P); low-dose dexmedetomidine 0.2 μg·kg (group LD); or high-dose dexmedetomidine 0.5 μg·kg (group HD', 'remifentanil', 'dexmedetomidine']","['incidence of hyperalgesia around the skin incision', 'Postoperative pain scores, the incidence of rescue analgesic demand, and postoperative side effects', 'hyperalgesia', 'pain thresholds around the skin incision', 'mechanical pain thresholds around the skin incision', 'postoperative pain scores, the incidence of receiving rescue analgesics, and side effects', 'Mechanical pain thresholds', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",90.0,0.544179,The mechanical pain thresholds around the skin incision were significantly higher in group LD compared to group P 30 minutes and 6 hours after surgery (mean ± standard deviation: [65.0 ± 25.2] vs [49.6 ± 24.4],"[{'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Qihua', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Affiliated Shenzhen Maternal & Child Healthcare Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Tianhua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005003']
2223,32639394,PrEvention of post-traumatic contractuRes with Ketotifen 1 (PERK 1): A randomized clinical trial.,"OBJECTIVE


To assess the use of Ketotifen Fumarate (KF) to reduce post-traumatic contractures following elbow fractures and/or dislocations.
DESIGN


Randomized clinical trial.
SETTING


Three hospitals in Calgary, Canada including one Level 1 trauma center.
PARTICIPANTS


Adults (n=151) sustaining operative or non-operatively managed isolated distal humerus or proximal radius +/- ulna fractures or elbow dislocations within seven days of injury.
INTERVENTIONS


KF 5 mg (n=74) or lactose-Placebo (PL, n=77) orally twice daily for six weeks.
MAIN OUTCOMES


Primary outcome elbow flexion-extension arc range of motion (ROM) at 12 weeks post-randomization. Safety measures including serious adverse events (SAE) and radiographic fracture line disappearance from 2 to 52 weeks post-randomization.
RESULTS


The elbow ROM (mean, confidence interval) was not significantly different between KF (122°, 118°-127°) and PL (124°, 119°-130°) groups (p=0.56). There was a significant difference in elbow ROM at 12 weeks post-randomization comparing operative (117°, 112°-122°) vs non-operative groups (128°, 124°-133°) irrespective of intervention (p=0.0011). There were 11 SAE (KF=6, PL=5) that were those expected in an elbow fracture population potentially taking KF. There was no statistically significant difference in the rates of these events between the groups. The disappearance of fracture lines over time was similar between groups. There was one non-union in each group.
CONCLUSIONS


In a population of operative and non-operatively managed elbow fractures and/or dislocations KF did not reduce post-traumatic contractures. The administration of KF in this population was not found to result in a significantly higher number of major adverse events when compared to placebo.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,In a population of operative and non-operatively managed elbow fractures and/or dislocations KF did not reduce post-traumatic contractures.,"['Three hospitals in Calgary, Canada including one Level 1 trauma center', 'Adults (n=151) sustaining operative or non-operatively managed isolated distal humerus or proximal radius ']","['KF', 'Ketotifen Fumarate (KF', 'Ketotifen 1 (PERK 1', 'KF 5 mg (n=74) or lactose-Placebo (PL, n=77) orally twice daily for six weeks']","['major adverse events', 'elbow flexion-extension arc range of motion (ROM', 'disappearance of fracture lines', 'serious adverse events (SAE) and radiographic fracture line disappearance', 'elbow ROM']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0588205', 'cui_str': 'Bone structure of proximal radius'}]","[{'cui': 'C0043443', 'cui_str': 'Ketotifen fumarate'}, {'cui': 'C0022642', 'cui_str': 'Ketotifen'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0575649', 'cui_str': 'Elbow joint - range of movement'}]",151.0,0.495328,In a population of operative and non-operatively managed elbow fractures and/or dislocations KF did not reduce post-traumatic contractures.,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hildebrand', 'Affiliation': 'Professor, Department of Surgery, Deputy Director, McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Prism S', 'Initials': 'PS', 'LastName': 'Schneider', 'Affiliation': 'Clinical Associate Professor, Departments of Surgery and Community Health Sciences, McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Nicholas G H', 'Initials': 'NGH', 'LastName': 'Mohtadi', 'Affiliation': 'Clinical Professor, Department of Surgery, Cumming School of Medicine, Director, Sport Medicine Centre, Faculty of Kinesiology, University of Calgary.'}, {'ForeName': 'Ayoola', 'Initials': 'A', 'LastName': 'Ademola', 'Affiliation': 'PhD Student, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Clinical Assistant Professor, Department of Surgery, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Garven', 'Affiliation': 'Research Coordinator, Department of Surgery, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Richard E A', 'Initials': 'REA', 'LastName': 'Walker', 'Affiliation': 'Associate Professor and Head, Department of Radiology, McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary.'}, {'ForeName': 'Tolulope T', 'Initials': 'TT', 'LastName': 'Sajobi', 'Affiliation': 'Associate Professor, Departments of Community Health Sciences & Clinical Neurosciences, Cumming School of Medicine, University of Calgary.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001878']
2224,32639460,"A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants.","BACKGROUND


Pneumococcal disease remains a public health priority worldwide. This phase 2 study (V114-008; NCT02987972; EudraCT 2016-001117-25) compared safety and immunogenicity of 2 clinical lots of V114 (investigational 15-valent pneumococcal vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) to 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants (*serotypes unique to V114).
METHODS


Healthy infants 6-12 weeks old were randomized to receive a 4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13 at 2, 4, 6 and 12-15 months old. Adverse events were evaluated after each dose. Primary immunogenicity endpoint was to demonstrate noninferiority of V114 Lot 1 and V114 Lot 2 relative to PCV13 based on proportion of infants achieving serotype-specific IgG concentration ≥0.35 µg/mL for 13 serotypes shared with PCV13 at 1 month postdose 3 (PD3). Serotype-specific IgG geometric mean concentrations (GMCs) for all 15 V114 serotypes were measured at PD3, predose 4 and 1 month postdose 4 (PD4).
RESULTS


Overall, 1044 of 1051 randomized infants received ≥1 dose of vaccine (V114 Lot 1 [n = 350], V114 Lot 2 [n = 347] or PCV13 [n = 347]). Adverse events were generally comparable across groups. At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13. IgG GMCs were comparable among V114 and PCV13 recipients at PD3 and PD4. Serotype 3 responses were higher following receipt of V114 than PCV13. Both V114 lots induced higher GMCs than PCV13 to the 2 unique V114 serotypes.
CONCLUSIONS


Immunogenicity of both V114 lots was noninferior to PCV13 for all 13 shared serotypes between the 2 vaccines and displayed comparable safety and tolerability profiles to PCV13.",2020,"At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13.","['healthy infants (*serotypes unique to V114', 'Healthy infants 6-12 weeks old', 'Healthy Infants']","['4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13', 'vaccine', '13-Valent Pneumococcal Conjugate Vaccine', '13-valent pneumococcal conjugate vaccine (PCV13', 'V114 (investigational 15-valent pneumococcal vaccine']","['IgG GMCs', 'Serotype-specific IgG geometric mean concentrations (GMCs', 'Adverse events', 'safety and immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0757769', 'cui_str': 'PLAGL1 protein, human'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1051.0,0.0584867,"At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13.","[{'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Platt', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'Soroka Medical Center, Research, Beersheba, Israel.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Tapiero', 'Affiliation': 'CHU Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Clifford', 'Affiliation': 'Coastal Pediatric Research, Charleston, South Carolina.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Oakland, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hurley', 'Affiliation': 'Cottonwood Pediatrics, Research, Murray, Utah.'}, {'ForeName': 'Tulin', 'Initials': 'T', 'LastName': 'Shekar', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hurtado', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Nolan', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Camilo J', 'Initials': 'CJ', 'LastName': 'Acosta', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'McFetridge', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bickham', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Luwy K', 'Initials': 'LK', 'LastName': 'Musey', 'Affiliation': 'From the Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002765']
2225,32640669,"Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer-The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol.","The detection of molecular alterations is crucial for the individualized treatment of advanced non-small cell lung cancer (NSCLC). Missing targetable alterations may have a major impact on patient's progression free and overall survival. Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations. In the retrospective study detection rate of epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared to other standard biopsy techniques. This prospective, randomized, multicenter, single blinded study evaluates the accuracy of molecular genetic characterization of NSCLC for different cell sampling techniques. Key inclusion criteria are suspected lung cancer or the suspected relapse of known NSCLC that is bronchoscopically visible. Patients will be randomized, either to have a CB or a bronchoscopic forceps biopsy (FB). If indicated, a transbronchial needle aspiration (TBNA) of suspect lymph nodes will be performed. Blood liquid biopsy will be taken before tissue biopsy. The primary endpoint is the detection rate of molecular genetic alterations in NSCLC, using CB and FB. Secondary endpoints are differences in the combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy. This trial plans to recruit 540 patients, with 178 evaluable patients per study cohort. A histopathological and molecular genetic evaluation will be performed by the affiliated pathology departments of the national network for genomic medicine in lung cancer (nNGM), Germany. We will compare the diagnostic value of solid tumor tissue, lymph node cells and liquid biopsy for the molecular genetic characterization of NSCLC. This reflects a real world clinical setting, with potential direct impact on both treatment and survival.",2020,Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations.,"['540 patients, with 178 evaluable patients per study cohort', 'advanced non-small cell lung cancer (NSCLC', 'Non-Small Cell Lung Cancer']","['transbronchial needle aspiration (TBNA', 'Biopsy Technique', 'bronchoscopic forceps biopsy (FB']","['detection rate of molecular genetic alterations in NSCLC, using CB and FB', 'epidermal growth factor (EGFR) mutations', 'combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy']","[{'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0180936', 'cui_str': 'Biopsy forceps'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0086345', 'cui_str': 'Molecular Genetics'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4505151', 'cui_str': 'Liquid Biopsies'}]",540.0,0.125351,Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations.,"[{'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Haentschel', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckeler', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bonzheim', 'Affiliation': 'Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schimmele', 'Affiliation': 'Department of Internal Medicine, Gastroenterology and Tumor Medicine, Paracelsus Hospital, 73760 Ostfildern-Ruit, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Spengler', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Stanzel', 'Affiliation': 'Center for Pneumology, 58675 Hemer, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Petermann', 'Affiliation': 'Department for Pulmonary Diseases, Asklepios-Klinik Harburg, 21075 Hamburg, Germany.'}, {'ForeName': 'Kaid', 'Initials': 'K', 'LastName': 'Darwiche', 'Affiliation': 'Department of Interventional Pneumology, Ruhrlandklinik, University Hospital Essen, University of Duisburg-Essen, 45239 Essen, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hagmeyer', 'Affiliation': 'Clinic for Pneumology and Allergology, Center of Sleep Medicine and Respiratory Care, Hospital Bethanien Solingen, 42699 Solingen, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Buettner', 'Affiliation': 'Institute of Pathology, University Hospital of Cologne, 50937 Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Tiemann', 'Affiliation': 'Institute for Hematopathology Hamburg, 22547 Hamburg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Schildhaus', 'Affiliation': 'Department of Pathology, University Medicine Essen-Ruhrlandklinik, University Duisburg-Essen, 45147 Essen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Muche', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, 89075 Ulm, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Boesmueller', 'Affiliation': 'Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Everinghoff', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mueller', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Bijoy', 'Initials': 'B', 'LastName': 'Atique', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'NPARU, University of Worcester, Worcester WR2 6AJ, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Zender', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}, {'ForeName': 'Falko', 'Initials': 'F', 'LastName': 'Fend', 'Affiliation': 'Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hetzel', 'Affiliation': 'Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10070459']
2226,32640755,A New Nasal Restriction Device Called FeelBreathe ®  Improves Breathing Patterns in Chronic Obstructive Pulmonary Disease Patients during Exercise.,"A device called FeelBreathe (FB) ®  was designed, developed, and patented for inspiratory muscle training. The main aim was to determine the acute responses on lung ventilation, gas exchange, and heart rate during exercise in patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB. In this study, a randomized cross-over trial was performed with 18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value). Each participant randomly conducted two trials with 30 min of rest between them with the same protocol on a treadmill for 10 min at a constant rate of 50% of VO 2peak . Each test was performed randomly and in a crossover randomized design in two different conditions: (1) oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device). It was observed that FB had positive effects on dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time. Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise. The results suggest that exercise performed with FB improved ventilatory responses compared to the oronasal mode in COPD patients. This new tool could be used during most daily tasks and exercise programs.",2020,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","['patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB', '18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value', 'Chronic Obstructive Pulmonary Disease Patients during Exercise']","['Nasal Restriction Device Called FeelBreathe ®', 'oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device']","['ventilatory responses', 'blood oxygen saturation percentage, oxygen uptake, and heart rate', 'acute responses on lung ventilation, gas exchange, and heart rate', 'dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}]",,0.10336,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","[{'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11519 Cádiz, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'University Hospital Puerta del Mar. Pneumology, Allergy and Thoracic Surgery Department, 11009 Cádiz, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Pelayo A', 'Initials': 'PA', 'LastName': 'García', 'Affiliation': 'Center Sport Iberia, 29007 Málaga, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134876']
2227,32640842,Compatibility and Safety of Ultra Rapid Lispro with Continuous Subcutaneous Insulin Infusion in Patients With Type 1 Diabetes: PRONTO-Pump Study.,"Background Ultra rapid lispro (URLi) is a new insulin lispro formulation that has accelerated absorption and improved postprandial glucose control compared to insulin lispro (Humalog®). The compatibility and safety of URLi versus lispro were evaluated in patients with type 1 diabetes using continuous subcutaneous insulin infusion (CSII, insulin pump). Methods In this Phase 3, double-blind, crossover study, 49 patients were randomized to two 6-week treatment periods, following a 2-week lead-in period on lispro. Primary endpoint was the rate of infusion set failures due to a pump occlusion alarm, or unexplained hyperglycemia with blood glucose >13.9 mmol/L (250 mg/dL) that did not decrease within 1 hour following a correction bolus. Results There was no significant difference in the rate of infusion set failures between URLi and lispro (0.03 versus 0.05 events/30 days, p=0.375). A higher rate of premature infusion set changes was observed with URLi (1.13 versus 0.78 events/30 days; p=0.028), translating to 1 additional infusion set change approximately every 3 months. A trend toward improved glycemic control was observed with URLi treatment: time in range 3.9-10.0 mmol/L (71-180 mg/dL) was 65.7%±1.3% versus 63.0%±1.3%. Treatment-emergent adverse events (TEAEs) were reported by 46.9% of patients on URLi treatment and 18.8% on lispro. This difference was driven by an increase in infusion site reactions - over 90% were mild. Incidence of all other TEAEs and severe hypoglycemia was similar between treatments. Conclusions URLi was compatible with insulin pump use with a safety profile similar to lispro.",2020,"There was no significant difference in the rate of infusion set failures between URLi and lispro (0.03 versus 0.05 events/30 days, p=0.375).","['49 patients', 'patients with type 1 diabetes using continuous subcutaneous insulin infusion (CSII, insulin pump', 'Patients With Type 1 Diabetes']","['URLi versus lispro', ' Ultra rapid lispro (URLi', 'Ultra Rapid Lispro with Continuous Subcutaneous Insulin Infusion']","['infusion site reactions', 'rate of premature infusion set changes', 'rate of infusion set failures due to a pump occlusion alarm, or unexplained hyperglycemia with blood glucose', 'rate of infusion set failures', 'compatibility and safety', 'Incidence of all other TEAEs and severe hypoglycemia', 'glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}]","[{'cui': 'C1096343', 'cui_str': 'Infusion site reaction'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",49.0,0.104417,"There was no significant difference in the rate of infusion set failures between URLi and lispro (0.03 versus 0.05 events/30 days, p=0.375).","[{'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Bruce Bode, 1800 Howell Mill Rd, Suite 450, Atlanta, Georgia, United States, 30318.'}, {'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'University of Colorado Denver Barbara Davis Center for Childhood Diabetes, 21610, Department of Medicine and Pediatrics, Denver, Colorado, United States; SATISH.GARG@CUANSCHUTZ.EDU.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Norwood', 'Affiliation': 'Valley Research, Fresno, California, United States; drpaulnorwood@gmail.com.'}, {'ForeName': 'Cristobal', 'Initials': 'C', 'LastName': 'Morales', 'Affiliation': 'Hospital Universitario Virgen Macarena, 16582, UGC Endocrinologia y Nutrición., Sevilla, Andalucía, Spain; cr.morales@hotmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hardy', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; hardy_thomas_a@lilly.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, 1539, Indianapolis, Indiana, United States; liu_rong_rl@lilly.com.'}, {'ForeName': 'Debra Ann', 'Initials': 'DA', 'LastName': 'Ignaut', 'Affiliation': 'Eli Lilly and Company, Medical, Lilly Corporate Center, Indianapolis, Indiana, United States, 46285; dignaut@lilly.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0224']
2228,32640846,Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study.,"BACKGROUND


Young adults with type 1 diabetes (T1D) tend to have higher A1C than older adults and are at increased risk for diabetic ketoacidosis (DKA). Oral adjuncts to insulin have not been previously studied in this population.
METHODS


In this phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, adults aged 18-30 years with T1D and A1C ≥9.0% were randomly assigned to placebo (n=42) or sotagliflozin 400 mg (n=43) in addition to insulin for 12 weeks. Insulin doses were adjusted to meet glucose targets (preprandial 80-130 mg/dL, postprandial <180 mg/dL). The primary endpoint was change from baseline in A1C at Week 12.
RESULTS


From a baseline of 9.8%, mean A1C decreased by 1.0% with placebo and 1.3% with sotagliflozin ( 0.4% [95% confidence interval (CI) 0.8 to 0.1]; P=0.10 vs placebo). In the prespecified A1C ≤10.0% subgroup, the treatment difference was 0.8% ( 1.3 to 0.2; P=0.006), favoring sotagliflozin. Overall, relative to placebo, postprandial glucose (PPG) decreased by 56.6 mg/dL (-89.7 to -23.6; P<0.001) and weight by 2.37 kg ( 3.5 to 1.2; P<0.001). More patients achieved an A1C <7.0% with sotagliflozin (16.3%) than placebo (2.4%; P=0.026). Rates of documented hypoglycemia and severe hypoglycemia were similar between groups. One DKA event occurred with placebo and none with sotagliflozin.
CONCLUSIONS


In young adults with T1D and suboptimal glycemic control, sotagliflozin plus insulin for 12 weeks numerically improved A1C and significantly improved A1C goal attainment, PPG, and body weight. Sotagliflozin plus insulin was generally well tolerated without any episodes of DKA (NCT02383940).",2020,"Overall, relative to placebo, postprandial glucose (PPG) decreased by 56.6 mg/dL","['adults aged 18-30 years with T1D and A1C ≥9.0', 'Young adults with type 1 diabetes (T1D', 'Young Adults with Poorly Controlled Type 1 Diabetes']","['Sotagliflozin Combined with Intensive Insulin Therapy', 'sotagliflozin', 'sotagliflozin 400 mg (n=43) in addition to insulin', 'dL', 'placebo']","['Rates of documented hypoglycemia and severe hypoglycemia', 'mean A1C', 'A1C goal attainment, PPG, and body weight', 'Overall, relative to placebo, postprandial glucose (PPG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",,0.681334,"Overall, relative to placebo, postprandial glucose (PPG) decreased by 56.6 mg/dL","[{'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Bruce Bode, 1800 Howell Mill Rd, Suite 450, Atlanta, Georgia, United States, 30318.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Yale University School of Medicine, Pediatric Endocrinology, 333 Cedar St., LMP 3103E, New Haven, Connecticut, United States, 06520; Eda.Cengiz@yale.edu.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'University of Colorado Denver Barbara Davis Center for Childhood Diabetes, 21610, Denver, Colorado, United States; PAUL.WADWA@CUANSCHUTZ.EDU.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals Inc, 57636, The Woodlands, Texas, United States; pbanks@lexpharma.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinderkrankenhaus auf der Bult, Diabetes Centre for Children and Adolescents, Janusz-Korczak Allee 12, Hannover, Germany, 30173; danne@hka.de.'}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Kushner', 'Affiliation': 'McNair Interests, McNair Medical Institute, 109 N. Post Oak Lane, Houston, Houston, Texas, United States, 77024; jake.kushner@mac.com.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical School, 25989, Dallas, Texas, United States; Darren.McGuire@UTSouthwestern.edu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, California, United States; momofmax@mac.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Strumph', 'Affiliation': 'Metavant Sciences, Inc, Durham, North Carolina, United States; pstrumph@gmail.com.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals Inc, 57636, The Woodlands, Texas, United States; sangeetasawhney98@gmail.com.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0079']
2229,32640854,Modulation of the prefrontal blood oxygenation response to intermittent theta-burst stimulation in depression: A sham-controlled study with functional near-infrared spectroscopy.,"OBJECTIVE


To better understand the neural mechanisms behind the effect of intermittent theta-burst stimulation (iTBS), we investigated how the prefrontal blood oxygenation response measured by changes in oxygenated haemoglobin (oxy-Hb) was modulated during a sham-controlled iTBS treatment course, and whether this was related to depressive symptom change.
METHODS


In this randomised, double-blind study, patients with ongoing treatment-resistant depression received either active ( n  = 18) or sham ( n  = 21) iTBS over the dorsomedial prefrontal cortex for ten to fifteen days with two sessions daily. Event-related functional near-infrared spectroscopy (fNIRS) was measured during each iTBS train, and resting-state oxy-Hb was compared before and after each iTBS session at the first, fifth, and last treatment day.
RESULTS


Patients receiving active iTBS had an increase of the event-related oxy-Hb response compared to the sham group on the fifth (bilateral prefrontal cortices  p  < .001) and last (left prefrontal  p  = .007, right prefrontal  p  = .025) treatment day. Resting-state analysis showed suppressed oxy-Hb change in active iTBS compared to sham iTBS on the last treatment day ( p  = .024). Oxy-Hb change was unrelated to depressive symptom change ( p  = .474).
CONCLUSIONS


This study describes a modulation of the blood oxygenation response over the prefrontal cortex that was built up during the course of active iTBS treatment in depression.",2020,"RESULTS


Patients receiving active iTBS had an increase of the event-related oxy-Hb response compared to the sham group on the fifth (bilateral prefrontal cortices  p  < .001) and last (left prefrontal  p  = .007, right prefrontal  p  = .025) treatment day.","['patients with ongoing treatment-resistant depression received either', 'depression']","['active ( n \u2009=\u200918) or sham ( n \u2009=\u200921) iTBS', 'intermittent theta-burst stimulation (iTBS', 'intermittent theta-burst stimulation']","['blood oxygenation response', 'depressive symptom change', 'oxy-Hb change in active iTBS', 'event-related oxy-Hb response', 'prefrontal blood oxygenation response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.141215,"RESULTS


Patients receiving active iTBS had an increase of the event-related oxy-Hb response compared to the sham group on the fifth (bilateral prefrontal cortices  p  < .001) and last (left prefrontal  p  = .007, right prefrontal  p  = .025) treatment day.","[{'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Weigl', 'Affiliation': 'Department of Surgical Science, Anaesthesiology and Intensive Care, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2020.1785007']
2230,32640881,Poststroke shoulder pain in subacute patients and its correlation with upper limb recovery after robotic or conventional treatment: A secondary analysis of a multicenter randomized controlled trial.,"BACKGROUND AND AIMS


Poststroke shoulder pain is a common complication. We aimed to investigate the prevalence of poststroke shoulder pain, with attention to the neuropathic component, and the relationship between poststroke shoulder pain and upper limb improvement in motor function, strength, disability, and quality of life after upper limb rehabilitation.
METHODS


This is a secondary analysis of a multicenter randomized controlled trial to compare upper limb conventional or robotic rehabilitation on 224 patients enrolled in eight rehabilitation centers. We assessed poststroke shoulder pain (using the Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0), after 30 rehabilitation sessions (T1), and three months after the end of rehabilitation (T2).
RESULTS


A moderate/severe poststroke shoulder pain was reported by 28.9% of patients, while 19.6% of them showed a neuropathic component. At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life. Moderate/severe pain and neuropathic component significantly reduced after both treatments and this reduction was maintained at T2. Finally, the intensity of pain at baseline was negatively correlated with the improvement of upper limb motor function.
CONCLUSIONS


Poststroke shoulder pain negatively impact on motor performance, strength, disability, and physical aspects of the quality of life as well as on upper limb motor recovery; however, it can be reduced after a robotic or a conventional rehabilitation. Therefore, we suggest considering poststroke shoulder pain when planning the rehabilitation intervention.",2020,"At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life.","['224 patients enrolled in eight rehabilitation centers', 'subacute patients']","['robotic or conventional treatment', 'upper limb conventional or robotic rehabilitation']","['severe poststroke shoulder pain', 'Poststroke shoulder pain', 'time since stroke and disability', 'motor performance, strength, disability, and physical aspects of the quality of life', 'Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0', 'intensity of pain', 'motor function, strength, disability, and quality of life', 'poststroke shoulder pain', 'Moderate/severe pain and neuropathic component']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",224.0,0.0936727,"At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Aprile', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cruciani', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pecchioli', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loreti', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Galeri', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diverio', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falsini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Langone', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Carrozza', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020937192']
2231,32640882,Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial.,"BACKGROUND


Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention.
AIM


To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter).
METHODS


We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group.
RESULTS


Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69-2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation.
CONCLUSIONS


Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke.  Clinical Trial Registration:  URL https://clinicaltrials.gov/ct2/show/NCT02578979 Unique Identifiers: NCT02578979.",2020,"Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation.
","['elderly patients with acute ischemic stroke', 'from October 2015 to October 2018 at six hospitals', 'acute ischemic stroke patients', 'Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission', 'acute ischemic stroke patients without known atrial fibrillation']",['serial electrocardiograms versus 24-h Holter'],"['newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group', 'detection rates of paroxysmal atrial fibrillation', 'detection of paroxysmal atrial fibrillation', 'atrial fibrillation', 'detection rate of paroxysmal atrial fibrillation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.248161,"Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation.
","[{'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Feng', 'Initials': 'SF', 'LastName': 'Sung', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Ditmanson Medical Foundation, Chia-Yi Christian Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Sung-Chun', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Stroke Center and Department of Neurology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Hsuan', 'Initials': 'KH', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Yung-Sung', 'Initials': 'YS', 'LastName': 'Huang', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Jiann-Der', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Jiann-Shing', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Stroke Center and Department of Neurology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chang-Min', 'Initials': 'CM', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Chiayi Branch, Chiayi, Taiwan.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Miaoli County, Taiwan.'}, {'ForeName': 'Tsung-Ta', 'Initials': 'TT', 'LastName': 'Hsieh', 'Affiliation': 'Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ovbiagele', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020938297']
2232,32640940,Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage.
METHODS


We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge.
RESULTS


In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86];  P =0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%;  P =0.025). There was no significant difference in mortality between the groups.
CONCLUSIONS


GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.",2020,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","['108 patients', 'After Aneurysmal Subarachnoid Hemorrhage', 'Patients >18 years of age with an aneurysmal subarachnoid hemorrhage']","['standard therapy or GDHT', 'GDHT', 'goal-directed hemodynamic therapy (GDHT', 'Goal-Directed Therapy']","['rate of DCI after subarachnoid hemorrhage', 'GOS', 'Glasgow Outcome Scale (GOS', 'occurrence of DCI', 'mortality', 'Delayed Ischemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",108.0,0.182296,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86];  P =0.02).","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Germany. (J.G., F.R., B.M., Y.-M.R., M.W.).'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Germany. (J.G., F.R., B.M., Y.-M.R., M.W.).'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Germany. (J.G., F.R., B.M., Y.-M.R., M.W.).'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Ryang', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Germany. (J.G., F.R., B.M., Y.-M.R., M.W.).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Germany. (J.G., F.R., B.M., Y.-M.R., M.W.).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology, Klinikum rechts der Isar, Technical University Munich, Germany. (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.).'}]",Stroke,['10.1161/STROKEAHA.120.029279']
2233,32640945,High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source.,"BACKGROUND AND PURPOSE


Optimal secondary prevention for patients with embolic stroke of undetermined source (ESUS) remains unknown. We aimed to assess whether high-sensitivity cardiac troponin T (hs-cTnT) levels are associated with major vascular events and whether hs-cTnT may identify patients who benefit from anticoagulation following ESUS.
METHODS


Data were obtained from the biomarker substudy of the NAVIGATE ESUS trial, a randomized controlled trial testing the efficacy of rivaroxaban versus aspirin for secondary stroke prevention in ESUS. Patients were dichotomized at the hs-cTnT upper reference limit (14 ng/L, Gen V, Roche Diagnostics). Cox proportional hazard models were computed to explore the association between hs-cTnT, the combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke.
RESULTS


Among 1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21%. During a median follow-up of 11 months, the combined cardiovascular end point occurred in 68 patients (5.0%/y, rivaroxaban 28 events, aspirin 40 events; hazard ratio, 0.67 [95% CI, 0.41-1.1]), and recurrent ischemic stroke occurred in 50 patients (4.0%/y, rivaroxaban 16 events, aspirin 34 events, hazard ratio 0.45 [95% CI, 0.25-0.81]). Annualized combined cardiovascular end point rates were 8.2% (9.5% rivaroxaban, 7.0% aspirin) for those above hs-cTnT upper reference limit and 4.8% (3.1% rivaroxaban, 6.6% aspirin) below with a significant treatment modification ( P =0.04). Annualized ischemic stroke rates were 4.7% above hs-cTnT upper reference limit and 3.9% below, with no suggestion of an interaction between hs-cTnT and treatment ( P =0.3).
CONCLUSIONS


In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates. While fewer recurrent strokes occurred in patients receiving rivaroxaban, outcomes were not stratified by hs-cTn results. Our findings support using hs-cTnT for cardiovascular risk stratification but not for decision-making regarding anticoagulation therapy in patients with ESUS.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","['secondary stroke prevention in ESUS', '1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21', 'patients with ESUS', 'patients with embolic stroke of undetermined source (ESUS', 'patients who benefit from anticoagulation following ESUS', 'Patients With Embolic Stroke of Undetermined Source']","['rivaroxaban', 'High-Sensitivity Cardiac Troponin T', 'rivaroxaban versus aspirin']","['combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke', 'cardiovascular event rates', 'Annualized combined cardiovascular end point rates', 'recurrent strokes', 'recurrent ischemic stroke', 'Annualized ischemic stroke rates']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1337.0,0.250989,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","[{'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Scheitz', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Pare', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (G.P.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland (A.C.).'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Nolte', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Research & Development, Pharmaceuticals, Bayer U.S., LLC, Whippany (S.D.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krahn', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.029628']
2234,32640956,Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low-Dose Estrogen on Atrophic Vaginitis.,"INTRODUCTION


Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated effects of fenugreek extract on atrophic vaginitis.
MATERIALS AND METHODS


This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of vaginal maturation index (VMI).
FINDINGS


After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49 in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001).
CONCLUSION


The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis but it was not as effective as ultra-low-dose estrogen.",2020,This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001).,"['Atrophic Vaginitis', '60 postmenopausal women in Ardabil, Iran, in 2018', 'postmenopausal women']","['Fenugreek Vaginal Cream and Ultra Low-Dose Estrogen', 'conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens', 'fenugreek extract']","['vaginal maturation index (VMI', 'mean (standard error) score for atrophic vaginitis signs', 'atrophic vaginitis', 'VMI', 'symptoms of itching, burning, dyspareunia, and postmenopausal bleeding', 'Atrophic vaginitis']","[{'cui': 'C0156409', 'cui_str': 'Postmenopausal atrophic vaginitis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517467', 'cui_str': '0.625'}, {'cui': 'C0179108', 'cui_str': 'Applicator'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0156409', 'cui_str': 'Postmenopausal atrophic vaginitis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]",60.0,0.0493959,This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001).,"[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Hakimi', 'Affiliation': 'Tabriz University of Medical Science, Midwifery, Tabriz. Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Delazar', 'Affiliation': 'Tabriz University of Medical Science, Midwifery, Tabriz. Iran.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mobaraki-Asl', 'Affiliation': 'Ardabil University of Medical Science, Ardabil. Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'Ardabil University of Medical Science, Ardabil. Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Tavassoli', 'Affiliation': 'Ardabil University of Medical Science, Ardabil. Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Safari', 'Affiliation': 'Tabriz University of Medical Science, Midwifery, Tabriz. Iran.'}]",Current drug delivery,['10.2174/1567201817666200708112655']
2235,32641012,Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.,"BACKGROUND


Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury.
METHODS


To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O 2  with 60s intervals at 20.9% O 2 ) or daily SHAM (15, 90s episodes at 20.9% O 2  with 60s intervals at 20.9% O 2 ) intervention. The ambulatory group receives either 60-min walking practice (WALK), daily AIH + WALK, or daily SHAM+WALK intervention. Our primary outcome measures assess overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test). For safety, we also measure levels of pain, spasticity, systemic hypertension, and autonomic dysreflexia. We record outcome measures at baseline, days 5 and 10, and follow-ups at 1 week, 1 month, 6 months, and 12 months post-treatment.
DISCUSSION


The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.",2020,More persistent walking recovery may occur following repetitive (weeks),"['85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group', 'persons with SCI', 'persons with subacute spinal cord injury', 'persons with more acute SCI', 'persons with chronic (>\u20091\u2009year) SCI', 'persons with traumatic, subacute SCI', 'persons with sub-acute SCI (<\u200912\u2009months) SCI', 'persons recovering from traumatic incomplete spinal cord injury (SCI']","['Daily acute intermittent hypoxia', 'SHAM', '60-min walking practice (WALK), daily AIH\u2009+\u2009WALK, or daily SHAM+WALK intervention', 'placebo']","['walking function', 'overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test', 'pain, spasticity, systemic hypertension, and autonomic dysreflexia']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021589', 'cui_str': 'Artificial insemination, homologous'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}]",85.0,0.134924,More persistent walking recovery may occur following repetitive (weeks),"[{'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Naidu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Peters', 'Affiliation': 'Department of Rehabilitation & Movement Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Andrew Q', 'Initials': 'AQ', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Barth', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Crane', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Link', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Spaulding Research Institute, Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Hayes', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Slocum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Zafonte', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Trumbower', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, 1575 Cambridge Street, Boston, MA, 02138, USA. randy.trumbower@mgh.harvard.edu.'}]",BMC neurology,['10.1186/s12883-020-01851-9']
2236,32641023,Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.,"BACKGROUND


In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative.
METHODS


This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment.
DISCUSSION


This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors.
TRIAL REGISTRATION


Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.",2020,"This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness.","['patients who have completed primary treatment for localized prostate cancer', 'Prospectively registered on 11 June 2018', 'localized prostate cancer survivors', 'Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N\u2009=\u2009195) or', 'localized prostate cancer']","['general practitioner-based (N\u2009=\u2009195) follow-up care', 'specialist-based follow-up care compared to general practitioner-based follow-up care', 'specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.114065,"This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness.","[{'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Wollersheim', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Kristel M', 'Initials': 'KM', 'LastName': 'van Asselt', 'Affiliation': 'Department of General Practice, Amsterdam UMC location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, Antoni van Leeuwenhoek Hospital, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk C P M', 'Initials': 'HCPM', 'LastName': 'van Weert', 'Affiliation': 'Department of General Practice, Amsterdam UMC location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hauptmann', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.'}, {'ForeName': 'Annelies H', 'Initials': 'AH', 'LastName': 'Boekhout', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands. a.boekhout@nki.nl.'}]",BMC cancer,['10.1186/s12885-020-07112-9']
2237,32641079,Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol.,"BACKGROUND


Blood from younger individuals has been shown to improve physiological function in recipients in laboratory research, and many proteins from human peripheral blood show antisenescence capabilities. Thus, researchers have questioned whether blood from young donors is superior to blood from older donors. Blood transfusion is a key supportive therapy for trauma patients, and recent studies have reported the influence of blood donor age on recipient patient prognosis. Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups. The reasons for this discrepancy are complicated, but the fact that data were not obtained from randomized controlled trial (RCT) data should be considered. The current protocol and analysis method provide a feasible RCT design to evaluate the prognosis of severely ill surgery patients who were transfused with blood products from blood donors of different ages.
METHODS


The current study is a pragmatic multicenter RCT (open, parallel-group, non-masked, superiority trial). Recruited surgery intensive care unit patients will be randomized into three groups and transfused with blood products from male donors of different ages (< 25, 25-45, and > 45 years). Survival time will be measured within 28 days. The survival characteristics, possible interaction between variables, and potential factors associated with death will be analyzed by Kaplan-Meier analysis, two-way ANOVA, and Cox proportional hazards model, respectively.
TRIAL REGISTRATION


ChiCTR: ChiCTR190002. Registered on 22 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36867 .",2020,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","['trauma patients', 'from male donors of different ages (<\u200925, 25-45, and\u2009>\u200945\u2009years', 'Recruited surgery intensive care unit patients', 'severely ill surgery patients who were transfused with blood products from blood donors of different ages']",['transfused with blood products'],"['Survival time', 'survival']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}]","[{'cui': 'C0456388', 'cui_str': 'Blood product'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.182186,"Although some retrospective results found that blood from young donors improves survival, no influence of blood donor age was observed on outcomes in other study groups.","[{'ForeName': 'Xianfei', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': ""School of Medicine, Northwest University, Xi'an, 710069, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Transfusion Medicine, Third Affiliated Hospital of Guangxi Medical University, Nanning, 530031, China.'}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Chenxing', 'Initials': 'C', 'LastName': 'Da', 'Affiliation': ""Department of Endocrinology, Shaanxi Corps Hospital, Chinese People's Armed Police Forces, Xi'an, 710054, China.""}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Statistics, Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ""Department of Digestive Surgery, Xijing Hospital, Xi'an, 710032, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Dongjian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Transfusion Medicine, 908th Hospital of PLA, Yingtan, 335000, China. dearwdj@163.com.'}, {'ForeName': 'Xingbin', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Transfusion Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China. hxbyqh@163.com.""}]",Trials,['10.1186/s13063-020-04452-6']
2238,32641081,Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial.,"BACKGROUND


Current guidelines recommend the prescription of immune-enriched oral nutritional supplements for malnourished patients before major gastrointestinal surgery. However, the benefit of preoperative immunonutrition is still controversial. This randomized controlled trial aims to evaluate the effect of preoperative immunonutrition on the outcomes of surgery for colon cancer.
METHODS/DESIGN


Patients with primary colon cancer will be included as study participants after screening. They will be randomly assigned (in a ratio of 1:1) to receive preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm). Patients in the experimental arm will receive oral supplementation (400 mL/day) with arginine and ω-3 fatty acids for 7 days before elective surgery. The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome. The authors hypothesize that the rate of infectious complications would be 13% in the experimental arm and 30% in the control arm. With a two-sided alpha of 0.05 and a power of 0.8, the sample size is calculated as 176 patients (88 per arm).
DISCUSSION


Although there have been many studies demonstrating significant benefits of preoperative immunonutrition, these were limited by a small sample size and potential publication bias. Despite the recommendation of immunonutrition before surgery in nutritional guidelines, its role in reduction of rate of infectious complications is still controversial. This trial is expected to provide evidence for the benefits of administration of preoperative immunonutrition in patients with colon cancer.
TRIAL REGISTRATION


Clinical Research Information Service KCT0003770 . Registered on 15 April 2019.",2020,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","['colon cancer surgery', 'Patients with primary colon cancer will be included as study participants after screening', '176 patients (88 per arm', 'malnourished patients before major gastrointestinal surgery', 'patients with colon cancer']","['oral supplementation', 'arginine and ω-3 fatty acids', 'preoperative immunonutrition added to the normal diet (experimental arm) or consume normal diet alone (control arm', 'preoperative immunonutrition']","['postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome', 'rate of infectious complications']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.261072,"The primary endpoint is the rate of infectious complications, while the secondary endpoints are postoperative complication rate, change in body weight, length of hospital stay, and nature of fecal microbiome.","[{'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Seung-Seop', 'Initials': 'SS', 'LastName': 'Yeom', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Chang Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea.'}, {'ForeName': 'Hyeong Rok', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-ro Hwasun-eup, Hwasun-gun, Jeonnam, 58128, South Korea. drkhr@jnu.ac.kr.'}]",Trials,['10.1186/s13063-020-04544-3']
2239,32641090,Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial.,"BACKGROUND


With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated.
METHODS


Using a 2 × 2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2 years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2 min with guidance, 4-min blind, or 4 min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3.
DISCUSSION


This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4 min.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.",2020,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","['Five hundred adult nontraumatic OHCAs', 'out-of-hospital cardiac arrest']","['chest compression cycle length and real-time feedback with a CPRmeter®', 'CC guidance']","['chest compression quality', 'suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause', 'Survival', 'Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device', 'depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3', 'survival rate']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2.0,0.0745678,"Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause.","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Buléon', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France. buleon-c@chu-caen.fr.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Morilland-Lecoq', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Unité de Biostatistiques et de Recherche Clinique, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Halbout', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cesaréo', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Dubien', 'Affiliation': 'Department of Emergency Medicine, SAMU 69, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Jardel', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boyer', 'Affiliation': 'SAMU Amiens, CHU Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Husson', 'Affiliation': 'Emergency Medicine Department and SAMU 59, Lille University Hospital, Lille, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Andriamirado', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Evreux, Evreux, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Benet', 'Affiliation': 'Emergency Department, Centre Hospitalier du Havre, Le Havre, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morel-Marechal', 'Affiliation': ""Emergency Department, Centre Hospitalier d'Elbeuf Louviers Val-de-Reuil, Elbeuf, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Aubrion', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Muntean', 'Affiliation': 'Emergency Department, Centre Hospitalier de Cherbourg, Cherbourg, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Dupire', 'Affiliation': 'Emergency Department, Centre Hospitalier de Valenciennes, Valenciennes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roupie', 'Affiliation': 'UNICAEN, CHU de Caen Normandie, Pôle Réanimations-Anesthésie-SAMU, Normandie University, 14000, Caen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Hubert', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vilhelm', 'Affiliation': 'University Lille, EA 2694 - Santé Publique: Épidémiologie et Qualité des Soins, F-59000, Lille, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Gueugniaud', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, SAMU 76, Rouen University Hospital, Rouen Cedex, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04536-3']
2240,32641091,"Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study.","BACKGROUND


The outbreak of COVID-19 (caused by SARS-Cov-2) is very serious, and no effective antiviral treatment has yet been confirmed. The adage ""old drug, new trick"" in this context may suggest the important therapeutic potential of existing drugs. We found that the lopinavir/ritonavir treatment recommended in the fifth edition of the Treatment Plan of China can only help to improve a minority of throat-swab nucleic-acid results (3/15) in hospitals. Our previous use of chloroquine to treat patients with COVID-19 infection showed an improvement in more throat-swab nucleic-acid results (5/10) than the use of lopinavir/ritonavir.
METHODS/DESIGN


This is a prospective, open-label, randomized controlled, multicenter clinical study. The study consists of three phases: a screening period, a treatment period of no more than 10 days, and a follow-up period for each participant. Participants with COVID-19 infection who are eligible for selection for the study will be randomly allocated to the trial group or the control group. The control group will be given lopinavir/ritonavir treatment for no more than 10 days. The trial group will be given chloroquine phosphate treatment for no more than 10 days. The primary outcome is the clinical recovery time at no more than 28 days after the completion of therapy and follow-up. The secondary outcomes include the rate of treatment success after the completion of therapy and follow-up, the time of treatment success after no more than 28 days, the rate of serious adverse events during the completion of therapy and follow-up, and the time to return to normal temperature (calculated from the onset of illness) during the completion of therapy and follow-up. Comparisons will be performed using two-sided tests with a statistical significance level of 5%.
DISCUSSION


This experiment should reveal the efficacy and safety of using chloroquine versus lopinavir/ritonavir for patients with mild/general COVID-19 infection. If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR2000029741 . Registered on 11 February 2020.",2020,"If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
","['patients with mild/general COVID-19 infection', 'Participants with COVID-19 infection who are eligible for selection for the study', 'mild/general COVID-19 infection']","['lopinavir/ritonavir', 'chloroquine', 'chloroquine phosphate', 'chloroquine versus lopinavir/ritonavir']","['clinical recovery time', 'time to return to normal temperature', 'rate of treatment success after the completion of therapy and follow-up, the time of treatment success', 'efficacy and safety', 'rate of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0055447', 'cui_str': 'Chloroquine phosphate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0231262', 'cui_str': 'Temperature normal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0816284,"If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Hongqiong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Gongqi', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hospital Infection Control, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Shaoxuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Office of Clinical Research Center, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Yaoyong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Mingxing', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. huangmx5@mail.sysu.edu.cn.'}, {'ForeName': 'Zhongsi', 'Initials': 'Z', 'LastName': 'Hong', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. hongzhs@sysu.edu.cn.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. xiajinyu@mail.sysu.edu.cn.'}]",Trials,['10.1186/s13063-020-04478-w']
2241,32641094,"Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial.","BACKGROUND


The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level.
METHODS/DESIGN


The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0.
DISCUSSION


The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana.
ETHICAL CLEARANCE


NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019.",2020,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","['some rural communities of Fanteakwa North district, Ghana', '8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana']","['track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS', 'provider and community interventions', 'subsidized malaria rapid diagnostic test (mRDT) kits', 'OTCMS']","['adherence to national malaria treatment guidelines and recommended mRDT retail price', 'proportion of children under 10\u2009years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",8.0,0.164506,"In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately.","[{'ForeName': 'Olajoju Temidayo', 'Initials': 'OT', 'LastName': 'Soniran', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abuaku', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana. babuaku@noguchi.ug.edu.gh.'}, {'ForeName': 'Collins Stephen', 'Initials': 'CS', 'LastName': 'Ahorlu', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana.'}]",Trials,['10.1186/s13063-020-04509-6']
2242,32641096,Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial.,"BACKGROUND


Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking.
METHODS


Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment).
DISCUSSION


A prospective study has found a success rate at 35% for anterior colporraphy based on a combined definition, both anatomic and functional, as recently recommended. However, the definition of anatomic was strict (POP-Q< 2), while it seems that the best definition of anatomic success is ""no prolapse among the hymen"", that is to say Aa and Ba points from the POP-Q classification < 0. We hypothesize that vaginal patch plastron will have a better anatomic and functional success comparatively to anterior colporraphy because native tissue is added, as it corrects both median and lateral cystoceles thanks to bilateral paravaginal suspension.
TRIAL REGISTRATION


CHU LIMOGES is the sponsor of this research (n°87RI18_0013). This research is supported by the French Department of Health (PHRC 2018-A03476-49) and will be conducted with the support of DGOS (PHRC interregional - GIRCI SOHO). The study protocol was approved by the Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019. The trial is registered in the ClinicalTrials.gov registry ( NCT03875989 ).",2020,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"['Human Subjects Protection Review Board (Comité de Protection des Personnes) on May 16, 2019']","['anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support', 'vaginal native tissue repair']",['success rate 1\u2009year after surgery with a composite of objective and subjective measures (Aa and Ba points\u2009<\u20090 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C0447612', 'cui_str': 'Vaginal wall'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.141485,Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lacorre', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France. aymlacorre@hotmail.fr.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vidal', 'Affiliation': 'Pôle Femme Mère Couple, Hôpital Paule de Viguier, CHU Purpan, 330 avenue de Grande Bretagne, 31059, Toulouse, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Campagne-Loiseau', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Clermont-Ferrand Estaing, 1 place Lucie Aubrac, 63100, Clermont-Ferrand, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Marin', 'Affiliation': 'Institute of Neurological Epidemiology and Tropical Neurology, Faculté de Médecine de Limoges, 2 rue du Docteur Marcland, 87025, Limoges, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Aubard', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Siegerth', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Tulle, 3 place Maschat, 19000, Tulle, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mesnard', 'Affiliation': 'Department of Gynecology and Obstetrics, Hôpital de Brive-La-Gaillarde, 3 boulevard Dr Verlhac, 19100, Brive-La-Gaillarde, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chantalat', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Toulouse Rangueil, 1 avenue du Professeur Jean Poulhès, 31400, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hocke', 'Affiliation': ""Department of Gynecology and Obstetrics, CHU Bordeaux Pellegrin, Centre Aliénor d'Aquitaine, Place Amélie Raba Léon, 33076, Bordeaux, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': 'Department of Gynecology and Obstetrics, CHU Limoges, 8 avenue Dominique Larrey, 87042, Limoges Cedex, France.'}]",Trials,['10.1186/s13063-020-04512-x']
2243,32634886,[Effect of systemic use of amoxicillin and metronidazole during mechanical therapy on the periodontal microorganisms in subgingival plaque and saliva of patients with aggressive periodontitis].,"Objective:  To explore the effect of systemic use of amoxicillin and metronidazole during mechanical therapy on the clinical parameters of the first molars and periodontal microorganisms in subgingival plaque and saliva in patients with generalized aggressive periodontitis (GAgP).  Methods:  A total of 23 GAgP patients were recruited from Peking University School and Hospital of Stomatology from January 2006 to December 2009 and then randomly divided into two groups according to random number table: 12 patients received scaling and root planning (SRP) only and 11 patients received SRP combined with systemic administration of antibiotics (amoxicillin and metronidazole for a week after supragingival scaling). Clinical examination of periodontal parameters and collection of saliva and pooled subgingival plaque samples from mesial-buccal sites of 4 first molars were performed before initial therapy and 2, 4 and 6 months respectively after mechanical therapy, and saliva samples were also collected 2 weeks after therapy. Eight different periodontal microorganisms were detected in these samples by PCR. In addition, semiquantitative analysis of red complex microorganisms [ Porphyromonas gingivalis  (Pg),  Tannerella forsythia  (Tf),  Treponema denticola  (Td)] was performed.  Results:  Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars. Meanwhile the PD of antibiotics group [(4.21±1.50), (4.00±1.54), (3.84±1.89) mm of 2, 4 and 6 months respectively after therapy] was significantly lower than the SRP group [(5.29±1.27), (5.30±1.34), (4.98±1.36) mm of 2, 4 and 6 months respectively after therapy] at 3 different time points after mechanical therapy ( P <0.05). In the antibiotics group, the quantities of Pg, Tf and Td in subgingival plaque samples (the median quantity decreased to 0.0 ng at 2, 4 and 6 months after therapy) and saliva samples (the median quantity of Tf and Td decreased to 0.0 ng at 2, 4 and 6 months after therapy ( P <0.05), and the median quantity of Pg decreased to 16.3, 59.6 and 22.4 ng at 2, 4 and 6 months respectively after therapy) significantly decreased at 3 different time points after mechanical therapy compared with before therapy ( P< 0.05). While in the SRP group, there were no significant changes in the quantities of Tf and Td in saliva at 2, 4 and 6 months after mechanical therapy ( P >0.05) , and the quantities of Tf and Td in subgingival plaque significantly decreased only at 2 months after therapy ( P <0.05).  Conclusions:  SRP combined with systemic administration of amoxicillin and metronidazole could achieve greater improvement in PD of first molars and better control of the amounts of red complex microorganisms in the saliva and subgingival plaque of GAgP patients over a 6-month period.",2020,"Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars.","['patients with generalized aggressive periodontitis (GAgP', 'mesial-buccal sites of 4 first molars', '23 GAgP patients were recruited from Peking University School and Hospital of Stomatology from January 2006 to December 2009', 'patients with aggressive periodontitis']","['SRP', 'scaling and root planning (SRP', 'amoxicillin and metronidazole', 'SRP combined with systemic administration of antibiotics (amoxicillin and metronidazole']","['Tf),  Treponema denticola  (Td', 'saliva samples', 'semiquantitative analysis of red complex microorganisms [ Porphyromonas gingivalis  (Pg),  Tannerella forsythia  ', 'quantities of Tf and Td in subgingival plaque', 'median quantity', 'median quantity of Pg', 'plaque index (PLI), probing depth (PD) and bleeding index (BI', 'quantities of Pg, Tf and Td in subgingival plaque samples', 'quantities of Tf and Td in saliva']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0447318', 'cui_str': 'Mesial-buccal'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}]","[{'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}]","[{'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",23.0,0.0337855,"Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars.","[{'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Feng', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Lu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Z B', 'Initials': 'ZB', 'LastName': 'Chen', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Meng', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.cn112144-20200325-00171']
2244,32635181,Impact of Glutathione and Vitamin B-6 in Cirrhosis Patients: A Randomized Controlled Trial and Follow-Up Study.,"Vitamin B-6 and glutathione (GSH) are antioxidant nutrients, and inadequate vitamin B-6 may indirectly limit glutathione synthesis and further affect the antioxidant capacities. Since liver cirrhosis is often associated with increased oxidative stress and decreased antioxidant capacities, we conducted a double-blind randomized controlled trial to assess the antioxidative effect of vitamin B-6, GSH, or vitamin B-6/GSH combined supplementation in cirrhotic patients. We followed patients after the end of supplementation to evaluate the association of vitamin B-6 and GSH with disease severity. In total, 61 liver cirrhosis patients were randomly assigned to placebo, vitamin B-6 (50 mg pyridoxine/d), GSH (500 mg/d), or B-6 + GSH groups for 12 weeks. After the end of supplementation, the condition of patient's disease severity was followed until the end of the study. Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities. The median follow-up time was 984 d, and 21 patients were lost to follow-up. High levels of GSH, a high GSH/oxidized GSH ratio, and high GSH-St activity at baseline (Week 0) had a significant effect on low Child-Turcotte-Pugh scores at Week 0, the end of supplementation (Week 12), and the end of follow-up in all patients after adjusting for potential confounders. Although the decreased GSH and its related enzyme activity were associated with the severity of liver cirrhosis, vitamin B-6 and GSH supplementation had no significant effect on reducing oxidative stress and increasing antioxidant capacities.",2020,Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities.,"['Cirrhosis Patients', '61 liver cirrhosis patients', 'cirrhotic patients']","['Vitamin B-6 and glutathione (GSH', 'vitamin B-6, GSH, or vitamin B-6/GSH combined supplementation', 'Glutathione and Vitamin B-6', 'B-6 + GSH', 'placebo, vitamin B-6 (50 mg pyridoxine/d), GSH', 'vitamin B-6 nor GSH supplementation']","['low Child-Turcotte-Pugh scores', 'oxidative stress and antioxidant capacities', 'High levels of GSH, a high GSH/oxidized GSH ratio, and high GSH-St activity', 'oxidative stress and increasing antioxidant capacities']","[{'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}]","[{'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0626128', 'cui_str': ""5'-O-(6-O-malonylglucopyranosyl)pyridoxine""}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3854424', 'cui_str': 'Child-Pugh-Turcotte score'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",61.0,0.342681,Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities.,"[{'ForeName': 'Chia-Yu', 'Initials': 'CY', 'LastName': 'Lai', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Shao-Bin', 'Initials': 'SB', 'LastName': 'Cheng', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Teng-Yu', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Yung-Fang', 'Initials': 'YF', 'LastName': 'Hsiao', 'Affiliation': 'Graduate Program in Nutrition, Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Hsiao-Tien', 'Initials': 'HT', 'LastName': 'Liu', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}]",Nutrients,['10.3390/nu12071978']
2245,32635281,"Influence of an Aquatic Therapy Program on Perceived Pain, Stress, and Quality of Life in Chronic Stroke Patients: A Randomized Trial.","Pain and depressive states may have a negative impact on the quality of life of individuals with stroke. The aim of this study was to evaluate the effects of a program of Ai Chi aquatic therapy on pain, depression, and quality of life in a sample of people with stroke. Forty-five participants received physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy. The Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale were used as outcome measures. Statistically significant differences were found in the experimental group and the combined intervention group for post treatment pain and resilience ( p  < 0.001). Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001). In conclusion, physical exercise performed in water has positive effects on several factors that contribute towards improving the mood and quality of life of people with acquired brain injury.",2020,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","['Chronic Stroke Patients', 'people with stroke']","['Aquatic Therapy Program', 'physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy', 'Ai Chi aquatic therapy', 'physical exercise']","['general health, vitality, and social function', 'Perceived Pain, Stress, and Quality of Life', 'Pain and depressive states', 'mood and quality of life', 'Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale', 'pain, depression, and quality of life']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",45.0,0.0453378,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, La Cañada de San Urbano, 04120 Almería, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134796']
2246,32635288,The Influence of Proprioceptive Training with the Use of Virtual Reality on Postural Stability of Workers Working at Height.,"The aim of the study was to assess the impact of proprioceptive training with the use of virtual reality (VR) on the level of postural stability of high-altitude workers. Twenty-one men working at height were randomly assigned to the experimental group (EG) with training ( n  = 10) and control group (CG) without training ( n  = 11). Path length of the displacement of the center of pressure (COP) signal and its components in the anteroposterior and medial-lateral directions were measured with use of an AccuGaitTM force plate before and after intervention (6 weeks, 2 sessions × 30 min a week). Tests were performed at two different platform heights, with or without eyes open and with or without a dual task. Two-way ANOVA revealed statistically significant interaction effects for low-high threat, eyes open-eyes closed, and single task-dual task. Post-training values of average COP length were significantly lower in the EG than before training for all analyzed parameters. Based on these results, it can be concluded that the use of proprioceptive training with use of VR can support, or even replace, traditional methods of balance training.",2020,Post-training values of average COP length were significantly lower in the EG than before training for all analyzed parameters.,"['high-altitude workers', 'Twenty-one men working at height', 'Workers Working at Height']","['Proprioceptive Training', 'proprioceptive training', 'virtual reality (VR', 'control group (CG) without training']","['average COP length', 'Path length of the displacement of the center of pressure (COP) signal']","[{'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",21.0,0.012365,Post-training values of average COP length were significantly lower in the EG than before training for all analyzed parameters.,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cyma-Wejchenig', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Tarnas', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Marciniak', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stemplewski', 'Affiliation': 'Poznan University of Physical Education, 61-871 Poznan, Poland.'}]","Sensors (Basel, Switzerland)",['10.3390/s20133731']
2247,32635352,Everyday Pedelec Use and Its Effect on Meeting Physical Activity Guidelines.,"Pedelecs (e-bikes with electrical support up to 25 km·h -1 ) are important in active transportation. Yet, little is known about physiological responses during their everyday use. We compared daily pedelec (P) and bicycle (B) use to determine if pedelecs are a suitable tool to enhance physical activity. In 101 employees, cycling duration and intensity, heart rate (HR) during P and B were recorded via a smartphone app. Each recording period was a randomized crossover design and lasted two weeks. The ride quantity was higher in P compared to B (5.3 ± 4.3 vs. 3.2 ± 4.0 rides·wk -1 ;  p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ± 109 min·wk -1 ;  p  < 0.001). The mean HR during P was lower than B (109 ± 14 vs. 118 ± 17 bpm;  p  < 0.001). The perceived exertion was lower in P (11.7 ± 1.8 vs. 12.8 ± 2.1 in B;  p  < 0.001). The weekly energy expenditure was higher during P than B (717 ± 652 vs. 486 ± 557 metabolic equivalents of the task [MET]·min·wk -1 ;  p  < 0.01). Due to a sufficient HR increase in P, pedelecs offer a more active form of transportation to enhance physical activity.",2020,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,[],[],"['total cycling time', 'weekly energy expenditure', 'ride quantity', 'perceived exertion', 'cycling duration and intensity, heart rate (HR', 'mean HR during P']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0676234,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,"[{'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Boyen', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Finkel', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17134807']
2248,32635503,"Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study.","The risk of cardiovascular diseases and type 2 diabetes mellitus are increased in subjects with metabolic syndrome (MetS), and hydrolyzed fish protein may have favorable effects on metabolic health. Here, we investigated the effect of 8 weeks supplementation with 4 g of cod protein hydrolysate (CPH) on glucose metabolism, lipid profile and body composition in individuals with MetS in a double-blind, randomized intervention study with a parallel-group design. Subjects received a daily supplement of CPH ( n  = 15) or placebo ( n  = 15). Primary outcomes were serum fasting and postprandial glucose levels. Secondary outcomes were fasting and postprandial insulin and glucagon-like peptide 1 (GLP-1), fasting lipid concentrations and body composition. No difference was observed between CPH and placebo for insulin, glucose or GLP-1 after 8 weeks intervention. Fasting triacylglycerol decreased in both the CPH group and placebo group, with no change between groups. Fasting total cholesterol and low-density lipoprotein cholesterol decreased significantly within both groups from baseline to study end, but no difference was observed between the two groups. In conclusion, supplementing with a low dose of CPH in subjects with MetS for 8 weeks had no effect on fasting or postprandial levels of insulin, glucose or GLP-1, lipid profile or body composition.",2020,"Fasting total cholesterol and low-density lipoprotein cholesterol decreased significantly within both groups from baseline to study end, but no difference was observed between the two groups.","['Adults with Metabolic Syndrome', 'subjects with metabolic syndrome (MetS', 'individuals with MetS']","['daily supplement of CPH', 'Cod Protein Hydrolysate', 'CPH and placebo', 'CPH', 'cod protein hydrolysate (CPH', 'placebo']","['insulin, glucose or GLP-1', 'Fasting triacylglycerol', 'Fasting total cholesterol and low-density lipoprotein cholesterol', 'fasting or postprandial levels of insulin, glucose or GLP-1, lipid profile or body composition', 'glucose metabolism, lipid profile and body composition', 'Glucose Regulation and Lipid Metabolism', 'fasting and postprandial insulin and glucagon-like peptide 1 (GLP-1), fasting lipid concentrations and body composition', 'serum fasting and postprandial glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",,0.426719,"Fasting total cholesterol and low-density lipoprotein cholesterol decreased significantly within both groups from baseline to study end, but no difference was observed between the two groups.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Fjeldheim Dale', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Brønstad', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Gülen Arslan', 'Initials': 'GA', 'LastName': 'Lied', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Dag Arne Lihaug', 'Initials': 'DAL', 'LastName': 'Hoff', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Ålesund Hospital, Møre and Romsdal Hospital Trust, 6026 Ålesund, Norway.'}]",Nutrients,['10.3390/nu12071991']
2249,32635585,Effect of Non-Surgical Periodontal Treatment on Oxidative Stress Markers in Leukocytes and Their Interaction with the Endothelium in Obese Subjects with Periodontitis: A Pilot Study.,"AIM


The primary objective of this pilot study was to evaluate the effect of non-surgical periodontal treatment. The secondary aim was to evaluate the effect of dietary therapy on both parameters of oxidative stress in leukocytes and leukocyte-endothelial cell interactions in an obese population.
METHODS


This was a pilot study with a before-and-after design. Forty-nine obese subjects with periodontitis were randomized by means of the minimization method and assigned to one of two groups, one of which underwent dietary therapy while the other did not. All the subjects underwent non-surgical periodontal treatment. We determined periodontal, inflammatory and oxidative stress parameters-total reactive oxygen species (ROS), superoxide production, intracellular Ca 2+ , mitochondrial membrane potential and superoxide dismutase (SOD) activity. We also evaluated interactions between leukocytes and endothelium cells-velocity, rolling flux and adhesion-at baseline and 12 weeks after intervention.
RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes. In the patients undergoing dietary therapy, there were less leukocyte adhesion to the endothelium, an effect that was accompanied by a decrease in TNFα, P-selectin and total ROS and an increase in SOD activity.
CONCLUSIONS


Whereas non-surgical periodontal treatment induces an improvement in leukocyte homeostasis, dietary therapy as an adjuvant reduces systemic inflammation and increases antioxidant status which, in turn, modulates leukocyte-endothelium dynamics.",2020,"RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes.","['obese population', 'Obese Subjects with Periodontitis', 'Forty-nine obese subjects with periodontitis']","['Surgical Periodontal Treatment', 'dietary therapy']","['periodontal, inflammatory and oxidative stress parameters-total reactive oxygen species (ROS), superoxide production, intracellular Ca 2+ , mitochondrial membrane potential and superoxide dismutase (SOD) activity', 'TNFα, P-selectin and total ROS', 'SOD activity', 'leukocytes and endothelium cells-velocity, rolling flux and adhesion', 'serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes', 'periodontal health', 'leukocyte adhesion', 'leukocyte homeostasis']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C1383501', 'cui_str': 'Cytoplasmic matrix'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}]",49.0,0.0293666,"RESULTS


Periodontal treatment improved the periodontal health of all the patients, with a reduction in serum retinol-binding protein 4 (RBP4), total superoxide production and cytosolic Ca 2+  in leukocytes.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Martínez-Herrera', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Zaida', 'Initials': 'Z', 'LastName': 'Abad-Jiménez', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Silvestre', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'López-Domènech', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Cecilia Fabiana', 'Initials': 'CF', 'LastName': 'Márquez-Arrico', 'Affiliation': 'Department of Stomatology, University of Valencia, Gascó i Oliag 1, 46010 Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Silvestre-Rangil', 'Affiliation': 'Department of Stomatology, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Víctor', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'Department of Endocrinology and Nutrition, University Hospital Doctor Peset-FISABIO, Av. Gaspar Aguilar 90, 46017 Valencia, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9072117']
2250,32635650,Mind over Matter: Testing the Efficacy of an Online Randomized Controlled Trial to Reduce Distraction from Smartphone Use.,"Evidence suggests a growing call for the prevention of excessive smartphone and social media use and the ensuing distraction that arises affecting academic achievement and productivity. A ten-day online randomized controlled trial with the use of smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking, was implemented amongst UK university students ( n  = 143). Participants were asked to complete online pre- and post-intervention assessments. Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes. The intervention was not effective in reducing habitual behaviours, nomophobia, or time spent on social media. Mediation analyses demonstrated that: (i) emotional self-awareness but not mindful attention mediated the relationship between intervention effects and smartphone distraction, and (ii) online vigilance mediated the relationship between smartphone distraction and problematic social media use. The present study provides preliminary evidence of the efficacy of an intervention for decreased smartphone distraction and highlights psychological processes involved in this emergent phenomenon in the smartphone literature. Online interventions may serve as complementary strategies to reduce distraction levels and promote insight into online engagement. More research is required to elucidate the mechanisms of digital distraction and assess its implications in problematic use.",2020,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,['UK university students ( n  = 143'],"['smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking', 'Mind over Matter']","['smartphone distraction and improvement scores', 'habitual behaviours, nomophobia, or time spent on social media']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]",,0.0449527,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,"[{'ForeName': 'Melina A', 'Initials': 'MA', 'LastName': 'Throuvala', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Rennoldson', 'Affiliation': 'Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Daria J', 'Initials': 'DJ', 'LastName': 'Kuss', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17134842']
2251,32635661,"The Effectiveness of Synbiotic Preparation Containing  Lactobacillus  and  Bifidobacterium  Probiotic Strains and Short Chain Fructooligosaccharides in Patients with Diarrhea Predominant Irritable Bowel Syndrome-A Randomized Double-Blind, Placebo-Controlled Study.","The purpose of the randomized double-blind placebo-controlled trial was to assess the effectiveness of synbiotic preparation containing probiotic  Lactobacillus rhamnosus  FloraActive™ 19070-2,  Lactobacillus acidophilus  DSMZ 32418,  Bifidobacterium lactis  DSMZ 32269,  Bifidobacterium longum  DSMZ 32946,  Bifidobacterium bifidum  DSMZ 32403 and fructooligosaccharides in adult patients with diarrhea-dominant IBS (IBS-D). The study included eighty patients with moderate and severe IBS-D who were randomized to receive synbiotics or placebo for eight weeks. Finally, a total of sixty-eight patients finished the study. The primary endpoints included the assessment of the symptoms' severity with IBS symptom severity scale (IBS-SSS), an improvement of IBS global symptoms with Global Improvement Scale (IBS-GIS) and adequate relief of symptoms after four and eight weeks of therapy. Secondary endpoints, which were collected by telephone interviewers three times a week included the assessment of individual IBS symptoms and adverse events. Synbiotic treatment in comparison to placebo significantly improved IBS-GIS ( p  = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS ( p  = 0.042) and in domain-specific scores related to flatulence ( p  = 0.028) and bowel habit ( p  = 0.028) after four and eight weeks. Patients treated with synbiotics reported in weekly observations a significant amelioration in a feeling of incomplete bowel movements, flatulence, pain, stool pressure and diarrheal stools compared to those receiving placebo. There were no differences in adverse events between both groups. Concluding, the multi-strain synbiotic preparation was associated with a significant improvement in symptoms in IBS-D patients and was well-tolerated. These results suggest that the use of synbiotics offers a benefit for IBS-D patients. [Clinicaltrials.gov NCT04206410 registered 20 December 2019].",2020,"Synbiotic treatment in comparison to placebo significantly improved IBS-GIS ( p  = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS ( p  = 0.042) and in domain-specific scores related to flatulence ( p  = 0.028) and bowel habit ( p  = 0.028) after four and eight weeks.","['Patients with Diarrhea Predominant Irritable Bowel Syndrome', 'eighty patients with moderate and severe IBS-D', 'adult patients with diarrhea-dominant IBS (IBS-D']","['synbiotics or placebo', 'Synbiotic Preparation Containing  Lactobacillus  and  Bifidobacterium  Probiotic Strains and Short Chain Fructooligosaccharides', 'Placebo', 'placebo']","['feeling of incomplete bowel movements, flatulence, pain, stool pressure and diarrheal stools', 'IBS-SSS score', 'bowel habit', ""assessment of the symptoms' severity with IBS symptom severity scale (IBS-SSS), an improvement of IBS global symptoms with Global Improvement Scale (IBS-GIS) and adequate relief of symptoms"", 'adverse events', 'total IBS-SSS', 'individual IBS symptoms and adverse events', 'IBS-GIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",80.0,0.390541,"Synbiotic treatment in comparison to placebo significantly improved IBS-GIS ( p  = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS ( p  = 0.042) and in domain-specific scores related to flatulence ( p  = 0.028) and bowel habit ( p  = 0.028) after four and eight weeks.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Skrzydło-Radomańska', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Prozorow-Król', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Cichoż-Lach', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Majsiak', 'Affiliation': 'Faculty of Medicine, Cardinal Stefan Wyszynski University, Wóycickiego 1/3, 01-938 Warszaw, Poland.'}, {'ForeName': 'Joanna B', 'Initials': 'JB', 'LastName': 'Bierła', 'Affiliation': 'Department of Pathology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kosikowski', 'Affiliation': 'Out-Patient Clinic, Konopnica 96L, 21-030 Motycz, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Szczerbiński', 'Affiliation': 'Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Gantzel', 'Affiliation': 'Biocare Copenhagen, Ole Maaloes Vej 3, DK-2200 Copenhagen, Denmark.'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Cukrowska', 'Affiliation': 'Department of Pathology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland.'}]",Nutrients,['10.3390/nu12071999']
2252,32635784,Effect of warm environment on the skin blood flow response to food intake.,"BACKGROUND AND OBJECTIVE


Warm exposure places high demands on thermoregulation mechanisms, which depend on the effectiveness of the microvascular function. The associations between the microcirculation and metabolism in warm environments have received little attention. The purpose of this study was to explore skin blood flow (SkBF) in response to food intake in a warm environment compared to control.
METHODS


Thirty-two healthy, acclimated-to-warm-environment and physically active participants were recruited (20 females and 12 males). They participated in two sessions (warm environment: 31 °C and control: 20 °C, presented in randomized order). SkBF was measured before and after standardized food intake through the acquisition of perfusion signals by laser Doppler flowmetry (Periflux System 5000), following a local heating protocol.
RESULTS


SkBF was affected by the environmental temperature, showing an increase in the warm environment compared to control (all  p  < .001). SkBF was significantly affected by food intake (all  p  < .007), being reduced after meals. In the men's group, SkBF was reduced in both environmental temperatures after meals. In women, meals affected SkBF at 20 °C but not in the warm environment.
CONCLUSION


These results may indicate a competition between thermo- and glyco-regulation in a warm environment to the detriment of glucose homeostasis in women.",2020,"RESULTS


SkBF was affected by the environmental temperature, showing an increase in the warm environment compared to control (all  p  < .001).","['Thirty-two healthy, acclimated-to-warm-environment and physically active participants were recruited (20 females and 12 males', 'women']",[],"['skin blood flow response', 'skin blood flow (SkBF', 'SkBF']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0563030', 'cui_str': 'Warm environment'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",32.0,0.0342166,"RESULTS


SkBF was affected by the environmental temperature, showing an increase in the warm environment compared to control (all  p  < .001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reminy', 'Affiliation': 'Laboratoire ACTES (Adaptation Climat Tropical Exercice Santé, EA3596), Université des Antilles, Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hue', 'Affiliation': 'Laboratoire ACTES (Adaptation Climat Tropical Exercice Santé, EA3596), Université des Antilles, Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Antoine-Jonville', 'Affiliation': 'Laboratoire ACTES (Adaptation Climat Tropical Exercice Santé, EA3596), Université des Antilles, Pointe-à-Pitre, Guadeloupe, France.'}]","International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group",['10.1080/02656736.2020.1788174']
2253,32635883,Preconditioning Effect of Remifentanil Versus Fentanyl in Prevalence of Early Graft Dysfunction in Patients After Liver Transplant: A Randomized Clinical Trial.,"OBJECTIVES


One of the most prevalent complications of orthotopic liver transplant is primary graft dysfunction. Recent studies have shown the preconditioning effect of remifentanil on animal livers but not human livers. Here, we compared the preconditioning effects of remifentanil and fentanyl in orthotopic liver transplant in human patients.
MATERIALS AND METHODS


In this double-blind clinical trial, 100 patients who underwent liver transplant from deceased donors were randomly allocated into 2 groups. Patients in the remifentanil group received remifentanil infusion, and those in the fentanyl group received fentanyl infusion during maintenance of anesthesia. Serum aminotransferase levels, prothrombin time (international normalized ratio), partial thrombin time, arterial blood gas levels, and renal function tests were evaluated over 7 days posttransplant. Intensive care unit stay and hospitalization were also recorded.
RESULTS


The median peak alanine aminotransferase level during 7 days after transplant was 2100 U/L (interquartile range, 1230-3220) in the remifentanil group and 3815 U/L (interquartile range, 2385-5675) in the fentanyl group (P = .048). Metabolic acidosis, renal state, prothrombin time (international normalized ratio), and partial thrombin time were similar in both groups (P > .05). Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively). Overall, the clinical outcomes were similar in the remifentanil and fentanyl groups (P > .05).
CONCLUSIONS


We found that remifentanil and fentanyl were not different with regard to their preconditioning effects and graft protection in orthotopic liver transplant recipients.",2020,"Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively).","['100 patients who underwent liver transplant from deceased donors', 'Patients', 'After Liver Transplant', 'orthotopic liver transplant in human patients', 'orthotopic liver transplant recipients']","['Remifentanil Versus Fentanyl', 'remifentanil infusion', 'fentanyl infusion', 'remifentanil', 'remifentanil and fentanyl']","['Metabolic acidosis, renal state, prothrombin time (international normalized ratio), and partial thrombin time', 'median peak alanine aminotransferase level', 'Intensive care unit stay and hospitalization', 'Durations of stay in the intensive care unit and hospital', 'Serum aminotransferase levels, prothrombin time (international normalized ratio), partial thrombin time, arterial blood gas levels, and renal function tests', 'Prevalence of Early Graft Dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}]",100.0,0.0598673,"Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively).","[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Jowkar', 'Affiliation': 'From the Department of Anesthesia, Nemazee Hospital, Shiraz, Fars, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Khosravi', 'Affiliation': ''}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sahmeddini', 'Affiliation': ''}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Eghbal', 'Affiliation': ''}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Samadi', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2019.0014']
2254,32635933,Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol.,"BACKGROUND


In the Netherlands, midwives are required to use the 'V-MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol is often poorly implemented in midwifery practices. It may also be less suitable for pregnant woman with low socioeconomic status or functional health illiteracy. We created an adapted version of the V-MIS protocol that is intended to facilitate implementation in midwifery practices: PROMISE (PROtocol for growing up smokefree using a Minimal smoking cessation Intervention Strategy in the Early stages of life). For this adapted protocol, midwives use carbon monoxide meters, storyboard leaflets, and specific communication techniques for women with functional health illiteracy. They will receive a face-to-face training in using these materials and communication techniques.
METHODS


The effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will then train them, subsequently, at regular intervals ('steps'). At each step, practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. Among them, we will assess smoking status and health-related outcome before and after pregnancy.
DISCUSSION


The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
TRIAL REGISTRATION


Dutch Trial Registry: NTR 6305/NL6158 . Registered on 20 December 2016.",2020,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
","['midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE', 'pregnant women with functional health illiteracy and low socioeconomic status', 'pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome', 'women with functional health illiteracy', 'pregnant women with smoking cessation', 'pregnant woman with low socioeconomic status or functional health illiteracy', 'midwifery practices and departments in hospitals']","[""MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol"", 'smoking cessation counselling training programme']",[],"[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.125279,"The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.
","[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bommelé', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands. jbommele@trimbos.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Springvloet', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Naïma', 'Initials': 'N', 'LastName': 'Abouri', 'Affiliation': 'Pharos, Utrecht, the Netherlands.'}, {'ForeName': 'Karianne', 'Initials': 'K', 'LastName': 'Djoyoadhiningrat-Hol', 'Affiliation': 'Lung Foundation Netherlands, Amersfoort, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'van Laar', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}]",Trials,['10.1186/s13063-020-04555-0']
2255,32635999,Long-term use of minimal footwear in older adult women with knee osteoarthritis: Mechanisms of action in the knee adduction moment.,"Studies have shown the short- and long-term effects of wearing minimalist footwear in reducing knee loads in patients with knee osteoarthritis (OA). This study aimed to investigate the mechanisms underpinning the reduction in external knee adduction moment (EKAM) in older adult women who wore this type of footwear through a randomized controlled trial. Fifty-six participants with medial compartment knee OA were equally allocated to either an intervention group (IG) that wore minimalist footwear (Moleca®) or to a control group (CG) that continued regular clinical treatment for OA for six months. The influence of lower limb joint kinematics and joint frontal moments, center of pressure displacement, and foot progression angle in predicting the reduction of EKAM were assessed after a six-month intervention. Surprisingly, none of the seven independent variables predicted the first peak EKAM in the multiple regression model for the IG. For the CG, the increase of one unit in the first peak of the hip adduction moment resulted in a 1.01 units increase in the first peak EKAM. Additionally, a one-unit reduction in the ankle eversion angle resulted in an increase of 0.16 units in the percent change in the first peak EKAM. Thus, wearing the Moleca® shoe for six months helped the participants keep a natural gait pattern without increasing the hip moment or the ankle inversion angle compared to the women who did not wear the Moleca® footwear. ClinicalTrials.gov (NCT01342458).",2020,This study aimed to investigate the mechanisms underpinning the reduction in external knee adduction moment (EKAM) in older adult women who wore this type of footwear through a randomized controlled trial.,"['patients with knee osteoarthritis (OA', 'older adult women with knee osteoarthritis', 'Fifty-six participants with medial compartment knee OA', 'older adult women who wore this type of footwear through a randomized controlled trial']","['external knee adduction moment (EKAM', 'intervention group (IG) that wore minimalist footwear (Moleca®) or to a control group (CG) that continued regular clinical treatment for OA for six months']","['lower limb joint kinematics and joint frontal moments, center of pressure displacement, and foot progression angle', 'knee loads']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",56.0,0.0290131,This study aimed to investigate the mechanisms underpinning the reduction in external knee adduction moment (EKAM) in older adult women who wore this type of footwear through a randomized controlled trial.,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Trombini-Souza', 'Affiliation': 'Physical Therapy Dept., University of Pernambuco, PE, Brazil. Electronic address: francis.trombini@upe.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Goldenstein-Schainberg', 'Affiliation': 'Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo, Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional, SP, Brazil.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.109885']
2256,32636011,Carbon dioxide hydrate as a recovery tool after fatigue of the plantar flexors.,"This study investigated the effects of cooling the triceps surae with carbon dioxide hydrate (CDH), which is a gas hydrate, a crystalline structure belonging to the clathrates, on the recovery from muscle fatigue. Thirty-six healthy young men were equally and randomly assigned to an ICE group, a CDH group, or a non-cooling (NON) group. All participants performed 80 maximal voluntary isometric contractions (MVCs) of the plantar flexors as a fatiguing task. MVC torque and voluntary activation were determined before, immediately after, and 20 min after the fatiguing task. Evoked torque was similarly assessed except for immediately after the task. In the ICE and CDH groups, the triceps surae was cooled for 5 min using ice and CDH, starting 5 min after the fatiguing task, respectively. The MVC torque and voluntary activation were higher in order of before >20 min after >immediately after the fatiguing task regardless of group, and those time-course changes did not differ between the groups. A decrease in the evoked torque from before to 20 min after the fatiguing task was observed in the ICE and NON groups but not in the CDH group. These results suggest that cooling muscle with CDH can facilitate recovery from peripheral muscle fatigue. This may be due to an increase in blood flow caused by carbon dioxide contained within the CDH, and indicates the potential of CDH as a recovery tool after fatiguing exercise.",2020,"The MVC torque and voluntary activation were higher in order of before >20 min after >immediately after the fatiguing task regardless of group, and those time-course changes did not differ between the groups.",['Thirty-six healthy young men'],"['carbon dioxide hydrate (CDH', 'CDH', '80 maximal voluntary isometric contractions (MVCs) of the plantar flexors as a fatiguing task', 'ICE', 'CDH group, or a non-cooling (NON', 'Carbon dioxide hydrate']","['Evoked torque', 'evoked torque', 'blood flow', 'MVC torque and voluntary activation']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",80.0,0.0167842,"The MVC torque and voluntary activation were higher in order of before >20 min after >immediately after the fatiguing task regardless of group, and those time-course changes did not differ between the groups.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan; Research Fellow of Japan Society for the Promotion of Science, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanimoto', 'Affiliation': 'Graduate School of Health Management, Keio University, Kanagawa, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Hirata', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Imaizumi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Sugihara', 'Affiliation': 'Research Laboratories for Beverage Technologies, Kirin Holdings Company, Limited, Kanagawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Research Laboratories for Beverage Technologies, Kirin Holdings Company, Limited, Kanagawa, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'Graduate School of Engineering and Science, Shibaura Institute of Technology, Saitama, Japan; College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan. Electronic address: rakagi12@shibaura-it.ac.jp.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.109900']
2257,32636205,Efficacy of reminders for increasing volunteer engagement in translating Cochrane plain language summaries: a pilot randomised controlled trial.,"OBJECTIVES


The aim of this study was to pilot test the effectiveness of reminders versus no intervention for increasing the number of translated Cochrane plain language summaries (PLSs) among volunteer translators.
STUDY DESIGN


Parallel-group randomised controlled trial.
SETTING


Cochrane Croatia translation project.
PARTICIPANTS


Adults who volunteered to translate Cochrane PLSs within the Cochrane Croatia translation project.
INTERVENTION


The participants were randomly allocated to intervention (receiving up to four bi-weekly email reminders to translate PLSs) or control group (no intervention).
PRIMARY OUTCOME


The number of translated PLSs within the 6-month trial period.
RESULTS


We included 80 participants. The median number of translated PLSs after 6 months was 9 in the intervention group (95% CI 2.0 to 15.0) and 4 in the control group (95% CI 2.9 to 7.0), but this was not significantly different (p=0.181, Mann-Whitney U test). There was no difference between the groups in the number of translations after 3 months, the average time-to-translation after 3 or 6 months, or the satisfaction at the end of the study period. The number of reminders received and the number of translated summaries were negatively correlated (r=-0.50; 95% CI -0.70 to -0.22).
CONCLUSIONS


Our pilot trial showed that reminders do not seem to be significantly effective in increasing the number of PLS translations. Future studies could explore whether different frequency, timing and content of reminders have an influence on an increase in the engagement among volunteer translators of evidence synthesis.
TRIAL REGISTRATION


NCT03534791.",2020,"There was no difference between the groups in the number of translations after 3 months, the average time-to-translation after 3 or 6 months, or the satisfaction at the end of the study period.","['Adults who volunteered to translate Cochrane PLSs within the Cochrane Croatia translation project', '80 participants', 'translating Cochrane plain language summaries', 'volunteer translators']","['intervention (receiving up to four bi-weekly email reminders to translate PLSs) or control group (no intervention', 'reminders versus no intervention']","['average time-to-translation', 'median number of translated PLSs', 'number of PLS translations', 'number of reminders received and the number of translated summaries']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0040713', 'cui_str': 'Translator'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}]",80.0,0.182076,"There was no difference between the groups in the number of translations after 3 months, the average time-to-translation after 3 or 6 months, or the satisfaction at the end of the study period.","[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Jakus', 'Affiliation': 'Institute for Emergency Medicine of Split-Dalmatia County, Split, Croatia.'}, {'ForeName': 'Dalibora', 'Initials': 'D', 'LastName': 'Behmen', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Buljan', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Marušić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Croatian Catholic University, Zagreb, Croatia livia.puljak@unicath.hr livia.puljak@gmail.com.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111378']
2258,32636279,Effects of 0 PEEP and < 1.0 F IO 2  on S pO 2  and P ETCO 2  During Open Endotracheal Suctioning.,"BACKGROUND


Hyperoxygenation and hyperinflation, preferably with a mechanical ventilator, is the most commonly used technique to prevent the adverse effects of open endotracheal suctioning on arterial oxygenation and pulmonary volume. However, limited data are available on the effects of oxygen concentrations < 100% and PEEP with zero end-expiratory pressure (0 PEEP) to improve oxygenation and to maintain adequate ventilation during open endotracheal suctioning. The aim of this study was to analyze the behavior of S pO 2  and end-tidal CO 2  pressure (P ETCO 2  ) in open endotracheal suctioning using the 0 PEEP technique with baseline F IO 2  (0 PEEP baseline F IO 2  ) and 0 PEEP + hyperoxygenation of 20% above the baseline value (0 PEEP F IO 2  + 0.20) in critically ill subjects receiving mechanical ventilation.
METHODS


This was a prospective, randomized, single-blind crossover study, for which 48 subjects with various clinical and surgical conditions were selected; of these, 38 subjects completed the study. The subjects were randomized for 2 interventions: 0 PEEP baseline F IO 2  and 0 PEEP F IO 2  + 0.20 during the open endotracheal suctioning procedure. Oxygenation was assessed via oxygen saturation as measured with pulse oximetry (S pO 2  ), and changes in lung were monitored via P ETCO 2  using volumetric capnography.
RESULTS


In the intragroup analysis with 0 PEEP baseline F IO 2  , there was no significant increase after open endotracheal suctioning in either S pO 2  ( P  = .63) or P ETCO 2  ( P  = .11). With 0 PEEP F IO 2  + 0.20, there was a significant increase in S pO 2  ( P  < .001), with no significant changes in P ETCO 2  ( P  = .55). In the intergroup comparisons, there was a significant increase compared to the basal values only with the 0 PEEP + 0.20 method at 1 min after hyperoxygenation ( P  < .001), post-immediately ( P  < .001), at 1 min after ( P  < .001), and at 2 min after open endotracheal suctioning ( P  < .001).
CONCLUSIONS


The appropriate indication of the hyperinflation strategy via mechanical ventilation using 0 PEEP with or without hyperoxygenation proved to be efficient to maintain S pO 2  and P ETCO 2  levels. These results suggest that the technique can minimize the loss of lung volume due to open endotracheal suctioning.",2020,", there was a significant increase in S pO 2  ( P  < .001), with no significant changes in P ETCO 2  ( P  = .55).","['48 subjects with various clinical and surgical conditions were selected; of these, 38 subjects completed the study', 'open endotracheal suctioning using the 0 PEEP technique with baseline F IO 2  ']",['PEEP F IO 2  + 0.20'],"['PEEP baseline F IO 2', 'S pO 2', 'basal values', 'loss of lung volume', 'via oxygen saturation as measured with pulse oximetry (S pO 2  ), and changes in lung']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",48.0,0.0440365,", there was a significant increase in S pO 2  ( P  < .001), with no significant changes in P ETCO 2  ( P  = .55).","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Rodrigues de Freitas Vianna', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil. jacrfvianna@uol.com.br.'}, {'ForeName': 'Valéria Amorim', 'Initials': 'VA', 'LastName': 'Pires Di Lorenzo', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Miléa Mara', 'Initials': 'MM', 'LastName': 'Lourenço da S Simões', 'Affiliation': 'Intensive Care Physiotherapy, Santa Casa de Misericórdia Hospital, Batatais, São Paulo, Brazil.'}, {'ForeName': 'Jorge Luís', 'Initials': 'JL', 'LastName': 'Guerra', 'Affiliation': 'Intensive Care Physiotherapy, Santa Casa de Misericórdia Hospital, Batatais, São Paulo, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Jamami', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}]",Respiratory care,['10.4187/respcare.07435']
2259,32636281,"Protocol for a phase IV, open-label feasibility study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT alone.","INTRODUCTION


At least 30% of people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD), which has now become a leading cause of hepatic fibrosis and cirrhosis. Management is based largely on lifestyle modifications, which are difficult to achieve, and therapeutic options are urgently needed. Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD. However, dosing is usually two times per day, unlike most currently recommended antiretroviral therapies. This study will investigate the feasibility and acceptability of addition of MVC to combination antiretroviral therapy in PLWH and NAFLD as a treatment for NAFLD.
METHODS AND ANALYSIS


This is a phase IV, randomised, open-label, non-invasive feasibility study. Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics and randomised 1:1 to receive either optimised background therapy (OBT) plus MVC or OBT alone. Follow-up will be every 24 weeks for 96 weeks. The primary outcome measures will include recruitment and retention rates, adverse events and adherence. Secondary outcomes will include changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments. Analyses will be performed according to intention-to-treat principles. For secondary outcomes, estimated differences and 95% CIs between the groups using a t-method will be presented for continuous variables and as exact 95% binomial CIs for categorical variables.
ETHICS AND DISSEMINATION


Ethical approval was obtained through the London Dulwich UK Research Ethics Committee (reference 17/LO/2093). Results will be disseminated both through community groups and peer-reviewed scientific literature. Trial registration number  SRCTN31461655. EudraCT number 2017-004141-24; Pre-results.",2020,"Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD.","['people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving', 'Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics', 'people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD']","['MVC', 'optimised background therapy (OBT) plus MVC or OBT alone', 'optimised background therapy (OBT) plus maraviroc or OBT alone']","['changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments', 'recruitment and retention rates, adverse events and adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",60.0,0.212247,"Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bradshaw', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton daniel.bradshaw2@nhs.net.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Gilleece', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Iga', 'Initials': 'I', 'LastName': 'Abramowicz', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Perry', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035596']
2260,32636283,Development of an occupational advice intervention for patients undergoing elective hip and knee replacement: a Delphi study.,"OBJECTIVE


To obtain consensus on the content and delivery of an occupational advice intervention for patients undergoing primary hip and knee replacement surgery. The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
DESIGN


Modified Delphi study as part of a wider intervention development study (The Occupational advice for Patients undergoing Arthroplasty of the Lower limb (OPAL) study: Health Technology Assessment Reference 15/28/02) (ISRCTN27426982).
SETTING


Five stakeholder groups (patients, employers, orthopaedic surgeons, general practitioners, allied health professionals and nurses) recruited from across the UK.
PARTICIPANTS


Sixty-six participants.
METHODS


Statements for the Delphi process were developed relating to the content, format, delivery, timing and measurement of an occupational advice intervention. The statements were based on evidence gathered through the OPAL study that was processed using an intervention mapping framework. Intervention content was examined in round 1 and intervention format, delivery, timing and measurement were examined in round 2. In round 3, the developed intervention was presented to the stakeholder groups for comment.
CONSENSUS


For rounds 1 and 2, consensus was defined as 70% agreement or disagreement on a 4-point scale. Statements reaching consensus were ranked according to the distribution of responses to create a hierarchy of agreement. Round 3 comments were used to revise the final version of the developed occupational advice intervention.
RESULTS


Consensus was reached for 36 of 64 round 1 content statements (all agreement). In round 2, 13 questions were carried forward and an additional 81 statements were presented. Of these, 49 reached consensus (44 agreement/5 disagreement). Eleven respondents provided an appraisal of the intervention in round 3.
CONCLUSIONS


The Delphi process informed the development of an occupational advice intervention as part of a wider intervention development study. Stakeholder agreement was achieved for a large number of intervention elements encompassing the content, format, delivery and timing of the intervention. The effectiveness and cost-effectiveness of the developed intervention will require evaluation in a randomised controlled trial.
TRIAL REGISTRATION NUMBER


International Standard Randomised Controlled Trials Number Trial ID: ISRCTN27426982.",2020,"The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
","['patients undergoing primary hip and knee replacement surgery', 'Patients undergoing Arthroplasty of the Lower limb (OPAL) study: Health Technology Assessment Reference 15/28/02', 'Five stakeholder groups (patients, employers, orthopaedic surgeons, general practitioners, allied health professionals and nurses) recruited from across the UK', 'patients undergoing elective hip and knee replacement', 'Sixty-six participants']",['occupational advice intervention'],['effectiveness and cost-effectiveness'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039423', 'cui_str': 'Assessment, Biomedical Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",81.0,0.0562813,"The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK paul.baker1@nhs.net.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Coole', 'Affiliation': 'School of Health Sciences, Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036191']
2261,32641220,Higher unacylated ghrelin and insulin sensitivity following dietary restriction and weight loss in obese humans.,"BACKGROUND & AIMS


Unacylated ghrelin (UnAG) modulates insulin sensitivity. Low plasma UnAG occurs in obesity and potentially contributes to obesity-associated insulin resistance. We hypothesized that improvements in insulin sensitivity in obese people induced by moderate caloric restriction (CR) may be paralleled and at least in part explained by concurrent increases in UnAG levels.
METHODS


20 general community obese people were randomly assigned to 16-week CR (n = 11) or control diet (n = 9). We investigated the impact of CR on the interaction between insulin sensitivity changes [area under the curve (AUCg) of glucose infusion to maintain euglycemia during hyperinsulinemic-euglycemic clamp] and plasma total (TotalG), acylated (AG) and Unacylated ghrelin (UnAG). Plasma pro-inflammatory tumor necrosis factor alpha (TNFα) and anti-inflammatory interleukin-10 (IL-10) were also measured since changes in inflammation may contribute to UnAG activities.
RESULTS


CR reduced BMI and increased insulin sensitivity (p < 0.05). TotalG and UnAG but not AG increased in CR but not in Control (p < 0.05). Il-10 and IL-10/TNFα ratio also increased in CR (p < 0.05). Changes in UnAG were positively associated with changes in AUCg in all subjects (n = 20; p < 0.01) also after adjustment for treatment and changes in BMI and cytokines.
CONCLUSIONS


Caloric restriction modifies circulating ghrelin profile with selective increase in unacylated hormone in obese individuals. The current study supports the hypothesis that higher unacylated ghrelin contributes to improvements in insulin sensitivity following diet-induced weight loss in human obesity.",2020,"Plasma pro-inflammatory tumor necrosis factor alpha (TNFα) and anti-inflammatory interleukin-10 (IL-10) were also measured since changes in inflammation may contribute to UnAG activities.
","['20 general community obese people', 'obese individuals', 'obese humans']","['glucose infusion', 'control diet']","['plasma total (TotalG), acylated (AG) and Unacylated ghrelin (UnAG', 'AUCg', 'Il-10 and IL-10/TNFα ratio', 'Plasma pro-inflammatory tumor necrosis factor alpha (TNFα) and anti-inflammatory interleukin-10 (IL-10', 'BMI and cytokines', 'insulin sensitivity', 'CR reduced BMI and increased insulin sensitivity', 'unacylated hormone']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",20.0,0.0407133,"Plasma pro-inflammatory tumor necrosis factor alpha (TNFα) and anti-inflammatory interleukin-10 (IL-10) were also measured since changes in inflammation may contribute to UnAG activities.
","[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Barazzoni', 'Affiliation': 'Dept. of Medical, Surgical and Health Sciences - University of Trieste, Italy and Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), Trieste, Italy. Electronic address: barazzon@units.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gortan Cappellari', 'Affiliation': 'Dept. of Medical, Surgical and Health Sciences - University of Trieste, Italy and Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), Trieste, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Zanetti', 'Affiliation': 'Dept. of Medical, Surgical and Health Sciences - University of Trieste, Italy and Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), Trieste, Italy.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Klaus', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Semolic', 'Affiliation': 'Dept. of Medical, Surgical and Health Sciences - University of Trieste, Italy and Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), Trieste, Italy.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA. Electronic address: nair@mayo.edu.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.014']
2262,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
2263,32641236,Adherence to postoperative thromboprophylactic medication among gynecologic oncology patients: A subanalysis.,"INTRODUCTION


Venous thromboembolism (VTE) is a major cause of morbidity and mortality among gynecologic cancer patients, especially in the immediate postoperative period. We sought to identify patterns related with patient non-adherence to postoperative prophylactic anticoagulation.
METHODS


Participant data (N = 400) were reviewed from a previously conducted randomized controlled trial comparing the safety and efficacy of prophylactic postoperative anticoagulation with enoxaparin versus apixaban among gynecologic oncology patients. Variables hypothesized to be related to medication adherence were pre-selected by the study authors, and adherence was defined as missing ≤2 days of medication (4 pills or 2 injections) in 28 days postoperatively. For univariate comparisons and multivariate modeling, the threshold for statistical significance was set at p < .05.
RESULTS


Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission. African American race, lower mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission were predictive of non-adherence in a multivariate model. Patients taking enoxaparin versus apixaban more frequently attributed non-adherence to pain or bruising (25.0% vs. 3.1%, P = .01).
CONCLUSION


Our findings provide new insights into factors associated with medication adherence that are particularly relevant to gynecologic oncology patients after surgery. Preoperative interventions to identify patients with these risk factors for more intensive followup of postoperative anticoagulation regimen may help increase medication adherence.",2020,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","['gynecologic cancer patients', 'Participant data (N\xa0=\xa0400', 'gynecologic oncology patients']","['enoxaparin', 'prophylactic postoperative anticoagulation with enoxaparin versus apixaban']","['mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission', 'lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission', 'adherence to pain or bruising', 'medication adherence']","[{'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243164', 'cui_str': 'peroperative procedures'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",400.0,0.05271,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ross', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA. Electronic address: megan.ross@cuanschutz.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Glickman', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.06.505']
2264,32641291,Combining parenting and economic strengthening programmes to reduce violence against children: a cluster randomised controlled trial with predominantly male caregivers in rural Tanzania.,"INTRODUCTION


Parenting programmes may reduce the risk of violence against children and improve child well-being. However, additional economic support may be necessary in highly deprived rural communities in sub-Saharan Africa. Furthermore, delivering programmes within farmer groups may increase male caregiver recruitment and engagement.
METHODS


A parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening programmes on reducing violence against children aged 0-18 years in farming communities in Tanzania (n=248 families; 63% male caregivers). Eight villages were randomly assigned to four conditions (2:2:2:2): (1) 12-session parenting programme (n=60); (2) agribusiness training (n=56); (3) parenting and agribusiness combined (n=72); (4) control (n=60). Parent-report, child-report and early childhood observation assessments were conducted at baseline, mid-treatment and post-treatment. Primary outcomes were child maltreatment and parenting behaviour. Secondary outcomes included corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development.
RESULTS


At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92). Parents reported reduced endorsement of corporal punishment ( D w  =-0.43, 95% CI -0.79 to 0.07) and fewer child behaviour problems ( D w  =-0.41, 95% CI -0.77 to 0.05). Parents in parenting-only villages reported less abuse (IRR=0.36, 95% CI 0.21 to 0.63) and fewer child behaviour problems ( D w  =-0.47, 95% CI -0.84 to 0.11). Parents in agribusiness-only villages reported fewer child behaviour problems ( D w  =-0.43, 95% CI -0.77 to 0.08) and greater household wealth ( D w  =0.57, 95% CI 0.08 to 1.06). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95% CI 1.00 to 5.12) and less positive parenting ( D w  =-0.50, 95% CI -0.91 to 0.10). There were no other adverse effects.
CONCLUSION


Parent training may be the active ingredient in reducing maltreatment in farmer groups with majority male caregivers, while agribusiness training programmes may have unintended negative consequences on children when delivered alone. Locating parenting support in existing farmer groups can engage much higher proportions of fathers than stand-alone programmes.ClinicalTrials.gov: NCT02633319.",2020,"At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92).","['violence against children aged 0-18 years in farming communities in Tanzania (n=248 families; 63% male caregivers', 'Eight villages', 'predominantly male caregivers in rural Tanzania', 'farmer groups with majority male caregivers', 'violence against children']","['agribusiness training (n=56); (3) parenting and agribusiness combined', 'Combining parenting and economic strengthening programmes', 'parenting and economic strengthening programmes', '12-session parenting programme']","['greater household wealth', 'child maltreatment and parenting behaviour', 'incidence rate ratio', 'corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development', 'child behaviour problems', 'positive parenting', 'physical abuse', 'endorsement of corporal punishment', 'adverse effects']","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0474413', 'cui_str': 'Problematic behavior in children'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",8.0,0.282938,"At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92).","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Lachman', 'Affiliation': 'Department of Social Policy and Intervention, University of Oxford, Oxford, UK jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Wamoyi', 'Affiliation': 'National Institute for Medical Research Mwanza Research Centre, Mwanza, Mwanza, United Republic of Tanzania.'}, {'ForeName': 'Thees', 'Initials': 'T', 'LastName': 'Spreckelsen', 'Affiliation': 'School of Social and Political Sciences, University of Glasgow, Glasgow, Glasgow, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wight', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Maganga', 'Affiliation': 'National Institute for Medical Research Mwanza Research Centre, Mwanza, Mwanza, United Republic of Tanzania.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Department of Social Policy and Intervention, University of Oxford, Oxford, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002349']
2265,32641338,"'Only twice a year': a qualitative exploration of 6-month antiretroviral treatment refills in adherence clubs for people living with HIV in Khayelitsha, South Africa.","OBJECTIVE


Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
DESIGN AND SETTING


In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
PARTICIPANTS


Twenty-three patients, seven healthcare workers and six key informants.
RESULTS


Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients' responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
CONCLUSIONS


Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.",2020,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"['Twenty-three patients, seven healthcare workers and six key informants', 'people living with HIV in Khayelitsha, South Africa', 'patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6\u2009months in adherence clubs in Khayelitsha, South Africa', 'In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants']",[],"['unintended disclosure', 'health system efficiency']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],"[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",23.0,0.048509,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"[{'ForeName': 'Claire Marriott', 'Initials': 'CM', 'LastName': 'Keene', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa clairekeene@gmail.com.'}, {'ForeName': 'Nompumelelo', 'Initials': 'N', 'LastName': 'Zokufa', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Emilie C', 'Initials': 'EC', 'LastName': 'Venables', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Wilkinson', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Disease, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cassidy', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Snyman', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grimsrud', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Voget', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'von der Heyden', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Siphokazi', 'Initials': 'S', 'LastName': 'Zide-Ndzungu', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Bhardwaj', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Isaakidis', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}]",BMJ open,['10.1136/bmjopen-2020-037545']
2266,32641337,FitSkills: protocol for a stepped wedge cluster randomised trial of a community-based exercise programme to increase participation among young people with disability.,"INTRODUCTION


There is a need to develop relevant, acceptable initiatives that facilitate physical activity participation in young people with disability.  FitSkills  was developed to support young people with disability to exercise. The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability. The secondary aims are to evaluate cost-effectiveness, changes in attitudes towards disability and other health-related outcomes for young people with disability.
METHODS AND ANALYSIS


A stepped wedge cluster randomised trial using a cohort design and embedded health economic evaluation will compare the effect of  FitSkills  with a control phase.  FitSkills  matches a young person with disability with a student mentor and the pair exercise together at their local gymnasium for 1 hour, two times per week for 12 weeks (24 sessions in total). One hundred and sixty young people with disability aged 13 to 30 years will be recruited. Eight community gymnasia will be recruited and randomised into four cluster units to have  FitSkills  introduced at 3-month intervals. Primary (feasibility, participation and health-related quality of life) and secondary outcomes will be collected longitudinally every 3 months from trial commencement, with eight data collection time points in total. The Practical Robust Implementation and Sustainability Model will be used to support knowledge translation and implementation of project findings into policy and practice.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the La Trobe University Human Ethics Committee (HEC17-012), Australian Catholic University (2017-63R), Deakin University (2017-206) and the Victorian Department of Education and Training (2018_003616). Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups.
TRIAL REGISTRATION NUMBER


ACTRN12617000766314.
TRIAL SPONSOR


La Trobe University.",2020,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","['Eight community gymnasia', 'One hundred and sixty young people with disability aged 13 to 30 years', 'young people with disability']",['community-based exercise programme'],"['Primary (feasibility, participation and health-related quality of life']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.131616,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia n.shields@latrobe.edu.au.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Willis', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Imms', 'Affiliation': 'Centre for Disability and Development Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Prendergast', 'Affiliation': 'Department of Mathematics and Statistics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Watts', 'Affiliation': 'School of Health and Social Development, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Dorsselaer', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Bruder', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037153']
2267,32641340,Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial.,"INTRODUCTION


Sepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for further complications. Recent studies revealed a favourable impact of ketone bodies on resolution of inflammation. Thus, a ketogenic diet may provide an easy-to-apply and cost-effective treatment option potentially alleviating sepsis-evoked harm. This study is designed to assess the feasibility, efficiency and safety of a ketogenic diet in septic patients.
METHODS AND ANALYSIS


This monocentric study is a randomised, controlled and open-label trial, which is conducted on an intensive care unit of a German university hospital. As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied. The primary endpoint is the detection of ketone bodies in patients' blood and urine samples. As secondary endpoints, the impact on important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality) and the effect on the immune system are analysed.
ETHICS AND DISSEMINATION


The study has received the following approvals: Ethics Committee of the Medical Faculty of Ruhr-University Bochum (No. 18-6557-BR). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


German Clinical Trial Register (DRKS00017710); Universal Trial Number (U1111-1237-2493).",2020,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"['septic patients', 'intensive care unit of a German university hospital', 'septic patients on ICU']","['intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control', 'carbohydrate-reduced nutrition', 'ketogenic diet']","['important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality', 'feasibility, efficiency and safety', ""detection of ketone bodies in patients' blood and urine samples""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.164771,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rahmel', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany tim.rahmel@ruhr-uni-bochum.de.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Koos', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Katrin-Maria', 'Initials': 'KM', 'LastName': 'Willemsen', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Strauß', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Effinger', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Adamzik', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kreth', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038532']
2268,32641343,Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


The rapid worldwide spread of COVID-19 has caused a global health crisis. To date, symptomatic supportive care has been the most common treatment. It has been reported that the mechanism of COVID-19 is related to cytokine storms and subsequent immunogenic damage, especially damage to the endothelium and alveolar membrane. Vitamin C (VC), also known as L-ascorbic acid, has been shown to have antimicrobial and immunomodulatory properties. A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS). Therefore, we hypothesise that HIVC could be added to the treatment of ARDS and multiorgan dysfunction related to COVID-19.
METHODS AND ANALYSIS


The investigators designed a multicentre prospective randomised placebo-controlled trial that is planned to recruit 308 adults diagnosed with COVID-19 and transferred into the intensive care unit. Participants will randomly receive HIVC diluted in sterile water or placebo for 7 days once enrolled. Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded. The primary outcome is ventilation-free days within 28 observational days. This is one of the first clinical trials applying HIVC to treat COVID-19, and it will provide credible efficacy and safety data. We predict that HIVC could suppress cytokine storms caused by COVID-19, help improve pulmonary function and reduce the risk of ARDS of COVID-19.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of Zhongnan Hospital of Wuhan University (identifiers: Clinical Ethical Approval No. 2020001). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
TRIAL REGISTRATION NUMBER


NCT04264533.",2020,"A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS).","['308 adults diagnosed with COVID-19 and transferred into the intensive care unit', 'patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS', 'Patients with a history of VC allergy, end-stage pulmonary disease, advanced malignancy or glucose-6-phosphate dehydrogenase deficiency will be excluded', 'Zhongnan Hospital of Wuhan University (identifiers']","['intravenous VC (HIVC', 'HIVC diluted in sterile water or placebo', 'Intravenous high-dose vitamin C', 'Vitamin C (VC', 'placebo']","['ventilation-free days', 'pulmonary function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",308.0,0.489427,"A high dose of intravenous VC (HIVC) was proven to block several key components of cytokine storms, and HIVC showed safety and varying degrees of efficacy in clinical trials conducted on patients with bacterial-induced sepsis and acute respiratory distress syndrome (ARDS).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China Pengzy5@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-039519']
2269,32641367,Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND).,"INTRODUCTION


The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.
METHODS AND ANALYSIS


The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring  > 16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.
ETHICS AND DISSEMINATION


Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.
TRIAL REGISTRATION NUMBER


ISRCTN19674644.",2020,The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance.,"['treatment-resistant moderate to severe depression', '368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring  > 16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK', 'adults with moderate to severe treatment resistant depression']","['connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS', '20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance', 'Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation']","['HDRS-17 score', 'depression response', 'assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life', 'Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",368.0,0.369587,The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Psychiatry, University of Nottingham, Nottingham, UK richard.morriss@nottingham.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelghani', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dorothee P', 'Initials': 'DP', 'LastName': 'Auer', 'Affiliation': 'Arthritis Research UK Pain Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'University of Leicester, Leicester, Leicestershire, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bates', 'Affiliation': 'Nottingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blamire', 'Affiliation': 'University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Briley', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Iwabuchi', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'School of Medicine, University of Nottingham, nottingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kaylor-Hughes', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Lankappa', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Liddle', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McAllister-Williams', 'Affiliation': 'University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': ""O'Neill-Kerr"", 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Kettering, Northamptonshire, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pszczolkowski Parraguez', 'Affiliation': 'Precision Imaging Beacon, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Suazo Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Psychiatry, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Walters', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038430']
2270,32641706,Cerebellar transcranial alternating current stimulation in the gamma range applied during the acquisition of a novel motor skill.,"The development of novel strategies to augment motor training success is of great interest for healthy persons and neurological patients. A promising approach is the combination of training with transcranial electric stimulation. However, limited reproducibility and varying effect sizes make further protocol optimization necessary. We tested the effects of a novel cerebellar transcranial alternating current stimulation protocol (tACS) on motor skill learning. Furthermore, we studied underlying mechanisms by means of transcranial magnetic stimulation and analysis of fMRI-based resting-state connectivity. N = 15 young, healthy participants were recruited. 50 Hz tACS was applied to the left cerebellum in a double-blind, sham-controlled, cross-over design concurrently to the acquisition of a novel motor skill. Potential underlying mechanisms were assessed by studying short intracortical inhibition at rest (SICI rest ) and in the premovement phase (SICI move ), intracortical facilitation at rest (ICF rest ), and seed-based resting-state fMRI-based functional connectivity (FC) in a hypothesis-driven motor learning network. Active stimulation did not enhance skill acquisition or retention. Minor effects on striato-parietal FC were present. Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success. Accounting for the identified factors may allow to stratify participants for future training-based interventions.",2020,Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success.,"['N\u2009=\u200915 young, healthy participants were recruited', 'healthy persons and neurological patients']","['novel cerebellar transcranial alternating current stimulation protocol (tACS', 'Cerebellar transcranial alternating current stimulation']","['skill acquisition or retention', 'striato-parietal FC', 'motor skill learning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.090656,Linear mixed effects modelling identified SICI move  modulation and baseline task performance as the most influential determining factors for predicting training success.,"[{'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Wessel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland. maximilian.wessel@epfl.ch.'}, {'ForeName': 'Laurijn R', 'Initials': 'LR', 'LastName': 'Draaisma', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Anne F W', 'Initials': 'AFW', 'LastName': 'de Boer', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Maceira-Elvira', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Durand-Ruel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Philipp J', 'Initials': 'PJ', 'LastName': 'Koch', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Friedhelm C', 'Initials': 'FC', 'LastName': 'Hummel', 'Affiliation': 'Defitech Chair of Clinical Neuroengineering, Center for Neuroprosthetics (CNP) and Brain Mind Institute (BMI), Swiss Federal Institute of Technology (EPFL), Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-68028-9']
2271,32641723,Adaptive light: a lighting control method aligned with dark adaptation of human vision.,"Light exposure before sleep causes a reduction in the quality and duration of sleep. In order to reduce these detrimental effects of light exposure, it is important to dim the light. However, dimming the light often causes inconvenience and can lower the quality of life (QOL). We therefore aimed to develop a lighting control method for use before going to bed, in which the illuminance of lights can be ramped down with less of a subjective feeling of changes in illuminance. We performed seven experiments in a double-blind, randomized crossover design. In each experiment, we compared two lighting conditions. We examined constant illuminance, linear dimming, and three monophasic and three biphasic exponential dimming, to explore the fast and slow increases in visibility that reflect the dark adaptation of cone and rod photoreceptors in the retina, respectively. Finally, we developed a biphasic exponential dimming method termed Adaptive Light 1.0. Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change. This novel lighting method will help to develop new intelligent lighting instruments that reduce the negative effect of light on sleep and also lower energy consumption.",2020,Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change.,['human vision'],[],"['quality and duration of sleep', 'quality of life (QOL']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0215216,Adaptive Light 1.0 significantly prevented the misidentification seen in constant light and effectively suppressed perceptions of the illuminance change.,"[{'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Takemura', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Okano', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Okano', 'Affiliation': 'Department of Electrical Engineering and Bioscience, Graduate School of Sciences and Engineering, Waseda University, TWIns, Wakamatsucho 2-2, Shinjuku-Ku, Tokyo, 162-8480, Japan. okano@waseda.jp.'}]",Scientific reports,['10.1038/s41598-020-68119-7']
2272,32641747,Efficacy of eribulin for metastatic breast cancer based on localization of specific secondary metastases: a post hoc analysis.,"Prior pooled analysis of eribulin studies (301 and 305) indicated eribulin prolonged overall survival (OS) in patients with locally advanced/metastatic breast cancer (MBC) regardless of visceral or nonvisceral disease. This hypothesis-generating post hoc analysis examined the efficacy of eribulin according to the location of metastatic sites at baseline in 1864 pretreated patients with locally advanced/MBC from studies 301 and 305. Analyses included OS, progression-free survival (PFS), and objective response rate; OS and PFS were also analyzed according to estrogen-receptor status. Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline. A nominally significant difference in OS in favor of patients randomized to eribulin compared with control in patients with bone, lymph node, and chest wall/breast/skin metastases at baseline was observed. Additionally, a difference in OS was also seen in patients with liver metastases randomized to eribulin versus control (median: 13.4 versus 11.3 months, respectively; hazard ratio, 0.84 [95% CI: 0.72, 0.97]). Results of this exploratory analysis suggest that eribulin may be efficacious for the treatment of locally advanced/MBC for patients with bone, liver, lung, lymph node, and chest wall/breast/skin metastases.",2020,"Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline.","['patients with locally advanced/MBC', 'patients with locally advanced/metastatic breast cancer (MBC) regardless of visceral or nonvisceral disease', '1864 pretreated patients with locally advanced/MBC from studies 301 and 305']",['eribulin'],"['OS', 'eribulin prolonged overall survival (OS', 'OS, progression-free survival (PFS), and objective response rate; OS and PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}]","[{'cui': 'C2350866', 'cui_str': 'eribulin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",1864.0,0.0619688,"Eribulin appeared efficacious in patients with locally advanced/MBC, irrespective of the location of metastases at baseline.","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology and US Oncology, Dallas, TX, USA. joyce.oshaughnessy@usoncology.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona & Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': ""Leeds Institute of Medical Research at St James's and Leeds Teaching Hospitals Trust, Leeds, UK.""}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Goldstein', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Karenza', 'Initials': 'K', 'LastName': 'Alexis', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Scientific reports,['10.1038/s41598-020-66980-0']
2273,32641884,"Comparison of the efficacy and safety of indomethacin, ibuprofen, and paracetamol in the closure of patent ductus arteriosus in preterm neonates - A randomized controlled trial.","Introduction


In this prospective study, we compared the efficacy and safety of ibuprofen, indomethacin, and paracetamol in the closure of patent ductus arteriosus (PDA) in preterm neonates.
Materials and Methods


This randomized prospective study was conducted in the Division of Pediatric Cardiology, M. D. M and Umaid Hospital, Jodhpur. A total of 105 preterm neonates with gestational age <37 weeks and hemodynamically significant PDA (hs-PDA) diagnosed clinically and confirmed by echocardiography were enrolled. All neonates were randomly assigned in a ratio of 1:1:1 to oral indomethacin (Group A, 3 doses at an interval of 12 h with a starting dose of 0.2 mg/kg), oral ibuprofen (Group B, 10 mg/kg ibuprofen followed by 5 mg/kg/day for 2 days), or IV paracetamol (Group C, 15 mg/kg every 6 hourly for 3 consecutive days). After the completion of the first course, neonates were assessed clinically as well as by echocardiography to confirm PDA closure. If PDA remained open, the second course of the same drug was given and repeat assessment was done within 24 h of the last dose. In addition to an echocardiographic examination, complete blood counts, renal and liver function tests were performed.
Results


Our study shows that there was no significant difference observed in PDA closure among all the three treatment groups after the completion of two courses of treatment. The cumulative rate of PDA closure was 68% in the indomethacin group, 77.14% in the ibuprofen group, and 71.43% in the paracetamol group ( P  = 0.716). There were no significant changes found in Hb, platelet, blood urea nitrogen (BUN), creatinine, and liver enzymes after treatment in the paracetamol group ( P  > 0.05). BUN and serum creatinine levels were significantly increased after treatment in indomethacin and ibuprofen groups ( P  < 0.0001 and  P  < 0.05, respectively).
Conclusion


Our study shows that IV paracetamol is as effective as indomethacin and ibuprofen in promoting the closure of hs-PDA in premature infants with a better safety profile.",2020,"BUN and serum creatinine levels were significantly increased after treatment in indomethacin and ibuprofen groups ( P  < 0.0001 and  P  < 0.05, respectively).
","['patent ductus arteriosus in preterm neonates ', '105 preterm neonates with gestational age <37 weeks and hemodynamically significant PDA (hs-PDA) diagnosed clinically and confirmed by echocardiography were enrolled', 'premature infants', 'preterm neonates']","['indomethacin', 'ibuprofen, indomethacin, and paracetamol', 'oral indomethacin', 'indomethacin, ibuprofen, and paracetamol', 'paracetamol', 'indomethacin and ibuprofen', 'ibuprofen', 'oral ibuprofen']","['BUN and serum creatinine levels', 'efficacy and safety', 'cumulative rate of PDA closure', 'PDA closure', 'closure of patent ductus arteriosus (PDA', 'Hb, platelet, blood urea nitrogen (BUN), creatinine, and liver enzymes', 'echocardiographic examination, complete blood counts, renal and liver function tests']","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0190671', 'cui_str': 'Ligation of patent ductus arteriosus'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",105.0,0.0658683,"BUN and serum creatinine levels were significantly increased after treatment in indomethacin and ibuprofen groups ( P  < 0.0001 and  P  < 0.05, respectively).
","[{'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Meena', 'Affiliation': 'Department of Paediatric Medicine, Division of Paediatric Cardiology, Dr. S. N. Medical College, MDM Hospital for Mother and Child, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Durga Shankar', 'Initials': 'DS', 'LastName': 'Meena', 'Affiliation': 'Department of Medicine, AIIMS, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Pradeep Singh', 'Initials': 'PS', 'LastName': 'Rathore', 'Affiliation': 'Department of Paediatric Medicine, Division of Paediatric Cardiology, Dr. S. N. Medical College, MDM Hospital for Mother and Child, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Paediatric Medicine, Division of Paediatric Cardiology, Dr. S. N. Medical College, MDM Hospital for Mother and Child, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Jai Prakash', 'Initials': 'JP', 'LastName': 'Soni', 'Affiliation': 'Department of Paediatric Medicine, Division of Paediatric Cardiology, Dr. S. N. Medical College, MDM Hospital for Mother and Child, Jodhpur, Rajasthan, India.'}]",Annals of pediatric cardiology,['10.4103/apc.APC_115_19']
2274,32641925,"The effects of aerobic, resistance, and combined exercises on the plasma irisin levels, HOMA-IR, and lipid profiles in women with metabolic syndrome: A randomized controlled trial.","Background/objective


Irisin is suggested to be an exercise beneficial effects mediator. This study aimed to examine the effects of the aerobic exercise (AE), resistance exercise (RE), and combined exercise (CE) on the plasma levels of irisin and some metabolic and anthropometric indices.
Methods


Sixty overweight women with metabolic syndrome were assigned equally into four groups: AE, RE, CE, and control. The study variables were measured before and 24 h after the intervention period.
Results


None of the study groups showed statistically significant changes in the serum irisin. However, muscle mass significantly increased in the RE and CE groups. Also, a significant decrease was observed in the body fat percentage in all groups. In addition, compared with the control group, the homeostatic model assessment of insulin resistance in the AE (p = 0.021), RE (p = 0.039), and in the CE (p = 0.003) groups reduced significantly. According to the analysis of indices' changes, serum irisin was significantly correlated with the body fat percentage (r = 0.532) and HOMA-IR (r = 0.424).
Conclusions


The systematic exercise program for 8-weeks did not change circulating irisin and no statistically significant difference was observed between the exercise methods. Also, serum irisin seemed to be associated with the glycemic status, body fat and weight independent of exercise activity.
RCT registration code


IRCT20180806040721N2.
Registry name


Iranian Registry of Clinical Trials.",2020,"Conclusions


The systematic exercise program for 8-weeks did not change circulating irisin and no statistically significant difference was observed between the exercise methods.","['Sixty overweight women with metabolic syndrome', 'women with metabolic syndrome']","['aerobic exercise (AE), resistance exercise (RE), and combined exercise (CE', 'aerobic, resistance, and combined exercises']","['body fat percentage', 'homeostatic model assessment of insulin resistance', 'serum irisin', 'muscle mass', 'glycemic status, body fat and weight independent of exercise activity', 'plasma irisin levels, HOMA-IR, and lipid profiles', 'plasma levels of irisin and some metabolic and anthropometric indices']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0335369,"Conclusions


The systematic exercise program for 8-weeks did not change circulating irisin and no statistically significant difference was observed between the exercise methods.","[{'ForeName': 'Aria', 'Initials': 'A', 'LastName': 'Dianatinasab', 'Affiliation': 'Department of Biochemistry, Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Koroni', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Bahramian', 'Affiliation': 'Department of Psychiatry, School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri-Hosseinabadi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fararouei', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Amanat', 'Affiliation': 'Department of Nutrition, School of Health, Larestan University of Medical Sciences, Larestan, Iran.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.06.004']
2275,32641966,A Randomized Clinical Trial of Elemental Zinc Add-on Therapy on Clinical Outcomes of Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).,"Recent studies suggest a relationship between zinc deficiency and inflammation. In the present study, we studied the effect of oral zinc supplementation on clinical improvement of chronic rhinosinusitis with nasal polyposis. In this single-blind randomized controlled trial, 44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014 were randomly allocated in two groups. The treatment group (n = 28) was treated with a four-drug fixed-dose regimen (FD_FDR) consisting of oral dexamethasone (0.02 mg/kg), fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc, b.d., and the control group (n = 16) received the FD_FDR without supplemental zinc, for six weeks. After sixth week, two groups were compared regarding clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems. In the treatment group, serum zinc levels were significantly increased compared to those at the baseline (1.33 fold-increase;  p  = 0.0002). Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK). Incontrast, between groups analysis revealed no significant differences in the LM and LK. The treatment group showed a mild superiority in general health improvement compared to that of the control group. Add-on therapy with supplemental zinc sulfate was not associated with significant improvement in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). The advantage of zinc supplementation on the general health improvement of the patients with CRSwNP requires further assessments.",2019,Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK).,"['chronic rhinosinusitis with nasal polyposis', 'Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP', 'patients with chronic rhinosinusitis with nasal polyposis (CRSwNP', '44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014']","['FD_FDR without supplemental zinc', 'supplemental zinc sulfate', 'oral zinc supplementation', 'zinc supplementation', 'oral dexamethasone', 'fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc', 'Elemental Zinc Add-on Therapy']","['general health improvement', 'serum zinc levels', 'clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems', 'LM and LK']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0360577', 'cui_str': 'Fluticasone-containing product in nasal dose form'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1145935', 'cui_str': 'montelukast 10 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",44.0,0.132435,Within groups analysis revealed a significant reduction ( p  < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK).,"[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Akbari Dilmaghani', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nadereh', 'Initials': 'N', 'LastName': 'Alani', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Fazeli', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100767']
2276,32641967,"Effect of a Natural Eye Drop, Made of  Plantago Ovata  Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial.","Dry eye disease is a relatively common eye disorder associated with decrease in quality of life. In this study, efficacy of an eye drop of  Plantago ovata  mucilage on symptoms of dry eye disease was evaluated. In a randomized, double-blind, placebo-controlled clinical trial, sixty dry eye patients with ocular symptoms and total Ocular Surface Disease Index (OSDI) score of ≥12 were randomly assigned to receive either a natural ophthalmic drop, made of  Plantago ovata  mucilage or placebo 4 times a day for 6 weeks. The patients were evaluated at pretreatment (baseline), weeks 4 and 6 post-treatment. The evaluation of the efficacy and safety were conducted based on the OSDI questionnaire, the noninvasive tear film break-up time (NI-BUT) with keratograph, the Schirmer test without anesthesia, and the osmolarity test, as well as by monitoring possible adverse events. After 6 weeks, within group analysis showed a significant improvement in total OSDI score ( p  < 0.001). In addition, between group comparison revealed a significant improvement in the OSDI score of the intervention group ( p  < 0.001). Although, NI-BUT was significantly improved in the  Plantago ovata  group ( p  = 0.004), however no statistically significant difference was observed in between group analysis. There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test. No serious adverse events were reported. In conclusion,  P. ovata  mucilage is a natural, inexpensiveness, and safe lubricant polymer that could have beneficial ocular effects on subjective symptoms of the patients with dry eye disease.",2019,"There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test.","['patients with dry eye disease', 'sixty dry eye patients with ocular symptoms and total Ocular Surface Disease Index (OSDI) score of ≥12']","['Natural Eye Drop, Made of  Plantago Ovata  Mucilage', 'natural ophthalmic drop, made of  Plantago ovata  mucilage or placebo', 'placebo']","['quality of life', 'total OSDI score', 'NI-BUT', 'OSDI score', 'efficacy and safety', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C1209192', 'cui_str': 'Plantago ovata'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.268929,"There were no significant differences between two groups, or significant changes within the groups in the Schirmer test without anesthesia and the osmolarity test.","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haji-Ali-Nili', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Khoshzaban', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Department of Iranian Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Roja', 'Affiliation': 'Department of Traditional Pharmacy, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ashrafi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghaffari', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Traditional Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Jabarvand Behrouz', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100717']
2277,32641968,Comparative Study of the Effects of Chamomile ( Matricaria Chamomilla  L.) and Cabergoline on Idiopathic Hyperprolactinemia: A Pilot Randomized Controlled Trial.,"Chamomile is a fascinating plant quoted in several traditional medicine texts, which has broad-spectrum pharmacological activity and medicinal uses. The aim of this study was to assess the efficacy of chamomile syrup in reducing serum prolactin in women with idiopathic hyperprolactinemia. The study was a randomized, controlled clinical trial that was conducted on 56 women with idiopathic hyperprolactinemia for a study period of four weeks. Patients were randomly enrolled in two parallel arms and were treated by chamomile syrup at a dose of 5 mL twice daily or cabergoline tablet orally at a dose of 0.25 mg twice weekly. Serum prolactin levels were measured at baseline and the end of the 4-week study period. Any report of adverse events was also recorded. Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001). It was also found that decline in the mean prolactin level was statistically significant within the chamomile group ( p  <0.0001). Chamomile syrup seems to be effective on serum prolactin reduction in women with idiopathic hyperprolactinemia. However, studies with a larger sample size and for a longer follow-up period are recommended.",2019,Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001).,"['Idiopathic Hyperprolactinemia', 'women with idiopathic hyperprolactinemia', '56 women with idiopathic hyperprolactinemia for a study period of four weeks']","['chamomile syrup', 'Chamomile ( Matricaria Chamomilla  L.) and Cabergoline', 'cabergoline tablet', 'cabergoline']","['serum prolactin reduction', 'adverse events', 'mean prolactin level', 'Serum prolactin levels', 'serum prolactin']","[{'cui': 'C0271552', 'cui_str': 'Idiopathic hyperprolactinemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0939806', 'cui_str': 'Matricaria recutita extract'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C1245215', 'cui_str': 'cabergoline Oral Tablet'}]","[{'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",56.0,0.043982,Results revealed that within the cabergoline group the reduction in the mean prolactin level was significantly greater than that of the chamomile group ( p  <0.0001).,"[{'ForeName': 'Marya', 'Initials': 'M', 'LastName': 'Kabiri', 'Affiliation': 'School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Bioos', 'Affiliation': 'School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mamak', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Institute of Family Health, Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Sohrabvand', 'Affiliation': 'Vali-e-Asr Hospital, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.1100758']
2278,32641970,A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran.,"We compared the efficacy and safety of a biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of relapsing remitting multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the biosimilar medication and the reference treatment (30 μg intramuscular, weekly for one year). We investigated changes in EDSS, relapse rate and MRI changes within one year. In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32.4 ± 8.8 and 31.5 ± 8 for the biosimilar medication and the reference arm respectively. One-year follow-up revealed a mean difference of 0.084 in EDSS (95% CI: 0.069-0.237) between the two groups in favor of the biosimilar medication. This value did not exceed the predefined non-inferiority margin of 0.1. There were no statistically significant differences in relapse rate and systemic and local adverse events of the two groups. The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety. In conclusion the biosimilar interferon 1-a can be considered as an effective and safe alternative to the reference product due to lower cost and more availability.",2019,The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety.,"['relapsing remitting multiple sclerosis (RRMS', 'In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32.4 ± 8.8 and 31.5 ± 8 for the biosimilar medication and the reference arm respectively', '138 patients with RRMS']","['Biosimilar Form of Intramuscular Βeta-interferon I', 'biosimilar medication', 'biosimilar form of beta-interferon-1a (Actovex']","['efficacy and safety', 'relapse rate and systemic and local adverse events', 'EDSS, relapse rate and MRI changes']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",138.0,0.0550926,The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety.,"[{'ForeName': 'Seyed Massood', 'Initials': 'SM', 'LastName': 'Nabavi', 'Affiliation': 'Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Abolfazli', 'Affiliation': 'Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Etemadrezaei', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Shefa Neuroscience Research Center, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Shahriari', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Baharak', 'Initials': 'B', 'LastName': 'Mehdipour', 'Affiliation': 'Actoverco Pharmaceuticals, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shekarchi', 'Affiliation': 'Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Soltanzadeh', 'Affiliation': 'Department of Neurology, Faculty of Medical, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.14503.12441']
2279,32642070,The feasibility of a randomised control trial to assess physiotherapy against surgery for recurrent patellar instability.,"Background


Patellar instability is a relatively common condition that leads to disability and restriction of activities. People with recurrent instability may be given the option of physiotherapy or surgery though this is largely driven by clinician preference rather than by a strong evidence base. We sought to determine the feasibility of conducting a definitive trial comparing physiotherapy with surgical treatment for people with recurrent patellar instability.
Methods


This was a pragmatic, open-label, two-arm feasibility randomised control trial (RCT) with an embedded interview component recruiting across three NHS sites comparing surgical treatment to a package of best conservative care; 'Personalised Knee Therapy' (PKT). The primary feasibility outcome was the recruitment rate per centre (expected rate 1 to 1.5 participants recruited each month). Secondary outcomes included the rate of follow-up (over 80% expected at 12 months) and a series of participant-reported outcomes taken at 3, 6 and 12 months following randomisation, including the Norwich Patellar Instability Score (NPIS), the Kujala Patellofemoral Disorder Score (KPDS), EuroQol-5D-5L, self-reported global assessment of change, satisfaction at each time point and resources use.
Results


We recruited 19 participants. Of these, 18 participants (95%) were followed-up at 12 months and 1 (5%) withdrew. One centre recruited at just over one case per month, one centre was unable to recruit, and one centre recruited at over one case per month after a change in participant screening approach. Ten participants were allocated into the PKT arm, with nine to the surgical arm. Mean Norwich Patellar Instability Score improved from 40.6 (standard deviation 22.1) to 28.2 (SD 25.4) from baseline to 12 months.
Conclusion


This feasibility trial identified a number of challenges and required a series of changes to ensure adequate recruitment and follow-up. These changes helped achieve a sufficient recruitment and follow-up rate. The revised trial design is feasible to be conducted as a definitive trial to answer this important clinical question for people with chronic patellar instability.
Trial registration


The trial was prospectively registered on the International Standard Randomised Controlled Trial Number registry on the 22/12/2016 (reference number: ISRCTN14950321). http://www.isrctn.com/ISRCTN14950321.",2020,"Mean Norwich Patellar Instability Score improved from 40.6 (standard deviation 22.1) to 28.2 (SD 25.4) from baseline to 12 months.
","['people with recurrent patellar instability', 'recurrent patellar instability', 'people with chronic patellar instability', '19 participants']","['physiotherapy against surgery', 'physiotherapy with surgical treatment', ""embedded interview component recruiting across three NHS sites comparing surgical treatment to a package of best conservative care; 'Personalised Knee Therapy' (PKT""]","['rate of follow-up', 'recruitment rate per centre', 'Mean Norwich Patellar Instability Score', 'Norwich Patellar Instability Score (NPIS), the Kujala Patellofemoral Disorder Score (KPDS), EuroQol-5D-5L, self-reported global assessment of change, satisfaction at each time point and resources use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1997635', 'cui_str': 'Patellar instability'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997635', 'cui_str': 'Patellar instability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0409325', 'cui_str': 'Disorder of patellofemoral joint'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",10.0,0.184872,"Mean Norwich Patellar Instability Score improved from 40.6 (standard deviation 22.1) to 28.2 (SD 25.4) from baseline to 12 months.
","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rahman', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gemperle-Mannion', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Qureshi', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Edwin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'T O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics and Rheumatology, University of Oxford, Oxford, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Health Economics Department, Warwick Medical School, University of Warwick, Warwick, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Eldridge', 'Affiliation': 'Bristol Royal Infirmary, University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-020-00635-9']
2280,32642091,Real-life effectiveness of fluticasone furoate/vilanterol after switching from fluticasone/salmeterol or budesonide/formoterol therapy in patients with symptomatic asthma: Relvar Ellipta for Real Asthma Control Study (RERACS study).,"Background


This study evaluated the efficacy of switching therapy from fluticasone propionate/salmeterol (FP/SM) or budesonide/formoterol (BD/FM) to fluticasone furoate and vilanterol (FF/VI) at the equivalent corticosteroid dose in a real-world setting.
Methods


A prospective, 3-month, open-label, parallel group, switching therapy trial was performed in symptomatic asthma patients under routine management. Patients using 1 puff of FP 250 µg/SM 50 µg b.i.d or 2 puffs of BD 160 µg/FM 4.5 µg b.i.d were switched to FF 100 µg/VI 25 µg once daily, while patients using 1 puff of FP 500 µg/SM 50 µg b.i.d or 4 puffs of BD 160/FM b.i.d was switched to FF 200 µg/VI 25 µg once daily. The primary outcome was improvement of the predicted forced expiratory volume in 1 second % (%FEV1), while secondary outcomes were improvement of asthma symptoms evaluated by the asthma control test (ACT) and fractional exhaled nitric oxide (FeNO).
Results


The %FEV1 was improved at 4 weeks after switching, and the improvement was maintained until 12 weeks. ACT also improved after switching. Patients with ACT <20 before switching showed greater improvement of symptoms at 4 weeks and 62% had an ACT score >20. FeNO decreased from 8 weeks.
Conclusions


In symptomatic asthma patients showing insufficient control, improvement of asthma was obtained by switching to FF/VI at the equivalent corticosteroid dose accompanied with the improvement of biomarkers. FF/VI can be a useful option for better control of asthma because of its high efficacy, long duration of action, and delivery via a single-action device.",2020,Patients with ACT <20 before switching showed greater improvement of symptoms at 4 weeks and 62% had an ACT score >20.,"['symptomatic asthma patients under routine management', 'patients with symptomatic asthma']","['fluticasone furoate/vilanterol', 'fluticasone furoate and vilanterol (FF/VI', 'fluticasone propionate/salmeterol (FP/SM) or budesonide/formoterol (BD/FM', 'fluticasone/salmeterol or budesonide/formoterol therapy']","['predicted forced expiratory volume', 'improvement of symptoms', 'asthma symptoms evaluated by the asthma control test (ACT) and fractional exhaled nitric oxide (FeNO', 'FeNO']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",,0.380187,Patients with ACT <20 before switching showed greater improvement of symptoms at 4 weeks and 62% had an ACT score >20.,"[{'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Shiobara', 'Affiliation': 'Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Arai', 'Affiliation': 'Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Chibana', 'Affiliation': 'Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takemasa', 'Affiliation': 'Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.'}]",Journal of thoracic disease,['10.21037/jtd-19-3913']
2281,32642114,The use of prefilled adrenaline syringes improves cardiopulmonary resuscitation quality-high-fidelity simulator-based study.,"Background


In some countries, adrenaline is available only in glass ampoules. However, simplification of cardiopulmonary resuscitation (CPR) by introducing prefilled syringes may ensure more efficient CPR. The aim of this study was to investigate the impact of different forms of adrenaline on the CPR quality.
Methods


In a randomized cross-examination simulation study, 100 two-person paramedical teams took part in two 10-minute scenarios of sudden cardiac arrest (SCA) in a pulseless electrical activity mechanism (PEA). In the first scenario the set of medicines contained glass ampoules (group ST) with adrenaline, in the second prefilled syringes (group AMPS). The parameters of the CPR quality [correct number and depth of chest compressions (CC), no flow time, chest recoil, time to apply supraglottic airways device (SAD)] were compared.
Results


In group AMPS the first dose of adrenaline was administered after 114.2±28.3 seconds after the initiation of CPR whereas after 178.1±62.6 seconds in group ST (P<0.001). Chest compression fraction (CCF) was higher (81.8%±6.1%) in group AMPS than in group ST (71.2%±7.5%). Paramedics performed CC at better frequency, to a preferred depth and in an appropriate place in group AMPS. Faster decision to apply SAD (131.7±34.0 s in group AMPS and 220.3±81.5 s in group ST) ensured faster achievement of airway patency in this group (181.5±48.7  vs.  271.2±101.5 s).
Conclusions


Prefilled syringes with crucial drugs during CPR may significantly improve the quality of CPR performed by two-person teams.",2020,Chest compression fraction (CCF) was higher (81.8%±6.1%) in group,['100 two-person paramedical teams took part in two 10-minute scenarios of sudden cardiac arrest (SCA) in a pulseless electrical activity mechanism (PEA'],"['adrenaline', 'prefilled adrenaline syringes', 'AMPS']","['faster achievement of airway patency', 'CPR quality [correct number and depth of chest compressions (CC), no flow time, chest recoil, time to apply supraglottic airways device (SAD', 'Chest compression fraction (CCF', 'CPR quality', 'cardiopulmonary resuscitation quality', 'quality of CPR']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1720824', 'cui_str': 'Cardiac Arrest, Sudden'}, {'cui': 'C0340861', 'cui_str': 'Electromechanical dissociation'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.0273597,Chest compression fraction (CCF) was higher (81.8%±6.1%) in group,"[{'ForeName': 'Radosław', 'Initials': 'R', 'LastName': 'Zalewski', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Puślecki', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kłosiewicz', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Sip', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Perek', 'Affiliation': 'Department of Cardiac Surgery and Transplantology, Poznan University of Medical Sciences, Poznań, Poland.'}]",Journal of thoracic disease,['10.21037/jtd.2020.04.33']
2282,32642124,Preoperative individualized education intervention reduces delirium after cardiac surgery: a randomized controlled study.,"Background


Postoperative delirium dramatically increases the mortality and morbidity of patients undergoing cardiac surgery. Preoperative education has been proven to be effective in improving recovery and reducing complications. However, there is rare evidence of individualized education for the delirium. This study aimed to investigate the effect of preoperative personalized education on postoperative delirium of patients undergoing cardiac surgery.
Methods


A total of 133 adult patients receiving cardiac surgery in a single center were enrolled in this study and randomized into the experimental group (n=67) and the control group (n=66), who were given the preoperative individualized education intervention and routine care respectively. The primary endpoint of delirium and other clinical outcomes were observed and compared.
Results


All patients completed this trial without a significant difference between the two groups in baseline characteristics. The incidence of the delirium of the experimental group was significantly lower than that of the control group (10.4%  vs.  24.2%, P=0.038). There was no statistical difference between two groups in hospital-stay and other complications, while the mechanical ventilation time and ICU stay of the experimental group was significantly lower (MV time: 13.7±7.6  vs.  18.6±9.8 h, P=0.002; ICU stay: 31.3±9.1  vs.  36.5±10.4 h, P=0.003).
Conclusions


Preoperative individualized education intervention can reduce the incidence of postoperative delirium and promote the recovery of patients receiving cardiac surgery.",2020,"There was no statistical difference between two groups in hospital-stay and other complications, while the mechanical ventilation time and ICU stay of the experimental group was significantly lower (MV time: 13.7±7.6  vs.  18.6±9.8 h, P=0.002; ICU stay:","['after cardiac surgery', 'patients receiving cardiac surgery', '133 adult patients receiving cardiac surgery in a single center', 'patients undergoing cardiac surgery']","['preoperative individualized education intervention and routine care respectively', 'Preoperative individualized education intervention', 'preoperative personalized education']","['delirium and other clinical outcomes', 'mortality and morbidity', 'hospital-stay and other complications', 'delirium', 'mechanical ventilation time and ICU stay', 'ICU stay', 'incidence of the delirium']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",133.0,0.0758533,"There was no statistical difference between two groups in hospital-stay and other complications, while the mechanical ventilation time and ICU stay of the experimental group was significantly lower (MV time: 13.7±7.6  vs.  18.6±9.8 h, P=0.002; ICU stay:","[{'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Center for Comprehensive Treatment of Atrial Fibrillation, Department of Cardiothoracic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Center for Comprehensive Treatment of Atrial Fibrillation, Department of Cardiothoracic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Comprehensive Treatment of Atrial Fibrillation, Department of Cardiothoracic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Center for Comprehensive Treatment of Atrial Fibrillation, Department of Cardiothoracic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Nursing, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}, {'ForeName': 'Zhinong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Center for Comprehensive Treatment of Atrial Fibrillation, Department of Cardiothoracic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.04.26']
2283,32642147,"ATTACHED, DETACHED and WITHOUT inhaler technique coaching tools to optimize pMDI use competence, asthma control and quality-of-life in asthmatic adults.","Background


Poor pressurized metered dose inhaler (pMDI) technique is prevalent, which will diminish treatment gains. In a two-visit study, two novel pMDI training devices with feedback mechanisms; Trainhaler (THR) and Flo-Tone CR (FTCR), were evaluated alongside the traditional verbal inhaler training (VT) in asthma outpatients.
Methods


On visit 1, 18-60 year-old asthmatics with incorrect pMDI use [including peak inhalation flow (PIF) >60 L/min] signed consent and baseline pMDI technique, lung function, asthma control and quality-of-life were measured. Participants were randomized to receive pMDI technique training using VT, THR or FTCR. One hour post-training, the pMDI coordination and PIF were re-assessed. The THR and FTCR patients were given their assigned tools to take home to facilitate regular training. All outcomes were re-evaluated 6-8 weeks later (visit 2).
Results


Ninety-two asthmatics completed visit 1 (46 attended visit 2). Pre-training, 61.3% (VT), 61.5% (THR) and 65.0% (FTCR) patients similarly made ≥2 pMDI errors with mean PIFs 175.2, 187.1 and 158.9 L/min, respectively. pMDI use was significantly improved 1 h post-training. The subjects that completed visit 2 had significantly, yet equally, maintained the improved inhaler use; only 28.0% (VT), 26.2% (THR) and 21.7% (FTCR) patients made ≥2 pMDI errors with PIF improvements; 115.3, 94.6 and 96.1 L/min, respectively. Clinical outcomes remained comparable.
Conclusions


VT improves the overall pMDI technique, however patients gradually forget their VT. The THR and FTCR devices are retained by the patients as their self-monitoring, all-time personal trainers that boost and maintain their VT between routine clinic visits.",2020,"The subjects that completed visit 2 had significantly, yet equally, maintained the improved inhaler use; only 28.0% (VT), 26.2% (THR) and 21.7% (FTCR) patients made ≥2 pMDI errors with PIF improvements; 115.3, 94.6 and 96.1 L/min, respectively.","['asthmatic adults', 'asthma outpatients']","['novel pMDI training devices with feedback mechanisms; Trainhaler (THR) and Flo-Tone CR (FTCR), were evaluated alongside the traditional verbal inhaler training (VT', 'pMDI technique training using VT, THR or FTCR']","['overall pMDI technique', 'pMDI use', 'peak inhalation flow (PIF) >60 L/min] signed consent and baseline pMDI technique, lung function, asthma control and quality-of-life']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",92.0,0.0272628,"The subjects that completed visit 2 had significantly, yet equally, maintained the improved inhaler use; only 28.0% (VT), 26.2% (THR) and 21.7% (FTCR) patients made ≥2 pMDI errors with PIF improvements; 115.3, 94.6 and 96.1 L/min, respectively.","[{'ForeName': 'Wesam G', 'Initials': 'WG', 'LastName': 'Ammari', 'Affiliation': 'Pharmacological and Diagnostic Research Centre (PDRC), Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, Jordan.'}, {'ForeName': 'Nathir M', 'Initials': 'NM', 'LastName': 'Obeidat', 'Affiliation': 'Faculty of Medicine and Jordan University Hospital, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Abed Rahman', 'Initials': 'AR', 'LastName': 'Anani', 'Affiliation': 'Anani Respiratory Medicine Clinics, Amman, Jordan.'}, {'ForeName': 'Reem J', 'Initials': 'RJ', 'LastName': 'AlKalbani', 'Affiliation': 'Faculty of Medicine and Jordan University Hospital, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Clement Clarke International Limited, Harlow, UK.'}]",Journal of thoracic disease,['10.21037/jtd.2020.03.50']
2284,32636777,Repetitive Transcranial Magnetic Stimulation Improved Source Memory and Modulated Recollection-Based Retrieval in Healthy Older Adults.,"Source memory is one of the cognitive abilities that are most vulnerable to aging. Luckily, the brain plasticity could be modulated to counteract the decline. The repetitive transcranial magnetic stimulation (rTMS), a relatively non-invasive neuro-modulatory technique, could directly modulate neural excitability in the targeted cortical areas. Here, we are interested in whether the application of rTMS could enhance the source memory performance in healthy older adults. In addition, event-related potentials (ERPs) were employed to explore the specific retrieval process that rTMS could affect. Subjects were randomly assigned to either the rTMS group or the sham group. The rTMS group received 10 sessions (20 min per session) of 10 Hz rTMS applying on the right dorsolateral prefrontal cortex (i.e., F4 site), and the sham group received 10 sessions of sham stimulation. Both groups performed source memory tests before and after the intervention while the electroencephalogram (EEG) was recorded during the retrieval process. Behavioral results showed that the source memory performance was significantly improved after rTMS compared with the sham stimulation; ERPs results showed that during the retrieval phase, the left parietal old/new effect, which reflected the process of recollection common to both young and old adults, increased in the rTMS group compared with the sham stimulation group, whereas the late reversed old/new effect specific to the source retrieval of older adults showed similar attenuation after intervention in both groups. The present results suggested that rTMS could be an effective intervention to improve source memory performance in healthy older adults and that it selectively facilitated the youth-like recollection process during retrieval. This study was registered in the Chinese Clinical Trial Registry (ChiCTR) with the identifier chictr-ire-15006371.",2020,"Behavioral results showed that the source memory performance was significantly improved after rTMS compared with the sham stimulation; ERPs results showed that during the retrieval phase, the left parietal old/new effect, which reflected the process of recollection common to both young and old adults, increased in the rTMS group compared with the sham stimulation group, whereas the late reversed old/new effect specific to the source retrieval of older adults showed similar attenuation after intervention in both groups.","['healthy older adults', 'Healthy Older Adults']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation Improved Source Memory and Modulated Recollection-Based Retrieval', '10 Hz rTMS applying on the right dorsolateral prefrontal cortex (i.e., F4 site), and the sham group received 10 sessions of sham stimulation']","['source memory performance', 'electroencephalogram (EEG']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",,0.031569,"Behavioral results showed that the source memory performance was significantly improved after rTMS compared with the sham stimulation; ERPs results showed that during the retrieval phase, the left parietal old/new effect, which reflected the process of recollection common to both young and old adults, increased in the rTMS group compared with the sham stimulation group, whereas the late reversed old/new effect specific to the source retrieval of older adults showed similar attenuation after intervention in both groups.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'CAS Key Laboratory of Mental Health, Center on Aging Psychology, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Weicong', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': 'CAS Key Laboratory of Mental Health, Center on Aging Psychology, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'CAS Key Laboratory of Mental Health, Center on Aging Psychology, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'CAS Key Laboratory of Mental Health, Center on Aging Psychology, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01137']
2285,32636793,Blood Pressure Target in Acute Stroke to Reduce HemorrhaGe After Endovascular Therapy: The Randomized BP TARGET Study Protocol.,"Background:  High systolic blood pressure (BP) is associated with an increased risk of intracranial hemorrhage (ICH) in patients undergoing reperfusion therapy. However, there are no data from randomized trials to guide BP management after reperfusion following endovascular therapy (EVT) for patients with acute ischemic stroke (AIS) with large vessel occlusion (LVO). The objective is to evaluate if BP control with a target of 100-129 mmHg systolic BP (""tight"" SBP control) can reduce ICH as compared to 130-185 mmHg (""usual"" SBP control) in AIS participants after reperfusion by EVT.  Methods:  The BP TARGET trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial. AIS participants with LVO experiencing successful reperfusion are randomly assigned, in a 1:1 ratio, to have a ""tight"" SBP control (100-129 mmHg) or a conservative SBP control (130-185 mmHg) during the following 24-36 h. The primary outcome is the rate of ICH (either symptomatic or asymptomatic) on follow-up CT scan at 24-36 h. Secondary outcomes include the rate of the symptomatic ICH, the overall distribution of the modified Rankin Scale (mRS) at 90 days, favorable outcome (90-day mRs 0-2), infarct volume at follow-up CT scan at 24-36 h, change in National Institute of Health Stroke Scale at 24 h, and all-cause mortality at 90 days.  Conclusion:  This is the first randomized trial directly comparing the efficacy of different SBP targets after EVT reperfusion. This prospective trial aims to determine whether a ""tight"" SBP control after EVT reperfusion can reduce the risk of ICH.",2020,"The primary outcome is the rate of ICH (either symptomatic or asymptomatic) on follow-up CT scan at 24-36 h. Secondary outcomes include the rate of the symptomatic ICH, the overall distribution of the modified Rankin Scale (mRS) at 90 days, favorable outcome (90-day mRs 0-2), infarct volume at follow-up CT scan at 24-36 h, change in National Institute of Health Stroke Scale at 24 h, and all-cause mortality at 90 days.  ","['AIS participants with LVO experiencing successful reperfusion', 'patients undergoing reperfusion therapy', 'patients with acute ischemic stroke (AIS) with large vessel occlusion (LVO']","['Endovascular Therapy', 'conservative SBP control', ':  High systolic blood pressure (BP', 'endovascular therapy (EVT']","['intracranial hemorrhage (ICH', 'rate of the symptomatic ICH, the overall distribution of the modified Rankin Scale (mRS) at 90 days, favorable outcome (90-day mRs 0-2), infarct volume at follow-up CT scan at 24-36 h, change in National Institute of Health Stroke Scale', 'HemorrhaGe', 'rate of ICH (either symptomatic or asymptomatic) on follow-up CT scan']","[{'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277884', 'cui_str': 'Increased systolic arterial pressure'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0202657', 'cui_str': 'Computerized tomography, follow-up'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",,0.111667,"The primary outcome is the rate of ICH (either symptomatic or asymptomatic) on follow-up CT scan at 24-36 h. Secondary outcomes include the rate of the symptomatic ICH, the overall distribution of the modified Rankin Scale (mRS) at 90 days, favorable outcome (90-day mRs 0-2), infarct volume at follow-up CT scan at 24-36 h, change in National Institute of Health Stroke Scale at 24 h, and all-cause mortality at 90 days.  ","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'University of Lille, CHU Lille, EA 2694, Santé Publique: Épidémiologie et Qualité des Soins, Lille, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Division of Neurology, Department of Neurology, Stroke Center, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': 'Pôle des Neurosciences Cliniques, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Berge', 'Affiliation': 'Interventional and Diagnostic Neuroradiology Department, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Olivot', 'Affiliation': 'Stroke Unit, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Reiner', 'Affiliation': 'Department of Neurology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhammel', 'Affiliation': 'University of Lille, CHU Lille, EA 2694, Santé Publique: Épidémiologie et Qualité des Soins, Lille, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Maier', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Yavchitz', 'Affiliation': 'Department of Clinical Research, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Salomon', 'Affiliation': 'Department of Clinical Research, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Stroke Unit, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Savatovsky', 'Affiliation': 'Department of Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital, Paris, France.'}]",Frontiers in neurology,['10.3389/fneur.2020.00480']
2286,32636879,"Comparison of the Effects of Desflurane, Sevoflurane, and Propofol on the Glottic Opening Area during Remifentanil-Based General Anesthesia Using a Supraglottic Airway Device.","Purpose


The aim of this study was to compare the effects of desflurane, sevoflurane, and propofol on the glottic opening area during general anesthesia using remifentanil.
Methods


Ninety patients undergoing hand and upper limb surgery combined with brachial plexus block under general anesthesia were enrolled in the study. The patients were randomized into three groups to receive desflurane (group D), sevoflurane (group S), or propofol (group P) for maintenance of anesthesia. Following induction of general anesthesia with remifentanil, continuous fiberoptic video recording around the glottis via an i-gel™ supraglottic device was started after establishing mechanical ventilation. Desflurane, sevoflurane, or propofol was administrated after video recording was started. The changes in normalized glottic opening area (n-GOA) and peak inspiratory pressure (PIP) during surgery were compared between the three groups.
Results


Intraoperative changes of n-GOA in group D showed significant differences compared with group S and group P (-0.0656 ± 0.0772 vs. -0.0076 ± 0.0499 and +0.0269 ± 0.0809,  P =0.005 and  P  < 0.0001). The changes of PIP in group D showed significant differences compared with group S and group P (+3.7 ± 3.4 cmH 2 O vs. +1.0 ± 1.3 cmH 2 O and -0.3 ± 3.6 cmH 2 O,  P =0.002 and  P  < 0.0001). Four cases of relapsed glottic stenosis in group D were improved by changing desflurane to propofol.
Conclusions


Desflurane narrowed the n-GOA and increased the PIP compared to sevoflurane and propofol during general anesthesia with remifentanil. Clinicians should be aware of the possibility of glottic stenosis during desflurane-remifentanil anesthesia when the airway is secured by a supraglottic airway device without the use of neuromuscular blockade.",2020,"Results


Intraoperative changes of n-GOA in group D showed significant differences compared with group S and group P (-0.0656 ± 0.0772 vs. -0.0076 ± 0.0499 and +0.0269 ± 0.0809,  P =0.005 and  P  < 0.0001).","['Ninety patients undergoing hand and upper limb surgery combined with brachial plexus block under general anesthesia were enrolled in the study', 'Glottic Opening Area during Remifentanil-Based General Anesthesia Using a Supraglottic Airway Device']","['desflurane, sevoflurane, and propofol', 'desflurane', 'remifentanil, continuous fiberoptic video recording around the glottis via an i-gel™ supraglottic device', 'Desflurane, sevoflurane, or propofol', 'remifentanil', 'Desflurane, Sevoflurane, and Propofol', 'desflurane-remifentanil anesthesia', 'sevoflurane', 'propofol']","['relapsed glottic stenosis', 'normalized glottic opening area (n-GOA) and peak inspiratory pressure (PIP']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}]",90.0,0.0355848,"Results


Intraoperative changes of n-GOA in group D showed significant differences compared with group S and group P (-0.0656 ± 0.0772 vs. -0.0076 ± 0.0499 and +0.0269 ± 0.0809,  P =0.005 and  P  < 0.0001).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Izumi', 'Affiliation': 'Department of Anesthesia, Akane Foundation Tsuchiya General Hospital, Hiroshima, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Anesthesia, Akane Foundation Tsuchiya General Hospital, Hiroshima, Japan.'}]",Anesthesiology research and practice,['10.1155/2020/1302898']
2287,32636883,Best Time for Levothyroxine Intake in Ramadan (THYRAM): Basrah Experience.,"Background


Fasting the month of Ramadan should be achieved by every pubescent Muslim unless they have an excuse. Fasting involves complete abstinence of oral intake throughout daytime. Patients who have hypothyroidism usually require levothyroxine (L-thyroxine) replacement, which is typically given on an empty stomach away from meals. Taking L-thyroxine replacement without feeding is challenging during the nighttime of Ramadan, in addition to being prohibited during daytime.
Objectives


This study aimed to determine the best time of L-thyroxine intake during Ramadan.
Methods


Fifty patients who were taking L-thyroxine treatment for primary hypothyroidism were involved in this prospective study for three months including the fasting and pre-fasting months. The patients were divided into three groups with different times of L-thyroxine intake. In the group one (pre-iftar), the patients were asked to take L-thyroxine at the time of iftar (the sunset meal) but to delay any oral intake for at least 30 minutes. In the group two (post-iftar), the patients were asked to take L-thyroxine two hours after iftar. The patients in the last group (pre-suhoor) were asked not to eat in the last two hours before suhoor (the predawn meal) and to take L-thyroxine tablet one hour prior to suhoor.
Results


When thyroid stimulating hormone (TSH) levels were compared before and after Ramadan, there were no significant differences neither within each group nor among all the study groups. Moreover, the frequencies of the TSH control after Ramadan showed no significant differences within each of the study groups (P = 0.18, 0.75, 1.0 for pre-suhoor, pre-iftar, and post-iftar respectively). Similarly, comparison among the groups of the study showed no significant differences regardless of whether the patients had controlled or uncontrolled TSH prior to Ramadan (P = 0.75 and 0.67, respectively). In the patients with controlled TSH before Ramadan, 8 out of 10 (pre-suhoor), 8 out of 12 (pre-iftar), and 4 out of 6 (post-iftar) maintained their control after Ramadan. While in the patients with uncontrolled TSH before Ramadan, 7 out of 10 (pre-suhoor), 6 out of 8 (pre-iftar), and 2 out of 4 (post-iftar) achieved controlled TSH after Ramadan.
Conclusions


No significant differences in TSH control were observed in patients taking L-thyroxine at pre-iftar, post-iftar, or pre-suhoor time in Ramadan.",2020,"No significant differences in TSH control were observed in patients taking L-thyroxine at pre-iftar, post-iftar, or pre-suhoor time in Ramadan.","['Fifty patients who were taking L-thyroxine treatment for primary hypothyroidism', 'Patients who have hypothyroidism usually require levothyroxine (L-thyroxine) replacement, which is typically given on an empty stomach away from meals']","['THYRAM', 'Ramadan', 'L-thyroxine intake']","['TSH control', 'frequencies of the TSH control', 'thyroid stimulating hormone (TSH) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700502', 'cui_str': 'Acquired hypothyroidism'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.0141612,"No significant differences in TSH control were observed in patients taking L-thyroxine at pre-iftar, post-iftar, or pre-suhoor time in Ramadan.","[{'ForeName': 'Ibrahim Abbood', 'Initials': 'IA', 'LastName': 'Zaboon', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Haider Ayad', 'Initials': 'HA', 'LastName': 'Alidrisi', 'Affiliation': 'Department of Medicine, College of Medicine, University of Basrah, Basrah, Iraq.'}, {'ForeName': 'Ibrahim Hani', 'Initials': 'IH', 'LastName': 'Hussein', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Alabbood', 'Affiliation': 'Alzahraa College of Medicine, University of Basrah, Basrah, Iraq.'}, {'ForeName': 'Nassar Taha Yaseen', 'Initials': 'NTY', 'LastName': 'Alibrahim', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Ammar Mohammed Saeed', 'Initials': 'AMS', 'LastName': 'Almomin', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Dheyaa Kadhim', 'Initials': 'DK', 'LastName': 'Al-Waeli', 'Affiliation': 'Department of Medicine, College of Medicine, University of Thi-Qar, Thi-Qar, Iraq.'}, {'ForeName': 'Ali Hussein Ali', 'Initials': 'AHA', 'LastName': 'Alhamza', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Adel Gassab', 'Initials': 'AG', 'LastName': 'Mohammed', 'Affiliation': 'Thi-Qar Diabetic, Endocine, and Metabolism Center (TDEMC), Thi-Qar Health Directorate, Thi-Qar, Iraq.'}, {'ForeName': 'Hussein Ali', 'Initials': 'HA', 'LastName': 'Nwayyir', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Ahmed Jaafer Hindi', 'Initials': 'AJH', 'LastName': 'Al-Ali', 'Affiliation': 'Faiha Specialized Diabetes, Endocrine, and Metabolism Center (FDEMC), Basrah Health Directorate, Basrah, Iraq.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Mansour', 'Affiliation': 'Department of Medicine, College of Medicine, University of Basrah, Basrah, Iraq.'}]",International journal of endocrinology and metabolism,['10.5812/ijem.94325']
2288,32636891,Acute effects of equated volume-load resistance training leading to muscular failure versus non-failure on neuromuscular performance.,"Background/objective


The aim of this study was to compare the acute effects of resistance training to failure (TF) and non-failure (TNF) with volume-load equalization on neuromuscular performance in recreationally resistance-trained adults.
Methods


Twenty-two trained men (age 21.4 ± 2.3 years) were included in a controlled, randomized, and design cross-over investigation with two experimental conditions and one-week of washout interval between them. The participants performed parallel back-squat adopting TF or TNF with volume, intensity, and rest between sets equalized. Countermovement jump (CMJ) height and peak power (PP) were used as mechanical indicators of neuromuscular performance. The mechanical variables were assessed in five moments (pre-experiment, post 15-s, 10-min, 20-min, and 30-min).
Results


When compared with the TNF condition, TF presented greater decrement on CMJ height ( P  < 0.001) and PP ( P  < 0.001) performance. The CMJ height and PP performance in parallel back-squat exercise following the TNF condition returned to the pre-experiment values 10-min after ( P  > 0.05). On the other hand, the TF condition promoted greater decrement in CMJ and PP performance compared with the pre-experiment and TNF protocol even 20-30 min later ( P  < 0.05).
Conclusion


These findings suggest that TF promotes greater acute impairment on neuromuscular performance even when volume-load is equalized.",2020,The CMJ height and PP performance in parallel back-squat exercise following the TNF condition returned to the pre-experiment values 10-min after ( P  > 0.05).,"['recreationally resistance-trained adults', 'Methods\n\n\nTwenty-two trained men (age 21.4\xa0±\xa02.3 years']","['equated volume-load resistance training', 'TF', 'resistance training to failure (TF) and non-failure (TNF) with volume-load equalization']","['PP', 'CMJ and PP performance', 'CMJ height', 'Countermovement jump (CMJ) height and peak power (PP', 'CMJ height and PP performance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",22.0,0.0693019,The CMJ height and PP performance in parallel back-squat exercise following the TNF condition returned to the pre-experiment values 10-min after ( P  > 0.05).,"[{'ForeName': 'Fabiano S', 'Initials': 'FS', 'LastName': 'Fonseca', 'Affiliation': 'Department of Physical Education of Federal Rural University of Pernambuco, Brazil.'}, {'ForeName': 'Bruna Daniella de V', 'Initials': 'BDV', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education of State University of Londrina, Brazil.'}, {'ForeName': 'Maria Elisa C', 'Initials': 'MEC', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Education of Federal University of Juiz de Fora, Brazil.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Paes', 'Affiliation': 'Department of Physical Education of Federal University of Juiz de Fora, Brazil.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'de Lima-Junior', 'Affiliation': 'Department of Physical Education of Federal University of Paraiba, Brazil.'}, {'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Department of Physical Education of State University of Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Department of Physical Education of State University of Londrina, Brazil.'}, {'ForeName': 'Petrus', 'Initials': 'P', 'LastName': 'Gantois', 'Affiliation': 'Department of Physical Education of Federal University of Paraiba, Brazil.'}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Department of Physical Education of Federal University of Paraiba, Brazil.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.01.004']
2289,32636892,Effects of different solutions consumed during exercise on cognitive function of male college soccer players.,"Background/Objectives: The present study aimed to investigate the effects of three solutions, i.e. carbohydrate-electrolyte-solution (CES), carbohydrate-electrolyte-protein-solution (CEPS), and placebo (PLA), on cognitive function of college soccer players.
Methods


Sixteen male college soccer players completed three main trials in a randomized cross-over study design. In each main trial, participants completed 90 min Loughborough Intermittent Shuttle Test (LIST) protocol and consumed one of three solutions. The cognitive function tests were performed; blood glucose and lactate concentrations, and several subjective measurements were also recorded in each trial.
Results


Compared with pre-exercise level, the accuracy of Rapid Visual Information Processing test (RVIPT) and the response time in Visual Search Test (VST, complex level) after LIST improved in CES and CEPS trials, but not in PLA trial. However, the accuracy of VST (complex level) decreased in both CES and CEPS trials, compared with PLA trial. CEPS consumption improved accuracy in VST (simple level), compared with CES consumption. Blood glucose concentrations were well maintained in CEPS trial, but not in CES and PLA trials.
Conclusion


It seems that both CES and CEPS consumption show certain benefits on some aspects of cognitive function in male college soccer players in Hong Kong. However, these effects may be specific to the cognitive domain tested.",2020,"Compared with pre-exercise level, the accuracy of Rapid Visual Information Processing test (RVIPT) and the response time in Visual Search Test (VST, complex level) after LIST improved in CES and CEPS trials, but not in PLA trial.","['Sixteen male college soccer players', 'male college soccer players in Hong Kong', 'college soccer players', 'male college soccer players']","['solutions consumed during exercise', 'CES and CEPS', 'carbohydrate-electrolyte-solution (CES), carbohydrate-electrolyte-protein-solution (CEPS), and placebo (PLA']","['Blood glucose concentrations', 'blood glucose and lactate concentrations, and several subjective measurements', 'cognitive function', 'accuracy of VST (complex level', 'accuracy of Rapid Visual Information Processing test (RVIPT) and the response time in Visual Search Test (VST, complex level']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.165641,"Compared with pre-exercise level, the accuracy of Rapid Visual Information Processing test (RVIPT) and the response time in Visual Search Test (VST, complex level) after LIST improved in CES and CEPS trials, but not in PLA trial.","[{'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Sun', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Department of Sport Science, Sport Health and Performance Enhancement (SHAPE) Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Chak-Fung Tse', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong SAR, China.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.06.003']
2290,32636943,Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial.,"Background


Fibromyalgia (FM) is characterized by chronic pain and fatigue, among other manifestations, thus advising interventions that do not aggravate these symptoms. The main purpose of this study is to analyse the effect of low-pressure hyperbaric oxygen therapy (HBOT) on induced fatigue, pain, endurance and functional capacity, physical performance and cortical excitability when compared with a physical exercise program in women with FM.
Methods


A total of 49 women with FM took part in this randomized controlled trial. They were randomly allocated to three groups: physical exercise group (PEG,  n  = 16), low-pressure hyperbaric oxygen therapy group (HBG,  n  = 17) and control group (CG,  n  = 16). Induced fatigue, perceived pain, pressure pain threshold, endurance and functional capacity, physical performance and cortical excitability were assessed. To analyse the effect of the interventions, two assessments, that is, pre and post intervention, were carried out. Analyses of the data were performed using two-way mixed multivariate analysis of variance.
Results


The perceived pain and induced fatigue significantly improved only in the HBG ( p  < 0.05) as opposed to PEG and CG. Pressure pain threshold, endurance and functional capacity, and physical performance significantly improved for both interventions ( p  < 0.05). The cortical excitability (measured with the resting motor threshold) did not improve in any of the treatments ( p  > 0.05).
Conclusions


Low-pressure HBOT and physical exercise improve pressure pain threshold, endurance and functional capacity, as well as physical performance. Induced fatigue and perceived pain at rest significantly improved only with low-pressure HBOT.
Trial registration


ClinicalTrials.gov identifier NCT03801109.",2020,"Pressure pain threshold, endurance and functional capacity, and physical performance significantly improved for both interventions ( p  < 0.05).","['women with fibromyalgia', 'women with FM.\nMethods\n\n\nA total of 49 women with FM took part']","['physical exercise program', 'physical exercise group (PEG,  n \u2009=\u200916), low-pressure hyperbaric oxygen therapy group (HBG,  n \u2009=\u200917) and control group (CG,  n \u2009=\u200916', 'Low-pressure HBOT and physical exercise', 'low-pressure hyperbaric oxygen therapy (HBOT', 'low-pressure hyperbaric oxygen treatment and physical exercise']","['pressure pain threshold, endurance and functional capacity', 'Pressure pain threshold, endurance and functional capacity, and physical performance', 'Induced fatigue and perceived pain', 'perceived pain and induced fatigue', 'cortical excitability', 'induced fatigue, pain, endurance and functional capacity, physical performance and cortical excitability', 'Induced fatigue, perceived pain, pressure pain threshold, endurance and functional capacity, physical performance and cortical excitability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",49.0,0.202254,"Pressure pain threshold, endurance and functional capacity, and physical performance significantly improved for both interventions ( p  < 0.05).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Izquierdo-Alventosa', 'Affiliation': 'UBIC research group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Freshage Research Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, CIBERFES-ISCIII, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cortés-Amador', 'Affiliation': 'UBIC research group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Gimeno-Mallench', 'Affiliation': 'Freshage Research Group, Department of Physiology, Faculty of Medicine, University of Valencia, CIBERFES-ISCIII, INCLIVA, Valencia, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Sempere-Rubio', 'Affiliation': 'UBIC research group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Chirivella', 'Affiliation': 'FIVAN Foundation, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Department of Physiotherapy, UBIC research group, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, Valencia, 46010, Spain.'}]",Therapeutic advances in musculoskeletal disease,['10.1177/1759720X20930493']
2291,32636985,Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial.,"Objective:  Fifty-two subjects with chronic venous insufficiency and hard-to-heal lower leg ulceration (>1-year-old and >20-cm 2  surface area) were treated with either intermittent, gradient, pneumatic compression (n = 27) plus standard compression therapy or compression therapy alone (control).  Methods:  Compression therapy consisted of a nonadherent primary wound dressing plus a 4-layer compression bandage (n = 25). The mean age and size of the ulcers were 1.4 years and 31 cm 2 , respectively, and did not differ significantly between groups. Intermittent pneumatic compression was performed using a 4-chamber pneumatic leg sleeve and gradient, sequential pump. All pumps were calibrated to a pressure setting of 50 mm Hg on each subject, and treatments were for 1 hour twice daily. Evaluations were performed weekly to measure edema, local pain, granulation, and wound healing.  Results:  The median time to wound closure by 9 months was 141 days for the intermittent pneumatic compression-treated group and 211 days for the control group ( P  = .031). The rate of healing was 0.8 ± 0.4 mm/d for the control group and 2.1 ± 0.8 mm/d for the group treated with intermittent pneumatic compression ( P  < .05). When compared with subjects treated with standard care, the group treated with intermittent pneumatic compression reported less pain at each evaluation point for the first 6 weeks of the trial. At weeks 1, 2, and 3, the visual analog pain scores were significantly lower for the intermittent pneumatic compression-treated group ( P  < .05).  Conclusion:  These results suggest that intermittent pneumatic compression is a valuable adjunct to compression therapy in the management of large or painful venous ulcers.",2020,"At weeks 1, 2, and 3, the visual analog pain scores were significantly lower for the intermittent pneumatic compression-treated group ( P  < .05).  ",['Fifty-two subjects with chronic venous insufficiency and hard-to-heal lower leg ulceration (>1-year-old and >20-cm 2  surface area'],"['4-chamber pneumatic leg sleeve and gradient, sequential pump', 'Intermittent pneumatic compression', 'intermittent pneumatic compression', 'Intermittent Pneumatic Compression', 'intermittent, gradient, pneumatic compression (n = 27) plus standard compression therapy or compression therapy alone (control', 'Compression therapy', 'nonadherent primary wound dressing plus a 4-layer compression bandage']","['visual analog pain scores', 'edema, local pain, granulation, and wound healing', 'median time to wound closure', 'rate of healing', 'mean age and size of the ulcers', 'Faster Healing and a Lower Rate of Recurrence of Venous Ulcers', 'pain']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0677875', 'cui_str': 'Compression Bandage'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}]",52.0,0.0284218,"At weeks 1, 2, and 3, the visual analog pain scores were significantly lower for the intermittent pneumatic compression-treated group ( P  < .05).  ","[{'ForeName': 'Oscar M', 'Initials': 'OM', 'LastName': 'Alvarez', 'Affiliation': 'Vascular and Wound Care Center, University Hospital, Rutgers, New Jersey Medical School, Newark.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Markowitz', 'Affiliation': 'Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Wendelken', 'Affiliation': 'Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY.'}]",Eplasty,[]
2292,32637187,"Comparison of Dentoskeletal Changes, Esthetic, and Functional Efficacy of Conventional and Novel Esthetic Twin Block Appliances among Class II Growing Patients: A Pilot Study.","Objective


A twin block appliance used for correction of skeletal Class II malocclusion suffers from undesirable dental effects and bulkiness. To overcome these limitations and the need for more esthetic appearance of this appliance, an esthetic twin block was designed and used in patients. This study aimed to compare dentoskeletal changes and esthetic and functional efficacy in patients treated with conventional and newly designed esthetic twin block (CTB and ETB) appliances using cephalometric measurements and a questionnaire.
Methods


A pilot study with a 2-arm parallel-randomized double-blind clinical trial was conducted on 24 patients (20 males, 4 females) in the age group of 11-13 years. Subjects were treated with CTB (group 1 [G1]: n=12; mean age=11.67±0.49 years) and ETB (group 2 [G2]: n=12; mean age=11.75±0.62 years) appliances. A modified Pancherz analysis was performed to evaluate skeletal and dental changes. The esthetic and functional efficacy was evaluated by a questionnaire using Likert scale. Wilcoxon and Mann-Whitney U tests were employed for intra and intergroup comparisons respectively (p<0.05).
Results


In G1, a significant increase in lower incisor inclination was observed (p<0.05) whereas it was insignificant in G2. The changes were predominantly skeletal in G2 whereas they were both skeletal and dental in G1. ETB was found to be esthetically and functionally acceptable in all the patients while CTB patients were esthetically conscious, lacked confidence and had discomfort and difficulty in eating, chewing and speaking.
Conclusion


ETB had greater skeletal effects with a reduced tendency of lower incisor proclination, was esthetically acceptable, and functionally more comfortable than the CTB.",2020,"ETB was found to be esthetically and functionally acceptable in all the patients while CTB patients were esthetically conscious, lacked confidence and had discomfort and difficulty in eating, chewing and speaking.
","['Class II Growing Patients', 'n=12; mean age=11.75±0.62 years) appliances', 'patients treated with conventional and newly designed esthetic twin block (CTB and ETB) appliances using cephalometric measurements and a questionnaire', '24 patients (20 males, 4 females) in the age group of 11-13 years']","['Conventional and Novel Esthetic Twin Block Appliances', 'CTB', 'ETB']","['esthetic and functional efficacy', 'skeletal effects', 'ETB', 'dentoskeletal changes and esthetic and functional efficacy', 'lower incisor inclination', 'discomfort and difficulty in eating, chewing and speaking']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0111753', 'cui_str': 'Cytembena'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0111753', 'cui_str': 'Cytembena'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}]",24.0,0.0929161,"ETB was found to be esthetically and functionally acceptable in all the patients while CTB patients were esthetically conscious, lacked confidence and had discomfort and difficulty in eating, chewing and speaking.
","[{'ForeName': 'Tulika', 'Initials': 'T', 'LastName': 'Tripathi', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi, India.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi, India.'}, {'ForeName': 'Priyank', 'Initials': 'P', 'LastName': 'Rai', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi, India.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi, India.'}]",Turkish journal of orthodontics,['10.5152/TurkJOrthod.2020.19030']
2293,32637207,"Effect of intravenous lignocaine infusion on the quality of emergence in patients undergoing transsphenoidal resection of pituitary tumors - A prospective, randomized controlled trial.","Background


Emergence from anesthesia is a critical step in patients undergoing transsphenoidal pituitary surgery (TSS). The cough suppressant and anesthetic sparing properties of lignocaine makes it a favorable option for smooth extubation and maintaining stable hemodynamics intraoperatively. We aimed to evaluate the effect of lignocaine infusion on the quality of emergence (QOE) and intraoperative hemodynamics in patients undergoing transsphenoidal resection of pituitary tumors.
Methods


Fifty patients scheduled to undergo TSS were randomly divided into ligocaine group ( n  = 25), receiving 1.5 mg/kg bolus dose of lignocaine followed by continuous infusion of 1.5 mg/kg/h and saline group ( n  = 25). Patients assigned to the control group received equal volume of saline receiving equal volume of saline. The four emergence parameters (mean arterial pressure [MAP], heart rate (HR), cough, and agitation) were abbreviated into an aggregated score for QOE. Time to emergence and intraoperative hemodynamics were also recorded.
Results


The QOE was not found to be different between the two groups ( P  = 0.294). Lignocaine did not increase the time to emergence ( P  = 0.166). The intraoperative HR and MAP were comparable between the two groups. A lower minimum alveolar concentration of desflurane was required in lignocaine group during insertion of nasal speculum ( P  = 0.018) and at the time of seller ridge dissection ( P  = 0.043) compared to the saline group.
Conclusion


Intraoperative lignocaine infusion of 1.5 mg/kg/h did not significantly improve the QOE with respect to hemodynamics, cough, and emergence agitation in patients undergoing transsphenoidal resection of pituitary tumors.",2020,"A lower minimum alveolar concentration of desflurane was required in lignocaine group during insertion of nasal speculum ( P  = 0.018) and at the time of seller ridge dissection ( P  = 0.043) compared to the saline group.
","['patients undergoing transsphenoidal resection of pituitary tumors', 'patients undergoing transsphenoidal pituitary surgery (TSS', 'Fifty patients scheduled to undergo TSS']","['Lignocaine', 'lignocaine followed by continuous infusion of 1.5 mg/kg/h and saline', 'ligocaine', 'lignocaine', 'lignocaine infusion', 'control group received equal volume of saline receiving equal volume of saline']","['time to emergence', 'Time to emergence and intraoperative hemodynamics', 'intraoperative HR and MAP', 'arterial pressure [MAP], heart rate (HR), cough, and agitation', 'quality of emergence (QOE) and intraoperative hemodynamics', 'QOE', 'minimum alveolar concentration of desflurane', 'quality of emergence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032019', 'cui_str': 'Neoplasm of pituitary gland'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}]",50.0,0.0757968,"A lower minimum alveolar concentration of desflurane was required in lignocaine group during insertion of nasal speculum ( P  = 0.018) and at the time of seller ridge dissection ( P  = 0.043) compared to the saline group.
","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Surgical neurology international,['10.25259/SNI_576_2019']
2294,32637307,Evaluation of retrograde intubation with different doses of dexmedetomidine infusion: A randomised controlled trial.,"Background


Retrograde intubation is one of the well-described and alternative methods of difficult airway management. It requires effective sedation and patient preparation. Study was done to evaluate intubating conditions during retrograde guided intubation with two different doses of dexmedetomidine.
Methods


This prospective randomized double blind parallel group trial was planned on 60 patients with difficult airway. Patients were divided in two groups to receive either dexmedetomidine 1.0 μg/kg (Group A) or dexmedetomidine 1.5 μg/kg (Group B) by intravenous (IV) route. The Modified Observer Assessment Awareness and Sedation (OAA/S) was measured as primary outcome and ease of intubation, facial grimace score, cough severity, hemodynamic response, patient recall and discomfort were assessed as secondary outcome during awake retrograde intubation.
Results


Groups were comparable in terms of demographic and baseline parameters. OAA/S (P = 0.001), cough severity (P < 0.001), facial grimace score (P < 0.001), grading of discomfort during procedure (P < 0.001) and recall of procedure scale (P = 0.038) were found significantly better/lower in Group B as compared to Group A. Hemodynamic parameters were better in Group B and showed significant difference during the retrograde intubation. However, ease of intubation scale, intubating time and complications were not significantly different (P > 0.05) between the two groups.
Conclusion


Retrograde intubation can be easily learned and performed with minimal complications. Dexmedetomidine in a dose of 1.5 μg/kg IV is optimum and safe for retrograde intubation with clinically manageable side effects.",2020,"However, ease of intubation scale, intubating time and complications were not significantly different (P > 0.05) between the two groups.
",['60 patients with difficult airway'],"['Dexmedetomidine', 'Retrograde intubation', 'dexmedetomidine infusion', 'retrograde intubation', 'dexmedetomidine 1.0\xa0μg/kg (Group A) or dexmedetomidine', 'dexmedetomidine']","['grading of discomfort', 'Modified Observer Assessment Awareness and Sedation (OAA/S', 'facial grimace score', 'recall of procedure scale', 'ease of intubation, facial grimace score, cough severity, hemodynamic response, patient recall and discomfort', 'ease of intubation scale, intubating time and complications', 'cough severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1301699', 'cui_str': 'Retrograde intubation'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0234853', 'cui_str': 'Facial grimacing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",60.0,0.540054,"However, ease of intubation scale, intubating time and complications were not significantly different (P > 0.05) between the two groups.
","[{'ForeName': 'Tanmay', 'Initials': 'T', 'LastName': 'Tiwari', 'Affiliation': ""Department of Anesthesia and critical care, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Walian', 'Affiliation': 'Department of Cardiac Anesthesia, Atal Bihari Vajpayee Institute of Medical Sciences, RML Hospital, New Delhi, India.'}, {'ForeName': 'Vipin Kumar', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': ""Department of Anesthesia and critical care, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ""Department of Anesthesia and critical care, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': ""Department of Anesthesia and critical care, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Rawat', 'Affiliation': ""Department of Anesthesia and critical care, King George's Medical University, Lucknow, India.""}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.06.002']
2295,32637315,"Transcendental Meditation for women affected by domestic violence: Study protocol of a pilot randomised, controlled trial.","Background


Almost one in three women worldwide will be exposed to domestic and family violence some time in their life. This violence can contribute to physical, social, economic and psychological harm. Transcendental Meditation® (TM) may help to lessen the physical and emotional burden of domestic violence.
Methods


The objective of this pilot, parallel-group, randomized controlled trial is to compare the effectiveness of TM to support group control, on quality-of-life, perceived stress and mood in women affected by domestic violence. Women living in Adelaide, South Australia, who have experienced domestic violence in their lifetime, will be randomized to eight weeks of standardised TM training or facilitated group support sessions. Health-related quality of life (AQoL-8D), severity of depression, anxiety and perceived stress (DASS-21), and symptoms of post-traumatic stress disorder (PCL-5) will be self-reported by women at baseline, week 8 (post-intervention) and week 16 (follow-up). Data will be analysed by intention-to-treat using linear mixed-effects models.
Discussion


TM is an effortless, easily practiced and convenient relaxation technique, with reportedly high rates of adherence. While previous studies have shown TM to be effective in improving a range of psychological and behavioural outcomes across different populations, the effects of TM in survivors of domestic violence is largely unknown. If the study described herein is able to demonstrate the benefits of TM in this population, it might offer survivors an accessible, long-term and potentially cost-effective treatment option for domestic violence-induced distress, anxiety and depression. Trial registration : ACTRN12620000467932.",2020,"Health-related quality of life (AQoL-8D), severity of depression, anxiety and perceived stress (DASS-21), and symptoms of post-traumatic stress disorder (PCL-5) will be self-reported by women at baseline, week 8 (post-intervention) and week 16 (follow-up).","['women affected by domestic violence', 'Women living in Adelaide, South Australia, who have experienced domestic violence in their lifetime']","['TM', 'Transcendental Meditation', 'Transcendental Meditation® (TM']","['quality-of-life, perceived stress and mood', 'Health-related quality of life (AQoL-8D), severity of depression, anxiety and perceived stress (DASS-21), and symptoms of post-traumatic stress disorder (PCL-5']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0206073', 'cui_str': 'Domestic violence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0150814', 'cui_str': 'Transcendental meditation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}]",,0.142375,"Health-related quality of life (AQoL-8D), severity of depression, anxiety and perceived stress (DASS-21), and symptoms of post-traumatic stress disorder (PCL-5) will be self-reported by women at baseline, week 8 (post-intervention) and week 16 (follow-up).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Leach', 'Affiliation': 'National Centre for Naturopathic Medicine, Southern Cross University, East Lismore, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lorenzon', 'Affiliation': 'GMDO Ltd Australia, Hackham West, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Nidich', 'Affiliation': 'Center for Social-Emotional Health and Consciousness, Maharishi International University, Fairfield, USA.'}]",Integrative medicine research,['10.1016/j.imr.2020.100432']
2296,32637465,Developing a lung nodule management protocol specifically for cardiac CT: Methodology in the DISCHARGE trial.,"Purpose


In this methodology paper we describe the development of a lung nodule management algorithm specifically for patients undergoing cardiac CT.
Methods


We modified the Lung-RADS algorithm specifically to manage lung nodules incidentally detected on cardiac CT (Lung-RADS for cardiac CT). We will evaluate the modified algorithm as part of the DISCHARGE trial (www.dischargetrial.eu) in which patients with suspected coronary artery disease are randomly assigned to cardiac CT or invasive coronary angiography across Europe at 16 sites involving 3546 patients. Patients will be followed for up to four years.
Results


The major adjustments to Lung-RADS specifically for cardiac CT relate to 1) incomplete coverage of the lungs by cardiac CT compared with chest CT, and when to order a completion chest CT versus a follow up chest CT, 2) cardiac CT findings will not trigger annual lung-cancer screening, and 3) a lower threshold of at least 10 mm for classifying new ground glass nodules as probably benign (category 3).
Conclusions


The DISCHARGE trial will assess a lung nodule management algorithm designed specifically for cardiac CT in patients with stable chest pain across Europe.",2020,The DISCHARGE trial will assess a lung nodule management algorithm designed specifically for cardiac CT in patients with stable chest pain across Europe.,"['patients undergoing cardiac CT', 'patients with stable chest pain across Europe', 'across Europe at 16 sites involving 3546 patients', 'patients with suspected coronary artery disease']",['cardiac CT or invasive coronary angiography'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]",[],3546.0,0.0320183,The DISCHARGE trial will assess a lung nodule management algorithm designed specifically for cardiac CT in patients with stable chest pain across Europe.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haase', 'Affiliation': 'Department of Radiology, Charité University Hospital, Chariteplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Dodd', 'Affiliation': ""Department of Radiology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland.""}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Ella A', 'Initials': 'EA', 'LastName': 'Kazerooni', 'Affiliation': 'Michigan Medicine - University of Michigan Medical School, Departments of Radiology & Internal Medicine, 1500 E. Medical Center Dr, RM 5482 Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité University Hospital, Chariteplatz 1, 10117, Berlin, Germany.'}]",European journal of radiology open,['10.1016/j.ejro.2020.100235']
2297,32637463,The Effects of a Multicomponent Lower Extremity Training Technique on Physical Function in Healthy Older Adults: A Randomized Controlled Trial.,"Objective:  We aimed to examine the outcomes of our novel multicomponent lower extremity training (MLT) technique on physical function in older adults.  Methods:  Participants were randomly divided into a training group (TG) or a control group (CG). The TG (4 men, 14 women) received MLT for 24 weeks, once per week. MLT contains strength, balance, and flexibility components. The CG (5 men, 10 women) did not receive any training for 24 weeks. Nine lower extremity range of motions (ROMs; hip flexion, hip abduction, hip adduction, hip extension, internal and external hip rotations, knee flexion, ankle dorsiflexion, and ankle plantar flexion) and two muscle strength assessments (knee extension and flexion) were collected. Physical performance tests were also performed, including the functional reach test, timed up and go test (TUGT), and five times sit-to-stand test (FTSST).  Results:  After 24 weeks, significant increases were observed in the TG in all ROMs (with the exception of knee flexion), knee extension strength, and performance in the TUGT and FTSST.  Conclusions:  MLT significantly improved ROM, muscle strength, and physical performance in healthy older adults. We suggest that it is an efficacious intervention in the maintenance and improvement of mobility and functional independence in healthy older adults.  Trial registration:  UMIN CTR, UMIN000037463. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041955.",2020,"After 24 weeks, significant increases were observed in the TG in all ROMs (with the exception of knee flexion), knee extension strength, and performance in the TUGT and FTSST.  ","['healthy older adults', 'Healthy Older Adults', 'older adults']","['Multicomponent Lower Extremity Training Technique', 'MLT', 'novel multicomponent lower extremity training (MLT) technique', 'training group (TG) or a control group (CG']","['extremity range of motions (ROMs; hip flexion, hip abduction, hip adduction, hip extension, internal and external hip rotations, knee flexion, ankle dorsiflexion, and ankle plantar flexion) and two muscle strength assessments (knee extension and flexion', 'mobility and functional independence', 'MLT contains strength, balance, and flexibility components', 'Physical Function', 'TG in all ROMs', 'functional reach test, timed up and go test (TUGT), and five times sit-to-stand test (FTSST', 'ROM, muscle strength, and physical performance', 'knee flexion), knee extension strength, and performance in the TUGT and FTSST']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0024653', 'cui_str': 'Malta'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024653', 'cui_str': 'Malta'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",,0.0324087,"After 24 weeks, significant increases were observed in the TG in all ROMs (with the exception of knee flexion), knee extension strength, and performance in the TUGT and FTSST.  ","[{'ForeName': 'Hungu', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Hiroshima University, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Miki', 'Affiliation': 'Hiroshima Shudo University, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Hiroshima University, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Hiroshima Bunka Gakuen University, Japan.'}]",Gerontology & geriatric medicine,['10.1177/2333721420935702']
2298,32637558,Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.,"Aims


Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia.
Methods


The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use.
Conclusions


The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.",2020,The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA.,"['persons with HIV in Zambia', 'persons living with HIV (PLWH) in sub-Saharan Africa (SSA', '160 PLWH who meet criteria for unhealthy alcohol use\xa0+\xa0mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible', 'urban Zambia', 'HIV treatment centers in Lusaka']","['ZCAP', 'alcohol intervention (BI) based on CETA', 'CETA', 'single-session BI or CETA', 'evidence-based transdiagnostic multi-session psychotherapy']","['unhealthy alcohol use, depression, trauma symptoms, and other substance use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",160.0,0.0851707,The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA.,"[{'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Columbia University Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tukiya', 'Initials': 'T', 'LastName': 'Kanguya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Lasater', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'University of Zambia, School of Medicine, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mayeya', 'Affiliation': 'Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jenala', 'Initials': 'J', 'LastName': 'Chipungu', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chipo', 'Initials': 'C', 'LastName': 'Chitambi', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vinikoor', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}]",Addictive behaviors reports,['10.1016/j.abrep.2020.100278']
2299,32637616,"In some professions, women have become well represented, yet gender bias persists-Perpetuated by those who think it is not happening.","In efforts to promote equality and combat gender bias, traditionally male-occupied professions are investing resources into hiring more women. Looking forward, if women do become well represented in a profession, does this mean equality has been achieved? Are issues of bias resolved? Two studies including a randomized double-blind experiment demonstrate that biases persist even when women become well represented (evinced in veterinary medicine). Evidence included managers evaluating an employee randomly assigned a male (versus female) name as more competent and advising a $3475.00 higher salary, equating to an 8% pay gap. Importantly, those who thought bias was not happening in their field were the key drivers of it-a ""high risk"" group (including men and women) that, as shown, can be readily identified/assessed. Thus, as other professions make gains in women's representation, it is vital to recognize that discrimination can persist-perpetuated by those who think it is not happening.",2020,"In efforts to promote equality and combat gender bias, traditionally male-occupied professions are investing resources into hiring more women.","['Evidence included managers evaluating an employee randomly assigned a male (versus female) name as more competent and advising a $3475.00 higher salary, equating to an 8% pay gap']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036064', 'cui_str': 'Salaries'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]",[],[],,0.114038,"In efforts to promote equality and combat gender bias, traditionally male-occupied professions are investing resources into hiring more women.","[{'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Begeny', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, England, UK.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Ryan', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, England, UK.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Moss-Racusin', 'Affiliation': 'Department of Psychology, Skidmore College, Saratoga Springs, New York, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ravetz', 'Affiliation': 'British Veterinary Association, London, England, UK.'}]",Science advances,['10.1126/sciadv.aba7814']
2300,32637624,Formalizing land rights can reduce forest loss: Experimental evidence from Benin.,"Many countries are formalizing customary land rights systems with the aim of improving agricultural productivity and facilitating community forest management. This paper evaluates the impact on tree cover loss of the first randomized control trial of such a program. Around 70,000 landholdings were demarcated and registered in randomly chosen villages in Benin, a country with a high rate of deforestation driven by demand for agricultural land. We estimate that the program reduced the area of forest loss in treated villages, with no evidence of anticipatory deforestation or negative spillovers to other areas. Surveys indicate that possible mechanisms include an increase in tenure security and an improvement in the effectiveness of community forest management. Overall, our results suggest that formalizing customary land rights in rural areas can be an effective way to reduce forest loss while improving agricultural investments.",2020,"We estimate that the program reduced the area of forest loss in treated villages, with no evidence of anticipatory deforestation or negative spillovers to other areas.","['Around 70,000 landholdings were demarcated and registered in randomly chosen villages in Benin, a country with a high rate of deforestation driven by demand for agricultural land']",[],['tenure security'],"[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079201', 'cui_str': 'Deforestation'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]",[],[],70000.0,0.0226351,"We estimate that the program reduced the area of forest loss in treated villages, with no evidence of anticipatory deforestation or negative spillovers to other areas.","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Wren-Lewis', 'Affiliation': 'Paris School of Economics, 48 Boulevard Jourdan, Paris 75014, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Becerra-Valbuena', 'Affiliation': 'Paris School of Economics, 48 Boulevard Jourdan, Paris 75014, France.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Houngbedji', 'Affiliation': ""DIAL, LEDa, Université Paris-Dauphine, IRD, Université PSL, 4 Rue d'Enghien, Paris 75010, France.""}]",Science advances,['10.1126/sciadv.abb6914']
2301,32637656,Erratum: Author Correction: A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,2020,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,['Erratum'],['digital interventions'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0624127,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eilert', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'HEDS, ScHARR, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Jell', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sollesse', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}]",NPJ digital medicine,['10.1038/s41746-020-0298-3']
2302,32642474,Web-based intervention on the promotion of physical activity among Iranian youth using the transtheoretical model.,"BACKGROUND


Sedentary habits may increase the noncommunicable disease risk factors, and few teens get enough physical activity. Therefore, the current study aimed to examine the effects of a web-based intervention on the promotion of physical activity among adolescents using the transtheoretical model (TTM).
METHODS AND MATERIALS


A quasi-experimental study was conducted on 278 high school students who were randomly allocated into one of the three groups: two web-based intervention groups. The intervention groups 1 and 2 received education through web (www.salamat.family), but the second group received educational strategies based on TTM. Five questionnaires were applied two times before the intervention and 6 months after the intervention. And, in the control group, the data were collected using stage of exercise behavior change questionnaire and the International Physical Activity Questionnaire. Student's  t -test and two-way analysis of variance, and McNemar's test were applied to compare before and after the intervention.  P  < 0.05 was considered statistically significant.
RESULTS


The mean differences for TTM constructs related to exercise behaviors (processes of change, self-efficacy, and decisional balance) in intervention groups 1 and 2 were very higher than the control group. Participants in intervention groups 1 and 2 who had low or moderate physical activity before the intervention were placed in high physical activity after it.
CONCLUSION


According to the obtained results, education on PA based on website effective, but if we use education based on TTM, it will be more useful on the behavior.",2020,"According to the obtained results, education on PA based on website effective, but if we use education based on TTM, it will be more useful on the behavior.","['Iranian youth using the transtheoretical model', '278 high school students', 'adolescents using the transtheoretical model (TTM']","['education through web (www.salamat.family), but the second group received educational strategies based on TTM']","['exercise behavior change questionnaire and the International Physical Activity Questionnaire', 'exercise behaviors (processes of change, self-efficacy, and decisional balance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",278.0,0.014473,"According to the obtained results, education on PA based on website effective, but if we use education based on TTM, it will be more useful on the behavior.","[{'ForeName': 'Asiyeh', 'Initials': 'A', 'LastName': 'Pirzadeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Khoshali', 'Affiliation': 'Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_36_20']
2303,32642479,Effect of web-based and software-based educational intervention on stages of behavior change of students' physical activity.,"INTRODUCTION


The present study aims at designing and evaluating the effect of new educational media-based educational intervention on students' stages of behavior change of physical activity.
SUBJECTS AND METHODS


In the present interventional study, 225 students of medical sciences university were assigned into two experimental and one control groups using proportional stratified random sampling, where web-based and software-based educational interventions were used. Data were collected using International Physical Activity Questionnaire, Marcus's stages of change scales, and a self-made questionnaire including constructs of barriers, benefits, and self-efficacy. Evaluation was conducted through pretest and posttest and immediate and 2 and 6 months of follow-ups after the intervention. Data were analyzed by SPSS software using descriptive statistics and Chi-square, Friedman, one-way ANOVA, and ANOVA with repeated measure.
RESULTS


Based on the results, there was no significant difference between the experimental and control groups before the intervention ( P  = 0.37); however, immediately and 2 and 6 months after the intervention, there was a significant difference between the experimental and control groups in terms of stages of change ( P  < 0.001). Furthermore, in the experimental group, the educational intervention led to improvement of individuals in the stages of change of physical activity. At 6-month follow-up, 75.4% of the software group and 60.6% of the web group achieved the maintenance stage.
CONCLUSION


The results suggest that designing intervention based on people's level of preparation for changing behavior and using new educational methods such as web and software were effective on individuals' progress in different stages of change of physical activity behavior and physical activity rate.",2020,"Furthermore, in the experimental group, the educational intervention led to improvement of individuals in the stages of change of physical activity.","[""students' stages of behavior change of physical activity"", '225 students of medical sciences university', ""students' physical activity""]","['new educational media-based educational intervention', 'web-based and software-based educational intervention', 'educational intervention']","['physical activity behavior and physical activity rate', ""International Physical Activity Questionnaire, Marcus's stages of change scales, and a self-made questionnaire including constructs of barriers, benefits, and self-efficacy""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",225.0,0.0262318,"Furthermore, in the experimental group, the educational intervention led to improvement of individuals in the stages of change of physical activity.","[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Sabooteh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Shekarchizadeh', 'Affiliation': 'Department of General Courses, School of Management and Medical Information Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Mostafavi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_645_19']
2304,32642482,Endotracheal intubation training to medical practitioners: Comparison of the modified 4-step Payton's training method and Halsted's training method in a simulated environment.,"INTRODUCTION


The ability of physicians to perform endotracheal intubation by laryngoscope is one of the essential skills. The purpose of this study was to evaluate the effectiveness of the four-step python training method with the Halsted's ""See one, Do one, and Teach one"" training method in endotracheal intubation competency in simulated environment.
MATERIALS AND METHODS


This quasi-experimental study was performed on two independent groups with posttest. The statistical society consisted of eighth-semester medical students referred to the emergency medicine unit. The experimental group received a modified four-step python's training method that modified for small groups, and the control group received the Halsted's ""See one, Do one, and Teach one"" training method. Researcher-made checklist used to rate participant competency as posttest. Data were analyzed using SPSS 19 software.
RESULTS


Sixty-seven students volunteered for the experimental group and 57 students for the control group. In posttest, the experimental group more competent than the control group significantly ( P  < 0.001). Furthermore, the training course satisfaction of the experimental group was significantly higher than the control group ( P  < 0.001).
DISCUSSION AND CONCLUSION


Modified python training method for small groups has shown a better effect on student performance. This finding is consistent with previous researches. Modified four-step python's training for small group with an emphasis on peer to peer teaching and receiving feedback from peer can be related to the effectiveness of this training. Further research is recommended in other clinical education settings.",2020,"In posttest, the experimental group more competent than the control group significantly ( P  < 0.001).","['Sixty-seven students volunteered for the experimental group and 57 students for the control group', 'medical practitioners']","['Endotracheal intubation training', 'modified four-step python\'s training method that modified for small groups, and the control group received the Halsted\'s ""See one, Do one, and Teach one"" training method']",[],"[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0206304', 'cui_str': 'Genus Python'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],67.0,0.014853,"In posttest, the experimental group more competent than the control group significantly ( P  < 0.001).","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Zamani', 'Affiliation': 'Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Forghani', 'Affiliation': 'Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammadreza Asadollahian', 'Initials': 'MA', 'LastName': 'Sichani', 'Affiliation': 'Department of Emergency Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Athar', 'Initials': 'A', 'LastName': 'Omid', 'Affiliation': 'Department of Medical Education, Medical Education Development Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_705_19']
2305,32642485,Impact of counseling and reinforcement by school teachers on behavior change in children: A one -year follow-up study.,"INTRODUCTION


School teachers play an important role in instilling positive behavior changes among school children. School children at an early age group of 2-7 years face challenges and need extra support. Utilization of psychological interventions via school teachers for oral health promotion is minimal. The present study was done to determine the impact of counseling and reinforcement by school teachers on children for a follow-up period of 1 year.
MATERIALS AND METHODS


A quantitative research on 58 randomly selected children for a follow-up of one year was conducted to determine the prevalence of preoperational characteristics in school children. The tools to determine characters in preoperational children consisted of classical cognitive experiments followed by behavior counseling intervention. The interventional group received reinforcement with school teachers for a follow-up of one year.
RESULTS


The assessment of the three characteristics revealed a prevalence of ego centralism, centration, and lack of conservation and reversibility in 84.4%, 89.6%, and 89.6% children, respectively. A significant difference in behavior change was seen in children who received behavior counseling and reinforcement.
CONCLUSION


The present study concluded that Piaget's characteristics were consistent for a follow-up period of one year.",2020,"A significant difference in behavior change was seen in children who received behavior counseling and reinforcement.
","['school children', 'children', 'school teachers on children for a follow-up period of 1 year', '58 randomly selected children for a follow-up of one year', 'School children at an early age group of 2-7 years face challenges and need extra support']","['classical cognitive experiments followed by behavior counseling intervention', 'counseling and reinforcement by school teachers', 'reinforcement with school teachers']","['behavior change', 'prevalence of ego centralism, centration, and lack of conservation and reversibility']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}]",58.0,0.0199497,"A significant difference in behavior change was seen in children who received behavior counseling and reinforcement.
","[{'ForeName': 'Upendra Singh', 'Initials': 'US', 'LastName': 'Bhadauria', 'Affiliation': 'Research Officer, National Oral Health Program, Center for Dental Education and Research, AIIMS, New Delhi, India.'}, {'ForeName': 'Rouble Verma', 'Initials': 'RV', 'LastName': 'Mathur', 'Affiliation': 'Independent Researcher, Department of Oral and Maxillofacial Surgery, Indore, India.'}, {'ForeName': 'Aanchal', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Independent Researcher, Department of Oral and Maxillofacial Surgery, Indore, India.'}, {'ForeName': 'Rishabh', 'Initials': 'R', 'LastName': 'Shukla', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Indore, India.'}, {'ForeName': 'Shaijal', 'Initials': 'S', 'LastName': 'Godha', 'Affiliation': 'Independent Researcher, Department of Oral and Maxillofacial Surgery, Indore, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Assistant Professor, Department of Orthodontics and Dentofacial Orthopaedics, Sri Aurobindo College of Dentistry, Indore, Madhya Pradesh, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_84_20']
2306,32642594,The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial.,"Nearly all individuals with Down Syndrome (DS) display pathology associated with Alzheimer's disease (AD) beginning as early as age 30. Previous research in typically developed adults suggests that increased moderate-to-vigorous physical activity (MVPA) may improve cognitive function and protect against age-related structural and functional changes in the brain; however, the potential impact of increased MVPA on the development of AD in adults with DS has not been evaluated. Despite the potential positive impact of MVPA on cognition and AD risk, participation in MVPA among young adults with DS is low. The limited research evaluating strategies for increasing MVPA in adults with DS has been unsuccessful in increasing MVPA. Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function. However, the sustainability, impact on total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health of remotely delivered group MVPA sessions in adults with DS are unknown. Therefore, we will conduct a trial in 80 non-demented adults with DS to determine the feasibility and potential efficacy of remotely delivered group MVPA sessions to increase daily MVPA, relative to a usual care control. Secondarily we will assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD.
NCT registration


NCT04048759.",2020,"Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function.","['young adults with DS', ""Nearly all individuals with Down Syndrome (DS) display pathology associated with Alzheimer's disease (AD) beginning as early as age 30"", '80 non-demented adults with DS', 'adults with DS', 'adults with Down Syndrome']","['MVPA', 'MVPA sessions']","['cognition and AD risk, participation in MVPA', 'total daily MVPA, optimal session frequency, and potential impacts on cognitive function and brain health', 'cognitive function', 'cardiovascular fitness, quality of life, cognitive function and brain parameters related to AD']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",80.0,0.0408096,"Results from our preliminary investigation where we remotely delivered real-time MVPA, led by a trained health educator, to groups of adults with DS in their homes via video conferencing on a tablet computer demonstrated high attendance, increased MVPA during group sessions, and improvements in cognitive function.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Lepping', 'Affiliation': 'Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Phill', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forsha', 'Affiliation': ""Ward Family Heart Center, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Danon', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100607']
2307,32642655,Conventional MRI radiomics in patients with suspected early- or pseudo-progression.,"Background


After radiochemotherapy, 30% of patients with early worsening MRI experience pseudoprogression (Psp) which is not distinguishable from early progression (EP). We aimed to assess the diagnostic value of radiomics in patients with suspected EP or Psp.
Methods


Radiomics features (RF) of 76 patients (53 EP and 23 Psp) retrospectively identified were extracted from conventional MRI based on four volumes-of-interest. Subjects were randomly assigned into training and validation groups. Classification model (EP versus Psp) consisted of a random forest algorithm after univariate filtering. Overall (OS) and progression-free survivals (PFS) were predicted using a semi-supervised principal component analysis, and forecasts were evaluated using C-index and integrated Brier scores (IBS).
Results


Using 11 RFs, radiomics classified patients with 75.0% and 76.0% accuracy, 81.6% and 94.1% sensitivity, 50.0% and 37.5% specificity, respectively, in training and validation phases. Addition of  MGMT  promoter status improved accuracy to 83% and 79.2%, and specificity to 63.6% and 75%. OS model included 14 RFs and stratified low- and high-risk patients both in the training (hazard ratio [HR], 3.63;  P  = .002) and the validation (HR, 3.76;  P  = .001) phases. Similarly, PFS model stratified patients during training (HR, 2.58;  P  = .005) and validation (HR, 3.58;  P  = .004) phases using 5 RF. OS and PFS forecasts had C-index of 0.65 and 0.69, and IBS of 0.122 and 0.147, respectively.
Conclusions


Conventional MRI radiomics has promising diagnostic value, especially when combined with  MGMT  promoter status, but with moderate specificity. In addition, our results suggest a potential for predicting OS and PFS.",2019,"Overall (OS) and progression-free survivals (PFS) were predicted using a semi-supervised principal component analysis, and forecasts were evaluated using C-index and integrated Brier scores (IBS).
","['76 patients (53 EP and 23 Psp) retrospectively identified were extracted from conventional MRI based on four volumes-of-interest', 'patients with suspected early- or pseudo-progression', 'patients with suspected EP or Psp']","['radiochemotherapy', 'Conventional MRI radiomics']",['Overall (OS) and progression-free survivals (PFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205237', 'cui_str': 'False'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",14.0,0.0338275,"Overall (OS) and progression-free survivals (PFS) were predicted using a semi-supervised principal component analysis, and forecasts were evaluated using C-index and integrated Brier scores (IBS).
","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bani-Sadr', 'Affiliation': 'Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Eker', 'Affiliation': 'Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Lise-Prune', 'Initials': 'LP', 'LastName': 'Berner', 'Affiliation': 'Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Ameli', 'Affiliation': 'Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hermier', 'Affiliation': 'Department of Neuroradiology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Barritault', 'Affiliation': 'Department of Molecular Biology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meyronet', 'Affiliation': 'Department of Neuropathology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Guyotat', 'Affiliation': 'Department of Neurosurgery, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Jouanneau', 'Affiliation': 'Department of Neurosurgery, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Honnorat', 'Affiliation': 'Université Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Ducray', 'Affiliation': 'Université Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Berthezene', 'Affiliation': 'Université Claude Bernard Lyon 1, Villeurbanne, France.'}]",Neuro-oncology advances,['10.1093/noajnl/vdz019']
2308,32642669,A phase III double-blind placebo-controlled randomized study of dexamphetamine sulfate for fatigue in primary brain tumors patients: An ANOCEF trial (DXA).,"Background


Most patients suffering from a primary brain tumor (PBT) complain of chronic fatigue affecting their quality of life (QOL). We hypothesized that dexamphetamine sulfate, a psychostimulant drug, could improve fatigue in PBT patients.
Methods


A double-blind, phase III, multi-institutional, placebo-controlled randomized trial (1:1 allocation) assessed the efficacy and tolerability of dexamphetamine at a dosage of 30 mg/day in PBT patients with stable disease who complained of severe fatigue, defined as a Multidimensional Fatigue Inventory (MFI-20) score ≥60. The primary outcome was the variation of the MFI 20 score between inclusion and the evaluation at 3 months in nonprogressive patients. Mood, QOL and cognitive function were also evaluated.
Results


From April 2013 to November 2016, 46 patients were enrolled in the study, 41 of whom were evaluable for analysis (dexamphetamine group: 22; placebo group: 19). Tolerance was generally good, with no treatment-related deaths and no grade 4 toxicity. Patients in the dexamphetamine arm complained more frequently of psychiatric side effects (mostly hyperactivity, anxiety, sleep disorder, and irritability) than patients in the placebo arm ( P  = .018). There were no statistically significant differences at 3 months between the dexamphetamine and placebo arms in any of the outcomes (MFI-20, Norris Visual Analog Scale, Hospital Anxiety and Depression Scale (HADS), QOL (EORTC QLQ-C30/BN 20), Marin's Apathy Evaluation Scale, and cognitive evaluations).
Conclusion


Dexamphetamine at a dosage of up to 30 mg/day for 3 months has acceptable tolerability in PBT patients but does not improve fatigue, cognitive function, or QOL.",2019,"There were no statistically significant differences at 3 months between the dexamphetamine and placebo arms in any of the outcomes (MFI-20, Norris Visual Analog Scale, Hospital Anxiety and Depression Scale (HADS), QOL (EORTC QLQ-C30/BN 20), Marin's Apathy Evaluation Scale, and cognitive evaluations).
","['primary brain tumors patients', 'PBT patients', 'PBT patients with stable disease who complained of severe fatigue, defined as a Multidimensional Fatigue Inventory (MFI-20) score ≥60', 'patients suffering from a primary brain tumor (PBT) complain of chronic fatigue affecting their quality of life (QOL', '46 patients were enrolled in the study, 41 of whom were evaluable for analysis (dexamphetamine group: 22; placebo group: 19', 'Results\n\n\nFrom April 2013 to November 2016']","['dexamphetamine sulfate', 'dexamphetamine and placebo', 'Dexamphetamine', 'dexamphetamine', 'placebo']","[""outcomes (MFI-20, Norris Visual Analog Scale, Hospital Anxiety and Depression Scale (HADS), QOL (EORTC QLQ-C30/BN 20), Marin's Apathy Evaluation Scale, and cognitive evaluations"", 'efficacy and tolerability', 'variation of the MFI 20 score', 'deaths and no grade 4 toxicity', 'Tolerance', 'psychiatric side effects (mostly hyperactivity, anxiety, sleep disorder, and irritability', 'Mood, QOL and cognitive function', 'fatigue, cognitive function, or QOL']","[{'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0011810', 'cui_str': 'Dextroamphetamine sulfate'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",46.0,0.391399,"There were no statistically significant differences at 3 months between the dexamphetamine and placebo arms in any of the outcomes (MFI-20, Norris Visual Analog Scale, Hospital Anxiety and Depression Scale (HADS), QOL (EORTC QLQ-C30/BN 20), Marin's Apathy Evaluation Scale, and cognitive evaluations).
","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Laigle-Donadey', 'Affiliation': 'AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Ducray', 'Affiliation': 'Hospices Civils de Lyon, Groupe Hospitalier Est, Service de Neuro-Oncologie, Lyon, Cedex, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boone', 'Affiliation': ""Service d'Oncologie Médicale, CHU Amiens-Picardie, Chimère, France.""}, {'ForeName': 'Mamadou Hassimiou', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière Charles Foix, Unité de Recherche Clinique, Paris, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Paris, France.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Ramirez', 'Affiliation': 'Service de Neurochirurgie, Hôpital Roger Salengro, CHRU de Lille, rue Emile Laine, Cedex, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Ricard', 'Affiliation': ""Hôpital d'Instruction des Armées Percy, Service de Santé des Armées, Clamart, France.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Delattre', 'Affiliation': 'AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin; Sorbonne Université, UPMC Univ Paris 06, UMR S 1127; INSERM, U 1127; CNRS, UMR 7225; ICM, Paris, France.'}]",Neuro-oncology advances,['10.1093/noajnl/vdz043']
2309,32642699,Hydroxychloroquine and short-course radiotherapy in elderly patients with newly diagnosed high-grade glioma: a randomized phase II trial.,"Background


Effective treatment for patients at least 70 years with newly diagnosed glioblastoma remains challenging and alternatives to conventional cytotoxics are appealing. Autophagy inhibition has shown promising efficacy and safety in small studies of glioblastoma and other cancers.
Methods


We conducted a randomized phase II trial to compare radiotherapy with or without hydroxychloroquine (2:1 allocation). Patients aged at least 70 years with newly diagnosed high-grade glioma deemed suitable for short-course radiotherapy with an ECOG performance status of 0-1 were included. Radiotherapy treatment consisted of 30 Gy, delivered as 6 fractions given over 2 weeks (5 Gy per fraction). Hydroxychloroquine was given as 200 mg orally b.d. from 7 days prior to radiotherapy until disease progression. The primary endpoint was 1-year overall survival (OS). Secondary endpoints included progression-free survival (PFS), quality of life, and toxicity.
Results


Fifty-four patients with a median age of 75 were randomized between May 2013 and October 2016. The trial was stopped early in 2016. One-year OS was 20.3% (95% confidence interval [CI] 8.2-36.0) hydroxychloroquine group, and 41.2% (95% CI 18.6-62.6) radiotherapy alone, with a median survival of 7.9 and 11.5 months, respectively. The corresponding 6-month PFS was 35.3% (95% CI 19.3-51.7) and 29.4% (95% CI 10.7-51.1). The outcome in the control arm was better than expected and the excess of deaths in the hydroxychloroquine group appeared unrelated to cancer. There were more grade 3-5 events in the hydroxychloroquine group (60.0%) versus radiotherapy alone (38.9%) without any clear common causation.
Conclusions


Hydroxychloroquine with short-course radiotherapy did not improve survival compared to radiotherapy alone in elderly patients with glioblastoma.",2020,"There were more grade 3-5 events in the hydroxychloroquine group (60.0%) versus radiotherapy alone (38.9%) without any clear common causation.
","['Results\n\n\nFifty-four patients with a median age of 75 were randomized between May 2013 and October 2016', 'elderly patients with newly diagnosed high-grade glioma', 'patients at least 70 years with newly diagnosed glioblastoma', 'elderly patients with glioblastoma', 'Patients aged at least 70 years with newly diagnosed high-grade glioma deemed suitable for short-course radiotherapy with an ECOG performance status of 0-1 were included']","['radiotherapy', 'hydroxychloroquine', 'Hydroxychloroquine', 'radiotherapy with or without hydroxychloroquine', 'Hydroxychloroquine and short-course radiotherapy', 'Hydroxychloroquine with short-course radiotherapy', 'Radiotherapy']","['1-year overall survival (OS', 'excess of deaths', 'median survival', 'survival', '6-month PFS', 'progression-free survival (PFS), quality of life, and toxicity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",54.0,0.329251,"There were more grade 3-5 events in the hydroxychloroquine group (60.0%) versus radiotherapy alone (38.9%) without any clear common causation.
","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brazil', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Swampillai', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ka Man', 'Initials': 'KM', 'LastName': 'Mak', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Pavlina', 'Initials': 'P', 'LastName': 'Mesiri', 'Affiliation': 'ClinBAY Ltd., Limassol, Cyprus.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shaffer', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital, Newcastle Upon Tyne Hospitals Trust, Newcastle, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'University of Birmingham/Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jeffries', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Pinelopi', 'Initials': 'P', 'LastName': 'Gkogkou', 'Affiliation': 'Norfolk and Norwich University Hospitals, Norwich, UK.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Chalmers', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naomi L', 'Initials': 'NL', 'LastName': 'Fersht', 'Affiliation': 'UCLH NHS Foundation Trust, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Short', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}]",Neuro-oncology advances,['10.1093/noajnl/vdaa046']
2310,32642719,EGFR mutations are associated with response to depatux-m in combination with temozolomide and result in a receptor that is hypersensitive to ligand.,"Background


The randomized phase II INTELLANCE-2/EORTC_1410 trial on EGFR-amplified recurrent glioblastomas showed a trend towards improved overall survival when patients were treated with depatux-m plus temozolomide compared with the control arm of alkylating chemotherapy only. We here performed translational research on material derived from this clinical trial to identify patients that benefit from this treatment.
Methods


Targeted DNA-sequencing and whole transcriptome analysis was performed on clinical trial samples. High-throughput, high-content imaging analysis was done to understand the molecular mechanism underlying the survival benefit.
Results


We first define the tumor genomic landscape in this well-annotated patient population. We find that tumors harboring EGFR single-nucleotide variations (SNVs) have improved outcome in the depatux-m + TMZ combination arm. Such SNVs are common to the extracellular domain of the receptor and functionally result in a receptor that is hypersensitive to low-affinity EGFR ligands. These hypersensitizing SNVs and the ligand-independent EGFRvIII variant are inversely correlated, indicating two distinct modes of evolution to increase EGFR signaling in glioblastomas. Ligand hypersensitivity can explain the therapeutic efficacy of depatux-m as increased ligand-induced activation will result in increased exposure of the epitope to the antibody-drug conjugate. We also identified tumors harboring mutations sensitive to ""classical"" EGFR tyrosine-kinase inhibitors, providing a potential alternative treatment strategy.
Conclusions


These data can help guide treatment for recurrent glioblastoma patients and increase our understanding into the molecular mechanisms underlying EGFR signaling in these tumors.",2020,We find that tumors harboring EGFR single-nucleotide variations (SNVs) have improved outcome in the depatux-m + TMZ combination arm.,['recurrent glioblastoma patients'],"['temozolomide', 'depatux-m plus temozolomide']",['overall survival'],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C4477221', 'cui_str': 'depatuxizumab mafodotin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0686622,We find that tumors harboring EGFR single-nucleotide variations (SNVs) have improved outcome in the depatux-m + TMZ combination arm.,"[{'ForeName': 'Youri', 'Initials': 'Y', 'LastName': 'Hoogstrate', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Wies', 'Initials': 'W', 'LastName': 'Vallentgoed', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Johan M', 'Initials': 'JM', 'LastName': 'Kros', 'Affiliation': 'Pathology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'de Heer', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Carlo Besta, Milano, Italy.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': '12 Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Annemiek M E', 'Initials': 'AME', 'LastName': 'Walenkamp', 'Affiliation': 'UMCG, Groningen, The Netherlands.'}, {'ForeName': 'Jean-Sebastien', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': 'Gauducheau, Nantes, France.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'AUSL/IRCCS Institute of Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Switzerland.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'van Royen', 'Affiliation': 'Pathology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'AbbVie, North Chicago, Illinois, Belgium.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': 'AbbVie, North Chicago, Illinois, Belgium.'}, {'ForeName': 'Earle', 'Initials': 'E', 'LastName': 'Bain', 'Affiliation': 'AbbVie, North Chicago, Illinois, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Morfouace', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Bent', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Pim J', 'Initials': 'PJ', 'LastName': 'French', 'Affiliation': 'Departments of Neurology, Erasmus MC, Rotterdam, The Netherlands.'}]",Neuro-oncology advances,['10.1093/noajnl/vdz051']
2311,32642971,Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes.,"PURPOSE


Soluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX ®  on glycemic control in adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program.
METHODS


In a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15-20 g/day) or isocaloric placebo (rice flour, 6.4-8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota.
RESULTS


Compared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia.
CONCLUSION


Adding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D.
CLINICAL TRIAL


This trial was registered at ClinicalTrials.gov as NCT01644201.",2020,"At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points.","['patients with T2D.\nCLINICAL TRIAL', 'adults with type 2 diabetes', 'adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program', '290 adults with overweight/obesity and T2D']","['soluble viscous fibre PGX ®', 'PGX', 'functional fibre supplement', 'isocaloric placebo', 'placebo']","['waist circumference', 'relative abundance of Collinsella, Parabacteroides and Roseburia', 'body weight', 'LDL cholesterol', 'change in glycemic control (HbA1c', 'weight loss, blood lipids, blood pressure, cytokines and fecal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1047126', 'cui_str': 'Collinsella'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",290.0,0.235919,"At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points.","[{'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada. reimer@ucalgary.ca.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'The Wharton Medical Clinic and Weight Management Centre, Hamilton, ON, Canada.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'Healthy Mothers, Babies, and Children, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Manjoo', 'Affiliation': 'Department of Medicine, Vancouver Island Health Authority, University of Victoria, University of British Columbia, Victoria, Canada.'}, {'ForeName': 'Hena R', 'Initials': 'HR', 'LastName': 'Ramay', 'Affiliation': 'International Microbiome Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Lyon', 'Affiliation': 'Obesity Medicine and Diabetes Institute, Coquitlam, BC, Canada.'}, {'ForeName': 'Roland J', 'Initials': 'RJ', 'LastName': 'Gahler', 'Affiliation': 'Factors Group of Nutritional Products Inc. R & D, Burnaby, BC, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'InovoBiologic Inc., Calgary, AB, Canada.'}]",European journal of nutrition,['10.1007/s00394-020-02328-8']
2312,32643012,Comparison of the proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA) in cardiac surgery patients susceptible to bleeding: a randomized controlled trial.,"BACKGROUND


The present study aimed at comparing the success rate and safety of proximal versus distal approach for ultrasound (US)-guided axillary vein catheterization (AVC) in cardiac surgery patients susceptible to bleeding.
METHODS


In this single-center randomized controlled trial, cardiac surgery patients susceptible to bleeding and requiring AVC were randomized to either the proximal or distal approach group for US-guided AVC. Patients susceptible to bleeding were defined as those who received oral antiplatelet drugs or anticoagulants for at least 3 days. Success rate, catheterization time, number of attempts, and mechanical complications within 24 h were recorded for each procedure.
RESULTS


A total of 198 patients underwent randomization: 99 patients each to the proximal and distal groups. The proximal group had the higher first puncture success rate (75.8% vs. 51.5%, p < 0.001) and site success rate (93.9% vs. 83.8%, p = 0.04) than the distal group. However, the overall success rates between the two groups were similar (99.0% vs. 99.0%; p = 1.00). Moreover, the proximal group had fewer average number of attempts (p < 0.01), less access time (p < 0.001), and less successful cannulation time (p < 0.001). There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
CONCLUSIONS


For cardiac surgery patients susceptible to bleeding, both proximal and distal approaches for US-guided AVC can be considered as feasible and safe methods of central venous cannulation. In terms of the first puncture success rate and cannulation time, the proximal approach is superior to the distal approach. Trial registration Clinicaltrials.gov, NCT03395691. Registered January 10, 2018, https://clinicaltrials.gov/ct2/show/NCT03395691?cond=NCT03395691&draw=1&rank=1 .",2020,"There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
","['cardiac surgery patients susceptible to bleeding and requiring AVC', '198 patients underwent randomization: 99 patients each to the proximal and distal groups', 'cardiac surgery patients susceptible to bleeding']","['proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA', 'proximal versus distal approach for ultrasound (US)-guided axillary vein catheterization (AVC', 'proximal or distal approach group for US-guided AVC']","['overall success rates', 'higher first puncture success rate', 'major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements', 'Success rate, catheterization time, number of attempts, and mechanical complications within 24\xa0h', 'complications', 'successful cannulation time', 'site success rate', 'access time']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0444454', 'cui_str': 'Access'}]",198.0,0.174438,"There was no significant difference in complications between the two groups, such as major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, and catheter misplacements.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Hou', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Guo-Guang', 'Initials': 'GG', 'LastName': 'Ma', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Guang-Wei', 'Initials': 'GW', 'LastName': 'Hao', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Jing-Chao', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Shen-Ji', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Ji-Li', 'Initials': 'JL', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Nursing, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China. luo.zhe@zs-hospital.sh.cn.'}, {'ForeName': 'Guo-Wei', 'Initials': 'GW', 'LastName': 'Tu', 'Affiliation': 'Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China. tu.guowei@zs-hospital.sh.cn.'}]",Annals of intensive care,['10.1186/s13613-020-00703-6']
2313,32643163,Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials.,"OBJECTIVE


To analyze the effects of a standardized community health worker (CHW) intervention on hospitalization.
DATA SOURCES/STUDY SETTING


Pooled data from three randomized clinical trials (n = 1340) conducted between 2011 and 2016.
STUDY DESIGN


The trials in this pooled analysis were conducted across diseases and settings, with a common study design, intervention, and outcome measures. Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured. They were randomly assigned to receive usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation. Trial one (n = 446) tested two weeks of IMPaCT among hospitalized general medical patients. Trial two (n = 302) tested six months of IMPaCT among outpatients at two academic primary care clinics. Trial three (n = 592) tested six months of IMPaCT among outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices.
DATA COLLECTION/EXTRACTION METHODS


The primary outcome for this study was all-cause hospitalization, as measured by total number of hospital days per patient. Hospitalization data were collected from statewide or VA databases at 30 days postenrollment in Trial 1, twelve months postenrollment in Trial 2, and nine months postenrollment in Trial 3.
PRINCIPAL FINDINGS


Over 9398 observed patient months, the total number of hospital days per patient in the intervention group was 66 percent of the total in the control group (849 days for 674 intervention patients vs 1258 days for 660 control patients, incidence rate ratio (IRR) 0.66, P < .0001). This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03). The intervention also decreased rates of hospitalization outside patients' primary health system (18.8 percent vs 34.8 percent, P = .0023).
CONCLUSIONS


Data from three randomized clinical trials across multiple settings show that a standardized CHW intervention reduced total hospital days and hospitalizations outside the primary health system. This is the largest analysis of randomized trials to demonstrate reductions in hospitalization with a health system-based social intervention.",2020,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","['Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured', 'outpatients at two academic primary care clinics', 'hospitalized general medical patients', 'outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices', 'Pooled data from three randomized clinical trials (n\xa0', 'disadvantaged patients with multiple chronic conditions', '1340) conducted between 2011 and 2016']","['standardized community health worker intervention', 'standardized CHW intervention', 'usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation', 'standardized community health worker (CHW) intervention']","['incidence rate ratio', 'total hospital days and hospitalizations', ""rates of hospitalization outside patients' primary health system"", 'total number of hospital days per patient', 'shorter mean length of stay', 'cause hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.281442,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Vasan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Morgan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mitra', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Kangovi', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Health services research,['10.1111/1475-6773.13321']
2314,32643211,Randomised clinical trial of a motivational interviewing intervention to improve oral health education amongst older adults in Philadelphia: 12-month evaluation of non-clinical outcomes.,"OBJECTIVES


We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
BACKGROUND


There is lack of information on how different types of oral health educational interventions affect older adults on non-clinical outcomes including changes in oral health-related quality of life (OHRQoL), oral health self-efficacy (SE) and oral health knowledge (OHK).
MATERIALS AND METHODS


One hundred and eighty patients were randomly allocated to TOHE, MI and SC groups. Treatment fidelity was measured in 16 non-study patients. The MI intervention was administered by a public health dental hygienist (PHDH). All interviews were audio-recorded and coded by an expert using the Motivational Interviewing Treatment Integrity (MITI) Code. Multivariable longitudinal regression analyses accounting for baseline demographics and correlated errors due to repeated measures via generalised estimating equation were conducted following an intention to treat approach.
RESULTS


Over the 1-year follow-up, SE and OHRQoL scores significantly improved amongst the MI group whereas both outcomes worsened amongst the SC group. During the same period, SE and OHRQoL did not change in the TOHE group.
CONCLUSION


Findings from the study support the fidelity of this intervention and the improvement of all non-clinical outcomes after 12 months amongst the MI group.",2020,"We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
","['One hundred and eighty patients', 'older adults in Philadelphia', '16 non-study patients']","['motivational interviewing intervention', 'individual-based oral health education intervention utilising motivational interviewing (MI) techniques', 'traditional oral health education intervention (TOHE) and a standard of care group (SC', 'MI intervention', 'oral health educational interventions']","['Treatment fidelity', 'oral health-related quality of life (OHRQoL), oral health self-efficacy (SE) and oral health knowledge (OHK', 'SE and OHRQoL', 'oral health education']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}]",180.0,0.0383083,"We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
","[{'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Tellez', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Shanon', 'Initials': 'S', 'LastName': 'Myers Virtue', 'Affiliation': 'Helen F. Graham Cancer Center & Research Institute Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Neckritz', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sungwoo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Bhoopathi', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Colgate Palmolive Company, Toronto, ON, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Shearer', 'Affiliation': 'Colgate Palmolive Company, New York, New York, USA.'}, {'ForeName': 'Amid', 'Initials': 'A', 'LastName': 'Ismail', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}]",Gerodontology,['10.1111/ger.12488']
2315,32643265,Multifocal electroretinogram response following subthreshold nanosecond laser intervention in age-related macular degeneration.,"IMPORTANCE


The effect of subthreshold nanosecond laser (SNL) treatment on retinal function remains unknown.
BACKGROUND


SNL treatment has been studied as a potential intervention in intermediate age-related macular degeneration AMD (iAMD). This study investigated the longitudinal effect of SNL treatment on retinal function. Design This was a sub-study of the LEAD trial; a 36-month, multicenter, randomized, sham-controlled trial.
PARTICIPANTS


Subjects with iAMD.
METHODS


Eligible participants were assigned randomly to receive SNL or sham treatment to the study eye at 6-monthly visits. Multifocal electroretinography (mfERG) was performed at each study visit from a study site. The mfERG responses were grouped into three regions (central, middle and outer rings) and compared between the SNL and sham group.
MAIN OUTCOME MEASURES


mfERG P1 response amplitude and implicit time.
RESULTS


Data were collected from 50 subjects (26 in the SNL group, 24 in the sham group). At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings. In the sham group, the P1 amplitude gradually decreased over time (P<0.05). In the SNL group, there was an improvement in P1 amplitude which became statistically significant at the 36-month visit, detected in both the treated and fellow eyes at the central (P=0.005) and middle ring (P=0.007) but not at the outer ring (P=0.070). No difference in P1 implicit time detected between the groups (P>0.05).
CONCLUSIONS AND RELEVANCE


SNL treatment improved electrophysiological function. mfERG could be useful for monitoring AMD progression and evaluating the efficacy of SNL treatment.",2020,"At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings.","['age-related macular degeneration', 'Eligible participants', 'Subjects with iAMD', '50 subjects (26 in the SNL group, 24 in the sham group']","['subthreshold nanosecond laser intervention', 'SNL', 'subthreshold nanosecond laser (SNL', 'Multifocal electroretinography (mfERG']","['P1 implicit time', 'mfERG P1 response amplitude and implicit time', 'P1 amplitudes', 'Multifocal electroretinogram response', 'P1 amplitude', 'retinal function', 'electrophysiological function']","[{'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0456358', 'cui_str': 'ERG response'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",50.0,0.0750606,"At baseline, the P1 amplitudes of both the study eyes and the fellow eyes were similar between the groups at all rings.","[{'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Makeyeva', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caruso', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Baglin', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Pyrawy', 'Initials': 'P', 'LastName': 'Sivarajah', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13823']
2316,32643311,A network physiology approach to oxygen saturation variability during normobaric hypoxia.,"NEW FINDINGS


What is the central question of this study? What is the physiological interpretation of SpO 2  fluctuations observed during normobaric hypoxia in healthy individuals? What is the main finding and its importance? There is a significant flow of information between SpO 2  and other cardio-respiratory time-series during graded hypoxia. Analysis of the pattern of SpO 2  variations has potential for non-invasive assessment of the engagement of respiratory control system in health and disease.
ABSTRACT


Background peripheral capillary oxygen saturation (SpO 2  ) exhibits a complex pattern of fluctuations during hypoxia. The physiological interpretation of SpO 2  variability is not well understood. In this study, we tested the hypothesis that SpO 2  fluctuation carries information about integrated cardio-respiratory control in healthy individuals using a network physiology approach. Method we explored the use of transfer entropy in order to compute the flow of information between cardio-respiratory signals during hypoxia. Twelve healthy males (age [SD] 22 [4] years) were exposed to four simulated environments (fraction of inspired oxygen [F I  O 2  ]: 0.12, 0.145, 0.17, and 0.2093) for 45 minutes, in a single blind randomised controlled design. The flow of information between different physiological parameters (SpO 2  , respiratory frequency, tidal volume, minute ventilation, heart rate, end-tidal pressure of O 2  and CO 2  ) were analysed using transfer entropy. Results normobaric hypoxia was associated with a significant increase in entropy of the SpO 2  time-series. The transfer entropy analysis showed that, particularly at F I  O 2  : 0.145 and 0.12, the flow of information between SpO 2  and other physiological variables exhibits a bidirectional relationship. While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia, SpO 2  remained the main hub of this network. Conclusion SpO 2  fluctuations during graded hypoxia exposure carry information about cardio-respiratory control. Therefore, SpO 2  entropy analysis has the potential for non-invasive assessment of the functional connectivity of respiratory control system in various healthcare settings. This article is protected by copyright. All rights reserved.",2020,"While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia, SpO 2  remained the main hub of this network.","['Twelve healthy males (age [SD] 22 [4] years', 'healthy individuals']",[],"['flow of information between different physiological parameters (SpO 2  , respiratory frequency, tidal volume, minute ventilation, heart rate, end-tidal pressure of O 2  and CO 2  ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",12.0,0.0544062,"While reciprocal interactions were observed between different cardio-respiratory parameters during hypoxia, SpO 2  remained the main hub of this network.","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Williams', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Nawamin', 'Initials': 'N', 'LastName': 'Panyapiean', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Bhogal', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Tipton', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Corbett', 'Affiliation': 'Extreme Environments Laboratory, School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Mani', 'Affiliation': 'Network Physiology Laboratory, UCL Division of Medicine, University College London, London, United Kingdom.'}]",Experimental physiology,['10.1113/EP088755']
2317,32638095,Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.,"PURPOSE


To identify predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.
METHODS


This was a planned secondary analysis of data from a published randomized controlled trial comparing expectant management with vaginal single dose of 800 µg misoprostol treatment of women with embryonic or anembryonic miscarriage. Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin, parity, previous vaginal deliveries, gestational age, clinical symptoms (bleeding and pain), mean diameter and shape of the gestational sac, crown-rump-length, type of miscarriage, and presence of blood flow in the intervillous space-were tested as predictors of treatment success (no gestational sac in the uterine cavity and maximum anterior-posterior intracavitary diameter was ≤ 15 mm as measured with transvaginal ultrasound on a sagittal view) in univariable and multivariable logistic regression.
RESULTS


Variables from 174 women (83 expectant management versus 91 misoprostol) were analyzed for prediction of complete miscarriage at ≤ 17 days. In patients managed expectantly, the rate of complete miscarriage was 62.7% (32/51) in embryonic miscarriages versus 37.5% (12/32) in anembryonic miscarriages (P = 0.02). In multivariable logistic regression, the likelihood of success increased with increasing gestational age, increasing crown-rump-length and decreasing gestational sac diameter. Misoprostol treatment was successful in 80.0% (73/91). No variable predicted success of misoprostol treatment.
CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage. Gestational age, crown-rump-length, and gestational sac diameter are independent predictors of success of expectant management. Predictors of treatment success may help counselling women with early miscarriage.",2020,"CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage.","['women with vaginal bleeding', '174 women (83 expectant management versus 91', 'women with embryonic or anembryonic miscarriage', 'counselling women with early miscarriage']","['expectant management with vaginal single dose of 800\xa0µg misoprostol', 'Misoprostol', 'misoprostol']","['Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin, parity, previous vaginal deliveries, gestational age, clinical symptoms (bleeding and pain), mean diameter and shape of the gestational sac, crown-rump-length, type of miscarriage, and presence of blood flow', 'rate of complete miscarriage', 'embryonic miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C2825540', 'cui_str': 'Crown rump length'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1306041', 'cui_str': 'Complete miscarriage'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",,0.09524,"CONCLUSIONS


Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fernlund', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden. anna.fernlund@skane.se.'}, {'ForeName': 'Ligita', 'Initials': 'L', 'LastName': 'Jokubkiene', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}, {'ForeName': 'Povilas', 'Initials': 'P', 'LastName': 'Sladkevicius', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}, {'ForeName': 'Lil', 'Initials': 'L', 'LastName': 'Valentin', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Jan Waldenströms gata 47, 20502, Malmö, SE, Sweden.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05672-6']
2318,32638144,Impacts of a Home Visiting Program Enhanced with Content on Healthy Birth Spacing.,"OBJECTIVES


This study sought to determine the impact of Healthy Families Healthy Futures (HFHF) enhanced with Steps to Success (STS). HFHF is a structured home visiting program for teen parents in Houston that focuses on improving parenting skills and preventing child abuse. HFHF enhanced with STS includes content and activities aimed to reduce repeat pregnancies within 24 months after the first child's birth.
METHODS


The study team recruited 248 young mothers for the study, primarily through local health clinics and schools, and then randomly assigned them to either a treatment group that was eligible to participate in HFHF enhanced with STS or to a control group. The control group was not offered any other program through the study. Outcomes were measured by a survey administered 12 months after program intake, in five domains aligned with the program's logic model: (1) exposure to information related to program content, (2) contraception knowledge, (3) contraception use, (4) enhanced family functioning, and (5) child health and development. To estimate program impacts, we used ordinary least squares regression, controlling for demographics and baseline measures of the outcome variables, if available. We use both frequentist approaches (calculations of statistical significance) and Bayesian posterior probabilities to interpret the findings.
RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively. Using Bayesian posterior probabilities, there is an 85% chance that the program had a favorable effect on these outcomes. We also calculate a probability of 77% that the program had a favorable impact on long-acting reversible contraceptive (LARC) use, but a probability of 89% that the program reduced knowledge of birth control pills; these two results were not statistically significant (p = .17 and .10, respectively).
CONCLUSIONS FOR PRACTICE


These findings are primarily favorable and consistent with the program content and goals. Smaller than anticipated sample sizes due to recruitment challenges increased the chances for random error to affect the ability to detect statistically significant differences on many of our other outcomes; Bayesian posterior probabilities can therefore aid in interpreting the impact estimates. More research of this promising model is warranted.",2020,"RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively.","['248 young mothers for the study, primarily through local health clinics and schools', 'Healthy Families Healthy Futures (HFHF) enhanced with Steps to Success (STS']","['Home Visiting Program', 'HFHF', 'HFHF enhanced with STS or to a control group']","['parenting skills', 'knowledge of birth control pills', 'program content, (2) contraception knowledge, (3) contraception use, (4) enhanced family functioning, and (5) child health and development', 'Healthy Birth Spacing', 'long-acting reversible contraceptive (LARC']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",248.0,0.0298537,"RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zief', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA. szief@mathematica-mpr.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Deke', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burkander', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Langan', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Subuhi', 'Initials': 'S', 'LastName': 'Asheer', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02968-6']
2319,32638172,Intravenous Migraine Treatment in Children and Adolescents.,"PURPOSE OF REVIEW


Pediatric migraine is a common, chronic, and disabling neurological disorder in children and adolescents. Outpatient management is not always effective, and intravenous migraine management may be necessary for headache treatment in the pediatric emergency department. Most current treatment is based on retrospective evidence and there is a lack of well-designed randomized double-blinded controlled pediatric studies. Intravenous drug treatment agents including intravenous fluids, prochlorperazine, diphenhydramine, metoclopramide, dexamethasone, magnesium, valproate and propofol, and dihydroergotamine are reviewed in this paper.
RECENT FINDINGS


Nineteen studies were reviewed including one prospective randomized double-blind; one single-blinded randomized; one prospective; and one open-label, randomized clinical trial. Most studies were retrospective and the quality of the studies was limited. No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.",2020,"No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.","['Children and Adolescents', 'children and adolescents', 'Nineteen studies']","['Intravenous Migraine', 'prochlorperazine, diphenhydramine, metoclopramide, dexamethasone, magnesium, valproate and propofol, and dihydroergotamine']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0012291', 'cui_str': 'Dihydroergotamine'}]",[],19.0,0.131823,"No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.","[{'ForeName': 'Klaus G', 'Initials': 'KG', 'LastName': 'Werner', 'Affiliation': 'Division of Pediatric Neurology, Duke University Medical Center, Durham, NC, 27710, USA. klaus.werner@duke.edu.'}, {'ForeName': 'Sharoon', 'Initials': 'S', 'LastName': 'Qaiser', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Marielle A', 'Initials': 'MA', 'LastName': 'Kabbouche', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center/University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Medical Center Library & Archives, Duke University Medical Center, Durham, NC, 27710, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Maconochie', 'Affiliation': 'Department of Pediatric Emergency Medicine Division of Medicine, Imperial College NHS Healthcare Trust, Praed Street, London, W2 1NY, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Hershey', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center/University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}]",Current pain and headache reports,['10.1007/s11916-020-00867-7']
2320,32638173,The effects of systemic proteolytic enzyme therapy on pain and swelling in third molar surgery equal to diclofenac therapy: a prospective randomized double blinded clinical trial.,"OBJECTIVE


The aim of this study was to determine if the timing of administration of systemic enzyme therapy [SET] has any effect on its efficacy in controlling postoperative sequelae of third molar surgery.
STUDY DESIGN


A double blinded prospective randomized control trial was planned. The sample included patients requiring impacted mandibular third molar surgical extraction. Patients were randomly allocated to four groups (50 patients per group). Group A included administration of SET 48 h prior to surgery; Group B, started on the day of surgery; Group C started immediately after surgery and control group D included NSAIDS started 3 h after surgery. The predictor variable was timing of administration of SET. The primary outcome variables were pain and swelling measured on 1st day, 5th day, and 7th day after surgery.
FINDINGS


Groups A and D reported lower mean and median VAS scores and lesser swelling than groups C and D on postop day 1. On days 5 and 7, all four groups were comparable. On overall analysis, no statistically significant difference (p > 0.05) was evident.
INTERPRETATION


The results of the study showed that the differences in swelling and pain with starting the SET 2 days before, on the day of surgery, or immediately after when compared with diclofenac was not statistically significant.
TRIAL REGISTRATION


CTRI Registration Number CTRI/2018/03/012502.",2020,"FINDINGS


Groups A and D reported lower mean and median VAS scores and lesser swelling than groups C and D on postop day 1.","['patients requiring impacted mandibular third molar surgical extraction', 'pain and swelling in third molar surgery equal to diclofenac therapy']","['systemic proteolytic enzyme therapy', 'systemic enzyme therapy [SET', 'diclofenac']","['swelling and pain', 'pain and swelling', 'median VAS scores and lesser swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936197', 'cui_str': 'Enzymotherapy'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439092', 'cui_str': '<'}]",,0.528652,"FINDINGS


Groups A and D reported lower mean and median VAS scores and lesser swelling than groups C and D on postop day 1.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gandhewar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Andrade', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India. agg.neha61@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Choradia', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Mathai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nerurkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Dr. A.L.Nair Road, Opp. Maratha Mandir, Mumbai, 400008, India.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00854-7']
2321,32638239,"Comparison of low-level laser treatment and extracorporeal shock wave therapy in subacromial impingement syndrome: a randomized, prospective clinical study.","The aim of this study was to compare the efficacy of low-level laser treatment (LLLT) and extracorporeal shock wave therapy (ESWT) in the treatment of subacromial impingement syndrome (SIS). Seventy-one patients with subacromial impingement were randomly assigned to LLLT (n = 37) and ESWT (n = 34) groups. The patients received a total of 15 sessions of LLLT or once a week for 3 sessions of ESWT. All patients, before treatment, at the end of treatment, and 3 months after treatment, were evaluated with range of motion (ROM), visual analogue pain scale (VAS pain), Shoulder Pain and Disability Index (SPADI), Beck Depression and Anxiety Inventories, the Short Form Health Survey (SF-36), and Pittsburgh Sleep Quality Index (PSQI). In both groups, there was a significant improvement in all outcome measures (p < 0.05) except the mental health score in the LLLT group. ESWT group showed more improvements in terms of SPADI disability and total scores, PSQI, and physical-mental health scores at the end of treatment (p < 0.05). The improvement in VAS pain day and SPADI scores at the third month was significantly more evident in the ESWT group (p < 0.05). Both LLLT and ESWT treatments are effective in the treatment of SIS in the short-medium term and can be used in clinical practice. Future larger prospective clinical trials are needed to investigate the long-term efficacy and optimal treatment protocol of LLLT and ESWT in SIS.",2020,The improvement in VAS pain day and SPADI scores at the third month was significantly more evident in the ESWT group (p < 0.05).,"['Seventy-one patients with subacromial impingement', 'subacromial impingement syndrome', 'subacromial impingement syndrome (SIS']","['LLLT', 'low-level laser treatment (LLLT) and extracorporeal shock wave therapy (ESWT', 'low-level laser treatment and extracorporeal shock wave therapy', 'LLLT and ESWT', 'ESWT']","['SPADI disability and total scores, PSQI, and physical-mental health scores', 'VAS pain day and SPADI scores', 'mental health score', 'range of motion (ROM), visual analogue pain scale (VAS pain), Shoulder Pain and Disability Index (SPADI), Beck Depression and Anxiety Inventories, the Short Form Health Survey (SF-36), and Pittsburgh Sleep Quality Index (PSQI']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",71.0,0.0361057,The improvement in VAS pain day and SPADI scores at the third month was significantly more evident in the ESWT group (p < 0.05).,"[{'ForeName': 'Sevtap', 'Initials': 'S', 'LastName': 'Badıl Güloğlu', 'Affiliation': 'Faculty of Medicine, Physical Medicine and Rehabilitation, Kafkas University, Kars Merkez, Kars, Turkey. drsevtapbadil@hotmail.com.'}]",Lasers in medical science,['10.1007/s10103-020-03093-0']
2322,32638266,"Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry.","INTRODUCTION


Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany.
METHODS AND RESULTS


The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
CONCLUSIONS


In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.",2020,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","['5015 patients with non-valvular atrial fibrillation', 'patients with non-valvular atrial fibrillation', 'Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany', 'unselected patients with atrial fibrillation', 'unselected patients in Germany']","['Apixaban', 'warfarin', 'apixaban']","['NOACs or VKAs', 'non-fatal stroke', 'Inappropriate underdosing of apixaban', 'ISTH major bleeding', 'cause mortality', 'non-fatal myocardial infarction', 'moderate or minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0642228', 'cui_str': 'N(4)-oleylcytosine arabinoside'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",5015.0,0.0273181,"After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively.
","[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany. uwe.zeymer@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lober', 'Affiliation': 'Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Kardiologische Praxis, Stahnsdorf, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Praxis Dr. Richard, Erfurt, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Praxis Dr. Schäfer, Herfurth, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Taggeselle', 'Affiliation': 'Praxis Markkleeberg, Markkleeberg, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Kabitz', 'Affiliation': 'Klinikum Konstanz, Konstanz, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Prondzinsky', 'Affiliation': 'Carl-Von-Basedow-Klinikum Merseburg, Merseburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Süselbeck', 'Affiliation': 'Kardiologische Praxisklinik Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology and therapy,['10.1007/s40119-020-00188-1']
2323,32638392,The impact of different hair-removal behaviours on the biophysical and biochemical characteristics of female axillary skin.,"OBJECTIVE


The impact of hair removal on the biophysical and biochemical characteristics of human axillary skin is not fully understood. This study investigated the effect of different hair-removal techniques on biophysical parameters and the concentrations of key inflammatory biomarkers in the axillae of female Thai subjects. Axillary hair was removed by shaving, plucking or waxing.
METHODS


Following a 2-week washout phase without hair removal, subjects underwent visual assessment for erythema and skin dryness in one (randomised) axilla, then hair was removed from the axilla by shaving, plucking or waxing according to each subject's established habit. Erythema and dryness were assessed again 30 min after hair removal, and buffer scrubs collected from depilated and non-depilated axillae and analysed for inflammatory cytokines; after a further 48 h, erythema, dryness and post-inflammatory hyperpigmentation (PIHP) were assessed in the depilated axilla. Biophysical assessments (skin hydration, barrier integrity, elasticity and roughness) were made in depilated and non-depilated axillae.
RESULTS


All three hair-removal techniques induced an increase in axillary erythema and skin dryness. Shaving was associated with significantly less erythema (P < 0.01), but significantly greater skin dryness (P < 0.05) versus the other techniques 30 min after hair removal. There were no between-technique differences in PIHP or biophysical parameters. Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
CONCLUSION


This is the first study to identify the principal cytokines associated with the inflammatory process triggered by axillary hair removal. A single hair-removal treatment did not appear to induce PIHP or further biophysical changes to the skin.",2020,"Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
","['female axillary skin', 'female Thai subjects']",['hair-removal techniques'],"['IL-8 concentration', 'Interleukins IL-1α and IL-1RA concentrations', 'axillary erythema and skin dryness', 'Biophysical assessments (skin hydration, barrier integrity, elasticity and roughness', 'Erythema and dryness', 'PIHP or biophysical parameters', 'erythema, dryness and post-inflammatory hyperpigmentation (PIHP', 'skin dryness', 'erythema']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0222146', 'cui_str': 'Skin structure of axilla'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0592639,"Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Evans', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Marriott', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Arnold', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}]",International journal of cosmetic science,['10.1111/ics.12648']
2324,32638409,Dietary macronutrient regulation of acyl and desacyl ghrelin concentrations in children with Prader-Willi syndrome (PWS).,"BACKGROUND


The effects of dietary macronutrients on orexigenic and anorexigenic hormones in children are poorly understood.
OBJECTIVE


To explore effects of varying dietary macronutrients on appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide 1 (GLP-1), peptide tyrosine tyrosine (PYY), and insulin) in children with PWS and healthy children (HC).
DESIGN


Randomized, cross-over experiments compared two test diets [High Protein-Low Carbohydrate (HP-LC) and High Protein-Low Fat (HP-LF)] to a STANDARD meal (55% carbohydrate, 30% fat, 15% protein). Experiment 1 included ten children with PWS (median age 6.63y; BMI z 1.05); experiment 2 had seven HC (median age 12.54y; BMI z 0.95). Blood samples were collected at baseline and at 60-minute intervals for 4 hours. Independent linear mixed models were adjusted for age, sex, and BMI z-score.
RESULTS


Fasting and post-prandial AG and DAG concentrations are elevated in PWS children; the ratio of AG/DAG is normal. Food consumption reduced AG and DAG concentrations in both PWS and HC. GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04). The fasting proinsulin to insulin ratio (0.08 vs. 0.05) was higher in children with PWS (p=0.05) than in HC. Average appetite scores in HC declined after all three meals (p = 0.02) but were lower after the HP-LC and HP-LF meals than the STANDARD meal.
CONCLUSION


Altered processing of proinsulin and increased GLP-1 secretion in children with PWS after a high protein meal intake might enhance satiety and reduce energy intake.",2020,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"['children with PWS', 'children with Prader-Willi syndrome (PWS', 'children with PWS and healthy children (HC', 'Experiment 1 included ten children with PWS (median age 6.63y; BMI z 1.05); experiment 2 had seven HC (median age 12.54y; BMI z 0.95']","['varying dietary macronutrients', 'diets [High Protein-Low Carbohydrate (HP-LC) and High Protein-Low Fat (HP-LF', 'dietary macronutrients']","['Fasting and post-prandial AG and DAG concentrations', 'Blood samples', 'GLP-1 levels', 'GLP-1 secretion', 'fasting proinsulin to insulin ratio', 'Average appetite scores in HC', 'AG and DAG concentrations', 'satiety and reduce energy intake', 'appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide\xa01 (GLP-1), peptide tyrosine tyrosine (PYY), and insulin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0011967', 'cui_str': '1,2,5,6-Dianhydrogalactitol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0965048', 'cui_str': 'ghrelin, des-n-octanoyl'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}]",10.0,0.035134,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alsaif', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Pakseresht', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Gaylinn', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Thorner', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Field', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}]",Clinical endocrinology,['10.1111/cen.14279']
2325,32638427,Biochemical and Pain Comparisons Between the Laser Lancing Device and Needle Lancets for Capillary Blood Sampling: A Randomized Control Trial.,"BACKGROUND AND OBJECTIVES


Patients around the world use a lancing device to perform self-monitoring of blood sugar (SMBG). However, there are always fears of needles and pain. Therefore, less painful devices are being developed. The purpose of this study was to compare the usefulness and safety of a laser lancing device (without a needle) to a conventional needle lancet (with a needle) for capillary blood sampling.
STUDY DESIGN/MATERIALS AND METHODS


A total of 40 healthy subjects were enrolled in the study. Capillary blood was collected from a laser lancing device (without a needle) and a conventional needle lancet (with a needle) on opposite fingers, the choice of which was randomly selected. The laser lancing device (LMT-3000) uses a 2940 nm mono-pulse laser, a radiation field of 350 μm, laser energy of 210 mJ, and a 3.7 V battery. One week later, capillary blood was obtained by switching the devices and fingers. The biochemical measurements and pain were compared between the two groups. Puncture pain was measured on a pain scale from 0 to 10.
RESULT


All patients were tested with both a laser lancing device and a conventional needle lancet. In the biochemical analysis, the blood glucose level was 103.21 ± 17.20 mg/dl in laser lancing device group and 102.25 ± 22.44 mg/dl in the conventional needle lancet group, and there were no significant differences between the two groups (P = 0.940). The pH, CO 2  , O 2  , lactate and hematocrit levels of the blood were no significant differences between the two groups. In the first trial, the median pain score (interquartile range) of patients using laser lancing device was 2.0 (1.0-3.0), whereas it was 2.5 (2.0-4.0) in patients using a conventional needle lancet (P = 0.029). In the second trial, one week later, the median pain score in the laser lancing device group was 2.5 (1.0-4.0), whereas it was 3.5 (2.25-5.0) in the conventional needle lancet group (P = 0.001). The difference in pain scores between the first and second trials was significant in the conventional needle lancet group (P = 0.007), but not in the laser lancing device group (P = 0.150).
CONCLUSION


There was no difference in biochemical results between the laser lancing device group and the conventional needle lancet group. The laser lancing device demonstrated comparatively lower pain than the conventional needle lancet. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"The pH, CO 2  , O 2  , lactate and hematocrit levels of the blood were no significant differences between the two groups.",['40 healthy subjects were enrolled in the study'],"['conventional needle lancet', 'laser lancing device and a conventional needle lancet', 'laser lancing device (LMT-3000', 'laser lancing device', 'Laser Lancing Device and Needle Lancets', 'conventional needle lancet (with a needle']","['pain scores', 'median pain score', 'biochemical results', 'Biochemical and Pain Comparisons', 'blood glucose level', 'pH, CO 2  , O 2  , lactate and hematocrit levels of the blood', 'Puncture pain', 'Capillary blood', 'pain', 'pain scale', 'biochemical measurements and pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0777169', 'cui_str': 'Lancet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0522666', 'cui_str': 'Lance'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0470279', 'cui_str': '3000'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",40.0,0.038572,"The pH, CO 2  , O 2  , lactate and hematocrit levels of the blood were no significant differences between the two groups.","[{'ForeName': 'Won Sang', 'Initials': 'WS', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, 201 Manghyang-ro, Dongnam-gu, Cheonan, 31116, Korea.'}, {'ForeName': 'Junwon', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Surgery, Dankook University College of Medicine, 201 Manghyang-ro, Dongnam-gu, Cheonan, 31116, Korea.'}, {'ForeName': 'Phil-Sang', 'Initials': 'PS', 'LastName': 'Chung', 'Affiliation': 'Department of Otolaryngology-Head and Neck surgery, Dankook University College of Medicine, 201 Manghyang-ro, Dongnam-gu, Cheonan, 31116, Korea.'}, {'ForeName': 'Seung Hoon', 'Initials': 'SH', 'LastName': 'Woo', 'Affiliation': 'Department of Otolaryngology-Head and Neck surgery, Dankook University College of Medicine, 201 Manghyang-ro, Dongnam-gu, Cheonan, 31116, Korea.'}]",Lasers in surgery and medicine,['10.1002/lsm.23298']
2326,32638445,Effect of cinnamon on migraine attacks and inflammatory markers: A randomized double-blind placebo-controlled trial.,"Migraine is the most common type of primary headaches. Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain. Cinnamon has anti-inflammatory and neuroprotective properties. Thus, the aim of this study was to assess the effect of cinnamon on migraine attacks and inflammatory status. Fifty patients with migraine were randomized to receive either cinnamon powder (three capsules/day each containing 600 mg of cinnamon) or three placebo capsules/day each containing 100 mg of corn starch (control group) for 2 months. Serum levels of IL-6, CGRP and NO were measured at baseline and at the end of the study. The frequency, severity and duration of pain attacks were also recorded using questionnaire. Serum concentrations of IL-6 and NO were significantly reduced in the cinnamon group compared with the control group (p < .05). However, serum levels of CGRP remained unchanged in both groups. The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group. Cinnamon supplementation reduced inflammation as well as frequency, severity and duration of headache in patients with migraine. Cinnamon could be regarded as a safe supplement to relieve pain and other complications of migraine.",2020,"The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group.","['Fifty patients with migraine', 'patients with migraine']","['Cinnamon supplementation', 'cinnamon', 'cinnamon powder (three capsules/day each containing 600\u2009mg of cinnamon) or three placebo capsules/day each containing 100\u2009mg of corn starch', 'placebo']","['migraine attacks and inflammatory markers', 'serum levels of CGRP', 'frequency, severity and duration of migraine attacks', 'frequency, severity and duration of headache', 'Serum levels of IL-6, CGRP', 'Serum concentrations of IL-6', 'migraine attacks and inflammatory status', 'frequency, severity and duration of pain attacks', 'Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0423717', 'cui_str': 'Neurogenic pain'}]",50.0,0.147185,"The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group.","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Zareie', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Neurology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hasanzadeh', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6721']
2327,32638504,"Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Randomized, Double-blind, Active-comparator, Multi-center, Multi-country Trial.","OBJECTIVE


The SELECT-EARLY trial studied the effect of upadacitinib, an oral, reversible, JAK inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to methotrexate.
METHODS


Patients were randomized (n=947, 1:1:1) to once-daily upadacitinib (15mg or 30mg) or weekly methotrexate (7.5-20mg/week) for 24 weeks. The primary endpoints were: proportions of patients achieving ≥50% response in the American College of Rheumatology (ACR) criteria at Week 12, and proportions achieving a 28-joint Disease Activity Score including C-reactive protein (DAS28[CRP]) of <2.6 at Week 24. Data are presented through Week 24.
RESULTS


At baseline, median disease duration was 0.5 years (range 0-44 years). 840 (89%) patients completed 24 weeks of treatment. The study met both primary endpoints for upadacitinib 15mg and 30mg versus methotrexate (ACR50 at Week 12: 52% and 56% versus 28%, P<0.001; DAS28(CRP) <2.6 at Week 24: 48% and 50% versus 19%, P<0.001). Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate. Overall, 88% and 89% of upadacitinib 15mg and 30mg patients had no radiographic progression (mTSS ≤0; methotrexate: 78%; at least P<0.01). Through Week 24, the frequency of treatment-emergent adverse events was similar between the methotrexate (65%) and upadacitinib 15mg arms (64%), but slightly higher in the upadacitinib 30mg arm (71%). Six deaths were reported (upadacitinib 15mg: 2, upadacitinib 30mg: 3, methotrexate: 1).
CONCLUSION


Both doses of upadacitinib monotherapy demonstrated significant improvements in clinical, radiographic, and patient-reported outcomes versus methotrexate.",2020,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"['Patients were randomized (n=947, 1:1:1) to', 'naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY', 'patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to methotrexate']","['upadacitinib 15mg and 30mg versus methotrexate ', 'Methotrexate', 'upadacitinib monotherapy', 'Upadacitinib Monotherapy', 'methotrexate', 'once-daily upadacitinib', 'upadacitinib, an oral, reversible, JAK inhibitor']","['Efficacy and Safety', 'median disease duration', 'frequency of treatment-emergent adverse events', 'proportions of patients achieving ≥50% response in the American College of Rheumatology (ACR) criteria at Week 12, and proportions achieving a 28-joint Disease Activity Score including C-reactive protein (DAS28[CRP', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.286938,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'AbbVie Inc. North Chicago, North Chicago, IL, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': 'The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital Universitario Marques de Valdecilla, Santander, IDIVAL, Cantabria, Spain.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41384']
2328,32638545,Percutaneous Vertebroplasty with Side-Opening Cannula or Front-Opening Cannula in the Treatment of Kummell Disease?,"OBJECTIVE


To explore the effect of bone cement distribution, cement leakage, and clinical outcomes with side-opening cannula for bone cement injection in percutaneous vertebroplasty (PVP) in treatment of Kummell disease.
METHODS


A prospective study of patients with Kummell disease undergoing PVP was conducted from April 2012 to September 2017. In total, 43 patients (11 males, 32 females) with Kummell disease who received bilateral PVP were included in the study. The patients were divided into front-opening cannulas (FOC) group with front-opening cannulas and side-opening cannulas (SOC) group with side-opening cannulas. All patients were followed up for 6 months. The patient general information such as gender, age, bone density, compression ratio, operative time, and location of fracture vertebrae were recorded. Visual analogue scale (VAS), Oswestry Disability Index (ODI), bone cement distribution, radiation exposure time, bone cement leakage rate and vertebral height, and kyphosis angle were measured and compared for two groups before surgery, 1 day and 6 months after surgery.
RESULTS


A total of 43 patients were enrolled, including 11 males and 32 females, aged 61-84 years. The bone density (T value) was 2.5 ± 0.6 in FOC group and 2.4 ± 0.6 in SOC group (P > 0.05). The compression ratio and operative time were 36.1% ± 13.0%, 39.3 ± 7.9 min in FOC group and 35.2% ± 13.7%, 40.0 ± 10.7 min in SOC group (P > 0.05). There was no significance between FOC and SOC groups in the location of fracture vertebrae. All patients underwent at least 6 months of follow-up. At 6 months postoperatively, the VAS and ODI were significantly higher in the FOC group (3.0 ± 0.8, 35.7% ± 2.1%) than in the SOC group (1.3 ± 0.4, 18.6% ± 2.4%) (P < 0.05). The cement leakage rate of the SOC group was 4.8%, which was lower than that of the FOC group (31.8%, P < 0.05), and the bone cement distribution ratio was higher than that of the FOC group (63.1% ± 7.9% vs 40.5% ± 8.6%, P < 0.05). At 6 months after operation, the height of the anterior and posterior vertebral bodies of the patients in the SOC group restored better than the FOC group (anterior SOC: FOC 5.1 ± 0.5 mm vs 4.5 ± 0.5 mm; posterior SOC: FOC 0.6 ± 0.1 mm vs 0.3 ± 0.1 mm, P < 0.05), and the kyphosis correction was more obvious than patients in FOC group (SOC: FOC 8.5° ± 1.4° vs 4.6° ± 0.8°, P < 0.05).
CONCLUSION


Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.",2020,"Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.","['43 patients (11 males, 32 females) with Kummell disease who received bilateral PVP were included in the study', '43 patients were enrolled, including 11 males and 32 females, aged 61-84\u2009years', 'patients with Kummell disease undergoing PVP was conducted from April 2012 to September 2017']","['FOC', 'front-opening cannulas (FOC) group with front-opening cannulas and side-opening cannulas (SOC) group with side-opening cannulas', 'percutaneous vertebroplasty (PVP', 'Percutaneous vertebroplasty with side-opening cannula', 'side-opening cannula', 'Percutaneous Vertebroplasty with Side-Opening Cannula or Front-Opening Cannula']","['compression ratio and operative time', 'VAS and ODI', 'Visual analogue scale (VAS), Oswestry Disability Index (ODI), bone cement distribution, radiation exposure time, bone cement leakage rate and vertebral height, and kyphosis angle', 'height of the anterior and posterior vertebral bodies', 'bone cement distribution ratio', 'bone density (T value', 'bone density, compression ratio, operative time, and location of fracture vertebrae', 'kyphosis correction', 'cement leakage rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152088', 'cui_str': 'Traumatic spondylopathy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]",43.0,0.0197373,"Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.","[{'ForeName': 'Xi-Fa', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ping', 'Affiliation': 'Department of Orthopaedics, Rizhao Central Hospital, Rizhao, China.'}, {'ForeName': 'Xiang-Qin', 'Initials': 'XQ', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopaedics, Chongqing University Central Hospital, Chongqing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Spinal Surgery, Zibo Central Hospital, ZiBo, China.'}, {'ForeName': 'Dong-Jin', 'Initials': 'DJ', 'LastName': 'Wu', 'Affiliation': 'Department of Spinal Surgery, The Second Hospital of Shandong University, Jinan, China.'}]",Orthopaedic surgery,['10.1111/os.12730']
2329,32638970,Physical activity impact on motor development and oxidative stress biomarkers in school children with intellectual disability.,"OBJECTIVE Lower physical fitness and poor motor performance were shown to be linked with higher levels of oxidative stress in children and adolescents with intellectual disabilities. Therefore, a moderate aerobic exercise for 12-weeks was performed to evaluate the effects of physical activity scores on motor functions, oxidative stress, and intelligence quotients (IQ) in school children with intellectual disability. METHODS A total of 65 school children aged (12-18 Yrs) were randomly included in this study. Intellectual disability (ID),motor skills,physical fitness(VO2max), total energy expenditure (TEE), MDA, 8-OHdG, TAC, NO, and total oxidative stress(OS)were assessed using pre-validated WISC-IQ score test, BOT-2 test, PA questionnaire, and immunoassay techniques respectively. RESULTS WISC-IQ and BOT-2 set scores of intellectual and motor skills performance showed a significant correlation with physical activity status and the regulation of oxidative stress-free radicals in school children with mild and moderate ID following 12 weeks of moderate exercise. The intellectual and motor skills performance of the participants correlated positively with the increase in TAC activity and physical fitness scores and negatively with MDA, 8-OHdG, NO, and Total-OS, respectively. Stepwise multiple regression analysis of the demographic, physical status and oxidative stress parameters explained around78.0 to 93.4 % of intellectual disability variation among schoolchildren. CONCLUSION Moderate aerobic training for12 weeks has a positive impact on improving intellectual ability of schoolchildren with ID via modulating redox status, improves physical fitness, and motor skills proficiency.",2020,RESULTS WISC-IQ and BOT-2 set scores of intellectual and motor skills performance showed a significant correlation with physical activity status and the regulation of oxidative stress-free radicals in school children with mild and moderate ID following 12 weeks of moderate exercise.,"['children and adolescents with intellectual disabilities', 'school children with intellectual disability', 'A total of 65 school children aged (12-18 Yrs']",['Moderate aerobic training'],"['TAC activity and physical fitness scores and negatively with MDA, 8-OHdG, NO, and Total-OS', 'oxidative stress', 'motor development and oxidative stress biomarkers', 'physical activity scores on motor functions, oxidative stress, and intelligence quotients (IQ', 'WISC-IQ and BOT-2 set scores of intellectual and motor skills performance', 'intellectual and motor skills performance', 'Intellectual disability (ID),motor skills,physical fitness(VO2max), total energy expenditure (TEE), MDA, 8-OHdG, TAC, NO, and total oxidative stress(OS)were assessed using pre-validated WISC-IQ score test, BOT-2 test, PA questionnaire, and immunoassay techniques respectively']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4511829', 'cui_str': 'Immunoassay technique'}]",65.0,0.0347272,RESULTS WISC-IQ and BOT-2 set scores of intellectual and motor skills performance showed a significant correlation with physical activity status and the regulation of oxidative stress-free radicals in school children with mild and moderate ID following 12 weeks of moderate exercise.,"[{'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, KSA.'}, {'ForeName': 'Sami A', 'Initials': 'SA', 'LastName': 'Gabr', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, KSA.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.5.600']
2330,32638976,Comparison of the effect of two internal fixation methods for proximal clavicle fractures.,"OBJECTIVE To compare the effect of two internal fixation methods in the treatment of proximal clavicle fractures. METHODS Fifty patients with proximal clavicle fractures received surgical treatment. They were divided into a clavicular T-plate group and a double mini-plates group. The duration of the operation, blood loss during the operation, fracture healing time, and incision infection were evaluated between the two groups. RESULTS Operation time (t=2.063, P=0.058), intraoperative bleeding (t=1.979, P=0.062), and fracture healing time (t=1.082, P=0.066) were not statistically significant in the two groups. The patients were followed up for 12-18 months; one patient in the T-plate group had early removal of nails, but no clinical symptoms. At the 2-month follow-up, the ASES score in the double mini-plates group was significantly better than in the T-plate group (P<0.001); but at the 6-month follow-up, 1-week before removal of internal fixation and the final follow-up, the two groups had no significant differences (P>0.05). CONCLUSIONS Both internal fixations have similar clinical results in the duration of operation, blood loss during the operation, and fracture healing time. The double mini-plates fixation presents advantages by reducing complications and speeding fracture healing; thus it is a more effective method to treat proximal clavicle fractures.",2020,"Both internal fixations have similar clinical results in the duration of operation, blood loss during the operation, and fracture healing time.","['proximal clavicle fractures', 'Fifty patients with proximal clavicle fractures received']","['clavicular T-plate group and a double mini-plates group', 'surgical treatment', 'internal fixation methods']","['early removal of nails', 'intraoperative bleeding', 'duration of the operation, blood loss during the operation, fracture healing time, and incision infection', 'ASES score', 'fracture healing time', 'Operation time']","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0191722', 'cui_str': 'Removal of nail'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0142053,"Both internal fixations have similar clinical results in the duration of operation, blood loss during the operation, and fracture healing time.","[{'ForeName': 'Haining', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': ""Department of Orthopaedics, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Orthopaedics, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Sui', 'Affiliation': ""Department of Orthopaedics, Dongying People's Hospital, Dongying, Shandong, China.""}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.5.654']
2331,32638995,Cost-effectiveness of a preventive self-care health management program for community-dwelling older adults: a randomised controlled trial.,"OBJECTIVE


To examine the cost-effectiveness of a preventive self-care health management program for community-dwelling older adults as compared to usual care.
DESIGN/INTERVENTION


A cost-effectiveness analysis was executed alongside a randomised controlled trial. Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students. The control group received social control calls.
PARTICIPANTS/SETTING


Community-dwelling older adults were randomly assigned to the intervention (n = 271) or control (n = 269) group. The intervention was conducted in collaboration with 11 community centres under four non-government organisations in various districts of Hong Kong.
MEASUREMENTS


Cost and quality-adjusted life years (QALYs) were collected pre (baseline, 0 months) and post intervention (3 months) and 3 months after completion of the program (6 months). Incremental cost-effectiveness ratios between the groups were calculated, dividing the difference in cost by the difference in QALYs.
RESULTS


Analysis showed that the net incremental QALY gain was 0.0014 (3 months) and 0.0033 (6 months) when the intervention group was compared to the control group. The probability of being cost-effective at 6 months was 53.2% and 53.4%, based on the cost-effectiveness thresholds recommended by both the National Institute for Health and Clinical Excellence ($200,000/QALYs) and the World Health Organization (Hong Kong gross domestic product/capita, HK$381,780).
CONCLUSIONS


The results provide some evidence to suggest that the addition of a home-based, preventive self-care health management program may have effects on cost outcomes for community-dwelling older adults in Hong Kong.",2020,"Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students.","['Community-dwelling older adults', 'community-dwelling older adults', 'community-dwelling older adults in Hong Kong', '11 community centres under four non-government organisations in various districts of Hong Kong']","['preventive self-care health management program', 'social control calls']","['Cost-effectiveness', 'probability of being cost-effective', 'Cost and quality-adjusted life years (QALYs', 'Incremental cost-effectiveness ratios', 'cost-effectiveness', 'net incremental QALY gain']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037405', 'cui_str': 'Social Control'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",,0.0354808,"Nurse case managers provided interventions, including holistic assessment, empowerment of self-care, preventive health behaviours and self-efficacy with co-produced care planning, supported by nursing students.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Ching', 'Initials': 'C', 'LastName': 'So', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Age and ageing,['10.1093/ageing/afaa127']
2332,32634064,"Wound complications after total hip arthroplasty: a prospective, randomised controlled trial comparing staples with sutures.","OBJECTIVE


Does the use of staples or sutures for wound closure have a lower surgical site infection rate in patients receiving primary total hip arthroplasty (THA)?
DESIGN


Prospective, randomised controlled multicentre trial.
METHODS


535 patients undergoing THA were included and randomised into 2 groups: 268 wounds were closed with staples, and 267 with sutures. Primary outcome was surgical site infection (SSI). Secondary outcomes were prosthetic joint infection (PJI), other wound complications (dehiscence, necrosis and prolonged drainage) and duration of admittance. Follow-up occurred at 2, 6, and 12 weeks, and at 1 year.
RESULTS


There were no significant demographic differences between the 2 groups. SSI occurred more frequently when wounds were closed with staples (4% compared to 1% with sutures; OR 2.8; CI, 0.885-0.952;  p  = 0.057). SSI was treated with oral antibiotics. The staples group showed significantly more wound complications (17% compared to 5%; OR 3.943, CI 2.073-7.498;  p  = 0.000). Wound discharge was significantly prolonged in the staples group ( n  = 40, compared to  n  = 12 in the sutures group; OR 3.728; CI, 1.909-7.281;  p  = 0.000). There was no significant difference in PJI ( p  = 0.364).
CONCLUSIONS


In this large RCT comparing staples with sutures after THA, the use of staples is associated with a nearly 3 times greater risk of SSI (OR 2.8;  p  = 0.057). Staples significantly prolong wound discharge. The use of sutures for wound closure after THA is advised.  Trial registration:  Staples Or Sutures trial (S.O.S. trial) http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3946 , NTR3946.",2020,"Wound discharge was significantly prolonged in the staples group ( n  = 40, compared to  n  = 12 in the sutures group; OR 3.728; CI, 1.909-7.281;  p  = 0.000).","['535 patients undergoing THA were included and randomised into 2 groups', '268 wounds were closed with staples, and 267 with sutures', 'patients receiving primary total hip arthroplasty (THA', 'total hip arthroplasty']","['staples or sutures', 'oral antibiotics']","['prosthetic joint infection (PJI), other wound complications (dehiscence, necrosis and prolonged drainage) and duration of admittance', 'Wound complications', 'wound complications', 'SSI', 'PJI', 'surgical site infection (SSI', 'wound discharge', 'Wound discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}]",535.0,0.157384,"Wound discharge was significantly prolonged in the staples group ( n  = 40, compared to  n  = 12 in the sutures group; OR 3.728; CI, 1.909-7.281;  p  = 0.000).","[{'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'Mallee', 'Affiliation': 'Department of Orthopaedic surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Wijsbek', 'Affiliation': 'Department of Orthopaedic surgery, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Schafroth', 'Affiliation': 'Department of Orthopaedic surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Wolkenfelt', 'Affiliation': 'Department of Orthopaedic surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Dominique C', 'Initials': 'DC', 'LastName': 'Baas', 'Affiliation': 'Department of Orthopaedic surgery, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Ton M J S', 'Initials': 'TMJS', 'LastName': 'Vervest', 'Affiliation': 'Department of Orthopaedic surgery, Tergooi Hospital, Hilversum, The Netherlands.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020939075']
2333,32634172,Optimal paramedic numbers in resuscitation of patients with out-of-hospital cardiac arrest: A randomized controlled study in a simulation setting.,"BACKGROUND


The effect of paramedic crew size in the resuscitation of patients with out-of-hospital cardiac arrest (OHCA) remains inconclusive. We hypothesised that teams with a larger crew size have better resuscitation performance including chest compression fraction (CCF), advanced life support (ALS), and teamwork performance than those with a smaller crew size.
METHODS


We conducted a randomized controlled study in a simulation setting. A total of 140 paramedics from New Taipei City were obtained by stratified sampling and were randomly allocated to 35 teams with crew sizes of 2, 3, 4, 5, and 6 (i.e. 7 teams in every paramedic crew size). A scenario involving an OHCA patient who experienced ventricular fibrillation and was attached to a cardiopulmonary resuscitation (CPR) machine was simulated. The primary outcome was the overall CCF; the secondary outcomes were the CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance. Tasks affecting the hands-off time during CPR were also analysed.
RESULTS


In all 35 teams with crew sizes of 2, 3, 4, 5, and 6, the overall CCFs were 65.1%, 64.4%, 70.7%, 72.8%, and 71.5%, respectively (P = 0.148). Teams with a crew size of 5 (58.4%, 61.8%, 68.9%, 72.4%, and 68.7%, P<0.05) had higher CCF in manual CPR periods and better team dynamics. Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics. Troubleshooting of M-CPR machine decreased the hands-off time during resuscitation (39 s), with teams comprising 2 paramedics having the longest hands-off time (63s).
CONCLUSION


Larger paramedic crew size (≧4 paramedics) did not significantly increase the overall CCF in OHCA resuscitation but showed higher CCF in manual CPR period before the setup of the CPR machine. A crew size of ≧4 paramedics can also shorten the time of ALS interventions, while teams with 5 paramedics will have the best teamwork performance. Paramedic teams with a smaller crew size should focus more on the quality of manual CPR, teamwork, and training how to troubleshoot a M-CPR machine.",2020,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","['A total of 140 paramedics from New Taipei City', 'patients with out-of-hospital cardiac arrest (OHCA', 'patients with out-of-hospital cardiac arrest']","['M-CPR machine', 'epinephrine']","['overall CCF', 'chest compression fraction (CCF), advanced life support (ALS), and teamwork performance', 'CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance', 'overall CCFs', 'overall CCF in OHCA resuscitation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",140.0,0.0659625,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","[{'ForeName': 'Bing Min', 'Initials': 'BM', 'LastName': 'Tsai', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Jen-Tang', 'Initials': 'JT', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Yu-You', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Tsung-Chi', 'Initials': 'TC', 'LastName': 'Kao', 'Affiliation': 'Division Chief of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Lee-Wei', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Institute of Emergency and Critical Care Medicine, National Yang Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Matthew Huei-Ming', 'Initials': 'MH', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Wen-Chu', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}]",PloS one,['10.1371/journal.pone.0235315']
2334,32643561,Effects of a School-Based Intervention on Motivation for Out-of-School Physical Activity Participation.,"Purpose : We tested the effects of an autonomy-supportive intervention in physical education (PE) on high-school students' autonomous motivation in PE, and their autonomous motivation, intentions, and physical activity (PA) behavior in a leisure time guided by the trans-contextual model.  Method : PE classes in two schools were assigned to receive either an autonomy-supportive intervention and/or a control intervention via random allocation by the school. The PE teacher of the school assigned to the autonomy-supportive intervention was trained to provide autonomy support while the PE teacher of the school assigned to the control intervention received no training. Students ( N  = 256) in all classes completed measures of perceived teacher autonomy support, autonomous motivation in PE and leisure time, and beliefs, intentions, and PA in leisure time before and immediately after the intervention.  Results : Results revealed direct effects of the autonomy-supportive intervention on changes in perceived autonomy support. However, there were no direct intervention effects on change in intentions and PA behavior. The intervention also had indirect effects on changes in autonomous motivation in PE and leisure time. Additionally, change in perceived autonomy support had direct effects on change in autonomous motivation in PE and indirect effects on change in leisure-time autonomous motivation. Changes in autonomous motivation in leisure time had direct effects on changes in beliefs and indirect effects on changes in intentions and PA behavior through changes in beliefs.  Conclusion : The study provides valuable information on the effect of autonomous supportive climate on students' beliefs toward PA in PE lessons and in their leisure time outside of school.",2020,Changes in autonomous motivation in leisure time had direct effects on changes in beliefs and indirect effects on changes in intentions and PA behavior through changes in beliefs.  ,"[""students' beliefs toward PA in PE lessons and in their leisure time outside of school"", 'high-school students']","['control intervention received no training', 'autonomy-supportive intervention and/or a control intervention via random allocation by the school', 'autonomy-supportive intervention in physical education (PE', 'School-Based Intervention']","['intentions and PA behavior', 'perceived teacher autonomy support, autonomous motivation in PE and leisure\xa0time, and beliefs, intentions, and PA in leisure\xa0time', 'autonomous motivation in PE, and their autonomous motivation, intentions, and physical activity (PA) behavior', 'autonomous motivation in PE and leisure time']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",2.0,0.0172134,Changes in autonomous motivation in leisure time had direct effects on changes in beliefs and indirect effects on changes in intentions and PA behavior through changes in beliefs.  ,"[{'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Barkoukis', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Chatzisarantis', 'Affiliation': 'Curtin University.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'University of California , Merced.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1751029']
2335,32643674,"Effect of Stellate Ganglion Block on Intraoperative Propofol and Fentanyl Consumption in Patients with Complex Regional Pain Syndrome Undergoing Surgical Repair of Brachial Plexus Injury: A Randomized, Double-blind, Placebo-controlled Trial.","Introduction


Stellate ganglion block (SGB) is commonly performed to treat chronic painful conditions, such as complex regional pain syndrome (CRPS) and postherpetic neuralgia. However, whether it is effective in reducing anesthesia and analgesia requirement during surgery (acute pain) is not known.
Materials and Methods


Sixty American Society of Anesthesiologists (ASA) physical status I and II patients with CRPS type II undergoing surgery for repair of brachial plexus injury were randomized (1:1) to receive SGB with either 10 mL of 0.5% bupivacaine (Group B) or a matching placebo (Group S) before induction of anesthesia.
Results


There was a significant reduction in the requirement of total intraoperative propofol (1659.7 ± 787.5 vs. 2500.7 ± 740.9 mg, P = 0.0003) and fentanyl (190.0 ± 82.5 vs. 327.3 ± 139.3, P = 0.0001) in Group B compared with Group S. Similarly, in Group B, the time to first analgesic was much longer (328 ± 219 vs. 64 ± 116 min, P = 0.000) and postoperative fentanyl requirement for 24 h was lesser compared to Group S (0.6 ± 1.1 vs. 2.1 ± 1.3 μg/kg, P = 0.000).
Conclusion


SGB is effective in reducing the requirement of intraoperative propofol and fentanyl as well as decreasing opioid requirement in the postoperative period in patients with CRPS type II undergoing surgery.",2020,"There was a significant reduction in the requirement of total intraoperative propofol (1659.7 ± 787.5 vs. 2500.7 ± 740.9 mg, P = 0.0003) and fentanyl (190.0 ± 82.5 vs. 327.3 ± 139.3, P = 0.0001) in Group B compared with Group S. Similarly, in Group B, the time to first analgesic was much longer (328 ± 219 vs. 64 ± 116 min, P = 0.000) and postoperative fentanyl requirement for 24 h was lesser compared to Group S (0.6 ± 1.1 vs. 2.1 ± 1.3 μg/kg, P = 0.000).
","['I and II patients with CRPS type II undergoing surgery for repair of brachial plexus injury', 'patients with CRPS type II undergoing surgery', 'Sixty American Society of Anesthesiologists (ASA', 'Patients with Complex Regional Pain Syndrome', 'Undergoing Surgical Repair of Brachial Plexus Injury']","['SGB with either 10 mL of 0.5% bupivacaine', 'Intraoperative Propofol and Fentanyl Consumption', 'Placebo', 'Introduction\n\n\nStellate ganglion block (SGB', 'matching placebo', 'Stellate Ganglion Block']","['postoperative fentanyl requirement', 'physical status', 'requirement of total intraoperative propofol', 'time to first analgesic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007462', 'cui_str': 'Complex regional pain syndrome, type II'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0161446', 'cui_str': 'Injury of brachial plexus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",60.0,0.265069,"There was a significant reduction in the requirement of total intraoperative propofol (1659.7 ± 787.5 vs. 2500.7 ± 740.9 mg, P = 0.0003) and fentanyl (190.0 ± 82.5 vs. 327.3 ± 139.3, P = 0.0001) in Group B compared with Group S. Similarly, in Group B, the time to first analgesic was much longer (328 ± 219 vs. 64 ± 116 min, P = 0.000) and postoperative fentanyl requirement for 24 h was lesser compared to Group S (0.6 ± 1.1 vs. 2.1 ± 1.3 μg/kg, P = 0.000).
","[{'ForeName': 'Vanitha', 'Initials': 'V', 'LastName': 'Rajagopalan', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajendra Singh', 'Initials': 'RS', 'LastName': 'Chouhan', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mihir Prakash', 'Initials': 'MP', 'LastName': 'Pandia', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Lamsal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, National Academy of Medical Sciences, Kathmandu, Nepal.'}, {'ForeName': 'Parmod Kumar', 'Initials': 'PK', 'LastName': 'Bithal', 'Affiliation': 'Department of Anesthesia, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Girija Prasad', 'Initials': 'GP', 'LastName': 'Rath', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Neurology India,['10.4103/0028-3886.288992']
2336,32643857,Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials.,"The randomized, double-blind cardiovascular outcomes trials LEADER (NCT01179048) and SUSTAIN 6 (NCT01720446) demonstrated cardiovascular risk reduction in patients with type 2 diabetes treated with liraglutide and semaglutide, respectively, compared with placebo. This post hoc analysis examined the impact of microvascular disease at baseline on cardiovascular outcomes in these trials, and the efficacy of liraglutide (1.8 mg) and once-weekly semaglutide (0.5-1.0 mg) in patients with and without microvascular disease. In total, 9340 patients from LEADER and 3297 patients from SUSTAIN 6 were included in this analysis; of these, 5761 and 2356 had a history of microvascular disease at baseline and 3835 and 1640 had a history of both microvascular and macrovascular disease, respectively. Patients with microvascular disease were shown to have increased risk of major adverse cardiovascular events (MACE) compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03;1.29] p = 0.0136; SUSTAIN 6: 1.56 [1.14;2.17] p = 0.0064). Liraglutide and semaglutide consistently reduced cardiovascular risk in patients with and without microvascular disease.",2020,Patients with microvascular disease were shown to have increased risk of major adverse cardiovascular events (MACE) compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03;1.29],"['9340 patients from LEADER and 3297 patients from SUSTAIN 6 were included in this analysis; of these, 5761 and 2356 had a history of microvascular disease at baseline and 3835 and 1640 had a history of both microvascular and macrovascular disease, respectively', 'patients with type 2 diabetes treated with liraglutide and semaglutide, respectively, compared with', 'Patients with microvascular disease', 'patients with and without microvascular disease', 'type 2 diabetes']","['liraglutide', 'Liraglutide', 'placebo']","['risk of major adverse cardiovascular events (MACE', 'cardiovascular risk reduction', 'cardiovascular risk', 'cardiovascular outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2609253', 'cui_str': 'Macrovascular disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",9340.0,0.266225,Patients with microvascular disease were shown to have increased risk of major adverse cardiovascular events (MACE) compared with patients without microvascular disease (hazard ratio [95% confidence interval] in LEADER: 1.15 [1.03;1.29],"[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, UK.'}, {'ForeName': 'Julie Broe', 'Initials': 'JB', 'LastName': 'Honoré', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, and Dept. of Nephrology, Friedrich Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sejersten Ripa', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14140']
2337,32643884,[Effect of electrical stimulation with bilateral scalp acupuncture on time parameters in video fluoroscopic swallowing study and cortical excitability in patients with dysphagia after cortical stroke].,"OBJECTIVE


To investigate the effect of electrical stimulation with bilateral scalp acupuncture on time parameters in video fluoroscopic swallowing study and cortical excitability in patients with dysphagia after cortical stroke, as well as its possible mechanism of action.
METHODS


A total of 84 patients with dysphagia after cortical stroke were randomly divided into control group with 41 patients and observation group with 43 patients. The patients in the control group were given acupuncture based on acupoint selection for pseudobulbar palsy, and in addition to the treatment in the control group, the patients in the observation group were given electrical stimulation of bilateral scalp acupuncture, with acupuncture and pulse acupuncture at the lower 2/5 of the bilateral anterior oblique parietotemporal lines[on the line connecting Qianshencong (EX-HN1) to Xuanli (GB6)] and the lower 2/5 of the bilateral posterior oblique parietotemporal lines [on the line connecting Baihui (GV20)and Qubin (GB7)], with a needle retaining time of 30 minutes, once a day and 6 times a week for 3 weeks. Before treatment and after 3 weeks of treatment, oral delay time (ODT), oral transit time (OTT), pharyngeal delay time (PDT), and pharyngeal transit time (PTT) were compared between the two group; the Rosenbek Penetration-Aspiration Scale was used to evaluate penetration-aspiration and appro-ximate entropy (ApEn) of EEG nonlinear index.
RESULTS


After treatment, both groups had significant reductions in ODT, OTT, PDT, PTT, and Rosenbek Penetration-Aspiration score and a significant increase in ApEn ( P <0.05). Compared with the control group after treatment, the observation group had significant reductions in ODT and OTT ( P <0.05) and significant increases in the ApEn values of bilateral central, parietal, and posterior temporal regions ( P <0.05), while there were no significant differences in PDT, PTT, and Rosenbek Penetration-Aspiration score between the two groups ( P >0.05).
CONCLUSION


In addition to body acupuncture, electrical stimulation with bilateral scalp acupuncture can improve ODT and OTT in the treatment of patients with dysphagia after cortical stroke, which may be associated with the increased excitability of the swallowing cortex.",2020,"Compared with the control group after treatment, the observation group had significant reductions in ODT and OTT ( P <0.05) and significant increases in the ApEn values of bilateral central, parietal, and posterior temporal regions ( P <0.05), while there were no significant differences in PDT, PTT, and Rosenbek Penetration-Aspiration score between the two groups ( P >0.05).
","['41 patients and observation group with 43 patients', 'patients with dysphagia after cortical stroke', '84 patients with dysphagia after cortical stroke']","['electrical stimulation with bilateral scalp acupuncture', 'electrical stimulation of bilateral scalp acupuncture, with acupuncture and pulse acupuncture at the lower 2/5 of the bilateral anterior oblique parietotemporal lines[on the line connecting Qianshencong (EX-HN1) to Xuanli (GB6)] and the lower 2/5 of the bilateral posterior oblique parietotemporal lines [on the line connecting Baihui (GV20)and Qubin (GB7', 'bilateral scalp acupuncture', 'acupuncture based on acupoint selection']","['penetration-aspiration and appro-ximate entropy (ApEn) of EEG nonlinear index', 'ODT and OTT', 'ApEn values of bilateral central, parietal, and posterior temporal regions', 'PDT, PTT, and Rosenbek Penetration-Aspiration score', 'Rosenbek Penetration-Aspiration Scale', 'ODT, OTT, PDT, PTT, and Rosenbek Penetration-Aspiration score', 'oral delay time (ODT), oral transit time (OTT), pharyngeal delay time (PDT), and pharyngeal transit time (PTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1335068', 'cui_str': 'NOTCH1 protein, human'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0450728', 'cui_str': 'GB7'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.0334409,"Compared with the control group after treatment, the observation group had significant reductions in ODT and OTT ( P <0.05) and significant increases in the ApEn values of bilateral central, parietal, and posterior temporal regions ( P <0.05), while there were no significant differences in PDT, PTT, and Rosenbek Penetration-Aspiration score between the two groups ( P >0.05).
","[{'ForeName': 'Hai-Peng', 'Initials': 'HP', 'LastName': 'Jin', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Xiamen Hospital of Beijing University of Chinese Medicine, Xiamen 361009, Fujian Province, China.'}, {'ForeName': 'Xiang-Liang', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Xiamen Hospital of Beijing University of Chinese Medicine, Xiamen 361009, Fujian Province, China.'}, {'ForeName': 'Qing-Jing', 'Initials': 'QJ', 'LastName': 'Ye', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Xiamen Hospital of Beijing University of Chinese Medicine, Xiamen 361009, Fujian Province, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Xiamen Hospital of Beijing University of Chinese Medicine, Xiamen 361009, Fujian Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190697']
2338,32644127,"Safety, pharmacokinetics and causal prophylactic efficacy of KAF156 in a Plasmodium falciparum human infection study.","BACKGROUND


KAF156 is a novel antimalarial drug that is active against both liver- and blood- stage Plasmodium parasites, including drug-resistant strains. Here, we investigated the causal prophylactic efficacy of KAF156 in a controlled human malaria infection (CHMI) model.
METHODS


In Part 1, healthy, malaria-naïve participants received 800 mg KAF156 or placebo three hr before CHMI with Pf-infected mosquitoes. In Part 2, KAF156 was administered as single doses of 800, 300, 100, 50, or 20 mg 21 hr post-CHMI. All participants received atovaquone/proguanil treatment if blood-stage infection was detected or on day 29. For each cohort, 7-14 subjects were enrolled to KAF156 treatment and up to four subjects to placebo.
RESULTS


KAF156 at all dose levels was safe and well tolerated. Two serious adverse events were reported - both resolved without sequelae and neither was considered related to KAF156. In Part 1, all participants treated with KAF156 and none of those randomized to placebo were protected against malaria infection. In Part 2, all participants treated with placebo or 20 mg KAF156 developed malaria infection. In contrast, 50 mg KAF156 protected 3/14 participants from infection, and doses of 800, 300, and 100 mg KAF156 protected all subjects against infection. An exposure-response analysis suggested that a 24-hr post-dose concentration of KAF156 of 21·5 ng/mL (90% CI 17.66 to 25.32 ng/mL) would ensure a 95% chance of protection from malaria parasite infection.
CONCLUSIONS


KAF156 was safe and well tolerated and demonstrated high levels of pre- and post-CHMI protective efficacy.",2020,"In Part 1, all participants treated with KAF156 and none of those randomized to placebo were protected against malaria infection.",[],"['KAF156', 'KAF156 or placebo', 'atovaquone/proguanil treatment', 'placebo']","['Safety, pharmacokinetics and causal prophylactic efficacy', 'malaria infection', 'safe and well tolerated']",[],"[{'cui': 'C4043264', 'cui_str': 'KAF156'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0939219', 'cui_str': 'Atovaquone- and proguanil-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",14.0,0.148962,"In Part 1, all participants treated with KAF156 and none of those randomized to placebo were protected against malaria infection.","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Seattle Malaria Clinical Trials Center, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Murphy', 'Affiliation': 'Departments of Laboratory Medicine and Microbiology and the Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Seilie', 'Affiliation': 'Departments of Laboratory Medicine and Microbiology and the Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jay Prakash', 'Initials': 'JP', 'LastName': 'Jain', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berger', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Spera', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Soon', 'Affiliation': 'Novartis Pharmaceuticals, Health Plaza, East Hanover, NJ.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Czartoski', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Potochnic', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Duke', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Departments of Laboratory Medicine and Microbiology and the Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Stefan H I', 'Initials': 'SHI', 'LastName': 'Kappe', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'F Joel', 'Initials': 'FJ', 'LastName': 'Leong', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pertel', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Prince', 'Affiliation': 'Novartis Institutes for BioMedical Research, Emeryville, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa952']
2339,32644148,Evaluation of Month-24 Efficacy and Safety of Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration: The MERLOT Randomized Clinical Trial.,"Importance


Although anti-vascular endothelial growth factor (VEGF) treatment offers better outcomes than the natural history of neovascular age-related macular degeneration (ARMD), a less burdensome, less expensive, and more durable treatment is needed.
Objective


To assess the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular ARMD.
Design, Setting, and Participants


The Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) pivotal device trial was conducted at 24 National Health Service hospitals across the UK. Patients who had neovascular ARMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible patients were randomized 2:1 and were stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at a final visit at month 36. Masking of participants and clinicians was not possible, but best-corrected visual acuity (BCVA) and imaging were analyzed by masked assessors. Analysis followed the intent-to-treat approach.
Interventions


Pars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs as-needed ranibizumab monotherapy.
Main Outcomes and Measures


Coprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography.
Results


Of 363 participants, 329 (90.6%) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean (SD) age of the combined groups was 76.5 (7.4) years. The mean (SD) number of ranibizumab injections was 9.3 (6.7) in the EMB group and 8.3 (4.5) in the ranibizumab group, with a difference of 1.0 injection (95% CI, -0.3 to 2.3; P = .13). The mean (SD) BCVA change was -11.2 (15.7) ETDRS letters in the EMB group and -1.4 (10.9) ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (95% CI, -6.7 to -12.9). In the EMB group, 65.6% of participants (160 of 244) lost fewer than 15 ETDRS letters vs 86.6% (103 of 119) in the ranibizumab group, with a difference of 21% (95% CI, 12.4%-29.5%; P < .001). Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns.
Conclusions and Relevance


The MERLOT trial found that despite the acceptable safety of EMB, it did not reduce the number of ranibizumab injections and was associated with worse visual acuity than anti-VEGF treatment alone; these results do not support EMB use as an adjunct treatment for chronic, active neovascular ARMD.
Trial Registration


ClinicalTrials.gov Identifier: NCT01006538.",2020,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"['24 National Health Service hospitals across the UK', 'Patients who had neovascular ARMD and received', '363 participants, 329 (90.6', 'Eligible patients', 'Previously Treated Neovascular Age-Related Macular Degeneration']","['Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis', 'EMB', 'ranibizumab', 'Epimacular Brachytherapy', 'epimacular brachytherapy (EMB', 'intravitreal ranibizumab', 'Interventions\n\n\nPars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab', 'anti-vascular endothelial growth factor (VEGF) treatment', 'EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy']","['visual acuity', 'percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters', 'mean (SD) number of ranibizumab injections', 'angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography', 'Microvascular abnormalities', 'efficacy and safety', 'number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters', 'mean (SD) BCVA change']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.358324,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Jackson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Soare', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Neffendorf', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Reading Center, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Membrey', 'Affiliation': 'Department of Ophthalmology, Maidstone Hospital, Maidstone, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Department of Ophthalmology, Bristol Eye Hospital, Bristol, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Costen', 'Affiliation': 'Department of Ophthalmology, Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steel', 'Affiliation': 'Vitreoretinal Unit, Sunderland Eye Infirmary, Sunderland, United Kingdom.'}, {'ForeName': 'Riti', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2309']
2340,32644264,Effects of Advanced Carbohydrate Counting on Glucose Control and Quality of Life in Children with Type 1 Diabetes.,"OBJECTIVE


The effect of advanced carbohydrate counting (ACC) on metabolic and quality of life (QOL) outcomes is uncertain in children with type 1 diabetes. Our aim was to determine whether ACC would improve HbA1c and QOL scores as compared with standard nutrition in this population.
METHODS


We randomized 87 patients using pump and rapid-acting analogs in a 1-year randomized multi-center study (age 9.6±3.5 yr, diabetes duration 4.6±2.7 yr, HbA1c 7.8±0.5% [62±5 mmol/mol]). The ACC group received CC education and the control group received traditional dietary education. HbA1c was measured every 3 months. At 0 and 1 year, general, diabetes-specific, and diet-related QOL were respectively assessed by the KIDSCREEN and WHO-5 questionnaires, the diabetes-specific module of the DISABKIDS, and the diet restriction items of the DSQOL.
RESULTS


Mean HbA1c was lower in the ACC than the control group at 3 months (p<0.05) and tended to be lower at 6 months (p=0.10), 9 months (p = 0.10), but not at 12 months. The mean of individual average HbA1c during the one-year study period (from M3 to M12) was 7.63±0.43 in the ACC vs. 7.85±0.47% in the control group [60±5 vs. 62±5 mmol/mol](p<0.05). ACC was associated with significantly higher scores at 1 year on the KIDSCREEN children's psychological scale and the KIDSCREEN parents' physical scale, the DISABKIDS children's treatment scale, and the children's and parents' dietary restriction scales of the DSQOL (indicating better QOL or lower perceived diet restriction).
CONCLUSIONS


ACC may be associated with small improvements in metabolic control and QOL scores in children. This article is protected by copyright. All rights reserved.",2020,"Mean HbA1c was lower in the ACC than the control group at 3 months (p<0.05) and tended to be lower at 6 months (p=0.10), 9 months (p = 0.10), but not at 12 months.","['children with type 1 diabetes', 'Children with Type 1 Diabetes', '87 patients using pump and rapid-acting analogs in a 1-year randomized multi-center study (age 9.6±3.5 yr, diabetes duration 4.6±2.7 yr, HbA1c 7.8±0.5% [62±5\u2009mmol/mol', 'children']","['advanced carbohydrate counting (ACC', 'traditional dietary education', 'ACC', 'Advanced Carbohydrate Counting']","['metabolic and quality of life (QOL) outcomes', 'metabolic control and QOL scores', 'HbA1c and QOL scores', 'Mean HbA1c', 'Glucose Control and Quality of Life', 'mean of individual average HbA1c']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",87.0,0.0413799,"Mean HbA1c was lower in the ACC than the control group at 3 months (p<0.05) and tended to be lower at 6 months (p=0.10), 9 months (p = 0.10), but not at 12 months.","[{'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Donzeau', 'Affiliation': 'Pediatric Diabetology, University Hospital, Angers, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bonnemaison', 'Affiliation': 'Pediatric Diabetology, University Hospital, Tours, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Vautier', 'Affiliation': 'Pediatric Diabetology, University Hospital, Bordeaux, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Menut', 'Affiliation': 'Pediatric Diabetology, University Hospital, Nantes, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Houdon', 'Affiliation': 'Pediatric Diabetology, University Hospital, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bendelac', 'Affiliation': 'Pediatric Diabetology, University Hospital, Lyon, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Bismuth', 'Affiliation': 'Pediatric Diabetology, University Hospital, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Bouhours-Nouet', 'Affiliation': 'Pediatric Diabetology, University Hospital, Angers, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Quemener', 'Affiliation': 'Pediatric Diabetology, University Hospital, Angers, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Baron', 'Affiliation': 'Pediatric Diabetology, University Hospital, Nantes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nicolino', 'Affiliation': 'Pediatric Diabetology, University Hospital, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Faure', 'Affiliation': 'Pediatric Diabetology, University Hospital, Tours, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pochelu', 'Affiliation': 'Pediatric Diabetology, University Hospital, Bordeaux, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Barat', 'Affiliation': 'Pediatric Diabetology, University Hospital, Bordeaux, France.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Coutant', 'Affiliation': 'Pediatric Diabetology, University Hospital, Angers, France.'}]",Pediatric diabetes,['10.1111/pedi.13076']
2341,32644304,"Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial.","Wound-healing disorders are common complications in bilateral reduction mammaplasty. Traditional electrosurgical devices generate large amounts of thermal energy, often causing extensive thermal-related collateral tissue damage. This study aimed to retrospectively analyse the operative performance of a novel low-thermal plasma dissection device (pulsed electron avalanche knife-PEAK PlasmaBlade™) compared with traditional electrosurgery. Twenty patients with breast hypertrophy were randomly treated with PEAK PlasmaBlade™ on one breast and conventional electrosurgery on the other. Primary outcome measures were resection weight, drain duration, total drainage volume, and drain output on the first postoperative day. Breasts treated with PEAK PlasmaBlade™ had significantly higher resection weights (728.0 ± 460.1 g vs 661.6 ± 463.4 g; P = .038), significantly lower drain output on the first postoperative day (15.9 ± 15.2 mL vs 27.6 ± 23.5 mL; P = .023), and significantly lower drain durations (2.8 ± 1.0 days vs 3.3 ± 1.0 days; P = .030). Mean total drainage volume was lower where breast reduction was performed with PEAK PlasmaBlade™, but this difference was not significant. No major complications occurred, but wound-healing disorders were documented in almost one-third of the patients (35.0%, n = 7). The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.",2020,The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.,['Twenty patients with breast hypertrophy'],"['PEAK PlasmaBlade™ on one breast and conventional electrosurgery', 'Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery', 'traditional electrosurgery', 'novel low-thermal plasma dissection device (pulsed electron avalanche knife-PEAK PlasmaBlade™']","['drain output', 'Mean total drainage volume', 'resection weight, drain duration, total drainage volume, and drain output on the first postoperative day', 'resection weights', 'wound-healing disorders', 'tissue damage and wound healing', 'major complications', 'drain durations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020565', 'cui_str': 'Hypertrophy of breast'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0337014', 'cui_str': 'Avalanche'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2936479', 'cui_str': 'Thermal Plasma'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0373759,The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.,"[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schlosshauer', 'Affiliation': 'Department of Plastic, Aesthetic, Reconstructive and Hand Surgery, AGAPLESION Evangelical Hospital Central State of Hesse, Giessen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Kiehlmann', 'Affiliation': 'Department of Plastic and Aesthetic, Reconstructive and Hand Surgery, AGAPLESION Markus Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Rothenberger', 'Affiliation': 'Department of Plastic and Aesthetic, Reconstructive and Hand Surgery, AGAPLESION Markus Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sader', 'Affiliation': 'Department for Oral, Cranio-Maxillofacial and Facial Plastic Surgery, Medical Center of the Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Ulrich M', 'Initials': 'UM', 'LastName': 'Rieger', 'Affiliation': 'Department of Plastic and Aesthetic, Reconstructive and Hand Surgery, AGAPLESION Markus Hospital, Frankfurt am Main, Germany.'}]",International wound journal,['10.1111/iwj.13452']
2342,31972655,Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics.,"BACKGROUND


Remimazolam (CNS 7056) is a new ultra-short-acting benzodiazepine for intravenous sedation and anesthesia. Its pharmacokinetics and pharmacodynamics have been reported for bolus administration. This study aimed to investigate the pharmacokinetics and pharmacodynamics of remimazolam after continuous infusion.
METHODS


Twenty healthy male volunteers (20 to 38 yr, 64 to 99 kg) received remimazolam as continuous intravenous infusion of 5 mg/min for 5 min, 3 mg/min for the next 15 min, and 1 mg/min for further 15 min. Pharmacokinetics of remimazolam and its metabolite were determined from arterial plasma concentrations. Sedation was assessed using the Modified Observer's Assessment of Alertness and Sedation scale. Pharmacokinetic-pharmacodynamic modeling was performed by population analysis. Hemodynamics and the electrocardiogram were also investigated.
RESULTS


Pharmacokinetics was best described by a three-compartment model for remimazolam and a two-compartment model with transit compartment for the metabolite. Remimazolam showed a high clearance (1.15 ± 0.12 l/min, mean ± SD), a small steady-state volume of distribution (35.4 ± 4.2 l) and a short terminal half-life (70 ± 10 min). The simulated context-sensitive halftime after an infusion of 4 h was 6.8 ± 2.4 min. Loss of consciousness was observed 5 ± 1 min after start, and full alertness was regained 19 ± 7 min after stop of infusion. Pharmacodynamics of Modified Observer's Assessment of Alertness and Sedation score was best described by a sigmoid probability model with effect site compartment. The half-maximum effect site concentration for a Modified Observer's Assessment of Alertness and Sedation score less than or equal to 1 was 695 ± 239 ng/ml. The equilibration half-time between central and effect compartment was 2.7 ± 0.6 min. Mean arterial blood pressure decreased by 24 ± 6%, and heart rate increased by 28 ± 15%. Spontaneous breathing was maintained throughout the study. There was no significant prolongation of the QT interval of the electrocardiogram observed.
CONCLUSIONS


Remimazolam was characterized by a pharmacokinetic-pharmacodynamic profile with fast onset, fast recovery, and moderate hemodynamic side effects.",2020,"RESULTS


Pharmacokinetics was best described by a three-compartment model for remimazolam and a two-compartment model with transit compartment for the metabolite.","['Healthy Male Volunteers', 'Twenty healthy male volunteers (20 to 38 yr, 64 to 99 kg) received']","['remimazolam', 'Remimazolam', 'benzodiazepine', 'Remimazolam (CNS 7056']","['Loss of consciousness', 'heart rate', 'Mean arterial blood pressure', 'Spontaneous breathing', 'Alertness and Sedation score', 'QT interval of the electrocardiogram observed', ""Modified Observer's Assessment of Alertness and Sedation scale""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C1959558', 'cui_str': 'CNS 7056'}]","[{'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.024813,"RESULTS


Pharmacokinetics was best described by a three-compartment model for remimazolam and a two-compartment model with transit compartment for the metabolite.","[{'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schüttler', 'Affiliation': 'From the Department of Anesthesiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenried', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lerch', 'Affiliation': ''}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Fechner', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jeleazcov', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ihmsen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003103']
2343,31972657,Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part II. Pharmacodynamics of Electroencephalogram Effects.,"BACKGROUND


Remimazolam (CNS 7056) is a new ultra-short acting benzodiazepine for IV sedation. This study aimed to investigate the electroencephalogram (EEG) pharmacodynamics of remimazolam infusion.
METHODS


Twenty healthy male volunteers received remimazolam as continuous IV infusion of 5 mg/min for 5 min, 3 mg/min for the next 15 min, and 1 mg/min for further 15 min. Continuous EEG monitoring was performed by a neurophysiologic system with electrodes placed at F3, F4, C3, C4, O1, O2, Cz, and Fp1 (10/20 system) and using the Narcotrend Index. Sedation was assessed clinically by using the Modified Observer's Assessment of Alertness and Sedation scale. Pharmacodynamic models were developed for selected EEG variables and Narcotrend Index.
RESULTS


EEG changes during remimazolam infusion were characterized by an initial increase in beta frequency band and a late increase in delta frequency band. The EEG beta ratio showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.79, and could be modeled successfully using a standard sigmoid Emax model. Narcotrend Index showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.74. The time course of Narcotrend Index was described by an extended sigmoid Emax model with two sigmoid terms and different plasma-effect equilibration times.
CONCLUSIONS


Beta ratio was identified as a suitable EEG variable for monitoring remimazolam sedation. Narcotrend Index appeared less suitable than the beta ratio for monitoring the sedative effect if remimazolam is administered alone.",2020,Narcotrend Index showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.74.,"['Healthy Male Volunteers', 'Twenty healthy male volunteers']","['remimazolam', 'remimazolam infusion', 'benzodiazepine', 'Remimazolam (CNS 7056']","[""prediction probability of Modified Observer's Assessment of Alertness and Sedation score"", 'time course of Narcotrend Index', 'electroencephalogram (EEG) pharmacodynamics', ""Modified Observer's Assessment of Alertness and Sedation scale""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C1959558', 'cui_str': 'CNS 7056'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.0181135,Narcotrend Index showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.74.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenried', 'Affiliation': 'From the Department of Anesthesiology, University Hospital Erlangen, University of Erlangen-Nuremberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schüttler', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lerch', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ihmsen', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jeleazcov', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003102']
2344,30402720,Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus.,"BACKGROUND


Fast-acting insulin aspart (faster aspart) is an ultra-fast-acting formulation of insulin aspart (IAsp). This post hoc analysis investigated the pharmacokinetics of faster aspart versus IAsp, measured as free or total IAsp, and the relationship between anti-IAsp antibodies and the pharmacokinetics/pharmacodynamics of faster aspart and IAsp.
METHODS


Free and total IAsp concentrations and anti-IAsp antibodies were determined in adults with type 1 diabetes mellitus receiving subcutaneous faster aspart and/or IAsp in four single-dose clinical pharmacology trials (n = 175) and a 26-week phase IIIa trial (n = 1040). Pharmacodynamics were assessed by euglycaemic clamp or meal test, respectively.
RESULTS


The pharmacokinetic profile was left-shifted and early exposure was greater with faster aspart versus IAsp independent of free or total IAsp assay. The faster aspart-IAsp difference in the time to 50% of maximum IAsp concentration in the early part of the pharmacokinetic profile (t Early 50 % Cmax ) [95% confidence interval (CI)] was - 8.8 [- 10.0 to - 7.5] and - 7.6 [- 8.8 to - 6.4] min for free and total IAsp, respectively. The faster aspart/IAsp ratio for the area under the concentration-time curve (AUC) for IAsp from time zero to 30 min (AUC IAsp,0-30 min ) [95% CI] was 1.88 [1.74-2.04] and 1.77 [1.64-1.90] for free and total IAsp. Higher anti-IAsp antibody levels were associated with a lower ratio of free/total IAsp for the total AUC for IAsp (AUC IAsp,0-t ). Early glucose-lowering effect (AUC for the glucose infusion rate [GIR] from time zero to 60 min [AUC GIR,0-60 min ]) was greater by 25-44% for faster aspart versus IAsp independent of anti-IAsp antibody levels. Total glucose-lowering effect (total AUC for GIR [AUC GIR,0-t ]) in a clamp and 1-h postprandial glucose increment in a meal test appeared essentially unaffected by anti-IAsp antibodies.
CONCLUSIONS


Faster aspart provides accelerated pharmacokinetics versus IAsp regardless if based on free or total IAsp assay. Higher anti-IAsp antibodies increase total IAsp concentrations but do not influence faster aspart nor IAsp pharmacodynamics. CLINICALTRIALS.
GOV IDENTIFIERS


NCT01618188, NCT02003677, NCT01934712, NCT02568280, NCT01831765.",2019,"Higher anti-IAsp antibody levels were associated with a lower ratio of free/total IAsp for the total AUC for IAsp (AUC IAsp,0-t ).","['adults with type 1 diabetes mellitus receiving subcutaneous faster aspart and/or IAsp in four single-dose clinical pharmacology trials (n\xa0=\xa0175) and a 26-week phase IIIa trial ', 'Subjects with Type 1 Diabetes Mellitus']","['Fast-Acting Insulin Aspart Versus Insulin Aspart', 'Fast-acting insulin aspart (faster aspart']","['faster aspart/IAsp ratio for the area under the concentration-time curve (AUC', 'Total glucose-lowering effect (total AUC for GIR [AUC GIR,0-t ', 'total IAsp concentrations and anti-IAsp antibodies', 'Early glucose-lowering effect (AUC for the glucose infusion rate [GIR', 'total IAsp concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031332', 'cui_str': 'Clinical pharmacology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",,0.0223411,"Higher anti-IAsp antibody levels were associated with a lower ratio of free/total IAsp for the total AUC for IAsp (AUC IAsp,0-t ).","[{'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Haahr', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. hhaa@novonordisk.com.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University Hospital Leuven, KU Leuven, UZ Herestraat 49, Box 902, 3000, Leuven, Belgium.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Gondolf', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'SOUSEIKAI, Hakata Clinic, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Erichsen', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Hellersbergstrasse 9, 41460, Neuss, Germany.'}]",Clinical pharmacokinetics,['10.1007/s40262-018-0718-6']
2345,30467742,"Pharmacokinetic and Pharmacodynamic Modeling to Optimize the Dose of Vestronidase Alfa, an Enzyme Replacement Therapy for Treatment of Patients with Mucopolysaccharidosis Type VII: Results from Three Trials.","INTRODUCTION


Mucopolysaccharidosis type VII (MPS VII, Sly Syndrome) is a progressive, debilitating, ultra-rare lysosomal storage disorder caused by the deficiency of β-glucuronidase (GUS), an enzyme required for breakdown of glycosaminoglycans (GAGs). Vestronidase alfa, a recombinant human GUS, is an enzyme replacement therapy approved in the US and EU for the treatment of MPS VII.
METHODS


The pharmacokinetics (PK) and pharmacodynamics (PD) of vestronidase alfa were evaluated in 23 adult and pediatric subjects with MPS VII enrolled in phase I-III clinical trials to optimize the clinical dosing regimen of vestronidase alfa. The serum concentration-time profiles were adequately described by a two-compartment population PK model incorporating subjects' body weight as the only significant covariate.
RESULTS


Model-based simulations predicted a substantially decreased time duration of serum exposures exceeding the level of K uptake  (the in vitro determined vestronidase alfa concentration corresponding to 50% maximum rate of cellular uptake) for 4 or 8 mg/kg once every 4 weeks dosing, compared with 4 mg/kg once every other week (QOW) dosing by intravenous infusion, suggesting that given the same total monthly dose, the QOW dosing frequency should result in more efficient delivery to the GUS-deficient tissue cells, and therefore superior treatment efficacy. A standard inhibitory maximal effect model reasonably explained the observed pharmacological PD responses of reduction in urinary GAGs from pretreatment baseline, which appeared to have reached the plateau of maximal effect at the 4 mg/kg QOW dose.
CONCLUSION


The modeling results, together with the clinical evidence of safety and efficacy, supported the recommended 4 mg/kg QOW dosing regimen of vestronidase alfa for pediatric and adult patients with MPS VII.
CLINICAL TRIAL REGISTRATION


NCT01856218, NCT02418455, NCT02230566.",2019,"The serum concentration-time profiles were adequately described by a two-compartment population PK model incorporating subjects' body weight as the only significant covariate.
","['23 adult and pediatric subjects with MPS VII enrolled in phase I-III clinical trials', 'pediatric and adult patients with MPS VII', 'Patients with Mucopolysaccharidosis Type VII']","['recombinant human GUS', 'Enzyme Replacement Therapy', 'vestronidase alfa']","['pharmacokinetics (PK) and pharmacodynamics (PD', 'time duration of serum exposures', 'serum concentration-time profiles', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085132', 'cui_str': 'Deficiency of beta-glucuronidase'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0017776', 'cui_str': 'Beta-glucuronidase'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C4519728', 'cui_str': 'Vestronidase alfa'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",23.0,0.0220004,"The serum concentration-time profiles were adequately described by a two-compartment population PK model incorporating subjects' body weight as the only significant covariate.
","[{'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA. yulan.qi@gmail.com.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McKeever', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haller', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Jones', 'Affiliation': ""Willink Unit, Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester and Academic Health Sciences Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., 60 Leveroni Court, Novato, CA, 94949, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-018-0721-y']
2346,32621599,Decontamination of Gutta-percha Cones employed in Endodontics.,"The gutta-percha cones used in endodontic treatment are produced in aseptic conditions and their composition includes zinc oxide, which is responsible for antibacterial activity. However, there is the possibility of microbial contamination by manipulation, aerosol or during storage. Although several chemical agents have been tested for their decontamination, there is no consensus on the best disinfection protocol to be used. The aim of this study was to evaluate the decontamination of gutta-percha cones contaminated with the bacteria Enterococcus faecalis, by using chlorhexidine digluconate (CHX) and sodium hypochlorite (NaClO) at different concentrations for short exposure times. For this purpose, gutta-percha cones (size 40) were selected at random from a sealed box and immersed for 1 min in a microbial suspension. Then they were immersed in specific Petri dishes for different groups containing: CHX 2%, NaClO 1% or NaClO 2.5% for 30 s or 1 min, and subsequently placed in tubes containing BHI broth. After incubating the tubes for 48 h, it was observed that 1% and 2.5% NaClO and 2% CHX were effective for decontaminating the cones at those exposure time intervals. Microbial growth was detected in one of the replicates of the group with CHX applied for 30 s. To prevent the possibility of failures at this stage, the exposure time of gutta-percha cones to the decontaminating agent should not be reduced.",2020,"Microbial growth was detected in one of the replicates of the group with CHX applied for 30 s. To prevent the possibility of failures at this stage, the exposure time of gutta-percha cones to the decontaminating agent should not be reduced.",['gutta-percha cones (size 40'],"['CHX', 'chlorhexidine digluconate (CHX) and sodium hypochlorite (NaClO']",['Microbial growth'],"[{'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0240606,"Microbial growth was detected in one of the replicates of the group with CHX applied for 30 s. To prevent the possibility of failures at this stage, the exposure time of gutta-percha cones to the decontaminating agent should not be reduced.","[{'ForeName': 'Clairde S', 'Initials': 'CS', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Estadual do Piauí, Coordenação Odontologia, Parnaíba, Piauí, Brasil.'}, {'ForeName': 'Moara Sc', 'Initials': 'MS', 'LastName': 'Pinto', 'Affiliation': 'Universidade Estadual do Piauí, Coordenação Odontologia, Parnaíba, Piauí, Brasil.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Batista', 'Affiliation': 'Universidade Estadual do Piauí, Coordenação Odontologia, Parnaíba, Piauí, Brasil.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Quelemes', 'Affiliation': 'Universidade Federal do Piauí, Mestrado em Odontologia Teresina, Piauí, Brasil.'}, {'ForeName': 'Carlos Am', 'Initials': 'CA', 'LastName': 'Falcão', 'Affiliation': 'Universidade Estadual do Piauí, Coordenação Odontologia, Parnaíba, Piauí, Brasil.'}, {'ForeName': 'Maria Aal', 'Initials': 'MA', 'LastName': 'Ferraz', 'Affiliation': 'Universidade Estadual do Piauí, Coordenação Odontologia, Parnaíba, Piauí, Brasil. angela.endo@hotmail.com.'}]",Acta odontologica latinoamericana : AOL,[]
2347,31336290,Perceptions of effectiveness and believability of pictorial and text-only health warning labels for cannabis products among Canadian youth.,"BACKGROUND


Health warnings have been shown to increase knowledge and awareness of health risks, influence social norms, and reduce consumption of tobacco products. With the legalization of non-medical cannabis in Canada and other subnational jurisdictions, there is a need for empirical studies to examine the impact of cannabis health warnings on consumer perceptions and behaviour relevant to cannabis.
METHODS


In October 2017, a between-group experiment was conducted as part of an online survey of Canadians aged 16 to 30 years (N = 870) recruited from a national consumer panel. Participants rated the perceived effectiveness and believability of either text-only or pictorial cannabis health warnings and then completed a message recall task. Participants also reported their level of support for cannabis warnings, and support for including cessation information and a quitline on the warnings.
RESULTS


Pictorial health warnings for cannabis products were perceived as more effective and believable than text-only warnings (p < 0.001), and the superiority of pictorial warnings was found across different warnings: dose (p = 0.039), co-morbid drug use (p = 0.006), and pregnancy (p < 0.001). Pictorial warnings were also rated as more believable (p = 0.048). Overall, 87.7% respondents supported having health warnings on cannabis products, and 84.0% supported the inclusion of a quitline number on cannabis health warnings.
CONCLUSION


The current study provides the first empirical test of cannabis health warnings, consistent with the considerable body of evidence on the effectiveness of pictorial warnings on tobacco products. There was strong support for the inclusion of picture warnings and the inclusion of resources and quitlines on cannabis packaging.",2019,"RESULTS


Pictorial health warnings for cannabis products were perceived as more effective and believable than text-only warnings (p < 0.001), and the superiority of pictorial warnings was found across different warnings: dose (p = 0.039), co-morbid drug use (p = 0.006), and pregnancy (p < 0.001).","['cannabis products among Canadian youth', 'Canadians aged 16 to 30 years (N\u202f=\u202f870) recruited from a national consumer panel']",['pictorial and text-only health warning labels'],"['effectiveness and believability of either text-only or pictorial cannabis health warnings', 'superiority of pictorial warnings']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",870.0,0.0538521,"RESULTS


Pictorial health warnings for cannabis products were perceived as more effective and believable than text-only warnings (p < 0.001), and the superiority of pictorial warnings was found across different warnings: dose (p = 0.039), co-morbid drug use (p = 0.006), and pregnancy (p < 0.001).","[{'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leos-Toro', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Canada.'}, {'ForeName': 'Geoffrey T', 'Initials': 'GT', 'LastName': 'Fong', 'Affiliation': 'Department of Psychology, University of Waterloo, Canada; Ontario Institute for Cancer Research, Canada.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'Meyer', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Canada. Electronic address: dhammond@uwaterloo.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2019.07.001']
2348,32647051,Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover.,"OBJECTIVE


To study the effect of 12 weeks of high-intensity interval training (HIIT) on glycemic control in adults with type 1 diabetes and overweight or obesity.
RESEARCH DESIGN AND METHODS


Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5% were randomized to 12 weeks of either HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control. In a partial crossover design, the control group subsequently performed the 12-week HIIT intervention. The primary end point was the change in HbA 1c  from baseline to 12 weeks. Glycemic and cardiometabolic outcomes were measured at 0, 12, and 24 weeks.
RESULTS


Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 . HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08). In participants who undertook at least 50% of the prescribed HIIT intervention, the HbA 1c  reduction was significantly greater than control (HIIT -0.64 ± 0.64% [ n  = 9], control -0.14 ± 0.48% [ n  = 15],  P  = 0.04). There were no differences in insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition between groups.
CONCLUSIONS


Overall, there was no significant reduction in HbA 1c  with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for people who undertake HIIT with greater adherence.",2020,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","['Adults With Type 1 Diabetes and Overweight or Obesity', 'adults with type 1 diabetes', 'Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5', 'adults with type 1 diabetes and overweight or obesity', 'Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 ']","['HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['change in HbA 1c', 'Glycemic and cardiometabolic outcomes', 'HbA 1c  reduction', 'insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition', 'HbA 1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517683', 'cui_str': '3.1'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",30.0,0.0504138,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Callum J', 'Initials': 'CJ', 'LastName': 'Baker', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martinez-Huenchullan', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jencia', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Flack', 'Affiliation': 'Diabetes Centre, Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia stephen.twigg@sydney.edu.au.'}]",Diabetes care,['10.2337/dc20-0342']
2349,32647053,Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial.,,2020,,['Type 2 Diabetes Patients With and'],['Liraglutide'],['Cardiovascular Outcomes'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0347564,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC matthew.crowley@duke.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Thomas Jon', 'Initials': 'TJ', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Diabetes care,['10.2337/dc20-0437']
2350,32647054,Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes.,"OBJECTIVE


Short-acting glucagon-like peptide 1 receptor agonists (GLP-1 RAs) decelerate gastric emptying more than long-acting GLP-1 RAs. Delayed gastric emptying is a risk factor for gastroesophageal reflux disease. We aimed to measure esophageal reflux and function as well as gastric emptying and acid secretion during treatment with short-acting (lixisenatide) and long-acting (liraglutide) GLP-1 RAs.
RESEARCH DESIGN AND METHODS


A total of 57 subjects with type 2 diabetes were randomized to a 10-week treatment with lixisenatide or liraglutide. Changes from baseline in the number of reflux episodes during 24-h pH registration in the lower esophagus, lower esophagus sphincter pressure, gastric emptying ( 13 C-sodium octanoate acid breath test), and gastric acid secretion ( 13 C-calcium carbonate breath test) were analyzed.
RESULTS


Gastric emptying half time was delayed by 52 min (Δ [95% CI] 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025). There was no difference in the number of reflux episodes (mean ± SEM 33.7 ± 4.1 vs. 40.1 ± 5.3 for lixisdenatide and liraglutide, respectively,  P  = 0.17) or the extent of gastroesophageal reflux (DeMeester score) (35.1 ± 6.7 vs. 39.7 ± 7.5,  P  = 0.61), with similar results for the individual GLP-1 RAs. No significant changes from baseline in other parameters of esophageal motility and lower esophageal sphincter function were observed. Gastric acidity decreased significantly by -20.7% (-40.6, -0.8) ( P  = 0.042) with the GLP-1 RAs.
CONCLUSIONS


Lixisenatide exerted a more pronounced influence on gastric emptying after breakfast than liraglutide. Neither lixisenatide nor liraglutide had significant effects on esophageal reflux or motility. Gastric acid secretion appears to be slightly reduced by GLP-1 RAs.",2020,"RESULTS


Gastric emptying half time was delayed by 52 min (Δ [95% CI] 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025).","['57 subjects with type 2 diabetes', 'Patients With Type 2 Diabetes']","['Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists', 'short-acting (lixisenatide) and long-acting (liraglutide) GLP-1 RAs', 'lixisenatide or liraglutide', 'liraglutide']","['Gastric acidity', 'Delayed gastric emptying', 'gastroesophageal reflux', 'number of reflux episodes', 'Gastric emptying half time', 'Gastric acid secretion', 'esophagus sphincter pressure, gastric emptying ( 13 C-sodium octanoate acid breath test), and gastric acid secretion', 'esophageal reflux or motility', 'gastric emptying and acid secretion', 'Esophageal and Gastric Function', 'esophageal motility and lower esophageal sphincter function', 'gastric emptying']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0017120', 'cui_str': 'Gastric acidity'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0142816', 'cui_str': 'Sodium caprylate'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0232538', 'cui_str': 'Gastric function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",57.0,0.0332538,"RESULTS


Gastric emptying half time was delayed by 52 min (Δ [95% CI] 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025).","[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Quast', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schenker', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Björn A', 'Initials': 'BA', 'LastName': 'Menge', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany juris.meier@ruhr-uni-bochum.de.'}]",Diabetes care,['10.2337/dc20-0720']
2351,32647083,Infusing the axioms of clinical reasoning while designing clinical anatomy case vignettes teaching for novice medical students: a randomised cross over study.,"The clinical reasoning skills is often gained when the biomedical knowledge is broadened and deepened alongside exposure to patients. The 'ideal' blend of axioms of clinical reasoning and case based learning would establish the pedagogical bridges right from the first year of medical education. So this study aimed to investigate the perceived importance and efficacy of teaching clinical reasoning skills among first year medical students, as this has not previously been described. As a priori, two clinical reasoning skill sessions were conducted using clinico-anatomical case vignettes designed according to the literature regarding clinical reasoning ('serial cue' approach and hypothetico-deduction). Students were divided into intervention and control group and crossed over in subsequent sessions. Analysis was done by mixed method approach including measuring proof of benefit using post-test comparison, quantitative survey and qualitative analysis by nominal group discussion. Post test scores were compared using student's  t -test. Feedbacks were analysed using descriptive statistics. The results showed that post test scores were significantly higher in intervention group than the control group in both sessions ( P <0.001, 0.016). A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students. clinico-anatomical case vignettes helped in understanding anatomical basis of clinical conditions for 61% students. To conclude, introducing clinical reasoning has considerable effect in improving the decision making ability of the students and if incorporated right from the first year, would better prepare the students in successful transition to clinical learning environment.",2020,"A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students.","['first year medical students', 'novice medical students']",[],"['diagnostic skills and lateral thinking abilities', 'problem-solving abilities']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233631', 'cui_str': 'Lateral thinking'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",,0.0186841,"A total of 66% students felt, diagnostic skills and lateral thinking abilities were improved and It helped in developing problem-solving abilities for 67% students.","[{'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'V', 'Affiliation': 'Department of Anatomy, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Rajprasath', 'Initials': 'R', 'LastName': 'R', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Priyadharshini', 'Affiliation': 'Department of Anatomy, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India.'}, {'ForeName': 'Magi', 'Initials': 'M', 'LastName': 'Murugan', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Devi', 'Affiliation': 'Department of Anatomy, Pondicherry Institute of Medical Sciences, Puducherry, India.'}]",Anatomy & cell biology,['10.5115/acb.19.199']
2352,32647106,A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation.,"BACKGROUND This was a prospective comparative study of mixed reality (MR) technology assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement. MATERIAL AND METHODS Fifty cases of lumbar pedicle screws placement were randomly divided into 2 groups: 25 cases with MR technology in group A, and 25 cases without MR technology in group B. All patients had their scores on the Oswestry disability index (ODI) of low back pain and the visual analog scale (VAS) of the affected lower limb recorded at pre-operation. Blood loss, operative duration, success rate of first penetration by tap, and number of times C-arm fluoroscopy was performed were recorded at intraoperation. The postoperative drainage was recorded. The ODI of low back pain and VAS of the affected lower limb were recorded at 1, 3, and 6 months after operation. RESULTS Group A had less bleeding, shorter operation time, higher success rate of first penetration by tap, and fewer times using C-arm fluoroscopy at intraoperation (P<0.05). There was significant difference in ODI scores and VAS scores at 1 mouth after operation (P<0.05). The postoperative drainage of group A was less than group B (P<0.05). The implantation accuracy of group A was higher than group B (P<0.05). The postoperative recovery rate of low back pain of group A was faster than group B (P<0.05). CONCLUSIONS The safety of spinal surgery and implantation accuracy of pedicle screw fixation system could be increased by MR technology.",2020,The postoperative recovery rate of low back pain of group A was faster than group B (P<0.05).,['Fifty cases of lumbar pedicle screws placement were randomly divided into 2 groups: 25 cases with'],"['pedicle screw fixation system', 'Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation', 'mixed reality (MR) technology assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement', 'MR technology in group A, and 25 cases without MR technology in group B']","['ODI of low back pain and VAS of the affected lower limb', 'ODI scores and VAS scores', 'implantation accuracy', 'Oswestry disability index (ODI) of low back pain and the visual analog scale (VAS', 'postoperative recovery rate of low back pain', 'bleeding, shorter operation time', 'Blood loss, operative duration, success rate of first penetration by tap, and number of times C-arm fluoroscopy', 'postoperative drainage']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",50.0,0.0239128,The postoperative recovery rate of low back pain of group A was faster than group B (P<0.05).,"[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The Third Clinical Medical College, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Qingqiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopedic, Nanjing First Hospital, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedic, Nanjing First Hospital, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Huikang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Digital Medicine Institute, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'The Third Clinical Medical College, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic, Nanjing First Hospital, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924982']
2353,32647277,Effectiveness of antimuscarinics and a beta-3 adrenoceptor agonist in patients with overactive bladder in a real-world setting.,"Both antimuscarinics and beta-3 adrenoceptor agonists are generally used as first-line pharmacotherapy for overactive bladder (OAB). This study aimed to investigate the differences in clinical characteristics and manifestations between different medication groups using real-world data. In this retrospective study, we recruited all patients aged > 18 years diagnosed with OAB at our institute from March 2010 to December 2017. They were allocated into three groups, the antimuscarinics (group A), beta-3 adrenoceptor agonist (group B), and discontinued (group C) treatment groups, and they completed OAB symptom score and quality of life questionnaires before and after treatment. In addition, the Clinical Global Impression was recorded for treatment outcomes. A premedication urodynamic study was also applied. A total of 215 patients were analyzed (group A: 43, B: 35, C: 137). Group B was significantly older (mean age 77.4 years) than group A (69.2 years, p = 0.012) and group C (68.6 years, p = 0.001). However, there were no significant differences in sex or underlying diseases among the groups. Before treatment, there were no significant differences in the questionnaire results among all groups. The cystometric capacity of group A (mean ± SD, 257.3 ± 135.1 cm 3 ) was significantly larger than that of group B (125.8 ± 46.0 cm 3 , p = 0.002) and group C (170.5 ± 99.2 cm 3 , p = 0.001). After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study. However, there were no significant differences in effectiveness between the patients who took antimuscarinics and those who took a beta-3 adrenoceptor agonist.",2020,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","['patients with overactive bladder in a real-world setting', 'patients aged >\u200918\xa0years diagnosed with OAB at our institute from March 2010 to December 2017', '215 patients were analyzed (group A: 43, B: 35, C: 137']","['antimuscarinics and a beta-3 adrenoceptor agonist', 'beta-3 adrenoceptor agonist']","['cystometric capacity', 'Clinical Global Impression', 'cystometric bladder capacity', 'OAB symptom score and quality of life questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C3252518', 'cui_str': 'ADRB3 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0429807', 'cui_str': 'Bladder capacity'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",215.0,0.0182709,"After treatment, there were no significant differences between group A and group B in any of the questionnaire scores; however, their scores were better than those of group C. The OAB patients who adhered to antimuscarinics tended to be younger and have larger cystometric bladder capacity in the urodynamic study.","[{'ForeName': 'Chiung-Kun', 'Initials': 'CK', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC. jayslylin@gmail.com.'}, {'ForeName': 'Alex Tong-Long', 'Initials': 'AT', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei, 11217, Taiwan, ROC.'}]",Scientific reports,['10.1038/s41598-020-68170-4']
2354,32647328,Changes in cardiorespiratory fitness and activity levels over the first year after discharge in ambulatory persons with recent incomplete spinal cord injury.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


To investigate changes in cardiorespiratory fitness (CRF) and activity level in ambulatory persons with SCI during the first year after discharge from inpatient rehabilitation.
SETTING


Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.
METHODS


Thirty persons with incomplete SCI, all community walkers (25 males and 5 females, 18-69 years old) were recruited to a clinical trial of a 12 weeks home-based aerobic exercise program of either high or moderate intensity. During the last week of inpatient rehabilitation (baseline), participants performed a maximal exercise test on a treadmill (peak oxygen uptake; peak VO 2 ) and a 6-min walking test (6MWT). Also, total daily energy expenditure (TDEE) and daily amount of steps were measured continuously during 7 days in the participants' homes. All tests were repeated after 3 and 12 months (post tests).
RESULTS


Twenty of the 30 clinical trial participants performed baseline and both posttests and are included in this secondary analysis. We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes. Therefore, data from both exercise groups and the control group were merged for secondary analyses, revealing statistically significant increase over time in peak VO 2 , 6MWT, and TDEE. The increase over time in the average daily steps did not reach statistical significance.
CONCLUSIONS


Ambulatory persons with SCI were able to increase their CRF levels over the first year after discharge from inpatient rehabilitation, despite a minimal increase in activity levels.",2020,"We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes.","['Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway', 'ambulatory persons with recent incomplete spinal cord injury', 'Ambulatory persons with SCI', 'Thirty persons with incomplete SCI, all community walkers (25 males and 5 females, 18-69 years old', 'ambulatory persons with SCI during the first year after discharge from inpatient rehabilitation']","['aerobic exercise program of either high or moderate intensity', 'maximal exercise test on a treadmill (peak oxygen uptake; peak VO 2 ) and a 6-min walking test (6MWT']","['cardiorespiratory fitness (CRF) and activity level', 'cardiorespiratory fitness and activity levels', 'total daily energy expenditure (TDEE) and daily amount of steps', 'time in peak VO 2 , 6MWT, and TDEE', 'time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes', 'activity levels', 'CRF levels']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.028803,"We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes.","[{'ForeName': 'Matthijs F', 'Initials': 'MF', 'LastName': 'Wouda', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway. Matthijs.wouda@sunnaas.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Lundgaard', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Vegard', 'Initials': 'V', 'LastName': 'Strøm', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}]",Spinal cord,['10.1038/s41393-020-0514-7']
2355,32647367,The efficacy of flaxseed and hesperidin on non-alcoholic fatty liver disease: an open-labeled randomized controlled trial.,"BACKGROUND/OBJECTIVES


Non-alcoholic fatty liver disease (NAFLD) is growing in prevalence globally and no definitive evidence for any approved pharmacological approaches for patients with NAFLD has been found yet. This study was aimed to assess the clinical effects of flaxseed and hesperidin in patients with NAFLD.
SUBJECTS/METHODS


In this randomized, controlled, clinical trial, one hundred eligible patients with NAFLD were enrolled and randomly assigned to four dietary intervention groups including lifestyle modification program (control), lifestyle modification program with 30 g whole flaxseed powder, lifestyle modification program with 1 g hesperidin supplementation, and lifestyle modification program with combination of 30 g flaxseed and 1 g hesperidin (flax-hes) for 12 weeks. The changes in anthropometric parameters, metabolic profiles of glucose and lipids, inflammatory biomarkers and hepatic steatosis and fibrosis were evaluated.
RESULTS


After the 12-week dietary interventions, significant reductions in body mass index, glucose hemostasis parameters and hepatic steatosis were observed in all groups. Repeated measures analysis of variance revealed a significant effect for time relative to almost all paraclinical parameters. Post hoc analysis with Bonferroni correction revealed that the three intervention groups experienced significant decreases in plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index compared to control (p < 0.008).
CONCLUSIONS


In conclusion, our study confirmed that hesperidin and flaxseed supplementation improved glucose and lipid metabolism, while reduced inflammation and hepatic steatosis (controlled attenuation parameter) in NAFLD patients. The synergistic effects of their combination were observed on plasma glucose concentration and HOMA-IR.",2020,"Post hoc analysis with Bonferroni correction revealed that the three intervention groups experienced significant decreases in plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index compared to control (p < 0.008).
","['patients with NAFLD', 'non-alcoholic fatty liver disease', 'NAFLD patients', 'one hundred eligible patients with NAFLD']","['flaxseed and hesperidin', 'dietary intervention groups including lifestyle modification program (control), lifestyle modification program with 30\u2009g whole flaxseed powder, lifestyle modification program with 1\u2009g hesperidin supplementation, and lifestyle modification program with combination of 30\u2009g flaxseed and 1', 'hesperidin and flaxseed supplementation']","['glucose and lipid metabolism', 'plasma glucose concentration and HOMA-IR', 'plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index', 'body mass index, glucose hemostasis parameters and hepatic steatosis', 'anthropometric parameters, metabolic profiles of glucose and lipids, inflammatory biomarkers and hepatic steatosis and fibrosis', 'inflammation and hepatic steatosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0019392', 'cui_str': 'Hesperidin'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",100.0,0.0597086,"Post hoc analysis with Bonferroni correction revealed that the three intervention groups experienced significant decreases in plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index compared to control (p < 0.008).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Makan', 'Initials': 'M', 'LastName': 'Cheraghpour', 'Affiliation': 'Cancer Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Bio_makan@yahoo.com.'}, {'ForeName': 'Seyed Moayed', 'Initials': 'SM', 'LastName': 'Alavian', 'Affiliation': 'Middle East Liver Diseases (MELD) Center, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Eini-Zinab', 'Affiliation': 'Department of Community Nutrition, National Nutrition and Food Technology Research Institute; and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. a_hekmat2000@yahoo.com.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0679-3']
2356,32647425,Magnesium Therapy Improves Rotational Thromboelastometry Findings Prior to Liver Transplantation: A Randomized Clinical Trial.,"An important challenge during orthotopic liver transplantation (OLT) is optimal coagulation management. There are diverse studies regarding effect of Mg sulfate on coagulation system. This study evaluates the impact of Mg sulfate on the coagulation parameters of the rotational thromboelastometry (ROTEM) in patients about to undergo OLT. In this randomized clinical trial, 60 patients who were going to undergo OLT were randomly allocated into two groups. In the Mg group, the patients received a 1.5 g infusion of Mg 5 min before the surgical incision. In the control group, patients received a physiological saline instead of Mg. Plasma Mg levels before and after the infusions were measured in both groups. Also, three ROTEM tests: EXTEM, INTEM and FIBTEM were performed before and after the infusions. Baseline mean plasma magnesium levels were within normal range in the control and Mg groups: 2.06 and 2.18 mg/dl, respectively. After magnesium therapy, the mean plasma Mg level in the Mg group increased to 2.78 mg/dl in compared to the control group that was 2.01 mg/dl ( P  < 0.000). Mean value of the clotting time (CT) in the magnesium group were significantly decreased from 129.50 ± 7.76, 381.86 ± 8.51 and 114.26 ± 6.80 to 86.13 ± 3.4, 209.33 ± 6.68 and 81.56 ± 5.01 in the EXTEM, INTEM, and FIBTEM respectively after intervention in the Mg group ( P  = 0.001). Among patients with end-stage liver diseases who have ROTEM evidence of hypocoagulability, magnesium could correct CT parameter of the ROTEM tests.",2020,"Baseline mean plasma magnesium levels were within normal range in the control and Mg groups: 2.06 and 2.18 mg/dl, respectively.","['patients with end-stage liver diseases', 'patients about to undergo OLT', '60 patients who were going to undergo OLT', 'Liver Transplantation']","['orthotopic liver transplantation (OLT', 'Mg sulfate', 'physiological saline instead of Mg', 'Magnesium Therapy']","['Baseline mean plasma magnesium levels', 'Mean value of the clotting time (CT', 'Plasma Mg levels', 'mean plasma Mg level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745744', 'cui_str': 'End stage liver disease'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0729823', 'cui_str': 'Plasma magnesium measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0368930', 'cui_str': 'Coagulation time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0316207,"Baseline mean plasma magnesium levels were within normal range in the control and Mg groups: 2.06 and 2.18 mg/dl, respectively.","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sahmeddini', 'Affiliation': 'Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Taghizadehimani', 'Affiliation': 'Department of Anesthesiology and Critical Care, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Khosravi', 'Affiliation': 'Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Eghbal', 'Affiliation': 'Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion,['10.1007/s12288-020-01260-5']
2357,32647469,Comparative evaluation of Platelet Rich Plasma (PRP) versus Platelet Rich Fibrin (PRF) scaffolds in regenerative endodontic treatment of immature necrotic permanent maxillary central incisors: A double blinded randomized controlled trial.,"Objectives


The research aims to assess the regenerative potential of Platelet Rich Plasma (PRP) versus Platelet Rich Fibrin (PRF) scaffolds in immature permanent maxillary central incisors with necrotic pulps, clinically and radiographically.
Trial design


Double blinded parallel randomized controlled trial was implemented to identify the results.
Subject & methods


The proposed study was conducted among 30 patients with maxillary necrotic permanent immature central incisors but only 26 patients fulfilled the study requirements. Group I was treated with PRP and Group II with PRF scaffolds. Follow up has been done every 3 months for one year. Primary outcomes were measured clinically: Pain, Mobility, Swelling, and Sinus/fistula. Radiographically: increase root length and width. Secondary outcomes were clinically: Discoloration and Sensibility test. Radiographically: increase in bone density measurements and decrease in apical diameter. Standardized radiographs were collected during the follow up period, and radiographic changes were measured by using Image J software. Statistical analysis was performed on 25 patients who had completed the study.
Results


All 25 patients' teeth were survived during the 12-month follow-up period .  PRP showed marginal increase in radiographic root length and width, periapical bone density and a decrease in apical diameter. No statistical significant differences were observed when it was compared with PRF. The teeth which were treated did not respond to sensibility test at the end of the study. PRF displayed statistical significant higher amount of crown discoloration when compared to PRP group .
Conclusions


For necrotic immature teeth, revascularization using PRP is an appropriate alternative to PRF and showed excellent 12-months prognosis.",2020,"For necrotic immature teeth, revascularization using PRP is an appropriate alternative to PRF and showed excellent 12-months prognosis.","['25 patients who had completed the study', 'immature permanent maxillary central incisors with necrotic pulps, clinically and radiographically', 'immature necrotic permanent maxillary central incisors', '30 patients with maxillary necrotic permanent immature central incisors but only 26 patients fulfilled the study requirements']","['PRP', 'Platelet Rich Plasma (PRP) versus Platelet Rich Fibrin (PRF) scaffolds']","['apical diameter', 'crown discoloration', 'radiographic root length and width, periapical bone density and a decrease in apical diameter', 'clinically: Pain, Mobility, Swelling, and Sinus/fistula', 'bone density measurements', 'clinically: Discoloration and Sensibility test', 'root length and width']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",30.0,0.13942,"For necrotic immature teeth, revascularization using PRP is an appropriate alternative to PRF and showed excellent 12-months prognosis.","[{'ForeName': 'Hazim Mohamed', 'Initials': 'HM', 'LastName': 'Rizk', 'Affiliation': 'Pediatric Dentistry, Preventive & Dental Public Health Department, Faculty of Dentistry, Suez Canal University, Egypt.'}, {'ForeName': 'Mohamed Sherif Mohamed', 'Initials': 'MSM', 'LastName': 'Salah Al-Deen', 'Affiliation': 'Pediatric Dentistry, Preventive & Dental Public Health Department, Faculty of Dentistry, Suez Canal University, Egypt.'}, {'ForeName': 'Asmaa Aly', 'Initials': 'AA', 'LastName': 'Emam', 'Affiliation': 'Pediatric Dentistry, Preventive & Dental Public Health Department, Faculty of Dentistry, Suez Canal University, Egypt.'}]",The Saudi dental journal,['10.1016/j.sdentj.2019.09.002']
2358,32647498,"Individualized Whole-Body Vibration: Neuromuscular, Biochemical, Muscle Damage and Inflammatory Acute Responses.","Objective . We aimed to investigate the acute residual hormonal, biochemical, and neuromuscular responses to a single session of individualized whole-body vibration (WBV) while maintaining a half-squat position.  Methods.  Twenty male sport science students voluntarily participated in the present study and were randomly assigned to an individualized WBV group (with the acceleration load determined for each participant) or an isometric group (ISOM). A double-blind, controlled parallel study design with repeated measures was employed.  Results.  Testosterone and growth hormone increased significantly over time in the WBV group ( P  < .05 and  P  < .01, respectively; effect size [ES] ranged from 1.00 to 1.23), whereas cortisol increased over time in both groups ( P  < .01; ES ranged from 1.04 and 1.36). Interleukin-6 and creatine kinase increased significantly over time only in the WBV group ( P  < .05; ES = 1.07). The maximal voluntary contraction decreased significantly over time in the ISOM group ( P  = .019; ES = 0.42), whereas in the WBV group, the decrease did not reach a significant level ( P  = .05). The ratio of electromyographic activity and power decreased significantly over time in the WBV group ( P  < .01; ES ranged from 0.57 to 0.72).  Conclusion.  Individualized WBV increased serum hormonal concentrations, muscle damage, and inflammation to levels similar to those induced by resistance training and hypertrophy exercises.",2020,Interleukin-6 and creatine kinase increased significantly over time only in the WBV group ( P  < .05; ES = 1.07).,['Twenty male sport science students voluntarily participated in the present study'],"['Individualized Whole-Body Vibration', 'individualized WBV group (with the acceleration load determined for each participant) or an isometric group (ISOM']","['ratio of electromyographic activity and power', 'Testosterone and growth hormone', 'cortisol', 'maximal voluntary contraction', 'serum hormonal concentrations, muscle damage, and inflammation to levels', 'Neuromuscular, Biochemical, Muscle Damage and Inflammatory Acute Responses', 'Interleukin-6 and creatine kinase']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",20.0,0.0342392,Interleukin-6 and creatine kinase increased significantly over time only in the WBV group ( P  < .05; ES = 1.07).,"[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Di Giminiani', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rucci', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Capuano', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ponzetti', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Aielli', 'Affiliation': 'Oncological Unit, G Mazzini Hospital, Teramo, Italy.'}, {'ForeName': 'Jozsef', 'Initials': 'J', 'LastName': 'Tihanyi', 'Affiliation': 'Department of Biomechanics, University of Physical Education, Budapest, Hungary.'}]",Dose-response : a publication of International Hormesis Society,['10.1177/1559325820931262']
2359,32647513,Comparison of the effects between low- versus medium-energy radial extracorporeal shock wave therapy on knee osteoarthritis: A randomised controlled trial.,"Objective


This study aimed to compare the effects between low- versus medium-energy radial extracorporeal shock wave therapy on knee osteoarthritis (KOA).
Method


Forty-five patients (26 women and 19 men) aged 45-55 years with grade 2 KOA were randomly assigned into the following three groups (all n = 15): Group A received low-energy radial shock wave therapy (2000 shock/session [10 Hz], energy flux density [EFD] 0.02 mJ/mm 2 ) with strengthening exercises once per week for 4 weeks; Group B received medium-energy radial shock wave therapy (2000 shock/session [10 Hz], EFD 0.178 mJ/mm 2 ) with strengthening exercises once per week for 4 weeks; and Group C (control group) received sham shock wave therapy with strengthening exercises once per week for 4 weeks. Severity of pain was determined using the visual analogue scale, and knee physical function was assessed using the Arabic version of the knee injury and osteoarthritis outcome score physical function short form. Knee proprioception was measured before and after the treatment programme using an isokinetic dynamometer.
Results


The within-group analysis showed significant differences in severity of pain, knee physical function, and knee proprioception in Groups A and B before and after the treatment programme (p < 0.05). The between-group analysis showed significant differences in all variables after treatment, with more significant differences observed in Group B than in Groups A and C (p < 0.05).
Conclusion


Low- and medium-energy radial shock wave therapies are effective modalities for the treatment of KOA, with medium-energy radial shock wave therapy being superior to low-energy radial shock wave therapy.",2020,"The within-group analysis showed significant differences in severity of pain, knee physical function, and knee proprioception in Groups A and B before and after the treatment programme (p < 0.05).","['knee osteoarthritis', 'Method\n\n\nForty-five patients (26 women and 19 men) aged 45-55 years with grade 2 KOA', 'knee osteoarthritis (KOA']","['medium-energy radial shock wave therapy (2000 shock/session [10\xa0Hz], EFD 0.178\xa0mJ/mm 2 ) with strengthening exercises once per week for 4 weeks; and Group C (control group) received sham shock wave therapy with strengthening exercises', 'low-energy radial shock wave therapy (2000 shock/session [10\xa0Hz], energy flux density [EFD] 0.02\xa0mJ/mm 2 ) with strengthening exercises', 'low- versus medium-energy radial extracorporeal shock wave therapy']","['severity of pain, knee physical function, and knee proprioception', 'Severity of pain', 'visual analogue scale, and knee physical function', 'Knee proprioception']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4517398', 'cui_str': '0.02'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0612404,"The within-group analysis showed significant differences in severity of pain, knee physical function, and knee proprioception in Groups A and B before and after the treatment programme (p < 0.05).","[{'ForeName': 'Radwa F', 'Initials': 'RF', 'LastName': 'Hammam', 'Affiliation': 'Basic Science Department, Faculty of physical therapy, Modern University for Technology and Information, Egypt.'}, {'ForeName': 'Ragia M', 'Initials': 'RM', 'LastName': 'Kamel', 'Affiliation': 'Basic Science Department, Faculty of physical therapy, Cairo University, Egypt.'}, {'ForeName': 'Amira H', 'Initials': 'AH', 'LastName': 'Draz', 'Affiliation': 'Basic Science Department, Faculty of physical therapy, Cairo University, Egypt.'}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Azzam', 'Affiliation': 'Institute of Neuromotor System, Egypt.'}, {'ForeName': 'Shimaa T', 'Initials': 'ST', 'LastName': 'Abu El Kasem', 'Affiliation': 'Basic Science Department, Faculty of physical therapy, Cairo University, Egypt.'}]",Journal of Taibah University Medical Sciences,['10.1016/j.jtumed.2020.04.003']
2360,32647517,The effect of proton pump inhibitors on glycaemic control in diabetic patients.,"Objective


This study aimed to evaluate the effect of proton pump inhibitors on glycaemic control amongst diabetic patients taking anti-diabetic medications.
Methods


This randomised interventional clinical study was conducted in Basic Medical Sciences Institute, Jinnah Postgraduate Medical Centre, Karachi. Eighty patients of either sex (aged 30-60 years) with type 2 diabetes mellitus and without any known comorbidities were equally divided into two groups (i.e.,  n  = 40 for each group) and were included in this study. Group A received metformin and glimepiride, while Group B, metformin and glimepiride plus omeprazole. The efficacy of the combination medications was evaluated based on fasting blood sugar (FBS) and glycosylated haemoglobin (HbA1c) levels. Serum creatinine and liver function tests were reviewed to evaluate patients' safety profile at the initial visit and after 12 weeks.
Results


After 12 weeks of omeprazole therapy, we observed a more significant improvement in glycaemic control in group B compared to group A based on the patients' FBS (108 ± 2.37 vs. 126 ± 2.9, P = 0.001) and HbA1c levels (7.29 ± 0.07 vs. 7.47 ± 0.04, P = 0.030).
Conclusion


The addition of a proton pump inhibitor along with anti-diabetic medications was considered effective in achieving better glycaemic control.",2020,"After 12 weeks of omeprazole therapy, we observed a more significant improvement in glycaemic control in group B compared to group A based on the patients' FBS (108 ± ","['diabetic patients taking anti-diabetic medications', 'Eighty patients of either sex (aged 30-60 years) with type 2 diabetes mellitus and without any known comorbidities', 'diabetic patients']","['omeprazole', 'proton pump inhibitors', 'metformin and glimepiride plus omeprazole', 'metformin and glimepiride', 'proton pump inhibitor']","['Serum creatinine and liver function tests', 'glycaemic control', 'fasting blood sugar (FBS) and glycosylated haemoglobin (HbA1c) levels', 'HbA1c levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0404524,"After 12 weeks of omeprazole therapy, we observed a more significant improvement in glycaemic control in group B compared to group A based on the patients' FBS (108 ± ","[{'ForeName': 'Muhammad Ali', 'Initials': 'MA', 'LastName': 'Rajput', 'Affiliation': 'Department of Pharmacology, Multan Medical and Dental College, Multan, Pakistan.'}, {'ForeName': 'Fizzah', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Department of Pharmacology, Liaquat National Medical College, Karachi, Pakistan.'}, {'ForeName': 'Tabassum', 'Initials': 'T', 'LastName': 'Zehra', 'Affiliation': 'Department of Pharmacology, Liaquat National Medical College, Karachi, Pakistan.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Pathology, Liaquat College of Medicine & Dentistry, Karachi, Pakistan.'}, {'ForeName': 'Gunesh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacology, Liaquat University of Medical & Health Sciences, Jamshoro, Pakistan.'}]",Journal of Taibah University Medical Sciences,['10.1016/j.jtumed.2020.03.003']
2361,32647531,The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial.,"Background


Lower post-prandial glucose (PPG) and insulin (PPI) responses to foods are associated with reduced diabetes risk and progression. Several plant extracts have been proposed to reduce PPG or PPI by inhibiting enzymes or transporters involved in carbohydrate digestion and uptake. This study evaluates a range of such extracts, consumed with a carbohydrate load, for their effects on PPG, PPI and indicators of (gastrointestinal) tolerance.
Methods


Interventions were extracts of mulberry fruit (MFE, 1.5 g), mulberry leaf (MLE, 1.0 g), white bean (WBE, 3.0 g), apple (AE, 2.0 g), elderberry (EE, 2.0 g), turmeric (TE, 0.18 g), AE + TE, and EE + TE. Each of these 8 individual extracts or combinations were added to a rice porridge containing ~ 50 g available carbohydrate (control). In a within-subject (randomised, balanced incomplete block) design, individual subjects received the control and a subset of 4 of the 8 extracts or combinations. Participants were 72 apparently healthy adults (mean [SD] age 31.2 [5.5] yr, body mass index 22.1 [2.0] kg/m 2 ). The primary outcome was the percentage change in 2-h PPG (positive incremental area under the curve) relative to control. Secondary measures were the 2-h PPI response, 7-h breath hydrogen, measures of gastrointestinal discomfort, and urine glucose.
Results


In the 65 subjects who completed the control and at least one intervention treatment, additions of AE, MFE and MLE produced statistically significant reductions in PPG vs control ( p  < 0.05; mean effect - 24.1 to - 38.1%). All extracts and combinations except TE and WBE significantly reduced PPI ( p  < 0.01; mean effect - 17.3% to - 30.4%). Rises in breath hydrogen > 10 ppm were infrequent, but statistically more frequent than control only for MLE ( p  = 0.02). Scores for gastrointestinal discomfort were extremely low and not different from control for any treatment, and no glucosuria was observed.
Conclusions


Additions of AE, MFE and MLE to rice robustly reduced PPG and PPI. EE significantly reduced only PPI, while TE and WBE showed no significant efficacy for PPG or PPI. Breath hydrogen responses to MLE suggest possible carbohydrate malabsorption at the dose used, but there were no explicit indications of intolerance to any of the extracts.
Trial registration


ClinicalTrials.gov identifier NCT04258501. Registered 6 February 2020 - Retrospectively registered.",2020,All extracts and combinations except TE and WBE significantly reduced PPI ( p  < 0.01; mean effect - 17.3% to - 30.4%).,"['Registered 6 February 2020 - Retrospectively registered', 'healthy adults', 'Participants were 72 apparently healthy adults (mean [SD] age 31.2 [5.5] yr, body mass index 22.1']","['8 plant extracts and combinations', '\n\n\nLower post-prandial glucose (PPG) and insulin (PPI', 'rice porridge containing ~\u200950']","['Rises in breath hydrogen', 'percentage change in 2-h PPG (positive incremental area under the curve) relative to control', 'Scores for gastrointestinal discomfort', 'PPG', 'PPG, PPI and indicators of (gastrointestinal) tolerance', '2-h PPI response, 7-h breath hydrogen, measures of gastrointestinal discomfort, and urine glucose', 'PPI']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191319', 'cui_str': '31.2'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452575', 'cui_str': 'Porridge'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004076', 'cui_str': 'Glucose measurement, urine'}]",72.0,0.0717394,All extracts and combinations except TE and WBE significantly reduced PPI ( p  < 0.01; mean effect - 17.3% to - 30.4%).,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mela', 'Affiliation': 'Unilever R&D, Wageningen, the Netherlands.'}, {'ForeName': 'Xiu-Zhen', 'Initials': 'XZ', 'LastName': 'Cao', 'Affiliation': 'Unilever R&D Shanghai, Shanghai, China.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Dobriyal', 'Affiliation': 'Hindustan Unilever Research Centre, Mumbai, India.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'Fowler', 'Affiliation': 'Unilever R&D, Sharnbrook, UK.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Unilever R&D Shanghai, Shanghai, China.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Unilever R&D, Bangalore, IN India.'}, {'ForeName': 'Theo J P', 'Initials': 'TJP', 'LastName': 'Mulder', 'Affiliation': 'Unilever R&D, Wageningen, the Netherlands.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Murray', 'Affiliation': 'Unilever R&D, Sharnbrook, UK.'}, {'ForeName': 'Harry P F', 'Initials': 'HPF', 'LastName': 'Peters', 'Affiliation': 'Unilever R&D, Wageningen, the Netherlands.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Vermeer', 'Affiliation': 'Unilever R&D, Wageningen, the Netherlands.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Unilever R&D Shanghai, Shanghai, China.'}]",Nutrition & metabolism,['10.1186/s12986-020-00471-x']
2362,32647560,OXY-SCORE: a new perspective for left ventricular hypertrophy diagnosis.,"Background


A recently developed global indicator of oxidative stress (OXY-SCORE), by combining individual plasma biomarkers of oxidative damage and antioxidant capacity, has been validated in several pathologies, but not in left ventricular hypertrophy (LVH). The aim of this study was to design and calculate a plasma oxidative stress global index for patients with LVH.
Methods


A total of 70 consecutive adult patients were recruited in our institution and assigned to one of the two study groups (control group/LVH group) by an echocardiography study. We evaluated plasmatic biomarkers of oxidative damage (malondialdehyde and thiolated proteins) and antioxidant defense (total thiols, reduced glutathione, total antioxidant capacity, catalase, and superoxide dismutase activities) by spectrophotometry/fluorimetry in order to calculate a plasma oxidative stress global index (OXY-SCORE) in relation to LVH.
Results


The OXY-SCORE exhibited a highly significant difference between the groups ( p  < 0.001). The area under the receiver operating characteristic curve was 0.74 (95% confidence interval (CI), 0.62-0.85;  p  < 0.001). At a cut-off value of -1, the 68.6% sensitivity and 68.6% specificity values suggest that OXY-SCORE could be used to screen for LVH. A multivariable logistic regression model showed a positive association ( p  = 0.001) between OXY-SCORE and LVH [odds ratio = 0.55 (95% CI, 0.39-0.79)], independent of gender, age, smoking, glucose, systolic and diastolic arterial pressure, dyslipidemia, estimated glomerular filtration rate, body mass index, and valvular/coronary disease.
Conclusion


OXY-SCORE could help in the diagnosis of LVH and could be used to monitor treatment response.",2020,"We evaluated plasmatic biomarkers of oxidative damage (malondialdehyde and thiolated proteins) and antioxidant defense (total thiols, reduced glutathione, total antioxidant capacity, catalase, and superoxide dismutase activities) by spectrophotometry/fluorimetry in order to calculate a plasma oxidative stress global index (OXY-SCORE) in relation to LVH.
","['patients with LVH', '70 consecutive adult patients']",[],"['plasmatic biomarkers of oxidative damage (malondialdehyde and thiolated proteins) and antioxidant defense (total thiols, reduced glutathione, total antioxidant capacity, catalase, and superoxide dismutase activities', 'gender, age, smoking, glucose, systolic and diastolic arterial pressure, dyslipidemia, estimated glomerular filtration rate, body mass index, and valvular/coronary disease', 'plasma oxidative stress global index', 'plasma oxidative stress global index (OXY-SCORE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0918173,"We evaluated plasmatic biomarkers of oxidative damage (malondialdehyde and thiolated proteins) and antioxidant defense (total thiols, reduced glutathione, total antioxidant capacity, catalase, and superoxide dismutase activities) by spectrophotometry/fluorimetry in order to calculate a plasma oxidative stress global index (OXY-SCORE) in relation to LVH.
","[{'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Quintana-Villamandos', 'Affiliation': 'Department of Anesthesiology Hospital Gregorio Marañón. C/, Doctor Esquerdo Nº 46, Madrid, 28007, Spain Department of Pharmacology and Toxicology, Faculty of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Pazó-Sayós', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'González Del Pozo', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universidad Autónoma, Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Bellón', 'Affiliation': 'Department Statistics, Health Research Institute of Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Pedraz-Prieto', 'Affiliation': 'Department of Cardiovascular Surgery, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Ángel G', 'Initials': 'ÁG', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiovascular Surgery, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'González', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universidad Autónoma, Madrid, Spain.'}]",Therapeutic advances in chronic disease,['10.1177/2040622320936417']
2363,32647573,The Freiburg sport therapy program for eating disorders: a randomized controlled trial.,"Background


Unhealthy attitudes towards sport and problematic exercise behavior in eating disorders (ED) are common and associated with poorer treatment outcome and higher relapse rates. There is a need to develop and empirically test interventions that could complement standard treatment. The study aimed to assess the efficacy of the Freiburg sport therapy program for eating disorders (FSTP).
Methods


Outpatients with ED were randomized either to a 3 month sport therapy program (sport therapy group: STG) or a waiting list control group (CG). Patients were assessed when starting the program and at the end of the intervention. The intervention group (STG) was followed up after 6 month. Main outcome criterion was a reduction in unhealthy exercise (Commitment to Exercise Scale, CES). Secondary outcomes encompassed eating pathology (Eating Disorder Examination, EDE), different dimensions of unhealthy exercise (Compulsive Exercise Test, CET subscales) and exercise quantity (accelerometer).
Results


Recruitment was challenging. Fifteen patients were randomized to the STG and 11 were randomized to the CG condition. There was no statistically significant difference between groups according to the main outcome criterion. However, the STG showed a significantly stronger reduction in avoidance and rule driven behavior (CET subscale) when compared to the CG. Improvements (STG) were maintained at follow up.
Conclusions


There was no statistically significant difference in the reduction of unhealthy attitudes towards sport and problematic exercise behavior between the intervention and the group, as measured with the Commitment to Exercise Scale. Further findings may point to the effectiveness of the program, but have to be interpreted with caution and verified in further studies. A major limitation is the small sample size.
Trial registration


Study register: ISRCTN 14776348 (registered 26 January, 2015.",2020,"There was no statistically significant difference in the reduction of unhealthy attitudes towards sport and problematic exercise behavior between the intervention and the group, as measured with the Commitment to Exercise Scale.","['Fifteen patients', 'eating disorders (FSTP', 'Methods\n\n\nOutpatients with ED', 'eating disorders']","['sport therapy program (sport therapy group: STG) or a waiting list control group (CG', 'Freiburg sport therapy program']","['avoidance and rule driven behavior (CET subscale', 'reduction in unhealthy exercise (Commitment to Exercise Scale, CES', 'reduction of unhealthy attitudes towards sport and problematic exercise behavior', 'eating pathology (Eating Disorder Examination, EDE), different dimensions of unhealthy exercise (Compulsive Exercise Test, CET subscales) and exercise quantity (accelerometer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",15.0,0.0470812,"There was no statistically significant difference in the reduction of unhealthy attitudes towards sport and problematic exercise behavior between the intervention and the group, as measured with the Commitment to Exercise Scale.","[{'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Zeeck', 'Affiliation': 'Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg, Hauptstraße 8, D-79104 Freiburg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schlegel', 'Affiliation': 'Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg, Hauptstraße 8, D-79104 Freiburg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Jagau', 'Affiliation': 'Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg, Hauptstraße 8, D-79104 Freiburg, Germany.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Lahmann', 'Affiliation': 'Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg, Hauptstraße 8, D-79104 Freiburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg, Hauptstraße 8, D-79104 Freiburg, Germany.'}]",Journal of eating disorders,['10.1186/s40337-020-00309-0']
2364,32647644,Improvement of the symptoms of lower urinary tract and sexual dysfunction with tadalafil and solifenacin after the treatment of benign prostatic hyperplasia with dutasteride.,"Background


The aim of this research is to study the influence of simultaneous taking of tadalafil and solifenacin in standard and double dosage on the lower urinary tract symptoms (LUTS) and sexual dysfunction in men with benign prostatic hyperplasia after the course of dutasteride.
Materials and methods


The research included 326 patients older than 50 years with benign prostatic hyperplasia coupled with LUTS and sexual dysfunction having undergone the course of treatment with dutasteride. After random division into three groups, patients from the Group A ( n  = 107) got tadalafil 5 mg/d as monotherapy, from the Group В ( n  = 107) got tadalafil 5 mg/d and solifenacin 10 mg/d, and from the Group С ( n  = 112) got tadalafil 5 mg/d and solifenacin 20 mg/d. The duration of treatment was 12 weeks. The rating of sexual function was made with the questionnaires International Index of Erectile Function and other.
Results


The results of rating of sexual function with the questionnaires MSHQ-EjD and International Index of Erectile Function correlated among themselves. According to MSHQ-EjD, overall rating of the sexual function increased in each of the three groups (A: 67.9 (12.4)/91.5 (10.4),  P  ≤ 0.05; B: 72.4 (14.5)/102.6 (16.9),  P  ≤ 0.05; C: 76.6 (16.3)/109.6 (15.6),  P  ≤ 0.05). The level of hyperactivity symptoms decreased in Groups В and С (В: urgency -2.9 (0.7)/1.1 (0.6),  P  ≤ 0.05; nocturia 2.7 (1.0)/0.7 (0.5),  P  ≤ 0.05; C: urgency -2.5 (0.5)/0.8 (0.6),  P  ≤ 0.05; nocturia -2.8 (0.6)/1.0 (0.5),  P  ≤ 0.05), and it did not change in the Group A.
Conclusions


The use of tadalafil as monotherapy significantly improves the sexual function but does not affect overactive bladder symptoms. The combination therapy of tadalafil and solifenacin leads to dramatic improvement of sexual function and reversibility of detrusor hyperactivity symptoms.",2020,"According to MSHQ-EjD, overall rating of the sexual function increased in each of the three groups (A: 67.9 (12.4)/91.5 (10.4),  P  ≤ 0.05; B: 72.4 (14.5)/102.6 (16.9),  P  ≤ 0.05; C: 76.6 (16.3)/109.6 (15.6),  P  ≤ 0.05).","['326 patients older than 50\xa0years with benign prostatic hyperplasia coupled with LUTS\xa0and sexual dysfunction having undergone the course of treatment with', 'men with benign prostatic hyperplasia after the course of dutasteride', 'benign prostatic hyperplasia with']","['tadalafil and solifenacin', 'solifenacin', 'dutasteride', 'tadalafil', 'tadalafil 5\xa0mg']","['level of hyperactivity symptoms', 'sexual function', 'MSHQ-EjD, overall rating of the sexual function', 'rating of sexual function with the questionnaires MSHQ-EjD and International Index of Erectile Function', 'overactive bladder symptoms', 'sexual function and reversibility of detrusor hyperactivity symptoms', 'rating of sexual function']","[{'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}]",326.0,0.0209173,"According to MSHQ-EjD, overall rating of the sexual function increased in each of the three groups (A: 67.9 (12.4)/91.5 (10.4),  P  ≤ 0.05; B: 72.4 (14.5)/102.6 (16.9),  P  ≤ 0.05; C: 76.6 (16.3)/109.6 (15.6),  P  ≤ 0.05).","[{'ForeName': 'Kirill V', 'Initials': 'KV', 'LastName': 'Kosilov', 'Affiliation': 'Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Primorsky Region, Russian Federation.'}, {'ForeName': 'Irina G', 'Initials': 'IG', 'LastName': 'Kuzina', 'Affiliation': 'Department of Social Science, Far Eastern Federal University, Vladivostok, Primorsky Region, Russian Federation.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kuznetsov', 'Affiliation': 'Department of Public Health, Pacific State Medical University, Vladivostok, Primorsky Region, Russian Federation.'}, {'ForeName': 'Ekaterina K', 'Initials': 'EK', 'LastName': 'Kosilova', 'Affiliation': 'Pacific State Medical University, Vladivostok, Primorsky Region, Russian Federation.'}]",Prostate international,['10.1016/j.prnil.2019.11.005']
2365,32647667,Dual-mode ultrasound radiomics and intrinsic imaging phenotypes for diagnosis of lymph node lesions.,"Background


The ultrasonic diagnosis of lymph node lesions is usually based on a small number of subjective visual features from a single ultrasonic modality, which limits diagnostic accuracy. Therefore, our study aimed to propose a computerized method for using dual-mode ultrasound radiomics and the intrinsic imaging phenotypes for accurately differentiating benign, lymphomatous, and metastatic lymph nodes.
Methods


A total of 543 lymph nodes from 538 patients were examined with both B-mode ultrasonography and elastography. The data set was randomly divided into a training set of 407 nodes and a validation set of 136 nodes. First, we extracted 430 radiomic features from dual-mode images. Then, we combined the least absolute shrinkage and selection operator with the analysis of variance to select several typical features. We retrieved the intrinsic imaging phenotypes by using a hierarchical clustering of all radiomics features, and we integrated the phenotypes with the selected features for the classification of benign, lymphomatous, and metastatic nodes.
Results


The areas under the receiver operating characteristic curves (AUCs) on the validation set were 0.960 for benign  vs.  lymphomatous, 0.716 for benign  vs.  metastatic, 0.933 for lymphomatous  vs.  metastatic, and 0.856 for benign  vs.  malignant.
Conclusions


The radiomics features and intrinsic imaging phenotypes derived from the dual-mode ultrasound can capture the distinctions between benign, lymphomatous, and metastatic nodes and are valuable in node differentiation.",2020,"The areas under the receiver operating characteristic curves (AUCs) on the validation set were 0.960 for benign  vs.  lymphomatous, 0.716 for benign  vs.  metastatic, 0.933 for lymphomatous  vs.  metastatic, and 0.856 for benign  vs.  malignant.
",['A total of 543 lymph nodes from 538 patients were examined with both B-mode ultrasonography and elastography'],[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}]",[],[],538.0,0.0208167,"The areas under the receiver operating characteristic curves (AUCs) on the validation set were 0.960 for benign  vs.  lymphomatous, 0.716 for benign  vs.  metastatic, 0.933 for lymphomatous  vs.  metastatic, and 0.856 for benign  vs.  malignant.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, Shanghai University, Shanghai, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, Shanghai University, Shanghai, China.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Ultrasound Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, Shanghai University, Shanghai, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasound Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, Shanghai University, Shanghai, China.'}]",Annals of translational medicine,['10.21037/atm-19-4630']
2366,32647709,Hypoxia-related parameters during septic shock resuscitation: Pathophysiological determinants and potential clinical implications.,"Background


Assessment of tissue hypoxia at the bedside has yet to be translated into daily clinical practice in septic shock patients. Perfusion markers are surrogates of deeper physiological phenomena. Lactate-to-pyruvate ratio (LPR) and the ratio between veno-arterial PCO 2  difference and Ca-vO 2  (ΔPCO 2 /Ca-vO 2 ) have been proposed as markers of tissue hypoxia, but they have not been compared in the clinical scenario. We studied acute septic shock patients under resuscitation. We wanted to evaluate the relationship of these hypoxia markers with clinical and biochemical markers of hypoperfusion during septic shock resuscitation.
Methods


Secondary analysis of a randomized controlled trial. Septic shock patients were randomized to fluid resuscitation directed to normalization of capillary refill time (CRT) versus normalization or significant lowering of lactate. Multimodal assessment of perfusion was performed at 0, 2, 6 and 24 hours, and included macrohemodynamic and metabolic perfusion variables, CRT, regional flow and hypoxia markers. Patients who attained their pre-specified endpoint at 2-hours were compared to those who did not.
Results


Forty-two patients were recruited, median APACHE-II score was 23 [15-31] and 28-day mortality 23%. LPR and ΔPCO 2 /Ca-vO 2  ratio did not correlate during early resuscitation (0-2 h) and the whole study period (24-hours). ΔPCO 2 /Ca-vO 2  ratio derangements were more prevalent than LPR ones, either in the whole cohort (52%  vs.  23%), and in association with other perfusion abnormalities. In patients who reached their resuscitation endpoints, the proportion of patients with altered ΔPCO 2 /Ca-vO 2  ratio decreased significantly (66% to 33%, P=0.045), while LPR did not (14%  vs.  25%, P=0.34).
Conclusions


Hypoxia markers did not exhibit correlation during resuscitation in septic shock patients. They probably interrogate different pathophysiological processes and mechanisms of dysoxia during early septic shock. Future studies should better elucidate the interaction and clinical role of hypoxia markers during septic shock resuscitation.",2020,LPR and ΔPCO 2 /Ca-vO 2  ratio did not correlate during early resuscitation (0-2 h) and the whole study period (24-hours).,"['Septic shock patients', 'septic shock patients', 'Forty-two patients were recruited, median APACHE-II score was 23 [15-31] and 28-day mortality 23', 'acute septic shock patients under resuscitation']",[],"['altered ΔPCO 2 /Ca-vO 2  ratio', 'LPR and ΔPCO 2 /Ca-vO 2  ratio', 'macrohemodynamic and metabolic perfusion variables, CRT, regional flow and hypoxia markers', 'Lactate-to-pyruvate ratio (LPR', 'ΔPCO 2 /Ca-vO 2  ratio derangements']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",42.0,0.136057,LPR and ΔPCO 2 /Ca-vO 2  ratio did not correlate during early resuscitation (0-2 h) and the whole study period (24-hours).,"[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Pavez', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Kattan', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Vera', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ferri', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Emilio Daniel', 'Initials': 'ED', 'LastName': 'Valenzuela', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Alegría', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bravo', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Pairumani', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Santis', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Oviedo', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Dagoberto', 'Initials': 'D', 'LastName': 'Soto', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Ospina-Tascón', 'Affiliation': 'Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICES, Cali, Colombia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Annals of translational medicine,['10.21037/atm-20-2048']
2367,32647793,Response and Survival Outcomes to Ibrutinib Monotherapy for Patients With Waldenström Macroglobulinemia on and off Clinical Trials.,"Ibrutinib is the first approved therapy for symptomatic patients with Waldenström macroglobulinemia (WM). The approval was based on a single, multicenter, phase II trial in previously treated WM patients. We sought to evaluate whether there were differences in clinical characteristics, response, and survival outcomes to ibrutinib monotherapy between WM patients treated on and off clinical trials. Treatment naïve and previously treated patients who received ibrutinib monotherapy at our institution and participated in two prospective studies (ON trial; n = 72) or a prospective database (OFF trial; n = 157) were included. The median times from WM diagnosis to ibrutinib initiation were 3.1 and 3.5 years for ON and OFF trial patients, respectively (p = 0.38). Similar rates of categorical response at 6, 12, and 24 months and at best response were also observed between ON trial and OFF trial patients. The 4-year PFS and OS rates for ON trial and OFF trial patients were 72% and 63%, respectively (log-rank p = 0.14) and 83% and 81%, respectively (log-rank p = 0.14). CXCR4 mutations impacted response and survival outcomes to ibrutinib monotherapy. The 4-year rates of ibrutinib discontinuation in ON and OFF trial patients were 36% and 44%, respectively (p = 0.11). Ibrutinib is effective in the routine clinical care of both treatment-naïve and previously treated WM patients. The findings of our study validate the efficacy of ibrutinib monotherapy reported in multiple phase II clinical trials.",2020,"The 4-year PFS and OS rates for ON trial and OFF trial patients were 72% and 63%, respectively (log-rank","['Patients With Waldenström Macroglobulinemia on and off Clinical Trials', 'symptomatic patients with Waldenström macroglobulinemia (WM', 'at our institution and participated in two prospective studies (ON trial; n\u200a=\u200a72) or a prospective database (OFF trial; n\u200a=\u200a157) were included']",['ibrutinib monotherapy'],"['categorical response', '4-year PFS and OS rates', '4-year rates of ibrutinib discontinuation', 'clinical characteristics, response, and survival outcomes', 'median times from WM diagnosis to ibrutinib initiation', 'Response and Survival Outcomes', 'response and survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024419', 'cui_str': ""Waldenstrom's macroglobulinemia""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024419', 'cui_str': ""Waldenstrom's macroglobulinemia""}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",157.0,0.0876206,"The 4-year PFS and OS rates for ON trial and OFF trial patients were 72% and 63%, respectively (log-rank","[{'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Castillo', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Gustine', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Meid', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Flynn', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Demos', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Guerrera', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Jimenez', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kofides', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Munshi', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Tsakmaklis', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Patterson', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Zachary R', 'Initials': 'ZR', 'LastName': 'Hunter', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Treon', 'Affiliation': ""Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA, USA.""}]",HemaSphere,['10.1097/HS9.0000000000000363']
2368,32647803,A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin Lymphoma After Nivolumab Monotherapy Failure.,"This single-center prospective clinical trial evaluated the combination of nivolumab plus bendamustine (NB) as a salvage regimen in classical Hodgkin lymphoma patients after failure of nivolumab monotherapy. A total of 30 patients received nivolumab (3 mg/kg) on D1,14 and bendamustine (90 mg/m 2 ) on D1, 2 of a 28-day cycle for up to 3 cycles. The ORR was 87% with 57% CR, 30% PR. With median follow-up of 25 months, the estimated 2-year OS was 96,7% (95% CI, 90.2%-100%), PFS was 23,3% (95% CI, 8.2%-38.4%) median PFS was 10.2 months (95% CI, 7.7-14.2 months) with median DOR 6.6 months (95% CI 3.9-11.6 months). Ten patients (33.3%) experienced grade 3 to 4 AE during therapy. Infections were most common AEs of the combined therapy. NB was a highly efficient salvage regimen in relapsed/refractory cHL with a manageable toxicity profile and modest potential for achievement of long-term remission. Registered at www.clinicaltrials.gov (#NCT0334365).",2020,NB was a highly efficient salvage regimen in relapsed/refractory cHL with a manageable toxicity profile and modest potential for achievement of long-term remission.,"['classical Hodgkin lymphoma patients after failure of nivolumab monotherapy', 'Patients With Relapsed/Refractory Hodgkin Lymphoma']","['nivolumab (3\u200amg/kg) on D1,14 and bendamustine', 'Nivolumab and Bendamustine (NB', 'nivolumab plus bendamustine (NB']","['median PFS', 'PFS', 'estimated 2-year OS', 'ORR']","[{'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855082', 'cui_str': ""Refractory Hodgkin's lymphoma""}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}]",30.0,0.0729228,NB was a highly efficient salvage regimen in relapsed/refractory cHL with a manageable toxicity profile and modest potential for achievement of long-term remission.,"[{'ForeName': 'Kirill V', 'Initials': 'KV', 'LastName': 'Lepik', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Natalia B', 'Initials': 'NB', 'LastName': 'Mikhailova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Kondakova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Yuri R', 'Initials': 'YR', 'LastName': 'Zalyalov', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Liudmila V', 'Initials': 'LV', 'LastName': 'Fedorova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Luibov A', 'Initials': 'LA', 'LastName': 'Tsvetkova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Polina V', 'Initials': 'PV', 'LastName': 'Kotselyabina', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Evgeniya S', 'Initials': 'ES', 'LastName': 'Borzenkova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Babenko', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Marina O', 'Initials': 'MO', 'LastName': 'Popova', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Darskaya', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Baykov', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Ivan S', 'Initials': 'IS', 'LastName': 'Moiseev', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Boris V', 'Initials': 'BV', 'LastName': 'Afanasyev', 'Affiliation': 'Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation.'}]",HemaSphere,['10.1097/HS9.0000000000000401']
2369,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
2370,32647935,Correction to: Efficacy of pulsed Nd:YAG laser in the treatment of patients with knee osteoarthritis: a randomized controlled trial.,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,2020,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,['patients with knee osteoarthritis'],['pulsed Nd:YAG laser'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}]",[],,0.0401531,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,"[{'ForeName': 'Mohamed Salaheldien Mohamed', 'Initials': 'MSM', 'LastName': 'Alayat', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia. mohsalahpt@hotmail.com.'}, {'ForeName': 'Tarek Helmy Ahmed', 'Initials': 'THA', 'LastName': 'Aly', 'Affiliation': 'Radiology Department, Um Al-Qura University Medical Center, Mecca, Saudi Arabia.'}, {'ForeName': 'Aly Elsayed Mohamed', 'Initials': 'AEM', 'LastName': 'Elsayed', 'Affiliation': 'Al-Noor Specialist Hospital, Mecca, Saudi Arabia.'}, {'ForeName': 'Ammar Suliman Mohamed', 'Initials': 'ASM', 'LastName': 'Fadil', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia.'}]",Lasers in medical science,['10.1007/s10103-020-03088-x']
2371,32647961,Three-dimensional prediction of nose morphology in Chinese young adults: a pilot study combining cone-beam computed tomography and 3dMD photogrammetry system.,"The nose is the most prominent part of the face and is a crucial factor for facial esthetics as well as facial reconstruction. Although some studies have explored the features of external nose and predicted the relationships between skeletal structures and soft tissues in the nasal region, the reliability and applicability of methods used in previous studies have not been reproduced. In addition, the majority of previous studies have focused on the sagittal direction, whereas the thickness of the soft tissues was rarely analyzed in three dimensions. A few studies have explained the specific characteristics of the nose of Chinese individuals. The aim of this study was to investigate the relationship between the hard nasal structures and soft external nose in three dimensions and to predict the morphology of the nose based on hard-tissue measurements. To eliminate the influence of low resolution of CBCT and increase the accuracy of measurement, three-dimensional (3D) images captured by cone-beam computed tomography (CBCT) and 3dMD photogrammetry system were used in this study. Twenty-six measurements (15 measurements for hard tissue and 11 measurements for soft tissue) based on 5 craniometric and 5 capulometric landmarks of the nose of 120 males and 120 females were obtained. All of the subjects were randomly divided into an experimental group (180 subjects consisting of 90 males and 90 females) and a test group (60 subjects consisting of 30 males and 30 females). Correlation coefficients between hard- and soft-tissue measurements were analyzed, and regression equations were obtained based on the experimental group and served as predictors to estimate nasal morphology in the test group. Most hard- and soft-tissue measurements appeared significantly different between genders. The strongest correlation was found between basis nasi protrusion and nasospinale protrusion (0.499) in males, and nasal height and nTr-nsTr (0.593) in females. For the regression equations, the highest value of R 2  was observed in the nasal bridge length in males (0.257) and nasal tip protrusion in females (0.389). The proportion of subjects with predicted errors < 10% was over 86.7% in males and 70.0% in females. Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation. Further research should investigate other influencing factors such as age, skeletal types, facial proportions, or population variance in nasal morphology estimation.",2020,Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation.,"['180 subjects consisting of 90 males and 90 females) and a test group (60 subjects consisting of 30 males and 30 females', 'Chinese young adults', '120 males and 120 females were obtained']",['cone-beam computed tomography and 3dMD photogrammetry system'],"['nasal bridge length', 'nasal tip protrusion']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0225408', 'cui_str': 'Structure of dorsum of nose'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}]",180.0,0.0203007,Our study proved that a combined CBCT and 3dMD photogrammetry system is a reliable method for nasal morphology estimation.,"[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chu', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Jia-Min', 'Initials': 'JM', 'LastName': 'Zhao', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Meng-Qi', 'Initials': 'MQ', 'LastName': 'Han', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Mou', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Ji', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ""College of Medicine and Forensics, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, Xi'an, 710004, Shaanxi, People's Republic of China.""}, {'ForeName': 'Shao-Yi', 'Initials': 'SY', 'LastName': 'Du', 'Affiliation': ""Institute of Artificial Intelligence and Robotics, College of Artificial Intelligence, Xi'an Jiaotong University, 28 Xianning West Road, Xi'an, 710049, Shaanxi, People's Republic of China. dushaoyi@xjtu.edu.cn.""}, {'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'Guo', 'Affiliation': ""Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, 98 XiWu Road, Xi'an, 710004, Shaanxi, People's Republic of China. xjtu-guoyucheng@163.com.""}]",International journal of legal medicine,['10.1007/s00414-020-02351-8']
2372,32640124,Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts.,"BACKGROUND


Baloxavir marboxil (baloxavir) is a polymerase acidic protein (PA) endonuclease inhibitor with clinical efficacy in the treatment of uncomplicated influenza, including in outpatients at increased risk for complications. The postexposure prophylactic efficacy of baloxavir in the household setting is unclear.
METHODS


We conducted a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the postexposure prophylactic efficacy of baloxavir in household contacts of index patients with confirmed influenza during the 2018-2019 season in Japan. The participants were assigned in a 1:1 ratio to receive either a single dose of baloxavir or placebo. The primary end point was clinical influenza, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 10 days. The occurrence of baloxavir-selected PA substitutions associated with reduced susceptibility was assessed.
RESULTS


A total of 752 household contacts of 545 index patients were randomly assigned to receive baloxavir or placebo. Among the index patients, 95.6% had influenza A virus infection, 73.6% were younger than 12 years of age, and 52.7% received baloxavir. Among the participants who could be evaluated (374 in the baloxavir group and 375 in the placebo group), the percentage in whom clinical influenza developed was significantly lower in the baloxavir group than in the placebo group (1.9% vs. 13.6%) (adjusted risk ratio, 0.14; 95% confidence interval [CI], 0.06 to 0.30; P<0.001). Baloxavir was effective in high-risk, pediatric, and unvaccinated subgroups of participants. The risk of influenza infection, regardless of symptoms, was lower with baloxavir than with placebo (adjusted risk ratio, 0.43; 95% CI, 0.32 to 0.58). The incidence of adverse events was similar in the two groups (22.2% in the baloxavir group and 20.5% in the placebo group). In the baloxavir group, the viral PA substitutions I38T/M or E23K were detected in 10 (2.7%) and 5 (1.3%) participants, respectively. No transmission of these variants from baloxavir-treated index patients to participants in the placebo group was detected; however, several instances of transmission to participants in the baloxavir group could not be ruled out.
CONCLUSIONS


Single-dose baloxavir showed significant postexposure prophylactic efficacy in preventing influenza in household contacts of patients with influenza. (Funded by Shionogi; Japan Primary Registries Network number, JapicCTI-184180.).",2020,"CONCLUSIONS


Single-dose baloxavir showed significant postexposure prophylactic efficacy in preventing influenza in household contacts of patients with influenza.","['A total of 752 household contacts of 545 index patients', 'household contacts of index patients with confirmed influenza during the 2018-2019 season in Japan', 'Household Contacts', 'household contacts of patients with influenza']","['Baloxavir', 'baloxavir', 'Baloxavir Marboxil', 'Baloxavir marboxil (baloxavir', 'baloxavir or placebo', 'placebo']","['postexposure prophylactic efficacy', 'clinical influenza, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing', 'clinical influenza', 'viral PA substitutions I38T/M or E23K', 'incidence of adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.380895,"CONCLUSIONS


Single-dose baloxavir showed significant postexposure prophylactic efficacy in preventing influenza in household contacts of patients with influenza.","[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ikematsu', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kinoshita', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Menno D', 'Initials': 'MD', 'LastName': 'de Jong', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takashima', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Noshi', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'From Ricerca Clinica, Fukuoka (H.I.), and Shionogi, Osaka (K.K., M.K., S.T., T.N., K.T., T.U.) - both in Japan; the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.); the Department of Medical Microbiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (M.D.J.); and the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada (N.L.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915341']
2373,32640130,Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for  SOD1  ALS.,"BACKGROUND


Tofersen is an antisense oligonucleotide that mediates the degradation of superoxide dismutase 1 (SOD1) messenger RNA to reduce SOD1 protein synthesis. Intrathecal administration of tofersen is being studied for the treatment of amyotrophic lateral sclerosis (ALS) due to  SOD1  mutations.
METHODS


We conducted a phase 1-2 ascending-dose trial evaluating tofersen in adults with ALS due to  SOD1  mutations. In each dose cohort (20, 40, 60, or 100 mg), participants were randomly assigned in a 3:1 ratio to receive five doses of tofersen or placebo, administered intrathecally for 12 weeks. The primary outcomes were safety and pharmacokinetics. The secondary outcome was the change from baseline in the cerebrospinal fluid (CSF) SOD1 concentration at day 85. Clinical function and vital capacity were measured.
RESULTS


A total of 50 participants underwent randomization and were included in the analyses; 48 participants received all five planned doses. Lumbar puncture-related adverse events were observed in most participants. Elevations in CSF white-cell count and protein were reported as adverse events in 4 and 5 participants, respectively, who received tofersen. Among participants who received tofersen, one died from pulmonary embolus on day 137, and one from respiratory failure on day 152; one participant in the placebo group died from respiratory failure on day 52. The difference at day 85 in the change from baseline in the CSF SOD1 concentration between the tofersen groups and the placebo group was 2 percentage points (95% confidence interval [CI], -18 to 27) for the 20-mg dose, -25 percentage points (95% CI, -40 to -5) for the 40-mg dose, -19 percentage points (95% CI, -35 to 2) for the 60-mg dose, and -33 percentage points (95% CI, -47 to -16) for the 100-mg dose.
CONCLUSIONS


In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks. CSF pleocytosis occurred in some participants receiving tofersen. Lumbar puncture-related adverse events were observed in most participants. (Funded by Biogen; ClinicalTrials.gov number, NCT02623699; EudraCT number, 2015-004098-33.).",2020,"In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks.","['50 participants underwent randomization and were included in the analyses; 48 participants', 'participants who received tofersen, one died from pulmonary embolus on day 137, and one from respiratory failure on day 152; one participant in the', 'adults with ALS due to  SOD1  mutations']","['tofersen or placebo', 'placebo']","['Clinical function and vital capacity', 'safety and pharmacokinetics', 'cerebrospinal fluid (CSF) SOD1 concentration', 'CSF pleocytosis', 'Lumbar puncture-related adverse events', 'CSF SOD1 concentrations', 'CSF SOD1 concentration']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0422813', 'cui_str': 'Clinical function'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151857', 'cui_str': 'Pleocytosis'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.595845,"In adults with ALS due to  SOD1  mutations, CSF SOD1 concentrations decreased at the highest concentration of tofersen administered intrathecally over a period of 12 weeks.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Andersen', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Bucelli', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Glass', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Ludolph', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Maragakis', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDermott', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pestronk', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ravits', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salachas', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Trudell', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Zinman', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'C Frank', 'Initials': 'CF', 'LastName': 'Bennett', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Sandrock', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Runz', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Houshyar', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McCampbell', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nestorov', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Ih', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Manjit', 'Initials': 'M', 'LastName': 'McNeill', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fanning', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fradette', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}, {'ForeName': 'Toby A', 'Initials': 'TA', 'LastName': 'Ferguson', 'Affiliation': 'From the Washington University School of Medicine, St. Louis (T.M., R.C.B., A.P.); the Healey Center for ALS, Massachusetts General Hospital, Harvard Medical School, Boston (M.C., N.A.), and Biogen, Cambridge (A.S., H.R., D.G., H.H., A.M., I.N., I.C., L.F., S.F., T.A.F.) - both in Massachusetts; the Sheffield Institute for Translational Neuroscience, University of Sheffield, and NIHR Sheffield Biomedical Research Centre and Clinical Research Facility, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (P.J.S., C.J.M.), and Biogen, Maidenhead (M.M.) - both in the United Kingdom; the Department of Clinical Science, Neurosciences, Umeå University, Umea, Sweden (P.M.A.); Montreal Neurological Institute and Hospital, Montreal (A.G.), and Sunnybrook Research Institute, Toronto (L.Z.); Emory University, Atlanta (J.G.); Barrow Neurological Institute, Phoenix, AZ (S.L.); the University of Ulm, Ulm, Germany (A.L.L.); Johns Hopkins University School of Medicine, Baltimore (N.J.M.); the University of California San Diego, La Jolla (J.R.), and Ionis Pharmaceuticals, Carlsbad (C.F.B., R.L.) - both in California; Paris ALS Centre, Hôpital de la Salpêtrière, Paris (F.S.); the University of Tennessee Medical Center, Knoxville (R.T.); and KU Leuven, VIB Center for Brain and Disease Research, University Hospitals Leuven, Leuven, Belgium (P.V.D.).'}]",The New England journal of medicine,['10.1056/NEJMoa2003715']
2374,32640318,Risk Factors for Spinal Cord Injury and Complications of Cerebrospinal Fluid Drainage in Patients Undergoing Fenestrated and Branched Endovascular Aneurysm Repair.,"OBJECTIVE


Spinal cord injury (SCI) is one of the most devastating complications of thoracoabdominal aortic aneurysm (TAAA) repair. Cerebrospinal fluid drainage (CSFD) is routinely used to prevent and treat SCI during open TAAA repair. However, the risks and benefits of CSFD during fenestrated-branched endovascular aneurysm repair (F-BEVAR) are unclear. This study aims to determine the risk of SCI after F-BEVAR and to assess the risks and benefits of CSFD.
METHODS


We analyzed 106 consecutive patients with TAAAs treated with F-BEVAR from 2014-2019 in a prospective physician-sponsored investigational device exemption study (G130193) registered with ClinicalTrials.gov (NCT02323581). Data were collected prospectively and audited by an independent external monitor. All patients were treated with Cook manufactured patient-specific F-BEVAR devices or the Cook t-Branch devices. CSFD was used at the discretion of the principal investigator. Risk factors for SCI were identified and CSFD complications were assessed.
RESULTS


Prophylactic CSFD was utilized in 78 patients (73.6%) and 28 patients (26.4%) underwent F-BEVAR without CSFD. Four patients (3.8%) with prophylactic CSFD developed SCI, including 2 patients (1.9%) with permanent paraplegia (Tarlov Grade 1-2) and 2 patients (1.9%) with paraparesis (Tarlov Grade 3). Multivariate analysis revealed that greater extent of thoracic aortic coverage (P=0.02, OR 1.06, 95%CI 1.00-1.11) and intraoperative blood loss (IBL) (P=0.04 , OR 1.00, 95%CI 1.00-1.002) were the significant risk factors for SCI. Six patients (7.6%; 6/78) experienced major CSFD-related complications including: subarachnoid hemorrhage in 2.6% (2), spinal hematoma in 2.6% (2), cerebellar hemorrhage in 1.3% (1) , and spinal drain fracture requiring surgical laminectomy in 1.3% (1). Minor CSFD-related complications occurred in 20 patients (25.6%; 20/78), including: paresthesia during CSFD insertion (10), minimal bloody CSF (7), drain malfunction (2), and reflex hypotension (1). Technical difficulties during CSFD catheter placement were noted in 7 patients (9.0%). Excluding 4 patients with SCI, ICU length of stay (LOS) was 3.3±4.0 days in CSFD group versus 1.2±0.9 days in No-CSFD group (P=0.007). Total hospital LOS was 6.0±4.9 days in CSFD group versus 3.5±1.9 days in No-CSFD group (P=0.01).
CONCLUSION


The incidence of SCI after F-BEVAR with selective CSFD was low and risk factors for SCI were greater extent of thoracic aortic coverage and IBL. However, the incidence of major CSFD-related complications exceeded the incidence of SCI and CSFD significantly increased both ICU and total hospital LOS. Therefore, routine prophylactic CSFD may not be justified and a prospective randomized trial of CSFD in patients undergoing F-BEVAR seems appropriate.",2020,"Total hospital LOS was 6.0±4.9 days in CSFD group versus 3.5±1.9 days in No-CSFD group (P=0.01).
","['Patients Undergoing Fenestrated and Branched Endovascular Aneurysm Repair', '106 consecutive patients with TAAAs treated with F-BEVAR from 2014-2019 in a prospective physician-sponsored investigational device exemption study (G130193) registered with ClinicalTrials.gov (NCT02323581']","['Cerebrospinal fluid drainage (CSFD', 'Prophylactic CSFD', 'Cook manufactured patient-specific F-BEVAR devices or the Cook t-Branch devices', 'CSFD']","['cerebellar hemorrhage', 'ICU length of stay (LOS', 'Technical difficulties during CSFD catheter placement', 'paresthesia during CSFD insertion (10), minimal bloody CSF (7), drain malfunction (2), and reflex hypotension (1', 'spinal drain fracture requiring surgical laminectomy', 'intraoperative blood loss (IBL', 'ICU and total hospital LOS', 'Total hospital LOS', 'thoracic aortic coverage', 'Minor CSFD-related complications', 'subarachnoid hemorrhage', 'spinal hematoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205384', 'cui_str': 'Branching'}]","[{'cui': 'C0149854', 'cui_str': 'Cerebellar hemorrhage'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",106.0,0.129753,"Total hospital LOS was 6.0±4.9 days in CSFD group versus 3.5±1.9 days in No-CSFD group (P=0.01).
","[{'ForeName': 'Napong', 'Initials': 'N', 'LastName': 'Kitpanit', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York; Department of Surgery, Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Sharif H', 'Initials': 'SH', 'LastName': 'Ellozy', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Connolly', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Agrusa', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Lichtman', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Schneider', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Weill Cornell Medicine, New York-Presbyterian Hospital, New York. Electronic address: dbs9003@med.cornell.edu.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.05.070']
2375,32640411,"The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.","BACKGROUND


Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change.
METHODS


A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA).
RESULTS


Analysis yielded three overarching themes: taking part in a treatment trial - ""the only thing out there"", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an ""unpredictable recovery"".
CONCLUSIONS


People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.",2020,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","['participants with dissociative seizures', 'adults with Dissociative non-Epileptic Seizures (CODES) Trial', '30 participants in an', 'people with dissociative seizures (DS']","['DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC', 'RCT (the COgnitive behavioral therapy vs standardized medical care']",[],"[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",[],30.0,0.0596229,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purnell', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107230']
2376,32640554,Psychological and Physiological Responses in Patients with Generalized Anxiety Disorder: The Use of Acute Exercise and Virtual Reality Environment.,"Virtual exercise therapy is considered a useful method by which to encourage patients with generalized anxiety disorder (GAD) to engage in aerobic exercise in order to reduce stress. This study was intended to explore the psychological and physiological responses of patients with GAD after cycling in a virtual environment containing natural images. Seventy-seven participants with GAD were recruited in the present study and randomly assigned to a virtual nature (VN) or a virtual abstract painting (VAP) group. Their electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction were assessed at baseline and after an acute bout of 20 min of moderate-intensity aerobic exercise. The results showed that both the VN and VAP groups showed significantly higher alpha activity post-exercise as compared to pre-exercise. The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction. These findings imply that a virtual exercise environment is an effective way to induce a relaxing effect in patients with GAD. However, they exhibited more positive psychological responses when exercising in such an environment with natural landscapes.",2020,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","['Seventy-seven participants with GAD', 'Patients with Generalized Anxiety Disorder', 'patients with GAD', 'patients with GAD after cycling in a virtual environment containing natural images', 'patients with generalized anxiety disorder (GAD']","['VAP', 'virtual nature (VN) or a virtual abstract painting (VAP', 'Acute Exercise and Virtual Reality Environment', 'Virtual exercise therapy', 'virtual exercise environment']","['alpha activity post-exercise', 'Psychological and Physiological Responses', 'positive psychological responses', 'stress-relief, restorative quality, and personal satisfaction', 'electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031206', 'cui_str': 'Personal wellbeing status'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",77.0,0.0381468,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","[{'ForeName': 'Tsai-Chiao', 'Initials': 'TC', 'LastName': 'Wang', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Cindy Hui-Ping', 'Initials': 'CH', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ta-Wei', 'Initials': 'TW', 'LastName': 'Tang', 'Affiliation': 'Department of Leisure and Recreation Management, Asia University, Taichung 413, Taiwan.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17134855']
2377,32640602,"Efficacy of a Six-Week Dispersed Wingate-Cycle Training Protocol on Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life in Healthy Adults.","BACKGROUND


The aim of this study was to evaluate the efficacy of a six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol on peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life, in healthy adults.  Methods : We conducted a match-controlled cohort trial and participants were assigned to either the training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group. INT performed 30-s WAnT bouts three times a day in the morning, afternoon and evening with each bout separated by ~4 h of rest, performed for 3 days a week for 6 weeks. Criterion measures of peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey were assessed before and after 6 weeks in both groups.  Results : Absolute VO 2peak  increased by 8.3 ± 7.0% ( p  < 0.001) after INT  vs . 0.9 ± 6.1% in CON ( p  = 0.41) group. Maximal voluntary contraction at 30°·s -1  of the dominant lower-limb flexors in INT increased significantly post-training ( p  = 0.03). There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  Conclusion s : The results indicate that 6 weeks of dispersed sprint cycle training increased cardiorespiratory fitness and dynamic leg strength but had minimal impact on insulin sensitivity, blood lipids and quality of life in the exercising individuals.",2020,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","['Healthy Adults', 'healthy adults']","['Six-Week Dispersed Wingate-Cycle Training Protocol', 'training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group', 'dispersed sprint cycle training', 'CON', 'six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol']","['Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life', 'peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey', 'cardiorespiratory fitness and dynamic leg strength', 'peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life', 'cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures', 'insulin sensitivity, blood lipids and quality of life', 'Absolute VO 2peak', 'Maximal voluntary contraction']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",,0.019415,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","[{'ForeName': 'Chun Hou', 'Initials': 'CH', 'LastName': 'Wun', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Mandy Jiajia', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Boon Hor', 'Initials': 'BH', 'LastName': 'Ho', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'McGeough', 'Affiliation': 'ActiveSG, Active Health Division, Sport Singapore, Singapore 397630, Singapore.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Abdul Rashid', 'Initials': 'AR', 'LastName': 'Aziz', 'Affiliation': 'Sport Science and Sport Medicine, Singapore Sport Institute, Sport Singapore, Singapore 397630, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17134860']
2378,32648203,Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0469216,,"[{'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology, Mount Sinai Medical Center of Florida, Miami, FL, USA. rubenschwartz@yahoo.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Urits', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Viswanath', 'Affiliation': 'Valley Anesthesiology and Pain Consultants, Envision Physician Services, Phoenix, AZ, USA.'}]",Pain and therapy,['10.1007/s40122-020-00181-5']
2379,32648204,Author's Response to: 'Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study'.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0419255,,"[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Weiser', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany. robert1.lange@sanofi.com.'}]",Pain and therapy,['10.1007/s40122-020-00182-4']
2380,32648390,[ Yin - yang  balance penetrating acupuncture combined with rehabilitation training on upper limb spasticity in stroke hemiplegia].,"OBJECTIVE


To compare the therapeutic effect of  yin - yang  balance penetrating acupuncture combined with rehabilitation training and single rehabilitation training on upper limb spasticity in patients with stroke hemiplegia.
METHODS


A total of 60 patients with upper limb spasticity of stroke hemiplegia were randomized into an observation group and a control group, 30 cases in each one. On the basis of conventional western medication, rehabilitation training was adopted in the control group. On the basis of treatment in the control group,  yin - yang  balance penetrating acupuncture was applied from Jianyu (LI 15) to Binao (LI 14), Quchi (LI 11) to Shaohai (HT 3), Yanglingquan (GB 34) to Yinlingquan (SP 9), Xuanzhong (GB 39) to Sanyinjiao (SP 6), etc. of the affected side in the observation group. The treatment was given once a day, 5 days were as one course, with a 2-day interval between two courses, 4 courses were required in both groups. The classification of modified Ashworth spasticity scale (MAS), surface integrated electromyogram (iEMG) of affected upper limb and the scores of National Institute of Health stroke scale (NIHSS), Fugl-Meyer assessment (FMA) of upper limb and modified Barthel index (MBI) before and after treatment were observed, the therapeutic effect was evaluated in both groups.
RESULTS


①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis brevis were increased in both groups ( P <0.05), and the variations of iEMG of above muscles on the affected side in the observation group were larger than those in the control group ( P <0.05). ②After treatment, the scores of NIHSS were decreased ( P <0.05), the scores of FMA, MBI were increased in both groups ( P <0.05), and the variations of NIHSS, FMA and MBI scores were larger than those in the control group ( P <0.05). ③The total effective rate was 93.3% (28/30) in the observation group, which was superior to 70.0% (21/30) in the control group ( P <0.05).
CONCLUSION


Yin - yang  balance penetrating acupuncture combined with rehabilitation training can improve upper limb spasticity, heighten the motor function of upper limb and daily self care in patients with stroke hemiplegia, its therapeutic effect is superior to single rehabilitation training.",2020,"①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis","['60 patients with upper limb spasticity of stroke hemiplegia', 'stroke hemiplegia', 'patients with stroke hemiplegia']","['yin - yang  balance penetrating acupuncture combined with rehabilitation training and single rehabilitation training', 'Yin - yang  balance', 'penetrating acupuncture combined with rehabilitation training', ' Yin - yang  balance penetrating acupuncture combined with rehabilitation training']","['total effective rate', 'variations of iEMG of above muscles on the affected side', 'MAS classification', 'variations of NIHSS, FMA and MBI scores', 'scores of NIHSS', 'scores of FMA, MBI', 'maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis', 'modified Ashworth spasticity scale (MAS), surface integrated electromyogram (iEMG) of affected upper limb and the scores of National Institute of Health stroke scale (NIHSS), Fugl-Meyer assessment (FMA) of upper limb and modified Barthel index (MBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0085256', 'cui_str': 'Yin-Yang'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",60.0,0.0161392,"①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis","[{'ForeName': 'Jin-Mei', 'Initials': 'JM', 'LastName': 'Zhu', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhuang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Xue-Xin', 'Initials': 'XX', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Hai-Ying', 'Initials': 'HY', 'LastName': 'Zhu', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190531-k0005']
2381,32648391,[Therapeutic effect of herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points on diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency].,"OBJECTIVE


To observe the clinical therapeutic effect of herb-separated moxibustion at Jinsuo (GV 8)- eight-diagram points on diarrhea-type irritable bowel syndrome (IBS-D) of liver stagnation and spleen deficiency as compared with oral administration of pinaverium bromide tablets and Chinese herbal decoction,  tongxieyaofang .
METHODS


A total of 126 patients with IBS-D of liver stagnation and spleen deficiency were randomized into a herb-separated moxibustion group (moxibustion group), a western medication group and a Chinese herbal medication group, 42 cases in each one. In the moxibustion group, the herb-separated moxibustion was applied to Jinsuo (GV 8)-eight-diagram points. The herbs in  tongxieyaofang  (fried  rhizoma atractylodis macrocephalae , fried  radix paeoniae alba ,  pericarpium citri reticulatae  and  radix saposhnikoviae ) were ground into herbal paste and the paste was put on Jinsuo (GV 8)-eight-diagram points. The suspending moxibustion was exerted over the points for 40 min, once daily. In the western medication group, pinaverium bromide tablets were taken orally, 50 mg each time, three times a day. In the Chinese herbal medication group, the decoction of  tongxieyaofang  was taken orally, one dose a day, taking separately in two times. The duration of treatment was 8 weeks in each group. Before and after treatment, the symptom score of traditional Chinese medicine (TCM), gastrointestinal (GI) symptom score, the score of IBS symptom severity scale (IBS-SSS) and the score of IBS quality of life (IBS-QOL) scale were observed in patients of each group separately. The clinical therapeutic effect was evaluated.
RESULTS


After treatment, the scores of TCM symptoms, GI symptom scores and IBS-SSS scores were all obviously reduced in each group ( P <0.05). Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05). After treatment, the scores of each of eight subscale structures of IBS-QOL scale, named dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual intercourse and relationship, were all increased obviously in each group ( P <0.05). The scores of each of eight subscale structures in the moxibustion group were higher than the western medication group and the Chinese herbal medication group respectively ( P <0.05). The total effective rate was 92.9% (39/42) in the moxibustion group, higher than 71.4% (30/42) in the western medication group and 73.8% (31/42) in the Chinese herbal medication group respectively ( P <0.05).
CONCLUSION


Herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points remarkably relieves gastrointestinal symptoms and improves the quality of life in patients of diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency, and its clinical therapeutic effect is superior to oral administration of either pinaverium bromide tablets or  tongxieyaofang .",2020,Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05).,"['126 patients with IBS-D of liver stagnation and spleen deficiency', 'diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency', 'diarrhea-type irritable bowel syndrome (IBS-D) of liver stagnation and spleen deficiency']","['pinaverium bromide tablets', 'Herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points', 'pinaverium bromide tablets or  tongxieyaofang ', 'herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points', 'herb-separated moxibustion at Jinsuo (GV 8)- eight-diagram points', 'pinaverium bromide tablets and Chinese herbal decoction,  tongxieyaofang ', 'herb-separated moxibustion', 'herb-separated moxibustion group (moxibustion group), a western medication group and a Chinese herbal medication']","['symptom score of traditional Chinese medicine (TCM), gastrointestinal (GI) symptom score, the score of IBS symptom severity scale (IBS-SSS) and the score of IBS quality of life (IBS-QOL) scale', 'scores of TCM symptoms, GI symptom scores and IBS-SSS scores', 'quality of life', 'total effective rate', 'gastrointestinal symptoms', 'scores of each of eight subscale structures of IBS-QOL scale, named dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual intercourse and relationship', 'scores of each of eight subscale structures']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",126.0,0.0203212,Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05).,"[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, Tangshan Gongren Hospital, Tangshan 063000, Hebei Province, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Shi', 'Affiliation': 'Department of Spleen and Stomach Disorders, Tangshan Chinese Medicine Hospital, Tangshan 063000, Hebei Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190621-k0007']
2382,32648392,[Effect of acupuncture and estazolam on episodic memory and sleep structure in patients with chronic insomnia disorder: a randomized controlled trial].,"OBJECTIVE


To compare the effect on chronic insomnia disorder (CID) and influences on episodic memory and sleep structure between acupuncture and estazolam tablets.
METHODS


A total of 140 CID patients were randomized into a meridian-point group (46 cases, 1 case dropped off), a non-meridian-and-non-acupoint group (47 cases, 2 cases dropped off) and a medication group (47 cases, 2 cases dropped off). In the meridian-point group, Baihui (GV 20), Shenmen (HT 7), Sanyinjiao (SP 6), Zhaohai (KI 6) and Shenmai (BL 62) were selected and the routine acupuncture was applied. In the non-meridian-and-non-acupoint group, the needling technique was same as the meridian-point group. Acupuncture was given once daily for 4 weeks in the above two groups. In the medication group, estazolam tablets were administered orally, taken 1 to 2 mg per night, consecutively for 4 weeks. Before and after treatment, the changes in the following indexes were observed in each group, i.e. the score of insomnia severity index (ISI), the score of auditory verbal memory test (AVMT) and the relevant indexes of sleep structure [total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE) and the percentage of non rapid eye movement phase 1, 2 and 3 (N1, N2 and N3) and rapid eye movement time (REM) in TST].
RESULTS


After treatment, ISI scores were reduced in the meridian-point group and the medication group ( P <0.01), the score in the meridian-point group was lower than the medication group and the non-meridian-and-non- acupoint group respectively ( P <0.01) and that in the medication group was lower than the non-meridian-and-non-acupoint group ( P <0.01). After treatment, the score of each of immediate recall, short-term delayed recall, long-term delayed recall and delayed recognition of AVMT was increased in the meridian-point group and the medication group respectively ( P <0.01,  P <0.05) and the score of each item of AVMT in the meridian-point group was higher than the medication group and the non-meridian-and-non-acupoint group respectively ( P <0.01,  P <0.05). The scores of immediate memory and delayed recognition in the medication group were higher than the non-meridian-and-non-acupoint group respectively ( P <0.01). After treatment, SOL, WASO and N1% were all reduced ( P <0.01) and TST, SE, N3% and REM% were all increased ( P <0.01,  P <0.05) in the meridian-point group and the medication group, N2% in the meridian-point group was reduced ( P <0.01). After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01). After treatment, TST, SE and N3% in the meridian-point group and the medication group were all higher than the non-meridian-and-non-acupoint group respectively ( P <0.01,  P <0.05) and SOL, WASO and N1% were lower than the non-meridian-and-non-acupoint group respectively ( P <0.01). REM% in the meridian-point group was also higher than the non-meridion-and-non-acupoint group ( P <0.01), and N2% in the meridian-point group was also lower than the non-meridian-and-non-acupoint group ( P <0.01).
CONCLUSION


Compared with estazolam, acupuncture much better improves sleep quality and episodic memory in patients with chronic insomnia disorder, which is possibly related to the regulation of sleep structure of patients in treatment with acupuncture.",2020,"After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01).","['140 CID patients', 'patients with chronic insomnia disorder']","['acupuncture and estazolam tablets', 'estazolam tablets', 'acupuncture', 'acupuncture and estazolam', 'Acupuncture', 'estazolam, acupuncture', 'non-meridian-and-non-acupoint']","['sleep quality and episodic memory', 'ISI scores', 'score of each item of AVMT', 'score of insomnia severity index (ISI), the score of auditory verbal memory test (AVMT) and the relevant indexes of sleep structure [total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE) and the percentage of non rapid eye movement phase 1, 2 and 3 (N1, N2 and N3) and rapid eye movement time (REM', 'score of each of immediate recall, short-term delayed recall, long-term delayed recall and delayed recognition of AVMT', 'chronic insomnia disorder (CID', 'scores of immediate memory and delayed recognition', 'TST, SE, N3% and REM', 'REM', 'episodic memory and sleep structure']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1246115', 'cui_str': 'Estazolam Oral Tablet'}, {'cui': 'C0014892', 'cui_str': 'Estazolam'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",140.0,0.017784,"After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Guang-Lie', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Liu', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191208-k0006']
2383,32648397,[Effect of needle-knife as adjunctive therapy on dry eye syndrome].,"OBJECTIVE


To observe the clinical effect of needle-knife at cervical spine area as adjunctive therapy on dry eye syndrome.
METHODS


A total of 84 patients with dry eye syndrome were randomized into 3 groups, named group A, group B and group C, 28 cases in each one (1 case dropped off in the group A, 2 cases dropped off in both group B and C). In the group A, needle-knife was applied at the margo inferior of external occipital protuberance, the range of 4 cm bilateral to external occipital protuberance, the spinous process of C 2 , the range of 3 cm bilateral to 2 cm above C 2  spinous process, the range of 2 cm bilateral to C 2 , C 4 , C 6  spinous process for once a week; acupuncture was applied at Jingming (BL 1), Cuanzhu (BL 2), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3), Yanglao (SI 6), Ganshu (BL 18), Shenshu (BL 23), etc. for once a day, 6 times a week; sodium hyaluronate eye drop was given one drop once, 5-6 times a day. Treatment of acupuncture and sodium hyaluronate eye drop was given in the group B, sodium hyaluronate eye drop was given in the group C, the acupoints selection and the manipulation of acupuncture, the dosage of sodium hyaluronate eye drop were the same as the group A. One week was as one course and 3 courses were required in the 3 groups. SchirmerⅠtest (SⅠT), break-up time (BUT), scores of corneal fluorescein staining (CFS) and eye symptom before and after treatment were observed, the clinical effect was evaluated in the 3 groups.
RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01). The variations of SⅠT, BUT and the scores of CFS and eye symptom in the group A were greater than those in the group B and the group C ( P <0.01); the variations of above indexes in the group B were greater than those in the group C ( P <0.05,  P <0.01). The total effective rate was 94.4% (51/54) in the group A, which was superior to 78.8% (41/52) in the group B and 48.1% (25/52) in the group C ( P <0.01), and the total effective rate in the group B was superior to the group C ( P <0.01).
CONCLUSION


Needle-knife at cervical spine area as adjunctive therapy can relieve the clinical symptoms and improve the function of lacrimal gland in patients with dry eye syndrome.",2020,"RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01).","['patients with dry eye syndrome', 'dry eye syndrome', '84 patients with dry eye syndrome']","['acupuncture', 'needle-knife', 'acupuncture and sodium hyaluronate eye', 'Needle-knife']","['total effective rate', 'scores of CFS and eye symptom', 'BUT), scores of corneal fluorescein staining (CFS) and eye symptom', 'SchirmerⅠtest (SⅠT), break-up time ', 'variations of SⅠT, BUT and the scores of CFS and eye symptom', 'clinical effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",84.0,0.0191821,"RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01).","[{'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Weifang Traditional Chinese Hospital, Weifang 261041, Shandong Province, China.'}, {'ForeName': 'Nai-Gang', 'Initials': 'NG', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, China-Japan Friendship Hospital.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190706-0001']
2384,32648398,[Effect of  Cangguitanxue  acupuncture combined with suspension exercise therapy on chronic low back pain].,"OBJECTIVE


To observe the effect of  Cangguitanxue  acupuncture combined with suspension exercise therapy on the clinical symptoms, lumbar proprioception and trunk isokinetic muscle strength in patients with chronic low back pain.
METHODS


A total of 100 patients with chronic low back pain were randomly divided into an observation group and a control group, 50 cases in each group. The patients in the control group were treated with suspension exercise therapy, and the training exercise was selected according to the patient's exercise ability, the suspension exercise therapy was given once a day, three times a week, for totally 4 weeks. Based on the treatment of the control group, the patients in the observation group were treated with  Cangguitanxue  acupuncture at Dachangshu (BL 25), Weizhong (BL 40), Qihaishu (BL 24), Shenshu (BL 23) and  ashi  points, the acupuncture was given once a day, six times as a course of treatment, and a total of two courses of treatment were given. Before and after treatment, the scores of symptoms and signs, the pain rating index (PRI), present pain intensity (PPI) and the visual analogue scale (VAS) in the short-form of McGill pain questionnaire (SF-MPQ) in the two groups were recorded. The isokinetic feedback biomechanical test system was used to measure the lumbar proprioception and isokinetic muscle strength of the trunk, and the clinical efficacy of the two groups was evaluated.
RESULTS


The scores of symptoms and signs, PRI, PPI and VAS after treatment were lower than those before treatment in the two groups ( P <0.05), and those in the observation group were lower than those in the control group ( P <0.05). The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05). After treatment, the peak torque (PT) of musculus flexor and musculus extensor as well as peak torque/body weight (PT/BW) of musculus extensor were increased in the two groups, and the flexor/extensor (F/E) was reduced ( P <0.05). The PT of musculus flexor and musculus extensor as well as PT/BW of musculus extensor in the observation group were higher than those in the control group ( P <0.05), and F/E was lower than that in the control group ( P <0.05). The total effective rate was 90.0% (45/50) in the observation group, which was higher than 76.0% (38/50) in the control group ( P <0.05).
CONCLUSION


The  Cangguitanxue  acupuncture combined with suspension exercise therapy could effectively improve the symptoms and signs of patients with chronic low back pain, enhance the lumbar proprioception and trunk isokinetic muscle strength.",2020,"The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05).","['100 patients with chronic low back pain', 'patients with chronic low back pain']","['Cangguitanxue  acupuncture at Dachangshu (BL 25), Weizhong (BL 40), Qihaishu (BL 24), Shenshu (BL 23) and  ashi  points, the acupuncture', 'suspension exercise therapy', ""suspension exercise therapy, and the training exercise was selected according to the patient's exercise ability, the suspension exercise therapy"", 'Cangguitanxue  acupuncture combined with suspension exercise therapy']","['lumbar proprioception and trunk isokinetic muscle strength', 'lumbar proprioception and isokinetic muscle strength', 'scores of symptoms and signs, the pain rating index (PRI), present pain intensity (PPI) and the visual analogue scale (VAS) in the short-form of McGill pain questionnaire (SF-MPQ', 'total effective rate', 'scores of symptoms and signs, PRI, PPI and VAS', 'chronic low back pain', 'absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions', 'peak torque (PT) of musculus flexor and musculus extensor as well as peak torque/body weight (PT/BW) of musculus extensor', 'clinical symptoms, lumbar proprioception and trunk isokinetic muscle strength']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450634', 'cui_str': 'BL40 - popliteal crease'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0184507,"The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05).","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Ezhou Central Hospital, Ezhou 436000, Hubei Province, China.'}, {'ForeName': 'Jun-Song', 'Initials': 'JS', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, Wuhan Puren Hospital, Wuhan 430081, Hubei Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190624-k0004']
2385,32648409,"Use of biophysical treatment for the management of mild anxiety, depression and stress: a randomized controlled trial.",,2020,,"['mild anxiety, depression and stress']",['biophysical treatment'],[],"[{'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0959965,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Foletti', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Shenzhen University General Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baron', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Francone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Malandrone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ostacoli', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}]",Journal of biological regulators and homeostatic agents,['10.23812/20-132-L-57']
2386,32648429,Editorial Comment: Cardiovascular Morbi-dity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.,,2020,,['Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease'],['GnRH Agonist and GnRH Antagonist'],[],"[{'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]",[],,0.0524597,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.09']
2387,32648430,Editorial Comment: Randomised Trial of Adjuvant Radiotherapy Following Radical Pros-tatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension.,,2020,,['Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension'],"['Adjuvant Radiotherapy Following Radical Pros', 'tatectomy Versus Radical Prostatectomy Alone']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C3899187', 'cui_str': 'Extracapsular Extension'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]",[],,0.0471933,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.10']
2388,32648464,Management and experience of postural placement in postoperative mechanical ventilation of newborns.,"BACKGROUND


Congenital diaphragmatic hernia (CDH) is a neonatal condition that mainly occurs when the abdominal organs herniate into the thorax, obstructing the development of the lungs. Postoperative neonatal breathing disorder is one of the main causes of neonatal death. This study summarizes the postoperative nursing status of 30 cases of neonatal CDH in our hospital, and explores the effect of body position in mechanical ventilation care following CDH surgery.
METHODS


A total of 30 CHD children admitted in our hospital between June, 2018 and October, 2019 were included. The neonates were divided into preterm infant group (n=15) and full-term infant group (n=15). Each child was immediately transferred to the newborn intensive care unit (NICU) ward after surgery and received the hospital's NCIU special care. Besides routine nursing, each child was placed in a randomly selected primary position (the prone position or supine position). After 30 min, their oxygenation indexes were measured, and then their position (prone position or supine position) was changed. After 30 min, the neonates' oxygenation indicators were measured again. A hospital-made satisfaction questionnaire was used to evaluate the parents' satisfaction with nursing care.
RESULTS


Two children died of respiratory failure (one in the preterm group and one in the full-term group), and the rest were in a stable condition after surgery. There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05). In both groups, the partial pressure of oxygen in arterial blood (PaO2), partial pressure of oxygen in arterial blood/fraction of inspiration O2 (PaO2/FiO2), and partial pressure of oxygen in arterial blood/partial pressure of oxygen in the alveolar gas (PaO2/PAO2) in prone position were significantly higher than those in supine position (P<0.05); the alveolar-arterial oxygen difference (A-aDO2) was significantly lower than that in the supine position (0.05).
CONCLUSIONS


The prone position can improve the oxygenation index of children after surgery, and improve their respiratory system function. This method is suitable for newborn postoperative NICU care.",2020,"There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05).","['30 CHD children admitted in our hospital between June, 2018 and October, 2019 were included', 'postoperative mechanical ventilation of newborns', 'Congenital diaphragmatic hernia (CDH']","['postural placement', ""newborn intensive care unit (NICU) ward after surgery and received the hospital's NCIU special care""]","['respiratory failure', 'alveolar-arterial oxygen difference (A-aDO2', 'rates of parent satisfaction', 'partial pressure of oxygen in arterial blood (PaO2), partial pressure of oxygen in arterial blood/fraction of inspiration O2 (PaO2/FiO2), and partial pressure of oxygen in arterial blood/partial pressure of oxygen in the alveolar gas (PaO2/PAO2) in prone position']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]",30.0,0.0439864,"There was no significant difference between the rates of parent satisfaction in the two groups (preterm infant group: 96.67% verse full-term group: 93.33%, P>0.05).","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Outpatient, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Outpatient, Huai'an Maternal and Child Health Care Center, Huai'an, China.""}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Sterilization Supply Room, Huai'an Maternal and Child Health Care Center, Huai'an, China. zya0626@163.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1003']
2389,32648662,The effect of Losartan on the recoverability of renal function in anuric and oliguric patients with solitary obstructed kidney: A double blind randomized placebo-controlled trial.,"OBJECTIVES


To assess the role of Angiotensin receptor blockade (ARB), losartan, on the recoverability of renal function after deobstruction in anuric and oliguric patients.
MATERIALS AND METHODS


This is a double-blind randomized placebo-controlled trial on anuric or oliguric patients with calculuar obstruction of solitary kidney. Patients with anomalous kidney or those with ASA score of >3 were excluded. After relief of obstruction, patients have been allocated to receive either losartan potassium 25 mg or placebo for 3 months. Serum creatinine (S.creat), renographic glomerular filtration rate (Re GFR) were measured at nadir and after 3 months. Changes of S.creat and Re GFR were calculated by subtracting the values at nadir level from those at 3 months. Improvement, stabilization or deterioration of S.creat and Re GFR were defined as percentage increase or decrease from nadir level ≥10%, while changes <10% were considered as stabilization.
RESULTS


A total of 76 patients had completed 3 months follow-up. Demographics and perioperative data were comparable in both groups. S.creat change (median, range) were -1.05 (-1.8, 0.4) and -0.5 (-1.3, 0.1) mg/dl in losartan and placebo groups, respectively p=0.07. Losartan group had improvement and deterioration of Re GFR in 26 (59.1%) and 6 (13.6%) versus 8 (25%) and 10 (31.3%) patients in placebo group, respectively (p=0.01). Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32) ml/min in the placebo (p=0.004).
CONCLUSIONS


In anuric and oliguric patients, losartan treatment contributes to renal function recoverability after relief of calculuar obstruction of the solitary kidney.",2020,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","['76 patients had completed 3 months follow-up', 'Patients with anomalous kidney or those with ASA score of >3 were excluded', 'anuric and oliguric patients with solitary obstructed kidney', 'anuric and oliguric patients', 'oliguric patients with calculuar obstruction of solitary kidney']","['Angiotensin receptor blockade (ARB), losartan', 'Losartan', 'losartan potassium 25 mg or placebo', 'losartan', 'placebo']","['renal function', 'enhanced Re GFR', 'Serum creatinine (S.creat), renographic glomerular filtration rate (Re GFR', 'deterioration of Re GFR', 'Changes of S.creat and Re GFR', 'Improvement, stabilization or deterioration of S.creat and Re GFR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C2912327', 'cui_str': 'Losartan Potassium 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",76.0,0.454264,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Elkappany', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkarta', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Sheashaa', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Osman', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology department. Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.15168']
2390,32648790,Changes in inflammatory biomarkers are related to the antidepressant effects of Ayahuasca.,"BACKGROUND


Ayahuasca is a traditional Amazon brew and its potential antidepressant properties have recently been explored in scientific settings. We conducted a double-blind placebo-controlled trial of ayahuasca with treatment-resistant depression patients ( n  = 28) and healthy controls ( n  = 45).
AIMS


We are evaluating the blood inflammatory biomarkers: C-reactive protein and interleukin 6, as a potential consequence of ayahuasca intake and their correlation with serum cortisol and brain-derived neurotrophic factor levels. Blood samples were collected at pre-treatment and 48 hours after substance ingestion to assess the concentration of inflammatory biomarkers, together with administration of the Montgomery-Åsberg Depression Rating Scale.
RESULTS


At pre-treatment, patients showed higher C-reactive protein levels than healthy controls and a significant negative correlation between C-reactive protein and serum cortisol levels was revealed ( rho  = -0.40,  n  = 14). C-reactive protein in those patients was not correlated with Montgomery-Åsberg Depression Rating Scale scores. We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo. Patients treated with ayahuasca showed a significant correlation ( rho  = + 0.57) between larger reductions of C-reactive protein and lower depressive symptoms at 48 hours after substance ingestion (Montgomery-Åsberg Depression Rating Scale). No significant result with respect to interleukin 6 and brain-derived neurotrophic factor was found. Furthermore, these biomarkers did not predict the antidepressant response or remission rates observed.
CONCLUSIONS


These findings enhance the understanding of the biological mechanisms behind the observed antidepressant effects of ayahuasca and encourage further clinical trials in adults with depression.",2020,"We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo.","['adults with depression', 'with treatment-resistant depression patients ( n  = 28) and healthy controls ( n  = 45']","['ayahuasca', 'placebo']","['C-reactive protein and lower depressive symptoms', 'C-reactive protein and serum cortisol levels', 'Blood samples', 'antidepressant response or remission rates', 'interleukin 6 and brain-derived neurotrophic factor', 'C-reactive protein', 'C-reactive protein levels', 'Montgomery-Åsberg Depression Rating Scale scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0309995,"We observed a significant reduction of C-reactive protein levels across time in both patients and controls treated with ayahuasca, but not with placebo.","[{'ForeName': 'Nicole Leite', 'Initials': 'NL', 'LastName': 'Galvão-Coelho', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ana Cecília', 'Initials': 'AC', 'LastName': 'de Menezes Galvão', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Raíssa Nóbrega', 'Initials': 'RN', 'LastName': 'de Almeida', 'Affiliation': 'Department of Physiology and Behavior, Laboratory of Hormone Measurement, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Campos Braga', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lobão Soares', 'Affiliation': 'National Science and Technology Institute for Translational Medicine, Natal, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Maia-de-Oliveira', 'Affiliation': 'National Science and Technology Institute for Translational Medicine, Natal, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'School of Social and Political Science, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Westmead, Australia.'}, {'ForeName': 'Draulio Barros', 'Initials': 'DB', 'LastName': 'de Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120936486']
2391,32648810,Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms:  Post-hoc  analysis of short- and long-term studies.,"BACKGROUND


The treatment of patients with severe schizophrenia symptoms can be complicated and expensive.
AIMS


The purpose of this study was to evaluate the short- and long-term effects of brexpiprazole in patients with schizophrenia presenting with severe symptoms.
METHODS


Data were pooled from three six-week, randomized, double-blind, placebo-controlled studies and two 52-week, open-label extension studies. In the short-term studies, 1405 patients received placebo or brexpiprazole 2-4 mg/day; 412 brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day. More severe symptoms were defined as a Positive and Negative Syndrome Scale Total score >95 (median score at baseline). Outcomes included change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores.
RESULTS


Brexpiprazole improved Positive and Negative Syndrome Scale Total score over 6 weeks among more severely ill patients, with a least squares mean difference versus placebo of -6.76 (95% confidence limits: -9.80, -3.72;  p <0.0001; Cohen's  d : 0.43). Brexpiprazole also improved Personal and Social Performance scale score over 6 weeks in more severely ill patients (least squares mean difference: 4.38; limits: 2.14, 6.62;  p =0.0001; Cohen's  d : 0.38). Improvement of functioning was greatest in the 'Self-care' domain, followed by 'Personal and social relationships'. Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6. Improvements were maintained over 58 weeks. No new safety or tolerability concerns were observed.
CONCLUSIONS


Brexpiprazole is an efficacious and well-tolerated treatment for schizophrenia in patients with more severe, and less severe, symptoms.",2020,"Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6.","['patients with schizophrenia presenting with severe symptoms', '1405 patients received', 'patients with severe schizophrenia symptoms']","['brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day', 'Brexpiprazole', 'brexpiprazole', 'placebo or brexpiprazole', 'placebo']","['change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores', 'Positive and Negative Syndrome Scale Total and Personal and Social Performance scale', 'Personal and Social Performance scale score', 'severe symptoms', 'Efficacy and safety', 'Positive and Negative Syndrome Scale Total score', 'new safety or tolerability concerns']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1405.0,0.236428,"Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Meade', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Meehan', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': 'Department of Psychiatry and Hotchkiss Brain Institute, University of Calgary, Calgary, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120936485']
2392,32648821,Impacts of prolonged sitting with mild hypercapnia on vascular and autonomic function in healthy recreationally active adults.,"Prolonged sitting, which is known to impair peripheral vascular function often occurs in spaces (e.g. offices) with mild hypercapnic atmospheres. However, the effects of prolonged sitting in hypercapnic conditions on vascular function are unknown. Therefore, the purpose of this study was to investigate the effects of prolonged sitting in mild hypercapnic conditions on vascular and autonomic function in humans.
METHODS


12 healthy young adults participated in two experimental visits which consisted of sitting for 2.5 hours in a control condition (PSIT) or a mild hypercapnic condition (HCAP, CO2=1,500 ppm). During each visit, heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow mediated dilation (FMD), and near infrared spectroscopy (NIRS) were assessed before and after prolonged sitting.
RESULTS


Sitting significantly decreased AIx in both groups (P<0.05). Brachial and popliteal FMD were reduced with sitting (P<0.05), and the reduction in popliteal FMD was amplified by HCAP (P<0.05). Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05). However, microvascular reoxygenation upon cuff release was slower only in HCAP (P<0.05). HRV, HR, BP, and PWV did not significantly change with sitting in either group (P>0.05).
CONCLUSION


Prolonged sitting attenuated both brachial and popliteal endothelial function and was associated with perturbed microcirculation. Additionally, mild hypercapnic conditions further impaired peripheral endothelial and microvascular function. Together, these findings suggest that prolonged sitting is accompanied by a host of deleterious effects on the vasculature, which are exacerbated by mild hypercapnia.",2020,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"['12 healthy young adults', 'healthy recreationally active adults', 'humans']","['experimental visits which consisted of sitting for 2.5 hours in a control condition (PSIT) or a mild hypercapnic condition (HCAP, CO2=1,500 ppm', 'prolonged sitting with mild hypercapnia']","['reduction in popliteal FMD', 'Prolonged sitting attenuated both brachial and popliteal endothelial function', 'peripheral endothelial and microvascular function', 'Brachial and popliteal FMD', 'HRV, HR, BP, and PWV', 'microvascular reoxygenation upon cuff release', 'vascular and autonomic function', 'Baseline microvascular oxygenation', 'heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow mediated dilation (FMD), and near infrared spectroscopy (NIRS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0056451', 'cui_str': 'H-CAP protocol'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",12.0,0.0577376,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"[{'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, United States.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, United States.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, United States.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, United States.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Wiess School of Natural Sciences, Rice University, United States.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska, Omaha, United States.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00354.2020']
2393,32648835,Preoperative education improves the preparedness for extubation at emergence from general anaesthesia!,"BACKGROUND


Preoperative patient education is an essential responsibility of any healthcare provider, especially an anaesthetist, and is beneficial for perioperative outcome. A smooth emergence and extubation is a clinical skill that needs to be mastered by an anaesthetist. The aim of this study was to analyse whether a detailed preoperative patient education improves the quality of and preparedness for extubation at emergence from general anaesthesia.
METHODS


One hundred patients were randomly assigned to two groups. The study group received a detailed preoperative patient education and counselling about the mode of anaesthesia, extubation process and their expected response at extubation while the control group received the routine counselling. The Extubation Quality Scale at emergence and the recovery profile in the post anaesthesia care unit were assessed for both groups.
RESULTS


The primary outcome was a better quality of extubation in the patients who received a detailed preoperative patient education. The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001). The endotracheal tube tolerance at a minimum alveolar concentration of ≤0.2 and response to verbal commands at extubation were better for the study group (p < 0.05) besides an earlier discharge from post anaesthesia care unit (p < 0.005).
CONCLUSION


Preoperative patient education improves the patients' preparedness for and quality of extubation and recovery from general anaesthesia .",2020,The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001).,['One hundred patients'],"['detailed preoperative patient education and counselling about the mode of anaesthesia, extubation process and their expected response at extubation while the control group received the routine counselling']","['Extubation Quality Scale', 'quality of and preparedness for extubation', 'better quality of extubation', 'endotracheal tube tolerance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",100.0,0.0505093,The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001).,"[{'ForeName': 'Zaka', 'Initials': 'Z', 'LastName': 'Sameen', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Khan', 'Initials': 'K', 'LastName': 'Talib', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Shaqul Q', 'Initials': 'SQ', 'LastName': 'Wani', 'Affiliation': 'Department of Radiation Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Muntasir', 'Initials': 'M', 'LastName': 'Ashraf', 'Affiliation': 'Department of Orthopaedics, Asian Institute of Medical Sciences, Faridabad, India.'}, {'ForeName': 'Showkat H', 'Initials': 'SH', 'LastName': 'Nengroo', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}]",Journal of perioperative practice,['10.1177/1750458920936213']
2394,32648838,A prospective randomised study on efficacy of music for decreasing preoperative anxiety in children.,"BACKGROUND


The operating room can be a frightening environment for paediatric patients. This study investigated whether music medicine can mitigate preoperative anxiety in children.
MATERIALS AND METHODS


One hundred and fifty children undergoing general anaesthesia were randomised to listen to music of the child's choice, lullaby music or no music before induction. Heart rates were measured in the waiting room, upon first entry into the operating room and just prior to induction.
RESULTS


There was no significant difference in average heart rate change from the waiting room to induction in the patient choice, lullaby and control groups. Older age was associated with higher heart rate changes between baseline and entering the operating room. Pharmacologic sedation showed a significant beneficial effect on heart rate change at induction.
CONCLUSION


Use of music medicine in the operating room does not show efficacy to reduce anxiety in children based on heart rate changes.",2020,"CONCLUSION


Use of music medicine in the operating room does not show efficacy to reduce anxiety in children based on heart rate changes.","['One hundred and fifty children undergoing general anaesthesia', 'paediatric patients', 'children']","[""listen to music of the child's choice, lullaby music or no music before induction"", 'music medicine']","['heart rate changes', 'average heart rate change', 'preoperative anxiety', 'Heart rates', 'heart rate change']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",150.0,0.0573255,"CONCLUSION


Use of music medicine in the operating room does not show efficacy to reduce anxiety in children based on heart rate changes.","[{'ForeName': 'Cynthia V', 'Initials': 'CV', 'LastName': 'Nguyen', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Shriners for Children Medical Center - Pasadena, Pasadena, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Alvin', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, USA.""}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'George', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, USA.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Gilmore', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, USA.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tripi', 'Affiliation': ""Division of Pediatric Anesthesia, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, USA.""}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Liu', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, USA.""}]",Journal of perioperative practice,['10.1177/1750458920939780']
2395,32648861,Effect of coconut oil on weight loss and metabolic parameters in men with obesity: a randomized controlled clinical trial.,"Coconut oil appears to help in weight loss and improve metabolic parameters associated with obesity. We evaluate the influence of coconut oil on the body composition, lipid profile and glycemia in men with obesity. A controlled, randomized clinical trial was performed with 29 adult men affected by obesity. They were randomized between two groups receiving a daily intake of 1 tablespoon (12 mL) of extra virgin coconut oil (CO, n = 15) or soybean oil (SO, n = 14), and an isoenergetic balanced diet. The anthropometric profile, lipid profile and glycaemia were evaluated at the baseline and 45 days after intervention. The Mann-Whitney test was performed to compare the groups, and the Wilcoxon test was performed to compare the times. We considered a value of p < 0.05 as significant. There was no difference in anthropometric variables between the groups before and after intervention. The level of HDL cholesterol increased (3.67 ± 8.08 versus -3.79 ± 10.98, p = 0.02) and the TC/HDL cholesterol ratio decreased (-0.63 ± 0.82 versus 0.23 ± 0.80, p = 0.03) in the CO group, compared to the SO group. Coconut oil included in the isoenergetic balanced diet could increase HDL cholesterol and decrease the TC/HDL cholesterol ratio in men with obesity.",2020,"The level of HDL cholesterol increased (3.67 ± 8.08 versus -3.79 ± 10.98, p = 0.02) and the TC/HDL cholesterol ratio decreased (-0.63 ± 0.82 versus 0.23 ± 0.80, p = 0.03) in the CO group, compared to the SO group.","['29 adult men affected by obesity', 'men with obesity']","['isoenergetic balanced diet', 'coconut oil', 'Coconut oil', 'daily intake of 1 tablespoon (12 mL) of extra virgin coconut oil (CO, n = 15) or soybean oil']","['weight loss and metabolic parameters', 'level of HDL cholesterol', 'anthropometric variables', 'anthropometric profile, lipid profile and glycaemia', 'body composition, lipid profile and glycemia', 'HDL cholesterol', 'weight loss', 'TC/HDL cholesterol ratio']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1532188', 'cui_str': 'Tablespoonful - unit of product usage'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",29.0,0.0269566,"The level of HDL cholesterol increased (3.67 ± 8.08 versus -3.79 ± 10.98, p = 0.02) and the TC/HDL cholesterol ratio decreased (-0.63 ± 0.82 versus 0.23 ± 0.80, p = 0.03) in the CO group, compared to the SO group.","[{'ForeName': 'Christine Érika', 'Initials': 'CÉ', 'LastName': 'Vogel', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. louisecrovesy@yahoo.com.br.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Crovesy', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. louisecrovesy@yahoo.com.br.'}, {'ForeName': 'Eliane Lopes', 'Initials': 'EL', 'LastName': 'Rosado', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. louisecrovesy@yahoo.com.br.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Soares-Mota', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. louisecrovesy@yahoo.com.br.'}]",Food & function,['10.1039/d0fo00872a']
2396,32648924,Association of Adherence to Weight Telemonitoring With Health Care Use and Death: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Adherence to telemonitoring may be associated with heart failure exacerbation but is not included in telemonitoring algorithms.
Objective


To assess whether telemonitoring adherence is associated with a patient's risk of hospitalization, emergency department visit, or death.
Design, Setting, and Participants


This post hoc secondary analysis of the Better Effectiveness After Transition-Heart Failure randomized clinical trial included patients from 6 academic medical centers in California who were eligible if they were hospitalized for decompensated heart failure and excluded if they were discharged to a skilled nursing facility, were expected to improve because of a medical procedure, or did not have the cognitive or physical ability to participate. The trial compared a telemonitoring intervention with usual care for patients with heart failure after hospital discharge from October 12, 2011, to September 30, 2013. Data analysis was performed from November 8, 2016, to May 10, 2019.
Interventions


The intervention group (n = 722) received heart failure education, telephone check-ins, and a wireless telemonitoring system that allowed the patient to transmit weight, blood pressure, heart rate, and selected symptoms. The control group (n = 715) received usual care. Patients were followed up for 180 days after discharge.
Main Outcomes and Measures


The main outcome was within-person risk of hospitalization, emergency department visit, or death by week during the study period. Poisson regression was used to determine the within-person association of adherence to daily weighing with the risk of experiencing these events in the following week.
Results


Among the 538 participants (mean [SD] age, 70.9 [14.1] years; 287 [53.8%] male; 269 [50.7%] white) in the present analysis, adherence was lowest during the first week after enrollment but steadily increased, peaking between days 26 and 60 at 69%, or 371 transmissions. Adherence to weight telemonitoring was associated with events in the following week; an increase in adherence by 1 day was associated with a 19% decrease in the rate of death in the following week (incidence rate ratio, 0.81; 95% CI, 0.73-0.90) and an 11% decrease in the rate of hospitalization (incidence rate ratio, 0.89; 95% CI, 0.86-0.91). Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
Conclusions and Relevance


In this study, lower adherence to weight telemonitoring in a given week was associated with an increased risk of subsequent hospitalization or death in the following week. It is unlikely that this is a result of the telemonitoring intervention; rather, adherence may be an important factor associated with a patient's health status.",2020,"Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
","['patients with heart failure after hospital discharge from October 12, 2011, to September 30, 2013', 'patients from 6 academic medical centers in California who were eligible if they were hospitalized for decompensated heart failure and excluded if they were discharged to a skilled nursing facility, were expected to improve because of a medical procedure, or did not have the cognitive or physical ability to participate', '538 participants (mean [SD] age, 70.9 [14.1] years; 287 [53.8%] male; 269 [50.7%] white', 'Death']","['telemonitoring intervention with usual care', 'heart failure education, telephone check-ins, and a wireless telemonitoring system', 'usual care']","['adherence', 'person risk of hospitalization, emergency department visit, or death', 'rate of death', 'risk of subsequent hospitalization or death', 'rate of hospitalization', 'Adherence to weight telemonitoring', 'rates of emergency department visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C1272747', 'cui_str': 'Expected to improve'}, {'cui': 'C0199171', 'cui_str': 'Medical procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1828111', 'cui_str': 'Heart failure education'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.230963,"Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02).
","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': 'Center for Health and Technology, Department of Pediatrics, University of California, Davis, Sacramento.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, Department of Pediatrics, University of California, Davis, Sacramento.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': 'Adventist Heart and Vascular Institute, St Helena, California.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': 'Center for Healthcare Policy and Research, Department of Public Health Sciences, University of California, Davis, Sacramento.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California, Los Angeles.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego School of Medicine, La Jolla.'}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': 'Sue and Bill Gross School of Nursing, University of California, Irvine.'}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': 'Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': 'Department of Medicine, University of California, San Francisco School of Medicine, San Francisco.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': 'Center for Healthcare Policy and Research, Division of General Medicine, University of California, Davis, Sacramento.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.10174']
2397,32648983,Ketamine mouthwash versus placebo in the treatment of severe oral mucositis pain in children with cancer: A randomized double-blind placebo-controlled trial.,"BACKGROUND AND AIMS


Oral mucositis (OM) is a common and distressing toxicity in children on chemotherapy. There are a limited number of safe and effective therapeutic options available for OM. Ketamine oral rinse has shown promising results in a few studies in adults. This randomized, double-blind placebo-controlled trial aimed to test the efficacy of ketamine mouthwash in reducing chemotherapy-induced severe OM pain in children.
METHODS


Children aged 8-18 years with severe OM were randomized to a single dose of ketamine mouthwash (4 mg/mL solution; dose 1 mg/kg) or a placebo. A sample size of 44 patients was determined. Pain score (6-point faces scale) was noted at baseline and 15, 30, 45, 60, 120, 180, and 240 min. The outcome variables were a reduction in pain score, need for rescue medications, and adverse events.
RESULTS


The baseline characteristics were comparable in the two groups. The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points. Rescue pain medication (at 60 min) was required in 13.6% in the ketamine group and 18.2% in the placebo group (P = 1.000). No significant adverse events were observed.
CONCLUSIONS


Among children on cancer chemotherapy with severe OM, ketamine mouthwash at a dose of 1 mg/kg did not significantly reduce OM pain. It did not decrease the need for rescue pain medications. Further research is warranted to test higher doses of ketamine for a clinically significant effect.",2020,"The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points.","['children with cancer', 'children on chemotherapy', 'Children aged 8-18 years with severe OM', 'children']","['Ketamine oral rinse', 'ketamine mouthwash (4\xa0mg/mL solution; dose 1\xa0mg/kg) or a placebo', 'ketamine', 'Ketamine mouthwash versus placebo', 'ketamine mouthwash', 'placebo']","['mean OM pain', 'Pain score (6-point faces scale', 'reduction in pain score, need for rescue medications, and adverse events', 'rescue pain medications', 'severe oral mucositis pain', 'adverse events', 'severe OM pain', 'Rescue pain medication', 'OM pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.776638,"The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points.","[{'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jagdish Prasad', 'Initials': 'JP', 'LastName': 'Meena', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Aditya Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, Dr. B.R.A. IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Thirumurthy', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Ocular Pharmacology and Pharmacy Division, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Seth', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Pediatric blood & cancer,['10.1002/pbc.28573']
2398,32648985,"Comparison of cernitin pollen extract vs tadalafil therapy for refractory chronic prostatitis/chronic pelvic pain syndrome: A randomized, prospective study.","AIMS


To compare the efficacy of cernitin pollen extract (cernitin) or tadalafil for treating persistent chronic pelvic pain despite α1-blocker monotherapy in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS).
METHODS


A total of 100 patients with refractory CP/CPPS despite ongoing α1-blocker monotherapy were randomized to receive add-on therapy with either cernitin (4 capsules/day) or tadalafil (5 mg/d) for 12 weeks. At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
RESULTS


The final analysis included 42 and 45 patients in the cernitin and tadalafil groups, respectively. Although the NIH-CPSI total, NIH-CPSI pain sub-score, and NIH-CPSI quality of life sub-score significantly improved in both groups, the cernitin (vs tadalafil) group showed significantly greater improvements in the NIH-CPSI total score (-6.8 vs -4.6; P = .02) and NIH-CPSI pain sub-score (-4.1 vs -1.5; P < .001). Half (50%) of the patients in the cernitin group showed a reduction greater than 50% in their NIH-CPSI pain sub-score; in the tadalafil group, only four patients (8.9%) showed ≥50% improvement (P < .001). In contrast, the improvement in LUTS was significantly superior in the tadalafil group.
CONCLUSION


Both cernitin and tadalafil significantly ameliorated chronic pelvic pain in patients with refractory CP/CPPS. The add-on of cernitin was more effective than tadalafil for pelvic pain and discomfort.",2020,"At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
","['patients with refractory CP/CPPS', '100 patients with refractory CP/CPPS despite ongoing α1-blocker monotherapy', 'refractory chronic prostatitis/chronic pelvic pain syndrome', 'men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS']","['cernitin (4 capsules/day) or tadalafil', 'tadalafil', 'cernitin pollen extract (cernitin) or tadalafil', 'cernitin and tadalafil', 'cernitin pollen extract vs tadalafil therapy']","['CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry', 'NIH-CPSI pain sub-score ', 'NIH-CPSI total score', 'NIH-CPSI total, NIH-CPSI pain sub-score, and NIH-CPSI quality of life sub-score', 'chronic pelvic pain', 'LUTS', 'pelvic pain and discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",100.0,0.0402854,"At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Funahashi', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Ishida', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tochigi', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}]",Neurourology and urodynamics,['10.1002/nau.24454']
2399,32649011,Early term elective Caesarean sections did not increase the risk of behavioural problems at six to eight years of age.,"AIM


Our aim was to explore the under-researched associations between an elective Caesarean section (C-section) at early term or full term gestation and behaviour at 6-8 years of age.
METHODS


We identified 1220 eligible children born by elective C-sections at Danish hospital from 2009-2011. Their mothers were randomised to elective C-sections at either 38+3 (early term) or 39+3 (full term) weeks of gestation. From December 2017 to August 2018 the parents completed the Strengths and Difficulties Questionnaire. The results were adjusted for maternal education, parity and the child's sex.
RESULTS


Of the 574 (45%) children followed up, 288 were delivered early term and 286 were delivered full term. The groups had similar baseline characteristics. There were no differences in the total difficulties score, subscale scores or the risk of being classified as having a possible or probable psychiatric disorder. Early term boys had a lower risk of being classified as having a possible or probable psychiatric disorder and early term girls had higher risk, but the results were not statistically significant.
CONCLUSION


We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early versus full term gestation.",2020,We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early versus full term gestation.,"['Of the 574 (45%) children followed up, 288 were delivered early term and 286 were delivered full term', '1220 eligible children born by elective C-sections at Danish hospital from 2009-2011']",['elective Caesarean section (C-section'],"['risk of behavioural problems', 'behaviour', 'lower risk of being classified as having a possible or probable psychiatric disorder', 'total difficulties score, subscale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",,0.0627165,We found no difference in behaviour at 6-8 years of age between children born by elective C-section at early versus full term gestation.,"[{'ForeName': 'Trine Muhs', 'Initials': 'TM', 'LastName': 'Nielsen', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Glavind', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Milidou', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Brink Henriksen', 'Affiliation': 'Perinatal Epidemiology Research Unit, Aarhus University, Aarhus, Denmark.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15468']
2400,32649015,"Acceptability and feasibility of a parent-targeted dietary intervention in young survivors of childhood cancer: ""Reboot"".","BACKGROUND


Assess the acceptability and feasibility of delivering Reboot, a telephone dietary intervention to parents of pediatric cancer survivors. The research question asks whether tailored dietary support is acceptable and feasible to deliver to parents of young cancer survivors who have recently completed cancer treatment?
PROCEDURE


Pre-post study. Nineteen parents of pediatric cancer survivors (aged 2-13 years) in remission, who had received cancer treatment at a tertiary children's hospital, less than 5 years prior to the intervention. Participants received four weekly 45-min telephone sessions led by a psychologist or dietitian and one postintervention booster session 6 weeks later. Sessions addressed strategies to increase children's vegetable and fruit intake.
RESULTS


Of the 19 parents who started the intervention, 14 completed all sessions within 8 weeks and 12 completed the booster session within 10 weeks. The mean session duration was 47 min. All participants reported that Reboot increased their confidence and knowledge about promoting healthy eating habits to their child.
CONCLUSIONS


Reboot is an acceptable intervention in young cancer survivors aimed at increasing vegetable and fruit intake after cancer treatment.
IMPLICATIONS FOR CANCER SURVIVORS


The results from the Reboot pilot provides preliminary evidence that a targeted intervention to improve the diets of childhood cancer survivors may be feasible with future modification.",2020,"RESULTS


Of the 19 parents who started the intervention","['young survivors of childhood cancer', 'parents of pediatric cancer survivors', ""Nineteen parents of pediatric cancer survivors (aged 2-13\xa0years) in remission, who had received cancer treatment at a tertiary children's hospital, less than 5\xa0years prior to the intervention"", 'young cancer survivors', 'FOR CANCER SURVIVORS', 'childhood cancer survivors', '19 parents who started the intervention', 'parents of young cancer survivors who have recently completed cancer treatment']","['parent-targeted dietary intervention', 'telephone dietary intervention', '45-min telephone sessions led by a psychologist or dietitian and one postintervention booster session 6\xa0weeks later']","['Acceptability and feasibility', 'mean session duration']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0280443,"RESULTS


Of the 19 parents who started the intervention","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Touyz', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Garnett', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Grech', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Paayal', 'Initials': 'P', 'LastName': 'Gohil', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cohn', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wakefield', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}]",Pediatric blood & cancer,['10.1002/pbc.28533']
2401,32649063,Efficacy of Home-Use Light-Emitting Diode Device at 637 and 854-nm for Facial Rejuvenation: A Split-Face Pilot Study.,"BACKGROUND


The use of light-emitting diode (LED) in combination wavelength for facial rejuvenation has been previously reported. Nowadays, there has been a growing market for home-use cosmetic devices because of its low-cost and convenience.
OBJECTIVE


To evaluate the efficacy and safety of home-use LED device on facial rejuvenation.
METHODS


This was a prospective split-face clinical trial with a total of 24 subjects, who presented with photo aging skin. All subjects were treated with the home-use LED device on the left side of their face, twice a week for 8 weeks. Primary outcomes measured in the study were the changes in the biophysical properties of the skin assessed with the following parameters: skin elasticity, skin hydration, texture and wrinkles. Evaluations were done at baseline, 2-, 4-, 6- and 8-week follow-up. Subjects' self-improvement scores and adverse reactions were also recorded.
RESULTS


All 24 subjects completed the study and attended all follow-up. Skin elasticity was significantly higher in the LED group compared to the control during the 6- and 8-week follow-up (p < 0.05). In the LED group, an image of the treated skin captured using Visioscan® showed improvement of the skin texture at 8-week follow-up. Majority of the subjects in the LED group scored good improvement on all follow-ups (37.5%, 41.7%, 58.3% and 62.5%) when compared to the baseline. No adverse reactions or pain were recorded in the study.
CONCLUSION


The home-use LED device with a combination wavelength of 637 and 854 nm, is safe and can be used as an adjunctive treatment for self-administered facial rejuvenation.",2020,"In the LED group, an image of the treated skin captured using Visioscan® showed improvement of the skin texture at 8-week follow-up.","['24 subjects, who presented with photo aging skin', 'All 24 subjects completed the study and attended all follow-up']","['home-use LED device', 'Home-Use Light-Emitting Diode Device', 'light-emitting diode (LED']","[""Subjects' self-improvement scores and adverse reactions"", 'Skin elasticity', 'biophysical properties of the skin assessed with the following parameters: skin elasticity, skin hydration, texture and wrinkles', 'efficacy and safety', 'adverse reactions or pain', 'skin texture']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}]",24.0,0.0396583,"In the LED group, an image of the treated skin captured using Visioscan® showed improvement of the skin texture at 8-week follow-up.","[{'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13613']
2402,32644833,Effects of Extended-Release Methylphenidate Treatment on Cognitive Task Performance in Children with Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder.,"Objective:  To examine the effectiveness of four doses of psychostimulant medication, combining extended-release methylphenidate (ER-MPH) in the morning with immediate-release MPH (IR-MPH) in the afternoon, on cognitive task performance.  Method:  The sample comprised 24 children (19 boys and 5 girls) who met the  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision  (DSM-IV-TR) criteria for an autism spectrum disorder (ASD) on the  Autism Diagnostic Interview-R  and the  Autism Diagnostic Observation Schedule , and had significant symptoms of attention-deficit/hyperactivity disorder (ADHD). This sample consisted of elementary school-age, community-based children (mean chronological age = 8.8 years, SD = 1.7; mean intelligence quotient = 85; SD = 16.8). Effects of placebo and three dose levels of ER-MPH (containing 0.21, 0.35, and 0.48 mg/kg equivalent of IR-MPH) on cognitive task performance were compared using a within-subject, crossover, placebo-controlled design. Each of the four MPH dosing regimens (placebo, low-dose MPH, medium-dose MPH, and high-dose MPH) was administered for 1 week; the dosing order was counterbalanced across children.  Results:  MPH treatment was associated with significant performance gains on cognitive tasks tapping sustained attention, selective attention, and impulsivity/inhibition. Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  Conclusion:  The results of this study suggest that MPH formulations are associated with significant improvements on cognitive task performance in children with ASD and ADHD.",2020,"Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  ","['children with ASD and ADHD', '24 children (19 boys and 5 girls) who met the  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision  (DSM-IV-TR) criteria for an autism spectrum disorder (ASD) on the  Autism Diagnostic Interview-R  and the  Autism Diagnostic Observation Schedule , and had significant symptoms of attention-deficit/hyperactivity disorder (ADHD', 'Children with Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder', 'elementary school-age, community-based children (mean chronological age\u2009=\u20098.8 years, SD\u2009=\u20091.7; mean intelligence quotient\u2009=\u200985; SD\u2009=\u200916.8']","['ER-MPH', 'IR-MPH', 'MPH dosing regimens (placebo, low-dose MPH, medium-dose MPH, and high-dose MPH', 'psychostimulant medication, combining extended-release methylphenidate (ER-MPH', 'Extended-Release Methylphenidate', 'placebo']","['cognitive tasks tapping sustained attention, selective attention, and impulsivity/inhibition', 'Cognitive Task Performance', 'cognitive task performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C4517591', 'cui_str': '16.8'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.130164,"Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  ","[{'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Pearson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Cynthia W', 'Initials': 'CW', 'LastName': 'Santos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Aman', 'Affiliation': 'Nisonger Center, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Nisonger Center, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lane', 'Affiliation': 'Department of Psychological Sciences and Department of Statistics, Rice University, Houston, Texas, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Loveland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Rosleen', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Casat', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': 'School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schachar', 'Affiliation': 'The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Bukstein', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lynne A', 'Initials': 'LA', 'LastName': 'Cleveland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0004']
2403,32644867,Therapeutic Effect of Corneal Crosslinking on Fungal Keratitis: Efficacy of Corneal Collagen Crosslinking as an Adjuvant Therapy for Fungal Keratitis in a Tertiary Eye Hospital in South India.,"PURPOSE


To evaluate the efficacy of CXL in treating fungal keratitis as an adjuvant therapy.
METHODS


Detailed clinical examination microbiological investigation was performed. Twenty fungal keratitis patients were recruited and randomized into two groups: group 1 (n= 11, standard antifungal), group 2 (n=9, corneal collagen crosslinking with standard antifungal). Corneal scraping and tear samples collected were subjected to real-time PCR targeting ITS, TLR analysis and cytokine analysis.
RESULTS


The mean time for complete resolution of ulcer for group 2 was significantly shorter compared to group 1 and the final mean BCVA was better for group 2. Expression of IL-1β, IL-8, IFN-γ significantly decreased immediately post CXL in group 2 patients. Significant downregulation of TLR 6, TLR-3, TLR-4 was observed 3-days post CXL compared to group 1 patients.
CONCLUSION


Adjuvant effect of CXL was significant in treating fungal keratitis compared to standalone antifungal treatment.",2020,"Significant downregulation of TLR 6, TLR-3, TLR-4 was observed 3-days post CXL compared to group 1 patients.
","['Fungal Keratitis', 'Twenty fungal keratitis patients', 'Fungal Keratitis in a Tertiary Eye Hospital in South India']","['corneal collagen crosslinking with standard antifungal', 'Corneal Collagen Crosslinking', 'Corneal Crosslinking', 'CXL']","['treating fungal keratitis', 'IFN-γ', 'Expression of IL-1β, IL-8', 'TLR 6, TLR-3, TLR-4', 'mean time for complete resolution of ulcer']","[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",20.0,0.0679806,"Significant downregulation of TLR 6, TLR-3, TLR-4 was observed 3-days post CXL compared to group 1 patients.
","[{'ForeName': 'Vimalin', 'Initials': 'V', 'LastName': 'Jeyalatha Mani', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Durgadevi', 'Initials': 'D', 'LastName': 'Parthasarathy', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Prema', 'Initials': 'P', 'LastName': 'Padmanabhan', 'Affiliation': 'Department of Cornea and Refractive Surgery, Medical Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Niveditha', 'Initials': 'N', 'LastName': 'Narayanan', 'Affiliation': 'Department of Cornea and Refractive Surgery, Medical Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Lakshmipathy', 'Affiliation': 'Department of Cornea and Refractive Surgery, Medical Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Saravana Kumar', 'Initials': 'SK', 'LastName': 'Pachayappan', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Padmapriya', 'Initials': 'P', 'LastName': 'Jayavel', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Kulandhai Lily', 'Initials': 'KL', 'LastName': 'Therese', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Hajib Narahari', 'Initials': 'HN', 'LastName': 'Rao Madhavan', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}, {'ForeName': 'Malathi', 'Initials': 'M', 'LastName': 'Jambulingam', 'Affiliation': 'L&T Microbiology Research Centre, Vision Research Foundation, Sankara Nethralaya , Chennai, India.'}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1770296']
2404,32644875,Effects of Estradiol Dose and Serum Estradiol Levels on Metabolic Measures in Early and Late Postmenopausal Women in the REPLENISH Trial.,"Background:  To identify the association of estradiol (E2) dose and serum E2 levels with metabolic measures in early (<6 years) compared with late (≥10 years) postmenopausal women from the REPLENISH trial.  Material and Methods:  This is a  post hoc  analysis of a multicenter randomized clinical trial in the United States. Four doses of TX-001HR, an oral combination of E2 and progesterone (P4), and placebo were tested. This analysis included a total of 1,216 early and 297 late postmenopausal women. Linear mixed-effects models tested the association of E2 dose and serum E2 levels with changes in metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels from six visits over 12 months, adjusted for the serum P4 level.  Results:  A higher E2 dose was significantly associated with lower TC ( p  = 0.02) and LDL-C ( p  = 0.002) and higher HDL-C ( p  = 0.04) levels in early, but not late, postmenopause. With longer time since menopause, the inverse association of E2 dose with TC and LDL-C and positive association with HDL-C were attenuated (interaction  p  < 0.05). Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  Conclusion:  E2 dose differentially affects metabolic measures among early compared with late postmenopausal women. No significant main effect of the serum P4 level was found. As the metabolic parameters studied are risk factors for cardiovascular events, these results support the timing hypothesis of E2 therapy and its cardiovascular benefits.",2020,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  ","['early (<6 years) compared with late (≥10 years', 'Early and Late Postmenopausal Women', 'postmenopausal women', 'late postmenopausal women', '1,216 early and 297 late postmenopausal women']","['Estradiol Dose and Serum Estradiol Levels', 'TX-001HR, an oral combination of E2 and progesterone (P4), and placebo']","['fasting blood GLUC', 'serum P4 level', 'association of estradiol (E2) dose and serum E2 levels with metabolic measures', 'LDL-C', 'Higher serum E2 levels', 'metabolic measures', 'metabolic parameters; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and glucose (GLUC) levels']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",1216.0,0.0619169,"Higher serum E2 levels were significantly associated with lower TC ( p  = 0.004), LDL-C ( p  = 0.0001), and fasting blood GLUC ( p  = 0.003) and higher TG ( p  = 0.002) levels in early postmenopause.  ","[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, Florida, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8238']
2405,32644883,"Noradrenergic Regulation of Cognitive Flexibility: No Effects of Stress, Transcutaneous Vagus Nerve Stimulation, and Atomoxetine on Task-switching in Humans.","Cognitive flexibility allows us to adaptively switch between different responsibilities in important domains of our daily life. Previous work has elucidated the neurochemical basis underlying the ability to switch responses to a previously nonreinforced exemplar and to switch between attentional sets. However, the role of neuromodulators in task switching, the ability to rapidly switch between two or more cognitive tasks afforded by the same stimuli, is still poorly understood. We attempted to fill this gap by manipulating norepinephrine levels using stress manipulation (Study 1a,  n  = 48; between-group design), transcutaneous vagus nerve stimulation at two different intensities (Study 1b,  n  = 48; sham-controlled between-group design), and pharmacological manipulation (Study 2,  n  = 24; double-blind crossover design), all of which increased salivary cortisol measures. Participants repeatedly switched between two cognitive tasks (classifying a digit as high/low [Task 1] or as odd/even [Task 2]), depending on the preceding cue. On each trial, a cue indicated the task to be performed. The cue-stimulus interval was varied to manipulate the time to prepare for the switch. Participants showed typical switch costs, which decreased with the time available for preparation. None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons. Task-switching performance reflects a complex mix of cognitive control and bottom-up dynamics of task-set representations. Our findings suggest that norepinephrine does not affect either of these aspects of cognitive flexibility.",2020,"None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons.",['Humans'],"['Stress, Transcutaneous Vagus Nerve Stimulation, and Atomoxetine', 'norepinephrine', 'transcutaneous vagus nerve stimulation at two different intensities (Study 1b,  n  = 48; sham-controlled between-group design), and pharmacological manipulation']","['typical switch costs', 'Noradrenergic Regulation of Cognitive Flexibility', 'salivary cortisol measures']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",48.0,0.019378,"None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons.","[{'ForeName': 'Klodiana-Daphne', 'Initials': 'KD', 'LastName': 'Tona', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Revers', 'Affiliation': 'Tilburg University.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Verkuil', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Leiden University.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01603']
2406,32644890,Reduction in Bacterial Loading using Papacarie and Carisolv as an Irrigant in Pulpectomized Primary Molars - A Preliminary Report.,"Objective:  The aim of the present study was to evaluate the reduction in bacterial loading using Papacarie and Carisolv as an irrigating solution in pulpectomized primary molars.  Study design:  A controlled, randomized clinical trial involving 120 necrotic canals from both genders between 3 and 7 years old children were included, 30 irrigated with Papacarie [ group I], Carisolv [ group II], 1% NaOCl gel [ group III] and 1% Na0Cl solution [group IV ] each; in all cases, 2 microbiological samples from within the canals were taken with sterile paper points, the first after the canal opening and before the first irrigation, and the second after instrumentation and final irrigation, before obturation. All samples were evaluated by Agar plate method.  Results:  The results were statistically analyzed by ANOVA. After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  Conclusion:  Papacarie and Carisolv can be suggested as an alternative irrigant for pulpectomy of necrotic teeth.",2020,"After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  ","['pulpectomized primary molars', '120 necrotic canals from both genders between 3 and 7 years old children']","['Papacarie [ group I], Carisolv [ group II], 1% NaOCl gel [ group III] and 1% Na0Cl solution']",['bacterial load'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1703313', 'cui_str': 'Papacarie'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C2936404', 'cui_str': 'Bacterial Load'}]",120.0,0.0243677,"After analyzing samples before and after irrigation in all the groups, a strong significant decrease in bacterial load [ p = < 0.001 ] was found with Papacarie and Carisolv.  ","[{'ForeName': 'Viral P', 'Initials': 'VP', 'LastName': 'Maru', 'Affiliation': ''}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Padawe', 'Affiliation': ''}, {'ForeName': 'Vandana Pandey', 'Initials': 'VP', 'LastName': 'Tripathi', 'Affiliation': ''}, {'ForeName': 'Vilas', 'Initials': 'V', 'LastName': 'Takate', 'Affiliation': ''}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Dighe', 'Affiliation': ''}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Vishwanath Dalvi', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.3.7']
2407,32644894,Efficacy of GC Gold Label 9 and GC Miracle Mix ®  Restorations using Atraumatic Restorative Treatment (ART) in Rural Settings: A Randomized Controlled Trial.,"Objectives:  This study compared the longevity of high strength posterior glass ionomer and metal-reinforced glass ionomer using ART in rural settings within an 18-month observation period.  Study Design:  A nonblinded parallel design randomized controlled trial was conducted among children who attended dental outreach programs in a rural area of Southern India. Atraumatic Restorative Treatment (ART) was performed in 92 permanent posterior teeth with either high strength posterior glass ionomer or metal-reinforced glass ionomer restorations. The allocation ratio was 1:1. Restorations were evaluated at 1, 6, 12 and 18 months after placement.  Results:  The success rate of metal-reinforced glass ionomer restorations was 100%, 95.4%, 90.4% and 87.2% as compared to high strength posterior glass ionomer whose success rates were 100%, 93%, 85% and 61.8% at the four follow ups respectively. There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015). Conclusions : Although the clinical performance of both materials were largely similar, the metal-reinforced glass ionomer restorations had a higher success rate than the conventional GIC at the end of 18 months of follow-up.",2020,There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015).,"['92 permanent posterior teeth with either high strength posterior glass ionomer or metal-reinforced glass ionomer restorations', 'Rural Settings', 'children who attended dental outreach programs in a rural area of Southern India', 'rural settings within an 18-month observation period']",['Atraumatic Restorative Treatment (ART'],"['success rates', 'success rate of metal-reinforced glass ionomer restorations', 'success rate']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",92.0,0.167449,There was a statistically significant difference between the success rate of the two materials at the end of 18 months with the metal-reinforced glass ionomer restorations having a higher success rate (p=0.015).,"[{'ForeName': 'Valerie Gloria', 'Initials': 'VG', 'LastName': ""D'Costa"", 'Affiliation': ''}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Singhal', 'Affiliation': ''}, {'ForeName': 'Shashidhar', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.3.3']
2408,32644939,Combined effects of acute exercise and hypoxia on memory.,"No previous studies have evaluated the potential combined effects of acute exercise and acute hypoxia exposure on memory function, which was the purpose of this study. Twenty-five participants (Mage = 21.2 years) completed two laboratory visits in a counterbalanced order, involving 1) acute exercise (a 20-min bout of moderate-intensity exercise) and then 30 min of exposure to hypoxia (FIO2 = 0.12), and 2) exposure to hypoxia alone (FIO2 = 0.12) for 30 min. Following this, participants completed a cued-recall and memory interference task (AB/AC paradigm), assessing cued-recall memory (recall 1 and recall 2) and memory interference (proactive and retroactive interference). For cued-recall memory, we observed a significant main effect for condition, with Exercise + Hypoxia condition having significantly greater cued-recall performance than Hypoxia alone. Memory interference did not differ as a function of the experimental condition. This experiment demonstrates that engaging in an acute bout of exercise prior to acute hypoxia exposure had an additive effect in enhancing cued-recall memory performance.",2020,Memory interference did not differ as a function of the experimental condition.,"['Twenty-five participants (Mage = 21.2 years) completed two laboratory visits in a counterbalanced order, involving 1']","['acute exercise and hypoxia', 'acute exercise (a 20-min bout of moderate-intensity exercise) and then 30 min of exposure to hypoxia (FIO2 = 0.12), and 2) exposure to hypoxia alone']","['enhancing cued-recall memory performance', 'cued-recall and memory interference task (AB/AC paradigm), assessing cued-recall memory (recall 1 and recall 2) and memory interference (proactive and retroactive interference', 'cued-recall performance', 'Memory interference']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C4517426', 'cui_str': '0.12'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",25.0,0.0371757,Memory interference did not differ as a function of the experimental condition.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': '1Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Brizes', 'Affiliation': '1Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wages', 'Affiliation': '1Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ponce', 'Affiliation': '1Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': '2Health and Sport Analytics Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Loprinzi', 'Affiliation': '1Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, The University of Mississippi, University, MS 38677, USA.'}]",Physiology international,['10.1556/2060.2020.00017']
2409,32640131,A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.,"BACKGROUND


Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.
METHODS


We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.
RESULTS


The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.
CONCLUSIONS


A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).",2020,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"['participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women', '86 primary care practices across 10 health care systems', 'older adults', 'participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries']","['multifactorial intervention', 'intervention or to enhanced usual care (the control']","['time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data', 'rate of a first adjudicated serious fall injury', 'rate of a first participant-reported fall injury', 'rates of hospitalization or death']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085639', 'cui_str': 'Falls'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2802.0,0.136147,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"[{'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McMahon', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Gazarian', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goehring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fagan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Wiggins', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Ko', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Siu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Wu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rich', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Waring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Carri', 'Initials': 'C', 'LastName': 'Casteel', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Resnick', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Haseena', 'Initials': 'H', 'LastName': 'Rajeevan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Allore', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Brooke F', 'Initials': 'BF', 'LastName': 'Brawley', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rich', 'Initials': 'R', 'LastName': 'Eder', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Boult', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rosaly', 'Initials': 'R', 'LastName': 'Correa-de-Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2002183']
2410,32640196,Impact of a multimodal telemonitoring intervention on CPAP adherence in symptomatic low-cardiovascular risk sleep apnea: a randomized controlled trial.,"BACKGROUND


One of the major challenges in treating obstructive sleep apnea (OSA) is to achieve adequate continuous positive airway pressure (CPAP) adherence. Telemonitoring has the potential to provide individualized management and early recognition of problems during treatment.
RESEARCH QUESTION


What is the effect of a multimodal telemonitoring intervention on treatment adherence, quality of life and functional status in symptomatic OSA patients with low cardiovascular risk?
STUDY DESIGN


and Methods: In a multicenter, randomized controlled trial, newly diagnosed OSA patients were randomly assigned to multimodal telemonitoring for 6 months versus usual care (UC). Telemonitoring consisted of built-in electronic alert algorithms for early adjustment of CPAP treatment in case of side effects, leaks or persistent residual events. The primary outcome was CPAP adherence (in hours/night). Secondary outcomes included daily symptoms such as fatigue and sleepiness, and quality of life measured by self-reported questionnaires.
RESULTS


Of 206 OSA patients aged 50.6 [42.1 ; 58.1] (median [IQR]) years; predominantly male (63%) with body mass index of 30.6 [26.8 ; 35.1] kg/m 2  and an apnea-hypopnea index of 45.2 [34.0 ; 60.0] events/hour) 102 received UC and 104 telemonitoring. After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 hours/night in the TM group and 5.08 ± 2.44 hours/night in the UC group, p = 0.30) or in % of patients adherent to treatment (over 4 hours usage/night, > 70% nights; 64% in TM versus 72% in UC, p = 0.24). There was no significant difference between the groups in effect size of improvement in fatigue and sleepiness.
INTERPRETATION


In severe OSA patients with low cardiovascular risk, multimodal telemonitoring did not increase CPAP adherence. For both telemonitoring and usual care groups similar improvements in daytime symptoms were achieved. NCT: 01796769.",2020,"After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 hours/night in the TM group and 5.08 ± 2.44 hours/night in the UC group, p = 0.30) or in % of patients adherent to treatment (over 4 hours usage/night, > 70% nights; 64% in TM versus 72% in UC, p = 0.24).","['obstructive sleep apnea (OSA', 'and Methods', '206 OSA patients aged 50.6 [42.1 ; 58.1] (median [IQR]) years; predominantly male (63%) with body mass index of 30.6 [26.8 ; 35.1] kg/m 2  and an apnea-hypopnea index of 45.2 [34.0 ; 60.0] events/hour) 102 received UC and 104 telemonitoring', 'newly diagnosed OSA patients', 'symptomatic OSA patients with low cardiovascular risk', 'symptomatic low-cardiovascular risk sleep apnea', 'severe OSA patients with low cardiovascular risk']","['NCT', 'multimodal telemonitoring for 6 months versus usual care (UC', 'multimodal telemonitoring intervention']","['treatment adherence, quality of life and functional status', 'daily symptoms such as fatigue and sleepiness, and quality of life measured by self-reported questionnaires', 'fatigue and sleepiness', 'daytime symptoms', 'mean duration of usage', 'CPAP adherence', 'CPAP adherence (in hours/night']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.136478,"After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 hours/night in the TM group and 5.08 ± 2.44 hours/night in the UC group, p = 0.30) or in % of patients adherent to treatment (over 4 hours usage/night, > 70% nights; 64% in TM versus 72% in UC, p = 0.24).","[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France. Electronic address: rtamisier@chu-grenoble.fr.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Treptow', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Joyeux-Faure', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Levy', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sapene', 'Affiliation': 'Private practice sleep and respiratory disease center, Nouvelle Clinique Bel Air, Bordeaux, France.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Benmerad', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bailly', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Grillet', 'Affiliation': 'Private practice sleep and respiratory disease center, Valence, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Stach', 'Affiliation': 'Private practice sleep and respiratory disease center, Valenciennes, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Muir', 'Affiliation': 'Rouen University Hospital, Bois Guillaume, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Pegliasco', 'Affiliation': 'Private practice sleep and respiratory disease center, Marseille, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.05.613']
2411,32640286,Deconstructing the effects of concentration meditation practice on interference control: The roles of controlled attention and inflammatory activity.,"Prior work has linked meditation practice to improvements in interference control. However, the mechanisms underlying these improvements are relatively unknown. In the context of meditation training, improvements in interference control could result eitherfrom increases in controlled attention to goal-relevant stimuli, or from reductions in automatic capture by goal-irrelevant stimuli. Moreover, few studies have linked training-related changes in attention to physiological processes, such as inflammatory activity, that are thought to influence cognitive function. This study addresses these gaps by examining associations between cognitive performance and cytokines in the context of an intensive meditation retreat. Participants were randomly assigned to complete 3 months of meditation training first, or to serve as waiting-list controls. The waitlist control participants then later completed a separate 3-month training intervention. We assessed participants' interference control with a flanker task and used computational modeling to derive component processes of controlled and automatic attention. We also collected blood samples at the beginning, middle, and end of training to quantify changes in cytokine activity. Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat. Importantly, inflammatory activity was inversely associated with controlled attention during both interventions. Our results suggest that practice of concentration meditation influences interference control by enhancing controlled attention to goal-relevant task elements, and that inflammatory activity relates to individual differences in controlled attention.",2020,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.",[],"['concentration meditation practice', 'concentration meditation', 'meditation training', 'meditation training first, or to serve as waiting-list controls']","['inflammatory activity', 'interference control']",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0134664,"Participants who completed training evidenced better controlled attention than waitlist controls during the first retreat intervention, and controls showed significant improvements in controlled attention when they completed their own, second retreat.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA. Electronic address: gshields@uark.edu.'}, {'ForeName': 'Alea C', 'Initials': 'AC', 'LastName': 'Skwara', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA; Department of Psychology, University of California, Davis, CA, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'King', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Zanesco', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Firdaus S', 'Initials': 'FS', 'LastName': 'Dhabhar', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences and The Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Clifford D', 'Initials': 'CD', 'LastName': 'Saron', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, CA, USA. Electronic address: cdsaron@ucdavis.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.034']
2412,32645111,The effects of ten weeks resistance training on sticking region in chest-press exercises.,"The aim of the study was to compare the effects of a 10-week chest-press resistance training on lifting regions in a trained exercise and a none-trained exercise; the barbell bench press (BBP). Thirty-five resistance trained men with 4.2 (± 2.3) years of resistance training experience were recruited. The participants were randomized to attend a resistance program, performing the chest-press, twice per week using either, Smith machine, dumbbells or laying on Swiss ball using a barbell. A six-repetitions maximum (6RM) test was conducted pre- and post-training in the trained chest-press exercise and non-trained BBP to examine lifting velocity, load displacement and the time of the pre-sticking, sticking and post-sticking regions. Additionally, the muscle activity in pectoralis major, triceps brachii, biceps brachii and deltoid anterior was examined. In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region. Independent of the type of chest-press exercise trained, no differences were observed in vertical displacement or in the muscle activity for the three lifting regions. In general, similar changes in kinematics in trained exercise and those observed in the BBP were observed for all three groups. This indicates that none of the three chest-press exercises (Swiss ball, Smith machine or dumbbells) were specific regarding the lifting regions but displaced a transferability towards the non-trained BBP. However, improved strength altered the sticking region among resistance trained men.",2020,"In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region.",['Thirty-five resistance trained men with 4.2 (± 2.3) years of resistance training experience were recruited'],"['10-week chest-press resistance training', 'Smith machine, dumbbells or laying on Swiss ball using a barbell', 'resistance training']","['lifting velocity', 'muscle activity in pectoralis major, triceps brachii, biceps brachii and deltoid anterior', 'BBP']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C2721273', 'cui_str': 'Balance ball exerciser'}]","[{'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}]",35.0,0.0227159,"In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region.","[{'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Rennes School of Sports, Rennes, France.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Matthew Peter', 'Initials': 'MP', 'LastName': 'Shaw', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Tom Erik Jorung', 'Initials': 'TEJ', 'LastName': 'Solstad', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}]",PloS one,['10.1371/journal.pone.0235555']
2413,32645143,Smell-based memory training: Evidence of olfactory learning and transfer to the visual domain.,"Human and non-human animal research converge to suggest that the sense of smell, olfaction, has a high level of plasticity and is intimately associated with visual-spatial orientation and memory encoding networks. We investigated whether olfactory memory training would lead to transfer to an untrained visual memory task, as well as untrained olfactory tasks. We devised a memory intervention to compare transfer effects generated by olfactory and non-olfactory (visual) memory training. Adult participants were randomly assigned to daily memory training for about 40 days with either olfactory or visual tasks, that had a similar difficulty level. Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task. Olfactory training also improved participants' performance on odor discrimination and naming tasks, such that they reached the same performance level as a high-performing group of wine professionals. Our results indicate that the olfactory system is highly responsive to training, and we speculate that the sense of smell may facilitate transfer of learning to other sensory domains. Further research is however needed in order to replicate and extend our findings.",2020,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.",['Adult participants'],"['olfactory memory training', 'olfactory and non-olfactory (visual) memory training', 'Smell-based memory training', 'Olfactory training', 'daily memory training']","['olfactory memory task, olfactory training produced transfer to the untrained visual memory task', ""participants' performance on odor discrimination and naming tasks""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0220731,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.","[{'ForeName': 'Jonas K', 'Initials': 'JK', 'LastName': 'Olofsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ekström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Elmeri', 'Initials': 'E', 'LastName': 'Syrjänen', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jonsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Chemical senses,['10.1093/chemse/bjaa049']
2414,32645144,"Risk Factors for Healthcare Personnel Infection with Endemic Coronaviruses (HKU1, OC43, NL63, 229E): Results from the Respiratory Protection Effectiveness Clinical Trial (ResPECT).","BACKGROUND


SARS-CoV-2 presents a large risk to healthcare personnel. Quantifying the risk of coronavirus infection associated with workplace activities is an urgent need.
METHODS


We assessed the association of worker characteristics, occupational roles and behaviors, and participation in procedures with the risk of endemic coronavirus infection among healthcare personnel who participated in the Respiratory Protection Effectiveness Trial (ResPECT), a cluster randomized trial to assess personal protective equipment to prevent respiratory infections and illness conducted from 2011 to 2016.
RESULTS


Among 4,689 HCP-seasons, we detected coronavirus infection in 387 (8%). HCP who participated in an aerosol generation procedure (AGP) at least once during the viral respiratory season were 105% (95% CI 21%, 240%) more likely to be diagnosed with a laboratory-confirmed coronavirus infection. Younger individuals, those who saw pediatric patients and those with household members under the age of five were at increased risk of coronavirus infection.
CONCLUSIONS


Our analysis suggests the risk of HCP becoming infected with an endemic coronavirus increases approximately two-fold with exposures to AGP. Our findings may be relevant to the Coronavirus Disease 2019 (COVID-19) pandemic; however, SARS-COV-2, the virus that causes COVID-19, may differ from endemic coronaviruses in important ways.",2020,"Younger individuals, those who saw pediatric patients and those with household members under the age of five were at increased risk of coronavirus infection.
","['respiratory infections and illness conducted from 2011 to 2016', '4,689 HCP-seasons', 'Younger individuals, those who saw pediatric patients and those with household members']",['personal protective equipment'],['risk of coronavirus infection'],"[{'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}]",,0.216911,"Younger individuals, those who saw pediatric patients and those with household members under the age of five were at increased risk of coronavirus infection.
","[{'ForeName': 'Derek A T', 'Initials': 'DAT', 'LastName': 'Cummings', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Radonovich', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Morgantown, WV, USA.'}, {'ForeName': 'Geoffrey J', 'Initials': 'GJ', 'LastName': 'Gorse', 'Affiliation': 'Veterans Affairs St. Louis Health Care System, St. Louis, MO, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Bessesen', 'Affiliation': 'Veterans Affairs Eastern Colorado Healthcare System, Denver, CO, USA.'}, {'ForeName': 'Alexandria C', 'Initials': 'AC', 'LastName': 'Brown', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Matthew D T', 'Initials': 'MDT', 'LastName': 'Hitchings', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lessler', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Nyquist', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rattigan', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.'}, {'ForeName': 'Connie Savor', 'Initials': 'CS', 'LastName': 'Price', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Reich', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'Veterans Affairs New York Harbor Healthcare System, New York, NY, USA.'}, {'ForeName': 'Trish M', 'Initials': 'TM', 'LastName': 'Perl', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa900']
2415,32645158,Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial.,"BACKGROUND


People with human immunodeficiency virus (PWH) face increased risks for heart failure and adverse heart failure outcomes. Myocardial steatosis predisposes to diastolic dysfunction, a heart failure precursor. We aimed to characterize myocardial steatosis and associated potential risk factors among a subset of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) participants.
METHODS


Eighty-two PWH without known heart failure successfully underwent cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content (a continuous marker for myocardial steatosis extent). Logistic regression models were applied to investigate associations between select clinical characteristics and odds of increased or markedly increased IMTG content.
RESULTS


Median (Q1, Q3) IMTG content was 0.59% (0.28%, 1.15%). IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants. Parameters associated with increased IMTG content included age (P = .013), body mass index (BMI) ≥ 25 kg/m2 (P = .055), history of intravenous drug use (IVDU) (P = .033), and nadir CD4 count < 350 cells/mm³ (P = .055). Age and BMI ≥ 25 kg/m2 were additionally associated with increased odds of markedly increased IMTG content (P = .049 and P = .046, respectively).
CONCLUSIONS


A substantial proportion of antiretroviral therapy-treated PWH exhibited myocardial steatosis. Age, BMI ≥ 25 kg/m2, low nadir CD4 count, and history of IVDU emerged as possible risk factors for myocardial steatosis in this group.
CLINICAL TRIALS REGISTRATION


NCT02344290; NCT03238755.",2020,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"['Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial', '25 kg/m2 ', 'HIV (REPRIEVE) participants', 'People with human immunodeficiency virus (PWH', 'Eighty-two PWH without known heart failure successfully underwent']","['cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content', 'Antiretroviral Therapy']","['Median (Q1, Q3', 'Age and BMI ≥', 'myocardial steatosis', 'body mass index (BMI) ≥', 'Myocardial Steatosis', 'IMTG content', 'nadir CD4 count', 'history of intravenous drug use (IVDU']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user'}]",,0.0838812,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"[{'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kim-Lien', 'Initials': 'KL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Vlad G', 'Initials': 'VG', 'LastName': 'Zaha', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Kara W', 'Initials': 'KW', 'LastName': 'Chew', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Leavitt', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ntobeko A B', 'Initials': 'NAB', 'LastName': 'Ntusi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Magid', 'Initials': 'M', 'LastName': 'Awadalla', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Nelson', 'Affiliation': 'Applied Physiology and Advanced Imaging Laboratory, Department of Kinesiology, University of Texas at Arlington, Arlington, Texas, USA.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Clinical Research Unit, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Skiest', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Tashima', 'Affiliation': 'Division of Infectious Diseases, The Miriam Hospital and Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Center for Clinical AIDS Research and Education, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-University of California, Los Angeles Medical Center and David Geffen School of Medicine at the University of Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Alysse G', 'Initials': 'AG', 'LastName': 'Wurcel', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Bolan', 'Affiliation': 'Los Angeles Lesbian Gay Bisexual Transgender Center, Los Angeles, California, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke Clinical Research Institute, Duke Global Health Institute, Department of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Division of Pulmonology and Department of Medicine, University of Cape Town Lung Institute, Mowbray, Cape Town, South Africa.'}, {'ForeName': 'Matthew Bidwell', 'Initials': 'MB', 'LastName': 'Goetz', 'Affiliation': 'Infectious Diseases Section, Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Alberta', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Lidia S', 'Initials': 'LS', 'LastName': 'Szczepaniak', 'Affiliation': 'Biomedical Research Consulting in Magnetic Resonance Spectroscopy, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa245']
2416,32645161,Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators.,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus. Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents, REPRIEVE will assess the effects of a statin as a cardiovascular disease prevention strategy in people with HIV (PWH) receiving antiretroviral therapy (ART). Although the primary purpose of REPRIEVE, and its substudy assessing coronary plaque, is to assess cardiovascular outcomes, the trial is a rich source of data on population characteristics and critical comorbidities in PWH, particularly across Global Burden of Disease (GBD) regions, reflective of the ethnic, racial, and gender diversity in this global epidemic. The purpose of this Supplement is to leverage the rich phenotyping in REPRIEVE, to provide data on detailed patterns of baseline ART and immune function by GBD region, reproductive aging among cisgender women, and data on the participation and clinical characteristics of transgender participants. We also leveraged REPRIEVE to assess critical comorbidities, including renal dysfunction, muscle function and frailty, and myocardial steatosis. REPRIEVE is a remarkable collaboration between funders, trial networks, clinical research sites, clinical and data coordinating centers, and willing participants who devoted their time to make the trial possible.",2020,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"['Human Immunodeficiency Virus', 'human immunodeficiency virus', 'Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents', 'people with HIV (PWH) receiving antiretroviral therapy (ART']",[],"['renal dysfunction, muscle function and frailty, and myocardial steatosis']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],"[{'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",7770.0,0.113634,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Center, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa098']
2417,32645640,The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis.,"OBJECTIVE


Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.
METHODS


Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.
RESULTS


CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.
CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust.",2020,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles",[],"['placebo or interferon-beta to ocrelizumab', 'cladribine and alemtuzumab', 'Ocrelizumab', 'ocrelizumab']","['annualized relapse rate', 'new T1 gadolinium-enhancing or T2 lesions']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0255681,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom. Electronic address: david.baker@qmul.ac.uk.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Pryce', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Marta', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102279']
2418,32645683,Eye tracking of smoking-related stimuli in tobacco use disorder: A proof-of-concept study combining attention bias modification with alpha-transcranial alternating current stimulation.,"BACKGROUND


Tobacco use disorder (TUD) is characterized by the presence of an attentional bias (AB) towards smoking-related stimuli. We investigated whether combining an AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS) applied over the dorsolateral prefrontal cortex (DLPFC) reduces the AB towards smoking-related stimuli, as well as craving level and impulsive choices.
METHODS


In a sham-controlled, crossover preliminary study, 19 subjects with TUD received two stimulation arms: 1) active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM, in a randomized order, separated by one week. AB towards smoking cues during passive observation of smoking and neutral cues was assessed with an eye-tracking device and reactions times at a visual-probe task. Craving level was measured with the Questionnaire of Smoking Urges. Impulsive choices were assessed with the delay discounting task.
RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM. No significant effects were reported on other craving dimensions and on AB based on reaction times.
CONCLUSIONS


These preliminary findings suggest that combining tACS with ABM may help smokers who wish to quit by reducing the desire to smoke, attention to smoking-cues, and impulsive decision-making.",2020,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","['19 subjects with TUD received two stimulation arms: 1', 'tobacco use disorder']","['tACS with ABM', 'alpha-transcranial alternating current stimulation', 'active tACS (10 Hz, 2 mA, 30 min) combined with ABM and 2) sham tACS combined with ABM', 'AB modification paradigm (ABM) with transcranial alternating current stimulation (tACS']","['Impulsive choices', 'increase of self-reported desire to smoke', 'delay discounting task', 'proportion of impulsive choices', 'craving dimensions and on AB based on reaction times', 'Craving level', 'time spent looking at smoking-related pictures']","[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",19.0,0.0484381,"RESULTS


Active tACS combined with ABM reduced the amount of time spent looking at smoking-related pictures (p = 0.03), prevented the increase of self-reported desire to smoke (p = 0.026), and reduced the proportion of impulsive choices (p = 0.049), compared to sham tACS combined with ABM.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mondino', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lenglos', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cinti', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Renauld', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': ""Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, 2325 rue de l'Université, Quebec City, QC, G1V 0A6, Canada. Electronic address: shirley.fecteau@fmed.ulaval.ca.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108152']
2419,32645714,A randomized controlled trial to investigate safety and variability of egg excretion after repeated controlled human hookworm infection.,"BACKGROUND


Controlled human hookworm infections could significantly contribute to the development of a hookworm vaccine. However, current models are hampered by low and unstable egg output, reducing generalizability and increasing sample sizes. This study aims to investigate the safety, tolerability and egg output of repeated exposure to hookworm larvae.
METHODS


Twenty-four healthy volunteers were randomized double blind to one, two or three doses of 50 Necatoramericanus L3 larvae at 2-week intervals. Volunteers were monitored weekly and were treated with albendazole at week 20.
RESULTS


There was no association between larval dose and number or severity of adverse events. Geomean egg loads stabilized at 697, 1668 and 1914 eggs per gram feces for the 1x50L3, 2x50L3 and 3x50L3 group respectively. Bayesian statistical modelling showed that egg count variability relative to the mean was reduced with a second infectious dose, however the third dose did not increase egg load or decrease variability. We therefore suggest 2x50L3 as an improved challenge dose. Model-based simulations indicates increased frequency of stool sampling optimizes power of hypothetical vaccine trials.
DISCUSSION


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.",2020,"DISCUSSION


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.",['Twenty-four healthy volunteers'],['albendazole'],"['safety, tolerability and egg output', 'larval dose and number or severity of adverse events']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.239602,"DISCUSSION


Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events.","[{'ForeName': 'Marie-Astrid', 'Initials': 'MA', 'LastName': 'Hoogerwerf', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jan Pieter R', 'Initials': 'JPR', 'LastName': 'Koopman', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Janse', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marijke C C', 'Initials': 'MCC', 'LastName': 'Langenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'van Schuijlenburg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Yvonne C M', 'Initials': 'YCM', 'LastName': 'Kruize', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Eric A T', 'Initials': 'EAT', 'LastName': 'Brienen', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Mikhael D', 'Initials': 'MD', 'LastName': 'Manurung', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Verbeek-Menken', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Martha T', 'Initials': 'MT', 'LastName': 'van der Beek', 'Affiliation': 'Clinical Microbiology Laboratory, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Westra', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Meij', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van Lieshout', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Sake J', 'Initials': 'SJ', 'LastName': 'de Vlas', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yazdanbakhsh', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Luc E', 'Initials': 'LE', 'LastName': 'Coffeng', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa414']
2420,32645765,Efficacy of Nitric Oxide Administration During Neonatal Cardiopulmonary Bypass.,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.",2020,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.","['infants undergoing the Norwood procedure', 'Neonatal Cardiopulmonary Bypass']","['Nitric Oxide Administration', 'nitric oxide administration', 'placebo']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2242650', 'cui_str': 'Norwood procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.107972,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.","[{'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120920625']
2421,32645767,Randomized Pilot Trial of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients.,"BACKGROUND


Due to the substantial improvement in survival among pediatric patients undergoing congenital heart surgery, reducing early and long-term morbidity is becoming the major focus of care. Blood transfusion is associated with worse postoperative outcomes after cardiac surgery. Acute normovolemic hemodilution (ANH) is a blood conservation strategy that aims to reduce allogenic blood transfusion during cardiac surgery. However, there are scant data regarding its efficacy for pediatric cardiac surgery patients.
METHODS


We designed a single-center, controlled, randomized, pilot trial in patients between 6 and 36 months old undergoing pediatric heart surgery. Patients were equally assigned to undergo ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care. The primary end point was the amount of blood product transfused perioperatively. Secondary end points were markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay. The analysis was by intention-to-treat. Estimates of differences between groups are presented with 95% CIs.
RESULTS


Twelve pediatric heart surgery patients were randomized to each group, ANH and usual care. Baseline characteristics were similar between groups. Acute normovolemic hemodilution implementation did not result in a reduction in the administration of blood product transfused (difference between ANH and usual care among patients transfused = -1.4 mL [-29.4 to 26.6],  P  = .92). Secondary end points were not different between groups.
CONCLUSIONS


In this small trial of pediatric cardiac surgery patients, ANH as a strategy to reduce blood component therapy was safe; however, the study failed to show a reduction in perioperative transfusion or other postoperative outcomes.",2020,"Secondary end points were not different between groups.
","['Pediatric Cardiac Surgery Patients', 'Twelve pediatric heart surgery patients', 'pediatric cardiac surgery patients', 'pediatric patients undergoing congenital heart surgery', 'patients between 6 and 36 months old undergoing pediatric heart surgery']","['ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care', 'Acute Normovolemic Hemodilution', 'Acute normovolemic hemodilution (ANH']","['markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay', 'blood product transfused', 'amount of blood product transfused perioperatively', 'allogenic blood transfusion']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3163775', 'cui_str': 'Acute normovolemic hemodilution'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C3160876', 'cui_str': 'Allogenic blood transfusion'}]",12.0,0.15526,"Secondary end points were not different between groups.
","[{'ForeName': 'Weronika M', 'Initials': 'WM', 'LastName': 'Harris', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Miriam M', 'Initials': 'MM', 'LastName': 'Treggiari', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Giacomuzzi', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jayme J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Muralidaran', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120923627']
2422,32645890,The Effect of Different Cadence on Paddling Gross Efficiency and Economy in Stand-Up Paddle Boarding.,"Background:  Due to the importance of energy efficiency and economy in endurance performance, it is important to know the influence of different paddling cadences on these variables in the stand-up paddleboarding (SUP). The purpose of this study was to determine the effect of paddling at different cadences on the energy efficiency, economy, and physiological variables of international SUP race competitors.  Methods:  Ten male paddlers (age 28.8 ± 11.0 years; height 175.4 ± 5.1 m; body mass 74.2 ± 9.4 kg) participating in international tests carried out two test sessions. In the first one, an incremental exercise test was conducted to assess maximal oxygen uptake and peak power output (PPO). On the second day, they underwent 3 trials of 8 min each at 75% of PPO reached in the first test session. Three cadences were carried out in different trials randomly assigned between 45-55 and 65 strokes-min -1  (spm). Heart rate (HR), blood lactate, perceived sense of exertion (RPE), gross efficiency, economy, and oxygen uptake (VO 2 ) were measured in the middle (4-min) and the end (8-min) of each trial.  Results:  Economy (45.3 ± 5.7 KJ·l -1  at 45 spm vs. 38.1 ± 5.3 KJ·l -1  at 65 spm;  p  = 0.010) and gross efficiency (13.4 ± 2.3% at 45 spm vs. 11.0 ± 1.6% at 65 spm;  p  = 0.012) was higher during de 45 spm condition than 65 spm in the 8-min. Respiratory exchange ratio (RER) presented a lower value at 4-min than at 8-min in 55 spm (4-min, 0.950 ± 0.065 vs. 8-min, 0.964 ± 0.053) and 65 spm cadences (4-min, 0.951 ± 0.030 vs. 8-min, 0.992 ± 0.047;  p  < 0.05). VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min. Moreover, lactate and RPE at 65 spm was greater than 55 spm ( p  < 0.05) at 8-min.  Conclusion:  International male SUP paddlers were most efficient and economical when paddling at 45 spm vs. 55 or 65 spm, confirmed by lower RPE values, which may likely translate to faster paddling speed and greater endurance.",2020,"VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min.",['Methods:  Ten male paddlers (age 28.8 ± 11.0 years; height 175.4 ± 5.1 m; body mass 74.2 ± 9.4 kg) participating in international tests carried out two test sessions'],[],"['Respiratory exchange ratio (RER', 'lactate and RPE', 'maximal oxygen uptake and peak power output (PPO', 'Heart rate (HR), blood lactate, perceived sense of exertion (RPE), gross efficiency, economy, and oxygen uptake (VO 2 ', 'gross efficiency', 'VO 2 , HR, lactate, and RPE']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]",[],"[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",2.0,0.0798461,"VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min.","[{'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Castañeda-Babarro', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Santos-Concejero', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country UPV/EHU, 01007 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Viribay', 'Affiliation': 'Glut4Science, Physiology, Nutrition and Sport, 01004 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Gutiérrez-Santamaría', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134893']
2423,32645892,Analysis of Motor Intervention Program on the Development of Gross Motor Skills in Preschoolers.,"This study aimed to investigate the influence of a structured movement activity program on the motor development of children aged three to five years attending preschool. Participants were 136 preschool students with normative development at three to four years old who lived in the Region of Murcia (Spain). The McCarthy Children's Psychomotricity and Aptitude Scales (MSCA) battery of psychomotor tests was used to evaluate the motor development profiles of preschoolers before and after the intervention. The sample was divided into two groups: an intervention group (28 students) and a comparison group (108 students). A structured 24 week physical education program was used in the intervention group. An experiential program based on free play was used in the comparison group during the same period. Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination. Statistically significant differences in the post-intervention measurements between the comparison group and the intervention group on arm and leg coordination were observed, whereby the intervention group presented higher arm coordination values ( F 1,134  = 14,389,  p  = 0.000,  η 2  = 0.097) and higher leg coordination values ( F 1,134  = 19,281,  p  = 0.000,  η 2  = 0.126) than the comparison group. It was pointed out that structured physical activity education is better educational methodology than free play to achieve adequate motor development in preschool children.",2020,Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination.,"['Participants were 136 preschool students with normative development at three to four years old who lived in the Region of Murcia (Spain', 'children aged three to five years attending preschool', 'Preschoolers', 'preschool children']","['structured movement activity program', 'Motor Intervention Program']","[""McCarthy Children's Psychomotricity and Aptitude Scales (MSCA) battery of psychomotor tests"", 'higher arm coordination values', 'higher leg coordination values', 'leg coordination']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",136.0,0.015633,Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination.,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ruiz-Esteban', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Terry Andrés', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Méndez', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Morales', 'Affiliation': 'Department of Music, Autonomous University of Madrid, 28049 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134891']
2424,32645934,Effects of Prolonged Whey Protein Supplementation and Resistance Training on Biomarkers of Vitamin B12 Status: A 1-Year Randomized Intervention in Healthy Older Adults (the CALM Study).,"We investigated the effect of long-term whey supplementation on biomarkers of B12 status in healthy older adults subjected to different schemes of supplements and exercise. The total study population examined at baseline consisted of 167 healthy older adults (age ≥ 65 year) who were randomized to 1-y intervention with two daily supplements of (1) whey protein (3.1 µg B12/day) (WHEY-ALL), (2) collagen (1.3 µg B12/day) (COLL), or (3) maltodextrin (0.3 µg B12/day) (CARB). WHEY-ALL was comprised of three groups, who performed heavy resistance training (HRTW), light resistance training (LITW), or no training (WHEY). Dietary intake was assessed through 3-d dietary records. For the longitudinal part of the study, we included only the participants ( n  = 110), who met the criteria of ≥ 50% compliance to the nutritional intervention and ≥ 66% and ≥ 75% compliance to the heavy and light training, respectively. Fasting blood samples collected at baseline and 12 months and non-fasting samples collected at 6 and 18 months were examined for methylmalonic acid, B12 and holotranscobalamin. At baseline, the study population ( n  = 167) had an overall adequate dietary B12 intake of median (range) 5.3 (0.7-65) µg/day and median B12 biomarker values within reference intervals. The whey intervention (WHEY-ALL) caused an increase in B12 ( P  < 0.0001) and holotranscobalamin ( P  < 0.0001). In addition, methylmalonic acid decreased in the LITW group ( P  = 0.04). No change in B12 biomarkers was observed during the intervention with collagen or carbohydrate, and the training schedules induced no changes. In conclusion, longer-term daily whey intake increased plasma B12 and holotranscobalamin in older individuals. No effect of intervention with collagen or carbohydrate or different training regimes was observed. Interestingly, the biomarkers of B12 status appeared to be affected by fasting vs. non-fasting conditions during sample collection.",2020,The whey intervention (WHEY-ALL) caused an increase in B12 ( P  < 0.0001) and holotranscobalamin ( P  < 0.0001).,"['older individuals', 'healthy older adults', '167 healthy older adults (age ≥ 65 year', 'participants ( n  = 110), who met the criteria of ≥ 50% compliance to the nutritional intervention and ≥ 66% and ≥ 75% compliance to the heavy and light training, respectively', 'Healthy Older Adults (the CALM Study']","['1-y intervention with two daily supplements of (1) whey protein (3.1 µg B12/day) (WHEY-ALL), (2) collagen (1.3 µg B12/day) (COLL), or (3) maltodextrin', 'long-term whey supplementation', 'Prolonged Whey Protein Supplementation and Resistance Training', 'heavy resistance training (HRTW), light resistance training (LITW), or no training (WHEY']","['overall adequate dietary B12 intake of median (range) 5.3', 'plasma B12 and holotranscobalamin', 'Fasting blood samples', 'methylmalonic acid', 'biomarkers of B12 status', 'B12 biomarkers', 'Biomarkers of Vitamin B12 Status', 'Dietary intake', 'holotranscobalamin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",167.0,0.0236391,The whey intervention (WHEY-ALL) caused an increase in B12 ( P  < 0.0001) and holotranscobalamin ( P  < 0.0001).,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Greibe', 'Affiliation': 'Department of Clinical Medicine/Clinical Biochemistry, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Reitelseder', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Nielsine Nielsens Vej 11, DK-2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Rasmus L', 'Initials': 'RL', 'LastName': 'Bechshøft', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Nielsine Nielsens Vej 11, DK-2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bülow', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Nielsine Nielsens Vej 11, DK-2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Grith W', 'Initials': 'GW', 'LastName': 'Højfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Nielsine Nielsens Vej 11, DK-2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Schacht', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Noerre Alle 51, DK-2200 Copenhagen N, Denmark.'}, {'ForeName': 'Mads L', 'Initials': 'ML', 'LastName': 'Knudsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Noerre Alle 51, DK-2200 Copenhagen N, Denmark.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Tetens', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Noerre Alle 51, DK-2200 Copenhagen N, Denmark.'}, {'ForeName': 'Marie S', 'Initials': 'MS', 'LastName': 'Ostenfeld', 'Affiliation': 'Arla Foods Ingredients Group P/S, Soenderhoej 10-12, DK-8260 Viby J, Denmark.'}, {'ForeName': 'Ulla R', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Arla Foods Ingredients Group P/S, Soenderhoej 10-12, DK-8260 Viby J, Denmark.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Heegaard', 'Affiliation': 'Department of Molecular Biology and Genetics, Aarhus University, Gustav Wieds Vej 10, DK-8000 Aarhus, Denmark.'}, {'ForeName': 'Ebba', 'Initials': 'E', 'LastName': 'Nexo', 'Affiliation': 'Department of Clinical Medicine/Clinical Biochemistry, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holm', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Nielsine Nielsens Vej 11, DK-2400 Copenhagen NV, Denmark.'}]",Nutrients,['10.3390/nu12072015']
2425,32645968,Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School-Aged Children with Acquired Brain Injury.,"(1) Background: Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children, called Intensive Memory-Focused Training Program (IM-FTP); (2) Methods: Eleven children and adolescents with ABI (mean age at injury = 12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury = 13.8 years) were clinically assessed, and rehabilitated through a standard program; (3) Results: After treatment, both groups had marked improvement in both immediate and delayed recall. IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory. Imaging showed functional modification in the left frontal inferior cortex; (4) Conclusions: We described an age-independent reproducible multidisciplinary memory-focused rehabilitation protocol, which can be adapted to single patients while preserving inter-subject comparability, and is applicable up to a few months after injury. IM-FTP will now be employed in a powered clinical trial.",2020,"IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory.","['School-Aged Children with Acquired Brain Injury', 'Ten pediatric controls with ABI (mean age at injury = 13.8 years) were clinically assessed, and rehabilitated through a standard program; (3) Results', 'pediatric Acquired Brain Injury (ABI', 'children, called Intensive Memory-Focused Training Program (IM-FTP); (2) Methods: Eleven children and adolescents with ABI (mean age at injury = 12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments']","['IM-FTP', 'Intensive Memory-Focused Training Program']",['immediate and delayed recall'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022699', 'cui_str': 'Kinesis'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",11.0,0.0850281,"IM-FTP was associated with better learning of semantically related and unrelated words, and larger improvement in immediate recall in prose memory.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Recla', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Molteni', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, and Centre for Medical Engineering, King's College, SE1 7EU London, UK.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Manfredi', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Arrigoni', 'Affiliation': 'Neuroimaging Lab, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nordio', 'Affiliation': 'Neuroimaging Lab, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Galbiati', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Pastore', 'Affiliation': 'Neurophysiatric Department, Neuropsychological and Cognitive-behavioral Service, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Modat', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, and Centre for Medical Engineering, King's College, SE1 7EU London, UK.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Strazzer', 'Affiliation': 'Neurophysiatric Department, Scientific Institute, I.R.C.C.S. Eugenio Medea, 23842 Bosisio Parini, Italy.'}]",Brain sciences,['10.3390/brainsci10070430']
2426,32646010,Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention-A 12-Month Subanalysis of the ACOORH Trial.,"Lifestyle interventions have been shown to reverse hyperglycemia to normoglycemia. However, these effects are not long-lasting and are accompanied with high dropout rates. As formula diets have been shown to be simple in usage and effective in improving glycemic control, we hypothesised that adding a low-carbohydrate and energy deficit formula diet to a low-intensity lifestyle intervention is superior in reversing prediabetes compared with lifestyle intervention alone. In this predefined subanalysis of an international, multicenter randomised controlled trial ( Almased Concept against Overweight and Obesity and Related Health Risk  (ACOORH) study (ID DRKS00006811)), 141 persons with prediabetes were randomised (1:2) into either a control group with lifestyle intervention only (CON,  n  = 45) or a lifestyle intervention group accompanied with a formula diet (INT,  n  = 96). Both groups were equipped with telemonitoring devices. INT received a low-carbohydrate formula diet substituting three meals/day (~1200 kcal/day) within the first week, two meals/day during week 2-4, and one meal/day during week 5-26 (1300-1500 kcal/day). Follow-up was performed after 52 weeks and 105 participants (75%, INT:  n  = 74; CON:  n  = 31) finished the 26-week intervention phase. Follow-up data after 52 weeks were available from 93 participants (66%, INT:  n  = 65; CON:  n  = 28). Compared with CON, significantly more INT participants converted to normoglycemia after 52 weeks (50% vs. 31%;  p  < 0.05). The risk reduction led to a number-needed-to-treat of 5.3 for INT. Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention.",2020,Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention.,['141 persons with prediabetes'],"['Normoglycemia', 'Lifestyle interventions', 'Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention', 'Lifestyle intervention with a low-carbohydrate formula diet', 'CON', 'control group with lifestyle intervention only (CON,  n  = 45) or a lifestyle intervention group accompanied with a formula diet']",['normoglycemia'],"[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0255759,Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Düsseldorf, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Düsseldorf, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute for Sports and Sport Science, University of Frankfurt, 60487 Frankfurt, Germany.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Klaus-Michael', 'Initials': 'KM', 'LastName': 'Braumann', 'Affiliation': 'Department of Sports and Movement Medicine, Faculty of Psychology and Human Movement Sciences, University of Hamburg, 20148 Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism and Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, 45122 Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Halle', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), 80992 Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Public Health Nutrition Research Group, London Metropolitan University, London N7 8DB, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Pinget', 'Affiliation': ""Department Endocrinologie, Diabete et Maladies Métaboliques, Faculte de Medicine de'l University de Strasbourg, 67170 Strasbourg, France.""}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scholze', 'Affiliation': 'KARDIOS, Cardioligists in Berlin, 10787 Berlin, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Toplak', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Medical University of Graz, 8010 Graz, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, 40591 Düsseldorf, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Acoorh Study Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu12072022']
2427,32646037,Crying Therapy Intervention for Breast Cancer Survivors: Development and Effects.,"BACKGROUND


crying therapy is currently being applied in some countries to treat cancer patients, manage pain, and promote mental health. However, little nursing and medical research on the effects of crying therapy has been conducted in other parts of the world. This study aimed to develop a crying therapy program for breast cancer survivors and assess its effects. Interventions/method: data from 27 breast cancer survivors in South Korea were analyzed. The intervention, employing a single group, pre-post-test quasi-experimental design, was divided into three phases, and effects were verified for emotional (distress, fatigue, and mood conditions) and physiological (cortisol, immunoglobulin G, and blood pressure) variables.
RESULTS


there were significant changes in distress, mood changes, and immunoglobulin G and smaller changes in blood pressure postintervention. Fatigue and cortisol showed no significant changes.
CONCLUSIONS


this study demonstrated the effectiveness of a short-term crying therapy program that can induce positive emotional changes and physiological effects in breast cancer survivors. This intervention can improve quality of life, indicating its value as a self-care program for cancer survivors.",2020,"Fatigue and cortisol showed no significant changes.
","['Breast Cancer Survivors', 'breast cancer survivors', 'cancer survivors', '27 breast cancer survivors in South Korea']","['short-term crying therapy program', 'Crying Therapy Intervention', 'crying therapy program']","['quality of life', 'Fatigue and cortisol', 'distress, mood changes, and immunoglobulin G and smaller changes in blood pressure postintervention', 'positive emotional changes and physiological effects', 'emotional (distress, fatigue, and mood conditions) and physiological (cortisol, immunoglobulin G, and blood pressure) variables']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",27.0,0.0200838,"Fatigue and cortisol showed no significant changes.
","[{'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Byun', 'Affiliation': 'School of Nursing, Yeungnam University College, Daegu 42415, Korea.'}, {'ForeName': 'Hyenam', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing, Daegu University, Daegu 42400, Korea.'}, {'ForeName': 'Gyung-Duck', 'Initials': 'GD', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Dongyang University, Kyungpook 36040, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134911']
2428,32646041,Effects of Neuromuscular Electrical Stimulation Synchronized with Chewing Exercises on Bite Force and Masseter Muscle Thickness in Community-Dwelling Older Adults in South Korea: A Randomized Controlled Trial.,"This study is aimed at investigating the effects of synchronized neuromuscular electrical stimulation (NMES) and chewing exercises on bite force and the masseter muscle thickness in community-dwelling older adults.  Material and methods:  Forty older adults were enrolled in South Korea and randomly assigned to either an experimental or control group. The experimental group performed chewing exercises using the No-Sick Exerciser equipment synchronized with NMES applied to the bilateral masseter muscles, while the control group performed only chewing exercises. Both groups received interventions for 20 min/day, 5 days/week, for 6 weeks. Bite force was measured using the OCCLUZER device, and masseter muscle thickness was measured using a portable ultrasound.  Results:  Both groups showed a significant increase in bite force and masseter muscle thickness compared to baseline measurements ( p  < 0.05). The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  Conclusion:  This study demonstrates that NMES synchronized with chewing exercises is more efficient in increasing bite force and masseter muscle thickness than chewing exercises alone in community-dwelling older adults.",2020,The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  ,"['community-dwelling older adults', 'Community-Dwelling Older Adults in South Korea', 'Forty older adults were enrolled in South Korea']","['Neuromuscular Electrical Stimulation Synchronized with Chewing Exercises', 'NMES synchronized with chewing exercises', 'chewing exercises using the No-Sick Exerciser equipment synchronized with NMES applied to the bilateral masseter muscles, while the control group performed only chewing exercises', 'synchronized neuromuscular electrical stimulation (NMES) and chewing exercises']","['Bite force', 'Bite Force and Masseter Muscle Thickness', 'bite force and masseter muscle thickness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0589278', 'cui_str': 'Chewing exercises'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",40.0,0.0185005,The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  ,"[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, DongSeo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134902']
2429,32646062,Oral Administration of Sodium Nitrate to Metabolic Syndrome Patients Attenuates Mild Inflammatory and Oxidative Responses to Acute Exercise.,"The beneficial effects of exercise for the treatment and prevention of metabolic syndrome pathologies have been related to its anti-inflammatory and antioxidant effects. Dietary nitrate supplementation is an emerging treatment strategy to alleviate the symptoms of metabolic syndrome affections and to improve vascular function. In this double-blind crossover trial, metabolic syndrome patients performed two exercise tests for 30 min at 60-70% maximal heart rate after the intake of a placebo or a nitrate-enriched beverage. Acute exercise increased the plasma concentration of TNFα, intercellular adhesion molecule ICAM1, PGE1, PGE2 and the newly detected 16-hydroxypalmitic acid (16-HPAL) in metabolic syndrome patients. The cytokine and oxylipin production by peripheral blood mononuclear cells (PBMCs) and neutrophils could be responsible for the plasma concentrations of TNFα and IL6, but not for the plasma concentration of oxylipins nor its post-exercise increase. The intake of sodium nitrate 30 min before exercise increased the concentration of nitrate and nitrite in the oral cavity and plasma and reduced the oxygen cost of exercise. Additionally, nitrate intake prevented the enhancing effects of acute exercise on the plasma concentration of TNFα, ICAM1, PGE1, PGE2 and 16-HPAL, while reducing the capabilities of PBMCs and neutrophils to produce oxylipins.",2020,"Acute exercise increased the plasma concentration of TNFα, intercellular adhesion molecule ICAM1, PGE1, PGE2 and the newly detected 16-hydroxypalmitic acid (16-HPAL) in metabolic syndrome patients.",['Metabolic Syndrome Patients'],"['Sodium Nitrate', 'placebo or a nitrate-enriched beverage', 'Dietary nitrate supplementation']","['plasma concentration of TNFα, intercellular adhesion molecule ICAM1, PGE1, PGE2 and the newly detected 16-hydroxypalmitic acid (16-HPAL', 'plasma concentration of TNFα, ICAM1, PGE1, PGE2 and 16-HPAL, while reducing the capabilities of PBMCs and neutrophils to produce oxylipins', 'oxygen cost of exercise', 'concentration of nitrate and nitrite']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0286501', 'cui_str': '16-hydroxypalmitic acid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}]",,0.0495819,"Acute exercise increased the plasma concentration of TNFα, intercellular adhesion molecule ICAM1, PGE1, PGE2 and the newly detected 16-hydroxypalmitic acid (16-HPAL) in metabolic syndrome patients.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capó', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}, {'ForeName': 'Miguel D', 'Initials': 'MD', 'LastName': 'Ferrer', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Olek', 'Affiliation': 'Department of Athletics performance, Strength and Conditioning, Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Salaberry', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Suau', 'Affiliation': 'Sports Medicine Service, Consell Insular de Mallorca, 07010 Palma, Spain.'}, {'ForeName': 'Bartolomé', 'Initials': 'B', 'LastName': 'Marí', 'Affiliation': 'Sports Medicine Service, Consell Insular de Mallorca, 07010 Palma, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Llompart', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Department of Basic Biology and Health Sciences, University of the Balearic Islands, 07122 Palma, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pons', 'Affiliation': 'Research Group in Community Nutrition and Oxidative Stress, Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma, Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9070596']
2430,32646228,Electroacupuncture for post-stroke overactive bladder: a multi-centre pilot randomized controlled trial.,"BACKGROUND


Although acupuncture has been shown to be effective at treating overactive bladder (OAB) following stroke, to our knowledge, no randomized controlled trial (RCT) examining the effects of acupuncture on patients with post-stroke OAB has been conducted. The aim of this preliminary study was to explore the effects of electroacupuncture (EA) in the treatment of post-stroke OAB.
METHODS


This study was a multi-site randomized, assessor-blind, controlled pilot trial of patients with post-stroke OAB. In all, 34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms were randomly assigned to the treatment group or control group in a 1:1 ratio. The subjects in the treatment group were treated with six sessions of EA for 4 weeks, while the subjects in the control group received usual care. The primary outcome measure was the overactive bladder symptom scale (OABSS). Secondary outcome measures included a three day bladder diary and the stroke-specific quality-of-life scale (SSQoL).
RESULTS


EA showed a moderate effect size (ES) on the perceived severity of OAB symptoms as measured by the OABSS at week 5 (one week post-treatment, ES 0.57; p = 0.034) and week 8 (three weeks post-treatment, ES 0.60; p = 0.021), although the results did not remain statistically significant after Bonferroni correction for multiple testing. No significant differences in bladder diary parameters or SSQoL score were found. The EA treatment was well tolerated by the post-stroke subjects.
CONCLUSION


A six-session EA treatment was feasible and appeared to reduce OAB symptoms in post-stroke patients. Further fully powered trials are warranted to confirm the efficacy of EA for those with post-stroke OAB.",2020,No significant differences in bladder diary parameters or SSQoL score were found.,"['34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms', 'post-stroke overactive bladder', 'patients with post-stroke OAB']","['electroacupuncture (EA', 'acupuncture', 'Electroacupuncture', 'control group received usual care']","['tolerated', 'severity of OAB symptoms', 'bladder diary parameters or SSQoL score', 'OAB symptoms', 'overactive bladder symptom scale (OABSS', 'moderate effect size (ES', 'three day bladder diary and the stroke-specific quality-of-life scale (SSQoL']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",34.0,0.112619,No significant differences in bladder diary parameters or SSQoL score were found.,"[{'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Changde', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Shanghai TCM-integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Shanghai TCM-integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Pui', 'Initials': 'P', 'LastName': 'Yan Chan', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lo', 'Initials': 'L', 'LastName': 'Lo Yam', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Lok Lam', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kwok-Pui', 'Initials': 'KP', 'LastName': 'Leung', 'Affiliation': 'Rehabilitation Unit, Department of Medicine, Tung Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Sheung-Wai', 'Initials': 'SW', 'LastName': 'Li', 'Affiliation': 'Rehabilitation Unit, Department of Medicine, Tung Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Wai-Yin', 'Initials': 'WY', 'LastName': 'Tsang', 'Affiliation': 'Department of Geriatrics and Rehabilitative Medicine, Tung Wah Eastern Hospital, Hong Kong, China.'}, {'ForeName': 'Bacon', 'Initials': 'B', 'LastName': 'Fung-Leung Ng', 'Affiliation': 'The Chinese Medicine Department, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tat-Chi Ziea', 'Affiliation': 'The Chinese Medicine Department, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420925488']
2431,32646264,Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.,"Background Loss to follow-up (LTFU) is common in randomized controlled trials. However, its potential impact on primary outcomes from cardiovascular randomized controlled trials is not known. Methods and Results We conducted a prospective systematic review (PROSPERO: CRD42019121959) for randomized controlled trials published in 8 leading journals over 5 years from January 2014 to December 2018. Extent, reporting, and handling of LTFU data were recorded, and the proportion of a trial's primary outcome results that lose statistical significance was calculated after making plausible assumptions for the intervention and control arms. These assumptions could drive differential treatment effects between the groups considering relative event incidence between LTFU participants and those included in the primary outcome. We identified 117 randomized controlled trials of which 91 (78%) trials reported LTFU, 23 (20%) reported no LTFU, and 3 (3%) trials did not report on whether LTFU occurred. The median percentage of study participants lost to follow-up was 2% (interquartile range, 0.33%-5.3%). Only 10 trials (9%) had a low cluster of risk factors for impairment in trial quality. The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm. Conclusions Almost 1 in 6 (16%) cardiovascular randomized trials published in leading journals may have a change in the primary outcome if plausible assumptions are made about differential event rates of participants lost to follow up. There is scope for improvement arising from LTFU in randomized trials in cardiovascular medicine. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42019121959.",2020,The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm.,"['117 randomized controlled trials of which 91 (78', '8 leading journals over 5\xa0years from January 2014 to December 2018']",[' Loss to follow-up (LTFU'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],,0.329949,The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm.,"[{'ForeName': 'Lucas Chun Wah', 'Initials': 'LCW', 'LastName': 'Fong', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Glasgow Scotland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation Dalla Lana School of Public Health University of Toronto.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Department of Medicine University of Toronto Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Glasgow Scotland.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015361']
2432,32646275,A Pilot Evaluation of an Intervention to Improve Social Reactions to Sexual and Partner Violence Disclosures.,"The purpose of this study was to evaluate an intervention ( Supporting Survivors and Self  [SSS]) created to increase positive social reactions and decrease negative social reactions to sexual assault and partner violence disclosures among informal support disclosure recipients. Participants were 1,268 college students from a medium-sized New England university who completed an online baseline survey and were assigned to either the treatment or control condition. The SSS intervention trained potential informal supports on what to say and not to say to disclosure recipients. Six months after the SSS intervention, participants in both conditions completed the follow-up survey online. Although intentions to provide positive social reactions significantly increased among participants in the treatment group compared with the control group and there were marginally significant effects in the anticipated directions for alcohol-specific intended social reactions, no overall difference was observed across conditions in actual social reactions provided. Moderation analyses suggested that, in general, the SSS intervention was more effective on various outcomes for students who were younger, male, non-White, sexual minorities, and/or non-victims. Moderation analyses also suggested that the intervention varied in efficacy depending on the circumstances of the disclosure. Despite the mixed outcomes of the SSS intervention, these data suggest that the SSS intervention was effective in improving social reactions for some students and under some circumstances. Future research is needed to further refine the SSS intervention to bolster its effectiveness in reducing negative social reactions and increasing positive social reactions for all students.",2020,"Although intentions to provide positive social reactions significantly increased among participants in the treatment group compared with the control group and there were marginally significant effects in the anticipated directions for alcohol-specific intended social reactions, no overall difference was observed across conditions in actual social reactions provided.","['informal support disclosure recipients', 'students who were younger, male, non-White, sexual minorities, and/or non-victims', 'Participants were 1,268 college students from a medium-sized New England university who completed an online baseline survey']","['SSS intervention', 'intervention ( Supporting Survivors and Self  [SSS']","['social reactions', 'positive social reactions', 'Social Reactions to Sexual and Partner Violence Disclosures']","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",1268.0,0.0189298,"Although intentions to provide positive social reactions significantly increased among participants in the treatment group compared with the control group and there were marginally significant effects in the anticipated directions for alcohol-specific intended social reactions, no overall difference was observed across conditions in actual social reactions provided.","[{'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Waterman', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Ullman', 'Affiliation': 'University of Illinois at Chicago, USA.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dardis', 'Affiliation': 'Towson University, MD, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Dworkin', 'Affiliation': 'University of Washington, Seattle, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520934437']
2433,32641097,The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial.,"BACKGROUND


The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma.
METHODS


Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment.
RESULTS


Data were collected between May 2012 and August 2016, during which time 71 sites were activated-a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation (r = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs.
CONCLUSIONS


Central collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites' available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
TRIAL REGISTRATION


ISRCTN98387754 . Registered on 31 January 2012.",2020,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
","['A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation', 'A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received', '54/191 trial participants (28%) enrolled during this period were not reported on logs', 'upper tract urothelial carcinoma', 'Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC']",['chemotherapy'],"['approach rate', 'acceptance rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",1138.0,0.424434,"No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK. Rebecca.Lewis@icr.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04559-w']
2434,32641101,"Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.","BACKGROUND


Autoimmune encephalitis is a new spectrum of autoimmune disorders of the central nervous system (CNS), which are characterized by pathogenic autoantibodies against neuronal surface antigens. Clinical presentations range from acute to subacute encephalopathy with neurological and psychiatric symptoms, and life-threatening autonomic dysfunction in severe cases. There exist no approved therapies nor is data available from controlled clinical trials. Patients are usually treated with diverse combinations of immunotherapy. However, effect of immunotherapy on antibody-producing cells and thus on levels of pathogenic autoantibodies is insufficient. Therefore, therapeutic response is sometimes prolonged with necessity of long-time intensive care treatment and also irreversible deficits occur in severe cases. This trial will investigate the efficacy and safety of bortezomib, a proteasome inhibitor known to selectively deplete plasma cells, in patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response.
METHODS


Generate-Boost is an investigator-initiated, multicenter, double-blinded, randomized controlled phase II trial which will be conducted in specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany. Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3), autoantibodies against neuronal surface antigens, and pretreatment with rituximab are eligible for study participation. Fifty patients will be randomized 1:1 and undergo up to 3 cycles (each 21 days with 4 s. c. applications) of bortezomib or placebo. All patients will receive concomitant medication with dexamethasone, acyclovir and co-trimoxazole. The primary efficacy endpoint is the mRS score 17 weeks after first treatment application. Secondary endpoints are neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores throughout the trial up to week 17. General and bortezomib-specific adverse events are monitored continuously.
DISCUSSION


The expected outcome of the study is to obtain first reliable data on a hypothesis-driven therapeutic option in severe and difficult-to-treat autoimmune encephalitis. If treatment with bortezomib is beneficial in these cases, this will be the basis for implementation in the current guidelines.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03993262 . Registered June 20, 2019; German Clinical Trials Register, DRKS00017497.",2020,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","['specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany', 'Fifty patients', 'patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response', 'Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS\u2009≥\u20093', 'patients with severe autoimmune encephalitis']","['dexamethasone, acyclovir and co-trimoxazole', 'bortezomib', 'bortezomib or placebo', 'immunotherapy']","['neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores', 'efficacy and safety', 'mRS score']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0393639', 'cui_str': 'Autoimmune encephalitis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.263428,"Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3)","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wickel', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Ha-Yeun', 'Initials': 'HY', 'LastName': 'Chung', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Platzer', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Prüss', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE) Berlin and Department of Neurology and Experimental Neurology, Charité - Universitätsmedizin Berlin, 10117, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leypoldt', 'Affiliation': 'Neuroimmunology, Institute of Clinical chemistry and Department of Neurology, University Hospital Schleswig-Holstein and Christian-Albrechts-University, Kiel, 24105, Kiel, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Günther', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Scherag', 'Affiliation': 'Center of Clinical Studies, Jena University Hospital, Jena, 07747, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geis', 'Affiliation': 'Section of Translational Neuroimmunology, Hans Berger Department of Neurology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. Christian.Geis@med.uni-jena.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04516-7']
2435,32641110,Clinical efficacy and safety in patients treated with teicoplanin with a target trough concentration of 20 μg/mL using a regimen of 12 mg/kg for five doses within the initial 3 days.,"BACKGROUND


A trough concentration (C min ) ≥20 μg/mL of teicoplanin is recommended for the treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. However, sufficient clinical evidence to support the efficacy of this target C min  has not been obtained. Even though the recommended high C min  of teicoplanin was associated with better clinical outcome, reaching the target concentration is challenging.
METHODS


Pharmacokinetics and adverse events were evaluated in all eligible patients. For clinical efficacy, patients who had bacteremia/complicated MRSA infections were analyzed. The primary endpoint for clinical efficacy was an early clinical response at 72-96 h after the start of therapy. Five dosed of 12 mg/kg or 10 mg/kg was administered as an enhanced or conventional high loading dose regimen, respectively. The C min  was obtained at 72 h after the first dose.
RESULTS


Overall, 512 patients were eligible, and 76 patients were analyzed for treatment efficacy. The proportion of patients achieving the target C min  range (20-40 μg/mL) by the enhanced regimen was significantly higher than for the conventional regimen (75.2% versus 41.0%, p < 0.001). In multivariate analysis, C min  ≥ 20 μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25-12.53). There was no significant difference in the occurrence of adverse events between patients who did or did not achieve a C min  ≥ 20 μg/mL.
CONCLUSION


A target C min  ≥ 20 μg/mL might improve early clinical responses during the treatment of difficult MRSA infections using 12 mg/kg teicoplanin for five doses within the initial 3 days.",2020,"μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25-12.53).","['patients who had bacteremia/complicated MRSA infections', 'patients treated with', '512 patients were eligible, and 76 patients', 'all eligible patients', '20\u2009μg']",['teicoplanin'],"['occurrence of adverse events', 'clinical efficacy', 'Clinical efficacy and safety', 'early clinical response', 'early clinical responses', 'proportion of patients achieving the target C min  range']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0145106', 'cui_str': 'Teicoplanin'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",512.0,0.128779,"μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25-12.53).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan. taka76@hyo-med.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Takesue', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ichiki', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Takai', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Toshie', 'Initials': 'T', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Infection Control and Prevention, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Naruhito', 'Initials': 'N', 'LastName': 'Otani', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pharmacy, Hyogo College of Medicine Hospital, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Ishihara', 'Affiliation': 'Department of Pharmacy, Hyogo College of Medicine Hospital, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Takubo', 'Affiliation': 'Department of Pharmacy, Hyogo College of Medicine Hospital, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ikeuchi', 'Affiliation': 'Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Uchino', 'Affiliation': 'Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Pharmacy, Hyogo College of Medicine Hospital, Nishinomiya, Hyogo, Japan.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00424-3']
2436,32641142,Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial.,"BACKGROUND


Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN.
METHODS


A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-α and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN.
DISCUSSION


This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment.
TRIAL REGISTRATION


www.ChiCTR.org.cn , identifier: ChiCTR1900025828. Registered on 10 September 2019.",2020,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","['patients with postherpetic neuralgia', 'patients with PHN']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'conventional treatment including medication therapy and invasive interventional therapy', 'extracorporeal shockwave therapy']","['pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI', 'Efficacy and safety', 'plasma levels of tumor necrosis factor-α and interleukin-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",98.0,0.0776759,"Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ruihao', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Fuguo', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China. zerodq_hx@163.com.""}, {'ForeName': 'Pingliang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Chengdu Medical College, Xindu, 610500, Sichuan, People's Republic of China. pingliangyang@163.com.""}]",Trials,['10.1186/s13063-020-04564-z']
2437,32641154,Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
TRIAL DESIGN


Randomised, parallel 3-arm (1:1:1 ratio), open-label, Phase IV platform trial of immunomodulatory therapies in patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment.
PARTICIPANTS


Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) >3 OR ≥3 if risk count includes ""Radiographic severity score >3"". A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x10 9 /L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory therapies in the opinion of the investigator and be able to be maintained on venous thromboembolism prophylaxis during the inpatient dosing period, according to local guidelines. The complete inclusion and exclusion criteria as detailed in the additional file 1 should be fulfilled. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King's College Hospital NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust.
INTERVENTION AND COMPARATOR


Each active comparator arm will be compared against standard of care (SoC). The immunomodulatory drugs were selected from a panel of licenced candidates by a drug evaluation committee, which considered potential efficacy, potential toxicity, scalability and novelty of each strategy. The initial active arms comprise baricitinib and ravulizumab. Baricitinib will be given 4 mg orally (once daily (OD)) on days 1-14 or until day of discharge. The dose will be reduced to 2 mg OD for patients aged > 75 years and those with an estimated Cockcroft Gault creatinine clearance of 30-60 ml/min. Ravulizumab will be administered intravenously once according to the licensed weight-based dosing regimen (see Additional file 1). Each active arm will be compared with standard of care alone. No comparisons will be made between active arms in this platform trial.
MAIN OUTCOMES


The primary outcome is the incidence (from baseline up to Day 14) of any one of the events (whichever comes first): death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
RANDOMISATION


Eligible patients will be randomised using a central web-based randomisation service (Sealed Envelope) in a 1:1:1 ratio, stratified by site to one of the treatment arms or SoC.
BLINDING (MASKING)


This is an open-label trial. Data analysis will not be blinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


There is no fixed sample size for this study. Serial interim analyses will be triggered by an Independent Data Monitoring Committee (IDMC), including analysis after 125 patients are recruited to each arm, 375 in total assuming 3 arms. Additional interim analyses are projected after 229 patients per arm, and potentially then after 469 per arm, but additional analyses may be triggered by the IDMC.
TRIAL STATUS


TACTIC-R Protocol version number 2.0 date May 20, 2020, recruitment began May 7, 2020 and the end trial will be the date 18 months after the last patient's last visit. The recruitment end date cannot yet be accurately predicted.
TRIAL REGISTRATION


Registered on EU Clinical Trials Register EudraCT Number: 2020-001354-22 Registered: 6 May 2020 It was registered on ClinicalTrials.gov ( NCT04390464 ) and on ISRCTN (ISRCTN11188345) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
","['Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) ', '125 patients are recruited to each arm, 375 in total assuming 3 arms', 'Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R', 'patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment', 'Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support', ""Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King's College Hospital NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust"", 'patients aged > 75 years and those with an estimated Cockcroft Gault creatinine clearance of 30-60 ml/min']","['specific immunomodulatory intervention', 'Ravulizumab']","['Radiographic severity score', 'incidence (from baseline up to Day 14) of any one of the events (whichever comes first): death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018408', 'cui_str': 'Guyana'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454854', 'cui_str': 'Gloucestershire'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4550350', 'cui_str': 'ravulizumab'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.473607,"To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).
","[{'ForeName': 'Spoorthy', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK. Spoorthy.kulkarni@addenbrookes.nhs.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Kostapanos', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Banham-Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Hernan-Sancho', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cope', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Galloway', 'Affiliation': ""King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hall', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, The Old Schools, Trinity Lane, Cambridge, CB2 1TN, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'University of Cambridge, The Old Schools, Trinity Lane, Cambridge, CB2 1TN, UK.'}]",Trials,['10.1186/s13063-020-04535-4']
2438,32641163,Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol of randomised controlled trial AZIQUINE-ICU.,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin. We hypothesise that early administration of hydroxychloroquine alone or in combination with azithromycin can prevent respiratory deterioration in patients admitted to intensive care due to rapidly progressive COVID-19 infection.
METHODS


Design: Prospective, multi-centre, double-blind, randomised, controlled trial (RCT).
PARTICIPANTS


Adult (> 18 years) within 24 h of admission to the intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria include duration symptoms of febrile disease for ≥ 1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, and pregnancy.
INTERVENTIONS


Patients will be randomised in 1:1:1 ratio to receive Hydroxychloroquine 800 mg orally in two doses followed by 400 mg daily in two doses and azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or hydroxychloroquine + placebo (HC group) or placebo + placebo (C-group) in addition to the best standard of care, which may evolve during the trial period but will not differ between groups. Primary outcome is the composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.
SECONDARY OUTCOMES


The percentage of patients who were prevented from needing intubation until day 14, ICU length of stay, and mortality (in hospital) at day 28 and 90.
DISCUSSION


Although both investigational drugs are often administered off label to patients with severe COVID-19, at present, there is no data from RCTs on their safety and efficacy. In vitro and observational trial suggests their potential to limit viral replication and the damage to lungs as the most common reason for ICU admission. Therefore, patients most likely to benefit from the treatment are those with severe but early disease. This trial is designed and powered to investigate whether the treatment in this cohort of patients leads to improved clinical patient-centred outcomes, such as mechanical ventilation-free survival.
TRIAL REGISTRATION


Clinical trials.gov: NCT04339816 (Registered on 9 April 2020, amended on 22 June 2020); Eudra CT number: 2020-001456-18 (Registered on 29 March 2020).",2020,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin.","['in hospital) at day 28 and 90', 'patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol', 'Eudra CT number: 2020-001456-18', 'Design', 'patients admitted to intensive care due to rapidly progressive COVID-19 infection', 'Adult (>\u200918\u2009years) within 24\u2009h of admission to the intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated', '9 April 2020, amended on 22 June 2020']","['Hydroxychloroquine 800\u2009mg orally in two doses followed by 400\u2009mg daily in two doses and azithromycin 500\u2009mg orally in one dose followed by 250\u2009mg in one dose for a total of 5\u2009days (HC-A group) or hydroxychloroquine + placebo (HC group) or placebo + placebo (C-group', 'azithromycin', 'Azithromycin', 'hydroxychloroquine']","['respiratory deterioration', 'needing intubation until day 14, ICU length of stay, and mortality', 'composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1126333', 'cui_str': 'Azithromycin 500 MG'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",,0.370962,"BACKGROUND


Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin.","[{'ForeName': 'František', 'Initials': 'F', 'LastName': 'Duška', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic. frantisek.duska@lf3.cuni.cz.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Waldauf', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Halačová', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Václav', 'Initials': 'V', 'LastName': 'Zvoníček', 'Affiliation': 'Masaryk University, Medical Faculty and U Svate Anny University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Bala', 'Affiliation': 'Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Balík', 'Affiliation': 'Charles University, 1st Faculty of Medicine and VFN University Hospital Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beneš', 'Affiliation': 'Charles University, Medical Faculty and University Hospital Plzen, Pilsen, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Klementová', 'Affiliation': 'Medical Faculty, Palacky University and Olomouc University Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Kozáková', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kubricht', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Roy', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Vymazal', 'Affiliation': 'Charles University, 2nd Faculty of Medicine, Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Řehořová', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Černý', 'Affiliation': ""Czech Anaesthesia Clinical Trials and Audit Network and Department of Anaesthesia and Intensive Care, Masaryk's Hospital, Ústí nad Labem, Czech Republic.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04566-x']
2439,32641319,Atezolizumab in patients with renal insufficiency and mixed variant histology: analyses from an expanded access program in platinum-treated locally advanced or metastatic urothelial carcinoma.,"BACKGROUND


Atezolizumab is a treatment for locally advanced/metastatic urothelial carcinoma (mUC). However, its use in patients with renal insufficiency or UC with mixed variant histology (MVH) is not well characterized.
OBJECTIVE


To report efficacy and safety of atezolizumab in these special subpopulations from an expanded access program (EAP).
DESIGN, SETTING, AND PARTICIPANTS


A total of 218 patients were enrolled at 36 US study sites (November 2015-August 2016), and the trial ended following the approval of atezolizumab by the US Food and Drug Administration. This post hoc analysis investigated outcomes in specific study subgroups.
INTERVENTION


Atezolizumab 1200 mg was administered intravenously every 3 weeks until loss of clinical benefit, unacceptable toxicity, death, consent withdrawal, decision to discontinue, commercial availability, or study closure.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Response Evaluation Criteria in Solid Tumors V.1.1 responses and safety were evaluated by baseline renal function and histology.
RESULTS AND LIMITATIONS


Objective responses occurred in 0/6 (0%), 4/19 (21%), 1/27 (3.7%), and 12/62 (19%) of evaluable patients with creatinine clearance (CrCl) <30, 30-45, 45-60, and ≥60 mL/min, respectively, and stable disease was seen in three patients with CrCl <30 mL/min. Objective responses were seen in 13/102 patients (13%) with urothelial carcinoma (UC) histology only and in 4/12 patients (33%) with UC with MVH. Treatment-related adverse event frequencies ranged from 35% to 54% across the earlier indicated CrCl subgroups and they were also similar in patients with pure UC or UC with MVH (46%).
CONCLUSIONS


In this EAP mUC subgroup analysis, clinical benefit of atezolizumab occurred in patients with compromised renal function or MVH UC tumors. Safety was comparable across subgroups.
PATIENT SUMMARY


We examined the efficacy and safety of atezolizumab for UC in certain patients participating in an EAP. We found that responses to atezolizumab occurred, and safety was similar, in most patient subgroups with varying levels of kidney functioning or less common types of tumor tissue histology.",2020,Objective responses were seen in 13/102 patients (13%) with urothelial carcinoma (UC) histology only and in 4/12 patients (33%) with UC with MVH.,"['locally advanced/metastatic urothelial carcinoma (mUC', '13/102 patients (13%) with urothelial carcinoma (UC) histology only and in 4/12 patients (33%) with UC with MVH', 'A total of 218 patients were enrolled at 36 US study sites (November 2015-August 2016', 'certain patients participating in an EAP', 'platinum-treated locally advanced or metastatic urothelial carcinoma', 'patients with renal insufficiency and mixed variant histology', 'patients with renal insufficiency or UC with mixed variant histology (MVH', 'patients with compromised renal function or MVH UC tumors']","['atezolizumab', 'Atezolizumab']","['Safety', 'creatinine clearance (CrCl', 'efficacy and safety', 'baseline renal function and histology', 'Objective responses']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",218.0,0.0487292,Objective responses were seen in 13/102 patients (13%) with urothelial carcinoma (UC) histology only and in 4/12 patients (33%) with UC with MVH.,"[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hoffman-Censits', 'Affiliation': 'Departments of Oncology and Urology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA, Baltimore, Maryland, USA jhoffm57@jhmi.edu.'}, {'ForeName': 'Sumanta', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, California, USA.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Genentech Inc, South San Francisco, California, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech Inc, South San Francisco, California, USA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Director, Bladder Cancer Program, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000419']
2440,32641330,Interventions with Music in PECTus excavatum treatment (IMPECT trial): a study protocol for a randomised controlled trial investigating the clinical effects of perioperative music interventions.,"INTRODUCTION


Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.
METHODS


A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12-18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.
ETHICS AND DISSEMINATION


This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
TRIAL REGISTRATION NUMBER


NL6863.",2020,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","['children and adolescents after pectus excavatum repair', 'patients undergoing a Nuss procedure for pectus excavatum repair', 'One hundred and seventy subjects (12-18 years of age']","['perioperative recorded music interventions', 'recorded music interventions', 'Perioperative recorded music interventions', 'perioperative music interventions']","['postoperative pain relief', 'anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness', 'self-reported perceived pain measured on the visual analogue scale', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.200294,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Billar', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands r.billar@erasmusmc.nl.""}, {'ForeName': 'A Y Rosalie', 'Initials': 'AYR', 'LastName': 'Kühlmann', 'Affiliation': 'Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.'}, {'ForeName': 'J Marco', 'Initials': 'JM', 'LastName': 'Schnater', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vlot', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Jeremy J P', 'Initials': 'JJP', 'LastName': 'Tomas', 'Affiliation': ""Anaesthesiology, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Gerda W', 'Initials': 'GW', 'LastName': 'Zijp', 'Affiliation': ""Paediatric Surgery, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Rad', 'Affiliation': ""Anaesthesiology, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Sjoerd A', 'Initials': 'SA', 'LastName': 'de Beer', 'Affiliation': ""Paediatric Surgery, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Stevens', 'Affiliation': ""Anaesthesiology, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Biostatistics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Jeekel', 'Affiliation': 'Neuroscience, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}]",BMJ open,['10.1136/bmjopen-2019-036380']
2441,32641332,"HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation.","INTRODUCTION


Tracheal intubation remains an everyday challenge for anaesthesiologists, even in patients without suspected difficult airways. The ideal positioning of the patient's head (flat, raised a few centimetres on a cushion in the sniffing position (SP), or raised to achieve horizontal alignment between the external acoustic meatus and the sternal angle) and the use of videolaryngoscopy remain controversial. This trial aims to compare the efficacy for orotracheal intubation of the SP or the head-elevated laryngoscopy position (HELP), which has been shown to improve laryngeal visualization and the intubation condition particularly in obese patients, in combination with a McGrath Mac videolaryngoscope whose video screen is either on or off (Video or NoVideo).
METHODS AND ANALYSIS


The HELP-VDL factorial trial is a prospective, randomised, parallel, multicentre, open study of 240 adult patients undergoing tracheal intubation under general anaesthesia. Patients will be allocated into four groups: SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video. The primary outcome is the proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist. The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications. Data will be analysed on the intention-to-treat principle and a per-protocol basis.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethical Committee Ile de France V (Paris, France). Participant recruitment began on 3 July 2019. The results will be submitted for publication in peer-reviewed journals. Trial registration number NCT03987009; Pre-results.",2020,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","['240 adult patients undergoing tracheal intubation under general anaesthesia', 'obese patients', 'patient population without predictable difficulty of intubation', 'patients without suspected difficult airways']","['videolaryngoscope to facilitate orotracheal intubation', 'head-elevated laryngoscopy position', 'SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video', 'head-elevated laryngoscopy position (HELP', 'HELP-VDL']","['intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications', 'proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]",240.0,0.101818,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Zoé', 'Initials': 'Z', 'LastName': 'Coppere', 'Affiliation': 'Department of Anaesthesiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, Île-de-France, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dufour', 'Affiliation': 'Department of Anaesthesiology, Institut Mutualiste Montsouris, Paris, Île-de-France, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ouattara', 'Affiliation': 'Department of Anaesthesiology, Groupe hospitalier Paris Saint-Joseph, Paris, Île-de-France, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Trichereau', 'Affiliation': 'Research Unit, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France m.fischler@orange.fr.'}]",BMJ open,['10.1136/bmjopen-2019-036570']
2442,32641334,Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.,"INTRODUCTION


Primary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.
METHODS AND ANALYSIS


Mixed methods will be used: (1) design: intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.
ETHICS AND DISSEMINATION


Favourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
TRIAL REGISTRATION NUMBER


NCT03353519; Pre-results.",2020,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).",[],"[""intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life""]",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],,0.13761,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).","[{'ForeName': 'Maria Raisa Jessica Ryc', 'Initials': 'MRJR', 'LastName': 'Aquino', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK ra532@medschl.cam.ac.uk.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Mullis', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kreit', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospital Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lim', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036879']
2443,32641335,"Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients.","INTRODUCTION


In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.
METHODS AND ANALYSIS


This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.
ETHICS AND DISSEMINATION


The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03949088).",2020,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"['patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH', 'hypotension-prone haemodialysis patients']",[],"['severe immediate complications', 'mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0388866,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Peyronel', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy francesco.peyronel@gmail.com.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Parenti', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Paride', 'Initials': 'P', 'LastName': 'Fenaroli', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giuseppe Daniele', 'Initials': 'GD', 'LastName': 'Benigno', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Rossi', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Maggiore', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiaccadori', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-036893']
2444,32641374,The Association Between HbA 1c  and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4).,"OBJECTIVE


According to recent guidelines, individuals with type 1 diabetes should spend <4.0% per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).
RESEARCH DESIGN AND METHODS


In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA 1c  levels.
RESULTS


Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA 1c  and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA 1c  <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA 1c  7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
CONCLUSIONS


Reaching current targets for time in hypoglycemia while at the same time reaching HbA 1c  targets is challenging for type 1 diabetes patients treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA 1c  levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.",2020,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","['People With Type 1 Diabetes and Multiple Daily Insulin Injections', '161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI']","['CGM', 'continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG', 'CGM and Self-Monitoring of Blood Glucose']","['mean HbA 1c  and mean glucose levels', 'mean time spent in hypoglycemia', 'time spent in hypoglycemia and various mean glucose and HbA 1c  levels', 'Time spent in hypoglycemia', 'time with glucose levels', 'mean glucose levels', 'time spent in hypoglycemia', 'HbA 1c  and Time in Hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",161.0,0.01482,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","[{'ForeName': 'Shilan', 'Initials': 'S', 'LastName': 'Seyed Ahmadi', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden shilan.seyed.ahmadi@vgregion.se.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Westman', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Arndís F', 'Initials': 'AF', 'LastName': 'Ólafsdóttir', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Dahlqvist', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, WA.'}, {'ForeName': 'Jarl', 'Initials': 'J', 'LastName': 'Hellman', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Type 1 Diabetes & Functional Insulins, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Wijkman', 'Affiliation': 'Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Schwarcz', 'Affiliation': 'Department of Medicine, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}]",Diabetes care,['10.2337/dc19-2606']
2445,32641376,Metabolic Effects of an SGLT2 Inhibitor (Dapagliflozin) During a Period of Acute Insulin Withdrawal and Development of Ketoacidosis in People With Type 1 Diabetes.,"OBJECTIVE


To determine the effect of sodium-glucose cotransporter 2 inhibitor dapagliflozin on glucose flux, lipolysis, and ketone body concentrations during insulin withdrawal in people with type 1 diabetes.
RESEARCH DESIGN AND METHODS


A double-blind, placebo-controlled crossover study with a 4-week washout period was performed in 12 people with type 1 diabetes using insulin pump therapy. Participants received dapagliflozin or placebo in random order for 7 days. Stable isotopes were infused to measure the glucose R a , R d , and lipolysis. At isotopic steady state, insulin was withdrawn, and the study was terminated after 600 min or earlier if blood glucose reached 18 mmol/L, bicarbonate <15 mmol/L, venous pH <7.35, or capillary ketones >5.0 mmol/L.
RESULTS


At baseline, glucose R a  was significantly higher for the dapagliflozin group than the placebo group. Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB) AUC 0-180 min  were significantly higher. There was a small but significantly higher glycerol R a  (measure of lipolysis) AUC 0-180 min  with dapagliflozin. Nonesterified fatty acid concentrations were not different between treatments. When divided by BMI >27 and <27 kg/m 2 , basal glucose R a , BOHB, and glycerol R a  AUC 0-180 min  were significantly higher in the low-BMI group with dapagliflozin treatment versus the low-BMI group with placebo.
CONCLUSIONS


During insulin withdrawal, the increase in BOHB with dapagliflozin may be partially due to increased lipolysis. However, reduced renal excretion, reduced BOHB uptake by peripheral tissues, or a metabolic switch to increased ketogenesis within the liver may also play a role.",2020,"Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB)","['people with type 1 diabetes', 'People With Type 1 Diabetes', '12 people with type 1 diabetes using insulin pump therapy']","['dapagliflozin or placebo', 'dapagliflozin', 'SGLT2 Inhibitor (Dapagliflozin', 'sodium-glucose cotransporter 2 inhibitor dapagliflozin', 'placebo']","['glycerol R a  (measure of lipolysis', 'glucose flux, lipolysis, and ketone body concentrations', 'Nonesterified fatty acid concentrations', 'reduced renal excretion, reduced BOHB uptake', 'plasma glucose concentrations', 'glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB', 'basal glucose R a , BOHB, and glycerol R a  AUC 0-180 min']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]",12.0,0.111194,"Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB)","[{'ForeName': 'Roselle A', 'Initials': 'RA', 'LastName': 'Herring', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K. roselle.herring@nhs.net.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shojaee-Moradie', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garesse', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stevenage', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Fielding', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Agampodi', 'Initials': 'A', 'LastName': 'Mendis', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Johnsen', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'A Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Russell-Jones', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}]",Diabetes care,['10.2337/dc19-2579']
2446,32641379,Impact of Acarbose on Incident Diabetes and Regression to Normoglycemia in People With Coronary Heart Disease and Impaired Glucose Tolerance: Insights From the ACE Trial.,"OBJECTIVE


We examined the impact of acarbose, an α-glucosidase inhibitor, on incident diabetes and regression to normoglycemia in 6,522 Acarbose Cardiovascular Evaluation trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD).
RESEARCH DESIGN AND METHODS


Participants were randomly assigned to acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests. Incident diabetes was defined as two successive diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose (PG) levels ≥11.1 mmol/L while taking study medication or a masked adjudicated confirmation of this diagnosis. Regression to normoglycemia was defined as FPG <6.1 mmol/L and 2-h PG <7.8 mmol/L. Intention-to-treat and on-treatment analyses were conducted using Poisson regression models, overall and for subgroups (age, sex, coronary heart disease [CHD] type, HbA 1c , FPG, 2-h PG, BMI, estimated glomerular filtration rate, for IGT alone, IGT + impaired fasting glucose, and use of thiazides, ACE inhibitors [ACEis]/angiotensin receptor blockers [ARBs], β-blockers, calcium channel blockers, or statins).
RESULTS


Incident diabetes was less frequent with acarbose compared with placebo (3.2 and 3.8 per 100 person-years, respectively; rate ratio 0.82 [95% CI 0.71, 0.94];  P  = 0.005), with no evidence of differential effects within the predefined subgroups after accounting for multiple testing. Regression to normoglycemia occurred more frequently in those randomized to acarbose compared with placebo (16.3 and 14.1 per 100 person-years, respectively; 1.16 [1.08, 1.25],  P  < 0.0001). This effect was greater in participants not taking an ACEi or ARB (1.36 [1.21, 1.53],  P   interaction  = 0.0006). The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
CONCLUSIONS


Acarbose reduced the incidence of diabetes and promoted regression to normoglycemia in Chinese people with IGT and CHD.",2020,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
","['Chinese people with IGT and CHD', 'Participants', 'People With Coronary Heart Disease and Impaired Glucose Tolerance', '6,522 Acarbose Cardiovascular Evaluation trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD']","['acarbose', 'acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests', 'Acarbose', 'placebo']","['likelihood of remaining in normoglycemic regression', 'diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose', 'Regression to normoglycemia', 'PG) levels']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0948955', 'cui_str': 'Cardiovascular evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.176977,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Department of Medicine and Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada gerstein@mcmaster.ca.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Shishi', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2046']
2447,32641470,Naproxen chemoprevention promotes immune activation in Lynch syndrome colorectal mucosa.,"OBJECTIVE


Patients with Lynch syndrome (LS) are at markedly increased risk for colorectal cancer. It is being increasingly recognised that the immune system plays an essential role in LS tumour development, thus making an ideal target for cancer prevention. Our objective was to evaluate the safety, assess the activity and discover novel molecular pathways involved in the activity of naproxen as primary and secondary chemoprevention in patients with LS.
DESIGN


We conducted a Phase Ib, placebo-controlled, randomised clinical trial of two dose levels of naproxen sodium (440 and 220 mg) administered daily for 6 months to 80 participants with LS, and a co-clinical trial using a genetically engineered mouse model of LS and patient-derived organoids (PDOs).
RESULTS


Overall, the total number of adverse events was not different across treatment arms with excellent tolerance of the intervention. The level of prostaglandin E2 in the colorectal mucosa was significantly decreased after treatment with naproxen when compared with placebo. Naproxen activated different resident immune cell types without any increase in lymphoid cellularity, and changed the expression patterns of the intestinal crypt towards epithelial differentiation and stem cell regulation. Naproxen demonstrated robust chemopreventive activity in a mouse co-clinical trial and gene expression profiles induced by naproxen in humans showed perfect discrimination of mice specimens with LS and PDOs treated with naproxen and control.
CONCLUSIONS


Naproxen is a promising strategy for immune interception in LS. We have discovered naproxen-induced gene expression profiles for their potential use as predictive biomarkers of drug activity.
TRIAL REGISTRATION NUMBER


gov Identifier: NCT02052908.",2020,The level of prostaglandin E2 in the colorectal mucosa was significantly decreased after treatment with naproxen when compared with placebo.,"['patients with LS', 'Lynch syndrome colorectal mucosa', 'Patients with Lynch syndrome (LS', '80 participants with LS, and a co-clinical trial using a genetically engineered mouse model of LS and patient-derived organoids (PDOs']","['naproxen sodium', 'naproxen', 'Naproxen', 'Naproxen chemoprevention', 'placebo']","['chemopreventive activity', 'total number of adverse events', 'level of prostaglandin E2 in the colorectal mucosa']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017387', 'cui_str': 'Engineering, Genetic'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0029250', 'cui_str': 'Organoids'}]","[{'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}]",80.0,0.220314,The level of prostaglandin E2 in the colorectal mucosa was significantly decreased after treatment with naproxen when compared with placebo.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Reyes-Uribe', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Gelincik', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Prashant V', 'Initials': 'PV', 'LastName': 'Bommi', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Francisco-Cruz', 'Affiliation': 'Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Luisa M', 'Initials': 'LM', 'LastName': 'Solis', 'Affiliation': 'Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Lynch', 'Affiliation': 'Department of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""Department of Gastroenterology, Dana Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Stoffel', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kanth', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Utah/Huntsman Cancer Institute, Salt Lake City, Utah, USA.'}, {'ForeName': 'N Jewel', 'Initials': 'NJ', 'LastName': 'Samadder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Mork', 'Affiliation': 'Clinical Cancer Genetics Program, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Melissa W', 'Initials': 'MW', 'LastName': 'Taggart', 'Affiliation': 'Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ginger L', 'Initials': 'GL', 'LastName': 'Milne', 'Affiliation': 'Departments of Biochemistry, Medicine and Pharmacology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Marnett', 'Affiliation': 'Departments of Biochemistry, Medicine and Pharmacology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vornik', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Revuelta', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Y Nancy', 'Initials': 'YN', 'LastName': 'You', 'Affiliation': 'Clinical Cancer Genetics Program, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Levy', 'Initials': 'L', 'LastName': 'Kopelovich', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Ignacio I', 'Initials': 'II', 'LastName': 'Wistuba', 'Affiliation': 'Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Shizuko', 'Initials': 'S', 'LastName': 'Sei', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shoemaker', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Perloff', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Powel H', 'Initials': 'PH', 'LastName': 'Brown', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Lipkin', 'Affiliation': 'Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Vilar', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA evilar@mdanderson.org.'}]",Gut,['10.1136/gutjnl-2020-320946']
2448,32646462,"Corifollitropin alfa for poor responders patients, a prospective randomized study.","BACKGROUND


Poor ovarian response remains one of the biggest challenges for reproductive endocrinologists. The introduction of corifollitropin alpha (CFA) offered an alternative option to other gonadotropins for its longer half-life, its more rapid achievement of the threshold and higher FSH levels. We compared two different protocols with CFA, a long agonist and a short antagonist, and a no-CFA protocol.
METHODS


Patients enrolled fulfilled at least two of the followings: AFC < 5, AMH < 1,1 ng/ml, less than three oocytes in a previous cycle, age > 40 years. Ovarian stimulation with an antagonist protocol was performed either with 300 UI rFSH and 150 UI rLH or 300UI HMG. In the long agonist group, after pituitary suppression with triptorelin, CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. In the short antagonist group CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. The primary objective was the effect on the number of oocytes and MII oocytes. Secondary objective were pregnancy rates, ongoing pregnancies and ongoing pregnancies per intention to treat.
RESULTS


The use of CFA resulted in a shorter lenght of stimulation and a lower number of suspended treatments. Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol. Both CFA groups yielded higher pregnancy rates, especially the long protocol, due to the higher number of oocytes retrieved (p < 0,05), as implantation rates did not differ. The cumulative pregnancy rate was also different, due to the higher number of cryopreserved blastocysts (p < 0,02).
CONCLUSIONS


The long agonist protocol with the addition of rFSH and rLH showed the best results in all the parameters. A short antagonist protocol with CFA was less effective, but not significantly, although provided better results compared to the no-CFA group. We suggest that a long agonist protocol with CFA and recombinant gonadotropins might be a valuable option for poor responders.
TRIAL REGISTRATION


The study was approved by the local Ethics Committee (EudraCT2015-002817-31).",2020,"Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol.","['Patients enrolled fulfilled at least two of the followings', 'poor responders patients']","['rFSH and rLH', 'corifollitropin alpha (CFA', 'CFA', 'AFC <\u20095, AMH', 'triptorelin, CFA', 'Corifollitropin alfa', 'CFA and recombinant gonadotropins']","['cumulative pregnancy rate', 'pregnancy rates, ongoing pregnancies and ongoing pregnancies per intention to treat', 'implantation rates', 'pregnancy rates', 'number of oocytes and MII oocytes', 'number of retrieved oocytes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C2713522', 'cui_str': 'corifollitropin alfa'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.116864,"Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol.","[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Fusi', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy. ffusi@asst-pg23.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zanga', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnoldi', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Melis', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappato', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Candeloro', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Pasqua', 'Affiliation': 'Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.'}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00628-6']
2449,32646482,Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial.,"BACKGROUND


Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes mellitus is associated with pregnancy-related maternal and fetal morbidity (both antenatal and perinatal). Myo-inositol has been suggested to improve insulin resistance in women with polycystic ovary syndrome. The aim of this study is to examine the impact of myo-inositol supplementation during pregnancy on the incidence of gestational diabetes mellitus.
METHODS


We will conduct a single-center, open-label, randomized controlled trial. A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80). The intervention group will receive myo-inositol and folic acid (4000 mg myo-inositol and 400 mcg folic acid daily) from 11 to 13 +6  weeks of gestation until 26-28 weeks of gestation, while the control group will receive folic acid alone (400 mcg folic acid daily) for the same period of time as intervention group. The primary outcome will be gestational diabetes incidence rate at 26-28 weeks of gestation, according to the results of a 75 g oral glucose tolerance test held at 26-28 weeks of gestation. The secondary outcomes will include fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy at 26-28 weeks of gestation.
DISCUSSION


This trial will provide evidence for the effectiveness of myo-inositol supplementation during pregnancy in reducing the incidence of gestational diabetes mellitus.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN16142533 . Registered on 9 March 2017.",2020,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"['gestational diabetes mellitus', '160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation', 'women with polycystic ovary syndrome', 'Gestational diabetes mellitus', 'Gestational diabetes mellitus (GDM']","['myo-inositol and folic acid (4000\u2009mg myo-inositol and 400\xa0mcg folic acid daily', 'folic acid alone', 'dietary myo-inositol supplementation', 'myo-inositol supplementation']","['insulin resistance', 'fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy', 'gestational diabetes incidence rate']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",160.0,0.176481,A total of 160 healthy pregnant women with singleton pregnancy at 11-13 +6  weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80).,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Asimakopoulos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece. asimakopoulos.geo5@gmail.com.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Pergialiotis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Anastasiou', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Antsaklis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Theodora', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Vogiatzi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Aggela', 'Initials': 'A', 'LastName': 'Kallergi', 'Affiliation': 'Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sindos', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Loutradis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Daskalakis', 'Affiliation': 'First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.'}]",Trials,['10.1186/s13063-020-04561-2']
2450,32646498,"Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study.","BACKGROUND


This study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT).
METHODS


This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n = 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n = 171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period.
RESULTS


In a mixed-effects model for repeated measures, the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), significantly declined in both the tofogliflozin (- 0.132 mm, SE 0.007; - 0.163 mm, SE 0.013; - 0.170 mm, SE 0.020, respectively) and the control group (- 0.140 mm, SE 0.006; - 0.190 mm, SE 0.012; - 0.190 mm, SE 0.020, respectively). Furthermore, the tofogliflozin and the conventional treatment group did not significantly differ in the progression of the mean-IMT-CCA (mean change (95% CI) 0.008 (- 0.009, 0.025) mm, P = 0.34), along with the right (mean change (95% CI) 0.027 (- 0.005, 0.059) mm, P = 0.10) and the left max-IMT-CCA (mean change (95% CI) 0.020 (- 0.030, 0.070), P = 0.43). Similar findings were obtained even after adjusting for traditional CV risk factors and/or administration of drugs at baseline. Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C. The total and serious adverse events incidences did not significantly vary between the treatment groups.
CONCLUSIONS/INTERPRETATION


No IMT changes were observed between the tofogliflozin and the conventional treatment groups. However, tofogliflozin is a safe and effective treatment option for managing primary CVD risk factors in this population. Clinical Trial Registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).",2020,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","['340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units', 'type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT', 'patients with type 2 diabetes']","['tofogliflozin', 'Tofogliflozin', 'tofogliflozin treatment group (n\u2009=\u2009169) or conventional treatment group using drugs other than SGLT2 inhibitors', 'tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor']","['carotid atherosclerosis', 'changes in mean and maximum common carotid IMT', 'HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C', 'progression of the mean-IMT-CCA', 'mean IMT of the common carotid artery', 'left max-IMT-CCA', 'IMT changes', 'total and serious adverse events incidences']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",340.0,0.0458559,"Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Mita', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yoshii', 'Affiliation': 'Department of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara City, Osaka, 582-0005, Japan.'}, {'ForeName': 'Tetsuyuki', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Umayahara', 'Affiliation': 'Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.'}, {'ForeName': 'Tsunehiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki City, Hyogo, Japan.'}, {'ForeName': 'Nobuichi', 'Initials': 'N', 'LastName': 'Kuribayashi', 'Affiliation': 'Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi City, Chiba, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Kitasenri Maeda Clinic, 4-119 Furuedai, Suita, Osaka, 565-0874, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kosugi', 'Affiliation': 'Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ohtoshi', 'Affiliation': 'Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Clinic, 3-9-23 Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sumitani', 'Affiliation': 'Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Tsugawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Ryomoto', 'Affiliation': 'Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Taki', 'Affiliation': 'Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01079-4']
2451,32646501,The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial.,"BACKGROUND


Rubus coreanus (R. coreanus) possesses properties that may decrease cholesterol levels.
METHODS


The effects of unripe R. coreanus (uRC) consumption on low-density lipoprotein (LDL) and total cholesterol levels related to decreased circulating apolipoprotein (Apo) B and oxidized LDL levels were evaluated. This randomized, double-blind, placebo-controlled study included subjects with borderline-high cholesterol levels (between 200 and 239 mg/dL) who consumed one capsule daily containing 600 mg of freeze-dried uRC extract (n = 39) or the placebo (n = 38).
RESULTS


After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032). In addition, significantly greater reductions in Apo B levels were observed in the uRC group (- 3.48 ± 3.40 mg/dL), but Apo B levels were increased in the placebo group (6.21 ± 2.84 mg/dL; P = 0.032). Furthermore, a remarkably lower oxidized LDL level was detected in the uRC group (57.76 ± 2.07 U/L) than in the placebo group (66.09 ± 3.47 U/L) after 12 weeks of consumption (P = 0.044).
CONCLUSIONS


Because of its cholesterol-lowering effect, uRC shows great promise as a therapeutic agent for subjects with borderline-high total blood cholesterol levels.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03649620 (8/28/2018, retrospectively registered).",2020,"After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032).","['n\u2009=\u200939) or the', 'subjects with borderline-high total blood cholesterol levels', 'n\u2009=\u200938', 'subjects with borderline-high cholesterol levels (between 200 and 239\u2009mg/dL) who', 'subjects with borderline-high cholesterol levels']","['unripe R. coreanus (uRC) consumption', 'consumed one capsule daily containing 600\u2009mg of freeze-dried uRC extract', 'placebo']","['oxidized LDL and apolipoprotein B levels', 'low-density lipoprotein (LDL) and total cholesterol levels', 'Apo B levels', 'total cholesterol levels', 'oxidized LDL level', 'circulating apolipoprotein (Apo) B and oxidized LDL levels', 'LDL cholesterol levels']","[{'cui': 'C2711208', 'cui_str': 'Borderline high'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",,0.339507,"After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032).","[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Jisuk', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Sa Rang', 'Initials': 'SR', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Moon', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju, Republic of Korea.'}, {'ForeName': 'Sunoh', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'B&Tech Co., Ltd., R&D Center, Gwangju, 61239, South Korea. sunoh@korea.ac.kr.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea. jhleeb@yonsei.ac.kr.'}]",Lipids in health and disease,['10.1186/s12944-020-01338-z']
2452,32646563,10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents.,"BACKGROUND


Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.
OBJECTIVES


Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.
METHODS


A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.
RESULTS


The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).
CONCLUSIONS


At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533).",2020,"The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22).","['patients with coronary artery disease treated with', 'patients enrolled in the ISAR-TEST-5 (Test Efficacy of', '3,002 patients']","['Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents', 'polymer-free sirolimus- and probucol-eluting stents (n\xa0=\xa02,002) or durable polymer zotarolimus-eluting stents', 'Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5', 'Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents', 'drug-eluting stents (DES']","['incidence of definite/probable stent thrombosis', 'patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis', 'High overall adverse clinical event rates', 'rates of DOCE and POCE', 'incidence of stent thrombosis', 'composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0033215', 'cui_str': 'Probucol'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",3002.0,0.111941,"The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: Sebastian.Kufner@gmx.de.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Colleran', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Koppara', 'Affiliation': 'Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie und Pneumologie), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie und Pneumologie), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fusaro', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'German Center for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany; Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie und Pneumologie), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Dublin Cardiovascular Research Institute, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.026']
2453,32646655,"Comment on Chun et al, ""A Randomized Phase II Study of Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab in Patients With Upfront Resectable Hepatic Colorectal Metastases"".",,2020,,['Patients'],['Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]",[],,0.0186827,,"[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gelsomino', 'Affiliation': 'Division of Oncology, Department of Oncology and Haematology, University Hospital of Modena, Modena, Italy. Electronic address: fabiogelsomino83@yahoo.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Spallanzani', 'Affiliation': 'Division of Oncology, Department of Oncology and Haematology, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei-Gardini', 'Affiliation': 'Division of Oncology, Department of Oncology and Haematology, University Hospital of Modena, Modena, Italy.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.06.002']
2454,32646701,Prognostic Impact of Race in Patients Undergoing PCI: Analysis From 10 Randomized Coronary Stent Trials.,"OBJECTIVES


The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials.
BACKGROUND


Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies.
METHODS


Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates.
RESULTS


Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01).
CONCLUSIONS


In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences.",2020,"Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07).","['22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic', 'patients undergoing', 'Patients Undergoing PCI']",['percutaneous coronary intervention'],"['black race and 5-year risk for major adverse cardiac events', 'adverse cardiac event rates', 'death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization', 'Hispanic ethnicity and Asian race']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]",22638.0,0.388146,"Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07).","[{'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Golomb', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York; Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG, National University of Ireland, Galway, Ireland; Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gregg.stone@mountsinai.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.020']
2455,32646707,The CHOICE Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.2772,,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bisson', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Fauchier', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Collart', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.049']
2456,32646709,Reply: The CHOICE Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.229563,,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Mitsunobu', 'Initials': 'M', 'LastName': 'Kitamura', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.05.044']
2457,32646746,Physiological factors determining downhill vs uphill running endurance performance.,"OBJECTIVES


Recent studies investigated the determinants of trail running performance (i.e., combining uphill (UR) and downhill running sections (DR)), while the possible specific physiological factors specifically determining UR vs DR performances (i.e., isolating UR and DR) remain presently unknown. This study aims to determine the cardiorespiratory responses to outdoor DR vs UR time-trial and explore the determinants of DR and UR performance in highly trained runners.
DESIGN


Randomized controlled trial.
METHODS


Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity. Predictors of DR and UR performance were investigated using correlation and commonality regression analyses.
RESULTS


Running velocity was higher in DR vs UR time-trial (20.4±1.0 vs 12.0±0.5km·h -1 , p<0.05) with similar average heart rate (95±2% vs 94±2% maximal heart rate; p>0.05) despite lower average V̇O 2  (85±8% vs 89±7% V̇O 2max ; p<0.05). Velocity at V̇O 2max  (vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
CONCLUSIONS


Five-km UR and DR running performances are both well explained by three independent predictors. If two predictors are shared between UR and DR performances (vV̇O 2max  and maximal strength), their relative contribution is different and, importantly, the third predictor appears very specific to the exercise modality (BMI for UR vs leg musculotendinous stiffness for DR).",2020,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
","['Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for', 'highly trained runners']",['combining uphill (UR) and downhill running sections (DR'],"['UR and DR running performances', 'Running velocity', 'vV̇O 2max ) body mass index (BMI) and maximal extensor strength', 'vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength', 'UR and DR performances (vV̇O 2max  and maximal strength', 'Velocity at V̇O 2max', 'average heart rate', 'UR performance', 'DR and UR performance', 'maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",10.0,0.0353636,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lemire', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France. Electronic address: marcel.lemire@unistra.fr.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Favret', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Geny', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Blah Y L', 'Initials': 'BYL', 'LastName': 'Kouassi', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Boukhari', 'Affiliation': 'University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Lonsdorfer', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Remetter', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Stéphane P', 'Initials': 'SP', 'LastName': 'Dufour', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.004']
2458,32646850,Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial.,"The PRECISION trial was a multicentre randomised study that demonstrated that multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy is superior to standard transrectal ultrasound-guided biopsy for the detection of prostate cancer. The outcomes of studies reporting mpMRI-targeted biopsies are dependent on the quality of the mpMRI but there are currently no scoring systems available for evaluating this. We introduced a novel scoring system, the Prostate Imaging Quality (PI-QUAL) score, to assess the quality of scans in the PRECISION trial. PI-QUAL is a score on a Likert scale from 1 to 5, where 1 means that no mpMRI sequences are of diagnostic quality and 5 implies that each sequence is independently of optimal diagnostic quality. Fifty-eight out of 252 (23%) mpMRI scans chosen at random from each of the 22 centres in this trial were evaluated by two experienced radiologists from the coordinating trial centre, in consensus, blinded to pathology results. Overall, the mpMRI quality in the centres participating in PRECISION was good. MpMRI quality was of sufficient diagnostic quality (PI-QUAL ≥3) for 55 scans (95%) and of good or optimal diagnostic quality (PI-QUAL ≥4) for 35 scans (60%). Fifty-five out of 58 (95%) scans were of diagnostic quality for T2WI, followed by DWI (46/58 scans; 79%), and DCE (38/58 scans; 66%). Further validation of this scoring system is warranted. PATIENT SUMMARY: In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection. We used scans from 22 centres that participated in the PRECISION trial. Although there was room for improvement in images that used intravenous contrast, we found that mpMRI in the PRECISION trial was of sufficient diagnostic quality (PI-QUAL score ≥3) for 95% of the scans.",2020,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"['prostate cancer detection', 'Fifty-eight out of 252 (23']","['multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy', 'standard transrectal ultrasound-guided biopsy', 'Prostate Imaging Quality (PI-QUAL', 'multiparametric magnetic resonance imaging (mpMRI']","['diagnostic quality', 'MpMRI quality', 'mpMRI quality', 'Prostate Imaging Quality (PI-QUAL) score']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.0461845,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK; Division of Surgery & Interventional Science, University College London, London, UK. Electronic address: f.giganti@ucl.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Moore', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Veeru', 'Initials': 'V', 'LastName': 'Kasivisvanathan', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.06.007']
2459,32647023,Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.,"INTRODUCTION


Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has  never  been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the 'REthinking Clinical Trials' (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The 'REaCT-NSQIP' trial design has great potential to efficiently generate level I evidence for other perioperative interventions.
METHODS AND ANALYSIS


SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the 'integrated consent model', and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.
ETHICS AND DISSEMINATION


This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03663504; Pre-results, recruitment phase.",2020,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","['67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol', 'surgical patients', 'elective colon surgery']","['elective colorectal surgery after preoperative OA or no preparation', 'preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP', 'REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone', 'National Surgical Quality Improvement Program (NSQIP']","['length of stay, reduced costs and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.153862,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","[{'ForeName': 'Sameer S', 'Initials': 'SS', 'LastName': 'Apte', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ahwon', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandemeer', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Suh', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Auer', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada rauer@ohri.ca.'}]",BMJ open,['10.1136/bmjopen-2020-036866']
2460,32525432,Leucine-enriched amino acids maintain peripheral mTOR-Rheb localization independent of myofibrillar protein synthesis and mTORC1 signaling postexercise.,"Postexercise protein ingestion can elevate rates of myofibrillar protein synthesis (MyoPS), mTORC1 activity, and mTOR translocation/protein-protein interactions. However, it is unclear if leucine-enriched essential amino acids (LEAA) can similarly facilitate intracellular mTOR trafficking in humans after exercise. The purpose of this study was to determine the effect of postexercise LEAA (4 g total EAAs, 1.6 g leucine) on acute MyoPS and mTORC1 translocation and signaling. Recreationally active men performed lower-body resistance exercise (5 × 8-10 leg press and leg extension) to volitional failure. Following exercise participants consumed LEAA ( n  = 8) or an isocaloric carbohydrate drink (PLA;  n  = 10). MyoPS was measured over 1.5-4 h of recovery by oral pulse of l-[ ring - 2 H 5 ]-phenylalanine. Phosphorylation of proteins in the mTORC1 pathway were analyzed via immunoblotting and mTORC1-LAMP2/WGA/Rheb colocalization via immunofluorescence microscopy. There was no difference in MyoPS between groups (LEAA = 0.098 ± 0.01%/h; PL = 0.090 ± 0.01%/h;  P  > 0.05). Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05). LAT1 and SNAT2 protein expression were not affected by exercise or nutrient ingestion. mTOR-LAMP2 colocalization was greater in LEAA preexercise and decreased following exercise and supplement ingestion ( P  < 0.05), yet was unchanged in PLA. mTOR-WGA (cell periphery marker) and mTOR-Rheb colocalization was greater in LEAA compared with PLA irrespective of time-point ( P  < 0.05). In conclusion, the postexercise consumption of 4 g of LEAA maintains mTOR in peripheral regions of muscle fibers, in closer proximity to its direct activator Rheb, during prolonged recovery independent of differences in MyoPS or mTORC1 signaling compared with PLA ingestion. This intracellular localization of mTOR may serve to ""prime"" the kinase for future anabolic stimuli. NEW & NOTEWORTHY  This is the first study to investigate whether postexercise leucine-enriched amino acid (LEAA) ingestion elevates mTORC1 translocation and protein-protein interactions in human skeletal muscle. Here, we observed that although LEAA ingestion did not further elevate postexercise MyoPS or mTORC1 signaling compared with placebo, mTORC1 peripheral location and interaction with Rheb were maintained. This may serve to ""prime"" mTORC1 for subsequent anabolic stimuli.",2020,"Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05).",['human skeletal muscle'],"['body resistance exercise', 'isocaloric carbohydrate drink', 'Leucine-enriched amino acids', 'l', 'postexercise LEAA (4 g total EAAs, 1.6 g leucine', 'postexercise leucine-enriched amino acid (LEAA) ingestion', 'exercise participants consumed LEAA', 'phenylalanine', 'Postexercise protein ingestion']","['mTOR-Rheb colocalization', 'LEAA preexercise', 'Exercise', 'myofibrillar protein synthesis (MyoPS), mTORC1 activity, and mTOR translocation/protein-protein interactions', 'mTOR', 'acute MyoPS and mTORC1 translocation and signaling', 'LAT1 and SNAT2 protein expression', 'MyoPS']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C3888046', 'cui_str': 'Target of Rapamycin Complex 1'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0596271,"Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05).","[{'ForeName': 'Sarkis J', 'Initials': 'SJ', 'LastName': 'Hannaian', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hodson', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Abou Sawan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mazzulla', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Technology Development Center, Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Matsunaga', 'Affiliation': 'Technology Development Center, Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Waskiw-Ford', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Duncan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Dinesh A', 'Initials': 'DA', 'LastName': 'Kumbhare', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00241.2020']
2461,32191814,"Ferrous sulfate oral solution in young children with iron deficiency anemia: An open-label trial of efficacy, safety, and acceptability.","BACKGROUND


This study evaluated the efficacy, safety, and acceptability of a new ferrous sulfate oral solution (Tardyferon® 20 mg/mL) in young children with mild or moderate iron deficiency anemia (IDA).
METHODS


This was a multicenter, national, single-arm, open-label study. Children aged 6-53 months presenting with mild or moderate IDA (i.e., blood hemoglobin (Hb) ranging from 7.0 to 10.9 g/dL and serum ferritin <12 ng/mL) were eligible for inclusion. The ferrous sulfate heptahydrate solution (2 mg/kg/day) was administered orally for 3 months. If normalization of either Hb or ferritin was not achieved at month 3 the treatment was continued for another 3 months.
RESULTS


Of the 100 children screened, 21 aged 6-17 months were included and received the study treatment, and 19 were analyzed for hematologic outcomes at month 3. Only one patient continued treatment for the additional 3 months. At month 3, mean ± SD Hb and ferritin levels were 12.0 ± 0.7 g/dL and 31.5 ± 19.4 ng/mL, respectively. Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively. Treatment compliance and levels of satisfaction of both the parents and the investigators were high. Overall, 33.3% of patients (7/21) experienced at least one adverse event. Only one patient (4.8%) experienced a drug-related adverse event (upper abdominal pain).
CONCLUSIONS


A 2 mg/kg daily dose of the new oral ferrous sulfate heptahydrate solution provides substantial therapeutic benefit with high levels of tolerability in young children who have mild or moderate IDA.",2020,"Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively.","['100 children screened, 21 aged 6-17\xa0months', 'Children aged 6-53\xa0months presenting with mild or moderate IDA (i.e.,\xa0blood hemoglobin (Hb) ranging from\xa07.0\xa0to\xa010.9\xa0g/dL and serum ferritin <12\xa0ng/mL) were eligible for inclusion', 'young children with mild or moderate iron deficiency anemia (IDA', 'young children who have mild or moderate IDA', 'young children with iron deficiency anemia']","['new ferrous sulfate oral solution (Tardyferon® 20\xa0mg/mL', 'Ferrous sulfate oral solution', 'ferrous sulfate heptahydrate solution']","['Hemoglobin and ferritin levels', 'efficacy, safety, and acceptability', 'mean ± SD Hb and ferritin levels', 'drug-related adverse event (upper abdominal pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1246232', 'cui_str': 'ferrous sulfate Oral Solution'}, {'cui': 'C0075817', 'cui_str': 'tardyferon'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0970110', 'cui_str': 'Ferrous sulfate heptahydrate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232492', 'cui_str': 'Upper abdominal pain'}]",21.0,0.0787444,"Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Pachuta Węgier', 'Affiliation': 'Lidia Pachuta Węgier Medical Services, Lublin, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kubiak', 'Affiliation': 'Tolek Clinic for Children, Lesznowola, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Liebert', 'Affiliation': 'Tolek Clinic for Children, Lesznowola, Poland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Clavel', 'Affiliation': 'TCC Consulting, Revel, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Clinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Stennevin', 'Affiliation': 'Clinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Roye', 'Affiliation': 'Clinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.'}, {'ForeName': 'Asmaa', 'Initials': 'A', 'LastName': 'Boudribila', 'Affiliation': 'Clinical Development Department, Institut de Recherche Pierre Fabre, CRDPF, Toulouse, France.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14237']
2462,30272192,Lung cancer screening: does pulmonary nodule detection affect a range of smoking behaviours?,"BACKGROUND


Lung cancer screening can reduce lung cancer mortality by 20%. Screen-detected abnormalities may provide teachable moments for smoking cessation. This study assesses impact of pulmonary nodule detection on smoking behaviours within the first UK trial of a novel auto-antibody test, followed by chest x-ray and serial CT scanning for early detection of lung cancer (Early Cancer Detection Test-Lung Cancer Scotland Study).
METHODS


Test-positive participants completed questionnaires on smoking behaviours at baseline, 1, 3 and 6 months. Logistic regression compared outcomes between nodule (n = 95) and normal CT groups (n = 174) at 3 and 6 months follow-up.
RESULTS


No significant differences were found between the nodule and normal CT groups for any smoking behaviours and odds ratios comparing the nodule and normal CT groups did not vary significantly between 3 and 6 months. There was some evidence the nodule group were more likely to report significant others wanted them to stop smoking than the normal CT group (OR across 3- and 6-month time points: 3.04, 95% CI: 0.95, 9.73; P = 0.06).
CONCLUSION


Pulmonary nodule detection during lung cancer screening has little impact on smoking behaviours. Further work should explore whether lung cancer screening can impact on perceived social pressure and promote smoking cessation.",2019,No significant differences were found between the nodule and normal CT groups for any smoking behaviours and odds ratios comparing the nodule and normal CT groups did not vary significantly between 3 and 6 months.,"['Lung cancer screening', 'Test-positive participants completed questionnaires on smoking behaviours at baseline, 1, 3 and 6 months']","['novel auto-antibody test, followed by chest x-ray and serial CT scanning']","['smoking behaviours and odds ratios', 'smoking behaviours', 'lung cancer mortality']","[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0213932,No significant differences were found between the nodule and normal CT groups for any smoking behaviours and odds ratios comparing the nodule and normal CT groups did not vary significantly between 3 and 6 months.,"[{'ForeName': 'Marcia E', 'Initials': 'ME', 'LastName': 'Clark', 'Affiliation': 'Division of Primary Care, Floor 13, Tower Building, University Park, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Division of Primary Care, Floor 13, Tower Building, University Park, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Bedford', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, Northern Ireland.""}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Institute of Mental Health, Jubilee Campus, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': ""Faculty of Medicine and Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Division of Primary Care, Floor 13, Tower Building, University Park, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of St Andrews, North Haugh, St Andrews, UK.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'Head of General Practice and Primary Care, Institute of Health and Wellbeing, MVLS, University of Glasgow, 1 Horselethill Road, Glasgow, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Schembri', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Roberta C', 'Initials': 'RC', 'LastName': 'Littleford', 'Affiliation': 'Tayside Clinical Trials Unit (TCTU), Tayside Medical Science Centre (TASC), University of Dundee, School of Medicine, Ninewells Hospital and Medical School, Residency Block, Level 3, George Pirie Way, Dundee, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, Floor 13, Tower Building, University Park, University of Nottingham, Nottingham, UK.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy158']
2463,30792370,Oral chloral hydrate versus intranasal dexmedetomidine for sedation of children undergoing computed tomography: a multicentre study.,,2019,,['children undergoing computed tomography'],['Oral chloral hydrate versus intranasal dexmedetomidine'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008161', 'cui_str': 'chloral hydrate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0274635,,"[{'ForeName': 'V M Y', 'Initials': 'VMY', 'LastName': 'Yuen', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong Shenzhen Hospital.'}, {'ForeName': 'D K L', 'Initials': 'DKL', 'LastName': 'Cheuk', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Queen Mary Hospital.'}, {'ForeName': 'T W C', 'Initials': 'TWC', 'LastName': 'Hui', 'Affiliation': 'Department of Anaesthesiology, Queen Mary Hospital.'}, {'ForeName': 'I C K', 'Initials': 'ICK', 'LastName': 'Wong', 'Affiliation': 'UCL School of Pharmacy, London, UK.'}, {'ForeName': 'W W M', 'Initials': 'WWM', 'LastName': 'Lam', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Irwin', 'Affiliation': 'Department of Anaesthesiology, The University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
2464,30792371,Mirror therapy with bilateral arm training for hemiplegic upper extremity motor functions in patients with chronic stroke.,,2019,,['patients with chronic stroke'],['Mirror therapy with bilateral arm training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0105286,,"[{'ForeName': 'K N K', 'Initials': 'KNK', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Ting', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University.'}, {'ForeName': 'C C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University.'}, {'ForeName': 'L S W', 'Initials': 'LSW', 'LastName': 'Li', 'Affiliation': 'Tung Wah Hospital.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
2465,30913049,Effects of Platelet-Rich Plasma on Aesthetic Outcomes of Maxillofacial Surgical Procedures.,,2020,,[],['Platelet-Rich Plasma'],[],[],"[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]",[],,0.0181269,,"[{'ForeName': 'Menchisheva', 'Initials': 'M', 'LastName': 'Yuliya', 'Affiliation': 'Department of Surgical Dentistry, Maxillofacial Department of the Hospital N5, S.D. Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan Department of Surgical Dentistry, S.D. Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan.'}, {'ForeName': 'Mirzakulova', 'Initials': 'M', 'LastName': 'Ulmeken', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001794']
2466,30964785,Assessment of Psychological Well-being After AbobotulinumtoxinA Treatment: A Comparison of 2 Reconstitution Volumes.,,2020,,[],[],[],[],[],[],,0.016334,,"[{'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': 'AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado Department of Dermatology, University of California Irvine, Irvine, California Skin Associates of South Florida, Skin Research Institute, Coral Gables, Florida Skinfluence, New York, New York Zenith Healthcare Communications Limited, Chester, United Kingdom Galderma Laboratories, L.P., Fort Worth, Texas.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'Marina I', 'Initials': 'MI', 'LastName': 'Peredo', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Down', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Mashburn', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000001940']
2467,31119913,Preliminary evidence of effectiveness of TECAR in lymphedema.,"Lymphedema of the lower limbs often contributes to the mobility impairment of morbidly obese patients. Defining novel costeffective protocols is important for reducing treatment costs. The study aimed to assess if Capacitive and Resistive Energy Transfer (TECAR) can reduce edema and the minimum number of sessions needed to observe volume reduction. Forty-eight severely obese subjects (age range: 46-78 years; BMI >40 kg/m2) with bilateral lower limb lymphedema were divided into three groups undergoing either manual lymphatic drainage, pressure therapy, or TECAR, in addition to a multidisciplinary rehabilitation program. They were compared to a control group composed by 12 women (age: 67.4 ± 8.9 years, BMI: 44.6 ± 4.1 Kg/m2) undergoing only the rehabilitation program. A handheld laser scanner 3D system was used for volume measurements. In addition, patients were evaluated with a Timed Up and Go (TUG) test and pain/heaviness of the lower limbs with a Visual Analog Scale (VAS). A significant volume reduction was observed after 6 sessions of TECAR: specifically, in the whole limb (PRE: 9.7+2.8 dm3; POST: 9.4+2.8 dm3; p<0.05) and in the thigh (PRE: 3.5+1.3 dm3; POST: 3.3+1.2 dm3; p<0.05). The TUG and VAS for pain showed a significant improvement in all groups. Our preliminary results suggest that TECAR can provide a relatively early reduction of lower limb edema with improvement of patients' function and pain.",2019,Our preliminary results suggest that TECAR can provide a relatively early reduction of lower limb edema with improvement of patients' function and pain.,"['Forty-eight severely obese subjects (age range: 46-78 years; BMI >40 kg/m2) with bilateral lower limb lymphedema', 'morbidly obese patients', '12 women (age: 67.4 ± 8.9 years, BMI: 44.6 ± 4.1 Kg/m2) undergoing only the rehabilitation program']","['TECAR', 'Capacitive and Resistive Energy Transfer (TECAR', 'manual lymphatic drainage, pressure therapy, or TECAR, in addition to a multidisciplinary rehabilitation program']","['volume reduction', 'Timed Up and Go (TUG) test and pain/heaviness of the lower limbs with a Visual Analog Scale (VAS']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0014274', 'cui_str': 'Energy transfer'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0145546,Our preliminary results suggest that TECAR can provide a relatively early reduction of lower limb edema with improvement of patients' function and pain.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cau', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cimolin', 'Affiliation': 'Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Aspesi', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Postiglione', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Todisco', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tacchini', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Darno', 'Affiliation': 'Freelance Physiatrist, Reggio Emilia, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Capodaglio', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Rehabilitation Unit and Research Lab in Biomechanics and Rehabilitation, Italy.'}]",Lymphology,[]
2468,31260374,Impact of  IFNL4  Genetic Variants on Sustained Virologic Response and Viremia in Hepatitis C Virus Genotype 3 Patients.,"Hepatitis C virus (HCV) genotype 3 is very prevalent in Europe and Asia and is associated with worst outcomes than other genotypes. Genetic factors have been associated with HCV infection; however, no extensive genome-wide study has been performed among HCV genotype 3 patients. In this study, using a large cohort of 1,759 patients infected with HCV genotype 3, we explore the role of genetic variants on the response to interferon (IFN) and direct-acting antiviral (DAA) regimens and viremia in a combined candidate gene and genome-wide analysis. We show that genetic variants within the IFN lambda 4 ( IFNL4 ) locus are the major factors associated with the studied traits, accordingly with observations in other HCV genotypes and with comparable effect sizes. In particular, the functional dinucleotide polymorphism rs368234815 was associated with IFN-based sustained virologic response (SVR) [odds ratio (OR) = 1.5,  P  = 2.3 × 10 -7 ], viremia (beta = -0.23,  P  = 8.8 × 10 -10 ), and also DAA-based SVR (OR = 1.7;  P  = 4.2 × 10 -4 ). Our results provide evidence for a role of genetic variants on HCV viremia and SVR, notably DAA-based, in patients infected with HCV genotype 3.",2019,Hepatitis C virus (HCV) genotype 3 is very prevalent in Europe and Asia and is associated with worst outcomes than other genotypes.,"['Hepatitis C Virus Genotype 3 Patients', '1,759 patients infected with HCV genotype 3']",['interferon (IFN) and direct-acting antiviral (DAA'],"['Sustained Virologic Response and Viremia', 'IFN-based sustained virologic response (SVR', 'viremia']","[{'cui': 'C3532921', 'cui_str': 'Hepatitis C virus genotype 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}]","[{'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",1759.0,0.0311598,Hepatitis C virus (HCV) genotype 3 is very prevalent in Europe and Asia and is associated with worst outcomes than other genotypes.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pedergnana', 'Affiliation': 'Wellcome Centre Human Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Irving', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Barnes', 'Affiliation': 'Nuffield Department of Medicine and the Oxford NIHR BRC, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McLauchlan', 'Affiliation': 'Centre for Virus Research, MRC-University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Chris C A', 'Initials': 'CCA', 'LastName': 'Spencer', 'Affiliation': 'Wellcome Centre Human Genetics, University of Oxford, Oxford, United Kingdom.'}]",Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research,['10.1089/jir.2019.0013']
2469,31302707,The relationship between eGFR slope and subsequent risk of vascular outcomes and all-cause mortality in type 2 diabetes: the ADVANCE-ON study.,"AIMS/HYPOTHESIS


Some studies have reported that annual change in eGFR (eGFR slope) is associated with the future risk of end-stage kidney disease, cardiovascular disease and death in general or chronic kidney disease cohorts. However, the benefits of using eGFR slopes for prediction of major clinical outcomes in diabetes are unclear.
METHODS


We used data from the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial and the ADVANCE Post-Trial Observational Study (ADVANCE-ON). After excluding the first 4 months during which an acute fall in eGFR was induced by the initiation of an ACE inhibitor and diuretic combination agent, eGFR slopes were estimated by linear mixed models, using three measurements of eGFR at 4, 12 and 24 months after randomisation over 20 months, and categorised according to quartiles. Cox regression models were used to evaluate adjusted HRs for the study's primary outcome, a composite of major renal events, major macrovascular events and all-cause mortality during the subsequent follow-up from 24 months after randomisation.
RESULTS


A total of 8,879 participants (80%) were included in this cohort. The mean age was 65.6 years (SD 6.3), the mean eGFR was 75 ml min -1  (1.73 m) -2  (SD 17) and the median urinary albumin/creatinine ratio was 14 μg/mg (interquartile range 7-38). The mean eGFR slope was -0.63 ml min -1  (1.73 m) -2  year -1  (SD 1.75). Over a median follow-up of 7.6 years following the 20-month eGFR slope ascertainment period, 2,221 participants (25%) met the primary outcome. An annual substantial decrease in eGFR (lowest 25%, <-1.63 ml min -1  [1.73 m] -2  year -1 ) was significantly associated with the subsequent risk of the primary outcome (HR 1.30 [95% CI 1.17, 1.43]) compared with a stable change in eGFR (middle 50%, -1.63 to 0.33). An annual substantial increase in eGFR (highest 25%, >0.33) had no significant association with the risk of the primary outcome (HR 0.96 [95% CI 0.86, 1.07]).
CONCLUSIONS/INTERPRETATION


Our study supports the utility of eGFR slope in type 2 diabetes as a surrogate endpoint for renal outcomes, as well as a prognostic factor for identifying individuals at high risk of cardiovascular disease and all-cause mortality.
TRIAL REGISTRY NUMBER


ClinicalTrials.gov registration no. NCT00145925 and no. NCT00949286.",2019,"An annual substantial decrease in eGFR (lowest 25%, <-1.63 ","['The mean age was 65.6\xa0years (SD 6.3), the mean eGFR was 75\xa0ml\xa0min -1  (1.73\xa0m) -2', 'type 2 diabetes', 'Diabetes and Vascular Disease', '8,879 participants (80%) were included in this cohort']",[],"['mean eGFR slope', 'median urinary albumin/creatinine ratio', 'eGFR', 'composite of major renal events, major macrovascular events and all-cause mortality']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",8879.0,0.219612,"An annual substantial decrease in eGFR (lowest 25%, <-1.63 ","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jun', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Ishikawa, Japan.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Diabetes Domain, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Hadjadj', 'Affiliation': 'Department of Endocrinology, Institut du Thorax, Inserm, CNRS, CHU Nantes, Nantes, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hamet', 'Affiliation': ""Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Department of Endocrinology, Hôpital Bichat-Claude Bernard, Université Paris, Paris, France.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Science, University College London and National Institute of Health Research UCL Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia. mark.woodward@georgeinstitute.ox.ac.uk.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Level 5, 1 King St, Newtown, NSW, 2042, Australia. VPerkovic@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-019-4948-4']
2470,31381878,Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.,"OBJECTIVE


To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy.
STUDY DESIGN


We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation.
RESULTS


Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of the 207 WC efficacy uses with evaluable postcoital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses.
CONCLUSIONS


When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies.
IMPLICATIONS


Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.",2019,"Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03).",['Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC'],[],['rate of semen exposure'],"[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C4517769', 'cui_str': '408'}]",[],"[{'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0769976,"Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03).","[{'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010. Electronic address: twalsh@essentialaccess.org.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Snead', 'Affiliation': 'Division of Reproductive Health, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333.'}, {'ForeName': 'Breione J', 'Initials': 'BJ', 'LastName': 'St Claire', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'CONRAD/EVMS, 1911 N. Fort Myer Drive, Ste. 900, Arlington, VA 22209.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Mauck', 'Affiliation': 'CONRAD/EVMS, 1911 N. Fort Myer Drive, Ste. 900, Arlington, VA 22209.'}, {'ForeName': 'Ron G', 'Initials': 'RG', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Obstetrics & Gynecology, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'University of Pennsylvania Medical Center, 3701 Market St., Ste. 800, Philadelphia, PA 19104.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Nelson', 'Affiliation': 'Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St., Cincinnati, OH 45219.'}, {'ForeName': 'Livia S', 'Initials': 'LS', 'LastName': 'Wan', 'Affiliation': 'Department of Obstetrics & Gynecology, New York University,462 First Ave., New York, NY 10016.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC 27244.'}]",Contraception,['10.1016/j.contraception.2019.07.143']
2471,31491428,Telomere length and physical performance among older people-The Helsinki Birth Cohort Study.,"Telomere length has been suggested a biomarker of aging and is associated with several chronic diseases. However, the association between telomere length and physical performance is not well known. Using both cross-sectional and longitudinal data, we studied 582 women and 453 men from the Helsinki Birth Cohort Study at two time-points; a baseline examination in 2001-2004 at a mean age of 61 years and a follow-up examination approximately 10 years later in 2011-2013. Telomere length was measured both at baseline and at follow-up using real-time quantitative polymerase chain reaction. Physical performance was evaluated only at follow-up using the Senior Fitness Test (SFT), which assesses strength, flexibility and endurance. In women, shorter telomere length at follow-up (p = 0.044) and greater telomere attrition during follow-up time (p = 0.022) were associated with poorer physical performance after adjusting for covariates (age at baseline, smoking status, body mass index at baseline, follow-up time and educational attainment). No similar associations were found for men. This indicates that, at least in women, telomere length could potentially be used as a biomarker for physical performance, however, more longitudinal studies are needed to confirm this association.",2019,"In women, shorter telomere length at follow-up (p = 0.044) and greater telomere attrition during follow-up time (p = 0.022) were associated with poorer physical performance after adjusting for covariates (age at baseline, smoking status, body mass index at baseline, follow-up time and educational attainment).","['582 women and 453 men from the Helsinki Birth Cohort Study at two time-points; a baseline examination in 2001-2004\u2009at a mean age of 61 years and a follow-up examination approximately 10 years later in 2011-2013', 'older people-The Helsinki Birth Cohort Study']",[],"['Telomere length and physical performance', 'telomere attrition', 'strength, flexibility and endurance', 'shorter telomere length', 'poorer physical performance', 'Physical performance', 'Telomere length']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1723187', 'cui_str': '3-(4-dimethylaminophenyl)-N-hydroxy-2-propenamide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",582.0,0.0219237,"In women, shorter telomere length at follow-up (p = 0.044) and greater telomere attrition during follow-up time (p = 0.022) were associated with poorer physical performance after adjusting for covariates (age at baseline, smoking status, body mass index at baseline, follow-up time and educational attainment).","[{'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Åström', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland. Electronic address: max.astrom@helsinki.fi.'}, {'ForeName': 'Mikaela B', 'Initials': 'MB', 'LastName': 'von Bonsdorff', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland; Faculty of Sport and Health Sciences and Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Mia-Maria', 'Initials': 'MM', 'LastName': 'Perälä', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland; Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Minna K', 'Initials': 'MK', 'LastName': 'Salonen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland; Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Faculty of Sport and Health Sciences and Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Kajantie', 'Affiliation': 'Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland; PEDEGO Research Unit, MRC Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland; Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Hospital for Children and Adolescents, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Simonen', 'Affiliation': 'Faculty of Arts, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pohjolainen', 'Affiliation': 'Age Institute, Helsinki, Finland.'}, {'ForeName': 'Markus J', 'Initials': 'MJ', 'LastName': 'Haapanen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Guzzardi', 'Affiliation': 'Institute of Clinical Physiology, National Research Council (CNR), Pisa, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Iozzo', 'Affiliation': 'Institute of Clinical Physiology, National Research Council (CNR), Pisa, Italy.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Johan G', 'Initials': 'JG', 'LastName': 'Eriksson', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Department of Public Health Solutions, Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland; Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), Singapore; Obstetrics & Gynecology, Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore.'}]",Mechanisms of ageing and development,['10.1016/j.mad.2019.111145']
2472,31654268,Biomarkers of leaky gut are related to inflammation and reduced physical function in older adults with cardiometabolic disease and mobility limitations.,"Intestinal barrier dysfunction is hypothesized to be a contributing determinant of two prominent characteristics of aging: inflammation and decline in physical function. A relationship between microbial translocation (MT), or their biomarkers (lipopolysaccharide binding protein-1 [LBP-1], soluble cluster of differentiation [sCD]-14), and physical function has been reported in healthy older adults, rats, and invertebrates. However, it is not known whether the existence of comorbidities, or clinical interventions intended to reduce comorbidities through weight loss or exercise, alters this connection. We measured inflammation, MT, and physical function in 288 overweight/obese older patients with cardiometabolic disease and self-reported mobility limitations who were enrolled in a weight loss and lifestyle intervention study. At baseline, inflammatory cytokines and LBP-1 were positively correlated after adjustment for age, gender, and body mass index. A higher LBP-1 was significantly associated with poorer physical functional after covariate adjustment. Further, even when IL-6 levels were included in the models, 400-m walk time (p = 0.003), short physical performance battery (p = 0.07), and IL-8 (p < 0.001) remained positively associated with LBP-1. Lifestyle interventions improved body mass and some functional measures; however, MT and inflammation were unchanged. MT is reliably related to inflammation, and to poorer physical function in older adults with comorbid conditions. Intestinal barrier function did not appear to improve as a result of intervention assignment, suggesting alternative strategies are needed to target this pro-inflammatory pathway in aging.",2019,"At baseline, inflammatory cytokines and LBP-1 were positively correlated after adjustment for age, gender, and body mass index.","['288 overweight/obese older patients with cardiometabolic disease and self-reported mobility limitations who were enrolled in a weight loss and lifestyle intervention study', 'older adults with cardiometabolic disease and mobility limitations', 'healthy older adults, rats, and invertebrates', 'older adults with comorbid conditions']",[],"['IL-8', 'MT and inflammation', 'short physical performance battery', 'IL-6 levels', 'LBP-1], soluble cluster of differentiation [sCD]-14), and physical function', 'inflammatory cytokines and LBP-1', 'inflammation, MT, and physical function', 'Intestinal barrier function']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}]",[],"[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",288.0,0.0239576,"At baseline, inflammatory cytokines and LBP-1 were positively correlated after adjustment for age, gender, and body mass index.","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Pathology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157-1009, USA. kkavanag@wakehealth.edu.'}, {'ForeName': 'Fang-Chi', 'Initials': 'FC', 'LastName': 'Hsu', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ashley T', 'Initials': 'AT', 'LastName': 'Davis', 'Affiliation': 'Department of Pathology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157-1009, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': ""Sticht Center on Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, NC, USA.""}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Sunghye', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Section of Rheumatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",GeroScience,['10.1007/s11357-019-00112-z']
2473,31724891,"Deep learning-based automatic blood pressure measurement: evaluation of the effect of deep breathing, talking and arm movement.","Objectives:  It is clinically important to evaluate the performance of a newly developed blood pressure (BP) measurement method under different measurement conditions. This study aims to evaluate the performance of using deep learning-based method to measure BPs and BP change under non-resting conditions. Materials and methods:  Forty healthy subjects were studied. Systolic and diastolic BPs (SBPs and DBPs) were measured under four conditions using deep learning and manual auscultatory method. The agreement between BPs determined by the two methods were analysed under different conditions. The performance of using deep learning-based method to measure BP changes was finally evaluated. Results:  There were no significant BPs differences between two methods under all measurement conditions (all  p  > .1). SBP and DBP measured by deep learning method changed significantly in comparison with the resting condition: decreased by 2.3 and 4.2 mmHg with deeper breathing (both  p  < .05), increased by 3.6 and 6.4 mmHg with talking, and increased by 5.9 and 5.8 mmHg with arm movement (all  p  < .05). There were no significant differences in BP changes measured by two methods (all  p  > .4, except for SBP change with deeper breathing). Conclusion:  This study demonstrated that the deep learning method could achieve accurate BP measurement under both resting and non-resting conditions.Key messagesAccurate and reliable blood pressure measurement is clinically important. We evaluated the performance of our developed deep learning-based blood pressure measurement method under resting and non-resting measurement conditions.The deep learning-based method could achieve accurate BP measurement under both resting and non-resting measurement conditions.",2019,"There were no significant differences in BP changes measured by two methods (all  p  > .4, except for SBP change with deeper breathing).",['Forty healthy subjects'],"['deep learning-based method to measure BPs and BP change under non-resting conditions', 'Deep learning-based automatic blood pressure measurement', 'deep learning-based blood pressure measurement method under resting and non-resting measurement conditions']","['Systolic and diastolic BPs (SBPs and DBPs', 'SBP and DBP', 'accurate BP measurement', 'BP changes', 'SBP change with deeper breathing']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0058453', 'cui_str': 'discoidin-binding polysaccharide'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",40.0,0.0188236,"There were no significant differences in BP changes measured by two methods (all  p  > .4, except for SBP change with deeper breathing).","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Electrical and Electronic Engineering, Southern University of Science and Technology, Shenzhen, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Pu', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qijun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'College of Computer Science, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dingchang', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Research Centre of Intelligent Healthcare, Faculty of Health and Life Science, Coventry University, Coventry, UK.'}]",Annals of medicine,['10.1080/07853890.2019.1694170']
2474,32650818,Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The aim of this trial is to identify the effect of ambulatory treatment in early COVID-19 disease with hydroxychloroquine on the rate of hospitalization or death in older patients above the age of 64.
TRIAL DESIGN


Parallel, 2:1 randomization, double blind, placebo-controlled, multi-center trial.
PARTICIPANTS


Male and female patients above the age of 64 (i.e. ≥65 years of age) with COVID-19 diagnosis confirmed by SARS-CoV2 positive throat swab (PCR). Patients can only be included within 3 days of symptom onset in ambulatory care if they consent to the study procedure and are able to adhere to the study visit schedule and protocol requirements (including telephone visits concerning symptoms and side effects). Severity of disease at inclusion is mild to moderate defined as not requiring hospital admission: SpO2 >94%, respiratory rate <20, mental state alert, no signs of septic shock. Cardiac risk is minimised by requiring a Tisdale score ≤ 6. Patients are recruited in the two german cities of Ulm and Tübingen in various ambulatory care settings.
INTERVENTION AND COMPARATOR


Each patient will be given a first dose of 600 mg Hydroxychloroquine or the equivalent number of placebo capsules (3 capsules) at the day of inclusion. From the 2 nd  day on, each patient will get 200 mg or the equivalent number of placebo capsules twice a day (400mg/day) until day 7 (6 more does of 400 mg); a cumulative dose of 3 g.
MAIN OUTCOMES


Rate of hospitalization or death at day 7 after study inclusion RANDOMISATION: All consenting adult patients having confirmed COVID-19 are randomly and blindly allocated in a 2:1 ratio to either IMP or placebo. The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center. This list is provided for packaging to the pharmaceutical unit which is providing encapsulated placebo and IMP. Only the pharmaceutical unit is aware of group allocation according to the randomization list.
BLINDING (MASKING)


Patients and investigators, as well as treating physicians are blinded to the treatment- allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


In the first stage of an adaptive design 120 patients in a 2:1 ration: 72 Verum and 36 Placebo, plus an increase for 10% drop outs. After interim analysis, the total sample size will be calculated based on the effect seen in the first stage. Total sample size is estimated approximately n = 300-400 patients.
TRIAL STATUS


Protocol version number: V3, 19.05.2020 Recruitment not yet started but is anticipated to begin by June 2020 and be complete by December 2020 TRIAL REGISTRATION: ClinicalTrials.gov: NCT04351516 , date: 17 April 2020 EudraCT: 2020-001482-37, date: 30 March 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center.,"['Male and female patients above the age of 64 (i.e. ≥65 years of age) with COVID-19 diagnosis confirmed by SARS-CoV2 positive throat swab (PCR', 'Patients are recruited in the two german cities of Ulm and Tübingen in various ambulatory care settings', 'All consenting adult patients having confirmed COVID-19', 'older patients above the age of 64', 'Total sample size is estimated approximately n = 300-400 patients', 'older patients with COVID19']","['Placebo', 'hydroxychloroquine', 'IMP or placebo', 'Hydroxychloroquine', 'COVID 65 plus - Hydroxychloroquine versus placebo', 'placebo']","['rate of hospitalization or death', 'Rate of hospitalization or death']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0021533', 'cui_str': 'Inosine monophosphate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.656907,The biostatistical center produced a randomization list (block randomization) with varying block length and stratified for the study center.,"[{'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Göpel', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany. siri.goepel@med.uni-tuebingen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bethge', 'Affiliation': 'Department Internal Medicine 2, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biostatistics, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kreth', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Iftner', 'Affiliation': 'Department of Virology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Department of General Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Döbele', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institute for Tropical Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kremsner', 'Affiliation': 'Institute for Tropical Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Medical Clinic 1, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Medical Clinic 1, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nisar', 'Initials': 'N', 'LastName': 'Malek', 'Affiliation': 'Department of Internal Medicine 1, University Hospital Tübingen, Tübingen, Germany.'}]",Trials,['10.1186/s13063-020-04556-z']
2475,32650886,Impact of a pain management program on nurses' knowledge and attitude toward pain in United Arab Emirates: Experimental-four Solomon group design.,"BACKGROUND


Lack of knowledge about pain is a common barrier to effective pain management. Educational pain management programs directed to health care professionals can improve knowledge and attitudes about pain. However, changing practice is more challenging, but can be achieved with more targeted educational interventions within the clinical setting.
OBJECTIVES


The main objective of this study was to examine which of four separate pain management educational designs improved nurses' knowledge and attitudes toward pain over time. Secondary objectives were to compare and contrast nurse's knowledge and attitudes toward pain before and after the educational intervention.
DESIGN


This randomized controlled trial using a four Solomon group design.
SETTING


This study took place in Dubai Hospital, Dubai Health Authority, in United Arab Emirates between January 2019-April 2019.
PARTICIPANTS


The sample consisted of 200 registered nurses who were randomly selected and assigned into four separate educational groups. Participants had at least one year of experience in Dubai hospital prior to data collection.
RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01). One-way ANOVA revealed significant post-test score differences between groups p < 0.001. A repeated measures ANOVA with a Greenhouse-Geisser correction determined that mean scores over three months was not statistically significant. Indicating that the level of knowledge did not change over time within any of the groups.
CONCLUSION AND RECOMMENDATIONS


The most important findings were the relatively low pre-test knowledge scores among staff nurses, and the significant improvement in knowledge for most test items following the educational intervention. Moreover, the level of knowledge and attitudes were maintained over three months. The pain management program proved to be effective in improving nurses' pain knowledge, attitudes, and assessment practices. Nurses in the experimental group increased their pain score significantly after the pain management program. Registration number: NETUBR.",2020,"RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01).","['Participants had at least one year of experience in Dubai hospital prior to data collection', 'Dubai Hospital, Dubai Health Authority, in United Arab Emirates between January 2019-April 2019', 'The sample consisted of 200 registered nurses who were randomly selected and assigned into four separate educational groups']",['pain management program'],"[""nurses' knowledge and attitude toward pain"", ""contrast nurse's knowledge and attitudes toward pain"", 'pain score', 'level of knowledge and attitudes', ""nurses' knowledge and attitudes toward pain over time""]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",200.0,0.0258756,"RESULTS


paired t-test has shown the experimental group scored significantly higher than the control group (p < 0.01).","[{'ForeName': 'Nezar Ahmed', 'Initials': 'NA', 'LastName': 'Salim', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA. Electronic address: Nezar_dubai30@yahoo.com.'}, {'ForeName': 'Mohammed Ghassan', 'Initials': 'MG', 'LastName': 'Tuffaha', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Brant', 'Affiliation': 'Dubai Health Authority, Education Department, Dubai Hospital, Dubai, United Arab Emirates; Amana Health Care Medical and Rehabilitation Hospital, Abu Dhabi, United Arab Emirates; Collaborative Science and Innovation, Clinical Nurse Specialist and Nurse Scientist, Billings Clinic, MT, USA.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151314']
2476,32650887,Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors.,"BACKGROUND


Post-ICU rehabilitation is a challenging clinical issue for patients discharged from an Intensive Care Unit (""ICU survivors""). Our exercise to rhythmic music intervention was designed to allow ICU survivors to self-manage their exercise by following a personalized, recorded exercise playlist.
AIM


Our study reports the feasibility and acceptability of an innovative music intervention among ICU survivors enrolled in a randomized controlled pilot study.
METHODS


ICU survivors, admitted in ICU for at least 5 days and cognitively intact, were randomly assigned to an exercise to rhythmic music group (n = 10) or an active control group (n = 10). Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability. Participants in the control group were provided a brochure with exercise instructions. After 5 days or at hospital discharge, participants completed an 8-item acceptability questionnaire and were interviewed. Content analysis was conducted.
RESULTS


18 Participants were included for final analysis. Participants were 61.8 ± 14.7 years old, predominantly male (66.7%), and Caucasian (55.6%). Results demonstrated feasibility, as the study team was able to meet the enrollment goal of 5-6 participants per month. Three themes related to general, physical, and psychosocial benefits were identified. Based on positive feedback, the exercise to rhythmic music intervention was deemed acceptable.
CONCLUSION


The exercise to rhythmic music intervention was feasible and acceptable, suggesting that clinical trials with larger sample sizes should investigate the effects of the intervention on outcomes among ICU survivors.",2020,Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability.,"['ICU survivors, admitted in ICU for at least 5\xa0days and cognitively intact', '14.7\xa0years old, predominantly male (66.7%), and Caucasian (55.6', 'ICU survivors', 'patients discharged from an Intensive Care Unit (""ICU survivors', '18 Participants were included for final analysis', 'Participants were 61.8\xa0±']","['brochure with exercise instructions', 'rhythmic music intervention', 'self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability', 'self-managed exercise to rhythmic music intervention', 'exercise to rhythmic music group (n\xa0=\xa010) or an active control group', 'innovative music intervention']","['8-item acceptability questionnaire', 'Feasibility and acceptability']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",18.0,0.0639096,Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability.,"[{'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America. Electronic address: zxl667@miami.edu.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America.'}, {'ForeName': 'Tanira B D', 'Initials': 'TBD', 'LastName': 'Ferreira', 'Affiliation': 'University of Miami Hospital & Clinics, Department of Medicine, Division of Pulmonary Disease and Critical Care, Miami, FL, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clochesy', 'Affiliation': 'University of Miami, School of Nursing and Health Studies, United States of America.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Yip', 'Affiliation': 'University of Miami, Frost School of Music, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Sena Moore', 'Affiliation': 'University of Miami, Frost School of Music, United States of America.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kip', 'Affiliation': 'University of South Florida, College of Public Health, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151315']
2477,32650961,Intratympanic steroid injection for sudden sensorineural hearing loss: Impact of injection interval on therapeutic efficacy.,"OBJECTIVE


To compare the effect of injection time intervals of intratympanic (IT) dexamethasone (DEX) in patients with idiopathic sudden sensorineural hearing loss (ISSNHL).
METHODS


Seventy-five adults with ISSNHL were grouped into four groups according to the IT DEX interval. In addition to concurrent oral steroid medication for two weeks, patients received IT DEX injections every 1, 2, 3, and four days, respectively. (Group 1, Group 2, Group 3, and Group 4). We evaluated the treatment outcomes according to modified criteria from ""Clinical Practice Guideline: Sudden Hearing Loss"" of the American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) to justify treatment success.
RESULTS


There were no significant differences in demographic and baseline audiometric data. The mean of pure tone audiometry (PTA) and speech discrimination score (SDSs) were significantly improved after oral steroid and IT DEX treatment in all four groups. Group 1 showed significantly higher improvement than Group 4 in PTA after treatment. There was a significantly higher complete recovery (CR) rate in Group 1 than Group 4.
CONCLUSION


We found a statistically significant difference in the complete hearing recovery rate and audiometric results (PTA) between the group with a daily interval of injections and the group with a four-day time interval. Therefore, daily time intervals in intratympanic steroid injection may be considered as an option for better improvement of hearing in patients with ISSNHL.",2020,We found a statistically significant difference in the complete hearing recovery rate and audiometric results (PTA) between the group with a daily interval of injections and the group with a four-day time interval.,"['sudden sensorineural hearing loss', 'Seventy-five adults with ISSNHL', 'patients with ISSNHL', 'patients with idiopathic sudden sensorineural hearing loss (ISSNHL']","['oral steroid and IT DEX', 'intratympanic (IT) dexamethasone (DEX', 'IT DEX', 'Intratympanic steroid injection']","['complete recovery (CR) rate', 'complete hearing recovery rate and audiometric results (PTA', 'demographic and baseline audiometric data', 'mean of pure tone audiometry (PTA) and speech discrimination score (SDSs']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}]",75.0,0.0374949,We found a statistically significant difference in the complete hearing recovery rate and audiometric results (PTA) between the group with a daily interval of injections and the group with a four-day time interval.,"[{'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Kwak', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Department of Otorhinolaryngology, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Chan Ju', 'Initials': 'CJ', 'LastName': 'Yang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun Joon', 'Initials': 'HJ', 'LastName': 'Shim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Eulji University School of Medicine, Eulji Medical Center, Seoul, Korea.'}, {'ForeName': 'Chan Il', 'Initials': 'CI', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong Yang', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Otolaryngology, National Police Hospital, Seoul, Korea.'}, {'ForeName': 'Il Woo', 'Initials': 'IW', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, College of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Sung Wook', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery, College of Medicine, Dong-A University, Busan, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lim', 'Affiliation': 'Department of Otolaryngology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Joong Keun', 'Initials': 'JK', 'LastName': 'Kwon', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Suk', 'Initials': 'YS', 'LastName': 'An', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Bundang Jesaeng General Hospital, Daejin Medical Center, Seongnam, Korea.'}, {'ForeName': 'Kyu-Yup', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: jwchung@amc.seoul.kr.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.06.009']
2478,32651013,Randomized Study of Delayed Cord Clamping of 30 to 60 Seconds in the Larger Infant Born Preterm.,"In a randomized study of infants born preterm (gestational age 28-34 6/7 weeks), we evaluated delayed cord clamping for 30 (n = 50) vs 60 (n = 55) seconds. The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds. There were no differences in secondary outcomes and no adverse consequences between groups. These findings should serve as a stimulus to many centers that are reluctant to implement delayed cord clamping in this targeted larger premature population.",2020,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","['Larger Infant Born Preterm', 'infants born preterm (gestational age 28-34 6/7\xa0weeks), we evaluated delayed cord clamping for 30 (n\xa0=\xa050) vs 60 (n\xa0=\xa055) seconds']",['Delayed Cord Clamping'],"['adverse consequences', 'initial hematocrit']","[{'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]",,0.0611567,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Perretta', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Spaight', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Yap', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Perlman', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY. Electronic address: jmp2007@med.cornell.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.058']
2479,32651028,Colonoscopic techniques in polyp detection: An Egyptian study.,"INTRODUCTION AND AIMS


The polyp detection rate (PDR) is defined as the percentage of colonoscopies in which one or more polyps are detected, and has been shown to be highly correlated with the adenoma detection rate. The aim of the present study was to evaluate the PDR at the Endoscopy Unit of the Kasr Al-Ainy Hospital, Cairo University, Egypt, through the i-SCAN, Endocuff, and underwater colonoscopy techniques.
MATERIALS AND METHODS


The study was conducted on 100 Egyptian subjects over 50 years of age. Their polyp detection rate was measured through 4 different colonoscopic techniques. An equal number of patients were divided into 4 groups: i-SCAN, Endocuff, underwater colonoscopy, and controls. The control group was examined using standard white light colonoscopy. The colonoscopy evaluation included the type of agent utilized for bowel preparation, preparation grade, and colonoscopy withdrawal time.
RESULTS


The general PDR was 48%. The i-SCAN technique had the highest rate (56%), followed by the underwater (52%) and the Endocuff (48%) techniques.
CONCLUSION


The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.",2020,"The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.",['100 Egyptian subjects over 50 years of age'],"['standard white light colonoscopy', 'Colonoscopic techniques']","['polyp detection rate', 'polyp detection rate (PDR']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",100.0,0.0190728,"The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelbary', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shehab', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'ElGarhy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Menesy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marzaban', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto. Electronic address: egymarz@yahoo.com.'}]",Revista de gastroenterologia de Mexico,['10.1016/j.rgmx.2020.02.004']
2480,32651030,"Effects of an integrative approach to bipolar disorders combining psychoeducation, mindfulness-based cognitive therapy and functional remediation: Study protocol for a randomized controlled trial.","INTRODUCTION


Bipolar disorder is related to a high level of personal, familial, social and economic burden. There is a need for feasible adjunctive psychological interventions easy to implement in clinical practice in order to enhance aspects that medication alone cannot achieve. This study aims to evaluate the impact of a 12-session adjunctive integrative program designed for patients with bipolar disorder.
METHODS


This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona. All participants will be randomly assigned to two arms. All the patients will receive treatment as usual (TAU) but in addition the experimental group will receive an integrative approach consisting of 12-sessions of 90min each in which contents of psychoeducation for patients have been combined with a session for family members, and complemented with aspects related to health promotion, mindfulness training, and strategies for cognitive and functional enhancement. The whole sample will be assessed at baseline, after completion (3-months) and at 12 months from baseline regarding demographic and clinical variables, psychosocial and cognitive functioning, wellbeing and quality of life. The primary outcome measure will be improvement in psychosocial functioning.
CONCLUSIONS


If the integrative approach is effective, it would allow clinicians to cover different areas that may be affected by bipolar disorder, by means of a brief intervention that can therefore be easily generalized to clinical practice.
TRIAL REGISTRATION


NCT04031560. Date registered July 24, 2019.",2020,"This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona.","['132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona', 'patients with bipolar disorder']","['integrative approach to bipolar disorders combining psychoeducation, mindfulness-based cognitive therapy']","['psychosocial functioning', 'demographic and clinical variables, psychosocial and cognitive functioning, wellbeing and quality of life']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",132.0,0.145927,"This is a single-blind prospective, randomized controlled trial involving a total of 132 outpatients with bipolar disorder who will be recruited from the Hospital Clinic of Barcelona.","[{'ForeName': 'Èlia', 'Initials': 'È', 'LastName': 'Valls', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sánchez-Moreno', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain. Electronic address: JSANCHE1@clinic.cat.'}, {'ForeName': 'C Mar', 'Initials': 'CM', 'LastName': 'Bonnín', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Brisa', 'Initials': 'B', 'LastName': 'Solé', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Prime-Tous', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Torres', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Brat', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gavin', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Morilla', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Montejo', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jiménez', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Varo', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Torrent', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hidalgo-Mazzei', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Martínez-Arán', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain. Electronic address: AMARTIAR@clinic.cat.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Reinares', 'Affiliation': 'Barcelona Bipolar Disorders and Depressive Unit, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clínic of Barcelona, Villarroel, 170, 08036 Barcelona, Catalonia, Spain.'}]",Revista de psiquiatria y salud mental,['10.1016/j.rpsm.2020.05.005']
2481,32651046,Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning in diffuse large B-cell lymphoma: Post-hoc analysis from the PETAL trial' [Eur J Canc 124 (January 2020) 25-36].,,2020,,['diffuse large B-cell lymphoma'],"[""Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning""]",[],"[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",[],,0.0252584,,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: christine.schmitz@uk-essen.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Müller', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Hanoun', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boellaard', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Brinkmann', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rekowski', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.019']
2482,32651047,Do peer social relationships mediate the harmful effects of a housing mobility experiment on boys' risky behaviors?,"PURPOSE


The purpose of this study was to understand why a housing mobility experiment caused harmful effects on adolescent boys' risky behaviors.
METHODS


Moving to Opportunity (MTO) (1994-2010) randomly assigned volunteer families to a treatment group receiving a Section 8 rental voucher or a public housing control group. Our outcome was a global risky behavior index (RBI; measured in 2002, n = 750 boys) measuring the fraction of 10 items the youth engaged in, 6 measuring past 30-day substance use and 4 measuring recent risky sexual behavior. Potential mediators (measured in 2002) included peer social relationships (e.g., peer drug use, peer gang membership).
RESULTS


The voucher treatment main effect on boys' RBI was harmful (B (SE) = 0.05 (0.02), 95% CI 0.01, 0.08), and treatment marginally increased having friends who used drugs compared to controls (B (SE) = 0.67 (0.23), 95% CI 0.22, 1.12). Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
CONCLUSIONS


Incorporating additional supports into housing voucher programs may help support teenage boys who experience disruptions to their social networks, to buffer potential adverse consequences of residential mobility.",2020,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[""adolescent boys' risky behaviors""]",['Section 8 rental voucher or a public housing control group'],"['total treatment effect', 'risky sexual behavior', 'global risky behavior index (RBI', 'peer social relationships (e.g., peer drug use, peer gang membership']","[{'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",,0.0719186,"Having friends who used drugs marginally mediated the MTO treatment effect on RBI (indirect effect: B (SE) = 0.02(.01), 95% CI -0.002, 0.04), reducing the total treatment effect by 39%.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Schmidt', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis. Electronic address: schmidtn@umn.edu.'}, {'ForeName': 'Naomi Harada', 'Initials': 'NH', 'LastName': 'Thyden', 'Affiliation': 'Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Osypuk', 'Affiliation': 'Minnesota Population Center, University of Minnesota, Minneapolis; Department of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis.'}]",Annals of epidemiology,['10.1016/j.annepidem.2020.05.007']
2483,32651051,Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes.,"INTRODUCTION


Electroconvulsive therapy (ECT) pulse amplitude, which determines the induced electric field magnitude in the brain, is currently set at 800-900 milliamperes (mA) on modern ECT devices without any clinical or scientific rationale. The present study assessed differences in depression and cognitive outcomes for three different pulse amplitudes during an acute ECT series. We hypothesized that the lower amplitudes would maintain the antidepressant efficacy of the standard treatment and reduce the risk of neurocognitive impairment.
METHODS


This double-blind investigation randomized subjects to three treatment arms: 600, 700, and 800 mA (active comparator). Clinical, cognitive, and imaging assessments were conducted pre-, mid- and post-ECT. Subjects had a diagnosis of major depressive disorder, age range between 50 and 80 years, and met clinical indication for ECT.
RESULTS


The 700 and 800 mA arms had improvement in depression outcomes relative to the 600 mA arm. The amplitude groups showed no differences in the primary cognitive outcome variable, the Hopkins Verbal Learning Test-Revised (HVLT-R) retention raw score. However, secondary cognitive outcomes such as the Delis Kaplan Executive Function System Letter and Category Fluency measures demonstrated cognitive impairment in the 800 mA arm.
DISCUSSION


The results demonstrated a dissociation of depression (higher amplitudes better) and cognitive (lower amplitudes better) related outcomes. Future work is warranted to elucidate the relationship between amplitude, electric field, neuroplasticity, and clinical outcomes.",2020,"The amplitude groups showed no differences in the primary cognitive outcome variable, the Hopkins Verbal Learning Test-Revised (HVLT-R) retention raw score.","['Subjects had a diagnosis of major depressive disorder, age range between 50 and 80 years, and met clinical indication for ECT']",['Electroconvulsive therapy (ECT) pulse amplitude'],"['depression outcomes', 'Delis Kaplan Executive Function System Letter and Category Fluency measures demonstrated cognitive impairment', 'depression and cognitive outcomes', 'Hopkins Verbal Learning Test-Revised (HVLT-R) retention raw score', 'dissociation of depression']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}]",,0.0723063,"The amplitude groups showed no differences in the primary cognitive outcome variable, the Hopkins Verbal Learning Test-Revised (HVLT-R) retention raw score.","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Abbott', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM. Electronic address: cabbott@salud.unm.edu.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Quinn', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Enstin', 'Initials': 'E', 'LastName': 'Ye', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Sulaiman', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Lloyd', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Upston', 'Affiliation': 'Department of Psychiatry (CCA, DQ, JM, EY, SI, ML, TRJ, JU), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Zhi De', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit (ZDD), Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD; Division of Brain Stimulation and Neurophysiology (SMM), Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Erhardt', 'Affiliation': 'Department of Mathematics and Statistics (EE), University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Division of Psychology, Department of Psychiatry (SMM), UT Southwestern Medical Center, Dallas, TX; Division of Brain Stimulation and Neurophysiology (SMM), Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.06.008']
2484,32651093,Sleep leadership in the army: A group randomized trial.,"OBJECTIVES


Examine impact of training military leaders in sleep health on leaders and unit members.
DESIGN


Following a baseline survey, two-person platoon leadership teams were randomly assigned by company to a training or waitlist control condition. After training, leadership teams completed a post-training survey. Six weeks later, leaders and unit members completed a final survey.
SETTING


Classroom-style areas on a US military base.
PARTICIPANTS


US soldiers (76 leaders and 448 unit members) from 39 platoons across 14 companies in a brigade combat team.
INTERVENTION


One-hour training in sleep leadership.
MEASUREMENTS


Leaders were surveyed about sleep knowledge, sleep attitudes, sleep training, sleep quantity, sleep quality and sleep problems. Unit members were surveyed about sleep leadership behaviors, sleep hours, sleep quality and sleep problems.
RESULTS


Leaders rated the training highly and most knowledge and some attitudes about sleep improved from the baseline to post-training survey. Fewer leaders in the training condition reported sleep problems at follow-up than those in the waitlist control condition; there were no differences in sleep hours or sleep quality. More unit members with leaders in the training condition reported that their leaders engaged in sleep leadership behaviors at least sometimes and reported sleeping at least 7 hours/24 hours period than did unit members in the waitlist control condition; sleep quality and sleep problems did not differ by condition.
CONCLUSIONS


Results suggest a simple training intervention targeting leaders may be able to shift sleep health and the cultural perspective on sleep across an organization.",2020,Fewer leaders in the training condition reported sleep problems at follow-up than those in the waitlist control condition; there were no differences in sleep hours or sleep quality.,"['Following a baseline survey, two-person platoon leadership teams', 'US soldiers (76 leaders and 448 unit members) from 39 platoons across 14 companies in a brigade combat team', 'training military leaders in sleep health on leaders and unit members', 'Classroom-style areas on a US military base']",['company to a training or waitlist control condition'],"['sleep knowledge, sleep attitudes, sleep training, sleep quantity, sleep quality and sleep problems', 'sleep hours or sleep quality', 'sleep problems', 'sleep leadership behaviors', 'Sleep leadership', 'sleep leadership behaviors, sleep hours, sleep quality and sleep problems', 'sleep quality and sleep problems']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2936504', 'cui_str': 'Military Bases'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0183945,Fewer leaders in the training condition reported sleep problems at follow-up than those in the waitlist control condition; there were no differences in sleep hours or sleep quality.,"[{'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Adler', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, USA. Electronic address: amy.b.adler.civ@mail.mil.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Bliese', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, USA; University of South Carolina, Darla Moore School of Business, 1014 Greene St., Columbia, SC, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'LoPresti', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'McDonald', 'Affiliation': 'United States Army Medical Research Directorate-West, 9933 West Johnson St., Joint Base Lewis McChord, WA, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Merrill', 'Affiliation': 'United States Army Medical Research Directorate-West, 9933 West Johnson St., Joint Base Lewis McChord, WA, USA.'}]",Sleep health,['10.1016/j.sleh.2020.06.001']
2485,32642151,"Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial.","Background


This trial aimed to investigate the treatment response, survival profiles and treatment-related adverse events (AEs) of apatinib plus docetaxel in advanced non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR).
Methods


Thirty advanced non-squamous NSCLC patients with wild-type EGFR were recruited in this multi-center, phase II trial. All patients received apatinib (orally 500 mg, once daily until disease progression, intolerable toxicity, or death) plus docetaxel (intravenously 60 mg/m 2  at day 1 every 3 weeks for 4-6 cycles). The treatment response, progression-free survival (PFS), overall survival (OS) and treatment-related AEs were evaluated.
Results


One patient lacked response and survival assessment due to early lost follow-up, therefore, 29 patients were included in response and survival analysis. There was no (0.0%) patient achieved complete remission, 8 (27.6%) patients achieved partial remission, 20 (69%) patients with stable disease, and 1 (3.4%) patient with progressive disease, resulting in objective response rate and disease control rate of 27.6% and 96.6%, respectively. According to the survival data, median PFS was 5.3 months (95% CI: 3.6-6.9 months) and median OS was 9.6 months (95% CI: 6.33-12.9 months). For safety, totally 30 patients were included in the analysis. Common non-hematologic AEs included hypertension (66.7%), hand-foot syndrome (40.0%), proteinuria (36.7%); common hematologic AEs included leukopenia (26.7%), thrombocytopenia (23.3%), neutropenia (16.7%). Notably, majority of AEs were at grade 1-2, and the overall AEs were tolerable.
Conclusions


Apatinib plus docetaxel is an effective and tolerable treatment option for advanced non-squamous NSCLC with wild-type EGFR.",2020,"According to the survival data, median PFS was 5.3 months (95% CI: 3.6-6.9 months) and median OS was 9.6 months (95% CI: 6.33-12.9 months).","['Thirty advanced non-squamous NSCLC patients with wild-type EGFR', 'advanced non-squamous NSCLC with wild-type EGFR', 'advanced non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR', '30 patients were included in the analysis', 'treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR']","['apatinib plus docetaxel', 'docetaxel', 'apatinib and docetaxel', 'apatinib (orally 500 mg, once daily until disease progression, intolerable toxicity, or death) plus docetaxel']","['response and survival assessment', 'complete remission', 'neutropenia', 'median OS', 'partial remission', 'thrombocytopenia', 'proteinuria', 'leukopenia', 'objective response rate and disease control rate', 'treatment response, progression-free survival (PFS), overall survival (OS) and treatment-related AEs', 'survival data, median PFS', 'hand-foot syndrome', 'hypertension']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",30.0,0.193481,"According to the survival data, median PFS was 5.3 months (95% CI: 3.6-6.9 months) and median OS was 9.6 months (95% CI: 6.33-12.9 months).","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing 210002, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Department of Respiratory Medicine, Nanjing Drum Tower Hospital, Nanjing University School of Medicine, Nanjing 210008, China.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, China.'}, {'ForeName': 'Meiqi', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing Medical University, Nanjing 210009, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.03.54']
2486,32642278,Erratum to laparoscopic needle catheter jejunostomy by using a double semipurse string suture method in minimally invasive Ivor Lewis esophagectomy.,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,2020,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,['minimally invasive Ivor Lewis esophagectomy'],['laparoscopic needle catheter jejunostomy'],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0491233', 'cui_str': 'Needle catheter'}, {'cui': 'C0022377', 'cui_str': 'Creation of jejunostomy'}]",[],,0.0288503,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,"[{'ForeName': 'Xuyang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid and Breast Surgery, Lishui Hospital of Zhejiang University, Lishui Municipal Central Hospital, Lishui 323000, China.'}, {'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Tianwei', 'Initials': 'T', 'LastName': 'Zhan', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}]",Journal of thoracic disease,['10.21037/jtd-2020-53']
2487,32642394,Comparing Stimulus Equivalence-Based Instruction to a Video Lecture to Increase Religious Literacy in Middle-School Children.,"Being familiar with world religions and their diverse practices is referred to as  religious literacy . The present study compared the effects of stimulus equivalence-based instruction (EBI) and video lecture (VL) to increase religious literacy in middle-school students; 10 participants were assigned to either the EBI or the VL group. Participants in the EBI group were taught five 6-member equivalence classes using match-to-sample (MTS) software on a computer. Within each class of (1) Judaism, (2) Islam, (3) Christianity, (4) Hinduism, and (5) Buddhism, the visual stimulus members were (A) name of the religion, (B) major religious symbol, (C) sacred text, (D) notable religious figure, (E) name of religious service leader, and (F) notable celebrated holiday. The VL participants were given an opportunity to complete a fill-in written worksheet while viewing a video lecture about the 5 religions using the same stimuli as the EBI group. Participant responding in each group was compared across worksheet, oral, and MTS pretests and posttests. The results showed that 5 of 5 participants in the EBI group formed equivalence classes but only 1of 5 did so in the VL group. Class-consistent responding generalized to oral vignettes to a greater degree for the EBI participants than for the VL participants. In addition, at an approximately 2-week follow-up, EBI participants maintained class-consistent responding to a greater degree than VL participants did. Duration measures showed that even though EBI was more effective, EBI training did require more time than the VL did. Although not explicitly programmed for, social distance survey scores showed that participants improved equally in their ratings of the acceptability of people from other faiths following training, regardless of training type. Thus, EBI may be an effective method to teach schoolchildren about religious literacy.",2020,Class-consistent responding generalized to oral vignettes to a greater degree for the EBI participants than for the VL participants.,"['middle-school students; 10 participants', 'Middle-School Children']","['stimulus equivalence-based instruction (EBI) and video lecture (VL', 'Stimulus Equivalence-Based Instruction to a Video Lecture']","['social distance survey scores', 'religious literacy']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",10.0,0.0174381,Class-consistent responding generalized to oral vignettes to a greater degree for the EBI participants than for the VL participants.,"[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Ferman', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University, 120 Bloomfield Avenue, Caldwell, NJ 07006 USA.'}, {'ForeName': 'Kenneth F', 'Initials': 'KF', 'LastName': 'Reeve', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University, 120 Bloomfield Avenue, Caldwell, NJ 07006 USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Vladescu', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University, 120 Bloomfield Avenue, Caldwell, NJ 07006 USA.'}, {'ForeName': 'Leif K', 'Initials': 'LK', 'LastName': 'Albright', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University, 120 Bloomfield Avenue, Caldwell, NJ 07006 USA.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Jennings', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University, 120 Bloomfield Avenue, Caldwell, NJ 07006 USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Domanski', 'Affiliation': 'The DATA Group, Atlantic Highlands, NJ USA.'}]",Behavior analysis in practice,['10.1007/s40617-019-00355-4']
2488,32642464,Impact of text message-based intervention for weight control and health-promoting lifestyle behaviors of overweight and obese children.,"BACKGROUND AND AIM


Little information is available on the use of text messages through mobile phones to address overweight/obesity in children. This study aims to evaluate the impact of a text message-based intervention for weight control and health-promoting lifestyle behaviors of overweight/obese children.
MATERIALS AND METHODS


This quasi-experimental study was conducted among overweight/obese school students. Data on sociodemographic, dietary intake, sleep, sedentary behavior, physical activity (PA), and anthropometry were collected before and after the intervention. Weight and height were examined according to the standard protocols. The intervention was consisted of tailored messages for weight control and healthy lifestyle, including diet, PA, sedentary behavior, and sleep. Child attitude and his practice were asked before and after the intervention. The paired  t -test was performed to compare means of continuous variables before and after the intervention for normal distribution data. The Wilcoxon test was also used for nonnormal data.
RESULTS


A total of 71 boy students were included in the study (62% obese). The mean age was 10.07 years. The means of attitude score for PA, nutrition, and sleep after intervention were greater than before it, but it was significant only for PA. The mean of nighttime sleep duration of students after the intervention was significantly less. Furthermore, unhealthy score decreases after the intervention.
CONCLUSION


Three-month lifestyle intervention as text messages had positive effects on the nutritional intake of obese children and their attitudes toward PA, but no effect on child body mass index.",2020,The mean of nighttime sleep duration of students after the intervention was significantly less.,"['overweight and obese children', 'children', 'overweight/obese school students', 'A total of 71 boy students were included in the study (62% obese', 'overweight/obese children']","['text message-based intervention', 'text message-based intervention for weight control and health']","['Weight and height', 'attitude score for PA, nutrition, and sleep', 'sociodemographic, dietary intake, sleep, sedentary behavior, physical activity (PA), and anthropometry', 'mean of nighttime sleep duration']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",71.0,0.0198064,The mean of nighttime sleep duration of students after the intervention was significantly less.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Bahreynian', 'Affiliation': 'Department of Nutrition, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Khoshhali', 'Affiliation': 'Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_707_19']
2489,32642465,The effect of problem-solving-based interprofessional learning on critical thinking and satisfaction with learning of nursing and midwifery students.,"INTRODUCTION


Problem-solving skills and learner-centered approaches provide students with the ability to solve health challenges by placing them in simulated situations. The aim of this study was to determine the effect of inter-professional learning based on problem-solving on critical thinking (CT) and satisfaction with learning experience in nursing and midwifery students.
METHODS


This quazi-experimental study of a single group used pretest-posttest design. 20 undergraduate nursing and 28 midwifery students at the final academic year participated in the study. The research intervention was interprofessional learning based on problem-solving conducted in five 2-h training sessions. California's CT Scale and 10-point visual analog scale were used to measure CT skills and satisfaction with learning before and after the intervention. Finally, data were analyzed by SPSS software version 23 using descriptive statistics and paired  t -test.
RESULTS


The findings of this study indicated that the mean score of students' CT before the intervention was poor, while it statistically significant increased after the intervention ( P  < 0.05). It was also found that students' satisfaction with learning, in the scale of 0-10, was reported from 5 to 9 indicating students had a high level of satisfaction with their learning experience.
DISCUSSION


Based on the findings, it can be concluded that the interprofessional education based on problem-solving has been able to significantly enhance the overall critical skills of students, especially in the dimensions of analysis, inference, and deductive reasoning, and also, students' satisfaction with learning experience was also increased.",2020,"Based on the findings, it can be concluded that the interprofessional education based on problem-solving has been able to significantly enhance the overall critical skills of students, especially in the dimensions of analysis, inference, and deductive reasoning, and also, students' satisfaction with learning experience was also increased.","['20 undergraduate nursing and 28 midwifery students at the final academic year participated in the study', 'nursing and midwifery students']","['professional learning based on problem-solving on critical thinking (CT', 'problem-solving-based interprofessional learning']","[""California's CT Scale and 10-point visual analog scale"", 'CT skills and satisfaction with learning']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]","[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",20.0,0.0142609,"Based on the findings, it can be concluded that the interprofessional education based on problem-solving has been able to significantly enhance the overall critical skills of students, especially in the dimensions of analysis, inference, and deductive reasoning, and also, students' satisfaction with learning experience was also increased.","[{'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Aein', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'RaziehSadat', 'Initials': 'R', 'LastName': 'Hosseini', 'Affiliation': 'Nursing Care Research Center, School of Nursing an Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Naseh', 'Affiliation': 'Sharekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Farhanak', 'Initials': 'F', 'LastName': 'Safdari', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Banaian', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_640_19']
2490,32642468,The effect of performance feedback and educational video on endotracheal-suctioning practices of critical care nurses.,"INTRODUCTION


Majority of critical care nurses do not have desirable skills in performing endotracheal tube suctioning (ETS) despite related training taught in the curricula. This study aimed to investigate and compare the effect of education through video and performance feedback (PF) on nurses' skills in performing ETS.
METHODS


This was a quasi-experimental study. The sample size comprised of all nurses ( n  = 49) working in the intensive care unit of one of the educational hospital located in one of the western cities of Iran. Nurses were assigned to either one of educational video (EV) and PF groups. Data were collected using a 25-item structured best practices information sheet. Data were analyzed using SPSS software version 20 (SPSS Inc., Chicago, IL, USA).
RESULTS


After the interventions, no significant difference was found in the total mean score of nurses' practice in ETS between those who received education through EV and those who received through PF (16.3 vs. 15.1) ( P  > 0.05). Before and after the intervention, a significant improvement was observed in the total mean score and other dimensions of nurses' practice in endotracheal suctioning ( P  < 0.0001).
CONCLUSIONS


The results showed that both of methods through feedback and EV are useful in improving nurses' ETS practice. However, further studies are required to examine the effects of such interventions in the long term.",2020,"Before and after the intervention, a significant improvement was observed in the total mean score and other dimensions of nurses' practice in endotracheal suctioning ( P  < 0.0001).
","[""nurses' skills in performing ETS"", 'sample size comprised of all nurses ( n  = 49) working in the intensive care unit of one of the educational hospital located in one of the western cities of Iran', 'endotracheal-suctioning practices of critical care nurses']","['endotracheal tube suctioning (ETS', 'performance feedback and educational video', 'education through video and performance feedback (PF']","[""total mean score and other dimensions of nurses' practice in endotracheal suctioning"", ""total mean score of nurses' practice in ETS""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}]",49.0,0.0270696,"Before and after the intervention, a significant improvement was observed in the total mean score and other dimensions of nurses' practice in endotracheal suctioning ( P  < 0.0001).
","[{'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Azizian', 'Affiliation': 'Student Research Committee, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Azadi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Veisani', 'Affiliation': 'Department of Psychosocial Injuries Research Center, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Bastami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_759_19']
2491,32642471,The effect of rehabilitation education on anxiety in knee replacement patients.,"BACKGROUND


Total knee arthroplasty (TKA) can cause operational anxiety in patients. The purpose of this study was to determine the effects of a hospital rehabilitation program on operational anxiety in patients following TKA.
MATERIALS AND METHODS


A nonrandomized clinical trial was conducted on 96 patients who were total knee replacement (TKR) candidates in Milad Hospital, Tehran, Iran. The participants were allocated to two groups of control and experiment each with 48 participants. A rehabilitation training program was implemented in the experimental group and the routine care program was administered to the control group. The data collected through demographic form and Spielberger anxiety questionnaire. The collected data were analyzed using Fisher's exact test, covariance, independent  t -test, and paired  t -test ( P  = 0.5).
RESULTS


The results of the paired  t -test indicated that the mean score of anxiety in both groups was decreased. Independent  t -test showed that there was a significant difference between the two groups in terms of the mean scores of anxiety so that it was significantly higher in the control group compared to the experimental group ( P  < 0.001).
CONCLUSIONS


The implementation of the rehabilitation education by a rehab nurse can improve the surgical outcomes in patients under TKR. Despite the positive results in this study, the results should be interpreted and clinically used with caution given the small number of participants and the specific circumstances of this study.",2020,"Independent  t -test showed that there was a significant difference between the two groups in terms of the mean scores of anxiety so that it was significantly higher in the control group compared to the experimental group ( P  < 0.001).
","['patients following TKA', 'patients under TKR', '96 patients who were total knee replacement (TKR) candidates in Milad Hospital, Tehran, Iran', 'patients', 'knee replacement patients']","['rehabilitation education', 'hospital rehabilitation program', 'Total knee arthroplasty (TKA']","['mean scores of anxiety', 'operational anxiety', 'mean score of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",96.0,0.0262534,"Independent  t -test showed that there was a significant difference between the two groups in terms of the mean scores of anxiety so that it was significantly higher in the control group compared to the experimental group ( P  < 0.001).
","[{'ForeName': 'Sheyda', 'Initials': 'S', 'LastName': 'Atabaki', 'Affiliation': 'Department of Medical Surgical Nursing, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Department of Medical Surgical Nursing, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Safoura', 'Initials': 'S', 'LastName': 'Dorri', 'Affiliation': 'Department of Medical Surgical Nursing, Student Research Committee, Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansoureh Ashghali', 'Initials': 'MA', 'LastName': 'Farahani', 'Affiliation': 'Department of Medical Surgical Nursing, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_6_20']
2492,32642473,"Effect of the combination of Benson's relaxation technique and brief psychoeducational intervention on religious coping, sense of coherence, and quality of life of family caregivers.","INTRODUCTION


Chronic diseases leave a huge impact on the life of children and their family caregivers (FCGs). Therefore, the present study was conducted to determine the effect of the combination of Benson's relaxation technique (BRT) and brief psycho-educational intervention (BPI) on religious coping (RCOPE), sense of coherence (SOC), and quality of life (QoL) of FCGs in children with chronic disease.
MATERIALS AND METHODS


The study population, consisted of 100 FCGs whose children were afflicted by chronic diseases, and participated in the current quasi-experimental pretest posttest design. The children were recruited from two state pediatric hospitals in Tehran, Iran. The RCOPE, SOC, and QoL of FCGs were assessed twice, through pretest (T1) and posttest (T2), four weeks after the intervention, by means of RCOPE, SOC and SF-36 questionnaires. The FCGs participated in four training sessions lasting up to 70 min over one week, followed by four more weeks of training. The Chi-square, Fisher's exact tests, independent  t -test, and paired  t -test were performed.
RESULTS


Positive RCOPE had a significant rise at T2 ( P  = 0.020) compared with negative RCOPE that did not show significant changes in T2. SOC scores for the intervention group remarkably rose at T2 ( P  = 0.022); but, for the control group, the drop was marginal. The QoL scores of both physical and mental components were statistically significant in the intervention group at T2 ( P  < 0.05).
CONCLUSION


Findings of the present study suggest that BRT and BPI can help significantly improve the RCOPE, SOC, and QoL of families with children suffering from chronic diseases. Measures that could enhance the RCOPE, SOC, and QoL include low-cost interventions, good safety, and decent outcome.",2020,"RESULTS


Positive RCOPE had a significant rise at T2 ( P  = 0.020) compared with negative RCOPE that did not show significant changes in T2.","['children with chronic disease', 'children were recruited from two state pediatric hospitals in Tehran, Iran', 'The study population, consisted of 100 FCGs whose children were afflicted by chronic diseases, and participated in the current quasi-experimental pretest posttest design']","[""combination of Benson's relaxation technique (BRT) and brief psycho-educational intervention (BPI"", ""combination of Benson's relaxation technique and brief psychoeducational intervention""]","['SOC scores', 'religious coping, sense of coherence, and quality of life of family caregivers', 'religious coping (RCOPE), sense of coherence (SOC), and quality of life (QoL) of FCGs', 'RCOPE, SOC, and QoL include low-cost interventions, good safety, and decent outcome', 'RCOPE, SOC, and QoL of FCGs', 'QoL scores of both physical and mental components', 'RCOPE, SOC, and QoL of families']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",100.0,0.0241312,"RESULTS


Positive RCOPE had a significant rise at T2 ( P  = 0.020) compared with negative RCOPE that did not show significant changes in T2.","[{'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Mowla', 'Affiliation': ""Vice-Chancellor's Office in Treatment Affairs, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Khanjari', 'Affiliation': 'Nursing Care Research Center, Department of Pediatric Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_653_19']
2493,32642486,The effectiveness of mindfulness-based intervention on perceived stress and perception of disease in patients with acute coronary syndrome.,"CONTEXT


One of the most important issues in patients with coronary artery disease is their mental health indices such as perceived stress and perception of disease.
AIMS


The aim of this study was to evaluate the effectiveness of mindfulness-based intervention on the perceived stress and disease perception of patients with acute coronary syndrome.
MATERIALS AND METHODS


This is a clinical trial, two-group, and three-stage study on 76 patients with acute coronary syndrome who were randomly divided into intervention and control groups. Nine weekly sessions of mindfulness-based training program were administered to the intervention group. The control group received routine services during this period. Data collection was done before, immediately, and 1 month after the intervention, using the Perceived Stress Scale and the Illness Perception Questionnaire. Data were analyzed using descriptive and inferential statistics.
RESULTS


There was no significant difference between the mean scores of perceived stress and illness perception before intervention. After the intervention and 1 month after it, the mean score of perceived stress in the intervention group was statistically significantly lower than the control group ( P  < 0.001), and the perception of disease in the intervention group was statistically significantly higher than that of the control group ( P  < 0.001).
CONCLUSIONS


It is worthwhile to suggest the mindfulness-based training program to reduce the perceived stress and correct the perception of disease for patients with acute coronary syndrome.",2020,"After the intervention and 1 month after it, the mean score of perceived stress in the intervention group was statistically significantly lower than the control group ( P  < 0.001), and the perception of disease in the intervention group was statistically significantly higher than that of the control group ( P  < 0.001).
","['patients with acute coronary syndrome', '76 patients with acute coronary syndrome', 'patients with coronary artery disease']","['mindfulness-based training program', 'mindfulness-based intervention']","['mean score of perceived stress', 'perception of disease', 'Perceived Stress Scale and the Illness Perception Questionnaire', 'mean scores of perceived stress and illness perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",76.0,0.0145988,"After the intervention and 1 month after it, the mean score of perceived stress in the intervention group was statistically significantly lower than the control group ( P  < 0.001), and the perception of disease in the intervention group was statistically significantly higher than that of the control group ( P  < 0.001).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nasiri', 'Affiliation': 'MS Student of Psychiatric Nursing, Student Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Alavi', 'Affiliation': 'Psychiatric Nursing Department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ghazavi', 'Affiliation': 'Psychiatric Nursing Department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Rabiei', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_660_19']
2494,32642499,Effectiveness of Spiritual Intervention toward Coping and Spiritual Well-being on Patients with Gynecological Cancer.,"Objective


Coping and spiritual well-being are two important things in improving quality of life of patients with gynecological cancer. However, both of them are still neglected. Spiritual interventions are one of the alternatives in improving coping and spiritual well-being of patients with gynecological cancer. Right now, this intervention is not developed yet in Indonesia, especially about the effect on coping and spiritual well-being. This study aims at determining the effectiveness of spiritual intervention toward coping and spiritual well-being on patients with gynecological cancer.
Methods


This was a quantitative research with quasi-experimental method and used a pre- and posttest with control design. The number of respondents in this study was 108 patients (54 patients in each group) and used consecutive sampling. The intervention group received spiritual intervention and the control group received usual care. Spiritual intervention was provided by certified oncology nurses of spiritual training. The instrument used for measuring coping is Brief COPE Scale and Functional Assessment of Chronic Illness Therapy-Spiritual Therapy (FACIT-Sp-12) for measuring spiritual well-being.
Results


There was a positive change in the average scores of coping ( P  = 0.001) and spiritual well-being in the intervention group after receiving spiritual intervention ( P  = 0.006). The result of this research also shows that there was a significant difference in the average score of coping ( P  = 0.004) and spiritual well-being ( P  = 0.001) after spiritual intervention between intervention and control groups.
Conclusions


This study shows that coping and spiritual well-being in the intervention group increased significantly after receiving spiritual intervention.",2020,There was a positive change in the average scores of coping ( P  = 0.001) and spiritual well-being in the intervention group after receiving spiritual intervention ( P  = 0.006).,"['patients with gynecological cancer', '108 patients (54 patients in each group) and used consecutive sampling', 'Patients with Gynecological Cancer']","['Chronic Illness Therapy-Spiritual Therapy (FACIT-Sp-12', 'Spiritual intervention', 'Spiritual Intervention toward Coping and Spiritual Well-being', 'spiritual intervention and the control group received usual care', 'spiritual intervention toward coping and spiritual well-being']","['quality of life', 'average score of coping', 'average scores of coping']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0679674', 'cui_str': 'Spiritual therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",108.0,0.0142761,There was a positive change in the average scores of coping ( P  = 0.001) and spiritual well-being in the intervention group after receiving spiritual intervention ( P  = 0.006).,"[{'ForeName': 'Lina Anisa', 'Initials': 'LA', 'LastName': 'Nasution', 'Affiliation': ""Department of Maternity and Women's Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.""}, {'ForeName': 'Yati', 'Initials': 'Y', 'LastName': 'Afiyanti', 'Affiliation': ""Department of Maternity and Women's Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.""}, {'ForeName': 'Wiwit', 'Initials': 'W', 'LastName': 'Kurniawati', 'Affiliation': ""Department of Maternity and Women's Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.""}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_4_20']
2495,32642501,Effectiveness of A Traditional Training Method in Increasing Long-Term End-of-Life Care Perception and Clinical Competency among Oncology Nurses: A Pilot Clinical Trial.,"Objective


Patients with cancer face numerous problems at the end of their lives, which makes palliative care necessary for a peaceful death. Considering the important role nurses play in the provision of end-of-life care, the present study was conducted to study the effect of a traditional training method on nurses' perception of and clinical competency in providing end-of-life care to patients with cancer in a hospital in Southeastern Iran.
Methods


This was a pilot clinical trial in which the nurses in an oncology ward were allocated to two groups, experimental ( n  = 24) and control ( n  = 33), using a table of random numbers. The experiment group received three sessions of workshop training. The nurses' perception and clinical competency were measured before and 3 months postintervention.
Results


The results showed the perception scores in the experimental and control groups to be 171.75 ± 19.54 and 170.03 ± 17.03 before education and 176.16 ± 19.54 and 176.12 ± 16.12 postintervention, respectively. The scores of clinical competency were 98.71 ± 10.24 and 99.58 ± 12.17 before education and 101.5 ± 14.67 and 104.97 ± 12 postintervention in the experimental and control groups, respectively. According to the findings, neither of the groups showed a significant difference between pre- and post-intervention in terms of perception of or clinical competency in end-of-life care.
Conclusions


A traditional training method such as workshop training cannot cause long-term improvement in nurses' end-of-life care perception or clinical competency. It seems that nurses would benefit from acquiring cognitive and behavioral skills and knowledge through a more continuous form of instruction delivered through modern blended educational methods.",2020,"According to the findings, neither of the groups showed a significant difference between pre- and post-intervention in terms of perception of or clinical competency in end-of-life care.
","['Oncology Nurses', 'patients with cancer in a hospital in Southeastern Iran']","['Traditional Training Method', 'traditional training method', 'workshop training']","['perception scores', 'perception of or clinical competency']","[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008956', 'cui_str': 'Competence, Clinical'}]",,0.029533,"According to the findings, neither of the groups showed a significant difference between pre- and post-intervention in terms of perception of or clinical competency in end-of-life care.
","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Omidi', 'Affiliation': 'School of Nursing and Midwifery, Iranshahr University of Medical Sciences, Iranshahr, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Razi School of Nursing and Midwifery, Department of Critical Care Nursing, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Parvin Mangolian', 'Initials': 'PM', 'LastName': 'Shahrbabaki', 'Affiliation': 'Nursing Research Center, Razi School of Nursing and Midwifery, Department of Critical Care Nursing, Kerman University of Medical Sciences, Kerman, Iran.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_15_20']
2496,32642588,Hydrocolloid versus silicone gel for the prevention of nasal injury in newborns submitted to noninvasive ventilation: A randomized clinical trial.,"Purpose


To compare the effectiveness of the hydrocolloid and the silicone gel on the nasal protection of the newborns (NBs) during the use of noninvasive ventilation (NIV).
Materials and methods


Thirty-three NBs were selected. They were randomly divided into three groups of 11 NBs, according to the type of nasal protection used: hydrocolloid, thick silicone gel, and thin silicone gel. The stage of the nasal injury and need for exchanging nasal protection were assessed before the connection to the NIV and every 24 h until the physician's authorization for NIV's suspension.
Results


The mean gestational age was 32.03 ± 3.93 weeks, and the median birth weight was 1760 g (750-3535 g). The incidence of nasal injury using hydrocolloid, thick silicone gel, and a thin silicone gel group was 36.36%, 81.81%, and 72.72%, respectively (p = 0.06). Regarding the injury stage, there was no statistical significance between the three study groups. The hydrocolloid protection type had the best adhesion (p = 0.03) on the NBs' skin.
Conclusions


Although this study was conducted by local practice patterns, the results showed that the hydrocolloid could be the best choice to prevent the nasal septum base injury in the NB submitted to NIV.",2020,"The hydrocolloid protection type had the best adhesion (p = 0.03) on the NBs' skin.
","['Materials and methods\n\n\nThirty-three NBs were selected', 'newborns submitted to noninvasive ventilation']","['noninvasive ventilation (NIV', 'Hydrocolloid versus silicone gel', 'hydrocolloid', 'hydrocolloid, thick silicone gel, and thin silicone gel', 'hydrocolloid, thick silicone gel, and a thin silicone gel', 'hydrocolloid and the silicone gel']","['incidence of nasal injury', 'median birth weight']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0599034', 'cui_str': 'Silicone Gels'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0272427', 'cui_str': 'Injury of nose'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",33.0,0.0192384,"The hydrocolloid protection type had the best adhesion (p = 0.03) on the NBs' skin.
","[{'ForeName': 'Débora de Fátima', 'Initials': 'DF', 'LastName': 'Camillo Ribeiro', 'Affiliation': 'Neonatal Services, Waldemar Monastier Hospital, Rua XV de Novembro 3701, Bom Jesus, Campo Largo, Paraná, Brazil.'}, {'ForeName': 'Frieda Saicla', 'Initials': 'FS', 'LastName': 'Barros', 'Affiliation': 'Graduate Program on Biomedical Engineering, Universidade Tecnológica Federal do Paraná, Avenida Sete de Setembro 3165, Rebouças, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Beatriz Luci', 'Initials': 'BL', 'LastName': 'Fernandes', 'Affiliation': 'Graduate Program on Health Technology, Pontifícia Universidade Católica do Paraná, Rua Imaculada Conceição 1155, Prado Velho, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Adriane Muller', 'Initials': 'AM', 'LastName': 'Nakato', 'Affiliation': 'Graduate Program on Health Technology, Pontifícia Universidade Católica do Paraná, Rua Imaculada Conceição 1155, Prado Velho, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Nohama', 'Affiliation': 'Graduate Program on Biomedical Engineering, Universidade Tecnológica Federal do Paraná, Avenida Sete de Setembro 3165, Rebouças, Curitiba, Paraná, Brazil.'}]",Heliyon,['10.1016/j.heliyon.2020.e04366']
2497,32642593,Sustainability of barefoot nurse (BFN) project - Screening NCD and ensuring livelihood: A randomized control trial.,"Cost-benefit analysis underlines the importance of screening non-communicable diseases (NCDs) and seeking treatment which can aid early detection, cutting expenses and averting deaths. The government of India NCD screening program leaves many to opportunistic screening whilst the health system is inadequate to deliver its goal due to short-staffing, underequipped, and incomplete data management. In order to ease the cost and convenience barrier faced by the Indian poor, we propose testing the efficacy and sustainability of Community Health Workers (CHW), referred to as Barefoot nurse (BFN) for screening NCD. The BFN intervention will be evaluated using a two-arm cluster randomized controlled trial. The participants of the study are residents of eight selected wards each of Doddabalapura and Hoskote respectively, North Bangalore, Karnataka. The intervention will be delivered by eight BFNs. The control area will receive usual care by the Auxiliary Nurse midwife (ANM). The primary outcome indicators are a) proportion of population screened for NCDs, b) proportion of population, diagnosed with NCDs repeated the screening, c) proportion of first-time detection and referral. The secondary outcome measures are a) average amount of money earned, b) timeliness and c) completeness of data entry. Cluster randomization will be done prior to recruitment of participants. Enrolment of cluster will ensure non-overlap of intervention and control wards. The net change in the key outcome measures will be assessed using the difference in difference (DID). Amidst huge NCD burden the proposed study seeks to test the efficacy of a self-sustainable CHW model in resource deficient areas.",2020,Amidst huge NCD burden the proposed study seeks to test the efficacy of a self-sustainable CHW model in resource deficient areas.,"['participants of the study are residents of eight selected wards each of Doddabalapura and Hoskote respectively, North Bangalore, Karnataka']","['barefoot nurse (BFN) project - Screening NCD and ensuring livelihood', 'BFN intervention']","[' proportion of population screened for NCDs, b) proportion of population, diagnosed with NCDs repeated the screening, c) proportion of first-time detection and referral', ' average amount of money earned, b) timeliness and c) completeness of data entry']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}]",,0.0439111,Amidst huge NCD burden the proposed study seeks to test the efficacy of a self-sustainable CHW model in resource deficient areas.,"[{'ForeName': 'Biswamitra', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'IIPH, Population Council, India.'}, {'ForeName': 'Sathyanarayana', 'Initials': 'S', 'LastName': 'Tn', 'Affiliation': 'IIPH, Population Council, India.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'IIPH, Population Council, India.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100602']
2498,32642816,Stress Among a Sample of Returning Citizens Living with HIV and Substance Use Disorder: A Mixed Methods Analysis.,"This mixed-methods study asks: among a sample of returning citizens living with HIV and substance use disorder, how is stress experienced; and what are the leading stressors and stress-coping strategies? Data is from a parent study that randomized 36 people to a yoga intervention and 36 people to treatment as usual. Qualitative analysis found that securing basic life needs was more acute in early reentry, and challenges with HIV acceptance were greater among those with a more recent HIV diagnosis. Social support was the most widely employed coping strategy but many lacked social networks. Post-program, multiple regression found older age(β = - 0.38, p < .05), greater income(β = - 0.002, p < .01), shorter incarceration(β = .03, p < .01) and randomization to yoga(β = 6.92, p < .01) predicted lower levels of stress. Results indicate that reentry needs for people living with HIV and substance use disorder include basic life needs, social supports, and stress-coping interventions that address physical and mental stress symptoms (such as yoga).",2020,"Post-program, multiple regression found older age(β = - 0.38, p < .05), greater income(β = - 0.002, p < .01), shorter incarceration(β = .03, p < .01) and randomization to yoga(β = 6.92, p < .01) predicted lower levels of stress.","['36 people to a yoga intervention and 36 people to treatment as usual', 'Stress Among a Sample of Returning Citizens Living with HIV and Substance Use Disorder', 'returning citizens living with HIV and substance use disorder']",[],"['levels of stress', 'HIV acceptance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",[],"[{'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",36.0,0.0767191,"Post-program, multiple regression found older age(β = - 0.38, p < .05), greater income(β = - 0.002, p < .01), shorter incarceration(β = .03, p < .01) and randomization to yoga(β = 6.92, p < .01) predicted lower levels of stress.","[{'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA. awimberly@ssw.umaryland.edu.'}, {'ForeName': 'Orrin D', 'Initials': 'OD', 'LastName': 'Ware', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Bazell', 'Affiliation': 'School of Social Work, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Erica M S', 'Initials': 'EMS', 'LastName': 'Sibinga', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Community mental health journal,['10.1007/s10597-020-00667-8']
2499,32642847,"Learning curves, potential and speed in training of laparoscopic skills: a randomised comparative study in a box trainer.","BACKGROUND


The effectiveness of practical surgical training is characterised by an inherent learning curve. Decisive are individual initial starting capabilities, learning speed, ideal learning plateaus, and resulting learning potentials. The quantification of learning curves requires reproducible tasks with varied levels of difficulty. The hypothesis of this study is that the use of three-dimensional (3D) vision is more advantageous than two-dimensional vision (2D) for the learning curve in laparoscopic training.
METHODS


Forty laparoscopy novices were recruited and randomised to a 2D Group and a 3D Group. A laparoscopy box trainer with two standardised tasks was used for training of surgical tasks. Task 1 was a positioning task, while Task 2 called for laparoscopic knotting as a more complex process. Each task was repeated at least ten times. Performance time and the number of predefined errors were recorded. 2D performance after 3D training was assessed in an additional final 2D cycle undertaken by the 3D Group.
RESULTS


The calculated learning plateaus of both performance times and errors were lower for 3D. Independent of the vision mode the learning curves were smoother (exponential decay) and efficiency was learned faster than precision. The learning potentials varied widely depending on the corresponding initial values and learning plateaus. The final 2D performance time of the 3D-trained group was not significantly better than that of the 2D Group. The final 2D error numbers were similar for all groups.
CONCLUSIONS


Stereoscopic vision can speed up laparoscopic training. The 3D learning curves resulted in better precision and efficiency. The 3D-trained group did not show inferior performance in the final 2D cycle. Consequently, we encourage the training of surgical competences like suturing and knotting under 3D vision, even if it is not available in clinical routine.",2020,The final 2D performance time of the 3D-trained group was not significantly better than that of the 2D Group.,['Forty laparoscopy novices'],[],"['Learning curves, potential and speed in training of laparoscopic skills', '2D performance', 'final 2D error numbers', 'Performance time and the number of predefined errors', 'precision and efficiency', 'final 2D performance time']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",[],"[{'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",40.0,0.0258156,The final 2D performance time of the 3D-trained group was not significantly better than that of the 2D Group.,"[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kunert', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}, {'ForeName': 'Pirmin', 'Initials': 'P', 'LastName': 'Storz', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Dietz', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Axt', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Falch', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kirschniak', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany. andreas.kirschniak@uni-tuebingen.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wilhelm', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, Surgical Technology and Training, Tuebingen University Hospital, Waldhoernlestrasse 22, 72072, Tuebingen, Germany.'}]",Surgical endoscopy,['10.1007/s00464-020-07768-1']
2500,32642953,Photobiomodulation for mucosal repair in patients submitted to dental extraction after head and neck radiation therapy: a double-blind randomized pilot study.,"OBJECTIVE


The aim of this study was to evaluate the efficacy of photobiomodulation therapy (PBMT) on the mucosal healing of patients submitted to simple dental extractions after head and neck radiation therapy (HNRT).
METHODS


Forty surgical procedures were randomly assigned into two groups: G1: dental extraction + PBMT (n = 19) and G2: dental extraction + sham-PBMT (n = 21). All patients received antibiotic therapy and the surgical alveolotomy to promote primary closure of the surgical site. Group 1 was submitted to PMBT according to the following parameters: 808 nm, 40 mW, 100 J/cm 2 , 70 s, 2.8 J/point, 14 J/session, and area of 0.028cm 2 . The primary outcome was complete mucosal lining at 14 days, and the secondary outcomes were the presence of infection, postoperative pain, and analgesics intake at 7 days. The patients were evaluated every 7 days until 28 days.
RESULTS


Alveolar mucosal lining was faster in G1, and at 14 postoperative days, 94.7% patients evolved with complete alveolar mucosal lining compared to no patient from G2 (p < 0.001). Patients from G1 reported postoperative pain less frequently (G1 = 4, 21.1% × G2 = 14, 66.7%, p = 0.005), and also reported lower intake of analgesic pills at D7 (21.1% × 66.7%, p = 0.005%). PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
CONCLUSIONS


This preliminary study strongly supports the use of PMBT to promote surgical alveolar mucosal lining in a shorter time and with less postoperative pain.",2020,"PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
","['patients submitted to simple dental extractions after head and neck radiation therapy (HNRT', 'patients submitted to dental extraction after head and neck radiation therapy', 'Forty surgical procedures']","['photobiomodulation therapy (PBMT', 'PMBT', 'G1: dental extraction + PBMT (n\u2009=\u200919) and G2: dental extraction + sham-PBMT', 'antibiotic therapy', 'PBMT']","['lower intake of analgesic pills', 'presence of infection, postoperative pain, and analgesics intake', 'Alveolar mucosal lining', 'postoperative pain', 'complete mucosal lining', 'mucosal healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0176391', 'cui_str': 'Simple extraction of tooth'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0449970', 'cui_str': 'Presence of infection'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.0962627,"PBMT had a significant positive impact on both postoperative pain (NNT = 2.192, CI95% = 1.372-5.445) and mucosal healing (NNT = 1.056, CI95% = 0.954-1.181).
","[{'ForeName': 'Thyago Morais Vicente', 'Initials': 'TMV', 'LastName': 'da Silva', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Thayanara Silva', 'Initials': 'TS', 'LastName': 'Melo', 'Affiliation': 'Graduate Program in Dentistry, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Romulo Cesar', 'Initials': 'RC', 'LastName': 'de Alencar', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'José Ricardo Dias', 'Initials': 'JRD', 'LastName': 'Pereira', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Jair Carneiro', 'Initials': 'JC', 'LastName': 'Leão', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Igor Henrique Morais', 'Initials': 'IHM', 'LastName': 'Silva', 'Affiliation': 'Dental Oncology Unit, Hospital do Câncer de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Luiz Alcino', 'Initials': 'LA', 'LastName': 'Gueiros', 'Affiliation': 'Oral Medicine Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, CDU, Recife, PE, 50670-901, Brazil. luiz.mgueiros@ufpe.br.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05608-5']
2501,32642957,"Brief Report: Intranasal Ketamine in Adolescents and Young Adults with Autism Spectrum Disorder-Initial Results of a Randomized, Controlled, Crossover, Pilot Study.","Dysregulation of glutamate neurotransmission plays a critical role in autism spectrum disorder (ASD) pathophysiology and is a primary target for core deficit research treatment trials. The mechanism of action of ketamine has striking overlap with the theory of ASD as a disorder of synaptic communication and neuronal networks. This two-dose, double-blind, placebo controlled, cross-over pilot trial of intranasal (IN) ketamine targeting core social impairment included individuals with ASD (N = 21) between 14 and 29 years. Participants were randomized to received two doses of IN ketamine (30 and 50 mg) and two doses of matching placebo. No significant impact was noted on the Aberrant Behavior Checklist Social Withdraw subscale. The IN ketamine was well tolerated, with only transient mild adverse effects.",2020,No significant impact was noted on the Aberrant Behavior Checklist Social Withdraw subscale.,"['Adolescents and Young Adults with Autism', 'targeting core social impairment included individuals with ASD (N\u2009=\u200921) between 14 and 29\xa0years']","['intranasal (IN) ketamine', 'ketamine', 'Intranasal Ketamine', 'placebo']",['Aberrant Behavior Checklist Social Withdraw subscale'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]",,0.305169,No significant impact was noted on the Aberrant Behavior Checklist Social Withdraw subscale.,"[{'ForeName': 'Logan K', 'Initials': 'LK', 'LastName': 'Wink', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Reisinger', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Shaffer', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Kaela', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Kelli R', 'Initials': 'KR', 'LastName': 'Dominick', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Ernest V', 'Initials': 'EV', 'LastName': 'Pedapati', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave. MLC 4002, Cincinnati, OH, 45229, USA. craig.erickson@cchmc.org.""}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04542-z']
2502,32651146,Short-term efficacy of ORS formulation and propranolol regimen in children with POTS.,"BACKGROUND


To evaluate the short-term effectiveness of reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol in children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT).
METHODS


Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position. Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT. A total of 70 pediatric patients with POTS were included in the study. POTS patients were divided into two groups based on whether they were prescribed reduced-osmolarity ORS and propranolol or not. The study group comprised patients on a regimen of reduced-osmolarity ORS and propranolol (n=34), while the control group comprised patients who were not prescribed any medication (n=36). The frequency of symptoms and standardized symptom scores were analyzed before and after 3 months of treatment in both groups.
RESULTS


The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
CONCLUSION


The frequency of syncopal attacks was significantly reduced and the symptom scores for OI were improved in the study group. The improvement in OI symptom scores was better in the treatment group than in the control group. The control group symptoms persisted and caused extreme difficulty in their daily activities. In view of its clinical efficacy, we strongly advocate the use of combined treatment of reduced-osmolarity ORS and low-dose propranolol in pediatric patients with POTS.",2020,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","['Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position', 'children with POTS', 'children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT', 'n=34), while the control group comprised patients who were not prescribed any medication (n=36', 'Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT', 'pediatric patients with POTS', '70 pediatric patients with POTS were included in the study']","['reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol', 'propranolol', 'reduced-osmolarity ORS and propranolol', 'ORS formulation and propranolol']","['frequency of symptoms and standardized symptom scores', 'frequency of syncopal attacks', 'syncopal attacks', 'standardized symptom scores', 'symptom scores for OI', 'OI symptom scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C3653405', 'cui_str': 'Oral rehydration salt formulations'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}]",70.0,0.0281252,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","[{'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Yozgat', 'Affiliation': 'Department of Pediatric Cardiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Hafize Otcu', 'Initials': 'HO', 'LastName': 'Temur', 'Affiliation': 'Department of Radiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Senay', 'Initials': 'S', 'LastName': 'Coban', 'Affiliation': 'Department of Pediatric Cardiology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Taliha', 'Initials': 'T', 'LastName': 'Oner', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Utku', 'Initials': 'U', 'LastName': 'Karaarslan', 'Affiliation': ""Department of Pediatrics, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Can Yilmaz', 'Initials': 'CY', 'LastName': 'Yozgat', 'Affiliation': 'Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. Electronic address: yozgatyilmaz@gmail.com.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Karadeniz', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Serap Nur', 'Initials': 'SN', 'LastName': 'Ergor', 'Affiliation': 'Department of Neonatology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Erenberk', 'Affiliation': 'Department of Pediatrics, Bezmialem Vakif University, Istanbul, Turkey.'}]",Archives de pediatrie : organe officiel de la Societe francaise de pediatrie,['10.1016/j.arcped.2020.06.001']
2503,32651161,"Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Low-dose interleukin-2 (ld-IL-2) enhances regulatory T-cell (Treg) function in auto-inflammatory conditions. Neuroinflammation being a pathogenic feature of amyotrophic lateral sclerosis (ALS), we evaluated the pharmacodynamics and safety of ld-IL-2 in ALS subjects.
METHODS


We performed a single centre, parallel three-arm, randomised, double-blind, placebo-controlled study. Eligibility criteria included age < 75 years, disease duration < 5 years, riluzole treatment > 3 months, and a slow vital capacity ≥ 70% of normal. Patients were randomised (1:1:1) to aldesleukin 2 MIU, 1 MIU, or placebo once daily for 5 days every 4 weeks for 3 cycles. Primary outcome was change from baseline in Treg percentage of CD4 +  T cells (%Tregs) following a first cycle. Secondary laboratory outcomes included: %Treg and Treg number following repeated cycles, and plasma CCL2 and neurofilament light chain protein (NFL) concentrations as surrogate markers of efficacy. Safety outcomes included motor-function (ALSFRS-R), slow vital capacity (SVC), and adverse event reports. This trial is registered with ClinicalTrials.gov, NCT02059759.
FINDINGS


All randomised patients (12 per group), recruited from October 2015 to December 2015, were alive at the end of follow-up and included in the intent-to-treat (ITT) analysis. No drug-related serious adverse event was observed. Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms. Primary outcome analysis showed a significant increase (p < 0·0001) in %Tregs in the 2 MIU and 1 MIU arms (mean [SD]: 2 MIU: +6·2% [2·2]; 1 MIU: +3·9% [1·2]) as compared to placebo (mean [SD]: -0·49% [1·3]). Effect sizes (ES) were large in treated groups: 2 MIU ES=3·7 (IC95%: 2·3-4·9) and 1 MIU ES=3·5 (IC95%: 2·1-4·6). Secondary outcomes showed a significant increase in %Tregs following repeated cycles (p < 0·0001) as compared to placebo, and a dose-dependent decrease in plasma CCL2 (p = 0·0049). There were no significant differences amongst the three groups on plasma NFL levels.
INTERPRETATION


Ld-IL-2 is well tolerated and immunologically effective in subjects with ALS. These results warrant further investigation into their eventual therapeutic impact on slowing ALS disease progression.
FUNDING


The French Health Ministry (PHRC-I-14-056), EU H2020 (grant #633413), and the Association pour la Recherche sur la SLA (ARSLA).",2020,"Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms.","['Eligibility criteria included age', 'amyotrophic lateral sclerosis (IMODALS', 'subjects with ALS', 'ALS subjects', 'All randomised patients (12 per group), recruited from October 2015 to December 2015, were alive at the end of follow-up and included in the intent-to-treat (ITT) analysis']","['riluzole treatment', 'aldesleukin 2 MIU, 1 MIU, or placebo', 'placebo']","['motor-function (ALSFRS-R), slow vital capacity (SVC), and adverse event reports', 'injection site reactions and flu-like symptoms', 'change from baseline in Treg percentage of CD4 +  T cells', 'disease duration', 'plasma NFL levels', 'plasma CCL2 and neurofilament light chain protein (NFL) concentrations', 'plasma CCL2']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0218986', 'cui_str': 'Aldesleukin'}, {'cui': 'C0439455', 'cui_str': 'mIU'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}]",,0.755312,"Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Camu', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mickunas', 'Affiliation': ""Department Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London, UK; NIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Veyrune', 'Affiliation': 'Department of Cell and Tisue Engineering, University of Montpellier, CHU Montpellier, Montpellier France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Payan', 'Affiliation': ""Department of Biostatistics, Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France; Department of Pharmacology, AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 47, Bd de l'Hôpital, F-75013 Paris, France.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garlanda', 'Affiliation': 'IRCCS Humanitas Clinical & Research Institute, Milan, Italy; Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Locati', 'Affiliation': 'Humanitas University, Pieve Emanuele, Milan, Italy; Department of Medical Biotechnologies and Translational Medicine, University Milan, Milan Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Juntas-Morales', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pageot', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Malaspina', 'Affiliation': 'Neuroscience and Trauma Centre, Institute of Cell and Molecular Medicine, Department of Neuroimmunology, Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Andreasson', 'Affiliation': 'Department of Psychiatry & Neurochemistry, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Kirby', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, Department of Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Suehs', 'Affiliation': 'Departments of Medical Information and Respiratory Diseases, University of Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Saker', 'Affiliation': 'DNA and Cell Bank, Genethon, Evry, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Masseguin', 'Affiliation': 'Delegation for Clinical Research and Innovation, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'De Vos', 'Affiliation': 'Department of Cell and Tisue Engineering, University of Montpellier, CHU Montpellier, Montpellier France.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry & Neurochemistry, University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, London, UK; UK Dementia Research Institute at UCL, London, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, Department of Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Al-Chalabi', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, Department of Basic and Clinical Neuroscience, King's College London, London, UK; Department of Neurology, King's College Hospital, London, UK.""}, {'ForeName': 'P Nigel', 'Initials': 'PN', 'LastName': 'Leigh', 'Affiliation': 'The Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, Falmer, Brighton BN1 9RY, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Department Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London, UK; NIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK. Electronic address: timothy.tree@kcl.ac.uk.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Bensimon', 'Affiliation': ""Department of Biostatistics, Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France; Department of Pharmacology, AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 47, Bd de l'Hôpital, F-75013 Paris, France; Department of Pharmacology, Sorbonne Université Médecine, F-75013 Paris, France. Electronic address: gbensimon.psl@gmail.com.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102844']
2504,32651286,"A randomized, placebo-controlled phase 2 trial of laquinimod in primary progressive multiple sclerosis.","OBJECTIVE


To evaluate efficacy, safety, and tolerability of laquinimod in patients with primary progressive multiple sclerosis (PPMS).
METHODS


In the randomized, double-blind, placebo-controlled, phase 2 study ARPEGGIO (A Randomized Placebo-controlled trial Evaluating laquinimod in PPMS, Gauging Gradations In MRI and clinical Outcomes), eligible PPMS patients were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 mg or 1.5 mg or matching placebo. Percentage brain volume change (PBVC; primary endpoint) from baseline to week 48 was assessed by MRI. Secondary and exploratory endpoints included clinical and MRI measures. Efficacy endpoints were evaluated using a predefined, hierarchical statistical testing procedure. Safety was monitored throughout the study. The laquinimod 1.5 mg dose arm was discontinued on January 1, 2016 due to findings of cardiovascular events.
RESULTS


374 patients were randomized to laquinimod 0.6 mg (n = 139) or 1.5 mg (n = 95) or placebo (n = 140). ARPEGGIO did not meet the primary endpoint of significant treatment effect with laquinimod 0.6 mg versus placebo on PBVC from baseline to week 48 (adjusted mean difference = 0.016%,  p  = 0.903). Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001). Incidence of adverse events was higher among patients treated with laquinimod 0.6 mg (83%) versus laquinimod 1.5 mg (66%) and placebo (78%).
CONCLUSIONS


Laquinimod 0.6 mg did not demonstrate a statistically significant effect on brain volume loss in PPMS at week 48.",2020,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","['primary progressive multiple sclerosis', 'patients with primary progressive multiple sclerosis (PPMS', '374 patients', 'eligible PPMS patients']","['Placebo', 'laquinimod 0.6 mg or 1.5 mg or matching placebo', 'Laquinimod', 'laquinimod', 'placebo']","['Safety', 'number of new T2 brain lesions', 'clinical and MRI measures', 'brain volume loss', 'Percentage brain volume change (PBVC', 'efficacy, safety, and tolerability', 'Incidence of adverse events', 'PBVC']","[{'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1260208', 'cui_str': 'laquinimod'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",374.0,0.695841,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.) g.giovannoni@qmul.ac.uk.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Steinerman', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Tansy', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Krieger', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': ""From Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (G.G.); Teva Pharmaceuticals R&D, Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA and Department of Neurology, Medical Faculty, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany (V.K.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (J. S.); Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA (A. T.); Teva Pharmaceutical Industries, Great Valley, Pennsylvania, USA (T. L.); Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA (S.K.); Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genoa, and Ospedale Policlinico San Martino-IRCCS, Genoa, Italy (A.U.); Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurology, MS Center Amsterdam, Amsterdam, The Netherlands (B.M.J.U.); Division of Neurology, University of Toronto/MS Centre St Michael's Hospital, Toronto, Canada (X.M.); Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia, Barcelona, Spain (X.M.); Department of Neurology, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain (X.M.); Department of Neurology, Medical Faculty, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany (H.H.); Department of Health Sciences, University of Genoa, Genoa, Italy (M. P. S.); Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA (B.A.C.C.); Saunders Family Professor of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (F.L.); Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands, and UCL Institutes of Neurology and Healthcare Engineering, London, UK (F.B.).""}]",Neurology,['10.1212/WNL.0000000000010284']
2505,32651322,The Effects of Propofol and Sevoflurane on Postoperative Delirium in Older Patients: A Randomized Clinical Trial Study.,"BACKGROUND


Postoperative delirium is associated with adverse postoperative outcomes. However, whether intravenous and inhalation anesthetics are associated with different risks of postoperative delirium remains unknown.
OBJECTIVE


We set up to determine the incidence and duration of postoperative delirium in older patients who had surgery under the intravenous anesthetic propofol or the inhalational anesthetic sevoflurane.
METHODS


Participants were patients who had total hip/knee replacements and were randomized to propofol (N = 106) or sevoflurane (N = 103) anesthesia group. The Confusion Assessment Method was employed by investigators who were blinded to the anesthesia regimen to assess the incidence and duration (days of postoperative delirium per person) of postoperative delirium on postoperative days 1, 2, and 3.
RESULTS


A total of 209 participants (71.2±6.7 years old, 29.2% male) were included in the final data analysis. The incidence of postoperative delirium was 33.0% with propofol anesthesia and 23.3% with sevoflurane anesthesia (p = 0.119, Chi-square test), and we estimated that we would need 316 participants in each arm to detect a potential statistically significant difference. Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
CONCLUSION


This pilot study established a system to compare effects of different anesthetics and generated a hypothesis that propofol trended to have a higher incidence and had longer duration of postoperative delirium than sevoflurane. Additional studies with a larger sample size are needed to test this hypothesis.",2020,"Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
","['older patients who had surgery under the intravenous anesthetic propofol or the inhalational anesthetic sevoflurane', 'Older Patients', 'A total of 209 participants (71.2±6.7 years old, 29.2% male', 'Participants were patients who had total hip/knee replacements']","['propofol', 'sevoflurane', 'Propofol and Sevoflurane', 'sevoflurane anesthesia']","['Postoperative Delirium', 'incidence of postoperative delirium']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242904', 'cui_str': 'General intravenous anesthetic'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",209.0,0.173944,"Days of postoperative delirium per person were higher in the propofol (0.5±0.8) anesthesia group compared to the sevoflurane anesthesia group (0.3±0.5, p = 0.049, Student's t-test).
","[{'ForeName': 'Xinchun', 'Initials': 'X', 'LastName': 'Mei', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Hai-Lin', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, P. R. China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Tongji University School of Medicine, Shanghai, P. R. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Medicine, Divisions of General Medicine and Primary Care and Gerontology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Zhongcong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesia, Geriatric Anesthesia Research Unit, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Psychiatry, Shanghai Tenth People's Hospital, Anesthesia and Brain Research Institute, Tongji University School of Medicine, Shanghai, P. R. China.""}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200322']
2506,32651657,Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction.,"BACKGROUND


Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality.
OBJECTIVES


The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO 2 ), percent-predicted peak VO 2  and oxygen uptake at anaerobic threshold (VO 2 -AT).
METHODS


This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months.
RESULTS


76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO 2  in comparison to control (67 ± 17 to 73 ± 19%; p = 0.01). Additional primary endpoints peak VO 2  and VO 2 -AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively).
CONCLUSION


APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO 2 , an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life.",2020,"Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively).
","['heart failure patients with reduced left ventricular ejection fraction (HFrEF', 'obstructive sleep apnea in heart failure with reduced ejection fraction', 'patients with chronic, stable HFrEF who had moderate-to-severe OSA', '76 patients have been randomized and 58 had complete data for final analysis']","['APAP intervention', 'APAP', 'Automatic positive airway pressure', 'APAP (AutoSet™, ResMed) or nasal strips (control) for 6\xa0months']","['hypoxemia, cardiac function and quality of life', 'peak VO 2  and VO 2 -AT', 'hypoxemia, left ventricular function and quality of life', 'peak oxygen uptake (peak VO 2 ), percent-predicted peak VO 2  and oxygen uptake at anaerobic threshold (VO 2 -AT']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4761101', 'cui_str': 'Automatic positive airway pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}]",76.0,0.0851561,"Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively).
","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany. akleemeyer@hdz-nrw.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bitter', 'Affiliation': 'Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Sauzet', 'Affiliation': 'Epidemiology and International Public Health, Bielefeld School of Public Health and Statistical Consulting Centre, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Rudolph', 'Affiliation': 'Heart Failure Department, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01701-1']
2507,32651711,Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study.,"PURPOSE


This study aimed to examine the complications by comparing two surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA) to one surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA).
METHODS


Two hundred forty-six participants were prospectively randomized into two groups: two-surgeon bilateral TKA and single-surgeon bilateral TKA. While two surgeons performed simultaneous total knee arthroplasty in the two-surgeon bilateral TKA group, one surgeon performed sequentially in the single-surgeon bilateral TKA group. Ninety-day major, and minor complications rate, operative time, estimated blood loss (EBL) and patient-reported outcome measures were analysed.
RESULTS


The two surgeons operated in two-surgeon bilateral TKA group 246 knees in 123 patients, while the single surgeon operated in single-surgeon bilateral TKA group 246 knees of 123 patients. The median operating time was 120 (range 70-151) minutes in the two-surgeon bilateral TKA group and 140 (range 75-190) minutes in the single-surgeon bilateral TKA group (p < 0.001). The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001). The 90-day complications were two major complications (1.6%) in the two-surgeon bilateral TKA group and 11 (8.9%) in the single-surgeon bilateral TKA group (p = 0.01).
CONCLUSION


Two-surgeon simultaneous bilateral TKA is a safe method with lower complication rates compared with single-surgeon sequential bilateral TKA and can be preferred for experienced teams. However, peri- and post-operative care is required to decrease the risk of bleeding, particularly in patients undergoing two-surgeon simultaneous bilateral TKA.
TRIAL REGISTRATION


This study was retrospectively registered in a public trials registry ( https://clinicaltrials.gov/ , NCT04299516).",2020,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"['group 246 knees of 123 patients', 'Two hundred forty-six participants']","['two-surgeon bilateral TKA and single-surgeon bilateral TKA', 'single surgeon operated in single-surgeon bilateral TKA', 'surgeons simultaneous bilateral total knee arthroplasty (two-surgeon bilateral TKA', 'one-stage bilateral total knee arthroplasty\xa0-one surgeon sequential vs. two surgeons simultaneous', 'surgeon sequential bilateral total knee arthroplasty (single-surgeon bilateral TKA']","['complication rates', '90-day complications', 'minor complications rate, operative time, estimated blood loss (EBL', 'median EBL', 'risk of bleeding', 'median operating time', 'simultaneous total knee arthroplasty']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",246.0,0.188458,The median EBL was higher in the two-surgeon bilateral TKA group (p < 0.001).,"[{'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Güngören', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., Fatih, 34093, İstanbul, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04704-9']
2508,32651768,Role of nebulized epinephrine in moderate bronchiolitis: a quasi-randomized trial.,"BACKGROUND/AIMS


Bronchiolitis is the most common lower respiratory illness that characteristically affects the children below 2 years of age accounting about 2-3% of patients admitted to hospital each year [1-4]. We compared the effect of racemic epinephrine (RE) and 3% hypertonic saline (HS) nebulization on the length of stay (LOS) in the hospital.
METHODS


We looked at the infants with moderate bronchiolitis, from October 2013 to March 2014. Out of eighty cases, 16 in HS and 18 in RE groups were enrolled. At the time of admission, 0.2 ml of RE added to 1.8 ml of distilled water was nebulized to RE group, as compared with 2 ml of 3% HS in nebulized form. RE was re-administered if needed on 6 h in comparison with 3% HS at the frequency of 1 to 4 h.
RESULTS


One infant from RE group and three infants from HS group were excluded due to progression towards severe bronchiolitis. The LOS in RE group ranged between 18 and 160 h (mean 45 h), while in HS group, LOS was 18.50-206 h (mean 74.3 h). The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
CONCLUSION


Racemic epinephrine nebulization as first-line medication may significantly reduce the length of hospital stay in infants with moderate bronchiolitis in comparison with nebulized HS.",2020,"The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
","['Out of eighty cases, 16 in HS and 18 in RE groups were enrolled', 'infants with moderate bronchiolitis in comparison with nebulized HS', 'infants with moderate bronchiolitis, from October 2013 to March 2014', 'moderate bronchiolitis']","['Racemic epinephrine', 'racemic epinephrine (RE) and 3% hypertonic saline (HS) nebulization', 'nebulized epinephrine']","['length of stay (LOS', 'progression towards severe bronchiolitis', 'length of hospital stay', 'LOS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205758', 'cui_str': 'Racepinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205758', 'cui_str': 'Racepinephrine'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]",,0.222084,"The LOS was significantly short in RE group (p value 0.015) which was statistically significant.
","[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Yasin', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland. mkmb_12@yahoo.com.'}, {'ForeName': 'Zahir Shah', 'Initials': 'ZS', 'LastName': 'Afridi', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Qasim', 'Initials': 'Q', 'LastName': 'Mahmood', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Akhter Ali', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Condon', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}, {'ForeName': 'Rizwan Ahmed', 'Initials': 'RA', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatric Medicine, University Hospital Kerry, Tralee, Ireland.'}]",Irish journal of medical science,['10.1007/s11845-020-02293-5']
2509,32651769,Training novice robot surgeons: Proctoring provides same results as simulator-generated guidance.,"To understand the influence of proctored guidance versus simulator generated guidance (SGG) on the acquisition dexterity skills in novice surgeons learning RAS (robot assisted surgery). Prospective non-blinded 3-arm randomised controlled trial (RTC). Exclusion criteria: previous experience in RAS or robotic surgery simulation. The participants were assigned to three different intervention groups and received a different form of guidance: (1) proctored guidance, (2) simulator generated guidance, (3) no guidance, during training on virtual reality (VR) simulator. All participants were asked to complete multiple questionnaires. The training was the same in all groups with the exception of the intervention part. Catharina Hospital Eindhoven, The Netherlands. A total of 70 Dutch medical students, PhD-students, and surgical residents were included in the study. The participants were randomly assigned to one of the three groups. Overall, all the participants showed a significant improvement in their dexterity skills after the training. There was no significant difference in the improvement of surgical skills between the three different intervention groups. The proctored guidance group reported a higher participant satisfaction compared to the simulator-generated guidance group, which could indicate a higher motivation to continue the training. This study showed that novice surgeons. Significantly increase their dexterity skills in RAS after a short time of practicing on simulator. The lack of difference in results between the intervention groups could indicate there is a limited impact of ""human proctoring"" on dexterity skills during surgical simulation training. Since there is no difference between the intervention groups the exposure alone of novice surgeons to the robotic surgery simulator could possibly be sufficient to achieve a significant improvement of dexterity skills during the initial steps of RAS learning.",2020,There was no significant difference in the improvement of surgical skills between the three different intervention groups.,"['novice surgeons learning RAS (robot assisted surgery', '70 Dutch medical students, PhD-students, and surgical residents were included in the study']","['proctored guidance versus simulator generated guidance (SGG', 'guidance: (1) proctored guidance, (2) simulator generated guidance, (3) no guidance, during training on virtual reality (VR) simulator']","['participant satisfaction', 'surgical skills', 'dexterity skills']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1739685', 'cui_str': 'PDC protein, human'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}]",70.0,0.0241268,There was no significant difference in the improvement of surgical skills between the three different intervention groups.,"[{'ForeName': 'A J W', 'Initials': 'AJW', 'LastName': 'Beulens', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, The Netherlands. alexander.beulens@catharinaziekenhuis.nl.'}, {'ForeName': 'Y A F', 'Initials': 'YAF', 'LastName': 'Hashish', 'Affiliation': 'Department of Urology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Brinkman', 'Affiliation': 'Department of Oncological Urology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Umari', 'Affiliation': 'Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puliatti', 'Affiliation': 'Urology Department, University of Modena & Reggio Emilia, Modena, Italy.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Koldewijn', 'Affiliation': 'Department of Urology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'A J M', 'Initials': 'AJM', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Urology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'van Basten', 'Affiliation': 'Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'J J G', 'Initials': 'JJG', 'LastName': 'van Merriënboer', 'Affiliation': 'School of Health Professions Education, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Van der Poel', 'Affiliation': 'Department of Urology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, The Netherlands.'}]",Journal of robotic surgery,['10.1007/s11701-020-01118-y']
2510,32649453,"Response to the Comment on ""Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial"".",,2020,,[],['Laparoscopic Appendicectomy'],[],[],"[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]",[],,0.640735,,"[{'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Paediatric Surgery and Surgical Simulation, Monash Children's Hospital, Melbourne, Australia Department of Paediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia Department of Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003864']
2511,32649456,"Invited Commentary on: Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod.",,2020,,[],['Reltecimod'],[],[],[],[],,0.113416,,"[{'ForeName': 'Avery B', 'Initials': 'AB', 'LastName': 'Nathens', 'Affiliation': 'Department of Surgery, Sunnybrook Health Sciences Centre and the University of Toronto, Toronto, Canada.'}]",Annals of surgery,['10.1097/SLA.0000000000004135']
2512,32649485,Prevention of Nasal Ala Pressure Injuries With Use of Hydroactive Dressings in Patients With Nasotracheal Intubation of Orthognathic Surgery: A Randomized Controlled Trial.,"PURPOSE


To compare a hydroactive dressing to an adhesive tape standard of care in the prevention of nasal ala pressure injuries associated with nasotracheal intubation during orthognathic surgery.
DESIGN


Randomized controlled trial.
SUBJECTS AND SETTING


The study took place in a tertiary hospital of stomatology in China. Patients undergoing general anesthesia with nasotracheal intubation during orthognathic surgical procedures were invited to participate.
METHODS


Participants were divided into 2 groups: in the experimental group, a hydroactive dressing was applied to the nasal ala before the surgical procedures; the control group received standard prevention with a type of tape. Skin assessments were performed on the wards up to 72 hours after the procedures. Demographic information and potential contributing factors associated the development of nasal ala pressure injuries were collected from patients' electronic medical records. Pressure injury development was staged using National Pressure Injury Advisory staging guidelines. Pressure injury incidence was compared between groups using the χ test and odds ratio.
RESULTS


The sample comprised 450 participants, 225 in each group. The incidence of nasal ala pressure injuries development was 14.222% and 4.444% in the 2 groups, respectively (P = .000). The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
CONCLUSIONS


The study findings indicate that the incidence of pressure injuries of nasal ala skin protected by hydroactive dressings was lower than the standard preventive method. Hydroactive dressings should be considered as a prevention method to reduce device-related skin injuries associated with nasotracheal intubation.",2020,"The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
","['Patients With Nasotracheal Intubation of Orthognathic Surgery', ""patients' electronic medical records"", '450 participants, 225 in each group', 'tertiary hospital of stomatology in China', 'Patients undergoing general anesthesia with nasotracheal intubation during orthognathic surgical procedures were invited to participate', 'Participants', 'nasal ala pressure injuries associated with nasotracheal intubation during orthognathic surgery']","['hydroactive dressing was applied to the nasal ala before the surgical procedures; the control group received standard prevention with a type of tape', 'hydroactive dressing', 'Hydroactive Dressings']","['Pressure injury incidence', 'incidence of nasal ala pressure injuries development']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C2717941', 'cui_str': 'Orthognathic Surgical Procedures'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",450.0,0.0218455,"The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
","[{'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Guoyong Yang, MSN, RN, CNOR, PACU, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. Chunyan Gao, BSN, RN, CNOR, Operating Room, Peking University School and Hospital of Stomatology, Beijing, China. Juan Cai, BSN, RN, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000675']
2513,32649493,Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether a short course of tamoxifen decreases bothersome bleeding in etonogestrel contraceptive implant users.
METHODS


In a 90-day, double-blind randomized control trial, we enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting. A sample size of 40 per group (N=80) was planned to compare 10 mg tamoxifen or placebo twice daily for 7 days after 3 consecutive days of bleeding or spotting no more than once per 30 days (maximum three treatments). Participants then entered a 90-day open-label study where all received tamoxifen if needed every 30 days (maximum three treatments). Participants used text messages to record daily bleeding patterns. Our primary outcome was the total number of consecutive amenorrhea days after the first treatment. Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
RESULTS


From January 2017 to November 2018, 112 women enrolled in the study; 88 (79%) completed 90 days, and 79 (71%) completed 180 days. Participant characteristics did not differ between groups; mean age 24, majority identified as white not Hispanic with at least some college education. After the first treatment, the tamoxifen group reported an average of 9.8 (95% CI 4.6-15.0) more consecutive days of amenorrhea and more total days of no bleeding (amenorrhea or spotting) in the first 90 days (median 73.5 [range 24-89] vs 68 [range 11-81], P=.001). The placebo group showed a similar treatment benefit after first active use of tamoxifen in the open-label phase. At the end of the randomized study (first 90 days), women who received tamoxifen reported higher satisfaction (median 62 mm [range 16-100]) than those treated with placebo (46 mm [range 0-100]; P=.023).
CONCLUSION


A short course of tamoxifen reduces problematic bleeding and improves satisfaction in users of etonogestrel implants.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02903121.",2020,"Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
","['From January 2017 to November 2018, 112 women enrolled in the study; 88 (79%) completed 90 days, and 79 (71%) completed 180 days', 'enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting', 'users of etonogestrel implants', 'etonogestrel contraceptive implant users', 'Contraceptive Implant Users']","['placebo', 'tamoxifen', 'tamoxifen or placebo']","['total number of consecutive amenorrhea days', 'consecutive days of amenorrhea and more total days of no bleeding (amenorrhea or spotting', 'time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction', 'bothersome bleeding', 'higher satisfaction']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306383', 'cui_str': 'Etonogestrel Drug Implant'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}]",112.0,0.624149,"Secondary outcomes included time to bleeding or spotting cessation and restart after first treatment, overall bleeding patterns, and satisfaction.
","[{'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon; the Department of Obstetrics and Gynecology, University of Hawaii, Honolulu, Hawaii; and the Department of Obstetrics & Gynecology, the Permanente Medical Group, San Leandro, California.'}, {'ForeName': 'Bliss', 'Initials': 'B', 'LastName': 'Kaneshiro', 'Affiliation': ''}, {'ForeName': 'Katharine B', 'Initials': 'KB', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hauschildt', 'Affiliation': ''}, {'ForeName': 'Kise', 'Initials': 'K', 'LastName': 'Bond', 'Affiliation': ''}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Boniface', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003896']
2514,32649494,Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.,"OBJECTIVE


To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures.
METHODS


Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups.
RESULTS


From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event.
CONCLUSION


Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates.
FUNDING SOURCE


Boston Scientific Corporation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02277925.",2020,"Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43).","['From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable', 'One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable']","['sacrocolpopexy with a light-weight polypropylene mesh', 'Absorbable Suture for Vaginal Mesh Fixation', 'delayed absorbable groups', 'permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy', 'Total Hysterectomy and Sacrocolpopexy']","['rate of mesh or permanent suture exposure', 'Composite success', 'composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment', 'serious adverse event', 'mesh or permanent suture exposure in the first year after surgery', 'total rate of mesh or permanent suture exposure']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",198.0,0.368163,"Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43).","[{'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Department of Urology, Wake Forest Baptist Health, Winston Salem, and the Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Augusta University, Augusta, Georgia; Northwestern Feinberg School of Medicine, Chicago, Illinois; and Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Geller', 'Affiliation': ''}, {'ForeName': 'Barbara R', 'Initials': 'BR', 'LastName': 'Henley', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': ''}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'Alexis A', 'Initials': 'AA', 'LastName': 'Dieter', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Parnell', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lewicky-Gaupp', 'Affiliation': ''}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003884']
2515,32649498,Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate differences in physical function at 6 weeks after vaginal surgery among women positioned in candy cane and boot stirrups.
METHODS


We conducted a single-masked, randomized controlled trial of women undergoing vaginal surgery with either candy cane or boot stirrup use. The primary outcome was a change in the PROMIS (Patient-Reported Outcomes Measurement Information System) physical function short form-20a from baseline to 6 weeks after surgery. To achieve 80% power to detect a moderate Cohen effect (d=0.5), we required 64 participants in each group.
RESULTS


From March 2018 to October 2019, 141 women were randomized, and 138 women (72 in the candy cane group and 66 in the boot stirrup group) were included in the final analysis. There were no baseline differences in participant characteristics including age, body mass index, comorbidities, or preoperative history of joint replacements. There were no between-group differences in surgery type, duration of surgery, estimated blood loss, or adverse events at 6 weeks postoperation. Participants in the candy cane group demonstrated worse physical function at 6 weeks compares with the improvement seen in those in the boot stirrup group; this was significantly different between groups (-1.9±7.9 candy cane vs 1.9±7.0 boot, P<.01).
CONCLUSION


Women undergoing vaginal surgery positioned in boot stirrups have significantly better physical function at 6 weeks after surgery when compared with women positioned in candy cane stirrups.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03446950.",2020,"There were no between-group differences in surgery type, duration of surgery, estimated blood loss, or adverse events at 6 weeks postoperation.","['women positioned in candy cane and boot stirrups', '64 participants in each group', 'From March 2018 to October 2019, 141 women were randomized, and 138 women (72 in the candy cane group and 66 in the boot stirrup group) were included in the final analysis', 'Women undergoing', 'Vaginal Surgery', 'women undergoing vaginal surgery with either']","['vaginal surgery positioned in boot stirrups', 'candy cane', 'Candy Cane', 'candy cane or boot stirrup use']","['surgery type, duration of surgery, estimated blood loss, or adverse events', 'worse physical function', 'physical function', 'change in the PROMIS (Patient-Reported Outcomes Measurement Information System) physical function short form-20a']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0038152', 'cui_str': 'Stapes structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0195117', 'cui_str': 'Operation on vagina'}]","[{'cui': 'C0195117', 'cui_str': 'Operation on vagina'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0038152', 'cui_str': 'Stapes structure'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",141.0,0.329057,"There were no between-group differences in surgery type, duration of surgery, estimated blood loss, or adverse events at 6 weeks postoperation.","[{'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics & Gynecology, and the Department of Obstetrics & Gynecology, University of Louisville School of Medicine, and the Department of Bioinformatics & Biostatistics, School of Public Health and Information Sciences, University of Louisville, Louisville, Kentucky; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, University of New Mexico, Albuquerque, New Mexico; and the Department of Obstetrics & Gynecology, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Meriwether', 'Affiliation': ''}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Tuller', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sekula', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Gaskins', 'Affiliation': ''}, {'ForeName': 'J Ryan', 'Initials': 'JR', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Deslyn', 'Initials': 'D', 'LastName': 'Hobson', 'Affiliation': ''}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Cardenas-Trowers', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Francis', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003954']
2516,32649584,The Effect of Interactive Educational Workshops With or Without Standardized Patients on the Clinical Skills of Midwifery Students in Providing Sexual Health Counseling.,"BACKGROUND AND OBJECTIVES


Insufficient skills among health personnel, including midwives, can lead to failure in evaluating and providing sexual health counseling services to clients. Thus, the purpose of this study was to compare the effect of 2 interactive educational workshops with or without standardized patients (SPs) on midwifery students' clinical skills in providing sexual health counseling at Mashhad University of Medical Sciences, Mashhad, Iran, in 2014 to 2015.
RESEARCH METHODS


In this randomized controlled trial, 62 midwifery students were selected through convenient sampling method and then randomly divided into 2 groups who received 1 of 2 interactive educational workshops, with or without SPs in 10-hour educational programs. The students' skills in providing sexual health counseling were evaluated before and 2 weeks after the education through an Objective Structured Clinical Examination composed of 5 stations using validated checklists. The data were then analyzed using the SPSS Software (Version 16) through descriptive statistics as well as independent t test, paired t test, Mann-Whitney U, χ, and Fisher exact tests. The level of significance was considered by P < 0.05.
RESULTS


There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77). However, 2 weeks after the interventions, the mean scores were 75.8 ± 11.2 and 47.0 ± 8.9, respectively, meaning a significant difference between the study groups (P < 0.0001).
CONCLUSIONS


Although both teaching methods could promote clinical skills among the midwifery students, the effect of interactive workshop with SPs was much significantly stronger.",2020,"There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77).","['Patients on the Clinical Skills of Midwifery Students in Providing Sexual Health Counseling', '62 midwifery students', ""midwifery students' clinical skills in providing sexual health counseling at Mashhad University of Medical Sciences, Mashhad, Iran, in 2014 to 2015""]","['Interactive Educational Workshops With or Without Standardized', '2 interactive educational workshops with or without standardized patients (SPs', '2 interactive educational workshops, with or without SPs in 10-hour educational programs']","[""mean scores of students' clinical skills in providing sexual health counseling services"", 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",62.0,0.0304016,"There was no significant difference between the mean scores of students' clinical skills in providing sexual health counseling services in the group educated with or without SPs (22.4 ± 7.0 and 23.0 ± 9.4, P = 0.77).","[{'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Khadivzadeh', 'Affiliation': 'From the Nursing and Midwifery Care Research Center (T.K.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; Department of Midwifery (M.A.S.S.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; Department of Midwifery (K.M.), School of Nursing and Midwifery, Mashhad University of Medical Sciences; and Department of Medical-Surgical Nursing (S.R.M.), School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Ardaghi Sefat Seighalani', 'Affiliation': ''}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Mirzaii', 'Affiliation': ''}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000439']
2517,32643326,Evaluation of the mechanical properties and clinical efficacy of biphasic calcium phosphate-added collagen membrane in ridge preservation.,"PURPOSE


This study aimed to evaluate the biocompatibility and the mechanical properties of ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes and to compare the clinical results of ridge preservation to those obtained using chemically cross-linked collagen membranes.
METHODS


The study comprised an  in vitro  test and a clinical trial for membrane evaluation. BCP-added collagen membranes with UV cross-linking were prepared. In the  in vitro  test, scanning electron microscopy, a collagenase assay, and a tensile strength test were performed. The clinical trial involved 14 patients undergoing a ridge preservation procedure. All participants were randomly divided into the test group, which received UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes (n=7). BCP bone substitutes were used for both the test group and the control group. Cone-beam computed tomography (CBCT) scans were performed and alginate impressions were taken 1 week and 3 months after surgery. The casts were scanned via an optical scanner to measure the volumetric changes. The results were analyzed using the nonparametric Mann-Whitney  U  test.
RESULTS


The fastest degradation rate was found in the collagen membranes without the addition of BCP. The highest enzyme resistance and the highest tensile strength were found when the collagen-to-BCP ratio was 1:1. There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
CONCLUSIONS


The addition of BCP and UV cross-linking improved the biocompatibility and the mechanical strength of the membranes. Within the limits of the clinical trial, the sites grafted using BCP in combination with UV cross-linked and BCP-added collagen membranes (test group) did not show any statistically significant difference in terms of dimensional change compared with the control group.",2020,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
",['14 patients undergoing a ridge preservation procedure'],"['Cone-beam computed tomography (CBCT) scans', 'UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes', 'ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes', 'biphasic calcium phosphate-added collagen membrane']","['dimensional change', 'highest enzyme resistance and the highest tensile strength', 'fastest degradation rate', '3-dimensional modeling or CBCT scans', 'dimensional changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",14.0,0.0258414,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
","[{'ForeName': 'Jung Tae', 'Initials': 'JT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul, Korea.'}, {'ForeName': 'Yoonsub', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Dajung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Sungtae', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea. kst72@snu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001080054']
2518,32643327,Effects of an electric toothbrush combined with 3-color light-emitting diodes on antiplaque and bleeding control: a randomized controlled study.,"PURPOSE


This randomized controlled study aimed to evaluate the effects of an electric toothbrush with 3 colors of light-emitting diodes (LEDs) on antiplaque and bleeding control.
METHODS


This randomized, placebo-controlled, double-blinded, parallel-group clinical trial included 50 healthy adults with gingivitis, who were randomly assigned to 2 groups. The experimental group used electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush as the experimental group, but with LED sources with one-hundredth of the strength. The subjects used the electric toothbrush 3 times a day for 4 minutes each time. As clinical indices, bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI) were assessed at baseline, at 3 weeks, and at 6 weeks.
RESULTS


There were significant decreases in all clinical indices (BOMP, GI, QHI) in both the experimental and control groups compared to baseline at 3 weeks and at 6 weeks. In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05). However, at 6 weeks, statistically significant differences were observed between the experimental and control groups in BOMP and GI, which are indicators of gingival inflammation ( P <0.05).
CONCLUSIONS


This study demonstrated that an electric toothbrush combined with 3-color LEDs reduced gingival bleeding and inflammation after 6 weeks.",2020,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).",['50 healthy adults with gingivitis'],"['electric toothbrush with 3 colors of light-emitting diodes (LEDs', 'electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush', 'electric toothbrush combined with 3-color LEDs', 'electric toothbrush combined with 3-color light-emitting diodes', 'placebo']","['gingival bleeding and inflammation', 'gingival inflammation', 'bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI', 'BOMP and GI', 'clinical indices (BOMP, GI, QHI', 'antiplaque and bleeding control']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}]",50.0,0.0547114,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).","[{'ForeName': 'Chakyoung', 'Initials': 'C', 'LastName': 'Kwon', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jae Mok', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jo Young', 'Initials': 'JY', 'LastName': 'Suh', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Seung Jun', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Youngkyun', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Biochemistry, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Yong Gun', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea. periokyg@knu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001800090']
2519,32643358,Efficacy of dexmedetomidine as an adjuvant to Quadratus lumborum block for paediatrics undergoing laparoscopic pyeloplasty. A prospective randomized double blinded study.,"BACKGROUND


We designed this study to evaluate dexmedetomidine as an adjuvant to local anesthetics in Quadratus lumborum block (QLB) in paediatrics either interfascial versus intravenous on the quality of postoperative analgesia and incidence of side effects.
METHODS


Fifty paediatric patients ASA I and II, from eight to thirteen years old posted for laparoscopic pyeloplasty were randomized either to: QLB dexmedetomidine intravenous (QD IV) group or QLB dexmedetomidine interfascial (QD IF) group. A 24 h postoperative morphine consumption (primary outcome), time to first analgesic request, postoperative pain and sedation scores were compared. The recovery time after anaesthesia and the incidences of intraoperative and postoperative hypotension or bradycardia were recorded.
RESULTS


The median [IQR] 24 h postoperative morphine consumption in QD IF group [0.05 (0.05 - 0.10) mg/kg] was lower compared with QD IV group [0.15 (0.10 - 0.20) mg/kg] (P ˂0.001). Longer time to first analgesic request was noted in QD IF group [505 (395 - 583) min] in comparison to QD IV group [306 (258 - 388) min] (P ˂ 0.001). Pain scores were lower in QD IF group at six and eight hours postoperatively. Sedation scores were lower in QD IF group on admission to PACU and two hours postoperatively. Intraoperative hypotension and bradycardia were lower in QD IF group. Longer recovery time in QD IV group.
CONCLUSIONS


Interfascial dexmedetomidine adjuvant to QLB provided better postoperative analgesia in terms of less morphine consumption, better pain scores and longer time to first analgesic request when compared with the IV dexmedetomidine.",2020,Longer time to first analgesic request was noted in QD IF group [505 (395 - 583) min] in comparison to QD IV group [306 (258 - 388) min] (P ˂ 0.001).,"['paediatrics undergoing laparoscopic pyeloplasty', 'Fifty paediatric patients ASA I and II, from eight to thirteen years old posted for']","['QLB', 'QLB dexmedetomidine intravenous (QD IV', 'dexmedetomidine interfascial (QD IF', 'laparoscopic pyeloplasty', 'dexmedetomidine']","['Intraoperative hypotension and bradycardia', 'pain scores', 'Longer recovery time', 'median [IQR] 24 h postoperative morphine consumption', 'time to first analgesic request, postoperative pain and sedation scores', 'Sedation scores', 'recovery time after anaesthesia and the incidences of intraoperative and postoperative hypotension or bradycardia', 'postoperative analgesia', 'Longer time to first analgesic request', 'Pain scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",50.0,0.133798,Longer time to first analgesic request was noted in QD IF group [505 (395 - 583) min] in comparison to QD IV group [306 (258 - 388) min] (P ˂ 0.001).,"[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Kasem', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Bestarous', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Toaima', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Ali', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shokri', 'Affiliation': 'Department of Anaesthesiology, Ain Shams University, Cairo, Egypt - Drhoda10@yahoo.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14298-6']
2520,32643359,Hands-free induction of general anaesthesia: a randomised pilot study comparing usual care and high-flow nasal oxygen.,"BACKGROUND


The induction of general anaesthesia is preceded by face mask preoxygenation and oxygen delivery during intubation (peroxygenation). High-flow nasal oxygen (HFNO) may be an effective alternative.
METHODS


In this multicentre randomized controlled study, adults undergoing general anaesthesia with oral intubation were included, provided written consent, and were assigned to the control group (face mask) or experimental group (HFNO). The primary objective was to validate HFNO as a safe and efficient technique for preoxygenation and peroxygenation. The main outcome was the risk of oxygen desaturation (SpO2 ≤ 92%). Analysis was performed with the intention-to-treat principle.
RESULTS


Among 68 eligible patients, 61 completed the study (31 in the face mask group and 30 in the HFNO group). The patient characteristics were comparable between groups. A decrease in SpO2 was observed in the HFNO group (p=0.491). Oesophageal intubation at the first attempt occurred twice in the HFNO group, with no oxygen desaturation, and never occurred in the face mask group (p=0.238). There was no difference in airway management or haemodynamic recordings between the groups. The end-tidal CO2 levels at intubation were similar between the groups: 5.1 [4.7-5.7] kPa in the face mask group vs 5.2 [4.8-6.0] kPa in the HFNO group (p=0.292). HFNO was preferred by the investigators (p=0.003) and patients, with improved comfort (p=0.018), less submandibular pain (p=0.003), and a similar severity of hoarseness (p=0.686).
CONCLUSIONS


HFNO provides a hands-free induction of general anaesthesia and yields adequate preoxygenation and peroxygenation, with a significant improvement in the quality of care.",2020,"HFNO was preferred by the investigators (p=0.003) and patients, with improved comfort (p=0.018), less submandibular pain (p=0.003), and a similar severity of hoarseness (p=0.686).
","['68 eligible patients, 61 completed the study (31 in the face mask group and 30 in the HFNO group', 'Hands-free induction of general anaesthesia', 'adults undergoing general anaesthesia with oral intubation']","['High-flow nasal oxygen (HFNO', 'control group (face mask) or experimental group (HFNO', 'usual care and high-flow nasal oxygen']","['HFNO', 'SpO2', 'airway management or haemodynamic recordings', 'end-tidal CO2 levels', 'quality of care', 'risk of oxygen desaturation', 'submandibular pain', 'Oesophageal intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}]",68.0,0.0511887,"HFNO was preferred by the investigators (p=0.003) and patients, with improved comfort (p=0.018), less submandibular pain (p=0.003), and a similar severity of hoarseness (p=0.686).
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tremey', 'Affiliation': 'Department of Anaesthesiology, Centre Médico-Chirurgical Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Squara', 'Affiliation': 'Research Unit, Centre Médico-Chirurgical Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'De Labarre', 'Affiliation': 'Department of Anaesthesiology, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Anaesthesiology, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anaesthesiology, Hôpital Foch, Suresnes, France - m.fischler@hopital-foch.org.'}, {'ForeName': 'Jean-Dominique', 'Initials': 'JD', 'LastName': 'Lawkoune', 'Affiliation': 'Department of Anaesthesiology, Centre Médico-Chirurgical Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anaesthesiology, Hôpital Foch, Suresnes, France.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14456-0']
2521,32643385,"Peer engagement in toddlers with autism: Community implementation of dyadic and individual Joint Attention, Symbolic Play, Engagement, and Regulation intervention.","LAY ABSTRACT


Although young children may participate in education and intervention programs that take place in classrooms or groups, there is little information about how toddlers with special needs, and specifically toddlers with autism, are engaging with their peers. This study takes place in a public center-based early intervention program for toddlers with autism. Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer. Children in both groups made gains in social communication and play skills. Children who had the peer intervention were more engaged with peers when an adult was present, but not when the children were unsupported. This article adds information about early skills that may be important for children to master so that they have more success when trying to interact with their peers. These skills include understanding language (referred to as ""receptive language"" at 12 months or more) and play skills including building and stacking (referred to as ""combination play""-for example, building with blocks or completing a puzzle) and extending familiar actions to themselves, others, and figures (referred to as ""presymbolic play""-for example, putting a bottle to the doll or to themselves). Understanding which skills to target can help practitioners focus their instruction to build children's skills toward connecting with peers through play.",2020,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"['Classrooms of toddlers', 'young children', 'toddlers with autism']",['individual social communication intervention or the same intervention adapted to include a peer'],['social communication and play skills'],"[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",,0.0213406,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"[{'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Shire', 'Affiliation': 'University of Oregon, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bracaglia', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kodjoe', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California, Los Angeles, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320935689']
2522,32643454,Efficacy of intradermal minoxidil 5% injections for treatment of patchy non-severe alopecia areata.,"Background:  Intradermal minoxidil is used as an off-label treatment for patchy non-severe alopecia areata (AA) either alone or in combination with steroids; however, studies estimating its efficacy are still lacking. Objectives:  To assess the efficacy of intradermal delivery of minoxidil 5% alone and in combination with intralesional triamcinolone acetonide for treatment of patchy non-severe AA. Patients and Methods : One hundred patches in twenty patients with patchy non-severe AA, five patches for each patient, were included in this prospective intra-patient comparative controlled clinical study. Four comparative patches per each patient were randomly assigned to receive 4 sessions, at a 4-week interval, of one of the following treatments: intralesional triamcinolone acetonide, intralesional minoxidil 5%, combination treatment, or micro-needling. The fifth patch was observed as the negative control. Treatment outcomes were assessed at baseline, and one month after treatment end. Results:  Minoxidil intradermal injection was nearly comparable to the micro-needling effect and its combination to steroids had no additive effect. Hair regrowth in response to minoxidil occurred earlier than the spontaneous recovery. Conclusion:  Monotherapy of intralesional minoxidil is of a limited efficacy in treating non-severe patchy AA, but it speeds the recovery.",2020,Minoxidil intradermal injection was nearly comparable to the micro-needling effect and its combination to steroids had no additive effect.,"['patchy non-severe alopecia areata (AA', 'One hundred patches in twenty patients with patchy non-severe AA, five patches for each patient', 'patchy non-severe alopecia areata', 'patchy non-severe AA', 'Patients and Methods ']","['minoxidil', 'intralesional triamcinolone acetonide, intralesional minoxidil 5%, combination treatment, or micro-needling', 'Minoxidil intradermal injection', 'intralesional minoxidil', 'intradermal minoxidil', 'intralesional triamcinolone acetonide']",[],"[{'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}]",[],20.0,0.0286038,Minoxidil intradermal injection was nearly comparable to the micro-needling effect and its combination to steroids had no additive effect.,"[{'ForeName': 'Mahmoud Abd El-Rahim', 'Initials': 'MAE', 'LastName': 'Abdallah', 'Affiliation': 'Department and institution, Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Shareef', 'Affiliation': 'Department and institution, Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Marwa Y', 'Initials': 'MY', 'LastName': 'Soltan', 'Affiliation': 'Department and institution, Department of Dermatology and Venereology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1793893']
2523,32643490,Anxiety Sensitivity and Panic Disorder: Evaluation of the Impact of Cognitive-Behavioral Group Therapy.,"Anxiety sensitivity (AS) is a multidimensional construct associated with the etiology and maintenance of panic disorder (PD) symptoms. However, only a few studies have evaluated whether cognitive-behavioral group therapy (CBGT) can modify the condition. The objective of this study was to evaluate the impact of CBGT on AS in patients with PD and to analyze AS and its dimensions as predictors of response to CBGT. In the present clinical trial, an intervention group ( n  = 37) attended 12 CBGT sessions, while a control group ( n  = 52) did not receive any intervention. The severity of symptoms and of AS were evaluated before and after CBGT in the intervention group and once in the control group. Significant improvement occurred in all specific PD symptoms and in general anxiety and depressive symptoms. Furthermore, AS scores reduced significantly after intervention. This study confirmed that AS is higher in patients with more severe PD. The effectiveness of CBGT for reducing the physical, cognitive, and social dimensions of AS was also observed, supporting the hypothesis of a positive impact of therapy.",2020,The severity of symptoms and of AS were evaluated before and after CBGT in the intervention group and once in the control group.,"['patients with more severe PD', 'patients with PD']","['CBGT sessions, while a control group ( n \u2009=\u200952) did not receive any intervention', 'Cognitive-Behavioral Group Therapy', 'CBGT', 'cognitive-behavioral group therapy (CBGT']","['Anxiety sensitivity (AS', 'severity of symptoms and of AS', 'general anxiety and depressive symptoms', 'specific PD symptoms', 'Anxiety Sensitivity and Panic Disorder']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0247918,The severity of symptoms and of AS were evaluated before and after CBGT in the intervention group and once in the control group.,"[{'ForeName': 'Andressa da Silva', 'Initials': 'ADS', 'LastName': 'Behenck', 'Affiliation': 'School of Nursing, Federal University of Rio Grande do Sul (UFRGS) and Anxiety Disorders Program of Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Wesner', 'Affiliation': 'Federal University of Health Sciences of Porto Alegre (UFCSPA) and Anxiety Disorders Program of Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Luciano Santos Pinto', 'Initials': 'LSP', 'LastName': 'Guimaraes', 'Affiliation': 'Research and Graduate Group, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Gisele Gus', 'Initials': 'GG', 'LastName': 'Manfro', 'Affiliation': 'Federal University of Rio Grande do Sul (UFRGS) and Anxiety Disorders Program of Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Carolina Blaya', 'Initials': 'CB', 'LastName': 'Dreher', 'Affiliation': 'Federal University of Rio Grande do Sul (UFRGS), Anxiety Disorders Program of Hospital de Clínicas de Porto Alegre and Graduation in Medicine of Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Elizeth', 'Initials': 'E', 'LastName': 'Heldt', 'Affiliation': 'School of Nursing, Federal University of Rio Grande do Sul (UFRGS) and Anxiety Disorders Program of Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1780527']
2524,32643500,Delayed Granulocyte Colony-Stimulating Factor (G-CSF) Administration after Chemotherapy Reduces Total G-CSF Doses without Affecting Neutrophil Recovery in a Randomized Clinical Study in Children with Solid Tumors.,"The use of G-CSF after myelotoxic chemotherapy accelerates neutrophil recovery reducing the risk of febrile neutropenia. Current guidelines recommend initiating G-CSF 24 hours after myelotoxic chemotherapy. However, the optimal timing of post-chemotherapy G-CSF administration has not been elucidated. Our previous work in murine models demonstrated that the reappearance of myeloid progenitors does not occur in bone marrow until 3-4 days after completion of chemotherapy suggesting that delayed G-CSF administration may be equally efficacious compared to current practice. We conducted a prospective, randomized, crossover study to compare the absolute neutrophil count (ANC) recovery after chemotherapy and a delayed G-CSF administration to a standard G-CSF administration schedule with early G-CSF start. A total of 21 children with solid tumors who received 2 identical cycles of myelotoxic chemotherapy were randomized to start receiving G-CSF either 24 hours after completion of chemotherapy or on the day that their ANC dropped below 1,000/mm 3 . There was no significant difference in the time to neutrophil recovery (ANC > 1,000/mm 3  post nadir) between the two G-CSF administration schedules: 16.0 ± 0.5 days in the standard group compared to 16.7 ± 0.4 days in the delayed group (p = 0.36). The total number of G-CSF doses given, however, was significantly less in the delayed group: 6.7 ± 0.6 compared to 10.5 ± 0.6 doses in the standard group (p < 0.0001). Our data show that a delayed administration of post chemotherapy G-CSF resulted in a significant reduction in the number of G-CSF injections without compromising the G-CSF effects on neutrophil recovery.",2020,"There was no significant difference in the time to neutrophil recovery (ANC > 1,000/mm 3  post nadir) between the two G-CSF administration schedules: 16.0 ± 0.5 days in the standard group compared to 16.7 ± 0.4 days in the delayed group (p = 0.36).","['Children with Solid Tumors', '21 children with solid tumors who received 2 identical cycles of']","['Delayed Granulocyte Colony-Stimulating Factor (G-CSF', 'myelotoxic chemotherapy']","['febrile neutropenia', 'time to neutrophil recovery', 'neutrophil recovery', 'absolute neutrophil count (ANC) recovery', 'number of G-CSF injections', 'total number of G-CSF doses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",21.0,0.0300667,"There was no significant difference in the time to neutrophil recovery (ANC > 1,000/mm 3  post nadir) between the two G-CSF administration schedules: 16.0 ± 0.5 days in the standard group compared to 16.7 ± 0.4 days in the delayed group (p = 0.36).","[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Yankelevich', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hoogstra', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'Biostatistics Core, Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chu', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Bhambhani', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Taub', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.'}]",Pediatric hematology and oncology,['10.1080/08880018.2020.1779885']
2525,32643543,Group Hypnosis for Stress Reduction - A Feasibility Study.,"The aim of this study was to develop a standardized hypnotherapeutic group program for stress reduction, test its feasibility, and measure its preliminary pre- to postintervention effects. In this prospective, single-arm feasibility study, healthy adult participants with self-assessed increased stress levels received 5 weekly group hypnosis sessions plus audio recordings. Twelve persons (10 females, mean (SD) age 48.9 (11.8) years participated. The mean (SD) intensity of perceived stress on a 0-to-100 mm VAS was reduced from 75.5 (11.5) mm at baseline to 33.9 (18.8) mm after 5 weeks. Cohen's perceived stress scale was reduced from 20.8 (5.7) to 13.8 (5.4). Focus group interviews showed that the study intervention was feasible and well accepted. Confirmatory testing of the intervention in a randomized controlled trial is necessary.",2020,Cohen's perceived stress scale was reduced from 20.8 (5.7) to 13.8 (5.4).,"['Twelve persons (10 females, mean (SD) age 48.9 (11.8) years participated', 'healthy adult participants with self-assessed increased stress levels']",['hypnosis sessions plus audio recordings'],"['mean (SD) intensity of perceived stress on a 0-to-100 mm VAS', 'stress scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0257359,Cohen's perceived stress scale was reduced from 20.8 (5.7) to 13.8 (5.4).,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Fisch', 'Affiliation': 'Psychotherapeutische Praxis , Coesfeld, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Binting', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité Universitätsmedizin Berlin , Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité Universitätsmedizin Berlin , Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Cree', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité Universitätsmedizin Berlin , Germany.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Brinkhaus', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité Universitätsmedizin Berlin , Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teut', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité Universitätsmedizin Berlin , Germany.'}]",The International journal of clinical and experimental hypnosis,['10.1080/00207144.2020.1781537']
2526,32643885,[Effect of Baixiao moxibustion at meridian sinew nodal points on upper limb motor function in children with spastic hemiplegic cerebral palsy].,"OBJECTIVE


To investigate the effect of Baixiao moxibustion at meridian sinew nodal points combined with routine rehabilitation on upper limb motor function in children with spastic hemiplegic cerebral palsy.
METHODS


A total of 50 children with spastic hemiplegic cerebral palsy were divided into control group and treatment group using a random number table, with 25 children in each group. The children in the control group were given routine rehabilitation training of the ipsilateral upper and lower limbs, and those in the treatment group were given Baixiao moxibustion at the meridian sinew nodal points of the ipsilateral upper limb in addition to the treatment in the control group, once a day and five times a week. Each course of treatment was 4 consecutive weeks, and both groups were treated for 3 courses. Before treatment and at weeks 4 and 12 of treatment, modified Ashworth score was used to evaluate muscle tension of the ipsilateral upper limb, and 88-item version of the Gross Motor Function Measure (GMFM-88) and Carroll upper extremities functional test (UEFT) were used to assess the motor function of the ipsilateral upper limb.
RESULTS


At weeks 4 and 12 of treatment, both groups had a significant reduction in modified Ashworth score ( P <0.05) and significant increases in GMFM-88 and UEFT scores ( P <0.05). Both groups had significant changes in modified Ashworth score, GMFM-88 score, and UEFT score from week 4 to week 12 of treatment ( P <0.05). Compared with the control group at week 12 of treatment, the treatment group had a significant reduction in modified Ashworth score ( P <0.05) and significant increases in GMFM-88 and UEFT scores ( P <0.05).
CONCLUSION


Baixiao moxibustion at meridian sinew nodal points can significantly improve the muscle tension and motor function of the ipsilateral upper limb in children with spastic hemiplegic cerebral palsy, and the improvement becomes more apparent as the treatment lasts longer.",2020,"Compared with the control group at week 12 of treatment, the treatment group had a significant reduction in modified Ashworth score ( P <0.05) and significant increases in GMFM-88 and UEFT scores ( P <0.05).
","['50 children with spastic hemiplegic cerebral palsy', 'children with spastic hemiplegic cerebral palsy']","['routine rehabilitation training', 'routine rehabilitation', 'Baixiao moxibustion']","['muscle tension and motor function', 'modified Ashworth score', 'GMFM-88 and UEFT scores', 'muscle tension of the ipsilateral upper limb, and 88-item version of the Gross Motor Function Measure (GMFM-88) and Carroll upper extremities functional test (UEFT', 'modified Ashworth score, GMFM-88 score, and UEFT score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",50.0,0.0178902,"Compared with the control group at week 12 of treatment, the treatment group had a significant reduction in modified Ashworth score ( P <0.05) and significant increases in GMFM-88 and UEFT scores ( P <0.05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Liu', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Fei-Fei', 'Initials': 'FF', 'LastName': 'Chen', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Su-Fen', 'Initials': 'SF', 'LastName': 'Zhao', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}, {'ForeName': 'Pao-Qiu', 'Initials': 'PQ', 'LastName': 'Wang', 'Affiliation': ""Third Department of Rehabilitation, Hunan Children's Hospital, Changsha 410007, China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190585']
2527,32643886,[Clinical effect of thunder-fire moxibustion combined with electroacupuncture in the treatment of cold-dampness knee osteoarthritis: a randomized controlled trial].,"OBJECTIVE


To investigate the clinical effect of thunder-fire moxibustion combined with electroacupuncture in the treatment of cold-dampness knee osteoarthritis.
METHODS


A total of 72 patients with cold-dampness knee osteoarthritis were randomly divided into observation group and control group according to the random numbers generated by computer software, with 36 patients in each group. For the observation group, electroacupuncture was performed at the main acupoints of Dubi (ST35), Neixiyan (EX-LE4), Zusanli (ST36), Yanglingquan (GB34), Yinlingquan (SP9), Xuehai (SP10), Liangqiu (ST34), and Heding (EX-LE2) once a day, with a needle retaining time of 30 min, and thunder-fire moxibustion was performed at Shenque (CV8) and Guanyuan (CV4) in the form of suspended moxibustion once a day, with 30 min each time. The patients in the control group were given oral administration of diclofenac sodium double-release enteric-coated capsules, 75 mg each time, once a day, and Fugui Gutong capsules, 6 capsules a time and 3 times a day. Each course of treatment was 14 days, and both groups were treated for 2 courses, with an interval of 2 days between the two courses. Visual Analogue Scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and Lequesne index were observed before the treatment, immediately after the treatment, and at 4 months after the treatment, and the outcome of traditional Chinese medicine (TCM) syndrome was compared between the two groups after treatment.
RESULTS


Both groups had significant reductions in VAS score, WOMAC score, and Lequesne index immediately and at 4 months after the treatment ( P <0.05). Compared with the control group, the observation group had significant reductions in VAS score, Lequesne index, and WOMAC score (scores of pain, function and total score) immediately and at 4 months after the treatment ( P <0.05). The effective rate was 97.1% (34/35) in the observation group, and was 78.8% (26/33) in the control group. The effective rate of the observation group was obviously higher than that of the control group ( P <0.05).
CONCLUSION


Thunder-fire moxibustion combined with electroacupuncture has a better, more durable clinical effect and fewer adverse reactions than the drugs in the treatment of cold-dampness knee osteoarthritis.",2020,"Both groups had significant reductions in VAS score, WOMAC score, and Lequesne index immediately and at 4 months after the treatment ( P <0.05).","['72 patients with cold-dampness knee osteoarthritis', 'cold-dampness knee osteoarthritis']","['electroacupuncture', 'diclofenac sodium double-release enteric-coated capsules', 'thunder-fire moxibustion combined with electroacupuncture']","['Visual Analogue Scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and', 'traditional Chinese medicine (TCM) syndrome', 'Dubi (ST35), Neixiyan (EX-LE4), Zusanli (ST36), Yanglingquan (GB34), Yinlingquan (SP9), Xuehai (SP10), Liangqiu (ST34), and Heding (EX-LE2', 'adverse reactions', 'Lequesne index', 'effective rate', 'VAS score, WOMAC score, and Lequesne index', 'VAS score, Lequesne index, and WOMAC score (scores of pain, function and total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0991569', 'cui_str': 'Delayed Release Oral Capsule'}, {'cui': 'C0450043', 'cui_str': 'Thunder'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",72.0,0.0347847,"Both groups had significant reductions in VAS score, WOMAC score, and Lequesne index immediately and at 4 months after the treatment ( P <0.05).","[{'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Deng', 'Affiliation': 'Guangxi University of Chinese Medicine, Nanning 530001, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011.'}, {'ForeName': 'Sheng-Wang', 'Initials': 'SW', 'LastName': 'Zhu', 'Affiliation': 'Guangxi University of Chinese Medicine, Nanning 530001, China.'}, {'ForeName': 'Xing-Cheng', 'Initials': 'XC', 'LastName': 'Wei', 'Affiliation': 'Guangxi University of Chinese Medicine, Nanning 530001, China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Zhang', 'Affiliation': 'Guangxi University of Chinese Medicine, Nanning 530001, China.'}, {'ForeName': 'Zi-Long', 'Initials': 'ZL', 'LastName': 'Liao', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011.'}, {'ForeName': 'Ri-Lan', 'Initials': 'RL', 'LastName': 'Chen', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190682']
2528,32643966,Strengthening the interpretability of clinical trial results by assessing the effect of informative censoring on the primary estimand in PRECISION.,"BACKGROUND


The ICH E9(R1) addendum states that the strategy to account for intercurrent events should be included when defining an estimand, the treatment effect to be estimated based on the study objective. The estimator used to assess the treatment effect needs to be aligned with the estimand that accounted for intercurrent events. Regardless of the strategy, missing data resulting from patient premature withdrawal could undermine the robustness of the study results. Informative censoring due to dropouts in an events-based study is one such example. Sensitivity analyses using imputation methods are useful to examine the uncertainty due to informative censoring and address the robustness and strength of the study results.
METHODS


We assessed the effect of premature patient withdrawal in the PRECISION study, a randomized non-inferiority clinical trial of patients with chronic arthritic pain that compared the cardiovascular safety of three nonsteroidal anti-inflammatory drugs-based treatment policies or paradigms. The protocol-defined use of concomitant or rescue medications was permitted since changes in pain medications due to insufficient analgesia were expected in patients in this long-term study. Anticipating that premature study discontinuations could potentially lead to informative censoring, a supplementary analysis was pre-specified in which censored outcomes due to the premature study discontinuation were imputed based on adverse events that were clinically associated with the primary endpoint (cardiovascular outcome based on the Antiplatelet Trialists Collaboration composite endpoint). Furthermore, tipping point analyses were conducted to test the robustness of the primary analysis results by assuming data censored not at random. The level of increase at which the primary study conclusion would change was estimated.
RESULTS


For the analysis of time to first primary endpoint event through 30 months, 4065 out of the 24,081 enrolled patients were lost to follow-up, withdrew consent, or were no longer willing to participate in the study. These withdrawals occurred gradually and resulted in a cumulative total of 5893 censored patient-years of observation (10.2%). The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups. The non-inferiority conclusion from the primary analysis was confirmed in the supplementary analysis incorporating relevant adverse events. Furthermore, tipping point analyses demonstrated that in order to lose non-inferiority in the primary analysis, the risk of primary endpoint events during the censored observation time would have to increase by more than 2.7-fold in the celecoxib group while remaining constant in the other nonsteroidal anti-inflammatory drugs groups, demonstrating that the scenarios where the study results are invalid appear not plausible.
CONCLUSIONS


Supplementary and sensitivity analyses presented to address informative censoring in PRECISION helped to further interpret and strengthen the study results.",2020,The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups.,['patients with chronic arthritic pain'],['celecoxib'],['rate of discontinuation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}]",24081.0,0.0492784,The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups.,"[{'ForeName': 'Weihang', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaffney', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Pressler', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Fayyad', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Wisemandle', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Beckerman', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520934747']
2529,32644104,Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer: A Post Hoc Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.,"Importance


Despite numerous published phase 3 trials, the association of treatment adherence with outcomes for patients with rectal cancer remains largely unexplored.
Objective


To analyze the association of treatment adherence with disease-free survival (DFS) among patients with rectal cancer in the CAO/ARO/AIO-04 trial.
Design, Setting, and Participants


This post hoc analysis of a phase 3 randomized clinical trial was conducted from July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma. Statistical analysis was performed from May 5, 2019, to February 2, 2020.
Interventions


A total of 625 patients received neoadjuvant fluorouracil-based chemoradiotherapy (nCRT), and a total of 607 patients received fluorouracil-based nCRT with addition of oxaliplatin. Of the 1126 patients who underwent curative surgery, 439 started fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin.
Main Outcomes and Measures


The association of adherence with nCRT and adjuvant chemotherapy with DFS was assessed in both groups in the as-treated population.
Results


Among the 625 patients (442 men; mean age, 63.0 years) who received fluorouracil nCRT and the 607 patients (430 men; mean age, 63.0 years) who received fluorouracil-based nCRT with addition of oxaliplatin, after a median follow-up of 50 months (interquartile range, 38-61 months), 3-year DFS in the as-treated population was 71.1% in the fluorouracil group and 75.8% in the fluorouracil-oxaliplatin group (hazard ratio [HR], 0.803; 95% CI, 0.651-0.990; P = .04). Overall, 419 patients in the fluorouracil nCRT group (67.0%) and 434 patients in the fluorouracil-oxaliplatin nCRT group (71.5%) received full doses of preoperative nCRT. Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the fluorouracil-oxaliplatin group (32.0%) received full doses of adjuvant chemotherapy. Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses. In contrast, adjuvant chemotherapy was not associated with DFS in both the fluorouracil group (complete vs near complete: HR, 0.900; 95% CI, 0.559-1.448; P = .66; complete vs incomplete: HR, 1.057; 95% CI, 0.807-1.386; P = .69) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.155; 95% CI, 0.716-1.866; P = .56; complete vs incomplete: HR, 1.073; 95% CI, 0.790-1,457; P = .65).
Conclusions and Relevance


To our knowledge, this is the first analysis of a phase 3 trial to assess the association of treatment adherence with some clinical outcomes for patients with rectal cancer. The findings emphasize the need for appropriate trial design with optimized nCRT dose and schedule and supportive strategies to facilitate good adherence and precision delivery, especially for intensified nCRT.
Trial Registration


ClinicalTrials.gov Identifier: NCT00349076.",2020,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","['patients with rectal cancer in the CAO/ARO/AIO-04 trial', '625 patients (442 men; mean age, 63.0 years) who received', 'patients with rectal cancer', '419 patients in the', 'July 25, 2006, to February 26, 2010, among 1232 patients from 80 centers with T3 to T4 or node-positive rectal adenocarcinoma', 'Patients With Rectal Cancer', 'Likewise, 253 of 439 patients in the fluorouracil group (57.6%) and 134 of 419 patients in the', '1126 patients who underwent curative surgery, 439 started', '625 patients received', 'and the 607 patients (430 men; mean age, 63.0 years) who received']","['fluorouracil-based nCRT with addition of oxaliplatin', 'fluorouracil-based adjuvant chemotherapy and 419 started fluorouracil-based adjuvant chemotherapy with oxaliplatin', 'fluorouracil-oxaliplatin', 'fluorouracil-oxaliplatin nCRT', 'fluorouracil', 'adjuvant chemotherapy', 'fluorouracil nCRT', 'neoadjuvant fluorouracil-based chemoradiotherapy (nCRT']","['association of adherence with nCRT and adjuvant chemotherapy with DFS', '3-year DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",625.0,0.204208,"Adherence to nCRT was associated with 3-year DFS in both the fluorouracil group (complete vs near complete: HR, 1.325; 95% CI, 0.959-1.832; P = .09; complete vs reduced: HR, 1.877; 95% CI, 1.147-3.072; P = .01) and the fluorouracil-oxaliplatin group (complete vs near complete: HR, 1.501; 95% CI, 0.980-2.299; P = .06; complete vs reduced: HR, 1.724; 95% CI, 1.144-2.596; P = .009) in multivariable analyses.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Diefenhardt', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Ethan B', 'Initials': 'EB', 'LastName': 'Ludmir', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Department of Medical Oncology, University Hospital Mannheim, University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral, and Pediatric Surgery, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Minsky', 'Affiliation': 'Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2394']
2530,32644110,Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial.,"Importance


A significant proportion of patients with early-stage triple-negative breast cancer (TNBC) are treated with neoadjuvant chemotherapy. Sequencing of circulating tumor DNA (ctDNA) after surgery, along with enumeration of circulating tumor cells (CTCs), may be used to detect minimal residual disease and assess which patients may experience disease recurrence.
Objective


To determine whether the presence of ctDNA and CTCs after neoadjuvant chemotherapy in patients with early-stage TNBC is independently associated with recurrence and clinical outcomes.
Design, Setting, and Participants


A preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice. Patients had blood samples collected for ctDNA and CTCs at time of treatment assignment; ctDNA analysis with survival was performed for 142 patients, and CTC analysis with survival was performed for 123 patients. Median clinical follow-up was 17.2 months (range, 0.3-58.3 months).
Interventions


Circulating tumor DNA was sequenced using the FoundationACT or FoundationOneLiquid Assay, and CTCs were enumerated using an epithelial cell adhesion molecule-based, positive-selection microfluidic device.
Main Outcomes and Measures


Primary outcomes were distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS).
Results


Among 196 female patients (mean [SD] age, 49.6 [11.1] years), detection of ctDNA was significantly associated with inferior DDFS (median DDFS, 32.5 months vs not reached; hazard ratio [HR], 2.99; 95% CI, 1.38-6.48; P = .006). At 24 months, DDFS probability was 56% for ctDNA-positive patients compared with 81% for ctDNA-negative patients. Detection of ctDNA was similarly associated with inferior DFS (HR, 2.67; 95% CI, 1.28-5.57; P = .009) and inferior OS (HR, 4.16; 95% CI,1.66-10.42; P = .002). The combination of ctDNA and CTCs provided additional information for increased sensitivity and discriminatory capacity. Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009). At 24 months, DDFS probability was 52% for patients who were ctDNA positive and CTC positive compared with 89% for those who were ctDNA negative and CTC negative. Similar trends were observed for DFS (HR, 3.15; 95% CI, 1.07-9.27; P = .04) and OS (HR, 8.60; 95% CI, 1.78-41.47; P = .007).
Conclusions and Relevance


In this preplanned secondary analysis of a randomized clinical trial, detection of ctDNA and CTCs in patients with early-stage TNBC after neoadjuvant chemotherapy was independently associated with disease recurrence, which represents an important stratification factor for future postneoadjuvant trials.
Trial Registration


ClinicalTrials.gov Identifier: NCT02101385.",2020,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","['With Triple-Negative Breast Cancer', 'Patients', 'patients with early-stage TNBC', 'patients with early-stage TNBC after', '196 female patients (mean [SD] age, 49.6 [11.1] years', 'Participants\n\n\nA preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive postneoadjuvant genomically directed therapy vs treatment of physician choice', 'patients with early-stage triple-negative breast cancer (TNBC']",['neoadjuvant chemotherapy'],"['DDFS probability', 'inferior DDFS', 'Circulating Tumor DNA and Circulating Tumor Cells', 'distant disease-free survival (DDFS), disease-free survival (DFS), and overall survival (OS']","[{'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",196.0,0.30666,"Patients who were ctDNA positive and CTC positive had significantly inferior DDFS compared with those who were ctDNA negative and CTC negative (median DDFS, 32.5 months vs not reached; HR, 5.29; 95% CI, 1.50-18.62; P = .009).","[{'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Radovich', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Guanglong', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Hancock', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chitambar', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Filipa C', 'Initials': 'FC', 'LastName': 'Lynce', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Blaya', 'Affiliation': 'Memorial Healthcare System, Hollywood, Florida.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Walling', 'Affiliation': 'Community Regional Cancer Care, Indianapolis, Indiana.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Daily', 'Affiliation': 'University of Florida, Gainesville.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Mahtani', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Advocate Aurora Health Care, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Erlanger Health System, Chattanooga, Tennessee.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Dean C', 'Initials': 'DC', 'LastName': 'Pavlick', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Albacker', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gregg', 'Affiliation': 'Foundation Medicine Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Solzak', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Bales', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Cantor', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Anna Maria V', 'Initials': 'AMV', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Badve', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Savran', 'Affiliation': 'Purdue University School of Mechanical Engineering, West Lafayette, Indiana.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2295']
2531,30556110,Population Pharmacokinetics of the BTK Inhibitor Acalabrutinib and its Active Metabolite in Healthy Volunteers and Patients with B-Cell Malignancies.,"INTRODUCTION


Bruton tyrosine kinase (BTK) is a key component of B-cell receptor signalling, critical for cell proliferation. Acalabrutinib, a selective, covalent BTK inhibitor, recently received an accelerated approval in relapsed/refractory mantle cell lymphoma. This analysis characterized the population pharmacokinetics (PK) of acalabrutinib and its metabolite ACP-5862.
METHODS


Data were obtained from six phase I/II trials in adult patients with B-cell malignancy and seven phase I trials in healthy volunteers. Pooled concentration-time data, at dose levels ranging from 15 to 400 mg, were analysed using non-linear mixed-effects modelling. Base model parameters were scaled with body weight and normalized to 70 kg (fixed exponents: 0.75 and 1 for clearance and volumes, respectively). A full covariate approach was used to evaluate any relevant effects of dose, health group/disease status, hepatic and renal impairment, use of acid-reducing agents, race and sex.
RESULTS


A total of 11,196 acalabrutinib and 1068 ACP-5862 concentration-time samples were available. The PK of both analytes were well described using two-compartment disposition models. Acalabrutinib absorption was characterized using sequential zero- and first-order constants and a lag time. Apparent clearance (CL/F) of acalabrutinib was 169 L/h (95% CI 159-175). Relative to the 100 mg dose group, the 15 and 400 mg dose groups showed a 1.44-fold higher and 0.77-fold lower CL/F, respectively. The clearance for ACP-5862 was 21.9 L/h (95% CI 19.5-24.0). The fraction metabolized was fixed to 0.4. The central and peripheral volumes of distribution were 33.1 L (95% CI 24.4-41.0) and 226 L (95% CI 149-305) for acalabrutinib, and 38.5 L (95% CI 31.6-49.2) and 38.4 L (95% CI 32.3-47.9) for ACP-5862. None of the investigated covariates led to clinically meaningful changes in exposure.
CONCLUSION


The PK of acalabrutinib and its metabolite ACP-5862 were adequately characterized. Acalabrutinib CL/F decreased with increasing dose, but the trend was small over the 75-250 mg range. No dose adjustment was necessary for intrinsic or extrinsic covariates.",2019,"Relative to the 100 mg dose group, the 15 and 400 mg dose groups showed a 1.44-fold higher and 0.77-fold lower CL/F, respectively.","['adult patients with B-cell malignancy and seven phase I trials in healthy volunteers', 'Healthy Volunteers and Patients with B-Cell Malignancies']",[],"['Acalabrutinib absorption', 'central and peripheral volumes of distribution', 'Acalabrutinib CL/F', 'clearance for ACP-5862']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}]",11196.0,0.0609812,"Relative to the 100 mg dose group, the 15 and 400 mg dose groups showed a 1.44-fold higher and 0.77-fold lower CL/F, respectively.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Edlund', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Boston, MA, USA. helena.edlund@astrazeneca.com.'}, {'ForeName': 'Sun Ku', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Quantitative Clinical Pharmacology, Acerta Pharma, South San Francisco, CA, USA.'}, {'ForeName': 'Marilee A', 'Initials': 'MA', 'LastName': 'Andrew', 'Affiliation': 'DMPK/Clinical Pharmacology, Acerta Pharma, Bellevue, WA, USA.'}, {'ForeName': 'J Greg', 'Initials': 'JG', 'LastName': 'Slatter', 'Affiliation': 'DMPK/Clinical Pharmacology, Acerta Pharma, Bellevue, WA, USA.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Aksenov', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Nidal', 'Initials': 'N', 'LastName': 'Al-Huniti', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Boston, MA, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-018-0725-7']
2532,31185379,Multiple biomarkers covering several pathways improve predictive ability for cognitive impairment among ischemic stroke patients with elevated blood pressure.,"BACKGROUND AND AIMS


We aimed to evaluate the ability of multiple novel biomarkers representing several pathophysiological pathways to improve risk prediction of post-stroke cognitive impairment.
METHODS


We conducted a prospective multicenter study in 638 ischemic stroke patients with elevated blood pressure based on a random subsample from China Antihypertensive Trial in Acute Ischemic Stroke and measured 12 circulating biomarkers in these participants. Cognitive impairment was assessed at 3 months after stroke with definitions of Mini-Mental State Examination (MMSE) score <27 or Montreal Cognitive Assessment (MoCA) score <25.
RESULTS


According to MMSE score, 1 SD increase of rheumatoid factor (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.02-1.46), matrix metalloproteinase-9 (OR 1.47, 95% CI 1.22-1.77) and total homocysteine (OR 1.22, 95% CI 1.01-1.49) after log transformation was significantly associated with the risk of post-stroke cognitive impairment. The ORs associated with their simultaneously high levels were 4.89 (95% CI, 2.31-10.35; p trend <0.001) and 3.09 (95% CI, 1.60-5.98; p trend <0.001) for cognitive impairment and the severity of cognitive impairment, respectively. Adding these 3 biomarkers to conventional model significantly improved the risk prediction of cognitive impairment (C statistic 0.729 vs. 0.688, p = 0.004; net reclassification improvement = 33.67%, p < 0.001; integrated discrimination index = 4.61%; p < 0.001). Similar significant findings were observed when cognitive impairment was defined by MoCA score.
CONCLUSIONS


Combination of rheumatoid factor, matrix metalloproteinase-9 and total homocysteine can improve the risk prediction of cognitive impairment among ischemic stroke patients with elevated blood pressure. Further studies are warranted to validate our findings and explore their roles as potential therapeutic targets.",2019,"Adding these 3 biomarkers to conventional model significantly improved the risk prediction of cognitive impairment (C statistic 0.729 vs. 0.688, p = 0.004; net reclassification improvement = 33.67%, p < 0.001; integrated discrimination index = 4.61%; p < 0.001).","['638 ischemic stroke patients with elevated blood pressure based on a random subsample from China Antihypertensive Trial in Acute Ischemic Stroke and measured 12 circulating biomarkers in these participants', 'ischemic stroke patients with elevated blood pressure']",[],"['rheumatoid factor (odds ratio [OR', 'risk prediction of cognitive impairment', 'cognitive impairment and the severity of cognitive impairment', 'Mini-Mental State Examination (MMSE) score <27 or Montreal Cognitive Assessment (MoCA) score', 'matrix metalloproteinase-9', 'total homocysteine ', 'cognitive impairment', 'Cognitive impairment']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",[],"[{'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]",,0.192521,"Adding these 3 biomarkers to conventional model significantly improved the risk prediction of cognitive impairment (C statistic 0.729 vs. 0.688, p = 0.004; net reclassification improvement = 33.67%, p < 0.001; integrated discrimination index = 4.61%; p < 0.001).","[{'ForeName': 'Zhengbao', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Chongke', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Daoxia', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Siping Central Hospital, Jilin, China.'}, {'ForeName': 'Jiale', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jilin Central Hospital, Jilin, China.'}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The 88th Hospital of PLA, Shandong, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Internal Medicine, Feicheng City People's Hospital, Shandong, China.""}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Tongliao Municipal Hospital, Inner Mongolia, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': ""Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia, China.""}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA, USA. Electronic address: jhe@tulane.edu.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China. Electronic address: yhzhang@suda.edu.cn.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.05.028']
2533,31411632,Optimal Combination of Compression Rate and Depth During Cardiopulmonary Resuscitation for Functionally Favorable Survival.,"Importance


Previous studies of basic cardiopulmonary resuscitation (CPR) indicate that both chest compression rate (CCR) and chest compression depth (CCD) each are associated with survival probability after out-of-hospital cardiac arrest. However, an optimal CCR-CCD combination has yet to be identified, particularly with respect to age, sex, presenting cardiac rhythm, and CPR adjunct use.
Objectives


To identify an ideal CCR-CCD combination associated with the highest probability of functionally favorable survival and to assess whether this combination varies with respect to age, sex, presenting cardiac rhythm, or CPR adjunct use.
Design, Setting, and Participants


This cohort study used data collected between June 2007 and November 2009 from a National Institutes of Health (NIH) clinical trials network registry of out-of-hospital and in-hospital emergency care provided by 9-1-1 system agencies participating in the network across the United States and Canada (n = 150). The study sample included 3643 patients who had out-of-hospital cardiac arrest and for whom CCR and CCD had been simultaneously recorded during an NIH clinical trial of a CPR adjunct. Subgroup analyses included evaluations according to age, sex, presenting cardiac rhythm, and application of a CPR adjunct. Data analysis was performed from September to November 2018.
Interventions


Standard out-of-hospital cardiac arrest interventions compliant with the concurrent American Heart Association guidelines as well as use of the CPR adjunct device in half of the patients.
Main Outcomes and Measures


The optimal combination of CCR-CCD associated with functionally favorable survival (modified Rankin scale ≤3) overall and by age, sex, presenting cardiac rhythm, and CPR adjunct use.
Results


Of 3643 patients, 2346 (64.4%) were men; the mean (SD) age was 67.5 (15.7) years. The identified optimal CCR-CCD for all patients was 107 compressions per minute and a depth of 4.7 cm. When CPR was performed within 20% of this value, survival probability was significantly higher (6.0% vs 4.3% outside that range; odds ratio, 1.44; 95% CI, 1.07-1.94; P = .02). The optimal CCR-CCD combination remained similar regardless of age, sex, presenting cardiac rhythm, or CPR adjunct use. The identified optimal CCR-CCD was associated with significantly higher probabilities of survival when the CPR device was used compared with standard CPR (odds ratio, 1.90; 95% CI, 1.06-3.38; P = .03), and the device's effectiveness was dependent on being near the target CCR-CCD combination.
Conclusions and Relevance


The findings suggest that the combination of 107 compressions per minute and a depth of 4.7 cm is associated with significantly improved outcomes for out-of-hospital cardiac arrest. The results merit further investigation and prospective validation.",2019,"The identified optimal CCR-CCD was associated with significantly higher probabilities of survival when the CPR device was used compared with standard CPR (odds ratio, 1.90; 95% CI, 1.06-3.38; P = .03), and the device's effectiveness was dependent on being near the target CCR-CCD combination.
","['Participants\n\n\nThis cohort study used data collected between June 2007 and November 2009 from a National Institutes of Health (NIH) clinical trials network registry of out-of-hospital and in-hospital emergency care provided by 9-1-1 system agencies participating in the network across the United States and Canada (n\u2009=\u2009150', '3643 patients, 2346 (64.4%) were men; the mean (SD) age was 67.5 (15.7) years', '3643 patients who had out-of-hospital cardiac arrest and for whom CCR and CCD had been simultaneously recorded during an NIH clinical trial of a CPR adjunct']","['Interventions\n\n\nStandard out-of-hospital cardiac arrest interventions compliant with the concurrent American Heart Association guidelines', 'Compression Rate and Depth During Cardiopulmonary Resuscitation', 'basic cardiopulmonary resuscitation (CPR']","['survival probability', 'probabilities of survival', 'chest compression rate (CCR) and chest compression depth (CCD', ""device's effectiveness""]","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",3643.0,0.0435835,"The identified optimal CCR-CCD was associated with significantly higher probabilities of survival when the CPR device was used compared with standard CPR (odds ratio, 1.90; 95% CI, 1.06-3.38; P = .03), and the device's effectiveness was dependent on being near the target CCR-CCD combination.
","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Duval', 'Affiliation': 'Cardiovascular Division, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Pepe', 'Affiliation': 'Department of Medicine, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Goodloe', 'Affiliation': 'Department of Emergency Medicine, University of Oklahoma School of Community Medicine, Tulsa.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debaty', 'Affiliation': 'Department of Emergency Medicine, University Hospital of Grenoble Alps, Grenoble, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Labarère', 'Affiliation': 'Department of Emergency Medicine, University Hospital of Grenoble Alps, Grenoble, France.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Cardiovascular Division, University of Minnesota Medical School, Minneapolis.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2717']
2534,31464859,Determinants of Acquisition and Clearance of Human Papillomavirus Infection in Previously Unexposed Young Women.,"BACKGROUND


Global variation in human papillomavirus (HPV) prevalence and persistence may be explained by differences in risk factors, such as sexual activity, oral contraceptive use, and behavioral factors. We evaluated determinants of acquisition and clearance of HPV infection among young women previously unexposed to HPV.
METHODS


Five hundred thirty-four women aged 15 to 25 years who were cytology and HPV DNA negative, and seronegative for anti-HPV-16/18 antibodies, were recruited (July 2000-September 2001) from study centers in Brazil, the United States, and Canada (NCT00689741/NCT00120848). They were followed up for 76 months. Cervical samples were HPV genotyped via polymerase chain reaction. We used multivariable (forward stepwise, P = 0.15) Cox proportional hazards regression to estimate rate ratios (RR) and 95% confidence intervals (CI), separately according to length of follow-up time.
RESULTS


On short-term follow-up (0-27 months), 257 (48%; 8535.80 person-months; incidence rate = 30.11; 95% CI, 26.64-34.02) incident HPV infections were detected. Marital status, lifetime number of sex partners, history of any sexually transmitted disease, and occasional use of oral contraceptives were strongly associated with acquisition of any HPV. Having 2 or more lifetime sex partners (RR, 2.03; 95% CI, 1.37-3.02) and a history of any sexually transmitted disease (RR, 1.98; 95% CI, 1.19-3.29) were the most important determinants of high-risk HPV (hrHPV) incidence. During the entire follow-up (0-76 months), an increased hrHPV clearance was found among women in North America (RR, 1.38; 95% CI, 1.08-1.78) and black women (RR, 1.64; 95% CI, 1.04-2.60). Greater number of lifetime partners was associated with reduced clearance rates for any HPV (RR, 0.65; 95% CI, 0.43-0.98).
CONCLUSIONS


We identified variation in risk of HPV acquisition and clearance among women unexposed to HPV at baseline.",2019,"During the entire follow-up (0-76 months), an increased hrHPV clearance was found among women in North America (RR, 1.38; 95% CI, 1.08-1.78) and black women (RR, 1.64; 95% CI, 1.04-2.60).","['human papillomavirus (HPV', 'Five hundred thirty-four women aged 15 to 25 years who were cytology and HPV DNA negative, and seronegative for anti-HPV-16/18 antibodies, were recruited (July 2000-September 2001) from study centers in Brazil, the United States, and Canada (NCT00689741/NCT00120848', 'young women previously unexposed to HPV', 'Previously Unexposed Young Women']",[],"['acquisition and clearance of HPV infection', 'incident HPV infections', 'Greater number of lifetime partners', 'clearance rates', 'hrHPV clearance', 'risk of HPV acquisition and clearance', 'history of any sexually transmitted disease', 'Marital status, lifetime number of sex partners, history of any sexually transmitted disease, and occasional use of oral contraceptives']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C3872595', 'cui_str': 'Human papillomavirus DNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]",534.0,0.181177,"During the entire follow-up (0-76 months), an increased hrHPV clearance was found among women in North America (RR, 1.38; 95% CI, 1.08-1.78) and black women (RR, 1.64; 95% CI, 1.04-2.60).","[{'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'From the Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Agnihotram V', 'Initials': 'AV', 'LastName': 'Ramanakumar', 'Affiliation': 'From the Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Naud', 'Affiliation': 'Federal University of Rio Grande do Sul-UFRGS/HCPA, Hospital de Clínicas de Porto Alegre, Porto Alegre.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Roteli-Martins', 'Affiliation': 'Leonor Mendes de Barros Hospital-Secretaria da Saude de São Paulo, São Paulo.'}, {'ForeName': 'Newton S', 'Initials': 'NS', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Gynecology and Obstetrics, Gynecology and Obstetrics Infectious Diseases Sector, Federal University of Parana, Curitiba, Parana.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Colares de Borba', 'Affiliation': 'Instituto de Prevenção do Câncer, Fortaleza.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Teixeira', 'Affiliation': 'Department of Gynecology and Obstetrics, Oncology Division-CAISM, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Moscicki', 'Affiliation': 'University of California, Division of Adolescent Medicine, San Francisco, CA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Harper', 'Affiliation': 'Department of Obstetrics and Gynecology and Community and Family Medicine, Geisel Medical School at Dartmouth, Norris Cotton Cancer Center, Hanover, NH.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Departments of Microbiology/Molecular Genetics, Dermatology & Internal.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ramjattan', 'Affiliation': ""First Line Medical Services Ltd., St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'Takeda Pharmaceuticals, Zurich, Switzerland.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'From the Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001053']
2535,31517806,Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method.,"BACKGROUND


The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory.
METHODS


The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen's κ, percent concordance, McNemar equivalence, and others were tested statistically.
RESULTS


One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests.
CONCLUSIONS


The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection.",2019,"The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests.
","['Patients were recruited from 2 cancer screening clinics 2015 to 2017', 'One hundred seventy-four patients were randomized']",[],"[""similarity between self and standard collection outcomes, Cohen's κ, percent concordance, McNemar equivalence"", 'standard, sensitivity, and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517867', 'cui_str': '74'}]",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",174.0,0.0310371,"The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests.
","[{'ForeName': 'Jerry W', 'Initials': 'JW', 'LastName': 'McLarty', 'Affiliation': 'From the Feist-Weiller Cancer Center, School of Medicine, Louisiana State University Health Sciences Center, Shreveport.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Williams', 'Affiliation': 'School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Loyd', 'Affiliation': 'From the Feist-Weiller Cancer Center, School of Medicine, Louisiana State University Health Sciences Center, Shreveport.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Hagensee', 'Affiliation': 'School of Public Health, Louisiana State University Health Sciences Center, New Orleans, LA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001045']
2536,32649736,Antiviral Activity and Pharmacokinetics of the HBV Capsid Assembly Modulator GLS4 in Patients with Chronic HBV Infection.,"BACKGROUND


GLS4 is a first-in-class hepatitis B virus (HBV) capsid assembly modulator (class I) that can inhibit HBV replication by interfering with the assembly and disassembly of HBV nucleocapsid. Here, we evaluated its antiviral activity, pharmacokinetics (PK), and tolerability in a double-blind, randomized, parallel, entecavir-controlled study.
METHODS


Twenty four chronic HBV patients were randomized to receive a 28-day course of GLS4 (120 or 240 mg) and ritonavir (100 mg) combination (cohorts A and B, respectively) or entecavir treatment (cohort C) at a 1:1:1 ratio. Patients were followed-up for 40 days in a phase 1b study.
RESULTS


The GLS4/ritonavir combination was a tolerated combination for the treatment of chronic HBV infection. A total of two, three, and three subjects presented with alanine aminotransferase flare in cohorts A, B and C, respectively. This contributed to the withdrawal of one, two, and one patient from cohorts A, B and C, respectively. The mean Ctrough of GLS4 was 205-218 ng/mL, which was approximately 3.7-3.9 times the EC90 (55.8 ng/mL), with a lower accumulation (accumulation rate: 1.1-2.0). In cohorts A, B and C, the mean declines in HBV DNA after 28 days of treatment were -1.42, -2.13, and -3.5 log10 IU/mL; in hepatitis B surface antigen were -0.06, -0.14, and -0.33 log10 IU/mL; in pregenomic RNA were -0.75, -1.78, and -0.96 log10 copies/mL; and in hepatitis B core antigen (were -0.23, -0.5, and -0.44 log10 U/mL, respectively.
CONCLUSIONS


Treatment with 120 mg GLS4 was tolerated and had antiviral activity in patients with chronic HBV infection.",2020,"In cohorts A, B and C, the mean declines in HBV DNA after 28 days of treatment were -1.42, -2.13, and -3.5 log10 IU/mL; in hepatitis B surface antigen were -0.06, -0.14, and -0.33 log10 IU/mL; in pregenomic RNA were -0.75, -1.78, and -0.96 log10 copies/mL; and in hepatitis B core antigen (were -0.23, -0.5, and -0.44 log10 U/mL, respectively.
","['Patients with Chronic HBV Infection', 'Twenty four chronic HBV patients', 'patients with chronic HBV infection']","['entecavir treatment', 'GLS4/ritonavir combination', 'GLS4', 'HBV Capsid Assembly Modulator GLS4', 'ritonavir']","['alanine aminotransferase flare', 'tolerated and had antiviral activity', 'hepatitis B surface antigen', 'mean Ctrough of GLS4', 'HBV DNA', 'antiviral activity, pharmacokinetics (PK), and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0006933', 'cui_str': 'Capsid'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",24.0,0.0451186,"In cohorts A, B and C, the mean declines in HBV DNA after 28 days of treatment were -1.42, -2.13, and -3.5 log10 IU/mL; in hepatitis B surface antigen were -0.06, -0.14, and -0.33 log10 IU/mL; in pregenomic RNA were -0.75, -1.78, and -0.96 log10 copies/mL; and in hepatitis B core antigen (were -0.23, -0.5, and -0.44 log10 U/mL, respectively.
","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yunfu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'HEC R&D Center, Sunshine Lake Pharma Co., Ltd.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'HEC R&D Center, Sunshine Lake Pharma Co., Ltd.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Jilin, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa961']
2537,32649760,"Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial.","BACKGROUND


Maternal supplementation during lactation could increase milk B-vitamin concentrations, but little is known about the kinetics of milk vitamin responses.
OBJECTIVES


We compared acute effects of maternal lipid-based nutrient supplement (LNS) consumption (n = 22 nutrients, 175%-212% of the RDA intake for the nutrients examined), as a single dose or at spaced intervals during 8 h, on milk concentrations and infant intake from milk of B-vitamins.
METHODS


This randomized crossover trial in Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum who were randomly assigned to receive 3 treatments in a random order: bolus 30-g dose of LNS (Bolus); 3 × 10-g doses of LNS (Divided); and no LNS (Control), with control meals. Mothers attended three 8-h visits during which infant milk consumption was measured and milk samples were collected at every feed. Infant intake was assessed as $\mathop \sum \nolimits_{i\ = \ 1}^n ( {{\rm{milk\ volum}}{{\rm{e}}_{{\rm{feed\ }}n}} \times \ {\rm{nutrient\ concentratio}}{{\rm{n}}_{{\rm{feed}}\ n}}} )\ $over 8 h.
RESULTS


Maternal supplementation with the Bolus or Divided dose increased least-squares mean (95% CI) milk and infant intakes of riboflavin [milk: Bolus: 154.4 (138.2, 172.5) μg · min-1 · mL-1; Control: 84.5 (75.8, 94.3) μg · min-1 · mL-1; infant: Bolus: 64.5 (56.1, 74.3) μg; Control: 34.5 (30.0, 39.6) μg], thiamin [milk: Bolus: 10.9 (10.1, 11.7) μg · min-1 · mL-1; Control: 7.7 (7.2, 8.3) μg · min-1 · mL-1; infant: Bolus: 5.1 (4.4, 6.0) μg; Control: 3.4 (2.9, 4.0) μg], and pyridoxal [milk: Bolus: 90.5 (82.8, 98.9) μg · min-1 · mL-1; Control: 60.8 (55.8, 66.3) μg · min-1 · mL-1; infant: Bolus: 39.4 (33.5, 46.4) μg; Control: 25.0 (21.4, 29.2) μg] (all P < 0.001). Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018) μg, P = 0.001] compared with Control. Niacin was unaffected.
CONCLUSIONS


Maternal supplementation with LNS as a Bolus or Divided dose was similarly effective at increasing milk riboflavin, thiamin, and pyridoxal and infant intakes, whereas only the Bolus dose increased cobalamin. Niacin was unaffected in 8 h. This trial was registered at clinicaltrials.gov as NCT02464111.",2020,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","['lactating Guatemalan women acutely increases infants', 'Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum']","['Niacin', 'LNS (Divided); and no LNS (Control), with control meals', 'maternal lipid-based nutrient supplement (LNS) consumption', 'LNS (Bolus); 3\xa0×', 'Micronutrient supplementation']","[' intake of riboflavin, thiamin, pyridoxal, and cobalamin', 'Infant intake', 'milk B-vitamin concentrations', ' 1}^n ( {{\\rm{milk\\ volum}}{{\\rm{e}}_{{\\rm{feed\\ }}n}} \\times \\ {\\rm{nutrient\\ concentratio}}{{\\rm{n}}_{{\\rm{feed}}\\ n}}} ', 'milk riboflavin, thiamin, and pyridoxal and infant intakes', 'least-squares mean']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0034263', 'cui_str': 'Pyridoxal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.372535,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","[{'ForeName': 'Juliana A', 'Initials': 'JA', 'LastName': 'Donohue', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Solomons', 'Affiliation': 'Center for Studies of Sensory Impairment, Aging and Metabolism, Guatemala City, Guatemala.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Mónica N', 'Initials': 'MN', 'LastName': 'Orozco', 'Affiliation': 'Center for Atitlán Studies, Universidad del Valle de Guatemala, Sololá, Guatemala.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa147']
2538,32649808,In vivo evaluation of the impact of various border molding materials and techniques on the retention of complete maxillary dentures.,"BACKGROUND


Different techniques and impression materials are employed in the process of fabricating complete denture (CD) bases.
OBJECTIVES


The aim of this study was to determine differences in the denture base retention for acrylic maxillary CDs when using 2 different techniques and impression materials. Specifically, the green stick compound impression material was used for the sectional border molding technique and this was compared to using the addition vinyl silicone impression material with the single-step technique.
MATERIAL AND METHODS


A crossover study was conducted on 10 participants who were completely edentulous in the upper arch (6 men and 4 women), aged 43-70 years. The participants' trays were split into 2 treatment groups: the P-group; and the Z-group. Addition vinyl silicone was used for single-step border molding in the P-group, followed by light-body final-wash impression. For the Z-group, the green stick compound was used for sectional border molding, followed by a final wash using a zinc oxideeugenol material.To quantify the retention force of the denture base in kilograms-force, a digital force gauge was used.
RESULTS


The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
CONCLUSIONS


The results suggest the superiority of using the single-step border molding technique in the upper arch with the addition vinyl silicone material owing to the enhanced base retention of the acrylic denture base.",2020,"The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
","['10 participants who were completely edentulous in the upper arch (6 men and 4 women), aged 43-70 years']",['Addition vinyl silicone'],"['retention of complete maxillary dentures', 'mean retention values']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011458', 'cui_str': 'Complete upper denture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.0362127,"The measurements indicated significantly higher mean retention values (p = 0.000) in the P‑group (4.02 ±1.66 kgf) as compared to the Z‑group (1.48 ±0.90 kgf).
","[{'ForeName': 'Tameem Khuder', 'Initials': 'TK', 'LastName': 'Jassim', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}, {'ForeName': 'Ali Ehsan', 'Initials': 'AE', 'LastName': 'Kareem', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}, {'ForeName': 'Mohamed Adnan', 'Initials': 'MA', 'LastName': 'Alloaibi', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq.'}]",Dental and medical problems,['10.17219/dmp/115104']
2539,32649851,Jin Shin Jyutsu® Self-Help Reduces Nurse Stress: A Randomized Controlled Study.,"Purpose:  The purpose of this research was to explore the impact of Jin Shin Jyutsu (JSJ) Self-Help on personal stress and the caring efficacy of nurses.  Design:  A randomized, controlled comparison study, with crossover design was conducted.  Method:  Stress and caring efficacy were measured via surveys at baseline, posteducation, and again 30 to 40 days after completion of the JSJ educational intervention. Self-reported stress was the primary endpoint as measured with the validated Personal and Organizational Quality Assessment-Revised 4 Scale (POQA-R4) survey. Caring Efficacy was measured using the Coates Caring Efficacy Scale.  Findings:  A total of 41 nurses consented and completed the study; 18 were in the education group and 23 were in the control group. Changes in stress were sustained in the education group for the POQA-R4. Changes observed in the control group were not sustained. Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy. Increases in nursing caring efficacy were observed in both groups. Scores were consistently higher in the education group. Statistically significant differences were observed from baseline to final measure for the education group.  Conclusions:  Results show JSJ as a viable option for stress reduction in nurses.",2020,Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy.,['41 nurses consented and completed the study; 18 were in the education group and 23 were in the control group'],"['Jin Shin Jyutsu (JSJ', 'JSJ', 'JSJ educational intervention', 'Jin Shin Jyutsu®']","['Self-Help Reduces Nurse Stress', 'validated Personal and Organizational Quality Assessment-Revised 4 Scale (POQA-R4) survey', 'Coates Caring Efficacy Scale', 'Caring Efficacy', 'nursing caring efficacy']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0230444', 'cui_str': 'Shin structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",41.0,0.0257006,Statistical differences were observed when comparing education and control from baseline to final surveys for measures of emotional vitality and buoyancy.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Millspaugh', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Errico', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Sunnie', 'Initials': 'S', 'LastName': 'Mortimer', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Mildred Ortu', 'Initials': 'MO', 'LastName': 'Kowalski', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Reifsnyder', 'Affiliation': 'Atlantic Health System/Morristown Medical Center.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010120938922']
2540,32650050,Outcomes of Arthroscopic Rotator Cuff Repair in Stiff Shoulders are Comparable to Non-stiff Shoulders when Combined with Manipulation Under Anesthesia.,"PURPOSE


The purpose of this study was to compare the outcomes of arthroscopic rotator cuff repair (ARCR) in patients with preoperative stiffness to those without.
METHODS


A total of 135 patients were prospectively evaluated for 2 years after ARCR for small to medium sized rotator cuff tears at our institution. Patients were divided into stiff (<100 degrees of passive forward flexion) and non-stiff cohorts. The stiff group underwent manipulation under anesthesia (MUA) prior to ARCR being performed. Outcomes were measured using Visual Analog Scale (VAS), Constant Shoulder Score (CSS), and Oxford Shoulder Score (OSS) recorded at the preoperative, 6- , 12-, and 24-month time points. The results of ARCR between the cohorts were then compared.
RESULTS


A total of 123 out of 135 patients (91.1%) completed the follow-up (stiff n=46, non-stiff n=77). There were significant improvements in the mean CSS scores at 6- (mean 59.87, p<0.001) and 12-months (mean 65.88, p=0.021) in the stiff group. There were no significant differences detectable in the CSS and OSS scores between the stiff and non-stiff groups at 6-, 12- and 24-months. However, the percentage of patients achieving MCID was significantly higher in the stiff group (97.8%) compared with the non-stiff group (75.3%; p=0.001). The VAS scores, forward flexion and strength in both groups were found to be comparable.
CONCLUSIONS


The results of our study showed no significant differences in outcomes scores in patients with stiff shoulders who underwent MUA combined with ARCR compared to patients with non-stiff shoulders who underwent ARCR alone. Therefore, early surgical repair should be considered in patients with rotator cuff tears and concomitant shoulder stiffness.",2020,"There were significant improvements in the mean CSS scores at 6- (mean 59.87, p<0.001) and","['patients with rotator cuff tears and concomitant shoulder stiffness', 'patients with preoperative stiffness to those without', 'A total of 135 patients were prospectively evaluated for 2 years after ARCR for small to medium sized rotator cuff tears at our institution', 'A total of 123 out of 135 patients (91.1%) completed the follow-up (stiff n=46, non-stiff n=77', 'patients with stiff shoulders']","['manipulation under anesthesia (MUA', 'arthroscopic rotator cuff repair (ARCR', 'Arthroscopic Rotator Cuff Repair', 'MUA combined with ARCR']","['VAS scores, forward flexion and strength', 'CSS and OSS scores', 'mean CSS scores', 'percentage of patients achieving MCID', 'Visual Analog Scale (VAS), Constant Shoulder Score (CSS), and Oxford Shoulder Score (OSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0498269', 'cui_str': 'Manipulation under anesthesia'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",135.0,0.0192911,"There were significant improvements in the mean CSS scores at 6- (mean 59.87, p<0.001) and","[{'ForeName': 'Junren', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Associate Consultant Department of Orthopaedic Surgery, Tan Tock Seng Hospital 1 Jalan Tan Tock Seng 308433. Electronic address: junren_ZHANG@ttsh.com.sg.'}, {'ForeName': 'Tan Yeow', 'Initials': 'TY', 'LastName': 'Boon', 'Affiliation': 'Medical Officer, Department of Orthopaedic Surgery, Singapore General Hospital.'}, {'ForeName': 'Denny Lie', 'Initials': 'DL', 'LastName': 'Tjiauw Tjoen', 'Affiliation': 'Senior Consultant Department of Orthopaedic Surgery, Singapore General Hospital.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.06.025']
2541,32650074,A Break-Even Analysis of Benzoyl Peroxide and Hydrogen Peroxide for Infection Prevention in Shoulder Arthroplasty.,"BACKGROUND


Newer strategies to decolonize the shoulder of Cutibacterium acnes may hold promise in minimizing the occurrence of infections after shoulder arthroplasty, but little is known about their cost-effectiveness. Break-even models can determine the economic viability of interventions in settings with low outcome event rates that would realistically preclude a randomized clinical trial. We used such modeling to determine the economic viability of benzoyl peroxide and hydrogen peroxide for infection prevention in shoulder arthroplasty.
METHODS


Skin decolonization protocol costs ($11.76 for benzoyl peroxide; $0.96 for hydrogen peroxide), baseline infection rates for shoulder arthroplasty (0.70%), and infection-related care costs ($50,230) were derived from institutional records and the literature. A break-even equation incorporating these variables was developed to determine the absolute risk reduction (ARR) in infection rate to make prophylactic use economically justified. The number needed to treat was calculated from the ARR.
RESULTS


Topical benzoyl peroxide is considered economically justified if it prevents at least 1 infection out of 4,348 shoulder arthroplasties (ARR=0.023%). Hydrogen peroxide is economically justified if it prevents at least 1 infection out of 50,000 cases (ARR=0.002%). These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
CONCLUSIONS


The use of topical benzoyl peroxide and skin preparations with hydrogen peroxide are highly economically justified practices for infection prevention in shoulder arthroplasty. Efforts to determine drawbacks of routine skin decolonization strategies are warranted as they may change the value analysis.",2020,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","['shoulder arthroplasty', 'shoulder arthroplasty (0.70%), and infection-related care costs ($50,230', 'Shoulder Arthroplasty']","['benzoyl peroxide and hydrogen peroxide', 'Hydrogen peroxide', 'topical benzoyl peroxide and skin preparations with hydrogen peroxide', 'benzoyl peroxide; $0.96 for hydrogen peroxide', 'Benzoyl Peroxide and Hydrogen Peroxide']","['initial infection rates, and infection-related care costs']","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",50230.0,0.0321727,"These protocols remained economically viable at varying unit costs, initial infection rates, and infection-related care costs.
","[{'ForeName': 'Mariano E', 'Initials': 'ME', 'LastName': 'Menendez', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA. Electronic address: marianofurrer@gmail.com.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Moverman', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Puzzitiello', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Pagani', 'Affiliation': 'Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA; Department of Orthopaedic Surgery, Newton-Wellesley Hospital, Newton, MA, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Rothman Institute, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.019']
2542,32650077,Delto-Pectoral vs Deltoid split approach for proximal HUmerus fracture fixation with locking plate.,"BACKGROUND


This study aimed to compare the functional and clinical outcomes between the deltoid split (DS) approach and the classic deltopectoral (DP) approach for locking plate fixation of proximal humerus fractures (PHF) in a prospective randomized multicenter study.
METHODS


From 2007 to 2015, all patients with a PHF Neer II/III, were invited to participate. Exclusion criteria were: pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment. After consent, patients were randomized to one of the two treatments using the dark envelope method. Functional outcome was evaluated by validated questionnaires (SF-12v2, Q-DASH,) with a minimum follow-up of 12 months. Complications were noted.
RESULTS


85 patients (44 DS, 41 DP) were randomized (mean age of 62). Groups were equivalent in terms of age, gender, BMI, severity of fracture and pre-injury scores. Mean follow-up was 26 months. All clinical outcome measures were in favor of the deltopectoral approach. Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively). There were more complications in DS patients but it did not reach statistical significance.
CONCLUSIONS


The primary hypothesis on the superiority of the deltoid split incision was rebutted. Based on our study, the DP approach seems to offer better function compared to the DS approach for fixation of Neer 2 and 3 PHF fractures fixed with a locking plate.",2020,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","['85 patients (44 DS, 41 DP', 'From 2007 to 2015, all patients with a PHF Neer II/III, were invited to participate', 'proximal humerus fractures (PHF', 'Exclusion criteria were: pre-existing pathology to the limb, patient refusing or too ill to undergo surgery, patient needing another type of treatment (nail, arthroplasty), and axillary nerve impairment']","['Delto-Pectoral vs Deltoid split approach', 'deltoid split (DS) approach and the classic deltopectoral (DP) approach']",['Complications'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0450110', 'cui_str': 'Deltopectoral approach'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0329204,"Specifically, the Q-DASH, was better in the DP group (12 vs 26, p=0,003) and SF-12v2: 56 vs 51, p=0,049, respectively).","[{'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Rouleau', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, QC, Canada, H4J 1C5; Faculty of Medicine, Université de Montréal, 2900 Boulevard Edouard-Montpetit, Montréal, QC. Canada, H3T 1J4. Electronic address: dominique.rouleau@umontreal.ca.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Balg', 'Affiliation': 'Centre universitaire de santé de Sherbrooke, 375 rue Argyll, Sherbrooke, QC. Canada, J1J 3H5.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, QC, Canada, H4J 1C5; Faculty of Medicine, Université de Montréal, 2900 Boulevard Edouard-Montpetit, Montréal, QC. Canada, H3T 1J4.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, QC, Canada, H4J 1C5; Faculty of Medicine, Université de Montréal, 2900 Boulevard Edouard-Montpetit, Montréal, QC. Canada, H3T 1J4.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malo', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, QC, Canada, H4J 1C5; Faculty of Medicine, Université de Montréal, 2900 Boulevard Edouard-Montpetit, Montréal, QC. Canada, H3T 1J4.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vézina', 'Affiliation': 'Centre universitaire de santé de Sherbrooke, 375 rue Argyll, Sherbrooke, QC. Canada, J1J 3H5.'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'CIUSS, Hopital Sacré Coeur de Montréal, QC, Canada, H4J 1C5; Faculty of Medicine, Université de Montréal, 2900 Boulevard Edouard-Montpetit, Montréal, QC. Canada, H3T 1J4.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.06.020']
2543,32650155,Comparative effects of water- and land-based combined exercise training in hypertensive older adults.,"OBJECTIVES


A randomized controlled trial was designed to compare water- and land-based combined (aerobic and resistance) exercise training programs on cardiometabolic parameters, functional fitness, and quality-of-life (QoL) in hypertensive older adults.
METHODS


Fifty-three participants were divided into three groups: 1) land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON, n=20). All programs comprised of a 12-week supervised training program (three 1-hr sessions per week), followed by a 12-week self-supervised training program. Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL were assessed before and after each period.
RESULTS


Following the supervised period, systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL significantly improved in both training groups. Only the WET improved LDL-C and lipoprotein combine index. Meanwhile, the 30s chair-stand test and 2-min step test improved only in the LET. Succeeding the self-supervised period, systolic BP and NOx- concentration significantly improved in both training groups. Notwithstanding, the 30s chair-standing and arm curl tests improved only in the LET.
CONCLUSIONS


Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET. Nevertheless, metabolic variables were greater improved in the WET. Additionally, due to greater exercise participation, the WET program may be a useful tool in motivating hypertensive older adults to continuously exercise on their own.",2020,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","['hypertensive older adults', 'motivating hypertensive older adults', 'Fifty-three participants were divided into three groups: 1']","['water- and land-based combined (aerobic and resistance) exercise training programs', 'land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON', 'supervised training program', 'water- and land-based combined exercise training']","['metabolic variables', 'ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL', 'cardiometabolic parameters, functional fitness, and quality-of-life (QoL', 'systolic BP and NOx- concentration', 'Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL', 'LDL-C and lipoprotein combine index', 'systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.0142118,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","[{'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Ruangthai', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand. Electronic address: jatuporn.w@ku.th.'}, {'ForeName': 'Niromlee', 'Initials': 'N', 'LastName': 'Makaje', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Phornphon', 'Initials': 'P', 'LastName': 'Phimphaphorn', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104164']
2544,32650346,Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration in solid pancreatic lesions: a single-center prospective randomized trial.,"BACKGROUND


Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) can visualize necrotic areas and vessels inside lesions. CH-EUS findings combined with EUS-guided fine-needle aspiration (EUS-FNA) improves diagnosis in pancreatic solid masses. CH-EUS can also guide EUS-FNA (CH-EUS-FNA), potentially improving the diagnostic rate of EUS-FNA, but such superiority has not been proved in prospective studies. We aimed to assess whether CH-EUS-FNA is superior to standard EUS-FNA for specific diagnosis of solid pancreatic masses and what factors affect the diagnostic rate.
METHODS


This randomized controlled study in one tertiary medical academic center included patients with suspected pancreatic solid masses on transabdominal ultrasound or computed tomography (CT) scan. Two passes with a 22-G standard FNA needle were done using EUS-FNA and CH-EUS-FNA in random order, and the visible core obtained was sent for histological analysis. Final diagnosis was based on EUS-FNA or surgical specimen results and on 12-month follow-up by imaging.
RESULTS


148 patients were evaluated. EUS-FNA and CH-EUS-FNA showed diagnostic sensitivities of 85.5 % and 87.6 %, respectively (not significantly different) and the combined sensitivity of the two passes was 93.8 %. The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results. No differences were seen for the results related to location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent.
CONCLUSIONS


The diagnostic rates for samples obtained using 22-G needles with standard EUS-FNA and CH-EUS-FNA were not statistically significantly different.",2020,The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results.,"['148 patients were evaluated', 'one tertiary medical academic center included patients with suspected pancreatic solid masses on', 'solid pancreatic lesions']","['EUS-FNA and CH-EUS', 'EUS-guided fine-needle aspiration (EUS-FNA', 'Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS', 'CH-EUS', 'CH-EUS-FNA', 'transabdominal ultrasound or computed tomography (CT) scan', 'Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration']","['diagnostic sensitivities', 'location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent', 'diagnostic rates', 'false-negative rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",148.0,0.0229746,The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results.,"[{'ForeName': 'Andrada', 'Initials': 'A', 'LastName': 'Seicean', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Andrada', 'Initials': 'A', 'LastName': 'Samarghitan', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Sorana D', 'Initials': 'SD', 'LastName': 'Bolboacă', 'Affiliation': 'Department of Medical Informatics and Biostatistics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pojoga', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Rusu', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gheorghiu', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Al Hajjar', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Seicean', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",Endoscopy,['10.1055/a-1193-4954']
2545,32650347,Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose.,"BACKGROUND


This study evaluated the impact of power setting and proton pump inhibitor (PPI) dose on efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). METHODS : 71 patients were randomized to APC with power set at 90 W or 60 W followed by 120 mg or 40 mg omeprazole. The primary outcome was the rate of complete (endoscopic and histologic) ablation of BE at 6 weeks. Secondary outcomes included safety and long-term efficacy. RESULTS : Complete ablation rate in the 90 W/120 mg, 90 W/40 mg, and 60 W/120 mg groups was 78 % (18/23; 95 % confidence interval [CI] 61-95), 60 % (15/25; 95 %CI 41-79), 74 % (17/23; 95 %CI 56-92), respectively, at 6 weeks and 70 % (16/23; 95 %CI 51-88), 52 % (13/25; 95 %CI 32-72), and 65 % (15/23; 95 %CI 46-85) at 2 years post-treatment (differences not significant). Additional APC was required in 28 patients (23 residual and 5 recurrent BE). At median follow-up of 108 months, 66/71 patients (93 %; 95 %CI 87-99) maintained complete ablation. No high-grade dysplasia or adenocarcinoma developed. Overall, adverse events (97 % mild) did not differ significantly between groups. Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001). One patient had esophageal perforation and two developed stenosis.
CONCLUSIONS


APC power setting and PPI dose did not impact efficacy and safety of BE ablation. Complete ablation of BE with LGD was durable in > 90 % of patients, without any evidence of neoplasia progression in the long term.",2020,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[""Barrett's esophagus with low-grade dysplasia"", ""Barrett's esophagus (BE) with low-grade dysplasia (LGD"", '28 patients (23 residual and 5 recurrent BE', '71 patients']","['omeprazole', 'Argon plasma coagulation', 'power setting and proton pump inhibitor (PPI', 'argon plasma coagulation (APC']","['Overall, adverse events', 'neoplasia progression', 'esophageal perforation', 'Chest pain/discomfort', 'rate of complete (endoscopic and histologic) ablation of BE', 'stenosis', 'Complete ablation rate', 'safety and long-term efficacy']","[{'cui': 'C1334414', 'cui_str': 'Barretts esophagus with low grade dysplasia'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0014860', 'cui_str': 'Perforation of esophagus'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",71.0,0.245348,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wronska', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Polkowski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Orlowska', 'Affiliation': 'Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mroz', 'Affiliation': 'Department of Pathomorphology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}]",Endoscopy,['10.1055/a-1203-5930']
2546,32650511,"Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","OBJECTIVE


the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ) on the symptoms and functionality of knee osteoarthritis (OA).
METHODS


60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs - NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured.
RESULTS


In FS-HA ®  treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values ( p  < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05). The FS-HA ®  treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones ( p  < 0.05).
CONCLUSION


the oral supplementation with a FS-HA ®  characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.",2020,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","['60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA', 'Knee Osteoarthritis']","['oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA ® ', 'New Oral Sodium Hyaluronate Formulation', 'Placebo', 'placebo']","['Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p', 'VAS-p, pain and total WOMAC score, LFI and ROM', 'range of knee joint motion (ROM', 'pain WOMAC score']","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",60.0,0.177501,"At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA ®  treatment when compared with placebo as well ( p  < 0.05).","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Girolimetto', 'Affiliation': 'Department of Rheumatology, Azienda USL-IRCCS di Reggio Emilia, 42121 Reggio Emilia, Italy.'}, {'ForeName': 'Crescenzio', 'Initials': 'C', 'LastName': 'Bentivenga', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Grandi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fogacci', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': ""Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.""}]","Diseases (Basel, Switzerland)",['10.3390/diseases8030026']
2547,32650518,"Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial.","Background and Objectives:  Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders; it has a great impact on patient quality of life and is difficult to treat satisfactorily. This study evaluates the efficacy and safety of trimebutine maleate (TM) in patients with FD.  Materials and Methods : Α multicenter, randomized, double-blind, placebo controlled, prospective study was conducted, including 211 patients with FD. Participants were randomized to receive TM 300 mg twice per day (BID, 108 patients) or placebo BID (103 patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot secondary endpoint, a substudy (eight participants on TM and eight on placebo) was conducted in to evaluate gastric emptying (GE), estimated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test.  Results : Of the 211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed. The groups did not differ in their demographic and medical history data. Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02). The 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing showed that TM significantly accelerated GE obtained at 50 min (median emptying 75.5% in the TM group vs. 66.6% in the placebo group,  p  = 0.036). Adverse effects of low to moderate severity were reported in 12.3% of the patients on TM.  Conclusion : TM monotherapy appears to be an effective and safe approach to treating FD, although the findings presented here warrant further confirmation.",2020,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","['211 patients with FD', '211 patients enrolled, 185 (87.7%) (97 (52.4%) in the TM group and 88 (47.6%) in the placebo group) completed the study and were analyzed', 'Functional Dyspepsia', 'patients with FD']","['Placebo', 'Trimebutine Maleate Monotherapy', 'Functional dyspepsia (FD', 'TM monotherapy', 'TM', 'trimebutine maleate (TM', 'placebo BID', 'placebo']","['relief of dyspepsia symptoms', 'efficacy and safety', 'Glasgow Dyspepsia Severity Score (GDSS', 'GDSS', 'gastric emptying (GE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0877833', 'cui_str': 'Trimebutine maleate'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}]",211.0,0.534728,"Regarding symptom relief, being the primary endpoint, a statistically significant reduction in GDSS for the TM group was revealed between the first (2-week) and final (4-week) visit ( p -value = 0.02).","[{'ForeName': 'Jannis', 'Initials': 'J', 'LastName': 'Kountouras', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gavalas', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Apostolis', 'Initials': 'A', 'LastName': 'Papaefthymiou', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsechelidis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Bor', 'Affiliation': 'Division of Gastroenterology, Ege University School of Medicine, 35330 Izmir, Turkey.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Diculescu', 'Affiliation': 'Gastroenterology and Hepatology Department, Clinic Fundeni Institute, 4204003 Bucharest, Romania.'}, {'ForeName': 'Κhaled', 'Initials': 'Κ', 'LastName': 'Jadallah', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Mazurek', 'Initials': 'M', 'LastName': 'Tadeusz', 'Affiliation': 'Medicor Centrum, ul. Jabłoskiego 2/4 35-068 Rzeszów, Poland.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Karakan', 'Affiliation': 'Department of Gastroenterology, Gazi University School of Medicine, 06560 Ankara, Turkey.'}, {'ForeName': 'Αnna', 'Initials': 'Α', 'LastName': 'Bochenek', 'Affiliation': 'Centrum Badawcze Wspolczesnej Terapii, 02679 Warszawa, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Rozciecha', 'Affiliation': 'LexMedica, Rudolfa Weigla 12, Krzyki, 53114 Wrocław, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dabrowski', 'Affiliation': 'Department of Rheumatology of Clinical Hospital 2, University of Rzeszow, Lwowska 60, 35-301 Rzeszow, Poland.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': 'Third Medical Clinic, University of Medicine and Pharmacy, Croitorilor Street no.19-21, 400162 Cluj-Napoca, Romania.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Sezgin', 'Affiliation': 'Mersin University, Faculty of Medicine, Department of Gastroenterology, 33343 Mersin, Turkey.'}, {'ForeName': 'Macit', 'Initials': 'M', 'LastName': 'Gülten', 'Affiliation': 'Department of Gastroenterology, Uludag University, 16059 Bursa, Turkey.'}, {'ForeName': 'Niazy Abu', 'Initials': 'NA', 'LastName': 'Farsakh', 'Affiliation': 'Department of Internal Medicine, King Abdullah University Hospital, 22110 Irbid, Jordan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doulberis', 'Affiliation': 'Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, 54642 Thessaloniki, Macedonia, Greece.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56070339']
2548,32650548,A Multidisciplinary Approach for Improving Quality of Life and Self-Management in Diabetic Kidney Disease: A Crossover Study.,"Individuals with diabetic kidney disease are at high risk of complications and challenged to self-manage. Previous research suggested that multidisciplinary approaches would improve health outcomes. This study investigated the effect of a multidisciplinary self-management approach of diabetic kidney disease on quality of life, and self-management, glycemic control, and renal function. A uniform balanced crossover design was used because it attains a high level of statistical power with a lower sample size. A total of 32 participants (aged 67.8 ± 10.8) were randomized into four study arms. In differing sequences, each participant was treated twice with three months of usual care alternated with three months of multidisciplinary management. The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  p  = 0.002, 56.84 vs. 37.02;  p  = 0.000, 53.84 vs. 39.77;  p  = 0.008; 95% CI). Antihypertensive medication engagement was high across the study period (Mean = 95.38%, Min = 69%, Max = 100%). Glycemic control and renal function indicators were similar for the intervention and the usual care. Studies are needed to determine how the new recommended therapies for diabetic kidney disease such as SGLT2 inhibitors and GLP-1 receptor agonists impact on self-management and quality of life.",2020,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","['Diabetic Kidney Disease', '32 participants (aged 67.8 ± 10.8', 'Individuals with diabetic kidney disease']",['multidisciplinary self-management approach'],"['Antihypertensive medication engagement', 'Glycemic control and renal function indicators', 'Quality of Life and Self-Management', 'self-care activities, general diet habits, diabetes diet habits, and blood sugar testing', 'health outcomes', 'quality of life, and self-management, glycemic control, and renal function', 'present dimension of quality of life']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",32.0,0.0424056,"The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01;  p  = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31;  ","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Helou', 'Affiliation': 'School of Health Sciences (HESAV), HES-SO University of Applied Sciences and Arts Western Switzerland, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Talhouedec', 'Affiliation': 'Clinique de La Source, 1004 Lausanne, Switzerland.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zumstein-Shaha', 'Affiliation': 'Department of Health, Bern University of Applied Sciences, 3010 Bern, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zanchi', 'Affiliation': 'Service of Nephrology and Hypertension, Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9072160']
2549,32650604,Nine Months of a Structured Multisport Program Improve Physical Fitness in Preschool Children: A Quasi-Experimental Study.,"Research in preschool children that investigates the impact of different exercise interventions on physical fitness is limited. This pre-post study was aimed at determining if participation in a nine-month structured multisport program (MSG; n = 38) could enhance physical fitness components compared to a formal exercise program (control group (CG); n = 36) among preschool children. Physical fitness was assessed using standardized tests (the standing long jump, sit and reach, 20 m sprint, sit-ups for 30 s, bent-arm hang, medicine ball throw (MBT), grip strength, 4 × 10 m shuttle run, and 20 m shuttle run tests). The structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week. The control group was free of any programmed exercise except for the obligatory program in kindergartens. A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05). There was no significant group-by-time interaction effect for the 20 m sprint test ( p  = 0.794) or for the 20 m shuttle run test ( p  = 0.549). Moreover, the MSG and CG performance in the MBT and 20 m shuttle run tests improved to a similar extent from pre- to post-test. Our results indicate that compared to the formal plan, the structured multisport program led to a sustained improvement in physical fitness in healthy 5-to-6-year old children.",2020,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","['Preschool Children', 'n = 36) among preschool children', 'healthy 5-to-6-year old children', 'preschool children']","['structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week', 'exercise interventions', 'Structured Multisport Program', 'physical fitness components compared to a formal exercise program (control group (CG']","['Physical Fitness', 'time interaction effect', 'physical fitness', 'Physical fitness', 'MSG and CG performance']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",38.0,0.019258,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Popović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Cvetković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Tijana', 'Initials': 'T', 'LastName': 'Šćepanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Čokorilo', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Belić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Andrašić', 'Affiliation': 'Faculty of Economics, University of Novi Sad, 24000 Subotica, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17144935']
2550,32650671,Editorial: Clinical trial design in the era of COVID-19.,,2020,,[],[],[],[],[],[],,0.137778,,"[{'ForeName': 'Colin B', 'Initials': 'CB', 'LastName': 'Begg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gonen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Heitjan', 'Affiliation': 'Department of Statistical Science, Southern Methodist University, Dallas, TX, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520940230']
2551,32650673,Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.,"BACKGROUND


Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.
METHODS


Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.
RESULTS


At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.
DISCUSSION


Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.",2020,Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.,['48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments'],['acupuncture'],[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1556023', 'cui_str': 'Acupuncturist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.36601,Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.,"[{'ForeName': 'Alana D', 'Initials': 'AD', 'LastName': 'Steffen', 'Affiliation': 'Department of Health Systems Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Larisa A', 'Initials': 'LA', 'LastName': 'Burke', 'Affiliation': 'Office of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Pauls', 'Affiliation': 'Office of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marie L', 'Initials': 'ML', 'LastName': 'Suarez', 'Affiliation': 'Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Kobak', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yajima', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nobuari', 'Initials': 'N', 'LastName': 'Takakura', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Schlaeger', 'Affiliation': 'Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520934910']
2552,32650682,Endoscopic myringoplasty in pediatric patients: a comparison of cartilage graft push-through and underlay fascia graft techniques.,"BACKGROUND


Although myringoplasty is performed in pediatric patients, there is still no consensus on the graft material and surgerical procedure.
OBJECTIVE


To compare the short-and long- term graft take rates of the cartilage push-through and fascia graft techniques employed during pediatric myringoplasty.
MATERIALS AND METHODS


93 pediatric patients with perforation who underwent myringoplasty were randomized into the cartilage push-through and underlay fascia graft group. The outcomes evaluated were hearing gains, and graft success rates at 12 and 24 months.
RESULTS


The graft success rate was similar between two groups (95.7% vs 91.3%,  p  = .653) at postoperative 12th months, however, the graft success rate was significantly higher 91.5% for the cartilage graft group compared with 73.9% for the fascia group at postoperative 24th months. No significant between-group differences were observed pre- ( p  = .694) or post- ( p  = .812) operative ABG values or mean ABG gain ( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%). No middle ear cholesteatoma formation was found in either group.
CONCLUSION


Endoscopic cartilage push-through and underlay fascia graft myringoplasty afforded comparable hearing results in pediatric patients; however, the push-through technique without the elevation of a tympanomeatal flap exhibited better long-term graft success rate compared to underlay fascia graft.",2020,( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%).,"['93 pediatric patients with perforation who underwent myringoplasty', 'pediatric patients']","['cartilage push-through and underlay fascia graft group', 'Endoscopic myringoplasty', 'cartilage graft push-through and underlay fascia graft techniques']","['operative ABG values or mean ABG gain', 'graft success rate', 'hearing gains, and graft success rates', 'perforation rate', 'middle ear cholesteatoma formation']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0444455', 'cui_str': 'Underlay'}, {'cui': 'C0185473', 'cui_str': 'Grafting of fascia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0155490', 'cui_str': 'Cholesteatoma of middle ear'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",93.0,0.0802185,( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%).,"[{'ForeName': 'Zhengcai', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Affiliated Yiwu Hospital of Wenzhou Medical University (Yiwu Central Hospital), Yiwu City, China.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1787510']
2553,32650683,"Antithymocyte Globulin for Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies: A Multicenter, Open-Label, Randomized Controlled Study.","PURPOSE


The role of antithymocyte globulin (ATG) in preventing acute graft-versus-host disease (aGVHD) after HLA-matched sibling donor transplantation (MSDT) is still controversial.
PATIENTS AND METHODS


We performed a prospective, multicenter, open-label, randomized controlled trial (RCT) across 23 transplantation centers in China. Patients ages 40-60 years with standard-risk hematologic malignancies with an HLA-matched sibling donor were randomly assigned to an ATG group (4.5 mg/kg thymoglobulin plus cyclosporine [CsA], methotrexate [MTX], and mycophenolate mofetil [MMF]) and a control group (CsA, MTX, and MMF). The primary end point of this study was grade 2-4 aGVHD on day 100.
RESULTS


From November 2013 to April 2018, 263 patients were enrolled. The cumulative incidence rate of grade 2-4 aGVHD was significantly reduced in the ATG group (13.7%; 95% CI, 13.5% to 13.9%) compared with the control group (27.0%; 95% CI, 26.7% to 27.3%;  P  = .007). The ATG group had significantly lower incidences of 2-year overall chronic GVHD (27.9% [95% CI, 27.6% to 28.2%]  v  52.5% [95% CI, 52.1% to 52.9%];  P  < .001) and 2-year extensive chronic GVHD (8.5% [95% CI, 8.4% to 8.6%]  v  23.2% [95% CI, 22.9% to 23.5%];  P  = .029) than the control group. There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival. Three-year GVHD relapse-free survival was significantly improved in the ATG group (38.7%; 95% CI, 29.9% to 47.5%) compared with the control group (24.5%; 95% CI, 16.9% to 32.1%;  P  = .003).
CONCLUSION


Our study is the first prospective RCT in our knowledge to demonstrate that ATG can effectively decrease the incidence of aGVHD after MSDT in the CsA era without affecting the CIR or NRM.",2020,"There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival.","['Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies', '23 transplantation centers in China', 'Patients ages 40-60 years with standard-risk hematologic malignancies with an HLA-matched sibling donor', 'From November 2013 to April 2018, 263 patients were enrolled']","['control group (CsA, MTX, and MMF', 'Antithymocyte Globulin', 'antithymocyte globulin (ATG', 'HLA-matched sibling donor transplantation (MSDT', 'ATG group (4.5 mg/kg thymoglobulin plus cyclosporine [CsA], methotrexate [MTX], and mycophenolate mofetil [MMF']","['GVHD relapse-free survival', '2-year extensive chronic GVHD', 'cumulative incidence rate of grade 2-4 aGVHD', 'cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival', '2-year overall chronic GVHD']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0730920', 'cui_str': 'Thymoglobulin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}]",263.0,0.178938,"There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival.","[{'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}, {'ForeName': 'De-Pei', 'Initials': 'DP', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yong-Rong', 'Initials': 'YR', 'LastName': 'Lai', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Qi-Fa', 'Initials': 'QF', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu-Qian', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory for Medical Genomics, Department of Hematology, Shanghai Institute of Hematology, and Collaborative Innovation Center of Hematology, Rui-Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital Affiliated With Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shun-Qing', 'Initials': 'SQ', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Dong-Jun', 'Initials': 'DJ', 'LastName': 'Lin', 'Affiliation': 'Third Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Ren', 'Affiliation': 'Department of Hematology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Fang-Pin', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Xinqiao Hospital Affiliated to Third Military Medical University, Chongqing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Yong-Ping', 'Initials': 'YP', 'LastName': 'Song', 'Affiliation': 'The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jian-Da', 'Initials': 'JD', 'LastName': 'Hu', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying-Min', 'Initials': 'YM', 'LastName': 'Liang', 'Affiliation': ""Tangdu Hospital Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Jing-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Southern Theater General Hospital of the Chinese People's Liberation Army, Guangzhou, China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00150']
2554,32650729,Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.,"BACKGROUND


Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.
METHODS


Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment.
RESULTS


The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product.
CONCLUSION


Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered.
TRIAL REGISTRATION


This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).",2020,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","['Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs', 'women with bacterial vaginosis', 'vaginal health in South Africa', '17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ', 'BV+ (Nugent 7-10) but STI- women']","['commercial probiotic supplementation', 'metronidazole followed by a commercial oral/vaginal probiotic', 'commercial oral-vaginal-combination probiotic', 'vaginal metronidazole alone']","['BV recurrence, symptoms, vaginal microbiota and genital cytokine changes', 'BV cure', 'Acceptability and adherence', 'acceptability of vaginal application', 'recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations', 'HIV risk and adverse reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}]","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.359196,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","[{'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa. anna.happel@uct.ac.za.'}, {'ForeName': 'Ravesh', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Nireshni', 'Initials': 'N', 'LastName': 'Mitchev', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}]",BMC infectious diseases,['10.1186/s12879-020-05210-4']
2555,32650732,Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial.,"BACKGROUND


Older adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
METHODS


Participants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions.
DISCUSSION


A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population.
TRIAL REGISTRATION


# NCT03157999 . Registration Date: April 4, 2017.",2020,"The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
","['Older adults (> 65\u2009years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home', '216 eligible and consenting participants', 'Participants will be considered eligible if they are >\u200965\u2009years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms', 'older adults with MCC and depressive symptoms transitioning from hospital-to-home', 'older adults with multiple chronic conditions and depressive symptoms', 'older adult and caregiver participants']","['tailored care delivery comprising in-home visits, telephone follow-up and system navigation support', 'Community Assets Supporting Transitions (CAST', 'hospital-to-home transitional care intervention', 'control (usual care) or intervention (CAST']","['caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs', 'changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",216.0,0.129255,"The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.
","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada. mreid@mcmaster.ca.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'Murray Alzheimer Research & Education Program (MAREP), School of Public Health and Health Systems, University of Waterloo,University of Waterloo Research Institute for Aging, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ganann', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact; and Centre for Health Economics and Policy Analysis, McMaster University, 1200 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Alain P', 'Initials': 'AP', 'LastName': 'Gauthier', 'Affiliation': 'School of Human Kinetics, Laurentian University, 935 Ramsey Lake Rd., Sudbury, ON, P3E 2C6, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Heald-Taylor', 'Affiliation': 'Patient Research Partner, Selkirk, ON, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McElhaney', 'Affiliation': 'Medical Sciences Division, Northern Ontario School of Medicine, Health Sciences North Research Institute, 41 Ramsey Lake Road, Sudbury, ON, P3E 5J1, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Urajnik', 'Affiliation': 'Centre for Rural and Northern Health Research, Laurentian University, 935 Ramsey Lake Rd., Sudbury, ON, P3E 2C6, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Whitmore', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1200 Main Street West, HSC 3N25B, Hamilton, ON, L8S 4K1, Canada.'}]",BMC geriatrics,['10.1186/s12877-020-01638-0']
2556,32650750,Three-dimensional printing of patient-specific plates for the treatment of acetabular fractures involving quadrilateral plate disruption.,"BACKGROUND


Complicated acetabular fractures comprise the most challenging field for orthopedists. The purpose of this study was to develop three-dimensional printed patient-specific (3DPPS) Ti-6Al-4 V plates to treat complicated acetabular fractures involving quadrilateral plate (QLP) disruption and to evaluate their efficacy.
METHODS


Fifty patients with acetabular fractures involving QLP disruption were selected between January 2016 and June 2017. Patients were divided into a control group (Group A, 35 patients) and an experimental group (Group B, 15 patients), and were treated by the conventional method of shaping reconstruction plates or with 3DPPS Ti-6AL-4 V plates, respectively. The efficacy of Ti-6AL-4 V plates was evaluated by blood loss, operative time, reduction quality, postoperative residual displacement, and complications.
RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05). There was no significant difference in reduction quality between the two groups (P > 0.05). Reduction quality in Group B was anatomic in 10 (66.7%), satisfactory in four (26.7%), and poor in one (6.7%). In Group A, they were anatomic in 18 (51.4%), satisfactory in 13 (37.1%), and poor in four (11.4%). Residual displacement in Group B was less than that in Group A, and the difference was statistically significant (P < 0.05). In Group B, one case exhibited loosening of the pubic screw postoperatively. In Group A, there was one case of wound infection, one of deep vein thrombosis (DVT) in the ipsilateral lower limb, one case of traumatic arthritis and two obturator nerve injuries.
CONCLUSIONS


The 3DPPS Ti-6AL-4 V plate is a feasible, accurate and effective implant for acetabular fracture treatment.",2020,"RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05).",['Fifty patients with acetabular fractures involving QLP disruption were selected between January 2016 and June 2017'],"['Ti-6AL-4\u2009V plates', 'conventional method of shaping reconstruction plates or with 3DPPS Ti-6AL-4\u2009V plates, respectively']","['operative time and blood loss', 'blood loss, operative time, reduction quality, postoperative residual displacement, and complications', 'reduction quality', 'wound infection, one of deep vein thrombosis (DVT', 'Reduction quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",50.0,0.0148256,"RESULTS


The operative time and blood loss in Group B were reduced compared to Group A, and the difference was statistically significant (P < 0.05).","[{'ForeName': 'Canbin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'School of Mechanical and Automotive Engineering, South China University of Technology, Guangzhou, 510640, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Fuming', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China. fanscyi@sohu.com.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital of Southern Medical University, 183 Zhongshan Dadao West Street, Guangzhou, 510600, Guangdong, China. orthobiomech@163.com.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Hand Surgery, and Department of Plastic Reconstructive Surgery, Ningbo No. 6 Hospital, Ningbo, 315040, China. jianghui.dong@mymail.unisa.edu.au.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03370-7']
2557,32650760,Evaluating the effectiveness of a CRSCE-based de-escalation training program among psychiatric nurses: a study protocol for a cluster randomized controlled trial.,"BACKGROUND


The high incidence of workplace violence (WPV) in clinical mental health settings has caused a series of negative impacts on nurses, which has subsequently increased public concern. De-escalation (DE) is recommended as a training program which aims at providing nurses with skills and strategies to more effectively respond and manage WPV. Very few studies have examined the effectiveness of DE training, with current studies possessing various limitations due to their design and small sample sizes. By using a cluster randomized controlled design, the proposed study aims to evaluate the effectiveness of a CRCSE-based DE training programs among psychiatric nurses.
METHOD


A cluster randomized controlled trial, with a 6-month follow-up period after the end of the intervention, will be conducted among psychiatric hospitals in Guangdong, China. The randomization unit is each involved psychiatric hospital. Participants in the control group will be assigned to routine WPV management training, participants of the intervention group will undergo the same training while additionally receiving DE training. The DE training will include the following five modules: communication, response, solution, care, and environment (CRSCE). Primary outcomes are objective clinical indicators, which will be extracted from the information systems of the enrolled hospitals. These include the incidence of WPV, injuries caused by WPV, and the use of coercion (physical restraint and seclusion) by nurses. Secondary outcomes, aims at evaluating the effects of DE training on nurses, include the capacity of DE, DE confidence, level of job burnout, and professional quality of life. Data will be collected at baseline (T 0 ), at 3 months (T 1 , intervention completed), and at 6 months after intervention (T 2 , follow-up).
DISCUSSION


This study will offer trial-based evidence of the efficacy of a DE training program targeted at WPV among psychiatric nurses. DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900022211 . Prospectively registered on 30 March 2019.",2020,"DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
","['psychiatric nurses', 'psychiatric hospitals in Guangdong, China']","['CRSCE-based de-escalation training program', 'DE training program', 'CRCSE-based DE training programs', 'DE training', 'routine WPV management training, participants of the intervention group will undergo the same training while additionally receiving DE training']","['effects of DE training on nurses, include the capacity of DE, DE confidence, level of job burnout, and professional quality of life']","[{'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0983117,"DE training is expected to reduce both the total incidence and negative impacts of WPV, with additional improvements in psychiatric nurses' coping skills.
","[{'ForeName': 'Junrong', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China. yejunrong1580@qq.com.'}, {'ForeName': 'Aixiang', 'Initials': 'A', 'LastName': 'Xiao', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Early Intervention, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Zhichun', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Adult Psychiatry, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Sijue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Jiankui', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing Administration, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, 510370, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yun Lei', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingzhou Central Hospital, Jingzhou, China.'}]",BMC health services research,['10.1186/s12913-020-05506-w']
2558,32650771,Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial.,"BACKGROUND


Despite the numerous healthcare smartphone applications for self-management of diabetes, patients often fail to use these applications consistently due to various limitations, including difficulty in inputting dietary information by text search and inconvenient and non-persistent self-glucose measurement by home glucometer. We plan to apply a digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS) to overcome those limitations. Furthermore, medical staff will be performing monitoring and intervention to encourage continuous use of the program. The aim of this trial is to examine the efficacy of the program in patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53-69 mmol/mol (7.0-8.5%) and body mass index (BMI) ≥ 23 mg/m 2 .
METHODS


This is a 48-week, open-label, randomized, multicenter trial consisting of patients with type 2 diabetes. The patients will be randomly assigned to three groups: control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff. There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48. The primary end point is change in HbA1c from baseline to six months after the intervention.
DISCUSSION


This trial will verify the effectiveness of a digital integrated healthcare platform with an AI-driven dietary solution and a real-time CGMS in patients with T2DM.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04161170, registered on 08 November 2019. https://clinicaltrials.gov/ct2/show/NCT04161170?term=NCT04161170&draw=2&rank=1.",2020,"There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48.","['diabetes management', 'registered on 08 November 2019', 'patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53-69\u2009mmol/mol (7.0-8.5%) and body mass index (BMI)\u2009≥\u200923\u2009mg/m 2 .\nMETHODS', 'patients with type 2 diabetes', 'patients with T2DM']","['digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system', 'control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff', 'digital integrated healthcare platform with an AI-driven dietary solution', 'digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS']",['change in HbA1c'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0666465,"There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48.","[{'ForeName': 'Sung Woon', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gyuri', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'You-Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woo Je', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyunjin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Amazing Food Solution, Inc., Seoul, South Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. jaehyeon@skku.edu.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01179-x']
2559,32650801,Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up.,"BACKGROUND


Osteoarthritis is the most prevalent type of arthritis, which significantly impacts the patient's mobility and quality of life. Pharmacological treatments for osteoarthritis, such as corticosteroids, produce an immediate reduction of the patient's pain as well as an improvement in the patient's mobility and quality of life, but with a limited long-term efficacy. In this context, platelet-rich plasma (PRP) infiltrations represent a therapeutic tool due to its trophic properties and its ability to control inflammatory processes, especially in musculoskeletal applications. The aim of this study is to evaluate and compare the clinical benefits of PRP when injected intra-articularly vs a commonly used corticosteroid (CS, triamcinolone acetonide, Kenalog®) in patients affected by mild to moderate symptomatic knee osteoarthritis.
METHODS


Forty patients affected by symptomatic radiologically confirmed knee osteoarthritis (Kellgren-Lawrence grades II-III) were enrolled in this randomized study. Patients randomized in the PRP group (n = 20) received an intra-articular injection of PRP (8 mL) while patients randomized in the CS group (n = 20) received an intra-articular injection of triamcinolone acetonide (1 mL of 40 mg/mL) plus lidocaine (5 mL of 2%). The pain and function of the target knee were evaluated by the VAS, IKDC, and KSS scales at the baseline (V1), 1 week (V2), 5 weeks (V3), 15 weeks (V4), 30 weeks (V5), and 1 year (V6) after treatment.
RESULTS


No serious adverse effects were observed during the follow-up period. A mild synovitis was registered in 15 patients (75%) in the PRP group within the first week after treatment which resolved spontaneously. Both treatments were effective in relieving pain and improving the knee function in the very short-term follow-up visit (1 week). A high improvement of the subjective scores was observed for both groups up to 5 weeks, with no significative differences between the groups for the VAS, IKDC, or KSS. After 15 weeks of follow-up, the PRP group showed significative improvements in all scores when compared to the CS group. Overall, the patients who received PRP treatment had better outcomes in a longer follow-up visit (up to 1 year) than those who received CS.
CONCLUSIONS


A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups). PRP demonstrated a statistically significant improvement over CS in a 1-year follow-up. This study was registered at ISRCTN with the ID ISRCTN46024618.",2020,A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups).,"['patients affected by mild to moderate symptomatic knee osteoarthritis', 'moderate knee osteoarthritis', 'Forty patients affected by symptomatic radiologically confirmed knee osteoarthritis (Kellgren-Lawrence grades II-III']","['PRP', 'triamcinolone acetonide (1\u2009mL of 40\u2009mg/mL) plus lidocaine', 'Intra-articular platelet-rich plasma vs corticosteroids', 'corticosteroid (CS, triamcinolone acetonide, Kenalog®', 'intra-articular injection of PRP']","['pain and function of the target knee', 'knee function', 'mild synovitis', 'VAS, IKDC, and KSS scales', 'subjective scores', 'relieving pain', 'serious adverse effects']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0699689', 'cui_str': 'Kenalog'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.042986,A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups).,"[{'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Elksniņš-Finogejevs', 'Affiliation': 'Faculty of Continuing Education, Rīga Stradiņš University, Riga, Latvia. andrejs.finogejevs@orto.lv.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vidal', 'Affiliation': 'Laboratorios Fidia Farmacéutica S.L.U, Madrid, Spain.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Peredistijs', 'Affiliation': '""ORTO klinika"" Ltd., Riga, Latvia.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01753-z']
2560,32650814,Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial.,"BACKGROUND


The prevalence of pneumonia complicating stroke in acute phase has a poor prognosis and higher risk for death. Oral opportunistic pathogens have been reported to be associated with pneumonia among people with compromised health. Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens. This study evaluates the effectiveness of oral health promotions in reducing the prevalence of pneumonia via its effects on composition and relative abundance of oral opportunistic pathogens.
METHODS/DESIGN


This study is a randomized, single-blind, parallel trial of 6 months duration. The study is being conducted at one of the largest medical teaching hospitals in Hefei, China. A total of 166 patients with stroke and free from any post-stroke complication will be recruited. After enrollment, patients will be randomized to one of the following groups: (1) oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse (10 ml twice daily). The primary outcome is the prevalence of pneumonia complicating stroke. Patients will be monitored closely for any occurrence of pneumonia over the entire period of this trial. Oral rinse samples will be collected at baseline and multiple follow-up reviews (3, 5, 7 days, and 1, 3, 6 months after baseline). Next-generation sequencing will be employed to detect composition and relative abundances of the microorganism in the oral rinse samples. Questionnaire interviews and clinical oral examinations will be conducted at baseline and 1, 3, and 6 months after baseline.
DISCUSSION


The findings of this trial will provide evidence whether oral health promotion intervention is effective in reducing the prevalence of pneumonia complicating stroke via its effect on the oral microbiome. The analysis of the outcomes of this trial is empowered by metagenomic analysis at 16S rRNA level, which is more sensitive and comprehensive to help us detect how oral health promotion inventions affect the oral microbiome in terms of its composition, relative abundance, and interactions between species, which all may contribute to the occurrence of pneumonia complicating stroke.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04095780 . Registered on 19 September 2019.",2020,"Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens.","['166 patients with stroke and free from any post-stroke complication will be recruited', 'patients with stroke in acute phase', 'people with compromised health', 'largest medical teaching hospitals in Hefei, China', 'patients with stroke']","['Oral health promotion', 'oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse', 'oral health promotions', 'oral health promotion interventions', 'oral health promotion intervention']",['prevalence of pneumonia complicating stroke'],"[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0150290', 'cui_str': 'Oral health promotion'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",166.0,0.247406,"Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens.","[{'ForeName': 'Juncang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Yuanchang', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Edward C M', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Department of Dental Public Health, Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong.'}, {'ForeName': 'Yinliang', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Quan-Li', 'Initials': 'QL', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China. ql-li@126.com.'}, {'ForeName': 'Ruoxi', 'Initials': 'R', 'LastName': 'Dai', 'Affiliation': ""The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China. u3001283@connect.hku.hk.""}]",Trials,['10.1186/s13063-020-04528-3']
2561,32647985,Prospective Randomized Study on Stapled Anopexy Height and Its Influence on Recurrence for Hemorrhoidal Disease Treatment.,"OBJECTIVES


To know the influence of the stapled line height (SLH) in the recurrence rate and the postoperative disturbances in stapled anopexy (SA) for the treatment of hemorrhoids.
DESIGN


Simple randomized double-blind controlled clinical trial. Randomization with closed-envelope technique in two groups with two different SLH.
SETTING


Colorectal Surgery Unit. Department of General Surgery. Hospital de Mataró (Barcelona, Spain).
PARTICIPANTS


119 patients with the diagnosis of symptomatic third- and fourth-grade hemorrhoids were included.
INTERVENTION


SA was performed with two different SLH: group A, 4.5 cm (58 patients) and group B, 6 cm (61 patients) from the external anal verge. Postoperative disturbances were evaluated by a colorectal surgeon who was blind for the randomization and pain was measured (visual analogic scale) one week and 3 months after surgery. Mean operative time, number of hemostatic stitches performed and resected mucosal area were considered as well. Mean follow-up was 11.05 ± 1.6 years.
RESULTS


Differences between the operative time and resected mucosa-submucosa area were not found. The patients of group A needed a significantly higher number of stitches for intraoperative bleeding control along the stapled line. We did not found differences between both groups in terms of postoperative pain neither anorectal disturbances. At the follow-up, persistence of symptomatology was 10.41% in group A and 10.71% in group B, without statistically significance. Neither mortality nor undesirable effects occurred in the series.
CONCLUSIONS


SLH do not influence the recurrence rate neither the postoperative evolution in SA.
TRIAL REGISTRATION


Clinical Trials NCT03383926.",2020,The patients of group A needed a significantly higher number of stitches for intraoperative bleeding control along the stapled line.,"['Colorectal Surgery Unit', '119 patients with the diagnosis of symptomatic third- and fourth-grade hemorrhoids were included']","['stapled line height (SLH', 'Stapled Anopexy Height', 'stapled anopexy (SA']","['Mean operative time, number of hemostatic stitches performed and resected mucosal area', 'number of stitches for intraoperative bleeding control', 'postoperative pain neither anorectal disturbances', 'persistence of symptomatology', 'mortality nor undesirable effects', 'recurrence rate', 'operative time and resected mucosa-submucosa area', 'Postoperative disturbances']","[{'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0225344', 'cui_str': 'Tunica submucosa'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",119.0,0.175284,The patients of group A needed a significantly higher number of stitches for intraoperative bleeding control along the stapled line.,"[{'ForeName': 'Luis Antonio', 'Initials': 'LA', 'LastName': 'Hidalgo-Grau', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}, {'ForeName': 'Encarna', 'Initials': 'E', 'LastName': 'Piedrafita-Serra', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain. eps4681@comg.cat.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Ruiz-Edo', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Llorca-Cardeñosa', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Heredia-Budó', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Estrada-Ferrer', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Suñol-Sala', 'Affiliation': 'Colorectal Surgery Unit, Department of General and Digestive, Hospital de Mataró, Barcelona, Spain.'}]",World journal of surgery,['10.1007/s00268-020-05676-y']
2562,32648019,"Correction to: Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12 week, randomized, parallel-design intervention study.",ue to author error the paper was published wit.,2020,ue to author error the paper was published wit.,['healthy Swedish females'],['wholegrain bread'],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}]",[],,0.0171175,ue to author error the paper was published wit.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02286-1']
2563,32648021,"Reply to the comments by Vorland et al. on our paper: ""low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0128649,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Lincoln Research Centre, AgResearch, Springs Road, Lincoln, Christchurch, New Zealand.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02288-z']
2564,32648022,"Short-term, but not acute, intake of New Zealand blackcurrant extract improves insulin sensitivity and free-living postprandial glucose excursions in individuals with overweight or obesity.","Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity. Acute ingestion of anthocyanins improves postprandial glucose responses to a single carbohydrate-rich meal under strictly controlled conditions.
PURPOSE


Examine whether acute and short-term supplementation with anthocyanin-rich New Zealand blackcurrant (NZBC) extract can improve postprandial glucose responses to mixed-macronutrient meals.
METHODS


Twenty-five overweight (BMI > 25 kg m 2 ) sedentary individuals participated in one of the following double-blinded, randomised controlled trials: (1) ingestion of 600 mg NZBC extract or placebo prior to consumption of a high-carbohydrate, high-fat liquid meal (n = 12); (2) 8-days supplementation with NZBC extract (600 mg day -1 ) or placebo, with insulin sensitivity and markers of inflammation assessed on day-7, and free-living postprandial glucose (continuous glucose monitoring) assessed on day-8 (n = 13).
RESULTS


A single dose of NZBC extract had no effect on 3 h postprandial glucose, insulin or triglyceride responses. However, in response to short-term NZBC extract supplementation insulin sensitivity was improved (+ 22%; P = 0.011), circulating C-reactive protein concentrations decreased (P = 0.008), and free-living postprandial glucose responses to both breakfast and lunch meals were reduced (- 9% and - 8%, respectively; P < 0.05), compared to placebo.
CONCLUSION


These novel results indicate that repeated intake, rather than a single dose of NZBC extract, is required to induce beneficial effects on insulin sensitivity and postprandial glucose handling in individuals with overweight or obesity. Continuous glucose monitoring enabled an effect of NZBC extract to be observed under free-living conditions and highlights the potential of anthocyanin-rich supplements as a viable strategy to reduce insulin resistance.",2020,Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity.,"['Twenty-five', 'overweight', 'individuals with overweight or obesity']","['placebo, with insulin sensitivity and markers of inflammation assessed on day-7, and free-living postprandial glucose (continuous glucose monitoring) assessed on day-8 (n\u2009=\u200913', 'anthocyanins', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract', 'NZBC extract or placebo prior to consumption of a high-carbohydrate, high-fat liquid meal (n\u2009=\u200912); (2) 8-days supplementation with NZBC extract']","['insulin sensitivity and free-living postprandial glucose excursions', 'circulating C-reactive protein concentrations', 'free-living postprandial glucose responses to both breakfast and lunch meals', '3\xa0h postprandial glucose, insulin or triglyceride responses', 'NZBC extract supplementation insulin sensitivity', 'postprandial glucose responses']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",,0.180277,Impaired postprandial glucose handling and low-grade systemic inflammation are risk factors for developing insulin resistance in individuals with overweight or obesity.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brett', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Strauss', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Stewart', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Shepherd', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK. S.Shepherd@ljmu.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-020-02329-7']
2565,32648072,Evolution of Patiromer Use: a Review.,"PURPOSE OF REVIEW


The purpose of this review is to present data from clinical trials that resulted in the key data supporting the use of patiromer as a potassium binder in clinical practice today.
RECENT FINDINGS


In addition to trials that support the current Food and Drug Administration label and published over the past 3 years, the recently published Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease (AMBER) trial provides clear benefits of patiromer use in a group of resistant hypertension patients. The AMBER was a phase 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated 295 participants stratified by local serum potassium measurement (4.3 to < 4.7 mmol/L vs 4.7 to 5.1 mmol/L) and history of diabetes and chronic kidney disease. The focus was on enabling participants with resistant hypertension to achieve blood pressure goals by using spironolactone. Additionally, the ongoing Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND) trial is designed to demonstrate how patiromer is an ""enabler"" of therapies that are needed to either control resistant hypertension or reduce mortality in heart failure but generate hyperkalemia. These and other studies are discussed in detail. Patiromer is one of two new potassium binders that are far better tolerated than the previous agent and can be given chronically to participants who need life-saving therapies but have elevations of potassium into a dangerous range as a consequence.",2020,"(DIAMOND) trial is designed to demonstrate how patiromer is an ""enabler"" of therapies that are needed to either control resistant hypertension or reduce mortality in heart failure but generate hyperkalemia.","['Subjects Receiving RAASi Medications for the Treatment of Heart Failure', '295 participants stratified by local serum potassium measurement (4.3 to <\u20094.7\xa0mmol/L vs 4.7 to 5.1\xa0mmol/L) and history of diabetes and chronic kidney disease', 'participants with resistant hypertension to achieve blood pressure goals by using']","['Spironolactone With Patiromer', 'spironolactone', 'placebo']",[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],295.0,0.0476647,"(DIAMOND) trial is designed to demonstrate how patiromer is an ""enabler"" of therapies that are needed to either control resistant hypertension or reduce mortality in heart failure but generate hyperkalemia.","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Ali', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes and Metabolism and the Am. Heart Assoc. Comprehensive Hypertension Center, University of Chicago Medicine, 5841 S. Maryland Ave. MC 1027, Chicago, IL, 60637, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes and Metabolism and the Am. Heart Assoc. Comprehensive Hypertension Center, University of Chicago Medicine, 5841 S. Maryland Ave. MC 1027, Chicago, IL, 60637, USA. gbakris@gmail.com.'}]",Current cardiology reports,['10.1007/s11886-020-01342-w']
2566,32648100,Oral versus Injectable Antibiotics in Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis: A Pilot Randomized Controlled Trial.,"OBJECTIVE


To compare oral co-amoxiclav with injectable ampicillin and amikacin for the management of asymptomatic neonates born to mothers with risk factors for infection.
METHODS


This open label, randomized controlled trial was conducted in a tertiary care teaching hospital on neonates of gestational age ≥ 34 wk with maternal risk factors for infection, who were asymptomatic at birth and accepting breastfeeds. Newborns were randomized to receive either oral co-amoxiclav or injectable ampicillin and amikacin within 1-3 h after birth. Primary outcome variable was the development of clinical signs of sepsis with or without a positive blood culture by 72 h of life. Secondary outcome variables were development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy.
RESULTS


One hundred twenty-six newborns were randomized to receive either oral co-amoxyclav (n = 63) or injectable ampicillin and amikacin (n = 63). Data were analyzed on intention to treat basis. Both groups were comparable with respect to maternal and neonatal characteristics. Incidence of clinical sepsis within three days of age was similar between the groups [2 (3.2%) vs. 1 (1.6%) in injectable and oral groups, respectively; RR (95% CI) 0.500 (0.047-5.373); p = 0.567]. No significant difference was noted for the development of sepsis by 1 wk [1 (1.6%) vs. 0 in injectable and oral groups, respectively; RR (95% CI) 0.333 (0.014-8.03100); p = 0.499]. Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
CONCLUSIONS


Oral co-amoxyclav is as effective as injectable ampicillin and amikacin for management of asymptomatic neonates born to mothers with risk factors for infection.",2020,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","['Newborns', 'asymptomatic neonates born to mothers with risk factors for infection', 'Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis', 'One hundred twenty-six newborns', 'tertiary care teaching hospital on neonates of gestational age\u2009≥']","['oral co-amoxiclav or injectable ampicillin and amikacin', 'oral co-amoxiclav with injectable ampicillin and amikacin', 'oral co-amoxyclav (n\u2009=\u200963) or injectable ampicillin and amikacin', 'ampicillin and amikacin', 'Oral versus Injectable Antibiotics']","['development of clinical signs of sepsis with or without a positive blood culture by 72\xa0h of life', 'development of sepsis', 'Adverse drug reactions such as vomiting, diarrhea and skin rash', 'development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy', 'Incidence of clinical sepsis']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3164780', 'cui_str': 'Clinical sepsis'}]",126.0,0.188147,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. ashokkumar_bhu@hotmail.com.'}, {'ForeName': 'Abhishek Kumar', 'Initials': 'AK', 'LastName': 'Dubey', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India.'}, {'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03412-x']
2567,32648108,Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials.,"INTRODUCTION


This post hoc exploratory analysis examined the effects of ertugliflozin on liver enzymes in patients with type 2 diabetes mellitus (T2DM).
METHODS


Data were pooled from seven randomized, double-blind VERTIS phase 3 trials that evaluated ertugliflozin (5 mg and 15 mg) versus non-ertugliflozin (placebo, glimepiride, or sitagliptin) treatment in patients with T2DM. Change from baseline at week 52 of treatment in alanine and aspartate aminotransferase (ALT and AST, respectively) serum levels (overall and categorized into tertiles by baseline ALT and AST), Fibrosis-4 Index (FIB-4), glycated hemoglobin (HbA1c), and body weight were evaluated, along with the association between changes in ALT and AST and changes in HbA1c and body weight by treatment.
RESULTS


Baseline characteristics were balanced across treatment groups (ertugliflozin 5 mg, n = 1716; ertugliflozin 15 mg, n = 1693; non-ertugliflozin, n = 1450). At week 52 of treatment, serum levels of ALT and AST were reduced in patients in the ertugliflozin treatment groups (5 and 15 mg, respectively) compared with those in the non-ertugliflozin group. The comparator-adjusted mean (95% confidence interval [CI]) difference in change from baseline at week 52 for ALT was - 3.35 (- 4.40, - 2.31) IU/L for ertugliflozin 5 mg and - 4.08 (- 5.13, - 3.03) IU/L for ertugliflozin 15 mg; for AST, the respective values were - 1.81 (- 2.50, - 1.11) IU/L and - 2.12 (- 2.82, - 1.42) IU/L. The effects of ertugliflozin were detected across all baseline ALT and AST tertiles, with the highest tertile showing the greatest treatment differences. No meaningful differences were observed between treatment groups for FIB-4. Changes in ALT and AST showed a weak but statistically significant association with changes in HbA1c and body weight in all treatment groups.
CONCLUSIONS


Treatment with ertugliflozin resulted in a reduction in the levels of hepatic transaminases compared with the non-ertugliflozin group after 52 weeks of treatment. Changes in body weight and HbA1c contributed at least in part to the effects of ertugliflozin on liver enzymes.
TRIAL REGISTRATION


Clinicaltrials.gov registry numbers: NCT02033889, NCT01958671, NCT02036515, NCT01986855, NCT02099110, NCT02226003, NCT01999218.",2020,"At week 52 of treatment, serum levels of ALT and AST were reduced in patients in the ertugliflozin treatment groups (5 and 15 mg, respectively) compared with those in the non-ertugliflozin group.","['patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with Type 2 Diabetes']","['ertugliflozin', 'ertugliflozin (5 mg and 15\xa0mg) versus non-ertugliflozin (placebo, glimepiride, or sitagliptin', 'Ertugliflozin', 'IU/L']","['serum levels of ALT and AST', 'alanine and aspartate aminotransferase (ALT and AST, respectively) serum levels (overall and categorized into tertiles by baseline ALT and AST), Fibrosis-4 Index (FIB-4), glycated hemoglobin (HbA1c), and body weight', 'Liver Enzymes', 'levels of hepatic transaminases', 'liver enzymes', 'HbA1c and body weight', 'body weight and HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.085715,"At week 52 of treatment, serum levels of ALT and AST were reduced in patients in the ertugliflozin treatment groups (5 and 15 mg, respectively) compared with those in the non-ertugliflozin group.","[{'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Calle', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. annaswamy.raji@merck.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00867-1']
2568,32648175,Completely Minimally Invasive Esophagectomy Versus Hybrid Esophagectomy for Esophageal and Gastroesophageal Junctional Cancer: Clinical and Short-Term Oncological Outcomes.,"BACKGROUND


Minimally invasive surgery for resectable esophageal and gastroesophageal junctional (GEJ) cancer significantly reduces morbidity when compared with open surgery, as is evident from published landmark trials. Comparison of outcomes between hybrid esophagectomy (HE) and completely minimally invasive esophagectomy (CMIE) remains unclear.
OBJECTIVE


We aimed to ascertain whether CMIE is associated with less postoperative complications compared with HE without oncological compromise.
METHODS


All consecutive two-stage HEs and CMIEs performed between 2016 and 2018 were included. All procedures were performed with an intrathoracic anastomosis. Primary clinical outcomes were pulmonary infective and overall complications within 30 days of surgery, while primary oncological outcomes included overall survival (OS) and disease-free survival (DFS) at both 6 months and to date. Secondary outcomes included intraoperative variables and postoperative clinical parameters.
RESULTS


Overall, 98 patients had CMIEs and 49 patients had HEs. There were no baseline differences between the two groups. Thirty-day postoperative pulmonary infection rates were lower in the CMIE group compared with the HE group (12.2% vs. 28.6%; p = 0.014), and 30-day overall postoperative complication rates were also lower following CMIE (35.7% vs. 59.2%; p = 0.007). OS and DFS were similar between the two groups at 6 months (p = 0.201 and p = 0.109, respectively).
CONCLUSIONS


CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer. No intergroup difference was observed regarding short-term survival and cancer recurrence in patients undergoing CMIE and HE. A randomized controlled trial comparing the two operative approaches is required to validate these findings.",2020,CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer.,"['All consecutive two-stage HEs and CMIEs performed between 2016 and 2018 were included', 'Esophageal and Gastroesophageal Junctional Cancer', '98 patients had CMIEs and 49 patients had HEs']","['hybrid esophagectomy (HE) and completely minimally invasive esophagectomy (CMIE', 'CMIE', 'Minimally Invasive Esophagectomy Versus Hybrid Esophagectomy']","['short-term survival and cancer recurrence', 'OS and DFS', 'intraoperative variables and postoperative clinical parameters', 'pulmonary infective and overall complications', 'overall survival (OS) and disease-free survival (DFS', '30-day overall postoperative complication rates', 'pulmonary infective and overall postoperative complications', 'Thirty-day postoperative pulmonary infection rates']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}]",,0.286259,CMIE is associated with less pulmonary infective and overall postoperative complications compared with HE for resectable esophageal and GEJ cancer.,"[{'ForeName': 'Krashna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK. krashna@doctors.org.uk.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Abbassi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Cheuk Bong', 'Initials': 'CB', 'LastName': 'Tang', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lorenzi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Charalabopoulos', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Sritharan', 'Initials': 'S', 'LastName': 'Kadirkamanathan', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}, {'ForeName': 'Naga Venkatesh', 'Initials': 'NV', 'LastName': 'Jayanthi', 'Affiliation': 'Essex Upper GI, Regional Centre for Oesophagogastric Surgery, Broomfield Hospital, Chelmsford, UK.'}]",Annals of surgical oncology,['10.1245/s10434-020-08826-7']
2569,32648393,[Effect of long-snake moxibustion on nonspecific low back pain with symptom of cold and dampness].,"OBJECTIVE


To compare the clinical therapeutic effect of long-snake moxibustion and ginger-partitioned moxibustion at  ashi  point on nonspecific low back pain (NLBP) with symptom of cold and dampness.
METHODS


A total of 120 patients were randomized into a long-snake moxibustion group, an ashi point group and a waiting for treatment group, 40 cases in each one. Ginger-partitioned moxibustion was applied from Dazhui (GV 14) to Yaoshu (GV 2) of governor vessel in the long-snake moxibustion group, and was applied at  ashi  point of affected area in the ashi point group, 40 min each time, once every other day and totally 8 times were required. No intervention was adopted in the waiting for treatment group, and after the trial, long-snake moxibustion was applied. Before and after treatment, the visual analogue scale (VAS) scores of rest and activity, the Oswestry disability index (ODI) score and the score of cold and dampness symptom were observed in the 3 groups.
RESULTS


Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05). After treatment, the variations of the above indexes in the long-snake moxibustion group and the ashi point group were larger than those in the waiting for treatment group ( P <0.05), and the variations of the above indexes in the long-snake moxibustion group were larger than those in the ashi point group ( P <0.05).
CONCLUSION


Long-snake moxibustion can effectively improve the pain, dysfunction and the symptom of cold and dampness in patients with nonspecific low back pain, and the improvement is superior to the ginger-partitioned moxibustion at  ashi  point.",2020,"Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05).","['nonspecific low back pain with symptom of cold and dampness', 'patients with nonspecific low back pain', '120 patients']","['long-snake moxibustion and ginger-partitioned moxibustion', 'long-snake moxibustion', 'Ginger-partitioned moxibustion', 'Long-snake moxibustion']","['nonspecific low back pain (NLBP', 'visual analogue scale (VAS) scores of rest and activity, the Oswestry disability index (ODI) score and the score of cold and dampness symptom', 'pain, dysfunction and the symptom of cold and dampness', 'VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.0264507,"Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05).","[{'ForeName': 'Xiu-Wu', 'Initials': 'XW', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Li-Mei', 'Initials': 'LM', 'LastName': 'Tang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Chen-Ying', 'Initials': 'CY', 'LastName': 'Deng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Jiang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Fen-Fen', 'Initials': 'FF', 'LastName': 'Qiu', 'Affiliation': 'Second Department of Internal Medicine, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190615-k0004']
2570,32648394,[Herb-separated moxibustion on dysmenorrhea in ovarian endometriosis: a randomized controlled trial].,"OBJECTIVE


To observe the clinical therapeutic effect of herb-separated moxibustion on dysmenorrhea in ovarian endometriosis.
METHODS


A total of 54 patients with ovarian endometriosis dysmenorrhea were randomized into a herb-separated moxibustion group and a waiting-list group, 27 cases in each one (3 cases dropped off in the herb-separated moxibustion group, 4 cases dropped off in the waiting-list group). Herb-separated moxibustion was applied at hypogastrium and lumbosacral area for 30 min in the herb-separated moxibustion group, once a week for 3 months, and oral ibuprofen sustained-release capsule was given to relieve pain when necessary. Excepting giving ibuprofen sustained-release capsule when necessary, no more intervention was adopted in the waiting-list group. Before and after treatment and in 3 months follow-up, visual analogue scale (VAS) score, days of dysmenorrhea, total dose of oral painkiller were observed.
RESULTS


Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
CONCLUSION


Herb-separated moxibustion can effectively improve dysmenorrhea symptom and shorten dysmenorrhea days in patients with ovarian endometriosis.",2020,"Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
","['54 patients with ovarian endometriosis dysmenorrhea', 'patients with ovarian endometriosis', 'ovarian endometriosis']","['Herb-separated moxibustion', 'herb-separated moxibustion group and a waiting-list', 'ibuprofen', 'herb-separated moxibustion']","['visual analogue scale (VAS) score, days of dysmenorrhea, total dose of oral painkiller', 'dysmenorrhea', 'days of dysmenorrhea and the total doses of oral painkiller', 'dysmenorrhea symptom', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0156344', 'cui_str': 'Endometriosis of ovary'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",54.0,0.0324037,"Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
","[{'ForeName': 'Li-Fang', 'Initials': 'LF', 'LastName': 'Chen', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Jin', 'Affiliation': 'Yuhang Maternity and Children Healthcare Hospital of Hangzhou City.'}, {'ForeName': 'Bang-Wei', 'Initials': 'BW', 'LastName': 'Li', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Ming-Jie', 'Initials': 'MJ', 'LastName': 'Zhan', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Han-Tong', 'Initials': 'HT', 'LastName': 'Hu', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190716-k0003']
2571,32648395,[Clinical observation of herb-separated moxibustion combining western medication on allergic rhinitis of kidney- yang  deficiency type and correlation with infrared thermal imagining].,"OBJECTIVE


To observe the therapeutic effect of herb-separated moxibustion combined with budesonide nasal spray (rhinocort) on moderate to severe persistent allergic rhinitis (AR) of kidney- yang  deficiency type, and to explore the correlation between nasal temperature and condition of allergic rhinitis.
METHODS


A total of 70 patients with moderate to severe persistent AR were randomized into an observation group (35 cases) and a control group (35 cases, 3 cases dropped off). Both groups were treated with rhinocort, one spray on each side of the nostril (approximately 64 μg each spray), once in the morning and once in the evening, for 4 weeks. On the basis of the above treatment, the observation group was treated with herb-separated moxibustion at Shenshu (BL 23), Feishu (BL 13), Zhiyang (GV 9), Dazhui (GV 14), 3 moxibustions per acupoint, a single treatment lasting about 30 min. This treatment was given once every other day, 3 times every week, and totally continuous 4 weeks. The changes of AR symptom visual analogue scale (VAS) scores were observed before and after treatment and at 3 months follow-up after treatment. The heat variation (temperature, range) on projection areas of the nose, lungs, large intestine and kidneys of the two groups' patients before and after treatment were detected by the infrared thermal imaging diagnostic system, and the correlation between the VAS scores and nasal temperature before and after treatment was analyzed. The clinical effects of both groups were evaluated according to the VAS score.
RESULTS


The total effective rate in the observation group after treatment was 85.7% (30/35), which was higher than 71.9% in the control group (23/32,  P <0.05). After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05). After treatment, the nasal temperature, pulmonary range, large intestinal range and renal range of the observation group were all lower than those before treatment ( P <0.05), the nasal temperature and nasal range of the control group were lower than before treatment ( P <0.05), and the reduction of nasal temperature, nasal range and renal range in the observation group was greater than that of the control group ( P <0.05). Before and after treatment, there was a correlation between VAS score and nasal temperature ( P <0.05).
CONCLUSION


The herb-separated moxibustion combining western medication has a better effect and long-term effect than western medication alone for moderate to severe persistent AR, which can improve heat variation on projected areas of the nose, lung, large intestine and kidney of patients. In addition, nasal temperature can reflect the severity of the symptoms of patients with moderate to severe persistent AR, or it can be used as a secondary indicator to evaluate condition of AR.",2020,"After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05).","['70 patients with moderate to severe persistent AR', 'moderate to severe persistent allergic rhinitis (AR']","['herb-separated moxibustion combining western medication', 'herb-separated moxibustion at Shenshu (BL 23), Feishu (BL 13), Zhiyang (GV 9), Dazhui (GV 14), 3 moxibustions per acupoint', 'herb-separated moxibustion combined with budesonide nasal spray (rhinocort']","['nasal temperature, pulmonary range, large intestinal range and renal range', 'VAS score', 'total effective rate', 'changes of AR symptom visual analogue scale (VAS) scores', 'nasal temperature and nasal range', 'heat variation (temperature, range) on projection areas of the nose, lungs, large intestine and kidneys', 'VAS scores and nasal temperature', 'VAS score and nasal temperature', 'reduction of nasal temperature, nasal range and renal range', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",70.0,0.0139167,"After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05).","[{'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Jia', 'Affiliation': 'Department of TCM, Peking Union Medical College Hospital, Beijing 100010, China.'}, {'ForeName': 'Ji-Ping', 'Initials': 'JP', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Zhi-Hong', 'Initials': 'ZH', 'LastName': 'Wen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190613-0001']
2572,32648396,[Effect of electro-nape-acupuncture on hearing in patients with refractory flat descending idiopathic sudden sensorineural hearing loss].,"OBJECTIVE


To compare the therapeutic effect of electro-nape-acupuncture (ENA) combined with hyperbaric oxygen therapy (HBOT) and single HBOT on refractory flat descending idiopathic sudden sensorineural hearing loss (ISSNHL).
METHODS


A total of 78 patients were randomized into an ENA combined with HBOT (ENA+HBOT) group and a HBOT group, 39 cases in each one. Patients in both groups were treated with oral extract of ginkgo biloba leaves and mecobalamin tablets. On the basis of the conventional medication treatment, HBOT was adopt in the HBOT group. On the basis of the treatment in the HBOT group, electro-nape-acupuncture was applied at Fengchi (GB 20), Gongxue (Extra), Zhongzhu (TE 3), Waiguan (TE 5) and Yifeng (TE 17), Tinggong (SI 19), Tinghui (GB 2) and the vertigo-auditory area of affected side in the ENA+HBOT group. Pulse acupuncture instrument was connected at Fengchi (GB 20) and Gongxue (Extra) for 30 min (with continuous wave, 2 Hz in frequency), the needles were retained for another 30 min after electroaupuncture. The treatment was given once a day, 6 times a week for 4 weeks in both groups. Before the treatment and 2,4 weeks into the treatment, the average auditory threshold, the scores of tinnitus handicap inventory (THI) and dizziness handicap inventory (DHI) were observed, and the therapeutic effect was evaluated in both groups.
RESULTS


Compared before treatment, the average auditory threshold, the scores of THI and DHI of 2,4 weeks into the treatment were decreased in both groups ( P <0.000 1). Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1). The total effective rate was 69.2% (27/39) in the ENA+HBOT group and 51.3% (20/39) in the HBOT group, there was no statistical difference ( P >0.05).
CONCLUSION


Electro-nape- acupuncture can improve the mean auditory threshold and the symptoms of tinnitus and dizziness in patients with refractory flat descending idiopathic sudden sensorineural hearing loss.",2020,"Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1).","['patients with refractory flat descending idiopathic sudden sensorineural hearing loss', '78 patients']","['oral extract of ginkgo biloba leaves and mecobalamin tablets', 'Electro-nape- acupuncture', 'electro-nape-acupuncture', 'HBOT', 'electro-nape-acupuncture (ENA) combined with hyperbaric oxygen therapy (HBOT) and single HBOT', 'ENA combined with HBOT (ENA+HBOT']","['total effective rate', 'average auditory threshold, the scores of tinnitus handicap inventory (THI) and dizziness handicap inventory (DHI', 'mean auditory threshold and the symptoms of tinnitus and dizziness', 'therapeutic effect', 'average auditory threshold, the scores of THI and DHI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0872895', 'cui_str': 'Ginkgo Biloba Leaf Extract'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004312', 'cui_str': 'Auditory Threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",78.0,0.0201607,"Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1).","[{'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Sheng', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China; College of Acupuncture-Moxibustion and Tuina, Heilongjiang University of CM, Harbin 150036.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Bao', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Otolaryngology, First Affiliated Hospital of Heilongjiang University of CM, Harbin 150036; College of Clinical Medicine, Heilongjiang University of CM, Harbin 150036.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190614-k0002']
2573,32648474,Predictors and Clinical Outcomes of Crossover From Radial to Femoral Access During Primary Percutaneous Coronary Intervention.,"Access site complications are more common with femoral access (FA) than radial access (RA). However, due to the higher rate of failure and crossover, door-to-balloon time (DBT) is prolonged by RA. Records of 3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed. A total of 130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018. Regression analysis was performed to determine the predictors of crossover. Crossover to the femoral approach occurred in 5.9% of our cases. Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026). Female sex (odds ratio [OR]: 1.8; 95% CI, 0.99-3.46,  P  = .046) and anterior myocardial infarction (AntMI; OR: 0.52; 95% CI, 0.33-0.88,  P  = .007) were independent predictors of crossover. In-hospital mortality rates were significantly higher in the crossover group than in the radial success group (5.4% vs 1.8%,  P  = .020). Crossover to FA due to radial failure is associated with delayed DBT and increased rate of in-hospital mortality. Female sex and AntMI were primary predictors of crossover.",2020,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","['3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed', '130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018', 'Female sex (odds ratio ']",['Crossover From Radial to Femoral Access'],"['rate of in-hospital mortality', 'hospital mortality rates', 'anterior myocardial infarction', 'Mean DBT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0340293', 'cui_str': 'Myocardial Infarction, Anterior Wall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",130.0,0.0870107,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","[{'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Şahinkuş', 'Affiliation': 'Cardiology Department, Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Muhammet Necati Murat', 'Initials': 'MNM', 'LastName': 'Aksoy', 'Affiliation': 'Cardiology Department, Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Aydin', 'Affiliation': 'Cardiology Department, Vakfıkebir State Hospital, Trabzon, Turkey.'}]",Angiology,['10.1177/0003319720940128']
2574,32648476,Comparison of Web-Based and Paper Advance Directives: A Pilot Randomized Clinical Trial.,"BACKGROUND


Digital tools to document care preferences in serious illnesses are increasingly common, but their impact is unknown. We developed a web-based advance directive (AD) featuring (1) modular content eliciting detailed care preferences, (2) the ability to electronically transmit ADs to the electronic health record (EHR), and (3) use of nudges to promote document transmission and sharing.
OBJECTIVE


To compare a web-based, EHR-transmissible AD to a paper AD.
METHODS


Patients with gastrointestinal and lung malignancies were randomized to the web or paper AD. The primary outcome was the proportion of patients with newly documented advance care plans in the EHR at 8 weeks. Secondary outcomes assessed through an e-mail survey included the change in satisfaction with end-of-life plans, AD acceptability, and self-reported sharing with a surrogate.
RESULTS


Ninety-one participants were enrolled: 46 randomly allocated to the web AD and 45 to paper. Thirteen patients assigned to web AD (28%) had new documentation versus 7 (16%) assigned to paper ( P  = .14). Adjusted for demographic factors and primary diagnosis, the odds ratio of new documentation with web AD was 3.7 (95% CI: 0.8-17.0,  P  = .10). Satisfaction with advance care planning and AD acceptability were high in both groups and not significantly different. Among patients completing web ADs, 79% reported sharing plans with their caregivers, compared with 65% of those completing paper ADs ( P  = .40).
CONCLUSION


Web-based ADs hold promise for promoting documentation and sharing of preferences, but larger studies are needed to quantify effects on these intermediate end points and on patient-centered outcomes.",2020,Satisfaction with advance care planning and AD acceptability were high in both groups and not significantly different.,"['Ninety-one participants were enrolled: 46 randomly allocated to the web AD and 45 to paper', 'Patients with gastrointestinal and lung malignancies']","['web-based advance directive (AD) featuring (1) modular content eliciting detailed care preferences, (2) the ability to electronically transmit ADs to the electronic health record (EHR), and (3) use of nudges to promote document transmission and sharing']","['Satisfaction with advance care planning and AD acceptability', 'proportion of patients with newly documented advance care plans', 'change in satisfaction with end-of-life plans, AD acceptability, and self-reported sharing with a surrogate', 'odds ratio of new documentation with web AD']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",91.0,0.143038,Satisfaction with advance care planning and AD acceptability were high in both groups and not significantly different.,"[{'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rolnick', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Oredeko', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cooney-Zingman', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120940210']
2575,32648508,Postimplant Phosphodiesterase Type 5 Inhibitors Use Is Associated With Lower Rates of Thrombotic Events After Left Ventricular Assist Device Implantation.,"Background Left ventricular assist device (LVAD) thrombosis is clinically devastating and impacts the cost effectiveness of LVAD therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate LVAD thrombosis. Phosphodiesterase type 5 inhibitors (PDE-5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of PDE-5i use on thrombotic events in patients with continuous-flow LVADs. Methods and Results We obtained data from 13 772 patients with continuous flow LVADs participating in a national registry. Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis. The primary end point was a composite of LVAD thrombosis and ischemic stroke. Patients were analyzed according to any use of PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation (no PDE-5i group). The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months. The components of the primary end point (LVAD thrombosis: HR, 0.82; 95% CI, 0.74-0.90;  P <0.001; and ischemic stroke: HR, 0.85; 95% CI, 0.75-0.97;  P =0.019), as well as the secondary end point all-cause mortality (HR, 0.86; 95% CI, 0.79-0.93;  P <0.001) were lower in the PDE-5i group versus the no PDE-5i at 48 months post LVAD. The favorable results observed with postimplant PDE-5i use were consistent with both axial and centrifugal flow devices. Conclusions The postimplant use of PDE-5i was associated with fewer thrombotic events and improved survival in LVAD patients. A randomized clinical trial is warranted to confirm these findings.",2020,"The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months.","['patients with continuous-flow LVADs', 'Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis', '772 patients with continuous flow LVADs participating in a national registry', 'advanced heart failure']","['PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation', 'Phosphodiesterase type 5 inhibitors (PDE-5is', 'LVAD therapy']","['thrombotic events and improved survival', 'ischemic stroke', 'Thrombotic Events', 'composite of LVAD thrombosis and ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",13772.0,0.0719794,"The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Xanthopoulos', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tryposkiadis', 'Affiliation': 'Independent Biostatistician Athens Greece.'}, {'ForeName': 'Filippos', 'Initials': 'F', 'LastName': 'Triposkiadis', 'Affiliation': 'Department of Cardiology University General Hospital of Larissa Greece.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Fukamachi', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Soltesz', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Young', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Blackstone', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015897']
2576,32648534,Patient opinion of analgesia during external cephalic version at term in singleton pregnancy.,"To assess the opinion and the level of satisfaction of patients concerning analgesia during external cephalic version (ECV), we present the results of a survey of 120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing remifentanil and nitrous oxide. Overall, 110 (91.7%) women said they would repeat the procedure and 111 (92.5%) that they would recommend it to another pregnant woman, with no significant differences by type of analgesia. The administration and sense of comfort were rated better in the remifentanil group ( p  < .01). In conclusion, the use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women.Impact statement What is already known on this subject?  ECV is commonly a painful manoeuvre for the woman. This pain triggers maternal reactive abdominal muscle contraction and involuntary abdominal tensing, reducing the likelihood of successful version and causing some women to reject the technique. What do the results of this study add?  The use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women. The sense of comfort during ECV was also significantly better in the remifentanil group, probably because of its greater analgesic power and greater comfort during its administration. What are the implications of these findings for clinical practice and/or further research?  ECV should be carried out under analgesia, when available, not only to decrease pain but also to encourage wider adoption of the technique and enable more women to benefit from it.",2020,The administration and sense of comfort were rated better in the remifentanil group ( p  < .01).,['120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing'],"['remifentanil and nitrous oxide', 'external cephalic version (ECV', 'remifentanil', 'ECV']",['pain'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0410877', 'cui_str': 'External cephalic version'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0546024,The administration and sense of comfort were rated better in the remifentanil group ( p  < .01).,"[{'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Rodríguez', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Osuna', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Pijoan', 'Affiliation': 'Clinical Epidemiology Unit, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cobos', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Centeno', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Serna', 'Affiliation': 'Anesthesia Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'Anesthesia Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Izaskun', 'Initials': 'I', 'LastName': 'Artola', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Melchor', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Txantón', 'Initials': 'T', 'LastName': 'Martínez-Astorquiza', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Melchor', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Burgos', 'Affiliation': 'Obstetrics and Gynecology Department, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Bizkaia, Spain.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1647522']
2577,31088753,Effect of static stretching with different rest intervals on muscle stiffness.,"The aim of the study was to investigate the effect of static stretching (SS) with different rest intervals on muscle stiffness. Fifteen healthy males participated in the study. Four bouts of thirty-second SS for the gastrocnemii were performed at the maximal dorsiflexion using dynamometer with two different rest intervals between stretches, namely 0 s (R0) and 30 s (R30). Each participant underwent both stretching protocols at least 48 h apart in a random order. Between each bout of SS, the ankle was moved to 20°-plantar-flexion in 3 s, held for each rest interval time, and then returned to the stretching position in 3 s. The shear elastic modulus of the medial gastrocnemius was measured before (PRE) and immediately after (POST) four bouts of SS to assess muscle stiffness of the medial gastrocnemius. Two-way repeated measures analysis of variance (protocol × time) indicated a significant interaction effect on the shear elastic modulus. The shear elastic modulus significantly decreased after SS in both protocols [R0, PRE: 11.5 ± 3.3 kPa, POST: 10.0 ± 2.6 kPa, amount of change: 1.6 ± 0.9 kPa (13.0 ± 5.2%); R30, PRE: 11.0 ± 2.8 kPa, POST: 10.2 ± 2.1 kPa, amount of change: 0.8 ± 1.3 kPa (6.0 ± 10.4%)]. Furthermore, the SS with 0-s rest interval induced greater decrease in shear elastic modulus when compared to SS with 30-s rest interval (p = 0.023). Thus, when performing SS to decrease muscle stiffness, rest intervals between stretches should be minimized.",2019,Two-way repeated measures analysis of variance (protocol × time) indicated a significant interaction effect on the shear elastic modulus.,['Fifteen healthy males participated in the study'],"['static stretching', 'static stretching (SS']","['muscle stiffness', 'shear elastic modulus', 'shear elastic modulus of the medial gastrocnemius']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}]",15.0,0.0171017,Two-way repeated measures analysis of variance (protocol × time) indicated a significant interaction effect on the shear elastic modulus.,"[{'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan. Electronic address: nojiri.shusuke.35v@st.kyoto-u.ac.jp.'}, {'ForeName': 'Tome', 'Initials': 'T', 'LastName': 'Ikezoe', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Umehara', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan; Research Fellow of Japan Society for Promotion of Science, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Motomura', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hirono', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Ichihashi', 'Affiliation': 'Human Health Sciences, Graduate School of Medicine, Kyoto University, Japan.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.04.036']
2578,31218480,A Mixed Methods Study of Organizational Readiness for Change and Leadership During a Training Initiative Within Community Mental Health Clinics.,"This longitudinal mixed-methods study explored variation in organizational readiness for change and leadership behavior across seven organizations during a 12-month training initiative in person-centered care planning. Quantitative data was used to examine trajectories of organizational readiness for change and leadership behavior over time and qualitative data explored provider perspectives on the trajectory of these organizational factors during the 12-month training initiative. Findings indicated that levels of organizational readiness for change and leadership behavior varied across clinics, but most experienced a significant positive change at the mid-point of the training. Organizational readiness for change was positively correlated with leaderships behaviors across time. Provider focus group findings gave insight into their initial resistance to adopting the new practice and their increasing receptivity in the second 6 months due to increased understanding of the practice and leadership endorsement. Increasing provider openness to a new practice prior to training and having a consistently engaged leadership have the potential to improve the efficiency of a training initiative.",2019,Provider focus group findings gave insight into their initial resistance to adopting the new practice and their increasing receptivity in the second 6 months due to increased understanding of the practice and leadership endorsement.,['change and leadership behavior across seven organizations during a 12-month training initiative in person-centered care planning'],[],[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}]",[],[],,0.0140215,Provider focus group findings gave insight into their initial resistance to adopting the new practice and their increasing receptivity in the second 6 months due to increased understanding of the practice and leadership endorsement.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Stanhope', 'Affiliation': 'Silver School of Social Work, New York University, 1 Washington Square North, New York, NY, 10003, USA. victoria.stanhope@nyu.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'Graduate School of Social Service, Fordham University, New York, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Choy-Brown', 'Affiliation': 'Silver School of Social Work, New York University, 1 Washington Square North, New York, NY, 10003, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jessell', 'Affiliation': 'Silver School of Social Work, New York University, 1 Washington Square North, New York, NY, 10003, USA.'}]",Administration and policy in mental health,['10.1007/s10488-019-00946-x']
2579,31267573,Associations between HbA 1c  and continuous glucose monitoring-derived glycaemic variables.,"AIMS


To identify clinically useful associations between HbA 1c  levels and various continuous glucose monitoring-derived metrics.
METHODS


We retrospectively analysed end-of-study HbA 1c  levels and >2 weeks of continuous glucose monitoring data collected from 530 adults with Type 1 diabetes or insulin-requiring Type 2 diabetes during four randomized trials. Each trial lasted ≥24 weeks and provided central laboratory end-of-study HbA 1c  levels and continuous glucose monitoring data from the preceding 3 months. Participants were assigned to groups based on either HbA 1c  levels or continuous glucose monitoring-derived glucose values.
RESULTS


HbA 1c  was strongly correlated with mean glucose value (r=0.80), time spent with glucose values in the 3.9-10.0 mmol/l range (time in range; r=-0.75) and percentage of glucose values >13.9 mmol/l (r=0.72), but was weakly correlated with the percentage of glucose values <3.9 mmol/l (r=-0.39) or <3.0 mmol/l (r=-0.21). The median percentage of glucose values <3.0 mmol/l was <1.2% (<20 min/day) for all HbA 1c  -based groups, but the median percentage of values >13.9 mmol/l varied from 2.5% (0.6 h/day) to 27.8% (6.7 h/day) in the lowest and highest HbA 1c  groups, respectively. More than 90% of participants with either <2% of glucose values >13.9 mmol/l, mean glucose <7.8 mmol/l, or time in range >80% had HbA 1c  levels ≤53 mmol/mol (≤7.0%). For participants with HbA 1c  ≥64 mmol/mol (≥8.0%), the median time in range was 44%, with 90% of participants having a time in range of <59%.
CONCLUSIONS


The associations shown in the present study suggest that continuous glucose monitoring-derived metrics may help guide diabetes therapy intensification efforts in an HbA 1c  -independent manner.",2019,"HbA 1c  was strongly correlated with mean glucose value (r=0.80), time spent with glucose values in the 3.9-10.0 mmol/l range (time in range; r=-0.75) and percentage of glucose values >13.9 mmol/l (r=0.72), but was weakly correlated with the percentage of glucose values <3.9 mmol/l (r=-0.39) or <3.0 mmol/l (r=-0.21).",['530 adults with Type 1 diabetes or insulin-requiring Type 2 diabetes during four randomized trials'],['HbA 1c  levels or continuous glucose monitoring-derived glucose values'],"['percentage of glucose values', 'median time in range', 'time spent with glucose values', 'median percentage of glucose values', 'mean glucose value']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",530.0,0.014909,"HbA 1c  was strongly correlated with mean glucose value (r=0.80), time spent with glucose values in the 3.9-10.0 mmol/l range (time in range; r=-0.75) and percentage of glucose values >13.9 mmol/l (r=0.72), but was weakly correlated with the percentage of glucose values <3.9 mmol/l (r=-0.39) or <3.0 mmol/l (r=-0.21).","[{'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Welsh', 'Affiliation': 'Dexcom, Inc., San Diego, CA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Dexcom, Inc., San Diego, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Puhr', 'Affiliation': 'Dexcom, Inc., San Diego, CA, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Walker', 'Affiliation': 'Dexcom, Inc., San Diego, CA, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, CA, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14065']
2580,31604654,Impact of estimated left atrial volume on prognosis in patients with asymptomatic mild to moderate aortic valve stenosis.,"BACKGROUND


The prognostic impact of increased left atrial (LA) volume in mild-to-moderate aortic valve stenosis (AS) is unclear. We investigated the association of estimated LA volume with prognosis in a large prospective study of patients with asymptomatic mild-to-moderate AS.
METHODS


The association of estimated LA volume with major cardiovascular events (MACE, combined cardiovascular death, heart failure hospitalization and non-hemorrhagic stroke) was assessed in 1534 patients with initially mild-to moderate asymptomatic AS, participating in the Simvastatin Ezetimibe in Aortic Stenosis study for a median of 4.3 years. LA volume was estimated from LA diameter applying a validated nonlinear equation and indexed to body height in meters squared (eLAVI). An enlarged eLAVI was identified by using sex-specific cut-offs (>19 ml/height 2  in men and >17 ml/height 2  in women).
RESULTS


Patients with enlarged eLAVI were older, more obese, and had higher systolic blood pressure and left ventricular (LV) mass index (all p < 0.001). During follow-up, incident MACE occurred in 137 patients, more often in patients with enlarged eLAVI (20% vs. 7.7%, p < 0.001). Using aortic valve replacement as a competing risk event, enlarged eLAVI at baseline predicted increased hazard rate (HR) of MACE (HR 2.21 [95% confidence interval 1.37-3.55], p = 0.001) independent of significant associations with presence of LV hypertrophy, older age, higher peak aortic jet velocity, serum creatinine and lower LV ejection fraction and stroke volume.
CONCLUSIONS


Presence of enlarged eLAVI was independently associated with increased risk of MACE in patients with mild-to moderate asymptomatic AS.",2019,"The association of estimated LA volume with major cardiovascular events (MACE, combined cardiovascular death, heart failure hospitalization and non-hemorrhagic stroke) was assessed in 1534 patients with initially mild-to moderate asymptomatic AS, participating in the Simvastatin Ezetimibe in Aortic Stenosis study for a median of 4.3 years.","['in Aortic Stenosis study for a median of 4.3 years', '1534 patients with initially mild-to moderate asymptomatic AS, participating in the', 'patients with asymptomatic mild to moderate aortic valve stenosis', 'patients with mild-to moderate asymptomatic AS', 'mild-to-moderate aortic valve stenosis (AS', 'patients with asymptomatic mild-to-moderate AS']",['Simvastatin Ezetimibe'],"['enlarged eLAVI', 'hazard rate (HR) of MACE', 'LA volume', 'peak aortic jet velocity, serum creatinine and lower LV ejection fraction and stroke volume', 'systolic blood pressure and left ventricular (LV) mass index', 'risk of MACE', 'estimated LA volume with major cardiovascular events (MACE, combined cardiovascular death, heart failure hospitalization and non-hemorrhagic stroke']","[{'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}]",1534.0,0.0258749,"The association of estimated LA volume with major cardiovascular events (MACE, combined cardiovascular death, heart failure hospitalization and non-hemorrhagic stroke) was assessed in 1534 patients with initially mild-to moderate asymptomatic AS, participating in the Simvastatin Ezetimibe in Aortic Stenosis study for a median of 4.3 years.","[{'ForeName': 'Maria-Angela', 'Initials': 'MA', 'LastName': 'Losi', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University Hospital, Naples, Italy; Hypertension Research Center, University Federico II, Naples, Italy. Electronic address: losi@unina.it.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Mancusi', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University Hospital, Naples, Italy; Hypertension Research Center, University Federico II, Naples, Italy.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Midtbø', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sahrai', 'Initials': 'S', 'LastName': 'Saeed', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Simone', 'Affiliation': 'Hypertension Research Center, University Federico II, Naples, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gerdts', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.10.004']
2581,32649326,Satisfaction With Telephone Versus In-Person Interpretation Services in Limited English-Proficient Urogynecology Patients: A Randomized Controlled Trial.,"OBJECTIVE


The objective of this study was to determine if in-person interpreters improve patient satisfaction scores compared with phone interpreters for urogynecology office visits in limited English proficient (LEP) patients.
METHODS


Portuguese and Spanish LEP subjects were randomized to phone or in-person interpreter, and a 14-item questionnaire was administered with 3 subscales assessing the primary outcome of patient satisfaction with the interpreter, physician, and nursing. Subject demographics, English proficiency, overall health status, and yearly household income were recorded. Sample size calculations indicated that a mean difference of 12 in satisfaction scores could be detected with 44 subjects per arm. Analysis was conducted using descriptive statistics, and comparisons between the intervention versus control group were analyzed using Fisher exact test, Wilcoxon rank sum test, and linear regression.
RESULTS


We enrolled and randomized 106 subjects, and 82 subjects completed the study. There was a statistically significant difference in subject satisfaction between randomization groups, favoring in-person interpreters. In the as-treated analysis, the median satisfaction score for the phone interpreter group was 92.9 and 100 for in-person interpreter group (P < 0.001). Linear regression adjusted for English proficiency showed that there was a difference between median scores of 7.14 (P = 0.002).
CONCLUSIONS


Portuguese and Spanish LEP patients experienced higher satisfaction scores for urogynecology office visits when in-person interpreters are used compared with a phone interpreter. Although we found a statistically significant difference between these groups, the clinical significance of our finding is less clear. This topic should continue to be investigated for the field of urogynecology and further studies are needed.",2020,"CONCLUSIONS


Portuguese and Spanish LEP patients experienced higher satisfaction scores for urogynecology office visits when in-person interpreters are used compared with a phone interpreter.","['Limited English-Proficient Urogynecology Patients', '106 subjects, and 82 subjects completed the study', 'Portuguese and Spanish LEP subjects', 'limited English proficient (LEP) patients']",[],"['median satisfaction score', 'satisfaction scores', 'Subject demographics, English proficiency, overall health status, and yearly household income', 'patient satisfaction scores', 'subject satisfaction']","[{'cui': 'C0870816', 'cui_str': 'Limited English Proficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",106.0,0.242563,"CONCLUSIONS


Portuguese and Spanish LEP patients experienced higher satisfaction scores for urogynecology office visits when in-person interpreters are used compared with a phone interpreter.","[{'ForeName': 'Danielle Lynn', 'Initials': 'DL', 'LastName': 'Taylor', 'Affiliation': 'From the Division of Urogynecology and Reconstructive Pelvic Surgery, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Sierra', 'Affiliation': ''}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Maheshwari', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Leung', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000880']
2582,32649395,Effects of an Active Music Therapy Program on Functional Fitness in Community Older Adults.,"BACKGROUND


Health problems common among older adults living in community settings include a lack of functional fitness. Many studies have confirmed that exercises and static music therapy improve physical and psychological health problems. Exercise programs involving music have a higher frequency of attendance and motivation than other exercise programs. Active participation in active group music therapy results in better therapeutic effects.
PURPOSE


This study was designed to test the effectiveness of a 3-month active group music therapy program on the functional fitness of community older adults in Taiwan.
METHODS


A quasi-experimental design with repeated measures was applied. A convenience cluster sample of older adults was drawn from seven senior-citizen activity centers in southern Taiwan. All participants were assigned to either an experimental group (n = 77) or a comparison group (n = 69) based on the requests of each senior center. The experimental group participated in the active group music therapy program for 3 months (twice per week and 60 minutes per session). The comparison group maintained their daily activities. Each participant's level of functional fitness was measured at baseline and at 1 and 3 months after the start of the intervention.
RESULTS


Seventy-one participants in the experimental group and 62 participants in the comparison group completed the 3-month study. At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05). These significant improvements persisted through the 3-month intervention (all ps < .05).
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


Active group music therapy is an effective complementary and alternative therapy for improving six items of functional fitness in community-dwelling older adults. Healthcare professionals may incorporate this active group music therapy program as a health promotion activity for older adults living in community settings.",2020,"At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05).","['older adults was drawn from seven senior-citizen activity centers in southern Taiwan', 'Seventy-one participants in the experimental group and 62 participants in the comparison group completed the 3-month study', 'community-dwelling older adults', 'Community Older Adults', 'older adults living in community settings', 'community older adults in Taiwan']","['Active Music Therapy Program', 'active group music therapy program', 'static music therapy']","['cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance', 'level of functional fitness', 'Functional Fitness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441463', 'cui_str': 'Static'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0190018,"At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05).","[{'ForeName': 'Shu-Ya', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Chun-Fei', 'Initials': 'CF', 'LastName': 'Chen', 'Affiliation': 'BSN, RN, Research Assistant, Department of Nursing, Chung Hwa University of Medical Technology, Taiwan, ROC.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000391']
2583,32652065,"Single- versus multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized, controlled trial.","BACKGROUND


The American Academy of Blood Banks recommends single-unit red cell transfusion protocols across medicine to reduce transfusion complications and use of a scarce resource. There is minimal data regarding single-unit protocols within obstetrics.
OBJECTIVE


We aimed to compare a single- vs. multiple-unit transfusion protocol for treatment of hemodynamically stable postpartum anemia.
STUDY DESIGN


We performed a randomized trial comparing initial transfusion with 1 unit of packed red blood cells [pRBCs] (single-unit protocol) to 2 units of pRBCs (multiple-unit protocol) from 3/2018-7/2019. Postpartum women >6 hours from delivery who required transfusion were approached for consent. Unstable vital signs, hemoglobin(Hb)< 5g/dL, hemoglobinopathy, and cardiomyopathy were enrollment exclusions. Hemoglobin assessment and standardized clinical evaluation were performed 4-6 hours post-transfusion; additional pRBCs were given if indicated. The primary outcome was total units transfused. Secondary outcomes include length of stay, endometritis, wound separation/infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum. Breastfeeding, depression, maternal attachment, and fatigue scores were assessed at 4-9 weeks postpartum. 66 women were required to detect a 20% reduction in units transfused with a single-unit protocol (power=80%; α=0.05).
RESULTS


66 women were randomized (33/arm). There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb. Mean number of units transfused was lower in the single- compared to the multiple-unit protocol (1.2u vs. 2.1u, p< 0.001). Only 18.2% of women in the single-unit arm required additional pRBCs. At post-transfusion assessment, women in the single-unit arm had lower Hb (7.8g/dL vs. 8.7g/dL, p< 0.001), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
CONCLUSION


In women with hemodynamically stable postpartum anemia, a single-unit protocol avoids a second unit of pRBCs in >80% of women without significant impact on morbidity. Our work supports use of single-unit initial transfusion in this population.",2020,"There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
","['hemodynamically stable postpartum anemia', 'women with hemodynamically stable postpartum anemia', '66 women were randomized (33/arm', '66 women']","['single- vs. multiple-unit transfusion protocol', 'initial transfusion with 1 unit of packed red blood cells [pRBCs', 'Single- versus multiple-unit transfusion']","['length of stay, 30-day complications', 'length of stay, endometritis, wound separation/infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum', 'Breastfeeding, depression, maternal attachment, and fatigue scores', 'Hemoglobin assessment and standardized clinical evaluation', 'vital signs or symptoms', 'morbidity', 'additional pRBCs', 'demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb', 'total units transfused', 'Mean number of units transfused']","[{'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0156847', 'cui_str': 'Anaemia, postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449961', 'cui_str': 'Number of units'}]",66.0,0.180712,"There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
","[{'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Hamm', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA. Electronic address: Rebecca.feldmanhamm@uphs.upenn.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Perelman', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Eileen Y', 'Initials': 'EY', 'LastName': 'Wang', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Levine', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.007']
2584,32652092,A double-blind randomized trial comparing lidocaine spray and placebo spray anesthesia prior to cervical laminaria insertion.,"OBJECTIVE


To compare pain during laminaria insertion after lidocaine spray versus placebo spray anesthesia in women about to undergo a surgical abortion procedure. Study design A double blind, randomized, placebo-controlled trial of women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure. Participants received lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion. The primary outcome was participants' pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS). Secondary outcomes included scores at speculum removal and 15 minutes after speculum insertion.
RESULTS


From 7/2016 through 8/2018, we enrolled 68 and 66 women to the lidocaine and placebo groups, respectively. Baseline characteristics were similar in both groups. The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p=0.69). Reported VAS after speculum removal and 15 minutes from speculum insertion were similar in the lidocaine and placebo groups (median 2.0, p=0.99; median 1.0 vs. 1.5 respectively, p=0.32). In multivariate analyses, lidocaine use was associated with decreased VAS score at 15 minute from speculum insertion [95%CI -0.96(-1.74 - -0.18), p=0.016]. Reported VAS ≥7 at 1 st  laminaria insertion did not differ between lidocaine and placebo groups (5.88% vs. 10.61% respectively, p=0.362).
CONCLUSION


In women scheduled for laminaria insertion prior to surgical uterine evacuation at 12-24 weeks gestation, topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo. Implications Our results imply that physicians should not use topical application of lidocaine spray to the cervix before laminaria insertion to reduce women's pain. Continued efforts must be made to find means to relieve pain by using simple, effective analgesia or adjusting the technique, and not using a tenaculum whenever possible.",2020,"The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p=0.69).","['women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure', 'women about to undergo a surgical abortion procedure']","['lidocaine spray versus placebo spray anesthesia', 'lidocaine and placebo', 'lidocaine', 'lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion', 'lidocaine spray and placebo spray anesthesia', 'lidocaine spray', 'placebo']","['scores at speculum removal and 15 minutes after speculum insertion', 'pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS', 'VAS score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0227837', 'cui_str': 'Endocervical structure'}, {'cui': 'C0227829', 'cui_str': 'Exocervical structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0022980', 'cui_str': 'Laminaria'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022980', 'cui_str': 'Laminaria'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",68.0,0.786929,"The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p=0.69).","[{'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Meyer', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Dr. Pinchas Bornstein Talpiot medical leadership program, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel. Electronic address: raananmeir@gmail.com.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Cahan', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Yagel', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Afek', 'Affiliation': 'The Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Derazne', 'Affiliation': 'The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yochai', 'Initials': 'Y', 'LastName': 'Bar-Shavit', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yefet', 'Initials': 'Y', 'LastName': 'Yuval', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Shina', 'Affiliation': 'The Department of Obstetrics and Gynecology, the Chaim Sheba Medical Center, Ramat-Gan, Israel; The Dr. Pinchas Bornstein Talpiot medical leadership program, Sheba Medical Center, Tel Hashomer, Ramat-Gan, Israel.'}]",Contraception,['10.1016/j.contraception.2020.07.002']
2585,32652112,"Identifying oncogenic drivers associated with increased risk of late distant recurrence in post-menopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study.","BACKGROUND


In postmenopausal, estrogen receptor-positive, HER2-negative (ER+/HER2-) early breast cancer, the risk for distant recurrence can extend beyond 5 years of adjuvant endocrine therapy. This study aims to identify genomic driver alterations associated with late distant recurrence.
PATIENTS AND METHODS


Next generation sequencing was used to characterise driver alterations in primary tumors from a subset of 764 postmenopausal ER+/HER2- patients from the BIG 1-98 randomized trial. Late distant recurrence events were defined as ≥ 5 years from time of randomization). The association of driver alterations with distant recurrence-free interval in early and late time periods was assessed using Cox regression models. Multivariable analyses were performed to adjust for clinicopathological factors. Weighted analysis methods were used in order to correct for over-sampling of distant recurrences.
RESULTS


538 of 764 (70%) samples were successfully sequenced including 88 (63%) early and 52 (37%) late distant recurrence events after a median follow up of 8.1 years. In univariable analysis for late distant recurrence, PIK3CA mutations (58.8%) were significantly associated with reduced risk (HR 0.40, 95%CI 0.20-0.82, P=0.012), whereas amplifications on chromosome 8p11 (10.9%) (HR 4.79, 95%CI 2.30-9.97, P<0.001) and BRCA2 mutations (2.3%) (HR 5.39, 95%CI 1.51-19.29, P=0.010) were significantly associated with an increased risk. In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
CONCLUSIONS


In ER+/HER2- postmenopausal early breast cancer, PIK3CA mutations were associated with reduced risk of late distant recurrence, whereas amplifications on 8p11 and BRCA2 mutations were associated with increased risk of late distant recurrence. The characterization of oncogenic driver alterations may aid in refining treatment choices in the late disease setting, and help identify potential drug targets for testing in future trials.",2020,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
",['primary tumors from a subset of 764 postmenopausal ER+/HER2- patients from the BIG 1-98 randomized trial'],[],"['Late distant recurrence events', 'late distant recurrence events', 'risk of late distant recurrence', 'BRCA2 mutations']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}]",,0.192938,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Luen', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Savas', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kammler', 'Affiliation': 'International Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'International Breast Cancer Study Group Central Pathology Office, Department of Pathology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Biasi', 'Affiliation': 'Division of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Demanse', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hackl', 'Affiliation': 'OncogenomX Inc., Allschwil BA, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thuerlimann', 'Affiliation': 'Breast Center, Cantonal Hospital, St Gallen, Switzerland and Swiss Group for Clinical Cancer Research SAKK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'University of Milan, Milan, Italy; IEO European Institute of Oncology IRCCS, Milan Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: sherene.loi@petermac.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.024']
2586,32652133,Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study.,"Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.",2020,"24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion.","['pregnant smokers', 'Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook']","['practices alone (N\u202f=\u202f30) or best practices plus financial incentives', 'smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app', 'Smartphone-based financial incentives']","['Cigarette smoking', 'efficacy and cost-effectiveness', 'prevalence abstinence rates', 'late-antepartum']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}]",60.0,0.125537,"24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion.","[{'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Kurti', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA. Electronic address: akurti@uvm.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Hypatia A', 'Initials': 'HA', 'LastName': 'Bolivar', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Evemy', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Medina', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Skelly', 'Affiliation': 'Medical Biostatistics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Nighbor', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106201']
2587,32652432,MR enterocolonography in patients with Crohn's disease and healthy volunteers - Do we achieve diagnostic bowel distension?,"PURPOSE


The aim of our prospective randomized study was to assess diagnostic quality and stability of bowel distension in patients with Crohn's disease (CD) and healthy volunteers subjected to synchronous magnetic resonance enterography and colonography (MREC), as well as to test the role of water enema and intravenous spasmolytics. The influence of gastric content, age, gender, and body mass on bowel distension was also evaluated.
METHOD


Study groups included 164 CD patients and 53 healthy volunteers. After bowel preparation, randomized subgroups started ingestion ≥1000 mL of hyperosmolar solution within 30, 45, 60, 75, and 90 min before admission to MRI, respectively. Patients were examined in prone position and water enema was applied. Spasmolytics were administered prior to I.V. gadolinium. Distension of five bowel segments was independently assessed by two experienced radiologists.
RESULTS


MREC yields diagnostic distension of the jejunum in 81.1 % and 79.2 % patients in the CD group and controls, respectively. For the terminal ileum it was >94 % in both groups. Good and excellent distension was achieved in other bowel segments. Distension was maintained up to 75 min from the start of oral ingestion. Water enema and spasmolytics significantly and independently improved distension of the small bowel. Distension of the cecum after spasmolytics was decreased. Gastric content, age, gender and body mass had no significant influence of bowel distension.
CONCLUSIONS


MREC enables diagnostic distension of the colon and ileum (including terminal segment) in CD patients and healthy volunteers and diagnostically acceptable distension of the jejunum.",2020,"Gastric content, age, gender and body mass had no significant influence of bowel distension.
","['Study groups included 164 CD patients and 53 healthy volunteers', ""patients with Crohn's disease (CD) and healthy volunteers"", ""patients with Crohn's disease and healthy volunteers"", 'CD patients and healthy volunteers']","['ingestion ≥1000\u202fmL of hyperosmolar solution', 'gadolinium', 'synchronous magnetic resonance enterography and colonography (MREC', 'MR enterocolonography']","['diagnostic quality and stability of bowel distension', 'MREC yields diagnostic distension', 'Distension', 'Good and excellent distension', 'distension of the small bowel', 'Distension of five bowel segments', 'bowel distension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",164.0,0.0222338,"Gastric content, age, gender and body mass had no significant influence of bowel distension.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tkalčić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Matana Kaštelan', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Grubešić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mijandrušić Sinčić', 'Affiliation': 'Department of Internal Medicine, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Milić', 'Affiliation': 'Department of Internal Medicine, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miletić', 'Affiliation': 'Department of Radiology, Clinical Hospital Center of Rijeka, Rijeka, Croatia; Faculty of Medicine, University of Rijeka, Rijeka, Croatia. Electronic address: damir.miletic@medri.uniri.hr.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109100']
2588,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
2589,32652516,Protein and calorie restriction may improve outcomes in living kidney donors and kidney transplant recipients.,"Previously, we and others showed that dietary restriction protects against renal ischemia-reperfusion injury in animals. However, clinical translation of preoperative diets is scarce, and in the setting of kidney transplantation these data are lacking. In this pilot study, we investigated the effects of five days of a preoperative protein and caloric dietary restriction (PCR) diet in living kidney donors on the perioperative effects in donors, recipients and transplanted kidneys. Thirty-five kidney donors were randomized into either the PCR, 30% calorie and 80% protein reduction, or control group without restrictions. Adherence to the diet and kidney function in donors and their kidney recipients were analyzed. Perioperative kidney biopsies were taken in a selected group of transplanted kidneys for gene expression analysis. All donors adhered to the diet. From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group. PCR-donor kidney recipients showed significantly improved kidney function and lower incidence of slow graft function and acute rejection. PCR inhibited cellular immune response pathways and activated stress-resistance signaling. These observations are the first to show that preoperative dietary restriction induces postoperative recovery benefits in humans and may be beneficial in clinical settings involving ischemia-reperfusion injury.",2020,"From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group.","['living kidney donors and kidney transplant recipients', 'donors and their kidney recipients', 'Thirty-five kidney donors', 'living kidney donors', 'donors, recipients and transplanted kidneys']","['PCR, 30% calorie and 80% protein reduction, or control group without restrictions', 'Protein and calorie restriction', 'preoperative protein and caloric dietary restriction (PCR) diet']","['kidney function of donors', 'Perioperative kidney biopsies', 'kidney function and lower incidence of slow graft function and acute rejection']","[{'cui': 'C4305252', 'cui_str': 'Live donor of kidney'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",,0.0125707,"From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group.","[{'ForeName': 'Franny', 'Initials': 'F', 'LastName': 'Jongbloed', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron W F', 'Initials': 'RWF', 'LastName': 'de Bruin', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry Van', 'Initials': 'HV', 'LastName': 'Steeg', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Beekhof', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wackers', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Hesselink', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan H J', 'Initials': 'JHJ', 'LastName': 'Hoeijmakers', 'Affiliation': 'Department of Genetics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn E T', 'Initials': 'MET', 'LastName': 'Dollé', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Jan N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Aging,['10.18632/aging.103619']
2590,32652528,Secukinumab two weekly versus four weekly dosing in patients with plaque-type psoriasis: results from the randomized GAIN study.,"BACKGROUND


Secukinumab is a fully human monoclonal antibody that selectively neutralizes IL-17A and shows long lasting efficacy and safety in plaque psoriasis. More evidence is required to optimize secukinumab dosing according to clinical response.
OBJECTIVES


GAIN compared the efficacy and safety of secukinumab 300 mg every two weeks (q2w) with 300mg every 4 weeks (q4w) in patients achieving PASI75 but not PASI90 after 16 weeks.
PATIENTS AND METHODS


772 patients with moderate to severe plaque psoriasis received secukinumab 300mg s.c. at baseline, Weeks 1, 2, 3 and 4, then q4w until Week 16. At Week 16, patients with PASI≥75 to PASI<90 were randomized 1:1 to continue q4w (n=162) or switch q2w (n=163) to Week 32. Primary endpoint was superiority of q2w to q4w dosing for PASI90 response at Week 32.
RESULTS


PASI90 response at Week 32 was numerically greater with secukinumab 300mg q2w than with 300mg q4w in suboptimal responders, not reaching statistical significance (64.4% vs. 57.4%, OR0.64 95%CI[0.39, 1.07], p=0.087). Though the primary endpoint was not met, absolute PASI was significantly lower at Week 32 in q2w vs. q4w patients (2.14 vs.2.81, p=0.024). Significantly more patients with q2w vs. q4w dosing showed minimal disease activity (IGA0/1, 71.2% vs. 61.7%, p<0.05) and improved QoL (DLQI0/1, 58.9% vs. 50.5%, p<0.05) at Week 32. No new or unexpected safety signals arose.
CONCLUSIONS


Most patients achieved PASI90 response with secukinumab q4w. There was potential benefit of q2w dosing in some suboptimal responders. Continued q4w treatment can improve response even after 16 weeks.",2020,"RESULTS


PASI90 response at Week 32 was numerically greater with secukinumab 300mg q2w than with 300mg q4w in suboptimal responders, not reaching statistical significance (64.4% vs. 57.4%, OR0.64 95%CI[0.39, 1.07], p=0.087).","['patients with plaque-type psoriasis', '772 patients with moderate to severe plaque psoriasis received']","['secukinumab 300mg s.c', 'Secukinumab', 'secukinumab']","['absolute PASI', 'PASI90 response', 'minimal disease activity', 'efficacy and safety', 'superiority of q2w to q4w dosing for PASI90 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",772.0,0.0423939,"RESULTS


PASI90 response at Week 32 was numerically greater with secukinumab 300mg q2w than with 300mg q4w in suboptimal responders, not reaching statistical significance (64.4% vs. 57.4%, OR0.64 95%CI[0.39, 1.07], p=0.087).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf,and Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Körber', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germay.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sieder', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Früh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachhuber', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19398']
2591,32652544,Long-Term Efficacy of Certolizumab Pegol for the Treatment of Plaque Psoriasis: Three-Year Results from Two Randomised Phase 3 Trials (CIMPASI-1 and CIMPASI-2).,"BACKGROUND


Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic.
OBJECTIVES


Report three-year efficacy, pooled from CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) CZP in plaque psoriasis (PSO) phase 3 trials.
METHODS


Adults with moderate to severe PSO for ≥6 months were randomised 2:2:1 to CZP 200 mg, CZP 400 mg, placebo, every two weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (Weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving Week 16 PASI 50 entered an open-label CZP 400 mg Q2W escape arm (Weeks 16-144). Dose adjustments based on Psoriasis Area and Severity Index (PASI) response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90, and PGA 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology).
RESULTS


186 patients were randomised to CZP 200 mg Q2W, 175 to CZP 400 mg Q2W. At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients. Patients entering the open-label period at Week 48, from blinded treatment, received CZP 200 mg Q2W. At Week 144, PASI 75/90 was achieved by 70.6%/48.7% CZP 200 mg-randomised and 72.9%/42.7% CZP 400 mg-randomised patients. At Week 16, 72 placebo-randomised patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at Week 144.
CONCLUSIONS


Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.",2020,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","['Plaque Psoriasis', 'Adults with moderate to severe PSO for ≥6 months', '186 patients']","['CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP 200 mg Q2W', 'CZP', 'Certolizumab pegol (CZP', 'CZP 200 mg Q2W. Patients not achieving Week 16 PASI 50 entered an open-label CZP 400 mg Q2W escape', 'CZP 200 mg, CZP 400 mg, placebo']","['PASI\xa075, PASI\xa090, and PGA 0/1 responder rates', 'Psoriasis Area and Severity Index (PASI) response', 'durable efficacy']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",186.0,0.321058,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ecoffet', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Centre for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19393']
2592,32652548,Comment on: The LAPOP trial of laparoscopic or open distal pancreatectomy.,,2020,,[],['laparoscopic or open distal pancreatectomy'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]",[],,0.0272785,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}]",The British journal of surgery,['10.1002/bjs.11776']
2593,32652557,Metamizole but not Ibuprofen reduces the plasma concentration of sertraline - Implications for the concurrent treatment of pain and depression/anxiety disorders.,"AIM


Comorbidity of pain and depression or anxiety is a challenging clinical phenomenon, often requiring the concurrent application of antidepressant and analgesic drugs. Growing evidence suggests that the analgesic metamizole exhibits cytochrome P450 inducing properties. In the present study, we assessed the impact of metamizole and ibuprofen on plasma concentrations of the selective serotonin reuptake inhibitor sertraline.
METHODS


Out of a therapeutic drug monitoring (TDM) database, three groups of patients were compared: patients receiving sertraline and metamizole (n=15), patients receiving sertraline and ibuprofen (n=19) and a matched control group without one of the analgesics (n=19).
RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs. 42 ng/mL; p<0.001). In contrast, differences between the ibuprofen group and the control group did not reach statistical significance (31 vs. 42 ng/mL; p=0.128). Moreover, the metamizole group demonstrated lower dose-adjusted drug concentrations than the ibuprofen group (0.10 vs. 0.26 (ng/mL)/(mg/day); p=0.008). Finally, the metamizole group exhibited a higher proportion of patients whose sertraline concentrations were below the therapeutic reference range (40 % in the metamizole group, 5 % in the ibuprofen group, 0 % in the control group; p=0.005) indicating therapeutically insufficient drug concentrations.
CONCLUSION


Our findings support preliminary evidence that metamizole acts as a potent inductor of cytochrome P450 isoenzymes CYP2B6 and CYP3A4. We observed a clinically meaningful pharmacokinetic interaction between metamizole and sertraline, leading to insufficiently low sertraline drug concentrations. Therefore, clinicians should consider alternative drug combinations or apply TDM-guided dose adjustment of sertraline.",2020,"RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs. 42 ng/mL; p<0.001).",['n=19) and a matched control group without one of the analgesics (n=19'],"['sertraline', 'Ibuprofen', 'sertraline and ibuprofen', 'sertraline and metamizole', 'metamizole and ibuprofen', 'ibuprofen']","['lower dose-adjusted drug concentrations', 'plasma concentration', 'sertraline concentrations', 'median sertraline plasma concentrations']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.045651,"RESULTS


Metamizole was associated with 67% lower median sertraline plasma concentrations compared to the control group (14 vs. 42 ng/mL; p<0.001).","[{'ForeName': 'Arnim Johannes', 'Initials': 'AJ', 'LastName': 'Gaebler', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Schoretsanitis', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, New York.'}, {'ForeName': 'Nagia', 'Initials': 'N', 'LastName': 'Ben Omar', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Haen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Endres', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Clinical Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hiemke', 'Affiliation': 'Department of Psychiatry and Psychotherapy and Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center of Mainz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulzen', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14471']
2594,32652591,Active versus standard sun protection in patients with melanoma stage I or II: A randomised controlled feasibility trial assessing compliance with sun protection and quality of life.,"The incidence of melanoma is steadily increasing in the Western hemisphere, and one key factor is UV exposure. Sun protection is essential, particularly in patients with diagnosed melanoma. However, data on the psychological implications of sunscreen protection in melanoma patients are lacking. This project was designed as a randomised controlled feasibility trial to explore the feasibility of the diary method and tube count to assess patient compliance in the setting of a monocentric trial, furthermore to observe any recognisable trends regarding anxiety and QoL between the intervention and control group.",2020,"This project was designed as a randomised controlled feasibility trial to explore the feasibility of the diary method and tube count to assess patient compliance in the setting of a monocentric trial, furthermore to observe any recognisable trends regarding anxiety and QoL between the intervention and control group.","['patients with melanoma stage I or II', 'melanoma patients', 'patients with diagnosed melanoma']",['Active versus standard sun protection'],['sun protection and quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.117173,"This project was designed as a randomised controlled feasibility trial to explore the feasibility of the diary method and tube count to assess patient compliance in the setting of a monocentric trial, furthermore to observe any recognisable trends regarding anxiety and QoL between the intervention and control group.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Goeth', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'M-V', 'Initials': 'MV', 'LastName': 'Hegemann', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Drexler', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huppertz', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berneburg', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, DEU.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Maisch', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, DEU.'}]",The British journal of dermatology,['10.1111/bjd.19395']
2595,32652683,Long-term effectiveness of lycopene in the management of oral submucous fibrosis (OSMF): A 3 year follow-up study.,"BACKGROUND


Long-term follow-ups after receiving lycopene therapy for management of Oral Submucous Fibrosis (OSMF) are scarce. The study aimed to assess the long-term efficacy of lycopene for management of OSMF symptoms.
METHODS


In this prospective clinical study, 400 clinically diagnosed early OSMF patients were assessed for the efficacy of lycopene in alleviation of burning sensation (BS) and reduced mouth opening (MO) symptoms in comparison to placebo. After one year follow up, group A (lycopene group) was divided equally into Group A1 and Group A2. Group A1 patients were retreated with lycopene and the A2 group was followed without retreatment. After 2 years follow up, the Group A2 patients were advised retreatment but not followed as most of the patient did not agree for follow-up. However, group A1 patients were continued to follow up every 6 months for a total 3 years. Statistical analysis was by independent sample t-test and p-value less than 0.05 were considered as significant.
RESULTS


A statistically significant difference (p<0.05) in BS and MO was found between group A and B with lycopene showing better results. At one year follow up, a statistically significant recurrence in the symptoms was found (p<0.05) in lycopene group (group A). After the second intervention, there was a statistically significant difference in the improvement of symptoms between the group A1 and A2 at 6-months and one year (p<0.05) with group A1 (retreatment) showing better results.
CONCLUSIONS


Treatment with lycopene led to improvement in the symptoms of OSMF in the present study. The results highlight the importance of retreatment of lycopene for its long-term effect on alleviation the symptoms of OSMF.",2020,"At one year follow up, a statistically significant recurrence in the symptoms was found (p<0.05) in lycopene group (group A).","['400 clinically diagnosed early OSMF patients', 'oral submucous fibrosis (OSMF']","['lycopene', 'lycopene therapy', 'placebo']","['symptoms of OSMF', 'BS and MO', 'improvement of symptoms', 'alleviation of burning sensation (BS) and reduced mouth opening (MO) symptoms']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",400.0,0.025203,"At one year follow up, a statistically significant recurrence in the symptoms was found (p<0.05) in lycopene group (group A).","[{'ForeName': 'Gururaj', 'Initials': 'G', 'LastName': 'Arakeri', 'Affiliation': 'Dept of Head and Neck Oncology, HCG Cancer Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Shankargouda', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Division of Oral Pathology, Department of Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Nagaraj', 'Initials': 'N', 'LastName': 'Maddur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, ESIC Dental College and Hospital, Kalaburagi, Karnataka, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rao Us', 'Affiliation': 'Dept of Head and Neck Oncology, HCG Cancer Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Subash', 'Affiliation': 'Dept of Head and Neck Oncology, HCG Cancer Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Shekar', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Dept of Medical Oncology, HCG Cancer Hospital, Bangaluru, Karnataka, India.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Suzhou Ribo Life Science Co., Ltd, Beijing, China.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Brennan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Queen Alexandra Hospital, Portsmouth, UK.'}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.13085']
2596,32652684,"Prospective randomized trial of endoscopic vs open radial artery harvest for CABG: Clinical outcome, patient satisfaction, and midterm RA graft patency.","BACKGROUND AND AIM


Endoscopic radial artery (RA) harvest (ERAH) is an alternative to open RA harvest (ORAH) technique. Our aim was to ascertain clinical outcomes, patent satisfaction, and 1-year angiographic patency rates after ERAH and ORAH.
PATIENTS AND METHODS


A total of 50 patients undergoing coronary artery bypass grafting were prospectively randomized to two groups. In the ERAH group (25 patients) the RA was harvested endoscopically and in the ORAH group (25 patients) openly.
RESULTS


There were not differences between the groups in preoperative characteristics. Length of skin incision was shorter in ERAH (P < .001) but there were not differences in the length of RA, harvest time, blood flow, and pulsatility index after ERAH and ORAH. Wound healing was uniformly smooth in ERAH and there were two hematomas and one infection in ORAH. Postoperatively, major neuralgias were present in five patients in ORAH and none in ERAH and minor neuralgias in 11 and 3 patients (P = .02) respectively. Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001). One-year angiographic RA patency was 90% without intergroup difference. Target vessel stenosis less than 90% adversely affected RA patency (P < .0001).
CONCLUSIONS


In expert center, ERAH does not appear to have negative impact on the time harvest, the length, and quality of RA conduit, the wound healing, and the occurrence of hand and forearm complications. In addition, provides excellent cosmetic result and patient satisfaction. RA graft patency is gratifying when placed to a target coronary artery vessel with stenosis greater than 90%.",2020,Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001).,['50 patients undergoing coronary artery bypass grafting'],"['Endoscopic radial artery (RA) harvest (ERAH', 'ERAH', 'endoscopic vs open radial artery harvest for CABG']","['Wound healing', 'RA graft patency', 'length of RA, harvest time, blood flow, and pulsatility index after ERAH and ORAH', 'ERAH and minor neuralgias', 'Length of skin incision', 'time harvest, the length, and quality of RA conduit, the wound healing, and the occurrence of hand and forearm complications', 'patent satisfaction, and 1-year angiographic patency rates', 'angiographic RA patency', 'RA patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",50.0,0.0571187,Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001).,"[{'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Tamim', 'Affiliation': 'Department of Cardiac Surgery, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Alexiou', 'Affiliation': 'Department of Cardiac Surgery, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Donya', 'Initials': 'D', 'LastName': 'Al-Hassan', 'Affiliation': 'Department of Radiology, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Faraidy', 'Affiliation': 'Department of Cardiology, King Fahd Military Medical Complex, Dhahran, KSA.'}]",Journal of cardiac surgery,['10.1111/jocs.14706']
2597,32652799,High-protein diet more effectively reduces hepatic fat than low-protein diet despite lower autophagy and FGF21 levels.,"BACKGROUND AND AIMS


Non-alcoholic fatty liver disease (NAFLD) is becoming increasingly prevalent and nutrition intervention remains the most important therapeutic approach for NAFLD. Our aim was to investigate whether low- (LP) or high-protein (HP) diets are more effective in reducing liver fat and reversing NAFLD and which mechanisms are involved.
METHODS


19 participants with morbid obesity undergoing bariatric surgery were randomized into two hypocaloric (1500-1600 kcal/day) diet groups, a low protein (10E% protein) and a high protein (30E% protein), for three weeks prior to surgery. Intrahepatic lipid levels (IHL) and serum fibroblast growth factor 21 (FGF21) were measured before and after the dietary intervention. Autophagy flux, histology, mitochondrial activity, and gene expression analyses were performed in liver samples collected during surgery.
RESULTS


IHL levels decreased by 42.6% in the HP group, but were not significantly changed in the LP group despite similar weight loss. Hepatic autophagy flux and serum FGF21 increased by 66.7% and 42.2%, respectively, after 3 weeks in the LP group only. Expression levels of fat uptake and lipid biosynthesis genes were lower in the HP group compared with those in the LP group. RNA-seq analysis revealed lower activity of inflammatory pathways upon HP diet. Hepatic mitochondrial activity and expression of β-oxidation genes did not increase in the HP group.
CONCLUSIONS


HP diet more effectively reduces hepatic fat than LP diet despite of lower autophagy and FGF21. Our data suggest that liver fat reduction upon HP diets result primarily from suppression of fat uptake and lipid biosynthesis.",2020,"Hepatic autophagy flux and serum FGF21 increased by 66.7% and 42.2%, respectively, after 3 weeks in the LP group only.",['19 participants with morbid obesity undergoing bariatric surgery'],"['HP diet', 'low', 'High-protein diet', 'low protein (10E% protein) and a high protein (30E% protein', 'LP) or high-protein (HP) diets', 'hypocaloric']","['Hepatic autophagy flux and serum FGF21', 'Expression levels of fat uptake and lipid biosynthesis genes', 'IHL levels', 'Autophagy flux, histology, mitochondrial activity, and gene expression analyses', 'Hepatic mitochondrial activity and expression of β-oxidation genes', 'fat uptake and lipid biosynthesis', 'hepatic fat', 'Intrahepatic lipid levels (IHL) and serum fibroblast growth factor 21 (FGF21']","[{'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",19.0,0.0165321,"Hepatic autophagy flux and serum FGF21 increased by 66.7% and 42.2%, respectively, after 3 weeks in the LP group only.","[{'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Markova', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Seebeck', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Loft', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, 85764, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hornemann', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gantert', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kabisch', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Herz', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Loske', 'Affiliation': 'Reseach Group Molecular Nutritional Medicine, Dept. of Molecular Toxicology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ost', 'Affiliation': 'Department of Physiology of Energy Metabolism, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Coleman', 'Affiliation': 'University of Potsdam, Institute of Nutritional Science, Nuthetal, 14558, Germany.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Klauschen', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, 10117, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Rosenthal', 'Affiliation': 'Clinic for Nutritional Medicine, Berlin, 10625, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Lange', 'Affiliation': 'Centre for Obesity and Metabolic Surgery, Vivantes Hospital, Berlin, 13585, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, 85764, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Klaus', 'Affiliation': 'University of Potsdam, Institute of Nutritional Science, Nuthetal, 14558, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Grune', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, 85764, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herzig', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, 85764, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pivovarova-Ramich', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE), Nuthetal, 14558, Germany.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14596']
2598,32652833,Nicarbazin has no effect on reducing feral pigeon populations in Barcelona.,"BACKGROUND


Nicarbazin is an anti-coccidial product sometimes used as a contraceptive to reduce the size of feral pigeon populations. However, its effectiveness in reducing pigeon population size in cities has generated some controversy. Here, we evaluate its effectiveness in Barcelona city.
RESULTS


We set 23 feeding stations in which we provided nicarbazin and 10 feeding stations with a placebo (untreated corn). Censuses were carried out before and after one year of treatment, in radii of 200 m around each feeder. We additionally censused 28 circles of 200 m of radius distributed randomly 200 m away from the feeders and 28 circles distributed >500 m away from the feeders, which acted as controls. Population size across the whole city was also evaluated pre- and post-treatment. We found that feral pigeon density did not change after one year of treatment, either in the circles around feeding stations with nicarbazin or in the areas around control stations distributed at 200 and > 500 m from the feeders. Population size in placebo circles rose after a year by 10%. The pigeon census for the whole city of Barcelona showed a 10% increase.
CONCLUSION


Overall, our results indicate that the nicarbazin treatment had no effect on the feral pigeon population size, and we advise against its use as a pigeon control method, at least in large cities. This article is protected by copyright. All rights reserved.",2020,"We found that feral pigeon density did not change after one year of treatment, either in the circles around feeding stations with nicarbazin or in the areas around control stations distributed at 200 and > 500 m from the feeders.",[],"['Nicarbazin', 'nicarbazin', 'placebo (untreated corn']",[],[],"[{'cui': 'C0028004', 'cui_str': 'Nicarbazin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}]",[],,0.0679562,"We found that feral pigeon density did not change after one year of treatment, either in the circles around feeding stations with nicarbazin or in the areas around control stations distributed at 200 and > 500 m from the feeders.","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Senar', 'Affiliation': 'Museu de Ciències Naturals de Barcelona, Castell dels Tres Dragons, Parc Ciutadella, P° Picasso s/n, 08003, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Navalpotro', 'Affiliation': 'Museu de Ciències Naturals de Barcelona, Castell dels Tres Dragons, Parc Ciutadella, P° Picasso s/n, 08003, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Museu de Ciències Naturals de Barcelona, Castell dels Tres Dragons, Parc Ciutadella, P° Picasso s/n, 08003, Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Montalvo', 'Affiliation': ""Agencia de Salut Publica de Barcelona, and CIBER de Epidemiología y Salud Pública, Av.Príncep d'Astúries 63, 3r.2a, 08012, Barcelona, Spain.""}]",Pest management science,['10.1002/ps.6000']
2599,32652834,Ticagrelor monotherapy in patients undergoing percutaneous coronary intervention for bifurcation lesions.,"Ticagrelor monotherapy after a short course of aspirin is emerging as the predominant aspirin-free strategy among patients undergoing percutaneous coronary intervention. In patients included in the GLOBAL-LEADERS trial, the treatment effect of the experimental (dual antiplatelet therapy with aspirin and ticagrelor for 1 month followed by ticagrelor monotherapy) versus control strategy remained consistent irrespective of the presence or absence of coronary bifurcation. Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.",2020,Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.,"['patients undergoing percutaneous coronary intervention for bifurcation lesions', 'patients undergoing percutaneous coronary intervention', 'patients who undergo percutaneous coronary intervention of bifurcation lesions']","['Ticagrelor monotherapy', 'aspirin and ticagrelor', 'aspirin', 'ticagrelor monotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],,0.0217103,Ticagrelor monotherapy represents a safe and effective antiplatelet strategy for the treatment of patients who undergo percutaneous coronary intervention of bifurcation lesions.,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29082']
2600,32652838,True caring is protecting who is at your side.,"The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions. This technique could be routinely implemented, or selectively chosen when the risk of SB occlusion is high and a two-stent technique is not desirable. A randomized study comparing provisional stenting with the MJBT versus systematic two-stent strategy for the treatment of true bifurcation lesions is warranted.",2020,The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions.,[],"['modified jailed balloon technique (MJBT', 'provisional stenting with the MJBT']",[],[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]",[],,0.021845,The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions.,"[{'ForeName': 'Tiziana Claudia', 'Initials': 'TC', 'LastName': 'Aranzulla', 'Affiliation': 'Interventional Cardiology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Musumeci', 'Affiliation': 'Cardiology Department, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29081']
2601,32652863,Impact of interval walking training managed through smart mobile devices on albuminuria and leptin/adiponectin ratio in patients with type 2 diabetes.,"BACKGROUND


Interval walking training has demonstrated more pronounced positive effects on physical fitness and metabolism in type 2 diabetes (T2D), compared to continuous walking. One of the pathogenic mechanisms of T2D is associated with derangements in leptin/adiponectin axis, which might predispose affected individuals to vascular inflammation and albuminuria. The aim of this study was to investigate the effects of interval walking training delivered through smart mobile devices upon albuminuria and leptin/adiponectin ratio in patients with T2D.
METHODS


Patients with T2D aged 35-75 were randomized into control (n = 26) and interval training (IT, n = 14) groups. Patients in IT group had to perform three 60-min interval walking sessions (3 min intervals of slow and fast walking with the intensity of 40% and 70% of the peak energy expenditure) per week delivered by smartphone application for four months. The adherence to training was monitored remotely. Outcome measures were albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control. Leptin and adiponectin concentration was measured in serum samples by Luminex technology.
RESULTS


In the IT group compared to control group, we observed a statistically significant decrease in albuminuria (p = .002) and leptin/adiponectin ratio (p = .01), as well as a decrease in HbA1c close to statistical significance (p = .09). In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
CONCLUSION


Interval walking training is beneficial for vascular health in T2D via impact on albuminuria and leptin/adiponectin ratio.",2020,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","['patients with T2D.\nMETHODS\n\n\nPatients with T2D aged 35-75', 'patients with type 2 diabetes']","['interval walking training managed through smart mobile devices', 'smart mobile devices', 'interval walking training', 'Interval walking training']","['hip circumference', 'albuminuria and leptin/adiponectin ratio', 'Leptin and adiponectin concentration', 'albuminuria, leptin/adiponectin ratio, obesity indicators, and glycaemic control', 'leptin/adiponectin ratio', 'changes in leptin/adiponectin ratio', 'albuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",75.0,0.0424762,"In IT group, changes in leptin/adiponectin ratio correlated significantly with changes in hip circumference (p = .024).
","[{'ForeName': 'Jelizaveta', 'Initials': 'J', 'LastName': 'Sokolovska', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ostrovska', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Pahirko', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Gunita', 'Initials': 'G', 'LastName': 'Varblane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Krilatiha', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Austris', 'Initials': 'A', 'LastName': 'Cirulnieks', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Folkmane', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Valeinis', 'Affiliation': 'Faculty of Physics, Mathematics and Optometry, University of Latvia, Riga, Latvia.'}, {'ForeName': 'Aija', 'Initials': 'A', 'LastName': 'Klavina', 'Affiliation': 'Latvian Academy of Sport Education, Riga, Latvia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Selavo', 'Affiliation': 'Faculty of Computing, University of Latvia, Riga, Latvia.'}]",Physiological reports,['10.14814/phy2.14506']
2602,32645079,Cardiopulmonary bypass and internal thoracic artery: Can roller or centrifugal pumps change vascular reactivity of the graft? The IPITA study: A randomized controlled clinical trial.,"BACKGROUND


Cardiopulmonary bypass (CPB) induces a systemic inflammatory response (SIRS) and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity of the internal thoracic arteries (ITAs) due to the inflammatory response between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.
METHODS


Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). The primary endpoint was the endothelium-dependent relaxation of ITAs investigated using wire-myography. The secondary endpoint was the parietal inflammatory response of arteries defined by the measurements of superoxide levels, leukocytes and lymphocytes rate and gene expression of inflammatory proteins using. Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
RESULTS


Exposure time of ITAs to the pump flow was respectively 43.3 minutes in the RP group and 45.7 minutes in the CFP group. Acetylcholine-dependent relaxation was conserved in the two groups whatever the time. Gene expression of C3 and C4a in the artery wall decreased from Time 1 to Time 2. No oxidative stress was observed in the graft. There was no difference between the groups concerning the leukocytes and lymphocytes rate. SC5b-9 and elastase increased between Time 1 and Time 2.
CONCLUSION


Endothelium-dependent relaxation of the internal thoracic arteries was preserved during CPB whatever the type of pump used. The inflammatory response observed in the blood was not found in the graft wall within this time frame.
TRIAL REGISTRATION


Name of trial study protocol: IPITA Registration number (ClinicalTrials.gov): NCT04168853.",2020,"Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
","['patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump', 'Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under']","['internal thoracic arteries (ITAs', 'Cardiopulmonary bypass (CPB', 'Cardiopulmonary bypass and internal thoracic artery', 'CPB with a roller pump (RP group) or centrifugal pump (CFP group', 'Acetylcholine']","['leukocytes and lymphocytes rate', 'parietal inflammatory response of arteries defined by the measurements of superoxide levels, leukocytes and lymphocytes rate and gene expression of inflammatory proteins using', 'oxidative stress', 'parietal inflammatory response', 'vascular reactivity', 'Gene expression of C3 and C4a', 'SC5b-9 and elastase', 'Exposure time of ITAs to the pump flow', 'endothelium-dependent relaxation of ITAs investigated using wire-myography', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0444755', 'cui_str': 'Centrifugal pump'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}]","[{'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444755', 'cui_str': 'Centrifugal pump'}, {'cui': 'C0055162', 'cui_str': 'CFP protocol'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0523345', 'cui_str': 'Complement C4a measurement'}, {'cui': 'C0074124', 'cui_str': 'SC5b-9 protein complex'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0242599', 'cui_str': 'Neutrophil Activation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0027081', 'cui_str': 'Myography'}]",80.0,0.0607982,"Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fouquet', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dang Van', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Baudry', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Meisnerowski', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pinaud', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Binuani', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Chrétien', 'Affiliation': 'Clinical Research Department, University Hospital, Angers, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henrion', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Baufreton', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Loufrani', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}]",PloS one,['10.1371/journal.pone.0235604']
2603,32645095,The effects of static stretching programs on muscle strength and muscle architecture of the medial gastrocnemius.,"INTRODUCTION


Static stretching (SS) program are widely used in clinical and athletic settings. Many previous studies investigate the effect of SS program on muscle strength and muscle architecture (muscle thickness, and pennation angleh). However, no consensus has been reached about the effect of SS programs on muscle strength and muscle architecture. The aim of this study was to investigate the effects of 6-week SS programs performed at different weekly frequencies on muscle strength, muscle thickness and pennation angle at different ankle joint positions.
METHODS


A total of 24 healthy male volunteers were performed 6-week SS programs (2,160 s of SS: 360 s/week*6 weeks) and were randomized to a group that performed SS once a week, or a group that performed SS three times per week. Total time under stretching was equated between groups. The muscle strength (maximum voluntary isometric contraction) at three different ankle joints were assessed before and after the 6-week SS program. In addition, muscle thickness and pennation angle were assessed by ultrasonography before and after 6-week SS program.
RESULTS


There were no significant changes in all variables before and after the 6-week SS program, regardless of weekly frequency (p > 0.05).
CONCLUSIONS


Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",2020,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",['24 healthy male volunteers'],"['Static stretching (SS) program', 'static stretching programs', 'SS program', 'SS programs']","['muscle strength (maximum voluntary isometric contraction', 'Total time under stretching', 'muscle strength and muscle architecture of the medial gastrocnemius', 'muscle strength, muscle thickness and pennation angle', 'muscle strength or muscle architecture', 'muscle strength and muscle architecture (muscle thickness, and pennation angleh']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",24.0,0.0105047,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Kakeru', 'Initials': 'K', 'LastName': 'Hiraizumi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kiyono', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Taizan', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nishishita', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}]",PloS one,['10.1371/journal.pone.0235679']
2604,32645109,"A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.","BACKGROUND


Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
METHODS AND FINDINGS


A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints.
CONCLUSIONS


Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230).
TRIAL REGISTRATION


The trial is registered at ISRCTN, trial number ISRCTN30393230.",2020,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","['children aged 6-59 months', 'in Kenya and South Sudan', 'acute malnutrition in children 6-59 months (ComPAS trial', 'From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male', 'Kenya and South Sudan']","['combined protocol against standard care', 'SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF']","['cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains', 'nutritional recovery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C3273373', 'cui_str': 'South Sudan'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517590', 'cui_str': '16.7'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]",2071.0,0.180003,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lelijveld', 'Affiliation': 'No Wasted Lives, Action Against Hunger UK, London, United Kingdom.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Marron', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Onyo', 'Affiliation': 'Action Against Hunger, Juba, South Sudan.'}, {'ForeName': 'Eunice N', 'Initials': 'EN', 'LastName': 'Musyoki', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Adongo', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of International Health, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kerac', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003192']
2605,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
2606,32645164,An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.,"BACKGROUND


Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort.
METHODS


REPRIEVE enrolled PWH with low to moderate cardiovascular risk based on traditional risk factors to evaluate the effect of statin therapy on cardiovascular events. We determined baseline estimated glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations, and we evaluated baseline factors associated with eGFR <90 mL/min/1.73 m2 by logistic regression. We performed Bland-Altman plots and scatterplots to assess agreement between equations.
RESULTS


Among 7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the median body mass index (calculated as calculated as weight in kilograms divided by height in meters squared) was 25.8, and the median CD4 cell count 620/µL. The median CKD-EPI eGFR was 97 mL/min/1.73 m2, and 38% had an eGFR <90 mL/min/1.73 m2. In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate. The CKD-EPI and Modification of Diet in Renal Disease equations demonstrated strong agreement, particularly at lower eGFR values. Overall, there was 56% concordance between the 3 equations (categories <60, 60 to <90, ≥90 mL/min), improving to 73% after accounting for individual body surface area.
CONCLUSIONS


REPRIEVE enrolled a diverse cohort including a substantial number of PWH with reduced kidney function. Factors associated with reduced eGFR included traditional risk factors and tenofovir disoproxil fumarate exposure. Three commonly used equations have only fair agreement, with potential implications for both clinical care and epidemiologic studies.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","['7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the', 'Human Immunodeficiency Virus', 'persons living with human immunodeficiency virus (PWH']","['tenofovir disoproxil fumarate exposure', 'statin therapy', 'eGFR', 'tenofovir disoproxil fumarate', 'Pitavastatin']","['median CKD-EPI eGFR', 'median CD4 cell count', 'median body mass index', 'glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations', 'cardiovascular events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7770.0,0.0804019,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'HIV Treatment Clinical Research Site, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'University of Botswana and Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'Soweto Clinical Research Site, Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fiocruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Marcus V G', 'Initials': 'MVG', 'LastName': 'de Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Doutor Heitor Viera Dourado, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McComsey', 'Affiliation': 'Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa222']
2607,32645169,"Garzon R, Savona M, Baz R, et al. A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia. Blood. 2017;129(24):3165-3174.",,2020,,['acute myeloid leukemia'],['single-agent selinexor'],[],"[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3852671', 'cui_str': 'Selinexor'}]",[],,0.0224881,,[],Blood,['10.1182/blood.2020007231']
2608,32645213,Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies.,"OBJECTIVE


This post hoc analysis evaluated long-term efficacy and safety in patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies to receive long-term adjunctive perampanel.
METHODS


Patients aged 12 years and older who completed phase II or III randomized, double-blind, placebo-controlled studies could enter an OLEx study, each comprising a blinded conversion period followed by an open-label maintenance period (32-424 weeks; maximum perampanel dose = 12 mg/d). Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs) were analyzed.
RESULTS


Baseline characteristics were generally balanced between patients with FBTCS (n = 720) and GTCS (n = 138). Mean (standard deviation) cumulative duration of perampanel exposure was 102.3 (70.3) weeks (FBTCS) and 83.9 (38.4) weeks (GTCS). Retention rates were 50.0% for up to 4 years (FBTCS) and 49.2% for up to 2 years (GTCS). Across OLEx treatment durations, median reductions in seizure frequency per 28 days were 66.7% (FBTCS) and 80.6% (GTCS). Fifty percent and 75% responder and seizure-freedom rates were 59.5%, 45.3%, and 18.4%, respectively (FBTCS), and 72.5%, 51.5%, and 16.7%, respectively (GTCS). Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts. TEAE incidence was highest during Year 1 (FBTCS, 85.3%; GTCS, 86.2%); most common were dizziness and somnolence. During Year 1, serious TEAEs were reported in 81 (11.3%; FBTCS) and 10 (7.2%; GTCS) patients. TEAEs were consistent with the known safety profile of perampanel; no new safety signals were identified with long-term treatment.
SIGNIFICANCE


This post hoc analysis suggests long-term (up to 4 years) adjunctive perampanel (up to 12 mg/d) is efficacious and well tolerated in patients (aged 12 years and older) with FBTCS or GTCS.",2020,"Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts.","['patients (aged 12\xa0years and older) with FBTCS or GTCS', 'patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies', 'tonic-clonic seizures', 'Patients aged 12\xa0years and older who completed phase II or III randomized']","['GTCS', 'perampanel', 'FBTCS', 'adjunctive perampanel', 'placebo']","['efficacious and well tolerated', 'Retention rates', 'seizure frequency', 'Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs', 'seizure-freedom rates', 'Efficacy', 'Mean (standard deviation) cumulative duration of perampanel exposure', 'TEAE incidence', 'dizziness and somnolence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",720.0,0.190572,"Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rektor', 'Affiliation': 'Brno Epilepsy Center and Central European Institute of Technology (CEITEC), Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'North Tohoku Epilepsy Center, Minato Hospital, Hachinohe, Japan.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Formerly: Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Laurenza', 'Affiliation': 'Formerly: Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, Boise, Idaho, USA.'}]",Epilepsia,['10.1111/epi.16573']
2609,32645227,Effectiveness of blood flow-restricted slow walking on mobility in severe multiple sclerosis: a pilot randomized trial.,"OBJECTIVE


We tested the safety, feasibility and effectiveness of blood flow restriction-empowered low-intensity interval walking exercise (BFR-W) compared with conventional intensive overground walking (CON-W) at improving gait speed and functional capacity in patients with multiple sclerosis (MS) and severe gait disabilities.
METHODS


24 patients (58±5 years; 7 males) with progressive MS (Expanded Disability Status Scale 5.5-6.5) were randomized to receive 12 rehabilitation sessions over 6 weeks. The BFR-W group (n=12) performed interval walking (speed paced by a metronome that increased weekly) with BFR bands at the thighs. The CON-W group (n=12) received physiotherapist-assisted overground walking therapy. The primary outcome was gait speed, measured by the timed 25-foot walk test. Secondary outcomes included walking endurance, balance, strength, fatigue and quality of life. The measurements were collected at baseline, at the end of training and a 6-week follow-up.
RESULTS


The two groups did not present any baseline difference. BFR-W group safely walked without limitations due to sleeve compression, with lower increase of perceived exertion (RPE) (p<0.001) and heart rate (p=0.031) compared with the CON-W. Gait speed improved significantly in both groups (BFR-W +13%; CON-W +5%) with greater increases in the BFR-W group at end of the training (p=0.001) and at the follow-up (p=0.041). Most of the secondary outcomes significantly improved in the two groups, without between-group differences.
CONCLUSIONS


Slow interval walking with moderate BFR to the lower limbs was superior to overground walking in improving gait speed in patients with MS with a lower training load and a more durable clinical benefit.",2020,"BFR-W group safely walked without limitations due to sleeve compression, with lower increase of perceived exertion (RPE) (p<0.001) and heart rate (p=0.031) compared with the CON-W. Gait speed improved significantly in both groups (BFR-W +13%; CON-W +5%) with greater increases in the BFR-W group at end of the training (p=0.001) and at the follow-up (p=0.041).","['24 patients (58±5 years; 7 males) with progressive MS (Expanded Disability Status Scale 5.5-6.5', 'severe multiple sclerosis', 'patients with multiple sclerosis (MS) and severe gait disabilities']","['conventional intensive overground walking (CON-W', 'physiotherapist-assisted overground walking therapy', 'blood flow restriction-empowered low-intensity interval walking exercise (BFR-W', 'blood flow-restricted slow walking']","['gait speed, measured by the timed 25-foot walk test', 'gait speed', 'gait speed and functional capacity', 'walking endurance, balance, strength, fatigue and quality of life', 'heart rate', 'CON-W. Gait speed', 'perceived exertion (RPE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",24.0,0.0478559,"BFR-W group safely walked without limitations due to sleeve compression, with lower increase of perceived exertion (RPE) (p<0.001) and heart rate (p=0.031) compared with the CON-W. Gait speed improved significantly in both groups (BFR-W +13%; CON-W +5%) with greater increases in the BFR-W group at end of the training (p=0.001) and at the follow-up (p=0.041).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, Section of Sport Sciences, University of Ferrara, Via Luigi Borsari 46, 44121, Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Via Aldo Moro 8, 44124, Ferrara, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Donadi', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Via Aldo Moro 8, 44124, Ferrara, Italy.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Via Aldo Moro 8, 44124, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, Section of Sport Sciences, University of Ferrara, Via Luigi Borsari 46, 44121, Ferrara, Italy.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13764']
2610,32645234,Hemodynamics of Different Volume of Red Blood Cell Transfusion in Preterm Infant.,"BACKGROUND


Although many controversies exist regarding the risk of red blood cell (RBC) transfusions, half of preterm infants born at <32 weeks of gestational age receive RBC transfusions because of anemia of prematurity. Because of the costs and risks associated with multiple transfusions, it has been suggested that a large transfusion volume reduces the number of transfusions. However, there have been persistent concerns that RBC transfusion might lead to volume overload.
METHODS


We examined the impacts of large (20 mL/kg) compared to standard volume (15 mL/kg) transfusions on the hemodynamic variables of stable, electively transfused, preterm infants, by serially measuring echocardiographic parameters and plasma B-type natriuretic peptide (BNP) levels.
RESULTS


A total of 39 infants born at <34 weeks of gestation and aged >2 weeks at the time of enrollment were randomly allocated to either a standard volume (15 mL/kg) or a large volume (20 mL/kg) group. Significant reductions in cardiac output and transient increases in plasma BNP levels were found after RBC transfusion in both the standard and large volume (20 mL/kg) groups. However, these changes were not significantly different between the two groups.
CONCLUSIONS


Large volume transfusions could be tolerable in stable preterm infants with anemia.",2020,Significant reductions in cardiac output and transient increases in plasma BNP levels were found after RBC transfusion in both the standard and large volume (20 mL/kg) groups.,"['stable preterm infants with anemia', 'preterm infants born at <32 weeks of gestational age receive RBC transfusions because of anemia of prematurity', 'Preterm Infant', '39 infants born at <34 weeks of gestation and aged >2 weeks at the time of enrollment']",[],"['echocardiographic parameters and plasma B-type natriuretic peptide (BNP) levels', 'cardiac output', 'plasma BNP levels']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",39.0,0.0570513,Significant reductions in cardiac output and transient increases in plasma BNP levels were found after RBC transfusion in both the standard and large volume (20 mL/kg) groups.,"[{'ForeName': 'Eui Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeonghee', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gun-Ha', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung Min', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14380']
2611,32645251,"Topical odorant application of the specific olfactory receptor OR2AT4 agonist, Sandalore ®  , improves telogen effluvium-associated parameters.","OBJECTIVE


Human hair follicles (HFs) express the olfactory receptor OR2AT4, which is selectively stimulated by the synthetic sandalwood-like odorant, Sandalore ®  . In organ-cultured, human scalp HFs, Sandalore ®  prolongs anagen, and suppresses apoptosis by up-regulating intra-follicular IGF-1 mediated signalling. The objective of this study is to demonstrate whether effects of Sandalore ®  observed ex vivo translate into a clinically relevant effect in patients with telogen effluvium.
METHODS


In a randomized, double-blinded, placebo-controlled, clinical trial 60 female volunteers (18-65 years) affected by telogen effluvium received over a period of 24 weeks treatment with either 1% Sandalore ®  solution (n=30) or placebo (n=30). The study read-out parameters were the degree of hair shedding, hair volume, terminal/vellus hair ratio, anagen/catagen-telogen ratio, and patient self-assessment.
RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline. Sandalore ®  also increased the ratio of terminal/vellus hairs at week 8. Most of the anti-hair shedding effects were seen after 8 weeks and maintained at week 24. Patient questionnaire showed that verum group patients were more satisfied than the placebo group in regards to the overall results.
CONCLUSION


This clinical trial supports previous findings of anagen-prolonging effects of Sandalore ®  ex vivo with similar results now reproduced in clinical practice. It also provides evidence that a topically applied cosmetic odorant acting through HF olfactory receptors can be a therapeutic alternative to treat hair loss disorders characterized by excessive hair shedding such as telogen effluvium.",2020,"RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline.","['patients with telogen effluvium', '60 female volunteers (18-65 years) affected by telogen effluvium received over a period of 24 weeks treatment with either']","['1% Sandalore ®  solution', 'placebo']","['hair volume and the percentage of anagen HFs', 'degree of hair shedding, hair volume, terminal/vellus hair ratio, anagen/catagen-telogen ratio, and patient self-assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263518', 'cui_str': 'Telogen effluvium'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4742605', 'cui_str': 'Sandalore'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0221976', 'cui_str': 'Anagen hair'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}]",60.0,0.203102,"RESULTS


Sandalore ®  1% ameliorated clinical signs of telogen effluvium, namely it reduced hair shedding, and increased hair volume and the percentage of anagen HFs, the latter two parameters significantly more than placebo, when changes were calculated to baseline.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Jimenez', 'Affiliation': 'Mediteknia Clinic and Monasterium Clinical Hair Trial Unit, Las Palmas, Gran Canaria, Spain.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'López', 'Affiliation': 'Mediteknia Clinic and Monasterium Clinical Hair Trial Unit, Las Palmas, Gran Canaria, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bertolini', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Universidad Fernando Pessoa Canarias, Gran Canaria, Spain.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Chéret', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Westgate', 'Affiliation': 'Gill Westgate Consultancy Ltd, Stevington, Bedford, UK.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Giuliani Pharma S.p.A, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marzani', 'Affiliation': 'Giuliani Pharma S.p.A, Milan, Italy.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Paus', 'Affiliation': 'Monasterium Laboratory, Skin and Hair Research Solutions GmbH, Muenster, Germany.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13608']
2612,32645310,A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.,"PURPOSE


To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
DESIGN


Prospective, randomized, interventional study.
PARTICIPANTS


Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated.
METHODS


SETTING: Single clinical practice in an academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects were randomized to MMC delivered by preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at one day, one week, six weeks, three months, and six months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed.
MAIN OUTCOME MEASURE(S)


Proportion of subjects demonstrating IOP less than 21 mm Hg and 30% or more reduction in IOP from baseline. Secondary outcome measures included the number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
RESULTS


Participants (n=100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
CONCLUSIONS


Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.",2020,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","['Participants (n=100', 'academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects', 'Trabeculectomy', 'Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated']","['Subconjunctival Injection', 'MMC delivery (subconjunctival injection and direct scleral application', 'mitomycin C (MMC', 'Subconjunctival 5-fluorouracil injections', 'preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy', 'Mitomycin C', 'MMC']","['number of glaucoma medications', 'bleb height', 'bleb vascularity', 'bleb extension', 'number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates', 'mean IOP', 'surgical success', 'surgical outcomes and bleb morphologies']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038937', 'cui_str': 'Surgical sponge'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.153502,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","[{'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ngai', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Welsbie', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.002']
2613,32645452,Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis from a Randomized Controlled Trial.,"CONTEXT


Spokespersons serving as surrogate decision-makers for their loved ones report high levels of stress. Despite known benefits, advance care planning (ACP) conversations often do not occur. More information is needed to understand spokesperson stress during ACP.
OBJECTIVES


To: 1) explore if and how spokespersons perceive stress related to ACP conversations; 2) compare factors related to stress; and 3) assess whether ACP intervention impacted stress.
METHODS


Secondary, mixed methods analysis with data transformation of semi-structured interviews occurring during a 2x2 factorial (four armed), randomized controlled trial that compared standard online ACP to a comprehensive, online ACP decision aid. Tools were completed by patients with advanced illness (n=285) alone or with their spokesperson (n=285). 200 spokesperson interviews were purposively sampled from each of the 4 arms (50 per arm).
RESULTS


ACP conversations were reported as stressful by 54.41% (74/136), and non-stressful by 45.59% (62/136). Five themes impacting spokesperson stress were: (1) the nature of the relationship with their loved one, (2) self-described personality and belief systems, (3) knowledge and experience with illness and ACP conversations, (4) attitude toward ACP conversations, and (5) social support in caregiving and decision making. No significant differences in stress were associated with arm assignment.
CONCLUSION


Identifying what factors impact spokesperson stress in ACP conversations can be used to help design ACP interventions to more appropriately address the needs and concerns of spokespersons.",2020,"RESULTS


ACP conversations were reported as stressful by 54.41% (74/136), and non-stressful by 45.59% (62/136).","['Advance Care Planning Conversations', 'Secondary, mixed methods analysis with data transformation of semi-structured interviews occurring during a 2x2 factorial (four armed', '200 spokesperson interviews were purposively sampled from each of the 4 arms (50 per arm', 'patients with advanced illness (n=285) alone or with their spokesperson (n=285']",['standard online ACP'],"['stress', 'nature of the relationship with their loved one, (2) self-described personality and belief systems, (3) knowledge and experience with illness and ACP conversations, (4) attitude toward ACP conversations, and (5) social support in caregiving and decision making']","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.0799872,"RESULTS


ACP conversations were reported as stressful by 54.41% (74/136), and non-stressful by 45.59% (62/136).","[{'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Lipnick', 'Affiliation': 'Penn State College of Medicine. Electronic address: dlipnick@pennstatehealth.psu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Department of Humanities; Department of Medicine.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thiede', 'Affiliation': 'Penn State College of Nursing, University Park, PA, USA.'}, {'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Department of Humanities.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Lehman', 'Affiliation': 'Department of Humanities; Department of Public Health Sciences at Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; Hershey, PA, USA.'}, {'ForeName': 'Ms Rhonda', 'Initials': 'MR', 'LastName': 'Johnson', 'Affiliation': 'Department of Humanities.'}, {'ForeName': 'In Seo', 'Initials': 'IS', 'LastName': 'La', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Wiegand', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Levi', 'Affiliation': 'Department of Humanities; Department of Pediatrics.'}, {'ForeName': 'Lauren Jodi', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': 'Department of Humanities; Department of Medicine; Department of Public Health Sciences at Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; Hershey, PA, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.001']
2614,32645771,Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.,"OBJECTIVE


Nitric oxide (NO) plays several protective roles in ischemia/reperfusion (I/R) injury. Neonates undergoing the Norwood procedure are subject to develop I/R injury due to the immaturity of their organs and the potential need to interrupt or decrease systemic flow during surgery. We hypothesized that NO administration during cardiopulmonary bypass (CPB) ameliorates the I/R and could help the postoperative recovery after the Norwood procedure.
METHODS


Twenty-four neonates who underwent a Norwood procedure were enrolled in a prospective randomized blinded controlled trial to receive NO (12 patients) or placebo (12 patients) into the oxygenator of the CPB circuit during the Norwood procedure. Markers of I/R injury were collected at baseline (T0), after weaning from CPB before modified ultrafiltration (T1), after modified ultrafiltration (T2), and at 12 hours (T3) and 24 hours (T4) after surgery, and they were compared between both groups, as well as other postoperative clinical variables.
RESULTS


There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups. Troponin levels were lower in the study group at T1 (0.62 ± 58 ng/mL vs 0.87 ± 0.58 ng/mL,  P  = .31) and became significantly lower at T2 (0.36 ± 0.32 ng/mL vs 0.97 ± 0.48 ng/mL,  P  = .009).There were no significant differences between both groups for all other markers. Despite a lower troponin level, there was no difference in inotropic scores or ventricular function between both groups. Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay were not different between both groups.
CONCLUSION


Systemic administration of NO during the Norwood procedure has myocardial protective effects (lower Troponin levels) but we observed no effect on postoperative recovery. Larger sample size may be needed to show clinical differences.",2020,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.",['Twenty-four neonates who underwent a Norwood procedure'],"['Nitric Oxide Administration', 'oxygenator of the CPB circuit', 'placebo']","['Troponin levels', 'Ischemia/Reperfusion Injury', 'inotropic scores or ventricular function', 'myocardial protective effects (lower Troponin levels', 'age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time', 'Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C2242650', 'cui_str': 'Norwood procedure'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0018830', 'cui_str': 'Cardiopulmonary bypass circuit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",24.0,0.147463,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.","[{'ForeName': 'Chawki', 'Initials': 'C', 'LastName': 'Elzein', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Urbas', 'Affiliation': ""Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Hughes', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Patient-Centered Outcomes Research, Advocate Center for Pediatric Research, Research Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lefaiver', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ilbawi', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vricella', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120911034']
2615,32645813,"Corrections to ""Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small-cell lung cancer"".",,2014,,['limited-disease small-cell lung cancer'],['concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy'],[],"[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}]",[],,0.0173946,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu233']
2616,32645830,Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation.,"Background:  There is little scientific evidence regarding the effectiveness of strengthening exercises on the foot's intrinsic musculature in improving the lower limb on the statics and dynamics in healthy individuals.  Method:  To evaluate the effect on foot posture with regard to the reinforcement of the short foot exercise (SFE) compared to another without a recognized biomechanical action, which we called the ""non-biomechanical function"" (NBF) exercise. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points. An experimental group ( n  = 42) did SFE training and a control group ( n  = 43) carried out NBF exercises. The foot posture was evaluated twice via the navicular drop (ND) test, and the FPI was assessed on the day of inclusion in the study (pre-intervention) and after four weeks of training (post-intervention).  Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training. However, the foot posture was modified in both groups with respect to its initial state, and the ND value decreased.  Conclusions:  SFE could be considered a useful tool to deal with pathologies whose etiology includes excessive pronation of the foot.",2020,Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training.,"['85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points', 'healthy individuals']","['strengthening exercises', 'SFE training and a control group ( n  = 43) carried out NBF exercises', 'short foot exercise (SFE', 'SFE']",['foot posture'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0230473', 'cui_str': 'Both feet'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C1870204', 'cui_str': '(18F)1-(2-fluoroethyl)-4-((4-cyanophenoxy)methyl)piperidine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0576226', 'cui_str': 'Short foot'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",85.0,0.0321686,Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pabón-Carrasco', 'Affiliation': 'Cruz Roja, Nursing Department, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Castro-Méndez', 'Affiliation': 'Podiatry Department, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Vilar-Palomo', 'Affiliation': 'Virgen del Rocío Hospital, 41013 Seville, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jiménez-Cebrián', 'Affiliation': 'Nursing and Podiatry Department, University of Malaga, 29071 Malaga, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García-Paya', 'Affiliation': 'Nursing and Podiatry Department, University of Malaga, 29071 Malaga, Spain.'}, {'ForeName': 'Inmaculada C', 'Initials': 'IC', 'LastName': 'Palomo-Toucedo', 'Affiliation': 'Podiatry Department, University of Seville, 41009 Seville, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134882']
2617,32645831,Comparison of Two Dietary Supplements for Treatment of Uric Acid Renal Lithiasis: Citrate vs. Citrate + Theobromine.,"BACKGROUND


Uric acid (UA) renal lithiasis has a high rate of recurrence and a prevalence ranging from 10% and 15%, depending on the population. The most important etiological factor is persistence of urinary pH below 5.5 and one of the most common treatments is alkalization with citrate. Recent studies demonstrated that theobromine, which is abundant in chocolate and cocoa, is a potent inhibitor of UA crystallization.
AIM


The aim was to compare the efficacy of citrate versus citrate + theobromine as treatment for UA lithiasis.
METHODS


This randomized cross-over trial investigated the efficacy of two treatments in 47 patients with UA renal lithiasis. Urine volume, pH, UA excretion, theobromine excretion, and risk of UA crystallization (RUAC) at baseline and at the end of each intervention period were measured.
RESULTS


Each treatment significantly reduced the risk of UA crystallization compared to basal values. The RUAC after citrate + theobromine was lower than the RUAC after citrate, although this difference was not statistically significant.
CONCLUSION


The combined consumption of citrate and theobromine may be a promising strategy for the prevention of UA kidney stones.",2020,Each treatment significantly reduced the risk of UA crystallization compared to basal values.,"['Uric Acid Renal Lithiasis', '47 patients with UA renal lithiasis']","['theobromine', 'Citrate vs. Citrate + Theobromine', 'Two Dietary Supplements', 'citrate versus citrate + theobromine', 'citrate and theobromine']","['risk of UA crystallization', 'Urine volume, pH, UA excretion, theobromine excretion, and risk of UA crystallization (RUAC']","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0392525', 'cui_str': 'Nephrolithiasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039763', 'cui_str': 'Theobromine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0010423', 'cui_str': 'Crystallization'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0039763', 'cui_str': 'Theobromine'}]",47.0,0.0632672,Each treatment significantly reduced the risk of UA crystallization compared to basal values.,"[{'ForeName': 'Yumaira', 'Initials': 'Y', 'LastName': 'Hernandez', 'Affiliation': 'Urology Service of Manacor Hospital, 07500 Balearic Islands, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Costa-Bauza', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS-IdISBa), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Calvó', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS-IdISBa), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Benejam', 'Affiliation': 'Urology Service of Manacor Hospital, 07500 Balearic Islands, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Sanchis', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS-IdISBa), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Grases', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS-IdISBa), University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}]",Nutrients,['10.3390/nu12072012']
2618,32645840,Effect of a Game-Based Physical Education Program on Physical Fitness and Mental Health in Elementary School Children.,"Promotion of healthy active behaviors should start from early ages, as behaviors learned in youth are more likely to endure. A fundamental body of research in this field focuses on the implementation of programs within physical education (PE), thanks to its favorable characteristics. However, traditional PE based on exercise training and controlling styles seems to have weaker association with students' health benefits. For this reason, the aim of this study was to assess the effects of a game-based PE program on physical fitness and psychological health in schoolchildren aged 10 to 12 years old. A total of 252 students were distributed in experimental (EG, games-centered activities) and control (CG, traditional exercise training activities) groups. The program lasted 6 months. Health-related physical fitness components, psychological wellbeing, self-esteem, stress, and anxiety were assessed before and after the treatment. Both groups increased physical fitness at post-test; however, cardiorespiratory fitness did not improve. No differences were found between the groups at post-test. Our results show that games may be as effective as traditional training methods; yet, they suggest that PE alone may be insufficient for obtaining substantive benefits in cardiorespiratory fitness, regardless of the type of task presented.",2020,No differences were found between the groups at post-test.,"['Elementary School Children', 'A total of 252 students', 'schoolchildren aged 10 to 12 years old']","['exercise training', 'control (CG, traditional exercise training activities', 'Game-Based Physical Education Program', 'game-based PE program']","['Physical Fitness and Mental Health', 'physical fitness', 'Health-related physical fitness components, psychological wellbeing, self-esteem, stress, and anxiety', 'physical fitness and psychological health', 'cardiorespiratory fitness']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",252.0,0.0137873,No differences were found between the groups at post-test.,"[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Cocca', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Tirol, Austria.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Espino Verdugo', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}, {'ForeName': 'Luis Tomás', 'Initials': 'LT', 'LastName': 'Ródenas Cuenca', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Cocca', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17134883']
2619,32646282,"Effects of judo training upon body composition, autonomic function, and cardiorespiratory fitness in overweight or obese children aged 8- to 13 years.","Physical training is recommended for obese paediatric populations. We investigated the effects of recreational judo training (JT) upon body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV) in overweight or obese children. A controlled trial (RBR-9d94td) was conducted with 35 children (8-13 years) assigned into groups according to their body mass index (BMI): eutrophic (EU; n = 15; z-BMI ≤ +l and ≥ -2) and overweight or obese (OB; n = 20; z-BMI > +1 and ≤ +3). The 12-week JT included 60-min sessions performed 2 times/week at 65-75% maximal heart rate (HR). BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning were assessed. Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%). Increases (P < 0.05) occurred in lean mass (~8%), parasympathetic modulation (log HF, ~4%), VO 2peak  (~5-10%), and VO 2  (~15%), speed (~10%) and slope (~13%) at GET. Markers of cardiorespiratory fitness (relative VO 2 , slope and speed at GET) in OB approached EU after JT. In conclusion, a relatively short JT intervention to improved body composition, autonomic modulation, and physical fitness in obese children.",2020,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","['obese children', '35 children (8-13\xa0years) assigned into groups according to their', '2) and overweight or obese (OB; n =\xa020; z-BMI > +1 and ≤ +3', 'overweight or obese children aged 8- to 13 years', 'obese paediatric populations', 'overweight or obese children']","['recreational judo training (JT', 'Physical training', 'judo training', 'JT intervention', 'body mass index (BMI): eutrophic (EU; n =\xa015; z-BMI ≤ +l and ≥']","['body composition and distribution, cardiorespiratory fitness, and heart rate variability (HRV', 'BMI, waist circumference, blood pressure, HRV, peak oxygen uptake (VO 2peak ), gas exchange threshold (GET), and body fractioning', 'lean mass', 'body composition, autonomic function, and cardiorespiratory fitness', 'cardiorespiratory fitness (relative VO 2 , slope and speed at GET', 'sympathovagal balance', 'OB', 'parasympathetic modulation', 'body composition, autonomic modulation, and physical fitness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",35.0,0.0188821,"Significant reductions in OB (P < 0.05) occurred for whole body and trunk fat (~3%), trunk/limb fat-ratio (~4%), resting HR (~3%), and sympathovagal balance (log LF:HF, ~85%).","[{'ForeName': 'Iedda', 'Initials': 'I', 'LastName': 'Brasil', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Walace', 'Initials': 'W', 'LastName': 'Monteiro', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'Tainah', 'Initials': 'T', 'LastName': 'Lima', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto , Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Farinatti', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State , Rio de Janeiro, Brazil.'}]",Journal of sports sciences,['10.1080/02640414.2020.1792189']
2620,32646295,"Brief Workplace Interventions Addressing Burnout, Compassion Fatigue, and Teamwork: A Pilot Study.","Burnout and compassion fatigue are problematic for nurses, patients, and organizations. Identifying brief interventions nurses can engage in while at work to address compassion fatigue, burnout, and teamwork, as burnout and teamwork are inversely related, is important for all stakeholders. This quasi-experimental pilot study sought to examine the feasibility, acceptability, and effectiveness of five-minute interventions on nurses' burnout, compassion fatigue, and perceptions of teamwork. Nurses were randomized into five groups: meditation, journaling, gratitude, outside, and control. Participants engaged in the interventions, the majority of shifts worked, and many expressed a desire to continue after the six-week intervention period. Cohen's d effect sizes were greatest for burnout, range 0.495-0.757, and situation monitoring, range 0.252-1.1. The journaling group had the highest burnout (-11.88%), compassion satisfaction (7.54%), situation monitoring (-21.21%), and communication (-26.47%) Delta scores. Feasibility, acceptability, and effectiveness of these brief workplace interventions were preliminarily established to inform a larger study.",2020,"The journaling group had the highest burnout (-11.88%), compassion satisfaction (7.54%), situation monitoring (-21.21%), and communication (-26.47%)",[],[],"['Delta scores', 'Feasibility, acceptability, and effectiveness', 'compassion satisfaction', ""nurses' burnout, compassion fatigue, and perceptions of teamwork""]",[],[],"[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0163119,"The journaling group had the highest burnout (-11.88%), compassion satisfaction (7.54%), situation monitoring (-21.21%), and communication (-26.47%)","[{'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Copeland', 'Affiliation': 'School of Nursing, University of Northern Colorado, Greeley, Colorado, USA.'}]",Western journal of nursing research,['10.1177/0193945920938048']
2621,32646362,Metabolic benefits of probiotic combination with absorbent smectite in type 2 diabetes patients: a randomised controlled trial.,"BACKGROUND


Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. The current study aim was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy.
METHODS


A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive ""Symbiter-Smectite"" or placebo for 8-weeks administered as a sachet formulation. The primary main outcome was the change HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response.
RESULTS


Combined use of the probiotic mixture with smectite leads to a significant reduction of HOMA2-IR (3.14±0.97 vs 2.79±0.85; р=0.009) and improvement of % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of treatment period. Simultaneously in secondary outcome analysis were detected lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042). In placebo group changes were insignificant.
CONCLUSION


Probiotic with smectite due to his absorbent activity and stabilization mucus layer properties can impact on synergistic enhancement of single effect which manifested with significant reduction of IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.",2020,"In placebo group changes were insignificant.
","['type 2 diabetes patients', '55 patients met the criteria and were included in double-blind single center RCT, to receive']","['Symbiter-Smectite"" or placebo', 'probiotic combination with absorbent smectite', 'multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation', 'placebo']","['IL-8', 'IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile', 'TNF-α (p=0.008), IL-6', 'change HOMA2-IR and insulin sensitivity', 'HOMA2-IR', 'glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response', 'lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0074690', 'cui_str': 'Smectite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",55.0,0.286763,"In placebo group changes were insignificant.
","[{'ForeName': 'Nazarii', 'Initials': 'N', 'LastName': 'Kobyliak', 'Affiliation': 'Department of Endocrinology, Bogomolets National Medical University, Kyiv. Ukraine.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Abenavoli', 'Affiliation': 'Department of Health Sciences, University ""Magna Graecia"", Viale Europa - Germaneto, 88100 Catanzaro. Italy.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Falalyeyeva', 'Affiliation': 'Taras Shevchenko National University of Kyiv, Volodymyrska Str., 64/13, Kyiv, 01601. Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Kovalchuk', 'Affiliation': 'Taras Shevchenko National University of Kyiv, Volodymyrska Str., 64/13, Kyiv, 01601. Ukraine.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Kyriienko', 'Affiliation': 'Department of Endocrinology, Bogomolets National Medical University, Kyiv. Ukraine.'}, {'ForeName': 'Iuliia', 'Initials': 'I', 'LastName': 'Komisarenko', 'Affiliation': 'Department of Endocrinology, Bogomolets National Medical University, Kyiv. Ukraine.'}]",Reviews on recent clinical trials,['10.2174/1574887115666200709141131']
2622,32646369,Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients.,"BACKGROUND


Periampullary adenocarcinoma is a major clinical problem in high-risk patients including FAP population. A recent modification for visualizing the ampulla of Vater (AV) involves attaching a cap to the tip of the forward-viewing endoscope. Our aim was to compare the rates of complete visualization of AV using this cap-assisted endoscopy (CAE) approach to standard forward-viewing endoscopy (FVE). We also determined: (i) the rates of complications and additional sedation; (ii) the mean time required for duodenal examination; and (iii) the reproducibility among endoscopists performing this procedure.
METHODS


We performed esophagogastroduodenoscopy for AV visualization in 102 > 18 years old using FVE followed by CAE. Video recordings were blinded and randomly selected for independent expert endoscopic evaluation.
RESULTS


The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001). The additional doses of fentanyl, midazolam, and propofol required for CAE were 0.05, 1.9 and 36.3 mg. in 0.9, 24.5, and 77.5% patients, respectively. The mean time of duodenal examination for AV visualization was lower on CAE compared to FVE (1.41 vs. 1.95 min, p <  0.001). Scopolamine was used in 34 FVE and 24 CAE, with no association to AV complete visualization rates (p = 0.30 and p = 0.14). Three more ampullary adenomas were detected using CAE compared to FVE. Cap displacement occurred in one patient, and there was no observed adverse effect of the additional sedatives used. Kappa values for agreement between endoscopists ranged from 0.60 to 0.85.
CONCLUSIONS


CAE is feasible, reproducible and safe, with a higher success rate for complete visualization compared to FVE.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT02867826 , 16 August 2016.",2020,The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001).,"['high-risk patients', '102\u2009>\u200918\u2009years old using FVE followed by CAE', 'high-risk patients including FAP population']","['cap-assisted endoscopy (CAE) approach to standard forward-viewing endoscopy (FVE', 'fentanyl, midazolam, and propofol', 'Cap-assisted endoscopy', 'Scopolamine']","['rates of complications and additional sedation; (ii) the mean time required for duodenal examination', 'Cap displacement', 'mean time of duodenal examination for AV visualization', 'AV complete visualization rates', 'complete visualization rate for AV', 'Kappa values']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0042425', 'cui_str': 'Structure of ampulla of Vater'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.076049,The complete visualization rate for AV was higher in CAE (97.0%) compared to FVE (51.0%) (p <  0.001).,"[{'ForeName': 'Leonardo Correa', 'Initials': 'LC', 'LastName': 'Silva', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Rondinelle Martins', 'Initials': 'RM', 'LastName': 'Arruda', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Paula Fortuci Resende', 'Initials': 'PFR', 'LastName': 'Botelho', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Nogueira', 'Initials': 'LN', 'LastName': 'Taveira', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Kelly Menezio', 'Initials': 'KM', 'LastName': 'Giardina', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Biostatistics, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dias', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Cleyton Zanardo', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'Department of Biostatistics, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Fava', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Denise Peixoto', 'Initials': 'DP', 'LastName': 'Guimarães', 'Affiliation': 'Department of Endoscopy, Barretos Cancer Hospital, Antenor Duarte Villela, 1331, Zip Code: 14784 400, Barretos, São Paulo, Brazil. guimaraes.dp@gmail.com.'}]",BMC gastroenterology,['10.1186/s12876-020-01361-5']
2623,32646379,90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial.,"BACKGROUND


In the previous randomized controlled trial by our research group, we evaluated the effect of remote ischemic preconditioning (RIPC) in 130 patients (65 per arm) on acute kidney injury (AKI) within 7 days of open total aortic arch replacement. Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III). However, the long-term effect of RIPC in patients undergoing open total aortic arch replacement is unclear.
METHODS


This study was a post-hoc analysis. We aimed to assess the roles of RIPC in major adverse kidney events (MAKE), defined as consisting persistent renal dysfunction, renal replacement therapy and mortality, within 90 days after surgery in patients receiving open total aortic arch replacement.
RESULTS


In this 90-day follow-up study, data were available for all study participants. We found that RIPC failed to improve the presence of MAKE within 90 days after surgery (RIPC: 7 of 65[10.8%]) vs sham: 15 of 65[23.1%]; P = 0.061). In those patients who developed AKI after surgery, we found that the rate of MAKE within 90 days after surgery differed between the RIPC group and the sham group (RIPC: 4 of 36[11.2%]; sham: 14 of 48[29.2%]; P = 0.046).
CONCLUSIONS


At 90 days after open total aortic arch replacement, we failed to find a difference between the renoprotective effects of RIPC and sham treatment. The effectiveness or ineffectiveness of RIPC should be further investigated in a large randomized sham-controlled trial.
TRIAL REGISTRATION


This study was approved by the Ethics Committee of Fuwai Hospital (No. 2016-835) and our previous study was registered at clinicaltrials.gov before patient enrollment ( NCT03141385 ; principal investigator: G.W.; date of registration: March 5, 2017).",2020,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","['130 patients (65 per arm) on acute kidney injury (AKI) within 7\u2009days of open total aortic arch replacement', 'patients undergoing open total aortic arch replacement', 'patients receiving open total aortic arch replacement']","['remote ischemic preconditioning', 'RIPC', 'remote ischemic preconditioning (RIPC']",['postoperative AKI'],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3697092', 'cui_str': 'Aortic arch replacement'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.491524,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","[{'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China. guyanwang2006@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Congya', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xiying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guiyu', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Department of Anesthesiology, Beijng Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01085-9']
2624,32646424,Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial.,"BACKGROUND


Assessments of lung function, exacerbations and health status are common measures of chronic obstructive pulmonary disease (COPD) progression and treatment response in clinical trials. We hypothesised that a composite endpoint could more holistically assess clinically important deterioration (CID) in a COPD clinical trial setting.
METHODS


A composite endpoint was tested in a post hoc analysis of 5652 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 COPD from the 4-year UPLIFT study. Patients received tiotropium 18 μg or placebo.
RESULTS


The composite endpoint included time to first confirmed decrease in trough forced expiratory volume in 1 s (FEV 1 ) ≥100 mL, confirmed increase in St. George's Respiratory Questionnaire (SGRQ) total score ≥ 4 units, or moderate/severe exacerbation. Most patients (> 80%) experienced CID, with similar incidence among GOLD subgroups. Most confirmed trough FEV 1  (74.6-81.6%) and SGRQ (72.3-78.1%) deteriorations were sustained across the study and in all GOLD subgroups. Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6. CID was responsive to bronchodilator treatment.
CONCLUSIONS


Composite endpoints provide additional information on COPD progression and treatment effects in clinical trials.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00144339 .",2020,"Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6.",['5652 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2-4 COPD from the 4-year UPLIFT study'],['tiotropium 18\u2009μg or placebo'],"['SGRQ', ""trough forced expiratory volume in 1\u2009s (FEV 1 ) ≥100\u2009mL, confirmed increase in St. George's Respiratory Questionnaire (SGRQ) total score\u2009≥\u20094\u2009units, or moderate/severe exacerbation"", 'COPD progression', 'death', 'subsequent exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",5652.0,0.646632,"Patients with CID more frequently experienced subsequent exacerbation (hazard ratio [HR] 1.79; 95% confidence interval [CI] 1.67, 1.92) or death (HR 1.21; 95% CI 1.06, 1.39) by Month 6.","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'Member of the German Center for Lung Research (DZL), LungClinic Grosshansdorf, Wöhrendamm 80, 22927, Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Ciber de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grönke', 'Affiliation': 'Clinical Development, CSL Behring GmbH, Marburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Voß', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Internal Medicine, Weill Cornell School of Medicine, New York, NY, USA.'}]",Respiratory research,['10.1186/s12931-020-01431-y']
2625,32646428,"Daily consumption of one teaspoon of trehalose can help maintain glucose homeostasis: a double-blind, randomized controlled trial conducted in healthy volunteers.","BACKGROUND


Trehalose is a natural disaccharide that is widely distributed. A previous study has shown that daily consumption of 10 g of trehalose improves glucose tolerance in individuals with signs of metabolic syndrome. In the present study, we determined whether a lower dose (3.3 g/day) of trehalose improves glucose tolerance in healthy Japanese volunteers.
METHODS


This was a randomized, double-blind, placebo-controlled study of healthy Japanese participants (n = 50). Each consumed 3.3 g of trehalose (n = 25) or sucrose (n = 25) daily for 78 days. Their body compositions were assessed following 0, 4, 8, and 12 weeks; and serum biochemical parameters were assayed and oral 75-g glucose tolerance tests were performed at baseline and after 12 weeks.
RESULTS


There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups. However, whereas after 12 weeks of sucrose consumption, the plasma glucose concentration 2 h after a 75-g glucose load was significantly higher than the fasting concentration, after 12 weeks of trehalose consumption the fasting and 2-h plasma glucose concentrations were similar. Furthermore, an analysis of the participants with relatively high postprandial blood glucose showed that the plasma glucose concentration 2 h after a 75-g glucose load was significantly lower in the trehalose group than in the sucrose group.
CONCLUSIONS


Our findings suggest that trehalose helps lower postprandial blood glucose in healthy humans with higher postprandial glucose levels within the normal range, and may therefore contribute to the prevention of pathologies that are predisposed to by postprandial hyperglycemia,, even if the daily intake of trehalose is only 3.3 g, an amount that is easily incorporated into a meal.
TRIAL REGISTRATION


UMIN, UMIN000033536 . Registered 27 July 2018.",2020,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","['healthy Japanese participants (n\u2009=\u200950', 'healthy humans', 'healthy volunteers', 'individuals with signs of metabolic syndrome', 'healthy Japanese volunteers']","['trehalose', 'trehalose (n\u2009=\u200925) or sucrose', 'placebo']","['glucose tolerance', 'postprandial blood glucose', 'serum biochemical parameters', 'plasma glucose concentration', 'fasting and 2-h plasma glucose concentrations', 'body composition and serum biochemistry']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",,0.132141,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","[{'ForeName': 'Chiyo', 'Initials': 'C', 'LastName': 'Yoshizane', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan. chiyo.yoshizane@hb.nagase.co.jp.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Mizote', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Norie', 'Initials': 'N', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Mitsuzumi', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Ushio', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}]",Nutrition journal,['10.1186/s12937-020-00586-0']
2626,32646502,Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial.,"OBJECTIVES


The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria.
TRIAL DESIGN


Randomized clinical trial, controlled, open, parallel group, to evaluate the effectiveness of steroids in adult patients with confirmed COVID-19, with incipient pulmonary involvement, without hospital admission criteria. Patients will be stratified by the presence or not of radiological data on pneumonia.
PARTICIPANTS


We will include patients with early stage SARS-Cov-2 pneumonia who do not meet hospital admission criteria from the reference hospital, the Hospital Universitario de Burgos, in the region of Castilla y León, Spain. Patients will be followed-up by specialist physicians and Primary Health Care professionals.
INCLUSION CRITERIA


- Men and women. - Age between 18 and 75 years old. - Diagnosed SARS-CoV-2 infection, by PCR and/or IgM+ antibody test and/or antigen test. - Clinical diagnosis of lung involvement: (respiratory symptoms +/- pathological auscultation +/- O2 desaturation) - Chest X-ray with mild-moderate alterations or normal. - Patients who give their verbal informed consent in front of witnesses, which will be reflected in the patients' medical records.
EXCLUSION CRITERIA


- Oxygen desaturation below 93% or P0 2  < 62. - Moderate-severe dyspnea or significant respiratory or general deterioration that makes admission advisable. - Chest X-ray with multifocal infiltrates. - Insulin-dependent diabetes with poor control or glycaemia in the emergency room test greater than 300 mg/ml (fasting or not). - Other significant comorbidities: Severe renal failure (creatinine clearance < 30 mL/min); cirrhosis or chronic liver disease, poorly controlled hypertension. - Heart rhythm disturbances (including prolonged QT). - Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents); cancer. - Pregnant or breast-feeding women. - Patients under use of glucocorticoids for other diseases. - History of allergy or intolerance to any of the drugs in the study (prednisone, azithromycin or hydroxychloroquine). - Patients who took one or more of the study drugs in the 7 days prior to study inclusion. - Patients taking non-suppressible drugs with risk of QT prolongation or significant interactions. - Patients unwilling or unable to participate until study completion. - Participation in another study.
INTERVENTION AND COMPARATOR


Eligible patients will be randomized to receive standard outpatient treatment only (group 1) or standard outpatient treatment plus prednisone (group 2). - Group 1: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days. - Group 2: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days + prednisone 60 mg / 24 h for 3 days, 30 mg / 24 h for 3 days and 15 mg / 24 h for 3 days.
MAIN OUTCOMES


If the patient requires ambulatory observation, according to the protocol established in this respect in the Emergency Department, meets all the criteria for inclusion and none for exclusion, data will be taken by the person responsible on the data collection sheet. The main result is admission after 30 days. Secondary outcomes are 30-day ICU admission and hospital stay. The safety variable will be the occurrence of clinical symptoms or delirium related to the steroids. Also, the possible decompensations of diabetes will be measured. All tests will be on an intention-to-treat basis.
RANDOMISATION


Treatment will be assigned according to stratified randomization by the presence or absence of radiological data of lung involvement (previously performed by random sequence 1:1 generated with Epidat and kept hidden by opaque, sealed envelopes, which will only be opened after inclusion and basal measurement).
BLINDING (MASKING)


Participants, caregivers and personnel responsible for outcomes measurement will not be blinded to group assignment, once the patient is included and the basal measurement performed, as per protocol design.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The percentage of patients with incipient lung involvement is unknown, but given that pulmonary involvement already exists it is estimated to be around 20%. We consider that the intervention could reduce this percentage to 5%, so the necessary sample size would be 200 subjects (100 per group), with a power of 80% and an estimated loss percentage of 10%.
TRIAL STATUS


The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee. The trial is in the recruitment phase. Recruitment began 19 April, 2020 and is anticipated to be complete by April 2021.
TRIAL REGISTRATION


The trial was registered under the title ""OUTPATIENT TREATMENT OF EARLY PULMONARY COVID19 WITH CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE"" with EudraCT number 2020-001622-64 , registered on 3 April 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee.","[' with EudraCT number 2020-001622-64 , registered on 3 April 2020', 'adult patients with confirmed COVID-19, with incipient pulmonary involvement, without hospital admission criteria', ' Pregnant or breast-feeding women', 'early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria', ' Age between 18 and 75 years old', ' Men and women', ' Patients who took one or more of the study drugs in the 7 days prior to study inclusion', ' 30 mL/min); cirrhosis or chronic liver disease, poorly controlled hypertension', 'patients with early stage SARS-Cov-2 pneumonia who do not meet hospital admission criteria from the reference hospital, the Hospital Universitario de Burgos, in the region of Castilla y León, Spain', 'Patients will be followed-up by specialist physicians and Primary Health Care professionals', ' Patients unwilling or unable to participate until study completion']","['azithromycin 500 mg/24h for 5 days + prednisone', 'standard outpatient treatment only (group 1) or standard outpatient treatment plus prednisone', 'paracetamol 1 g/8 h (on demand) + hydroxychloroquine', 'prednisone, azithromycin or hydroxychloroquine', 'COVID-19 with steroids', 'steroids', 'glucocorticoids', 'oral corticosteroids (prednisone', 'azithromycin']","[' Heart rhythm disturbances', '30-day ICU admission and hospital stay', 'renal failure (creatinine clearance', 'pathological auscultation ']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205256', 'cui_str': 'Incipient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",,0.132014,"The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Saiz-Rodríguez', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Peña', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Lázaro', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'González', 'Affiliation': 'Gerencia de Atención Primaria de Burgos, Burgos, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martínez', 'Affiliation': 'Gerencia de Atención Primaria de Burgos, Burgos, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Cordero', 'Affiliation': 'Instituto de Investigación Sanitaria Bioaraba, Vitoria-Gasteiz, Álava, Spain.'}, {'ForeName': 'Juan T', 'Initials': 'JT', 'LastName': 'Vicente', 'Affiliation': 'Emergency Department, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Emergency Department, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Coma', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'de Frutos', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Labrador', 'Affiliation': 'Research Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pueyo', 'Affiliation': 'Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain. pueyo@saludcastillayleon.es.'}]",Trials,['10.1186/s13063-020-04575-w']
2627,32646526,A mother-child intervention program for adolescent mothers: Results from a randomized controlled trial (the TeeMo study).,"Children of adolescent mothers are a high-risk group for negative child development. Previous findings suggest that early interventions may enhance child development by improving mother-child interaction. The purpose of the current study was to evaluate a mother-child intervention (STEEP-b) program in high-risk adolescent mother-infant dyads (N = 56) within a randomized controlled trial (RCT). Mother-child interaction was assessed at baseline (T1), postintervention (T2), and follow-up (T3). The primary outcome was the change in maternal sensitivity and child responsiveness from T1 to T2 that was measured by blinded ratings of videotaped mother-child-interaction with the Emotional Availability Scales. A modified intention-to-treat analysis was performed to examine the data. No intervention effect was found for maternal sensitivity, 95% CI [-0.59-0.60], p = .99, and child responsiveness, 95% CI [-0.51-0.62], p = .84. Maternal sensitivity and child responsiveness did not change over time in both groups (all ps > .05). A statistically nonsignificant, but potentially clinically meaningful difference emerged between rates of serious adverse events, SC: 4 (14.8%), STEEP-b: 1 (3.4%), possibly driven by different intensity of surveillance of dyads in the treatment groups. The current findings question the effectiveness of STEEP-b for high-risk adolescent mothers and do not justify the broad implementation of this approach.",2020,"No intervention effect was found for maternal sensitivity, 95% CI [-0.59-0.60], p = .99, and child responsiveness, 95% CI [-0.51-0.62], p = .84.","['high-risk adolescent mothers', 'high-risk adolescent mother-infant dyads (N = 56', 'adolescent mothers', 'Children of adolescent mothers']",['mother-child intervention (STEEP-b) program'],"['Mother-child interaction', 'rates of serious adverse events', 'change in maternal sensitivity and child responsiveness from T1 to T2 that was measured by blinded ratings of videotaped mother-child-interaction with the Emotional Availability Scales', 'Maternal sensitivity and child responsiveness', 'maternal sensitivity']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.131158,"No intervention effect was found for maternal sensitivity, 95% CI [-0.59-0.60], p = .99, and child responsiveness, 95% CI [-0.51-0.62], p = .84.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Firk', 'Affiliation': 'Child Neuropsychology Section, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dahmen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dempfle', 'Affiliation': 'Institute of Medical Informatics and Statistics, Kiel University, Kiel, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Niessen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Baumann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Reinhild', 'Initials': 'R', 'LastName': 'Schwarte', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Koslowski', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kelberlau', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Konrad', 'Affiliation': 'Child Neuropsychology Section, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Herpertz-Dahlmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}]",Development and psychopathology,['10.1017/S0954579420000280']
2628,32646532,Goal-setting program improves nutrition and physical activity among Supplemental Nutrition Assistance Program eligible adults.,"OBJECTIVE


To examine the impact of Nutrition for Life (NFL), a goal-setting nutrition education program, on the knowledge, self-efficacy and behaviour of adults eligible for Supplemental Nutrition Assistance Program-Education.
DESIGN


NFL was developed using a 4-week goal-setting behavioural strategy focused on nutrition, physical activity and meal planning techniques. A quantitative repeated-measures design using self-reported data was collected at pre- and post-interventions and at 1-week and 1-month follow-ups.
SETTING


Two Federally Qualified Health Centers in Philadelphia, PA, USA.
PARTICIPANTS


A total of ninety-eight participants enrolled in the intervention; the majority were women (80·2 %), Black/Non-Hispanic (75·0 %) and 45-54 year old (39·6 %).
RESULTS


Participants showed significant improvement in knowledge, self-efficacy and behaviour. Specifically, mean daily intake for vegetables increased by 0·31 cup (P < 0·05) and for fruits by 0·39 cup (P < 0·01) at 1-week follow-up. Participants also showed healthier behaviour at 1-month follow-up. Planning at least seven meals per week increased from 14·8 to 50 % (P < 0·01), completing at least 30 min of physical activity every day in the last week increased from 16·7 to 36 % (P < 0·01) and consuming water with all meals increased from 39 to 70·6 % (P < 0·01).
CONCLUSIONS


The implementation of a goal-oriented nutrition education program offers a promising approach at achieving positive behaviour change among SNAP-eligible adults.",2020,"Specifically, mean daily intake for vegetables increased by 0·31 cup (P < 0·05) and for fruits by 0·39 cup (P < 0·01) at 1-week follow-up.","['Two Federally Qualified Health Centers in Philadelphia, PA, USA', 'A total of ninety-eight participants enrolled in the intervention; the majority were women (80·2 %), Black/Non-Hispanic (75·0 %) and 45-54 year old (39·6 ', 'Supplemental Nutrition Assistance Program eligible adults', 'adults eligible for Supplemental Nutrition Assistance Program-Education', 'SNAP-eligible adults']",['Nutrition for Life (NFL'],"['nutrition and physical activity', 'mean daily intake for vegetables', 'knowledge, self-efficacy and behaviour', 'healthier behaviour']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1177045', 'cui_str': 'Snap'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",98.0,0.0361509,"Specifically, mean daily intake for vegetables increased by 0·31 cup (P < 0·05) and for fruits by 0·39 cup (P < 0·01) at 1-week follow-up.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Karamanian', 'Affiliation': 'Health Promotion Council, Public Health Management Corporation, Philadelphia, PA19102, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zepka', 'Affiliation': 'Public Health Management Corporation, Philadelphia, PA19102, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ernst', 'Affiliation': 'Public Health Management Corporation, Philadelphia, PA19102, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'West', 'Affiliation': 'Public Health Management Corporation, Philadelphia, PA19102, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grode', 'Affiliation': 'Public Health Management Corporation, Philadelphia, PA19102, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Health Promotion Council, Public Health Management Corporation, Philadelphia, PA19102, USA.'}]",Public health nutrition,['10.1017/S1368980019004518']
2629,32646559,"Re. Guber et al: How to Prevent Retinal Shift after Rhegmatogenous Retinal Detachment Repair: A Prospective, Randomized Study.",,2020,,['after Rhegmatogenous Retinal Detachment Repair'],['Retinal Shift'],[],"[{'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0234217,,"[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Casswell', 'Affiliation': 'Vitreoretinal Department, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Charteris', 'Affiliation': 'Vitreoretinal Department, Moorfields Eye Hospital, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.01.020']
2630,32646561,Efficacy and Safety of Alirocumab in Adults With Homozygous Familial Hypercholesterolemia: The ODYSSEY HoFH Trial.,"BACKGROUND


Homozygous familial hypercholesterolemia (HoFH) is characterized by extremely elevated low-density lipoprotein-cholesterol (LDL-C) levels and early onset atherosclerotic cardiovascular disease despite treatment with conventional lipid-lowering treatment.
OBJECTIVES


This study was designed to assess LDL-C reduction with the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in adult patients with HoFH.
METHODS


This randomized, double-blind, placebo-controlled, parallel-group, phase 3 study evaluated efficacy and safety of alirocumab 150 mg every 2 weeks. The primary endpoint was percent reduction from baseline in LDL-C versus placebo after 12 weeks of treatment.
RESULTS


Patients (N = 69) were randomized 2:1 to alirocumab or placebo. At baseline, background lipid-lowering treatment included 67 patients receiving statin (59 patients on high-intensity statin); 50 patients on ezetimibe; 10 patients on lomitapide; and 10 patients undergoing apheresis. Mean baseline LDL-C was 259.6 mg/dl in the placebo group and 295.0 mg/dl in the alirocumab group. At week 12, the least squares mean difference in LDL-C percent change from baseline was -35.6% (alirocumab [-26.9%] vs. placebo [8.6%]; p < 0.0001). Reductions (least squares mean difference) in other atherogenic lipids at week 12 were: apolipoprotein B, -29.8%; non-high-density lipoprotein cholesterol, -32.9%; total cholesterol, -26.5%; and lipoprotein(a), -28.4% (all p < 0.0001). No serious adverse events, permanent treatment discontinuations, or deaths due to treatment-emergent adverse events were reported during the double-blind treatment period.
CONCLUSIONS


In the largest randomized controlled interventional trial in HoFH patients to date, alirocumab resulted in significant and clinically meaningful reductions in LDL-C at week 12. Alirocumab was generally well tolerated, with a safety profile comparable to that of placebo. (Study in Participants With Homozygous Familial Hypercholesterolemia [HoFH] [ODYSSEY HoFH] NCT03156621.).",2020,"No serious adverse events, permanent treatment discontinuations, or deaths due to treatment-emergent adverse events were reported during the double-blind treatment period.
","['67 patients receiving statin (59 patients on high-intensity statin); 50 patients on ezetimibe; 10\xa0patients\xa0on lomitapide; and 10 patients undergoing apheresis', 'Patients (N\xa0=\xa069', 'Homozygous familial hypercholesterolemia (HoFH', 'Participants With Homozygous Familial Hypercholesterolemia [HoFH', 'Adults With Homozygous Familial\xa0Hypercholesterolemia', 'adult patients with HoFH']","['alirocumab', 'proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab', 'Alirocumab', 'alirocumab or placebo', 'placebo']","['Efficacy and Safety', 'serious adverse events, permanent treatment discontinuations, or deaths due to treatment-emergent adverse events', 'LDL-C reduction', 'low-density lipoprotein-cholesterol (LDL-C) levels', 'percent reduction from baseline in LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C2827241', 'cui_str': 'lomitapide'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0342881', 'cui_str': 'Familial hypercholesterolemia - homozygous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",69.0,0.689263,"No serious adverse events, permanent treatment discontinuations, or deaths due to treatment-emergent adverse events were reported during the double-blind treatment period.
","[{'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Blom', 'Affiliation': 'Division of Lipidology and Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: dirk.blom@uct.ac.za.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Harada-Shiba', 'Affiliation': 'National Cerebral and Cardiovascular Center Research Institute, Suita, Osaka, Japan.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rubba', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Università ""Federico II"" di Napoli, Naples, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'ECOGENE-21 and Clinical Lipidology Unit, Community Gene Medicine Center, Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Charng', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Donahue', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey, and Clinical Development, R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Nagwa', 'Initials': 'N', 'LastName': 'Khilla', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey, and Clinical Development, R&D, Sanofi, Montpellier, France.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.027']
2631,32646760,Effects of an exercise programme using text messages on knee function in patients following arthroscopic knee surgery in Korea.,"AIM


The purpose of this study was to analyze the effect of an exercise programme that uses text messages on knee function after arthroscopic knee surgery.
METHODS


This was a quasi-experimental study that used the nonequivalent control group non-synchronized design. A total of 52 adult patients (25 in the experimental group and 24 in the control group). scheduled for arthroscopic knee surgery for meniscal tears were included in the study. The knee injury and osteoarthritis outcome score was used to confirm the effect. The collected data were statistically analyzed using SPSS version 23.0. Repeated-measures analysis of covariance was used to analyze symptoms, activities of daily living (ADL), and knee-related quality of life (QOL). Repeated-measures analysis of variance was used to analyze pain and sports and recreation function.
RESULTS


Significant differences in symptoms, ADL, sports and recreation function, and knee-related QOL were found according to time and group.
CONCLUSION


The use of text messages was effective as a way of promoting exercise after arthroscopic knee surgery.",2020,"RESULTS


Significant differences in symptoms, ADL, sports and recreation function, and knee-related QOL were found according to time and group.
","['patients following arthroscopic knee surgery in Korea', '52 adult patients (25 in the experimental group and 24 in the control group']","['arthroscopic knee surgery', 'exercise programme', 'exercise programme using text messages']","['symptoms, ADL, sports and recreation function, and knee-related QOL', 'knee function', 'symptoms, activities of daily living (ADL), and knee-related quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",52.0,0.044013,"RESULTS


Significant differences in symptoms, ADL, sports and recreation function, and knee-related QOL were found according to time and group.
","[{'ForeName': 'Kyung Hye', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Chonnam National University Bitgoel Hospital, Gwangju, South Korea. Electronic address: rudgp05@naver.com.'}, {'ForeName': 'Won Jun', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chonnam National University Bitgoel Hospital, Gwangju, South Korea. Electronic address: leeoojj@hanmail.net.'}, {'ForeName': 'Jong Keun', 'Initials': 'JK', 'LastName': 'Seon', 'Affiliation': 'Department of Orthopedic Surgery, Chonnam National University Hawsun Hospital, Jeollanam-do, South Korea. Electronic address: seonbell@chonnam.ac.kr.'}, {'ForeName': 'Mi Ryeong', 'Initials': 'MR', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Gachon University, Incheon, South Korea. Electronic address: miryeong@gachon.ac.kr.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2020.100789']
2632,32646811,Evaluating the Impact of Medical Student Inclusion Into Hands-On Surgical Simulation in Congenital Heart Surgery.,"OBJECTIVE


Over the last decade medical students' interest in pursuing surgery as a career has declined. This is more apparent in high-specialized specialities such as congenital heart surgery (CHS). Early hands-on simulation has shown to have a positive impact on medical students' interest in pursuing surgery, however, its incorporation into medical school curricula is lacking. This study aimed to evaluate the impact of incorporating medical students as surgical assistants during the Hands On Surgical Training course in CHS.
METHODS


Local preclinical medical students were invited to participate as surgical assistants during the 5th annual Hands On Surgical Training course in CHS. Among those who responded to the invitation, students were randomly selected and allocated to assist a congenital heart surgeon. All selected students attended an assistants' session prior to the course to familiarize themselves with assisting and to practice basic surgical skills. At the end of both courses students completed a questionnaire based on Likert 5-point scale to evaluate the courses' usefulness.
RESULTS


Fifteen medical students completed the questionnaires. All reported a beginner level of understanding of congenital heart disease. All students were highly satisfied with using 3D-printed models to help their understanding of congenital heart disease (4.80 ± 0.41) and agreed that the sessions improved their assisting skills (4.93 ± 0.26). All expressed a desire to attend similar sessions in the future and agreed that surgical simulation inclusion into medical school curricula would enhance learning (5.00 ± 0.00). Interest in pursuing a career in CHS increased from 33% (5) to 87% (13) by the end of the course.
CONCLUSIONS


Integration of preclinical medical students into surgical simulation increases interest in pursuing highly specialised surgical specialities such as CHS. Early exposure and the incorporation of such simulation programs into medical school curricula will likely improve surgical skill acquisition and may enable students to be better informed when selecting future career choices.",2020,All students were highly satisfied with using 3D-printed models to help their understanding of congenital heart disease (4.80 ± 0.41) and agreed that the sessions improved their assisting skills (4.93 ± 0.26).,"['Local preclinical medical students were invited to participate as surgical assistants during the 5th annual Hands', 'Fifteen medical students completed the questionnaires', 'Medical Student Inclusion Into Hands', ""All selected students attended an assistants' session prior to the course to familiarize themselves with assisting and to practice basic surgical skills"", 'medical students as surgical assistants during the Hands', 'Congenital Heart Surgery']",[],[],"[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]",[],[],,0.0126517,All students were highly satisfied with using 3D-printed models to help their understanding of congenital heart disease (4.80 ± 0.41) and agreed that the sessions improved their assisting skills (4.93 ± 0.26).,"[{'ForeName': 'Nicole Wing Lam', 'Initials': 'NWL', 'LastName': 'Hon', 'Affiliation': 'The Center for Image Guided Innovation and Therapeutic Intervention, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Hussein', 'Affiliation': 'Division of Cardiology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Division of Cardiovascular Surgery, Department of Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Osami', 'Initials': 'O', 'LastName': 'Honjo', 'Affiliation': 'Division of Cardiology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Division of Cardiovascular Surgery, Department of Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shi-Joon', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Diagnostic Imaging, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. Electronic address: shi-joon.yoo@sickkids.ca.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.06.023']
2633,32646823,Lack of Effect of a Multicomponent Palliative Care Program for Nursing Home Residents on Hospital Use in the Last Month of Life and on Place of Death: A Secondary Analysis of a Multicountry Cluster Randomized Control Trial.,"OBJECTIVES


PACE Steps to Success is a 1-year train-the-trainer program aiming to integrate nonspecialist palliative care into nursing homes via staff education and organizational support. In this study, we aimed to explore whether this program resulted in changes in residents' hospital use and place of death.
DESIGN


Secondary analysis of the PACE cluster randomized controlled trial (ISRCTN14741671). Data were collected on deaths over the previous 4 months via questionnaires at baseline and postintervention.
SETTING AND PARTICIPANTS


Questionnaires were completed by the nurse/care-assistant most involved from 78 nursing homes in 7 European Union countries.
MEASURES


We measured number of emergency department visits, hospital admissions, length of hospital stay, and place of death. Baseline and postintervention scores between intervention and control groups were compared, and we conducted exploratory mixed-model analyses. We collected 551 out of 610 questionnaires at baseline and 984 out of 1178 at postintervention in 37 intervention and 36 control homes.
RESULTS


We found no statistical significant effects of the program on emergency department visits [odds ratio (OR) = 1.38, P = .32], hospital admissions (OR = 0.98, P = .93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (OR = 1.08, P = .80).
CONCLUSIONS AND IMPLICATIONS


We found no effect of the PACE program on either hospital use in the last month of life or place of death. Although this may be related to implementation problems in some homes, the program might also require a more specific focus on managing acute end-of-life situations and a closer involvement of general practitioners or specialist palliative care services to influence hospital use or place of death.",2020,".93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (","['Nursing Home Residents on Hospital Use in the Last Month of Life and on Place of Death', 'We collected 551 out of 610 questionnaires at baseline and 984 out of 1178 at postintervention in 37 intervention and 36 control homes', '78 nursing homes in 7 European Union countries']","['Multicomponent Palliative Care Program', 'PACE program']","[""residents' hospital use and place of death"", 'length of hospital stay', 'emergency department visits [odds ratio (OR)\xa0', 'number of emergency department visits, hospital admissions, length of hospital stay, and place of death', 'place of death ', 'hospital admissions']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.0528792,".93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Honinx', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. Electronic address: elisabeth.honinx@vub.be.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Piers', 'Affiliation': 'Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'H Roeline W', 'Initials': 'HRW', 'LastName': 'Pasman', 'Affiliation': 'EMGO Institute for Health and Care Research, Department of Public and Occupational Health, Expertise Center for Palliative Care, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Payne', 'Affiliation': 'Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbińska', 'Affiliation': 'Department of Sociology of Medicine, Chair of Epidemiology and Preventive Medicine, Medical Faculty, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Department of Internal Medicine, Istituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Hôpitaux Universitaires de Genève, Genève, Switzerland.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.003']
2634,32646835,What muscles need to be trained for high-quality chest compression?,"BACKGROUND


This study is aimed to identify the muscles that need to be trained for high-quality cardiopulmonary resuscitation by evaluating the muscles that are fatigued during chest compression in both kneeling and standing positions.
METHODS


In this randomized crossover trial, 37 participants performed continuous chest compressions on a manikin for 5min, alternating between kneeling and standing positions. The median frequency values of 16 muscles were determined from surface electromyography recordings.
RESULTS


The median frequency values of the arm muscles (flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii) in both positions were significantly lower during the last 30s than during the first 30s, demonstrating muscle fatigue over time. The cervical erector spinae in the kneeling position and the external oblique abdominis in the standing position were also fatigued over time. In the deltoideus, quadriceps femoris, and biceps femoris muscles, the difference in median frequency between the last 30s and the first 30s was significantly different between the two positions, and muscles were more fatigued in the standing position than in the kneeling position.
CONCLUSIONS


Understanding patterns of muscle fatigue and training of these muscles would assist healthcare providers in performing high-quality chest compressions. ClinicalTrials.gov number: NCT02088879.",2020,"The median frequency values of the arm muscles (flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii) in both positions were significantly lower during the last 30s than during the first 30s, demonstrating muscle fatigue over time.",['37 participants performed'],['continuous chest compressions'],"['median frequency', 'median frequency values of the arm muscles (flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii']","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}]",37.0,0.0238009,"The median frequency values of the arm muscles (flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii) in both positions were significantly lower during the last 30s than during the first 30s, demonstrating muscle fatigue over time.","[{'ForeName': 'Yongil', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Department of Emergency Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'School of Electrical Engineering, University of Ulsan, Ulsan, Republic of Korea.'}, {'ForeName': 'Tae Ho', 'Initials': 'TH', 'LastName': 'Lim', 'Affiliation': 'Department of Emergency Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea. Electronic address: erthim@gmail.com.'}, {'ForeName': 'Youngjoon', 'Initials': 'Y', 'LastName': 'Chee', 'Affiliation': 'School of Electrical Engineering, University of Ulsan, Ulsan, Republic of Korea.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Wonhee', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Jang', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, College of Performing Arts and Sport, Hanyang University, Seoul, Republic of Korea.'}]",Australasian emergency care,['10.1016/j.auec.2020.06.002']
2635,32651132,Effects of Exergaming on Cognitive and Social Functioning of People with Dementia: A Randomized Controlled Trial.,"OBJECTIVES


Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs).
DESIGN


A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group.
SETTING AND PARTICIPANTS


A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week.
METHODS


All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD.
SECONDARY OUTCOMES


physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences.
RESULTS


Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P = .007; and Trail Making Test part A (TMT-A): r = -28.98, 95% CI: -54.89, -3.08, P = .029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = -1.86, 95% CI: -3.56, -0.17, P = .031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = -3.30, 95% CI: -6.57, -0.03, P = .048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P = .005).
CONCLUSIONS AND IMPLICATIONS


Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation.",2020,There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE):,"['day care centers (DCCs) for PwD and informal caregivers (ICs', 'people with dementia (PwD', 'A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week', 'People with Dementia', '23 DCCs across the Netherlands randomized to']","['physical exercise with cognitive stimulation', 'exergaming (interactive cycling during 6\xa0months) or a care-as-usual control group']","['Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP', 'cognition [Mini-Mental State Examination (MMSE', 'Cognitive and Social Functioning', 'burden, quality of life, and positive care experiences', 'physical, cognitive, emotional and social functioning, and quality of life for PwD', 'social functioning', 'physical activity and mobility of the PwD']","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017467', 'cui_str': 'Psychiatry, Geriatric'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.210403,There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE):,"[{'ForeName': 'Joeke', 'Initials': 'J', 'LastName': 'van Santen', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands. Electronic address: j.vandermolen@amsterdamumc.nl.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, the Netherlands; Department of Epidemiology and Biostatistics, Amsterdam UMC, VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Olivier A', 'Initials': 'OA', 'LastName': 'Blanson Henkemans', 'Affiliation': 'Child Health, TNO, Leiden, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical- Neuro- and Developmental Psychology, Faculty of Behaviour and Movement Sciences, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Franka J M', 'Initials': 'FJM', 'LastName': 'Meiland', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.04.018']
2636,32651140,Dose preservation of ligament flavum really help prevent postoperative epidural fibrosis and improve outcome in microdiscectomy?,"OBJECTIVE


A prospective, randomized, controlled clinical study was conducted with surgery performed by the same surgeon. The aim was to present a new technique for preserving the ligament flavum during lumbar microdiscectomy, and to evaluate whether this helps prevent postoperative fibrosis and improve outcome.
METHODS


From January to December 2017, 251 patients with indication for microdiscectomy were randomly divided into test group using ligament flavum preservation technique and control group using conventional procedures. Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) were assessed before the surgery, and 3 days, 1 month, 6 months, 1 year and 2 years after the operation respectively. The grade of epidural fibrosis on MRI after 6 months was evaluated by two radiologists independently and double-blindly.
RESULTS


Both groups' VAS and ODI were significantly improved after surgery, but there was no significant difference between two groups at 3d and 1 month after operation. The grade of epidural fibrosis in test group was significantly lower than that in control group at 6 months postoperative. The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
CONCLUSION


Preservation of more ligament flavum is practicable during the procedure of microdiscectomy. It can prevent postoperative epidural fibrosis, and is helpful to achieve a better clinical outcome.",2020,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","['From January to December 2017, 251 patients with indication for microdiscectomy']",['ligament flavum preservation technique and control group using conventional procedures'],"['grade of epidural fibrosis', 'Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI', 'VAS and ODI', 'postoperative epidural fibrosis']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C1041712', 'cui_str': 'Brevibacterium flavum'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3203500', 'cui_str': 'Epidural fibrosis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",251.0,0.0163517,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","[{'ForeName': 'Jigang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Laboratory, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China. Electronic address: litaozhongguo@vip.163.com.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Shandong University Qilu Hospital. Jinan City, Shandong Province, 250000, China.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.013']
2637,32651141,"Effects of Zataria oxymel on obesity, insulin resistance and lipid profile: A randomized, controlled, triple-blind trial.","BACKGROUND


Obesity is a major public health problem and its occurrence is markedly increasing in developed and developing countries. However, few studies have investigated the use of natural products to treat obesity. The effects of taking a combination of oxymel and Zataria multiflora Boiss. (ZM), herein referred to as Zataria oxymel (ZO), on obesity, lipid profile and insulin resistance have not yet been studied.
OBJECTIVE


This study evaluates the effects of oxymel and ZO on obesity, lipid profile and insulin resistance.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


In this randomized, controlled, triple-blind trial, overweight patients were randomly divided into three groups and received doses of study compounds twice per day for twelve weeks. Group A received 0.75 g ZM in 10 mL oxymel in each treatment; group B received 1.5 g ZM in 10 mL of oxymel in each treatment and group C (control) only received 10 mL of oxymel in each treatment.
MAIN OUTCOME MEASURES


Anthropometric parameters, including body mass index (BMI), waist circumference and hip circumference, were measured at the time of registration. Blood tests were carried out at the beginning and once again at end of the study. Blood parameters included fasting blood sugar (FBS), insulin levels, serum lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol) and liver enzymes (aspartate transaminase and alanine transaminase). Serum creatinine was also measured at the beginning of the project and in monthly intervals for three months. The homeostasis model assessment index was calculated as fasting insulin (μIU/mL) × FBS (mg/dL)/405.
RESULTS


The results showed that patients receiving ZO experienced significant reduction in waist circumference in groups A, B and C, respectively (P < 0.001) but no significant change in BMI. Group A also experienced reduction in hip circumference (P = 0.01). Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS. No effect on lipid profile, liver enzymes or serum creatinine was observed in the three groups.
CONCLUSION


In this study, treatment with ZO and oxymel reduced insulin resistance, and waist and hip circumferences in overweight patients. Nonetheless, the traditional Persian use of ZO as a beverage to improve the anthropometric indices in overweight individuals still requires further research with a larger sample size.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials Code IRCT20171220037976N1.",2020,"Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS.",['overweight patients'],"['ZM', 'ZM in 10\xa0mL of oxymel in each treatment and group C (control) only received 10\xa0mL of oxymel in each treatment', 'Zataria oxymel', 'oxymel and ZO']","['homeostasis model assessment index', 'Anthropometric parameters, including body mass index (BMI), waist circumference and hip circumference', 'waist circumference', 'hip circumference', 'homeostatic model assessment of insulin resistance', 'insulin resistance, and waist and hip circumferences', 'lipid profile, liver enzymes or serum creatinine', 'Serum creatinine', 'BMI', 'obesity, insulin resistance and lipid profile', 'FBS', 'fasting blood sugar (FBS), insulin levels, serum lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol) and liver enzymes (aspartate transaminase and alanine transaminase', 'obesity, lipid profile and insulin resistance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0641254,"Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS.","[{'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Farboodniay Jahromi', 'Affiliation': 'Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossein Sharifi', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Nutrition, School of Health and Nutrition, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Hosseini', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Nasrindokht', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nimrouzi', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran. Electronic address: mnimruzi@yahoo.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.06.003']
2638,32651338,"A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.","BACKGROUND


Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.
OBJECTIVE


Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a > 20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration.
METHODS


This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1 : 1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.
RESULTS


The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3study groups: (14.9 + 40.0 feet; 19.4 + 39.6 feet; and 20.4 + 38.3 feet for placebo, 7.5 mg D-ER, and 10mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were non significant changes from baseline for all groups.
CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).",2020,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","['stroke survivors with gait impairment', '377 of planned 540 patients enrolled, due to no treatment effect', 'ischemic stroke']","['Dalfampridine extended release tablets (D-ER', '7.5\u200amg D-ER, 10\u200amg D-ER, or placebo', 'D-ER', 'dalfampridine', 'placebo']","['distances walked', '2-minute walk test (2\u200aMinWT', 'walking deficits']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",540.0,0.674871,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Page', 'Affiliation': 'Neurorecovery Unlimited, LLC, Columbus, OH.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Bockbrader', 'Affiliation': 'Ohio State University Medical Center, Columbus, OH.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'JEM Research Institute, Atlantis, FL.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Finklestein', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'MingMing', 'Initials': 'M', 'LastName': 'Ning', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Waleed H', 'Initials': 'WH', 'LastName': 'El-Feky', 'Affiliation': 'Texas Neurology, Dallas, TX.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Wilson', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Restorative neurology and neuroscience,['10.3233/RNN-201009']
2639,32651477,Modifiable predictors of nonresponse to psychotherapies for late-life depression with executive dysfunction: a machine learning approach.,"The study aimed to: (1) Identify distinct trajectories of change in depressive symptoms by mid-treatment during psychotherapy for late-life depression with executive dysfunction; (2) examine if nonresponse by mid-treatment predicted poor response at treatment end; and (3) identify baseline characteristics predicting an early nonresponse trajectory by mid-treatment. A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy. We used Latent Growth Mixture Models (LGMM) to detect subgroups with distinct trajectories of change in depression by mid-treatment (6th week). We conducted regression analyses with LGMM subgroups as predictors of response at treatment end. We used random forest machine learning algorithms to identify baseline predictors of LGMM trajectories. We found that ~77.5% of participants had a declining trajectory of depression in weeks 0-6, while the remaining 22.5% had a persisting depression trajectory, with no treatment differences. The LGMM trajectories predicted remission and response at treatment end. A random forests model with high prediction accuracy (80%) showed that the strongest modifiable predictors of the persisting depression trajectory were low perceived social support, followed by high neuroticism, low treatment expectancy, and low perception of the therapist as accepting. Our results suggest that modifiable risk factors of early nonresponse to psychotherapy can be identified at the outset of treatment and addressed with targeted personalized interventions. Therapists may focus on increasing meaningful social interactions, addressing concerns related to treatment benefits, and creating a positive working relationship.",2020,A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy.,"['221 adults 60 years and older with major depression and executive dysfunction', 'late-life depression with executive dysfunction']","['problem-solving therapy or supportive therapy', 'Latent Growth Mixture Models (LGMM']","['persisting depression trajectory', 'depressive symptoms', 'trajectory of depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",221.0,0.0201383,A sample of 221 adults 60 years and older with major depression and executive dysfunction were randomized to 12 weeks of either problem-solving therapy or supportive therapy.,"[{'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Flückiger', 'Affiliation': 'Psychologisches Institut, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Kanellopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Feil Family Brain Mind Research Institute, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Hull', 'Affiliation': 'Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, NY, USA. gsalexop@med.cornell.edu.'}]",Molecular psychiatry,['10.1038/s41380-020-0836-z']
2640,32651582,Injuries on the Youth Soccer (Football) Field: Do Additional Referees Reduce Risk? Randomized Crossover Trial.,"OBJECTIVE


Youth soccer injury can be prevented through various means, but few studies consider the role of referees. Following previous research suggesting children take fewer risks when supervised intensely, this randomized crossover trial evaluated whether risky play and injuries decrease under supervision from three referees instead of one referee.
METHODS


Youth soccer clubs serving a metropolitan U.S. area participated. Boys' and girls' clubs at under age 10 (U10) and under age 11 (U11) levels were randomly assigned such that when the same clubs played each other twice in the same season, they played once with one referee and once with three referees. A total of 98 games were videotaped and subsequently coded to obtain four outcomes: collisions between players, aggressive fouls (involving physical player-to-player contact) called by the referee(s) on the field, aggressive fouls judged by trained coders, and injuries requiring adult attention or play stoppage.
RESULTS


Poisson mixed model results suggest players in the 98 games committed fewer aggressive fouls, as identified independently by referees (rate ratio [RR] 0.58; 95% confidence interval [CI] 0.35-0.96) and by researchers (RR 0.67; 95% CI 0.50-0.90), when there were three referees versus one referee. Collisions (RR 0.98; 95% CI 0.86-1.12) and injury rates (RR 1.15; 95% CI 0.60-2.19) were similar across conditions.
CONCLUSION


When the same youth soccer clubs played with three referees rather than one, they committed fewer aggressive fouls. More intense supervision created better rule adherence. Injury rates were unchanged with increased supervision. Results raise questions concerning whether financial investment in additional referees on youth soccer fields yields safety benefits.",2020,"Collisions (RR 0.98; 95% CI 0.86-1.12) and injury rates (RR 1.15; 95% CI 0.60-2.19) were similar across conditions.
","['Youth soccer clubs serving a metropolitan U.S. area participated', ""Boys' and girls' clubs at under age 10 (U10) and under age 11 (U11) levels""]","['videotaped and subsequently coded to obtain four outcomes: collisions between players, aggressive fouls (involving physical player-to-player contact) called by the referee(s) on the field, aggressive fouls judged by trained coders, and injuries requiring adult attention or play stoppage']","['injury rates', 'Injury rates', 'aggressive fouls']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",98.0,0.150697,"Collisions (RR 0.98; 95% CI 0.86-1.12) and injury rates (RR 1.15; 95% CI 0.60-2.19) were similar across conditions.
","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham.'}, {'ForeName': 'D Leann', 'Initials': 'DL', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'Department of Epidemiology and Biostatistics, Drexel University.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa050']
2641,32651585,Music Therapy to Regulate Arousal and Attention in Patients With Substance Use Disorder and Posttraumatic Stress Disorder: A Feasibility Study.,"Patients diagnosed with both substance use disorder (SUD) and posttraumatic stress disorder (PTSD) often experience hypervigilance, increased fear, and difficulties regulating emotions. This dual diagnosis increases treatment complexity. Recently, a short-term music therapy intervention for arousal and attention regulation (the SMAART intervention) was designed based on neurobiological findings. Twelve patients with SUD and PTSD (50% females) in outpatient treatment participated in six weekly one-hour sessions of the SMAART intervention. Six patients completed the study. PTSD symptom severity was evaluated with the Posttraumatic Stress Disorder Symptom Scale Interview for DSM-5 (PSSI-5) pre- and post-intervention, and sustained attention was evaluated with the Bourdon-Wiersma (BW) test. A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention. Furthermore, participants showed significant improvement on subscales of hyperarousal, mood and cognition, and attention. The BW test completion time decreased significantly. Two participants dropped out before the end of the intervention due to craving. Concerning future research, it is recommended to define the role of the music more explicitly and to change the design to a randomized controlled trial. A risk for future larger studies is a high dropout rate (50%). Several limitations of the study are discussed.",2020,A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention.,"['Six patients completed the study', 'Posttraumatic Stress Disorder', 'Patients', 'Patients diagnosed with both substance use disorder (SUD) and posttraumatic stress disorder (PTSD', 'Twelve patients with SUD and PTSD (50% females']",['Music Therapy'],"['PTSD symptom severity', 'BW test completion time', 'subscales of hyperarousal, mood and cognition, and attention', 'PSSI-5 overall symptom severity', 'Posttraumatic Stress Disorder Symptom Scale Interview for DSM-5']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",12.0,0.0188963,A significant difference in measurements for the PSSI-5 overall symptom severity was found pre- and post-intervention.,"[{'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Hakvoort', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Sirik', 'Initials': 'S', 'LastName': 'de Jong', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'van de Ree', 'Affiliation': 'ArtEZ University of the Artsm, Enschede, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kok', 'Affiliation': 'Tactus, Addiction Care Twente, Enschede, The Netherlands.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Macfarlane', 'Affiliation': 'Penitentiary Psychiatric Center Institution Vught & Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Haan', 'Affiliation': 'Tactus, Addiction Care Twente, Enschede, The Netherlands.'}]",Journal of music therapy,['10.1093/jmt/thaa007']
2642,32651587,Epidural Anesthesia in Liver Surgery-A Propensity Score-Matched Analysis.,"OBJECTIVE


To assess the effects of epidural anesthesia (EA) on patients who underwent liver resection.
DESIGN


Secondary analysis of a prospective randomized controlled trial.
SETTING


This single-center study was conducted at an academic medical center.
METHODS


A subset of 110 1:1 propensity score-matched patients who underwent liver resection with and without EA were analyzed. Outcome measures were pain intensity ≥5 on a numeric rating scale (NRS) at rest and during movement on postoperative days 1-5, analyzed with logistic mixed-effects models, and postoperative complications according to the Clavien-Dindo classification, length of hospital stay (LOS), and one-year survival. One-year survival in the matched cohorts was compared using a frailty model.
RESULTS


EA patients were less likely to experience NRS ≥5 at rest (odds ratio = 0.06, 95% confidence interval [CI] = 0.01 to 0.28, P < 0.001). These findings were independent of age, sex, Charlson comorbidity index, baseline NRS, and surgical approach (open vs laparoscopic). The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively). Reduced mortality rates were seen in the EA group one year after surgery (9.1% vs 30.9%, hazard ratio = 0.32, 95% CI = 0.11 to 0.90, P = 0.031). No EA-related adverse events occurred. Earlier recovery of bowel function was seen in EA patients.
CONCLUSIONS


Patients with EA had better postoperative pain control and required fewer systemic opioids. Postoperative complications and LOS did not differ, although one-year survival was significantly improved in patients with EA. EA applied in liver surgery was effective and safe.",2020,"The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively).","['patients who underwent liver resection', 'This single-center study was conducted at an academic medical center']","['Epidural Anesthesia', 'epidural anesthesia (EA', 'liver resection with and without EA']","['year survival', 'mortality rates', 'Postoperative complications and LOS', 'bowel function', 'postoperative pain control', 'systemic opioids', 'number and severity of postoperative complications and LOS', 'pain intensity ≥5 on a numeric rating scale (NRS) at rest and during movement on postoperative days 1-5, analyzed with logistic mixed-effects models, and postoperative complications according to the Clavien-Dindo classification, length of hospital stay (LOS), and one-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",,0.132358,"The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively).","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Knaak', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Jara', 'Affiliation': 'Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Vorderwülbecke', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Anna Dorothea', 'Initials': 'AD', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'von Haefen', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Lachmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Schulte', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa130']
2643,32651595,Radiation-induced DNA double-strand breaks in peripheral leukocytes and therapeutic response of heel spur patients treated by orthovoltage X-rays or a linear accelerator.,"PURPOSE


Biodosimetric assessment and comparison of radiation-induced deoxyribonucleic acid (DNA) double-strand breaks (DSBs) by γH2AX immunostaining in peripheral leukocytes of patients with painful heel spur after radiation therapy (RT) with orthovoltage X‑rays or a 6-MV linear accelerator (linac). The treatment response for each RT technique was monitored as a secondary endpoint.
PATIENTS AND METHODS


22 patients were treated either with 140-kV orthovoltage X‑rays (n = 11) or a 6-MV linac (n = 11) with two weekly fractions of 0.5 Gy for 3 weeks. In both scenarios, the dose was prescribed to the International Commission on Radiation Units and Measurements (ICRU) dose reference point. Blood samples were obtained before and 30 min after the first RT session. γH2AX foci were quantified by immunofluorescence microscopy to assess the yield of DSBs at the basal level and after radiation exposure ex vivo or in vivo. The treatment response was assessed before and 3 months after RT using a five-level functional calcaneodynia score.
RESULTS


RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes. No difference between the RT techniques was observed. High and comparable therapeutic responses were documented for both treatment modalities. This trial was terminated preliminarily after an interim analysis (22 patients randomized).
CONCLUSION


Low-dose RT for painful heel spurs with orthovoltage X‑rays or a 6-MV linac is an effective treatment option associated with a very low and comparable radiation burden to the patient, as confirmed by biodosimetric measurements.",2020,"RESULTS


RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes.","['22\xa0patients were treated either with', 'patients with painful heel spur after radiation therapy (RT) with orthovoltage X‑rays or a\xa06-MV linear accelerator (linac']","['140-kV orthovoltage X‑rays (n\u202f=\u200911) or a\xa06-MV linac', 'Radiation-induced DNA double-strand breaks', 'radiation-induced deoxyribonucleic acid (DNA) double-strand breaks (DSBs) by γH2AX immunostaining']","['Blood samples', 'γH2AX foci']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal spur'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0023730', 'cui_str': 'Linear accelerator'}]","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023730', 'cui_str': 'Linear accelerator'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0311474', 'cui_str': 'Deoxyribonucleic acid, double stranded'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.0289989,"RESULTS


RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zahnreich', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany. zahnreic@uni-mainz.de.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Rösler', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Schwanbeck', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Karle', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01662-4']
2644,32651634,Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest.,"PURPOSE


To compare endocrine responses to intermittent vs continuous enteral nutrition provision during short-term bed rest.
METHODS


Twenty healthy men underwent 7 days of bed rest, during which they were randomized to receive enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre) in a continuous (CONTINUOUS; n = 10; 24 h day -1  at a constant rate) or intermittent (INTERMITTENT; n = 10; as 4 meals per day separated by 5 h) pattern. Daily plasma samples were taken every morning to assess metabolite/hormone concentrations.
RESULTS


During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 pmol L -1  in CONTINUOUS, compared to 94 ± 38 pmol L -1  in INTERMITTENT (P = 0.001). Changes in glucose infusion rate were positively correlated with changes in fasting plasma GLP-1 concentrations (r = 0.44, P = 0.049).
CONCLUSION


Intermittent enteral nutrition attenuates the progressive rise in plasma leptin and insulinemia seen with continuous feeding during bed rest, suggesting that continuous feeding increases insulin requirements to maintain euglycemia. This raises the possibility that hepatic insulin sensitivity is impaired to a greater extent with continuous versus intermittent feeding during bed rest. To attenuate endocrine and metabolic changes with enteral feeding, an intermittent feeding strategy may, therefore, be preferable to continuous provision of nutrition. This trial was registered on clinicaltrials.gov as NCT02521025.",2020,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","['Twenty healthy men underwent 7\xa0days of bed rest, during which they were randomized to receive']","['enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre', 'continuous enteral nutrition']","['Changes in glucose infusion rate', 'insulin concentrations (interaction effect', 'insulin and leptin', 'fasting plasma GLP-1 concentrations', 'plasma leptin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",20.0,0.0678729,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","[{'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. J.T.Gonzalez@bath.ac.uk.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Imre W K', 'Initials': 'IWK', 'LastName': 'Kouw', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04431-4']
2645,32651644,Comparison between isolated and associated with codeine acetaminophen in pain control of acute apical abscess: a randomized clinical trial.,"OBJECTIVES


The study aimed to compare the acetaminophen administration efficacy or its combination with codeine for pain control in acute apical abscesses cases.
MATERIALS AND METHODS


Thirty-nine patients who sought emergency treatment in the Faculty of Dentistry of the Federal University of Rio Grande do Sul were included, all of them with acute apical abscess diagnosis. These patients were divided into two groups: acetaminophen group-prescription of acetaminophen (1000 mg) and acetaminophen-codeine group-prescription of acetaminophen (1000 mg) + codeine (30 mg), both with oral intake every 6 h for 3 days. The pain scores were recorded by the patients on their own at 6, 12, 24, 48, and 72 h after finishing clinical assistance, by filling a pain evolution journal, containing a visual analogue scale (VAS). Student t test was conducted to investigate different mean ages between groups 1 and 2. A comparison of weight and means of initial pain scores between groups was carried out using the Mann-Whitney U test. Chi-square test was performed to compare gender, affected tooth, education, initial swelling, and frequency of adverse effect between test and control groups. Mann-Whitney U test was applied to compare groups in the same period. Friedman's test was used to compare results from the same group over time.
RESULTS


Both groups showed score reduction over time (P < 0.05). Paracetamol-codeine group showed significant pain score reduction at 48 h registers when compared to baseline and at 6 h scores (P < 0.05). Further, pain scores at 72 h were significantly lower, when compared to the baseline, at 6 h, and at 12 h scores (P < 0.05). Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05). There were no significant differences in pain score reduction over time between groups (P > 0.05). There was no difference between the groups regarding the frequency of adverse reactions (P > 0.05).
CONCLUSION


Both medications were effective for pain control in acute apical abscess cases. The findings might have inferred in pain control of acute apical abscess associated pain in patients who used an antibiotic drug. External validity of the findings for acute apical abscess cases with no need for an antibiotic prescription is uncertain.
CLINICAL RELEVANCE


This paper suggests acetaminophen 1000 mg can be used for pain control in the treatment of acute apical abscess associated with systemic manifestation.",2020,"Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05).","['patients who used an antibiotic drug', 'pain control of acute apical abscess', 'Thirty-nine patients who sought emergency treatment in the Faculty of Dentistry of the Federal University of Rio Grande do Sul were included, all of them with acute apical abscess diagnosis', 'acute apical abscesses cases']","['Acetaminophen', 'codeine', 'Paracetamol-codeine', 'acetaminophen-codeine group-prescription of acetaminophen (1000\xa0mg)\u2009+\u2009codeine', 'codeine acetaminophen', 'acetaminophen group-prescription of acetaminophen', 'acetaminophen']","['pain scores', 'initial pain scores', 'pain score reduction', 'frequency of adverse reactions', 'visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1290646', 'cui_str': 'Acute apical abscess'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0013969', 'cui_str': 'Emergency treatment'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C2351132', 'cui_str': 'codeine and paracetamol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",39.0,0.0436955,"Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05).","[{'ForeName': 'Paula Barcellos', 'Initials': 'PB', 'LastName': 'da Silva', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Aline Teixeira', 'Initials': 'AT', 'LastName': 'Mendes', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maria Beatriz Ferreira', 'Initials': 'MBF', 'LastName': 'Cardoso', 'Affiliation': 'Pharmacology Department, Basic Health Sciences Institute, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo Abreu', 'Initials': 'RA', 'LastName': 'da Rosa', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Angela Longo', 'Initials': 'AL', 'LastName': 'do Nascimento', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jefferson Ricardo', 'Initials': 'JR', 'LastName': 'Pereira', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, University of Southern Santa Catarina, Tubarão, SC, Brazil.'}, {'ForeName': 'Marcus Vinícius Reis', 'Initials': 'MVR', 'LastName': 'Só', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil. endo-so@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03374-6']
2646,32651772,Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.,"BACKGROUND


Acute ST-elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. Primary percutaneous coronary intervention (PCI) has improved the outcomes from STEMI and improved myocardial perfusion. However, there is still room for medical therapy to help perfuse the myocardium. The aim of this study was to assess the impact of high-intensity statins used prior to primary PCI in patients presenting with acute STEMI on myocardial perfusion. The study included 170 patients who presented with acute STEMI to Ain Shams University Hospitals and underwent primary percutaneous coronary intervention (PCI). They were divided into two groups where the first group received high-intensity statins (80 mg of atorvastatin or 20 mg of rosuvastatin) besides guideline-recommended therapy before primary PCI and the second group served as a control group and received guideline-recommended therapy, and high-intensity statins were given as usual after going back to the coronary care unit after primary PCI. Post-interventional thrombolysis in myocardial infarction (TIMI) flow grade and myocardial blush grade (MBG) were recorded, and ST-segment resolution was measured.
RESULTS


The LAD was the culprit vessel for the majority of patients in both groups. In the control group, there were 4 patients with TIMI I flow and MBG I, 13 with TIMI II flow and MBG II, and 68 with TIMI III flow and MBG III. Meanwhile, in the cases group, there was 1 patient with TIMI I flow and MBG I, 3 with TIMI II flow and MBG II, and 81 with TIMI III flow and MBG III. This difference was statistically significant with a P value of 0.010. There were 34 patients in the cases group who showed complete ST-segment resolution (40%) vs. 19 patients (22.4%) in the control group which was statistically significant with a P value of 0.013. In addition, ejection fraction had values of mean ± SD of 45.91 ± 5.49 in the cases group vs. 43.01 ± 8.80 in the control group which was statistically significant with a P value of 0.011.
CONCLUSION


High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.",2020,"High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.","['patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention', '170 patients who presented with acute STEMI to Ain Shams University Hospitals and underwent primary percutaneous coronary intervention (PCI', 'patients presenting with acute STEMI on myocardial perfusion', '4 patients with TIMI']","['high-intensity statin preloading', 'TIMI', 'Primary percutaneous coronary intervention (PCI', 'high-intensity statins (80\u2009mg of atorvastatin or 20\u2009mg of rosuvastatin) besides guideline-recommended therapy before primary PCI and the second group served as a control group and received guideline-recommended therapy, and high-intensity statins']","['complete ST-segment resolution', 'myocardial infarction (TIMI) flow grade and myocardial blush grade (MBG', 'TIMI flow', 'post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction', 'myocardial perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}]",170.0,0.0172981,"High-intensity statin loading before primary PCI resulted in improved post-procedural TIMI flow, MBG, complete ST-segment resolution, and ejection fraction.","[{'ForeName': 'Ahmed Shawky', 'Initials': 'AS', 'LastName': 'Elserafy', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. ahmedshawkyelserafy@gmail.com.'}, {'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Farag', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Ahmed Ibrahim', 'Initials': 'AI', 'LastName': 'El Desoky', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Khaled Adel', 'Initials': 'KA', 'LastName': 'Eletriby', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00074-0']
2647,32651812,Psychophysiological Analysis of Thymoleptic Effects of Xenon in Humans.,"This pilot study was aimed at evaluation of the translational potential of xenon as a potential antidepressant. In placebo-controlled double-blind study, 14 healthy right-handed volunteers were randomly assigned to 15-min inhalation session of either gas mixture with xenon (25%Хе/30%О 2 /45%N 2 ) or placebo (70%N 2 /30%О 2 ) with simultaneous recording of 64-channel EEG. To assess the dynamics and nature of emotional activation in response to xenon and placebo, we analyzed both the intensity of positive and negative emotions and individual alpha peak frequency (iAPF) of EEG. We found that xenon in sub-anesthetic doses promoted positive emotional arousal, and that emotional response to xenon depended on individual neurophysiological endophenotype of alpha-activity (iAPF). The authors suggest that iAPF shifts can be used as a neurophysiological predictor of individual thymoleptic response to xenon.",2020,"We found that xenon in sub-anesthetic doses promoted positive emotional arousal, and that emotional response to xenon depended on individual neurophysiological endophenotype of alpha-activity (iAPF).","['14 healthy right-handed volunteers', 'Humans']","['gas mixture with xenon (25%Хе/30%О 2 /45%N 2 ) or placebo (70%N 2 /30%О 2 ) with simultaneous recording of 64-channel EEG', 'placebo']","['intensity of positive and negative emotions and individual alpha peak frequency (iAPF) of EEG', 'positive emotional arousal', 'individual neurophysiological endophenotype of alpha-activity (iAPF']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0581444', 'cui_str': 'Gas mixture'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2936327', 'cui_str': 'Endophenotypes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",14.0,0.125353,"We found that xenon in sub-anesthetic doses promoted positive emotional arousal, and that emotional response to xenon depended on individual neurophysiological endophenotype of alpha-activity (iAPF).","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Aftanas', 'Affiliation': 'Reasearch Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Bazanova', 'Affiliation': 'Reasearch Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia. bazanovaom@physiol.ru.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Khabarov', 'Affiliation': 'Reasearch Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Pustovoyt', 'Affiliation': 'Reasearch Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}]",Bulletin of experimental biology and medicine,['10.1007/s10517-020-04846-1']
2648,32651867,Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial - Correspondence.,,2020,,['Migraine Headache in Children'],['Paracetamol versus Ibuprofen'],[],"[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],,0.30835,,"[{'ForeName': 'Prateek Kumar', 'Initials': 'PK', 'LastName': 'Panda', 'Affiliation': 'Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Indar Kumar', 'Initials': 'IK', 'LastName': 'Sharawat', 'Affiliation': 'Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India. sherawatdrindar@gmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03437-2']
2649,32651877,Comparison of the effect of whole-body vibration therapy versus conventional therapy on functional balance of patients with Parkinson's disease: adding a mixed group.,"OBJECTIVE


Assess the effect of Whole-Body Vibration (WBV) therapy in functional balance status of Parkinson's disease (PD) patients and compare this to conventional and combined therapy.
INTRODUCTION


PD patients experience a decreased mobility, inactivity, and loss of independence as consequence of disturbances in gait, posture, and balance. Rehabilitation therapy is a non-pharmacological way of improving functionality. One of the most studied modalities is WBV, with multiple studies showing improvement in motor function. However, results in this manner are inconsistent.
METHODS


Forty-five patients were enrolled in a non-randomized controlled trial and divided into three groups. Group 1 received conventional therapy (thermotherapy, stretching, strengthening, coordination and balance). Group 2 received WBV therapy, and group 3 patients underwent a combined therapy protocol. A total of 20 sessions (3 per week) were conducted, assessing Berg Balance Scale (BBS) before initial and after final session.
RESULTS


The 3 intervention groups showed significant improvement in BBS scores after concluding the 20-session trial compared to initial assessment. When comparing mean change in BBS score from initial to final assessment, the combined therapy group had a greater increase compared to conventional therapy, but no significant differences were observed comparing to WBV group. Mean change in BBS score showed no significant difference between conventional therapy and WBV therapy group.
CONCLUSIONS


WBV therapy is a useful tool as co-adjuvant in conventional therapy. The combination of both therapies is a significant therapeutic alternative for the improvement of functional balance status in PD patients compared to conventional therapy alone.",2020,The combination of both therapies is a significant therapeutic alternative for the improvement of functional balance status in PD patients compared to conventional therapy alone.,"[""patients with Parkinson's disease"", ""Parkinson's disease (PD) patients"", 'Forty-five patients', 'PD patients']","['Rehabilitation therapy', 'combined therapy protocol', 'whole-body vibration therapy', 'conventional therapy (thermotherapy, stretching, strengthening, coordination and balance', 'conventional therapy', 'WBV therapy', 'Whole-Body Vibration (WBV) therapy']","['Berg Balance Scale (BBS', 'BBS score', 'functional balance status', 'Mean change in BBS score', 'BBS scores', 'functional balance', 'motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",45.0,0.0110709,The combination of both therapies is a significant therapeutic alternative for the improvement of functional balance status in PD patients compared to conventional therapy alone.,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Guadarrama-Molina', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Carlos Enrique', 'Initials': 'CE', 'LastName': 'Barrón-Gámez', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Estrada-Bellmann', 'Affiliation': 'Neurology Division, Internal Medicine Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Madero y Gonzalitos S/N, Monterrey, Nuevo León, 64700, México. ingridestmann@hotmail.com.'}, {'ForeName': 'Jesús D', 'Initials': 'JD', 'LastName': 'Meléndez-Flores', 'Affiliation': 'Neurology Division, Internal Medicine Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Madero y Gonzalitos S/N, Monterrey, Nuevo León, 64700, México.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ramírez-Castañeda', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Rosa María Gisela', 'Initials': 'RMG', 'LastName': 'Hernández-Suárez', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Minerva', 'Initials': 'M', 'LastName': 'Menchaca-Pérez', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Salas-Fraire', 'Affiliation': 'Sports Medicine and Rehabilitation Department, University Hospital ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, México.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01439-7']
2650,32651955,"Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease.","BACKGROUND


Hyperphosphataemia is a common complication of chronic kidney disease (CKD). PT20 (ferric iron oxide adipate) is an investigational molecule engineered to offer enhanced phosphate-binding properties relative to other phosphate binders.
METHODS


In this double-blind, parallel-group, placebo-controlled, dose-ranging study (ClinicalTrials.gov identifier NCT02151643), the efficacy and safety of 28 days of oral PT20 treatment were evaluated in patients with dialysis-dependent CKD. Participants were randomly assigned in an 8:8:8:13:13 ratio to receive PT20 (400, 800, 1600 or 3200 mg) or placebo three times daily.
RESULTS


Among 153 participants, 129 completed treatment [7 discontinued because of adverse events (AEs), 2 because of hyperphosphataemia and 15 for other reasons]. PT20 treatment for 28 days resulted in a statistically significant and dose-dependent reduction in serum phosphate concentration. There were no statistically significant effects of PT20 treatment on changes in haemoglobin or ferritin concentrations or transferrin saturation between Days 1 and 29. The incidence of treatment-emergent AEs was broadly similar across the PT20 and placebo groups (42-59% versus 44%). The most common PT20 treatment-related AEs were gastrointestinal, primarily diarrhoea (13-18%) and discoloured faeces (3-23%). No serious AEs were considered to be related to study treatment. There were no clinically significant changes in laboratory results reflecting acid/base status or increases in ferritin that could indicate the absorption of components of PT20.
CONCLUSIONS


In this first study investigating the efficacy and safety of PT20 in patients with hyperphosphataemia and dialysis-dependent CKD, PT20 significantly lowered serum phosphate concentrations and was generally well tolerated.",2020,There were no statistically significant effects of PT20 treatment on changes in haemoglobin or ferritin concentrations or transferrin saturation between Days 1 and 29.,"['patients with dialysis-dependent CKD', 'patients with haemodialysis-dependent chronic kidney disease', 'hyperphosphataemia', '153 participants, 129 completed treatment [7 discontinued because of adverse events (AEs), 2 because of hyperphosphataemia and 15 for other reasons', 'patients with hyperphosphataemia and dialysis-dependent CKD']","['PT20, an iron-based phosphate binder', 'PT20 (ferric iron oxide adipate', 'PT20', 'placebo three times daily', 'placebo']","['haemoglobin or ferritin concentrations or transferrin saturation', 'gastrointestinal, primarily diarrhoea', 'serum phosphate concentration', 'efficacy and safety', 'efficacy and safety of PT20', 'incidence of treatment-emergent AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0050846', 'cui_str': 'adipic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.25569,There were no statistically significant effects of PT20 treatment on changes in haemoglobin or ferritin concentrations or transferrin saturation between Days 1 and 29.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Shield Therapeutics PLC, London, UK.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Faria', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Powell', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa116']
2651,32649615,Valproic Acid Decreases Resuscitation Requirements After Hemorrhage in a Prolonged Damage Control Resuscitation Model.,"BACKGROUND


Hemorrhage is the leading cause of preventable death in trauma. Future military conflicts are likely to be in austere environments, where prolonged damage control resuscitation (p-DCR) may be required for 72 hours before evacuation. There is a need to demonstrate p-DCR is feasible and to optimize its logistics. Dried plasma (DP) is a practical alternative to conventional blood products in austere settings, and valproic acid (VPA) improves survival in preclinical models of trauma and hemorrhage. We performed the current experiment to study the synergistic effects of VPA and DP and hypothesized that VPA treatment would decrease the fluid resuscitation requirements in p-DCR.
METHODS


Female swine were subjected to 50% hemorrhage (associated with 20% survival using non-plasma-based p-DCR) and left unresuscitated for one hour to simulate medic response time. They were then randomized to receive VPA (150 mg/kg+DP 250 mL; DP+VPA group; n=5) or DP alone (DP group; n=6). All animals were resuscitated to a systolic blood pressure (SBP) of 80 mmHg with lactated Ringer's (LR) according to the Tactical Combat Casualty Care Guidelines for 72 hours, after which packed red blood cells were transfused to simulate evacuation to higher levels of care.
RESULTS


The DP+VPA group needed significantly (p=0.002) less volume of LR to reach and maintain the target SBP. This would translate to a 4.3L volume sparing effect for a 70kg person.
CONCLUSION


Addition of a single dose of VPA significantly decreases the volume of resuscitation required in a p-DCR model.
LEVEL OF EVIDENCE


Not applicable. Basic science.",2020,The DP+VPA group needed significantly (p=0.002) less volume of LR to reach and maintain the target SBP.,['Female swine were subjected to 50% hemorrhage (associated with 20% survival using non-plasma-based p-DCR) and left unresuscitated for one hour to simulate medic response time'],"['kg+DP 250 mL; DP+VPA', 'VPA', ""lactated Ringer's (LR"", 'DP+VPA', 'VPA and DP', 'DP alone', 'Dried plasma (DP']","['volume of resuscitation', 'volume of LR to reach and maintain the target SBP', 'fluid resuscitation requirements', 'Valproic Acid Decreases Resuscitation Requirements', 'systolic blood pressure (SBP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0358142,The DP+VPA group needed significantly (p=0.002) less volume of LR to reach and maintain the target SBP.,"[{'ForeName': 'Ben E', 'Initials': 'BE', 'LastName': 'Biesterveld', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Kemp', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ali Z', 'Initials': 'AZ', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Alizeh', 'Initials': 'A', 'LastName': 'Shamshad', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kiril', 'Initials': 'K', 'LastName': 'Chtraklin', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Umar F', 'Initials': 'UF', 'LastName': 'Bhatti', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002876']
2652,32649617,Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery - a randomized-controlled clinical trial.,"BACKGROUND


Open, emergency abdominal surgery is associated with a high incidence of fascial dehiscence and incisional hernia. Implantation of biologic meshes potentially reinforce the abdominal wall and therefore decrease such complications. The aim of this prospective, randomized study was to compare the outcome after prophylactic, intraperitoneal implantation of a biologic Strattice mesh with standard abdominal closure in patients undergoing emergency abdominal surgery.
METHODS


A two-arm randomized clinical trial was performed in patients undergoing emergency abdominal surgery at Bern University Hospital, Switzerland from April 2016 to March 2019. Patients were randomly assigned to prophylactic implantation of a biological intraperitoneal mesh using Strattice, Allergan (mesh group) or standard abdominal closure using a single, continuous running suture (no mesh group). Because of safety concerns, patient enrollment had to be closed prematurely.
RESULTS


Eligibility for inclusion was assessed in 61 patients. A total of 48 patients were randomized (21 in the mesh group, 28 in the no-mesh group). No differences in baseline characteristics were found. Abdominal wall complications requiring re-operations were more frequent in the mesh group compared to the no mesh group (5 of 13 [83.3%] vs 1 of 13 [14.3%] patients, p=0.026). Mesh-associated abdominal wall complications included non-integration of the mesh into the abdominal wall, dissolution of the mesh, and mesh-related infections.
CONCLUSION


In patients undergoing emergency abdominal surgery, intraperitoneal biologic Strattice mesh implantation is associated with significantly more frequent abdominal wall complications requiring re-operation. Therefore, the use of such meshes cannot be recommended in the contaminated environment of emergency abdominal surgery.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01110798.
LEVEL OF EVIDENCE


I; Study type: prospective randomized controlled trial without negative criterion.",2020,"Abdominal wall complications requiring re-operations were more frequent in the mesh group compared to the no mesh group (5 of 13 [83.3%] vs 1 of 13 [14.3%] patients, p=0.026).","['patients undergoing emergency abdominal surgery ', 'patients undergoing emergency abdominal surgery', '48 patients', 'patients undergoing emergency abdominal surgery at Bern University Hospital, Switzerland from April 2016 to March 2019']","['intraperitoneal biologic Strattice mesh implantation', 'intraperitoneal implantation of a biologic Strattice mesh with standard abdominal closure', 'prophylactic implantation of a biological intraperitoneal mesh using Strattice, Allergan (mesh group) or standard abdominal closure using a single, continuous running suture (no mesh group', 'Biologic mesh implantation']",['Abdominal wall complications requiring re-operations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C3253051', 'cui_str': 'strattice'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",48.0,0.158929,"Abdominal wall complications requiring re-operations were more frequent in the mesh group compared to the no mesh group (5 of 13 [83.3%] vs 1 of 13 [14.3%] patients, p=0.026).","[{'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Jakob', 'Affiliation': 'Department of Visceral Surgery and Medicine, University Hospital, Bern, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haltmeier', 'Affiliation': 'Department of Visceral Surgery and Medicine, University Hospital, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Candinas', 'Affiliation': 'Department of Visceral Surgery and Medicine, University Hospital, Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Beldi', 'Affiliation': 'Department of Visceral Surgery and Medicine, University Hospital, Bern, Switzerland.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002877']
2653,32649638,Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk.,"OBJECTIVE


Investigate if changes in objective sleep quality index (SQI) assessed through cardiopulmonary-coupling analysis impacts blood pressure (BP) in patients with obstructive sleep apnea at high-cardiovascular risk.
METHODS


Secondary analysis of ECG and pulse-oximetry-[oxygen saturation (SpO2)] data from the Heart Biomarker Evaluation in Apnea Treatment study, multicenter, controlled trial in patients with cardiovascular disease and moderate-severe obstructive sleep apnea, randomly assigned to intervention of healthy lifestyle and sleep hygiene education (control group), continuous positive airway pressure (CPAP) or nocturnal supplemental oxygen. Participants with good-quality ECG-signal and SpO2-signal (n = 241) were included.
RESULTS


CPAP-therapy significantly improved BP, with net average improvement in mean arterial blood pressure during sleep (MAP) when compared with nocturnal supplemental oxygen-therapy or healthy lifestyle and sleep education-therapy, -3.92 (P = 0.012) and -3.83 (P = 0.016), respectively. When stratified on the basis of baseline-SQI, CPAP-therapy improves MAP -3.13 (P = 0.030) and MAP -5.00 (P = 0.001), in patients with compromised baseline-SQI (SQI < 55). Stratifying the cohort based on changes in SQI during the study period (SQI-SQI), controlling for sex, age over 60, apnea-hypopnea index, SpO2 less than 80%, baseline BP and cardiovascular disease, significant differences are observed comparing the groups that Improved-SQI (SQI < 55, SQI ≥ 55) and Declined-SQI (SQI ≥ 55, SQI < 55) in MAP -4.87 (P = 0.046) and mean diastolic blood pressure (MDP) -4.42 (P = 0.026) as well as MAP -6.36 (P = 0.015), mean systolic blood pressure wake (MSP) -7.80 (P = 0.048) and mean diastolic blood pressure wake (MDP) -5.64 (P = 0.009), respectively. Improved SQI reflects the magnitude of positive effect on BP which is reached mostly through initiation of CPAP-therapy.
CONCLUSION


Cardiopulmonary coupling-derived sleep quality impacted 24-h MAP and MDP, as well as BP during wake, in patients participating in the Heart Biomarker Evaluation in Apnea Treatment-study.",2020,(P = 0.046) and mean diastolic blood pressure (MDP) -4.42,"['patients participating in the Heart Biomarker Evaluation in Apnea Treatment-study', 'Participants with good-quality ECG-signal and SpO2-signal (n\u200a=\u200a241) were included', 'patients with obstructive sleep apnea at high-cardiovascular risk', 'patients with cardiovascular disease and moderate-severe obstructive sleep apnea']","['cardiopulmonary-coupling analysis impacts blood pressure (BP', 'healthy lifestyle and sleep hygiene education (control group), continuous positive airway pressure (CPAP) or nocturnal supplemental oxygen']","['blood pressure', 'mean arterial blood pressure during sleep (MAP', 'ECG and pulse-oximetry-[oxygen saturation (SpO2', 'objective sleep quality index (SQI', 'mean systolic blood pressure wake (MSP', 'mean diastolic blood pressure wake (MDP) -5.64', 'mean diastolic blood pressure (MDP) -4.42', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0026031', 'cui_str': 'Microspectrophotometry'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517762', 'cui_str': '4.42'}]",241.0,0.0331929,(P = 0.046) and mean diastolic blood pressure (MDP) -4.42,"[{'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Magnusdottir', 'Affiliation': 'MyCardio LLC, SleepImage, Denver, Colorado.'}, {'ForeName': 'Hugi', 'Initials': 'H', 'LastName': 'Hilmisson', 'Affiliation': 'MyCardio LLC, SleepImage, Denver, Colorado.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Thomas', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Journal of hypertension,['10.1097/HJH.0000000000002553']
2654,32649708,Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study.,"BACKGROUND


Dietary protein supplementation combined with resistance exercise (RE) may counteract declines in muscle strength, mass, and function (sarcopenia), but the role of whole foods rich in protein, such as milk, is less well understood. In the MIlkMAN study, we aimed to examine the feasibility and acceptability of milk+RE as an intervention for muscle function in community-dwelling older adults, and provide exploratory pilot data for future substantive research in population at risk of sarcopenia.
METHODS


In a parallel groups design, 30 older adults (71.7±3.6 years; 12 women) were randomised into three groups: WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE. RE was performed twice-weekly over 6 weeks in a community gym, followed by the consumption of 500 ml of milk (~20 g protein) or carbohydrate drink immediately after exercise and a further 500 ml at home within the following 4-5 hours. The feasibility and acceptability of the study was determined by calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events.
RESULTS


The response rate was 49% (out of 400 invitations sent), and the recruitment rate was 73.2% (30 participants recruited out of 41 screened for eligibility). Twenty-nine participants completed the intervention-an attendance rate of 97.1%; 89.7% rated their experience as 'excellent'/very good'. Compliance with taking the drinks was 97.1% (WM), 98.3% (SM), and 95.0% (C); 93.1% rated their drink intake as 'easy'/'very easy' with no adverse effects. Collection of exploratory pilot data to inform future trials was successful. Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
CONCLUSIONS


This community-based milk+RE intervention was feasible and acceptable to older adults. The study successfully collected pilot data for future substantive research.",2020,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","['30 older adults (71.7±3.6 years; 12 women', 'older adults', 'community-dwelling older adults', '20', 'community-dwelling older adults (MIlkMAN']","['milk and resistance exercise intervention', 'milk+RE', 'carbohydrate drink', 'WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE', 'Dietary protein supplementation combined with resistance exercise (RE', 'milk+RE intervention']","['attendance rate', 'muscle function', 'Mean change in grip strength, 5-chair rises, and gait speed', ""calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events"", 'response rate', 'Feasibility and acceptability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0402554', 'cui_str': 'Milkman'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0398701,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","[{'ForeName': 'Antoneta', 'Initials': 'A', 'LastName': 'Granic', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hurst', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lorelle', 'Initials': 'L', 'LastName': 'Dismore', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Research and Development, North Tyneside General Hospital, North Shields, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stevenson', 'Affiliation': 'Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Avan A', 'Initials': 'AA', 'LastName': 'Sayer', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Aspray', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235952']
2655,32649717,Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.,"OBJECTIVE


Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting.
METHODS


We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 ""none"" to 10 ""worst pain""). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group).
RESULTS


At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
CONCLUSIONS


Two of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02459964.",2020,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","['cancer patients with severe pain in an emergency department (ED) setting', 'patients with cancer in the emergency department setting', '82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40']","['INF relative to IVH', 'Intranasal fentanyl spray versus intravenous opioids', 'Intranasal fentanyl (INF', 'hydromorphone (IVH']","['maximum pain at T0 and that T0 pain', 'T0 pain ratings', 'mean pain decrease', 'mean pain change', 'mean log-transformed pain ratings', '2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group', 'severe pain', 'pain change']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",82.0,0.173866,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Banala', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Osama K', 'Initials': 'OK', 'LastName': 'Khattab', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Valda D', 'Initials': 'VD', 'LastName': 'Page', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Carla L', 'Initials': 'CL', 'LastName': 'Warneke', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Knox H', 'Initials': 'KH', 'LastName': 'Todd', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Sai-Ching Jim', 'Initials': 'SJ', 'LastName': 'Yeung', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}]",PloS one,['10.1371/journal.pone.0235461']
2656,32649733,An exploratory Study of EEG Alpha Oscillation and Pupil Dilation in Hearing-Aid Users During Effortful listening to Continuous Speech.,"Individuals with hearing loss allocate cognitive resources to comprehend noisy speech in everyday life scenarios. Such a scenario could be when they are exposed to ongoing speech and need to sustain their attention for a rather long period of time, which requires listening effort. Two well-established physiological methods that have been found to be sensitive to identify changes in listening effort are pupillometry and electroencephalography (EEG). However, these measurements have been used mainly for momentary, evoked or episodic effort. The aim of this study was to investigate how sustained effort manifests in pupillometry and EEG, using continuous speech with varying signal-to-noise ratio (SNR). Eight hearing-aid users participated in this exploratory study and performed a continuous speech-in-noise task. The speech material consisted of 30-second continuous streams that were presented from loudspeakers to the right and left side of the listener (±30° azimuth) in the presence of 4-talker background noise (+180° azimuth). The participants were instructed to attend either to the right or left speaker and ignore the other in a randomized order with two different SNR conditions: 0 dB and -5 dB (the difference between the target and the competing talker). The effects of SNR on listening effort were explored objectively using pupillometry and EEG. The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition. This study demonstrates that both measures are sensitive to changes in SNR during continuous speech.",2020,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"['Eight hearing-aid users participated', 'Hearing-Aid Users', 'Individuals with hearing loss allocate cognitive resources']","['EEG Alpha Oscillation and Pupil Dilation', 'continuous speech-in-noise task', 'SNR', 'continuous speech with varying signal-to-noise ratio (SNR']",['mean pupil dilation and decreased EEG alpha power'],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0156161,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"[{'ForeName': 'Tirdad', 'Initials': 'T', 'LastName': 'Seifi Ala', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Alickovic', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Whitmer', 'Affiliation': 'Hearing Sciences-Scottish Section, Division of Clinical Neuroscience, University of Nottingham, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lunner', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}]",PloS one,['10.1371/journal.pone.0235782']
2657,32649896,Flapless Piezotome Crest Split Achieves Comparable Outcomes to Autologous Onlay Grafts With Significant Less Patient Morbidity and Complications-A Randomized Clinical Study.,"PURPOSE


In the management of the narrow alveolar ridge, the flapless piezotome crest split (FPCS) technique with horizontal distraction was introduced as an alternative to lateral alveolar ridge augmentation using autologous bone block grafting (ABBG). The study purpose was to measure and compare the alveolar crest width and complications between FPCS and ABBG.
MATERIALS AND METHODS


We implemented a nonblinded, randomized clinical trial. The sample included patients requiring lateral alveolar ridge augmentation before implant insertion. The predictor variable was lateral alveolar ridge augmentation performed using ABBG (control group) or FPCS using an ultrasonic surgical device (Piezotome II or Piezotome CUBE; Acteon, Norwich, UK) and specific crest split working tips (test group). The primary outcome variable was the overall coronal crest width achieved after completed healing measured at 6 months using 3-dimensional imaging studies. Other study variables included the postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration. Descriptive and bivariate statistics were computed using SPSS, version 22.0 (IBM Corp, Armonk, NY), and P ≤ .05 was considered to indicate statistical significance.
RESULTS


The sample included 567 patients treated with ABBG (56.1% female; age, 64.1 ± 20.2 years) and 562 treated with FPCS (57.2% female; age, 62.3 ± 18.2 years). The baseline crest width in the control and test groups was 2.1 ± 0.5 mm and 1.9 ± 0.4 mm, respectively. The final crest width achieved with ABBG and FPCS was 5.8 ± 0.8 mm and 6.5 ± 0.7 mm, respectively (P > .05). Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
CONCLUSIONS


FPCS seems to be a significantly less traumatic alternative to buccal onlay grafting with autologous bone blocks, providing a comparable or better net gain in the alveolar crest width with a significantly shorter operative time and less postoperative morbidity.",2020,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","['567 patients treated with ABBG (56.1% female; age, 64.1\xa0±\xa020.2\xa0years) and 562 treated with FPCS (57.2% female; age, 62.3\xa0±\xa018.2\xa0years', 'patients requiring lateral alveolar ridge augmentation before implant insertion']","['Flapless Piezotome Crest Split', 'ABBG (control group) or FPCS', 'ultrasonic surgical device (Piezotome II or Piezotome CUBE', 'Autologous Onlay Grafts']","['postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration', 'final crest width achieved with ABBG and FPCS', 'postoperative complication rate, morbidity, and operative time', 'alveolar crest width and complications', 'postoperative morbidity', 'baseline crest width', 'overall coronal crest width achieved after completed healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002387', 'cui_str': 'Augmentation of alveolar ridge'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",567.0,0.067806,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","[{'ForeName': 'Ziad Tarek', 'Initials': 'ZT', 'LastName': 'Mahmoud', 'Affiliation': 'Lecturer, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Egypt. Electronic address: drziadtmahmoud@gmail.com.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wainwright', 'Affiliation': 'Visiting Professor, Faculty of Dentistry, University of Seville, Seville, Spain.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Troedhan', 'Affiliation': 'Visiting Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt; and Visiting Professor, Institute for Oral and Maxillofacial Surgery and Dentistry, General Hospital ""Krankenhaus Hietzing"" of the City of Vienna, Vienna, Austria.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.008']
2658,32649925,"Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.","BACKGROUND


Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis.
METHODS


We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433.
FINDINGS


Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial.
INTERPRETATION


This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.
FUNDING


National Institute for Health Research.",2020,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","['101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to', 'young people with first-episode psychosis', 'adolescents with first-episode psychosis (MAPS', 'participants from seven UK National Health Service Trust sites', 'adolescents with first-episode psychosis', 'Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service', 'The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups', 'early-onset psychosis']","['CBT', 'antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention', 'antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT', 'antipsychotic monotherapy', 'Antipsychotic medication versus psychological intervention', 'antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention', 'antipsychotics plus psychological intervention']","['feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS', 'serious adverse events', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0011251', 'cui_str': 'Delusional disorder'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.11201,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK. Electronic address: anthony.p.morrison@manchester.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': ""Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK; Institute for Mental Health and Centre for Human Brain Health, School of Psychology, University of Birmingham, Birmingham, UK; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK; Early Intervention in Psychosis Service, Lancashire and South Cumbria NHS Foundation Trust, Chorley, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30248-0']
2659,32649961,The effect of platelet-rich plasma on female androgenetic alopecia: a randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) may be a useful treatment for androgenetic alopecia (AGA), although objective studies are needed.
OBJECTIVE


To determine whether PRP injections improve female AGA.
METHOD


Prospective, randomized controlled trial of 30 females diagnosed with AGA. Patients received subdermal scalp injections of Eclipse system PRP or placebo saline at weeks 0, 4 and 8. Outcome measures were changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment (improved or not improved) at week 24.
RESULTS


Blinded global photographic assessment indicated that 57% of PRP patients vs. 7% of saline patients improved at week 24 from baseline (p<0.01). Compared to baseline, there was improvement in mean density in the PRP group vs. the placebo group at week 8 (+71.1 vs. -26.7 hairs/cm 2 , p<0.01) and week 24 (+105.9 vs. -52.4 hairs/cm 2 , p<0.01). Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01). Adverse effects included headache, scalp tightness, swelling, redness, and post-injection bleeding.
LIMITATIONS


Two patients lost to follow-up.
CONCLUSION


PRP with the Eclipse system is a safe and effective intervention for female AGA.",2020,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","['30 females diagnosed with AGA', 'female androgenetic alopecia', 'androgenetic alopecia (AGA']","['subdermal scalp injections of Eclipse system PRP or placebo saline', 'PRP injections', 'platelet-rich plasma', 'placebo']","['mean caliber', 'headache, scalp tightness, swelling, redness, and post-injection bleeding', 'mean density', 'changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.356908,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028. Electronic address: DPDubin121@gmail.com.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028.'}, {'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Leight', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Farberg', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028; Arkansas Dermatology, 9601 Baptist Health Drive, Suite 1070, Little Rock, AR 72205.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Torbeck', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Burton', 'Affiliation': 'Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Khorasani', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85(th) Street, 5(th) Floor, New York, NY 10028.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.1021']
2660,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N=288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'David Strain', 'Affiliation': 'of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Maria Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
2661,32650223,Skin carotenoids are inversely associated with adiposity in breast cancer survivors.,"Carotenoids are antioxidants which may mitigate some of the adverse effects of obesity, a condition associated with poor outcomes in breast cancer patients. We hypothesized that baseline skin carotenoids would be inversely associated with adiposity in breast cancer survivors and would increase with weight loss. Skin carotenoid score (SCS) was assessed by resonance Raman spectroscopy in breast cancer survivors (body mass index ≥25 kg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n = 47). Measurements included total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers. Associations between SCS, adiposity measures, and serum biomarkers were assessed at baseline, as was the change in SCS from baseline to 6 months, in the intervention and usual care groups. At baseline, SCS was inversely correlated with all adiposity measures (P ≤ .05). In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20). Baseline SCS was significantly inversely associated with log C-reactive protein levels (regression coefficient β ± SE: -0.051± 0.019; P = .011) and log leptin (β ± SE: -0.019± 0.009; P = .046), but the associations were no longer significant after adjustment for adiposity. Over the 6-month study, the intervention group had a 17.6% increase in SCS compared to a 1.5% decrease in the usual care group (P = .28). In our study of overweight and obese breast cancer survivors, dual-energy X-ray absorptiometry-measured body fat explained a large portion of the variation in skin carotenoids at baseline, suggesting a stronger association than that previously seen in studies using less accurate measures of adiposity.",2020,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","['breast cancer patients', 'breast cancer survivors', 'overweight and obese breast cancer survivors', 'breast cancer survivors (body mass index ≥25\u202fkg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n\u202f=\u202f47']",[],"['Skin carotenoid score (SCS', 'log C-reactive protein levels', 'SCS', 'SCS, adiposity measures, and serum biomarkers', 'weight loss', 'adiposity measures', 'total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0209892,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: brenda.cartmel@yale.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: chelsea.anderson@cancer.org.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: melinda.irwin@yale.edu.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: maura.harrigan@yale.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale Cancer Center, PO Box 208028, New Haven, CT 06519; Yale School of Medicine, 333 Cedar St, New Haven, CT 06511. Electronic address: tara.sanft@yale.edu.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: fangyong.li@yale.edu.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Gellermann', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: werner@longevitylinkcorporation.com.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Ermakov', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: igor@longevitylinkcorporation.com.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: leah.ferrucci@yale.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.012']
2662,32650231,Race and cultural factors in an RCT of prolonged exposure and sertraline for PTSD.,"The efficacy of treatments for posttraumatic stress disorder (PTSD) among African Americans is less clear given underrepresentation in clinical research. Additionally, intervention research examining race has typically not considered within-group heterogeneity, such as acculturation, ethnic identity, and cultural attitudes. In a randomized controlled trial, African American (n = 43) and Caucasian (n = 130) individuals received prolonged exposure (PE) or sertraline for PTSD, comparing: treatment response, retention, and treatment beliefs and preferences. Indirect effects of cultural variables were also examined. African Americans reported stronger ethnic identity (d = 0.71), less positive attitudes toward other groups (d = 0.36), and less acculturation (d = 0.51) than Caucasians. Noninferiority analyses indicated clinically equivalent PTSD outcomes for African Americans and Caucasians in both treatments. Groups showed comparable improvements in depression and functioning, and similar treatment preferences and beliefs. African Americans attended fewer sessions in PE (d = 0.87) and sertraline (d = 0.53) than Caucasians. Indirect effects analyses indicated positive cultural attitudes toward other ethnoracial groups were consistently associated with better treatment outcome and retention. Despite no differential effectiveness, findings may highlight the need to target retention among African Americans. Within-group cultural aspects of race may be an informative complement to basic, categorical conceptualizations.",2020,Indirect effects analyses indicated positive cultural attitudes toward other ethnoracial groups were consistently associated with better treatment outcome and retention.,"['African Americans', 'posttraumatic stress disorder (PTSD) among African Americans', 'African American (n\xa0=\xa043) and Caucasian (n\xa0=\xa0130) individuals received']","['prolonged exposure (PE) or sertraline', 'sertraline']","['depression and functioning, and similar treatment preferences and beliefs', 'positive attitudes', 'positive cultural attitudes']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",130.0,0.0210524,Indirect effects analyses indicated positive cultural attitudes toward other ethnoracial groups were consistently associated with better treatment outcome and retention.,"[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: alexander.kline@va.gov.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103690']
2663,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
2664,32650345,Adding efficiency to proficiency: a study of trainee polypectomy efficiency metrics.,"BACKGROUND


Although validated colonoscopy assessment tools exist, they do not measure efficiency. This study aimed to assess content validity of polypectomy efficiency (PE) and neoplastic polypectomy efficiency (NPE) as colonoscopy efficiency indices.
METHODS


Data from a randomized controlled trial evaluating polypectomy among gastroenterology trainees were utilized. PE and NPE were defined as number of polyps (or neoplastic polyps) removed/withdrawal time × 100. Content validity was assessed by determining the association between efficiency indices and polypectomy times.
RESULTS


20 trainees performed 601 colonoscopies. There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48 ( P  = 0.001) and NPE decreased by 0.24 ( P  = 0.03).
CONCLUSIONS


The study proposed and provided content validity for PE and NPE as colonoscopy efficiency indices.",2020,"There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48",['20 trainees performed 601 colonoscopies'],"['polypectomy', 'polypectomy efficiency (PE) and neoplastic polypectomy efficiency (NPE']","['number of polyps (or neoplastic polyps) removed/withdrawal time', 'Content validity', 'NPE', 'polypectomy time', 'PE']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0538042,"There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Muething', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Wani', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""Biostatistics, Children's Hospital Association, Kansas City, Kansas, United States.""}, {'ForeName': 'Violette', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Ezenwanyi', 'Initials': 'E', 'LastName': 'Ezekwe', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Nguyen-Vu', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Malvar', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Duloy', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Kaltenbach', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Keswani', 'Affiliation': 'Gastroenterology, Northwestern University, Chicago, Illinois, United States.'}, {'ForeName': 'Swati G', 'Initials': 'SG', 'LastName': 'Patel', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}]",Endoscopy,['10.1055/a-1192-4250']
2665,32348303,"Exploring young women's reproductive decision-making, agency and social norms in South African informal settlements.","This paper explores reproductive decision-making among young women in South Africa's informal settlements and considers whether and how agency and social norm theory inform their decisions. Understanding whether, when and how young women make decisions about conception and motherhood is critical for supporting women to avoid unplanned, early motherhood. Qualitative data were collected from 15 young women in informal settlements in eThekwini, South Africa at three time points over 18 months, using in-depth interviews, participant observation and photovoice, and were analysed inductively. When the young women were teenagers and into their early twenties, and had not yet had a child, most paid little attention to whether or not they conceived. This shifted as they grew older and/or after having a first child, at which point many of the women began to express, and sometimes act upon, a greater desire to control whether and when they conceived and delay further pregnancies. At different times in their lives, both social norms and reproductive agency, specifically 'distributed agency' played significant roles in influencing their reproductive decision-making. Social norms held the most influence when they were teenagers and experiencing normative pressures to have a baby while young. As they grew older and/or had a first child they began to assert some agentic control around their reproduction. We therefore recommend that in order to improve the effectiveness of services and interventions supporting young women to delay unplanned pregnancies, programmers, researchers and policy makers must develop a better understanding of the role of social norms and agency at different stages of women's lives.",2020,"At different times in their lives, both social norms and reproductive agency, specifically 'distributed agency' played significant roles in influencing their reproductive decision-making.","['15 young women in informal settlements in eThekwini, South Africa at three time points over 18 months, using in-depth interviews, participant observation and photovoice, and were analysed inductively', ""young women in South Africa's informal settlements""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]",[],[],15.0,0.0253601,"At different times in their lives, both social norms and reproductive agency, specifically 'distributed agency' played significant roles in influencing their reproductive decision-making.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}]",PloS one,['10.1371/journal.pone.0231181']
2666,30784040,Cross-Sectional Evaluation of the Psychometric Properties of the Headache-Specific Locus of Control Scale in People With Migraine.,"OBJECTIVE


This study aims to investigate the psychometric properties (component structure, reliability, and construct validity) of the Headache-Specific Locus of Control scale in several clinical migraine populations.
BACKGROUND


Headache-specific locus of control beliefs may impact a person's behavioral decisions that affect the likelihood of migraine attack onset, emotional responses to migraine attacks, coping strategies used, and treatment adherence. The 33-item Headache-Specific Locus of Control scale is the most widely used measure of locus of control specific to headache yet psychometric evaluations remain limited.
METHODS


Six hundred and ninety-five adults with a diagnosis of migraine from 5 different research studies completed cross-sectional self-report measures including the Headache-Specific Locus of Control scale and measures of quality of life and disability (Migraine-Specific Quality of Life Questionnaire and Migraine Disability Assessment).
RESULTS


Five Headache-Specific Locus of Control components emerged from Horn's Parallel Analysis, Minimum Average Partial test, and Principal Component Analysis (eigenvalues: Presence of Internal = 5.7, Lack of Internal = 4.0, Luck = 2.9, Doctor = 2.0, and Treatment = 1.5). The 33 Headache-Specific Locus of Control items demonstrated adequate internal consistency for total (α = 0.79) and subscale scores (α's = 0.69 to 0.88). This study found preliminary evidence of convergent validity. For example, Lack of Internal (r = -0.12, P = 0.004), Doctor (r = -0.20, P < .001), and Treatment (r = -0.12, P = .004) beliefs were associated with higher overall migraine-specific quality of life impairments.
CONCLUSIONS


The Headache-Specific Locus of Control scale is a reliable and valid measure of headache-specific locus of control. Findings suggest that headache-specific locus of control is more multidimensional than previous conceptualizations and contribute to our understanding of control beliefs as a potential mechanism for migraine treatment.",2019,"beliefs were associated with higher overall migraine-specific quality of life impairments.
","['Six hundred and ninety-five adults with a diagnosis of migraine from 5 different research studies completed cross-sectional self-report measures including the', 'People With Migraine']",[],"['Headache-Specific Locus of Control scale and measures of quality of life and disability (Migraine-Specific Quality of Life Questionnaire and Migraine Disability Assessment', 'subscale scores', 'overall migraine-specific quality of life impairments']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",695.0,0.0182042,"beliefs were associated with higher overall migraine-specific quality of life impairments.
","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Grinberg', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Seng', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}]",Headache,['10.1111/head.13485']
2667,30861580,Psychometric Validation of the Role Function Restrictive Domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 Electronic Patient-Reported Outcome in Patients With Episodic and Chronic Migraine.,"OBJECTIVES


To assess the measurement properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain to evaluate the functional impact of migraine in patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials.
METHODS


The 7-item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n = 851] and CGAH [n = 909]) and 1 CM (CGAI [n = 1090]) Phase 3 galcanezumab clinical trials. Anchor- and distribution-based analyses were utilized to derive a responder threshold for clinical interpretation of change over time. The Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and migraine headache days (MHD) served as anchors. Responsiveness and responder threshold analyses were completed from baseline to the average of months 4-6 for EM studies, and from baseline to month 3 for the CM study; timeframes selected were based on the primary endpoints in these studies.
RESULTS


Cronbach's alpha values for internal consistency reliability were 0.93, 0.92, and 0.92, for CGAG, CGAH, and CGAI, respectively. Test-retest reliability intra-class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients. Convergent validity was supported by moderate to strong correlations (≥0.30) between the RFR and both MIDAS and PGI-S. Known-groups validity was established between subgroups stratified by baseline PGI-S and MHD (P < .05; δ = 0.35-1.96). For the EM studies, anchor variables suggested a change of ≥25 points (equivalent to 9 points/state changes on raw scale) in the RFR was an appropriate threshold to interpret a treatment benefit. For the CM study a change of ≥17.14 points (6 points/state changes on raw scale) was an appropriate threshold. In all 3 studies, significantly (P < .01) more galcanezumab patients achieved the responder definition thresholds, as compared to placebo (odds ratios of 1.98, 2.45, 2.27, 2.44, 1.64, and 1.66 for the 120 and 240 mg arms in the CGAG, CGAH, and CGAI trials, respectively).
CONCLUSION


The MSQv2.1 ePRO RFR has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in EM and CM clinical trials to assess the functional impact of migraine.",2019,"In all 3 studies, significantly (P < .01)","['patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials', 'Patients With Episodic and Chronic Migraine']","['Life Questionnaire version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR', 'placebo']","['Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and migraine headache days (MHD', 'Test-retest reliability intra-class correlation coefficients', 'relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy', 'internal consistency reliability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720882', 'cui_str': 'Patient global impression of severity'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",,0.0745388,"In all 3 studies, significantly (P < .01)","[{'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Speck', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Shalhoub', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Kathleen W', 'Initials': 'KW', 'LastName': 'Wyrwich', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Bush', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Headache,['10.1111/head.13497']
2668,30945431,"Renal effects of a sodium-glucose cotransporter 2 inhibitor, tofogliflozin, in relation to sodium intake and glycaemic status.","AIMS


Little is known about whether sodium intake is associated with the clinical effects of SGLT2 inhibitors (SGLT2is); however, SGLT2is may increase urinary sodium excretion. Thus, we investigated the impact of daily sodium intake on the estimated glomerular filtration rate (eGFR) via an SGLT2i, tofogliflozin (TOFO), in patients with type 2 diabetes (T2D).
METHODS


Individual-level data on 775 T2D patients in TOFO Phase 3 trials were analysed. Adjusted changes in variables during 52 weeks of TOFO therapy were compared according to basal daily salt intake (DSI), which was measured based on estimated daily urinary sodium excretion using the Tanaka formula. Multivariable analysis was used to investigate the impact of basal DSI on changes in eGFR at Weeks 4 and 52.
RESULTS


Sixty-six percent of participants were men; mean age, HbA1c, body mass index, eGFR MDRD  and median DSI were 58.5 years, 8.0%, 25.6 kg/m 2  , 83.9 mL/min/1.73 m 2  and 9.3 g/d, respectively. In all participants, eGFR MDRD  sharply dipped during Week 4, and gradually increased by Week 52, showing a significant increase overall from baseline to Week 52. Multivariable analysis showed that basal DSI and HbA1c levels were independently correlated with eGFR MDRD  changes at Weeks 4 and 52. Additionally, lower baseline HbA1c and DSI levels were significantly correlated with a greater increase in eGFR MDRD  at Week 52.
CONCLUSIONS


Dietary salt intake, in addition to glycaemic control, correlates with changed eGFR MDRD  via TOFO. Thus, an appropriate dietary approach to therapy should be considered before treatment of T2D patients with an SGLT2i.",2019,"In all participants, eGFR MDRD  sharply dipped during Week 4, and gradually increased by Week 52, showing a significant increase overall from baseline to Week 52.","['Sixty-six percent of participants were men; mean age, HbA1c, body mass index, eGFR MDRD  and median DSI were 58.5\u2009years, 8.0%, 25.6', 'Individual-level data on 775', 'T2D patients with an SGLT2i', 'patients with type 2 diabetes (T2D']","['sodium-glucose cotransporter 2 inhibitor, tofogliflozin']","['urinary sodium excretion', 'eGFR MDRD', 'lower baseline HbA1c and DSI levels', 'glomerular filtration rate (eGFR) via an SGLT2i, tofogliflozin (TOFO', 'eGFR MDRD  sharply dipped', 'basal DSI and HbA1c levels']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]",775.0,0.0565084,"In all participants, eGFR MDRD  sharply dipped during Week 4, and gradually increased by Week 52, showing a significant increase overall from baseline to Week 52.","[{'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Nunoi', 'Affiliation': ""Division of Endocrinology and Metabolism, St. Mary's Hospital, Fukuoka, Japan.""}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': ""Division of Endocrinology and Metabolism, St. Mary's Hospital, Fukuoka, Japan.""}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of General Internal Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Medical Information and Product Advancement Department, Kowa Pharmaceutical Company, Ltd., Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Department, Kowa Company, Ltd., Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13731']
2669,30979610,Effects of hyperhomocysteinaemia and metabolic syndrome on reproduction in women with polycystic ovary syndrome: a secondary analysis.,"RESEARCH QUESTION


What is the association between hyperhomocysteinaemia (HHCY), metabolic syndrome, and reproductive outcomes among women with polycystic ovary syndrome (PCOS).
DESIGN


A secondary analysis of PCOSAct with 21 sites in China. A total of 1000 women with PCOS were enrolled; 936 women with baseline homocysteine (HCY) were analysed.
RESULTS


Higher HCY was associated with higher body mass index, free testosterone and lower FSH, fasting glucose (P < 0.001; P < 0.001; P = 0.005; P < 0.001) and ovulation rate among all participants (OR 0.59, 95% CI 0.41 to 0.86; OR 0.57, 95% CI 0.39 to 0.83 tertiles 2 and 3 versus tertile 1, respectively). The HHCY group had lower oestradiol and higher free testosterone (P = 0.04; P < 0.001) than the controls. In the metabolic syndrome group, LH, LH-FSH ratio and sex hormone-binding globulin were lowest in the metabolic syndrome group (all P < 0.001). In the HHCY group, ovulation rate decreased and the second or third trimester pregnancy loss rate increased compared with controls (OR 1.678, 95% CI 1.04 to 2.70; OR 0.03, 95% CI 0.00 to 0.42) with treatment adjustment. Compared with the controls, ovulation, conception, pregnancy, second or third trimester pregnancy loss and live birth rates were statistically lower in the metabolic syndrome group after adjusting treatment (OR 1.76, 95% CI 1.15 to 2.70; OR 1.75, 95% CI 1.15 to 2.65; OR 2.09, 95% CI 1.27 to 3.44; OR 0.02, 95% CI 0.00 to 0.33; OR 2.42 95% CI 1.42 to 4.10), and pregnancy, pregnancy loss and live birth rates remained significantly different after adjusting for treatment and sex-hormone factors (OR 1.77, 95% CI 1.05 to 2.99; OR 0.14, 95% CI 0.02 to 0.82; OR 2.02, 95% CI 1.16 to 3.50).
CONCLUSIONS


In women with PCOS, HHCY contributes to increased pregnancy loss and reduced ovulation, and metabolic syndrome was related to defects in ovulation, conception, pregnancy, pregnancy loss and live birth, indicating that the two conditions lead to defects at various reproductive stages.",2019,"Compared with the controls, ovulation, conception, pregnancy, second or third trimester pregnancy loss and live birth rates were statistically lower in the metabolic syndrome group after adjusting treatment (OR 1.76, 95% CI 1.15 to 2.70; OR 1.75, 95% CI 1.15 to 2.65; OR 2.09, 95% CI 1.27 to 3.44; OR 0.02, 95% CI 0.00 to 0.33; OR 2.42 95% CI 1.42 to 4.10), and pregnancy, pregnancy loss and live birth rates remained significantly different after adjusting for treatment and sex-hormone factors (OR 1.77, 95% CI 1.05 to 2.99; OR 0.14, 95% CI 0.02 to 0.82; OR 2.02, 95% CI 1.16 to 3.50).
","['PCOSAct with 21 sites in China', 'women with polycystic ovary syndrome (PCOS', '1000 women with PCOS were enrolled; 936 women with baseline homocysteine (HCY) were analysed', 'women with polycystic ovary syndrome']",['hyperhomocysteinaemia and metabolic syndrome'],"['ovulation rate', 'ovulation, conception, pregnancy, second or third trimester pregnancy loss and live birth rates', 'ovulation, conception, pregnancy, pregnancy loss and live birth', 'lower oestradiol and higher free testosterone', 'LH, LH-FSH ratio and sex hormone-binding globulin', 'higher body mass index, free testosterone and lower FSH, fasting glucose', 'pregnancy, pregnancy loss and live birth rates', 'trimester pregnancy loss rate', 'pregnancy loss and reduced ovulation, and metabolic syndrome']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]","[{'cui': 'C0598608', 'cui_str': 'Hyperhomocysteinemia'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0860850', 'cui_str': 'Oestradiol decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",1000.0,0.215569,"Compared with the controls, ovulation, conception, pregnancy, second or third trimester pregnancy loss and live birth rates were statistically lower in the metabolic syndrome group after adjusting treatment (OR 1.76, 95% CI 1.15 to 2.70; OR 1.75, 95% CI 1.15 to 2.65; OR 2.09, 95% CI 1.27 to 3.44; OR 0.02, 95% CI 0.00 to 0.33; OR 2.42 95% CI 1.42 to 4.10), and pregnancy, pregnancy loss and live birth rates remained significantly different after adjusting for treatment and sex-hormone factors (OR 1.77, 95% CI 1.05 to 2.99; OR 0.14, 95% CI 0.02 to 0.82; OR 2.02, 95% CI 1.16 to 3.50).
","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China; Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Liangzhen', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Ge', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Duojia', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yuehui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Stener-Victorin', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ernest Hy', 'Initials': 'EH', 'LastName': 'Ng', 'Affiliation': 'The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China. Electronic address: xiaokewu2002@vip.sina.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2018.12.046']
2670,32649327,Cone-Beam CT Image Guidance With and Without Electromagnetic Navigation Bronchoscopy for Biopsy of Peripheral Pulmonary Lesions.,"BACKGROUND


Bronchoscopic diagnosis of small peripheral lung lesions suspected of lung cancer remains a challenge. A successful endobronchial diagnosis comprises navigation, confirmation, and tissue acquisition. In all steps, 3-dimensional information is essential. Cone-beam computed tomography (CBCT) imaging can provide computed tomography information and 3-dimensional augmented fluoroscopy imaging. We assessed whether CBCT imaging can improve navigation and diagnosis of peripheral lesions by 2 clinical workflows with a cross-over design: (1) a primary CBCT and radial endobronchial ultrasound mini probe imaging-based approach and (2) a primary electromagnetic navigation (EMN) and radial endobronchial ultrasound mini probe imaging-based approach.
METHODS


All patients with a peripheral lung lesion biopsy indication were eligible for study inclusion and randomly assigned to study arms. Commercially available equipment was used. The main study goals were to assess CBCT-confirmed navigation success and diagnostic accuracy. Surgery or unambiguous clinical follow-up served as the gold standard.
RESULTS


Eighty-seven patients with 107 lesions were included. Lesion mean longest axis size in the CBCT arm was 16.6 mm (n=47) and 14.2 mm in the EMN arm (n=40). The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively. Addition of EMN to the CBCT approach increased navigation success to 89.9%. Addition of CBCT imaging to the EMN approach significantly increased navigation success to 87.5% per lesion. The overall diagnostic accuracy per patient was significantly lower than the navigation success, being 72.4%.
CONCLUSION


CBCT imaging is a valuable addition to navigation bronchoscopy. Although overall navigation success was high, the diagnostic accuracy remains to be improved. Future research should focus on improving the tissue acquisition methodology.",2020,"The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively.","['All patients with a peripheral lung lesion biopsy indication', 'Eighty-seven patients with 107 lesions were included']","['Electromagnetic Navigation Bronchoscopy', 'EMN', 'CBCT imaging', 'Cone-Beam CT Image Guidance', 'Cone-beam computed tomography (CBCT) imaging', 'CBCT', 'radial endobronchial ultrasound mini probe imaging-based approach and (2) a primary electromagnetic navigation (EMN) and radial endobronchial ultrasound mini probe imaging-based approach']","['overall navigation success', 'overall diagnostic accuracy', 'navigation success', 'CBCT-confirmed navigation success and diagnostic accuracy', 'Lesion mean longest axis size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3899273', 'cui_str': 'Electromagnetic navigation bronchoscopy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",87.0,0.0827166,"The primary CBCT approach and primary EMN approach had 76.3% and 52.2% navigation success, respectively.","[{'ForeName': 'Roel L J', 'Initials': 'RLJ', 'LastName': 'Verhoeven', 'Affiliation': 'Departments of Pulmonology.'}, {'ForeName': 'Jurgen J', 'Initials': 'JJ', 'LastName': 'Fütterer', 'Affiliation': 'Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Hoefsloot', 'Affiliation': 'Departments of Pulmonology.'}, {'ForeName': 'Erik H F M', 'Initials': 'EHFM', 'LastName': 'van der Heijden', 'Affiliation': 'Departments of Pulmonology.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000697']
2671,32649365,"Oral Alanyl-Glutamine for Inflammation, Nutrition, & Enteropathy: A Randomized Dose-Response Controlled Trial in Children.","OBJECTIVE


Determine the minimum dosage of alanyl-glutamine (Ala-Gln) required to improve gut integrity and growth in children at risk of environmental enteropathy (EE).
METHODS


This was a double-blinded randomized placebo-controlled dose-response trial. We enrolled 140 children residing in a low-income community in Fortaleza, Brazil. Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1. We randomized children to 10 days of nutritional supplementation: Ala-Gln at 3 g/day, Ala-Gln at 6 g/day, Ala-Gln at 12 g/day, or an isonitrogenous dose of glycine (Gly) placebo at 12.5 g/day. Our primary outcome was urinary lactulose-mannitol excretion testing. Secondary outcomes were anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy).
RESULTS


Of 140 children, 103 completed 120 days of follow up (24% dropout). In the group receiving the highest dose of Ala-Gln, we detected a modest improvement in urinary lactulose excretion from 0.19% on day 1 to 0.17% on day 10 (p = 0.05). We observed significant but transient improvements in WHZ at day 10 in two Ala-Gln groups, and in WHZ and WAZ in all Ala-Gln groups at day 30. We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose Ala-Gln promotes short-term improvement in gut integrity and ponderal growth in children at risk of EE. Lower doses produced improvements in ponderal growth in the absence of enhanced gut integrity.",2020,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","['140 children residing in a low-income community in Fortaleza, Brazil', 'children at risk of EE', 'Of 140 children, 103 completed 120 days of follow up (24% dropout', 'Children', 'children at risk of environmental enteropathy (EE', 'Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1', 'participants receiving Ala-Gln.\nCONCLUSIONS\n\n\nIntermediate dose']","['alanyl-glutamine (Ala-Gln', 'Oral Alanyl-Glutamine', 'glycine (Gly) placebo', 'nutritional supplementation: Ala-Gln at 3\u200ag/day, Ala-Gln at 6\u200ag/day, Ala-Gln', 'placebo']","['anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy', 'gut integrity and ponderal growth', 'fecal energy and fecal lactoferrin', 'urinary lactulose-mannitol excretion testing', 'Inflammation, Nutrition, & Enteropathy', 'urinary lactulose excretion', 'fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.28784,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Moore', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Quinn', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Maier', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Guedes', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Josiane S', 'Initials': 'JS', 'LastName': 'Quetz', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramprasad', 'Affiliation': 'Department of Internal Medicine, NYU School of Medicine/NYU Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Gabriela M L Lanzarini', 'Initials': 'GMLL', 'LastName': 'Lopes', 'Affiliation': 'Department of Emergency Medicine, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, and Girona Biomedical Research Institute (IDIBGI), 17007 Girona, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swann', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'José Q', 'Initials': 'JQ', 'LastName': 'Filho', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Junior', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Havt', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Noelia L', 'Initials': 'NL', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Disease and International Health, Department of Medicine, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Aldo A M', 'Initials': 'AAM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002834']
2672,32649388,Contact Lens Discomfort Management: Outcomes of Common Interventions.,"PURPOSE


To assess the consecutive implementation of habitual contact lens discomfort (CLD) management strategies: lid hygiene, daily disposable CL (DDCL) fitting, and artificial tear (AT) supplementation.
METHODS


Contact lens (CL) wearers with CLD symptoms (CLDEQ-8 ≥12 points) were included in the study. Subjects with Meibomian gland dysfunction (MGD) were instructed to perform lid hygiene. All participants were fitted with a DDCL (delefilcon A) and evaluated 1 month later. After, half of them were randomly assigned to use AT (Povidone-2%) at least three times/day, and all participants were evaluated 1 month later. Tests performed were: lower tear meniscus area (LTMA), bulbar, limbal, and tarsal hyperemia, noninvasive tear break-up time (NITBUT), and corneal and conjunctival staining. Weighted combined clinical scores (CS) were created to analyze signs. Changes in symptoms (CLDEQ-8) and CS were analyzed using linear mixed models.
RESULTS


Forty-two subjects (mean age: 23.2±4.9 years) completed the study. Two CS were created, CS 1 was composed of bulbar, limbal, and tarsal hyperemia and corneal staining, and CS 2 by NITBUT, LTMA, and conjunctival staining. CLDEQ-8 was reduced after lid hygiene (mean: -2.73±2.13; P=0.012) and DDCL use (mean: -10.1±3.54; P<0.01), but not after AT use (P=0.62). CS 1 did not change after any intervention. CS-2 was higher (P=0.04) in DGM subjects after lid hygiene, it decreased (P=0.04) after DDCL use.
CONCLUSIONS


Lid hygiene is effective for reducing CLD symptoms in MGD patients. Refitting subjects with delefilcon A is an effective intervention for CLD to reduce symptoms and achieve a healthier ocular surface. Simultaneous administration of AT did not further improve CLD.",2020,"CS-2 was higher (P=0.04) in DGM subjects after lid hygiene, it decreased (P=0.04) after DDCL use.
","['Forty-two subjects (mean age: 23.2±4.9 years) completed the study', 'MGD patients', 'Contact lens (CL) wearers with CLD symptoms (CLDEQ-8 ≥12 points) were included in the study', 'Subjects with Meibomian gland dysfunction (MGD']","['habitual contact lens discomfort (CLD) management strategies: lid hygiene, daily disposable CL (DDCL) fitting, and artificial tear (AT) supplementation']","['Changes in symptoms (CLDEQ-8) and CS', 'CS-2', 'lower tear meniscus area (LTMA), bulbar, limbal, and tarsal hyperemia, noninvasive tear break-up time (NITBUT), and corneal and conjunctival staining', 'CLD symptoms', 'CLD', 'CLDEQ-8']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1828397', 'cui_str': 'Low tear meniscus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",2.0,0.0238636,"CS-2 was higher (P=0.04) in DGM subjects after lid hygiene, it decreased (P=0.04) after DDCL use.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Arroyo-Del Arroyo', 'Affiliation': 'Ocular Surface Group, Instituto Universitario de Oftalmobiología Aplicada (IOBA) (C.A.-d.A., I.F., A.N.-D., M.B.-V., A.L.-M., M.J.G.-G.), Universidad de Valladolid, Valladolid, Spain; Departamento de Física Teórica (C.A.-d.A., A.N.-D., M.J.G.-G.), Atómica y Óptica, Universidad de Valladolid, Valladolid, Spain; Networking Research Center on Bioengineering (I.F., M.J.G.-G.), Biomaterials and Nanomedicine (CIBER-BBN), Valladolid, Spain; and Redes Temáticas de Investigación Cooperativa en Salud (Oftared) (A.L.-M.), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Novo-Diez', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Blanco-Vázquez', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'López-Miguel', 'Affiliation': ''}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'González-García', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000727']
2673,32649390,Efficacy of Azithromycin Eyedrops for Individuals With Meibomian Gland Dysfunction-Associated Posterior Blepharitis.,"PURPOSE


To examine the safety and efficacy of azithromycin eyedrops in Japanese individuals with meibomian gland dysfunction (MGD)-associated posterior blepharitis.
METHODS


Individuals with MGD-associated posterior blepharitis who visited the Itoh Clinic, Saitama, Japan, were randomly assigned to receive azithromycin (1%) eyedrops (AZM group, 16 eyes of 16 patients) or preservative-free artificial tears (control group, 20 eyes of 20 patients) for 2 weeks. All subjects also applied a warming eyelid compress twice per day. Subjective symptoms (Standardized Patient Evaluation of Eye Dryness [SPEED] score), lipid layer thickness (LLT) and interferometric pattern of the tear film, plugging and vascularity of the lid margin, noninvasive break-up time of the tear film (NIBUT) and fluorescein-based break-up time of the tear film (TBUT), corneal-conjunctival fluorescein staining score, tear meniscus height, meibum grade, meiboscore, tear osmolarity, and Schirmer test value were determined before and after treatment. Side effects of treatment were also recorded.
RESULTS


In the AZM group, SPEED score, LLT, interferometric pattern, plugging and vascularity of the lid margin, NIBUT, TBUT, meibum grade, and tear osmolarity were significantly improved after treatment compared with baseline. The SPEED score, interferometric pattern, plugging, vascularity, meibum grade, and tear osmolarity were also significantly improved after treatment in the AZM group compared with the control group. Common side effects in the AZM group were transient eye irritation and blurred vision.
CONCLUSION


Azithromycin eyedrops improved eyelid inflammation, the quality and quantity of the lipid layer of the tear film, and tear film stability. Such eyedrops thus seem to be a safe and effective treatment for MGD-associated posterior blepharitis.",2020,"CONCLUSION


Azithromycin eyedrops improved eyelid inflammation, the quality and quantity of the lipid layer of the tear film, and tear film stability.","['Individuals With Meibomian Gland Dysfunction-Associated Posterior Blepharitis', 'Individuals with MGD-associated posterior blepharitis who visited the Itoh Clinic, Saitama, Japan', 'Japanese individuals with meibomian gland dysfunction (MGD)-associated posterior blepharitis']","['azithromycin eyedrops', 'AZM', 'azithromycin (1%) eyedrops (AZM group, 16 eyes of 16 patients) or preservative-free artificial tears (control group', 'Azithromycin eyedrops', 'Azithromycin Eyedrops']","['SPEED score, interferometric pattern, plugging, vascularity, meibum grade, and tear osmolarity', 'SPEED score, LLT, interferometric pattern, plugging and vascularity of the lid margin, NIBUT, TBUT, meibum grade, and tear osmolarity', 'eyelid inflammation, the quality and quantity of the lipid layer of the tear film, and tear film stability', 'safety and efficacy', 'transient eye irritation and blurred vision', 'Subjective symptoms (Standardized Patient Evaluation of Eye Dryness [SPEED] score), lipid layer thickness (LLT) and interferometric pattern of the tear film, plugging and vascularity of the lid margin, noninvasive break-up time of the tear film (NIBUT) and fluorescein-based break-up time of the tear film (TBUT), corneal-conjunctival fluorescein staining score, tear meniscus height, meibum grade, meiboscore, tear osmolarity, and Schirmer test value']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C5197842', 'cui_str': 'Meibomian Lipids'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235266', 'cui_str': 'Eye irritation'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0200992,"CONCLUSION


Azithromycin eyedrops improved eyelid inflammation, the quality and quantity of the lipid layer of the tear film, and tear film stability.","[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Itoh Clinic (R.A.), Saitama, Japan; Lid and Meibomian Gland Working Group (R.A., S.F.), Tokyo, Japan; and Omiya Hamada Eye Clinic (S.F.), Saitama, Japan.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Fukuoka', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000729']
2674,31835978,Transfusing Platelets During Bypass Rewarming in Neonates Improves Postoperative Outcomes: A Randomized Controlled Trial.,"BACKGROUND


In neonates, transfusion of platelets  after  hemodilution from cardiopulmonary bypass (CPB) has been standard. We hypothesize that platelet administration  during the rewarming phase  before termination of CPB would reduce coagulopathy, enhance hemostasis, reduce transfusion, and improve postoperative outcomes after neonatal cardiac surgery.
METHODS


A prospective, randomized trial was performed in 46 neonates. Controls received platelets  only at the end of bypass  with other blood products to assist in hemostasis. The treatment group received 10 mL/kg of platelets during the rewarming phase of bypass after cross-clamp release. After protamine, transfusion and perioperative management protocols were identical and constant among groups.
RESULTS


Two neonates in each group were excluded secondary to postoperative need for extracorporeal support. Controls (n = 21) and treatment patients (n = 21) were similar in age, weight, case complexity, associated syndromes, single ventricle status, and CPB times. Compared to controls, the treatment group required 40% less postbypass blood products (58 ± 29 vs 103 ± 80 mL/kg,  P  = .04), and case completion time after protamine administration was 28 minutes faster ( P  = .016). The treatment group required fewer postoperative mediastinal explorations for bleeding ( P  = .045) and had a lower fluid balance ( P  = .04). The treatment group had shorter mechanical ventilation ( P  = .016) and length of intensive care unit times ( P  = .033). There were no 30-day mortalities in either group.
CONCLUSION


Platelet transfusion  during the rewarming phase  of neonatal cardiac surgery was associated with reduced bleeding and improved postoperative outcomes, compared to platelets given  after coming off bypass . Further studies are necessary to understand mechanisms and benefits of this strategy.",2020,The treatment group had shorter mechanical ventilation ( P  = .016) and length of intensive care unit times ( P  = .033).,['46 neonates'],[],"['case completion time', '30-day mortalities', 'postoperative outcomes', 'postoperative mediastinal explorations for bleeding', 'Postoperative Outcomes', 'fluid balance', 'shorter mechanical ventilation', 'reduced bleeding and improved postoperative outcomes', 'postbypass blood products', 'length of intensive care unit times']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",21.0,0.149487,The treatment group had shorter mechanical ventilation ( P  = .016) and length of intensive care unit times ( P  = .033).,"[{'ForeName': 'Nischal K', 'Initials': 'NK', 'LastName': 'Gautam', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Pierre', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Edmonds', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pawelek', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Griffin', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dodge-Khatami', 'Affiliation': 'Division of Pediatric & Congenital Heart Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salazar', 'Affiliation': 'Division of Pediatric & Congenital Heart Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, TX, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135119888155']
2675,32652012,A Chicken Production Intervention and Additional Nutrition Behavior Change Component Increased Child Growth in Ethiopia: A Cluster-Randomized Trial.,"BACKGROUND


Chicken production in the context of nutrition-sensitive agriculture may benefit child nutrition in low-income settings.
OBJECTIVES


This study evaluated effects of 1) a chicken production intervention [African Chicken Genetic Gains (ACGG)], and 2) the ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG + Agriculture to Nutrition (ATONU)], on child nutrition and health outcomes and hypothesized intermediaries.
METHODS


Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20 ACGG + ATONU villages in addition received a nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention. We assessed effects of the interventions on height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ) at 9 (midline) and 18 mo (endline) through unadjusted and adjusted ordinary least squares (OLS) regressions. We examined the interventions' effects on hypothesized intermediaries including egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models.
RESULTS


Data included 829 children aged 0-36 mo at baseline. ACGG + ATONU children had higher midline HAZ [mean difference (MD): 0.28; 95% CI: 0.02, 0.54] than controls. The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant. At endline, differences in ACGG + ATONU children's HAZ and WAZ compared with controls were similar in magnitude to those of ACGG, but not statistically significant. There were no differences in anthropometry between the intervention groups. ACGG + ATONU children had higher dietary diversity and egg consumption than ACGG children at endline. Both interventions showed improvements in chicken management practices. The interventions did not increase anemia, diarrhea, fever, or vomiting, and the ACGG + ATONU group at midline showed reduced risk of fever.
CONCLUSIONS


A chicken production intervention with or without nutrition-sensitive BCC may have benefited child nutrition and did not increase morbidity.This trial was registered at clinicaltrials.gov as NCT03152227.",2020,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","['Increased Child Growth in Ethiopia', 'Forty ACGG villages received 25 genetically improved chickens and basic husbandry guidance; of these, 20\xa0ACGG\xa0+\xa0ATONU villages in addition received a', '829 children aged 0-36 mo at baseline']","['nutrition-sensitive behavior change and homegardening intervention; 20 control clusters received no intervention', 'Chicken Production Intervention and Additional Nutrition Behavior Change Component', 'chicken production intervention [African Chicken Genetic Gains (ACGG', 'ACGG intervention with nutrition-sensitive behavior change communication (BCC) [ACGG\xa0+ Agriculture to Nutrition (ATONU']","['anemia, diarrhea, fever, or vomiting', 'chicken management practices', 'height-for-age z scores (HAZ), weight-for-age z scores (WAZ), and weight-for-height z scores (WHZ', 'risk of fever', ""egg production and consumption, dietary diversity, women's empowerment, income, child morbidities, anemia, and chicken management practices through OLS and log binomial models"", 'morbidity']","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0001829', 'cui_str': 'Farming'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0600585', 'cui_str': 'Practice Management'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0026338', 'cui_str': 'Models, Binomial'}]",829.0,0.130307,"The ACGG group had higher HAZ (MD: 0.28; 95% CI: 0.05, 0.50) and higher WAZ (MD: 0.18; 95% CI: 0.01, 0.36) at endline than controls; after adjusting for potential baseline imbalance, effects were similar but not statistically significant.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Passarelli', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Ambikapathi', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Nilupa S', 'Initials': 'NS', 'LastName': 'Gunaratna', 'Affiliation': 'Department of Public Health, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Madzorera', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Canavan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Abdallah R', 'Initials': 'AR', 'LastName': 'Noor', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Amare', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Yemane', 'Initials': 'Y', 'LastName': 'Berhane', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Semira', 'Initials': 'S', 'LastName': 'Abdelmenan', 'Affiliation': 'Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Bertha', 'Initials': 'B', 'LastName': 'Munthali', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Tshilidzi', 'Initials': 'T', 'LastName': 'Madzivhandila', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Lindiwe M', 'Initials': 'LM', 'LastName': 'Sibanda', 'Affiliation': 'Food, Agriculture and Natural Resources Policy Analysis Network, Pretoria, South Africa.'}, {'ForeName': 'Kumlachew', 'Initials': 'K', 'LastName': 'Geremew', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadelle', 'Initials': 'T', 'LastName': 'Dessie', 'Affiliation': 'International Livestock Research Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Abegaz', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Getnet', 'Initials': 'G', 'LastName': 'Assefa', 'Affiliation': 'Ethiopian Institute of Agricultural Research, Addis Ababa, Ethiopia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Davison', 'Affiliation': 'Boston College School of Social Work, Boston, MA, USA.'}, {'ForeName': 'Wafaie', 'Initials': 'W', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa181']
2676,32652024,Medium-Chain Triglycerides (8:0 and 10:0) Increase Mini-Mental State Examination (MMSE) Score in Frail Elderly Adults in a Randomized Controlled Trial.,"BACKGROUND


Supplementation with medium-chain triglycerides (MCTs) was previously shown to increase muscle function in frail elderly individuals.
OBJECTIVE


We aimed to assess effects of MCTs on cognition in such individuals.
METHODS


We enrolled 64 elderly nursing home residents (85.5 ± 6.8 y; 13 men, 51 women; BMI 18.6 ± 2.5 kg/m2) in a 3-mo randomized, controlled, single-blinded, intervention trial. Participants were randomly allocated to 3 groups: the first group received supplemental L-leucine (1.2 g) and cholecalciferol (20 μg) enriched with 6 g/d of MCTs (LD + MCT group) as a positive control, the second group received 6 g/d of MCTs (MCT group) as the test nutrient, and the third group received 6 g/d of long-chain triglycerides (LCT group) as a negative control. Cognition (secondary outcome) was monitored 4 times: baseline, 1.5 and 3 mo after initiation of the intervention (intervention), and 1.5 mo after termination of the intervention (postintervention follow-up). Cognition scores were assessed by a linear mixed model (intention-to-treat analysis).
RESULTS


MCT supplementation increased the Mini-Mental State Examination (MMSE) score by 3.5 points at the 3-mo intervention from baseline (P < 0.001) [intention-to-treat adjusted means: baseline 17.5 points (95% CI: 14.9, 20.2), 3-mo intervention 21.0 points (18.3, 23.7)], whereas LCT supplementation decreased the MMSE score by -0.7 points [baseline 17.0 points (95% CI: 14.4, 19.6), 3-mo intervention 16.3 points (13.6, 18.9)]. At the 3-mo intervention, the difference in MMSE score between the MCT (21.0 points) and LCT (16.3 points) groups became significant (P < 0.05). The increase in MMSE score in response to MCTs was 2.1-fold greater at 3 mo than at 1.5 mo and had returned to baseline value at the 4.5-mo postintervention follow-up visit.
CONCLUSION


Supplementation with 6 g MCTs/d may improve the cognition of frail elderly individuals. This trial was registered at umin.ac.jp as UMIN000023302.",2020,"RESULTS


MCT supplementation increased the Mini-Mental State Examination (MMSE) score by 3.5 points at the 3-mo intervention from baseline (P < 0.001) [intention-to-treat adjusted means: baseline 17.5 points (95% CI: 14.9, 20.2), 3-mo intervention 21.0 points (18.3, 23.7)], whereas LCT supplementation decreased the MMSE score by -0.7 points [baseline 17.0 points (95% CI: 14.4, 19.6), 3-mo intervention 16.3 points (13.6, 18.9)].","['frail elderly individuals', 'Frail Elderly Adults', '64 elderly nursing home residents (85.5\xa0±\xa06.8 y; 13 men, 51 women; BMI 18.6\xa0±\xa02.5\xa0kg/m2']","['cholecalciferol (20 μg) enriched with 6\xa0g/d of MCTs (LD\xa0+\xa0MCT group) as a positive control, the second group received 6\xa0g/d of MCTs (MCT group) as the test nutrient, and the third group received 6\xa0g/d of long-chain triglycerides (LCT group) as a negative control', 'supplemental L-leucine', 'Supplementation with medium-chain triglycerides (MCTs', 'MCT', 'Supplementation with 6\xa0g MCTs', 'MCT supplementation', 'MCTs', 'Medium-Chain Triglycerides (8:0 and 10:0']","['Increase Mini-Mental State Examination (MMSE', 'Mini-Mental State Examination (MMSE) score', 'Cognition scores', 'MMSE score']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0556091', 'cui_str': 'Long chain triglyceride supplementation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",64.0,0.280505,"RESULTS


MCT supplementation increased the Mini-Mental State Examination (MMSE) score by 3.5 points at the 3-mo intervention from baseline (P < 0.001) [intention-to-treat adjusted means: baseline 17.5 points (95% CI: 14.9, 20.2), 3-mo intervention 21.0 points (18.3, 23.7)], whereas LCT supplementation decreased the MMSE score by -0.7 points [baseline 17.0 points (95% CI: 14.4, 19.6), 3-mo intervention 16.3 points (13.6, 18.9)].","[{'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': ""Institute of Women's Health Science, Showa Women's University, Tokyo, Japan.""}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ezaki', 'Affiliation': ""Institute of Women's Health Science, Showa Women's University, Tokyo, Japan.""}, {'ForeName': 'Motohisa', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Day Care SKY, Yokohama, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa186']
2677,32652064,Validation of an enhanced recovery after surgery protocol in gynecological surgery: an Italian randomized study.,"OBJECTIVE


The study aims to validate an enhanced recovery after surgery (ERAS) protocol in gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer) and to measure the adherence to ERAS items in a randomized trial setting.
STUDY DESIGN


In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or ERAS protocol. The primary outcome is a shorter length of stay in favor of ERAS. Secondary outcomes include measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly the quality of recovery using a validated questionnaire (QoR 15). Finally, we explored the length of stay in the prespecified subgroups at randomization, based on the type of surgical access and gynecological disease.
RESULTS


A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to ERAS. The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign surgery, 48 (28.6%) for endometrial cancer and 48 (28.6%) for ovarian cancer. Women in the ERAS group had a shorter length of stay [median 2 (IQR 2-3) versus 4 (IQR 4-7) days; p < .001]. A decreased rate of postoperative complications was noted for ERAS, as well as an earlier time to occur for all the events. Mean adherence to protocol items is 84.8% (CI 95% 79.7-89.8) and we registered a better satisfaction in the ERAS group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis.
CONCLUSION


Application of ERAS protocol in gynecological surgery translated in a shorter length of stay, regardless of surgical access and type of gynecological disease. Adherence to ERAS items in the setting of a randomized trial is high.",2020,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","['gynecological surgery', 'gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer', 'A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to']","['ERAS protocol', 'standard perioperative care or ERAS protocol', 'ERAS', 'surgery (ERAS) protocol']","['shortening of the length of stay', 'Mean adherence to protocol items', 'shorter length of stay in favor of ERAS', 'shorter length of stay, regardless of surgical access and type of gynecological disease', 'measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly the quality of recovery using a validated questionnaire (QoR 15', 'shorter length of stay', 'rate of postoperative complications']","[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",168.0,0.160542,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sbalzer', 'Affiliation': 'Department of Anesthesia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zizioli', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mauri', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Maggi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Sartori', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.003']
2678,32652243,Examining Reduced Opioid Prescriptions After Gynecologic Laparoscopy: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To examine whether prescribing 5 tablets of 5mg oxycodone, compared to 10 tablets, adequately treats pain after gynecologic laparoscopy.
DESIGN


Single-blinded randomized trial.
SETTING


Academically-affiliated ambulatory surgery center.
PATIENTS


120 women scheduled to undergo minor gynecologic laparoscopy.
INTERVENTION


Patients scheduled for ambulatory gynecologic laparoscopy were allocated to the standard tablet or low tablet number prescription groups (10 vs. 5 tablets of 5mg oxycodone). Patients also received prescriptions for acetaminophen and ibuprofen.
MEASUREMENTS AND MAIN RESULTS


Telephone surveys were conducted on postoperative days 1 and 7 to assess medication use and pain. The primary outcome was the number of oxycodone tablets used by days 1 and 7. Pre-specified secondary outcomes included unscheduled patient contacts and pain scores. With N=50 in each group and assuming standardized effect sizes, the study was powered to detect a 0.6 difference or greater when comparing the primary outcome between the groups. Forty-five and forty-seven patients in the five-tablet and ten-tablet groups respectively completed the day 7 survey. The median number of oxycodone tablets taken by day 7 was 2.0 (IQR 0.0, 4.0) in the five-tablet group and 2.5 (IQR 0.0, 5.0) in the ten-tablet group (P = .36). The majority of patients in both groups reported taking 3 oxycodone tablets or fewer by day 7. There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores. There were significantly fewer unused tablets in the 5-tablet group by day 7.
CONCLUSION


Prescribing 5 tablets of 5mg oxycodone, acetaminophen and ibuprofen is likely sufficient for most patients after minor laparoscopic surgery.",2020,"There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores.","['120 women scheduled to undergo minor gynecologic laparoscopy', 'After Gynecologic Laparoscopy', 'Academically-affiliated ambulatory surgery center', 'Forty-five and forty-seven patients in the five-tablet and ten-tablet groups respectively completed the day 7 survey', 'patients after minor laparoscopic surgery']","['oxycodone, acetaminophen and ibuprofen', 'ambulatory gynecologic laparoscopy', 'acetaminophen and ibuprofen', 'standard tablet or low tablet number prescription groups (10 vs. 5 tablets of 5mg oxycodone', 'oxycodone']","['medication use and pain', 'unscheduled patient contacts, need for additional prescriptions, or pain scores', 'median number of oxycodone tablets taken', 'number of oxycodone tablets used by days 1 and 7. Pre-specified secondary outcomes included unscheduled patient contacts and pain scores', 'Opioid Prescriptions']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1321139', 'cui_str': 'Ambulatory surgery center'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",120.0,0.226614,"There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores.","[{'ForeName': 'Kari M', 'Initials': 'KM', 'LastName': 'Plewniak', 'Affiliation': ""Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center. Electronic address: KPlewnia@Montefiore.org.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Kintzer', 'Affiliation': ""Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fazzari', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine.'}, {'ForeName': 'Ja Hyun', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': ""Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center.""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.07.001']
2679,32652300,"The impact of the additional metformin to the treatment of endometrial hyperplasia without atypia in addition to progesterone in a randomized fashion, a placebo-controlled, double blind clinical trial.","OBJECTIVE


Endometrial hyperplasia (EH) is a premalignant neoplasm. Most recently, metformin has been suggested as an adjuvant medication for treating of EH with better outcome. Recent evidence has suggested that metformin has anticancer activity by inhibiting cell proliferation and tumor growth. The aim of this study was to evaluate the effect of metformin plus megestrol acetate versus megestrol acetate alone on patient with EH without atypia.
STUDY DESIGN


This double blind placebo-controlled clinical trial was conducted among 60 women with EH without atypia. Participants were allocated to two equal groups. Treatment group (M + M) received 40 mg megestrol acetate for 14 days of one month and 1000 mg metformin daily for three months. In placebo group (M + P) each patient received the same dose of megestrol acetate plus two tablets of placebo. Endometrial biopsy was performed in all patients three weeks after the last day of medication RESULTS: Data were evaluated based on 29 and 27 women in the M + M group and M + P group, respectively. After 3 months of therapy 27 (93.1 %) women in M + M group had not EH and responded to treatment, which was statistically higher than the rate of response (19 women, 70.4 %) in M + P group.
CONCLUSIONS


This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.",2020,This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.,"['endometrial hyperplasia without atypia in addition to', '60 women with EH without atypia', 'endometrial hyperplasia without atypia', 'patient with EH without atypia']","['megestrol acetate plus two tablets of placebo', '40\u2009mg megestrol acetate', 'progesterone', 'megestrol plus metformin', 'metformin', 'megestrol', 'metformin plus megestrol acetate versus megestrol acetate alone', 'placebo']","['Endometrial biopsy', 'rate of response']","[{'cui': 'C2712711', 'cui_str': 'Benign endometrial hyperplasia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065879', 'cui_str': 'Megestrol acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0025175', 'cui_str': 'Megestrol'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]",60.0,0.508186,This study showed that megestrol plus metformin was significantly better than megestrol alone for the treatment of endometrial hyperplasia without atypia.,"[{'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Tehranian', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: afsanehtehranian@yahoo.com.""}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghahghaei-Nezamabadi', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Arab', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khalagi', 'Affiliation': ""Osteoprosis Research Center Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran; Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Aghajani', 'Affiliation': 'Medical Student, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101863']
2680,32652307,Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients with Pancreatic Masses in a Randomized Trial.,"BACKGROUND & AIMS


Given the lack of procedure standardization, findings vary from analyses of pancreatic tissues collected by endoscopic ultrasound-guided fine-needle biopsy. It is not clear which needle and technique yield best specimen for analysis. We compared the specimen quality and accuracy of diagnoses made from samples collected by fine-needle biopsy needles using different collection techniques.
METHODS


Patients found to have pancreatic masses during imaging (n=129) were randomly assigned to groups from whom pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles. A second randomization determined the technical sequence of biopsies in each patient (suction, no suction, and stylet retraction). Two independent pathologists, blinded to the type of needle and sampling technique, analyzed all the samples. Final diagnoses of malignancy were made based on surgical resection, death from cancer progression, or findings from radiology or clinical follow-up evaluations (reference standard). The primary objective was to compare cellularity of samples collected, defined as proportion of core tissue in the biopsy sample. Secondary objectives were to compare accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity.
RESULTS


One-hundred and nine patients had a final diagnosis of malignancy (84.5%) and 20 patients had benign disease (15.5%). Samples collected by fork-tip or franseen needles had significantly higher cellularity than samples collected by reverse-bevels or Menghini-tip needles (P<.001). Neoplasias were identified with greater than 90% accuracy using samples collected by fork-tip or franseen needles (P<.001 compared with other needles). On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P<.001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P<.001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P=.008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P<.001), and pancreatic mass >3 cm (OR, 1.92; 95% CI, 1.21-3.05; P=.005) were associated with high cellularity of sample.
CONCLUSIONS


In patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in diagnostic accuracy of 90% of more, were collected by fine-needle biopsy using the franseen or fork-tip needle. Clinicaltrials.gov no: NCT04085055.",2020,"On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P<.001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P<.001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P=.008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P<.001), and pancreatic mass >3 cm (OR, 1.92; 95% CI, 1.21-3.05; P=.005) were associated with high cellularity of sample.
","['Patients with Pancreatic Masses', 'Patients found to have pancreatic masses during imaging (n=129', 'patients with suspected pancreatic cancer']","['pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles', 'Endoscopic Ultrasound-Guided Fine-Needle Biopsy']","['accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity', 'final diagnosis of malignancy', 'benign disease', 'stylet retraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C1292533', 'cui_str': 'Tissue specimen'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge)'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",129.0,0.0481015,"On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P<.001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P<.001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P=.008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P<.001), and pancreatic mass >3 cm (OR, 1.92; 95% CI, 1.21-3.05; P=.005) were associated with high cellularity of sample.
","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Krall', 'Affiliation': 'Department of Pathology, AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Nirag', 'Initials': 'N', 'LastName': 'Jhala', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Temple University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Charanjeet', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology, AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Mohamedtaki', 'Initials': 'M', 'LastName': 'Tejani', 'Affiliation': 'Department of Medical Oncology, AdventHealth Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Arnoletti', 'Affiliation': 'Center for Surgical Oncology, AdventHealth Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Udayakumar', 'Initials': 'U', 'LastName': 'Navaneethan', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawes', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, FL, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, FL, USA. Electronic address: svaradarajulu@yahoo.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.042']
2681,32652388,"Buying despite negative consequences: Interaction of craving, implicit cognitive processes, and inhibitory control in the context of buying-shopping disorder.","BACKGROUND


Buying-shopping disorder (BSD) is a severe mental disorder in which individuals lose control over their buying/shopping behavior. It is debated whether BSD shares characteristics with other behavioral addictions. The current study aimed at investigating addiction-related concepts, i.e. cue-reactivity/craving, implicit cognitions, and inhibitory control mechanisms, in the context of BSD.
METHODS


An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures. To assess implicit cognitions (attentional bias and implicit associations) and inhibitory control, a visual dot probe paradigm, an implicit association test, and an affective shifting task, all with shopping-related and control pictures, were administered. The sequence of the three tasks was randomized across participants. Craving was measured prior and after the cue-reactivity paradigm and after completion of the experimental procedure. BSD severity was assessed using the Pathological Buying Screener (PBS).
RESULTS


Increases in craving during the cue-reactivity paradigm, but decreases after the experimental procedure were observed. Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control. However, we found moderating effects of attentional bias and inhibitory control as well as implicit associations and inhibitory control on the relationship between craving and BSD severity.
DISCUSSION/CONCLUSION


Results emphasize the role of cue-reactivity/craving, implicit cognitions and inhibitory control in the context of BSD. In line with models for behavioral addictions (I-PACE; Brand et al., 2019), the interaction of affective and cognitive biases towards shopping cues and dysfunctional inhibitory control mechanisms seems to explain the pathological engagement in buying/shopping despite negative consequences.",2020,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.",['An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures'],[],"['Craving', 'BSD severity', 'Craving, attentional bias and implicit cognitions', 'Pathological Buying Screener (PBS', 'implicit cognitions (attentional bias and implicit associations']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",277.0,0.020093,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trotzke', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany. Electronic address: patrick.trotzke@uni-due.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Starcke', 'Affiliation': 'SRH Berlin School of Popular Arts, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106523']
2682,31056923,The Implementation of Dementia Care Mapping in a Randomized Controlled Trial in Long-Term Care: Results of a Process Evaluation.,"This study explored intervention implementation within a pragmatic, cluster randomized controlled trial of Dementia Care Mapping™ (DCM) in UK care homes. DCM is a practice development tool comprised of a 5 component cycle (staff briefing, mapping observations, data analysis and reporting, staff feedback, and action planning) that supports delivery of person-centered care. Two staff from the 31 intervention care homes were trained in DCM and asked to deliver 3 cycles over a 15-month period, supported by a DCM expert during cycle 1. Implementation data were collected after each mapping cycle. There was considerable variability in DCM implementation fidelity, dose, and reach. Not all homes trained 2 mappers on schedule, and some found it difficult to retain mappers. Only 26% of homes completed more than 1 cycle. Future DCM trials in care home settings should consider additional methods to support intervention completion including intervention delivery being conducted with ongoing external support.",2019,"This study explored intervention implementation within a pragmatic, cluster randomized controlled trial of Dementia Care Mapping™ (DCM) in UK care homes.",['UK care homes'],"['DCM', 'Dementia Care Mapping™ (DCM']",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0497327', 'cui_str': 'Amentia'}]",[],,0.102869,"This study explored intervention implementation within a pragmatic, cluster randomized controlled trial of Dementia Care Mapping™ (DCM) in UK care homes.","[{'ForeName': 'Claire A', 'Initials': 'CA', 'LastName': 'Surr', 'Affiliation': '1 Centre for Dementia Research, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Alys W', 'Initials': 'AW', 'LastName': 'Griffiths', 'Affiliation': '1 Centre for Dementia Research, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelley', 'Affiliation': '1 Centre for Dementia Research, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Holloway', 'Affiliation': '2 Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rebecca E A', 'Initials': 'REA', 'LastName': 'Walwyn', 'Affiliation': '2 Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': '3 Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McDermid', 'Affiliation': '4 Wolfson Centre for Age Related Diseases, Kings College London, London, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Chenoweth', 'Affiliation': '5 Centre for Healthy Brain Ageing, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': '2 Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317519845725']
2683,30523735,Statistical Analysis Plan for EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) trial.,"BACKGROUND


EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients.
OBJECTIVE


To formulate the detailed statistical analysis plan for the EXTEND trial prior to database lock. This statistical analysis plan is based on the published and registered EXTEND trial protocol and is developed by the blinded steering committee and management team.
RESULTS


The developed EXTEND statistical analysis plan is transparent, verifiable, and predetermined before the database lock. It is consistent with reporting standards for clinical trials and provides for clear and open reporting.
CONCLUSIONS


Publication of a statistical analysis plan serves to reduce potential trial analysis and reporting bias and outlines pre-specified analyses to quantify the benefits and harms of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke patients. Trial registration: ClinicalTrials.gov number NCT00887328 registered 23/Apr/2009 and NCT01580839 (EXTEND International) registered 19/Apr/2012.",2020,"BACKGROUND


EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients.
",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.40566,"BACKGROUND


EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients.
","[{'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Bruce Cv', 'Initials': 'BC', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493018816101']
2684,30785361,Insights on HPV vaccination in the United States from mothers' comments on Facebook posts in a randomized trial.,"In the United States, parents' health beliefs affect HPV vaccination decisions for children. Our team acquired insights into mothers' health beliefs from their reactions and comments to posts on HPV vaccination in a social media adolescent health campaign in a randomized trial (n = 881 mothers; 63.1% reported daughters had 1+ doses of the HPV vaccine) evaluating communication intended to reduce daughters' indoor tanning. A total of 10 HPV vaccination messages in didactic (n = 7) and narrative (n = 3) formats were posted on vaccination need, uptake, and effectiveness and stories of young women who died from cervical cancer and a mother's decision to vaccinate her daughters. These posts received 28 reactions (like, love, and sad buttons; mean = 2.8 per post) and 80 comments (mean = 8.0 per post). More comments were favorable (n = 43) than unfavorable (n = 34). Data was not collected on views for posts. The most common favorable comment reported that daughters were vaccinated (n = 31). Unfavorable comments cited safety concerns, lack of physician support, distrust of pro-vaccine sources, and increased sexual activity of daughters. Mothers posting unfavorable (18.2%) as opposed to favorable (78.6%) comments or not commenting (64.0%) were less likely to have had their daughters vaccinated (chi-square = 22.27, p < 0.001). Favorable comments often did not state reasons for vaccinating. Concerns about lack of vaccine safety remain a barrier. Mothers may express distrust in pro-vaccine sources to reduce discomfort with not vaccinating daughters to reduce their risk for HPV infection. Many mothers who remained silent had vaccinated daughters, which suggests they did not resisit HPV vaccination.",2019,"Mothers posting unfavorable (18.2%) as opposed to no comments (64.0%) or favorable (78.6%) comments were less likely to have had their daughters vaccinated (chi-square = 22.27, p < 0.001).","[""young women who died from cervical cancer and a mother's decision to vaccinate her daughters""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}]",[],[],881.0,0.0624855,"Mothers posting unfavorable (18.2%) as opposed to no comments (64.0%) or favorable (78.6%) comments were less likely to have had their daughters vaccinated (chi-square = 22.27, p < 0.001).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'a Klein Buendel, Inc , Golden , CO , USA .'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'a Klein Buendel, Inc , Golden , CO , USA .'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'a Klein Buendel, Inc , Golden , CO , USA .'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Pagoto', 'Affiliation': 'b Department of Allied Health Sciences, University of Connecticut , Storrs , CT , USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bibeau', 'Affiliation': 'b Department of Allied Health Sciences, University of Connecticut , Storrs , CT , USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'c Community and Behavioral Health, East Tennessee State University , Johnson City , TN , USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Hillhouse', 'Affiliation': 'c Community and Behavioral Health, East Tennessee State University , Johnson City , TN , USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'd Applied Social and Health Psychology, Colorado State University , Storrs , CT , USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1581555']
2685,32270482,The PANSAID randomized clinical trial: A pre-planned 1-year follow-up regarding harm.,"BACKGROUND


Limiting harm from postoperative pain treatment is important. However, long-term follow-up from acute pain trials are rare. The aim of the study was to provide long-term follow-up data regarding harm from the ""Paracetamol and Ibuprofen in Combination"" (PANSAID) trial.
METHODS


In this preplanned long-term follow-up study from the PANSAID trial, we used data from Danish national health registries (the Danish National Patient Registry and the Danish Civil Registration System) in addition to the 90-day follow-up in the original trial. The primary outcome was 1-year proportion of patients with one or more serious adverse events.
RESULTS


One-year follow-up was complete for 551 patients (99%). We found three additional patients with one or more serious adverse events in the 1-year follow-up compared with the 90-day follow-up. The relative risk of having one or more serious adverse event when randomized to ibuprofen compared with paracetamol was 1.40 (95% CI: 0.84-2.33, P = .20).
CONCLUSION


We found no statistically significant difference in 1-year serious adverse events between patients randomized to ibuprofen compared with paracetamol in patients having planned primary total hip arthroplasty. There were few additional events from the 90-day follow-up to the 1-year follow-up.",2020,"No difference in serious adverse events between the 2 treatments, paracetamol vs ibuprofen, were observed at 1 year after surgery.","['patients having planned primary total hip arthroplasty', 'acute pain management after total hip replacement surgery']","['ibuprofen', 'paracetamol vs ibuprofen', 'paracetamol', 'Paracetamol and Ibuprofen']","['1-year proportion of patients with one or more serious adverse events', '1-year serious adverse events', 'serious adverse events']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.13119,"No difference in serious adverse events between the 2 treatments, paracetamol vs ibuprofen, were observed at 1 year after surgery.","[{'ForeName': 'Kasper H', 'Initials': 'KH', 'LastName': 'Thybo', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Dpt. 7812, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology Orthopedic Research Unit, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13597']
2686,31993980,Training attenuates the influence of sensory uncertainty on confidence estimation.,"Confidence is typically correlated with perceptual sensitivity, but these measures are dissociable. For example, confidence judgements are disproportionately affected by the variability of sensory signals. Here, in a preregistered study we investigate whether this signal variability effect on confidence can be attenuated with training. Participants completed five sessions where they viewed pairs of motion kinematograms and performed comparison judgements on global motion direction, followed by confidence ratings. In pre- and post-training sessions, the range of direction signals within each stimulus was manipulated across four levels. Participants were assigned to one of three training groups, differing as to whether signal range was varied or fixed during training, and whether or not trial-by-trial accuracy feedback was provided. The effect of signal range on confidence was reduced following training, but this result was invariant across the training groups, and did not translate to improved metacognitive insight. These results suggest that the influence of suboptimal heuristics on confidence can be mitigated through experience, but this shift in confidence estimation remains coarse, without improving insight into confidence estimation at the level of individual decisions.",2020,"The effect of signal range on confidence was reduced following training, but this result was invariant across the training groups, and did not translate to improved metacognitive insight.",[],[],[],[],[],[],,0.050038,"The effect of signal range on confidence was reduced following training, but this result was invariant across the training groups, and did not translate to improved metacognitive insight.","[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'School of Psychology, The University of Queensland, McElwain Building, St Lucia, QLD, 4072, Australia. michelle.hall@uqconnect.edu.au.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Dux', 'Affiliation': 'School of Psychology, The University of Queensland, McElwain Building, St Lucia, QLD, 4072, Australia. paul.e.dux@gmail.com.'}]","Attention, perception & psychophysics",['10.3758/s13414-020-01972-w']
2687,30235968,Comparison of virtual visit versus traditional clinic for management of varicose veins.,"Introduction


The objective of this study is to compare the clinical outcomes of patients with varicose veins managed in the telemedicine clinic and traditional clinic.
Methods


Retrospective analysis of all vein procedures in the institutional Vascular Quality Initiative Varicose Vein Registry (VQI VVR) was performed from January 2015 to August 2017. Patients were divided into two groups: Telemedicine versus Traditional Clinic. Comparison data included patient demographics, past medical history, clinical outcomes, patient-reported outcomes and postoperative complications. Statistical testing included chi-square test for categorical variables and student t-test for continuous variables using the SPSS statistical software.
Results


A total of 1034 varicose vein procedures were performed during the 31-month study period. There were 75 virtual encounters in the Telemedicine Clinic (Group A) and 959 face-to-face encounters in the Traditional Clinic (Group B). Most of the demographics characteristics were clinically similar in both groups. Comparing Group A and Group B, there were no differences in age, sex, race and body mass index. Early 3-month follow up was 100% in Group A and 90.7% in Group B. Both groups had low complication rates of haematoma (1.3% vs 0.3%, p = 0.884), paraesthesia (1.3% vs 0.6%, p = 0.767) and recanalisation (1.3% vs 4.0%, p = 0.383) during the early follow up period.
Discussion


Synchronous virtual visits for patient care are feasible for the management of chronic venous disease. Patients with varicose veins who choose to undergo telemedicine evaluations have similar pre-operative demographics, clinical classification and patient outcomes.",2020,"Both groups had low complication rates of haematoma (1.3% vs 0.3%, p = 0.884), paraesthesia (1.3% vs 0.6%, p = 0.767) and recanalisation (1.3% vs 4.0%, p = 0.383) during the early follow up period.","['1034 varicose vein procedures', 'January 2015 to August 2017', 'patients with varicose veins managed in the telemedicine clinic and traditional clinic', 'Patients with varicose veins who choose to undergo']","['Telemedicine versus Traditional Clinic', 'telemedicine evaluations', 'virtual visit versus traditional clinic']","['paraesthesia', 'recanalisation', 'low complication rates of haematoma']","[{'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0034771', 'cui_str': 'Recanalization (morphologic abnormality)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",,,"Both groups had low complication rates of haematoma (1.3% vs 0.3%, p = 0.884), paraesthesia (1.3% vs 0.6%, p = 0.767) and recanalisation (1.3% vs 4.0%, p = 0.383) during the early follow up period.","[{'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Division of Vascular Surgery, Henry Ford Hospital, MI, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Mclaughlin', 'Affiliation': 'School of Medicine, Wayne State University, MI, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Zurawski', 'Affiliation': 'Division of Vascular Surgery, Henry Ford Hospital, MI, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': 'School of Medicine, Wayne State University, MI, USA.'}, {'ForeName': 'Loay', 'Initials': 'L', 'LastName': 'Kabbani', 'Affiliation': 'Division of Vascular Surgery, Henry Ford Hospital, MI, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18797181']
2688,31704302,Peroral Endoscopic Myotomy versus Pneumatic Dilation in Achalasia: Dissecting the Randomized Controlled Trial.,,2020,,['Achalasia'],['Peroral Endoscopic Myotomy versus Pneumatic Dilation'],[],"[{'cui': 'C1321756', 'cui_str': 'Achalasia (finding)'}]","[{'cui': 'C0185181', 'cui_str': 'Myotomy'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",[],,0.11197,,"[{'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Yadlapati', 'Affiliation': 'Department of Clinical Medicine, Division of Gastroenterology & Hepatology, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Clinical Medicine, VA San Diego Healthcare System, Division of Gastroenterology & Moores Cancer Center, University of California, San Diego, San Diego, California.'}]",Gastroenterology,['10.1053/j.gastro.2019.11.005']
2689,32022470,Expectancy and Utilisation of Reflexology among Women with Advanced Breast Cancer.,"OBJECTIVE


Little is understood about patient expectations and use of complementary therapies (CT) during cancer treatment. A secondary analysis of an 11-week reflexology trial among women with breast cancer was conducted. We examined factors that predicted women's expectations about reflexology for symptom relief, factors that predicted utilisation of reflexology, and whether by the end of the trial they believed that reflexology had helped with symptom management.
METHODS


Women (N = 256) were interviewed at baseline and week 11. Friend or family caregivers in the reflexology group were trained to deliver standardised sessions to patients at least once a week for 4 weeks. Baseline and week-11 reflexology expectations were analysed using general linear models. Reflexology utilisation was analysed with generalised linear mixed effects models.
RESULTS


Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use. Worsening symptoms over time were associated with greater utilisation of reflexology, but only when baseline expectancy was low. At week 11, expectancy was higher for those with greater symptom improvement.
CONCLUSIONS


Assessing patterns of patient factors, expectancy, and change in symptoms can help determine who is likely to use reflexology, and when.",2020,"RESULTS


Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","['women with breast cancer', 'Women (N\xa0=\xa0256', 'Women with Advanced Breast Cancer']",[],"['Expectancy and Utilisation of Reflexology', 'Reflexology utilisation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]",[],"[{'cui': 'C0034945', 'cui_str': 'Reflexology'}]",256.0,0.0543432,"RESULTS


Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Rottman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Wyatt', 'Affiliation': 'Michigan State University College of Nursing, East Lansing, MI, USA.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'University of Arizona College of Nursing, Tucson, AZ, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12194']
2690,32030829,A randomized trial of the acceptability of a daily multi-allergen food supplement for infants.,,2020,"This study evaluates the acceptability by parents/caregivers (parents) and tolerability by infants of a daily, single-dose, powdered food supplement containing 30 mg of protein from each of the 16 commonly allergenic foods.","['4,5', 'Infants', 'children with a food allergy']","['Daily Multi-Allergen Food Supplement', 'food allergenic protein']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",[],,0.253423,"This study evaluates the acceptability by parents/caregivers (parents) and tolerability by infants of a daily, single-dose, powdered food supplement containing 30 mg of protein from each of the 16 commonly allergenic foods.","[{'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Holl', 'Affiliation': 'Biological Sciences Division, Department of Neurology, Center for Healthcare Delivery Science and Innovation, University of Chicago, IL, USA.'}, {'ForeName': 'Lucy A', 'Initials': 'LA', 'LastName': 'Bilaver', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Finn', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Savio', 'Affiliation': 'Focus Pointe Global, Inc., St. Louis, MO, USA.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13223']
2691,32271471,The relationship between anogenital distance and benign prostate hyperplasia-related lower urinary tract symptoms.,"Anogenital distance (AGD) is the length between the genitals and anus which shows an androgenic activity in the evolution of the reproductive system in the uterine life. For prostatic evolution and development during the embryological stage, androgen exposure is required. In this study, we aimed to investigate the relationship between AGD and benign prostate hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). A total of 70 patients who were admitted to our urology clinics with LUTS due to BPH (LUTS group) and 70 patients without LUTS (control group) were included. All patients were administered an International Prostate Symptom Score form. Data including height, weight, body mass index, total prostate-specific antigen, prostate volume and uroflowmetry Qmax values of all patients were evaluated. The AGD of the LUTS and control groups was measured. The mean AGD AS  values of the LUTS group were significantly lower than the control group (p = .013). There was no statistically significant difference between the two groups in terms of the mean adjusted AGD AP  values (p = .241). However, the mean adjusted AGD AS  values were significantly lower in the LUTS group than the control group (p = .002). Our study results suggest that AGD may be a useful marker in BPH-related LUTS.",2020,The mean AGD AS  values of the LUTS group were significantly lower than the control group (p = .013).,['70 patients who were admitted to our urology clinics with LUTS due to BPH (LUTS group) and 70 patients without LUTS (control group) were included'],['LUTS'],"['mean adjusted AGD AS  values', 'height, weight, body mass index, total prostate-specific antigen, prostate volume and uroflowmetry Qmax values', 'Anogenital distance (AGD', 'mean AGD AS  values', 'mean adjusted AGD AP  values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C3839013', 'cui_str': 'Anogenital distance'}]",70.0,0.0192778,The mean AGD AS  values of the LUTS group were significantly lower than the control group (p = .013).,"[{'ForeName': 'Musab Ali', 'Initials': 'MA', 'LastName': 'Kutluhan', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Aytaç', 'Initials': 'A', 'LastName': 'Şahin', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Ürkmez', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Toprak', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Korhan', 'Initials': 'K', 'LastName': 'Akgül', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Topaktaş', 'Affiliation': 'Department of Urology, Haydarpasa Numune Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}, {'ForeName': 'Zülfü', 'Initials': 'Z', 'LastName': 'Sertkaya', 'Affiliation': 'Department of Urology, Memorial Hospital, Diyarbakır, Turkey.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Verit', 'Affiliation': 'Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, Sağlık Bilimleri University, Istanbul, Turkey.'}]",Andrologia,['10.1111/and.13589']
2692,31870306,Measuring fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention.,"BACKGROUND


Interpreting data about intervention effectiveness requires an understanding of which intervention components were delivered and whether they were delivered as planned (fidelity of delivery). These studies aimed to develop a reliable measure for assessing fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention (COTiD-UK) (Study 1) and measure fidelity of delivery of COTiD-UK across sessions, sites and occupational therapists (Study 2).
METHODS


The studies used a longitudinal observational design nested within a multi-site randomised controlled trial. Where practicable, all intervention sessions were audio-recorded. Fidelity checklists and coding guidelines were developed, piloted and refined until good agreement was achieved between two coders. Ten percent of sessions were purposively sampled from 12 sites and 31 occupational therapists. Transcripts were coded using checklists developed in Study 1; 10% of sets of intervention session transcripts were double coded to ensure that agreement was maintained. Percentages of components that were delivered were calculated for each session, site and occupational therapist.
RESULTS


A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments. COTiD-UK was delivered with moderate fidelity across all six sessions (range: 52.4-75.5%). The mean range of fidelity varied across sites (26.7-91.2%) and occupational therapists (26.7-94.1%).
CONCLUSIONS


A reliable, systematic method for measuring fidelity of delivery of COTiD-UK was developed and applied, and can be adapted for use in similar interventions. As COTiD-UK was delivered with moderate fidelity, there is a reasonable degree of confidence that intervention effects were attributable to COTiD-UK.",2019,A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments.,['Dementia-UK intervention'],[],"['fidelity of delivery for COTiD-UK', 'mean range of fidelity']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}]",[],"[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.033941,A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments.,"[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Walton', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, UK. holly.walton@ucl.ac.uk.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Tombor', 'Affiliation': 'Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Burgess', 'Affiliation': 'Research and Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Groarke', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Swinson', 'Affiliation': 'East Hertfordshire and Broxbourne Adult Disability Team, Hertfordshire County Council, Stevenage, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wenborn', 'Affiliation': 'Research and Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}]",BMC geriatrics,['10.1186/s12877-019-1385-7']
2693,31899854,Enrichment designs using placebo nonresponders.,"Enrichment designs that select placebo nonresponders have gained much attention during the last years in areas with high placebo response rates, eg, in depression. Proposals were made that re-randomize patients who did not respond to placebo during a first study phase as the sequential parallel design (SPD). This design uses in a second phase an enriched patient population where the treatment effect is expected to be more pronounced. This may be problematic if an effect in the overall population is claimed. Proposals were made to combine the treatment effects in the overall population from study phase 1 and the enriched population from study phase 2, alleviating but not solving the issue of a potential selection bias. This paper shows how this bias corresponding to the effect difference between the overall population and the enriched population depends on the variability of a potential subject-by-treatment interaction. Sample sizes are given, which lead to a significant result in the combining test with a given probability if actually the average effect in the overall population is zero. If, on the other hand, no subject-by-treatment interaction is given, the enrichment is shown to be inefficient. We conclude that enrichment designs using placebo nonresponders are not able to claim a positive average effect in the overall population if a subject-by-treatment interaction cannot be excluded. It cannot be used to demonstrate positive efficacy in the overall population in a pivotal phase III trial but may be used in early phases to demonstrate varying treatment effects between patients.",2020,We conclude that enrichment designs using placebo nonresponders are not able to claim a positive average effect in the overall population if a subject-by-treatment interaction cannot be excluded.,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.110948,We conclude that enrichment designs using placebo nonresponders are not able to claim a positive average effect in the overall population if a subject-by-treatment interaction cannot be excluded.,"[{'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Benda', 'Affiliation': 'Research Department, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Haenisch', 'Affiliation': 'Research Department, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.'}]",Pharmaceutical statistics,['10.1002/pst.1992']
2694,31973839,"Re: Samuelson et al.: Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results (Ophthalmology. 2019;126:811-821).",,2020,,['primary open-angle glaucoma and cataract'],['ab interno implanted trabecular micro-bypass'],[],"[{'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]",[],,0.0188452,,"[{'ForeName': 'Karina Carvalho', 'Initials': 'KC', 'LastName': 'Melo Araújo', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil.'}, {'ForeName': 'Elson Cabral', 'Initials': 'EC', 'LastName': 'Velanes Neto', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Bassoli Scoralick', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, Federal University of São Paulo, Brazil.'}, {'ForeName': 'Fabio Nishimura', 'Initials': 'FN', 'LastName': 'Kanadani', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil; Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Tiago Santos', 'Initials': 'TS', 'LastName': 'Prata', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, Federal University of São Paulo, Brazil; Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida. Electronic address: t.prata0807@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.042']
2695,32058422,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': 'X-D Wu, D. Wu, Y. Liu, Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. W. Huang, Department of Orthopaedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001158']
2696,31311799,Compounded creams no better than placebo creams for localised chronic pain.,,2020,,['localised chronic pain'],['placebo creams'],[],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0927942,,"[{'ForeName': 'Jiale', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Nurse Anesthesia, Virginia Commonwealth University, Richmond, Virginia, USA.'}]",Evidence-based nursing,['10.1136/ebnurs-2019-103128']
2697,32077071,Task representation affects the boundaries of behavioral slowing following an error.,"Researchers have recognized the role that task representation plays in our behavior for many years. However, the specific influence that the structure of one's task representation has on executive functioning has only recently been investigated. Prior research suggests that adjustments of cognitive control are affected by subtle manipulations of aspects of the stimulus-response pairs within and across task sets. This work has focused on examples of cognitive control such as response preparation, dual-task performance, and the congruency sequence effect. The current study investigates the effect of task representation on another example of control, post-error slowing. To determine if factors that influence how people represent a task affect how behavior is adjusted after an error, an adaptive attention-shifting task was developed with multiple task delimiting features. Participants were randomly assigned to a separate task set (two task sets) or an integrated task set (one task set) group. For the separate set group, the task sets switched after each trial. Results showed that only the integrated set group exhibited post-error slowing. This suggests that task representation influences the boundaries of cognitive control adjustments and has implications for our understanding of how control is organized when adjusting to errors in performance.",2020,Results showed that only the integrated set group exhibited post-error slowing.,[],[],[],[],[],[],,0.0284616,Results showed that only the integrated set group exhibited post-error slowing.,"[{'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Northwestern University, 102 Swift Hall: 2029 Sheridan Road, Evanston, IL, 60208, USA. derek.smith1@northwestern.edu.'}, {'ForeName': 'Tobin', 'Initials': 'T', 'LastName': 'Dykstra', 'Affiliation': 'Department of Psychological & Brain Sciences, The University of Iowa, W311 Seashore Hall: 301-323 E Jefferson St, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Eliot', 'Initials': 'E', 'LastName': 'Hazeltine', 'Affiliation': 'Department of Psychological & Brain Sciences, The University of Iowa, W311 Seashore Hall: 301-323 E Jefferson St, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Schumacher', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, J. S. Coon Building: 648 Cherry St NW, Atlanta, GA, 30313, USA. eschu@gatech.edu.'}]","Attention, perception & psychophysics",['10.3758/s13414-020-01985-5']
2698,32118608,CORR Insights®: Can an Integrative Care Approach Improve Physical Function Trajectories after Orthopaedic Trauma? A Randomized Controlled Trial.,,2020,,[],[],['Physical Function Trajectories'],[],[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.12488,,"[{'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'J. A. Bishop, Associate Professor, Stanford University Medical Center, Department of Orthopaedic Surgery, Redwood City, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001195']
2699,31405765,"Paroxetine, but not Vortioxetine, Impairs Sexual Functioning Compared With Placebo in Healthy Adults: A Randomized, Controlled Trial.","INTRODUCTION


Sexual dysfunction is prevalent among patients with depression, but assessment of treatment-emergent sexual dysfunction (TESD), a common side effect of antidepressants, can be confounded by the treatment of depressive symptoms in some patients.
AIM


To evaluate sexual functioning in healthy volunteers administered vortioxetine compared with paroxetine, an antidepressant known to cause sexual dysfunction, and placebo.
METHODS


This phase 4, multicenter, randomized, double-blind, placebo-controlled, 4-arm, fixed-dose, head-to-head study compared sexual functioning in healthy volunteers administered vortioxetine (10 and 20 mg once daily [QD]), paroxetine (20 mg QD), or placebo for 5 weeks. Approximately equal numbers of men and women ages 18-40 years with normal sexual functioning (self-reported Changes in Sexual Functioning Questionnaire Short-Form [CSFQ-14] score > 47 for men; > 41 for women) were enrolled. Two modified full analysis sets adjusting for treatment non-compliance were prespecified.
MAIN OUTCOME MEASURE


The primary endpoint was change in CSFQ-14 total score for vortioxetine (10 and 20 mg) vs paroxetine after 5 weeks. Additional endpoints included CSFQ-14 change scores vs placebo, CSFQ-14 subscales, and patient global impression.
RESULTS


Of the 361 subjects enrolled (mean age, 28.4 years), approximately 57% were white, 34% black/African American, and 4% Asian. Vortioxetine 10 mg was associated with significantly less TESD than paroxetine (mean difference, +2.74 points; P = .009). Although vortioxetine 20 mg was associated with numerically less TESD than paroxetine (mean difference, +1.05 points), this difference did not reach statistical significance. Non-compliance appeared to influence results, particularly the paroxetine and vortioxetine 20 mg arms. Paroxetine, but not vortioxetine, was associated with statistically significantly more TESD vs placebo. Vortioxetine also had better outcomes than paroxetine in the 3 phases and 5 dimensions of sexual functioning measured by CSFQ-14.
CLINICAL IMPLICATIONS


These data establish that vortioxetine is associated with less TESD than paroxetine in healthy individuals, suggesting that vortioxetine may be a drug of choice in managing depressive disorders when sexual functioning is a concern.
STRENGTHS & LIMITATIONS


Conducting the study in healthy adults mitigated the risk of an underlying condition (eg, depression) confounding the results. Assay sensitivity was demonstrated by statistically significant TESD with paroxetine vs placebo. The single comparator, paroxetine, and short study duration limit the generalizability of these results.
CONCLUSION


Vortioxetine is associated with less TESD than paroxetine in healthy adults across all phases and dimensions of the sexual response cycle. Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results. Jacobsen P, Zhong W, Nomikos G, et al. Paroxetine, but not Vortioxetine, Impairs Sexual Functioning Compared With Placebo in Healthy Adults: A Randomized, Controlled Trial. J Sex Med 2019; 16:1638-1649.",2019,"Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results.","['healthy volunteers administered', 'Healthy Adults', 'approximately 57% were white, 34% black/African American, and 4% Asian', 'healthy individuals', 'Approximately equal numbers of men and women ages 18-40 years with normal sexual functioning (self-reported Changes in Sexual Functioning Questionnaire Short-Form [CSFQ-14] score > 47 for men; > 41 for women) were enrolled', 'patients with depression', 'healthy adults', '361 subjects enrolled (mean age, 28.4 years']","['vortioxetine (10 and 20 mg once daily [QD]), paroxetine (20 mg QD), or placebo', 'paroxetine', 'paroxetine and vortioxetine', 'Paroxetine', 'placebo', 'vortioxetine', 'Placebo', 'Vortioxetine']","['CSFQ-14 change scores vs placebo, CSFQ-14 subscales, and patient global impression', 'CSFQ-14 total score', 'Assay sensitivity', 'TESD', 'sexual functioning']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",361.0,0.40004,"Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nomikos', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA. Electronic address: ahc8v@virginia.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.018']
2700,32130184,Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial.,"BACKGROUND


Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital.
OBJECTIVE


This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes.
METHODS


This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change.
RESULTS


We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI -0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months).
CONCLUSIONS


We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176.",2020,"The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI -0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes.","['persons with type 2 diabetes', 'We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention', 'Persons With Type', 'The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking']","['usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data', 'nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology', 'Usual Care', 'Nurse Coaching and Mobile Health']","['physical activity', 'self-efficacy', 'diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety', 'Self-Efficacy', 'diabetes self-efficacy (Diabetes Empowerment Scale', 'self-efficacy and depression scores', 'diabetes self-efficacy and self-management', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C4505341', 'cui_str': 'Patient Generated Health Data'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",319.0,0.108352,"The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI -0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes.","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Young', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Sheridan', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'College of Nursing, The Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Dharmar', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'Yajarayma', 'Initials': 'Y', 'LastName': 'Tang-Feldman', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16665']
2701,31957638,Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial.,"STUDY OBJECTIVES


To assess the effects of a yoga versus educational film (EF) program on restless legs syndrome (RLS) symptoms and related outcomes in adults with RLS.
METHODS


Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or EF program (n = 22). In addition to attending classes, all participants completed practice/treatment logs. Yoga group participants were asked to practice at home 30 minutes per day on nonclass days; EF participants were instructed to record any RLS treatments used on their daily logs. Core outcomes assessed pretreatment and posttreatment were RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL).
RESULTS


Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white). Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04). Relative to the EF group, yoga participants demonstrated significantly greater reductions in RLS symptoms and symptom severity (P ≤ .01), and greater improvements in perceived stress and mood (P ≤ .04), as well as sleep quality (P = .09); RLS symptoms decreased to minimal/mild in 77% of yoga group participants, with none scoring in the severe range by week 12, versus 24% and 12%, respectively, in EF participants. In the yoga group, IRLS and RLS severity scores declined with increasing minutes of homework practice (r = .7, P = .009 and r = .6, P = .03, respectively), suggesting a possible dose-response relationship.
CONCLUSIONS


Findings of this exploratory RCT suggest that yoga may be effective in reducing RLS symptoms and symptom severity, decreasing perceived stress, and improving mood and sleep in adults with RLS.
CLINICAL TRIAL REGISTRATION


Registry: Clinicaltrials.gov; Title: Yoga vs. Education for Restless Legs: a Feasibility Study; Identifier: NCT03570515; URL: https://clinicaltrials.gov/ct2/show/NCT03570515.",2020,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","['Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white', 'adults with RLS', 'Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS']","['yoga versus educational film (EF) program', 'EF program', 'educational film intervention']","['RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL', 'RLS symptoms and symptom severity', 'RLS symptoms', 'IRLS and RLS severity scores', 'symptoms of restless legs syndrome and related outcomes', 'perceived stress and mood', 'restless legs syndrome (RLS) symptoms', 'sleep quality', 'RLS symptoms and severity, perceived stress, mood, and QOL-mental health']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",30.0,0.153714,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","[{'ForeName': 'Kim E', 'Initials': 'KE', 'LastName': 'Innes', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Terry Kit', 'Initials': 'TK', 'LastName': 'Selfe', 'Affiliation': 'Health Science Center Libraries, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Zenzi', 'Initials': 'Z', 'LastName': 'Huysmans', 'Affiliation': 'West Virginia University College of Physical Activity and Sport Sciences, Morgantown, West Virginia.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Hausmann', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Maryanna', 'Initials': 'M', 'LastName': 'Klatt', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8134']
2702,32122216,"Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial.","Background Off-target properties of ticagrelor might reduce microvascular injury and improve clinical outcome in patients with ST-segment-elevation myocardial infarction. The REDUCE-MVI (Evaluation of Microvascular Injury in Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel) trial reported no benefit of ticagrelor regarding microvascular function at 1 month. We now present the follow-up data up to 1.5 years. Methods and Results We randomized 110 patients with ST-segment-elevation myocardial infarction to either ticagrelor 90 mg twice daily or prasugrel 10 mg once a day. Platelet inhibition and peripheral endothelial function measurements including calculation of the reactive hyperemia index and clinical follow-up were obtained up to 1.5 years. Major adverse clinical events and bleedings were scored. An intention to treat and a per-protocol analysis were performed. There were no between-group differences in platelet inhibition and endothelial function. At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31). Platelet inhibition was lower at 1 month versus 1 year in the total study population (61% [42%-81%] versus 83% [61%-95%];  P <0.001), and per-protocol platelet inhibition was higher in patients randomized to ticagrelor versus prasugrel at 1 year (91% [83%-97%] versus 82% [65%-92%];  P =0.002). There was an improvement in intention to treat endothelial function in patients randomized to ticagrelor ( P =0.03) but not in patients randomized to prasugrel ( P =0.88). Major adverse clinical events (10% versus 14%;  P =0.54) and bleedings (47% versus 63%;  P =0.10) were similar in the intention-to-treat analysis in both groups. Conclusions Platelet inhibition at 1 year was higher in the ticagrelor group, without an accompanying increase in bleedings. Endothelial function improved over time in ticagrelor patients, while it did not change in the prasugrel group. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique Identifier: NCT02422888.",2020,At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31).,"['Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With', 'Patients Presenting With', 'patients with ST-segment-elevation myocardial infarction', '110 patients with ST-segment-elevation myocardial infarction to either']","['ticagrelor 90\xa0mg twice daily or prasugrel 10\xa0mg once a day', 'Ticagrelor Versus Prasugrel Maintenance Therapy', 'ticagrelor', 'Ticagrelor Versus Prasugrel']","['intention to treat endothelial function', 'Major adverse clinical events', 'Conclusions Platelet inhibition', 'Endothelial function', 'Platelet inhibition', 'per-protocol platelet inhibition', 'bleedings', 'Platelet Inhibition, Endothelial Function, and Clinical Outcome', 'platelet inhibition and endothelial function', 'reactive hyperemia index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C2710121', 'cui_str': 'prasugrel 10 MG [Effient]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",110.0,0.145099,At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group ( P =0.31).,"[{'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Guus A', 'Initials': 'GA', 'LastName': 'de Waard', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISSC and Universidad Complutense de Madrid Madrid Spain.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Mejia-Renteria', 'Affiliation': 'Hospital Clínico San Carlos IDISSC and Universidad Complutense de Madrid Madrid Spain.'}, {'ForeName': 'Tim J F', 'Initials': 'TJF', 'LastName': 'Ten Cate', 'Affiliation': 'Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC Academic Medical Center Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology Medisch Spectrum Twente Enschede the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Department of Cardiology Erasmus MC Rotterdam the Netherlands.'}, {'ForeName': 'Niels P', 'Initials': 'NP', 'LastName': 'Riksen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology Erasmus MC Rotterdam the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014411']
2703,31845587,Lithium vs valproate in the maintenance treatment of bipolar I disorder: A post- hoc analysis of a randomized double-blind placebo-controlled trial.,"OBJECTIVE


Lithium and valproate are commonly used either in monotherapy or in combination with atypical antipsychotics in maintenance treatment of bipolar I disorder; however, their comparative efficacy is not well understood. This study aimed to compare the efficacy of valproate and lithium on mood stability either in monotherapy or in combination with atypical antipsychotics.
METHODS


We performed a post hoc analysis using data from a 52-week randomized double-blind, placebo-controlled trial, that recruited 159 patients with recently remitted mania during treatment with lithium or valproate and adjunctive atypical antipsychotic therapy. Patients were randomized to discontinue adjunctive atypical antipsychotic at 0, 24 or 52 weeks.
RESULTS


No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event. Valproate with 24 weeks of atypical antipsychotic was significantly superior to valproate monotherapy in preventing any mood relapse (hazard ratio: 0.46; 95% confidence interval: [0.22, 0.97]) while lithium with 24 weeks of atypical antipsychotic was superior to lithium monotherapy in preventing mania (hazard ratio: 0.27; 95% confidence interval: [0.09, 0.85]) but not depression.
CONCLUSION


Overall, this study did not find significant differences in efficacy between the two mood-stabilizing agents when used as monotherapy or in combination with atypical antipsychotics. However, study design and small sample size might have precluded from detecting an effect if true difference in efficacy existed. Further head-to-head investigations with stratified designs are needed to evaluate maintenance therapies.",2020,"No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event.","['I disorder', 'bipolar', '159 patients with recently remitted mania during treatment with']","['valproate and lithium', 'lithium monotherapy', 'placebo', 'discontinue adjunctive atypical antipsychotic', 'valproate monotherapy', 'Lithium and valproate', 'Valproate', 'lithium or valproate and adjunctive atypical antipsychotic therapy', 'Lithium vs valproate']","['mood relapse', 'mood stability', 'efficacy']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1276996', 'cui_str': 'Atypical antipsychotic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",159.0,0.59792,"No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event.","[{'ForeName': 'Mehar G', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': ""School of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Centre for Health Evaluation & Outcome Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Keramatian', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Chakrabarty', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Saraf', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867419894067']
2704,32122821,Intravascular ultrasound to guide left main stem intervention: a NOBLE trial substudy.,"AIMS


We aimed to investigate the association between the use and findings of IVUS with clinical outcomes in the PCI arm of a randomised trial of LMS PCI.
METHODS AND RESULTS


The NOBLE trial randomised patients with LMS disease to treatment by PCI or CABG. Of 603 patients treated by PCI, 435 (72%) underwent post-PCI IVUS assessment, 224 of which were analysed in a core laboratory. At five years, the composite of MACCE was 18.9% if post-PCI IVUS was performed versus 25.0% if it was not performed (p=0.45, after adjustment). Overall repeat revascularisation was not reduced (10.6% vs 16.5%, p=0.11); however, LMS TLR was (5.1% vs 11.6%, p=0.01) if IVUS was used. For comparison of stent expansion, LMS MSA was split into tertiles. We found no significant difference in MACCE, death, myocardial infarction or stent thrombosis between tertiles. There was a significant difference between the lower and upper tertiles for repeat revascularisation (17.6% vs 5.2%, p=0.02) and LMS TLR (12.2% vs 0%, p=0.002).
CONCLUSIONS


Post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE; however, there is an association with reduced LMS TLR. The use of intracoronary imaging to prevent stent underexpansion in LMS PCI is likely to improve outcomes.",2020,"Overall repeat revascularization was not reduced (10.6% vs. 16.5%, p=0.11), however LMS TLR was (5.1% vs. 11.6%, p=0.01) if IVUS was used.","['patients with LMS disease to treatment by PCI or CABG', '603 patients treated by PCI, 435(72%) underwent post-PCI IVUS assessment of which 224 were analysed in a core-laboratory']",['Intravascular ultrasound to guide left main stem intervention'],"['composite of MACCE', 'lower and upper tertiles for repeat revascularisation', 'LMS TLR', 'MACCE, death, myocardial infarction or stent thrombosis', 'Overall repeat revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",603.0,0.254773,"Overall repeat revascularization was not reduced (10.6% vs. 16.5%, p=0.11), however LMS TLR was (5.1% vs. 11.6%, p=0.01) if IVUS was used.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ladwiniec', 'Affiliation': 'Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': ''}, {'ForeName': 'Colm G', 'Initials': 'CG', 'LastName': 'Hanratty', 'Affiliation': ''}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Mäkikallio', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kellerth', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': ''}, {'ForeName': 'Lone J H', 'Initials': 'LJH', 'LastName': 'Mogensen', 'Affiliation': ''}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': ''}, {'ForeName': 'Ian B A', 'Initials': 'IBA', 'LastName': 'Menown', 'Affiliation': ''}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': ''}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Spence', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': ''}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01003']
2705,31644357,"Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer.","PURPOSE


We previously reported the safety and immunologic effects of a DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP) in patients with recurrent, nonmetastatic prostate cancer. The current trial evaluated the effects of this vaccine on metastatic progression.
PATIENTS AND METHODS


Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months were randomly assigned to treatment with either pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF alone six times at 14-day intervals and then quarterly for 2 years. The primary end point was 2-year metastasis-free survival (MFS). Secondary and exploratory end points were median MFS, changes in PSA DT, immunologic effects, and changes in quantitative  18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging.
RESULTS


Two-year MFS was not different between study arms (41.8% vaccine  v  42.3%;  P  = .97). Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13). Preplanned subset analysis identified longer MFS in vaccine-treated patients with rapid (< 3 months) pretreatment PSA DT (12.0  v  6.1 months; n = 21; HR, 4.4;  P  = .03). PAP-specific T cells were detected in both cohorts, including multifunctional PAP-specific T-helper 1-biased T cells. Changes in total activity (total standardized uptake value) on  18 F-NaF PET/CT from months 3 to 6 increased 50% in patients treated with GM-CSF alone and decreased 23% in patients treated with pTVG-HP (n = 31;  P  = .07).
CONCLUSION


pTVG-HP treatment did not demonstrate an overall increase in 2-year MFS in patients with castration-sensitive prostate cancer, with the possible exception of a subgroup with rapidly progressive disease. Prespecified  18 F-NaF PET/CT imaging conducted in a subset of patients suggests that vaccination had detectable effects on micrometastatic bone disease. Additional trials using pTVG-HP in combination with PD-1 blockade are under way.",2019,"Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13).","['patients with recurrent, nonmetastatic prostate cancer', 'patients with castration-sensitive prostate cancer', 'Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months', 'Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer']","['GM-CSF', 'pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF', 'DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP', 'DNA', 'Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816', 'vaccine', 'pTVG-HP treatment', 'pTVG-HP']","['PSA DT and median MFS', 'total activity (total standardized uptake value', 'micrometastatic bone disease', 'PAP-specific T cells', 'median MFS, changes in PSA DT, immunologic effects, and changes in quantitative  18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging', '2-year metastasis-free survival (MFS', '2-year MFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0523444', 'cui_str': 'Prostatic acid phosphatase measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.082602,"Changes in PSA DT and median MFS were not different between study arms (18.9  v  18.3 months; hazard ratio [HR], 1.6;  P  = .13).","[{'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Johnson', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Roth', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Perk', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeraj', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University of Wisconsin, Madison, WI.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01701']
2706,32122219,Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction.,"Background ST-segment-elevation myocardial infarction is associated with an intense acute inflammatory response and risk of heart failure. We tested whether interleukin-1 blockade with anakinra significantly reduced the area under the curve for hsCRP (high sensitivity C-reactive protein) levels during the first 14 days in patients with ST-segment-elevation myocardial infarction (VCUART3 [Virginia Commonwealth University Anakinra Remodeling Trial 3]). Methods and Results We conducted a randomized, placebo-controlled, double-blind, clinical trial in 99 patients with ST-segment-elevation myocardial infarction in which patients were assigned to 2 weeks treatment with anakinra once daily (N=33), anakinra twice daily (N=31), or placebo (N=35). hsCRP area under the curve was significantly lower in patients receiving anakinra versus placebo (median, 67 [interquartile range, 39-120] versus 214 [interquartile range, 131-394] mg·day/L;  P <0.001), without significant differences between the anakinra arms. No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months. The incidence of death or new-onset heart failure or of death and hospitalization for heart failure was significantly lower with anakinra versus placebo (9.4% versus 25.7% [ P =0.046] and 0% versus 11.4% [ P =0.011], respectively), without difference between the anakinra arms. The incidence of serious infection was not different between anakinra and placebo groups (14% versus 14%;  P =0.98). Injection site reactions occurred more frequently in patients receiving anakinra (22%) versus placebo (3%;  P =0.016). Conclusions In patients presenting with ST-segment-elevation myocardial infarction, interleukin-1 blockade with anakinra significantly reduces the systemic inflammatory response compared with placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01950299.",2020,"No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months.","['Patients With ST-Segment-Elevation Myocardial Infarction', '99 patients with ST-segment-elevation myocardial infarction in which patients']","['placebo', 'anakinra once daily (N=33), anakinra twice daily (N=31), or placebo', 'Interleukin-1 Blockade']","['systemic inflammatory response', 'interval changes in left ventricular end-systolic volume', 'left ventricular ejection fraction', 'Injection site reactions', 'incidence of serious infection', 'hsCRP area under the curve', 'incidence of death or new-onset heart failure or of death and hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",99.0,0.692654,"No significant differences were found between anakinra and placebo groups in the interval changes in left ventricular end-systolic volume (median, 1.4 [interquartile range, -9.8 to 9.8] versus -3.9 [interquartile range, -15.4 to 1.4] mL;  P =0.21) or left ventricular ejection fraction (median, 3.9% [interquartile range, -1.6% to 10.2%] versus 2.7% [interquartile range, -1.8% to 9.3%];  P =0.61) at 12 months.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Buckley', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lipinski', 'Affiliation': 'Medstar Heart and Vascular Institute MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Appleton', 'Affiliation': 'Virginia Cardiovascular Specialists Richmond VA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Roberts', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Nayef', 'Initials': 'N', 'LastName': 'Abouzaki', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Melchior', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Sanah', 'Initials': 'S', 'LastName': 'Christopher', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Turlington', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mueller', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garnett', 'Affiliation': 'Virginia Cardiovascular Specialists Richmond VA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Wohlford', 'Affiliation': 'Department of Pharmacotherapy and Outcomes Science MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Puckett', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Medina de Chazal', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Juan G', 'Initials': 'JG', 'LastName': 'Chiabrando', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Bressi', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Marco Giuseppe', 'Initials': 'MG', 'LastName': 'Del Buono', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Schatz', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Vo', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Giuseppe G', 'Initials': 'GG', 'LastName': 'Biondi-Zoccai', 'Affiliation': ""Department of Medico-Surgical Sciences and Biotechnologies Sapienza' University of Rome Latina Italy.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kontos', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Virginia Commonwealth University Pauley Heart Center MedStar Washington Hospital Center Washington DC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014941']
2707,32074281,"Efficacy, safety and tolerability of progesterone vaginal pessaries versus progesterone vaginal gel for luteal phase support after in vitro fertilisation: a randomised controlled trial.","STUDY QUESTION


Are progesterone vaginal pessaries 400 mg twice a day (bid) non-inferior to progesterone vaginal gel (90 mg) once a day (od) in the primary endpoint of clinical pregnancy rate after 38 days of luteal phase support in women undergoing in vitro fertilisation (IVF)?
SUMMARY ANSWER


Non-inferiority of progesterone vaginal pessaries 400 mg bid to progesterone 8% vaginal gel (90 mg od) was shown for clinical pregnancy rate after 38 days of luteal phase support.
WHAT IS KNOWN ALREADY


To maximise successful embryo transfer after IVF, additionally administered progesterone is used for proper endometrium transformation in the luteal phase. Vaginally administered progesterone results in adequate secretory transformation of the endometrium.
STUDY DESIGN, SIZE, DURATION


This multicentre, multinational, open, randomised, two-parallel group, non-inferiority Phase 3 clinical trial was carried out at 17 study sites in five European countries (Belgium, Bulgaria, Czech Republic, Hungary and Serbia) between October 2013 and August 2014. An interactive web response system (IWRS) was implemented for treatment allocation at the sites. Power analysis, based on the assumptions of a non-inferiority margin of -9%, a significance level of α 2.5% (one-sided), power 90%, at a reference pregnancy rate for the progesterone vaginal gel group of 30%, as well as applying a dropout rate of 10%, yielded a total number of 766 patients to be randomised.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Women aged between 18 and 40 years with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) and embryo transfer were eligible to participate. The clinical pregnancy rate was assessed by fetal heart movement measured by transvaginal ultrasound at day 38 (D38) (primary endpoint) and D70. Also assessed were biochemical pregnancy rate (assessed by serum β-hCG ≥25 IU/L), clinical implantation rates at D38, patient evaluation of vaginal bleeding and discharge (assessed by diary) and adverse event (AE) incidence, severity and relationship to study medication.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 769 female patients were randomised to progesterone 400 mg vaginal pessaries bid (n = 385, 50.1%) or progesterone 90 mg vaginal gel od (n = 384, 49.9%). Patients receiving progesterone vaginal pessaries and progesterone vaginal gel were comparable in demographics, baseline characteristics and number of retrieved oocytes. In the full analysis set (FAS; n = 369 progesterone vaginal pessaries and n = 368 progesterone vaginal gel), clinical pregnancy rates on D38 were 38.3% for progesterone vaginal pessaries and 39.9% for progesterone vaginal gel. In the per protocol analysis set (PP; n = 357 progesterone vaginal pessaries and n = 356 progesterone vaginal gel), clinical pregnancy rates on D38 were 38.1% for progesterone vaginal pessaries and 40.4% for progesterone vaginal gel. For the differences in pregnancy rates between the progesterone vaginal pessaries group and the progesterone vaginal gel, the lower limit of the 97.5% CI was -8.6 and -9.5% for the FAS and PP datasets, respectively. The original prespecified non-inferiority margin of -9% was thus met in the FAS dataset but was marginally below this in the PP dataset. However, the pregnancy rate of the comparator was higher than the anticipated rate of 30%, and a predetermined logistic regression model including treatment group, country and age group effects without interaction terms showed non-inferiority of progesterone vaginal pessaries to progesterone vaginal gel for both the FAS and PP populations, in that the lower limits of the 95% CIs were above 0.7 for both analyses. As a result of this, the relevant authorities accepted to widen the acceptable non-inferiority margin to -10%, and as such both the FAS and PP populations succeeded in showing non-inferiority. Biochemical pregnancy and clinical implantation rates were comparable for both treatments. Both treatment groups showed similar high compliance throughout the study, and the safety profiles were also comparable between the groups. Drug-related AEs occurred with frequencies of 15.1% with progesterone vaginal pessaries and 14.4% with progesterone vaginal gel.
LIMITATIONS, REASONS FOR CAUTION


Clinical pregnancy rate is a surrogate for the outcome of live birth rate.
WIDER IMPLICATIONS OF THE FINDINGS


Progesterone 400 mg pessaries bid for luteal phase support is an effective, safe and tolerable treatment option for women undergoing IVF during ART.
STUDY FUNDING/COMPETING INTEREST(S)


This work was funded by Actavis Group PTC ehf., Iceland, part of Teva Pharmaceuticals, and by L.D. Collins & Co. Ltd. Gedeon Richter plc has recently entered into a license and distribution agreement to commercialise the vaginal pessaries in the European Union (except Ireland/UK). The progesterone vaginal pessaries studied are now marketed as Cyclogest®, Amelgen®, Cyclovita®, Luteum and Cygest® throughout the EU, Asia and Middle East & North Africa. The competing interests are as follows. H.S.: employee of Gedeon Richter plc/PregLem S.A. C.K.: consultant to L.D. Collins & Co. Ltd and received consulting fees for work performed. T.D.H.: at the initiation and completion of this study, full professor at KU Leuven and Head of Leuven University Fertility Center at the University Hospital Gasthuisberg, Leuven, Belgium. In October 2015, T.D.H. became vice president of Global Medical Affairs Fertility at the pharmaceutical company Merck-marketing authorisation holder of the Progesterone vaginal gel (Crinone®)-and has remained a part-time professor at KU Leuven (Belgium) and adjunct professor at Yale University (New Haven, CT, USA). T.B.M.: at the initiation and completion of this study, employee of Actavis Group PTC ehf. I.K.: consultant to Actavis, later TEVA and received consulting fees for work performed. S.H.: at the initiation and completion of this study, employee of Actavis Group PTC ehf.
TRIAL REGISTRATION NUMBER


EudraCT number 2013-001105-81.
TRIAL REGISTRATION DATE


2 July 2013.
DATE OF FIRST PATIENT’S ENROLMENT


9 October 2013.",2020,"Progesterone 400 mg pessaries bid for luteal phase support is an effective, safe and tolerable treatment option for women undergoing IVF during ART.
","['women undergoing IVF during ART', 'full professor at KU Leuven and Head of Leuven University Fertility Center at the University Hospital Gasthuisberg, Leuven, Belgium', 'Women aged between 18 and 40\xa0years with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) and embryo transfer were eligible to participate', 'luteal phase support after in vitro fertilisation', '769 female patients', '17 study sites in five European countries (Belgium, Bulgaria, Czech Republic, Hungary and Serbia) between October 2013 and August 2014']","['Progesterone', 'progesterone 400\xa0mg vaginal pessaries bid', 'progesterone', 'progesterone 8% vaginal gel', 'progesterone vaginal pessaries', 'progesterone vaginal pessaries 400', 'luteal phase support in women undergoing in vitro fertilisation (IVF', '357 progesterone vaginal pessaries and n\xa0=\u2009356 progesterone vaginal gel', 'progesterone vaginal pessaries and progesterone vaginal gel', 'progesterone vaginal gel', 'progesterone 90\xa0mg vaginal gel od']","['Efficacy, safety and tolerability', 'clinical implantation rates at D38, patient evaluation of vaginal bleeding and discharge (assessed by diary) and adverse event (AE) incidence, severity and relationship to study medication', 'Biochemical pregnancy and clinical implantation rates', 'clinical pregnancy rates', 'pregnancy rate', 'biochemical pregnancy rate', 'pregnancy rates', 'safety profiles', 'clinical pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0979798', 'cui_str': 'progesterone 8 % Vaginal Gel'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1241158', 'cui_str': 'Progesterone Vaginal Gel [Crinone]'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",769.0,0.12085,"Progesterone 400 mg pessaries bid for luteal phase support is an effective, safe and tolerable treatment option for women undergoing IVF during ART.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Saunders', 'Affiliation': 'Medical Affairs, Gedeon Richter plc/PregLem S.A., 41A Route de Frontenex, 1207 Geneva, Switzerland.'}, {'ForeName': 'Cass', 'Initials': 'C', 'LastName': 'Khan', 'Affiliation': 'Clinical Development, L.D. Collins & Co. Ltd, Breakspear Park, Breakspear Way, Hemel Hempstead, Herts, HP2 4TZ, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Hooghe"", 'Affiliation': 'Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Herestraat 49, 3000 Leuven, Belgium.'}, {'ForeName': 'Thora Björg', 'Initials': 'TB', 'LastName': 'Magnúsdóttir', 'Affiliation': 'Research and Development Actavis Group PTC ehf., Reykjavikurvegur 76-78, Hafnarfjordur 220, Iceland.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Klingmann', 'Affiliation': 'General Management, Pharmaplex bvba, Av St-Hubert 51, 1970 Wezembeek-Oppem, Belgium.'}, {'ForeName': 'Sigrún', 'Initials': 'S', 'LastName': 'Hrafnsdóttir', 'Affiliation': 'Research and Development Actavis Group PTC ehf., Reykjavikurvegur 76-78, Hafnarfjordur 220, Iceland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez261']
2708,31812878,Ibudilast attenuates peripheral inflammatory effects of methamphetamine in patients with methamphetamine use disorder.,"BACKGROUND


Preclinical studies suggest that the non-selective phosphodiesterase inhibitor, Ibudilast (IBUD) may contribute to the treatment of methamphetamine (METH) use disorder through the attenuation of METH-induced inflammatory markers such as adhesion molecules, sICAM-1 and sVCAM-1, and cytokines, IL-6 and TNF-α.
OBJECTIVE


The present study aimed to test whether treatment with IBUD can attenuate peripheral markers of inflammation during a METH challenge in an inpatient clinical trial of 11 patients.
METHODS


This trial followed a randomized, within-subjects crossover design where participants received a METH challenge, during which five participants were treated with placebo then with IBUD, while the remaining six participants were treated with IBUD prior to placebo. Mixed effects regression modeled changes in peripheral markers of inflammation-sICAM-1, sVCAM-1, TNF-α, IL-6, MIF, and cathepsin D-by treatment condition, with measurements at baseline, 60 min post-METH infusion, and 360 min post-METH infusion.
RESULTS


While on placebo, sICAM-1, sVCAM-1, and cathepsin D significantly increased by 60 min post-METH infusion, while IL-6 significantly increased 360 min post-METH infusion. Treatment with IBUD significantly reduced METH-induced levels of sICAM-1, sVCAM-1, and cathepsin D at 60 min post-METH infusion.
CONCLUSIONS


Our findings demonstrate that IBUD attenuated acute pro-inflammatory effects of METH administration, which may have implications for treatment of METH use disorder.",2020,"Treatment with IBUD significantly reduced METH-induced levels of sICAM-1, sVCAM-1, and cathepsin D at 60 min post-METH infusion.
","['11 patients', 'patients with methamphetamine use disorder']","['methamphetamine', 'IBUD prior to placebo', 'placebo', 'IBUD']","['peripheral markers of inflammation-sICAM-1, sVCAM-1, TNF-α, IL-6, MIF, and cathepsin D-by treatment condition', 'sICAM-1, sVCAM-1, and cathepsin D', 'METH-induced levels of sICAM-1, sVCAM-1, and cathepsin D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0007427', 'cui_str': 'Cathepsin D (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",5.0,0.177304,"Treatment with IBUD significantly reduced METH-induced levels of sICAM-1, sVCAM-1, and cathepsin D at 60 min post-METH infusion.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Li', 'Affiliation': 'Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, United States; Division of Infectious Diseases, University of California, Los Angeles, United States. Electronic address: mjli@mednet.ucla.edu.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Briones', 'Affiliation': 'Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, United States.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Heinzerling', 'Affiliation': 'Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, United States.'}, {'ForeName': 'Mariah M', 'Initials': 'MM', 'LastName': 'Kalmin', 'Affiliation': 'Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, United States.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shoptaw', 'Affiliation': 'Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107776']
2709,31399794,Comparison of Training Efficacy Between Custom-Made Skills Simulator (CMSS) and da Vinci Skills Simulators: A Randomized Control Study.,"BACKGROUND


To compare the effectiveness of a custom-made skills simulator (CMSS) with the commercially available da Vinci ®  skills simulator (DVSS) that help improving surgical skills for effective and safe robotic surgical interventions.
METHODS


A randomized control study was conducted to determine the performance of participants after undergoing robotic surgical training. Total 64 students who had no previous experience with robotic surgery enrolled this study. After 5 min-introduction of robotic surgical system, the participants got random-assignment into two groups to perform either CMSS-or DVSS-exercises. After 15 min-practicing the corresponding simulator, task-execution performance and individual questionnaires were compared between participants trained with the CMSS and those trained with the DVSS.
RESULTS


Regardless of simulator the participants used, the system understanding and manipulation ability of the participants was found to be higher than after completing the simulation-based robotic surgical training (p < 0.05). However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
CONCLUSIONS


The training effectiveness of CMSS was not significantly different to DVSS. It can be synergetic tool to DVSS for novice trainees of robotic surgery to get accustomed to the robotic surgical system and to improve their basic robotic surgical skills.",2019,"However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
",['Total 64 students who had no previous experience with robotic surgery enrolled this study'],"['CMSS-or DVSS-exercises', 'CMSS', 'robotic surgical training', 'Custom-Made Skills Simulator (CMSS) and da Vinci Skills Simulators', 'custom-made skills simulator (CMSS) with the commercially available da Vinci ®  skills simulator (DVSS']","['required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.0229294,"However, there were no significant differences in terms of the required time to complete the tasks, and improvement of understanding the concept of robotic surgery, or surgical skill capacity between two groups (p > 0.05).
","[{'ForeName': 'Cho Rok', 'Initials': 'CR', 'LastName': 'Lee', 'Affiliation': 'Department of Thyroid and Endocrine Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Seoung Yoon', 'Initials': 'SY', 'LastName': 'Rho', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Sang Hyup', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': ""Department of Surgery, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Robot and MIS Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Chang Moo', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea. cmkang@yuhs.ac.'}]",World journal of surgery,['10.1007/s00268-019-05108-6']
2710,32118607,CORR Insights®: Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized Controlled Trial.,,2020,,[],"['CORR Insights®', 'Osteoblastic Cell Therapy']",[],[],"[{'cui': 'C0302189', 'cui_str': 'Cell Therapy'}]",[],,0.233149,,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meermans', 'Affiliation': 'G. Meermans, Orthopaedic Surgeon, Bravis Hospital, Department of Orthopaedics, Bergen Op Zoom, Brabant, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001194']
2711,31401679,"TMAO, creatine and 1-methylhistidine in serum and urine are potential biomarkers of cod and salmon intake: a randomised clinical trial in adults with overweight or obesity.","PURPOSE


To identify biomarkers to assess participants' compliance in an intervention study with high intake of cod or salmon, compared to a fish-free diet.
METHODS


In this randomised clinical trial, 62 healthy overweight/obese participants consumed 750 g/week of either cod (N = 21) or salmon (N = 22) across 5 weekly dinners, or were instructed to continue their normal eating habits but avoid fish intake (Control group, N = 19) for 8 weeks.
RESULTS


After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group. After salmon intake, serum concentrations of 1-MeHis (p = 2.0 × 10 -6 ) and creatine (p = 6.1 × 10 -4 ), and urine concentrations (relative to creatinine) of 1-MeHis (p = 4.2 × 10 -6 ) and creatine (p = 4.0 × 10 -5 ) were increased when compared to Control group. Serum and urine concentrations of TMAO were more increased following cod intake compared to salmon intake (p = 0.028 and 2.9 × 10 -4 , respectively), and serum and urine 1-MeHis concentrations were more increased after salmon intake compared to cod intake (p = 8.7 × 10 -5  and 1.2 × 10 -4 , respectively). Cod and salmon intake did not affect serum and urine concentrations of 3-methylhistidine, and only marginally affected concentrations of free amino acids and amino acid metabolites.
CONCLUSION


TMAO measured in serum or urine is a potential biomarker of cod intake, and 1-MeHis measured in serum or urine is a potential biomarker of salmon intake.",2020,"After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group.","[""participants' compliance in an intervention study with high intake of cod or salmon, compared to a fish-free diet"", '62 healthy overweight/obese participants consumed 750\xa0g/week of either cod (N\u2009=\u200921) or', 'adults with overweight or obesity']","['TMAO, creatine and 1-methylhistidine', 'salmon (N\u2009=\u200922) across 5 weekly dinners, or were instructed to continue their normal eating habits but avoid fish intake (Control group, N\u2009=\u200919) for 8\xa0weeks']","['serum and urine 1-MeHis concentrations', 'Serum and urine concentrations of TMAO', 'urine concentrations (relative to creatinine) of 1-MeHis', 'serum and urine concentrations of 3-methylhistidine', '1-MeHis', 'serum concentrations of trimethylamine N-oxide', 'serum concentrations of 1-MeHis', 'urine concentrations (relative to creatinine) of TMAO']","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0044470', 'cui_str': '1-methylhistidine'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0047600', 'cui_str': 'N(tau)-methylhistidine'}]",62.0,0.0595496,"After cod intake, serum concentrations of trimethylamine N-oxide (TMAO, p = 0.0043), creatine (p = 0.024) and 1-methylhistidine (1-MeHis, p = 0.014), and urine concentrations (relative to creatinine) of TMAO (p = 2.8 × 10 -5 ), creatine (p = 8.3 × 10 -4 ) and 1-MeHis (p = 0.016) were increased when compared to Control group.","[{'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Hagen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Helland', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bratlie', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sveier', 'Affiliation': 'Lerøy Seafood Group ASA, PO Box 7600, 5020, Bergen, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Rosenlund', 'Affiliation': 'Skretting Aquaculture Research Centre AS, PO Box 48, 4001, Stavanger, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Mohn Nutrition Research Laboratory, Department of Clinical Science, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021, Bergen, Norway.'}, {'ForeName': 'Oddrun Anita', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, Haukeland University Hospital, 5021, Bergen, Norway. oddrun.gudbrandsen@k1.uib.no.'}]",European journal of nutrition,['10.1007/s00394-019-02076-4']
2712,32039875,Neuronavigated 1 Hz rTMS of the left angular gyrus combined with visuospatial therapy in post-stroke neglect.,"BACKGROUND


Visuospatial neglect (VSN) may be caused by an inter-hemispheric imbalance of neural activity after brain injury. Repetitive transcranial magnetic stimulation (rTMS) allows rebalancing restoration to a certain degree, relieving neglect symptoms.
OBJECTIVE


This study investigates the therapeutic effect of 1 Hz rTMS applied over the left angular gyrus combined with visual scanning training in patients with left VSN in the subacute stroke phase.
METHODS


Twenty-eight patients with VSN were randomly assigned to either experimental (fifteen sessions of rTMS consisted of 1800 magnetic pulses delivered to the left angular gyrus with a neuronavigation control), or control group (fifteen sessions of sham stimulation), followed by visual scanning training. VSN severity was assessed both before and after treatment with a 3-month follow up employing the Behavioural Inattention Test and functional measures.
RESULTS


No statistically significant differences were detected in outcome measures between the rTMS and sham groups after completion of 3-week therapy and at 3-month follow up. The magnitude of stimulation effects was not associated either with lesion volume, its location, or baseline motor threshold.
CONCLUSIONS


Our study did not confirm efficacy of 1 Hz rTMS over the angular gyrus as an adjuvant method to visual scanning training in patients with VSN in the subacute stroke.",2020,No statistically significant differences were detected in outcome measures between the rTMS and sham groups after completion of 3-week therapy and at 3-month follow up.,"['patients with VSN in the subacute stroke', 'Twenty-eight patients with VSN', 'patients with left VSN in the subacute stroke phase']","['1\u200aHz rTMS', 'rTMS', '1800 magnetic pulses delivered to the left angular gyrus with a neuronavigation control), or control group (fifteen sessions of sham stimulation), followed by visual scanning training', 'Visuospatial neglect (VSN', 'Repetitive transcranial magnetic stimulation (rTMS', 'visual scanning training', 'Neuronavigated 1\u200aHz rTMS of the left angular gyrus combined with visuospatial therapy']","['Behavioural Inattention Test and functional measures', 'VSN severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0475484', 'cui_str': 'Behavioral inattention test (assessment scale)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",28.0,0.0245511,No statistically significant differences were detected in outcome measures between the rTMS and sham groups after completion of 3-week therapy and at 3-month follow up.,"[{'ForeName': 'Szczepan', 'Initials': 'S', 'LastName': 'Iwański', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Leśniak', 'Affiliation': 'Institute of Psychology, University of Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Polanowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bembenek', 'Affiliation': 'Department of Clinical Neurophysiology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Czepiel', 'Affiliation': 'Vascular Laboratory, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Seniów', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}]",NeuroRehabilitation,['10.3233/NRE-192951']
2713,32116309,A Computerized Functional Skills Assessment and Training Program Targeting Technology Based Everyday Functional Skills.,"Today, many functional skills are technology-based, so development of a technology-based training program has broad importance. Here we present a computerized functional skills training program that was paired in half of the participants with a commercially available cognitive training (CCT) program. Non-impaired older individuals (NC) aged 60+ (n=45) and similarly aged individuals with mild cognitive impairment (MCI; n=50) were randomized to receive 12 weeks of twice-weekly computerized functional skills training (CFST) or 12 weeks of twice-weekly sessions split between CCT and CFST. Skills trained were use of an ATM; internet banking; ticket kiosk; telephone and internet prescription refill; medication management; and internet shopping. As with previous functional capacity assessments, we focus on completion time for each simulation. 51 participants completed the training program, either by mastering all 6 tasks (34) or completing 12 weeks of training. 44 more participants completed 4 or more training sessions so they were also analyzed for improvement up to their last training session. Completion time for all 6 tests significantly improved from the baseline assessment to the final training session in both groups of participants (all p<0.001 with an average improvement in task completion time of 45%). Further, there was no differential improvement in MCI and NC in the 6 tests from baseline to end of training (all t<1.66, all p>0.12). Finally, combined CCT plus CFST did not differ from CSFT alone on any of the percent-change score measures (all t<1.64, all p>0.11). Both NC and MCI groups evidenced substantial improvements in performance. CCT supplementation led to similar functional gains with half as many training sessions. The NC participants proceeded through the training fairly rapidly even without CCT supplementation; MCI participants required more training but learned equivalently. These findings suggest that even in cases with memory impairments, functional skills can be efficiently learned with training.",2020,Completion time for all 6 tests significantly improved from the baseline assessment to the final training session in both groups of participants (all p<0.001 with an average improvement in task completion time of 45%).,"['Non-impaired older individuals (NC) aged 60+ (n=45) and similarly aged individuals with mild cognitive impairment (MCI; n=50', '51 participants completed the']","['computerized functional skills training program', 'CSFT', 'twice-weekly computerized functional skills training (CFST', 'Computerized Functional Skills Assessment and Training Program Targeting Technology', 'training program, either by mastering all 6 tasks (34) or completing 12 weeks of training', 'commercially available cognitive training (CCT) program', 'CCT supplementation']","['MCI and NC', 'Completion time']","[{'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0589106', 'cui_str': 'Functional skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",51.0,0.0209479,Completion time for all 6 tests significantly improved from the baseline assessment to the final training session in both groups of participants (all p<0.001 with an average improvement in task completion time of 45%).,"[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'University of Miami Miller School of Medicine; i-Function; pharvey@miami.edu.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Tibiriçá', 'Affiliation': 'i-Function; Albizu University.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'i-Function.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Czaja', 'Affiliation': 'University of Miami Miller School of Medicine; i-Function; Weill-Cornell Medical Center.'}]",Journal of visualized experiments : JoVE,['10.3791/60330']
2714,32086522,Intracytoplasmic sperm injection is not superior to conventional IVF in couples with non-male factor infertility and preimplantation genetic testing for aneuploidies (PGT-A).,"STUDY QUESTION


Does the insemination method impact the euploidy outcome in couples with non-male factor infertility?
SUMMARY ANSWER


Conventional IVF can be applied in cycles with preimplantation genetic testing for aneuploidies (PGT-A), as both IVF and ICSI generate equal numbers of euploid blastocysts.
WHAT IS KNOWN ALREADY


Ever since its introduction, the popularity of ICSI has increased tremendously, even in couples with non-male factor infertility. The use of conventional IVF is a contraindication for couples undergoing PGT to ensure monospermic fertilisation and to eliminate potential paternal contamination from extraneous sperm attached to the zona pellucida. Despite this, it has recently been shown that sperm DNA fails to amplify under the conditions used for trophectoderm biopsy samples.
STUDY DESIGN, SIZE, DURATION


This single-centre prospective pilot study included 30 couples between November 2018 and April 2019.
PARTICIPANTS/MATERIALS, SETTING, METHOD


Arab couples, with a female age between 18-40 years, body mass index ≤30 kg/m2, at least 10 cumulus oocyte complexes (COCs) following oocyte retrieval (OR) and normal semen concentration and motility (WHO) in the fresh ejaculate on the day of OR, were eligible for the study. Half of the sibling oocytes were assigned to conventional IVF, and the other half were assigned to ICSI. All embryos were cultured in a time-lapse imaging system in Global Total LP media. Blastocysts were subjected to trophectoderm biopsy on Day 5, 6 or 7 and next-generation sequencing (NGS) to determine blastocyst ploidy status. The primary objective was to determine the euploid rate in blastocysts from sibling oocytes.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 568 COCs were randomly allocated between IVF (n = 283; 9.4 ± 4.0) and ICSI (n = 285; 9.5 ± 4.1). While the incidence of normal fertilisation per cycle (6.1 ± 3.8 (64.0%) vs 6.3 ± 3.5 (65.4%); P = 0.609) was distributed equally between IVF and ICSI, the degeneration rate (0.1 ± 0.3 vs 0.7 ± 0.8; P = 0.0003) was significantly higher after ICSI and the incidence of abnormal fertilisation (≥3 pronuclei) was significantly higher after IVF (0.9 ± 1.2 vs 0.2 ± 0.4; P = 0.005). For all fertilised oocytes, there were no differences in the number of good-quality embryos on Day 3 (74% vs 78%; P = 0.467), nor in the blastulation rate on Day 5 (80.4% vs 70.8%; P = 0.076). The total number of blastocysts biopsied per cycle on Days 5, 6 and 7 was not significantly different between IVF or ICSI (4.0 ± 2.8 vs 3.9 ± 2.5; P = 0.774). With euploid rates of 49.8 and 44.1% (P = 0.755; OR: 1.05664 [0.75188-1.48494), respectively, there was no significant difference identified between IVF and ICSI (2.0 ± 1.8 vs 1.9 ± 1.7; P = 0.808) and all couples had at least one euploid blastocyst available for transfer. When considering only euploid blastocysts, the male/female ratio was 61/39 in IVF and 43/57 in ICSI (P = 0.063).
LIMITATIONS, REASON FOR CAUTION


This is a pilot study with a limited patient population of 30 couples (and 568 COCs) with a normal ovarian response. The results of our study should not be extrapolated to other patient populations.
WIDER IMPLICATIONS OF THE FINDINGS


It is safe to apply conventional IVF in couples with non-male factor infertility undergoing PGT-A.
STUDY FUNDING/COMPETING INTEREST(S)


No funding was obtained. There are no competing interests.
TRIAL REGISTRATION NUMBER


NCT03708991.",2020,"The total number of blastocysts biopsied per cycle on Days 5, 6 and 7 was not significantly different between IVF or ICSI (4.0 ± 2.8 vs 3.9 ± 2.5; P = 0.774).","['Arab couples, with a female age between 18-40\xa0years, body mass index ≤30', 'couples with non-male factor infertility and preimplantation genetic testing for aneuploidies (PGT-A', 'limited patient population of 30 couples (and 568 COCs) with a normal ovarian response', 'A total of 568 COCs', '30 couples between November 2018 and April 2019', 'couples with non-male factor infertility undergoing PGT-A.\nSTUDY FUNDING/COMPETING INTEREST(S', 'couples with non-male factor infertility']","['ICSI', 'conventional IVF', 'Intracytoplasmic sperm injection']","['total number of blastocysts biopsied per cycle', '10 cumulus oocyte complexes (COCs', 'number of good-quality embryos', 'IVF and ICSI', 'blastulation rate', 'degeneration rate', 'euploid rate in blastocysts']","[{'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0376244', 'cui_str': 'funding'}]","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}]",30.0,0.234132,"The total number of blastocysts biopsied per cycle on Days 5, 6 and 7 was not significantly different between IVF or ICSI (4.0 ± 2.8 vs 3.9 ± 2.5; P = 0.774).","[{'ForeName': 'Neelke', 'Initials': 'N', 'LastName': 'De Munck', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'El Khatib', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Abdala', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Damen', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Aşina', 'Initials': 'A', 'LastName': 'Bayram', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arnanz', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Melado', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lawrenz', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Human M', 'Initials': 'HM', 'LastName': 'Fatemi', 'Affiliation': 'IVIRMA Middle East Fertility Clinic, IVF laboratory, Abu Dhabi, United Arab Emirates.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa002']
2715,31000320,Efficacy of preoperative amino acid supplements on postoperative physical function and complications in open heart surgery patients: A study protocol for a randomized controlled trial.,"BACKGROUND


Elderly patients undergoing cardiac surgery often show poor nutritional status, muscle wasting, and sarcopenia, which are reported to affect postoperative functional recovery and incidence of complications. Amino acids are essential in maintaining nutritional status, synthesizing muscle protein, and promoting beneficial energy balance of the heart muscle. β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases. However, the efficacy of amino acid administration comprising HMB in patients undergoing open heart surgery remains unclear. This study aims to examine whether preoperative short-term aggressive amino acid administration helps support postoperative recovery of physical function and prevent complications.
METHODS


This is a single-center prospective randomized controlled trial (UMIN000030490). Patients aged ≥65 years who will be hospitalized for medical examination before cardiac surgery will be recruited. The participants will be randomly assigned to the experimental or control group. The experimental group will be administered with an amino acid supplement with HMB 1200mg, l-glutamine 7000mg, and l-arginine 7000mg once or twice per day depending on the degree of renal dysfunction, for 14-28 days preoperatively. The control group will not receive any nutritional intervention. The main outcome will be a change in the 6-min walking test distance pre- and postoperatively as a sign of functional recovery. Secondary outcomes such as the incidence of complications; physical, nutritional, and psychological states; mortality; and length of hospital stay will also be evaluated.
CONCLUSION


This clinical study will determine the effects of preoperative short-term oral amino acid supplementation with HMB, l-glutamine, and l-arginine on postoperative physical function in elderly patients undergoing cardiac surgery.",2019,β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases.,"['Patients aged ≥65 years who will be hospitalized for medical examination before cardiac surgery will be recruited', 'patients with muscle wasting due to wearing diseases', 'open heart surgery patients', 'elderly patients undergoing cardiac surgery', 'patients undergoing open heart surgery', 'Elderly patients undergoing cardiac surgery']","['amino acid supplement with HMB 1200mg, l-glutamine 7000mg, and l-arginine', 'amino acid administration comprising HMB', 'preoperative short-term oral amino acid supplementation with HMB, l-glutamine, and l-arginine', 'preoperative amino acid supplements', 'β-Hydroxy β-methylbutyric acid (HMB']","['incidence of complications; physical, nutritional, and psychological states; mortality; and length of hospital stay will also be evaluated', '6-min walking test distance pre- and postoperatively as a sign of functional recovery', 'postoperative physical function and complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0856558', 'cui_str': 'Muscle wasting (disuse)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C4708914', 'cui_str': 'Seven thousand'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0808732,β-Hydroxy β-methylbutyric acid (HMB) is a leucine metabolite known to increase muscle protein synthesis and inhibit protein catabolism; it has been used to more effectively support patients with muscle wasting due to wearing diseases.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ogawa', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan; Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Seimi', 'Initials': 'S', 'LastName': 'Satomi-Kobayashi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. Electronic address: seimik@med.kobe-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kodai', 'Initials': 'K', 'LastName': 'Komaki', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Wakida', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Gotake', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshitada', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Division of Rehabilitation Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazuhiro P', 'Initials': 'KP', 'LastName': 'Izawa', 'Affiliation': 'Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan; Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Department of Nutrition, Kobe University Hospital, Kobe, Japan; Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Hirata', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.03.011']
2716,32114889,"Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies.","Background Dyslipidemia guidelines recommend non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB) as additional targets of therapy and consider lipoprotein(a) a significant cardiovascular risk marker. The current analysis evaluates the effects of evolocumab on these parameters in various patient populations over time. Methods and Results Data from 7690 patients, 4943 of whom received at least 1 dose of evolocumab, in 15 phase 2 and phase 3 studies with a duration ranging from 12 weeks to 5 years were pooled based on study length, patient population, and ezetimibe or placebo comparator groups. Patients could receive intensive statin therapy but not in the statin intolerance and monotherapy studies. The effects of evolocumab on percent change from baseline for non-HDL-C, ApoB, and lipoprotein(a) and achievement of treatment goals for non-HDL-C and ApoB were examined. Compared with placebo, evolocumab at both approved dosing regimens substantially reduced mean non-HDL-C (Q2W dose: -49% to -56%, monthly dose: -48% to -52%), mean ApoB (Q2W dose: -46% to -52%, monthly dose: -40% to -48%), and median lipoprotein(a) (Q2W dose: -22% to -38%, monthly dose: -20% to -33%) at 12 weeks. Effects on all 3 parameters persisted over 5 years. Lipid-lowering effects were consistent among the patient populations examined (hypercholesterolemia/mixed dyslipidemia, statin intolerance, heterozygous familial hypercholesterolemia, and type 2 diabetes mellitus). Conclusions In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo. The effect was consistent and maintained in various patient populations over 5 years.",2020,"In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo.","['7690 patients, 4943 of whom received at least 1 dose of evolocumab, in 15 phase 2 and phase 3 studies with a duration ranging from 12\xa0weeks to 5\xa0years were pooled based on study length, patient population, and', 'patient populations examined (hypercholesterolemia/mixed dyslipidemia, statin intolerance, heterozygous familial hypercholesterolemia, and type 2 diabetes mellitus']","['ezetimibe or placebo', 'Evolocumab', 'intensive statin therapy', 'placebo', 'evolocumab', 'placebo, evolocumab']","['mean ApoB ', 'Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]",7690.0,0.116167,"In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo.","[{'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'Preventive Cardiology CGH Medical Center Sterling IL.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease Baltimore MD.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Monsalvo', 'Affiliation': 'Global Development Amgen Inc. Thousand Oaks CA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Elliott-Davey', 'Affiliation': 'Global Development Amgen Ltd. Cambridge United Kingdom.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'López', 'Affiliation': 'Global Development Amgen Inc. Thousand Oaks CA.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': ""Polish Mother's Memorial Hospital Research Institute (PMMHRI) Lodz Poland.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.014129']
2717,32114892,Prognosis and Reclassification by YKL-40 in Stable Coronary Artery Disease.,"Background The inflammatory biomarker YKL-40 has previously been studied as a potential risk marker in cardiovascular disease. We aimed to assess the prognostic reclassification potential of serum YKL-40 in patients with stable coronary artery disease. Methods and Results The main study population was the placebo group of the CLARICOR (Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease) trial. The primary outcome was a composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease, and all-cause mortality. We used Cox proportional hazards regression models adjusted for C-reactive protein level and baseline cardiovascular risk factors. Improvement in prediction by adding serum YKL-40 to the risk factors was calculated using the Cox-Breslow method and c-statistic. A total of 2200 patients were randomized to placebo, with a follow-up duration of 10 years. YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001). Considering whether a composite-outcome event was more likely to have, or not have, occurred to date, we found 68.4% of such predictions to be correct when based on the standard predictors, and 68.5% when serum YKL-40 was added as a predictor. Equivalent results were obtained with c-statistics. Conclusions Higher serum YKL-40 was independently associated with an increased risk of adverse cardiovascular outcomes and mortality. Addition of YKL-40 did not improve risk prediction in patients with stable coronary artery disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00121550.",2020,"YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001).","['patients with stable coronary artery disease', 'Patients With Ischemic Heart Disease) trial', '2200 patients']","['serum YKL-40', 'YKL-40', 'placebo', 'Clarithromycin']","['risk prediction', 'Mortality and Morbidity', 'composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease, and all-cause mortality', 'risk of adverse cardiovascular outcomes and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C4517651', 'cui_str': 'Two thousand two hundred'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",2200.0,0.288654,"YKL-40 was associated with an increased risk of the composite outcome (hazard ratio per unit increase in (YKL-40) 1.13, 95% CI 1.03-1.24,  P =0.013) and all-cause mortality (hazard ratio 1.32, 95% CI 1.17-1.49,  P <0.0001).","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Schroder', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section\xa0of Biostatistics Department of Public Health Research University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology Hvidovre Hospital Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society/Division of Family Medicine Karolinska Institute Stockholm Sweden.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Harutyunyan', 'Affiliation': 'Department of Cardiology Rigshospitalet University of Copenhagen København Denmark.'}, {'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Johansen', 'Affiliation': 'Department of Medicine Herlev and Gentofte Hospital Copenhagen Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology Rigshospitalet University of Copenhagen København Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014634']
2718,31833059,Intravenous magnesium sulfate in the management of severe pre-eclampsia: A randomized study of 12-hour versus 24-hour maintenance dose.,"OBJECTIVE


To assess the effectiveness of a 12-hour versus 24-hour intravenous maintenance dose of magnesium sulfate (MgSO 4  ) in women with pre-eclampsia, and the maternal and fetal outcomes.
METHODS


This was a randomized controlled trial conducted at the labor ward complex of University College Hospital, Ibadan, Nigeria between May and August 2014. Pregnant women with severe pre-eclampsia were randomized to receive a 12-hour versus 24-hour maintenance dose of MgSO 4  . Study outcomes were occurrence of seizures, adverse maternal effects, neonatal survival, and admission to the intensive care unit. Data analysis involved descriptive statistics and bivariate analysis using Statistical Package for Social Science (SPSS) version 20.
RESULTS


There were 80 patients randomized to the 12-hour (n=40) and 24-hour (n=40) groups. The participants in the two groups had comparable demographic features. There was no significant difference (P>0.999) between the satisfactory maternal outcome following the 12-hour maintenance dose and the standard 24-hour regimen (95.0% vs 97.5%). Similarly, there was no significant difference (P=0.276) in perinatal mortality in the 12-hour versus 24-hour arm (17.5% vs 12.5%, respectively). No case of eclampsia and maternal death was recorded.
CONCLUSION


A 12-hour maintenance dose of intravenous MgSO 4  in the management of severe pre-eclampsia is effective and safe when compared with the 24-hour maintenance dose.",2020,There was no significant difference (P>0.999) between the satisfactory maternal outcome following the 12-hour maintenance dose and the standard 24-hour regimen (95.0% vs 97.5%).,"['severe pre-eclampsia', '80 patients randomized to the 12-hour (n=40) and 24-hour (n=40) groups', 'Pregnant women with severe pre-eclampsia', 'labor ward complex of University College Hospital, Ibadan, Nigeria between May and August 2014', 'women with pre-eclampsia, and the maternal and fetal outcomes']","['intravenous MgSO', 'Intravenous magnesium sulfate', 'magnesium sulfate (MgSO 4  ']","['occurrence of seizures, adverse maternal effects, neonatal survival, and admission to the intensive care unit', 'eclampsia and maternal death', 'perinatal mortality', 'satisfactory maternal outcome']","[{'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4277511', 'cui_str': 'Maternal Inheritance'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",80.0,0.19485,There was no significant difference (P>0.999) between the satisfactory maternal outcome following the 12-hour maintenance dose and the standard 24-hour regimen (95.0% vs 97.5%).,"[{'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Unwaha', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Ibadan/University College Hospital, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Folasade A', 'Initials': 'FA', 'LastName': 'Bello', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Ibadan/University College Hospital, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Oluwasomidoyin O', 'Initials': 'OO', 'LastName': 'Bello', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Ibadan/University College Hospital, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Adesina', 'Initials': 'A', 'LastName': 'Oladokun', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Ibadan/University College Hospital, Ibadan, Oyo State, Nigeria.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13082']
2719,31364911,Equivalent Systemic Exposure to Fluticasone Propionate/Salmeterol Following Single Inhaled Doses from Advair Diskus and Wixela Inhub: Results of Three Pharmacokinetic Bioequivalence Studies.,"Background:  Wixela ®  Inhub ®  was developed to deliver inhaled fluticasone propionate/salmeterol (FP/S) combination as a substitutable generic equivalent to Advair ®  Diskus ® . These studies aimed to confirm the pharmacokinetic bioequivalence (BE) of FP/S after single doses of Wixela Inhub (test [T]) and Advair Diskus (reference [R]).  Methods:  Three open-label, randomized, two-way crossover, single-dose studies in healthy subjects ( N  = 66 each) compared the systemic exposure of FP and salmeterol after inhalation from three dose strengths of FP/S (100/50, 250/50, or 500/50 μg) delivered from T and R. Primary BE endpoints were the area under the plasma concentration-time curve from time = 0 to the last measurable concentration (AUC (0-t) ) and the maximum observed plasma concentration (C max ) for both FP and S. The BE acceptance criteria specified that the 90% confidence intervals (CIs) of the geometric mean T/R ratios for AUC (0-t)  and C max  can be contained within 0.80-1.25 for both FP and salmeterol.  Results:  Wixela Inhub met the acceptance criteria for BE for FP and salmeterol at each dose strength. Estimated AUC (0-t)  and C max  geometric mean ratios (T/R [90% CI]) for FP were, respectively, 1.04 (1.00-1.08) and 0.92 (0.87-0.96) for 100/50 μg FP/S, 1.07 (1.02-1.13) and 1.01 (0.95-1.07) for 250/50 μg, and 0.97 (0.92, 1.00) and 0.90 (0.86-0.93) for 500/50 μg. Estimated AUC (0-t)  and C max  ratios for salmeterol were, respectively, 1.08 (1.04-1.11) and 1.00 (0.94-1.04) for 100/50 μg FP/S, 1.03 (0.99-1.07) and 0.93 (0.87-1.00) for 250/50 μg, and 1.00 (0.96-1.04) and 0.86 (0.81-0.91) for 500/50 μg. FP/S at all doses via both T and R was comparably well tolerated.  Conclusions:  Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.",2020,"Conclusions:  Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.",['healthy subjects ( N \u2009=\u200966 each'],"['Fluticasone Propionate/Salmeterol', 'systemic exposure of FP and salmeterol', 'fluticasone propionate/salmeterol (FP/S) combination', 'Inhaled Doses from Advair Diskus and Wixela Inhub']","['plasma concentration-time curve from time\u2009=\u20090 to the last measurable concentration (AUC (0-t) ) and the maximum observed plasma concentration (C max ', 'Estimated AUC (0-t)  and C max  geometric mean ratios', 'tolerated', 'Estimated AUC (0-t)  and C max  ratios']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0939246', 'cui_str': 'Advair Diskus'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.151234,"Conclusions:  Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Haughie', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allan', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, United Kingdom.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Wood', 'Affiliation': 'Certara UK Ltd., London, United Kingdom.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, United Kingdom.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2019.1537']
2720,32114063,Comparing Ultrasound-Guided Needling Combined With a Subacromial Corticosteroid Injection Versus High-Energy Extracorporeal Shockwave Therapy for Calcific Tendinitis of the Rotator Cuff: A Randomized Controlled Trial.,"PURPOSE


To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment.
METHODS


The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm 2 ) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%.
RESULTS


Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (<P = .001). In total, 22% of the UGN and 41% of the ESWT patients received an additional treatment during follow-up because of persistent symptoms.
CONCLUSIONS


This RCT compares the clinical and radiographic results of UGN and high-energy ESWT in the treatment of calcific tendinitis of the rotator cuff. Both techniques are successful in improving function and pain, with high satisfaction rates after 1-year follow-up. However, UGN is more effective in eliminating the calcific deposit, and the amount of additional treatments was greater in the ESWT group.
LEVEL OF EVIDENCE


II, randomized controlled trial.",2020,"At 1-year follow-up the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 versus 15.7; p=0.23), DASH (-20.1 versus -20.7; p=0.78) and VAS for pain (-3.9 and -2.6; p=0.12).","['patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment', 'calcific tendinitis of the rotator cuff', 'Eighty-two patients were treated (56 female, 65%; mean age 52.1±9 years) with a mean baseline CMS of 66.8±12 and mean calcification size of 15.1±4.7mm']","['ESWT', 'corticosteroid US-guided subacromial bursa injection', 'ultrasound-guided needling combined with a subacromial corticosteroid injection versus high-energy extracorporeal shockwave therapy', 'standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound guided needling (UGN']","['function and pain with high satisfaction rates', 'VAS for pain', 'Shoulder function', 'mean calcification size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0521515', 'cui_str': 'Calcific tendinitis (disorder)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",82.0,0.0697409,"At 1-year follow-up the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 versus 15.7; p=0.23), DASH (-20.1 versus -20.7; p=0.78) and VAS for pain (-3.9 and -2.6; p=0.12).","[{'ForeName': 'Jan K G', 'Initials': 'JKG', 'LastName': 'Louwerens', 'Affiliation': 'Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands. Electronic address: jlouwerens@spaarnegasthuis.nl.'}, {'ForeName': 'Inger N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.'}, {'ForeName': 'Erik T', 'Initials': 'ET', 'LastName': 'Kramer', 'Affiliation': 'Verheul & Weerman Physical Therapists, Nieuw-Vennep, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Boonstra', 'Affiliation': 'Paramedical Shoulder Clinic, Haarlem, the Netherlands.'}, {'ForeName': 'Michel P J', 'Initials': 'MPJ', 'LastName': 'van den Bekerom', 'Affiliation': 'Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands.'}, {'ForeName': 'Barend J', 'Initials': 'BJ', 'LastName': 'van Royen', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Eygendaal', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands; Department of Orthopaedic Surgery, Breda, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'van Noort', 'Affiliation': 'Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.027']
2721,31402574,Two years clinical outcomes with the state-of-the-art PCI for the treatment of bifurcation lesions: A sub-analysis of the SYNTAX II study.,"BACKGROUND


Bifurcation PCI is associated with a lower rate of procedural success, especially in multivessel disease patients. We aimed to determine the impact of bifurcation treatment on 2-years clinical outcomes when a state-of-the-art PCI strategy (heart team decision-making using the SYNTAX score II, physiology guided coronary stenosis assessment, thin strut bioresorbable polymer drug-eluting stent, and intravascular ultrasound guidance) is followed.
METHODS


Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281). The primary endpoint was the occurrence of major adverse cardio and cerebrovascular events (MACCE-a composite of all-cause death, stroke, any myocardial infarction, or any revascularization) at 2 years. Secondary endpoints were the occurrence of target lesion failure (TLF) defined as cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization, and the individual components of the composite primary endpoint, as well as stent thrombosis.
RESULTS


A total of 145 bifurcation were treated in 126 patients. At 2 years, MACCE occurred in 75/407 patients (20.7% for bifurcation versus 17.5% for nonbifurcation, hazard ratio [HR] of 1.28, CI95% 0.78-2.08, p = .32). TLF presented a trend toward higher occurrence in bifurcation (16.8% vs. 10.8%, HR 1.75, CI95% 0.99-3.09, p = .053). Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
CONCLUSION


Bifurcation treatment in patients with three-vessel disease undergoing state-of-the-art PCI had similar event rate of MACCE but was associated with a trend toward higher incidence of TLF compared with nonbifurcation lesions.",2020,"Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
","['Three-vessel disease patients enrolled in the SYNTAX II trial (n = 454) were categorized in patients with (a) ≥1 treated bifurcation (n = 126), and (b) without bifurcation (n = 281', 'multivessel disease patients', 'A total of 145 bifurcation were treated in 126 patients']","['MACCE', 'TLF']","['occurrence of target lesion failure (TLF) defined as cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization, and the individual components of the composite primary endpoint, as well as stent thrombosis', 'occurrence of major adverse cardio and cerebrovascular events (MACCE-a composite of all-cause death, stroke, any myocardial infarction, or any revascularization', 'Definite stent thrombosis']","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}]",[],"[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",126.0,0.0944657,"Definite stent thrombosis did not differ at 2-year between groups (0.8% for the bifurcation vs. 0.7% for the nonbifurcation, p = .92).
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'de Vries', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain.'}, {'ForeName': 'Vasim', 'Initials': 'V', 'LastName': 'Farrooq', 'Affiliation': 'Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Banning', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Cardiology, Oxford, UK.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Imperial College of London, London, UK.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28422']
2722,32084567,Double sequential external defibrillation for refractory ventricular fibrillation: The DOSE VF pilot randomized controlled trial.,"OBJECTIVES


The primary objective was to determine the feasibility and safety of a cluster randomized controlled trial (RCT) with crossover comparing vector change defibrillation (VC) or double sequential external defibrillation (DSED) to standard defibrillation for patients experiencing refractory ventricular fibrillation (VF). Secondary objectives were to assess the rates of VF termination (VFT) and return of spontaneous circulation (ROSC).
METHODS


We conducted a pilot cluster RCT with crossover in four Canadian paramedic services including all treated adult OHCA patients who presented in VF and received a minimum of three successive defibrillation attempts. Each EMS service was randomly assigned to provide standard defibrillation, VC or DSED. Agencies crossed over to an alternate defibrillation strategy after six months.
RESULTS


152 patients were enrolled. With respect to feasibility, 89.5% of cases received the defibrillation strategy they were randomly allocated to, and 93.1% of cases received a VC or DSED shock prior to the sixth defibrillation attempt. There were no safety concerns reported. In the standard group, 66.6% of cases resulted in VFT, compared to 82.0% in VC and 76.3% in the DSED group. ROSC was achieved in 25.0%, 39.3% and 40.0% of standard, VC and DSED groups, respectively.
CONCLUSIONS


Our findings suggest the DOSE-VF protocol is feasible and safe. Rates of VFT and ROSC were higher in the VC and DSED than standard defibrillation. The results of this pilot trial will allow us to inform a multicenter cluster RCT with crossover to determine if alternate defibrillation strategies for refractory VF may impact clinical outcomes.",2020,Rates of VFT and ROSC were higher in the VC and DSED than standard defibrillation.,"['152 patients were enrolled', 'Refractory Ventricular Fibrillation', 'patients experiencing refractory ventricular fibrillation (VF', 'four Canadian paramedic services including all treated adult OHCA patients who presented in VF and received a minimum of three successive defibrillation attempts']","['DOuble Sequential External Defibrillation', 'vector change defibrillation (VC) or double sequential external defibrillation (DSED', 'VC or DSED shock']","['feasibility and safety', 'rates of VF termination (VFT) and return of spontaneous circulation (ROSC', 'ROSC', 'Rates of VFT and ROSC', 'VFT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",152.0,0.138322,Rates of VFT and ROSC were higher in the VC and DSED than standard defibrillation.,"[{'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Toronto, Ontario, Canada; Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michaels Hospital, Toronto, Ontario, Canada. Electronic address: Sheldon.Cheskes@sunnybrook.ca.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': 'St. Michaels Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Toronto, Ontario, Canada; Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada; Schwartz/Reisman Emergency Medicine Institute, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Damon C', 'Initials': 'DC', 'LastName': 'Scales', 'Affiliation': 'Li Ka Shing Knowledge Institute, St. Michaels Hospital, Toronto, Ontario, Canada; Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada; Schwartz/Reisman Emergency Medicine Institute, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Turner', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': 'Li Ka Shing Knowledge Institute, St. Michaels Hospital, Toronto, Ontario, Canada; Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Drennan', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Verbeek', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Toronto, Ontario, Canada; Department of Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Resuscitation,['10.1016/j.resuscitation.2020.02.010']
2723,30629813,"Cost-Effectiveness of Combination Disease-Modifying Antirheumatic Drugs Versus Tumor Necrosis Factor Inhibitors in Active Rheumatoid Arthritis: A Pragmatic, Randomized, Multicenter Trial.","OBJECTIVE


To determine whether intensive combinations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDS) achieve similar clinical benefits more cheaply than high-cost biologics such as tumor necrosis factor inhibitors (TNFi) in patients with active rheumatoid arthritis (RA) whose illness has failed to respond to methotrexate and another DMARD.
METHODS


We used within-trial cost-effectiveness and cost-utility analyses from health and social care and 2 societal perspectives. Participants were recruited into an open-label, 12-month, pragmatic, randomized, multicenter, 2-arm, noninferiority trial in 24 rheumatology clinics in England and Wales. Costs were linked with the Health Assessment Questionnaire (HAQ; primary outcome) and quality-adjusted life years derived from 2 measures (Short-Form 36 health survey and EuroQol 5-domain 3-level instrument).
RESULTS


In total, 205 participants were recruited, 104 in the csDMARD arm and 101 in the TNFi arm. Participants in the csDMARD arm with poor response at 6 months were offered TNFi; 46 participants (44%) switched. Relevant cost and outcome data were available for 93% of participants at 6-month follow-up and for 91-92% of participants at 12-month follow-up. The csDMARD arm had significantly lower total costs from all perspectives (6-month health and social care adjusted mean difference -£3,615 [95% confidence interval (95% CI) -4,104, -3,182]; 12-month health and social care adjusted mean difference -£1,930 [95% CI -2,599, -1,301]). The HAQ score showed benefit to the csDMARD arm at 12 months (-0.16 [95% CI -0.32, -0.01]); other outcomes/follow-ups showed no differences.
CONCLUSION


Starting treatment with csDMARDs, rather than TNFi, achieves similar outcomes at significantly lower costs. Patients with active RA and who meet the National Institute for Health and Care Excellence criteria for expensive biologics can be treated with combinations of intensive csDMARDs in a cost-effective manner.",2020,The cDMARDs arm had significantly lower total costs from all perspectives (6 month H&SC adjusted mean difference -£3615 (95% confidence interval -£4104 to -£3182); 12 month H&SC adjusted mean difference -£1930,"['active rheumatoid arthritis', '24 rheumatology clinics in England', '205 participants were recruited, 104 in the cDMARDs arm, 101 in the TNFis arm', 'Patients with active rheumatoid arthritis and meeting NICE criteria', 'patients with active rheumatoid arthritis (RA) who have failed to respond to methotrexate and another DMARD']","['combination disease-modifying antirheumatics vs. tumour necrosis factor inhibitors', 'health and social care (H&SC', 'synthetic disease modifying drugs (cDMARDS']","['total costs', 'Heath Assessment Questionnaire (HAQ; primary outcome) and quality-adjusted life years (QALYs']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",205.0,0.223462,The cDMARDs arm had significantly lower total costs from all perspectives (6 month H&SC adjusted mean difference -£3615 (95% confidence interval -£4104 to -£3182); 12 month H&SC adjusted mean difference -£1930,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Anita Patel Health Economics Consulting, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Heslin', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Scott', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Birrell', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, and Newcastle University, Newcastle, UK.'}, {'ForeName': 'Fowzia', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': ""King's College London, London, UK.""}]",Arthritis care & research,['10.1002/acr.23830']
2724,30740935,Automated Text Message-Enhanced Monitoring Versus Routine Monitoring in Early Rheumatoid Arthritis: A Randomized Trial.,"OBJECTIVE


Frequent monitoring of patients with early rheumatoid arthritis (RA) is required for achieving good outcomes. This study was undertaken to investigate the influence of text message (SMS)-enhanced monitoring on early RA outcomes.
METHODS


We randomized 166 patients with early, disease-modifying antirheumatic drug-naive RA to receive SMS-enhanced follow-up or routine care. All patients attended visits at 0, 3, and 6 months, and a follow-up visit at 12 months. Treatment was at the physicians' discretion. The intervention included 13 SMSs during weeks 0-24 with questions concerning medication problems (yes/no) and disease activity (patient global assessment [PtGA], scale 0-10). Patients were contacted if response SMSs indicated medication problems or PtGA exceeded predefined thresholds. Primary outcome was 6-month Boolean remission (no swollen or tender joints and normal C-reactive protein levels). Quality of life (QoL; measured by the Short Form 36 survey) and Disease Activity Score in 28 joints (DAS28) were assessed.
RESULTS


Six and 12-month follow-up data were available for 162 and 157 patients, respectively. In the intervention group, 46% of the patients (38 of 82) reported medication problems and 49% (40 of 82) reported text message PtGAs above the alarm limit. Remission rates at 6 months (P = 0.34) were 51% in the intervention group and 42% in the control group. These rates were 57% and 43% at 12 months (P = 0.17) in the intervention and control groups, respectively. The respective mean ± SD DAS28 scores for the intervention and control groups were 1.92 ± 1.12 and 2.22 ± 1.11 at 6 months (P = 0.09); and 1.79 ± 0.91 and 2.08 ± 1.22 at 12 months (P = 0.28). No differences in QoL were observed.
CONCLUSION


The study did not meet the primary outcome despite a trend favoring the intervention group. This may be explained by the notably high overall remission rates.",2020,Remission rates in the intervention and control groups were 51% and 42% at 6 months (p=0.34); and 57% and 43% at 12 months (p=0.17).,"['early rheumatoid arthritis', '166 early, disease-modifying antirheumatic drug naive RA patients to SMS-enhanced follow-up or routine care', 'early rheumatoid arthritis (RA) patients', '162 and 157 patients']","['Automated text message enhanced monitoring versus routine monitoring', 'text message (SMS']","['QOL', 'Quality of life (QOL, Short Form 36) and 28-joint disease activity scores (DAS28', 'respective DAS28 scores', 'medication problems', 'medication problems or PGA', 'Remission rates', '6-month Boolean remission (no swollen or tender joints, normal CRP']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]",166.0,0.0766676,Remission rates in the intervention and control groups were 51% and 42% at 6 months (p=0.34); and 57% and 43% at 12 months (p=0.17).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kuusalo', 'Affiliation': 'Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Tuulikki', 'Initials': 'T', 'LastName': 'Sokka-Isler', 'Affiliation': 'Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland, and Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Ekman', 'Affiliation': 'Satakunta Central Hospital, Rauma, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Kauppi', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pirilä', 'Affiliation': 'Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Rannio', 'Affiliation': 'Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Toini', 'Initials': 'T', 'LastName': 'Uutela', 'Affiliation': 'Lapland Central Hospital, Rovaniemi, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Yli-Kerttula', 'Affiliation': 'Satakunta Central Hospital, Rauma, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Puolakka', 'Affiliation': 'South Karelia Central Hospital, Lappeenranta, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis care & research,['10.1002/acr.23846']
2725,31207152,"Live Zoster Vaccine in Patients With Rheumatoid Arthritis Treated With Tofacitinib With or Without Methotrexate, or Adalimumab With Methotrexate: A Post Hoc Analysis of Data From a Phase IIIb/IV Randomized Study.","OBJECTIVE


To explore herpes zoster (HZ) rates and live zoster vaccine (LZV) safety in a subset of patients with rheumatoid arthritis who received LZV before tofacitinib ± methotrexate (MTX), or adalimumab (ADA) plus MTX in the ORAL Strategy.
METHODS


ORAL Strategy was a 1-year, phase IIIb/IV, randomized, triple-dummy, active-comparator-controlled study. MTX-inadequate responder patients received tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus MTX, or ADA 40 mg every other week plus MTX (1:1:1 randomization). Eligible patients age ≥50 years could opt to receive LZV 28 days before initiating study treatment. HZ incidence rates (IRs; patients with events per 100 patient-years) were calculated. Opportunistic HZ infections (multidermatomal/disseminated), serious HZ events, and LZV-related adverse events were monitored.
RESULTS


In ORAL Strategy, 216 of 1,146 patients (18.8%) received LZV. Overall, 18 patients (1.6%) developed HZ (vaccinated: n = 3; nonvaccinated: n = 15). HZ IRs were 1.1 (95% confidence interval [95% CI] 0.3-2.9), 2.3 (95% CI 1.0-4.6), and 1.7 (95% CI 0.6-3.7) for tofacitinib monotherapy, tofacitinib plus MTX, and ADA plus MTX, respectively, and were generally similar between vaccinated and nonvaccinated patients. Three multidermatomal, 1 disseminated, and 2 serious HZ events occurred. No vaccinated patients had zoster-like lesions within 42 days of vaccination; 1 patient had vaccination-site erythema.
CONCLUSION


LZV was well tolerated, and HZ IRs were generally similar between treatment groups and vaccinated versus nonvaccinated patients. However, ORAL Strategy was not powered for comparisons between vaccinated and nonvaccinated patients because <20% of all patients were vaccinated. Furthermore, LZV has been shown to be effective only in ~50% of individuals.",2020,"No vaccinated patients had zoster-like lesions within 42 days of vaccination; one patient had vaccination-site erythema.
","['patients with rheumatoid arthritis (RA) who received', 'Patients with Rheumatoid Arthritis Treated with', 'Eligible patients aged ≥50 years']","['Tofacitinib with or without Methotrexate, or Adalimumab with Methotrexate', 'LZV before tofacitinib ± methotrexate (MTX), or adalimumab (ADA) + MTX', 'LZV', 'Live Zoster Vaccine', 'tofacitinib 5\xa0mg BID, tofacitinib 5\xa0mg BID + MTX, or ADA 40 mg every other week + MTX', 'MTX']","['HZ IRs', 'herpes zoster (HZ) rates, and live zoster vaccine (LZV) safety', 'zoster-like lesions', 'tolerated, and HZ IRs', 'HZ incidence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3505046', 'cui_str': 'tofacitinib 5 MG [Xeljanz]'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.29344,"No vaccinated patients had zoster-like lesions within 42 days of vaccination; one patient had vaccination-site erythema.
","[{'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Calabrese', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Abud-Mendoza', 'Affiliation': 'Hospital Central, San Luis Potosí, Mexico.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Lindsey', 'Affiliation': 'Louisiana State University School of Medicine, Baton Rouge.'}, {'ForeName': 'Sang-Heon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Konkuk University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Tatulych', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Takiya', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Iikuni', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Koshika', 'Initials': 'K', 'LastName': 'Soma', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas.'}]",Arthritis care & research,['10.1002/acr.24010']
2726,32102506,The Effect of ACE Inhibitor on the Quality of Life amongst Patients with Cancer Cachexia.,"BACKGROUND


ACEI (Angiotensin Converting Enzyme Inhibitors) inhibits tumor growth and development. Different mechanisms have been proposed for this matter, including the inhibition of enzymes that are involved in extracellular matrix degradation, matrix metalloproteinase (MMP) and etc. The present study was designed with the aim to investigate the effects of low dose ACEI on the Quality of Life (QoL) of non-hospitalized gastric cancer patients with cachexia.
MATERIALS AND METHODS


This study was a single-blinded randomized controlled clinical trial conducted in clinics affiliated with Shiraz University of Medical Sciences (SUMS). All participants were patients with gastric cancer in cancer cachexia step aged 40-80 years old who had referred to our clinics from October 2013 to April 2014. In the intervention group, patients were assigned to receive ACEI (Captopril) and the placebo group served as control and received placebo during the same time course. They were asked questions in order to fill out QLQ-C30 (Persian Version) questionnaire 3 times; baseline, 1 and 2 months after their first visit.
RESULTS


The mean age of patients was 60.55 ± 12.07 (range 31-80) years and the mean BMI of the patients was 17.21 ± 2.31. In the ACEI group, physical functioning and fatigue score changes were significant 1 and 2 months after treatment. The mean of fatigue score decreased significantly in the placebo group. Overall, global health status scores significantly increased in both groups, but other items of QoL did not change significantly.
CONCLUSION


Overall, our results showed that Captopril does not have a significant positive effect on QoL of patients with cancer cachexia.<br />.",2020,"Overall, global health status scores significantly increased in both groups, but other items of QoL did not change significantly.
","['non-hospitalized gastric cancer patients with cachexia', 'All participants were patients with gastric cancer in cancer cachexia step aged 40-80 years old who had referred to our clinics from October 2013 to April 2014', 'clinics affiliated with Shiraz University of Medical Sciences (SUMS', 'Patients with Cancer Cachexia']","['ACEI (Captopril', 'ACE Inhibitor', 'low dose ACEI', 'placebo', 'Captopril']","['Quality of Life (QoL', 'Overall, global health status scores', 'mean of fatigue score', 'physical functioning and fatigue score changes', 'Quality of Life']","[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C1391732', 'cui_str': 'Cancer cachexia'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.038795,"Overall, global health status scores significantly increased in both groups, but other items of QoL did not change significantly.
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Hematology Research Center, Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mirzaie', 'Affiliation': 'Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Farhadi', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rezvani', 'Affiliation': 'Hematology Research Center, Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.2.325']
2727,32083298,The safety and effectiveness of carbon nanoparticles suspension in tracking lymph node metastases of colorectal cancer: a prospective randomized controlled trial.,"OBJECTIVE


This study was to evaluate the safety and effectiveness of carbon nanoparticles suspension in tracking lymph node metastases of colorectal cancer.
METHODS


Eligible patients diagnosed with stages I-III colorectal cancer in Fudan University Shanghai Cancer Center between 1 May 2017 and 31 May 2018 fulfilling the inclusion criteria were included in this prospective randomized controlled study. All the patients were randomly allocated to two groups: the nanocarbon group and the control group. Patients' clinicopathological characteristics were compared between the nanocarbon group and the control group. For continuous variables, data were presented as mean (±SD) and differences between the two groups were compared by the Mann-Whitney U test; for categorical variables, data was presented as frequency (%) and the Pearson's chi-squared test was used to compare the differences between two groups.
RESULTS


All the patients' characteristics between two groups did not achieve statistical significance (P > 0.05). Patients in nanocarbon group were more likely to be associated with more lymph nodes retrieved totally compared with control group (19.84 ± 6.428 vs. 17.41 ± 7.229, P < 0.001). The number of lymph nodes retrieved in nanocarbon group were more likely to be ≥12 than that in the control group (P = 0.005).
CONCLUSIONS


Our study confirmed the safety of using carbon nanoparticles suspension as a tracer in colorectal cancer. More importantly, nanocarbon could significantly increase the detected number of lymph nodes in colorectal cancer, which can help improve the accuracy of lymph node staging and even improve patients' survival.",2020,"The number of lymph nodes retrieved in nanocarbon group were more likely to be ≥12 than that in the control group (P = 0.005).
","['tracking lymph node metastases of colorectal cancer', 'Eligible patients diagnosed with stages I-III colorectal cancer in Fudan University Shanghai Cancer Center between 1 May 2017 and 31 May 2018 fulfilling the inclusion criteria', 'colorectal cancer']","['nanocarbon', 'carbon nanoparticles suspension']","['number of lymph nodes', 'safety and effectiveness', 'lymph nodes']","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0520109,"The number of lymph nodes retrieved in nanocarbon group were more likely to be ≥12 than that in the control group (P = 0.005).
","[{'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Shaobo', 'Initials': 'S', 'LastName': 'Mo', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhaozhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Guoxiang', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xinxiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa011']
2728,32091400,Short-duration triple antithrombotic therapy for atrial fibrillation patients who require coronary stenting: results of the SAFE-A study.,"AIMS


We aimed to determine whether shortening the duration of P2Y12 inhibitor therapy can reduce the risk of bleeding without increasing the risk of major adverse cardiovascular events following coronary stenting in patients with atrial fibrillation (AF).
METHODS AND RESULTS


The SAFE-A is a randomised controlled trial that compared one-month and six-month P2Y12 inhibitor therapy, in combination with aspirin and apixaban for patients with AF who require coronary stenting. The primary endpoint was the incidence of any bleeding events, defined as Thrombolysis In Myocardial Infarction major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion within 12 months after stenting. The study aimed to enrol 600 patients but enrolment was slow. Enrolment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% male). The incidence of the primary endpoint did not differ between the one-month and six-month groups (11.8% vs 16.0%; hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.33-1.47; p=0.35).
CONCLUSIONS


The study evaluated the safety of withdrawing the P2Y12 inhibitor from triple antithrombotic prescription one month after coronary stenting. However, enrolment was prematurely terminated because it was slow. Therefore, statistical power was not sufficient to assess the differences in the primary endpoint.",2020,"The incidence of the primary endpoint did not differ between the 1-month and 6-month groups (11.8% vs 16.0%; hazard ratio, 0.70; 95% confidence interval, 0.33-1.47; P = 0.35).
","['Atrial Fibrillation Patients', 'patients with atrial fibrillation (AF', 'patients with AF who require coronary stenting', 'enroll 600 patients, but enrollment was slow', 'Enrollment was terminated prematurely after enrolling 210 patients (72.7±8.2 years; 81% men']","['aspirin and apixaban', 'coronary stenting', 'Short-Duration Triple Antithrombotic Therapy', 'Coronary Stenting']","['incidence of any bleeding events, defined as Thrombosis in Myocardial Infarction with major/minor bleeding, bleeding with various Bleeding Academic Research Consortium grades, or bleeding requiring blood transfusion']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0035168'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",210.0,0.107523,"The incidence of the primary endpoint did not differ between the 1-month and 6-month groups (11.8% vs 16.0%; hazard ratio, 0.70; 95% confidence interval, 0.33-1.47; P = 0.35).
","[{'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Hoshi', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba City, Ibaraki, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Daigo', 'Initials': 'D', 'LastName': 'Hiraya', 'Affiliation': ''}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Watabe', 'Affiliation': ''}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Takeyasu', 'Affiliation': ''}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': ''}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ohigashi', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Gosho', 'Affiliation': ''}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': ''}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00920']
2729,32101065,A Comparison of the Relative Safety and Efficacy of Laparoscopic Choledochotomy with Primary Closure and Endoscopic Treatment for Bile Duct Stones in Patients with Cholelithiasis.,"Background:  To date, several clinical trials have demonstated that both one-stage laparoscopic cholecystectomy (LC) combined with common bile duct exploration (LC+BDE) with primary closure and one-stage LC combined with endoscopic stone extraction (LC+ESE) are the two primary clinical approaches to treat cholelithiasis. However, no studies to date have directly compared the LC+BDE with primary closure and one-stage LC+ESE procedures. We, therefore, conducted a retrospective analysis of patients with cholelithiasis who had been treated through LC+ESE or LC+BDE to compare these two approaches for the treatment of cholecystitis and common bile duct stones (CCBDS).  Methods:  Consecutive CCBDS patients with cholelithiasis in our hospital who were diagnosed through Media Resource Control Protocol (MRCP) and ultrasound between June 2010 and February 2017 were randomly assigned to undergo either LC+ESE or LC+BDE, as both procedures are routinely used to treat cholelithiasis in our hospital. All patients were made aware of the risks and benefits of the surgery preoperatively, and this study was approved by the ethics committee of our institute. Outcomes in these two groups, including rates of success and reasons for operative failure, were then compared, as were data pertaining to patient demographics, clinical findings, postoperative stay duration, and medical expenses. In addition, biliary reflux as measured through computed tomography or gastrointestinal imaging was monitored for a minimum of 2 years.  Results:  In total, 207 CCBDS patients were identified during the study period and were randomized into the LC+ESE ( n  = 103) or LC+BDE ( n  = 104) treatment groups. We found that patients treated through LC+BDE achieved a significantly higher success rate than that achieved in patients treated through LC+ESE (93.3% versus 82.5%;  P  < .05). Specifically, the LC+BDE with primary closure procedure failed in patients with impacted stones located at the end of the common bile duct (CBD) and in those with stenosis of the sphincter of Oddi. The only variable that differed significantly between these two treatment groups was stone location. Variables other than stone location, CBD size, and stone size did not differ significantly between the two groups. However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  Conclusions:  We found that LC+BDE with primary closure was a safer and more effective means of treated CCBDS patients than was the LC+ESE procedure and that it was not associated with risks of sphincterotomy of duodenal papilla (EST)- or T-tube-related complications. However, our data also clearly indicate that LC+BDE cannot replace LC+ESE in all patients, and that as such both approaches should be considered as being complementary to one another, with their relative advantages in a given patient being defined based upon local resource availability and expertise. In addition, when the LC+ESE procedure fails then the LC+BDE treatment can be safely employed as a salvage approach.",2020,"However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  ","['Consecutive CCBDS patients with cholelithiasis in our hospital who were diagnosed through Media Resource Control Protocol (MRCP) and ultrasound between June 2010 and February 2017', 'Patients with Cholelithiasis', 'patients with cholelithiasis who had been treated through LC+ESE or LC+BDE to compare these two approaches for the treatment of cholecystitis and common bile duct stones (CCBDS', '207 CCBDS patients']","['Laparoscopic Choledochotomy with Primary Closure and Endoscopic Treatment', 'laparoscopic cholecystectomy (LC) combined with common bile duct exploration (LC+BDE) with primary closure and one-stage LC combined with endoscopic stone extraction (LC+ESE', 'LC+BDE', 'LC+ESE', 'LC+ESE or LC+BDE']","['stone location', 'rates of success and reasons for operative failure', 'success rate', 'patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative', 'patient demographics, clinical findings, postoperative stay duration, and medical expenses', 'biliary reflux', 'CBD size, and stone size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008325', 'cui_str': 'Gallbladder Inflammation'}, {'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}]","[{'cui': 'C0391928', 'cui_str': 'Incision of common bile duct (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009437', 'cui_str': 'Choledochus'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",207.0,0.0460479,"However, the LC+BDE treatment was associated with significant reductions in patient operating time, morbidity, hospital day duration, and biliary reflux of duodenal contents relative to the LC+ESE treatment.  ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Graduate Department of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Changzhong', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of General Surgery, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'JingWang', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0775']
2730,31885120,School-aged children with type 1 diabetes benefit more from a coping skills training program than adolescents in China: 12-month outcomes of a randomized clinical trial.,"BACKGROUND


Managing type 1 diabetes can be challenging, especially for youth, so there is a need for effective interventions to help youth live with diabetes.
OBJECTIVE


To determine the efficacy of a coping skills training (CST) program for Chinese youth with type 1 diabetes and to explore whether the efficacy of the program was different for school-aged children than for adolescents with type 1 diabetes.
METHODS


A total of 100 youth with type 1 diabetes aged 8 to 20 years were randomly placed in either an intervention group (CST + standard care [SC]) or a control group (SC). Data were collected at baseline, 6-month, and 12-month follow-ups on primary outcomes of perceived stress, coping, and self-efficacy and secondary outcomes of diabetes self-management, quality of life, and glycated hemoglobin A1c (HbA1c). A generalized estimating equation analysis for repeated measures was used to determine the program effects and differential effects by age group.
RESULTS


The CST program had no significant effect on primary or secondary outcomes over 12 months. However, there was a significant increase in positive coping (P < .001), self-efficacy (P = .017), diabetes problem-solving and goals of diabetes self-management (P = .007, P = .001), and quality of life (P = .016) of school-aged children in the intervention group compared with the control group. There were no significant differences in primary or secondary outcomes between the intervention group and the control group (P > .05).
CONCLUSIONS


The CST program was effective for school-aged children, improving psychosocial and diabetes self-management outcomes. Further research is needed to develop programs that improve outcomes in adolescents with type 1 diabetes.",2020,"There were no significant differences in primary or secondary outcomes between the intervention group and the control group (P > .05).
","['100 youth with type 1 diabetes aged 8 to 20\u2009years', 'school-aged children', 'school-aged children than for adolescents with type 1 diabetes', 'School-aged children with type 1 diabetes benefit more from a', 'adolescents with type 1 diabetes', 'Chinese youth with type 1 diabetes']","['intervention group (coping skills training + standard care) or a control group (standard care', 'coping skills training program']","['diabetes problem-solving and goals of diabetes self-management', 'quality of life', 'perceived stress, coping, and self-efficacy and secondary outcomes of diabetes self-management, quality of life, and glycated hemoglobin (HbA1c', 'self-efficacy', 'positive coping']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",100.0,0.0520067,"There were no significant differences in primary or secondary outcomes between the intervention group and the control group (P > .05).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Xiangya School of Nursing, Central South University, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Xiangya School of Nursing, Central South University, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Jundi', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Xiangya School of Nursing, Central South University, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Shenzhen University, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wiley', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Second Xiangya Hospital, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Second Xiangya Hospital, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Second Xiangya Hospital, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Whittemore', 'Affiliation': 'School of Nursing, Yale University, New Haven, Connecticut.'}]",Pediatric diabetes,['10.1111/pedi.12975']
2731,29992524,Prognostic effect and modulation of cardiac sympathetic function in heart failure patients treated with cardiac resynchronization therapy.,"BACKGROUND


Cardiac autonomic dysfunction as assessed by  123 I-metaiodobenzylguanidine ( 123 I-mIBG) scintigraphy is associated with poor prognosis in heart failure (HF) patients. Although cardiac resynchronization therapy (CRT) has emerged as an effective therapy in improving outcomes on HF patients, its effect on cardiac sympathetic nervous function is still not fully understood. We aimed to study the value of pre-implantation  123 I-mIBG late heart-to-mediastinum ratio (HMR) as a predictor of response and outcomes after CRT and to correlate modification in this parameter with CRT response and functional improvement.
METHODS AND RESULTS


BETTER-HF (Benefit of exercise training therapy and cardiac resynchronization in HF patients) is a prospective randomized clinical trial including HF patients submitted CRT (mean LVEF 24 ± 8%, 74% NYHA class ≥ III) who underwent a clinical, echocardiographic, and scintigraphic assessment before and 6 months after CRT. One-hundred and twenty-one patients were included. Echocardiographic response was observed in 54% and composite outcome of cardiac mortality, cardiac transplant or heart failure hospitalization in 24% of patients. Baseline late HMR was an independent predictor of CRT response (regression coefficient 2.906, 95% CI 0.293-3.903, P .029) and outcomes (HR 0.066 95% CI 0.005-0.880, P .040). At follow-up,  123 I-mIBG imaging showed positive changes in cardiac sympathetic nerve activity only in responders to CRT (1.36 ± 0.14 prior vs. 1.42 ± 0.16 after CRT, P .039). There was a significant correlation between improvement in late HMR and improvement in peak oxygen consumption (r 0.547, P < .001).
CONCLUSION


In our study, baseline cardiac denervation predicted response and clinical outcomes after CRT implantation. Cardiac sympathetic function was improved only in patients who responded to CRT and these positive changes were correlated with improvement in functional capacity.",2020,Cardiac sympathetic function was improved only in patients who responded to CRT and these positive changes were correlated with improvement in functional capacity.,"['One-hundred and twenty-one patients were included', 'HF patients submitted CRT (mean LVEF 24\u2009±\u20098%, 74% NYHA class\u2009≥\u2009III) who underwent a clinical, echocardiographic, and scintigraphic assessment before and 6\xa0months after CRT', 'heart failure (HF) patients', 'HF patients', 'heart failure patients treated with']","['cardiac resynchronization therapy (CRT', 'exercise training therapy and cardiac resynchronization', 'cardiac resynchronization therapy']","['CRT response', 'cardiac mortality, cardiac transplant or heart failure hospitalization', 'cardiac sympathetic nerve activity', 'late HMR', 'peak oxygen consumption', 'Echocardiographic response', 'functional capacity', 'Cardiac sympathetic function']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0228992', 'cui_str': 'Structure of middle cardiac nerve'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}]",121.0,0.06542,Cardiac sympathetic function was improved only in patients who responded to CRT and these positive changes were correlated with improvement in functional capacity.,"[{'ForeName': 'Rita Ilhão', 'Initials': 'RI', 'LastName': 'Moreira', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal. ritailhaomoreira@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abreu', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Portugal', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'Nuclear Medicine Department, Medical and Diagnosis Clinic Quadrantes, Lisbon, Portugal.'}, {'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Madalena Coutinho', 'Initials': 'MC', 'LastName': 'Cruz', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Pedro Silva', 'Initials': 'PS', 'LastName': 'Cunha', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'CIPER, Human Kinetics Faculty, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Helena Santa', 'Initials': 'HS', 'LastName': 'Clara', 'Affiliation': 'CIPER, Human Kinetics Faculty, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Miguel Mota', 'Initials': 'MM', 'LastName': 'Carmo', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Rui Cruz', 'Initials': 'RC', 'LastName': 'Ferreira', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Rua de Santa Marta, no. 50, 1169-024, Lisbon, Portugal.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-018-1357-x']
2732,31335979,Addition of low-dose liraglutide to insulin therapy is useful for glycaemic control during the peri-operative period: effect of glucagon-like peptide-1 receptor agonist therapy on glycaemic control in patients undergoing cardiac surgery (GLOLIA study).,"AIM


To test the hypothesis that the addition of a glucagon-like peptide-1 receptor agonist that can decrease glucose levels without increasing the hypoglycaemia risk will achieve appropriate glycaemic control during the peri-operative period.
METHODS


We studied 70 people with Type 2 diabetes who underwent elective cardiac surgery. Participants were randomized to either an insulin-alone or an insulin plus liraglutide 0.6 mg/day group. We evaluated average M values, which indicated the proximity index of the target glucose level from day 1 to day 10.
RESULTS


The average M value in the liraglutide plus insulin group was significantly lower than that in the insulin-alone group (liraglutide plus insulin 5.8 vs insulin-alone 12.3; P < 0.001). The frequency of insulin dose modification in the liraglutide plus insulin group was significantly lower than that in the insulin-alone group (odds ratio 0.19, 95% CI 0.08-0.49; P < 0.001). The frequency of hypoglycaemia in the liraglutide plus insulin group tended to be lower than that in the insulin-alone group (odds ratio 0.57, 95% CI 0.15-2.23; P = 0.21).
CONCLUSIONS


The results of this study showed that the addition of low-dose liraglutide to insulin achieved lower M values than insulin alone, suggesting that the addition of low-dose liraglutide may achieve better glycaemic control during the peri-operative period. (Clinical trials registry no.: UMIN 000008003).",2019,The average M value in the liraglutide plus insulin group was significantly lower than that in the insulin-alone group (liraglutide plus insulin 5.8 vs insulin-alone 12.3; P < 0.001).,"['patients undergoing cardiac surgery (GLOLIA study', '70 people with Type 2 diabetes who underwent elective cardiac surgery']","['liraglutide', 'insulin-alone or an insulin plus liraglutide', 'glucagon-like peptide-1 receptor agonist therapy', 'glucagon-like peptide-1 receptor agonist']","['frequency of hypoglycaemia', 'frequency of insulin dose modification', 'average M value', 'proximity index of the target glucose level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0998075,The average M value in the liraglutide plus insulin group was significantly lower than that in the insulin-alone group (liraglutide plus insulin 5.8 vs insulin-alone 12.3; P < 0.001).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of, Data Science, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Koezuka', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tochiya', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohata', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tamanaha', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Son', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimabara', 'Affiliation': 'Department of, Adult Cardiac Surgery, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of, Adult Cardiac Surgery, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Department of, Preventive Cardiology, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kobayashi', 'Affiliation': 'Department of, Adult Cardiac Surgery, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hosoda', 'Affiliation': 'Departments of, Department of, Endocrinology and Metabolism, National Cerebral and Cardiovascular Centre, Suita, Osaka, Japan.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14084']
2733,32043288,Adding vitamin D3 to the dipeptidyl peptidase-4 inhibitor saxagliptin has the potential to protect β-cell function in LADA patients: A 1-year pilot study.,"AIMS


This trial was conducted to explore the protective effect on β-cell function of adding vitamin D3 to DPP-4 inhibitors to treat patients with latent autoimmune diabetes in adults (LADA).
METHODS


60 LADA patients were randomized to group A (n = 21) - conventional therapy with metformin (1-1.7 g/day) and/or insulin treatment; group B (n = 20) - saxagliptin (5 mg/day) plus conventional therapy; and group C (n = 19) - vitamin D3 (2000 IU/day) plus saxagliptin and conventional therapy for 12 months. Fasting and 2-hour postprandial blood samples were collected to measure blood glucose, glycosylated hemoglobin and C-peptide levels at baseline and after 3, 6 and 12 months of treatment.
RESULTS


During the 12 months of follow-up, the levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio) were maintained in group C. In contrast to those in group A and group B, FCP levels decreased significantly in group B, and CPI levels declined significantly in group A during the 1-year treatment (P < .05). Additionally, the levels of GADA titers in group C significantly decreased compared with those at baseline (P < .05), but no significant differences in GADA titers levels were detected in group A and group B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titers.
CONCLUSIONS


The data suggested that adding 2000 IU/day vitamin D3 to saxagliptin might preserve β-cell function in patients with LADA.",2020,"B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titres.
","['patients with LADA', 'Sixty LADA patients', 'LADA Patients']","['saxagliptin and conventional therapy', 'vitamin D3 to saxagliptin', 'conventional therapy with metformin', 'insulin treatment; group B (n\xa0=\xa020) - saxagliptin (5\u2009mg per day) plus conventional therapy', 'Vitamin D3 to the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin', 'vitamin D3 to DPP-4 inhibitors', 'vitamin D3']","['levels of GADA titres', 'levels of FCP, PCP, the CPI or GADA titres', 'CPI levels', 'FCP levels', 'levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio', 'GADA titres levels', 'β-cell function', 'blood glucose, glycosylated haemoglobin, and C-peptide levels', 'Fasting and 2-hour postprandial blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0130753', 'cui_str': 'calpain inhibitor 2'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.021763,"B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titres.
","[{'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xieyi', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Endocrinology, Heji Hospital Affiliated to Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3298']
2734,31111313,Additive effect of continuous adductor canal block and liposomal bupivacaine periarticular injection in total knee arthroplasty.,"BACKGROUND


Novel methods of postoperative analgesia for total knee arthroplasty (TKA) have demonstrated improved functional outcomes and decreased narcotic consumption. These approaches include continuous adductor canal blocks (CACB) and periarticular injection (PAI). There is a lack of current understanding regarding the effect of these modalities on narcotic usage, functionality, and pain when both PAI and CACB are utilized compared to PAI alone.
METHODS


TKAs were performed unilaterally by a single surgeon with a standardized protocol. Patients were divided into two groups: those receiving PAI alone (n = 54) and those receiving PAI and CACB (n = 37). Patient outcomes including, narcotics usage, pain scale, and distance walked, were recorded on postoperative day (POD) zero through three.
RESULTS


When compared with PAI alone, it was identified that concurrent use of PAI and CACB results in a statistically significant decrease in narcotics usage on POD 0, 1, 3, and total narcotic usage while admitted. Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3. On POD 0, patients in the PAI and CACB reported significantly less pain with activity when compared to the PAI only group.
CONCLUSION


Here we identify an additive effect when utilizing both PAI and CACB for postoperative TKA analgesia. Our findings demonstrate significant decrease in patient total narcotic usage, pain scores, and an increase in walking distance when utilizing PAI and CACB compared with PAI alone. This analgesic technique may help reduce patients' narcotic use while also increasing functional outcomes.",2019,"Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3.","['TKAs were performed unilaterally by a single surgeon with a standardized protocol', 'total knee arthroplasty', 'total knee arthroplasty (TKA']","['continuous adductor canal blocks (CACB) and periarticular injection (PAI', 'PAI and CACB', 'PAI alone', 'CACB', 'continuous adductor canal block and liposomal bupivacaine periarticular injection']","['walking distance', 'narcotics usage on POD 0, 1, 3, and total narcotic usage', 'pain with activity', 'patient total narcotic usage, pain scores', 'narcotics usage, pain scale, and distance walked, were recorded on postoperative day (POD) zero through three']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394854', 'cui_str': 'Periarticular injection (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]",,0.0296591,"Patients in the PAI and CACB group walked significantly farther than patients in the PAI only group on POD 1, 2, and 3.","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Green', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Frane', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA. maxganz10@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stockton', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Stapleton', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mallen', 'Affiliation': 'Department of Orthopedics, Northwell Health Plainview Hospital, 888 Old Country Rd, Plainview, NY, 11803, USA.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02452-0']
2735,31119383,Blood loss reduction: effect of different knee prosthesis designs and use of tranexamic acid-a randomized controlled trial.,"PURPOSE


In regard to blood loss in total knee arthroplasty (TKA), the effect of either knee prosthesis designs or bone preparation is still unclear. While the benefit of using tranexamic acid (TXA) is well demonstrated, our study aims to determine the effect of different knee prosthesis designs uses and efficacy of blood loss reduction by different routes of TXA administration.
METHODS


The 228 patients undergone primary TKA were randomized to determine between open-box and closed-box prosthesis. Among each group, a second randomization was applied to categorize the patients into (1) no use of TXA (No-TXA), (2) intra-articular TXA use (IA-TXA) and (3) intravenous TXA use (IV-TXA). The calculated blood loss (CBL), drain volume (DV) and an average number of units of blood transfused (ANUBT) were blindly evaluated.
RESULTS


The open-box TKA had 85.60 and 63.29 ml (p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA. The IA-TXA and IV-TXA significantly reduced CBL by 190.75 and 162.01 ml (p < 0.01 and p < 0.01) and reduced DV by 129.07 and 61.04 ml (p < 0.01 and p = 0.01), respectively, when compared to No-TXA. Patients who received IA and IV-TXA had ANUBT of 0.21 and 0.23 unit, which was significantly lower than 0.42 unit of No-TXA group (p = 0.03).
CONCLUSIONS


Use of the different prosthesis designs could significantly affect CBL and DV following TKA. However, the use of either design resulted in a comparable ANUBT. Regardless of prosthetic type, either IA- or IV-TXA could significantly reduce the CBL and ANUBT when compared to No-TXA.",2019,(p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA.,"['228 patients undergone primary TKA', 'total knee arthroplasty (TKA']","['TXA (No-TXA), (2) intra-articular TXA use (IA-TXA) and (3) intravenous TXA use (IV-TXA', 'tranexamic acid', 'IA and IV-TXA', 'tranexamic acid (TXA', 'open-box and closed-box prosthesis', 'IA- or IV-TXA', 'IA-TXA and IV-TXA']","['CBL and DV', 'CBL', 'reduced DV', 'CBL and ANUBT', 'calculated blood loss (CBL), drain volume (DV) and an average number of units of blood transfused (ANUBT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449961', 'cui_str': 'Number of units (qualifier value)'}, {'cui': 'C0005768'}]",228.0,0.0392803,(p = 0.02 and p < 0.01) more CBL and DV compared to closed-box TKA.,"[{'ForeName': 'Artit', 'Initials': 'A', 'LastName': 'Laoruengthana', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Piti', 'Initials': 'P', 'LastName': 'Rattanaprichavej', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand. pt-rp@hotmail.com.'}, {'ForeName': 'Nattharut', 'Initials': 'N', 'LastName': 'Chaibhuddanugul', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Panapol', 'Initials': 'P', 'LastName': 'Varakornpipat', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Monton', 'Initials': 'M', 'LastName': 'Galassi', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, 99 Moo 9 Thapho, Phitsanulok, 65000, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Pongpirul', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-019-02450-2']
2736,30890624,Adapalene Gel 0.1% Versus Placebo as Prophylaxis for Anti-Epidermal Growth Factor Receptor-Induced Acne-Like Rash: A Randomized Left-Right Comparative Evaluation (APPEARANCE).,"LESSONS LEARNED


The results of the APPEARANCE trial indicate that adapalene does not prevent acne-like rash over placebo when added to topical moisturizer and oral minocycline but instead may have a detrimental effect. Therefore, adapalene is not recommended as prophylaxis against acne-like rash induced by anti-epidermal growth factor receptor therapies.Given that acne-like rash was completely controlled with placebo in approximately half of patients, predictive measures to identify patients needing intensive prophylaxis are required.
BACKGROUND


Anti-epidermal growth factor receptor (EGFR) therapies are frequently associated with acne-like rash. To evaluate the prophylactic efficacy of adapalene, a topical retinoid used as first-line therapy for acne vulgaris, we conducted a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial.
METHODS


Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies were randomly assigned to once-daily adapalene application on one side of the face, with placebo on the other side. All patients had topical moisturizer coapplied to both sides of the face, and received oral minocycline. The primary endpoint was the difference in total facial lesion count of acne-like rash at 4 weeks. Secondary endpoints included complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0-4) at 4 weeks. Two blinded dermatologists independently evaluated the endpoints from photographs.
RESULTS


A total of 36 patients were enrolled, of whom 26 were evaluable. Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8,  p  = .12). All four patients with a difference >10 in lesion count between face sides had a greater count on the adapalene-treated side. No significant differences were observed in CCR of acne-like rash (54% vs. 50%) or IGA scale (mean grade, 1.9 vs. 1.7) between the adapalene and placebo sides.
CONCLUSION


Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.",2019,"Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8,  p  = .12).","['Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies', 'A total of 36 patients were enrolled, of whom 26 were evaluable']","['adapalene', 'placebo', 'Adapalene Gel 0.1% Versus Placebo', 'adapalene application', 'Adapalene', 'minocycline']","['total facial lesion count of acne-like rash', 'prophylactic efficacy', ""complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0-4"", 'IGA scale', 'lesion count', 'CCR of acne-like rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0165631', 'cui_str': 'adapalene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0743775', 'cui_str': 'Facial lesion'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0222045'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",36.0,0.141643,"Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8,  p  = .12).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Chayahara', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Mukohara', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan tmukohar@east.ncc.go.jp.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fujishima', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fukunaga', 'Affiliation': 'Division of Dermatology, Department of Internal related, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Washio', 'Affiliation': 'Division of Dermatology, Department of Internal related, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takenaka', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Toyoda', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Tobimatsu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hisayo', 'Initials': 'H', 'LastName': 'Doi', 'Affiliation': 'Department of Nursing, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Mizuta', 'Affiliation': 'Department of Hospital Pharmacy, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Marugami', 'Affiliation': 'Department of Hospital Pharmacy, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Nishigori', 'Affiliation': 'Division of Dermatology, Department of Internal related, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",The oncologist,['10.1634/theoncologist.2019-0156']
2737,31113752,Effect of oral ursodeoxycholic acid on cholelithiasis following laparoscopic sleeve gastrectomy for morbid obesity.,"BACKGROUND


Laparoscopic sleeve gastrectomy (LSG) is a definitive solution for morbid obesity and its related co-morbidities. Cholelithiasis is a postoperative complication of LSG. The use of ursodeoxycholic acid (UDCA) after LSG is a proposed solution to reduce the incidence of cholelithiasis.
OBJECTIVE


To evaluate the effect of UDCA prophylaxis on cholelithiasis following LSG in morbidly obese patients.
SETTING


Two university hospitals in Egypt, Cairo, and Beni Suef Universities' hospitals.
METHODS


This prospective study was conducted between July 2015 and March 2018 and included 200 patients scheduled for LSG. They were randomly divided into 2 groups. The UDCA group received a postoperative prophylaxis regimen for prevention of cholelithiasis in the form of 250 mg twice daily of UDCA for 6 months. The control group did not receive prophylactic treatment. Abdominal ultrasound was done at 3, 6, 9, and 12 months for all patients to detect cholelithiasis. The primary outcome measure was cholelithiasis.
RESULTS


Only 6% of the UDCA group developed cholelithiasis compared with 40% in the control group (P < .001). Age, sex, initial body mass index, and excess weight loss at 6 months did not significantly affect cholelithiasis.
CONCLUSION


UDCA treatment for 6 months after LSG is effective in the prevention of cholelithiasis.",2019,Only 6% of the UDCA group developed cholelithiasis compared with 40% in the control group (P < .001).,"[""Two university hospitals in Egypt, Cairo, and Beni Suef Universities' hospitals"", 'morbidly obese patients', 'cholelithiasis following laparoscopic sleeve gastrectomy for morbid obesity', 'July 2015 and March 2018 and included 200 patients scheduled for LSG']","['oral ursodeoxycholic acid', 'ursodeoxycholic acid (UDCA', 'UDCA', 'Laparoscopic sleeve gastrectomy (LSG', 'UDCA prophylaxis']",['cholelithiasis'],"[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}]",200.0,0.0335611,Only 6% of the UDCA group developed cholelithiasis compared with 40% in the control group (P < .001).,"[{'ForeName': 'Tamer M', 'Initials': 'TM', 'LastName': 'Nabil', 'Affiliation': 'Department of General Surgery, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Khalil', 'Affiliation': 'Department of General Surgery, Cairo University, Giza, Egypt. Electronic address: dr_ahmedhussein76@yahoo.com.'}, {'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Gamal', 'Affiliation': 'Department of Reproductive Health, National Research Center, Dokki, Egypt.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.03.028']
2738,32085706,Efficacy of web-assisted self-help for parents of children with ADHD (WASH) - a three-arm randomized trial under field/routine care conditions in Germany.,"BACKGROUND


Current clinical guidelines recommend parent management training (PMT) in the treatment of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD). However, (a) a lack of supply and (b) structural barriers to attending and continuing face-to-face PMT restrict the access to this training. The main purpose of this study is to investigate the efficacy of online PMT in decreasing ADHD symptoms and oppositional behavior problems and to evaluate the effects of additional telephone-based support of the parents.
METHODS


The target sample size is n = 495 children with suspected or even clinical diagnosis of ADHD and current symptoms of ADHD or ODD. The study is based on a randomized three-arm parallel group design, in which the effects of treatment as usual (TAU) are compared to TAU plus web-assisted self-help (TAU+WASH) and to TAU plus web-assisted self-help and telephone-based support (TAU+WASH+SUPPORT).
DISCUSSION


The results will provide important insights into the efficacy of web-assisted self-help for parents of children with ADHD and the additional effects of telephone-based support.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS) DRKS00013456. January 3rd 2018. World Health Organization Trial Registration Data Set: Universal Trial number (UTN) U1111-1205-6181. November 23rd 2017.",2020,"The results will provide important insights into the efficacy of web-assisted self-help for parents of children with ADHD and the additional effects of telephone-based support.
","['parents of children with ADHD (WASH) - a three-arm randomized trial under field/routine care conditions in Germany', '495 children with suspected or even clinical diagnosis of ADHD and current symptoms of ADHD or ODD']","['TAU plus web-assisted self-help (TAU+WASH) and to TAU plus web-assisted self-help and telephone-based support (TAU+WASH+SUPPORT', 'web-assisted self-help', 'parent management training (PMT', 'online PMT']",['ADHD symptoms and oppositional behavior problems'],"[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0647195', 'cui_str': 'PMTS'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",495.0,0.164611,"The results will provide important insights into the efficacy of web-assisted self-help for parents of children with ADHD and the additional effects of telephone-based support.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Döpfner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany. manfred.doepfner@uk-koeln.de.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wähnke', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), University of Cologne, Faculty of Medicine and University Hospital Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Marie-Theres', 'Initials': 'MT', 'LastName': 'Klemp', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), University of Cologne, Faculty of Medicine and University Hospital Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Mühlenmeister', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), University of Cologne, Faculty of Medicine and University Hospital Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schürmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Plück', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), University of Cologne, Faculty of Medicine and University Hospital Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-2481-0']
2739,32101271,Effects of Antipsychotic Medication on Brain Structure in Patients With Major Depressive Disorder and Psychotic Features: Neuroimaging Findings in the Context of a Randomized Placebo-Controlled Clinical Trial.,"Importance


Prescriptions for antipsychotic medications continue to increase across many brain disorders, including off-label use in children and elderly individuals. Concerning animal and uncontrolled human data suggest antipsychotics are associated with change in brain structure, but to our knowledge, there are no controlled human studies that have yet addressed this question.
Objective


To assess the effects of antipsychotics on brain structure in humans.
Design, Setting, and Participants


Prespecified secondary analysis of a double-blind, randomized, placebo-controlled trial over a 36-week period at 5 academic centers. All participants, aged 18 to 85 years, were recruited from the multicenter Study of the Pharmacotherapy of Psychotic Depression II (STOP-PD II). All participants had major depressive disorder with psychotic features (psychotic depression) and were prescribed olanzapine and sertraline for a period of 12 to 20 weeks, which included 8 weeks of remission of psychosis and remission/near remission of depression. Participants were then were randomized to continue receiving this regimen or to be switched to placebo and sertraline for a subsequent 36-week period. Data were analyzed between October 2018 and February 2019.
Interventions


Those who consented to the imaging study completed a magnetic resonance imaging (MRI) scan at the time of randomization and a second MRI scan at the end of the 36-week period or at time of relapse.
Main Outcomes and Measures


The primary outcome measure was cortical thickness in gray matter and the secondary outcome measure was microstructural integrity of white matter.
Results


Eighty-eight participants (age range, 18-85 years) completed a baseline scan; 75 completed a follow-up scan, of which 72 (32 men and 40 women) were useable for final analyses. There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area. No significant interaction was found for fractional anisotropy, but one for mean diffusivity of the white matter skeleton was present (t = -2.6, P = .01). When the analysis was restricted to those who sustained remission, exposure to olanzapine compared with placebo was associated with significant decreases in cortical thickness in the left hemisphere (β [SE], 0.04 [0.009]; t34.4 = 4.7; P <.001), and the right hemisphere (β [SE], 0.03 [0.009]; t35.1 = 3.6; P <.001). Post hoc analyses showed that those who relapsed receiving placebo experienced decreases in cortical thickness compared with those who sustained remission.
Conclusions and Relevance


In this secondary analysis of a randomized clinical trial, antipsychotic medication was shown to change brain structure. This information is important for prescribing in psychiatric conditions where alternatives are present. However, adverse effects of relapse on brain structure support antipsychotic treatment during active illness.
Trial Registration


ClinicalTrials.gov Identifier: NCT01427608.",2020,"There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area.","['Patients With Major Depressive Disorder and Psychotic Features', 'Eighty-eight participants (age range, 18-85 years) completed a baseline scan; 75 completed a follow-up scan, of which 72 (32 men and 40 women', 'humans', 'children and elderly individuals', 'All participants had major depressive disorder with psychotic features (psychotic depression', 'All participants, aged 18 to 85 years, were recruited from the multicenter Study of the Pharmacotherapy of Psychotic Depression II (STOP-PD II']","['Antipsychotic Medication', 'placebo', 'magnetic resonance imaging (MRI) scan', 'placebo and sertraline', 'antipsychotics', 'olanzapine', 'olanzapine and sertraline', 'Placebo']","['cortical thickness in gray matter', 'mean diffusivity of the white matter skeleton', 'right hemisphere', 'cortical thickness', 'time interaction in cortical thickness', 'remission of psychosis and remission/near remission of depression', 'microstructural integrity of white matter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0816871', 'cui_str': 'Skeleton'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]",,0.436468,"There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area.","[{'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin W', 'Initials': 'EW', 'LastName': 'Dickie', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Neufeld', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'UMass Memorial Health Care, University of Massachusetts Medical School, Worcester.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Whyte', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Meyers', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hoptman', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, Orangeburg, New York.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Lerch', 'Affiliation': 'Mouse Imaging Centre, The Hospital for Sick Children, Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'University Health Network, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0036']
2740,31357259,Aerobic Training Performed at Ventilatory Threshold Improves Psychological Outcomes in Adolescents With Obesity.,"BACKGROUND


Physical activity may be as effective as some drugs for improving psychological outcomes; however, vigorous exercise may be needed for improving these outcomes in adolescents with obesity. The aim of this study is to examine the effects of low- and high-intensity training on self-esteem and symptoms of depression and anxiety in adolescents with obesity.
METHODS


A total of 62 pubertal adolescents with obesity (age 15 [1.5] y, body mass index 34.87 [4.22] kg/m2) were randomized into high-intensity group (HIG, n = 31) or low-intensity group (LIG, n = 31) for 24 weeks. All participants also received nutritional, psychological, and clinical counseling. Body composition and measures of depressive symptoms, anxiety, and self-esteem were assessed at baseline and after 24 weeks.
RESULTS


Depressive symptoms decreased significantly in both HIG (d = 1.16) and LIG (d = 0.45) (P ≤ .01). Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002). No changes were observed in state anxiety or self-esteem.
CONCLUSIONS


Results from the present study demonstrate that 24 weeks of multidisciplinary intervention improves depression and anxiety symptoms in adolescents with obesity; however, the magnitude of changes is higher in HIG compared with LIG.",2019,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","['adolescents with obesity', '62 pubertal adolescents with obesity (age 15 [1.5]\xa0y, body mass index 34.87 [4.22]\xa0kg/m2', 'Adolescents With Obesity']","['Aerobic Training Performed at Ventilatory Threshold', 'low- and high-intensity training', 'multidisciplinary intervention']","['Psychological Outcomes', 'self-esteem and symptoms of depression and anxiety', 'Trait anxiety', 'Depressive symptoms', 'depression and anxiety symptoms', 'Body composition and measures of depressive symptoms, anxiety, and self-esteem', 'state anxiety or self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",62.0,0.0340544,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","[{'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Fidelix', 'Affiliation': ''}, {'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Lofrano-Prado', 'Affiliation': ''}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': ''}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'do Prado', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0193']
2741,31315939,Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction.,"OBJECTIVE


The Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy.
METHODS


Patients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure.
RESULTS


From March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62).
CONCLUSIONS


In this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy.
TRIAL REGISTRATION NUMBER


NCT01435408.",2020,There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004).,"['1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months', 'patients included in DANAMI-3-iPOST stratified by the use of thrombectomy', 'Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST', 'From March 2011 until February 2014', 'patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning', 'patients with ST-elevation myocardial infarction', 'Patients with STEMI']","['ischaemic postconditioning and thrombectomy', 'conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI', 'ischaemic postconditioning']",['combination of all-cause mortality and hospitalisation for heart failure'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1234.0,0.0824787,There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004).,"[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nepper-Christensen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans-Henrik', 'Initials': 'HH', 'LastName': 'Tilsted', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Joshi', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Sørensen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bang', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Catheterisation Lab, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-314952']
2742,31375462,Variations in Marginal Taste Perception by Body Mass Index Classification: A Randomized Controlled Trial.,"BACKGROUND


The propensity to overeat may, in part, be a function of the satisfaction derived from eating. If levels of satisfaction derived from food differ among normal-weight, overweight, and obese adults, the quantification of satisfaction from food may help explain why some people eat more than others.
OBJECTIVE


To quantify the satisfaction obtained from eating one specific food, chocolate, by measuring taste perception as normal-weight, overweight, and obese participants consumed additional pieces of chocolate. To measure the effect of nutritional information on chocolate consumption.
DESIGN


Randomized, controlled trial.
PARTICIPANTS/SETTING


We analyzed data on 290 adults; 161 had a body mass index (BMI) that was considered normal (<25), 78 had a BMI considered overweight (≥25 and <30), and 51 had a BMI considered obese (≥30).
INTERVENTION


Participants were given samples of chocolate, one at a time, until they chose to stop eating. With each sample, participants were given a questionnaire. Half of the study participants were randomly selected to receive nutritional information (n=150).
MAIN OUTCOME MEASURES


Perceived taste for each sample.
STATISTICAL ANALYSES PERFORMED


We used time-series-regression to model perceived taste changes while controlling for participant characteristics.
RESULTS


Study participants consumed between 2 and 51 pieces of chocolate with a mean of 12.1 pieces. Average taste perception decreased with each piece. We found no significant difference in taste perceptions between normal- and overweight participants. However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02). Also, obese participants reported taste perceptions that declined at a more gradual rate than normal- and overweight participants (P<0.01). Self-reported hunger, prior to the study, affected taste perception, but providing nutritional information did not.
CONCLUSIONS


Obese participants started with higher levels of perceived taste and also experienced slower rates of decline than did normal-weight and overweight individuals.",2020,"However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02).","['290 adults; 161 had a body mass index (BMI) that was considered normal (<25), 78 had a BMI considered overweight (≥25 and <30), and 51 had a BMI considered obese (≥30']",['nutritional information'],"['initial taste perception', 'Marginal Taste Perception by Body Mass Index Classification', 'gradual rate', 'Average taste perception', 'taste perceptions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2350521', 'cui_str': 'Gustatory Perception'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}]",290.0,0.102231,"However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02).","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': ''}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Segre', 'Affiliation': ''}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.018']
2743,31630398,Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial.,"INTRODUCTION


Approximately 4% of singleton pregnancies at term are in breech presentation. External cephalic version (ECV) can reduce the risks of noncephalic birth and cesarean delivery, but this maneuver can be painful. Our aim was to analyze the effect of administering inhaled nitrous oxide for analgesia on the ECV success rate.
MATERIAL AND METHODS


This prospective, randomized, single-blind, controlled trial included women with singleton pregnancies in breech presentation at term who were referred for ECV in a tertiary care center. Women were assigned according to a balanced (1:1) restricted randomization design to inhale either nitrous oxide (N 2  O) in a 50:50 mix with oxygen or medical air during the procedure. The main outcomes reported are the ECV success rate, degree of pain, adverse event rate, and women's satisfaction.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01948115.
RESULTS


The study included 150 women (nitrous oxide group: n = 74; medical air: n = 76). Inhaled nitrous oxide was not associated with a higher ECV success rate than medical air (24.3 vs 19.7%, P = 0.51). Among parous women (n = 34 in each group), the ECV success rate appeared higher in the nitrous oxide group, respectively 47.1% (n = 16) vs 23.5% (n = 8) (P = 0.042). Neither the median pain level nor adverse event rates differed significantly in women with inhaled nitrous oxide compared with medical air.
CONCLUSIONS


Use of an equimolar mixture of oxygen and nitrous oxide during ECV appears safe. Although it does not seem to change the overall success rate, it may increase success in parous women.",2020,"Inhaled nitrous oxide was not associated with a higher ECV success rate than medical air (24.3% vs. 19.7%, P=0.51).","['women with singleton pregnancies in breech presentation at term who were referred for ECV in a tertiary care center', 'parous women', '150 women (nitrous oxide group: n=74; medical air: n=76']","['nitrous oxide (N 2  O) in a 50:50 mix with oxygen or medical air during the procedure', 'Inhaled nitrous oxide', 'equimolar mixture of oxygen and nitrous oxide', 'nitrous oxide', 'External cephalic version (ECV', 'inhaled nitrous oxide']","['ECV success rate', ""ECV success rate, degree of pain, adverse event rate, and women's satisfaction"", 'success rate', 'median pain level nor adverse event rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0006157', 'cui_str': 'Labor Presentation, Breech'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3536832', 'cui_str': 'medical air'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3536832', 'cui_str': 'medical air'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0410877', 'cui_str': 'Version, External Cephalic'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",150.0,0.14746,"Inhaled nitrous oxide was not associated with a higher ECV success rate than medical air (24.3% vs. 19.7%, P=0.51).","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dochez', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Esbelin', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Misbert', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Arthuis', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Drouard', 'Affiliation': 'Clinical Investigation Center (CIC), University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Badon', 'Affiliation': 'Clinical Investigation Center (CIC), University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fenet', 'Affiliation': 'Biometrics and Biostatistics Platform, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Thubert', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Winer', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of Nantes, Nantes, France.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13753']
2744,31371154,Haemostasis in oral surgical procedures involving patients with a ventricular assist device.,"The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required.",2019,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","['patients with VADs, while the third group included cardiovascular patients without VADs who served as controls', 'patients undergoing oral surgery', 'patients with ventricular assist devices (VADs', 'patients with a ventricular assist device']","['local anaesthesia without sedation', 'topical haemostatic agents (oxidized cellulose or collagen', 'fibrin glue']","['incidence of haemorrhage', 'haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0222906,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany. Electronic address: hamzah@medizin.uni-leipzig.de.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Graf', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Kaluđerović', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany; Practice for Maxillofacial Surgery, Lepsiusstraße 2, 06618 Naumburg, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Meyer', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Dieterlen', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemprich', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.07.009']
2745,32071038,The effect of training GPs in motivational interviewing on incident cardiovascular disease and mortality in people with screen-detected diabetes. Results from the ADDITION-Denmark randomised trial.,"BACKGROUND


There is no long-term evidence on the effectiveness of training for motivational interviewing in diabetes treatment.
AIM


Within a trial of intensive treatment of people with screen-detected diabetes, which included training in motivational interviewing for GPs, the study examined the effect of the intervention on incident cardiovascular disease (CVD) and all-cause mortality.
DESIGN & SETTING


In the ADDITION-Denmark trial, 181 general practices were cluster randomised in a 2:1:1 ratio to: (i) to screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group). The study took place from 2001-2009.
METHOD


After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
RESULTS


Compared with the routine care group, the risk of CVD was similar in the intensive treatment group (hazard ratio [HR] 1.11, 95% confidence interval [CI] = 0.82 to 1.50) and the intensive treatment plus motivational interviewing group (HR 1.26, 95% CI = 0.96 to 1.64). The incidence of death was similar in all three treatment groups.
CONCLUSION


Training of GPs in intensive multifactorial treatment, with or without motivational interviewing, was not associated with a reduction in mortality or CVD among those with screen-detected diabetes.",2020,"After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
","['people with screen-detected diabetes', '181 general practices']","['screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group', 'training GPs in motivational interviewing']","['rates of first fatal and non-fatal CVD events and all-cause mortality', 'incidence of death', 'incident cardiovascular disease (CVD', 'mortality or CVD', 'risk of CVD']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",181.0,0.0678224,"After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Charles', 'Affiliation': 'Senior Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark Mc@ph.au.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Bruun', 'Affiliation': 'Senior Biostatistician, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Simmons', 'Affiliation': 'Visiting Senior Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Post-doctoral Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Witte', 'Affiliation': 'Professor, Danish Diabetes Academy, Odense, Denmark.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Jorgensen', 'Affiliation': 'Professor, Clinical Epidemiology, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Helle Terkildsen', 'Initials': 'HT', 'LastName': 'Maindal', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Rubak', 'Affiliation': 'Clinical Associate Professor, Center for Pediatric Pulmonology and Allergology, Department of Child and Youth, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Head of Unit for Cross-sectoral Collaboration and Integrated Patient Care, Steno Diabetes Center Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}]",BJGP open,['10.3399/bjgpopen20X101012']
2746,32065485,Efficacy of chlorhexidine patches on central line-associated bloodstream infections in children.,"BACKGROUND


Central line-associated bloodstream infections (CLABSIs) are important hospital-acquired infections. Chlorhexidine-impregnated dressings (also known as chlorhexidine patches, CHG patches) are reported to decrease CLABSIs in adults. This study aims to determine the efficacy of CHG patches in reducing CLABSIs in children.
METHODS


An open-label randomized controlled trial was conducted in children aged 2 months to 18 years, requiring a short-term catheter. Patients were randomized into two groups, allocated to receive CHG patches or standard transparent dressings. Care of the catheter was in accordance with Asia Pacific Society of Infection Control (APSIC) recommendations. Central-line-associated bloodstream infections were defined using National Healthcare Safety Network surveillance criteria.
RESULTS


From April 2017 to April 2018, 192 children were enrolled. There were 108 CHG patch catheters and 101 standard dressing catheters, contributing to 3,113 catheter days. The median duration of catheter dwelling was 13 days, with an interquartile range (IQR) of 8-20 days. Half were placed at the jugular vein and 22% at the femoral vein. There were 23 CLABSI events. Incidence rates for CHG patches and standard dressings were 7.98 (95% confidence interval (CI), 4.25-13.65) and 6.74 (95% CI, 3.23-12.39) per 1,000 catheter days, respectively (incidence rate ratio 1.18; 95% CI, 0.52-2.70). The CLABSI pathogens were 15 Gram-negative bacteria, six Gram-positive bacteria, and two Candida organisms. Catheter colonization of CHG patches and standard dressings were 2.02 (95% CI, 0.42-5.91) and 3.07 (95% CI, 1.00-7.16) per 1,000 catheter days, respectively. Only local adverse effects occurred in 6.8% of the participants.
CONCLUSIONS


In our setting, there was no difference in CLABSI rates when the chlorhexidine patch dressings were compared with the standard transparent dressings. Strengthening of CLABSI prevention bundles is mandatory.",2020,"Catheter colonization of CHG-patches and standard dressings were 2.02 (95% CI, 0.42-5.91) and 3.07 (95% CI, 1.00-7.16) per 1000 catheter-days, respectively.","['From April 2017 to April 2018, 192 children were enrolled', 'children aged 2 months to 18 years requiring a short-term catheter', 'children']","['Chlorhexidine-impregnated dressings', 'chlorhexidine patch', 'CHG-patches or standard transparent dressings', 'CHG-patches']","['central line-associated bloodstream infections', 'median duration of catheter dwelling', 'Incidence rates', 'CLABSI rates', 'Catheter colonization of CHG-patches and standard dressings', 'local adverse effects']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1272974', 'cui_str': 'Impregnated dressing'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0770788', 'cui_str': 'Transparent dressing (physical object)'}]","[{'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",192.0,0.129444,"Catheter colonization of CHG-patches and standard dressings were 2.02 (95% CI, 0.42-5.91) and 3.07 (95% CI, 1.00-7.16) per 1000 catheter-days, respectively.","[{'ForeName': 'Nattapong', 'Initials': 'N', 'LastName': 'Jitrungruengnij', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanapoom', 'Initials': 'T', 'LastName': 'Rattananupong', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Prinyawat', 'Affiliation': 'Infection Control Unit, Department of Nursing, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Watsamon', 'Initials': 'W', 'LastName': 'Jantarabenjakul', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Noppadol', 'Initials': 'N', 'LastName': 'Wacharachaisurapol', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Tanittha', 'Initials': 'T', 'LastName': 'Chatsuwan', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Janewongwirot', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pintip', 'Initials': 'P', 'LastName': 'Suchartlikitwong', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monta', 'Initials': 'M', 'LastName': 'Tawan', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Phavinee', 'Initials': 'P', 'LastName': 'Kanchanabutr', 'Affiliation': 'Department of Nursing, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Chitsanu', 'Initials': 'C', 'LastName': 'Pancharoen', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14200']
2747,31928551,"Hand hygiene promotion delivered by change agents-Two attitudes, similar outcome.","OBJECTIVE


To assess the effect of peer-identified change agents (PICAs) compared to management-selected change agents (MSCAs) on hand hygiene behavior in acute care.
DESIGN


Randomized-controlled study.
SETTING


Two internal medicine wards of a public, university-affiliated, tertiary-care hospital in Malaysia.
METHODS


We randomly allocated 2 wards to hand hygiene promotion delivered either by PICAs (study arm 1) or by MSCAs (study arm 2). The primary outcome was hand hygiene compliance using direct observation by validated auditors. Secondary outcomes were hand hygiene knowledge and observations from ward tours.
RESULTS


Mean hand hygiene compliance in study arm 1 and study arm 2 improved from 48% (95% confidence interval [CI], 44%-53%) and 50% (95% CI, 44%-55%) in the preintervention period to 66% (63%-69%) and 65% (60%-69%) in the intervention period, respectively. We detected no statistically significant difference in hand hygiene improvement between the 2 study arms. Knowledge scores on hand hygiene in study arm 1 and study arm 2 improved from 60% and 63% to 98% and 93%, respectively. Staff in study arm 1 improved hand hygiene because they did not want to disappoint the efforts taken by the PICAs. Staff in study arm 2 felt pressured by the MSCAs to comply with hand hygiene to obtain good overall performance appraisals.
CONCLUSION


Although the attitude of PICAs and MSCAs in terms of leadership, mode of action and perception of their task by staff were very different, or even opposed, both PICAs and MSCAs effectively changed behavior of staff toward improved hand hygiene to comparable levels.",2020,"Knowledge scores on hand hygiene in study arm 1 and study arm 2 improved from 60% and 63% to 98% and 93%, respectively.","['Two internal medicine wards of a public, university-affiliated, tertiary-care hospital in Malaysia']","['peer-identified change agents (PICAs', 'management-selected change agents (MSCAs', 'hand hygiene promotion delivered either by PICAs (study arm 1) or by MSCAs']","['hand hygiene compliance using direct observation by validated auditors', 'Mean hand hygiene compliance', 'hand hygiene knowledge and observations from ward tours', 'Knowledge scores on hand hygiene', 'hand hygiene improvement']","[{'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0334975', 'cui_str': 'Auditor (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.115623,"Knowledge scores on hand hygiene in study arm 1 and study arm 2 improved from 60% and 63% to 98% and 93%, respectively.","[{'ForeName': 'Yew Fong', 'Initials': 'YF', 'LastName': 'Lee', 'Affiliation': 'Institute of Global Health, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Mary-Louise', 'Initials': 'ML', 'LastName': 'McLaws', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Loke Meng', 'Initials': 'LM', 'LastName': 'Ong', 'Affiliation': 'Clinical Research Centre & Department of Medicine, Hospital Pulau Pinang, Georgetown, Malaysia.'}, {'ForeName': 'Suraya', 'Initials': 'S', 'LastName': 'Amir Husin', 'Affiliation': 'Ministry of Health, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hock Hin', 'Initials': 'HH', 'LastName': 'Chua', 'Affiliation': 'Sarawak General Hospital, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'See Yin', 'Initials': 'SY', 'LastName': 'Wong', 'Affiliation': 'Sarawak General Hospital, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': 'Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zingg', 'Affiliation': 'Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.339']
2748,31367914,"Efficacy of F-100, diluted F-100, and infant formula as rehabilitation diet for infants aged < 6 months with severe acute malnutrition: a randomized clinical trial.","PURPOSE


To assess the efficacy and safety of F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management in the rehabilitation phase of severe acute malnutrition (SAM) of infants aged under 6 months (u6m).
METHODS


Double-blind randomized clinical trial was conducted to assess the efficacy and safety of F-100, F-100D, and IF at the Nutrition Rehabilitation Unit, icddr,b. Infants (n = 153) u6m with SAM were enrolled and randomly assigned to any of the three diets after stabilization. Two ml blood was collected on study days 1, 3, and 7 for measuring serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio. Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL) were calculated. Infants were discharged when gained 15% of the admission bodyweight or had edema-free weight-for-length Z-score ≥ - 2.
RESULTS


Infants fed F-100 and F-100D had higher weight gain than infants who received IF. Mean difference between F-100 and IF was 4.6 g/kg/d (95% CI 1.5-7.6, P = 0.004) and between F-100D and IF was 3.1 g/kg/d (95% CI 0.6-5.5, P = 0.015). Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case). RSL was highest in infants fed F-100 but serum sodium showed no sign of elevation. Urinary specific gravity and serum sodium values were within normal range.
CONCLUSIONS


F-100 can be safely used in the rehabilitation phase for infants  u6m with SAM and there is no need to prepare alternative formulations.",2020,Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case).,"['severe acute malnutrition (SAM) of infants aged under 6\xa0months\xa0(u6m', 'infants aged\u2009<\u20096\xa0months with severe acute malnutrition', '153) u6m\xa0with SAM', 'Infants (n\u2009', 'infants']","['F-100, diluted F-100, and infant formula as rehabilitation diet', 'F-100, diluted F-100 (F100D), and infant formula (IF) for dietary management']","['RSL', 'Urinary specific gravity and serum sodium values', 'serum electrolytes, creatinine and osmolality, urine samples for specific gravity and osmolality creatinine ratio', 'efficacy and safety of F-100, F-100D, and IF', 'weight gain', 'Renal Solute Load (RSL) and Potential Renal Solute Load (PRSL', 'Total energy intake']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0037786', 'cui_str': 'Relative Density'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.242064,Total energy intake from study diet and breast milk was significantly higher in infants fed F-100 compared with other two diets (P = 0.001 in each case).,"[{'ForeName': 'M Munirul', 'Initials': 'MM', 'LastName': 'Islam', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh. mislam@icddrb.org.'}, {'ForeName': 'Sayeeda', 'Initials': 'S', 'LastName': 'Huq', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Md Iqbal', 'Initials': 'MI', 'LastName': 'Hossain', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}, {'ForeName': 'A M Shamsir', 'Initials': 'AMS', 'LastName': 'Ahmed', 'Affiliation': 'Primary Health Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashworth', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Md Abid Hossain', 'Initials': 'MAH', 'LastName': 'Mollah', 'Affiliation': 'Department of Paediatrics, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka, 1000, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, 1212, Bangladesh.'}]",European journal of nutrition,['10.1007/s00394-019-02067-5']
2749,31958285,"The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial.","OBJECTIVE


To assess the effect of upper limb exercise on hand function, daily activities performance and quality of life of patients with systemic lupus erythematosus (SLE).
METHODS


We performed a pilot randomised, 24-week follow-up, unmasked controlled trial. Inclusion criteria were upper limb arthralgias, a Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score >10 and a stable treatment over the past 3 months. Patients were randomly allocated in the routine care (control) or exercise group that received an individually tailored 30-min daily upper-limb exercise programme by a hand therapist for 12 weeks. We evaluated at 0, 6, 12 and 24 weeks the performance of daily activities for both groups with DASH questionnaire and Health Assessment Questionnaire (HAQ), the grip and pinch strength with Jamar dynamometer and pinch gauge tool, respectively, the dexterity with Purdue pegboard test, the quality of life with Lupus Quality of Life (LupusQoL) Questionnaire and the pain level by Visual Analogue Scale (VAS) score.
RESULTS


From 293 consecutive SLE patients, data from 32 patients allocated to the exercise group and 30 to the control group were analysed. There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001). No interaction was observed between exercise and disease activity or medication use at baseline and during the observation period.
CONCLUSION


Upper-limb exercise significantly improves hand function, pain, daily activity performance and quality of life in SLE.
TRIAL REGISTRATION NUMBER


NCT03802578.",2020,"There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001).","['293 consecutive SLE patients, data from 32 patients allocated to the exercise group and 30 to the control group were analysed', 'systemic lupus erythematosus', 'patients with systemic lupus erythematosus (SLE']","['upper limb exercise', 'routine care (control) or exercise group that received an individually tailored 30-min daily upper-limb exercise programme by a hand therapist for 12 weeks', 'Upper-limb exercise']","['function, daily activities and quality of life', 'hand function, pain, daily activity performance and quality of life', 'upper limb arthralgias, a Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score', 'DASH questionnaire and Health Assessment Questionnaire (HAQ), the grip and pinch strength with Jamar dynamometer and pinch gauge tool, respectively, the dexterity with Purdue pegboard test, the quality of life with Lupus Quality of Life (LupusQoL) Questionnaire and the pain level by Visual Analogue Scale (VAS) score', 'hand function, daily activities performance and quality of life', 'percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores']","[{'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}]","[{'cui': 'C0454320', 'cui_str': 'Upper limb exercises (regime/therapy)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0418416', 'cui_str': 'Pinched (event)'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0204462', 'cui_str': 'Purdue pegboard test (procedure)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",293.0,0.100951,"There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001).","[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Keramiotou', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Anagnostou', 'Affiliation': 'Rheumatology Unit, Thriasio General Hospital of Elefsina, Magoula, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Kataxaki', 'Affiliation': 'Rheumatology Unit, Thriasio General Hospital of Elefsina, Magoula, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Galanos', 'Affiliation': 'Laboratory for Research of Musculoskeletal System ""Theodoros Garofalidis"", National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Petros P', 'Initials': 'PP', 'LastName': 'Sfikakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Tektonidou', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Joint Rheumatology Program, Medical School, National and Kapodistrian University of Athens, Athens, Greece mtektonidou@gmail.com.'}]",RMD open,['10.1136/rmdopen-2019-001141']
2750,31673354,Acceptability and tolerability of alcohol-based hand hygiene products for elderly residents in long-term care: a crossover study.,"Background


Hand hygiene is a critical component of infection control. Much of the focus on improving hand hygiene in healthcare settings has been directed towards healthcare worker compliance but its importance for patients, including those in long-term care facilities (LTCFs), is increasingly being recognised. Alcohol-based hand rub (ABHR) can lead to improved compliance. We aimed to determine acceptability and tolerability of two ABHRs for hand hygiene of elderly LTCF residents using a modified version of the WHO protocol.
Methods


Thirty six elderly LTCF residents participated in this crossover study. A modified and translated (Chinese) version of the WHO protocol for evaluation of two or more ABHRs was used to determine product acceptability and tolerability for one gel (bottle with reclosable cap) and one foam (pump). During the 3-day testing period, participants were provided with their own portable bottle of ABHR. A research nurse objectively assessed the skin integrity of the hands at baseline and throughout the study. Skin moisture content was determined using a Scalar Moisture Checker Probe (Science Technology Resources, Ca, USA). Participants rated ABHR tolerability and acceptability using the WHO checklist at the end of each test period.
Results


Both products passed the WHO criteria for acceptability and tolerability. The foam (86%) scored higher than the gel (51%) for ease of use possibly because some participants found the cap of the gel bottle difficult to open due to finger stiffness. No evidence of damage to skin integrity was observed. Overall, skin moisture content had improved by the end of the study. Residents preferred either of the test products to the liquid formulation currently in use by the LTCF.
Conclusions


Overall, the elderly were willing to use ABHR for hand hygiene. Both products were well tolerated and preferred over the usual product provided by the LTCF. However, forgetfulness and difficulty rubbing the product over the hands due to finger stiffness posed a challenge for some residents. This could be overcome by using healthcare worker-assisted hand hygiene at specified times each day and prompts to serve as reminders to perform hand hygiene.",2019,The foam (86%) scored higher than the gel (51%) for ease of use possibly because some participants found the cap of the gel bottle difficult to open due to finger stiffness.,"['elderly residents in long-term care', 'six elderly LTCF residents', 'elderly LTCF residents using a modified version of the WHO protocol']","['Alcohol-based hand rub (ABHR', 'alcohol-based hand hygiene products']","['ABHR tolerability and acceptability', 'damage to skin integrity', 'acceptability and tolerability', 'skin integrity', 'Overall, skin moisture content', 'Acceptability and tolerability', 'Skin moisture content']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023977'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",36.0,0.0161889,The foam (86%) scored higher than the gel (51%) for ease of use possibly because some participants found the cap of the gel bottle difficult to open due to finger stiffness.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': ""O'Donoghue"", 'Affiliation': '1Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Jacqueline M C', 'Initials': 'JMC', 'LastName': 'Ho', 'Affiliation': '1Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': '2Infection Control Program and World Health Organization Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Lorna K P', 'Initials': 'LKP', 'LastName': 'Suen', 'Affiliation': '1Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-019-0610-7']
2751,31628006,Assessment of a University-Based Outpatient Asthma Education Program for Children.,"INTRODUCTION


To assess the effect of a pediatric asthma intervention program on reducing asthma morbidity.
METHODS


Study eligibility criteria included aged less than 18 years and at least two office visits for asthma in the previous year. Patients were randomly assigned to either the control or intent to intervene group. The intervention included home visits and education on the basic pathophysiology of asthma, self-management techniques, modification of asthma triggers, and proper use of asthma medications by a certified nurse educator.
RESULTS


Using simple randomization, 901 eligible pediatric patients with asthma were assigned; 458 to the control and 443 to the intent to intervene group. Of the 443 patients randomized to the intent to intervene group, 271 received the asthma education intervention. Most of the remaining 172 patients in the intent to intervene group did not receive the intervention owing to not having an appointment during the study period. Only 27 families allowed a home visit. After controlling for the difference in sex, children in the intent to intervene group had significantly less total clinic visits (incidence rate ratio [IRR] = 0.53, p < .01), and steroid bursts (IRR = 0.47, p < .01) than controls.
DISCUSSION


The implementation of a pediatric asthma education program decreased both the total clinic visits and the need for steroid bursts consistent with better asthma control. We demonstrated the benefit of a dedicated asthma educator in university-based community practice and recommend this intervention be considered a standard of care for children with asthma in all health-care settings.",2020,The implementation of a pediatric asthma education program decreased both the total clinic visits and the need for steroid bursts consistent with better asthma control.,"['children with asthma in all health-care settings', '901 eligible pediatric patients with asthma were assigned; 458 to the control and 443 to the intent to intervene group', 'Assessment of a University-Based Outpatient Asthma Education Program for Children', 'Study eligibility criteria included aged less than 18 years and at least two office visits for asthma in the previous year', '443 patients randomized to the intent to intervene group, 271 received the']","['asthma education intervention', 'pediatric asthma intervention program']","['total clinic visits', 'asthma morbidity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1679754', 'cui_str': 'Asthma education (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",901.0,0.0199935,The implementation of a pediatric asthma education program decreased both the total clinic visits and the need for steroid bursts consistent with better asthma control.,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Timmer', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Rosenman', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2019.09.004']
2752,32046669,Development of 'learn to dare!': An online assessment and intervention platform for anxious children.,"BACKGROUND


Many children and adolescents suffer from problematic levels of anxiety, but the multitude of these children do not receive an intervention. It is of importance to increase the accessibility and availability of child anxiety interventions, as to identify and treat anxious children early and successfully. Online platforms that include information, assessments and intervention can contribute to this goal. Interventions for child anxiety are frequently based on Cognitive Behavioral Therapy, because of its strong theoretical and empirical basis. However, the working mechanisms of Cognitive Behavioral Therapy in children are poorly studied. To our knowledge, mediation studies on child anxiety are non-existent regarding online Cognitive Behavioral Therapy.
METHODS


We will aim at children aged 8-13 years with problematic anxiety. We recruit these children via the community setting, and refer them to our online platform 'Learn to Dare!' (in Dutch: 'Leer te Durven!'), https://leertedurven.ou.nl, where information about child anxiety and our research is freely accessible. After an active informed consent procedure, the participants can access the screening procedure, which will select the children with problematic anxiety levels. Thereafter, these children will be randomized to an online intervention based on Cognitive Behavioral Therapy (n = 120) or to a waitlist control (WL, n = 120). The intervention consists of 8 sessions with minimal therapist support and contains psycho-education, exposure (based on inhibitory learning), cognitive restructuring and relapse prevention. Child anxiety symptoms and diagnoses, cognitions, avoidance behavior and level of abstract reasoning are measured. Assessments are the same for both groups and are performed before and after the proposed working mechanisms are offered during the intervention. A follow-up assessment takes place 3 months after the final session, after which children in the waitlist control group are offered to take part in the intervention.
DISCUSSION


This protocol paper describes the development of the online platform 'Learn to Dare!', which includes information about child anxiety, the screening procedure, anxiety assessments, and the online intervention. We describe the development of the online intervention. Offering easy accessible interventions and providing insight into the working mechanisms of Cognitive Behavioral Therapy contributes to optimizing Cognitive Behavioral Therapy for anxious youth.",2020,"A follow-up assessment takes place 3 months after the final session, after which children in the waitlist control group are offered to take part in the intervention.
","['children aged 8-13\u2009years with problematic anxiety', 'anxious youth', 'learn to dare', 'anxious children']","['Cognitive Behavioral Therapy', 'minimal therapist support and contains psycho-education, exposure (based on inhibitory learning), cognitive restructuring and relapse prevention', 'online intervention based on Cognitive Behavioral Therapy']","['Child anxiety symptoms and diagnoses, cognitions, avoidance behavior and level of abstract reasoning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0178494', 'cui_str': 'Avoidance Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}]",,0.0223387,"A follow-up assessment takes place 3 months after the final session, after which children in the waitlist control group are offered to take part in the intervention.
","[{'ForeName': 'Ellin', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands. ellin.simon@ou.nl.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Hullu', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bögels', 'Affiliation': 'Amsterdam University, Nieuwe Achtergracht 127, PO box 15804, 1001, Amsterdam, NH, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Butler', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'van Groeninge', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Slot', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craske', 'Affiliation': 'UCLA, 3229 Franz Hall, Mail Code 156304, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Whiteside', 'Affiliation': 'Mayo Clinic, 201 W Center St, Rochester, MN, 55902, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'van Lankveld', 'Affiliation': 'Open University of the Netherlands, PO box 2960-NL, 6401, DL Heerlen, Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-2462-3']
2753,31300494,Apnoeic oxygenation with nasal cannula oxygen at different flow rates in anaesthetised patients: a study protocol for a non-inferiority randomised controlled trial.,"INTRODUCTION


Apnoeic oxygenation using nasal high-flow oxygen delivery systems with heated and humidified oxygen has recently gained popularity in the anaesthesia community. It has been shown to allow a prolonged apnoea time of up to 65 min as CO 2  increase was far slower compared with previously reported data from CO 2  increase during apnoea. A ventilatory exchange due to the high nasal oxygen flow was proposed explaining that phenomenon. However, recent studies in children did not show any difference in CO 2  clearance comparing high-flow with low-flow oxygen. To investigate this ventilatory exchange in adults, we plan this study comparing different oxygen flow rates and the increase of CO 2  during apnoea. We hypothesise that CO 2  clearance is non-inferior when applying low oxygen flow rates.
METHODS AND ANALYSIS


In this single-centre, single-blinded, randomised controlled trial, we randomly assign 100 patients planned for elective surgery to either control (oxygen 70 L/min, airway opened by laryngoscopy) or one of three intervention groups: oxygen 70, or 10, or 2 L/min, all with jaw thrust to secure airway patency. After anaesthesia induction and neuromuscular blockage, either one of the interventions or the control will be applied according to randomisation. Throughout the apnoea period, we will measure the increase of transcutaneous pCO 2  (tcpCO 2 ) until any one of the following criteria is met: time=15 min, SpO 2  <92%, tcpCO 2  >10.67 kPa, art. pH <7.1, K +  >6.0 mmol/L. Primary outcome is the mean tcpCO 2  increase in kPa/min.
ETHICS AND DISSEMINATION


After Cantonal Ethic Committee of Bern approval (ID 2018-00293, 22.03.2018), all study participants will provide written informed consent. Patients vulnerable towards hypoxia or hypercarbia are excluded. Study results will be published in a peer-reviewed journal and presented at national and international conferences.
TRIAL REGISTRATION NUMBER


This study was registered on www.clinicaltrials.gov (NCT03478774,Pre-results) and the Swiss Trial Registry KOFAM (SNCTP000002861).",2019,"After anaesthesia induction and neuromuscular blockage, either one of the interventions or the control will be applied according to randomisation.","['100 patients planned for elective surgery to either', 'Patients vulnerable towards hypoxia or hypercarbia are excluded', 'anaesthetised patients']","['pH', 'Apnoeic oxygenation with nasal cannula oxygen', 'control (oxygen 70\u2009L/min, airway opened by laryngoscopy']","['mean tcpCO 2  increase in kPa/min', 'apnoea time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",100.0,0.351134,"After anaesthesia induction and neuromuscular blockage, either one of the interventions or the control will be applied according to randomisation.","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Theiler', 'Affiliation': 'Universitaetsklinik fur Anaesthesiologie und Schmerztherapie, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Schneeberg', 'Affiliation': 'Universitaetsklinik fur Anaesthesiologie und Schmerztherapie, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Riedel', 'Affiliation': 'Kantonsspital Graubunden, Chur, Switzerland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Kaiser', 'Affiliation': 'Universitaetsklinik fur Anaesthesiologie und Schmerztherapie, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Riva', 'Affiliation': 'Universitaetsklinik fur Anaesthesiologie und Schmerztherapie, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greif', 'Affiliation': 'Universitaetsklinik fur Anaesthesiologie und Schmerztherapie, Inselspital Bern, Bern, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2018-025442']
2754,30731480,Passive Range-of-Motion Exercise and Bone Mineralization in Preterm Infants: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effect of range-of-motion exercise program on bone mineralization and somatic growth of very low birth weight (VLBW) infants.
STUDY DESIGN


A total of 36 VLBW infants were randomized into 18 VLBW infants receiving range-of-motion exercise and 18 VLBW control infants receiving tactile stimulation for 4 weeks. Laboratory investigations were performed at baseline and postexercise and included serum calcium, serum phosphorus (s.PO 4 ), magnesium, alkaline phosphatase (ALP), urinary calcium/phosphate ratio, and serum carboxy-terminal cross-linked telopeptide of type 1 collagen (CTX). Dual-energy X-ray absorptiometry was performed at the end of the exercise protocol to measure bone mineral content, bone mineral density (BMD), bone area, lean mass, and fat mass.
RESULTS


The weight and the rate of weight gain were significantly higher ( p  < 0.001) in the exercise group compared with controls postexercise. Also, higher s.PO 4 , lower ALP, and lower urinary calcium/phosphate ratio were observed postexercise in the exercise group ( p  = 0.001,  p  = 0.005, and  p  = 0.04, respectively), whereas serum CTX showed no difference between the two groups ( p  = 0.254). Postexercise BMD significantly improved in the exercise group ( p  < 0.001) compared with controls.
CONCLUSION


Although the sample size was small, we may be able to suggest favorable effects of range-of-motion exercise versus tactile stimulation on bone metabolism, BMD, and short-term growth in VLBW infants.",2020,"PO 4 , lower ALP, and lower urinary calcium/phosphate ratio were observed postexercise in the exercise group (","['36 VLBW infants', 'Preterm Infants']","['VLBW infants receiving range-of-motion exercise and 18 VLBW control infants receiving tactile stimulation', 'motion exercise program', 'Dual-energy X-ray absorptiometry', 'Passive Range-of-Motion Exercise and Bone Mineralization']","['lower ALP, and lower urinary calcium/phosphate ratio', 'bone mineralization and somatic growth of very low birth weight (VLBW', 'serum calcium, serum phosphorus (s', 'Postexercise BMD', 'serum CTX', 'bone mineral content, bone mineral density (BMD), bone area, lean mass, and fat mass', 'magnesium, alkaline phosphatase (ALP), urinary calcium/phosphate ratio, and serum carboxy-terminal cross-linked telopeptide of type 1 collagen (CTX', 'weight and the rate of weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",36.0,0.108852,"PO 4 , lower ALP, and lower urinary calcium/phosphate ratio were observed postexercise in the exercise group (","[{'ForeName': 'Rania A', 'Initials': 'RA', 'LastName': 'El-Farrash', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim S', 'Initials': 'IS', 'LastName': 'Abo-Seif', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abeer K', 'Initials': 'AK', 'LastName': 'El-Zohiery', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Gehan M', 'Initials': 'GM', 'LastName': 'Hamed', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Abulfadl', 'Affiliation': 'Neonatal Intensive Care Unit, Maternity Hospital, Ain Shams University, Cairo, Egypt.'}]",American journal of perinatology,['10.1055/s-0039-1678559']
2755,31361019,"Long-term Safety and Tolerability of NKTR-181 in Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain: A Phase 3 Multicenter, Open-Label, 52-Week Study (SUMMIT-08 LTS).","OBJECTIVE


To evaluate the long-term safety of NKTR-181, a novel mu-opioid receptor agonist that may have reduced human abuse potential, in patients with moderate to severe chronic low back pain (CLBP) or other chronic noncancer pain (CNP).
DESIGN


Uncontrolled, multicenter, open-label, long-term study of NKTR-181 comprised of three periods: screening (≤21 days), treatment (52 weeks), and safety follow-up (∼14 days after the last dose of NKTR-181).
SETTING


Multicenter, long-term clinical research study.
METHODS


NKTR-181 administered at doses of 100-600 mg twice daily (BID) was evaluated in opioid-naïve and opioid-experienced patients. Patients were enrolled de novo or following completion of the randomized, placebo-controlled phase 3 efficacy study (SUMMIT-07). Safety assessments included adverse event documentation, measurements of opioid withdrawal, and clinical laboratory tests. Effectiveness was assessed using the modified Brief Pain Inventory Short Form (mBPI-SF).
RESULTS


The study enrolled 638 patients. The most frequently reported treatment-emergent adverse events (TEAEs) were constipation (26%) and nausea (12%). Serious TEAEs, reported in 5% of patients, were deemed by investigators to be unrelated to NKTR-181. There were no deaths or reported cases of respiratory depression. A sustained reduction in mBPI-SF pain intensity and pain interference from baseline to study termination was observed throughout treatment. Only 2% of patients discontinued NKTR-181 due to lack of efficacy, and 11% discontinued due to treatment-related AEs. NKTR-181 doses of up to 600 mg BID were generally well tolerated, and patients experienced low rates of opioid-related adverse events.
CONCLUSIONS


The study results support the premise that NKTR-181 is a safe and effective option for patients with moderate to severe CLBP or CNP.",2020,"Serious TEAEs, reported in 5% of patients, were deemed by investigators to be unrelated to NKTR-181.","['patients with moderate to severe chronic low back pain (CLBP) or other chronic noncancer pain (CNP', 'Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain', 'patients with moderate to severe CLBP or CNP', '638 patients']","['placebo', 'NKTR-181']","['mBPI-SF pain intensity and pain interference', 'adverse event documentation, measurements of opioid withdrawal, and clinical laboratory tests', 'modified Brief Pain Inventory Short Form (mBPI-SF', 'respiratory depression', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4547855', 'cui_str': 'NKTR-181'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",638.0,0.0753513,"Serious TEAEs, reported in 5% of patients, were deemed by investigators to be unrelated to NKTR-181.","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': '*Department of Anesthesiology, Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute and The Center for Clinical Research, Winston-Salem, North Carolina.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Argoff', 'Affiliation': 'Department of Neurology, Albany Medical Center, Albany, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Agaiby', 'Affiliation': 'Clinical Investigation Specialists Inc, Kenosha, Wisconsin.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Doberstein', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Potts', 'Affiliation': 'Great Lakes Research Group, Inc, Bay City, Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Upstate Clinical Research Associates, Williamsville, New York.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Gold Coast Research, LLC, Plantation, Florida.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Markman', 'Affiliation': 'Department of Neurosurgery, Translational Pain Research Program, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz169']
2756,31944250,Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial.,"BACKGROUND


Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse.
OBJECTIVE


The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance.
DESIGN


This was a randomized clinical trial.
SETTING


The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway.
PARTICIPANTS


A total of 153 infants with gestational age <32 weeks at birth were randomly assigned to intervention or control groups.
INTERVENTION


A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day.
MEASUREMENTS


Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA.
RESULTS


No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score < 0 at 3 months CA was about 6 times higher for infants with less than median intervention time than for infants with a longer intervention time.
LIMITATIONS


The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital.
CONCLUSIONS


There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome.",2020,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","['3 university hospitals in Tromsø, Trondheim, and Oslo, Norway', 'A total of 153 infants with gestational age < 32 weeks at birth', 'infants born preterm', 'Neonatal Intensive Care Unit']","['parent-administered exercise program', 'physical therapy', 'Patient-Administered Exercise Program']","['TIMP z-score', 'motor outcome', 'Test of Infant Motor Performance (TIMP', 'motor performance', 'total intervention dose and TIMP z-scores']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",153.0,0.132704,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","[{'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, PB 6050 Langnes, Tromsø, 9037 Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Suzann K', 'Initials': 'SK', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ivar', 'Initials': 'I', 'LastName': 'Heuch', 'Affiliation': 'Department of Mathematics, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjarne K', 'Initials': 'BK', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Centre for Sami Health Research, Department of Community Medicine, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Per Ivar', 'Initials': 'PI', 'LastName': 'Kaaresen', 'Affiliation': 'Pediatric and Adolescent Department, University Hospital North Norway; and Department of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Vibeke Smith', 'Initials': 'VS', 'LastName': 'Aulie', 'Affiliation': 'Section of Physiotherapy, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway.'}]",Physical therapy,['10.1093/ptj/pzaa014']
2757,32039871,The effect of combined scalp acupuncture and cognitive training in patients with stroke on cognitive and motor functions.,"OBJECTIVE


To investigate the effect of combined scalp acupuncture and cognitive training on cognitive and motor functioning in patients with stroke during the recovery stage.
METHODS


Seventy patients with post-stroke cognitive impairment were randomly divided into an experimental group and a control group. Patients in the experimental group additionally received scalp acupuncture and cognitive training, while the control group received sham scalp acupuncture and cognitive training. The cognitive and motor functioning of all patients were assessed using MMSE, LOTCA, and FMA, before and 12 weeks after treatment. In addition, the plasma BDNF and NGF levels were measured from peripheral blood samples using ELISA kits.
RESULTS


After 12 weeks, the MMSE, LOTCA and FMA scores were significantly higher in the experimental group than in the control group. In the experimental group, there was an improvement in the total MMSE score, orientation, spatial executive function, the total LOTCA score, and the score of command of language orientation post-treatment. Significant improvements of BDNF and NGF were found in the experimental group after treatment, while only significant improvements of NGF was found in the control group after treatment. Both BDNF and NGF in the experiment group were higher than those in the control group at the last day of treatment.
CONCLUSIONS


Combined scalp acupuncture and cognitive training can efficiently enhance cognitive and motor functions in patients with stroke during the recovery stage, which may be a more effective rehabilitation treatment after stroke than routine therapy and rehabilitation training alone.",2020,"In the experimental group, there was an improvement in the total MMSE score, orientation, spatial executive function, the total LOTCA score, and the score of command of language orientation post-treatment.","['patients with stroke during the recovery stage', 'patients with stroke on cognitive and motor functions', 'Seventy patients with post-stroke cognitive impairment']","['scalp acupuncture and cognitive training', 'combined scalp acupuncture and cognitive training', 'scalp acupuncture and cognitive training, while the control group received sham scalp acupuncture and cognitive training']","['total MMSE score, orientation, spatial executive function, the total LOTCA score, and the score of command of language orientation post-treatment', 'cognitive and motor functions', 'cognitive and motor functioning', 'BDNF and NGF', 'plasma BDNF and NGF levels', 'NGF', 'MMSE, LOTCA and FMA scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",70.0,0.020397,"In the experimental group, there was an improvement in the total MMSE score, orientation, spatial executive function, the total LOTCA score, and the score of command of language orientation post-treatment.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Zuhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Zhongnan Hospital of Wuhan University, Wuhan, China.'}]",NeuroRehabilitation,['10.3233/NRE-192942']
2758,31294768,Efficacy of Phacoemulsification Alone vs Phacoemulsification With Goniosynechialysis in Patients With Primary Angle-Closure Disease: A Randomized Clinical Trial.,"Importance


The effectiveness of intraocular pressure (IOP) lowering phacoemulsification combined with goniosynechialysis (GSL) compared with phacoemulsification without GSL remains unknown.
Objective


To compare the IOP outcome after 1 year in patients with synechial primary angle-closure disease (PACD) and cataract who underwent phacoemulsification with intraocular lens implantation (PEI) alone compared with PEI with GSL (PEI-GSL).
Design, Setting, and Participants


A multicenter randomized clinical trial was conducted from September 29, 2011, to March 16, 2015; data analysis was performed from April 1, 2015, to March 4, 2019. Patients with PACD, defined as primary angle closure or primary angle-closure glaucoma, and at least 90° peripheral anterior synechiae (PAS) with cataract were included. Patients were randomized to undergo PEI alone or PEI-GSL. Patients were followed up for 1 year with standardized evaluations. Intention-to-treat analysis was performed.
Interventions


Phacoemulsification with intraocular lens implantation alone or with GSL.
Main Outcomes and Measures


Successful control of IOP at 12 months, defined as IOP 21 mm Hg or lower without use of topical IOP-lowering medications and a decrease in IOP of 20% or more from baseline IOP.
Results


Data from 78 patients (78 eyes) were analyzed. Of these, 37 patients were Chinese (47.4%) and 54 were women (69.2%); mean (SD) age was 67.7 (8.9) years. Mean deviation (SD) at baseline was -13.5 dB (9.4 dB). Forty patients were randomized to the PEI group and 38 to the PEI-GSL group. The mean (SD) IOP at baseline was 22.3 (8.5) mm Hg for the PEI group and 22.9 (5.3) mm Hg for the PEI-GSL group. At 1 year, the mean IOP was 14.3 (5.0) mm Hg for the PEI group and 15.9 (4.5) mm Hg for the PEI-GSL group. Successful control at 1 year occurred in 21 patients (52.5%) in the PEI group and 22 patients (57.9%) in the PEI-GSL group (mean difference, 5.4%; 95% CI, -18.0% to 28.2%; P = .63). In eyes that achieved successful control, mean IOP at 1 year was 12.5 (2.7) mm Hg (range, 7.0-19.0) for the PEI group and 13.6 (2.4) mm Hg (range, 9.0-18.0) for the PEI-GSL group. The number of medications at baseline and 1 year decreased from a mean of 2.2 (0.8) to 0.5 (0.9) in the PEI group and 1.9 (0.9) to 0.6 (1.2) in the PEI-GSL group (P < .001 for each), with a mean change difference of 0.4% (95% CI, -0.02% to 0.9%; P = .06). There were 3 postoperative complications (7.5%) in the PEI group and 3 (7.9%) in the PEI-GSL group. These included IOP spike (IOP≥30 mm Hg) (n = 3), excessive anterior chamber inflammation (n = 1), and posterior capsule opacification (n = 2).
Conclusions and Relevance


This randomized clinical trial was unable to show that PEI-GSL added additional IOP lowering compared with PEI alone in patients with PACD.
Trial Registration


ClinicalTrials.gov identifier: NCT02376725.",2019,"In eyes that achieved successful control, mean IOP at 1 year was 12.5 (2.7) mm Hg (range, 7.0-19.0) for the PEI group and 13.6 (2.4) mm Hg (range, 9.0-18.0) for the PEI-GSL group.","['Forty patients', 'September 29, 2011, to March 16, 2015; data analysis was performed from April 1, 2015, to March 4, 2019', 'Patients With Primary Angle-Closure Disease', '78 patients (78 eyes) were analyzed', 'patients with synechial primary angle-closure disease (PACD) and cataract who underwent', 'patients with PACD', 'Patients with PACD, defined as primary angle closure or primary angle-closure glaucoma, and at least 90° peripheral anterior synechiae (PAS) with cataract were included', '37 patients were Chinese (47.4%) and 54 were women (69.2%); mean (SD) age was 67.7 (8.9) years']","['Alone vs Phacoemulsification', 'Phacoemulsification', 'PEI-GSL', 'Goniosynechialysis', 'phacoemulsification with intraocular lens implantation (PEI) alone compared with PEI with GSL (PEI-GSL', 'intraocular pressure (IOP) lowering phacoemulsification combined with goniosynechialysis (GSL', 'PEI alone or PEI-GSL', 'Interventions\n\n\nPhacoemulsification with intraocular lens implantation alone or with GSL', 'PEI']","['IOP', 'mean IOP', 'IOP spike', 'number of medications', 'mean (SD) IOP', 'IOP outcome', 'Mean deviation (SD', 'successful control, mean IOP', 'excessive anterior chamber inflammation', 'postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0632834', 'cui_str': 'PACD'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0017606', 'cui_str': 'Primary angle-closure glaucoma (disorder)'}, {'cui': 'C0154934', 'cui_str': 'Goniosynechiae'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1276060', 'cui_str': 'Phacoemulsification of lens and insertion of prosthetic replacement (procedure)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",40.0,0.200737,"In eyes that achieved successful control, mean IOP at 1 year was 12.5 (2.7) mm Hg (range, 7.0-19.0) for the PEI group and 13.6 (2.4) mm Hg (range, 9.0-18.0) for the PEI-GSL group.","[{'ForeName': 'Rahat', 'Initials': 'R', 'LastName': 'Husain', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Do', 'Affiliation': 'Vietnam National Institute of Ophthalmology, Hanoi, Vietnam.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Li Ka Shing Faculty of Medicine, University of Hong Kong and Queen Mary's Hospital, Hong Kong.""}, {'ForeName': 'Naris', 'Initials': 'N', 'LastName': 'Kitnarong', 'Affiliation': 'Faculty of Medicine, Siriraj Hospital, Mahjidol University, Bangkok, Thailand.'}, {'ForeName': 'Monisha E', 'Initials': 'ME', 'LastName': 'Nongpiur', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Shamira A', 'Initials': 'SA', 'LastName': 'Perera', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Ching L', 'Initials': 'CL', 'LastName': 'Ho', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore.'}, {'ForeName': 'Sheng K', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': ""Department of Ophthalmology, Guy's and St Thomas' National Health Services Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Aung', 'Affiliation': 'Singapore National Eye Centre, Singapore Eye Research Institute, Singapore.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.2493']
2759,31729052,"Split-Sided Chest Study of Skin Rejuvenation Comparing Low-Energy, 1,927-nm Thulium Fractional Laser Treatment Prior to Photodynamic Therapy Versus Photodynamic Therapy Alone.","BACKGROUND AND OBJECTIVES


Treatment of photoaging and intrinsic aging of the chest, with the associated concerns of skin roughness, uneven pigmentation, laxity, atrophy, and telangiectasias, can be problematic because of the potential for worsened esthetic outcomes with existing treatments. This study assessed the efficacy and safety of using nonablative fractional laser therapy (FLT) pretreatment with photodynamic therapy (PDT) versus PDT alone for chest rejuvenation.
STUDY DESIGN/MATERIALS AND METHODS


In a randomized, evaluator-blinded, split-sided study, adult female patients with photodamage to the chest received three treatment courses over an 8-week period with follow-up visits at Weeks 12 and 20. FLT was applied to one side of the chest, randomly assigned at baseline, followed by aminolevulinic acid-based PDT, delivered using a thermal, short incubation, broad area technique, to both sides of the chest. In-person and photographic assessments were conducted using five-point scales to evaluate outcomes including rhytides, pigmentation, skin texture, and telangiectasias.
RESULTS


Eleven adults completed the study, of whom 11 had improved scores for rhytides and 10 had improved scores for skin texture at Week 20. There was no significant difference in any efficacy outcome between FLT and PDT and standard PDT alone. The severity of adverse events was rated significantly greater with the combined FLT-PDT treatment vs PDT alone.
CONCLUSIONS


Significant improvements were observed vs baseline for both sides of the chest treated with FLT-PDT or standard PDT following three treatment sessions. No significant difference in efficacy was observed between treatment approaches, although adverse events were more severe on the FLT-pretreated side. This study was not registered as it qualified as a nonsignificant risk study. Lasers Surg. Med. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.",2020,"No significant difference in efficacy was observed between treatment approaches, although adverse events were more severe on the FLT-pretreated side.","['adult female patients with photodamage to the chest', '2019']","['photodynamic therapy (PDT) versus PDT alone', 'Photodynamic Therapy Versus Photodynamic Therapy Alone', 'nonablative fractional laser therapy (FLT', 'FLT-PDT or standard PDT', 'FLT', 'Skin Rejuvenation', 'Low-Energy, 1,927-nm Thulium Fractional Laser Treatment']","['adverse events', 'efficacy and safety', 'rhytides, pigmentation, skin texture, and telangiectasias', 'efficacy', 'efficacy outcome', 'scores for skin texture', 'severity of adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}]","[{'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C1432709', 'cui_str': ""(18F)3'-deoxy-3'-fluorothymidine""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2729169', 'cui_str': 'Wrinkled structure (morphologic abnormality)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0423752', 'cui_str': 'Skin texture (observable entity)'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",11.0,0.0276623,"No significant difference in efficacy was observed between treatment approaches, although adverse events were more severe on the FLT-pretreated side.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Croix', 'Affiliation': 'Union Square Laser Dermatology, 19 Union Square West, New York, New York, 10003.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Burge', 'Affiliation': 'Union Square Laser Dermatology, 19 Union Square West, New York, New York, 10003.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chwalek', 'Affiliation': 'Union Square Laser Dermatology, 19 Union Square West, New York, New York, 10003.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Gmyrek', 'Affiliation': 'Union Square Laser Dermatology, 19 Union Square West, New York, New York, 10003.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chapas', 'Affiliation': 'Union Square Laser Dermatology, 19 Union Square West, New York, New York, 10003.'}]",Lasers in surgery and medicine,['10.1002/lsm.23178']
2760,32039955,No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,"BACKGROUND


In kinematic alignment in TKA, the aim is to match the implant's position to the pre-arthritic anatomy of an individual patient, in contrast to the traditional goal of neutral mechanical alignment. However, there are limited mid-term, comparative data for survivorship and functional outcomes for these two techniques.
QUESTIONS/PURPOSES


In the setting of a randomized, controlled trial at 5 years, is there a difference between kinematic alignment and mechanical alignment in TKA in terms of (1) patient-reported outcome measures, (2) survivorship free from revision or reoperation, and (3) the incidence of radiographic aseptic loosening?
METHODS


In the initial study, 99 primary TKAs for osteoarthritis were randomized to either the mechanical alignment (n = 50) or kinematic alignment (n = 49) group. Computer navigation was used in the mechanical alignment group, and patient-specific cutting blocks were used in the kinematic alignment group. At 5 years, 95% (48 of 50) of mechanical alignment and 96% (47 of 49) of kinematic alignment TKAs were available for follow-up. Knee function was assessed using the Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component) was determined via Kaplan-Meier analysis. Radiographs were assessed for signs of aseptic loosening (as defined by the presence of progressive radiolucent lines in two or more zones) by a single blinded observer.
RESULTS


At 5 years, there were no differences in any patient-reported outcome measure between the two groups. For example, the mean OKS did not differ between the two groups (kinematic alignment: 41.4 ± 7.2 versus mechanical alignment: 41.7 ± 6.3; difference -0.3 [95% confidence interval - 3.2 to 2.5]; p = 0.99). At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681). At 5 years, one patient demonstrated radiographic aseptic loosening for the mechanical alignment group; no cases were identified for the kinematic alignment group.
CONCLUSIONS


We found no mid-term functional or radiographic differences between TKAs with mechanical alignment or kinematic alignment. The anticipated improvements in patient-reported outcomes with kinematic alignment were not realized. Because kinematic alignment results in a high proportion of patients whose tibial components are inserted in varus, loosening remains a potential long-term concern. Given the unknown impact on long-term survivorship of the substantial alignment alterations with kinematic alignment, our findings do not support the routine use of kinematic alignment outside of a research setting.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","['99 primary TKAs for osteoarthritis', 'TKA']",['mechanical alignment (n = 50) or kinematic alignment'],"['Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component', 'survivorship free from revision', '5-year Clinical or Radiographic Outcomes', 'survivorship free from reoperation', 'mean OKS', 'Knee function', 'radiographic aseptic loosening', 'signs of aseptic loosening']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0038955'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",99.0,0.152917,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","[{'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Young', 'Affiliation': 'S. W. Young, Department of Surgery, University of Auckland, Auckland, New Zealand S. W. Young, M. L. Walker, S. Holland, A. Bayan, B. Farrington, Department of Orthopaedic Surgery, North Shore Hospital, Auckland New Zealand N. P. T. Sullivan, Orthopaedic Department, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Niall P T', 'Initials': 'NPT', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bayan', 'Affiliation': ''}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Farrington', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001150']
2761,31536162,Increased Tattoo Fading in a Single Laser Tattoo Removal Session Enabled by a Rapid Acoustic Pulse Device: A Prospective Clinical Trial.,"BACKGROUND AND OBJECTIVES


The ability to provide improved tattoo fading using multiple laser passes in a single office laser tattoo removal session is limited. In part, this is due to the loss of laser effectiveness caused by epidermal and dermal vacuole ""whitening"" generated during the initial laser pass at the tattoo site. The Rapid Acoustic Pulse (RAP) device generates acoustic shock wave pulses that clear epidermal and dermal vacuoles to enable multiple laser passes in a single office laser tattoo removal session. The objectives of this study were to determine if the RAP device, when used as an accessory to the 1064 nm Nd:YAG Q-switched (QS) laser can enable delivery of multiple laser passes in a single office laser tattoo removal session, and therefore result in increased tattoo fading compared to the clinical standard single-pass QS laser tattoo removal session.
STUDY DESIGN/MATERIALS AND METHODS


The RAP device was evaluated in a single-center (SkinCare Physicians), prospective, IRB approved study. A total of 32 black ink tattoos, from 21 participants, were divided into three zones and treated with either multiple QS laser passes, each followed by 1 minute of RAP device application (Laser + RAP) in zone one and single-pass QS laser treatment (Laser-Only) in zone two, separated by an untreated control zone. The treatment sites were assessed for the number of laser passes and adverse events immediately, 6 weeks, and 12 weeks following the treatment session. Photographs of the treatment sites were assessed for percent fading at 12 weeks post-treatment by three blinded reviewers.
RESULTS


When the RAP device was applied as an accessory to the QS laser in a multi-pass laser tattoo removal treatment, an average of 4.2 laser passes were delivered in a single session, with no unexpected or serious RAP device-related adverse events. At the 12-week follow-up, tattoos treated with Laser + RAP showed a statistically significant increase in average fading (44.2%) compared with tattoos treated with Laser-Only (24.8%) (P < 0.01). Additionally, a significantly higher overall proportion of tattoos treated with Laser + RAP (37.5%) had a response of >50% fading compared with tattoos treated with QS Laser-Only (9.4%) (P < 0.01) as well as a response of >75% fading from Laser + RAP treatment (21.9%) compared with Laser-Only treatment (3.1%) (P < 0.05).
CONCLUSIONS


The RAP device, applied as an accessory to the 1064 nm Nd:YAG QS laser, safely enables multiple QS laser treatments in a single office laser tattoo removal session by clearing the whitening caused by the previous QS laser pass. Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.",2020,Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session.,"['A total of 32 black ink tattoos, from 21 participants', '2019']","['YAG Q-switched (QS) laser', 'multiple QS laser passes, each followed by 1 minute of RAP device application (Laser\u2009+\u2009RAP) in zone one and\xa0single-pass QS laser treatment (Laser-Only) in zone two, separated by an untreated control zone']","['tattoo fading', 'Increased Tattoo Fading', 'average fading']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0021510', 'cui_str': 'Ink'}]","[{'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1289832', 'cui_str': 'QS laser'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0445262', 'cui_str': 'Single pass (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1366940', 'cui_str': 'Tattoo of skin (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0169592,Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session.,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kaminer', 'Affiliation': 'SkinCare Physicians, Chestnut Hill, Massachusetts, 02467.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Capelli', 'Affiliation': 'Soliton, Inc., Houston, Texas, 77081.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sadeghpour', 'Affiliation': 'SkinCare Physicians, Chestnut Hill, Massachusetts, 02467.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Ibrahim', 'Affiliation': 'SkinCare Physicians, Chestnut Hill, Massachusetts, 02467.'}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Honda', 'Affiliation': 'Soliton, Inc., Houston, Texas, 77081.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Robertson', 'Affiliation': 'Soliton, Inc., Houston, Texas, 77081.'}]",Lasers in surgery and medicine,['10.1002/lsm.23163']
2762,32051002,Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial.,"BACKGROUND


Sexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors' sexual concerns and enhance their and their partners' sexual, relationship, and psychological outcomes.
METHODS


This trial is designed to evaluate the efficacy of the IE intervention in improving survivors' sexual function, the primary study outcome. Secondary outcomes include survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms). Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function. Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners are recruited from two academic sites in the USA and are randomized to either the IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together). The target sample size is 120 couples. Self-report outcome measures are administered to participants in both conditions at baseline (T1), post-treatment (T2), 3 months post-treatment (T3), and 6 months post-treatment (T4).
DISCUSSION


Evidence-based interventions are needed to address sexual concerns for breast cancer survivors and to enhance their and their intimate partners' sexual, relationship, and psychological well-being. This randomized controlled trial will allow us to examine the efficacy of a novel couple-based intervention delivered via telephone for breast cancer survivors experiencing sexual concerns and their intimate partners, in comparison with an attention control. Findings of this study could influence clinical care for women with breast cancer and inform theory guiding cancer-related sexual rehabilitation.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03930797. Registered on 24 April 2019.",2020,Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function.,"['120 couples', 'breast cancer survivors experiencing sexual concerns and their intimate partners', 'breast cancer survivors', 'women with breast cancer', 'Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners']","['four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE', 'social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy', 'novel couple-based intervention delivered via telephone', 'couple-based intervention addressing sexual concerns', 'IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together', 'IE intervention']","[""survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms""]","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302822', 'cui_str': 'Couples Therapy'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0479534,Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function.,"[{'ForeName': 'Jennifer Barsky', 'Initials': 'JB', 'LastName': 'Reese', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA. Jennifer.Reese@fccc.edu.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Zimmaro', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Sorice', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Handorf', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Clinical Genetics, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Schover', 'Affiliation': 'Will2Love LLC, 1333 Old Spanish Trail, Suite G, #134, Houston, TX, 77054, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kashy', 'Affiliation': 'Department of Psychology, Michigan State University, 316 Physics Road, Room 262, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Department of Medicine-Oncology, Duke University Medical Center, DUMC 3459, Durham, NC, 27710, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University Medical Center, DUMC 90399, Durham, NC, 27708, USA.'}]",Trials,['10.1186/s13063-019-3975-2']
2763,31290948,Efficacy of Short-term Treatment of Internet and Computer Game Addiction: A Randomized Clinical Trial.,"Importance


Internet and computer game addiction represent a growing mental health concern, acknowledged by the World Health Organization.
Objective


To determine whether manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA), is efficient in individuals experiencing internet and computer game addiction.
Design, Setting, and Participants


A multicenter randomized clinical trial was conducted in 4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups. Blinded measurements were conducted. A consecutive sample of 143 men was randomized to the treatment group (STICA; n = 72) or wait-list control (WLC) group (n = 71). Main inclusion criteria were male sex and internet addiction as the primary diagnosis. The STICA group had an additional 6-month follow-up (n = 36). Data were analyzed from November 2018 to March 2019.
Interventions


The manualized CBT program aimed to recover functional internet use. The program consisted of 15 weekly group and up to 8 two-week individual sessions.
Main Outcomes and Measures


The predefined primary outcome was the Assessment of Internet and Computer Game Addiction Self-report (AICA-S). Secondary outcomes were self-reported internet addiction symptoms, time spent online on weekdays, psychosocial functioning, and depression.
Results


A total of 143 men (mean [SD] age, 26.2 [7.8] years) were analyzed based on intent-to-treat analyses. Of these participants, 50 of 72 men (69.4%) in the STICA group showed remission vs 17 of 71 men (23.9%) in the WLC group. In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age. Compared with the WLC groups, effect sizes at treatment termination of STICA were d = 1.19 for AICA-S, d = 0.88 for time spent online on weekdays, d = 0.64 for psychosocial functioning, and d = 0.67 for depression. Fourteen adverse events and 8 serious adverse events occurred. A causal relationship with treatment was considered likely in 2 AEs, one in each group.
Conclusions and Relevance


Short-term treatment for internet and computer game addiction is a promising, manualized, short-term CBT for a broad range of internet addictions in multiple treatment centers. Further trials investigating the long-term efficacy of STICA and addressing specific groups and subgroups compared with active control conditions are required.
Trial Registration


ClinicalTrials.gov identifier: NCT01434589.",2019,"In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age.","['individuals experiencing internet and computer game addiction', 'A consecutive sample of 143 men', 'A total of\u2009143 men (mean [SD] age, 26.2 [7.8] years) were analyzed based on intent-to-treat analyses', 'Game Addiction', '4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups']","['WLC', 'Internet and Computer', 'wait-list control (WLC', 'STICA', 'manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA']","['Assessment of Internet and Computer Game Addiction Self-report (AICA-S', 'self-reported internet addiction symptoms, time spent online on weekdays, psychosocial functioning, and depression']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0840233,"In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wölfling', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Müller', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dreier', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'Interdisciplinary Center for Clinical Trials Mainz, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Deuster', 'Affiliation': 'Interdisciplinary Center for Clinical Trials Mainz, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'University Hospital of Tübingen, Department of Psychiatry and Psychotherapy, Section for Addiction Research and Medicine, Tübingen, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Medical Faculty Mannheim, Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Musalek', 'Affiliation': 'Department of Psychiatry, Anton Proksch Institute, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schuster', 'Affiliation': 'Department of Psychiatry, Anton Proksch Institute, Vienna, Austria.'}, {'ForeName': 'Tagrid', 'Initials': 'T', 'LastName': 'Lemenager', 'Affiliation': 'Medical Faculty Mannheim, Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hanke', 'Affiliation': 'University Hospital of Tübingen, Department of Psychiatry and Psychotherapy, Section for Addiction Research and Medicine, Tübingen, Germany.'}, {'ForeName': 'Manfred E', 'Initials': 'ME', 'LastName': 'Beutel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1676']
2764,32049065,Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial.,"BACKGROUND


Technology-in particular, access to the Internet from a mobile device-has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs.
OBJECTIVE


A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA).
METHODS


A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months.
RESULTS


Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; P>.05).
CONCLUSIONS


Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583.",2020,"RESULTS


Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018).","['adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA', '117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months', 'Overweight or Obese Women']",['Mobile App'],"['maintain muscle mass', 'body fat loss', 'weight loss', 'light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}]",117.0,0.0761876,"RESULTS


Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernández-Reyes', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cámara-Martos', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Molina Recio', 'Affiliation': 'Department of Nursing, School of Medicine and Nursing, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Department of Nursing, School of Medicine and Nursing, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Saldaña', 'Affiliation': 'Department of Occupational Safety and Health, Córdoba City Hall, Córdoba, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Moreno Rojas', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Córdoba, Spain.'}]",JMIR mHealth and uHealth,['10.2196/13747']
2765,31937503,The therapeutic effect of treatment with RehaCom software on verbal performance in patients with multiple sclerosis.,"Multiple sclerosis (MS) is characterized by central nervous system lesions that lead to neurological dysfunctions including fatigue, depression and anxiety. MS is affecting almost 2.3 million people around the world, with the significant highest prevalence in the North America. MS also affects different cognitive abilities, such as attention, memory and executive functions. Furthermore, a significant impairment in verbal fluency and naming abilities in patients with MS has been reported. RehaCom, is a software that has improvement effects on cognitive functions. The goal of this research is to investigate the effect of treatment with RehaCom on verbal performance in patients with MS. To select the participants, 60 patients with MS who referred to our clinic were chosen randomly and divided into Control (n = 30) and Experimental (n = 30) groups. The participants in the experimental group were treated by RehaCom software for 10 sessions during 5 weeks (2 sessions per week and each session was 1 h). Controlled Oral Word Association Test (COWAT) and California Verbal Learning Test - Second Edition (CVLT-II), were used to assess verbal performance (verbal fluency, and verbal learning and memory) at weeks 0 (baseline), 5 (post-test) and 10 (follow-up). The results showed that, treatment with RehaCom improved verbal performance in patient with MS, at both post-test and follow-up stages. In conclusion, treatment with RehaCom cognitive rehabilitation software can improve verbal fluency, and verbal learning and memory in patient with MS, possibly by affecting the brain regions involved in language performance.",2020,"The results showed that, treatment with RehaCom improved verbal performance in patient with MS, at both post-test and follow-up stages.","['patients with multiple sclerosis', '60 patients with MS who referred to our clinic', 'patients with MS']","['Controlled Oral Word Association Test (COWAT) and California Verbal Learning Test - Second Edition (CVLT-II', 'RehaCom', 'RehaCom cognitive rehabilitation software', 'RehaCom software']","['verbal fluency, and verbal learning and memory', 'verbal performance', 'verbal fluency and naming abilities', 'verbal performance (verbal fluency, and verbal learning and memory', 'cognitive abilities, such as attention, memory and executive functions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",60.0,0.0146721,"The results showed that, treatment with RehaCom improved verbal performance in patient with MS, at both post-test and follow-up stages.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Arian Darestani', 'Affiliation': 'Department of Psychology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Naeeni Davarani', 'Affiliation': 'Department of Psychology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hassani-Abharian', 'Affiliation': 'Department of Rehabilitation, Brain and Cognition Clinic, Institute for Cognitive Science Studies (ICSS), Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Zarrindast', 'Affiliation': 'Institute for Cognitive Science Studies (ICSS), Tehran, Iran; Department of Pharmacology School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasehi', 'Affiliation': 'Cognitive and Neuroscience Research Center (CNRC), Amir-Almomenin Hospital, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran. Electronic address: Nasehi@iricss.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.01.007']
2766,32048170,"Efficacy of Modified Qufeng Runmian Powder () on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","OBJECTIVE


To evaluate the efficacy and safety of a Chinese medicine (CM) Modified Qufeng Runmian Powder (, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis.
METHODS


In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score (ASS). The secondary indices of efficacy included the changes in the dermatology life quality index (DLQI) score, VISIA scores (spots, pores, brown spots, porphyrins and red areas) and skin assessment (skin pH, sebum amount and hydration) according to a SOFT skin multianalyzer.
RESULTS


(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group. (2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5% (86/103) vs. 31.7% (32/101), P<0.01)] with 95% confidence interval of 39.3%-66.4%. (3) DLQI: DLQI scores were significantly decreased the treatment and control groups (both P<0.01), but the treatment group was more obvious than the placebo group (P<0.01). (4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline (P<0.05). In the control group, the scores of brown spots and pores decreased compared with baseline (P<0.05). The improvement was more obvious in the treatment group than in the control group for all items (P<0.05). (5) Skin assessment: the pH and sebum score in the both groups decreased drastically compared with the baseline (all P<0.01), however, the improvement was more obvious in the treatment group than in the control group (P<0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline (both P>0.05). (6) Safety: two cases of mild drug allergy were observed in the treatment group.
CONCLUSION


MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis. (No. ChiCTR1900020479).",2020,MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.,"['acne vulgaris with CM syndromes of dampness and blood stasis', '220 acne vulgaris patients with CM syndrome of dampness and blood stasis', '204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group', 'Acne Vulgaris with Syndromes of Dampness and Blood Stasis']","['Placebo', 'Modified Qufeng Runmian Powder ', 'DLQI', 'placebo', 'MQFRMP or the placebo', 'Chinese medicine (CM) Modified Qufeng Runmian Powder (, MQFRMP', 'MQFRMP']","['dermatology life quality index (DLQI) score, VISIA scores (spots, pores, brown spots, porphyrins and red areas) and skin assessment (skin pH, sebum amount and hydration) according to a SOFT skin multianalyzer', 'efficacy and safety', 'mild drug allergy', 'VISIA scores: the scores of spots, brown spots and red areas', 'acne severity score (ASS', 'hydration amount', 'DLQI scores', 'pH and sebum score', 'scores of brown spots and pores', '2) Effective rate', 'total effective rate']","[{'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0005768'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C4706308', 'cui_str': 'Dermatology Life Quality Index score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0032712', 'cui_str': 'Porphyrins'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0232445', 'cui_str': 'Skin pH (observable entity)'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3662272', 'cui_str': 'Drug allergy'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0324145', 'cui_str': 'Donkeys'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",220.0,0.140507,MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.,"[{'ForeName': 'Tian-Bo', 'Initials': 'TB', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Bai', 'Affiliation': 'Department of Dermatology and Venereology, China-Japan Friendship Hospital, Beijing, 100029, China. zhi@tsinghua.edu.cn.'}, {'ForeName': 'Hao-Yu', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Chinese Medicine Hospital Affiliated with Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Jiu-Li', 'Initials': 'JL', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Beijing Shunyi Hospital of Traditional Chinese Medicine, Beijing, 101300, China.'}, {'ForeName': 'Ri-Qu', 'Initials': 'RQ', 'LastName': 'Cao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Zi-Hua', 'Initials': 'ZH', 'LastName': 'Wu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Yu-Chao', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3214-4']
2767,31994751,"Comparison of posterior-stabilized, cruciate-retaining, and medial-stabilized knee implant motion during gait.","Accurate knowledge of knee joint motion is needed to evaluate the effects of implant design on functional performance and component wear. We conducted a randomized controlled trial to measure and compare 6-degree-of-freedom (6-DOF) kinematics and femoral condylar motion of posterior-stabilized (PS), cruciate-retaining (CR), and medial-stabilized (MS) knee implant designs for one cycle of walking. A mobile biplane X-ray imaging system was used to accurately measure 6-DOF tibiofemoral motion as patients implanted with PS (n = 23), CR (n = 25), or MS (n = 26) knees walked over ground at their self-selected speeds. Knee flexion angle did not differ significantly between the three designs. Relative movements of the femoral and tibial components were generally similar for PS and CR with significant differences observed only for anterior tibial drawer. Knee kinematic profiles measured for MS were appreciably different: external rotation and abduction of the tibia were increased while peak-to-peak anterior drawer was significantly reduced for MS compared with PS and CR. Anterior-posterior drawer and medial-lateral shift of the tibia were strongly coupled to internal-external rotation for MS, as was anterior-posterior translation of the contact center in the lateral compartment. MS exhibited the least amount of paradoxical anterior translation of the femur relative to the tibia during knee flexion. The joint center of rotation in the transverse plane was located in the lateral compartment for PS and CR and in the medial compartment for MS. Substantial differences were evident in 6-DOF knee kinematics between the healthy knee and all three prosthetic designs. Overall, knee kinematic profiles observed for MS resemble those of the healthy joint more closely than PS and CR.",2020,"Knee flexion angle (maximum, minimum, and peak-to-peak range) did not differ significantly between the three designs.","['one cycle of walking', 'patients implanted with PS (n = 23), CR (n = 25) or MS (n = 26) knees walked over ground at their self-selected speeds']","['6-degree-of-freedom (6-DOF) kinematics and femoral condylar motion of posterior-stabilized (PS), cruciate-retaining (CR) and medial-stabilized (MS) knee implant designs', 'Posterior-stabilized, Cruciate-retaining, and Medial-stabilized Knee Implant Motion during Gait']","['6-DOF tibiofemoral motion', 'Knee kinematic profiles', 'peak-to-peak anterior drawer', 'Knee flexion angle (maximum, minimum, and peak-to-peak range', 'external rotation and abduction of the tibia', '6-DOF knee kinematics', 'Relative movements of the femoral and tibial components']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0453897', 'cui_str': 'Drawers (physical object)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",26.0,0.028844,"Knee flexion angle (maximum, minimum, and peak-to-peak range) did not differ significantly between the three designs.","[{'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Gray', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Shanyuanye', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Young', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Dowsey', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Choong', 'Affiliation': ""Department of Surgery, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Pandy', 'Affiliation': 'Department of Mechanical Engineering, University of Melbourne, Parkville, Victoria, Australia.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24613']
2768,30289355,"Infection risk with alemtuzumab decreases over time: pooled analysis of 6-year data from the CAMMS223, CARE-MS I, and CARE-MS II studies and the CAMMS03409 extension study.","BACKGROUND


Reduced MS disease activity with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) in core phase 2/3 studies was accompanied by increased incidence of infections that were mainly nonserious and responsive to treatment. Alemtuzumab efficacy was durable over 6 years.
OBJECTIVE


To evaluate infections over 6 years in alemtuzumab-treated patients.
METHODS


Three randomized trials (CAMMS223, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) I, and CARE-MS II) compared two courses of alemtuzumab 12 mg with SC IFNB-1a 44 μg in patients with active relapsing-remitting MS. An extension study (CAMMS03409) provided further evaluation and as-needed alemtuzumab retreatment.
RESULTS


Infections occurred more frequently with alemtuzumab 12 mg than SC IFNB-1a during Years 1 (58.7% vs 41.3%) and 2 (52.6% vs 37.7%), but declined for alemtuzumab-treated patients in Years 3 (46.6%), 4 (42.8%), 5 (40.9%), and 6 (38.1%). Serious infections were uncommon (1.0%-1.9% per year). Infections were predominantly (>95%) mild to moderate and included upper respiratory tract infections, urinary tract infections, and mucocutaneous herpetic infections. Prophylactic acyclovir reduced herpetic infections. Lymphocyte counts after alemtuzumab therapy did not predict infection risk.
CONCLUSION


Infections with alemtuzumab were mostly mild to moderate and decreased over time, consistent with preservation of components of protective immunity.",2019,Serious infections were uncommon (1.0%-1.9% per year).,"['patients with active relapsing-remitting MS', '6\u2009years in alemtuzumab-treated patients']","['Alemtuzumab', 'Prophylactic acyclovir', 'alemtuzumab 12\u2009mg with SC IFNB-1a', 'alemtuzumab', 'alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a', 'alemtuzumab therapy']","['upper respiratory tract infections, urinary tract infections, and mucocutaneous herpetic infections', 'herpetic infections', 'Lymphocyte counts', 'Alemtuzumab efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]",,0.0653107,Serious infections were uncommon (1.0%-1.9% per year).,"[{'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Wray', 'Affiliation': 'Hope Neurology MS Center, Knoxville, TN, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Havrdova', 'Affiliation': 'MS Center, Department of Neurology, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Snydman', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montréal Neurological Institute, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Alasdair J', 'Initials': 'AJ', 'LastName': 'Coles', 'Affiliation': 'University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Krzysztof W', 'Initials': 'KW', 'LastName': 'Selmaj', 'Affiliation': 'Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Weiner', 'Affiliation': ""The Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Margolin', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Madalina C', 'Initials': 'MC', 'LastName': 'Chirieac', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'D Alastair S', 'Initials': 'DAS', 'LastName': 'Compston', 'Affiliation': 'University of Cambridge School of Clinical Medicine, Cambridge, UK.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518796675']
2769,32053119,The Implementation of a Text Messaging Intervention to Improve HIV Continuum of Care Outcomes Among Persons Recently Released From Correctional Facilities: Randomized Controlled Trial.,"BACKGROUND


Previously incarcerated individuals have suboptimal linkage and engagement in community HIV care. Mobile health (mHealth) interventions have been shown to be effective in addressing these gaps. In Washington, District of Columbia (DC), we conducted a randomized trial of an SMS text messaging-based mHealth intervention (CARE+ Corrections) to increase linkage to community HIV care and antiretroviral treatment adherence among HIV-infected persons involved in the criminal justice system.
OBJECTIVE


This study aimed to describe the SMS text messaging-based intervention, participant use of the intervention, and barriers and facilitators of implementation.
METHODS


From August 2013 to April 2015, HIV-positive incarcerated individuals were recruited within the DC Department of Corrections, and persons released in the past 6 months were recruited within the community via street-based recruitment, community partnerships, and referrals. Participants were followed for 6 months and received weekly or daily SMS text messages. Formative research resulted in the development of the content of the messages in 4 categories: HIV Appointment Reminders, Medication Adherence, Prevention Reminders, and Barriers to Care following release from jail. Participants could customize the timing, frequency, and message content throughout the study period.
RESULTS


Of the 112 participants enrolled, 57 (50.9%) were randomized to the intervention group and 55 (49.1%) to the control group; 2 control participants did not complete the baseline visit, and were dropped from the study, leaving a total of 110 participants who contributed to the analyses. Study retention was similar across both study arms. Median age was 42 years (IQR 30-50), 86% (49/57) were black or African American, 58% (33/57) were male, 25% (14/57) were female, and 18% (10/57) were transgender. Median length of last incarceration was 4 months (IQR 1.7-9.0), and median lifetime number of times incarcerated was 6.5 (IQR 3.5-14.0). Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study. The most preferred Appointment Reminder message was Hey how you feeling? Don't forget to give a call and make your appointment (19/57, 33%). The most preferred Medication Adherence message was Don't forget your skittles! (31/57, 54%), and 63% (36/57) of participants chose to receive daily (vs weekly) messages from this category at baseline. The most preferred Prevention Reminder message was Stay strong. Stay clean (18/57, 32%). The most preferred Barriers to Care message was Holla at your case manager, they're here to help (12/57, 22%). Minor message preference differences were observed among participants enrolled in the jail versus those from the community.
CONCLUSIONS


Participants' ability to customize their SMS text message plan proved helpful. Further large-scale research on mHealth platforms is needed to assess its efficacy among HIV-infected persons with a history of incarceration.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721226; https://clinicaltrials.gov/ct2/show/NCT01721226.",2020,"Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study.","['HIV-infected persons', 'In Washington, District of Columbia (DC', 'HIV-infected persons with a history of incarceration', ' HIV-positive incarcerated individuals were recruited within the DC Department of Corrections, and persons released in the past 6 months were recruited within the community via street-based recruitment, community partnerships, and referrals', 'Median age was 42 years (IQR 30-50), 86% (49/57) were black or African American, 58% (33/57) were male, 25% (14/57) were female, and 18% (10/57) were transgender', 'From August 2013 to April 2015', 'Of the 112 participants enrolled, 57 (50.9', 'Persons Recently Released From Correctional Facilities']","['Mobile health (mHealth) interventions', 'SMS text messaging-based mHealth intervention (CARE+ Corrections', 'Text Messaging Intervention']","['Median length of last incarceration', 'median lifetime number of times incarcerated', 'Stay clean']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0012764', 'cui_str': 'Washington, D.C.'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442658', 'cui_str': 'Street (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",112.0,0.178996,"Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study.","[{'ForeName': 'Breana J', 'Initials': 'BJ', 'LastName': 'Uhrig Castonguay', 'Affiliation': 'University of North Carolina Center for AIDS Research, Lineberger Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Cressman', 'Affiliation': 'The Center for Prisoner Health and Human Rights, Providence, RI, United States.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuo', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'Rudy', 'Initials': 'R', 'LastName': 'Patrick', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trezza', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cates', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'Halli', 'Initials': 'H', 'LastName': 'Olsen', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Kurth', 'Affiliation': 'Yale University School of Nursing, New Haven, CT, United States.'}, {'ForeName': 'Lauri B', 'Initials': 'LB', 'LastName': 'Bazerman', 'Affiliation': 'The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Curt G', 'Initials': 'CG', 'LastName': 'Beckwith', 'Affiliation': 'The Miriam Hospital, Providence, RI, United States.'}]",JMIR mHealth and uHealth,['10.2196/16220']
2770,32052748,Music and pain during endorectal ultrasonography examination: A prospective questionnaire study and literature review.,"INTRODUCTION


Music interventions have been recognized as a method to reduce pain during medical procedures, but within medical imaging the subject has received little attention. Endorectal ultrasonography examination is in some patients associated with anxiety and pain, and since in Denmark pain relief is usually not administered by the Department of Radiology, it is important to find effective alternative methods to help patients manage their pain during imaging procedures. The primary aim of this study was to evaluate the effect of music on self-reported pain during endorectal examination of rectal cancer patients.
METHODS


A prospective questionnaire study of patients undergoing endorectal ultrasonography was conducted. Patients were randomized into two groups: a music group (n = 66), and non-music group (n = 60). Standard endorectal ultrasonography was performed in all patients. Pain was self-assessed using a Visual Analogue Scale ranging from 0 to 10, with 0 representing ""no pain"" and 10 maximum pain.
RESULTS


A total of 126 patients were included in the study, 81 (64.3%) men and 45 (35.7%) women. The demographics were similar in the two groups. The mean pain score during endorectal ultrasonography in the music and non-music group was 1.95 and 2.30, (p = 0.404).
CONCLUSION


In this randomized study music did not significantly affect the pain level experienced by the patients. Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
IMPLICATIONS FOR PRACTICE


Health care professionals may consider using music during painful procedures.",2020,"Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
","['rectal cancer patients', 'patients undergoing', 'A total of 126 patients were included in the study, 81 (64.3%) men and 45 (35.7%) women']","['endorectal ultrasonography examination', 'music group (n\xa0=\xa066), and non-music group', 'Standard endorectal ultrasonography', 'endorectal ultrasonography', 'Endorectal ultrasonography examination']","['pain level', 'Music and pain', 'mean pain score', 'Pain was self-assessed using a Visual Analogue Scale']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2315751', 'cui_str': 'Endorectal ultrasonography'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",126.0,0.0850938,"Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
","[{'ForeName': 'M R V', 'Initials': 'MRV', 'LastName': 'Pedersen', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Danish Colorectal Cancer Center South, Institute of Regional Health Research, University of Southern Denmark, Odense DK-5000, Denmark. Electronic address: malene.roland.vils.pedersen@rsyd.dk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dam', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Rafaelsen', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Danish Colorectal Cancer Center South, Institute of Regional Health Research, University of Southern Denmark, Odense DK-5000, Denmark.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.01.004']
2771,32052755,Optimisation of the lateral lumbar spine projection using an air-gap technique.,"INTRODUCTION


Lumbar spine radiography is considered as having a high radiation dose compared to other planar radiography examinations. The aim of this study was to investigate the feasibility of replacing an antiscatter grid with an air gap technique to achieve dose reduction for lateral lumbar spine radiography while maintaining image quality on a direct digital radiography (DDR) system.
METHODS


In phase 1, an experimental study using an anthropomorphic phantom identified the optimal airgap technique. In phase 2, lateral projections of the lumbar spine were performed on 50 patients randomly assigned equally into a control group (using the antiscatter grid) and an experimental group (using the airgap technique). The dose area product (DAP) was recorded, keeping other variables constant. Image quality evaluation was performed by 5 radiologists performing Absolute Visual Grading Analysis (VGA) using an image quality score tool, with resultant scores analysed using Visual Grading Characteristics (VGC).
RESULTS


A 10 cm airgap in conjunction with a source to image distance (SID) of 121 cm was found as the optimal airgap technique. The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%. Image quality scores were higher for the antiscatter grid but variation between the two techniques was not significant (p > 0.05).
CONCLUSION


Replacing the antiscatter grid with an airgap technique in lateral lumbar spine digital radiography, provides a significant dose reduction whilst still maintaining diagnostic image quality.
IMPLICATIONS FOR PRACTICE


The airgap technique is a simple and easy technique to implement and radiographers should find no difficulties in applying it, as It involves no additional cost and no additional equipment.",2020,The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%.,[],[],"['Image quality scores', 'Visual Grading Characteristics (VGC', 'dose area product (DAP']",[],[],"[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}]",50.0,0.0174193,The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bellizzi', 'Affiliation': 'Department of Radiography, Faculty of Health Sciences, University of Malta, Msida, Malta. Electronic address: andrea.bellizzi.15@um.edu.mt.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zarb', 'Affiliation': 'Department of Radiography, Faculty of Health Sciences, University of Malta, Msida, Malta. Electronic address: francis.zarb@um.edu.mt.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2019.12.008']
2772,31475507,Ultrasound-guided anterior quadratus lumborum block for postoperative pain after percutaneous nephrolithotomy: a randomized controlled trial.,"BACKGROUND


The Quadratus Lumborum Block (QLB), which is reported to provide analgesia to the abdominal region, is a newly defined fascial plane block method. The present study aimed to investigate the effect of ultrasound guided anterior QLB on the postoperative pain scores after percutaneous nephrolithotomy.
METHODS


In this prospective, randomized, controlled single-blind study, 60 patients with elective percutaneous nephrolithotomy operations were randomized into 2 groups. In Group B (n = 30): anterior QLB+ intravenous patient-controlled analgesia (PCA) morphine and in Group C (n = 30): intravenous PCA morphine. Outcome measures were included for visual analog scale (VAS) scores and morphine consumption for 24 hours postoperatively. Adverse effects, additional analgesic requirement, and intraoperative opioid requirement were recorded.
RESULTS


The mean values of the quantity of morphine used at the 6th, 12th, and 24th hours were found to be statistically significantly lower in Group B (p < 0.05). The VAS scores were found to be statistically significantly lower in Group B (p < 0.05). There were no statistically significant differences in the rate of adverse effects, additional analgesic requirement, and intraoperative opioid requirement between the groups (p > 0.05).
CONCLUSION


The study results suggest that anterior QLB is an effective treatment option for postoperative analgesia of percutaneous nephrolithotomy.",2020,"There was no statistically significant difference in the rate of adverse effects, additional analgesic requirement and intraoperative opioid requirement between the groups (p>0.05).
","['60 patients with elective percutaneous nephrolithotomy operations', 'postoperative pain after percutaneous nephrolithotomy']","['anterior QLB', 'anterior QLB+ intravenous patient-controlled analgesia (PCA) morphine', 'ultrasound-guided anterior QLB', 'Ultrasound-guided anterior quadratus lumborum block', 'PCA morphine']","['amount of morphine consumption and visual analog scale (VAS) scores', 'rate of adverse effects, additional analgesic requirement and intraoperative opioid requirement', 'VAS scores', 'mean values of the quantity of morphine', 'Adverse effects, additional analgesic requirement and intraoperative opioid requirement', 'postoperative pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",60.0,0.0686974,"There was no statistically significant difference in the rate of adverse effects, additional analgesic requirement and intraoperative opioid requirement between the groups (p>0.05).
","[{'ForeName': 'Korgün', 'Initials': 'K', 'LastName': 'Ökmen', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Yildirim, Bursa, Turkey.'}, {'ForeName': 'Burcu Metin', 'Initials': 'BM', 'LastName': 'Ökmen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Yildirim, Bursa, Turkey.'}]",Korean journal of anesthesiology,['10.4097/kja.19175']
2773,32052026,Efficacy and Spatial Extent of Yard-Scale Control of Aedes (Stegomyia) albopictus (Diptera: Culicidae) Using Barrier Sprays and Larval Habitat Management.,"The Asian tiger mosquito, Aedes (Stegomyia) albopictus (Skuse), is a peridomestic, container-ovipositing mosquito commonly found throughout the southeastern United States. In the United States, Ae. albopictus is typically considered a nuisance pest; however, it is capable of transmitting multiple pathogens. Ae. albopictus is an important pest species and the target of numerous mosquito control efforts in the United States. Here, we evaluate the effectiveness and spatial extent of Ae. albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting. Sixteen pairs of adjoining neighbors were randomly assigned to treatment groups with one neighbor receiving a treatment and the other monitored for evidence of a spillover effect of the treatments. Ae. albopictus populations in both yards were monitored for 33 d, with treatments occurring on the eighth day. Barrier sprays, both alone and combined with LHM, resulted in a significant reduction in Ae. albopictus abundance posttreatment. While LHM alone did not result in a significant reduction over the entire posttreatment period, Ae. albopictus populations were observed to be in decline during this period. No treatments were observed to have any reduction in efficacy 25 d posttreatment, with treatments involving LHM having a significantly increased efficacy. Yards neighboring treated yards were also observed to have reduced population sizes posttreatment, but these differences were rarely significant. These results provide insights into the population dynamics of Ae. albopictus following two common treatments and will be useful for integrated pest management plans.",2020,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.",['Sixteen pairs of adjoining neighbors'],"['bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM', 'Yard-Scale Control of Aedes (Stegomyia) albopictus ', 'LHM', 'Barrier Sprays and Larval Habitat Management']",['efficacy'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1553702', 'cui_str': 'Neighbor (person)'}]","[{'cui': 'C0390645', 'cui_str': 'bifenthrin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0871648', 'cui_str': 'Habitat'}, {'cui': 'C0560016', 'cui_str': 'yd3'}, {'cui': 'C0222045'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0261689,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Hawkins', 'Affiliation': 'The Mosquito Authority, LLC, Morrisville, NC.'}, {'ForeName': 'Alun L', 'Initials': 'AL', 'LastName': 'Lloyd', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Reiskind', 'Affiliation': 'Department of Entomology and Plant Pathology, North Carolina State University, Raleigh, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa016']
2774,31955491,Efficacy of exenatide and insulin glargine on nonalcoholic fatty liver disease in patients with type 2 diabetes.,"BACKGROUND


The aim of this study was to investigate the efficacy of exenatide and insulin glargine in patients with newly diagnosed type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD).
METHODS


We performed a 24-week randomized controlled multicentre clinical trial. Seventy-six patients were randomly assigned 1:1 to receive exenatide or insulin glargine treatment. The endpoints included changes in liver fat content (LFC), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) measured by magnetic resonance spectroscopy, blood glucose, liver enzymes, lipid profile, body weight, and Fibrosis-4 index (FIB-4).
RESULTS


LFC, VAT, SAT, and FIB-4 were significantly reduced after exenatide treatment (ΔLFC, -17.55 ± 12.93%; ΔVAT, -43.57 ± 68.20 cm 2  ; ΔSAT, -28.44 ± 51.48 cm 2  ; ΔFIB-4, -0.10 ± 0.26; all P < .05). In comparison, only LFC (ΔLFC, -10.49 ± 11.38%; P < .05), and not VAT, SAT, or FIB-4 index (all P > .05), was reduced after insulin glargine treatment. Moreover, exenatide treatment resulted in greater reductions in alanine transaminase (ALT), aspartate transaminase (AST), and gamma glutamyl transpeptidase (GGT) than insulin glargine (P < 0.05). The body weight, waist circumference, postprandial plasma glucose, and low-density lipoprotein cholesterol (LDL-C) in the exenatide group also presented greater reductions than the insulin glargine group (P < .05). The proportion of adverse events were comparable between the two groups.
CONCLUSION


Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.",2020,"Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.","['Seventy-six patients', 'patients with newly diagnosed type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD', 'Patients with Type 2 Diabetes Mellitus', 'patients with drug-naive T2DM and NAFLD']","['exenatide or insulin glargine treatment', 'Exenatide and Insulin Glargine', 'exenatide and insulin glargine', 'insulin glargine', 'exenatide']","['not VAT, SAT, or FIB-4 index', 'body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C', 'proportion of adverse events', 'body weight, waist circumference, postprandial plasma glucose, and low-density lipoprotein cholesterol (LDL-C', 'changes in liver fat content (LFC), visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) measured by magnetic resonance spectroscopy, blood glucose, liver enzymes, lipid profile, body weight, and FIB-4 index (FIB-4', 'Nonalcoholic Fatty Liver Disease', 'LFC, VAT, SAT, and FIB-4', 'alanine transaminase (ALT), aspartate transaminase (AST), and gamma glutamyl transpeptidase (GGT']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}]",76.0,0.036181,"Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'MingFeng', 'Initials': 'M', 'LastName': 'Xia', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Naiqin', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Shengxiang', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiuzhong', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Baishen', 'Initials': 'B', 'LastName': 'Pan', 'Affiliation': 'Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3292']
2775,32039876,Effects of multi-session intermittent theta burst stimulation on central neuropathic pain: A randomized controlled trial.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) is one of the effective treatments for neuropathic pain. Little is known about the effects of multi-session theta burst stimulation, one of the new paradigms of rTMS.
OBJECTIVE


The aim of this study was to investigate the effects of multi-session intermittent theta burst stimulation (iTBS) on central neuropathic pain, using evaluation tools specific to neuropathic pain.
METHODS


Patients with central neuropathic pain diagnosed using Neuropathic Pain Special Interest Group guidelines were recruited. Thirty patients were randomly assigned to either a real or sham iTBS group. Each patient underwent 5 sessions of iTBS; before and after completion of the 5 sessions, participants were evaluated using the self-completed Leeds assessment of neuropathic symptoms and signs (S-LANSS), the numeric rating scale (NRS), the neuropathic pain symptom inventory (NPSI), and the neuropathic pain scale (NPS).
RESULTS


S-LANSS, NRS, NPSI, and 3 of 4 NPS combination scores decreased significantly in the real iTBS group but not in the sham iTBS group. No adverse effects were reported during or after iTBS sessions.
CONCLUSIONS


Multi-session iTBS was associated with a significant decrease in neuropathic pain, indicating its effectiveness as a treatment for patients with central neuropathic pain.",2020,"No adverse effects were reported during or after iTBS sessions.
","['Thirty patients', 'Patients with central neuropathic pain diagnosed using Neuropathic Pain Special Interest Group guidelines were recruited', 'patients with central neuropathic pain']","['Repetitive transcranial magnetic stimulation (rTMS', 'multi-session intermittent theta burst stimulation (iTBS', 'multi-session intermittent theta burst stimulation', 'real or sham iTBS']","['NPS combination scores', 'adverse effects', 'central neuropathic pain', 'neuropathic pain', 'neuropathic symptoms and signs (S-LANSS), the numeric rating scale (NRS), the neuropathic pain symptom inventory (NPSI), and the neuropathic pain scale (NPS']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0021729', 'cui_str': 'Interest Groups'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.165199,"No adverse effects were reported during or after iTBS sessions.
","[{'ForeName': 'Jong Keun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyo Sik', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Bae', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Yong Sung', 'Initials': 'YS', 'LastName': 'Jeong', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Kang Jae', 'Initials': 'KJ', 'LastName': 'Jung', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Jong Youb', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Eulji University Hospital, Daejeon, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-192958']
2776,31698336,Evaluation of Step-Counting Interventions Differing on Intensity Messages.,"BACKGROUND


Step-counting interventions with discrepant intensity emphases may elicit different effects.
METHODS


A total of 120 sedentary/low-active, postmenopausal women were randomly assigned to one of the following 3 groups: (1) 10,000 steps per day (with no emphasis on walking intensity/speed/cadence; basic intervention, 49 completers), (2) 10,000 steps per day and at least 30 minutes in moderate intensity (ie, at a cadence of at least 100 steps per minute; enhanced intervention, 47 completers), or (3) a control group (19 completers). NL-1000-determined steps and active minutes (a device-specific indicator of time at moderate+ intensity) were collected as process variables during the 12-week intervention. Outcome variables included systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior.
RESULTS


The ""basic group"" increased 5173 to 9602 steps per day and 9.2 to 30.2 active minutes per day. The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day. The only significant change over time for clinical variables was body mass index.
CONCLUSIONS


Interventions that use simple step-counters can achieve elevated volume and intensity of daily physical activity, regardless of emphasis on intensity. Despite this, few clinical outcomes were apparent in this sample of postmenopausal women with generally normal or controlled hypertension.",2020,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","['120 sedentary/low-active, postmenopausal women', 'postmenopausal women with generally normal or controlled hypertension']",[],"['systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior', 'elevated volume and intensity of daily physical activity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",120.0,0.0543753,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","[{'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Schuna', 'Affiliation': ''}, {'ForeName': 'Damon L', 'Initials': 'DL', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Amber T', 'Initials': 'AT', 'LastName': 'Dragg', 'Affiliation': ''}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0439']
2777,32035514,"Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Pembrolizumab plus pemetrexed-platinum led to superior overall survival and progression-free survival, and a higher proportion of patients with a confirmed complete or partial response over placebo plus pemetrexed-platinum in the KEYNOTE-189 study. We aimed to evaluate prespecified exploratory patient-reported outcomes (PROs) in patients in KEYNOTE-189.
METHODS


In the multicentre, double-blind, randomised, placebo-controlled, phase 3 KEYNOTE-189 study done at 126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled. Patients were randomly assigned (2:1) to receive intravenous pembrolizumab (200 mg) or saline placebo every 3 weeks for up to 2 years (35 cycles); all patients received four cycles of intravenous pemetrexed (500 mg/m 2 ) with carboplatin (5 mg/mL per min) or cisplatin (75 mg/m 2 ; investigator's choice) every 3 weeks for four cycles, followed by pemetrexed maintenance therapy every 3 weeks. Permuted block randomisation (block size six) was done with an interactive voice-response system and stratified by PD-L1 expression, choice of platinum, and smoking status. Patients, investigators, and other study personnel were unaware of treatment assignment. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) were administered at cycles 1-5, every three cycles thereafter during year 1, and every four cycles during years 2-3. The primary endpoints (overall survival and progression-free survival) have been published previously. Key PRO endpoints were change from baseline to week 12 (during chemotherapy) and week 21 (following chemotherapy) in QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea. PROs were analysed in all randomly assigned patients who received at least one dose of study medication and who completed at least one PRO assessment, and the results are provided with two-sided, nominal p values. This ongoing study is registered with ClinicalTrials.gov, number NCT02578680.
FINDINGS


Between Feb 26, 2016, and March 6, 2017, 616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017. 402 (99%) of 405 patients in the pembrolizumab plus pemetrexed-platinum group and 200 (99%) of 202 patients in the placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment. At baseline, 359 (89%) of 402 patients in the pembrolizumab plus pemetrexed-platinum group and 180 (90%) of 200 in the placebo plus pemetrexed-platinum group were compliant with QLQ-C30; at week 12, 319 (90%) of 354 and 149 (89%) of 167 patients were compliant, respectively; and at week 21, 249 (76%) of 326 and 91 (64%) of 143 patients were compliant, respectively. From baseline to week 12, GHS/QOL scores were maintained with both pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·0 point [95% CI -1·3 to 3·2] increase) and placebo plus pemetrexed-platinum (-2·6 points [-5·8 to 0·5] decrease; between-group difference: 3·6 points [-0·1 to 7·2]; p=0·053). From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014). Median time to deterioration in cough, chest pain, or dyspnoea was not reached (95% CI 10·2 months to not reached) with pembrolizumab plus pemetrexed-platinum, and was 7·0 months (4·8 months to not reached) with placebo plus pemetrexed-platinum (hazard ratio 0·81 [95% CI 0·60-1·09], p=0·16).
INTERPRETATION


The addition of pembrolizumab to standard chemotherapy maintained GHS/QOL, with improved GHS/QOL scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed-platinum as first-line therapy for patients with metastatic non-squamous non-small-cell lung cancer.
FUNDING


Merck Sharp & Dohme.",2020,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","['patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189', '126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1), and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled', 'patients with metastatic non-squamous non-small-cell lung cancer', 'Between Feb 26, 2016, and March 6, 2017', 'patients in KEYNOTE-189', '616 patients were enrolled; median follow-up was 10·5 months (range 0·2-20·4) as of data cutoff on Nov 8, 2017']","['pembrolizumab plus pemetrexed-platinum', 'pembrolizumab plus chemotherapy', 'saline placebo', 'pembrolizumab or placebo plus pemetrexed and platinum', 'intravenous pembrolizumab', 'placebo', 'Pembrolizumab plus pemetrexed-platinum', 'intravenous pemetrexed', 'placebo plus pemetrexed-platinum-treated group completed at least one PRO assessment', 'placebo plus chemotherapy', 'placebo plus pemetrexed-platinum', 'cisplatin', 'carboplatin', 'placebo-controlled', 'pembrolizumab']","['Median time to deterioration in cough, chest pain, or dyspnoea', 'QLQ-C30 global health status/quality of life (GHS/QOL) score, and time to deterioration in cough, chest pain, or dyspnoea', 'GHS/QOL scores', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",616.0,0.745602,"From baseline to week 21, GHS/QOL scores were better maintained with pembrolizumab plus pemetrexed-platinum (least-squares mean change: 1·3 points [95% CI -1·2 to 3·6] increase) than with placebo plus pemetrexed-platinum (-4·0 points [-7·7 to -0·3] decrease; between-group difference: 5·3 points [1·1 to 9·5]; p=0·014).","[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: marina.garassino@istitutotumori.mi.it.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Medical Oncology 1, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Esteban', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'Centre Intégré de Cancérologie de la Montérégie, Hôpital Charles-Le Moyne, Greenfield Park, QC, Canada.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Health, Sioux Falls, SD, USA.'}, {'ForeName': 'Susanna Yee-Shan', 'Initials': 'SY', 'LastName': 'Cheng', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Helge G', 'Initials': 'HG', 'LastName': 'Bischoff', 'Affiliation': 'Thoraxklinik, Heidelberg, Germany.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'Clalit Health Services, Soroka Medical Center, Beer-Sheeva, Israel.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30801-0']
2778,32014055,"Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial.","BACKGROUND


Cerebral palsy (CP) is a syndrome of childhood movement and posture disorders. Clinical evidence is still limited and sometimes inconclusive about the benefits of human umbilical cord mesenchymal stem cells (hUC-MSCs) for CP. We conducted a randomized trial to evaluate the safety and efficacy of hUC-MSC transplantation concomitant with rehabilitation in patients with CP.
METHODS


Eligible patients were allocated into the hUC-MSC group and control group. In addition to rehabilitation, the patients in the hUC-MSC group received four transfusions of hUC-MSCs intravenously, while the control group received a placebo. Adverse events (AEs) were collected for safety evaluation in the 12-month follow-up phase. Primary endpoints were assessed as activities of daily living (ADL), comprehensive function assessment (CFA), and gross motor function measure (GMFM) scales. In addition, cerebral metabolic activity was detected by  18 F-FDG-PET/CT to explore the possible mechanism of the therapeutic effects. Primary endpoint data were analyzed by ANOVA using SPSS version 20.0.
RESULTS


Forty patients were enrolled, and 1 patient withdrew informed consent. Therefore, 39 patients received treatments and completed the scheduled assessments. No significant difference was shown between the 2 groups in AE incidence. Additionally, significant improvements in ADL, CFA, and GMFM were observed in the hUC-MSC group compared with the control group. In addition, the standard uptake value of  18 F-FDG was markedly increased in 3 out of 5 patients from the hUC-MSC group at 12 months after transplantation.
CONCLUSIONS


Our clinical data showed that hUC-MSC transplantation was safe and effective at improving the gross motor and comprehensive function of children with CP when combined with rehabilitation. Recovery of cerebral metabolic activity might play an essential role in the improvements in brain function in patients with CP. The therapeutic window, transfusion route, and dosage in our study were considerable for reference in clinical application.
TRIAL REGISTRATION


Chictr.org.cn, ChiCTR1800016554. Registered 08 June 2018-retrospectively registered. The public title was ""Randomized trial of umbilical cord-derived mesenchymal stem cells for cerebral palsy.""",2020,"Additionally, significant improvements in ADL, CFA, and GMFM were observed in the hUC-MSC group compared with the control group.","['39 patients received treatments and completed the scheduled assessments', 'cerebral palsy', 'patients with CP', 'Forty patients were enrolled, and 1 patient withdrew informed consent', 'Eligible patients']","['umbilical cord-derived mesenchymal stem cell transplantation', 'hUC-MSC transplantation concomitant with rehabilitation', 'hUC-MSC transplantation', 'umbilical cord-derived mesenchymal stem cells', 'hUC-MSC', 'placebo']","['activities of daily living (ADL), comprehensive function assessment (CFA), and gross motor function measure (GMFM) scales', 'standard uptake value of  18 F-FDG', 'Adverse events (AEs', 'safety and efficacy', 'ADL, CFA, and GMFM', 'cerebral metabolic activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C1257990', 'cui_str': 'Mesenchymal Stem Cell Transplantation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",40.0,0.151594,"Additionally, significant improvements in ADL, CFA, and GMFM were observed in the hUC-MSC group compared with the control group.","[{'ForeName': 'Jiaowei', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': ""Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Che', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Ruibo', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Ziliang', 'Initials': 'Z', 'LastName': 'Tu', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Hengdong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Xihui', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China.""}, {'ForeName': 'Zhousheng', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, 38163, USA.'}, {'ForeName': 'Zegan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Shenzhen Beike Biotechnology Co., Ltd, No. 18 Keyuan Road, Hi-Tech Industrial Park South Area, Shenzhen, 518057, People's Republic of China.""}, {'ForeName': 'Zunchen', 'Initials': 'Z', 'LastName': 'Ke', 'Affiliation': ""Shiyan City Disabled Persons' Federation, No. 12 Beijing Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Dabin', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China. liuli918@163.com.""}]",Stem cell research & therapy,['10.1186/s13287-019-1545-x']
2779,32041914,Effect of Oral N-Acetylcysteine Supplementation on the Immunity System in Patients with Acute Myocardial Infarction.,"BACKGROUND


inflammation, oxidative stress, and fibrosis play important roles after an acute myocardial infarction (AMI) event. The most studied inflammatory biomarker in cardiovascular disease is C-reactive protein (CRP). It has been demonstrated that myeloperoxidase (MPO) and Galectin-3 (Gal-3) have some essential roles on immune system when an AMI event occurs. We aimed to determine the effect of oral N-acetylcysteine (NAC) supplementation at the dose of 600 mg 3 times daily for 3 consecutive days on the immune system of AMI patients.
METHODS


our randomized single-blinded experimental study using pre- and post-treatment evaluations was performed at Dr. Moewardi Hospital, Indonesia, from May to August 2018. Thirty-two patients with AMI and ST segment elevation (STEMI) who received fibrinolytic therapy were included. There were 17 patients received standard therapy plus 600 mg oral NAC supplementation every 8 h for 3 days and 15 patients received standard therapy, which served as the control group. High-sensitivity C-reactive protein (HsCRP), MPO, and Gal-3 levels of both groups were evaluated at admission and after 72 h receiving treatment.
RESULTS


HsCRP, MPO, and Gal-3 levels between NAC and control groups at admission were not significantly different; while intergroup differences after 72 h of NAC supplementation were significant (p values of HsCRP, MPO, and Gal-3 levels were 0.0001, 0.001, and 0.017, respectively). Furthermore, in the NAC group, HsCRP, MPO, and Gal-3 levels at 72 h after treatment were significantly different from the corresponding levels at admission (p values: 0.0001, 0.0001, and 0.0001, respectively); the control group did not show these differences. There were also significant intergroup differences between the NAC and control groups regarding HsCRP, MPO, and Gal-3 levels (p values: 0.011, 0.022, and 0.014, respectively).
CONCLUSION


oral supplementation of 600 mg NAC every 8 h for 72 h can reduce HsCRP, MPO, and Gal-3 levels in AMI patients receiving fibrinolytic therapy. Results of our study will provide more options for supplementation therapy to improve management of IMA patients.",2019,"There were also significant intergroup differences between the NAC and control groups regarding HsCRP, MPO, and Gal-3 levels (p values: 0.011, 0.022, and 0.014, respectively).
","['AMI patients', 'Thirty-two patients with AMI and ST segment elevation (STEMI) who received', 'IMA patients', 'AMI patients receiving fibrinolytic therapy', 'Patients with Acute Myocardial Infarction']","['Oral N-Acetylcysteine Supplementation', 'standard therapy plus 600 mg oral NAC supplementation', 'oral N-acetylcysteine (NAC) supplementation', 'fibrinolytic therapy']","['HsCRP, MPO, and Gal-3 levels', 'High-sensitivity C-reactive protein (HsCRP), MPO, and Gal-3 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}]","[{'cui': 'C0912079', 'cui_str': 'myelopoietin'}, {'cui': 'C1705853', 'cui_str': 'Imperial gallon'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",32.0,0.0534501,"There were also significant intergroup differences between the NAC and control groups regarding HsCRP, MPO, and Gal-3 levels (p values: 0.011, 0.022, and 0.014, respectively).
","[{'ForeName': 'Trisulo', 'Initials': 'T', 'LastName': 'Wasyanto', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine, Sebelas Maret University - Dr. Moewardi Hospital, Surakarta, Indonesia. trisulo.wasyanto@gmail.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': ""Yasa'"", 'Affiliation': ''}, {'ForeName': 'Akhmad', 'Initials': 'A', 'LastName': 'Jalaludinsyah', 'Affiliation': ''}]",Acta medica Indonesiana,[]
2780,31744313,Comparison Between Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection for Plantar Fasciitis.,"BACKGROUND


Extracorporeal shock wave therapy (ESWT) is a nonsurgical treatment for plantar fasciitis (PF) that has had satisfactory clinical outcomes. However, local corticosteroid injection (LCI) is often regarded as first-line treatment of PF, but there have been few studies comparing the 2 methods. Therefore, we compared the effect of ESWT and LCI on patients with PF.
METHODS


This was a block randomized controlled study comparing 49 patients treated with ESWT and 47 patients treated with LCI from January 2017 to December 2018 who were followed for 6 months. We evaluated the clinical outcomes in the 2 groups, including average pain, first-step pain, plantar fascia thickness, and Foot Function Index, Chinese version of the PF patients.
RESULTS


All patients had pain relief and function improvement after treatment, whereas the LCI group did not maintain significant clinical improvement at the 3-month follow-up. The patients in the ESWT group had a significantly better clinical outcome with better duration of improvement than the LCI group.
CONCLUSION


For PF patients, both ESWT and LCI resulted in clinical improvement but EWST provided longer relief than LCI.
LEVEL OF EVIDENCE


Level II, prospective comparative study.",2020,"For PF patients, both ESWT and LCI resulted in clinical improvement but EWST provided longer relief than LCI.
","['49 patients treated with ESWT and 47 patients treated with LCI from January 2017 to December 2018 who were followed for 6 months', 'patients with PF', 'Plantar Fasciitis', 'plantar fasciitis (PF']","['ESWT and LCI', 'local corticosteroid injection (LCI', 'Extracorporeal shock wave therapy (ESWT', 'Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection']","['average pain, first-step pain, plantar fascia thickness, and Foot Function Index, Chinese version of the PF patients', 'pain relief and function improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0386467,"For PF patients, both ESWT and LCI resulted in clinical improvement but EWST provided longer relief than LCI.
","[{'ForeName': 'Dingli', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Ningbo University Medical School, Ningbo, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Dichao', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Gan', 'Affiliation': 'Ningbo City Medical Treatment Center Lihuili Hospital, Ningbo, China.'}, {'ForeName': 'Weihu', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Ningbo No. 6 Hospital, Ningbo, China.'}]",Foot & ankle international,['10.1177/1071100719891111']
2781,31867770,Use of peripheral plasma aldosterone concentration and response to ACTH during simultaneous bilateral adrenal veins sampling to predict the source of aldosterone secretion in primary aldosteronism.,"CONTEXT


Previous studies suggested that plasma aldosterone (PAC) response to ACTH stimulation could predict the subtypes of primary aldosteronism (PA) and avoid adrenal venous sampling (AVS).
OBJECTIVE


Assess the usefulness of peripheral (P) PAC response to ACTH stimulation during AVS to identify the source of aldosterone in patients with PA.
METHODS


Two hundred and fifteen patients were assigned to four different lateralization ratio (LR) groups based on different combinations of basal (≥ or <2) and post-ACTH LR (≥ or <4). The P vein parameters analysed included as follows: mean basal PAC, maximal PAC (PAC max  ), and PAC/C ratio (PAC max  /C), PAC absolute increase, PAC relative increase following ACTH bolus (250 mcg IV) and maximal variation of PAC/C ratio between post-ACTH and basal measures.
RESULTS


Mean basal PAC was significantly higher in group 1 (basal LR > 2 and post-ACTH > 4) than in group 2 (basal LR > 2, post-ACTH < 4) or group 4 (basal LR < 2 post-ACTH < 4) (P < .001). PAC max  , PAC max  /C and PAC absolute increase following ACTH were higher in group 1 than the others (P < .017). Using receiver operating characteristic (ROC) curves analysis of groups 1 and 4, best AUC were obtained with mean basal PAC (AUC: 0.757 95% IC: 0.653-0.861), PAC max  (AUC: 0.753 95% IC: 0.646-0.860) and PAC max  /C (AUC: 0.750 95% IC: 0.646-0.853).
CONCLUSION


P mean basal PAC and PAC max  and PAC max  /C are higher in basal and ACTH lateralized PA than in other groups. Peripheral PAC cut-off values fail to adequately distinguish all groups and cannot replace the requirement to conduct AVS.",2020,"PAC max  , PAC max  /C and PAC absolute increase following ACTH were higher in group 1 than the others (P < .017).","['primary aldosteronism', 'patients with PA', 'Two hundred and fifteen patients were assigned to four different lateralization ratio (LR) groups based on different combinations of basal (≥ or <2) and']","['ACTH', 'post-ACTH LR']","['Mean basal PAC', 'P mean basal PAC and PAC max  and PAC max  /C', 'mean basal PAC, maximal PAC (PAC max  ), and PAC/C ratio (PAC max  /C), PAC absolute increase, PAC relative increase', 'plasma aldosterone (PAC) response', 'PAC max', 'PAC max  , PAC max  /C and PAC absolute increase following ACTH', 'maximal variation of PAC/C ratio']","[{'cui': 'C1384514', 'cui_str': 'Primary Hyperaldosteronism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",215.0,0.0227586,"PAC max  , PAC max  /C and PAC absolute increase following ACTH were higher in group 1 than the others (P < .017).","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'St-Jean', 'Affiliation': ""Division of Endocrinology, Department of Medicine and Research Center, Centre hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bourdeau', 'Affiliation': ""Division of Endocrinology, Department of Medicine and Research Center, Centre hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Therasse', 'Affiliation': ""Division of Diagnostic Radiology, Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Division of Endocrinology, Department of Medicine and Research Center, Centre hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.""}]",Clinical endocrinology,['10.1111/cen.14137']
2782,31930364,Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.,"Importance


RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders.
Objective


To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults.
Design, Setting, and Participants


This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4.
Exposures


Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60).
Main Outcomes and Measures


Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period.
Results


Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries.
Conclusions and Relevance


Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01994109.",2020,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","['187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years', 'A total of 176 completed the study', '122 patients had Parkinson disease (65.2%), 13 (7.0', 'Sialorrhea in Adults', '249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened', 'Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled', 'people with neurological disorders', 'sialorrhea in adults']","['RIMA', 'RIMA injections', 'RimabotulinumtoxinB', 'placebo', 'RimabotulinumtoxinB (RIMA']","['adult cerebral palsy', 'amyotrophic lateral sclerosis', 'Safety and Efficacy', 'change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C', 'tolerated and reduced sialorrhea', 'Adverse events', 'safety, efficacy, and tolerability', 'CGI-C scores', 'USFR', 'minimum Drooling Frequency and Severity Scale score of 4', 'minimum unstimulated salivary flow rate (USFR']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2719430', 'cui_str': 'rimabotulinumtoxinB'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}]",249.0,0.347529,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, Texas.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Trosch', 'Affiliation': 'Franklin Neurology, Farmington Hills, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Molho', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center, Albany Medical Center, Albany, New York.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': 'US WorldMeds LLC, Louisville, Kentucky.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4565']
2783,32031887,"Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303.","Background:  We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies.  Methods:  We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n  = 195) or usual oncology care ( n  = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. The primary endpoint was the change in quality of life from baseline to week 12 per the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes included anxiety, depression, and communication about prognosis and end-of-life care.  Results:  Due to significant morbidity and a high proportion of measures that were not completed within the protocol window or for unknown reasons, the rate of missing data was high. We anticipated that 70% of patients ( n  = 280) would complete the FACT-G at baseline and week 12, but only 49.3% ( n  = 193/391) completed the measure. Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12. Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline ( p  = 0.10).  Conclusion:  This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.",2020,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","['patients with advanced cancer', 'patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n \u2009=\u2009195) or usual oncology care ( n \u2009=\u2009196) at sites through the Alliance for Clinical Trials in Oncology', 'Patients with Advanced Lung and Gastrointestinal Cancer', 'patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies']","['Early Integrated Palliative and Oncology Care', 'early integrated palliative and oncology care', 'supportive care interventions']","['FACT-G scores', 'Functional Assessment of Cancer Therapy-General (FACT-G', 'change in quality of life', 'anxiety, depression, and communication about prognosis and end-of-life care', 'PC visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}]",,0.147398,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Blinderman', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Strand', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Zylla', 'Affiliation': 'Park Nicollet/HealthPartners, Metro-Minnesota Community Oncology Research Consortium, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Daugherty', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Muhummad', 'Initials': 'M', 'LastName': 'Furqan', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'NorthShore University HealthSystem CCOP, Evanston, Illinois, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Razaq', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roeland', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla, California, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0377']
2784,32033227,Improving Screening Uptake among Breast Cancer Survivors and Their First-Degree Relatives at Elevated Risk to Breast Cancer: Results and Implications of a Randomized Study in the State of Georgia.,"Women diagnosed with breast cancer at a relatively early age (≤45 years) or with bilateral disease at any age are at elevated risk for additional breast cancer, as are their female first-degree relatives (FDRs). We report on a randomized trial to increase adherence to mammography screening guidelines among survivors and FDRs. From the Georgia Cancer Registry, breast cancer survivors diagnosed during 2000-2009 at six Georgia cancer centers underwent phone interviews about their breast cancer screening behaviors and their FDRs. Nonadherent survivors and FDRs meeting all inclusion criteria were randomized to high-intensity (evidence-based brochure, phone counseling, mailed reminders, and communications with primary care providers) or low-intensity interventions (brochure only). Three and 12-month follow-up questionnaires were completed. Data analyses used standard statistical approaches. Among 1055 survivors and 287 FDRs who were located, contacted, and agreed to participate, 59.5% and 62.7%, respectively, reported breast cancer screening in the past 12 months and were thus ineligible. For survivors enrolled at baseline ( N  = 95), the proportion reporting adherence to guideline screening by 12 months post-enrollment was similar in the high and low-intensity arms (66.7% vs. 79.2%,  p  = 0.31). Among FDRs enrolled at baseline ( N  = 83), screening was significantly higher in the high-intensity arm at 12 months (60.9% vs. 32.4%,  p  = 0.03). Overall, about 72% of study-eligible survivors (all of whom were screening nonadherent at baseline) reported screening within 12 months of study enrollment. For enrolled FDRs receiving the high-intensity intervention, over 60% reported guideline screening by 12 months. A major conclusion is that using high-quality central cancer registries to identify high-risk breast cancer survivors and then working closely with these survivors to identify their FDRs represents a feasible and effective strategy to promote guideline cancer screening.",2020,"Among FDRs enrolled at baseline ( N  = 83), screening was significantly higher in the high-intensity arm at 12 months (60.9% vs. 32.4%,  ","['1055 survivors and 287 FDRs who were located, contacted, and agreed to participate, 59.5% and 62.7%, respectively, reported breast cancer screening in the past 12 months and were thus ineligible', 'survivors and FDRs', 'Breast Cancer Survivors and Their First-Degree Relatives at Elevated Risk to Breast Cancer', 'Women diagnosed with breast cancer at a relatively early age (≤45 years) or with bilateral disease at any age are at elevated risk for additional breast cancer, as are their female first-degree relatives (FDRs']","['high-intensity (evidence-based brochure, phone counseling, mailed reminders, and communications with primary care providers) or low-intensity interventions (brochure only', 'phone interviews about their breast cancer screening behaviors and their FDRs', 'mammography screening guidelines']",['proportion reporting adherence to guideline screening'],"[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",6.0,0.0362967,"Among FDRs enrolled at baseline ( N  = 83), screening was significantly higher in the high-intensity arm at 12 months (60.9% vs. 32.4%,  ","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lipscomb', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Cam', 'Initials': 'C', 'LastName': 'Escoffery', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Gillespie', 'Affiliation': 'Winship Cancer Institute of Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'S Jane', 'Initials': 'SJ', 'LastName': 'Henley', 'Affiliation': 'Division of Cancer Prevention and Control, U.S. Centers for Disease Control and Prevention; Atlanta, GA 30341, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Chociemski', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Almon', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Renjian', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Ward', 'Affiliation': 'Rollins School of Public Health, Emory University; Atlanta, GA 30322, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17030977']
2785,32041577,"Theory of mind, emotion recognition, delusions and the quality of the therapeutic relationship in patients with psychosis - a secondary analysis of a randomized-controlled therapy trial.","BACKGROUND


Cognitive models of psychosis postulate an important role of Theory of mind (ToM) in the formation and maintenance of delusions, but research on this plausible conjecture has gathered conflicting findings. In addition, it is still an open question whether problems in emotion recognition (ER) are associated with delusions. We examined the association of problems in ToM and ER with different aspects of delusions in a large sample of patients with psychosis enrolled in a therapy trial. This also enabled us to explore the possible impact of ToM and ER on one part of patients' social life: the quality of their therapeutic relationship.
METHODS


Patients with psychotic disorders and delusions and/or hallucinations (n = 185) and healthy controls (n = 48) completed a ToM picture sequencing task and an ER task. Subsequently, patients were enrolled in a randomized-controlled Cognitive Behavior Therapy (CBT) trial (ISRCTN29242879). Patients and therapists rated the quality of the therapeutic relationship during the first five sessions of therapy.
RESULTS


In comparison to controls, patients were impaired in both ToM and ER. Patients with deficits in ER experienced more severe delusional distress, whereas ToM problems were not related to delusions. In addition, deficits in ER predicted a less favorable therapeutic relationship and interactional problems viewed by the therapist. Impaired ER also moderated (increased) the negative influence of delusions on the therapeutic relationship and interactional difficulties viewed by the therapist.
CONCLUSIONS


Cognitive models on the formation and maintenance of delusions should consider ER as a potential candidate that might be related to the formation and maintenance of delusional distress, whereas problems in ToM might not be directly related to delusions and secondary dimensions of delusions. In addition, problems in ER in patients with psychosis might have an impact on the quality of the therapeutic relationship and patients with problems in ER are more likely to be viewed as problematic by their therapists. Nevertheless, training ER might be a way to improve the quality of the therapeutic relationship and potentially the effectiveness of CBT or other interventions for patients with psychosis.",2020,"In comparison to controls, patients were impaired in both ToM and ER.","['Patients with psychotic disorders and delusions and/or hallucinations (n\u2009=\u2009185) and healthy controls (n\u2009=\u200948) completed a', 'patients with psychosis', 'patients with psychosis ', 'patients with psychosis enrolled in a therapy trial']","['ToM picture sequencing task and an ER task', 'ToM and ER', 'CBT']","['ToM problems', 'severe delusional distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0353459,"In comparison to controls, patients were impaired in both ToM and ER.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Bonn, Sigmund-Freud-Straße 25, 53105, Bonn, Germany. stephanie.mehl@staff.uni-marburg.de.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hesse', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Anna-Christine', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Bonn, Sigmund-Freud-Straße 25, 53105, Bonn, Germany.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Landsberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Bonn, Sigmund-Freud-Straße 25, 53105, Bonn, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soll', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University of Marburg, Rudolf-Bultmann-Straße 8, 35039, Marburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Gleuler Straße, 50931, Köln, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Herrlich', 'Affiliation': 'Department of Psychiatry, Psychosomatic and Psychotherapy, University of Frankfurt, Heinrich-Hoffmann-Straße 10, 60528, Frankfurt am Main, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University of Marburg, Rudolf-Bultmann-Straße 8, 35039, Marburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klingberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Bernhard W', 'Initials': 'BW', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Duisburg- Essen, Virchowstraße 147, 45147, Essen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Hospital Fulda, Pacelliallee 4, 36043, Fulda, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wittorf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wölwer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University of Düsseldorf, Bergische Landstraße 2, 40629, Düsseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Bonn, Sigmund-Freud-Straße 25, 53105, Bonn, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-2482-z']
2786,31494058,Access With Education Improves Fruit and Vegetable Intake in Preschool Children.,"OBJECTIVE


To compare effects of interventions aimed at increasing fruit and vegetable (FV) intake in children.
DESIGN


Pre-post comparison and intervention study with randomly grouped classrooms.
SETTING


Head Start classrooms.
PARTICIPANTS


Two hundred nine Head Start children.
INTERVENTIONS


Treatment A (n = 61) and treatment B (n = 82) children received high-carotenoid FVs for 8 weeks. Treatment B children also received weekly FV education, and their caregivers received FV information and recipes. The comparison group (n = 66) received neither FVs nor education.
MAIN OUTCOME MEASURE


Carotenoid values in Raman units.
ANALYSIS


Multilevel mixed models, ANCOVA, and post hoc analysis were used.
RESULTS


Multilevel mixed models with the group as fixed effect and classrooms within group as a random effect; ANCOVA showed that the only significant variable affecting the score was the group main effect. The intraclass correlation coefficient was 0.037; the Raman unit scores of treatment B were significantly higher than those of treatment A (P = .02) or comparison group (P < .001). However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71).
CONCLUSIONS AND IMPLICATIONS


The results suggested that providing education where FVs are offered may help increase consumption. Measurement of carotenoids in family members who received FVs plus education, as well as replication of this model in different locations and ages of children should be investigated in future research.",2020,"However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71).
","['children', 'Two hundred nine Head Start children', 'Head Start classrooms', 'Preschool Children']","['high-carotenoid FVs', 'Education Improves Fruit and Vegetable Intake', 'FVs nor education']","['Carotenoid values in Raman units', 'fruit and vegetable (FV) intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]","[{'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",209.0,0.0395194,"However, there was no significant difference between treatment A and comparison (P = .10; Cohen D = .71).
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Department of Human Sciences, College of Behavioral and Health Sciences, Middle Tennessee State University, Murfreesboro, TN. Electronic address: Elizabeth.Ann.Smith@mtsu.edu.'}, {'ForeName': 'Toto', 'Initials': 'T', 'LastName': 'Sutarso', 'Affiliation': 'Information Technology Division, Middle Tennessee State University, Murfreesboro, TN.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Kaye', 'Affiliation': 'Division of Health Behavior and Health Promotion, College of Public Health, Ohio State University, Columbus, OH.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.07.016']
2787,31563659,Awake Sedation With Propofol Attenuates Intraoperative Stress of Carotid Endarterectomy in Regional Anesthesia.,"BACKGROUND


Carotid endarterectomy in regional anesthesia is often associated with increased perioperative stress. We assumed that carotid endarterectomy performed under awake sedation with propofol is more beneficial to prevent such stress than alprazolam premedication only.
METHODS


A total of 47 consecutive patients with significant carotid artery stenosis were enrolled into this investigation and followed up for 5 years to explore vascular complications. All operations were performed under regional anesthesia. As premedication, all patients took 0.5 mg of alprazolam 30 minutes before the procedure. After randomization, 22 patients had awake sedation with target controlled propofol infusion, and the other 25 had only premedication. Cortisol plasma levels were serially analyzed: before surgery (T 1 ), before (T 2 ) and after release of carotid clamp (T 3 ), and at 2 (T 4 ) and 24 postoperative hours (T 5 ). Alprazolam levels were also measured before and after the surgery.
RESULTS


The plasma concentration of cortisol was significantly lower in the propofol sedation group at T 2  (P < 0.001), T 3  (P = 0.001), and T 4  (P < 0.001) than in the alprazolam-only group. Alprazolam levels did not correlate with cortisol levels at any time point. A significant positive correlation was found between the clamp time and plasma cortisol level at T 3  (P = 0.018), similarly between the degree of contralateral carotid stenosis and plasma cortisol level at T 3  (P = 0.03). Plasma cortisol concentration 2 hours after the operation (T 4 ) proved to be an independent predictor of carotid restenosis during the 5-year follow-up (odds ratio: 1.67, 95% confidence interval: 1.02-2.73, P = 0.04).
CONCLUSIONS


An additional intraoperative propofol sedation provides better stress relief than alprazolam-only premedication during awake carotid endarterectomy.",2020,"The plasma concentration of cortisol was significantly lower in the propofol sedation group at T 2  (P<0.001), T 3  (P=0.001) and T 4  (P<0.001) compared to alprazolam only group.","['22 patients had awake sedation with target controlled propofol infusion, the other 25 had only premedication', '47 consecutive patients with significant carotid artery stenosis', 'carotid endarterectomy in regional anesthesia', 'awake carotid endarterectomy']","['propofol', 'alprazolam']","['contralateral carotid stenosis and plasma cortisol level', 'cortisol levels', 'carotid restenosis', 'clamp time and plasma cortisol level', 'Plasma cortisol concentration', 'plasma concentration of cortisol', 'Alprazolam levels', 'Cortisol plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",47.0,0.0653517,"The plasma concentration of cortisol was significantly lower in the propofol sedation group at T 2  (P<0.001), T 3  (P=0.001) and T 4  (P<0.001) compared to alprazolam only group.","[{'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Szabó', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary. Electronic address: szabopeter27@gmail.com.'}, {'ForeName': 'Mátyás', 'Initials': 'M', 'LastName': 'Mayer', 'Affiliation': 'Department of Forensic Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Horváth-Szalai', 'Affiliation': 'Depatment of Laboratory Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Tóth', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Sándor', 'Initials': 'S', 'LastName': 'Márton', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Menyhei', 'Affiliation': 'Department of Vascular Surgery, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Sínay', 'Affiliation': 'Department of Vascular Surgery, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Tihamér', 'Initials': 'T', 'LastName': 'Molnár', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.06.047']
2788,31542451,Respiratory Duty Cycles in Individuals With and Without Airway Hyperresponsiveness.,"BACKGROUND


The respiratory duty cycle (T i /T tot ) can influence bronchoprovocation test results and nebulized drug delivery. The T i /T tot  has not yet been examined in individuals with airway hyperresponsiveness (AHR) in typical bronchoprovocation test conditions. This study investigated the mean T i /T tot  in participants with and without AHR and whether the T i /T tot  changes with increasing bronchoconstriction.
METHODS


Fifteen participants with AHR and fifteen participants without AHR completed this randomized crossover study. An ultrasonic spirometer was used for continuous measurement of the T i /T tot  as participants inhaled room air or aerosolized solution. Each participant completed two methacholine challenges, one using a continuous-output vibrating mesh nebulizer/ultrasonic spirometer and one with the nebulizer only. Prior to each methacholine challenge, participants inhaled room air and aerosolized saline through the nebulizer/spirometer setup to record baseline T i /T tot  data.
RESULTS


The mean T i /T tot  findings [95% CIs] during room air inhalation were 0.392 [0.378-0.406] and 0.447 [0.426-0.468] in participants with and without AHR, respectively (P < .001). The mean T i /T tot  during saline inhalation were 0.389 [0.373-0.405] and 0.424 [0.398-0.450] in participants with and without AHR (P = .040). The T i /T tot  showed a nonsignificant downward trend with progressive methacholine-induced bronchoconstriction.
CONCLUSIONS


The mean T i /T tot  in participants with AHR closely resembles the assumed T i /T tot  of 0.40 recommended for standard use when calculating methacholine challenge results. Since the T i /T tot  did not change significantly over the course of a methacholine challenge, the same T i /T tot  can be used to calculate the dose of methacholine inhaled, regardless of the level of bronchoconstriction.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03505489; URL: www.clinicaltrials.gov.",2020,"The mean T i /T tot  during saline inhalation were 0.389 +/-0.037 and 0.424 +/-0.071 in participants with and without AHR, respectively (p = 0.040).","['participants with and without AHR and whether the T i /T', 'individuals with and without airway hyperresponsiveness', 'individuals with airway hyperresponsiveness (AHR) in typical bronchoprovocation test conditions', 'Fifteen participants with AHR and fifteen participants without AHR']","['inhaled room air or aerosolized solution', 'inhaled room air and aerosolized saline']","['standard deviation during room air inhalation', 'progressive methacholine-induced bronchoconstriction', 'mean T', 'mean T i /T tot  during saline inhalation', 'mean T i /T tot  ']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449910', 'cui_str': 'Test conditions (attribute)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]",15.0,0.0750936,"The mean T i /T tot  during saline inhalation were 0.389 +/-0.037 and 0.424 +/-0.071 in participants with and without AHR, respectively (p = 0.040).","[{'ForeName': 'Christianne M', 'Initials': 'CM', 'LastName': 'Blais', 'Affiliation': 'Division of Respirology, Critical Care and Sleep Medicine, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Davis', 'Affiliation': 'Division of Respirology, Critical Care and Sleep Medicine, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Graham', 'Affiliation': 'Division of Respirology, Critical Care and Sleep Medicine, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Cockcroft', 'Affiliation': 'Division of Respirology, Critical Care and Sleep Medicine, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada. Electronic address: don.cockcroft@usask.ca.'}]",Chest,['10.1016/j.chest.2019.09.005']
2789,31601111,Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial.,"BACKGROUND


No recognized standards exist for teaching patients and their caregivers ventricular assist device (VAD) self-care skills. We compared the effectiveness of a VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training.
METHODS AND RESULTS


VAD patients and their caregivers were randomized to SBML or usual training during their implant hospitalization. The SBML group completed a pretest on 3 VAD self-care skills (controller, power source, and dressing change), then viewed videos and participated in deliberate practice on a simulator. SBML participants took a posttest and were required to meet or exceed a minimum passing standard for each of the skills. The usual training group completed the existing institutional VAD self-care teaching protocol. Before hospital discharge, the SBML and usual training groups took the same 3 VAD self-care skills tests. We compared demographic and clinical information, self-confidence, total participant training time, and skills performance between groups. Forty participants completed the study in each group. There were no differences in demographic and clinical information, self-confidence, or training time between groups. More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
CONCLUSIONS


SBML provided superior VAD self-care skills learning outcomes compared with usual training. This study has important implications for patients due to the morbidity and mortality associated with improper VAD self-care.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT03073005.",2019,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
","['Assist Device Self-Care Skills', 'Forty participants completed the study in each group', 'VAD patients and their caregivers']","['Simulation-Based Mastery Learning', 'VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training', 'SBML or usual training during their implant hospitalization', 'usual training group completed the existing institutional VAD self-care teaching protocol']","['dressing change skills', 'demographic and clinical information, self-confidence, total participant training time, and skills performance', 'demographic and clinical information, self-confidence, or training time']","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",40.0,0.0660624,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
","[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Barsuk', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Wilcox', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Harap', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Shanklin', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Gretchen P', 'Initials': 'GP', 'LastName': 'Nonog', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schulze', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Jirak', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Diane B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005794']
2790,32031096,Comparison of postoperative pain after foraminal enlargement of necrotic teeth using continuous rotary system and reciprocating instrument: A randomized clinical trial.,"Objectives


This single-blind, randomized clinical trial (RCT) aimed to compare the duration, intensity, and incidence of postoperative pain after foraminal enlargement (FE) with continuous rotary systems and reciprocating instruments.
Materials and Methods


Sixty qualified patients were randomly divided into the following two groups: the ProTaper Next group and the WaveOne group. Participants were selected from patients who had both asymptomatic necrosis and asymptomatic apical periodontitis with a single root canal. Endodontic treatment was performed in one visit, and the patients were asked to record their pain severity and analgesic consumption during a 7-day follow-up period using a visual analog scale (VAS). The data were analyzed using the Mann-Whitney U-test and Chi-square test (P < 0.05).
Results


A significant difference was observed between the two groups during the first two days of follow-up (P < 0.05). Pain experience was higher in FEs that had been created by reciprocating instruments than by continuous rotary systems. There were no significant differences in VAS pain scores over the other days (P > 0.05). None of the patients had severe postoperative pain during the follow-up period. No significant differences were observed in the prevalence of analgesic consumption between either group (P > 0.05).
Conclusions


This RCT indicates that in the 2-day follow-up period after endodontic treatment, FEs created by reciprocated instruments associated more postoperative pain than continuous rotary systems.",2020,There were no significant differences in VAS pain scores over the other days (P > 0.05).,"['Participants were selected from patients who had both asymptomatic necrosis and asymptomatic apical periodontitis with a single root canal', 'Materials and Methods\n\n\nSixty qualified patients']",['continuous rotary system and reciprocating instrument'],"['pain severity and analgesic consumption', 'severe postoperative pain', 'prevalence of analgesic consumption', 'Pain experience', 'duration, intensity, and incidence of postoperative pain', 'VAS pain scores', 'visual analog scale (VAS', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.091557,There were no significant differences in VAS pain scores over the other days (P > 0.05).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurnaz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Kutahya Health Sciences University, Kutahya, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_436_19']
2791,31899564,Counseling alone or in combination with nicotine replacement therapy for treatment of black non-daily smokers: a randomized trial.,"BACKGROUND AND AIMS


One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy.
DESIGN


Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING: Academic medical and federally qualified health centers in three US cities.
PARTICIPANTS


Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93).
INTERVENTIONS


Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups.
MEASUREMENTS


Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns.
FINDINGS


Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P < 0.0001) but non-significant changes in cotinine (P = 0.69). C + NRT reported more days abstinent (P < 0.001) and fewer total cigarettes (P = 0.002) compared with C. There was no evidence of compensation with other tobacco products.
CONCLUSIONS


Among black non-daily smokers in the United States, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT led to greater increase in days abstinent and reduction in cigarettes, with no evidence of compensation from other sources of nicotine.",2020,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[' Academic medical and federally qualified health centers in 3 US cities PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling with', 'black non-daily smokers']","['nicotine replacement therapy (NRT', 'nicotine replacement therapy', 'NRT', 'Counseling alone or in combination with nicotine replacement therapy', 'nicotine replacement therapy (C+NRT, n=185) or counseling alone (C, n=93', 'telephone smoking cessation counseling in combination with nicotine replacement therapy [NRT; C+NRT', 'nicotine gum, patch, and/or lozenge', 'counseling alone [C', 'C+NRT']","['change in nicotine and carcinogen exposure [4-(methynitrosamino) -1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns', 'NNAL', 'total cigarettes', 'biochemically-verified 30-day abstinence']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4521889', 'cui_str': 'Carcinogen (disposition)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0089147', 'cui_str': '1-Butanol'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.160448,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14948']
2792,32029509,Bortezomib with standard chemotherapy for children with acute myeloid leukemia does not improve treatment outcomes: a report from the Children's Oncology Group.,"New therapeutic strategies are needed for pediatric acute myeloid leukemia (AML) to reduce disease recurrence and treatment-related morbidity. The Children's Oncology Group Phase III AAML1031 trial tested whether the addition of bortezomib to standard chemotherapy improves survival in pediatric patients with newly diagnosed AML. AAML1031 randomized patients younger than 30 years of age with  de novo  AML to standard treatment with or without bortezomib. All patients received the identical chemotherapy backbone with either four intensive chemotherapy courses or three courses followed by allogeneic hematopoietic stem cell transplantation for high-risk patients. For those randomized to the intervention arm, bortezomib 1.3 mg/m 2  was given on days 1, 4 and 8 of each chemotherapy course. For those randomized to the control arm, bortezomib was not administered. In total, 1,097 patients were randomized to standard chemotherapy (n=542) or standard chemotherapy with bortezomib (n=555). There was no difference in remission induction rate between the bortezomib and control treatment arms (89%  vs  91%,  P =0.531). Bortezomib failed to improve 3-year event-free survival (44.8±4.5%  vs  47.0±4.5%,  P =0.236) or overall survival (63.6±4.5  vs  67.2±4.3,  P =0.356) compared with the control arm. However, bortezomib was associated with significantly more peripheral neuropathy ( P =0.006) and intensive care unit admissions ( P =0.025) during the first course. The addition of bortezomib to standard chemotherapy increased toxicity but did not improve survival. These data do not support the addition of bortezomib to standard chemotherapy in children with  de novo  AML. (Trial registered at  clinicaltrials.gov NCT01371981; https://www.cancer.gov/clinicaltrials/ NCT01371981 ).",2020,"Remission induction rate did not differ between bortezomib and control treatment arms (89% vs 91%, p=0.531).","['pediatric patients with newly diagnosed acute myeloid leukemia', '1097 patients', 'children with de novo acute myeloid leukemia', 'randomized patients younger than 30 years of age with de novo acute myeloid leukemia to standard treatment with or without', 'children with acute myeloid leukemia']","['standard chemotherapy with bortezomib', 'identical chemotherapy backbone with either four intensive chemotherapy courses or three courses followed by allogeneic hematopoietic stem cell transplantation', 'Bortezomib', 'bortezomib to standard chemotherapy', 'AAML1031', 'standard chemotherapy', 'Bortezomib with standard chemotherapy', 'bortezomib']","['three-year event-free survival', 'Remission induction rate', 'survival', 'intensive care unit admissions', 'toxicity', 'overall survival', 'peripheral neuropathy']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}]",1097.0,0.199001,"Remission induction rate did not differ between bortezomib and control treatment arms (89% vs 91%, p=0.531).","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aplenc', 'Affiliation': ""The Children's Hospital of Philadelphia, Division of Oncology, Philadelphia, PA, USA aplenc@email.chop.edu.""}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Meshinchi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Alonzo', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': ""The Children's Hospital of Philadelphia, Division of Infectious Disease, Philadelphia, PA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerbing', 'Affiliation': ""Children's Oncology Group, Monrovia, CA, USA.""}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Hirsch', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Terzah', 'Initials': 'T', 'LastName': 'Horton', 'Affiliation': ""Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kahwash', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Loken', 'Affiliation': 'Hemaologics Inc., Seattle, WA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brodersen', 'Affiliation': 'Hemaologics Inc., Seattle, WA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pollard', 'Affiliation': 'Dana Farber Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Edward Anders', 'Initials': 'EA', 'LastName': 'Kolb', 'Affiliation': 'Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Gamis', 'Affiliation': ""Children's Mercy Hospital and Clinics, Kansas City, MO, USA.""}]",Haematologica,['10.3324/haematol.2019.220962']
2793,31343446,"Efficacy, Patient-Reported Outcomes, and Safety in Male Subjects Treated With OnabotulinumtoxinA for Improvement of Moderate to Severe Horizontal Forehead Lines.","BACKGROUND


Men represent a growing segment of the facial aesthetic market.
OBJECTIVE


To evaluate investigator-assessed efficacy, patient-reported outcomes, and safety after onabotulinumtoxinA treatment of forehead lines (FHL) in men.
METHODS


Subjects with moderate to severe FHL received onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo in 6-month, double-blind periods of 2 pivotal trials. Results for men were pooled.
RESULTS


Men comprised 12% (140/1,178) of subjects. Day 30 male responder rates for achieving at least 1-grade Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150. Despite men having proportionately more severe FHL at baseline, 81.8% and 79.8% achieved Day 30 FWS ratings of none or mild at maximum eyebrow elevation and at rest, respectively (p < .05); significance versus placebo was maintained through Day 120. Men reported high satisfaction rates and improved psychological impacts. No new safety signals were detected.
CONCLUSION


Standard dosing and administration of onabotulinumtoxinA significantly improved static and dynamic FHL appearance, despite men having proportionately more severe FHL at baseline. Men reported high satisfaction and appearance-related psychological impact improvements.",2020,"Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150.","['Subjects with moderate to severe FHL received', 'Male Subjects Treated With', 'Day 30 male responder rates for achieving at least 1-grade', 'Men comprised 12% (140/1,178) of subjects', 'forehead lines (FHL) in men']","['onabotulinumtoxinA', 'placebo', 'OnabotulinumtoxinA', ""onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo""]","['Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation', 'satisfaction rates and improved psychological impacts', 'static and dynamic FHL appearance', 'severe FHL', 'responder rates']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0015420', 'cui_str': 'Eyebrows'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",30.0,0.212587,"Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150.","[{'ForeName': 'Terrence C', 'Initials': 'TC', 'LastName': 'Keaney', 'Affiliation': 'SkinDC, Arlington, Virginia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cavallini', 'Affiliation': 'Servizio di Chirurgia Plastica, Centro Diagnostico Italiano, Milan, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leys', 'Affiliation': 'Medical Skincare, Sint-Truiden, Belgium.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Drinkwater', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Manson Brown', 'Affiliation': 'Allergan Limited, Marlow, Buckinghamshire, United Kingdom.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Allergan Plc, Irvine, California.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Allergan Plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002047']
2794,32037254,Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy.,"BACKGROUND


Lipoprotein (a) [Lp(a)] has been reported to be a residual risk factor in patients who have achieved target lipid levels. The aim of the present study was to investigate the associations of Lp(a) with plaque progression and major cardiovascular events in patients with acute coronary syndromes (ACS).
METHODS


The Yokohama-ACS study included 102 patients with ACS who underwent intravascular ultrasound (IVUS) at baseline and at 10-month follow-up after percutaneous coronary intervention (PCI). The patients were randomly assigned to receive either moderate- or low-intensity statin therapy. IVUS was performed to measure the plaque volume at non-culprit lesions. We enrolled 76 patients for whom Lp(a) levels at 10-month follow-up were available.
RESULTS


The patients were divided into 2 groups according whether their Lp(a) levels were ≤20 mg/dl [low Lp(a) group; n = 49] or >20 mg/dl [high Lp(a) group; n = 27]. Baseline characteristics and low-density lipoprotein cholesterol levels at 10-month follow-up were similar in the low Lp(a) group and high Lp(a) group (87 ± 29 mg/dl vs. 93 ± 27 mg/dl, p = 0.42). The low Lp(a) group had significant plaque regression, whereas the high Lp(a) group showed slight plaque progression (-6.8% vs. 2.5%, p = 0.02). Ninety-five percent of the prognostic data were obtained 5 years after PCI. The cumulative event-free survival rate was significantly lower in the high Lp(a) group (p = 0.02; log-rank test).
CONCLUSIONS


Lp(a) levels may be an alternative predictor of further plaque regression and the likelihood of major adverse cardiovascular events in statin-treated ACS patients.",2020,The cumulative event-free survival rate was significantly lower in the high Lp(a),"['statin-treated patients with acute coronary syndrome', 'patients with acute coronary syndromes (ACS', '102 patients with ACS who underwent intravascular ultrasound (IVUS) at baseline and at 10-month follow-up after percutaneous coronary intervention (PCI', 'patients who have achieved target lipid levels', '76 patients for whom Lp(a) levels at 10-month follow-up were available']","['high Lp(a', 'serum lipoprotein (a) level', 'moderate- or low-intensity statin therapy', 'IVUS']","['slight plaque progression', 'Baseline characteristics and low-density lipoprotein cholesterol levels', 'plaque volume', 'cumulative event-free survival rate', 'coronary plaque progression and cardiovascular events']","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582826', 'cui_str': 'Serum lipoprotein measurement'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",102.0,0.0201204,The cumulative event-free survival rate was significantly lower in the high Lp(a),"[{'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan; Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: hibikiyo@yokohama-cu.ac.jp.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Komura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Maejima', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Iwahashi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kosuge', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ebina', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.01.005']
2795,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7  positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7  target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9']
2796,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
2797,32009778,"A Fixed-Dose Combination Of Gemigliptin And Rosuvastatin Exhibits Similar Pharmacokinetics, Pharmacodynamics, And Safety Compared To That Of A Loose Combination In Healthy Subjects.","Purpose


Fixed-dose combination (FDC) of gemigliptin and rosuvastatin may improve medication compliance of patients with comorbid type 2 diabetes and dyslipidemia. Pharmacokinetics (PK), pharmacodynamics (PD), and safety of gemigliptin/rosuvastatin 50/20 mg FDC was compared with a loose combination of individual tablets in healthy subjects.
Patients and methods


A randomized, open-label, single-dose, two-period, two-sequence, two-treatment crossover study was conducted. Subjects received FDC or a loose combination of gemigliptin (50 mg) and rosuvastatin (20 mg) during each period, with a 14-day washout. Serial blood samples were collected up to 72 hrs after dosing to measure plasma concentrations of gemigliptin, its active metabolite LC15-0636, and rosuvastatin for PK assessment, and DPP-4 activity for PD assessment. PK and PD parameters were calculated using a non-compartmental method. Safety profiles were evaluated throughout the study.
Results


Thirty-seven subjects completed the study. The concentration-time profiles of gemigliptin, LC15-0636, and rosuvastatin were similar between FDC and loose combination, respectively. For each of the three compounds, the geometric mean ratios (90% confidence interval) of FDC to loose combination for C max  and AUC last  fell within the bioequivalence range of 0.8-1.25. Inhibition of DPP-4 activity-time profiles after administration of FDC and loose combination was overlapping, and I max  and AUEC last  were similar. Both FDC and the loose combination were well tolerated.
Conclusion


PK, PD, and safety profiles of gemigliptin, its metabolite, and rosuvastatin were similar between FDC and loose combination. The FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) can be used as an alternative to a loose combination, which is expected to improve patient compliance.",2019,"The concentration-time profiles of gemigliptin, LC15-0636, and rosuvastatin were similar between FDC and loose combination, respectively.","['Healthy Subjects', 'healthy subjects', 'patients with comorbid type 2 diabetes and dyslipidemia', 'Results\n\n\nThirty-seven subjects completed the study']","['gemigliptin/rosuvastatin 50/20 mg FDC', 'FDC or a loose combination of gemigliptin', 'Gemigliptin And Rosuvastatin', 'rosuvastatin', 'Fixed-dose combination (FDC) of gemigliptin and rosuvastatin']","['concentration-time profiles of gemigliptin, LC15-0636, and rosuvastatin', 'Pharmacokinetics (PK), pharmacodynamics (PD), and safety', 'Pharmacokinetics, Pharmacodynamics, And Safety', 'geometric mean ratios', 'tolerated', 'Conclusion\n\n\nPK, PD, and safety profiles of gemigliptin, its metabolite, and rosuvastatin', 'medication compliance', 'Inhibition of DPP-4 activity-time profiles', 'PK and PD parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3501981'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3501981'}, {'cui': 'C3501430', 'cui_str': 'LC15-0636'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3489773', 'cui_str': 'Medication Non-Compliance'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0185078,"The concentration-time profiles of gemigliptin, LC15-0636, and rosuvastatin were similar between FDC and loose combination, respectively.","[{'ForeName': 'Eunwoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung Ryun', 'Initials': 'KR', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S197054']
2798,21135055,An aCGH classifier derived from BRCA1-mutated breast cancer and benefit of high-dose platinum-based chemotherapy in HER2-negative breast cancer patients.,"BACKGROUND


Breast cancer cells deficient for BRCA1 are hypersensitive to agents inducing DNA double-strand breaks (DSB), such as bifunctional alkylators and platinum agents. Earlier, we had developed a comparative genomic hybridisation (CGH) classifier based on BRCA1-mutated breast cancers. We hypothesised that this BRCA1-like(CGH) classifier could also detect loss of function of BRCA1 due to other causes besides mutations and, consequently, might predict sensitivity to DSB-inducing agents.
PATIENTS AND METHODS


We evaluated this classifier in stage III breast cancer patients, who had been randomly assigned between adjuvant high-dose platinum-based (HD-PB) chemotherapy, a DSB-inducing regimen, and conventional anthracycline-based chemotherapy. Additionally, we assessed BRCA1 loss through mutation or promoter methylation and immunohistochemical basal-like status in the triple-negative subgroup (TN subgroup).
RESULTS


We observed greater benefit from HD-PB chemotherapy versus conventional chemotherapy among patients with BRCA1-like(CGH) tumours [41/230 = 18%, multivariate hazard ratio (HR) = 0.12, 95% confidence interval (CI) 0.04-0.43] compared with patients with non-BRCA1-like(CGH) tumours (189/230 = 82%, HR = 0.78, 95% CI 0.50-1.20), with a significant difference (test for interaction P = 0.006). Similar results were obtained for overall survival (P interaction = 0.04) and when analyses were restricted to the TN subgroup. Sixty-three percent (20/32) of assessable BRCA1-like(CGH) tumours harboured either a BRCA1 mutation (n = 8) or BRCA1 methylation (n = 12).
CONCLUSION


BRCA1 loss as assessed by CGH analysis can identify patients with substantially improved outcome after adjuvant DSB-inducing chemotherapy when compared with standard anthracycline-based chemotherapy in our series.",2011,Similar results were obtained for overall survival (P interaction = 0.04) and when analyses were restricted to the TN subgroup.,"['HER2-negative breast cancer patients', 'Sixty-three percent (20/32) of assessable BRCA1-like(CGH) tumours harboured either a BRCA1 mutation (n = 8) or BRCA1 methylation (n = 12', 'stage III breast cancer patients, who had been randomly assigned between', 'patients with BRCA1-like(CGH']","['standard anthracycline-based chemotherapy', 'adjuvant high-dose platinum-based (HD-PB) chemotherapy, a DSB-inducing regimen, and conventional anthracycline-based chemotherapy', 'HD-PB chemotherapy versus conventional chemotherapy', 'platinum-based chemotherapy']","['BRCA1 loss through mutation or promoter methylation and immunohistochemical basal-like status', 'overall survival']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0603200', 'cui_str': 'DSB'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.105416,Similar results were obtained for overall survival (P interaction = 0.04) and when analyses were restricted to the TN subgroup.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Vollebergh', 'Affiliation': 'Division of Molecular Biology; Division of Medical Oncology.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Lips', 'Affiliation': 'Division of Experimental Therapy.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Nederlof', 'Affiliation': 'Division of Experimental Therapy; Division of Molecular Pathology.'}, {'ForeName': 'L F A', 'Initials': 'LFA', 'LastName': 'Wessels', 'Affiliation': 'Department of Bioinformatics and Statistics, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam; Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Schmidt', 'Affiliation': 'Division of Experimental Therapy; Department of Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'van Beers', 'Affiliation': 'Division of Experimental Therapy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cornelissen', 'Affiliation': 'Division of Experimental Therapy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Holtkamp', 'Affiliation': 'Division of Medical Oncology.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Froklage', 'Affiliation': 'Division of Medical Oncology.'}, {'ForeName': 'E G E', 'Initials': 'EGE', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Schrama', 'Affiliation': 'Division of Medical Oncology.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wesseling', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'van de Vijver', 'Affiliation': 'Department of Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam; Department of Pathology, Academic Medical Center.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Division of Molecular Biology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hauptmann', 'Affiliation': 'Department of Bioinformatics and Statistics, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rodenhuis', 'Affiliation': 'Division of Medical Oncology.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Division of Molecular Biology; Division of Medical Oncology. Electronic address: s.linn@nki.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq624']
2799,20643862,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.,"BACKGROUND


OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear.
PATIENTS AND METHODS


within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup.
RESULTS


Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months).
CONCLUSION


This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).",2011,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","['within OVA-301', 'relapsed ovarian cancer', 'partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial', 'patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI', '214 cases in this subgroup']","['Trabectedin plus pegylated liposomal doxorubicin', 'trabectedin plus pegylated liposomal doxorubicin (PLD']","['PFS and survival', 'median progression-free survival', 'disease progression (DP) or death', 'risk of death']","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.193055,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Area of Gynecologic Oncology, Valencian Institute of Oncology, Valencia, Spain. Electronic address: apoveda@fivo.org.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Department of Cancer Medicine, The Royal Mardsen Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq352']
2800,20643863,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.,"BACKGROUND


OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy.
PATIENTS AND METHODS


a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted.
RESULTS


similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357).
CONCLUSION


the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.",2011,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357).
","['672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months']","['Trabectedin plus pegylated liposomal doxorubicin', 'subsequent chemotherapy', 'trabectedin plus pegylated liposomal doxorubicin']","['Overall survival', 'survival benefits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",672.0,0.0927883,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357).
","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Section of Medicine, Institute of Cancer Research, The Royal Marsden Hospital, Sutton, Surrey, UK. Electronic address: stan.kaye@rmh.nhs.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Santabárbara', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Department of Medical Oncology, Valencian Institute of Oncology, Valencia, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq353']
2801,21617019,Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC).,"BACKGROUND


The objective of this multicenter, prospective uncontrolled phase II trial was to determine efficacy, safety and tolerability of vatalanib, an oral angiogenesis inhibitor targeting all known vascular endothelial growth factor receptors, in the second-line treatment of non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS


Patients with stage IIIB/IV NSCLC-proven tumor progression during or after one platinum-based chemotherapy regimen received a fixed dose of 1250 mg vatalanib either once-daily dosing (QD) or two divided daily dosing (TDD: 500 mg a.m. + 750 mg p.m.) until disease progression or unacceptable toxicity. Primary end point was the disease control rate (DCR) at 12 weeks.
RESULTS


Fifty-four and 58 patients were enrolled to the QD and TDD arms. DCR at 12 weeks was 35% in the QD and 37% in the TDD arm. The best overall response included one (2%) patient with confirmed partial response with QD and three (5%) with TDD. Median progression-free survival and overall survival were 2.1/7.3 months in the QD arm and 2.8/9.0 months with TDD arm. This therapy showed a moderate toxicity profile for the majority of patients.
CONCLUSIONS


In the chosen patient population, vatalanib QD and TDD dosing demonstrated potential benefits in tumor size reduction, DCR, and survival.",2012,Median progression-free survival and overall survival were 2.1/7.3 months in the QD arm and 2.8/9.0 months with TDD arm.,"['relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC', 'non-small-cell lung cancer (NSCLC', 'Patients with stage IIIB/IV NSCLC-proven tumor progression during or after one platinum-based chemotherapy regimen received a', 'Fifty-four and 58 patients were enrolled to the QD and TDD arms']","['PTK787/ZK 222584 (vatalanib', 'fixed dose of 1250 mg vatalanib either once-daily dosing (QD']","['efficacy, safety and tolerability', 'Median progression-free survival and overall survival', 'DCR, and survival', 'DCR', 'moderate toxicity profile', 'disease control rate (DCR']","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0912413', 'cui_str': 'PTK 787'}, {'cui': 'C1524078', 'cui_str': 'ZK222584'}, {'cui': 'C0912586', 'cui_str': 'vatalanib'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0747163,Median progression-free survival and overall survival were 2.1/7.3 months in the QD arm and 2.8/9.0 months with TDD arm.,"[{'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Gauler', 'Affiliation': 'Department of Medicine (Cancer Research), West German Tumor Center, University Hospital of University Duisburg-Essen, Essen, Germany. Electronic address: Thomas.gauler@uk-essen.de.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mauguen', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Meric', 'Affiliation': 'Hopital La Pitié-Salpetriere, Paris.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gounant', 'Affiliation': 'Hopital Tenon, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fischer', 'Affiliation': 'University Medical Center of the Johannes Gutenberg University Mainz, Mainz.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Overbeck', 'Affiliation': 'University Hospital Goettingen, Goettingen.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Krissel', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Berlin, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Bayer Oy, Espoo, Finland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Commo', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'W E E', 'Initials': 'WEE', 'LastName': 'Eberhardt', 'Affiliation': 'Department of Medicine (Cancer Research), West German Tumor Center, University Hospital of University Duisburg-Essen, Essen, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr255']
2802,21633047,Randomized phase II non-inferiority study (NO16853) of two different doses of capecitabine in combination with docetaxel for locally advanced/metastatic breast cancer.,"BACKGROUND


This phase II study investigated whether a lower-than-approved dose of capecitabine, plus docetaxel (XT), would improve tolerability versus standard-dose XT without compromising efficacy.
PATIENTS AND METHODS


Women aged ≥18 years with locally advanced/metastatic breast cancer resistant to anthracycline-based chemotherapy in the (neo)adjuvant, first- or second-line metastatic setting were eligible. Patients were randomly assigned to receive standard-dose XT (capecitabine 1250 mg/m(2) twice daily, days 1-14; docetaxel 75 mg/m(2), day 1 every 3 weeks) or low-dose XT (capecitabine 825 mg/m(2) twice daily, days 1-14; docetaxel as above). The primary objective was to demonstrate non-inferiority of low-dose to standard-dose XT in terms of progression-free survival (PFS).
RESULTS


470 patients were randomly allocated in a 1 : 1 ratio to standard-dose or low-dose XT. Median PFS was 7.9 versus 5.8 months [hazard ratio 1.16, 95% confidence interval (CI) 0.95-1.43] in the standard-dose and low-dose arms, respectively. The upper limit of the 95% CI was above the predefined non-inferiority margin (1.35, P = 0.078). Secondary efficacy end points were consistent with PFS. The frequency and severity of adverse events was similar in both treatment arms.
CONCLUSIONS


Non-inferiority of low-dose to standard-dose XT in terms of PFS was not demonstrated; this may be due to regional subgroup effects.",2012,"Median PFS was 7.9 versus 5.8 months [hazard ratio 1.16, 95% confidence interval (CI) 0.95-1.43] in the standard-dose and low-dose arms, respectively.","['470 patients', 'Women aged ≥18 years with locally advanced/metastatic breast cancer resistant to anthracycline-based chemotherapy in the (neo)adjuvant, first- or second-line metastatic setting were eligible', 'locally advanced/metastatic breast cancer']","['capecitabine', 'capecitabine, plus docetaxel (XT', 'XT (capecitabine', 'docetaxel', '1\u2009:\u20091 ratio to standard-dose or low-dose XT', 'standard-dose XT (capecitabine 1250 mg/m(2']","['Median PFS', 'progression-free survival (PFS', 'frequency and severity of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",470.0,0.230211,"Median PFS was 7.9 versus 5.8 months [hazard ratio 1.16, 95% confidence interval (CI) 0.95-1.43] in the standard-dose and low-dose arms, respectively.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Buzdar', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: abuzdar@mdanderson.org.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Digumarti', 'Affiliation': ""Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad, India.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Goedhals', 'Affiliation': 'Department of Oncotherapy, National Hospital, Bloemfontein, South Africa.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Cancer Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Semiglazov', 'Affiliation': 'Breast Cancer Department, NN Petrov Research Institute of Oncology, St Petersburg, Russia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cheporov', 'Affiliation': 'Department of Oncology, Regional Clinical Oncology Hospital, Yaroslavl, Russia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gotovkin', 'Affiliation': 'Department of Oncology, Regional Oncology Dispensary, Ivanovo, Russia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hoersch', 'Affiliation': 'Department of Statistics, Dr Manfred Köhler GmbH, Freiburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rittweger', 'Affiliation': 'Product Development Oncology Department, Hoffmann-La Roche Inc, Nutley, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Miles', 'Affiliation': 'Department of Medical Oncology, East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre, Middlesex, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Blokhin Cancer Research Center, Moscow, Russia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr256']
2803,21212155,Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study.,"BACKGROUND


Sorafenib is a small-molecule multitargeted kinase inhibitor that blocks the activation of C-RAF, B-RAF, c-KIT, FLT-3, RET, vascular endothelial growth factor receptor 2 (VEGFR-2), VEGFR-3 and platelet-derived growth factor receptor β. The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC).
METHODS


The trial was designed to select the most promising sorafenib-containing combination in previously untreated elderly (≥70 years) stage IIIB or IV NSCLC patients, with performance status of zero to two. Patients were randomly assigned to one of the following combinations: gemcitabine, 1200 mg/m(2) days 1 and 8, every 21 days, for a maximum of six cycles, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 1); or erlotinib, 150 mg/day, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 2). A selection design was applied with 1-year survival rate as the primary end point of the study, requiring 58 patients.
RESULTS


Sixty patients were randomly allocated to the study (31 patients in arm 1 and 29 patients in arm 2). After a median follow-up of 15 months, 10 patients [32%, 95% confidence interval (CI) 16% to 49%] in arm 1 and 13 patients (45%, 95% CI 27% to 63%) in arm 2 were alive at 1 year. Median overall survival was 6.6 and 12.6 months in arm 1 and arm 2, respectively. Observed toxic effects were consistent with the expected drug profiles.
CONCLUSIONS


The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm. According to the selection design, this combination warrants further investigation in phase III trials.",2011,The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm.,"['unselected untreated elderly patients with non-small-cell lung cancer (NSCLC', 'elderly patients with advanced non-small-cell lung cancer', 'Sixty patients were randomly allocated to the study (31 patients in arm 1 and 29 patients in arm 2', 'in previously untreated elderly (≥70 years) stage IIIB or IV NSCLC patients, with performance status of zero to two', 'elderly patients with advanced NSCLC']","['erlotinib and sorafenib', 'gemcitabine', 'erlotinib or with gemcitabine', 'erlotinib, 150 mg/day, plus sorafenib', 'sorafenib-containing combination', 'sorafenib', 'erlotinib or gemcitabine', 'Sorafenib']","['clinical activity and safety', 'toxic effects', '1-year survival rate', 'Median overall survival']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",60.0,0.110558,The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'Division of Medical Oncology, S.G. Moscati Hospital, Avellino.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morgillo', 'Affiliation': 'Division of Medical Oncology, Department of Clinical and Experimental Medicine and Surgery ""F. Magrassi e A. Lanzara"", Second University of Naples, Naples.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Favaretto', 'Affiliation': 'Division of Medical Oncology II, Istituto Oncologico Veneto, Padua.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic-Oncology Unit 1st, Lung Diseases Department, San Camillo Hospital, Rome.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'Pulmonary Unit, University Hospital of Pisa, Pisa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cerea', 'Affiliation': ""The Falck Division of Medical Oncology, Ospedale Niguarda Ca' Granda, Milan.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mattioli', 'Affiliation': 'Medical Oncology Unit, S. Croce Hospital, Fano.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Medical Oncology Unit, Department of Molecular and Clinical Endocrinology, University of Naples ""Federico II"".'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Division of Medical Oncology, S.G. Moscati Hospital, Avellino.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fasano', 'Affiliation': 'Division of Medical Oncology, Department of Clinical and Experimental Medicine and Surgery ""F. Magrassi e A. Lanzara"", Second University of Naples, Naples.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pasello', 'Affiliation': 'Division of Medical Oncology II, Istituto Oncologico Veneto, Padua.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ricciardi', 'Affiliation': 'Thoracic-Oncology Unit 1st, Lung Diseases Department, San Camillo Hospital, Rome.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maione', 'Affiliation': 'Division of Medical Oncology, S.G. Moscati Hospital, Avellino.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Clinical Trials Unit, National Cancer Institute, Naples, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Division of Medical Oncology, Department of Clinical and Experimental Medicine and Surgery ""F. Magrassi e A. Lanzara"", Second University of Naples, Naples. Electronic address: fortunato.ciardiello@unina2.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq630']
2804,21228335,Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study.,"BACKGROUND


The randomized phase II OPUS (Oxaliplatin and Cetuximab in First-Line Treatment of Metastatic Colorectal Cancer) study showed that tumor KRAS mutation status was predictive for outcome in patients receiving cetuximab plus FOLFOX-4 (oxaliplatin/5-fluorouracil/folinic acid) as first-line therapy for metastatic colorectal cancer (mCRC).
PATIENTS AND METHODS


The biomarker analysis was extended through the use of additional DNA samples extracted from stained tissue sections. KRAS and BRAF tumor mutation status was determined for new (and for BRAF, existing) samples using a PCR technique. Clinical outcome was reassessed according to mutation status. Overall survival data are presented.
RESULTS


Of 315 KRAS evaluable patient samples (93%), 179 tumors (57%) were KRAS wild type. Eleven of 309 (4%) KRAS/BRAF evaluable tumors (all KRAS wild type) carried BRAF mutations. The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in patients with KRAS wild-type tumors. A favorable effect on survival was also observed.
CONCLUSIONS


These results confirm the efficacy of cetuximab plus FOLFOX-4 in the first-line treatment of patients with KRAS wild-type mCRC and confirm KRAS mutation status as an effective predictive biomarker. The small number of tumors with BRAF mutations precluded the drawing of definitive conclusions concerning the predictive or prognostic utility of this biomarker.",2011,"The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in patients with KRAS wild-type tumors.","['metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer', 'metastatic colorectal cancer']","['cetuximab plus FOLFOX-4 (oxaliplatin/5-fluorouracil/folinic acid', 'cetuximab plus FOLFOX-4', 'OPUS (Oxaliplatin and Cetuximab']","['progression-free survival', 'KRAS and BRAF tumor mutation status', 'survival', 'Overall survival data']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0273497,"The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in patients with KRAS wild-type tumors.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology, BMT with Section Pneumology, University Hospital, Hamburg-Eppendorf, Germany. Electronic address: c.bokemeyer@uke.uni-hamburg.de.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'City Clinical Hospital #4, Dnepropetrovsk State Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Hartmann', 'Affiliation': 'Department of Medical Oncology, Hematology, Immunology, Rheumatology, and Pulmonology, South West German Comprehensive Cancer, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Division of Clinical Pharmacology and New Drugs, Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schuch', 'Affiliation': 'Department of Oncology, Hematology, BMT with Section Pneumology, University Hospital, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zubel', 'Affiliation': 'Global Clinical Development Unit-Oncology.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Celik', 'Affiliation': 'Global Clinical Development Unit-Oncology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schlichting', 'Affiliation': 'Global Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koralewski', 'Affiliation': 'Oncology, Rydygier Memorial Hospital, Krakow-Nowa Huta, Poland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq632']
2805,21859900,"Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: an Italian, multicenter, randomized phase III trial.","BACKGROUND


The purpose of the study was to evaluate the benefit of adjuvant chemotherapy (AC) versus surgery alone in patients with muscle-invasive bladder cancer (MIBC).
PATIENTS AND METHODS


One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma were randomly allocated to control (92 patients) or to four courses of AC (102 patients). These latter patients were further randomly assigned to receive gemcitabine 1000 mg/m(2) days 1, 8 and 15 and cisplatin 70 mg/m(2) day 2 or gemcitabine as above plus cisplatin 70 mg/m(2) day 15, every 28 days.
RESULTS


At a median follow-up of 35 months, the 5-year overall survival (OS) was 48.5%, with no difference between the two arms [P = 0.24, hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.84-1.99]. Mortality hazard was significantly correlated with Nodes (N) and Tumor (T) stage. The control and AC arms had comparable disease-free survival (42.3% and 37.2%, respectively; P = 0.70, HR 1.08, 95% CI 0.73-1.59). Only 62% of patients received the planned cycles. A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006). A similar global quality of life was observed in the two arms.
CONCLUSION


The study was underpowered to demonstrate that AC with cisplatin and gemcitabine improves OS and disease-free survival in patients with MIBC.",2012,A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006).,"['patients with muscle-invasive bladder cancer submitted to', 'One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma', 'patients with muscle-invasive bladder cancer (MIBC', 'patients with MIBC']","['radical cystectomy', 'AC with cisplatin and gemcitabine', 'cisplatin', 'gemcitabine 1000 mg/m(2) days 1, 8 and 15 and cisplatin 70 mg/m(2) day 2 or gemcitabine as above plus cisplatin', 'Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy', 'adjuvant chemotherapy (AC) versus surgery alone']","['Mortality hazard', '5-year overall survival (OS', 'incidence of thrombocytopenia', 'OS and disease-free survival', 'disease-free survival', 'global quality of life', 'hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0225340', 'cui_str': 'Transitional Epithelial Cells'}, {'cui': 'C0699885', 'cui_str': 'Carcinoma of bladder (disorder)'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",194.0,0.208367,A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Department of Medical Oncology, Regina Elena Cancer Institute, Rome. Electronic address: cognetti@ifo.it.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Ruggeri', 'Affiliation': 'Division of Medical Oncology, Belcolle Hospital, Viterbo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Felici', 'Affiliation': 'Department of Medical Oncology, Regina Elena Cancer Institute, Rome.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gallucci', 'Affiliation': 'Department of Urology, Regina Elena Cancer Institute, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Muto', 'Affiliation': 'Department of Urology, San Giovanni Bosco Hospital, Torino.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pollera', 'Affiliation': 'Division of Medical Oncology, Belcolle Hospital, Viterbo.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': 'Department of Medical Oncology, Policlinico Universitario, Cagliari.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rubagotti', 'Affiliation': 'Departments of Medical Oncology and of Oncology, Biology and Genetics (Biostatistics Unit), National Cancer Research Institute and University, Genova; Departments of Medical Oncology and of Oncology, Biology and Genetics, National Cancer Research Institute and University, Genova.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Giannarelli', 'Affiliation': 'Department of Biostatistics, Regina Elena Cancer Institute, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Departments of Medical Oncology and of Oncology, Biology and Genetics, National Cancer Research Institute and University, Genova.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr354']
2806,23592701,Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small-cell lung cancer.,"BACKGROUND


We compared late thoracic radiotherapy (TRT) with early TRT in the treatment of limited-disease small-cell lung cancer (LD-SCLC).
PATIENTS AND METHODS


Patients with LD-SCLC received four cycles of etoposide plus cisplatin every 21 days. Patients were randomly assigned to receive either TRT administered concurrently with the first cycle (early TRT) or the third cycle (late TRT) of chemotherapy. The primary end point was complete response rate.
RESULTS


Two hundred twenty-two patients were randomly assigned.Late TRT was not inferior to early TRT in terms of the complete response rate (early v late; 36.0% v 38.0%). Other efficacy measures including overall survival [median, 24.1 v 26.8 months;hazard ratio (HR) 0.93; 95% CI = 0.67–1.29] and progression free survival (median, 12.4 v 11.2 months; HR 1.09; 95%CI = 0.80–1.48) were not different between two arms. No statistical difference was noted in the pattern of treatment failures.However, neutropenic fever occurred more commonly in the early TRT arm than the late TRT arm (21.6% v 10.2%; P = 0.02) [corrected].
CONCLUSION


In LD-SCLC treatment, TRT starting in the third cycle of chemotherapy seemed to be noninferior to early TRT, and had a more favorable profile with regard to neutropenic fever.",2013,Late TRT was not inferior to early TRT in terms of the complete response rate (early v late; 36.0% v 38.0%).,"['Two hundred twenty-two patients were randomly assigned', 'limited-disease small-cell lung cancer', 'Patients with LD-SCLC']","['TRT administered concurrently with the first cycle (early TRT) or the third cycle (late TRT) of chemotherapy', 'late thoracic radiotherapy (TRT) with early TRT', 'etoposide plus cisplatin', 'concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy']","['progression free survival', 'neutropenic fever', 'complete response rate', 'overall survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",222.0,0.191795,Late TRT was not inferior to early TRT in terms of the complete response rate (early v late; 36.0% v 38.0%).,"[{'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pyo', 'Affiliation': ''}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Sohn', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Suh', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'S-W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt140']
2807,21282282,Differential efficacy of three cycles of CMF followed by tamoxifen in patients with ER-positive and ER-negative tumors: long-term follow up on IBCSG Trial IX.,"BACKGROUND


The benefit of adjuvant chemotherapy in postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer is being reassessed.
PATIENTS AND METHODS


After stratification by ER status, 1669 postmenopausal patients with operable lymph node-negative breast cancer were randomly assigned to three 28-day courses of 'classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone for 5 years.
RESULTS


ERs were positive in 81% of tumors. At a median follow-up of 13.1 years, patients with ER-positive breast cancers did not benefit from CMF [13-year disease-free survival (DFS) 64% CMF→tamoxifen, 66% tamoxifen; P = 0.99], whereas CMF substantially improved the prognosis of patients with ER-negative breast cancer (13-year DFS 73% versus 57%, P = 0.001). Similarly, breast cancer-free interval (BCFI) was identical in the ER-positive cohort but significantly improved by chemotherapy in the ER-negative cohort (13-year BCFI 80% versus 63%, P = 0.001). CMF had no influence on second nonbreast malignancies or deaths from other causes.
CONCLUSION


CMF is not beneficial in postmenopausal patients with node-negative ER-positive breast cancer but is highly effective within the ER-negative cohort. In the future, other markers of chemotherapy response may define a subset of patients with ER-positive tumors who may benefit from adjuvant chemotherapy.",2011,"(13-year DFS 73% versus 57%, P = 0.001).","['patients with ER-negative breast cancer', 'postmenopausal patients with node-negative ER-positive breast cancer', 'patients with ER-positive tumors who may benefit from adjuvant chemotherapy', '1669 postmenopausal patients with operable lymph node-negative breast cancer', 'patients with ER-positive and ER-negative tumors', 'postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer']","['CMF', 'adjuvant chemotherapy', ""classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone"", 'tamoxifen']","['breast cancer-free interval (BCFI', 'CMF [13-year disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}]","[{'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1669.0,0.107085,"(13-year DFS 73% versus 57%, P = 0.001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aebi', 'Affiliation': 'Division of Medical Oncology, Berne University Hospital and Swiss Group for Clinical Cancer research (SAKK), Berne, Switzerland. Electronic address: stefan.aebi@onkologie.ch.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Braun', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'Medical Onco-Gynecology Unit, Department of Medicine, Geneva University Hospital, Geneva.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Center and Inselspital, Berne, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Harvard Medical School, Boston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': 'Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindtner', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Ljulbljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': ""Department of Medical Oncology, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': 'Department of Medical Oncology, Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': 'IBCSG Pathology Review Office, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'IBCSG Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group, Berne, Switzerland; School of Public Health, University of Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Department of Medicine, European Institute of Oncology, Milan, Italy; Department of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq754']
2808,21652583,"High-dose chemotherapy consolidation for chemosensitive advanced soft tissue sarcoma patients: an open-label, randomized controlled trial.","BACKGROUND


Metastatic soft tissue sarcoma (STS) prognosis remains poor and few cytotoxic agents offer proven efficacy. This randomized open phase III study examines whether high-dose (HD) chemotherapy with peripheral blood stem cells (PBSCs) could improve overall survival (OS) of chemosensitive patients.
PATIENTS AND METHODS


Advanced STS patients aged 18-65 years received four courses of standard mesna, adryamycin, ifosfamide and dacarbazine (MAID) treatment. Chemotherapy-responding patients and patients with at least stable disease amenable to complete surgical resection were randomized to receive standard dose (SD) with two successive MAID cycles or HD treatments of one MAID then MICE intensification: mesna (3.6 g/m(2), day 1-5), ifosfamide (2.5 g/m(2), day 1-4), carboplatin [area under the curve (AUC) 5/day 2-4] and etoposide (300 mg/m(2), day 1-4) with PBSC reinjection at day 7.
RESULTS


From 2000 to 2008, 207 patients received four cycles of MAID and 87 assessable patients were randomly assigned to receive the following: 46 SD, 41 HD, with 45 and 38 maintained for analyses after secondary centralized histological review. Futility analyses led to study closure in November 2008. Three-year OS was 49.4% for the SD group versus 32.7% for HD arm, hazard ratio= 1.26, 95% confidence interval 0.70-2.29; progression-free survival was 32.4% and 14.0%, respectively. HD treatment led to higher grades 3-4 toxicity.
CONCLUSION


This study failed to show an OS advantage for advanced STS patients treated with dose-intensified chemotherapy with PBSC.",2012,"Three-year OS was 49.4% for the SD group versus 32.7% for HD arm, hazard ratio= 1.26, 95% confidence interval 0.70-2.29; progression-free survival was 32.4% and 14.0%, respectively.","['chemosensitive patients', 'patients and patients with at least stable disease amenable to complete surgical resection', 'Advanced STS patients aged 18-65 years', 'advanced STS patients treated with dose-intensified chemotherapy with PBSC', 'chemosensitive advanced soft tissue sarcoma patients', 'From 2000 to 2008, 207 patients received four cycles of MAID and 87 assessable patients', 'Metastatic soft tissue sarcoma ']","['mesna', 'high-dose (HD) chemotherapy with peripheral blood stem cells (PBSCs', 'standard mesna, adryamycin, ifosfamide and dacarbazine (MAID) treatment', 'etoposide', 'ifosfamide', 'High-dose chemotherapy consolidation', 'Chemotherapy-responding', 'carboplatin [area under the curve ']","['progression-free survival', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0079864', 'cui_str': 'Murine Acquired Immune Deficiency Syndrome'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.328381,"Three-year OS was 49.4% for the SD group versus 32.7% for HD arm, hazard ratio= 1.26, 95% confidence interval 0.70-2.29; progression-free survival was 32.4% and 14.0%, respectively.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bui-Nguyen', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux. Electronic address: bui@bergonie.org.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Center Léon Bérard, Lyon.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Institut Claudius Regaud, Toulouse.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Center Oscar Lambret, Lille.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Bay', 'Affiliation': 'Center Jean Perrin, Center Hospitalier Universitaire Estaing, Clermont-Ferrand.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Coindre', 'Affiliation': 'Department of Pathology and INSERM U916, Institut Bergonié, Bordeaux.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': ""Center Val d'Aurelle-Paul Lamarque, Montpellier.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonichon', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié and Inserm CIC-EC 7, Bordeaux.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lotz', 'Affiliation': 'Hôpital Tenon, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thyss', 'Affiliation': 'Center Antoine-Lacassagne, Nice.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'French National Federation for Comprehensive Cancer Centers, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathoulin-Pélissier', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié and Inserm CIC-EC 7, Bordeaux.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Center Léon Bérard, Lyon.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr282']
2809,21252061,"Quality of life, geriatric assessment and survival in elderly patients with non-small-cell lung cancer treated with carboplatin-gemcitabine or carboplatin-paclitaxel: NVALT-3 a phase III study.","BACKGROUND


Elderly patients with advanced non-small-cell lung cancer (NSCLC) may derive similar benefit from platinum-based chemotherapy as younger patients. Quality of life (QoL) and comprehensive geriatric assessment (CGA) is often advocated to assess benefits and risks.
PATIENTS AND METHODS


A total of 181 chemotherapy-naive patients [≥70 years, performance score (PS) of 0-2] with stage III-IV NSCLC received carboplatin and gemcitabine (CG) (n = 90) or carboplatin and paclitaxel (CP) (n = 91) every 3 weeks for up to four cycles. Primary end point was change in global QoL from baseline compared with week 18. Pretreatment CGA and mini geriatric assessment during and after treatment were undertaken. A principal component (PC) analysis was carried out to determine the underlying dimensions of CGA and QoL and subsequently related to survival.
RESULTS


There were no changes in QoL after treatment. The number of QoL responders (CG arm, 12%; CP arm, 5%) was not significantly different. CGA items were only associated with neuropsychiatric toxicity. Quality-adjusted survival was not different between treatment arms. The PC analysis derived from nine CGA, six QoL and one PS score indicated only one dominant dimension. This dimension was strongly prognostic, and physical and role functioning, Groningen Frailty Indicator and Geriatric Depression Scale were its largest contributors.
CONCLUSIONS


Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner. CGA and QoL items measure one underlying dimension, which is highly prognostic.",2011,"CONCLUSIONS


Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner.","['Elderly patients with advanced non-small-cell lung cancer (NSCLC', '181 chemotherapy-naive patients [≥70 years, performance score (PS) of 0-2] with', 'elderly patients with non-small-cell lung cancer treated with']","['carboplatin-gemcitabine or carboplatin-paclitaxel', 'carboplatin and paclitaxel (CP', 'carboplatin and gemcitabine (CG', 'Paclitaxel or gemcitabine', 'platinum-based chemotherapy', 'carboplatin']","['Quality of life (QoL) and comprehensive geriatric assessment (CGA', 'number of QoL responders', 'Quality-adjusted survival', 'neuropsychiatric toxicity', 'global QoL', 'strongly prognostic, and physical and role functioning, Groningen Frailty Indicator and Geriatric Depression Scale', 'Quality of life, geriatric assessment and survival', 'QoL']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C4075876', 'cui_str': 'Groningen Frailty Indicator'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]",181.0,0.0447238,"CONCLUSIONS


Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Biesma', 'Affiliation': ""Department of Pulmonology, Jeroen Bosch Hospital, 's-Hertogenbosch.""}, {'ForeName': 'A N M', 'Initials': 'ANM', 'LastName': 'Wymenga', 'Affiliation': 'Department of Internal Medicine, Medisch Spectrum Twente, Enschede.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Biometrics Department, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dalesio', 'Affiliation': 'Biometrics Department, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'H J M', 'Initials': 'HJM', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonology, Alysis Zorggroep, Location Rijnstate Hospital, Arnhem.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stigt', 'Affiliation': 'Department of Pulmonology, Isala Clinics, Zwolle.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'van Felius', 'Affiliation': 'Department of Pulmonology, Twenteborg Hospital, Almelo.'}, {'ForeName': 'J W G', 'Initials': 'JWG', 'LastName': 'van Putten', 'Affiliation': 'Department of Pulmonology, Martini Hospital.'}, {'ForeName': 'J P J', 'Initials': 'JPJ', 'LastName': 'Slaets', 'Affiliation': 'Department of Internal Medicine.'}, {'ForeName': 'H J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'Department of Pulmonology, University Medical Center, Groningen, The Netherlands. Electronic address: h.j.m.groen@long.umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq637']
2810,21734221,Trabectedin plus pegylated liposomal doxorubicin in the treatment of patients with partially platinum-sensitive ovarian cancer: current evidence and future perspectives.,"The effectiveness of platinum re-treatment in relapsed ovarian cancer depends on relapse-free/treatment-free intervals. Platinum agents can be effectively readministered to platinum-sensitive patients (relapsing >12 months after platinum), but efficacy is lower in partially platinum-sensitive (PPS) disease (relapsing 6-12 months after platinum). There is no clear standard treatment challenging PPS patients. Survival data in this subset with chemotherapy combinations such as pegylated liposomal doxorubicin (PLD) plus carboplatin or gemcitabine plus PLD are available from phase II trials ranging from 16 to 21 months. Recent results from OVA-301 phase III randomized trial evaluating trabectedin plus PLD showed the longest median overall survival ever reported in PPS patients (23 months). Subsequent chemotherapy (including platinum-based regimens) was administered later and survival in patients receiving third-line platinum was longer in patients treated with trabectedin plus PLD compared with those treated with PLD alone. These results suggest that prolonging platinum-free interval (PFI) with an effective non-platinum regimen improves outcome with subsequent third-line platinum treatment. An ongoing phase III trial (INOVATYON) aims to demonstrate if the results observed with trabectedin plus PLD in PPS patients are due to PFI extension, and if PFI extension with non-platinum combination prolongs response to subsequent platinum and survival in this population.",2012,Subsequent chemotherapy (including platinum-based regimens) was administered later and survival in patients receiving third-line platinum was longer in patients treated with trabectedin plus PLD compared with those treated with PLD alone.,"['relapsed ovarian cancer', 'patients with partially platinum-sensitive ovarian cancer']","['Trabectedin plus pegylated liposomal doxorubicin', 'Platinum agents', 'platinum re-treatment', 'Subsequent chemotherapy (including platinum-based regimens', 'trabectedin plus PLD', 'pegylated liposomal doxorubicin (PLD) plus carboplatin or gemcitabine plus PLD']","['prolonging platinum-free interval (PFI', 'longest median overall survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0359809,Subsequent chemotherapy (including platinum-based regimens) was administered later and survival in patients receiving third-line platinum was longer in patients treated with trabectedin plus PLD compared with those treated with PLD alone.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Obstetrics and Gynecology, Charité University Hospital, Berlin, Germany. Electronic address: sehouli@aol.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Clinical R&D, PharmaMar, Colmenar Viejo, Madrid.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Department of Medical Oncology, Centro Oncológico MD Anderson International, Madrid, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr321']
2811,32022890,An Open Trial of a Mind-Body Intervention for Young Women with Moderate to Severe Primary Dysmenorrhea.,"OBJECTIVE


To evaluate the feasibility, acceptability, and preliminary efficacy of a mind-body intervention for moderate to severe primary dysmenorrhea (PD).
DESIGN


Open trial (single arm).
SETTING


Academic medical school.
SUBJECTS


A total of 20 young adult women with moderate to severe primary dysmenorrhea were included across four separate intervention groups.
METHODS


All participants received five 90-minute sessions of a mind-body intervention and completed self-report measures of menstrual pain, depression, anxiety, somatization, and pain catastrophizing at baseline, post-treatment, and at one-, two-, three-, and 12-month follow-up. Self-report of medication use and use of skills learned during the intervention were also collected at all follow-up points.
RESULTS


Participants reported significantly lower menstrual pain over time compared with baseline. No changes in anxiety, depression, or somatization were observed, although pain catastrophizing improved over time. Changes in menstrual pain were not associated with changes in medication use or reported use of skills.
CONCLUSIONS


A mind-body intervention is a promising nondrug intervention for primary dysmenorrhea, and future research should focus on testing the intervention further as part of a randomized clinical trial.",2020,"A total of 20 young adult women with moderate to severe primary dysmenorrhea were included across four separate intervention groups.
","['20 young adult women with moderate to severe primary dysmenorrhea', 'Academic medical school', 'Young Women with Moderate to Severe Primary Dysmenorrhea', 'moderate to severe primary dysmenorrhea (PD']","['mind-body intervention', 'Mind-Body Intervention']","['menstrual pain', 'pain catastrophizing', 'menstrual pain, depression, anxiety, somatization, and pain catastrophizing', 'anxiety, depression, or somatization']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]",[],"[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",20.0,0.0288666,"A total of 20 young adult women with moderate to severe primary dysmenorrhea were included across four separate intervention groups.
","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Payne', 'Affiliation': 'McLean Hospital/Harvard Medical School, Belmont, Massachusetts.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Seidman', 'Affiliation': 'McLean Hospital/Harvard Medical School, Belmont, Massachusetts.'}, {'ForeName': 'Tamineh', 'Initials': 'T', 'LastName': 'Romero', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Myung-Shin', 'Initials': 'MS', 'LastName': 'Sim', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz378']
2812,31836203,Corneal epithelial thickness and corneal curvature changes during the day: The effects of daily disposable contact lens wear.,"PURPOSE


To evaluate the changes in corneal epithelial thickness and corneal anterior and posterior curvatures during the day, and the effect of wearing daily disposable soft contact lenses.
METHODS


Thirty-two healthy volunteers were enrolled in a randomized crossover study. At the baseline visit, corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany) were performed in the morning and in the afternoon (8 hours after). Then, each subject was fitted with the following brands of daily disposable contact lenses in random order: Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue Oneday (Nesofilcon A) on different days. All fitted lenses had a power of -3.00 diopters (D). Measurements were repeated before putting the contact lens on and after an-eight-hour contact lens wear.
RESULTS


With no lens wear, the anterior topographic indices showed significant steepening [Kflat: p < 0.0001; Ksteep: p < 0.0001 and maximum keratometry value (Kmax): p = 0.04] and the corneal thickness significantly decreased in the central and temporal portion of the cornea in the afternoon. There were no significant changes in the posterior topographical indices and corneal epithelial thickness. With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05). There was no statistically significant difference in the epithelial thickness among the groups wearing different contact lens types (p > 0.05).
CONCLUSIONS


Anterior corneal topographic indices steepen depending on the natural diurnal variations. Daily wear of soft contact lenses appears to mask this steepening. The corneal epithelial thickness is not affected by daily disposable soft contact lenses.",2020,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).",['Thirty-two healthy volunteers'],"['daily disposable contact lens wear', 'soft contact lenses']","['Corneal epithelial thickness and corneal curvature changes', 'Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue', 'corneal thickness', 'epithelial thickness', 'corneal epithelial thickness and corneal anterior and posterior curvatures', 'corneal epithelial thickness', 'corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany', 'posterior topographical indices and corneal epithelial thickness', 'corneal and epithelial thickness, and the anterior and posterior curvatures']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",32.0,0.0226964,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).","[{'ForeName': 'Semra Akkaya', 'Initials': 'SA', 'LastName': 'Turhan', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: semraakkaya85@hotmail.com.'}, {'ForeName': 'Didem Dizdar', 'Initials': 'DD', 'LastName': 'Yigit', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: drdidemdizdar@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Toker', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: dretoker@gmail.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.11.017']
2813,32017598,Velocity-based resistance training: impact of velocity loss in the set on neuromuscular performance and hormonal response.,"This study aimed to compare the effects of 2 resistance training (RT) programs with different velocity losses (VLs) allowed in each set: 10% (VL10%) versus 30% (VL30%) on neuromuscular performance and hormonal response. Twenty-five young healthy males were randomly assigned into 2 groups: VL10% ( n  = 12) or VL30% ( n  = 13). Subjects followed a velocity-based RT program for 8 weeks (2 sessions per week) using only the full-squat (SQ) exercise at 70%-85% 1-repetition maximum (1RM). Repetition velocity was recorded in all training sessions. A 20-m running sprint, countermovement jump (CMJ), 1RM, muscle endurance, and electromyogram (EMG) during SQ exercise and resting hormonal concentrations were assessed before and after the RT program. Both groups showed similar improvements in muscle strength and endurance variables (VL10%: 7.0%-74.8%; VL30%: 4.2%-73.2%). The VL10% resulted in greater percentage increments in CMJ (9.2% vs. 5.4%) and sprint performance (-1.5% vs. 0.4%) than VL30%, despite VL10% performing less than half of the repetitions than VL30% during RT. In addition, only VL10% showed slight increments in EMG variables, whereas no significant changes in resting hormonal concentrations were observed. Therefore, our results suggest that velocity losses in the set as low as 10% are enough to achieve significant improvements in neuromuscular performance, which means greater efficiency during RT.  Novelty  The VL10% group showed similar or even greater percentage of changes in physical performance compared with VL30%. No significant changes in resting hormonal concentrations were observed for any training group. Curvilinear relationships between percentage VL in the set and changes in strength and CMJ performance were observed.",2020,Both groups showed similar improvements in muscle strength and endurance variables (VL10%: 7.0-74.8%; VL30%: 4.2-73.2%).,['Twenty-five young healthy males'],"['Velocity-based resistance training', 'resistance training (RT', 'full-squat (SQ) exercise']","['physical performance', 'EMG variables', 'muscle strength and endurance variables', 'neuromuscular performance and hormonal response', 'strength and CMJ performance', 'Repetition velocity', 'resting hormonal concentrations', 'Novelty bullets •', 'neuromuscular performance', 'velocity losses', '20-m running sprint, countermovement jump (CMJ), 1RM, muscle endurance and EMG during SQ exercise, and resting hormonal concentrations', 'sprint performance', 'CMJ']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2607857'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",25.0,0.0196751,Both groups showed similar improvements in muscle strength and endurance variables (VL10%: 7.0-74.8%; VL30%: 4.2-73.2%).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Rosell', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville 41013, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Yáñez-García', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville 41013, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Custodio', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville 41013, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville 41013, Spain.'}, {'ForeName': 'Antonio G', 'Initials': 'AG', 'LastName': 'Ravelo-García', 'Affiliation': 'Institute for Technological Development and Innovation in Communications, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria 35017, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ribas-Serna', 'Affiliation': 'Department of Medical Physiology and Biophysics, University of Seville, Seville 41009, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'González-Badillo', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville 41013, Spain.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0829']
2814,18334511,"Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study.","BACKGROUND


Clinical data show that a single, 15-min i.v. infusion of ibandronate 6 mg does not significantly alter renal function. We evaluated the effect on renal function of repeated 15-min infusions of ibandronate 6 mg in women with breast cancer and bone metastases.
PATIENTS AND METHODS


Patients were randomly assigned to i.v. ibandronate 6 mg every 3-4 weeks for < or =6 months, infusion over 15 min (n = 102) or 60 min (n = 28). The primary end point was the percentage of patients with increased serum creatinine of > or =44.2 micromol/l. Blood chemistry was assessed at each visit.
RESULTS


Two per cent [2/101; 95% confidence interval (CI) 0.2-7.0] of patients in the 15-min infusion arm and no patients (0/26; 95% CI 0.0-13.2) in the 60-min infusion arm had increased serum creatinine that met the primary end point. There were no clinically relevant changes in serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria. Most adverse events were mild or moderate. No clinically relevant changes were observed in vital signs, hematology, blood chemistry, or urine analysis.
CONCLUSIONS


Ibandronate 6 mg by 15-min infusion every 3-4 weeks appear to be consistent with those renal safety profiles of 60-min infusion.",2008,"There were no clinically relevant changes in serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria.","['Patients', 'women with breast cancer and bone metastases']","['ibandronate', 'ibandronate 6 mg']","['percentage of patients with increased serum creatinine', 'serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria', 'vital signs, hematology, blood chemistry, or urine analysis', 'Blood chemistry', 'serum creatinine', 'Renal safety profiles', 'renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0379199', 'cui_str': 'Ibandronate'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised (finding)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-D-glucosaminidase'}, {'cui': 'C0051272', 'cui_str': 'alpha(2)-microglobulin'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0518766'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0708232,"There were no clinically relevant changes in serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Kantonsspital Graubünden, Chur, Switzerland. Electronic address: roger.vonmoos@onkologie.li.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Caspar', 'Affiliation': 'Kantonsspital Baden, Baden, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Angst', 'Affiliation': 'Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Inauen', 'Affiliation': 'Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'University Hospital, Salzburg, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bergstrom', 'Affiliation': 'Hoffmann-La Roche Inc., Nutley, NJ, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schmieding', 'Affiliation': 'Roche Pharma (Schweiz) AG, Reinach, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pecherstorfer', 'Affiliation': 'Wilhelminenspital, Vienna, Austria.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn038']
2815,18349029,Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK.,"BACKGROUND


To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC).
PATIENTS AND METHODS


In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles.
RESULTS


Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B.
CONCLUSION


Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.",2008,"Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively.","['Seventy-four patients with good performance status entered the trial', 'metastatic colorectal cancer (MCC', 'metastatic colorectal cancer']","['cetuximab, oxaliplatin and fluoropyrimidine', 'Cetuximab', 'oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab', 'capecitabine plus oxaliplatin (XELOX', 'XELOX + Cetuximab', 'cetuximab', 'oxaliplatin and capecitabine (XELOX) combination']","['median overall survival', 'activity and tolerability', 'response rates', 'median time to progression', 'skin rash', 'Objective partial response rates']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",74.0,0.0372894,"Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borner', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland. Electronic address: markus.borner@insel.ch.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Koeberle', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Von Moos', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Saletti', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rauch', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hess', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Trojan', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Helbling', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pestalozzi', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Caspar', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kappeler', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dietrich', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mingrone', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Institute of Medical Oncology, Inselspital, Bern, Switzerland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn058']
2816,32017688,A 12-month feasibility study to investigate the effectiveness of cryogen-cooled monopolar radiofrequency treatment for female stress urinary incontinence.,"INTRODUCTION


The purpose of this early feasibility study was to evaluate the safety and efficacy of a non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for female stress urinary incontinence (SUI).
METHODS


Subjects meeting all the inclusion and exclusion criteria were enrolled and randomized into two groups. Subjects in group 1 received one CMRF treatment and subjects in group 2 received two CMRF treatments six weeks apart. Followup visits were performed at one, four, six, and 12 months post-treatment. At each study visit, subjects performed an objective, standardized one-hour pad weight test and completed several patient-reported outcome measures, a seven-day bladder voiding diary, and safety assessments.
RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months. In addition to efficacy, the CMRF treatment was well-tolerated and safe.
CONCLUSIONS


The outcome measures evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 12 months suggests potential use as an office-based, non-surgical approach to treat mild to moderate SUI.",2020,"RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months.","['Subjects meeting all the inclusion and exclusion criteria', 'female stress urinary incontinence (SUI', 'female stress urinary incontinence']","['cryogen-cooled monopolar radiofrequency treatment', 'CMRF', 'CMRF vaginal treatment', 'non-ablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment', 'CMRF treatment']","['seven-day bladder voiding diary, and safety assessments', 'pad weight', 'safety and efficacy', 'tolerated and safe', 'SUI symptoms and quality of life']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0328095,"RESULTS


Data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective one-hour pad weight test, with a >50% reduction in pad weight from baseline for 52% of the subjects at 12 months.","[{'ForeName': 'Bruce B', 'Initials': 'BB', 'LastName': 'Allan', 'Affiliation': 'Allan Centre, Calgary, AB, Canada.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Viveve Inc., United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Husarek', 'Affiliation': 'Viveve Inc., United States.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6145']
2817,32017693,"A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.","INTRODUCTION


We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients.
METHODS


We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant.
RESULTS


We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups.
CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.",2020,"CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.","['50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group', 'people with OAB or neurogenic bladder dysfunction', 'overactive bladder and neurogenic bladder patients', 'Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms', 'overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients']","['transcutaneous tibial nerve stimulation', 'transcutaneous tibial nerve stimulation (TTNS', 'TTNS']","['marginal mean of the end-of-study PPBC score', 'patient perception of bladder condition (PPBC', 'PPBC', 'secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic Bladder'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.480228,"CONCLUSIONS


TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.","[{'ForeName': 'Blayne', 'Initials': 'B', 'LastName': 'Welk', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKibbon', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6142']
2818,31194916,Spaced Retrieval Using Static and Dynamic Images to Improve Face-Name Recognition: Alzheimer's Dementia and Vascular Dementia.,"Purpose The primary objective of this study examined whether spaced retrieval (SR) using dynamic images (video clips without audio) is more effective than SR using static images to improve face-name recognition in persons with dementia. A secondary objective examined the length of time associations were retained after participants reached criterion. A final objective sought to determine if there is a relationship between SR training and dementia diagnosis. Method A repeated-measures design analyzed whether SR using dynamic images was more effective than SR using static images for face-name recognition. Twelve participants diagnosed with Alzheimer's dementia or vascular dementia were randomly assigned to 2 experimental conditions in which the presentation of images was counterbalanced. Results All participants demonstrated improvement in face-name recognition; there was no significant difference between the dynamic and static images. Eleven of 12 participants retained the information from 1 to 4 weeks post training. Additional analysis revealed a significant interaction effect when diagnoses and images were examined together. Participants with vascular dementia demonstrated improved performance using SR with static images, whereas participants with Alzheimer's dementia displayed improved performance using SR with dynamic images. Conclusions SR using static and/or dynamic images improved face-name recognition in persons with dementia. Further research is warranted to continue exploration of the relationship between dementia diagnosis and SR performance using static and dynamic images.",2019,"Participants with vascular dementia demonstrated improved performance using SR with static images, whereas participants with Alzheimer's dementia displayed improved performance using SR with dynamic images.","['persons with dementia', ""Twelve participants diagnosed with Alzheimer's dementia or vascular dementia"", 'Participants with vascular dementia']","['spaced retrieval (SR) using dynamic images (video clips without audio', 'Spaced Retrieval Using Static and Dynamic Images']","['length of time associations', 'face-name recognition']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",12.0,0.0323075,"Participants with vascular dementia demonstrated improved performance using SR with static images, whereas participants with Alzheimer's dementia displayed improved performance using SR with dynamic images.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Viccaro', 'Affiliation': 'Department of Communication Sciences and Disorders, Long Island University Post, Brookville, NY.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Sands', 'Affiliation': 'Department of Communication Sciences and Disorders, Adelphi University, Garden City, NY.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Springer', 'Affiliation': 'Department of Psychology, Adelphi University, Garden City, NY.'}]",American journal of speech-language pathology,['10.1044/2019_AJSLP-18-0131']
2819,18385202,"Extracapsular tumor spread and the risk of local, axillary and supraclavicular recurrence in node-positive, premenopausal patients with breast cancer.","BACKGROUND


Extracapsular tumor spread (ECS) has been identified as a possible risk factor for breast cancer recurrence, but controversy exists regarding its role in decision making for regional radiotherapy. This study evaluates ECS as a predictor of local, axillary, and supraclavicular recurrence.
PATIENTS AND METHODS


International Breast Cancer Study Group Trial VI accrued 1475 eligible pre- and perimenopausal women with node-positive breast cancer who were randomly assigned to receive three to nine courses of classical combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil. ECS status was determined retrospectively in 933 patients based on review of pathology reports. Cumulative incidence and hazard ratios (HRs) were estimated using methods for competing risks analysis. Adjustment factors included treatment group and baseline patient and tumor characteristics. The median follow-up was 14 years.
RESULTS


In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005). HRs for local and axillary recurrence were 1.38 (P = 0.06) and 1.81 (P = 0.11), respectively. Following adjustment for number of lymph node metastases and other baseline prognostic factors, ECS was not significantly associated with any of the three recurrence types studied.
CONCLUSIONS


Our results indicate that the decision for additional regional radiotherapy should not be based solely on the presence of ECS.",2008,"In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005).","['premenopausal patients with breast cancer', '933 patients based on review of pathology reports', '1475 eligible pre- and perimenopausal women with node-positive breast cancer']","['classical combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil', 'ECS', 'Extracapsular tumor spread (ECS']","['HRs for local and axillary recurrence', 'supraclavicular recurrence', 'Cumulative incidence and hazard ratios (HRs', 'Extracapsular tumor spread and the risk of local, axillary and supraclavicular recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0807321', 'cui_str': 'Pathology report (record artifact)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.168059,"In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institut für Radiotherapie, Klinik Hirslanden and Swiss Group for Clinical Cancer Research (SAKK), Zurich, Switzerland. Electronic address: guenther.gruber@hirslanden.ch.'}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Cole', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Boston, MA and Department of Mathematics and Statistics, University of Vermont, Burlington, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindtner', 'Affiliation': 'The Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Golouh', 'Affiliation': 'The Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': 'Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Senology Center of Eastern Switzerland, Kantonsspital and SAKK, St Gallen, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': 'Oncologia Medica-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Fey', 'Affiliation': 'Department of Medical Oncology, Inselspital and SAKK, Bern, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group, Bern, Switzerland and University of Sydney, Sydney, Australia.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Oncology Institute of Southern Switzerland, Lugano, Switzerland and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology and Laboratory Medicine, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': 'Division of Cancer Sciences and Molecular Pathology, Faculty of Medicine, Glasgow University, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn123']
2820,30935906,Online training on how to diagnose anoperineal lesions of Crohn's disease: Do pictures matter? A nationwide randomized study.,"Any gastroenterologist must be trained to properly diagnose anoperineal lesions in patients with Crohn's disease (APLOC). The aim of this study was to establish whether adding pictures would improve teaching effectiveness of the diagnosis of APLOC to French gastroenterology trainees.
METHOD


Trainees were asked to answer a first web-based survey consisting of evaluating 12 pictures of APLOC with a closed answer questionnaire. They were then randomized in 2 groups. Group A received an online teaching with typical pictures and APLOC definitions and group B definitions only. Trainees were asked again seven days later to answer a second survey with 12 other pictures of APLOC and 14 experts also answered this survey. Diagnostic scores were expressed in %. The primary endpoint was the comparison of the score of survey 2 between the two groups of trainees. Secondary endpoints were to compare results of survey 2 between trainees of both groups and experts, and assess diagnosis of each lesion.
RESULTS


Two hundred fourty eight trainees among 465 answered survey 1, and 195 survey 2. The diagnostic score was 71.9% for groups A and B and 74.6% for experts (differences NS). After training diagnosis of ulceration was 72% for group A and 72.9% for group B, fistulae 85.2% versus 85.8%, erythema 44.1% vs. 55.6%, anoperineal scars 67.5% vs. 65.6%, and abscess 100% (differences NS).
CONCLUSION


There was no difference between the two teaching methods. Further research should be performed aiming at improving teaching material and quotation baremes.",2019,"After training diagnosis of ulceration was 72% for group A and 72.9% for group B, fistulae 85.2% versus 85.8%, erythema 44.1% vs. 55.6%, anoperineal scars 67.5% vs. 65.6%, and abscess 100% (differences NS).
","['Two hundred fourty eight trainees among 465 answered survey 1, and 195 survey 2', 'Trainees were asked to answer a first web-based survey consisting of evaluating 12 pictures of APLOC with a closed answer questionnaire', ""Crohn's disease"", ""patients with Crohn's disease (APLOC""]","['Online training', 'online teaching with typical pictures and APLOC definitions']","['diagnosis of each lesion', 'ulceration', 'teaching effectiveness', 'diagnostic score', 'Diagnostic scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0732739,"After training diagnosis of ulceration was 72% for group A and 72.9% for group B, fistulae 85.2% versus 85.8%, erythema 44.1% vs. 55.6%, anoperineal scars 67.5% vs. 65.6%, and abscess 100% (differences NS).
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Geffrier', 'Affiliation': 'Department of digestive diseases, CHU de Louis-Mourier, AP-HP, 92700 Colombes, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Parades', 'Affiliation': 'Department of proctology, groupe hospitalier Paris Saint Joseph, institut Léopold-Bellan, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Abramowitz', 'Affiliation': 'Department of proctology and digestive diseases, CHU de Bichat, AP-HP, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Benfredj', 'Affiliation': 'Department of proctology, groupe hospitalier Paris Saint Joseph, institut Léopold-Bellan, Paris, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bonnaud', 'Affiliation': 'Department of digestive diseases, clinique des Cèdres, 31700 Cornebarrieu, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bord', 'Affiliation': 'Department of proctology, clinique Beau Soleil, 34070 Montpellier, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bouchard', 'Affiliation': 'Department of proctology, hôpital Bagatelle, 33401 Talence, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bouguen', 'Affiliation': 'Department of digestive diseases, CHU de Pontchaillou, Rennes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Devulder', 'Affiliation': 'Department of digestive diseases and proctology, polyclinique de Courlancy, 51100 Reims, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Didelot', 'Affiliation': 'Department of proctology, Clinique Clementville, 34070 Montpellier, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fathallah', 'Affiliation': 'Department of proctology, Clinique St Antoine, 06004 Nice, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Higuero', 'Affiliation': 'Department of proctology, 59280 Armentieres, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Lesage', 'Affiliation': 'Department of proctology, 94120 Fontenay-sous-Bois, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nouts', 'Affiliation': 'Department of proctology, clinique Saint Augustin, 44000 Nantes, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Petit', 'Affiliation': 'Department of proctology, clinique Tivoli, 33000 Bordeaux, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pigot', 'Affiliation': 'Department of proctology, clinique St Jean-Languedoc, 31400 Toulouse, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pommaret', 'Affiliation': 'Department of proctology, groupe hospitalier Paris Saint Joseph, institut Léopold-Bellan, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Roumeguere', 'Affiliation': 'Department of proctology, clinique Tivoli, 33000 Bordeaux, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Siproudhis', 'Affiliation': 'Department of digestive diseases, CHU de Pontchaillou, Rennes, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Staumont', 'Affiliation': 'Department of proctology, clinique St Jean-Languedoc, 31400 Toulouse, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Zeitoun', 'Affiliation': 'Department of digestive diseases and proctology, CHU de Saint Antoine, AP-HP, 75012 Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'Philippe-Marteau, université Paris Sorbonne, AP-HP, pole digestif, hôpital Saint Antoine 75012 Paris, France. Electronic address: philippe.marteau@aphp.fr.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2018.12.003']
2821,30721549,Growth hormone therapy and short stature-related distress: A randomized placebo-controlled trial.,"CONTEXT


Growth hormone (GH) treatment of short healthy children is based on the belief that short stature is associated with psychosocial problems and a diminished quality of life.
OBJECTIVE


To determine the impact of GH therapy on psychosocial well-being and the ability of psychological metrics to define short stature-related distress.
METHODS


Sixty prepubertal boys with idiopathic short stature (age: 10.0 ± 1.4 years, height-SDS: -2.38 ± 0.3) were enrolled in this 4-year intervention study (1-year double-blinded, randomized, placebo-controlled [GH/placebo-2:1] and 3-year open-labelled GH therapy). Explicit (conscious/voluntary) psychological metrics (Pediatric Quality of Life Inventory [PedsQL], Silhouette Apperception Test [SAT], Rosenberg Self-Esteem Scale [RSES], Child Behavior Checklist [CBCL]) and implicit (unconscious/involuntary) psychological metrics (Single-Category Implicit Association Test for height [SC-IAT-H], Height Perception Picture Test [HPPT]). Psychosocial evaluations were performed at study entry, after 1 and 4 years.
RESULTS


At study entry, PedsQL of boys with idiopathic short stature was lower than Israeli norms (P = 0.001). After 1-year blinded intervention, only the GH-treated boys improved their actual and anticipated adult height perception (SAT, P < 0.001 and P = 0.022) with reduced short stature-related distress (SC-IAT-H, P < 0.001). At study end, RSES and SC-IAT-H improved significantly (P < 0.001), with no change in PedsQL and CBCL.
CONCLUSIONS


Our finding of improved psychosocial functioning only in the GH-treated boys after 1-year blinded intervention suggests that it was the GH therapy, rather than being enrolled in a clinical trial, which contributed to the outcome. Long-term open-labelled GH treatment significantly improved height perception and self-esteem. Future studies are needed to fully assess the relevance of complementing the routinely used explicit self-report measures with the implicit measures.",2019,"At study end, RSES and SC-IAT-H improved significantly (P < 0.001), with no change in PedsQL and CBCL.
","['and short stature-related distress', 'short healthy children', 'Sixty prepubertal boys with idiopathic short stature (age: 10.0\xa0±\xa01.4\xa0years, height-SDS']","['placebo', 'GH therapy', 'Long-term open-labelled GH', 'placebo-controlled [GH/placebo-2:1] and 3-year open-labelled GH therapy', 'Growth hormone therapy']","['psychosocial functioning', 'height perception and self-esteem', 'short stature-related distress', 'PedsQL and CBCL', 'Explicit (conscious/voluntary) psychological metrics (Pediatric Quality of Life Inventory [PedsQL], Silhouette Apperception Test [SAT], Rosenberg Self-Esteem Scale [RSES], Child Behavior Checklist [CBCL]) and implicit (unconscious/involuntary) psychological metrics ', 'actual and anticipated adult height perception']","[{'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0234426', 'cui_str': 'Apperception, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale (assessment scale)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0041654', 'cui_str': 'Unconscious'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",60.0,0.142149,"At study end, RSES and SC-IAT-H improved significantly (P < 0.001), with no change in PedsQL and CBCL.
","[{'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Shemesh-Iron', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Lazar', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Lebenthal', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Nessia', 'Initials': 'N', 'LastName': 'Nagelberg', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Tenenbaum', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Ezra', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Leffler', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Yackobovitch-Gavan', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Schoenberg-Taz', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z and Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}]",Clinical endocrinology,['10.1111/cen.13944']
2822,18325918,Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy?,"BACKGROUND


The role of chemotherapy in addition to combined endocrine therapy for premenopausal women with endocrine-responsive early breast cancer remains an open question, yet trials designed to answer it have repeatedly failed to adequately accrue. The International Breast Cancer Study Group initiated two concurrent trials in this population: in Premenopausal Endocrine Responsive Chemotherapy (PERCHE), chemotherapy use is determined by randomization and in Tamoxifen and Exemestane Trial (TEXT) by physician choice. PERCHE closed with inadequate accrual; TEXT accrued rapidly.
METHODS


From 2003 to 2006, 1317 patients (890 with baseline data) were randomly assigned to receive ovarian function suppression (OFS) plus tamoxifen or OFS plus exemestane for 5 years in TEXT. We explore patient-related factors according to whether or not chemotherapy was given using descriptive statistics and classification and regression trees.
RESULTS


Adjuvant chemotherapy was chosen for 64% of patients. Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative). Geography, patient age, tumor size and grade were also determinants, but degree of receptor positivity and human epidermal growth factor receptor 2 status were not.
CONCLUSIONS


The perceived estimation of increased risk of relapse is the primary determinant for using chemotherapy despite uncertainties regarding the degree of benefit it offers when added to combined endocrine therapy in this population.",2008,Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative).,"['Premenopausal endocrine-responsive early breast cancer', '1317 patients (890 with baseline data', 'premenopausal women with endocrine-responsive early breast cancer', 'From 2003 to 2006']","['endocrine therapy', 'ovarian function suppression (OFS) plus tamoxifen or OFS plus exemestane', 'Premenopausal Endocrine Responsive Chemotherapy (PERCHE), chemotherapy', 'chemotherapy', 'Tamoxifen and Exemestane']",['Lymph node status'],"[{'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.050565,Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative).,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston, MA, USA. Electronic address: mregan@jimmy.harvard.edu.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Pagani', 'Affiliation': 'Oncology Institute of Southern Switzerland, Ospedale Italiano, Viganello, Lugano; Swiss Group for Clinical Cancer Research, Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Walley', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Torrisi', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Francis', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Bern, Switzerland; Senology Center of Eastern Switzerland, Kantonsspital, St Gallen, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maibach', 'Affiliation': 'IBCSG Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'IBCSG Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group, Bern, Switzerland; University of Sydney, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn037']
2823,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
2824,32000729,"Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial.","BACKGROUND


Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.
METHODS


This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation.
DISCUSSION


Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, NCT03086876. Registered 22nd March 2017, https://clinicaltrials.gov/ct2/show/NCT03086876.",2020,"Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population.","['Children with intellectual disabilities', 'pre-schoolers with moderate to severe intellectual disability (EPICC-ID', '2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59\u2009months', 'preschool children with moderate to severe intellectual disabilities', 'young children with moderate to severe intellectual disabilities']","['parent mediated intervention', 'NICE guidelines favour Stepping Stones Triple P (SSTP', 'SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location']",['parent reports and structured observations of behaviour'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0558039', 'cui_str': 'Behavior Observation'}]",258.0,0.170216,"Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population.","[{'ForeName': 'Olayinka', 'Initials': 'O', 'LastName': 'Farris', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Royston', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. r.royston@ucl.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Absoud', 'Affiliation': ""Evelina London Children's Hospital, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH and King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychological Sciences, Birbeck University of London, Malet Street, London, WC1E 7HX, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, Royal Free Medical School, NW3 2PF, London, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Kyriakopoulos', 'Affiliation': ""South London and Maudsley NHS Foundation Trust and Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO66 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Oulton', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, WC1N 3JH, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Paliokosta', 'Affiliation': 'The Effra Clinic, 4th Floor, 86-90 Paul Street, London, EC2A 4NE, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Panca', 'Affiliation': 'Research Department of Primary Care and Population Health, Royal Free Medical School, NW3 2PF, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paulauskaite', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Poppe', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ricciardi', 'Affiliation': 'Department of Statistical Science, University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Evelina London Children's Hospital, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH and King's College London, Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Summerson', 'Affiliation': ', Contact, 209-211 City Road, EC1V 1JN, London, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Sutcliffe', 'Affiliation': 'Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool Victoria Hospital, Whinney Heys Road, Blackpool, FY3 8NR, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hassiotis', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",BMC psychiatry,['10.1186/s12888-020-2451-6']
2825,31913908,Estimating Serotype-specific Efficacy of Pneumococcal Conjugate Vaccines Using Hierarchical Models.,"Pneumococcal conjugate vaccines target 10 or 13 specific serotypes. To evaluate the overall efficacy of these products, the vaccine-targeted serotypes are typically aggregated into a single group. However, it is often desirable to evaluate variations in effects for different serotypes. These serotype-specific estimates are often based on small counts, resulting in a high degree of uncertainty (i.e., large standard errors and wide confidence intervals). An alternative is to use a hierarchical Bayesian statistical model, which estimates overall effectiveness while simultaneously providing estimates of serotype-specific vaccine effects. These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty. We reanalyzed published data from a randomized controlled trial on the efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) against community-acquired pneumonia caused by vaccine-targeted serotype using a hierarchical model. This model provides a potential framework for obtaining estimates of serotype-specific vaccine effects with reduced MSEs.",2020,These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty.,[],"['pneumococcal conjugate vaccines', 'PCV13']",[],[],"[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]",[],,0.0541208,These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty.,"[{'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Warren', 'Affiliation': 'From the Department of Biostatistics, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Weinberger', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001135']
2826,31859245,"Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.","BACKGROUND


Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated patients with relapsed or refractory multiple myeloma. We further investigated the safety and activity of belantamab mafodotin in the DREAMM-2 study.
METHODS


DREAMM-2 is an open-label, two-arm, phase 2 study done at 58 multiple myeloma specialty centres in eight countries. Patients (aged ≥18 years) with relapsed or refractory multiple myeloma with disease progression after three or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody with an Eastern Cooperative Oncology Group performance status of 0-2 were recruited, centrally randomly assigned (1:1) with permuted blocks (block size 4), and stratified by previous lines of therapy (≤4 vs >4) and cytogenetic features to receive 2·5 mg/kg or 3·4 mg/kg belantamab mafodotin via intravenous infusion every 3 weeks on day 1 of each cycle until disease progression or unacceptable toxicity. The intention-to-treat population comprised all randomised patients, regardless of treatment administration. The safety population comprised all patients who received at least one dose of belantamab mafodotin. The primary outcome was the proportion of randomly assigned patients in the intention-to-treat population who achieved an overall response, as assessed by an independent review committee. This study is registered with ClinicalTrials.gov, NCT03525678, and is ongoing.
FINDINGS


Between June 18, 2018, and Jan 2, 2019, 293 patients were screened and 196 were included in the intention-to-treat population (97 in the 2·5 mg/kg cohort and 99 in the 3·4 mg/kg cohort). As of June 21, 2019 (the primary analysis data cutoff date), 30 (31%; 97·5% CI 20·8-42·6) of 97 patients in the 2·5 mg/kg cohort and 34 (34%; 23·9-46·0) of 99 patients in the 3·4 mg/kg cohort achieved an overall response. The most common grade 3-4 adverse events in the safety population were keratopathy (in 26 [27%] of 95 patients in the 2·5 mg/kg cohort and 21 [21%] of 99 patients in the 3·4 mg/kg cohort), thrombocytopenia (19 [20%] and 33 [33%]), and anaemia (19 [20%] and 25 [25%]); 38 (40%) of 95 patients in the 2·5 mg/kg cohort and 47 (47%) of 99 in the 3·4 mg/kg cohort reported serious adverse events. Two deaths were potentially treatment related (one case of sepsis in the 2·5 mg/kg cohort and one case of haemophagocytic lymphohistiocytosis in the 3·4 mg/kg cohort).
INTERPRETATION


Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma.
FUNDING


GlaxoSmithKline.",2020,"INTERPRETATION


Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma.
","['23·9-46·0) of 99 patients in the 3·4 mg/kg cohort achieved an overall response', 'Between June 18, 2018, and Jan 2, 2019, 293 patients were screened and 196 were included in the intention-to-treat population (97 in the 2·5 mg/kg cohort and 99 in the 3·4 mg/kg cohort', 'heavily pre-treated patients with relapsed or refractory multiple myeloma', 'relapsed or refractory multiple myeloma', '58 multiple myeloma specialty centres in eight countries', 'Patients (aged ≥18 years) with relapsed or refractory multiple myeloma with disease progression after three or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody with an Eastern Cooperative Oncology Group performance status of 0-2', 'patients with relapsed or refractory multiple myeloma']",['Belantamab mafodotin'],"['serious adverse events', 'thrombocytopenia', 'anaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",293.0,0.268505,"INTERPRETATION


Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma.
","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA. Electronic address: sloni01@emory.edu.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Badros', 'Affiliation': 'University of Maryland at Baltimore, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Trudel', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, NY, USA.'}, {'ForeName': 'Al-Ola', 'Initials': 'AO', 'LastName': 'Abdallah', 'Affiliation': 'University of Kansas Cancer Center, Fairway, KS, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Lendvai', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York City, NY, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Attaya', 'Initials': 'A', 'LastName': 'Suvannasankha', 'Affiliation': 'Indiana University Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany; University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Haematology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Libby', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Arnulf', 'Affiliation': 'Immuno-hématologie, Hôpital Saint-Louis, APHP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'CHRU de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'CHU de Bordeaux, Hôpital Haut Lévêque, Pessac, France.'}, {'ForeName': 'K Martin', 'Initials': 'KM', 'LastName': 'Kortüm', 'Affiliation': 'Universitätsklinikum Würzburg, Medizinische Klinik II, Würzburg, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodríguez-Otero', 'Affiliation': 'Clínica Universidad de Navarra-Pamplona, Navarra, Spain.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Baz', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'CHU de Nantes - Hôtel Dieu Service Hématologie Clinique, Nantes, France.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hoos', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zhi', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Jewell', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Elisha J', 'Initials': 'EJ', 'LastName': 'Dettman', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Simona Degli', 'Initials': 'SD', 'LastName': 'Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30788-0']
2827,32017001,"Effects of mesalazine combined with bifid triple viable on intestinal flora, immunoglobulin and levels of cal, MMP-9, and MPO in feces of patients with ulcerative colitis.","OBJECTIVE


Ulcerative colitis (UC) commonly occurs in young and middle-aged people and is characterized by frequent attacks and difficult cure. Mesalazine is often applied in the initial treatment of UC, but it can lead to serious adverse effects. Its combination with bifid triple viable could mitigate adverse effects. This study aims to explore the effects of mesalazine combined with bifid triple viable on the intestinal flora, immunoglobulin (Ig), and levels of calprotectin (Cal), matrix metalloproteinase-9 (MMP-9), myeloperoxidase (MPO) in feces of UC patients.
PATIENTS AND METHODS


A total of 180 UC patients in our hospital were divided into two groups with 90 cases in each one. Patients in control group were treated with oral mesalazine (1.5 g/d), and those in the treatment group were treated with oral mesalazine (1.5 g/d) combined with bifid triple viable (1.26 g/d) for 2 months. Treatment effects in both groups following the therapeutic period were observed accordingly. Feces of patients in the two groups were collected for detecting intestinal microorganism and the levels of Cal, MMP-9, and MPO. Serum levels of IgG, IgA, and IgM in each patient were detected by enzyme-linked immunosorbent assay (ELISA).
RESULTS


The overall response rate of the treatment group (91.11%) was significantly higher than that of control group (68.89%; p=0.000). The abundances of intestinal microflora, including Bifidobacterium, Actinomycetes, Rikenellaceae, Genus VI of Acidaminococcaceae, and Metascardovia in treatment group were remarkably higher than those in control group. The abundances of intestinal microorganisms such as Phocaeicola, Lawsonia intracelluaris, Streptococcus, Ruminococcaceae, and Clostridium in control group were significantly higher than those in treatment group. After treatment, serum levels of IgG and IgM of patients in treatment group were lower than those in control group, with IgG of (15.14±0.98) (p=0.031) and IgM of (1.50±0.18) (p=0.000). No statistical difference in IgG level was observed between treatment group and control group after treatment (p=0.871). After treatment, the levels of Cal and MMP-9 in feces of patients in treatment group were significantly lower than those in control group with Cal of (79.81±5.42) (p=0.000) and MMP-9 of (4.89±0.98) (p=0.000). There was no statistical difference in the MPO level between treatment group and control group after treatment (p=0.871).
CONCLUSIONS


Mesalazine combined with bifid triple viable is able to enhance the curative effect for UC, improve the composition of intestinal flora, weaken the immune response, and reduce levels of Cal and MMP-9 in the intestinal tract.",2020,"There was no statistical difference in the MPO level between treatment group and control group after treatment (p=0.871).
","['feces of UC patients', 'patients with ulcerative colitis', 'young and middle-aged people', '180 UC patients in our hospital']","['oral mesalazine', 'Mesalazine', 'mesalazine']","['levels of Cal and MMP-9 in feces', 'overall response rate', 'serum levels of IgG and IgM', 'intestinal flora, immunoglobulin and levels of cal, MMP-9, and MPO in feces', 'abundances of intestinal microorganisms such as Phocaeicola, Lawsonia intracelluaris, Streptococcus, Ruminococcaceae, and Clostridium', 'abundances of intestinal microflora, including Bifidobacterium, Actinomycetes, Rikenellaceae, Genus VI of Acidaminococcaceae, and Metascardovia', 'Serum levels of IgG, IgA, and IgM', 'intestinal flora, immunoglobulin (Ig), and levels of calprotectin (Cal), matrix metalloproteinase-9 (MMP-9), myeloperoxidase (MPO', 'MPO level', 'IgG level', 'levels of Cal, MMP-9, and MPO']","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital (finding)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0912079', 'cui_str': 'myelopoietin'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0752045', 'cui_str': 'Lawsonia Bacteria'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1080664', 'cui_str': 'Family Rikenellaceae (organism)'}, {'cui': 'C0042447', 'cui_str': 'Acidaminococcaceae'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}]",180.0,0.0280008,"There was no statistical difference in the MPO level between treatment group and control group after treatment (p=0.871).
","[{'ForeName': 'X-E', 'Initials': 'XE', 'LastName': 'Jiang', 'Affiliation': ""Department of Colon and Rectal Surgery, Fenghua District People's Hospital, Ningbo, China. yangzhang@jlu.edu.cn.""}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'X-J', 'Initials': 'XJ', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202001_20079']
2828,31736335,"Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial.","BACKGROUND


Goals of management in patients with heart failure and reduced ejection fraction include reducing death and hospitalizations, and improving health status (symptoms, physical function, and quality of life). In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), sodium-glucose cotransporter-2 inhibitor, dapagliflozin, reduced death and hospitalizations, and improved symptoms in patients with heart failure and reduced ejection fraction. In this analysis, we examine the effects of dapagliflozin on a broad range of health status outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
METHODS


KCCQ was evaluated at randomization, 4 and 8 months. Patients were divided by baseline KCCQ total symptom score (TSS); Cox proportional hazards models examined the effects of dapagliflozin on clinical events across these subgroups. We also evaluated the effects of dapagliflozin on KCCQ-TSS, clinical summary score, and overall summary score. Responder analyses were performed to compare proportions of dapagliflozin versus placebo-treated patients with clinically meaningful changes in KCCQ at 8 months.
RESULTS


A total of 4443 patients had available KCCQ at baseline (median KCCQ-TSS, 77.1 [interquartile range, 58.3-91.7]). The effects of dapagliflozin vs placebo on reducing cardiovascular death or worsening heart failure were consistent across the range of KCCQ-TSS (lowest to highest tertile: hazard ratio, 0.70 [95% CI, 0.57-0.86]; hazard ratio, 0.77 [95% CI, 0.61-0.98]; hazard ratio, 0.62 [95% CI, 0.46-0.83];  P  for heterogeneity=0.52). Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, clinical summary score, and overall summary score at 8 months (2.8, 2.5 and 2.3 points higher versus placebo;  P <0.0001 for all). Fewer patients treated with dapagliflozin had a deterioration in KCCQ-TSS (odds ratio, 0.84 [95% CI, 0.78-0.90];  P <0.0001); and more patients had at least small, moderate, and large improvements (odds ratio, 1.15 [95% CI, 1.08-1.23]; odds ratio, 1.15 [95% CI, 1.08-1.22]; odds ratio, 1.14 [95% CI, 1.07-1.22]; number needed to treat=14, 15, and 18, respectively;  P <0.0001 for all; results consistent for KCCQ clinical summary score and overall summary score).
CONCLUSIONS


Dapagliflozin reduced cardiovascular death and worsening heart failure across the range of baseline KCCQ, and improved symptoms, physical function, and quality of life in patients with heart failure and reduced ejection fraction. Furthermore, dapagliflozin increased the proportion of patients experiencing at least small, moderate, and large improvements in health status; these effects were clinically important.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03036124.",2020,"Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, -CSS and - OSS at 8 months (2.8, 2.5 and 2.3 points higher vs. placebo; P <0.0001 for all).","['patients with HFrEF', 'Patients with Heart Failure and Reduced Ejection Fraction', 'patients with heart failure and reduced ejection fraction (HFrEF']","['dapagliflozin', 'Dapagliflozin', 'dapagliflozin versus placebo']","['cardiovascular death or worsening HF', 'Symptoms, Function and Quality of Life', 'symptoms, physical function and quality of life', 'death and hospitalizations, and improving health status (symptoms, physical function and quality of life', 'mean KCCQ-TSS, -CSS and - OSS', 'Kansas City Cardiomyopathy Questionnaire (KCCQ', 'KCCQ-TSS, clinical summary score (CSS) and overall summary score (OSS', 'death and hospitalizations, and improved symptoms', 'cardiovascular death', 'deterioration in KCCQ-TSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4443.0,0.191932,"Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, -CSS and - OSS at 8 months (2.8, 2.5 and 2.3 points higher vs. placebo; P <0.0001 for all).","[{'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Argentina (M.D.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St Michael's Hospital, University of Toronto, Canada (S.V.).""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita Osaka, Japan (M.K.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet, Department of Cardiology, University of Copenhagen, Denmark (L.K.).'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Argentina (F.A.M.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Niklasson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044138']
2829,31997114,"ERG shrinks by 10% when reducing dark adaptation time to 10 min, but only for weak flashes.","PURPOSE


To compare dark-adapted (DA) ERG between 10, 15 and 20 min of dark adaptation (DA).
METHODS


In a counterbalanced random block design, 40 healthy adult subjects were dark-adapted for 10, 15 or 20 min before we recorded ERGs to nine flash strengths from 0.001 to 10.0 cd s/m 2  (dilated pupils) with a DTL-like electrode. Before and between sessions, the room was lit. Apart from choosing a wider range of stimulus strengths, and adding shorter DA times, the recordings fully complied with the ISCEV ERG Standard, namely using corneal electrodes, mydriasis and a standard DA sequence.
RESULTS


The a-wave amplitude was not affected by any adaptation condition. For the b-wave amplitude, effects of reduced DA time are stronger for weaker flashes: Reducing DA from 20 to 10 min had no measurable effect on the DA 3 ERG, but reduced the DA 0.01 b-wave significantly (p < 0.0001) to 87 ± 2% (mean ± SEM). The DA 0.001 b-wave (not part of the ISCEV ERG Standard) was more affected (down to 72 ± 4%). There was a small, but significant, increase, only for weak flashes, in a- and b-wave peak times for 20 compared to 10-min dark adaptation time.
CONCLUSION


Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG. The reduction in DA 0.01 ERGs to 87 ± 2% agrees with Hamilton and Graham (Doc Ophthalmol 133:11-19, 2016. https://doi.org/10.1007/s10633-016-9554-x ) who found 90 ± 2% and with Asakawa et al. (Doc Ophthalmol 139:33-44, 2019. https://doi.org/10.1007/s10633-019-09693-8 ) who found 83%. Pending verification in pathophysiological states, the current results suggest that one might be able to correct for the 10% amplitude loss when gaining 10 min through shortened DA.",2020,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,['40 healthy adult subjects'],"['dark-adapted (DA) ERG between 10, 15 and 20\xa0min of dark adaptation (DA']","['Reducing dark adaptation time', 'weak flashes, in a- and b-wave peak times']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",40.0,0.0213724,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bach', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. michael.bach@uni-freiburg.de.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Meroni', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}, {'ForeName': 'Sven P', 'Initials': 'SP', 'LastName': 'Heinrich', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}]",Documenta ophthalmologica. Advances in ophthalmology,['10.1007/s10633-020-09751-6']
2830,31640736,A placebo-controlled trial of folic acid and betaine in identical twins with Angelman syndrome.,"BACKGROUND


Angelman syndrome (AS) is a neurodevelopmental disorder that is caused by maternal genetic deficiency of a gene that encodes E6-AP ubiquitin-protein ligase (gene symbol UBE3A) mapping to chromosome 15q11-q13. AS leads to stiff and jerky gait, excess laughter, seizures, and severe intellectual disability. In some parts of the brain, the paternally inherited UBE3A gene is subject to genomic imprinting by the action of the UBE3A-antisense transcript (UBE3A-ATS) on the paternally inherited allele. Consequently, only the maternally inherited UBE3A gene is expressed in mature neurons. AS occurs due to deletions of the maternal 15q11 - 13 region, paternal uniparental disomy (UPD), imprinting center defects, mutations in the maternal UBE3A gene, or other unknown genetic malfunctions that result in a silenced maternal UBE3A gene in the specific imprinted regions of the brain.
RESULTS


A potential treatment strategy for AS is to increase methylation of UBE3A-ATS to promote expression of the paternal UBE3A gene and thus ameliorate the clinical phenotypes of AS. We treated two sets of male identical twins with class I deletions with a 1 year treatment trial of either betaine and folic acid versus placebo. We found no statistically significant changes in the clinical parameters tested at the end of the 1 year trial, nor did we find any significant adverse events.
CONCLUSIONS


This study tested the hypothesis that by increasing the methylation of the UBE3A-antisense transcript in Angelman syndrome to promote expression of the silenced paternal UBE3A gene we may ameliorate the clinical phenotypes of AS. We treated two sets of identical twins with placebo versus betaine and folic acid. Although this study represented a novel approach to treating Angelman syndrome, the differences in the developmental testing results was not significant. This paper also discusses the value of monozygotic twin studies in minimizing confounding variables and its utility in conducting small treatment studies.
TRIAL REGISTRATION


NCT00348933 . Registered 6 July 2006.",2019,"We found no statistically significant changes in the clinical parameters tested at the end of the 1 year trial, nor did we find any significant adverse events.
","['identical twins with Angelman syndrome', 'male identical twins with class']","['placebo', 'betaine and folic acid versus placebo', 'folic acid and betaine', 'placebo versus betaine and folic acid']","['stiff and jerky gait, excess laughter, seizures, and severe intellectual disability']","[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0162635', 'cui_str': 'Puppet Children'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041432', 'cui_str': 'Twins, Identical'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0023133', 'cui_str': 'Laughter'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036857', 'cui_str': 'Severe mental handicap'}]",13.0,0.0406099,"We found no statistically significant changes in the clinical parameters tested at the end of the 1 year trial, nor did we find any significant adverse events.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Division of Genetics and Genomic Medicine, Department of Pediatrics, University of California at Irvine, 101 The City Drive South, Orange, CA, 92868, USA.'}, {'ForeName': 'Terry Jo', 'Initials': 'TJ', 'LastName': 'Bichell', 'Affiliation': 'Consortium for Outcome Measures and Biomarkers for Neurodevelopmental Disorders, Nashville, TN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Golden', 'Affiliation': ""Division of Genetics and Metabolism, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Anselm', 'Affiliation': ""Department of Neurology, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Waisbren', 'Affiliation': ""Division of Genetics and Metabolism, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Bacino', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Sarika U', 'Initials': 'SU', 'LastName': 'Peters', 'Affiliation': 'Department of Pediatrics, Vanderbilt University, Vanderbilt Kennedy Center for Research on Human Development, Nashville, TN, USA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Kimonis', 'Affiliation': 'Division of Genetics and Genomic Medicine, Department of Pediatrics, University of California at Irvine, 101 The City Drive South, Orange, CA, 92868, USA. vkimonis@uci.edu.'}]",Orphanet journal of rare diseases,['10.1186/s13023-019-1216-0']
2831,17018708,Incidence and risk factors of central nervous system recurrence in aggressive lymphoma--a survey of 1693 patients treated in protocols of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).,"BACKGROUND


Central nervous system (CNS) relapse is a devastating and usually fatal complication of aggressive lymphoma. The extent of the disease, the proliferation rate and the sites of extranodal involvement have been discussed as risk factors. We analyzed the patients treated on protocols of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL) between 1990 and 2000, evaluated the rate and prognostic factors for CNS recurrence and developed a risk model trying to identify subsets of patients suitable for future prophylactic strategies.
PATIENTS AND METHODS


From 1993 to 2000, 1399 patients [<or=60 years with normal lactate dehydrogenase (LDH) and >60 years irrespective of LDH] were randomized to receive six cycles of combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)-21, CHOP-14 or six cycles of CHOP+etoposide (CHOEP)-21, CHOEP-14 in a 2x2 factorial study design in the NHL-B1/B2 studies. From 1990 to 1997, 312 patients<or=60 years with an elevated LDH were randomized to five cycles CHOEP+involved field (IF) radiotherapy or three cycles CHOEP followed by high-dose BCNU, etoposide, cytarabine and melphalan (BEAM) and autologous stem-cell transplantation (NHL-A study).
RESULTS


A total number of 1711 patients were initially eligible for this study, of whom 18 patients had to be excluded due to primary CNS involvement. In the remaining 1693 assessable patients, 37 cases of relapse or progression to the CNS (2.2%) were observed. The protocol asked for an intrathecal (i.th.) prophylaxis in patients with lymphoblastic lymphoma only (n=17), but overall 71 patients (71 of 1693=4.2%) received prophylaxis by decision of the treating physicians. Multivariate Cox regression analysis identified increased LDH (P<0.001) and involvement of more than one extranodal site (P=0.002) as independent predictors of CNS recurrence in the NHL-B1/B2 study population. Treatment with etoposide also evolved as a prognostic factor because the risk of CNS failure was significantly reduced after CHOEP (P=0.017). Elderly patients presenting with both an elevated LDH and lymphoma involvement in liver, bladder or adrenals had an up to 15-fold risk of spread of the disease to the CNS.
CONCLUSION


The incidence of CNS relapse in 1693 patients treated for aggressive lymphomas on DSHNHL protocols from 1990 to 2000 was low (2.2%), although CNS prophylaxis was administered to <5% of patients. Thus, a general prophylaxis for all patients is not warranted, the less so since the effectiveness of i.th. prophylaxis itself is judged controversially. Increased LDH and involvement of more than one extranodal site were confirmed as independent risk factors. A cumulative 20% incidence of CNS disease in certain prognostic subgroups of elderly patients may render these candidates for i.th. prophylaxis; however, this approach would imply a potential overtreatment of approximately 80% of these patients deemed at high risk.",2007,Multivariate Cox regression analysis identified increased LDH (P<0.001) and involvement of more than one extranodal site (P=0.002) as independent predictors of CNS recurrence in the NHL-B1/B2 study population.,"[""patients treated on protocols of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL) between 1990 and 2000"", 'Elderly patients presenting with both an elevated LDH and lymphoma involvement in liver, bladder or adrenals had an up to 15-fold risk of spread of the disease to the CNS', ""1693 patients treated in protocols of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL"", '1693 patients treated for aggressive lymphomas', 'A total number of 1711 patients were initially eligible for this study, of whom 18 patients had to be excluded due to primary CNS involvement', 'patients with lymphoblastic lymphoma only (n=17), but overall 71 patients (71 of 1693=4.2%) received prophylaxis by decision of the treating physicians', 'From 1990 to 1997, 312 patients<or=60 years with an elevated LDH', 'From 1993 to 2000, 1399 patients [<or=60 years with normal lactate dehydrogenase (LDH) and >60 years irrespective of LDH']","['CHOEP+involved field (IF) radiotherapy or three cycles CHOEP followed by high-dose BCNU, etoposide, cytarabine and melphalan (BEAM) and autologous stem-cell transplantation (NHL-A study', 'combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)-21, CHOP-14 or six cycles of CHOP+etoposide (CHOEP)-21, CHOEP-14', 'etoposide']","['incidence of CNS relapse', 'CNS recurrence', 'risk of CNS failure', 'relapse or progression to the CNS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}]","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0355971,Multivariate Cox regression analysis identified increased LDH (P<0.001) and involvement of more than one extranodal site (P=0.002) as independent predictors of CNS recurrence in the NHL-B1/B2 study population.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Boehme', 'Affiliation': 'Department of Haematology, General Hospital St Georg, Hamburg. Electronic address: volkmar.boehme@ak-stgeorg.lbk-hh.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zeynalova', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, University Leipzig.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kloess', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, University Leipzig.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Loeffler', 'Affiliation': 'Institute of Medical Informatics, Statistics and Epidemiology, University Leipzig.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kaiser', 'Affiliation': 'Medical Department of Haematology, St Bernward Hospital, Hildesheim.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pfreundschuh', 'Affiliation': 'Department of Internal Medicine I, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Haematology, General Hospital St Georg, Hamburg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdl327']
2832,17071931,"Initial chemotherapy with mitoxantrone, chlorambucil, prednisone impairs the collection of stem cells in patients with indolent lymphomas--results of a randomized comparison by the German Low-Grade Lymphoma Study Group.","Myeloablative radio-chemotherapy with subsequent autologous stem cell transplantation (ASCT) significantly prolongs progression free and probably overall survival in follicular lymphoma (FL) in first remission. The current trial explored prospectively the rate of successful stem cell mobilization in patients with advanced stage FL after initial therapy with either Mitoxantrone, Chlorambucil, Prednisone (MCP) or Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) as part of a prospective randomized comparison of both regimens. ASCT patients received Dexa-BEAM (Dexamethasone, BCNU, Melphalan, Etoposide, Cytarabine) for mobilization of stem cells. Stem cells were collected and a minimum of 2x2.0x106/kg bw CD34+ was required for ASCT. Of 79 evaluable patients, 58 (73%) had follicular lymphoma, 13 (16%) mantle cell lymphoma and 8 (10%) lymphoplasmacytic lymphoma. In the 45 patients assigned to CHOP, stem cell collection was successful in 42 cases (93%, 95% CI 82% to 99%). This high mobilization rate after CHOP could be confirmed in 61 subsequent patients (87%). In contrast, after MCP therapy stem cell collection was successful in only 15 of 34 patients (44%, 95% CI 27% to 62%; P=0.0003). In conclusion, initial therapy with MCP significantly impairs the ability to collect stem cells and should be avoided for first line therapy of younger patients potentially qualifying for high dose consolidation and ASCT in first remission.",2007,"In the 45 patients assigned to CHOP, stem cell collection was successful in 42 cases (93%, 95% CI 82% to 99%).","['patients with indolent lymphomas', 'patients with advanced stage FL after initial therapy with either', '79 evaluable patients, 58 (73%) had follicular lymphoma, 13 (16%) mantle cell lymphoma and 8 (10%) lymphoplasmacytic lymphoma']","['MCP', 'Myeloablative radio-chemotherapy with subsequent autologous stem cell transplantation (ASCT', 'mitoxantrone, chlorambucil, prednisone', 'Dexa-BEAM (Dexamethasone, BCNU, Melphalan, Etoposide, Cytarabine', 'Mitoxantrone, Chlorambucil, Prednisone (MCP) or Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0906090', 'cui_str': 'DEXA-BEAM'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]",[],,0.0454783,"In the 45 patients assigned to CHOP, stem cell collection was successful in 42 cases (93%, 95% CI 82% to 99%).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nickenig', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern; Institute of Medical Informatics, Biometry and Epidemiology, University of Munich.'}, {'ForeName': 'W-D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': 'Department of Hematology and Oncology, Charité Campus Berlin-Buch.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dörken', 'Affiliation': 'Department of Hematology and Oncology, Charité Berlin Campus Virchow-Klinikum.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Freund', 'Affiliation': 'Division of Hematology and Oncology, University Rostock.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huber', 'Affiliation': 'Department of Internal Medicine III, University of Mainz.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis and Oncology, Hannover Medical School.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': 'Department of Hematology and Oncology, Georg-August University, Göttingen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Forstpointner', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern. Electronic address: Wolfgang.Hiddemann@med.uni-muenchen.de.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdl348']
2833,32006484,Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial.,"PURPOSE


To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study).
DESIGN


Pragmatic randomized control trial (RCT).
METHODS


Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI).
RESULTS


A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA ""severe"" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3.
CONCLUSIONS


TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.",2020,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","['Four hundred and fifty-three patients were recruited', 'patients presenting with advanced open angle glaucoma in a publicly funded health service', 'Participants with newly diagnosed advanced glaucoma in at least one eye were recruited', 'participants in the Treatment of Advanced Glaucoma Study (TAGS', 'participants enrolled in the Treatment of Advanced Glaucoma Study (TAGS) DESIGN', 'Patients with open angle glaucoma presenting with advanced glaucoma in at least one eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria of severe defect']","['primary augmented trabeculectomy or primary medical management', 'TAGS']","['severe visual field mean deviation (MD', 'mean LogMAR visual acuity of the index eye', 'mean visual field MD', 'Visual field profile defined by the HPA classification, clinical characteristics, Quality of life measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3) and Glaucoma Profile Instrument (GPI']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",453.0,0.352301,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom. Electronic address: anthony.king@nottingham.ac.uk.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fernie', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burr', 'Affiliation': 'University of St. Andrews, St. Andrews, Fife, United Kingdom.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sparrow', 'Affiliation': 'University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.01.026']
2834,31606288,Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial.,"INTRODUCTION


The ability of breast magnetic resonance imaging (MRI) to predict pathologic complete response (pCR) to neoadjuvant systemic therapy (NST) varies across biological subtypes. We sought to determine how well breast MRI findings following initial treatment on the phase III BrighTNess trial correlated with pCR in patients with triple negative breast cancer (TNBC).
METHODS


Baseline and mid-treatment imaging and pathologic response data were available in 519 patients with stage II-III TNBC who underwent NST as per protocol. MRI complete response (mCR) was defined as disappearance of all target lesion(s) and MRI partial response (mPR) as a ≥50% reduction in the largest tumor diameter.
RESULTS


Overall, mCR was demonstrated in 116 patients (22%), whereas 166 (32%) had mPR and 237 (46%) had stable/progressive disease (SD/PD). The positive predictive value (PPV), negative predictive value, and overall accuracy of the mid-treatment MRI for pCR were 78%, 56%, and 61%, respectively; accuracy did not differ significantly between gBRCA mutation carriers and non-carriers (52% vs. 63%, p = 0.10). When compared to patients with SD/PD, those with mPR or mCR were 3.35-fold (95% CI 2.07-5.41) more likely to have pCR at surgery. MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
CONCLUSIONS


Complete response on mid-treatment MRI in the BrighTNess trial had a PPV of 78% for demonstration of pCR after completion of NST in TNBC. However, a substantial proportion of patients with mPR or SD/PD also achieved a pCR.
CLINICAL TRIAL REGISTRATION


NCT02032277.",2020,"MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
","['patients with triple negative breast cancer (TNBC', '519 patients with stage II-III TNBC who underwent', 'triple-negative breast cancer']","['NST', 'neoadjuvant chemotherapy', 'neoadjuvant systemic therapy (NST', 'breast magnetic resonance imaging (MRI', 'magnetic resonance imaging']","['MRI response', 'MRI complete response (mCR', 'positive predictive value (PPV), negative predictive value, and overall accuracy of the mid-treatment MRI for pCR', 'disappearance of all target lesion(s) and MRI partial response (mPR', 'stable/progressive disease (SD/PD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",519.0,0.128186,"MRI response during NST was significantly associated with eligibility for breast-conserving surgery following completion of treatment (93.1% for mCR vs. 81.6% for SD/PD, p < 0.001).
","[{'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Breast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. Electronic address: mgolshan@bwh.harvard.edu.""}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wong', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Jens Bodo', 'Initials': 'JB', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Texas Oncology-Baylor Sammons Cancer Center/U.S. Oncology, Dallas, TX, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': ""Breast Oncology Program, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation and Virginia Commonwealth University Massey Cancer Center, Richmond, VA, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.10.002']
2835,20093351,A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial.,"BACKGROUND


The epirubicin with cisplatin and infusional 5-fluorouracil (5-FU) (ECisF) regimen was found to be highly active in the treatment of metastatic breast cancer and as neoadjuvant therapy. The UK TRAFIC (trial of adjuvant 5-FU infusional chemotherapy) trial (CRUK/95/007) compared this schedule with 5-FU, epirubicin and cyclophosphamide (FEC60) as adjuvant therapy in patients with early breast cancer.
METHODS


In this multicentre, open-label, phase III randomised controlled trial, 349 women were randomly assigned to receive i.v. ECisF [epirubicin 60 mg/m(2), day 1, cisplatin 60 mg/m(2), day 1 and 5-FU 200 mg/m(2) by daily 24-h infusion (n = 172)] or FEC [5-FU 600 mg/m(2), day 1, epirubicin 60 mg/m(2), day 1 and cyclophosphamide 600 mg/m(2), day 1 (n = 177)]. Both treatments were delivered every 3 weeks for six cycles. The primary end point was relapse-free interval (RFI). TRAFIC is registered as an International Standard Randomised Controlled Trial (ISRCTN 83324925).
RESULTS


All randomised patients were included in the intent-to-treat population. With a median follow-up of 112 months, there was no significant difference in RFI between the treatment groups [hazard ratio 0.84 (95% confidence interval 0.60-1.19); P = 0.33]. Toxic effects were more frequent in patients allocated to ECisF.
CONCLUSIONS


While limited by size, TRAFIC has long follow-up. No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.",2010,No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.,"['349 women', 'patients with early breast cancer', 'early breast cancer']","['epirubicin 60 mg/m(2), day 1, cisplatin 60 mg/m(2), day 1 and 5-FU 200 mg/m(2) by daily 24-h infusion', 'infusional ECisF', '5-FU, epirubicin and cyclophosphamide (FEC60', 'conventional FEC', 'ECisF', 'FEC [5-FU 600 mg/m(2), day 1, epirubicin 60 mg/m(2), day 1 and cyclophosphamide', 'epirubicin with cisplatin and infusional 5-fluorouracil (5-FU']","['relapse-free interval (RFI', 'RFI', 'Toxic effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",349.0,0.212646,No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sirohi', 'Affiliation': 'Department of Medical Oncology, Max Cancer Centre, Max Healthcare, New Delhi, India (formerly at The Royal Marsden NHS Foundation Trust).'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""A'Hern"", 'Affiliation': 'ICR Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, Surrey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Coombes', 'Affiliation': 'ICR Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, Surrey.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'ICR Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, Surrey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Department of Oncology and Centre for Postgraduate Medical Research and Education, Institute of Cancer Research Clinical Trials and Statistics Unit, Royal Bournemouth Hospital, Bournemouth.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""Non-Surgical Oncology, Institute of Cancer Research Clinical Trials and Statistics Unit, St James's University Hospital, Leeds.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Medical Oncology, Airedale General Hospital, Keighley.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medicine, The Royal Marsden NHS Foundation Trust, London & Sutton; Mid Kent Oncology Centre, Maidstone Hospital, Sutton, Surrey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Oncology Department, Pembroke Suite, Salisbury District Hospital, Salisbury.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ebbs', 'Affiliation': 'Breast Unit, Mayday University Hospital, Croydon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Skene', 'Affiliation': 'Department of Surgery, Institute of Cancer Research Clinical Trials and Statistics Unit, Royal Bournemouth Hospital, Bournemouth.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Laing', 'Affiliation': ""Department of Oncology, St Luke's Cancer Centre, Guildford, UK.""}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, The Royal Marsden NHS Foundation Trust, London & Sutton. Electronic address: Ian.smith@rmh.nhs.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp602']
2836,17071939,Randomised phase II study comparing topotecan/carboplatin administration for 5 versus 3 days in the treatment of extensive-stage small-cell lung cancer.,"BACKGROUND


Topotecan is an active drug in small-cell lung cancer (SCLC). In our previous study, a combination of topotecan with cisplatin was associated with a median overall survival of 7.6 or 8.7 months, depending on the duration of treatment. We have replaced cisplatin by carboplatin in this trial, with the objective of creating a more convenient schedule for our patients. Furthermore, we have also compared the standard 5-day schedule with an experimental 3-day schedule.
PATIENTS AND METHODS


A total of 100 patients with metastatic disease were included. Patients were randomly assigned to receive either topotecan 0.75 mg/m2, days 1-5, and carboplatin AUC 5, day 5 (arm A) or topotecan 1.25 mg/m2, days 1-3, and carboplatin AUC 5, day 3 (arm B). Six cycles were given at a 3-week interval.
RESULTS


A total of 91 patients were assessable for response. The response during therapy was 86.9% in arm A and 80.0% in arm B. Median survival in arm A was 11.8 months and in arm B 11.6 months (P=0.37).
CONCLUSIONS


The combination of topotecan and carboplatin is active in extensive-disease SCLC. Toxicity and median survival were comparable in both arms. Three days of treatment seems to be similar to the 5-day regimen.",2007,Toxicity and median survival were comparable in both arms.,"['extensive-stage small-cell lung cancer', 'small-cell lung cancer (SCLC', '100 patients with metastatic disease were included', '91 patients were assessable for response']","['topotecan and carboplatin', 'topotecan/carboplatin', 'topotecan 1.25 mg/m2, days 1-3, and carboplatin AUC', 'topotecan 0.75 mg/m2, days 1-5, and carboplatin AUC', 'topotecan with cisplatin', 'cisplatin by carboplatin']","['median overall survival', 'Toxicity and median survival', 'Median survival']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",100.0,0.163412,Toxicity and median survival were comparable in both arms.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Seifart', 'Affiliation': 'Hamm-Kliniken, Bad Soden Salmünster. Electronic address: dr.seifart@hamm-kliniken.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fink', 'Affiliation': 'Klinikum Nuernberg-Nord, Nuernberg.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'Department of Medical Biometry and Informatics, University of Marburg and Giessen, Marburg.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hans', 'Affiliation': 'Department of Medical Biometry and Informatics, Johanniterkrankenanstalten Oberhausen, Oberhausen.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Krankenhaus Luedenscheid, Leudenscheid.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Koschel', 'Affiliation': 'AK Hamburg-Harburg, Hamburg.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schroeder', 'Affiliation': 'St Johannes Hospital, Duisburg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': 'Vogtlandklinikum, Plauen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dethling', 'Affiliation': 'Glaxo Smith Kline, Munich.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Department of Haematology and Oncology, Klinikum Kassel, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdl353']
2837,20089558,Low body mass index and sarcopenia associated with dose-limiting toxicity of sorafenib in patients with renal cell carcinoma.,"BACKGROUND


Patients with severe depletion of skeletal muscle (sarcopenia) are prone to dose-limiting toxicity (DLT) during fluoropyrimidine therapy. We hypothesized that sarcopenia may also predict toxicity of targeted therapy drugs.
MATERIALS AND METHODS


Metastatic renal cell cancer (RCC) patients (n = 55) received sorafenib 400 mg b.i.d. Weight, height and skeletal muscle cross-sectional area at the third lumbar vertebra were measured by computed tomography (CT). Toxicity was assessed.
RESULTS


DLT occurred in 22% of patients overall, of which three-quarters were dose reductions to 400 mg and the remainder entailed termination of treatment. DLT was most common (41%) in sarcopenic patients whose body mass index (BMI) was <25 kg/m(2) and least common (13%) in patients who were not sarcopenic and/or overweight or obese (P = 0.03). Toxicity was especially prevalent in sarcopenic male patients with BMI < 25, with 71% of men with these characteristics being unable to continue treatment at 800 mg/day. By contrast, only 5% of male patients whose muscle index was above the cut-off for sarcopenia and only 11% of male patients whose BMI was >25 experienced a DLT.
CONCLUSION


BMI < 25 kg/m(2) with diminished muscle mass is a significant predictor of toxicity in metastatic RCC patients treated with sorafenib.",2010,"RESULTS


DLT occurred in 22% of patients overall, of which three-quarters were dose reductions to 400 mg and the remainder entailed termination of treatment.","['Metastatic renal cell cancer', 'patients with renal cell carcinoma', 'Patients with severe depletion of skeletal muscle (sarcopenia', 'sarcopenic male patients with BMI < 25, with 71% of men']","['fluoropyrimidine therapy', 'sorafenib', 'sorafenib 400 mg b.i.d']","['toxicity', 'muscle index', 'Weight, height and skeletal muscle cross-sectional area at the third lumbar vertebra', 'BMI', 'Toxicity']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0223522', 'cui_str': 'Bone structure of L3 (body structure)'}]",,0.0397462,"RESULTS


DLT occurred in 22% of patients overall, of which three-quarters were dose reductions to 400 mg and the remainder entailed termination of treatment.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Antoun', 'Affiliation': 'Department of Supportive Care, Institut Gustave Roussy, Villejuif, France. Electronic address: sami.antoun@igr.fr.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Baracos', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Birdsell', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Sawyer', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp605']
2838,17047001,"Dose-dense adjuvant chemotherapy in node-positive breast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weeks. AERO B03 randomized phase II study.","BACKGROUND


Adding a taxane to anthracycline-based adjuvant chemotherapy prolongs survival in node-positive patients but optimal dose and schedule remain undetermined. This study aimed to select a dose-dense regimen for further assessment in phase III studies.
PATIENTS AND METHODS


Ninety-nine patients with node-positive invasive breast adenocarcinoma were randomly assigned to docetaxel (Taxotere) (T) 75 mg/m2, epirubicin (E) 75 mg/m2 and cyclophosphamide (C) 500 mg/m2 (TEC)x6, every 3 weeks; E 100 mg/m2, C 600 mg/m2 x 4, then T 100 mg/m2 x 4 (EC-->T) or the reverse sequence (T-->EC), every 2 weeks, with pegfilgrastim support. The primary end point was the incidence of grade 4 toxicity.
RESULTS


Dose intensity was almost doubled with dose-dense regimens, compared with TEC. Twenty-seven patients experienced grade 4 toxicity: 26%, 40% and 18% with TEC, EC-->T and T-->EC, respectively, mainly neutropenia, but febrile neutropenia occurred only in 11%, 10% and 3%. Grade 3-4 nail disorders, hand-foot syndrome and peripheral neuropathy occurred in 46%, 73% and 68% of patients with TEC, EC-->T and T-->EC, respectively.
CONCLUSIONS


Dose-dense regimens yield more frequent and severe nonhematological toxic effects than standard dose TEC regimen. Though grade 4 toxicity rates appear acceptable with the T-->EC regimen, the incidence of grade 3-4 events makes it difficult to recommend either dose-dense regimen for further investigation.",2007,"Twenty-seven patients experienced grade 4 toxicity: 26%, 40% and 18% with TEC, EC-->T and T-->EC, respectively, mainly neutropenia, but febrile neutropenia occurred only in 11%, 10% and 3%.","['Ninety-nine patients with node-positive invasive breast adenocarcinoma', 'node-positive breast cancer']","['taxane to anthracycline-based adjuvant chemotherapy', 'docetaxel followed by epirubicin/cyclophosphamide (T/EC', 'cyclophosphamide ', 'AERO', 'docetaxel, epirubicin and cyclophosphamide (TEC', 'docetaxel (Taxotere) (T) 75 mg/m2, epirubicin']","['febrile neutropenia', 'severe nonhematological toxic effects', 'Grade 3-4 nail disorders, hand-foot syndrome and peripheral neuropathy', 'incidence of grade 4 toxicity', 'grade 4 toxicity']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0858252', 'cui_str': 'Breast adenocarcinoma'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027339', 'cui_str': 'Nail Diseases'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",99.0,0.0481301,"Twenty-seven patients experienced grade 4 toxicity: 26%, 40% and 18% with TEC, EC-->T and T-->EC, respectively, mainly neutropenia, but febrile neutropenia occurred only in 11%, 10% and 3%.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Piedbois', 'Affiliation': 'Hôpital Henri-Mondor, Créteil. Electronic address: pascal.piedbois@hmn.aphp.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Serin', 'Affiliation': 'Institut Sainte-Catherine, Avignon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Priou', 'Affiliation': 'Hôpital départemental, La Roche-sur-Yon.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Laplaige', 'Affiliation': 'Clinique Saint-Come et Saint-Damien, Blois.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greget', 'Affiliation': 'Clinique Sainte-Clotilde, Saint-Louis de la Réunion.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Angellier', 'Affiliation': 'Hôpital Fontenoy, Chartres.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Teissier', 'Affiliation': 'Clinique Plein Ciel, Mougins.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Berdah', 'Affiliation': ""Clinique de l'Espérance, Hyères.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fabbro', 'Affiliation': ""CRLCC Val d'Aurelle, Montpellier.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Valenza', 'Affiliation': 'Centre Hospitalier, Draguignan, France, for the European Association for Research in Oncology.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herait', 'Affiliation': 'Soisy-sous-Montmorency.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jehl', 'Affiliation': 'International Drug Development Institute, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdl355']
2839,20110289,Management of isolated nonresectable liver metastases in colorectal cancer patients: a case-control study of isolated hepatic perfusion with melphalan versus systemic chemotherapy.,"BACKGROUND


To compare the median overall survival of patients with isolated nonresectable liver metastases in comparable groups of patients treated with either isolated hepatic perfusion (IHP) with melphalan or systemic chemotherapy.
PATIENTS AND METHODS


Colorectal cancer patients with isolated liver metastases, who underwent IHP, were included in this study. The control group consisted of a subgroup of colorectal cancer patients with liver metastases only, who were enrolled in the randomized CApecitabine, IRinotecan, Oxaliplatin (CAIRO) phase III study.
RESULTS


Ninety-nine patients were treated with IHP, and 111 patients were included in the control group. All patient characteristics were comparable except for age. Median follow-up was 78.1 months for IHP versus 54.7 months in the control group. Median overall survival was 25.0 [95% confidence interval (CI) 19.4-30.6] months for IHP and 21.7 (95% CI 19.6-23.8) months for systemic treatment and did not differ significantly (P = 0.29). Treatment-related mortality was 2% for the systemic treatment and 6% for IHP (P = 0.11).
CONCLUSION


Compared with a patient group with comparable characteristics treated with systemic chemotherapy, IHP does not provide a benefit in overall survival in patients with isolated nonresectable colorectal liver metastases. Currently, the use of IHP cannot be advocated outside the scope of clinical studies.",2010,"Treatment-related mortality was 2% for the systemic treatment and 6% for IHP (P = 0.11).
","['Ninety-nine patients were treated with IHP, and 111 patients were included in the control group', 'colorectal cancer patients with liver metastases only, who were enrolled in the randomized', 'patients with isolated nonresectable colorectal liver metastases', 'patients with isolated nonresectable liver metastases', 'Colorectal cancer patients with isolated liver metastases, who underwent IHP, were included in this study', 'colorectal cancer patients']","['melphalan versus systemic chemotherapy', 'isolated hepatic perfusion (IHP) with melphalan or systemic chemotherapy', 'systemic chemotherapy, IHP', 'CApecitabine, IRinotecan, Oxaliplatin (CAIRO']","['Treatment-related mortality', 'median overall survival', 'overall survival', 'Median overall survival']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.15255,"Treatment-related mortality was 2% for the systemic treatment and 6% for IHP (P = 0.11).
","[{'ForeName': 'L B J', 'Initials': 'LBJ', 'LastName': 'van Iersel', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mol', 'Affiliation': 'Comprehensive Cancer Centre East (IKO), Nijmegen.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'van Persijn van Meerten', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Hartgrink', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden.'}, {'ForeName': 'P J K', 'Initials': 'PJK', 'LastName': 'Kuppen', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Vahrmeijer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'R A E M', 'Initials': 'RAEM', 'LastName': 'Tollenaar', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Center, Leiden. Electronic address: a.j.gelderblom@lumc.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp589']
2840,31345387,Standard of care vs reduced-dose chemoradiation after induction chemotherapy in HPV+ oropharyngeal carcinoma patients: The Quarterback trial.,"BACKGROUND


Human Papillomavirus oropharyngeal carcinoma (HPVOPC) has better progression free (PFS) and overall survival (OS) than non-HPVOPC. Standard-dose chemoradiotherapy (sdCRT) results in significant acute toxicity and late morbidity. We hypothesized that after induction chemotherapy (IC), reduced dose chemoradiation (rdCRT) would result in equivalent PFS and OS compared to sdCRT plus IC in HPVOPC and would reduce toxicity.
METHODS


Patients with p16+, previously untreated, locally advanced HPVOPC and ≤20 pack years smoking history received 3 cycles of IC with docetaxel, cisplatin and fluorouracil (TPF). Clinical responders who were HPV positive by type-specific PCR were randomized 1:2 to sdCRT (7000 cGy) or rdCRT (5600 cGy) with weekly carboplatin. The endpoints of the study were 3 year PFS and OS.
RESULTS


23 patients were enrolled, 22 were evaluable for TPF toxicity and 20 were randomized, 8 to sdCRT and 12 to rdCRT. Sixteen (80%) were HPV 16+ and 4 (20%) were other high risk (HR) variants. Fourteen (70%) had high risk features: T4, N2c, or N3. Median follow up was 56 months (range 42-70). Three-year PFS/OS for sdCRT and rdCRT are 87.5% vs 83.3% (log-rank test p = 0.85), respectively. All 3 failures are locoregional within 4 months of completion of CRT; 2 were in HR variants (50%).
CONCLUSIONS


rdCRT after IC resulted in similar PFS/OS compared sdCRT. These data support Phase 3 clinical trials of radiation dose reduction after IC as a treatment strategy in HPVOPC. Molecular HPV with variant testing and smoking history are necessary for de-escalation trials.",2019,"Three-year PFS/OS for sdCRT and rdCRT are 87.5% vs 83.3% (log-rank test p = 0.85), respectively.","['23 patients were enrolled, 22 were evaluable for TPF toxicity and 20 were randomized, 8 to sdCRT and 12 to rdCRT', 'Human Papillomavirus oropharyngeal carcinoma (HPVOPC', '≤20 pack years', 'HPV+ oropharyngeal carcinoma patients', 'Patients with p16', 'Clinical responders who were HPV positive by type-specific PCR']","['rdCRT', 'induction chemotherapy (IC), reduced dose chemoradiation (rdCRT', 'carboplatin', 'sdCRT', 'care vs reduced-dose chemoradiation after induction chemotherapy', 'IC with docetaxel, cisplatin and fluorouracil (TPF', 'Standard-dose chemoradiotherapy (sdCRT']","['progression free (PFS) and overall survival (OS', 'acute toxicity and late morbidity', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0249880', 'cui_str': 'Cyclin-Dependent Kinase Inhibitor p16'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.236524,"Three-year PFS/OS for sdCRT and rdCRT are 87.5% vs 83.3% (log-rank test p = 0.85), respectively.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Misiukiewicz', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; The Departments of Hematology/Oncology in the Icahn School of Medicine at Mount Sinai, USA; Medicine in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Radiation Oncology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Miles', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; Otolaryngology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bakst', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; Radiation Oncology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Genden', 'Affiliation': 'Otolaryngology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Selkridge', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Surgeon', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rainey', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Camille', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roy', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Pathology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Pathology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; Biostatistics in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Moshier', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; Biostatistics in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bonomi', 'Affiliation': 'The Departments of Hematology/Oncology in the Icahn School of Medicine at Mount Sinai, USA; Medicine in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hwang', 'Affiliation': 'Medicine in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Som', 'Affiliation': 'Radiology in the Icahn School of Medicine at Mount Sinai, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Posner', 'Affiliation': 'The Tisch Cancer Institute in the Icahn School of Medicine at Mount Sinai, USA; The Departments of Hematology/Oncology in the Icahn School of Medicine at Mount Sinai, USA; Medicine in the Icahn School of Medicine at Mount Sinai, USA. Electronic address: marshall.posner@mssm.edu.'}]",Oral oncology,['10.1016/j.oraloncology.2019.06.021']
2841,31976311,Intestinal Microbiome Changes in Fecal Microbiota Transplant (FMT)  vs.  FMT Enriched with  Lactobacillus  in the Treatment of Recurrent  Clostridioides difficile  Infection.,"Aim


In this study, we conducted a comparative study to explore the differences in therapeutic efficacy and intestinal microbiome of fecal microbiota transplant (FMT)  vs.  FMT in addition with  Lactobacillus  (FMT-L) for treatment of recurrent  Clostridioides difficile  infection (R-CDI).
Methods


We designed a double-blinded randomized comparative two-arm pilot multicenter study to assess the efficacy and impact in the intestinal microbiome of standard capsules of FMT  vs.  FMT-L enriched with 3 species of  Lactobacillus  for patients with R-CDI. A 90-day follow-up of 21 patients was performed, starting at the beginning of the study. From the selected patients, fecal samples were obtained at days 0, 3, 7, and 28 after treatment. Fecal samples and FMT were analyzed by 16S rRNA sequencing.
Results


We included 21 patients (13 in the FMT group and 8 in the FMT-L group). Overall, both groups had a reduction in bowel movements per day, from 8.6 to 3.2 in the first 48 h (62.7% reduction,  p =0.001). No severe adverse reactions or recurrences were recorded. Firmicutes were the most abundant phylum in donors. A low relative abundance of Proteobacteria was detected and mostly found in patients even at higher proportions than the donor. The donor's pool also had relatively few Bacteroidetes, and some patients showed a higher abundance of this phylum. Based on the ANOSIM  R  values, there is a significant difference between the microbial communities of basal samples and samples collected on day 7 ( p =0.045) and at day 28 (0.041).
Conclusion


Fecal microbiota transplant by capsules was clinically and genomically similar between traditional FMT and enriched FMT with  Lactobacillus  spp. Restoration of bacterial diversity and resolution of dysbiosis at days 7 and 28 were observed. Patients with a first episode of recurrence treated with FMT had an excellent response without severe adverse events; FMT should be considered as an early treatment during R-CDI.",2019,"Overall, both groups had a reduction in bowel movements per day, from 8.6 to 3.2 in the first 48 h (62.7% reduction,  p =0.001).","['21 patients (13 in the FMT group and 8 in the FMT-L group', 'patients with R-CDI']","['FMT  vs.  FMT-L', 'FMT', 'fecal microbiota transplant (FMT)  vs.  FMT']","['Fecal samples and FMT', 'Restoration of bacterial diversity and resolution of dysbiosis', 'bowel movements', 'severe adverse reactions or recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",21.0,0.0621203,"Overall, both groups had a reduction in bowel movements per day, from 8.6 to 3.2 in the first 48 h (62.7% reduction,  p =0.001).","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Garza-González', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Mendoza-Olazarán', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Rayo', 'Initials': 'R', 'LastName': 'Morfin-Otero', 'Affiliation': 'Universidad de Guadalajara, Hospital Civil de Guadalajara Fray Antonio Alcalde e Instituto de Patología Infecciosa y Experimental, Centro Universitario de Ciencias de la Salud, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ramírez-Fontes', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rodríguez-Zulueta', 'Affiliation': 'Infectious Diseases Service, Hospital General Manuel Gea González, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Flores-Treviño', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Bocanegra-Ibarias', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Maldonado-Garza', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Camacho-Ortiz', 'Affiliation': 'Universidad Autónoma de Nuevo León, Facultad de Medicina, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Nuevo León, Mexico.'}]",Canadian journal of gastroenterology & hepatology,['10.1155/2019/4549298']
2842,32006422,"The Impact of High Dietary Sodium Consumption on Blood Pressure Variability in Healthy, Young Adults.","BACKGROUND


High sodium (Na+) intake augments blood pressure variability (BPV) in normotensive rodents, without changes in resting blood pressure (BP). Augmented BPV is associated with end-organ damage and cardiovascular morbidity. It is unknown if changes in dietary Na+ influence BPV in humans. We tested the hypothesis that high Na+ feeding would augment BPV in healthy adults.
METHODS


Twenty-one participants (10 F/11 M; 26 ± 5 years; BP: 113 ± 11/62 ± 7 mm Hg) underwent a randomized, controlled feeding study that consisted of 10 days of low (2.6 g/day), medium (6.0 g/day), and high (18.0 g/day) salt diets. On the ninth day of each diet, 24-h urine samples were collected and BPV was calculated from 24-h ambulatory BP monitoring. On the tenth day, in-laboratory beat-to-beat BPV was calculated during 10 min of rest. Serum electrolytes were assessed. We calculated average real variability (ARV) and standard deviation (SD) as metrics of BPV. As a secondary analysis, we calculated central BPV from the 24-h ambulatory BP monitoring.
RESULTS


24-h urinary Na+ excretion (low = 41 ± 24, medium = 97 ± 43, high = 265 ± 92 mmol/24 h, P < 0.01) and serum Na+ (low = 140.0 ± 2.1, medium = 140.7 ± 2.7, high = 141.7 ± 2.5 mmol/l, P = 0.009) increased with greater salt intake. 24-h ambulatory ARV (systolic BP ARV: low = 9.5 ± 1.7, medium = 9.5 ± 1.2, high = 10.0 ± 1.9 mm Hg, P = 0.37) and beat-to-beat ARV (systolic BP ARV: low = 2.1 ± 0.6, medium = 2.0 ± 0.4, high = 2.2 ± 0.8 mm Hg, P = 0.46) were not different. 24-h ambulatory SD (systolic BP: P = 0.29) and beat-to-beat SD (systolic BP: P = 0.47) were not different. There was a trend for a main effect of the diet (P = 0.08) for 24-h ambulatory central systolic BPV.
CONCLUSIONS


Ten days of high sodium feeding does not augment peripheral BPV in healthy, adults.
CLINICAL TRIALS REGISTRATION


NCT02881515.",2020,"There was a trend for a main effect of the diet (P=0.08) for 24-hour ambulatory central systolic BPV.
","['normotensive rodents', 'Healthy, Young Adults', 'healthy adults', 'humans', 'Twenty-one participants (10F/11M; 26±5 years; BP:113±11/62±7 mmHg', 'healthy, adults']","['High sodium (Na+) intake', 'High Dietary Sodium Consumption', 'Na+ feeding']","['resting blood pressure (BP', 'peripheral BPV', '24-hour ambulatory ARV (systolic BP ARV', 'Serum electrolytes', 'Blood Pressure Variability', 'blood pressure variability (BPV', '24-hour ambulatory SD (systolic BP: P=0.29) and beat-to-beat SD (systolic BP', '24-hour ambulatory central systolic BPV', 'serum Na', '24-hour urinary Na+ excretion', 'beat-to-beat ARV (systolic BP ARV', 'average real variability (ARV) and standard deviation (SD) as metrics of BPV']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",21.0,0.0346906,"There was a trend for a main effect of the diet (P=0.08) for 24-hour ambulatory central systolic BPV.
","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, Division of Renal-Electrolyte, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, Delaware, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa014']
2843,31929980,A Randomized Placebo-Controlled  N -of-1 Trial: The Effect of Proton Pump Inhibitor in the Management of Gastroesophageal Reflux Disease.,"Background


Gastroesophageal reflux disease (GERD) is the most frequent chronic gastrointestinal disorder. It is defined as a condition developed when the reflux of gastric contents causes troublesome symptoms (heartburn and regurgitation). This requires adequate treatment since it can lead to long-term complications including esophagus adenocarcinoma. Proton pump inhibitors (PPI) are generally used to treat GERD due to their high-security profile and efficiency on most patients. However, recurrent reflux despite initial treatment is frequent.  N -of-1 trial is a study that allows the identification of the best treatment for each patient. The objective of this study is to compare the efficacy of standard dose with double dosage of esomeprazole, to improve the GERD symptoms in a single patient.
Methods


A single-patient trial, placebo-controlled, randomized, double-blind, was carried out from September 25th, 2012, to April 26th, 2013. It included one outpatient at the gastroenterology service in a fourth-level hospital, diagnosed with nonerosive reflux disease (NERD). Yet, his symptoms were heartburn and reflux, and his endoscopic results were normal esophageal mucosa, without hiatal hernia, though pathological pH values. A no-obese male without any tobacco or alcohol usage received esomeprazole 40 mg/day and 40 mg/bid for 24 weeks. A standardized gastroesophageal reflux disease questionnaire (GerdQ) was used weekly to evaluate symptom frequency and severity. The consumption of 90% of the capsules was considered as an adequate treatment adherence. D'agostino-Pearson and Wilcoxon test were used to determine normal or nonnormal distribution and compare both treatments, respectively, both with a significant statistical difference of  p  < 0.05.
Results


The patient completed the study with 96% of adherence. The double dosage of esomeprazole did not improve the control of symptoms compared with the standard dosage. Mean symptomatic score was 9.5±0.5 and 10.2±0.6 for each treatment, respectively ( p  > 0.05).
Conclusion


There was no significant improvement in the patient GERD symptoms increasing the dose of oral esomeprazole during the 6 months of study.  N -of-1 trials in chronic pathologies including GERD are recommended due to their potential value as systematic methods that evaluate therapies without strong scientific evidence.",2019,There was no significant improvement in the patient GERD symptoms increasing the dose of oral esomeprazole during the 6 months of study.  ,"['Controlled  N -of-1 Trial', 'It included one outpatient at the gastroenterology service in a fourth-level hospital, diagnosed with nonerosive reflux disease (NERD', 'Gastroesophageal Reflux Disease']","['Placebo', 'Proton Pump Inhibitor', 'placebo', 'esomeprazole', 'Proton pump inhibitors (PPI']","['Mean symptomatic score', 'standardized gastroesophageal reflux disease questionnaire (GerdQ', 'control of symptoms', 'patient GERD symptoms', 'GERD symptoms']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0587581', 'cui_str': 'Gastroenterology service (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.180728,There was no significant improvement in the patient GERD symptoms increasing the dose of oral esomeprazole during the 6 months of study.  ,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Sierra-Arango', 'Affiliation': 'Gastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, Colombia.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Castaño', 'Affiliation': 'Gastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, Colombia.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Forero', 'Affiliation': 'Gastroenterology and Hepatology Department, Fundación Santa Fe de Bogotá, School of Medicine, Universidad de los Andes, Bogotá, Colombia.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Pérez-Riveros', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Ardila Duarte', 'Affiliation': 'Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Botero', 'Affiliation': 'Pathology Department, Hospital Universitari Vall de Hebron, Barcelona, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cárdenas', 'Affiliation': 'GI/Endoscopy Unit, Institut de Malalties Digestives Metaboliques, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'De la Hoz-Valle', 'Affiliation': 'Head of Subdirección de Estudios Clínicos y Epidemiología Clínica (SECEC), Fundación Santa Fe de Bogotá, Bogotá, Colombia.'}]",Canadian journal of gastroenterology & hepatology,['10.1155/2019/3926051']
2844,31989151,Network Analysis Indicates That Avolition Is the Most Central Domain for the Successful Treatment of Negative Symptoms: Evidence From the Roluperidone Randomized Clinical Trial.,"A recent conceptual development in schizophrenia is to view its manifestations as interactive networks rather than individual symptoms. Negative symptoms, which are associated with poor functional outcome and reduced rates of recovery, represent a critical need in schizophrenia therapeutics. MIN101 (roluperidone), a compound in development, demonstrated efficacy in the treatment of negative symptoms in schizophrenia. However, it is unclear how the drug achieved its effect from a network perspective. The current study evaluated the efficacy of roluperidone from a network perspective. In this randomized clinical trial, participants with schizophrenia and moderate to severe negative symptoms were randomly assigned to roluperidone 32 mg (n = 78), 64 mg (n = 83), or placebo (N = 83). Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms. Microscopic properties were evaluated to examine which individual symptoms were most influential (ie, interconnected) on other symptoms in the network and are responsible for successful treatment effects. Participants receiving roluperidone did not differ from those randomized to placebo on macroscopic properties. However, microscopic properties (degree and closeness centrality) indicated that avolition was highly central in patients receiving placebo and that roluperidone reduced this level of centrality. These findings suggest that decoupling the influence of motivational processes from other negative symptom domains is essential for producing global improvements. The search for pathophysiological mechanisms and targeted treatment development should be focused on avolition, with the expectation of improvement in the entire constellation of negative symptoms if avolition is effectively treated.",2020,Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms.,['participants with schizophrenia and moderate to severe negative symptoms'],"['MIN101 (roluperidone', 'placebo', 'roluperidone']",[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.241904,Macroscopic network properties were evaluated to determine whether roluperidone altered the overall density of the interconnections among symptoms.,"[{'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Zamani Esfahlani', 'Affiliation': 'Department of Systems Science and Industrial Engineering & Center for Collective Dynamics of Complex Systems, Binghamton University, Binghamton, NY.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sayama', 'Affiliation': 'Department of Systems Science and Industrial Engineering & Center for Collective Dynamics of Complex Systems, Binghamton University, Binghamton, NY.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Reno School of Medicine, University of Nevada, Reno, NV.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Opler', 'Affiliation': 'MedAvante-ProPhase, New York, NY.'}, {'ForeName': 'Jay B', 'Initials': 'JB', 'LastName': 'Saoud', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Luthringer', 'Affiliation': 'Minerva Neurosciences, Waltham, MA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbz141']
2845,32000140,Vertical Versus Horizontal Resisted Sprint Training Applied to Young Soccer Players: Effects on Physical Performance,"PURPOSE


To analyze and compare the effects of 4 different resisted sprint training (RST) modalities on youth soccer players' performance after 8 weeks of training.
METHODS


Forty-eight youth soccer players were first randomly assigned to 4 groups and only then completed 8 weeks of RST: horizontal resisted sprint, vertical resisted sprint (VRS), combined resisted sprint, and unresisted sprint. Performance in horizontal and vertical jumps, sprint, and change of direction (COD) ability were assessed 1 week before and after the training intervention. Magnitude-based inference analysis was performed for calculating within-group pre-post differences. In addition, an analysis of covariance test was performed for between-group comparison, using the pretest values as covariates. After that, the analysis of covariance P values and the effect statistic were transformed to magnitude-based inference.
RESULTS


Within-group outcomes showed that all resisted training modalities experienced improvements in sprint (small to moderate) and COD (small to large) performance. Moreover, all groups, except unresisted sprint, enhanced the horizontal jump performance. However, only VRS improved on vertical jump. Between-group comparison outcomes revealed that only VRS improved the sprint time compared with horizontal resisted sprint (moderate) and COD performance compared with all groups (moderate to large). In addition, VRS enhanced the countermovement jump performance (small to large) compared with the other groups.
CONCLUSIONS


Independent of the orientation of the resistance applied, RST is an effective training method for improving sprinting and COD performance. Nevertheless, VRS may promote greater improvements on sprint and COD ability and have a positive additional effect on countermovement jump performance and the reduction of COD deficit.",2020,"Independent of the orientation of the resistance applied, RST is an effective training method for improving sprinting and COD performance.","['Young Soccer Players', ""youth soccer players' performance after 8 weeks of training"", 'Forty-eight youth soccer players']","['VRS', 'resisted sprint training (RST) modalities', 'Vertical Versus Horizontal Resisted Sprint Training', 'RST: horizontal resisted sprint, vertical resisted sprint (VRS), combined resisted sprint, and unresisted sprint']","['sprint (small to moderate) and COD (small to large) performance', 'VRS improved on vertical jump', 'COD deficit', 'Performance in horizontal and vertical jumps, sprint, and change of direction (COD) ability', 'sprint and COD ability', 'sprint time compared with horizontal resisted sprint (moderate) and COD performance', 'horizontal jump performance', 'sprinting and COD performance', 'countermovement jump performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]",48.0,0.0218241,"Independent of the orientation of the resistance applied, RST is an effective training method for improving sprinting and COD performance.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carlos-Vivas', 'Affiliation': ''}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perez-Gomez', 'Affiliation': ''}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Eriksrud', 'Affiliation': ''}, {'ForeName': 'Tomás T', 'Initials': 'TT', 'LastName': 'Freitas', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marín-Cascales', 'Affiliation': ''}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Alcaraz', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0355']
2846,30791040,Associations of measures of systemic blood flow used in a randomized trial of delayed cord clamping in preterm infants.,"OBJECTIVE


To determine associations of low superior vena cava (SVC) flow (≤55 ml/kg/min) and low right ventricular output (RVO) (≤150 ml/kg/min) in preterm infants.
DESIGN/METHODS


An observational study in infants <30 weeks gestation randomized to receive immediate (<10 s) or delayed cord clamping (DCC) (≥60 s).
RESULTS


The study enrolled 265 infants with a mean (SD) gestation 28 (2) weeks. Eighty-six (33%) infants had low SVC flow and 81 (31%) infants had low RVO. In multivariate analysis, low SVC flow was associated with gestation; low RVO was associated with DCC, gender and 5-minute Apgar; whereas mean RVO was negatively associated with both FiO 2  and mean airway pressure (MAP) at 9 h and 24 h. Low SVC flow was associated with ductus arteriosus (DA) treatment. Infants with low RVO had higher mortality on univariate analysis, but this was not significant after adjusting for gestation.
CONCLUSIONS


SVC flow was associated with gestation, whilst RVO was associated with placental transfusion, gender, condition at birth, and early respiratory adaptation. Compared to infants with normal values, more infants with low SVC flow were treated for DA, but infants with low RVO had no significant difference in mortality or morbidity.",2019,"In multivariate analysis, low SVC flow was associated with gestation; low RVO was associated with DCC, gender and 5-minute Apgar; whereas mean RVO was negatively associated with both FiO 2  and mean airway pressure (MAP) at 9 h and 24 h. Low SVC flow was associated with ductus arteriosus (DA) treatment.","['preterm infants', 'An observational study in infants <30 weeks gestation randomized to', '265 infants with a mean (SD) gestation 28 (2) weeks']","['low superior vena cava (SVC) flow (≤55\u2009ml/kg/min) and low right ventricular output (RVO', 'receive immediate (<10\u2009s) or delayed cord clamping (DCC) (≥60\u2009s', 'delayed cord clamping']","['FiO 2  and mean airway pressure (MAP', 'mean RVO', 'low RVO', 'mortality or morbidity', 'low SVC flow']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0456961', 'cui_str': 'Low superior vena cava (body structure)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",265.0,0.149922,"In multivariate analysis, low SVC flow was associated with gestation; low RVO was associated with DCC, gender and 5-minute Apgar; whereas mean RVO was negatively associated with both FiO 2  and mean airway pressure (MAP) at 9 h and 24 h. Low SVC flow was associated with ductus arteriosus (DA) treatment.","[{'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Popat', 'Affiliation': ""Children's Hospital at Westmead, Westmead, NSW, Australia. himanshu.popat@health.nsw.gov.au.""}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Sebastian', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Centre for Neonatal Education and Research, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sinhal', 'Affiliation': 'Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Koert', 'Initials': 'K', 'LastName': 'de Waal', 'Affiliation': ""John Hunter Children's Hospital, New Lambton, NSW, Australia.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}]",Pediatric research,['10.1038/s41390-019-0348-1']
2847,32003647,Eccentric and Isometric Exercises in Achilles Tendinopathy Evaluated by the VISA-A Score and Shear Wave Elastography.,"BACKGROUND


Apart from eccentric exercises (EE), isometric exercises (ISO) might be a treatment option for Achilles tendinopathy. Shear wave elastography (SWE) provides information for diagnosis and for monitoring tissue elasticity, which is altered in symptomatic tendons.
HYPOTHESIS


Isometric exercises will have a beneficial effect on patients' outcome scores. Based on SWE, insertional and midportion tendon parts will differ in their elastic properties according to current symptoms.
STUDY DESIGN


Randomized clinical trial.
LEVEL OF EVIDENCE


Level 2.
METHODS


Group 1 (EE; n = 20; 12 males, 8 females; mean age, 52 ± 8.98 years) and group 2 (EE + ISO; n = 22; 15 males, 7 females; mean age, 47 ± 15.11 years) performed exercises for 3 months. Measurement points were before exercises were initiated as well as after 1 and 3 months using the Victorian Institute of Sports Assessment-Achilles (VISA-A) score, American Orthopaedic Foot & Ankle Society score, and SWE (insertion and midportion).
RESULTS


Both groups improved significantly, but there were no significant interindividual differences (VISA-A;  P  = 0.362) between group 1 (n = 15; +15 VISA-A) and group 2 (n = 15; +15 VISA-A). The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa;  P  = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa;  P  = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons. The midportion location had significantly higher Young modulus than the insertional part of the tendon ( P  = 0.005).
CONCLUSION


Isometric exercises do not have additional benefit when combined with eccentric exercises, as assessed over a 3-month intervention period. SWE is able to distinguish between insertional and midportion tendon parts in a symptomatic and asymptomatic state.
CLINICAL RELEVANCE


The present study shows no additional effect of ISO when added to baseline EE in treating Achilles tendinopathy. Different elastic properties of the insertional and midportion tendon have to be taken into consideration when rating a tendon as pathologic.",2020,"The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa;  P  = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa;  P  = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons.","['Group 1 (EE; n = 20; 12 males, 8 females; mean age, 52 ± 8.98 years) and group 2 (EE + ISO; n = 22; 15 males, 7 females; mean age, 47 ± 15.11 years', 'Achilles']","['SWE', 'Shear wave elastography (SWE', 'Victorian Institute of Sports Assessment-Achilles', 'Eccentric and Isometric Exercises', 'Isometric exercises', 'ISO', 'eccentric exercises (EE), isometric exercises (ISO']","['symptomatic midportion of the Achilles tendon', 'VISA-A Score and Shear Wave Elastography', 'VISA-A) score, American Orthopaedic Foot & Ankle Society score, and SWE (insertion and midportion']","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}]","[{'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0372102,"The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa;  P  = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa;  P  = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gatz', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Betsch', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Dirrichs', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schrading', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Tingart', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Michalik', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Quack', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}]",Sports health,['10.1177/1941738119893996']
2848,31914242,"Health Care Hotspotting - A Randomized, Controlled Trial.","BACKGROUND


There is widespread interest in programs aiming to reduce spending and improve health care quality among ""superutilizers,"" patients with very high use of health care services. The ""hotspotting"" program created by the Camden Coalition of Healthcare Providers (hereafter, the Coalition) has received national attention as a promising superutilizer intervention and has been expanded to cities around the country. In the months after hospital discharge, a team of nurses, social workers, and community health workers visits enrolled patients to coordinate outpatient care and link them with social services.
METHODS


We randomly assigned 800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care. The primary outcome was hospital readmission within 180 days after discharge.
RESULTS


The 180-day readmission rate was 62.3% in the intervention group and 61.7% in the control group. The adjusted between-group difference was not significant (0.82 percentage points; 95% confidence interval, -5.97 to 7.61). In contrast, a comparison of the intervention-group admissions during the 6 months before and after enrollment misleadingly suggested a 38-percentage-point decline in admissions related to the intervention because the comparison did not account for the similar decline in the control group.
CONCLUSIONS


In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care. (Funded by the National Institute on Aging and others; ClinicalTrials.gov number, NCT02090426; American Economic Association registry number, AEARCTR-0000329.).",2020,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","['patients with very high use of health care services', 'community health workers visits enrolled patients to coordinate outpatient care and link them with social services', ""800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care"", 'superutilizers,"" patients with very high use of health care services']","[""Coalition's program than among those who received usual care""]","['hospital readmission within 180 days after discharge', 'readmission rates', '180-day readmission rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",800.0,0.0828356,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Annetta', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}]",The New England journal of medicine,['10.1056/NEJMsa1906848']
2849,31679821,Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers.,"PURPOSE


The US Food and Drug Administration has approved several omega-3 (OM3)-containing prescription drugs for the treatment of severe hypertriglyceridemia (HTG). However, there is still a need to develop formulations with high bioavailability irrespective of the fat content and time of the meal. OM3-phospholipid (PL)/free fatty acid (FFA) is an investigational drug for the treatment of severe HTG containing naturally derived krill oil mixture of OM3, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as PL esters and as FFA. Both forms in OM3-PL/FFA are believed to be readily bioavailable. Per gram, OM3-PL/FFA contains a lower dose of EPA/DHA in comparison with already approved prescription drugs. The study aim was to evaluate OM3-PL/FFA pharmacokinetic (PK) properties after single and multiple oral doses of 1, 2, and 4 g in healthy subjects when receiving a Therapeutic Lifestyle Change (TLC) diet. The dose proportionality of the study drug, the effect of a high-fat (HF) meal on its PK properties and its safety profile after multiple administration were also explored.
METHODS


In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers following a TLC diet were randomly assigned into 1 of 3 treatment groups in a 1:1:1 ratio to receive a single dose at day 1, followed by multiple oral doses of 1, 2, and 4 g/d for 14 days. At day 15, all subjects received a HF breakfast.
FINDINGS


After once-daily dosing, based on graphic assessment, OM3-PL/FFA levels reached steady state within 7-10 days. Exposure of total EPA + DHA, total DHA, and total EPA (C max  and AUC) appeared to be approximately proportional over the 1-4 g/d dose range. After 14 days of repeated daily dosing, accumulation was observed and was greater at the higher dose of the study product. When administered after a HF breakfast on day 15, median t max , the geometric mean of AUC 0-24  and C max  were comparable with the values on day 14 across the 3 dose levels.
IMPLICATIONS


OM3-PL/FFA was found to be well tolerated in healthy subjects. The study drug PK properties appeared to be approximately dose proportional over the 1-4 g/d dose range. The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration. This is clinically relevant because a low-fat diet is part of the management of patients with HTG.",2019,The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.,"['42 healthy volunteers following a TLC diet', 'Healthy Volunteers', 'healthy subjects when receiving a Therapeutic Lifestyle Change (TLC) diet', 'patients with HTG', 'severe hypertriglyceridemia (HTG', 'healthy subjects']","['OM3-phospholipid (PL)/free fatty acid (FFA', 'high-fat (HF) meal', 'OM3-PL/FFA Pharmacokinetics', 'HF breakfast']","['bioavailability of OM3-PL/FFA', 'OM3-PL/FFA pharmacokinetic (PK) properties', 'total EPA\xa0+\xa0DHA, total DHA, and total EPA (C max  and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]","[{'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",42.0,0.0400967,The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.,"[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Lapointe', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada. Electronic address: j-f.lapointe@acastipharma.com.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}, {'ForeName': 'Sarya', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lemieux', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.003']
2850,32003520,Sleep coach intervention for teens with type 1 diabetes: Randomized pilot study.,"BACKGROUND


Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.
OBJECTIVE


To evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D.
RESEARCH DESIGN AND METHODS


Teens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents.
RESULTS


Feasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed.
CONCLUSIONS


The Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.",2020,"Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48 minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants.","['Teens aged 13-17 with T1D', 'teens with T1D', 'Teens with Type 1 Diabetes', 'Teens with type 1 diabetes (T1D) experience increased sleep disturbances']","['Sleep Coach Intervention', 'Usual Care', 'Sleep Coach intervention', 'sleep-promoting intervention', 'educational materials on healthy sleep habits and completed 3 individual telephone sessions']","['sleep duration and improved sleep quality', 'sleep quality', 'sleep efficiency and sleep duration', 'sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0236941,"Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48 minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hamburger', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bergner', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Rodayne', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}]",Pediatric diabetes,['10.1111/pedi.12991']
2851,31999946,"TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial.","BACKGROUND


TAS-102 (trifluridine-tipiracil) has shown a significant overall survival benefit compared with placebo in patients with chemorefractory metastatic colorectal cancer. Inspired by the encouraging results of a small phase 1-2 study, C-TASK FORCE, which evaluated the combination of TAS-102 plus bevacizumab in patients with chemorefractory metastatic colorectal cancer, we aimed to compare the efficacy of TAS-102 plus bevacizumab versus TAS-102 monotherapy in patients receiving refractory therapy for metastatic colorectal cancer .
METHODS


This investigator-initiated, open-label, randomised, phase 2 study enrolled patients (aged ≥18 years) with metastatic colorectal from four cancer centres in Denmark. The main inclusion criteria were histopathologically confirmed metastatic colorectal cancer refractory or intolerant to a fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab (only for RAS wild-type), and WHO performance status of 0 or 1. Previous therapy with bevacizumab, aflibercept, ramucirumab, or regorafenib was allowed but not mandatory. Participants were enrolled and randomly assigned (1:1) in block sizes of two, four, or six by a web-based tool to receive oral TAS-102 (35 mg/m 2  twice daily on days 1-5 and 8-12 every 28 days) alone or combined with intravenous bevacizumab (5 mg/kg on days 1 and 15) until progression, unacceptable toxicity, or patient decision to withdraw. Treatment assignment was not masked, and randomisation was stratified by institution and RAS mutation status. The primary endpoint was investigator-evaluated progression-free survival. All analyses were based on intention to treat. This trial is registered with EudraCT, 2016-005241-23.
FINDINGS


From Aug 24, 2017, to Oct 31, 2018, 93 patients were enrolled and randomly assigned to TAS-102 (n=47) or TAS-102 plus bevacizumab (n=46). The clinical cut-off date was Feb 15, 2019, after a median follow-up of 10·0 months (IQR 6·8-14·0). Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45 [95% CI 0·29-0·72]; p=0·0015). The most frequent grade 3 or worse adverse event was neutropenia (18 [38%] of 47 in the TAS-102 monotherapy group vs 31 [67%] of 46 in the TAS-102 plus bevacizumab group). Serious adverse events were observed in 21 (45%) patients in the TAS-102 group and 19 (41%) in the TAS-102 plus bevacizumab group. No deaths were deemed treatment related.
INTERPRETATION


In patients with chemorefractory metastatic colorectal cancer, TAS-102 plus bevacizumab, as compared with TAS-102 monotherapy, was associated with a significant and clinically relevant improvement in progression-free survival with tolerable toxicity. The combination of TAS-102 plus bevacizumab could be a new treatment option for patients with refractory metastatic colorectal cancer and could be a practice-changing development.
FUNDING


Servier.",2020,Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45,"['patients receiving refractory therapy for metastatic colorectal cancer ', 'From Aug 24, 2017, to Oct 31, 2018, 93 patients', 'patients with chemorefractory metastatic colorectal cancer', '2016-005241-23', 'patients with refractory metastatic colorectal cancer', 'enrolled patients (aged ≥18 years) with metastatic colorectal from four cancer centres in Denmark', 'only for RAS wild-type), and WHO performance status of 0 or 1']","['bevacizumab, aflibercept, ramucirumab, or regorafenib', 'oral TAS-102 (35 mg/m 2  twice daily on days 1-5 and 8-12 every 28 days) alone or combined with intravenous bevacizumab', 'TAS-102 with or without bevacizumab', 'fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab', 'placebo', 'TAS-102 plus bevacizumab', 'TAS-102 (trifluridine-tipiracil', 'TAS-102 monotherapy', 'TAS-102']","['Median progression-free survival', 'Serious adverse events', 'neutropenia', 'progression-free survival with tolerable toxicity', 'investigator-evaluated progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4055631', 'cui_str': 'tipiracil / Trifluridine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",93.0,0.304014,Median progression-free survival was 2·6 months (95% CI 1·6-3·5) in the TAS-102 group versus 4·6 months (3·5-6·5) in the TAS-102 plus bevacizumab group (hazard ratio 0·45,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: per.pfeiffer@rsyd.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Zitnjak', 'Affiliation': 'Department of Oncology, Hospital of Southern Jutland, Soenderborg, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Krogh', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lone Nørgård', 'Initials': 'LN', 'LastName': 'Petersen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Laurids Østergaard', 'Initials': 'LØ', 'LastName': 'Poulsen', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Stine Braendegaard', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Karina Gravgaard', 'Initials': 'KG', 'LastName': 'Thomsen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30827-7']
2852,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
2853,31995787,"The Effects of In-Season, Low-Volume Sprint Interval Training With and Without Sport-Specific Actions on the Physical Characteristics of Elite Academy Rugby League Players","PURPOSE


To determine the utility of running-only and rugby-specific, in-season sprint interval interventions in professional rugby league players.
METHODS


Thirty-one professional academy rugby players were assigned to a rugby-specific (SITr/s, n = 16) or running-only (SITr, n = 15) sprint interval training group. Measures of speed, power, change of direction ability, prone Yo-Yo Intermittent Recovery Test (Yo-Yo IR1) performance, and heart rate recovery were taken before and after the 2-week intervention as were submaximal responses to the prone Yo-Yo IR1. Internal, external, and perceptual responses were collected during SITr/s and SITr, with well-being and neuromuscular function assessed before each session.
RESULTS


Despite contrasting (possible to most likely) internal, external, and perceptual responses to the SIT interventions, possible to most likely within-group improvements in physical characteristics, heart rate recovery, and submaximal responses to the prone Yo-Yo IR1 were observed after both interventions. Between-group analysis favored the SITr/s intervention (trivial to moderate) for changes in 10-m sprint time, countermovement jump, change of direction, and medicine ball throw as well as submaximal (280-440 m) high metabolic power, PlayerLoad™, and acceleration distance during the prone Yo-Yo IR1. Overall changes in well-being or neuromuscular function were unclear.
CONCLUSIONS


Two weeks of SITr/s and SITr were effective for improving physical characteristics, heart rate recovery, and submaximal responses to the prone Yo-Yo IR1, with no clear change in well-being and neuromuscular function. Between-group analysis favored the SITr/s group, suggesting that the inclusion of sport-specific actions should be considered for in-season conditioning of rugby league players.",2020,"Between-group analysis favored the SITr/s intervention (trivial to moderate) for changes in 10-m sprint time, countermovement jump, change of direction, and medicine ball throw as well as submaximal (280-440 m) high metabolic power, PlayerLoad™, and acceleration distance during the prone Yo-Yo IR1.","['professional rugby league players', 'Elite Academy Rugby League Players', 'Thirty-one professional academy rugby players']","['rugby-specific (SITr/s, n = 16) or running-only (SITr, n = 15) sprint interval training group', 'Season, Low-Volume Sprint', 'running-only and rugby-specific, in-season sprint interval interventions', 'Interval Training With and Without Sport-Specific Actions']","['10-m sprint time, countermovement jump, change of direction, and medicine ball throw as well as submaximal (280-440\xa0m) high metabolic power, PlayerLoad™, and acceleration distance', 'physical characteristics, heart rate recovery, and submaximal responses', 'speed, power, change of direction ability, prone Yo-Yo Intermittent Recovery Test (Yo-Yo IR1) performance, and heart rate recovery']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}]","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0219589,"Between-group analysis favored the SITr/s intervention (trivial to moderate) for changes in 10-m sprint time, countermovement jump, change of direction, and medicine ball throw as well as submaximal (280-440 m) high metabolic power, PlayerLoad™, and acceleration distance during the prone Yo-Yo IR1.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Dobbin', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Highton', 'Affiliation': ''}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Twist', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0165']
2854,31996605,A Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People With Traumatic Brain Injury: Participant-Reported Communication Outcomes.,"OBJECTIVE


To investigate the efficacy of telehealth-based and in-person social communication skills training (TBIconneCT) for people with moderate to severe traumatic brain injury (TBI) based on outcomes reported by the survivor and a close communication partner.
SETTING


Australia. Two telehealth dyads were located outside Australia.
PARTICIPANTS


Adults (n = 51) at least 6 months after moderate-severe TBI with social communication skills deficits, and their usual communication partners (family members, friends, or paid carers).
DESIGN


Partially randomized controlled trial, with a telehealth intervention group, in-person intervention group, and a historical control group.
MAIN MEASURES


La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change). Both self- and other-reports.
RESULTS


Trained participants had significantly more items with perceived positive change than did historical controls. A medium effect size in the sample was observed for improvements in total score reported by trained communication partners after treatment. Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
CONCLUSIONS


Whether delivered via telehealth or in-person, social communication skills training led to perceived positive change in communication skills. It was unexpected that outcomes for the telehealth group were better than for the in-person group on some variables.",2020,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
","['People With Traumatic Brain Injury', 'Australia', 'people with moderate to severe traumatic brain injury (TBI', 'Adults (n = 51']","['historical control group', 'telehealth-based and in-person social communication skills training (TBIconneCT', 'telehealth intervention', 'Person Social Communication Skills Training']","['total score', 'La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.101985,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables.
","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Australia (Ms Rietdijk and Drs Power, Attard, Heard, and Togher); and Graduate School of Health, The University of Technology Sydney, Australia (Dr Power).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000554']
2855,30902791,Calcium and vitamin D supplementation and bone health in Marine recruits: Effect of season.,"Stress fractures are common overuse injuries caused by repetitive bone loading. These fractures are of particular concern for military recruits and athletes resulting in attrition in up to 60% of recruits that sustain a fracture. Army and Navy recruits supplemented with daily calcium and vitamin D (Ca + D) demonstrated improved bone strength and reduced stress fractures. The aim of the current study was to evaluate whether Ca + D supplementation improves measures of bone health in recruits undergoing United States Marine Corps initial military training (IMT), and whether the effect of supplementation on indices of bone health varied by season. One-hundred ninety-seven Marine recruits (n = 107 males, n = 90 females, mean age = 18.9 ± 1.6 y) were randomized to receive either Ca + D fortified snack bars (2000 mg Ca and 1000 IU vitamin D per day) or placebo divided into twice daily doses during 12 weeks of IMT. Anthropometrics, fasted blood samples, and peripheral quantitative computed tomography (pQCT) scans of the tibial metaphysis and diaphysis were collected upon entrance to- and post-training (12 weeks later). Half of the volunteers entered training in July and the other half started in February. Time-by-group interactions were observed for vitamin D status (25OHD) and the bone turnover markers, BAP, TRAP and OCN. 25OHD increased and BAP, TRAP and OCN all decreased in the Ca + D group (p < .05). Training increased distal tibia volumetric BMD (+1.9 ± 2.8%), BMC (+2.0 ± 3.1%), and bone strength index (BSI; +4.0 ± 4.0%) and diaphyseal BMC (+1.0 ± 2.2%) and polar stress strain index (SSIp; +0.7 ± 2.1%) independent of Ca + D supplementation (p < .05 for all). When analyzed by season, change in BSI was greater in the Ca + D group as compared to placebo in the summer iteration only (T*G; p < .05). No other effects of supplementation on bone tissue were observed. When categorized by tertile of percent change in BSI, recruits demonstrating the greatest changes in BSI and 25OHD entered training with the lowest levels of 25OHD (p < .05). Over all, these results suggest that Ca + D supplementation reduced some markers of bone formation and resorption and the decline in 25OHD over training in volunteers that started training in the summer was prevented by supplementation. Baseline 25OHD and trajectory may impact bone responses to IMT, but little effect of Ca + D supplementation was observed at the investigated doses.",2019,"25OHD increased and BAP, TRAP and OCN all decreased in the Ca + D group (p < .05).","['Marine recruits', 'One-hundred ninety-seven Marine recruits (n\u202f=\u202f107 males, n\u202f=\u202f90 females, mean age\u202f=\u202f18.9\u202f±\u202f1.6 y', 'recruits undergoing United States Marine Corps initial military training (IMT']","['daily calcium and vitamin D (Ca\u202f+\u202fD', 'placebo', 'Ca\u202f+\u202fD fortified snack bars (2000\u202fmg Ca and 1000\u202fIU vitamin D per day) or placebo', 'Calcium and vitamin D supplementation', 'Ca\u202f+\u202fD supplementation']","['polar stress strain index', 'bone tissue', 'diaphyseal BMC', 'bone strength and reduced stress fractures', 'distal tibia volumetric BMD', 'bone formation and resorption', '25OHD increased and BAP, TRAP and OCN', 'BSI', 'vitamin D status (25OHD) and the bone turnover markers, BAP, TRAP and OCN', 'bone health', 'Anthropometrics, fasted blood samples, and peripheral quantitative computed tomography (pQCT) scans of the tibial metaphysis and diaphysis', 'bone strength index', 'BMC']","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0391978', 'cui_str': 'Bone Tissue'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0016664', 'cui_str': 'Fractures, Fatigue'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia (body structure)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0908518', 'cui_str': '5-((76)Br)bromo-3-((2-azetidinyl)methoxy)pyridine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0222671', 'cui_str': 'Structure of metaphysis'}, {'cui': 'C0242696', 'cui_str': 'Diaphyses'}]",,0.0375607,"25OHD increased and BAP, TRAP and OCN all decreased in the Ca + D group (p < .05).","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Gaffney-Stomberg', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America. Electronic address: erin.g.stomberg.civ@mail.mil.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Nakayama', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America; Oak Ridge Institute for Science and Education, Oakridge, TN 37830, United States of America.'}, {'ForeName': 'Katelyn I', 'Initials': 'KI', 'LastName': 'Guerriere', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Lutz', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Walker', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America.'}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Staab', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Scott', 'Affiliation': 'Department of Military and Emergency Medicine, Uniformed Services University of Health Sciences, Bethesda, MD 20814, United States of America.'}, {'ForeName': 'Heath G', 'Initials': 'HG', 'LastName': 'Gasier', 'Affiliation': 'Department of Military and Emergency Medicine, Uniformed Services University of Health Sciences, Bethesda, MD 20814, United States of America.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McClung', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, United States of America.'}]",Bone,['10.1016/j.bone.2019.03.021']
2856,31994819,Need for pacing in patients who qualify for an implantable cardioverter-defibrillator: Clinical implications for the subcutaneous ICD.,"BACKGROUND


Implantation of the subcutaneous implantable cardioverter-defibrillator (S-ICD) is spreading and has been shown to be safe and effective; however, it does not provide brady-pacing. Currently, data on the need for brady-pacing and cardiac resynchronization therapy (CRT) implantation in patients with ICD indication are limited.
METHODS


The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II enrolled post-MI patients with reduced ejection fraction (EF ≤ 35%), randomized to either an implantable cardioverter-defibrillator (ICD) or conventional medical therapy. Kaplan-Meier analyses and multivariate Cox models were performed to assess the incidence and predictors of pacemaker (PM), or CRT implantation in the conventional arm of MADIT-II, after excluding 32 patients (6.5%) with a previously implanted PM.
RESULTS


During the median follow-up of 20 months, 24 of 458 patients (5.2%) were implanted with a PM or a CRT (19 PM, 5 CRT). Symptomatic sinus bradycardia was the primary indication for PM implantation (n = 9, 37%), followed by AV block (n = 5, 21%), tachy-brady syndrome (n = 4, 17%), and carotid sinus hypersensitivity (n = 1, 4%). Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation. Patients with PM/CRT implantation had a significantly higher risk for heart failure (HR = 2.67, 95% CI = 1.38-5.14, p = .003), but no increased mortality risk (HR = 1.06, 95% CI = 0.46-2.46, p = .89).
CONCLUSION


The short-term need for ventricular pacing or CRT implantation in patients with MADIT-II ICD indication was low, especially in those with a normal baseline PR interval, and such patients are appropriate candidates for the subcutaneous ICD.",2020,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","['patients with ICD', 'MI patients with reduced ejection fraction (EF\xa0≤\xa035', 'patients who qualify for an implantable cardioverter-defibrillator']","['ventricular pacing or CRT implantation', 'subcutaneous implantable cardioverter-defibrillator (S-ICD', 'cardiac resynchronization therapy (CRT) implantation', 'implantable cardioverter-defibrillator (ICD) or conventional medical therapy']","['incidence and predictors of pacemaker (PM), or CRT implantation', 'carotid sinus hypersensitivity', 'mortality risk', 'Symptomatic sinus bradycardia', 'risk for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0741983', 'cui_str': 'Carotid sinus hypersensitivity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0748712', 'cui_str': 'Symptomatic sinus bradycardia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.084377,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Spencer Z', 'Initials': 'SZ', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Brown', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12744']
2857,31560241,An early experience of Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis (CLIP-SP) study.,"An increase in number of peritoneal dialysis patients and demand for peritoneal dialysis products following implementation of ""PD First"" policy in Thailand has led to logistics supply chain challenges and inherent product quality problems. Available evidences suggested that defective peritoneal dialysis products may predispose the patients to peritonitis. Thailand Clinical Practice Guideline for Peritoneal Dialysis 2017 recommends the patients to check peritoneal dialysis products themselves before use. In this report, we present our early experience from the Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis study, a cluster randomized trial conducted in 22 peritoneal dialysis centers in Thailand. Patients from 11 randomly selected sites were asked to use the check list to report any product quality defects. The peritoneal dialysis product check list required patients to check the expiration date, glucose concentration, clarity, color, and integrity of bags of peritoneal dialysis fluid as well as the peritoneal dialysis connectors prior to each use. Among 338 patients who had received the check list from 5 centers, 28 returned the reports, detecting 8 defects out of 3960 products in total (0.2%). Although the obtained check list reports were not perfectly completed, they were comprehensible and provided important information on product defects which meant that the check list was simple enough for the patients and/or caregivers to follow. In conclusion, despite low response rate and incomplete report in this early phase analysis, the check list provides important information on product defects while an impact of these defects on peritoneal dialysis outcomes requires a further investigation.",2020,"An increase in number of peritoneal dialysis patients and demand for peritoneal dialysis products following implementation of ""PD First"" policy in Thailand has led to logistics supply chain challenges and inherent product quality problems.","['22 peritoneal dialysis centers in Thailand', '338 patients who had received the check list from 5 centers, 28 returned the reports, detecting 8 defects out of 3960 products in total (0.2']",[],"['expiration date, glucose concentration, clarity, color, and integrity of bags of peritoneal dialysis fluid']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]",[],"[{'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",8.0,0.0227797,"An increase in number of peritoneal dialysis patients and demand for peritoneal dialysis products following implementation of ""PD First"" policy in Thailand has led to logistics supply chain challenges and inherent product quality problems.","[{'ForeName': 'Kullaya', 'Initials': 'K', 'LastName': 'Takkavatakarn', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pongpratch', 'Initials': 'P', 'LastName': 'Puapatanakul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Talerngsak', 'Initials': 'T', 'LastName': 'Kanjanabuch', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanchanok', 'Initials': 'T', 'LastName': 'Buanet', 'Affiliation': 'Nakornping Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Thongbor', 'Affiliation': 'Sunpasithiprasong Hospital, Ubon Ratchathani, Thailand.'}, {'ForeName': 'Salakjit', 'Initials': 'S', 'LastName': 'Pitakmongkol', 'Affiliation': 'Pranangklao Hospital, Nonthaburi, Thailand.'}, {'ForeName': 'Niparat', 'Initials': 'N', 'LastName': 'Pikul', 'Affiliation': 'Amnat Charoen Hospital, Amnat Charoen, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Pongpirul', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",The International journal of artificial organs,['10.1177/0391398819876943']
2858,31991017,Novel modified Peyton's approach for knowledge retention on newborn life support training in medical students.,"AIM


We sought to improve retention of neonatal resuscitation skills by modifying step 3 through additional functional verbalisation in Peyton's four-step approach (P4S).
METHODS


Newborn life support (NLS) training was performed in a simulation-based setting. In contrast to the traditional approach, students taught with the modified approach were requested to explain every step of their performance in Peyton's step 3. A total of 123 students were allocated into both experimental groups. Students were then assessed by megacode on day four (initial assessment) and 6 months (follow-up assessment).
RESULTS


Both groups showed similar scorings in the initial, follow-up assessment and in mean change. On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group. All showed a significant loss of performance irrespective of modification in step 3 in the follow-up assessment. Only time until start with post-resuscitation care shows a significant group difference in mean change between initial and follow-up with increasing time in the control and decreasing time span in intervention group.
CONCLUSION


Both methods showed equal levels of knowledge acquisition and long-term decline in NLS performances. Verbalisation in step 3 influenced speed of applied NLS performance.",2020,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","['123 Students', 'medical students']","['Novel modified Peyton approach', 'Newborn life support (NLS) training']","['speed of applied NLS performance', 'equal levels of knowledge acquisition and long-term decline in NLS performances', 'time span']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",123.0,0.013784,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","[{'ForeName': 'Nasenien', 'Initials': 'N', 'LastName': 'Nourkami-Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Hilleke', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagenpfeil', 'Affiliation': 'Saarland University Medical Center, Institute of Medical Biometry, Epidemiology and Medical Informatics, Homburg, Germany.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15198']
2859,32111701,A Coaching Program to Improve Dietary Intake of Patients with CKD: ENTICE-CKD.,"BACKGROUND AND OBJECTIVES


The dietary self-management of CKD is challenging. Telehealth interventions may provide an effective delivery method to facilitate sustained dietary change.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This pilot, randomized, controlled trial evaluated secondary and exploratory outcomes after a dietitian-led telehealth coaching intervention to improve diet quality in people with stage 3-4 CKD. The intervention group received phone calls every 2 weeks for 3 months (with concurrent, tailored text messages for 3 months), followed by 3 months of tailored text messages without telephone coaching, to encourage a diet consistent with CKD guidelines. The control group received usual care for 3 months, followed by nontailored, educational text messages for 3 months.
RESULTS


Eighty participants (64% male), aged 62±12 years, were randomized to the intervention or control group. Telehealth coaching was safe, with no adverse events or changes to serum biochemistry at any time point. At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5). There was no change in clinic BP at any time point in any group. There were significant improvements in several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight.
CONCLUSIONS


Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in several exploratory diet and clinical outcomes, which require further investigation.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Evaluation of Individualized Telehealth Intensive Coaching to Promote Healthy Eating and Lifestyle in CKD (ENTICE-CKD), ACTRN12616001212448.",2020,"At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5).","['Patients with CKD', 'people with stage 3-4 CKD', 'Eighty participants (64% male), aged 62±12 years']","['dietitian-led telehealth coaching intervention', 'usual care for 3 months, followed by nontailored, educational text messages for 3 months']","['Alternative Health Eating Index', 'clinic BP', 'several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight', 'Alternative Healthy Eating Index or clinic BP', 'diet quality', 'overall diet quality', 'several exploratory diet and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0615138,"At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5).","[{'ForeName': 'Jaimon T', 'Initials': 'JT', 'LastName': 'Kelly', 'Affiliation': 'Faculty of Health Science and Medicine and jaimon.kelly@uq.edu.au.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Conley', 'Affiliation': 'Department of Nutrition and Dietetics and.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Centre for Research in Evidence Based Practice, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Craig', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tong', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dianne P', 'Initials': 'DP', 'LastName': 'Reidlinger', 'Affiliation': 'Faculty of Health Science and Medicine and.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'School of Public Health, Faculty of Medicine and.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rathika', 'Initials': 'R', 'LastName': 'Krishnasamy', 'Affiliation': 'Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Kurtkoti', 'Affiliation': 'Department of Renal Medicine, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand; and.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Centre for Kidney Disease Research, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Faculty of Health Science and Medicine and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12341019']
2860,32014845,A Mobile Health Team Challenge to Promote Stepping and Stair Climbing Activities: Exploratory Feasibility Study.,"BACKGROUND


Mobile health (mHealth) approaches are growing in popularity as a means of addressing low levels of physical activity (PA).
OBJECTIVE


This study aimed to determine the validity of wearables in measuring step count and floor count per day and assess the feasibility and effects of a 6-week team challenge intervention delivered through smartphone apps.
METHODS


Staff and students from a public university were recruited between 2015 and 2016. In phase 1, everyone wore a Fitbit tracker (Charge or Charge HR) and an ActiGraph for 7 days to compare daily step count estimated by the two devices under free-living conditions. They were also asked to climb 4 bouts of floors in an indoor stairwell to measure floor count which was compared against direct observation. In phase 2, participants were allocated to either a control or intervention group and received a Fitbit tracker synced to the Fitbit app. Furthermore, the intervention group participants were randomized to 4 teams and competed in 6 weekly (Monday to Friday) real-time challenges. A valid day was defined as having 1500 steps or more per day. The outcomes were as follows: (1) adherence to wearing the Fitbit (ie, number of days in which all participants in each group were classified as valid users aggregated across the entire study period), (2) mean proportion of valid participants over the study period, and (3) the effects of the intervention on step count and floor count determined using multiple linear regression models and generalized estimating equations (GEEs) for longitudinal data analysis.
RESULTS


In phase 1, 32 of 40 eligible participants provided valid step count data, whereas all 40 participants provided valid floor count data. The Fitbit trackers demonstrated high correlations (step count: Spearman ρ=0.89; P<.001; floor count: Spearman ρ=0.98; P<.001). The trackers overestimated step count (median absolute error: 17%) but accurately estimated floor count. In phase 2, 20 participants each were allocated to an intervention or control group. Overall, 24 participants provided complete covariates and valid PA data for analyses. Multiple linear regressions revealed that the average daily steps was 15.9% higher for the intervention group (95% CI -8.9 to 47.6; P=.21) during the final two intervention weeks; the average daily floors climbed was 39.4% higher (95% CI 2.4 to 89.7; P=.04). GEE results indicated no significant interaction effects between groups and the intervention week for weekly step count, whereas a significant effect (P<.001) was observed for weekly floor count.
CONCLUSIONS


The consumer wearables used in this study provided acceptable validity in estimating stepping and stair climbing activities, and the mHealth-based team challenge interventions were feasible. Compared with the control group, the participants in the intervention group climbed more stairs, so this can be introduced as an additional PA promotion target in the context of mHealth strategies. Methodologically rigorous studies are warranted to further strengthen this study's findings.",2020,Multiple linear regressions revealed that the average daily steps was 15.9% higher for the intervention group (95% CI -8.9 to 47.6; P=.21) during the final two intervention weeks; the average daily floors climbed was 39.4% higher (95% CI 2.4 to 89.7; P=.04).,"['Staff and students from a public university were recruited between 2015 and 2016', '20 participants each were allocated to an intervention or control group']","['control or intervention group and received a Fitbit tracker synced to the Fitbit app', 'everyone wore a Fitbit tracker (Charge or Charge HR) and an ActiGraph']","['valid floor count data', 'average daily floors climbed', 'average daily steps']","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.0490197,Multiple linear regressions revealed that the average daily steps was 15.9% higher for the intervention group (95% CI -8.9 to 47.6; P=.21) during the final two intervention weeks; the average daily floors climbed was 39.4% higher (95% CI 2.4 to 89.7; P=.04).,"[{'ForeName': 'Seaw Jia', 'Initials': 'SJ', 'LastName': 'Liew', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Alex Wilhelm', 'Initials': 'AW', 'LastName': 'Gorny', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Chuen Seng', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Müller-Riemenschneider', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/12665']
2861,32014846,"The Effect of Smartphone Apps Versus Supervised Exercise on Physical Activity, Cardiorespiratory Fitness, and Body Composition Among Individuals With Mild-to-Moderate Mobility Disability: Randomized Controlled Trial.","BACKGROUND


Adequate levels of physical activity (PA) and good cardiorespiratory fitness (CRF) are associated with profound health benefits for individuals with mobility disability (MD). Despite the vast amount of research published in the field of PA interventions, little attention has been given to individuals with MD.
OBJECTIVE


The aim of this study was to examine the efficacy of an app-based versus a supervised exercise and health coaching program to support adults with MD to increase levels of PA, CRF, and improve body composition.
METHODS


Participants with self-perceived MD, aged 18 to 45 years, were included in this 12-week parallel-group randomized controlled trial and allocated at random to an app-based intervention, using commercially available apps-the Swedish Military training app (FMTK), the Acupedo walking app, and the LogMyFood food photography app-or a supervised exercise and health coaching intervention, including 1 weekly supervised exercise session and healthy lifestyle coaching. The primary outcome was the level of moderate-to-vigorous PA (MVPA) measured with accelerometers. Secondary outcomes included CRF measured by a submaximal test performed on a stationary bicycle and body composition measured by bioelectrical impedance. All outcomes were measured at baseline, 6 weeks, and 12 weeks. Linear mixed-effect models were used to assess the between-group differences, as well as the within-group changes through time, in each intervention group.
RESULTS


A total of 110 participants with MD were randomized to an app-based intervention (n=55) or a supervised exercise and health intervention (n=55). The mean age of participants was 34.9 years (SD 6.1), and 81.8% (90/110) of the participants were women. CRF showed a moderate increase in both groups after 12 weeks-1.07 (95% CI -0.14 to 2.27) mL/kg/min increase in the app-based group and 1.76 (95% CI 0.70 to 2.83) mLkg/min increase in the supervised exercise group. However, the intention-to-treat analysis showed no significant differences between the groups in MVPA or CRF after 12 weeks. Waist circumference was significantly lower in the app-based intervention group.
CONCLUSIONS


Commercially available apps increased levels of CRF and improved body composition over 12 weeks to the same extent as supervised exercise sessions, showing that both are equally effective. However, neither the app-based intervention nor the supervised exercise intervention increased MVPA.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 22387524; http://isrctn.com/ISRCTN22387524.",2020,CRF showed a moderate increase in both groups after 12 weeks-1.07 (95% CI -0.14 to 2.27) mL/kg/min increase in the app-based group and 1.76,"['Participants with self-perceived MD, aged 18 to 45 years', 'adults with MD', 'The mean age of participants was 34.9 years (SD 6.1), and 81.8% (90/110) of the participants were women', '110 participants with MD', 'individuals with MD', 'Individuals With Mild-to-Moderate Mobility Disability', 'individuals with mobility disability (MD']","['Smartphone Apps Versus Supervised Exercise', 'app-based intervention (n=55) or a supervised exercise and health intervention', 'supervised exercise and health coaching program', 'app-based intervention, using commercially available apps-the Swedish Military training app (FMTK), the Acupedo walking app, and the LogMyFood food photography app-or a supervised exercise and health coaching intervention, including 1 weekly supervised exercise session and healthy lifestyle coaching', 'supervised exercise intervention']","['PA, CRF, and improve body composition', 'level of moderate-to-vigorous PA (MVPA', 'CRF measured by a submaximal test performed on a stationary bicycle and body composition measured by bioelectrical impedance', 'levels of CRF and improved body composition', 'Waist circumference', 'Physical Activity, Cardiorespiratory Fitness, and Body Composition', 'CRF']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C1285593', 'cui_str': 'Body composition measure'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",110.0,0.10861,CRF showed a moderate increase in both groups after 12 weeks-1.07 (95% CI -0.14 to 2.27) mL/kg/min increase in the app-based group and 1.76,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berglind', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Yacaman-Mendez', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lavebratt', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/14615']
2862,32111704,Urine Markers of Kidney Tubule Cell Injury and Kidney Function Decline in SPRINT Trial Participants with CKD.,"BACKGROUND AND OBJECTIVES


eGFR and albuminuria primarily reflect glomerular function and injury, whereas tubule cell atrophy and interstitial fibrosis on kidney biopsy are important risk markers for CKD progression. Kidney tubule injury markers have primarily been studied in hospitalized AKI. Here, we examined the association between urinary kidney tubule injury markers at baseline with subsequent loss of kidney function in persons with nondiabetic CKD who participated in the Systolic Blood Pressure Intervention Trial (SPRINT).
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Among 2428 SPRINT participants with CKD (eGFR<60 ml/min per 1.73 m 2 ) at baseline, we measured urine markers of tubule injury (IL-18, kidney injury molecule-1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL]), inflammation (monocyte chemoattractant protein-1 [MCP-1]), and repair (human cartilage glycoprotein-40 [YKL-40]). Cox proportional hazards models evaluated associations of these markers with the kidney composite outcome of 50% eGFR decline or ESKD requiring dialysis or kidney transplantation, and linear mixed models evaluated annualized change in eGFR.
RESULTS


Mean participant age was 73±9 (SD) years, 60% were men, 66% were white, and mean baseline eGFR was 46±11 ml/min per 1.73 m 2 . There were 87 kidney composite outcome events during a median follow-up of 3.8 years. Relative to the respective lowest quartiles, the highest quartiles of urinary KIM-1 (hazard ratio, 2.84; 95% confidence interval [95% CI], 1.31 to 6.17), MCP-1 (hazard ratio, 2.43; 95% CI, 1.13 to 5.23), and YKL-40 (hazard ratio, 1.95; 95% CI, 1.08 to 3.51) were associated with higher risk of the kidney composite outcome in fully adjusted models including baseline eGFR and urine albumin. In linear analysis, urinary IL-18 was the only marker associated with eGFR decline (-0.91 ml/min per 1.73 m 2  per year for highest versus lowest quartile; 95% CI, -1.44 to -0.38), a finding that was stronger in the standard arm of SPRINT.
CONCLUSIONS


Urine markers of tubule cell injury provide information about risk of subsequent loss of kidney function, beyond the eGFR and urine albumin.",2020,"In linear analysis, urinary IL-18 was the only marker associated with eGFR decline (-0.91 ml/min per 1.73 m 2  per year for highest versus lowest quartile; 95% CI, -1.44 to -0.38), a finding that was stronger in the standard arm of SPRINT.
","['persons with nondiabetic CKD who participated in the Systolic Blood Pressure Intervention Trial (SPRINT', 'Mean participant age was 73±9 (SD) years, 60% were men, 66% were white, and mean baseline eGFR was 46±11 ml/min per 1.73 m 2 ', 'SPRINT Trial Participants with CKD', 'Among 2428 SPRINT participants with CKD (eGFR<60 ml/min per 1.73 m 2 ) at baseline']",[],"['YKL-40', 'highest quartiles of urinary KIM-1', 'eGFR decline', 'Urine Markers of Kidney Tubule Cell Injury and Kidney Function Decline', 'MCP-1', 'urinary IL-18', 'urine markers of tubule injury (IL-18, kidney injury molecule-1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL]), inflammation (monocyte chemoattractant protein-1 [MCP-1]), and repair (human cartilage glycoprotein-40 [YKL-40']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0022674', 'cui_str': 'Kidney Tubules'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}]",2428.0,0.222813,"In linear analysis, urinary IL-18 was the only marker associated with eGFR decline (-0.91 ml/min per 1.73 m 2  per year for highest versus lowest quartile; 95% CI, -1.44 to -0.38), a finding that was stronger in the standard arm of SPRINT.
","[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine and.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco Veterans Affairs Medical Center and University of California, San Francisco, California.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences and.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health and Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health and Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Trinity Hypertension and Metabolic Research Instititute, Punzi Medical Center, Carrollton, Texas.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine and joeix@ucsd.edu.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco Veterans Affairs Medical Center and University of California, San Francisco, California.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.02780319']
2863,31751782,Risk factors for reporting adverse events and for study withdrawal in a population-based trial of vitamin D supplementation.,"With increasing numbers of randomized controlled trials (RCTs) investigating potential health events of vitamin D supplementation, a better understanding is required of the risk factors for adverse events and for study withdrawals. This analysis aimed to identify baseline risk factors of reporting an adverse event in a multi-year randomized double-blinded placebo-controlled trial of vitamin D supplementation. The secondary aim was to investigate if adverse events were associated with study withdrawals. We analyzed data from the Vitamin D Assessment (ViDA) study: 5110 adults, aged 50-84 years, living in Auckland, New Zealand. Monthly doses of 100,000 IU vitamin D3 or placebo were mailed to participants homes, with a questionnaire to collect data on adverse events and adherence to the study capsule (initially monthly, then 4-monthly). Median follow-up was 3.3 years. Data were analysed using multivariable log-binomial regression and Cox-regression. During the follow-up period, 818 people reported adverse events and 412 withdrew or stopped returning questionnaires. Vitamin D was not associated with reporting of adverse events. Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event. Non-smokers were more likely to report an adverse event, compared to smokers (adjusted hazard ratio (HR) = 1.80; 95%CI = 1.24, 2.62); as were those who had reported a history of depression (adjusted HR = 1.27; 95%CI = 1.01, 1.60) or a recent cough or cold (adjusted HR = 1.22; 95%CI = 1.03, 1.44) at baseline. Reporting of adverse events was not associated with withdrawals (adjusted HR = 1.12; 95%CI = 0.86, 1.46). These data did not identify any clear pattern in the factors associated with self-reported adverse events, which themselves did not increase risk of withdrawals.",2020,"Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event.","['5,110 adults, aged 50-84 years, living in Auckland, New Zealand']","['placebo', 'vitamin D supplementation', 'vitamin D3 or placebo', 'Vitamin D']","['history of depression', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",818.0,0.556737,"Of sociodemographic factors, ethnicity was associated with reporting adverse events: compared to European participants, Maori and Pacific Islander people were more likely to report an adverse event.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Malihi', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'Cmm', 'Initials': 'C', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, New Zealand.'}, {'ForeName': 'K-T', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, England, United Kingdom.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2019.105546']
2864,32152202,Outcome-Related Signatures Identified by Whole Transcriptome Sequencing of Resectable Stage III/IV Melanoma Evaluated after Starting Hu14.18-IL2.,"PURPOSE


We analyzed whole transcriptome sequencing in tumors from 23 patients with stage III or IV melanoma from a pilot trial of the anti-GD2 immunocytokine, hu14.18-IL2, to identify predictive immune and/or tumor biomarkers in patients with melanoma at high risk for recurrence.
EXPERIMENTAL DESIGN


Patients were randomly assigned to receive the first of three monthly courses of hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known diseases. Tumors were evaluated by histology and whole transcriptome sequencing.
RESULTS


Tumor-infiltrating lymphocyte (TIL) levels directly associated with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed. TIL levels directly associated with a previously reported immune signature, which associated with RFS and OS, particularly in Group A tumors. In Group A tumors, there were decreased cell-cycling gene RNA transcripts, but increased RNA transcripts for repair and growth genes. We found that outcome (RFS and OS) was directly associated with several immune signatures and immune-related RNA transcripts and inversely associated with several tumor growth-associated transcripts, particularly in Group A tumors. Most of these associations were not seen in Group B tumors.
CONCLUSIONS


We interpret these data to signify that both immunologic and tumoral cell processes, as measured by RNA-sequencing analyses detected shortly after initiation of hu14.18-IL2 therapy, are associated with long-term survival and could potentially be used as prognostic biomarkers in tumor resection specimens obtained after initiating neoadjuvant immunotherapy.",2020,"RESULTS


Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","['23 patients with stage III or IV melanoma', 'Patients', 'melanoma patients at high risk for recurrence']",['hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known disease'],"['Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS', 'cell cycling gene RNA transcripts', 'Outcome-related signatures identified by Whole Transcriptome Sequencing of Resectable Stage III', 'RNA transcripts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C1529682', 'cui_str': 'EMD 273063'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0079722', 'cui_str': 'Lymphocytes, Tumor-Infiltrating'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]",23.0,0.0462348,"RESULTS


Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","[{'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Igor B', 'Initials': 'IB', 'LastName': 'Kuznetsov', 'Affiliation': 'Cancer Research Center and Department of Epidemiology and Biostatistics, University at Albany, Rensselaer, New York.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jun S', 'Initials': 'JS', 'LastName': 'Wei', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Sivasish', 'Initials': 'S', 'LastName': 'Sindiri', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Berkley E', 'Initials': 'BE', 'LastName': 'Gryder', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Vineela', 'Initials': 'V', 'LastName': 'Gangalapudi', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Viharkumar', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Zuleger', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Erbe', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Morris', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Quale', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Albertini', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3294']
2865,31952627,Changes in DSM criteria following a culturally-adapted computerized CBT for Spanish-speaking individuals with substance use disorders.,"This study sought to replicate and extend findings regarding change in the number of endorsed Diagnostic and Statistical Manual (DSM) criteria for substance use disorders as a meaningful outcome for clinical trials with Spanish-speakers. A secondary analysis was conducted of data from 83 treatment-seeking individuals with current DSM-IV substance dependence participating in a randomized controlled trial evaluating a culturally-adapted version of a computer-based cognitive behavioral therapy program (CBT4CBT) for Spanish-speakers. Participants were randomized to either weekly standard outpatient counseling (treatment as usual - TAU), or TAU plus access to CBT4CBT (TAU+CBT4CBT). The Structured Clinical Interview for DSM-IV (SCID-IV) was administered at baseline and at the end of the 8-week treatment period to measure change in diagnostic status and total criteria count. Frequency of substance use during treatment and throughout a 6-month follow-up period was measured by self-report using a calendar-based Timeline FollowBack method, with abstinence verified through instant urine toxicology, and problem severity was measured with the Addiction Severity Index (ASI). Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only. Total criteria count and diagnostic status at end-of-treatment was significantly correlated with substance use outcomes during the follow-up period, such that fewer criteria endorsed were associated with greater rates of abstinence and lower problem severity. These findings paralleled the primary outcomes from the main trial, and replicated prior findings in English-speakers regarding the utility of DSM criteria count as a potential clinically meaningful outcome.",2020,"Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only.","['Spanish-speakers', '83 treatment-seeking individuals with current DSM-IV substance dependence participating']","['standard outpatient counseling (treatment as usual - TAU), or TAU plus access to CBT4CBT (TAU+CBT4CBT', 'culturally-adapted version of a computer-based cognitive behavioral therapy program (CBT4CBT', 'TAU+CBT4CBT']","['Total criteria count and diagnostic status', 'Addiction Severity Index (ASI', 'rates of abstinence and lower problem severity', 'total count of DSM-IV dependence criteria']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0038580', 'cui_str': 'Substance Dependence'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",83.0,0.0259403,"Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only.","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Silva', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Yudilyn', 'Initials': 'Y', 'LastName': 'Jaramillo', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Añez-Nava', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America. Electronic address: Brian.kiluk@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.006']
2866,31903588,Randomized clinical trial of intraoperative dexmedetomidine to prevent delirium in the elderly undergoing major non-cardiac surgery.,"BACKGROUND


Delirium is common in elderly patients after surgery and is associated with poor outcomes. This study aimed to investigate the impact of intraoperative dexmedetomidine on the incidence of delirium in elderly patients undergoing major surgery.
METHODS


This was a randomized double-blind placebo-controlled trial. Elderly patients (aged 60 years or more) scheduled to undergo major non-cardiac surgery were randomized into two groups. Patients in the intervention group received a loading dose of dexmedetomidine 0·6 μg/kg 10 min before induction of anaesthesia followed by a continuous infusion (0·5 μg per kg per h) until 1 h before the end of surgery. Patients in the control group received volume-matched normal saline in the same schedule. The primary outcome was the incidence of delirium during the first 5 days after surgery. Delirium was assessed with the Confusion Assessment Method (CAM) for non-ventilated patients and CAM for the Intensive Care Unit for ventilated patients.
RESULTS


In total, 309 patients who received dexmedetomidine and 310 control patients were included in the intention-to-treat analysis. The incidence of delirium within 5 days of surgery was lower with dexmedetomidine treatment: 5·5 per cent (17 of 309) versus 10·3 per cent (32 of 310) in the control group (relative risk (RR) 0·53, 95 per cent c.i. 0·30 to 0·94; P = 0·026). The overall incidence of complications at 30 days was also lower after dexmedetomidine (19·4 per cent (60 of 309) versus 26·1 per cent (81 of 310) for controls; RR 0·74, 0·55 to 0·99, P = 0·047).
CONCLUSION


Intraoperative dexmedetomidine halved the risk of delirium in the elderly after major non-cardiac surgery. Registration number: ChiCTR-IPR-15007654 ( www.chictr.org.cn).",2020,The overall incidence of complications at 30 days was also lower after dexmedetomidine (19·4 per cent (60 of 309) versus 26·1 per cent (81 of 310) for controls;,"['Elderly patients (aged 60\u2009years or more) scheduled to undergo major non-cardiac surgery', 'elderly patients after surgery', 'and 310 control patients were included in the intention-to-treat analysis', 'elderly undergoing major non-cardiac surgery', '309 patients who received', 'elderly patients undergoing major surgery', 'elderly after major non-cardiac surgery']","['placebo', 'dexmedetomidine 0·6', 'dexmedetomidine', 'intraoperative dexmedetomidine', 'volume-matched normal saline']","['incidence of delirium', 'Delirium', 'overall incidence of complications', 'risk of delirium']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",309.0,0.639431,The overall incidence of complications at 30 days was also lower after dexmedetomidine (19·4 per cent (60 of 309) versus 26·1 per cent (81 of 310) for controls;,"[{'ForeName': 'C-J', 'Initials': 'CJ', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}, {'ForeName': 'B-J', 'Initials': 'BJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}, {'ForeName': 'D-L', 'Initials': 'DL', 'LastName': 'Mu', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Section of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}, {'ForeName': 'D-X', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Beijing, China.'}]",The British journal of surgery,['10.1002/bjs.11354']
2867,31780395,Deep Learning for the Classification of Small (≤2 cm) Pulmonary Nodules on CT Imaging: A Preliminary Study.,"RATIONALE AND OBJECTIVES


We aimed to present a deep learning-based malignancy prediction model (CT-lungNET) that is simpler and faster to use in the diagnosis of small (≤2 cm) pulmonary nodules on nonenhanced chest CT and to preliminarily evaluate its performance and usefulness for human reviewers.
MATERIALS AND METHODS


A total of 173 whole nonenhanced chest CT images containing 208 pulmonary nodules (94 malignant and 11 benign nodules) ranging in size from 5 mm to 20 mm were collected. Pathologically confirmed nodules or nodules that remained unchanged for more than 1 year were included, and 30 benign and 30 malignant nodules were randomly assigned into the test set. We designed CT-lungNET to include three convolutional layers followed by two fully-connected layers and compared its diagnostic performance and processing time with those of AlexNET by using the area under the receiver operating curve (AUROC). An observer performance test was conducted involving eight human reviewers of four different groups (medical students, physicians, radiologic residents, and thoracic radiologists) at test 1 and test 2, referring to the CT-lungNET's malignancy prediction rate with pairwise comparison receiver operating curve analysis.
RESULTS


CT-lungNET showed an improved AUROC (0.85; 95% confidence interval: 0.74-0.93), compared to that of the AlexNET (0.82; 95% confidence interval: 0.71-0.91). The processing speed per one image slice for CT-lungNET was about 10 times faster than that for AlexNET (0.90 vs. 8.79 seconds). During the observer performance test, the classification performance of nonradiologists was increased with the aid of CTlungNET, (mean AUC improvement: 0.13; range: 0.03-0.19) but not significantly so in the radiologists group (mean AUC improvement: 0.02; range: -0.02 to 0.07).
CONCLUSION


CT-lungNET was able to provide better classification results with a significantly shorter amount of processing time as compared to AlexNET in the diagnosis of small pulmonary nodules on nonenhanced chest CT. In this preliminary observer performance test, CT-lungNET may have a role acting as a second reviewer for less experienced reviewers, resulting in enhanced performance in the diagnosis of early lung cancer.",2020,"RESULTS


CT-lungNET showed an improved AUROC (0.85; 95% confidence interval: 0.74-0.93), compared to that of the AlexNET (0.82; 95% confidence interval: 0.71-0.91).","['Small (≤2 cm', ""eight human reviewers of four different groups (medical students, physicians, radiologic residents, and thoracic radiologists) at test 1 and test 2, referring to the CT-lungNET's malignancy prediction rate with pairwise comparison receiver operating curve analysis"", 'Pathologically confirmed nodules or nodules that remained unchanged for more than 1 year were included, and 30 benign and 30 malignant nodules', 'A total of 173 whole nonenhanced chest CT images containing 208 pulmonary nodules (94 malignant and 11 benign nodules) ranging in size from 5 mm to 20 mm were collected']","['AlexNET', 'CT Imaging', 'deep learning-based malignancy prediction model (CT-lungNET', 'CT-lungNET']",['classification performance of nonradiologists'],"[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0260194', 'cui_str': 'Radiologist (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202823', 'cui_str': 'Chest CT'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0008903', 'cui_str': 'taxonomy'}]",94.0,0.0562269,"RESULTS


CT-lungNET showed an improved AUROC (0.85; 95% confidence interval: 0.74-0.93), compared to that of the AlexNET (0.82; 95% confidence interval: 0.71-0.91).","[{'ForeName': 'Kum J', 'Initials': 'KJ', 'LastName': 'Chae', 'Affiliation': 'Department of Radiology, Research Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, 634-18 Keumam-Dong, Jeonju, Jeonbuk 561-712, South Korea.'}, {'ForeName': 'Gong Y', 'Initials': 'GY', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, Research Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, 634-18 Keumam-Dong, Jeonju, Jeonbuk 561-712, South Korea. Electronic address: gyjin@chonbuk.ac.kr.'}, {'ForeName': 'Seok B', 'Initials': 'SB', 'LastName': 'Ko', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Eun J', 'Initials': 'EJ', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Research Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, 634-18 Keumam-Dong, Jeonju, Jeonbuk 561-712, South Korea.'}, {'ForeName': 'Hyemi', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Statistics and Institute of Applied Statistics, Chonbuk National University, Jeonju, South Korea.'}]",Academic radiology,['10.1016/j.acra.2019.05.018']
2868,32144172,'I can do this': a qualitative exploration of acceptability and experiences of a physical activity behaviour change intervention in people with multiple sclerosis in the UK.,"OBJECTIVES


The purpose of this study was to explore the experiences of people with multiple sclerosis (MS) who participated in iStep-MS, a feasibility randomised controlled trial of a behaviour change intervention that aimed to increase physical activity and reduce sedentary behaviour.
DESIGN


A qualitative approach was undertaken embedded in the feasibility randomised controlled trial. One-to-one semi-structured interviews were conducted and analysed using Framework analysis.
SETTING


Participants were recruited from a single MS therapy centre in the southeast of England, UK.
PARTICIPANTS


Sixty people with MS were randomly allocated in a 1:1 ratio to the intervention or usual care. Following a purposive sampling strategy, 15 participants from the intervention arm undertook 1:1 semi-structured interviews.
INTERVENTIONS


The iStep-MS intervention consisted of four therapist-led sessions over 12 weeks, supported by a handbook and pedometer.
RESULTS


Three themes were identified from the data.  ""I can do this"": developing competence in physical activity  highlights the enhanced physical activity confidence gained through goal setting and accomplishment. "" I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship. Finally, "" What can I do?"": empowered enactment  describes the transition from the supported iStep-MS intervention to intrinsically motivated physical activity enactment.
CONCLUSIONS


Overall, this study supports the acceptability of the iStep-MS intervention and identified key areas that supported participants to be physically active.
TRIAL REGISTRATION NUMBER


ISRCTN15343862.",2020,"I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship.","['Sixty people with MS', 'Participants were recruited from a single MS therapy centre in the southeast of England, UK', 'people with multiple sclerosis (MS) who participated in iStep-MS', 'people with multiple sclerosis in the UK']","['behaviour change intervention', 'physical activity behaviour change intervention', 'iStep-MS intervention']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],60.0,0.109974,"I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fortune', 'Affiliation': 'University of Dublin Trinity College, Dublin, Ireland fortunej@tcd.ie.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stennett', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'MS Therapy Centre, Norwich, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'de Souza', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdul', 'Affiliation': 'The Berkshire MS Therapy Centre, Reading, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Brewin', 'Affiliation': '10 Minute CBT, London, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'David', 'Affiliation': '10 Minute CBT, London, UK.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': 'Health Economics Research Group, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Victor', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ryan', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029831']
2869,32176364,Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: Results of the PRESS trial.,"BACKGROUND


There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation.
HYPOTHESIS


Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation could provide better clinical outcomes.
METHODS


We randomly assigned 1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
RESULTS


The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880).
CONCLUSIONS


The strategy of routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not provide incremental clinical benefits.",2020,"The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
","['810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled', '1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation']",['everolimus-eluting stent implantation'],"['TVR', 'MI', 'occurrence of an individual end point of death', 'composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2\u2009years after randomization', 'stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",1774.0,0.0811106,"The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
","[{'ForeName': 'Gyung-Min', 'Initials': 'GM', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Jae-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Hyuck-Jun', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Cardiology, Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Kyung Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': 'Department of Cardiology, Eulji University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Ju Yeol', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': ""Department of Cardiology, Cheongju St. Mary's Hospital, Cheongju, South Korea.""}, {'ForeName': 'Woong Gil', 'Initials': 'WG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, South Korea.'}, {'ForeName': 'Rak Kyeong', 'Initials': 'RK', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Mediplex Sejong Hospital, Bucheon, South Korea.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Department of Cardiology, Daejeon St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jin Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Suh', 'Affiliation': 'Department of Cardiology, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.'}, {'ForeName': 'Jae Beom', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Anyang Sam Hospital, Anyang, South Korea.'}, {'ForeName': 'Se-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Seoul National University Bundang Hospital, Bundang, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'In-Whan', 'Initials': 'IW', 'LastName': 'Seong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}]",Clinical cardiology,['10.1002/clc.23355']
2870,32168305,Hypothermia Plus Melatonin in Asphyctic Newborns: A Randomized-Controlled Pilot Study.,"OBJECTIVES


To investigate the effect of adding melatonin to hypothermia treatment on neurodevelopmental outcomes in asphyctic newborns.
DESIGN


Pilot multicenter, randomized, controlled, double-blind clinical trial. Statistical comparison of results obtained in two intervention arms: hypothermia plus placebo and hypothermia plus melatonin.
SETTING


Level 3 neonatal ICU.
PATIENTS


Twenty-five newborns were recruited.
INTERVENTIONS


The hypothermia plus melatonin patients received a daily dose of IV melatonin, 5 mg per kg body weight, for 3 days. General laboratory variables were measured both at neonatal ICU admission and after intervention. All infants were studied with amplitude-integrated electroencephalography and brain MRI within the first week of life. The neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale were applied at the ages of 6 and 18 months.
MEASUREMENTS AND MAIN RESULTS


Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background did not differ between the treatment groups. The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05). There were no differences between the groups according to the Gross Motor Function Classification System and Tardieu motor assessment scales.
CONCLUSIONS


The early addition of IV melatonin to asphyctic neonates is feasible and may improve long-term neurodevelopment. To our knowledge, this is the first clinical trial to analyze the administration of IV melatonin as an adjuvant therapy to therapeutic hypothermia.",2020,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","['Asphyctic Newborns', 'asphyctic newborns', 'Twenty-five newborns were recruited', 'Level 3 neonatal ICU']","['hypothermia plus placebo', 'IV melatonin', 'hypothermia plus melatonin', 'melatonin', 'Hypothermia Plus Melatonin']","['Gross Motor Function Classification System and Tardieu motor assessment scales', 'neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale', 'Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background', 'composite score', 'neurodevelopmental outcomes']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",25.0,0.157979,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jerez-Calero', 'Affiliation': 'All authors: Department of Paediatrics, San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Salvatierra-Cuenca', 'Affiliation': ''}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Benitez-Feliponi', 'Affiliation': ''}, {'ForeName': 'Carmen Elisabeth', 'Initials': 'CE', 'LastName': 'Fernández-Marín', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Narbona-López', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Uberos-Fernández', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Muñoz-Hoyos', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002346']
2871,32169887,"Dietary Advanced Glycation End-products (AGE) and Risk of Breast Cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).","Advanced glycation end-products (AGEs) are implicated in the pathogenesis of several chronic diseases including cancer. AGEs are produced endogenously but can also be consumed from foods. AGE formation in food is accelerated during cooking at high temperatures. Certain high fat or highly processed foods have high AGE values. The objective of the study was to assign and quantify N ϵ -carboxymethyl-lysine (CML)-AGE content in food and investigate the association between dietary AGE intake and breast cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. The study included women enrolled in the intervention arm who were cancer-free at baseline and completed a baseline questionnaire and food frequency questionnaire (DQX). CML-AGE values were assigned and quantified to foods in the DQX using a published AGE database. Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) of breast cancer among all women, and stratified by race/ethnicity, invasiveness of disease, and hormone receptor status. After a median 11.5 years of follow-up, 1,592 women were diagnosed with breast cancer. Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HR Q5VSQ1 , 1.30; 95% CI, 1.04-1.62;  P   trend  = 0.04) and in non-Hispanic white women (HR T3VST1 , 1.21; 95% CI, 1.02-1.44). Increased CML-AGE intake was associated with increased risk of  in situ  (HR T3VST1 , 1.49; 95% CI, 1.11-2.01) and hormone receptor-positive (HR T3VST1 , 1.24; 95% CI, 1.01-1.53) breast cancers. In conclusion, high intake of dietary AGE may contribute to increased breast cancer.",2020,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","['1,592 women were diagnosed with breast cancer', 'women enrolled in the intervention arm who were cancer-free at baseline and completed a']",[],"['hormone receptor positive (HRT3 VS T1', 'Increased CML-AGE intake', 'risk of breast cancer', 'baseline questionnaire and food frequency questionnaire (DQX']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",1592.0,0.0530889,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","[{'ForeName': 'Omonefe O', 'Initials': 'OO', 'LastName': 'Omofuma', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Turner', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anwar T', 'Initials': 'AT', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. stecks@mailbox.sc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0457']
2872,31599044,Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.,"OBJECTIVE


To compare the outcomes of Aquablation in 30-80 mL prostates with those in 80-150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume.
PATIENTS AND METHODS


Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W-I]; NCT02505919) is a prospective, double-blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W-II; NCT03123250) is a prospective, multicentre, single-arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12-month outcomes in 116 W-I and 101 W-II study patients. Students' t-test or Wilcoxon tests were used for continuous variables and Fisher's test for binary variables.
RESULTS


The mean (SD) operative time was 33 (17) and 37 (13) min in W-I and W-II, respectively. Actual treatment time was 4 and 8 min in W-I and W-II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W-I and 17.1 in W-II (P = 0.605). By 3 months, Clavien-Dindo grade ≥II events occurred in 19.8% of W-I patients and 34.7% of W-II patients (P = 0.468).
CONCLUSION


Aquablation clinically normalises outcomes between patients with 30-80 mL prostates and patients with 80-150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long-term outcomes of procedure durability are needed.",2020,"Mean operative time was 33±17 and 37±13 minutes, in W-I and W-II respectively.","['Benign Prostatic Hyperplasia in 30cc-80cc and 80cc-150cc Prostates', 'prostates between 80cc and 150cc', 'LUTS/BPH in prostates between 30cc and 80cc']","['Aquablation Therapy', 'LUTS/BPH', 'TURP']","['Mean change in IPSS', 'Mean operative time', 'risk of complication', 'Clavien-Dindo grade 2 or higher events']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",116.0,0.0656155,"Mean operative time was 33±17 and 37±13 minutes, in W-I and W-II respectively.","[{'ForeName': 'David-Dan', 'Initials': 'DD', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Frimley Park Hospital, Urology, Frimley, Surrey, UK.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gilling', 'Affiliation': 'Bay of Plenty District Health Board Clinical School, Urology, Tauranga, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Royal Melbourne Hospital, Urology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Zorn', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Division of Urology, Montreal, QC, Canada.""}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Wake Forest School of Medicine, Urology, Winston-Salem, NC, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Humphreys', 'Affiliation': 'Mayo Clinic, Department of Urology, Phoenix, AZ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Kaufman', 'Affiliation': 'Division of Urology, Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'So', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Paterson', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Goldenberg', 'Affiliation': 'University of British Columbia, Urologic Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Elterman', 'Affiliation': 'Division of Urology, University of Toronto, Montréal, QC, Canada.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'USC Institute of Urology, University of Southern California, Urology, Los Angeles, CA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Lingeman', 'Affiliation': 'Institute for Kidney Stone Disease, Methodist Hospital, Indianapolis, IN, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Roehrborn', 'Affiliation': 'UT Southwestern Medical Centre, Urology, Dallas, TX, USA.'}, {'ForeName': 'Naeem', 'Initials': 'N', 'LastName': 'Bhojani', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Division of Urology, Montreal, QC, Canada.""}]",BJU international,['10.1111/bju.14917']
2873,32135135,Glycaemic status during pregnancy and longitudinal measures of fetal growth in a multi-racial US population: a prospective cohort study.,"BACKGROUND


The timepoint at which fetal growth begins to differ by maternal glycaemic status is not well understood. To address this lack of data, we examined gestational diabetes, impaired glucose tolerance, and early pregnancy glucose concentrations in relation to fetal growth trajectories.
METHODS


This cohort study included 2458 pregnant women from the NICHD Fetal Growth Studies-Singletons study, which took place between 2009 and 2013. Women were recruited from 12 clinical centres in the USA. Women aged 18-40 years without major chronic conditions when entering pregnancy were included and those with records of neither glucose screening test or glucose tolerance test were excluded from the study. Women were enrolled at gestational weeks 8-13 and randomly assigned to four ultrasonogram schedules (Group A; weeks 16, 24, 30, 34; Group B: weeks 18, 26, 31, 35, 39; Group C: weeks 20, 28, 32, 36; Group D: weeks 22, 29, 33, 37, 41) to capture weekly fetal growth. Gestational diabetes, impaired glucose tolerance, and normal glucose tolerance were defined by medical record review. Glucose was measured in a subsample of women at weeks 10-14. We modelled fetal growth trajectories using linear mixed models with cubic splines. This study is registered with ClinicalTrials.gov, NCT00912132.
FINDINGS


Of the 2458 women included in this study, 107 (4·4%) had gestational diabetes, 118 (4·8%) had impaired glucose tolerance, and 2020 (82·2%) had NGT. 213 women were excluded from the main analysis. The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061 g [95% CI 2967-3164] for women with gestational diabetes vs 2943 g [2924-2962] for women with normal glucose tolerance, adjusted p=0·02). In addition, glucose levels at weeks 10-14 were positively associated with estimated fetal weight starting at week 23 and the association became significant at week 27 (at week 37: 3073 g [2983-3167] in the highest tertile vs 2853 g [2755-2955] in the lowest tertile, adjusted p=0·0009.
INTERPRETATION


Gestational diabetes was associated with a larger fetal size that started at week 20 and became significant at gestational week 28. Efforts to mitigate gestational diabetes-related fetal overgrowth should start before 24-28 gestational weeks, when gestational diabetes is typically screened for in the USA.
FUNDING


National Institutes of Health.",2020,The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061,"['Women were enrolled at gestational weeks 8-13', 'women with gestational diabetes vs 2943 g', '2458 women included in this study, 107 (4·4%) had gestational diabetes, 118 (4·8%) had impaired glucose tolerance, and 2020 (82·2%) had NGT', '2924-2962] for women with normal glucose tolerance, adjusted p=0·02', 'Women aged 18-40 years without major chronic conditions when entering pregnancy were included and those with records of neither glucose screening test or glucose tolerance test were excluded from the study', '213 women were excluded from the main analysis', '2458 pregnant women from the NICHD Fetal Growth Studies-Singletons study, which took place between 2009 and 2013', 'Women were recruited from 12 clinical centres in the USA']",[],"['glucose levels', 'Glucose', 'estimated fetal weight starting', 'Gestational diabetes, impaired glucose tolerance, and normal glucose tolerance', 'Glycaemic status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",2458.0,0.105319,The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061,"[{'ForeName': 'Mengying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stefanie N', 'Initials': 'SN', 'LastName': 'Hinkle', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sungduk', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jagteshwar', 'Initials': 'J', 'LastName': 'Grewal', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Skupski', 'Affiliation': 'Department of Obstetrics and Gynecology, New York-Presbyterian Hospital Queens, Flushing, NY, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Newman', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sciscione', 'Affiliation': 'Christiana Care Health System, Newark, DE, USA.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Zork', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics-Gynecology, University of California School of Medicine, Irvine, CA, USA; Fountain Valley Regional Hospital and Medical Center, Fountain Valley, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nageotte', 'Affiliation': 'Long Beach Memorial Medical Center, Long Beach, CA, USA.'}, {'ForeName': 'Fasil', 'Initials': 'F', 'LastName': 'Tekola-Ayele', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Germaine M Buck', 'Initials': 'GMB', 'LastName': 'Louis', 'Affiliation': 'College of Health and Human Services, George Mason University, VA, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cuilin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. Electronic address: zhangcu@mail.nih.gov.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30024-3']
2874,32135138,"Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


In type 2 diabetes, long-acting GLP-1 receptor agonists lower fasting plasma glucose and improve glycaemic control via their insulinotropic and glucagonostatic effects. In type 1 diabetes, their efficacy as an add-on treatment to insulin therapy is modest. Short-acting GLP-1 receptor agonists also lower postprandial glucose excursions in type 2 diabetes by decelerating gastric emptying rate. We aimed to test the efficacy of a short-acting GLP-1 receptor agonist in type 1 diabetes.
METHODS


In the single-centre, parallel-group, randomised, double-blind, placebo-controlled MAG1C trial, patients with type 1 diabetes on multiple daily injection therapy aged 18 years and older with HbA 1c  59-88 mmol/mol (7·5-10·0%) and a BMI of more than 22·0 kg/m 2  were randomly assigned (1:1) through a computer-generated randomisation list to preprandial subcutaneous injection of 10 μg exenatide (Byetta) or placebo three times daily for 26 weeks as an add-on treatment to usual insulin therapy. Clinically assessed insulin titration was done by study staff. Participants and investigators were masked to treatment allocation. The primary endpoint was between-group difference in HbA 1c  after 26 weeks. Data were analysed with a baseline-adjusted linear mixed model in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03017352, and is completed.
FINDINGS


Between Jan 4, 2017, and Jan 16, 2019, 108 participants were randomly assigned, 54 to exenatide and 54 to placebo; 23 participants discontinued treatment (17 in the exenatide group and six in the placebo group). From a baseline-adjusted mean of 66·4 mmol/mol (95% CI 64·9-67·8 [8·2%, 8·1-8·4]), HbA 1c  changed by -3·2 mmol/mol (-5·0 to -1·4 [-0·3%, -0·5 to -0·1]) with exenatide and -2·1 mmol/mol (-3·7 to -0·6 [-0·2%, -0·3 to -0·1]) with placebo after 26 weeks (estimated treatment difference of -1·1 mmol/mol (-3·4 to 1·2 [-0·1%, -0·3 to 0·1]; p=0·36). Exenatide increased the number of self-reported gastrointestinal adverse events (primarily nausea [48 events among 37 patients with exenatide, nine with placebo among 9 patients]). Two serious adverse events occurred in the exenatide group, and six occurred in the placebo group (none were considered to be related to the study drug).
INTERPRETATION


Short-acting exenatide does not seem to have a future as a standard add-on treatment to insulin therapy in type 1 diabetes.
FUNDING


AstraZeneca.",2020,"Exenatide increased the number of self-reported gastrointestinal adverse events (primarily nausea [48 events among 37 patients with exenatide, nine with placebo among 9 patients]).","['Between Jan 4, 2017, and Jan 16, 2019', '108 participants', 'patients with type 1 diabetes on multiple daily injection therapy aged 18 years and older with HbA 1c  59-88 mmol/mol (7·5-10·0%) and a BMI of more than 22·0 kg/m 2', 'type 1 diabetes (MAG1C', '37 patients with']","['Short-acting GLP-1 receptor agonists', 'placebo-controlled MAG1C', 'placebo', 'exenatide (Byetta) or placebo three times daily for 26 weeks as an add-on treatment to usual insulin therapy', 'exenatide', 'Exenatide', 'exenatide and -2·1 mmol/mol (-3·7 to -0·6', 'short-acting GLP-1 receptor agonist', 'meal-time administration of short-acting exenatide', 'exenatide group and six in the placebo']","['Efficacy and safety', 'postprandial glucose excursions', 'number of self-reported gastrointestinal adverse events', 'adverse events']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",108.0,0.568872,"Exenatide increased the number of self-reported gastrointestinal adverse events (primarily nausea [48 events among 37 patients with exenatide, nine with placebo among 9 patients]).","[{'ForeName': 'Nicklas J', 'Initials': 'NJ', 'LastName': 'Johansen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Schlüntz', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Frandsen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Pedersen-Bjergaard', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Endocrinology and Nephrology, Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik U', 'Initials': 'HU', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: filip.krag.knop.01@regionh.dk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30030-9']
2875,31821592,Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study.,"OBJECTIVE


The objective of this study was to compare the relative effectiveness of dialectical behavior therapy guided self-help (DBT-GSH) and DBT unguided self-help (DBT-USH) with an unguided self-help control condition in the treatment of binge-eating disorder (BED).
METHOD


Seventy-one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview were randomly assigned to DBT-GSH, DBT-USH or active control USH for 12 weeks. Assessments took place at baseline, 12 weeks and 3-month follow-up. Outcome measures included the EDE to assess binge frequency, the EDE-Questionnaire (EDE-Q), the Brief Symptom Inventory, and the Short Form 6D.
RESULTS


The overall completion rate was 65% at post-treatment and 63% at 3-month follow-up. Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes. A similar pattern emerged for secondary outcome variables including eating disorder psychopathology, general psychological distress, and health-related quality of life.
DISCUSSION


Self-help may be an effective way to disseminate DBT for BED. However, future research should evaluate DBT self-help using a larger sample size, possibly in a multisite design.",2020,Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes.,"['binge-eating disorder', 'Seventy-one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview', 'binge-eating disorder (BED']","['DBT-GSH, DBT-USH or active control USH', 'Dialectical behavior therapy self-help', 'dialectical behavior therapy guided self-help (DBT-GSH) and DBT unguided self-help (DBT-USH', 'unguided self-help control condition']","['binge frequency', 'overall completion rate', 'eating disorder psychopathology, general psychological distress, and health-related quality of life', 'EDE to assess binge frequency, the EDE-Questionnaire (EDE-Q), the Brief Symptom Inventory, and the Short Form 6D']","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",71.0,0.0940335,Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes.,"[{'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Carter', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Therese E', 'Initials': 'TE', 'LastName': 'Kenny', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Singleton', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Van Wijk', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Heath', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}]",The International journal of eating disorders,['10.1002/eat.23208']
2876,31808986,"Carbonic anhydrase, obstructive sleep apnea and hypertension: Effects of intervention.","Whole blood carbonic anhydrase activity (CAa) is increased in patients with obstructive sleep apnea (OSA). Our study investigated the influence of positive airway pressure (PAP) or CA inhibitor acetazolamide (ACT) therapy on CAa, OSA and blood pressure. Thirty-three OSA patients (21 hypertensive, body mass index (BMI) 37 ± 7 kg/m 2  and apnea-hypopnea index (AHI) of 47 ± 31 events/hr) were followed-up after PAP treatment (compliance, 4.7 ± 1.5 hr/day; duration, median 6 [IQR 6,6] months) (Cohort A). A second OSA Cohort (B) contained nine hypertensive patients (BMI, 29 ± 4 kg/m 2  ; AHI, 39 ± 20 events/hr) with 2-week treatment of ACT, PAP or ACT + PAP in an open crossover study. CAa was assessed at baseline and at the end of each treatment period. In Cohort A, baseline CAa was higher in hypertensive, compared with normotensive, patients (1,033 ± 204 versus 861 ± 201 units, p = .028). PAP treatment reduced systolic/diastolic blood pressure but not CAa (-9 ± 11/-5 ± 7 mmHg and -20 ± 289 units, p < .001, <.001 and .70). In Cohort B, blood pressure was reduced in both ACT-treated groups (-10 ± 10/-5 ± 7 mmHg, p = .043 and .019; and -5 ± 5/-13 ± 13 mmHg, p < .001 and .009). AHI was reduced in both groups: ACT only, -17 ± 9 events/hr p = .001; and ACT + PAP, -39 ± 19 events/hr, p < .001. PAP did not change CAa (p = .98) but activity tended to decrease after ACT with or without PAP (p = .081 and .056). CAa is elevated in hypertensive OSA patients. Long-term PAP reduced blood pressure without affecting CAa. ACT reduced blood pressure and CAa. Increased CAa may constitute a physiological characteristic in OSA, contributing to comorbid hypertension.",2020,PAP did not change CAa (p = .98) but activity tended to decrease after ACT with or without PAP (p = .081 and .056).,"['Thirty-three OSA patients (21 hypertensive, body mass index', 'hypertensive OSA patients', 'patients with obstructive sleep apnea (OSA']","['ACT, PAP or ACT\xa0+\xa0PAP', 'positive airway pressure (PAP) or CA inhibitor acetazolamide (ACT) therapy']","['BMI] 37\xa0±\xa07\xa0kg/m 2  and apnea-hypopnea index [AHI] of 47\xa0±', 'systolic/diastolic blood pressure but not CAa (-9\xa0±', 'baseline CAa', 'Carbonic anhydrase, obstructive sleep apnea and hypertension', 'blood pressure', 'blood pressure and CAa', 'CAa, OSA and blood pressure', 'Whole blood carbonic anhydrase activity (CAa', 'AHI', 'CAa']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1842937', 'cui_str': 'Caa'}, {'cui': 'C0007028', 'cui_str': 'Carbonic Anhydrases'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",33.0,0.0160174,PAP did not change CAa (p = .98) but activity tended to decrease after ACT with or without PAP (p = .081 and .056).,"[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hoff', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Zou', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Schiza', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, Medical School, University of Crete, Heraklion, Greece.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Demir', 'Affiliation': 'Department of Chemistry, Faculty of Sciences, Atatürk University, Erzurum, Turkey.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Grote', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Izolde', 'Initials': 'I', 'LastName': 'Bouloukaki', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, Medical School, University of Crete, Heraklion, Greece.'}, {'ForeName': 'Şükrü', 'Initials': 'Ş', 'LastName': 'Beydemir', 'Affiliation': 'Department of Biochemistry, Faculty of Pharmacy, Anadolu University, Eskişehir, Turkey.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Eskandari', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Stenlöf', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12956']
2877,31903600,"Randomized clinical trial of continuous transversus abdominis plane block, epidural or patient-controlled analgesia for patients undergoing laparoscopic colorectal cancer surgery.","BACKGROUND


The optimal analgesia regimen after laparoscopic colorectal cancer surgery is unclear. The aim of the study was to characterize the beneficial effects of continuous transversus abdominis plane (TAP) blocks initiated before operation on outcomes following laparoscopic colorectal cancer surgery.
METHODS


Patients undergoing surgery for colorectal cancer were divided randomly into three groups: combined general-TAP anaesthesia (TAP group), combined general-thoracic epidural anaesthesia (TEA group) and standard general anaesthesia (GA group). The primary endpoint was duration of hospital stay. Secondary endpoints included gastrointestinal motility, pain scores and plasma levels of cytokines.
RESULTS


In total, 180 patients were randomized and 165 completed the trial. The intention-to-treat analysis showed that duration of hospital stay was significantly longer in the TEA group than in the TAP and GA groups (median 4·1 (95 per cent c.i. 3·8 to 4·3) versus 3·1 (3·0 to 3·3) and versus 3·3 (3·2 to 3·6) days respectively; both P < 0·001). Time to first flatus was earlier in the TAP group (P < 0·001). Visual analogue scale (VAS) scores during coughing were lower in the TAP and TEA groups than the GA group (P < 0·001). Raised plasma levels of vascular endothelial growth factor C, interleukin 6, adrenaline and cortisol were attenuated significantly by continuous TAP block.
CONCLUSION


Continuous TAP analgesia not only improved gastrointestinal motility but also shortened duration of hospital stay. A decreased opioid requirement and attenuating surgical stress response may be potential mechanisms. Registration number: ChiCTR-TRC-1800015535 ( http://www.chictr.org.cn).",2020,"Raised plasma levels of vascular endothelial growth factor C, interleukin 6, adrenaline and cortisol were attenuated significantly by continuous TAP block.
","['laparoscopic colorectal cancer surgery', '3·8 to 4·3) versus 3·1', '180 patients were randomized and 165 completed the trial', 'Patients undergoing surgery for colorectal cancer', 'patients undergoing laparoscopic colorectal cancer surgery']","['continuous transversus abdominis plane (TAP) blocks', 'TEA', 'continuous transversus abdominis plane block, epidural or patient-controlled analgesia', 'combined general-TAP anaesthesia (TAP group), combined general-thoracic epidural anaesthesia (TEA group) and standard general anaesthesia (GA group']","['Visual analogue scale (VAS) scores during coughing', 'gastrointestinal motility, pain scores and plasma levels of cytokines', 'Time to first flatus', 'Raised plasma levels of vascular endothelial growth factor C, interleukin 6, adrenaline and cortisol', 'gastrointestinal motility', 'duration of hospital stay']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0388911', 'cui_str': 'Vascular Endothelial Growth Factor C'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",180.0,0.143759,"Raised plasma levels of vascular endothelial growth factor C, interleukin 6, adrenaline and cortisol were attenuated significantly by continuous TAP block.
","[{'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Yin', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Weng', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Z R', 'Initials': 'ZR', 'LastName': 'Sun', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Miao', 'Affiliation': 'Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}]",The British journal of surgery,['10.1002/bjs.11403']
2878,32135136,Early detection of diabetic kidney disease by urinary proteomics and subsequent intervention with spironolactone to delay progression (PRIORITY): a prospective observational study and embedded randomised placebo-controlled trial.,"BACKGROUND


Microalbuminuria is an early sign of kidney disease in people with diabetes and indicates increased risk of cardiovascular disease. We tested whether a urinary proteomic risk classifier (CKD273) score was associated with development of microalbuminuria and whether progression to microalbuminuria could be prevented with the mineralocorticoid receptor antagonist spironolactone.
METHODS


In this multicentre, prospective, observational study with embedded randomised controlled trial (PRIORITY), we recruited people with type 2 diabetes, normal urinary albumin excretion, and preserved renal function from 15 specialist centres in ten European countries. All participants (observational cohort) were tested with the CKD273 classifier and classified as high risk (CKD273 classifier score >0·154) or low risk (≤0·154). Participants who were classified as high risk were entered into a randomised controlled trial and randomly assigned (1:1), by use of an interactive web-response system, to receive spironolactone 25 mg once daily or matched placebo (trial cohort). The primary endpoint was development of confirmed microalbuminuria in all individuals with available data (observational cohort). Secondary endpoints included reduction in incidence of microalbuminuria with spironolactone (trial cohort, intention-to-treat population) and association between CKD273 risk score and measures of impaired renal function based on estimated glomerular filtration rate (eGFR; observational cohort). Adverse events (particularly gynaecomastia and hyperkalaemia) and serious adverse events were recorded for the intention-to-treat population (trial cohort). This study is registered with the EU Clinical Trials Register (EudraCT 20120-004523-4) and ClinicalTrials.gov (NCT02040441) and is completed.
FINDINGS


Between March 25, 2014, and Sept 30, 2018, we enrolled and followed-up 1775 participants (observational cohort), 1559 (88%) of 1775 participants had a low-risk urinary proteomic pattern and 216 (12%) had a high-risk pattern, of whom 209 were included in the trial cohort and assigned to spironolactone (n=102) or placebo (n=107). The overall median follow-up time was 2·51 years (IQR 2·0-3·0). Progression to microalbuminuria was seen in 61 (28%) of 216 high-risk participants and 139 (9%) of 1559 low-risk participants (hazard ratio [HR] 2·48, 95% CI 1·80-3·42; p<0·0001, after adjustment for baseline variables of age, sex, HbA 1c , systolic blood pressure, retinopathy, urine albumin-to-creatinine ratio [UACR], and eGFR). Development of impaired renal function (eGFR <60 mL/min per 1·73 m 2 ) was seen in 48 (26%) of 184 high-risk participants and 119 (8%) of 1423 low-risk participants (HR 3·50; 95% CI 2·50-4·90, after adjustment for baseline variables). A 30% decrease in eGFR from baseline (post-hoc endpoint) was seen in 42 (19%) of 216 high-risk participants and 62 (4%) of 1559 low-risk participants (HR 5·15, 95% CI 3·41-7·76; p<0·0001, after adjustment for basline eGFR and UACR). In the intention-to-treat trial cohort, development of microalbuminuria was seen in 35 (33%) of 107 in the placebo group and 26 (25%) of 102 in the spironolactone group (HR 0·81, 95% CI 0·49-1·34; p=0·41). In the safety analysis (intention-to-treat trial cohort), events of plasma potassium concentrations of more than 5·5 mmol/L were seen in 13 (13%) of 102 participants in the spironolactone group and four (4%) of 107 participants in the placebo group, and gynaecomastia was seen in three (3%) participants in the spironolactone group and none in the placebo group. One patient died in the placebo group due to a cardiac event (considered possibly related to study drug) and one patient died in the spironolactone group due to cancer, deemed unrelated to study drug.
INTERPRETATION


In people with type 2 diabetes and normoalbuminuria, a high-risk score from the urinary proteomic classifier CKD273 was associated with an increased risk of progression to microalbuminuria over a median of 2·5 years, independent of clinical characteristics. However, spironolactone did not prevent progression to microalbuminuria in high-risk patients.
FUNDING


European Union Seventh Framework Programme.",2020,"Development of impaired renal function (eGFR <60 mL/min per 1·73 m 2 ) was seen in 48 (26%) of 184 high-risk participants and 119 (8%) of 1423 low-risk participants (HR 3·50; 95% CI 2·50-4·90, after adjustment for baseline variables).","['Participants who were classified as high risk', 'recruited people with type 2 diabetes, normal urinary albumin excretion, and preserved renal function from 15 specialist centres in ten European countries', 'Between March 25, 2014, and Sept 30, 2018, we enrolled and followed-up 1775 participants (observational cohort), 1559 (88%) of 1775 participants had a low-risk urinary proteomic pattern and 216 (12%) had a high-risk pattern, of whom 209 were included in the trial cohort and assigned to', 'people with diabetes']","['placebo', 'spironolactone 25 mg once daily or matched placebo', 'spironolactone']","['development of confirmed microalbuminuria', 'Progression to microalbuminuria', 'reduction in incidence of microalbuminuria with spironolactone (trial cohort, intention-to-treat population) and association between CKD273 risk score and measures of impaired renal function', 'cardiac event', 'eGFR', 'urinary proteomic risk classifier (CKD273) score', 'Adverse events (particularly gynaecomastia and hyperkalaemia) and serious adverse events', 'gynaecomastia', 'systolic blood pressure, retinopathy, urine albumin-to-creatinine ratio [UACR], and eGFR', 'plasma potassium concentrations', 'progression to microalbuminuria']","[{'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.573791,"Development of impaired renal function (eGFR <60 mL/min per 1·73 m 2 ) was seen in 48 (26%) of 184 high-risk participants and 119 (8%) of 1423 low-risk participants (HR 3·50; 95% CI 2·50-4·90, after adjustment for baseline variables).","[{'ForeName': 'Nete', 'Initials': 'N', 'LastName': 'Tofte', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindhardt', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Adamova', 'Affiliation': 'University Clinic of Endocrinology, Diabetes and Metabolic Disorders, Skopje, Macedonia.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Beige', 'Affiliation': 'Division of Nephrology and KfH Renal Unit, Hospital St Georg, Leipzig, Germany; Martin-Luther University Halle, Wittenberg, Germany.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology, and Nephrology, University Hospital Tübingen, Tübingen, Germany; Institute for Diabetes Research and Metabolic Diseases, Helmholtz Center Munich at Eberhard Karls University of Tübingen, Tübingen, Germany; German Center for Diabetes Research, Neuherberg, Germany.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Currie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Delles', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Dimos', 'Affiliation': 'Diabetespraxis, Leipzig, Germany.'}, {'ForeName': 'Lidmila', 'Initials': 'L', 'LastName': 'Francová', 'Affiliation': '1st Department, Charles University, Third Faculty of Medicine, Prague, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Frimodt-Møller', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Girman', 'Affiliation': 'Diabetes Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Göke', 'Affiliation': 'Diabetologische Schwerpunktpraxis, Diabetologen Hessen, Marburg, Germany.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Havrdova', 'Affiliation': 'Diabetes Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Kooy', 'Affiliation': 'Bethesda Diabetes Research Center, Hoogeveen, Netherlands; Diabetes Vascular Research Foundation (DVRF), Hoogeveen, Netherlands; University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine/Nephrology, Ziekenhuisgroep Twente Hospital, Almelo, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mischak', 'Affiliation': 'Mosaiques Diagnostics, Hannover, Germany.'}, {'ForeName': 'Gerjan', 'Initials': 'G', 'LastName': 'Navis', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Giel', 'Initials': 'G', 'LastName': 'Nijpels', 'Affiliation': 'Department General Practice and Elderly Care, Amsterdam, Netherlands.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Noutsou', 'Affiliation': 'Diabetes Center, 2nd Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Hippokratio General Hospital, Athens, Greece.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Instituto de Investigacion Sanitaria de la Fundacion Jiménez Díaz UAM, Madrid, Spain.'}, {'ForeName': 'Aneliya', 'Initials': 'A', 'LastName': 'Parvanova', 'Affiliation': 'Department of Renal Medicine, Clinical Research Centre for Rare Diseases ""Aldo e CeleDaccò"": Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica, Bergamo, Italy.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Piero L', 'Initials': 'PL', 'LastName': 'Ruggenenti', 'Affiliation': 'Department of Renal Medicine, Clinical Research Centre for Rare Diseases ""Aldo e CeleDaccò"": Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica, Bergamo, Italy.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Rutters', 'Affiliation': 'Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rychlík', 'Affiliation': '1st Department, Charles University, Third Faculty of Medicine, Prague, Czech Republic; Faculty Hospital Královské Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Siwy', 'Affiliation': 'Mosaiques Diagnostics, Hannover, Germany.'}, {'ForeName': 'Goce', 'Initials': 'G', 'LastName': 'Spasovski', 'Affiliation': 'Department of Nephrology, Cyril and Methodius University in Skopje, Skopje, North Macedonia.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Speeckaert', 'Affiliation': 'Department of Nephrology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Trillini', 'Affiliation': 'Department of Renal Medicine, Clinical Research Centre for Rare Diseases ""Aldo e CeleDaccò"": Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica, Bergamo, Italy.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zürbig', 'Affiliation': 'Mosaiques Diagnostics, Hannover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Hannover Clinical Trial Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; University of Copenhagen, Copenhagen, Denmark. Electronic address: peter.rossing@regionh.dk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30026-7']
2879,32128909,Cancer worry and empathy moderate the effect of a survivorship-focused intervention on quality of life.,"OBJECTIVE


This study examined the impact of a survivorship planning consultation (SPC) for patients with Hodgkin's lymphoma and diffuses large B-cell lymphoma on quality of life (QOL). We specifically assessed two potential moderators, cancer worry and perceived empathy, of the intervention effects on QOL.
METHODS


This cluster randomized, four-site trial examined the efficacy of a SPC; physicians received communication skills training and applied these skills in a survivorship-focused office visit using a care plan vs a control arm in which physicians were trained to and subsequently provided a time-controlled, manualized wellness rehabilitation consultation focused only on discussion of healthy nutrition and exercise. We examined the effect of the intervention on patients' QOL and examined potential moderators-cancer worry and perceived physician empathy.
RESULTS


Forty-two physicians and 198 patients participated. There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10). However, cancer worry was a significant moderator of the effects of the intervention on three QOL domains (physical P = .04; social P = .04; spiritual P = .01) and perceived empathy was a significant moderator of QOL (physical P = .004; psychological P = .04; social P = .01). Specifically, the beneficial effects of the intervention were more pronounced among patients who initially reported higher levels of cancer worry and lower levels of physician empathy.
CONCLUSIONS


This study identified two factors, perceived empathy and cancer worry, that were found to impact the QOL of patients who participated in this communication-based survivorship intervention.",2020,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"['Forty-two physicians and 198 patients participated', ""patients with Hodgkin's lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL"", 'patients who participated in this communication-based survivorship intervention']","['manualized Wellness Rehabilitation Consultation (WRC) focused only on discussion of healthy nutrition and exercise', 'survivorship planning consultation (SPC', 'communication skills training']","['QOL dimensions', 'quality of life', 'cancer worry and lower levels of physician empathy', 'quality of life (QOL']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038955'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038955'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",198.0,0.0188331,There was no main effect of the intervention on any of the QOL dimensions (ps > 0.10).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Smita C', 'Initials': 'SC', 'LastName': 'Banerjee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Matasar', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Cancer Control & Population Sciences, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Astrow', 'Affiliation': 'Department of Medicine, New York Methodist Hospital, Hematology and Oncology, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leventhal', 'Affiliation': 'Department of Psychology, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kissane', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}]",Psycho-oncology,['10.1002/pon.5371']
2880,32151220,Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery.,"Background Laboratory studies demonstrate glucose-insulin-potassium (GIK) as a potent cardioprotective intervention, but clinical trials have yielded mixed results, likely because of varying formulas and timing of GIK treatment and different clinical settings. This study sought to evaluate the effects of modified GIK regimen given perioperatively with an insulin-glucose ratio of 1:3 in patients undergoing cardiopulmonary bypass surgery. Methods and Results In this prospective, randomized, double-blinded trial with 930 patients referred for cardiac surgery with cardiopulmonary bypass, GIK (200 g/L glucose, 66.7 U/L insulin, and 80 mmol/L KCl) or placebo treatment was administered intravenously at 1 mL/kg per hour 10 minutes before anesthesia and continuously for 12.5 hours. The primary outcome was the incidence of in-hospital major adverse cardiac events including all-cause death, low cardiac output syndrome, acute myocardial infarction, cardiac arrest with successful resuscitation, congestive heart failure, and arrhythmia. GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group. Mechanistically, this treatment resulted in increased glucose uptake and less lactate excretion calculated by the differences between arterial and coronary sinus, and increased phosphorylation of insulin receptor substrate-1 and protein kinase B in the hearts of GIK-treated patients. Systemic blood lactate was also reduced in GIK-treated patients during cardiopulmonary bypass surgery. Conclusions A modified GIK regimen administered perioperatively reduces the incidence of in-hospital major adverse cardiac events in patients undergoing cardiopulmonary bypass surgery. These benefits are likely a result of enhanced systemic tissue perfusion and improved myocardial metabolism via activation of insulin signaling by GIK. Clinical Trial Registration URL: clinicaltrials.gov. Identifier: NCT01516138.",2020,GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group.,"['patients undergoing cardiopulmonary bypass surgery', '930 patients referred for cardiac surgery with cardiopulmonary bypass, GIK (200 g/L glucose, 66.7 U/L insulin, and 80 mmol/L KCl) or', 'Patients Undergoing Cardiopulmonary Bypass Surgery']","['GIK therapy', 'placebo', 'Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection', 'glucose-insulin-potassium (GIK', 'modified GIK regimen']","['Systemic blood lactate', 'incidence of in-hospital major adverse cardiac events including all-cause death, low cardiac output syndrome, acute myocardial infarction, cardiac arrest with successful resuscitation, congestive heart failure, and arrhythmia', 'incidence of in-hospital major adverse cardiac events', 'incidence of major adverse cardiac events', 'glucose uptake and less lactate excretion', 'phosphorylation of insulin receptor substrate-1 and protein kinase B']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0340514', 'cui_str': 'Cardiac arrest with successful resuscitation (disorder)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}, {'cui': 'C0164786', 'cui_str': 'Proto-Oncogene Proteins c-akt'}]",930.0,0.212401,GIK therapy reduced the incidence of major adverse cardiac events and enhanced cardiac function recovery without increasing perioperative blood glucose compared with the control group.,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Ultrasonic Diagnosis Xijing Hospital Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""School of Aerospace Medicine Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Cui', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Bijun', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': ""Department of Health Statistics and Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Xin-Liang', 'Initials': 'XL', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency Medicine Thomas Jefferson University Philadelphia PA.'}, {'ForeName': 'Shiqiang', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Dinghua', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Department of Cardiovascular Surgery Fourth Military Medical University Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""School of Aerospace Medicine Fourth Military Medical University Xi'an, China.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.012376']
2881,31636172,Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.,"Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo ( P  < 0.001) irrespective of CAD genetic risk ( P   interaction  > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.",2020,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P   int >0.05).,"['2,658 Diabetes Prevention Program participants', 'individuals with dysglycemia']","['placebo', 'metformin']","['CAD genetic risk', 'majority of recognized CRFs', 'Coronary artery disease (CAD', 'PRS and dietary quality and physical activity on one-year change in body mass index, fasting glucose, triglycerides, and HDLc']","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",2658.0,0.0257923,Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared to placebo ( P <0.001) irrespective of CAD genetic risk ( P   int >0.05).,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Merino', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Jablonski', 'Affiliation': 'The Biostatistics Center, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Mercader', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Genomics Platform, Eli and Edythe L. Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Maria Rosario G', 'Initials': 'MRG', 'LastName': 'Araneta', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Suzanne B R', 'Initials': 'SBR', 'LastName': 'Jacobs', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Uzoma N', 'Initials': 'UN', 'LastName': 'Ibebuogu', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, The University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Genetic & Molecular Epidemiology Unit, Lund University Diabetes Centre, Malmo, Sweden.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0097']
2882,32149456,Effects of Group-Based Exercise on Flourishing and Stigma Consciousness among Older Adults: Findings from a Randomised Controlled Trial.,"BACKGROUND


To examine the extent to which group-based exercise programs, informed by self-categorisation theory, result in improvements in psychological flourishing and reductions in age- and gender-related stigma consciousness among older adults.
METHODS


In the study, older adults (N = 485, ≥ 65 years) were randomised to similar age same gender (SASG), similar age mixed gender (SAMG), or ""standard"" mixed age mixed gender (MAMG) group-based exercise programs. Flourishing and stigma consciousness were assessed on six occasions during the 24-week intervention and represented secondary trial outcomes. Multilevel growth models examined the effects of the interventions on flourishing and stigma consciousness over time.
RESULTS


Participants in the SASG and SAMG conditions demonstrated, on average, higher levels of flourishing, relative to the MAMG condition, over the course of the 24 weeks (p < .05). Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05). No time by group interaction effects were observed for either flourishing or stigma consciousness.
CONCLUSIONS


The results provide some support for the utility of group exercise programs, informed by self-categorisation theory, to enhance psychological flourishing and reduce stigma consciousness among older adults.",2020,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","['older adults (N\xa0=\xa0485, ≥ 65\xa0years', 'Older Adults', 'older adults']","['standard"" mixed age mixed gender (MAMG) group-based exercise programs', 'Group-Based Exercise']","['flourishing or stigma consciousness', 'Flourishing and stigma consciousness', 'Flourishing and Stigma Consciousness', 'stigma consciousness', 'flourishing and stigma consciousness', 'lower levels of age- and gender-related stigma consciousness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",,0.0385621,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","[{'ForeName': 'Geralyn R', 'Initials': 'GR', 'LastName': 'Ruissen', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Schmader', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Harden', 'Affiliation': 'Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Svenja A', 'Initials': 'SA', 'LastName': 'Wolf', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, Canada.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dunlop', 'Affiliation': 'University of California, Riverside, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Bruno D', 'Initials': 'BD', 'LastName': 'Zumbo', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12197']
2883,31342226,Probiotics modulate the gut microbiota composition and immune responses in patients with atopic dermatitis: a pilot study.,"PURPOSE


Many studies have investigated the association between intestinal barrier impairment and the onset of atopic dermatitis (AD). The gut microbiota is essential to maintain physiological homeostasis and immune regulation of host. Therefore, the objectives were to determine the effects of probiotics on the clinical symptoms, immune responses, and gut microbiota in AD patients.
METHODS


109 patients were randomly divided into 4 groups, including placebo group, oligosaccharides group, Bifidobacterium bifidum CCFM16 group, and Lactobacillus plantarum CCFM8610 group. At the end of the experiment, serological indicators, SCORAD, and DLQI indices were assessed. V3-V4 region of the 16S ribosomal RNA gene was sequenced to evaluate changes in the gut microbiota. Linear discriminant analysis (LDA) effect size was used to uncover microbial biomarkers and PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) was used to predict gene family abundances based on 16S information.
RESULTS


The results demonstrated that CCFM8610 significantly decreased the SCORAD index, and increased the serum IL-10 levels. Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio. CCFM8610 treatment downregulated the functional genes of gut microbiota involving Staphylococcus aureus infection and upregulated the steroid hormone biosynthesis.
CONCLUSION


The results indicated a positive correlation between decreased SCORAD index and CCFM8610 treatment, and that CCFM8610 regulated the immune responses in AD patients. CCFM8610 treatment influences the gut microbiota composition and functional changes. In conclusion, L. plantarum CCFM8610 exerts the strain-specific amelioration effects on patients with AD.
TRIAL REGISTRATION


ChiCTR1800015330 (Clinicaltrials.gov Identifier).",2020,"Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio.","['patients with AD', 'AD patients', '109 patients', 'patients with atopic dermatitis']","['Probiotics', 'CCFM8610', 'CCFM8610 and CCFM16', 'placebo group, oligosaccharides group, Bifidobacterium bifidum CCFM16 group, and Lactobacillus plantarum CCFM8610 group', 'L. plantarum CCFM8610']","['SCORAD index', 'serological indicators, SCORAD, and DLQI indices', 'proportion of Bacteroidetes, and reduced the F/B ratio', 'alpha diversity', 'gut microbiota composition and functional changes', 'gut microbiota composition and immune responses', 'strain-specific amelioration effects', 'serum IL-10 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",109.0,0.0290228,"Supplement with CCFM8610 and CCFM16 significantly influenced the alpha diversity, increased the proportion of Bacteroidetes, and reduced the F/B ratio.","[{'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China. luwenwei@jiangnan.edu.cn.'}, {'ForeName': 'Jianxian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""The Tinghu People's Hospital, Yancheng, 224002, Jiangsu, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""The Tinghu People's Hospital, Yancheng, 224002, Jiangsu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, 214122, Jiangsu, China. weichen@jiangnan.edu.cn.'}]",European journal of nutrition,['10.1007/s00394-019-02061-x']
2884,31342228,Long-term dietary adherence and changes in dietary intake in coronary patients after intervention with a Mediterranean diet or a low-fat diet: the CORDIOPREV randomized trial.,"PURPOSE


Adherence to a healthy dietary pattern positively influences clinical outcomes in cardiovascular prevention, but long-term adherence is difficult to maintain. We evaluated 5-year changes in dietary habits, adherence achieved, and its maintenance in a cohort of coronary patients from the CORDIOPREV study.
METHODS


1002 coronary patients were randomized to a Mediterranean diet (n = 502) or a low-fat diet (n = 500) and received individual-group-telephone visits and personalized dietary advice. A validated food-frequency questionnaire, a 14-point Mediterranean diet adherence screener, and a 9-point low-fat diet adherence score were used. Dietary adherence was categorized into Low, Medium, and High Adherence. Changes in nutrient intake, food consumption, and adherence were analyzed on a yearly basis. The maintenance of long-term dietary adherence was evaluated using data after the first year and fifth year.
RESULTS


From baseline to 5 years, significant increases were observed in overall dietary adherence (Mediterranean diet from 8.9 to 11.4; low-fat diet from 3.9 to 7.1) and in the percentage of patients considered High Adherence (Mediterranean diet from 41 to 89%; low-fat diet from 4 to 67%). When we evaluated the maintenance of adherence, patients considered Low and Medium Adherence at 1 year increased their adherence at the 5 years with both diets and patients considered High Adherence maintained their adherence with a Mediterranean diet, but decreased their adherence with a low-fat diet.
CONCLUSIONS


A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets. In our population, the Mediterranean diet group achieved a high level of adherence in the short term which was maintained in the long term.",2020,A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets.,"['coronary patients after intervention with a Mediterranean diet or a low-fat diet', '1002 coronary patients']","['Mediterranean diet', 'Mediterranean diet (n\u2009=\u2009502) or a low-fat diet (n\u2009=\u2009500) and received individual-group-telephone visits and personalized dietary advice']","['level of adherence', 'maintenance of long-term dietary adherence', 'nutrient intake, food consumption, and adherence', 'dietary intake', 'overall dietary adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1002.0,0.0174968,A comprehensive dietary intervention results in an overall long-term improvement and maintenance of adherence to the Mediterranean and low-fat diets.,"[{'ForeName': 'Gracia Maria', 'Initials': 'GM', 'LastName': 'Quintana-Navarro', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Alcala-Diaz', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Moreno', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Perez-Corral', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Leon-Acuña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Jose David', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Oriol Alberto', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Antonio Pablo', 'Initials': 'AP', 'LastName': 'Arenas de Larriva', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Corina', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Camargo', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Elena Maria', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodriguez-Cantalejo', 'Affiliation': 'Biochemical Laboratory, Reina Sofia University Hospital, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Raul Miguel', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'Department of Cell Biology, Physiology, and Immunology, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Av. Menendez Pidal s/n, 14004, Cordoba, Spain. delgadolista@gmail.com.'}]",European journal of nutrition,['10.1007/s00394-019-02059-5']
2885,32195897,Rapid Advancement in Enteral Nutrition Does Not Affect Systemic Inflammation and Insulin Homeostasis Following Pediatric Cardiopulmonary Bypass Surgery.,"OBJECTIVES


To determine impact of enteral nutrition delivery on the relationship among inflammation, insulin resistance, and outcomes following pediatric cardiopulmonary bypass surgery.
DESIGN


Pilot, randomized study analyzed according to intention-to-treat analysis.
SETTING


Pediatric cardiac ICU.
PATIENTS


Infants (≤ 6 mo) undergoing cardiopulmonary bypass.
INTERVENTIONS


Patients randomly assigned to receive rapid escalation to enteral nutrition reaching goal feeds by 27 hours or standard feeding practice reaching goal feeds by 63 hours. Feeds were initiated on the first postoperative day.
MEASUREMENTS AND MAIN RESULTS


Fifty patients were randomized equally to study arms. Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min). Serial blood samples were drawn before and after cardiopulmonary bypass, cardiac ICU admission, and every 12 hours (up to 96 hr) for glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels. Glucose-insulin ratio was calculated to quantify insulin resistance. Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration were similar across intervention arms. FF reached goal feeds at similar intervals as standard feeding (39 hr [30-60 hr] vs 60 hr [21-78 hr]; p = 0.75). No difference in cytokine, insulin, or glucose-insulin ratio was noted between groups. Higher inflammation was associated with increased glucose-insulin ratio and higher risk of adverse events. In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013). Although higher interleukin-8 was associated with an elevated risk of adverse event, this relationship was possibly mitigated by FF (odds ratio [95% CI], 0.086 [0.002-1.638]; p = 0.13).
CONCLUSIONS


A FF strategy was not associated with changes to early enteral nutrition delivery. Inflammation, insulin resistance, and morbidity were similar, but FF may modify the relationship between inflammation and adverse event. Multicenter nutrition studies are possible and necessary in this vulnerable population.",2020,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","['Infants (≤ 6 mo) undergoing cardiopulmonary bypass', 'Fifty patients', 'Pediatric Cardiopulmonary Bypass Surgery', 'Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min', 'pediatric cardiopulmonary bypass surgery']",['enteral nutrition delivery'],"['Systemic Inflammation and Insulin Homeostasis', 'cytokine, insulin, or glucose-insulin ratio', 'Glucose-insulin ratio', 'Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration', 'glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels', 'Inflammation, insulin resistance, and morbidity', 'glucose-insulin ratio and higher risk of adverse events', 'glucose-insulin ratio']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.273371,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","[{'ForeName': 'Alejandro A', 'Initials': 'AA', 'LastName': 'Floh', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Herridge', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Chun-Po S', 'Initials': 'CS', 'LastName': 'Fan', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiology, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Van Arsdell', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiovascular Surgery, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Balmer-Minnes', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Schwartz', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002314']
2886,32044755,Improving Calcium Knowledge and Intake in Young Adults Via Social Media and Text Messages: Randomized Controlled Trial.,"BACKGROUND


Calcium is an important nutrient for the attainment of peak bone mass during adolescence and young adulthood. However, these life phases are characterized as hard to reach for health promotion. Social media platforms offer a promising channel as they are relatively low cost but used ubiquitously by youth.
OBJECTIVE


The aim of the CAlcium Nutrition-Dietary Opportunities (CAN-DO) study was to conduct a randomized controlled trial to test the effectiveness of Facebook alone or with text messaging as channels to deliver a theory-based program to encourage optimal calcium intake.
METHODS


The intervention was a 3-arm parallel trial. Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial. Participants were randomized to 1 of the 3 arms (ie, Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake). The primary outcome was change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods. Changes were assessed before and after the intervention, and the differences in change between groups were compared using multivariate regression models with multiple imputations for missing data.
RESULTS


A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study. At the end of the program, no increase in milk intake (odds ratio [OR] 1.51, 95% CI 0.61-3.75 Facebook; OR 1.77, 95% CI 0.74-4.24 Facebook plus text messages; P=.41) nor calcium-rich food was detected (P=.57). There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01). Our results showed a moderate level of engagement with intervention content and positive qualitative feedback from participants.
CONCLUSIONS


The CAN-DO study delivered via Facebook (with the additional support of text messages) was found to improve knowledge and was acceptable among young adults. However, further research is needed to better understand social media engagement and how to optimize the program for participants to be sufficiently motivated to increase their intake of calcium-rich foods.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12620000097943; http://www.anzctr.org.au/ACTRN12620000097943.aspx.",2020,"There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01).","['Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial', 'young adults', 'A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study', 'Young Adults']","['Facebook alone or with text messaging', 'CAlcium Nutrition-Dietary Opportunities (CAN-DO', 'Via Social Media and Text Messages', 'Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake']","['habit formation', 'milk intake', 'change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods', 'knowledge']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0453861', 'cui_str': 'Rich food (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",211.0,0.179575,"There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01).","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Rouf', 'Affiliation': 'The University of Sydney, School of Life and Environmental Sciences, Camperdown, Australia.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Nour', 'Affiliation': 'The University of Sydney, School of Life and Environmental Sciences, Camperdown, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Allman-Farinelli', 'Affiliation': 'The University of Sydney, School of Life and Environmental Sciences, Camperdown, Australia.'}]",JMIR mHealth and uHealth,['10.2196/16499']
2887,32022771,One-year Results of a Factorial Randomized Trial of Aspirin versus Placebo and Clonidine versus Placebo in Patients Having Noncardiac Surgery.,"BACKGROUND


The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown.
METHODS


The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h.
RESULTS


Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
CONCLUSIONS


Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect.",2020,"There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
","['Patients Having Noncardiac Surgery', 'patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr', '10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to', 'patients with previous percutaneous coronary intervention']","['Placebo', 'aspirin or placebo', 'Aspirin', 'clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo', 'Perioperative aspirin', 'clonidine or placebo', 'clonidine', 'aspirin and/or clonidine', 'Placebo and Clonidine', 'aspirin']","['hazard ratio', 'risk of major bleeding and clonidine caused hypotension and bradycardia', 'death, cardiovascular complications, cancer, or chronic incisional pain', 'nonfatal myocardial infarctions and/or deaths', 'composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin', 'death or nonfatal infarction', 'death and nonfatal myocardial infarction', 'perioperative bleeding, and clonidine provoked hypotension and bradycardia', '30-day composite of nonfatal myocardial infarction or death', 'infarctions or deaths', 'nonfatal myocardial infarction or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",10010.0,0.539866,"There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1).
","[{'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ""From the Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio (D.I.S., A.K., A.T.) Population Health Research Institute (D.I.S., D.C., S.Y., Y.L.M., A.L., K.B., S.P., P.J.D.) Department of Medicine (D.C., S.Y., G.G., P.J.D.) Department of Health Research Methods, Evidence, and Impact (D.C., S.Y., G.G., Y.L.M., A.L., P.J.D.) Faculty of Health Sciences, Department of Anesthesia (Y.L.M.) Department of Surgery (R.W., A.L.), McMaster University, Hamilton, Ontario, Canada Department of Anaesthesia and Pain Management, Royal Melbourne Hospital and Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia (K.L.) Public Health and Clinical Epidemiology-Iberoamerican Cochrane Centre, Barcelona, Spain (E.P.) University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (M.G.) Department of Research, Foundation for Pediatric Cardiology, Institute of Cardiology and Faculty of Health Sciences (Departamento de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología and Facultad de Ciencias de la Salud), Universidad Autónoma de Bucaramanga, Colombia (J.C.V.) University of Western Ontario, London, Ontario, Canada (M.M.) Department of Clinical Research, Narayana Hrudayalaya Limited, Bangalore, India (A.S.) University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa (B.M.B.) Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark (C.S.M.) Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Canada (J.L.P., I.G.) St. John's Medical College and Research Institute, Bangalore, Karnataka, India (D.X.) Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong (M.T.V.C.) University of North Carolina School of Medicine, Chapel Hills, North Carolina (P.A.K.) NHS Grampian and the University of Aberdeen, Aberdeen, United Kingdom (P.F.) Knowledge and Evidence Unite (Unidad de Conocimiento y Evidencia), Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.) Department of Anaesthesia, Intensive Care, and Pain Medicine, Medical University of Vienna, Vienna, Austria (E.F.) Shifa International Hospitals, Islamabad, Pakistan (M.A.) University of the Andes and Santa Maria Clinic (Universidad de Los Andes and Clinica Santa María), Santiago, Chile (D.T.) Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.) Biomedical Research Institute (IIB - Sant Pau), Barcelona, Spain (P.P.) Hospital Israelita Albert Einstein, São Paulo, Brazil (O.B.) Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada (S.S.) Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute and Vita-Salute University, Milan, Italy (G.L.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': ''}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': ''}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Popova', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': ''}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Mrkobrada', 'Affiliation': ''}, {'ForeName': 'Alben', 'Initials': 'A', 'LastName': 'Sigamani', 'Affiliation': ''}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Biccard', 'Affiliation': ''}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': ''}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Parlow', 'Affiliation': ''}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ''}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Priya A', 'Initials': 'PA', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': ''}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Amir', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Paniagua', 'Affiliation': ''}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': ''}, {'ForeName': 'Sadeesh', 'Initials': 'S', 'LastName': 'Srinathan', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ''}, {'ForeName': 'Yannick Le', 'Initials': 'YL', 'LastName': 'Manach', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': ''}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Balasubramanian', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilron', 'Affiliation': ''}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Pettit', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003158']
2888,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE


To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS


As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS


There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION


Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
2889,31571128,"Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial.","BACKGROUND AND OBJECTIVE


Vertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with substantial impairment of health-related quality of life for the affected patients. Betahistine, a structural analogue of histamine and presumably the most widely prescribed anti-vertigo drug worldwide, has previously been shown to be an effective and safe treatment for these patients. The objective of the present study was to evaluate whether the fixed combination of cinnarizine and dimenhydrinate (Arlevert ® ) is non-inferior and thus a potentially useful alternative to betahistine dihydrochloride in the treatment of patients suffering from peripheral vestibular vertigo.
METHODS


In this prospective, multicenter, double-blind, randomized, non-inferiority clinical trial, outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia were randomly assigned to receive three times daily one tablet of either the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg or betahistine dihydrochloride 16 mg for 4 weeks. Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS). The non-inferiority margin was set to 0.3. Secondary outcomes included the patient's and investigator's judgment of global efficacy, the patient's rating of impairment of daily activities, and safety/tolerability of the treatments.
RESULTS


Three hundred and six patients (mean age 53.5 years, approximately 60% female) were enrolled and randomized to the fixed combination cinnarizine/dimenhydrinate (n = 152) or betahistine (n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively) were valid for the per-protocol analysis, which was used for the non-inferiority analysis. Treatment with cinnarizine/dimenhydrinate led to a stronger reduction of the MVS [least squares mean (LSM)] after 4-week therapy (primary endpoint) in comparison to betahistine (0.395 vs 0.488; difference: - 0.093, 95% CI - 0.180; - 0.007, p = 0.035); since the upper limit of the two-sided 95% confidence interval was not only below the non-inferiority margin of 0.3, but also entirely below 0, superiority of the fixed combination could be demonstrated. The combination preparation was also more effective after 1 week of therapy and received more favorable patient's ratings on overall efficacy and impairment of daily activities. Both treatments were very well tolerated. Only 12 patients (3.92%) reported 13 non-serious adverse events; 2 cinnarizine/dimenhydrinate-treated patients discontinued the study prematurely due to adverse events as compared to 5 betahistine-treated patients.
CONCLUSION


The fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg was found to be not only non-inferior, but superior to betahistine 16 mg in the improvement of peripheral vestibular vertigo. Furthermore, taking into account a good and slightly favorable safety profile, the present study provides evidence that the fixed-combination preparation is a potent and even superior alternative to betahistine in the treatment of vertigo related to peripheral vestibular disorders.
STUDY REGISTRATION


EudraCT No. 2011-004025-27.",2019,"Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS).","['n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively', 'patients suffering from peripheral vestibular vertigo', 'Patients with Peripheral Vestibular Vertigo', 'Three hundred and six patients (mean age 53.5 years, approximately 60% female', 'outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia']","['cinnarizine and dimenhydrinate (Arlevert ® ', 'betahistine', 'dihydrochloride', 'cinnarizine 20\xa0mg/dimenhydrinate 40\xa0mg or betahistine', 'Cinnarizine 20\xa0mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16', 'cinnarizine', 'Betahistine', 'cinnarizine 20 mg and dimenhydrinate', 'cinnarizine/dimenhydrinate', 'betahistine dihydrochloride', 'EudraCT']","['overall efficacy and impairment of daily activities', 'tolerated', '13 non-serious adverse events', '5-point visual analogue scale (VAS', 'peripheral vestibular vertigo', 'MVS [least squares mean (LSM', 'Efficacy and Safety', 'reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement', ""patient's and investigator's judgment of global efficacy, the patient's rating of impairment of daily activities, and safety/tolerability of the treatments""]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0155501', 'cui_str': 'Vertigo, Peripheral'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1274038', 'cui_str': 'Ear, nose and throat surgery'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}]","[{'cui': 'C0008803', 'cui_str': 'Cinnarizine'}, {'cui': 'C0012381', 'cui_str': 'Dimenhydrinate'}, {'cui': 'C0915717', 'cui_str': 'Arlevert'}, {'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}, {'cui': 'C0282071', 'cui_str': 'Betahistine Hydrochloride'}, {'cui': 'C1959890', 'cui_str': 'Cinnarizine / Dimenhydrinate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0155501', 'cui_str': 'Vertigo, Peripheral'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427108', 'cui_str': 'General unsteadiness (finding)'}, {'cui': 'C0701824', 'cui_str': 'Staggering gait (finding)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",306.0,0.14764,"Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS).","[{'ForeName': 'Arne W', 'Initials': 'AW', 'LastName': 'Scholtz', 'Affiliation': 'ENT Clinic, Medical University of Innsbruck, and ENT Center for Vertigo, Innsbruck, Austria.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'ENT Clinic, 3rd Medical Faculty, Charles University of Prague, Prague, Czech Republic.'}, {'ForeName': 'Bohdana', 'Initials': 'B', 'LastName': 'Stefflova', 'Affiliation': 'ENT Clinic, Regional Hospital Budweis, Budweis, Czech Republic.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Medzhidieva', 'Affiliation': 'ENT Clinic, Medical University of Sofia-St. Ivan Rilski Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Sergey V', 'Initials': 'SV', 'LastName': 'Ryazantsev', 'Affiliation': 'Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech, St. Petersburg, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Paschinin', 'Affiliation': 'North West State Medical University n. a. I.I. Mechnikov of Ministry of Health and Social Development, St. Petersburg, Russia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kunelskaya', 'Affiliation': 'Moscow Research-Practical Center of Otolaryngology n. a. L. I. Sverzhevsky, Moscow, Russia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Schumacher', 'Affiliation': 'Berlin-Chemie AG/Menarini, Berlin, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Weisshaar', 'Affiliation': 'Hennig Arzneimittel, Flörsheim am Main, Germany. gerhard.weisshaar@hennig-am.de.'}]",Clinical drug investigation,['10.1007/s40261-019-00858-6']
2890,31376501,The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression.,"OBJECTIVE


An adaptation of Parent-Child Interaction Therapy (PCIT) with a novel Emotion Development (ED) module has shown efficacy for the treatment of early childhood depression. Children who received PCIT-ED also showed healthy alterations in neural response to reward. We investigated whether the novel ED module made a unique contribution to the treatment of depression and neural response to reward, and whether child-directed intervention (CDI) and parent-directed intervention (PDI) modules (standard elements of PCIT) were also effective.
METHOD


Dyads who participated in a randomized controlled trial of PCIT that compared the active PCIT-ED to a wait list (WL) condition were assessed at the completion of each module of PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression. Event-related potentials during a reward task were obtained at the end of standard PCIT and after the novel ED module.
RESULTS


Study findings showed that the ED module as well as some elements of standard PCIT were effective in reducing child depression and other forms of psychopathology. Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
CONCLUSION


Study findings suggest that the novel ED module has added efficacy for the treatment of early childhood depression, as well as unique efficacy in changing neural responses to reward and parenting response to child emotional expression. These findings can inform clinical uses of this treatment in a modular fashion. Future studies are needed that control for session number and order of PCIT-ED modules.
CLINICAL TRIAL REGISTRATION INFORMATION


A Randomized Controlled Trial of PCIT-ED for Preschool Depression; https://clinicaltrials.gov/; NCT02076425.",2020,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
","['Dyads who participated in a randomized controlled trial of', 'Preschool Depression']","['Parent Child Interaction Therapy (PCIT) with a novel Emotion Development(ED', 'PCIT', 'child directed intervention (CDI) and parent directed intervention (PDI) modules (standard elements of PCIT', 'active PCIT-ED', 'PCIT-ED']","['Event related potentials (ERPs', 'child depression', 'PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0574789,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module.
","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri. Electronic address: lubyj@wustl.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.07.937']
2891,31081504,Controlled trial of balance training using a video game console in community-dwelling older adults.,"BACKGROUND


gamification is a potentially attractive option for improving balance and reducing falls.
OBJECTIVES


to assess the effect of balance training using the NintendoTM Wii game console on balance (primary outcome), falls and fear of falling.
DESIGN


quasi-randomised, open-label, controlled clinical trial in parallel groups, carried out on community-dwelling patients over 70 years, able to walk independently. Participants were assigned 1:1 to the intervention or control group. Balance training was conducted using the Nintendo WiiFitTM twice a week for 3 months. Balance was assessed using the Tinetti balance test (primary outcome), the unipedal stance and the Wii balance tests at baseline, 3 months and 1 year. Falls were recorded and Fear of falling was assessed by the Falls Efficacy Scale (Short-FES-I).
RESULTS


1,016 subjects were recruited (508 in both the intervention and the control group; of whom 274 and 356 respectively completed the 3-month assessment). There was no between-group difference in the Tinetti balance test score, with a baseline mean of 14.7 (SD 1.8) in both groups, and 15.2 (1.3) at 3 months in the intervention group compared to 15.3 (1.7) in controls; the between-group difference was 0.06 (95% CI 0.30-0.41). No differences were seen in any of the other balance tests, or in incident falls. There was a reduction in the fear of falling at 3 months, but no effect at 1 year.
CONCLUSIONS


the study found no effect of balance training using the NintendoTM Wii on balance or falls in older community-dwelling patients.The study protocol is available at clinicaltrials.gov under the code NCT02570178.",2019,the study found no effect of balance training using the NintendoTM Wii on balance or falls in older community-dwelling patients.,"['1,016 subjects were recruited (508 in both the intervention and the control group; of whom 274 and 356 respectively completed the 3-month assessment', 'community-dwelling patients over 70 years, able to walk independently', 'community-dwelling older adults', 'older community-dwelling patients']","['balance training', 'NintendoTM Wii']","['Tinetti balance test score', 'falls and fear of falling', 'fear of falling', 'Falls Efficacy Scale', 'unipedal stance and the Wii balance tests']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0222045'}]",1016.0,0.0430319,the study found no effect of balance training using the NintendoTM Wii on balance or falls in older community-dwelling patients.,"[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Montero-Alía', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord (GRIDAES), Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Mataró, Spain.""}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Miralles-Basseda', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'López-Jiménez', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Muñoz-Ortiz', 'Affiliation': 'Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Jiménez-González', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Prat-Rovira', 'Affiliation': 'Residència de Gent Gran de Mataró. Departament de Treball, Afers Socials i Famílies, Generalitat de Catalunya, Spain.'}, {'ForeName': 'José Luís', 'Initials': 'JL', 'LastName': 'Albarrán-Sánchez', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Manresa-Domínguez', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord (GRIDAES), Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Mataró, Spain.""}, {'ForeName': 'Celia Maria', 'Initials': 'CM', 'LastName': 'Andreu-Concha', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'M Carmen', 'Initials': 'MC', 'LastName': 'Rodríguez-Pérez', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Martí-Cervantes', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Sañudo-Blanco', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Carlos Andrés', 'Initials': 'CA', 'LastName': 'Sánchez-Pérez', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Sònia', 'Initials': 'S', 'LastName': 'Dolader-Olivé', 'Affiliation': ""Centre d'Atenció Primària La Riera (Mataró 1), Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torán-Monserrat', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord (GRIDAES), Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Mataró, Spain.""}]",Age and ageing,['10.1093/ageing/afz047']
2892,32176006,"Evaluating the Effect of Infraorbital Region Taping Procedure on Patient Anxiety, Satisfaction, Edema, and Ecchymosis Level on Primary Septorhinoplasty.","AIM


This study aims to evaluate the effect of infraorbital region taping on patients' postoperative edema and ecchymosis, satisfaction levels, and anxiety during follow-up.
METHODS


A total of 64 patients who underwent septorhinoplasty were included in this randomized controlled prospective study. According to the randomization list, the taping group's (TG) infraorbital region was taped with adhesive strips. Others were included in the control group and were classified as the nontaping group. Two blinded physicians evaluated the degree of edema and ecchymosis according to the photographs of patients taken on the first, second, fifth, and seventh postoperative days. Patient's appearance satisfaction was evaluated for ecchymosis levels. State anxiety inventory (STAI-S) and trait anxiety inventory (STAI-T) were used to measure preoperative and postoperative anxiety levels of patients.
RESULTS


The degree of ecchymosis and edema were not significantly different except on the first day in the TG (P = 0.01, P = 0.01, respectively). Significant increment was found in the TG on first, second, and fifth days based on the satisfaction levels of patients for their appearance (P = 0.05, P = 0.03, P = 0.04, respectively). Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively). However, postoperative STAI-S of the TG were significantly lower compared with those of the nontaping group except seventh day (P < 0.05).
CONCLUSION


Infraorbital taping did not decrease the edema and ecchymosis except on the first postoperative day. However, it had a significant ameliorating effect on patients' anxiety and satisfaction levels.",2020,"Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively).",['64 patients who underwent septorhinoplasty'],"['Infraorbital Region Taping Procedure', 'infraorbital region taping']","['edema and ecchymosis', 'postoperative STAI-S of the TG', 'degree of edema and ecchymosis', 'Preoperative STAI-S and STAI-T', 'degree of ecchymosis and edema', 'satisfaction levels', ""patients' anxiety and satisfaction levels"", 'State anxiety inventory (STAI-S) and trait anxiety inventory (STAI-T', 'Patient Anxiety, Satisfaction, Edema, and Ecchymosis Level', ""patients' postoperative edema and ecchymosis, satisfaction levels, and anxiety""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",64.0,0.0200119,"Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively).","[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Tastan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Ankara Training Research and Referral Hospital, Ulucanlar Caddesi Altindag, Ankara, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006292']
2893,30590387,The Interaction of a Diabetes Gene Risk Score With 3 Different Antihypertensive Medications for Incident Glucose-level Elevation.,"BACKGROUND


Elevations of fasting glucose (FG) levels are frequently encountered in people treated with thiazide diuretics. The risk is lower in people treated with ACE inhibitors (ACEi). To determine if genetic factors play a role in FG elevation, we examined the interaction of a diabetes gene risk score (GRS) with the use of 3 different antihypertensive medications.
METHODS


We examined 376 nondiabetic hypertensive individuals with baseline FG <100 mg/dl who were genotyped for 24 genes associated with risk of elevated glucose levels. All participants had ≥1 follow-up FG level over 6 years of follow-up. Participants were randomized to treatment with a thiazide-like diuretic (chlorthalidone), a calcium channel blocker (CCB; amlodipine), or an ACEi (lisinopril). Outcomes were an FG increase of ≥13 or ≥27 mg/dl, the upper 75% and 90% FG increase in the parent cohort from which the present cohort was obtained. Odds ratios were adjusted for factors that increase FG levels.
RESULTS


For every 1 allele increase in GRS, the adjusted odds ratios (ORs) were 1.06 (95% confidence interval (CI): 0.99, 1.14; P = 0.06) and 1.09 (95% CI: 0.99, 1.20; P = 0.08). When results were examined by randomized medications, participants randomized to amlodipine had statistically significant odds for either outcome (OR: 1.23; 95% CI: 1.03, 1.48; P = 0.01 and OR: 1.31; 95% CI: 1.06, 1.62; P = 0.01). No such risk increase was found in participants randomized to the other 2 medications.
CONCLUSIONS


A diabetes GRS predicts FG elevation in people treated with a CCB, but not with an ACEi or diuretic. These findings require confirmation.
CLINICAL TRIALS REGISTRATION


Trial number NCT00000542.",2019,"A diabetes GRS predicts FG elevation in people treated with a CCB, but not with an ACEi or diuretic.","['All participants had ≥1 follow-up FG level over 6 years of follow-up', '376 nondiabetic hypertensive individuals with baseline FG <100 mg/dl who were genotyped for 24 genes associated with risk of elevated glucose levels', 'people treated with thiazide diuretics']","['calcium channel blocker (CCB; amlodipine), or an ACEi (lisinopril', 'thiazide-like diuretic (chlorthalidone', 'amlodipine', 'ACEi or diuretic', 'ACE inhibitors (ACEi']","['Incident Glucose-level Elevation', 'fasting glucose (FG) levels', 'Diabetes Gene Risk Score', 'GRS']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012802', 'cui_str': 'Benzothiadiazine Diuretics'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",376.0,0.119004,"A diabetes GRS predicts FG elevation in people treated with a CCB, but not with an ACEi or diuretic.","[{'ForeName': 'Joshua I', 'Initials': 'JI', 'LastName': 'Barzilay', 'Affiliation': 'Division of Endocrinology, Kaiser Permanente of Georgia and Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Dejian', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Department of Biostatistics, University of Texas School of Public Health, Houston, Texas, USA.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'Clinical Trial Center, University of Texas School of Public Health, Houston, Texas, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pressel', 'Affiliation': 'Clinical Trial Center, University of Texas School of Public Health, Houston, Texas, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Previn', 'Affiliation': 'Department of Biostatistics, University of Texas School of Public Health, Houston, Texas, USA.'}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'Arnett', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, Kentucky, USA.'}]",American journal of hypertension,['10.1093/ajh/hpy199']
2894,31905615,"Effect of Daily Ingestion of Quercetin-Rich Onion Powder for 12 Weeks on Visceral Fat: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study.","Quercetin, which is frequently found in vegetables such as onion, is widely found to have biological activities such as visceral fat reduction. Therefore, we performed this randomised double-blind placebo-controlled parallel-group study and analysed the effects of daily intake of quercetin-rich onion on visceral fat for 12 weeks. Seventy healthy Japanese subjects whose body mass index (BMI) was ≥23 and <30 were recruited and randomly assigned to either the quercetin-rich onion group or placebo group. The subjects ingested 9 g of onion powder per day for 12 weeks. We conducted medical interviews, hematological and biological tests; measured body composition and vital signs; and analysed the Food Frequency Questionnaire weeks 0, 4, 8, and 12. Abdominal fat area was measured using computed tomography scanning at weeks 0 and 12. No significant differences in visceral fat area (VFA) were observed between the two groups. However, in subjects whose high-density lipoprotein cholesterol was lower, VFA was significantly lower in the quercetin-rich onion group. In addition, alanine aminotransferase was significantly lower in the quercetin-rich onion group than in the placebo group. Thus, the results suggest that quercetin-rich onion may be beneficial for preventing obesity and improving liver function.",2019,No significant differences in visceral fat area (VFA) were observed between the two groups.,['Seventy healthy Japanese subjects whose body mass index (BMI) was ≥23 and <30'],"['Daily Ingestion of Quercetin-Rich Onion Powder', 'Placebo', 'quercetin-rich onion', 'placebo', 'quercetin-rich onion group or placebo']","['alanine aminotransferase', 'VFA', 'high-density lipoprotein cholesterol', 'Visceral Fat', 'visceral fat area (VFA', 'Abdominal fat area']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0029035', 'cui_str': 'Onions'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}]",70.0,0.100405,No significant differences in visceral fat area (VFA) were observed between the two groups.,"[{'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Nishi-Nopporo 59-2, Ebetsu, Hokkaido 069-8585, Japan.'}, {'ForeName': 'Takato', 'Initials': 'T', 'LastName': 'Muro', 'Affiliation': 'Tohoku Agricultural Research Center, National Agriculture and Food Research Organization, Akahira 4, Shimokuriyagawa, Morioka 020-0198, Japan.'}, {'ForeName': 'Masuko', 'Initials': 'M', 'LastName': 'Kobori', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization, Kannon-dai 2-1-12, Tsukuba, Ibaraki 305-8642, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishihira', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Nishi-Nopporo 59-2, Ebetsu, Hokkaido 069-8585, Japan.'}]",Nutrients,['10.3390/nu12010091']
2895,32045565,Randomized Controlled Trial of the Effects of 3D-Printed Models and 3D Ultrasonography on Maternal-Fetal Attachment.,"OBJECTIVE


To determine whether the addition of 3D-printed models improves maternal-fetal attachment in healthy pregnancies more than 3D ultrasonography alone.
DESIGN


Randomized, parallel-group, controlled trial.
SETTING


University- and clinic system-affiliated locations in Omaha, Nebraska.
PARTICIPANTS


Between May 2018 and February 2019, 857 pregnant women were screened for inclusion in the study, and 96 women (11%) were randomly assigned to an ultrasonography group (n = 48) or to an ultrasonography plus 3D-printed model group (n = 48).
METHODS


Participants completed the Maternal Antenatal Attachment Scale (MAAS) questionnaire before they received third trimester 3D ultrasonography. Participants were randomly allocated to receive 3D ultrasonography only or 3D ultrasonography plus 3D-printed models of the fetus's face. All participants completed a second MAAS questionnaire approximately 14 days after the study ultrasonography. The primary outcome was the global MAAS score. Secondary outcomes included the MAAS subscale scores.
RESULTS


The time-by-group interaction effect indicated that change in MAAS global score from baseline for the 3D-printed model group was 3.75 points greater than the score for the ultrasonography only group (95% confidence interval [1.40, 6.10], p = .002). Similar results were observed for the subscales with regard to quality of attachment and time spent thinking about the fetus.
CONCLUSIONS


The use of fetal facial models resulted in greater increases in maternal-fetal attachment than the use of ultrasonography only. Future research into this new technology to enhance pregnancy outcomes is clearly warranted.",2020,Participants were randomly allocated to receive 3D ultrasonography only or 3D ultrasonography plus 3D-printed models of the fetus's face.,"['healthy pregnancies more than 3D ultrasonography alone', '857 pregnant women were screened for inclusion in the study, and 96 women (11', 'Between May 2018 and February 2019', 'University- and clinic system-affiliated locations in Omaha, Nebraska']","['3D-printed models', 'ultrasonography plus 3D-printed model group', 'ultrasonography', '3D-Printed Models and 3D Ultrasonography', ""3D ultrasonography only or 3D ultrasonography plus 3D-printed models of the fetus's face""]","['maternal-fetal attachment', 'MAAS global score', 'Maternal-Fetal Attachment', 'Maternal Antenatal Attachment Scale (MAAS) questionnaire', 'global MAAS score', 'MAAS subscale scores', 'quality of attachment and time spent thinking about the fetus']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0027523', 'cui_str': 'Nebraska'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}]",857.0,0.181472,Participants were randomly allocated to receive 3D ultrasonography only or 3D ultrasonography plus 3D-printed models of the fetus's face.,"[{'ForeName': 'John Joseph', 'Initials': 'JJ', 'LastName': 'Coté', 'Affiliation': ''}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Badura-Brack', 'Affiliation': ''}, {'ForeName': 'Ryan William', 'Initials': 'RW', 'LastName': 'Walters', 'Affiliation': ''}, {'ForeName': 'Nicholas Gregory', 'Initials': 'NG', 'LastName': 'Dubay', 'Affiliation': ''}, {'ForeName': 'Marley Rain', 'Initials': 'MR', 'LastName': 'Bredehoeft', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2020.01.003']
2896,32147962,Nutritional training in a humanitarian context: Evidence from a cluster randomized trial.,"Behavioural change communication interventions have been shown to be effective at improving infant and young child nutrition knowledge and practices. However, evidence in humanitarian response contexts is scarce. Using data on secondary outcomes of breastfeeding, water treatment, and knowledge from a cluster randomized control trial of the Yemen Cash for Nutrition programme's impact on child nutritional status, this paper shows that the programme significantly improved knowledge and practices for poor women with young children in the pilot districts. The intervention consisted of cash transfers and monthly group nutrition education sessions led by locally recruited community health volunteers. Data are based on self-reports by participants. Estimating impacts among all 1,945 women in 190 clusters randomly assigned to treatment versus control and controlling for baseline levels and community characteristic and adjusting for noncompliance with randomization, the programme increased the probability of breastfeeding initiation within the first hour after delivery by 15.6% points (p < .05; control = 74.4% and treatment = 83.6%), the probability of exclusive breastfeeding during the first 6 months by 14.4% points (control = 13.5% and treatment = 25.3%), the probability of households treating water consumed by adults by 16.7% points (p < .01; control = 13.9% and treatment = 23.4%), and treating water consumed by children under two by 10.3% points (p < .10; control = 31.2% and treatment = 37.9%). Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women. This study was registered at 3ie (RIDIE-STUDY-ID-5b4eff881b29a) and funded by the Nordic Trust Fund and Consultative Group on International Agricultural Research programme on Policies, Institutions, and Markets.",2020,"Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women.","['1,945 women in 190 clusters', 'poor women with young children in the pilot districts']","['Nutritional training', 'Behavioural change communication interventions', 'cash transfers and monthly group nutrition education sessions led by locally recruited community health volunteers']","['knowledge and breastfeeding', 'probability of breastfeeding initiation', 'probability of households treating water consumed', 'knowledge and practices', 'probability of exclusive breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",,0.0644721,"Impacts on knowledge and breastfeeding are similar for both literate and illiterate women, and water treatment impacts are significantly larger for literate women.","[{'ForeName': 'Sikandra', 'Initials': 'S', 'LastName': 'Kurdi', 'Affiliation': 'DSG, International Food Policy Research Institute.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Figueroa', 'Affiliation': 'National Institute of Public Health of Mexico.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'DSG, International Food Policy Research Institute.'}]",Maternal & child nutrition,['10.1111/mcn.12973']
2897,31285228,"Phase Ib Trial To Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of Filociclovir (MBX-400, Cyclopropavir) in Healthy Volunteers.","Filociclovir (MBX-400, cyclopropavir) is an antiviral agent with activity against cytomegalovirus (CMV). A phase 1, double-blind, randomized, placebo-controlled (3:1 ratio), single-center, multiple-ascending-dose trial was conducted to assess the safety, tolerability, and pharmacokinetics of filociclovir. Filociclovir ( n  = 18) or placebo ( n  = 6) was administered as a daily oral dose (100 mg, 350 mg, or 750 mg) for 7 days to normal healthy adults (ages, 25 to 65 years) who were monitored for 22 days. Safety assessments included clinical, laboratory, and electrocardiogram monitoring. Plasma and urine samplings were used to determine pharmacokinetic parameters. All study product-related adverse events were mild, most commonly gastrointestinal (17%), nervous system (11%), and skin and subcutaneous tissue (11%) disorders. One subject had reversible grade 3 elevation in serum creatinine and bilirubin, which was associated with an ∼1-log increase in plasma filociclovir exposure compared to levels for other subjects in the same (750-mg) cohort. No other serious adverse events were observed. Plasma exposures (area under the concentration-time curve from 0 to 24 h [AUC 0-24 ]) on days 1 and 7 were similar, suggesting negligible dose accumulation. There was a sublinear increase in plasma exposure with dose, which plateaued at the daily dose of 350 mg. The amount of filociclovir recovered in the urine remained proportional to plasma exposure (AUC). Doses as low as 100 mg achieved plasma concentrations sufficient to inhibit CMV  in vitro  (This study has been registered at ClinicalTrials.gov under identifier NCT02454699.).",2019,No other serious adverse events were observed.,"['Healthy Volunteers', 'normal healthy adults (ages 25-65 years) who were followed for 22 days']","['Filociclovir (MBX-400, Cyclopropavir', 'Filociclovir', 'placebo', 'Filociclovir (MBX-400, cyclopropavir']","['safety, tolerability, and pharmacokinetics of filociclovir', 'skin and subcutaneous tissue', 'serum creatinine and bilirubin', 'clinical, laboratory and electrocardiogram monitoring', 'plasma filociclovir exposure', 'plasma exposure', 'serious adverse events', 'nervous system']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1531162', 'cui_str': 'cyclopropavir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0870032', 'cui_str': 'Skin and subcutaneous tissue'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027763', 'cui_str': 'Nervous System'}]",,0.250872,No other serious adverse events were observed.,"[{'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'The Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Decatur, Georgia, USA nroupha@emory.edu.'}, {'ForeName': 'Selwyn J', 'Initials': 'SJ', 'LastName': 'Hurwitz', 'Affiliation': 'Laboratory of Biochemical Pharmacology, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': 'The Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Decatur, Georgia, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'The Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Decatur, Georgia, USA.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Anderson', 'Affiliation': ""Emory Children's Center, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Deye', 'Affiliation': 'Division of Microbiology and Infectious Diseases, NIAID, NIH, Rockville, Maryland, USA.'}, {'ForeName': 'Blaire', 'Initials': 'B', 'LastName': 'Osborn', 'Affiliation': 'Division of Microbiology and Infectious Diseases, NIAID, NIH, Rockville, Maryland, USA.'}, {'ForeName': 'Shu Yi', 'Initials': 'SY', 'LastName': 'Cai', 'Affiliation': 'Division of Microbiology and Infectious Diseases, NIAID, NIH, Rockville, Maryland, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Focht', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Amegashie', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': 'Terry L', 'Initials': 'TL', 'LastName': 'Bowlin', 'Affiliation': 'Microbiotix, Inc., Worcester, Massachusetts, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Microbiotix, Inc., Worcester, Massachusetts, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'Alexandria Center for Life Sciences (West Tower), New York University Langone Medical Center, New York, New York, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00717-19']
2898,31128957,An RCT of Dating Matters: Effects on Teen Dating Violence and Relationship Behaviors.,"INTRODUCTION


Teen dating violence is a serious public health problem with few effective prevention strategies. This study examines whether the Dating Matters comprehensive prevention model, compared with a standard of care intervention, prevented negative relationship behaviors and promoted positive relationship behaviors.
STUDY DESIGN


This longitudinal, cluster-RCT compared the effectiveness of Dating Matters with standard of care across middle school. Standard of care was an evidence-based teen dating violence prevention curriculum (Safe Dates) implemented in eighth grade.
SETTING/PARTICIPANTS


Forty-six middle schools in high-risk urban neighborhoods in four U.S. cities were randomized. Schools lost to follow-up were replaced with new schools, which were independently randomized (71% school retention). Students were surveyed in fall and spring of sixth, seventh, and eighth grades (2012-2016). The analysis sample includes students from schools implementing Dating Matters or standard of care for >2 years who started sixth grade in the fall of 2012 or 2013 and had dated (N=2,349 students, mean age 12 years, 49% female, and 55% black, non-Hispanic, 28% Hispanic, 17% other).
INTERVENTION


Dating Matters is a comprehensive, multicomponent prevention model including classroom-delivered programs for sixth to eighth graders, training for parents of sixth to eighth graders, educator training, a youth communications program, and local health department activities to assess capacity and track teen dating violence-related policy and data.
MAIN OUTCOME MEASURES


Self-reported teen dating violence perpetration and victimization, use of negative conflict resolution strategies, and positive relationship skills were examined as outcomes. Imputation and analyses were conducted in 2017.
RESULTS


Latent panel models demonstrated significant program effects for three of four outcomes; Dating Matters students reported 8.43% lower teen dating violence perpetration, 9.78% lower teen dating violence victimization, and 5.52% lower use of negative conflict resolution strategies, on average across time points and cohorts, than standard of care students. There were no significant effects on positive relationship behaviors.
CONCLUSIONS


Dating Matters demonstrates comparative effectiveness, through middle school, for reducing unhealthy relationship behaviors, such as teen dating violence and use of negative conflict resolution strategies, relative to the standard of care intervention.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01672541.",2019,"Dating Matters is a comprehensive, multicomponent prevention model including classroom-delivered programs for sixth to eighth graders, training for parents of sixth to eighth graders, educator training, a youth communications program, and local health department activities to assess capacity and track teen dating violence-related policy and data.
","['Forty-six middle schools in high-risk urban neighborhoods in four U.S. cities', 'students from schools implementing Dating Matters or standard of care for >2 years who started sixth grade in the fall of 2012 or 2013 and had dated (N=2,349 students, mean age 12 years, 49% female, and 55% black, non-Hispanic, 28% Hispanic, 17% other', 'Students were surveyed in fall and spring of sixth, seventh, and eighth grades (2012-2016']",[],"['Self-reported teen dating violence perpetration and victimization, use of negative conflict resolution strategies, and positive relationship skills', 'positive relationship behaviors']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0520668,"Dating Matters is a comprehensive, multicomponent prevention model including classroom-delivered programs for sixth to eighth graders, training for parents of sixth to eighth graders, educator training, a youth communications program, and local health department activities to assess capacity and track teen dating violence-related policy and data.
","[{'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. Electronic address: pniolon@cdc.gov.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Tracy', 'Affiliation': '2M Research Services, Atlanta, Georgia.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Latzman', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Texas Tech University, Institute for Measurement, Methodology, Analysis and Policy, Lubbock, Texas.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Lang', 'Affiliation': 'Texas Tech University, Institute for Measurement, Methodology, Analysis and Policy, Lubbock, Texas.'}, {'ForeName': 'Lianne Fuino', 'Initials': 'LF', 'LastName': 'Estefan', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Sharon R', 'Initials': 'SR', 'LastName': 'Ghazarian', 'Affiliation': '2M Research Services, Atlanta, Georgia.'}, {'ForeName': 'Wendy Li KamWa', 'Initials': 'WLK', 'LastName': 'McIntosh', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'NORC, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Johnson', 'Affiliation': 'SciMetrika, McLean, Virginia.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Kuoh', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Fortson', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mumford', 'Affiliation': 'NORC, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Shannon C', 'Initials': 'SC', 'LastName': 'Nelson', 'Affiliation': 'NORC, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Joseph', 'Affiliation': 'NORC, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Linda Anne', 'Initials': 'LA', 'LastName': 'Valle', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Andra Teten', 'Initials': 'AT', 'LastName': 'Tharp', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.02.022']
2899,31566694,Does Compression of the Fourth Ventricle Cause Preterm Labor? Analysis of Data From the PROMOTE Study.,"Background


The technique for the compression of the fourth ventricle (CV4) in the brain has been described as a method of reaching the physiologic centers that reside in its floor and of restoring optimal flow of the cerebrospinal fluid. However, a study published as an abstract in 1992 questioned whether CV4, when applied to pregnant women, could induce uterine contractions and possibly labor.
Objective


To further examine whether CV4 could induce uterine contractions and labor as part of the osteopathic manipulative treatment (OMT) protocol used in the Pregnancy Research in Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study.
Methods


Labor and delivery data collected during the PROMOTE study from 2007-2011 were analyzed. The PROMOTE study was funded by the National Institutes of Health and was a randomized controlled clinical trial that measured the primary outcomes of back-specific functioning and pain in pregnant women aged 18 to 34 years. Participants were randomly divided into 3 groups-usual obstetric care only, placebo ultrasound treatment plus usual obstetric care, and OMT plus usual obstetric care. Study participants were scheduled for 7 treatment visits. Presented data were gathered from labor and delivery records.
Results


Four hundred participants were included. No significant differences were identified between treatment groups for the development of high-risk status (P=.293) or preterm delivery (P=.673). Evaluation of high-risk status by preterm delivery for the groups also showed no significant differences between groups (P=.455).
Conclusion


The application of CV4 as part of an OMT protocol during the third trimester caused neither a higher incidence of preterm labor nor the development of high-risk status.",2019,No significant differences were identified between treatment groups for the development of high-risk status (P=.293) or preterm delivery (P=.673).,"['pregnant women aged 18 to 34 years', 'Four hundred participants were included', 'Study participants were scheduled for 7 treatment visits']","['CV4', 'usual obstetric care only, placebo ultrasound treatment plus usual obstetric care, and OMT plus usual obstetric care']","['development of high-risk status', 'back-specific functioning and pain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0450813', 'cui_str': 'CV4 (body structure)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",400.0,0.0639718,No significant differences were identified between treatment groups for the development of high-risk status (P=.293) or preterm delivery (P=.673).,"[{'ForeName': 'Kendi L', 'Initials': 'KL', 'LastName': 'Hensel', 'Affiliation': ''}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Roane', 'Affiliation': ''}]",The Journal of the American Osteopathic Association,['10.7556/jaoa.2019.114']
2900,32058231,"Comments on ""A pilot cluster-randomised study to increase sleep duration by decreasing electronic media use at night and caffeine consumption in adolescents"".",,2020,,['adolescents'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.0168707,,"[{'ForeName': 'S M J', 'Initials': 'SMJ', 'LastName': 'Mortazavi', 'Affiliation': 'Medical Physics Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Diagnostic Imaging Department, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA. Electronic address: mortazavismj@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Medical Physics Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'S A R', 'Initials': 'SAR', 'LastName': 'Mortazavi', 'Affiliation': 'School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Sleep medicine,['10.1016/j.sleep.2019.12.028']
2901,31453902,"Pain and Bruising Levels After Lip Augmentation: A Comparison of Anterograde and Retrograde Techniques Using an Automated Motorized Injection Device. A Blinded, Prospective, Randomized, Parallel Within-Subject Trial.","BACKGROUND


Dermal fillers for lip augmentation can be injected using various techniques. Although all seem to provide acceptable results, it is not clear which technique is safer, less painful, and provides greater patient comfort.
OBJECTIVE


To compare patients' self-reported pain intensity during the injection of hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde.
METHODS AND MATERIALS


Prospective, single-center, within-subject, single-blinded, randomized controlled trial. All subjects received injections in the lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique. An automated motorized injection device was used to ensure a homogeneous deposition flow of the product injected and reduce operator bias. Pain intensity was self-assessed using a 100-mm visual analog scale. Presence and severity of bruising were recorded.
RESULTS


Forty-four women (mean age 30.3 years) were randomized. Mean self-reported pain score was 53.1% lower with the anterograde technique than with the retrograde (p < .0001). The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique.
CONCLUSION


This study demonstrated that the anterograde technique was less painful, and led to fewer bruising and site reactions than the retrograde technique when using an automated device.
LEVEL OF EVIDENCE


I.",2020,"The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique.
",['Forty-four women (mean age 30.3 years'],"['Anterograde and Retrograde Techniques Using an Automated Motorized Injection Device', 'hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde', 'lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique']","['pain intensity', 'rates of site reactions', 'Presence and severity of bruising', 'bruising and site reactions', 'Mean self-reported pain score', 'Pain intensity', 'Pain and Bruising Levels']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0794888', 'cui_str': 'Injection device (physical object)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C4042850', 'cui_str': 'Skin Fillers'}, {'cui': 'C4523976', 'cui_str': 'Lip augmentation'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",44.0,0.207937,"The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique.
","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Galadari', 'Affiliation': 'College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mariwalla', 'Affiliation': 'Mariwalla Dermatology, West Islip, New York.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Delobel', 'Affiliation': 'Teoxane Laboratories, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sanchez-Vizcaino Mengual', 'Affiliation': 'i2e3 Biomedical Research Institute, Barcelona, Spain.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002055']
2902,31106381,"Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS).","STUDY OBJECTIVES


We compared resident physician work hours and sleep in a multicenter clustered-randomized crossover clinical trial that randomized resident physicians to an Extended Duration Work Roster (EDWR) with extended-duration (≥24 hr) shifts or a Rapidly Cycling Work Roster (RCWR), in which scheduled shift lengths were limited to 16 or fewer consecutive hours.
METHODS


Three hundred two resident physicians were enrolled and completed 370 1 month pediatric intensive care unit rotations in six US academic medical centers. Sleep was objectively estimated with wrist-worn actigraphs. Work hours and subjective sleep data were collected via daily electronic diary.
RESULTS


Resident physicians worked fewer total hours per week during the RCWR compared with the EDWR (61.9 ± 4.8 versus 68.4 ± 7.4, respectively; p < 0.0001). During the RCWR, 73% of work hours occurred within shifts of ≤16 consecutive hours. In contrast, during the EDWR, 38% of work hours occurred on shifts of ≤16 consecutive hours. Resident physicians obtained significantly more sleep per week on the RCWR (52.9 ± 6.0 hr) compared with the EDWR (49.1 ± 5.8 hr, p < 0.0001). The percentage of 24 hr intervals with less than 4 hr of actigraphically measured sleep was 9% on the RCWR and 25% on the EDWR (p < 0.0001).
CONCLUSIONS


RCWRs were effective in reducing weekly work hours and the occurrence of >16 consecutive hour shifts, and improving sleep duration of resident physicians. Although inclusion of the six operational healthcare sites increases the generalizability of these findings, there was heterogeneity in schedule implementation. Additional research is needed to optimize scheduling practices allowing for sufficient sleep prior to all work shifts.Clinical Trial: Multicenter Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety (ROSTERS), https://clinicaltrials.gov/ct2/show/NCT02134847.",2019,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).",['302 resident physicians were enrolled and completed 370 one-month pediatric intensive care unit rotations in six U.S. academic medical centers'],['Extended Duration Work Roster (EDWR) with extended-duration (≥24 hours) shifts or a Rapidly Cycling Work Roster (RCWR'],"['Work hours and subjective sleep data', 'Sleep', 'percentage of 24-hour intervals']","[{'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0379673,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Blackwell', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""University of Iowa Stead Family Children's Hospital, Iowa City, IA.""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, VA.""}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sleep,['10.1093/sleep/zsz110']
2903,31062842,"Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care-a cluster randomised, controlled trial.","OBJECTIVES


this prospective, cluster randomised, controlled trial investigated the effect of oral neuromuscular training among older people in intermediate care with impaired swallowing.
METHODS


older people (≥65 years) with swallowing dysfunction were cluster randomised according to care units for 5 weeks of neuromuscular training of the orofacial and pharyngeal muscles or usual care. The primary endpoint was the change in swallowing rate (assessed with a timed water swallow test) from baseline to the end-of-treatment and 6 months post-treatment. The secondary endpoints were changes in signs of aspiration during the water swallow test, and swallowing-related quality of life (QOL). An intention-to-treat principle was followed, and mixed-effects models were used for data analysis with the clustered study design as a random factor.
RESULTS


in total, 385 participants from 36 intermediate care units were screened, and 116 participants were randomly assigned to oral neuromuscular training (intervention; n = 49) or usual care (controls; n = 67). At the end of treatment, the geometric mean of the swallowing rate in the intervention group had significantly improved 60% more than that of controls (P = 0.007). At 6 months post-treatment, the swallowing rate of the intervention group remained significantly better (P = 0.031). Signs of aspiration also significantly reduced in the intervention group compared with controls (P = 0.01). No significant between-group differences were found for swallowing-related QOL.
CONCLUSIONS


oral neuromuscular training is a new promising swallowing rehabilitation method among older people in intermediate care with impaired swallowing.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02825927.",2019,"At 6 months post-treatment, the swallowing rate of the intervention group remained significantly better (P = 0.031).","['in total, 385 participants from 36 intermediate care units were screened, and 116 participants', 'older people in intermediate care with impaired swallowing', 'older people in intermediate care', 'older people (≥65 years) with swallowing dysfunction']","['oral neuromuscular training', 'oral neuromuscular training (intervention; n = 49) or usual care', 'neuromuscular training of the orofacial and pharyngeal muscles or usual care']","['change in swallowing rate', 'swallowing rate', 'Signs of aspiration', 'changes in signs of aspiration during the water swallow test, and swallowing-related quality of life (QOL', 'swallowing-related QOL', 'geometric mean of the swallowing rate', 'swallowing dysfunction']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517751', 'cui_str': 'Three hundred and eighty-five'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0031346', 'cui_str': 'Muscles of Pharynx'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",385.0,0.0988043,"At 6 months post-treatment, the swallowing rate of the intervention group remained significantly better (P = 0.031).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hägglund', 'Affiliation': 'Oral and Maxillofacial Radiology, Department of Odontology, Faculty of Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hägg', 'Affiliation': 'Department of Otorhinolaryngology, Speech and Swallowing Centre, Hudiksvall Hospital, Region Gävleborg, Hudiksvall, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Wester', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Levring Jäghagen', 'Affiliation': 'Oral and Maxillofacial Radiology, Department of Odontology, Faculty of Medicine, Umeå University, Umeå, Sweden.'}]",Age and ageing,['10.1093/ageing/afz042']
2904,32068484,"International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.","PURPOSE


We assessed efficacy, safety and tolerability of vibegron, a novel, potent, highly selective β 3 -adrenoceptor agonist, administered 12 weeks at 75 mg once daily to patients with overactive bladder in an international phase III trial with placebo and active control.
MATERIALS AND METHODS


Adult patients with overactive bladder with 8.0 or more micturitions per day were randomized 5:5:4 to 75 mg vibegron, placebo or extended-release 4 mg extended-release tolterodine. Up to 25% of patients could have dry overactive bladder (less than 1.0 urge incontinence episode per day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8 and 12.
RESULTS


Of 1,518 randomized patients 90.4% completed the trial. At 12 weeks micturitions decreased by an adjusted mean of 1.8 episodes per day for vibegron vs 1.3 for placebo (p <0.001, co-primary end point) and 1.6 for tolterodine. Among incontinent patients urge incontinence episodes decreased by an adjusted mean 2.0 episodes per day for vibegron vs 1.4 for placebo (p <0.0001, co-primary end point) and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes (all p <0.01). Among vibegron treated patients 1.7% discontinued treatment because of adverse events vs 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron and for placebo.
CONCLUSIONS


Once daily 75 mg vibegron provided statistically significant reductions in micturitions, urgency episodes and urge incontinence, and increased the volume per micturition. Treatment was well tolerated with a favorable safety profile.",2020,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","['Adult patients with overactive bladder with ≥8.0 micturitions/day', 'Patients with Symptoms of Overactive Bladder', 'patients with overactive bladder in an international phase III trial with']","['vibegron 75 mg, placebo, or extended-release tolterodine 4 mg', 'Vibegron', 'placebo', 'placebo and active control', 'tolterodine', 'Placebo']","['efficacy, safety, and tolerability', 'number of urgency episodes, volume per micturition', 'Safety and Efficacy', '7-day voiding diaries', 'micturitions, urgency episodes, urge incontinence, and increased the volume per micturition', 'adverse events', 'urge-incontinence episodes', 'Incidence of hypertension', 'dry overactive bladder']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",1518.0,0.512834,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, Washington.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, Connecticut.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California.'}]",The Journal of urology,['10.1097/JU.0000000000000807']
2905,31648815,A double-blind randomized controlled trial of the effects of eicosapentaenoic acid supplementation on muscle inflammation and physical function in patients undergoing colorectal cancer resection.,"BACKGROUND


Resection of colorectal cancer (CRC) initiates inflammation, mediated at least partly by NFĸB (nuclear factor kappa-light-chain-enhancer of activated B-cells), leading to muscle catabolism and reduced physical performance. Eicosapentaenoic acid (EPA) has been shown to modulate NFĸB, but evidence for its benefit around the time of surgery is limited.
OBJECTIVE


To assess the effect of EPA supplementation on muscle inflammation and physical function around the time of major surgery.
DESIGN


In a double-blind randomized control trial, 61 patients (age: 68.3 ± 0.95 y; 42 male) scheduled for CRC resection, received 3 g per day of EPA (n = 32) or placebo (n = 29) for 5-days before and 21-days after operation. Lean muscle mass (LMM) (via dual energy X-ray absorptiometry (DXA)), anaerobic threshold (AT) (via cardiopulmonary exercise testing (CPET)) and hand-grip strength (HG) were assessed before and 4-weeks after surgery, with muscle biopsies (m. vastus lateralis) obtained for the assessment of NF-ĸB protein expression.
RESULTS


There were no differences in muscle NFĸB between EPA and placebo groups (mean difference (MD) -0.002; 95% confidence interval (CI) -0.19 to 0.19); p = 0.98). There was no difference in LMM (MD 704.77 g; 95% CI -1045.6 g-2455.13 g; p = 0.42) or AT (MD 1.11 mls/kg/min; 95% CI -0.52 mls/kg/min to 2.74 mls/kg/min; p = 0.18) between the groups. Similarly, there was no difference between the groups in HG at follow up (MD 0.1; 95% CI -1.88 to 2.08; p = 0.81). Results were similar when missing data was imputed.
CONCLUSION


EPA supplementation confers no benefit in terms of inflammatory status, as judged by NFĸB, or preservation of LMM, aerobic capacity or physical function following major colorectal surgery.
CLINICAL TRIALS REFERENCE


NCT01320319.",2020,There were no differences in muscle NFĸB between EPA and placebo groups (mean difference (MD) -0.002; 95% confidence interval (CI) -0.19 to 0.19); p = 0.98).,"['61 patients (age: 68.3\xa0±\xa00.95\xa0y; 42 male) scheduled for', 'patients undergoing colorectal cancer resection']","['Eicosapentaenoic acid (EPA', 'eicosapentaenoic acid supplementation', 'CRC resection, received 3\xa0g per day of EPA', 'placebo', 'EPA supplementation']","['muscle inflammation and physical function', 'muscle NFĸB', 'Lean muscle mass (LMM) (via dual energy X-ray absorptiometry (DXA)), anaerobic threshold (AT) (via cardiopulmonary exercise testing (CPET)) and hand-grip strength (HG', 'LMM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0027121', 'cui_str': 'Inflammatory Myopathy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",61.0,0.657665,There were no differences in muscle NFĸB between EPA and placebo groups (mean difference (MD) -0.002; 95% confidence interval (CI) -0.19 to 0.19); p = 0.98).,"[{'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Hossain', 'Affiliation': 'Departments of Surgery and Anaesthetics, Royal Derby Hospital, Derby, DE22 3DT, UK.'}, {'ForeName': 'Bethan E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'Clinical, Metabolic and Molecular Physiology Research Group, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK; Medical Research Council, Arthritis Research UK Centre for Musculoskeletal Ageing Research, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doleman', 'Affiliation': 'Departments of Surgery and Anaesthetics, Royal Derby Hospital, Derby, DE22 3DT, UK.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Lund', 'Affiliation': 'Departments of Surgery and Anaesthetics, Royal Derby Hospital, Derby, DE22 3DT, UK; Clinical, Metabolic and Molecular Physiology Research Group, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK; Medical Research Council, Arthritis Research UK Centre for Musculoskeletal Ageing Research, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Williams', 'Affiliation': 'Departments of Surgery and Anaesthetics, Royal Derby Hospital, Derby, DE22 3DT, UK; Clinical, Metabolic and Molecular Physiology Research Group, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK; Medical Research Council, Arthritis Research UK Centre for Musculoskeletal Ageing Research, University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, UK. Electronic address: john.williams7@nhs.net.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.09.009']
2906,31668721,"A randomized, controlled, double-blind crossover study on the effects of isoeffective and isovolumetric intravenous crystalloid and gelatin on blood volume, and renal and cardiac hemodynamics.","BACKGROUND & AIMS


Blood volume expanding properties of colloids are superior to crystalloids. In addition to oncotic/osmotic properties, the electrolyte composition of infusions may have important effects on visceral perfusion, with infusions containing supraphysiological chloride causing hyperchloremic acidosis and decreased renal blood flow. In this non-inferiority study, a validated healthy human subject model was used to compare effects of colloid (4% succinylated gelatin) and crystalloid fluid regimens on blood volume, renal function, and cardiac output.
METHODS


Healthy male participants were given infusions over 60 min > 7 days apart in a randomized, crossover manner. Reference arm (A): 1.5 L of Sterofundin ISO, isoeffective arm (B): 0.5 L of 4% Gelaspan®, isovolumetric arm (C): 0.5 L of 4% Gelaspan® and 1 L of Sterofundin ISO (all B. Braun, Melsungen, Germany). Participants were studied over 240 min. Changes in blood volume were calculated from changes in weight and hematocrit. Renal volume, renal artery blood flow (RABF), renal cortex perfusion and diffusion, and cardiac index were measured with magnetic resonance imaging.
RESULTS


Ten of 12 males [mean (SE) age 23.9 (0.8) years] recruited, completed the study. Increase in body weight and extracellular fluid volume were significantly less after infusion B than infusions A and C, but changes in blood volume did not significantly differ between infusions. All infusions increased renal volume, with no significant differences between infusions. There was no significant difference in RABF across the infusion time course or between infusion types. Renal cortex perfusion decreased during the infusion (mean 18% decrease from baseline), with no significant difference between infusions. There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion. All infusions led to significant increases in cardiac index.
CONCLUSIONS


A smaller volume of colloid (4% succinylated gelatin) was as effective as a larger volume of crystalloid at expanding blood volume, increasing cardiac output and changing renal function. Significantly less interstitial space expansion occurred with the colloid.
TRIAL REGISTRATION


The protocol was registered with the European Union Drug Regulating Authorities Clinical Trials Database (https://eudract.ema.europa.eu) (EudraCT No. 2013-003260-32).",2020,There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion.,"['Ten of 12 males [mean (SE) age 23.9 (0.8) years] recruited, completed the study', 'Healthy male participants']","['infusions over 60\xa0min', 'isoeffective and isovolumetric intravenous crystalloid and gelatin', 'Sterofundin ISO, isoeffective arm (B): 0.5\xa0L of 4% Gelaspan®, isovolumetric arm (C): 0.5\xa0L of 4% Gelaspan® and 1\xa0L of Sterofundin ISO', 'colloid (4% succinylated gelatin) and crystalloid fluid regimens']","['renal volume', 'renal cortex diffusion', 'RABF', 'blood volume, renal function, and cardiac output', 'Renal volume, renal artery blood flow (RABF), renal cortex perfusion and diffusion, and cardiac index', 'cardiac index', 'Renal cortex perfusion', 'renal blood flow', 'body weight and extracellular fluid volume', 'interstitial space expansion', 'blood volume', 'blood volume, and renal and cardiac hemodynamics', 'cardiac output and changing renal function']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0630627', 'cui_str': 'sterofundin'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0143961', 'cui_str': 'succinylated gelatin'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0022655', 'cui_str': 'Kidney Cortex'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1527409', 'cui_str': 'Renal blood flow, function (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015349', 'cui_str': 'Extracellular Fluid'}, {'cui': 'C0225319', 'cui_str': 'Interstitial space (body structure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0853947,There was a trend for increased renal cortex diffusion (4.2% increase from baseline) for the crystalloid infusion.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bradley', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Damian D', 'Initials': 'DD', 'LastName': 'Bragg', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Eleanor F', 'Initials': 'EF', 'LastName': 'Cox', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'El-Sharkawy', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Buchanan', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Abeed H', 'Initials': 'AH', 'LastName': 'Chowdhury', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Francis', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Sir Peter Mansfield Imaging Centre, University Park, University of Nottingham, NG7 2RD, UK.""}, {'ForeName': 'Dileep N', 'Initials': 'DN', 'LastName': 'Lobo', 'Affiliation': ""Gastrointestinal Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK; MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK. Electronic address: dileep.lobo@nottingham.ac.uk.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.09.011']
2907,31175583,The Impact of Diet on Breast Cancer Outcomes.,"PURPOSE OF REVIEW


Breast cancer is the most common cancer in women, yet conclusive evidence of the effects of dietary modification in breast cancer survivors is lacking. Here, we summarize the literature and highlight important data regarding the association between dietary interventions and breast cancer outcomes.
RECENT FINDINGS


Long-term follow-up and secondary analysis of the Women's Health Initiative study demonstrated a significant improvement in overall survival for women who were randomized to the low-fat diet pattern compared with those in the usual-diet group. Dietary quality as measured by Healthy Eating Index score was also associated with both a decrease in cancer-specific mortality and overall mortality. Despite current evidence on the role of diet and nutrition in breast cancer outcomes, conclusive data to translate current findings to clinical practice is lacking and requires multidisciplinary prospective research to advance the field.",2019,Dietary quality as measured by Healthy Eating Index score was also associated with both a decrease in cancer-specific mortality and overall mortality.,[],[],"['Healthy Eating Index score', 'cancer-specific mortality and overall mortality', 'Dietary quality', 'overall survival']",[],[],"[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0298709,Dietary quality as measured by Healthy Eating Index score was also associated with both a decrease in cancer-specific mortality and overall mortality.,"[{'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA. llpeterson@wustl.edu.'}]",Current nutrition reports,['10.1007/s13668-019-00278-0']
2908,32029547,Noninvasive vagus nerve stimulation and the trigeminal autonomic reflex: An fMRI study.,"OBJECTIVE


The trigeminal autonomic reflex is a physiologic reflex that plays a crucial role in primary headache and particularly in trigeminal autonomic cephalalgias, such as cluster headache. Previous studies have shown that this reflex can be modulated by the vagus nerve, leading to an inhibition of the parasympathetic output of the reflex in healthy participants. The aim of the present study was to characterize neural correlates of the modulatory effect of noninvasive vagus nerve stimulation (nVNS) on the trigeminal autonomic reflex.
METHODS


Twenty-one healthy participants were included in a 2-day, randomized, single-blind, within-subject design. The reflex was activated inside the MRI scanner using kinetic oscillation stimulation placed in the left nostril, resulting in an increase in lacrimation. After the first fMRI session, the participants received either sham vagus nerve stimulation or nVNS outside the scanner and underwent a subsequent fMRI session.
RESULTS


nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus. Psychophysiologic interaction analyses revealed an increased functional connectivity between the left pontine nucleus and the right hypothalamus and a decreased functional connectivity between the right parahippocampal gyrus and the bilateral spinal trigeminal nuclei (sTN).
CONCLUSIONS


These findings indicate a complex network involved in the modulatory effect of nVNS including the hypothalamus, the sTN, the pontine nucleus, and the parahippocampal gyrus.",2020,"RESULTS


nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus.","['Twenty-one healthy participants', 'healthy participants']","['sham vagus nerve stimulation or nVNS outside the scanner and underwent a subsequent fMRI session', 'noninvasive vagus nerve stimulation (nVNS', 'Noninvasive vagus nerve stimulation']","['activation of the left pontine nucleus', 'functional connectivity']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0228448', 'cui_str': 'Structure of nucleus of pons'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",21.0,0.0292132,"RESULTS


nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus.","[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehnert', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Celina F', 'Initials': 'CF', 'LastName': 'Schroeder', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany. a.may@uke.de.'}]",Neurology,['10.1212/WNL.0000000000008865']
2909,30782014,"Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.","BACKGROUND/AIMS


Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes.
METHODS


A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain.
RESULTS


This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death.
CONCLUSION


The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.",2019,There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference.,"['enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization', '214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers', ""patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death.\nCONCLUSION"", 'patients with advanced cancer and pain', 'patients with advanced cancer and their family caregivers', 'patients with advanced cancer and their caregivers', 'patients with advanced cancer']","['Caregiver-guided pain coping skills training', 'caregiver-guided pain coping skills training protocol', 'caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual']","['caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress', 'pain severity and pain interference', 'caregiver self-efficacy for helping the patient manage pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",214.0,0.165889,There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': '1 Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Samsa', 'Affiliation': '1 Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Steel', 'Affiliation': '2 University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': '3 Division of Geriatric Medicine & Palliative Care Program, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'LeBlanc', 'Affiliation': '1 Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bull', 'Affiliation': '4 Four Seasons Compassion for Life, Hendersonville, NC, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': '5 University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': '1 Duke University School of Medicine, Durham, NC, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519829695']
2910,31917129,Short-Term Effects of an Obesity Prevention Program Among Low-Income Hispanic Families With Preschoolers.,"OBJECTIVE


To assess the short-term effects of an obesity prevention program promoting eating self-regulation and healthy food preferences in low-income Hispanic children.
DESIGN


Randomized controlled trial with pretest, posttest, and 6- and 12-month assessments.
SETTING AND PARTICIPANTS


Head Start and similar early learning institutions in Houston, TX, and Pasco, WA. A total of 255 families with preschoolers randomized into prevention (n = 136) and control (n = 119) groups.
INTERVENTION


Multicomponent family-based prevention program. Fourteen waves lasted 7 weeks each with 8-10 mother-child dyads in each group.
MAIN OUTCOME MEASURES


Parent assessments included feeding practices, styles, and knowledge. Child assessments included child eating self-regulation, willingness to try new foods, and parent report of child fruit and vegetable preferences. Parent and child heights and weights were measured.
ANALYSIS


Multilevel analyses were employed to consider the nested nature of the data: time points within families within waves.
RESULTS


The program had predicted effects on parental feeding practices, styles, and knowledge in the pre- to post-comparisons. Effects on child eating behavior were minimal; only the number of different vegetables tried showed significant pre-post differences.
CONCLUSIONS AND IMPLICATIONS


Short-term effects of this prevention program highlight the importance of family-focused feeding approaches to combating child overweight and obesity.",2020,"Effects on child eating behavior were minimal; only the number of different vegetables tried showed significant pre-post differences.
","['Low-Income Hispanic Families With Preschoolers', '255 families with preschoolers randomized into prevention (n\u202f=\u202f136) and control (n\u202f=\u202f119) groups', 'low-income Hispanic children']","['obesity prevention program', 'Obesity Prevention Program', 'INTERVENTION\n\n\nMulticomponent family-based prevention program']","['feeding practices, styles, and knowledge', 'parental feeding practices, styles, and knowledge', 'child eating behavior', 'child eating self-regulation, willingness to try new foods, and parent report of child fruit and vegetable preferences']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0567465', 'cui_str': 'Feeding practice (regime/therapy)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",255.0,0.041711,"Effects on child eating behavior were minimal; only the number of different vegetables tried showed significant pre-post differences.
","[{'ForeName': 'Sheryl O', 'Initials': 'SO', 'LastName': 'Hughes', 'Affiliation': ""US Department of Agriculture/Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX. Electronic address: shughes@bcm.edu.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Power', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Betz', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'L Suzanne', 'Initials': 'LS', 'LastName': 'Goodell', 'Affiliation': 'Department of Food, Bioprocessing, and Nutritional Sciences, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Hopwood', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'J Andrea', 'Initials': 'JA', 'LastName': 'Jaramillo', 'Affiliation': ""US Department of Agriculture/Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lanigan', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'AnaMaria Diaz', 'Initials': 'AD', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Micheli', 'Affiliation': ""US Department of Agriculture/Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Yadira', 'Initials': 'Y', 'LastName': 'Olivera', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Overath', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Ramos', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Yuri Peralta', 'Initials': 'YP', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, TX.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, CO.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.12.001']
2911,30723140,"A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB).","PURPOSE


Addition of alpelisib to fulvestrant significantly extended progression-free survival in  PIK3CA -mutant, hormone receptor-positive (HR + ) advanced/metastatic breast cancer in the phase III SOLAR-1 study. The combination of alpelisib and letrozole also had promising activity in phase I studies of HR +  advanced/metastatic breast cancer. NEO-ORB aimed to determine whether addition of alpelisib to letrozole could increase response rates in the neoadjuvant setting. Patients and Methods:  Postmenopausal women with HR + , human epidermal growth factor receptor 2-negative, T1c-T3 breast cancer were assigned to the  PIK3CA -wild-type or  PIK3CA -mutant cohort according to their tumor  PIK3CA  status, and randomized (1:1) to 2.5 mg/day letrozole with 300 mg/day alpelisib or placebo for 24 weeks. Primary endpoints were objective response rate (ORR) and pathologic complete response (pCR) rate for both  PIK3CA  cohorts.
RESULTS


In total, 257 patients were assigned to letrozole plus alpelisib (131 patients) or placebo (126 patients). Grade ≥3 adverse events (≥5% of patients) in the alpelisib arm were hyperglycemia (27%), rash (12%), and maculo-papular rash (8%). The primary objective was not met; ORR in the alpelisib versus placebo arm was 43% versus 45% and 63% versus 61% in the  PIK3CA -mutant and wild-type cohorts, respectively. pCR rates were low in all groups. Decreases in Ki-67 were similar across treatment arms and cohorts. In  PIK3CA -mutant tumors, alpelisib plus letrozole treatment induced a greater decrease in phosphorylated AKT versus placebo plus letrozole.
CONCLUSIONS


In contrast to initial results in advanced/metastatic disease, addition of alpelisib to 24-week neoadjuvant letrozole treatment did not improve response in patients with HR +  early breast cancer.",2019,Decreases in Ki-67 were similar across treatment arms and cohorts.,"['patients with HR +  early breast cancer', '257 patients were assigned to', 'Postmenopausal women with HR']","['pCR', 'letrozole plus alpelisib', 'letrozole with 300 mg/day alpelisib or placebo', 'placebo', 'alpelisib to fulvestrant', 'alpelisib and letrozole', 'Neoadjuvant Letrozole Plus Alpelisib', 'letrozole']","['Grade ≥3 adverse events', 'objective response rate (ORR) and pathologic complete response (pCR) rate', 'hyperglycemia', 'maculo-papular rash', 'response rates', 'Ki-67', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4055478', 'cui_str': 'Alpelisib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash (morphologic abnormality)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",257.0,0.0907798,Decreases in Ki-67 were similar across treatment arms and cohorts.,"[{'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, Tennessee. carlos.arteaga@utsouthwestern.edu ingrid.mayer@vumc.org.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': ""Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Blau', 'Affiliation': 'Rainier Hematology-Oncology, Northwest Medical Specialties, Tacoma, Washington.'}, {'ForeName': 'J Alejandro Pérez', 'Initials': 'JAP', 'LastName': 'Fidalgo', 'Affiliation': 'Department of Oncology, CIBERONC, Hospital Clínico Universitario de Valencia - INCLIVA, Valencia, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander-Universität, Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology (IEO), IRCCS, Milan, and International Breast Cancer Study Group, Milan, Italy.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Oncology, The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Obstetrics and Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Laura García', 'Initials': 'LG', 'LastName': 'Estévez', 'Affiliation': 'Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Gynecologic Oncology and Senology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mundhenke', 'Affiliation': 'Department of Obstetrics and Gynecology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Holmes', 'Affiliation': 'Texas Oncology-Houston Memorial City and US Oncology Research Network, Houston, Texas.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Babbar', 'Affiliation': 'Oncology Precision Medicine, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Charbonnier', 'Affiliation': 'Statistics, Novartis Pharma S.A.S., Rueil-Malmaison, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Diaz-Padilla', 'Affiliation': 'Oncology Global Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Florian D', 'Initials': 'FD', 'LastName': 'Vogl', 'Affiliation': 'Oncology Global Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Sellami', 'Affiliation': 'Oncology Precision Medicine, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'Department of Medicine, UTSW Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas. carlos.arteaga@utsouthwestern.edu ingrid.mayer@vumc.org.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3160']
2912,30289426,The Association of Changes in Pain Acceptance and Headache-Related Disability.,"BACKGROUND


Migraine accounts for substantial suffering and disability. Previous studies show cross-sectional associations between higher pain acceptance and lower headache-related disability in individuals with migraine, but none has evaluated this association longitudinally during migraine treatment.
PURPOSE


This study evaluated whether changes in pain acceptance were associated with changes in headache-related disability and migraine characteristics in a randomized controlled trial (Women's Health and Migraine) that compared effects of behavioral weight loss (BWL) treatment and migraine education (ME) on headache frequency in women with migraine and overweight/obesity.
METHODS


This was a post hoc analysis of 110 adult women with comorbid migraine and overweight/obesity who received 16 weeks of either BWL or ME. Linear and nonlinear mixed effects modeling methods were used to test for between-group differences in change in pain acceptance, and also to examine the association between change in pain acceptance and change in headache disability.
RESULTS


BWL and ME did not differ on improvement in pain acceptance from baseline across post-treatment and follow-up. Improvement in pain acceptance was associated with reduced headache disability, even when controlling for intervention-related improvements in migraine frequency, headache duration, and pain intensity.
CONCLUSIONS


This study is the first to show that improvements in pain acceptance following two different treatments are associated with greater reductions in headache-related disability, suggesting a potential new target for intervention development.
CLINICAL TRIALS INFORMATION


NCT01197196.",2019,"RESULTS


BWL and ME did not differ on improvement in pain acceptance from baseline across post-treatment and follow-up.","['women with migraine and overweight/obesity', '110 adult women with comorbid migraine and overweight/obesity who received 16 weeks of either']","['behavioral weight loss (BWL) treatment and migraine education (ME', 'BWL or ME']","['pain acceptance', 'pain acceptance and change in headache disability', 'headache frequency', 'headache disability', 'Pain Acceptance and Headache-Related Disability', 'migraine frequency, headache duration, and pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",110.0,0.126467,"RESULTS


BWL and ME did not differ on improvement in pain acceptance from baseline across post-treatment and follow-up.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Rathier', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Roth', 'Affiliation': 'Department of Neurology, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Psychiatry and Human Behavior, The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay076']
2913,30252113,The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial.,"OBJECTIVE


Women with chronic urogenital pain (CUP) conditions have elevated rates of lifetime trauma, relational stress, and emotional conflicts, but directly assessing and treating psychological stress is rarely done in women's health care settings. We developed and tested the effects on patients' somatic and psychological symptoms of a life stress interview that encourages disclosure about stressors and uses experiential techniques to increase awareness of links between stress, emotions, and symptoms.
METHODS


In this randomized trial, women with CUP recruited at a multidisciplinary women's urology center received either a single 90-minute life stress interview (N = 37) or no interview (treatment-as-usual control; N = 25). Self-report measures of pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression) were completed at baseline and six-week follow-up.
RESULTS


Differences between the life stress interview and control conditions at follow-up were tested with analyses of covariance, controlling for baseline level of the outcome and baseline depression. Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
CONCLUSIONS


An intensive life stress emotional awareness expression interview improved physical but not psychological symptoms among women with CUP seen in a tertiary care clinic. This study suggests that targeting stress and avoided emotions and linking them to symptoms may be beneficial for this complex group of patients.",2019,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
","['Objective\n\n\nWomen with chronic urogenital pain (CUP', ""women with CUP recruited at a multidisciplinary women's urology center received either a"", 'Women with Chronic Urogenital Pain', 'women with CUP seen in a tertiary care clinic']","['Life Stress Emotional Awareness and Expression Interview', 'single 90-minute life stress interview (N\u2009=\u200937) or no interview (treatment-as-usual control; N\u2009=\u200925']","['pain severity and pelvic floor symptoms', 'pain interference or psychological symptoms', 'pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression', 'awareness of links between stress, emotions, and symptoms']","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.101268,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms.
","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Carty', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tomakowsky', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Health / Providence-Providence Park Hospital, Michigan State University College of Human Medicine, Southfield, Michigan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny182']
2914,31953303,"Randomized, Controlled Trial of Tacrolimus and Prednisolone Monotherapy for Adults with  De Novo  Minimal Change Disease: A Multicenter, Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES


Minimal change disease is an important cause of nephrotic syndrome in adults. Corticosteroids are first-line therapy for minimal change disease, but a prolonged course of treatment is often required and relapse rates are high. Patients with minimal change disease are therefore often exposed to high cumulative corticosteroid doses and are at risk of associated adverse effects. This study investigated whether tacrolimus monotherapy without corticosteroids would be effective for the treatment of  de novo  minimal change disease.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This was a multicenter, prospective, open-label, randomized, controlled trial involving six nephrology units across the United Kingdom. Adult patients with first presentation of minimal change disease and nephrotic syndrome were randomized to treatment with either oral tacrolimus at 0.05 mg/kg twice daily, or prednisolone at 1 mg/kg daily up to 60 mg daily. The primary outcome was complete remission of nephrotic syndrome after 8 weeks of therapy. Secondary outcomes included remission of nephrotic syndrome at 16 and 26 weeks, rates of relapse of nephrotic syndrome, and changes from baseline kidney function.
RESULTS


There were no significant differences between the tacrolimus and prednisolone treatment cohorts in the proportion of patients in complete remission at 8 weeks (21 out of 25 [84%] for prednisolone and 17 out of 25 [68%] for tacrolimus cohorts;  P =0.32; difference in remission rates was 16%; 95% confidence interval [95% CI], -11% to 40%), 16 weeks (23 out of 25 [92%] for prednisolone and 19 out of 25 [76%] for tacrolimus cohorts;  P =0.25; difference in remission rates was 16%; 95% CI, -8% to 38%), or 26 weeks (23 out of 25 [92%] for prednisolone and 22 out of 25 [88%] for tacrolimus cohorts;  P =0.99; difference in remission rates was 4%; 95% CI, -17% to 25%). There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission  (P =0.99) or in the time from complete remission to relapse.
CONCLUSIONS


Tacrolimus monotherapy can be effective alternative treatment for patients wishing to avoid steroid therapy for minimal change disease.
PODCAST


This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_01_16_CJN06180519.mp3.",2020,"There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission  (P =0.99), or in the time from complete remission to relapse.
","['Adults with  De Novo', 'patients wishing to avoid steroid therapy for minimal change disease', 'six nephrology units across the United Kingdom', 'Adult patients with first presentation of minimal change disease and nephrotic syndrome', 'nephrotic syndrome in adults', 'Patients with minimal change disease']","['prednisolone', 'tacrolimus monotherapy without corticosteroids', 'Corticosteroids', 'oral tacrolimus', 'Tacrolimus and Prednisolone Monotherapy', 'PODCAST']","['complete remission of nephrotic syndrome', 'relapse rates', 'Minimal Change Disease', 'remission rates', 'rates of relapse of nephrotic syndrome, and changes from baseline kidney function', 'remission of nephrotic syndrome', 'complete remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0439629', 'cui_str': 'First presentation (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.353176,"There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission  (P =0.99), or in the time from complete remission to relapse.
","[{'ForeName': 'Nicholas Rhys', 'Initials': 'NR', 'LastName': 'Medjeral-Thomas', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'The Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Condon', 'Affiliation': 'South West Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, Epsom, United Kingdom.'}, {'ForeName': 'Bhrigu', 'Initials': 'B', 'LastName': 'Sood', 'Affiliation': 'South West Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, Epsom, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Warwicker', 'Affiliation': 'The Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Pattison', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Barratt', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom; and.'}, {'ForeName': 'H Terence', 'Initials': 'HT', 'LastName': 'Cook', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Levy', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lightstone', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Galliford', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cairns', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom; m.e.griffith@ic.ac.uk.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06180519']
2915,32034070,Screening for CKD To Improve Processes of Care among Nondiabetic Veterans with Hypertension: A Pragmatic Cluster-Randomized Trial.,"BACKGROUND AND OBJECTIVES


We conducted a pilot, pragmatic, cluster-randomized trial to evaluate feasibility and preliminary effectiveness of screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio), followed by education and guidance, to improve care of hypertensive veterans in primary care. We used the electronic health record for identification, enrollment, intervention delivery, and outcome ascertainment.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We randomized 1819 veterans without diabetes but with hypertension (41 clusters) into three arms: ( 1 ) CKD screening followed by patient and provider education; ( 2 ) screening, education, plus pharmacist comanagement; or ( 3 ) usual care. The primary clinical outcome was BP change over 1 year. Implementation and process measures included proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics.
RESULTS


Median age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure. Among those in the intervention, 527 of 1215 (43%) were identified with upcoming appointments to have CKD screening. Of these, 367 (69%) completed testing. Among those tested, 77 (21%) persons had newly diagnosed CKD. After 1 year, change in systolic BP was -1 mm Hg (interquartile range, -11 to 11) in usual care, -2 mm Hg (-11 to 11) in the screen-educate arm, and -2 mm Hg (-13 to 10) in the screen-educate plus pharmacist arm;  P =0.49. There were no significant differences in secondary outcomes in intention-to-treat analyses. In as-treated analyses, higher proportions of participants in the intervention arms initiated a renin-angiotensin system inhibitor (15% and 12% versus 7% in usual care,  P =0.01) or diuretic (9% and 12% versus 4%,  P =0.03).
CONCLUSIONS


The pragmatic design made identification, enrollment, and intervention delivery highly efficient. The limited ability to identify appointments resulted in inadequate between-arm differences in CKD testing rates to determine whether screening improves clinical outcomes.",2020,There were no significant differences in secondary outcomes in intention-to-treat analyses.,"['Median age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure', '1819 veterans without diabetes but with hypertension (41 clusters) into three arms: ( 1 ', 'Nondiabetic Veterans with Hypertension', 'hypertensive veterans in primary care', '77 (21%) persons had newly diagnosed CKD']","['CKD', 'screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio', 'CKD screening followed by patient and provider education; ( 2 ) screening, education, plus pharmacist comanagement; or ( 3 ) usual care']","['BP change over 1 year', 'systolic BP', 'proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics', 'renin-angiotensin system inhibitor']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}]",1819.0,0.118981,There were no significant differences in secondary outcomes in intention-to-treat analyses.,"[{'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Peralta', 'Affiliation': 'Division of Nephrology, carmenalicia.peralta@ucsf.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frigaard', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Rolon', 'Affiliation': 'Division of Nephrology.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Seal', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Tuot', 'Affiliation': 'Division of Nephrology.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Senyak', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Division of Nephrology.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Powe', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scherzer', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Chao', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Chiao', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Rubinsky', 'Affiliation': 'Department of Medicine.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.05050419']
2916,32132826,The Impact of Eye-closed and Weighted Multi-ball Training on the Improvement of the Stroke Effect of Adolescent Table Tennis Players.,"This paper investigated the impact of eye-closed and weighted training (EWMT) on the stroke effect of adolescent table tennis players. Forty-eight adolescent table tennis players were randomly selected from the China Table Tennis College and were divided into two groups as 1) the experimental group (EG, n = 24) in which they engaged in multi-ball exercise with eye-closed and weighted swing for 10 weeks, and 2) the control group (CG, n = 24) in which they received a normal training without eye-closed and weighted swing intervention. The stroke effect was assessed by three outcome measures: accuracy, stability, and ball speed. Results showed that 1) both the traditional training method and EWMT can improve the stroke effect of adolescent table tennis players. 2) In terms of accuracy, the number of stroke in the corner area was significantly different between EG and CG after the experiment (p = 0.022, p < 0.001, respectively). 3) In terms of stroke stability, there was a significant difference in the number of net ball strokes between EG and CG after the experiment (p = 0.014). 4) In terms of ball speed, there was no significant difference between EG and CG after the experiment (p = 0.871). 5) After EWMT, the stroke stability of backspin had more significant improvement than that of topspin. Thus, compared with the traditional training method, the EWMT method can improve the stroke effect of adolescent table tennis players in terms of accuracy and stability more significantly; the EWMT method can improve the stroke effect of backspin more significantly than that of topspin in terms of stability.",2020,"In terms of accuracy, the number of stroke in the corner area was significantly different between EG and CG after the experiment (p = 0.022, p < 0.001, respectively).","['adolescent table tennis players', 'Forty-eight adolescent table tennis players were randomly selected from the China Table Tennis College', 'Adolescent Table Tennis Players']","['eye-closed and weighted training (EWMT', 'Eye-closed and Weighted Multi-ball Training', 'EWMT', 'experimental group (EG, n = 24) in which they engaged in multi-ball exercise with eye-closed and weighted swing for 10 weeks, and 2) the control group (CG, n = 24) in which they received a normal training without eye-closed and weighted swing intervention']","['accuracy, stability, and ball speed', 'stroke effect of backspin', 'stroke effect', 'number of stroke in the corner area', 'number of net ball strokes', 'stroke stability of backspin']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",48.0,0.022179,"In terms of accuracy, the number of stroke in the corner area was significantly different between EG and CG after the experiment (p = 0.022, p < 0.001, respectively).","[{'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'China Table Tennis College, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'China Table Tennis College, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'China Table Tennis College, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'China Table Tennis College, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'China Table Tennis College, Shanghai University of Sport, Shanghai, China.'}]",Journal of sports science & medicine,[]
2917,29985968,"Intervention Effects of ""Girls on the Move"" on Increasing Physical Activity: A Group Randomized Trial.","BACKGROUND


Limited intervention success in increasing and sustaining girls' moderate-to-vigorous physical activity (MVPA) underscores a need for continued research.
PURPOSE


The aim of this study was to evaluate the effect of a 17-week Girls on the Move (GOTM) intervention on increasing MVPA among fifth- to eighth-grade girls.
METHODS


This study is a group (cluster) randomized trial, including 24 schools, pair matched and assigned to intervention (n = 12) or control (n = 12) conditions. Participants included 1,519 girls in racially diverse public schools in urban, underserved areas of the Midwestern USA. The intervention included three components: (i) 90-min after-school physical activity (PA) club offered 3 days/week; (ii) two motivational, individually tailored counseling sessions; and (iii) an interactive Internet-based session at the midpoint of the intervention. Main outcome measures were weighted mean minutes of MVPA per week post-intervention and at 9-month follow-up measured via accelerometer.
RESULTS


No between-group differences occurred for weighted mean minutes of MVPA per week at post-intervention (B = -0.08, p = .207) or 9-month follow-up (B = -0.09, p = .118) while controlling for baseline MVPA.
CONCLUSIONS


Research is needed to identify interventions that assist girls in attaining and maintaining adequate PA.
CLINICALTRIALS.GOV IDENTIFIER


NCT01503333.",2019,"No between-group differences occurred for weighted mean minutes of MVPA per week at post-intervention (B = -0.08, p = .207) or 9-month follow-up (B =","['24 schools, pair matched and assigned to intervention (n = 12) or control (n = 12) conditions', 'Participants included 1,519 girls in racially diverse public schools in urban, underserved areas of the Midwestern USA', 'Girls', 'fifth- to eighth-grade girls', '17-week Girls']","['Move (GOTM) intervention', '90-min after-school physical activity (PA) club offered 3 days/week; (ii) two motivational, individually tailored counseling sessions; and (iii) an interactive Internet-based session at the midpoint of the intervention']","['weighted mean minutes of MVPA per week post-intervention and at 9-month follow-up measured via accelerometer', 'Physical Activity']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",1519.0,0.0603895,"No between-group differences occurred for weighted mean minutes of MVPA per week at post-intervention (B = -0.08, p = .207) or 9-month follow-up (B =","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Dhruv B', 'Initials': 'DB', 'LastName': 'Sharma', 'Affiliation': 'Center for Statistical Training and Consulting, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Dalimonte-Merckling', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Vicki R', 'Initials': 'VR', 'LastName': 'Voskuil', 'Affiliation': 'Department of Nursing, A. Paul Schaap Science Center, Hope College, Holland, MI, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Department of Biostatistics and Center for Human Growth and Development (CHGD), University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Kinesiology, College of Education, Michigan State University, East Lansing, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay054']
2918,32078787,New Nutraceutical Combination Reduces Blood Pressure and Improves Exercise Capacity in Hypertensive Patients Via a Nitric Oxide-Dependent Mechanism.,"Background High blood pressure (BP) has long been recognized as a major health threat and, particularly, a major risk factor for stroke, cardiovascular disease, and end-organ damage. However, the identification of a novel, alternative, integrative approach for the control of BP and cardiovascular protection is still needed. Methods and Results Sixty-nine uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in 2 double-blind studies. Forty-five were randomized to placebo or a new nutraceutical combination named AkP05, and BP, endothelial function, and circulating nitric oxide were assessed before and at the end of 4 weeks of treatment. Twenty-four patients were randomized to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems. Vascular and molecular studies were undertaken on mice to characterize the action of the single compounds contained in the AkP05 nutraceutical combination. AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output. In mice, AkP05 reduced BP and improved endothelial function, evoking increased nitric oxide release through the PKCα/Akt/endothelial nitric oxide synthase pathway and reducing reactive oxygen species production via NADPH-oxidase inhibition. These effects were mediated by synergism of the single compounds of AkP05. Conclusions This is the first study reporting positive effects of a nutraceutical combination on the vasculature and exercise tolerance in treated hypertensive patients. Our findings suggest that AkP05 may be used as an adjunct for the improvement of cardiovascular protection and to better control BP in uncontrolled hypertension.",2020,"AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output.","['Sixty-nine uncontrolled hypertension patients, aged 40 to 68\xa0years, on antihypertensive medication were enrolled in 2 double-blind studies', 'Hypertensive Patients', 'Forty-five were randomized to', 'treated hypertensive patients']","['cardiopulmonary exercise test', 'placebo', 'diuretic or AkP05', ' High blood pressure (BP', 'nutraceutical combination']","['BP and improved endothelial function', 'Blood Pressure and Improves Exercise Capacity', 'maximum O 2  uptake, stress tolerance, and maximal power output', 'BP, endothelial function, and circulating nitric oxide', 'vasculature and exercise tolerance', 'BP, improved endothelial function']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0520943', 'cui_str': 'Stress tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005839', 'cui_str': 'vasculature'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",69.0,0.118934,"AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O 2  uptake, stress tolerance, and maximal power output.","[{'ForeName': 'Albino', 'Initials': 'A', 'LastName': 'Carrizzo', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Moltedo', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Damato', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Katiuscia', 'Initials': 'K', 'LastName': 'Martinello', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Di Pietro', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Oliveti', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Acernese', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giugliano', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Izzo', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sommella', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Migliarino', 'Affiliation': 'Department of Clinical and Molecular Medicine School of Medicine and Psychology Sapienza University of Rome Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Piazza', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Izzo', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Virtuoso', 'Affiliation': 'Department of Cardiovascular Medicine A.O.U. Federico II Naples Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Strianese', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Trimarco', 'Affiliation': 'Department of Advanced Biomedical Sciences Federico II University Hospital Naples Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Campiglia', 'Affiliation': 'Department of Pharmacy University of Salerno Fisciano Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Puca', 'Affiliation': 'Department of Medicine and Surgery University of Salerno Baronissi Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Trimarco', 'Affiliation': 'Department of Advanced Biomedical Sciences University Federico II of Naples Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Vecchione', 'Affiliation': 'IRCCS Neuromed Pozzilli Italy.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014923']
2919,32087257,The influence of prolonged temperature management on acute kidney injury after out-of-hospital cardiac arrest: A post hoc analysis of the TTH48 trial.,"BACKGROUND


Acute kidney injury (AKI) is common after cardiac arrest and targeted temperature management (TTM). The impact of different lengths of cooling on the development of AKI has not been well studied. In this study of patients included in a randomised controlled trial of TTM at 33 °C for 24 versus 48 h after cardiac arrest (TTH48 trial), we examined the influence of prolonged TTM on AKI and the incidence and factors associated with the development of AKI. We also examined the impact of AKI on survival.
METHODS


This study was a sub-study of the TTH48 trial, which included patients cooled to 33 ± 1 °C after out-of-hospital cardiac arrest for 24 versus 48 h. AKI was classified according to the KDIGO AKI criteria based on serum creatinine and urine output collected until ICU discharge for a maximum of seven days. Survival was followed for up to six months. The association of admission factors on AKI was analysed with multivariate analysis and the association of AKI on mortality was analysed with Cox regression using the time to AKI as a time-dependent covariate.
RESULTS


Of the 349 patients included in the study, 159 (45.5%) developed AKI. There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-h groups. Serum creatinine values had significantly different trajectories for the two groups with a sharp rise occurring during rewarming. Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index were independent predictors of AKI. Patients with AKI had a higher mortality than patients without AKI (hospital mortality 36.5% vs 12.5%, p < 0.001), but only AKI stages 2 and 3 were independently associated with mortality.
CONCLUSIONS


We did not find any association between prolonged TTM at 33 °C and the risk of AKI during the first seven days in the ICU. AKI is prevalent after cardiac arrest and TTM and occurs in almost half of all ICU admitted patients and more commonly in the elderly, with an increasing BMI and longer arrest duration. AKI after cardiac arrest is an independent predictor of time to death.",2020,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","['TTH48 trial, which included patients cooled to 33±1˚C after out-of-hospital cardiac arrest for 24 versus 48hours', '349 patients included in the study, 159 (45.5%) developed AKI', 'acute kidney injury after out-of-hospital cardiac arrest']","['prolonged temperature management', 'TTM']","['higher mortality', 'mortality', 'Serum creatinine values', 'Survival', 'incidence, severity or time to AKI', 'Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",349.0,0.11476,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Intensive Care, Stavanger University Hospital, Norway. Electronic address: kristian.strand@sus.no.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway; Department Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Belgium.'}, {'ForeName': 'Anders Morten', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-University, Berlin, Germany.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, Helsinki University Hospital, Finland.'}]",Resuscitation,['10.1016/j.resuscitation.2020.01.039']
2920,31855102,Responsiveness Evaluation and Recommendation for Responder Thresholds for Endometriosis Health Profile-30: Analysis of Two Phase III Clinical Trials.,"Objective:  To evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) and ascertain score changes that are indicative of response to treatment. A  post hoc  analysis of two Phase III, double-blind, placebo-controlled, randomized clinical trials among women with moderate-to-severe endometriosis-associated pain (Elaris Endometriosis I and II [EM-I and EM-II]).  Materials and Methods:  EHP-30 core items and sexual relationship module were administered at day 1, month 3 (M3), and month 6 (M6) to monitor patient-reported impacts of endometriosis-related pain. A seven-response level Patient Global Impression of Change (PGIC) was administered at M3 and M6. Dysmenorrhea (DYS), nonmenstrual pelvic pain (NMPP), and dyspareunia (DYSP) were collected using a daily diary. Three psychometric approaches, ""triangulation,"" were used to suggest responder thresholds for the EHP-30 domains. The three approaches were anchor- and distribution-based analyses and use of clinically relevant indicators (DYS, NMPP, DYSP).  Results:  EM-I and EM-II enrolled 871 and 815 women, respectively. All EHP-30 domains improved during the trials (M3, M6). Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements. Large effect sizes were noted for all EHP-30 domains (EM-I range -0.59 to -1.80; EM-II range -0.52 to -1.59). EHP-30 thresholds of meaningful change ranged from -20 to -35, with greater changes indicating greater improvement in health status.  Conclusion:  Responder thresholds by EHP-30 domain are recommended to evaluate treatment efficacy. Clinicians can individualize goals of treatment by EHP-30 domain and track changes using the EHP-30.",2020,"Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements.","['EM-I and EM-II enrolled 871 and 815 women, respectively', 'Endometriosis Health Profile-30', 'women with moderate-to-severe endometriosis-associated pain (Elaris Endometriosis I and II']",['placebo'],"['EHP-30 improvements', 'Dysmenorrhea (DYS), nonmenstrual pelvic pain (NMPP), and dyspareunia (DYSP', 'health status']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",815.0,0.102285,"Differences ( p  < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois.'}, {'ForeName': 'Huge S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Patient-Centered Research, Bethesda, Maryland.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7788']
2921,32060930,Titrating a modified ketogenic diet for patients with McArdle disease: A pilot study.,"Glycogen storage disease type V (GSDV) is a rare inborn error of carbohydrate metabolism. Patients present with exercise intolerance due to blocked glycogen breakdown in skeletal muscle. Introducing alternative fuel substrates, such as ketone bodies (KBs), could potentially alleviate muscle symptoms. This pilot study investigates which of three different modified ketogenic diet regimes is optimal for GSDV-patients to follow in a future large-scale study. Participants were randomised to follow one of three diet regimes for 3 weeks (#1: 65%/15%/20%; #2: 75%/15%/10%, or #3: 80%/15%/5%, fat/protein/carbohydrate). The primary outcome was exercise tolerance assessed by heart rate (HR) changes during constant load cycling. Secondary outcomes included levels of ketosis, and changes in perceived exertion and indirect calorimetry measures during exercise. Ten GSDV-patients were included. Eight completed the study. The other two were excluded. Diet #3 showed the highest average KB level (1.1 mmol/L) vs #2 (0.5 mmol/L) and #1 (0.3 mmol/L). Five patients reported subjective symptom relief, all of whom were on diets #2 and #3. All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion. The results of this open-label pilot study show that diets #2 and #3 induce ketosis and improve symptoms and exercise capacity in GSDV-patients. Diet #2 had the highest acceptability score and was superior or equal to diet #3 in all other parameters, except level of ketosis. Based on this, we suggest testing diet #2 in a large-scale, placebo-controlled study in GSDV.",2020,All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion.,"['patients with McArdle disease', 'GSDV-patients', 'Ten GSDV-patients were included']","['fat/protein/carbohydrate', 'Titrating a modified ketogenic diet']","['levels of ketosis, and changes in perceived exertion and indirect calorimetry measures during exercise', 'highest acceptability score', 'HR and perceived exertion', 'exercise tolerance assessed by heart rate (HR) changes during constant load cycling', 'subjective symptom relief', 'fatty acid oxidation rates and exercise capacity', 'symptoms and exercise capacity', 'Glycogen storage disease type V (GSDV', 'highest average KB level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017924', 'cui_str': 'Myophosphorylase deficiency'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017924', 'cui_str': 'Myophosphorylase deficiency'}]",,0.0281232,All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion.,"[{'ForeName': 'Nicoline', 'Initials': 'N', 'LastName': 'Løkken', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Hansen', 'Affiliation': 'The Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Storgaard', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mette C', 'Initials': 'MC', 'LastName': 'Ørngreen', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'The Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12223']
2922,32001783,Whole-body vibration modulates leg muscle reflex and blood perfusion among people with chronic stroke: a randomized controlled crossover trial.,"This study aimed to investigate the acute effect of whole-body vibration (WBV) on the reflex and non-reflex components of spastic hypertonia and intramuscular blood perfusion among individuals with chronic stroke. Thirty-six people with chronic stroke (age: 61.4 ± 6.9 years) participated in this randomized controlled cross-over study. Each participant underwent two testing conditions: static standing for 5 minutes with WBV (30 Hz, 1.5 mm) or no-vibration. We assessed the soleus H-reflex, shear modulus (ultrasound elastography) and vascular index (color power Doppler ultrasound) of the medial gastrocnemius (MG) muscle on either paretic or non-paretic side at baseline and every 1-min post-intervention up to 5 minutes. The results revealed a significant inhibition of the H/M ratio bilaterally for the WBV condition (absolute change on paretic side: 0.61 ± 0.35, p = 0.001; non-paretic side: 0.34 ± 0.23, p = 0.001), but not the control condition. The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively. The vascular index of MG muscle was significantly increased only for the WBV condition [paretic: from 0.55 ± 0.07 to 1.08 ± 0.18 (p = 0.001); non-paretic: from 0.82 ± 0.09 to 1.01 ± 0.13 (p < 0.001)], which lasted for 3 minutes and 5 minutes, respectively. No significant change of the shear modulus in the MG muscle was observed, regardless of the testing condition. Based on our results, WBV had an acute effect on modulating spastic hypertonia dominated by hyperreflexia in people with chronic stroke and facilitating greater intramuscular blood perfusion. No acute effect on passive muscle stiffness was observed.",2020,"The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively.","['Thirty-six people with chronic stroke (age: 61.4\u2009±\u20096.9 years', 'people with chronic stroke', 'individuals with chronic stroke']","['static standing for 5\u2009minutes with WBV (30\u2009Hz, 1.5\u2009mm) or no-vibration', 'whole-body vibration (WBV', 'Whole-body vibration modulates leg muscle reflex and blood perfusion']","['spastic hypertonia', 'soleus H-reflex, shear modulus (ultrasound elastography) and vascular index (color power Doppler ultrasound) of the medial gastrocnemius (MG) muscle on either paretic or non-paretic side', 'intramuscular blood perfusion', 'shear modulus', 'vascular index of MG muscle', 'passive muscle stiffness', 'inhibition of H-reflex']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0026826', 'cui_str': 'Hypermyotonia'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C3163956', 'cui_str': 'Ultrasound elastography'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1960437', 'cui_str': 'Power doppler ultrasound'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",36.0,0.0244558,"The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively.","[{'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Tiev', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ying', 'Affiliation': 'Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Marco Y C', 'Initials': 'MYC', 'LastName': 'Pang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong. marco.pang@polyu.edu.hk.'}]",Scientific reports,['10.1038/s41598-020-58479-5']
2923,32088687,Efficacy of infection control pathway in reducing postoperative infections in patients undergoing neurosurgery.,"INTRODUCTION


The environment of the operating room (OR) is closely related to the postoperative complications of patients, and it is necessary to study, to what extent, the stringent management of the OR can reduce postoperative complications.
METHODOLOGY


426 patients who underwent surgery between January 2016 and December 2017 were selected from two class-100 laminar flow ORs of equivalent area, and were divided into an experimental group and a control group.
RESULTS


The experimental group had significantly lower total air-borne bacterial count in the OR than the control group 10 minutes before surgery (6.21 ± 4.14 vs. 11.58 ± 5.36 CFU/cm3), 10 minutes (15.67 ± 6.21 vs. 20.83 ± 5.78 CFU/cm3), 30 minutes (27.34 ± 8.18 vs. 39.56 ± 7.86 CFU/cm3) and 60 minutes (43.62 ± 7.66 vs. 51.63 ± 8.43 CFU/cm3) into surgery, and at the end of surgery (57.34 ± 7.67 vs. 69.33 ± 9.41 CFU/cm3) (all p < 0.05). The incidence rates of increased body temperature and leukocyte count 3 days post-surgery, and the duration of antibiotic therapy and hospital stay were significantly reduced in the experimental group compared to the control group (all p < 0.05). Furthermore, the total number of pathogens in the incision at 2 hours into surgery was also significantly lower in the experimental group than in the control group (p < 0.05).
CONCLUSION


Stringent application of the infection control pathway is an efficacious measure for improving the air cleanliness of the neurosurgery OR, decreasing the incidence rates of postoperative complications and infection, as well as controlling pathogen transmission.",2020,"The experimental group had significantly lower total air-borne bacterial count in the OR than the control group 10 minutes before surgery (6.21 ± 4.14 vs. 11.58 ± 5.36 CFU/cm3), 10 minutes (15.67 ± 6.21 vs. 20.83 ± 5.78 CFU/cm3), 30 minutes (27.34 ± 8.18 vs. 39.56 ± 7.86 CFU/cm3) and 60 minutes (43.62 ± 7.66 vs. 51.63 ± 8.43 CFU/cm3) into surgery, and at the end of surgery (57.34 ± 7.67 vs. 69.33 ± 9.41 CFU/cm3) (all p < 0.05).","['patients undergoing neurosurgery', '426 patients who underwent surgery between January 2016 and December 2017 were selected from two class-100 laminar flow ORs of equivalent area']",['infection control pathway'],"['duration of antibiotic therapy and hospital stay', 'postoperative infections', 'incidence rates of increased body temperature and leukocyte count', 'total number of pathogens', 'total air-borne bacterial count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205274', 'cui_str': 'Laminar (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0085557', 'cui_str': 'Infection Control'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0004618', 'cui_str': 'Bacterial Count'}]",,0.0137965,"The experimental group had significantly lower total air-borne bacterial count in the OR than the control group 10 minutes before surgery (6.21 ± 4.14 vs. 11.58 ± 5.36 CFU/cm3), 10 minutes (15.67 ± 6.21 vs. 20.83 ± 5.78 CFU/cm3), 30 minutes (27.34 ± 8.18 vs. 39.56 ± 7.86 CFU/cm3) and 60 minutes (43.62 ± 7.66 vs. 51.63 ± 8.43 CFU/cm3) into surgery, and at the end of surgery (57.34 ± 7.67 vs. 69.33 ± 9.41 CFU/cm3) (all p < 0.05).","[{'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. dongchunli99@163.com.""}, {'ForeName': 'Haozheng', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 651437910@qq.com.""}, {'ForeName': 'Renyan', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 847916825@qq.com.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 806043947@qq.com.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. creeks20002000@163.com.""}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': ""Department of Anesthesiology and Operation, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. creeks20002000@sina.com.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. zhangxin21521@163.com.""}]",Journal of infection in developing countries,['10.3855/jidc.11747']
2924,31322024,Effect of physical therapy on early knee osteoarthritis with medial meniscal posterior tear assessed by MRI T2 mapping and 3D-to-2D registration technique: A prospective intervention study.,"Objectives:  The purpose of this study was to verify that exercise aimed at improving knee kinematics in early-stage knee osteoarthritis (OA) patients with medial meniscus posterior root tears (MMPRTs) reduces knee adduction angle during gait and prevents rapid cartilage degeneration in the medial compartment of the knee. Methods:  Subjects were randomly assigned to an adapting alignment exercise (AAE) group, with the goal of improving knee kinematics, and a muscle training and exercise (MTE) group. Before the start of the six-month intervention and following its completion, we performed an analysis of knee kinematics during gait using a 3D-to-2D registration technique and identified the area of cartilage degeneration using MRI T2 mapping. Results:  The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039). The amount of change in the area of cartilage degeneration according to MRI T2 mapping expressed as MTE/AAE group was 7.7 mm 2  (-0.4, 15.8)/-2.7 mm 2  (-10.8, 5.3) at the posterior knee ( p  = .043). Conclusion:  AAE could be a potential treatment method that improves the natural course of knee OA with MMRPTs.",2020,"The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039).","['early knee osteoarthritis with medial meniscal posterior tear assessed by', 'early-stage knee osteoarthritis (OA) patients with medial meniscus posterior root tears (MMPRTs']","['MRI T2 mapping and 3D-to-2D registration technique', 'physical therapy', 'adapting alignment exercise (AAE) group, with the goal of improving knee kinematics, and a muscle training and exercise (MTE']",['knee kinematics'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.0731694,"The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039).","[{'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Ikuta', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, International University of Health and Welfare Hospital, Tochigi, Japan.'}, {'ForeName': 'Sanshiro', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'Minami-Shinjuku Orthopaedic Rehabilitation Clinic, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Yuzawa', 'Affiliation': 'Inanami Spine and Joint Hospital, Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Inanami', 'Affiliation': 'Inanami Spine and Joint Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinro', 'Initials': 'S', 'LastName': 'Takai', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1646193']
2925,31874212,Physiological-based cord clamping in very preterm infants - Randomised controlled trial on effectiveness of stabilisation.,"AIM


To test whether stabilising very preterm infants while performing physiological-based cord clamping (PBCC) is at least as effective as the standard approach of time-based delayed cord clamping (DCC).
METHODS


A randomised controlled non-inferiority study was performed in two centres from May until November 2018, including preterm infants born below 32 weeks of gestational age. Infants were allocated to PBCC or standard DCC. Infants receiving PBCC were stabilised on a purpose-built resuscitation table with an intact umbilical cord. The cord was clamped when the infant had regular spontaneous breathing, heart rate ≥100 bpm and SpO 2  >90% while using FiO 2  <0.40. In infants receiving DCC, the cord was clamped at 30-60 seconds after birth before they were transferred to the standard resuscitation table for further treatment and stabilisation. Primary outcome was time to reach respiratory stability.
RESULTS


Thirty-seven infants (mean gestational age 29 + 0 weeks) were included. Mean cord clamping time was 5:49 ± 2:37 min in the PBCC (n = 20) and 1:02 ± 0:30 min in the DCC group (n = 17). Infants receiving PBCC needed less time to reach respiratory stability (PBCC 5:54 ± 2:27 min; DCC 7:07 ± 2:54 min; mean difference corrected for gestational age -1:19 min, 95% CI [-3:04-0:27]), showing non-inferiority with the pre-defined limit of 1:15 min. No significant differences between the groups were found for maternal blood loss, postpartum haemorrhage, infant temperature at admission or short-term neonatal outcomes.
CONCLUSION


Stabilisation of very preterm infants with physiological-based cord clamping is at least as effective as with standard DCC.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register (NTR7194/NL7004).",2020,Mean cord clamping time was 5:49 ± 2:37 minutes in the PBCC (n = 20) and 1:02 ± 0:30 minutes in the DCC group (n = 17).,"['Thirty-seven infants (mean gestational age 29\u2009+\u20090 weeks) were included', 'two centres from May until November 2018, including preterm infants born below 32 weeks of gestational age']","['Physiological-based cord clamping', 'physiological-based cord clamping (PBCC', 'PBCC or standard DCC']","['Mean cord clamping time', 'maternal blood loss, postpartum haemorrhage, infant temperature at admission or short-term neonatal outcomes', 'time to reach respiratory stability']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",37.0,0.204745,Mean cord clamping time was 5:49 ± 2:37 minutes in the PBCC (n = 20) and 1:02 ± 0:30 minutes in the DCC group (n = 17).,"[{'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Knol', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Erasmus University Medical Centre, Rotterdam, The Netherlands; Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, The Netherlands. Electronic address: r.knol@erasmusmc.nl.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Brouwer', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'van den Akker', 'Affiliation': 'Department of Obstetrics, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'DeKoninck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus University Medical Centre, Rotterdam, The Netherlands; The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Graeme R', 'Initials': 'GR', 'LastName': 'Polglase', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Lopriore', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Herkert', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Hooper', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, The Netherlands.'}]",Resuscitation,['10.1016/j.resuscitation.2019.12.007']
2926,31870314,"A multicomponent exercise intervention to improve physical functioning, cognition and psychosocial well-being in elderly nursing home residents: a study protocol of a randomized controlled trial in the PROCARE (prevention and occupational health in long-term care) project.","BACKGROUND


Older adults, who are living in nursing homes that provide a high level of long-term nursing care, are characterized by multimorbidity and a high prevalence of dependency in activities of daily living. Results of recent studies indicate positive effects of structured exercise programs during long-term care for physical functioning, cognition, and psychosocial well-being. However, for frail elderly the evidence remains inconsistent. There are no evidence-based guidelines for exercises for nursing home residents that consider their individual deficits and capacities. Therefore, high-quality studies are required to examine the efficacy of exercise interventions for this multimorbid target group. The purpose of this study is to determine the feasibility and efficacy of a multicomponent exercise intervention for nursing home residents that aims to improve physical and cognitive functioning as well as quality of life.
METHODS


A two-arm single-blinded multicenter randomized controlled trial will be conducted, including 48 nursing homes in eight regions of Germany with an estimated sample size of 1120 individuals. Participants will be randomly assigned to either a training or a waiting time control group. For a period of 16 weeks the training group will meet twice a week for group-based sessions (45-60 min each), which will contain exercises to improve physical functioning (strength, endurance, balance, flexibility) and cognitive-motor skills (dual-task). The intervention is organized as a progressive challenge which is successively adapted to the residents' capacities. Physical functioning, cognitive performance, and quality of life will be assessed in both study groups at baseline (pre-test), after 16-weeks (post-treatment), and after 32-weeks (retention test, intervention group only).
DISCUSSION


This study will provide information about the efficacy of a multicomponent exercise program in nursing homes (performance, recruitment). Results from this trial will contribute to the evidence of multicomponent exercises, which specifically focus on cognitive-motor approaches in the maintenance of mental and physical functioning. In addition, it will help to encourage older adults to actively engage in social life. Furthermore, the findings will lead to recommendations for health promotion interventions for frail nursing home residents.
TRIAL REGISTRATION


The trial was prospectively registered at DRKS.de with the registration number DRKS00014957 on October 9, 2018.",2019,"Results of recent studies indicate positive effects of structured exercise programs during long-term care for physical functioning, cognition, and psychosocial well-being.","['frail nursing home residents', 'nursing home residents', '48 nursing homes in eight regions of Germany with an estimated sample size of 1120 individuals', 'elderly nursing home residents', 'Older adults']","['multicomponent exercise program', 'training or a waiting time control group', 'multicomponent exercise intervention']","['quality of life', 'physical functioning, cognition and psychosocial well-being', 'physical and cognitive functioning', 'Physical functioning, cognitive performance, and quality of life', 'physical functioning (strength, endurance, balance, flexibility) and cognitive-motor skills (dual-task']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",1120.0,0.0655062,"Results of recent studies indicate positive effects of structured exercise programs during long-term care for physical functioning, cognition, and psychosocial well-being.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cordes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany. thomas.cordes@uni-hamburg.de.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bischoff', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Schott', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Meixner', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Luisa-Marie', 'Initials': 'LM', 'LastName': 'Appelles', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bebenek', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Berwinkel', 'Affiliation': 'Department of Sport & Health Sciences, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hildebrand', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jöllenbeck', 'Affiliation': 'Department of Sport & Health Sciences, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Johnen', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klotzbier', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Korbus', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rudisch', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Institute of Sports Sciences, Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weigelt', 'Affiliation': 'Department of Sport & Health Sciences, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wittelsberger', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Zwingmann', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany.'}]",BMC geriatrics,['10.1186/s12877-019-1386-6']
2927,31085814,Vitamin D does not modulate immune-mediated bone loss during ART initiation.,"BACKGROUND


Vitamin D (VitD) and calcium (Ca) supplementation attenuates antiretroviral therapy (ART)-associated bone loss, but it is unclear whether this effect is mediated through immunomodulation.
METHODS


In this exploratory analysis of A5280, a 48-week, randomized, double-blind, placebo-controlled study of VitD/Ca supplementation with ART initiation, we characterized lymphocyte phenotypes and receptor activator of nuclear factor kappa-B ligand (RANKL) expression by median fluorescence intensity (MFI) at baseline and 48 weeks. Changes were evaluated within and between treatment groups by Wilcoxon signed rank and rank sum tests, respectively. Spearman correlations estimated relationships between cellular phenotypes and bone mineral density (BMD).
RESULTS


Of 165 participants enrolled, 138 had samples for cellular phenotypes (64 VitD/Ca, 74 placebo). Markers of CD4, CD8 activation (CD38 + HLA-DR + ) declined (all P<0.001), but did not differ between arms. There was no decline in either %T-cells (CD4 and CD8) expressing RANKL or expression of RANKL by MFI. CD4 and CD8 activation markers were not correlated with BMD at baseline (r<0.15 and P>0.09 for all), but greater declines in CD4 activation correlated with greater declines in hip and spine BMD in both arms (0.25 ≤r ≤0.37, all P<0.05). A greater decline in CD8 activation was correlated with greater declines in both hip and spine BMD in the placebo arm only (hip r=0.31, P=0.009; spine r=0.25, P=0.035).
CONCLUSIONS


Reductions in T-cell activation are characteristic of ART initiation, but only correlated modestly with bone loss. VitD/Ca supplementation does not appear to mitigate bone loss through modulation of immune activation or expression of RANKL.
TRIAL REGISTRATION NUMBER


NCT01403051.",2019,"Markers of CD4, CD8 activation (CD38 + HLA-DR + ) declined (all p <0.001), but did not differ between arms.","['165 participants enrolled, 138 had samples for cellular phenotypes (64 VitD/Ca, 74 placebo']","['Vitamin D', 'VitD/Ca supplementation', 'Vitamin D (VitD) and calcium(Ca) supplementation', 'placebo']","['T cells (CD4 and CD8) expressing RANKL or expression of RANKL by MFI', 'CD8 activation', 'CD4 and CD8 activation markers', 'RANKL) expression by median fluorescence intensity (MFI', 'CD4 activation', 'bone mineral density (BMD', 'Markers of CD4, CD8 activation (CD38 + HLA-DR + ', 'hip and spine BMD']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}]",165.0,0.47542,"Markers of CD4, CD8 activation (CD38 + HLA-DR + ) declined (all p <0.001), but did not differ between arms.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics, Harvard Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kinslow', 'Affiliation': 'Department of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Martinson', 'Affiliation': 'Department of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Department of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Melbourne', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Department of Biostatistics, Harvard Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Antiviral therapy,['10.3851/IMP3316']
2928,31402718,"Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial.","Background:  Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line medications in mild-to-moderate acute pain. However, comparative data regarding the duration of analgesia for commonly-used NSAIDs at non-prescription doses is lacking. This study evaluated the time to rescue medication following a single dose of naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo in subjects with moderate-to-severe post-surgical dental pain. Methods:  This single-center, randomized, double-blind, parallel group, placebo-controlled study included healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0-10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars. A single oral dose of NAPSO (440 mg), IBU (400 mg), or placebo was administered. The primary efficacy endpoint was the time to first rescue medication, while secondary endpoints included the sum of pain intensity difference (SPID) and total pain relief (TOTPAR) over 24 h. ClinicalTrials.gov trial registration number: NCT03404206 (EudraCT 2017-005049-67). Results:  In the per protocol population ( n  = 385; mean age = 19 years), the time to rescue medication was significantly ( p  < .001) longer with NAPSO than IBU and placebo. After treatment, the greatest separation of NAPSO from IBU occurred at 9-14 h and from placebo at 1-6 h. Fewer NAPSO subjects required rescue medication (58/166, 34.9%) compared with IBU (137/165, 83.0%) and placebo (44/54, 81.5%). SPID 0-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo. Conclusions:  The duration of pain relief after a single dose of NAPSO was significantly longer than after IBU, and significantly fewer NAPSO-treated subjects required rescue medication over a 24-h period.",2019,-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo.  ,"['post-surgical dental pain', 'healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0-10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars', 'subjects with moderate-to-severe post-surgical dental pain']","['placebo', ':  Non-steroidal anti-inflammatory drugs (NSAIDs', 'naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo', 'naproxen sodium', 'ibuprofen', 'NAPSO']","['time to rescue medication', 'greatest separation of NAPSO from IBU', 'rescue medication', 'duration of pain relief', 'time to first rescue medication', 'sum of pain intensity difference (SPID) and total pain relief (TOTPAR']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.729776,-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo.  ,"[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Cooper', 'Affiliation': 'Stephen A. Cooper, DMD, PhD, LLC, Palm Beach Gardens, FL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Desjardins', 'Affiliation': 'Desjardins Associates, LLC, Maplewood, NJ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Brain', 'Affiliation': 'Jean Brown Research, Salt Lake City, UT, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Paredes-Diaz', 'Affiliation': 'Global Medical Affairs, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Troullos', 'Affiliation': 'Global Medical Affairs, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Centofanti', 'Affiliation': 'Clinical Development, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Biostatistics, Bayer Consumer Health, Whippany, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1655257']
2929,31112954,Outcomes of Desidustat Treatment in People with Anemia and Chronic Kidney Disease: A Phase 2 Study.,"BACKGROUND


Desidustat (ZYAN1) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that stimulates erythropoiesis. Stabilizing HIF via PHI is developing as a new therapeutic approach to treat anemia secondary to chronic kidney disease (CKD). This trial evaluated the safety, tolerability, and efficacy of Desidustat in adult CKD patients with anemia, who were not on dialysis.
METHODS


This was a Phase 2, randomized, double-blind, 6-week, placebo-controlled, dose-ranging, safety and efficacy study. A total of 117 eligible patients were randomized to 4 arms: 100, 150, 200 mg, or placebo. The investigational product was administered every alternate day for 6 weeks in fasting conditions. The primary endpoint was change in hemoglobin (Hb) from baseline to week 6.
RESULTS


Baseline demographics were well balanced among all the treatment arms. In the modified intent-to-treat (mITT) population, a mean Hb increase of 1.57, 2.22, and 2.92 g/dL in Desidustat 100, 150, and 200 mg arms, respectively, was observed post 6 weeks treatment. The responder rate (≥1 g/dL increase) was 66% in 100 mg, 75% in 150 mg, and 83% in 200 mg treatment arms, in the mITT population. Eighteen patients had at least one treatment emergent adverse event (TEAE), and 5 patients reported at least one drug-related mild TEAE. No death or serious adverse event was reported during the trial.
CONCLUSION


There was dose-related increase in Hb across all doses compared to placebo in mITT and per-protocol populations. Desidustat also increased pharmacokinetic parameters Cmax and AUC in dose-related manner. There was no significant change in vital signs, electrocardiographic parameters, or safety laboratory values. Clinical Trial Registration Number CTRI/2017/05/008534 (registered on May 11, 2017).",2019,"No death or serious adverse event was reported during the trial.
","['117 eligible patients', 'adult CKD patients with anemia, who were not on dialysis', 'People with Anemia and Chronic Kidney Disease', 'Eighteen patients had at least one treatment emergent adverse event (TEAE), and 5 patients reported at least one drug-related mild TEAE']","['Desidustat Treatment', 'placebo']","['responder rate', 'death or serious adverse event', 'safety, tolerability, and efficacy', 'pharmacokinetic parameters Cmax and AUC', 'vital signs, electrocardiographic parameters, or safety laboratory values', 'change in hemoglobin (Hb']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0518766'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",117.0,0.388018,"No death or serious adverse event was reported during the trial.
","[{'ForeName': 'Deven V', 'Initials': 'DV', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai, United Arab Emirates.'}, {'ForeName': 'Kevinkumar A', 'Initials': 'KA', 'LastName': 'Kansagra', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India, kevinkumarkansagra@zyduscadila.com.'}, {'ForeName': 'Jatin C', 'Initials': 'JC', 'LastName': 'Patel', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Shuchi N', 'Initials': 'SN', 'LastName': 'Joshi', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Nitin S', 'Initials': 'NS', 'LastName': 'Sharma', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Apeksha D', 'Initials': 'AD', 'LastName': 'Shelat', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Nirav B', 'Initials': 'NB', 'LastName': 'Patel', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Vishal B', 'Initials': 'VB', 'LastName': 'Nakrani', 'Affiliation': 'Zydus Research Centre, Clinical R&D, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': 'Farheen A', 'Initials': 'FA', 'LastName': 'Shaikh', 'Affiliation': 'Zydus Discovery DMCC, Dubai, United Arab Emirates.'}, {'ForeName': 'Harilal V', 'Initials': 'HV', 'LastName': 'Patel', 'Affiliation': 'Drug Metabolism and Pharmacokinetic, Cadila Healthcare Ltd., Ahmedabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000500232']
2930,31099803,Intracranial Tumors: A Nurse-Led Intervention for Educating and Supporting Patients and Their Caregivers,"BACKGROUND


Behavioral symptoms among postoperative patients with intracranial tumors and distress among caregivers are common.
OBJECTIVES


This article aimed to assess the effectiveness of a brief nurse-led intervention on behavioral symptoms of postoperative patients with intracranial tumors and distress of their caregivers.
METHODS


A randomized controlled trial was conducted on 80 patients with intracranial tumors and their family caregivers in a tertiary care institute in India. A brief nurse-led intervention was provided in the form of individual counseling, and a pamphlet was given to patients and caregivers in the experimental group at the time of discharge. Behavioral symptoms of patients and distress of caregivers were assessed.
FINDINGS


Patients in the experimental group had significantly fewer behavioral symptoms and less severity of behavioral symptoms as compared to the control group. Caregivers in the experimental group had significantly less severity of distress as compared to the control group.",2019,"FINDINGS


Patients in the experimental group had significantly fewer behavioral symptoms and less severity of behavioral symptoms as compared to the control group.","['postoperative patients with intracranial tumors and distress of their caregivers', 'Intracranial Tumors', '80 patients with intracranial tumors and their family caregivers in a tertiary care institute in India', 'postoperative patients with intracranial tumors and distress among caregivers are common']",['brief nurse-led intervention'],"['severity of distress', 'Behavioral symptoms', 'behavioral symptoms', 'severity of behavioral symptoms']","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1527390', 'cui_str': 'Neoplasms, Intracranial'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",80.0,0.039821,"FINDINGS


Patients in the experimental group had significantly fewer behavioral symptoms and less severity of behavioral symptoms as compared to the control group.","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Thakur', 'Affiliation': 'National Institute of Nursing Education.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Dhandapani', 'Affiliation': 'National Institute of Nursing Education.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Ghai', 'Affiliation': 'National Institute of Nursing Education.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Mohanty', 'Affiliation': 'Postgraduate Institute of Medical Education and Research.'}, {'ForeName': 'Sivashanmugam', 'Initials': 'S', 'LastName': 'Dhandapani', 'Affiliation': 'Postgraduate Institute of Medical Education and Research.'}]",Clinical journal of oncology nursing,['10.1188/19.CJON.315-323']
2931,32063251,Auditory brainstem response (ABR) profiling in schizoaffective disorder.,"OBJECTIVE


The aim of the study was to assess whether the auditory brainstem response (ABR) profiling test for schizophrenia (SZ) would recognise schizoaffective disorder (SZA) patients as SZ or not.
METHOD


Male and female SZA patients (n = 16) from the psychosis unit at Uppsala University Hospital were investigated. Coded sets of randomised ABR recordings intermingled with patients with SZ, adult attention-deficit hyperactivity disorder (ADHD) and healthy controls were analysed by an independent party blinded to clinical diagnoses.
RESULTS


The ABR profiling test for SZ was positive in 5/16 patients (31%) and negative in 11/16 patients (69%) with SZA. A surprising finding was that 4/16 (25%) SZA patients were positive for the ABR profiling test for ADHD.
CONCLUSION


With the ABR profiling test, a minority of patients with SZA tested positive for SZ. In contrast, a majority (85%) of patients with SZ in a previous study tested positive. These preliminary results leave us ignorant whether SZA should be regarded as a SZ-like disorder or a psychotic mood disorder and add to the questions regarding the validity of this diagnostic entity. However, the ABR profiling method is still in its infancy and its exploration in a range of psychiatric disorders is warranted.",2020,The ABR profiling test for schizophrenia was positive in 5/16 patients (31%) and negative in 11/16 patients (69%) with schizoaffective disorder.,"['patients with schizoaffective disorder tested positive for schizophrenia', 'schizophrenia would recognize schizoaffective disorder patients as schizophrenia or not', 'Male and female schizoaffective disorder patients (n=16) from the psychosis unit at Uppsala University Hospital were investigated', 'patients with schizophrenia, adult attention-deficit hyperactivity disorder (ADHD) and healthy controls']","['ABR profiling test', 'auditory brainstem response (ABR) profiling test']",['Auditory Brainstem Response (ABR'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085854', 'cui_str': 'Auditory Brainstem Responses'}]","[{'cui': 'C0085854', 'cui_str': 'Auditory Brainstem Responses'}]",,0.0718575,The ABR profiling test for schizophrenia was positive in 5/16 patients (31%) and negative in 11/16 patients (69%) with schizoaffective disorder.,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Juselius Baghdassarian', 'Affiliation': 'Department of Neuroscience, Psychiatry and Uppsala University Hospital, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Lewander', 'Affiliation': 'Department of Neuroscience, Psychiatry and Uppsala University Hospital, Uppsala University, Uppsala, Sweden.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.7']
2932,30623408,"Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial.","BACKGROUND


Transient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD). The treatment effect of TRPV1 antagonist via topical application in patients with AD remains unknown.
OBJECTIVES


To assess the clinical efficacy and safety of PAC-14028, a TRPV1 antagonist, via topical application in patients with AD.
METHODS


In this 8-week, phase IIb, randomized, double-blind, multicentre, vehicle-controlled study, patients with mild-to-moderate AD were randomized to receive PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream twice daily. The primary efficacy end point was the Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score of 0 or 1 at week 8. The secondary efficacy end points included the severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) 75/90.
RESULTS


A total of 194 patients were enrolled. IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (P = 0·0025 vs. vehicle), 38·30% for PAC-14028 cream 0·3% (P = 0·0087 vs. vehicle) and 57·45% for PAC-14028 cream 1·0% (P < 0·001 vs. vehicle). In particular, statistically significant differences were found between the vehicle and treatment groups in the IGA success rates with two-grade improvement. The SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale showed a trend towards improvement. No significant safety issues were reported.
CONCLUSIONS


PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD.",2019,"IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (","['patients with AD remains unknown', 'patients with mild-to-moderate atopic dermatitis', 'atopic dermatitis (AD', '194 patients were enrolled', 'patients with mild-to-moderate AD', 'patients with AD']","['PAC-14028, a TRPV1 antagonist', 'TRPV1 antagonist via topical application', 'PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist', 'PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream', 'PAC-14028 cream']","['severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index', 'effective and safe treatment modality', 'IGA success rates', 'SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale', ""Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score"", 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C3177712', 'cui_str': 'PAC-14028'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",194.0,0.135762,"IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (","[{'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Won', 'Affiliation': 'Department of Dermatology, Ulsan University College of Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Choi', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}]",The British journal of dermatology,['10.1111/bjd.17455']
2933,31087729,"A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities.","Multicenter, phase-4, randomized, comparative-efficacy study in patients with VLUs or DFUs comparing for noninferiority the percentage change in target ulcer dimensions (area, depth, and volume) a single-use negative pressure wound therapy (s-NPWT) system versus traditional NPWT (t-NPWT) over a 12-week treatment period or up to confirmed healing. Baseline values were taken at the randomization visit. Randomized by wound type and size, 164 patients with non-infected DFUs and VLUs were included. The ITT population was composed of 161 patients (101 with VLUs, 60 with DFUs) and 115 patients completed follow-up (64 in the s-NPWT group and 51 in the t-NPWT group) (PP population). The average age for all patients was 61.5 years, 36.6% were women, and treatment groups were statistically similar at baseline. Primary endpoint analyses on wound area reduction demonstrated statistically significant reduction in favor of s-NPWT (p = 0.003) for the PP population and for the ITT population (p < 0.001). Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT. Faster wound closure was observed with s-NPWT (Cox Proportional Hazards ratio (0.493 (0.273, 0.891); p = 0.019) in the ITT population. Wound closure occurred in 45% of patients in the s-NPWT group vs. 22.2% of patients in the t-NPWT group (p = 0.002). Median estimate of the time to wound closure was 77 days for s-NPWT. No estimate could be provided for t-NPWT due to the low number of patients achieving wound closure. Device-related AEs were more frequent in the t-NPWT group (41 AEs from 29 patients) than in the s-NPWT group (16 AEs from 12 patients). The s-NPWT system met noninferiority and achieved statistical superiority vs. t-NPWT in terms of wound progression toward healing over the treatment period. When NPWT is being considered for the management of challenging VLUs and DFUs, s-NPWT should be considered a first choice over other types of NPWT.",2019,Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT.,"['patients with VLUs or DFUs', 'chronic ulcers of the lower extremities', '164 patients with non-infected DFUs and VLUs were included', '161 patients (101 with VLUs, 60 with DFUs) and 115 patients completed follow-up (64 in the s-NPWT group and 51 in the t-NPWT group) (PP population']","['single-use negative pressure wound therapy system', 'traditional negative pressure wound therapy', 'single-use negative pressure wound therapy (s-NPWT) system versus traditional NPWT (t-NPWT']","['favor of s-NPWT', 'Changes in wound depth', 'Median estimate of the time to wound closure', 'Faster wound closure', 'Wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333297', 'cui_str': 'Chronic ulcer (morphologic abnormality)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0521118', 'cui_str': 'Non-infected (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}]",164.0,0.0349494,Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kirsner', 'Affiliation': 'Chairman and Harvey Blank Professor, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Cyaandi', 'Initials': 'C', 'LastName': 'Dove', 'Affiliation': 'Advanced Foot & Ankle Center, Las Vegas, NV.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Reyzelman', 'Affiliation': 'Associate Professor, Department of Medicine, California School of Podiatric Medicine at Samuel Merritt University, Co-Director UCSF Center for Limb Preservation, San Francisco, CA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Vayser', 'Affiliation': 'Scripps Clinic Medical Group, Department of Orthopedics/Foot & Ankle Center, Chief, Wound Care Division, San Diego, CA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Jaimes', 'Affiliation': 'Global Senior Medical Director-Wounds Smith and Nephew, London, UK.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12727']
2934,31320747,A head-to-head evaluation of the diagnostic efficacy and costs of trio versus singleton exome sequencing analysis.,"Diagnostic exome sequencing (ES) can be performed on the proband only (singleton; sES) or with additional samples, often including both biological parents with the proband (trio; tES). In this study we sought to compare the efficiencies of exome sequencing (ES) by trio (tES) versus singleton (sES) approach, determine costs, and identify factors to consider when deciding on optimal implementation strategies for the diagnosis of monogenic disorders. We undertook ES in 30 trios and analysed each proband's sES and tES data in parallel. Two teams were randomly allocated to either sES or tES analysis for each case and blinded to each other's work. Each task was timed and cost analyses were based on time taken and diagnostic yield. We modelled three scenarios to determine the factors to consider in the implementation of tES. sES diagnosed 11/30 (36.7%) cases and tES identified one additional diagnosis (12/30 (40.0%)). tES obviated the need for Sanger segregation, reduced the number of variants for curation, and had lower cost-per-diagnosis when considering analysis alone. When sequencing costs were included, tES nearly doubled the cost of sES. Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line. This approach requires a large differential in diagnostic yield between sES and tES for maximal benefit given current sequencing costs. tES may be preferable when scaling up laboratory throughput due to efficiency gains and opportunity cost considerations. Our findings are relevant to clinicians, laboratories and health services considering tES over sES.",2019,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[""30 trios and analysed each proband's sES and tES data in parallel""]","['exome sequencing (ES) by trio (tES) versus singleton (sES) approach', 'Diagnostic exome sequencing (ES', 'sES or tES']",[],"[{'cui': 'C0702111', 'cui_str': 'Proband (finding)'}]","[{'cui': 'C3178814', 'cui_str': 'Exome'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",[],,0.0342913,Reflexing to tES in those who remain undiagnosed after sES was cost-saving over tES in all as first-line.,"[{'ForeName': 'Tiong Yang', 'Initials': 'TY', 'LastName': 'Tan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. tiong.tan@vcgs.org.au.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lunke', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Chong', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Phelan', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Fanjul-Fernandez', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Justine E', 'Initials': 'JE', 'LastName': 'Marum', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Vanessa Siva', 'Initials': 'VS', 'LastName': 'Kumar', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Zornitza', 'Initials': 'Z', 'LastName': 'Stark', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Natasha J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stutterd', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sadedin', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martyn', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Thorne', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Gaff', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'White', 'Affiliation': 'Victorian Clinical Genetics Services, Melbourne, Australia. sue.white@vcgs.org.au.'}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0471-9']
2935,32039870,Effect of motor imagery combined with physical practice on upper limb rehabilitation in children with hemiplegic cerebral palsy.,"INTRODUCTION


Evidence indicates that motor deficits in hemiplegic cerebral palsy (HCP) impair both motor execution and planning. However, current rehabilitation efforts focus mainly on relieving impairments in motor execution. Motor imagery (MI) is a promising method for stimulating neural networks underlying the planning and control of movements.
OBJECTIVE


Evaluate the effectiveness of MI combined with physical practice in improving the function of the upper limbs in children with HCP.
METHOD


Twenty-four participants, aged 7-14 years were divided into two groups: intervention group (IG) and control group (CG). The IG was subjected to MI training and physical practice twice a week for eight consecutive weeks, while the CG received conventional therapy. Participants were assessed with the Assisting Hand Assessment (AHA) at pre-intervention, post-intervention, and follow up.
RESULTS


The results showed improved motor functions in both groups. Analysis using the general linear model (analysis of covariance) and Bonferroni post hoc tests showed significant improvements from pre-intervention to post-intervention in the AHA for the IG. The CG showed non-significant improvement in AHA scores.
CONCLUSIONS


These findings suggest that the MI training, combined with the physical practice program used in this study, was effective in improving upper limb function in children with HCP.",2020,Analysis using the general linear model (analysis of covariance) and Bonferroni post hoc tests showed significant improvements from pre-intervention to post-intervention in the AHA for the IG.,"['children with hemiplegic cerebral palsy', 'children with HCP', 'Twenty-four participants, aged 7-14 years', 'hemiplegic cerebral palsy (HCP']","['Motor imagery (MI', 'MI combined with physical practice', 'intervention group (IG) and control group (CG', 'motor imagery combined with physical practice']","['AHA scores', 'upper limb function', 'motor functions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",24.0,0.0134704,Analysis using the general linear model (analysis of covariance) and Bonferroni post hoc tests showed significant improvements from pre-intervention to post-intervention in the AHA for the IG.,"[{'ForeName': 'Deisiane Oliveira', 'Initials': 'DO', 'LastName': 'Souto', 'Affiliation': 'Graduate Program in Neurosciences, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Thalita Karla Flores', 'Initials': 'TKF', 'LastName': 'Cruz', 'Affiliation': 'Graduate Program in Neurosciences, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Kênia', 'Initials': 'K', 'LastName': 'Coutinho', 'Affiliation': 'Department of Psychology, Developmental Neuropsychology Laboratory, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Julio-Costa', 'Affiliation': 'Department of Psychology, Developmental Neuropsychology Laboratory, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Patrícia Lemos Buenos', 'Initials': 'PLB', 'LastName': 'Fontes', 'Affiliation': 'Department of Physiotherapy, Pontifícia Universidade Católica de Minas Gerais, Betim, Brazil.'}, {'ForeName': 'Vitor Geraldi', 'Initials': 'VG', 'LastName': 'Haase', 'Affiliation': 'Graduate Program in Neurosciences, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}]",NeuroRehabilitation,['10.3233/NRE-192931']
2936,31540863,"Impact of a Behavioral Intervention on Diet, Eating Patterns, Self-Efficacy, and Social Support.","OBJECTIVE


To examine the effectiveness of a structured multimodal behavioral intervention to change dietary behaviors, as well as self-efficacy and social support for engaging in healthier diets.
METHODS


A quasi-experimental design was used to assign sites into intervention and comparison groups. Data were collected at baseline, 3 months, and 6 months. The intervention group participated in Texercise Select, a 12-week lifestyle enhancement program. Multiple mixed-effects models were used to examine nutrition-related changes over time.
RESULTS


For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months. The magnitude of these improvements was significantly greater than changes in the comparison group.
CONCLUSIONS AND IMPLICATIONS


Findings suggest the intervention's ability to improve diet-related outcomes among older adults; however, additional efforts are needed to maintain changes over longer periods.",2020,"For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months.",['older adults'],"['structured multimodal behavioral intervention', 'Texercise Select, a 12-week lifestyle enhancement program', 'Behavioral Intervention']","['fast food consumption', 'water consumption', 'Diet, Eating Patterns, Self-Efficacy, and Social Support', 'fruit/vegetable consumption', 'social support']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0112083,"For the intervention group, significant improvements were observed for fast food consumption (P = .011), fruit/vegetable consumption (P = .008), water consumption (P = .009), and social support (P < .001) from baseline to 3 months.","[{'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Department of Health Promotion and Behavior, College of Public Health, The University of Georgia, Athens, GA. Electronic address: matthew.smith@tamu.edu.'}, {'ForeName': 'Shinduk', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Towne', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Department of Health Management & Informatics, University of Central Florida, Orlando, FL; Aging & Technology Faculty Cluster Initiative, University of Central Florida, Orlando, FL.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Department of Epidemiology & Biostatistics, School of Public Health, Texas A&M University, College Station, TX.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX.'}, {'ForeName': 'Ninfa C', 'Initials': 'NC', 'LastName': 'Peña-Purcell', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX; Family and Community Health, AgriLife Extension Service, Texas A&M University, College Station, TX.'}, {'ForeName': 'Marcia G', 'Initials': 'MG', 'LastName': 'Ory', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, TX; Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.008']
2937,29703749,Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit +  Cardiac Stem Cells As Regenerative Therapy for Heart Failure).,"RATIONALE


Autologous bone marrow mesenchymal stem cells (MSCs) and c-kit +  cardiac progenitor cells (CPCs) are 2 promising cell types being evaluated for patients with heart failure (HF) secondary to ischemic cardiomyopathy. No information is available in humans about the relative efficacy of MSCs and CPCs and whether their combination is more efficacious than either cell type alone.
OBJECTIVE


CONCERT-HF (Combination of Mesenchymal and c-kit +  Cardiac Stem Cells As Regenerative Therapy for Heart Failure) is a phase II trial aimed at elucidating these issues by assessing the feasibility, safety, and efficacy of transendocardial administration of autologous MSCs and CPCs, alone and in combination, in patients with HF caused by chronic ischemic cardiomyopathy (coronary artery disease and old myocardial infarction).
METHODS AND RESULTS


Using a randomized, double-blinded, placebo-controlled, multicenter, multitreatment, and adaptive design, CONCERT-HF examines whether administration of MSCs alone, CPCs alone, or MSCs+CPCs in this population alleviates left ventricular remodeling and dysfunction, reduces scar size, improves quality of life, or augments functional capacity. The 4-arm design enables comparisons of MSCs alone with CPCs alone and with their combination. CONCERT-HF consists of 162 patients, 18 in a safety lead-in phase (stage 1) and 144 in the main trial (stage 2). Stage 1 is complete, and stage 2 is currently randomizing patients from 7 centers across the United States.
CONCLUSIONS


CONCERT-HF will provide important insights into the potential therapeutic utility of MSCs and CPCs, given alone and in combination, for patients with HF secondary to ischemic cardiomyopathy.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02501811.",2018,"No information is available in humans about the relative efficacy of MSCs and CPCs and whether their combination is more efficacious than either cell type alone.
","['patients with heart failure (HF) secondary to ischemic cardiomyopathy', 'patients with HF caused by chronic ischemic cardiomyopathy (coronary artery disease and old myocardial infarction', '162 patients, 18 in a safety lead-in phase (stage 1) and 144 in the main trial (stage 2', 'Heart Failure', 'patients with HF secondary to ischemic cardiomyopathy']","['Autologous bone marrow mesenchymal stem cells (MSCs) and c-kit +  cardiac progenitor cells (CPCs', 'placebo', 'CONCERT-HF (Combination of Mesenchymal and c-kit +  Cardiac Stem Cells', 'MSCs alone with CPCs alone and with their combination', 'MSCs alone, CPCs alone, or MSCs+CPCs', 'Mesenchymal and c-kit +  Cardiac Stem Cells']","['scar size, improves quality of life, or augments functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",162.0,0.248845,"No information is available in humans about the relative efficacy of MSCs and CPCs and whether their combination is more efficacious than either cell type alone.
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bolli', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'March', 'Affiliation': 'Division of Cardiovascular Medicine, UFHealth at University of Florida, Gainesville (K.L.M., C.J.P.).'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, UFHealth at University of Florida, Gainesville (K.L.M., C.J.P.).'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Willerson', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).""}, {'ForeName': 'Emerson C', 'Initials': 'EC', 'LastName': 'Perin', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).""}, {'ForeName': 'Phillip C', 'Initials': 'PC', 'LastName': 'Yang', 'Affiliation': 'Cardiovascular Medicine, Stanford University School of Medicine, CA (P.C.Y.).'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.).'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MN (J.H.T.).'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Mitrani', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Hernandez-Schulman', 'Affiliation': 'Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, FL (J.M.H., A.K., R.D.M., I.H.-S.).'}, {'ForeName': 'Doris A', 'Initials': 'DA', 'LastName': 'Taylor', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health, Houston (J.T.W., E.C.P., D.A.T.).""}, {'ForeName': 'Darcy L', 'Initials': 'DL', 'LastName': 'DiFede', 'Affiliation': 'Biological Consulting, LLC, Miami, FL (D.L.D.).'}, {'ForeName': 'João A C', 'Initials': 'JAC', 'LastName': 'Lima', 'Affiliation': 'Division of Cardiology, Johns Hopkins University, Baltimore, MD (J.A.C.L.).'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chugh', 'Affiliation': 'Franciscan Saint Francis Health, Indianapolis, IN (A.C.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Loughran', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Louisville, KY (R.B., J.L.).'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Vojvodic', 'Affiliation': 'Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Sayre', 'Affiliation': 'Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bettencourt', 'Affiliation': 'Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.).'}, {'ForeName': 'Lem', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': 'Coordinating Center for Clinical Trials, UT Health School of Public Health, Houston, TX (R.W.V., S.L.S., J.B., M.C., L.M.) lemmoye@msn.com.'}, {'ForeName': 'Ray F', 'Initials': 'RF', 'LastName': 'Ebert', 'Affiliation': 'NIH, National Heart, Lung, and Blood Institute, Division of Cardiovascular Sciences, Bethesda, MD (R.F.E.).'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Simari', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation research,['10.1161/CIRCRESAHA.118.312978']
2938,31773201,Dexmedetomidine combined with interscalene brachial plexus block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair.,"PURPOSE


Interscalene brachial plexus block (ISB) is one of the most commonly used regional blocks in relieving postoperative pain after arthroscopic rotator cuff repair. Dexmedetomidine (DEX) is an alpha 2 agonist that can enhance the effect of regional blocks. The aim of this study was to compare the effects of DEX combined with ISB with ISB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 h after arthroscopic rotator cuff repair.
METHODS


Fifty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single center, double-blinded randomized controlled trial study. Twenty-five patients were randomly allocated to group 1 and received ultrasound-guided ISB using a mixture of 1 ml (100 μg) of DEX and 8 ml of 0.75% ropivacaine preemptively. The other 25 patients were allocated to group 2 and underwent ultrasound-guided ISB alone using a mixture of 1 ml of normal saline and 8 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h postoperatively. The plasma interleukin (IL)-6, -8, -1β, cortisol, and substance P levels were also measured within 48 h, postoperatively.
RESULTS


Group 1 showed a significantly lower mean VAS score and a significantly higher mean SAT score than group 2 at 1, 3, 6, 12, and 18 h postoperatively. Compared with group 2, group 1 showed a significantly lower mean plasma IL-6 level at 1, 6, 12, and 48 h postoperatively and a significantly lower mean IL-8 level at 1, 6, 12, 24, and 48 h postoperatively. The mean timing of rebound pain in group 1 was significantly later than that in group 2 (12.7 h > 9.4 h, p = 0.006).
CONCLUSIONS


Ultrasound-guided ISB with DEX in arthroscopic rotator cuff repair led to a significantly lower mean VAS score and a significantly higher mean SAT score within 48 h postoperatively than ISB alone. In addition, ISB with DEX showed lower mean plasma IL-6 and IL-8 levels than ISB alone within 48 h postoperatively, with delayed rebound pain.
LEVEL OF EVIDENCE


I.
TRIAL REGISTRATION


2013-112, ClinicalTrials.gov Identifier: NCT02766556.",2020,"RESULTS


Group 1 showed a significantly lower mean VAS score and a significantly higher mean SAT score than group 2 at 1, 3, 6, 12, and 18 h postoperatively.","['after arthroscopic rotator cuff repair', 'Twenty-five patients', '25 patients', 'Fifty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair', 'arthroscopic rotator cuff repair']","['ISB with ISB', 'interscalene brachial plexus block', 'ultrasound-guided ISB alone using a mixture of 1\xa0ml of normal saline and 8\xa0ml of ropivacaine', 'ISB with DEX', 'Dexmedetomidine', 'DEX and 8\xa0ml of 0.75% ropivacaine', 'Dexmedetomidine (DEX', 'ultrasound-guided ISB', 'Interscalene brachial plexus block (ISB', 'DEX']","['postoperative pain', 'mean SAT score', 'mean plasma IL-6 level', 'mean IL-8 level', 'mean timing of rebound pain', 'plasma interleukin (IL)-6, -8, -1β, cortisol, and substance P levels', 'mean plasma IL-6 and IL-8 levels', 'postoperative pain, satisfaction, and pain-related cytokines', 'visual analog scale (VAS) for pain and patient satisfaction (SAT) scores', 'mean VAS score']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0038585', 'cui_str': 'Euler-Gaddum Substance P'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}]",50.0,0.203257,"RESULTS


Group 1 showed a significantly lower mean VAS score and a significantly higher mean SAT score than group 2 at 1, 3, 6, 12, and 18 h postoperatively.","[{'ForeName': 'Jung-Taek', 'Initials': 'JT', 'LastName': 'Hwang', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Ji Su', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}, {'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea. t01031028171@gmail.com.'}, {'ForeName': 'Dong-Keun', 'Initials': 'DK', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Han Na', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Sang-Soo', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Sung Mi', 'Initials': 'SM', 'LastName': 'Hwang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}, {'ForeName': 'Yong-Been', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Sanghyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05799-3']
2939,31200321,Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma.,"BACKGROUND


The American Joint Committee on Cancer-8 (AJCC) classification of melanoma was implemented in January 2018. It was based on data gathered when checkpoint inhibitors were not used as adjuvant therapy in stage III melanoma. The European Organization for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 double-blind phase III trial evaluated pembrolizumab vs placebo in AJCC-7 stage IIIA (excluding lymph node metastasis ≤1 mm), IIIB or IIIC (without in-transit metastasis) patients after complete lymphadenectomy.
PATIENTS, METHODS AND RESULTS


Patients (n = 1019) were randomised 1:1 to pembrolizumab 200 mg or placebo every 3 weeks (total of 18 doses, ∼1 year). At 1.25-year median follow-up, pembrolizumab prolonged relapse-free survival (RFS) in the total population (1-year RFS rate: 75.4% vs 61.0%; hazard ratio [HR] 0.57; logrank P < 0.0001) and consistently in the AJCC-7 subgroups. Prognostic and predictive values of AJCC-8 for RFS were evaluated in this study. Patient distribution according to the AJCC-8 stage subgroups was 8% (IIIA), 34.7% (IIIB), 49.7% (IIIC), 3.7% (IIID) and 3.8% (unknown). AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68). The 1-year RFS rate for pembrolizumab vs placebo and the HRs (99% confidence interval) within each AJCC-8 subgroup were as follows: stage IIIA (92.7% vs 92.5%; 0.76 [0.11-5.43]), IIIB (79.0% vs 65.5%; 0.59 [0.35-0.99]), IIIC (73.6% vs 53.9%; 0.48 [0.33-0.70]) and IIID (50.0% vs 33.3%; 0.69 [0.24-2.00]).
CONCLUSIONS


AJCC-8 staging had a strong prognostic importance for RFS but no predictive importance: the RFS benefit of pembrolizumab was observed across AJCC-8 subgroups in resected high-risk stage III melanoma patients.",2019,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","['Cancer (EORTC', 'Patients (n\xa0', 'AJCC-7 stage', '1019', 'resected high-risk stage III melanoma']","['pembrolizumab vs placebo', 'pembrolizumab 200\xa0mg or placebo']","['pembrolizumab prolonged relapse-free survival (RFS', 'RFS (HRs for stage IIIB, IIIC\xa0and IIID vs IIIA', '1-year RFS rate']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1019.0,0.585471,"AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68).","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: alexander.eggermont@gustaveroussy.fr.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Lichinitser', 'Affiliation': 'Russian Oncology Scientific Centre, Moscow, Russia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital/University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Universitaetsklinikum - University Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus Jm', 'Initials': 'AJ', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, Location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lupinacci', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.020']
2940,31483155,Impact of acute antioxidant administration on inflammation and vascular function in heart failure with preserved ejection fraction.,"Although it is now well established that heart failure with preserved ejection fraction (HFpEF) is associated with marked inflammation and a prooxidant state that is accompanied by vascular dysfunction, whether acute antioxidant (AO) administration can effectively target these disease-related decrements has not been evaluated. Thus, the present study sought to evaluate the efficacy of an acute over-the-counter AO cocktail (600 mg α-lipoic acid, 1,000 mg vitamin C, and 600 IU vitamin E) to mitigate inflammation and oxidative stress, and subsequently improve nitric oxide (NO) bioavailability and vascular function, in patients with HFpEF. Flow-mediated dilation (FMD) and reactive hyperemia (RH) were evaluated to assess conduit vessel and microvascular function, respectively, 90 min after administration of either placebo (PL) or AO in 16 patients with HFpEF (73 ± 10 yr, EF 54-70%) using a double-blind, crossover design. Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (malondialdehyde and protein carbonyl), free radical concentration (EPR spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, [Formula: see text], and nitrite, [Formula: see text]) were also assessed. FMD improved following AO administration (PL: 3.49 ± 0.7%, AO: 5.83 ± 1.0%), whereas RH responses were similar between conditions (PL: 428 ± 51 mL, AO: 425 ± 51 mL). AO administration decreased CRP (PL: 4,429 ± 705 ng/mL, AO: 3,664 ± 520 ng/mL) and increased ascorbate (PL: 30.0 ± 2.9 µg/mL, AO: 45.1 ± 3.7 µg/mL) and [Formula: see text] (PL: 182 ± 21 nM, AO: 213 ± 24 nM) but did not affect other biomarkers. Together, these data suggest that acute AO administration can exert anti-inflammatory effects and improve conduit artery vasodilation, but not microvascular function, in patients with HFpEF.",2019,"Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ) were also assessed.
","['Heart Failure with Preserved Ejection Fraction', '16 patients with HFpEF', 'patients with HFpEF']","['Acute Antioxidant Administration', 'counter AO cocktail (600mg alpha lipoic acid, 1,000mg Vitamin C, and 600IU vitamin E', 'placebo (PL']","['RH responses', 'nitric oxide (NO) bioavailability and vascular function', 'Inflammation and Vascular Function', 'Flow mediated dilation (FMD) and reactive hyperemia (RH', 'Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ', 'FMD', 'conduit artery vasodilation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0678420', 'cui_str': 'Alcoholic mixed drink'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0016693', 'cui_str': 'Free Radicals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0441247', 'cui_str': 'Conduit (physical object)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}]",,0.237953,"Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ) were also assessed.
","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Clifton', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Jayson R', 'Initials': 'JR', 'LastName': 'Gifford', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'LaSalle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Taylor S', 'Initials': 'TS', 'LastName': 'Thurston', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Alpenglow', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Josephine B', 'Initials': 'JB', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00184.2019']
2941,31097441,"Comparison of changes in corneal endothelial cell density and central corneal thickness between conventional and femtosecond laser-assisted cataract surgery: a randomised, controlled clinical trial.","BACKGROUND/AIM


To identify changes in endothelial cell density (ECD) and central corneal thickness (CCT) in eyes undergoing femtosecond laser-assisted cataract surgery (FLACS) compared with conventional phacoemulsification surgery (CPS).
METHODS


This is an intraindividual randomised, controlled clinical trial. One eye was randomised to receive FLACS, while the contralateral eye of the same patient received CPS. The femtosecond laser pretreatment included creating main and side-port corneal incisions, capsulotomy and lens fragmentation. Non-contact endothelial cell microscopy and pachymetry were performed preoperatively and at postoperative day 1, week 1, month 1 and month 3.
RESULTS


A total of 134 paired eyes from 67 patients were included in the analysis. ECD was not significantly different between the two groups at either postoperative month 1 (2370±580 cells/mm 2  and 2467±564 cells/mm 2  in FLACS and CPS groups, respectively; p=0.18) or at postoperative month 3 (2374±527 cells/mm 2  and 2433±526 cells/mm 2  in FLACS and CPS groups, respectively; p=0.19). No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
CONCLUSION


Postoperative corneal ECD and CCT were comparable between FLACS and CPS during the 3 months' follow-up period.",2020,"No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
","['A total of 134 paired eyes from 67 patients were included in the analysis', 'eyes undergoing']","['CPS', 'femtosecond laser-assisted cataract surgery (FLACS', 'conventional and femtosecond laser-assisted cataract surgery', 'conventional phacoemulsification surgery (CPS', 'FLACS and CPS', 'femtosecond laser pretreatment included creating main and side-port corneal incisions, capsulotomy and lens fragmentation', 'FLACS']","['mean CCT values', 'corneal endothelial cell density and central corneal thickness', 'endothelial cell density (ECD) and central corneal thickness (CCT', 'ECD']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}]",67.0,0.0917905,"No significant difference was observed in the mean CCT values between the two groups over the follow-up period (p>0.05).
","[{'ForeName': 'Daliya', 'Initials': 'D', 'LastName': 'Dzhaber', 'Affiliation': 'Cornea, Cataract and External Diseases, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Mustafa', 'Affiliation': 'Wilmer Eye institute, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Alsaleh', 'Affiliation': 'Ophthalmology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mihailovic', 'Affiliation': 'Glaucoma, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Yassine J', 'Initials': 'YJ', 'LastName': 'Daoud', 'Affiliation': 'Wilmer Eye institute, Johns Hopkins University, Baltimore, Maryland, USA ydaoud1@jhmi.edu.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313723']
2942,31968307,The Acute Effect of Mental Fatigue on Badminton Performance in Elite Players.,"PURPOSE


Several studies have examined the effect of MF on sport performance, but no studies have been conducted on badminton performance. The purpose of the present study was to examine the acute effect of mental fatigue (MF) on badminton performance in elite players.
METHODS


In total, 19 elite Danish badminton players completed 2 test days in randomized order, separated by 48 h. On day 1, to elicit MF, a 60-min incongruent Stroop task was performed. On day 2, 60 min of an emotionally neutral documentary was used for the control condition. After either condition, subjects performed a badminton-specific test (BST) where performance time was measured, as well as countermovement-jump height, heart rate, rating of perceived exertion, and lactate. Psychological questionnaires were answered under both conditions.
RESULTS


Subjects were significantly more mentally fatigued (P = .002) after the Stroop intervention than in the control. No differences between conditions were detected in the BST (control 32.43 [1.96] vs MF 32.43 [2.36] s; P = .99, Student t test). In addition, no effect of condition (P = .64), time (P = .14), or condition × time (P = .87) was found (2-way analysis of variance). Furthermore, no differences in heart rate, countermovement jump, or rating of perceived exertion were observed between conditions. Lactate showed no effect of condition (P = .46).
CONCLUSION


Despite being more mentally fatigued after the Stroop test than in the control condition, performance was not negatively affected during a BST. In addition, no differences in physiological measures were observed.",2020,"Furthermore, no differences in heart rate, countermovement jump, or rating of perceived exertion were observed between conditions.","['Elite Players', '19 elite Danish badminton players', 'elite players']","['mental fatigue (MF', 'MF']","['physiological measures', 'mentally fatigued', 'countermovement-jump height, heart rate, rating of perceived exertion, and lactate', 'Psychological questionnaires', 'heart rate, countermovement jump, or rating of perceived exertion', 'BST']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}]","[{'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",19.0,0.0392525,"Furthermore, no differences in heart rate, countermovement jump, or rating of perceived exertion were observed between conditions.","[{'ForeName': 'Mathias H', 'Initials': 'MH', 'LastName': 'Kosack', 'Affiliation': ''}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Staiano', 'Affiliation': ''}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Folino', 'Affiliation': ''}, {'ForeName': 'Mads B', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lønbro', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0361']
2943,32007295,Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVE


To investigate whether a dose-response relationship exists between volume of exercise and discontinuation of glucose-lowering medication treatment in patients with type 2 diabetes.
PATIENTS AND METHODS


Secondary analyses of a randomized controlled exercise-based lifestyle intervention trial (April 29, 2015 to August 17, 2016). Patients with non-insulin-dependent type 2 diabetes were randomly assigned to an intensive lifestyle intervention (U-TURN) or standard-care group. Both groups received lifestyle advice and objective target-driven medical regulation. Additionally, the U-TURN group received supervised exercise and individualized dietary counseling. Of the 98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31). Participants in the U-TURN group were stratified into tertiles based on accumulated volumes of exercise completed during the 1-year intervention.
RESULTS


Median exercise levels of 178 (interquartile range [IQR], 121-213; lower tertile), 296 (IQR, 261-310; intermediate tertile), and 380 minutes per week (IQR, 355-446; upper tertile) were associated with higher odds of discontinuing treatment with glucose-lowering medication, with corresponding odds ratios of 12.1 (95% CI, 1.2-119; number needed to treat: 4), 30.2 (95% CI, 2.9-318.5; 3), and 34.4 (95% CI, 4.1-290.1; 2), respectively, when comparing with standard care. Cardiovascular risk factors such as glycated hemoglobin A 1c  levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group.
CONCLUSION


Exercise volume is associated with discontinuation of glucose-lowering medication treatment in a dose-dependent manner, as are important cardiovascular risk factors in well-treated participants with type 2 diabetes and disease duration less than 10 years. Further studies are needed to support these findings.
STUDY REGISTRATION


ClinicalTrials.gov registration (NCT02417012).",2020,"Cardiovascular risk factors such as glycated hemoglobin A 1c  levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group.
","['trial (April 29, 2015 to August 17, 2016', 'Patients with non-insulin-dependent type 2 diabetes', '98 randomly assigned participants, 92 were included in the analysis (U-TURN, n=61, standard care, n=31', 'Type 2 Diabetes', 'patients with type 2 diabetes']","['supervised exercise and individualized dietary counseling', 'intensive lifestyle intervention (U-TURN) or standard-care group', 'Exercise', 'glucose-lowering medication treatment', 'controlled exercise-based lifestyle intervention', 'lifestyle advice and objective target-driven medical regulation']","['Cardiovascular risk factors such as glycated hemoglobin A 1c  levels, fitness, 2-hour glucose levels, and triglyceride levels', 'Median exercise levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",98.0,0.0908662,"Cardiovascular risk factors such as glycated hemoglobin A 1c  levels, fitness, 2-hour glucose levels, and triglyceride levels were improved significantly in the intermediate and upper tertiles, but not the lower tertile, compared with the standard-care group.
","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'MacDonald', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; CopenRehab, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. Electronic address: chmd@sund.ku.dk.'}, {'ForeName': 'Mette Y', 'Initials': 'MY', 'LastName': 'Johansen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabrina M', 'Initials': 'SM', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Allan A', 'Initials': 'AA', 'LastName': 'Vaag', 'Affiliation': 'AstraZeneca, Early Clinical Development, Cardiovascular, Renal and Metabolic Research, Mölndal, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lieberman', 'Affiliation': 'Department of Human Evolutionary Biology, Harvard University, Cambridge, MA.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2019.09.005']
2944,30828929,Better glycaemic control with BioChaperone glargine lispro co-formulation than with insulin lispro Mix25 or separate glargine and lispro administrations after a test meal in people with type 2 diabetes.,"Because of its physico-chemical properties, insulin glargine is usually not mixable with rapid insulins. BioChaperone BC147 is a polyanionic amphiphilic polymer, solubilizing insulin glargine at neutral pH, and thus enabling stable glargine formulation with fast-acting insulin lispro (BioChaperone glargine lispro co-formulation [BC Combo]). We investigated pharmacokinetic (PK) endpoints and postprandial glucose (PPG) control after administration of BC Combo (75% insulin glargine, 25% insulin lispro), insulin lispro Mix25 (LMix) and separate injections of insulins glargine (75% total dose) and lispro (25% total dose [G + L]) immediately before ingestion of a mixed meal in people with type 2 diabetes mellitus (T2DM), using a randomized, double-blind, double-dummy crossover study design. Participants received individualized bolus doses (mean 0.62 U/kg) of BC Combo, LMix or G + L, together with a solid mixed meal (610 kcal, 50% carbohydrate, 30% fat, 20% protein). Insulin dosages were kept constant for each study day. Thirty-nine participants with T2DM (mean ± SD age and glycated haemoglobin 60.8 ± 7.5 years and  64 ± 6 mmol/mol, respectively) were randomized. BC Combo improved the predefined primary endpoint, early PPG control, compared to LMix (incremental area under the blood glucose concentration-time curve from 0 to 2 hours after the meal [ΔAUC BG,0-2h  ] reduction of 18%; P = 0.0009) and G + L (ΔAUC BG,0-2h  reduction of 10%; P = 0.0450). The number of mealtime hypoglycaemic episodes per participant was lower with BC Combo (22 episodes in 14 participants) compared to LMix (43 episodes in 20 participants; P = 0.0028), but not significantly different from G + L (28 episodes in 19 participants; P = 0.2523). BC Combo demonstrated superior early PPG control with fewer hypoglycaemic episodes compared to LMix and superior early PPG control compared to separate G + L administrations.",2019,BC Combo demonstrated superior early PPG control with fewer hypoglycaemic episodes compared to LMix and superior early PPG control compared to separate G + L administrations.,"['people with type 2 diabetes mellitus (T2DM', 'Thirty-nine participants with T2DM (mean\u2009±\u2009SD age and glycated haemoglobin 60.8\u2009±\u20097.5 years and \u200964 ±\u20096 mmol/mol, respectively) were randomized', 'people with type 2 diabetes']","['BC Combo, LMix or G\u2009+\u2009L, together with a solid mixed meal', 'lispro (25% total dose [G\u2009+\u2009L]) immediately before ingestion of a mixed meal', 'BioChaperone BC147', 'BC Combo (75% insulin glargine, 25% insulin lispro), insulin lispro Mix25 (LMix) and separate injections of insulins glargine', 'BioChaperone glargine lispro co-formulation']","['pharmacokinetic (PK) endpoints and postprandial glucose (PPG) control', 'number of mealtime hypoglycaemic episodes', 'LMix (incremental area under the blood glucose concentration-time curve']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",39.0,0.211295,BC Combo demonstrated superior early PPG control with fewer hypoglycaemic episodes compared to LMix and superior early PPG control compared to separate G + L administrations.,"[{'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Meiffren', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Herbrand', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Ernestos', 'Initials': 'E', 'LastName': 'Anastassiadis', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Klein', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Alluis', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mégret', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gaudier', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Soula', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13685']
2945,31868684,The Minimal Clinically Relevant Change of the FOG Score.,"BACKGROUND


Freezing of gait is a highly disabling symptom in persons with Parkinson's disease (PwP). Despite its episodic character, freezing can be reliably evaluated using the FOG score. The description of the minimal clinically relevant change is a requirement for a meaningful interpretation of its results.
OBJECTIVE


To determine the minimal clinically relevant change of the FOG score.
METHODS


We evaluated video recordings of a standardized freezing-evoking gait parkour, i.e., the FOG score just before and 30 minutes after the intake of a regular levodopa dose in a randomized blinded fashion. The minimal clinically relevant response was considered a value of one or more on a 7-step Likert-type response scale [-3; +3] that served as the anchor. The minimal clinically relevant change was determined by ROC analysis.
RESULTS


37 PwP (Hoehn & Yahr stages 2.5-4, 27 male, 10 female) were aged 68.2 years on average (range 45-80). Mean disease duration was 12.9 years (2-29 years). Minimum FOG score was 0 and Maximum FOG score was 29. Mean FOG scores before medication were 10.6, and 11.1 after medication intake, with changes ranging from -14.7 to +16.7. The minimal clinically relevant change (MCRC) for improvement based on expert clinician rating was three scale points with a sensitivity of 0.67 and a specificity of 0.96.
CONCLUSIONS


The FOG score is recognized as a useful clinical instrument for the evaluation of freezing in the clinical setting. Knowledge of the MCRC should help to define responses to interventions that are discernible and meaningful to the expert physician and to the patient.",2020,"Mean FOG scores before medication were 10.6, and 11.1 after medication intake, with changes ranging from -14.7 to +16.7.","['37 PwP (Hoehn & Yahr stages 2.5-4, 27 male, 10 female', 'were aged 68.2 years on average (range 45-80', ""persons with Parkinson's disease (PwP""]",[],"['FOG Score', 'Mean disease duration', 'Maximum FOG score', 'Minimum FOG score', 'Mean FOG scores']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]",[],"[{'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",27.0,0.0541969,"Mean FOG scores before medication were 10.6, and 11.1 after medication intake, with changes ranging from -14.7 to +16.7.","[{'ForeName': 'Urban M', 'Initials': 'UM', 'LastName': 'Fietzek', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, Schön Klinik München Schwabing, Munich, Germany.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Schulz', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, Schön Klinik München Schwabing, Munich, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, Schön Klinik München Schwabing, Munich, Germany.'}, {'ForeName': 'Andres O', 'Initials': 'AO', 'LastName': 'Ceballos-Baumann', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, Schön Klinik München Schwabing, Munich, Germany.'}]",Journal of Parkinson's disease,['10.3233/JPD-191783']
2946,30995657,Fruit and Vegetable Treatment of Chronic Kidney Disease-Related Metabolic Acidosis Reduces Cardiovascular Risk Better than Sodium Bicarbonate.,"BACKGROUND


Current guidelines recommend treatment of metabolic acidosis in chronic kidney disease (CKD) with sodium-based alkali. We tested the hypothesis that treatment with base-producing fruits and vegetables (F + V) better improves cardiovascular disease (CVD) risk indicators than oral sodium bicarbonate (NaHCO3).
METHODS


We randomized 108 macroalbuminuric, matched, nondiabetic CKD patients with metabolic acidosis to F + V (n = 36) in amounts to reduce dietary acid by half, oral NaHCO3 (HCO3, n = 36) 0.3 mEq/kg bw/day, or to Usual Care (UC, n = 36) to assess the 5-year effect of these interventions on estimated glomerular filtration rate (eGFR) course as the primary analysis and on indicators of CVD risk as the secondary analysis.
RESULTS


Five-year plasma total CO2 was higher in HCO3 and F + V than UC but was not different between HCO3 and F + V (difference p value < 0.01). Five-year net eGFR decrease was less in HCO3 (mean -12.3, 95% CI -12.9 to -11.7 mL/min/1.73 m2) and F + V (-10.0, 95% CI -10.6 to -9.4 mL/min/1.73 m2) than UC (-18.8, 95% CI -19.5 to -18.2 mL/min/1.73 m2; p value < 0.01) but was not different between HCO3 and F + V. Five-year systolic blood pressure was lower in F + V than UC and HCO3 (p value < 0.01). Despite similar baseline values, F + V had lower low-density lipoprotein, Lp(a), and higher serum vitamin K1 (low serum K1 is associated with coronary artery calcification) than HCO3 and UC at 5 years.
CONCLUSION


Metabolic acidosis improvement and eGFR preservation were comparable in CKD patients treated with F + V or oral NaHCO3 but F + V better improved CVD risk indicators, making it a potentially better treatment option for reducing CVD risk.",2019,"Five-year net eGFR decrease was less in HCO3 (mean -12.3, 95% CI -12.9 to -11.7",['nondiabetic CKD patients with metabolic acidosis to F + V (n = 36) in'],"['oral sodium bicarbonate (NaHCO3', 'Sodium Bicarbonate', 'base-producing fruits and vegetables (F + V', 'amounts to reduce dietary acid by half, oral NaHCO3 (HCO3, n = 36) 0.3 mEq/kg bw/day, or to Usual Care']","['plasma total CO2', 'CVD risk indicators', 'glomerular filtration rate (eGFR) course', 'systolic blood pressure', 'cardiovascular disease (CVD) risk indicators', 'Metabolic acidosis improvement and eGFR preservation', 'HCO3', 'low-density lipoprotein, Lp(a), and higher serum vitamin K1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}]",108.0,0.0830297,"Five-year net eGFR decrease was less in HCO3 (mean -12.3, 95% CI -12.9 to -11.7","[{'ForeName': 'Nimrit', 'Initials': 'N', 'LastName': 'Goraya', 'Affiliation': 'Departments of Internal Medicine, Texas A&M College of Medicine, Temple, Texas, USA.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Munoz-Maldonado', 'Affiliation': 'Statistical Savvy Consulting, Georgetown, Texas, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Department of Internal Medicine, Texas A&M Health Sciences Center College of Medicine, Dallas, Texas, USA, Donald.wesson@BSWHealth.org.'}]",American journal of nephrology,['10.1159/000500042']
2947,31325040,Daily intake of wheat germ-enriched bread may promote a healthy gut bacterial microbiota: a randomised controlled trial.,"PURPOSE


Wheat bran fibre has a beneficial effect on gastrointestinal function, but evidence for wheat germ is scarce. Accordingly, we evaluated the effects of daily intake of wheat germ on gastrointestinal discomfort and gut microbiota by adding wheat germ to refined (white) wheat bread, the most consumed bread type. We hypothesised that an improvement in the composition of refined bread could beneficially affect intestinal health without compromising consumers' acceptance.
METHODS


Fifty-five healthy adults were recruited for a randomised, double-blind, crossover, controlled trial comprising two 4-week intervention periods separated by a 5-week washout stage. During the first 4-week period, one group consumed wheat bread enriched with 6 g of wheat germ and the control group consumed non-enriched wheat bread.
RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm. Importantly, intake of wheat germ-enriched bread decreased the perceived gastrointestinal discomfort-related quality of life (subscale worries and concerns) over refined white bread. The improvements in the gastrointestinal function were accompanied by favourable changes in gut microbiota, increasing the number of Bacteroides spp. and Bifidobacterium spp.
CONCLUSIONS


Adding wheat germ to industrially made white bread without altering sensory properties may promote a healthy gut bacterial microbiota and the gastrointestinal health.",2020,"RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm.","['healthy gut bacterial microbiota', 'Fifty-five healthy adults']","['wheat bread enriched with 6\xa0g of wheat germ and the control group consumed non-enriched wheat bread', 'Daily intake of wheat germ-enriched bread']","['gastrointestinal discomfort and gut microbiota', 'gastrointestinal discomfort-related quality of life (subscale worries and concerns', 'number of Bacteroides spp', 'gastrointestinal function', 'minimal gastrointestinal improvements']","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",55.0,0.0922088,"RESULTS


Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm.","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Moreira-Rosário', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal. andrerosario@med.up.pt.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Marques', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Pinheiro', 'Affiliation': 'Nutrition and Metabolism, NOVA Medical School, NOVA University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Norberto', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sintra', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'José António', 'Initials': 'JA', 'LastName': 'Teixeira', 'Affiliation': 'Center of Biological Engineering, University of Minho, Campus of Gualtar, Braga, Portugal.'}, {'ForeName': 'Conceição', 'Initials': 'C', 'LastName': 'Calhau', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Luís Filipe', 'Initials': 'LF', 'LastName': 'Azevedo', 'Affiliation': 'Centre for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}]",European journal of nutrition,['10.1007/s00394-019-02045-x']
2948,30649492,Experimental Pain Is Alleviated by Manual Traction Itself Rather than Subjective Bias in the Knee: A Signal Detection Analysis.,"BACKGROUND


Manual traction is used for pain relief, but it is not clear whether the pain relief effect of manual traction is due to sensitivity or to subjective bias. The differences between manual traction and touch have also been unclear.
OBJECTIVES


We used signal detection theory to investigate whether manual traction and touch were effective for pain relief, and we compared the pain relief effect between manual traction and touch.
DESIGN


Repeated measures and single blinding.
METHODS


Twenty healthy adult volunteers performed an intensity judgment task immediately before and after each intervention. The intervention was either manual traction or touch for 10 minutes. We measured the intensity judgment task's signal detection measures of hit rates, false alarm rates, sensitivity (d'), and response bias (C) in an Aδ fiber-mediated pain condition and C fiber-mediated pain condition.
RESULTS


Manual traction did not provide a significant level of change, but its effect sizes differed. In our comparison of the effect sizes, manual traction tended to reduce the hit rate and altered the sensitivity value rather than the response bias in Aδ fiber-mediated pain. There was no significant difference in the amount of change in the hit rate between touch and manual traction regarding Aδ fiber-mediated pain and C fiber-mediated pain.
CONCLUSIONS


In terms of effect sizes, manual traction was effective for the pain relief of the first pain by producing a change in pain sensitivity rather than by subjective bias. Manual traction reduced the first pain, whereas touch reduced the first pain and second pain.",2019,"There was no significant difference in the amount of change in the hit rate between touch and manual traction regarding Aδ fiber-mediated pain and C fiber-mediated pain.
","['Twenty healthy adult volunteers', 'Knee']","['Manual traction', 'manual traction or touch for 10\u2009minutes']","['first pain and second pain', 'hit rate between touch and manual traction regarding Aδ fiber-mediated pain and C fiber-mediated pain', 'pain relief effect', ""intensity judgment task's signal detection measures of hit rates, false alarm rates, sensitivity (d'), and response bias (C) in an Aδ fiber-mediated pain condition and C fiber-mediated pain condition""]","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0006549', 'cui_str': 'C Fibers'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection Analysis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",20.0,0.0287478,"There was no significant difference in the amount of change in the hit rate between touch and manual traction regarding Aδ fiber-mediated pain and C fiber-mediated pain.
","[{'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Shigetoh', 'Affiliation': 'Department of Neurorehabilitation, Graduate School of Health Science, Kio University, Nara, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Osumi', 'Affiliation': 'Neuro Rehabilitation Research Center, Kio University, Nara, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Morioka', 'Affiliation': 'Department of Neurorehabilitation, Graduate School of Health Science, Kio University, Nara, Japan.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny290']
2949,31226922,Dysphagia screening and risks of pneumonia and adverse outcomes after acute stroke: An international multicenter study.,"BACKGROUND


Dysphagia is associated with aspiration pneumonia after stroke. Data are limited on the influences of dysphagia screen and assessment in clinical practice.
AIMS


To determine associations between a ""brief"" screen and ""detailed"" assessment of dysphagia on clinical outcomes in acute stroke patients.
METHODS


A prospective cohort study analyzed retrospectively using data from a multicenter, cluster cross-over, randomized controlled trial (Head Positioning in Acute Stroke Trial [HeadPoST]) from 114 hospitals in nine countries. HeadPoST included 11,093 acute stroke patients randomized to lying-flat or sitting-up head positioning. Herein, we report predefined secondary analyses of the association of dysphagia screening and assessment and clinical outcomes of pneumonia and death or disability (modified Rankin scale 3-6) at 90 days.
RESULTS


Overall, 8784 (79.2%) and 3917 (35.3%) patients were screened and assessed for dysphagia, respectively, but the frequency and timing for each varied widely across regions. Neither use of a screen nor an assessment for dysphagia was associated with the outcomes, but their results were compared to ""screen-pass"" patients, those who failed had higher risks of pneumonia (adjusted odds ratio [aOR] = 3.00, 95% confidence interval [CI] = 2.18-4.10) and death or disability (aOR = 1.66, 95% CI = 1.41-1.95). Similar results were evidence for the results of an assessment for dysphagia. Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72-9.54).
CONCLUSIONS


Failing a dysphagia screen is associated with increased risks of pneumonia and poor clinical outcome after acute stroke. Further studies concentrate on determining the effective subsequent feeding actions are needed to improve patient outcomes.",2020,"Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72-9.54).
","['acute stroke', 'acute stroke patients', '114 hospitals in nine countries', '11,093 acute stroke patients']","['lying-flat or sitting-up head positioning', 'brief"" screen and ""detailed"" assessment of dysphagia', 'HeadPoST']","['death or disability', 'Dysphagia screening and risks of pneumonia and adverse outcomes', 'dysphagia', 'risks of pneumonia', 'dysphagia screening and assessment and clinical outcomes of pneumonia and death or disability']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0560837', 'cui_str': 'Does sit up (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",11093.0,0.14061,"Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72-9.54).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Boaden', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health (Sydney) Australia, Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service-Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019858778']
2950,31796259,Effect of industrial point-source air pollutants on fractional exhaled nitric oxide in healthy volunteers.,"BACKGROUND


Few studies have examined the effects of industrial, fixed-site sources of air pollution on lung inflammation in nearby residents. We investigated the effects of short-term exposure to ambient air near a steel plant on the fractional exhaled concentration of nitric oxide (FeNO), a measure of airway inflammation, in healthy volunteers.
METHODS


A cross-over study design was used. Fifty-nine non-smoking participants (mean age 24 years) were randomly assigned to each of two 5-day exposure scenarios: breathing ambient air adjacent to a steel plant or 5 km away at a college campus site. FeNO and on-site air pollutants were measured daily. Mixed effects linear regression models were used for data analysis, adjusting for sex, temperature, humidity and day of week.
RESULTS


Compared with the college site, PM  2.5 , ultrafine PM, SO 2 , NO 2  and CO levels were significantly greater near the steel plant. FeNO was 15.3% (95% CI, 6.6%, 24.8%) higher near the plant compared to the college site.
CONCLUSIONS


Exposure to ambient air near a steel plant was associated with increased airway inflammation as measured by exhaled nitric oxide.",2020,"CONCLUSIONS


Exposure to ambient air near a steel plant was associated with increased airway inflammation as measured by exhaled nitric oxide.","['nearby residents', 'Fifty-nine non-smoking participants (mean age 24 years', 'healthy volunteers']","['industrial point-source air pollutants', '5-day exposure scenarios: breathing ambient air adjacent to a steel plant or 5\xa0km away at a college campus site', 'short-term exposure to ambient air near a steel plant']","['CO levels', 'airway inflammation', 'fractional exhaled nitric oxide', 'FeNO']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0001869', 'cui_str': 'Air Pollutants'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0038239', 'cui_str': 'Steel'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",,0.0245364,"CONCLUSIONS


Exposure to ambient air near a steel plant was associated with increased airway inflammation as measured by exhaled nitric oxide.","[{'ForeName': 'Sabit', 'Initials': 'S', 'LastName': 'Cakmak', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kauri', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Mamun', 'Initials': 'M', 'LastName': 'Mahmud', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Shutt', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Rigden', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Premkumari', 'Initials': 'P', 'LastName': 'Kumarathasan', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Vincent', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Errol M', 'Initials': 'EM', 'LastName': 'Thomson', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dales', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Canada. Electronic address: r.dales@canada.ca.'}]",Environmental research,['10.1016/j.envres.2019.108965']
2951,31676303,Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes.,"OBJECTIVES


The purpose of this study was to explore potential mediators of the effects of canagliflozin on heart failure in the CANVAS Program (CANagliflozin cardioVascular Assessment Study; NCT01032629 and CANagliflozin cardioVascular Assessment Study-Renal; NCT01989754).
BACKGROUND


Canagliflozin reduced the risk of heart failure among patients with type 2 diabetes in the CANVAS Program. The mechanism of protection is uncertain.
METHODS


The percentages of mediating effects of 19 biomarkers were determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the biomarker of interest. Multivariable analyses were used to assess the joint effects of biomarkers that mediated most strongly in univariable analyses.
RESULTS


Early changes after randomization in levels of 3 biomarkers (urinary albumin:creatinine ratio, serum bicarbonate, and serum urate) were identified as mediating the effect of canagliflozin on heart failure. Average post-randomization levels of 14 biomarkers (systolic blood pressure, low-density lipoprotein and high-density lipoprotein cholesterol, total cholesterol, urinary albumin:creatinine ratio, weight, body mass index, gamma glutamyltransferase, hematocrit, hemoglobin concentration, serum albumin, erythrocyte concentration, serum bicarbonate, and serum urate) were identified as significant mediators. Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%). In a parsimonious multivariable model, erythrocyte concentration, serum urate, and urinary albumin:creatinine ratio were the 3 biomarkers that maximized cumulative mediation (102%).
CONCLUSIONS


A diverse set of potential mediators of the effect of canagliflozin on heart failure were identified. Some mediating effects were anticipated, whereas others were not. The mediators that were identified support existing and novel hypothesized mechanisms for the prevention of heart failure with sodium glucose cotransporter 2 inhibitors.",2020,"Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%).","['Patients With Type 2 Diabetes', 'patients with type 2 diabetes in the CANVAS Program']","['canagliflozin', 'Canagliflozin']","['erythrocyte concentration, serum urate, and urinary albumin:creatinine ratio', 'Average post-randomization levels of 14 biomarkers (systolic blood pressure, low-density lipoprotein and high-density lipoprotein cholesterol,\xa0total cholesterol, urinary albumin:creatinine ratio, weight, body mass index, gamma glutamyltransferase, hematocrit, hemoglobin concentration, serum albumin, erythrocyte concentration, serum bicarbonate, and serum urate', 'Heart\xa0Failure', 'serum urate', 'levels of 3 biomarkers (urinary albumin:creatinine ratio, serum bicarbonate, and serum urate', 'hemoglobin concentration', 'heart failure', 'risk of heart failure', 'erythrocyte concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0350024,"Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%).","[{'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Liberation Army General Hospital, Beijing, China; Department of Cardiology, Xinqiao Hospital, Army Military Medical University, Chongqing, China; George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; University of Oxford, Oxford, United Kingdom; Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, Sydney, New South Wales, Australia; Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vercruysse', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, Raritan, New Jersey.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia; Imperial College London, London, United Kingdom. Electronic address: bneal@georgeinstitute.org.au.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.004']
2952,31780277,"Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial.","BACKGROUND


Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients.
METHODS


In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete.
FINDINGS


Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up.
INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.
FUNDING


American College of Gastroenterology.",2020,"INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients.","['high-risk patients', '1037 eligible patients', 'enrolled patients from six tertiary medical centres in the USA', 'Eligible patients were those at high risk for the development of pancreatitis after ERCP', 'Between July 9, 2013, and March 22, 2018']","['rectal indometacin', 'placebo suppository', 'Rectal indometacin dose escalation', 'endoscopic retrograde cholangiopancreatography', 'endoscopic retrograde cholangiopancreatography (ERCP', 'placebo', 'indometacin', 'indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories', 'additional 50 mg indometacin suppository', 'standard-dose (n=515) or high-dose indometacin']","['acute kidney injury', 'frequency and severity of pancreatitis', 'transient ischaemic attack', 'development of pancreatitis after ERCP', 'Clinically significant bleeding', 'Pancreatitis after ERCP', 'allergic reactions or deaths', 'ST elevation myocardial infarction']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]",1037.0,0.367675,"INTERPRETATION


Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients.","[{'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Fogel', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA. Electronic address: efogel@iu.edu.'}, {'ForeName': 'Glen A', 'Initials': 'GA', 'LastName': 'Lehman', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tarnasky', 'Affiliation': 'University of Texas Southwestern, Digestive Health Associates of Texas, Dallas, TX, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Cote', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Suzette E', 'Initials': 'SE', 'LastName': 'Schmidt', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Akbar K', 'Initials': 'AK', 'LastName': 'Waljee', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Watkins', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Richard S Y', 'Initials': 'RSY', 'LastName': 'Kwon', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Grace H', 'Initials': 'GH', 'LastName': 'Elta', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Easler', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Pleskow', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Ihab I', 'Initials': 'II', 'LastName': 'El Hajj', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA; Division of Gastroenterology, University of Balamand, Beirut, Lebanon.'}, {'ForeName': 'Nalini M', 'Initials': 'NM', 'LastName': 'Guda', 'Affiliation': ""Division of Gastroenterology, University of Wisconsin, Milwaukee, WI, USA; Aurora St Luke's Medical Center, Milwaukee, WI, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Gromski', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'McHenry', 'Affiliation': 'Division of Gastoenterology and Hepatology, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Arol', 'Affiliation': 'University of Texas Southwestern, Digestive Health Associates of Texas, Dallas, TX, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Korsnes', 'Affiliation': 'Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alejandro L', 'Initials': 'AL', 'LastName': 'Suarez', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA; Division of Gastroenterology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Division of Gastroenterology, University of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hofbauer', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30337-1']
2953,31985173,Sexism Interacts with Patient-Physician Gender Concordance in Influencing Patient Control Preferences: Findings from a Vignette Experimental Design.,"BACKGROUND


Patient preferences regarding their involvement in shared treatments decisions is fundamental in clinical practice. Previous evidences demonstrated a large heterogeneity in these preferences. However, only few studies have analysed the influence of patients' individual differences, contextual and situational qualities, and their complex interaction in explaining this variability.
METHODS


We assessed the role of the interaction of patient's sociodemographic and psychological factors with a physician's gender. Specifically, we focused on patient gender and attitudes toward male or female physicians. One hundred fifty-three people participated in this randomised controlled study and were randomly assigned to one of two experimental conditions in which they were asked to imagine discussing their treatment with a male and a female doctor.
RESULTS


Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
CONCLUSIONS


In conclusion, patients' attitudes toward the physicians' gender constitutes a relevant characteristic that may influence the degree of control patients want to have and the overall patient-physician relationship.",2020,"RESULTS


Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
","['patient gender and attitudes toward male or female physicians', 'One hundred fifty-three people participated', 'Patient Control Preferences']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",[],[],153.0,0.0465349,"RESULTS


Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Monzani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vergani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia Francesca Maria', 'Initials': 'SFM', 'LastName': 'Pizzoli', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Marton', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Ketti', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bailo', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Messori', 'Affiliation': 'Department of Oncology and Hemato-oncology, University of Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pancani', 'Affiliation': 'Department of Psychology, University of Milan - Bicocca, Milan, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Cattelan', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12193']
2954,31955429,Nutritional ketosis improves exercise metabolism in patients with very long-chain acyl-CoA dehydrogenase deficiency.,"A maladaptive shift from fat to carbohydrate (CHO) oxidation during exercise is thought to underlie myopathy and exercise-induced rhabdomyolysis in patients with fatty acid oxidation (FAO) disorders. We hypothesised that ingestion of a ketone ester (KE) drink prior to exercise could serve as an alternative oxidative substrate supply to boost muscular ATP homeostasis. To establish a rational basis for therapeutic use of KE supplementation in FAO, we tested this hypothesis in patients deficient in Very Long-Chain acyl-CoA Dehydrogenase (VLCAD). Five patients (range 17-45 y; 4 M/1F) patients were included in an investigator-initiated, randomised, blinded, placebo-controlled, 2-way cross-over study. Patients drank either a KE + CHO mix or an isocaloric CHO equivalent and performed 35 minutes upright cycling followed by 10 minutes supine cycling inside a Magnetic Resonance scanner at individual maximal FAO work rate (fatmax; approximately 40% VO 2  max). The protocol was repeated after a 1-week interval with the alternate drink. Primary outcome measures were quadriceps phosphocreatine (PCr), Pi and pH dynamics during exercise and recovery assayed by in vivo  31  P-MR spectroscopy. Secondary outcomes included plasma and muscle metabolites and respiratory gas exchange recordings. Ingestion of KE rapidly induced mild ketosis and increased muscle BHB content. During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE + CHO than CHO. These results provide a rational basis for future clinical trials of synthetic ketone ester supplementation therapy in patients with FAO disorders. Trial registration: ClinicalTrials.gov. Protocol ID: NCT03531554; METC2014.492; ABR51222.042.14.",2020,"During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE+CHO than CHO.
","['patients with fatty acid oxidation (FAO) disorders', 'patients deficient in Very Long-Chain acyl-CoA Dehydrogenase (VLCAD', 'Five patients (range 17-45 y; 4M/1F) patients', 'patients with very long-chain acyl-CoA dehydrogenase deficiency', 'patients with FAO disorders']","['placebo', 'ketone ester (KE) drink', 'synthetic ketone ester supplementation therapy', 'KE+CHO mix or an isocaloric CHO equivalent and performed 35 min upright cycling followed by 10 minutes supine cycling inside a Magnetic Resonance scanner', 'KE supplementation', 'Nutritional ketosis']","['exercise metabolism', 'plasma and muscle metabolites and respiratory gas exchange recordings', 'quadriceps phosphocreatine (PCr), Pi and pH dynamics during exercise and recovery assayed by in vivo  31  P-MR spectroscopy', 'VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio', 'mild ketosis and increased muscle BHB content']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456270', 'cui_str': 'Fatty acid oxidation disorder'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0065170', 'cui_str': 'Very-Long-Chain Acyl-CoA Dehydrogenase'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3887523', 'cui_str': 'Acadvl'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0014898', 'cui_str': 'Esters'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1735596', 'cui_str': 'Supplementation therapy'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.165283,"During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE+CHO than CHO.
","[{'ForeName': 'Jeannette C', 'Initials': 'JC', 'LastName': 'Bleeker', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Gepke', 'Initials': 'G', 'LastName': 'Visser', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Ferdinandusse', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ferdinand H', 'Initials': 'FH', 'LastName': 'de Haan', 'Affiliation': 'ACHIEVE, Center for Applied Research, Faculty of Health, University of Applied Sciences Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Riekelt H', 'Initials': 'RH', 'LastName': 'Houtkooper', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lodewijk', 'Initials': 'L', 'LastName': 'IJlst', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irene L', 'Initials': 'IL', 'LastName': 'Kok', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Langeveld', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W Ludo', 'Initials': 'WL', 'LastName': 'van der Pol', 'Affiliation': 'Department of Neurology and Neurosurgery, Rudolf Magnus Institute of Neuroscience, Spieren voor Spieren Kindercentrum, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Monique G M', 'Initials': 'MGM', 'LastName': 'de Sain-van der Velden', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sibeijn-Kuiper', 'Affiliation': 'Neuroimaging Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Takken', 'Affiliation': 'Center for Child Development & Exercise, Department of Medical Physiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ronald J A', 'Initials': 'RJA', 'LastName': 'Wanders', 'Affiliation': ""Department of Metabolic Diseases, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'van Weeghel', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frits A', 'Initials': 'FA', 'LastName': 'Wijburg', 'Affiliation': ""Department of Metabolic Diseases, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Luc H', 'Initials': 'LH', 'LastName': 'van der Woude', 'Affiliation': 'Human Movement Sciences, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rob C I', 'Initials': 'RCI', 'LastName': 'Wüst', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pete J', 'Initials': 'PJ', 'LastName': 'Cox', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jeroen A L', 'Initials': 'JAL', 'LastName': 'Jeneson', 'Affiliation': 'Neuroimaging Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12217']
2955,31965646,Effects of a nutrient-dense formula compared with a post-discharge formula on post-discharge growth of preterm very low birth weight infants with extrauterine growth retardation: a multicentre randomised study in China.,"BACKGROUND


Post-discharge optimal growth and nutritional intake have beneficial effects for neurodevelopment in preterm very low birth weight infants (VLBWIs) with extrauterine growth retardation (EUGR). The present study aimed to compare the effects of a nutrient-dense formula (NDF) to a post-discharge formula (PDF) on post-discharge growth of preterm VLBWIs with EUGR.
METHODS


Forty-eight preterm VLBWIs with EUGR at discharge were randomised to receive NDF (100 kcal per 100 mL; 2.6 g protein per 100 mL) or PDF (74 kcal per 100 mL; 1.95 g protein per 100 mL) for 1-6 months until body weight reached the 50th percentile on growth charts with corrected age. Volume, nutrient intake, anthropometry and biochemistry data were collected.
RESULTS


Volume intake was lower in the NDF group than the PDF group during the first 2 months of feeding (P = 0.039 and 0.018, respectively).There were no significant differences in volume intake during months 2-6 of feeding. Energy, protein, carbohydrate and fat intake were higher in the NDF group during months 1-6 of feeding. There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups. The △length Z-score from discharge to month 6 was significantly higher in the NDF group than the PDF group (P = 0.043). No differences existed between the two groups with respect to biochemistry.
CONCLUSIONS


After discharge, preterm VLBWIs with EUGR fed a NDF gain anthropometric parameter Z-scores similar to those for a PDF within 6 months of follow-up. A NDF leading to gain in length requires further follow-up.",2020,"There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups.","['preterm very low birth weight infants with extrauterine growth retardation', 'Forty-eight preterm VLBWIs with EUGR at discharge', 'preterm very low birth weight infants (VLBWIs) with extrauterine growth retardation (EUGR']","['nutrient-dense formula compared with a post-discharge formula', 'PDF', 'nutrient-dense formula (NDF) to a post-discharge formula (PDF', 'NDF']","['volume intake', 'weight, length, and head circumference Z-scores', 'Volume intake', 'Volume, nutrient intake, anthropometry and biochemistry data', 'Energy, protein, carbohydrate and fat intake', '△length Z-score from discharge to month 6']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0151686', 'cui_str': 'Growth retardation (morphologic abnormality)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0708289,"There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups.","[{'ForeName': 'M-X', 'Initials': 'MX', 'LastName': 'Yu', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangdong, China.'}, {'ForeName': 'S-Q', 'Initials': 'SQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangdong, China.'}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, The Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China.'}, {'ForeName': 'X-M', 'Initials': 'XM', 'LastName': 'Tong', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'S-J', 'Initials': 'SJ', 'LastName': 'Yue', 'Affiliation': 'Department of Neonatology, Xiangya Hospital Central South University, Hunan, China.'}, {'ForeName': 'L-P', 'Initials': 'LP', 'LastName': 'Shi', 'Affiliation': ""Department of Neonatology, The Chidlren's Hospital Zhejiang University School of Medicine, Zhejiang, China.""}, {'ForeName': 'D-M', 'Initials': 'DM', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatrics, Quanzhou Women's and Children's Hospital, Fujian, China.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, First Affiliated Hospital of Kunming Medical University, Yunnan, China.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12733']
2956,30880443,Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program.,"BACKGROUND


Different approaches to safety event collection influence the determination of liver toxicity within drug development programs. Herein, a description of how fasiglifam-induced liver injury was detected is provided.
METHODS


This eight-trial drug development program was intended to evaluate fasiglifam (25 mg, 50 mg) against placebo or active comparators (glimepiride, sitagliptin) in approximately 11,000 suboptimally controlled patients with type 2 diabetes (terminated Dec 2013 due to liver toxicity). Liver safety had been pre-identified as a concern, and within the phase 3 trials, was measured through (1) adverse event reporting, (2) central predefined liver monitoring schedule with various thresholds for potential drug-induced liver injury, and (3) blinded adjudication of serious liver toxicity by a panel of experts in drug-induced liver injury. A single data monitoring committee provided safety oversight across all trials within the program.
FINDINGS


Prior to program termination, 7595 of 7602 (99.9%) randomized participants across the eight trials received at least one dose of the study drug (fasiglifam, placebo, or active control). No concerning trends were noted in adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events as reported by local site investigators. However, the predefined central liver safety measurements revealed a greater frequency of possible Hy's Law cases (5 vs 2) and a 3- to 7-fold greater relative risk in alanine or aspartate transaminase elevation (with respect to upper limit of normal) within fasiglifam recipients compared with placebo/active control: alanine or aspartate transaminase > 3×: relative risk 3.34 (95% confidence interval 2.29-4.90), alanine or aspartate transaminase > 5×: relative risk 6.60 (95% confidence interval 3.03-14.38), alanine or aspartate transaminase > 8×: relative risk 6.14 (95% confidence interval 2.18-17.27), and alanine or aspartate transaminase > 10×: relative risk 6.74 (95% confidence interval 2.05, 22.14). All elevations resolved on study drug discontinuation. Drug-induced liver injury was adjudicated as highly likely or probably related in 0.64% of fasiglifam-treated versus 0.06% placebo or active control-treated patients.
CONCLUSION


In spite of clear liver toxicity detected with a systematic surveillance program, liver safety signals were not identified from investigator adverse event reporting alone. By integrating key safety monitoring processes within the randomized design of adequately sized clinical trials, the rare but serious liver toxicity signal became clear, leading to timely program termination.",2019,"No concerning trends were noted in adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events as reported by local site investigators.","['approximately 11,000 suboptimally controlled patients with type 2 diabetes (terminated Dec 2013 due to liver toxicity']","['placebo or active comparators (glimepiride, sitagliptin', 'placebo, or active control', 'placebo']","['Liver safety', 'alanine or aspartate transaminase', 'relative risk in alanine or aspartate transaminase elevation', 'adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events', 'liver toxicity']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.559646,"No concerning trends were noted in adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events as reported by local site investigators.","[{'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Shavadia', 'Affiliation': '1 Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': '1 Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Xiangqiong', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': '1 Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': '3 School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'DeLeve', 'Affiliation': '4 Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': '5 Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Home', 'Affiliation': '6 Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Eckel', 'Affiliation': '7 Division of Endocrinology, Metabolism & Diabetes, University of Colorado, Boulder, CO, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Watkins', 'Affiliation': '8 Institute for Drug Safety Sciences, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': '1 Duke Clinical Research Institute, Durham, NC, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519836766']
2957,30278457,Effect of Fluoride Toothpaste Containing Nano-Sized Sodium Hexametaphosphate on Enamel Remineralization: An in situ Study.,"OBJECTIVE


To evaluate the remineralizing potential of a conventional toothpaste (1,100 ppm F) supplemented with nano-sized sodium hexametaphosphate (HMPnano) in artificial caries lesions in situ.
DESIGN


This double-blinded crossed study was performed in 4 phases of 3 days each. Twelve subjects used palatal appliances containing 4 bovine enamel blocks with artificial caries lesions. Volunteers were randomly assigned into the following treatment groups: no F/HMP/HMPnano (Placebo); 1,100 ppm F (1100F); 1100F plus 0.5% micrometric HMP (1100F/HMP) and 1100F plus 0.5% nano-sized HMP (1100F/HMPnano). Volunteers were instructed to brush their natural teeth with the palatal appliances in the mouth for 1 min (3 times/day), so that blocks were treated with natural slurries of toothpastes. After each phase, surface hardness post-remineralization (SH2), integrated recovery of subsurface hardness (ΔIHR), integrated mineral recovery (ΔIMR) and enamel F concentration were determined. Data were submitted to analysis of variance and Student-Newman-Keuls' test (p < 0.001).
RESULTS


Enamel surface became 42% harder when treated with 1100F/HMPnano in comparison with 1100F (p < 0.001). Treatment with 1100F/HMP and 1100F/HMPnano promoted an increase of ∼23 and ∼87%, respectively, in ΔIHR when compared to 1100F (p < 0.001). In addition, ΔIMR for the 1100F/HMPnano was ∼75 and ∼33% higher when compared to 1100F and 1100F/HMP respectively (p < 0.001). Enamel F uptake was similar among all groups except for the placebo (p < 0.001).
CONCLUSION


The addition of 0.5% HMPnano to a conventional fluoride toothpaste was able to promote an additional remineralizing effect of artificial caries lesions.",2019,"RESULTS


Enamel surface became 42% harder when treated with 1100F/HMPnano in comparison with 1100F (p < 0.001).","['Enamel Remineralization', 'Twelve subjects used palatal appliances containing 4 bovine enamel blocks with artificial caries lesions', 'artificial caries lesions in situ']","['no F/HMP/HMPnano (Placebo); 1,100 ppm F (1100F); 1100F plus 0.5% micrometric HMP (1100F/HMP) and 1100F plus 0.5% nano-sized HMP (1100F/HMPnano', 'Containing Nano-Sized Sodium Hexametaphosphate', 'placebo', 'conventional fluoride toothpaste', 'Fluoride Toothpaste', '1100F/HMP and 1100F/HMPnano', 'conventional toothpaste (1,100 ppm F) supplemented with nano-sized sodium hexametaphosphate (HMPnano']","['surface hardness post-remineralization (SH2), integrated recovery of subsurface hardness (ΔIHR), integrated mineral recovery (ΔIMR) and enamel F concentration', 'Enamel F uptake']","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0243112'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}]","[{'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0074759', 'cui_str': 'sodium polymetaphosphate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.149172,"RESULTS


Enamel surface became 42% harder when treated with 1100F/HMPnano in comparison with 1100F (p < 0.001).","[{'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Danelon', 'Affiliation': 'Department of Pediatric Dentistry and Public Health, São Paulo State University (UNESP), School of Dentistry, Araçatuba, Brazil, marcelledanelon@hotmail.com.'}, {'ForeName': 'Luhana G', 'Initials': 'LG', 'LastName': 'Garcia', 'Affiliation': 'Department of Pediatric Dentistry and Public Health, São Paulo State University (UNESP), School of Dentistry, Araçatuba, Brazil.'}, {'ForeName': 'Juliano P', 'Initials': 'JP', 'LastName': 'Pessan', 'Affiliation': 'Department of Pediatric Dentistry and Public Health, São Paulo State University (UNESP), School of Dentistry, Araçatuba, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Passarinho', 'Affiliation': 'Department of Pediatric Dentistry and Public Health, São Paulo State University (UNESP), School of Dentistry, Araçatuba, Brazil.'}, {'ForeName': 'Emerson R', 'Initials': 'ER', 'LastName': 'Camargo', 'Affiliation': 'LIEC-Department of Chemistry, Federal University of São Carlos (UFSCar), São Carlos/ São Paulo, Brazil.'}, {'ForeName': 'Alberto C B', 'Initials': 'ACB', 'LastName': 'Delbem', 'Affiliation': 'Department of Pediatric Dentistry and Public Health, São Paulo State University (UNESP), School of Dentistry, Araçatuba, Brazil.'}]",Caries research,['10.1159/000491555']